UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C. 20460
                                                                OFFICE OF
                                                             THE ADMINISTRATOR
May 11,1992

EPA-SAB-RAC-LTB-92-009

Honorable William K. Reffly
Administrator
U.S. Environmental Protection Agency                          *
401 M Street SW
Washington, DC 10460

Subject:     Review of A Resmrch Strategy for Electric and Magmtic Fields:
            Research Needs and Priorities  (EPA/6G0/9-91/016A)

Dear Mr. Reilly:

      In response to an October 12, 1990, memorandum by EPA's Office of Health
and Environmental Assessment, Office of Health Research, and Office of Radiation
Programs, the Radiation Advisory Committee's Nomonizing Electric and Magnetic
Fields Subcommittee reviewed  the above referenced document at a public meeting
on July 24-26,1991,  This report represents  the consensus of the Subcommittee,
with the exception of one Member, who expressed fundamental disagreement with
EPA's approach to developing a research strategy.

Response to The Charge of October 12,1990

      1,     Does the document identify the major research topics for electric and
            magnetic fields? Specifically, are any identified topics inappropriate
            and are all topics identified?

      The June 1991 Research Strategy contains chapters on health effects,
biophysical mechanisms, exposure assessment, and control technology.  Although the
topics identified in the document are relevant to EPA's mission, the Subcommittee
notes that a national research agenda should also consider occupational, diagnostic,
and therapeutic uses of extremely low frequency fields.   The document itself does
not specify the breadth of the audience for this research strategy.
                                                         Printed on fteeycted Paper

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      2.    Is the level of detail sufficient to set priorities among the research!
            topics?

      The document, which is well written and informative, describes both the
relevant issues and EPA's responsibilities.  However, the level of detail in the
document is insufficient for setting specific research goals and priorities.  Setting a
research agenda, for either the nation or the Agency, would require considerably
more detail and an explicit philosophy for setting priorities.  If EPA chooses to
develop a  scientifically credible research strategy independently, it should also
propose a mechanism by which such a strategy can be implemented, preferably
through the collective efforts of an appropriate interdisciplinary advisory committee
of experts familiar with both electric and magnetic field health research and with
current Federal activities in the area.

      The Subcommittee anticipates that such an advisory committee would call for
a strategy of systematically laying- out and testing alternative hypotheses about the
nature of the biophysical and biological mechanisms and causal pathways involved.
The Subcommittee also expects that such an advisory committee would rank
priorities for each broad group and allow sufficient latitude in scoring so that
specific areas of important research within a broad group, such as control technolo-
gy, might  be given a higher rank than the group as a whole.  The advisory commit-
tee's activity should not be limited to the scientific aspects of the problem, but the
committee should also be directed toward identifying appropriate sources of funding
and related oversight activities.

      3.    Do any research topics stand oiit  as higher priority issues for assessing
            human health risk?

      The EPA document properly focuses on  cancer and on exposure-definition
issues as priority areas for human health research; however, effects on nervous
system and sensory structures should  receive more emphasis than indicated in the
EPA document because there is evidence of interaction of electric and magnetic
fields with neural tissue from cellular  and animal studies, A research strategy must
emphasize the more fundamental and  far-reaching need for basic understanding of
biological effects and biophysical mechanisms because, without such basic knowl-
edge, research regarding cancer risks and exposure parameters is likely to be
ignored.

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Comments and Recommendations

      Research is Needed.  The Subcommittee therefore recommends that scientific
information sufficient to support credible formal risk assessment of exposure to
electric and magnetic fields be developed.  Current scientific information suggesting
links between electric and magnetic fields and human health effects is far less
persuasive than that for chemical exposures related to workplace settings, ambient
air pollutants, indoor air pollution, or pollutants in drinking water. The recommen-
dation for research is justified by the almost universal exposure of populations to
electric and magnetic fields throughout life, the limited options for individual
e;xposure reduction, and the years needed to implement widespread measures for
reducing population exposure, Furthermore, the health effect endpoints suggested
by epidemiology studies include childhood leukemia which results in many .years of
useful M© lost per case. In the absence of data to support a credible quantitative
risk assessment, public concern could result in sizable expenditures that may be
unwarranted.  The Science Advisory Board's report Reducing Risk (BPA-SAB-EC-
90-021) explicitly  recognizes the need for data collection in this area when it states
(p.18)

      EPA's health-related data  collection efforts should not be Umited to
      those areas where risks to  human health already are recognised. EPA
      also needs to develop an ability to predict the potential future risks of
      emerging problems (e.g>, low-level exposures to electromagnetic fields).
      Therefore EPA should establish ».. long-range research on emerging
      problems,

      Priorities Should Be Detennmed, In terms of priorities for research, the
Subcommittee notes first of all that there is widespread skepticism in the scientific
community about the existence of mechanisms that might produce biological effects
from weak, extremely low frequency fields such as the 60-Hz fields. Because
biological plausibility is an important factor in considering the strength of epidemio-
logical evidence, the lack of a widely accepted demonstrated mechanism currently
limits the extent to which cancer causation may be inferred from the epidemiology
studies.  Much of the disagreement about mechanisms is based on the thin and
sometimes inconsistent experimental base. The Subcdmmittee therefore recom-
mends that high priority be placed  on identifying and replicating in several labora-
tories the few key experiments that can determine the reproducibility of effects that
appear to challenge simple biophysical models. The Subcommittee believes that
specific biophysical and biological mechanisms can now be postulated and systemati-
cally explored.

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      A second limitation on the extent to which cancer causation may be inferred
from the epidemiology studies is the current inability to quantify exposure in a
useful way.  Although many epidemiological studies have relied, on time-averaged
field strength, other specific attributes of the field (e.g., time rate of change, spectral
content, and polarization) as well as the characteristics of the biological responses
(e.g., thresholds, resonances, and multistage processes with differing rate constants)
may be more important.  The identification of the relevant metric is critical both to
formal risk assessment and to risk management should a significant risk be found to
exist. Therefore, the Subcommittee places a high priority on research that eluci-
dates the precise nature of the association between environmental low-frequency
electric and  magnetic fields and human health effects.

      Three applied research areas are not included in the EPA document in which
the Subcommittee recommends some limited effort be undertaken: risk perception,
risk communications, and risk management.  This recommendation is made in
recognition of the concerns the public expressed in the extensive (and often emo-
tional) public testimony and is  not based on the Subcommittee's own perception of
the priorities of the scientific community.   The Subcommittee recommends that
EPA establish appropriate ways of responding to public questions and concerns.

      Finally, the Subcommittee believes that resolution of the major research
questions in this field is highly unlikely in a three- to five-year time frame as
suggested by the EPA document and that the resources needed for such resolution
may exceed by perhaps an order of magnitude the roughly $10 million currently
expended annually.

      The Purpose for the Strategy. Although the EPA document is written in
clear language and organized in a way that makes it easy to understand,  its motiva-
tion and objectives are not adequately explained and need to be clarified. Whereas
priorities for broad research categories are identified, the EPA document does not
establish specific research priorities or provide estimates of resources and time
needed to undertake the research. Without these features, the EPA document does
not serve the scientific community as a research strategy document and is of
doubtful value for government planning and budgeting.

      The Subcommittee regards the process of setting research priorities and
developing the interagency interactions necessary for the conduct of the research as
very important.  To ensure that the maximum benefit will be derived from  the
electric and  magnetic field research now being conducted and contemplated, EPA
should both develop a means of identifying research  needs and priorities  within a

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broad interagency scopet and provide for communication of research plans and
results among the various agencies.   Such a scoping effort would provide a strategy
or context in which each entity can develop its research agenda, recognizing where
gaps may exist or interests overlap.  This process would provide a basis for effective
mterageney cooperation and communication. Such an interageney committee should
conduct meetinp open to the public and interested scientists and meet at regular
intervals to discuss the progress of the research, its funding and management, and
related questions.

      The  Science Advisoiy Board is pleased to have had the opportunity to review
the draft document and to offer "its advice.   We would appreciate  BPA's written
response to the major issues we have raised, particularly with regard to the
eventual development of an implementable research strategy for EPA. •-
                                               (?
                              Dr. Esmond C, Loehr,
                              Science Advisjgjy
                              Dr. Oddvar F. Nygaard^hair
                              Radiation Advisory Committee
                              Dr. Genevieve M. MatanosM, Chair
                              Nonionizing Electric and Magnetic
                              Fields Subcommittee
                              Dr. £)avid V. Bates, Vice-Chair
                              Nonionizing Electric and Magnetic
                              Fields Subcommittee
Enclosure:  Subcommittee roster

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              U. S. ENVIRONMENTAL PROTECTION AGENCY
                       SCIENCE ADVISORY BOARD
                   RADIATION ADVISORY COMMITTEE
    NONIONIZING ELECTRIC AND MAGNETIC FIELDS SUBCOMMITTEE

                                ROSTER
CHAIR
Dr. Genevieve Matanoski, The Johns Hopkins University, School of Hygiene and Public
   Health

VICE CHAIR
Dr, David Bates, Vancouver, Canada

MEMBERS
Dr. A. Karim Ahmed, Community for NIE

Dr.   Patricia A. Buffler, University of Texas Health Center, School of Public Health

Dr. Craig V. Byus, University of California

Dr. Kelly H. Clifton, University of Wisconsin Clinical Cancer Center

Dr, John DiGiovanni, University of Texas, M.D, Anderson Cancer Center

Mr, William E. Feero, Electric Research and Management, State College, PA 16804

Dr. Robert Harris, School of Public Health, University of North Carolina

Dr, Clark Heath, American Cancer Society

Dr, Nan Laird, Harvard School of Public Health

Dr. M. Granger Morgan, Carnegie-Mellon University

Dr. Donald Pierce, Oregon State University

Dr, Mary Ellen O'Connor, University of Tulsa

Dr. Charles Susskind, University of California

Dr. Bary Wilson, Battelle Pacific Northwest Laboratory

Dr, Richard Wilson, Harvard University

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DESIGNATED FEDERAL OFFICIAL
Mrs. Kathleen W. Conway
      Science Advisory Board
      U.S. Environmental Protection Agency
      401 M Street, S.W., A-101F
      Washington, B.C.  20460

STAFF SECRETARY
Mrs. Dorothy M. Clark
      Secretary, Science Advisory Board
      U,S. Environmental Protection Agency
      401 M Street, S.W., A-101F
      Washington, B.C.  20460
         Director
Mr. Robert Flask
      Environmental Protection Agency
      401 M Street S.W., (A101)
      Washington, D.C.  20460

DIRECTQE
Dr. Donald G. Barnes
      Environmental Protection Agency
      401 M Street S.W., (A101)
      Washington, D,C,  20460

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