Risk Assessment,
Management Communication
A Guide to Selected Sources
C OIV! r\/l U N IC A TIO N
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niSK Mssessrnent,
Management, Communication PRA°GTEE,5JYON
DALLAS, TEXAS
A Guide to Selected Sources
COMIVIUNICATION
Office of Information
Resources Management
and
Office of Toxic Substances
.- -x
March 1987
'••".<#
V
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FOREWORD
The mission of the Environmental Protection
Agency is the protection of public health and
the environment through adequate management of
adverse risk. To accomplish this effectively
we must keep abreast of the continually expand-
ing literature on risk assessment, risk
management, and risk communication. I believe
this document with its wealth of sources and
its periodic updates contributes significantly
to this objective.
A. James Barnes
Deputy Administrator
U.S. Environmental Protection Agency
111
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ACKNOWLEDGMENTS
The cooperation and interest of many at EPA have made this Guide of risk
information. It is the result of those who generously shared with us their ideas and
gave their time to this extensive effort to collect a spectrum of material of potentially
wide appeal.
We express our thanks and appreciation to everyone in and outside of EPA who con-
tributed to this project. We are especially indebted to the following:
Loretta A. Marzetti, Office of Information Resources Management, who sensed the
need for this Guide, for her direction, encouragement, and enthusiasm throughout.
Betty Heydon, Office of Information Resources Management, for typing and proofing
of the manuscript, her imaginative formatting ideas, and her sustained dedication and
energy from the beginning t« the end of the task.
Sandra Gill, Washington Information Center, for her unstinting assistance and coopera-
tion in preparing this LaserJet printed report.
Reviewers of the draft:
Derry Allen, Office of Policy, Planning, and Evaluation
Donald Barnes, Office of Toxic Substances
Daniel P. Beardsley, Office of Policy, Planning and Evaluation
Gary J. Burin, Office of Pesticide Programs
James M. Conlon, Office of Water
Lewis S.W. Crampton, National Institute for Chemical Studies, Charleston, West
Virginia
Lee DeHihns, Region 4, Atlanta
Allen Jennings, Office of Policy, Planning and Evaluation
Edwin Johnson, Office of International Activities
Frederick Kutz, Office of Research and Development
Kenneth B. Malmberg, Office of Air and Radiation
Peter Preuss, Office of Research and Development
Thomas W. Purcell, Office of Water
Patricia Roberts, Office of General Counsel
Randall Shobe, Office of Research and Development
Deborah Taylor, Office of the Administrator
William P. Wood, Office of Research and Development
Craig Zamuda, Office of Solid Waste and Emergency Response
EPA Headquarters librarians for searching assistance:
Emma McNamara, Head Librarian
Michelle Lee, Chief Reference Librarian
Mary Hoffman, Reference Librarian.
Geraldine D. Nowak, Office of Toxic Substances
Richard J. Johnson, Office of Information
Resources Management
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// a man will begin with
certainties, he shall end in
doubts; but if he will be con-
tent to begin with doubts he
shall end in certainties.
— Francis Bacon
vn
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CONTENTS
FOREWORD iii
ACKNOWLEDGMENTS v
INTRODUCTION 1
RISK-ASSESSMENT 5
General Perspective 7
Assessment Guidelines 17
Quantitative Risk Assessment and 21
Pharmacokinetics
Methods of Estimating and Measuring Risk 33
Health Risks 47
General 47
Cancer 51
Genotoxicity and Reproductive Effects 59
Neurotoxicity 89
Ecological Risks 93
Corporate Risk Assessment 99
Policy 101
Legal Aspects 103
Uses of Risk Assessment 105
Bibliographies and Other Sources Ill
EPA Information Systems Inventory 115
Office of Pesticide Programs 117
Office of Radiation Programs 121
Office of Research and Development 128
Office of Toxic Substances 130
RISK MANAGEMENT 13 3
General Perspective 135
Policy 153
Legal Aspects 161
Health Risks 165
Economic Analysis 169
Corporate Risk Management 171
Bibliographies and Other Sources 173
RISK COMMUNICATION 175
Informing the Decision-Maker 177
Informing the Public 179
Informing the Worker 185
OTHER SOURCES 191
Organizations 193
Meetings and Conferences 197
Education 199
ix
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APPENDIX A 201
EPA Regional Network for Risk Assessment/ 203
Risk Management
APPENDIX B 205
EPA Libraries 207
APPENDIX C 219
Databases Searched 217
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This Guide has been prepared and reviewed
by the U.S. Environmental Protection
Agency (EPA). Due to the rapidly expand-
ing field of risk information, EPA cannot
guarantee that all relevant sources are
cited. Publication does not signify that
the contents reflect the views of EPA or
that EPA endorses the coverage and scope
of the subject matter as comprehensive,
complete, and appropriate.
XI
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INTRODUCTION
The mission of the U.S. Environmental Protection Agency (EPA) is to protect public
health and the environment from unreasonable risk. This is attained through
regulatory actions that involve the complex processes of risk assessment, risk
management, and risk communication.
EPA has adopted many of the regulatory goals for risk assessment and risk
management that were clarified in 1983 by the National Academy of Sciences in Risk
Assessment in the Federal Government: Managing the Process. The increasing impor-
tance and use of risk assessment as the basis for regulatory decisions is largely respon-
sible for the rapid expansion of information on risk.
This Guide directs the reader to a wide spectrum of sources of information which
addresses the basic and fundamental principles and issues of risk assessment, risk
management, and risk communication. Other related sources are also cited. The Guide
is designed to assist EPA, other Federal, State, and local government agencies, and the
private sector in locating and building on existing knowledge of risk. It also serves to
identify experts and organizations within and outside EPA who are involved in the
areas of risk assessment, management, and communication.
General Perspective
The Guide is intended to assist the reader in selecting material of interest to expand
his or her knowledge and understanding of basic and important issues related to en-
vironmental risk. Broad coverage is given to the subject and includes areas such as
policy, principle, theory, practice, research, methodology, and problems created by
scientific uncertainty and false perceptions. In addition, basic and fundamental studies
from other fields, such as the behavioral sciences and pharmacology are included.
These areas have potential applicability to an increased understanding of the prin-
ciples underlying risk assessment and management at the EPA.
The Guide also includes a section on other sources of information such as
bibliographies, organizations, meetings and conferences, and course work that support
risk research and education. The Appendixes list EPA Regional risk coordinators, EPA
libraries, and computerized databases that were searched in preparing this Guide.
Subject areas excluded from this Guide are: (1) hazardous waste (The EPA Library's
Hazardous Waste Collection and Database," a PC-based software system, adequately
covers this specific source of risk. It is cited in the section on Risk Assessment: Bibli-
ographies and Other Sources); (2) risks associated with specific chemicals except when
the chemical is used to illustrate a principle; and (3) abatement technology.
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The information included in the Guide was obtained from:
• scientific and technical papers and reports resulting from EPA support of re-
search and development
• books, reports, conference proceedings
• journal articles from commercial databases covering the last 10 years
(Appendix C)
• the EPA Information Systems Inventory of databases and modeling systems
• the EPA Catalog of Library Holdings.
How To Use The Guide
The Contents page illustrates the organization and content of the material. Oc-
casionally there are definitions and scope notes added at the beginning of each section
and subsection to help further delineate the contents.
Bibliographic references are arranged alphabetically by title within each topical
area. Many of the references cited address topics beyond those in the subsection in
which they have been listed. For example, the subsections of "Legal Aspects" and
"Policy" in the "Risk Management" section contain overlapping discussions. Likewise,
the subsections of the Risk Assessment section also contain overlapping material.
While references were placed in subsections which appeared to be given the most
weight, the reader is encouraged to examine other possibly related subsections. Most of
the cited references have an abstract. All abstracts are supplied by the author. Each
entry includes at least: title, author, source, and date of publication. In addition, the
author's affiliation, sponsoring and performing organization, keywords, report number,
book call number, and EPA library location may also be present.
Bibliographic citations, retrieved from computerized files are accompanied by a
code for the file from which they were retrieved. For example, the Dialog information
system contains a database called Enviroline which is coded "ENVL". Electronically
accessed citations contained in the Guide include the information and basic format
provided by the database service and the code that is added to identify the database
source.
How To Obtain Cited Documents
The EPA network of libraries can assist EPA staff in obtaining documents from its
collection of materials or that of another library's through interlibrary loan. Each
cited reference includes sufficient information for the librarian or reader to easily lo-
cate the document in a library or from a publisher or distributor.
The double asterisk (**) before the title indicates that the document is in the EPA library
system. However, because the libraries continually add to their collections, it is advisable to
search the local index or to consult the librarian for all documents you wish to read.
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Supplements To The Guide
The last ten years of the literature have been surveyed inclusive of the September
1986 update for databases that were searched. To keep up with changes and new
developments in this dynamic area, the Headquarters Library will produce a quarterly
current awareness bulletin to supplement the Guide. It will highlight newly published
and retrospective literature, as well as meetings, conferences, courses, and workshops.
If you would like to share documents and other sources of risk information with our
readers, please send these to:
EPA HQ Library - PM-211A
Risk Update
401 M Street, S.W.
Washington, D.C. 20460
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RISK
ASSESSMENT
. IS THE SCIENTIFIC PROCESS THAT EVALUATES THE POTENTIAL FOR
OCCURRENCE OF ADVERSE EFFECT.
General Perspective 7
Assessment Guidelines 17
Quantitative Risk Assessment and Pharmacokinetics 21
Methods of Estimating and Measuring Risk 33
Health Risks 47
General 47
Cancer 51
Genotoxicity and Reproductive Effects 59
Neurotoxicity 89
Ecological Risks 93
Corporate Risk Assessment 99
Policy 101
Legal Aspects 103
Uses of Risk Assessment 105
Bibliographies and Other Sources 111
EPA Information Systems Inventory 115
Office of Pesticide Programs 117
Office of Radiation Programs 121
Office of Research and Development 128
Office of Toxic Substances 13ft
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GENERAL PERSPECTIVE includes cross-media approach,
de minimis risk, and uncertainty in assessment.
Analysis of Actual Versus Perceived Risks
Proceedings of the Society for Risk Analysis. Volume 1
Covello, Vincent T., National Science Foundation; Flamm,
W. Gary, Food and Drug Administration; Rodricks, Joseph V.,
Environ Corp.; Tardiff, Robert G., National Academy of Sciences (eds.)
Corporate Source: Society for Risk Analysis
New York, Plenum, 1986
388p., illustrated, 0-306-41397-3
Type Document: Series: Society for Risk Analysis, Volume 1
Keywords: Risk Analysis; Comparative Study; Estimation
Methodology; Actual Versus Perceived
Research has shown that technical experts and nonexperts differ substantially in their
risk estimates of health, safety, and the environment. Risk estimates by technical ex-
perts are more closely aligned with annual fatality rates than estimates by nonexperts.
The contributors to this volume clarify the issue by presenting selected cases that rep-
resent some of the most important aspects and dimensions of risk: voluntary vs.
involuntary; low vs. high probability of occurrence, exposure, and effects; and high vs.
low health, safety, or environmental consequences.
Source of Abstract: Publisher
**Anatomy of Risk
Rowe, William D.
New York, Wiley, 1977
Type Document: Series: Wiley series on systems engineering
and analysis
Keywords: Technology Assessment; Risk; Decision-Making
Call Number: T174.5.R68
EPA Libraries: EHA Rl; EIA R2; EJB HQ; EJE OTS; EKB RTP;
EKD Athens; ELB Cine; EGA R8; ERA R9; ERB Las Vegas; ESB Corv
"Assessment and Management of Chemical Risks
Based on a Symposium Sponsored by the Division of Chemical Health
and Safety at the 184th Meeting of the American Chemical Society,
Kansas City, Missouri, Spetember 12-17, 1982
Rodricks, Joseph V.; Tardiff, Robert G.
Washington, DC, American Chemical Society, 1984
Type Document: Series: American Chemical Society Symposium
Series 239
Keywords: Animal Toxicity; Epidemiology; Chemical Safety
sessment; Dose-Response Evaluation; Human Exposure Assessment;
Methodologies of Risk Assessment; Decision-Making; Risk Management
Call Number: RA 1199.A77.1984
EPA Libraries: EJB HQ; EIA R2; EJE OTS; ELA R5; ELB Cinn; ELD Duluth
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"Background Information Document: (Integrated Risk Assessment):
Final Rules for Radionuclides
Variant Title: Radionuclides, Background Information
Document for Final Rules
Corporate Source: U.S. Environmental Protection Agency.
Office of Radiation Programs.
PEI Associates Washington, DC. U.S. Environmental
Protection Agency, Office of Radiation Programs, 1984.
2 v.-.lll., maps; 28 cm.
Keywords: Radioisotopes-Environmental aspects -United
States; Radioactive pollution-United States
(GPO)
"Chemical Risk: A Primer
ACS Report, Dec 84 (12) Assn Report
Chemical Risk Assessment is defined as an attempt to identify in a qualitative sense,
and then to quantify scientifically the risk associated with a given exposure. A dis-
tinction is made between risk assessment and risk management. Major components of
risk assessment include chemical structure, solubility bioaccumulation, and
transformation. Toxicity estimation techniques include clinical, epidemiological,
animal, and test tube studies. Uncertainties inherent in testing schemes and in estimat-
ing chemical exposure are appraised. (1 Diagram, 1 Graph) (ENVL)
"Elements of Risk Assessment
Goldstein, Bernard
U.S. EPA, Washington, DC, EPA 1985
Note: Risk Assessment Conference, March 18, 1985
EPA Libraries: EJB HQ
Call Number: EPAX 8602-0014
"Environmental Risk Analysis for Chemicals
Conway, Richard A.
New York: Van Nostrand Reinhold, 1982, 558pp
ISBN 0-442-21650-5
(ENVL)
"Environmental Risk Assessment
Whyte, Anne V.; Burton, Ian (eds)
New York: John Wiley and Sons, 1980 159pp
ISBN 0-471-27701-0
(ENVL)
8
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"Fundamentals of Risk and Insurance. 2nd Ed.
Waughan, Emmett J.; Elliott, Curtis Miller
Santa Barbara, Wiley, 1978
Type Document: Series: Wiley-Hamilton Series in Risk and
Insurance
Keywords: Risk (Insurance)
Call Number: HG 8051.E478 1978
EPA Libraries: EKA R4
"Hazard Assessment Philosophy: A Regulatory Viewpoint
Akerman, James W.; Coppage, David L.
EPA
Presented at American Fisheries Society Analyzing the Hazard Evaluation Process
Conf, New Hampshire, Aug 14-18, 78, P68 (6) Technical report: Provisions of the
Federal Insecticide, Fungicide, and Rodenticide Act of 1972 contain guidelines for the
registration and hazard evaluation of chemical substances. Information on pesticide
use and aquatic toxicity is needed to evaluate nontarget hazards. Basic required tests
include a 96 HR LC50 for one coldwater and one warmwater fish species. A 96 HR
LC50 for shrimp and crab species, and embryo-Larvae lifecycle tests. (1 Reference, 2
Tables) (ENVL)
**Managing Environmental Risks
Aim, A
The Environmental Forum 4(1):12-14: 1985
HMTC Risk assessment is an important tool for setting environmental control priorities
because it estimates potential substance toxicity with human exposure to obtain a risk
level. Environmental control priorities, however, are currently based on specific legis-
lation rather than risk assessment, causing unnecessary health risks and wasted efforts
on the part of EPA. For example, instead of placing a high priority on radiation
posing the greatest health risk, Federal regulation has given priority to radiation caus-
ing little risk. In turn, EPA addressed the legislation dealing with the low risk radia-
tion and did not address high risk radiation. Risk assessment estimates need to be used
in the legislative process, and analytical tools need to be continually developed to
provide guidance on regulatory decisions. (NLM)
"Measurement of De Minimis Risk
(Final rept.)
Chmelynski, H. J.; Lehrman, D.; Goldin, D.; Beal, S.
Faucett (Jack) Associates, Inc., Chevy Chase, MD
Sponsor: Cohen (S.) and Associates, McLean, VA; Office of
Radiation Programs, Washington, DC
Report No.: JACKFAU-84-311-3 Apr 85 124p
Prepared in cooperation with Cohen (S.) and Associates, McLean, VA
Contract No.: EPA-68-02-3853
PB85-197325/XAB
This study attempts to determine the existence of 'de facto de minimis' threshold as it
is revealed by examining government activity with respect to low-level risks that are
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clearly visible and accurately measured. The study was restricted to the examination
of government activity because society's concerns are reflected in risk-management
decisions made by the government sector. Risk which are accepted by individuals be-
cause of the associated benefits derived from accepting the risk were considered poor
candidate for revealing the current level of 'de minimis.' This effectively eliminated
from consideration most occupational risks, which are often accepted based on cost-
benefit criteria. (NTIS)
**No-Risk Society
Aharoni, Yair
Chatham, NJ, Chatham House, 1981
Type Document Series: Chatham House Series on Change in
American Politics
Keywords: Social Security; Welfare State; Risk; Insurance
Call Number: HD7091.A4
EPA Libraries: EJB HQ
Perceiving Environmental Quality. Research and Applications
Craik, Kenneth H., Univ of California at Berkeley;
Zube, Ervin H., Univ of Massachusetts (eds.)
New York, Plenum, 1986
324 p, illustrated 0-306-36309-7
Type Document: Series: Environmental Science Research, Vol.9
Keywords: Risk Assessment Methodologies
Contributors from several fields discuss research needs and methodological issues in as-
sessing various environments— residential and institutional, scenic and recreational,
air, water and sound. Research strategies are suggessed.... This book should remain a
useful reference for several years.
Source of Abstract: Perceptual and Motor Skills
"Pollution Abatement Resulting in Cross Media Impacts: Radiation
Schoen A
AEC
Presented at EPA Poll Control Tech Assessment Conf,
Columbus, OH, May 1-3, 74, p 47 (3)
Survey report: While in most environmental legislation one form of media is considered
without the commensurate concern for the impact of stresses imposed on other media,
the nature of atomic energy legislation deals with the total technology and the total
concept of control and regulation. All media and all sources of environmental impact
are considered equally, and regulations apply to the entire developing technology.
(ENVL)
10
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Problems in Making Decisions About Hazard
Hayward, GM
Cambridge Univ. (England). Dept. of Engineering
Report No.: CUED/F-CAMS/TR-209-1981
1981 53p
Also pub. as ISSN-0309-765X
Country of Publication: United Kingdom
PB82-114497
Widespread concern is frequently expressed about the public management of hazards.
It is argued here that this arises from severe problems of assessment, of acceptability
and of government decision-making. These problems are discussed and approaches to
handling them are proposed. It is argued that hazards should be assessed by multiple
dimensions of severity and that acceptability should depend on the balance between
the assessed hazard and all other costs and benefits of an activity and of the alterna-
tive options, but that the 'natural' approach to decision making by government bodies
is to try to establish norms for each factor separately. It is suggested that the political
processes of public hazard management could be improved by using formal decision-
aiding methods, of which Decision Analysis appears to be currently the most suitable.
(NTIS)
Research Needs for Dealing with Uncertainty in Risk Analysis
(Final report)
Little (Arthur D.), Inc, Cambridge, MA
Sponsor: National Science Foundation, Washington, DC. Div.
of Policy Research and Analysis
Report No.: NSF/PRA-83043 Sep 83 74p
Contract Number: NSF-PRA84-40855
Type Document: Conference Proceeding
PB84-150127
Discussions are summarized from the workshop held to: (1) identify major generic
problems of uncertainty in the risk analysis process; (2) summarize methods and ap-
proaches that could be used to deal with these problems; and (3) suggest areas and
topics warranting further research to address those problems that are not adequately
treated by existing methods. The workshop format is described and participants are
listed. Thirteen areas warranting further research are identified: (1) estimation of low
probabilities; (2) dealing with model uncertainty; (3) representation of uncertainty; (4)
description of risks and behaviors; (5) responses to rare events; (6) data collection
strategies; (7) resource allocation to hazards; (8) use of experts in risk analysis; (9) role
of incentives in risk management; (10) ethics for imposition; (11) retrospective review
of risk studies; (12) long-range risk analysis; and (13) natural experiments. These re-
search topics are ranked and compared in terms of both importance and feasibility.
(NTIS)
11
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"Risk Analysis and Decision Processes: The Siting of Energy Gas
Facilities in Four Countries
Kunreuther, Howard; Linnerooth, Joanne
Corporate Source: International Institute for Applied Systems Analysis
New York, Springer-Verlag, 1983
Keywords: Liquified Natural Gas Industry; Decision Making;
Case studies; Liquified Petroleum Gas Industry; Risk
Call Number: HD9581.2.L572K86 1983
EPA Libraries: EJA R3; ERA R9
**Risk Analysis Controversy: An Institutional Perspective:
Proceedings of a Summer Study on Decision Processes and
Institutional Aspects of Risk Held at IIASA, Laxenburg,
Austria, 22-26 June 1981
Kunreuther, Howard; Ley, Eryl V.
Corporate Source: International Institute for Applied
Systems Analysis
New York, Springer-Verlag, 1982
Keywords: Technology Assessment; Risk
Call Number: T174.5.R554 1982
EPA Libraries: EKE OAQPS-RTP
**Risk and Culture: An Essay on the Selection of Technical
and Environmental Dangers
Douglas, Mary; Wildovsky, Aaron B.
Berkely, Univ. of California Press, 1982
Type Document: Book
Keywords: Risk; Culture
Call Number: H91.D68 1982
EPA Libraries: EJA R3; EJB HQ; ERA R9
**Risk Assessment
Mechanical Engineering 106: 21-59, Nov 84
Bibliography, Flow Diagram, Illustrated Diagram
Source: Applied Science and Technology Index, 1985
Risk Assessment and Environmental Benefits Analysis
Runge, Carlisle F.
Univ of Minnesota
Natural Resources J.. Jul 83, V23, N3, P683 (14)
Although cost-benefit analysis is widely used to weigh environmental policy
alternatives, it faces two types of uncertainty: regulatory and scientific. The former
12
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involves the absence of information concerning the supply of and demand for a given
level of quality, while the latter involves a lack of data on thresholds defining health
standards. The shortcomings of cost-benefit analysis are illustrated by its use in the
Clean Air Act of 1977. (32 references). (ENVL)
"Risk Assessment as a Subjunctive Process
(Paper presented at the 44th Military Operations Research Symposium
at Vandenberg AFB, Dec 5, 1979)
Strauch, Ralph E.
Santa Monica, CA, Rand Corp, 1980
Type Document: Conference paper
Keywords: Decision Making; Risk
Call Number: HD30.23.58x
EPA Libraries: EKE OAQPS-RTP
"Risk Assessment of Environmental Hazard
Kates, Robert William; Clark Univ.
Corporate Source: Scientific Committee on Problems of the
Environment (Scope)
New York, J. Wiley, 1978
Type Document: Series: Scope Report: 8
Keywords: Environmental Health; Environmental Monitoring
Intl Council Scientific Unions Report, 1978 (132)
Special report: The state of the art of coping with environmental risks was examined,
and the process of environmental risk assessment was explored. Risk assessment is a
small but essential part of the process of coping with environmental hazard. A risk
assessment methodology was detailed, including hazard identification techniques and
theory, risk estimation methods and theory, and social evaluations of risks through cost
benefit and other techniques. Trends and attitudes in the scientific research, media,
public opinion, and statistical evaluation of environmental risk assessment were
detailed. A case study showing three views of a nuclear reactor safety study was
explored. (17 Graphs.Numerous References, 18 Tables)
Call Number: RA566.K37
EPA Libraries: EIA R2; EJE OTS; EKB RTP; EKC GBreeze;
EKD Athens; ELB Cinn; ESB Corv
**Risk in the Technological Society
Hahenemser, Christoph; Kasperson, Jeanne X.
Corporate Source: American Association for the Advancement
of Science
Boulder, Colo, Westview Press, 1981
Keywords: Technology Assessment; Risk
Based on a symposium which was held at the 1980 American Association for the Ad-
vancement of Science National Annual meeting in San Francisco, California, January
3-8
Call Number: T174.5.R57
EPA Libraries: EH A Rl; EJE OTS
13
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"Risk: Man Made Hazards to Man
Cooper, MG
Oxford, Clarendon Press, 1985
Type Document: Series: Wolf son College Lectures: 1984 Keywords: Environmental
Health — Addressess, essays, lectures; Health Risk Assessment; Toxicology; Hazardous
Substances
Call Number: RA566.R57 1985
EPA Libraries: EJA R3
"Societal Risk Assessment: How Safe is Safe Enough?
Schwing, Richard C.; Albers, Walter A.
General Motors Corp. Research Labs
New York, Plenum Press, 1980
Type Cocument: Proceedings
Keywords: Technology Assessment; Risk
Notes: Proceedings of an International Symposium held Oct 8-9, 1979 at the General
Motors Research Labs, Warren, Michigan and sponsored by the Labs.
EPA Libraries: EKB RTP; ELB Cinn
Call Number: Tl74.5.56
"State of the Environment: An Assessment at Mid-Decade (Controlling
Cross-Media Pollutants)
Conservation Foundation Report, 1984, p 319 (46)
Pollutants can move from one medium to another, causing damage in each. Federal
statutes and programs are designed to control pollutants as if they remain in the same
medium. This narrow focus can undermine the effectiveness of environmental laws. A
cross-media approach to pollutant control has four dimensions paralleling the stages of
pollution control: release from a source, waste management, cycling in the
environment, and exposure of people and ecosystems. The need to control toxics that
move among media is encouraging a more integrated approach to environmental
management. Policy focus must shift from limiting releases into a single medium to
reducing risk from a source, pollutant, or geographic area. Controls would encourage
changing products or processes, and segregating or recycling wastes. (4 Diagrams, 1
Graph) (ENVL)
"State of the Environment: An Assessment at Mid-Decade (Risk
Assessment and Risk Control)
Conservation Foundation Report, 1984, P261 (57)
Environmental managers are presently emphasizing risk assessment, the process of
determining adverse consequences from the use of a technology or some other action.
Hazard occurrence probability is estimated, and types of hazards posed are defined.
Almost all such assessments are plagued by inadequate data. Adequate toxicity data
are not available for the majority of chemicals now in use. As a result, analysts often
do not know whether taking regulatory action on a chemical will increase or reduce
risk. This lack of exposure and hazard data influences policy, as many policy deci-
sions must be based on assumptions. (2 Diagrams, 1 Graph, 2 Tables) (ENVL)
14
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"Technological Risk Assessment
Ricci, Paolo F.; Sagan, Leonard A; Whipple, Chris
The Hague, Boston, M. Nijhoff, 1984
Type Document: Series: NATO ASI Series, Series E, Applied
Sciences, No. 81
Keywords: Technology Assessment; Health Risk Assessment;
Bibliography
Proceedings of the NATO Advanced Study Institute of Technology
Risk Assessment, ERICE, Sicily, Italy, May 20-31, 1981
Call Number: T174.5.N37 1981
EPA Libraries: ELB Cine.
"Toxic Materials Risk Assessment: A Practical Guide
Camougis, G.
Pollution Engineering 17:50-7, Aug 85
Diagram
Source: Applied Science and Technology Index, 1985
*Toxicity Testing: Strategies to Determine Needs and Priorities
National Research Council
Washington, DC, National Academy Press, 1984, 382 pp.
**The 1985 Washington Conference on Environmental and Health
Risk Assessment
Co-sponsored by Inside EPA Weekly Report and The Center
for Energy and Environmental Management Oct 28-29, 1985,
Radisson Mark Plaza Hotel, Alexandria, VA
Notes: Areas of discussion include EPA risk assessment guidelines, Office of Science
and Technology Policy initiatives, ecological risk assessment, Food and Drug Ad-
ministration risk assessment, assessing exposure risks, Research, industry risk
assessments, hazardous wastes, report on the Kanawha Task Force, communicating risk.
EPA Libraries: EJB HQ
15
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ASSESSMENT GUIDELINES
"Department of Health and Human Services. National Institutes of
Health, Guidelines for Research Involving Recombinant DNA Molecules
Federal Register Vol. 51, No. 88, May 7, 1986
p.16958-16985
"Environmental Protection Agency, vruidelines for Carcinogen Risk
Assessment Final
Federal Register. Vol. 51, No. 185, Sep 24, 1986,
p.33992-34003 References: 29
"Environmental Protection Agency Proposed Guidelines for Carcinogen
Risk Assessment; Request for Comments
Federal Register. Vol.49, No. 227, Nov. 23, 1984
p.46294-46301
"Environmental Protection Agency. Guidelines for Estimating
Exposures. Final
Federal Register. Vol. 51, No. 185, Sep 24, 1986,
p.34042-34054
** Environmental Protection Agency Proposed Guidelines for Exposure
Assessment; Request for Comments
Federal_Register. Vol.49, No. 227, Nov. 23, 1984
p.46304-46312
"Environmental Protection Agency. Guidelines for the Health
Assessment of Suspect Developmental Toxicants Final.
Federal_Reeister. Vol. 51, No. 185, Sep 24, 1986,
p.34028-34040. References: 69
"Environmental Protection Agency Proposed Guidelines for the Health
Assessment of Suspect Developmental Toxicants and Request for Comments
Federal Register. Vol.49, No. 227, Nov. 23, 1984 (FR)
p.46324-46331
Environmental Protection Agency. Guidelines for the Health
Risk Assessment of Chemical Mixtures. Final.
Federal Register. Vol. 51, No. 185, Sep 24, 1986
p.34014-34025. References: 40
17
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Protection Agency Proposed Guidelines for the Health
Risk Assessment of Chemical Mixtures and Request for Comments;
Notice
Federal Register. Vol.50, No. 6, Jan. 9, 1985
p.1170-1176
"Environmental Protection Agency. Guidelines for Mutagenicity
Risk Assessment Final.
Federal Register. Vol. 51, No. 185, Sep 24, 1986,
p.34006-34012 References: 21
"Environmental Protection Agency Proposed Guidelines for
Mutagenicity Risk Assessment; Request for Comments
Federal Register. Vol.49, No. 227, Nov. 23, 1984
p.46314-46321
**EnvironmentaI Protection Agency. Office of Pesticide Programs.
Hazard Evaluation Division. Standard Evaluation Procedures:
1. Honey Bee - Contact LD50
PB86-154580/REB
EPA 540/9-85-002
2. Honey Bee - Toxicity of Residues on Foliage
PB86-129244/REB
EPA 540 19-85-003
3. Wild Mammal Toxicity Test
PB86-129251/REB
EPA 540/9-85-004
4. Acute Toxicity Test for Freshwater Invertebrates
PB86-129269/REB
5. Acute Toxicity Test for Freshwater Fish
PB86-129277/REB
EPA 540/9-85-006
6. Avian Single-Dose Oral LD50
PB86-129285/REB
EPA 540/9-85-007
7. Avian Dietary LC50 Test
PB86-129293/REB
EPA540/9-85-008
8. Acute Toxicity Test for Estuarine and Marine Organisms
(Estuarine Fish 96-Hour Acute Toxicity Test)
PB86-129301/REB
EPA 540/9-85-009
9. Acute Toxicity Test for Estuarine and Marine Organisms
(Shrimp 96-hour Acute Toxicity Test)
PB86-129319/REB
EPA 540/9-85-010
18
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10. Acute Toxicity Test for Estuarine and Marine Organisms
(Mollusc 96-hour Flow-Through Shell Deposition Study)
PB86-129327/REB
EPA 540/9-85-011
11. Acute Toxicity Test for Estuarine and Marine Organisms
(Mollusc 48-hour Embryo Larvae Study)
PB86-129335/REB
EPA 540/9-85-012
12. Hydrolysis Studies
PB86-129343/REB
EPA 540/9-85-013
13. Aqueous Photolysis Studies
PB86-129350/REB
EPA 540/9-85-014
14. Aerobic Soil Metabolism Studies
PB86-129368/REB
EPA 540/9-85-015
15. Soil Photolysis Studies
PB86-129376/REB
EPA 540/9-85-016
16. Soil Column Leaching
PB86-129384/REB
EPA 540/9-85-017
17. Teratology Studies
PB86-129392/REB
EPA 540/9-85-018
18. Oncogenicity Potential (Guidance for Analysis and
Evaluation of Long Term Rodent Studies)
PB86-129400/REB
EPA 540/9-85-019
19. Toxicity Potential (Guidance for Analysis and
Evaluation of Subchronic and Chronic Exposure Studies)
PB86-129418/REB
EPA 540/9-85-020
20. Magnitude of the Residue: Crop Field Trials
PB86-129426/REB
EPA 540/9-85-021
21. Ecological Risk Assessment
PB86-247657
EPA 540/9-85-001
Note: These EPA guidance documents are used to evaluate pesticide registration data sub-
mitted to the Agency and are used in conjunction with the appropriate Pesticide Assessment
and other Agency Guidelines.
**Environmental Protection Agency. Office of Pesticide Programs
Hazard Evaluation Division. Pesticide Registration Guidelines
Subdivision D, Product Chemistry
EPA 540/9-82-018; NTIS PB83-153890
19
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Subdivision E, Hazard Evaluation: Wildlife & Aquatic Organisms
EPA 540/9-82-024; NTIS No. PB83-153908
Subdivision E, Addendum
EPA 540/9-85-152; NTIS No. PB86-248176
Subdivision F, Hazard Evaluation: Human & Domestic Animals
EPA 540/9-82-025; NTIS No. PB83-153916
Subdivision F, Revised
EPA 540/9-84-014; NTIS No. PB86-108958
Subdivision F, Addendum
EPA 540/9-86-150; NTIS No. 86-248184
Subdivision G, Product Performance
EPA 540/9-82-026; NTIS PB83-153924
Subdivision H, Labeling For Use
EPA 540/9-82-000; (Not available from NTIS)
Subdivision I, Experimental Use Permits
EPA 540/9-82-022; NTIS No. PB83-153932
Subdivision J, Hazard Evaluation: Nontarget Plants
EPA 540/9-82-020; NTIS No. PB83-153940
Subdivision K, Exposure: Reentry Protection
EPA 540/9-84-001; NTIS No. PB85-120962
Subdivision L, Hazard Evaluation: Nontarget Insects
EPA 540/9-82-000; NTIS No. PB83-154957
Subdivision M, Biorational Pesticides
EPA 540/9-82-028; NTIS No. PB83-153965
Subdivision N, Chemistry: Environmental Fate
EPA 540/9-82-021; NTIS No. PB83-153973
Subdivision N , Addendum
EPA 540/9-86-149; NTIS No. PB86-247848
Subdivision O, Residue Chemistry
EPA 540/9-82-023; NTIS No. PB83-153981
Subdivision O, Addendum 2
EPA 540/9-86-151; NTIS No. PB86-248192
Subdivision O, Supplement 1
EPA 540/9-86-148; NTIS No. PB86-203734
Subdivision R, Pesticide Spray Drift Evaluation
EPA 540/9-84-002; NTIS No. PB84-189216
Subdivision U, Applicator Exposure Monitoring
EPA 540/9-87-127; NTIS No. PB87-133286
NTIS = National Technical Information Service, 703-487-4650
"Office of Science and Technology Policy. Chemical Carcinogens;
A Review of the Science and Its Associated Principles, February 1985.
Federal Register. Vol.50, No. 50, Mar. 14, 1985
p.10372-10442
20
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QUANTITATIVE RISK ASSESSMENT AND PHARMACOKINETICS .... includes clini-
cal and physiological pharmacokinetics, drug metabolism, acceptable daily intake (ADI),
quantitative structure-activity relationship (QSAR), dose-response relationship
**Application of Metabolic and Excretion Kinetics to Problems
of Industrial Toxicology
Piotrowski, Jerzy
Washington, DC, U.S. Government Printing Office, 1971
Type Document: Book
Keywords: Industrial Toxicology; Mathematical Models;
Biotransformation (metabolism); Pharmacokinetics
Call Number: RA1216.P56
EPA Libraries: EKB RTF RA1216.P52; ELB Cinn; ERB Las Vegas
**Applied Clinical Pharmacokinetics
Mungall, Dennis R.
New York, Raven Press, 1983
Call Number: RM301.5.A655 1983
EPA Libraries: ELB Cinn
"Approaches to Quantitative Expression of Dose Response
Gilbert, ES
Sponsoring Agency: Department of Energy, Washington, DC
NTIS/DE85013498, 16p
This paper discusses quantifying risks experienced by populations that have been ex-
posed to relatively low levels of harmful agents or substances. 15 refs. (ERA citation
10:037824) Symposium on epidemiology and health risk assessment, Columbia, MD,
USA, 14 May 1985. (NLM)
Biological Variation: The Unsolvable Problem in Quantitative Extrapolations
from Laboratory Animals and Other Surrogate Systems to Human Populations
Gillett JR
Lab. of Chemical Pharmacology, Natl. Heart, Lung, and Blood Inst., NIH, Bethesda, MD
Banbury Rep; 19:199-206 1985
The obvious objective of risk assessment is to estimate the rate of occurrence of a
given biological response at any given dose of a given substance in the human
population, or in the populations of other organisms in the environment. For many
theoretical as well as practical reasons, however, this objective is virtually
unattainable, even for compounds that are already present in the environment. One of
the difficulties in making quantitative estimates of the rate of occurrence of toxicities
21
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in the human population solely from data obtained with laboratory animals is the
heterogeneity that exists in the human population. Variations in the factors repre-
sented by each of the parts of a toxic mechanism contribute to the total variance of the
human population. The relative contributions of each of the parts may, however, vary
with the subpopulation and the the toxicant. Since for good reasons toxicity studies
are almost invariably performed with homogeneous strains of animals kept under care-
fully controlled environmental conditions, there is no way that any given strain of
animals can adequately mimic the entire human population. Nevertheless, there is no
reasonable alternative to the use of data obtained with homogeneous animal strains
together with arbitrary safety factors in making first approximations of acceptable
risks. It is essential that a consensus for an arbitrary safety factor be obtained. Since
safety factors will inevitably fail with some substances, they will never replace the
epidemiological studies and toxicity reporting programs. (12 REFS) (NLM)
**Biopharmaceutics and Clinical Pharmacokinetics: An Introduction
Notari, Robert E.
New York, M. Dekker, 1980
Type Document: Book
Note: 3rd edition, revised and expanded
Call Number: RM301.4.N67
EPA Libraries: EJE OTS
"Biopharmaceutics and Pharmacokinetics: An Introduction
Notari, Robert E.
New York, M. Dekker, 1.975
Type Document: Book
Note: 2nd edition, revised and expanded
Call Number: RM300.N.58 1975
EPA Libraries: ELB Cinn
"Clinical Pharmacokinetics: A Modern Approach to Individualized
Drug Therapy
Wartak, Joseph
New York, Praeger, 1983
Type Document: Series: Clinical Pharmacology
and Therapeutics Series V. 2
Call Number: RM301.5.W37 1983
EPA Libraries: ELB Cinn
22
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**A Conceptual Development of Quantitative Environmental Impact
Assessment Methodology for Decision-makers
Prasartseree, M
TESCO Ltd Consulting Firm, 21/13-14 Soi Sukhumvit 18, Bangkok 11, Thailand
J Environ Manage: (1982). 14(4): 301-308
Heep Copyright: Biol Abs
There are 6 factors that must be taken into account when assessing the significance of
an environmental impact arising from a project's activities, namely, impact magnitude,
prevalence, duration and frequency, risk, importance and mitigation. Current en-
vironmental impact assessment methodologies in widespread use are suited for specific
tasks of the 6 decision-making factors, but not all of them. An all-encompassing
methodology is thus a combination or modification of existing techniques which retains
strengths while eliminating weaknesses. Some entirely new concepts are introduced to
improve the required decision-making aid capabilities. (NLM)
**The Current Use of Studies on Promoters and Cocarcinogens
in Quantitative Risk Assessment
Stara, JF; Mukerjee, D; McGaughy, R; Durkin, P; Dourson, ML
Environ. Criteria Assess. Off., U.S. EPA, Cincinnati
EHP Environ. Health ersoect..: (1983). Vol 50: 359-68
CBAC Copyright: Chem Abs
A review with 63 refs. Review cocarcinogen risk assessment. Tumor promoter risk
assessment review. (NLM)
"Development of Quantitative Estimates of Uncertainty in Environmental
Risk Assessments When the Scientific Data Base is Inadequate
Cothern CR; Coniglio WA; Marcus WL
Environment International (1986). V.12: 18 pp.
Direct and brief look at the problem of how to deal with uncertainties in risk
assessments.
**Dose Dependent Toxicity
O'Flaherty ES
Univ. of Cincinnati Medical Center, Institute of Environmental Health
Comments on Toxicology. (1986). Vol. l(l):23-34
"Drug Fate and Metabolism: Methods and Techniques
Garrett, Edward R; Hirtz, Jean L.
New York, M. Dekker, 1977
Type Document: Book
Keywords: Pharmacokinetics; Drugs; Metabolism
Call Number: RS189.D78
EPA Libraries: ELB Cinn
23
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"Drug Product Design and Performance
Smolen, Victor F; Ball, LuAnn
New York, Wiley, 1984
Type Document: Series: Controlled Drug Bioavailability: VI
Keywords: Biopharmaceutics; Pharmacokinetics;
Structure-Activity Relationship ,(Pharmacology)
Call Number: RM301.4.D78 1984
EPA Libraries: ELB Cine
"Fundamentals of Clinical Pharmacokinetics
Wagner, John G.
Hamilton, Illinois, Drug Intelligence Publications, 1975
Type Document: Book
Call Number: RM301.5.W33
EPA Libraries: EKB RTP
'Fundamentals of Drug Metabolism and Drug Disposition
LaDu, Bert N; Mandel, H. George; Way E. Leong
Baltimore, William and Wilkins Co., 1971
Keywords: Pharmacokinetics; Drug Metabolism
Call Number: RM301.55.F86
EPA Libraries: EJE OTS; ELB Cinn; EMA R6 RM300.F83
"Fundamentals of Risk Assessment
Whipple, Chris G.
Environmental Law Reporter 16: Aug 86, 10190-5
"The Importance of Metabolite Identification in Quantitative Risk Estimation
Stevens, JT; Sumner, DD
Agric. Div., Ciba-Geigy Corp., Greensboro
J. Toxicol.. Clin. Toxicol.: Vol 19, ISS 6-7, 1982, 781-805
CBAC Copyright: Chem Abs
A discussion on the relationship between xenobiotic metab. and risk assessment was
presented. Proposed mechanisms of carcinogenicity; weaknesses of risk extrapolation
and the validity of several types of model for use i" risk extrapolation are considered.
(NLM)
24
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The Importance of Pharmacokinetic and Macromolecular Events as They
Relate to Mechanisms of Tumorigenicity and Risk Assessment
Schumann, AM; Watanabe, PG; Reitz, RH; Gehring, PJ
Health Environ. Sci., Dow Chem., Midland
Toxicol. Liver: 1982, 311-31
CBAC Copyright: Chem Abs. A discussional review with 66 refs. Review phar-
macokinetics tumoriginicity, risk assessment. (NLM)
"Kinetic Data Analysis: Design and Analysis of Enzyme and
Pharmacokinetic Experiments
Endrenyi, Laszlo
New York, Plenum Press, 1981
Keywords: Rate of Chemical Reaction; Enzymes; Pharmacokinetics
Proceedings of a satellite symposium...organized in conjunction with the Xlth Interna-
tional Congress of Biochemistry, and held July 8-13, 1979 in Toronto, Canada.
Call Number: QP517.R4K56
EPA Libraries: EKB RTP
"Manual of Laboratory Pharmacokinetics: Experiments in Biopharmaceutics,
Biochemical Pharmacology, and Pharmacokinetics, with a Consideration
of Relevant Instrumental and Chromatographic Techniques
Curry, Stephen H; Whelpton, Robin
Chichester: New York, Wiley, 1982
Type Document: Book
Call Number: RM301.4.C87
EPA Libraries: ELB Cinn
"Modeling of Inhalation Exposure to Vapors: Uptake, Distribution,
and Elimination
Fisevova-Bergerova, Vera
Boca Raton, FL, CRC Press, 1983
Type Document: Book
Keywords: Asphyxiating and Poisonous Gases;
•Mathematical Models; Pharmacokinetics
Call Number: RA1245.M6 1983
EPA Libraries: EKB RTP; ELB Cinn
"New Approaches in the Derivation of Acceptable Daily Intake (ADI)
Dourson, ML
U.S. Environmental Protection Agency, Cincinnati, OH
Comments on Toxicology. (1986). Vol. l(l):35-48 (19 Refs)
25
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"Overview of Some Aspects of Quantitative Risk Assessment
Fishbein, Lawrence
Natl Center for Toxicological Research, ARK
J Toxicology & Env Health. (Sep-Nov 80). V6, N5-6, p!275(22)
Survey report: Use of data from laboratory experiments using animals to estimate the
human risk from long-term exposure to low doses of environmental carcinogens poses
numerous biological, lexicological, and statistical problems, including that of ex-
trapolating animal dose-response relations from the high-dose range, where animal test
data are available, to the low doses that humans might encounter. Different mathe-
matical models for extrapolation are described. The procedures for estimating human
risk on the basis of animal studies are evaluated. (1 graph, numerous references, 4
tables) (ENVL)
**Pharmacokinetic Basis for Drug Treatment
Benet, Leslie Z; Massoud, Neil; Gambertoglio, John G.
New York, Raven Press, 1984
Type Document: Book
Call Number: RM301.5.P46 1984
EPA Libraries: ELB Cinn.
**Pharmacokinetics
Gibaldi, Milo; Perrier, Donald
New York, M. Dekker, 1982
Type Document: Series: Drugs and the Pharmaceutical Sciences: V. 15
Note: 2nd Edition, Revised and Expanded
Call Number: RM301.5.G5 1982
EPA Libraries: ELB Cinn
Physiological Pharmacokinetics Relevance to Human Risk Assessment
Li, A.P. (Ed.)
Toxicity Testing: New Approaches and Applications in Human Risk
Assessment: Meeting, St. Louis, MO., USA. Sept. 14-15, 1983
Lutz, RJ; Dedrick, RL
XIX+280p
New York, NY, Raven Press
Illus. ISBN 0-88167-083-0; 1985. p.129-150
(NLM)
26
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**QSAR and Strategies in the Design of Bioactive Compounds:
Proceedings of the Fifth European Symposium on
Quantitative Structure-Activity Relationships,
Bad Segeberg, 1984
Seydel, JK
Weinheim, Federal Republic of Germany, VCH Verlagsgesellschaft, 1985
Type Document: Conference Proceedings
Keywords: Pharmacokinetics; Drug Design; Pharmaceutical Chemistry;
Agricultural Chemistry
Call Number: RS420.E87 1984
EPA Libraries: ELB Cinn
Quantitative Assessment of Induced Genetic Ill-Health in Humans As
a Model for Assessing Genetic Risks from Chemicals, in: Chemical
Mutagenesis, Human Population Monitoring and Genetic Risk Assessment
Newcombe, HB
Prog Mutat Res. (1982). 3: 53-62
(NLM)
Quantitative Cancer Risk Assessment Methodology Using Short-Term
Genetic Bioassays: The Comparative Potency Method
Lewtas, J.
Health Effects Research Lab., Research Triangle Park, NC
NTIS/PB86-117017, 17p
TD3: Quantitative risk assessment is fraught with many uncertainties. The validity of
the assumptions underlying the methods employed are often difficult to test or
validate. Cancer risk assessment has generally employed either human epidemiological
data from relatively high occupational exposures or animal cancer data from lifetime
rodent bioassays. Low-dose extrapolation methods are often used with the human
epidemiological data to estimate risks at lower environmental exposure levels. Scaling
factors are used with animal data to extrapolate from rodents to humans. The
problems, controversies and uncertainties associated with these methodologies has en-
couraged us to develop the concept and methodology associated with a comparative
potency method for cancer risk assessment. This comparative potency method may be
particularly appropriate for application to the quantitative cancer risk assessment of
combustion emissions. (NLM)
Same title in: Pros Clin Biol Res. V.208, 1986, P107-20
27
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"Quantitative Predictivity of Carcinogenicity for Sister Chromatid
Exchanges in Vivo
Parodi, S; Taningher, M; Zunino, A; Ottaggio, L; De Ferrari, M; Santi, L
1st. Naz. Ricerca Cancro, Univ. Genoa, Genoa
New York, Plenum, 1984
Basic Life Sci.; Vol 29A, ISS Sister Chromatid Exch., Pt. A, 1984, 409-29
CBAC Copyright: Chem Abs
The level of predictivity achieved by sister chromatid exchanges (SCEs) in vivo with
respect to carcinogenicity in rodents was examd. Oncogenic potency index (OPI) and
SCE index (SCEI) data for 59 compds. were compared. The global level of correlation
between OPI and SCEI was very significant. For a chem. subclass of arom. amines, the
correlation was much lower than for all the other compds. examd. Thus, SCE anal, can
be used as a predictive test in the assessment of tumor risk, esp. if unsuitable chem.
classes could be identified and avoided. (NLM)
"Quantitative Risk Assessment for Environmental and Occupational Health
Hallenbeck, William H.; Cunningham, Kathleen M.
Chelsea, MI, Lewis Publishers, 1986
Type Document: Book
Keywords: Risk Assessment; Environmental Health; Occupational Health
EPA Libraries: EKB HQ
"Quantitative Risk Assessment of Environmental Hazards
Brown, SL
Commission on Life Sciences, National Academy of Sciences, Washington, DC 20418
Annu Rev Public Health (1985). Vol 6: 247-67
Quantitative risk assessment may never become a rigorous scientific discipline because
of the inherent difficulties in working with highly uncertain and often controversial
data and methods, and because the predictions of risk assessment may not be subject to
validation in their most important areas of application. However, the potential
benefits of having quantitative estimates of risk may make quantitative risk assess-
ment a valuable adjunct to traditional methods for making individual and social deci-
sions about health hazards in the home, workplace, and general environment. Risk
assessment, which is the process of estimating risks to populations exposed to hazardous
agents or activities, must be distinguished from risk management, which is the process
of forming and implementing a strategy for accepting or abating the risks. To the ex-
tent possible, these two processes should be kept separate. Quantitative risk assessment
is in principle capable of estimating individual or lifetime excesses of specific health
effects from exposures to a specified hazard. These excesses may be estimated on an
absolute basis or expressed as a relative risk in comparison with the baseline risk that
would exist without exposure. An individual risk is usually expressed in terms of the
probability of developing the health effect in some time period following a specified
exposure, whereas a population risk is the overall number of effects expected in a
defined population with a defined distribution of exposure levels and patterns. The
variation of risk with time after exposure may imply a constant absolute risk, a con-
stant relative risk, or some other dependence on time, usually after a minimal latent
28
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period has elapsed. Risk estimates can rarely be made directly from observed human
data, and models for extrapolating or projecting risk estimates from the conditions of
observation to the actual conditions of exposure must be used. Dose-response are used
for extrapolating from high laboratory or occupational exposures to low exposures en-
countered more frequently in human populations. Thresholds of dose or nonlinear
dose-response relationships may be related to nonlinear pharmacokinetics prior to the
ultimate exposure of the critical organ to the proximate carcinogen or other hazardous
agent. Time-response models estimate risks for periods after exposure longer than have
been observed in epidemiologic studies. Extrapolations from experiments with
laboratory animals to humans are made difficult because of great differences in size,
lifespan, physiology, and metabolism between human and animal. (NLM)
"Quantitative Risk Assessment: Report of the Subcommittee
on Environmental Carcinogenesis, National Cancer Advisory Board
Samuels, SW; Adamson, RH
JNCI (1985). Vol 74, ISS 4: 945-51
(NLM)
"Quantitative Risk Assessment: State-of-the-Art for Carcinogenesis
Park, CN; Snee, RD
Dow Chem., Midland
Fundam ADD! Toxicol. Vol 3, ISS 4, 1983, 320-33
CBAC Copyright: Chem Abs
A review with 44 refs. of a crit. evaluation of the use of statistical models in car-
cinogenic risk assessment with emphasis on the strengths and weaknesses of current
practice. (NLM)
Radiation Induced Cancer the Methods and the Problems of Quantitative
Risk Assessment (German)
Frohlich, E
Vierteliahrsschr Naturforsch Ges Zuer: 129 (1), 1984, 21-37
(NLM)
"Ranking the Severity of Toxic Effects: Potential Applications to Risk Assessment
Hartung, Rolf
Univ. of Michigan, Dept. of Environmental and Industrial Health
Durkin, Patrick R
Syracuse .Research Corp., Center for Chemical Hazard Assessment
Comments on Toxicology. 1986. Vol. l(l):49-63 (7 REFS)
29
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"Rate-Controlled Drug Administration and Action
Struyker-Boudier, Haj
Boca Raton, FL, CRC Press, 1985
Type Document: Book
Keywords: Pharmacokinetics
Call Number: RS201.C64R37 1985
EPA Libraries: ELM Cinn
**Risk Assessment of Toxic Environmental Substances Using a
Generalized Multi-Hit Dose Response Model
Rai, Kamta; Van Ryzin, John
(California State Polytechnic Univ) and; (Rand Corp).
Presented at Siam Inst for Mathematics & Society Conf, Utah,
Jun 26-30, 78, p99 (19)
Technical report: A generalized multi-hit dose response model for assessing risks of
toxic environmental substances is presented. Biological and statistical interpretations
of the model are given. Statistical procedures for estimating model parameters and
sample properties, and for using the model in risk assessment through extrapolation to
low doses are explained. These procedures are applied to 12 sets of toxic response data
from the literature. Model performance is similar to that of the one-hit model;
however, the multi-hit dose response model is more stringent in its risk assessment. (30
references, 2 tables)
(ENVL)
**Risk Quantitation and Regulatory Policy
This vol is comprised of papers reported at the Banbury Center confertence on Risk
Quantitation and Regulatory Policy held in May 1984. The papers of Session 1, on
regulatory programs utilizing risk assessment, had the following titles: the role of
quantitative risk assessment in environmental regulations; use of quantitative risk
assessment in regulatory decision making under federal health and safety statutes; the
inevitability of risk quantitation and its potential contribution to food safety
regulation; and legal impediments to the use of risk assessment by regulatory agencies.
Papers in Session 2, on epidemiology in risk estimation, had these titles: epidemiology
and risk assessment (estimation of gastrointestinal cancer risk from asbestos in drink-
ing water and lung cancer risk from polycyclic aromatic hydrocarbons in air); ap-
proaches to the estimation of exposure in occupational epidemiology; the use of
epidemiological data for the assessment of human cancer risk; and problems in dose-
response and risk assessment (the example of asbestos). Session 3, on modeling and
extrapolation, had papers with these titles: the impact of occupational exposure pat-
terns on quantitative risk estimation; consequences of nonlinear kinetic dose-response
models in carcinogenic risk assessment; and uncertainty in risk assessment. Papers in
Session 4, on mutagenic risk in biological mechanisms, had these titles: attempts to es-
timate genetic risks caused by mutagens to later generations; and some aspects of quan-
tifying and acting upon the risks of radiation exposures. Papers in Session 5, on
toxicology and biological mechanisms, were on: carcinogenic risk assessment (a
toxicologist's view); application of model systems in pharmacokinetics; biological varia-
tion (the unsolvable problem in quantitative extrapolations from laboratory animals
30
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and other surrogate systems to human populations); potential methods to monitor
human populations exposed to carcinogens (carcinogen-DNA binding as an example);
the relevance of tumor promotion and multistage carcinogenesis to risk assessment; and
mechanistic considerations in the formulation of carcinogenic risk estimation. Papers
in Session 6, on specific case histories, had these titles: a scientific approach to formal-
dehyde risk assessment; description of a carcinogenic risk assessment used in a
regulatory proceeding (formaldehyde); human exposure estimates for hazardous waste
site risk assessment; and risk assessment and risk management of benzene by the En-
vironmental Protection Agency (EPA). Finally, papers in Session 7, on risk quantita-
tion and the dynamics of policy formulation, had these titles: United States EPA
revised interim guideline for the health assessment of suspect carcinogens; and the
changing role of risk assessment in federal regulation. (NLM)
EPA Libraries: EJB HQ; EJE OTS; EKB RTF; ELB Cinn
Call number: RA1199.R58. 1985
**Some Issues in the Quantitative Modeling Portion of Cancer Risk Assessment
Sielken, RL Jr.
Department of Statistics, Texas A&M University, College Station 77843
Reeul Toxicol Pharmacol. Vol 5, ISS 2, 1985, p!75-81
Several questions should be asked in order to determine the relevance and scientific
merit of a quantitative cancer risk assessment. Twenty such questions are formulated
here and briefly discussed. These questions are intended to identify important issues
and serve as a checklist for risk managers and developers of quantitative risk
assessments. Among the many factors involved in these questions are the carcinogenic
response, quantal response models, time to response, competing risks, model shapes,
goodness of fit, dose scale, high-to-low-dose extrapolation, consistency across different
subjects, animal-to-human extrapolation, route-to-route extrapolation, exposure dura-
tions and patterns, short-term tests, consistency with human epidemiological data,
human exposures, statistical variability impacts of assumptions and policy decisions
and value judgments, risk characterization, upper and lower bounds, and keeping pace
with scientific advances. (NLM)
"Toxicants and Drugs: Kinetics and Dynamics
O'Flaherty, Ellen J.
New York, Wiley, 1981
Type Document: Book
Keywords: Poisons; Metabolism; Mathematical Models;
Dose-Response Relationship; Pharmacokinetics; Xenobiotic Metabolism; Toxicology
Call Number: RA1216.O35
EPA Libraries: EJE OTS; EKB RTP; ELB Cinn; EMB Ada;
Translation of Pharmacokinetic/Biochemical Data into Risk Assessment
Dietz, FK; Reitz, RH; Watanabe, PG; Gehring, PJ
Adv EXP Med Biol. Vol 136B, ISS Biol. React.
Intermed.2, Chem. Mech. Biol. Eff., Pt. B, 1982, 1399-424
CBAC Copyright: Chem Abs
A review with 38 refs. Review health hazard assessment pharmacokinetics. (NLM)
31
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**Use of Quantitative Risk Assessment in Regulatory Decision Making
Under Federal Health and Safety Statutes
Hutt, Peter Barton
Coving & Burling
Type Document: Meeting Paper
EPA Libraries: EJB HQ
"The Use of Skin Penetration Data in Risk Assessment
Rodricks, JV; Turnbull, D
Environ Corp., Washington
CTFA Sci. Monogr. Ser.; Vol 2, ISS Pharmacokinet.
Top. Appl. Cosmet. Symp., 1983, 71-80
CBAC Copyright: Chem Abs
The incorporation of skin absorption data in a quant, carcinogenic risk assessment is
discussed with an example of data on D&C Red No. 19 (81-88-9). Uncertainty with
respect to extrapolation of in vitro data and in the differences in pharmacokinetics
and metab. of dermally applied and orally administered materials still exist.
EPA Libraries: EJB HQ
(NLM)
32
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METHODS OF ESTIMATING AND MEASURING RISK
**The Analysis of Actual Versus Perceived Risks
Proceedings of the Society for Risk Analysis. Vol. 1
Covello, Vincent T., National Science Foundation,
Glamm, W. Gary, Food and Drug Administration,
Rodricks, Joseph V., ENVIRON Corp.,
Tardiff, Robert G., National Academy of Sciences (eds)
Corporate Source: Society for Risk Analysis
New York, Plenum (1986)
388 p. illustrated
0-306-41397-3
Type Document: Series. Society for Risk Analysis, Vol.1
Keywords: Risk Analysis; Comparative Study; Estimation Methodology;
Actual versus Perceived
Research has shown that technical experts and nonexperts differ substantially in their
risk estimates of health, safety, and the environment. Risk estimates by technical ex-
perts are more closely aligned with annual fatality rates than estimates by nonexperts.
The contributors to this volume clarify the issue by presenting selected cases that rep-
resent some of the most important aspects and dimensions of ris; voluntary vs.
involuntary; low vs. high probability of occurrence, exposure, and effects; and high vs.
low health, safety, or environmental consequences.
Source of Abstract: Publisher
EPA Libraries: EJB HQ
Assessment of Risk from Low-Level Exposure to Radiation and Chemicals
Woodhead, Avril D.; Shellabarger, Claire J.; Pond, Virginia, Brookhaven
National Laboratory; Hollaender, Alexander, Council for Research
Planning in Biological Sciences, Inc.
New York, Plenum [1986]
542p., illustrated, Proceedings
0-306-42003-1
Type Document: Series: Basic Life Sciences, Volume 33
Keywords: Low-Level Exposure; Risk Assessment; Radiation Exposure;
Chemical Carcinogens; Exposure-Response Relationships
Researchers around the world are focusing on the effects of radiation and chemical
carcinogens, and the assessment risk involved has become an essential steppingstone in
the setting of judicious exposure standards. This volume provides vital information on
the practical aspects of assessing the risks of low-level exposure to radiation and
chemicals. The emphasis is on exposure-response relationships, particularly the
theoretical and practical similarities and differences between exposure to ionizing
radiation. Specific topics include low-level exposure effects on single cells, response
modification, effects in cell groups and animals, and monitoring human populations.
Volume 33 in the series Basic Life.
Source of Abstract: Publisher
33
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"Approach to Assessing Exposure to and Risk of Environmental Pollutants (Revised)
(Final rept)
Little, (Arthur D.), Inc., Cambridge, MA
Sponsor: Environmental Protection Agency, Washington, DC
Monitoring and Data Support Div.
Report No.: EPA/440/4-85/021 Apr 83 262p
Contract No.: EPA-68-01-3857; EPA-68-01-5949
PB85-222826/XAB'
The report describes an integrated exposure and risk methodology developed for the
U.S. Environmental Protection Agency (EPA) as part of a program to assess
exposure/risk of 65 classes of chemicals (129 'priority pollutants') in the water
environment. It provides an overview of the risk assessment process and a detailed
discussion of the analytic components of an environmental exposure and risk assess-
ment including approaches for evaluating; the environmental loadings resulting from
production, transport, use, and disposal of the chemicals; the mechanisms of pollutant
transport and transformation in environmental media and the concentrations detected;
the extent of exposure of humans and other biota; and the risk presented to exposed
populations. The methodology is intended to provide a general understanding of en-
vironmental exposure and risk assessment and to assist those who will be conducting
this type of analysis. It contains numerous examples from exposure and risk assess-
ments of 54 priority pollutants performed for EPA and a bibliography of source
materials. (NTIS)
"Approaches to Risk Assessment for Multiple Chemical Exposures
Stara, J.F.; Erdreich, L.S.
Environmental Protection Agency, Cincinnati, OH
Environmental Criteria and Assessment Office
Sponsor: Dynamac Corp., Rockville, MD
Report No.: EPA-600/9-84-008 Mar 84 288p
Prepared in cooperation with Dynamac Corp., Rockville, MD
PB84-182369
The Environmental Criteria and Assessment Office (ECAO) in Cincinnati has
developed health risk assessment methods for chronic exposure to single chemical from
a single route of exposure. Risk assessments for carcinogens associated an exposure
level with a particular incidence of cancer using a non-threshold model which is linear
at low doses. For systemic toxicants, the no-observed-adverse-effect level
(NOAEL)/Uncertainty Factor approach was used to estimate an acceptable daily intake
(ADI). In order to develop methods for assessing risk from exposure to mixtures of
chemicals, all relevant routes and all exposure durations must be considered. The basis
of the single chemical approach is constantly updated to keep pace with developments
in pharmacokinetics, species and route extrapolation, mathematical models, additivity
and interaction. These and other relevant issues were addressed and during a 20-day
workshop on 'Approaches to Risk Assessment for Multiple Chemical Exposures' held by
the U.S. Environmental Protection Agency in Cincinnati, Ohio on September 29 and 30,
1982. The workshop was attended by 50 scientists from EPA and private industry.
This document presents the results of this workshop, including presentations, critiques
and discussion for each of the 11 subtopics covered. (NTIS)
34
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**Assessment of Risks to Human Reproduction and to Development of the
Human Conceptus from Exposure to Environmental Substances
Galbraith, W.M.; Voytek, P.; Ryon, M.G.
Oak Ridge National Lab., TN
Sponsor: Environmental Protection Agency, Washington, DC
Office of Research and Development; Department of Energy, Washington, DC
Report No.: ORNL/EIS-197; EPA/600/9-82-001; CONF--8010259--Summ.;
CONF--801286--Summ.
Feb 82 165p
US Environmental Protection Agency conference on assessment of risks
to human reproduction, Atlanta, GA, 1 Oct 1980
Contract No.: W-7405-ENG-26
DE82007897
The Offices of Health Research and of Health and Environmental Assessment within
the Office of Research and Development sponsored a conference to produce a technical
document on the current status of risk assessment methodologies for teratogenic and
other reproductive effects. The conference brought together scientists knowledgeable
in reproductive biology and teratology to discuss techniques and concepts pertinent to
developing risk assessment methodologies. The document is divided into three main
subject areas: assessment of toxicity to female reproduction, assessment of toxicity to
male reproduction, and assessment of toxicity to the conceptus. There are three sup-
plemental parts: pharmacokinetics and epidemiologic considerations, which are com-
mon to all toxicological assessments, and a special section on the behavioral aspects of
sexual development. The specific areas addressed are the potential adverse effects on
the female and male reproductive systems as well as adverse effects on the developing
conceptus. A broad range of problems and effects are discussed, including infertility,
early resorption of the conceptus, and possible behavioral disorders producted by
subtle changes in the biochemical environment of the fetus. Suggestions are given for
improvement in standard toxicological protocols for evaluation of reproductive risks,
identifies new concepts and procedures that can be immediately applicable, and desig-
nates those that need further expansion and development through research. Included is
a discussion on the predictive ability of the tests in estimating risk. (ERA citation
07:051825) (NTIS)
"Biological Monitoring
Dowd, RM
Environmental Science and Technology: 2ISA; 1984
HMTC Biological monitoring is being reestablished as a method of measuring the ef-
fects of chemicals in humans or ecological systems. There are two ways to characterize
biological monitoring; indication of the level of human exposure to a chemical sub-
stance and its effect, and the measurement of nonhuman exposure to certain substances
and their effects (e.g., effect of PCBs on aquatic life). This second characterization is
being used extensively in research. One area of investigation is the bioassay of
effluents. An example is a LC50 test which quantifies the amount of effluent that will
destroy 50% of the inhabitants being tested. Chronic aquatic toxicity tests utilize the
method of nonhuman exposure, and is related to the reproduction statistics of water
species. Another area of activity is the measurement of the chemical effects in aquatic
organisms on a physiological subcellular level. The field of human biological monitor-
35
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ing has broadened because of the increased utilization of risk assessment. The Office
of Research and Development under EPA is putting a great deal of time and money
into the area, including research in field-validated bioassay techniques, toxic
treatability evaluations of specific industries, and the relationship between the ex-
posure of a person to an ambient level of a substance through food, air, or water, and
the amount concentrated in his.organs and tissues. (NLM)
Conference on the Safety Evaluation of Chemicals
Nelson N
New York University, New York, NY
CRISP/86/ES03820-01
US Dept of Health & Human Services; Public Health Service;
National Inst of Health, National Institute of Environmental
Health Sciences
CRISP Data Base National Institutes of Health
RPROJ/CRISP: Here proposed is a series of three Workshop Conferences aimed at ex-
amining new and emerging methods for safety evaluation of chemicals; these
Workshops lead to published reports in book form. These are conducted by the Scien-
tific Group on Methodologies for the Safety Evaluation of Chemicals, an international
organization sponsored by the International Programme on Chemical Safety (IPCS) of
the World Health Organization (WHO) which includes the International Labor Or-
ganization (ILO) and United Nations Environment Program (UNEP) and the Scientific
Committee on Problems of the Environment (SCOPE) of International Council of
Scientific Unions (ICSU). The Group has an international membership which en-
courages the review of difficult problems relating to methods for evaluating the ef-
fects of chemicals on human and non-human biota. These Workshops result in books
composed of commissioned, individually authored papers and a Joint Report. The first
Workshop (now available from Wiley Publishing Company) dealt with Methods for As-
sessing the Effects of Chemicals on the Reproductive Functions; the second, about to
be published, dealt with Quantitative Risk Assessment; the third, completed in August,
1983, is now in final editing and deals with Methods for Assessing the Effects of Mix-
tures of Chemicals; the fourth, completed in August 1984 is also in final editing and
covered the Predictive Value of Short-Term Tests for Non-Genotoxic Effects. Can-
didate topics are proposed by the Executive Committee of SGOMSEC and chosen in
consultation with the Sponsors. Normally, one such Workshop is held each year follow-
ing 8-10 months of preparatory writing by the invited contributors. A main objecitve
is the specific identifi-cation of research needs for the improvement of methods for
Ithe safety evaluation of chemicals. (NLM)
"Direct Mutagen Risk Assessment: The Development of Methods to
Measure Immunologic and Genetic Responses to Mutagens
Strauss GHS; Waters MD; Sandhu SS
U.S. Environmental Protection Agency, Research Triangle Park, NC
EPA symposium on short-term bioassays in the evaluation of
complex environmental mixtures, Chapel Hill, NC, 27 Mar 1984
Plenum Press, New York, NY
Report No.: CONF-8403131
Type document: Analytic of a book; Conference literature
36
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Accepting society's "addiction" to the products of industrial technology makes it our
responsibility to attempt to ascertain the adverse effects of chemical and physical
agents, according to the authors. They state that an escalating awareness of the poten-
tial and manifest severities of mutagen-related health effects confers a sense of ur-
gency on the problem of producing and utilizing relevant data for sound risk-versus-
benefit predictions and decisions. The purpose of this paper is to review their efforts
to develop methods with which to evaluate the in vivo effects of mutagen exposure in
cells taken directly from the body. (DOE)
"Environmental Assessment: Short-Term Tests for Carcinogens,
Mutagens and Other Genotoxic Agents
(Technology transfer rept.)
Trontell, Ann; Connery, Jan
Energy Resources Co., Inc., Cambridge, MA
Sponsor: Environmental Research Center, Cincinnati, OH
Report No.: EPA/615/9-79/003
Jul 79 35p
Prepared in cooperation with Health Effects Research Lab.,
Research Triangle Park, NC.
Prepared for Environmental Research Center, Cincinnati, OH
PB-300 611/1
Short-term tests have been developed to serve as rapid and relatively inexpensive pre-
dictors of a chemical's potential to cause chronic effects. These tests employ bacteria,
yeast, plants, insects, isolated mammalian cells and whole animals. Short-term tests can
detect a chemical's genotoxicity, that is, its ability to alter a cell's genetic material
(DNA). The document is organized into five sections. The first section discusses how
short-term tests can contribute to hazard assessment, while the second describes the
scientific basis and techniques of short-term tests. A general strategy for how short-
term tests can be used to detect a chemical's potential long-term toxicity is outlined in
the third section. Some program applications of short-term test research are presented
in the fourth section, and the fifth section describes some of the current research
activities. An overall perspective concludes the document. A glossary of technical
terms is provided at the end of the document along with an appendix of technical in-
formation on specific short-term tests. (NTIS)
"Environmental Methods Testing Site Project Management Plan Draft.
Fitzsimmons, Charles K.
Environmental Research Center, Univ of Nevada, Las Vagas
Nevada 98154
Cooperative Agreement No. CR812189-01
Project Officer: Shelly J. Williamson, EPA, Exposure
Assessment Division, Environmental Monitoring Systems Lab,
Las Vegas, Nevada 89114
The EPA has a need to develop and improve methods for assessing human exposure to
toxic substances to support regulations resulting from the Toxic Substances Control Act
of 1976. The Environmental Methods Testing Site project is a means to provide the re-
search in the area of human exposure methods development.
EPA Libraries: EJB HQ
37
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"Estimating Risk for Carcinogenic Environmental Contaminants and
Its Impact on Regulatory Decision Making
Cothern CR; Marcus WL
Regulatory Toxicology and Pharmacology. 4, 265-274, 1984
General overview of problems, complexities and uncertainties involved in regulatory
risk assessment.
"Estimation of the Risk to Human Health Due to Volatile Organic
Compounds in Drinking Water Using Trichloroethylene
Cothern CR; Coniglio WA; Marcus WL
Environmental Science and Technology 20. 111-115, 1986
Short, concise discussion of risk assessment methodology used in assessing quantitative
risk for carcinogens in drinking water using trichloroethylene as an example, 18 pages.
"Fuzzy Sets, Natural Language Computations, and Risk Analysis
Schmucker, Kurt J.
Rockville, MD, Computer Science Press, 1984
Keywords: Fuzzy Sets; Risk; Language and Languages
EPA Libraries: EKD Athens
Call Number: QA248.S345
""Indicators of Environmental Quality
Thomas, William A., Oak Ridge National Laboratory
New York, Plenum [1986]
286p, illustrated, Proceedings
0-306-36301-1 (hard cover)
0-306-20011-2 (paperback)
Type Document: Series: Environmental Science Research. Volume 1
Keywords: Risk Analysis Design and Testing;
Environmental Quality Indicators
Stressing the importance of developing a common denominator with which to assess the
environment, this systematic work examines indicators and indices which measure
variables and provide overall composite values for environmental shifts. By facilitat-
ing communication among diverse disciplines, this convenient shorthand system is es-
sential for solving these complex problems.
**Life Table Methodology for Evaluating Radiation Risk: An
Application based on Occupational Exposures
Bunger BM; Cook JR; Barrick MK
Environmental Protection Agency, Washington, DC,
Office of Radiation Programs
Health Phvs. (UK) v. 40:4. Apr 1981, 439-45p.
Type document: Journal article; numerical data
38
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This study describes an application of the life table method for examining the risk of
death from exposure to low-level ionizing radiation. The method provides estimates of
the expectation of premature death and the resultant life shortening. Applications to
occupational exposure situations are used to demonstrate the technique. Doses ranging
from 0.2 to 5.0 rem/yr and over age spans from 10 yr to working lifetimes are
investigated. A technique for comparing radiation related mortality with nonradiation
related risk of death from on-the-job accidents is introduced. Results show that
workers receiving whole body doses equal 5 rem/yr for sustained periods of time incur
significant risk of premature death from radiation induced cancer. The risk is
estimated, in some cases, to be as high as, or higher than, the average risk of accidental
death in high risk industries, depending upon factors such as length of exposure, age at
time of exposure, and the radiation risk model used. (DOE)
"Low-Probability/High-Consequence Risk Analysis. Issues, Methods and
Case Studies. Proceedings of the Society for Risk Analysis. Volume 2
Waller, Ray A., Los Alamos National Laboratory;
Covello, Vincent T., National Science Foundation; (eds)
Society for Risk Analysis
New York, Plenum [1986]
582p., Illustrated
0-306-41725-1
Type Document: Series: Society for Risk Analysis. Vol.2
Keywords: Risk Analysis, Low-Probability/High Consequence;
Estimation Methodology, Public Policy; Comparison of Methods
How effective are the methods currently used to estimate risks surrounding nuclear
and chemical accidents? How are estimates incorporated into public policies? What
are the criteria for comparing and evaluating different LP/HC risk analysis methods
and risk management policies? These are some of the questions tackled by a team of
specialists in fields ranging from toxicology to policy analysis.
Source of Abstract: Publisher
Mathematical Modeling Application to Environmental Risk Assessments
(Fate of Chemicals in the Environment)
Honeycutt RC; Ballantine LG
CIBA-GEIGY Corp, NC
ACS Sym Series 225, 1983, p249(14) Assn Report
An insect growth inhibitor is used as an example to show how a risk assessment can be
performed using the SWRB runoff model coupled to the exams chemical fate model.
Runoff of the compound from agricultural watersheds was estimated using the SWRB
model. These data were then used to estimate inhibitor loading into the exams model
for the aquatic environments. Maximum concentrations of the chemical that would oc-
cur in various compartments of defined ponds and lakes were computed. Expected
concentrations in water were then compared with acute and chronic toxicity data for
fish and aquatic invertebrates to establish a safety factor for the inhibitor in aquatic
ecosystems. (1 diagram, 3 references, 9 tables) (ENVL)
39
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"Measurement of Risks
Berg, George G.: Maillie, H. David,
The Univ. of Rochester School of Medicine and Dentistry, (eds.)
New York, Plenum, 1986
560p, illustrated, proceedings 0-306-40818-X
Type Document: Series: Environmental Science Research, Volume 21
Keywords: Risk Assessment Methodologies; Statistics; Comparative
Study; Cancer; Energy Sources; Inhalation Toxicology; Drinking Water
In this volume experts consider the problem of risk assessment from the philosophical,
statistical, and comparative viewpoints. Methods of risk assessment are examined, as
are topics ranging from the statistical inference of risks to such areas as cancer risks,
the comparative risks of energy sources, and the hazards of inhaled contaminants and
contaminated drinking water.
**A Methodology for Allocating Reliability and Risk
Cho, NZ; Papazoglou, IA; Bari, RA
Corporate Source: Brookhaven National Lab.;
Prepared for the U.S. Nuclear Regulatory Commission, Washington,
DC, U.S. Regulatory Commission, 1986
Report No.: NUREG/CR4048; BNL NUREG-51834
Type Document: Report
Keywords: Nuclear Power Plants; Decision Analysis;
Multiobjective Optimization; Risk Model; Preference Assessment;
Uncertainty Analysis; Reliability Cost Functions
EPA Libraries: EJB HQ
Call Number: TK9152-C54 1986
"Methods for Risk Assessment.
Symposium sponsored by American Chemical Society,
Division of Chemical Health and Safety (Probationary),
173rd ACS National Meeting, New Orleans, LA March 21-22, 1977
American Chemical Society
Keywords: Risk; Poisons; Safety Measures
EPA Libraries: EJE OTS
Call Number: HB615.R5
Methods in Risk Management - A Working Paper
Uppuluri, VRR, Oak Ridge National Lab., TN
Department of Energy, Washington, DC
NTIS/DE85008360
The methods in Risk Analysis to determine the health and environmental effects of
hazards to individuals and society are evolving in this rapidly developing field. In this
paper, we briefly discuss the current distinctions between Risk Assessment and Risk
Management, and discuss some methodological issues. We conclude this paper with a
method useful for prioritization in connection with the environmental, health, and
safety deficiencies at a number of sites. (9 references) (ERA citation 10:022730)
US/Japan workshop on tritium radiobiology and health physics, Tokyo, Japan, 29 Oct
1984. (NLM)
40
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"Multiple Factor Interaction in Environmental Disease: Potential
for Risk Modification and Risk Reversal
Selikoff, Irving J.
CUNY
Royal Society of Canada/et al Risk Assessment & Perception Sym,
Toronto, Oct 18-19, 82, p71 (9)
Conference paper: Risk assessment in environmental and occupational disease at
present has inevitable constraints. Emphasis has been on statistical analyses to establish
confidence limits. The limitations of this perspective exclude the rapid biological in-
novations that are accumulating, which can alter risk. Among these are multiple factor
interactions among agents. Using such information can not only modify risk but can
actually lead to risk reversal. (23 references, 4 tables) (ENVL)
New Mechanistic Models for Risk Assessment
Chandler, Jerry L.R., U.S. Food and Drug Administration
Fundamental and Applied Toxicology. 1985, Vo. 5, 634-652.
**
Perceiving Environmental Quality. Research and Applications
Craik, Kenneth H., Univ. of California at Berkely;
Zube, Ervin H., Univ. of Massachusetts (eds.)
New York, Plenum (1986)
324p, Illustrated
0-306-36309-7
Type document: Series. Environmental Science Research, Volume 9
Keywords: Risk Assessment Methodologies
Contributors from several fields discuss research needs and methodological issues in as-
sessing various environments --residential and institutional, scenic and recreational,
air, water and sound. Research strategies are suggested....This book should remain a
useful reference for several years.
Source of abstract: Perceptual and Motor Skills
"Rating the Risks
Slovic, Paul; Fischhoff, Baruch; Lichtenstein, Sarah
Perceptronics, ORE
Environment. Apr 79, V21, N3, P14 (12)
Technical feature: In order to improve hazard management, a risk assessment industry
has developed in the last 10 yr that combines the efforts of physical, biological, and
social scientists in identifying hazards and measuring the frequency and magnitude of
their consequences. Some risk assessments rely on extensive statistical data (e.g., the
frequency and severity of automobile accidents) and a degree of human judgment.
Others, such as those assessing the risks of nuclear power, must be based on theoretical
analyses or "fault trees." Four ways in which experts can misjudge potential hazards
are described. Methods for analyzing risk judgments are discussed. The roles of the
public and of experts in forming realistic risk assessments are considered. (3 diagrams,
1 drawing, 6 graphs, 9 photos, 24 references, 4 tables) (ENVL)
41
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A Review of Risk Assessment Methodologies
Report, March 1983
Marcus Gail H.
United States House Com. on Science and Tech.
Subcom. on Science, Research, and Tech.
'83 viii+78p, il tables charts
Series: 98th Cong., 1st sess.; Serial B; Com. print;
Order Info: Washington, DC 20515
Prepared by the Congressional Research Service, Library of Congress
Techniques used in the analysis of technology-based health and safety risks to human
beings. (PAIS)
"Risk Assessment for the Regulation of Carcinogens in the Environment
Cothern CR; Van Ryzin J; Saxena J (ed.)
In: Hazard Assessment of Chemicals, Vol. 4, pgs 179-241 1985.
New York, Academic Press, 1985
Risk analysis methodology, discussion of models used, uncertainty involved and ap-
plication to vinyl chloride and dichloromethane as examples.
**Risk Assessment of Complex Mixtures
Gibbs, HF; Chen CW; Waters MD; Sandhu SS
U.S. Environmental Protection Agency, Washington, DC 1985.
353-362 p.
EPA symposium on short-term genetic bioassays in the evaluation
of complex environmental mixtures, Chapel Hill, NC 27 Mar. 1984
New York, NY Plenum Press
Report No.: CONF-8403131-
Type document: Analytic of a Book; Conference literature While the simple model
presented here cannot explain all of the synergistic or antagonistic carcinogenic effects
observed in animal and human studies, the model can explain some of the data, and the
authors state that implications from the multistage mathematical model should be con-
sidered in the design of future animal studies or even of short-term bioassy studies. In
regard to animals, they suggest that mixtures be fractionated and administered in vary-
ing dosages at varying ages. They add that epidemiologic data should be reported
whenever possible to facilitate analysis of the affected carcinogenic state or stages on
which the complex mixture may be acting. They say, finally, that since an early-stage
carcinogen's effects may take many years for detection, this may in turn affect the
way in which we regulate complex mixtures and the way in which we study them.
(DOE)
42
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•Risk Assessment, Safety Evaluation of Food Chemicals
Newborne, Paul Medford
National Research Council (U.S.), Subcommittee on Food Toxicology
Washington, D.C., National Academy Press, 1980
Type Document: Book
Keywords: Food Analysis; Food Additives
EPA Libraries: EJE OTS; ELA R5
Call Number TK545.N3 1980
"Role of Mathematical Models in Assessment of Risk and in Attempts
to Define Management Strategy
Flamm, WG; Winbush, JS
Bureau of Foods, Food and Drug Administration, Washington, D.C.
Fundam ADD! Toxicol: Vol 4, ISS 3 Pt 2, 1984, PS395-401
Risk assessment of food-borne carcinogens is becoming a common practice at FDA.
Actual risk is not being estimated, only the upper limit of risk. The risk assessment
process involves a large number of steps and assumptions, many of which affect the
numerical value estimated. The mathematical model which is to be applied is only one
of the factors which affect these numerical values. To fulfill the policy objective of
using the "worst plausible case" in estimating the upper limit of risk, recognition needs
to be given to a proper balancing of assumptions and decisions. Interaction between
risk assessors and risk managers should avoid making or giving the appearance of
making specific technical decisions such as the choice of the mathematical model. The
importance of this emerging field is too great to jeopardize it by inappropriately
mixing scientific judgments with policy judgments. The risk manager should under-
stand fully the points and range of uncertainty involved in arriving at the estimates of
risk which must necessarily affect the choice of the policy or regulatory options
available. (NLM)
The Role of Multimedia Fate Models in Chemical Risk Assessment
(Fate of Chemicals in the Environment)
Eschenroeder, Alan
Arthur D. Little, Inc., MA
ACS Sym Series 225, 1983, p89(16) Assn Report
Mathematical models for chemicals moving through air, water, soil, and biota are re-
lated to methodologies for assessing health risks to individuals or ecosystems experienc-
ing environmental exposures. Procedures for assessing risks are traced from source to
receptors, and the application of models to this process is described. Acute risks are
distinguished from chronic risks in the context of environmental regulatory
requirements. A technique for selecting and assembling multimedia models based on
release, environmental, and receptor characteristics is explained. (22 references)
(ENVL)
43
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Study of Application and Suitability of Hazard/Risk Analysis Methodology
for Environmental Considerations
Kardos, G.
Carleton Univ, Ottawa
ENV Canada Report, Dec 80 (49)
Special report: The principal .methods presently used in Canada for risk/hazard
analysis are outlined. The usefulness and effectiveness of the techniques in contribut-
ing to the reduction of critical accidents are surveyed. Methodologies evaluated in-
clude failure mode and effect analysis, fault tree analysis, event tree analysis,
risk/benefit analysis, and safety analysis. These methods are found to be imperfect
instruments, depending heavily on the skill of the analyst. To be most effective,
risk/hazard analysis should be carried out concurrently and as part of, the design, by
the agency responsible. (13 diagrams, 1 graph, 27 references) (ENVL)
"Techniques for the Assessment of Carcinogenic Risk Due
to Drinking Water Contaminants. 1986
To be published in CRC Critical Reviews.
Risk analysis methodology and discussion of uncertainty for examples including
volatile organic compounds, inorganic compounds, pesticides, radionuclides,
microbiological contaminants, asbestos and others. 112 pages
"Techniques for the Assessment of the Carcinogenic Risk to the U.S. Population
Due to Exposure from Selected Volatile Organic Compounds from Drinking
Water via the Ingestion, Inhalation and Dermal Routes
Cothern CR; Coniglio WA; Marcus WL
Environmental Protection Agency, Washington, DC.
Office of Drinking Water, 1 May 84 254p
PB84-213941
A methodology is developed for the assessment of the risk due tu drinking water con-
taining trace levels of nine selected volatile organic compounds (VOCs). The nine
VOCs are; benzene, carbon tetrachloride, 1,1-dichloroethylene, 1,2-dichloroethane,
dichloromethane, perchloroethylene, 1,1,1-trichloroethane, and vinyl chloride. The risk
assessment contains two major parts; viz, a hazard assessment and an exposure
assessment. The hazard assessment uses animal bioassay data and extrapolates the
dose-response curve using four models; logit, probit, multistage and Weibull. The
hazard and exposure assessments are combined to estimate the population risk and
provide a risk reduction analysis. This latter analysis estimates the cases averted for
different control levels. An extensive analysis is included of the uncertainties to all
parts of the risk assessment. It is concluded that the uncertainty in exposure assess-
ment is less that an order of magnitude and that the uncertainty in hazard assessment
is 4-6 orders of magnitude. The largest contribution, by far, to the uncertainty in the
risk assessment is due to the choice of model to fit the bioassay data. (NTIS)
44
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**Toxicity Testing: New Approaches and Applications in Human
Risk Assessment [1985]
Li, AP
New York, Raven Press, 1985
Type Document: Conference Proceedings
Keywords: Toxicity Testing; Health Risk Assessment; Bibliography
Based on a conference held Sept 14-15, 1983 in the World Headquarters
of Monsanto Co, St. Louis, MO
EPA Libraries: EHA Rl; EKB RTP; ELB Cinn
Call Number: RA1199.T673 1985
"Uncertainty in Population Risk Estimates for Environmental Contaminants.
Cothern, CR; Coniglio WA; Marcus WL
U.S. Environmental Protection Agency, Office of Drinking
Water (WH-550), Washington, DC
To be published in the proceedings of the Annual Meeting
of the Society for Risk Analysis, Knoxville, TN,
October 1984, Plenum Press
Analysis of the uncertainties involved in estimating the risk to humans due to selected
volatile organic compounds in drinking water. 33 pages
Use of Environmental Health-Risk Analysis for Managing Toxic Substances
McKone, TE
Lawrence Livermore National Lab., CA
Sponsor: Department of Energy, Washington, DC
Report No.: UCRL-92329; CONF-850612-1, Mar 85 17p
Air Pollution Control Association annual meeting and exhibition,
Detroit, MI, 16 Jun 1985
Type Document: Conference Proceeding
Contract No.: W-7405-ENG-48
DE85008964/XAB
This paper presents a set of simple models used to assess health risks based on toxicity,
environmental mobility, and persistence. These models use a representative landscape
in order to describe the steady-state distribution of arsenic, tritiated water, and TCDD
as a result of continuous additions to soil. This information is used to assess potential
exposures. Application of the screening model to three chemically different car-
cinogens reveals that the environmental health risk does not scale with direct measures
of toxicity. As estimated here, the environmental health risk of TCDD relative to
tritiated water and arsenic is roughly an order of magnitude less than its cancer
potency relative to these compounds. The difference is attributable in large part to the
immobility of TCDD relative to tritium and the lower persistence of TCDD compared
to arsenic. The purpose is to present a simple procedure for using the relative behavior
of toxic species under prototype conditions as a basis for risk management. (21
references, 4 tables) ERA citation 10:026203. (NTIS)
45
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HEALTH RISKS
GENERAL
"Advances in Health Risk Assessment for Systemic Toxicants and Chemical Mixtures
An International Symposium [1985]
Stara Jerry F; Erdreich Linda S
Princeton, NJ, Princeton Scientific, 1985
Type Document: Series: Toxicology and Industrial Health
0748-2337 V. 1, No. 4
Keywords: Environmental Health; Health Planning; Decision-Making;
Health Risk Assessment; Toxicity Testing
EPA Libraries: ELB Cine.
Call Number: RA 565.A2A38 1985
"Application of Risk Assessment to Food Safety Decision Making
Rodricks J, Taylor, MR
Environ Corporation, Washington, DC
Reeul Toxicol Pharmacol. 3(3):275-307 1983
The purpose of this report is to present the scientific basis of risk assessment and to
demonstrate that risk assessment can be used to make decisions about the safety of our
food supply. The report has been prepared as a resource for those involved in the cur-
rent discussions in Congress and elsewhere over the policies by which the safety of the
American food supply is evaluated and assured. The document is not intended to
present an argument for any particular food safety policy, but rather to address a key
scientific issue that arises in the review of policy options. It distinguishes risk
assessment—the acientific process of identifying and evaluating potential risks—from
risk management, the separate policy decision regarding what constitutes "safety" or an
acceptable degree of risk. (NLM)
"Assessment of Risk from Low-level Exposure to Radiation and Chemicals:
A Critical Overview [1985]
Woodhead, Avril D.
Brookhaven National Laboratory
New York, Plenum, 1985
Type Document: Series: Basic Life Sciences, V. 33
Keywords: Ionizing Radiation; Toxicology; Health Risk Assessment
Papers presented at Brookhaven National Laboratory,
Upton, NY, May 20-23, 1984
EPA Libraries: EJA R3; ELB Cinn.
Call Number: RA1231.R2A78 1985
47
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"The Characteristics of an Adverse Effect: Using the Example of Developing
a Standard for Lead
Presented at a symposium entitled "Scientific Praxis in Risk Management"
at the annual meeting of the American Association for the Advancement of Science,
Los Angles, CA, May 29, 1985
Marcus, WL, Cothern, CR
Drue Metabolism Reviews. 16(4):423-440, 1985
Examination of the different health related endpoints due to exposure to environmen-
tal lead and discussion of which to choose in the development of a standard.
"Chemical Emergency Preparedness Program: Chemical Profiles
Interim Guidance
Environmental Protection Agency, Washington, DC
Dec 85, 1435p EPA/560/7-85/013
NTIS NO. PB
PB86-155264/REB
See also PB86-155256/REB
Keywords: *Chemical Compounds, *Toxicity, *Air Pollution, *Management
Planning, *Hazardous Materials, Sites, State Government,
Accidents, Tables(Data), Safety, Chemical Properties, Physical
Properties, Chemical Analysis, Fire Safety, *National Air Toxics
Strategy, *Toxic Substances, Environmental Protection Agency,
Listings, Occupational Safety and Health.
The document, developed by the U.S. Environmental Protection Agency (USEPA), is
part of the USEPA National Air Toxics Strategy. The document is provided in support
of EPA Chemical Emergency Preparedness Program (CEPP) which deals with acciden-
tal release of acutely toxic chemicals. For each acutely toxic chemical listed in the
CEPP guidance document (report number PB86-155256), a chemical profile is available.
A chemical profile is a collection of information on the chemical identify hazardous
identity, physical/chemical characteristics, fire and explosive hazard, reactivity,health
hazard, use, and precautions for handling and use of the chemical. The information is
presented in the format that conforms as closely as possible to the Occupational Safety
and Health Admininstration (OSHA) recommended format for a Material Safety Data
Sheet (MSDS).
"Critical Considerations in the Assessment of Health and Environmental
Risks — What We Have Learned from the Nuclear Experience
Vaughan, Burton E.
The Science of the Total Environment. 1983 Vol. 28 (June), p. 505
(ENV Bib)
48
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"Evaluation and Risk Assessment of Chemicals:
Proceedings of a Seminar, Lodz, Poland, 1-6 September 1980
Copenhagen, World Health Organization, 1982
Type Document: Series: Health aspects of chemical safety.
Interim Document No. 6
Keywords: Chemicals; Safety Measures; Toxicity Testing
EPA Libraries: EJB HQ TP149.W66 No.6; EKA R4 TP149.$b.W66
No.6; EKC G.Breeze; EMB ADA; ESB Corvallis TP149.E8
"Food Safety: Revising the Statute
Kessler, DA
Montefiore Medical Center, Bronx, NY
Science. 223(4640:1034-40 1984
There is increasing recognition that federal food safety laws and policies need to be
revised. Congressional debate on proposed amendments to the Food, Drug, and Cos-
metic Act has generated several different perspectives on how the food safety laws
should be changed. Before a consensus can be reached, scientists, regulators, the food
industry, and consumers will have to review such complex and controversial issues as
the level of acceptable risk, the value of risk-benefit analysis, the proper role of inde-
pendent scientific review, and the reliability of quantitative risk assessment. (NLM)
**A Framework for Assessing Health Risks Associated with National Ambient
Air Quality Standards
Richmond, Harvey M.
EPA Office of Air Quality Planning and Standards
The Environmental Professional 1981, Vol. 3, p.225-233
EPA Libraries: EJB HQ
"Health and Environmental Risk Assessment
Ricci, Paolof; Rowe, MD
Corporate Source: Electric Power Research Institute,
Brookhaven National Laboratory
New York, Pergamon Press, 1985
Type Document: Conference Proceedings
Keywords: Energy Development; Energy Industries; Health
Risk Assessment
Based on a workshop held at Brookhaven National Laboratory,
Dec. 1981
EPA Libraries: EKB RTF
Call Number: RA568.5H4
49
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Improving the Characterization and Treatment of Uncertainty in Health
and Environmental Risk Assessments
Final Report
Morgan MG, Henrion M
Carnegie-Mellon Univ, Pittsburgh, PA, Dept. of Engineering
and Public Policy
Department of Energy, Washington, DC
NTIS/DE86005743, 14p
TD3: Uncertainty plays a centrally important role in health and environmental risk
assessment. However, in the majority of quantitative health and environmental risk
assessments the characterization and treatment of this uncertainty has been quite
inadequate. We have worked on several aspects of the problem of improving such
treatment. First, we have made a variety of improvements in the C-MU developed
Demos computer based modeling environment, and have also prepared a Demos user
tutorial to assist new users who want to use this software environment for the treat-
ment of uncertainty in their risk analyses. Second, we conducted a research workshop
on the problems of classifying sources of uncertainty and the problems of propagating
uncertainty through models. This report includes a working paper on these subjects.
Third, in a cooperative effort that has also involved NSF and other support, we have
been engaged in the preparation of a monograph titled Uncertainty: A guide to the
characterization and treatment of uncertainty in risk and other quantitative policy
analysis. A detailed outline of this monograph is presented in this report. (ERA cita-
tion 11:014740) (NLM)
'Principles of Health Risk Assessment
Ricci, Paolo, F.
Englewood Cliffs, NJ, Prentice-Hall, 1985
Keywords: Environmental Health—Evaluation; Risk
EPA Libraries: ELB Cinn
Call Number: RA566.P74
"Risk Assessment Review Group Report to the U.S. Nuclear Regulatory Commission
Lewis, Harold Walter
Corporate Sources: U.S. Nuclear Regulatory Commission
Washington, DC, U.S. Nuclear Regulatory Commission, 1978
Type Document:.Report
Keywords: Health Effects; Nuclear Power Plants; Radiation Hazards
EPA Libraries: EKT RTP; EIA R2 Y3.N88:25 0400
**Toxicological Risk Assessment
Clayson, DB; Krewski, D; Munro, Ian C.
Boca Raton, FL, CRC Press, 1985
Type Document: Book
Keywords: Toxicity Testing; Health Risk Assessment;
Government Policy; Decision-Making; Environmental Health
EPA Libraries: EJA HQ; EJB HQ; EJE OTS; EKB RTP;
ELB Cinn; ELD Duluth
Call Number: RA1199.T68 1985
50
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HEALTH RISKS
CANCER .... includes carcinogenesis, carcinogens, carcinogenicity, genetics, epidemiology,
and multi-media exposure.
"Approach to Risk Assessment for Genotoxic Carcinogens Based on Data
from the Mouse Skin Initiation-Promotion Model
Burns F; Albert R; Altshuler B; Morris E
Institute of Environmental Medicine, New York University
Medical Center, NY
Environ Health Persoect. Vol 50, 1983, p309-20
(NLM)
Basic Requirements for Health Risk Analysis: The Decision Point
Approach for Systematic Carcinogen Testing
Weisburger JH; Williams GM
Naylor Dana Inst. Dis. Prevent., American Health Found., Valhalla
Health Risk Anal., Proc. Life Sci. Symp., 3rd; 1981, 249-71
CBAC COPYRIGHT: CHEM ABS. A review with refs.
Review genotoxicity carcinogen detection.
(NLM)
Cancer and the Environment: Possible Mechanisms of Thresholds for
Carcinogens and Other Toxic Substances
New York, Mary Ann Liebert, Inc., 326 p., 1983
Papers on possible mechanisms of thresholds for carcinogens and other toxic substances
reported at the Symposium of the International Study Center for Environmental Health
Sciences, held in New York City, November 2-4, 1981, are presented under the follow-
ing titles: potential role of intercellular communication in the rate-limiting step in
carcinogenesis; chemical, physical, and genetic factors interfering with DNA repair - a
review; the importance of pharmacokinetic principles in characterizing carcinogenic
thresholds for naturally occurring and synthetic chemicals; metabolic activation of
xenobiotics: ethylene dibromide and structural analogs; thresholds in chemical
carcinogens; catabolic function of peroxisomes: modification by hypolipidemic drugs;
systems detoxifying chemical carcinogens; importance of threshold in safety assessment
of food additives, significance of animal pathology observations; artifacts due to
secondary pathology: case study examples; chasing a receding zero: impact of the zero
threshold concept on actions of regulatory officials; chemical basis for cell mutation;
the development of secondary pathology with free radical reactions as a threshold
mechanism; dose patterns of cellular effects induced by carcinogens: evidence for the
presence or absence of thresholds; effect of antioxidants on free radical production
during in vivo metabolism of carbon tetrachloride; thresholds in carcinogenesis - a
view from epidemiology; cancer hazards, risk and thresholds: an assessment; species
longevity as an indicator for extrapolation of toxicity data among species of placental
animals; thresholds in acute and long term animal studies; stages in cancer
51
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development; opportunities for thresholds; possibilities for dietary fat and an
tioxidants as modulators of mammary carcinogens; dietary and other modulators of
carcinogenesis; and implications for the future: regulation of chemicals and prevention
of cancer. (NLM)
The Cancer Problem: Risk Assessment
Ecolibrium. Fall 78, V7, N4, P4 (4)
Technical Feature: While many scientists agree that most cancer cases are caused by
factors external to the human body, regulatory agency reactions that ban any contact
with suspected environmental carcinogens may be extreme. There are "no-effect" ex-
posure levels to most substances, and some may even be essential in small amounts. A
knowledge of the risks is necessary before regulations are imposed on the public. Much
regulation is currently based on studies with mice; scientists and statisticians are find-
ing that variations in such environmental test conditions as diet, dust, noise, and stress
may cause background noise in test results, making conclusions drawn from such
studies tenuous. Other accepted bioassay techniques should supplement mouse studies
to establish the carcinogenic risk of various substances. (ENVL)
Carcinogenic Potency and Risk Assessment
Squire RA
Division of Comparative Medicine, Johns Hopkins
University School of Medicine, Baltimore, Maryland
Food Addit Contam. Vol 1, ISS2, 1984, p221-31
An overview of carcinogenesis risk assessment is presented. The nature of evidence for
carcinogenic potential in humans is discussed, including possible carcinogenic
mechanisms, genotoxicity and laboratory animal data. Emphasis is given to the impor-
tance of including all pertinent evidence in risk assessment, rather than placing total
reliance on mathematical extrapolations from animal tumour data. An approach to
ranking animal carcinogens according to the weight of evidence is described briefly.
(NLM)
Carcinogenic Risk Assessment: A Toxicologist's View
Purchase IF
Imperial Chemical Industries PLC, Alderley Park, Macclesfield,
Cheshire, England
Banbury Rep; 19:175-85 1985
Risk quantitation is but one step in the overall process of risk management that is
aimed at protecting the health of those exposed to chemicals. The drive for better
quantitative methods of assessing carcinogenic risk has led to the development of a
number of mathematical models for extrapolating data derived from animal
experiments, usually conducted at high doses, to the risk that is likely to occur with
substantially lower exposure levels. Two examples are used to illustrate the way in
which simple mathematical extrapolation provides estimates of risk at low dose which
are clearly incompatible with the existing knowledge of mechanisms of action or
knowledge of epidemiology. In the case of vinyl chloride, mathematical models are
52
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used to extrapolate from each of the animal studies a dose that is likely to produce a
risk of one in 10(-6). The range of doses produced was so wide that the utility of the
procedure is called into question. In a second example, trichlorethylene carcinogenesis
is used to illustrate an instance in which information on the mechanism of car-
cinogenic action can provide evidence that mathematical extrapolation methods are
unsuitable. The evidence of lack of susceptibility of human tissues in vitro, together
with knowledge of the nongenetic mechanisms of carcinogenesis for this compound,
indicate that the mouse data are unsuitable for risk assessment in man. Risk assess-
ment procedures are discussed under the following headings: hazard identification;
hazard assessment; and risk assessment. The single most important attribute of the risk
assessment process is that it should provide an accurate assessment of risk. Risk
assessment should also share other characteristics of scientific activities, including
reproducibility and compatibility with other knowledge. The ability to test the as-
sumptions on which the assessment process is based is also an important attribute. Cur-
rently available methods of risk assessment do not have all of these attributes. (23
references) (NLM)
Clues to Cancer Etiology from Time-Related Epidemiologic Observations
Fraumeni J Jr; Blot W
Div. of Cancer Etiology, NCI, Bethesda, MD
Time Related Factors in Cancer Epidemiology.
May 15-17, 1985, Bethesda, Maryland, 1985
Observations of time-related variation in cancer occurrence and in environmental ex-
posures or host factors can often provide insight toward the identification of etiologic
agents and assessment of their mechanisms of action. This review provides examples
of such observations from recent and ongoing epidemiologic investigations, classifying
the studies as descriptive, case-control, cohort, or experimental and noting limitations
and advantages of these types of investigations. The examples include: (1) Descriptive
analyses of the changing temporal patterns of age-specific breast cancer mortality rates
and their relation to temporal variations in childbearing practices and in treatment
modalities that affect survival rates at young ages; (2) Case-control analyses of lung
cancer and mesothelioma, in which a narrow window of observation limited assessment
of latency of shipyard-related malignancy, but did not suggest that the timing was as
important as the duration of exposure for lung tumors identified during the fixed as-
certainment period, and in which the effects of intensity and age at exposure differed
considerably between lung cancer and mesothelioma; (3) Cohort analyses of arsenic-
exposed smelter workers, where risk of cancer varied with age started working, age
stopped, and calendar time; and (4) Issues in the design and analysis of an intervention
trial in an area of China at exceptionally high risk of esophageal cancer, where com-
binations of nutrients are being evaluated as inhibitors of late-stage events. (NLM)
Definition of a Carcinogen as a Potential Human Carcinogenic Risk
Weisburger JH
Naylor Dana Inst. Dis. Prevent., Amer. Health Found., Valhalla
Jon. J. Cancer Res. (GANN); Vol ;76, ISS 12, 1985; 1244-6
CBAC COPYRIGHT: CHEM ABS. The data base required for risk assessment and the
protection of man against cancer hazards from suspect chems. involves systematic ac-
quisition of data and anal, of the following: (1) structure-activity relations, (2) results
53
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from a battery of short-term in vitro tests yielding data that indicate genotoxicity, and
(3) in vivo bioassays indicating a high incidence of malignant neoplasms in mice, rats,
and (or) hamsters with a relatively short latent period. Human cancer risks are thereby
defined by studies that yield clear pos. results. (NLM)
**The Distinct Heal'th Risk Analyses Required for Genotoxic Carcinogens
and Promoting Agents
Weisburger JH; Williams GM
Naylor Dana Institute for Disease Prevention, American
Health Foundation, Valhalla, NY
Environ Health Perspect: Vol 50, 1983, p233-45
Estimating the Risks of Cancer Mortality and Genetic Defects Resulting
from Exposures to Low Levels of Ionizing Radiation
Buhl TE; Hansen W
Los Alamos National Lab., NM
NTIS/DE84013855, pi 17 1984
Estimators for calculating the risk of cancer and genetic disorders induced by exposure
to ionizing radiation have been recommended by the US National Academy of Sciences
Committee on the Biological Effects of Ionizing Radiations, the UN Scientific Com-
mittee on the Effects of Atomic Radiation, and the International Committee on
Radiological Protection. These groups have also considered the risks of somatic effects
other than cancer. The US National Council on Radiation Protection and Measure-
ments has discussed risk estimate procedures for radiation-induced health effects. The
recommendations of these national and international advisory committees are sum-
marized and compared in this report. Based on this review, two procedures for risk es-
timation are presented for use in radiological assessments performed by the US
Department of Energy under the National Environmental Policy Act of 1969 (NEPA).
In the first procedure, age- and sexaveraged risk estimators calculated with US average
demographic statistics would be used with estimates of radiation dose to calculate the
projected risk of cancer and genetic disorders that would result from the operation
being reviewed under NEPA. If more site-specific risk estimators are needed, and the
demographic information is available, a second procedure is described that would in-
volve direct calculation of the risk estimators using recommended risk-rate factors.
The computer program REPCAL has been written to perform this calculation and is
described in this report. (Author abstract) (25 Refs) (NLM)
Familial Cancer: Genetically Determined?
(Review)
Weber W; Ott J; Gencik A; Muller H;
Laboratory of Human Genetics, Cantonal Hospital, Basel, Switzerland
Anticancer Res. 3(2): 133-42 1983
Many cancers, in both children and adults, cluster in? families. Collection and statis-
tical analysis of pedigree data suggest that genetic mechanisms play an important role
in most cancer types. This is illustrated in colorectal, breast, lung, ovarian, and
54
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childhood cancer. Pedigree data are consistent with the hypothesis that cancer is some-
times inherited in an autosomal dominant Mendelian fashion. These rare hereditary
cancers might not be different pathogenetically from those arising sporadically. A
two-stage model for carcinogenesis provides a framework for the understanding of
both forms of cancer. The establishment of registries for familial cancer would be
most helpful for cancer risk determinations, surveillance and management programs,
identification of new cancer-prone genotypes and etiological family studies. (NLM)
From Biochemical Epidemiology to Cancer Risk Assessment
[Draft, 1986]
Alavanja, M; Aron, J; Brown, C, National Cancer Institute;
handler, J, U.S. Food and Drug Administration
Hazardous Substances and Cancer Incidence: Introduction to the Special
Issue on Risk Assessment and Risk Management
Wolf, Katy, Rand Corp. CA
J. Hazardous Materials. Jul 85, V10, N2-3
Journal article: Currently known causes of cancer are identified from epidemiological
and animal studies. Epidemiology has its main use in verifying that substances are
carcinogens; its utility does not lie in prevention. Possible relationships between the
production and use of synthetic substances and cancer are explored, and risk assess-
ment and management technologies are summarized. (ENVL)
High to Low Dose Extrapolation of Experimental Animal Carcinogenesis Studies
Brown CC
National Cancer Inst., Bethesda, MD
Available from National Technical Information Service,
Springfield, VA as NTIS/AD-P003 856/2, 26 p 1984
Quantitative risk assessment requires extrapolation from results of experimental assays
conducted at high dose levels to predicted effects at lower dose levels which cor-
respond to human exposures. The meaning of this high to low dose extrapolation
within an animal species will be discussed, along with its inherent limitations. A num-
ber of commonly used mathematical models of dose-response necessary for this
extrapolation, will be discussed. Other limitations in their ability to provide precise
quantitative low dose risk estimates will also be discussed. These include: the exist-
ence of thresholds; incorporation of background, or spontaneous responses; modifica-
tion of the dose-response by pharmacokinetic processes. This article is from Proceed-
ings of the Conference on the Design of Experiments in Army Research, Development
and Testing (29th) held at Bethesda, Maryland on 19-20 October 1983. (Author
abstract) (NLM)
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Interpretation and Extrapolation of Chemical and Biological Carcinogenicity
Data to Establish Human Safety Standards
Anderson RL; Arnold DL; Carlson RG; Chang C; Clarke MD;
Clayson DB; Dai Y; Emerson DV; Fishbein L; Garattini S
Proctor and Gamble Company, Cincinnati, OH
Current Issues in Toxicology. Grice HC, ed. New York, Springer-Verlag,
p. 1-152, 1984
EPA Libraries: EJE OTS; ELB Cinn
Call Number: RC268.65.158
The interpretation and extrapolation of animal data for predicting human health ef-
fects from carcinogens or chronic toxicants is a complex process involving many
uncertainties. Some of the factors involved in the process are outlined, taking into ac-
count the relevant chemical and biological properties of the compound of interest and
the strengths and limitations of the test systems employed. The principal source of
evidence for carcinogenic potential is the chronic toxicity/carcinogenicity bioassay in
rodents. A critical review of this procedure is presented, with emphasis on those fea-
tures that constitute an adequate study by current standards. The salient elements of
test design, conduct, and interpretation are outlined. Short-term tests which provide
corroborative information are described and their predictive value is discussed. The
manner in which the animal metabolizes a chemical can have a marked influence on
the toxicity of the chemical. Thus, interpreation of animal studies in the light of
pharmacokinetics and metabolism is considered. Synergistic and antagonistic effects
are considered as humans routinely come in contact with numerous natural and syn-
thetic chemicals, and may therefore be exposed to more than one potentially injurious
chemical at any given time. The present knowledge of carcinogenic mechanisms is
reviewed, and their implications in extrapolation to humans are considered. An at-
tempt is made to describe the various chemical and biological properties that may con-
tribute to assessment of carcinogenic risk of chemicals to humans. The establishment
of safe and realistic guidelines for human exposure to carcinogens is considered. (844
Refs) (NLM)
Mechanisms of Chemical Carcinogenesis: Recent Advances
Fournier PE; Thomas G
Cinique Toxicologique, Hospital Fernand Widal, Paris
Food Addit Contam. 1(2):73-80 1984
The carcinogenetic risk assessment of veterinary drugs has to be envisaged as part of
food toxicology. The authors review the recent discoveries which have proved sig-
nificant for the toxicologist. Tumours arise from an inherited transformation of nor-
mal cells through genotoxic, perigenetic and epigenetic processes. Genotoxic
mechanisms are best understood and have led to the development of short-term
reference tests. The biochemistry of DNA alterations is being unravelled and permits
quantitative estimation of carcinogenetic potencies. Work on the role of oncogenes is
providing new clues to the understanding the mechanisms of chemical carcinogenesis.
Perigenetic processes deal mainly with DNA repair systems and emphasize the com-
plexity of human genome dynamics. Experimental findings about epigenetic
mechanisms are still inconclusive as to their practical implications. Abnormal expres-
sion of HLA-antigens at the surface of neoplastic cells has been reported, but its sig-
nificance is still unknown. In conclusion, the main source of progress in toxicology
undoubtedly comes from molecular biology, but experimental results must be inter-
preted with caution if practical issues are to be derived from them. (53 Refs) (NLM)
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Mechanisms of Chemical Interaction in Carcinogenesis (Human, Mice)
Williams JR
Johns Hopkins Oncology Center, 600 North Wolfe St
Room 2-121, Baltimore MD
CRISP/86/ES03644-02
U.S. Dept of Health and Human Services; Public Health Service;
National Inst of Health, National Institute of Environmental
Health Sciences
CRISP Data Base National Institutes of Health
RPROG/CRISP Epidemiological studies on the etiologies of human cancers are exceed-
ingly difficult due to the multiplicity of carcinogens to which humans are exposed,
and due to the long latency periods between exposure and the expression of the disease
state. The multiplicity of exposures also complicates efforts to predict human cancer
risks based on bioassays in which animals are exposed to a single agent. In order to
make better predictions for human cancer risks, it is exceedingly important to under-
stand the mechanisms by which low levels of environmental carcinogenic agents inter-
act to promote this disease. We have selected a group of known or suspected car-
cinogenic agents and propose to measure patterns of interaction for endpoints which
are highly correlated with the carcinogenic pathway. Specific agents were chosen
based on i) our knowledge of the mechanism by which they produce DNA damage and
the type of lesions which result, and ii) either because some of these agents are cancer
chemotherapeutic drugs, permitting comparison with human responses, or because the
agents are ubiquitous in our environment, and exposures are unavoidable. We propose
to examine several endpoints in vitro which include: cytotoxicity, specific locus
mutation, sister chromatid exchange, chromosomal aberrations, and inhibition of cell
replication kinetics. These last three endpoints will also be studies in vivo and in utero
to confirm the validity of in vitro observations. The time interval between exposures
is an important parameter in evaluating potential interaction. Our protocols will
evaluate both simultaneous and sequential exposure to carcinogenic agents. Simul-
taneous exposure to interactive agents will determine if acute effects are mitigating,
additive or synergistic. Exposures separated by both long (hours) and short (days or
greater) intervals will measure how risk factors are affected by histories or previous
exposures. These types of data may prove important in predicing human risks involved
in exposure to multiple carcinogenic agents. (NLM)
"Mechanisms of DNA Damage and Repair. Implications for Carcinogenesis
and Risk Assessment
Proceedings of a Symposium, June 2-7, 1985, Gaithersburg, MD
Basic Life Sci: 38:1-578 1986
(NLM)
"Mechanisms of DNA Damage and Repair: Implications for Carcinogenesis
and Risk Assessment
Simic, Michael G., Upton, Arthur D. (eds.)
U.S. National Bureau of Standards
New York, Plenum Press, 1986
Type Document: Series: Basic Life Sciences, Volume 38
EPA Libraries: EJB HQ
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Multimedia Exposure and Concerns for a Holistic Approach Toward Assessment
of Risk for Environmental Carcinogens
Kraybill, Herman F.
Natl Cancer Inst, Div of Cancer Cause & Prevention, Bethesda, MD
Conference title: Exposure to Environmental Agents, their
Metabolism, and Mechanisms of Toxicity, Rockville, MD, January 1981
Sponsor: EPA, Task Force on Environmental Cancer & Heart Lung Disease
Source: Journal of'Environmental Science and Health, Part A,
Environmental Science and Engineering v A17 n 4 1982, p491-497 1982
Keywords: *Carcinogens; Man-environment interaction; Multiple
Exposures to Toxic Agents; Exposure-Response Relationships;
Risk Analysis; Pesticides; Chemicals Pollution; Health Risk
from Exposure to Toxic Agents; Epidemiologic Studies; Food and Diet;
Nutritional Surveys (El)
Non-Regulatory and Cost-Effectiveness Control of Carcinogenic Hazard.
The Beginnings: A Methodology for Using Animal Data to Decrease
Uncertainty in Human Risk
Crouch EAC; Feller J; Fiering MB; Hakanoglu E; Wilson R
Harvard Univ., Cambridge, MA. Energy and Environmental Policy Center
Sponsor: Department of Energy, Washington, DC
Report No.: DOE/EV/10598-1, Sep 82 12p
Contract No.: AC02-81EV10598
DE83009531
A logical cost effective procedure for assessing carcinogenic risk associated with
emerging energy technologies is outlined. All chemicals are assumed to be carcinogenic
with a potency that has to.be measured. In this scheme a non-carcinogen is a chemical
with zero potency. If the carcinogenic potency in animals has not been measured, it
may be assumed from an a priori measure. Using estimates of potency, exposure, and
an interspecies factor (which also accounts for uncertainties in extrapolating the
animal data to man), an estimate of risk and the uncertainty associated with that es-
timate is made, together with upper bounds on the risk. If the upper bound is small
the risk is negligible and can be ignored. If is is large, the exposure at the level
proposed should not be permitted. However, further information may be obtained
which changes the risk estimate or lowers the uncertainty so that the upper bound on
the risk is reduced. Notice that estimation of the uncertainty is as important as es-
timation of a best value of risk. (ERA citation 08:030532) (NTIS)
**Risk of Carcinogenesis from Long-Term Low-Dose Exposure to Pollution
Emitted by Fossil-Fueled Power Plants
Watson, Donald E.
Lawrence Radiation Lab. Biomedical Div. Livermore, CA.,
Univ. of California, 1970
EPA Libraries: EKB RTP
Call Number: AEC/UCRL-50937
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HEALTH RISKS
GENOTOXICITY AND REPRODUCTIVE EFFECTS .... includes development and
reproductive effects; embryo and fetal effects, fertility, exposure during pregnancy,
teratogenicity, mutagenesis and mutagenicity; genetics and carcinogenesis; and neoplasia.
Adverse Effects in Humans and Animals of prenatal exposure to Selected
Therapeutic Drugs and Estimation of Embryo-Fetal Sensitivity of Animals
for Human Risk Assessment
Khera KS
Health Protect. Branch, Sir Frederick Bant. Res. Cent., Ottawa
Issues Rev. Teratol: Vol 2, 1984:399-507
CBAC COPYRIGHT: CHEM ABS A review with apprx. 570 refs. of teratol. studies in
humans and exptl. animals with selected drugs of suspected or known human teratol.
potential. Attempts were made to define a predictable relation between the teratogenic
or embryotoxic doses in animals and the corresponding doses in humans. (NLM)
**Aneuploidy and Health Risk Assessment: Current Status and Future Directions
Dellarco VL; Mavournin KH; Tice RR
Environmental Protection Agency, Washington, DC
Environ. Mutaeen. v 7:3. 1985. 405-424 p. 424
Type document: Journal article; Numerical data
Subfile: ERA (Energy Research Abstracts)
Contract No. AC02-76CH00016
The US Environmental Protection Agency (EPA) recently sponsored a workshop to dis-
cuss (1) the contribution of aneuploidy to human disease and disability; (2) the
development of tests for detecting chemicals that induce aneuploidy and the relevance
of these tests to human risk, and (3) the current understanding of mechanisms by
which aneuploidy arises. This summary is based on the presentations given at the
workshop. It is hoped that this summary will stimulate thinking in this vitally impor-
tant area of risk assessment and contribute to the establishment of priorities for basic
research, development of new test methods, and validation of existing test approaches.
Such research is needed to enhance the scientific basis for risk assessment for
aneuploidy-producing chemicals. (DOE)
Application of Mutagenicity Tests in Assessing Occupational Cenotoxic Risks,
in: Mutagens in Our Environment
Vainio H; Sorsa M
Prog Clin Biol Res: 109:433-442, 1982
(NLM)
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Approach to Risk Assessment for Genotoxic Carcinogens Based on Data
from the Mouse Skin Initiation-Promotion Model
~ Burns F; Albert R; Altshuler B; Morris E
Institute of Environmental Medicine, New York University
Medical Center, NY
Environ Health Perspect: Vol 50, 1983, P309-20
(NLM)
"Assessment of Chemicals Affecting the Male Reproductive System
Dixon RL
Laboratory of Reproductive and Developmental Toxicology,
National Institute of Environmental Health Sciences, Research
Triangle Park, NC
Arch Toxicol FSupplI: Vol 7, 1984, pi 18-27
The reproductive toxicologist must be more concerned with the ability of laboratory
models to predict human reproductive hazards and to estimate human health risks. Al-
though more than a hundred chemicals have been reported to affect the reproductive
capacity of male laboratory animals, fewer than 15 environmental chemicals have been
shown conclusively to affect man and many of these are known mutagens, carcinogens
or otherwise generally toxic agents. Pharmacokinetic and adaptive factors must be
considered. More attention also needs to be directed towards processes other than
spermatogenesis and towards mechanisms of toxicity other than cytotoxicity. The male
component necessary for successful reproduction depends on a large variety of biologi-
cal processes working in concert. The ability to assess chemically-induced reproductive
effects needs to be refined and modern molecular and cellular approaches should be
developed and validated. This paper summarizes aspects of the pharmacokinetic and
adaptive factors involved in testicular toxicity, some current laboratory assessment
techniques, and newer test procedures such as monoclonal antibodies for sperm surface
proteins and the interspecies (human/hamster) sperm penetration assay. (NLM)
The Assessment of Embryotoxicity Risks in Man-Made Ecology A Permanent
Multidisciplinary Inquiry
Kucera J
Marois, M. (Ed.)
Progress in clinical and biological research, Vol. 163B.
Prevention of Physical and Mental Congenital Defects:
Part B: Epidemiology, Early Detection and Therapy,
and Environmental Factors; Proceedings of an International
Conference of the Institut de la Vie, Strasbourg, France,
Oct. 10-17, 1982. XXV:492P.
Alan R. Liss, Inc., New York, NY
Illus. ISBN 0-8451-0184-6; 0 (0). 1985. 69-74
BIOSIS COPYRIGHT: BIOL ABS.RRM Teratogen Congenital
Anomaly Frequency. (NLM)
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Assessment of Reproductive and Genetic Monitoring in Occupational
Settings: Government Viewpoint
Sakai C
U.S. Environmental Protection Agency, Washington, DC
Prog Clin Biol Res: Vol 160, 1984, p541-9
(Ref: 20) (NLM)
"Assessment of Reproductive and Teratogenic Hazards
Christian MS; Galbraith WM; Voytek P; Mehlman M
Princeton Scientific Publishers, Princeton, NJ
1983, I60p Illus Bibl. Index
EPA Libraries: EJE OTS; EKB RTP
Call Number: QP251.A86
Section I of this volume includes a statement of the problem, an overview of historical
perspectives and a discussion of major incidents that have raised concern about
reproductive hazards and deals with hazards presented by environmental substances,
Pharmaceuticals, radiation and food additives and with practical applications of sys-
tems for rapid detection of potential teratogenic hazards. Section II contains the
proceedings of two conferences sponsored by the US Environmental Protection Agency
(1-3 Oct. 1980, Atlanta, Georgia, 7-10 Dec. 1980, St. Louis, Missouri) and describes in
detail a variety of toxicity and screening tests available to assess risk to female
reproduction. Reproductive hazards to males are also examined, and the current state
of knowledge on estimation of risk to human conceptus from environmental substances
is presented. (NLM)
Assessment of Reproductive Risks
Clegg ED; Sakai CS; Voytek PE
Reproductive Effects Assessment Group,
U.S. Environmental Protection Agency, Washington, DC
Biol Reorod: Vol 34, ISS 1, 1986, p5-16
In the regulatory process, the hazards posed by potentially toxic agents to the female
and male reproductive systems and to developing young are evaluated by risk assess-
ment procedures. In this paper, toxicity testing and the regulatory process are
discussed, with emphasis on risk assessment. The suggested testing protocols of the Pes-
ticide Assessment Guidelines (U.S. EPA) are presented as an example of testing that
might be done to produce toxicity data for an agent. Protocols and endpoints that are
utilized in testing for reproductive effects are described. Included are acute,
subchronic, chronic, and short-term tests. The four components of reproductive risk
assessment (hazard identification, dose-response assessment, exposure assess-ment, and
risk characterization) are examined. Effects of dibromochloropropane on rabbit tes-
ticular parameters are used to demonstrate approaches that could be taken in doing a
reproductive risk assessment. Research needs for screening methods, adequate dose-
response testing, toxicokinetics, endpoint development, and extrapolation methods are
identified. Finally, this paper discusses selected areas in which changes in reproduc-
tive risk assessment are anticipated, as well as the mechanism for influencing the na-
ture and extent of those changes. (NLM)
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"Assessment of Risk for Embryotoxic Effects of Chemicals by Combined
Application of In-Vivo and In-Vitro Test Systems
Matsumoto N
Twenty-fifth Annual Meeting of the Japanese Teratology Society,
Kyoto, Japan, July 11-13, 1985
Teratology (1985). 2 (3): 19B
BIOSIS COPYRIGHT: BIOL ABS. RRM Abstract mice urethane carcinogenesis lung
toxicity liver toxicity (NLM)
**
Assessment of Risks to Human Reproduction and to Development of the Human
Conceptus from Exposure to Environmental Substances
Galbraith WM; Voytek P; Ryon MG
EPA-600/9-82-00-.158 PP, 1982
(NLM)
**Biases in Research on Reproduction and Women's Work
Joffe M
Department of Clinical Epidemiology, London Hospital Medical College, UK
Int J Eoidemiol: Vol 14, ISS 1, 1985, pi 18-23
In the investigation of the possible reproductive effects of women's work, it is neces-
sary to take into account the various biases which may occur as a result of the complex
interaction between a woman's child-care responsibilities, work status, income and
other aspects of her life. This paper distinguishes four effects and suggests methods of
avoiding the resulting biases. Research in this area requires special care in design and
analysis. (NLM)
Biological Effects of Static Magnetic Fields: A Selective Review with
Emphasis on Risk Assessment
Easterly CE
Oak Ridge National Lab., TN
Department of Energy, Washington, DC
NTIS/DE82013350, 78p
Rather than focusing on literature per se, the current study determines the status of
magnetic field information that is applicable to risk assessment. Hence, an attempt is
made to identify both the literature that is useful to the goal of risk assessment and a
framework within which risk assessment methodologies can be derived. From this
selected review, it is concluded that three areas exist for which adequate information
can be found to begin modelling: disease induction, reproduction and development, and
cardiovascular response. The first two are supported by a combination of positive and
negative findings and the last by a calculational technique which utilizes the physi-
cally well-known principle of flow retardation for a conducting fluid moving through
a magnetic field. (ERA citation 07:048110) (NLM)
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"Chemical and Biochemical Dosimetry of Exposure to Genotoxic Chemicals
Wogan GN; Gorelick NJ
Department of Applied Biological Sciences, Massachusetts
Institute of Technology, Cambridge
Environ Health Pcrspect: Vol 62, 1985, p5-18
Epidemiologic studies designed to evaluate the health significance of environmental
chemicals are compromised by the lack of quantitative exposure data for individuals
in exposed populations. Monitoring data on levels of compounds in environmental
media often represent the only information available, and average population exposure
is therefore the only quantitative parameter that can be calculated. Biological
monitoring, i.e., measurements on cells, tissues or body fluids of exposed persons, has
the objective of defining the so-called "internal dose" or "effective dose" on an in-
dividual basis. Such measurements can be used to ensure that current or past exposure
does not entail unacceptable health risks, or can detect potentially excessive exposure
before the appearance of adverse health effects. Results obtained through this ap-
proach can be interpreted on an individual basis and also used to estimate for that in-
dividual the amount of chemical absorbed during a specific time interval or the
amount bound to critical sites. They may also be useful for characterization of com-
munity exposure by analyzing result s obtained in groups of individuals within the
general population. In this respect, biological monitoring data complement environ-
mental measurements but have certain advantages in estimating health risks. Most
importantly, the data obtained are more directly related to adverse effects and thus
provide a better estimate of risk than ambient monitoring. Biological monitoring also
takes into account absorption by all routes, integrates exposure from all sources, and
therefore can be used as a basis for estimate of total risk from multiple chemicals.
(NLM)
**A Comparison of How the United States and Canada Set Drinking
Water Regulations
Calabrese EJ
Division of Public Health, University of Massachusetts, Amherst
Reeul Toxicol Pharmacol: Vol 3, ISS 4, 1983, p417-27
How the United States and Canada approach the process and implementation of drink-
ing water standards is critically examined. Despite many similarities in their ap-
proaches to regulating drinking water contaminants, there are a number of important
differences, including approaches to dealing genotoxic versus presumed epigenetic car-
cinogens and selection of biostatistical quantitative risk assessment models. Such in-
ternational comparisons provide a valuable means to discern how others have at-
tempted to solve similar problems and thereby provide an excellent opportunity to test
the validity of one's own methodologies. (NLM)
Comparison of Types of Chemically Induced Genetic Changes in Mammals
Adler ID
Institute of Genetics, Neuherberg Federal Republic of Germany
Mutat Res: 115(3):293-321 1983
The present paper reviews the currently available in vivo systems for detection of
chemically induced mutations and chromosome aberrations and summarizes the data of
the relevant tests for mammalian germ-cell mutations (specific-locus test and heritable
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translocation test). The value of in vivo screening tests (somatic mutations and sperm
abnormalities) for predicting specific-locus mutations is illustrated by comparing dou-
bling doses. The results from the mammalian germ-cell mutation tests (specific-locus
test and heritable translocation test) constitute the base-line for an assessment of
predictability. Radiation and chemically induced specific-locus mutations differ in a
number of respects, suggesting ,a need for caution in making risk estimates for chemi-
cal mutagen exposures in terms of radiation-equivalent doses. In vivo nondisjunction
tests are discussed. Finally, unsolved problems and difficulties in generalizing qualita-
tive and quantitative correlations between test systems are outlined. It is concluded
that even qualitative predictions from data on somatic cells to germ cells are at best in-
secure because germ-cell specificity cannot be foretold, not to mention the fact that
quantitative extrapolations from the results of in vivo screening tests, in general, are
fraught with even more uncertainties. There is an acute need for collection of more
data from studies involving germ cells. (140 Refs) (NLM)
Conference on the Safety Evaluation of Chemicals
Nelson N
New York University, NY
CRISP/86/ES03820-01
U.S. Dept of Health and Human Services; Public Health Service;
National Inst. of Health, National Institute of Environmental
Health Sciences
CRISP Data Base National Institutes of Health
RPROJ/CRISP Here proposed is a series of three Workshop Conferences aimed at ex-
amining new and emerging methods for safety evaluation of chemicals; these
Workshops lead to published reports in book form. These are conducted by the Scien-
tific Group on Methodologies for the Safety Evaluation of Chemicals, an international
organization sponsored by the International Programme on Chemical Safety (IPCS) of
the World Health Organization (WHO) which includes the International Labor Or-
ganization (ILO) and United Nations Environmental Program (UNEP) and the Scien-
tific Committee on Problems of the Environment (SCOPE) of International Council of
Scientific Unions (ICSU). The Group has an international membership which en-
courages the review of difficult problems relating to methods for evaluating the ef-
fects of chemicals on human and non-human biota. These Workshops result in books
composed of commissioned, individualy authored papers and a Joint Report. The first
Workshop (now available from Wiley Publising Company) dealt with Methods for As-
sessing the Effects of Chemicals on the Reproductive Functions; the second, about to
be published, dealt with Quantitative Risk Assessment; the third, completed in August
1983, is now in final editing and deals with Methods for Assessing the Effects of Mix-
tures of Chemicals; the fourth, completed in August 1984, is also in final editing and
covered the Predictive Value of Short-Term Tests for Non-Genotoxic Effects. Can-
didate topics are proposed by the Executive Committee of SGOMSEC and chosen in
consultation with the Sponsors. Normally, one such Workshop is held each year follow-
ing 8-10 months of preparatory writing by the invited contributors. A main objective
is the specific identification of research needs for the improvement of methods for the
safety evaluation of chemicals. (NLM)
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Current Concepts in Reproductive Toxicology
Borzelleca JF
Department of Pharmacology and Toxicology,
Medical College of Virginia, Virginia Commonwealth
University, Richmond,
Clin Lab Med: Vol 4, ISS 3, 1984, p461-7
Data in recent decades suggest that reproductive impairment in humans and laboratory
animals is associated with exposure to certain chemicals and physical agents, the sig-
nificance of which has not been clearly defined. The epidemiologic and anecdotal
human data suggest that the association or correlation is coincidental or causative. Ex-
tensive research is necessary to establish causality. (NLM)
"The Decision-Point Approach for Systematic Carcinogen Testing
Weisburger JH; Williams GM
American Health Foundation, Naylor Dana Inst.
Disease Prevention, Valhalla, NY
Food Cosmet Toxicol: 19 (5), 1981, p561-566
KEEP COPYRIGHT: BIOL ABS. Advances in the understanding of the mechanisms of
chemical carcinogenesis suggest new approaches to the practical aspects of the bioassay
of carcinogens and regulatory impact, and to the determination of health risk. Chemi-
cal carcinogens have been classified on the basis of their specific properties as
genotoxic carcinogens or agents operating by epigenetic mechanisms. Genotoxic car-
cinogens require distinct qualitative and quantitative types of analysis since their fun-
damental mechanisms of operation are different from those of epigenetic agents. A
systematic decision-point approach to carcinogen testing provides for distinction be-
tween genotoxic and epigenetic carcinogens. The first set of data points involves the
following: structure-activity relationships;mutagenicity assays in prokaryotes;
mutagenicity assays in eukaryotes; tests for induction of DNA repair in eukaryotes;
tests for sister chromatid exchange; cell transformation. Not all of these have equal
sensitivity, specificity and reliability. The sequence of in vitro tests permits prelimi-
nary decision making. As a second series, limited, relatively rapid, in vivo assays in-
volve the following: skin-tumor induction in mice, with and without promotion; lung-
tumor induction in mice; breast-cancer induction in rats; identification of early lesions
in rodent liver. The data so obtained are considered for decision making and risk
analysis. As a last step, a traditional chronic bioassay may be needed only when
human exposure to the product is potentially high and/or continuous, or when the
above phases of testing have yielded unsatisfactory or, in the case of epigenetic agents,
negative results. More research is essential for the delineation of the effects of
epigenetic agents, some of which are most important in the etiology of human cancer.
(NLM)
"Definition of a Carcinogen as a Potential Human Carcinogenic Risk
Weisburger JH
Naylor Dana Inst. Dis. Prevent., Amer. Health Found., Valhalla, NY
Jon. J. Cancer Res. (GANN); Vol 76, ISS 12, 1985;1244-6
CBAC COPYRIGHT: CHEM ABS The data base required for risk assessment and the
protection of man against cancer hazards from suspect chems. involves systematic ac-
quisition of data and anal, of the following: (1) structure-activity relations, (2) results
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from a battery of short-term in vitro tests data that indicate genotoxicity, and (3) in
vivo bioassays indicating a high incidence of malignant neoplasms in mice, rats, and
(or) hamsters with a relatively short latent period. Human cancer risks are thereby
defined by studies that yield clear pos. results. (NLM)
Direct Mutagen Risk Assessment: The Development of Methods to
Measure Immunologic and Genetic Responses to Mutagens
Strauss GHS
Health Effects Research Lab., Research Triangle Park, NC
NTIS/PB85-160455, 39p
TD3: The review puts forward the concept of Direct Mutagen Risk Assessment
through a discussion of the development of methods with which to measure im-
munologic and genetic responses to mutagens. Mutagenicity risk assessment, in this
context, is the study of human somatic cell mutation occurring in vivo and is con-
sidered with attention to ideal criteria for detection of mutant cells. Immunotoxicity
is addressed particularly in terms of the possible carcinogenic consequences of im-
paired cutaneous cell-mediated immunity. A section of this review reports the
development and the exploitation of the Strauss-Albertini test for enumerating 6-
thioguanine-resistant peripheral blood lymphocyte variants. Another section presents
results from a system under development, designed to clone and quantitate mutant
lymphocytes taken directly from the body. The Clonal Assay of Lymphocyte
Mutagenesis (CALM) can confirm that variant cells are mutant and, potentially, could
be used comparatively to measure genotoxicity in human or animal lymphocytes after
in vivo or in vitro exposures to mutagens. (NLM)
**The Distinct Health Risk Analyses Required for Genotoxic Carcinogens
and Promoting Agents
Weisburger JH; Williams GM
Naylor Dana Institute for Disease Prevention, American Health
Foundation, Valhalla, NY
Environ Health Perspect: Vol 50, 1983, p233-45
(NLM)
"Editorial Introduction to Papers Produced by Committee 4 of ICPEMC
on Risk Estimates of Genotoxic Chemicals
Sobels FH
Mutat Res: 114:91, 1983
(NLM)
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"The Effect of Common Exposures on Reproductive Outcomes
Hogue CJ
Pregnancy Epidemiology Branch, Centers for Disease Control, Atlanta, GA
Teratoacnesis Carcinog Mutagen: Vol 4, ISS 1, 1984, p45-57
(NLM)
"Environmental Influences on Fertility, Pregnancy, and Development.
Field Studies: Lessons Learned
Whorton D
Teratoaenesis Carcinog Mutagen: Vol 4, ISS 1, 1984, p25-44
(NLM)
"Epidemiologic Detection of Low Dose Effects on the Developing Fetus
Kline J; Levin B; Stein Z; Susser M; Warburton D
New York State Psychiatric Institute
Environ Health Persoect: Vol 42, 1981, pi 19-26
Evaluations of the health effects of exposures in the workplace and environment have
broadened to include effects on reproduction, as well as on the development of cancer.
Models to assess risks associated with varying doses of exposure rest almost entirely on
data about cancer. In this paper, we discuss some distinctive features of reproduction
which bear on the interpretation of such models, when applied to reproduction, rather
than carcinogenesis. Dose-response curves describe the relationship between two ex-
posures (smoking and alcohol drinking) and two outcomes (spontaneous abortion and
birthweight) are used to illustrate some of the questions which arise in attempting to
determine a "safe" level of exposure. (NLM)
Epidemiologic Study of Reproductive Outcomes and Environmental Exposures
Wilcox A
NIEHS, NIH
CRISP/86/ES44003-08
U.S. Dept of Health and Human Services; Public Health Service;
National Inst. of Health, National Institute of Environmental Health Sciences
CRISP Data Base National Institutes of Health
RPROJ/CRISP The reproductive epidemiology project emphasizes the development
and application of new methods for measuring human reproductive damage.
Reproductive outcomes include fertility, sub-clinical early fetal loss, spontaneous
abortion, fetal growth, and birthweight. Each of these outcomes can be affected by
environmental factors, and represents a possible endpoint for studying the effects of
toxins on human reproduction. One major component of this project is the study of
fertility. Time-to-pregnancy is being developed as a potentially useful and sensitive
measure of fertility. For example, a strong relation between smoking and time-to-
pregnancy has been documented. Another approach to the measurement of fertility in-
volves the study of daily urine specimens from women who are trying to become
pregnant. By comparing the ovarian hormones in cycles which results in pregnancy
with hormones in infertile cycles, new methods may be developed for measuring fer-
tility impairment. These methods may be applicable to women not actively trying to
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conceive. A second component of this project is the study of very early pregnancy loss.
In a prospective study of 230 women who have stopped using birth control in order to
become pregnant, daily urine specimens are being collected to be tested for evidence of
pregnancy. This will provide the best available estimate of the extent of early preg-
nancy loss in humans. The risk of early loss will be studied in relation to common ex-
posures in this population, such as use of alcohol, tobacco, caffeine beverages and
medications. Work continues on the development of a new method for the analysis of
birth weight and perinatal mortality. (NLM)
Epidemiologic Study of Reproductive Outcomes and Environmental Exposures
Wilcox A
NIEHS, NIH
CRISP/85/ES44003-07
U.S. Dept of Health and Human Services; Public Health Service;
National Inst. of Health, National Institute of Environmental Health Sciences
CRISP Data Base National Institutes of Health
RPROJ/CRISP The reproductive epidemiology program emphasizes the development
and application of new methods for measuring and analyzing human reproductive
outcomes. Such outcomes include fertility, sub-clinical early fetal loss, spontaneous
abortion, fetal growth, and birthweight. Each of these outcomes can be affected by
environmental factors, and represents a possible endpoint for studying the effects of
toxins on human reproduction. One major component of this program is a prospective
study of early fetal loss among 200 women. Daily urine specimens are being collected
from women who have discontinued their use of birh control in order to become
pregnant. Urine assays for human chorionic gonadotropin are being used to estimate
the risk of early pregnancy loss among these women. A pilot study of the first 30
women enrolled found chemically evidence of four sub-clinical pregnancy losses. Risk
of early loss will be studied in relation to common exposures in this population, such as
use of alcohol, tobacco, caffeine beverages and medications. Another area of interest
is the possible usefulness of measuring fertility through retrospective estimates of
time-to-pregnancy. A pilot study using this approach has recently been completed.
Another pilot study is in progress that looks for sub-clinical conceptions among women
using lUD's as possible measure of human fertility. Work continues on the further
development of a new method for the analysis of birthweight. (NLM)
Establishment of Normal Human Liver Epithelial Cell Lines
Tong CC
Braton Biotech, Inc., Hawthorne, NY
CRISP/86/ES03806-01
U.S. Dept. of Health and Human Services; Public Health Service;
National Inst. of Health, National Institute of Environmental Health Sciences
CRISP Data Base National Institutes of Health
RPROJ/CRISP In the assessment of genotoxicity of environ-mental chemicals, a bat-
tery approach has been recommended. The testing battery in general includes bacterial
and rodent mammalian cells as target organisms. Data generated from our comparative
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evaluation of these approaches indicated that when comparison of the same or two dif-
ferent well defined endpoints was made but involving different metabolic activation
systems, qualitative difference in response was observed. To enable one to rationally
and critically evaluate the risk of environmental chemicals to human and to perform
the evaluation in an expeditious as well as economical manner, we propose to establish
permanent human liver cell lines with the eventual aim of providing a battery of
human liver cell lines for risk assessment. Specifically, we propose in Phase I of this
project to establish several normal continuously replicating human liver cell lines from
human primary hepatocyte cultures. Phase II of this project will be the full charac-
terization and validation of these established human liver cell lines as components of a
testing battery for risk assessment. This work is primarily relevant to the programs
sponsored by NCI, Cancer Treatment Program, Toxicology—development of human
somatic cell mutagenesis system; and by NIEHS. (NLM)
Evaluation of Embryotoxic Risks from Industrial Chemicals During Pregnancy
Spielmann H
Max von Pettenkofer Inst., Bundesgesundheitsamtes Berlin, Berlin
Geburtshilf e Frauenheilkd: Vol. 46, ISS 6, 1986, 335-9
Language: German
CBAC COPYRIGHT: CHEM ABS A review with 19 refs. of industrial chems. (A)
known to be embryotbxic in humans, (B) probably embryotoxic, (C) and not
embryotoxic at max. concns. permissible for occupational exposure (i.e.,8 h/day, 40
h/wk) (1, 8, and 18 substances, resp.). In group D are carcinogens without max. permis-
sible concns. (112 compds). In group E are 26 compds. under evaluation for
embryotoxicity in humans. (NLM)
Evaluation of Genotoxic Effects in Human Populations
Waters MD; Allen JW; Claxton LD; Garrett NE; Huang SL
Health Effects Research Lab., Research Triangle Park, NC
Northrop Services, Inc., Research Triangle Park, NC
NTIS/PB84-128982, 67p
TD3: There are demonstrable associations in experimental animals between DNA
damage in somatic cells and the development of cancer, and between DNA damage in
germ cells and the incidence of genetic disease in offspring. Thus, there is substantial
evidence of the need to detect and to quantitate chemically induced genetic damage in
humans in order to assess the potential for cancer and genetic disease. Current
methods for estimating human risk of cancer have been based on knowledge of human
exposure and epidemiological data. An alternative approach would base such estimates
of risk on knowledge of exposure and of damage to the DNA of human cells and
tissues. The principal difficulty in performing such assessments lies in the uncertainty
of translating information from tests for genetic damage in human cells and tissues
into reliable estimates of risk for cancer or genetic disease. This poster concerns: (1)
the development of mammalian cell methods that may be used ultimately to evaluate
genotoxic effects in humans and (2) our initial attempts to implement a
'parallelogram' approach whereby such methods can be used, collectively, to relate
quantitative information on genetic damage to quantitative estimates of risk for can-
cer or genetic disease. Prepared in cooperation with Northrop Services, Inc., Research
Triangle Park, NC. (NLM)
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*A Framework for Reproductive Risk Assessment and Surveillance
Omenn GS
University of Washington, Seattle
Teratogenesis Carcinog Mutagen: Vol. 4, ISS 1, 1984, pl-14
(NLM)
**Genetic and Nongenetic Events in Neoplasia
Stott WT; Reitz RH; Schumann AM; Watanabe PG
Toxicol. Res. Lab., Dow Chemical Midland, MI
Food Cosmet Toxicol: 19 (5), 1981, 567-576
KEEP COPYRIGHT: BIOL ABS. It has become increasingly evident that all chemical
carcinogens do not act via the same mechanism of tumorigenicity. Based upon the ex-
tent of a chemical's interaction with DNA, a general classification scheme of various
mutational and nonmutational theories of chemical carcinogenesis is presented. Com-
pounds that directly interact with DNA are classified as genotoxic, whereas those that
do not interact directly with DNA are classified as epigenetic carcinogens. Under each
general heading, several mutational and nonmutational mechanisms of carcinogenesis
are believed to be possible. Data are presented to support the existence of an
epigenetic-mutational theory of chemical carcinogenesis based upon recurrent
cytotoxicity. In this case, increased regenerative DNA synthesis in response to tissue
injury is believed to result in an enhancement of the normal spontaneous mutation
rate, conceivably leading to a cellular transformation. The carcinogenic risk posed by
such epigenetic carcinogens appears to differ greatly from that posed by genotoxic
carcinogens. Consideration of data concerning the possible mechanism of car-
cinogenicity of a chemical, along with pharmacokinetic data, will allow a better under-
standing of bioassay results and a more accurate assessment of carcinogenic risk.
(NLM)
"Guidance for the Evaluation, Risk Assessment and Control of Chemical
Embryo-Fetotoxins
Karrh BW; Carmody TW; Clyne RM; Gould KG; Portela-Cubria G;
Smith JM; Freifeld M
Journal of Occupational Medicine: June 1981, Vol. 23, No. 6, p397-399
This review of issues of concern to the occupational health professional and workplace
manager covers: scope of the problem; medical issues; assessment of intrinsic embryo-
foetotoxic potential; assessment of human exposure; assessment of risk; control of
chemicals posing a potential embryo-foetotoxic risk; legal issues. It is concluded that
application of the same toxicological considerations and control measures as are used
for other chemicals which present different toxic hazards, will prevent, or maintain at
safe levels, exposure of susceptible persons to embryotoxins and will not unnecessarily
restrict the opportunity for meaningful employment for any class of persons. (NLM)
Identification of Genotoxins in the Industrial Work Environment, In:
Chemical Mutagenesis, Human Population Monitoring and Genetic Risk Assessment
Anderson D
Prog Mutat Res: 3:201-224, 1982
(NLM)
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**In Vivo Reproductive and Mutagenicity Tests
Christian MS; Voytek PE
Environmental Protection Agency, Washington, DC
NTIS/PB82-221599
TD3: A review of current in vivo testing systems and procedures used for assessing
reproductive and heritable genetic hazards of chemicals is presented. A comparison is
made between the similarities and differences in protocols for reproductive effects
among the different regulatory agencies in the United States and countries belonging
to the Organization for Economic Cooperation and Development. Uses of in vivo
mammalian mutagenicity data for assessing potential human heritable genetic diseases
risk are also discussed and examples of how in vivo mutagenicity test systems can be
used to estimate risk are presented along with explanations of the various assumptions
employed. Prepared in cooperation with Argus Research Labs., Inc., Horsham, PA.
(NLM)
International Programme on Chemical Safety (IPCS)
Mercier M
World Health Organization, Div of Environmental Health,
Geneva, Switzerland
CRISP/86/ES02617-06
U.S. Dept of Health and Human Services; Public Health Service;
National Inst. of Health, National Institute of Environmental Health Sciences
CRISP Data Base National Institutes of Health
RPROJ/CRISP The International Programme on Chemical Safety (IPCS) was initiated
in 1978 as a cooperative venture of three United Nations agencies: the World Health
Organization (WHO), the United Nations Environment Programme (UNEP), and the In-
ternational Labour Organization (ILO). Managed by WHO, the Programme has as its
long-term objectives (1) to evaluate scientifically for international distribution the ef-
fects of chemicals on human health and the environment, (2) to develop reliable scien-
tific methods for international use in toxicity testing, epidemiological and clinical
studies, and risk assessment, (3) to promote and coordinate scientific cooperation
among international in-laboratory testing, epidemiological and clinical studies, re-
search on the biological mechanisms of chemical damage and on dose-response, (4) to
develop educational models and programmes for toxicology training by WHO member
countries, and (5) to develop models and methods for dealing with in-country and in-
ternational chemical accidents. In addition, the Programme is charged with manage-
ment of WHO committees which develop guidelines on exposure limits of chemicals in
foods, air and water, and collaborated with the UNEP International Registry of Poten-
tially Toxic Chemicals. Using staff and facilities of Lead and Participating Institu-
tions in cooperating countries the Programme has (1) initiated evaluations of the
biological and environmental effects of over 50 chemicals or groups of chemicals; (2)
developed collaborative international scientific methodological studies in several
priority areas (genotoxicity and carcinogenicity testing, prenatal exposures,
neurobehavioural toxicity, environmental epidemiology, reproductive toxicology, im-
munological response to carcinogens); (3) developed a European model for toxicology
training and initiated a comparison of this model with the needs of developing WHO
member countries and (4) developed draft model programmes for coping with chemi-
cal emergencies, as well as providing a variety of associated guidelines, data sheets,
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health alerts and other publications. Finally, the Programme has provided neutral
ground for the first meeting of Western (OECD, ECE) and an Eastern European
socialist (CMEA) international organizations for harmonization and synthesis of global
approaches to chemical safety. (NLM)
"Laboratory Tests for Human Male Reproductive Risk Assessment
Overstreet JW
School of Medicine, University of California, Davis, CA
Teratoeenesis Carcinog Mutagen: Vol. 4, ISS 1, 1984, p67-82
The criteria for reproductive test selection which were set forth in the beginning of
this chapter required that the tests be objective, technically sound, biologically stable,
sensitive and feasible. All of the tests which have been discussed can generate objec-
tive quantitative data (Table 1). Testicular tonometry appears to be a technically
sound procedure which measures a biologically stable parameter, although this remains
to be proven. Sperm counts are definitely not a biologically stable parameter. There is
insufficient information to judge the biological stability of data obtained from sperm
cervical mucus interaction. Data from a number of laboratories suggest that the zona-
f ree hamster egg assay gives stable results when repeated with the same donor, and the
tests as performed in specialized laboratories are technically sound at the present time.
However, the number of laboratories which can perform the assay is limited. Sen-
sitivity to early toxicity is a very important criterion for test selection. Physical ex-
amination does not meet this criterion, endocrine studies do not, and sperm counts do
not. Not enough information is currently available to determine the sensitivity of
sperm motility assessment. Sperm morphology assessment may be the most sensitive
early indicator of reproductive toxicity which is currently available. There is a large
body of clinical and basic science literature which suggests that sperm morphology may
reflect acute stress effects on the testes. The feasibility of these tests vary. Sperm
motility may be feasible only in longitudinal studies in which the video equipment can
be set up in a laboratory which is doing repeated assessments. Sperm morphology
assessment does not require any specialized equipment in the field. Studies of sperm
cervical mucus interaction, for the reasons already stated, remain non-feasible at this
time. Tests of sperm-egg interaction are probably feasible if spermatozoa can be
shipped to a specialized laboratory for assessment. Thus, there are now a number of
new tests for male reproductive function which are available, and which are practical.
It is time for this technology to be transferred from the basic science laboratory for
application in human reproductive risk assessment. (NLM)
"Measurement of in Vivo Mutant Frequency in Lymphocytes in the Mouse
Dempsey JL; Morley AA
Dep. Haematol, Flinders Med. Cent., Bedford Park
Environ Mutaeen: Vol 8, ISS 3, 1986, 385-91
CBAC COPYRIGHT: CHEM ABS A limiting-diln. cloning technique for quantifying
in vivo mutations at the hypoxanthine phosphoribosyltransferase locus in mouse
splenocytes was developed. Mouse splenocytes were cultured in round-bottom
microwells with irradiated feeder cells, concanavalin A, and a source of interleukin 2
at 5 cells/well in the absence of thioguanine, and at 5 .times. 104 cells/well in the
presence of 2.5 mug/mL thioguanine; mutant frequency was calcd. as the ratio of the
cloning efficiencies with or without thioguanine. The geometric mean (95% range) for
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the mutant frequency in 20 mice was 1.54 .times. 10-6 (4.7 .times. 10-7-2.6 .times. 10-6)
and whole-body x-irradn. resulted in a dose-related increase in mutant frequency of up
to .apprx. 20 times the baseline level. The in vivo murine mutation assay should be a
useful system for genotoxicity testing and may be of particular value in establishing
risk ests. for human populations exposed to genotoxins. (NLM)
Mechanisms of Chemical Carcinogenesis: Recent Advances
Fournier PE; Thomas G
Clinique Toxicologique, Hopital Fernand Widal, Paris
Food Addit Contam: Vol. 1, ISS 2, 1984, p73-80 (Refs 53)
The carcinogenetic risk assessment of veterinary drugs has to be envisaged as part of
food toxicology. The authors review the recent discoveries which have proved sig-
nificant for the toxicologist. Tumours arise from an inherited transformation of nor-
mal cells through genotoxic, perigenetic and epigenetic processes. Genotoxic
mechanisms are best understood and have led to the development of short-term
reference tests. The biochemistry of DNA alterations is being unravelled and permits
quantitative estimation of carcinogenetic potencies. Work on the role of oncogenes is
providing new clues to the understanding the mechanisms of chemical carcinogenesis.
Perigenetic processes deal mainly with DNA repair systems and emphasize the com-
plexity of human genome dynamics. Experimental findings about epigenetic
mechanisms are still inconclusive as to their practical implications. Abnormal expres-
sion of HLA-antigens at the surface of neoplastic cells has been reported, but its sig-
nificance is still unknown. In conclusion, the main source of progress in toxicology
undoubtedly comes from molecular biology, but experimental results must be inter-
preted with caution if practical issues are to be derived from them. (NLM)
Mechanisms of DNA Damage and Repair: Implications for Carcinogenesis
and Risk Assessment
Simic MG; Upton AD (Eds.)
U.S. National Bureau of Standards
New York, Plenum Press, c. 1986
Type Document: Series: Basic Life Sciences, Volume 38
Misinterpretations of Results and Creation of Artifacts in Studies
on Developmental Toxicity Using Systems Simpler than In Vivo Systems
Neubert D; Blankenburg G; Lewandowski C; Klug S
Inst. Toxikol. Embryopharmakol., Freie Univ. Berlin, Berlin
Prog. Clin. Biol. Res: Vol 171, ISS Dev. Mech. Norm.
Abnorm., 1985, 241-66
CBAC COPYRIGHT: CHEM ABS A discussion is presented of the limitations of in
vitro studies for risk assessment of chems. for human prenatal development. In vitro
systems are valuable for evaluating the mode of action of known embryotoxic sub-
stances and for supplementing in vivo studies. Up to now, only a small area of
reproductive toxicol. can be covered by in vitro tests. Since the mechanisms of abnor-
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mal mammalian development are only incompletely understood, it is difficult to
develop a simple system for the testing of all possibilities of abnormal development.
None of the available systems had been properly validated for routine testing or for
replacing in vivo testing. (NLM)
Modelling Cellular Responses to Genotoxic Agents (Hamsters)
Wilson JD
Medical College of Virginia, Richmond, VA
CRISP/86/ES02992-03
U.S. Dept. of Health and Human Services; Public Health Service;
National Inst. of Health, National Institute of Environmental Health Sciences
CRISP Data Base National Institutes of Health
RPROJ/CRISP There are areas of significance to human health in which it is neces-
sary or desirable to examine biological effects that involve the interaction of multiple
agents. For example, improved cancer treatment may be achieved through the combina-
tion of multiple chemotherapeutic agents or the use of several conventional treatment
modalities. Similarly, proper assessment of the potential risks posed by the increasing
accumulation of hazardous materials in the environment should include the ability to
examine the effects of exposure to multiple toxic agents since this is often the situa-
tion in nature. Conventional experimental designs and methods of analysis have
several disadvantages in these types of studies. The experiments are necessarily large
and therefore technically unwieldly and expensive. In addition, the analysis of data
rapidly becomes extremely complex as the number of agents increases. The objective
of this proposal is to develop and apply mathematical and statistical techniques which
comprise response surface modelling to the study of biological effects resulting from
exposure to various combinations of chemical and/or physical agents. Response sur-
face analysis has proven to be a useful tool in combination chemotherapy studies using
animal models; this will be the first attempt to apply these techniques to in vitro
biological systems. Cell lethality, mutation and sister chromatid exchange will be the
biological responses examined. These effects will be quantitated in V79 Chinese
hamster fibroblasts using standard procedures following exposure of the cells to ioniz-
ing radiation, heat and chemicals in various combinations. Aspects of response surface
methodology will include selecting the appropriate experimental designs, fitting multi-
dimensional response surfaces to experimental data and exploring the response surfaces
in regions of particular interest. A major aim is to use this approach to detect statisti-
cally significant interactions that occur between the agents used to produce the various
responses. These techniques may result in new ways to improve the technical
feasibility and cost effectiveness of in vitro experiments designed to optimize the use
of therapeutic agents or to test mixtures of potentially harmful environmental agents
utilizing presently available screening systems. (NLM)
Models to Man: Establishment of Reference Points for Estimating Genetic
Risk in Man, In: Indicators of Genotoxic Exposure
Mohrenweiser HW; Neel JV
Banbury Rep; 13:471-486, 1982
(NLM)
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"Monitoring and Risk Assessments of Exposures to Genotoxic Agents
Osterman-Golkar S
Acta Pharmacol Toxicol: 49(Suppl 1):12, 1981
(NLM)
The Mouse Spot Test as a Predictor of Heritable Genetic Damage
and Other Endpoints
Russell LB
Biol. Div., Oak Ridge Natl. Lab., Oak Ridge
Chem Mutaeens: Vol 8, 1983, 95-110
CBAC COPYRIGHT: CHEM ABS The mammalian spot test (MST) and the specific-
locus test (SLT) both detect various intragenic and chromosomal changes at marked
genetic loci in somatic and germline cells, resp. The assay of scorable genetic events is
broader in the MST. The unit mutation rate (i.e., induced rate/locus/mol) for 15 chems.
was tested with both the MST and SLT. The MST gave no false negs. for heritable
mutations induced in spermatogonial stem cells in post-stem cell stages. The unit rate
for MST was, with one exception, greater than or similar to that for the SLT. The SLT
provided the more pertinent data for assessment of risk from heritable point
mutations, the MST being merely a prescreen. Ancillary results with the MST can
provide indicators of cytotoxicity, embryotoxicity, or teratotoxicity, but the magnitude
of these effects shows no clear correlation with mutagenic potency. (NLM)
Mutagenicity in Drug Development: Interpretation and Significance of Test Results
Clive D
Genetic Toxicology Laboratory, Wellcome Research Laboratories,
Research Triangle Park, NC
Regul Toxicol Pharmacol: 5(1):79-100 1985
The use of mutagenicity data has been proposed and widely accepted as a relatively
fast and inexpensive means of predicting long-term risk to man (i.e., cancer in somatic
cells, heritable mutations in germ cells). This view is based on the universal nature of
the genetic material, the somatic mutation model of carcinogenesis, and a number of
studies showing correlations between mutagenicity and carcinogenicity. An uncritical
acceptance of this approach by some regulatory and industrial concerns is over-
conservative, naive, and scientifically unjustifiable on a number of grounds: Human
cancers are largely life-style related (e.g., cigarettes, diet, tanning). Mutagens (both
natural and man-made) are far more prevalent in the environment than was originally
assumed (e.g., the natural bases and nucleosides, protein pyrolysates, fluorescent lights,
typewriter ribbon, red wine, diesel fuel exhausts, viruses, our own leukocytes). "False-
positiye" (relative to carcinogenicity) and "false-negative" mutagenicity results occur,
often with rational explanations (e.g., high threshold, inappropriate metabolism, in-
adequate genetic endpoint), and thereby confound any straightforward interpretation
of mutagenicity test results. Test battery composition affects both the proper iden-
tification of mutagens and, in many instances, the ability to make preliminary risk
assessments. In vitro mutagenicity assays ignore whole animal protective mechanisms,
may provide unphysiological metabolism, and may be either too sensitive (e.g., testing
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at orders-of-magnitude higher doses than can be ingested) or not sensitive enough (e.g.,
short-term treatments inadequately model chronic exposure in bioassay). Bacterial
systems, particularly the Ames assay, cannot in principle detect chromosomal events
which are involved in both carcinogenesis and germ line mutations in man. Some com-
pounds induce only chromosomal events and little or no detectable single-gene events
(e.g., acyclovir, caffeine, methapyrilene). In vivo mutagenicity assays are more
physiological but appear to be relatively insensitive due to the inability to achieve suf-
ficiently high acute plasma levels to mimic cumulative long-term effects. Examination
of the mutagenicity of naturally occurring analogs may indicate the irrelevance of a
test compound's mutagenicity (e.g., deoxyguanosine and the structurally related an-
tiviral drug, acyclovir, have identical mutagenicity patterns). Life-threatening or
severe debilitating diseases (e.g.,cancer, severe psychoses, severe crippling arthritis,
sight-threatening diseases) may justify treatment with mutagenic or even carcinogenic
therapeutic agents (benefit/risk considerations). (NLM)
Murine Lymphocyte SCE Model for Predicting Genotoxic Risk (Mice)
Conner MK
University of Pittsburgh, Pittsburgh, PA
CRISP/86/CA39401-01
U.S. Dept of Health and Human Services; Public Health Service;
National Inst. of Health, National Cancer Institute
CRISP Data Base National Institutes of Health
RPROJ/CRISP Analysis of sister chromatid exchange (SCE) in peripheral blood lym-
phocytes (PBLs) is commonly used as an indicator of genotoxic exposures of human
populations. The primary goal of this proposal is to test the hypothesis: The accumula-
tion of unrepaired SCE-inducing lesions and their persistence in PBLs, produced by
repeated chemical exposure, are directly related to the agent's tumorigenic activity.
Due to inherent limitations of human studies any association of acute or persistently
elevated SCEs in human PEL and genotoxic damage in critical body tissues and/or car-
cinogenesis is, at best, inferred. Therefore, as a means of testing our hypothesis we
describe a parellelogram approach which: 1. Compares murine and human PEL SCE
responses to a known carcinogen, L-phenylalanine mustard (L-PAM), and 2. Compares
murine PLB SCE responses to responses in other critical tissues following treatment of
mice with chemicals of varying carcinogenic activities. For the first part of this study
a very large L-PAM treated patient SCE data base is available from a local study. This
enables us to design equivalent murine L-PAM treatment protocols in order to deter-
mine whether the same general post-treatment trends in SCE responses are observed in
human and murine PLSs. In the second part of the study, L-PAM and, if time permits,
other alkylating agents will be administered to mice using the established lung
adenoma assay protocol. SCEs will be evaluated in PBLs, spleen, lymph node, and
thymus lymphocytes at various time intervals (24 hrs - 15 wks) after the last treatment.
The following questions will be addressed: Successful evaluation of the proposed
animal model will provide the basis for future studies. For example, a chemical which
produces ambiguous SCE results in humans can be more completely evaluated at high
and low doses in the animal model in order to determine human genotoxic risk. In
addition, new chemicals can be evaluated in the animal model in order to predict
genotoxic risk prior to widespread human exposure. (NLM)
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Occupational Reproductive Hazards: Necessary Steps to Prevention
Infante PF; Tsongas TA
Health Standards Programs, Occupational Safety and Health
Administration, Washington, DC
Proa Clin Biol Res: Vol. 117, 1983, p383-90
Although some attention has recently been given to the study of occupational
reproductive hazards, little is known about measures being taken to prevent exposure
to substances having the potential to cause such problems. In the past, OSHA has
promulgated a standard to lower the permissible exposure level to a reproductive toxin
as the major focus only after experimental evidence was confirmed in humans. The
method of selection of appropriate substitutes is also cause for concern. A chemical
known to cause testicular atrophy, cancer, and gene mutations in subhuman test sys-
tems and to cause sterility in male workers was replaced with a substance known from
experimental studies to cause testicular toxicity, cancer of multiple sites, and gene
mutations. Experimental test results need to be addressed from the standpoint of
determining presumptive risk to humans. A scheme for setting priorities for reduction
of exposure or for consideration of regulation of occupational reproductive hazards
also needs to be developed. A policy addressing occupational reproductive hazards
may serve as a stimulus for protecting workers from these hazards and for improving
scientific research protocols. (NLM)
Occupational Risks of Pesticide Exposure for Females
Swartz WJ
Louisiana State Univ. Medical Center, New Orleans, LA
National Inst. for Occupational Safety and Health, Cincinnati, OH
NTIS/PB84-241645, 16p
TD3: The effects of pesticides on the female reproductive system were studies in chick
embryos and mice. Carbaryl (63252) was administered to chick embryos in doses of 1.0
to 10.0 milligrams (mg) for 5 or 12 days. When exposed for 12 days, carbaryl became
increasingly embryotoxic and abnormalities such as subcutaneous edema and defects in
the hind limbs were observed. Female mice were given 50mg per kilogram (kg) DDT
(50293) orally once a week for 4 weeks. They were then treated with gonadotropins.
Mice were treated with malathion (121755) using the same protocol as with DDT.
Malathion did not affect the number of eggs ovulated in response to gonadotropins.
The author concludes that DDT has a significant effect on the female reproductive
system. Progress rept. 1 Apr 79-31 Mar 82. (NLM)
Overall Design Considerations in Male and Female Occupational Reproductive Studies
Sever LE; Hessol NA
Pacific Northwest Laboratory, Richland, WA
Prog Clin Biol Res: Vol. 160, 1984, pi5-47
Epidemiqlogic studies are extremely useful for examining the possible relationships be-
tween occupational exposures and reproductive outcomes in occupational populations.
In this paper, we examine some of the major epidemiologic design considerations in
male and female occupational reproductive studies. An important consideration in all
epidemiologic studies is to choose appropriate outcome variables. One of the unique
characteristics of reproductive studies is the wide range of potential outcome variables:
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from problems of infertility, through fetal development, and into childhood diseases
and diseases of young adulthood. Usually, it is infeasible to look at all possible
outcomes. By omitting certain outcomes, however, important associations between ex-
posure and outcome may remain undetected. Epidemiology relies on observations of
populations. Factors in data availability, collection, and analysis, and in study design
often limit the inferences that may be drawn. The "exposed" or "at risk" groups are not
likely to be randomly selected and the investigator has little control over the exposures
of the study population. Unlike experimental investigations, epidemiologic observa-
tions are made on individuals exposed to a variety of hazards during their lives. The
size of the population available for study is critical. Bias potential confounding fac-
tors can be minimized through the use of appropriate matching and/or statistical
techniques. Many of the topics discussed here will be expanded in subsequent chapters.
Although this paper is designed to assist in planning occupational epidemiologic
studies, we strongly recommend that, when attempting to conduct such studies, profes-
sional guidance from epidemiologists and biostatisticians be obtained. (NLM)
Policy and Procedures for Using Mutagenicity Data in Assessing
Genetic Risk, In: Genotoxic Effects of AirborneAgents
Voytek P
Environ Sci Res: 25:579-588, 1982
(NLM)
Preliminary Investigation of the Parallelogram Concept in Genetic
Monitoring and Risk Estimation
Waters M; Allen J; Doerr.C; Tabor J; Wilmer J
Health Effects Research Lab., Research Triangle Park, NC
Environmental Health Research and Testing, Inc., Research Triangle Park, NC
Northrop Services, Inc., Research Triangle Park, NC
Chemical Industry Inst. of Toxicology, Research Triangle Park, NC
NTIS/PB86-102332, 16p
TD3: The main objective of genetic monitoring in human health surveillance is to
prevent excessive exposure to genotoxic agents and to ensure the safety of the exposed
or potentially-exposed populace. To attain fully this objective one must understand
low dose exposure and associated effects so as to relate both to long-term health
consequences. Experience with radiation has provided the most precise knowledge of
the dose-effect relationship, and it is that knowledge that the authors wish to exploit
in the present investigation. Over the past few years the laboratory has implemented
and further developed several methods for cytogenetic and mutational testing and
monitoring. These methods employ periphral blood lymphocytes and fibroblasts to
detect chromosomal structural aberrations, sister-chromatid exchanges, and gene muta-
tion at specific genetic loci. (NLM)
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Principles for Evaluating Health Risks to Progeny Associated With Exposure
to Chemicals During Pregnancy
World Health Organization, Geneva, Switzerland
Environ Health Criteria: 30:1-177 1984
Principles for evaluating health risks to progeny associated with exposure to chemicals
during pregnancy are discussed in order to aid in the design and assessment of such
studies. Personal tragedies are involved when defects are present at birth or appear
later in life, and the need for improved methods for the detection of embryo/fetal
toxic agents, the assessment of health risks, and the prevention of unfavorable out-
comes in pregnancy is evident. There ate many difficulties involved in extrapolating
human risk from animal studies. In recent years, it has become clear that considera-
tion of developmental toxicity following prenatal exposure must be expanded to in-
clude chemically-induced embryolethality, reduced fetal growth, and functional altera-
tions that may not be expressed until late after delivery. Some chemicals may decrease
fertility by causing a loss of the early conceptus, even before pregnancy is suspected.
The processes of cellular and morphogenic differentiation, though poorly understood,
offer many potential targets for toxic chemicals. The use of laboratory data in defin-
ing potential embryotoxic hazards of chemicals and methods of assessing the human
risks associated with occupational or environmental exposure to such chemicals are
described. Three major areas are covered, including prenatal toxic manifestations,
postnatal manifestations, and short-term tests. Background information on the
mechanisms of development is provided. Methods of assessing prenatal toxic manifes-
tations are described. Discussions about postnatal events and short-term tests are
included. The potential of available tests is reviewed and human risk assessments are
considered. Conclusions and recommendations are presented. Explanations of terms
used in the document are provided. This document primarily deals with chemical ex-
posures during pregnancy and should be useful to all those concerned with evaluation
of chemical safety. (NLM)
"Proposed New Teratogenic Risk Assessment Bioassay System Utilizing Hydrozoans
Clemens, GR; Martin, VJ
Society of Environmental Toxicology and Chemistry Sixth Annual
Meeting 8545010 St. Louis, MO, 10-13 Nov 1985
Society of Environmental Toxicology and Chemisty (SETAC), Rockville MO
No formal proceedings will be published. Many of the papers will be published in the
Society journal - Environmental Toxicology and Chemistry. (CPI)
Protecting the Reproductive Health of Workers: Problems in Science and
Public Policy
Valentine JM; Plough AL
Boston University
J Health Polit Policy Law: Vol. 8, ISS 1, 1983, p!44-63
This paper first reviews the scientific problems involved in assessing the effects on
reproductive health of toxic substances in the work environment. It then describes the
current status of regulatory policies designed to control workers' exposures to toxins
believed to affect reproduction. Finally, the paper discusses the relationship between
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scientific uncertainty and regulatory strategies. Because demonstrating reproductive
health effects is extremely difficult, the assessment of the health risks of exposures, as
well as of the economic costs of regulation, is probabilistic. Therefore, uncertainty is
inherent in any regulatory decision in this area. And the case of reproductive risks is
illustrative of the more general problem of protecting the health of workers within a
context of scientific uncertainty, and within a highly charged political environment
characterized by anti-regulatory sentiment and industries in economic decline. (NLM)
"Recognition, Evaluation, and Control of Chemical Embryotoxins in the Workplace
Smith JM; Costlow RD
Rohm and Haas Company, Spring House, PA
Fundam ADD! Toxicol: Vol. 5, ISS 4, 1985, p626-33
(NLM)
"Regulatory Aspects of Teratology: Role of the Food and Drug Administration
Kelsey FO
Food and Drug Administration, Rockville, MD
Teratology: Vol. 25, ISS 2, 1982, pi93-9
The Food and Drug Administration is a scientific regulatory agency whose consumer
protection activities cover a wide range of products including foods and additives, and
pesticide residues on foods; drugs; cosmetics; medical devices; and radiation-emitting
electronic products. Amongst its concerns is the possible teratogen effects of regulated
products to which the pregnant woman is exposed. The policies and programs of the
agency directed toward reducing such risks to the unborn are reviewed. These
measures include guidelines for animal reproduction studies and for clinical trials in-
volving women to childbearing potential; labeling of products to disclose known or
possible harm to the fetus or embryo; surveillance procedures designed to detect pre-
viously unsuspected adverse effects of marketed products; research activities designed
to develop better understanding of developmental toxicology and improved techniques
for detecting embryocidal and embryotoxic effects; and educational efforts directed
both to professionals and the public regarding hazards to the unborn of agency-
regulated products. (NLM)
**A Report of the U.S. Environmental Protection Agency Gene-Tox Program.
Evaluation of Mutagenicity Assays for purposes of Genetic Risk Assessment
Russell LB; Aaron CS; de Serres F; Generoso WM; Kannan KL;
Shelby M; Springer J; Voytek P
Biology Division, Oak Ridge National Laboratory, TN
Mutat Res: Vol. 134, ISS 2-3, 1984, p!43-58
For the vast majority of chemicals, mammalian germ-line (MG) mutation data do not
exist. The question was examined of how best to utilize results of non-MG
genotoxicity assays that are included in the Gene-Tox data base to provide information
of the likelihood that genetic damage might be induced in and transmitted by the
reproductive cells of exposed human beings. Two approaches were used to assess the
relative value of different assays for genetic hazard identification. (1) Test results
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were weighted according to parameters by which an assay resemble those encountered
in the potential induction of transmitted genetic damage in mammals. For this
purpose, 35 assays were grouped into 16 categories that were assigned weights ranging
from 1 to 15; there were 2367 chemicals in the data base. This system was evaluated by
comparing the sum of weighted test results for each chemical with the outcome of MG-
standard (MGst) tests where such had been reported. (MGst tests used were the specific-
locus and heritable-translocation assays [SLT and HTT] for gene mutations and
chromosome aberrations, rekspectively.) The weighting system produced ka few false
positives with respect to the MGst results. It produced no false negatives, but the
available evidence is limited by the circumstance that MGst test have evidently been
preferentially performed with chemicals that had alread been shown to be positive in
several other assays. (2) Finds from each MGst test were compared with those from
each of the other assays in turn, provided that at least 10 chemicals had been tested in
both of the assays. There were 11 such comparisons involving the SLT, and 14 such
comparisons involving the HTT. The observed concordance was above random expec-
tation in several comparisons, particularly those involving certain mammalian in vivo
tests, but in only one case (HTT vs. unscheduled DNA synthesis in the testis) did the
degree of elevation approach statistical significance. (NLM)
Reproductive Toxicity Risk Assessment of Chemicals
Rao KS; Schwetz BA; Park CN
Dow Chemical
Veterinary & Human Toxicology. Jun 81, V23, N3, p!67(9)
Type Document: Technical Report
The goals of reproductive toxicology are to predict adverse effects in humans from
chemical exposure through evidence garnered from animal studies. Factors that must
be considered in risk evaluation of environmental agents are discussed. Basic ter-
minologies are produced and data are statistically evaluated. (9 Refs., 1 Table)
(ENVL)
"Reproductive Toxicology
Dixon, RL
New York, Raven Press, 1985
Type Document: Series: Target Organ Toxicology Series
Keywords: Genetic Toxicology; Reproduction/Drug Effects;
Health Risk Assessment
EPA Libraries: ELB Cinn
Call Number: RA1224.3.R46 1985
Risk and Reason, Risk Assessment in Relation to Environmental Mutagens
and Carcinogens
Proceedings of a Satallite Symposium to the Fourth
International Conference on Environmental Mutagens, Oslo, Norway,
June 21-22, 1985.
Proe Clin Biol Res: 208:1-189 1986
(NLM)
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"The Role of Genotoxic Carcinogens and of Promoters in Carcinogenesis
and in Human Cancer Causation
Weisburger JH; Wynder EL
Naylor Dana Institute for Disease Prevention, American
Health Foundation, Valhalla, NY
Acta Pharmacol Toxicol (Copenh); Vol 55 Suppl 2, 1984,
P53-68 (REF: 67)
The majority of human cancers have multifactorial environmental causes stemming
mainly from lifestyle factors such as use of tobacco products through cigarette
smoking, snuff dipping, or chewing, and specific nutritional elements and dietary
practices. The mechanisms of these lifestyle factors can be analyzed in terms of
specific genotoxic carcinogens, and of epigenetic agents or promoting factors. Tobacco
and tobacco smoke contain not only genotoxic carcinogens but also, with a more impor-
tant ultimate effect, cocarcinogens and promoters. Alcohol acts as a cocarcinogen with
tobacco, possibly by modifying the metabolism of carcinogens in select organs.
Genotoxic carcinogens as nutritional factors may be found in pickled, salted, and
smoked foods and may be responsible for gastric cancer. Vitamins C and E and other
antioxidants are effective inhibitors. Other types of genotoxic carcinogens are
mutagenic chemicals found in broiled and fried foods, and these may be involved in
cancer of the colon, breast, and prostate. Promoting effects derive from a high level of
dietary fat, which has been linked epidemiologically and through laboratory studies to
a higher risk for these cancers. Possible mechanisms by which fat exerts its effects are
an increased concentration of bile acids in the stool, as related to colon cancer, and
which may be countered by a high cereal fiber diet, to increase stool bulk. In relation
to breast or prostate cancer, fat may exert its effect on complex hormonal balances,
and also on membrane composition. These promoting effects, whether associated with
tobacco smoke or nutrition, are highly dose-dependent, and provided the insult is not
too far advanced, reversible. Thus, lowering the dosage, or eliminating the effect as in
smoking cessation should have an appreciable effect in reducing overt disease
development, and do so fairly promptly. This may apply also to a reduction of second
disease in cases where a first occurrence has been successfully treated by conventional
means. (NLM)
**The Role of Surveillance in Monitoring Reproductive Health
Rosenberg MJ; Halperin WE
National Institute for Occupational Safety and Health,
Centers for Disease Control, Cincinnati, OH
Teratogenesis Carcinog Mutaeen: Vol 4, ISS 1, 1984, pi5-24
(NLM)
"Screening of Potential Reproductive Toxicants by Use of Porcine Granulosa
Cell Cultures
Haney AF; Hughes SF; Hughes CL, Jr.
Duke Univ. Med. Center, Durham, NC
Toxicology: 30 (3). 1984. p227-242
KEEP COPYRIGHT: BIOL ABS. While 60,000 chemicals are in widespread use with
1,000 new chemicals introduced into the environment each year, the biologic effects of
these agents are poorly understood. With the specific goal of testing for potential
reproductive toxicity, methodology was established for the screening of compounds in
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vitro by measuring effects on progesterone production by porcine granulosa cells in
culture. Granulosa cells were harvested by mechanical agitation, cryopreserved and
cells with known progesterone production by porcine granulosa cells in culture.
Granulosa cells were harvested by mechanical agitation, cryopreserved and cells with
known progesterone production capacity utilized for culture. Agents to be tested were
added to cultures of 105 cells and the media assayed for progesterone by
radioimmunoassay. Estradiol suppression of protesterone production was easily
demonstrated in this system and utilized as a verification of responsiveness. The pes-
ticide o, -p-DDT and its isomer p,p-DDt produced dramatic suppression of progesterone
production apparently with equal potencies to estradiol. The pesticides malathion,
parathion and dieldrin and the fungicide hexachlorobenzene were without effect in
this test system. Rapid and efficient screening of potential reproductive toxicants can
be performed with the porcine granulosa cell culture system. Mechanisms by which
toxicants produce their effect in the system are not elucidated although both estrogenic
and non-estrogenic actions must be considered. Since granulosa cells play a central role
in mammalian reproduction, this screening system in vitro should aid in identification
of agents at high risk for reproductive effects. Eventual utility Eventual utility of
this screen will depend on confirmation of reproductive hazard in vivo of agents iden-
tified as toxic in vitro, and dieldrin and the fungicide hexachlorobenzene were
without effect in this test system. (NLM)
Short-term Tests in the Framework of Carcinogen Risk Assessment to Man
Kroes R
Institute CIVO-Toxicology and Nutrition TNO, Zeist, the Netherlands
Ann NY Acad Sci: Vol. 407, 1983, p398-408
Short-term tests designed to detect possible carcinogenicity have been extensively
refined during the last years. Presently, many more or less simple and convenient sys-
tems are available to detect mutations, chromosome effects, DNA damage, and malig-
nant transformation. Although their relevance to carcinogenicity is often reasonably
good, inconsistencies in the pattern of response indicate that their role as predictive
indicators of carcinogenicity is still uncertain. The use of short-term tests in car-
cinogen risk assessment does seem feasible. These tests, however, should not be the
only characteristic taken into consideration in such a risk assessment. Other charac-
teristics such as chemical structure, biotransformation, and pharmacokinetics, qualita-
tive and quantitative physiological and/or morphological effects, species, strain, and
organ specificity, dose-response relation, and information on human studies, if
available, are of importance too. Current knowledge does not permit a rigid class-
ification of carcinogens, but does warrant a subclassification into genotoxic and non-
genotoxic compounds. Whereas for genotoxic compounds a real threshold cannot be
expected on a theoretical basis, the existence of a threshold may well be expected for
nongenotoxic compounds. In conjunction with other characteristics it may then be
decided whether a genotoxic or nongenotoxic compound may be or may not be per-
mitted in the human environment. In this evaluation process it is anticipated that for
genotoxic compounds other extrapolation systems should be used, as compared to non-
genotoxic compounds, where in fact a conventional food toxicology safety factor may
be applied. Short-term tests are very important in the subclassification with respect to
genotoxicity and seem to be of value for the detection of promoter activity as well.
(NLM)
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Statistical Methodology and Analysis of Mutagenesis Testing Data
Margolin BH; NIEHS, NIH
U.S. Dept of Health and Human Services; Public Health Service;
National Inst of Health, National Institute of Environmental Health Sciences
CRISP Data Base National Institutes of Health
RPROJ/CRISP During the last decade the science of genetic toxicology has ex-
perienced dramatic growth in its volume of experimentation, its variety of assays, and
its level of public awareness. This growth, in all its dimensions, is attributable to the
ability of these short-term tests to detect, rapidly and relatively inexpensively, en-
vironmental agents that are genotoxic. These agents are thought to be implicated in
such diverse human health problems as cancer, aging and birth defects. Scientific re-
search in genetic toxicology, however, is far from mature; much remains to be achieved
in terms of understanding the precise implications of results from such tests for the
assessment of risks to human health. To this end, it is important that there be objec-
tive methods of analysis of assay system test results, so that subjective assessments do
not significantly interfere with the evaluation of the relative merits of short-term
tests. Thus, development of appropriate statistical techniques for the analysis of data
arising from short-term assays remains the primary goal of this project. In addition to
the development of statistical analyses, an increasing amount of attention has been
paid to: (i) methods for meaningful assay validation and (ii) the exploitation of large
databases for the assessment of interlaboratory and interassay concordance. In
response to the heightened interest in in vivo mechanisms of genetic toxicity, this
project has been broadened to include study of a number of in vivo tests. Efforts have
also been expended to explore those issues that are uniquely characteristic of genetic
toxicity studies of human subjects, an area of increasing research activity. (NLM)
Systematic Account and Critical Appraisal of Current Epidemiological Approaches
for Monitoring Reproductive Outcome in Industry
Carlo GL
Department of Epidemiology, Dow Chemical, Midland, MI
Prog Clin Biol Res: Vol. 160, 1984, pi39-45
(NLM)
The Teratogeoic Risk
Tuchmann Duplessis H
Faculte' de M'edecine, Laboratorie d'Embryologie, Paris, France
Prog Clin Biol Res: Vol 117, 1983, p245-58 (REF: 32)
Reproduction can be impaired in animals and man by drugs and various environmental
agents. Depending on the time of exposure—from fertilization through the fetal period
and eventually during lactation—the consequences can range from embryotoxicity,
gross malformations and a large variety of more subtle morphological, biochemical,
and functional abnormalities. The high susceptibility of the embryo to exogenous
agents is due to cellular multiplication and differentiation and to the lack of develop-
ment of the enzyme systems necessary for the detoxification of chemicals. At present,
developmental impairments represent the main cause of perinatal mortality and postna-
tal morbidity. After a review of prenatal physiology and teratogenic principles, the
action of selected drugs and environmental agents is analyzed. The potential danger of
environmental factors during intrauterine development is of particular concern be-
cause of its irreversible nature. (NLM)
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Tissue Doses in Man: Implications in Risk Assessment
Golkar SO
Dep. Radiobiol., Univ. Stockholm, Stockholm
Dev. Toxicol. Environ. Sci.: Vol 11, ISS Dev. Sci Pract. Toxicol,
1983, 289-98
CBAC COPYRIGHT: CHEM ABS The possibility of using binding to blood proteins,
esp. Hb, for the detection and in vivo dosimetry of genotoxic compds. was investigated.
The method utilized the high-resolving power of chem. anal, and could, because of its
applicability to animals and man, provide translation factors for risk estn. (NLM)
Toxicologic Effects of Air Pollution on Reproduction, Epidemiological Studies -
Literature Review
Nordstroem S; Forsberg B
Statens Vattenfallsverk, Vaellingby (Sweden). Projekt KOL-HAELSA-MILJOE
NTIS/DE83751429, U.S. Sales Only., 39p
TD3: Air pollutions include a number of toxic agents emitted from fossil fuels (NOsub
(x), SO sub 2, CO, POM heavy metals). Epidemiological studies of health effects from
such pollutions have been performed concerning lung cancer and cancer mortality, dis-
eases in the respiratory and circulatory systems, infant mortality and total
morbidity/mortality. Very few studies on reproductive hazards (except for effects
from tobacco smoke) have been presented in the literature. This is noticeable, as the
embryo or the fetus is more sensitive to toxic factors than children and adults. The
first trimester in utero, including the organogenesis, is the most sensitive period. Even
the last trimester of pregnancy is, however, a sensitive period, in that we have increas-
ing evidence that toxic agents may cross the placenta and affect the growing and
developing fetus. Epidemiological studies performed, suggest that in populations living
in polluted areas, there are effects on fertility, fetal mortality, and birth weights. In
Swedish studies decreased birth weights were found in polluted areas especially in
later pregnancies (>2). The significance of this pregnancy order effect is so far not
known. Thus, increased levels of air pollutions may involve increased risks of fertility
problems and fetal damage. Consequently, continuous risk evaluations and risk es-
timates should be imperative. (ERA citation 09:003408) In Swedish. (NLM)
Types of Exposure Models and Advantages and Disadvantages of Sources of
Exposure Data for Use in Occupational Reproductive Studies
Lemasters GK; Selevan SG
Department of Environmental Health, University of Cincinnati, OH
Proa Clin Biol Res: Vol. 160, 1984, p67-79 (REF:20)
(NLM)
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**Use of Animal Models for Detecting Specific Alterations in Reproduction
Amann RP
Animal Reproduction Laboratory, Colorado State University,
Fort Collins, CO
Fundam ADD! Toxicol: Vol 2, ISS 1, 1982, pi3-26 (REF: 59)
Conventional tests of reproductive toxicity may fail to detect the effects of some
agents altering reproductive functions in the male or female. A valid study of
reproductive toxicity must be based on a sound understanding of the underlying
reproductive physiology, use of sensitive and precise analytical methods, a powerful
experimental design, and evaluation of multiple criteria in both the male and female.
Potential sites and mechanisms of action of an agent affecting reproduction were con-
sidered together with approaches for tests that might be used. Development of new in
vitro tests, based on procedures used for probing reproductive physiology, would be
desirable. Procedures for detecting alterations in male reproductive function using
animal models were considered in detail. For example, spermatogenesis is a long
process and a toxic agent may alter functionality of a testicular cell-type several days
or weeks before this toxicity is detectable as a change in spermatogenesis is a long
process and a toxic agent may alter functionality of a testicular cell-type several days
or weeks before this toxicity is detectable as a change in spermatogenesis. Several
weeks or months may pass before a detectable change in semen occurs. Therefore, tests
utilizing appropriate animal models should have a duration that is six times the dura-
tion of one cycle of the seminiferous epithelium. Evaluations of male reproductive
function would be enhanced by including determinations of testicular spermatid
reserves, selected simple but precise and meaningful quantitative evaluations of tes-
ticular histology, determination of the number of sperm within the distal half of the
epididymis, evaluation of the progressive motility and morphology of sperm from the
distal end of the epididymis, and measurement of the concentration of follicle
stimulating hormone in blood. For rabbits, longitudinal analyses of seminal quality are
important. (NLM)
Use of Cytogenetic Endpoints in Human Lymphocytes as Indicators of
Exposure to Genotoxicants
Preston RJ
Oak Ridge National Lab., TN
Department of Energy, Washington, DC
NTIS/DE85001262, 22p
TD3 The utility of the lymphocyte assay for chemical is discussed, with reference to
the underlying mechanisms of induction of chromosome alterations. Possible ways of
increasing the sensitivity of the assay in order to make it more useful for population
monitoring are also discussed. (Refs. 28) (ERA citation 09:050630) Symposium on new
approaches in toxicity testing and their application to human risk assessment, St. Louis,
MO, 14 Sep 1983. (NLM)
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"Workshop Proceedings: Approaches for Improving the Assessment of
Human Genetic Risk—Human Biomonitoring
Fowle JR, III
Environmental Protection Agency, Washington, DC,
Office of Health and Environmental Assessment
Report No.: EPA/600/9-84/016, Aug 84,59p
Type document: Conference proceeding
NTIS No. PB85-103018/XAB
Federal laws require a consideration of adverse health effects, including mutagenicity,
in arriving at regulatory decisions on chemical substances. Certain laws require
balancing the consequences of these risks with the benefits provided by the use of
chemical substances. This requires that risk be quantitatively assessed. Estimates of
human genetic risk can be made indirectly based on data from animal experimentation
and human somatic cells, but it is not practical to estimate genetic risk directly based
on data from human germ cells. The indirect estimates are highly debated because of
uncertainties about interspecies and interorgan extrapolations. Uncertainties in ex-
trapolating from effects observed in animals at high experimental doses to effects
likely to occur in humans at much lower environmental levels further complicate
genetic risk assessment. Comparative studies are needed to define the relationships be-
tween somatic cell and germ cell events and between experimental animals and
humans. This may involve selecting at least one high risk human population for study.
These efforts will require a long-term coordination of efforts among the Federal
agencies and among government agencies, industrial concerns, and the academic
community.
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HEALTH RISKS
NEUROTOXICITY
Animal Models of Neurological Disease
Anderson SM
NINCDS, NIH
CRISP/86/NS02264-09
US Dept of Health and Human Services; Public Health Service;
National Inst. of Health, Natl. Inst. of Neuro. and Communicative
Disorders and Stroke
CRISP Data Base National Institutes of Health
(NLM)
"Behavioral Toxicology in Risk Assessment: Problems and Research Needs
Mitchell, CL; Tilson, HA
Laboratory of Behavioral and Neurological Toxicology,
National Institute of Environmental Health Sciences,
Research Triangle Park, NC
CRC Crit. Rev. Toxicol. V. 10:4, Oct 1982.98 265-274 p.
Behavioral methods are being used with increasing frequency in toxicology to assess
the deleterious effects of chemicals to which we are exposed. The impetus for the use
of behavioral techniques in risk assessment resulted from the presumption that they
were more sensitive than other tests in detecting toxicity. A more logical reason for
the use of behavioral tests is the fact that behavior is the functional indicator of the
net sensory, motor, and integrative processes occurring in the central and peripheral
nervous system. Thus, the functional capacity of the nervous system cannot be deter-
mined independent of behavioral analysis. Some of the problems confronting be-
havioral toxicology are (1) the translation of human subjective complaints into be-
havioral tests in animals; (2) determining subtle effects on the nervous system in the
face of the well-known functional reserve and adaptability of the system; (3) dealing
with the variety of statistical problems resulting from the use of multiple tests, mul-
tiple measurements using the same test and the (relatively) large variability inherent in
some behavioral phenomena; and (4) selecting the proper tests. Three critical research
needs in behavioral toxicology as they relate to risk assessment are (1) development
and validation of methods, (2) determining subpopulations at greatest risk, and (3)
developing a strategy for determining interactions between two or more agents. (DOE)
**A Computer-Administered Neurobehavioral Evaluation System for
Occupational and Environmental Epidemiology. Rationale, Methodology,
and Pilot Study Results
Baker EL; Letz R; Fidler A
Occupational Health Program, Harvard School of Public Health, Boston, MA
J Occup Med: Vol 27, ISS 3, 1985, p206-12
To facilitate the conduct of epidemiolgic studies of populations at risk for or suffering
from central nervous system (CNS) dysfunction due to environmental agents, a
computer-administered neurobehavioral evaluation system has been developed. The
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system includes a set of testing programs designed to run on a microcomputer and
questionnaires to facilitate interpretation of results. Standard tasks evaluating
memory, psychomotor function, verbal ability, visuospatial ability, and mood were
selected and adapted for computer presentation following the recommendation of an
expert committee of the World Health Organization and the National Institute for Oc-
cupational Safety and Health. In two pilot surveys, test performance was found to be
influenced by age, education level, and socioeconomic status in ways consistent with
prior research findings. Performance on tests of short-term memory and reaction time
was negatively correlated with intensity of organic solvent exposure among industrial
painters. In view of the ease of administration and data handling, high subject
acceptability, and sensitivity to the effects of known neurotoxic agents, computer-
based assessment of CNS function holds promise for future epidemiologic research.
(NLM)
Neurobehavioral Testing of Chemicals: Impact on Recommended Standards
Anger WK
National Institute for Occupational Safety and Health,
Division of Biomedical and Behavioral Science, Cincinnati, OH
Neurobehav Toxicol Teratol: Vol 6, ISS 2, 1984, p!47-53
Historically, the American Conference of Governmental Industrial Hygienists (ACGIH)
has served as a major source of information on recommended safe exposure limits
(Threshold Limit Values or TLV's) for chemicals most frequently encountered in U.S.
industry and of known toxicologic significance. A review of the ACGIH Documenta-
tion book, which details the basis for their judgements, has indicated that 167 of the
588 chemicals for which they assigned recommended standards have, as one of their
bases, direct nervous system effects. In order to increase the impact of future be-
havioral toxicology research on recommended standards, the neurotoxicologist can util-
ize certain strategies: (a) Focus on established mixtures in the environment of interest
or select exposures of particular chemical classes, considering population size and
severity of effect; (b) Ensure that the results of the study are referable to the expected
route of exposure in the environment of interest; and (c) Select tests with face validity
for non-psychologists, using reference substances. Finally, the neurotoxicologist is
urged to consider effects related to safety as well as health in developing his/her
research. (NLM)
Cross Species Extrapolation and Hazard Identification in Neurotoxicology
Dyer RS
Neurophysiology Branch, U.S. Environmental Protection Agency,
Research Triangle Park, NC
Neurobehav Toxicol Teratol; Vol 6, ISS 6, 1984, p409-ll
(NLM)
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Occupational Neuropathy—Mechanism, Detection, Treatment (Human, Animals)
Spencer PS
Albert Einstein College, Bronx, NY
CRISP/86/OH00851-06
US Dept of Health and Human Services; Public Health Service;
National Inst of Health, National Institute for Occupational Safety
and Health
CRISP Data Base National Institutes of Health
RPROJ/CRISP This is a combined experimental and clinical study of the occupational
neuropathy induced by repetitive overexposure to acrylamide monomer. The ex-
perimental portion (90% of workload) continues from previous studies which suggest
the neuropathic potency of acrylamide is linked to toxic inhibition of certain
glycolytic enzymes which are required for the maintenance of axonal transport and
nerve-fiber integrity. Proposed studies are designed to test this hypothesis. A tissue-
culture model of acrylamide neuropathy will be developed and used to study
acrylamideinduced degeneration of living nerve fibers in vitro. Selected drugs (e.g.,
substrates and inhibitors of glycolysis and Krebs cycle) will be tested for their ability
to modify the neurotoxic response to acrylamide in vitro. Agents which protect by
delaying or preventing the onset of nerve fiber degeneration in culture will be tested
for their effects on mice repeatedly treated with acrylamide. Initial studies will
employ dietary supplementation with sodium pyruvate, an effective therapeutic
regimen in rats treated with acrylamide. Treated and control animals will be assayed
for neuropathy by quantitative functional, morphological and biochemical assays. The
relationship between molecular and cellular mechanisms of acrylamide neurotoxicity
will be examined by determining the effects of single and multiple doses on energy-
dependent axonal transport. Dose dependent decrements in fast retrograde transport
will be examined in sensory and motor axons and their relationship to changes in fast
anterograde transport and distal axonal degeneration determined. The fate of vul-
nerable glycolytic enzymes transported slowly from neuronal perikaryon to nerve ter-
minal will be examined in the optic nerves of rabbits with advanced acrylamide
neuropathy. Finally, studies in rats will examine the current hypothesis that
acrylamide induces damages to axons by direct toxic action on nerve fibers. Rates of
binding of acrylamide to proteins in peripheral nerves will be determined with the aid
of radiolabeled toxin. The clinical portion (10% of workload) will explore the efficacy
of the newly developed Optecon Tactile Tester to monitor worker populations at risk
for acrylamide and related neuropathies. The major goals of these studies are to
develop experimentally proven methods to diagnose, prevent and treat individuals with
acrylamide and related occupational neuropathies. These studies respond to some of
the research needs specified in the National Institute of Occupational Safety and
Health Criterion Document for Acrylamide (1976). (NLM)
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ECOLOGICAL RISKS
"Aquatic Hazard Assessment: Concepts and Application
Kimerle, Richard A.
Monsanto Co, St. Louis
Presented at Intl Joint Comm Hazard Assessment Sym, Ann Arbor,
Apr 9-11, 79, p221(10)
Technical feature: Numerous approaches and procedures now exist for evaluating the
aquatic safety/hazard of chemicals. Some of these evaluation schemes are surveyed,
and their flaws and inconsistencies are identified. Needs in hazard assessment process
development are discussed. Applications of such techniques are also considered. (5
diagrams, 3 graphs, 4 references) (ENVL)
"Ecosystem Risk Analysis
O'Neill, RV et al.
Environmental Toxicology and Chemistry 1982
V. 1:167-177
"Effects of Pollutants at the Ecosystem Level
Sheehan, Patrick J.
International Council of Scientific Unions. Scientific Committee
on Problems of the Environment (SCOPE)
New York, Wiley, 1984
Type document: Series: SCOPE Report No. 22
EPA Libraries: EJE OTS; EKB RTP; EKC GBreeze; ELB Cine.;
ELD Duluth; ESB Corv.
Call Number: QH545.A1E33
'Estimating Hazard
Cairns, John Jr.
Virginia Polytechnic Institute, Blacksburg, VA
Bio Science 1980. V.30(2):101-107
"Estimating the Hazard of Chemical Substances to Aquatic Life
Carins, John; Dickson, Kenneth L.; Maki, Alan W.
Virginia Polytechnic Inst & State Univ.
Hvdrobiologia. Jun 1, 79, V64, N2, PI57(10)
Technical Report: The state of the art of assessing hazards from chemicals to aquatic
life is reviewed. Safety, hazard, and risk concepts involved in such assessments are
discussed. A conceptual framework for conducting a hazard assessment is presented.
93
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Various toxicity tests and procedures for evaluating hazards in aquatic life are
compared. Decision criteria used in these procedures are tabulated. Safety factors (i.e.,
uncertainty factors) are the basis for a sequential testing approach in which estimates
of expected chemical concentrations in the environment and of their effects can be
made with an increasing degree of accuracy and confidence. Further refinements of
hazard assessment procedures are needed. (1 graph, 6 references, 3 tables) (ENVL)
"'Evaluating Environmental Exposure Through Innovative Biological Tests
Eaton J; Anderson DR
Risk assessment in aquatic ecology; proceedings
Environmental Protection Agency, Duluth, MN
Envirotest, Seattle, WA
Feb 1986. 1.15-1.27 p
EPRI workshop on risk assessment in aquatic systems,
Albuquerque, NM 13 Apr 1983
Availability: Research Reports Center, Box 50490, Palo Alto, CA
Report No.: EPRI-EA-4438; CONF-8304100
Type document: Analytic of a Report; Conference literature Standardization of
aquatic toxicology test procedures, while useful in many regards, has tended to inhibit
development of innovative biological testing that could provide a better basis for
evaluating aquatic hazards posed by toxic agents. Reliance on the routine techniques
has fostered complacency among aquatic toxicologists and discouraged interdiscipli-
nary exchange of different types of relevant information. One of the ways hazard
evaluation could be improved is through the application of more fate information to
toxicity test design. Fate data describe the nature of the exposure of organisms to a
toxicant in the field. Indeed, it may not be appropriate in the case of most test
materials to do any biological testing until an adequate fate profile is available.
Development of such a profile requires the cooperation of chemists, biologists and
modelers to determine the important elements that should be included in each analysis
(i.e., to define adequate). In some cases sufficient data for profiles are already avail-
able that have not been utilized in selecting and designing tests. Fate profiles could be
quite general -- related to the major environmental characteristics of entire categories
of toxicants — or could be very specific. The important aspect is not in the develop-
ment of the fate profiles themselves, but in how they would drive development of new
or modified biological tests. One or more of several unique biological test conditions
might be incorporated into these test designs, their selection being based on field ex-
posure parameters. Several examples are described where knowledge or estimations of
fate have resulted in more relevant biological tests or in more appropriate hazard
evaluations. (DOE)
**Extrapolating from the Laboratory to the Field: How Uncertain Are You?
Suter, GW II, et al.
American Society for Testing and Materials
Aquatic Toxicology and Hazard Assessment: Seventh Symposium.
ASTM STP 854. 1985, 400-413 pp.
This paper describes some of the pitfalls associated with extrapolating laboratory data
to field conditions as revealed by the application of risk analysis methods to ecological
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effects of toxic materials. While hazard assessment is concerned with determining the
acceptability of particular concentrations or releases of toxicants, risk analysis at-
tempts to derermine the probability that a particular release will cause a particular
level of effect. For example, a risk analysis might attempt to determine the probabil-
ity that the routine effluents of a synfuels plant will cause a 25% reduction in the
biomass of commercial and game fish [1]. Thus risk analysis is concerned with what
we expect will happen and how likely we are to be wrong.
''Fundamentals of Aquatic Toxicology: Methods and Applications
Rand, Gary M; Petrocelli, Sam R
Washington, DC, Hemisphere Publishing Corp, 1985
EPA Libraries: EJE OTS; EKA R4; EKC GBreeze; ELB Cinn;
ELD Duluth; EGA R8
Call Number: QH90.57.B5F86
**Hazard Evaluation Division. Standard Evaluation Procedure.
Ecological Risk Assessment
Urban, Douglas J.; Cook, Norman J.
Washington, DC, EPA, June 1986
Type Document: Report
EPA Report No. EPA 54019-85-001
NTIS No. PB86-247657
State-of-the-art techniques for ecological risk assessment with procedures, philosophies,
and extrapolative techniques as used in the Ecological Effects Branch, Hazard Evalua-
tion Division, Office of Pesticide Programs, EPA. Risk assessment procedures are
described for pesticide uses proposed for registration under the Federal Insecticide,
Fungicide, and Rodenticide Act as amended, 7 U.S.C. 136 et seq.
EPA Libraries: EJB HQ
'Limitations of Laboratory Bioassays and the Need for Ecosystem Level Testing
Kimball KD; Levin SA
Bio Science. 1985. v.35(3):165-171
New Perspectives in Ecotoxicology
Levin, Simon A. (ed.)
Ecosystems Research Center, Cornell Univ., Ithaca, NY
ERC Report No. 14
Corporate Source: EPA, Office of Research and Development.
Cooperative Agreement No. CR807856 01.
Ithaca, NY, Ecosystems Research Center, 1982. 161 pp
Application of Ecosystem science to the regulation and
management of toxic substances
Keywords: Ecosystem Science and Regulation; Ecosystems Characteristics
and Processes; Methods for Ecotoxicology; Mathematical Models
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**On the Relevance of Microecosystems for Risk Assessment: Some
Considerations for Environmental Toxicology
Smies, Maarten
Shell IntI Petroleum Maatschappij Bv, Netherlands
Ecotoxicoloev & Env Safety. Aug 83, V7, N4, P355(ll)
The relevance of microecosystpm studies for environmental toxicology is evaluated,
with emphasis on environmental toxicity testing and risk assessment concerning chemi-
cal pollution. Microecosystems are any multispecies system with at least two trophic
levels and its abiotic surroundings enclosed by artificial boundaries for research
purposes. A standardized microecosystem design will probably not contribute to en-
vironmental hazard rating if it replaces currently used test schedules. (Numerous
references, 1 table) (ENVL)
**On the Use of Indices in Aquatic Toxicological Hazard Assessment
McErlean, Andrew J.; Duke, Thomas W.
Environmental Research Lab., Gulf Breeze, FL
Report No.: EPA-600/J-82-058; CONTRIB-432
Nov 81 13p
Pub. in Regulatory Toxicology and Pharmacology 1, p344-354 1981
Type Document: Journal article
PB82-239013
Application of environmental indexing techniques to aquatic toxicological hazard
assessment is illustrated using three common data types (factors): acute invertebrate
and vertebrate LC50 data and octanol-water partition coefficients for 37 chemical
compounds. Subindex factor rating scales are constructed, total index computation is
illustrated, and possible uses of this or other similar indices are discussed. (NTIS)
**A Perspective on Quantitative Structure-Activity Relationships in
Ecotoxicology. (Editorial)
Lipnick, Robert L.
EPA Office of Toxic Substances
Environmental Toxicology and Chemistry 1985, Vol. 4, p.255-257
EPA Libraries: EJE OTS; EKC GBreeze; ELB Cinn; EMB Ada; ESB Corv
"Principles of Ecotoxicology
Butler, GC
Scientific Committee on Problems of the Environment
New York, Wiley & Sons, 1978. 350 pp
Type document: Series: SCOPE Report No. 12
EPA Libraries: EJE OTS; EKB RTF; EKC GBreese; EKD Athens;
ELB Cinn; ENA R7; ERB Las Vegas; ESB Corv.
Call Number: QH545.A1P74
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"Prioritization of Chemicals According to the Degree of Hazard in the
Aquatic Environment
Branson, Dean R.
Dow Chemical Co, MI
Env Health Perspectives. Feb 80, V34, PI33(6)
Survey Report: A promising scientific approach for classifying priority pollutants in
the aquatic environment is presented. Under the hazard assessment approach, chemi-
cals with the proven least margin of safety are awarded the highest priority. The least
margin of safety is defined by the gap between the no-observable-effect concentration
and the ambient exposure concentration. A hazard assessment of PCB's, DI-2-
ethylhexyl phthalate, linear alkybenzene sulfonate, and pentachlorophenol is included.
(3 graphs, 15 references, 3 tables) (ENVL)
"Research Needs in Developing Structure Activity Relationships
Lipnick, Robert L.
EPA Office of Toxic Substances
In: Aquatic Toxicology and Hazard Assessment: Eighth
Symposium. ASTM STP 891, p78-82
Philadelphia, American Society for Testing and Materials, 1986
EPA Libraries: EJB HQ
**Research Plan for Ecological Risk Assessment [Draft]
Office of Research and Development
Office of Environmental Processes and Effects Research
June 27, 1986
CERI-86-21A
Appendix. Related Work (FY86) [Draft]
[Office of Research and Development]
June 27, 1986
CERI-86-21b
"Risk Assessment by Analysis of Extrapolation Error: Demonstration for
Effects of Pollutants on Fish
Suter GW II; Vaughan DS; Gardner RH
Oak Ridge National Laboratory, Oak Ridge, TN
Environmental Toxicology and Chemistry. 1983 v.2:369-378
This article describes a new method for risk assessment and applies it to assessing the
risk of chronic toxicity of mercury to largemouth bass. The method consists of ex-
trapolation between taxa and between toxicity test types by regression analysis. The
variance terms in the regression analyses are combined with the point estimate of the
geometric mean of the maximum allowable toxic concentration (GMATC) to derive a
probability distribution of the GMATC. This distribution is then compared to the am-
bient contaminant concentration to derive the probability or risk of chronic toxicity.
This general approach to risk analysis is applicable to any organism or toxicant.
97
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Testing for Effects of Chemicals on Ecosytems: Working Papers Prepared
as Background
(Final rept)
National Research Council, Washington, DC, 1981 260p
See also PB82-127200
PB83-132811
The eleven working papers in this volume were prepared for the study of the Com-
mittee to Review.Methods for Ecotoxicology. The charge to the Committee was to
identify characteristics of ecological systems that would indicate hazardous effects of
chemicals beyond the level of single species, to establish criteria for suitable testing
schemes, and to evaluate the effectiveness of available test systems in assessing effects
of chemicals within ecosystems. To assist in its deliberations on the broad range of
issues to be addressed, the Committee sought additional input from a number of
experts. The working papers address a variety of topics: the use of microcosms as a
testing scheme in terrestrial and aquatic systems; lethal gene distribution and diatoms
as monitoring techniques for hazard assessment in wetlands and watersheds; ap-
proaches to assessing the environmental impact of radionuclide and xenobiotic organic
substances; a general review of ecosystem properties relevant to ecotoxicology; and a
discussion of the advantages and disadvantages of various of ecological tests. (NTIS)
User's Manual for Ecological Risk Assessment
Barnthouse LW; Suter GW II (Eds.)
Oak Ridge National Laboratory, Oak Ridge, TN
Prepared for the EPA, Office of Research and Development
EPA contact: Mogkissi, AA; Kutz F
Environmental Sciences Division
Publication No. 2679, March 1986. 215 pp.
This report presents the results of a four-year project on environmental risk analysis of
synfuels technologies, funded by the Office of Research and Development (ORD), U.S.
Environmental Protection Agency. The overall objective of the project was to support
the ORD's synfuels research program by developing a risk assessment methodology
capable of (1) ranking the waste streams in a process by risk to the environment, (2) es-
timating the change in environmental risk that would be achieved using alternative
control technology options, (3) estimating the sensitivity of risk estimates to site-
dependent variables, and (4) identifying research problems contributing the greatest
uncertainty to risk estimates.
"Wildlife Toxicology
Kendall, Ronald J.
Western Washington Univ., Bellingham, WA
Environmental Science and Technology. 1982. v.!6(8): 448A-453A
"Integrated field and laboratory studies using selected model species might lead to
ways of quantifying adverse effects of chemical contaminants."
98
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CORPORATE RISK ASSESSMENT
"Comments of the Chemical Manufacturers Association on EPA's Proposed
Guidelines for Carcinogenic Risk Assessment
Submitted to EPA by the Chemical Manufacturers Association on
January 24, 1985 +
"Comments of the Chemical Manufacturers Association on EPA's Proposed
Guidelines for Exposure Assessments
Submitted to EPA by the Chemical Manufacturers Association on
January 22, 1985 +
**Comments of the Chemical Manufacturrs Association on EPA's Proposed
Guidelines for the Health Assessment of Suspect Developmental Toxicants
Submitted to EPA by the Chemical Manufacturers Association
on January 25, 1985 +
"Comments of the Chemical Manufacturers Association on the
EPA's Proposed Guidelines for the Health Risk Analysis of
Chemical Mixtures
Submitted to EPA by the Chemical Manufacturers Association
on March 11, 1985 +
"Comments of the Chemical Manufacturers Association on EPA's
Proposed Guidelines for Mutagenicity Risk Assessment
Submitted to EPA by the Chemical Manufacturers Association
on January 23, 1985 +
Risk Analysis in the Chemical Industry
Chemical Manufacturers Association
Rockville, MD: Government Institutes, Inc., 1985 pp.269
+ Other submissions from industry on the Risk Assessment Guidelines are filed at the
Public Information Reference Unit (202)382-5926 EPA Library, 401 M Street, S.W.,
Washington, D.C. 20460
99
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POLICY
"Determining Risks to Health: Federal Policy and Practice
Corporate Source: U.S. Dept. of Health and Human Services.
Task Force on Health Risk Assessment
Dover, MA, Auburn House, c. 1986
xxii, 410p, Illustraded. Includes Index, Bibliography
p. 325-331
Type Document: Book
Keywords: U.S. Government Agencies; Health Policy; Probability;
Research; Risk
ISBN:0-86569-138-X
ISBN:0-86569-139-8
EPA Libraries: EJB HQ
**Risk and the Government Process
Munro, I.C.; Morrison, A.B.; Bradshaw L.
Health & Welfare Canada, Ottawa Royal Society of
Canada/Et Al Risk Assessment & Perception Sym, Toronto,
Oct 18-19, 82, P183(8)
Conference Paper: Responsible regulatory decisions by governments regarding en-
vironmental hazards require careful evaluation of potential risks to humans. Animal
studies serve as a qualitative surrogate for human experience, but the quantification of
human risk on the basis of such data is questionable. In addition to risk assessment,
many other health, economic, and social factors must be considered by governments in
regulating environmental hazards. These include consumer expectations, impact on
trade, availability of less hazardous substitutes, feasibility and cost of consumer educa-
tion programs, and ability to enforce laws. (10 references) (ENVL)
**Risk Assessment and Regulatory Policy
Wilkinson CF
Cornell Univ., Institute for Comparative and Environmental Toxicology
Comments on Toxicology. 1986, Vol. 1(1):1-21
(REFS 21)
101
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"Risk Assessment in the Federal Government: Managing the Process
Corporate Source: National Research Council (U.S.)
Committee on the Institutional Means for Assessment of
Risks to Public Health
Washington, DC, National Academy Press, 1983
Type Document: Book
Keywords: Cancer Prevention; Decision Making; Health
Planning; Environmentally Induced Diseases
EPA Libraries: EKA R4.RC276.N38 1983; EJA R3 RC276.N38 1983;
EH A Rl; El A R2; EIC Edison; EJB HQ; EJE OTS; EKB RTF;
EKD Athens; ELA R5; ELB Cinn; ELC Ann Arbor; EMA R6;
EOA R8; EDB NEIC; ERA R9; ESA RIO; ESB Corvallis
Call Number: RA445.R57
**Risk Assessment in the Policy-Making Process:
Environmental health and safety protection (focuses on the
United States Environmental Protection Agency and Food and
Drug Administration; based on conference paper)
Regens, James L., et al.
Public Admin R 43:137-45 Mr/Ap '83
(PAIS)
**The Use of Risk Analysis in Federal Regulatory Agencies: An Exploration
Kraft, Michael E.
Univ of Wisconsin
Policy Studies Review. May 82, VI, N4, P666(10)
Technical Feature: The role that risk analysis can play in Federal decision-making is
examined. Ways in which risk analysis can be used by Federal Regulatory Agencies is
described. Its future role as a tool in health, safety, and environmental regulation is
analyzed. (16 references) (ENVL)
**Use of Risk Assessment in EPA Regional Operations
Atlanta, GA, EPA Region 4, 1985
Keywords: EPA; Health Risk Assessment
EPA Libraries: EJB HQ
Report No.: EPA 904/5-85-140
Call Number: EPAX8603-0022
102
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LEGAL ASPECTS
"Legal Considerations in Risk Assessment Under Federal Regulatory Statutes
Hutt, Peter Barton
In: Assessment and Management of Chemical Risks,
Chapter 6. Washington, DC, American Chemical Society 1984
Throughout history, regulatory statutes to protect the public health and safety have
been worded in sufficiently broad and general terms to authorize the government to
utilize current scientific knowledge in determining adequate public protection. The
statutory requirements of current health and safety laws implemented by FDA, EPA,
CPSC and OSHA are sufficiently flexible to allow the adoption of whatever analytical
and decision-making methodology best represents the public interest. Implementation
of current regulatory statutes in this field is therefore constrained largely by the cur-
rent state of scientific knowledge rather than by rigid or obsolete statutory
requirements.
EPA Libraries: EJB HQ
**Risk and Benefit in Environmental Law
Ricci, Paolo F; Molton, Lawrence S
(EPRI) and Science. Dec 4, 81, V214, N4525, P1096(5)
Technical feature: The treatment in law of several key issues in risk assessment is
discussed: The meaning of the 1980 ruling that OSHA must demonstrate that a stand-
ard is needed to remedy a significant risk, the burden of proof under consitions of
scientific uncertainty, and the resolution of the conflict between the need to reduce
hazardous exposures and the desire for accuracy. There exist under current regulatory
statutes several paradigms for balancing costs and benefits. (35 REFS) (ENVL)
**The Role of Courts in Risk Assessment
Jenkins, Bruce S
Environmental Law Reporter 16:Aug 86, 10187-95
103
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USES OF RISK ASSESSMENT
**EPA's Risk Assessment Process and Its Use in Making Risk Management Decisions
Patrick, DR
U.S. Environ. Prot. Agency, Research Triangle Park
Pro. - APCA Annu. Meet.; Vol 78th, ISS Vol. 3, 1985,
85-33.3, 8 pp.
CBAC Copyright: Chem Abs. Review; cancer risk assessment pollution; Air pollution
Cancer risk from, assessment of; Carcinogens In air and water, risk from, assessment
of; Public health Carcinogen exposure in air and water in relation to; Water pollution
Cancer risk from, assessment of. (NLM)
"Introduction to Risk Analysis [2nd edition]
Megill, RE
Tulsa, OK, Pen Well Pub. Co.
Keywords: Risk; Mathematical Models; Petroleum Industry
and Trade; Gas Industry
EPA Libraries: EKB RTF; ELA R5
Call Number: HB615.M43 1984
"Pesticide Hazard Assessment
Wayland, Robert H.
EPA Office of Toxic Substances, Wash DC
Presented at Intl Joint Comm Hazard Assessment Sym,
Ann Arbor, Apr 9-11, 79, P85(7)
Technical Feature: One of the most controversial and difficult EPA tasks is pesticide
regulation. Provisions of the Federal Insecticide, Fungicide, and Rodenticide Act of
1972 and other legislation affecting such regulation are examined. Validated hazard
informtion is combined with exposure potential to produce the EPA position on the
potential risk posed by pesticide use. (ENVL)
**Risk Assessment of Complex Mixtures
Gibb, H.J.; Chen, C.W.
Environmental Protection Agency, Washington, DC.
Office of Health and Environmental Assessment
Report No.: EPA-600/D-84-186
Jul 84 23p
PB84-223478
Quantitative carcinogenic assessment of complex mixtures is complicated by the
variability of the mixtures. Different samples of effluents from the same source may
vary in.their carcinogenic potency. A multiplicative effect could be produced by the
action of different fractions of a mixture on different stages of the carcinogenic
process. A mathematical formula explaining this multiplicative effect is presented
here. Antagonism may result from the action of different fractions on the same stage.
Actual data from both epidemiologic studies and animal investigations are used for
illustration. (NTIS)
105
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Risk Assessments for Energy Systems and Role of Preliminary
Degree-of-Hazard Evaluations
Habegger, L.J.; Fingleton, D.J.
Argonne National Lab., IL
Sponsor: Department of Energy, Washington, DC
Report No.: CONF-8511148-2
Nov 85 16p
Task force meeting on risk and policy analysis under conditions
of uncertainty, Laxenburg, Austria, 25 Nov 1985
Type Document: Conference Proceeding
Contract No.: W-31-109-ENG-38
DE86005564/XAB
The appropriate approach to risk or hazard assessment can vary considerably, depend-
ing on various factors, including the intended application of the results and the time
other resources available to conduct the assessment. This paper illustrates three types
of interrelated assessments. Although they can be mutually supportive, they have fun-
damentally different objectives, which require major differences in approach. The ex-
ample of the overall risk assessment of alternative major energy technologies illustrates
the compilation of a wide range of available risk data applicable to these systems.
However, major uncertainties exist in the assessments, and public perception of their
importance could play an important role in final system evaluations. A more narrowly
defined risk assessment, often focusing on an individual component of a larger system,
is the most commonly used approach in regulatory applications. The narrow scope al-
lows in-depth analysis of risks and associated uncertainties, but it may also contribute
to a loss of perspective on the magnitude of the assessed risk relative to that of the un-
assessed risks. In some applications, it is useful to conduct semiquantitative degree-of-
hazard evaluations as a means of setting priorities for detailed risk assessment. The
MAHAS procedure described in this paper provides a means of rapidly ranking rela-
tive using easily accessible data. However, these rankings should not be used as defini-
tive input for selecting technology alternatives or developing regulations. (25
references, 6 tables)
ERA citation 11:020040) (NTIS)
"Risk Assessments/Risk Management for Environmental Uses of Biological Agents
Anderson EL; Albert RE; Kamely D.
Environmental Protection Agency, Washington, DC.
Office of Health and Environmental Assessment
Sponsor: New York Univ. Medical Center, NY
Report No.: EPA/600/D-85/285
C1985 13p
Prepared in cooperation with New York Univ. Medical Center, NY
Pub. in Banbury Report 22; Genetically Altered Viruses and
the Environment, p27-38 1985
PB86-131810
Through recent advances in molecular biology, especially biotechnology, regulatory
agencies are faced with evaluating a range of biological agents for potential risks they
pose to human health and the environment. Although biological risks are of relatively
recent concern, this has not been the case for chemicals. Over the past several years,
the Environmental Protection Agency (EPA) has developed methodologies for assessing
106
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health risks associated with chemical pollutants, especially chemical carcinogens. In
anticipation of regulating biological agents, including genetically engineered
microorganisms, the Agency must stimulate the generation of a solid scientific basis in
order to adapt its present, chemically based risk assessment approaches to biological
agents. Assessing biological Uses of Risk Management risk poses unique problems
owing to the diversity (hormones, enzymes, bacteria, fungi, viruses, plasmids) and the
ability of live molecules to replicate, transform, transduce, and infect. (NTIS)
"Risks Associated with Nuclear Power: A Critical Review of the Literature,
Summary and Synthesis Chapter
National Academy of Sciences, Committee on Science and Public Policy
Washington, DC, National Academy of Sciences, 1979
Keywords: Nuclear Reactors; Safety Measures; Radiation Effects;
Radioactive Wastes
EPA Libraries: ERA R9
Call Number: TK9152.R5822
"Risks of Nuclear Power Reactors: A Review of the NRC Reactor Safety Study
Kendall, Henry Way; Hubbard, Richard B.; Minor, Gregory C.
Cambridge, MA, Union of Concerned Scientists, 1977
Type Document: Report
Keywords: Nuclear Regulatory Commission; Reactor Safety Study;
Safety Measures; Accidents
EPA Libraries: ERB Las Vegas
Call Number: WASH-1400
"Selected Approaches to Risk Assessment for Multiple Chemical Exposures
Stara JF; Erdreich LS
Environmental Protection Agency, Cincinnati, OH
Environmental Criteria and Assessment Office
Type Document: Conference Proceeding
Report No.: EPA/600/9-84/014B
Jun 84 162p
See also PB84-226992
PB84-227008
This appendix to Selected Approaches to Risk Assessment for Multiple Chemical
Mixtures: Progress Report on Guideline Development at ECAO-Cin' contains post-
meeting comments on the issues sent by the peer reviewers of the workshop, plus
selected references pertaining to the guidelines. All pertinent comments have been
addressed in the primary report. (NTIS)
107
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"Selected Approaches to Risk Assessment for Multiple Chemical Exposures:
Progress Report on Guideline Development at ECAO
(Environmental Criteria and Assessment Office)-Cincinnati
Stara JF; Erdreich LS
Environmental Protection Agency, Cincinnati, OH
Environmental Criteria and Assessment Office
Report No.: EPA/600/9-84/014A
Jun 84 117p
See also PB84-227008
Type Document: Conference Proceeding
PB84-226992
This report summarizes the second of a series of workshop meetings on methods for as-
sessing human health risks from exposure to chemical mixtures sponsored by the En-
vironmental Criteria and Assessment Office (ECAO) of the U.S. Environmental Protec-
tion Agency, July 12-13, 1983. The first workshop 'Approaches to Risk Assessment for
Multiple Chemical Exposures' held in September 1982 provided a basis for selecting
methods to develop into risk assessment guidelines. Five issues were reviewed at this
meeting: (1) inter-species conversion of dose and duration of exposure, (2) assessment
of risk for less than lifetime exposure to carcinogens and to other toxicants, (3) ad-
ditivity model for chemical mixtures, (4) methods for determination of acceptable
daily intakes from quantal of continuous data, and (5) pharmacokinetic basis of route-
to-route conversions. Working groups also produced recommendations for approaches to
four additional problems: consideration of high risk subgroups, assessment of multiple
routes of exposure, ranking the severity of effects and the use of exposure and
monitoring data in health risk assessment. A symposium on this methodology is
planned for the fall of 1984. (NTIS)
"The Use of Environmental Risk Analysis for Ranking Hazardous Substances
Released to Soil or Groundwater
McKone, Thomas E.
NRC
IES ENV Technology 29th Technical Sym, Los Angeles,
Apr 19-21, 83, P380(5)
Conference paper: An approach for indexing the long-term health risks of toxic
chemicals and radionuclides using crustal chemical cycles is detailed. The external en-
vironment is depicted in a pathways model, which uses a landscape prism as a tool for
mapping toxic material cycles on and near the crustal surface. Average concentrations
in air, water, and food are derived and translated into a collective population dose
field expressed as daily intake. The models are used to index the health risk added to
a hypothetical landscape from additions of arsenic, lead, uranium 238, and radium 226
to groundwater and soil. (2 diagrams, 13 references, 3 tables) (ENVL)
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Uses of Risk Assessment
Moore, John
US EPA Office of Pesticides and Toxic Substances
Washington, DC, EPA, 1985
Type Document: Conference Proceedings
Notes: Risk Assessment Conference, March 18, 1985
EPA Libraries: EJB HQ
Call Number: EPAX 8510-0007
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BIBLIOGRAPHIES AND OTHER SOURCES ....this section highlights a variety of
documents, including bibliographies, serial publications, directories, special subject
collections, indexes, etc. These sources lead to informtion and data on specific chemicals
and chemical groups as well as on many of the intricate components of risk
assessment including exposure, fate, toxicity, chemical safety and handling,
physical and chemical properties, standards and regulations, manufacturing and
use, etc.
"Air Toxics Information Clearinghouse: Bibliography of Health Effects
and Risk Assessment Information
(Interim rept.)
Pelland AS; Post BK; Mead RC
Radian Corp., Research Triangle Park, NC
Sponsor: Environmental Protection Agency,
Research Triangle Park, NC.
Office of Air Quality Planning and Standards
Report No.: RAD-84-240-016-52-05
23 Jul84 74p
Type Document: Bibliography
Contract No.: EPA-68-02-3513
PB86-181161/XAB
The document provides state and local air agencies and other Clearinghouse users with
citations to selected publications pertaining to health effects and risk assessment of
toxic pollutants. These documents were published by the following four agencies: Na-
tional Academy of Sciences, The World Health Organization, the National Cancer In-
stitute of Occupational Safety and Health of the Centers for Disease Control. In
selecting references for inclusion in the bibliography, emphasis was placed on docu-
ments published since 1974 which reported health effects of toxic or potentially toxic
pollutants that can be emitted into the air and assessments of risks of these pollutants.
Most documents focus on one or more toxic or potentially toxic chemicals, and a few
focus on exposure to toxic substances in a particular industry. While ambient air ex-
posure was the focus, references on occupational exposure and exposure via drinking
water were also included. Summaries and compilations emphasizing analyses of infor-
mation on pollutants rather than results of individual toxicity or health effects tests
were included to keep the bibliography a manageable size. (NTIS)
"EPA Publications Bibliography. Quarterly Abstract Bulletin
EPA, Office of Administration and Resource Management, Washington, DC
This quarterly publication has two cumulative volumes: EPA Cumulative
Bibliography, 1970-1976 and the EPA Cumulative Bibliography, 1977-1983
The subject section is useful for locating the Agency's risk assessments on specific
chemicals or environmental hazards. The reader also has access to the assessment litera-
ture by author, title, and contract number.
Available in all EPA Libraries
111
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"Hazardous Waste Collection and Hazardous Waste Database
Environmental Protection Agency
A specialized collection of journals, articles, commercial databases, books, EPA reports,
other related technical reports, and Office of Solid Waste and Emergency Response
Policy and Guidance directives. Each EPA Library has the index to the Collection in
hard copy, and PC format. Updates are added quarterly. For further information con-
tact the HQ Library at 8-382-5922.
"Information Resources in Toxicology
Wexler, Phillip
New York, Elsevier, 1982, 333 pp
This is a comprehensive guide with annotated references that surveys the literature as
well as national and intrnational organizations, and educational programs.
EPA Libraries: EJE OTS
Call Number: RA1193.4.W49
"The Office of Toxic Substances Information Architecture Notebook
EPA, Office of Toxic Substances, Springfield, VA
National Technical Information Service, Aug 1983
PB 84-188655
Chapters V and VII direct the reader to a variety of standard references for obtaining
information on chemical identification, health and ecological effects, exposure
assessment; chemical production, use, and volumes; regulation and standards.
EPA Libraries: EJB HQ; EJE OTS
**ORD Topical Directory
USEPA, Office of Research and Development
Washington, DC, EPA, February 1986
Type Document: Directory
An alphabetical listing of areas in which the Office of Research and Development
(ORD) has technical expertise, individuals who are active in these areas, with a
telephone number and office/laboratory location.
EPA Libraries: EJB HQ
EPA Report Number: EPA 600/9-86-006
Risk Assessment Bibliography [Draft]
Malin, Wayne
(Draft) EPA Region 1 Library, JFK Federal Building, Boston, MA
112
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"Risk Assessment Review
Cincinnati, OH, EPA CERI Distribution, EPA, Office of Research
and Development and Region IV Atlanta
Document Type: Serial
Frequency: Bimonthly
An in-house EPA publication intended to serve as a forum for
information exchange on risk assessment activities and developments.
Distributed by: EPA-Center for Environmental Research
Information/ORD. 26 West St. Clair St., Cincinnati, OH 45268
(513) 684-7391 (513) 569-7391
**Superfund Risk Assessment Information Directory
U.S. Environmental Protection Agency.
Office of Information Resources Management and
Office of Toxic Substances, Washington, D.C. 20460
Office of Solid Waste and Emergency Response
EPA 540/1-86/61 OSWER Directive 9285.6-1)
Contract No. 68-01-7090. November 1986
The Directory has been developed for use by a diverse audience, including EPA
regional staff, state Superfund program staff, federal and state remedial contractors,
and potentially responsible parties. Sufficient background information on the risk
assessment process and its general information requirements is provided so that the
directory can be easily used by individuals with varying degrees of risk assessment
experience.
**Risk Assessment Forum Series
U.S. Environmental Protection Agency
This series prexents scientific and technical evaluation and review of issues arising
from the EPA Risk Assessment process.
Note: The first publication in this series is:
Proliferative Hepatocellular Lesions of the Rat: Review and Future
Use in Risk Assessment
EPA 625/3-86/011. Feb 86
Contact: Dorothy E. Patton, 202/382-7315
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ENVIRONMENTAL PROTECTION AGENCY
INFORMATION SYSTEMS INVENTORY (ISI)
The EPA ISI is an exhaustive catalog of the Agency's computerized information
systems. The ISI was compiled to help coordinate information gathering activities,
facilitate cross-media data sharing across programs, and eliminate duplicate data col-
lections and systems development. Many of the 500 files/systems in the Inventory sup-
port risk assessments. Only a sampling of descriptions of these systems follows. They
represent some of the risk assessment information/sources EPA has developed on
pesticides, radiation exposure, toxicity of chemicals for estimating health and ecologi-
cal risks, and surface water monitoring.
The complete EPA Information Systems Inventory is available from the National
Technical Information Service (NTIS), ordering number PB87-131017. It is also avail-
able in hardcopy and microfiche, PB87-131009.
The ISI is also available on diskette for use on an IBM PC. The EPA HQ Library
and Regional Libraries can search the database for EPA staff.
Contact: HQ Library 8-382-5922 or your EPA Library (Appendix B)
Examples of information systems in the ISI which contain risk information are
described in the following pages.
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EPA INFORMATION SYSTEMS INVENTORY
DATABASE NAME: National Pesticide Hazard Assessment Program
CONTACT: Frank Davido
PHONE: (703) 557-0576, FTS 8-557-0576
ABSTRACT:
The former National Pesticide Hazard Assessment Program conducted surveys and
studies designed to obtain information on human exposure to pesticides, environmental
monitoring and health effects information.
SUBJECT COVERAGE (KEYWORDS):
Pesticide Exposure
Health and Environmental Effects
Monitoring
PRODUCER:
Office of Pesticide Programs
FILE COMPONENTS:
Study reports
UPDATE FREQUENCY:
Annually
NUMBER OF RECORDS IN FILE:
50 reports have been prepared. A list of Titles are available
from the contact
(ISI)
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EPA INFORMATION SYSTEMS INVENTORY
DATABASE NAME: Pesticide Document Management System - PDMS
CONTACT: John Carley
PHONE: (703) 557-3240, FTS 8-557-3240
ABSTRACT:
The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires every pes-
ticide manufacturer or producer to submit scientific data to EPA before a pesticide
product can be manufactured in the United States. These data are maintained in the
Pesticide Document Management System. Related information from the published
literature is also included.
SUBJECT COVERAGE (KEYWORDS):
Pesticide Effects on Health and the Environment
Chemical Use
PRODUCER:
Office of Pesticide Programs
SOURCES:
Submission of data by chemical industry prior to manufacturing
pesticide products in the United States under the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA)
UPDATE FREQUENCY:
Daily
(ISI)
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EPA INFORMATION SYSTEMS INVENTORY
DATABASE NAME: Pesticide Poisoning Reports and Statistics
CONTACT: Jerome Blondell
PHONE: (703) 557-0321, FTS 8-557-0'321
ABSTRACT:
Reports and statistics related to human pesticide accidents are accumulated from a
variety of sources. The principal data available include mortality statistics, hospital-
ized poisoning estimates, emergency room estimates, physician-treated occupational
cases from California, and case reports summarized by specific pesticide.
SUBJECT COVERAGE (KEYWORDS):
Human Population
Health Effects
PRODUCER:
Office of Pesticide Programs
SOURCES:
U.S. Consumer Product Safety Commission - National Electronic Injury Surveil
lance System (surveys sample of emergency rooms)
California Dept. of Food and Agriculture
Poison Control Center Database
UPDATE FREQUENCY:
Annually
(ISI)
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EPA INFORMATION SYSTEMS INVENTORY
DATABASE NAME: Pesticide Product Information System - PPIS
CONTACT: John Carley
PHONE: (703) 557-3240, FTS 8-557-3240
ABSTRACT:
The Pesticide Product Information System contains information concerning all pes-
ticide products registered in the United States. It includes registrant name and
address, chemical ingredients, toxicity category, brand name, etc.
SUBJECT COVERAGE (KEYWORDS):
Registered Pesticides
Ingredient
Product Labels
Use
Registrant
Brand Name
Pest
Site
Toxicity
PRODUCER:
Office of Pesticide Programs
SOURCES:
Pesticide Registration Requirements
UPDATE FREQUENCY:
Daily
(ISI)
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EPA INFORMATION SYSTEMS INVENTORY
DATABASE NAME: Atmospheric Dispersion of Radionuclides
CONTACT: Christopher Nelson
PHONE: 703-557-9380, FTS 8-557-9380
ABSTRACT:
AIRDOS-EPA is a model for estimating annual intakes and exposures from the atmos-
pheric release of radionuclides. The purpose of the program is to provide these quan-
tities as input to a companion program (DARTAB) to assess the individual or collective
doses and risks associated with chronic releases of radionuclides. Atmospheric
dispersion, wet and dry deposition, and food pathway models are included. Provision
is made for radionuclide chain ingrowth and decay as well as environmental removal
in the terrestrial portion of the model.
SUBJECT COVERAGE (KEYWORDS):
Model
Non-Point Source
Radiation Exposure
Health Effects
Airborne Radionuclides
PRODUCER:
Office of Radiation Programs
(ISI)
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EPA INFORMATION SYSTEMS INVENTORY
NAME: Cohort Analysis of Increased Risks of Deaths Model-CAIRD
CONTACT: .Neal S. Nelson
PHONE: (202) 475-9640, FTS 8-475-9640
ABSTRACT:
The CAIRO Model (Cohort Analysis of Increased Risks of Deaths) is used in risk
analysis. Incremental health effects produced in a cohort exposure to radiation are
calculated by using a life table method for either an absolute or a relative risk projec-
tion model. If desired, incremental health effects can be calculated for any risk for
which a rate, preferably an annual rate, of occurrence is available. Risks can also be
stripped from the cohort to estimate what removal of a specific risk would do for life
expectancy.
SUBJECT COVERAGE (KEYWORDS):
Model
Human Population
Health Effects
Risk Assessment
PRODUCER:
Office of Radiation Programs
FILE COMPONENTS:
FORTRAN - IV source program
SOURCES:
Unabridged life tables and age-specific mortality rates
from any source can be used in the program. Currently
1970 and 1980 US data from the National Center for
Health Statistics are employed.
UPDATE FREQUENCY:
As necessary - Last update August 1986
NUMBER OF RECORDS IN FILE:
Approximately 1,000
(ISI)
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EPA INFORMATION SYSTEMS INVENTORY
DATABASE NAME: Dose and Risk Assessment Tabulation - DARTAB
CONTACT: Christopher Nelson
PHONE: 703-557-7380, FTS 8-557-73'80
ABSTRACT:
Program is used to compute fatal cancers and genetic defects from radiological con-
centrations on the ground surface, air, and in water and vegetation. It is used in con-
junction with RADRISK information to provide risk assessment information for
AIRDOSE-EPA, and PRESTO-EPA.
SUBJECT COVERAGE (KEYWORDS):
Cancer
Radiation Genetics
Human Population
Dose
Radiation Exposure
PRODUCER:
Office of Radiation Programs
(ISI)
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EPA INFORMATION SYSTEMS INVENTORY
DATABASE NAME: A Low-Level Radioactive Waste Transport
and Risk Assessment Code - PRESTO-EPA
CONTACT:
PHONE: 703-557-8610, FTS 8-557-8610
ABSTRACT:
PRESTO-EPA is computerized model which calculates the health effects to an exposed
population from the radioactivity which escapes from a shallow land burial site or
through options from a deep geologic burial site. DARTAB is used as a subroutine to
calculate fatal cancers and genetic defects. RADRISK data is required to run the
model.
SUBJECT COVERAGE (KEYWORDS):
Model, Human Population, Health Effects
Ground Water
Surface Water
Drinking Water
Site Characteristics
Treatment/Disposal
Radioactive Waste, Land Burial
PRODUCER:
Office of Radiation Programs
(ISI)
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EPA INFORMATION SYSTEMS INVENTORY
DATABASE NAME: Maximum Individual Dose Model - MAXDOSE
CONTACT: Daniel Egan
PHONE: 703-557-8610, FTS 8-557-8610
ABSTRACT:
The MAXDOSE code calculates accidental releases from a nuclear waste repository.
Both geological and human events are modelled. Each event produces a given set of
dose rates at different times and distances. A second set of tables estimate con-
taminated areas and individual risk. Both leaching and dissolution remove waste from
the matrix into the accessible environment. The releases are used to calculate the dose
table.
SUBJECT COVERAGE (KEYWORDS):
Environmental Releases
Model
Nuclear Waste
Radiation
PRODUCER:
Office of Radiation Programs
(ISI)
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EPA INFORMATION SYSTEMS INVENTORY
DATABASE NAME: Radionuclide Dose Rate/Risk
CONTACT: . Christopher B. Nelson
PHONE: 703-557-9380, FTS 8-557-9380
ABSTRACT:
RADRISK is a model designed to estimate the health risk due to inhalation or inges-
tion of radionuclides for arbitrary periods. The end result of the system is a set of
values relating fatal cancers and genetically significant radiation doses to a unit intake
of radionuclides. The model is a greatly revised combination of two previously exist-
ing programs—INREM II and CAIRD. The health risk from external exposures is also
estimated by the CAIRD model using does rates from a separate model—DOSFACTER.
SUBJECT COVERAGE (KEYWORDS):
Model
Health Effects
Radiation Health Risks
PRODUCER:
Office of Radiation Programs
UPDATE FREQUENCY:
Semiannually
(ISI)
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EPA INFORMATION SYSTEMS INVENTORY
DATABASE NAME: WESPDOSE 2/REPRISK
High Level Radioactive Waste Risk Model Environmental
Pathways Analyses
CONTACT: Michael Smith
PHONE: (205) 272-3402, FTS 8-534-7615
ABSTRACT:
This computer code is used in Office of Radiation Programs in ORP's high level
radioactive waste analyses to calculate somatic and genetic risk information for use by
the ORP REPRISK computer code. WESPDOSE 2 and REPRISK are used together to
calculate somatic and genetic health effects per Curie release of user specified radio-
nuclides to the available environment for four release modes, which are: releases to a
river, releases to an ocean, releases to land surfaces and releases to air. These codes
trace the environmental transport of radionuclides released via each of these release
modes through the applicable water, air and terrestrial environmental transport path-
ways to man, calculates the external exposure and intake of radionuclides, and deter-
mines the resulting somatic and genetic risk to the exposed population.
SUBJECT COVERAGE (KEYWORDS):
Human Population, Genetic Risk, Fatal Cancer Risk
Surface Water
Soil
Environmental Transport
Risk
Atmospheric Radiation, Exposure
PRODUCER:
Office of Radiation Programs
SOURCES: WESPDOSE 2.For and REPRISK.For
AVAILABLE AT: WESPDOES 2 - EPA/EERF, 1890 Federal Drive,
Montgomery, AL 36109 FTS 534-7615
REPRISK - ORP, 401 M Street, SW,
Washington DC 20460
(ISI)
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EPA INFORMATION SYSTEMS INVENTORY
DATABASE NAME: Mixture and Systemic Toxicant Risk Model - MSRM
CONTACT: Richard Hertzberg
PHONE: (513) 569-7582, FTS 8-684-7582
ABSTRACT:
This system contains statistical methods and extrapolation models for using available
toxicological and epidemiological data in estimating human health risk from exposure
by any route. Methods and graphics programs are also being developed for testing the
risk models. Cancer risk models are included for completeness, but are developed
elsewhere. Non-cancer risk assessment models and estimation procedures treat response
rates and discrete response categories as endpoints for single chemicals and mixtures.
The methods include those in the Agency Risk Assessment Guidelines for comparison.
SUBJECT COVERAGE (KEYWORDS):
Model, Health Risk Measures,
Body Burden
Human Population
Health Effects
Exposure
Nonhuman population
Statistics, Graphics, Physiological Parameters
PRODUCER:
Office of Research and Development
UPDATE FREQUENCY:
Quarterly
(ISI)
128
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EPA INFORMATION SYSTEMS INVENTORY
DATABASE NAME: Studies on Toxicity Applicable to Risk Assessment-STARA
CONTACT: Richard Hertzberg
PHONE: (513) 569-7582, FTS 8-684-7582
ABSTRACT:
This system contains all available quantitative toxicological data on environmental
chemicals. Studies are screened for appropriateness for human health risk estimation.
Data files include one record per dose group in the original reported units of measure.
Related WYLBUR EXEC procedures allow generation of formatted tables of the
original data, tables of data in human equivalent (dose-duration) terms, and graphs of
severity vs. dose and duration in original or human equivalent units. The data files
currently cover all Agency priority pollutants (water quality and air lists).
SUBJECT COVERAGE (KEYWORDS):
Model
Dose-Response
Human Population
Health Effects
Nonhuman Population
Graphics
Physiological Parameters
PRODUCER:
Office of Research and Development
UPDATE FREQUENCY:
Annually
(ISI)
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EPA INFORMATION SYSTEMS INVENTORY
DATABASE NAME: Probabilistic Dilution Model - PDM
CONTACT: Karen Hammerstrom TS-798
PHONE: (202) 382-3896, FTS 8-382-3896
ABSTRACT:
The Probabilistic Dilution Model, originally developed by the Office of Water, allows
an estimation of the percent of time a given concentration level may be exceeded in
receiving streams. These estimates are based on the statistical distribution of daily
volume flows, which typically approximate a log normal distribution, and upon solu-
tion of a mass balance dilution equation. The Design and Development Branch and the
Exposure Assessment Branch have put together a Basic program that uses the probabil-
istic dilution methodology. The program contains averages of mean and low flows of
streams in the major river basins of the U.S., broken down by direct and indirect dis-
chargers and SIC (Standard Industry Classification) codes.
SUBJECT COVERAGE (KEYWORDS):
Model
Monitoring
Surface Water
Receiving Streams
PRODUCER:
Office of Toxic Substances
UPDATE FREQUENCY:
Daily
(ISI)
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EPA INFORMATION SYSTEMS INVENTORY
DATABASE NAME: TSCATS - Toxic Substances Control Act Test Submissions
CONTACT: Doug Sellers
PHONE: 202-382-2320, FTS 8-382-2320
ABSTRACT:
TSCATS is the catalog of test submissions received by OTS under various provisions of
TSCA. Each record includes the purpose of testing (observations sought), the test
organism(s) used, the route of administration, submitting company, and performing
laboratory and where available, a description of the nature of the pure, component of
a mixture). The title of the submissions is given as well as file identification data. All
data are from the public record.
SUBJECT COVERAGE (KEYWORDS):
Risk Assessment; Toxicity; Health Effects Testing,
Environmental Effects Testing
PRODUCER:
Office of Toxic Substances
FILE COMPONENTS:
Submissions under TSCA Section 8(d) health and safety studies; Section 8(e)
notice of substantial risk, Section 4 Testing, FYI (for your information).
SOURCES: Unpublished health and safety studies and test results
submitted to EPA by chemical manufacturers and processors under
the Toxic Substances Control Act (TSCA)
UPDATE FREQUENCY: Quarterly
BEGINNING DATE: 1985
NUMBER OF RECORDS IN FILE: 4,000 citations covering 2,000
unique chemical substances
AVAILABLE: Tapes from National Technical Information Service
Chemical Information System
(ISI)
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EPA INFORMATION SYSTEMS INVENTORY
DATABASE NAME: IRIS
Integrated Risk Information System
CONTACT: Steven Young
PHONE: (202) 382-5625, FTS 8-382-5625
ABSTRACT:
IRIS is an E-Mail based system containing EPA data on a chemical by chemical basis.
Data include, when available, oral reference doses, carcinogencity assessments, acute
health hazard data, and risk management summaries. Sources of data include ORD,
OPTS, OW, OAR, OSWER, and OPPE.
SUBJECT COVERAGE (KEYWORDS):
Environmental Effects; Health Effects;
Physical-Chemical Properties; Chemical;
Population, Human; Chemical Use;
Risk Assessment; Risk Management
PRODUCER:
Office of Research and Development
(ISI)
132
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RISK
MANAGEMENT
DESCRIBES REGULATORY DECISION-MAKING PROCESSES TO
CONTROL AND MANAGE RISK.
General Perspective 135
Policy . 153
Legal Aspects 161
Health Risks 165
Economic Analysis 169
Corporate Risk Management 171
Bibliographies and Other Sources 173
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RISK MANAGEMENT
GENERAL PERSPECTIVE .... includes decision-making, acceptable risk, risk-taking
(psychology), multi-media approach, cross-media (holistic) approach, applications,
uncertainty, risk/benefit.
"Acceptable Risk
Fischhoff, Baruch
New York, Cambridge University Press, 1981
Type Document: Book
EPA Libraries: EHA Rl; EKE RTP OAQPS; ERA R9; ELA R5 [1983];
ESA RIO [1983]
Call Number: HD61.A24
"'Acceptable Risks
Imperato, Paaxl James; Mitchell, Greg
New York, Viking, 1985
Type Document: Book
Keywords: Preventive Medicine, Safety Education, Health
EPA Libraries: EMA R6; ESA RIO
Call Number: RA431.I46 1985
Air: A Significant Component of a Multi-Media Approach to the
Management of Hazardous Materials
Ford, John P.
Williams & Jensen, Washington, DC
Conference Title: Proceedings of the Third Annual Hazardous
Materials Management Conference. (Held as part of the
Hazardous Materials Management Conference & Exhibition.)
Philadelphia, PA, 1985 Jun 4-6
Source: Proceedings of the Annual Hazardous Materials
Management Conference 3rd. Publ by Tower Conference Management
Co., Wheaton, IL, p 5-10
E.I. Conference No.: 07549
Keywords: *Hazardous Materials—*Management; Air Pollution—Legislation; Risk
Studies—Assessment; Chemicals—Toxicity; Air Toxics; Priority Pollutants More is
known now about the nature and extent of air toxics than ever before. The General
Accounting Office has studied it. EPA has studied it. State and territorial air pollu-
tion program administrators have studied it, as well as others. In spite of these efforts,
inadequacies in the art of risk assessment and risk management assure that future
legislative and administrative initiatives will be the products of imprecise and incom-
plete data. Air toxics are increasingly seen as but one component of a complex multi-
media problem. Thus, Congress and administrative agencies are increasingly inclined
to go across media (and therefore bureaucratic program) lines. Proposed changes to the
Toxic Substances Control Act (TSCA), right to know proposals, CERCLA, and the
recent amendments to RCRA are illustrated. (El)
135
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Application of Risk Assessment and Risk Management
Ford, K
Ecol. and Environ., Denver, CO
National Environmental Health Association 49th Annual
Educational Conference, Las Vegas, NV, 23-27 June 1985
National Environmental Health Association, Denver, CO.
(CPI)
An Approach to Societal Risk Acceptance Criteria and Risk
Management
Okrent, David; Whipple, Chris
California Univ., Los Angeles, School of Engineering and
Applied Science.
Sponsor: National Science Foundation, Washington, D.C.
Research Applied to National Needs.
Report No.: UCLA-ENG-7746; NSF/RA-770166
Jun 77 380p
See also PB-261 866.
Contract No.: NSF-DEP75-20318
PB-271 264/4
A quantitative approach to risk acceptance criteria and risk management is proposed
for activities involving risk to individuals not receiving direct benefits, such as
employment, from the activity. Societal activities are divided into major facilities or
technologies, all or part of which are categorized as essential, beneficial, or peripheral,
and a decreasing level of acceptable risk to the most exposed individual is proposed
(say, 0.0002/year for essential, 0.00001/year for beneficial, and 0.000002/year for
peripheral activity). The risk would be assessed at a high confidence level (say, 90%),
thereby providing an incentive to the gaining of better knowledge. Each risk-
producing facility, technology, etc., would have to undergo assessment both of risk to
the individual and to society. The cost of the latter would have to be internalized,
probably via a tax paid to the Federal Government, which in turn would redistribute
the benefit as national health insurance or reduced taxes to the individual. Risk aver-
sion to large events would be built into the internalization of the cost of risk. (NTIS)
Approaches to Acceptable Risk: A Critical Guide
Fischhoff, Baruch; Lichtenstein, Sarah; Slovic, Paul;
Keeney, Ralph; Derby, Stephen
Oak Ridge National Lab., TN
Sponsor: Nuclear Regulatory Commission, Washington, DC;
Department of Energy, Washington, DC
Report No.: ORNLSUB-7656/1
Dec 80 336p
Prepared in cooperation with Decision Research, Eugene, OR,
Woodward-Clyde Consultants, San Francisco, CA, and Stanford Univ., CA
Contract No.: W-7405-ENG-26
NUREG/CR-1614
Acceptable-risk decisions are an essential step in the management of technological
hazards. The absence of an adequate decision-making methodology is neither good for
136
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hazard management nor good for society. This report offers a critical analysis of the
viability of various approaches as guides to acceptable-risk decisions. It does so by (1)
Defining acceptable-risk decisions and examining some frequently proposed, but
inappropriate, solutions. (2) Characterizing the essential features of acceptable-risk
problems that make their resolution so difficult. (3) Creating a taxonomy of decision-
making methods, identified by how they attempt to address the features of acceptable-
risk problems. (4) Specifying the objectives that an approach should satisfy in order to
guide social policy. (5) Rating the success of the approaches in meeting these
objectives. (NTIS)
"Chemical Safety: An Agenda for Continued Progress in the Control
of Toxic Pollutants
Illinois Env Protection Agency Report Env/84-001, Feb 84 (219)
State/Local Govt report a toxics control strategy for Illinois seeks to eliminate un-
reasonable risk of adverse effects on human health and the environment from exposure
to toxic pollutants. The agenda includes biological toxicity assessments, Site-specific
problem evaluations, risk management techniques, phased implementation, and in-
tegrated management. Guidelines are developed for controlling hazardous wastes on
land and in water, as well as for pesticides and air pollution control. (ENVL)
Cognitive Behavior and Information Processing Under Conditions
of Uncertainty
Jacobs, TO
Army Research Inst. for the Behavioral and Social Sciences,
Alexandria, VA, 15 Jul 83 5p
This article is from 'Management of Risk Uncertainty Workshop Held at Fort Belvoir,
Virginia on 13-15 July 1983.' AD-A136 230 p!65-169
AD-P002 310/1
Over the past decade, research and synthesis of findings on decision making have led
to the unequivocal conclusion that earlier conceptualizations about the decision process
were either overly simplistic or lacking in veridicality. The nature of the decision task
and the conditions under which it is performed have a profound influence on the deci-
sion process. These effects include the decision maker's view of the process, and
(probably) information processing strategies which the decision maker may be unaware
of having chosen. Further, there is a growing body of literature which suggests that
the nature of the decision process is strongly influenced by the organizational level at
which the decision maker is located, i.e., what his critical functions in the organization
are, and the nature of the cognitive skills he therefore must bring to the task. The
purpose of the present paper is to present some of these data, together with some pos-
sible implications they have for decision making under conditions of uncertainty, and
for risk management. (NTIS)
137
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Comparative Evaluation of Quantitative Decision-Making Approaches
(Final rept.)
Merkhofer, MW
SRI International, Menlo Park, CA
Sponsor: National Science Foundation, Washington, DC
Report No.: NSF/PRA-83014
Apr 83 165p
See also PB83-214106
Contract No.: NSF-PRA80-07238; SRI-2102
PB83-214114
Research undertaken to support the selection of a quantitative decision-making ap-
proach to a risk management problem is described. Risk is defined, and the character
of risks and the processes by which risks are generated are examined. The role of
government in risk management is addressed and arguments in favor of government
regulation are offered. A taxonomy is proposed for characterizing risk problems and
examples are supplied for each of the characteristics. Alternative decision-making ap-
proaches are suggested for supporting government decisions involving risk. Criticisms
directed at formal decision-making approaches are considered. Various decision-
making approaches are evaluated. (NTIS)
Comparative Evaluation of Quantitative Decision-Making Approaches.
Executive Summary
Merkhofer, MW
SRI International, Menlo Park, CA
Sponsor: National Science Foundation, Washington, DC
Report No.: NSF/PRA-83015 Apr 83 lOp
See also PB83-214114
Contract No.: NSF-PRA80-07238; SRI-2102
PB83-214106
The nature of the social risk management problem is explored and possible solutions to
the problem are offered. The question of whether or not the government should regu-
late in the face of increasing public concern over technological risks is addressed. It is
determined that government could act to modify the hazard, the process by which in-
dividuals are exposed to the hazard, the process by which exposure produces adverse
effects, or the valuation of those effects. The court's role in risk management is
addressed. Various decision-making approaches are compared, including applied social
welfare theory, decision-maker cost-benefit analysis, and 'supre decision-maker deci-
sion analysis. All of the approaches discussed are said to derive their perspective and
underlying logic from one or more of the following three distinct theories of decision-
making: cost-benefit theory, decision theory, and social choice theory. These theories
are defined and concerns and criticisms are expressed over the effectiveness and ap-
propriateness of decision-making approaches. (NTIS)
138
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"Dealing with Risk: The Planning, Management, and Acceptability
of Technological Risk
Griffiths, Richard F.
New York, Wiley, 1981
Type of Document: Book
Keywords: Industrial Safety; Risk Management
EPA Libraries: EJB HQ
Call Number: HD7261.D4
Development of Quantitative Risk Acceptance Criteria
Griesmeyer, JM; Okrent, D
California Univ., Los Angeles. Dept. of Chemical, Nuclear,
and Thermal Engineering
Sponsor: Department of Energy, Washington, DC
Jan 81 54p
Contract No.: AS04-78ET35400
ALO-130
Some of the major considerations for effective management of risk are discussed, with
particular emphasis on risks due to nuclear power plant operations. Although there are
impacts associated with the rest of the fuel cycle, they are not addressed here. Several
previously published proposals for quantitative risk criteria are reviewed. They range
from a simple acceptance criterion on individual risk of death to a quantitative risk
management framework. The final section discussed some of the problems in the es-
tablishment of a framework for the quantitative management of risk. (NTIS)
**Energy Risk Management
Goodman, GT; Rowe, WD
Corporate Source: Vetenskapsakademiens Internationella
Institut Fhor Energi Och Humanekologi. Beijerinstitutet, Sweden
New York, Academic Press, 1979
Type Document: Conference Proceeding
Keywords: Energy Facilities; Safety Measures; Environmental
Aspects; Risk Management
EPA Libraries: EJB HW; ELB Cinn.
Call Number: TJ163.15.E54
Environmental Protection Agency's Regulatory Practices: The Impact
of a Holistic Approach
Anzenberger, Lynn
Lafayette Coll, Dep of Chemical Engineering, Easton, PA
Environmental Progress: v 4 n 3 Aug 1985 p 155-160
Type Document: Journal article
The purposes of this report were to describe the separation of responsibility for the
current environmental regulations and some of the regulatory problems this creates.
As one possible solution to these regulatory problems, an integrated or 'holistic' ap-
139
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proach to regulation was investigated, paying specific attention to cross media
concerns. EPA's current efforts in addressing this issue was described and recommen-
dations for further action were presented. (10 REF.) (COMP)
"Environmental Risk Assessment
Chandler, Jerry LR
U.S. Food and Drug Administration, Center for Drugs and Biologies
BioEssavs. 1986, Vol 5(4): 176-180
"Environmental Risk Assessment
Whyte, Anne VT; Burton, Ian
Corporate Source: Scientific Committee on Problems of the
Environment (SCOPE)
Chichester, England, J. Wiley, 1980.
Type Document: Series: SCOPE Report 15
Keywords: Environmental Impact Analysis; Pollution, Risk
Management; Environmental Health
EPA Libraries: EJB HQ; EHA Rl, EJE OTS; EKB RTF;
EKD Athens; ELB Cinn.
Call Number: TD 194.6 E65
"Environmental Risk Management (Editorial)
Abelson, PH
Science: Vol. 226, ISS 4678, 1984, P1023
General Concept of Risk: Risk in Perspective
Whyte, Anne
Univ of Toronto, Ont. Can
Proceedings of the 28th Ontario Industrial Waste Conference
Toronto, Ontario, Canada, 1981 Jun 14-17, p3-36
Sponsor: Ont Minist of the Environ, Can
E.I. Conference No.: 00811
(El)
"Guide to Personal Risk Taking
Byrd, Richard E.
New York, AMACOM, 1974
Keywords: Risk; Middle Managers
EPA Libraries: ELB CINC; EOA R8
Call Number: HD61.B95
140
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Group Influence on Individual Risk Taking
Wallach, Michael A.
Journel of Abnormal and Social Psychology. 1962, Vol. 65,
No. 2, 75-86
EPA Libraries: EJB HQ
"Ideology and Environmental Risk Management
Miller, Alan
Univ. of New Brunswick, Canada
Environmentalist. Spring 85, V5, Nl, P21(10)
Journal article: The influence of ideology, a concept that has both psychological and
political implications, on an individual's approach to environmental risk is explored.
Environmental ideologies play an important role in environmental decisions; they are
held in place by sociopolitical and psychological factors. The technocratic mode not
only dominates the current scene but may do so for the foreseeable future. An ex-
tended and integrated form of environmental risk management requires a greater role
for the non-dominant ideologies. (1 diagram, 3 photos, 33 references, 3 tables) (ENVL)
An Introduction to Risk Management
Crockford, Neil
Dover, NH, Woodheed-Faulkner Pubs. Ltd., 1984
Type Document: Book
ISBN: 0-85941-116-8
"Learning to Manage Risk
Russell, Milton
Research Management xxix (4) JuI-Aug 86
Dealing successfully with technological risk will require overcoming the strong resis-
tance to risk management. Industry can do much to help.
"Managing Risk Perceptions
Fischhoff, Baruch, Univ of Oregon
Issues in Science and Technology. Fall 85, V2
Journal article: The continuing public debate over nuclear power offers proof of the
public's determination to have a say in the management of hazardous new technologies.
The public's perception of risks is an important element in the development of public
policies of risk management. The tendency of people to simplify issues, to ignore
evidence that contradicts their current beliefs, and to base their perceptions of relative
risk on what they see in the news media are observed. Some strategies are recom-
mended that risk managers might pursue when dealing with the public about risk
controversies. (ENVL)
141
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Measuring and Managing Environmental Risk
Douglas, JR
Electric Power Research Institute Journal 10:6-13, Jul/Aug 85
Illustrated
Source: Applied Service and Technology Index 1985
Methods in Risk Management - a Working Paper
Uppuluri, VRR
Oak Ridge National Lab., TN
Sponsor: Department of Energy, Washington, DC.
Report No.: CONF-8410171-5 1984 8p
US/Japan workshop on tritium radiobiology and health physics.
Tokyo, Japan, 29 Oct 1984
Contract No.: ACO5-840R21400
DE85008360/XAB
The methods in Risk Analysis to determine the health and environmental effects of
hazards to individuals and society are evolving in this rapidly developing field. In this
paper, we briefly discuss the current distinctions between Risk Assessment and Risk
Management, and discuss some methodological issues. We conclude this paper with a
method useful for prioritization in connection with the environmental, health, and
safety deficiencies at a number of sites. (9 references) (NTIS)
**Of Acceptable Risk: Science and the Determination of Safety
Lowrence, William W.
Los Altos, CA, W. Kaufman 1976
Keywords: Risk Management; Product Safety; Industrial Safety
EPA Libraries: EHA Rl; EJB HQ; ELA R5; ESA RIO; EHB Narrag;
EJE OTS: ELD Duluth; EIA R2; EKB RTF; ERB Las Vegas
Call Number: TS175.L68
**On the Use of Confidence Levels in Risk Management
Kastenberg WE; Solomon KA
Mechanical, Aerospace and Nuclear Eng., Sch. Eng. Applied
Sci., Univ. Calif., Los Angeles, CA 90024
J Hazard Mater 10(2-3). 1985. 263-278
A framework for incorporating uncertainty in risk management is developed and ap-
plied to two aspects of decision making: meeting standards or safety goals, and cost-
benefit criteria. The framework is applied to several case studies including toxic
chemicals in water, failure of civil engineering structures and nuclear power plants.
The framework proposes that decisions be based on a level of confidence, in addition
to comparing best estimate or point values with standards and goals. (NLM)
142
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"Perspectives on Benefit-Risk Decision Making
A Report of a Colloquium Conducted by the Committee
on Public Engineering Policy
Corporate Source: National Academy of Engineering. Committee
on Public Engineering Policy
Washington, DC, National Academy of Engineering, 1972
Type Document: Report
Keywords: Decision-making; Risk-taking (Psychology)
EPA Libraries: ENA R7; EGA R8; EJE OTS Doc NAS-125
Call Number: HD69.D4N3
"Principles for Use of De Minimis Concepts in Risk Regulation
Executive Summary
Corporate Source: National Science Foundation, Division of
Policy Research and Analysis
Arthur D. Little 1984
Type Document: Report
Keywords: Risk Management
EPA Libraries: EJE OTS
Call Number: Doc NS-50
**Risk Analysis and Scientific Method: Methodological and Ethical
Problems with Evaluating Societal Hazards
Shrader-Frechette, KS
Boston, D. Reidel, c. 1985
Type Document: Book
Keywords: Technology Assessment, Decision Making, Risk
EPA Libraries: EKE OAQPS - RTP
Call Number: T174.5 S48
**Risk Analysis in the Private Sector
Proceedings of the Society for Risk Analysis. Volume 3
Whipple, Chris, Electric Power Research Institute;
Covello, Vincent T, National Science Foundation (eds.)
Corporate Source: Society for Risk Analysis
New York, Plenum Press, 1986
516 p., illustrated 0-306-41924-6
Type Document: Series: Society for Risk Analysis. Vol. 3
Keywords: Chemical Risk Management, Occupational Risk Analysis,
Ethics and Values in Risk Analysis, Risk Analysis
and Risk Management: Issues, Methods, and Case Studies
Source of Abstract: Publisher
There has been a gradual shift of emphasis in risk analyses—from studies conducted in
support of federal regulatory decision-making to private sector analyses aimed at
preventing or reducing potential adverse environmental or health effects. This volume
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focuses on risk analysis in the private sector, gathering contributions from such fields
as toxicology, chemistry, biology, and many others.
EPA Libraries: EJB HQ
"Risk and Decision Making: Perspectives and Research
Raiffa, Howard
Corporate Source: National Research Council.
Committee on Risk and Decision Making
Washington, DC, National Academy Press, 1982
Type of Document: Book
Keywords: Risk-taking (psychology); Decision-making;
Technology Assessment
EPA Libraries: EJB HQ; EJE OTS; EJB HQ Ref
Call Number: HD61.R54 1982
"Risk Assessment and Management: Framework for Decision Making
Environmental Protection Agency, Washington, DC. Office of
the Administrator.
Report No.: EPA/600/9-85/002
Dec 84 38p
PB85-170157/XAB
The risk assessment and risk management initiatives described in this report are tools
which will help make possible more efficient protection of the environment and human
health. The authors expect to gain the following specific management advantages:
Risk assessment and risk management help set priorities. There are thousands of
chemicals in commerce and an unknown number of contaminants and unintended by-
products. Some of these could be important as pollutants, and as such, are proper tar-
gets for regulation if they pose significant risks to health or the environment. The
authors do not have the budget, nor will we ever have the time, to test each chemical
exhaustively. Screening by estimates of potential risk reduction is an attractive basis
for comparing regulatory priorities. They can use risk analytic methods to help sort
problems in terms of the likelihood that the Agency can do something constructive and
effective to improve public health and the environment. Risk management provides a
context for balanced analysis and decision-making. Toxic chemicals are legitimately
frightening: they can and do cause cancer and other diseases. The trouble is that we
are exposed to a complex, highly dilute mixture of chemicals, taken in through air,
water, and food. When disease strikes, cause and effect are seldom clearly linked. The
Agency can contribute to rational discussion by exposing the scientific basis for the
risk, including the confidence they have in the estimate; placing the risk reduction ex-
pected from the regulation in context with other risks and other opportunities for risk
reduction; and explaining the values on which the balancing judgments have been
made. Risk assessment and management produce more efficient and consistent risk
reduction policies. EPA's patchwork of authorities for controlling pollution needs to
be woven together more coherently, beginning at the analytical level and continuing
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through to the regulatory decision. Some important differences - defined by statute -
in the ways the laws manage risk will always remain, but a risk management approach
can use their remaining administrative flexibility to make more efficient use of the
Agency's and society's resources to reduce risk and to make the Agency's actions more
consistent. (NTIS)
*Risk Assessment and Risk Management
Journal of Hazardous Materials 10: 163-454, Jul 85
Bibliography; Maps; Diagram
"Risk Assessment and Risk Management
Cheney, David W., US Congressional Research Service
Env Education Report. Apr 85, V13, N4, P21(7)
Journal Article: One approach to improve the regulation of risks is to improve the
quality of scientific information used in making regulatory decisions. The role of in-
formation in risk regulation is explored, as are options to improve the quality of this
information. A distinction is made between risk management and risk assessment.
Risk management can be enhanced by: improving the science upon which assessments
are based; developing guidelines for performing assessments; establishing procedures
for peer review of risk assessments; and centralizing risk assessment in each agency or
throughout all agencies. (ENVL)
**Risk Assessment and Risk Management
Solomon, KA (ed)
J. Hazard. Mater. 1985; 10(2-3) 293pp
CBAC COPYRIGHT: CHEM ABS Book; risk hazardous material Safety risk hazardous
material book; Chemicals Risk assessment and management in relation to Hazardous;
Handling of materials of hazardous substances, risk assessment and management in
relation to; Safety of hazardous materials, risk assessment and management in relation
to; Waste* Risk assessment and management in relation to Hazardous. (NLM)
Risk Assessment and Risk Management Decision-making for Chemical Exposure
Morgan MG
Dep. Eng. Public Policy, Carnegie-Mellon Univ., Pittsburgh
Environ. Exposure Chem. Vol 2, 1985, 107-43
CBAC COPYRIGHT: CHEM ABS Review chem exposure risk assessment; Health
hazard from exposure to chem., risk assessment and management in relation to; Process
simulation of exposure to chem. and effects, in risk assessment and management
Biological. (NLM)
145
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"Risk Assessment/Risk Management
Barber, Walter C.; Faden, Ruth; Ruckelshaus, William D.;
Nisbet, Ian C.
Chemical Waste Management, IL
Env Forum Sep 84, V3, N5, P17(16)
Journal srticle: EPA Administrator William Ruckelshaus has emphasized an evolving
role for risk analysis in the separation of risk assessment from risk management.
Scientific processes would be applied to assessing risk, and political processes would be
invoked in managing it. Opposing and supporting views concerning this philosophy are
expressed. (11 photos.) (ENVL)
"Risk Assessment Techniques: A Handbook for Program Management Personnel
Corporate Source: Fort Belvoir, Defense Systems Management
College
Washington, D.C., Government Printing Office; 1983
Type Document: Book
Keywords: Handbooks; Risk Management
EPA Libraries: EHA Rl 01A0003895; EJA R3
Call Number: UA23.985 1983
"Risk Assessments/Risk Management for Environmental Uses of
Biological Agents
Anderson EL; Albert RE; Kamely D
Environmental Protection Agency, Washington, DC. Office
of Health and Environmental Assessment
Sponsor: New York Univ. Medical Center, NY
Report No.: EPA/600/D-85/285 1985 13p
Prepared in cooperation with New York Univ. Medical Center, NY
Pub. in Banbury Report 22: Genetically Altered Viruses
and the Environment, p27-38 1985
Type Document: Journal article
PB86-131810
Through recent advances in molecular biology, especially biotechnology, regulatory
agencies are faced with evaluating a range of biological agents for potential risks
they pose to human health and the environment. Although biological risks are of
relatively recent concern, this has not been the case for chemicals. Over the past
several years, the Environmental Protection Agency (EPA) has developed
methodologies for assessing health risks associated with chemical pollutants, especially
chemical carcinogens. In anticipation of regulating biological agents, including geneti-
cally engineered microorganisms, the Agency must stimulate the generation of a solid
scientific basis in order to adapt its present, chemically based risk assessment ap-
proaches to biological agents.
146
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"Risk/Benef it Analysis
Crouch Edmund AC; Wilson Richard
Cambridge, Mass., Bellinger Pub. Co., 1981
Type Document: Book
Keywords: Risk-Evaluation; Risk Management
EPA Libraries: EJB HQ; EJE OTS; EKB RTP; ELB Cinn;
ELC Ann Arbor; ERA R9
Call Number: HD61.C77
"Risk/Benefit Analysis in Water Resources Planning and Management.
Proceedings held at the Asilomar Conference Grounds,
Pacific Grove, CA, September 21-26, 1980
Haines, Yacov Y
Corporate Source: Engineering Foundation Conference on Risk/Benefit
Analysis in Water Resources Planning and Management.
Universities Council on Water Resources
New York, Plenum, 1981
Type Document: Conference Proceedings
Keywords: Water Resources Development—Congresses;
Risk—Congresses; Decision Making—Congresses; Technology
Assessment—Congresses
EPA Libraries: ELB Cinn; ESA RIO
Call Number: TC401.E53 1980
"Risk-Benefit Analysis for Industrial and Social Needs
Moll, Kendall D., Stanford Research Institute;
Thansky, Dennis P., George Washington University
American Industrial Hygiene Association Journal. V.38,
Apr 1977, p.153-192
This study develops a decision method for evaluating the social acceptability of in-
dustrial controls on hazardous materials. Decisions are based on a "multiple criteria
approach" that jointly considers measures such as risk-benefit tradeoff, minimum
reducible health risk, maximum acceptable cost and implicit value of human life.
Health risks are calculated by combining separate estimates of production and usage
patterns, emissions to air and water, effectiveness of controls, pollutant dispersion and
human susceptibility. Economic benefits consider employment, trade and consumer
impacts, as well as direct costs of controls. The analysis focuses on asbestos as an ex-
ample hazard. Relative values of hazard reduction alternatives are examined for as-
bestos manufacturing exhaust filters and for asbestos substitutes in brake linings.
Preliminary calculations indicate risk reductions of these alternatives cannot justify
their social costs.
EPA Libraries: EJB HQ
147
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"Risk, Choice, and Prediction: An Introduction to Experimentation
Youden, William John
North Scituate, Mass., Duxbury Press, [1974]
Type Document: Book
Keywords: Probabilities
EPA Libraries: ELB Cin.
Call Number: QA273.15.Y68 1974
"Risk Evaluation and Management
Covello, Vincent T.; Menkes, Joshua; Mumpower, Jeryl (eds)
National Science Foundation
New York, Plenum, 1986
Approx. 725 pp., illustrated 0-306-41978-5
Type Document: Series: Contemporary Issues in Risk Analysis,
Volume 1
Keywords: Society and Behavior, Risk Perception, Risk Analysis
Methods, Risk Management Strategies
Source of Abstract: Publisher
Social and behavioral perspectives are becoming increasingly important in dealing with
the complex problems of risk management. The inaugural volume of this new series
explores many of the issues involved in the behavioral and social study of risk. The
distinguished panel of contributors, representing a diverse range of fields including
decision science and philosophy, focus on risk perception, risk analysis methods, and
risk management strategies.
EPA Libraries EJB HQ
"Risk Management and EiA: Research Needs and Opportunities
Grima AP; Timmerman P; Fowle CD; Byer P
Institute for Environmental Studies, University of Toronto
Hull, Quebec, Canada, Canadian Environmental Assessment
Research Council, 1986
Type Document: Background Paper
Keywords: Risk; Uncertainty; Public Perception of Risk;
Risk Evaluation; Indicators of Risk Mitigation; Economic Risk
ISBN 0-662-14775-8
EPA Libraries: EJB HQ
Risk Management Guide
Briscoe GJ
EG and G Idaho, Inc., Idaho Falls
Sponsor: Department of Energy, Washington, DC
Report No.: DOE/SSDQ£76-45/ll-REV.l; SSDC-11-REV.l
Sep 82 226 p
Contract No.: AC07-761D01570
DE84000492
The role of risk assessment is to provide the necessary information to make decisions
regarding the cost effective commitment of resources to accident prevention and
reduction. Risk assessment can also be used to determine if a proposed action is accept-
148
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able in those situations where it is impractical to eliminate particular hazards. A
limitation in this process is that estimates of future losses are necessarily based on
probabilities, statistics, and even subjective judgment; and therefore can never be
precise. The decision to allocate resources, thus, is always made in the face of
uncertainty. The purpose of risk analysis is to reduce that uncertainty as much as prac-
tical by providing a framework for the incorporation of all available information
regarding the costs and risks of various alternatives. This guide provides some
methods for analyzing and presenting this data to management.
(ERA citation 09.001362) (NTIS)
Risk Management in a Multi-Objective Decision-Making
Haimes YY
Case Inst. of Tech., Cleveland, OH
15 Jul 83 5p
This article is from 'Management of Risk and Uncertainty in Systems Acquisition:
Proceedings of the 1983 Defense Risk and Uncertainty Workshop
Held at Fort Belvoir, Virginia on 13-15 July 1983,
AD-A136 230, p217-221.
AD-P002-317/6
The thesis of this paper is grounded on the premise that the analysis of risk and uncer-
tainty — and ultimately the management of risk -- can be meaningful and effective
only when considered as an integral part of the decision-making process. Five major
elements or steps that encompass the risk assessment process — risk identification, risk
quantification, risk evaluation, risk acceptance and risk management — are discussed.
The risk assessment is shown to ultimately lend itself to a mult-objective decision-
making process. The surrogate worth trade-off method (a multi-objective optimization
method) and four risk assessment methodologies -- the multi-objective statistical
method, the partitioned multi-objective risk method, the risk/dispersion index method
and the uncertainty/sensitivity index method are briefly discussed. (Author) (NTIS)
"Risk Management of Existing Chemicals
Proceedings of a Seminar Conducted December 8-9, 1983,
Washington, DC
Corporate Source: Chemical Manufacturers Association
Rockville, MD; Government Institutes, Inc., 1984
Type Document: Conference Proceedings
Keywords: Chemicals—Manufacture and Industry—Toxicology;
Industrial Toxicology; Risk Management
EPA Libraries: EJB HQ; EHB Narragansett; EKE RTF OAQPS
RA1229.C517; ELB Cinn RA1199.R567 1984
Call Number: HD9650.C52
'Risking: How to Take Chances and Win
Viscott, David S
New York, Simon and Schuster, 1977
Type Document: Book
Keywords: Risk-taking (Psychology)
EPA Libraries: ELB Cinn
Call Number: BF6I1.V57
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Role of Liability Preferences in Societal Technology Choices: Results
of a Pilot Study
Cantor R; Rayner S; Braid B
Oak Ridge National Lab., TN
Sponsor: Department of Energy, Washington, DC.
Report No.: CONF-8510223-1 1985 150
Annual meeting of the Society for Risk Analysis,
Alexandria, VA, 6 Oct 1985.
Type Document: Conference Proceedings
Contract No.: AC05-840R21400
DE86003274/XAB
At the 1983 Annual Meeting of the Society for Risk Analysis, Steve Rayner presented a
paper that challenged the conventional wisdom of risk management research. In that
paper, he argued that resolving the question, "How safe is safe enough," is less impor-
tant in making societal technology choices than "How fair is safe enough." Adopting
the fairness question as the concern of risk management would imply that the process
of technology choice explicitly recognize the preferred principles different parties
hold with respect to obtaining consent from those affected by the risks, distributing
the liabilities, and justifying trust in the relevant institutions. This paper discusses a
recent empirical pilot study which explored the fairness hypothesis in the context of
nuclear power. Individual interviews and focus groups were conducted to examine
whether or not preferred principles for liability distributions were consistent with
those suggested by the cultural characteristics of the constituency. The results suggest
that for this type of societal technology choice, violation of these preferred principles
may be a major source of the conflict between different constituencies. Additionally,
the study contributes towards the development of a new approach in risk management
that combines the cultural model of risk perceptions with the decision-theoretic ap-
proaches found in economics and psychology. (NTIS)
"The Roles of Information, Discussion, and Consensus in Croup Risk Taking
Wallach, Michael A.; Kogan, Nathan
Journal of Experimental Social Psychology. 1: 1-19, 1965
EPA Libraries: EJB HQ
"The Scope of Environmental Risk Management
O'Riordan, Timothy
Univ of East Anglia, UK
Ambio (1979). V8, N6, P260 (5)
Feature Article: The concept of environmental risk management encompasses three
elements: cost-benefit analysis, environmental impact analysis, and risk assessment.
Because environmental risk management couples scientific analyses to political
judgments, too few decision-making institutions are adequately equipped to handle
delicate and potentially divisive combinations. There must be continuity between
political matters and scientific methods. (3 Diagrams, 17 References) (ENVL)
150
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Uncertainty Analysis for Engineers
Uhl VW; Lowthian WE
New York, American Institute of Chemical Engineers, 1982
Type document: Series: AlChe Symposium Series: No. 220
Keywords: Engineering, Risk Management, System Analysis
EPA Libraries: ELB Cinn.
Call Number: TA190.U53 1982
Use of Environmental Health-Risk Analysis for Managing Toxic Substances
McKone, Thomas E
Lawrence Livermore Natl Lab, Livermore, CA
Conference Title: Proceedings - 78th APCA Annual Meeting
Detroit, MI, June 16-21 1985
Sponsor: APCA, Pittsburgh, PA
Source: Proceedings, Annual Meeting - Air Pollution Control
Association 78 v 3, Publ by APCA, Pittsburgh, PA, Pap 85-33.
5, 16p 1985
E.I. Conference No.: 07333
Keywords: *Environmental Protection; Hazardous
Materials-Toxicity; Health Care; Mathematical Models;
Environmental Health Risk Analysis; Toxic Substance
Management; Compartment Models; Decay Constants; Intermedia
Transfer Coefficients; Human Exposure and Cancer Risk
The process of environmental health-risk analysis using a multi-media model is
developed in three phases. In the first phase, the concept of using compartment models
for modelling chemical fate is described. The second phase involves the development
of decay constants and inter-media transfer coefficients for use in the GENOTOX
model, which is a cross-media model used in the analysis. In the third phase, environ-
mental concentrations are linked to human exposures and cancer risk using an ex-
posure model that accounts for intake via seven pathways: inhalation; ingestion of
drinking water; fruits and vegetables; milk, meat and dairy products; fish; and soil;
and dermal absorption. Following the development of the models, there is an applica-
tions section in which the models are applied to tritium, arsenic and TCDD. (21 REFS)
(El)
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POLICY .... includes federal, state and local policy, science, public and regulatory policy.
Alternative Risk Management Policies for State and Local Governments
(Final rept.)
Okrent, David
California Univ., Los Angeles. School of Engineering and
Applied Science.
Sponsor: National Science Foundation, Washington, DC
Report No.: UCLA-ENG-8240;. NSF/PRA-&2020
Jun 82 173p
Contract No.: NSF-PRA79-10804
PB83-128983
A study of risk management at the state and local levels is described and some
proposals for improvement are considered. Risk management is distinguished from in-
surance management in that it is unconcerned with fault in the legal sense and tries to
anticipate losses to life and health as a means of devising corrective strategies. Two
case studies, one of seismically substandard buildings in Los Angeles and one involving
risks from drinking water, are presented. A wide variation in risk management is
shown to exist among states and within states and, at the local level, the variation is
shown to be even greater. It is found that quantitative grasp of risk seldom exists in
state and local government. (NTIS)
**Application of the NSF/PRA (National Science Foundation/Policy Research
and Analysis) Risk Analysis Program Results to Risk Management/Safety
Policy Formulation
(Final rept.)
Okrent D; Kastenberg WE; Apostolakis GE; Okrent ND; Szabo J
California Univ., Los Angeles. School of Engineering and
Applied Science
Sponsor: National Science Foundation, Washington, DC., Div.
of Policy Research and Analysis
Report No.: UCLA-ENG-8432; NSF/PRA-84029
Dec 84 347p
See also PB86-107364. Sponsored by National Science
Foundation, Washington, DC., Div. of Policy Research and
Analysis
Contract No.: NSF-PRA83-05097
PB86-107356/XAB
The text discusses the application of a range of research results on risk analysis to six
sets of risk management situations: (1) asbestos in schools; (2) hazardous chemical
waste sites; (3) indoor air pollution; (4) transportation of hazardous materials; (5) car-
cinogens and mutagens in drinking water; and (6) an industry employing bulk quan-
tities of a hazardous material such as dioxin. Recommendations for achieving in-
creased use of NSF/PRA sponsored studies by risk managers are included. (NTIS)
EPA Libraries: EJB HQ
153
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Application of the NSF/PRA (National Science Foundation/Policy Research
and Analysis) Risk Analysis Program Results to Risk
Management/Safety Policy Formulation. Executive Summary
Okrent, D.; Kastenberg, E.W.; Apostolakis, G.E.
California Univ., Los Angeles. School of Engineering and
Applied Science.
Sponsor: National Science Foundation, Washington, DC., Div.
of Policy Research and Analysis.
Report No.: UCLA-ENG-8432(ES): NSF/PRA-84026 Dec 84 21p
See also PB86-107356. Sponsored by National Science
Foundation, Washington, DC., Div. of Policy Research and
Analysis
Contract No.: NSF-PRA83-05097
PB86-107364/XAB
The summary addresses the application of research results emanating from the
NSF/PRA Risk Analysis Program to six risk management situations: (1) asbestos in
schools; (2) hazardous chemical wastes; (3) indoor air pollution; (4) transportation of
hazardous materials; (5) carcinogens and mutagens in drinking water; and (6) an in-
dustry employing bulk quantities of a hazardous material like dioxin. A structured
approach to the application of decision analysis is provided, alternatives to regulation
are identified and described, and some insight as to how the public should perceive
risk is offered. The need for further consideration of the problem of indoor radon is
highlighted and recommendations for achieving increased use of NSF/PRA sponsored
studies by risk managers are included. (NTIS)
"Classification of Risks (Alternative Risk Management Policies for State
and Local Governments)
Solomon, Kenneth A.; Meyer, Marshall W.; Szabo, Jacob;
Nelson, Pamela
California Univ., Los Angeles. School of Engineering and
Applied Science.
Sponsor: National Science Foundation, Washington, DC.
Report No.: UCLA-ENG-8245; NSF/PRA-82024 May 82 64p
Contract No.: NSF-PRA79-10804
PB83-129007
Societal risk management is defined and the hazards to which society might be exposed
are noted. Nine alternative taxonomies are suggested which categorize risk by the
situation in which the risk is encountered, by the cause of the risk, by the risk itself,
by the manner in which the risk is perceived, by the magnitude of the risk, by the
geographic division of risk management, by the dollars expended to manage the risk,
by the ratio of dollar damage to dollar benefit, and by the management of the risk.
The role of local government in risk management is examined. (NTIS)
EPA Libraries: EJB EPA Libraries EJB HQ
154
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Determining Risks to Health: Federal Policy and Practice
U.S. Department of Health and Human Services. Task Force
on Health Risk Assessment. 41 Op
Dover, MA, Auburn House Publishing Co., 1986
This book is based on a 1985 report to the Secretary of the Department of Health and
Human Services, by an intramural task force instructed to review the department's ac-
tivities in health risk assessment and management. The report is in the book
appendix... The official report presents a balanced and lucid summary of the
philosophy of risk, the methods of measurement, the problems in dealing with the un-
certainties in measurement, and the major issues of risk management. Recommenda-
tions are made for closer coordination of governmental activities, review of the peer-
review systems to ensure more public participation, more training in risk management,
and increased research in general toxicology, epidemiology, and research, which would
improve the methodology in the estimation and projection of risk...
"Environmental Protection: Laying the Foundation for the Year 2000
Russell, Milton
Environmental Forum: 4:7-12 F '86, chart
EPA's risk management approach; based on address
(PAIS)
Federal Activities in Risk Assessment and Risk Management in Biotechnology
Bulkley, BH
Off. Sci. and Technol. Policy, White House, Washington, DC
1985 AAAS Annual Meeting 8520021 Los Angeles, CA,
26-31 May 1985
American Association for the Advancement of Science (AAAS)
Washington, DC
(CPI)
**Food and Drug Administration: A Plan for Action
Food and Drug Administration, Rockville, MD. Executive
Secretariat
Report No.: FDA/ES-86/9
Jul 85 71p
PB86-107117/XAB
FDA's Plan for Action designates FDA's highest priorities and charts a broad course
for the Agency's policy and management directions in the years ahead. The plan was
based on extensive meetings that the Commissioner had with persons both inside and
outside of government. This action plan consists of the following: (1) New Drug
Review Process - specifically accelerate and improve review of human drugs; (2)
Medical Devices Program - implement the 1976 Medical Device Amendment to
facilitate marketing products; (3) Postmarketing Surveillance - strengthen activities to
enhance protection against new and unforeseen risks with marketed products; (4) Risk
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Assessment - evaluate, test and assess the risk to humans of compounds in the food
supply causing cancer in laboratory animals; (5) Risk Management - improve risk
taking process by prudent use of education, enforcement, regulation and voluntary
compliance; (6) Food Safety - resolve food safety issues by administrative and legisla-
tive means; (7) Nutrition - broaden program to advance nutrition science, increase con-
sumer awareness and assurance of quality of food supply; (8) New Technologies -
develop specialized capabilities in medical developments, food supply changes,
biotechnology and microelectronics; (9) Health Fraud - reduce health hazard and
fraud by increasing enforcement activities and professional and consumer awareness;
(10) Internal Management - improve Agency by career advancement, information
systems, laboratory research, resource allocation and science base. (NTIS)
EPA Libraries: EJB EPA Libraries: EJB HQ
"Improving the Use of Risk Assessment in Regulation
Rodricks, Joseph V
Environ, Washington, D.C.
Comments on Toxicology. 1986. Vol 1(1): 65-75
(8 REFS)
**The Management and Assessment of Risk from Recombinant Organisms
Fisher, E.
Journal of Hazardous Materials July 1985, Vol. 10, Nos. 2+3,
special issue, p. 241-261. (58 ref.)
Description of the "untraditional" path followed to develop risk management policies
for recombinant DNA research in the U.S.A. Aspects covered: the recombinant DNA
technique; potential risks; historical and institutions involved in rulemaking; the Na-
tional Institutes of Health (NIH) guidelines; risk assessment. (NLM)
**Office of Science and Technology Policy. Coordinated Framework for
Regulation of Biotechnology
Federal Register. v.51(123)/June 26, 1986: 23302-23350
Problems of State and Local Risk Management: An Overview
(Alternative Risk Management Policies for State and Local
Governments)
Bordas, William
California Univ., Los Angeles. School of Engineering and
Applied Science.
Sponsor: National Science Foundation, Washington, DC.
Report No.: UCLA-ENG-8246; NSF/PRA-82026 May 82 30p
Contract No.: NSF-PRA79-10804
PB83-128991
State and local risk management is defined as a four-part process characterized by risk
identification, risk assessment, risk acceptance, and risk monitoring and intervention.
Significant differences are found to exist in the comprehensiveness of risk manage-
ment policies between both state and local agencies and among state agencies. In a
156
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large state such as California, agencies demonstrate a significant capacity to engage in
comprehensive decision making. They identify new sources of risk, assess their efforts
and set standards of risk acceptance. In smaller states, more selective risk management
is evident due to resource constraints. Risk management policy at the state and local
levels is evaluated according to the decision strategies that are employed. (NTIS)
Protecting the Reproductive Health of Workers: Problems in
Science and Public Policy
Valentine JM; Plough Al
Boston University
J Health Polit Policy Law: Vol 8, ISS 1, 1983, p!44-63
This paper first reviews the scientific problems involved in assessing the effects on
reproductive health of toxic substances in the work environment. It then describes the
current status of regulatory policies designed to control workers' exposures to toxins
believed to affect reproduction. Finally, the paper discusses the relationship between
scientific uncertainty and regulatory strategies. Because demonstrating reproductive
health effects is extremely difficult, the assessment of the health risks of exposures, as
well as of the economic costs of regulation, is probabilistic. Therefore, uncertainty is
inherent in any regulatory decision in this area. And the case of reproductive risks is
illustrative of the more general problem of protectiong the health of workers within a
context of scientific uncertainty, and within a highly charged political environment
characterized by anti-regulatory sentiment and industries in economic decline. (NLM)
"Reducing Risk?
Stanf ield, Rochelle L.
National Journal (1986). 18(33-34): 2032
The Reagan Administration's frontal assault on environmental regulations did not
work five years ago, so now it's preparing an attack from the rear.
"Regulatory Program of the United States Government
U.S. Executive Office of the President; Office of
Management and Budget
Washington, DC, The Offices, 1985
Keywords: Administrations Regulations; Delegated Legislation
Notes: Issued each April 1 to cover the following 12 months
EPA Libraries: EJE OTS; ESA RIO
Call Number: KF70.2 A2U58
**The Revisionist: William D. Ruckelshaus
Mosher, Lawrence
Amicus J Spring 84, V5, N4 P32 (6)
Journal article: In his second tenure as EPA Administrator, William D. Ruckelshaus
seeks to revamp how the entire federal bureaucracy deals with the assessment and
management of environmental risks. Uniformity in toxic substance regulation must be
157
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attained amongst diverse federal agencies. Regulatory bodies must more distinctly dis-
tinguish their risk-assessment from their risk-management functions. Risk assessment,
rather than management, concepts and techniques will be pursued by EPA in protect-
ing public health. (2 drawings, 1 photo) (ENVL)
Risk Analysis and the Interface of Science, Law, and Policy
Middlekauff, RD
Food Technology 38:97-102
Bibliography
Source: Applied Science and Technology Index 1985
"Risk Analysis, Institutions, and Public Policy
Madden, Susan G
Port Washington, NY; Associated Faculty Press, 1984
Type Document: Series: Policy Studies Organization
Series Publication
Keywords: Risk Management — Addresses, Essays, Lectures;
Risk -- Government Policy ~ U.S. — Essays, Lectures
EPA Libraries: EHA Rl
Call Number: HD61.R56 1984
"Risk and Trust: The Role of the Regulatory Agencies
McGarity, Thomas O.
Environmental Law Reporter 16: Aug 86, 10198-204
Risk Assessment, Acceptability and Management
Proceedings of a seminar: report/prepared by the
Congressional Research Service, Library of Congress; for
the Subcommittee on Science, Research, and Technology;
transmitted to the Committee on Science and Technology,
U.S. House of Representatives, 97th Congress, first session,
November 1981.
Corporate Source: United States Congress, House, Committee
on Science and Technology, Subcommittee on Science, Research
and Technology, Library of Congress, Congressional Research
Service
Washington: U.S. G.P.O., 1981. vii, 116p ; 24 cm.
Keywords: Risk management-United States
(GPO)
158
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Risk Assessment Criteria for Risk Management at EPA
Goldstein, BD
EPA, Washington, DC
2nd Annual National Preventive Medicine Meeting —
Prevention '85 8510202, Atlanta, GA 28-31 Mar 1985
Association of Teachers of Preventive Medicine,
American College of Preventive Medicine Prevention '85,
Washington DC
(CPI)
**Risk Assessment in the Federal Government: Managing the
Process
National Research Council (US). Committee on the
Institutional Means for Assessment of Risks to Public
Health
Washington, D.C., National Academy Press, 1983
Type Document: Book
Keywords: Public Health; Decision-making; Risk Management
EPA Libraries: EHA Rl; EIA R2; EIC Edison; EJB HQ; EJE
OTS; EKB RTP Doc NAS/084; EKD Athens; ELA R5; ELB Cinn;
ELC Ann Arbor; EMA R6; EGA R8; EOB NEIC; ERA R9; ESA RIO;
ESB Corvallis
Call Number: RA445.R57
Risk Management Practices in Local Communities: Five
Alternatives (Alternative Risk Management Policies for
State and Local Governments)
Meyer, Marshall W; Solomon, Kenneth A
California Univ., Los Angeles. School of Engineering and
Applied Science.
Sponsor: National Science Foundation, Washington, DC.
Report No.: UCLA-ENG-8242; NSF/PRA-82023
May 82 49p
See also PB83-132993
Contract No.: NSF-PRA79-10804
PB83-133009
The current state of risk management practices in local communities in the United
States is discussed and some alternatives to present policies are offered. The concept
of risk management as presently used in local government is examined and results of a
survey of local and state risk managers is presented. It is shown that local risk
managers do not tend to think of risk quantitatively and that their principal activities
are directed toward compliance of standards set elsewhere. The identification of new
hazards and estimation of risks is shown to be largely absent from local and to some
extent state levels of government. It is suggested that local communities should be
given more timely scientific data concerning risk and should be freed from Federal
and state policies mandating levels of acceptable risk. (NTIS)
159
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"Risk Quantitation and Regulatory Policy
Hoel, David G; Merrill, Richard A; Perera, Frederica, P
Cold Spring Harbor, NY; Cold Spring Harbor Laboratory, 1985
Type Document: Book Series: Banbury Report 19
Keywords: Toxicology; Mathematical Models; Risk Management;
Epidemiology; Environmental Health; Government Policy
EPA Libraries: EJE OTS; EKB RTP; ELB Cin.
Call Number: RA1199.R57 1985
"The Role of Congress in Risk Management
Green, Harold P
Environmental Law Reporter 16:Aug 86, 10220-3
"The Scientific Framework for Regulation Decisions
Dixon, Robert L
U.S. Environmental Protection Agency, Office of Health
Research, Washington, DC
Comments on Toxicology. 1986. Vol. 1(1): 77-84
Understanding Risk Management: A Guide for Governments
Coe, Charles
Athens, GA., Univ. of Georgia, Institute of Government,
1980, 70p.
Type Document: Book
ISBN: 0-89854-063-1
160
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LEGAL ASPECTS .... includes law, courts, regulations; mediation vs. litigation.
"Dealing with Risk: The Courts, the Agencies and Congress
Light, Alfred R
Hunton & Williams, Richmond, Virginia
Paper presented at the Fourteenth Annual Airlie House
Conference on the Environment. May 17-18, 1985,
Airlie House, Warrenton, Virginia
To be published in Environmental Law Quarterly
EPA Libraries: EJB HQ; ELB Cine.
Dealing with Risk - The Courts, the Agencies and Congress
Fourteenth Annual Airlie House Conference on the
Environment. Proceedings held May 17-18, 1985,
Airlie House, Warrenton, Virginia
Sponsored by: The Standing Committee on Environmental Law,
Public Services Division, American Bar Association
Keywords: Risk Assessment; Risk Management; Regulatory
Agencies, Courts, Congress, Integrated Environmental
Management; Risk-Benefit Analysis
"Decision Making for Regulating Chemicals in the Environment:
A Report
Environmental Studies Board. Committee on Principles of
Dcision Making for Regulating Chemicals in the Environment
Washington, DC, National Academy Press, 1975
Keywords: Environmental Law; Chemical Regulation
EPA Libraries: EHB Narrag; EKB RTP NAS/057; EIA R2 KF3958.
C-EN; EJB HQ; EJE OTS; EKA R4; ELA R5; ELB Cinn; ELD Duluth;
A R6; EOA R8; ESA RIO
Call Number: KF3958.E5
"Don't Gut Worst Case Analysis
Yost, Nicholas C.
Environmental Law Reporter (1983). 13: 10394-10397
161
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**Legal Considerations in Risk Assessment Under Federal Regulatory Statutes
Hutt, Peter Barton
In: Assessment and Management of Chemical Risks,
Chapter 6. Washington, DC, American Chemical Society 1984
Throughout history, regulatory statutes to protect the public health and safety have
been worded in sufficiently broad and general terms to authorize the government to
utilize current scientific knowledge in determining adequate public protection. The
statutory requirements of current health and safety laws implemented by FDA, EPA,
CPSC and OSHA are sufficiently flexible to allow the adoption of whatever analytical
and decision-making methodology best represents the public interest. Implementation
of current regulatory statutes in this field is therefore constrained largely by the cur-
rent state of scientific knowledge rather than by rigid or obsolete statutory
requirements.
EPA Libraries: EJB HQ
"Managing Comprehensive Rule Making: EPA's Plan for Integrated Environment
Management
Schmandt, Jurgen
Univ of Texas at Austin
Public Administration Review (1985). March/April, 309-318
EPA Libraries: EHA Rl; EIA R2; EJA R3; EJB HQ; EKA R4;
ELA R5; ELB Cinn; EGA R8; ERA R9; ESA RIO
"An Overview of Risk-Benefit Analysis in Environmental Law
Trauberman, Jeffrey
Environmental Law Institute
The Environmental Professional (1981). Vol. 3, p. 217-223
EPA Libraries: EJB HQ
"Patterns in the Laws on Health Risks
Field, Robert I.
Analysis & Inference Inc. MA.
J Policy Analysis & Management Winter 82, VI, N2, P257 (4)
Technical Feature: Federal risk management techniques designed to identify health,
safety, and environmental hazards have proven inconsistent and confusing. A close
look at the underlying structure, however, reveals that there is a way to categorize risk
statutes and predict future legislative trends and initiates. Congressional desire to con-
trol the regulatory process is discussed. (6 References) (ENVL)
162
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"Risk and Benefit in Environmental Law
Ricci, Paolo F.; Molton, Lawrence, S.
(EPRI) and Science. Dec 4, 81, V214, N4525, P1096(5)
Technical Feature: The treatment in law of several key issues in risk assessment is
discussed: The meaning of the 1980 ruling that OSHA must demonstrate that a stand-
ard is needed to remedy a significant risk, the burden of proof under conditions of
scientific uncertainty, and the resolution of the conflict between the need to reduce
hazardous exposures and the desire for accuracy. There exist under current regulatory
statutes several paradigms for balancing costs and benefits. (35 references) (ENVL)
"The Risks of Risk Assessment and Risk-Benefit Analysis
Silverglade, Bruce A.
Food Drug Cosmetic Law Journal (1983) 38: 318-324
EPA Libraries: EIC Edison; EJB HQ
Resolving Environmental Disputes. A Decade of Experience
Bingham, Gail
Washington, DC, The Conservation Foundation, 1986
ISBN: 0-89164-087-8
"...Negotiation, mediation, consensus-building, policy Dialoges -- these and other
cooperative measures today are becoming increasingly important in settling environ-
mental disputes. These approaches, first applied in 1974, have resolved scores of con-
flicts successfully, prompting Dr. Jay Hair, Executive Vice President of the National
Wildlife Federation, to predict, 'in ten years, more environmental disputes will be
mediated than litigated...mediation is a growth industry.'"
"The Role of the Courts in Risk Management
Stewart, Richard B.
Environmental Law Reporter 16: Aug 86, 10208-15
"Safety and the Second Best: The Hazards of Public Risk
Management in the Courts
Huber, Peter
Columbia Law Review (1985^) 85: 277-337
EPA Libraries: EJB HQ; EJC Law
163
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Some Problems of Risk Balancing for Regulating Environmental Hazards
Gilbert, T.L.
Argonne National Lab., IL
Sponsor: Department of Energy, Washington, DC.
Report No.: CONF-841187-21 1984 16p
DOE environmental protection information meeting,
Albuquerque, NM, 6 Nov 1984
Type Document: Conference Proceeding
Contract No.: W-31-109-ENG-38
DE85004080/XAB
Rational regulation of environmental hazards may be based on the implicit underlying
principles that government actions should enhance the average quality of life for those
governed and maintain some degree of equity in the distribution of benefits, costs, and
risks. Issues arising from these principles have practical implications for risk
management policy in general and for the development and application of radiological
protection criteria in particular. One of the issues is the appropriate distribution of
expenditures for regulating different risks. The total resources available for risk
regulation are finite; hence, minimizing the total risk subject to this constraint is an
appropriate strategy for optimum risk management. Using a simple model, it is shown
that this strategy leads to a distribution of expenditures between different risks such
that a greater fraction is allocated to a risk with a higher cost of mitigation or control
but the allocation is limited in such a manner that the fractional contribution of that
risk to the total risk is also higher. The effect of deviating from this strategy is
examined. It is shown that reducing a single risk of concern below the optimum value
by a factor 1/F can increase the total risk by about F times the risk of concern.
Taking into account the large uncertainties in risk assessment for establishing
radiological protection criteria, it is argued that an optimum strategy for remedial ac-
tion should (1) set basic risk limits as high as reasonable; (2) use realistic, case-specific
data and analyses in deriving allowable residual contamination levels from basic risk
limits; and (3) implement a policy of reducing residual contamination to levels that are
as low as reasonably achievable (ALARA) within the constraints imposed by optimum
resource allocation. (10 references) (NTIS)
Toxic Chemicals: The Interface Between Law and Science
Davis, Earon S.; Wilk, Valerie A.
Migrant Legal Action Program, Inc.,
806 Fifteenth Street, NW, Washington, DC 20005. (202)347-5100
An introduction to scientific methods of demonstrating causation of diseases by chemi-
cal pollutants and a guide to resources on toxic chemicals. Includes a section on bibli-
ographic and organizational resources in the areas of toxics and the regulatory process,
health effects, toxics and the law, epidemiology and biostatistics, risk assessment,
directories, catalogues.
"Update: The NEPA Worst Case Analysis Regulation
Rosenbaum, Kenneth L.
Environmental Law Reporter (1984) 14: 10267-10271
164
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HEALTH RISKS .... includes occupational and non-occupational management of risks,
radiation, risk/benefit, margin of safety, cancer, genetics and public health.
**Asbestiform Fibers: Nonoccupational Health Risks
Corporate Source: National Research Council (US).
Committee on Nonoccupational Health Risks of Asbestiform Fibers.
Washington, DC, National Academy Press, 1984
Type Document: Book
Keywords: Asbestos Fibers; Toxicology; Risk Management
EPA Libraries: ESA RIO
Call Number: RA1231.A8N38 1984
"Carcinogenic Risk Management in the United States
Selikoff, Irving J.
CUNY, New York City
Presented at NY Academy of Sciences Annals: Management
of Assessed Risk for Carcinogens Conf, New York City,
Mar 17-19, 80, P283 (11)
Survey Report: The management of carcinogenic risk, both to the general public and in
working environments, in the U.S. is reviewed. Various regulatory approaches are
discussed. The dose-response approach has been widely used. The end product use
method is now being extended to include product use of a carcinogenic agent. Con-
cepts of latency, dose-induction periods, threshold limits, multiple factor interactions,
and extrapolation of animal data to humans are also considered. (15 references, 5
tables) (ENVL)
The Dioxins: Public Health Risks
Lowrence, William W.
Prospect Heights, IL, Waveland Press, 1984
"Genetic Control of Environmental Pollutants
Omenn, Gilbert S., Univ. of Washington;
Alexander Hollaender, Associated Universities, Inc. (eds.)
New York, Plenum, 1986
418p, illustrated, 0-306-416247
Type Document: Series: Basic Life Sciences. Volume 28
Keywords: Genetic Engineering, Management of Toxic
Substances, Potential Environmental Problems
This authoritative, multiauthored volume assesses strategies for the safe and effective
management of wastes and toxic substances through the use of genetically engineered
165
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microorganisms. Employing biological, traditional chemical and physical, and com-
bined approaches, leading researchers examine such topics as environmental toxicants,
the engineering of organisms to survive, environmental waste streams, and the diverse
capabilities of microorganisms. They also look at some potential problems of extending
experimental findings to environmental applications.
Source of Abstract: Publisher
EPA Libraries: EJB HQ
"The Limitations of Summary Risk Management Data
Cothern CR; Schnare, DW
Presented at a symposium entitled "Scientific Praxis
in Risk Management" at the annual meeting of the American
Association for the Advancement of Science, in Los
Angeles, CA, May 29, 1985
Drug Metabolism Reviews 17(1&2), 93-117, 1986
Discussion of the imponderables involved in developing estimates of risk due to con-
taminants in drinking water and examination of possible science policy options that
can be used to deal with these problems.
"Management of Assessed Risk for Carcinogens
Nicholson, William Jamieson
New York, New York Academy of Sciences, 1981
Type Document: Book
Keywords: Carcinogens; Environmental Health; Public Health Laws
EPA Libraries: EJE OTS; EKB RTP V.363; ELB Cine. V.363
Call Number: Q11.N5
"Managing Risk in a Technical Society: the Tanner Bill in
California
Mrak EM
Regulatory Toxicology and Pharmacology 5(4): 410-5 Dec 85
Keywords: Air Pollutants/*Toxicity; Animal; Benzene/Toxicity;
California; Chemical Industry; Health Education; Human;
*Legislation, Drug; Risk; United States Environmental Protection
Agency; 71-43-2 (Benzene)
Source: (NLM)
166
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**Margin of Safety as a Risk-Management Concept in Environmental Legislation
Thompson, Kenneth H.
Center for Policy Research, Wash DC
Columbia J Env Law Fall 79, V6, Nl, Pl(30)
Survey Report: The Clean Air Act was amended in 1970 to include the requirement
that EPA set standards for air pollutants that would allow an adequate margin of
safety to protect the public health. The Congressional intent in applying the margin of
safety concept to a public health standard is reviewed. The concept is examined in the
context of subsequently developed administrative actions, court decisions, and scien-
tific analyses. Results indicate that the margin of safety concept is inadequate for
health-risk management because it is inherently vague. A more explicit process of
weighing risks and benefits to the public should be employed. (101 references) (ENVL)
"Protecting Public Health
(EPA risk assessment and risk management efforts; 7 articles)
EPA (Environmental Protection Agency) Journal 10: 2-19 D '84
(PAIS)
Public Health Risks of the Dioxins
Proceedings of a Symposium Held in New York City on
October 19-20, 1983
Lowrence, William W
Life Sciences and Public Policy Program of the Rockefeller University
New York, The University, 1984
Keywords: Toxicology; Dioxins; Environmentally Induced Diseases;
Bibliography; Includes Index
EPA Libraries: EKB RTP
Call Number: RA1242.D55P83
**Risk/Benef it Decisons and the Public Health
Proceedings of the Third FDA (Office of) Science Symposium,
held at the U.S. Air Force Academy, Colorado Springs, Colorado,
February 15-17, 1978.
Staffa, Jeffrey A
Rockville, MD, DHEW, PHS, FDA, Scientific Liaison staff,
Office of Health Affairs, 1980
Type Document: Series: HEW publication No. (FDA) 80-1069
Keywords: Public Health Administration; Decision Making;
Risk-taking (Psychology); Medical Policy
EPA Libraries: EJE OTS
Call Number: RA427.S985
167
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**Risk by Choice: Regulating Health and Safety in the Workplace
Viscusi, W. Kip
Cambridge, Mass., Harvard Univ. Press, 1983
Keywords: Industrial Hygiene; Industrial Safety; Industry
and State; Bibliography
EPA Libraries: ELB Cinn.
Call Number: HD7654.V57 1983
**Risk Evaluation for Protection of the Public in Radiation
Accidents
Corporate Source: International Atomic Energy Agency.
World Health Organization
Vienna, International Atomic Energy Agency, 1967
Type Document: Book
Keywords: Radiation — Toxicology
EPA Libraries: ERB Las Vegas
Call Number: HD7269.A6I4 No. 21
"Safety and the Second Best: Hazards of Public Risk Management
in the Courts
Huber, Peter
Columbia Law R 85: 277-337 Mr '85
Tradeoffs involving the "efficient" risk economy, public risk, public health, and
private safety and well-being; the courts and the issue of liability. (Tables, chart)
(PAIS)
Standard Setting Standards: A Systematic Approach to Managing Public Health
and Safety Risks
Fischhof f, B
Oak Ridge National Lab., TN
Sponsor: Decision Research, Eugene, OR.; Nuclear
Regulatory Commission, Washington, DC. Office of Nuclear
Regulatory Research; Department of Energy, Washington, DC
Report No.: ORNL/SUB-7576/3
Feb 84 67p
Prepared in cooperation with Decision Research, Eugene, OR
Contract No.: W-7405-ENG-26
NUREG/CR-3508
The present analysis offers a general framework for setting health and safety stand-
ards within the nuclear industry and elsewhere. It draws upon a logical analysis of the
role of standards in hazard management and upon a historical review of the experience
that various government, industry and professional regulatory bodies have had. From
these, it derives a set of guidelines regarding when standards should be used, how they
can be derived, and what steps are needed to ensure faithful implementation. A
separate report (Fischhoff, 1983) applies this framework in an analysis of the nuclear
power safety goals, pointing to their various strengths and weaknesses. (NTIS)
168
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ECONOMIC ANALYSIS .... includes cost/benefit, cost/ effectiveness.
Benefit-Cost Analysis at EPA
Luken, Ralph A
EPA, Office of Policy, Planning and Evaluation
The Environmental Forum. Oct 1985, p. 42-46
EPA Libraries: EJB HQ
**Costs of Risk Avoidance
Dewees, Donald N
Univ of Toronto, Canada
Royal Society of Canada/et al. Risk Assessment and Perception Sym,
Toronto, Oct 18-19, 82, p!69 (12)
Conference Paper: Two studies of the costs of risk reduction involving occupational or
environmental carcinogens are described. A study was conducted under the auspices of
the Ontario Royal Commission on Asbestos on the technical feasibility and cost of con-
trolling worker exposure to asbestos fibers. The marginal cost of control varies among
work stations within a given plant. Sources of uncertainty in the cost estimates are
discussed. The costs of risk reduction were also estimated by the diesel impacts study
committee of NAS, which examined the cost of reducing the emission of potentially
carcinogenic particulates in the exhaust of diesel automobiles. Uncertainties in future
technology developments and in the health effects of such particulates were identified.
(2 graphs, 6 references, 4 tables) (ENVL)
"Economic Analysis and Risk Management: An Application to
Hazardous Wastes
(Final rept. Aug 78-Nov 81)
Anderson R; Dower R; Yang E
Environmental Law Inst., Washington, DC
Sponsor: Municipal Environmental Research Lab., Cincinnati, OH
Report No.: EPA-600/2-84-001
Jan 84 244p
Contract No.: EPA-R-805920
PB84-125012
The report evaluates the usefulness of economic analysis in designing effective and ef-
ficient hazardous waste regulations. In particular, it examines the applicability of
cost/benefit analysis to the specific problems posed by hazardous waste management.
The background for the analysis is provided by case studies of regulatory actions on
coke oven emissions, saccharin, aflatoxins, and radiation. The report also presents
several detailed case studies of past hazardous waste spills. These case studies
provided information on how hazardous waste regulations can be analyzed within a
cost/benefit framework. The report then selects two specific problems in hazardous
waste management to demonstrate qualitatively the application of cost/benefit
169
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analysis: uncontrolled dump sites and siting of hazardous waste facilities. It is clear
that inadequate data generally will prevent a formal cost/benefit analysis from being
undertaken for regulatory programs. However, significant insights can be gained by
applying economic analysis to hazardous waste regulations to the extent that available
data allow. Such an exercise allows decisionmakers to take a comprehensive and objec-
tive view of alternative regulatory policies, revealing cost and benefit relationships
and regulatory response priorities. (NTIS)
**RCRA Risk-Cost Analysis Model: Phase III Report
U. S. Environmental Protection Agency, Office of Solid Waste.
Washington, DC, ICF Inc., 1984
Document Type: Report
Keywords: Risk; Cost-Effectiveness
EPA Libraries: EJB HQ
Call Number: EPAX 8511-0032
**Risk in Benefit-Cost Analysis
Schulze, William D; Kneese, Allen V
Washington, DC, Resources for the Future, 1981
Document Type: Series
Keywords: Cost-Effectiveness
Notes: Reprinted from Risk Analysis, Volume 1,
Number 1 (March 1981)
EPA Libraries: EKB RTP
Call Number: RFF/R-188
170
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CORPORATE RISK MANAGEMENT
"Corporate Risk Assessment: Strategies and Technologies:
How to Limit the Risk in Industry
Rowe, William D
New York, M. Dekker, 1982
Type Document: Series of Special Reports: Report No. 4
Keywords: Risk Management; Risk
EPA Libraries: EJE OTS
Call Number: HD61.R68
Reducing the Carcinogenic Risks in Industry
Deisler, Paul F, Jr, (Editor)
New York: Marcel Dekker, Inc., 1984. pp. 258
Risk Management in the Chemical and Process Industries
Neumann, PK
C.I.L. Inc., Toronto
Canadian Chemical Engineering 33rd Conference 8340041
Toronto, Ontario, Canada 2-5 Oct 83
Canadian Society for Chemical Engineering (CSChE);
Societe Canadienne du Genie Chimique (SCGCh)
1983, Proceedings available: Canadian Society for
Chemical Engineering, 151 Slater St., Suite 906, Ottawa,
Ontario KIP 5H3, Canada
(CPI)
Risk Management of Existing Chemicals
Chemical Manufacturers Association
Rockville MD: Government Institutes, Inc., 1984
pp. 184
171
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BIBLIOGRAPHIES AND OTHER SOURCES ....this section highlights a variety of
documents, including bibliographies, guides, handbooks, and other general reference works
which describe management tooks useful in environmental risk management.
Dynamic Programming. 1976-February, 1984
(Citations from the Management Contents Data Base)
(Kept, for 1976-Feb 84)
National Technical Information Service, Springfield, VA
Apr 84 98p
Document Type: Bibliography
PB84-863638
This bibliography contains citations concerning dynamic programming models and
their many applications to risk management, game theory and problem solving-decision
analysis. Mathematical programming techniques are discussed relative to the varying
degrees of their usage in different segments of American business. Examples of this
modern management tool in all facets of corporate business are provided. (Contains
175 citations fully indexed and including a title list.) (NTIS)
"Risk Assessment Techniques: A Handbook for Program Management Personnel
Information Spectrum, Inc.
Corporate Source: U.S. Dept. of Defense, Fort Belvoir,
Defense Systems Management College
Washington, DC., U.S. Government Printing Office, 1983
Type Document: Book
Keywords: Risk Management; Handbooks; U.S. Dept. of Defense
EPA Libraries: EJA R3; EHA Rl 01A0003895
Risk Management Guide
Briscoe, GJ
EG and G Idaho, Inc., Idaho Falls
Sponsor: Energy Research and Development Administration
Jun 77 lllp
Contract No.: EY-76-C-07-1507
ERDA-76-45/11
Risk management requires an assessment or a knowledge of risk. This, in turn,
requires identification of hazards (sources of risk) and a determination or risk
(evaluation of the hazard degree). The hazard identification and risk analysis tech-
niques presented in this Guide are, in general, based on the MORT concept that acci-
dents result from unwanted energy flow in the absence of adequate controls and/or
barriers. This Guide presents an analytical tree designed to prevent oversight of
specific energy sources in risk identification. Hazard identification by field personnel
is also discussed. Quantitative risk analysis is discussed in the following section. A
method for summary of the risks for each energy classification is given. This method
173
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uses a graphical log-normal projection so that low probability events, which are not
adequately represented in the experience data, are included in the risk assessment.
This permits a more acceptable risk assessment since catastrophes are not ignored, even
though the actual risk is only approximated. In addition, a few examples of risk
analysis of specific hazards are given. Rudimentary probability and fault tree theory
are used in these examples. Total risk assessment and resource allocation and safety
performance trend analysis are discussed. (NTIS)
Technological Risk: A Bibliography
Covello, Vincent; Abernathy, Mark
Monticello, IL, Vance Bibliographies, 1983 83p
Type Document: Public Administration Series, P1220
ISBN: 0-88066-550-5
EPA Libraries: EJB HQ
174
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Risk
COMMUNICATION
THE PROCESS OF EDUCATING AND INFORMING AN AUDIENCE TO MAKE
BETTER PERSONAL AND SOCIETAL DECISIONS REGARDING RISK.
Informing the Decision-Maker 177
Informing the Public 179
Informing the Worker 185
175
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COMMUNICATION
INFORMING THE DECISION-MAKER
Chemical Emergency Preparedness Program: Organizing the Community,
Gathering Site-Specific Information, Contingency Plan Development,
Contingency Plan Appraisal, The Criteria,
Appendices
Environmental Protection Agency, Washington, DC
Nov 85, 171p EPA/560/7-85/012
NTIS No.: PB86-155256/REB
The document, developed by the U.S. Environmental Protection Agency (USEPA) is
part of the USEPA National Air Toxics Strategy. The purpose of the document is to
provide the public and state and local officials with information to assist them in
planning how to respond to accidental releases of acutely toxic chemicals. It provides
recommendations on how communities get organized, gather relevent information, and
develop, evaluate and update contingency plans. It also describes the criteria used by
the EPA to classify chemicals as acutely toxic and provides a list of 402 chemicals that
meet these criteria.
See also PB86-155264/REB
Keywords: *Chemical compounds, *Toxicity, *Air pollution,
*Management planning, *Hazardous materials, Sites, State government,
*Toxic substances, Environmental Protection Agency, Listings.
Communicating Environmental Health Risk Assessment and Other Risk
Information: Analysis of Strategies
Risk: a seminar series
Vertinsky I; Vertinsky P; Kunreuther H (eds.)
Univ of British Columbia, Vancouver 1981. 421-482 p.
Country of publication: Austria
Publ: International Institute for Applied Systems Analysis,
Laxenburg, Austria
Type document: Analytic of a Book
Subfile: EPA (Energy Abstracts for Policy Analysis)
Work location: Canada
To aid in the preparation of communication strategies of risk assessments in the field
of environmental health, this paper focuses upon the development of risk-
communication models. The models link existing scientific knowledge about
communications, risk-information processing and decision making with the major at-
tributes of an information strategy. (DOE)
177
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Communicating Risk Management Information to Regulators
Brown, RV
Decision Sci. Consortium, Falls Church, VA
Emergency '85—3. Int. Congress and Exhibition for Emergency,
Disaster Preparedness and Relief 8525004
Washington, DC 21-24 May 85
For ordering information contact Hazard Monthly, P.O. Box 34408,
Bethesda, MD 20817
(CPI)
**A Discussion of Some of the Problems Encountered in Communicating
Risk Assessments to Decision Makers
Cothern, CR; Marcus, WL
U.S. Environmental Protection Agency, Office of Drinking
Water (WH-550), Washington, DC
To be published in the proceedings of the annual meeting of
the Society for Risk Analysis in Washington, DC, October 1985.
Examination of the general problem areas in discussion between risk assessors and risk
managers including language problems and problems in communicating uncertainty
and probability. (12 pp)
**The Right to Know About Toxic Exposures. Implications for
Physicians
Himmelstein JS; Frunkin H
N Enel J Med. 1985 Mar 14; 312(11); 687-90
Keywords: Consumer Advocacy/Legislation & Jurisprudence;
Environmental Pollutants/*Toxicity; Information Services/ *Standards;
*Legislation; Medical; *Occupational Medicine; *Physician's Role;
*Role; *Toxicology; United States Occupational Safety and Health
Administration
178
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INFORMING THE PUBLIC
An Account of the Management of a Potential Environmental/Medical Crisis
by a Local Health Department
Craven, J; Kamen MD
Journal of Community Health 10 (l):3-9, 85
This paper is an account of what steps were necessary in the epidemiological and
medical investigation of an alleged cyanide outbreak by a local health department. It
details, in chronological sequence, the events, groups, and individuals who impacted a
situation which, at various points, caused considerable anxiety in the community.
"Citizen Action for Environmental Health: Report on a Survey
of Community Organizations
Freudenberg, N.
American Journal of Public Health 74(5): 444-8, May 84
A convenience sample of 242 community organizations involved in environmental
health issues was surveyed regarding each group's goals, activities, and problems. The
110 groups that replied identified 153 health-threatening hazards including toxic waste
dumps, pesticide spraying, and air or water pollution. The most common health condi-
tions which respondents attributed to these hazards were cancer, respiratory problems,
birth defects, and reproductive difficulties. The goal identified most frequently was
the correction of the specific hazard facing their community. To achieve this aim,
groups engaged in a variety of activities including research, public education,
demonstrations, lobbying, and legal action. Most groups reported extensive and helpful
interactions with scientists or health professionals. Respondents reported problems in
obtaining information from local health officials, other government agencies, and
industry. A majority of the groups rated their efforts at environmental health protec-
tion as being very or somewhat successful. The implications of these findings for local
health officials are discussed. (NLM)
"Comments on Informing the Public About the Risks of Ionizing
Radiation (letter)
Tschaeche, AN
Health Physics 48(3): 349-50, Mar 85
Keywords: Communication; Human; Radiation Effects; Risk
(NLM)
"Communicating on Environmental Risk
Ward, Bud
The Environmental Forum. 1986 Vol. 4, No. 9 (January), p.7
(ENV BIB)
179
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""Communicating Scientific Information About Health and Environmental
Risks: Problems and Opportunities from a Social and Behavioral
Perspective
In: Uncertainties in Risk Assessment and Risk Management
Covello, V; Moghissi, A; Uppuluri, VRR
New York, Plenum Press, 1986 .
Type Document: Chapter in Book
Keywords: Risk Communication; Methods of Communication;
Problems in Communicating
Notes: 110 references
EPA Libraries: EJB HQ
""Communicating with the Public on Environmental Risk:
Integrating Research and Policy
Conn, WD; Feimer, Nickolaus R
Virginia Polytechnic Institute and State Univ.
Env. Professional 1985, V7, Nl, p39(9)
Journal Article: Research conducted in the fields of psychology and communications is
reviewed to assist EPA and other agencies in developing improved ways of com-
municating risk information to the public. No formula has emerged that an agency
can use to allay the fears of anxious citizens faced with environmental risks. Issues
warranting further research in aiding public understanding of risk assessment and
management are cited. (ENVL)
"Community Relations in Superfund: A Handbook
(Interim Version) ICF, Inc., Washington, DC
Environmental Protection Agency, Washington, DC
Office of Emergency and Remedial Response
NTIS/PB84-209378, 132p
TD3: This handbook serves as program guidance to EPA Regional Offices and states
for conducting community relations activities in the Superfund program. The Super-
fund community relations program encourages two-way communication between com-
munities affected by releases of hazardous substances and agencies responsible for
cleanup actions. The program attempts to provide communities with accurate informa-
tion about problems posed by releases of hazardous substances; at the same time, it
gives local officials and citizens the opportunity to comment on and provide input to
technical solutions to site problems. The handbook presents guidelines for developing
community relations programs for removal actions and remedial actions. It discusses
the advantages and disadvantages of various activities that may be included in a com-
munity relations program. The handbook explains the administrative requirements for
the program. Guidance on managing community relations activities during enforce-
ment actions will be added to the handbook at a later date. Appendix A discusses how
to draft community relations plans and presents examples of community relations plans
for removal and remedial actions. Appendix B provides guidance on how to conduct
on-site discussions with local officials and citizens and on how to assess community
concerns on the basis of these discussions.
180
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"The Costs of Not Testing New Chemicals, or What You Don't Know
Can Hurt You
Choffnes, Eileen
Citizens for a Better Env., Chicago
Presented at Intl. Joint Comm. Hazard Assessment Sym.,
Ann Arbor, Apr 9-11, 79, P201(7)
Technical feature: An explosion occurred at a chemical facility in Chicago Heights,
ILL., on August 18, 1978. It resulted in the release of a pesticide to the surrounding
community. The public received no information from state and local health or en-
vironmental agencies concerning the health effects of exposure to this highly toxic
pesticide, EPN. Some people experienced symptoms, such as dizziness and nausea, at-
tributed to prolonged exposure. This incident demonstrates the importance of making
toxicity information accessible to the general public. (ENVL)
Decision Making and Risk Management by Individuals: Nitrate-Nitrogen
in the Clifton Springs, New York Public Water Supply
(Technical completion rept.)
Bisogni, CA; Lemley, AT; Fessenden-Raden, J
Cornell Univ., Ithaca, NY
Sponsor: Office of Water Research and Technology, Washington, DC
Report No.: W83-04152; OWRT-A-098-NY(1)
Oct 83 13p
Contract No.: DI-14-34-0001-2134; OWRT-A-098-NY
PB84-105501
The public water supply in Clifton Springs, New York has nitrate levels greater than
the maximum contaminant level of 10 mg N/liter. The customers have been notified
since 1978 by mail, and a Citizens' Advisory Committee was established in 1981 in or-
der to secure public cooperation in solving the problem. A survey project which in-
cluded a mail questionnaire and indepth interviews in 10% of the village households
was instituted to determine the effectiveness of both notification and resident in-
volvement in influencing the public knowledge of their water problem, their concerns
about water quality, and their willingness to pay to correct the problem. The results
indicate that public participation in decision making is an effective method of educat-
ing the community and of securing its cooperation. (NTIS)
**EDB: A Case Study in the Communication of Health Risk
Sharlin, Harold Issadore
HIS Associates, Washington, DC USEPA Office of Policy Analysis
Washington, DC, Environmental Protection Agency, January 1985
Type document: Report
Keywords: Risk Communication; News Media Reporting;
Problems in Communication
EPA Libraries: EJB HQ
181
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"Explaining Environmental Risk
Some notes on Environmental Risk Communication
Sandman, Peter M
Rutgers Univ., Cook College
Washington, DC, Environmental Protection Agency,
Office of Toxic Substances, 1986,
46 p. (REFS 15)
Keywords: Communicating with the Media; Communicating
with the Public; Risk Perception
"Flow Reduction: Developing a Public Information Program:
Final Report
Intasa, Inc.
Corporate Source: EPA Office of Water Program Operations
Springfield, VA, NTIS, 1982
Keywords: Communication in Consumer Education; Water
Conservation; Bibliography
Contract No.: 68-01-6052
PB83-150508
EPA Libraries: EJB HQ
Call Number: EPAX 8603-0145
"Grassroots Environmentalism Under Attack: Dandelions,
Pesticides, and a Neighbor's Right-to-know.
Christoffel, T.
Am J Public Health 1985 May; 75(5):565-7
Keywords: *Environmental Pollutants; Human; Illinois;
legislation; *Pesticides; United States
(NLM)
Informing People About Risk
Slovic, Paul; Fischhoff, Baruch; Lichtenstein, Sarah
In: Product Labeling and Health Risks. Banbury Report 6
Morris, L; Mazis, M; Barofsky, B. (eds)
Cold Spring Harbor, NY 1980 pl65-181
EPA Libraries: EJE OTS
Call Number: RA422.P75
Labeling in Hazard Communication
Hall, SK
189th ACS National Meeting, Miami, FL 28 Apr-3 May 85
American Chemical Society (ACS)
Abstracts available. Contact the American Chemical Society Distribution,
Room 210, 1155 16th St., NW, Washington, DC 20036
182
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*A Nonadvocate Model for Health Risk Communications
Petcovic, WL; Johnson, RH
30th Annual Meeting of the Health Physics Society, Chicago ILL,
May 26-31, 1985
Health Physics 49(1) 1985. 166p
Keywords: Radiation Risk; Politics; Society
(NLM)
**Risk Communication. We Must Talk About Risk
Thomas, Lee M
Environment 1986 Vol. 28, No. 2 (March) p4
(ENV Bib)
**Risk In a Free Society
Ruckelshaus, William D
EPA Administrator
ENV Law Reporter May 84, V14, N5, p!0190(5)
Journal article: Problems encountered by EPA in regulating public exposures to
chemical residues and products are considered. Difficulties inherent in separating risk
assessment from risk management are cited. Uncertainties about exposure and in ex-
trapolating cancer data from laboratory animals to humans further constrain the
regulatory process. Factors influencing public response to risk are surveyed, and the
need to implement community and public education programs is stressed. (ENVL)
San Diego County's Community Right-to-know Ordinance: Case
Study of a Local Approach to Hazardous Substances Control
Guidotti, TL
J Public Health Policy 1984 Sep;5(3):396-409
Keywords: Industrial Waste; Adverse Effects; *Prevention and
Control; legislation; Public Health; *Truth Disclosure; California
(NLM)
**Science in the Streets
Nelkin, Dorothy; Schwartz, Henry
Twentieth Century Fund. Task Force on the Communication
of Scientific Risk
New York, Priority Press, 1984
Document Type: Report
Keywords: Technology Assessment; Communication of
Technical Information
EPA Libraries: ELB HQ
Call Number: T174.5.T8 1984
183
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The Smokeless Tobacco Industry's Failure to Warn. A Case for the Courts
Ellington, D
J Lee Med f Chicago) 1985 Dec;6(4):489-507
Keywords: Consumer Advocacy; ""Legislation and Jurisprudence;
Human; *Tobacco; *Tobacco, Smokeless; United States
(NLM)
Toxic Chemical Information Systems and Right-to-Know
Cole, HS
Public Health Policy 1986 Spring; 7(l):28-36
Keywords: Accidents; Occupational; Civil Rights/*Legislation
and Jurisprudence; Environmental Monitoring; Environmental
Pollutants/*Adverse Effects; Human; *Information Systems;
New Jersey; Risk; Truth Disclosure; United States Occupational
Safety and Health Administration; United States
(NLM)
**Why We Must Talk About Risk: A Personal View
Thomas, Lee M
USEPA
Paper presented at the National Conference on Risk Assessment,
Washington, D.C., January 30, 1986
EPA Libraries: EJB HQ
184
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INFORMING THE WORKER
Chemical Industry Accidents, Liability, and Community Right-
to-Know
Baram, MS
Am J Public Health 1986 May; 76(5):568-72
Keywords: Accidents; *Chemical Industry; Consumer Advocacy/
""Legislation and Jurisprudence; Environmental Pollutants/
*Poisoning; Europe; Human; Risk Support, U.S. Gov't, Non-P.H.S.;
United States Environmental Protection Agency; United States
"Complying with Right-to-Know is a State Versus Federal Problem
Fox, LA
OCCUD Health Saf 1986 Apr;55(4):36-40
Keywords: Civil Rights/*Legislation & Jurisprudence;
Consumer Product Safety; ""Environmental Exposure; Human;
Industry; ""Occupational Medicine; Product Labeling/methods;
State Government; United States Occupational Safety and
Health Administration; United States
Complying with Workers' Right-to-Know Legislation
Knoeck, MJ Jr; Wadd, WS; Giese, RM
Am J Hoso Pharm 1985 Sep;42(9):1974-6
The development of a manual of drug monographs about the handling of antineoplastic
agents that complies with the Minnesota Right-to-Know Act is described. The Occupa-
tional Safety and Health Administration (OSHA) regulations require manufacturers to
provide employees with information about dangerous substances they handle as part of
their jobs. OSHA regulations exclude the health-care job sector and drugs, but many
states have passed workers' right-to-know acts that include pharmacies. Under the
Minnesota Workers' Right-to-Know Act, many antineoplastic drugs are classified as
hazardous substances. The Minnesota law applies to all employers, who must provide
information and training to all employees who handle these agents. At Midway Hospi-
tal in St. Paul, a manual containing information about antineoplastic drugs was
developed by the pharmacy department to comply with Minnesota law. The drug
monographs were written by pharmacy personnel using information received from
drug companies and published articles. The manual was used to teach technicians as
well as members of the oncology-unit nursing staff and nursing personnel at a nearby
clinic about handling antineoplastic agents. Pharmacy directors in states with right-to-
know laws must determine whether the health-care job sector and drugs are covered
and, if so, implement policies to teach employees about the handling of these toxic
agents.
185
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"Despite Preemption Threat Local Right-to-Know Laws Increase
McElveen, JC Jr.
OCCUD Health Saf 1985 Jan;54(l):20-6
Keywords: *Chemical Industry; Environmental Exposure; Human;
*Legislation; Maximum Permissible Exposure Level; Product Labeling;
*Truth Disclosure; United States; *United States Occupational
Safety and Health Administration
"Effective Management of Safety and Hygiene Information to
Promote Safe Handling of Chemicals
Carron PA; Jones K
Journal of Hazardous Materials 9(3):305-314;1984
HMTC Efficient management of safety and hygiene information is necessary to ensure
safe handling of chemicals. The legal obligations of suppliers of hazardous substances
to their employees, customers, and community are addressed. Factors affecting the ap-
plication of safety and hygiene information to reduce risk such as the quality of the
information and the effectiveness of communication of the data are included. Data
management methods using computers in different kinds of organizational structures
are outlined. (40 ref.)
Final Regulatory Impact and Regulatory Flexibility Analyses
of the Hazard Communication Standard
Occupational Safety and Health Administration, Washington, DC
Report No.: OSHA/IS-83/1027
9 Aug 83 289p
PB84-132984
This regulatory impact analysis evaluates the cost-effectiveness of OSHA's November
1983 standard on hazard communication. The current standard is largely performance-
oriented and focuses on communicating information on chemical hazards in the
workplace. The standard results in initial compliance costs of approximately $604 mil-
lion or $43 per employee. The annual cost is $159 million or only $11 per employee.
The costs of the standard are also compared to the expected costs of state and local
regulations and other considered federal regulatory actions. The benefits of the
proposed standard are measured as the discounted present value of (1) reductions in
lost earnings and medical expenses for various categories of chemical source illnesses
and injuries, (2) lowered turnover costs, and (3) property losses from chemical fires.
(NTIS)
"Handbook of Hazard Communication and OSHA Requirements
Lowry GG; Lowry RC
1985, 145 pp
CBAC COPYRIGHT: CHEM ABS: Book, hazard communication requirement; Health
hazard Communication in relation to, Occupational Safety and Health Agency
requirements
186
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The New OSHA Rules and the Worker's Right-to-Know
McGarity TO
Hastings Cent Reo 1984 Aug;14(4):38-45
Keywords: *Accident Prevention; Civil Rights/Legislation and
Jurisprudence; Informed Consent/Legislation and Jurisprudence;
Occupational Diseases/*Prevention and Control; Occupational Medicine;
*Safety; Support; U.S. Gov't; Non-P.H.S.; *Truth Disclosure;
United States; Workmen's Compensation/Legislation & Jurisprudence
OSHA's Hazard Communication Standard Requirements of Employee
Right to Know Law
Sevigny MN
Qual. Assur. Manager, Orion Res. Inc., Cambridge, MA
1985 Pittsburgh Conference and Exhibition on Analytical
Chemistry and Applied Spectroscopy, New Orleans, LA
25 Feb-1 Mar 1985
No ordering information available at the present time.
Abstract No. 921
(CPI)
"Psychology in Health Risk Messages for Workers
Cohen A; Colligan MJ; Berger P
Applied Psychology and Ergonomics Branch, National Institute
for Occupational Safety and Health, Cincinnati, OH 45226
J OCCUD Med Vol 27, ISS 8, 1985, p543-51
The content, style, and mode of company communications directed to workers regard-
ing job hazards and health risks are frequently based only on concerns for technical
accuracy and legal liability. These considerations as shaping factors in informational
messages do not ensure worker understanding and responsiveness. Moreover, the uncer-
tainty of health threats posed by many workplace chemical and physical agents, and
the delayed, insidious disorders they may portend, present formidable obstacles in this
regard. This report describes guidelines that attempt to overcome these difficulties,
with specific reference to printed forms of informational material. The guidelines are
based on concepts from the cognitive and social psychology literature, with additional
input from experts in those fields as well as representatives from management and
labor who have responsibilities for worker health education in their respective
organizations. Selected guidelines are presented and critiques are offered of samples
of hazard information materials directed to workers in light of the guidelines'
prescriptions. Field trials are planned as a follow-up.
187
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The Right to Know About Hazardous Chemicals: Local Government Responsibilities
Jef f ress, Charles
Popular Govt 51:36-40+ Winter '86
North Carolina
Adoption of the Occupational Safety and Health Act standard on hazard communication
and the Hazardous Chemical Right to Know Act. (PAIS)
**Right to Know and the Duty to Disclose Hazard Information
Baram, MS
Boston Univ. School of Public Health, MA
Am. J. Public Health Nation's Health
74:4. Apr 1984 385-390 p.
Since 1970, OSHA has used its authority to regulate various health and safety hazards
in private workplaces. Two types of OSHA regulations establish rights to know and
duties to disclose: rules dealing with specific substances, and generic access to informa-
tion rules. OSHA rules for specific hazards such as coke oven emissions, asbestos,
arsenic, acrylonitrile, cotton dust, noise, and lead each contain separate requirements
for record compilation, reporting, and worker access. Generic rights of access and
duties to disclose are afforded by three OSHA rules: the rule on inspections under the
general duty clause of the enabling statute, the access to medical and exposue records
rule, and the new hazard communication rule. Under the general duty clause and
OSHA regulation, workers have the right to request OSHA inspection, and to be
notified of any imminent dangers of death or serious physical harm discovered by the
inspector. The effectiveness of this rule is dependent on worker initiative. OSHA
inspection, and the extent to which proprietary claims limit disclosures. It is usually
invoked after some exposure has occurred, and thus has a somewhat limited role in risk
prevention. Legal and historical aspects of these regulations are discussed in detail in
this review. (REFS 38) Presentation, intensity and distribution of risk communica-
tions are prescribed. (82 references, 2 figures, 1 table) (DOE)
Right-to-Know: Implications of New Jersey's Law
Koplin, AN
J Public Health Policy 1984 Dec;5(4):538-49
Keywords: *Environmental Exposure; Health Policy/ ""Legislation &
Jurisprudence; Human Rights/*Legislation & Jurisprudence; New Jersey;
Occupational Diseases/*Prevention & Control; Safety
Right-to-Know Laws and Evaluation of Toxicologic Data
Bunn, WB
Ann Intern Med 1985 Dec;103(6 [Pt l]):947-9
Keywords: Environmental Pollutants/*Adverse Effects;
Human Rights/*Legislation & Jurisprudence; Occupational
Diseases/Chemically Induced/*Prevention & Control;
Physician's Role; Risk; Toxicology; *Truth Disclosure
188
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"The "Right to Know": Toxics Information Transfer in the
Workplace
Ashford NA; Caldart CC
Annu Rev Public Health 1985; 6:383-401
Keywords: Confidentiality/Legislation & Jurisprudence;
Environmental Exposure; Human Rights/Legislation & Jurisprudence;
Occupational Diseases/*Chemically Induced; Risk;
Truth Disclosure; United States; United States Occupational
Safety and Health Administration
The Workers Right-to-Know: Obstacles, Ambiguities and Loopholes
Richter, ED
Hebrew University-Hadassah Medical School, Jerusalem, Israel
J Health Polit Policy Law 6(2) 1981 339-349
KEEP COPYRIGHT: BIOL ABS. Telling the worker about exposure to occupational
hazards and their potentially adverse health effects has been established as an ethical
principle of occupational health and safety. Situations or issues that may result in in-
complete application or nonapplication of this principle include: the employee's need to
initiate the disclosure process, medical reluctance to disclose exposure data, long
latency periods between exposure and effect, problems of quality control, the use of
monitoring methods with low predictive value, statutory secrecy provisions, doctor-
patient communication difficulties, serious social and health problems not related to
work environment, the nonspecific nature of most work-related morbidity and the ab-
sence of any monitoring. Obligatory disclosure of exposure information is
hypothesized to spur preventive measures, environmental and personal, for short- and
long-term hazards. Where the foregoing problems interfere with full disclosure, this
norm's full preventive role may not be fulfilled. Evaluation of the effect of disclosure
requirements on promoting occupational health and safety must include attention to
this possibility.
189
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Other
Sources
ORGANIZATIONS
MEETINGS AND CONFERENCES
EDUCATION
191
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ORGANIZATIONS
Organizations are excellent sources of information about research-in-progress, cur-
rent developments, expert contacts, publications, sponsored meetings, and information
related to your particular interests. The following are some of the organizations in-
volved in influencing policy, supporting research, and advancing current thinking on
risk.
1. AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY (ATSDR)
Department of Health and Human Services
Public Health Service
1600 Clifton Road NE
Atlanta, Georgia 30333
404/452-4113
The ATSDR was established by section 104(i) of the Comprehensive Environmental
Response, Compensation and Liability Act of 1980 (94 stat. 2767; 42 U.S.C. 9601 note).
The ATSDR in cooperation with State and other Federal and local official
agencies, collects, maintains, analyzes, and disseminates information relating to serious
diseases and mortality and information relating to human exposure to toxic or hazard-
ous substances; establishes appropriate registries necessary for long-term followup or
specific scientific studies are some of its many functions.
2. AMERICAN ASSOCIATION FOR THE ADVANCEMENT OF SCIENCE
1333 H Street, N.W.
Washington, D.C. 20005
202/467-4400
This is the largest general scientific organization representing all fields of science.
Publications and meetings feature risk assessment, management, and cornmunication
within the scientific sections.
Annual Meeting.
Publications: Abstracts of annual meeting.
Selected meeting symposia are published by:
Westview Press
5500 Central Avenue
Boulder, Colorado 80301
303/444-3541
Audiotapes of selected sessions are published by:
Mobile Tapes
1741 Gardena Avenue
Glendale, California 91204
818/244-8122
Science (weekly).
193
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3. ENVIRONMENTAL PROTECTION AGENCY RISK ASSESSMENT COUNCIL
US EPA
401 M Street, S.W.
PM-220
Washington, D.C. 20460
Contact: Daniel P. Beardsley
202/382-2747
Chairman: John A. Moore
202/382-2902
Provides executive oversight of the development, review, and implementation of
risk assessment policy at EPA.
4. ENVIRONMENTAL PROTECTION AGENCY RISK ASSESSMENT FORUM
US EPA
401 M Street, S.W.
PM-220
Washington, D.C. 20460
Publications: Risk Assessment Forum Series
Chairman: Peter Preuss
202/382-7960
5. ENVIRONMENTAL PROTECTION AGENCY RISK MANAGEMENT COUNCIL
US EPA
401 M Street, S.W.
PM-220
Washington, D.C. 20460
Contact: Deborah Taylor
202/382-7960
6. NATIONAL SCIENCE FOUNDATION
Directorate for Biological, Behavioral and Social Sciences
Social and Economic Science Division
1800 G Street, N.W.
Washington, D.C. 20550
Supports basic and applied research and education in the sciences. NSF reports and
books on risk are published by:
Plenum Publishing Corp.
233 Spring Street
New York, N. Y. 10013
212/620-8000
Contact: Dr. Vincent T. Covello - Risk Assessment
202/357-7417
194
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7. RESOURCES FOR THE FUTURE, INC.
1616 P Street, N.W.
Washington, D.C. 20036
"... advances research and public education in the development, conservation, and use
of natural resources and in the quality of the environment." Other areas of research in-
clude risk assessment, management, and communication. Proposed "Center for Risk
Management" under development by William Ruckelshaus.
Publications: Research results are published in 16
subject areas. Catalog available at above
address or 202/328-5086.
Contact: Dr. Paul Portney, Director
Quality of the Environment Division
202/328-5055
8. SOCIETY FOR RISK ANALYSIS
1340 Old Chain Bridge Road
Suite 300
McLean, Virginia 22101
703/790-1745
Risk assessment professionals from varied disciplines conduct studies to understand
on a scientific basis the risks posed by technological developments.
Annual Meeting.
Proceedings of the annual meeting are published by:
Plenum Publishing Corp. (address above)
Publications: Newsletter (quarterly)
Risk Analysis (quarterly)
195
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MEETINGS AND CONFERENCES ON ENVIRONMENTAL RISK
Meetings and conferences are unique opportunities for information exchange and
identifying experts and contacts in special areas of interest. Even if one cannot
directly participate, the program announcements, abstracts and proceedings which
result can be valuable sources of information on current thinking, research and trends.
Advance notice of meetings and conferences are announced in the What's New in the
EPA Library. Several sponsors of major meetings and conferences are listed and can
be contacted for further information.
1. American Association for the Advancement of Science (AAAS).
Annual Meeting.
Sponsor: AAAS
1333 H Street, N.W. :
Washington, B.C. 20005
202/467-4400
2. Biotechnology Policy and Regulation - Conference
Sponsors: Inside EPA Weekly Report
P.O.BOX 7167
Ben Franklin Station
Washington, D.C. 20044
800/424-9068
The Center for Energy and Environmental Management
11726 Winterway Ln.
Fairfax Station, Virginia
703/250-5900
3. Risk Assessment - Conference
Sponsor: The Center for Energy and Environmental Management
11726 Winterway Ln.
Fairfax Station, Virginia
703/250-5900
4. Risk Assessment/Risk Management - Conference
Sponsor: American Bar Association
1800 M Street, N.W.
Washington, D.C.
202/331-2276
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5. Risk Management - Conference
Sponsor: New York Univ. Graduate School of Public Administration.
212/598-3725
6. Society for Risk Analysis
Annual Meeting.
Sponsor: Society for Risk Analysis
1340 Old Chain Bridge Road
Suite 300
McLean, Virginia
703/328-5055
7. Washington Conference on Risk Assessment.
Annual Meeting.
Sponsors: Inside EPA Weekly Report
P.O.BOX 7167
Ben Franklin Station
Washington, D.C. 20044
800/424-9068
703/892-8500
The Center for Energy and Environmental Management.
11726 Winterway Ln.
Fairfax Station, Virginia
703/250-5900
8. Workshop on Pragmatics of Risk Assessment
Sponsor: Society of Toxicology
1133 15th Street, N.W.
Washington, D.C. 20005
202/429-9440
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EDUCATION
There is a growing demand for fuller understanding of the issues, processes, and
techniques of risk assessment, management, and communication. Training in principles
and fundamentals of risk is responding to the need for better informed professionals.
Several educational opportunities are identified for the prospective participant to
pursue. Educational opportunities will be announced in the EPA Headquarters Library
What's New in the EPA Library.
1. Carcinogen Risk Analysis - Course
Description: "Risk analysis in occupational health with emphasis on carcinogenesis."
Sponsor: Harvard School of Public Health
Office of Continuing Education
677 Huntington Avenue
Boston, Ma. 02115
617/732-1171
2. Environmental Risk Management - Seminar
Description: Designed to provide "managerial and decisionmaking skills for public and
private sector managers and specialists in environmental health, emergency services
and regulation relating to hazardous and toxic substances."
Sponsor: New York University
Graduate School of Public Administration
212/598-3725
3. Risk Assessment
Description: "Provides a streamlined, systematic survey of the science of risk assess-
ment by outlining the basic information and methods used in the risk assessment
process. It concludes with a workshop in which participants work through a hypotheti-
cal environmental problem."
Sponsor: EPA Institute
Michael E. O'Reilly, Director
EPA HQ - 401 M Street, SW
PM-224
E-Mail EPA3880
Washington, DC 20460
FTS 8/382-2594
199
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4. Survey of Toxicologic Risk Assessment Methodologies.
Course Number: TOXI 517M
Instructor: Dr. Jerry L.R. Chandler
U.S. Food and Drug Administration
Description: "Quantitative risjc assessments are emerging as a critical component of
toxicological evaluations of chemical agents. This survey course will develop the risk
assessment models from fundamental scientific concepts. The essential mathematical
background ... Commonly used linear and nonlinear models will be analyzed. The
biochemical and biological principles linking the mathematical assumptions to the
mechanisms will be analyzed...Application of the models to carcinogenic, mutagenic,
and other toxic effects will be emphasized with recent examples of public concern* The
interaction between the degree of scientific uncertainty, ethics, values, and legal
evidentiary principles will be discussed."
Sponsor: National Institutes of Health
Foundation for Advanced Education in the
Sciences, Inc.
Building 10, Room Bl-L-101
Bethesda, Maryland 20205
310/496-7976
5. Toxicology for Attorneys, , .
Course Directors: Dr. Gary L. Lage & David B. Brushwood
215/596-8830 215/596-8947
Philadelphia College of Pharmacy & Science
Philadelphia, Pa. 19104
200
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Appendix A
REGIONAL NETWORK
FOR
RISK ASSESSMENT/
RISK MANAGEMENT
ISSUES
201
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APPENDIX A
EPA REGIONAL NETWORK
FOR RISK ASSESSMENT/RISK MANAGEMENT ISSUES
REGION
SENIOR CONTACT
Paul Keough
Deputy Regional Admin.
J.F. Kennedy Federal Bldg.
Room 2203
Boston, MA 02203
(FTS) 835-3402
E-Mail EPA9102
STAFF
OTHER MEMBERSHIPS
Tom D'Avanzo, Chair
Toxics Coordinating Comm.
(FTS) 835-3222
E-Mail EPA9136
Barbara Beck
Toxicologist
Air Management Div.
Harley LaingS
Director
Planning & Mgmt. Div.
II Alice Jenik, Acting Chief
Policy & Program
Integration Branch
26 Federal Plaza
New York, NY 10278
(FTS) 264-4296
E-Mail EPA9243
Maria Pavlova
Office of Emergency &
Remedial Response
(FTS) 264-1918
E-Mail EPA9231
Bill Muzynski.^
Deputy Regional
Administrator
III
IV
Greene Jones, Director
Environmental Services Div.
841 Chestnut Bldg.
Philadelphia, PA 19107
(FTS) 597-4532
E-Mail EPA9380
Lee DeHihns3'4
Deputy Reg. Admin.
345 Courtland St., NE
Atlanta, GA 30365
(FTS) 257-4727
E-Mail EPA9400
Roy Smith
Environmental Scientist
Environmental Serv. Div.
(FTS) 597-9857
E-Mail EPA9381
Susan Delhi
Risk Assessment Coordinator
Office of the Regional
Administrator
(FTS) 256-3776
E-Mail EPA9400
Stan Laskowski •*
Deputy Regional
Administrator
Steve Wassersug 2
Director, Hazardous
Waste Management
Bill Sanders, Director
Environmental Services
Div.
230 South Dearborn St.
Chicago, IL 60604
(FTS) 353-3808
E-Mail EPA9580
David Dolan (5S-PTSB-7)
Environmental Scientist
Pesticides & Toxic Substances
Branch
(FTS) 886-5518
E-Mail EPA9575
Milt Clark (5HT)
Chairman, Health Effects Forum
Pesticides & Toxic Substances Branch
(FTS) 886-3388
E-Mail EPA9575
203
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VI Allyn M. Davis, Director
Hazardous Waste
Managemt. Div.
1201 Elm Street
Dallas TX 75270
(FTS) 729-2730
E-Mail epa9650
Jill Lyons <
Toxics Coordinator
Air Programs Branch
(FTS) 729-9187
E-Mail EPA9661
Frances Phillips'*
Acting Regional
Administrator
VII William W. Rice
Deputy Region. Admin.
726 Minnesota Avenue
Kansas City, K.A 66101
(FTS) 757-2800
E-Mail EPA9703
VIII Alexandra Smith3
Deputy Region. Admin.
One Denver Place
Denver, CO 80202-2413
(FTS) 564-2413
E-Mail EPA9802
Bob Fenemore
Air & Toxics Div.
(FTS) 757-2835
E-Mail EPA9761
Jim Baker
Waste Management Div.
(FTS) 564-1518
E-mAIL epa9873
Suzanne Wuerthele
Air & Toxics Div.
(FTS) 564-1743
E-Mail EPA9850
Art Spratlin5
Director
Air & Toxics Div.
IX Arnold Den
Senior Science Advisor
Office of the Regional Administrator
215 Freemont Street
San Francisco, CA 94105
(FTS) 454-0906
E-Mail EPA9900
Randy SmithJ, Chief
Hazardous Waste Policy
Branch
1200 6th Avenue
Seattle, WA 98101
(FTS) 399-1261
E-Mail EPA9401
Elaine Somers
Program Analyst
Management Division
(FTS) 399-2966
E-Mail EPA9021
David Tetta
Environmental Engineer
Environmental Services Div.
(FTS) 399-1597
E-Mail EPA9051
Risk Assessment Forum
Risk Advisory Council
Risk Management Council
ATSDR Task Force
Comparative Risk Task Force
204
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Appendix B
EPA
LIBRARIES
205
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APPENDIX B
EPA LIBRARIES
Federal, State, Academic and special library collections contain various works cited
here. EPA personnel should consult the nearest library in the EPA network. Following
the entry for the EPA Headquarters Library, the Network libraries are listed by EPA
Region.
1. HEADQUARTERS LIBRARY, WASHINGTON, DC
Code: EJB
Address: U.S. Environmental Protection Agency
Headquarters Library, PM-211A
401 M Street, SW., Room 2904 WSM
Washington, DC 20460
Telephone: (202) 382-5921 (CML)
(8) 382-5921 (FTS)
Librarian: Emma McNamara
2. REGION 1, BOSTON, MASSACHUSETTS
Code: EHA
Address: U.S. EPA Region 1 Library
JFK Federal Building
Boston, MA 02203
Telephone: (617) 223-4017 or 5791 (CML)
(8) 223-4017 or 5791 (FTS)
Librarian: Peg Nelson
3. NARRAGANSETT, RHODE ISLAND
Code: EHB
Address: U.S. Environmental Protection Agency
Environmental Research Laboratory Library
South Ferry Road
Narragansett, RI 02882
Telephone: (401) 789-1071 (CML)
(8) 838-5087 (FTS)
Librarian: Rose Ann Gamache
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4. REGION 2, NEW YORK, NEW YORK
Code: EIA
Address: U.S. Environmental Protection Agency
Region 2 Library
26 Federal Plaza
New York, NY 10278
Telephone: (212) 264-2881 (CML)
(8) 264-2881 (FTS)
Librarian: Dennis Carey
5. EDISON, NEW JERSEY
Code: EIC
Address: U.S. Environmental Protection Agency
Region 2 Field Office Library
Edison, NJ 08837
Telephone: (201) 321-6762 (CML)
(8) 340-6762 (FTS)
Librarian: Dorothy Szefczyk
6. REGION 3, PHILADELPHIA
Code: EJA
Address: U.S. Environmental Protection Agency
Region 3 Library (3PM21)
841 Chestnut Street
Philadelphia, PA 19107
Telephone: (215) 597-0580 (CML)
(8) 597-0580 (FTS)
Librarian: Diane McCreary
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7. LAW LIBRARY, WASHINGTON, DC
Code: EJC
Address: U. S. Environmental Protection Agency
Law Library, LE-130L
401 M Street, SW., Room 2902
Washington, DC 20460
Telephone: (202) 382-5919 (CML)
(8) 382-5919 (FTS)
Librarian: Barbara Pedrini Morrison
8. ANNAPOLIS .MARYLAND
Code: EJD
Address: U.S. Environmental Protection Agency
Central Regional Laboratory (CRL) Library
839 Bestgate Road
Annapolis, MD 21401
Telephone: (301) 224-2740 (CML)
(8) 922-3752 (FTS)
Librarian: Meg Munro
9. NON-CONFIDENTIAL INFORMATION CENTER, WASHINGTON, DC
Code: EJE
Address: U.S. Environmental Protection Agency
Office of Toxic Substances
NCIC, TS-793
401 M Street, SW.
Washington, DC 20460
Telephone: (202) 382-3529 (CML)
(8) 382-3529 (FTS)
Librarian: Doug Sellars
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10. REGION 4, ATLANTA, GEORGIA
Code: EKA
Address: U.S. Environmental Protection Agency
Region 4 Library (G6)
345 Courtland Street, NE.
Atlanta, GA 30365-2401
Telephone: (404) 347-4216 (CML)
(8) 257-4216 (FTS)
Librarian: Gayle Alston
11. LIBRARY SERVICES OFFICE, RESEARCH TRIANGLE PARK, NORTH
CAROLINA
Code: EKB
Address: U.S. Environmental Protection Agency
Library Services Office, MD-35
Research Triangle Park, NC 27711
Telephone: (919) 541-2777 (CML)
(8) 629-2777 (FTS)
Librarian: Libby Smith
12. GULF BREEZE, FLORIDA
Code: EKC
Address: U.S. Environmental Protection Agency
Environmental Research Laboratory (ERL) Library
Sabine Island
Gulf Breeze, FL 32561
Telephone: (904) 932-5311, ext. 218 (CML)
(8) 686-90ll,ext. 218 (FTS)
Librarian: Susan Means
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13. ATHENS, GEORGIA
Code: EKD
Address: U.S. Environmental Protection Agency
Environmental Research Laboratory Library
College Station Road
Athens, GA 30613
Telephone: (404) 546-3324 (CML)
(8) 250-3324 (FTS)
Librarian: Janice Sims
14. OAQPS.RESEARCH TRIANGLE PARK, NORTH CAROLINA
Code: EKE
Address: U.S. Environmental Protection Agency
Office of Air Quality Planning and Standards
826 Mutual Plaza, MD-16
Research Triangle Park, NC 27711
Telephone: (919) 541-5514 (CML)
(8) 629-5514 (FTS)
Librarian: University of North Carolina Library School
Graduate Student
15. ASRL-METEOROLOGY, RESEARCH TRIANGLE PARK, NORTH CAROLINA
Code: EKF
Address: U.S. Environmental Protection Agency
ASRL - Meteorology Division
Library (MD-80)
Research Triangle Park, NC 27711
Telephone: (919) 541-4536 (CML)
(8) 629-4536 (FTS)
Librarian: Evelyn Poole-Kober
211
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16. REGION 5, CHICAGO
Code: ELA
Address: U.S. Environmental Protection Agency
Region 5 Library
230 South Dearborn Street., Room 1670
Chicago, IL 60604
Telephone: (312) 353-2022 (CML)
(8) 353-2022 (FTS)
Librarian: Lou W. Tilley
17. CINCINNATI, OHIO
Code: ELB
Address: U.S. Environmental Protection Agency
Andrew W. Briedenbach Environmental Research
Center Library
26 W. St. Clair Street
Cincinnati, OH 45268
Telephone: (513) 569-7707 (CML)
(S) 684-7707 (FTS)
Librarian: Jonda Byrd
18. ANN ARBOR, MICHIGAN
Code: ELC
Address: UJS. Environmental Protection Agency
Motor Vehicle Emission Laboratory
Library
2565 Plymouth Road
Ann Arbor, MI 48105
Telephone: (313) 668-4311 (CML)
(8) 374-8311 (FTS)
Librarian: Debra Talssma
212
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19. DULUTH, MINNESOTA
Code: ELD
Address: U.S. Environmental Protection Agency
Environmental Research Laboratory
Library
6201 Congdon Boulevard
Duluth, MN 55804
Telephone: (218) 720-5538 (CML)
(8) 780-5538 (FTS)
Librarian: Mary Harden
20. REGION 6, DALLAS, TEXAS
Code: EMA
Address: U.S. Environmental Protection Agency
Region 6 Information Center
1201 Elm Street
First International Building
Dallas, TX 75270
Telephone: (214) 767-7341 (CML)
(8) 729-7341 (FTS)
Information Center Coordinator: Nita House
21. ADA, OKLAHOMA
Code: EMB
Address: U.S. Environmental Protection Agency
Robert S. Kerr Environmental Research
Laboratory Library
P.O. Box 1198
Ada, OK 74820
Telephone: (405) 332-8800 (CML)
(8) 743-2241 (FTS)
Librarian: Stanley Shannon
213
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22. REGION 7, KANSAS CITY, KANSAS
Code: ENA
Address: U.S. Environmental Protection Agency
Region 7 Library
726 Minnesota Avenue
Kansas City, KS 66101
Telephone: (913) 236-2828 (CML)
(8) 757-2828 (FTS)
Librarian: Constance McKenzie
23. REGION 8, DENVER, COLORADO
Code: EGA
Address: U.S. Environmental Protection Agency
Region 8 Library, 8PM-IML
999 18th Street, Suite 1300
Denver, CO 80202-2413
Telephone: (303) 293-1444 (CML)
(8) 564-1444 (FTS)
Librarian: Dolores Eddy
24. DENVER, COLORADO
Code: EOB
Address: U.S. Environmental Protection Agency
National Enforcement Investigations Center Library
Building 53, Box 25227
Denver Federal Center
Denver, CO 80225
Telephone: (303) 236-3219 (CML)
(8) 776-3219 (FTS)
Librarian: Dorothy Biggs
214
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25. REGION 9, SAN FRANCISCO, CALIFORNIA
Code: ERA
Address: U.S. Environmental Protection Agency
Region 9 Library
215 Fremont Street, 6th Floor
San Francisco, CA 94105
Telephone: (415) 974-8082 (CML)
(8) 454-8082 (FTS)
Librarian: Marsha Saylor
26. LAS VEGAS, NEVADA
Code: ERB
Address: U.S. Environmental Protection Agency
Environmental Monitoring Systems Laboratory Library
944 E. Harmon Avenue
(P.O. Box 15027, Zip 89114)
Las Vegas, NV 89109
Telephone: (702) 798-2648 - 2646 (CML)
(8) 545-2648 - 2646 (FTS)
Librarian: Doreen Wickman
27. REGION 10, SEATTLE, WASHINGTON
Code: ESA
Address: U.S. Environmental Protection Agency
Region 10 Library
1200 Sixth Avenue
Seattle, WA 98101
Telephone: (206) 442-1289 or 1259 (CML)
(8) 399-1289 or 1259 (FTS)
Librarian: Julienne Sears
215
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28. CORVALLIS, OREGON
Code: ESB
Address: U.S. Environmental Protection Agency
Corvallis Environmental Research Laboratory Library
200 SW 35th Street
Corvallis, OR 97333
Telephone: (503) 757-4731 (CML)
(8) 420-4731 (FTS)
Librarian: Betty M McCauley
216
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Appendix C
COMMERCIAL
DATABASES
SEARCHED
217
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APPENDIX C
DATABASES SEARCHED
The following commercial databases and period of time were searched in preparing
this Guide:
National Library of Medicine
U.S. Dept. of Health and Human Services
Bethesda, Maryland 20209
Phone: 301/496-6193
File Name Code in Guide Coverage File #
Toxline (NLM) 1981 - Sep 1986
(MEDLINE and CANCERLIT were also searched but duplicated many of the relevant
references selected for this bibliography).
Dialog Information Services, Inc.
Palo Alto, California 14304
Phone: 800-227-1960
800-982-5838 (in California)
File Name Code in Guide Coverage File #
Compendex (Comp) 1970 - Sep 1986 File 8
Conference Papers Index (CPI) 1973 - Apr 1986 File 77
DOE Energy (DOE) 1983 - May 1986 File 103
El Engineering Meetings (El) 1979 - Sep 1986 File 165
Enviroline (ENVL) 1970 - Apr 1986 File 40
Environmental Bibliography (ENV BIB) 1973 - Sep 1986 File 68
GPO Monthly Catalog (GPO) Jul 1976 - Aug 1986 File 66
NTIS (NTIS) 1964 - Sep 1986 File 6
PAIS International
[Public Affairs Info Service] (PAIS) 1976 - Aug 1986 File 49
The EPA Information Systems Inventory (ISI) contains descriptions of databases and
modeling systems developed by EPA:
U.S. Environmental Protection Agency
EPA HQ Library PM-211A
Washington, D.C. 20460
File Name Code in Guide Coverage File #
Information (ISI) 1986 update
Systems
Inventory
219
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