EEA/iQQ/N-93/pl9
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
Region II, New York, New York 10278
DATE: October 29., 1993.
SUBJECT: Risk Assessment Review
FROM: William J.^W^zynstoj^VTE.
Deputy Regional Administrator
William Farland, Ph.D. / / /ft,
Director ^X^Cx^c (//C
Office of Health and Environmental Assessment
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
Network.
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 fourth 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 further issues, contact
one of the Committee members listed on page 1 of the Review.
Attachment
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Risk Assessment Review
September 1993
Highlights
• Workshop Report on Developmental Neurotoxicity and
PCBs p. 1
Ecological Risk Assessment Case Studies Report p. 1
Integrated Risk Information System Highlights p. 2
• International Risk Training in Australia p. 4
I. Special Features
Risk Assessment Forum Activities
by Clare Stine (202) 260-6743
Two recent Risk Assessment Forum (RAF) publications
are highlighted below. These reports are now available
from the publication office of the Office of Research and
Development (ORD) in Cincinnati, Ohio.
Workshop Report on Developmental Neurotoxic-
ity and PCBs
On September 14 and 15, 1992, the U.S. Environmental
Protection Agency's (EPA's) Risk Assessment Forum spon-
sored a workshop on the developmental neurotoxic effects
Risk Assessment Review Committee
BUI Farland - ORD, (202) 260-7317
Maureen McClelland - Region I, (617) 565-4885
Maria Pavlova - Region II, (212) 264-7364
Marian Olsen - Region n, (212) 264-5682
Suzanne Wuerthele - Region VIII, (303) 293-1714
Dana Davoli - Region X, (206) 553-2135
of polychlorinated biphenyls (PCBs). The meeting was
held in Research Triangle Park (RTP), North Carolina, and
was chaired by Dr. Linda Bimbaum, RTP, and Carole
Kimmel, Office of Health and Environmental Assessment,
of the EPA. Participants from academia, industry, and state
and federal government brought expertise from a wide
range of disciplines to the discussion. Carole Braverman of
Region V prepared one of the papers for workshop discus-
sion.
The purpose of this workshop was to arrive at a general
"sense of the meeting" on risk assessment issues,
(see Workshop, p. 2)
Ecological Risk Assessment: Case Studies Report
A recently published report uses case studies to explore the
relationship between the process of ecological risk assess-
ment and common approaches used by EPA (and others) to
evaluate adverse ecological effects. The case studies repre-
sent a wide range of ecosystem types (aquatic, wetlands,
terrestrial), ecological scales (individual through commu-
nity), spatial scales (site-specific through national), and
Agency programmatic approaches (CERCLA/SARA, CWA,
CAA, MSPRA, NEPA, and FTFRA).
Ron Landy, Office of Science, Planning, and Regulatory
Evaluation of the Office of Research and Development, led
the Agency work groups that prepared the case studies.
Scientists from seven regional offices, four EPA laborato-
ries, and two program offices actively contributed to this
effort. Participants serving as work group members sug-
gested cases for study and peer review and were authors or
coauthors of 9 out of 12 case studies.
Each case study was evaluated at a peer review workshop.
The external reviewers evaluated each case study on whether
they (1) effectively addressed generally accepted compo-
nents of an ecological risk assessment: problem formula-
tion, analysis, and risk characterization, or (2) addressed
some but not all of these components, or (3) provided an
alternative approach to assessing ecological effects. Case
study strengths and limitations are identified in the report
Some of the themes that emerged from these diverse case
studies are highlighted below:
Discussions between the risk assessors, risk managers,
and relevant experts are critical both at the beginning
and end of an ecological risk assessment.
More attention should be paid to the initial planning
stages of the assessment (problem formulation). The
ecological values to be protected should be carefully
considered and clearly identified.
• While ecological exposure and effects models were
useful, sensitivity analyses and validation studies were
frequently insufficient to evaluate the relevance of the
models to "real world" situations. (See Risk, p. 2)
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Workshop (continued from p. 1)
principles, and research recommendations regarding neuro-
toxic effects associated with prenatal and perinatal expo-
sure to PCBs. Because PCBs are present in air, water, and
food, information developed at the workshop will assist the
Agency in evaluating the effects of PCBs in these media.
Recent studies in rodents and monkeys have demonstrated
that prenatal and perinatal PCB exposure results in neuro-
toxicity in the offspring. Related effects have been reported
in human studies. For example, human poisonings (Yusho
and Yucheng) have led to developmental delays and im-
pairment in neurobehavioral indices in offspring of exposed
women. Also, relatively low levels of exposures to PCBs in
cohorts in Michigan and North Carolina have suggested
neurobehavioral deficits in infants and young children.
Thus, information relating to the public health consequences
of exposure to developmental neurotoxicants such as PCBs
warrants careful investigation.
These observations pose several questions regarding the use
of PCB data for assessing risk of neurotoxic effects because
of prenatal or perinatal exposure:
Are all PCBs alike in these effects, or, if not, are any
useful structure/activity relationships discernable?
What are the dose/response relationships?
• Are some populations at special risk due to elevated
exposure or to inherent sensitivity?
• What are the endpoints of greatest concern and of
greatest sensitivity?
These questions are important because of the persistence of
PCBs in environmental media such as water and air, and the
nature of the data available on PCBs and developmental
neurotoxicity; i.e., many studies are available on various
mixtures, but little or no information is available regarding
specific congener effects on the developing organism or the
mechanism of action of PCBs.
A workshop report entitled, "Workshop Report on Devel-
opmental Neurotoxic Effects Associated with Exposure to
PCBs," is available. The report outlines principles and JJ. Headquarters
methods for evaluating data from animal and human stud-
ies, and summarizes the data and other information avail-
able for characterizing risk to human development, growth,
survival, and function following exposure to PCBs prena-
tally or to infants and children.
For additional information contact Carole Kimmel from the
Office of Health and Environmental Assessment, U.S. EPA,
401 M Street, S.W., Washington, D.C. 20460; telephone
(202)260-7331.
Risk (continued from p. 1)
Field studies provided a level of realism not readily
attainable in laboratory studies, but multiple stressors
frequently made it difficult to identify a particular
stressor as the cause of observed ecological effects.
Finding a suitable reference site for comparison against
a potentially impacted area was also difficult.
• The case studies varied widely in their approaches to
presenting the results of an assessment, although for
chemical stressors, relatively simple comparisons be-
tween point estimates of exposure and effect levels
were common.
The varied approaches used in the case studies are generally
consistent with some (but not all) of the principles in EPA's
Framework for Ecological Risk Assessment (Framework
Report, EPA/630/R-92/001), although this report was not
available when the case studies were prepared. These case
studies and others now being developed will be used along
with the Framework Report and a series of technical issue
papers to provide a foundation for future Agency-wide
guidelines for ecological risk assessment sponsored by the
Risk Assessment Forum.
The case studies report is available from the ORD Publica-
tion Office, Center for Environmental Research Informa-
tion, 26 West Martin Luther King Drive, Cincinnati, Ohio
45268; telephone (513) 569-7562; FAX (513) 569-7566.
Provide your name and mailing address and request the
document, "A Review of Ecological Assessment Case Stud-
ies from a Risk Assessment Perspective," EPA/630/R-92/
005.
For additional information contact Bill van der Schalie,
Risk Assessment Forum, Office of Research and Develop-
ment, U.S. EPA, 401 M Street, S.W., Washington, D.C.
20460; telephone (202) 260-4191.
Integrated Risk Information System Highlights
by Patricia Daunt (513) 569-7596.
To obtain a copy of the report, contact the ORD Publication
Office, Center for Environmental Research Information, 26
West Martin Luther King Drive, Cincinnati, Ohio 45268;
telephone (513) 569-7562; FAX (513) 569-7566. Provide
your name and mailing address and request the document,
"Workshop Report on Developmental Neurotoxic Effects
Associated with Exposure to PCBs," EPA/630/R-92/004.
Supplementary data (chemical/physical properties) will be
removed from ERIS by January 1, 1994. Due to the small
percentage of files with supplementary data, we feel it is not
efficient to continue supporting this section. The user is
referred to other databases, such as the Hazardous Sub-
stances Data Bank (HSDB), for this type of information.
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Summarized below are the IRIS highlights for the months
of July, August, and September. More detailed NEWS is
available for IRIS2 users on the first screen of the system.
July 1993
Oral RfD Noted as Pending Change:
Boron; CASRN 7440-42-8
August 1993 Update
Oral RfD Withdrawn:
Thallium selenite; CASRN 12039-52-0
Oral RfD Noted as Pending Change:
Acetone; CASRN 67-64-1
Inhalation RfC Withdrawn:
Methyl ten-butyl ether (MTBE); CASRN
1634-04-4
Name Change:
Thiophenol; CASRN 108-98-5, which is currently
under review, has been changed to Benzenethiol;
CASRN same
September 1993 Update
. Oral RfD Added to IRIS:
Acetochlor; CASRN 34256-82-1
Oral RfD Replaced (previously withdrawn):
Simazine; CASRN 122-34-9
Inhalation RfC Replaced (previously withdrawn):
Methyl ten-butyl ether (MTBE); CASRN
1634-04-4
Carcinogenicity Assessments Noted as Pending Change:
Benz[a]anthracene; CASRN 56-55-3
Benzo[a]pyrene; CASRN 50-32-8
Benzo[b]fluoranthene; CASRN 205-99-2
Benzofkjfluoranthene; CASRN 207-08-9
Chrysene; CASRN 218-01-9
Dibenz[a,h]anthracene; CASRN 53-70-3
1,3-Dichloropropene (Telone II); CASRN 542-75-6
Indeno[l,23-cd]pyrene; CASRN 193-39-5
As of September 1, 1993, IRIS contained 512 chemicals.
This included 343 oral reference doses (RfDs), 80 inhala-
tion reference concentrations (RfCs), and 216 carcinogenic-
ity assessments, bringing the total number of risk information
assessments to 639. In addition, IRIS also contained 75
Drinking Water Health Advisories, 388 EPA regulatory
action sections, and 95 supplementary data sections (chemi-
cal/physical properties).
For additional information, contact Patricia Daunt, IRIS
Data Base Manager at (513) 569-7596.
. Regions
Region II
HHS Bibliography on Effects of Environmental
Tobacco Smoke
The Office of Smoking and Health of the Department of
Health and Human Services has published "Environmental
Tobacco Smoke in the Workplace: A Selected Bibliogra-
phy." For copies of the publication write to the Office on
Smoking and Health, Communications Branch Technical
Information Center, 4770 Buford Highway, MSK-50, At-
lanta, Georgia 30341-3724.
ATSDR/National Governor's Association Report
on Closed and Restricted Toxic Sites
The National Governor's Association, through a coopera-
tive agreement with the Agency for Toxic Substances and
Disease Registry, has released a report titled "Restrictions
Imposed on Contaminated Sites: A Status of State Ac-
tions." Information on the survey and copies of the report
are available from Barbara Wells, Senior Policy Analyst,
National Governor's Association, 444 North Capitol Street,
Washington, D.C. 20001; telephone (202) 624-5822; FAX
(202)624-5313.
(Excerpted Morbidity and Mortality Weekly Report, Sep-
tember 24,1993).
>• Contact: Marian Olsen (212) 264-5682
Region IX
California EPA Health Risk Assessment Guid-
ance for Hazardous Waste Incinerators
The California Environmental Protection Agency (Cal/EPA)
recently published a guidance document on Health Risk
Assessments for Hazardous Waste Incinerators. This docu-
ment incorporates risk assessment guidance and policies
from OSWER, ORD, Region IX, and various offices in
Cal/EPA (e.g., Air Resources Board, Office of Environ-
mental Health Hazard Assessment, and Department of Toxic
Substances Control) into an integrated guidance for assess-
ment of human health risks from hazardous waste incinera-
tors. The basic format stipulated by Cal/EPA is the format
set forth in the Risk Assessment Guidance for Superfund
(RAGS). The intent of the new document is to expand upon
specific issues in RAGS that are especially important to
hazardous waste incinerators and to provide guidance for
some issues not covered in RAGS.' The general approach
outlined by Cal/EPA is a multipathway risk assessment that
addresses both direct and indirect exposures. This approach
is one that risk assessors in Cal/EPA's Hazardous Waste
Toxicology Section and Region DCs Alternative Technol-
ogy Section have been following for several years.
Contact: Arnold Den (415) 744-1018
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Cal/EPA Risk Numbers
In California, risk assessors not only have to be aware of the
U.S. EPA cancer slope factors (CSFs) and unit cancer risks,
but they also have to deal with CSFs generated by the
California EPA (Cal/EPA). Recently, Cal/EPA increased JV. Meetings
the number of CSFs. This has generated increasing ques-
tions to Region IX concerning which values should be used
and what are the differences. As a result, Region IX con-
ducted an analysis of the CSFs to determine if there were
any significant differences between the values and whether
any of the differences were of regulatory interest.
Risk Assessment Practices. Proceedings of the panel dis-
cussion are to be published.
»• Contact: Alvin Chun (415) 744-1019'
Annual American Public Health Association
Meeting—October 24-28,1993, in San
Francisco, California
The analysis indicates that Cal/EPA has developed 218
CPFs to date, of which 131 have no U.S. EPA values. For
the remaining 87 chemicals, 51 have Cal/EPA and U.S.
EPA values within a magnitude of two of each other; 22 of
the Cal/EPA CPFs are at least two-fold more stringent than
the U.S. EPA values, while 14 of the U.S. EPA values are
more stringent than the Cal/EPA values.
>• Contact: Arnold Den (415) 744-1018
International Risk Training in Australia
Last May, Arnold Den and Alvin Chun of the Region DC
Regional Administrator's Office were invited by the Aus-
tralia and New Zealand governments to conduct EPA Work-
shops on Risk and Decision Making and Risk
Communication and Public Involvement in Wellington,
New Zealand; and Melbourne and Sydney, Australia. The
groups involved in the workshops included the New Zealand
Ministry for the Environment, the Australian National Task
Force on Hazardous Industries and Land Use Safety Plan-
ning, and a combined group of academic, public and private
sector representatives of Australia. The training especially
on risk communication and public involvement was ex-
tremely well received. The Region IX representatives learned
that the demand for risk communication and chronic human
health risk assessment training is receiving greater attention
in Australia since hazardous waste sites and hazardous
waste generators are becoming public issues. To date, Aus-
tralia and New Zealand have been more concerned with
sudden chemical releases and catastrophic events (rather
than chronic human health risk assessment) related to in-
dustrial land use management.
As a result of the favorable response by Australia for EPA's
Risk Communication and Public Involvement Workshop,
Arnold Den, Bruce Macler (Water Management Division)
and Alvin Chun have been invited by the Australian Water
and Wastewater Association and the Health Department of
Western Australia to conduct EPA's "Risk Communica-
tion," "Risk and Decision Making," and "Ecological Risk
Assessment" workshops in Sydney and Perth this Novem-
ber. They have also been invited to participate in a one-day
panel discussion on International Human and Ecological
The Annual American Public Health Association meeting
was held October 24-28,1993, in San Francisco, California.
The theme of this year's meeting was "Building Healthy
Environments: Physical, Economic, Social, and Political
Challenges." The meeting included more than 1,200 scien-
tific sessions, plenary and special sessions, workshops,
films, poster sessions, lectures, and exhibits. For further
information contact the American Public Health Associa-
tion, Meeting Registrar, Dept 5037, Washington, D.C.
20061-5037; telephone (202) 789-5600; FAX (202)
789-5661.
Lead Tech '93—-October 27-29,1993, in
Washington, D.C.
"Lead Tech '93: New Strategies for an Emerging Industry"
was held October 27-29,1993, at the Omni Shoreham Hotel
in Washington, D.C. The meeting was sponsored by the
American Industrial Hygiene Association and other organi-
zations. For additional information contact the Lead Tech
'93 hotline at (800) 394-0115.
U.S. EPA Health Effects Research Laboratory
Symposium—Biological Mechanisms and
Quantitative Risk Assessment: From
Experimental Design to Risk Management—
November 1-4,1993
The U.S. EPA Health Effects Research Laboratory in Re-
search Triangle Park, North Carolina, will hold a sympo-
sium tided "Biological Mechanisms and Quantitative Risk
Assessment: From Experimental Design to Risk Manage-
ment" November 1-4, 1993, in Research Triangle Park,
North Carolina.
For additional information on the meeting and posters,
contact Research and Evaluation Associates, Inc., 100 Europa
Drive, Suite 590, Chapel Hill, North Carolina 27514; tele-
phone (919) 968^961; FAX (919) 967-4098.
Eighth National Conference on Chronic
Disease Prevention and Control—November
17-19,1993, in Kansas City, Missouri
The CDC, the Association of State and Territorial Health
Officials, and the Association of State and Territorial Chronic
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Disease Program Directors will cosponsor the Eighth Na-
tional Conference on Chronic Disease Prevention and Con-
trol titled "The Role of Chronic Disease Prevention and
Control in a Changing Health Environment." The confer-
ence will be held November 17-19, 1993 in Kansas City,
Missouri. For additional information on the conference
contact the CDC's National Center for Chronic Disease
Prevention and Health Promotion, Mailstop K-43, 4770
Buford Highway, N.E., Atlanta, Georgia 30341-3724; tele-
phone (404) 488-5390; FAX (404) 488-5962.
Healthy Cities Conference—December 8 -11,
1993
The International Healthy Cities and Communities Confer-
ence will be held December 8-11, 1993, in San Francisco,
California. The theme for the conference will be "Improv-
ing the Quality of Life."
For more information contact Dr. Leonard Duhl, Chair,
International Healthy Cities and Communities Conference,
2151 Berkeley Way, Annex 11, Third Floor, Berkeley,
California 94704; telephone (510) 540-2960; FAX (510)
540-3472.
ASTM Fourth Symposium on Environmental
Toxicology and Risk Assessment:
Transboundary Issues in Pollution-Air,
Surface, and Groundwater—April 10-12,1994
The ASTM has requested papers for the Fourth Symposium
on Environmental Toxicology and Risk Assessment:
Transboundary Issues in Pollution-Air, Surface, and Ground-
water. The symposium, sponsored by ASTM Committee
E-47 on Biological Effects and Environmental Fate, will be
held April 10-12, 1994, in Montreal, Quebec, Canada, in
conjunction with the April 12-14,1994, standards develop-
ment meetings of Committee E-47.
Box 709, Pendleton, South Carolina 29670; telephone (803)
646-2237; FAX (803) 646-2277;. or contact the co-chairman,
Dr. Edward E. Little, U.S. Fish and Wildlife Service,
NFCRC, Route 1, Columbia, Missouri 65201; telephone
(314) 875-5399; FAX: (314) 876-1896.
First International Symposium on Ecosystem
Health and Medicine—June 19-22,1994, in
Ottawa, Canada
The First International Symposium on Ecosystem Health
and Medicine, "New Goals for Environmental Manage-
ment," will be held June 19-22, 1994, at the Ottawa Con-
gress Center, Ottawa, Ontario, Canada. This emerging
transdisciplinary field bridges the social, health, and eco-
system sciences in fostering new systemic methodologies
for the diagnosis, prognosis, and treatment of ecosystems
under stress.
The symposium is organized by the International Society of
Ecosystem Health and Medicine and the University of
Guelph. For more information on the meeting contact Mr.
Remo Petrongolo, Symposium Manager, Office of Con-
tinuing Education, 159 Johnston Hall, University of Guelph,
Guelph, Ontario, Canada NIG 2W; telephone (519)
824-4120, ext 3064; FAX (519) 767-0758.
VII International Congress of Toxicology—
July 2-6,1995
The Seventh International Congress of Toxicology (ICT
VII) will be held in Seattle, Washington, July 2-6, 1995.
The program will be based on the theme, "Horizons in
Toxicology: Preparing for the 21st Century." The meeting
will be hosted by the Society of Toxicology in conjunction
with the International Union of Toxicology.
For more information contact ICT/VII, c/o Society of Toxi-
cology, 1101 14th Street, N.W., Suite 1100, Washington,
D.C. 20005-5601; telephone (202) 371-1393; FAX (202)
371-1090.
The objective of the symposium is to provide a forum for
reporting the results of original research and for evaluating
current issues in the assessment of biological effects and
chemical fate. Of particular interest are papers addressing
the regional approaches to risk assessment problems and
solutions in international aspects of pollution assessment,
and issues of chemical fate and biological effects common
across borders. The symposium will begin with keynote
speakers from Canada, Mexico, and the United States pre-
senting discussions of international aspects of contaminant
transport, fate, and effects.
Risk and Decision-Making Course Schedule
The following is the schedule for the Risk and
Decision-Making Courses through December:
October 18-20
November 8-10
November 11*
November 15-16*
November 16-17
November 18-19
Long Beach, California
Sydney Australia
Sydney, Australia
Perth, Australia
Washington, D.C. (EPA - HQ)
Perth, Australia
For more information on the symposium contact the chair-
man. Dr. Thomas W. La Point, Clemson University, P.O.
* Introduction to Ecological Risk Assessment developed
by Region IX.
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The following is the schedule for the Risk Communication
Workshops through December
October 26-27
November 15-17
November 18
December 14-15
Washington, D.C. (EPA - HQ)
Perth, Australia
Perth, Australia
Washington, D.C. (EPA - HQ)
>• Contacts: Jim Cole (202) 260-2747
Marian Olsen (212) 264-5682
Alvin Chun (415) 744-1022
Contacts:
Jerome Puskin
Linda Tuxen
Dorothy Patton
Dick Hill
Don Barnes
Dean Hill
Maureen McClelland
Marian Olsen
Jeffrey Burke
Elmer Akin
Milt Clark
Jon Rauscher
Mary Rouse
Suzanne Wuerthele
Arnold Den
Dana Davoli
OAR-RAD
ORD-OHEA
ORD-RAF
OPTS
SAB
NEIC
Region I
Region II
Region III
Region IV
Region V
Region VI
Region VII
Region VIII
Region IX
Region X
(202) 260-9640
(202) 260-5949
(202) 260-6743
(202) 260-2897
(202) 260-4126
(202)776-8138
(617) 565-4885
(212) 264-5682
(215) 597-8327
(404) 347-1586
(312)886-1918
(214)655-8513
(913) 551-7415
(303) 293-0961
(415)744-1018
(206)442-2135
If you would like to receive additional copies of this and
subsequent Reviews or be added to the mailing list, contact
26 West Mania Luther)
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