Subject:  The RAPID REPORT, Executive Summary (fwd)
Date:     Tue, 15 Jun 1999 154210 -0500 (CDT)
From:     "Roy L. Beavers" <rbeavers@llion.org>
To:       emfguru <rbeavers@llion.org>
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                               Executive Summary
                                       
    Introduction
    
    Electrical energy has been used to great advantage for over 100 years.
    Associated with the generation, transmission, and use of electrical energy
    is the production of weak electric and magnetic fields (EMF). In the United
    States, electricity is usually delivered as alternating current that
    oscillates at 60 cycles per second (Hertz, Hz) putting fields generated by
    this electrical energy in the extremely low frequency (ELF) range.
    
    Prior to 1979 there was limited awareness of any potential adverse effects
    from the use of electricity aside from possible electrocution associated
    with direct contact or fire from faulty wiring. Interest in this area was
    catalyzed with the report of a possible association between childhood
    cancer mortality and proximity of homes to power distribution lines. Over
    the next dozen years, the U.S. Department of Energy (DOE) and others
    conducted numerous studies on the effects of ELF-EMF on biological systems
    that helped to clarify the risks and provide increased understanding.
    Despite much study in this area, considerable debate remained over what, if
    any, health effects could be attributed to ELF-EMF exposure.
    
    In 1992, the U.S. Congress authorized the Electric and Magnetic Fields
    Research and Public Information Dissemination Program (EMF-RAPID Program)
    in the Energy Policy Act (PL 102-486, Section 2118). The Congress
    instructed the National Institute of Environmental Health Sciences (NIEHS),
    National Institutes of Health and the DOE to direct and manage a program of
    research and analysis aimed at providing scientific evidence to clarify the
    potential for health risks from exposure to ELF-EMF. The EMF-RAPID Program
    had three basic components: 1) a research program focusing on health
    effects research, 2) information compilation and public outreach and 3) a
    health assessment for evaluation of any potential hazards arising from
    exposure to ELF-EMF. The NIEHS was directed to oversee the health effects
    research and evaluation and the DOE was given the responsibility for
    overall administration of funding and engineering research aimed at
    characterizing and mitigating these fields. The Director of the NIEHS was
    mandated upon completion of the Program to provide a report outlining the
    possible human health risks associated with exposure to ELF-EMF. This
    document responds to this requirement of the law.
    
    This five-year effort was signed into law in October 1992 and provisions of
    this Act were extended for one year in 1997. The Program ended December 31,
    1998. The EMF-RAPID Program was funded jointly by Federal and matching
    private funds and has been an extremely successful Federal/private
    partnership with substantial financial support from the utility industry.
    The NIEHS received $30.1 million from this program for research, public
    outreach, administration and the health assessment evaluation of ELF-EMF.
    In addition to EMF-RAPID Program funds from the DOE, the NIEHS contributed
    $14.5 million for support of extramural and intramural research including
    long-term toxicity studies conducted by the National Toxicology Program.
    NIEHS Conclusion
    
    The scientific evidence suggesting that ELF-EMF exposures pose any health
    risk is weak. The strongest evidence for health effects comes from
    associations observed in human populations with two forms of cancer:
    childhood leukemia and chronic lymphocytic leukemia in occupationally
    exposed adults. While the support from individual studies is weak, the
    epidemiological studies demonstrate, for some methods of measuring
    exposure, a fairly consistent pattern of a small, increased risk with
    increasing exposure that is somewhat weaker for chronic lymphocytic
    leukemia than for childhood leukemia. In contrast, the mechanistic studies
    and the animal toxicology literature fail to demonstrate any consistent
    pattern across studies although sporadic findings of biological effects
    (including increased cancers in animals) have been reported. No indication
    of increased leukemias in experimental animals has been observed.
    
    The lack of connection between the human data and the experimental data
    (animal and mechanistic) severely complicates the interpretation of these
    results. The human data are in the "right" species, are tied to "real-life"
    exposures and show some consistency that is difficult to ignore. This
    assessment is tempered by the observation that given the weak magnitude of
    these increased risks, some other factor or common source of error could
    explain these findings. However, no consistent explanation other than
    exposure to ELF-EMF has been identified.
    
    Epidemiological studies have serious limitations in their ability to
    demonstrate a cause and effect relationship whereas laboratory studies, by
    design, can clearly show that cause and effect are possible. Virtually all
    of the laboratory evidence in animals and humans and most of the
    mechanistic work done in cells fail to support a causal relationship
    between exposure to ELF-EMF at environmental levels and changes in
    biological function or disease status. The lack of consistent, positive
    findings in animal or mechanistic studies weakens the belief that this
    association is actually due to ELF-EMF, but it cannot completely discount
    the epidemiological findings.
    
    The NIEHS concludes that ELF-EMF exposure cannot be recognized as entirely
    safe because of weak scientific evidence that exposure may pose a leukemia
    hazard. In our opinion, this finding is insufficient to warrant aggressive
    regulatory concern. However, because virtually everyone in the United
    States uses electricity and therefore is routinely exposed to ELF-EMF,
    passive regulatory action is warranted such as a continued emphasis on
    educating both the public and the regulated community on means aimed at
    reducing exposures. The NIEHS does not believe that other cancers or
    non-cancer health outcomes provide sufficient evidence of a risk to
    currently warrant concern.
    
    The interaction of humans with ELF-EMF is complicated and will undoubtedly
    continue to be an area of public concern. The EMF-RAPID Program
    successfully contributed to the scientific knowledge on ELF-EMF through its
    support of high quality, hypothesis-based research. While some questions
    were answered, others remain. Building upon the knowledge base developed
    under the EMF-RAPID Program, meritorious research on ELF-EMF through
    carefully designed, hypothesis-driven studies should continue for areas
    warranting fundamental study including leukemia. Recent research in two
    areas, neurodegenerative diseases and cardiac diseases associated with
    heart rate variability, have identified some interesting and novel findings
    for which further study is ongoing.
    Background
    
      Program Oversight and Management
      
      The 1992 Energy Policy Act created two committees to provide guidance and
      direction to this program. The first, the Interagency Committee (IAC),
      was established by the President of the United States and composed of
      representatives from the NIEHS, the DOE and seven other Federal agencies
      with responsibilities related to ELF-EMF. This group receives the report
      from the NIEHS Director and must prepare its own report for Congress. The
      IAC had responsibility for developing a strategic research agenda for the
      EMF-RAPID Program, facilitating interagency coordination of Federal
      research activities and communication to the public and monitoring and
      evaluating the Program.
      
      The second committee, the National EMF Advisory Committee (NEMFAC),
      consisted of representatives from public interest groups, organized
      labor, state governments and industry. This group was involved in all
      aspects of the EMF-RAPID Program providing advice and critical review to
      the DOE and the NIEHS on the design and implementation of the EMF-RAPID
      Program's activities.
      
      
      ELF-EMF Health Effects Research
      
      The EMF-RAPID Program's health effects research initiative relied upon
      accepted principles of hazard identification and risk assessment to
      establish priorities. All studies supported by the NIEHS and the DOE
      under this program were selected for their potential to provide solid,
      scientific data on whether ELF-EMF exposure represents a human health
      hazard, and if so, whether risks are increased under exposure conditions
      in the general population. Research efforts did not focus on
      epidemiological studies (i.e. those in the human population) because of
      time constraints and the number of ongoing, well-conducted studies. The
      NIEHS health effects research program focused on mechanistic, cellular
      and laboratory studies in the areas of neurophysiology, behavior,
      reproduction, development, cellular research, genetic research, cancer
      and melatonin. Mechanistic, cellular and laboratory studies are part of
      the overall criteria used to determine causality in interpreting
      epidemiological studies. In this situation, the most cost-effective and
      efficient use of the EMF-RAPID Program's research funds was clearly for
      trying to clarify existing associations identified from population
      studies. The DOE research initiatives focused on assessment of exposure
      and techniques of mitigation.
      
      The EMF-RAPID Program through the combined efforts of the NIEHS and the
      DOE radically changed and markedly improved the quality of ELF-EMF
      research. This was accomplished by providing biological and engineering
      expertise to investigators and emphasizing hypothesis-driven,
      peer-reviewed research. Four regional facilities were also set-up where
      state-of-the-art magnetic field exposure systems were available for
      in-house and outside investigators to conduct mechanistic research. The
      EMF-RAPID Program through rigorous review and use of multi-disciplinary
      research teams greatly enhanced the understanding of the interaction of
      biological systems with ELF-EMF.
      Information Dissemination and Public Outreach
      
      The EMF-RAPID Program provided the public, regulated industry and
      scientists with useful, targeted information that addressed the issue of
      uncertainty regarding ELF-EMF health effects. Two booklets, a question
      and answer booklet on ELF-EMF and a layman's booklet addressing ELF-EMF
      in the workplace, were published. A telephone information line for
      ELF-EMF was available where callers could request copies of ELF-EMF
      documents and receive answers to standard questions from operators. The
      NIEHS also developed a web-site for the EMF-RAPID Program where all of
      the Program's documents are on-line and links are available to other
      useful sites on ELF-EMF. Efforts were made to include the public in
      EMF-RAPID Program activities through sponsorship of scholarships to
      meetings; holding open, scientific workshops; and setting aside a
      two-month period for public comment and review on ELF-EMF and the
      workshop reports. In addition, the NIEHS sponsored attendance of NEMFAC
      members at relevant scientific meetings and at each of the public comment
      meetings.
      Health Risk Assessment of ELF-EMF Exposure
      
      In preparation of the NIEHS Director's Report, the NIEHS developed a
      process to evaluate the potential health hazards of ELF-EMF exposure that
      was designed to be open, transparent, objective, scholarly and timely
      under the mandate of the 1992 Energy Policy Act. The NIEHS used a
      three-tiered strategy for collection and evaluation of the scientific
      information on ELF-EMF that included: 1) three science review symposia
      for targeted ELF-EMF research areas, 2) a working group meeting and 3) a
      period of public review and comment. Each of the three symposia focused
      on a different, broad area of ELF-EMF research: mechanistic and cellular
      research (24-27 March 1997, Durham, NC), human population studies (12-14
      January 1998, San Antonio, TX) and laboratory human and clinical work
      (6-9 April 1998, Phoenix, AZ). These meetings were aimed at including a
      broad spectrum of the researchcommunity and the public in the evaluation
      of ELF-EMF health hazards, identifying key research findings and
      providing opinion on the quality of this research. Discussion reports
      from small discussion groups held for specific topics were prepared for
      each meeting.
      
      Following the symposia, a working group meeting (16-24 June 1998,
      Brooklyn Park, MN) was held where a scientific panel reviewed historical
      and novel evidence on ELF-EMF and determined the strength of the evidence
      for human health and biological effects. Stakeholders and the public
      attended this meeting and were given the opportunity to comment during
      the process. The Working Group conducted a formal, comprehensive review
      of the literature for research areas identified from the symposia as
      being important to the assessment of ELF-EMF-related biological or health
      effects. Separate draft documents covering areas of animal
      carcinogenicity, animal non-cancer findings, physiological effects,
      cellular effects, theories and human population studies (epidemiology
      studies) in children and adults for both occupational and residential
      ELF-EMF exposures were rewritten into a single book. The Working Group
      characterized the strength of the evidence for a causative link between
      ELF-EMF exposure and disease in each category of research using the
      criteria developed by the International Agency for Research on Cancer
      (IARC).
      
      The IARC criteria fall into four basic categories: sufficient, limited,
      inadequate and evidence suggesting the lack of an effect. After critical
      review and discussion, members of the Working Group were asked to
      determine the categorization for each research area; the range of
      responses reflected the scientific uncertainty in each area. A majority
      of the Working Group members concluded that childhood leukemia and adult
      chronic lymphocytic leukemia from occupational exposure were areas of
      concern. For other cancers and for non-cancer health endpoints, the
      Working Group categorized the experimental data as providing much weaker
      evidence or no support for effects from exposure to ELF-EMF.
      
      Following the Working Group Meeting, the NIEHS established a formal
      review period for solicitation of comments on the symposia and Working
      Group reports. The NIEHS hosted four public meetings (14-15 September
      1998, Tucson, AZ; 28 September, Washington, DC; 1 October 1998, San
      Francisco, CA; and 5 October 1998, Chicago, IL) where individuals and
      groups could voice their opinions; the meetings were recorded and
      transcripts prepared. In addition, the NIEHS received 178 written
      comments that were also reviewed in preparation of this report. The
      remarks that NIEHS received covered many areas related to ELF-EMF and
      provided insight about areas of concern on behalf of the public,
      researchers, regulatory agencies and industry.
      




Archive provided courtesy of WaveGuide, http://www.wave-guide.org
Reprinted with permission of Roy Beavers, http://www.feb.se/EMF-L/EMF-L.html