UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
Region II, New York, New York 10278
DATE: Dec. 31, 1987
SUBJECT: Risk Assessment Review
FRCM:
i ona
Willi amA. Mu X2/y nski
Depu t y "Reg i onal Administrator
Peter Preuss
Di rector
Office of Regulatory Support and Scientific Assessment
TO: Addressees
Attached is a copy of the Risk Assessment Review, a bimonthly
publication that is a cooperative effort between the Office
of Research and Development and the Regional Risk Assessment
Ne twork.
The Review serves as a focal point for information exchange
among the EPA risk assessment community on both technical
and policy issues related to risk assessment. It is currently
in its second year of publication, and we are pleased at the
positive feedback we've received on the Review's usefulness
to staff across the Agency.
Thanks to all of you who continue to contribute articles
and are involved with production efforts. If you have an
article to contribute or any suggestions for future issues,
contact one of the Committee members listed on page 1 of
the review.
At t achmen t
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December 1987
Highlights
• More on EPA's New Risk Communication
Program p. 1
• Risk Assessment Council and Forum
Activities p. 2
• New Lead Region for Risk p. 3
• Semi-Annual Meeting of Risk Assessors p. 5
I. Special Feature:
MORE ON EPA'S NEW RISK COMMUNICATION
PROGRAM
Improving how we communicate about risk is important
for at least two reasons:
1 The most obvious risks often are not the most serious
ones. We need to help put risks in context so that
people can understand and accept tradeoffs that they or
policy makers have to consider as part of any risk
management decision.
2.Some environmental risks simply cannot be reduced
by using traditional regulatory approaches. We need to
help people understand the other options that exist, so
they can choose their own actions to manage these
risks.
There has been a dramatic rise in the number of
program office and regional activities with explicit risk
communication components. The Office of Policy,
Planning and Evaluation is coordinating a Risk
Communication Program, to be a source of information
to the various groups in the Agency about what is being
learned about effective risk communication. This
coordination includes four main functions: developing
improved methods for communicating risks, facilitating
and evaluating the effectiveness of specific risk
communication efforts, training Agency personnel about
how to communicate risk, and providing outreach
through a hotline and clearinghouse.
The October 1987 issue of Risk Assessment Review
described the problem-specific consulting and analysis
that has been used to determine the effectiveness of
ongoing risk communication activities. This issue covers
methods development. The remaining topics-training
and outreach-will be described in the next two
issues. Anyone who wants more information now can
consult the complete list of risk communication and risk
training projects on the E-Mail Risk Assessment/Risk
Management Bulletin Board. (Once in E-Mail, type
"PRPOST" at the > prompt, and "RISK" when asked
for a category. Occasionally the list is removed for
updating.)
Several questions about how to communicate risk apply
to nearly all of EPA's programs. For example, we know
that many people have trouble understanding risk
expressed in terms of exponents (1x10-6), but what
explanation works best? Compared with our scientists'
estimates, many people tend to understate some kinds
of risk (e.g., for radon in homes) and at the same time
overstate other risks (e.g., for most Superfund sites).
Risk Assessment Review Committee
Peter Preuss - ORD, FTS 382-7669
Tom D'Avanzo - Region I, FTS 835-3222
Maria Pavlova - Region II, FTS 264-1918
Marian Olsen - Region II, FTS 264-5682
Susan Deihl - Region IV, FTS 257-2234
Suzanne Wuerthele - Region VIII, FTS 564-1743
Dana Davoli - Region X, FTS 399-1757
How might we achieve greater consistency between
perceived risks and objective measures of those risks?
Some times we find out about a "new 'risk. If we tell
people that they should be concerned about this risk,
does it displace some other risk from their "worry
budget"? If so, is there some way to predict which risk
is more likely to be displaced?
These questions require a careful research program
before results can be used in actual risk communication
activities. The Risk Communication Research Program
(RCRP) has been set up to explore answers to such
questions. Its objective is to use the best talent to
develop ways to express risks that lead to clear
understanding and appropriate actions.
Some research can be done internally, as in the case of
the May 1987 report on evaluating and improving EPA's
risk advisories. Other research is being conducted
jointly with some of our sister federal agencies. One
example is a summary of the risk communication
literature's implications for practitioners, being written
by EPA and the National Science Foundation. Their
draft is being revised and should be available within two
to three months.
Still other questions are best examined by researchers
at universities and nonprofit organizations, together with
EPA staff through cooperative agreements. The first
step for this portion of the RCRP is consultation with the
program and regional offices to determine which topics
are most important for their risk communication needs.
This information is incorporated in a Request for
Proposals (RFP) describing the Agency's research
needs and anticipated funding levels for each topic. The
first RFP was distributed to a wide group of experts last
February. About 40 proposals were received for seven
topics. The program and regional offices assisted in
reviewing these proposals and often have provided
dollar or managerial resources to help tailor the
research to their needs. Cooperative agreements have
been awarded to those selected by consensus. We plan
to send out a second RFP in December.
The following project list has brief descriptions of
methods development studies that are complete,
ongoing, or proposed. A contact name and phone
number are included, so that you can find out more
about a specific study. For more information on the Risk
Communication Program in general, call its hotline
number, FTS: 382-5606.
PROJECT LIST
Methods Development
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Completed
1. Catalog and evaluation of various agencies' efforts to
use risk advisories (OPPE: OMSE and OPA, April,
1987). (Carol Deck, 475-7399)
Ongoing
2. NSF/EPA examination of risk communication
research results that are relevant to practitioners. Draft
report July 1987. (Derry Allen, 382-4012)
3. Case studies in risk communication, with
accompanying analysis. Tufts University Center for
Environmental Management. Draft November 1987; to
be presented at workshops in January 1988. (ORD
funding, OPPE assisting in management). (Daphne
Kamely, 475-8917, Derry Allen, 382-4012)
4. National Academy of Sciences. The Academy is
conducting a major project on risk perception and
communications. OPPE helped to get it launched and is
following it closely. Report due in 1988. (Derry Allen,
382-4012)
5. Research and guidance on the use of risk
comparisons as a communication tool, using court
cases involving asbestos in schools as a case study
(NSF and OPPE). (Derry Allen, 382-4012)
6. Environmental risks with long latencies or irreversible
consequences. University of California--San Diego is
assisting EPA in examining decision making under
uncertainty, especially decision models (expected and
nonexpected utility maximization) that individuals use to
discount risks over time (conceptual draft received Fall
1987). (Ann Fisher, 382-5500)
7. Evaluate whether the expected amount of life lost
(and other ways of expressing risk, such as the number
of statistical lives lost per year) communicates risk more
effectively than small changes in low probabilities.
Eighteen-month study initiated Summer 1987. (Ann
Fisher, 382-5500)
8. Develop ways to achieve greater consistency
between subjective and objective risks. Twelve-month
study initiated Summer 1987. (Alan Carlin, 382-3354;
Terry Dinan, 382-3354)
Proposed
9. Risk Communication Institute. OPPE has been
advising a consortium of researchers interested in
establishing an institute to study risk communications.
(Derry Alten, 382-4012)
10. Avoiding risk information overload. OTS and
OSWER are particularly interested in how to alert the
public to risks without overwhelming them so that they
reject all risk communication. This could be explored in
the context of OTS communications about
formaldehyde or para dichlorobenzene, or OTS and
OSWER communications about Title III of SARA. (Ann
Fisher, 382-5500)
11. Transferring natural hazards risk communication
lessons for technological hazards. The natural hazards
literature is relatively rich with studies of how risks have
been communicated to affected groups. This research
would explore how this could be applied for
technological environmental risks. (Ann Fisher. 382-
5500, Janice Quinn, 475-8600)
II. From Headquarters
UPDATE ON RISK ASSESSMENT COUNCIL
AND FORUM ACTIVITIES
by Don Barnes
These are items that have grown out of recent meetings
of the Risk Assessment Council.
1. The Risk Assessment Forum Special Report on
Arsenic was reviewed favorably by the Risk Assessment
Council. The report on the carcinogenic risk associated
with the ingestion of inorganic arsenic recalculates the
potency of the chemical based upon more recent data
received from epidemiological investigations in Taiwan.
As a consequence, the unit risk factor has been
decreased by about one order of magnitude.
Upon reviewing the document, the Risk Assessment
Council recommended that . .in view of the following
considerations, that are discussed in the Report:
1. The Taiwanese studies are appropriate for use in
assessing the risk of arsenic-induced skin cancer
2. Only a fraction of the arsenic-induced skin cancers
are fatal.
3. The non-fatal skin cancers remain of some concern.
4. The dose-response curve for the skin cancers may
be sublinear, in which case the cancer potency in this
Report will overestimate the risk.
5. Arsenic may cause cancer in internal organs, a
consideration that is beyond the scope of this Report.
6. Arsenic is a possible, but not proven, nutritional
requirement in animals. There are no direct data on the
essentiality of arsenic in humans.
The Risk Assessment Council recommends that, for
purposes of consistency in Agency risk assessments:
a. Risks of skin cancers associated with the ingestion of
inorganic arsenic be estimated using a cancer potency
(slope factor) of 5 x 10-5
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arsenic-- consistent with the underlying scientific
data base as articulated in the Special Report?"
The SAB review is likely to take place early next year.
2. At its meeting on December 1, the Risk Assessment
Council made the following appointments to the Risk
Assessment Forum:
designing a sampling strategy to generating upper
bound estimates of risk.
PROJECT TO IDENTIFY RISK ASSESSMENT
ISSUES
by Dick Hill
Dr. Roy Smith (Reg. Ill)
Mr. Mike Callahan (ORD)
Dr. Mike Dourson (ORD/Cinc.)
Dr. Donald Barnes (OPTS)
Ms. Elizabeth Bryan (OTS)
Dr. Ila Cote (OAR)
Dr. Lee Mulkey (ORD/Athens)
service through FY'88
service through FY'89
service through FY'89
service through FY'90
service through FY'90
service through FY'90
service through FY'90
In addition. Council Chair John A. Moore appointed the
following to the Council Subcommittee on Ecological
Risks:
Dr. Steven Broderius -- Duluth lab
Dr. Harvey Holm -- Athens lab
Dr. A. Dexter Hinkley -- OPPE
Dr. Foster Mayer - Gulf Breeze lab
Mr. Donald Rodier ~ OTS
Dr. Margaret Rostker - OPTS
Mr. Michael Slimak -- ORD -- CHAIR
Mr. Richard Tucker -- OTS
Mr. Douglas Urban -- OPP
Dr. Bill Williams -- Corvallis
Headquarters staff, including Bill Farland of the Office of
Research and Development, Jeanette Wiltse of the
Office of Air and Radiation and the author from the
Office of Pesticides and Toxic Substances, are
contributing to a project to improve the articulation of
issues in risk assessments to make them more
meaningful to risk managers and the informed public.
The project, being sponsored by the American Industrial
Health Council, draws upon persons from government,
industry, academic and contract institutions to identify
the latest scientific advances and issues that should be
incorporated into risk assessments. The first step is to
identify those attributes which should be part of risk
assessments. The second is to find examples in recent
assessments by government and trade associations that
exemplify these attributes. The third is to interview a
group of risk managers to learn what they consider to
be important risk assessment information in helping to
make regulatory and corporate decisions. A report is
expected in 1988.
III. Around the Regions
Region II
NEW LEAD REGION FOR RISK
3. In recent years a number of Regions and program
offices have generated risk assessments associated
with the consumption of fish containing various chemical
residues. The relationship of these assessments to FDA
authorities on the safety of the interstate food supply
and to State authorities on the safety of sports fishing
within their boundaries has not always been clear.
Therefore, under the auspices of the Risk Assessment
Council a policy position is being generated that
articulates the- responsibilities and roles of the various
governmental entities as they relate to contamination of
fish. This draft document, which has received beneficial
input from several Regions, as well as FDA, has been
discussed with certain members of the Association of
State and Territorial Health Officials (ASTHO). The
intent is to improve the working relationship between the
interested parties.
In a parallel effort, the Council has joined forces with an
on-going Office of Water (Office of Marine and
Estuarine Protection) project to provide information to
the States and the Regions on how EPA goes about
assessing the risks associated with the consumption of
contaminated fish. This includes everything from
On October 20, Deputy Administrator A. James Barnes
announced the transfer of lead region for risk
responsibilities from Region IV to Region II.
At this time, Region II would like to acknowledge the
outstanding accomplishments of Region IV during its
three-year tenure as lead region for risk. Under the
expert leadership of Lee DeHihns and Susan Deihl the
regions have substantially increased their capabilities in
the areas of risk assessment, risk management, and risk
communication. Region IV. in conjunction with the
Center for "Environmental Research Information, the Risk
Assessment Network, and the Risk Training Committee,
established the Risk Assessment Review and also
provided regional input to the Risk Management
Council. Their contributions are greatly appreciated.
Region II plans to continue these initiatives. In addition,
memos have been sent to the Assistant Administrators
and the Deputy Regional Administrators requesting their
ideas on additional areas in which the lead region can
play a role. If you would like to contribute to this effort,
please contact either your Assistant Administrator or
Deputy Regional Administrator.
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The contacts for Risk Assessment in Region II are:
William J. Muszynski, P.E. Deputy Regional
Administrator FTS
264-0396, EPA9201
Assistant Regional
Administrator for Policy
and Management FTS
264-2520, EPA9240
Chief, Policy and
Program Integration
Branch FTS 264-4296,
EPA9243
Environmental Scientist
Policy and Program
Integration Branch FTS
264-5682, EPA9243
Region II looks forward to working with you to ensure
that the programs established by Region IV are
continued and that we are able to meet new challenges
in the areas of risk.
Contact: Marian Olsen, FTS 264-5682.
Region III
A RISK MANAGEMENT SUCCESS STORY
This saga features positive action by a committed local
agency and technical assistance from EPA Region III.
In November 1985, five homes in Allentown, PA had
gasoline vapor infiltration into basement areas. The
Allentown Health Bureau (AHB) investigated possible
sources, suggested remediation activities, and began a
monitoring program. By March 1986, two gasoline tanks
were identified as sources and removed, remediation
measures were completed in several homes, and
monitoring activities had produced a significant body of
exposure data.
The AHB asked EPA Region Ill's Underground Storage
Tank(UST) Program to evaluate the potential health
effects to residents. One of the Regional toxicologists
prepared a formal risk assessment (summarized below)
describing the potential adverse effects and relating
these effects-to both the past exposure and possible
future exposure in these homes.
"Three adverse effects of gasoline vapors have
been considered: fire or explosive hazard, chronic
hydrocarbon systemic toxicity, and benzene-
induced leukemia. A safe level or threshold
exposure was estimated for the fire and explosive
hazard and the hydrocarbon toxicity. Exposures
less than that level or threshold dose will likely not
produce adverse effects. There is no safe dose or
threshold level for leukemia caused by benzene
exposure. However, the risks of leukemia from
benzene in gasoline vapors have been estimated,
both for the past exposure period, and for various
future exposures.
The exposure and risks estimated for the residents
of the five Allentown homes do not represent an
immediate health threat or public health
emergency. However, the levels of benzene do
present an unreasonable future risk of leukemia.
Because of the unacceptable risk of leukemia
posed by future exposure at benzene levels found
in the homes, remedial measures to abate the
gasoline vapor (and hence benzene) levels are
strongly supported."
The toxicologist and a manager for the UST Program
met with AHB professionals and city officials to discuss
these conclusions. The toxicologist met separately with
staff level employees of the AHB to describe the details
of how the risk assessment was prepared. The
toxicologist also met with each of the five families
involved to discuss the cancer risks from the past
exposure to the gasoline vapors.
Monitoring levels in all five homes were at background
after the completion of remediation and removal
activities. Basement levels of measured hydrocarbons
were at the same level as the rest of the house, and
identical with levels in ambient air throughout the
Allentown area.
Contact: Dr. Samuel L. Rotenberg, FTS 597-2842.
CROSS-MEDIA PROJECT
The Region has begun a project to integrate risk into
the process of setting management priorities and
allocating resources. This project is philosophically
similar to the recent Headquarters effort (entitled
"Unfinished Business..."), but will be Regional in scope
and will include risk management recommendations.
Work on the project began in June 1987, when the
Steering Committee established analytical ground rules
and selected a list of 18 environmental problems to be
ranked according to risk. Ranking will consider three
types of risk: (1) to human health, (2) to the
environment, and (3) to welfare (e.g., aesthetic
revulsion, property damage). Three work groups (one
for each type of risk) were selected in November and
have begun to accumulate data.
We anticipate the work groups will rank the
environmental problems by January 1988 and produce
reports by February. EPA employees will be asked to
develop risk reduction initiatives by April. By July, the
Environmental Management Committee will select
initiatives to be implemented under the Region III
MERIT process. Implementation will begin in October,
at the beginning of the fourth year of MERITs.
Contact: Richard M. Fetzer, FTS 597-1196.
Region VI
REGION VI FORMS RISK COORDINATION
COMMITTEE
In response to the growing emphasis on risk
assessment within the Agency, Region VI has formed a
Risk Coordination Committee comprised of
Herbert Barrack
Alice Jenik
Marian Olsen
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representatives from all program areas. The following
purposes of the committee have been identified:
•To encourage staff coordination between program
areas,
•To provide and encourage a forum for information
exchange between EPA programs,
•To coordinate training programs,
•To produce summaries of regional risk assessment
activities,
•To discuss and identify cross-media issues,
•To discuss specific risk assessments which have been
performed,
•To serve as a mechanism to upgrade risk assessment
capabilities in the regional programs.
•To advise regional managers on specific toxics related
issues which have been assigned by senior staff,
•To serve as a focal point for risk coordination with
Region VI, and
•To coordinate, as needed, with ATSDR.
The committee meets once a month, and one of the first
major tasks is coordinating and organizing the regional
risk workshops to be held in 1988. The first risk
workshop will be held January 13 and 14, 1988 and will
be conducted with the assistance of two Headquarters
facilitators. The Region is anticipating training about 30
regional staff in this first course and holding monthly
workshops thereafter using Regional facilitators to train
the remainder of Region VI employees.
Contact: Jill Lyons, FTS 255-7208.
Region IX
SEMIANNUAL MEETING OF RISK ASSESSORS
The second semiannual meeting of regional risk
assessors met in San Francisco on October 21-23,
1987. The major goals of the meeting were to discuss
exposure assessment factors and assumptions, and
regional risk organizational issues and training plans.
During the first day of the meeting various presentations
were made, including a discussion on indoor inhalation
exposures from contaminated water uses by Or. Julian
Andelman, Professor of Water Chemistry, Center for
Environmental Epidemiology, University of Pittsburgh,
Pittsburgh, PA". In addition, ORD's Office of Health and
Environmental Assessment's Exposure Assessment
Group presented its draft Exposure Factors Handbook.
The handbook presentation generated much discussion,
particularly with respect to defining and documenting
the assumptions that were used in the Handbook. While
there was no consensus regarding these factors, most
participants welcomed the publication of the draft
document and plan to use it to document exposure
assessments once it is finalized.
The participants split into workgroups for the remainder
of the meeting to discuss risk issues. The following is a
brief summary of the workgroup discussions.
Water Exposure Factors
The discussion focuses on whether exposure
assumptions should be based on average or
sensitive individuals or both. The workgroups also
discussed the Julian Andelman presentation and
agreed that risk assessments should look at
exposure to air in the entire house from chemicals
volatilized from tap water. Another item discussed
was how can better analytical data be obtained to
support human health risk assessments.
Air Exposure Factors
While no consensus was reached on air inhalation
rates, the general opinion of the workgroup was that
current factor rates are adequate for risk
assessments. In addition, much concern was raised
regarding the lack of inhalation reference doses
(RfD's) in the Integrated Risk Information System
(IRIS). The workgroup felt it was a high priority to
develop the inhalation RfD's and add them to IRIS
as soon as possible.
Soil Exposure Factors
Again, no consensus was reached on specific soil
parameters. The workgroup concluded that soil
pathway analysis should be used in risk
assessments and for calculating cleanup levels. It
was noted that ORD's draft Exposure Factors
Handbook did not have some of the exposure
pathways that are evaluated at hazardous waste
sites. It was. suggested that ORD consider
incorporating some of the factors used in the Office
of Solid Waste and Emergency Response's
"Exposure Assessment Manual" into its draft
Exposure Handbook.
Risk Organizational Issues/Training Plans
Workgroup members agreed that what's working in
the regions includes having a focal point for risk
assessments, establishing interdivisional risk
coordinating committees and setting up regional
expert Grade 13 positions for toxicologists. It was
also recommended that the regions expand the
diversity of their skills mix, e.g., hire more health-
oriented professionals and develop a core
constituency of risk people.
The next meeting is tentatively planned for April or May.
Contact: Arnold Den, FTS 454-0906
IV. Announcements
SCHEDULE FOR RISK AND DECISIONMAKING
COURSES
"Risk and Decisionmaking" is a course that gives
participants a basic understanding of the concepts and
elements of risk assessment, risk management and risk
communication. It blends limited lectures on the
principles of risk assessment and risk communication
and on the Integrated Risk Information System (IRIS)
and the Risk Assessment Guidelines with small group
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discussions based on a hypothetical case study. The
case study was constructed to raise multimedia issues,
and so has application to all programs and to all staff.
The course is being given in Headquarters and in each
Ragtoral Office The following is a schedule through
February 7988.
November 30 - December 1. Headquarters
December 1 - 2:
December 7-8:
December 9-10:
December 15-16.
January 19-20:
January 28 - 29:
January
(dates to be announced):
February
(dates to be announced):
Region V
Region VII
Headquarters
Headquarters
Region VIII
Headquarters
Headquarters
Headquarters
Region VI (2 classes)
Region IX
Region X
Region li
Region VIII
{will include states)
Contact: Pam Stirling, FTS 382-2747
SOCIETY FOR RISK ANALYSIS COURSE
The Society for Risk Analysis will hold its third annual
course, "Carcinogen Risk Assessment" on March 28-
30. 1938, at the Capital Hilton in Washington, O.C. The
course will cover the risk assessment process, the use
of scientific data in risk assessment, risk initiatives in
federal agencies, and risk management. Special
emphasis will be given to new developments in the
areas of biologically based modeling, pharmacokinetics
and biomarkers. Lecturers will be Dr. Roy Albert,
Professor and Chairman, Department of Environmental
Health and Kettering Laboratory, University of
Cincinnati; Or. Elizabeth Anderson, President.
ICF/Clement: Dr. Mark Bashor, Director OHA, Agency
for Toxic Substances and Disease Registry; Dr. Vines
Covello, Director of the Risk Assessment Program,
Nationat Science Foundation; Dr. William Farland,
Acting Director of the Office of Health and
Environmental Assessment, U.S. Environmental
Protection Agency; Dr. Bernie Golds! ain, Professor and
Chairman, Environmental and Community Medicine,
Rutgers Medical School; Dr. Lester Lave, Department of
Engineering and Public Policy, Carnegie-Mellon
University; Dr. Don Matiison, National Center for
Toxicotogical Research; Dr. Suresh Moolgavkar,
Hutchinson Cancer Research Center; Dr. Curtis C.
Travis, Director of the Office of Risk Analysis, Oak
Ridge National Laboratory; Dr. Mimi Yu, Associate
Professor of Research, Department of Preventive
Medicine, University of Southern California; and Dr.
Chris Whipple, Electric Power Research Institute.
Contacts: Dr. Curtis C. Travis. FTS 628-2107 or (615)
576-2107 and Ms. Mary Oran, FTS 624-8438 or (615)
574-8438.
Co/tfacfs:
Jerome Puskin. QAR-Rad.. FTS: 475-9640
Dorothy Patton, ORD, FTS. 382-6743
Dick Hill, OPTS. FTS. 382-2897
Don Barnes, OPTS, FTS. 382-2897
Dean Hill, NEIC, FTS: 778-8138
Marian Olsen, Region II, FTS: 264-5682
Roy Smith, Region ili, FTS: 597-9857
Dave Dolan, Region V, FTS 886-9532
Jill Lyons. Region VI, FTS: 729-9187
Bob Fenemore. Region VII, FTS: 757-2970
Arnold Den, Region IX, FTS: 4S4-0906
If you would like to receive additional copies of this and
subsequent Reviews or to be added to the mailing list,
contact:
CERI Distribution
26 W Martin Luther King Drive
Cincinnati, OH 45268
Need Help?
If your office needs help in finding information or
assistance on a specific risk assessment problem,
you can announce fftaf need on the Risk
Assessment'Risk Management Bulletin Board now
available on E-Mail. Your colleagues from other
offices who have information or advice will tie able
fo contact you vwtft assistance. For assistance in
posting announcements or reading entries on the
Bulletin Board, contact Electronic Mail User's
Support at FTS 382-5639. Your colleagues from
other offices who have information or advice will be
able to contact you with assistance.
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