Archive

Improving Regulatory Systems

Recommendations and Actions

REG08: 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.

ACTION

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.

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.

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.

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