• The experimental animal must be an appropriate surrogate for human response to the tested agent.

  • The ability to detect small toxic effects can be severely limited by the number of animals that can be assayed.

  • Chronic toxic effects must be interpreted in animal studies through a knowledge of the dose-response relationships for the toxic effects of concern.

Review of Research Strategy Adopted by EMF-RAPID Program

The interim report noted that the research strategy of the EMF-RAPID program attempts to balance breadth and depth within a limited budget and schedule. The committee found no glaring omissions in the program but recommended that it "include mechanisms for seeking rapid confirmation of important observations and for the rapid implementation of studies that seek to test new hypotheses that appear especially relevant".

Strengths and limitations of the program were noted. Of the three specific goals stated in the Research Agenda and Communication Plan, EMF-RAPID Program (DOE 1994a), the committee expressed doubts that the first goal, determination of the health effects of MF exposure, could be definitively reached within the limitations of the 5-yr program. It noted that the second goal, development of techniques to mitigate any adverse health risks, seemed premature. The third goal, dissemination of scientifically valid information to the public, was considered appropriate and a clear strength of the program. Program weaknesses cited by the committee included the absence of a clearly defined methodology to be used in risk determination. Another shortcoming noted by the committee was the decision to conduct all biology and health-related research through the NIH grant process. The committee strongly recommended that a special study section be formed within the EMF-RAPID program to evaluate new proposals and competing renewals of program projects, particularly with a view to bringing the program to closure in some reasonable period. It was also recommended that the program office consider selected use of cooperative agreements to allow more-focused studies to be performed when needed.

The interim report commented on the EMF-RAPID program strategy and tactics, citing the emphasis on replication studies and the fact that the broad approach for cultured-cell systems was combined with a more specific focus on copromotion-cocarcinogenesis and melatonin effects in the animal studies. The committee felt that the strategy represented a solid compromise based on intriguing data and reasonable hypotheses but that it was unlikely over the program's lifetime to produce a database sufficient to support a formal risk analysis.

Description of Work Initiated Under EMF-RAPID Program

The interim report noted 16 current and 10 expected engineering projects, 10 communication projects, 14 in vitro biology projects, and seven in vivo biology projects. Some proposed engineering and communications projects were eventually canceled because of budget cuts. The number of EMF-RAPID-funded NIEHS in vivo and in vitro projects, however, increased to a total of 61 projects.



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