ist Of !h« Adminif!r*tB' SAB-££-S
l STefmfifian Sei«n«* AdviJOfy Sairi} Jyly 19S?
Afi«ncy Washington, DC EQ4S8
Report of the
Integrated Environmental Management
Subcommittee
Review of the
Office of Policy, Planning
and Evaluation's
Integrated Environmental
Management Program
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\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
^ WASHINGTON. D.C. 20460
SAB-EC-87-Q34
July 24, 1987
Honorable Lee M. Thomas
Administrator ;--.-.r ...
U. S. Environmental Protection Agency r"'L A-'-M-%'^T- • • •
401 M Street, S. W.
Washington, D, C. 20460
Dear Mr. Thomas:
The Science Advisory Board's Integrated Environmental Management
Subcommittee has completed its review of the Office of Policy, Planning
and Evaluation's Integrated Environmental Management Program (IEMP) and
is pleased to submit its final report to you.
The Subccntnittee's review focused largely on the geographic studies
initiated by the program and the development of a health scoring methodology
for non-carcinogens. The Subcommittee concludes that the conceptual
approaches employed in the geographic studies represent an important
component of EPA's overall effort to develop and/or apply methodologies
to establish environmental priorities. In particular, they provide a
valuable means for developing closer working relationships with state and
local governments and the general public in evaluv.ing area-or site-
specific risks and in devising effective strategi*-* to communicate risks.
These efforts constitute some of the most imports;^ achievements of the
program to date.
The program's lack of clearly stated scientific assumptions and
objectives, and its need for a more consistent approach to peer review,
constitute its roost serious technical deficiencies. The absence of
consistently documented assumptions and objectives, and the ad hoc approach
to peer review, has created difficulties in assessing whether the program
as a whole, or specific studies, have achieved their overall goals.
The IEMP has developed a methodology to represent the dose-response
relationship for non-carcinogenic agents. The Subcommittee has reviewed
this methodology and, in general, concludes that tv;e IEMP should initiate
A broader Agency effort to evaluate this roethodolojy in the context of
developing risk assessment guidelines and procedures. The evaluation
of this particular methodology requires an in-depth assessment of its
repeated application and, until this is undertaken, the IEMP should not
use it for decision making purposes.
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These and other issues reviewed by the Subcommittee are included in
the attached report. The Subcommittee appreciates the opportunity to
review this program and requests that the Agency formally respond to its
scientific advice.
Sincerely,
Ronald Wyzga, Chal
Integrated Environmental
Management Subcommittee
Science Advisory Board
Norton Nelson, Chairman
Executive Cownittee
Science Advisory Board
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SAB-EC-87-034
REVIEW OF THE OFFICE OP POLICY, PLANNING AND EVALUATION'S
INTEGRATED ENVIRONMENTAL MANAGEMENT PROGRAM
Integrated Environmental Management Subcommittee
Science Advisory Board
U* S* Environmental Protection Agency
July 1987
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11
U. S. ENVliONMENTAL PiOIBCriQN
NOTICE
This report has been written as a part of the activities of the
Science Advisory Board, a public advisory group providing extramural
scientific information and advice to the Administrator and other officials
of the Environmental Protection Agency. The Board is structured to
provide .a balanced expert assessment of scientific matters related to
problems facing the Agency. This report has not been reviewed for approval
by the Agency and, hence, the contents of this report do not necessarily
represent the views and policies of the Environmental Protection Agency,
nor of other agencies in the Executive Branch of the Federal government,
nor does mention of trade names or commercial products constitute
endorsement of recommendation for use.
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11X
U. S. SNVIiCXSIMENTAL PROTECTION AGENCY
SCIENCE ADVISORY BOARD
Integrated Environmental Management Subcommittee
Dr. Ronald Wyzga, Chairman
Electric Power Research Institute
3412 Hillview Avenue
Post Office Box 1041
Palo Alto, California 94303
Dr. Stephen L. Brown
Environ Corporation
1000 Potomac Street, N. W.
Washington, D. C»
Dr. Thomas Clarkson
University of Rochester
Medical Center
Box RBB
575 ElinwQod Avenue
Rochester, New York 14642
Dr. Herbert H. Cornish
830 West Clark Road
Ypsilanti, Michigan 48198
Dr. Robert Frank
Department of Environmental
Health Sciences - JHSHPH
615 North Wolfe Street
Baltimore, Maryland 21205
Dr. Rolf Hartung
School of Public Health
University of Michigan
Ann Arbor, Michigan 48109
Terry F. Yosie, Director
Science Advisory Board
U. S. Environmental Protection
Agency
401 M Street, S. W.
Washington, D. C. 20460
Dr. Thomas Burke
New Jersey Department of Health
Division of Occupational and
environmental Health CN 360
Trenton, New Jersey 08625
Dr. Yoram Cohen
Department of Chemical Engineerin
'J.C.L.A.
Roan 5531
3oelter Hall
Los Angeles, California 90024
Dr. Terry Davies
Executive Vice President
The Conservation Foundation
1250 24rd Street, N. W.
Washington, D. C. 20037
Dr. James Gryhl
7610 N, Christie Drive
Tucson, Arizona 85718
Dr* Paul Lioy
University of Medicine and
Dentistry of New Jersey
Robert Wood Johnson Medical
School
675 Hoes Lane
Piscataway, New Jersey 08854
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IV
Dri Francis McMichael
,The Blenko Professor of
Environmental Engineering
Department of Civil Engineering
Carnegie Mellon University
5000 Forbes Avenue
Pittsburgh, Pennsylvania 15213
Dr. WSarner North
Principal,, Decision Focus, inc.
Los Altos Office Center
Suite 200
4984 El Catnino Real
LOS Altos, California 94022
Dr, Ellen Silbergeld
Chief Toxics Scientist
Environmental Defense Fund
1525 18th Street, N. W.
Washington, D, C. 20036
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TABLE OF CONTENTS
Page Murober
I,
II.
Ill,
IV*
V.
VI,
VII,
VIII.
IX.
X.
XI.
XII.
Executive Summary
Introduction
A. Charge to the Subcommittee
B, Evolution of the Integrated Environmental
Management Program (IEMP)
C. Subcommittee Review Procedures
Part Qnej objectives, Design, Implementation
and Results 06 projects in the IEMP
Process
The IEMP Objectives
Project Design
Project Incrementation
Project Results
Health Scoring Methodologies
Part Twoi The Philadelphia, Baltimore, Sam:. 3 Clara
Valley and Denver Geographic Presets
Philadelphia IEMP Project
Baltimore IEMP Project
Santa Clara Valley IEMP Project
Denver IEMP Project
Appendices
1
5
5
6
8
9
10
12
14
17
19
23
24
27
35
42
Appendix A: Letter Fran Mr. Daniel Beards!'-'/ to
Dr. Ronald Wyzga.
Appendix B: Subcommittee Report on EPA's Draft
Kanawha Valley Toxics Screening Study,
May 21, 1987.
Appendix C: Subcommittee Meeting Agendas
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I. EXECUTIVE SUMMARY
The Integrated Environmental Management Subcommittee of the Science
Advisory Board has completed its review o£ the Office of Policy, Planning
and Evaluation's Integrated Environmental Management Proyrara (IEMP). The
Subccrarnitt.ee"s review focused largely on the geographic studies undertaken
by the program and the development of a health scoring methodology for non-
carcinogens. Throughout its review, the Subcommittee solicited statements
from, the program's managers and staff about its overall objectives and
the criteria to be used for evaluating whether the program had achieved
its objectives. The Subcommittee followed this effort by assessing the
technical strengths and weakness of the current program and recommending
needed changes*
The Subcommittee concludes that the conceptual approaches used by the
Integrated Environmental Management Program represent an important component
of EPA's overall effort to develop and/or apply methodologies to establish
public health and environmental priorities* Studies conducted under the
auspices of this program constitute large technical challenges and provide
valuable experience to EPA staff, particularly those working in regional
offices* And, finally, they provide a valuable means for developing
closer working relationships with state and local officials and the
general public in evaluating site-or area-specific risks and in devising
effective strategies to communicate risks.
There is a clear need to assess environmental issues from a multi-
media perspective. Conducting only medium-specific analyses can lead to
ignoring more serious issues in another medium or to simply transferring a
problem fron one medium to another. The IEMP process offers one weans of
addressing these issues, taking into account transport and transfer of toxics
across ifledia and exposures from several media simultaneously. To date,
however, IEMP has not exploited this capability to •cs potential. In part,
this may reflect the nature of the areas studied, bit greater efforts
by IEMP to use its capability are needed.
In the course of decision making, EPA and state and local govern-
ments identify priority environmental problems in specific localities or
regions. The IEMP provides a set of tools that can assist this effort.
While its applications, to date, can be improved, the results of the IEMP
studies {reflecting both EPA. and state and local expertise) have suggested
some environmental problems in specific geographic ttreas, and have also
indicated that some issues previously perceived as very important are of
lesser concern. The analytical tools used in the I'JIMP studies also may
provide technical support for environmental management decisions that
otherwise may be based upon a more subjective treab-wnt of information,
The latter reflects the need for systematic anc objective approaches
to environmental decision making. Methods that try to address all facets
of an issue comprehensively and to reduce them to a conmon inetric such as
risk provide significant support to decision makers by helping than to
more specifically frame the problems they are seeking to resolve, and by
aiding them in identifying the raost important risks.
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At the same time, the use of IEMP decision tools should never become
the sole basis Cor either identifying or managing environmental problems
by any level of governmental decision makers. Rather, such tools should
be used in concert with the practical experience of citizens and decision
makers. The Subccromittee concludes that the IEMP is most appropriately
used when it stimulates decision [takers to ask questions and seek data
concerning the identification of the most significant public health and
environmental problsns.
One of the most important achievements of the IMP has been its positive
interaction with the host communities in developing the geographic studies.
The IEMP has proven to be a focal point for presenting scientific concepts
and information to coromunities and relating them to the eventual management
of local environmental problems. An important benefit of this effort has
been community education about environmental issues and ways to evaluate
and ecnwiunicate these issues.
The program's need for clearly stated scientific assumptions, documen-
tation and objectives constitutes its most serious technical weakness.
While not a research or risk assessment program per se, the IEMP greatly
depends upon technical data as a basis for priority setting. Thus, clear
statements regarding scientific assumptions and objectives toward which
data are applied constitute a necessary aspect of the program. The fre-
quent absence of these factors has created difficulties for peer reviewers
and users of IMP studies in developing reference points to evaluate
whether the program as a whole, or its specific studies, have achieved
their object ivest Hie frequent lack of indicators or criteria for judg-
ing program or project success or failure has made it difficult to system-
atically identify and institute corrective steps at earlier stages of
project or program development. This latter characteristic has also re-
resulted from staff turnover.
The Subcommittee experienced rauch difficulty in evaluating the
This difficulty stemmed, in large part, from the ne«ds cited in the pre-
vious paragraph. Instances of inadequate documentation include: the de
facto preference for using cancer models? inconsistent use of exposure
data and pathways; delineating which assumptions were chosen because of
scientific compared to administrative/political considerations; and the
lack of criteria for using quantitative estimates for purposes of priority
setting and screening versus risk assessment.
A second source of difficulty stemmed from the fact that, as an
evolving program, the IEMP is a moving target, and -;ntil a program defines
its objectives it is difficult to evaluate its performance* Finally,
contrary to the Subecmmit tee's initial preconcert ion -9, the IEMP is not a
model or even a method, but raore of a process that ,ises several highly
variable methods, with health risk estimates providirtg the underlying
metric of the process. This characteristic further emphasizes the program's
need to adequately document its use of scientific
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quality control were adopted for the program as a whole or for the guidance
of managers of individual projects. Similarly, no consistently designed
or implemented process of peer review existed at the program or project
levels. Technical advisory panels established for specific projects have
not always consisted of individuals who were technically trained in the
scientific disciplines required for a thorough review.
The IEMP has developed an approach both for health scoring methodologies
for carcinogens and non-carcinogens, screening exercises to identify
potential problems and for more detailed analyses to evaluate options for
risk management. EPA has developed guidelines for quantitatively assessing
cancer risks that have undergone extensive peer review. Evaluating
non-carcinogens is more difficult because there exists, at present, no
clear scientific consensus on the appropriate methods to quantitatively
assess these agents. The IEMP has developed a method to represent the
dose-response relationship for non-carcinogenic agents. The Subcommittee
has reviewed the method and, in general, concludes that the IEMP should
stimulate the Agency as a whole to consider such methods, among others,
in the future development of risk assessment guidelines and procedures.
the evaluation of a method, however, requires an in-depth assessment of its
repeated application and, until this is undertaken, the IEMP should not
use its method in decision making. To date, this method has not been
applied to any significant degree in existing IEMP projects.
Maintaining the scientific expertise necessary to successfully
address the range of issues confronting integrated environmental management
is beyond the current (or, most likely, the future) capability of the
IEMP, or any other individual office within EPA. r-. :-nay not be necessary
that any single office within EPA possess all of t:\-.* needed scientific
skills for IEMP projects, as long as effective mea;^ of exchanging technical
information and staff exist. In the projects evaluated in this review,
the IEMP has not always made effective use o£ other -scientific talents
within EPA and the scientific community concerning multi-media analyses.
At the Seme time, scientific talent in ORD, EPA research centers and
program offices, Other Federal agencies and the scientific community
should participate in the activities of the program.
The practice of scientific assessment encounters many uncertainties,
and this is especially true when comparing the risks of environmental
pollution across media. To reduce the possibility that multi-raedia
assessments will be misinterpreted, it is essential to state clearly the
various uncertainties that surround the risk estimation process in at least
four areas* identification of the hazard (toxicity), exposure assessment,
dose-response assessment and characterisation of th-; risk. The IEMP recognizes
the importance of this issue but, to date, it has no£ employed a conceptually
unified framework for addressing risk and has not consistently presented
a clear identification of the major uncertainties in its efforts to screen,
rank and assess risk.
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1. The IEWP needs to adopt clearly articulated, measurable objectives for the
program as a whole and for individual projects at the time of their
initiation. Development of such objectives will assist staff and manage-
ment in judging the success of the program, or identify areas for
subsequent modification. Vaguely stated objectives can result in
misdirected efforts and unrealistic expectations. Measurable objectives
also can help identify the broader role that IEMP may play within EPA.
2. The program should more clearly document the scientific assumptions it
uses and communicate the limitations and uncertainties associated with the
results of its various studies. This is especially important in aiding
EPA and state and local management apply IEMP concepts and results to
define risk management priorities. It is equally important that this
effort be pursued in helping the public better understand the role
and limitations of scientific assessment, an area where the IEMP has
already achieved some preliminary successes. The Subcommittee recognizes
that the presentation of scientific uncertainties is also a large
challenge for other programs within EPA and for the scientific community.
3. The IEMP should identify the range of scientific disciplines needed
to maintain competency for the variety of scientific issues addressed in
the program. It should compare the current in-house ejqpertise with the
expertise available in other EPA programs, research laboratories and
centers. The I HIP should develop a plan to develop cooperative working
relationships with these groups in the beginning and subsequent phases of
studies to gain access to scientific talent, data, methodologies and
other resources, thereby maximizing its own cap tbilities,
4, The Subcommittee recommends that the IEMP more ^gressively seek
technical input from experts in the environment I and scientific conmunity
who are knowledgeable about the design and impli. Dentation of integrated
environmental analyses. The participation of such experts will infuse
the program with additional scientific skills and will add to its refine-
ment and ultimate acceptance by the scientific c- immunity* The IEMP
should develop explicit quality control criteria at both the program
and project levels for EPA staff and contractors as well as state and
local officials to ensure consistent adherence to acceptable scientific
standards. It should adopt a practice of rigorous peer review for both
the design and implementation of its studies. Insofar as the program
addresses scientific issues, it should aggress iv->ly encourage the
technical staff to participate in and present th-ir work at scientific
conferences and to submit scientific papers that address study results
or methodology development to refereed journals.
5. The IEMP should submit its method to assess dose-response relationships
for non-carcinogenic agents to EPA's Risk Assessinent Forum, The Forum
should evaluate the method, present its analyses for peer review and
publish its results. Such an effort should assist EPA and the scientific
community in developing a consensus approach for quantitatively
evaluating non-carcinogenic agents.
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II. INTBDDUCTION
At the request of the Deputy Administrator of the 0. S. Environ-
mental Protection Agency (EPA} and the Assistant Administrator for Policy,
Planning and Evaluation, the Science Advisory Board (SAB) agreed to
conduct a scientific review of the Agency's Integrated Environmental
Management Program (IEMP). This request paralleled a December 3, 1985
mccnmendation by Dr. Ellen Silbergeld, a member of the SAB Executive
Ccmtnittee, in a letter to SAB Chaicman Dr. Norton Nelson. Dr. Silbergeld
recommended that the Board undertake a special review of this program
because of its implications for the Agency's research program and its
role in EPA's scientific assessment and policy analysis activities.
The SAB Executive Cemmittee discussed these issues and recom-
mendations at its January 28-29, 1986 nneeting and unanimously voted to
form an Integrated Environmental Management Subcommittee to carry out the
review* The Subcommittee was instructed to evaluate the scientific
assumptions, methodologies and conclusions developed or used by the IEMP
program and to make recommendations pertaining to their application or
improvement. In addition, the Executive Cownittee directed the Subcommittee
to separately review the technical adequacy of a specific project directed
by the IEMP and EPA Region III for the Kanawha Valley/ West Virginia.
Hie Subcommittee issued a separate report on EPA's Draft Kanawha Valley
Toxics Screening Study on May 27, 1987.
The Subcommittee recruited a number of scientific experts to
conduct its review. Among the scientific areas represented were bio-
statistics, decision analysis, civil engineetringf chemical engineering,
epidemiology, exposure assessment, model development and validation,
pulmonary medicine, social science and toxicology.
A, Charge to the Subcommittee
The specific charge to the IEMP Subcommittee 1i eludes the following
issues:
o Evaluating the appropriateness of the overall scientific approach
used in the Integrated Environmental Management Program. Is the approach
adequate to address the kinds of questions for which it had been designed?
o Assessing the adequacy of models used and the clarity and reason-
ableness of the assumptions built into the models, ^ere appropriate
scientific conclusions drawn from the application of the models? The
Subcommittee should also review the adequacy of dat^ integration, the
conclusions drawn from using data and models and the integration of data
and models across IEMP studies.
o Reviewing the health scoring methodology anu the treatment of
non-cancer health effects.
o Assessing the expression of the outputs of the methodology and
the quality of the uncertainty analyses.
o Commenting on the existing and potential uses of the Integrated
Environmental Management Program within EPA.
o Conducting a specific scientific review of the data, methods and
conclusions for the Kanawha Valley, West Virginia project.
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B* Evolution of the Integrated Environmental Management Program
The development of EPA's Integrated Environmental Management
Program represents an Agency response to a concern by its managers and
technical staff, as well as other environmental professionals outside the
EPA, that the traditional approach to environmental protection is inccmplete.
This approach was characterized ty the enactment o£ laws and the development
of programs and regulations that sought to control pollutants as if they
remained in the same medium into which they were initially released. The
traditional approach insufficiently recognized that pollutants cross and
recross medium boundaries, undergo chemical changes, and produce adverse
effects into media other than the one(s) to which they were initially
discharged. EPA staff have further identified five negative consequences
resulting from the traditional framework of pollution control. These
include!
o The solution to a single-pollutant, single-medium problem
might simply transfer the problem to another medium (e.g., frcm water to
air)i perhaps incurring greater risks and costs of control.
o Problems involving several environmental media may not be addressed
sufficiently by an environtiental agency that generally examines each
nedium independently.
o Policy makers have no systematic way of setting priorities across
sources, pollutants, and exposure pathways in different media. Consequently,
environmental policies and regulations may not be cost-efficient, spending
too little on some problems and too much on others.
o One-dimensional studies of pollutants and individual media may
not consider total or cumulative environmental exposure either within
a medium or across all media.
o Laws and regulations may use different and sonnet unes inconsistent
objectives, methods, and standards.
Development of EPA's current concept of integrated environmental
management began in 1981. To institutionalize this work, the Agency creat-
ed a new Integrated Environmental Management Division in its Office of
Policy Analysis. The Division, and the evolving concept, focused on
public health risks relating to toxic pollutant exposures (in contrast
to conventional pollutants) because of growing public concern over poten-
tial health effects from toxics and the fact that, .is a class, toxic pollu-
tants were less controlled. As defined by the Division, integrated environ-
mental management referred to the evaluation of control of overall public
health risks from various pollutants, pathways, and sources from a multi-media
perspective. In the view of its managers, the goal of the program was to
use existing data (and not to generate new scientific data) to compare the
costs of a proposed pollution control strategy with the risk reduction
achieved by it. They believe that the IEMP was designed principally as a
policy analysis tool that could aid senior EPA officials to set pollution
control priorities based upon relative risk across all media*
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Three key assumptions guided Division managers and staff. These
included;
o Sane public health risks are worse than others.
o Some pollution controls are more efficient than others at
reducing risks.
o Pollution control involves trade-offs among risks, economics,.
technology and other factors considered in risk rranagement.
The program methodology is essentially divided into two phases,
Ihe first phase primarily focuses on assimilation and aggregation of
available data to reach priority-setting conclusions, and the second phase
analyzes the relationship between the costs of a proposed control strategy
and the risk reduction achieved by it. AS a practical matter, roughly
90% of the IEMP'S work focuses on the first phase.
Initially, the IEMP conducted essentially two kinds of studies:
analyses of specific industries or issues, and area specific or geographic
studies. The Subcommittee notes that, since mid-1934, the emphasis
within the IEMP has shifted away from industry-wide studies and toward
issue-or probltsn-specif ie studies (sludge, hazardous wastes) that are
thought to be of interest to policy makers, and specific area studies
(Baltimore, Denver, Philadelphia and the Santa Clara Valley), Also,
during this period, the IEMP has been developing methodologies to consider
the health effects of conventional pollutants and the effects of pollution
on non-health endpoints such as crops, materials, fineries and aquatic
life. A more detailed statement of the lEMP's evolution and its current
structure can be found in Appendix A, a letter from "r. Daniel Beardsley,
Director, Regulatory Integration Division (which inci ides the IEMP), to
Dr. Ronald E. Wysga, Chairman of the Subcommittee.
Presently, the major focus of IEMP is on geographic studies, two of
which—Baltimore and the Santa Clara Valley-—have advanced to completion of
a Phase I report. The Philadelphia IEMP study has be^n released as a final
report. A fourth study, Denver, is in its initial stage of preparation.
These geographic studies provided the major input for the Subccramittee's
review of IEMP. Because the Santa Clara Valley study is the most recent
IEMP project and, thus, the study most likely to benefit frcm previous
experience in developing IEMP concepts and analyses, ~he Subcommittee places
greater emphasis upon the performance of this study i i its review. Also, the
Philadelphia study was completed at the time of this review, and no written
reports were available for the Baltimore and Denver studies. An additional
study of the Kanahwa Valley is nearing completion. Although the latter study
makes partial use of the experience and approach oi the IEMP, it is not
an IEMP study. Appendix B contains the Subcommittee1:-} separate review of
this latter study,
The Subcommittee also notes that various IEMP staff participated in
other projects within EPA during 1981-1987. These include: developing
EPA conceptual papers and primers on risk assessment and risk management;
serving as a principal source of ideas for former Administrator Ruekelshaus*
speeches; preparation of new training courses on risk assessment and risk
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cnanageraent for EPA employees. Congressional representatives, members of
the scientific eanmunity and the media; and assisting in the preparation
of an EPA study addressing the magnitude of the air toxics problem. None
of these activities v*ere reviewed by the Subcommittee.
C. Sybcownittee Review Procedures
In conducting this review, the Subcommittee met five tiroes* In 1986,
it met on April 24-25 in Washington, D« C»; July 1-2 in Philadelphia, Pa.?
September 18-19 and December 4-5 in Washington, D. C.; and in Philadelphia,
Pa. on March 16-17, 1987, .agendas for each of the meetings are included
as Appendix C. The first two meetings consisted of introductory briefings
conducted by the program staff. Curing these initial sessions, Subcommittee
members had the opportunity to develop an understanding of the origins
and expectations of the program and its subsequent development, and review
and ask questions regarding technical documents prepared in support of
the program or as program outputs. In addition, members of the public
that requested time nade brief statements to the Subcommittee of their
view of the program's direction and needs. Subsequent meetings were
devoted largely to discussion and review of technical support documents
relevant to addressing the Subcommittee's charge and the development of
draft sections of a report. The Subcommittee formed three work groups
to examine in more detail the Philadelphia, Baltimore and Santa Clara
Valley area projects and conducted site visits for the latter two projects,
on November 14 and November 21, 1986, respectively. The entire Subcommittee
participated in the review of the Draft Kanawha Valley Toxics Screening
Study.
The review is organized into two parts. The fir^t part examines
the evolving objectives of the program, and the design, implementation
and results of the geographic studies reviewed. Special attention is
given to the health scoring methodology used in most of: the projects.
Part II presents the Subconmittee's evaluation of tho specific geographic
studies.
The Subcommittee received the cooperation of the Agency staff,
both at headquarters and in its regional offices in Philadelphia and San
Francisco, as well as access to program contractors* The Subcommittee also
wishes to thank state and local officials in Philadelphia, Baltimore, the
Santa Clara Valley, and West Virginia for making avail-ibis both information
and their valuable insights on this program.
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PART ONEt
OBJECTIVES, DESIGN, IMPLEMENTATION AND
RESULTS OP PROJECTS IN THE IEMP PROCESS
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HI. THE I BMP OBJECTIVES
The general goal of IEMP, as presented in Appendix A (page 10), is to
"develop a model for local environmental management that 1) is integrated, to
the extent that it has an analytically defensible basis (quantitative? if
possible) for establishing pollution risk reduction priorities across mediai
2) takes into account both cost-effectiveness and potential for pollution
transfer in selecting pollution control remedies? 3) can be practically used
by local officials? and 4) contains an"implementation process which maximizes
the potential for broad public understanding and acceptance of management
decisions." The Subcommittee concludes that this general goal is laudable.
Limitations in the quantitative data base available to the IEMP
and the necessity of integrating data o£ questionable to excellent quality,
collected for various purposes and analyzed by technical methods of
varying degrees of sensitivity and specificity, make the development of
quantitative risk analyses extremely difficult. As demonstrated in the
geographic projects, this problem of obtaining a quantitatively reliable
data base across all areas of environmental concern is a problem basic to
multi-media risk assessment. In coping with this problem in the case of
the geographic studies (see part two of this report), SPA made certain
ccnprcmises with the result that, in many instances, the studies focused
on individual, pollutants in only one radium rather than conducting a
multi-media analysis. Neitner have all areas of significant environmental
concern been investigated. These limitations, which may be appropriate given
the resources and intent of the IEMP, are not always explicitly stated.
An evolution has occurred in the general goal and specific objectives
of IEMP as it has addressed differing envirormental t -oblens and the
varied quality of the data base in the areas studied ?;o date. For example;
o In the Philadelphia study, initial goals, not: =sll specifically
delineated in the technical support documents for thi> study, included:
1) developing and/or applying new methodologies including quantitative
risk assessment, multi-media analysis, and cost-effectiveness analysis to
analyze the effects of environmental pollutants on hunan health; 2) improv-
ing EPA decision making and priority setting through l:he use of these
methodologies; and 3) enhancing state and local decision making through
the use of these methodologies. Hence, the initial emphasis of the IEMP
appeared to be on the development and application of '"sacision making
tools in an integrated multi-media framework.
o As demonstrated by the Baltimore study, which */as directly primarily
by local officials, the development of a process for -iefining environmental
priorities, rather than scientific assessment per se, appeared to play the
major role in the apparently successful results of the Phase'I study. A
deliberate decision was made to limit general public participation in
this phase of the study. The interaction among local agencies and the
evolution of state and local cooperation in building a plausible agenda
for solving environmental problems appears to represent a major advantage
for this study, although not necessarily an initial major goal.
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o The mobilisation of ccmunity interaction was an important facet
of the Phase I Santa Clara Valley study, although the predoninant objective
appears to be the identification of potential environmental problems.
o The objectives of the recently proposed Denver IEMP study have
further evolved from the objectives of previous studies. The first
objective of this study is to "educate governments and the public on the
potential of risk-based decision making11. The second is to "encourage
local environmental professionals to gather, share, and analyze information
before considering strategies to resolve their environmental problems".
The third listed objective relates to the analysis of selected issues.
Thus, there has been a greater enphasis on process and less enphasis on
the development of analytical data, at least in the initial phases of the
proposed Denver study.
Ideally, the ability of the IEMP to develop and achieve reasonable
objectives is based on its prior experience and is consistent with the
development of a successful multi-media assessment methodology and an
environmental management program in a specific area. - In other instances,
secondary goals (whose achievement often yielded beneficial impacts)
emerged that were not part of the original project design. In addition,
sane individual projects have achieved sorae of their stated goals without
actually achieving the ultimate program goal Of developing an integrated
environmental" risk management process or [methodology* Care needs to be
taken that the integrative process does not become the major goal and the
solution of environmental problems secondary. Continual peer review of
sore type may help to forestall inconsistencies between stated or implied
objectives and development of a methodology that can support such
objectives.
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IV. PROJECT DESIGN
In general, multi-media approaches to risk assessment can introduce
more of a "systems" approach to environmental decision waking. This
approach is more likely to enable policy makers to examine the transfer
of pollutants across .media as particular control strategies 'are adopted.
This contrasts with the single pollutant-single medium methodology which
is more likely to transfer the problem from one indium to anotherr perhaps
leading to greater risks and higher abatement costs.
A strength of the IEMP project designs is the attempt to develop a
multi-media approach to environmental decision making* Clearly, the
difficulties of multi-media stadias are compounded by the fact that
data quality may vary with media; hence, the so-called "risk-based"
decision may indeed become a "best guess" decision based on an inter-
pretation of the available data. Nevertheless, if appropriately executed,
the IENP approach can represent a considerable improvement over decisions
made subjectively or on the basis of data from only a single mediuxu
Since the program is not limited to using specific models, it has the
flexibility to assess a variety of issues of particular concern to local
communities and to target data gaps and research needs. Thus, the Santa
Clara Valley study initially targeted ground water problems and the Denver
study plans to enphasize the brown cloud.
An additional element of the program is the capability it offers
to local policy makers for detecting gaps in the data base that may
become more apparent when the total data, across raedlu, are carefully
examined. With responsibility for data collection 0:1 environmental
chemical hazards related to air, water, soil, hones, \r\fj. occupational
exposures usually divided among local groups, there :
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input data using several sources, the validation of modeled outputs
through use of monitored data or even some validation o£ estifnated health
risks through the collection of clinical data.
Peer review is also one mechanism of quality control. To date, the
IEMP has developed no systematic definition or approach to peer review*
Peer review has occurred at various times in various projects for differing
issues.
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V. PROJECT IMPLEMENTATION
The implementation of the various IEMP projects varies in each geo-
graphic area, 'resulting iri both strengths and weaknesses for the prcsgrsm
as a whole. On the positive side, the program can target area-or site-
specific problems and involve community leaders, whose participation is
critical to successful implementation in developing follow-up efforts.
EPA is inevitably involved in sharing its considerable technical resources
and inforaation with communities attempting to control serious environmental
problems. Without direct access to these scientific and technical resources,
the communities1 potential to address issues raised by the IEMP would be
more limited. At the same time, the Agency is too removed geographically
frcm nsany local technical and public issues to be able to act effectively
by itself.
A noteworthy feature of implementing the program is the reliance
placed on quantitative analysis as a prerequisite to decision making and
risk management. This feature is also imparted to the constituencies
directly involved in the studies. Risk assessments peformed by the
Cancer Assessment Group are adapted to local circumstances to set management
priorities.
The weaknesses revealed in the implementation of the program may
be viewed as'mirror images of the strengths cited above. The lack of a
common approach to implementing various studies creates difficulties in
utilizing past experience or correcting technical oversights. The IEMP
program has taken several different approaches to risk assessment that,
at times, has led to insufficiently rigorous or inconsistent applications.
Specific concerns of the Subcommittee include the following:
o The definition o£ risk assessment varies acr.'^s projects. The
most widely accepted definition of risk assessment, vithin EPA and the
scientific community, is based on the four part construct developed by
the National Academy of Sciences* This construct includes: hazard
identification, dose-response assessment, exposure assessment and risk
characterization. Various IEMP projects make selective use of these four
components, but do not explain the scientific reasoning for omitting
particular components in specific projects.
o In practice, risk assessment can be used as a vehicle for making
choices Cor prediction or protection. The IMP needs to clarify this
distinction. Risk assessment for the purpose of prediction is an effort
to estimate the public health and environmental effects that may result
from anthropogenic or natural exposures to selected ropulations. As
such, risk prediction attempts to place the magnitude of the risks in
perspective with the total exposures encountered. Assessment for the
purpose of protection aims at deliberately choosing conservative assumptions
and models to protect against the probability of certain effects occurring.
While both risk prediction and protection represent statements of probability,
they rest on differing assumptions and ultimately serve different objectives.
The IEMP program should clarify its definition and use of such concepts.
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o The estimation of exposures is limited in several ways.
Considering only incremental or limited sources of exposure can result in
the failure to identify potential health problems. Methods might be
considered to examine the effects of integrated exposure through several
routes. For the analysis of health data, the IEMP has generally depended
upon peer reviewed material generated by other parts of the Agency, When
this has not been the case, however, specific acknowledgment of this fact
has often been lacking.
o As previously noted, quality control measures have been uneven with
respect to field data. Dispersion models have been applied without
adequate explanation or justification.
o The IEMP should distinguish between the value of its efforts as a
screening tool to identify and assess potential health risks and its
reliability as a technical basis foe managing risk. The level of analysis
and the requirements for expertise are very different for these two
objectives. The current IEMP process is better oriented to the first
effort, where simpler !«ethods and limited expertise are needed to help
define potential problems. The information, expertise, and tools required
to help refine risk estimates that serve as a technical basis for regulatory
decisions at either the Federal, state or local level of government are
considerably greater and, to date, IEMP has not been able to assemble and
direct the financial and personnel resources required to address the
latter effort.
o In general, uncertainties regarding the analysis of exposure,
particularly across media, have not been delineated and given sufficient
emphasis, which invites the danger that the public will place unwarranted
confidence on the analytical conclusions. This issu*; could easily be
addressed by initiating sensitivity analyses reflect ir-\ Office of Research
and Development {especially the laboratories or resea-'ch centers) or the
technical staff within the regulatory offices. The S .ibcotKiittee also urges
ORD and the program offices to more aggressively participate in IEMP activities.
The- Subcommittee has identified within EPA a number of ongoing efforts at roulti™
media risk assessment that have undergone review by the public and the scientific
ccniiiinity and that are accessible to the IEMP. These include;
1. Assessing the risks of various sludge managersnt options-^
ORD Environmental Criteria and Assessment Office (ECAO)/Office of Water,
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2. Evaluating public health and environmental in^pacts of municipal
waste conbustion--ECAQ/Qffice of Air Quality Planning and Standards (OAQPS),
3. ORD's Dotal Human Exposure (THE) program,
4. ORD's Ecological Risk Assessment research program.
5. OPQPS's multimedia evalution of lead.
Building effective working relationships with these and other
programs within EPA can achieve several important benefits for the IEMP.
These include: 1} access to and participation of scientific talent that
does not exist within the program; 2) awareness of, and access to, data
bases relevant to problems the IEMP is investigating; 3} enhanced scientific
credibility resulting from the use of data and methods that have undergone
extensive peer review.
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VI, PROJECT RESULTS
Several very different types of results have emerged front the IB€P
projects. Ihese roughly correspond to the varying objectives that were
stated at the beginning of the differing IEMP projects conducted thus
far. Phase II efforts envisage considerably more detailed analyses. To
date, however, most have not been conducted? hencef their results cannot
be evaluated. For this discussion, the Subcommittee broadly categorizes
the project results as follows;
o Interaction and comnunication among government officials,
industry and the public.
The Baltimore and Santa Clara Valley studies demonstrate that
the IEMP methodology can be a very strong catalyst for communication
between EPA and state and local officials (as in Baltimore) or among EPA,
state and local officials and the public (as in the Santa Clara Valley).
It can provide a natural forum for the routine interchange of similar
information and concerns. There is also the potential for improved
governmental and public response to emergencies and pollutant problems
that previously have not been discussed and analyzed in such a forum.
Another positive result of the IEMP is that it can provide a vehicle for
scientific experts to discuss and improve ongoing research and monitoring
programs*
The idea of having a non-adversarial forum for the exchange of
information among local governing bodies and interests is a very useful
idea* As yet untested, however, is the question of w'tether incentives or
institutional mechanisms are strong enough to ensure ;;he continuation of
this interaction among officials, industries, and th^ public once EP&
funding ends*
o Information generated and disseminated about the relative
raagnitudes of pollutant problems,
A strong feature Of the IEMP is that it provides a ccnroon metric of
risk for better understanding the magnitude of health effects associated
with widely differing sources. The importance of this feature should not
be underestimated; it facilitates communication of complex issues and
provides for a more systematic and objective basis for environmental
decisions.
However, the results presented may not be as comprehensive as perceived,
and they are subject to considerable uncertainty, The resultant "risk
meter" numbers will appear to be too authoritative and should be qualified
by uncertainty measures. For the roost part, the IEMP methodology produces
conservative upper bounds on the risks that are analyzed. Such numbers,
if they are not qualified, can be very misleading both to decision makers
and to the public. The Subcommittee strongly urges t:iat the use of the
IEMP methodology not exclude other sources of information about environ-
mental problems. For example, local data on the frequency of lead
poisioning may be more authoritative and reliable than results obtained
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exclusively through the use of the IEMP assessments. The Subqgniaittee_
concludes that the IEMF is most appropriately used when it stimulates decision_
makers at all., levels of government to ask questions and seek data concerning
the identification of the most significant public health and environmental
problems. Wot: various reasons, including limitations in data/ tine,
funds, and the current state of knowledge, previous ISMP studies have not
been as eoroprehensive as desirable. This.has resulted in the analysis of
'restricted subsets of pollutants, exposure pathways, and types of effects.
the use Of a broader and perhaps cruder, but more systematic, risk screening
would be one way to overcome these problems.
o Systematic framework for use in decision making.
The IEMP methodology addresses two current shortcomings Of contemporary
environmental decision .making at various levels of government! 1) the
need for policy makers to became more aware of the relative magnitude of
various environmental problems and the availability of alternative
regulatory and non-regulatory control strategies; and 2) the. need for the
public to perceive environmental problems with a more comprehensive and
balanced understanding and to recognize that all major activities resulting
from the use of technologies impose some degree of risk. Also, risk
assessment methodologies, once learned for one type of application, have
many other potential areas o£ application in decision making by government
or industry.
o Priorities Cor future research.
In the process of identifying environmental priorities, the IEWP is
readily adaptable as a means of identifying research -leeds. Initially,
the methodology designed to err only on the side of -.=ilse positives;
further efforts must address the possibilities o£ "false alarm" errors.
"False negatives", that is, real problems that have ot been identified
by the IEMP, can result if the application of the risK assessment approach
does not address this possibility.
In using the IBHP as a vehicle for setting priorities for future
research, special attention to these "unknowns" nust :>s given. IEMP
managers and the Office of Research and Development should develop specific
mechanisms to ensure the specific data needs identified fcy the IEMP,
or results obtained from specific projects, are integrated on a continu-
ing basis with research planning efforts carried out yy OBD.
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VII. HEALTH SCORING METHODOLOGIES
There are two overall levels of analysis in the IEMP work for developing
health scoring methodologies. These include: 1) a screening exercise under
which potential problans are identified; and 2) more detailed analyses for
evaluating risk management options. To date, efforts have been limited to
screening exercises.
A, Screening Efforts
Achieving the objective of these efforts requires a comprehensive
identification of potential concerns that are within the bounds of the
study;? hence, errors of omission are of greatest concern. Nevertheless,
the approach must be scientifically credible and as consistent as possible
with the knowledge and understanding of experts, including those in other
parts of SPA, The approach should also provide some rough indication of
the magnitude of potential problems so that raore important issues can
receive prompt attention.
Health assessment methods can be classified as those suitable for
carcinogens and those suitable for non-carcinogens*
1) Carcinogens
Risk assessment guidelines exist for carcinogens. EP&'s Carcinogen
Assessment Group and other groups within EPA have generally applied the
guidelines to estimate risks of exposures to carcinogens as a technical
basis for regulation. The assessment jtsethodology used is generally a
conservative one, providing an upper bound estimate K risk. The use of
upper bounds can lead to misinterpretation and can complicate the comparison
o£ risks of two different compounds. The risk nurobe1: estimated for a
less potent carcinogen with considerable uncertainty issociated with the
risk assessment method can be much larger than the ganparable number estimated
for a nore potent carcinogen with less uncertainty inherent in the assessment.
The Subconmittee is concerned with these issues* but it notes that other
scientific review panels, including those within the SAB that reviewed
the cancer guidelines, have concluded that, at present, we can only have
confidence in the plausible upper limit calculated using the methods
described in the EPA's Guidelines for Carcinogen Risk Assessment. Procedures
for making "most likely" or "best" estimates with the range of uncertainty
defined by the plausible upper limit estiinate and the lower limit estiinate
(which may be as low as zero) should be important goals for risk assessment
research at EPA.
The preparation of specific risk assessments requires significant
judgment about the choice and interpretation of input data and the specific
analyses of these data. This is evidenced by the considerable discussion
supporting the analyses undertaken in most of the Health Assessment
Documents developed by the Office of Research and Development, Those
risk assessments developed within the Carcinogen Assessment Group (CAG)
generally receive extensive review by many experts within and outside the
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agency, including the SAB. Hence, the risk estimates produced by the CAG
have the credibility that derives from a widely reviewed and consensus-based
methodology and an application of the methodology that receives additional
review. CSG estimates should, therefore, be used to estimate carcinogen
risks when such estimates are available. In some cases, it may be appropriate
for the IEWP to review the basis for the CfG estimates and examine the
sensitivity to specific assumptions in determining the numerical results.
When this is undertaken, it should be explicitly stated to avoid confounding
results based on different levels of review.
Occasionally, there may be some evidence that a substance is a
carcinogen, yet its risk has not been estimated by CAG. In such cases,
the presence of this substance could be noted by the IEMP as a sort of
"yellow flag" warning* When bioassay results are available, it nay be
appropriate to calculate a quantitative risk estimate using a roethodology
consistent with EPA's Guidelines for Carcinogen Risk Assessment. In the
absence of internal review by EPA staff and external peer review, such
estimates should be clearly identified as speculative, and their use
should be restricted to "what-if" investigations to assess the potential
magnitude of the health risk posed by the substance in question. Careful
qualifying language should be used to discourage readers from roisin-
terpretating these estimates as having the same level of credibility
as the peer reviewed estimates from CM3, and to discourage the use of these
estimates by EPA or other regulatory agencies at the Federal, state, or
local level for regulatory decision making. The extensive caveats used
with the risk, estimates for TCA in the Santa Clara Valley IEMP Phase I
report represent the type of careful description needed when such speculative
estimates are used. Nevertheless, some peer review of such independently
derived risk estimates would be desirable.
2) Non-Carcinogens
Evaluating non-carcinogen issues is n»re difficult because there
ace, at present, no guidelines for quantitative risk assessment for
non-carcinogens, although such guidelines are currently under development
by several groups. There also does not appear to be i clear consensus on
the appropriate role of quantitative risk assessment tar these agents*
Recently, the Agency has introduced the concept o£ a Reference
Dose (RfD). This is an implicity safe level below which effects are not
expected, although its definition appears to be largely in tents of the
procedure used to calculate it. Reference doses, or 'in equivalent such
as an Acceptable Daily Intake (ADI), have been calculated by several
Agency offices as a scientific prelude to regulation -\nd/or policy develop-
ment. These calculations have followed the traditional practice of using
a ao-observed-adverse-effacts-*level (NQAEL) froro animL studies and
dividing by a safety factor of 10, 100, or 1,000 in order to estimate a
level at which human exposure becomes a concern, ADI and RfD levels
have generally received extensive peer review. The methods involved to
calculate the RfD are well delineated, but substantial interpretation of
the underlying data is usually required. The IEMP uses the RfD in its
screening efforts; when estimated exposures exceed the RfD, the estimated
number of individuals exceeding the RfD is identified. Often potential
or even identified toxics are encountered for which no RfD exists. In
these cases, the IEMP has applied the methods used to calculate the RfD
to the underlying toxicity data to estimate the "lowest presumed human
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threshold." This value is used in the analysis as the RfD would be used.
The calculation of this value may depend quite critically on1 judgment? in
addition to the toxicity data* Given the different levels of peer review
associated with RfDs, it is important that those derived within an IEMP
project be clearly identified and caveated.
The use of the RfD alone, without an estimate of response above this
level, does not address some potentially important issues such as the severity
of impact and the number of people likely to respond to the environmental
level of the agent. Individual or population response depends upon both
the environmental level of the agent and upon the shape of the dose-response
curve. Hie IEMP has developed a method to represent the dose-response
relationship and has asked the Subcommittee to review? it. The IEMP has
noted seme exainples when application of the method would change the
relative priority given to various issues.
The Subcommittee has reviewed the method, and in general, concludes
that the IEMP should stimulate the Agency as a whole to consider such
methods, among others, in the further development Of risk assessment
guidelines and procedures. The evaluation of a method, however, recjuires
an in-depth assessment of its repeated application. The Subcommittee recom-
mends, therefore, that EPA's Risk Assessment Forum undertake this effort,
present its analysis for peer review and publish its results.
At this time, the Subcommittee believes IBMP's main emphasis should
be on the RfD. In its screening effort, the ISHP should identify the
number of individuals exposed to levels at or above the RfD. Where
significant numbers of individuals may be exposed above the RfD, further
analysis of the severity of the impact and the close-"isponse relationship
will be appropriate.
3. More Detailed Studies
These studies require considerably more detailed information and
greater precision in risk estimates to help guide risk management policies.
Accordingly, some modification of the IEMP methods i-s warranted. One
advantage of these studies is that they are inore narrowly focused, and
attention may be concentrated on a small number of toxic substances to
aid risk management decisions. Because considerably more detailed
scientific input is required in these studies, peer review mechanisms
need to be an integral part of these efforts.
1) Carcinogens
The EPA Guidelines for Carcinogen Risk Assessment provide for the
flexibile use of available scientific information for quantitative risk
assessment, and the Subcommittee encourages development of procedures for
making "most likely" or "best" estimates, as opposed to the plausible upper
bound estimates calculated using EPA's standard methodology. Innovation
in carrying out detailed quantitative risk estimates for specific carcinogens
should receive peer review, and such estimates should be acccnpanied by
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extensive sensitivity analysis* The sources of uncertainty in the risk
estimate should be clearly identified and discussed. The methods used
for the risk estimates should be fully documented and summarized in non-
technical language so that the basis for the calculation is readily
accessible to all interested parties.
2) Non-Carcinogens
The state of the art of quantitative risk assessment is not as far
advanced for other health endpoints as It is for carcinogens. When it is
clear that a significant number of people are exposed in the ambient
environment above the RfD level for a toxic substance, further analysis
may be needed as a technical basis for risk management. The Subeoimittee
supports the development of appropriate methods to carry out such an analysisr
drawing upon the scientific and analytical resources available in the
Office of Policy, Planning and Evaluation, the Office of Research and
Development, and other parts of EPA. Such an analysis should receive careful
scientific peer review, especially icrtiere innovative methods are used,
For many substances, the severity of the impacts may be a major issue as,
for example, distinguishing between clinically measurable effects that
are rapidly and completely reversible at lew levels of exposure, versus
irreversible -impacts representing clearly significant adverse changes in
health status that may occur with higher or repeated exposures. It will
be appropriate to document fully the methods used to carry out extensive
sensitivity analysis shewing hew conclusions depend on specific data and
assunptions, and to describe the extent and sources of uncertainty in the
quantitative risk estimates*
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PART TWOs
THE PHILADELPHIA, BALTIMORE, SANTA ClARA VALLEY AND DENVER
GEOGRAPHIC PROJECTS
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VIII. PHILADELPHIA INTEGRATED ENVIIOM^ENTAL MANAGEMHCT PROJECT*
A. Overview of the Project
The Philadelphia IEMP- was a large-scale stuay of the effect of
toxic pollutants on human health in the Philadelphia metropolitan area.
Although the study had a number of goals, not all of them clearly
delineated, the three roost important goals included: 1) developing and
applying new methodologies or applying existing methodologies to new
situations-Tparticularly quantitative risk assessment, multi-media analysis,
and cost-effectiveness analysis; 2) improving EPA decision making and
priority setting through the use of these methodologies; and 3) improving
state and local decision making through the use of these methodologies.
phase I of the Philadelphia IEMP identified eleven issues to
pursue in Phase II. These related to chlorinated solvents, benzene,
chloroform, formaldehyde and volatile organic compounds in general.
Phase II involved risk and control-option analyses of seven of these
issues and also proposed to collect monitoring data on four issues;
benzene emissions, formaldehyde releases to ambient air, combustion of
used oil and air emissions from landfills.
B. Comparison with Other IEMP Studies
Philadelphia was the Eirst of the geographic IEMP Studies. In
terms of institutional arrangements, EPA, state, and local officials
vwrked together to direct the project, although the dominant role was
played by EPA. This contrasts with later studies in ^hich EPA yielded
more decision making authority to state and local otzicials.
C, Comments by Interested Parties
The Subcommittee heard testimony from state and local officials
involved in the Philadelphia IEMP, The general tone of these ccnwents
was negative. The officials viewed the study as having made their duties
more difficult by unduly alaming the public about is-sues that involved
some greater-than^zero risk o£ cancer but that, in th-j view of these
officials, did not represent a high public health priority. An industry
spokesman testified that the study should have used bost estimate risk
assessments rather than the standard EPA worst case i-ethodology. No
views from environmentalists or other groups were heard by the Subcommittee
on this study.
D. Subcommittee Cements
• The Philadelphia IEMP study has only partially met its goals.
The three goals included;
. o Methodology Development and Application
The underlying methodological innovation of the project was to
analyse environmental priorities (and potential control actions} on the
* Subcommittee members contributing to this section of the report included
Dr. Cornish, Dr. Davies, Dr» McMichael, and Dr. Frank.
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basis of overall risk regardless of the medium or form of the risk. This
is a significant departure fron current practice (at both the Federal and
local level) and, in the qpinion o£ the Subcommittee, is a very important
and useful innovation, it is, in fact, the most important methodological
contribution made by the IEMP as a whole. It should also be noted that
the development of such a risk-based methodology is a very difficult
intellectual and scientific task,
The application of quantitative risk assessment in the Philadelphia
project involved the use of a health scoring methodology that the Subcommittee
closely examined. The risk assessment results showed small cancer risks
from toxics in ambient air (an upper-bound estimate of about 0.2 excess
annual cancers from both point and area air sources) and a larger, but
still modest, risk from drinking water (2.4 cases annually). However, it
should be kept in mind that these results excluded seme potentially
significant sources of toxics, notably motor vehicles and municipal
incinerators. Given the lack of comprehensiveness in the analysis of
sources, the risk assessment is primarily useful as a way o£ assessing
the comparative importance of particular sources rather than of the
inportance of the toxics problan generally.
The lack of comprehensiveness was primarily due to the limits on
resources available to the study and to a recognition by the staff on
what could be achieved. It was aggravated by the failure of some of the
lEMP's efforts to collect original data using novel or state-of-the-art
techniques. Four such efforts were part of the Philadelphia projects
benzene and formaldehyde in the ambient air, air emissions from landfills,
and combustion of used oil. The benzene data indicated that ambient
benzene levels were within ambient air guidelines, but the small number
of samples and the high degree of variability of observed concentrations
limit the reliability of the data. The use of models to predict ambient
concentrations of formaldehyde failed because of for:-aldehyde formation
in the atmosphere through photo-oxidation of volatil * organic compounds
(VOC). Ambient levels of fotmaldehyde derived from >.-onitoring appeared
to be below guideline levels, but doubt has been cast on the analytical
method employed in the monitoring program (see page TV-14 of the Philadelphia
study), A variety of difficulties with the experimental ROSE system result-
ed in a failure to uneasure the contributions of a landfill to ambient WJC
levels, although data obtained on VDC levels in the sj-aneral vicinity of
the landfill contributed to a concern over toxic air emissions frcro land-
fills. The data on combustion of used oil were not sufficient to allow
exposure or risk assessment (IV-22), although analysis of samples of used
oil indicate that the lead content of used oil is a ;otentially significant
problem (IV-25),
o Impact Upon EPA Decision Making
The impact of the Philadelphia study upon EPA is difficult to ascertain.
The study set SCOTS important precedents for the later geographic studies
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(e.g., the basic Phase I - Phase II framework and the idea of bringing
local officials into decision making), it also can be argued that the
Philadelphia,study encouraged EPA to think in terras of overall corparative
risk as the basis for setting priorities.
The Philadelphia project resulted in bringing two specific problems
to SPA's attention—the contribution of municipal wastewater treatment
plants to VDG air pollution and the problem of lead in used motor oil.
EPA has taken no final action on either problem, although National Pollution
Discharge Elimination Systsn (NPDES) permits for treatment plants increasingly
take the WC problem into account. In addition, it can be argued that
the relatively low risks attributed by the project to toxics concentrations
in ambient air and water confirm an Agency view of the lack of urgency of
the toxics problem in this area.
o Impact Upon State and Local Decision Making
As noted above, state and local officials did not think that the
project has been particularly useful to thgn. However, the IEMP staff
reported that, in private conversations with Philadelphia area officials,
the latter expressed the view that the study yielded a deeper awareness of
the problems posed by the inter—media transfer of pollutants, prompted a
continuing informal cooperation among these officials and HPA and contributed
to the effort by certain inctustries to pretreat their wastes in advance
of impending Clean Water Act regulations requiring pretreatment* The
Philadelphia study (VI-44) notes that the chemical manufacturer that was
the prime source of VOC discharges to the Philadelphia treatment plant
has markedly reduced its discharges, although it is not clear whether
action can be traced to the IMP study. There may b>? a greater knowledge
of and sophistication about risk assessment and cost-effective analysis
at the local level as result of the IEMP project, taut it is not clear
that the project has had any lasting impact on state or local decision
makers.
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IX. BALTIMORE INTEGRATED ENVIFONMENTAL MANAGEMENT PROJECT*
A. Overview of the Project
The Baltimore project began in pilot form in 1983 under full
EPA control. In 1983, EPA delegated this control of the project to two
local committeesi a Management Committee and a Technical Advisory Ccmmittee.
A great deal of the effort expended in the Baltimore project from
its inception seems to have revolved around issues related to the governance
and control of the project, setting the scope of the project, identification
of specific issues and compilation of data. Resolving issues related to
project management and control required an intensive effort such that the
project was actually started twice, the first time in the fall of 1983
and the second time in late 1984, In the process, there were considerable
changes in personnel, and major shifts in contractors that were developing
information for the project.
Plans for Phase II of: the Bait wore study are to conduct more detailed
evaluations of issues that have been identified as particularly critical
in Phase I, and to institute pollution control measures, where needed.
The Phase II process is less well defined that Phase I, largely because
it focuses on site-specific issues and because of unresolved questions on
the funding of implementation plans.
B* Comparison with other IEMP studies
There are many features of this study that differentiate it from the
other geographic studies. The Baltimore IEMP has processed from an EPA
designed study to one that is enriched by state, cou-icy, and local inputs
concerning potential and actual toxic pollution problems* A statement
frequently used during a visit by a workgroup of the ^ubcommittee was the
assumption of local control in the context of an experiment in environmental
management. In contrast to the Philadelphia study, there is a high
degree of local confidence in the approach being iinplanented in Baltimore.
The level of local control in this study is atypical of IEMP studies, and
it is planned that future studies will not follow thi-5 approach, but one
similar to the Santa Clara Valley study.
The Baltimore Management Committee provides a vital link to ensure
progress in the overall development of the project and has worked closely
with the Technical Advisory Committee (consisting of scientists from
local governmental agencies and universities) to develop a set of priorities
in Phase I. The six identified issues are presently neing finalized for
examination in Phase II. In contrast to some other I->1P projects, the
Phase II activities primarily will include further research rather than
the implementation of management decisions based upon weak exposure and
risk data, A commendable feature of the Management Committee deliberations
has been its determination to develop the program at its own pace, and
not be driven by externally imposed milestones. This has provided the
Baltimore IEMP study with the time necessary to ensure that the priorities
* Subcommittee members contributing to this section of the report included:
Or. Brown, Dr. Kartung, Dr. Lioyf and Dr, Silbergeld.
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for Phase II are the most important, and will be able to proceed with a
degree of scientific and engineering rigor.
Mother' departure from the other IEMP studies has been the Manage-
ment Committee decision to establish a standing Technical Advisory Conmittee
to oversee the Phase II analyses. The peer reviewers' role will include
assessment of the uncertainties, the methods of expressing risk, and the
health significance of the risk numbers. This additional corroittee has
the potential for making significant contributions to the study, and its role
should be revisited at a future date to assess its success within the
overall IMP process.
One of the impressive aspects of the Baltimore IHMP study stems from
the selection of the final six priority issues after discussions were
held on over forty potential issues. Further, the final list of priority
issues would be considerably different if the Management Committee had
been required to make hastier decisions. Again, this points to a thoughtful
approach to the decision making process, and the need to digest information
available frcm a number ot sources.
Another aspect of the Baltimore study that is different frcm all
other IEMP studies is the manner in which local committees used the
health scoring methodology. The results of the methodology did not
determine the final prioritization of issues. Local experience and data
on exposures, morbidity, and mortality were used in making the final
selections. The result was the identification of at least two issues,
indoor air pollution and lead, for inclusion in the final list that would
not have necessarily been included otherwise. This >vproach to applying
the health scoring methodology underscores the need '-. :> view Phase I as a
serai-quantitative exercise, and avoid the tenptation to count bodies,
e.g. as in the Philadelphia and Santa Clara studies,
C. Evaluation by EPA's Program Evaluation Division
A major conclusion of an internal EPA review of the study by the
Program Evaluation Division was that the integrated environmental manage-
ment concept is basically a rational approach to environmental protection
which deserves a fair trial and possible application in some form*
However, in practice, there are many technical, institutional and managerial
issues that provide some reconsideration as to whether the IEMP approach
is workable in practice.
On the technical side, the limited availability of data and the
limitations in the scientific underpinnings make it nifficult to establish
reasonable estimates of risks for exposure resulting frcm multiple chemicals
by.multiple routes arising through multiple media.
Institutional and managerial problems include jurisdictiona! disputes
and the public debates concerning politically unappealing issues in
election years. The management of the project in the face of conflicting
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interests and insecure sources of funding for the investigation of
environmental problems (that are often coupled to rt»re secure sources of
funding for any remedial measures that might be proposed), is an extremely
difficult preposition.
In general, the Program Evaluation Division concluded that the
IMP process is still in an evolutionary stage, that the basic concepts
within the IIMP approach are sound, but that the scientific and technical
basis for executing the program is weak.
D. Comments by Interested Parties
As with other IMP studies, the Subcommittee sought out opinions
frcm persons who had directly observed or participated in the study and
had formed impressions or judgments of its strengths and deficiencies.
In Baltimore, most of the potentially interested parties have received
some chance to participate, either through its Management Ccmmittee or
the Technical Advisory Committee, The latter also provided access to the
IEMP of additional consultants from government, industry, public interest
organizations and universities. However, neither industry nor public
interest groups influenced the Phase I efforts significantly* their
inputs will be somewhat rnoce vigorously sought in Phase II, according to
the Management Committee. Finally, both committees had the benefit of
further peer review by a Risk Assessment Review Panel assembled by the
Johns Hopkins School of Public Health,
To solicit the views of interested parties, the Subcommittee and
IEMP staff arranged for a subgroup of the Subcomnittv'e to meet with
persons especially knowledgeable about the Baltimor-- project. That group
included all the official members of the Management '.'onmitteef the Chairman
of the Technical Advisory Ccnmittee, some consultants to the project, and
members of the EPA staff for the Baltimore project.
The subgroup heard a clear message to the effect that, in Phase 1 of
the Baltimore IEMP, process was more important than science in determining
its direction. The majority of the participants, if lot all of them,
appeared to view this situation as a great virtue o£ the Baltimore project
in comparison with other IMP Studies. They seemed r.o view the difficulties
of the Philadelphia project as largely attributable to a lack, of attention
to process. Although the Subcommittee recognizes th.^t the participants,
by being at the core of this process, may tend to inflate its virtues,
there is no doubt that at least this group believed ^.he project to be a
success because of process, not through any exclusive virtues of the IMP
itself.
The participants also believed that the issues selected for study or
action in Phase II deserved attention, and that the process of arriving
at those choices enabled a much greater opportunity tor intergovernmental
exchange of information and coordinated action on environmental problems
than had previously existed* The interactions occur .ring through the
management and technical committees, for example, made it possible for
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state, county, and city officials to agree on a course of action to
lessen the risks of lead by banning it in solders used in construction
throyghout the Baltimore area.
Less definite was whether the !£MP itself was the reason for the
success or merely a convenient mechanism for intergovernmental cooperation.
Local officials were skeptical about the risk assessment process and were
not eager to use it as a dominant tool in selecting Phase II issues. In
fact, the IEMP approach played only a support role in clarifying comparative
risks f not for identifying the hazards of greatest concern. One participant
said, in effect, that the project had produced no surprises, that local
envirormental agencies knew more about Baltimore's problems than EPA
headquarters could hope to identify* Nevertheless, when asked whether
any other EPA program might have had equal effect if control had been
released to local officials, he stated no. The consensus o£ local opinion
is that the discipline of attempting to adopt a multi-media perspective
was useful, even though most problems turned out to be dcrainantly in one
nedia? the risk analysis framework was an interesting and potentially
valuable concept! and the fnultiple-criteria decision approach was appropriate
for Baltimore's needs.
Another virtue of the IH^P process for local participants was the
opportunity to benefit, scientifically and financially, from other EPA
programs, Baltimore's envirormental agencies were able to use the IBMP
experience to work with EPA's Office of Research and Development in its
decision to conduct a Total Exposure Assessment Methodology' (TEAM) study in
their region. This work will consider human exposure to toxic substances
through several routes, including indoor air. Baltimore will thus gain a
more sophisticated profile of the distribution of exposures from various
sources in its environment, with Federal support, otner EPA offices will
also contribute efforts to help Baltimore character i?:e its environmental
problems*
Particularly iinportant from these participants' vantage point was
the ability of the local governments to control how the results of the
IEMP were to be coranunicated to the public. They believed that other IEMP
studies had erred in presenting body counts of predicted numbers of cancer
deaths, even with many qualifying phrases (although they did emphasize the
importance of careful qualification of any results). Because the Subcdtmittee
has not seen the Phase I Baltimore project report, it is not yet clear how
the results will, in fact, be presented, but it seems likely that it will
not state many purely quantitative results capable of easy misinterpretation.
final observation should be mentioned. The participants seemed
to think that little truly scientific work had occurred in Phase I, even
though EPA and its contractors had undertaken several data collection and
processing efforts on behalf of the Baltimore project leadership. Some
of the analyses seemed to have had the effect of confirming preconceptions
about the rest important environmental issues in Baltimore, rather than
identifying new issues or discounting the preconceptions. The participants
seemed confident that more influence from scientific analyses would be
expressed in Phase II.
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S. Subcommittee Evaluation of the Baltimore IBMP Study1
1) Sccpe of the Project
The Baltimore IMP study exceeds in scope other geographic projects
by including indoor air pollution as a candidate issue and several issues
not exclusively concerned with human health. Both of these expansions
are well within the spirit and capability of the IEMP concept and are
valuable additions. The Baltimore project, like other IEMP studies,
avoids occupational hazards and the risks of sudden environmental events
such as an upset at a chemical plant, while sane would argue that such
considerations are logically part of an overall strategy for environmental
inanageraent, they are clearly at the fringes of the area of potential
study topics,
In general, the Baltimore project meets or exceeds the requirements
for an integrated management study. Viewed frcm one perspective the process
for identifying issues used in Baltimore was less systanatic than desirable
from the 1EHP perspective and could have missed, or assigned inprqper
priorities to, important issues. Relying as it did on ncminations from
Technical Advisory Ccnroittee members and on selection procedures that
were influenced by personal evaluations, the Baltimore project could have
enphasized visible or scientifically interesting issues over ones with
greater local importance. On the other hand, by relying upon individuals
with considerable expertise and experience with local problems this process
may have minimized the expenditure of tiji&e and other resources on peripheral
problem. Both local committees are convinced that the process was better
at selecting the truly important issues precisely because it included
expert judgment rather than relying on a narrower sn..>R assessment concept
for priority setting,
2) Project Design
Without a final Phase I report, the Subcommittee cannot fully evaluate
the quality of the Baltimore project design. Its information originates
from EFA's Program Evaluation Division report and ot'ier documents made
available by the IEMP staff, and frem the meeting with representatives
of the two local coronittees. As can be inferred fron statements elsewhere
in this section, the Subcommittee is not fully comfortable with the apparently
high degree of reliance on informed opinion in the process of selecting
high priority issues. Furthermore, although the analyses of specific
classes of issues appears to be logical, the Subcommittee has no docu-
mentation to confirm this impression. Finally, the .Subcommittee believes
that a clear analysis may have been obscured by the tendency to make
multiple classifications of issues into incomnensurable and overlapping
classes. For example, the three Technical Advisory Committee subcommittees
were concerned with human health (an environmental hazard endpoint),
ground water (an environmental medium), and ecological impact (another
environmental endpoint). It is not clear from the material presented how
the classification by risk and uncertainty was used in selecting issues and
whether that use was logical* Presumably, issues of high risk and low
uncertainty are candidates for risk management actions, while issues of
high or moderate risk and high uncertainty are candidates for further
study.
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Offsetting the above apparent or real shortcomings in the project
design is the obvious advantage of utilizing local personnel acid their
familiarity .with Baltimore's environmental problems. Most observers in
EPA, as well' as in Baltimore, new appear to believe that the qualitative
inputs from local environmental professionals arrived at a better final
list of issues for Phase II than would have been possible by applying the
method for risk assessment of human health hazards used in Philadelphia
and the Santa Clara Valley. Perhaps the balance between these strengths
and weaknesses will become more apparent once the Phase I report is
released.
3) Degree of Integration
The discussion of multi-media integration within the Baltimore IEMP
study reveals some difficulties. The medium-specific regulatory demands
placed upon the states increases the difficulty of allocating resources
to examine multi-media issues on a continuing basis* The degree to which
the IEMP can institutionalise multi-media analysis requires more thought,
since it is not readily apparent in those projects reviewed by the Subcom-
roittee. It should also be recognized that it is BPA's plan to turn the
process over to the state, and it is not clear that an integrated environ-
mental planning process currently exists.
4) Project Execution and Achievements
The Baltimore IEMP is not close to completion and, therefore, it is
ijtipossible for the Subcommittee to assess the final results. Some obser-
vations are warranted, however, to provide sane per:;L^ctive on the potential
for success.
The IEWP approach led to the generation o£ many useful hypotheses
about health and environmental problems in the Baltimore area. Although
anecdotal documentation exists on inter-media transfers of pollution,
neither the prevalence nor the magnitude of such events had beea previously
investigated and documented. The IEMP approach in Baltimore is logical
in that it seeks to identify environmental problems in all media simultan-
eously, to prioritize than, and to construct an optical approach for the
mitigation of these problems. It does this by evaluating the potential
exposures and resulting risks to humans arising fron all media.
The evaluation of potential exposures is largeI/ based upon the data
which are readily accessible in large data banks. A weakness in these
data is that they were often collected Cor purposes other than exposure
estimation. In the early phase of the project in 19.33, while it was
still fully under the control of the EPA/IMP r there was a modest sampling
program designed to identify selected volatile organic compounds in air,
In spite of this effort, the previous evaluation committee still believed
that the data base was relatively sparse, considering the broad range of
intermedia issues which needed to be dealt with, ana recommended that the
data base and the guidelines for their use should be unproved.
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The fact that most management decisions are being delayed until
after the ccnpletion of Phase II is a positive sign, and this caution
should increase the likelihood of succeeding in many areas. The approaches
used to address the six priority issues have differentf but identifiable,
endpoints" that can be used to make management decisions. Each issue and
approach are briefly stated below:
o Indoor air poUution--ccfflpletion of a TEAM study by 2PA's Office of
Research and Development and the IBMP*
o Ambient air toxics—identification ot sources and development of a
regulatory program.
o Underground storage tanks—development of engineering solutions to
leakage problems.
o Lead—abatement strategies for painting, and lead pipe replacement.
o Baltimore harbor—development of a practical design to study the
harbor with eventual state funding of a study.
o Trihalomethanes—using national approaches to solving the problem.
5) Strengths and Weaknesses
How does the Baltimore IQflP study cai^are with the profile of strengths
and deficiencies that the Subcommittee sees in the IEMP program as a
whole? It may be too early to answer this question, in that no final
report from Phase I is yet available. The remarks X>low mist necessarily
reflect preliminary observations on the direction of the project.
In many ways, the Baltimore project portrays a I lost the exact opposite
profile seen in roost IEMP projects. It is much more traditional in that
it uses consensus building to identify the major issues rather than
apply a consistent yet incomplete risk-driven assessment. Consequently,
it has the virtues and flaws of that approach. These includes
o Taking into consideration a wide variety of ddditudinal and
impressionistic as well as scientific factors. Human perceptions of risk
are considered to be important and not necessarily just a misreading of
"true" risks.
o Processing information of many kinds that cannot easily be
placed in a quantitative frattiework.
o Viewing local interests as a positive influence on decision
making, not as an impediment to clear quantitative thinking, and taking
advantage of the political process rather than avoiding it.
o Seeming, at least through Phase I, to avoid relying on risk
assessment methods that ace easily challenged as unreliable and uncertain.
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o Including environmental problems that have few, if any, human
health hazards, yet may be important for non-human organisms or for the
physical environment.
o Featuring a peer review process designed to identify scientific
weaknesses.
a Suffering trcm lack of scientific demonstration that the issues
selected for future work are, in any absolute sense, the most iiriportant
ones. It • is not clear that these issues would rank at the top of
Baltimore's environmental problems if ranked on health risk, either
collective or individual.
o The decision maKirig process rnay be raore vulnerable to influence
by a strong individual or agency that may have a different agenda than
that which is in the best environmental interests of the whole ccrminity,
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X. THE SANTA CLARA VALLEY STUDY*
A. Qvecvi0rf of the Project
The IBMP, as demonstrated through the Santa Clara Valley study,
represents an effort to create an innovative process of integrated
environmental management and education. The task of Phase I of the study
was to identify and compare potential human health risks attributable to
various pollutants, sources, and exposure pathways. The results of phase
I are to assist Federal, state and local governmental officials, as well
as firms and individuals, in setting research and regulatory priorities.
Phase I was also designed to identify pollutants, sources, and exposure
pathways for which limited data exist.
An important goal of the study, as viewed by the IEMP staff, has
been to integrate scientific information and public policy making and to
improve public comprehension of acceptable risk. The study, according to
the IEMP staff, would be considered successful if it created a "legacy of
an environmental management process." According to the involved parties,
however, the structure of, the integrated envirormental management process
in the Santa Clara Valley is still very fragile.
The IEMP has helped to reduce public conflict between the different
Organizations and increase understanding of the capabilities and limitations
of each organization. Thus, the IEMP has contributed to improved com-
munication among members of the community organizations and encouraged.
them to share information and resources* The IEMP also encouraged a
public realization that there is a ccnraunity responsibility regarding the
toxic waste problem.
B. General Review Comments
The methodological aspects of the Santa Clara Valley study are
relatively simple and approximate; this is cccnjnensurate with the objectives
of a screening study. The study uses numerous simplifying assumptions,
roost of which overestimate the risks. Under this approach, most potential
problems (with the exceptions noted in Section 3) could be identified* it
is also possible that many less serious problems could be identified in
the preliminary contaminant screening process.
The Subcommittee's greatest concern with the study occurs at the
point when it goes beyond the screening efforts of Pnase I. For the roost
part, Phase I identifies problems determined by upper bound analyses that
are subject to considerable uncertainty. The uncertainties occur principally
in the areas of exposure and toxicity (potency). It is important that
these two factors should be neither underestimated nor grossly overestimated
prior to analyzing risk management options. Therefore, the uncertainties
associated with exposure and toxicity estimates should be clearly identified
and, to the extent possible, quantified as soon as possible in the course
of the Phase II work.
* Subcommittee members contributing to this section of the report
included Dr, Cohen, Dr, North and Dr. Wyzga.
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Making appropriate risk management decisions and setting research
priorities (as in Phase II) can only be accomplished with foresight of
the type and; magnitude of uncertainties involved in the risk assessment
process. TWese efforts require more sophisticated tools than those
employed in the Phase I study.
£j0cal authorities appear to take the study results regarding health
risks literally. For example, the screening results of Phase I were
misinterpreted by several members of the Public Advisory and.Intergovern-
mental Coordinating Committees. These persons implied that potential
effects (presumably upper bounds) were best estimates. Therefore, more
care is needed in presenting as well as in deriving results.
C. Sources and Contaminant Selection
One of the important objectives of the project was "to evaluate
and compare the health risks...from toxic pollutants in the environment."
Given this objective, the consideration of sources may be too limited
because the pollutants considered, and their sources, are largely based
upon incomplete data bases from a single medium. A truly integrated study
needs to go further and ensure that all relevant pollutants are considered.
The study made a reasonable effort in its initial compilation of chemicals;
some, however, were dropped from further consideration due to lack of
existing monitoring data. Further monitoring efforts may be advisable
in, or prior to, Phase II to ascertain whether these chemicals are present.
Consideration might also be given, in or prior to Phase II, to the trans-
formation products of seme of the chemicals initially identified.
One way of testing the comprehensiveness of sources is to examine
exposures predicted from source levels and to compare these with monitored
concentration levels. Discrepancies could indicate poor source inventory
or less than adequate modeling. The discrepancy not-.^d for benzene, for
example, may be a clue that source estiisates for organics emitted to the
air are low. The study also assumed that chlorinated hydrocarbons do not
degrade, despite strong evidence that 1,1,-DCE and vinyl chloride were
detected where no likely sources were identified. The rationale for and
implications of this assumption should be clarifiecu This suggests that
comparisons of exposure monitoring and modeling should be undertaken in,
or prior, to Phase II. Finallyf source-receptor modeling is a viable
procedure that should be been taken to assess the significance of various
sources in relation to Phase II.
D. Contaninant Transport
1) Ground water
The Phase I analysis assumes that the major clay confining layer is
impermeable and that contaminants can move past this layer through conduit
wells. This assumption relies on: 1) limited monitoring data indicating
that contaminants have not yet reached the lower aquifer through the clay
layer, and 2) on judgments of individuals consulted by the project managers.
Hence, the study suggests that ground water contamination is limited to
the upper aquifer. The study does state, however, that cracks or fissures
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in the confining layer separating the upper and lower aquifer can lead to
a significant exchange of pollutants between the two zones.' Yet, an
analysis th$t considers possible contaminant migration through cracks and
fissures in {the clay layer was not considered in Phase I. Consequently,
quantitativefestimates of the time scale for future contamination of the
lower aquifer have not been provided. The above deficiency has been
recognized in the Phase I report and a recommendation has been made to
reexamine the effectiveness of the clay layer in protecting the lower
aquifer (Phase I study, chapter 4, page 92).
The Phase I analysis assumes that the dispersion coefficient in the
Santa Clara Valley is similar to aquifers elsewhere. Furthernore,
retardation factors for the Palo Alto Baylands have been applied to all
the hydrologic zones except the southeast recharge zone* Uncertainties
in model prediction associated with the above assumptions, and their
effect on the risk analysis, have not been clearly addressed. There is a
need to provide better documentation of the various scientific assumptions
and models utilized in reaching the conclusions regarding the degree of
ground water contanination.
Ground water contaminant transport models employed by the IEMP are
generic rather than site-specific. Since ground water contamination
problems are site-specific and require detailed hydrological character-
ization in order that contaminant migration be assessed, it is unlikely
that generic modeling can lead to more than a very crude assessment of
the level of current or future ground water contamination.
The analysis of future risks from ground water ;;ontamination is the
roost uncertain part of the Phase I analysis. In £ae",» it is unclear
whether future contamination resulting from continui.ig contaminant plume
migration is likely to be higher or lower than the current estimates.
Thus, conclusions to date may be incorrect.
2) Mr Contaminants
The characterization of metals and organic particulates was based on
rough estimates of emissions from a partial accounting of a variety of
plausible sources. The area sources were scaled to the Santa Clara
Valley based on information available in the national literature, while
point sources were estimated based on preliminary source testing. The
estimates of ambient concentrations for particulate organics and metals
have not been conf ioned by modeling of the emission estimates. Moreover,
detailed source estimates specific to the region haw not been carried
out. Some of the above deficiencies are being addressed by Phase II of
the study.
In the analysis of organic particulates, the study assumes that
data on Benzo(a)Pyrene concentrations from other cities can be applied
to the Santa Clara Valley. Although it may be logical to scale emission
rates based on data for other regions, the assumption of equivalent
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concentration levels roay be a gross oversimplification. The concentration
of B(a}P in the atmosphere greatly depends on the rate of atmospheric dry
deposition in the region as well as the effect of rain scavenging during
rainy periods. It would have been more appropriate to estimate the
concentrations of organic particulates based on multi-media transport
models driven by estimates of sources in the area. The second assumption
employed was that the ratios of total suspended particulates to polyarcctiatie
hydrocarbons from other cities can be applied to the Santa Clara Valley*
Both of the above assu/rptions have not been substantiated, and the degree
of uncertainty is unclear. The uncertainty' in the PAH estimates is at
least two orders of magnitude and, for B(a)P, presumably even greater. In
order to clarify the quantitative risk, estimates, the uncertainty in the
estimates of B(a)P exposure and toxieity should be discussed*
Future monitoring of organic particulates should include the deter-
mination, of particle size distribution, and the size distribution of the
relevant organics within the aerosol phase. Such information is necessary
in order to assess the rate of dry and wet deposition of particulate
organics,
E. Exposure and Health Risks
Estimation of chronic health risks for many toxics derive from total
exposure and, thus, the consideration of incremental exposures could be
misleading. This is less of an issue for carcinogens where most commonly
used dose-response curves are linear at levels where exposure occurs?
hence, incremental risk, is relatively independent of the baseline escposure,
This is not the case, however, for systemic toxicant where the estimated
exposure may be less than an assumed threshold level 3t which effects
occur. Mien the estimated exposures are added to e
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scientific document by including pertinent technical references. For
example, references should be included for the C££ methodology and the
EPA health assessment documents (or similar sources) for all the potency
and reference dose numbers used in the revised Phase I report.
Ihe 1 wilted assessment of non-cancer health effects appears to
be baaed only on the reference dose. It also appears that pressure fron
some of the local participants led the authors to include the discussion
of non-cancer health methodology in Appendix B of the study. This appendix
is incomplete. It is unclear how potency estimates ace developed from
the data, and table B-l and subsequent graphs cite unreferenced numerical
information*
Given that the assessment of health risks addresses mostly carcinogens,
the use of average rather than peak exposure levels is appropriate. For
non-carcinogens, howevert the question of the acceptable method to measure
dose over time can become very important. The above approximate approach
nay be adequate (in a Phase I analysis) considering that the objective of
the study is to identify substances and exposure routes for further
scrutiny (in Phase II) rather than carry out detailed analyses to estimate
the incidence of health effects.
Aside fron the above concerns with the methodology, the Subcommittee
has concerns with the discussion of the estimated health risks associated
with exposure to treated drinking water. The study concludes that
"Trihalcmethanes (THM) appear to account for a substantial portion of
the total health risks from surface water souces of drinking water."
Moreover, "different disinfection technologies exist that result in
different THM levels; thus, THM exposure is potentialiy controllable to a
significant extent. Based on data from the SCV" Water Department, we
estimate that chloroamination reduces THM levels, ano, thus risks, by
about 1/3 from TIM levels generated by chlorination tlone." The above
conclusion is based upon an oversimplification of the water treatment
issue because it ignores the efficacy and other potential impacts of the
treatment alternatives. The National Research Council addressed the
health effects of disinfectants and their by-products (Drinking Water and
Heal tB, Volume 7), and it appears that these issues ^re ntore complex than
perceived by the study's evaluation.
Finally, the Subcommittee notes that exposures Irrou indoor air, both
residential or occupational, were not addressed in Phase I. Also, the study
did not consider exposures due to episodic releases o£ air contaminants.
Exposures through dietary intake, dermal contact, and soil ingestion
(primarily by infants) were not addressed in Phase I, nor is there an
indication that they will be considered in Phase II. As a result, the
health risks due to exposure to PMs, lead and other metals via dietary
intake and -soil ingestion will remain unresolved unless considered in
Phase IT of the study.
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F. scientific Uncertainty
V"
Many questions arise regarding uncertainty In the risk analysis.
How do the uncertainties in the source and emission data or estimates,
transport modeling, exposure and dose-response carves arrf extrapolation
procedures propagate in the analysis of the health risks? Dtiere uncer-
tainties exist, they should be, to the extent possible, quantified and
carried through the various analyses, and stated clearly in the report.
This significant part of the analysis was not addressed as fully as
desirable in the Phase I study. The effect of scientific uncertainties
on priority-setting in Phase II was not considered, and this point should
be revisited.
G» Connunication of Scientific Information, and Public Perception
of the Santa Clara Valley Study
The role of both the Intergovernmental Coordination Committee (ICC)
and the Public Advisory Committee (PAC) was to provide the IEMP staff
with feedback regarding local cotmunity concerns, and suggestions and
critiques regarding the direction and progress of the study. The ICC and
PAC also provided the forum that facilitated ccnrnunication and, hence,
integration of community involvment. Through the participation of the
ICC and PAC, the IEMP staff succeeded in mobilizing the ccramunity to
participate in the various stages of risk analyses and risk management.
The IMP staff appear to conceive of their role in this study as primarily
that of process facilitators. This is a considerable departure from the role
assumed by the IEMP staff in the early stages of tl'w Phase I Baltimore
study.
All parties perceive risk eoiwunication to be ..:i inp^rtant factor in
the project. Seme corrwiunity participants interviewee by the Subcommittee
argued that scroe of the underlying assumptions regarding the air and
ground water contaminant transport models and their consequences were not
clarified to the full satisfaction of the advisory e'.jmmittees. In general,
however, members of the'PAC and ICC have expressed enthusiasm and support
for the continuation of the IEMP work in Santa Clara even in the light of
an initially imperfect process*
A point of great concern to the Subcommittee is that it appears that
the only independent scientific critique during the progress of Phase I
of the study was provided by the ICC and PAC. Many members relied upon
for peer review were not trained in the requisite scientific disciplines
to conduct a thorough review. "While it is encouraging that the PAC and
ICC were concerned with various scientific assumptions of Phase I, it
does not appear that they had tnuch impact on the scientific approach taken.
For example, suggestions made by the PAC that were not followed by the
IEMP include: 1) requests for clarification of uncertainties associated
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- 41 -
with risk miabersy 2) inclusion of Indoor exposure assessment? 3) addition
of sane key:pesticides to the chemicals evaluated by the IEMP; and 4) the
request for quantifying the uncertainty associated with the assumptions
made in the ground water contaminant transport models. Although the
participation of the ICC and P&C committees helped to build In a system
of checks and balances, they were not capable of providing a rigorous and
inpartial scientific review that would be recognized as such by the
scientific community.
H. Synopsis of Major Subcommittee Comments
The task of the IEMP, as perceived by the public, is to identify
risks to public health posed by exposure to toxic contaminantst to compare
the risks from such exposures in order to prioritize research and management
strategies, and to develop alternative approaches that can be used by
local government to manage such risks effectively. Several expressions
of this public perception (e.g., as indicated in the Bay Area Monitor
Newsletter published by the League of Women Voters of the Bay Area, and
as indicated by members of the PAC Committee) note that the IEMP applies
the best available scientific knowledge and management skills to compre-
hensive, erwitormentally related public health issues. Consequently,
despite the fact that risk numbers are highly approximate, they have been
quoted as absolute numbers.
The Santa Clara Valley ccwtonity depends on the IEMP to provide
accurate risk analysis. Without the IQMP involvment as the organizing
body, it is unclear whether the members of the various state and local
organizations are likely to commit resources for a long-term endeavor.
Phase I of the study could have benefited from a more thorough
process of scientific review during the design and implementation phases
of the study. The Subcommittee understands that the IEMP sought to
enhance local acceptance of the study by using local expertise but, in
the future, it may be advisable to also achieve a better balance between
experts with greater scientific stature for the issues under review and
local knowledge. These deficiencies are exemplified by the desire expressed
by some members of the advisory committees for having an IEMP team composed
of a greater number of scientists as opposed to policy analysts.
The IEMP needs to improve its Phase I screening procedure.
The identification of problems and detailed analyses in Phase II will
require a great deal of specific expertise and sophisticated methods beyond
those employed in Phase I. The Subcommittee also urges the IEMP to
better formulate and document the general IEMP assumptions and approach
so' that it might serve as a framework for other regions of the country,
Finally, the Subcommittee recognizes the advances achieved by the IEMP in
communicating risk to the people of the Santa Clara Valley.
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- 42 -
XI* DENVER IEMP PROJECT
Although not initially a part of the review, the Subcommittee
believes it is appropriate to include comments on the design of the Denver
IEMP project* Hich of the information presented from other studies is
new severalvears old, and the IEMP process has undergone significant
changes in approach, methods and personnel. The Subcommittee's comments
on the Denver study focus only on the overall study design1 and process
described through a brief ing since the study was in the early stages of
implementation when presented to the Subcommittee.
Denver is not, in the true sense, a multi-media study. It is not
designed to track the transport of pollutants. Rather, it is designed to
identify and evaluate the major environmental problems in the Denver area
from various media, with a clear emphasis on air toxics. The specific
scientific objectives of this study rsnain vague, however* The non-
scientific objectives of the project have been clearly articulated and to
a far greater extent than in past studies. Managers of the Denver study
are receivirtg direct input from other units of EPA. Hopefully, this
broader participation of Agency scientists will not only improve the
technical quality of the study, but will increase the resources available
for the project and improve the utility and long-teem impact of the
findings.
Through cooperation with QRD, the Denver project staff currently plan
to conduct extensive environmental monitoring. This will decrease the
need to rely upon historical data files and will provide a mechanism for
validating transport and exposure models, an element lacking in previous
studies. In addition, the staff plan to use models that have undergone
Agency review by ORD or outside scientific groups. This will include the
use of the Agency's published guidelines in conduct ing health risk
assessments.
Realizing that the value of the study's results may depend upon local
community acceptance, project planning will include extensive state and
local involvment. The importance of effective communication of results
is also considered, and will be facilitated by an evaluation of local
perception of risks as well as a risk education program.
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XII. Appendices
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\ UNITED STATES ENVIRONMENTAL PROTECTION AGcNCY
| WASHINGTON, D.C. 20460
OFFICE OF
POUCY. PLANNING AND EVALUATION
Dr. Ronald
Chair, Integrated Environmental
Management Subcommittee, SAB
Electric Power Research Institute
3412 Hillview Avenue
Post Office Box 1041
Palo Alto, California 94503
Dea r Dr. Wy zg a ?
This letter responds to the following request in your
letter to me of October 3, 1986;
"(please) outline:
a), the current objectives of IBMP,
b) the current organization,
c) the current modus_ operand! of the program
including descriptions of interaction with local
committees and other groups within EPA,
t
d) the major achievements to date of the program,
and
e) the criteria by which you feel IEMP should be
evaluated."
The panel has frequently exoressed concern about
the changing nature of IEMP objectives and organization —•
"your reauest is evidence of that concern. While the panel
is certainly, accurate in its perception of change, to IEMP
this has seemed like a reasonably natural evolution of what
was originally a pilot program over the course of the
last fiv« years.
I believe it is difficult to understand fully current
IEMP objectives*and organization without having a sense of
the history of the program* On the other hand, I want to
answer forthrightly your request for .information. Hence,
this letter begins with an historical overview of !S.M-?/
but you can skip directly to page for response to the
questions you raise.
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- 2 -
A. History
If IEMP were a family, its storv would be told in terms
of thre* generations of progress: the Report of the first
year, than the ensuing lengthy hibernation (1981-1982},*
the beginning of the first studies in January* 1983 to the
Office of Policy Analysis reorganization in April, 1985; and
from then to now.
1. First Generation: 1981-1982
IEMP began as nothing more than an idea that there
ought to be a better way to integrate EPA's regulatory and
scientific procedures, particularly as those were changing
to meet the new challenge in the late 1970's of toxics
pollution.
There have been integration programs at EPA since its
formation in 1970. They were designed around varying initiatives
which promised better coordination among Agency program offices,
especially the air, water, and hazardous waste programs.
IEMP began similarly, as sponsor of several task forces asked
to recommend improved methods for coordirta-tion of chemical-
specific regulations and to increase scientific consistency,
But IEMP staff became impatient, rather quickly, with
integration goals of coordination and consistency* Fast
efforts with this premise had all failed because they seemed
•to ignore a fundamental organizational imperative; the first
loyalty of an environmental program is to its statutory
requirements. A program office decisionmaker, when confronted
with a request to compromise current procedures for the sake
of an amorphous larger purpose (*Agencywide consistency"),
could almost always argue that current practices reflected
the intent of his program's legislation. Past integration
programs became, in sum* a lot of talk (the Office of Program
Integration, under TSCA at IfiMP's inception, had a staff of
40 and a 54 million budget) and little action.
So the first IEMP task was to redefine "integration.1*
We reempliasized the central purpose of the Agency as the
reduction of risk to human health and the environment from
pollu-tion* We proposed using quantitative risk analysis as
the logical common denominator Cor establishing risk reduction
priorities among EPA's air, water, and hazardous waste
.programs, for tracking unintended pollution transfers resulting
from regulation, and for measuring environmental protection
progress. We suggested using cost-effectiveness techniaues
to help select pollution control technologies. And inherent
in these redefinitions was the notion that more efficient
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integration of environmental functions required more centrali-
zation of deeisionmaking.
In practice» the Administrator's Office of EPA has always
been wȤM, though it was not originally intended to be.
The Ash Commission, whose recommendations structured
the new Agency, recognized the potential devis.'iveness and
inefficiencies of an Aqency thrown together around eight major
statutes with no common charter. The Commission contemplated
a reorganization of EPA, soon after its formation, along
functional lines. Administrator Buckelshans, however,
during his first tenure, was stymied in his attempt to
implement that recommendation by the many sub-committees
of Congress intent on maintaining their jurisdictional
authority.
lEMP's early notions, then, required an administrative
strengthening of the Agency. Integration by, establishing
cross-media regulatory priorities and leading to more efficient
risk reduction assumed the Administrator as sole client of
better management practices. lEMP's job, then, was to provide
tools the Administrator could use for this more hands-on
Agency management.
At the end of the summer, 1981/ IEMF wrote and submitted
to the Administrator a Report proposing substantive and
management recommendations to enhance toxics (lEMP's mandate
was not broadened beyond toxics until 1983) integration. I
am including a copy of that Report with this letter and ask
.that you take a few minutes to skim its findings. In several
ways, it represents a haicyonic moment in the history of
EPA's attempts to integrate its functions. The Report
was far-reaching. Much more important, however/ the Report
represented the consensus of a review committee consisting o€
the ten managers of EPA's major programs. It was an unusual
moment, in other words/ during which significant change wag
promised with broad civil service support.
Alas, the new Administration saw it as their historical
momentf. not our's. They suspected IEMP to be just another
attempt by bureaucrats to launch a new program; their plan
was to gst rid of programs. The Report was shelved, and
IEMF w*s^essentially disbanded for a year.
> •
2. Second Generation: 1983 to April, 1985
Toward the end of 1982, IEMP was partially resurrected.
While the program was given only part of the resources and
none of the authority requested in the 1981 Report* IEMP
was asked to begin industry and geographic studies.
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- 4 -
a. Industry Studies
it is hard, now, not to grimace at some of our
original naivete, but here, anyway, is the short story of
Industry Studies.
In 1981, it seemed to be the case that most environmental
regulation was of point sources in large, and largely aging,
manufacturing industry sub-sectors. In searching for.a way
to demonstrate the practical management value of quanti-
tative tools applied cross-media, a logical target was these
industry sectors.
The objective of these studies was, specifically, to
provide the Administrator with a ranking of the pollution
control technology options that maximized risk reduction
while taking into account risk transferred by that technology,
and optimizing for cost-effectiveness. The idea was that
that the Administrator could compare this priority list with
the current regulatory activity affecting the industry being
studied, jettison program initiatives not on lEMP's priority
list, and initiate program work on those initiatives that w«r«
high on the priority list. Assuming that the main business
of EPA was regulation of these industries, achieving this
objective would, by our definitions, assure significant
Agency integration.
You have been briefed in some detail about how IEMP
went about these industry studies.. In short, we constructed
large computer models designed to produce cost-effective
technology options consonant with study objectives. With
iron/steel, our first real application of the industry method,
IEMP followed through with recommendations to the Administrator,
including an analysis of the incongruity between priorities
from the IEMP model- and regulatory work for iron/steel then
underway in the air and water programs. The Administrator
told IEMP to work out its differences with the affected
programs.
IEMP initiated four other industry studies, much in
the same vein. But by the Spring of 198S, it had become clear
that th«»* industry studies were serving no great purpose;
they w«r» becoming particularly unsupportable given their
great ttiirtt for contract resources.
In sum, the industries approach to integrated environmental
management did not turn out to be very successful —' for the
following reasons:
First, uncertainties, or lack of consensus regarding the
credibility of quantitative information possessed by the Agency,
was even more overwhelming than IEMP expected. I£MP always
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argued that some information was better than decisionmaking
based on almost no information at all. But in 'fact, EPA's
data bases were so thoroughly suspect that cross-media analyses
carried'out through huge modeling projects were seen to more
likely compound error and assumptions to the point of use-
lessness *
Second, .data was too limited in many instances, further
undermining the credibility and robustness of the industry
models. Almost nothinq was known, for instance, about the
human health risks associated with complex mixtures in
waste dumps. We could not convincingly represent non-cancer
health effects, nor were there methods for quantitatively
assessing ecological impacts. Huge as these models became,
in other words, they were never enough to mirror what others
suspected were possible effects of pollution. How could
their outputs, then, be real Agency priorities?
Third, and perhaps most unnervingt was the realization by
1985 that only a rather small fraction of EPA regulation
was addressing the old industry sub-sectors* For a variety
of reasons, regulatory attention had begun shifting rather
dramatically to hazardous waste, pesticides, and other issues
not easily amenable to industry modeling.
Fourth, the business end of the industries approach,
re-orienting regulatory work in the programs, relied too
much on the Administrator. It required an impractically large
Amount of an Administrator's time to understand and continually
enforce IEMP recommendations. This shortcoming would have
been addressed if suggestions in the 1981 Report had been
implemented.
From about mid-1984 onward, then, the Industries Branch
increasingly shifted attention to policy studies which involved
cross-media analysis — sludge, and pesticides, for instance.
These studies employ many of the techniques of the industry
analyses: use of quantitative risk analysis to define problems
'across media and to track pollution transferred by potential
control options, and cost-effectiveness. And the objective
of the sludge study, for instance, was to develop a list of
cost-effactive pollution control options which EPA's water
program would then implement through sludge regulation, lE^P's
sludge work, now finished, is being reviewed by another SAB
panel, but included as appendix to this letter is a recent
•memo from lEMP to the Administrator which conveys findings
of this IEMP work,
b. Geographic Studies
The original grand vision of IEMP assumed successful
integration of federal operations during the first 3-4 years,
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- 6 -
then a shift of emphasis to regional, state, and local integration
we anticipated that environmental protection would increasingly
be carried out through non-federal authorities from the late
1980fs .onward. We assumed this because it seemed the most
efficient approach: while gross, ubiquitous pollution
problems might best be handled through federal regulation,
environmental problems unique to local areas and driven by
particular local exposure situations (Houston ship channel,
Los Angeles smoq, New Jersey waste sites) should obviously
(it seemed I be resolved through special pollution control
strategies tailored locally Cor that purpose*
Independent, then, of ISMP's difficulties implementing
the federal or industries integration recommendations, we did
expect to shift attention over time to local Integration
studies.
The initial challenge of the geographic' approach was to
translate general concepts -- use of quantitative risk assess-
ment applied across media to establish priorities, minimiza-
tion of pollution transfer, use of cost-effectiveness to
help select pollution control technologies — into a workable,-
practical environmental planning and management process at
the local level. Our work first in Philadelphia, then Baltimore,
Santa Clara, and now Denver is mostly, as you know, a story
of trial-and-error leading toward a functional process model
for local integrated environmental management.
While it is not necessary to retrace these projects on
which the panel has already received lengthy presentations,
it may make sense to summarize several of the major lessons
learned from past studies that helped lead ISMP to its current
model or objectives for geographic projects.
1) In Philadelphia, we began with a very com-
prehensive process for selection of problem chemicals. The
project compiled a list of about 450 potential chemicals,
then attempted to generate a data base consisting of all
available information of those chemicals. The plan was to
assess' the risk for all those chemicals as a first step in
setting priorities for further study.
this kind of comprehensive pollutant selection, or
winnowing process became far too expensive and time-consuming
given IEMP project limits. Since Philadelphia, we have
relied far more heavily on the expert judgment of local,
regional, and federal officials involved in the project for
initial definition and selection of problems. This means, in
particular, that the actual scope of geographic projects is
ultimately based on the judgment of IEMP staff, advised by
local experts and reviewed by local technical committees. It
also underlines the point that IEMP projects are in no sense
comprehensive. Instead, they are limited studies whose scope
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is guided by the following general criteria;
0 what seem to expert officials to be the major
environmental problems which EPA has the tools
to further analyze (for instance, we would
select air carcinogens over a diffuse wetlands
pollution problem) and which may be possible
to control using non-federal authorities?
* oroblems selected should encompass more
than one environmental media? and
a ideally, problems selected already have a
data base because IEMP can contribute risk and
cost analyses far more easily than it can
provide large resources for data acquisition.
25 IEMP also learned, in Philadelphia* its first
lesson about the imnortance of local participation in the study
process. (This point was driven home to you directly, and
unfortunately for us, by the statements of Philadelphia
officials at the July panel meeting.) Local officials must
not only be involved at every step of the way, in ISMP projects,
they must be given sowe control over project decisionmaking.
The question is; what is the best balance between IEMP and
local control?
In Baltimore, ISMP shifted strongly in the other
direction: the Baltimore technical and management committees
are primarily responsible for substantive project decisions,
with IEMP staff serving as support to those committees. This
method too, however, though quite workable in Baltimore, does
carry some disadvantages. The pace at which unfettered local-
committees analyze and decide, and the resource demands they
are inclined to make, conflict with bureaucratic imperatives
at EPA, It is very difficult to support (outside of the
Office of Research and Development) long, expensive projects
•which have few practical interim products,
Santa Clara seems to represent the bast balance. .On
one hand, the project emphasizes the broadest feasible com-
munity participation in all aspects of work — an often
harrowing process, but one which seems to lead to public
understanding and acceptance of project decisions. On the
other hand, federal officials maintain operating control over
the project during the first, risk assessment staqe —
thus contributing to efficient delivery of results. The
balance of control then shifts to local committees during
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_ a -
the risk- management phase, which is appropriate given lEMP's
objective of having local officials take maximum responsibility
for replacing pollution in their jurisdiction.
IB.;J"'
"''•• 3) To be candid, IEMP is not certain at this
point about whether and to what extent projects should employ
non-cancer health effects methods in selecting pollutant
priorities, IEMP has encouraged use of this information, because
it promises fuller understanding of pollution effects in a
local area, but limits its applicability to the initial
screening stage of analysis. There is little scientific
support, however, for using more than the Agency's RfD
(reference dose) numbers, and for making a qualitative judg-
ment about characterization of the risk for local populations.
Until there is more scientific credibility supporting quanti-
tative dose-response relationships for non-cancer effects,
should IEMP limit itself to the qualitative approach even in
the initial screening phase of geographic projects?
3. Third Generations May, 198S - present
Before summarizing recent organizational changes which
affect IEMP, I should touch on another aspect'of the program
during the past several years. This aspect is an aside
from the discussion of federal and local integration projects*
To the extent that your panel is interested in knowing
.what IEMP has more generally defined for itself as its mandate,
it is important to note that the program has or is sponsoring
many projects related to integration which are not captured
within the industry/geographic rubric. These projects have
not formed the panel's review of IEMP to date? perhaos they
are unreviewable, at least in a technical sense. Nevertheless,
ironically, these projects may be among lEMP's more important
contributions to long-term integrated environmental management.
Almost all of them are aimed, not at developing practical,
usable integration models, but at strengthening the credibility
'of the .concepts undergirding lEMP's approach to integration:
use of quantitative risk assessment and management techniquesr
B«iow is a list of the major projects:
a. Writing all of Ruckelshaus' major speeches during
his second tenure, through which risk assessment, risk manage-
ment, and the importance of local decisionmaking were detailed
and popularized;
b. Preparation of Risk_Jessessment and Risk Management:
Framework for Decislonmakinq, a primer on these concepts
over 1Q,QQQ of which have "been supplied in response to requests
from a variety of sources?
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c. Development of fte** training courses on risk
assessment and risk management, which have been given to over
1600 environmental employees, media representatives. Congres-
sional staffers, and others during the past year?
d. Staffing, for Ruckelshaus directly, the interacency
Risk Assessment Council;
e. Preparation o€ EPA's Six Month Report on -Air
Toxics, which used innovative work done in the Philadelphia
study on area and other non-traditional pollution sources
to help define the nature and extent of cancer incidence from
selected toxic air pollutants in urban areas of the United
States. Results of the Study also reinforced other IEMP
assumptions, such as the importance of understanding the
cumulative risk to an individual from many pollutants and the
variaoility of exposures among geographic areas; and
f. Responsibility for directing and staffing the
Toxics Integration Task Force under Al Aim, which sponsored,
among other things, the development of EPA's five risk assess-
ment guidelines.
The Office of Policy Analysis reorganization in April, 13SS,
did two things: it added hasardaus <4aste policy analysis to
IEMP, now renamed the Regulatory Integration Division, and
it led to the imminent demise of industry and policy studies
rin favor of a purely science/technical support Branch. The
only integration functions now remaining in the new
Division are geographic projects.
Other than the Kanawha project, to be discussed at
another meeting of your panel, the major recent initiative of "
IEMP has been the selection of Denver as the next geographic
project. (IEMP has also helped support and been strongly
involved in a new program to encourage integrated environmental
management and planning at the State level. That initiative
and its implications for the future are briefly described
at the end of this letter.} This history section concludes
with a discussion of the criteria IEMP used — though the
Administrator made the final decision — to select the next
site for a geographic project.
The criteria were*
a. A site not in Region III or Region IX, where
IEMP already has projects. We wanted to proselytize in
heathen areas,*
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- 10 -
b. a site that appeared to contain a major environ-
mental problem, so IEMP would not be wasting significant
resources on trivial issues,-
c. a site that appeared to have more than one signi-
ficant problem? given the premise of integrated or cross-
media analysis?
d, a site whose problems, if verified, were control-
lable, particularly with -maximum use of local authorities?
e, a site in which IEMP could tamke a significant,
perhaps unique, contribution through use of its analytic
tools;
f. a site at which IEMP would have strong support
from the Regional Office and, hopefully, local officials?
g, a site at which a reasonably extensive data. base
already existed for the major issues likely to be studied?
and
h. a site to which IEMP staff could travel reasonably
cheaply and
The final four candidates — Boston, a county in
New Jersey, Jacksonville, and Denver -- were all viable. The
Administrator decided* on balance, to pick Denver, presumably
because of the importance of attempting to address Brown
Cloud issues and hazardous waste problems at that site.
®" Current Objectives of IEMP geographic Projects
The qeneral qoal of IEMP is to develoo a model £oe local
environmental management that (1) is integrated, to the extent
that it has an analytically defensible basis (quantitative,
if--possible) fas establishing pollution risk reduction priorities
across media; (2) that takes into account both cost-effectiveness
aȣ fetwittfai for pollution transfer in selecting pollution
control remedies; (3) that can be practically used by local
officials! and (4) that contains an implementation process
which maximizes the potential for broad public understanding
.and acceptance of management decisions.
Specific project objectives ares.
9 to develop an initial list of potentially
significant problems, limited in number by
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-li-
the resources available to the project, far
further analysis, and based on the judgment
of the widest possible range of local and
federal technical experts;
0 to gather data necessary for further analysis
of these problems, limited again by project
resources?
0 to analyze problems on the initial list using,
to the extent possible, quantitative 'analysis
' but balancing quantitative uncertainties with
expert local judgment;
0 to prepare a report , at the Conclusion of
the risk assessment phase, which summarizes
data and analysis regarding the nature and
extent of the risks associated with problems
on the initial list, and which assists local
decisiontnakers in establishing priorities both
for further study and for control actions?
8 to develop a list of potential pollution
control options for priority problems not
already being addressed. by .local officials,
and then assess the cost-effectiveness and"
pollution transfer potential of those options!
9 to prepare a second report which again assists
local decisionmakers in selecting specific
control actions. These actions should
employ, to the maximum extent feasible,
local authorities!
0 to secure implementation of report
recommendations;
e
to develop, from the beginning of the project,
local technical advisory and management com-
mittees. The technical committee, at least,
should be broadly representative of general
public, as well as technical, interests?
" to establish working relationships with these
committees in which all significant project
information, analysis, and decisionmaking is
shared j
0 to transfer the balance of management control
of the project to the local management committee
during the second, risk management phase; and
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o
- 12 -
to provide training in risk assessment, risk
management, and risk communication to local
officials as is necessary and appropriate.
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- 13 -
C, Current Organization of IS*P
Office of
Policy Analysis
Regulatory Integration Division;
Hazardous
tests Policy
Branch
staff: 15
budgets S2M
Geographic (IEMP) Stanch;
Santa Clara
Project
, (K. Hinman)
Budget; S35QK
Director
(D* Beardsley)
Geographic
Branch - 1EHP
(5.
staff: 12
budget: S1.3M
Chief
(S. Napolitano)
•Special Asst.
(P.
Clerical
Staff
Technical
Assistance Bc«
(T. Barry)
staff: 6
budget: S500K
{includes
Oc, Berlin)
Clerical
Staff
Baltimore
Project
(J. Charaberlin)
Budgetj S350K
Kanawha Project
(Region III,
D. Lee)
Budget: $100K
Denver
Project
(K. Llovd)
Budget: $500K
Some technical support is provided to the Geographic projects by staff members
in the Technical Assistance Branch.
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- 14 -
D* Current ModusOperandi of IgMp
Th« objectives of our interaction with local committees for
IEMP projects are listed above. I assume that details of these
interactions, and lEMP's effectiveness in structuring and managing
this process, have become clear to those members of the panel
who were involved in the site visits to Baltimore and Santa
Clara.
IEMF does not currently have any standing arrangements
with other groups within EPA for review or comment purposes,
Our usual procedure is to call upon individuals within program
offices for technical advice or review on a particular issue
within a geographic project — staff have had hundreds of con-
versations and meetings of this type during the past several
years. Occasionally, more formal advice/review processes are
established for a specific purpose, such as the recent workshop
sponsored by the Office of Research and Development on the pro-
posed air monitoring plan for the Denver project. The committee
established for the six-month air toxics study is another example
in which members from OAQPS, ORD and QPPE participated In
the study front its inception.
IEMP has considered several times the idea of developing
a formalised OP.O review group for geographic projects. We
have always decided against tilts, because GRD has never been able
to dedicate its as-m -scientists to IEMP work. Instead, we
established the local peer review panels for Baltimore, Santa
Clara, and now, Denver.
E. Major Achievements of IEMP
It would be convenient, if not appropriate, to be able
to take credit for1' much of the work done in the Agency during
the past several years to expand the understanding and credibility
of key concepts supporting ISMP's approach to integration:
management uses of quantitative risk assessment, for instance.
It is certainly the case that IEMP has performed a service
in this area through its non-routine activities, and in
particular for- ensuring that regulatory proposals by Agency
program offices take into acocunt the potential for mere transfer
of pollution to another media.
For specific accomplishments, I asked my staff to list
what they see as the benefits of the local geographic projects.
Rather than summarize their responses, I am including their
mereos to me as an appendix to this letter. I think they convey,
directly if not impartially, an "in the field" sense of the
utility of improved approaches to local environmental management.
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F* Criteria By Which IEMP Should Be.Evaluated
I think just two questions, now, are important.
1. Has ISMP developed an analytic and process model, as
defined by current objectives, which will assist local officials
in better management of their environmental problems, and is
lEMP's approach practical to implement?
2. Based on your review of the Baltimore and Santa Clara
projects, is IEMP using scientific and other analytic techniques
appropriately and effectively? In a-related matter, what would
you recommend regarding future methods for research on and
use of quantifying non-cancer health effects?
G, IEMP In The Future
IEMP was never intended -— by the Agency or by the Office
of Management and Budget -- to be a permanent program. Policy
offices traditionally do not manage line functions over the
long term. Hence, there has been an increasingly immediate
expectation that IEMP would become "institutionalized" or
taken over as a regularized function of another office. To
that endf we began participation several years ago in a State
Pilots Program (SPP5. This year, we are assuiaing responsibility
for that program; beginning next year, it will replace local
projects like Baltimore, Santa Clara, and Denver as the pri-
mary focus of IEMP. Subsequent funding for IEMP will diminish
as we expect EPA's regional offices and the States to taKe
responsibility for integrated environmental management.
SPP began in 1984, under the sponsorship of EPA's
Office of Regional Operations, as a limited experiment in
assisting the States to develop integrated data management
and environmental pollution mapping functions. Since 1984,
IEMP has been providing partial supoort -- funds and
staffing -- for this initiative. During the past year,
IEMP has encouraged a stronger emphasis en States' use of data
and risk/cost analysis techniques, as well as practical use
of these, tools in environmental decisionnaking. In other words,
IEMP ha* increasingly viewed the SPP as a. vehicle for imple-
menting -IEMP objectives at the State and regional levels,
This year, SPP will again be a limited effort. Final
funding and objectives are still under review by the Admin-
istrator, but we will probably fund small (about 5150,000 apiece
demonstration projects in Region IV — Kentucky, Georgia and
the regional office itself. These projects will reflect
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_ 15 -
our experience with IEMP local projects and the Office of
Regional Operations' past work with the SPP.
Thank you for allowing me to respond to some of your
concerns regarding IEHP. I look forward to seeing you ar^in
at the panel meeting in December. again
Cordially,
"*"* ' -
&t3n&U<4
Dan Beardsley
Director
Regulatory Integration Division
Enclosures
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Appendix B
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
: WASHINGTON, o.c. 20400
May 27, 1987 SAB-EC-87-031
Honorable Lee H. Thomas
. , oFK'Ct c»
Administrator Tne ADMI^IST^A
U. S. Environmental Protection Agency
401 M Street, S. w.
Washington, D. C. 20460
Dear Mr. Thctnasi
The Science Advisory Board's Integrated Environmental Management
Subcommittee has completed its review of EFA's Craft Kanawha Valley Toxics
Screening Study and is pleased to transmit its final report to you. The
Subcommittee met in public session on March 16, 1987 in Philadelphia,
Pa., to review the study. During March 11-13, 1987, three representatives
of the Subcommittee visited the Kanawha Valley to become more familar
with its enyi rormental problems.
The Subcommittee unanimously concludes that the Kanawha Valley study'
represents an important component of EPA's overall effort to develop
methodologies to define public health and environmental priorities.
Studies such as this provide valuable technical challenges and experiences
to EPA staff, particularly those working in regional offices. Andf
finally, they provide a valuable means for developing closer working
relationships with state and local officials and the general public.
This letter is the Subcommittee's second communication to you. On
July 30, 1986 it expressed "many concerns about the ability of the current
study to satisfy a number of technical issues. A chief concern is the
incongruity between [the study's] .... objectives and the fact that the
study design itself is not an integrated multimedia effort, nor a response
to Bhopal."
Since- the transmittal of that letter, EPA staff have modified the
study's objectives and technical design, and have conducted supplementary
analyses to support the revised objectives and design. In general, the
Subccmmittee believes that the staff have made appropriate responses to its
major concerns. The study reaches a number of scientifically supportable
conclusions about health risks from cancer in the Kanawha Valley. The
study also points EPA and other interested parties in a direction for
conducting further analyses of problems related to accidental releases of
pollutants and acute health effects.
Specific issues addressed during the Subcommittee's review include:
the study's objectives and scope? pollution sources; pollution transport
and fate by media; health effects; risH ccntmnication; and recommendations
for additional follow-up efforts. Attachment A presents additional, more-
detailed recommendations for modifying the current study and future
activities in the Kanawha Valley, Attachment B lists the Subconraittee
members.
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- 2 -
In generalf the Subcommittee views the Draft Kanawha Valley Toxics
Screening Study as one step of a continuing process to assess risks. Hie
current study addresses chronic health exposures to carcinogens which
represent one of many public health concerns in the Valley. As a follow-up
to the current study, the Subcommittee recommends two additional steps
that include: .
o Expanded monitoring of air toxics, and use of monitored values
to obtain more precise estimates of exposure and health risks,
o Greater focus on accidental releases and fugitive emissions as
areas of public health concern.
The Subcommittee appreciates the opportunity to conduct an independent
scientific review of these important public health issues in the Kanawha
Valley. We request that EPA formally respond to our scientific advice.
Sincerely,
Ronald Wyzga, Chaioaan
Integrated Environmental
Management Subcommittee
Science Advisory Board
If
Norton Nelson, Chairman
Executive Committee
Science Advisory Board
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SAB-EC-87-031
MAJOR FINDINGS AND RECOMMENtmTIONS
OF ME
*
INTEGRATED ENVIRONMENTAL MANGEMENT SUBCOMMITTEE
ON THE
0. S. EIWIH5NMENTAL PROTECTION MSENCY'S DKAFT
KANAWHA VALLE¥ TOXICS SCREENING STUDV
INTEGRATED ENVIRONMENTAL MANAGEMENT SUBCOMMITTEE
SCIENCE ADVISORf BOARD
U. S. ENVIR)NMENTAL PROTECTION -AGENCY
May, 1987
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U. S, SNVIFiDNMENTAL PROTECTION AGENCY
NOTICE
This report has been written as a part of the activities of
the Science Advisory Board, a public advisory group providing
extramural scientific information and advice to the Administrator
and other officials of the Environmental Protection Agency. The
Board is structured to provide a balanced expert assessment of
scientific matters related to problem facing the Agency* This
report has not been reviewed for approval by the Agency, and
hence the contents of this report do not necessarily represent
the views and policies of the Environmental Protection Agency,
nor of other agencies in the Executive Branch of the Federal
government, nor does inention of trade nawes or commercial products
constitute endorsement of reccoinendation for use.
-------
StudyObjectives and Scope
The objectives of the Kanawha Valley study are limited, but reasonably
well-defined. In most instances, the study seeks to derive an upper bound
for the health risks associated with airborne carcinogens' for which
SPA's Cancer Assessment Group has derived potency estimates. Other
potential carcinogens are minwially considered, and the health risks of
non-carcinogens, including those risks associated with the accidential
release of chemicals such as occurred at Bhopal, are not considered,
Hence, the health assessment of airborne toxics is far from complete, but
this is clearly articulated in the study report. Available resources did
not allow a more comprehensive assessment.
The study attempts "to develop a sense of potential public health
concerns" associated with carcinogens in drinking water, surface water
arid hazardous wastes. The efforts are not multimedia efforts, but medium-
specific efforts based upon very limited data? thus, conclusions from
these efforts are subject to considerable uncertainty.
Sources
The air analyses depend very heavily upon an emissions inventory of"
some 450 substances developed by the West Virginia Mr Pollution Control
Commission (APCC). The inventory is as extensive and comprehensive as
any other available information. Nevertheless, there exist some
uncertainties in the inventory, particularly with respect to fugitive
emissions, which the study identifies as a major source of health risk in
some Kanawha Valley communities. The possibility that the inventory is
incomplete is also suggested by the Eact that ethylene oxide was not included
for either the Belle or Nitro corminities despite some limited monitoring
evidence that it may be present. If a compound was not in the inventory
it was not included in subsequent EPA modeling. This discrepancy underlines
the need for including ethylene oxide in future monitoring programs.
The drinKirg water and surface water analyses depend upon monitored
levels of toxics in water supply systems and fish fillets, respectively.
Data are limited to a subset of all public water suppliers, with no private
well samples, and to a very small number of £ish saitipled from only one
location for a very limited number of toxic substances. The hazardous
waste inventory is based upon a priority pollutant screening of inventories
for a subset of RCRA and potential CERCLA sites. No information was
available on the total quantity and overall composition of toxic wastes
that may be entering surface or ground water. For this reason alone, the
results of this part of the study are, at best, suggestive,
Transport and Exposure
The transport models used in the studies generally appear to be
congruent with the study objectives. The air transport modeling addresses
the concerns of the Subcommittee in its July 30, 1986 letter, although better
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- 2 -
documentation of this modeling is needed. There is a factor of two
uncertainty on point source air emissions and another uncertainty of a
factor of two in dispersion modeling. The current modeling efforts do
not address these potential uncertainties, although "worst case" scenarios
should recognize their existence* Drinking water exposure was estimated
by assuming that individuals consume two liters of the water delivered to
their neighborhoods. Similar assumptions are often made in risk assessments,
The surface water and hazardous waste studies are greatly hanpered by a
lack of data, making large assunptions necessary to estimate exposure to
toxics.
Health Effects
The study evaluated 20 known or suspected cancer causing chemicals
from the West Virginia APCC inventory of more than 450 compounds. Hie
Subcommittee concludes that the current study provides useful information
on health effects frcm cancer and environmental loadings of these 20
compounds. After finalizing the current study, EPA should conduct additional
efforts that include;
o Using the APCC inventory and information on toxicity to evaluate
the potential health effects of seme of the remaining ccwpounds.'
Of the ranaining 430 or so compounds, relatively few merit further
attention, but EPA and APCC should work together to identify
compounds that need additional evaluation. These should be
identified by defining the set of those conpounds to which some
exposure"may be likely at known toxic levels.
o Broadening the health endpoints of concern to include non-cancer
and acute effects. Concern about the potential effects frcm
acute releases is strong within the ceramunity? hence, -sane
priority should be given to addressing this issue. The
methodologies used to address these endpoints require further
development, particularly in estimating the effects of accidential
releases. Some fault-tree or alternative analysis should be
designed to address this possibility. Experts frcm other groups
within the EPA should be enlisted in this effort.
o Incorporating frequency plots of pollutant concentrations versus
time, in addition to stating average pollutant concentrations.
o Assessing the conversion of reference doses frcm the ingestion to
the inhalation pathway, where reference dose information for the
inhalation pathway is not available.
o Evaluating whether to develop or use biological markers for health
assessment.
o Cellaring risks frcm high mass emissions of pollutants with low
toxicity, with low mass emissions of pollutants with high toxicity
as a means to identify priority risk management needs.
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- 3 -
o Exploring other potentially useful sources of data for compounds
of concern, including monographs prepared by the International
Agpney for Research on Cancer, Health Effects Profiles developed
. by, the Office of Research arid Development, leper-table Quantities
for hazardous compounds and gaining access to information through
the community right-to-kncw provision of Superfund.
Canminication of Risks
The Subcommittee encourages EPA to continue its*efforts of working
with officials and citizens of the Kanawha Valley to update them on the
sources and magnitude of risks they experience. In particular, EPA should
seek to further improve its presentation of technical information to
better enable lay persons to understand the results of technical analyses
and to tjnsure it is understood that the risk numbers reflect upper bound
estimates. Clarification of the latter issue is also needed in the
executive summary of the study*
It is important for citizens, scientists a«J public officials to
understand that the principal value of the Kanawha Valley study is as a
screening study of airborne carcinogens. As the study acknowledges,
a screening study should strive to ensure that all potential risks are
identified even at the expense of calling attention to risks that subsequent
analysis may not confirm, or will be less than indicated in the screening
study. Accordingly, assunptions in screening studies are conservative in
nature,- assunptions should be avoided that might cause potential risks to
be ignored. Within the stated scope of the study, conservative assumptions
are tnade; for example, individuals are assumed to be exposed continuously
to ambient outdoor levels of industrially emitted toxics and upper bound
risk estimates are given. There are a few instances, however, where the
study did not rigorously pursue conservative assumptions. ihese include
potential uncertainties or omissions in the emissions inventory, the
study suggests that point estimates cculd be too small (or too large) by
a tactor of two. For fugitive emissions it could be greater. It is
important that these uncertainties and their likely direction be clearly
articulated in the report along with a discussion about whether additional
scenarios ape necessary to consider these uncertainties.
In addition, the air quality models are equally likely to under-and-
over predict ambient concentrations. The biases of the models are fairly
predictable. Ejqposures are likely underestimated at the peaks of ridges
where the river turns and when overlapping models were not used. On the
other hand, the use of the Box asodel probably overpredicts exposure in
sane neighborhoods on the Valley floor, which are not adjacent to emissions
sources. Although it is to the study's credit to have iitf>lemented two
"different modeling approaches to estimate exposure, further discussion
in the report is merited on the potential model biases and on their
implications for the risk estimates.
-------
Attachment A
ADDITIONAL RECOMMENDATIONS TO THE
A, Current Report
1. The technical assumptions for the underlying transport models
should be documented and Kiade accessible to readers of the
report.
2. Given the comprehensive nature of the airborne toxic risk
assessment in contrast to the rudimentary nature of the other
three studies, it may be desirable to more clearly separate the
air toxic studies frcrc the others; moreover, the various studies
are undertaken tor differently defined geographic areas.
3. Itie risk estimate bounds are probably more clearly defined than
in mast similar documents; nevertheless, further clarification
may be necessary. Cases could be presented as
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!*T| ___
3, Hie hazardous waste data considered are very limited. CERCIA
requirements can perhaps provide sotte useful inforrtiation* Other
parts of 6PA should be enlisted to wprove the source inventory
for these data. Analysis of historical operations ar*d land use
raay also be useful to characterize the types of chemicals in
waste sites. The fundamental approach to consider risk from
hazardous waste should be replaced, however, by one that examines
specific waste sites.
4. Increased monitoring data can aid the analysis o£ drinking water,
surface water, and ground water. For chemicals of concern in the
Valley, such efforts should be instituted to 'help ensure that no
major problems are overlooked,
5. Health surveys and measurement of biological markers could provide
some validation of the estimated health profile of the Valley.
Such efforts will not, however, be useful when incremental risk
estimates are small.
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Attachment 8
U, S. ENVIiOWENTAL PROTECTION M3ENCY '
SCIENCE ADVISORY BOARD
'Integrated Environmental Management Subcoiraittee
Dr. Ronald Wyzga, Chairman
Electric Power Research Institute
3412 Hillview Avenue
Pest Office Box 1041
Palo Alto, California 94303
Dr. Stephen L. Brown
Environ Corporation
1000 Potomac Street, N. w.
Washington, D. C, 20007
Dr. Thomas Clarkson
University of Rochester Medical Center
Box RBB
57S EJUroood Avenue
Rochester, New York 14642
Dr. Herbert H. Cornish
830 West ClarK Road
Ypsilanti, Michigan 48198
Dr. Robert Frank
Johns Hopkins University
Department of Environmental
Health Sciences - JHSHPH
SIS North Wolfe Street
Baltimore, Maryland 21205
Dr. Rolf Hartung
School of Public Health
University of Michigan
Ann Arbor, Michigan 48109
Terry P. Yosie, Director
Science Advisory Board
U." S, Environmental Protection
Agency
401 M Street, S. w.
Washington, D. C. 20460
Dr. Thomas Burke
New Jersey Department of Health
Div, of Occupational & Environ,
Health CN 360
Trenton, New Jersey 08625
Dr. ¥oram Cohen
Chemical Engineering Dej>artinent
U. C. L, A. Soon 553\
Boelter Hall
Los Angeles, California 90024
Dr. Terry Davies
World Wildlife Fund
The Conservation Foundation
1255 23rd Street, N. W.
Washington, D. C. 20037
Dr. James Gruhl
7610 N. Christie Drive
rucson, Arizona 85718
Dr. Paul Lioy
University of Medicine and
Dentistry of New Jersey
675 Hoes Lane
Robert Wood Johnson
Medical School
Piscataway, New Jersey 08854
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- 2 -
Dr. Francis MeMichael
The Blenko Professor of
Environmental Engineering
Department of Civil Engineer!!"*}
Carnegie Mellon University
5000 Forbes Avenue
Porter Hall 123A
Pittsburgh, Pennsylvania 15213
Dr. Ellen Silbergeld
Chief Toxics Scientist
Environmental Defense Fund
1525 18th Street, N. W.
Washington, D. C. 20036
Dr. Warner North
Principal, Decision Focus, Inc.
Los Altos Office Center
Suite 200
4984 El Camino Real
Los Altos, California 94022
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Appendix C
INTEGRATED ENVIBONMENTAL MMIAGEMENT PSDOWI SUBCOMMITTEE
1. April 24-25, 1986
2. July 1-2, 1986
3. September 18-19, 1986
4, December 4-5, 1986
5. March 16-17, 1987
-------
0. S. ENVIRONMENTAL PROTECTION AGENCY
SCIENCE ADVISOR* BQA1D
INTEGRATED ENVIBCtHEOTM. MANAGEMENT SUBCOMMITTEE
OPEN MEETING APRIL 24-25, 1986
Thursday, April 24
9jQQ a.m. ....... Opening Remarks
9:15 a.ra. ....... Discussion of the Charge to the
Subcanraittee
9:45 a.m. ....... General Integrated Environmental
Management (IEM) Methodology
10:30 a.m. ....... Break
10:45 a.m. ... General IEM Methodology, Continued
11;45 a.m. ....... Office of Research and Development
Peer Reviews
12sIS p.m. Lunch
1:15 p.m. ....... Applications of the IEM Methodology
o Regional Hazardous Wasta Pilot
Project
3sl5 p.m. ....... Break
3;30 p.m. ....... o Santa Clara Project
5:30 p.m. ....... Recess
Friday, April 25
9:00 a.m Health Scoring Methodology and
Application
11:00 a.m. ....... Break
11:15 a.m Further Discussion of the Subcommittee
Charge
11:30 a,,11 ,, Subcommittee Discussion and Future Plans
12:00 noon .,...., Adjourn
DC. Wyzga
Dr. Yosie
Mr. Beardsley
DC. Gruber
Or. Spitaer
Ms. Deborah Martin
Mr. Keith Hinman
Dr. Sue Perlin
-------
U. S. EWmCNMENTAL PROTECTION
SCIENCE ADVISORY BOARD
Integrated Environmental Management Subcommittee
July 1-2, 1986 Opening Meeting
Location; U. S. EPA Region 3
841 Chestnut Street
Conference Roan 8 A
Philadelphia, Pa. 19107
Tuesday, July 1
9;00 a.m. .... Welccme fron the Regional Office
9:15 a.m. .... Opening Remarks
9:30 a.m* .... Briefing on Planning and Managing
an ISM Study: Philadelphia as a
Case Study
11:00 a.m, .... Break
11:15 a.m, .... Continuation of Philadelphia
IEM Briefing
12jOO noon .... Lundi
1:00 p.m. .... Continuation of Philadelphia
IBM Briefing
2:30 p.m. .... Break
2:45 p.w. .... Methodology for Kanawha Valley Study
4:30 p.m. .... Recess
7s00 p.m. **.. Subcommittee Dinner
Wednesday, Judy 2
•9:00 a.m, .... Further Discussion of the tEM Health
Scoring Methodology and Its Applications
11:00 a.m. .... Break
11:15 a.m Statements from the Public
11:25 a.m. .... Suixomittee Discussion and Future Plans
Mr. James Self
Regional Administrator
£*. Ronald Wyzga
Or. Tarry ¥osie
Mr. Caniel Beards ley
Mr. John Williams
CPFfi
Mr. Greene Jones
Region III
Mr. Daivid Lee
CPPE
Or. Susan Perlin
CPU:
Me. Cragg
Halogenated Solvents
Alliance
from the
Manufacture
Association
-------
U. S* Environmental Protection Agency
Science Advisory Soard
£ntagtaca4 Environmental Management Subcommittee
Open Meeting—September 18-L9, 1986
Thursday, S«pc«nber 18
9:00 am
9:10
9s4S
12;GQ pm
L-;OQ
1:45
3:30
4;30
Friday, September^ 19
9:00 an
9:05
12:00 ?m
L;00
Opening Remarks
Briefing on Objectives of the D*enver
IEM Study
Revlslcacion of Objectives and technical
Design of the Kanawha Valley Study
Lunch
Briefing on EPA Incemal Review of
the Baltimore IEM Study
Subcommittee Discussion of Saltiaor*
and Santa Clara Valley IIM Sttidtw
Subcommittee.Discussion
Recess
Opening Remarks
Of. Wyzga
Mrs. Conway
Mr. Seardsley
Mr, Beardsley
Hr. Jones
Mr. W«ista«fx
Dr. ¥yzga
Mrs.
Further Subcommittee Discussion of the IEM
Health Scoring Methodology
Lunch
Subcommittee Discussion of Preparing a Draft
Seporc and Writing Assignments
3:00
Adjourn
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U, S. ENVIRONMENTAL PROTECTION
SCIENCE ADVISORY BOARD
INTEGRATED ENVIRONMENTAL iytANAGEHE-NT PROGRAM SUBCOMMITTEE
December 4-5, 1986 — Open Meeting •
Location* D. S, Envirorroental Protection Agency
401 M Street, S. w.
North Conference Center, Rocw *3
Washington, D. C. 20460
Thursdayf December 4
9;15 a.ra* ...... Opening Ranarks Dr.
Or, Yosie
9:25 a.m. ...... Report of the Baltimore Working Group Dr. Brown
IQjSQ a.m. ,..t.. Break
1Q;45 a.m. ...... Report of the Santa Clara Working Group Or. Cohen
12:00 noon ...... Lunch
1:00 p.m. ....„, Report o£ the Philadelphia Working Group Dr. Davies
2:00 p.m. ...... Information Briefing on the Denver IEMP Dr. ieart3sley
Project Mr. Napolitano
3:00 p.m. to
5:00 p.m. ,,,»,.. Discussion of Preparing a Subcommittee
Report on the IEMP
* Structure
* Issues
* Strengths and Weakness
* Conclusions
* Recotmendations
.Friday, December 5
9;00 a*m Sunroary of Subccmraittee Findings and
Recatnendations on the Health Scoring
Methodology
10:30 a.m. ...... Break
10:45 a.m. to
2;30 p.m. ...... Continuation of Discussion of Preparing
a Final Report on the IEMP.
2:30 p.m. ...... Adjourn
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U. S, ENVIRDfMENTAL PROTECTION
Science Mvisory Board
Integrated Environmental Management Subcommittee
Open Meeting —— March 16-17, 1987
Location: U. S« Environmental Protection Agency
Region #3
841 Chestnut Street
Conference Koora §8A
Philadelphia, Pa, 19107
Monday, March 16
9:00 a.m. »»»,. welcoming
9:10 a.m. ..,,, Opening Remarks
9:20 a.m. ..... EPA Briefing on the Kanawha Valley
Snvirormental Study
o Overview of the Report
o Objectives
o Methodology
o Results
12 i 30 noon ..... Lunch
1:45 p.m. ..... Subcommittee Review of the Kanawha
to Valley Environmental Study
4:00 p.m,
4:05 p.m , Break
4:15 p.m. ....» Sjbcatmittee Conclusions and
Beccrarnendations
5:00 p.m. ..... Recess
6:30 p.m. ..... Subcommittee Dinner
Tuesday, March 17
9:00 a.m. ..... Executive Session—Discussion of the
to Executive Summary of the Subcommittee's
12i00 noon Draft Report oC the Integrated Environ-
mental Management Progrim
12:00 noon ... *. Lunch
1:15 p.nu ..... Preparation of a Subcommittee Report on the
to Kanawha Valley Environmental Study
3:00 p.m.
Mr. Laskowski, Deputy
Regional Administratoi
Dr. Wyzga
Dr. Yosie
Mr. Napolitano
Mr. Jones
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