- -€^600/^92/003
UNITED STA'TES ENVIRONMENTAL PROTECTION AGENCY
Region II, New York, New York 10278
DATE: February 21, 1992
SUBJECT: Risk Assessment Review
FROM:
William J. UtTszyhs
Deputy Regional A
.E.
nistrator
/"^
William Farland, Ph.D.
Director
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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February 1992
Highlights
Water Issues in the Midwestern States p. 1
Risk Assessment Forum Update p. 1
Region IX Risk Training Activities > p. 4
I. Special Features
Water Issues in the Midwestern States
by: Bob CantaU,FTS 260-7571
Ed Ohanian, FTS 260-7571
State and regional regulators met at the Region V facilities
in Chicago, Illinois, from November 6 to 8, 1991, for the
biannual Federal-State Toxicology and Risk Assessment
Committee (FSTRAC) meeting. Over the course of 2 1/2
days, the group discussed water issues relevant in the
midwestern states, such as fish consumption advisories,
pesticides in surface waters, and standard setting for ground-
water protection; state representatives also considered the
merits of taking taste and odor into account when setting
action levels for gasoline and fuel oil contamination of
drinking water, and the proposed standard for radon in
public water supplies.
FSTRAC is expanding its scope with the reorganization of
the Office of Water to consider issues other than drinking
water contamination. Most of the state representatives and
Risk Assessment Review Committee
Bill Farland - ORD, FTS 260-7317
Maureen McClelland - Region I, FTS 835-4885
Maria Pavlova - Region II, FTS 264-7364
Marian Olsen - Region H, FTS 264-5682
Suzanne Wuerthele - Region VIII, FTS 330-1714
Dana Davoli - Region X, FTS 399-2135
some of the regional FSTRAC members work in areas other
than drinking water every day. Their experience will help
the Office of Water's Office of Science and Technology
begin to address other issues, such as developing method-
ologies for deriving ambient water, sediment, biological,
and wildlife criteria.
The FSTRAC Toxicology and Risk Assessment Subcom-
mittee formed a work group to develop an issues paper that
will consider methods for conducting risk assessments for
shorter-than-lifetime exposures to carcinogens. The sub-
committee will also continue its successful teleconference
series with a session in February. A second issues paper or
strawman protocol developed by the Contaminant Policy
and Communications Subcommittee will help states in ad-
vising private well owners when contamination is found in
their water. FSTRAC members reviewed a draft protocol
for responding to wellowners' requests for information (see
see Water p.2
II. Headquarters
Risk Assessment Forum Update
by Clare Stint, FTS 260-6743
The Risk Assessment Forum report, "Alphas-globulin: As-
sociation with Chemically Induced Renal Toxicity and
Neoplasia in the Male Rat," provides Agency-wide guid-
ance for evaluating renal tubule tumors in the male rat
According to this forum report, risk assessment approaches
generally assume that a chemical producing tumors in labo-
ratory animals is a potential cancer hazard to humans. For
most chemicals, including many rodent kidney carcinogens,
this extrapolation remains appropriate. The report describes
scientific conditions, however, under which the Risk As-
sessment Forum advises EPA risk assessors against using
information on certain renal tubule tumors or nephrotoxicity
to assess human risk. In this situation, the chemical induces
accumulation of the protein alphas-globulin (alpha^-g) in
the proximal tubule of the male rat kidney, initiating a
sequence of events, specific to the male rat, that appears to
lead to renal tubule tumor formation. This EPA policy
against use of a particular animal tumor under certain
circumstances for risk assessment purposes is an important
departure from EPA's general approach to cancer risk as-
sessment
The forum report stresses the need for full scrutiny of a
substantial set of data to determine when it is reasonable to
presume that renal tumors in male rats are linked to a
process involving alpha^-g accumulation and to select ap-
propriate procedures for estimating human risks under such
circumstances. Details of the analysis can be found by
referring to the Risk Assessment Forum report. •
On November 13 and 14, 1990, EPA's Risk Assessment
Forum assembled a peer review panel of experts to discuss
four major topics analyzed in a draft of the report, "Alphas-
globulin: Association with Chemically Induced Renal Tox-
icity and Neoplasia in the Male Rat" These subjects included
alpha^-g and nephrotoxicity, renal cancer, criteria for dis-
tinguishing renal carcinogens that induce alpha^-g accumu-
lation from other renal carcinogens, and risk characterization.
The workshop report entitled "Report of the EPA Peer
Review Workshop on Alphas-globulin: Association with
Renal Toxicity and Neoplasia in the Male Rat," highlights
see Forum p. 4
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Water (continued from p. 1)
Current Hot Issues, p. 3). That subcommittee is also devel-
oping a method for getting the popular "Summary of State
Drinking Water Standards and Guidelines" on-line.
Region V
Region V is dominated by Great Lakes issues. Public water
systems in the region face several issues, including natu-
rally occurring contaminants such as radium, intermittent
nitrate problems, and the impending problems posed by
zebra mussels. The freshwater mollusks are moving from
the lakes into source water, causing a problem in industrial
and drinking water treatment system intakes.
Region V encompasses 41 percent of the total noncommunity
water systems in the country. Traditional enforcement does
not work to bring these systems into compliance with the
myriad of regulations applicable, so several mobilization
and outreach efforts are underway in the region to provide
information to the operators. In addition, resource shortfalls
in the states are a major issue for the region, as some states
may not retain primacy to administer their own drinking
water and permitting programs.
The Region V Office of Health and Environmental Assess-
ment described research into the risks to human health from
consuming contaminated fish, and the Assessment and Re-
mediation of Contaminated Sediments (ARCS) Program
initiated under the Clean Water Act Amendments. An
interagency group including representatives from the Corps
of Engineers, the Fish and Wildlife Service, and the U.S.
EPA will demonstrate advanced technologies at five haz-
ardous waste sites around the region and use lessons learned
while mapping and assessing the sites to develop guidelines
for use at other contaminated sites.
Illinois. A representative from the Illinois EPA described
the state's fish contaminant monitoring program, in exist-
ence since 1977. The objectives of the program are to:
• investigate the presence of toxics in fish to assess
impacts on fish, public health, aquatic environ-
ments, and aquatic communities; and
• locate sources of discharges and evaluate long-
term effects of source control efforts.
The program was established to promote consistency in
methods among state departments and laboratories. Analy-
sis of the results over the past 14 years shows that PCB
levels in Lake Michigan have decreased and finally leveled
off at or below the FDA action level. There are new
problems to replace the older ones, however mercury and
pesticides, especially chlorpyriphos, pentachlorophenol, and
trifluralin, are showing up in rivers around the state.
FSTRAC representatives also heard about Illinois' Ground
Water Standards Program. Under the standards program,
state ground water is classified into one of four categories,
or a ground-water management zone. The categories are:
Class I (potable resource ground water), Class II (general
resource ground water), Class III (special resource ground
water), and Class IV (other ground water). The ground-
water quality standards provide for reclassification of any
ground water as a result of an adjusted standard proceeding
before the Illinois Pollution Control Board, nondegradation
of ground-water resources, establishment of a ground-water
management zone, and alternative standards for areas around
landfills and mining operations and sites undergoing cor-
rective action. The classification scheme, the standards, and
the Health Advisory process also are used to determine
cleanup recommendations at hazardous waste sites.
Michigan. The Michigan Department of Public Health's
(DPH's) risk assessment methods are similar to EPA's, but
when faced with a contaminant problem that has not been
addressed by EPA in a Maximum Contaminant Level (MCL),
Health Advisory, Integrated Risk Information System (IRIS),
or Health Effects Assessment Summary Table, DPH will
derive its own risk-based number. The DPH representative
described a risk assessment performed for t-butyl alcohol
that used an Occupational Safety and Health Administra-
tion Threshold Limit Value to calculate a provisional drink-
ing water guideline (920 parts per billion) that will apply for
1 year. In a second example, he presented a risk assessment-
derived provisional drinking water guideline (150 parts per
billion) for tetrahydrofuran. In yet another case, the DPH
was asked to assess workers' and customers' inhalation and
dermal exposure to perchloroethylene in a barber/beauty
shop which had a contaminated water supply.
Wisconsin. Wisconsin's ground-water standards were de-
veloped in response to widespread pesticide contamination
in ground water around the state. The state ground-water
law, enacted in 1983, directs the Department of Natural
Resources and Department of Health and Human Services
to set Enforcement Standards and Preventative Action Lim-
its for compounds found in ground-water supplies. Under
the ground-water law, all ground-water sources are treated
the same; there is no classification for anything less than
potable ground water. Atrazine and nitrates are the most
commonly found contaminants. In response to growing
contamination problems due to atrazine application and
family septic systems, the state is attempting to limit agri-
cultural application of atrazine in sensitive areas and estab-
lish strict codes for septic systems; regulators have
encountered resistance to both efforts.
Wisconsin provides anglers with information about fish
contamination, setting forth water and species-specific con-
sumption advisories in a booklet called "Health Guide for
People Who Eat Sport Fish from Wisconsin Waters." The
document discusses the health effects and risks posed by
eating PCB- and mercury-contaminated fish and provides
guidance on meal preparation that will reduce the health
risks.
Minnesota. Minnesota also has a fish consumption advi-
sory program in place. A representative from the Depart-
ment of Health's Health Risk Assessment Section described
the state's program and the risk assessment considerations
behind it Minnesota has had consumption advisories for
sport fish since 1970 and participates in the Great Lakes
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Fish Toxics Task Force. Along with the task force, the state
has moved away from depending on FDA advisories.
While fish advisories form the most important health pro-
gram because of the degree of exposure, Minnesota has
undertaken other initiatives to protect residents. For ex-
ample, the state issued a warning against using kerosene
heaters in unvented areas, is developing an advisory against
using an insect repellent, evaluated the health effects of
using bovine somatotrophin, and performed a literature
review to evaluate the risks posed by fluoride in drinking
water. The state does not think that the evidence for cancer
effects is very strong.
Region VH
The prevailing issues in Region VII concern agricultural
issues. Nitrate from fertilizer use has prompted formal state
enforcement actions for significant MCL violations. Atr-
azine, the most highly used herbicide in the region, has been
found in the Missouri River and in Kansas and Nebraska
surface waters. Farmers formerly used carbon tetrachloride
as a fumigant in grain bins; as a result, state surveys have
detected the compound in 96 Nebraska and Kansas public
water systems, and 43 are above the EPA MCL.
The region has undertaken several initiatives to help re-
gional states develop wellhead protection programs, train
farmers in best management practices for pesticide use,
conduct school lead monitoring programs, and initiate a
well-sampling program in Nebraska.
Missouri. A representative from the Missouri Department
of Health (DOH) described a joint study by DOH, the
University of Iowa, St. Louis University, and the Centers
for Disease Control (CDC) Laboratory to look at consump-
tion of chlordane-contaminated fish and serum-chlordane
levels in human serum. The investigators found a correla-
tion between fish consumption and serum level and con-
cluded that, as written and used, consumption advisories are
not a valid predictor of human exposure through fish con-
sumption.
Current Hot Issues
Secondary Health Effects Produced by Taste and Odor.
A representative from the Rhode Island Department of
Health presented a proposal for dealing with taste and odor
problems when household drinking water becomes con-
taminated with gasoline or fuel oil. Rhode Island considers
the nausea and headache produced by unpleasant taste and
odors real effects and takes action to mitigate the effects
and their source. To do this, the state has developed a
protocol for educating affected residents. State representa-
tives suggested that research to determine odor thresholds
for gasoline and fuel oil components would be useful for
identifying the offending components in the mixture.
Few states reported establishing a policy for odor thresh-
olds. Tom Hornshaw reported that the Illinois Leaking
Underground Storage Tank (LUST) unit enforces cleanup
by responsible parties so that there is no residual taste or
odor. Illinois published a pamphlet concerning gasoline
contamination in indoor air, ground water, surface water,
and drinking water which describes the health concerns and
ways to reduce exposure to gasoline and its components.
Advice for Private Well Owners. The group reviewed a
draft protocol for addressing private well owners' concerns
when contamination is found in their water supply. Few
states have policies regarding private wells. An issues paper
will survey state representatives to determine whether states
do or should pay for bottled water or filters, and whether
and how that influences state recommendations. The Con-
taminant Policy and Communications Subcommittee will
consider several issues while developing guidance for states,
for example:
• What is the assumed exposure duration?
• Does the state have authority to regulate and close
a private well?
• Will the results of tests become public record? In
Connecticut, water tests are part of the real estate
package when a house goes up for sale.
• How often do states encounter contaminants for
which there are no EPA standards?
NSF Certification Program. A senior lexicologist at NSF
International (NSF) (formerly the National Sanitation Foun-
dation) described the standards used by the American Na-
tional Safety Institute (ANSI) and NSF to evaluate drinking
water treatment chemicals (Standard 60) and drinking water
system components (Standard 61). The standards are devel-
oped with participation by utilities, manufacturer, regula-
tors, and consultants and are reviewed regularly to reflect
changing formulations and knowledge. Current projects
include evaluating solvent cements (especially those used
in plastic piping), polymers, elastomers, and organotin sta-
bilizers. NSF has published listings of certified water treat-
ment units and additives; both are available on-line. They
would like more input from states and others who use the
standards.
Impacts of the Radionuclide Rule. The American Water
Works Association (AWWA) formed two volunteer work-
groups to examine the issues raised by the proposed radon
rule. The first study to look at the cost of compliance
estimated that 32,750 systems exceed the proposed radon
standard, 26 percent more than estimated by EPA. The
primary difference between AWWA and EPA occurrence
estimates is in the updated inventory of nontransient,
noncommunity water systems relying on ground water used
by AWWA. AWWA also found costs higher than EPA's
estimates for unit treatment, disposal, and overall compli-
ance costs.
The second study examined the risks associated with radon
in drinking water, the uncertainties in the estimates, and the
cost-per-life-saved at various MCLs. The difference in na-
tional compliance costs between 1000 pCi/L and 200 pCi/L
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is about $2.5 billion (using AWWA's cost-of-compliance
study), which represents the cost to society incurred to
protect the smoking population.
Pesticides in Surface Waters of the Midwest. An AWWA
representative summarized the results from two surveys to
examine pesticide occurrence in the midwestern states. The
first was a U.S. Geological Survey (USGS) study of herbi-
cides in surface waters in South Dakota, Minnesota, Wis-
consin, Michigan, Iowa, Nebraska, Kansas, Missouri, Illinois,
Kentucky, and Ohio (Thurman, et al., Herbicides in Surface
Waters of the Midwestern United States: The Effect of
Spring Flush. Environ. Sci. Technol., 25:1794-96 [1991]);
the second study, conducted by the Missouri River Public
Water Supplies Association, measured herbicide concentra-
tions in the Missouri River and its tributaries during May,
June, and July 1991.
Training for Environmental Health Professionals. A
representative from the Tulane University School of Public
Health and Tropical Medicine's Department of Environ-
mental Health Sciences described a new program to de-
velop continuing education and degree programs for
environmental health professionals. Curriculum develop-
ment is being funded through a 3-year grant from the Health
Resources Services Administration; the University is cur-
rently gathering information about the tasks performed by
practicing professionals and determining the skills needed
to conduct those tasks.
Next Meeting. The next meeting of FSTRAC will take
place in Region VI (Dallas, Texas), April 1-3, 1992. For
more information on the meeting, contact Bob Cantilli or
Ed Ohanian, FTS 260-7571
For More Information. For more information about
FSTRAC or the teleconference series, contact Ed Ohanian
or Bob Cantilli (WH-568) at the Office of Water, Office of
Science and Technology, USEPA, 401 M St., S.W., Wash-
ington DC 20460.
Forum (continued from p. 1)
major scientific issues discussed at the meeting and the
recommendations made to EPA by the peer reviewers. The
workshop report includes EPA's pre-meeting statement of
issues, a summary by the workshop chair, remarks by
opening session speakers, reports by each of the four sub-
committees, and a list of participants at the meeting.
To obtain a single copy of each report, interested parties
should contact the ORD publications office, CERI-FRN, 26
West Martin Luther King Drive, Cincinnati, OH 45268,
Telephone FTS 684-7562 or (513) 569-7562. Please pro-
vide your name and mailing address and request the docu-
ment by the title and EPA number, "Alphas-globulin:
Association with Chemically Induced Renal Toxicity and
Neoplasia in the Male Rat" (EPA625-3-91/019F) and "Re-
port of the EPA Peer Review Workshop on Alpha^-globu-
lin: Association with Renal Toxicity and Neoplasia in the
Male Rat" (EPA/625/3-91/021), respectively. For further
information, please contact Jean Rodgers at FTS 260-6743
or (202) 260-6743.
IE. Around the Regions
Region II
Publications of Interest
The Office of Air Quality, Planning and Standards recently
released its 18th annual urban air quality trends titled "Na-
tional Air Quality and Emissions Trends Report." The
report highlights the annual urban air quality trends and
shows reductions for six major pollutants in the past nine
years. For additional information on the report, contact the
Office of Air Quality, Planning and Standards at FTS 629-
5558 or (919) 541-5558.
EPA's Environmental Assistance Division in the Office of
Toxic Substances publishes a bulletin titled "Chemicals In
Progress," highlighting activities within the Office of Toxics
Substances. The December 1991 issue included articles on
information available from Office of Toxic Substances
(OTS), the new chemicals program, the new Premanufacture
Notice Form, and a list of the TSCA Section 8(e) notices.
For additional information on this document, contact the
Environmental Assistance Division (TS-799), Office of
Toxic Substances, U.S. EPA, 401 M Street, S.W., Washing-
ton, D.C. 20460.
Contact: Marian Olsen, FTS 264-5682
Region IX
Risk Training Activities
During the months of December and January, Region IX
trained 76 people in the Risk and Decision Making course
and 92 people in the Risk Communication and Public
Involvement course. Andy Schwarz, who is working on the
Risk Communication rewrite, assisted as a facilitator. People
trained included staff and managers from Region IX, fed-
eral facilities, the state of California, and two guests from
the private sector. The training was very well received.
Both attendees from the private sector said, "We should
charge a lot of money for the course." Video tapes from
Risk Communication Training are being incorporated into a
briefing video to give people a better idea of the common
problems with risk communication and the value derived
from the course.
The document, "Public Meeting: Typical Questions and
Sample Responses," was revised in January 1992 as a result
of requests from the Office of Pesticides Programs and the
Illinois Department of Public Health. Both offices want to
incorporate the document into their risk communication
training program. Copies of the update may be obtained
from Alvin Chun, (415) 744-1019 or FTS 484-1019.
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Paula Bisson, a RCRA Section Chief, and Dianna Young,
Community Relations Section Chief, received On-the-Spot
Awards from the Deputy Regional Administrator for their
exceptional performance in providing Risk Communication
Training to die U.S. Department of Interior, Minerals Man-
agement Service. The training was greatly appreciated by
the Regional Director and his 40 staffers who attended,
since it provided insightful suggestions for dealing with
trust, credibility, and public perception issues.
Contact: Alvin Chun, FTS 484-1019 or (415) 744-1019
IV. Announcements
Bureau of Census—1992 Annual Research
Conference
The Bureau of the Census will host its 1992 Annual Re-
search Conference (ARC 1992) from March 22 to 25,1992,
at the Holiday Inn Crowne Plaza, 300 Army Navy Drive,
Arlington, Virginia 22202. The conference provides a fo-
rum for experts from around the world to discuss and
exchange current research and methods on areas relevant to
Census Bureau programs. The conference also features the
work of the American Statistical Association/National Sci-
ence Foundation/Census Research Fellows.
ARC 1992 addresses a wide variety of topics including:
accuracy of undercount estimates, modeling social changes
and ethnographic coverage evaluation, bias corrections for
survey data, quality management of statistical agencies,
post enumeration survey estimation issues, nonresponse
and estimation issues in establishment surveys, and elec-
tronic data collection. The conference sessions will feature
34 papers selected from 117 contributed abstracts from
researchers in government, private sector survey organiza-
tions, and academe who come from five countries.
For additional information on the meeting, contact Maxine
Anderson-Brown, Conference Coordinator, Office of the
Director, Bureau of the Census, Washington, D.C. 20233 or
(301)763-1150.
Society for Risk Analysis Course
The Society for Risk Analysis will hold its seventh annual
course, "New Directions in Risk Assessment," on April 13-
14, 1992, at the Hyatt Regency, Crystal City, Arlington,
Virginia. The intent of the course is to provide an introduc-
tory overview of methodologies, assumptions, and new
research in risk assessment. Lecturers will show how to
perform and interpret risk assessments and how to use them
in risk management. Special emphasis will be given to new
developments in pharmacokinetics and reproductive and
immunological risks. Lecturers will be Dr. Roy Albert,
Director, Institute of Environmental Health, Kettering Labo-
ratory, University of Cincinnati Medical Center; Dr. Eliza-
beth Anderson, President Clement International Corporation;
Dr. Mildred Christian, President and Director, Argus Re-
search Laboratories, Inc.; Dr. Vincent Covello, Center for
Risk Communication, Columbia University School of Pub-
lic Health; Dr. Bernard Goldstein, Director, Environmental
and Occupational Health Sciences Institute, Piscataway,
NJ; Dr. Loren Koller, Dean, College of Veterinary Medi-
cine, Oregon State University; Dr. Lester Lave, James H.
Higgins Professor of Economics, Graduate School of Indus-
trial Administration, Carnegie-Mellon University; Dr. Ri-
chard Reitz, Associate Scientist, Mammalian &
Environmental Toxicology, DOW Chemical Co.; Dr. Curtis
Travis, Director, Office of Risk Analysis, Oak Ridge Na-
tional Laboratory; and Dr. Chris Whipple, Vice President,
Clement International. For further information, please call
Dr. Curtis C. Travis, Course Director, at (615) 576-2107 or
Mary Oran, Course Coordinator, at (615) 376-9626.
American Public Health Association Meeting—
November 8-12,1992
The American Public Health Association is calling for
abstracts for its 120th Annual Meeting, to be held Novem-
ber 8-12, 1992, in Washington, D.C. The theme for the
meeting is "Uniting for Healthy Communities."
As part of the meeting, the Environment Section is solicit-
ing papers for sessions, posters, and roundtables addressing
all areas related to the environment. Particular attention will
be given to the theme and non-theme topics focusing on the
following issues: material use policy, environmental epide-
miology methods, environmental health leadership, public
education and environmental health, biotechnology, pesti-
cides, public health and environmental protection, imple-
mentation of toxic use reduction (TUR), environmental
equity, sustainable development and economic growth, clean
air amendments and emerging issues, cross-media ap-
proaches to pollution prevention, current issues in drinking
water quality, global production, and consumption patterns.
Abstracts should be submitted to: Circey Trevant, M.P.H.,
P. O. Box 111241, Nashville, Tennessee 37222-1241.
Risk and Decision-Making Courses Scheduled
The following is the schedule for the Risk and Decision-
Making Courses through June:
March 10-11
Region IX (Diamond Bar, CA.)
The following is the schedule for the Risk Communication
Workshops through June:
March 31-April 2 Region IX (Sacramento, CA.)
May 19-21 Region IX (Honolulu, Hawaii)
June 22-24 Region IX (Kaui, Hawaii
Contacts: Jim Cole, FTS 260-4538
Marian Olsen, FTS 264-5682
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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 Williams
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 VHI
Region IX
Region X
FTS 260-9640
FTS 260-5949
FTS 260-6743
FTS 260-2897
FTS 26^4126
FTS 776-8138
FTS 835-4885
FTS 264-5682
FTS 597-1177
FTS 257-1586
FTS 886-3388
FTS 255-6715
FTS 276-7415
FTS 330-1731
FTS 484-1018
FTS 399-2135
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 West Martin Luther King Drive
Cincinnati, Ohio 45268
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