United States
Environmental Protection
Agency
Office of Research and
Development
Washington DC 20460
EPA/600/R-92/248
January 1993
Environmental
Criteria and
Assessment Office
(ECAO-Cin)
Annual Report
FY92
U S Environmental Protection Agency
Region 5, Library (P! -1-- -' ,
77 W-t Jackson Dou'-,^ i2ih Floor
Chicago, 1L 60604-3530
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TABLE OF CONTENTS
INTRODUCTION/PURPOSE 1
SELECTED PARTICIPATIVE MODEL IMPROVEMENTS TO DATE 1
TIME LINES FOR SCIENTIFIC LEADERSHIP DEVELOPMENT 2
WAYS TO MEASURE CONTINUING SUCCESS 2
RISK ASSESSMENT METHODS - GUIDELINES AND RESEARCH 3
SCIENTIFIC ASSESSMENTS 3
TECHNOLOGY TRANSFER 5
INTERNATIONAL ACTIVITIES 6
INFORMATION MANAGEMENT 7
RESOURCES 8
ECAO-CIN PUBLICATIONS 9
GLOBALIZATION OF RISK ASSESSMENT - THE FUTURE 12
Printed on Recycled Paper
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SCIENTIFIC LEADERS FOR THE 1990s
Introduction/Purpose
ECAO-Cin was a founding laboratory
for risk assessment and science in the
early 1980s. The National Academy of
Sciences (MAS) paradigm published in
the 1983 Red Book became the frame-
work for risk science and decisions.
Since early 1980, EPA has been pioneer-
ing the risk reduction pathways now in
vogue.
ECAO-Cin began a cultural change in
mid-1991 to address the complexities of
risk science and assessment challenges
for the next decade. A cornerstone for
this conscious decision to change is an
organization committed to continual
learning and improvements in leadership
theory and practice. For higher produc-
tivity and more efficient public health
protection, the historical scientific excel-
lence embodied in ECAO-Cin must
continue. It can be argued that these
ends - scientific individualism versus
collaborative leadership - may seem
incompatible, but we resolve that they
are not. To the contrary, we believe it is
essential that they co-exist, build upon
each other, and widen to broaden our
coalition base.
We have adopted the organizational
empowerment techniques of Total Quality
Management (TQM) and the model
offered by Commonwealth Center for
High Performance Organizations, Inc.,
and are utilizing Dr. John Pickering as
our consultant/facilitator.
At this stage, all ECAO-Cin staff
members have been oriented to the
participative model; our leadership group
- System 4 Board - has V/z years
experience with this model and the
general work force has about 6 months
of initial steps.
As expected, the rate of adoption,
acceptance and application of these
value-based approaches to lead more
effectively have been widely variable.
Changes of this type take time and deal
with learned feelings and behaviors.
What is clear is that the investment is
worthwhile so far; initial improvements
seen in attitudes and sharings make
ECAO-Cin a more welcome place to
work, the power of the model is largely
underrated. Productivity gains are
expected to improve geometrically as
experience and skills with our model
increases and accelerates.
Selected Participative Model Improve-
ments to Date
• Customer focus increasing
• Rotating Acting Directorship to include
Branch Chiefs
• Internalization of groups within the
office
• Genuine revaluation of priorities and
resource availability for ECAO-Cin,
OHEA work, IRIS, and Program and
Regional support
• Formulation and adherence to a
vision
• Model introduced to general work
force
• Unity of purpose is a discussed ideal
ECAO-CIN FY92 Annual Report
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Time Lines for Scientific Leadership
Development
This approach began in June 1991;
reached a milestone in June 1992 when
the full work force was introduced to the
process; and we are looking toward a
mid-1993 change in the way we do busi-
ness with our constituencies internally
and externally.
Ways to Measure Continuing Success
We will compare ourselves with other
styles of operating in terms of the quality
of life at ECAO-Cin, and examine the
resource investments needed to achieve
success. We will be the providers of
choice in what we do.
We will account for our contributions
in terms of human lives saved or
improved, and ecologic protection and
preservation using cost effective tools.
We will measure ourselves in terms of
the breadth of the coalitions we build and
the results we achieve through collabora-
tion.
ECAO-CIN FY92 Annual Report Page 2
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Risk Assessment Methods -
Guidelines and Research
ECAO-Cin is a primary laboratory that
develops risk assessment methods for
noncarcinogenic toxicity of single chemi-
cal exposures. The main products are
research publications and Agency
consensus risk assessment guidelines.
ECAO-Cin staff chaired two Agency
guidelines efforts: the first version of
General Quantitative Guidelines for Risk
Assessment of Noncarcinogenicity
Toxicity, and the revision of the Guide-
lines for Risk Assessment of Chemical
Mixtures, previously published by EPA in
1986. These guidelines are written by
committees representing most major
groups in EPA and provide the rationale
for official Agency policy for health risk
assessments and decisions based on
health risk.
Current research on risk assessment
methods for single chemicals includes
several topics, from statistical
approaches (for threshold estimation and
refinements to the Reference dose
method) to broad assessment techniques
(for sludge application and incineration of
municipal solid wastes). Mixtures
methods have focused on toxicologic
interactions between two chemicals and
the use of such information in site- or
mixture-specific estimation. Current
research is on weight-of-evidence
methods for nonadditive interactions and
on quantitative modifications to the addi-
tivity-based Hazard Index. A project with
implications for both single chemicals
and mixtures focuses on improved
methods for using multiple data sets in
quantitative estimates. The results of
this work has impacted the revision of
the Cancer Risk Assessment Guidelines.
When completed, all these methods will
be incorporated into the Agency risk
assessment guidelines.
Scientific Assessments
ECAO-Cin leads the Environmental
Protection Agency (EPA) in the develop-
ment of risk assessments for chemicals
that pollute our nation's waters and soils.
Our laboratory also develops and reviews
risk assessments for chemicals that
contaminate our nation's air and food.
Our clients include (but are not limited to)
all major EPA program offices and all
regions, many state agencies, and
several international organizations.
Major risk assessment activities in
FY92 included the following:
• Review of public comments and re-
evaluation of risk assessments for the
Phase V chemicals under the Safe
Drinking Water Act (SDWA),
• Initiation of noncancer risk assess-
ment for Polychlorinated Biphenyls
(PCBs) for the Clean Water Act
(CWA),
• Development of many risk assess-
ments in support of the Resource
Conservation and Recovery Act
(RCRA),
• Development of 15 reportable quanti-
ties (RQs) in support of the Superfund
Amendments and Reauthorization Act
(SARA),
• Completion of a highly visible case
study for municipal solid waste
combustion (Rutland, Vermont) and
the initiation of another incineration
case study,
ECAO-CIN FY92 Annual Report
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• Completion of a risk assessment
methods document for landfilling of
sewage sludge,
• Initiation of hazard identification
documents for municipal solid wastes
recycling and composting, and
• Initiation of Cooperative Agreement
with Mississippi State University, the
first of its kind - exploring the poten-
tial for human and ecologic risk
assessment through an aquatic
mecososm model.
ECAO-Cin also coordinated EPA's
Integrated Risk Information System
(IRIS) and co-chairs Agency Work
Groups for evaluation of noncancer and
cancer effects. We have discussed 42
Reference Doses (RfDs) and 57
Reference Concentrations (RfCs), and
handled more than 500 comments to
IRIS User Support (IUS). ECAO-Cin's
Superfund Health Risk Technical Support
Center (SFTSC) also successfully
responded to more than 500 requests
from 10 regions and 19 states.
ECAO-CIN FY92 Annual Report Page 4
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Technology Transfer
One important aspect of the efforts of
ECAO-Cin involves technology transfer
and outreach. It is this overall effort that
assists in the interpretation and imple-
mentation of all our efforts. Increased
emphasis is being placed on technology
transfer and in the development of
technology-driven data bases for internal
and external use. ECAO-Cin predicts
much growth in its expanded capabilities
for site- and chemical-specific assistance
at all levels. The technology transfer
activities of ECAO-Cin can be grouped
into three categories:
• Data base development for public
information transfer on risks
• Outreach - national and international
• Consultation/Technical support/assist-
ance on risk assessment science and
its application
Since its establishment, ECAO-Cin has
been a leader in providing technical
evaluations and decisions. Within the
past 2 years, this effort has grown and
become formalized through the operation
of the SFTSC and the IUS, and participa-
tion in the efforts of the Air Risk Informa-
tion Support Center (AirRISC). Each
center was established to provide tech-
nical evaluations on the important risk
assessment activities of ECAO-Cin, the
Office of Health and Environmental
Assessment (OHEA) and EPA. The
SFTSC is one of seven Agency centers
established to provide technical support
to Superfund regional remedial project
managers and on-scene coordinators.
Specifically, the ECAO SFTSC was
established to assist the Superfund
Office in preparing, reviewing, and estab-
lishing short- or long-term health-based
cleanup levels (risk-based) at Superfund
sites and to respond to client requests on
a rapid turnaround basis. Over the past
year, the SFTSC has completed 514
requests for assistance.
The product of this effort is a report
on site- and chemical-specific technical
support/assistance in health/risk assess-
ment by providing the most current or
scientifically defensible risk characteriza-
tion for single compound or mixtures at
Comprehensive Environmental
Response, Compensation and Liability
Act (CERCLA) sites. ECAO-Cin's
SFTSC also has the responsibility for
coordinating with regions, other SFTSCs
and the various superfund offices (such
as the Office of Solid Waste [OSW]) to
ensure that the response provided is
justified in terms of science or program
policy, and that the same techniques are
applied to all National Priority List (NPL)
sites.
ECAO-CIN FY92 Annual Report
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International Activities
ECAO-Cin has always been involved
with global environmental activities and
issues. The primary conduit of such
involvement has been with the Inter-
national Programme on Chemical Safety,
World Health Organization (IPCS/WHO).
ECAO-Cin serves as a focal point for the
Office of Research Development (ORD)
and OHEA scientific interactions with
IPCS/WHO. Efforts have included the
development of health assessments and
documentation for IPCS, which are
distributed worldwide; participation on
expert task forces; and participation in
symposia and training sessions on health
risk assessment. Other international
activities include participation in the
Binational Committee to develop water
quality objectives for the Great Lakes as
part of the International Joint Commis-
sion (IJC) for the Great Lakes and the
Great Lakes Water Quality Initiative
(GLWQI). Over the next several years
we will focus upon followups in the
Agenda 21 agreement at Rio as applied
to global risk assessments.
During FY-92, through our involve-
ment with IPCS, we have successfully
hosted an international task force
meeting to develop health risk assess-
ments for the pesticides benomyl and
carbendazim. Experts from nine
countries representing 11 organiza-
tions/universities met in Cincinnati to
develop environmental and health risk
assessments for these two pesticides.
The guidance documents developed will
be distributed and used worldwide,
particularly in low economic countries.
We have also served as the lead organi-
zation in developing environmental health
criteria documents for malathion and
cresols.
Our participation in international
meetings and committees included the
following:
Dr. Debdas Mukerjee taught a
week-long seminar on effects of
cancer risk assessment at Kiel,
Germany, where he is Adjunct
Professor at the University of Kiel.
Dr. Michael Dourson was invited to
Geneva to assist the IPCS.
Discussions focused on considera-
tion of methods for deriving
guidance values for human
exposure to chemical substances
in the environment. Dr. Dourson
chaired the subgroup on
Uncertainty Factors (UF).
Dr. Terry Harvey visited
Copenhagen, Denmark, to
evaluate and support two WHO
topics for IPCS. These included
Hypersensitivity to Chemicals - An
Updating to the 1992 WHO Report
and Use of Quantitative Risk
Assessments by IPCS/Agenda 21
in Rio.
Dr. Rita Schoeny presented a
paper at the First International
Meeting on Environmental
Mutagens in Human Populations at
Risk in Cairo, Egypt. This meeting
was unusual in its outreach to
African and Middle Eastern
nations.
ECAO-CIN FY92 Annual Report
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Information Management
High quality, reliable human health
risk assessment information, which has
been put into a meaningful and useful
context and communicated to decision
makers, is a significant product for
ECAO-Cin. This information represents
use of the best available science data
and assessment techniques, which
serves as the primary Agency resource
for risk management and regulatory
decisions. Data bases are developed
and used by ECAO-Cin as well as by
other federal agencies, state and local
governments, and several international
organizations and countries. Several
systems are available from ECAO-Cin for
the creation, collection, use, processing
and transmission of this quality informa-
tion. IRIS, MIXTOX and Lead Biokinetic
models are all examples of this Risk
Assessment Communication Network
developed by ECAO-Cin.
Demand for access and availability of
these risk assessment tools has
increased greatly in the past several
years. This especially applies to the IRIS
and MIXTOX data bases. Current
activities for the data bases are high-
lighted below.
• Upgrade/expansion of IRIS informa-
tion to include 50 new chemical-
specific substances, Drinking Water
Health Advisory data, and other infor-
mation
• Upgrade of MIXTOX, software, expan-
sion of references, and distribution of
MIXTOX Version 1.5
• Incorporation of interaction data on
carcinogens into MIXTOX
ECAO-Cin plans to broaden these
activities in the future. For IRIS, future
activities include the development of a
collateral federal system, or initiation of
FTTA agreements for marketing and
distributing IRIS 2. We envision this
system serving as a worldwide model for
the implementation of Agenda 21.
ECAO-CIN FY92 Annual Report
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ECAO-CIN RESOURCES
(Dollars in $K)
Full-Time Equivalent
(FTE)
FY91
40.1
FY92
37.6
FY93
37.7
R&O - Extramural by Media
AIR QUALITY 12.8
WATER QUALITY 255.8
DRINKING WATER 190.3
HAZARDOUS WASTE 623.2
MULTIMEDIA 113.7
RIHRA 155.0
SUPERFUND 1,208.9
SERDP
TOTALS 2,559.7
108.9
231.4
168.6
582.1
113.0
135.0
789.5
800.0
2,928.5
0.0
145.8
681.7
172.7
387.0
0.0
703.1
2,090.3
ECAO-CIN FY92 Annual Report
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ECAO-CIN PUBLICATIONS - FY92
Abstracts
Brady-Roberts. E. 1992. Municipal and
Solid Waste Management.
Choudhurv. H.. S. Griffin and M. Mumtaz.
1991. Risk Assessment of Acetone,
Ethyl Acetate, Ethyl Ether as a Chemical
Mixture.
Cleverly, DM C. Travis and G. Rice.
1992. Demonstration of the U.S. EPA's
Indirect Exposure Chamber Methodology
for Combustors.
Dourson. M.L. J.L Cicmanec and K.A.
Poirier. 1991. Testing a Novel Approach
to Estimate Health Risk Above the Refer-
ence Dose (Rf D/Reference Concentration
(RfC).
Hertzberg. R.C. and LA. Knauf. 1992.
Severity Modeling Instead of a NOAEL
for Noncancer Risk Assessment. Tri-
Service Conference on Applications of
Advances in Toxicology to Risk Assess-
ment, Wright-Patterson Air Force Base,
Dayton, OH. May 1992.
Hertzberg. R.C.. P. Durkin and M^.
Mumtaz. 1992. A Generalized Model for
Defining Additivity for Chemical Mixtures.
Tri-Service Conference on Applications of
Advances in Toxicology to Risk Assess-
ment, Wright-Patterson Air Force Base,
Dayton, OH. May 1992.
Mather, F.J., S.A. Blakley, L.E. White,
A.J. Englande, M.S. Arata, C.N. Correa
and P.A. Murphy. 1992. Sample Size
Estimation in Environmental Epidemio-
logical Studies with Continuous Exposure
Measurements. Presented at Inter-
national Society for Environmental Epide-
miology 4th Annual Meeting,
Cuernacava, Mexico. August 1992. (To
be published in Arch. Env. Health, 1993)
Mumtaz. M.. R. Schoenv and T. Harvey.
1991. The Risk Assessment Process at
the U.S. EPA: Current Guidelines and
Reference Numbers. Tri-Service Confer-
ence on Applications of Advances in
Toxicology to Risk Assessment, Wright-
Patterson Air Force Base, Dayton, OH.
May 1992.
Mumtaz. M. and J. Coleman. 1992. The
Risk Assessment of Chemical Mixtures:
Fine Tuning the Hazard Index. Tri-
Service Conference on Applications of
Advances in Toxicology to Risk Assess-
ment, Wright-Patterson Air Force Base,
Dayton, OH. May 1992.
Mumtaz. M. and P. Durkin. 1992. A
Weight-of-Evidence Scheme for Assess-
ing Interactions in Chemical Mixtures.
Tox. Ind. Health. (In press)
Mumtaz. M.. D.J. Reisman. B. Peirano.
L. Knauf. C. DeRosa, K. Enslein, V.
Gombar and V.M.S. Ramanujam. 1992.
Computer-Assisted Estimation of Chronic
LOAEL Based Upon Quantitative Struc-
ture Activity Relationships. Toxicologist.
12(1): 94. Abstract #289.
ECAO-CIN FY92 Annual Report
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Mumtaz. M.. D.L. McKean, K. Garrahan,
B. Means and D. Davoli. 1992.
Hazardous Waste Site Risk Assessment:
An Illustrative Case Study. Tri-Service
Conference on Applications of Advances
in Toxicology to Risk Assessment,
Wright-Patterson Air Force Base, Dayton,
OH. May 1992.
Mumtaz. M.. K. Poirier and R. Hertzberg.
1993. Feasibility of Developing Target
Organ Toxicity Doses for Estimation of
Toxicity of Chemical Mixtures. Submitted
for Society of Toxicology, March 1993
meeting in New Orleans.
Murphy. P.A. 1992. Quantifying Chemi-
cal Risk from Epidemiologic Studies:
Application to the Disinfectant By-Product
Issue. Presented at The First Inter-
national Conference on the Safety of
Water Disinfection: Balancing Chemical
and Microbial Risks, J.W. Marriott Hotel,
Washington, DC, August 31-Sept. 3.
Patterson. J. and L. Tuxen. 1992. The
Integrated Risk Information System:
Opportunities for Public Input.
Poirier. K.A. and G.L Foureman. 1992.
Development of an Oral Reference Dose
(RfD) for Selenium: Essentiality and
Toxicity Considerations. Toxicologist.
12(1): 248. Abstract #940.
Riley, T.J., J.A. Cauley, P. Murphy and
D. Black. 1992. The Relation of Water
Chlorination to Serum Lipids in Elderly
White Women. Am. J. Epidemiol. 136:
969.
Schoenv, R. 1992. Utilization of
Mutation Assays for Assessment of
Potential Human Health Risk From
Environmental Mixtures. Presented at
IVth European ISSX Meeting - Toxico-
logical Interactions: Relevance of Social,
Environmental and Occupational Factors,
Balogna, Italy, July 3-6, 1992.
Schoenv. R. 1992. Risk Assessment of
Products of Incomplete Combustion.
Presented at 1st International Confer-
ence on Environmental Mutagenesis in
Human Populations at Risk, Cairo, Egypt,
January 19-24, 1992.
Smallwood. C.L. K.M. Schenck and B.W.
Lykins, Jr. 1992. Health Effects Asso-
ciated with Disinfectant By-Products
Formed from Chlorine, Chloramine, or
Ozone. Presented at The First Inter-
national Conference on the Safety of
Water Disinfection: Balancing Chemical
and Microbial Risks, J.W. Marriott Hotel,
Washington, DC, August 31-Sept. 3.
Stiteler, S., W. Melan, LA. Knauf. R,
Schoenv and S. Velazquez. 1992. A
Computer Program for Testing the Statis-
tical Compatibility of Data Sets with a
Common Multistage Model.
Velazquez Tutt. S. and J.T. Du. 1991.
Derivation of the RfD for Manganese. To
be published with Proceedings from the
Workshop on Risk Assessment of Essen-
tial Elements, Herndon, VA, March
10-12, 1992.
ECAO-CIN FY92 Annual Report
Page 10
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Book Chapters
DeRosa, C., M. Mumtaz. H. Choudhurv
and D. McKean. 1992. An Integrated
Approach to Risk Characterization of
Multiple Pathway Chemical Exposures.
Chapter 12. In: Comparative Environ-
mental Risk Assessment, R. Cothem, Ed.
Lewis Publ., Inc., Boca Raton, FL
Mumtaz. M. and R. Hertzberg. 1992.
The Status of Interaction Data in Risk
Assessment of Chemical Mixtures, jn:
Hazard Assessment of Chemicals, Vol. 8,
J.P. Saxena, Ed. Hemisphere Publ.
Corp., Washington, DC. p. 47-49.
Velazquez. S. and K. Poirier. 1991.
Problematic Risk Assessments for
Drinking Water Contaminants: Selenium,
Aldicarb and Nickel, in: Drinking Water
Contamination and Health: Integration of
Exposure Assessment, Toxicology and
Risk Assessment, 1st ed., R. Wang, Ed.
Marcel-Dekker, Inc., New York, NY. (In
press)
ECAO-CIN Assessments Cleared in
FY92
Reportable Quantity Documents (RQs)
for the following:
Aldrin/Dieldrin
m-Cresol
o-Cresol
p-Cresol
N,N-Dimethylformamide
Pentach lorobenzene
Propoxur
Quinoline
Sodium Azide
Thioacetamide
Toxaphene
m-Xylene
o-Xylene
p-Xylene
Health and Environmental Effects
Documents (HEEDs) for the following:
Alachlor
Aniline
1,2-Dichloroethylene (Mixed Isomers)
Phthalic Anhydride
ECAO-CIN FY92 Annual Report
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GLOBALIZATION OF RISK
ASSESSMENT - THE FUTURE
Situation/Future
As a follow-up to the UNCED meeting
in Rio in mid-1992 and the signing of
Agenda 21, ECAO-Cin looks forward to
facilitating equilibrated and regional,
international risk assessment endeavors
in risk science for methods and specific
assessments for chemicals, mixtures,
and biota. Included in this multimedia,
global forum will be the World Health
Organization (WHO), OECD, ICPTS, and
the like. Also the NAFTA environmental
activities will be supported through these
and related efforts.
Future Liaisons with Other Agencies
ECAO-Cin has embarked on a liaison
project with scientists and engineers for
the Federal Highway Association (FHWA)
of the Department of Transportation
(DOT). This is in response to a statutory
mandate, which specifies that'the EPA
and DOT will jointly prepare a report to
Congress on the potential health and
environmental impacts of use of crumb
rubber modifier in asphalt pavement. A
good working relationship with various
sections of the FHWA has been estab-
lished and the briefing paper is being
prepared with input from EPA and DOT.
As requested, a preliminary report to
Congress delineating risk assessment
issues and research needs will be
submitted in June of 1993.
Connections with the Department of
Defense (DOD) are being expanded in
FY93. For the past 2 years, ECAO-Cin
scientists have participated in scientific
conferences on human health risk
assessment sponsored by DOD and held
at the Wright-Patterson Air Force Base in
Dayton, Ohio. The conference this year
will be jointly sponsored by EPA and
DOD with ECAO-Cin. Joint research
plans are being discussed with DOD and
DOT scientists looking towards managing
cleanup of environmentally impaired
federal facilities on a greatest risk basis.
Future Academic Consortium
A recent thrust of ECAO-Cin is the
establishment of an academic consortium
in the area of human health and environ-
mental comparative risk assessment.
The objectives of the consortium are
several.
• A major objective is to open dialogue
with both bench researchers and risk
translators to establish areas of
mutual interest in academia, govern-
ment, and industry.
• A second objective is to provide direc-
tion to mathematical and laboratory
research such that it is useful to risk
assessment; this can be done by
fostering research congruent with our
aims and by involving EPA personnel
in the planning of research programs.
• A third objective is to further educa-
tional opportunities in risk.assessment
by aiding in the design and teaching
of courses in risk assessment.
The relationship with Universities will
provide entrees to EPA staff for career
growth, i.e., finishing a degree, taking a
postdoctoral traineeship, or doing a
sabbatical or some other kind of labora-
tory residence project and thus keep risk
assessors in tune with other research
activities.
ECAO-CIN FY92 Annual Report
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