Improve Regulatory Science

Improve Regulatory Science

BACKGROUND

The new regulatory review executive order recognizes the importance of
basing regulatory decisions on strong scientific data. Many regulatory
decisions made by federal agencies are founded on scientific
judgments.[Endnote 1] For example, rules concerning limitations on
airline pilot working hours depend on physiological and behavioral
science concerning human sleeping needs.[Endnote 2] The "age-60"
limitation for commercial pilots depends on scientific judgments about
aging and health risks.[Endnote 3] A myriad of Environmental Protection
Agency (EPA), Occupation Safety and Health Administration (OSHA), and
Food and Drug Administration (FDA) rules and enforcement actions depend
on the adequacy of scientific judgments made by the agency.

To assist in making scientific judgments, agencies rely on both in-house
scientific expertise and outside scientists. Agencies employ scientists
both in staff advisory positions and in laboratories and research
centers.[Endnote 4] Agencies must nurture in-house scientific expertise
and attract top-flight scientists as employees.[Endnote 5] Regulatory
agencies have also recognized that it is necessary to use outside
scientific expertise--through the use of specialized scientific advisory
committees, referral to the National Academy of Sciences, or hiring of
scientific research consultants.[Endnote 6] In addition, the National
Institute of Standards and Technology (in the Department of Commerce)
provides scientific advice to other agencies through interagency
coordination.[Endnote 7] All of these approaches have their place, and
agencies need to have the flexibility to use them.

Generally speaking, however, agency regulatory decisions are made by an
agency head who is normally not a scientist, relying on the advice of
program officials, administrative law judges, and agency general
counsels. When decisions are challenged in court, they are reviewed by
judges, who rarely have scientific training. This process is
understandably regarded as deficient among scientists who follow the
regulatory process.[Endnote 8]

This is not a new problem. In the 1970s, proposals were advanced for a
"science court" procedure to determine "the best available scientific
judgment" for regulatory purposes.[Endnote 9] The premise was that
scientific and technical determinations could be separated from the
political and social decisions entrusted by Congress to the federal
regulatory agencies. If so, proponents argued, a panel of eminent
"scientist-judges" would be better equipped to render a decision on the
scientific merits than non-scientist government officials. Subsequently,
those officials would deal solely with the socio- political choices, but
in a scientifically informed manner.

Science court proposals have since withered on the vine, largely because
it is doubtful that scientific and policy issues can be separated--in
part because the process of defining the problem is often subjective and
frequently laden with political considerations.[Endnote 10] This is
particularly true in connection with risk assessment decisions, which
often arise in emotionally charged contexts such as food safety or
occupational or environmental exposure to carcinogens, poisons, or
radiation. Another approach to the problem has, however, been developed:
the science advisory board.

EPA's SCIENCE ADVISORY BOARD. The EPA has developed the most
sophisticated, wide-ranging science board among the agencies. The
Science Advisory Board (SAB) in its present form was established in 1978
by statute, although predecessor bodies date back to the early
1970s.[Endnote 11]

As a federal advisory committee, the SAB must comply with the Federal
Advisory Committee Act and related regulations. Consequently, the Board
has an approved charter and must hold public meetings.[Endnote 12] The
SAB charter provides a succinct statement of the Board's purpose: "The
objective of the Board is to provide advice to EPA's Administrator on
the scientific and technical aspects of environmental problems and
issues."[Endnote 13]

At present the SAB consists of an Executive Committee and 10 Committees
made up of 80 members, plus 300 "consultants" who serve on an "as
needed" basis.[Endnote 14] The SAB operates within EPA as a staff office
reporting directly to the administrator, directed by a career Senior
Executive Service (SES) Executive Director and 16 other staff members.
Its budget is approximately $1.7 million.[Endnote 15]

The Board's activities are quite varied. It takes on reviews of
scientific issues relating to EPA's mandate at the request of Congress,
the administrator, and program offices as well as on its own initiative.
In recent years, the Executive Director has issued an annual agency-wide
solicitation of issues.[Endnote 16] Most of the Board's work-product
consists of reports--most often as a result of a requested peer review
of an agency document which includes findings, recommendations, and
answers to specific questions addressed to the Board. Perhaps the most
influential and celebrated SAB report was Reducing Risk, produced in
1990 by a special Relative Risk Reduction Strategies Committee. Such
reports typically carry a disclaimer which restates the Board's
independence within the agency.[Endnote 17]

Beyond its important role in furthering EPA's risk prioritization
activities, the recent Board reports cover a mix of highly technical
(e.g., Review of the Drinking Water Criteria Document for
Cryptosporidium) and not-so-technical (e.g., Review of the draft revised
Homebuyer's and Seller's Guide to Radon) reviews. They also show an
increasing interest in forward-looking, strategic issues (e.g., Review
of the Office of Research and Development's Bioremediation Research
Program Strategy).[Endnote 18] To channel this sort of constructive
criticism, Administrator Carol Browner has requested that the Board help
the agency anticipate future environmental problems. The Board has
accepted this request and is organizing a new Committee, the
Environmental Futures Committee, to undertake this effort.[Endnote 19]

THE FDA SCIENCE BOARD. FDA houses several national research centers
(e.g., the Center for Biologics Evaluation, the Center for Drug
Evaluation and Research, and the Center for Devices and Radiological
Health). The agency has also historically relied on about 40 highly
particularized advisory committees to assist these centers in looking at
particularized products, such as over-the-counter drugs, blood products,
or ophthalmic devices.[Endnote 20] As Commissioner David Kessler told
the National Performance Review, "Virtually every licensing decision of
any significance in the agency is put before a scientific advisory
committee."21

Because of the importance of science advisory committees in the agency,
the Commissioner in June 1992 established the "Science Board to the Food
and Drug Administration."[Endnote 22] The Board consists of 12
distinguished members (eight from academia, three from corporations, and
one from a foundation). Other temporary members or consultants may be
called upon to serve when needed, and temporary subcommittees are
authorized. The Board's Charter provides a broad mandate to provide
advice on specific technical issues and emerging, evolutionary, research
questions.[Endnote 23]

In his remarks at the Board's first meeting, Commissioner Kessler
restated his hope that the Board will tackle important cross-cutting
scientific issues:

FDA convenes a variety of advisory panels. But this one is different
from most. For the work you do will go beyond one product or one crisis.
You are being asked to influence the very foundation of this agency's
work...for decades to come.[Endnote 24]

Need For Change

As the Carnegie Commission study Improving Regulatory Decision Making
states in commending the activities of the EPA and FDA boards, "External
science advisory boards serve a critically important function in
providing regulatory agencies with expert advice on a wide range of
issues."[Endnote 25] Yet, with a few other exceptions, most regulatory
agencies have not organized science advisory boards.[Endnote 26]

Creation of such science advisory boards not only should produce
regulatory decisions and agenda setting that are founded on better
science, they should also induce greater acceptance of those decisions
by Congress, the courts, the general public and among scientists
themselves.

Regulatory agencies need help in making decisions that must be made in a
context of significant scientific or technical uncertainty. Recent
hard-to- predict questions have arisen, for example, concerning the
permeability of different grades of latex to the AIDS virus or the
possible risks posed by the sodium azide used in airbags when cars are
junked. Given the difficulty in attracting top scientists into full-time
government staff positions, the best way to tap into their expertise to
answer these kinds of questions is to leverage the low costs of travel
and government per-diem rates into formation of a part-time science
advisory board.

 
Cross-References To Other Npr Accompanying Reports

Environmental Protection Agency, EPA10: Promote Quality Science for
Quality Decisions.

National Science Foundation/Office of Science and Technology Policy,
NSF01: Strengthen Coordination of Science Policy.

Endnotes

1. Nyhart, J.D., and Milton M. Carrow, Law and Science in Collaboration
-- Resolving Regulatory Issues of Science and Technology (Lexington, MA:
Lexington Books, 1983).

2. 14 C.F.R.    121.470-121.525; 14 C.F.R 135.261-135.271.

3. 14 C.F.R.   121.383(c).

4. For example, the Environmental Protection Agency (EPA), where the
Administrator and many of the Assistant Administrators have official
science advisors, or the Food and Drug Administration (FDA), which
employs scientists in its highly praised research centers. But see
Mashaw, Jerry L., and David L. Harfst, The Struggle for Auto Safety
(Harvard University Press 1990), p. 197, describing the National Highway
Traffic Safety Administration's Ohio test facility as "NHTSA's version
of Siberia."

5. See Carnegie Commission on Science, Technology and Government
(Carnegie Commission), Risk and the Environment: Improving Regulatory
Decision Making (Washington, D.C., June 1993), p. 91.  The quality of
the research, development, and assessment at all regulatory agencies can
be substantially improved. To do so, agencies must recruit and retain
first-rate scientists and engineers, provide them with state-of-the-art
facilities and equipment, and give them the resources necessary to carry
on research of the highest quality.  Where internal capabilities are
weak, bridges should be built to allow access to the best scientists and
engineers in academic and nongovernmental organizations.

6. See for example, Food and Drug Administration Advisory Committees,
Institute of Medicine (National Academy of Sciences, 1992). The
Institute of Medicine found the existing FDA advisory committee system
to be "fundamentally sound." Id. at vi.

7. The Department of Commerce cites the following examples of the
National Institute of Standards and Technology (NIST) interagency
projects:
 --provided fire-endurance testing and analysis to help the Nuclear
Regulatory Commission regulate fire barrier systems in nuclear power
plants; --developed, for EPA, a program to identify private laboratories
with the capability needed to analyze asbestos fibers and give them
technical support; and --worked with FDA scientists, using the NIST
research nuclear reactor, to research use of nuclear techniques to
analyze and help regulate food content, such as chlorine in cooking oil
and iodine in eggs.
 Memorandum from Gloria Gutierrez, Acting Chief Financial Officer and
Assistant Secretary for Administration, Department of Commerce, to
Jeffrey Lubbers, August 5, 1993.

8. Dr. Sheila Jasanoff, Director of Cornell University's Program on
Science, Technology, and Society, opines, "Over the past twenty years,
federal regulatory agencies have developed a reputation for slipshod
science." Jasanoff, Scientific Review and Agency Decisionmaking, issue
paper prepared for the Carnegie Commission on Science, Technology and
Government, supra note 5 (1989), p. 1.

9. Symposium, "Twenty-five Year Retrospective on the Science Court,"
Risk, vol. 4, no. 2 (Concord, N.H.:  Franklin Pierce Law Center, Spring
1993).

10. Cranor, Carl F., "Science Courts, Evidentiary Procedures and Mixed
Science-Policy Decisions," Risk, vol. 4, no. 2 (Spring 1993), p. 113.

11. The Environmental Research, Development and Demonstration
Authorization Act, 43 U.S.C.   4365 (1988).

12. 5 U.S.C. App. (1988).

13. Environmental Protection Agency, Advisory Committee Charter for
Science Advisory Board (November 8, 1991), reprinted in Environmental
Protection Agency, Science Advisory Board, FY 1992 Staff Director's
Annual Report, "Getting Results," p. A-2. Elaborate Board guidelines
provide criteria and procedures for selection of members and
consultants, terms of appointment, assignment of topics to committees
and subcommittees, and rules concerning conflicts-of-interest and public
disclosure of members' and consultants' interest in assigned topics.
"Guidelines on Service on the Science Advisory Board," id. at Appendix
D.

14. The 10 committees cover the major environmental media (Clean Air
Scientific Advisory Committee,* Radiation Advisory Committee, Indoor Air
Quality Committee,* and Drinking Water Committee), environmental effects
(Ecological Processes and Effects Committee and Environmental Health
Committee), analytical issues (Environmental Engineering Committee,
Research Strategies Advisory Committee, Clean Air Act Compliance
Analysis Council,* and Environmental Economics Advisory Committee).
[Asterisked committees are mandated in separate statutes.] See FY 1992
Staff Director's Final Report, pp. 9-10.

15. Ibid., p. 2 (Fiscal Year 1992 Budget).

16. Interview with Donald G. Barnes, Staff Director, Environmental
Protection Agency, July 7, 1993.

17. A recent draft Science Advisory Board (SAB) report carries the
standard disclaimer:  This report has been written as a part of the
activities of the Science Advisory Board, a public advisory group
providing extramural scientific information and advice to the
administrator and other officials of the Environmental Protection
Agency. The Board is structured to provide balanced, expert assessment
of scientific matters related to problems facing the Agency. This report
has not been reviewed for approval by the Agency and, hence, the
contents of this report do not necessarily represent the views and
policies of the Environmental Protection Agency, nor of other agencies
in the executive branch of the Federal government.  Environmental
Protection Agency, Review of the Methodology for Developing Ambient
Water Quality Criteria, SAB-DWC-93XXX (1993).

18. The reports mentioned in this paragraph are listed in FY 1992 Staff
Director's Annual Report, supra note 13, Appendix G.

19. See note 16 in REG07 and accompanying text. The Board has also shown
a commendable willingness to reexamine its operations and role within
EPA. A 1989 report, The Mission and Functioning of the EPA Science
Advisory Board, constructively reviewed all aspects of the SAB, and has
helped its Executive Committee and Staff Director improve the Board's
performance and its influence within EPA.  (Subcommittee report accepted
by SAB Executive Committee on October 23, 1989.)

20. See Food and Drug Administration Advisory Committees, supra note 6
pp. 33, 82-83.

21. Telephone interview with David Kessler, Commissioner, Food and Drug
Administration, July 12, 1993.

22. Department of Health and Human Services, Food and Drug
Administration, Charter -- Science Board to the Food and Drug
Administration (June 26, 1992), p. 1.

23. The Board's charter reads as follows:  The Board shall provide
advice primarily to the Agency's Senior Science Advisor and, as needed,
to the Commissioner and other appropriate officials on specific complex
and technical issues as well as emerging issues within the scientific
community in industry and academia. Additionally, the Board will provide
advice to the agency on keeping pace with technical and scientific
evolutions in the fields of regulatory science; on formulating an
appropriate research agenda; and on upgrading its scientific and
research facilities to keep pace with these changes.  It will also
provide the means for critical review of agency sponsored intramural and
extramural scientific research programs.

24. Remarks by Commissioner David Kessler to Science Board Advisory
Meeting, Washington, D.C., February 2, 1993, pp. 6-7.

25. Carnegie Commission, p. 90. The Commission went on to caution,
however, that agencies should not rely so heavily on external advice
that they neglect the development of internal scientific expertise.

26. See Smith, Bruce L.R., The Advisers -- Scientists in the Policy
Process, (Washington D.C.: The Brookings Institution, 1992), which
describes the other, similar boards used to review research and
development matters or research issues (Defense Science Board, Energy
Research Advisory Board, NASA Advisory Council, and a bureau with the
State Department). An NPR survey disclosed that the Minerals Management
Service with the Department of Interior also has a science board.