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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