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                Accompanying Report of 
            the National Performance Review
                   Washington, DC
                   September 1993

Improve Regulatory Science


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 sociopolitical 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]


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-topredict 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.


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.


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.


  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
  5. 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."
  6. 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.
  7. 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.
  8. 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.

Improve Agency and Congressional Relationships


Much of what an agency can or cannot do to solve a problem is dependent on the legislation that Congress passes requiring or authorizing an agency to take action. Agencies often complain that statutory constraints imposed by Congress are major impediments to more efficient, effective, and sensible regulation.

Legislation that is overly restrictive, too detailed, or poorly conceived or drafted leads to a number of problems. It can force agencies to spend resources on minor or nonexistent problems while major problems remain unaddressed. It is normally the agency that is blamed for issuing "bad" regulations--the agency's defense that Congress gave the agency no choice may not be heard.[Endnote 1] "Bad" regulations gradually destroy the credibility of the agency and are likely to make even its good regulations less acceptable.

Problematic legislation comes in a variety of forms. First, legislation may require an agency to issue regulations that do not solve a problem and, therefore, do not benefit society at large. For example, the Surface Transportation Assistance Act of 1982 required the Secretary of Transportation to issue regulations requiring "splash and spray suppression devices" (fancy mud flaps) on trucks to decrease the amount of spray from trucks that could hinder visibility for car drivers.[Endnote 2] The Department of Transportation's (DOT) testing determined that the fancy mud flaps decreased the amount of spray on car windshields to such a slight degree that it did not improve the car driver's visibility and, thus, had no safety benefits. DOT, however, had no alternative other than requiring fancy mud flaps or seeking a statutory change.[Endnote 3]

Second, overly restrictive legislation does not allow agencies to change regulations as circumstances change. For example, Congress may require a regulatory scheme based on a particular assumption of cause and effect. If further research shows that assumption to be false, the agency may not be allowed to change its approach accordingly and may impose unnecessary costs on the economy.

Third, legislation that requires command-and-control or overly detailed regulation may be preventing the agency from using or developing an innovative approach that would be more effective or efficient.

Fourth, legislation may impose unrealistic (if not outright impossible) deadlines, which either make the agency look bad when the deadlines are not met or may preclude the agency from doing the necessary background work for the rule.[Endnote 4] In 1990, the General Accounting Office studied three statutes that required the Department of Education to issue 83 regulations in 240 days. The sheer volume and complexity of the legal and policy issues involved made it virtually impossible for the Department to issue the regulations within the statutory timeframe.[Endnote 5]

Fifth, legislation may have unintended consequences. For example, a statute might inadvertently preclude the most common device for meeting a statutory goal by setting requirements that the device cannot meet.


Legislation that is overly restrictive, too detailed, or poorly conceived or drafted results from a variety of circumstances, some of which are not unique to the regulatory process--distrust between the executive and legislative branches, lack of congressional technical expertise, congressional failure to understand the difficulties in implementing a regulatory program, and lack of common understanding of complex issues between the legislative and executive branches. This general problem as it relates to regulatory problems is briefly discussed here. A more comprehensive discussion of relations between the executive and legislative branches and recommendations for improving them is contained in the National Performance Review Accompanying Report Creating Quality Leadership and Management.[Endnote 6]

Distrust between executive and legislative branches is one of the major reasons for legislation that is overly restrictive, too detailed or poorly conceived or drafted. Some tension in the relationship between Congress and the executive branch is inherent in our system (especially when two branches are controlled by different political parties). Agencies should perceive Congress as an entity that imposes constraints on the executive. That is a result of the checks and balances established in the Constitution.

Nonetheless, the tension between the executive branch and Congress has risen too high.[Endnote 7] A panel of the National Academy of Public Administration recently concluded that, "[t]he outright confrontation and increasingly competitive relationship between the two branches has a high cost: a political system more and more unresponsive to national problems and unaccountable to the American people for addressing those problems."[Endnote 8] It is time to find a better balance.

Congressional distrust of agencies affects legislation in a variety of ways. In the past decade, Congress was motivated to write overly prescriptive legislation because it feared that an administration that disagreed with congressional policies and goals would substitute administration policy for congressional policy when statutes were ambiguous or flexible.[Endnote 9] Congressional concerns about agencies' inability to issue regulations in a timely fashion, exacerbated by the perception that the Office of Management and Budget (OMB) was holding up agency rules, resulted in Congress imposing statutory deadlines with "hammers" (like that for the food labeling rule) that would impose rigid statutory obligations on private parties if the deadlines were not met.[Endnote 10]

Some problems in legislation also result from a lack of understanding about how agencies work, emerging issues, or the arcane details of existing programs. Very few Members or Hill staffers have worked in agencies or appreciate the complexities of implementing the statutes they write. Agencies have expertise that Congress lacks in specific fields and about the details of existing programs. Although many Members and Hill staffers become quite knowledgeable about programs they oversee, when new issues or scientific breakthroughs occur, Congress and the administration (as well as federal judges) often lack a common understanding of the problems and emerging issues (including an understanding of where the experts disagree).[Endnote 11]

When the administration supports legislation, agency staff provide technical expertise and drafting advice to Congress. This help can be very useful to Congress and, thus, to the agency. It sometimes comes too late, however, because of the time it takes to reach an administration-wide policy on legislation.[Endnote 12] In addition, in the past, some agencies refused to give assistance if the administration disagreed with the legislation. When such legislation passed, though, agencies had to implement it--whether or not they had been able to correct technical glitches.

Other agencies have taken steps to diminish drafting problems, even with legislation with which the administration disagrees. The Department of Agriculture provides a technical drafting service to Congress. Upon written request from a member of Congress or a congressional committee, staff attorneys in the Office of the General Counsel will draft proposed legislative language implementing the requested policy. After clearance within the General Counsel's office, the proposed language is sent back to Congress. The Department makes it very clear that, even though its staff has drafted the legislation, that does not mean that the administration supports the legislation. The service is provided to all requesters regardless of the administration's position.[Endnote 13] The U.S. Fish and Wildlife Service and the Minerals Management Service of the Department of Interior provide similar services.[Endnote 14]

In addition to enhancing an agency's relationship with Congress, providing technical drafting cuts down on the unintended consequences of legislation. When the policy goal is to change a program only partially, the agency's experts are more likely to know how to limit or minimize changes to other parts of the program. The agency's experts should also be more sensitive to implementation problems.

At first blush, it may seem strange to offer to draft legislation with which the agency may disagree, but USDA, the Fish and Wildlife Service, and the Minerals Management Service do not believe that doing so has resulted in legislation passing that would not otherwise have done so.[Endnote 15] Although helping to draft legislation does provide some assistance to the legislation's proponents, it also helps the agency. If the agency experts do not draft or comment on statutory language, it is likely to be written by someone with less understanding of the program, of the ramifications of the legislation, and of implementation problems.


Establish technical drafting services for congressional committees and subcommittees. (1)

Agency heads should require their agencies to provide technical drafting services to chairs and ranking members of congressional committees and subcommittees and to the House or Senate Office of Legislative Counsel as a method of avoiding unintended consequences of legislation. It is important that such service be provided regardless of the administration's substantive policy position. If responses have to wait for determination of administration policy, such a service would not be effective because it will not provide timely input into the legislative process. Because an agency may have to implement legislation with which it disagrees, it should strive to fix technical glitches that may cause implementation problems. Furthermore, if the agency provides the service to all comers, responses cannot be interpreted as an early indication of administration support (which could happen if agencies only provided assistance in response to select requests).

To ensure that it is the agency, rather than the individual staff members, assisting Congress, the service should have the following safeguards built in:

--An agency will designate an office or senior agency official (perhaps the congressional liaison office or the general counsel's office) as the clearinghouse for all technical drafting services.

--Although legislative language normally would be drafted or revised by the agency's technical experts, it should then be cleared by an appropriate senior agency official (or officials). Given the timesensitive nature of the legislative process and the fact that policy clearance is not needed, the number of levels of clearance should be very limited.

--Requests for statutory language and responses containing such language will be in writing.

--Upon providing the response, the agency shall instruct the congressional committee to disclaim that technical drafting services indicate administration support.


Rethinking Program Design, DES01: Activate Program Design as a Formal Discipline.

Creating Quality Leadership and Management, QUAL04: Improve Legislative-Executive Branch Relations.


  1. For example, President Bush faced a very difficult political problem in the summer and fall of 1992. The National Corn Growers Association and the ethanol industry claimed that a rule proposed by the Environmental Protection Agency (EPA) would preclude ethanol mixed with gasoline from meeting a federally ordered program requiring cleaner-burning reformulated gasoline. They wanted EPA to allow a special waiver for gasoline mixed with ethanol. The fact that the Clean Air Act did not allow EPA to grant the requested waiver did not stop this political pressure, nor did it stop a Sense of the Senate resolution [Congressional Record, Senate (September 8, 1992), p. S12893] that criticized the Bush Administration's proposed rule. Rosewicz, Barbara, "Big Ethanol Problem for Bush Prompts White House to Mull Special Concessions," The Wall Street Journal (September 8, 1992), p. A3; Babcock, Charles R., "Bush's Sidestep on Ethanol's Fueling Dispute," The Washington Post (September 28, 1992), p. A3.
  2. 414 of Pub.L. 97-424, 49 U.S.C. App. 2314 (1988).
  3. The Department of Transportation (DOT) eventually succeeded in getting this requirement modified (Surface Transportation and Uniform Relocation Assistance Act of 1987, Pub.L. 100-1 205). Seeking repeal or modification of problematic statutory requirements can be a difficult task, particularly where the requirements are part of a statute that required a great deal of political compromise to pass initially.
  4. Administrative Conference of the U.S., Recommendation 78-3, "Time Limits on Agency Actions," 1 C.F.R. 305.78-3.
  5. U.S. General Accounting Office, Education Regulations: Reasons for Delays in Issuance, GAO/HRD- 91-4BR (Washington, D.C.: U.S. General Accounting Office, November 15, 1990), pp. 1-2.
  6. See "QUAL04: Improve Legislative-Executive Branch Relations," NPR Accompanying Report, Creating Quality Leadership and Management (Washington D.C.: U.S. Government Printing Office).
  7. Broder, David S., "Hill's Micromanagement of Cabinet Blurs Separation of Powers," Washington Post (July 25, 1993), pp. A1, A16, A17.
  8. A Panel of the National Academy of Public Administration, Beyond Distrust: Building Bridges Between Congress and the Executive (Washington, D.C., January 1992), pp. 2-3.
  9. The motivation to grant agencies only very limited discretion may have been increased by the Supreme Court's decision in Chevron USA, Inc. v. NRDC, 467 U.S. 837 (1984), which said that a court would uphold an agency's reasonable interpretation of its statute if the statute was not clear on its face.
  10. When Congress passed the Nutritional Labeling and Education Act of 1990, Pub. L. 101-535, it was "tired of what it regarded as the Food and Drug Administration (FDA) and White House foot-dragging on important regulations." Gladwell, Malcolm, "Interagency Fight Puts Overhaul of Food Label Rules on Bush's Plate," Washington Post (November 15, 1992), pp. A1, A24. The statute gave FDA one year to issue a proposed labeling rule and another year to finalize it. 2(b)(1) of the Act. If the final rule deadline was missed, the "hammer" fell and FDA's proposed rule would become effective. 2(b)(2) of the Act. When this occurred at the end of 1992, it caused confusion among the industry and the public, and even greater risk of litigation over the eventual final rule.
  11. Carnegie Commission on Science, Technology, and Government, Risk and the Environment: Improving Regulatory Decision Making (Washington, D.C., June 1993), pp. 54-63.
  12. Interview with House Government Affairs Committee Staff, June 8, 1993.
  13. Telephone interview with James Michael Kelly, Associate General Counsel, Department of Agriculture, August 16, 1993.
  14. Telephone interview with Owen Ambur, Chief, Office of Legislative Services, U.S. Fish and Wildlife Services, Department of the Interior, July 22, 1993; telephone interview with Stephen Shaffer, Chief, Congressional and Legislative Affairs, Minerals Management Services, Department of the Interior, July 22, 1993.
  15. Telephone interviews with James Michael Kelly, Owen Ambur, and Stephen Shaffer, see supra notes 13 and 14.

Provide Better Training and Incentives for Regulators


A regulatory system is only as good as the people implementing it. A well-trained and informed cadre of regulatory officials is crucial for an efficient, innovative regulatory system, that emphasizes choice of the appropriate regulatory approach. Inadequate training can result in errors, no matter how intelligent and well-meaning the officials may be. No current programs provide the training necessary to effect the needed major changes in the federal government's regulatory culture.[Endnote 1] Proper training and performance incentives are needed to ensure that the agency officials involved in regulatory activities are as effective as possible.

As is well known, presidential appointees have widely diverse backgrounds and familiarity with the federal government. Many (but not all) are well-versed in their agency's substantive program, but few appointees can be expected to know, at the time of their appointment, the details of the arcane statutes and rules that govern the agency's rulemaking procedures.[Endnote 2] Yet a lack of understanding of these rules can slow and possibly trip the most eager of new appointees. It is crucial that this blank slate be filled quickly since studies show that nearly half of all presidential appointees leave office within two years--hardly enough time for them to develop a meaningful understanding on their own.[Endnote 3]

There have been some attempts in the past to furnish training to presidential appointees. Based on a 1975 recommendation, the Administrative Conference of the U.S. (ACUS) provided a three-day seminar for commissioners of the independent regulatory agencies in 1977.[Endnote 4] It covered a broad range of topics relating to regulation.[Endnote 5] No such systematic programs have been held since. ACUS has also more recently provided shorter, day-long or half-day programs on various aspects of administrative law and procedure relevant to regulatory commissioners. A continuing, comprehensive approach is needed, however.

Some limited training opportunities do exist for career staff. The Legal Education Institute (LEI) within the Department of Justice's Office of Legal Education presents courses for government lawyers. The Federal Executive Institute provides management training for the Senior Executive Service (SES), and some federal officials have attended courses at the Kennedy School of Government at Harvard University. A few outside firms also provide training courses. These opportunities are limited, both in number and in scope, and fall short of ensuring that all relevant personnel are familiar with the pertinent laws and processes.

Career regulators and Hill staff often lack a broad perspective about the regulatory process because career paths are often confined to one agency. Rotational assignments among agencies in the executive branch and among the branches are not common. Although some programs accomplish some of these goals for entry level officials, such as the two-year Presidential Management Intern program, there are no established inter-agency or inter-branch career paths for regulatory professionals.[Endnote 6] Such officials do not have any real incentive to seek rotational assignments, since it is the person's "home-base" agency that continues to conduct performance appraisals and absence is not likely to "make the heart grow fonder." Members of the SES also theoretically have this opportunity but they are often in such high-level positions that there is little incentive for them to seek or be permitted to accept rotational assignments.


Despite the increasing complexity of the regulatory process, little or no relevant training is currently available for regulatory officials. High-level policymakers, particularly those who are Presidential appointees, are often provided no training or background in the laws and processes they must follow, and career staff have access only to limited, and often inadequate, training opportunities.

The lack of training for presidential appointees is all the more glaring given the availability of intensive orientation to members of Congress and the federal judges.[Endnote 7] Indeed, a survey by the National Academy of Public Administration (NAPA) reported that 79 percent of presidential appointees received no orientation of any kind.[Endnote 8] As NAPA has concluded:

It is hard to imagine that anyone could regard this disinterest in the orientation of new presidential appointees as a sound way to run the federal government. We believe the historical absence of such programs is a matter of great concern, a problem that should be permanently corrected.[Endnote 9]

With respect to career regulatory staffs, the situation is only somewhat better. Training for nonlawyer career staff is hit-and-miss. The Legal Education Institute (LEI) does an excellent job of training agency lawyers on a variety of issues, a number of which relate to agency rulemaking and regulation. These courses have typically been one-day courses held in Washington, D.C. About 95 percent of the roughly 4,000 LEI attendees in 1991 were from Washington, D.C.[Endnote 10] Rather than having its own paid teaching staff, the institute typically relies on professionals from throughout the government to volunteer to teach courses in their areas of expertise.

Unfortunately, recent Department of Justice appropriations legislation required the Institute to be moved to Columbia, South Carolina, as part of a move of the entire Office of Legal Education.[Endnote 11] As a result, it is expected that either attendance by agency staff lawyers will drop significantly or training costs will rise significantly to cover the increased travel costs to send personnel to South Carolina (as opposed to across town).[Endnote 12] Moreover, LEI's travel expenses for faculty would increase, since almost 95 percent of the faculty were from Washington, D.C., and it is unlikely that as much of the necessary administrative law and regulatory expertise would be locally available in South Carolina.

In addition to training, a broad outlook on regulatory issues and first-hand awareness of a variety of perspectives can be extremely useful in developing regulatory programs. Providing select midlevel career staff an opportunity to spend time at different agencies, on Capitol Hill, at the Office of Management and Budget (OMB), and/or in the judicial branch would provide those people and their agencies with extremely useful expertise for effective implementation of regulatory programs. They would discover how other agencies approach similar problems, what Congress' perspectives are, how the judiciary looks at regulatory issues as they come before the courts, and how OMB approaches problems of regulation. In addition, the quality of communication and coordination among agencies, Congress, and OMB might be improved through increased and ongoing contact. Also, the Office of Information and Regulatory Affairs (OIRA), as a centralized locus for regulatory review, could be a place to train agency staff. Agency staff could learn not only what Presidential review entails and the technical skills involved in regulatory analysis, but also how other agencies address various regulatory problems.

The need for this type of rotation has been increasingly recognized. Judge Stephen Breyer, in his new book on improving risk regulation, called for a "circulating career path" for "(eventual) high level executives," modeled on France's Conseil d'Etat.[Endnote 13] As Judge Breyer visualized it, an OMB "special group" could be created with a special civil service career path leading though agencies, congressional committee staffs, back to OMB, with possible presidential appointments for the most successful members. Such a concept would not only augment OMB (especially OIRA's capabilities), it would "seed" the government with experts in broader regulatory issues.


  1. Establish a basic training program for Presidential appointees to regulatory agencies. (2)

The President should direct political appointees to regulatory agencies to attend a comprehensive training program on the issues and processes involved in regulatory development. The President should direct ACUS, which has expertise in the administrative adjudication and rulemaking processes and access to experts across the federal government and academia, to establish such an ongoing training program for presidential appointees. Among the topics that should be included in the curriculum are:

--role and organizations of regulatory agencies,

--personnel management,

--alternative regulatory approaches,

--the budget process,

--program evaluation,

--policy formation and the rulemaking process,

--the Administrative Procedure Act and various other applicable statutes and executive orders,

--the relationship between agency rulemaking and settlement,

--the relationship between regulatory agencies, the White House and OMB,

--cost-benefit analysis use (but not abuse),

--judicial review,

--relationships with the public, the press, and the state and local governments,

--regulatory reform, and

--alternative dispute resolution.[Endnote 14]

Faculty could include representatives. from the White House, Congress, various federal agencies, the federal judiciary, OMB, academia, and industry. Training programs should ideally be held at a site outside of Washington and should last for at least three days. They should be organized on a periodic basis, most frequently in the first half of the administration as new appointees are nominated or confirmed.

2. Move training programs for agency regulatory lawyers back to Washington, D.C., and expand to cover other career staff. (3)

Legislation should be enacted to move the Legal Education Institute (LEI) back to Washington, D.C. LEI should be expanded to non-lawyer career staff. Moving LEI back would generate substantial cost savings, some of which could be used to expand the program.[Endnote 15] Moreover, the administration should consider whether to incorporate LEI into ACUS, since a large portion of LEI's courses relate to various aspects of administrative law and process, which are ACUS's areas of expertise. In fact, ACUS currently coordinates several LEI courses. LEI's existing courses, supplemented with more focused ones on, for example, alternative dispute resolution techniques, could provide some of the necessary training for federal career regulatory officials.

3. Establish an "honors" rotation program for select mid-level career staffers. (1)

As the Carnegie Commission recently recommended:

The federal government should use its existing personnel authority to create opportunities for selected individuals to rotate in the early years of their career through environmental and risk-related regulatory agencies, Congress, the Executive Office of the President, and, in some instances, administrative offices of the Judiciary.[Endnote 16]

The Chair of the Regulatory Coordinating Group, in coordination with the Office of Personnel Management, should be charged by the President with developing an "honors" rotation program for select mid-level agency and congressional career staff involved in regulatory programs. In the meantime, key agencies with crossgovernment mandates like OIRA in OMB should develop, on their own, strategies for rotating and exchanging staff with regulatory agencies.

4. Reward innovative regulators. (1)

The heads of regulatory agencies should ensure that achievements by federal officials in performing regulatory functions are rewarded, through performance appraisals, bonus systems, and awards. Performance appraisals and bonus systems within agencies should recognize achievements in innovative, consensus-based, and effective regulation.


Reinventing Human Resource Management, HRM04: Authorize Agencies to Develop Incentive Award and Bonus Systems to Improve Individual and Organizational Performance; and HRM11: Strengthen the Senior Executive Service so that It Becomes a Key Element in the Governmentwide Culture Change Effort.

Creating Quality Leadership and Management, QUAL02: Improve Government Performance Through Strategic and Quality Management; and QUAL03: Strengthen the Corps of Senior Leaders.

Streamlining Management Control, SMC04: Increase the Effectiveness of Offices of General Counsel.


  1. See generally Adler, Robert S., Stephen H. Klitzman, and Richard A. Mann, "Shaping Up Federal Agencies: A Basic Training Program for Regulators," Journal of Law & Politics, vol. VI, no. 2 (Winter
  2. [hereinafter "Shaping Up Federal Agencies"].
  3. For a description of 18 such statutes, see Administrative Conference of the U.S., Federal Administrative Procedure Sourcebook, 2nd ed. (Washington, D.C., 1992).
  4. National Academy of Public Administration (NAPA), "Leadership in Jeopardy: The Fraying of the Presidential Appointment System," November 1985, pp. 4-5, as cited in "Shaping Up Federal Agencies," supra note 1, p. 351.
  5. Administrative Conference of the U.S., "Statement on Strengthening Regulatory Agency Management Through Seminars For Agency Officials" (adopted June 5-6, 1975), 1 C.F.R. 310.4 (1988 ed.).
  6. Discussions with officials of ACUS. The program was discussed in "Shaping Up Federal Agencies," supra note 1, pp. 360-364.
  7. See discussion in Carnegie Commission on Science, Technology, and Government (Carnegie Commission), Risk and the Environment: Improving Regulatory Decision Making (Washington, D.C., June 1993), pp. 94-95.
  8. In this environment, regulatory appointees need and should be provided an orientation, as early as possible, in the basics of administrative law. Newly elected Congressmen are offered intensive orientation courses by the congressional leadership, by outside seminars at Harvard's John F. Kennedy School of Government or by other non-governmental organizations (NGOs). Newly appointed federal judges have similar offerings available to them at the National Judicial College (located at the University of Nevada - Reno) and by the Federal Judicial Center. Even career civil servants have at least some opportunities for intensive training (at OPM's Federal Executive Institute and the USDA Graduate School, or the Harvard JFK School). Presidential appointees, ironically, are the only major regulatory actors who do not receive orientation and basic training.
  9. NAPA, p. 20, as cited by "Shaping up Federal Agencies," supra note 1, p. 364.
  10. Ibid.
  11. Information is provided in unpublished data sheet prepared by Legal Education Institute (LEI).
  12. See H.R. 2608, 102d Cong., 1st Sess., p. 14. The Office consists of LEI and the much larger Attorney General's Advocacy Institute (AGAI) which trains assistant U.S. Attorneys drawn from all over the country. In 1991, LEI had 9 employees and an annual budget of $1.5 million while AGAI had 14 employees and a budget of $9 million. While an argument can be made for relocating AGAI, moving LEI was perhaps inadvertent. Because AGAI and LEI do not overlap and have separate staff, it would be a simple matter to separate them.
  13. Travel costs from Washington, D.C. to Columbia, South Carolina, amount to approximately $400 per student (airfare plus one day's per diem). Assuming that 4,000 students from Washington, D.C. continue to attend courses in South Carolina each year, annual additional costs would amount to $1.6 million.
  14. Breyer, Stephen G., The Vicious Circle: Toward Effective Risk Regulation (Cambridge: Harvard University Press, 1993).
  15. Discussion with officials of ACUS. The list is derived from the 1977 ACUS program discussed in "Shaping Up Federal Agencies," supra note 1, at pp. 360-64.
  16. See note 12, above.
  17. Carnegie Commission, p. 94.


Appendix A:

Description of the Executive Order
on Regulatory Reform

On January 21, 1993, President Clinton abolished the Council on Competitiveness and soon thereafter asked the Vice President to prepare recommendations for a new process of regulatory review. The Vice President convened an informal working group to develop such recommendations. The President will soon issue a new executive order to implement the needed reforms recommended by the Vice President.

President Clinton's plan to reform the regulatory review process is firmly rooted in his commitment to make government more efficient and responsive, relieve businesses of unnecessary regulatory burdens, and end special access for special interests.

The executive order on regulatory planning and review will create a process that guarantees that government regulates only when necessary, and that when it does so, it regulates cost-effectively, openly, and fairly. It also will ensure that all agencies of the federal government participate in a reexamination, across agencies, of the overall regulatory scheme currently in place to eliminate any unnecessary regulatory burden.

Putting People First

The President's plan provides a regulatory process that works for the American people, not against them--one fundamentally dedicated to improving their health, safety, environment, and well-being while encouraging economic growth and job creation. It is aimed at producing regulations that are effective, consistent, and understandable.

Regulating Only When Necessary

The process created by the executive order sets forth principles that ensure that agencies regulate only when necessary. It makes clear that alternatives, such as market incentives, are preferable to commandand -control regulations. A regulatory working group of representatives from agencies with major domestic regulatory responsibility will meet regularly to consider new, creative, and more effective alternatives and approaches to regulating.

When regulations are necessary, the order will ensure that they are designed and implemented in the most cost-effective manner, so as to maximize benefits to society and to place the smallest possible burden on those being regulated. This process imposes a sensible, balanced definition of costs and benefits to ensure a realistic assessment of impacts on the economy, the environment, and public health and safety.

Sensible Planning

The executive order creates an enhanced planning process that starts before rules are formally initiated. This process will provide early guidance about administration priorities, thus minimizing conflicts and inconsistent regulatory activities among agencies. Agencies will set priorities and assemble annual regulatory plans, thereby improving their own internal planning, and ensure that other agencies and the public are informed of their activities.

Reviewing New Regulations

This executive order recognizes the primacy of agencies in the regulatory process. It also makes clear that the Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget, will be the day-to-day entity responsible for necessary centralized review.

The centralized review process will be improved by selectively reviewing regulations. Under the review process, OIRA will review significant regulations--not every regulation. Its review will be more useful and realistic because it will be focused on the overall regulatory picture and will consider a broad definition of costs and benefits. And its review will be timely--driven by clear and appropriate time limits on review that will prevent interminable delays. There also will be a clear process for resolving the rare regulatory disputes that develop between agencies or between OMB and an agency. Such disputes will be reviewed by the President only at the request of an agency head or the Office of Management and Budget. The Vice President, aided by appropriate White House policy advisors, will advise the President in resolving these disputes.

Reviewing Existing Regulations

Too often, cumulative and unnecessary regulatory burdens hamper economic growth and job creation. In order to ease such adverse effects on U.S. citizens and the economy, a process will be established to conduct an ongoing review of existing regulations or groups of regulations. Those regulations that are cumulative, obsolete, duplicative, or inconsistent will be identified for reconsideration and revision or elimination.

This process is carefully structured to be meaningful and to get results. The agencies will be asked to prepare a specific program for ongoing review of existing significant regulations and legislation that requires regulations that should be reviewed. In addition, the Vice President, in consultation with the White House advisors, will conduct reviews of existing regulations with a cross-agency perspective, and may identify regulations to the agency for review.

Enhanced Accountability

The executive order also will enhance government accountability in a number of ways. It will clearly delineate the responsibilities of the various entities involved in the regulatory review process. The OIRA review process will be conducted in the "sunshine."

The order requires public disclosure of OIRA meetings with, or information received from, outside parties. It also ensures that the public knows of the status of all pending regulations and changes made to regulations during the OIRA review process.

The process created by the new order also will end the "back door" special interest access to the review process. The order makes clear that the President's and Vice President's roles in the review process is limited to (1) providing leadership, (2) assisting in planning, and (3) resolving disputes. They will not act on behalf of, or be the conduit for, special interests or any private parties.

Appendix B:

Summary of Actions by Implementation Category

(1) Agency heads can do alone:

REG02.2 Develop a Deskbook on Regulatory Design.

REG03.1 Increase use of negotiated rulemaking.

REG04.2 Enhance public awareness and evaluation of


REG05.1 Streamline internal agency rulemaking


REG05.2 Use "direct final" rulemaking to reduce

needless double review of noncontroversial rules.

REG05.3 Develop specifications for rulemaking


REG07.1 Rank the seriousness of environmental,

health, or safety risks.

REG07.2 Develop long-range future plans and

anticipatory approaches to regulatory problems.

REG08.1 Create science advisory boards.

REG09.1 Establish technical drafting services for

congressional committees and subcommittees.

REG10.3 Establish an "honors" rotation program for

select mid-level career staffers.

REG10.4 Reward innovative regulators.

(2) President, Executive Office of the President, or

the Office of Management and Budget can do:

REG01.1 Create an interagency Regulatory

          Coordinating Group to share information and 
          coordinate approaches to regulatory issues.

REG02.1 Establish use of innovative approaches as

administration policy.

REG04.1 Increase public participation during the

rulemaking process.

REG06.1 Increase use of alternative means of

dispute resolution.

REG10.1 Establish a basic training program for

Presidential appointees to regulatory agencies.

(3) Requires legislative action:

REG10.2 Move training programs for agency

          regulatory lawyers back to Washington, D.C., and 
          expand to cover other career staff.

(4) Good idea, but will require additional work, or

may be better suited for future action:

REG04.3 Increase use of information technology.

REG05.4 Evaluate and draft proposed legislative

changes to speed the rulemaking process.

Appendix C:

Accompanying Reports of the National Performance Review

Governmental Systems..........................Abbr.

Creating Quality Leadership and Management....QUAL

 Streamlining Management Control................SMC
 Transforming Organizational Structures.........ORG
 Improving Customer Service.....................ICS


 Mission-Driven, Results-Oriented Budgeting.....BGT
 Improving Financial Management..................FM
 Reinventing Human Resource Management..........HRM
 Reinventing Federal Procurement...............PROC
 Reinventing Support Services...................SUP
 Reengineering Through Information Technology....IT
 Rethinking Program Design......................DES

Strengthening the Partnership in

 Intergovernmental Service Delivery.............FSL
 Reinventing Environmental Management...........ENV
 Improving Regulatory Systems...................REG


 Agency for International Development...........AID
 Department of Agriculture.....................USDA
 Department of Commerce.........................DOC
 Department of Defense..........................DOD
 Department of Education.........................ED
 Department of Energy...........................DOE
 Environmental Protection Agency................EPA
 Executive Office of the President..............EOP
 Federal Emergency Management Agency...........FEMA
 General Services Administration................GSA
 Department of Health and Human Services........HHS
 Department of Housing and Urban Development....HUD
 Intelligence Community.......................INTEL
 Department of the Interior.....................DOI
 Department of Justice..........................DOJ
 Department of Labor............................DOL

National Aeronautics and Space Administration.NASA National Science Foundation/Office of

 Science and Technology Policy..................NSF
 Office of Personnel Management.................OPM
 Small Business Administration..................SBA
 Department of State/ U.S. Information Agency...DOS
 Department of Transportation...................DOT
 Department of the Treasury/ Resolution 
 Trust Corporation..............................TRE
 Department of Veterans Affairs.................DVA