25 program might be affected by the rule. The review procedure used depends to some extent on what is sought from these various offices. For example, if the agency desires a thorough legal or economic analysis, independent of any done by the rulemaking staff, then submission of a written memorandum makes sense. At the other extreme, if the agency merely wants to know if other offices have objections to the proposal, then a "sign-off" or 26 concurrence procedure would suffice. Often an in-between kind of review will be desired, in which the views of the various offices will be actively sought in order to bring diverse perspectives to bear on the rulemaking proposal, but without the formality and delay involved in requesting written submissions from the other offices. In response to Executive Order 12044, agencies took steps to strengthen intra-agency review of rulemaking proposals. Some agencies increased the responsibility of the Department Secretary's staff, while others created separate offices to oversee or monitor agency rulemaking progress. A 1980 report by the Office of Management and Budget on these efforts concluded that "the most successful approaches ensure that all bureau and Secretarial offices within a department are involved, including officials with State and local coordination or liaison responsibilities, public affairs offices, and congressional affairs staffs."27 In an earlier survey, OMB found that: [A] particularly effective technique for improving policy oversight used by some agencies is the creation of a regulations council within the agency. This is an executive 25/ Ideally, of course, these disciplines either would be included on the rulemaking staff or team or be consulted informally by the rulemaking staff during its investigation and analysis. See discussion supra, beginning at p. 87. 26/ An issue for the agency to consider is whether the other offices should be permitted to hold up action on the proposal by withholding or delaying concurrence. 27/ Office of Management and Budget, Improving Government Regulations: Current Status and Future Directions (Nov. 1980) at P. 3. committee of the agency's top level policy 3. Disqualification of individuals from participation. The question of disqualification of agency personnel from participating in rulemaking is discussed in Chapter Eight, which looks at the 29 agency process for making the final rulemaking decision. However, this topic also is relevant to agency organization and staffing during the pre-NPRM period. To summarize the discussion in Chapter Eight, the concepts of bias related to the fairness of a judicial trial or administrative adjudication have little applicability to rulemaking. Due process ordinarily does not require procedures in rulemaking more rigorous than those provided by Congress, and the APA does not mandate separation of functions for rulemaking. Therefore, agency staff members who participate in the investigation preceding rulemaking or on development of the proposed rule are not precluded from assisting the agency head in the formulation of the final rule. ves The conflict-of-interest laws could conceivably apply to agency assignment of staff to work on development of a proposed rule. It is a criminal offense for any federal government official to participate "personally and substantially" in a particular matter in which he, close relatives, associates, or prospective employers have a financial interest. In general-policy rulemaking, any link between the rule and a rulemaking staff member's financial interests is likely to be attenuated. However, whether or not the criminal conflict of interest provision applies, agencies should consider the effect any personal interests of staff members may have on the rulemaking. 28/ Office of Management and Budget, Improving Government Regulations: A Progress Report, Part I (Sept. 1979) at p. 11. 29/ See Chapter Eight at p. 185. 30/ 18 U.S.C. S 208 (1976). It is not entirely clear that this provision applies to rulemaking, see Chapter Eight at p. 189 n. 28. C. Involvement of Outside Interests or Groups. Agency organization and staffing in the pre-NPRM stage of rulemaking may be influenced by the extent to which the agency involves outside interests or groups in the rule development process. Early involvement of private groups or organizations may be especially desirable when (1) the agency lacks the means of obtaining information or expertise that is possessed by private organizations, or (2) early accommodation of diverse interests is necessary for development of a rule that will be acceptable to those it ultimately will affect. In this section we discuss some of the arrangements agencies may have with private groups or organizations during the pre-NPRM stage of rulemaking. 32 1. Offeror groups. The Consumer Product Safety Act of 197231 and the 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act each established a procedure whereby "offeror groups"--existing or ad hoc outside groups-were given the right to propose rules whenever the agency determined that some type of safety standard was needed. Under Section 7 of the Consumer Product Safety Act, once the offerors made their proposals, the Consumer Product Safety Commission (CPSC) had to select, and fund, one group to develop the proposed standardlargely without agency participation. Once drafted, the agency had to issue the offeror's proposal (or a modified version of it) as the agency's proposed rule. The offeror procedure did not work well at the CPSC. In 1978 the Act was amended to allow the CPSC to forego the offeror process, and, in 1981, the process was eliminated from the Act altogether." The offeror process under the Medical Device Amendments of 1976 is similar to that used at the CPSC, but the Food and Drug Administration has not exercised its authority to adopt mandatory standards under that statute. 31/ 33 See Chapter Two at p. 67 for citation and summary of provisions. 32/ See Chapter Two at pp. 68-69 for citation and summary of provisions. 33/ See Schwartz, The Consumer Product Safety Commission: A Flawed Product of the Consumer Decade, 51 Geo. Wash. L. Rev. 32, 57-71 (1982) for an account of the CPSC's experience with the offeror process. Interaction with voluntary standard-setting groups. Agencies charged with issuing mandatory health or safety regulations often rely on standards formulated and adopted by private standard-setting organizations, such as the American Society for Testing and Materials, The National Fire Protection 34 Association, and the American National Standards Institute." Of course, agencies may decide to adopt as mandatory standards the 35 voluntary consensus standards approved by such organizations. However, agencies also may attempt to work with a private standard-setting organization to develop a new or improved standard to include in an agency rule. This approach may give the agency access to the superior technical expertise of the private organization, as well as increase the acceptability of the agency's final rule. Though not legally binding, non-governmental standards are widely accepted and observed in many fields. Voluntary consensus standards, and the procedure used to adopt them, have been subject to criticism, including claims that the standards often are obsolete, anti-competitive, or not protective of consumer or public interests. Therefore, agencies should not uncritically accept such standards as the basis of federal regulations. A 1978 recommendation of the Administrative Conference provides guidance to agencies on structuring their interaction with organizations that develop voluntary consensus standards; on evaluating existing standards before incorporating them into rules, and on revising standards that have been 37 incorporated by reference in agency rules. 34/ See Hamilton, The Role of Nongovernmental Standards in the Development of Mandatory Federal Standards Affecting Safety or Health, 56 Tex. L. Rev. 1329, 1331-1368 (1978) for a description of these organizations and discussion of their role in society. 35/ This was done on a large-scale basis by OSHA under Section 6(a) of the OSH Act. That statute directed the new agency to adopt as mandatory standards any existing national consensus standard, unless the agency determined the standard would not improve health or safety. Compliance with that directive exposed OSHA to severe public and political criticism. See Hamilton, id. at 1388-94. 36/ See Hamilton, id., at 1373-86. 37/ ACUS Recommendation 78-4, Federal Agency Interaction With Private Standard-Setting Organizations in Health and Safety (Continued) 3. Regulatory negotiation. The increased formalization of agency rulemaking, and the polarization of viewpoints that often occurs in complex rulemaking proceedings, have stimulated the search for alternative ways to conduct rulemaking. One approach, supported by the Administrative Conference, is that of regulatory negotiation. Regulatory negotiation involves the convening of a group representing all the interests that would be affected by an agency rule on a particular subject. The group is asked to attempt to negotiate issues, with the goal of adopting a consensus proposal that will be published as the agency's notice of proposed rulemaking. Thus, regulatory negotiation is not an alternative to notice and comment rulemaking, but rather is another step in that process. In Recommendation 82-4,38 the Conference urged Congress 39 to expressly authorize agency use of regulatory negotiation procedure, but only only on an experimental basis. The recommendation recognizes that regulatory negotiation will not be appropriate for many, or even most, rulemakings, and the factors bearing on the decision to use the procedure are set out in the recommendation. 40 Although Congress has not yet enacted legislation, a few agencies have decided to try regulatory negotiation in selected rulemakings. 41 4. Federal Advisory Committee Act requirements. Agency interaction with private standard-setting organizations and the use of regulatory negotiation are complicated by the Federal Advisory Committee Act (FACA)42 which applies whenever an Regulation, 1 C.F.R. S 305.78-4 (1983). 38/ ACUS Recommendation 82-4, Procedures for Negotiating Proposed Regulations, 1 C.F.R. S 305.82-4 (1983). The recommendation is based on Harter, Negotiating Regulations: A Cure for Malaise, 71 Geo. L.J. 1 (1982). 39/ Id., 12 (legislation should contain a sunset provision). 40/ Id., ¶ 4(a)-(g). 41/ See EPA, Notice of Regulatory Negotiation Project and Invitation for Suggestions of Candidates, 48 Fed. Reg. 7,494 (Feb. 22, 1983); FAA, Notice of Intent to Form Advisory Committee for Regulatory Negotiation of Flight Time, Duty Time, and Rest Requirements for Flight Crew Members, 48 Fed. Reg. 21,339 (May 12, 1983). (Continued) |