&EPA
          United States
          Environmental Protection
          Agency
            Office of Research and
            Development
            Washington DC 20460
EPA/600/R-96/100
September 1996
National Health and
Environmental Effects
Research Laboratory
               1995 Annual Report
                 Advancing Knowledge for a Purpose

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United States Environmental Protection Agency

     Office of Research and Development
            Washington DC 20460

             EPA/600/R-96/100
               September 1996
    National Health and Environmental

        Effects Research Laboratory

             1995 Annual Report
     Advancing Knowledge for a Purpose
                 U.S. Environmental Protection Agency
                 Region 5, Library (PL-12J)
                 77 West Jackson Boulevard, 12th Floor
                 Chicago, IL 60604-3590

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                                     FOREWORD

       Safeguarding public health and the environment from the adverse consequences of
pollution is the fundamental goal of the U.S. Environmental Protection Agency (EPA). As a
regulatory agency, EPA is responsible for setting emission standards, for regulating toxic
contaminants and formulating sound environmental policy.  Risk assessments and the ensuing
risk management decisions in each of these areas rely on sound scientific evidence linking
pollution sources, environmental exposures, and adverse effects.  Such evidence is provided by
the Agency's Office of Research and Development (ORD), whose role is to strengthen the
scientific foundation for environmental decision making through mission-oriented research.

       The National Health and Environmental Effects Research Laboratory (NHEERL), located
in Research Triangle Park, NC is the research arm of ORD that has the responsibility for the
conduct of a research program on the effects  of contaminants and environmental stressors on
human health and ecosystem vitality. To convey the accomplishments of the NHEERL program,
the accompanying report provides summaries of the contributions made by the NHEERL to the
peer-reviewed literature during fiscal year 1995. A full listing of the scientific papers
published/accepted for publication is also provided.

       A major component of NHEERL's mission is the conduct of peer-reviewed research that
improves the Agency's ability to assess human and ecological  health risks. To achieve this
goal, the NHEERL risk-based research program has three major elements:
4      the development of state-of-the-art methods that facilitate the identification and
       characterization of hazard;
*      the development of predictive models  for application to  the quantitative assessment of
       risk; and
*      the application of these methods and models to collect scientific data (measurement) on
       specific problems identified by the regulatory programs  and other environmental
       stakeholders.

       Since NHEERL has the dual responsibilities of conducting  research to support directly
the needs of the Agency's regulatory offices (e.g., Air, Water) and  regions while also advancing
the science to improve the risk assessment process, in general, this  report is complied along  two
dimensions. The programmatic (media) sections summarize NHEERL's contributions to
programmatically relevant issues within EPA,  discussing the ways in which the information is
useful to our client offices and risk assessment. The division-specific sections address the
NHEERL's research from disciplinary perspective based on the specialized fields of
environmental health or ecology research of its Divisions.

       We hope  that you will find the information presented here to be useful in understanding
the way in which  NHEERL integrates Agency  needs with scientific priorities while applying its
diverse scientific  capabilities to advance scientific and technological  progress in areas of
environmental and public health.
                                                         YI*> —
                                              Lawrence W. Reiter, Ph.D.
                                              Director, NHEERL

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                                                                  NHEERL FY95 ANNUAL REPORT
National Health and Environmental Effects Research Laboratory	  I
       Mission and Goals  	  3
       Organizational Structure	  5
       Purpose of this Report	  5

NHEERL Media Programs	  7
   Air Program  	  9
       Air Toxics  	  12
       Indoor Air  	  13
       Global Change	  14
       Conclusions	  16
   Multimedia Research Program	  17
       Human Health Risk Assessment  	  18
       Ecological  Risk Assessment	  21
       Conclusion	  23
   Pesticides and Toxics Research Program	  25
       Methods  	  26
       Models	  27
       Chemical-Specific Data	  27
       Conclusion	  28
   Waste Research Program 	  29
       Bioremediation  	  30
       Improved Risk Assessment at Waste Sites	  31
       Toxicity Evaluation of Agents Frequently Found at Waste Sites  	  31
       Conclusion	  33
   Water Program  	  35
       Water Quality  	  35
       Drinking Water  	  39

NHEERL Ecology Divisions	  41
   Atlantic Ecology Division 	  43
       Ecosystem Health  and Integrity	  44
       Ecological Significance and Extrapolation Ecology	  45
       Ecological Risk Assessment	  46
       Biological Availability and Ecological Effects in Aquatic Systems  	  47
       Global Change Issues (Ozone, UV-B, and the Carbon Cycle)	  49
   Gulf Ecology Division  	  53
       Developing Test Methods	  54
       Biological Indicators of Ecological Condition	  55
       Development and Validation of Models	  56
       Microbial Ecology  	  58
   Mid-Continent Ecology Division 	  63
       Mechanisms of Toxicity	  64
       Dosimetry	  65
        Reproductive and  Developmental Toxicology	  66
        Chemical  Mixtures and Multiple Stressors	  66

ADVANCING KNOWLEDGE FOR A PURPOSE                                                          i

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 NHEERL FY95 ANNUAL REPORT
       Measuring and Predicting the Responses of Aquatic Ecosystems	  68
       Watershed Characterization	  69
   Western Ecology Division	  73
       Ozone Considerations	  74
       Risk Assessment Issues  	  75

NHEERL Health Divisions 	  81
   Environmental Carcinogenesis Division 	  83
       Hazard Assessment	  85
       Biomarkers  	  85
       Disinfection By-products, PAH, and Chemical Mixtures	  86
       Dose Response Assessment (BBDR Models)  	  87
   Experimental Toxicology Division  	  91
       Hazard Identification	  93
       Dose-Response Relationships  	  94
       Quantitative Models 	  95
   Human Studies Division	  99
       Sensitive Subpopulations (Asthmatics)	  101
       Respiratory Effects of Air Pollutants 	  102
       Biomarkers of Human Exposure, Dose, and Early Molecular Effects 	  103
       Dosimetry of Particles and Gases  	  104
       Biologically Based Dose-Response (BBDR) Models	  105
       The Teplice Project	  106
       Sensitive Subpopulations (Asthmatics)	  109
   Neurotoxico/ogy Division  	  Ill
       Hazard Identification	  112
       Dose-Response Assessment  	  114
       Chemical Specific Data 	  115
       Hazard Identification	  119
   Reproductive Toxicology Division  	  123
       Development of BBDR Models	  125
       Endocrine Disruption 	  127
       Reproductive Effects of Drinking Water Disinfection By-Products	  129
       Improvements in Reproductive Toxicity Test Methods 	  130
       Improvements in Noncancer Dose-Response Assessment	  131
       Developmental Toxicity of Complex Mixtures	  132

References 	  135
                                                           ADVANCING KNOWLEDGE FOR A PURPOSE

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                                                                           NHEERL FY95 ANNUAL REPORT
                                                                                       INTRODUCTION
Introduction
Research conducted under the direction
of the agency's Office of Research and
Development (ORD) provides decision-
makers with a sound technical basis for
the  formulation  of  environmental
policies and programs.  ORD's National
Health   and   Environmental   Effects
Research Laboratory, headquartered in
Research Triangle Park, NC, plays a vital
role in this mission.

NHEERL is the agency's focal point for
scientific research  on  the  effects  of
contaminants and environmental stressors
on human health and ecosystem integrity.
Its research helps the agency understand
the processes that cause pollution and
evaluate the risks that pollution poses to
humans and ecosystems. The impact of
its efforts is felt beyond the agency as
well, enabling state  and  local govern-
ments  to  implement  more effective
environmental  programs, assisting the
industrial sector in setting and achieving
environmental  goals,  and  informing
international governments  and  organi
zations  in   issues  of  environmental
importance.

NHEERL's  primary  function  is   to
conduct research that supports the
agency's   mandate,   which  includes
statutory obligations. It's more singular
role is to improve the agency's ability to
assess  health and ecological risk  by
strengthening the scientific basis for risk
assessment. To fulfill its responsibilities,
NHEERL maintains focused, yet diversi-
fied, research program that works to re-
duce the uncertainties inherent in
regulatory  risk  assessment.   These
uncertainties  vary  in   scope  from
fundamental scientific questions (which
require  the discipline  of a sustained
research strategy) to Congressionally
mandated investigations (which demand
a more immediate response).

Accordingly, NHEERL strikes a balance
between long-term and  short-term
studies,  combining elements of both
basic and applied sciences to provide a
unique blend  of research capabilities.
NHEERL's long-term studies confront
persistent and difficult issues,  such as
global climate change or the relationship
between   airborne   particles   and
increased rates of respiratory illness.  It's
short-term projects, on the other hand,
are   shaped    by  more   pressing
imperatives;  for   example,   when
complaints of illness coincided with the
use of oxygenated gasoline in certain
regions of the country, NHEERL quickly
initiated clinical studies of a fuel  additive
suspected of causing the adverse effects.
Effective   coordination    of   these
complementary  capabilities   enables
NHEERL to respond in  a  timely and
comprehensive   manner  to  widely
divergent Agency needs. NHEERL  is
organized into nine  divisions,  each of
which specializes in a different field of
environmental   health   or   ecology
research (Figure I). NHEERL is able to
sustain  a  fluid  program  that offers
specialized skills in many distinct areas
while  retaining  sufficient flexibility to
adapt to changing research priorities.
          National
      Health and
Environmental
             Effects
         Research
      Laboratory
          (NHEERL)

       The U.S. Environmental
Protection Agency (EPA) is one
        of only a few federal
organizations that functions as
       both a scientific and a
         regulatory agency.
ADVANCING KNOWLEDGE FOR A PURPOSE

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 NHEERL FY95 ANNUAL REPORT
INTRODUCTION
The existence of such scientific diversity within a single
organization  is  unique,  and  it  offers   NHEERL  a
competitive edge as it addresses emerging health and
ecological issues.

NHEERL  has  organized  a  cadre of  nationally  and
internationally  recognized   scientific  experts  who
pioneer   innovative  solutions   to   environmental
problems,  provide  leadership and guidance  to the
scientific community, and  lend  technical  advice  in
national  and  international   settings,  often  in  crisis
situations.  On issues ranging from disaster response
(e.g., the Exxon Valdez oil spill) to evaluations of health
        and ecological effects  (e.g., the toxicity of endocrine
        disrupters)  to  risk   assessment  (e.g.,  the  dioxin
        reassessment), NHEERL scientists provide information
        essential to effective decision-making. To augment its
        in-house efforts, NHEERL administers an extramural
        program through cooperative agreements, contracts,
        and  interagency  agreements that  draws upon  the
        expertise  of pre-eminent  researchers in academia,
        industry, and government organizations.  Collectively,
        these  efforts  produce objective,  reliable data that
        provide the scientific foundation for the agency's risk
        assessments and assist in  resolving the most  complex
        environmental issues.
                                    .   , _
                                i   National Exposure
                                i  _    . ,  I
                                i  Research Laboratory
                                       NFRL
                                       NERL
                                1
                    National Risk
                 Management Research
                     Laboratory
                      NRMRL
                                                  National Health and
                                                 Environmental Effects
                                                 Research Laboratory
                                                      NHEERL
                       Management
                       Coordination Division
                       Research and
                       Administrative Support
                       Division
Experimental
Carcinogenesis Division
Experimental
Toxicology Division
                                                   Human Studies Division
                                                   Neurotoxicology
                                                   Division
                                                   Reproductive Toxicology
                                                   Division
                                                                           National Center for
                                                                         Env ronmental Research
                                                                          and Quality Assurance
                                                                             NCEHQA
                        Research Planning and
                          Coordination Team

e Deputy
or for
EMENT
'-
!J;
»•
if
—

1
Office of the Associate
Director for
HEALTH



	

Office of the
Directc
ECOL(
Atlantic Ecology Division
Gulf Ecology Division
                            Mid-Continent Ecology
                            Division
                            Western Ecology
                            Division
                Figure /.  Organizational Structure of NHEERL and its Relationship to ORD.
                                                                             ADVANCING KNOWLEDGE FOR A PURPOSE

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                                                                              NHEERL FY95 ANNUAL REPORT
                                                                                          INTRODUCTION
        Mission and Goals
NHEERL's commitment to advance the current state of
knowledge surrounding the effects of contaminants and
other stressors on human health and ecosystem vitality
stems directly from a clear and strategic mission. The
mission statement, described below,  embraces three
goals. Pursuit of these goals enables NHEERL to secure
and  expand its position as a premier environmental
research institution.
  NHEERL's mission is:
  • to perform high quality, peer-reviewed Effects-
    based Research that improves the Agency's
    ability to make decisions about health and
    ecological risk
  • to provide Leadership in the area of
    environmental science, research and assessment
  • to provide scientific and technical Assistance at
    local, state, regional, national and international
    levels
Effects-based Research	
Critical  to the success of NHEERL's   research is a
coherent research strategy.  NHEERL's approach to
research, in accordance with ORD's landmark  1995
Strategic  Plan,  is  founded  on  principles  of risk
assessment.  These principles bring cohesion to the
research, and they provide  mechanism for setting
research priorities and for defining research goals.  In
the area of health effects, NHEERL has adopted the risk
assessment  paradigm  described by   the  National
Academy of Sciences  (NAS)  in  1983 to guide  its
research efforts.  This paradigm consists of 4 steps
(hazard   identification,  dose-response  assessment,
exposure assessment, and risk characterization) that
drive risk management decisions. For ecological effects,
NHEERL's research strategy follows the framework for
ecological risk assessment developed by EPA  in 1992,
consisting   of   problem    formulation,   analysis
(characterization of exposure and effects), and  risk
characterization.

NHEERL conducts risk-based research in three areas
aimed at improving the agency's ability to perform risk
assessments:

• hazard identification  (or problem formulation), which
  focuses on the development of methods that
  demonstrate an association between exposure and
  effects
• dose-response assessment, which seeks to under-
  stand the cascade of events linking exposure to
  effects and then incorporates this information into
  predictive models that can reliably estimate risk
• problem-specific studies, which are designed to fill
  gaps in knowledge on a particular chemical con-
  taminant or environmental condition through
  systematic collection and analysis of scientific
  measurements.
The above efforts equip the agency with the scientific
knowledge and technical tools necessary for improved
evaluation of risk and for more informed regulatory and
policy decisions. For example, NHEERL has developed
neurotoxicity test guidelines as mandated by the Toxic
Substances and Control Act (TSCA)  and toxicity tests
used to derive EPA's Water and  Sediment  Quality
Criteria; it has produced computer models that simulate
the response of ecosystems to  climate change  and
biologically based models that estimate  human risks
from pollutants such as  methanol; and it directs the
Environmental Monitoring and Assessment  Program
(EMAP), in which measurements are gathered  and
analyzed to document  the status of ecosystems and to
depict  ecologically relevant trends, such as land  use
patterns or habitat fragmentation.

Central to research planning and scientific direction is
NHEERL's  multi-disciplinary approach to problem-
solving. Assimilation  and  integration of information
ADVANCING KNOWLEDGE FOR A PURPOSE

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NHEERL FY95 ANNUAL REPORT
INTRODUCTION
across environmental disciplines and  across multiple
levels of biological organization (from molecular to the
whole organism,  and  from  the organism  to  the
ecosystem levels) strengthens analyses of environmental
issues.  Collaborations among scientists  within  and
outside  the  agency   are  encouraged,  providing
opportunities  for harmonization of research efforts.
Orchestrating research activities also leads to more
comprehensive analyses and more efficient expenditure
of resources.

Implicit to a multi-disciplinary approach to research is a
diverse and dynamic workforce.  NHEERL retains a
highly  trained  mix  of  toxicologists,  ecologists,
pathologists,  biologists, physicians, clinicians, physical
scientists,     statisticians,     computer    experts,
epidemiologists,     chemists,     oceanographers,
veterinarians,  and  support staff.   These dedicated
scientists  conduct cutting-edge research  to address
effects-based issues. Microbiologists, for example, are
developing high-tech methods (such as gene probes and
immunoassay) to detect infection caused by pathogens
in drinking water, toxicologists are developing asthmatic
rodents that are helping to explain immune  response to
indoor air pollutants, and   climate  modelers  are
designing computer programs to predict fluctuations in
atmospheric carbon dioxide levels brought on by global
warming.

Also  key to  an effective research program are the
resources available to the  scientists.  Housed in
NHEERL's health  and  ecology research facilities are
chemistry, biology,  toxicology, aquatic,  and  clinical
laboratories  equipped with  highly  specialized  and
technologically advanced  instruments and computer
hardware  and  software.    For testing especially
hazardous materials, NHEERL operates  high hazard
containment facilities in Research Triangle Park, NC,
and in Duluth, MN, that boast advanced worker safety.
Often  the equipment  is  designed  exclusively  by
NHEERL to  meet individual  research needs.   For
example,  NHEERL has  developed  state-of-the-art
inhalation exposure chambers for clinical research on air
pollutants,  it has designed and operates programmable
growth  chambers  for  studying   the  effects  of
environmental stresses on plant and soil processes, and
it  maintains  specially outfitted research  vessels for
marine and freshwater research.

Finally, and  perhaps  most  importantly, NHEERL  is
committed to scientific excellence in the execution of
its mission-oriented research. Rigorous peer review is
required for all major  studies (as  well as research
products, such as manuscripts) to ensure that research
output attains the  highest possible  scientific  and
technical standards.  Research protocols adhere to strict
EPA Quality Assurance (QA) guidelines, assuring the
quality and defensibility of methods and data.

Key scientific management positions are filled with the
help of committees that identify and recruit the most
highly qualified candidates. To optimize the quality of
its in-house program and to stimulate ingenuity among
NHEERL scientists,  a  competition   for  research
funds-similar in procedure to the system used to seek
federal grants-has been developed and instituted within
NHEERL.    For  this  selection process,  research
proposals are solicited  from intramural investigators,
the submissions are peer reviewed for scientific merit
and programmatic relevancy, and the most deserving
projects are awarded funding.

Leadership	
By virtue of their scientific acumen and their national
and international reputations, NHEERL scientists are
recognized  as  leaders in the environmental research
arena and  are actively  involved  in  the scientific
community.   NHEERL scientists hold elected and
appointed  positions  in  professional   and scientific
societies; they are appointed to editorial review boards,
peer  review committees, planning committees, and
advisory boards; they  chair symposia  and scientific
meetings; they author (and review) critical  publications
and  test guidelines; and  they  serve as mentors for
graduate students and as adjunct faculty members  at
major universities across the nation.  The collective
impact  of   these  activities  affords  NHEERL the
opportunity to exert  considerable  influence  on the
                                                                       ADVANCING KNOWLEDGE FOR A PURPOSE

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                                                                              NHEERL FY95 ANNUAL REPORT
                                                                                          INTRODUCTION
direction and priorities of  environmental  research
around the world.

Assistance	
NHEERL recognizes and embraces its duty to provide
assistance to agency programs and to the scientific
community at large. The expertise and agency-oriented
perspective of its scientists place NHEERL in a unique
position to respond to diverse requests for scientific
advice and technical consultation. NHEERL researchers
serve as advisors to EPA Program Offices and Regional
Offices, to other ORD laboratories, to other federal
agencies, and to interagency task forces; they provide
environmental guidance to local, state, native American,
and  international governments; and  they establish
partnerships  with  corporate,  public,  private,  and
educational sectors to disseminate research results and
to provide technical training.  By sharing its skills and
knowledge,  NHEERL enhances the ability of other
organizations  to  safeguard public  health  and  the
environment, and it serves as a catalyst for scientific and
technological progress.
           Organizational Structure
NHEERL  accomplishes  its  mission  through  the
integrated activity of nine research divisions, five of
which focus on human health issues and four of which
focus on ecological issues. The health divisions are
centrally located in Research Triangle Park, NC, while
the  ecology  divisions  are strategically  situated in
ecologically distinct geographic regions across the U.S.
Overall scientific direction is provided by the Office of
the Director for  NHEERL. In addition to the Director,
who oversees and supervises the National  Laboratory,
there exists within this Office

• a Deputy Director for Management, who is
  responsible for oversight of Laboratory operations,
  administrative support, and fiscal resource
  accountability
       Purpose of this Report
The remainder of this document focuses on some of
the scientific and programmatic accomplishments for
FY95, highlighting some of the more than 400
• an Associate Director for Health, who provides
  leadership for the health effects research divisions;
• an Associate Director for Ecology, who provides
  leadership for the ecology effects research divisions
• a Research Planning and Coordination Team,
  whose members serve as liaisons between
• the Laboratory and the regulatory program offices
  in headquarters and who are responsible for the
  strategic planning of programmatically relevant
  research (see Figure I).
These managers bring common direction to NHEERL's
research programs and ensure efficient use of limited
resources.
peer-reviewed  publications  produced by  NHEERL
during FY95, and putting them in context of science and
agency programs.
ADVANCING KNOWLEDGE FOR A PURPOSE

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Overview of NHEERL Media Programs
                                                                          NHEERL FY95 ANNUAL REPORT
                                                                                    MEDIA PROGRAMS
    There  are  five  media  research
    programs,  all located  in Research
Triangle  Park,  NC.  Each  program
addresses a variety of issues within the
context of their media focus. Table I.
Health  Programs Overview  gives  an
example of issues addressed by each
media program.

The  media-specific  sections of  this
report  highlight   some   of   the
accomplishments of the media programs
that  were published  in  the  peer-
reviewed literature  during FY95. The
sections reflect a "snapshot in time" and
focus on the state of the research at that
 Table I. Media Programs Overview
              particular time. NHEERL also provides
              support  to  programs  in  terms of
              technical consultation, review, sharing of
              prepublication  information, or other
              support that may not be reflected in the
              year's peer-reviewed publications.

              NHEERL is preparing a series of reports
              that are specific to each  of the ORD
              subcomponents under which NHEERL
              research is performed. These subcom-
              ponent reports will provide a chrono-
              logical context to  the  research  and
              should complement this annual report.
   MEDIA PROGRAM

   Air

   Multimedia


   Pesticides and Toxics
  Waste (i.e., Super-fund,
  Hazardous Waste, and Oil
  Spills)

  Water
EXAMPLE OF ISSUES ADDRESSED

Sensitivity to ozone exposure: Who is most sensitive and why?

Research results that will lead to improved ecological risk
assessments and human health risk assessments across all media
programs.

Test method, model development, and chemical-specific
issues.
Research data supporting the additivity assumption used by
OSWER at waste site risk assessments

Effects of physical disturbances on urban wetlands quality
        Media

 Programs

The NHEERL media programs
  perform important research
    through all of EPA/ORD's
media-specific programs. The
   summaries provided here
reflect the breadth of NHEERL
           contributions to
       programmatic issues
              within EPA.
ADVANCING KNOWLEDGE FOR A PURPOSE

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                                                                            NHEERL FY95 ANNUAL REPORT
                                                                                          AIR PROGRAM
Introduction
           the research activities of its
    five  health   and  four  ecology
divisions, NHEERL's  air program  has
targeted   four  critical  air  quality
management issues for emphasis. These
significant air-related issues are: Criteria
                      Air Pollutants,  Air Toxics, Indoor Air,
                      and Global Change. Findings from FY95
                      scientific air research on these issues are
                      discussed in the following sections.
fY 1995 Accomplishments
                    Air Pollutants
To protect  public  health  and  the
environment, the Clean Air Act requires
EPA to set National Ambient Air Quality
Standards for six pollutants  (carbon
monoxide, particulate matter (PM), lead,
nitrogen  dioxide, ozone, and  sulfur
oxides), and to review and revise these
standards  regularly.  Agency  decisions
about standards are based largely upon
criteria documents developed  for each
pollutant. NHEERL's research focuses on
topics that will reduce uncertainties and
fill  data  gaps identified  in   previous
criteria   documents.   Our   current
research  emphasis   is  designed  to
improve the scientific basis for regulation
of PM and ozone.
                      Particulate Matter (PM)
                      Recent  epidemiological  data   have
                      suggested greater than expected human
                      morbidity and mortality from exposures
                      to   particulate   matter.   Although
                      associated     with     considerable
                      uncertainties   (Shy   et  al.),   these
                      observations  have  elevated PM  as  a
                      priority research  issue within NHEERL.
                      During FY95, ORD developed a  strategic
                      research plan for PM. NHEERL defined its
                      research projects  to complement ORD's
                      strategic vision, according to the categories
                      identified in Table 2. Particulate Matter
                      Research Focus.
 Table 2. Particulate Matter Research Focus
  Problem
  characterization

  Dosimetry
  Causa)
  mechanisms
Improve problem characterization by providing more detailed analysis of
epidemiology data.

Evaluate dosimetry (exposure-dose relationships) by measuring and
modeling particle deposition in the lungs.

Investigate causal mechanisms by determining the role of PM
                Air

   Program

     The U.S. Environmental
  Protection Agency (EPA) is
   responsible for setting air
      quality standards and
  establishing regulations to
  reduce air pollution. EPA's
National Health and Environ-
    mental Effects Research
       Laboratory (NHEERL)
    supports this strategy by
conducting targeted research
 to help the Office of Air and
   Radiation make informed
   decisions based upon the
      best available science.
ADVANCING KNOWLEDGE FOR A PURPOSE

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NHEERL FY95 ANNUAL REPORT
AIR PROGRAM
Problem Characterization
Environmental epidemiological studies have been limited
by the methods available to characterize accurately either
human exposures or biologically effective dose (Zenick
and Griffith, Lee et al.). NHEERL is conducting extensive
research to understand the links between exposure to
combustion-related  particulates,  biologically  effective
dose, and various health effects. We are beginning to
develop  powerful tools to study and understand  the
effects of particulate exposures in human populations
(Mumford et  al., in press).

Scientists from NHEERL and the Czech Republic have
been collaborating to study the health effects associated
with air pollution in heavily industrialized  Northern
Bohemia, focusing on toxic components associated with
small respirable particles (PM2.5). During  1995,  we
reported our observations that the prevalence and  risk
for respiratory  symptoms  (Hnizdo et  al.),  but  not
neurobehavioral dysfunction (Otto et al., in press) were
elevated in  school  children  as  a function  of their
exposures to respirable particulates.  In addition,  we
found  that personal exposure to  PM2.5 was highly
correlated  with exposures to  carcinogenic  polycyclic
aromatic hydrocarbons  (PAHs) in the air (Binkova et  al.).
These findings will help clarify the relationship between
PM exposures and various health effects (e.g., respiratory
disease, cardiovascular  disease, and cancer).

Dosimetry
Understanding particle  deposition is critical to assessing
the  potential risks to  humans. We have shown that
breathing pattern and  airway resistance are the most
important factors affecting total lung deposition of  fine
particles in normal subjects;  age and gender had only
minor  effects (Bennett et al.; Brown  et al., in  press).
However, preliminary findings indicate that preexisting
lung disease, such as Chronic Obstructive Pulmonary
Disease  (COPD) may  have  substantial impact  on
deposition.

Recent studies have challenged the traditional notion  that
particles deposited in the ciliated airways were cleared
out from the lung within 24 hours, claiming that particles
persisted in the airways for some time. However, we
demonstrated complete clearance of particles from the
large airways of dogs following intrabronchial deposition,
thereby confirming the conventional understanding of
particle clearance kinetics (Lay et al.).

Causal Mechanisms
One of the most  important  questions about  particle
toxicity is: What is it about particles that produces the
toxic effect? The answer to this question will allow policy
makers to predict which  particles are  most likely to
produce problems and why. In turn, they will ensure that
the  appropriate  sources of  particle  emissions  are
targeted for regulation.

During FY95, we characterized and identified substances
present in  particulate air pollution that are capable of
binding metals and demonstrated a relationship between
these substances and the amount of bound metal (Ghio
et al.). We also  published our suggestion  that soluble
metals on the surface of the particles may play a major
role in the observed toxicity.  Comparisons of particles
from different emission sources have indicated that those
with  higher  concentrations  of  soluble  metals  are
associated  with  greater toxicity (Pritchard et al., in
press).

Tropospheric Ozone	
Ozone is a reactive gas that produces irritation of the
lungs. Over the years NHEERL has provided data critical
to evaluating the ozone criteria  set by  EPA. A critical
remaining question about ozone toxicity  is: How  do
individuals differ in their responsiveness to ozone, and
what accounts for the differences? Or,  put differently,
who is most susceptible to the effects of  ozone,  how
much more susceptible are they, and why? Answers to
these questions are multifaceted. During FY95, NHEERL
continued to build EPA's knowledge of ozone  toxicity by
providing a response to key questions identified in Table
3. Key Research Questions on Susceptibility to Ozone
Toxicity.

The Clean Air Act requires EPA to protect the  most
sensitive subpopulations from  the potential  adverse
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                                                                               NHEERL FY95 ANNUAL REPORT
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effects of exposure to air pollutants. To improve our
understanding of how much variability exists  among
individuals in response to ozone exposure, NHEERL
developed a model that describes the proportion of
individuals responding to ozone exposure as a function of
ozone concentration and exposure duration (McDonnell
et al.). This model is important because it can be  used in
risk  and  benefit assessment  for various regulatory
scenarios.

Because   the  predominant  effects   of  ozone  are
respiratory and asthma is a respiratory disease, EPA must
know whether  asthmatics are more sensitive to ozone
than nonasthmatics.  Reports  by NHEERL  in FY95
clarified the issue. Horstman et  al. showed that more
severe  asthmatics  do  indeed  appear to  be  more
susceptfble to ozone than normal subjects, as measured
by lung function. Peden et al. demonstrated that  allergic
asthmatics exposed to ozone experience a different kind
of  inflammation (eosinophilic   driven) than   normal
 Table 3. Key Research Questions on Susceptibility to Ozone
 Toxicity	
  •  How much variability exists between individuals in
     their response to ozone?
  •  Are asthmatics more sensitive to ozone than
     nonasthmatics?
  •  Do other common variables such as age,
     socioeconomic status, or hormonal status (i.e., stage
     of menstrua! cycle) alter ozone's effects on the
     respiratory system?
  •  How can animal data best be used to elucidate risks to
     humans?
subjects (neutrophil driven). Related studies by Ball et al.,
Noah' et al. and  Seal et al. place boundaries on the
interpretation of these observations.  For example, Seal
et al. showed that responsiveness to ozone was greatest
in young adults and decreased with increasing age.
The necessary and complete understanding of ozone's
toxic effects can only be achieved through a combination
of animal and human studies. Some important studies
cannot be carried out on humans. Yet, for animal studies
to be of value, we must know how ozone produces its
toxic effects and how best to extrapolate between animal
and human studies. Several NHEERL publications during
FY95 bring us closer to these goals. Gerrity et al. helped
identify potential sites of ozone damage in the airways.
Highfill and Costa developed exposure-response models
linking spirometric data and permeability of the lung in
humans and animals. Hatch et al. explored extrapolation
between rats and humans, comparing ozone dose and
effects and accounting for the species differences.

In addition to its effects on human health, tropospheric
ozone  may  have  significant  impact  on  terrestrial
ecosystems. During FY95 we showed that while ozone
is the most widespread air pollutant affecting vegetation
in the U.S., its effects on forests vary regionally. This
variation is the result  of differences in wind  patterns
carrying ozone from urban areas, differential sensitivity of
plant  species,  and  differences  in  climate  and  soil
conditions (Hogsett et al.). We found that tropospheric
ozone has a profound effect on the rhizosphere (root
zone of the soil), where it depresses root growth and
mycorrhizal activity (symbiotic activity of fungal mycelium
with roots of a higher plant). Ozone often reduces the
amount of carbohydrate that is allocated to roots and
mycorrhizae,  making  seedlings more susceptible to
nutrient and moisture stress. By adversely affecting the
rhizosphere, ozone effects on forest ecosystems may be
more widespread than previously noted based on foliage
damage. Moreover, ozone stress may magnify the effects
on forests of  increased  temperatures  and  regional
drought predicted to result from global climate change
(Andersen and Rygiewicz, Rygiewicz et al., Wilson et al.).
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      Air Toxics
The Clean Air Act Amendments of 1990 established a list
of 189 toxic air pollutants requiring regulation by EPA.
Initially the Agency must establish maximum achievable
control  technologies for each of the toxic pollutants.
Then, EPA is required to evaluate residual risk for large
industrial sources of toxic air pollution and to identify and
control  the  chemicals that pose the greatest risks to
human  health in  urban areas.  Performing these risk
assessments  is difficult  because of  data gaps  and
uncertainties. NHEERL's research is designed to improve
air toxics risk assessment as indicated in Table 4. Research
Objectives for Air Toxics. Although technically  arduous,
solving  many of the  problems of quantitative risk
evaluation appears  dependent  upon development of
biologically based dose response models (BBDR).

Af a/or sources, urban areas, and risks
During FY95, NHEERL completed the data sets for three
prototype chemicals, a critical step in the development of
prototype models. The goal of this program is to develop
new approaches to air toxics risk assessment, in the
process addressing some of the most difficult assessment
issues  faced by  the  Agency.  The  problematic risk
assessment issues include estimating exposure-response
relationships over a range of exposure concentrations
and durations, predicting the human health impacts of
these exposures, and estimating risk from common air
pollutant mixtures.

  Table 4. Research Objectives for Air Toxics

  Provide prototype data, methods, and models to improve
  air toxics risk assessment. During FY95 NHEERL
  addressed three major air toxic pollutant issues.

  «  Major sources and risks to public health
  *  Health risks from MTBE * Auto fuel oxygenate
  »  Health risks from MetharwJ
Efforts are focused on a list of chemicals and source
categories currently thought to pose the greatest risks
to public health. These are the following health effects
and chemicals classes:
I.   Respiratory Toxicity - Irritant Gases (Selgrade et
     al., Yang et al.)
2.   Neurotoxicity - Solvents (Broadwell et at,
     Croften)
3.   Developmental Toxicity - Non-chlorinated
     Hydrocarbons (Abbott et al., Andrews et al. (see
     mobile sources discussion below)
4.   Cancer - Polycyclic Organic Matter and
     Atmospheric Transformation Products (Nesnow
     et al., Ross et al.).

Mobile sources	
The Clean Air Act mandates that those areas that do not
attain  the  NAAQS for carbon monoxide must add
oxygenates (e.g., MTBE) to auto fuels. The addition of
MTBE coincided with complaints of illness in some parts
of the country, especially in Alaska. Prah et al. demon-
strated that humans exposed to environmentally relevant
concentrations of MTBE in controlled chamber studies
did not report increased symptoms, changes in objective
cognitive measures,  or  physiological changes such  as
respiratory tract inflammation.  This work was key in
allaying some concerns about the potential risks posed by
MTBE and  facilitated the continued use of MTBE  to
control carbon monoxide and its adverse health effects.

Methanol	
Methanol is an important chemical under the Clean Air
Act. It has been proposed as a cleaner burning alternative
fuel for current motor vehicles, it is a likely fuel for fuel
cell technology cars of the future, and it is listed among
the 189 toxic air pollutants. Previously, we showed that
methanol  appears to be particularly toxic during fetal
development, therefore, evaluating the risk posed  by
methanol  is a  high  priority. During  FY95, NHEERL
moved closer to achieving its scheduled development of
the Agency's first BBDR model  for a developmental
toxicity of methanol. We completed work on the toxicity
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of methanol's  principal  metabolite,  formic acid,  in
embryos exposed in an in vitro test system (Andrews et
al.,), and we described patterns of cell death in rat and
mouse  embryos  exposed  to methanol  in  the  same
culture   system   (Abbott   et  al.).   The   research
continues to indicate that methanol is the proximate
developmental toxicant, and to confirm the heightened
sensitivity of the mouse compared to the rat, in terms of
developmental  toxicity. When completed, the BBDR
model will form a foundation for EPA to use in assessing
the health risks posed by methanol.
      indoor Air
Indoor air pollution is often described as posing one of
the  highest  environmental  risks to  human  health.
However, EPA's indoor air program is not regulatory.
The Office of Air and Radiation provides information on
indoor air quality for consumers, building owners and
managers, public health professionals, etc., based in large
part on ORD research results. In its indoor air research,
NHEERL emphasizes an improved understanding of the
health effects of indoor pollutants and pollutant mixtures,
as indicated in Table 5, with special attention to some of
the symptom-based conditions associated with indoor
air.
During  FY95,   NHEERL  reported resolution  of  a
politically charged indoor air problem. Anecdotal reports
suggested an association between emissions from carpets
and a wide array of signs and symptoms. A private testing
firm reported  finding an association between  carpet
emissions and toxicity (respiratory and neurobehavioral)
in mice, which was claimed to validate the anecdotal
reports. However,  NHEERL conducted a study of the
highest quality, marked by its extensive scrutiny from
both scientific  peers and the  public, Tepper et al. to
successfully defused this problem. Collaborative research
by NHEERL and other ORD scientists characterized the
chemistry and microbial emissions from three problem
carpets. Exposure of mice following a carefully controlled
experimental paradigm identical to that reported in the
press did not result in any significant adverse effects.

Increased asthma morbidity and mortality is a problem
that many scientists believe to be associated  in part with
exposure of allergic individuals to house dust mites
and/or other characteristics of indoor environments. To
study this problem, NHEERL scientists have developed
an animal model for asthma. During FY95, Gilmour et al.
(in press) report that co-exposure of rats to house dust
mites  and NO2, another common indoor pollutant,
enhances  asthmatic responses, whereas exposure to
NO2 by itself does not trigger an asthmatic attack. While
the issue of asthma morbidity and  mortality is far from
resolved, the study indicates that interactions between
common indoor pollutants may produce  unexpectedly
severe adverse effects. This study also paved a new path
of scientific inquiry into mixture toxicity  by evaluating
mixtures of biocontaminants with organic vapors.
 Table 5. Understanding Health Effects of Indoor
 Pollutants	
  •   Understand the relationship between biocontaminants
     and organic vapors and associated signs and
     symptoms.
  •   Develop appropriate models and measurement tools
     for symptom-based conditions.
  *   Develop strategies to study pollutant mixtures.
  •   Pevise approaches to identify susceptible pOftHtatej^gv;
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      Global Change
Human  activities  are increasing the levels of carbon
dioxide  and other gases in the atmosphere. Scientists
agree that these changes will lead to changes in climate-
driven conditions, such as temperature and sea level, and
decreases in stratospheric ozone. ORD must determine
the ecological and human health impacts of these changes
to inform the policy-making process. NHEERL research
is evaluating the potential  ecological impact of climate
change and the potential health and ecological impact of
stratospheric ozone depletion.

Climate Change	
Rising temperatures and rising sea level will likely shift the
composition and geographic distribution of ecosystems,
but the extent,  rate, and interrelationships of these
effects are all unknown. NHEERL research is designed to
answer the three questions presented in Table 6. Key
Questions Related to Climate Change.

Indicators
During  FY95, we reported  on selected fish  species
(Rivulus armoratus) distributions as a potential biological
indicator  of  global  climate  change  to  mangrove
ecosystems (e.g., Taylor et al.).

Effects
Redistribution of fish species may be a major impact of
climate  change. In FY95, we reported our evaluation of
the potential effects of climate change on the distribution
of 57 species of freshwater fishes. The results indicated


 Table 6. Key Questions Related to Climate Change
  •  What can be used as ecological indicators of global
     change to help identify early warning signs that
     climate-related damage to ecosystems may be
     occurring?
  •  What are the long term ecological effects of global
     change likely to be?
  •  How do ecosystems interact with atmospheric CO2 to
     change climate?
that temperature shifts as predicted by a doubling of the
atmospheric carbon dioxide concentration would result
in a 50% reduction in the habitat for cold and cool water
fishes throughout the existing range of these species
(Eaton et al.; Eaton and Scheller).

Modulators
Level of atmospheric CO2 is a major driving force in
global climate change. Many interactive processes affect
the  relationship  between atmospheric  CO2,  global
change, and ecosystem vitality and productivity. NHEERL
is studying the dynamics of these processes, and during
FY95 we reported, as one of the major accomplishments
of the entire U.S. Global Change Research Program, that
net loss of carbon from the terrestrial biosphere may be
close to zero. Therefore, the carbon losses due to
deforestation  must  be  offset by  carbon  accretion
elsewhere in the terrestrial  biosphere (Bender et al.;
Keeling, in press; Keeling and Peng, in press)

Stratospheric Ozone Depletion	
Stratospheric ozone depletion increases UV-B radiation
at the earth's surface. Increased UV-B  is known to
increase  risks of skin cancer and  cataracts in humans.
During FY95,  NHEERL conducted research onsseveral
potential impacts, identified  in  Table  6.  Research on
Stratospheric Ozone Depletion, that are associated with
increased UV-B .

NHEERL research to date has shown that  UV-B  can
indeed suppress human  immune function. NHEERL's
FY95 research begins to  answer the question of what
would be the health impact of such suppression? Three
key questions which must be answered are I) what is the
impact of immune suppression on various  classes of
infections (viral, bacterial, fungal, and parasitic), 2) what
is the window of susceptibility (temporal  relationship)
between  exposure  to  UV-B and  altered immune
function,  and  3)  can  UV-B  affect  hypersensitivity
responses (e.g., allergy/asthma). Selgrade et al. reported
on  progress  and identified  the key problems and
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                                                                               NHEERL FY95 ANNUAL REPORT
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opportunities  for  extrapolating  between animal and
human studies on these issues.

The ozone hole in southern Chile presents a possible
opportunity to study the health effects of increased
ultraviolet exposure. Local reports had suggested that
there may be an effect on the eyes of animals. During
FY95, we reported (Schein et al.,) that it is possible to
perform  standardized   ocular,  dermatologic,  and
immunologic testing  in the  field in  southern Chile.
Despite lay reports of blind sheep, we found no evidence
of short-term  health effects produced by transient
fluctuations in ultraviolet exposure.

During  FY95,  NHEERL scientists resolved a  critical
question about the effects of enhanced UV-B radiation on
rice, the world's most important crop species (Olszyk et
al., Olszyk). Previous studies had shown that UV-B has
significant effects on rice using exposures in greenhouses
and  growth chambers.  However, NHEERL scientists
found no consistent effect under field conditions. The
plants may be less susceptible to UV-B in the field due to
higher UV-A to UV-B ratios that stimulate cell repair.
Consequently, increased UV-B does not appear to pose
a major risk to rice production.

 Table 7. Research on Stratospheric Ozone Depletion
  NHEERL reported on the following suspected effects of
  increased UV-B radiation:
       )
  •  Suppressed immune function in humans
  •  Damage to marine phytoplankton
  •  Reduced rice production
  *  Increased toxicity of certain classes of chemicals
Oceanic phytoplankton are at the base of the oceanic
food  chain. They are at particular risk  from  UV-B
exposure, because they inhabit the surface zones that are
most exposed to UV-B radiation. During FY95, reports
by NHEERL scientists clarified some of the relationships
between exposure to UV-B and marine phytoplankton.
For example, Vassiliev et al. demonstrated that even
100% increases in winter-time UV-B may not adversely
affect the light harvesting efficiency and phytoplankton
production  in productive well-mixed coastal systems, but
even ambient UV-B  levels may inhibit light harvesting
efficiency and phytoplankton production in clear waters
typical of the open  sea.  To  assess maximum  UV-B
impacts under field conditions, shipboard experiments
were conducted using Antarctic phytoplankton during
the period of the ozone hole (Sigleo and Neale, Sikorski
et al.). We found that increased UV-B alters pigment
composition, as expected from laboratory observations.
However, because the effect is mitigated by cloud cover
and mixing of the phytoplankton in the water column,
direct application of lab dose-responses to the Antarctic
may overestimate the actual  effect.

During  FY95, we  reported  that the toxicity of some
aromatic hydrocarbons can  be increased by several
orders of magnitude in the presence of sunlight (Ankley
et al.; Moll et al.). Ultraviolet light activates some of these
compounds such that toxicity increases directly with the
increase in intensity and energy of the light. QSAR studies
have  allowed us to  predict the relationship between
structure of the  chemical and  the  extent to  which
sunlight will increase  its toxicity (Mekenyan et al., Veith
et al.).
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NHEERL FY95 ANNUAL REPORT
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            Conclusions
NHEERL is charged with conducting air research to
support a wide range of topics of concern to the
nation, including criteria pollutants, toxic air pollutants,
indoor air quality, and global climate change. To meet
this charge successfully requires high quality research
over an exceptionally wide range of scientific disciplines
and an understanding of key regulatory and policy
issues. The accomplishments of NHEERL scientists
during FY95 have provided important contributions to
EPA's mission of protecting air quality and the
environment.
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                                                                         NHEERL FY95 ANNUAL REPORT
                                                                      MULTIMEDIA RESEARCH PROGRAM
Introduction
     NHEERL's  Multimedia  Research
     Program focuses on addressing a
key question that is common to the use
of risk  assessment by  all  regulatory
programs:   How   can   we   reduce
uncertainty in the extrapolations used in
risk assessment?

The risk assessment process relies upon
scientific data on the effects of contami-
nants on human and ecological health,
and  models  that  extrapolate  from
existing data to estimate effects where
data are  lacking. Risk assessment-related
research strives to fill data gaps and build
models  and methods  for  information
collection,  interpretation,  and extra-
polation. Ultimately, research informa-
tion  is  evaluated  and  used in  risk
assessments   to   support  National
Environmental  Goals  such  as  safe
drinking water,  safe indoor environ-
ments, clean air, safe food, and healthy
sustainable ecosystems.
NHEERL's  emphasis  on   issues  of
multimedia importance complements its
regulatory program-specific  research
activities.  Decisions on  multimedia
program organization and the nature,
direction, and priorities of the research
reflect  recommendations of the EPA
Science Advisory Board, the National
Academy  of   Sciences,  the  U.S.
Congress's Office of Technology Assess-
ment, the Committee on Environment
and  Natural  Resources, the  White
House Office of Science and Technology
Policy, and the EPA program offices.

The  Multimedia Research Program is
separated into health and  ecological risk
assessment components.  In each of  the
following sections, the  key health or
ecological   research  questions   are
identified,  and  examples of research
published in FY95 that addresses these
questions are summarized.
              \\l//
        Multi-

        media

 Research

   Program

     The US Environmental
  Protection Agency (EPA) is
responsible for implementing
  the nation's environmental
laws to protect human health
     and the environment.
        Decision-making to
    implement these laws is
 supported by the process of
      risk assessment The
    objective of the National
  Health and Environmental
Effects Research Laboratory's
      (NHEERL) Multimedia
     Research Program is to
  improve the scientific basis
for health and ecological risk
             assessment.
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 MULTIMEDIA RESEARCH PROGRAM
FY 1995 Accomplishments
Dl
       Human Wea/fft
Health  risk assessment,  as  defined by  the National
Research Council in  1983, has four steps: hazard identi-
fication, dose-response assessment, exposure assess-
ment,  and risk characterization.  The Multimedia Re-
search Program emphasizes  the uncertainties affecting
dose-response assessment. Some of the program's re-
search addresses  hazard identification questions, but
most NHEERL work to improve hazard identification is
conducted  by  the  Toxics  and  Pesticides  Research
Program.

Quantitative   risk  assessment  invariably  involves
extrapolation from one set of conditions to another to
estimate risks  to human  health. In  the dose-response
assessment  step  of  risk   assessment,  quantitative
extrapolations  are used to estimate the probability of
adverse effects in exposed humans. The key question is:
How  can  we   reduce  uncertainties in  the following
extrapolations?

•  High to low  dose
•  Interspecies (e.g., laboratory rodents to humans)
•  Intraspecies  (across the heterogeneous human
   population)
•  Inter-route of exposure (e.g., inhalation versus
   ingestion)
•  Across time (e.g., subchronic to chronic exposure
   durations)
To address this question, the multimedia human  health
research program has established a coordinated Research
to Improve Health Risk Assessments (RIHRA) Program,
that incorporates the three  components identified  in
Table 8. Research to Improve Health Risk Assessments Program.

The benefits of the RIHRA Program  are that it increases
scientific knowledge of risk assessment parameters and
provides insight for the application of risk assessment
methods to critical human health issues, as illustrated in
Table 9. RIHRA Program Benefits.
  Table 8. Research to Improve Health Risk
  Assessments Program	
  •   Development of quantitative models to estimate
      target tissue dose (e.g., development of physiologically
      based pharmacokinetic (PB-PK) models)
  *   Development of quantitative models to estimate
      target tissue response as a function of target dose
      (e.g., development of biologically based dose-response
      (BBDR) models)
  »   Development of improved quantitative models to
      utilize existing data better (e.g., development of the
      benchmark dose (BMD) approach).
  Table 9. RIHRA Program Benefits
      PB-PK models enable more confident extrapolation
      from results of high-dose studies in animals to predict
      consequences of low-level exposure in humans. PB-PK
      models can simultaneously address issues associated
      with high-to-low dose, species-to-species, and route-
      to-route extrapolations, and provide the time course
      of toxicant dose at target tissues.            f
      BBDR models provide a key resource for
      understanding the likelihood of a toxic response in
      exposed individuals or populations. The/ are used
      with PB-PK models to provide a sound scientific
      estimate of tissue response including toxicity to
      quantitative doses of toxicants. During FY9S, NHEERL
      supported the development of BBDR models for
      developmental toxicity, cancer, neurotoxicity, and
      pulmonary toxicity.
      Development and evaluation of a BMD approach to
      improve noncancer risk assessment has been well
      received by scientific peer groups as a replacement for
      the traditional No Observed Adverse Effect Level
      (NOAEL) technique. EPA is approaching the
      development of a risk assessment guideline to
      incorporate the implementation of BMD.
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                                                     BBDR Models
Physiologically-based pharmacokinetic (PB-PK) models
represent a  mathematical  method to  describe  the
pharmacokinetics (absorption, distribution, metabolism,
and elimination) of chemicals in animals and humans. PB-
PK models are appealing because they can simultaneously
address issues associated with high-to-low dose, species-
to-species,  and  route-to-route  extrapolations,  and
provide the time course of toxicant dose at target tissues.

Specific FY95 accomplishments of NHEERL's Multimedia
Research  Program  address environmentally  relevant
chemical exposures concurrent with development of
generic models for broader application. For example, a
study using O18 provided estimates of pulmonary ozone
dose in humans and animals. Quantitatively, this study
demonstrated that  humans  received a  higher (about
fourfold) dose to pulmonary tissues at a given external
concentration than did rats, largely due to differences in
exercise levels and associated breathing  rates. From a
risk assessment perspective, this study demonstrated the
quantitative relevance of studies in rats to human risk
estimation. Such  information can be used to  adjust
pulmonary dose levels quantitatively for gases of similar
reactivity in the majority of cases where human data are
not available (e.g., phosgene). In addition, these results
demonstrate the importance of exercise  and breathing
patterns in interspecies extrapolation.
Other FY95  accomplishments address PB-PK model
development and application focused on route-to-route
extrapolation for phenol and carbon tetrachloride, and
on the metabolism of methyl mercury in humans. Each of
these chemicals,  and  the issue of  data  use  from
alternative routes of exposure, is important to one or
more of the regulatory programs (e.g., Air, Superfund).
Coupled  with  sensitivity  analyses  of PB-PK model
parameters, which provide insights on study design and
identify the most  critical model parameters, chemical-
specific data support generic PB-PK model development
and interpretation. The resulting advances in target dose
estimation will better enable the use of animal studies to
extrapolate to humans.
Research to improve the scientific basis for health risk
assessment  has  focused on developing  quantitative
knowledge of the cascade of events linking exposure to
disease. The processes through which  toxicants are
distributed from sites of exposure to target tissues and
the mechanisms by which  toxic responses occur are
uncertain, yet central to understanding the likelihood of
a toxic response in exposed individuals or populations.
Together, PB-PK and biologically based dose-response
(BBDR) models are useful in that they support iterative
laboratory data  collection and  quantitative modeling,
ultimately  leading to  a  better  scientific basis for
quantitative dose-response estimation.

The Multimedia  Research Program's FY95 accomplish-
ments related to development of BBDR dose-response
models  began   several years  ago with  theoretical
considerations regarding the development of  BBDR
models, definition of a general framework for modeling
approaches, selection of agents for experimental work,
and,  in  an iterative  fashion  with  data  collection,
development  of a  mathematical  framework that
describes the underlying biological processes.

These efforts involved  experimental work on priority
chemicals, including persistent substances  such as dioxin
and dioxin-like compounds, wherein exposure to these
chemicals was found to alter both male  and female
reproductive function in offspring. These results provide
important  information  for  both the reassessment of
dioxin by the Agency and for future BBDR modeling.

Research  on  the reproductive  effects  of  another
persistent chemical, DDE, resulted in development of a
hypothetical model of a mechanism  by which such
toxicity  occurs. Studies of carcinogenesis provide data
needed  to estimate critical  model parameters  in the
Moolgavkar-Venson-Knudson   (MVK)   model   of
carcinogenesis and support development of a biological
model for the drinking water disinfection by-products
dichloroacetic acid and trichloroacetic acid. Other studies
of mechanisms of toxicity and/or repair include research
on  the hazardous  air pollutant phosgene and  the
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                                                                                                      19

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NHEERL FY95 ANNUAL REPORT
 MULTIMEDIA RESEARCH PROGRAM
fungicide vinclozolin. The research efforts for these
chemicals are at various stages, but the common goal is
to develop an understanding of the mechanisms that lead
to toxicity  and thereby  to improve the  basis  for
quantitative modeling at environmental levels.

As an expanded example of the type of efforts underway
on these agents, work on the model compound 5-FU
began with experimental  efforts to link the postulated
mechanism   of  action,   inhibition   of   thymidylate
synthetase, with alterations in the rate of DMA synthesis,
slowing of the cell cycle, and growth  retardation that
would be related to the development of malformations.
Data published in  FY95  indicate that one postulated
model  of the events leading to malformations, fetal
anemia, is  in fact  not likely involved in  the primary
cascade of events.  This modeling, based on hypothesis
generation and testing, has allowed first-hand knowledge
of the quality and quantity  of information needed to
construct  a  mechanistically  based  model.  It  has
demonstrated the need for careful evaluation of multiple
molecular, cellular, tissue, and organism responses in the
same or similar studies to tie together the progression of
events linking exposure to disease. It also demonstrates
the complexity and time  course of this type of model
development and underscores the difficulty the Agency
may face in replacing default risk assessment approaches
with chemical-specific biological models.

The ultimate impact of these efforts on risk assessment
for a few specific chemicals will not be realized for some
time but  certainly will  form  the  foundation  for
development of BBDR models for  other chemicals.
These  efforts also  enhance EPA's science base for the
improvement of  risk assessment  and  more firmly
establish EPA's leadership in the field of science-based
risk assessment modeling.
The development of mechanistic models, as described
above,  is  a  long-term  goal.  In  the  near-term,
improvements  to  existing  default  risk  assessment
procedures can result in better use of existing data and
more confident dose-response modeling. For the last
several years, there has been strong encouragement by
the Science Advisory Board and others for the Agency to
develop and evaluate the benchmark dose approach. In
the benchmark dose approach, the concept of NOAEL,
traditionally  used in  noncancer risk assessment, is
replaced by a  benchmark dose (BMD),  determined
through dose-response modeling.

Critical studies in support of BMD approach evaluation
were published in  FY95.  In these publications, the
application of the BMD approach to several hundred sets
of developmental toxicity  data was  reported, with an
evaluation of the consequences of selecting  several
alternative benchmarks and model forms. This work was
cited in several conferences and workshops (e.g., Society
for Risk Analysis, International  Life Sciences Institute
workshop) as  essential  and  central  to  confident
incorporation of this method into the risk assessment
procedures used by EPA and others. The application of
this work  has  been immediate  and  substantial,
demonstrating    EPA    leadership   in   advancing
improvements in health risk assessment, and the Agency
is   now  approaching  risk  assessment  guideline
implementation of this approach.
 20
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                                                                                       NHEERL FY95 ANNUAL REPORT
                                                                                   MULTIMEDIA RESEARCH PROGRAM
         Ecological Risk Assessment
Ecological systems support the quality of human life and
represent an  essential resource to  be maintained or
restored.   Through   a  multimedia  ecological   risk
assessment framework (illustrated  in Table  10. EPA's
Multimedia Ecological Risk Assessment Framework),  NHEERL
manages its research activities to understand,  maintain,
and restore the condition, integrity, and sustainability of
ecosystems.

 Table 10.  EPA's Multimedia Ecological R/sk Assessment
 Framework

  Organizes research activities and supports environmental
  management decision-making. The framework
  encompasses research on

  •   The effects of stressors on ecological systems
  *   The multipathway exposure of key species and systems to
      anthropogenic stressors
  •   The assessment of ecological condition and change
  *   The development and evaluation of resource iBonagwnef** and ,
      mitigation options
Ecological degradation may be overt, as demonstrated by
declines of essential commercial fisheries; more subtle, as
suggested  by  declines  in  populations  of migrating
songbirds; or not readily recognized when long-term
habitat   degradation   results   in   shifts   in  species
composition  and  reduced  biodiversity.  Change  in
ecological systems may result from effects of multiple
stressors  (e.g.,  pesticide  exposures,  stream  flow
dynamics) across multiple scales (e.g., watershed sites,
ecoregions)   and  pathways  (e.g.,  air,  water). The
mechanisms  and  consequences  of  changes  in the
biological, chemical, and physical attributes of ecosystems
are  not  well  understood  and  represent  significant
challenges   to   the   research   and   environmental
management communities.

Research on the effects component of the multimedia
ecological risk assessment framework is conducted by
NHEERL. Specific  FY95 NHEERL  accomplishments
address six  key questions, identified  in  Table  II. Key
Questions of NHEERL's Ecological Risk Assessment Research.

NHEERL research published in FY95 will lead to more
effective  and scientifically credible assessment of our
nation's ecological resources. Assessment of ecosystem
condition traditionally focuses on types or categories of
ecological resources, e.g., freshwater systems such as
lakes and streams, terrestrial resources such as forests
and grasslands, and marine systems such as coastal zone
ecosystems. Scientists at WED are evaluating the natural
variability of biological communities in lakes and streams.
Working with universities and State and Federal agencies
across  the country, WED scientists  have  found that
  Table 11. Key Questions of NHEERL's Ecological Rjsk Assessment Research
      What is the condition of the ecosystems that comprise our natural biological resources? Research to address this question focuses on
      development of indicators of ecological condition to identify affected or dysfunctional systems across a range of spatial and temporal scales.
      What are the sources and stressors that affect ecological resources? Research to address this question focuses on developing methods to
      identify and characterize sources and stressors and the means to measure ecological exposure to stressors.
      What are the cause and effect associations between stressors and ecological response? Research to address this question focuses on
      understanding cause/effect mechanisms and development of predictive models.
      How rapidly is the condition of ecological systems changing? To distinguish normal fluctuation in condition from longer-term trends in
      ecological degradation, the research to address this question focuses on development of distributed and intensive networks of study sites.
      How can ecological condition be maintained, or mitigated when degraded? Research to address this question focuses on application of models
      and methods to develop risk management options and predict the consequences of action.
      Have ecological conditions improved fit response to management acaons*;Rere«xh to address this question focuses on identifying critical
      indices to evaluate effectiveness of control strategies.      ,    • ".''"• '^V, ' ,_
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 NHEERL FY95 ANNUAL REPORT
 MULTIMEDIA RESEARCH PROGRAM
biological measurements, while frequently more variable
than chemical or physical measurements, are sufficiently
robust  to allow  detection  of  trends and  reliable
description of ecological condition. These findings will
translate  into  significant  cost  savings  in  monitoring
programs run by Federal and State governments.

NHEERL  research demonstrated that temporal  and
spatial variability  in ecological  parameters must  be
considered  in  the  design  of  studies of ecological
condition.  Studies published by NHEERL  in  FY95
evaluated  variability in the water quality of freshwater
wetlands  as affected by wetlands characteristics  and
surrounding land use. The implications of this variability
on  study  design  were  then assessed. Water quality
characteristics  such  as   turbidity,   and   land   use
characteristics  such  as degree of urbanization, were
found to influence the distribution of fish populations.
Fish populations  are high on the trophic chain and,
therefore, are desirable as potential indicators of aquatic
ecosystem condition. This research will help ensure that
spatial and temporal variables that affect resources are
considered in design of monitoring studies.

NHEERL research in marine systems served as the basis
for the important assessment of the condition of the Gulf
of Mexico estuaries and the Florida Bay. This research
evaluated  potential indicators  of  condition, which
included several scales of analysis, from physicochemical
properties  (e.g.,   dissolved  oxygen,  nutrients)  to
biochemistry  in  fish (e.g.,  vitellogenin, enzymes) to
community parameters (e.g., biodiversity and abundance
of target  species). This evaluation of many potential
indicators  provided the  basis for assessing resource
changes over time.

NHEERL  research improved the basis for evaluating
effects of stressors on ecological resources. Fish and
other aquatic organisms can accumulate stressors such as
dioxin directly from water or through  ingestion of
contaminated  food or   sediment.  An   important
uncertainty in  estimating  effects of  dioxin and similar
(e.g., PCB) contaminants is the relative  amount of
accumulation through each route of exposure.  In FY95,
NHEERL demonstrated a bioconcentration factor from
water  for 2,3,7,8-TCDD of over 500,000,  a number
considerably  higher than previously reported. Other
research demonstrated that exposing fish eggs to dioxin
via either maternal, waterborne, or injection routes of
exposure   results  in  very  similar  dose-response
relationships.  Similar work distinguishing between lower
trophic levels of the food chain,  such as filter-feeders
(Nelson, Bergen, et al., Peters et al.), and higher levels,
such as turtles, seals and dolphins (Lake, Haebler, et al.;
Lake, McKenney, et al.; Kuehl and Haebler) can be  used
to estimate biomagnification factors.

Together, these  NHEERL studies provide improved
estimates  of bioconcentration  and  biomagnification
factors, which are needed for development of models to
estimate toxicant exposures in invertebrates, fish, and
mammalian species. Ultimately, these results support
improved assessment of population and ecosystem risks
from exposure to priority contaminants.

NHEERL  research on the  mechanisms  by which
ecological  effects occur  has   demonstrated   that
laboratory-based  estimates of the toxicity of pollutants
may underpredict ecosystem effects. Ecological effects of
pollutant exposures may result from changes in food web
dynamics. Such dynamics are not well characterized by
the fish toxicity tests commonly used to screen chemicals
for potential impacts of a pollutant on target populations.
NHEERL research has focused on understanding the
mechanisms leading to reduced bluegill growth following
exposure to  diflubenzuron (a pesticide used to control
gypsy  moths). Decreases in rates of fish growth were
associated with reduction  or  elimination  of preferred
insect  prey due to pesticide application, rather than to
direct  toxicity of the pesticide to bluegill. This research
demonstrated that understanding mechanisms by which
ecological effects occur is important to interpreting fish
toxicity test  results,  and also that fish  toxicity tests
provide limited ability to predict indirect ecological
effects.

NHEERL studies published in FY95 illustrated significant
changes in important ecological resources, such as the
22
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                                                                              NHEERL FY95 ANNUAL REPORT
Gulf of Mexico  estuaries and Florida Bay. Based  on
sampling 615 sites, approximately 30% of the estuarine
area in the Gulf of Mexico experienced some degree of
environmental degradation, with about 6% of the area
being  seriously  degraded.  Most of  the degraded
conditions   appear  to   be  related   to   sediment
contamination and toxicity rather than hypoxia. Research
was conducted to determine the change in condition of
submerged aquatic vegetation in  Florida Bay, where it
was found that about 75% of the bottom sediments are
populated by vegetation. In the Chesapeake Bay area,
research quantified significant regional degradation from
hypoxia. These studies illustrate that ecological resources
are changing. Complementary research  is targeted to
determine the causes of degradation in order to help risk
managers develop mitigation efforts.

NHEERL  collaborative  efforts   with   states,  other
government agencies, and the private sector resulted in
additional large-scale, cost-effective analyses of ecological
condition.  Multiyear,  EMAP offshore  demonstration
projects were completed in Lakes Michigan, Superior,
and  Ontario, while monitoring was  initiated in Lake
Michigan wetlands and in a Lake Superior estuary.  An
EMAP study of the  Southern California  Bight was
completed with a ninefold matching contribution from
                                                                           MULTIMEDIA RESEARCH PROGRAM
                                                      the  State. Data collection  and analysis continue from
                                                      these  EMAP studies, with  results from the Northeast
                                                      lakes study revealing a probable major loss in native
                                                      biodiversity.  Almost  no native minnows  were found
                                                      where sportfish have  been  introduced  and  where
                                                      physical modifications to the surrounding landscape are
                                                      the  greatest.   These  studies  contribute  to   our
                                                      understanding of the status and changes  of lakes  and
                                                      streams  potentially affected by stressors  such as acid
                                                      deposition.

                                                      Understanding condition of ecosystems and mechanisms
                                                      by which stressors adversely effect species can lead to
                                                      improved targeting of mitigation efforts. For example,
                                                      NHEERL  research   implicated  a  parasite  in   the
                                                      appearance of withering syndrome in the black abalone
                                                      (Gardener et al.). These results suggest that alternative
                                                      mitigation  strategies  could  be explored  to  alter  the
                                                      progression of abalone destruction. The Northeast Lakes
                                                      assessment research findings also provide insights  on
                                                      mitigation options by suggesting  that lake restoration
                                                      techniques must focus on  human perturbations other
                                                      than direct chemical  contamination.
ft
 >g"^ Conclusion

Concerns about environmental pollution and degradation
of  human  health  and  the environment  result in
tremendous expenditures (over $ 100 billion) to reduce
pollution. Research to improve our ability to estimate the
consequences of environmental pollution is needed to
ensure  adequate  protection  of  health  and  the
environment,  and also to  ensure  that we do  not
misappropriate scarce resources to address insignificant
problems.  Environmental problems are  increasingly
viewed  as  multimedia; e.g., the  research issues  and
questions are of importance to more than one regulatory
program and/or multiple environmental media (e.g., air,
                                                      water) are involved in pollutant or stressor exposure or
                                                      effects. The multimedia  research  efforts highlighted
                                                      above demonstrate that NHEERL  is improving  the
                                                      scientific  basis for risk assessment  and  management
                                                      activities.
ADVANCING KNOWLEDGE FOR A PURPOSE
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                                                               NHEERL FY95 ANNUAL REPORT
                                                               PESTICIDES AND TOXICS RESEARCH PROGRAM
Introduction
"T~he fundamental goal of the NHEERL
  I  Pesticides  and  Toxics  research
program is  to obtain and  interpret
scientific data needed by the Office of
Prevention,   Pesticides,  and   Toxic
Substances   (OPPTS)  and  Regional
Offices  to make  informed  regulatory
decisions.  The   U.S.  Environmental
Protection Agency's (EPA's) mandate to
protect  human   health   and   the
environment  from harmful  effects of
pesticides  and  toxic  substances  is
authorized under two public laws.

• The Federal Insecticide, Fungicide,
  and Rodenticide Act (FIFRA) gives
  EPA the authority to regulate the
  distribution and use of pesticides.
• The Toxic Substances Control Act
  (TSCA) provides the authority to
  regulate the manufacture,
  distribution, use, and disposal of
  industrial chemicals.
These statutes are implemented through
OPPTS and  EPA's  Regional  Offices.
NHEERL provides science and research
support  to   OPPTS  through  the
development  of  standardized   test
guidelines for end-points not previously
evaluated,  revision  to  existing  test
guidelines to reflect scientific advances,
assessment of the quantity and quality of
data  required  for   responsible  risk
management decisions, evaluation of the
need to review past regulatory decisions
in light of new scientific information,
evaluation of opportunities  to  reduce
the number  of animals used in testing,
and consideration of increased reliance
on in vitro screening methods. NHEERL
accomplishes its goal and meets the
science needs of OPPTS and the Regions
by organizing its Pesticides and Toxics
research program around three themes,
described in  Table  12.  Pesticides and
Toxics Research Goals.

The NHEERL Pesticides and  Toxics
research  program is conducted  by  a
scientific  staff of well-trained,  highly
productive, nationally and internationally
recognized experts. Their work, while
directed  toward specific  regulatory
issues, contributes significantly to the
basic body of scientific knowledge. This
is evidenced by the number of instances
in which pesticides and toxic substances
research  reports are shared with the
scientific community through  publication
 Table 12. Pesticides and Toxics Research Goals
  Method      This research includes efforts to develop and validate new methods to identify
  Development  human health and ecological hazards and to improve upon existing methods.

  Model       This research includes efforts to develop predictive models with broad hazard
  Development  identification and data extrapolation application.

  Chemical-     These studies are generally conducted as part of the development or
  Specific Data  validation efforts described above. They result from consultation with the
              regulatory office regarding the selection of agents used for method and model
              development and validation studies.
 Pesticides

 and  Toxics

  Research

   Program

   The objective ofNHEERL's
      Pesticides and Toxics
     Research Program is to
    provide support for pro-
tecting human health and the
 environment from risk posed
   by exposure to pesticides
    and industrial chemicals.
 NHEERL assists the Agency's
 risk assessors and risk man-
  agers through the research
  contributions of a scientific
   staff, including experts in
    ecotoxicology, microbial
  ecology, terrestrial ecology,
  developmental toxicology,
    reproductive toxicology,
 neurotoxicology, and genetic
               toxicology.
ADVANCING KNOWLEDGE FOR A PURPOSE
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NHEERL FY95 ANNUAL REPORT
PESTICIDES AND TOXICS RESEARCH PROGRAM
in widely read scientific journals. In FY95, results of
NHEERL pesticides and toxics research projects were
reported in over 160  peer-reviewed publications. A
selected  sample of these projects is briefly described
                                       below to illustrate the nature of the work and its
                                       contribution to the Agency's regulatory efforts.
FY 1995  Accomplishments
        Methods
One  of  the fundamental  elements  of  the OPPTS
regulatory  program  is  the  compendium  of test
guidelines used to gather lexicological information  on
pesticides and industrial chemicals. These guidelines are
provided to manufacturers to obtain data on both new
and existing chemicals, and for pesticide registration and
reregistration. OPPTS has  historically relied on ORD
scientists to develop, validate, review, and revise test
guidelines.

NHEERL research programs provide the Agency access
to the most recent  scientific advances. Through the
efforts of scientists in the health and ecology divisions,
improvements have been made to various components
 Table 13. Pesticides and Toxics Research
 Accomplishments	
  Method       NHEERL research programs supported the
  Development  development of standardized ecological test
               methods, standardized hazard identification
               methods, and the interpretation of hazard
               identification data.
  Model
  Development
Models developed through NHEERL scientific
research include: physiologically based models
to derive estimates for risk assessment,
ecological risk assessment models to evaluate
environmental stressors, and Quantitative
Structure Activity Models to evaluate new
Industrial chemicals and pesticides.
of the risk assessment process. In the area of hazard
identification, several projects have supported the needs
of OPPTS for standardized ecological  test methods.
The scope of these ranges from review and evaluation
of  general  procedures for  sediments and  organic
chemicals to specific assays for an individual biomarker
of effect. Projects contributing to the development of
hazard identification methods for human health include
studies of  sensory, reproductive, and developmental
processes, as  well as studies of behavior,  including
learning and memory. A related research  focus is the
interpretation  of hazard identification data. Ecological
research in this area included studies of the effects of
variables such  as light, pH, and other aspects of water
chemistry on the outcome of toxicological  evaluations.

Data extrapolation is another critical area in which the
NHEERL  Pesticides  and  Toxics  research  program
provides methods development support to  OPPTS and
the Regions. Ecological projects  of this type include
studies that evaluate both  acute and long-term effects
of chemicals in medaka. Human health studies evaluate
extrapolation  of rat sensory evoked potential data to
humans and the relationship  between developmental
exposures and effects in later stages of life.
              reproductive toxtcity and neurotoxicity for
              pesticides and several health and ecological
              studies on the toxicity of PCBs and dioxins.
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                                                                 NHEERL FY95 ANNUAL REPORT
                                                                 PESTICIDES AND TOXICS RESEARCH PROGRAM
         Models
Several  types  of  models are developed  by NHEERL
scientists to support the requirements of OPPTS and the
Regions.  Physiologically  based   models  of specific
structures, such as the airway and lung, allow prediction
of actual  target dose. This  type of model reduces
uncertainty in the risk assessment process by providing
risk  managers  with  realistic estimates  of dose  and
associated effect.  Large scale models for ecological risk
assessment are also developed and greatly enhance the
ability of OPPTS and Regional assessors to compare the
effects of various stressors on the environment.

The number of new chemicals and pesticides developed
each year exceeds the annual review capacity of OPPTS.
Therefore, it is important to base chemical  screening for
potential toxicity on the best available science, to ensure
that test requirements are appropriate. Extensive toxicity
data are required by FIFRA for all pesticide registrations.
In the case of industrial chemicals,  regulated  under
TSCA, testing requirements can vary.  EPA has 90 days
from the time it is notified of intent to manufacture a
new chemical  and  provided with existing  data to
demonstrate the need for additional toxicity data. The
decision process employed includes evaluation of the
chemical on  the  basis  of its structure  and  physical
properties. Support for the development of Quantitative
Structure Activity Models to assist in this evaluation was
provided by NHEERL health scientists and ecologists in
FY95.

NHEERL scientists also continued to work on the
development  of toxic equivalency factor models that
normalize toxicity across chemicals  in terms of the
toxicity of a  single standard,  allowing  a group of
chemicals to be ranked on the basis of relative risk. This
work helps OPPTS focus its regulatory activities on the
compounds of greatest concern from a risk perspective
and aids in decisions regarding acceptable substitutes for
regulated compounds.
        Chemical-Specific
In some instances, NHEERL scientists provide OPPTS
and the Regional Offices with data on a specific chemical.
Information of this type usually focuses on a compound
of intense  regulatory interest. Often this interest is
generated by controversy regarding the interpretation of
existing data  on  the chemical  in question or the
appropriateness of the test(s) performed.  In  FY95,
NHEERL scientists provided expert advice to OPPTS
scientists concerning the interpretation of reproductive
toxicity and neurotoxicity data submitted to the Agency
in support of pesticide registrations.

In other instances, chemicals are selected for inclusion in
a basic research study because  of their relevance to the
mission of  OPPTS.  For example,  when  NHEERL
scientists  are  designing  a  study  to  evaluate  the
mechanisms underlying a particular effect, they routinely
consider the programmatic relevance of various available
prototype compounds. As a result, the  data generated
are  valuable from both a  specific  and  a general
perspective.

In support of the  Agency's continuing  interest  in the
toxicity of  PCBs   and  dioxins,  NHEERL  scientists
conducted and published the results of several health and
ecology studies of these compounds. Related ecological
work concentrated on the effects of these and other
contaminants in marine species.
ADVANCING KNOWLEDGE FOR A PURPOSE
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 NHEERL FY95 ANNUAL REPORT
PESTICIDES AND TOXICS RESEARCH PROGRAM
        Conclusion
The NHEERL Pesticides and Toxics Research Program
provides support to OPPTS and the Regional Offices
primarily  through   development,   validation,  and
refinement of health and ecology test methods; the
development and validation of predictive health and
ecology models; and the development and interpretation
of data on the human health  and ecological effects of
specific chemicals of intense interest. Applications of this
work include hazard identification, risk assessment, and
screening to determine relative risk. Protocols developed
within this program that become OPPTS test guidelines
are used to guide data collection by manufacturers of
pesticides and industrial chemicals. Thus,  a relatively
small investment results in the generation of a  large
volume of regulatory input.
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                                                                             NHEERL FY95 ANNUAL REPORT
                                                                               WASTE RESEARCH PROGRAM
Introduction
     NHEERL's waste research priorities
     were established to  address the
uncertainties of risk assessment (effects,
exposure, assessment, risk reduction)
and the ability of  research to reduce
these uncertainties or to  reduce the
risks themselves. The Waste Research
Program  supports the three  major
public laws administered by the Office of
Solid Waste and Emergency Response
(OSWER).  ORD  and  NHEERL have
responded  to   the   following  legal
mandates by providing risk assessment
research,   technical    support,   and
technology development to  OSWER and
the Regional Offices.

• The Superfund Amendments and
  Reauthorization Act of 1986
  strengthened the Nation's program
  to mitigate the health and
  environmental hazards posed by
  uncontrolled hazardous waste
  dumps and contaminated plant sites.
  It seeks permanent remedies at
  waste sites and improved
  assessments of the  potential threats
  to human health  posed by each site.


 Table  14. Waste Research FY95 Goals
                         • The Oil Pollution Act of 1990
                           expanded oil spill prevention
                           activities and established a new
                           federal authority to direct responses
                           to spills. It improved preparedness
                           and response capabilities, placed
                           financial responsibility for damages
                           from spills, and established an
                           expanded oil pollution research and
                           development program.
                         • The Resource Conservation and
                           Recovery Act of 1976, as revised by
                           the Hazardous and Solid Waste
                           Amendments of 1984, provided
                           legislation for a national program to
                           protect human health and the
                           environment from the risks of
                           improper management of hazardous
                           and solid wastes.

                         The Waste Research Program goals for
                         evaluating these three federal laws are
                         identified in Table 14. Waste Research
                         Goals.  Research efforts conducted by
                         the program are concentrated among
                         three    groups    of    applications:
                         bioremediation,     improved     risk
                         assessment, and toxicity evaluation of
                         agents found at waste sites.
  Superfund
  Oil
  Spills
  Hazardous
  Waste
To provide guidance on how to evaluate the impact of an uncontrolled waste
site on human health and on the ecosystem. This goal is achieved by
developing improved methodologies, models, and chemical-specific data to
assess potential risks to human health and to the ecosystem.)

To assist in providing an effects-based evaluation of the risk management
options appropriate for remediating spilled oil based on health and ecological
risk assessment. Focus is on bioremediation of oil-contaminated shorelines
and the use of chemical counter-measures.

To provide the scientific and technical information needed by OSWER to
develop and Implement hazardous waste criteria and standards for
        Waste

 Research

   Program

The objective of the National
  Health and Environmental
Effects Research Laboratory's
   (NHEERL) Waste Research
       Program is to reduce
     uncertainties in the risk
  analyses used for environ-
       mental management
  decisions on wastes, waste
       sites, or oil spills. The
   Program seeks to balance
  requirements for vigorous
longer-term effects research
      needed to understand
    emerging environmental
     problems and the more
      immediate short-term
   research needs of the U.S.
   Environmental Protection
Agency's (EPA) Program and
          Regional Offices.
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NHEERL FY95 ANNUAL REPORT
WASTE RESEARCH PROGRAM
FY 1995 Accomplishments
        Bioremediation
The bioremediation program determines the health and
ecological impacts of chemicals and microorganisms and
the impacts from their treatment  residuals. In  FY95
NHEERL  ecologists  completed  numerous  studies
designed to enhance bioremediation as an option for a
toxic chemical environmental cleanup. The focus of the
bioremediation program is identified in Table 15. Focus of
Bioremediation Research.

Protocols, to be used by  the  Agency  in  selecting
remediation options, are being developed and evaluated
for applicability in the laboratory and in the field. In order
to support  protocol  selection,  microbial  metabolic
pathways were characterized for several organisms and
chemical agents  including  fluorene  (Grifoll  et  al.),
halobenzoates (Selifonov et al.), creosote  polycyclic
aromatic  hydrocarbons  (Chapman   et   al.),   and
naphthalene (Eaton). NHEERL completed protocols to
test the effectiveness of oil spill bioremediation products
and continues with the development and/or revision of
protocols for evaluating chemical countermeasures.
 Table IS. Focus of Bioremediation Research	
  •  Develop and test protocols to apply bioremediation
     for toxic chemical environmental and oil spill cleanups
  •  Evaluate the effectiveness of commercial
     bioremediation agents on open water, beach, and
     marsh systems.
  *  Evaluate the toxicity of combinations of oil spill
     pollutants and dispersants.
Research is continuing to focus on the influence  of
environmental parameters on bacterial transformations.
Test systems and protocols  are being developed and
evaluated to examine the efficacy and  environmental
safety of commercial  bioremediation agents (CBAs) on
estuarine organisms in open  water, beach, and marsh
systems (Middaugh and Whiting). To date, eight CBAs
have been tested for efficacy and six for toxicity in open
water, two for efficacy in beach, and two for toxicity in
marsh microcosms, using the new protocols.

The toxicity of pollutants from oil spills in combination
with dispersants is also being evaluated. The surfactant
Triton   X-100  was  shown  to  enhance  microbial
degradation of polycyclic aromatic hydrocarbons (PAH).
However, when fish embryos were exposed to the
water-soluble fraction of No. 2 fuel oil and two different
dispersants, toxicity  was increased (Middaugh  and
Whiting).

Several studies were published  on  attempts to test
whether the metabolism  of mercury  by genetically
engineered  microorganisms  could  be  exploited  in
environmental bioremediation (Nazaret et al., Saouter et
al. "Development and Field Validation,"  Saouter et al.
"Evaluation of Ionic Mercury," Selifonova and Barkay).
Based on this research, it appears that the best use of
such organisms would be in pollution prevention (e.g., in
sewage bioreactors) where the microbes are contained.

In  other work,  a microcosm consisting  of  water,
sediment, and air components  was used to simulate
mercury geochemical  cycling in a mercury-contaminated
stream-pond system. This microcosm could be used to
test remedial treatments aimed at decreasing the amount
of mercury that is available for accumulation by biota
(Saouter et al. "Development and Field Validation").
 30
               ADVANCING KNOWLEDGE FOR A PURPOSE

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                                                                               NHEERL FY95 ANNUAL REPORT
                                                                                 WASTE RESEARCH PROGRAM

        /mprovef/ jj/s|f Assessment at Waste Sites
Detailed and reliable databases are essential for assessing
and ranking ecological effects of waste chemicals to
aquatic life, wildlife, and plants. During FY95, NHEERL
released through the Internet an ecotoxicology database
(ECOTOX) and predictive quantitative structure-activity
relationship models (ASTER) to EPA, federal, and state
agencies for use in the assessment of ecological risks of
chemicals in wastes and  at  waste sites (Bradbury
"Quantitative structure,"  Bradbury et  al.,  Bradbury
"Ecological risk  assessment").

NHEERL scientists tested the additivity assumption used
to assess risks from mixtures of chemicals at waste sites.
Studies have shown that chemicals with similar modes of
action usually conform  to this assumption. NHEERL
ecotoxicologists  developed  a  joint toxic  response
procedure to define the primary mode of action for
diverse industrial organic chemicals (Broderius et al.).
Also,  NHEERL  health  scientists published  a three-
chemical (diethylhexylphthalate, trichloroethylene, hepta-
chlor)  mixture study  on maternal and developmental
toxicity using five doses in a full factorial design (Narotsky
et al.). The three chemicals are known developmental
toxicants and  occur frequently together at Superfund
sites.  Individual dose-response data were reported for
the same chemicals in a companion paper (Narotsky and
Kavleck) that  also addressed the neurotoxicity of the
agents.
          Toxicity Evaluation of Agents Frequently Found at Waste
An extremely important category of hazardous wastes is
represented by the toxic bioaccumulating chemicals.
These chemicals  must be carefully assessed for their
long-term and cumulative effects. A series  of aquatic
full-life cycle and early-life stage toxicity studies were
completed,  with  associated toxicokinetic analyses, in
support of  the  ecological  effects characterization of
2,3,7,8-TCDD (Schmieder et al., Walker et al.). During
FY95, NHEERL's Waste Research Program documented
several  important  research  findings on  toxicity,  as
reported in Table 16. Research Findings from  Toxicity
Evaluations.
Toxicity equivalency factors (TEFs) were developed for
pot/chlorinated biphenyl (PCB) congeners and the
assessment of TCDD and PCB mixtures in the rainbow
trout (Newsted et al., Zabel et al.). Such compounds are
   Table 16. Research Findings from Toxicity
   Evaluations	
   •  Developed Toxicity Equivalency Factors (~TEFs) for
      PCB congeners, TCDD and PCB mixtures, and several
      dioxins, dibenzofurans, and PCBs.
   •  Demonstrated additive interactions for dioxin-like
      chemicals acting through the Ah receptor and
      nonadditive interactions when multiple mechanisms
      are involved.
   «  Developed a model for pdycyclic aromatic
      hydrocarbons to predict the probatiility <
      sediment toxicity on marine and estuarinespie(«
ADVANCING KNOWLEDGE FOR A PURPOSE
                                                 31

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 NHEERL FY95 ANNUAL REPORT
WASTE RESEARCH PROGRAM
very slowly metabolized by the human body and pose
varying  degrees  of  relative  risk.  To gain  a better
understanding of the human response to these chemicals,
the biliary elimination of TCDD in experimental animals
was characterized as an indirect measure of in vivo
metabolism. The effects of age, gender, and  pharma-
cological manipulation on several hepatic enzyme systems
involved in metabolism of TCDD were studied (Dilberto
et al., DeVito et al.). Based upon this work, TEFs were
developed for three dioxins, three dibenzofurans, and six
PCBs to  be used in estimating their toxicity relative to
that of TCDD (Birnbaum and DeVito).

NHEERL health  scientists  showed  that  additive
interactions  occur for dioxin-like  chemicals  acting
through  the arylhydrocarbon (Ah) receptor  and that
nonadditive   interactions   occur   when   multiple
mechanisms of  action are  involved  (Dejongh et al.).
Dioxins or dioxin-like PCBs plus nondioxin-like PCBs can
result in  synergistic production of hepatic porphyries,
altered   pharmacokinetic  behaviors,  and  functional
antagonism of immunotoxicity at relatively high doses
(DeVito  and Birnbaum, Burleson et al.). In studies with
TCDD,  it was  determined  that doses that  result  in
developmental/reproductive effects in rats (permanent
decrease in sperm count, malformations of the external
genitals,  premature   reproductive  senescence,  etc.)
produce concentrations in target tissues of the embryo
that are within a factor of ten of background body levels
in the human population (Abbott et al., DeVito et al.).

Additional  research  focused  on the developmental
neurotoxicity of PCBs: Aroclor 1254 caused persistent
hearing loss (Goldey et al. "Developmental exposure")
and reduction in regulated body temperature (Gordon et
al. "Temperature regulation and metabolism").  These
studies suggest that  fundamental metabolic processes
may be altered  by developmental exposure to dioxin,
with the hypothalamus and thyroid as possible target
sites. NHEERL neurotoxicologists also found that the
ortho-substituted PCBs,  which have little or no Ah
receptor activity (and are thus considered to pose a low
risk relative to dioxin), affect calcium homeostasis with
adverse neurotoxic effects (Kodavanti et al.)
Through the use of knowledge bases and QSAR analysis
(Russom et al.), NHEERL scientists  modeled chemical
substituents  on polycyclic aromatic  hydrocarbons
(PAH)'n order to predict photo-induced acute toxicity
(Veith et al. "A QSAR analysis," Veith et al. "A QSAR
evaluation"). To facilitate improved eco-risk assessments
for the class of PAHs, a model has been developed that
predicts the probability of acute sediment toxicity to
sensitive marine and estuarine species caused by the
combined stresses of  13 PAHs. The study reported an
86.6% correspondence between predicted and observed
toxicity at PAH-contaminated sites.

Key to the conduct of scientifically  defensible risk
assessments is the development of relating exposure to
specific chemicals  to  their induced effects.  NHEERL
health  scientists demonstrated  a mechanistic linkage
between  DNA  adducts  induced   by environmental
polycyclic aromatic hydrocarbons (PAHs), mutations in
oncogenes, and tumor formation, thereby paving the way
for the use of these biomarkers in relating environmental
exposures to induced health effects  (Nesnow  et al.
"Mechanistic linkage," Ross et al., You et al.). In addition-
al investigations, a relationship between adduct formation
and the mutagenicity of trinitrotoluene metabolites was
shown, and it  was demonstrated  that  the pesticide
atrazine potentiates the mutagenicity of dinitrotoluene
(Chadwick et al. " Potential on," George et al.).

In  health research  on  arsenic,  NHEERL  scientists
developed analytic strategies for the characterization of
arsenic metabolites in a variety of  biological  matrices
(Styblo et al. "Identification of methylated metabolites,"
"Mono- and Dimethylation of Arsenic"). This research
will provide needed information on arsenic metabolism
and target  organ  toxicity in  support of health risk
assessment.  In  other  research,  arsenite,   but not
cadmium, was shown to induce ornithine decarboxylase
and heme oxygenase in rat liver. These enzyme inductive
effects  represent potentially important biomarkers in
arsenic carcinogenesis (Brown and Kitchen).
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                                                                     ADVANCING KNOWLEDGE FOR A PURPOSE

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During FY95,   NHEERL scientists  completed  and
published a great deal of research related to technical
support, and technology development. This research has
produced  new  protocols for  bioremediation,  more
accurate information  for the  assessment  of risks to
humans from exposures to mixtures of waste chemicals,
                                                                              NHEERL FY95 ANNUAL REPORT
                                                                               WASTE RESEARCH PROGRAM
detailed and reliable databases on ecological effects of
waste chemicals, and data on the relative risks of the
toxic bioaccumulating chemicals.
ADVANCING KNOWLEDGE FOR A PURPOSE
                                                                                                     33

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Introduction
                                                                          NHEERL FY95 ANNUAL REPORT
                                                                                    WATER PROGRAM
    The   NHEERL   water  program
    performs  research  to  increase
scientific   knowledge  where  major
uncertainties exist. This research pro-
vides critical scientific data, methods,
                             and  models  to  help reduce  major
                             uncertainties  in  environmental  and
                             health risk assessments. These efforts
                             lead to  more scientifically  sound  and
                             cost-effective regulations.
FY 1995  Acomplishments
a
Water Quality
The Clean Water Act authorizes the
EPA to develop regulations and guidance
to restore and maintain the physical,
chemical, and biological integrity of the
nation's  waters. The Office of Water
supports this mandate through programs
designed to minimize the environmental
and human health risks associated with
pollutant   discharges    and   other
environmental disturbances to  fresh,
estuarine, and marine waters.

lntcgmte
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NHEERL FY95 ANNUAL REPORT
WATER PROGRAM
The NHEERL water quality research program is divided
into three interrelated research components:  Aquatic
Ecocriteria,   Contaminated  Sediments,   and  Wetland
Protection.
Aquatic Ecacrfterl*
Broadly  defined,   aquatic  ecocriteria  are  physical,
chemical, and/or biological parameters that are derived
for the protection of aquatic life and wildlife. Types of
criteria  include those described  in Table 18. Types of
Aquatic  Ecocriteria. NHEERL scientists have conducted
extensive research to improve the scientific basis for
these criteria. NHEERL efforts have included research in
the  area of ecosystem diagnostics which assist risk
assessors and  managers in determining the most likely
causes of effects  observed  in  aquatic  systems and in
determining the best approach for watershed protection
(e.g., chemical-specific criteria versus biocriteria).

NHEERL  research  has  also  focused  on   hazard
identification studies or  methods development research
to characterize the toxicity  of  single chemicals  or
mixtures of contaminants in sediments, effluents, and
surface waters.
                               Specific  examples  of  how  NHEERL  research  has
                               advanced knowledge in the development of  aquatic
                               ecocriteria include the following:

                               • Holcombe et al. and Cripe characterized the toxicity
                                 of a number of individual chemicals by describing the
                                 effects these single contaminants cause in different
                                 aquatic species.
                               • Burgess et al. characterized the toxicity of a mixture of
                                 contaminants by reporting the effects of contaminated
                                 industrial and municipal effluents.
                               • NHEERL scientists developed  useful techniques for
                                 predicting acute (Sun, Kai,  et al.) and chronic (Lee,
                                 Gunher, et al.) toxicity of chemical contaminants from
                                 different types of data sets.
                               • NHEERL scientists provided  baseline  information
                                 concerning the influence  of  water temperature,
                                 salinity, and starvation stress on the health of aquatic
                                 organisms  (Cripe,  "Induction   of  maturation";
                                 Behrenfeld, Lee, et al.; Ho, Mitchell, et al.; McKenney
                                 and Celestial).
                               • NHEERL scientists described ecological conditions at
                                 the regional/landscape level and the response of large
                                 scale ecosystems to multiple environmental stresses
                                 (Griffith, Omernik, et al.; Larsen et al.).
  Table 18. Types of Aquatic Ecocriteria
   ECOCRITERIA
   Chemical-specific
DESCRIPTION
Numerical thresholds that, when exceeded, signal degradation of aquatic species condition
Quantitative values or narrative statements that describe the biological condition of aquatic
communities for a particular type of water fcody («.f,, river, estuary, wetlands) or use category (e.g.,
36
                                               ADVANCING KNOWLEDGE FOR A PURPOSE

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                                                                               NHEERL FY95 ANNUAL REPORT
                                                                                         WATER PROGRAM
Ctmtamtnatetl Sediments.
Many toxic chemicals accumulate in the sediments of
coastal, estuarine, and freshwater ecosystems and thus
adversely affect  benthic  biota  and  other  aquatic
communities. Bioaccummulation and biomagnification of
these sediment contaminants  in the food  chain may
ultimately threaten human health and wildlife.

NHEERL research efforts on contaminated sediments are
focused in the three general areas described in Table 19.
Contaminate Sediments Research Areas.

Certain physicochemical processes control the biological
availability  of sediment-associated  contaminants  in
aquatic  systems.  Advancing   knowledge  of  these
processes is key to improving estimates of contaminant
toxicity in sediments. Accordingly, Pesch et al. evaluated
the role  of sulfide in determining the bioavailability of
cadmium and nickel in sediments.
            NHEERL scientists also performed research that resulted
            in advances in the use of predictive bioaccumulation
            methods  (Boese,  Winsor,  et  al.)  and  equilibrium
            partitioning (DiToro, Zarba, et al.; Hoke, Ankley, et al.)
            for establishing more scientifically sound SQC for organic
            contaminants in sediments.

            A need also exists for better models and test systems to
            assess  the  individual   and  aggregate  toxicity  of
            contaminants in sediments. Swartz et al.  developed an
            innovative method to predict the toxicity of a mixture of
            polyaromatic  hydrocarbon  mixtures  in  sediments
            collected in the field.  Burgess and Morrison and Phipps
            et al. explored the use of different species for use in
            sediment toxicity tests.
 Table 19. Contaminated Sediments Research Areas
   RESEARCH AREA
   Support for the development of sediment quality
   criteria (SQC).
   Development of short- and tang-term toxidty
DESCRIPTION
SQC define safe levels of individual chemicals in sediment.
ADVANCING KNOWLEDGE FOR A PURPOSE
                                                                                                      37

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NHEERL FY95 ANNUAL REPORT
WATER PROGRAM
Wetlands Protection
Loss or degradation of U.S. coastal and inland wetlands
in recent decades has been attributed primarily to the
environmental  stresses  that  accompany  population
growth and competing demands on aquatic resources.
          To support sound management decisions designed to
          protect these valuable resources at the local, regional,
          and   national   levels,   NHEERL   researchers  have
          successfully addressed several critical issues. Table 20.
          Wetland Science Issues and Accomplishments presents
          three of these issues.
 Table 20. Wetlands Science Issues and Accomplishments
   ISSUE
ACCOMPLISHMENT
   I.  Characterization of the physical, chemical, and     NHEERL scientists described the effects of physical disturbances on urban
      biological stressors and their effects on           wetland water quality (Detenbeck, numerous articles).
      wetlands.

   2.  Understanding the Interactions of wetlands with    Scientists studying Great lakes coastal wetlands identified important
      other ecosystems within broad geographic       regional and local factors that Influence ecosystem health (Brazner and
      areas, such as ecoregions and watersheds.
                                               Holland et al evaluated patterns and effects of wetlands loss and
38
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                                                                              NHEERL FY95 ANNUAL REPORT
                                                                                         WATER PROGRAM
         Drinking Water
The Safe Drinking Water Act (SDWA)  of 1974, as
amended in  1986,  requires the EPA to identify and
regulate  drinking water contaminants that may pose a
risk to human health. The SDWA also authorizes EPA to
carry out research to ensure that regulatory decisions are
based on sound scientific information.

NHEERL conducts research to reduce uncertainties in
the risk assessment process for priority contaminants in
drinking water. This research has provided

• Improved characterization  of health risks posed by
  drinking water contaminants.
• Support for  development of contaminant or class-
  specific   Maximum   Contaminant  Level   Goals
  (MCLGs)/Maximum Contaminant Levels (MCLs).
Important  long-term research  at NHEERL includes
pharmacokinetic and mechanistic  studies to evaluate
biological processes by which  key  drinking  water
contaminants cause their effects. This information is used
to develop and evaluate biologically based dose-response
models, which facilitate the extrapolation of toxicity data
from animals to humans. These  models represent a
significant   improvement  over   conventional   risk
assessment  approaches, which  generally rely upon a
number  of  default assumptions.  Studies  are  also
conducted in the laboratory, clinic, and field to help
characterize toxic  endpoints of concern (e.g., cancer,
adverse reproductive outcomes, gastrointestinal effects)
and the exposure levels at which these effects occur.

Disinfection By-Products	
Widespread use of chlorine and other disinfectants in
drinking  water has been  highly effective in reducing
devastating  waterborne  disease  outbreaks such as
cholera and typhoid. However, formation of low levels of
disinfection  by-products (DBPs) during the treatment
process has raised questions about the risks of DBPs to
humans. A major objective of the drinking water research
program  is to provide data to characterize the toxicity of
the DBPs that may be of greatest concern from a
regulatory perspective..

NHEERL scientists have provided key insights into the
carcinogenicity  of  dichloroacetic  acid  (a  haloacid)
(Benane; Carter, J., Carter, H., et al.; Ferreira-Gonzalez
et al.,  Richmond  et al.; Snyder  et al.).  Research by
Carter,]., Carter, H., et al. and Snyder et al., has helped
define  critical parameters that are required for the
development of  a biologically based  dose-response
model for dichloroacetic acid.

Gao et  al. discovered a novel metabolic pathway  for
bromodichloromethane (a trihalomethane)  that has
important  implications  for the  development  of a
physiologically based pharmacokinetic model and which
provides insights  into  the relative potencies of the
different members of that class of DBP.

Concern has been raised  over the potential risks of
adverse reproductive outcomes following exposure to
DBPs in drinking  water. Under et al. demonstrated
effects on the male reproductive system of rats exposed
to dibromoacetic acid, suggesting the need for additional
studies to define further the dose-response relationship
for this brominated by-product.

NHEERL  scientists demonstrated  the  utility  of a
quantitative   structure-activity   relationship  (QSAR)
analysis for prioritizing compounds for in vivo study. They
used this approach to estimate the  developmental
toxicity of a series of halogenated acids in vitro.
ADVANCING KNOWLEDGE FOR A PURPOSE
                                                                                                      39

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NHEERL FY9S ANNUAL REPORT
WATER PROGRAM
Arsenic
Aluminum
Among the many naturally  occurring and  man-made
source water contaminants of potential concern, arsenic
is one of the most important from a regulatory and public
health perspective.  Research at NHEERL is addressing
several key scientific issues that affect the risk assessment
for arsenic in drinking water. Publications by Styblo et
al., "Identification of methylated metabolites"; "Mono-
and dimethylation of arsenic"  in FY95 on the metabolism
of arsenic provide important information on the role that
glutathione may play in the methylation and detoxification
of arsenic. These findings represent critical steps toward
a better understanding of the dose-response relationship
for arsenic toxic actions, the relationship of metabolism
to toxicity, and the important factors that can affect the
variable sensitivity of humans to arsenic.
Alum, or aluminum sulfate, is widely used as a coagulant
for removing nonsettleable solids in the water treatment
process. Although the low levels of aluminum in drinking
water are generally considered to be safe, concerns have
been  raised about the possible relationship  between
exposure   to  aluminum  and  the   incidence   of
neurodegenerative diseases such as Alzheimer's disease.
Research  at  NHEERL  on aluminum  is  directed  at
understanding  the possible  mechanisms by  which
aluminum may be  neurotoxic.  Publications by Gilbert
and Shafer, "In Vitro Exposure to Aluminum" and Mundy
et al., "In Vitro Aluminum Inhibition" describe potential
cellular and molecular sites of action, and provide clues
as to the types of effects that aluminum may have on
brain function.
40
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                                                                                NHEERL FY95 ANNUAL REPORT
                                                                                         ECOLOGY DIVISIONS
Overview of NHEERL Ecology Divisions
There are four NHEERL ecology divisions.
Each  division has  a geographic  and  a
scientific focus, as described in  Table 21.
Ecology Divisions Overview.
 Table 21. Ecology Divisions Overview
   DIVISION
  Atlantic
  Ecology
  Division (AED)
LOCATION    RESEARCH Focus
Narragansett,
Rl
   Gulf Ecology
   Division (GED)
Gulf Breeze,
FL
   Mid-Continent
   Ecology
   Division (MiD)
Dutoth, HN
Gross* He, Ml
(field station)
Marine, coastal, and estuarine water quality.
Develop, and evaluate theory, methods, and data to
understand and quantify better the environmental
effects of anthropogenic stressors on the coastal waters
and watersheds of the Atlantic seaboard.
Areas of research specialization include modeling
cumulative effects of multiple anthropogenic stressors
on coastal ecosystems, development of methods for
assessing the ecological effects of contaminated marine
sediments, and geographic-based ecological
assessments for the Atlantic Coast.

Evaluate ecological conditions of gulf coastal wetlands,
bays, estuaries, and coral reefs,
Develop predictive models that consider the impact of
chemical contaminants, biotechnology products,
disease, nutrients, energy development, and global
warming.
The scale of investigation ranges from microorganism to
watershed/landscape, with particular expertise in
microbial ecology.

Develops methods for predicting and assessing the
effects of {joteiting activities on freshwater ecological
resources;
    Ecology

 Divisions


 The NHEERL environmental

 effects research program is

the responsibility of the four

     ecology divisions. The

  accomplishments of these

      divisions reflect their

 transition from an ecology-

    oriented program to an

     environmental effects

  program that supports the

  risk assessment paradigm.

This section provides a brief

   overview of the strategic

   context of this program.
ADVANCING KNOWLEDGE FOR A PURPOSE
                                                                                       41

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 NHEERL FY95 ANNUAL REPORT
 ECOLOGY DIVISIONS
EMAP
In addition to the nine research Divisions,  NHEERL also
directs the Environmental Monitoring and Assessment Program
(EMAP).  EMAP activities cut across the ecology divisions and
include designing a comprehensive environmental research and
monitoring program regarding  the condition of ecological
resources; providing the science that enables Federal and State
monitoring data to be combined and extrapolated among and
within monitoring  networks;  and  promoting  extensive
involvement of other EPA laboratories, other Federal agencies,
Regional   Offices,  States,  and  interested  international
communities  to ensure a well-coordinated and  maximally
leveraged research program.

Research Framework	• -=':  ,-'
As with all research in ORD, ecological research is focused on
the greatest scientific uncertainties in the risk assessment
process.

Ecological research is central to measuring, understanding, and
predicting the effects from chemicals in natural populations in
terrestrial and  aquatic  ecosystems. Each  ecology division
continues to  advance  new  and  improved  methods  for
identification of chemicals that are potentially hazardous to the
important species of coastal and inland ecosystems.
Ecotoxicology
Advances  in clinical risk assessment  methods  have led  to
increased  understanding of toxicity mechanisms and of the
extrapolation of effects among species. These advances have
enabled  the  ecotoxicology  program  (which  requires
extrapolation of test effects to hundreds of important species)
to focus on the development of biological models for chemical
risk assessment. MED will continue the NHEERL emphasis in
ecotoxicology as the other divisions expand their research  on
the effects of other anthropogenic stressors. However, as the
following divisional reports demonstrate, all divisions will have
to take advantage of the advancing body of knowledge and
expertise in ecotoxicology (e.g., effects of toxic chemicals in
studies of cumulative impacts of multiple stressors).

Ecological Risk Assessment
The performance of ecological risk assessment poses many
scientific questions that are not usually found in chemical risk
assessment. Regional/landscape ecology is central to providing
the  answers to  these questions  by  means of measuring,
understanding, and predicting the effects  of  nonchemical
stressors  on natural  populations.  WED,  GED,  and  AED
continue to advance and validate knowledge in these areas as
they address problems of ecosystem scale, and formulate and
characterize environmental risks.

The landscape ecology program is developing methods  to
"take the pulse" of an ecosystem. These methods are designed
to assess  the biodiversity, system  integrity, and  long-term
sustainability of an ecosystem. They  take into account the
importance   of  temporal  variation  in   extrapolating
experimental findings to real life situations and  in predicting
environmental effects on a regional scale.
42
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Important Scientific Issues
                                                                       NHEERL FY95 ANNUAL REPORT
                                                                       ATLANTIC ECOLOGY DIVISION
    The AED mission and research acti-
    vities support interagency research
priorities in:

• Ecosystem dynamics
• Resource use and management
• Ecosystem research
• Coastal and marine environments
AED  scientists  published  34  peer-
reviewed research articles, in FY95, that
directly contribute  to  ORD's primary
responsibility to provide the scientific
foundation  for  our nation's environ-
mental programs.   Some  of  these
research    accomplishments     are
presented in this document with regard
to  how they  address  current and
emerging   environmental  issues  and
support EPA's  goal  of advancing the
science and technology of ecological risk
assessment.
The articles presented in this document
represent only a "moment in  time"
owing to the dynamic nature of the
research in AED and elsewhere. Publi-
cation of these significant accomplish-
ments should provide a useful overview
concerning the direction AED is headed
as they work to advance knowledge in
the areas of:

• Ecosystem Health and Integrity
• Ecological     Significance     and
  Extrapolation Ecology
• Integrated     Ecological     Effects
  Assessment (methods and modeling)
• Biological  Availability,  and  Global
  Change considerations
Refer to Table  22.  AED Issues and
Accomplishments Overview, for a quick
look at some of the major accomplish-
ments of Fiscal Year 1995.
    Atlantic

    Ecology

    Division

The Atlantic Ecology Division
     (AED), Narragansett, RI
 conducts scientific research
to advance knowledge of the
    environmental effects of
  anthropogenic stresses on
     the coastal waters and
  watersheds of the Atlantic
               seaboard.
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NHEERL FY95 ANNUAL REPORT
ATLANTIC ECOLOGY DIVISION
FY 1995 Research Accomplishments
        Ecosystem Health and Integrity
An ecosystem is an intricate combination of organisms
that   interact  with  their  physical  and  chemical
environments, functioning  together as an ecological
unit. The current functional and structural condition
("health" and "integrity") of an ecosystem is the result of
the cumulative  effects of natural and anthropogenic
inputs to the  system. Ecosystem health and integrity
are not currently well-defined attributes of coastal
systems.  In order to better define these attributes,
AED  (along with other divisions) has pursued the
development of biological criteria that may be used to
assess the biological integrity of aquatic communities—a
goal not addressed by the physical and chemical water
quality  assessment  approaches  that  have  been
practiced for decades.

There is a need for  research to enhance the process of
characterizing, understanding, and predicting physical,
chemical, and biological conditions caused by both natural
conditions and anthropogenic inputs.

*• Concerning  physical  conditions,  AED  scientists
  developed  an innovative device for characterizing
  and predicting  the  entrainment  of sediments
  (Abdelrhman et al.).

*• AED scientists  performed research  to  increase
  understanding of nitrogen and phosphorus inputs
  and cycling in Chesapeake Bay and several selected
  tributaries (Boyton et al.).
A  major  focus  of research  in FY95  related  to
characterizing the accumulation of anthropogenic con-
taminants at several trophic levels in the food chain.

*• AED     scientists    quantified     contaminant
  concentrations in two bivalve species (Nelson et al.)
  and investigated histological effects of contaminants
  in another bivalve (Peters et al.). These studies are
  important because they provide a  link  between
  characterizing chemical inputs and understanding
  biological effects  in lower trophic levels of the food
  chain (i.e., water column filter-feeders).

^ AED   scientists   investigated the  uptake   of
  anthropogenic contaminants at a higher trophic level
  in turtles, seals, and dolphins, respectively (Lake et
  al. 1994, Lake et  al. 1995, Kuehl and Haebler). This
  information is important because the accumulation
  of contaminants  in higher  trophic levels provides
  information  that can be  used to  estimate  the
  biomagnification  of contaminants that can  have
  potentially dramatic ecological effects.  In addition,
  examination  of  these higher  trophic  levels may
  provide an indication of ecosystem health because
  they integrate the effects of lower-level impacts.
44
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                                                                                NHEERL FY95 ANNUAL REPORT
                                                                                 ATLANTIC ECOLOGY DIVISION
      Ecological Significance
Research  supporting environmental  regulation  has
evolved from a single-contaminant perspective to one
addressing the ecological risks associated with a variety
of  stressors  at  a number  of levels of biological
organization. This evolution has brought environmental
research into the realm of ecology, and the questions
now being asked are of an ecological nature. Significant
uncertainty  exists concerning the understanding and
interpretation of the effects of environmental stressors
on ecological systems.

As with other  divisions, and their associated research
areas,  extrapolation of findings is  important  in  the
developing field of ecological risk assessment. In AED,
significant attention  is being  paid  to questions  of
extrapolation ecology. AED research accomplishments in
FY95 laid the groundwork for  addressing the issues
surrounding both ecological significance and extrapolation
ecology.

* AED scientists have performed work to increase the
  understanding  and effectiveness  of extrapolation
  ecology (e.g., Suter and Vaughan 1984, Suter et al.
   1985, Walker 1988, Barnthouse 1987, Gaylor et al.
   1992,   and  others).   This   research  lays   the
  groundwork for the extrapolation  research to be
  conducted in ecological significance.  Similarly, a firm
  foundation of theory and experimentation underlies
  the  process ecology  aspects  of  this  research.
  Ecological significance research will advance our
  understanding  in these areas, thereby reducing
  uncertainties currently associated with ecological
  risk assessment.

*• AED scientists evaluated the mechanisms involved in
  contaminant uptake  by  brown  cells  found  in
  commercially harvested hard clams, and evaluated
  the  sensitivities of these  cells to organic  and
  inorganic chemicals (Zaroogian and Anderson 1995,
  Zaroogian and Voyer,  in press).  This research
  advances  knowledge  of the  characterization of
  mechanisms of stressor insult and development of
  indicators of ecological effects.

*• AED scientists  obtained  information  through  an
  analysis of stress protein accumulation in mussels,
  which may help to identify tissue systems that are
  most susceptible to damage  caused by particular
  chemical stressors (Sanders et al.). These  efforts
  support identification of  inexpensive and  rapid
  indicators  of  biological  impact  and  encourage
  additional   ecological   significance  research   to
  continue to improve  the interpretation of such
  indicators within an ecological context.

AED research also supported characterization of effects at
higher  levels  of ecological  organization,  in  order  to
strengthen  our  understanding  of  the   causes  and
significance of these higher level effects.

AED scientists found evidence implicating a prokaryotic
parasite in the symptomatic appearance of withering
syndrome, a  devastating disease in  California's black
abalone, (Gardner et al.). Such species interactions may
play significant roles in exacerbating or mediating the
effects of anthropogenic stressors.

^ AED scientists described some  basic life history
  traits for  the inland silversides,  a species  of fish
  commonly used to evaluate toxicity of marine and
  estuarine waters (Gleason and Bengtson, in  press).
  Using  information from that study, a population
  dynamics model is being developed at AED with the
  goal of understanding the ecological consequences
  of endpoint responses observed  in the standard
  inland silversides toxicity test. This research will lead
  to improved interpretive guidance for a number of
  EPA and state regulatory programs.

^ AED scientists used population models to evaluate
  ecological risks associated with disposal of municipal
  sewage sludge at the 106-Mile Deepwater Dumpsite
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NHEERL FY95 ANNUAL REPORT
ATLANTIC ECOLOGY DIVISION
  (Munns et al., in press). The results of this work
  indicated the potential impacts of sludge disposal to
  be minimal for upper-water column species at the
  site.
By reducing the uncertainties in interpretation and
prediction of ecological effects, research products such
as these will improve EPA's ability to understand the
risks posed  by stressors to coastal  systems  of the
United States.
       Ecological Risk Assessment
The use of a systems approach and an ecological risk
assessment  (ERA) perspective is  not new to the
research  conducted at AED.  The  ocean dumping
research program used both of these, calling it "hazard
assessment."

*• AED scientists have  recently  summarized the
  research which was conducted during the 1980s as
  applied to the disposal of sewage sludge at the
   106-Mile  Ocean  Disposal Site, off the northeast
  coast of the U.S. (Paul et al., in press). The research
  was based on a risk assessment approach, evaluating
  the  likelihood  of potential ecological and human
  health  impacts due to the disposal  of sludge at the
  site. Both exposure and effects assessments were
  conducted using a systems approach to formulate
  the  models for the assessments conducted  with
  information that was available prior to initiation of
  disposal  activities. Numerous field  studies  were
  conducted  subsequently  by  EPA  and  NOAA,
  providing information that was used by Paul et al. (in
  press) to  evaluate the original assessments. Overall
  results confirmed the validity of the approach and
  the assessments to predict impacts from disposal.

There is a need for ecologically relevant information that
can be used by  environmental managers  in making
important environmental decisions.

*  Ecological risks associated with sewage sludge at the
   106-Mile Site were also examined prospectively in a
   case study focusing upon population-level responses
   (Munns  et al., in  press).  The  case study was
  described in terms of the EPA's Framework for
  Ecological Risk Assessment. A conceptual model was
  developed describing the nature of the stressor,
  ecosystems potentially at risk, and ecological effects
  on resident populations. Analysis procedures drew
  upon modeling activities conducted  before actual
  disposal discussed in Paul et al. (in press). Risks to
  the site, associated with the 1988 sludge loading
  rate, were generally low, but increased dramatically
  when  loading was simulated at  two  orders  of
  magnitude above that rate. This research illustrates
  how  ecologically relevant  information  can  be
  generated for use by environmental  managers in
  order to make environmental decisions.

The need for research  on ecological  indicators is  an
important aspect  in developing tools for conducting
assessments. Contaminant-related indicators have been
traditionally  the most  studied  ecological  indicators.
Indicators of past contamination are important to put the
current condition in context and to estimate trends  for
those indicators that  have no historical data base.

* AED scientists examined the  historical input  of
  organic   contaminants  to   an  urban   estuary,
  Narragansett Bay,   by  interpretation  of  the
  sedimentary record (Latimer and Quinn, in press).
  They constructed a mass balance model for the
  system by comparing sedimentary flux estimates
  with  directly measured  inputs  to use  as  an
  interpretive  framework for assessing the current
  inputs.
46
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                                                                                 NHEERL FY95 ANNUAL REPORT
                                                                                 ATLANTIC ECOLOGY DIVISION
Eutrophication  is  a  much  discussed,  broad-scale
environmental  problem  in  estuarine  systems.   An
important aspect of developing conceptual models for
addressing this problem is specifying and quantifying the
causal links in the conceptual model along with input and
output across the system boundaries. Construction and
application of systems models permits identification of
major areas of uncertainties.

* AED scientists  reported on  experimental results
  from  large  marine  enclosures,  addressing  the
  transition between phosphorus limitation of primary
  production in freshwater and nitrogen limitation in
  seawater Oviatt, et al.).
  The work of Boyton et al. assembled and analyzed
  annual input-export budgets for total nitrogen and
  total phosphorus for Chesapeake Bay and three of
  its  tributaries.  The results  indicate that direct
  relationships exist between annual rates of nutrient
  input, water-column and sediment nutrient stocks,
  and nutrient  losses via  burial  in  sediment  and
  denitrification. The identified sources  of major
  uncertainties  were in  estimates of atmospheric
  deposition,    contributions   of   nutrients   via
  groundwater, and sediment rates used to calculate
  nutrient burial rates.
Accurate ecological  risk assessments require that
substances  causing  adverse  ecological impacts  be
correctly identified and that concentration-response
relationships be based on bioavailable concentrations
for organisms in a community.  By using bioavailable
concentrations, ecological impacts can be understood
across sediments and surface waters whose properties
vary spatially and temporally.

Substances that might be causing toxicity in sediments,
in effluents, or in  nonpoint sources entering surface
waters  can be  identified using biologically directed
chemical  fractionation (Toxicity Identification Evalu-
ation, TIEs) procedures, or predicted using equilibrium
partitioning-based  (EqP)   estimates  of  available
concentration coupled  with concentration-response
relationships for organisms. Regulatory needs of EPA
Program  Offices,  Regional  Offices, and states  have
been linked to this  long-standing  research  effort.
Publications  include  both   scientific  papers  and
regulatory documents.

Research to develop and validate  TIE procedures for the
marine environment has been in progress for five years. It
has  resulted in publications  and  technical support
documents that permit application of TIE methodologies
to identify the cause of toxicity associated with sediments,
effluents, and surface waters.

* AED scientists describe the use of TIE procedures
  developed at AED, using marine fish, invertebrates,
  and a plant to identify metals and nonionic organic
  chemicals as the cause of toxicity associated with an
  industrial and  a municipal effluent (Burgess, Ho et
  al.). This study illustrates that marine toxicity tests,
  TIE procedures, and historical data can be combined
  to increase understanding of the ecological risks of
  toxic  effluents   discharged   into  the  marine
  environment.

* One concern in conducting TIEs with effluents that
  enter  marine  systems is that  effluents consist of
  freshwater while receiving waters are saline. Ho et
  al. present data demonstrating that addition of brine
  to effluents to achieve salinities of receiving waters,
  or salinities tolerated by test species, should occur
  after sampling,  with TIE  tests  occurring   soon
  thereafter. Burgess and Morrison describe the utility
  of  marine  clams as organisms  for  testing the
  sublethal  effects  of sediment-associated  contami-
  nants.  The procedures described in this paper are
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 NHEERL FY95 ANNUAL REPORT
ATLANTIC ECOLOGY DIVISION
  part  of the overall  effort to  develop TIE test
  metrologies for contaminated sediments.

Research on the biological availability ofnonionic organic
chemicals and metals in sediments, and the establishment
of acceptable sediment concentrations  for ecological
protection, have been fundamental principal research
components of the  sediment quality criteria (SQC)
program for about ten years. This program has produced
sediment  quality  criteria documents for five nonionic
organic chemicals and a large number of scientific papers
and  technical  support documents  that have been
published by AED and other NHEERL scientists.

*• AED scientists describe the EqP approach as the
  scientific basis  that justifies the derivation of SQC,
  and allows  prediction  of sediment toxicity for
  nonionic organic chemicals (Di Toro et al.). Trace/
  and Hansen (in press) also found that infaunal and
  epibenthic  organisms  accumulate   similar  con-
  centrations of nonionic organic chemicals regardless
  of feeding habit. This finding is important because it
  demonstrates that SQC must be derived to protect
  all benthic species, not just infaunal deposit feeding
  species. AED  scientists have also observed that
  metabolic  alterations of PCBs  in certain marine
  organisms  resulted in changes in the  abundance of
  individual  coplanar  or mono-ortho  substituted
  congeners (Lake, Haebler et al.  1995).
Recent scientific discoveries have resulted in a better
understanding of the environmental phases that control
the biological availability of environmentally important
metals. This research was detailed in a report in 1995 to
the EPA Science Advisory Board (SAB) on the technical
basis for predicting metal bioavailability in sediments and
deriving SQC for metals and was reviewed by the SAB this
year.

* AED scientists   provided evidence to  support
  previously published EqP-based hypotheses that the
  toxicity of metals-contaminated sediments can be
  predicted  using  SEM/AVS  ratios  and  interstitial
  metals concentrations (Pesch et al.). These experi-
  ments demonstrate that toxicity was absent when
  SEM/AVS ratios were 
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                                                                              NHEERL FY95 ANNUAL REPORT
                                                                               ATLANTIC ECOLOGY DIVISION
       Global Change Issues (Ozone, UV-B, and the Carbon Cycle)
Ongoing  global  change  research  has  successfully
addressed aspects of the probable effects of stratospheric
ozone loss resulting in UV-B increases and global warming
on marine ecosystems. This research has addressed how
changes in marine production could modulate changes in
the rate of atmospheric C02 increase (i.e., either amplify
or slow the rate of atmospheric CO2 increase) and thus
affect past and current rates of climate change.

*  AED scientists have performed research to address
   the issue of potential adverse effects of increased
   UV-B due to stratospheric ozone loss, (Vassiliev et
   al.).  They  have demonstrated that  even  100%
   increases in winter-time  UV-B may not adversely
   affect the  light  harvesting efficiency  and phyto-
   plankton  production  in  productive  well-mixed
   coastal systems.  However,  even  ambient UV-B
   levels may  inhibit light harvesting efficiency and
   phytoplankton production in clear waters typical of
   the open sea.

*  NHEERL/AED collaborators have demonstrated that
   carbon fixation in major regions of the open sea is
   limited by low aeolian flux of iron; therefore past
   and future changes in iron flux to the surface ocean
   may affect atmospheric CO2 concentrations. Both
   the scientific and policy aspects of this important
   debate have been addressed (Chisholm).
Major uncertainties exist concerning the understanding of
the global carbon cycle.

* AED scientists have developed (e.g., Bender et al.)
  and applied (Keeling, in press; Keeling and Peng, in
  press) methods to reduce major uncertainties in the
  global carbon cycle by more precisely estimating the
  magnitude and  trends in biologically  mediated
  carbon fluxes. This research has demonstrated that
  recently the net loss of carbon from the terrestrial
  biosphere may be close to zero; thus, carbon losses
  due to deforestation must be offset by carbon
  accretion  elsewhere in  the terrestrial biosphere.
  Considerable uncertainties remain, but this finding is
  recognized as one of the major FY95 accomplish-
  ments of the entire U.S. Global Change Research
  Program (USGCRP).
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 NHEERL FY95 ANNUAL REPORT
ATLANTIC ECOLOGY DIVISION
Table 22. AED Issues and Accomplishments Overview
  Ecosystem Health and Integrity
  Issue
 How may estuarine ecosystems be better
 characterized in terms of their response to natural
 and anthropogenic stressors?
•  Developed an innovative device for characterizing and predicting the entrainment of
   sediments.
•  Demonstrated nutrient inputs and cycling with respect to nitrogen and phosphorus in
   Chesapeake Bay and selected tributaries.
  How may the accumulation of anthropogenic
  contaminants at various trophic levels in the food
  chain be characterized?
*  Quantified contaminant concentrations in two bivalve species and provided information
   concerning the histological effects of contaminants in another bivalve species.
•  Provided information useful for estimating biomagnification of contaminants.
  Ecological  Significance  and  Extrapolation Ecology
  Issue
 What can be done to reduce uncertainty with
 respect to the effects of environmental stressors on
 ecological systems?
   Addressed questions of extrapolation ecology to lay groundwork for extrapolation
   research to be conducted in ecological significance.
   Evaluated mechanisms involved in contaminant uptake and sensitivity of brown cells
   found in commercially harvested hard clams.
   Provided new information through analyzing stress protein accumulation in mussels to
   help identity tissue systems most susceptible to chemical stressor damage.
  How can we better understand the causes and
  significance of effects at higher levels of ecological
  organization?
   Found evidence to indicate species interaction as a significant factor in appearance of
   anthropogenic stressor related disease.
   Provided life history traits for fish species to lay foundation for population dynamics
   model.
   Evaluated ecological risks to upper-water column species of municipal sewage
   dumping.
  Integrated Ecological Effects Assessment
 Issue
 What is the validity of a systems approach and an
 Ecological Risk Assessment (ERA) perspective for
 performing exposure and effects assessments to
 evaluate potential ecological and human health
 impacts?
   Confirmed validity of original assessments that used ecological and human health
   systems approach and ERA to predict effects of sludge dumping.
 What is the relevance of conceptual modeling and
 EPA's Framework for Ecological Risk Assessment
 for predicting population-level responses?
•  Illustrated how modeling and EPA's ERA Framework could be used to generate
   ecologically relevant information useful to environmental managers.
  How can contaminant-related ecological indicators
  help us understand past contamination and estimate
  future trends?
    Examined historical input of organic contaminants to an urban estuary and constructed
    a mass balance model.
  How can we specify and quantify causal links and
  input/output across system boundaries in developing
  conceptual models to address eutrophication of
  estuarine systems?
    Reported on transition between phosphorus limitation (fresh water) and nitrogen
    limitation (seawater).
    Showed direct relationships between annual nutrient input rate, water column and
    sediment nutrient stocks, and nutrient losses via burial in sediment and denitnfication.
    Also identified areas of major uncertainty.
50
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                                                                                                    NHEERL FY95 ANNUAL REPORT
                                                                                                    ATLANTIC ECOLOGY DIVISION
  Ecological Risk Assessment
  Issue
AED Accomplishment
  How can toxicity identification evaluation (TIE)
  approaches employing biologically directed chemical
  fractionation and equilibrium partitioning (EqP) be
  used to characterize risks to the marine
  environment?
    Showed that a combination of marine toxicity, TIE procedures, and historical data can
    be used to increase understanding of ecological risks of toxic effluents.
    Demonstrated the utility of marine clams for testing sublethal effects of sediment-
    associated contaminants.
  How can sediment quality criteria (SQC) be derived
  to predict sediment toxicity for nonionic organic
  chemicals?
    Described EqP approach as scientific basis for derivation of SQC and prediction of
    sediment toxicity for nonionic organic chemicals.
    Demonstrated need to derive SQC to protect all benthic species.
  What environmental conditions determine biological
  availability of metals in sediments?
    Provided evidence to support use of SEM/AVS ratios and interstitial metals
    concentration to predict toxicity of metals-contaminated sediments.
    Showed that toxicity of a trace metal (bioavailability) in surface waters is dependent on
    the physical and chemical form of the metal.
  How can changes in marine production modulate
  changes in the rate  of atmosphere CO2 increases
  and thus affect past and current rates of climate
  change?
    Demonstrated that even 100% increases in winter UV-B may not adversely affect light
    harvesting efficiency and phytoplankton production in productive, well-mixed coastal
    systems. However, even ambient UV-B levels may inhibit production in clear open sea
    waters.
    Demonstrated that carbon fixation in major regions of the open sea is limited by low
    aeolian flux of iron, thus, past and future changes in iron flux to the surface ocean may
    affect atmospheric CO2 concentration.
  How can we reduce major uncertainties in the
  global carbon cycle?
    More precisely estimated magnitude and trends in biologically mediated carbon fluxes.
    Demonstrated that net loss of carbon from the terrestrial biosphere may be close to
    zero, so that  loss due to deforestation must be offset by carbon accretion elsewhere in
    the terrestrial biosphere.
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                                                                               NHEERL FY95 ANNUAL REPORT
                                                                                   GULF ECOLOGY DIVISION
Important Scientific Issues
    The goal of GED is to protect and
    preserve the living resources of the
Gulf of Mexico and similar environments
by developing scientific  procedures to
characterize the ecological condition of
coastal  areas,  describing causes  and
evaluating rates of decline, establishing
datasets and methods to predict future
conditions.

The Gulf of Mexico's ecosystem is  large
and  diverse.  Information  about  this
system is  provided  below in Table 23.
Significant  Aspects of the Gulf of Mexico.


Issues	
Problems, such as  the  following, are
being identified in the Gulf area  with
increasing frequency.

• Fish kills  and  toxic  red  tides  and
  brown tides have increased in number
  and severity. More than half of the
                                        shellfish-producing  areas  along  the
                                        Gulf  Coast  are   permanently   or
                                        conditionally closed as a  result of
                                        contamination from increasing human
                                        and animal  populations in  coastal
                                        areas.

                                     •  Hypoxic  zones  have been  docu-
                                        mented off the Texas and  Louisiana
                                        coasts. The largest of these hypoxic
                                        areas was estimated to  be greater
                                        than 9,000 km2.

                                     •  Gulf shorelines are eroding at rates as
                                        rapidly as 30 m each year. Many of
                                        the environmental  quality problems
                                        may result from natural processes as
                                        well as from anthropogenic (human-
                                        induced) pollution or combinations of
                                        stressors, such as variations in climate
                                        and pollution.

                                     Refer to  Table 24.  GED  Issues  and
                                     Accomplishments Overview for a quick
                                     look at some of the major accomplish-
                                     ments of Fiscal Year 1995.
 Table 23. Significant Aspects of the Gulf of Mexico
  Geographic   The Gulf itself covers more than 1.6 million km2 and receives water from 33
  Area        major river systems, 207 estuaries, and the Mississippi River (approximately
              two thirds of the contiguous U.S. land mass).
              Contains coastal wetlands estimated at two million hectares and represent
              about half of all wetlands in the United States.
              Coastline is 2,609 km (longer than the Pacific coastline of CA, OR, and WA)

  Significant     Gulf of Mexico waters and coastal wetlands are essential habitats for many
  Wildlife      migratory waterfowl, as well as gulls, terns, and otfier shorebirds.,
              Endangered and threatened species include:
              •  Five whale species (four baleen and one toothed whale species)
              •  Crocodile (loggerhead, green, leatherneck, tiawksblll)     ..
              •  Kemp's Ridley turtles                           .    	
              •  West Indian Manatee                         -   .';'"   ',"  "
              Annual fishing yields (over 1.7 billion pounds) of finfish,!
              are greater than in South and Mid-Atlantic, Cl*
              region combined.

              In addition to commercial and
              known for its vatu:
           Gulf

  Ecology

 Division

The Gulf Ecology Division
  (CED) is responsible for
   studying the physical,
 chemical, and biological
     dynamics of coastal
wetlands, estuaries, bays,
  and near-shore marine
         environments.
Natural
Resources
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NHEERL FY95 ANNUAL REPORT
GULF ECOLOGY DIVISION
Uncertainties
Protecting unique Gulf resources is a difficult task that is
exacerbated   by  the  lack  of  complete  scientific    •
information. In order to reduce these uncertainties and    .
maintain public trust  in  EPA decisions, GED has
continued to provide national environmental  scientific
leadership through the following four activities.

FY 1995  Accomplishments
  Developing test methods
  Identifying and applying biological indicators
  Developing and validating predictive models
  Investigating microbial ecology
The following pages present GED's accomplishments that address areas of uncertainty as they relate to important
national and regional issues.
         Developing Test Methods
Biologically and ecologically meaningful test methods are
needed to reduce uncertainty in the use of single-species
toxicity tests  concerning potential hazards of toxic
chemicals, pesticides, and genetically modified organisms.
Current test methods in marine systems rely on deter-
mining the effects of high-dose, short-time exposure to
chemicals on the mortality of a few selected species of
individual  organisms during their most sensitive life
stages.

Methods are needed for determining the effects of complex
chemical mixtures, under chronic, intermittent, and other
exposure regimes. There is also a need for information on
the toxicities of novel stressors, such as microbial pest
control  agents,  on nonstandard test  species  and  on
populations and communities of organisms are also needed
to provide realistic hazard assessments. Significant scientific
uncertainty exists  when using such data to predict the
effects of exposure  of aquatic organisms  to complex
chemical mixtures, low concentrations of toxicants over long
periods of time, and effects at the population, community,
and ecosystem levels of biological organization. Similar, if
not greater, scientific uncertainties exist in conducting
hazard assessments of novel stressors, such as microbial
pest control agents, on marine systems.

 * GED scientists developed and evaluated toxicity test
   methods for estuarine  organisms,  which included
  screening for adverse effects at the organism (survival
  and reproduction), population (competition for space),
  and community (recolonization) level.

*• GED scientists initiated development of a reproductive
  bioassay based  on immunochemical detection of P-
  glycoprotein.

*• GED scientists studied the effects of scale (container
  size as related to the toxicity of pesticides and benthic
  community colonization) reporting that minimal size
  requirements were  necessary  to ensure  reliable
  colonization to benthic community.

*• GED  scientists  provided  information   concerning
  standard and innovative statistical techniques for the
  extrapolation of  limited toxicity data to alternate
  species   and  alternative test  concentrations  of
  contaminants.

Environment-modifying factors can have important effects
on the sensitivity  and life  history characteristics of the
important test species, marine mysids.

* GED  scientists performed research  to determine
  optimal temperature and salinity ranges for the marine
  mysid. This information will be used to increase the
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  efficiency of  culturing and  development of more
  reliable test methods for this important test species.

*• In a similar study, GED scientists analyzed effects of
  water temperature   on  shrimp  maturation  and
  spawning in order to improve culture  and testing
  performance.

*• GED scientists emphasized the use of aquatic plants to
  monitor environmental  change.  Use of plants is
  important because animal test species are the focus of
  most toxicity tests and can lead to incomplete hazard
  assessments for toxicants.
*• GED scientists evaluated a new method to detect
  Perkinsus marinus disease in oysters. This method may
  be the most valuable of those that exist because it uses
  all oyster tissues.

Results of the above studies have advanced knowledge in
the following areas.

• Application of current toxicity tests
• Productivity and reliability of laboratory toxicity tests
• Relevance  of the results of environmental hazard
  assessments
       Biological Indicators of Ecological Condition
The selection and use of bioindicators is very important
because they will be  used to  quantify the health of a
population or community of aquatic vegetation-fish-shellfish
or of an entire ecosystem. They are useful in diagnosing the
most probable cause(s) of observed abnormalities. They also
provide a means to evaluate the ecological condition of bays,
estuaries, and wetlands of the Gulf of Mexico and similar
system,  as well as to determine the sources and causes of
"stressed" systems. The goal is to identify and field-validate
biologically relevant measurements that quantify the health
of a population or community of aquatic vegetation-fish-
shellfish or  of an entire ecosystem,  with  reasonable
certainty.

*• GED  scientists monitored the physiological conditions
  of  oysters (in  several  studies)  in   response  to
  environmental conditions. Effects on digestive tubule
  atrophy, defense-related hemocyte activity, and tissue
  burdens were  analyzed. Generally, histological and
  physiological characteristics of oysters are reflective of
  the quality of their habitat and  can  serve as effective
  bioindicators.

*• GED  scientists investigated the use of fish as sentinel
  species, using blood serum collected from various fish
  obtained from polluted and unpolluted areas. Studies
  have  emphasized  vitellogenin  as  a bioindicator of
  exposure to  environmental estrogens  as well as
  immunohisto chemistry and serum chemistry tests to
  relate chemical exposure to environmental effects.
 3£ Future Effects: Results of the above research have been
 promising, and » bioassay rnay soonbe developed.
  GED scientists found that Rivulus and Medaka fish
  appear to provide excellent physiological models for
  studying the interacting factors that  result in the
  development of cardiac neoplasms. It was found that
  development  of  germ  cell  neoplasms used  in
  carcinogenesis tests was due more to age than to
  chemical exposure with Medaka. It is important to
  develop non-mammalian models for elucidation of the
  cancer process.

  Research was performed by GED scientists to evaluate
  selected bioindicator efficacy in large-scale monitoring
  programs.  Results demonstrated that macro-benthic
  community  parameters,  fish  blood   chemistry,
  eutrophication measures, fish community parameters,
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  sediment chemistry and toxicity, stable isotopes, and
  frequency and duration of hypoxic events can be used
  effectively  to  indicate  the  condition  of  regional
  estuarine  resources.   Numerous  alternative  bio-
  indicators were rejected, at least for the present, as
  having limited  specificity, high levels of uncertainty
  associated with the measurement, or an inability to be
  rigorously interpreted.
  GED  scientists  applied  bioindicators  to  assess
  environmental  condition  by  using  phytoplankton
  productivity and dissolved oxygen patterns to evaluate
  eutrophication potential  in  Perdido  Bay,  FU/AL
  Selected  fish  species (Rivulus  marmoratus)  distri-
  butions were used to examine damage to mangrove
  ecosystems  caused   by  global  climate  change.
  Eutrophication is one of the major stressors affecting
  coastal resources today. The development of strong
  bioindicators that can mimic or predict the advent of
  eutrophication     through     nutrient    additions
  (productivity)  or process-mediated  rate  changes
  (global climate change) provide important tools for our
  understanding  of the eutrophication process  and,
  subsequently, strategies to control it.
D!
    |[] Development and Validation of Models
GED  scientists  have  performed modeling research
designed to:

• Identify problem areas in the Gulf of Mexico
• Document the ecological effects at multiple levels of
  biological organization
• Determine causal factors
• Provide  research  recommendations regarding the
  source(s) of  pollution and  unacceptable pollution
  stressors
• Predict future ecological conditions if circumstances
  remain unchanged or if pollution loads are varied

The research effort is  divided into the  two areas of
effects models and assessment of ecological conditions
across spatial scales.

Effects Models	
It is now possible to make reasonable assessments regarding
the direct effects of individual chemicals and pesticides on
a  variety  of representative   aquatic  organisms.  The
interacting  effects of dynamic changes in  environmental
conditions,  pollution load, and combinations of pollutants
and natural pathogens are largely unknown; and effects,
particularly indirect effects, at the population, community,
and ecosystem levels are difficult, if not  impossible,  to
predict. Research  is directed to resolving some of these
uncertainties.

*• GED  scientists developed  and  validated  a new
  statistical  method to predict chronic  toxicity from
  acute  toxicity data for aquatic life. Chronic toxicity
  testing is time-consuming,  tedious, and  expensive.
  Acute testing  is  rather  short in duration,  more
  tractable, and  less expensive. The development  of
  statistical tools to  predict chronic effects from acute
  testing will result in savings in time and money because
  most toxic effects "observed" in nature are chronic.
  These tools will make it easier to identify chronic toxic
  effects in natural populations and to separate these
  effects for natural variability.

*• GED   scientists    developed   a   method  for
  modelingaquatic toxicity data based on the theory of
  accelerated life testing.  Benefits of this method include
  the integration  of effects, dose, and exposure duration
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  in toxicity tests.  The statistical  procedures  were
  performed by computer and will reduce the amount of
  toxicity testing necessary to characterize the chronicity
  of chemicals. They will also provide scientists with a
  more  accurate procedure  for  analyzing  chemical
  effects.

* GED scientists performed  research  to determine
  relative sensitivities of metals and pesticides on  mysid
  and penaeid shrimps. The scientists found that Mysids
  were more sensitive in  most  cases,  but the results
  were contaminant-specific.

*• GED scientists performed research to determine the
  effects  of fungal  weed and  insect  microbial pest
  control  agents for  embryos,  larvae  and  adults of
  marine fish and shrimp. The effects, in  some  cases,
  indicated probable negative environmental impact.
 •£? Future Effects: Penaeid shrimp are of tremendous importance
 to the commercial and ecological welfare of Gulf of Mexico!
 ecosystems.  Determining the  relative  toxicities  of  typical
 concentrations of chemical stressors will permit our assessment of
 important commercial species using tests that employ common,
 easy-to-rear, inexpensive mysids.	j
  GED scientists demonstrated the relative toxicity of
  fuel oil,  fuel oil  dispersant, and  fuel oil-dispersant
  mixture by exposing embryos of the inland silversides.
  Oil dispersants were more toxic than oil itself when
  tested separately, and the fuel oil-dispersant combi-
  nation was more toxic than  either the oil or the
  dispersant alone (however, results  were dispersant
  specific).  These studies illustrate  the  difficulty in
  generalizing toxicity data without an appreciation of
  environmental variables.
                        , this t)f»e of research souW Wcate
 which oti aispersant, used alone or in combinations for control of oil
 spills,                 '
Assessment of Ecological Condition
The  Environmental   Monitoring   and  Assessment-
Estuaries Program provided a regional assessment of the
health of bays and estuaries of the  Gulf of Mexico
(Louisianian Province).

In order to advance the research of the Louisiana Province
study, GED  scientists  are continuing  research to provide
assessments of individual bays and estuaries as well as
individual  ecosystems  and  their   components   (e.g.,
submerged aquatic vegetation, benthic communities, etc.).
This has  led  to  the  emphasis of  development, field
validation, and application  of biological indicators  for
identifying  stressed  populations,  communities,  and/or
ecosystems and for the establishment ofbiocriteria.

* GED scientists evaluated the effects of copper-treated
  pilings  on  resident  oysters.  Results indicate that
  copper-treated pilings are a significant stressor to
  these bivalves.

*• GED scientists demonstrated that tumors of fish
  collected from the Gulf of  Mexico and  from a
  freshwater  lake  identified the first case of a liver
  neoplasm for the common carp. These descriptions of
  tumors resulted from the use of wide-scale sampling
  to  characterize  population-level  occurrences  of
  pathologies (Summers et al.). This description  of a new
  case of pathological incidence, like any first-reported
  case,  significantly  advances  our  knowledge and
  understanding   of  disease   distribution    and   its
  prevalence and  importance at a population level  rather
  than simply at an individual level.

*• GED scientists compared serum  chemistries  for
  brown   bullheads   collected   from  polluted and
  unpolluted  rivers.  Of the  20  serum  parameters
  considered, seven were higher in  fish collected from
  the polluted area, thus demonstrating usefulness as
  biomarkers of ecological condition.
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*• GED scientists were able to leverage the work of
  ORD's  Environmental Monitoring and  Assessment
  Program-Estuaries as they modified their approach to
  examine the condition of a specific estuary in the Gulf
  of Mexico (Perdido Bay) and to postulate designs for
  other systems  (Mobile  Bay, Galveston  Bay, Tampa
  Bay). The regional assessments of condition provided
  the first comparative assessment of estuarine condition
  on large regional scales that utilized the same design,
  indicators,   methods,   and   assessment   statistics.
  Regional assessments  that  permit  comparison  at
  common ecological  and geographical scales, using
  common indicators, allow us to look at the regional-
  relative risk of estuarine resources throughout the
  nation. This relative risk permits a baseline from which
  to assess change and permits a reasoned process of
  allocation of resources that is problem-driven.
     Microbial Ecology
Microorganisms are critical to the cycling of C, N, P, S
and  many  other elements  in the environment.  The
balance of these cycles is, in turn, critical to supporting
the higher trophic levels composing our wetlands and
other  coastal  environments.  Physical, chemical,  or
biological stressors that can upset the balance of these
cycles  can  present a risk to a stable  and productive
environment. Understanding the  inter-relationships of
these cycles, the key organisms involved, the response of
organisms to environmental stress, and the  effects of
nutrient and chemical cycling are vital to developing
sound  measures of risk that can be used to evaluate
environmental problems.

Numerous naturally occurring, complex compounds and
chemicals exist in terrestrial, freshwater, and marine
systems. These natural chemicals and compounds, as well
as anthropogenic chemicals and compounds, undergo
transformation  and are  biogeochemically cycled within
the biosphere by microorganisms.  Knowledge regarding
the rate of degradation, metabolic processes, and identity
of intermediate degradation products is generally lacking,
but is important for assessing the risk and burden of toxic
chemicals to ecological systems.
Elemental Cycling
Understanding the cycling of elements such as mercury in
the  environment  is  essential  to  defining  potential
environmental hazards. Research efforts have contributed
greatly to our understanding of the environmental effects of
mercury. Progress has been made at the environmental,
microorganism, and genetic levels.

+  Research by GED scientists has led to a method that
   estimates the level of expression of the merA gene in
   environments. This method can be used to estimate
   how  actively  microorganisms are  modifying  the
   chemical form of mercury in the environment and how
   these organisms participate in the cycling of mercury.
 to pathways for the degradation of hazardous organic chemicals will
 revolutionize the study of biological activity in the environment. This
 is because it allows us to measure benchmarks for degradation rates
 to the actiyeiy-degradlrg organisms.      	
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Biodegradation Processes
An understanding of the fate of toxic organic chemicals in
the environment advances  research to evaluate the
potential for ecological effects from hazardous wastes.

GED  scientists  performed  research  to  advance  the
understanding  of microbial communities and pathways
involved  in  the  degradation  of  polycyclic  aromatic
hydrocarbons (PAHs). Microbiological tools were developed
to investigate chemical availability which relates to both the
potential toxicity of these chemicals and their degradation
or  transformation  by   microorganisms.   Determining
bioavailability can result in better estimates of risk to the
environment.

* GED scientists  developed a monoclonal  antibody
  technique  to help track organisms that  degrade
  trichloroethylene. This tool can be used to understand
  the environmental  behavior of these organisms. In
  some  cases,  the genetic  composition of  micro-
  organisms must be altered to enhance the degradation
  process. Detecting and enumerating these genetic
  alterations requires very sophisticated procedures.
  Chromogenic  (color   forming)  reactions  were
  developed for monitoring the  genetic  transfer of
  dioxygenase genes among different  bacteria. This
  enzyme is crucial to initial steps in the degradation of
  many mutagenic PAHs.

*• GED  scientists  performed  research  to   advance
  understanding of the non-specific transformation of
  chemical components that can occur when chemical
  stressors are present as mixtures. In some cases, the
  intermediates are more stable and more toxic than the
  original mixture.
 & Future Effects: Understanding the process leading to these
 transformations and characterizing the microorganisms Involved, will
 ultimately provide better toots for estimating the environment^ risk
 posed by mixtures of hazardous chemicals.	
Biotechnology Risk Assessment	
Biochemical,  physiological  and  environmental  factors
influence survival, fitness,  and competitive potential of
genetically  engineered  organisms  (GEMs),  introduced
nonendemic  organisms,   and  viruses.  Evaluating  the
importance of these factors  is critical to  assessing and
predicting ecological impacts of these organisms.

*• GED  scientists  assessed the transfer of conjugal
  plasmids from GEMs to  indigenous microflora and
  evaluated the effects of introduced microorganisms on
  freshwater, marine, and terrestrial ecosystems in single
  species,  multispecies, and site-specific microcosms.
  This research investigated the potential for transfer of
  genes from introduced  organisms to  indigenous
  organisms, environmental factors that can contribute
  to the survival of organisms in the environment, and
  the construction of suicide genes to limit the survival
  of   genetically  engineered  organisms  in   the
  environment.

*• GED scientists  developed  a  very efficient  suicide
  function  based on  a lethal E.coli gene.  More  than 7
  orders of magnitude reduction in suicide bacteria has
  been achieved  in soil.  Adding these  genes  to a
  genetically engineered organism would greatly  reduce
  its ability to survive in the environment and  would,
  therefore, reduce the risk of using the organisms.

* GED scientists performed research using I6S rRNAto
  characterize  environmental   communities.   The
  importance of this technique as it relates to  under-
  standing the composition of microbial communities is
  only now becoming apparent. Using this technique,
  GED scientists are investigating  the composition of
  microbial communities involved in nitrogen cycling in
  anaerobic environments and how changes in these
  communities affect nitrogen cycling and, ultimately, the
  viability of submerged aquatic vegetation that inhabit
  this environment.
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Table 24. CED Issues and Accomplishments Overview
  Test Methods  Development
  Issue
GED Accomplishment
  How may testing methods be advanced in order to
  increase confidence in forecasts of potential
  ecological hazards?
    Developed and evaluated test methods with regard to contaminant effects on estuarine
    organisms.
    Developed initial steps for creation of a reproductive bioassay using immunochemical
    detection of P-glycoprotein.
    Increased  information on effects of scale on toxicity of pesticides to benthic community
    colonization.
    Advanced  knowledge of standard and innovative statistical techniques for extrapolation
    of limited toxicity data to alternate species and various contaminant concentrations.
  What are the effects of environment - modifying
  factors on important toxicity test species?
•   Determined optimal temperature and salinity ranges for increasing efficiency of
    culturing and test methods development for the marine mysid.
•   Increased information on water temperature effects on shrimp maturation and
    spawning.
  How may the use of new toxicity test results
  enhance laboratory method productivity in
  environmental risk assessments?
*   Broadened application of toxic risk assessment process by using aquatic plants (instead
    of animal species) to monitor environmental change.
*   Increased knowledge of the value of a new method for detecting Perkinsus marmus
    disease in oysters.
  Biological  Indicators of Ecological Condition
  Issue
GEP Accomplishment
  What reliable biological indicators are needed to
  evaluate bays, estuaries, and wetlands and to
  determine the sources and causes of "stressed"
  systems?
  Ecological Models for Spatial Scales
    Demonstrated the value of oyster histological and physiological characteristics as
    effective bioindicators.
    Demonstrated the use of Rivulus and Medaka (fish) as excellent physiological models
    for neoplasm development.
    Demonstrated the value to large-scale monitoring programs of six specific groups of
    bioindicators.
    Demonstrated the utility of specific bioindicators in evaluating and predicting
    eutrophication levels.
  Issue
GED Accomplishment
  Can effects models be advanced to predict chronic
  effects from acute testing?
    Developed and validated a new statistical method to predict chronic toxicity from acute
    toxicity data.
    Developed aquatic toxicity modeling method that reduces required toxicity testing for
    chemical characterization and provides more accurate analysis of chemical effects.
    Determined relative sensitivity data that allows for extrapolation of metals and
    pesticides  effects from inexpensive mysid shrimp to important commercial species.
    Observed  probable negative environmental impact of fungal weed and insect microbial
    pest control agents.
    Advanced  knowledge of the environmental effects of oil dispersants (used for control of
    oil spills).
  What is being done to develop, field-validate, and
  apply biological indicators to identify stressed
  populations, communities, and/or ecosystems, and
  to establish biocriteria?
    Identified copper-treated pilings as stressors to oysters.
    Characterized population-level occurrences and proof of the first case of a liver
    neoplasm in common carp.
    Examined condition of Perdido Bay estuary, building on work of EMAP-Estuanes in
    Gulf, and provided first comparative assessment of estuarine condition on large regional
    scales using same design, indicators, methods, and assessment statistics.
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 Microbial  Ecology
 Issue
 What work is underway to advance knowledge of
 the cycling of elements such as mercury in order to
 define the potential environmental hazard?

 What is being done to advance understanding of
 degradation pathways of PAHs in the environment
 and to elucidate the chemical bioavailability of
 these compounds?
•   Developed method to estimate level of expression of merA gene in environments.
•   Developed monoclonal antibody technique to help track organisms that degrade
    trichloroethylene.
•   Developed chromogenic reaction for monitoring transfer of dioxygenase genes among
    different bacteria.
•   Advanced knowledge of effects of mixtures of hazardous chemicals.
  How can we evaluate the importance of
  biochemical, physiological, and environmental
  factors as a critical part of assessing and predicting
  ecological impacts of genetically engineered
  organisms (GEMs)?	
    Assessed transfer of conjugal plasmids from GEMs to indigenous microflora and
    evaluated effects of "introduced" organisms to indigenous organisms.
    Used 16S rRNA to characterize environmental communities.
    Developed very efficient suicide function based on a lethal £. Coli gene.
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                                                                       MID-CONTINENT ECOLOGY DIVISION
Important Scientific  Issues
      MED-Duluth  strives  to  develop
      mechanistic  understandings  to
establish cause and effect relationships
for stressors already in the environment
and to  predict  potential  responses of
stressors not yet present or released.

Research  at MED-Duluth focuses  on
ecotoxicological responses of aquatic life
and  wildlife and effects  of  physical,
chemical, and  biological  stressors  on
freshwater ecosystems. MED projects
range from the investigation of cellular
responses as a means of understanding
the mechanisms of toxic  responses to
studies  of the  influence of watershed
characteristics  on the sustainability of
aquatic ecosystems.
                         Table 25. MED Areas of Investigation lists
                         research areas of investigation at MED.

                         MED-Duluth pursues these research
                         areas to support both prospective and
                         retrospective risk assessments through
                         the  development of sound methods,
                         models,  and data to screen, diagnose,
                         and predict ecological effects.

                         Refer to Table 26. Issues and Accomplish-
                         ments Overview, for a quick look at some
                         of the major MED accomplishments of
                         Fiscal Year 1995.
Table 25. MED Areas of Investigation
    Understanding and predicting basic biological and chemical mechanisms of toxicity
    Measuring and predicting the uptake, distribution, and elimination of toxic chemicals in aquatic life
    and wildlife
    Predicting the reproductive and developmental effects of chemical stressors
    Predicting the effects of mixtures and/or multiple stressors present in waters and sediments
    Characterizing and predicting thes responses of aqumtte eeosysteias to MmttAm.
causes
                           degr^
            Mid-
 Continent
      Ecology
      Division

 The Mid-Continent Ecology
      Division (MED-Duluth)
 provides scientific informa-
tion on ecotoxicological and
freshwater ecological effects
 to reduce the uncertainty in
 ecological risk assessments
          and support risk
       management option
              selections.
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FY1995 Accomplishments
        Mechanisms of Toxicity
Improved understanding of mechanisms of action and
xenobiotic metabolism of industrial chemicals is a critical
need in aquatic toxicology. Advances in these areas are
needed to improve prospective assessments where toxic
effects of untested chemicals must be  predicted from
chemical structure and for extrapolating toxic effects
across species.  Relationships of chemical structure and
properties to mechanisms of toxic action and xenobiotic
metabolism  represent major areas of uncertainty in
ecological risk assessments.

EPA  needs  to   advance   its  capability of  predicting
ecotoxicological effects for risk assessments of new (i.e.,  the
premanufacturing notice process) and existing chemicals
under  the  Toxic  Substances  Control Act  (TSCA),  for
chemical listing-delisting actions under the Clean Air  Act
(CAA) Amendments of 1990, and for identifying the relative
risk of compounds found at hazardous waste and Superfund
sites. EPA's Science Advisory Board has identified prediction
of ecotoxicological effects as essential to improving  our
ability    to   forecast   and   interpret   contaminant
bioaccumulation under regulatory mandates  of the Clean
Water Act (CWA). Information and models developed
through such research can help determine  appropriate
management and regulatory actions to prevent pollution or
to clean up chemical discharges and waste disposal sites.

*•  One of the techniques used to assess modes of toxic
   action involves investigations of the joint acute toxicity
   of binary chemical  mixtures where those chemicals
   with similar modes of action should produce additive
   responses when combined. MED scientists used  this
   technique  to  classify  a  diverse  set  of industrial
   chemicals  into several classes  of  narcotics   and
   uncouplers of oxidative phosphorylation (Broderius, et
   al.).
Metabolism of a chemical in an organism can also be
critical when  enzymatic  processes result  in  by-
products that  are  more toxic than  the  original
chemical.  Such chemicals can  elicit their adverse
effects through a number of different mechanisms.
Recent research by MED scientists on the relationship
between the electronic structure of chemicals  and
their activated metabolites is helping to improve our
ability to predict toxic  effects. These  studies have
addressed approaches to predicting the stability and
formation  of  reactive  intermediates that  can  be
associated with electrophile reactivity (Mekenyen et al.
"Stability  of organic  cation  intermediates")  and
oxidative stress (Bradbury et al., numerous works).

Some chemicals can be activated by processes that do
not  necessarily involve the organism's  enzymes.
Several classes of chemicals display increased toxicity
in the presence of sunlight (Ankley et al., numerous
works;   Monson et  al.).  MED   scientists  have
investigated  relationships between the electronic
structure of chemicals and their photoinduced toxicity
(Mekenyen et  al.,  numerous works;  Veith et al.
"Photoinduced acute toxicity of PAHs"; Veith et al.
"Alph-terthienyl Phototoxicity"). These studies have
shown that "phototoxic" polycyclic aromatic hydro-
carbons (PAHs) can be identified when the energy of
the electrons  in the  structures  is  calculated  and
interpreted in the context of environmentally relevant
ultraviolet light energies and intensities.
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                                                                            MID-CONTINENT ECOLOGY DIVISION
  Bffja
  ijrm Dosimetry
Ecological  risk assessments for chemical stressors to
aquatic life and wildlife typically require extrapolating
toxic effects across species and exposure routes  and
rates.  Consequently, interspecies  and dose-response
uncertainty factors must  be  employed to  estimate
responses  in  the  species of  concern  under varying
exposure conditions. Development of  physiologically
based  toxicokinetic  models  seeks  to  establish  a
mechanistically based framework to identify first-order
uncertainties underlying  interspecies differences. Such
models predict the uptake, disposition, and elimination of
chemicals  based  on  anatomical,   physiological,   and
biochemical attributes that are species-specific. In turn,
these  models  provide  important  insights  toward
improving the scientific credibility of species and dose-
response extrapolations in ecological risk assessments.

Ecological risk assessments for  chemical stressors suffer
from a need to advance current interspecies extrapolation
techniques. Such approaches typically rely on the use of
interspecies   uncertainty  factors   in  screening  level
assessments (e.g., new chemical evaluations under TSCA)
and/or statistical evaluations  of relatively large  sets of
toxicity data  (e.g., aquatic criteria developed  under the
CWA). With the increasing attention being placed on top
predators  and  wildlife,  where   reproductive   and
developmental responses following chronic exposure are of
primary interest, there is a need for increased understanding
of the mechanistic basis underlying interspecies differences.
As a consequence, the need for better understanding of the
accumulation of contaminants and their relation to toxic
effects has been widely recognized. Because testing is not
possible for all relevant species and endpoints, the strategic
use of predictive toxicokinetic models has  been identified
and endorsed by the CENR, ORD, the Office of Water,  and
EPA's Science Advisory Board,  as a  sound approach to
reduce interspecies and dose extrapolations.
Mechanisms  and rates of uptake, distribution, and
elimination of PCBs in tree swallows were studied by
Nichols et al. because the use of residues in  these
organisms is being considered as an indicator of local
sediment contamination. Evaluation of a bioenergetics
model  suggests  that more  research  on  dietary
composition and food  consumption rates is required
before these organisms can be used successfully as a
monitor of sediment contamination levels.

Schmieder et al. evaluated the uptake and elimination
of   2,3,7,8-tetrachlorodibenzo-p-dioxin  (2,3,7,8-
TCDD) in medaka, a small fish species. These studies
predicted a steady state bioconcentration factor from
water to fish tissue of over 500,000. This value is much
higher than those previously reported in the literature
and suggests a greater risk from accumulated 2,3,7,8-
TCDD than previously estimated.

Nichols et al. developed a technique for visualizing the
output  of   toxicokinetic models  that  employs
supercomputing  capabilities   to   communicate the
massive amount of data produced through associated
experimental and modeling studies. This  visualization
technique provides  a rapid  and  easily  understood
representation  of complex toxicokinetic  modeling
results.
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           Reproductive and Developmental Toxicology
Understanding  acute toxic effects of xenobiotics and
developing  associated  lexicological   methods  have
significantly improved the means to predict and interpret
the effects of  chemicals on aquatic  life and  wildlife.
However,  there is comparatively little  information
concerning the responses of organisms during chronic
exposures. Ecological  risk assessments are beset by
significant uncertainties in the extrapolation of effects at
the organism level  to effects at the population or
community  level.  MED  researchers  are working on
development of chronic test methods and establishment
of properly characterized dose-response relationships for
representative species across mechanisms of toxic action.
These techniques and predictive tools  will facilitate
extrapolation of ecological effects to higher levels  of
biological organization and will provide a basis to assess
interspecies susceptibility.

Increased attention  on reproductive and developmental
effects of chemical stressors on aquatic life and wildlife has
prompted ORD to establish a new program to address the
ability of certain classes of compounds to disrupt hormonal
control  of reproduction  and  development.  Increased
understanding in this  area  of  ecotoxicology  will be
particularly useful for development of water and sediment
quality criteria, registration of pesticides, and evaluation of
new and existing industrial chemicals.
  The effects of 2,3,7,8-TCDD on the early life stage
  development and subsequent fry survival of lake trout
  embryos were  investigated  in  the laboratory by
  Walker et al.  Routes  of exposure included the
  translocation of 2,3,7,8-TCDD from the adult female
  to oocytes, exposure of fertilized eggs to waterborne
  2,3,7,8-TCDD, and the injection of 2,3,7,8-TCDD into
  fertilized eggs.  Maternal transfer was sufficient to
  cause  dose-related  effects,  and  there  was little
  difference in response based on the different routes of
  exposure to the eggs.

  The effects of several pesticides on the reproductive
  success of bluegill sunfish were also investigated via
  field  methods  for conducting  and  interpreting
  reproductive studies using enclosures within portions
  of a lake (Tanner and  Knuth, Tanner and Moffett).
  Tanner and  Moffett  found that  the  effects of
  diflubenzuron on bluegill sunfish were not the result of
  direct toxicity of the chemical but rather were caused
  by a reduction in preferred food organisms that were
  directly  affected.  This study  demonstrated  that
  significant effects on aquatic organisms associated with
  assessment endpoints in ecological  risk assessments
  may occur at chemical concentrations lower than
  those expected based on laboratory toxicity data for
  these species.
         Chemical Mixtures And Multiple Stressors
Evaluation of ecological effects in aquatic systems often
includes an  assessment  of the  effects  of  multiple
stressors. Aquatic  life and  wildlife  are  exposed  to
complex chemical mixtures in water and sediments that
can cause synergistic, additive, or antagonistic responses.
Effects  of chemical  stressors  can  be enhanced  or
moderated based on the habitat characteristics of the
organisms. Consequently, understanding the interaction
of chemical and nonchemical stressors is fundamental to
improving both prospective and retrospective ecological
risk assessments. The development and validation of
techniques  to  identify  and  characterize  chemical-
mediated effects  in aquatic ecosystems is also needed to
advance the conduct of scientifically sound retrospective
risk assessments.
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One of the keys to understanding the effects of chemicals
on  the  environment  lies  in  the  development  of
approaches  for dealing  with the potential effects  of
bioaccumulative chemicals in sediments. A significant
research effort has been devoted to improving methods
for conducting  and interpreting  tests to assess the
ecological effects  and  bioaccumulation  of chemical
contaminants on sediment-dwelling organisms and their
predators. The forthcoming information can be used  by
EPA,  other  governmental  agencies, and the  regulated
community   to  help   evaluate  potential  chemical
contamination of sediments and biota and to determine
whether mitigation  action is indicated.

One application of  these data is  to  identify acceptable
thresholds or benchmarks  for sediment contamination.
These values can be used in prospective risk assessments
under the Clean Water Act to evaluate future and ongoing
chemical releases and in retrospective assessments where
the contribution of chemical contamination to an adverse
ecological condition must be evaluated and cleanup options
compared.  For example, sediment quality criteria are being
used in  the  Superfund program  as a  component in site-
specific risk assessments.

*• Research  conducted by MED scientists continues  to
  validate current methods of assessing the toxicity of
  contaminated  sediments.   These  studies  include
  comparisons  of  species sensitivity (Phipps  et al.),
  evaluations of the equilibrium partitioning method of
  predicting responses based on water concentrations
  (Hoke, Ankley et al.), and a general review of methods
  available for sediment tests (Ingersoll et al. "A review
  of methods and applications").

*• Sediment contaminant bioavailability is also critical to
  understanding  potential  impacts.  Methods  for
  measuring contaminants in  sediment interstitial water
  were developed and evaluated (Ankley and Schubauer-
  Berigan "Comparison of the techniques";  Kosian  et
  al.), as was the role of acid volatile sulfide (AVS) in
  binding with metals in  sediments (Leonard et al.).
*• The bioavailability and bioaccumulation of chemicals in
  sediments and surface waters are also important when
  trying to interpret the potential effects of wastewater
  discharges. A method to screen for the presence of
  chemicals that bioaccumulate in freshwater organisms
  was developed by Burkhard and Sheedy and found to
  correlate extremely well with environmental samples.

Understanding and predicting the toxicity of chemical
mixtures is a challenge that is still in its infancy. The use of
toxic equivalency factors (TEFs),  where the toxicities of
chemicals with a similar mode of action are assumed to be
additive, is being evaluated for chemicals thought to act
through the aryl hydrocarbon  (Ah) receptor. These TEFs
provide numerical comparisons of the potency of individual
compounds to that of 2,3,7,8-TCDD. The need to advance
an understanding of the interactive effects of PCBs, dioxins,
and furans has long been recognized by both the scientific
community and regulatory agencies as a central issue in the
ability  to assess  the ecological risk of these compounds.
TEFs have been developed that are based on ecologically
relevant endpoints for representative species (e.g., embryo
mortality in salmonids). As a result, the means to advance
scientifically defensible techniques to  diagnose and to
evaluate cause-effect hypotheses at existing contaminated
locations is now possible,  and  with it the  means of
monitoring and  ultimately controlling  future point  and
nonpoint releases.

*• Newsted et al. and Zabel  et al. developed TEFs for
  congeners of polychlorinated dibenzodioxins, furans,
  and  PCBs based on their effect on rainbow trout and
  compared the values  to  those  developed  for
  mammalian species. Although  TEFs for dioxins  and
  furans were similar to those developed for mammals,
  the relative potencies of some PCBs were lower in
  fish.

Although toxic environmental matrices (i.e., toxic effluents
or sediments) inevitably contain mixtures of chemicals, not
all of these chemicals contribute to any toxicity that might
be  expressed.   Understanding  which   chemicals   are
contributing to toxicity has been found to be a useful tool for
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EPA's Officer of Water, Regions, States and the regulated
community in evaluating pollution prevention and effluent
treatment options.

* Ankley and Schubauer-Berigan have described toxicity
  identification evaluation (TIE) procedures to diagnose
  the  primary chemical causes of acute  toxicity in
  sediments (Ankley and Schubauer-Berigan "Sediment
  toxicity  identification  evaluation procedures").  This
  technique  employs  a toxicity-based  fractionation
  scheme to implicate specific contaminants as causative
  toxicants.

The  toxicity  of some chemicals  is  also  affected  by
interactions with chemical and physical properties of the
aquatic environment. The absence of knowledge  of these
interactions can confound predictions of chemical effects
and  lead to  greater  uncertainties  in  pollution control
decisions. An  increased understanding of the role these
properties play in determining toxic responses will lead to
better  scientific decisions and  management actions to
prevent  undesirable   environmental   impacts.  These
interactions have been particularly problematic in  the
implementation of water and sediment quality criteria.

> The  toxicity of  some aromatic  hydrocarbons is
  increased by the presence of sunlight (Ankley et al.,
  "Influence of ultraviolet light"; Ankley et al., "Effects of
  light intensity"; Monson et al.). Ultraviolet light
  activation can increase toxicity in direct proportion to
  the intensity and  energy of the light. As a  result,
  toxicity  test  results  for  chemicals  that  can  be
  photoactivated may be  underestimated  by several
  orders  of magnitude when the  compounds  are
  evaluated under normal laboratory lighting.

  The  toxicity of  ammonia can  be  affected  by
  temperature and pH because of their effect on  the
  chemical equilibrium between ionized and unionized
  ammonia. Because ammonia is a common sediment
  constituent, the influence of pH on the acute toxicity
  of ammonia to benthic organisms has been studied
  extensively  (Ankley et  al.  "Influence of  pH and
  hardness"; Schubauer-Berigan  et al.; Whiteman et
  al.).These recent MED studies showed that,  unlike
  responses previously reported for other organisms,
  the  toxicity of  total ammonia to  a  freshwater
  amphipod (Hyalella  azteca)  in soft water  was  not
  influenced by pH.

  Water quality characteristics can also affect the toxicity
  of metals. Erickson et al. reported the results of an
  extensive investigation  of factors  influencing  the
  toxicity  of  copper.  They found that while  many
  parameters  (i.e.,  pH, hardness,  dissolved organic
  carbon) reduced toxicity,  these effects were not solely
  a function of copper speciation, as is often cited.
         Measuring and
Current attempts  at ecological  risk assessments  and
predictions of the  effects of anthropogenic stressors on
natural ecosystems  are often made  with incomplete
knowledge of the system at risk. Such predictions of effects
that are based on laboratory test results do not include the
influences of habitat modifications or species interactions.
An improved understanding of ecosystem organization and
dynamics is necessary to reduce uncertainty in predicting
effects on aquatic ecosystems. Increased knowledge is also
needed of responses over various time and spatial scales;
          of Aquatic Ecosystems
interactions within ecosystems that influence both direct
and indirect effects; and uncertainty associated with using
laboratory data to predict the response of aquatic systems
to chemical, biological,  and  physical stressors. Such
information is required to determine the degree of exposure
to chemicals that aquatic ecosystems can safely withstand
as well as to evaluate the relative contribution of various
potential  stressors  on  these  systems.  With greater
knowledge, water resource managers can make decisions to
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utilize mitigation procedures and resources efficiently where
they will provide the greatest environmental protection.

+ Much of the information currently available to predict
  the  responses of aquatic  ecosystems to chemical
  stressors comes from laboratory toxicity tests. Ankley
  discussed some of the limitations in extrapolating from
  laboratory-based sediment assessment techniques to
  the field. Major drawbacks include the limited number
  of methods for testing chronic effects and the lack of
  a mechanistic understanding of the relationship of
  single-species endpoints to population and community
  endpoints.

* To investigate the effects of chemicals on freshwater
  ecosystems, a method  of enclosing portions of a lake
  was developed and used  to study two  pesticides
  (Knuth  and Heinis, Stay and Jarvinen, Tanner  and
  Knuth, Tanner and Moffett). These studies related the
  fate and distribution of the chemicals to effects on the
  ecosystem.  Effects  occurred directly through toxic
  responses as well  as indirectly through changes in food
  web dynamics.
         Watershed Characterization
Ecological risk assessments have traditionally focused on
immediate impacts to single populations or ecosystems
from single chemical stressors. In reality, the sustainability
of aquatic ecosystems in relation to human  impacts
depends on the ability of these systems to withstand
and/or recover from multiple anthropogenic and natural
stressors. Because aquatic ecosystems depend on the
exchange  of materials  and  energy from  terrestrial,
geologic, atmospheric, and other aquatic systems, the
protection of an aquatic ecosystem is intimately coupled
to protection of the surrounding watershed.  Research is
being  directed toward understanding the  functional
linkages   between   ecosystem  components  within
watersheds, the degree to which spatial and temporal
landscape patterns influence aquatic ecosystems, and the
nature of cumulative impacts at the watershed scale.
  In  addition  to  chemical  stressors,  changes  in
  environmental conditions are important controlling
  variables  in  determining  the  health   of  aquatic
  ecosystems. A technique for determining the thermal
  requirements for freshwater fish based on an extensive
  database of field measurements was reported and then
  used to evaluate the potential effects of global climate
  change on the distribution of 57 species of fish (Eaton
  et al. "Estimating fish temperature tolerance"; Eaton
  and Scheller). The results indicate that temperature
  shifts, as predicted by a doubling of the atmospheric
  carbon dioxide concentration, would result in a 50%
  reduction in the habitat for cold and cool water fish
  throughout the existing range of these species.  This
  database was also used to help develop and validate a
  model that simulates fish habitat in lakes and streams,
  as defined by  temperature  and dissolved  oxygen
  concentrations  (Sinokrot et al.;  Stefan,  Fang et al.;
  Stefan et al. "Fish habitat model"; Stefan et al. "Fishes
  in Minnesota lakes").
Wetlands are an important component of watersheds that
are often  subject to physical,  chemical,  and biological
stresses. EPA is  concerned with obtaining an improved
understanding  of the  roles  that  wetlands serve  in
maintaining environmental quality as well  as  the relative
impacts that various stressors have on these roles.

*•  Detenbeck  and  coworkers found the  effects  of
   physical disturbances on urban wetland water quality
   to be related to characteristics of the wetland as well
   as to the surrounding land use (Detenbeck "Urban
   wetlands"; Detenbeck "Prevention, minimization, and
   monitoring"; Detenbeck et al.).

*  A study of Great Lakes coastal wetlands  by  Brazner
   and  Magnuson found that a combination  of  regional
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  factors (turbidity) and local factors (degree of human
  development)   influenced  the  patterns  of  fish
  distribution that can be important to the health of fish
  communities in the Great Lakes. Stable isotopes were
  found  to be useful for characterizing food webs in
  these types of systems (Keough et al.).

Other physical and chemical characteristics are important
in  aquatic  ecosystems  because of their impact on  the
hydrologic regime of watersheds.  For example, improved
knowledge on the extent and impact of extreme hydrologic
events can reduce uncertainties in assessing the  risk of
chemical   contaminants.   The   development   and
implementation of a modeling approach provides the means
to establish a holistic perspective of a watershed response,
which then facilitates the integration of regulatory programs
to ensure that the most effective and efficient  resource
management options are made available  to  responsible
parties.

*• Evaluation of a model developed as part of a study of
  PCB transport from the Fox River (Wisconsin) found
  that large storm  events  are  predicted to cause
  significant PCB resuspension from sediments with
  subsequent export to Green  Bay, Lake Michigan
  (Velleux et al.).
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Table 26. MED Issues and Accomplishments Overview
 Mechanisms of Toxicity
  Issue
                     •m
  How can an understanding of the relationship
  of chemical structure and properties to
  mechanisms of toxic action and xenobiotic
  metabolism be advanced?
    Classified a diverse set of industrial chemicals into several classes of narcotics and oxidative
    phosphorylation uncouplers using the method of joint acute toxicity of binary chemical
    mixtures.
    Addressed approaches to predicting stability and formation of reactive intermediates that can
    be associated with electrophile reactivity and oxidative stress.
    Described relationships between electronic structure of chemicals and their photoinduced
    toxicity, and described method of identifying "phototoxic" PAHs.
  Issue
  How can interspecies extrapolation
  techniques be advanced?
•   Developed a predictive technique for visualizing the output of toxicokinetic models that
    provides a rapid and easily understood representation of complex results.
•   Evaluated the uptake and elimination of 2,3,7,8 - TCDD in medaka (small fish species),
    revealing a much higher-than-expected bioconcentration factor from water to fish tissue.
•   Modeled the uptake, distribution, and elimination of PCBs in tree swallows and used a
    bioenergetics approach to evaluate uncertainties in using this species as a bioindicator of
    effects in higher trophic levels.
  Reproductive and Developmental Toxicology
 Issue
MED Accomplishment
  How can an understanding of scope and
  nature of chemically mediated impacts on
  reproduction and development be advanced?
    Determined that 2,3,7,8 - TCDD effects on early life stage development and survival of lake
    trout via various routes were dose-related, with little difference in response, based on
    different exposure routes.
    Demonstrated that effects of diflubenzuron on bluegill sunfish were caused by a reduction of
    their preferred food source rather than by direct toxicity.
 Chemical  Mixtures and Multiple Stressors
  Issue
  How can current toxicity assessment methods
  for contaminated sediments be validated?
    Compared species sensitivity of benthic organisms.
    Evaluated the equilibrium partitioning method of predicting responses based on water
    concentrations.
    Provided a general review of available sediment test methods.
  How can an understanding of sediment
  contaminant bioavailability be advanced?
    Developed and evaluated methods for measuring contaminants in sediment interstitial water.
    Evaluated the role of acid volatile sulfide (AVS) in binding with metals in sediments.
  How can the potential effects of wastewater
  discharge be interpreted?
    Developed and evaluated a method to screen for the presence of chemicals that
    bioaccumulate in freshwater organisms.
  How can understanding of the interactive
  effects of PCBs, dioxins, and furans be
  advanced?
    Developed toxic equivalency factors (TEFs) for congeners of polychlorinated dibenzodioxins,
    furans, and PCBs based on their in vivo effect on rainbow trout and compared the values to
    those developed for mammals.
  How can methods be improved to identify
  and quantify agents in toxic agents in complex
  chemical mixtures?
    Developed toxicity identification evaluation (TIE) procedure to implicate specific contaminants
    as causative toxicants.
  How can an understanding of interactions
  between toxic chemicals and physical and
  chemical properties of the aquatic
  environment be advanced?
    Found that toxicity of some aromatic hydrocarbons was increased by the presence of sunlight.
    Found that toxicity of total ammonia to a freshwater amphipod (Hyalella ozteco) in soft water
    was not influenced by pH.
    Found that while many parameters reduced toxicity of copper, these effects were not solely a
    function of copper speciation, as is often cited.
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Issue
How can the understanding of ecosystem
organization and dynamics, and time and
spatial scales advance the means to predict
aquatic system responses with laboratory
data?
MED Accomplishment
• Presented and discussed some of the limitations in extrapolating four laboratory-based
sediment assessment techniques to the field.
* Related fate and distribution of chemicals to effects on ecosystem in study of two pesticides in
an enclosed freshwater ecosystem.
• Presented a method for determining thermal requirements of freshwater fish. Used method
to evaluate potential effects of global climate change on distribution of 57 species.
* Developed and validated a model that simulates fish habitats in lakes and streams, as defined
by temperature and dissolved oxygen concentrations.
Watershed Characterization
Issue
How can understanding the role of wetlands
in environmental quality maintenance be
advanced?
How can knowledge of the extent and impact
of extreme hydrologic events be used to help
interpret and predict the movement of
chemical stressors?
MED Accomplishment
• Found physical disturbances on wetland water quality to be related to characteristics of the
wetland and to surrounding land use.
• Found that a combination of regional and local factors influenced patterns of fish distribution
that can be important to the health of Great Lakes fish communities.
* Found that large storm events are predicted to cause significant PCB resuspension from
sediments of the Fox River with subsequent export to Green Bay, in Lake Michigan.
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Important Scientific  Issues
Terrestrial vegetation	
    Terrestrial vegetation provides the
    basic  energy  and structure for
terrestrial ecosystems, as well as serving
as our primary source of food, fiber, and
wood products.  In the past, we  have
considered vegetation to  be an easily
regenerated natural resource that was
relatively insensitive to environmental
stress. However, our understanding and
concern for this basic component of the
biosphere is changing. There is increas-
ing concern over large-scale degradation
and loss of biotic diversity in terrestrial
ecosystems, owing partly to factors such
as:

• Regional-scale air pollution
• Climate change
• Large scale displacement of natural
  terrestrial ecosystems
• Potential wide  spread  use  of  new
  generations  of  highly  phytotoxic
  chemicals

Regional/landscape view
The focus is changing from the study of
relatively small, individual environmental
units, which were assumed to represent
"typical" classes of ecological systems, to
a closer consideration of the regional/
landscape ecology. Many key ecological
functions occur at interfaces or margins
between different types of ecosystems -
not just within a system. Some examples
include biological, nutrient, and energy
interchanges  between  estuaries   and
their inland watersheds; between  wet-
lands and their surrounding uplands; and
within   riparian    (riverbank)   zones
surrounding lakes  and  streams.  In
addition, at larger spatial scales, the
variation  of  responses   within  an
ecological  unit  can be more important
for risk assessment than  the  average
response  of a "typical" system.  The
question posed to scientists is often not
"how does a typical lake respond?" but
"which  lakes  are most sensitive?" or
"which watersheds offer  the greatest
potential for wetland restoration?" Even
site-specific decisions, such as permis-
sible daily loadings for widely distributed
water  pollutants  such  as sediments,
require a  landscape or regional scale
understanding  in order to determine
that action at a particular site will benefit
the watershed or ecosystem as a whole.

Issues   	..   ;.. . ;"•
Some of today's most important national
concerns also focus on larger and more
complex  ecological issues,  such as
regional acidification  of lakes in the
Adirondacks,  nutrient  enrichment of
eastern coastal waters, viability of widely
distributed species such as the Northern
Spotted Owl,  deterioration of major
waterfowl  nurturing grounds areas (e.g.,
the Prairie Pothole region),  loss of
biological diversity in the Everglades, etc.
In addition, some of the major social and
economic concerns of the WED region
include the old  growth  forest  and
salmon declines in the Pacific northwest,
massive alteration of the coastal and
inland  waters  of California,  and the
ever-increasing    conflict    among
competing uses of natural resources in
the intermountain west.  All  of these
   Western

    Ecology

    Division

      The Western Ecology
Division (WED) is responsible
     for providing EPA with
national scientific leadership
  in terrestrial/plant ecology
    and regional/landscape
      ecology, as well as a
      geographic focus on
 reducing uncertainty in the
  assessment of risks to the
  ecological resources of the
  western United States and
          the Pacific coast.
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issues  go well beyond the boundaries of individual
ecosystem types and  involve  geographic  mosaics of
ecosystems or clusters of similar ecosystems.

Uncertainties	.
Issues on a larger scale include questions that highlight
the uncertainties in  assessing  environmental risks to
vegetation at individual and regional levels.  Experience
with the National Acid Precipitation Assessment Program
has shown that measuring and predicting the impact of
environmental stresses on  vegetative systems is full of
uncertainty.  For example, plant responses to stress are
quite variable  because  of their high degree of genetic
variation and wide range of physiological responses to
environmental conditions.  It cannot be  assumed that
plants will behave the same under controlled conditions
as in the field. In addition, the long lifespan of some
species, such as trees, tends to mask early expression of
environmental  stress   and  make  the  cumulative
interactions among multiple stresses more important.
Minor changes in competitive stresses can cause major
shifts in the species composition of vegetative systems.
The timing or  sequence of extreme  or intermittent
events such as  droughts may have greater impact on
vegetation than average conditions.  Natural  cycles of
vegetative destruction (fire, pestilence, senescence, etc.)
and   regeneration  are  hard  to  distinguish  from
anthropogenic effects.

Scientific questions that derive from these uncertainties
are the  target  of WED's research efforts.  National
scientific responsibilities combine with its geographical
focus to address these major questions that underlie the
protection,  use,  and  restoration  of the  ecological
resources of the  nation's West, including the Pacific
coast.

Refer to Table 27.  Issues and Accomplishments Overview,
for a quick look at some of the major accomplishments
of Fiscal Year 1995.
FY 1995 Accomplishments
The following pages present a few of WED's accomplishments that address areas of uncertainty as they relate to
important national and regional issues.
       Ozone Considerations
Consideration of the effects of ozone  on terrestrial
systems includes issues of stratospheric ozone depletion
(with resultant increases in UV-B) as well as the effects of
increased tropospheric ozone (the most widespread air
pollutant affecting vegetation in the US). WED scientists
have addressed uncertainties in several ozone related
areas by advancing the knowledge of previous research.

Previous greenhouse and growth chamber studies have
shown that UV-B has significant effects on rice, the world's
most important crop species. In FY95 the  culmination of
extensive research on the effects of climate change and
enhanced  UV-B  radiation  addressed  some  of  the
uncertainties that exist in the laboratory findings.

*• WED scientists (Olszyk et al.; Olszyk) showed that
  enhanced UV-B had no consistent effects on rice yield
  under field  conditions.  The  plants may  be  less
  susceptible to UV-B in the field because of the higher
  UV-A to UV-B ratios that stimulate cell repair. This
  finding suggests that increased UV-B does not pose a
  major risk to rice production.

Oceanic phytoplankton are  at the base of the oceanic food
chain and are  particularly exposed  to  UV-B radiation
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because of their surface  zone habitat.  Previous studies
(mostly  conducted  in  laboratory  conditions   using
photosynthesis or carbon fixation as an indicator of effects)
have shown that UV-B affects phytoplankton.

* To  assess  maximum  UV-B impacts under field
  conditions, shipboard  experiments were  conducted
  using Antarctic phytoplankton during the period of the
  ozone hole (Sigleo and Neale, Sikorski et at.). Results
  indicate that the increased  UV-B  alters  pigment
  composition,    as   expected   from   laboratory
  observations. However, because the effect is mitigated
  by cloud cover and mixing of the phytoplankton in the
  water column, direct application of lab dose responses
  to the Antarctic may overestimate the actual effect.'
  The results also show that the primary degradation
  product of chlorophyll constitutes up to 50% of the
  chlorophyll at  the end of a phytoplankton bloom.
  Because this degradation product has a similar spectral
  signature  to  chlorophyll,  remote  sensing  may
  substantially overestimate production, especially at the
  end of blooms.

+ WED scientists (Behrenfeld et al.) tested the effects of
  UV-B   on  nitrate  and  ammonium  uptake  by
  phytoplankton. UV-B inhibited uptake of both nitrogen
  compounds. Because  of the specific wavelengths
  having the effect, reductions in ammonium uptake will
  occur deeper in the water column than reductions in
  carbon fixation. Therefore,  ecological  assessments
  based solely on  short-term  reductions  in  carbon
  fixation may underestimate the extent of damage to
  phytoplankton.

Tropospheric  ozone  also has profound  effects  on the
rhizosphere, but unlike  carbon dioxide, it depresses root
growth and mycorrhizal activity.

*• Scientists at WED used a unique culturing system to
  quantify carbon movement in plant systems, including
  roots and mycorrhizal fungi,  in order to understand
  better the  mechanisms  of  ozone  effects on the
  rhizosphere  (Andersen  and Rygiewicz; Rygiewicz,
  Martin, et al.; Wilson  et al.). Tropospheric ozone was
  found to alter the movement of carbohydrates in
  plants, often reducing the amount of carbohydrate that
  is allocated to  roots and mycorrhizae.  As a result,
  seedlings were more susceptible  to nutrient and
  moisture  stress.   By   adversely   affecting   the
  rhizosphere, ozone impacts on forest ecosystems may
  be more widespread than previously noted based on
  foliage damage. Moreover, ozone stress may magnify
  the  effects  of predicted higher  temperatures and
  regional  drought (due to global climate change).
         Risk Assessment issues
WED scientists continue to advance knowledge in areas
that will reduce  uncertainties regarding the ability to
extrapolate experimental findings to real life situations.
They have done this by providing data where gaps exist
and by developing and improving modeling and analysis
methods and indicators.

Uncertainties resulting from spatial variation  in climate,
soils,  and topography are significant factors limiting our
ability to  extrapolate  experimental findings to real life
situations  and consequently,  to  predict  environmental
impacts at regional scales. Distributed models of physical
and ecological processes are  becoming widely used in
ecological  research and assessments to account for this
spatial variation.  These models often require data to be
interpolated from irregularly scattered measurement sites,
such as weather stations.  Interpolation introduces spatially
varying errors that are compounded in model simulations.
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NHEERL FY95 ANNUAL REPORT
WESTERN ECOLOGY DIVISION
*• WED scientists used spatial analysis techniques to
  develop  a method for characterizing the  risk of
  tropospheric ozone to regional vegetation in the U.S.
  (Hogsett et al. "Ecosystem exposure assessment").
  Although ozone is the most widespread air pollutant
  that affects U.S. vegetation, its effects on forests vary
  regionally. This variation is the result of differences in
  wind  patterns that carry ozone from urban areas,
  differential sensitivity of plant species, and differences
  in climate and soil conditions.  WED scientists also
  developed    a  Geographic  Information   System
  (GlS)-based technique that combined experimentally
  derived response functions and regional environmental
  and weather data to simulate long-term growth effects
  at a regional scale.

* WED scientists applied spatial analysis techniques to
  characterize  the  risk of global climate  change to
  forests and forest products. They combined regional
  vegetation models and predicted human use of forest
  resources to identify regions and  timber products that
  are vulnerable to global climate  change (Cairns et al.
  "Forests of Mexico"; Cairns et al. "Carbon dynamics";
  Brown, Lennart et al.; Mo et al; Solomon, numerous
  works; Silver et al. "Biodiversity and biogeochemical";
  Brown).  Much of this research was conducted in
  support of the Intergovernmental  Panel on Climate
  Change.

Most contaminants that are released into aquatic habitats
eventually accumulate  in sediments  where  they can
adversely affect benthic ecosystems and/or enter aquatic or
human food chains.   Sediments  can contain hundreds of
contaminants, but most risk assessments are based only on
the effects of single chemicals.

* WED scientists (Swartz et al.) developed and tested
  the "IPAH Model" that predicts the probability of
  mortality  for mixtures  of  polynuclear aromatic
  hydrocarbons by  integrating models for equilibrium
  partitioning,  QSAR,  and toxicity.  Comparisons of
  model predictions with observed toxicity in the field
  showed over 86% correspondence. The model can be
  expanded to include other neutral narcotic pollutants.
*• WED scientists tested the accuracy of an equilibrium
  model  that  is  widely  used  by  EPA  to  predict
  bioaccumulation  of sediment-associated  PCBs and
  other neutral organics (Boese et al.). This model has
  been criticized because it lacks  an established degree
  of uncertainty in its predictions.  Test results indicated
  that, while the  model  would underestimate the
  bioaccumulation  of  certain   PCB cogeners,  the
  differences between  observed and predicted tissue
  residues were within the range used by the agency and
  that the model was sufficiently .accurate for agency
  use.

Large-scale patterns in the  distribution of habitat (e.g.,
fragmentation) are widely believed to be important for
maintenance of regional biodiversity.  However, evidence
for  these  assumptions is lacking.   Scientifically sound
techniques to deal effectively with regional scale ecological
resource  questions  are still  in their  early  stages  of
development.

* WED  scientists examined  patterns  and effects  of
  wetland loss and degradation  in  rapidly urbanizing
  areas to determine how wetland management impacts
  wetland function.   By using landscape scale analysis,
  they showed that incremental loss of small, individual
  wetlands caused a disproportionately  large loss of
  area-wide plant diversity. (Holland et al.)

Delineating geographic areas of ecological similarity based
on multiple landscape characteristics has become a powerful
tool for evaluating patterns of regional ecological response
and for extrapolating observations from individual sites to
regional scales.

* Continuing   the   refinement  and   application  of
  techniques for defining ecoregions at multiple scales
  ("Omernik ecoregions"),  WED  scientists developed a
  classification  for the western corn belt.  This work
  advances  the   scientific  basis   for  establishing
  environmental management goals such as water quality
  standards. (Griffith  et al.).
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                                                                       ADVANCING KNOWLEDGE FOR A PURPOSE

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                                                                                 NHEERL FY95 ANNUAL REPORT
                                                                                  WESTERN ECOLOGY DIVISION
Over  two-thirds  of the carbon in forest ecosystems is
estimated to be  in soils and peat deposits.  Despite the
importance of forest soils in the global carbon cycle, our
understanding of carbon movement and sequestration in
soils is severely limited.

* WED  scientists were among the first  to measure
  carbon flux  directly through  all  major pools of a
  mycorrhizal-coniferous tree system  (Andersen  and
  Rygiewicz;  Rygiewicz and Ingham;  Rygiewicz  and
  Andersen). They found that mycorrhizal associations
  (symbiotic associations of fungal mycelium with roots
  of a higher plant) have a profound effect on the cycling
  rate and size of forest carbon pools. The implications
  are that  if mycorrhizal  colonization in  forests is
  affected by global climate change, the role of forests in
  the global carbon cycle could be altered world-wide.
  At   regional    scales,   air   pollutants-particularly
  tropospheric  ozone-could  also  alter  rhizosphere
  processes to the detriment of forest health.

Detection of trends in environmental conditions is critical for
effective  environmental management both  in terms of
evaluating the management decisions and  in detecting
problems before they become widespread. To detect trends
it is necessary to develop and test indicators of ecological
condition.

+ Separating natural and induced variability of indicators
  is a major scientific uncertainty in detecting trends.
  Research  by WED scientists identified a framework for
  evaluating both natural and introduced variability and
  their impact on trend detection.  The results show
  that the dominant forms of variability with which most
  ecologists are  familiar can be dealt with in a statistically
  rigorous way  and do not prevent  us from  effectively
  detecting regional ecological trends. (Larsen, et al.)

*• Separating natural  phenomena from anthropogenic
  perturbations to ecological systems has always been a
  challenge. Research by WED scientists demonstrates
  that regional  surveys using biological indicators can
  detect and identify some types of natural events that
  have very  subtle  ecological  impacts.    Ecological
  condition indicators showed evidence of the impact of
  the   1991   Mt.  Pinatubo  volcanic  eruption  on
  temperature and zooplankton species richness in lakes
  of the northeastern U.S. (Stemberger et al.)

Forests, grasslands, and agricultural fields are exposed to
increasing  levels  of anthropogenic stressors acting in
combination with each other. It is not enough to establish
dose-response data for specific stressors and apply them
in an additive fashion to assess risk to vegetation.  In
order to predict responses to multiple stressors, we
need a  mechanistic  understanding  of how species
interactions and ecosystem functioning are affected by
multiple stressors.

During fiscal year 1995, WED scientists addressed multiple
stress effects on vegetation associated with global climate
change,  elevated  atmospheric  carbon  dioxide,   and
tropospheric ozone.  Much of this work focused on the
rhizosphere (root zone of the soil), because  many  of the
processes controlling vegetation response originate there.

*• To determine the sensitivity of major vegetation types
  to climate change, WED  scientists developed,  and
  applied for the first time, "transient" models of global
  vegetation redistribution (Solomon "Maximum natural
  migration rates"; Solomon and Kirilenko; Bugmann and
  Solomon). These models simulated the lags associated
  with forest  dieback, migration, and regrowth as the
  earth's climate  changes,  revealing that over the next
  100  years,  increasing amounts of carbon could be
  added to the atmosphere from accelerated changes in
  the distribution of global vegetation.  Redistribution
  will  likely be driven by forest  dieback and wildfires.
  While large-scale effects may take decades to become
  visible, perhaps the most  significant mechanism for
  carbon release may be taking place in  the near-term
  changes  in the rhizosphere.

Sulfonylurea (SU)  compounds  represent a new family of
chemical herbicides that work at extremely low application
rates and are rapidly replacing traditional chemicals such as
ADVANCING KNOWLEDGE FOR A PURPOSE
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 NHEERL FY95 ANNUAL REPORT

 WESTERN ECOLOGY DIVISION
atrazine and 2,4-D in major agricultural areas of the U.S.
While safer for humans, these chemicals are extremely toxic
to vegetation.   Major concerns have  arisen over their
potential effects on nontarget plants, both agricultural crops
and indigenous species.

* WED  scientists conducted research to  determine
  vegetation effects of low levels  of  SU  herbicides
  (Fletcher et al. "Chlorsulfuron influence";  Fletcher et
  al. "Low levels of chlorsulfuron") finding that a single
  application  of the SU herbicide "Glean" to  cherry
  trees, at I/100 of recommended field application rate,
  caused a significant reduction in fruit production while
  having no effect on leaves. Further experimentation
  showed that SU herbicides had similar effects on a
  range of annual plants, but that traditional herbicides
  applied at the same rates had no adverse reproductive
  effects.
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                                                                             NHEERL FY9S ANNUAL REPORT
                                                                              WESTERN ECOLOGY DIVISION
 Table 2 7. WED Issues and Accomplishments Overview
OZONE CONSIDERATIONS

issue
Does elevated UV-B radiation, caused by ozone
depletion, adversely affect rice production?
How can laboratory studies of UV radiation effects
on phytoplankton be extrapolated to assess UV
impact under field conditions?
What are effects of tropospheric ozone on the
rhizosphere?
RISK ASSESSMENT ISSUES

issue
How can experimental findings based on spatial
variation in climate, soils, and topography be
extrapolated to real-life situations?
How can risk assessments based on single-chemical
effects, be extrapolated to sediments that can
contain hundreds of contaminants?
How do patterns in distribution of habitat affect
regional biodiversity?
How can multiple landscape characteristics be used
to evaluate patterns of ecological response?
How can understanding of carbon movement and
sequestration in soil be increased?
What indicators of ecological condition can be
developed to detect problems before they become
widespread?
How are species interactions and ecosystem
functioning affected by multiple stressors?
What are the potential effects of Sulfonylurea
compounds on none-target plants?


•;• *F«iftf,;jf»wwfi'i,f|»iia>f,wif jw»ll*s» - - - . ",-"•:",•,
• Showed that increased UV-B had no consistent effect on rice production under field
conditions.
• Assessed UV-B impacts on Antarctic phytoplankton during the period of the ozone
hole.
• Tested effects of UV-B radiation on nitrate & ammonium uptake by phytoplankton.
• By quantifying carbon movement via a unique culturing system, showed that troposhere
ozone reduces the amount of carbohydrate allocated to roots and mycorrhizae and
thus makes seedlings more susceptible to nutrient and moisture stress.

l/t^iSM^'V*; ^3 ''' si^'« *~\^"^*S /'- '" .' .. " '•*••' • \
'wVKlnt A Jfc?&L»****iiMM*feitmMi'tt .
WtUACCOrnpllSIvM Vents
• Developed method for characterizing risk of tropospheric ozone to regional vegetation
in the U.S.
• Characterized risk of global climate change to forests and forest production.
• Developed/tested "ZPAH Model" that allows for assessment of mixtures of polynuclear
aromatic hydrocarbons.
* Validated accuracy range of a widely-used equilibrium model to predict
bioaccummulation of PCBs associated with sediment.
• Demonstrated use of landscape scale analysis to show regional loss of plant diversity.
• Developed a classification system for the western corn belt.
• By measuring carbon flux through all major pools of a mycorrhizal-coniferous tree
system, determined that mycorrhizal associations have a profound effect on the cycling
rate of forest carbon pools.
• Identified a framework for evaluating natural and induced variability and their impact on
trend detection.
• Demonstrated that regional surveys using biological indicators can detect & identify
some types of natural events.
• Developed and applied novel "transient" models of global vegetation redistribution to
determine multiple stress effects of global climate change and other factors.
How are species interactions and ecosystem functioning affected by multiple
stressors?
• Determined adverse reproductive effects of low level of Sulfonylurea herbicides on a
range of annual plants.
ADVANCING KNOWLEDGE FOR A PURPOSE
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                                                                                      NHEERL FY95 ANNUAL REPORT
                                                                                                 HEALTH DIVISIONS
Overview of NHEERL Health  Divisions
     There are five health  research divi-
     sions,   all   located  in  Research
Triangle Park, NC. Each division has a
  Table 28. Health Divisions Overview
                      particular focus, as described in  Table
                      28. Health Divisions Overview.
   Reproductive
   Toxicology
   Division
   Environmental
   Carcinogenesis
   Division
   Experimental
   Toxicology
   Division
   Human Studies
   Division
   Neu rotoxrcology
   Division
Performs research on the effects of environmental pollutants on
reproduction and development.
Develops biological indices for assessing damage (including germ cell
physiology, morphology, and function), reproductive function,
endocrine function related to reproduction, and teratogenesis.
Major research emphasis on the development of new and improved
methodologies and models for the assessment of male and female
reproductive toxicity, embryo and fetal toxicity, and postnatal
functional deficits.

Performs research on mutagenesis, Carcinogenesis, and related studies
in cellular toxicology including:
•  Evaluation of the mutagenic and oncogenic potential of agents of
   environmental concern. Includes evaluation of pure chemicals and complex
   environmental mixtures through incremental application of bioassay
   methodologies
•  Development of improved risk assessment procedures
*  Application of biomarkers to environmental  health studies
•  Application of structure activity methods (SAR) to environmental toxicology

Performs research to determine the health effects of inhaled
environmental pollutants, and cause and effects relationships at
pollutant concentrations that mimic those occurring in the
environment.
Intense investigations center on the pulmonary and cardiovascular
systems, the immune system, host defense mechanisms against
infectious and neoplastic disease, and other extrapulmonary systems
that are also susceptible to inhaled pollutants.

Conducts clinical and epidemidogJcat tnvestSgatfons to improve the
understanding of human health risks associated with environmental
                     animals or in vitro systems.
                     pulmonary,
                     other divisions.
means to enable the prediction of whether & environmental agent
will produce neurotoxicity in humans. Human neurotoxic disease is
modeled in laboratory animals, and data are collected in animals to
make predictions about possible neurotoxic risks in humans. Studies
range from the whole organism to the molecular level and include
neurobehavioral, neurochemtcal, neurophysiological, and
neuroanatomicaf approaches.
         Health

  Divisions


   The NHEERL health effects

     research program is the

     responsibility of the five

        health divisions. The

   accomplishments of these

divisions reflect their support

      of the risk assessment

      paradigm. This section

  provides a brief description

      of the divisions and an

   overview of the important

          areas of focus and

     coordination within the

            health program.
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 NHEERL FY95 ANNUAL REPORT
 HEALTH DIVISIONS
NHEERL  is recognized  for  its  interdivisional, multi-
disciplinary approach to many research situations. The
unique expertise  and  facilities at NHEERL provide an
excellent opportunity for a three-pronged approach to
studying environmental health problems, encompassing
the following:
I.   In vivo and in vitro laboratory studies
2.   Clinical  investigations (e.g.,  controlled  human
    exposures)
3.   Epidemiological research

As an example, much of our understanding of respiratory
risks associated with ambient air pollution is the result of
application of this multidisciplinary approach. A variation
of this approach has been applied in each health division
and has resulted in improvements in animal-to-human
extrapolations (the "parallelogram" approach).
Research Framework	
NHEERL health research is structured around the risk
assessment paradigm as applied in two ways.   First,
research is conducted to address the generic data gaps
and limitations  associated with various components of
the paradigm  (e.g., hazard identification,  and dose-
response assessment) and, as such, improve the overall
application of each of these components, irrespective of
the class of pollutants being addressed. Second, scientists
in NHEERL also apply the risk assessment paradigm in an
analytical manner to specific environmental problems of
high   EPA  priority.   This analysis  delineates  the
component(s) for which the greatest uncertainties/data
gaps exist  and  allows research to  be prioritized and
implemented accordingly.

The divisional reports will summarize the development
of a variety of  methods, models and pollutant-specific
data that reflect progress in  addressing both generic and
problem-specific risk  assessment  questions. Themes
repeatedly emphasized include the following:
Hazard Identification
Hazard identification research is directed toward the
following areas:

• Developing  of better  methods  for  identifying and
  detecting adverse health affects
• Validating predictive biomarkers of adverse effects
• Better characterizing of the relationship of adverse
  health effects to injury and  disease (including the "at
  risk" or most susceptible populations).
• Validating in vitro models and SAR approaches  for
  toxicity screening and identifying putative mechanisms
  of toxicity
Dose-Response Assessment
Dose-response  research investigates  the nature of
normal, injured, or diseased processes. Information from
this  research  allows  for  the derivation  of more
biologically based dose-response (BBDR) models that are
more relevant for quantifying  human risk. Use of these
models reduces uncertainty in the assumptions that are
applied in the risk assessment  process.

Pharmacokinetic data and models are important in BBDR
modeling  because they  delineate  the  processes and
factors that   determine  pollutant uptake and  the
relationship between  applied  dose, target dose, and
target organ toxicity. Insights such as these often provide
a starting point for quantifying uncertainty between
species to species, route to route.and high to low dose
extrapolations.

Models of Environmentally-Related Diseases
For various problem areas investigated by the health
divisions, the transition from the hazard identification to
the dose-response assessment research has also been
accompanied by development of models for environ-
mentally-related  diseases such as  cancer,  respiratory
allergies, neurodegenerative disease, and endometriosis.
In a similar manner, efforts have increased to better
identify, characterize and understand especially suscepti-
ble   populations   including   asthmatics,   immuno-
compromised  individuals, children and the elderly.
82
                                                                     ADVANCING KNOWLEDGE FOR A PURPOSE

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                                                                           NHEERL FY95 ANNUAL REPORT
                                                               ENVIRONMENTAL CARCINOGENESIS DIVISION
Important Scientific Issues
    ECD research  is  directed toward
    developing methods for detecting
cancer-causing agents (carcinogens) and
understanding the mechanisms of envi-
ronmental carcinogens.

EPA carcinogenesis research  is  con-
ducted within the Environmental Carcin-
ogenesis  Division  (ECD) of NHEERL.
ECD focuses its research program on
issues, assumptions, and uncertainties in
cancer risk  assessment. Advances  in
ECD's areas of research will improve
the risk assessment process and provide
a   better  scientific  foundation  for
decisions regarding potential environ-
mental carcinogens.

The division's research program includes
the following components:
• Evaluating the oncogenic potential of
  environmental  agents important to
  regulatory offices
• Performing  definitive studies on the
  activation and detoxification of those
  agents
• Improving  models  used  in  risk
  assessment
• Developing and applying biomarkers
  to health studies
• Developing and validating molecular
  techniques and short-term tests for
  evaluating carcinogenic potential
• Developing      structure-activity
  relationships  (SAR)  for predicting
  cancer-causing  potential  and   for
  hypothesis generation
Refer to Table 30. Issues and Accomplish-
ments Overview, for a quick look at some
of the major ECD accomplishments of
Fiscal Year 1995.
 Table 29. ECD Branches
   ECD BRANCH     Focus
   Biochemistry and     Development of mechanistically based dose-response models of
   Pathology Branch     chemical carcinogenesis using computational, chemical, biochemical,
   (BPB)             biological, and pathological endpoints.
  Environmental
 Carcinogenesis
            Division


          The Environmental
  Carcinogenesis Division (ECD)
    conducts mechanistically-
    based research to advance
knowledge of how components
    of environmental pollution
       contribute to increased
    incidence of cancer in the
          human population.
  Genetic and Cellular
  To>tol
  (OCTB)
                    biomarkers that can be used to both human arid :anJma!;s
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 NHEERL FY95 ANNUAL REPORT
 ENVIRONMENTAL CARCINOGENESIS DIVISION
Cancer is currently the second leading cause of death in
the United  States,  with over 500,000 cancer  deaths
predicted annually. E.J. Sondik (NCI) estimates that the
incidence of cancer has increased by 18% since 1973,
even though the "cure rate" for certain cancers has also
increased dramatically during the same period. Research
over the past decade has provided significant evidence to
associate  environmental  factors  with each of  the
multistep   processes  involved   in  cancer.  Cancer
prevention, therefore, concerns limiting human exposure
to environmental substances that induce or promote the
cancer process. EPA's cancer research is primarily a risk
assessment and cancer prevention program and not a
program targeted toward treatment.

The Agency is currently in the process of revising the
Guidelines for conducting cancer risk assessments and for
the presentation of those risk assessments. Scientists in
ECD have had substantive input into the revision of the
Guidelines. Because of advances in the understanding of
the etiology of cancer, the revised approach to cancer
risk assessment involves weighing all  of the available
evidence (e.g., agent's properties, its structure-activity
relationships,  its activities in studies  related  to the
carcinogenic processes, etc.). Thus, hazard identification
and mechanistic studies, like those done  in ECD, are key
in weighing the evidence and determining the likelihood
that a particular chemical or environmental exposure will
be carcinogenic to humans.  The insight gained from
mechanistic studies  provides guidance in generating
further hypotheses for testing and in selecting models to
define the shape of the dose-response curve.

Using  a research team-based  approach,  ECD  has
selected a limited number of specific research problems
and  focused the group's expertise on solving  those
problems.  The ECD research program is structured to
provide  multi-level  input  into  the  risk  assessment
process.  Division research can be used in  both the
hazard assessment and in the dose response evaluations.
The division conducts research that:

• provides  techniques  and  approaches  for  hazard
  assessment, with a particular focus on biomarkers that
  can be used in animal models and in humans,
• provides insight into the mechanisms and activities of
  specific chemicals, and
• allows for the  development  of biologically  based
  models.
In addition to providing  information that helps define
approaches of general utility for the  hazard  and dose
response  assessments,   division  scientists  focus  on
obtaining information on specific chemicals, classes of
chemicals, or specific environmental exposures that are
of high relevancy to the regulatory offices.
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                                                                              NHEERL FY95 ANNUAL REPORT
                                                                  ENVIRONMENTAL CARCINOGENESIS DIVISION
IT 1995 Accomplishments
         Hazard Assessment
As assays are continually being defined, combined, and
improved  by research  efforts,  it is important  that
scientifically sound methods for analyzing and interpreting
these assays are available to  those responsible for risk
assessment, environmental monitoring,  environmental and
resource management, and public  policy. Ongoing  ECD
research is designed to improve one's ability to interpret
data generated using specific assays.

* ECD scientists worked with national and international
  scientists and organizations to  define hazard identi-
  fication strategies, protocols for the conduct of parti-
  cular assays (Clive et al.), approaches to data  analysis
  (Claxton et al.) and interpretation  (Clive et al.), and
  approaches and considerations in the development of
  risk assessment models (Allen et al.; Dearfield et al.).

*• ECD scientists  joined  two   formal  international
  collaborations (involving the Commission  of European
  Communities,  the US  Environmental  Protection
  Agency, and the I PCS) that focused primarily on  how
  bioassay information,  including recently developed
  approaches, can be used for develop new techniques
  to hazard and risk assessment (Allen et al.; Dearfield et
  al.; Gichner et al.; Kanaya et al.; Ma et al.; Sandhu
  "IPCS"; Sandhu "Results").

*• Because animals and cellular systems used in bioassays
  differ  in genetic  characteristics,  metabolism,  and
  lexicological response from humans, it is important to
  clarify both the differences and similarities so  that
  more appropriate extrapolations and decisions can be
  made   when   using  toxicological  bioassays.   By
  incorporating newly developed molecular techniques
  with more conventional techniques, ECD researchers
  continue to gain insight into assay performance and the
  relevancy of specific test system information to the
  etiology of cancer. In particular, significant information
  has  been obtained to improve understanding  and
  interpretation of SAR-based approaches (Lewis-Bevan
  et al.; Richard), bacterial mutation assays (DeMarini et
  al.,  numerous works;  Shelton   et  al.),  in   vitro
  mammalian  mutation  assays  (Clive et  al.),  and
  cytogenetic assays (Afshari et al.; Kligerman and King).
        Biomarkers
ECD  develops, validates, and interprets cancer  bio-
markers of exposure, effect, and susceptibility in order to
detect or predict environmentally induced  cancer in
human populations.

Biomarkers can be used prior to epidemiological efforts to
understand issues such as exposure levels, bioavailability,
and potential effects of known environmental carcinogens.
Biomarkers,  of  course,  can  also be  used  to enhance
epidemiological studies. The division has worked to identify
the structures of environmental carcinogenic polycyclic
aromatic hydrocarbon (PAH)-DNA adducts (biomarkers)
that are formed in rodent tissues and has related these
biomarkers to those identified in human populations.

*  ECD scientists  quantitated time course  and dose
   relationships  in  the formation  and  decay of each
ADVANCING KNOWLEDGE FOR A PURPOSE
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NHEERL FY95 ANNUAL REPORT
ENVIRONMENTAL CARCINOGENESIS DIVISION
  biomarker in exposed rodents and related them to
  tumorigenic potential (Ross et al.).

  ECD   scientists   synthesized   and   chemically
  characterized   DNA  adduct  standards  for  the
  commonly used herbicide alachlor for use in future
  human  biomarker  studies of  pesticide  applicators
  (Newsnow et al. "Synthesis and Characterization").
        Disinfection By»*j>r«»*f»Ci$;:
In order to continue to provide scientific leadership
regarding  safe drinking water, EPA must continue to
advance  the  knowledge  of disinfection by-product
toxicity. ECD has focused on the disinfection by-products
that are known carcinogens, including the chlorinated
acids and  dichloroacetic acid (DCA) in particular. The
following  paragraphs  describe some  of the advances
made by ECD scientists in this area.

*• ECD scientists  performed research to  show that
  chlorinated acids affect intercellular communication (in
  an in vitro cell culture system) (Benane and House).
  This finding suggests that these hepatocarcinogens
  could also function as tumor promoters.

*• ECD scientists performed  molecular analysis of
  mutations induced by DCA in bacteria. This analysis
  revealed that there may be some specificity in the type
  of point  mutations induced (DeMarini  "Dichloro-
  acetic"). Combined with studies on mutations induced
  by DCA in mouse liver tumors, these efforts suggest a
  possible genotoxic role for DCA in the cancer process.

* ECD scientists also found that in vivo  administration of
  DCA suppresses apoptosis in hepatocytes (Snyder et
  al.), thus altering the number of cancer cells at risk.

MX ;s  known  to be a potent microbial mutagen that is
produced during water chlorination.

* ECD  scientists  showed  that MX  induced   gene
  mutations (predominantly of a chromosomal nature)
  Biomarkers  that identify  interspecies  sensitivities
  (sister-chromatid-exchanges)   were   applied   to
  lymphocytes  from   three  species  including man
  (Erexson et al.), thus providing  additional  scientific
  information used in extrapolation models.
  in mammalian cells (in vitro) (Brack et al.). This finding
  strengthens the concern that MX may be a potential
  mutagen/carcinogen  and indicates that  it has the
  capability to  induce  multiple   types  of  genetic
  alterations.

*• In addition to chemical-specific work, research was
  conducted  to  gain   insight   into  the  potential
  mutagenicity  of drinking  water  disinfected  by
  chlorination,   chloramination,   or  ozonation.  An
  evaluation of relative potency and types of mutations
  induced by these complex mixtures was completed
  (DeMarini  "Drinking  Water").  These   molecular
  analyses indicate that much of the mutagenicity of the
  samples could be accounted for by the mutagenicity of
  MX, adding further evidence that MX is of potential
  concern.
PAHs and their derivatives are toxic components of many
environmental   contaminants,   including   combustion
emissions, creosote,  crude  oils,  and  most  petroleum
products.  ECD  research  continues  to  advance  the
information available about PAHs.

*• Quantum mechanical studies of the structures  and
  reactivities of the  diol-epoxides of benzo[c]phen-
  anthrene  were  completed and  published by ECD
  scientists (Lewis-Bevan et al.). For many PAHs, such
  products   may   be   principal  biologically  active
  metabolites.  ECD scientists determined the relative
  ability of dibenze[a,h]anthracene and its metabolites to
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  form adducts and transform cells morphologically in
  vitro (Nesnow et al. "Morphological Transformation").
  ECD researchers also studied a series of environ-
  mentally relevant PAHs, and derived a mechanistic
  linkage between their ability to form DMA adducts,
  mutate oncogenes, and induce tumors in mice.

Chemical Mixtures	,
Environmental exposures are rarely restricted to single
chemicals. Thus, it is imperative that a part of the ECD's
research effort be directed toward understanding and
prioritizing such exposures for human risk evaluation.

A large amount of research has been performed in the areas
of relative potency and complex mixtures using microbial
assays, primarily because of the relative ease of conducting
these experiments.

*• ECD scientists have made modifications and technical
  advances directed toward making large numbers of
  such comparisons possible (Taylor et al.).
                                                     *• Scientists in  ECD have also performed molecular
                                                       analysis of mutations induced by complex mixtures and
                                                       have published results of the attempts to determine
                                                       the  major  mutagenic  chemicals  in  the  mixture
                                                       (DeMarini et al., numerous works). These studies help
                                                       demonstrate the usefulness of molecular mutational
                                                       analysis  in   identifying hazardous  environmental
                                                       mixtures, identifying the active  components, and in
                                                       understanding  the  mechanisms  of   the   active
                                                       components.

                                                     In  addition to  using  microbial  mutagenesis studies to
                                                     understand the potential hazards of exposures to chemical
                                                     mixtures,  ECD  has  made  significant   advances  in
                                                     understanding chemical interactions in in vivo experiments.
                                                     Following, are some of the ECD accomplishments in this
                                                     area:

                                                     + Demonstrated  potentiation  of  2,6-dinitro toluene
                                                       mutagenicity by coal tar creosote in rats (Chadwick et
                                                       al. "Fischer 344 Rats").

                                                     *• Demonstrated that the pesticide atrazine has also been
                                                       shown to increase the mutagenicity of urine from rats
                                                       coexposed to  both the pesticide  and  2,6-dinitro
                                                       toluene (George et al.).
DBI
                                               •     -    •
        Dose Response Assessment (BBDR Models)
ECD studies the chemical, biochemical, molecular, and
biological aspects of environmental carcinogenesis  to
develop mechanistically based, biologically based  dose
response (BBDR) animal cancer dose response models.
Carcinogens vary in how they initiate, alter, and affect the
stages of the cancer process. Because carcinogenesis is a
complex multistage biological  process, chemicals can
increase the incidence of cancer via a variety of separate,
unrelated biochemical mechanisms.
                                                     One of the targets of carcinogens is the genes (DMA)
                                                     that control cell growth. Another target can be the
                                                     biochemical processes that are involved in cell growth,
                                                     cell growth  regulation,  cell  signaling, and cell-to-cell
                                                     communication. Other targets of chemical carcinogens
                                                     may include processes involved in cell toxicity and death,
                                                     alterations in  hormone levels, effects  on  receptors
                                                     involved  in  cell  growth, effects  on  enzymes that
                                                     metabolize carcinogens, effects on the immune system,
                                                     and effects on the cellular repair systems that allow cells
                                                     to repair damage caused by carcinogens. Concomitant
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with the  recognition of these  facts has  been the
realization that the currently used  statistically based
cancer risk  assessment models  (e.g., the  linearized
multistage model) are probably not appropriate for all
types of chemical carcinogens.

DCA	••-  ""•-' -'-Cj'.-^>'';'':-,---••:
In addition to  the studies mentioned earlier, ECD has
focused on DCA and PAH pollutants  for study of BBDR
modeling.

* From these studies, ECD has  found that DCA is a
  hepatocellular carcinogen  in the  male and female
  B6C3FI mouse and in the male F344 rat.

*• This development has led to a BBDR model for DCA
  using mouse tumor  studies.  ECD scientists have
  generated biochemical, immunohistological (Richmond
  et al.), and molecular mechanistic data (Snyder et al.)
  on the progression  of DCA-induced hepatic altered
  foci, hyperplastic nodules, adenomas, and carcinomas.
  Cell growth-cell proliferation (Carter et al.) and cell
  death (apoptosis) parameters (Snyder et al.) were also
  determined.   This   mechanistic  data   will   be
  incorporated with the tumor data into a  multistage
  dose response model for low dose extrapolation. In
  order   to  create   a  BBDR  model  for   DCA
  hepatocarcinogenesis  in  the  rat, ECD scientists
  completed  a  series of studies in the rat with a
  prototype carcinogen (Dragan  et al.,  numerous
  works).
  These studies provide data on cell growth and death
  parameters and genetic alterations that can be applied
  to the DCA rat BBDR model.

PAH	
One of the uncertainties used in the cancer risk assessment
ofPAHs is the assumption that all environmental PAHs are
of equal  potency to benzo[a]pyrene (B[a]P).

* In order to reduce  uncertainty in this  area, ECD
  scientists studied the lung tumorigenic potency of five
  environmental PAHs in mice and found that the PAHs
  ranged in potency from 0.6-1 18 times the activity of
  B[a]P (Nesnow et al. "Mechanistic linkage"; You et al.).

*• ECD  studies of the  linkages between specific lung
  DNA adducts, specific  mutations  in  lung  tumor
  oncogenes, and lung tumorigenic potency induced by
  PAHs have shown that there are direct linkages
  between specific DNA adducts and induced mutations
  in tumor  oncogenes  (Nesnow et  al. "Mechanistic
  Linkage")   for  specific  PAHs.  A  set  of  DNA
  adduct/tumor (dose/response) relationships has been
  developed  for these  five PAHS that can be used in
  their risk assessment (Ross et al.). This work provides
  a  good foundation for  the  understanding of PAH
  carcinogenesis  and  its  application  to   PAH  risk
  assessment.
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                                                                                    ENVIRONMENTAL CARCINOGENESIS DIVISION
  Table 30. LCD Issues and Accomplishments Overview
  Hazard  Assessment
  issue
  How may interpretations of specific
  assay data be improved?
Helped to define national and international strategies and protocols to advance hazard identification,
data interpretation, and risk assessment modeling.

Collaborated with scientists at the national and international level to develop new approaches to
hazard and risk assessment using recent bioassay information.

Performed research to advance understanding and interpretation of structure-activity relationship
(SAR)-based approaches, bacterial mutation assays, in vitro mammalian assays, and cytogenic assays.
  How can advanced knowledge of
  biomarker usage improve the
  detection and prediction of
  environmentally induced cancer in
  humans?
Quantified and related PAY-DMA adducts (biomarkers) in rodent tissue to tumorigenic potential in
terms of time course and dose relationships.
Synthesized and chemically characterized DNA adduct standards for alachlor herbicide.

Advanced knowledge available for extrapolation models (including humans) using interspecies
biomarker (sister-chromatid exchange).
  Specific Chemical Information
  Issue
  What are the cancer-related risks  of
  water disinfection by products?
Demonstrated that chlorinated acids could function as tumor promoters.
Combined molecular analysis of bacterial mutations and mouse liver tumor research (both DCA-
induced) to suggest a possible genotoxic role for DCA in the cancer process.

Showed that DCA suppresses apoptosis in hepatocytes.
  What potential risks are associated
  with the chlorination by-product MX?
Showed that MX induces gene mutations in mammalian cells (in vitro).

Evaluated several complex drinking water disinfection mixtures and found that much of the
mutagenicity of these mixtures was attributable to MX.
  How can the toxic effects of PAHs and
  their derivatives be understood better?
Derived a mechanistic linkage between the ability of PAHs to form DNA adducts, mutate oncogenes,
and induce mice tumors.
  What is the usefulness of molecular
  mutational analysis in determining the
  major mutagenic chemicals in chemical
  mixtures?
Demonstrated usefulness of molecular mutational analysis in identifying hazardous mixtures and their
active components' mechanisms of action.
  How may in vivo experiments advance
  understanding of chemical interactions
  that increase mutagenicity?
Demonstrated potentiation of 2,6-dinitrotoluene by coal tar creosote in rats.
Demonstrated increased mutagenicity in rat urine when were co-exposed to atrazine and 2,6-
dinitrotoluene.
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ENVIRONMENTAL CARCINOGENESIS DIVISION
 Dose Response Assessment
 What may be done to develop
 biologically based dose response
 (BBDR) models for chemical
 carcinogens not suited to statistically
 based risk assessment models?
•  Performed research to provide data on the progression of dichloroacetic acid (DCA)-induced hepatic
   altered foci, hyperplastic nodules, adenomas, and carcinomas as well as growth-cell proliferation and
   apoptosis parameters.
*  Performed studies with a prototype carcinogen that provided data for application to the DCA BBDR
   model in rats.
 How accurate is the assumption that
 all environmental PAHs are equal in
 potency to benzo[a]pyrene (B[a]P)?
•  Determined potency of 5 PAHs, revealing a range from 0.6-118 times the activity of B[a]P.
 Do direct linkages exist between
 specific DMA adducts and induced
 mutations in tumor oncogenes?
•  Demonstrated direct linkage between specific DNA adducts and induced mutations in tumor
   oncogenes and developed a set of adduct/tumor relationships for 5 PAHs for use in their risk
   assessment.
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                                                                      EXPERIMENTAL TOXICOLOGY DIVISION
Important Scientific Issues
    The Experimental Toxicology Divi-
    sion comprises three branches: Pul-
monary Toxicology (PTB), Immunotoxi-
cology (ITB),  and  Pharmacokinetics
(PKB). Each branch works both inde-
pendently and collaboratively, not only
with the other branches in the Division,
but across divisions in NHEERL and with
scientists in other organizations. Refer to
Table  31. ETD Branch Objectives.

Background

PTB:  The   overall  mission  of the
Pulmonary Toxicology  Branch  is to
provide data derived from animal studies
that complement, extend,  and clarify
pulmonary health issues associated with
human exposures  to  pollutants and
toxicants. These issues derive from the
need to understand better the nature of
injury  or  disease processes  and to
establish  a quantitative framework by
which  animal data  can  be used in
assessing human risk.
                           Physiological approaches to pulmonary
                           toxicology involve all levels of biological
                           organization:  morphological,  cellular,
                           biochemical, and molecular. In addition,
                           much  attention is paid  to interactive
                           toxicities, both the effects of mixtures of
                           chemicals  and  results  of combined
                           exposures to environmental pollutants
                           and  altered host conditions, such as
                           concurrent infections. A major focus of
                           this branch has been the development of
                           animal   models  of   lung  disease.
                           Dosimetric  issues  have  also   been
                           addressed both for gases, such as ozone,
                           and  for particles. Recent efforts have
                           focused on development of molecular
                           markers of tissue injury,  the role of
                           endogenous oxidants and antioxidants in
                           tissue  injury,  and  the  development of
                           animal  models  for populations  with
                           special sensitivity. Validation of quantita-
                           tive dosimetric models has also been a
                           high priority.
   Table 31. ETD Branch Objectives
   Branch

   PTB
Major Objectives

•  To investigate the mechanisms of gas and/or particle-induced lung toxicity
•  To develop methods and models to improve extrapolation between animals and
   humans, between acute and chronic exposures, and from high-dose experimental
   scenarios to low-concentration environmentai exposures
              from other institutions
   ITB
              Characterization of irnmunotoxic effects of various chemicals and mixtures
              Examination of the mechanisms responsible for immunotoxidty
              To understand and describe the f*» of chemkate In the bcdy'. =;.,
Experimental

  Toxicology

     Division

 The Experimental Toxicology
     Division (ETD) conducts
     research to improve the
       scientific basis of risk
   assessment for pulmonary
 toxicity and immunotoxidty
   and to facilitate the use of
 pharmacokinetic data in the
  risk assessment process. In
  addition, ETD assesses liver
  and kidney toxicities. In all
 cases, both mechanistic and
   dosimetric information are
                 involved.
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 NHEERL FY95 ANNUAL REPORT
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ITB: The Immunotoxicology Branch conducts research
directed toward detecting and interpreting the effects of
xenobiotics on the immune system. Suppression of the
immune  system increases the risk of  infectious and
neoplastic disease. On the other hand, stimulation of the
immune  system  can result in allergies or autoimmune
disease.  There  is  evidence  that  a number  of
environmental contaminants can  modulate the immune
system as immunosuppressants, allergens, potentiators of
allergy, or inducers of autoimmunity. Approximately one-
third of the population suffer from respiratory allergies,
and a  third of these have asthma. The incidence  of
asthma has increased by 58% since 1970 for reasons that
are  not entirely  clear,   although  changes  in the
environment have been implicated. Over 200 chemicals
in the workplace have been associated with respiratory
hypersensitivity disorders, and 25% of occupational skin
disease is attributed to allergic responses.

Infectious diseases are the most common  illnesses in
man; they affect one out of four people in the U.S. each
year. The direct cost of one  such disease, influenza, is
between 3-5  billion dollars annually,  and infectious
disease accounts for lost work days in the billions. Several
environmental agents, including environmental tobacco
smoke, ozone, and UV radiation, have been shown  to
enhance infections  and/or affect immune  function  in
humans. Animal data suggest that many more agents may
have such effects. The public health and economic impact
of even small increases in infection or allergy could  be
enormous.

Approaches to the ITB objectives (refer to Table 31)
involve the development of host defense models  to
characterize the consequences of immunosuppression
and animal models for allergy and  asthma associated with
exacerbation of  an  immune response.  In addition, the
differential susceptibility of various animal models is being
examined to understand interspecies variability and to
improve our ability to extrapolate from animals to man.
To this  end, comparisons have been  made between
immune responses of humans and rodents following both
in vivo and in vitro exposure to selected immunotoxicants.
The effort to extrapolate from biochemical and cellular
responses to disease states leads to development of viral,
bacterial, parasitic, and allergic disease models in both
rats and mice, and the identification of biomarkers of
immune system dysfunction.

The exquisite sensitivity of the immune system of the
developing organism to  chemical  toxicants has been
examined, and efforts have begun to examine physical
stressors, such as UVB, as well. Experiments have been
initiated to determine the mechanisms of immunotoxicity
for selected agents. In assessing the health risk associated
with  exposure  to pollutants,  toxicokinetic studies
examine the processes and controlling/modulating factors
that determine the uptake of a  pollutant through  the
portal organs, the relationship of the applied dose  and
the dose delivered to target tissues, and the relationship
of delivered dose to target organ toxicity. These issues
include  considerations   of  absorption,  metabolism,
distribution  among organs,  storage  in  tissues,   and
elimination.  Better  understanding  of  these factors is
needed to help reduce the uncertainty in risk assessment
associated  with  various  extrapolations  such as from
species to species, route to route, and low to high dose.

PBK: This group has taken a strongly iterative approach
to  conducting   disposition  and  metabolism studies
involving multiple  routes of exposure (oral, dermal,
inhalation)  that are closely integrated with computer
simulations. The focus has been on prototype classes of
chemicals such  as  the trihalomethanes, metals,  and
dioxins/PCBs. Hazard  identification and  mechanistic
studies have been carried  out on these chemical classes.
Effort has also been directed toward examining issues of
mixtures,  including  effects  of  various vehicles  on
exposure. Interactive toxicity is being modeled to guide
experimental work better. Recent studies are exploring
the  issue  of differences  in  susceptibility  between
individuals as well as between different populations.

The major scientific issues addressed and published in the
past year can be grouped into those addressing hazard
identification,    dose/response   relationships,    and
quantitative models.
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                                                                        EXPERIMENTAL TOXICOLOGY DIVISION
FY 1995  Accomplishments
        Hazard Identification
Based on anecdotal reports of human health impairments
and mortality in laboratory animals resulting from common
exposures to off-gassed carpet-derived vapors, a carefully
designed research  effort  using laboratory animals  was
initiated   to  assess   potential  adverse  effects  from
commercially available carpets.

* This work (Tepper et  al. "Carpet Samples") focused
  on replication  of the  neurological,  irritant,  and
  mortality effects  noted in  the anecdotal reports.
  Collaborative  research by NHEERL and other ORD
  scientists characterized the chemistry and microbial
  emissions from three "problem" carpets. Exposure of
  mice  following a  carefully controlled  experimental
  paradigm identical  to that reported in the press failed
  to reveal any significant  adverse effects. These negative
  results fail to support the anecdotal reports of acute
  toxicity of carpet emissions, but they do not address
  the issue of delayed response  or hypersensitization
  associated with sick building syndrome.

While traditional toxicology focuses on the study of the
effects of exposure to single chemicals, it is clear that most
public exposures  to environmental  contamination involve
complex  chemical mixtures.  Both  pharmacokinetic and
mechanistic approaches are necessary to disentangle the
issue of mixture  toxicology. An example of one such air
pollutant issue of concern regards the conglomeration of
panicles residing in the air we breathe which derives from a
myriad of combustion and natural sources. For example,
mixtures  of metals and organic  matter associated with
particulate matter (PM) are purported to play an important
role in particle toxicity.

* Recent studies have demonstrated that inhalation of
  very small particulate matter (PM 10) is associated with
  enhanced morbidity and mortality. ETD researchers
  have spent a great  deal  of effort developing appropri-
  ate  inhalation exposure systems  for experimental
  studies in rodents, as well as methods to characterize
  the particles to which the animals are being exposed.
  One of the  most  important questions concerning
  particle toxicity is the mechanistic basis for the adverse
  effects. ETD has suggested that the soluble metals on
  the surface of the particles may play a major role in the
  observed  toxicity.  Comparisons of  particles from
  different emission sources have  indicated that those
  with higher  concentrations of  soluble  metals  are
  associated  with greater toxicity (Pritchard  et  al.).
  These particles  appear to generate reactive  oxygen
  species that cause  or exacerbate the lung damage.
  Additionally, this recent work suggests that particulate
  matter  less than l.S^m in diameter carries more
  bioavailable metals and is  more toxic  than larger
  particles which are  less likely to enter the deep lung.
  The idea that active oxygen plays a causative role in
  multiple types  of  toxicity is becoming  generally
  accepted. If the role of reactive oxygen species in lung
  toxicity can be further substantiated, prophylactic use
  and/or  treatment  with antioxidants has  obvious
  potential.

Another type of mixture exposure involves combination
of chemical and biological agents. Most asthmatic attacks
involve an allergic component whereby  a sensitive
individual  is exposed  to an  allergen that triggers  the
classic asthmatic response, bronchoconstriction.

Both  the  incidence and mortality from asthma  have
increased dramatically in the past twenty years, leading to
the suggestion that environmental factors may play  a major
role. Because of the  allergic  nature of most  asthma,
inflammation  is  a key  component of the  response. Dust
mites are a common allergen associated  with asthmatic
attacks. ETD scientists have been able to develop a  rat
model for human allergic asthma  that mimics the pattern of
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 NHEERL FY95 ANNUAL REPORT
 EXPERIMENTAL TOXICOLOGY DIVISION
eosinophilic infiltration of the lungs, mucous secretion, and
hyperreactivity to antigens  leading to constriction of the
airways.

> Using this model, ETD researchers have been able to
  show that rats exposed to NO2, one of the criteria air
  pollutants and an important indoor air contaminant,
  exhibit enhanced asthmatic responses when exposed
  to dust mites (Gilmour et al.). Thus, while exposure to
  NO2 by itself does not trigger an asthmatic attack, co-
  exposure to a common antigen and an air pollutant
  does. Co-exposure to infectious agents and inhaled
  chemicals can also lead to toxicity that would not
  occur with one in the absence of the other.

* ETD scientists have previously  demonstrated  that
  exposure to ozone increases sensitivity to Strepto-
  coccus infection in rats  and mice. This effect occurs
  because of depression of the pulmonary macrophage
  defense system, which allows time for the bacteria to
  form  protective  capsules,  thus  increasing  their
  virulence.   Pulmonary  bacterial  infections  are  a
  common health problem that may be aggravated by
  exposure to inhaled gases.  In fact, phosgene, a highly
  reactive toxic air pollutant, has also been shown to
  enhance sensitivity to bacterial infection  (Selgrade,
  Gilmour et al.). This finding has proved crucial in the
  current   process    of   setting   the   Reference
  Concentration (RfC)  for phosgene.A comparison of
  the effects of ozone on human and mouse pulmonary
  macrophage activity following both in vivo and in vitro
  exposure showed comparable sensitivity between the
  two  species,  suggesting  that  humans,  like  mice
  exposed to ozone and other air pollutants, may be at
  increased risk for bacterial  infection.
          Dose-Response Relationships
To enable scientists to extrapolate data from animals to
humans,  one  must know the target dose to the affected
tissue. Ozone, a polluting oxidant to which  100  million
people are exposed at levels above the  national standard,
has been difficult to study because it rapidly decays once it
touches biological tissue.

* Using a nonradiolabeled isotope for ozone (I8O), ETD
  investigators have devised  methods  of  generating,
  sampling, and analyzing an ozone oxidation product in
  tissues, cells, and fluids from both animals and humans.

>• ETD scientists (Hatch,  Slade et al.) have used this
  species-dependent dosimetry procedure to measure
  the dose of ozone that affects the deep lung in both
  humans and rats. A fourfold higher concentration of
  ozone in air was required to achieve the same tissue
  dose of ozone in rats as in humans.  This discrepancy
  apparently occurs because ozone exposure in clinical
  studies generally involves a certain amount of exercise;
  in  contrast,  rodents are normally sedentary during
  inhalation exposures. In fact, if rats are exercised, the
  dose of ozone in the deep lung dramatically increases.
  These results imply that data generated from rodent
  studies at concentrations higher  than  the  ambient
  ozone concentration are indeed relevant to human
  exposure scenarios, and do not represent excessively
  high levels of exposure.

»• A BBDR  model  developed by Highfill and  Costa
  demonstrates remarkable homology  of  response
  between  humans and animals  over  a  range of
  concentrations and durations. This effect of exercise
  on  deposition of inhaled materials is likely true for
  other gases as well as for particles.

Metabolic constants are key parameters in many PBPK
models.  These  values are based on an  understanding of
biotransformation  and   elimination  pathways  of  the
chemicals that enter the body.
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                                                                               NHEERL FY95 ANNUAL REPORT
                                                                        EXPERIMENTAL TOXICOLOGY DIVISION
*• Using a PBPK model, ETD scientists have discovered
  a novel metabolic pathway involving  conjugation of
  bromodichloromethane,  the   most  carcinogenic
  trihalomethane (THM), with glutathione that leads to
  the generation  of genotoxic metabolites (Gao et al.).
  This pathway has not been detected for chloroform.
  This finding has major implications for comparative
  toxicity and carcinogenicity of several THMs, which
  are key disinfection products of drinking water. It also
  supports the continued use of a linearized multistage
  model for risk assessment for at least some of the
  brominated compounds, while the weight of evidence
  suggests that  a  nonlinear  model  might be  more
  appropriate for a  nongenotoxic chemical  such as
  chloroform.

Arsenic is a natural toxic contaminant of drinking water of
concern mostly in  Western states. The Agency is trying to
determine if it should establish a maximum contaminant
level (MCL) for arsenic in drinking water and, if so, whether
it should be set below the current interim level of 50 ppb.
Because metabolism of arsenic is the key to its toxicity and
carcinogenicity, ETD researchers are exploring the basis for
the methylation of arsenic, which leads to decreased toxicity
compared to the inorganic forms.

* ETD scientists  have  demonstrated that  sulfur-
  containing molecules such as glutathione are required
  for the reduction of arsenic in intact cells and are also
  required for methylation (Styblo et al. "Mono- and
  dimethylation of arsenic"). The critical role of gluta-
  thione in arsenic metabolism has major implications re-
garding the role of diet in arsenic toxicity, because diet
determines the availability of glutathione in the blood-
stream. These studies required the development of
analytical strategies for the characterization of arsenic
metabolites in a variety of biological matrices (Styblo
et al. "Methylated metabolites"). The need to speciate
arsenic in biological samples is currently leading to the
development of a PBPK model for arsenic exposure
which will be linked to a BBDR model with predictive
value for arsenic toxicity.

An intensive study has been aimed at estimating human
body burden of dioxins, dibenzofurans, and  PCBs
(DeVito et al. "Estimated Human Body Burdens").
These chemicals,  for  which  2,3,7,8-tetrachloro-p-
dibenzodioxin (TCDD) is the  prototype, have been
studied extensively in  laboratory animals,  fish, and
wildlife.  Epidemiological  investigations have been
consistent with findings from  animal  studies, which
indicate  that dioxins are carcinogens and  repro-
ductive/developmental    immunotoxicants.   ETD
scientists have explored dose/response relationships to
estimate  relative  potencies  of  major  dioxin-like
congeners in biological specimens. Subchronic studies
at ETD have determined the relative potencies of 12
interacting congeners in  laboratory animals and in
people  from  both   exposed  and  background
populations.  Results   of this  work  have  been
incorporated into EPA's Dioxin  Reassessment  to
calculate the risk posed by levels of dioxin exposure
experienced by the general population.
      Quantitative Models
Structure-activity relationships can be extremely useful for
assessing how chemical structure contributes to toxicity.

*• ETD  scientists have advanced the development of
  quantitative  structure-activity  relationship  (QSAR)
  models for compounds that have the ability to bind to
  steroid hormone receptors. Waller et al have used
advanced computer modeling techniques at ETD to
design a preliminary model that can predict estrogen
receptor binding affinities for structurally related, and,
recently,  diverse     compounds.  Recently,   ETD
researchers have  also  been able to  describe the
structural parameters that underlie  binding to the
androgen receptor. These approaches allow rapid
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  screening  of a large data  set  to predict which
  chemicals may function as endocrine disrupters, by
  helping to  clarify the relationship between chemical
  structure and various possible molecular mechanisms
  of action.

A  key to  developing quantitative  models  to  describe
pharmacokinetic and pharmacodynamic biological processes
is  the specification  of relevant parameters,  such as
organ/tissue weights and volumes, blood flows, chemical
solubility and partitioning properties, metabolic rates, etc.
While  some  of  these  parameters   are  measurable
experimentally or can be taken from the literature, others
must be assumed, based on the best scientific judgment and
the model specifications. Often there are more than twenty
parameters that must be set in a model, so it is critical to
know which are the most important for determining the
model predictions.

»•  ETD scientists have demonstrated the use of sensitivity
   analysis  engineering principles to describe the  most
   important parameters for PBPK modeling (Evans and
   Anderson) of carbon tetrachloride, trichlorethylene,
   and more persistent organochlorines, such as dioxin.
ETD scientists have recently developed sophisticated and
predictive dosimetry  models using a supercomputer.
Inter laboratory studies have been initiated to validate
immunological tests for use in  risk assessment, and a
model to extrapolate from rodent immunotoxicity data
to human health effects has been developed. Interactive
toxicity studies conducted with various VOCs support
the use of the additivity assumption at low doses.
Selected populations  of animals representative of the
elderly and the young have been examined for special
sensitivity to environmental chemicals. A state-of-the-art
exposure system has been developed to measure the in
vivo metabolism of volatile compounds.  Other recent
ETD  studies in the  areas of  pulmonary toxicology,
immunotoxicology, and pharmacokinetics are reflected
in the complete bibliography below.
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  Table 32. ETD Issues and Accomplishments Overview
 Hazard Identification
 Issue
ETDAcconii
 Can anecdotal reports of acute toxicity of carpet
 emissions be supported scientifically?
    Performed mouse exposure experiments in collaboration with other ORD scientists
    that demonstrated no support for reports of acute toxicity of carpet fibers.
 In complex chemical mixtures, what are the
 mechanisms of adverse effects for toxic particulate
 matter (PM) emissions?
    Demonstrated the relationship of soluble metal concentration to toxicity levels in
    emission sources, as well as the greater toxicity level of PM less than 2.5 [lm in
    diameter.
 Do environmental factors play a significant role in
 the dramatic increase in asthma incidences and
 mortality (co-exposure with antigens) and in
 common pulmonary bacterial infections (co-
 exposure with infectious agents)?
 Dose Response Relationships
 Issue
    Developed rat model that demonstrated that co-exposure to NO2 and dust mites
    caused enhanced asthmatic responses, while exposure to NO2 by itself does not trigger
    an asthma attack.

    Demonstrated that phosgene enhances sensitivity to bacterial infection and that ozone
    exposure may also increase risk of bacterial infection.
ETD Accomplishment
 How may the measurement of ozone deposition in
 biological tissue be improved to enhance efforts to
 extrapolate data and develop models for measuring
 ozone effects on humans?
    Developed method using "O to derive data to assess species-dependent dosimetry of
    ozone and trace the product of its oxidant interaction with biological material.

    Using the I8O method, measured dose of ozone that affects deep lung in humans and
    rats and showed fourfold higher sensitivity to ozone in humans compared to rats.

    Demonstrated through mechanistic studies that the difference in rat and human
    sensitivity is due to clinical conditions (exercise during sampling) and that under similar
    conditions remarkable homology of response exists between humans and animals over
    a range of concentrations and durations.
 How may physiologically based pharmacokinetic
 (PBPK) modeling be improved through better
 understanding of metabolic pathways?
    Discovered novel metabolic pathway for bromodichloromethane involving con|ugation
    with glutathione that leads to generation of genotoxic metabolites, thus supporting
    continued use of linearized multistage risk assessment model for some brominated
    compounds.

    Characterized arsenic metabolites in a variety of biological matrices in order to
    demonstrate that sulfur-containing molecules such as glutathione are required for
    reduction of arsenic in intact cells and for methylation, thus providing information
    leading to development of a PBPK model for arsenic exposure.

    Estimated human body burdens of dioxin-like chemicals based on relative potencies in
    subchronic studies in mice.
 Quantitative Models
 Issue
ETP Accomplishment
 What can be done to improve the prediction of
  chemicals that may function as endocrine disruptors
  and to help clarify the chemical structure-molecular
  mechanism relationship of these chemicals?
    Developed a quantitative structure-activity relationship (QSAR) model for compounds
    that can bind to steroid hormone receptors and described structural parameters that
    underlie binding to the androgen receptor, thus providing information to allow rapid
    data set screening.
 In developing quantitative models, how are the most
 relevant parameters specified?
    Demonstrated sensitivity analysis engineering principles to describe the most important
    parameters for PBPK modeling.
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Important Scientific Issues
 A nimal toxicology studies provide the
j\primary means of evaluating the
mammalian toxicity of many environ-
mental pollutants, and provide data for
extrapolation of findings to humans.
However, humans differ  from  most
laboratory animals in  ways that affect
these studies.

•  The inter-individual variation within
   the human species  presents a much
   wider range of response to pollutants
   than is seen in animal studies.
•  Humans have a relatively long life span
   compared to laboratory animals and
   exhibit a high incidence  of chronic
   diseases that are not common in
   laboratory animals.
Some of these chronic diseases, such as
such as asthma, cancer, arteriosclerosis,
and emphysema, present major public
health concerns in the U.S.  Epidemic-
logic studies show that individuals with
preexisting respiratory tract disease
constitute susceptible populations for a
wide variety of airborne ambient and in-
door air pollutants and toxics. There are
over 10 million asthmatics, over 10 mil-
lion chronic bronchitis cases, and several
million patients with emphysema in the
U.S. Next to cardiovascular diseases,
respiratory tract disease exacerbations
are the leading cause  of  noncancer
morbidity and mortality and account for
billions of dollars of medical expense and
lost productivity.

HSD consists of two branches, the
Clinical  Research   Branch  and  the
Epidemiology and Biomarker Branch, to
conduct clinical and  epidemiological
investigations   to    advance   the
understanding of human health  risks
associated with environmental pollution.
The human studies research program
has excellent facilities at the University
of North Carolina, Chapel Hill,  with
state  of the  art  human  exposure
chambers and supporting medical and
scientific     resources.     Through
cooperative  agreements with UNC's
Center for Environmental Medicine and
Lung Biology (CEMLB) and Department
of Epidemiology, HSD  is able to  take
advantage   of  the  school's  critical
complementary expertise.

Table 33. HSD Branches, provides a brief
overview of the two HSD branches.
     Human

     Studies

   Division

The Human Studies Division
 (HSD) performs research to
   provide critical data and
 mechanistic information in
     order to advance the
  scientific basis for human
   health risk assessments,
  including extrapolation of
 animal data to human risk
             estimates.
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 Table 33.  HSD Branches
  Clinical Research Branch
  Primary Functions

  •   Monitor and administer exposures
      on human subjects (under highly
      controlled laboratory settings or
      where the evaluation of effects
      requires complex laboratory
      procedures).
  *   Perform in vitro studies of human
      cells and tissues to advance risk
      assessment resources for human
      study.
Goals
    Determine direct effects of
    pollutants on humans
    Understand basis by which
    pollutants exert their effects
    Understand distribution and
    kinetics of clearance of
    pollutants, especially In the
    human respiratory tract
Methods

Measure the deposition, fate, and biological effects of
inhaled gases and particles; pulmonary and
cardiovascular function; neurobehavioral function; and
pulmonary and systemic immunity and host defenses.
  Epidemiology and Biomarker Branch
  Primary Functions

  Study humans in less rigid, more
  natural settings, using field studies
                              Methods
                             approaches combined with emerging areas of
                                                                .
                                                                                                       '
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IT  1995  Accomplishments
       Sensitive Subpopulatlons (Asthmatics)
Many environmental laws and public health laws explicitly
require that the most sensitive subpopulations  be
protected. Asthmatics are potentially at increased risk for
many inhaled  pollutants,  especially  those that cause
inflammation and cell damage in the airways (e.g., ozone
and particulate pollutants).

Controlled human exposure studies (published several years
ago) indicated that asthmatics are not more sensitive to
ozone than the general population. However, more recent
epidemiology studies suggest that  there is a correlation
between  increased hospital visits  by asthmatics  and
increased ozone  concentration.  This difference may be
because previous controlled exposure studies employed only
very mild asthmatics.

*•  HSD scientists have reported that  more severe
   asthmatics appear to be more susceptible to 0.16 ppm
   ozone than normal subjects, as measured by lung
   function (Horstman et al.).

*•  In addition, HSD scientists demonstrated that allergic
   asthmatics exposed  to  relatively high (0.4 ppm)
   concentrations of ozone experience an eosinophilic-
   driven inflammation,  as opposed to the neutrophil-
   driven inflammation shown by normal subjects (Peden
   et  al.). This  study  also showed that the  upper
   respiratory passages of asthmatics who are exposed to
   ozone become sensitized so that a subsequent allergen
   challenge causes a more severe allergic reaction than
   if the asthmatic subject had  not  been exposed to
   ozone.

*  In order to determine if this "sensitization" occurs only
   at the high levels of ozone experienced in some areas
   of the country during the summer (e.g., the southern
   California  basin), or  if  even   moderate  ozone
   concentrations can  put asthmatics  at  risk,  HSD
   performed further studies. Allergic asthmatics were
   exposed to concentrations  of ozone  (0.10  ppm)
   slightly  below  the current standard. There were no
   observed ozone-induced decrements in lung function,
   and no apparent sensitization in the lower airways to
   a subsequent allergen challenge (Ball et al.).

*•  HSD scientists demonstrated that asthmatic children
   have elevated baseline levels of inflammatory cytokines
   in upper respiratory passages, suggesting a reason for
   their increased  sensitivity to inhaled  compounds
   (Noah,  Henderson, Henry et al.).

These studies provide important information to the Air
Program Office indicating that asthmatics  may indeed be
more susceptible to ozone than the general  population.
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      Respiratory Effects of Ait Pollutants
Many pollutants of concern to EPA are airborne gases or
particles. These substances include "criteria pollutants"
(e.g., ozone, acidic aerosols, particulate pollution), indoor
air organic  and biological pollutants, air  toxics,  and
oxyfuels. The majority of airborne pollutants affect the
respiratory tract primarily and interact with cells and fluid
lining the nasal passages, large and small airways, and gas
exchange region of the lung.

During the post year, HSD has focused on examining the
respiratory effects of three pollutants:

•  Methyl tert-Butyl ether (MTBE)
•  Particulate Matter < 10 microns (PM10)
•  Ozone

MTBE	
The 1990 Clean Air Act requires that those areas that do
not attain the National  Ambient Air Quality Standard
(NAAQS) for CO must add oxygenates (e.g., MTBE) to
auto fuels. When MTBE-blended fuel was introduced into
Anchorage and Fairbanks, Alaska in November of 1992,
some citizens complained of acute symptoms (e.g.,
headache, nausea, sore throat, eye irritation, etc.), which
they attributed to the presence of MTBE in the gasoline.
HSD scientists performed studies  in response  to these
complaints (Prah et al.) that demonstrated that humans
exposed to likely ambient concentrations  of MTBE in
controlled  chamber  studies did not report increased
symptoms, changes in objective or cognitive measures,
or physiological  changes such as respiratory tract
inflammation. This important study, which won a bronze
medal, was cited  by  EPA as evidence that  pure MTBE
does not  cause   overt  changes  in  normal  healthy
individuals.
PM10 (Particulate Matter <10 microns)
Recent epidemiological studies suggest that particulate air
pollution causes substantial increases in  mortality and
morbidity every year in the U.S.  However, there has
been no link established between mortality and morbidity
and a specific component of air pollution.

*  HSD scientists and their colleagues have been testing
   the hypothesis that transition  metals (iron, nickel,
   vanadium) present in urban air particulate pollution can
   cause inflammation and lung cell damage, which, in
   turn, contributes to observed morbidity and mortality.
   HSD scientists demonstrated a relationship between
   the amount of transition metal present on particulate
   air pollution from  several sources and the ability of
   that particulate to generate  free radicals and induce
   lung damage in animals (Pritchard et al.).

*  HSD  scientists  also  characterized  and  identified
   substances present in particulate air pollution that are
   capable  of binding  metals  and  demonstrated a
   relationship between their presence and the amount
   of bound metal (Ghio et al.).

Ozone	
Nearly all studies of humans exposed to ozone have
examined effects in healthy, young, white male subjects,
leaving open the question of whether this group is
representative  of the population as a whole.  HSD
scientists have demonstrated that gender and race do not
affect responsiveness  to   low levels  of ozone  for
moderate  duration  exposures  (2.66  hours), and that
socioeconomic status and menstrual cycle phase did not
alter  pulmonary response  to ozone  (Seal  et al.).
However,   this  study   showed  that   decreasing
responsiveness to ozone occurs with increasing age. This
"age factor" finding is very important in light of the Clean
Air Act  requirement to  protect the  most sensitive
individuals  in the population.
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Ambient Exposures
In  addition to conducting controlled exposure studies,
HSD researchers also investigated the respiratory effects
of pollutants in "real world" settings.

*•  HSD  scientists collaborated  with  scientists from
   Harvard and Mexico City (Castillejos et al.) in a study
   that measured lung function responses of Mexico City
   school children who were exposed to ambient  air
   pollution. The observed magnitude of response of the
   children was very similar to the response of young
   adults exposed to similar levels of ozone in controlled
   exposure studies. Data from such studies can be used
   to predict the response of children living in areas with
   high ambient levels of ozone.
   A collaborative study  by HSD, NERL,  and UNC
   scientists demonstrated that people living downwind
   of hazardous waste incinerators in  Charlotte, NC,
   have neither decrements in lung function nor increased
   upper respiratory tract inflammation  compared to
   matched control  populations (Shy et  al.). These
   findings  suggest that products of hazardous waste
   incinerators do not cause acute respiratory effects in
   nearby populations.
*  Progress in environmental epidemiological studies has
   been hampered by the lack of methods available for
   accurately measuring human exposure and biologically
   effective dose (Zenick and Griffith; Lee et al.).

Neither questionnaires nor environmental monitoring have
provided consistent quantitative  assessment of pollutant
exposures on an individual or population level. In efforts to
advance epidemiological studies, biomarker methods have
been developed to separate, identify, and quantitate human
exposure to pollutants of concern to EPA, such as polycyclic
aromatic compounds and nitroaromatic compounds. The Air
Office has estimated that these two classes of compounds
contribute significantly to human genetic and cancer risk.

*•  HSD scientists have developed biomarker methods for
   these   compounds,   demonstrating   that   urine
   metabolite analysis is a highly  sensitive measure of
   recent exposure to polycyclic aromatic hydrocarbons
   (Mumford  et al.). Advancements were also made in
   the separation and identification of aromatic and nitro-
   aromatic DNA adducts (Zhan  et  al.; Savela et al.).
Further  development  and  validation  of  both urine
metabolite and DNA adduct analysis is essential for the
application of these methods  in  ongoing and  future
epidemiological  studies  of  environmental  pollutants.
Development of these biomarker methods will provide
the tools necessary to quantitate human exposure and
dose in future air toxics epidemiologic studies.

DNA Adducts	        /:  :
Because cardiovascular disease is one of the major causes
of death in the U.S., it is important to  determine if
environmental pollutants are a contributing factor to its
development. In order to investigate  the role of air
pollution  in   cardiovascular disease,  we need  to
understand molecular mechanisms in the disease process
that may be used to develop biomarkers of dose to the
heart  and early molecular  markers  of damage  to
cardiovascular cells.

Of particular interest in this area is the increasing evidence
of a possible link (DNA adducts)  between cardiovascular
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disease and cancer. The evidence includes findings  that
show that  genetic damage and mutations initiate the
formation of both cancer (via alterations in oncogenes and
tumor suppressor genes) and cardiovascular disease (via the
formation of atherosclerotic plaques). The hypothesis that
DNA-adduct  forming  agents induce both  mutations  in
cancer-related genes and mutations in the arterial smooth
muscle cells that lead to the formation of atherosclerotic
plaques (pathogenetically comparable to the formation of
 small benign tumors in the arteries that clog the blood
vessels) is under investigation.

*•  Past HSD research has shown that DMA adduct levels
   of smokers are exceptionally high in lung tissue and
   even higher in the heart. HSD scientists have recently
   found evidence of the presence of elevated levels of
   DMA  adducts  in  the  smooth  muscle  layer  of
   atherosclerotic lesions from abdominal aorta samples
   (Izotti et al. "Cancer Biomarkers"). These  findings
   support the future use of DMA adducts as a biomarker
   of dose to the cardiovascular system  and a biomarker
   of genetic damage to the smooth muscle cells.
         Dosimetry of Particles and Cases
Accurate  determination  of regional  dose  plays an
important role in understanding mechanisms of adverse
health effects of inhaled pollutants. Dose distribution of
inhaled gases and particles is heterogeneous in the lung,
causing certain local lung regions to receive more doses
than  others. This effect is  particularly pronounced in
subjects   with  lung  disease,  including  asthmatics.
Consequently, enhanced local  dose  may  become a
triggering  point  of  biological  responses even  if the
average lung dose is within the acceptable range.

Although  total uptake of ozone into the human lung has
been studied, very little is known about regional deposition
of ozone, which  is important because cells residing in
different regions of the lung may have different sensitivities
to ozone. Regional deposition becomes more significant in
susceptible  populations   because  of  altered  airway
structures.

*  HSD scientists characterized ozone uptake in  four
   different airway regions  in normal subjects in vivo
   (Gerrity  et  al.).  This  characterization  advances
   knowledge of the dose-response  relationship  of
   inhaled ozone, leading to improved identification of
   the sites of potential ozone damage in the airways, and
   to better understanding of potential toxic mechanisms.

Traditionally,  lung  function tests  are  used to measure
changes  in airway caliber following pollutant exposure.
However, minor airway obstructions induced by pollutants
are difficult to detect by conventional lung function tests.

*  In order to advance testing in this area, HSD scientists
   studied a new aerosol bolus technique with respect to
   lung volume, gender, and volume of bolus delivered
   (Brown et al.). This study demonstrated the potential
   use  of  this  technique to  measure small  airway
   obstructions in humans exposed to air pollutants.

Medical nebulizers are routinely used to deliver aerosolized
medications and challenging agents in human exposure
studies. However, actual aerosol dose delivered to the lung
is  usually unknown.

*  By measuring the actual dose of  aerosol delivered
   under a normal continuous operating mode, HSD
   scientists demonstrated that the dose delivered to the
   mouth was only 1.6% of  total dose placed in the
   nebulizer (Kim  et al.). These findings are useful for
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  advancing the design of airway challenge protocols and
  for interpreting bronchial challenge response data.

Certain  epidemiology  studies suggest that  exposure  to
paniculate pollution results in thousands of excess deaths
per year. One of the more  important issues facing the Air
Office is deciding how much weight to put on these findings.
In order to assess the potential risk of paniculate pollution
to humans, it  is critical  to  understand  the  deposition
patterns and rate of panicle clearance from the lungs. The
prevailing opinion has been that particles deposited in the
ciliated airways are cleared out from the  lung within 24
hours. However, recent studies have challenged this notion
and  claimed  that particles persist in the large ciliated
airways for some time.

* HSD scientists demonstrated complete clearance of
  particles from the large airways of dogs following
   intrabronchial deposition, confirming the conventional
   understanding of particle clearance kinetics (Lay et al.).
   This  finding is  important  for  estimating particulate
   toxic burden in the lungs of humans exposed to air
   pollution.

In  developing  dose-response   relationships,   individual
variability factors such as breathing pattern, age, gender,
etc. are usually not accounted for  because little is known
about how these factors affect deposition of particles in the
lung.

*•  HSD scientists  have  demonstrated  that breathing
   pattern and airway resistance are the most significant
   factors affecting total lung deposition of fine particles
   in normal subjects (Bennet et al.). This study also
   reported that age and gender had only minor effects,
   which is helpful information for  improving models that
   predict particle  deposition in the lungs of humans.
mgn Biologically Based Dose-Response (BBDR) Models
Information directly relating a particular exposure to
human  response  is  often not  available.  Therefore,
regulatory standards or risk assessments must frequently
be  based upon data from other species or exposure
regimens. BBDR models, which use physiological theory
and mechanistic understanding to characterize exposure-
response relationships, provide a means by which related
data can be used to generate the specific predictions of
human  response required for  standard setting or  risk
assessment.

In  particular,   BBDR models  facilitate  general  case
predictions, cross-species  extrapolation, short-term to long-
term exposure extrapolation, and route-to-route extrapo-
lation.  There is a large amount  of individual variability in
acute response to ozone exposure, as well as to many other
toxicant exposures. Models that allow for this variability are
not well developed.
*  In order to advance these modeling methods,  HSD
   scientists developed a model that allows description of
   individuals responding to ozone exposure as a function
   of  ozone  concentration  and exposure  duration
   (McDonnell  et al.). These  results are  important
   because they provide risk models that describe the
   number of individuals who are expected to  respond
   adversely  to  ozone  exposure   as a  function  of
   concentration and duration. Such models can be used
   in risk and benefit assessment for considering various
   regulatory  scenarios.  In   addition,  the   methods
   developed using the available ozone response database
   are  likely to  be useful  for  describing exposure-
   response relationships for other inhaled toxicants.

Carboxyhemoglobin (COHb) formation resulting from CO
exposure  can   be   accurately   predicted  using  the
Coburn-Forster-Kane equation (CFKE),  but only if a number
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of physiological parameters are known. These parameters
are  usually estimated for static conditions from normative
tables,  a laborious  and  sometimes  impossible  task.
Physiological parameters are interactively influenced by
exercise, age,  body  weight,  gender,  altitude,  other
pollutants, and many other factors.

* In  order  to  improve  this method, HSD  scientists
  performed a study (Benignus) in which the CFKE was
  incorporated  into  a  pulmonary  and  blood  gas
  physiological  model found  in the  literature. The
  augmented model  allows prediction of approximately
  50 physiological  and  blood gas values (including
  COHb), given a continuously changing mix of CO, O2,
  and  CO2.   Exercise,   altitude,  and  physiological
  abnormalities are also simulated. This model runs on
  desktop  computers and permits extremely rapid
  prediction of COHb (and some  of  its physiological
  results) without having to resort  to  tables - even in
  complicated exposure conditions.

In vitro  toxicology helps to advance the  understanding of
pollutant mechanisms and provides a  means for animal to
human extrapolation. In humans, the primary target of most
inhaled  pollutants is  the lung epithelial  cell. One of the
problems associated with using in vitro  toxicology with these
cells is the difficulty of obtaining the cells on a regular basis.
  HSD  scientists  have  significantly  diminished this
  limitation  by demonstrating that  an immortalized
  human airway epithelial  cell line (BEAS2B)  retains
  many important properties in common with primary
  human airway  epithelial  cells  (Noah,  Henderson,
  Henry et al.). This research, coupled with previous
  findings from HSD scientists, has validated the use of
  this cell line for studies with air pollutants. Since the
  initial reports from HSD, investigators from  several
  laboratories around the world have now begun using
  this cell line for in vitro toxicology.

  HSD  scientists have also developed a  qualitative
  extrapolation model, which shows that a combination
  of in vitro ozone exposure of animal  and  human
  respiratory tract  cells, coupled with in  vivo  animal
  exposure studies, can accurately predict the response
  of humans, as measured by host defense endpoints
  (Selgrade et al.). A quantitative model is now being
  developed  that will (upon validation) enable the Air
  Program Office to make better use of animal  data in
  assessing human risk, particularly of those pollutants
  for which little, if any, human data are available.
      Tepllce Projects Environmental Epidemiologic Studies in an Industrialized Region in Eastern Europe
Severe  environmental pollution in the former Soviet
countries of Central and  Eastern Europe led  to an
international concern  that  human  health  in  these
countries was at risk. Special funds were appropriated
through Congress to provide technological and scientific
assistance in the assessment and cleanup of the major
sources of pollution. NHEERL had a unique  opportunity
to  make  a major  contribution  to  one  of  these
environmental projects, the Northern Bohemia-Teplice
Project in the Czech Republic. EPA's objectives were to
assist the Czech  Republic  to develop a risk-based
approach  to  setting  priorities   for  environmental
decisions. NHEERL's objectives were to characterize the
relationship between human exposure to environmental
pollution and health effects in adults, newborns,  and
children in the Teplice District. Exceptionally high levels
of air pollution resulting from heavy industrialization in
Northern Bohemia had  resulted  in  obvious  adverse
effects on the ecosystem (e.g., deforestation) and a few
reports of unusually high incidences  of cancer, birth
defects,  and neurotoxicity in the population. These
reports had not been well documented or published in
peer-reviewed  international  journals prior to  1990.
NHEERL scientists from four of the health divisions have
collaborated with a multidisciplinary team of Czech
scientists to conduct a  major  long-term study of
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                                                                                   HUMAN STUDIES DIVISION
respiratory, neurobehavioral, reproductive, and genetic
effects on  the population in the Teplice District. The
research focused on the health effects of air pollution and
specifically on the  toxic components associated with
respirable particles (PM2.5). EPA scientists organized the
first peer review of this program  and have provided
training and guidance to the Czech  scientists who have
organized two subsequent peer review panels. Members
of the Czech scientific team have all received training in
NHEERL laboratories and have increasingly participated
in the presentation and  publication of studies, which have
contributed to a scientific assessment of human health
risk from  airborne particulate  matter  in the  Teplice
District, as follows:

•   Elevated prevalence and risk for respiratory symptoms
   in school children that were related to the air pollution
   exposures (Hnizdo et al.).
•   Neurobehavioral performance in the same population
   of children was not consistently  related to their air
   pollution exposure (Broadwell et  al.).
•   Personal  exposure to  PM2.5 was  highly  correlated
  with exposures to carcinogenic  polycyclic aromatic
   hydrocarbons (PAH) in the air (Watts et al.).
•   DNA adducts in the  white  blood cells  were also
   significantly elevated and  correlated with personal
  exposures to carcinogenic PAH (Binkova et al.).
These findings have important implications for cancer and
reproductive risks from air pollution and  have led to
additional biomarkers for the reproductive epidemiologic
studies that are in  progress.  These  peer-reviewed
publications are the  first scientifically well-documented
reports on the health  effects of air pollution  in this
region. This  research  program has  also  provided
NHEERL with an environmental laboratory to test and
validate measures of human exposure, uptake, dose, and
adverse respiratory and reproductive effects.
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                                                                                                      HUMAN STUDIES DIVISION
 Table 34.  HSD Issues and Accomplishments Overview
 Sensitive  Subpopulations (Asthmatics)
 Are asthmatics more susceptible to
 ozone than the general population?
•   More severe asthmatics are more susceptible to 0.16 ppm ozone than normal subjects.

•   Allergic asthmatics exhibit eosinophil (rather than neutrophil) driven inflammation when exposed to
    relatively high levels of ozone (0.4 ppm).
*   Exposure to ozone sensitizes upper respiratory passages in asthmatics so that subsequent exposure
    to allergens causes more severe allergic reaction.

*   Lower level (. 10 ppm) exposure to ozone causes no ozone-induced asthma or increased sensitivity to
    allergens in allergic asthmatics.

•   Asthmatic children have elevated baseline levels of inflammatory cytokines in upper respiratory
    passages, suggesting why they are more sensitive to inhaled compounds.
 Respiratory Effects of Air Pollutants
 Can scientific evidence be shown to
 support claims that methyl tert butyl
 ether (MTBE added to gasoline) causes
 acute symptoms (e.g., headaches,
 nausea, sore throat, eye irritation, etc.)
 in exposed populations?
•   In controlled chamber studies, demonstrated no evidence of detrimental effects from exposure to
    MTBE.
 Can links be shown between
 mortality/morbidity (as reported in
 epidemiological studies) and a specific
 air pollution component?
•   Demonstrated a relationship between amount of transition metal present on paniculate air pollution
    (from several sources) and lung damage induced in animals.

•   Characterized and identified substances in particulate air pollution capable of binding metals.
 Do healthy, young white males
 adequately represent the population as
 a whole with respect to ozone
 sensitivity?
    Demonstrated that neither gender nor race affects responsiveness to low-level ozone exposure (2.66
    hours) and neither socioeconomic status nor menstrual cycle phase affect pulmonary response to
    ozone, but that age is a factor.
 How does exposure to ambient ozone
 air pollution compare to exposure to
 ozone in controlled situations?
•   Demonstrated that responses to ambient air pollution (high ozone) were similar to those in
    controlled settings.

•   Demonstrated that products of hazardous waste incinerators do not cause acute respiratory effects
    in nearby populations.
 What is the significance of biomarkers
 and what evidence is there to support
 the future use of DMA adducts as
 biomarkers?
    Showed that environmental epidemiological studies have been limited by methods available for
    measuring human exposure or biologically effective dose.
    Identified urine metabolite as a highly sensitive measure of recent exposure to PAHs and made
    advancements in separation and identification of aromatic and nitroaromatic DNA adducts.

    Showed evidence of the presence of DNA adduct levels in smooth muscle layer of atherosclerotic
    lesions from abdominal aorta samples.
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 Dosimetry of Particl.es and  Gases
 Issue
 How can measurement of regional
 deposition of ozone be improved?
    Characterized ozone uptake in four different airway regions in normal subjects in vivo.

    Demonstrated potential use of a new aerosol bolus technique for measuring small airway
    obstructions in humans exposed to air pollutants.

    Demonstrated that, using a nebulizer, aerosol dose delivered to the mouth was only 1.6% of total
    dose placed in the nebulizer.
What weight should be given to recent
 studies that claim that particles persist
 in large ciliated airways for some time?
    Demonstrated complete clearance of particles from the large airways of dogs following intrabronchial
    deposition, the confirming conventional understanding of particle clearance kinetics.
What are the most significant factors
 affecting total lung deposition of fine
 particles?
    Demonstrated that breathing patterns and airway resistance are most important in total lung
    deposition of fine particles.
 Biologically Based  Dose Response (BBDR)  Models
                                       HSD Accomplishment
 How can variability in acute response
 to toxicant exposure be captured
 better to provide improved risk
 models?
•   Developed model that predicts the proportion of individuals responding adversely to ozone exposure
    as a function of ozone concentration and exposure duration.
 What can be done to make the
 Coburn-Foster-Kane equation (CFKE)
 easier to use in predicting
 Carboxyhemoglobin (COHb)
 formation due to CO exposure?
•   Incorporated the CFKE into an existing desktop computer-run model which allowed rapid prediction
    of 50 physiological and blood gas values without resorting to tables.
 How can human lung epithelial cells be
 made more accessible for in vitro
 toxicology study?
    Validated the immortalized human airway epithelial cell line BEAS23 for use in studies of air
    pollutants.
 What can be done to make better use
 of animal data in assessing human risk,
 particularly where human data are
 scarce?
 The Teplice Project
 Issue
    Developed a qualitative extrapolation model that showed that a combination of in vitro animal and
    human studies coupled with in vivo animal studies can accurately predict human response as
    measured by host defense end points.
USD Accomplishment
 What significant findings have come
 from the Teplice Project, in terms of
 assessing human health risk from
 airborne particulate matter?
    Air pollution exposure in school children was related to prevalence and risk for respiratory symptoms
    but not for neurobehavioral performance.

    Found that personal exposure to PM2.5 and elevated DMA adduct levels in white blood cells were
    highly correlated with exposures to airborne carcinogenic PAHs.
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                                                                            NEUROTOXICOLOGY DIVISION
Important Scientific Issues
    The full range of neurotoxic effects
    reported in humans includes motor,
sensory,  cognitive,  and  autonomic
disturbances,  and  these effects  are
studied   at   the   neurobehavioral,
neurophysiological, neurochemical, and
neuroanatomical  levels   of   nervous
system organization. NTD consists of a
Cellular  and  Molecular  Toxicology
Branch, a Neurophysiological Toxico-
logy Branch,  and  a Neurobehavioral
Toxicology Branch.

Most   biological   manifestations   of
mammalian  life,  including  muscular
movements,  reproductive  capability,
respiration, cardiac function, sensation,
perception, and  learning/memory are
controlled by the nervous system, which
comprises the brain, spinal cord, and a
complex  network   of  central   and
peripheral nerves and supporting cells.
The proper functioning of the nervous
system is essential for good health and
productive  life.  One of  the major
functions of the nervous system  is to
transmit information or commands from
one component of the body to another;
this  function is accomplished  by  a
complex interaction of various kinds of
nerve cells. Interruption of this process
can result in a variety of effects, such as
lowering of IQ scores in children; more
severe  indications   of   neurological
dysfunction, such as paraesthesias in the
extremities,   muscle  weakness,   or
seizures;  or  neurodegenerative-like
syndromes resembling naturally occur-
ring diseases such  as Parkinson's  and
Alzheimer's diseases.
Neurotoxicants   are  chemicals  that
interfere adversely with the  structure
and/or function of the nervous system.
The Agency receives  approximately
1500 notices of intent to produce new
substances   each  year,  and  65,000
chemicals are already listed in the EPA
inventory of chemicals. Estimates of how
many of these  chemicals are  neuro-
toxicants  depend  on  the  class  of
chemical and the exposure scenario. For
example, of the more than 1,400 active
pesticides registered by  the Agency,
more than  half are considered to be
neurotoxic. Approximately 20% of the
chemicals in the Agency's Integrated Risk
Information  System list neurotoxicity
either wholly or in part  as the basis for
the reference dose or  concentration.
Estimates of potential neurotoxicants in
the Agency's inventory range from 2,600
to over 18,000. Concern about expo-
sure to neurotoxicants has increased in
the last several years and has resulted in
several  publications, including a 1990
report by the Office  of Technology
Assessment (Neurotoxicology: Identifying
and Controlling Poisons  of the Nervous
System) and  a 1992 publication  by the
National Research Council outlining the
principles of Environmental Neurotox/-
co/ogy. Developmental neurotoxicity was
a particular concern noted in the 1993
publication  of the National  Research
Council on  Pesticides in  the Diets of
Infants and  Children. Neurological and
behavioral effects were noted in a recent
workshop sponsored by the Agency
concerning   the  influence of  neuro-
        Neuro-

toxicology

      Division
The Neurotoxicology Division
  (NTD) conducts research to
 provide a scientific basis for
      predicting whether an
   environmental agent will
  produce neurotoxicity. The
   general approach for this
  research acknowledges  the
      integrated nature and
   complexity of the nervous
system, both structurally and
      functionally, and uses
       methodological and
     conceptual advances in
    neurology, experimental
       psychology, and  the
neurosciences to identify and
     characterize chemicals
    potentially neurotoxic to
                 humans.
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endocrine disrupters  in the environment. That  the
Agency views neurotoxicity as a high priority is reflected
by the recent publication of the proposed neurotoxicity
risk assessment guidelines in the  Federal Register in
October 1995.
Research  in  NTD is organized  around  the  risk
assessment paradigm. Current studies focus on  the
development and validation of methods to determine
whether or not exposure to a chemical  produces an
adverse effect and whether an adverse effect can be
defined  as  neurotoxicity  (hazard  identification).
Estimating the association between the dose and effect
for various conditions of exposure (dose-response
assessment) helps provide information to the Agency
concerning chemicals of interest, using the best available
procedures and chemical-specific data strategies.
FY1995 Accomplishments
         Hazard Identification
Premarket  testing for pesticides is required by EPA
under  the  Federal  Insecticide,  Fungicide,  and
Rodenticide Act. Evaluation of industrial chemicals may
also be required under the Toxic Substances Control
Act. Current research  in NTD focuses on  providing
data in support of  existing  neurotoxicity guidelines,
identifying  areas where additional guidelines may be
needed, and assisting risk assessors in interpreting data
submitted to EPA by industry in response to the testing
guidelines.

Currently, NTD is focusing on the continuing validation of
the functional observational battery (FOB) and motor
activity, which are now used  routinely in-house and by
industrial and contract laboratories to detect a wide range
ofneurotoxic agents.

*•  The  FOB and   motor activity were  used in  a
   comparative study along with measures of systemic
   and developmental toxicity to assess the acute and
   subacute effects  of 10 industrial  and  agricultural
   chemicals (Berman,  et al.; MacPhail et al.; Moser,
   Cheek   et  al.).  Significant  dose-  and  exposure
   scenario-related effects were detected by the FOB,
   and chemicals having different mechanisms of action
   were  found  to  produce  different  patterns  of
   neurotoxicity. Chemicals expected to have little or
   no neurotoxicity affected some behavioral  measures
   at high doses.
   Other NTD studies (Goldey, O'Callaghan et al.)
   showed that a battery of tests for preweaning rats
   was  not  sensitive  to the  neurotoxic  effects of
   prototypic developmental neurotoxicants.   It has
   been inferred from such results that testing for
   developmental neurotoxicity may not be essential
   because currently existing guidelines for teratology
   studies may  be  sufficient  to  detect  potential
   developmental neurotoxicants.

   However, a systematic literature review revealed
   that the  measures  used in  the  Chernoff-Kavlock
   teratology assay detected only about 60% of the
   known developmental  neurotoxicants included in a
   survey (Goldey, Tilson et al.). This finding indicates
   that additional work is needed to find cost-effective,
   sensitive indicators of developmental neurotoxicity.

   NTD  has also  helped to  develop  and  validate
   electrophysiological   measures  to   detect   and
   characterize sensory deficits (Boyes). These studies
   support   the  contention  that  sensory  evoked
   potentials in animal models are qualitatively similar to
   those obtained in humans  in terms of waveform
   measurement,   anatomical   substrates,    and
   responsiveness to chemicals. Such information  is
   important because of a recently developed testing
   guideline  for evoked potentials, which is currently
   under EPA review.
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*•  Procedures for assessing sensory function have also
   been  developed  for  studies  involving  humans
   exposed to environmental chemicals (Anger et al.;
   Broadwell et al.).

NTD has been developing mechanistically based tests to
identify generic neurochemical/neuroanatomical markers
of injury to the nervous system, such as glial fibrillary acidic
protein (CFAP).

*  NTD   researchers   have   recently  studied   the
   expression of GFAP in transgenic mice (Miller, Bartke
   et al.)  and the possible role of cytokines as possible
   markers  of injury  in the  central  nervous  system
   following chemical exposure (Maier et al.).

+  Dose-  and  time-dependent  increases  in   the
   expression of cytokine mRNAs in the hippocampus of
   rats exposed to a prototypic neurotoxicant suggest
   that increased expression of cytokines, like GFAP,
   may also  be an early indicator of injury to the brain
   following chemical exposure.

*•  Procedures involving tissue cultures are being used
   with greater frequency in hazard identification,  and
   there  is considerable interest in  developing such
   procedures for neurotoxicity testing (Atterwill et  al.).
   One area of promise concerns the use of tissue
   culture techniques  to  measure  changes  in  key
   enzymes  such as neuropathy target esterase (NTE)
   associated with the manifestation of delayed
                                                                               NEUROTOXICOLOGY DIVISION
peripheral  neuropathy induced by  cholinesterase-
inhibiting  insecticides.  Current  testing guidelines
utilize    neurological,    neuropathological,   and
neurochemical assessments of hens  after acute and
repeated dosing with organophosphate compounds.

Work in NTD on potential use of in vitro preparations
to assay NTE (Ehrich, Correll et al.) showed good
agreement in response of cells from humans and
rodents to organophosphates that  are known to
produce a delayed neuropathy in humans (Ehrich and
Veronesi  et  al.).  Such information is crucial to
establishing appropriate conditions for using tissue
culture   techniques  and  for  determining  the
appropriateness of extrapolating in vitro data derived
from rodents to humans.

Other NTD research has focused  on identifying
potential  endpoints  that  could   be  associated
mechanistically with chemical-induced neurotoxicity.
For  example,  it  has been proposed that  some
chemicals may produce neurotoxicity by interacting
with the immune system.

NTD researchers have found that neuropeptides may
be  involved  in  mediating chemical-induced  skin
irritation  (Veronesi  et al.),  suggesting  a  neural
connection in this important response to toxicological
injury. Initial work is also underway to explore the
possible role of free  radical/oxidative  reactions in
environmentally related neurodegenerative diseases
such as  Parkinson's disease (Sengstock et al.).
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A large component of NTD's research program focuses
on reducing  uncertainties  in  the risk  assessment
process.   For   example,   reference   doses   or
concentrations are derived from the following formula:
RfD=NOAEL (LOAEL)/UFs', where UFs are factors of
up to 10 for intrapopulation variability, animal-to-human
extrapolation, and less-than-lifetime exposures. NTD
research is designed to elucidate variables affecting the
quantitative estimate of risk, including factors that could
influence the estimation of the NOAEL or LOAEL.

Research to Reduce Uncertainties in the
NOAEL or LOAEL      T     ;

Calculation of the RfD begins with the determination of
the NOAEL or LOAEL based on results from a critical
study. It is important for the risk assessor to know that
the estimation of the NOAEL or LOAEL for some
neurotoxic endpoints can be shifted to the left or right
on the  dose-response  curve  by  a number  of
environmental or dosing variables.

For example, it is generally known that the presence and
magnitude of neurotoxicity can be affected significantly by
environmental factors that alter the neuroendocrine status
of the organism. Stress has been shown to  affect  the
manifestation of chemical-induced neurotoxicity and can
have a significant effect on quantitative and qualitative
estimates of neurotoxic risk.

*•  NTD researchers  (Miller  and O'Callaghan) have
   shown that temperature stress significantly enhances
   the  expression  of  neurotoxicity  produced  by
   prototypic neurotoxic agents.
    RfD = Reference Dose
 NOAEL = No Observed Adverse Effect Level
 LOAEL = Low Observed Adverse Effect Level
     UF = Uncertainty Factor
* Other studies at NTD have investigated the possible
  contribution  of route  of administration  to the
  neurotoxicity  of deltamethrin,  which  has  been
  reported in the literature to vary by as much as three
  orders of magnitude. NTD research (Crofton, Kehn
  et al.) showed that the potency of deltamethrin
  depended  on  both  the vehicle  and  route of
  administration.

intrapopulation Variability

Differences  in sensitivity to neurotoxic agents within a
population of exposed individuals can have very long-term
consequences (Barone,  Stanton et al.).

* Recent studies have shown that early postnatal
  exposure to triethyltin produced transient effects on
  cognitive function  in rats at the time of weaning.
  However, as the animals matured and their cognitive
  abilities  started  to  decline,  the animals that had
  received triethyltin were more deficient in learning
  than their age-matched controls. These data indicate
  that  developmental exposure  to  chemicals can
  interact with normal aging and also caution against
  dismissing transient changes following developmental
  exposure as always being an indication of recovery.
  Compensation  for chemical   exposure   during
  development may obscure neurological damage that
  becomes evident  only  after the nervous system
  begins to age.

* It has also been suggested that using different strains
  of rats may affect the manifestation of neurotoxicity.
  NTD studies comparing the responsiveness of Long-
  Evans  and  Fischer-344 rats   to  a  prototypic
  neurotoxicant, trimethyl tin (Moser), have  shown
  significant baseline differences between rat strains,
  but the qualitative response to trimethyl tin was the
  same and the magnitude of the response varied only
  by a factor of 2-3. Other experiments (Gordon and
  Watkinson) compared the responses of four strains
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  of rats (Sprague-Dawley, Long-Evans, Fischer-344,
  and Wistar) to a cholinesterase-inhibiting chemical
  and found that Fischer-344 rats were less susceptible
  behaviorally   and  neurochemically.   Differences
  between  rat  strains,  however,  did not  differ
  qualitatively  nor were the  effects quantitatively
  different by more than an order of magnitude.  These
  results suggest that rat strain is not an important
  variable in determining the uncertainty factor for
  intrapopulation differences.

Less-Than^Ufetlme Exposures

It is  generally  accepted  that neurotoxidty  for some
chemicals  may  be evident  only following  repeated
exposures. One explanation for this observation is that
repeated exposure to some agents may alter the sensitivity
or excitability of the nervous system, leading to increased
susceptibility to subsequent  exposures  and  increased
incidence  of seizure-related  health effects.  Repeated
presentations of subthreshold electrical stimuli in specific
brain  regions can lead to enhanced seizure activity; this
phenomenon is known  as kindling  and is thought to
represent an experimental form of temporal lobe epilepsy.

* NTD studies have found that repeated exposure to
  the  pesticide  lindane  leads  to   a  behavioral
  sensitization that facilitates kindling (Gilbert) and that
  seizure thresholds in kindled rats are reduced by
        Chemical Specific Data
*• exposure to lindane and endosulfan  (Gilbert and
  Mack). These experiments underscore the possibility
  that repeated low-level exposure to some chemicals
  could alter the sensitivity of the CNS and lead to
  epilepsy-like symptomatology.

*• Other NTD studies have focused on understanding
  the cellular  mechanisms associated with increased
  sensitivity of the nervous system following repeated
  exposure to neurotoxic  agents (Qian et al.).
Interpretation    of
Assessment
Data   for    Risk
EPA published the draft Neurotoxicity Risk Assessment
Guidelines in October of 1995.

*  Papers written by NTD staff outlined the weight-of-
   evidence approach used in the guidelines (Tilson et
   al.) and special considerations that underlie risk
   assessment  following   developmental  exposures
   (Tilson). These publications are intended to provide
   peer-reviewed  guidance   to   EPA    personnel
   concerning  crucial  procedural steps  in  the risk
   assessment guidelines, and to address comments and
   criticisms raised in the past concerning the issue of
   neurotoxicity risk assessment.
NTD  research   employs  validated  methods  and
procedures to address scientific questions raised by
program offices  or the  larger scientific community
concerning specific chemicals or chemical classes.

Aluminum

Over the last decade,  there have  been concerns  that
aluminum in the drinking water may be associated with
the  etiology  of  neurodegenerative diseases  such as
Alzheimer's disease.
>•  NTD's recent review of the literature on this issue
   (Shafer and Mundy) concluded that the association
   between  aluminum  and Alzheimer's disease  was
   weak.

*•  However, the  review did  find  consensus  that
   aluminum  is a neurotoxic  metal and that further
   research was warranted. NTD research has shown
   that aluminum alters signal transduction mechanisms
   in brain tissue in vitro at relatively low concentrations
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   but revealed  no age-dependent sensitivity to the
   neurotoxic effects of aluminum (Mundy et al.).

*•  Other  NTD  studies  have  shown  that  in  vitro
   exposure to  aluminum  does not  alter  long-term
   potentiation or glutamate release in rat hippocampal
   slices, indicating that aluminum may have  general,
   nonspecific  effects on brain function (Gilbert and
   Shafer).

3,3'-IminodIproprionitrlle (IDPN)

Nitrites are used in a number of industrial applications.
IDPN is a  neurotoxic nitrite that adversely affects the
structure of both  the  peripheral  and central nervous
systems. Until recently, little attention had been paid to
the possible functional effects of nitrites such as IDPN.

*  Recent NTD studies have shown that IDPN appears
   to have a direct effect on both neural and nonneural
   structures in the eye and found a dose- and time-
   dependent progressive histopathology (Barone, Herr
   et al.).  Functional  studies  with  IDPN  revealed
   alterations in visual evoked potentials (Herr et al.).

*•  Subsequent experiments showed that IDPN  also
   produced functional and morphological evidence of
   cochlear damage and ototoxicity (Crofton, Janssen et
   al.), as well as  olfactory deficits in rats (Center et al.).
   These data confirm that IDPN affects more than one
   sensory system.

*  Other   NTD  studies   have  shown  that  IDPN
   significantly interferes with learning and performance
   of a spatial task  in rats, thus indicating that this
   compound  can  also  affect  cognitive processing
   (Llorens et al.).
Choltnesterase-Inhiblting Compounds

Research on cholinesterase-inhibiting pesticides is a major
component ofNTD's program. The main objectives of this
research  are to address  the adversity of cholinesterase
inhibition in animal models, the relative importance of
brain and blood cholinesterase inhibition, developmental
neurotoxicity, compensation following repeated exposure,
and ocular toxicity.

*•  An NTD study has shown that  a single exposure to
   fenthion produced persistent  neurochemical  and
   histopathological alterations in the rat eye (Boyes et
   al.). This finding suggests  that EPA should assess
   directly the risk of ocular toxicity following exposure
   to organophosphate insecticides.

*•  NTD scientists have also reported a novel method
   that markedly increases the sensitivity of the  standard
   erythrocyte acetylcholinesterase assay (Padilla et al.),
   which will prove helpful for the hazard characteri-
   zation of carbamates and organophosphates.

*•  Chlorpyrifos is an  organophosphate insecticide that
   produces     a    persistent     decrease    in
   acetylcholinesterase   activity.    Recovery   from
   chlorpyrifos is unusually slow  compared to other
   agents in this class, including parathion and methyl
   parathion. NTD  scientists (Chiappa  et al.)  have
   shown  that   persistent  decreases   in   brain
   acetylcholinesterase  activity  after   chlorpyrifos
   exposure reflected  a sustained  inhibition of the
   enzyme, not a loss of enzyme protein or suppression
   of message of the  enzyme.  This  information  is
   important because it provides the scientific basis for
   understanding the  persistent nature of chlorpyrifos's
   inhibitory  effect  on  brain  acetylcholinesterase.
   Cholinesterase inhibitors are frequently assessed on
   the assumption that there will  be  a rapid and
   complete  recovery  of function  following acute
   exposures.
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                                                                                NEUROTOXICOLOGY DIVISION
Risk assessment of the cholinesterase-inhibiting pesticides
depends heavily on characterization of their acute effects,
and it is generally believed that those effects are similar for
all compounds in this class.

*•  NTD research (Moser "Cholinesterase Inhibitors")
   compared  the  acute  effects of two  carbamates
   (carbaryl  and aldicarb) and five organophosphates
   (chlorpyrifos, diazinon, parathion, fenthion, and DFP)
   using the FOB and motor activity. The overall clinical
   syndrome was similar for all compounds, but there
   were compound-specific differences in the individual
   measures, dose-response, and time-course of action.
   These findings suggest that some differences may be
   expected in the spectrum  of effects produced by
   compounds of the same chemical class having similar
   mechanisms of action.

*  Current guidelines for organophosphates require
   testing of adult hens for delayed-onset neurotoxicity.
   More frequently used laboratory animals such as the
   rat are not recommended because they do not show
   clear clinical  impairment even in  the presence of
   histopathology.

*  Recent NTD studies (Ehrich, Jornter et al.) examined
   the   relationship    between    inhibition    of
   acetylcholinesterase and neuropathy target esterase
   (NTE, a biomarker of delayed neurotoxicity) in hens
   and rats exposed to agents known to  produce
   neuropathy in the hen. The rat did not develop overt
   and specific clinical  signs,  but the  hens did.  This
   observation, combined with limited neuropathology
   and difficulties in ensuring the survival of rats given
   these agents,  upholds the conclusion that the hen is
   the   more  appropriate   animal   species  for
   organophosphate hazard identification.

Perturbations in  homeostatic  processes, including the
regulation of body  temperature, are common effects in
experimental  animals   and  humans   exposed  to
anticholinesterase pesticides.
  NTD  research  has  provided  evidence  for  a
  behaviorally mediated reduction in core temperature
  in the rat following acute exposure to a prototypic
  cholinesterase inhibitor, diisopropyl fluorophosphate
  (DFP). Furthermore, during recovery  from acute
  DFP exposure, there was a persistent  elevation in
  core temperature lasting for several days (Gordon
  "24-Hour Control"). These data indicate that not all
  of the effects of acutely administered cholinesterase
  inhibitors are transient; in addition, the hyperthermia
  observed in rats may be similar to the fever that has
  been frequently  observed in humans  exposed to
  these agents.

  Additional  work  (Gordon  "Diisopropyl  Fluoro-
  phoshpate-induced Hypothermia") showed that the
  hyperthermia produced by DFP was inversely related
  to the baseline core temperature. These findings
  indicate that some  biologically significant adverse
  effects following acutely administered cholinesterase
  inhibitors could be diminished or obscured by testing
  parameters.
Neurotoxicity is  a primary  concern  after acute  and
repeated  spikes  of  exposure  to  VOCs  and  related
chemicals. Most previous studies of ototoxicity following
exposure to organic solvents have been restricted to low-
and mid-hearing frequencies.

*•  NTD research has revealed that inhalation  exposure
   to  styrene,  mixed xylene,  toluene,  and  1, 1,2-
   trichloroethylene caused hearing deficits only in the
   mid-frequency range (2-20 KHz)  and spared function
   at lower and higher frequencies (Crofton, Lassiter et
   al.). This information is useful because it indicates the
   sensitive range of hearing frequencies that should be
   assessed following exposure to solvents and suggests
   a common mechanism for a number of environ-
   mentally relevant solvents.
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NEUROTOXICOLOGY DIVISION
Polychlorinated
Dioxin

Risk assessments for dioxin and related PCBs are based on
the relative  potency of the chemicals to bind to  the
arylhydrocarbon (Ah) receptor. One class of PCBs,  the
ortho-substituted congeners, has little or no Ah receptor
activity, and previous research has indicated that  these
compounds may have  adverse effects  on the nervous
system.

*•  NTD  scientists  have  examined  a number  of
   neurochemical measures in vitro and found that PCB
   congeners with mono- and di-ortho- substitution
   affect cellular calcium homeostasis, while coplanar
   PCBs that bind to  the Ah receptor do  not affect
   calcium homeostasis (Kodavanti, Ward, McKinney et
   al.; Kodavanti, Ward, Tilson et al.). Characterization
   of this  effect using a prototypic ortho-substituted
   PCB revealed a biphasic effect on receptor-mediated
   phosphoinositide hydrolysis  and  translocation of
   protein  kinase-C in the nervous  system of rats
   (Kodavanti, Shafer  et  al.). These  data provide a
   neurochemical  measure to  use  in  performing
   structure-activity modeling and suggest future studies
   to identify the possible receptor target of neurotoxic
   PCB congeners.
                                                      Additional   NTD   research  focused   on   the
                                                      developmental  neurotoxicity  of  PCBs.   Recent
                                                      experiments showed that developmental exposure to
                                                      a mixture of PCBs (Aroclor 1254) caused persistent
                                                      hearing loss in animals tested as adults and that this
                                                      effect was associated with reduced circulating thyroid
                                                      hormone concentrations (Goldey, Kehn, Lav et al.).
                                                      This work also revealed that  the  hearing  deficits
                                                      produced by developmental exposure to PCBs could
                                                      be attenuated by treatment with thyroxine. Hearing
                                                      loss was also demonstrated with propylthiouracil, an
                                                      agent known to produce hypothyroidism in the rat
                                                      (Goldey, Kehn, Rehnberg et al.). Because it is known
                                                      that the development of hearing depends on the
                                                      availability of circulating thyroid hormones, these data
                                                      suggest that evaluation of children exposed to PCBs
                                                      should include measures of auditory function.

                                                      Other NTD studies (Gordon, Gray et al.) showed
                                                      that developmental  exposure of  rats  to dioxin
                                                      produced a persistent reduction in regulated  body
                                                      temperature  by decreasing the  homeostatic set-
                                                      point. These data suggest that fundamental metabolic
                                                      processes may be altered by developmental exposure
                                                      to dioxin and suggest the hypothalamus and, possibly
                                                      the  thyroid,  as  potential  target sites for  dioxin-
                                                      induced developmental toxicity.
us
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                                                                             NHEERL FY95 ANNUAL REPORT
                                                                             NEUROTOXICOLOGY DIVISION
Table 35. NTD Issues and Accomplishments Overview
Hazard Identification
-,.y • ••
Issue
What are the validity, sensitivity, and cost-
effectiveness of various measures being
used to determine neurotoxicity?
What is being done about the lack of tests
for chemical-induced alterations in
cognitive function?
What is being done to develop more
mechanistically based tests to improve
identification of potential neurotoxicants?
NTD Accomplishment
• Demonstrated the sensitivity and reliability of the functional observational battery (FOB) for
assessing chemicals for potential neurotoxicity.
• Found that a battery of tests for preweaning rats was not sensitive to the neurotoxic effects of
prototypic developmental neurotoxicants.
• Found that measures used in the Chernoff-Kavlock assay detected only about 60% of the known
developmental neurotoxicants included in a survey, indicating that additional work is needed to
find better indicators.
• Supported studies that revealed qualitative similarity between animal models and humans in
terms of waveform measurement, anatomical substrates, and responsiveness to chemicals.
• Developed procedures for assessing sensory function in studies involving humans exposed to
environmental chemicals.
• Developed animal models to evaluate chemicals for their effects on cognitive function.
• Supported use of transgenic models by advancing research concerning expression of glial fibrillary
acidic protein (GFAP) in mice.
• Demonstrated possible role of cytokines as indicators of brain injury in rats exposed to
chemicals.
* Demonstrated similar responses in human and rodent cells that were exposed to
organophosphates, thus advancing basis for extrapolation of in vitro data from rodents to humans.
• Found evidence to suggest that neuropeptides may be involved (a neural connection) in
mediating chemical-induced skin irritation.
Dose-Response Assessment
Issue
What may be done to reduce uncertainties
in no observed adverse effect levels
(NOAEL) or low observed adverse effect
levels (LOAEL)?
What is the significance of intrapopulation
variability in terms of sensitivity to
neurotoxic agents?
What are the effects of repeated
neurotoxic exposure on nervous system
sensitivity?
NTD Accomplishment
• Demonstrated that temperature stress significantly enhanced the expression of neurotoxicity
from prototypic neurotoxic agents.
• Found that deltamethrin potency depended on both the vehicle and route of administration.
• Showed that developing organisms, relative to adults, are differentially sensitive to many
neurotoxic agents and that evidence of neurological damage may be obscured until after the
nervous system begins to age.
• Found that rat strain is not an important variable in determining the uncertainty factor for
intrapopulation differences.
• Found that repeated exposure to lindane leads to behavioral sensitization that facilitates
"kindling" and that seizure thresholds in kindled rats are reduced by exposure to lindane and
endosulfan.
• Advanced knowledge of cellular mechanisms associated with increased sensitivity of the nervous
system following repeated exposure to neurotoxic agents.
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NHEERL FY95 ANNUAL REPORT
NEUROTOXICOLOGY DIVISION
 Chemical Specific  Data
 Issue
What scientific evidence can be provided
 concerning reports of aluminum
 neurotoxicity in vivo!
Concluded that there was no strong association between Al and Alzheimer's disease but found
consensus that Al is neurotoxic and warranted further study.

Found that relatively low concentrations of Al altered signal transduction mechanisms in brain
tissue in vitro but discovered no evidence of age-dependent sensitivity to neurotoxtc effects of Al.

Found evidence that Al may have general, nonspecific effects on brain function.
 What is the environmental significance of
 the class of chemicals known as nitriles?
Showed that 3,3'-iminodipropionitrile (IDPN) appears to have direct effects on both neural and
nonneural structures in the eye and found dose- and time-dependent progressive histopathology.

Demonstrated that IDPN affects more than one sensory system (alterations in visual evoked
potentials, cochlear damage and ototoxicity, and olfactory deficits in rats).

Found that IDPN can significantly affect cognitive processing.
 Is ocular toxicity following exposure to
 organophosphate insecticides an area of
 concern?
Found that a single exposure to fenthion produced persistent neurochemical and
histopathological alterations in the rat eye.
 Is rapid and complete recovery from acute
 exposure to cholinesterase inhibitors to be
 expected?
Found that persistent decreases in brain acetylcholinesterase activity after chloropyrifos exposure
reflected a sustained inhibition of the enzyme, not a loss of enzyme protein or suppression of
enzyme message.
 Are differences in effects to be expected
 from compounds of the same chemical
 class that have similar mechanisms of
 action?
Compared two carbamates and five organophosphates and demonstrated some differences in
the effects produced.
 Are current requirements for use of adult
 hens for organophosphate neurotoxicity
 testing valid?
Affirmed current guidelines for organophosphates that require testing adult hens for delayed-
onset neurotoxicity.
 How persistent are the adverse effects of
 acutely administered cholinesterase
 inhibitors in test animals?
Demonstrated that some effects of acutely administered cholinesterase inhibitors are not
transient and that observed rat hyperthermia may be similar to fever observed in humans
exposed to these agents.
Found that hyperthermia produced by diisopropyl fluorophosphate (DFP) exposure was inversely
related to animal baseline core temperature.
 What is the most current methodology for
 performing cholinesterase assays for
 hazard characterization of carbamates and
 organophosphates?
Reported a novel method that markedly increases the sensitivity of the standard erythrocyte
acetylcholinesterase assay.
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                                                                                                  NEUROTOXICOLOGY DIVISION
 Organic Solvents
                  Issue
 In ototoxicity studies, what range of
 frequencies should be assessed following
 exposure to solvents?
 PCBs and Dioxins
Found hearing deficits only in the midrange frequencies (2-20 kHz) in rats exposed by inhalation
to styrene, mixed xylene, toluene, and 1, 1,2-trichloroethylene.
 Is there evidence to suggest that evaluation
 of children exposed to PCBs should
 include measures of auditory function?
Found that developmental exposure to a mixture of PCBs caused persistent hearing loss
(associated with reduced circulatory thyroid hormone concentrations) in animals tested as adults
and that hearing deficits could be attenuated by treatment with thyroxine.

Demonstrated hearing loss with propylthiouracil (known to produce hypothyroidism in rats).
 What effect does developmental exposure
 to dioxin have on fundamental metabolic
 processes?
Showed that developmental exposure of rats to dioxin decreased the homeostatic set-point,
causing a persistent reduction in regulated body temperature.
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                                                                            NHEERL FY95 ANNUAL REPORT
                                                                     REPRODUCTIVE TOXICOLOGY DIVISION
Important Scientific Issues
    The production of healthy offspring is
    a  major concern  in the  human
population. In the United States, one out
of every ten couples seeks medical help
in achieving pregnancy. In addition, at
least 30 percent of all recognized human
pregnancies  fail to culminate in a live
birth owing to spontaneous abortions.
An  equal  number of  pregnancies are
believed to be lost before the time when
routine clinical indications of embryonic
growth can be detected.

While  these  spontaneous  abortions
naturally end most abnormal pregnan-
cies, approximately 3 percent of babies
born in the  United States suffer from
major  malformations and  roughly ano-
ther 3  percent are found to suffer from
subtle  changes expressed during post-
natal development. Intrauterine growth
retardation of unknown etiology is a high
risk factor not only for structural mal-
formations but for later developmental
dysfunctions,    including    childhood
learning disabilities.  Estimates by various
experts suggest  that  the cause(s)  of
adverse  reproductive outcomes  in
  Table 36. RTD Branches
                 humans are  unknown  for  the over-
                 whelming majority of the cases.

                 Concern about potential environmentally
                 induced   etiologies   has   increased
                 considerably in the last few years with
                 the  1993 publication of the  National
                 Academy  of  Sciences  report  on
                 Pesticides in  the  Diets of Infants and
                 Children, and with the widely circulated
                 hypothesis    that    environmental
                 contaminants  have  influenced   the
                 endocrine  system  and  hence  have
                 altered reproductive development and
                 function in a variety of  species.  For
                 example,  several recent publications
                 have suggested alarming evidence of
                 marked declines in sperm counts and
                 semen quality, and increases in testicular
                 and  genital abnormalities and testicular
                 cancer over the last several decades.

                 In order to address these vital issues, the
                 Reproductive Toxicology  Division  is
                 organized  into   three  branches,  as
                 shown  in  Table  36.  RTD  Branches,
                 below.
   RTD BRANCH
   Gamete and Early
   Embryo Biology
   Developmental
PRIMARY FUNCTION
Examine die processes of gamete formation and function

Focus on mechanisms responsible for birth defects

Explore dw impact of disturbances in endocrine systems on
  Reproductive
   Toxicology
         Division

The Reproductive Toxicology
  Division (RTD) is concerned
    with the effects ofxeno-
biotics on the developmental
  and reproductive processes
     of humans. In order to
  advance knowledge in this
       area of concern, RTD
  conducts research directed
      toward detecting and
   interpreting the effects of
 xenobiotics on the develop-
    mental and reproductive
     processes of laboratory
         animals. RTD then
  extrapolates the data from
  those models to the human
                situation.
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 NHEERL FY95 ANNUAL REPORT
 REPRODUCTIVE TOXICOLOGY DIVISION
RTD has developed a cohesive research program that is    Refer to Table 38. Issues and Accomplishments Overview,
designed around the five  guiding  organizational goals    for a quick look at some of the major RTD accomplish-
shown in Table 37. RTD Goals.                             ments of Fiscal Year 1995.
  Table 37. RTD Goals
                                                 EXAMPLE/COMMENT

                                                 Methanol, dioxin, atrazine, PCBs, and vinclozolin
                                                 Research on the predictiveness of measures of alterations in gonad and
                                                 reproductive tract function on fertility and the validation of the benchmark
RTD GOAL

I.  Apply scientific knowledge to high priority
   chemicals

2.  Clarify assumptions in the risk assessment
   guidelines.
   3.  Develop mechanistically basetl effect models,       Work with 5-fl,uoro«racil (S-FU), methancd, dioxin, and vinclozolin. By
                                                 understanding mechanisms of toxlcity, we will reduce the urrceitawttie*
   4.  Conduct
   5.
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FT 1995 Accomplishments
                                                                               NHEERL FY95 ANNUAL REPORT
                                                                        REPRODUCTIVE TOXICOLOGY DIVISION
       Development of BBDR Models
Biologically based dose response (BBDR) models begin
with an adverse effect and attempt to determine (to the
extent practical  and feasible)  the intervening  steps
between administration of a chemical and a resulting
health   effect.   These   knowledge-based   formal
mathematical  models of biological response facilitate
assimilation of relevant data and testing of model-derived
hypotheses.

BBDR models first gained prominence with  the work of
Moolgavkar and coworkers who developed a multistage,
mathematically based description of carcinogenesis.  Over
the last five years,  RTD scientists  have  been active in
developing  such  models for noncancer endpoints.  The
division's  emphasis on development of BBDR models has
continued with iterative research  on the 5-fluorouracil
(5-FU) model. Previously, we researched the effects of5-FU
on inhibition of thymidylate synthetase with subsequent
effects on  DNA  synthesis,  cell cycle  kinetics,  growth
inhibition, and hindlimb defects in rats exposed to GDI4.

*•  In the  past year, predictions from a computer model
   of the pharmacokinetics, nucleotide pool biosynthesis,
   and cell cycle kinetics (developed in parallel with the in
   vivo model by  R.W. Setzer of the Biometry Branch)
   were tested on the rat model.

In addition, other modes of action that might contribute to
developmental toxicity were pursued.

*•  Maternal administration of 5-FU produced fetal anemia
   as evidenced by decreases in cell counts, hematocrit,
   and hemoglobin content of fetal blood (Zucker et al.).
   A time course analysis indicated that the causative
   effect was a delay in reticulocyte release from the fetal
   liver.  Because only a brief (3-6 hour) exposure to
  5-FU is sufficient to induce limb malformations (Shuey
  et al.), it does not appear that the anemia, which takes
  about 48 hours to develop, is involved in the primary
  pathogenetic cascade. However, it likely plays a role
  in the overall growth retardation observed in treated
  fetuses over the final several days of pregnancy.  Thus,
  even for the  relatively well understood mechanism of
  action that 5-FU afforded, by attempting to account
  for  the  intervening steps  in  the  induction  of
  developmental toxicity, new insights and alternative
  modes of action have been uncovered.
& Future Effects:  This year, efforts  are being focused on
determining nucteotide poof tev«Js in exposed embryos w& on a
model cell culture system for comparison with some predictions
from the computer model.
Methanol  has been  proposed as  a  cleaner burning
alternative fuel for motor vehicles.  In hazard identification
research conducted by the division several years ago, we
discovered that inhalation exposure of mice to methanol
resulted in  multiple  birth defects  (exencephaly,  cleft
palate, altered skeletal  bones) at concentrations that
suggested concern  for  potentially  exposed humans.
Therefore, in 1992 we proposed a 5-year plan to develop a
BBDR  model for use  in the  upcoming methanol  risk
assessment.

*  This year we completed work on the  toxicity of
   methanol's  principal  metabolite,  formic acid,  in
   embryos exposed in an in vitro test system (Andrews
   et al.), and we described patterns of cell death in rat
   and  mouse embryos exposed  to methanol in  the
   same culture system (Abbott, Ebron-McCoy et al.).
   The in  vitro embryo  culture system allowed us to
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NHEERL FY95 ANNUAL REPORT
REPRODUCTIVE TOXICOLOGY DIVISION
   examine the  effects  of  exposure independent  of
   maternal metabolic influences, and to have precise
   control over the concentration and duration of the
   exposure.  The research  continues to indicate that
   methanol is the proximate developmental toxicant
   and confirms that the heightened sensitivity of the
   mouse compared to the rat in terms of developm-
   ental toxicity is due to an intrinsic property of the
   embryo  and not to differences in maternal meta-
   bolism between the two species. This accumulated
   evidence supports the relevancy of the mouse model
   to  the potential  effects in humans exposed  to
   methanol  in  an  environment that would  not  be
   expected to cause buildup of formate levels in the
   blood.
^Future Effects: tn the
search for early events in the
methanol, with specific attentiort
studies and quantitating
exposed embryos.
vw will be narrovwfjg the
    of defects caused by
  \"m  concentration-time
An  invited  article (Kavlock and Setzer)  reviewed  the
background for quantitative dose-response modeling in
developmental toxicity, including the  Benchmark Dose
Approach discussed  below and the BBDR models  and
suggested that a new concept, termed Embryologically
Based Dose  Response (EBDR) models,  is needed to
advance the use of mechanistic data in  risk assessment.

»•  EBDR models differ from BBDR models in that they
   begin with a model of embryonic development  of a
   particular organ system (e.g., limbs,  skeleton, palate),
   attempt   to  cover   normal   development,   and
   secondarily factor in how development can  be
   perturbed.  Thus, they can be considered "bottom
   up" models in contrast to the "top down" BBDR
   models.  Because these models would be based upon
   normal  morphogenesis,  they might  be  more
   generically  applicable across chemicals,  and  they
   should be instructive as to the relevance of findings
   across species.  Development of these models will
   require interplay between molecular embryologists,
   developmental toxicologists, and biomathematicians,
   and is currently in  its initial stages.
126
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                                                                               NHEERL FY95 ANNUAL REPORT
                                                                        REPRODUCTIVE TOXICOLOGY DIVISION
The ability of chemicals to mimic or interfere with the
 function of the endocrine system during reproductive
 development has been a focal point of the divisional
 research  program  for  nearly  15  years,  but  the
 environmental significance of the program took on new
 importance in the 1990s with reports of declining sperm
 counts in humans over the last four decades; apparent
 increased incidence of tumors with an endocrine basis
 (testicular, breast, and prostatic); findings of increased
 occurence and severity of endometriosis in  primates
 exposed to dioxin; and reports of a variety of effects in
 fish, reptiles, birds, and sea mammals in areas where the
 environment   has    been   contaminated    with
 endocrine-disrupting chemicals.

Much of the focus on endocrine-disrupting chemicals has
 been on those chemicals  that mimic the action of the
 female sex hormone estrogen (the so-called environmental
 estrogens).  Some have questioned whether the potency
 and prevalence of environmental estrogens can account for
 the plethora of  effects being attributed  to endocrine
 disruption in different populations of exposed humans and
 wildlife species. The endocrine disrupter issue expanded
 well beyond the previous focus on environmental estrogens
 with  RTD's  recent findings concerning p.p -DDE  and
 vinclozolin.

 * p,p -ODE: RTD scientists reported that the major
   and  persistent  DDT  metabolite  p.p.'-DDE  has
   surprisingly potent  ability to bind to the androgen
   receptor  and  block  the  action  of  endogenous
   androgens in  the  body  (Kelce  et  al.).    The
   concentration necessary to displace 50% of synthetic
   androgen  from its  receptor was only one order of
   magnitude higher than  that necessary for a clinically
   used anti-androgenic drug.  Perinatal exposure of rats
   to p,p'-DDE  delayed  the  onset  of puberty and
   prolonged the retention of thoracic nipples in  male
   offspring—effects  consistent  with the  proposed
   mechanism of action.
*•  Vinclozolin:  RTD  researchers  demonstrated  that
   metabolites of this fungicide inhibit binding of the
   androgen receptor to response elements on DNA
   (Gray et al. "Developmental effects"; Wong et al.).

RTD research into endocrine disruption also included
study of the effects of dioxin.

*•  Exposure of rats and hamsters early
   in the third trimester of pregnancy  '
   to  single dioxin  doses as low  as
   l/Jg/kg   permanently   reduced
   accessory sex gland weight and production of sperm
   in male offspring in the absence of any evidence of
   maternal  toxicity  (Gray  et   al.  "Reproductive
   morphology and function"; Gray et al. "Exposure to
   TCDD"). Interestingly, the effects on sperm counts
   were most severe when ejaculated counts were
   obtained.  The reductions were less severe in the
   epididymis,  and almost nonexistent when testicular
   sperm production  was  assessed.   These  results
   indicate  that the primary developmental effect is
   clearly post-testicular and point to the epididymis as
   a primary target.
*  In the female offspring of rats and hamsters, RTD
   scientists  observed  a  number  of unusual  and
   previously reported  effects,  including a  delay  in
   puberty, partial clefting of the phallus, abnormalities
   of the vagina, and difficulties in mating.

Collectively, these findings  heighten our concern over
the  noncancer  health  effects  of  this  ubiquitous
environmental contaminant, as noted in the draft Dioxin
Risk Assessment.
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REPRODUCTIVE TOXICOLOGY DIVISION
Endometrios/s is a painful reproductive disorder affecting
nearly five million women  annually.  Recently,  it was
reported that primates exposed nearly a decade ago to
dioxin had dose-related increases in incidence and severity
of endometriosis.   Unfortunately,  there are few animal
models for study of causes of endometriosis.

> To  help  fill this  void,  we  developed  a surgically
  induced model of endometriosis in the mouse based
  upon  earlier work in a rat  model (Cummings and
  Metcalf).  The mouse was  selected because of its
  known sensitivity to dioxin, but difficulties created by
  the small size of available uterine implants had to be
  overcome and the model verified. In this model, slices
  of  the uterus  were  sutured  to  the  intestinal
  mesenteries  and examined  for growth  in  the
  presence or absence of an estrogen.   In  control
  females,  the implants  survived and grew to  be
  fluid-filled sacs within three weeks of surgery. In the
  absence  of  estrogen  (via  ovariectomy)   or  its
  supplementation  (by silastic implants), the implants
  responded as expected from  other animal models
  (i.e., their growth was estrogen-dependent).

The model is now being used to investigate the effects
of 2,3,7,8-tetrachlorodibenzo-f>-dioxin (TCDD) on the
growth of endometriotic implants.
One way to bridge the gap between species in extrapolating
data is to use a parallelogram approach with animal data
obtained from in vivo and in vitro models, and comparable
human data derived from an analogous in vitro  system.
Predictions can then  be made about what might be
expected in humans exposed in vivo.

*•  RTD  scientists  were  able  to  characterize the
   expression  patterns  for  the arylhydrocarbon (Ah)
   receptor and its binding partner ARNT in human
   embryonic  palate  shelves  (Abbott,  Probst et al.).
   Both AhR and ARNT are expressed throughout the
   developing  palate,  as  well  as  numerous  other
   embryonic tissues. This accomplishment helps build
   the basis for extrapolation of animal and in vitro test
   data  for TCDD to humans and contributes to the
   understanding of the role of the Ah  receptor in
   normal development.
#Future Effects: This year, quantitative PCR (porynwase chain
reaction, a technique in which mRNA from cells is amplified millions
of times to Identify genes with low expression levels) is being used
to establish the expression of the respective mRNAs in both control
and exposed palates.  Additional work is under-way to evaluate a
novel hypothesis for the marked synergism noted when developing
palates are exposed simultaneously to glucocorticoids and TCDD.
interaction with glucocorticoids & important because of the rote
that they play as a trophic factor in normal development and
because a variety of chemicals and environmental stimulations can
elevate the levels of this hormone in the blood by activating adrenal
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                                                                                NHEERL FY95 ANNUAL REPORT
                                                                         REPRODUCTIVE TOXICOLOGY DIVISION
 In response to concerns raised by several epidemiologi-
 cal studies on adverse reproductive  outcomes from
 disinfectant by-products, RTD developed a comprehen-
 sive  research  strategy in  1993 that  consists of the
 following three basic components:

 •  Hazard identification studies
 •  Mechanism of action studies
 •  Development  of biomarkers of effect
 Haloacetic acids  formed during disinfection of water by
 chlorination induce embryotoxicity and reproductive toxicity
 in laboratory animal models.

 *• RTD scientists, in conjunction with ECD  scientists,
   completed  a  Quantitative  Structure  Activity
   Relationship (QSAR) study with a series of mono-, di-,
   and tri- halo (bromo-, chloro-,  iodo-, and fluoro-)
   acetic acids using an in vitro  mouse whole embryo
   culture system (Richards and Hunter).  These studies
   showed  that  lipophilicity  (log  P)  and electronic
   properties (e lumo) were important determinants of
   the ability to induce neural tube defects. The results
   are being used to prioritize testing in in vivo models.

 The potential health effects of  bromoacetic acids are
 becoming increasingly important because these acids are
 formed  at relatively high  levels  in  source  waters
 containing bromide ion. Very little information on the
 toxicity of brominated acetic acids is in the literature.
In the area of male reproductive effects, RTD scientists
observed that short-term exposure to dibromoacetic
acid alters sperm morphology and motility in adult male
rats (Under et al.). These findings were followed up
with dose-and time-course studies, in which the effects
were observed to  occur in the  absence  of  other
systemic effects and to persist at the highest dose levels
long after cessation of  exposure.   Significantly, fused
sperm (a rare finding in reproductive toxicity studies)
were found at doses as low as 50 mg/kg.
•$":• Future  Effects: This  information will likely  affect the
establishment of the MCL for bromoacids and provide novel
markers for studies of mode of action as well as for studies of
biomarkers in highly exposed human populations.
   RTD scientists collaborated with the cancer bioassay
   program in ECD to evaluate reproductive function in
   male   rats   receiving   chronic   exposure   to
   bromodichloromethane  and chloral  hydrate. The
   results showed a significant impairment  in sperm
   motility for the former  at a dose level (39 mg/kg)
   which, at least after one year of exposure, was not
   associated with increased tumor incidence (Klinefelter
   et al.).
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NHEERl FY95 ANNUAL REPORT
REPRODUCTIVE TOXICOLOGY DIVISION
        Improvements In Reproductive Toxlcity Test Methods
To cooperate with the development of internationally
harmonized toxicity testing guidelines,  EPA has been
revising noncancer  (including multigeneration) testing
guidelines. In addition to including endpoints sensitive to
disruption by chemicals that alter the function of the
endocrine system, more sensitive measures of gamete
production and function are also being incorporated into
the guidelines.

Newly  incorporated  endpoints for sperm motility and
morphology assessments require an understanding of the
relationship between motility and fertility for use in the risk
assessment process.

*  RTD scientists developed a rodent model in which
   sperm  motility  and  fertilizing ability could be
   evaluated in the same animal. This model was applied
   after acute  exposure  to o/pho-chlorhydrin  that
   produced  graded  decrements  in  sperm  motion
   endpoints  in   both   uterine   and   epididymal
   spermatozoa as measured by computer-aided semen
   analysis (Slott et al.). Analysis of the results using both
   linear and logistic regression  showed that uterine
   sperm were more sensitive than epididymal sperm to
   the  effects of this  model toxicant, and  that the
   combination  of  epididymal  and   uterine  sperm
   endpoints produced the best statistical model for the
   prediction   of  fertility   from   sperm   motion
   characteristics.
RTD scientists demonstrated and characterized the
potential impact of acute toxicant exposure on female
reproduction in hamsters exposed to the fungicide
carbendazim   during   fertilization  (Zuelke   and
Perreault).   Zygote   morphology   and   zygote
chromosomes were evaluated after both in vivo and
in  vitro exposures.  Immunoflouresce  microscopy
demonstrated chemically-induced abnormalities of
fertilization (altered meiotic spindle, multiple female
pronuclei,  and fragmented polar bodies),  while
chromosome analysis confirmed that these alterations
are  associated   with   abnormal   chromosome
partitioning  (aneuploidy).   The  zygotic  effects
correlated well with previously reported abnormal
pregnancy  outcomes  after the  same treatment.
These results show that the fertilization process can
be  severely affected  by a single  exposure,  with
profound effects on  developmental potential, and
demonstrate the utility of in vitro fertilization assays in
toxicology.
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                                                                               NHEERL FY95 ANNUAL REPORT
                                                                        REPRODUCTIVE TOXICOLOGY DIVISION
To alleviate criticisms of No Observed Adverse Effect
 Level (NOAEL)-based risk assessments for noncancer
 endpoints, RTD completed analysis of a large database
 of standard developmental toxicity bioassay results to
 determine  the   feasibility  of  implementing  the
 "benchmark dose" (BMD) approach.

 In the BMD approach, statistical dose response models
 are used to calculate a preset level of risk near the low
 end of the observable range, along with the 95% lower
 confidence limit on that value.  This approach has the
 multiple advantages of using more of the experimental
 data, of producing consistent potency calculations across
 different  studies  and  endpoints,  and  of  making  it
 unnecessary to repeat studies that fail to determine a
 NOAEL (Barnes et al.).

 While the BMD models have generally been developed to
 handle quanta/ (yes or no) data that derive from many
 experiments, many other parameters  are measured on
 graded scales (i.e., continuous variable) such as effects on
 body weight, motor activity, or serum enzyme levels.

 * RTD recently showed how BMDs for reduced fetal
   weight (often the most sensitive indicator of response
   in developmental toxicity studies) could be obtained
   and what effect levels were similar, on average, to
   traditionally determined NOAEL (Kavlock, Allen et
   al.).

 One disadvantage of the NOAEL is that better study designs
 (large sample sizes, more dose groups, greater statistical
 power)  can only yield more conservative risk estimates,
 and, therefore, better experiments are in fact discouraged.
 However, because current testing guidelines  have been
 optimized within  resource and  technical  constraints to
 generate  NOAELs, it is important to determine  how
 experimental design might be modified to take advantage
 of the strengths of the BMD approach.
*•  RTD scientists  performed simulation  analyses to
   determine the impact of study design (sample size
   and dose  spacing) on BMD calculations.   These
   analyses showed that optimal results were obtained
   with designs that contained two nonzero responding
   dose groups, with one dose  preferably near the
   estimated risk level (Kavlock, Schmid et al.). Designs
   with only one positive dose group yielded results with
   considerably wider (and hence more conservative)
   confidence levels.  We also showed that sample sizes
   half those normally used were nearly  as good for
   calculating the BMD. Largely as result of this body of
   research, the Agency is beginning to accept the BMD
   as  a replacement for the NOAEL in establishing
   Reference Doses (RfDs) and  Reference Concen-
   trations (RfCs)    for noncancer  health effects, as
   evidenced by  1995  risk  assessments for methyl
   mercury and boric acid.

The revised 1996 Cancer Risk Assessment Guidelines
have  adopted a variation of the BMD approach as an
option  in  the dose-response  assessment of  some
carcinogens.
                 11>e BHE5 approach adds this Important
                  analysis to risk assessment study design, but
              several years before sufficient experience and'
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NHEERL FY95 ANNUAL REPORT
REPRODUCTIVE TOXICOLOGY DIVISION
                                                             'xtures
Exposures in the real world are seldom to individual
chemicals, and risk assessments must often factor in
contact with multiple chemicals through multiple routes
of exposure.

In general, the additivity concept is  adopted to make
predictions of how combinations of chemicals might act.
However,  inadequate experimental work exists to verify
additivity assumptions beyond examining how simple binary
combinations of chemicals might interact.

*• RTD scientists published a major study that reported
   the results of factorial design of the  interactions of
   three  chemicals  on   developmental   outcomes
   (Narotsky, Weller et al.). This study employed three
   chemicals    (heptachlor,   trichloroethylene,  and
   diethylhexylphthlate) known  to  be developmental
   toxicants that occur together frequently at Superfund
   sites. Individual dose-response data were reported in
   a companion  paper (Narotsky and Kavlock) that
   resulted from a  multidisciplinary effort  with the
   Neurotoxicology Division.
The interaction study investigated whether individual
effects would be additive  or nonadditive across a
wide range of dose levels (30-fold difference between
the high and low dose).  Five levels of each chemical
were combined with the other chemicals to yield a
design of 125 dose groups  involving nearly  1500
pregnant rats.  The study allowed for alternative,
more efficient, designs within the main body.  The
main effects observed in the combination study were
consistent with known effects of the individual agents.
Of the nine endpoints examined,  six had statistically
significant two-way interactions  (some synergistic,
some antagonistic), but no three-way interactions
were detected.
 future Effects: The study  points out the difficulties of
         design, execution,  and  interpretation  of such
                              to explore alternative
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                                                                                              NHEERL FY95 ANNUAL REPORT
                                                                                      REPRODUCTIVE TOXICOLOGY DIVISION
 Table 38. RTD Issues and Accomplishments Overview
  DEVELOPMENT OF BBDR MODELS
  How are biologically based dose response (BBDR)
  models helpful for assimilating relevant data and
  testing model derived hypotheses?
 •   Tested predictions from computer model of pharmacokinetics, nucleotide pool
    biosynthesis, and cell cycle kinetics on rat model.

 •   Demonstrated that maternal administration of 5-FU produced fetal anemia: uncovered
    new insights and alternate modes of action for 5-FU.
  How does methanol inhalation produce birth
  defects in mice?
    Completed work on toxicity of formic acid in embryos exposed in vitro.

    Described patterns of cell death in rat and mouse embryos exposed to methanol.

    Accumulated evidence to support relevancy of mouse model to potential effects in
    humans exposed to methanol.

    Accumulated evidence to support relevancy of mouse model to potential effects in
    humans exposed to methanol in environment that is not expected to cause buildup of
    formate levels in blood.
  How may quantitative dose-response modeling in
  developmental toxicity be advanced through use
  of mechanistic data in risk assessment?
  ENDOCRINE DISRUPTION
 •   Proposed an Embryologically Based Dose Response (EBDR) model that is likely to be
    generically applicable across chemicals and instructive to findings across species.
  How may concern over possible breadth of
  chemicals responsible for endocrine disruption in
  exposed human and wildlife populations be
  addressed?
 •   Found p,p -DDE to have surprisingly potent ability to block endogenous androgens in
    the body.
 *   Demonstrated that metabolites of vmclozolin inhibit binding of androgen to DNA
    response elements.

 •   Found that low doses of dioxin permanently reduce accessory sex gland weight and
    production of sperm in abscence of maternal toxicity.
  How may animal models for study of the cause of
  endometriosis be advanced?
    Successfully developed surgically induced model of endometriosis in mice.
  How may data extrapolation models be developed
  without using in vitro data?
    Characterized expression patterns for Ah receptor and ARm in human embryonic
    palate shelves.
 REPRODUCTIVE EFFECTS OF DRINKING WATER BY-PRODUCTS
                                                   RTD AcccofTfiplishments
 How may continuing concern over disinfection by-
 products, embryotoxicology and reproductive
 toxicology be addressed?
•   Showed that lipophilicity and electronic properties were important determinants of
    ability to induce neural tube defects.
 How may information on toxicity of brominated
 acetic acids be advanced?
•   Observed that short term exposure to dibromoacetic acid alters sperm morphology and
    motility in adult male rats. Fused sperm found at low doses.
 IMPROVEMENTS IN REPRODUCTIVE TOXICITY TEST METHODS
 How may more sensitive measures of gamete
  production and function be included in testing
  guidelines?
    Developed and applied rodent model for evaluating sperm motility and fertility in same
    animal.

    Demonstrated and characterized potential effect on female reproduction after acute
    exposure to toxicant carbendazim.
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NHEERL FY95 ANNUAL REPORT
REPRODUCTIVE TOXICOLOGY DIVISION
 IMPROVEMENTS IN NONCANCER DOSE-RESPONSE ASSESSMENT
 Issue
RTD Acccomplishments
 How may NOAEL-based risk assessment be applied
 to noncancer endpoints?
    Determined feasibility of implementing "benchmark dose" (BMD) approach.
    Demonstrated how BMDs could be obtained for reduced fetal weight and showed
    comparison to traditionally determined NOAELs.

    Performed simulations to show how to design studies to obtain optimal results from
    BMD approach.
 DEVELOPMENTAL TOXICITY OF COMPLEX MIXTURES
 Issue
RTD Acccompiishments
 What experimental work exists to verify
 assumptions of additivity concepts?
*   Published results of largest and most comprehensive study of additivity concept for
    developmental toxicity.
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                                                        'U.S. Government Printing Office: 1996—750-001/41043
                                                                                                                        161

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