Editing Rulemaking (section)

==Process==
[[File:Rulemaking Approach-1 (51254291264).png|thumb|upright=2|A partial diagram of the rulemaking process as described by the US [[Nuclear Regulatory Commission]] in 2021]]
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:<ref>[[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) [https://www.americanbar.org/content/dam/aba/publications/landslide/2017-nov-dec/ptab-not-article-iii-court.authcheckdam.pdf here] or [https://ssrn.com/abstract=3258044 here]</ref>
* The [[Administrative Procedure Act (United States)|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 [[United States Congress|U.S. Congress]] passes a law, containing an [[Organic statute (United States)|organic statute]] that creates a new [[government agency|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]]".<ref>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).</ref>
* In the process of developing a rule, before publication in a Notice of Proposed Rulemaking, the agency must “consult with members of the public”<ref>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.</ref> to evaluate the following:<ref>44 U.S.C. § 3506(c)(2) and 5 C.F.R. § 1320.8(d)(1).</ref>
:(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.<ref name=APA>{{cite web
  | title =See ''Administrative Procedure Act'', 5 U.S.C. 561, ''et. seq.''
  | url=http://www.access.gpo.gov/uscode/title5/parti_chapter5_subchapteriii_.html 
  | access-date = 2008-06-05 |archive-url = https://web.archive.org/web/20080410191407/http://www.access.gpo.gov/uscode/title5/parti_chapter5_subchapteriii_.html <!-- Bot retrieved archive --> |archive-date = 2008-04-10}}</ref> This is commonly called "[[negotiated rulemaking]]",<ref name=APA/> 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,<ref>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.</ref> then the agency must prepare a Regulatory Impact Analysis under OMB Circular A-4 before the agency publishes a Notice of Proposed Rulemaking.<ref>Executive Order 12,866 is available at https://georgewbush-whitehouse.archives.gov/omb/inforeg/eo12866/index_eo12866.html. Circular A-4 is at [https://web.archive.org/web/20031224093625/http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf].</ref>
* Any rule<ref>Whether that rule is published in the Code of Federal Regulations, a guidance document, or some other document.</ref> 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.<ref>Reading 44 U.S.C. § 3507(d)(1) and § 3506(c)(2)(A) together.</ref> As part of this submission, the agency must certify or demonstrate (depending on the setting), and provide a record in support of the certification,<ref>44 U.S.C. § 3506(c)(3) and 5 C.F.R. § 1320.9.</ref> that:
(a) the information to be collected “is necessary for the proper performance of the functions of the agency”;<ref>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…”).</ref>
(b) the agency is not seeking “unnecessarily duplicative” collection of “information otherwise reasonably accessible to the agency”;<ref>44 U.S.C. § 3506(c)(3)(B) and 5 C.F.R. § 1320.5(d)(1)(ii).</ref>
(c) the agency “has taken every reasonable step to ensure that the proposed collection of information … is the least burdensome necessary”;<ref>44 U.S.C. § 3506(c)(2)(A)(iv) and 5 C.F.R. § 1320.5(d)(1)(i).</ref> and
(d) the regulations are “written using plain, coherent, and unambiguous terminology.”<ref>44 U.S.C. § 3506(c)(3)(D) and 5 C.F.R. § 1320.9(d).</ref>
* '''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.
* '''Final Rule.''' Usually, the proposed rule becomes the final rule with some minor modifications.  In this step, the agency publishes a full response to issues raised by public comments and an updated analysis and justification for the rule, including an analysis of any new data submitted by the public.  In some cases, the agency may publish a second draft proposed rule, especially if the new draft is so different from the proposed rule that it raises new issues that have not been submitted to public comment.  This again appears in the [[Federal Register]], and if no further steps are taken by the public or interested parties, it is codified into the [[Code of Federal Regulations]].
* '''[[Judicial review]]'''.  In some cases, members of the public or regulated parties file a lawsuit alleging that the rulemaking is improper.  While courts generally offer significant deference to the agency's technical expertise, they do review closely whether the regulation exceeds the rulemaking authority granted by the authorizing legislation and whether the agency properly followed the process for public notice and comment.
* '''Effective date'''.  Except in extraordinary circumstances, the rule does not become effective for some time after its initial publication to allow regulated parties to come into compliance.  Some rules provide several years for compliance.
* '''"Hybrid" rulemaking'''. Not a legal term of art, but describes the kind of rulemaking performed by agencies that is somewhere between formal (with a hearing and record) and informal (with the notice and comment procedures described above).  Hybrid rulemaking generally subsumes procedural aspects reserved for adjudication, such as a formal hearing in which interested parties are sworn and subject to cross-examination.  The statutory construction of the [[Administrative Procedure Act (United States)|Administrative Procedure Act]], as well as the [[United States Supreme Court|Supreme Court's]] ruling in ''[[Vermont Yankee Nuclear Power Corp. v. Natural Resources Defense Council, Inc.]]'',<ref>''See''[http://biotech.law.lsu.edu/cases/adlaw/vermont-yankee.htm ''Vermont Yankee Nuclear Power Corp. v. Natural Resources Defense Council, Inc'',  435 U.S. 519 (1978)] from [http://biotech.law.lsu.edu/index.htm Louisiana State University – Medical & Public Health Law site]</ref> make hybrid-rulemaking proper only when specifically provided for by the [[United States Congress|U.S. Congress]].

In the United States when an agency publishes a final rule generally the rule is effective no less than thirty days after the date of publication in the Federal Register.  If the agency wants to make the rule effective sooner, it must cite "good cause" (persuasive reasons) as to why this is in the public interest.

Significant rules (defined by Executive Order 12866) and major rules (defined by the Small Business Regulatory Enforcement Fairness Act ) are required to have a 60-day delayed effective date.<ref>{{cite web|title=A Guide to the Rulemaking Process|url=https://www.federalregister.gov/uploads/2011/01/the_rulemaking_process.pdf|website=federalregister.gov|publisher=Office of the Federal Register|access-date=19 November 2016}}</ref>