UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
        12  1986            WASHINGTON. O C  20460

honorable Lee M. Thomas                             SAB-EC-S6-027
Administrator
U. S, Environmental Protection Agency
401 M Street, S, W.                                                 *o*Jl" ?»
Washington, D.  C,  20460                                         '**E 4D**"'"STB*'

Dear Mr, Thomas:

     At its July 10-11 meeting the Science Advisory Board's  (SAB)
Executive Committee net with representatives of the Health Effects
Institute (HEI) to discuss  several issues of mutual interest, including
ways in which both SAB and  HEI can work together to further-  our
common goal of  improving the adequacy of scientific data used in
Agency decision making.  The discussion was preceded by a General
Accounting Office (GAG) briefing  that summarized that organization's
recent review -of HEI,  GAO  also encouraged greater cooperation between
SAB and HEX.

     Following  these discussions, the Executive Committee reached consensus
•on the following issues:

     »  Is there a need for a acre systematic and extensive  SAB-HEI
        relationship?  The  Committee agreed that both of our independent
        organizational missions are complementary.  While HEI's  primary
        responsibility is to sponsor research and the SAB1s  role is to
        conduct scientific  reviews, both bodies request the  Agency to
        assess  scientific data needs for its  research programs before
        they independently  carry  out their respective functions*  A key
        strength of both bodies is their independence from the Agency.
        The Executive Committee believes that there is a need for a more
        systematic relationship between the SAB and HSI, but that both
        ought to continue to maintain their independence from each other
        in the  course of their mutual interaction.

     *  What specific mechanisms  should SAB and HEI use to address their
        common  needs? A reasonable balance between independence  and inter™
        action  is for SAB to regularly invite HEI selected representatives
        as observers to its reviews of EPA research programs.  This will
        enable  HEI to receive EFA prepared research needs assessment docu-
        ments,  become more  familar with how the standard setting process
        influences the definition of research priorities and receive the
        results of SAB evaluations at an earlier stage.  Reciprocally, HEI
        could periodically  brief  SAB committees on its ongoing research
        program.  Both SAB  and HEI committee  chairs and staff can supplement
        these exchanges with periodic presentations on future activities and
        plans.

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     *  Should the results of HEI studies be immediately -utilized by
        EPA prior to their publication in refereed journals?  The most
        common and authoritative form of acceptance of research results
        is publication in refereed journals.  This kind of peer review not
        only serves a quality control function but also promotes the
        dissemination of information and stimulates wider  thought and
        debate on scientific issues.  HEI has always encouraged its
        research contract recipients to submit their research results for
        publication*  In addition, HEI's internal peer review process is
        very thorough and', in many cases, is more methodical than the
        review process utilised by many scientific journals.  There can be a
        significant delay between the preparation of HEI research reports
        (following internal peer review) and the ultimate  publication of
        the research results in a journal.  Since SPA will have a keen
        interest in HEI's research in its ruleraaking activities, an
        important issue is whether to use such data before it appears in
        a refereed journal.  The Science Advisory Board concludes that,
        as a general principle, journal publication is preferable prior
        to the use of scientific data in regulatory decision making.
        The research results HEI sponsors may play a significant role in
        EPA's decision making process. Recognizing the above, the SAB
        believes chat such data should not be excluded from consideration.
        This belief, however, assumes that EPA will continue to conduct
        its own assessment of the data and make it widely available for
        public distribution and comment,  the position is  consistent with
        former Administrator Ruckelshaus' letter of November 6, 1984 to
        ae in response to a SAB report on dichloromethane*  Mr, Ruckelshaus
        stated that, "My belief is that it would not be feasible to
        exclude automatically all unpublished data since it may provide
        some insights in making health assessment/ risk management decisions.'

     I hope these views are useful to' both the Agency and do the Health
Effects Institute.

                             Sincerely,
                             Norton Nelson, Chairman
                             Executive Committee
                             Science Advisory Board
    -cci  A. James Barnes
          Donald Ehreth
          Craig Potter
          Charles Powers
          Terry F. Yosie

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