In administrative law in the United States, rulemaking is the process that executive and independent agencies use to create, or promulgate, regulations. In general, legislatures first set broad policy mandates by passing statutes, then agencies create more detailed regulations through rulemaking.
By bringing detailed scientific and other types of expertise to bear on policy, the rulemaking process has been the means by which some of the most far-reaching government regulations of the 20th century have been created. For example, science-based regulations are critical to modern programs for environmental protection, food safety, and workplace safety. However, the growth in regulations has fueled criticism that the rulemaking process reduces the transparency and accountability of democratic government.
Introduction Legislatures rely on rulemaking to add more detailed scientific, economic, or industry expertise to a policy—fleshing out the broader mandates of authorizing legislation. For example, typically a legislature would pass a law mandating the establishment of safe drinking water standards, and then assign an agency to develop the list of contaminants and safe levels through rulemaking.
The rise of the rulemaking process itself is a matter of political controversy. Many find that obscure and complex rulemaking tends to undercut the democratic ideal of a government that is closely watched by and accountable to its citizens.
Purposes Although executive agencies are usually charged with executing, not promulgating a regulatory scheme, the breadth and depth of regulation today renders it difficult, if not impossible, for legislatures to specify the details of modern regulatory schemes. As a result, the specification of these details are mostly delegated to agencies for rulemaking.
Common purposes of rulemaking include: Adding scientific expertise. For example, in the U.S., the Federal Food, Drug, and Cosmetic Act outlaws the sale of adulterated or impure drugs. The act requires that the Department of Health and Human Services promulgate regulations establishing which laboratory tests to use to test the purity of each drug. Adding implementation detail. Legislation on automobile fuel efficiency, for example, often delegates the development of the actual engine tests used to calculate 'city mileage' and 'highway mileage'. Adding industry expertise. The U.S. Clean Air Act and Clean Water Act require the United States Environmental Protection Agency to determine the appropriate emissions control technologies on an industry-by-industry basis. Adding flexibility. More detailed regulations allow for more nuanced approaches to various conditions than a single legislative standard could. Moreover, regulations tend to be more easily changed as new data or technologies emerge. Finding compromise. In some cases, a divided legislature can reach an agreement on a compromise legislative standard, while each side holds out hope that the implementing regulations will be more favorable to its cause.
Process
Rulemaking processes are generally designed to ensure that The public is informed of proposed rules before they take effect; The public can comment on the proposed rules and provide additional data to the agency; The public can access the rulemaking record and analyze the data and analysis behind a proposed rule; The agency analyzes and responds to the public's comments; The agency creates a permanent record of its analysis and the process; The agency's actions can be reviewed by a judge or others to ensure the correct process was followed.
The primary administrative law statutes and other laws that govern agency rule making include:David E. Boundy, The PTAB is Not an Article III Court, Part 1: A Primer on Federal Agency Rulemaking, American Bar Ass’n, Landslide, vol. 10 no. 2 pp. 9–13 (Nov-Dec 2017) here or here The Administrative Procedure Act, 5 U.S.C. §§ 552 and 553 The Housekeeping Act, 5 U.S.C. § 301, which gives heads of agencies authority to issue rules for agency employees The Regulatory Flexibility Act, 5 U.S.C. §§ 601 et seq., which requires agencies to consider the needs of small entities in rule making The Paperwork Reduction Act, 44 U.S.C. §§ 3501 et seq., which limits the power of an agency to collect information from the public The Congressional Review Act, 5 U.S.C. §§ 801–808, which gives Congress the authority to review and veto any agency regulation The Independent Offices Appropriations Act of 1952, 31 U.S.C. §§ 9701, which limits the power of agencies to set user fees Executive Order 12866, which requires agencies to use cost-benefit balancing in all regulatory actions
For example, a typical U.S. federal rulemaking would contain these steps: Legislation. The U.S. Congress passes a law, containing an organic statute that creates a new administrative agency, and that outlines general goals the agency is to pursue through its rulemaking. Similarly, Congress may prescribe such goals and rulemaking duties to a pre-existing agency. When the agency begins to develop a rule, the agency must file with OMB to put the rule on the "regulatory agenda".5 U.S.C. § 602(a); Executive Order 12,866 (as amended), § 4(b). For an example, see Department of Commerce, Spring 2009 Semiannual Agenda of Regulations, 74 Fed. Reg. 21887–914 (May 11, 2009). In the process of developing a rule, before publication in a Notice of Proposed Rulemaking, the agency must “consult with members of the public”The requirement to “consult with members of the public” before a Notice of Proposed Rule Making (NPRM) is not literally in the text of the statute, but arises out of the interdependencies between required steps, and the practical reality that most agencies have no internal sources of objective compliance cost information, and can only obtain objective cost information by conferring with the public. For information collection requests contained in a proposed rule, 44 U.S.C. § 3507(d)(1)(A), 5 C.F.R. § 1320.5(a)(3) and § 1320.11(b) require that an agency submit an ICR to OMB “as soon as practicable, but no later than the date of publication of a notice of proposed rulemaking in the Federal Register.” An agency also is required, by 44 U.S.C. § 3507(a)(1)(D)(ii)(V) and 5 C.F.R. § 1320.5(a)(iv), to publish a notice in the Federal Register "setting forth … an estimate of the burden that shall result from the collection of information". § 3506(c)(1)(A)(iv) and § 1320.8(a)(4) require that any burden estimate submitted to the OMB Director, including those under § 3507(d)(1)(A), be "objectively supported". For the types of burden in most agency rule makings—i.e., new requirements for content or form of papers—the only practical source of "objective support" for burden estimates is "conferring" with attorneys who do similar work. This set of critical path events requires consultation with the public sufficiently before the Notice of Proposed Rule Making to permit “objectively supported estimates” to be included with and supported in the NPRM and in submissions to OMB under the Paperwork Reduction Act. to evaluate the following:44 U.S.C. § 3506(c)(2) and 5 C.F.R. § 1320.8(d)(1). (i) whether the proposed collection of information is necessary for the proper performance of the functions of the agency; (ii) the accuracy of the agency's estimate of the burden; (iii) how to enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond.
Advance Notice of Proposed Rulemaking. This optional step entails publishing the agency's initial analysis of the subject matter, often asking for early public input on key issues. Any data or communications regarding the upcoming rule would be made available to the public for review. Occasionally, a board of potentially affected parties is comprised to do give-and-take bargaining over rulemaking subject-matter which would otherwise result in deadlocked opposition by an interested party. This is commonly called "negotiated rulemaking", and results in more custom-tailored proposed rule. An ANPRM can be a useful opportunity for the agency to collect some of the information and feedback it needs for later steps. If the rule is “economically significant” under Executive Order 12,866,Executive Order 12,866 § 3(f) defines “significant regulatory action” as any rule making that is likely to result in a rule that may: (1)Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in this Executive order. then the agency must prepare a Regulatory Impact Analysis under OMB Circular A-4 before the agency publishes a Notice of Proposed Rulemaking.Executive Order 12,866 is available at https://georgewbush-whitehouse.archives.gov/omb/inforeg/eo12866/index_eo12866.html. Circular A-4 is at . Any ruleWhether that rule is published in the Code of Federal Regulations, a guidance document, or some other document. that imposes or modifies any “information collection” burden on the public must be submitted to the Director of OMB, with “objectively supported” estimates, no later than the time of a Notice of Proposed Rulemaking.Reading 44 U.S.C. § 3507(d)(1) and § 3506(c)(2)(A) together. As part of this submission, the agency must certify or demonstrate (depending on the setting), and provide a record in support of the certification,44 U.S.C. § 3506(c)(3) and 5 C.F.R. § 1320.9. that: (a) the information to be collected “is necessary for the proper performance of the functions of the agency”;44 U.S.C. § 3506(c)(3)(A) and 5 C.F.R. § 1320.5(d)(1)(i) (“ To obtain OMB approval of a collection of information, an agency shall demonstrate that it has taken every reasonable step to ensure that the proposed collection of information: (i) Is the least burdensome necessary for the proper performance of the agency’s functions…”). (b) the agency is not seeking “unnecessarily duplicative” collection of “information otherwise reasonably accessible to the agency”;44 U.S.C. § 3506(c)(3)(B) and 5 C.F.R. § 1320.5(d)(1)(ii). (c) the agency “has taken every reasonable step to ensure that the proposed collection of information … is the least burdensome necessary”;44 U.S.C. § 3506(c)(2)(A)(iv) and 5 C.F.R. § 1320.5(d)(1)(i). and (d) the regulations are “written using plain, coherent, and unambiguous terminology.”44 U.S.C. § 3506(c)(3)(D) and 5 C.F.R. § 1320.9(d). Proposed Rule. In this step, the agency publishes the actual proposed regulatory language in the Federal Register; in which a discussion of the justification and analysis behind the rule is printed, as well as the agency's response to any public comment on the advance notice. Public comment. Once a proposed rule is published in the Federal Register, a public comment period begins, allowing the public to submit written comments to the agency. Most agencies are required to respond to every issue raised in the comments. Depending on the complexity of the rule, comment periods may last for 30 to even 180 days.