EPA/SAB/8G/Q01
Redirection of the Energy-Related
Health Effects Research Programs
Health Effects of Criteria and Non-Criteria Pollutants
from Fossil-Fuel Combustion (Theme 1}
A Report of the Subcommittee on
Energy-Related Health Effects Research
September 1980
Science Advisory Board
U.S. Environmental Protection Agency
Washington, D.C. 20460
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EPA NOTICE
This report has been written as part of 'the activities of
the Science Advisory Board, a public advisory group providing
extramural scientific information to the Administrator and other
officials of the Environmental Protection Agency. "Hie Board is
structured to provide a balanced expert assessment of the
scientific matters related to problems facing the Agency. This
report has not been reviewed for approval by the Agency, hence
its contents do not necessarily represent the views and policies
of the Environmental Protection Agency, nor does mention of trade
names or commercial products constitute endorsement or
recommendation for use.
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SCIENCE ADVISORY BOARD
SUBCOMMITTEE ON ENERGY-RELATED HEALTH EFFECTS RESEARCH
(Section A - Health Effects of Air Pollutants)
Chairman;
Dr. James I*. Whittenberger, Professor of Physiology, James
Stevens Simmons Professor of Public Health, School of Public
Health, Harvard University, 665 Huntington Avemie, Boston,
Massachusetts 02115
Members;
Dr. Jack 0. Hackney, Chief, Environmental Health Laboratories,
Professor of Medicine, Rancho Los Amigos Hospital Campus of the
University of Southern California, 7601 East Imperial Highway,
Downey, California 90242
Dr. Ian T» Higgins, Department of Epidemiology/ School of Public
Health, The University of Michigan, 109 Observatory, Ann
Arbor, Michigan 48104
Dr. Daniel Menzel, Associate Professor of Pharmacology and
Experimental Medicine and Director, Laboratory of
Environmental Pharmacology and Toxicology, Duke University
Medical Center, Durham, North Carolina 27710
SAB Staff Officer;
Mr. Ernst Linde, Scientist Administrator, Science Advisory Board
A-101, U.S. Environmental Protection Agency, Washington,
D.C. 20460 Phone: (202) 472-§444
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BACKGROUND
In September 1979 the Energy Effects Division of the Office
of Research and Development (QRD} requested Science Advisory Board
(SAB) assistance in a program planning effort to redirect
portions of the Interagency Energy/Environment Program for
fiscal years 1980 - 1984, One of these portions is the theme
"The Health Effects of Criteria and Non-Criteria pollutants from
Fossil Fuel Combustion." The redirection of this group of
projects was initiated by QHD's Energy Effects Division and is
consistent with a request from the Office of Air Quality
Planning and standards (OAQPS) for more information on human
health effects in geographic areas where criteria pollutant
standards are routinely being exceeded.
Specifically, OAQPS and the Energy Effects Division
requested advice about the proper balance among epidemiclogic,
clinical, and animal toxicologic studies? how such studies should
relate to each other; how the program should be integrated? and
how the projects which are ongoing should be modified.
In planning the second five-year period of the Interagency
Program, the Energy Effects Division assigned approximately $3.1
million for animal toxicology projects, most of them inherited
from the Department of Energy National Laboratory transfer!
$630,000 was assigned to clinical studies, most of which were
carried over from the first five-year period?1 and $2.8 million
was assigned to new epidemiology studies. This effort is
approximately 40% of the total interagency energy-health
research program.
PROCEDURE
To provide informed advice on redirecting portions of the
energy-related health effects research, the Subcommittee had to
have the fullest understanding possible of the needs of OAQPS,
as well as the content of both the current interagency-funded
health effects research and the current "base program,1* that is,
the health effects research on criteria and non-criteria
pollutants funded(through legislative mandates other than the
Interagency Program (nevertheless related to energy), It was
also considered advantageous to have fiPA-recommended changes in
the Program as a basis for SAB discussion.
Substantial progress was made toward these objectives in
meetings held in Washington, B.C. on November 13 and 14 and December
18 and 19, 1979, and at a. workshop in Raleigh, North Carolina on
January 28-30, 1980. The workshop provided a much needed
vehicle for communication among all interested parties—
scientists from the Department of Energy (DOE), National Labora-
tories and EPA laboratories, representatives from air program
offices, ORD headquarters, the SAB, and others. It was
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especially valuable as a forum In which National Laboratory
scientists and administrators could learn about and interact
with EPA staff regarding the research needs of EPA as a
regulatory agency,
After the workshop and follow-up communication between EPA
and research project directors, there was a final meeting of
the Subcommittee on April 11, 1980 to review the revised
protocols and the recommendations of iPA staff*
FINDINGS and COMMENTS
The Subcommittee was very favorably impressed by the
efforts of Mr. Frietsch and his staff and by the scientists at
the Health Effects Research Laboratory in Research Triangle
Park, North Carolina (HESL-HTP) who reviewed the projects,
made recommendations of changes to improve relevance, and
helped develop the communication with scientists outside EPA,
which is essential to future success of the endeavor. The
HERL-RTP scientists included Brs, Graham, Hayes, lazuka, Miller
and Riggan, with Drs. Miller and Graham playing leadership
roles.
The Subcommittee agrees with most of the recommendations of
the HERL-RTP group. These EPA staff reports and related papers,
as presented at the December 1979 and April 1980 meetings of the
Subcommittee, are a matter of record and will not be extensively
quoted at this time. A few highlights will suggest the flavor
of the EPA staff reports.
In general, most of the unmodified projects were considered
to have only limited relevance to EPA. Even when modified, some
of the projects will have only moderate relevance. To improve
relevance, interaction between research planners and principal
investigators will be needed over the next few years, and
continuing dialogue thereafter. Such Interaction would be
promoted by research planning workshops and the involvement of
laboratory representatives in research planning activities.
The HERL-RTP scientists also noted the serious management
problem inherent in improving coordination between EPA and
scientists outside of EPA. In some cases EPA will have project
officers who are thoroughly knowledgeable of regulatory needs
and the content of the "base program* and who can interact
effectively with project scientists. However, the number of
HERL-RTP scientists actually available to serve as project
officers could not possibly meet the need, given the number of
projects involved.
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Another suggestion of HERL-RTP scientists, with which the
Subcommittee strongly concurs, is that research protocols be
submitted for all studies. These would provide the basis for
review of scientific merit, as well as relevance to EPA needs,
and would include details of study design, statistical analysis,
and quality control, particularly for exposure regimens and
methodology,
Subcommittee members usually perceived their role as a dual
one. They were asked to offer scientific judgments on
individual projects and to assess the research in terms of
relevance, cohesion, and balance. Scientific judgments had to be
made in the context of project descriptions that were often
vague and imcomplete. Of necessity, judgments were made on
general approaches rather than on detail. Further, limited
information was available on the current status of research
progress. Thus, the usual role of reviewing and commenting on
scientific merit was severely restricted,
The role of assessing the research program in terms of
relevance to the missions of SPA was made especially difficult
because principal investigators often had erroneous impressions of
the requirements of the Agency. Insufficient guidance had been
provided for preparing the project abstracts. Many
investigators focused on final applications of their work rather
than on a realistic presentation of current status of results
achieved to date. Also, little attention was given to
alternative plans In case original goals could not be realized.
SUMMARY and CONCLUSIONS
Animal Toxicology
The revised protocols are, almost without exception, much
improved and more relevant to EPA needs than were the original
submissions. This Improvement is no doubt due to the clear
communication of EPA needs by Drs. Graham and Miller and the
forceful administration of Mr, Frietsch. This improvement
Illustrates that a more relevant program is possible and that
the present program can be Improved further. Eventually, EPA
will have to provide more staff and more detailed direction to
achieve an acceptable level of performance in terms of EPA's
needs.
Since most of the projects request support for four years
or longer, approval of these protocols represents a long-term
commitment of research support. One must question the basic
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tenet under which the compromise protocols have been drawn up.
EPA staff in its general comments states, as given, "the
objective of increasing relevance without major dislocations
within the involved National Laboratories...." If it is
presumed that National Laboratories are invariably the best
place to carry out this work, the Subcommittee would seriously
question such presumption.
The total budget committed to this segment of
energy-environment research is not inconsequential. Every
proposal's budget requests more funds than originally allocated
because the work is being reoriented. This may, among other
things, indicate a deficient level of scientific expertise, in the
laboratories, in toxicology and especially in air pollution toxicology.
A very thorough review will be necessary to upgrade the
scientific content of the projects. There is a point, however,
where reviewers cannot help except by writing protocols. Then
one must ask, is this group capable of carrying out the
experiments even given acceptable protocols? The present
federal support of research is, by necessity, a highly
competitive endeavor, and those who cannot compete will not be
supported. Should not the same standard of quality be applied
here as elsewhere?
The Subcommittee favors application of the highest
standards of quality, the most detailed review possible, and
giving priority to the most relevant proposals, Undoubtedly
such reviews, to be impartial, require a great deal of effort by
reviewers, grantees, and administrators. If the program is to
be reoriented to SPA's needs and kept on track to meet these
needs, then EPA review is and will be essential.
There is still a lack of cohesiveness in the overall
goals of these proposals. Eventually a further redirection,
review, and winnowing will be needed to accomplish an
integrated and well conceived program.
Clinical Studies
The Subcommittee, in general, endorses the quality and
direction of the program in controlled human exposure to air
pollutants. Because information obtained from such studies can
be immediately relevant to setting air quality standards, even
further expansion of effort in this area should be encouraged.
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Close coordination among human exposure studies, already under-
way, should be strongly encouraged. This should Include exchange of
protocols, regular meetings of cooperating scientists, and
workshops on such topics as development of methods of
quantitative aerosol exposure and methods for pharmacologic
evaluation of airway reactivity. In this field of applied
research, scientific breakthroughs by individual laboratories
are not the main goal, so proprietary considerations are
secondary. Exposure atmospheres to be studied will be extremely
sensitive to trace background contamination. Therefore, a
careful investigation should be conducted to determine that the
best possible air purification and exposure monitoring
techniques are available.
Epidemiolocfic Studies
The Subcommittee supports the aim to increase the number of
eptdemiologic studies of air pollution, provided that projects
of high scientific merit and relevance can be identified. Well
conducted epidemiologic studies can provide the evidence needed
to decide on appropriate standards which may be unobtainable in
any other way. Unfortunately, such studies become increasingly
difficult the lower the pollutant concentration and the more
subtle the deterioration in health and functional capacity.
Consequently, meticulous attention to details, both of
monitoring exposures and measuring health indices, is crucial to
success.
We support the actions taken on specific new proposals
considered in this planning exercise.
General Observations
Overall, we believe an excellent start has been made in
improving the balance among animal toxicology, clinical, and
epidemiologic studies; in improving relevance In individual
projects? and in developing effective communication with
scientists in the National Laboratories. However, there is
still a long way to go. Several requirements must be met
before the projects reviewed in this planning effort will meet
EP&'s needs in terms of scientific merit and relevance.
First, all projects must be subjected to rigorous peer
review of the sort practiced by NIH study sections and
apparently being practiced by the review panels of ORO's new
central grants administration* The latter mechanism would be a
desirable one to use for these energy-^environment projects.^/
Peer review requires a much more detailed project
description than we have seen for any of the proposals we
reviewed. The NIH grant proposal model may not be ideal, but we
The Subcommittee has been advised and is pleased to note
that steps are already underway to implement this recommendation,
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suggest that EPA consider it seriously before adopting a less
demanding proposal form. A detailed progress reporting system
Is also essential—something that we have not seen in this
review but which Is an inherent part of NIH grant review.
We would not accept an in-house peer review system either
by EPA or by a National Laboratory as an adequate substitute for
external peer review for scientific merit.
Finally, EPA must find resources to strengthen its
management of this program. The Subcommittee has already
commented that Mr. Prietsch and his staff have done an excellent
job, but this is a multimlllion dollar program and needs more
than two or three people to manage it effectively in the complex
environment in which it has to operate, As also mentioned
before, HURL^RTI* scientists have done an excellent job in
this planning effort, Biey would make superb project
officers, but they have other full-time activities without
adding this special assignment. Uie Subcommittee is not in a
position to make specific suggestions about personnel
assignments and management, but we are concerned that the
promising start made in this planning activity will be lost if
more people cannot be Involved in the management of this
program.
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