agency seeks advice and recommendations from outside groups. FACA includes requirements for (1) the chartering of advisory committees, (2) committee membership, including conditions on the participation of government employees, and (3) open meetings with notice and limited participation rights given to members of the public. Though laudable in purpose, these specific requirements can interfere with agency interaction with private groups in the pre-NPRM stage of rulemaking. Consequently, the Conference has recommended that Congress amend FACA to exclude standard-setting organizations from the definition of "advisory committee."" The Conference's recommendation on regulatory negotiation asks Congress to provide in legislation "substantial flexibility for agencies to adapt negotiation techniques to the circumstances of individual proceedings... free of the restrictions of the Federal Advisory Committee Act . 43 ... "44 The Federal Advisory Committee Act not only interferes with the relatively structured relationships with private groups discussed above, it also chills informal agency consultation with outside groups during the pre-NPRM stage of rulemaking. The Administrative Conference adopted recommendations in 1980 regarding the coverage of FACA, including the following conclusion and recommendation: Uncertainty as to the applicability of FACA to 45 42/ 5 U.S.C., App. 1 (1976). 43/ ACUS Recommendation 78-4, supra note 37, at ¶ 1(e). The Conference also interprets the Act to apply only to committees that are either established by government action or "utilized" by the government "through institutional arrangements which amount to the adoption of the group as a preferred source of ,46 advice." The Conference's views recently were adopted by the General Services Administration in interim rules published under 47 FACA. Still, there remains some uncertainty about the coverage of FACA. 48 D. Data Collection Considerations. The APA does not expressly require agencies to assemble factual support for proposed, or even final, rules. Of course, agencies ordinarily will not proceed to rulemaking without assembling some body of information to justify their action. Additionally, regulatory analysis of some kind frequently is required by the Regulatory Flexibility Act, Executive Order 12291, or statutes under which agencies operate. Therefore, as a practical matter, all but the most innocuous rules will be preceded by some investigation and data collection. The kinds of data needed in a pre-rulemaking investigation may be very different from those needed in adjudication. The "polycentric" nature of many rulemaking problems and the wide Recommendation 45/ A CUS 80-3, Interpretation and Implementation of the Federal Advisory Committee Act, 1 C.F.R. S 305.80-3, 2(a) (1983). 46/ Id., 2(b). 47/ GSA, Federal Advisory Committee Management: Interim Rule, 48 Fed. Reg. 19323-31 (Apr. 28, 1983). The Act originally charged the Office of Management and Budget with the task of issuing guidelines. This authority was transferred to GSA by Reorganization Plan No. 1 of 1977 and Exec. Order No. 12,024, § 5, 3 C.F.R. 158 (1977). 48/ This uncertainty stems from the relatively few court cases that have interpreted FACA's imprecise definition of "advisory committee." See generally Cardozo, The Federal Advisory Committee Act in Operation, 33 Ad. L. Rev. 1 (1981); Hamilton, supra note 34, at 1475-77. See also National Anti-Hunger Coalition v. Exec. Comm. of the President's Private Sector Survey on Cost Control, 557 F. Supp. 524 (D.D.C. 1983). For an excellent analysis of the legislative history of FACA, see Marblestone, The Coverage of the Federal Advisory Committee Act, 35 Fed. B.J. 119 (1976). range of relevant data make planning data collection a critical function in rulemaking. 1. Determining what information is required. The rulemaking staff first must ask: "What information is needed to make and support a final rulemaking decision?" That is, what information will the agency decisionmaker need to (1) determine the need for any regulation, and (2) select an appropriate regulatory response to the problem. The information needed to enable the decisionmaker to judge the need for and merits of possible regulatory actions may be different, and more extensive, than that needed to persuade a reviewing court of the final rule's validity. In determining which data are required to meet legal requirements, the rulemaking staff will be guided by the agency's enabling statutes. In recent years, Congress frequently has specified findings or conclusions which agencies must make prior to imposing authorized remedies ar sanctions. Reviewing courts' interpretations of the standard of review applicable to agency rules also may provide guidance on the data needed to support a rule on judicial review. Substantial additional da ta collection and analysis requirements recently have been imposed for rules having significant or major impacts by the Regulatory Flexibility Act and 49 Executive Order 12291. As discussed in Chapter Two, the Regulatory Flexibility Act requires analysis of the potential economic impact of rules on small businesses and other small entities. Executive Order 12291 requires agencies, to the extent permitted by law, to base decisions on "adequate information concerning the need for and consequences of proposed government action," and to refrain from action "unless the potential benefits to society from the regulation outweigh the potential costs to society."50 The order also states that prior to approving any final "major" rule, the agency must determine that the factual conclusions upon which the rule is based have "substantial support 49/ See discussion beginning at p. 47. 50/ Exec. Order No. 12,291, S 2(a)-(b). See Chapter Two at pp. 5155 for a more complete discussion of the order's provisions. in the rulemaking record, taken as a whole."51 Especially in rulemakings subject to these additional analysis requirements, the rulemaking staff may find it useful to make the following distinction in data needed in rulemaking: (1) a rulemaking record often will contain data describing or documenting a problem that exists, and (2) the record also will contain factual data the decisionmaker may need to evaluate the merits of possible alternative rule provisions, assuming, of course, that the agency has discretion in fashioning remedies to solve or alleviate the problem. For example, an agency may be authorized to regulate practices or substances which are harmful. Data will be necessary to demonstrate the potential or actual injury caused by the practice or substance. However, after establishing potential or actual harm, the agency decisionmaker will be faced with the often more difficult problem of deciding the appropriate remedy for the injury. Will, for example, disclosure of information to consumers or workers prevent the injury? What is the effectiveness and cost of various disclosure methods? What level of exposure to a substance is acceptable or acceptable or economically feasible? Data relevant to such issues may be obtainable and necessary to sound decisionmaking. In summary, the trend in decisions by Congress, reviewing courts, and the Executive Branch in the last decade to require record support for final rules should cause the prudent rulemaking staff to view the traditional "presumption of validity" of rules cautiously, even where the legal requirements for a particular rulemaking do not seem to dictate rigorous data collection. If information is obtainable and likely to be viewed as significant by the agency decisionmaker or a reviewing court, the rulemaking staff should consider including such information in the file. 2. Locating sources of the information. Data regarding the need for and consequences of a rule may be difficult and expensive for agencies to produce "in-house." Careful attention should be given to existing sources of data bearing on the problem. Again, depending on the nature of the rule, these might 51/ Id., S 4(b). include: other government agencies (including state and local agencies); outside experts (e.g., the academic community, private standard-setting organizations); the potentially regulated or "target" class; related industries; other interested persons (e.g., non-profit interest groups or local civic groups), and the general public. 3. Deciding which data collection techniques to use. The rulemaking staff should begin by reviewing the investigative techniques that are either authorized or mandated by law for the agency. For example, some statutes require publication of an advance notice of proposed rulemaking and others require referral to an advisory committee in the pre-NPRM stage. Agencies required to do regulatory analysis involving the weighing costs and benefits may find that they must rely on industry to voluntarily supply cost information, and companies often are reluctant to disclose such proprietary information. Even if agencies have authority to compel production of information, it may be prohibitively costly to pursue this method of data collection. Within the legal constraints on choice of data collection techniques, the rulemaking staff should consider the advantages of 53 public participation at some point in the pre-NPRM process. Exposure of the staff's investigative results and preferred regulatory approach to public criticism before publication of the NPRM has the advantage of permitting changes in the proposal without adherence to any procedural requirements. Early consultation with potentially interested persons also demonstrates an open mind by the agency, particularly when changes are made in response to criticisms. Other factors the staff should consider before "going public" in the pre-NPRM stage are (1) the degree of agency reliance on external sources of information; (2) the likelihood that interested persons will voluntarily provide the 52/ See discussion of this problem in U.S. Regulatory Council, Ten Agency Survey, supra note 17 at 21-22. 53/ Early public participation was a key element of President Carter's Executive Order No. 12,044. See Chapter One, text accompanying nn. 32-34. |