United States
Environmental Protection
Agency
Health Effects
Research Laboratory
Research Triangle Park NC 27711
Research and Development
EPA/600/S9-86/030 May 1987
&EPA Project Summary
Environmental Epidemiology:
The Importance of Exposure
Assessment
This project summary presents an
overview of a 1985 symposium on ex-
posure measurement and evaluation
methods for epidemiology cospon-
sored by the American Chemical Soci-
ety (ACS) and the United States Envi-
ronmental Protection Agency (EPA).
Entitled: "Environmental Epidemiol-
ogy: The Importance of Exposure
Assessment," the symposium was or-
ganized by the ACS' Division of Envi-
ronmental Chemistry, and the EPA's
Health Effects Research Laboratory.
Held in Chicago on September 8-13,
1985, at the 190th ACS national meet-
ing, the symposium presented papers
by more than fifty distinguished scien-
tists representing academia, govern-
ment and industry in the U.S., Europe
and Africa.
After a brief assessment of the need
for such a symposium and a statement
of its intent, this project summary iden-
tifies the subject material and the affili-
ation of the authors. The symposium
proceedings have been published and
their availability is described in the
paragraph immediately below.
This Project Summary was devel-
oped by EPA's Health Effects Research
Labaoratory, Research Triangle Park,
NC, to announce key findings of the
research project that is fully docu-
mented in a separate report of the same
title (see Project Report ordering
information at back).
Introduction
Epidemiology studies are a valuable
tool for assessing the effects of chemi-
cal exposure in humans. While they
cannot directly prove a cause-and-effect
relationship, they can demonstrate an
association between environmental ex-
posure to chemical(s) and observed
health effects in the exposed groups.
The strength of the association demon-
strated depends on how accurately ex-
posure of the groups can be assessed.
Unfortunately, most of the exposure
measurement and assessment work
currently being conducted is of limited
value for use in epidemiology studies;
rather, current exposure research is di-
rected towards developing methods for
detecting toxic chemicals in biological
samples (as opposed to living people)
or demonstrating that specific source
results in exposure (but not quantifying
that exposure). The purpose of the sym-
posium is to bring together epidemiolo-
gists, chemists, and mathematical
modelers so that they can gain insight
into each other's needs and capabilities,
thus resulting in research projects that
will allow the exposure of subjects in
epidemiologic studies to be more accu-
rately assessed. This progress in epi-
demiology is essential to enable scien-
tists to elucidate the risk of chemical
exposure incurred by human beings
without the uncertainty of interspecies
extrapolation.
Epidemiology studies are also impor-
tant in the regulatory process because
the results are necessary to elucidate
the risk of human chemical exposure in-
curred by human beings without the un-
certainty of interspecies extrapolation.
Because the EPA is required to develop
regulations under six separate legisla-
tive acts, these studies are usually con-
ducted to provide information for esti-
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mation of risk of exposure through a
given route or from a specific source.
Case-control and cohort studies can
provide a quantitative estimate of
health risk association with various en-
vironmental exposures, but it is often
difficult to assess relevant exposures
for individuals, because retrospective
epidemiologic studies require estimates
of past exposure which must be made
in light of current information. While it
is important to fully understand the
sources, routes, and extent of exposure
of individuals to environmental toxi-
cants, obtaining such knowledge about
the population included in an epidemi-
ology study may not be practical and
may not be achievable in all cases.
Prospective studies can be designed in
which exposure measurements are in-
cluded as part of the study, but these
studies are generally not feasible be-
cause of the high costs of following a
cohort for a long period to determine
associations between exposure and an
observed health effect.
It is important that the exposure data
collected for epidemiologic studies be
relevant and appropriate for both the
study design and regulatory needs. The
accurate measure or assessment of ex-
posure is paramount because random
misclassification of exposure for study
participants can only bias the outcome
of the study toward one or no associa-
tion between exposure and disease.
Most epidemiologic studies have as-
sumed that exposure to a contaminant
is an adequate surrogate of the dose. A
major limitation of past studies has
been lack of information on dose, e.g.,
the amount of the contaminant of
metabolite in body tissue or the amount
that interacts with the target organ or
tissue. Biologic markers of cumulative
dose would assist in improving the sen-
sitivity of epidemiologic studies, and
should be considered, whenever possi-
ble, to supplement the data collected on
exposure to environmental contami-
nants.
Symposium Papers and
Contributors
Chapter in Proceedings
Section I: Use of Biological
Monitoring to Assess Exposure
1. Detection of Aflatoxin BI Guanine
Adducts in Human Urine Samples
from Kenya, Lars O. Dragsted,
Johnston Wakhisi, and Herman
Autrup
2. Assessment of Human Exposure
to Chemicals Through Biological
Monitoring, Alfred M. Bernard and
Robert R. Lauwerys
3. The Monitoring of Exposure to
Carcinogens by the GC-MS Deter-
mination of Alkylated Amino Acids
in Hemoglobin and of Alkylated
Nucleic Acid Bases in Urine, Peter
B. Farmer, David E. G. Shuker, Eric
Bailey
4. Determining DNA Adducts by Elec-
trophore Labeling-GC, floger W.
Giese
5. Quantification of Tissue Doses of
Carcinogenic Aromatic Amines,
Paul L. Skipper, Matthew S.
Bryant, and Steven R. Tannen-
baum
Section II: Epidemiologic
Considerations for Assessing
Exposure
6. The Feasibility of Conducting Epi-
demiologic Studies of Populations
Residing Near Hazardous Waste
Disposal Sites, Gary M. Marsh and
Richard J. Cap/an
7. Feasibility Study to Relate Arsenic
in Drinking Water to Skin Cancer in
the United States, Julian B. Andel-
man and Margot Barnett
Section III: Health and
Exposure Data Bases
8. Use and Misuse of Existing Data
Bases in Environmental Epidemi-
ology: The Case of Air Pollution,
Peter Gann
9. Opening and Controlling Access to
Medicare Data, Glenn J. Martin
10. Drinking Water Quality Data Bases,
Nancy W. Wentworth, James W.
Westrick, and Kaiwen K. Wang
11. The FDA Total Diet Study Program,
Pasquale Lombardo
12. Overview of EPA Major Air Data
Bases, David W. Armentrout
13. National Database on Body Bur-
den of Toxic Chemicals, Philip E.
Robinson, Cindy R. Stroup, Anna
S. Hammons, M. Virginia Cone,
C. Donald Powers, Maria/ice
Ferguson, and Herman Kraybill
14. Broad Scan Analysis of Human
Adipose Tissue from the EPA FY 82
NHATS Repository, John S. Stan-
ley, Kathy E. Boggess, John E.
Going, Gregory A. Mack, Janet C.
Remmers, Joseph J. Breen, Fred-
erick W. Kutz, Joseph Carra, and
Philip E. Robinson
Section IV: Assessment of
Exposure to Environmental
Contaminants For
Epidemiologic Studies
Part One: Air Exposures
15. Results from the First Three Sea-
sons of the TEAM Study: Personal
Exposures, Indoor-Outdoor Rela-
tionships, and Breath Levels ol
Toxic Air Pollutants Measured for
355 Persons in New Jersey, Lance
A. Wallace, Edo D. Pellizzari, Ty D.
Hartwell, Charles M. Sparacino,
Linda S. Sheldon, and Harvey
Zelon
16. Inhalation Exposures in Indoor Air
to Trichloroethylene from Shower
Water, Julian B. Andelman, Amy
Couch, and William W. Thurston
Part Two: Water and
Occupational Exposures
17. Drinking Water'Characteristics and
Cardiovascular Disease in a Cohort
of Wisconsin Farmers, Elaine
Zeighami, Gunther F. Craun, and
Charlotte A. Cottrill
18. Empirical Estimation of Exposure
in Retrospective Epidemiologic
Studies, Charles E. Lawrence and
Philip R. Taylor
19. Evaluation of Lead Exposures in
the Environment and Their Contri-
bution to Blood Levels in Children,
Daniel Greathouse
20. The Use of Industrial Hygiene Data
in Occupational Epidemiology,
Robert F. Herrickand. Larry J. Elliot
List of Contributors and
Affiliations
Julian B. Andelman, Graduate School of
Public Health, University of Pitts-
burgh, Pittsburgh, PA 15261.
David W. Armentrout, PEI Associates,
Inc., 11499 Chester Road, Cincinnati,
OH 45246.
Herman Autrup, Laboratory of Environ-
mental Carcinogenesis, Fibiger Insti-
tute, 70 Ndr. Frihavnsgade, DK-2100,
Copenhagen, Denmark.
Eric Bailey, MRC Toxicology Unit, Medi-
cal Research Council Laboratories,
Woodmansterne Road, Carshalton,
Surrey, SMS 4EF, England.
Margot Barnett, Graduate School of
Public Health, University of Pitts-
burgh, Pittsburgh, PA 15261.
Alfred M. Bernard, Faculty of Medicine,
Unit of Industrial and Medical Toxi-
cology, Catholic University of(
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Louvain, Clos Chapelle-Aux-Champs,
BP 30.54, B-1200, Brussels, Belgium.
Kathy E. Boggess, Midwest Research In-
stitute, 425 Volker Boulevard, Kansas
City, MO 64110.
Joseph J. Breen, Office of Toxic Sub-
stances, U.S. Environmental Protec-
tion Agency, 401 M Street, S.W.,
Washington, DC 20460.
Matthew S. Bryant, Department of Ap-
plied Biological Sciences, Massachu-
setts Institute of Technology, Cam-
bridge, MA 02139.
Richard J. Caplan, Department of Bio-
statistics, Graduate School of Public
Health, University of Pittsburgh, Pitts-
burgh, PA 15261.
Joseph Carra, Office of Toxic Sub-
stances, U.S. Environmental Protec-
tion Agency, 401 M Street, S.W.,
Washington, DC 20460.
M. Virginia Cone, Science Applications
International Corporation, 300 South
Tulane Avenue, Oak Ridge, TN 37830.
Charlotte A. Cottrill, Epidemiology Sec-
tion, Health Effects Research Labora-
tory, U.S. Environmental Protection
Agency, 26 West St. Clair Street,
Cincinnati, OH 45268.
Amy Couch, Graduate School of Public
Health, University of Pittsburgh, Pitts-
burgh, PA 15261.
Gunther F. Craun, Epidemiology Sec-
tion, Health Effects Research Labora-
tory, U.S. Environmental Protection
Agency, 26 West St. Clair Street,
Cincinnati, OH 45268.
Lars 0. Dragsted, Laboratory of Envi-
ronmental Carcinogenesis, Fibiger In-
stitute, 70 Ndr. Frihavnsgade, DK-
2100, Copenhagen, Denmark.
Larry J. Elliott, Industrial Hygiene Sec-
tion, Industrywide Studies Branch, Di-
vision of Surveillance, Hazard Evalua-
tions and Field Studies, National
Institute for Occupational Safety and
Health, 4676 Columbia Parkway,
Cincinnati, OH 45226.
Peter B. Farmer,.MRC Toxicology Unit,
Medical Research Council Laborato-
ries, Woodmansterne Road, Carshal-
ton, Surrey, SM5 4EF, England.
Marialice Ferguson, Science Applica-
tions International Corporation, 300
South Tulane Avenue, Oak Ridge, TN
37830.
Peter Gann, Department of Family and
Community Medicine, University of
Massachusetts Medical School, 55
Lake Avenue North, Worcester, MA
01605.
Roger W. Giese, Department of Medici-
nal Chemistry, College of Pharmacy
and Allied Health Professions, North-
eastern University, 360 Huntington
Avenue, Boston, MA 02115.
John E. Going, Midwest Research Insti-
tute, 425 Volker Boulevard, Kansas
City, MO 64110.
Daniel Greathouse, Hazardous Waste
Engineering Research Laboratory,
U.S. Environmental Protection
Agency, 26 West St. Clair Street,
Cincinnati, OH 45268.
Anna S. Hammons, Science Applica-
tions International Corporation, 300
South Tulane Avenue, Oak Ridge, TN
37830.
Ty D. Hartwell, Research Triangle Insti-
tute, P.O. Box 12194, Research Trian-
gle Park, NC 27709.
Robert F. Herrick, Industrial Hygiene
Section, Industrywide Studies
Branch, Division of Surveillance, Haz-
ard Evaluations and Field Studies, Na-
tional Institute for Occupational
Safety and Health, 4676 Columbia
Parkway, Cincinnati, OH 45226.
Frederick C. Kopfler, Health Effects Re-
search Laboratory, U.S. Environmen-
tal Protection Agency, 26 West St.
Clair Street, Cincinnati, OH 45268.
Herman Kraybill, National Cancer Insti-
tute (retired), 17708 Lafayette Drive,
Olney, MD 20832.
Frederick W. Kutz, Office of Toxic Sub-
stances, U.S. Environmental Protec-
tion Agency, 401 M Street, S.W.,
Washington, DC 20460.
Robert R. Lauwerys, Faculty of
Medicine, Unit of Industrial and Medi-
cal Toxicology, Catholic University of
Louvain, Clos Chapell-Aux-Champs,
BP 30.54, B-1200, Brussels, Belgium.
Charles E. Lawrence, Laboratory of
Statistics and Computer Sciences,
Wadsworth Center for Laboratories
and Research, New York State De-
partment of Health, Room C-323,
Albany, NY 12201.
Pasquale Lombardo, Division of Chemi-
cal Technology, Center for Food
Safety and Applied Nutrition, Food
and Drug Administration, 200 C
Street, S.W., Washington, DC 20204.
Gregory A. Mack, Battelle Columbus
Laboratories, 505 King Avenue,
Columbus, OH 43201.
Gary M. Marsh, Center for Environmen-
tal Epidemiology, A416 Crabtree Hall,
Graduate School' of Public Health,
University of Pittsburgh, Pittsburgh,
PA 15261.
Glenn J. Martin, Health Care Financing
Administration, Bureau of Data Man-
agement and Strategy, Office of Infor-
mation Resources Management,
G-A-2 Meadows East Building, 6325
Security Boulevard, Baltimore, MD
21207.
Edo D. Pellizzari, Research Triangle In-
stitute, P.O. Box 12194, Research Tri-
angle Park, NC 27709.
C. Donald Powers, Science Applications
International Corporation, 300 South
Tulane Avenue, Oak Ridge, TN 37830.
Janet C. Remmers, Office of Toxic Sub-
stances, U.S. Environmental Protec-
tion Agency, 401 M Street, S.W.,
Washington, DC 20460.
Philip E. Robinson, Office of Toxic Sub-
stances, U.S. Environmental Protec-
tion Agency (TS-798), 401 M Street,
S.W., Washington, DC 20460.
Linda S. Sheldon, Research Triangle In-
stitute, P.O. Box 12194, Research Tri-
angle Park, NC 27709.
David E.G. Shuker, MRC Toxicology
Unit, Medical Research Council Labo-
ratories, Woodmansterne Road, Car-
shalton, Surrey, SM5 4EF, England.
Paul L. Skipper, Department of Applied
Biological Sciences, Room 56-313,
Massachusetts Institute of Technol-
ogy, Cambridge, MA 02139.
Charles M. Sparacino, Research Trian-
gle Institute, P.O. Box 12194, Re-
search Triangle Park, NC 27709.
John S. Stanley, Midwest Research In-
stitute, 425 Volker Boulevard, Kansas
City, MO 64110.
Cindy R. Stroup, Office of Toxic Sub-
stances, U.S. Environmental Protec-
tion Agency (TS-798), 401 M Street,
S.W., Washington, DC 20460.
Steven R. Tannebaum, Department of
Applied Biological Sciences. Massa-
chusetts Institute of Technology,
Cambridge, MA 02139.
Philip R. Taylor, Cancer Prevention
Studies Branch, Division of Cancer
Prevention and Control, National Can-
cer Institute, Blair Building, Bethesda,
MD 20892.
William W. Thurston, Graduate School
of Public Health, University of Pitts-
burgh, Pittsburgh, PA 15261.
Johnston Wakhisi, Department of
Surgery, University of Nairobi,
Nairobi, Kenya.
Lance Wallace, U.S. Environmental Pro-
tection Agency (RD-680), 401 M
Street, S.W., Washington, DC 20460.
Kaiwen K. Wang, Office of Drinking
Water (WH-550), U.S. Environmental
Protection Agency, 401 M Street,
S.W., Washington, DC 20460.
Nancy W. Wentworth, Office of Re-
search and Development (RD-680),
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U.S. Environmental Protection
Agency, 401 M Street, S.W., Washing-
ton, DC 20460.
James J. Westrick, Technical Support
Division (ODW), U.S. Environmental
Protection Agency, 26 West St. Clair
Street, Cincinnati, OH 45268.
Elaine A. Zeighami, Health Effects and
Epidemiology Group, Oak Ridge Na-
tional Laboratory, Building 4500-S,
F-256, Oak Ridge, TN 37831.
Harvey Zelon, Research Triangle Insti-
tute, P.O. Box 12194, Research Trian-
gle Park, NC 27709.
The EPA authors Frederick C. Kopfler and Gunther F. Craun are with the
Health Effects Research Laboratory, Research Triangle Park, NC 27711.
The complete report, entitled "Environmental Epidemiology: The Importance
of Exposure Assessment," (Order No. PB 87-132 866/AS; Cost: $24.95,
subject to change) will be available only from:
National Technical Information Service
5285 Port Royal Road
Springfield. VA 22161
Telephone: 703-487-4650
The EPA authors can be contacted at:
Health Effects Research Laboratory
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
United States
Environmental Protection
Agency
Center for Environmental Research
Information
Cincinnati OH 45268
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