Risk Assessment,
Management Communication

A Guide to Selected Sources
C OIV! r\/l U N IC A TIO N

-------
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

-------
                    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

-------
                                                  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

-------
//  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

-------
                                   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

-------
APPENDIX A	   201

EPA Regional Network for Risk Assessment/	   203
     Risk Management
APPENDIX B	   205

EPA Libraries	   207


APPENDIX C	   219

Databases Searched	   217

-------
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

-------
                                                           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.

-------
  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.

-------
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

-------
                                                       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

-------
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

-------
 "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

-------
"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

-------
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

-------
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

-------
"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

-------
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

-------
"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

-------
"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

-------
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

-------
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

-------
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

-------
 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

-------
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

-------
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

-------
**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

-------
"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

-------
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

-------
"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

-------
**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

-------
"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

-------
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

-------
"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

-------
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

-------
**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

-------
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

-------
"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

-------
**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

-------
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

-------
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

-------
"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

-------
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

-------
"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

-------
"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

-------
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

-------
 •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

-------
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

-------
**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

-------
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

-------
"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

-------
"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

-------
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

-------
 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

-------
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

-------
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

-------
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

-------
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)
                                         55

-------
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)


                                         56

-------
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
                                         57

-------
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
                                         58

-------
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)
                                         59

-------
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)
                                         60

-------
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)
                                         61

-------
"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)
                                         62

-------
"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


                                         63

-------
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)
                                         64

-------
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


                                         65

-------
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)
                                         66

-------
"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
                                         67

-------
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
                                         68

-------
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)
                                         69

-------
 *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)


                                         70

-------
**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,
                                         71

-------
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


                                          72

-------
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-
                                         73

-------
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)

-------
"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
                                         75

-------
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)
                                         76

-------
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:


                                         77

-------
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)
                                         78

-------
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
                                         79

-------
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
                                          80

-------
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)
                                         81

-------
"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


                                         82

-------
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)
                                         83

-------
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)


                                          84

-------
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)
                                         85

-------
**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)
                                         86

-------
"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.
                                         87

-------
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


                                         89

-------
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)
                                         90

-------
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)
                                         91

-------
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

-------
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
                                          94

-------
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
                                         95

-------
**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
                                         96

-------
"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

-------
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

-------
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

-------
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

-------
"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

-------
 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

-------
 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

-------
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

-------
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

-------
"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)
                                        108

-------
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
                                      109

-------
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

-------
"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

-------
"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
                                        113

-------
              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.
                                        115

-------
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)
                                       117

-------
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)
                                       118

-------
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)
                                        119

-------
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)
                                       120

-------
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)
                                        121

-------
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)
                                        122

-------
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)
                                      123

-------
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)
                                       124

-------
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)
                                       125

-------
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)
                                       126

-------
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)
                                       127

-------
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

-------
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)
                                        129

-------
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)
                                        130

-------
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)
                                       131

-------
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

-------
                                  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
                  133

-------
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

-------
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

-------
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

-------
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

-------
"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

-------
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

-------
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

-------
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

-------
"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
                                        143

-------
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
                                         144

-------
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

-------
"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

-------
"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

-------
"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

-------
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

                                         149

-------
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

-------
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)
                                        151

-------
 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

-------
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

-------
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
                                        155

-------
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

-------
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

-------
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

-------
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

-------
"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

-------
 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

-------
**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

-------
"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

-------
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

-------
 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

-------
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

-------
**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

-------
**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

-------
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

-------
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

-------
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

-------
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

-------
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

-------
                                    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

-------
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

-------
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

-------
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

-------
""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

-------
"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

-------
"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

-------
*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

-------
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

-------
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

-------
"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

-------
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

-------
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

-------
"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

-------
          Other
        Sources
ORGANIZATIONS
MEETINGS AND CONFERENCES
EDUCATION
   191

-------
 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

-------
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

-------
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

-------
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

-------
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
                                        198

-------
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

-------
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

-------
Appendix A
    REGIONAL NETWORK
              FOR
     RISK ASSESSMENT/
     RISK MANAGEMENT
            ISSUES
201

-------
                                                              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

-------
  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

-------
Appendix B
          EPA
       LIBRARIES
 205

-------
                                                           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
                                      207

-------
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
                                        208

-------
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
                                       209

-------
 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
                                       210

-------
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

-------
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

-------
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

-------
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

-------
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

-------
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

-------
Appendix C
       COMMERCIAL
       DATABASES
        SEARCHED
  217

-------
                                                                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

-------