Adjudication is the term usually applied to the action of an administrative agency when that agency acts like a court. In an adjudication, an agency applies statutory requirements or general regulations or policies to a specific party or a small number of parties in a given situation. In the agency adjudication process, the functions of judge and jury are combined in a single entity—either an administrative law judge, a hearing officer, or some type of board—which both conducts a hearing and makes a decision. This decision is usually called an “initial decision.” An “initial decision” may become a “final decision” automatically unless a party in the case appeals the decision to the agency head or designated agency official or appeals board, according to the agency’s own procedures. The agency, on appeal, may affirm, reverse, or remand the initial decision, but must explain any departure from the initial decision. The agency’s own adjudicative procedures will be spelled out in procedural rules, which will usually be found in the Code of Federal Regulations.

The final agency decision, sometimes called an “opinion,” is usually in writing and will set out the reasons for that decision. It must be made available to the parties and indexed. A final decision in an adjudication can serve as a precedent for future cases but is normally binding only on the named parties. Occasionally, in making such a decision, an agency may announce that the reasoning of that decision will only be applied in future cases. Some agencies, most notably the National Labor Relations Board, make most of their policy through case-by-case adjudication rather than through rulemaking.

The Administrative Conference of the United States (ACUS) is an independent Federal agency dedicated to improving the administrative process through consensus-driven applied research, and providing nonpartisan expert advice and recommendations to improve of Federal agency procedures. Its membership is composed of innovative Federal officials and experts from both the private sector and academia with diverse views and backgrounds. Past ACUS recommendations and descriptions of current activities are available at www.acus.gov.

Administrative Law Judges (ALJs) are Federal agency employees who have been appointed under provisions of the Administrative Procedure Act to preside over formal APA hearings. They are all attorneys. Over 30 Federal agencies employ over 1600 ALJs, although 85% are employed by the Social Security Administration. ALJs make initial or recommended decisions that are subject to appeal to the agency head or the agency head’s designee.

Under the APA, ALJs are appointed by agencies after a special qualification procedure organized by the Office of Personnel Management. The APA also guarantees them special protections designed to protect their decisional independence. They may not be assigned duties that are inconsistent with their position as judges. They may not be supervised by agency investigators or prosecutors. They are exempted from performance ratings; their pay is set by statute and based on seniority; and they may not be disciplined or dismissed unless good cause is shown before the Merit Systems Protection Board.

ALJs are to be distinguished from the many “administrative judges,” “hearing officers,” and other non-ALJ adjudicators used by agencies to preside over non-APA cases.

The Administrative Procedure Act (APA) (1946) (recodified mostly in 5 U.S.C. §§ 551-559, 701-706) is the basic law that tells Federal agencies how they must operate when they issue rules or adjudicate cases. The law spells out the basic “rules of the game.” Thus, the minimum steps that an agency must follow when it issues most rules are spelled out in the APA—publish a proposal in the Federal Register, invite and consider comment, and issue a final rule at least 30 days before its effective date.

Besides the procedural requirements established in the APA, an agency may be required to follow additional procedural requirements contained in other statutes such as the Regulatory Flexibility Act. In addition, a law that establishes an agency or a law that assigns an agency new functions may contain procedural requirements in addition to those spelled out in the APA. Also, an agency may have adopted additional procedural rules beyond those required by the APA or the agency’s own statute. These rules will usually be found in the Code of Federal Regulations, but sometimes are written only in an agency’s internal documents. These additional rules are binding on an agency if it has announced that it will follow them.

Most states now have enacted state APAs that prescribe procedures for state administrative agencies.

An Advance Notice of Proposed Rulemaking (ANPRM) is a document that an agency may choose to issue before it is ready to issue a Notice of Proposed Rulemaking (NPRM). It may also be called a “notice of inquiry” or simply a “request for comments.”  The ANPRM is used by an agency as a vehicle for obtaining public participation in the formulation of a regulatory change typically before the agency has done significant research or investigation on its own. Thus, one of the primary uses of an ANPRM is to involve the interested public in a potential regulatory action at an early stage, before the agency has arrived at even a tentative decision on a particular regulatory change. In some cases, the agency may issue an ANPRM to test public reaction to a proposal.

The APA does not mention the ANPRM as an official part of the rulemaking process. Nor is an agency required to issue an ANPRM unless a specific statute or the agency’s own rules require it to do so. Also, an agency cannot use the ANPRM’s notice-and-comment period as the only basis for issuing a final rule. If an agency chooses to use an ANPRM, it still must issue an NPRM before issuing a final rule on that subject.

The semi-annual Unified Regulatory Agenda in which agencies are required to participate can be viewed as an advance notice of all significant rulemaking actions being considered by each Federal agency.

For the purpose of the Administrative Procedure Act (APA) and most other procedural statutes, “agency” is defined to include every Federal Government entity in the executive branch, whether or not it is within or subject to review by another agency. It thus includes cabinet departments; administrative agencies that are housed within departments, such as the Occupational Safety and Health Administration (OSHA) within the Department of Labor; “independent regulatory agencies,” such as the National Labor Relations Board; and other agencies that are independent of a department, but not “independent regulatory agencies,” such as the Environmental Protection Agency, General Services Administration, and National Aeronautics and Space Administration.

The arbitrary-or-capricious test is a short-hand term for the scope-of-judicial-review provision in section 706(2)(A) of the APA directing reviewing courts to invalidate agency actions found to be “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”

This test applies to all agency action, but perhaps most significantly to the review of the factual basis for agency rulemaking. In this context, reviewing courts have overturned agency rules if the underlying policy judgments, reasoning, or asserted factual premises of the action are so unreasonable as to be arbitrary.

A different test, the “substantial evidence” test, is required by the APA to be used in reviewing the factual support for decisions made after formal hearings (i.e., formal adjudications and formal rulemakings). But court interpretations of these two tests have indicated that there is not much difference between their respective applications.

In the case of Auer v. Robbins, 519 U.S. 452 (1997), the Supreme Court deferred to a Department of Labor interpretation of its own existing regulation even though it was provided for the first time in a brief. This “Auer deference,” provided to agency interpretations of their own regulations, is seemingly equal to the “Chevron deference” courts give to agency interpretations of ambiguous statutes they administer. However, the Court has declined to apply it to agency interpretations of regulations that simply “parrot” the statute, as well as to changed interpretations applied in an enforcement proceeding to a party that had fairly relied on an earlier interpretation.

Recent Supreme Court decisions have been quite critical of Auer deference. See Talk America Inc. v. Michigan Bell Telephone Co., 564 U.S. 50 (2011), Christopher v. SmithKline Beecham Corp., 567 U.S. 142 (2012), and Perez, et al. v. Mortgage Bankers Association, et al., 575 U.S. 92 (2015). In Kisor v. Wilkie, 588 U.S. ___ (2019), the Supreme Court rejected the request to overrule Auer but imposed guardrails on application of Auer Deference.

The 1984 Supreme Court decision in Chevron U.S.A., Inc. v. NRDC, 467 U.S. 837 (1984), set forth rules for judicial review of agency interpretations of statutes they administer which applied for four decades until the Court overturned Chevron in 2024 and is one of the most cited administrative law decisions of all time. Obviously, this issue can arise frequently when agency rules are challenged in court because such rules must be grounded in the agency’s statutory authority.

The Chevron decision established a two-step test to be used by courts in such situations. Under “step one” of the Chevron doctrine, the court determined whether Congress had directly spoken to the precise question at issue. If it had, that was the “end of the matter.” If, however, the statute was silent or ambiguous on the issue, the court moved to “step two.” The question then was whether the agency’s answer was based on a “permissible” construction of the statute. If so, then the court deferred.

The Chevron case itself involved an interpretation made in an EPA regulation issued after a notice-and-comment procedure. Later cases made clear that the Chevron test normally did not apply to agency interpretations made in less formal settings, such as policy statements or rulings made without notice and comment. Such interpretations are given a lower level of deference by the courts. (See Skidmore Test).

Loper Bright Enterprises v. Raimondo, 603 U.S. ___ (2024), overruled the Chevron doctrine, holding that Federal courts have the authority to determine whether an agency has made an appropriate interpretation of an ambiguous statute.

The Code of Federal Regulations (CFR) contains the rules and regulations of Federal agencies in a codified format, similar to the U.S. Code, which codifies laws enacted by Congress. The CFR is divided into 50 titles or subject areas, each broken down into chapters, subchapters, parts, and sections. Each agency’s regulations are found in one or more chapters of the CFR, depending on the function and variety of that agency’s responsibilities. The Nuclear Regulatory Commission’s regulations, for example, appear in Chapter 1 of Title 10.

The paper CFR comprises approximately 200 volumes and totals approximately 140,000 pages. Each title of the CFR is revised annually, at which time all additions and amendments to that title which have appeared in the Federal Register over the past year are inserted into their proper places. But an online, up-to-date e-CFR (non-official version of the CFR) is available at https://www.ecfr.gov. 

In 1996, Congress enacted a new procedure under which all Federal agencies are required to submit each “rule” to both Houses of Congress and to the Government Accountability Office before it can take effect. Because “rule” is broadly defined, many documents are sent to Congress by the agencies every day.

Under this Congressional review of rules procedure (see 5 U.S.C. §§ 801-808), a “major” rule’s effective date is automatically stayed for 60 days while Congress reviews it. The Act also contains a procedure for expedited review by Congress when a Member introduces a “resolution of disapproval.” If such a resolution is passed by both Houses of Congress and is signed by the President (or enacted over his veto), then the rule becomes null and void. Nor may a similar rule be issued by the agency unless authorized by a subsequent law.

The process requires both Congressional and Presidential approval (or a veto override). It was used once during the Bush II Administration to “veto” OSHA’s “ergonomics” rule, which the Clinton Administration issued in late 2000. It was used at least 16 times during the Trump Administration and has been used at least 3 times during the Biden Administration.

Cost-benefit analysis (sometimes called benefit-cost analysis) is a mode of analysis that has become increasingly more important in rulemaking, driven primarily by requirements in Presidential executive orders. President Carter’s E.O. 12044 required agencies to undertake a “regulatory analysis” (including an analysis of the economic consequences) of the proposed rule for major rules with an economic impact of over $100 million. President Reagan’s E.O. 12291 substituted the term “regulatory impact analysis” and was more specific in requiring an analysis of costs and benefits. President Clinton’s E.O. 12866, still operative today, requires an “assessment” of costs and benefits for major rules. These analyses form one of the main bases for OIRA review. (See Presidential Review of Rules.) OMB has issued guidance to agencies on the preparation of cost-benefit analyses in OMB Circular A-4.

A direct final rule is a rule published first as a final rule with an accompanying statement indicating that the rule will take effect in X days unless someone submits a significant adverse or negative comment, or a notice of intent to submit such a comment, within a stated number of days. If no such comment or notice of intent is received, the rule automatically takes effect, but if one is received, and the agency wishes to go forward, the agency must republish the document as a proposed rule and proceed with normal notice-and-comment rulemaking. Direct final rulemaking was developed by agencies as a streamlining technique to be used when they are confident that a rule will be non-controversial.

A docket is simply a file. In most agencies, a docket is opened and given a specific number or letter identification whenever a rulemaking or adjudicatory action begins. The docket usually includes all relevant public information about that rulemaking or adjudication if the agency intends to use that information in reaching a decision. For example, all public comments received on a proposed rule will be in the docket on that rulemaking. Each agency has its own way of identifying dockets. There is no consistency among agencies, so one cannot assume that one agency's numbering system is applicable to another agency. When writing to an agency about a proceeding, it is very important to use the appropriate docket number, if there is one, so that the information submitted will reach the correct destination. The docket number usually appears near the beginning of a rulemaking document when it is published in the Federal Register.

Many agencies historically maintained a central docket room where all of the agency’s public rulemaking files and related material were made available. However, most agencies have established electronic docket systems so that it is possible to research docket contents electronically through the agency’s website. See also Regulations.gov.

DocketScope is a comments analysis software platform that interfaces directly with Regulations.gov. DocketScope facilitates compiling, organizing, and analyzing public comments. TRG developed DocketScope based on best practices honed by decades of experience analyzing comments for hundreds of rulemaking projects. Governments, organizations, and government contractors use DocketScope through a subscription agreement. Learn more about DocketScope at https://www.docketscope.com/ and by emailing info@DocketScope.com or TRG@reg-group.com.

E-Government (electronic government) refers to the Federal Government’s focus on providing improved and secure online access for the public to its business processes. On December 17, 2002, Congress passed the E-Government Act of 2002 (Pub. L. No. 107-347, 44 U.S.C. §§ 3601-3606). The E-Government Act of 2002 defines E-Government as follows:

Section 3601

(3) ‘electronic Government’ means the use by the Government of web-based Internet applications and other information technologies, combined with processes that implement these technologies, to—

(A) enhance the access to and delivery of Government information and services to the public, other agencies, and other Government entities; or

(B) bring about improvements in Government operations that may include effectiveness, efficiency, service quality, or transformation.

E-rulemaking (or electronic rulemaking) refers generally to the use of digital technologies to enhance the ability of the public to participate in the development of Federal agency rules and regulations. E-rulemaking has been made a reality in the Federal Government through the development of the Regulations.gov website.

The term “ex parte” means “on one side only.” In administrative actions, ex parte communication means an off-the-record communication from one participant in a proceeding to a decisionmaker in that matter. Usually, the person communicating with the decisionmaker in this manner does not want other persons to know about the contact or to know what was said. Ex parte communications are deemed to be improper in contested proceedings in our judicial system. If a judge is to render an impartial decision based on evidence presented in a courtroom, the judge should not have private meetings with one side of a case and listen to arguments that the other side has no opportunity to rebut. Therefore, ex parte communications are prohibited in judicial situations, including administrative adjudication.

Traditionally, however, the rationale for prohibiting ex parte communications did not apply to the legislative process. Legislators, whether they are members of Congress or the city council, are free to talk to constituents, lobbyists, or anyone else on issues before them, so, since agency rulemaking is considered a quasi-legislative process, the APA’s bar on ex parte communications does not apply to agency rulemaking unless it is “formal” rulemaking, or perhaps in certain rulemakings where a few parties are contesting over a valuable privilege. Agencies, however, are free to establish stronger rules limiting ex parte communication in rulemaking and many have, based on ACUS Recommendation 77-3 (and more recently Recommendation 2014-4). Most such rules limit ex parte contacts after the NPRM and provide that, if such contacts do occur, they have to be documented and placed in the rulemaking record.

An Executive Order (E.O.) is one formal way the President directs executive branch agencies, other than independent regulatory agencies, to act. Presidents also issue Proclamations which can contain requirements, although in recent years most Presidents have used Proclamations only for announcing ceremonial events like Thanksgiving, Mother’s Day, and National Country Music Week. Presidents also issue Presidential memoranda, which have a little less formality in their preparation, but are still binding on executive officials.

While Executive Orders are directed to officials in the executive branch of government, and do not provide the public with judicially enforceable rights, an Executive Order can have important indirect impacts on private citizens. Since the time of President Nixon, one important use of Executive Orders has been to assert White House review over executive agency rulemakings. (See Presidential Review of Rules.)

The Federal Advisory Committee Act (FACA) (1972) (5 U.S.C. App.) is a law that establishes procedures an agency must follow when seeking advice from an outside group, unless the authorizing statutes specifically excludes its application. FACA is intended to ensure the information is objective and accessible to the public. It includes requirements for the chartering of advisory committees, committee membership (including conditions on the participation of Government employees), and public participation at open meetings. The General Services Administration (GSA) has Government-wide oversight authority under FACA. GSA’s implementing regulations are published in 41 CFR Chapter 102-3. Agencies must keep FACA in mind when planning consultations with outside groups before or during the rulemaking process.

The Federal Register is a publication of the Office of the Federal Register, National Archives and Records Administration (NARA). The Federal Register is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents. The Federal Register is published every weekday except federal holidays and is available online. The Federal Register was established in 1935 by the Federal Register Act. Over the years, numerous laws and Executive Orders have expanded and modified the use of the Federal Register in the Federal rulemaking process.

The four sections of the Federal Register are titled “Presidential Documents,” “Rules and Regulations,” “Proposed Rules,” and “Notices.” The “Presidential Documents” section contains the President’s Executive Orders, Proclamations, and other documents that the President orders published in the Federal Register. The “Rules and Regulations” section contains: (1) the text of the final rules that will appear in the next edition of a specific Title of the Code of Federal Regulations and (2) a preamble containing background and explanatory material to help the reader understand the purpose and effect of the rule. The “Proposed Rules” section announces rules that agencies expect to issue in the future and, in most cases, provides the proposed text of those rules. (See Informal Rulemaking, Advance Notice of Proposed Rulemaking, and Notice of Proposed Rulemaking.) The “Notices” section contains documents that agencies are required to publish or choose to publish in the Federal Register that are not part of the codified regulations system. Examples are announcements of meetings, hearings, and investigations; delegations of authority; notice of petitions or applications; and availability of agency reports, studies, guidelines, and environmental impact statements.

Federalism concerns the relationships between the Federal Government and state, local, and tribal governments. It involves two main issues: (1) the need for the Federal government to consult regularly with such governments and (2) when, and under what conditions, Federal law should preempt state, local, and tribal law. Executive Order 13132, issued in August 1999, states that Federal regulations may preempt state and local laws and rules only when Congress expressly dictates they do so or gives the executive agency clear authority to supersede state and local government. It specifies that, where state rules directly conflict with Federal law, the latter shall be supreme. The Order also gives the Office of Management and Budget (OMB) authority to enforce E.O. 13132 by rejecting regulations with federalism implications that preempt state law that lack a “federalism summary impact statement” or have been written without consultation with state and local officials. The executive order also makes it easier for state and local governments to get waivers from Federal rules and requires Federal officials to defer to states whenever possible. (See also Unfunded Mandates Reform Act.)

Formal rulemaking is a type of rulemaking in which the agency, by statute, may issue a rule only after an opportunity for a “hearing on the record.” Such a proceeding must be conducted according to the formal hearing provisions of the APA (5 U.S.C. §§ 556-557). Because such procedures are quite cumbersome for rulemaking, few statutes now require formal rulemaking. 

            The Freedom of Information Act (FOIA) (5 U.S.C. § 552) amended the “Public Information” requirements of the Administrative Procedure Act. Although current section 552 still contains the publication requirements of the original Administrative Procedure Act and is one of the U.S.C. sections collectively referred to as the Administrative Procedure Act, section 552 itself is typically referred to as the Freedom of Information Act. Section 552 requires that Federal agencies make certain information available to the public—either affirmatively or upon request. Before the enactment of FOIA in 1966, except for those types of information either subject to discovery in litigation with the government, or required by law to be made public, Federal agencies could arbitrarily decide what documents to release to the public and who could receive certain types of information. Now agencies are required to release to any requester copies of documents that do not fall into one of nine specifically exempt categories. These categories are:

1.         Classified national defense or foreign policy documents.

2          Materials related solely to an agency’s personnel rules and practices.

3.         Materials specifically exempted from disclosure by statute.

4.         Trade secrets and commercial or financial information obtained from a person and that is privileged or confidential.

5.         Inter-agency or intra-agency memoranda or letters.

6.         Personnel or medical files the disclosure of which would be an invasion of personal privacy.

7.         Investigatory records compiled for law enforcement purposes.

8.         Information concerning financial institutions.

9.         Geological information concerning wells.

After receiving a written request for information under FOIA, an agency has 20 working days (subject to one extension) to either comply with the request or send a written denial specifically invoking one or more of the exemptions. The denial letter must also contain instructions for appealing the decision within the agency. If an agency also rejects the appeal, the requester has the option of taking the agency to court.

If parts of documents are deemed exempt from release, the agency must release the rest of the document where feasible. Agencies retain the discretion to release exempt documents in many situations. The Act also provides rules concerning fees that may be charged to requesters.

The FOIA was updated by the 1996 Electronic Freedom of Information Act Amendments (Pub. L. No. 104-231) and the Open Government Act of 2007 (Pub. L. No 110-175).

The Government in the Sunshine Act of 1976 (5 U.S.C. § 552b), like the Freedom of Information Act, is another “openness” reform designed to make the internal decisionmaking process of regulatory agencies more accessible and subject to public scrutiny. The Act applies only to multi-member boards or commissions, headed by two or more persons who are appointed by the President and confirmed by the Senate. The Act requires these agencies to open to the public any meeting where a quorum of the governing body discusses official agency business, unless the agency plans to discuss matters falling into one of ten exempt categories. These categories are similar to those established under FOIA for denying information requests. The agencies are required to announce any open or closed meetings seven days in advance and to publish a notice in the Federal Register.

The implementation of the Government in the Sunshine Act is somewhat mixed. Agencies vary in their inclination to close their meetings, as well as in their willingness to provide the background papers that can help make the discussion at the meetings more understandable to the members of the public in attendance.

Guidance is an all-inclusive term used to describe interpretive rules, policy statements, and other materials issued by agencies to explain the meaning of, or provide advice about, their statutes or regulations. For example, the Federal Aviation Administration has an Advisory Circular System; the Nuclear Regulatory Commission has Regulatory Guides. Virtually every regulatory agency has comparable publications. Also, virtually every agency states clearly that its guidance material is just that—a guide—and is not intended to be binding. While this may be true as a technical matter—because to be binding a regulation must be issued after notice-and-comment rulemaking—some agencies give their guidance a great deal of practical effect. Indeed, in the hands of many Federal field office employees, guidance material often becomes indistinguishable from enforceable regulations. Thus, from the perspective of a person who must deal with a Federal regulatory agency, guidance can be just as important as actual regulations.

 In most agencies, the volume of guidance material usually far exceeds the volume of legally enforceable regulations. There are several reasons for the wide use of guidance. In most situations, it is much easier to issue guidance than a regulation. Guidance does not have to be published for public comment (see Rulemaking Exceptions), and in most agencies it does not have to be approved at as high a level as regulations. Thus, when questions arise about the meaning of a regulation or about acceptable methods of complying with a regulation—and such questions arise constantly—the easiest way for an agency to respond is by issuing guidance. Guidance is frequently issued as a result of pressure from the regulated public who insist on more specific direction than the regulation contains. Most guidance is issued to answer questions, not because the agency is deliberately attempting to skirt the rulemaking requirements.

Similarly, the fact that an agency’s field staff treats guidance material as if it were “mandatory” is more a result of a large and scattered bureaucracy than it is deliberate. When a regulation is vague—as regulations often are—and when someone wants an answer to a specific question that could require a considerable exercise of judgment, it is not unusual for a field office employee to look to guidance material for answers. The citizen who must comply with a general regulation is often forced to make a choice between asking for a new interpretation—which could mean months of delay—or complying with the “acceptable” directions Washington headquarters has set down as guidance. Thus, guidance material issued with the best of intentions frequently becomes binding in day-to-day practice.

ACUS Recommendations 76-5, 92-2, 2014-3, 2017-5, and 2019-1, and OMB’s “Good Guidance Practices” Bulletin (January 18, 2007), provide best practices for agencies.

Hybrid rulemaking, as its name implies, is a cross between informal and formal rulemaking procedures. Hybrid rulemaking results when Congress directs an agency to follow specific procedural requirements in addition to those required by the informal rulemaking procedures of the Administrative Procedure Act (APA). This requires agencies to comply with procedures that are more formal than the APA’s notice-and-comment, informal rulemaking, but less formal than on-the-record, trial-like, formal rulemaking. Various hybrid procedures include creation of a formal record, oral hearings, allowing interested persons to submit oral testimony, multi-stage rulemaking, and issuance of detailed findings and reasons. Some significant regulatory statutes, mostly enacted in the 1970’s, such as the Clean Air Act, the Occupational Safety and Health Act, and the Federal Trade Commission’s rulemaking statute, require hybrid rulemaking.

Before completing the rulemaking process, statutes and Executive Orders require Federal agencies to perform various impact analyses and publish the resulting “impact statements.” Impact statements provide the public with information about the expected effects of the rulemaking. The earliest such impact analysis requirement is found in the 1970 National Environmental Policy Act (NEPA), which requires “environmental impact statements” for Federal actions that have a significant impact on the human environment. Other impact statements are required by the Regulatory Flexibility Act, the Unfunded Mandates Reform Act, and the Paperwork Reduction Act. Numerous Executive Orders require similar analyses of economic costs and benefits, federalism, takings of private property, energy supply or use, and the impact on the courts, children’s health, and Indian tribes. For OIRA guidance on performing impact analyses, see OIRA's Regulatory Impact Analysis Primer, issued August 15, 2011. (See Cost-Benefit Analysis)

Incorporation by reference (IBR) is a technique used by Federal agencies to include, and make enforceable, materials published elsewhere without republishing those materials in full text in the agencies’ regulations. Most typically, this technique is used by agencies to incorporate widely used voluntary industry-developed standards such as the National Fire Protection Code.

The Administrative Procedure Act (5 U.S.C. § 552(a)(1)) requires each agency to obtain the approval of the Director of the Office of the Federal Register for each document it wishes to incorporate by reference. Regulations governing this approval are set out in Part 51 of Title 1 of the Code of Federal Regulations.

In the early 2000s, questions were raised about the impact of the advent of e-rulemaking on incorporation by reference of voluntary industry standards. E-rulemaking made it much more feasible for agencies to publish, for comment and compliance purposes, the full text of such standards in proposed and final rules, but many such standards are copyrighted. ACUS issued Recommendation 2011-5 on Incorporation by Reference and the Office of the Federal Register updated its regulations on IBR on November 7, 2014 (79 FR 66278) and issued an IBR Handbook in 2016.

The term “independent regulatory agency” is used to refer to Federal agencies that have been established by Congress to have a certain amount of independence from the President. Although their attributes depend on their individual statutes, most independent regulatory agencies are multi-member boards and commissions such as the FCC, FTC, NLRB, and SEC. Although the President appoints the members, he usually may not choose more than a bare majority from his own party. While the President typically may select the chairperson, he may not seek to remove members without “cause.” Such an agency also may have special authority to transmit its budget or legislative proposals to Congress without OMB approval and/or to litigate in court independent of the Department of Justice.

Despite these important structural differences, these agencies operate under the APA and most other procedural statutes in the same way that departments and other agencies do. There are, however, a few significant differences. Independent regulatory agencies have not been made subject to most provisions of Presidential Executive Orders. Therefore, the independent regulatory agencies do not have to submit their rules to OIRA for review under E.O. 12866—although they are required to participate in the Unified Agenda. Independent regulatory agencies are also specifically exempted from the Unfunded Mandates Reform Act. Under the Paperwork Reduction Act, independent regulatory agencies are empowered, by majority vote, to override an OMB rejection of an information collection request. That Act contains the only statutory definition of “independent regulatory agency”—see 44 U.S.C § 3502(5) (containing a non-exclusive list of 19 such agencies).

Informal rulemaking, also called “notice-and-comment rulemaking” and “Section 553 rulemaking,” is the rulemaking process set out in Section 553 of the Administrative Procedure Act (APA). Informal rulemaking is to be distinguished from the rarely used formal (trial-type) rulemaking. (See Formal Rulemaking) In its most basic form, it involves: (1) publishing a proposed rule in the Federal Register; (2) inviting public comment; (3) considering the public comment; and (4) publishing a final rule in the Federal Register. But beyond these APA procedures, many other requirements added by other statutes and Executive Orders apply to the process and this has made informal rulemaking more formalized.

The informal rulemaking process is intended to be a legislative-like process in which the rulemaker, like a legislator, gives the public an opportunity to influence the regulatory decision. Under the APA, any “interested person” may submit comments. Thus, each informal rulemaking action has the potential to be like a national town hall meeting; anyone who wants to may participate. Most informal rulemaking is now e-rulemaking, although paper comments are still accepted.

According to the APA’s informal rulemaking procedures, an agency has discretion when deciding whether or not to hold an oral hearing. (Sometimes an agency’s own statute requires it to hold hearings in certain rulemaking matters; see Hybrid Rulemaking.) If an agency decides to hold a hearing, the agency sets the ground rules for the hearing. The hearing may be a very informal legislative-like one at which people read or state their views for the record or it may be very formal with sworn witnesses and cross-examination.

It should be noted that some types of rules are exempt from notice-and-comment procedures (see Rulemaking Exceptions).

An Information Collection Request (ICR) is a request an agency makes to the OMB Office of Information and Regulatory Affairs (OIRA) for approval of a “collection of information” as broadly defined by the Paperwork Reduction Act. The ICR is a set of documents that describe reporting, record keeping, survey, or other information collection requirements imposed on the public by a Federal agency. Each request must be sent to and approved by the Office of Management and Budget before a collection begins. The ICR provides a justification for the collection and estimates the cost and time for the public to respond. The agency submits the ICR to OIRA through an electronic system called ROCIS. (See ROCIS.) Independent regulatory agencies have the power under the Act to override an OIRA veto of an ICR by a majority vote. However, this power is rarely exercised.

Section 553 of the APA contains a number of exceptions for certain types of rules that allow agencies to skip the proposed rulemaking step and go directly to a final rule. (See Rulemaking Exceptions.) The “interim final rule” is a device that agencies have used increasingly in recent years to go directly to publishing a final rule while still providing some opportunity for public comment. This technique is not mentioned in the APA. It is typically used when the agency has a “good cause” argument for skipping the NPRM stage. The “good cause” exception covers situations when an agency finds that inviting public comment would be “impracticable, unnecessary, or contrary to the public interest.” In effect, the agency issues a final rule without a prior NPRM and invites post-promulgation opportunity for comment. This technique is most often used (and more easily justified) when an agency is acting under a new law that requires the agency to take certain regulatory action within a specified and short period of time after the law takes effect. Using “final rule with request for comments” as the term for this rulemaking action would be more accurate than the term “interim final rule,” because “interim” suggests the action will have a termination date and most do not.

This technique was originally invented by the Federal Aviation Administration and given the name “Final Rule with Request for Comments.” This original name is a better choice than “Interim Final Rule.” The word “interim” implies that the rule will only exist for a finite duration. If the document does not specify a termination date, then labeling it “interim” is misleading.

An interpretive rule is a document an agency issues to explain its own regulations or to explain the meaning of a statute that it administers. The Administrative Procedures Act permits an agency to issue interpretive rules without following the notice-and-comment procedures. See Perez v. Mortgage Bankers Assoc., 575 U.S. 92 (2015). (See Rulemaking Exceptions)

Sometimes an agency, in the guise of “interpreting” a law or regulation, may add new content or requirements. These interpretations may be challenged in court. In such an instance, a challenger may succeed in persuading a reviewing court to invalidate the interpretation for failure to follow notice-and-comment procedures. See e.g., Hoctor v. U.S. Dep’t of Agriculture, 82 F.3d 165 (7th Cir. 1996). As with other forms of guidance, each document must be examined individually to determine whether it is what it purports to be. (See Guidance.)

Agencies sometimes issue interpretations or rulings that are applicable to (and may only be relied on by) the individuals who request them. An Internal Revenue Service “Letter Ruling” is an example.

Judicial review is the process by which the courts determine the validity of agency actions. Judicial review is governed by the provisions in sections 701-706 of the APA, plus any specific provisions in the agency’s organic or program statutes. With respect to court challenges to agency rules, there are three basic grounds for arguing that the rule is invalid: (1) the agency did not have authority to issue the regulation; (2) the agency did not follow proper procedure in issuing the regulation; or (3) there was insufficient “evidence” to support the agency decision to issue the regulation. With respect to the third ground, under the APA, a court reviewing a regulation issued under “informal rulemaking” procedures is not supposed to invalidate a rule on substantive grounds unless the rule is found to be “arbitrary or capricious.” A slightly different test is used if the rule being reviewed was issued under “formal rulemaking” procedures and some “hybrid” rulemaking statutes—the court looks to see if there was “substantial evidence” to support the agency decision. But court interpretations of these two tests have indicated that there is not much difference between their respective applications. (See Arbitrary-or-Capricious Test.)

 When a court finds that an agency rule is arbitrary or capricious or was issued after improper procedure, normally the court will vacate the rule and remand it to the agency. For example, if an agency did not go through the proposed rulemaking stage, a court could decide that the agency did not have sufficient grounds for skipping that stage and could order the agency to start over again.

Before 1970, there were few cases involving judicial review of the rulemaking actions of Federal agencies. One of the major reasons was because a person would have had to risk noncompliance to precipitate a challenge. This made judicial review very unlikely. However, the Supreme Court made it possible for a regulation to be challenged before enforcement at about the same time that Congress was enacting numerous new laws that spawned a large volume of Federal regulations. (See Abbott Laboratories v. Gardner, 387 U.S. 136 (1967)). The result was a great increase in court challenges to agency rules.

Throughout the 1970s, Federal courts raised questions about the adequacy of the procedures that agencies followed in issuing their regulations. Sometimes courts ordered agencies to hold hearings or allow cross-examination of witnesses during informal rulemaking procedures even though the APA does not have such a requirement. However, the Supreme Court, in Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519 (1978), put a stop to this by stating emphatically that courts must not require additional procedures not mandated by the APA or any other statute.

The notice-and-comment process is designed to allow agencies to learn from public comments and to make appropriate changes in the final rule based on the comments. Sometimes, however, the result is that the final rule is significantly different from the proposed rule. In such instances, parties who dislike the changed final rule sometimes claim that they were not given adequate notice that the agency was considering such important changes. Another phrase used to discuss the same concern is inadequate "scope of the notice.”

To address such challenges, reviewing courts developed the “logical outgrowth test.” The court determines whether the provisions of the final rule logically grow out of the terms of the proposed rule. If so, then the commenters are deemed to have received adequate notice. If not, then the agency will be ordered to undertake a new round of notice and comment. The “logical outgrowth test” was largely a product of the lower courts, but the Supreme Court adopted the test in 2007. (Long Island Care at Home, Ltd. v. Coke, 551 U.S. 158 (2007).)

Loper Bright Enterprises v. Raimondo, 603 U.S. ___ (2024) rejected the longstanding principle of Chevron deference, under which courts deferred to Federal agencies’ interpretations of ambiguous laws. (See Chevron Deference.)

Under the Loper Bright Doctrine, authority to resolve these ambiguities resides with the courts, which must use their own judgment to determine if an agency has acted within its legal boundaries according to the Administrative Procedure Act. The Loper Bright decision states that, in the absence of Chevron deference, courts should apply the lesser level of deference put forth in Skidmore to ensure that they properly take into account an agency’s “body of experience and informed judgment” when making their determinations. (See Skidmore Test.)

The Major Questions Doctrine is a principle regarding congressional delegation of agency authority. It presumes that Congress does not delegate authority relating to issues of great economic and political significance unless it has given the agency clear authorization. In the last several years before the Supreme Court overturned the Chevron Doctrine in Loper Bright Enterprises v. Raimondo, 603 U.S. ___ (2024), Federal courts began relying on the Major Questions Doctrine in cases where they might otherwise have applied Chevron. (See Chevron Doctrine, Loper Bright Doctrine.)

Supreme Court cases applying the Major Questions Doctrine include West Virginia v. EPA, 597 U.S. ___ (2022), Ala. Ass’n of Realtors v. Dep’t of Health & Hum. Servs., 594 U.S. ___, (2021), and Biden v. Nebraska, 600 U.S. ___ , (2023).

The National Environmental Policy Act (NEPA) (1970) (42 U.S.C. 4321-4347) requires all Federal agencies to include a detailed environmental impact statement in every proposal for a major Federal action (including rules) that significantly affect the quality of the human environment. The environmental impact statement must address the subjects and apply substantive criteria set forth in the Act. The Council on Environmental Quality (CEQ) issued regulations to implement the procedural provisions of NEPA (40 CFR parts 1500-1508). Every agency with legislative rulemaking authority should have supplementary regulations establishing its procedures for assessing the need for an environmental impact statement and for preparing and obtaining comments on such statements.

Negotiated rulemaking (sometimes known as “regulatory negotiation” or “reg-neg”) is a technique used by Federal agencies to bring interested parties into the rule-drafting process at an early stage.

In negotiated rulemaking, the agency announces in the Federal Register that it is considering using reg-neg and seeks interested participants. The agency, then, with the assistance of a neutral adviser known as a “convenor,” assembles a committee of representatives of all affected stakeholders to negotiate the text of a proposed rule. (This aspect of the process is subject to the Federal Advisory Committee Act) The goal of the process is to reach consensus on a policy decision and text that all parties can accept. The agency is also represented by an official who is able to speak authoritatively on behalf of the agency. Negotiating sessions are chaired, not by the agency representative, but by a neutral mediator or “facilitator” skilled in assisting in the resolution of multi-party disputes. If the committee achieves consensus, the agency generally publishes the draft rule based on that consensus in a notice of proposed rulemaking—and the agency would have committed itself in advance to doing so. Even negotiations that fail to result in consensus on a draft rule can be very useful to the agency by narrowing the issues in dispute.

Negotiated rulemaking should be viewed as a supplement to the rulemaking provisions of the Administrative Procedure Act (APA). This means that the negotiation sessions generally take place prior to the issuance of the notice of proposed rulemaking. Negotiated rulemaking does not reduce in any way the agency’s obligations to follow the APA process, to produce a rule within its statutory authority, or to adequately explain the justification and result.

Congress has endorsed this process in the Negotiated Rulemaking Act of 1990, (5 U.S.C. § 561-570), and it is also endorsed in E.O. 12866.

The notice of proposed rulemaking (NPRM, NPR, NOPR) serves to inform the public that a Federal agency is considering a regulatory change. The NPRM must be published in the Federal Register unless all of the persons who would be subjected to the proposed change are named and either personally served or otherwise have actual notice. The NPRM describes the new rule or changes being considered in existing rules, and tells the public how they may participate in the rulemaking process. Although the APA is silent on the length of the comment period, most courts have required at least 30 days and E.O. 12866 suggests that at least 60 days is appropriate for most rules. In most cases, the public is invited to participate by submitting written comments to the agency. If the agency plans to hold a public hearing, the time and place of the hearing are often announced in the NPRM. If the agency does not decide to hold a public hearing until after the NPRM is published, the hearing is usually announced in a separate Federal Register document.

No particular format is required for written comments. They may be as simple as a letter or postcard or as formal as a printed legal brief. The great majority of comments are now filed electronically, either on the agency’s website or on Regulations.gov. Most agencies maintain all of the comments received on a particular NPRM in a single file, usually referred to as the “docket.” Before an agency issues a final rule, it is required (by the courts) to consider all comments it receives in response to an NPRM and to include a response to significant comments in the preamble to the final rule.

The term "notice-and-comment rulemaking" is used synonymously with "informal rulemaking." It refers to the process that agencies must use to issue rules under section 553 of the APA. It basically has four steps: a notice of proposed rulemaking (NPRM), a comment period, promulgation of the final rule, and a 30-day delay in the effective date. Other statutes and executive orders have added additional requirements to this APA process. (See Informal Rulemaking.)

The Office of Information and Regulatory Affairs, usually known by its acronym, OIRA, is an important office in the Office of Management and Budget. The Paperwork Reduction Act of 1980 created OIRA to administer the requirements of that Act. OIRA was also subsequently assigned the responsibility to oversee the process of Presidential review of rules. Thus, OIRA has become the central office of regulatory review for the White House. Its Administrator is appointed by the President subject to Senate confirmation.

An organic statute is a law that establishes a Federal agency. The Atomic Energy Act and Federal Aviation Act are examples. An organic statute often gives an agency specific authority to issue rules and regulations. In such cases, it may also be called an "enabling statute" or the agency's "statutory authority." The latter two terms also may include "program statutes" or laws that give an agency authority to act in a certain area. An example is the Noise Control Act of 1972, which gives the FAA authority to regulate aircraft noise.

The Paperwork Reduction Act of 1980 (44 U.S.C. §§ 3501-3520) (PRA) superseded the older Federal Reports Act (1942) and reestablished the Office of Management and Budget (OMB) as the central coordinator of Federal information policy. The PRA was reenacted and updated in 1995. The Act requires all agencies to obtain the approval of the Office of Information and Regulatory Affairs (OIRA) in OMB before requesting the same type of information from ten or more businesses and individuals. OIRA also decides whether or not the information requested is duplicative or puts an excessive burden on the public. (See Information Collection Request and Office of Information and Regulatory Affairs.)

OIRA’s regulations provide for a different process for reviewing and clearing free-standing information collection requests (e.g., tax forms) and information requests embedded in proposed regulations.

A regulation written as a performance standard (a.k.a. performance-based regulation) tells the regulated party the desired outcome of the regulation, but does not specify how to achieve that outcome. Performance standards are contrasted with prescriptive regulations (i.e., specification standards, “command-and-control” regulations). With performance standards, regulated entities are responsible for meeting a particular regulatory target, but they are free to choose or to invent the most efficient method of compliance. While regulated industries often prefer performance standards, many guidance documents are issued in response to requests from regulated entities for specifics on how to meet a performance standard.

Plain language, sometimes called Plain English or Plain Writing, is communication an audience can readily understand the first time they read or hear it. In the administrative law arena, plain language is writing that clearly explains what the Federal Government requires and why, in an effort to improve the relationship between the Government and the public it serves. On June 1, 1998, President Clinton issued a memorandum requiring the use of plain language in Government documents, both regulatory and non-regulatory, that are intended to be read and used by the public (63 Fed. Reg. 31,885; June 10, 1998). In addition to the President Clinton Memorandum, agencies are also instructed to write clear documents by the Paperwork Reduction Act and several Executive Orders (e.g., E.O. 12866, E.O. 12988, E.O. 13563). In spite of the redundancy, on October 13, 2010, Congress passed the “Plain Writing Act of 2010” (Pub. L. No. 111-274, 124 Stat. 2861). The stated goal of the law was to establish that “Government documents issued to the public must be written clearly.” For unknown reasons, the unnecessary (clear writing is important, but more mandates to write clear documents isn’t the solution) law  specifically excludes “regulation” from the requirement to write clearly. On April 13, 2011, the Office of Information and Regulatory Affairs issued a memorandum implementing the Plain Writing Act of 2010 (M-11-15) and listing the other Federal mandates requiring that regulations also must be written clearly.

Some of the techniques of plain language are writing skills—using simple words and phrases instead of unnecessarily complicated word choices. Others are presentation skills—displaying the information in a way that is readable and visually appealing. The principles of plain language to remember include:  (1) Use reader-oriented writing. Write for the customers, not for other Government employees. (2) Use natural expression. To the extent possible, write as you would speak. Write with commonly used words in the way that they are commonly used. (3) Make your document visually appealing. Present the text in a way that highlights the main points you wish to communicate.

A preamble is the part of a rulemaking document, usually published in the Federal Register, that explains the reasons for the regulatory action of a Federal agency. The preamble of a proposed rule contains information about the basis for the proposal, possible hearings, contact persons, comment dates, and related materials that are available to the public. The preamble of a final rule contains the statement of “basis and purpose” of a regulation as required by the Administrative Procedure Act. This also normally includes the agency’s response to comments filed by the public.

A preamble is not a part of the regulatory text, and therefore does not appear in the Code of Federal Regulations. A preamble is not legally enforceable, but it is an important aid in gaining an understanding of why an agency is acting or refusing to act. A preamble is also part of the “informal record”—the material that would be reviewed by a court to determine if an agency has acted in an arbitrary or capricious manner.

For many years, Congress delegated rulemaking authority to executive branch agencies, and that authority was usually exercised without direct Presidential involvement. As concerns about both the volume and the impact of Federal regulations grew in the mid-1970s, each successive President tried to gain control over the rulemaking activities of his appointed officials. Presidential review of rules began with President Nixon (limited to EPA), was continued by Presidents Ford and Carter, and was pushed even further by President Reagan. In Executive Order 12291, Reagan required that the Office of Management and Budget (more specifically the Office of Information and Regulatory Affairs (OIRA)) approve nearly all regulations before they are issued. In E.O. 12498, he went on to establish a longer-term regulatory planning process. President Clinton issuedE.O. 12866 on September 30, 1993, and revoked E.O. 12291 and E.O. 12498. In E.O. 12866, President Clinton continued OIRA review of agency regulations, but limited that review to “significant regulatory actions.” His Order also increased the transparency of the review process. President Bush twice amended E.O. 12866 by issuing E.O.s 13258 (2002) and 13422 (2007). Both of these E.O.s were revoked by President Obama in 2009 with E.O. 13497. On January 18, 2011, President Obama issued E.O. 13563, Improving Regulation and Regulatory Review. This E.O. amplified the mandates in E.O. 12866 and requires agencies to perform periodic retrospective regulatory review. (See Retrospective Regulatory Review). From 2017 through 2019, President Trump issued E.O. 13771, Reducing Regulation and Controlling Regulatory Costs, E.O. 13777, Enforcing the Regulatory Reform Agenda, E.O. 13891, Promoting the Rule of Law Through Improved Agency Guidance Documents, and E.O. 13892, Promoting the Rule of Law Through Transparency and Fairness in Civil Administrative Enforcement and Adjudication. All of these E.O.s sought to provide more Presidential review of rules. President Biden revoked these four E.O.s, as well as E.O.s 13875 and 13893, on January 20, 2021, with E.O. 13992, Revocation of Certain Executive Orders Concerning Federal Regulation. President Biden made minor edits to EO 12866 on April 6, 2023, with EO 14094, Modernizing Regulatory Review.

Traditionally the review conducted by OIRA applies only to regulations of purely executive agencies (i.e., the Cabinet Departments and certain other agencies, like EPA). It does not apply to the “independent regulatory agencies” such as the FCC, FTC, and SEC. However, President Obama issued a follow-up E.O. 13579, extending the terms of E.O. 13563 to the independent regulatory agencies. In December 2020, the Department of Justice’s Office of Legal Counsel published a 2019 memo titled "Extending Regulatory Review Under Executive Order 12866 to Independent Regulatory Agencies." This memo laid out legal arguments justifying the authority for extending presidential review over independent regulatory agencies.

OMB has performed a similar review function with respect to agency legislative proposals for many years.

The Privacy Act (5 U.S.C. § 552a) was enacted in 1974 in response to rapidly developing computer technology. There was a growing fear that this technology would allow the Federal Government to amass a large amount of information on individuals without their consent or without informing them how the information would be used or disseminated. The Privacy Act protects individuals by requiring Federal agencies to make public what “system of records” they maintain on individuals and to inform individuals about how any personal information will be used prior to collecting it. In addition, any person can request copies of the records an agency has on him or her and may make corrections or amendments to any portion of the information that he or she feels is inaccurate. No one except the individual named can request copies of any material containing personal information. The Privacy Act is similar to the Freedom of Information Act (FOIA) in that there is an elaborate system of procedures and exemptions that agencies follow in responding to requests for information. There is a tension between the Privacy Act and FOIA. The former is intended to protect certain Government-held information from disclosure, while the latter is intended to promote disclosure.

A regulation is a common name for an agency rule that imposes regulatory (binding) requirements, although it is not a term used in the APA. Regulations are also sometimes called “substantive” or “legislative” rules. Under the APA, “regulations” are a subset of “rules,” but the two terms are often used interchangeably. (See Rule).

Following early initiatives in the Clinton and Bush (II) administrations and spurred by the enactment of the E-Government Act of 2002, the government established the eRulemaking Program based within EPA. Under the program EPA developed and has gradually refined the central rulemaking portal, www.Regulations.gov. The website serves as a central place for the public to comment on pending proposed rules and review comments filed by others, and as an archive for the dockets of past rulemakings.

In October 2019, the eRulemaking Program was moved to GSA. GSA established a Program Management Office to oversee the system development, maintenance, and collaboration of agency partners. In addition, an Executive Committee, composed of Chief Information Officers, Regulatory Policy Officers, and Deputy Secretaries from 30 departments and agencies helps to govern the operation of the website. An Advisory Board is made up of senior representatives from partner agencies, and workgroups provide additional technical and business process expertise in a variety of areas, including usability, budget, and legal issues.

A regulatory agency is a common name for an agency that has been delegated authority by Congress to issue regulations, to issue licenses, to establish rates, or to undertake a combination of these actions. Traditionally, when people referred to a “regulatory agency,” they usually had in mind one of the multi-member, “independent” regulatory boards or commissions, like the FCC or FERC, that issue licenses and otherwise regulate the economic status of a particular industry. (See Independent Regulatory Agency.) But in recent years Congress has given more and more regulatory authority to executive branch departments and single-headed agencies, such as OSHA in Labor, NHTSA in Transportation, and EPA. Today there are at least 100 regulatory agencies of the Federal Government.

A semi-annual regulatory agenda and regulatory flexibility agenda are published every spring and fall by each Federal agency. The official name for the publication is the Unified Agenda for Regulatory and Deregulatory Actions. E.O. 12866 requires that the agenda description of each pending regulatory action “shall contain, at a minimum, a regulation identification number [‘RIN’], a brief summary of the action, the legal authority for the action, any legal deadline for the action, and the name and telephone number of a knowledgeable agency official.” The Regulatory Flexibility Act requires agencies to list those proposed rules that are likely to have a significant impact on small businesses and other small entities. The Unified Agenda combines these two agendas into one document. The publication of these agendas allows individuals and businesses to get involved in the rulemaking process long before the agency has reached the proposed rule stage. The Unified Agenda is compiled by the Regulatory Information Service Center (RISC), an agency within GSA, and is made available to the public online (http://www.reginfo.gov/public/do/eAgendaMain). (See also ROCIS).

The Regulatory Flexibility Act ("Reg Flex") (1980) (5 U.S.C. 601-612) requires regulatory agencies to consider the effects of any proposed rule on "small entities" (i.e., small businesses, small governmental units, and small not-for-profit organizations). For any rule that an agency determines will affect a significant number of small entities, a Regulatory Flexibility Analysis (RFA) must be prepared at both the proposed rule and final rule stages. This analysis must include: (1) an estimate of the number and type of small entities to be affected; (2) a detailed description of the recordkeeping and compliance requirements for the rule; and (3) a discussion of the alternatives that the agency has considered that would reduce the burden that the rule would impose on small entities. In April and October of each year, all regulatory agencies are required to publish in the Federal Register a "regulatory flexibility agenda" listing all rules that the agency is likely to issue in proposed or final form that are expected to have significant impact on small entities. Each year the agency must publish a list of those rules it intends to review within the next 12 months. (See Regulatory Agendas.)

The Regulatory Flexibility Act was amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA, Public Law 104-121, Title II). SBREFA added a provision allowing court challenges to an agency's non-compliance with Reg Flex. SBREFA also requires that agencies develop guidelines and provide other assistance to, and modify enforcement policy for, small businesses. It also created a system of Congressional review of agency rules. (See Congressional Review of Rules.)

Regulatory reform is a catch-all term used to describe attempts or proposals to change the way the Federal Government regulates. In its most common usage, it is a label given to a series of efforts begun during the Ford Administration that attempted to gain some control over the increasing impact of Federal regulation on the private sector. President Ford’s E.O. 11821 (Inflation Impact Statements), President Carter’s E.O. 12044 (Improving Government Regulations), President Reagan’s E.O. 12291 (Federal Regulation), President Clinton’s E.O. 12866 (Regulatory Planning and Review), President Obama’s E.O. 13563 (Improving Regulation and Regulatory Review), and President Trump’s E.O. 13771 (Reducing Regulation and Controlling Regulatory Costs) and E.O. 13777 (Enforcing the Regulatory Reform Agenda) were all “regulatory reform” initiatives. Congress passed the Paperwork Reduction Act (Pub. L, No. 96-511) and the Regulatory Flexibility Act (Pub. Law 96-354) in 1980, the Unfunded Mandates Reform Act (Pub. L. No. 104-4) in 1995, and the Small Business Regulatory Enforcement Fairness Act (Pub. L. No. 104-121, title II) in 1996 as regulatory reform measures. Deregulation of airlines, trucking, and railroads has also been included under the regulatory reform label.

In addition to the described measures, many other regulation-related laws were considered reforms at the time of their enactment. Some examples include the 1966 Freedom of Information Act (FOIA) and the FOIA Amendments of 1974; the National Environmental Policy Act of 1970; the Federal Advisory Committee Act of 1972; the Privacy Act of 1974; and the Government in the Sunshine Act of 1976.

In the past several decades, Congress has also considered different versions of “comprehensive” Regulatory Reform Acts, which would significantly amend the APA, but none have been enacted.

Retrospective Regulatory Review (also referred to as “Retrospective Analyses of Existing Rules”) refers to a “look back” requirement in Executive Order (E.O.) 13563, Improving Regulation and Regulatory Review. Section 6 of the E.O. requires agencies to periodically review significant regulations in search of regulations that “may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.” E.O. 13610 (“Identifying and Reducing Regulatory Burdens”) provided additional details about the required Retrospective Regulatory Review. E.O. 13610 requires executive agencies to submit draft reports based on their retrospective reviews to OIRA on the second Monday of January and July each year. This system of review of existing regulations is a more detailed version of similar requirements for retrospective regulatory review required by Section 5 of E.O. 12866 and predecessor Executive Orders.

The Regulatory Information Service Center (RISC) and the Office of Information and Regulatory Affairs (OIRA) have worked together to create a computer system to manage both RISC’s and OIRA’s missions. The system is known as “ROCIS” (RISC/OIRA Consolidated Information System), which is pronounced “ROW-kiss.” ROCIS supports OIRA’s ability to communicate with Federal agencies and the public. ROCIS is comprised of the regulatory agenda module, the regulatory review module, and the information collection review module. ROCIS also supports the System of Records Notices (SORN) document review module.

ROCIS allows OIRA to track agency submissions and manage its own workflow. ROCIS also provides the ability to prepare final regulatory documents in a format that agencies can use for submission to the Federal Register for publication. OIRA and RISC have been collecting data on regulations and information collections since the early 1980s. The ROCIS database contains historical data and will continue to collect and incorporate similar information on current activity. Most information submitted by agencies through ROCIS (www.rocis.gov) is available to the public on www.RegInfo.gov.

A “rule” is defined broadly in the Administrative Procedure Act to include any agency statement of future effect designed to: (1) implement, interpret, or prescribe law or policy; or (2) describe the agency’s organization, procedure, or practice requirements. As such, it includes nearly every type of agency pronouncement other than an order made in an adjudication—from the broadest substantive regulatory standard to the most trivial sort of procedural memorandum or guidance document. However, although the definition is quite expansive, the rulemaking process for rules differs depending on the nature of the rule being issued by the agency. To have the force of law, the rule must be issued under delegated authority from Congress and according to appropriate rulemaking requirements. Violation of a validly adopted rule can result in a sanction just as severe as one received for violation of a statute passed by Congress.

Agencies’ organizational descriptions and rules of general applicability adopted by agencies must be published in the Federal Register. Many of these rules must also be published first in proposed form, unless they fall within one of the exceptions from notice-and-comment. (See Rulemaking Exceptions.)

Finally, some statutes and Executive Orders require additional procedures and impact statements for certain categories of rules. (See Regulatory Flexibility Act, Unfunded Mandates Reform Act, Impact Statements, Executive Order.)  The terms “regulation” and “rule” are often used interchangeably. (See Regulation.)

Under the APA rulemaking process, agencies must normally publish a notice of proposed rulemaking (NPRM) in the Federal Register. However, the APA also contains a number of rulemaking exceptions.

Two broad categories of rules—those dealing with military or foreign affairs functions and those relating to agency management or personnel or to public property, loans, grants, benefits, or contracts—are excepted from all of the requirements of 5 U.S.C § 553. Despite these rather broad subject-matter exceptions, it should be noted that agencies engaged in rulemaking covered by these exceptions are often required by other laws or directives to use some public participation procedures. For example, the Social Security Act provides that regulations prescribing standards for benefits eligibility are subject to section 553 rulemaking procedures.

Broad exceptions from the notice-and-comment process also exist for other types of rules, such as interpretive rules, general statements of policy, and rules of agency organization, procedure, or practice. (See Guidance; Interpretive Rule.)

Finally, the APA authorizes agencies to dispense with certain procedures for rules when they find “good cause” to do so. Under section 553(b)(B), the requirements of notice and opportunity for comment do not apply when the agency, for good cause, finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.”  Section 553(d)(3) allows an agency, upon finding good cause, to make a rule effective immediately, thereby avoiding the 30-day delayed effective date requirement in section 553. These two exceptions give agencies flexibility by allowing them to dispense with procedures in promulgating rules not otherwise excepted but, like other exceptions, they are construed narrowly by the courts. Moreover, an agency must give supporting reasons for invoking the good cause exceptions.

A rulemaking record is a file normally created by the agency in informal rulemaking. (See also Docket.) At a minimum, the informal record would contain the notice of proposed rulemaking (NPRM), any studies or reports referred to in the NPRM, public comments, records of any hearings or meetings, and the final rule document. Agencies must anticipate that courts will conduct a thorough review of informal rulemaking and that they will require the agency to produce an administrative record that shows that the agency has taken a hard look at the relevant evidence and policy alternatives. Thus, it is in the agency’s interest to include in its administrative record anything that it would want to use to support its policy decisions. Although not mentioned in the APA, the development of the concept of a rulemaking record for informal rulemaking is reflected in the decisions of reviewing courts, and in certain hybrid rulemaking statutes that have detailed record requirements.

The Supreme Court narrowed the scope of when Chevron deference was applied to agency statutory interpretations in the 2001 case U.S. v. Mead Corp., 533 U.S. 218 (2001).

Mead held that “administrative implementation of a particular statutory provision qualifies for Chevron deference when it appears that Congress delegated authority to the agency generally to make rules carrying the force of law, and that the agency interpretation claiming deference was promulgated in the exercise of that authority.” The upshot of this decision was that normally an agency interpretation announced in an interpretative rule or policy statement that did not go through notice-and-comment rulemaking, or was announced in an informal adjudication, would not qualify for Chevron deference but would instead qualify for the lesser Skidmore deference based on the “persuasiveness” of the interpretation. This lesser deference derives from the Supreme Court decision in Skidmore v. Swift & Co., 323 U.S. 134 (1944). (See Chevron Doctrine.)

In rejecting the Chevron Doctrine, Loper Bright Enterprises v. Raimondo, 603 U.S. ___ (2024) provided that the Skidmore test now applies to all agency rulemaking when interpretation of statutory ambiguity is involved. (See Loper Bright Doctrine.)

Based on court decisions, if an agency makes significant substantive changes between the NPRM and the final rule, the public must be given an opportunity to comment on the revisions. (See Logical Outgrowth Test.) In such a case, the agency issues an SNPRM and considers comments on that notice before proceeding to the final rule. “Significant substantive changes” mean new requirements that go beyond the scope of the requirements proposed in the NPRM. The agency may proceed with a final rule on other parts of the proposal while comments on the SNPRM are being made.

Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. §§ 658, 1501-03, 1531-34), establishes requirements for Federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments and the private sector. The Act requires each Federal agency, excluding independent regulatory agencies, to prepare a written assessment of the effects of any proposed or final rule that contains a Federal mandate that may result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. Section 204(a) of the Act (2 U.S.C. § 1534(a)) requires the Federal agency to develop an effective process to permit timely input by elected officers (or their designees) of state, local, and tribal governments on such a proposed “significant intergovernmental mandate.” (See Federalism; Regulatory Reform.)

Although the Act is enforced in the Presidential Review of Rules process, judicial review of agency actions under the Act is quite limited.