Bush Administration, OMB has been concerned about the proper development and use of agency guidance documents. In its 2002 draft annual Report to Congress on the Costs andBenefits of Regulations, OMB discussed this issue and solicited public commentsregarding problematic guidance practices and specific examples of guidance documentsin need of reform.
OMB has been particularly concerned that agency guidance practicesshould be more transparent, consistent and accountable. Suchconcerns also have beenraised by other authorities, including Congress and the courts.
In its 2002 Report to Congress, OMB recognized the enormous value of agencyguidance documents in general. Well-designed guidance documents serve manyimportant or even critical functions in regulatory programs.
Agencies may providehelpful guidance to interpret existing law through an interpretive rule or to clarify howthey tentatively will treat or enforce a governing legal norm through a policy statement.Guidance documents, used properly, can channel the discretion of agency employees,increase efficiency, and enhance fairness by providing the public clear notice of the linebetween permissible and impermissible conduct while ensuring equal treatment of similarly situated parties.
1
U.S. Office of Management and Budget, Draft Report to Congress on the Costs and Benefits of FederalRegulations, 67 FR 15,014, 15,034-35 (March 28, 2002).
2
See, e.g., Food and Drug Administration Modernization Act of 1997, 21 U.S.C. § 371(h) (establishingFDA good guidance practices as law); “Food and Drug Administration Modernization and AccountabilityAct of 1997,” S. Rep. 105-43, at 26 (1997) (raising concerns about public knowledge of, and access to,FDA guidance documents, lack of a systematic process for adoption of guidance documents and forallowing public input, and inconsistency in the use of guidance documents); House Committee onGovernment Reform,
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Non-Binding Legal Effect of Agency Guidance Documents,
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H. Rep. 106-1009(106
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Cong., 2d Sess. 2000) (criticizing “back-door” regulation); the Congressional Accountability forRegulatory Information Act, H.R. 3521, 106
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Cong., § 4 (2000) (proposing to require agencies to notify thepublic of the non-binding effect of guidance documents) ; Gen. Elec. Co. v. EPA, 290 F.3d 377 (D.C. Cir.2002) (striking down PCB risk assessment guidance as legislative rule requiring notice and comment);Appalachian Power Co. v. EPA, 208 F.3d 1015 (D.C. Cir. 2000) (striking down emissions monitoringguidance as legislative rule requiring notice and comment); Chamber of Commerce v. Dep’t of Labor, 174F.3d 206 (D.C. Cir. 1999) (striking down OSHA Directive as legislative rule requiring notice andcomment); Administrative Conference of the United States, Rec. 92-2, 1 C.F.R. 305.92-2 (1992) (agenciesshould afford the public a fair opportunity to challenge the legality or wisdom of policy statements and tosuggest alternative choices); American Bar Association, Annual Report Including Proceedings of the Fifty-Eighth Annual Meeting, August 10-11, 1993, Vol. 118, No. 2, at 57 (“the American Bar Associationrecommends that: Before an agency adopts a nonlegislative rule that is likely to have a significant impacton the public, the agency provide an opportunity for members of the public to comment on the proposedrule and to recommend alternative policies or interpretations, provided that it is practical to do so; whennonlegislative rules are adopted without prior public participation, immediately following adoption, theagency afford the public an opportunity for post-adoption comment and give notice of this opportunity.”); 3American Bar Association, “Recommendation on Federal Agency Web Pages” (August 2001) (agenciesshould maximize the availability and searchability of existing law and policy on their websites and includetheir governing statutes, rules and regulations, and all important policies, interpretations, and other likematters on which members of the public are likely to request).
3
See U.S. Office of Management and Budget, Stimulating Smarter Regulation: 2002 Report to Congresson the Costs and Benefits of Regulations and Unfunded Mandates on State, Local and Tribal Entities, 72-74 (2002) (hereinafter “2002 Report to Congress”).2
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