Rulemaking that Depends on Scientific Information

Create science advisory boards. (1)

The President should require that heads of regulatory agencies that
conduct rulemaking or other proceedings that depend heavily on
scientific information and judgments create a science advisory board or
explain why such a board is not needed.

Agencies which face scientific issues in research and development rather
than regulatory contexts may have other options such as the Federal
Coordinating Council for Science, Engineering and Technology (FCCSET)
(proposed for reconstitution as the National Science and Technology
Council by NPR).[Endnote 27] Furthermore, regulatory agencies all have
differences that may lead to different approaches to considering or
creating such a board. FDA's reliance on scientific advisory committees
led to a small overarching board, while EPA has an 80-member board with
10 committees. But all agencies, especially those with regulatory
mandates involving risk-related questions, should consider creating a
board that meets their specific needs.[Endnote 28]

Agencies with less frequent or less pressing scientific issues may wish
to use established boards in other agencies. A fee-for-service program
should be developed to foster this approach. Moreover, agency science
boards should be linked to one another, perhaps under the sponsorship of
the Regulatory Coordinating Group or the President's Office of Science
and Technology Policy (OSTP).[Endnote 29] Such a linkage will facilitate
synergy among the boards and will help agencies identify cutting-edge
and other issues that would benefit from review by a quasi-independent
board of outside scientific experts.

Agencies that do create such boards need to pay attention to their staff
support as well.[Endnote 30] They need not be expensive propositions.
Although EPA's mega-board has an annual budget of $1.7 million, the
charter for the FDA Board estimates the annual cost of travel,
compensation, and staff support to be less than $100,000. Both of these
amounts seem like bargains, given the tremendous cost implications of
EPA and FDA scientific decisions.

Endnotes

27. Federal Coordinating Council for Science, Engineering and Technology
(FCCSET) was established in 1976 along with the White House Office of
Science and Technology Policy (OSTP). According to the Carnegie
Commission's study, "FCCSET's influence has varied over the past
decade." Carnegie Commission report, supra, note 6 at p. 40. NPR is
recommending that the President issue an executive order and propose
legislation to reconstitute FCCSET into the National Science and
Technology Council, giving it a broader role in setting since and
technology policy.  See NPR Accompanying Report, National Science
Foundation/Office of Science and Technology Policy, "NSF01: Strengthen
Coordination of Science Policy."

28. This follows the recommendation of the 1983 National Academy of
Sciences report, Risk Assessment in the Federal Government: Managing the
Process (May 1983), Recommendation 3, p. 156. See also the proposal by
the American Industrial Health Council (AIHC) that the Occupational
Safety and Health Administration (OSHA) create a science advisory
committee, AIHC Proposal for an Ad Hoc OSHA Science Advisory Committee
(August 28, 1990).

29. The Carnegie Commission report suggested that OSTP play a leading
role in policy decisions involving scientific and regulatory decisions.
Carnegie Commission, p. 47.

30. With respect to staffing, Bruce Smith has argued:  At a minimum the
necessary elements seem to include the following: a full-time
secretariat consisting of several persons; additional staff support,
preferably drawn from the rest of the agency, for each separate task
group established; an adequate budget, including some funds for travel,
consultants, and contract research; and a career pattern within the
agency that makes a support role to the advisory board a desirable
assignment (both for promising younger officials and for senior people).
The advisory board's secretariat should comprise persons with enough
stature to permit easy interaction with other senior executives in the
agency (both appointive and career) and with the committee members.
Smith,The Advisers, p. 205.