What Is Administrative Rulemaking?

What Is Administrative Rulemaking?

Administrative agencies do not merely enforce laws passed by Congress. They also create detailed rules and regulations that give practical effect to statutes.

This process is known as administrative rulemaking.

Rulemaking is one of the most important functions of the modern administrative state because statutes often establish broad legal frameworks without specifying every technical requirement necessary to administer them.

Congress may enact a statute requiring workplaces to be reasonably safe, financial institutions to disclose certain information, medicines to meet safety standards, or environmental pollutants to remain within specified limits.

But statutes cannot realistically contain every technical detail.

Administrative agencies therefore develop rules that translate broad legislative commands into detailed and workable requirements.

The basic relationship is:

Congress passes a statute

↓

The statute delegates authority to an agency

↓

The agency develops rules within that authority

↓

The rules implement, interpret, or prescribe legal requirements

↓

Courts review the legality of the agency’s action

This process is fundamental to administrative government.

But rulemaking is not unlimited.

An agency cannot simply create whatever rules it considers desirable. Its rulemaking authority must come from a valid legal source, and the agency must comply with applicable procedural and constitutional requirements.

The central principle is therefore:

Administrative rulemaking is the legally regulated process through which an administrative agency formulates, amends, or repeals rules within the authority delegated to it.

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1. What Is Administrative Rulemaking?

The federal Administrative Procedure Act (APA) defines rulemaking as the agency process for formulating, amending, or repealing a rule. 5 U.S.C. § 551(5) provides the statutory definition. (Cornell Law School – 5 U.S.C. § 551)

Cornell Law School’s Legal Information Institute similarly defines rulemaking as the process through which an administrative agency formulates, amends, or repeals a rule. (Cornell Wex – Rulemaking)

A rule may establish standards that apply to:

• individuals;
• businesses;
• government contractors;
• regulated industries;
• professional organizations;
• public institutions; or
• other entities within the agency’s jurisdiction.

Rules may also govern the agency’s own internal organization and procedures.

Administrative rulemaking is therefore broader than simply “making regulations.”

It is a structured legal process through which an agency develops rules that have a defined legal or administrative function.

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2. Why Do Agencies Make Rules?

The primary reason agencies make rules is that legislation often needs implementation.

Congress may establish a broad statutory objective but leave technical decisions to an agency with relevant expertise.

For example, Congress might enact legislation requiring a federal agency to establish minimum safety standards for a particular industry.

Congress may not specify:

• the exact technical specifications;
• testing procedures;
• reporting requirements;
• inspection intervals;
• recordkeeping requirements;
• certification procedures; or
• detailed compliance standards.

The agency can develop rules addressing those matters.

Rulemaking therefore allows government to move from:

general legislative principle

to

specific administrative requirement.

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3. Rulemaking Is Delegated Government Power

Administrative rulemaking is fundamentally connected to delegation.

An agency does not possess inherent legislative authority merely because it is a government institution.

Its rulemaking power ordinarily comes from:

• the Constitution;
• an enabling statute;
• another congressional statute;
• a valid delegation of authority; or
• another lawful source of governmental power.

This means that rulemaking must always begin with an important question:

Where did the agency get the authority to make this rule?

If the answer cannot be found in law, the agency may be acting beyond its authority.

That is the connection between rulemaking and the doctrine of ultra vires administrative action.

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4. Rulemaking and the Administrative State

The modern administrative state depends heavily upon rulemaking.

Administrative agencies regulate highly technical areas such as:

• aviation;
• telecommunications;
• banking;
• securities;
• environmental protection;
• public health;
• employment;
• food safety;
• pharmaceuticals;
• energy;
• transportation;
• immigration;
• taxation; and
• consumer protection.

Many of these fields involve technical questions that Congress cannot practically resolve in every detail through legislation.

Administrative rulemaking allows specialized agencies to develop detailed requirements within the framework established by Congress.

This is one of the principal reasons administrative agencies have become such an important part of modern government.

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5. Rulemaking vs. Legislation

Administrative rules can sometimes resemble legislation.

Both may establish general requirements.

Both may affect large numbers of people.

Both may create legal obligations.

But they are not the same thing.

Legislation

Legislation is enacted by a legislative body, such as Congress.

Administrative rulemaking

Rulemaking is conducted by an administrative agency under authority delegated by law.

The agency therefore operates within a hierarchy:

Constitution

↓

Statutes enacted by Congress

↓

Delegated administrative authority

↓

Administrative regulations

↓

Individual administrative decisions

The rule must remain consistent with the higher levels of this hierarchy.

An agency regulation cannot lawfully override the Constitution or contradict a controlling federal statute.

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6. Rules and Regulations

The words rule and regulation are often used interchangeably in administrative law.

A regulation is generally an administrative rule issued by an agency.

The APA defines “rule” broadly as an agency statement of general or particular applicability and future effect that is designed to implement, interpret, or prescribe law or policy, among other things.

This definition is important because not every agency document that looks like a rule has the same legal status.

An agency may issue:

• legislative rules;
• interpretive rules;
• policy statements;
• procedural rules;
• organizational rules; and
• other forms of administrative guidance.

The legal consequences can differ substantially among these categories.

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7. Legislative or Substantive Rules

A legislative rule, sometimes called a substantive rule, is generally a rule issued under delegated legislative authority that has the force and effect of law.

For example, Congress might authorize an agency to establish mandatory safety standards.

The agency then promulgates a regulation requiring covered companies to comply with specific safety requirements.

The regulation may impose legally binding obligations.

This type of rulemaking is particularly significant because it affects the legal rights and obligations of regulated parties.

Ordinarily, federal substantive rulemaking is subject to the procedural requirements of APA § 553 unless an exception applies. (Cornell Law School – Rulemaking)

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8. Interpretive Rules

Not every agency rule creates new legally binding obligations.

An interpretive rule generally explains how an agency understands an existing statute or regulation.

For example, an agency might publish guidance explaining:

“In our interpretation, the statutory term ‘reasonable safety measures’ includes the following practices.”

The agency is attempting to explain existing law rather than create entirely new legal requirements.

Interpretive rules ordinarily receive different procedural treatment from legislative rules.

Under APA § 553(b), interpretive rules are generally exempt from the ordinary notice-and-comment requirement unless another statute requires it. (Cornell Law School – 5 U.S.C. § 553)

However, the distinction between a legislative rule and an interpretive rule can sometimes become difficult.

Courts may look at the actual substance and practical effect of an agency document rather than simply accepting the agency’s label.

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9. General Statements of Policy

Agencies also issue general statements of policy.

A policy statement may announce how an agency intends to exercise its discretion.

For example:

“The agency generally intends to prioritize enforcement against repeated violations.”

This does not necessarily create a binding legal obligation.

The distinction matters because policy statements are ordinarily exempt from the APA’s standard notice-and-comment requirement under § 553(b)(A). (Cornell Law School – 5 U.S.C. § 553)

But an agency cannot necessarily transform a binding substantive rule into a policy statement merely by giving it that label.

The legal character of the document depends upon what the agency is actually doing.

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10. Procedural and Organizational Rules

Agencies may also adopt rules concerning their own:

• organization;
• procedures;
• filing requirements;
• internal processes;
• hearing procedures;
• forms;
• administrative operations; and
• methods of processing applications.

These rules can be important even when they do not directly regulate private conduct.

For example, an agency might establish:

“Applications for a particular license must be submitted electronically through the agency’s designated system.”

Such a rule concerns administrative procedure.

APA § 553 generally exempts rules concerning agency organization, procedure, or practice from ordinary notice-and-comment requirements, although another statute may require additional procedures. (Cornell Law School – 5 U.S.C. § 553)

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11. The Administrative Procedure Act

The Administrative Procedure Act is central to federal administrative rulemaking.

The APA establishes a general procedural framework for federal administrative agencies.

It governs matters including:

• rulemaking;
• adjudication;
• agency procedures;
• public participation;
• publication requirements; and
• judicial review.

Cornell’s overview of the APA explains that the Act governs how federal administrative agencies make rules and adjudicate matters. (Cornell Law School – Administrative Procedure Act)

The APA therefore provides a procedural framework within which agencies exercise delegated power.

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12. Informal Rulemaking

The most common form of federal rulemaking is informal rulemaking, often called notice-and-comment rulemaking.

Under APA § 553, an agency generally must:

1. publish notice of the proposed rulemaking;
2. identify the legal authority for the proposed rule;
3. describe the proposed rule or the issues involved;
4. provide interested persons an opportunity to submit comments;
5. consider relevant comments; and
6. issue the final rule with a concise general statement of its basis and purpose.

Cornell’s Wex identifies informal rulemaking as the most common federal rulemaking process. (Cornell Wex – Informal Rulemaking)

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13. Notice of Proposed Rulemaking

The process normally begins with a Notice of Proposed Rulemaking, commonly abbreviated as NPRM.

The agency announces that it intends to consider adopting a rule.

The notice generally explains:

• what the agency proposes;
• why it proposes the rule;
• the legal authority for the action;
• the issues involved; and
• how members of the public may participate.

The proposed rule is generally published in the Federal Register.

Cornell Wex explains that an NPRM is the formal announcement and explanation of an agency’s intent to address an issue or achieve an objective through rulemaking. (Cornell Wex – Notice of Proposed Rulemaking)

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14. Why Notice Matters

Notice serves an important rule-of-law function.

The public should know:

What is the government proposing to do?

Without meaningful notice, affected individuals and organizations would have difficulty responding intelligently.

Notice allows interested parties to:

• understand the proposal;
• identify legal problems;
• submit factual information;
• challenge assumptions;
• propose alternatives;
• identify unintended consequences; and
• argue that the agency lacks authority.

Rulemaking is therefore not supposed to be a completely private conversation between an agency and its own officials.

It is a legally structured form of public administration.

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15. Public Participation

Notice-and-comment rulemaking gives affected parties an opportunity to participate.

Interested persons may submit:

• legal arguments;
• scientific evidence;
• economic analysis;
• technical information;
• factual corrections;
• policy arguments;
• alternative proposals; and
• other relevant material.

This creates an important feedback mechanism.

The agency may discover that:

• its assumptions were incorrect;
• its proposed rule is technically unworkable;
• its economic estimates were incomplete;
• its proposal has unintended consequences; or
• a different approach would achieve the statutory objective more effectively.

Public participation can therefore improve administrative decision-making.

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16. The Comment Period

During the comment period, interested persons submit written comments concerning the proposed rule.

The agency must consider relevant material submitted during the process.

This does not mean that the agency must accept every argument.

It means that the agency must engage in the rulemaking process in a legally adequate manner.

An agency cannot simply invite public participation and then disregard the substantive issues raised by the participants.

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17. The Final Rule

After considering the relevant material, the agency may issue a final rule.

The final rule represents the agency’s completed regulatory decision.

Under APA § 553(c), the agency must incorporate in the adopted rule a concise general statement of its basis and purpose. (Cornell Law School – 5 U.S.C. § 553)

The final rule is generally published in the Federal Register.

Rules of general and permanent applicability are generally codified in the Code of Federal Regulations (CFR).

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18. The Federal Register

The Federal Register is an essential part of the federal rulemaking system.

It provides official publication of:

• proposed rules;
• final rules;
• notices;
• presidential documents; and
• other federal administrative materials.

Publication makes administrative action publicly accessible.

The basic principle is straightforward:

Government rules should not operate secretly.

Publication provides notice to the public and creates an official record of administrative action.

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19. The Code of Federal Regulations

The Code of Federal Regulations, or CFR, organizes federal administrative regulations by subject.

The Federal Register records rules as they are promulgated.

The CFR provides a more organized and continuously updated compilation of regulations that are currently in force.

The relationship can therefore be simplified as:

Proposed rule

→ Federal Register

↓

Final rule

→ Federal Register

↓

Codification

→ Code of Federal Regulations

Cornell explains that the CFR is organized into 50 titles, with federal agencies assigned chapters within those titles. (Cornell Wex – Code of Federal Regulations)

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20. Formal Rulemaking

Formal rulemaking is different from ordinary notice-and-comment rulemaking.

It is required when the governing statute requires rules to be made “on the record after opportunity for an agency hearing.”

When the formal rulemaking requirements apply, APA §§ 556 and 557 establish additional procedures.

The proceeding can resemble an adjudicatory hearing, including:

• presentation of evidence;
• a presiding official;
• procedural rulings;
• development of a formal record; and
• a decision based on that record.

Formal rulemaking is comparatively uncommon.

Cornell Wex explains that formal rulemaking is triggered when the governing statute expressly requires rulemaking to occur on the record after an opportunity for an agency hearing. (Cornell Wex – Formal Rulemaking)

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21. Informal vs. Formal Rulemaking

The distinction can be summarized simply.

Informal Rulemaking	Formal Rulemaking
Most common	Relatively uncommon
APA § 553	§§ 553, 556, 557
Notice and comments	Formal hearing procedures
Written participation	More adjudicatory process
Less elaborate record	Formal evidentiary record
Generally no trial-like hearing	Hearing required by governing statute

The important point is that formal does not simply mean “more important.”

The procedural classification depends primarily on the governing legal requirements.

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22. Exemptions from Notice-and-Comment

Not every agency rule requires ordinary notice-and-comment procedures.

APA § 553 generally exempts:

• interpretive rules;
• general statements of policy;
• rules concerning agency organization;
• rules concerning agency procedure or practice;
• certain military and foreign affairs functions; and
• certain matters involving agency management, personnel, public property, loans, grants, benefits, or contracts.

The precise scope of an exemption depends on the statute and the nature of the agency action. (Cornell Law School – 5 U.S.C. § 553)

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23. Good Cause

The APA also permits agencies in certain circumstances to dispense with ordinary notice-and-comment procedures when they make a legally sufficient good-cause finding.

Section 553(b)(B) allows this when the agency finds that notice and public procedure are:

• impracticable;
• unnecessary; or
• contrary to the public interest.

The agency must incorporate the finding and a brief statement of reasons in the rule.

Because public participation is a fundamental component of ordinary rulemaking, the good-cause exception is an important legal limitation rather than an unrestricted escape from notice-and-comment.

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24. Emergency Rulemaking

Emergency situations may sometimes justify accelerated administrative action.

For example, an agency may need to respond rapidly to:

• a serious public health threat;
• an environmental emergency;
• an immediate safety problem; or
• another urgent statutory situation.

The agency may invoke a statutory exception or the APA’s good-cause provision when legally justified.

But urgency does not automatically give an agency unlimited authority.

The agency must still identify the legal basis for its action.

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25. Rulemaking and Agency Expertise

One justification for administrative rulemaking is agency expertise.

Agencies often employ specialists in:

• economics;
• engineering;
• medicine;
• environmental science;
• finance;
• aviation;
• telecommunications;
• public health; and
• other technical fields.

Congress may therefore delegate implementation decisions to agencies with specialized knowledge.

But expertise has a limit.

Expertise can help an agency decide how to exercise lawful authority. It cannot create authority that Congress never delegated.

This principle is particularly important after Loper Bright Enterprises v. Raimondo.

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26. Rulemaking After Loper Bright

The Supreme Court’s 2024 decision in Loper Bright Enterprises v. Raimondo ended the Chevron framework under which courts had often deferred to reasonable agency interpretations of ambiguous statutes.

Courts now independently interpret statutes and determine the boundaries of delegated authority.

This matters greatly for rulemaking.

An agency cannot simply say:

“Our interpretation of the statute permits this regulation.”

The legal question remains:

Does the statute actually authorize the regulation?

Cornell’s administrative-law materials explain that after Loper Bright, courts independently interpret statutes and determine the boundaries of delegated authority. (Cornell Wex – Administrative Law)

Thus, rulemaking authority must be grounded in law rather than merely in agency interpretation.

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27. Rulemaking and the Major Questions Doctrine

The major questions doctrine is another important limitation on administrative rulemaking.

An agency may sometimes claim authority to resolve an issue of enormous economic or political significance based on broad statutory language.

The question becomes:

Did Congress clearly authorize the agency to exercise this extraordinary power?

This is especially significant when an agency attempts to adopt a rule with consequences far beyond the ordinary implementation of a regulatory statute.

The doctrine reflects the broader principle that agencies cannot assume extraordinary governmental authority merely because a statute contains general or expansive language.

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28. Rulemaking and Ultra Vires Action

This brings us directly back to the previous article.

A regulation can be ultra vires if the agency lacked authority to issue it.

For example:

Congress gives an agency authority to regulate workplace safety.

The agency adopts a rule regulating an unrelated area of private economic activity.

The agency might argue that the rule indirectly promotes workplace safety.

But the central legal question remains:

Did Congress actually authorize this regulatory power?

If not, the rule may be invalid.

Rulemaking therefore cannot be separated from the doctrine of administrative authority.

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29. Rulemaking and Separation of Powers

Administrative rulemaking also raises separation-of-powers questions.

Congress makes federal law.

The executive branch administers and enforces federal law.

Agencies operating within the executive branch may exercise delegated rulemaking authority.

But the Constitution does not allow agencies to become independent legislatures with unlimited power.

The agency must remain within the authority delegated by Congress.

This produces a recurring constitutional question:

How much policymaking authority can Congress lawfully delegate to an administrative agency?

That question leads directly to the Nondelegation Doctrine.

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30. Rulemaking and the Rule of Law

Rulemaking can strengthen the rule of law because it can replace ad hoc government decisions with publicly announced standards.

Imagine two businesses engaging in identical conduct.

If an agency has published a clear regulation, both businesses can understand the legal requirements.

This promotes:

• predictability;
• transparency;
• consistency;
• accountability; and
• equal treatment.

But poorly designed rulemaking can undermine the rule of law.

Rules that are vague, arbitrary, secretly developed, or unauthorized can create uncertainty and arbitrary governmental power.

Thus, the procedure of rulemaking is itself part of the rule-of-law framework.

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31. Rulemaking vs. Adjudication

One of the most important distinctions in administrative law is between rulemaking and adjudication.

Rulemaking

Creates, modifies, or repeals rules.

It generally establishes standards of general applicability or future effect.

Adjudication

Resolves a particular administrative matter through an order.

For example:

Agency creates a rule establishing safety requirements.

That is rulemaking.

Then:

Agency determines that Company X violated those requirements and imposes a penalty.

That is generally adjudication or enforcement.

The distinction can sometimes become complicated, but the basic difference is:

Rulemaking establishes standards; adjudication applies legal standards to particular matters.

The APA itself distinguishes rulemaking from adjudication. (Cornell Law School – 5 U.S.C. § 551)

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32. Rulemaking vs. Enforcement

Rulemaking occurs before individual enforcement decisions.

For example:

Rulemaking

Agency establishes:

“Covered facilities must maintain specified safety equipment.”

↓

Enforcement

Agency determines:

“Facility X failed to maintain the required equipment.”

↓

Adjudication or enforcement action

Agency imposes the legally authorized consequence.

This sequence demonstrates why rulemaking is so important.

It can establish the standards against which later conduct is measured.

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33. The Rulemaking Record

Rulemaking generally creates an administrative record containing materials such as:

• the proposed rule;
• supporting studies;
• economic analyses;
• public comments;
• agency responses;
• relevant evidence;
• statutory authority;
• explanations;
• and the final rule.

The record can become important if the rule is later challenged in court.

A reviewing court may examine whether the agency:

• stayed within its authority;
• followed required procedures;
• considered relevant matters;
• adequately explained its decision; and
• acted consistently with applicable law.

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34. Judicial Review of Administrative Rules

Administrative rules are not immune from judicial review.

A court may examine whether an agency:

• exceeded its statutory authority;
• violated the Constitution;
• failed to follow required procedures;
• acted arbitrarily or capriciously;
• relied on an impermissible interpretation of the law; or
• otherwise acted unlawfully.

After Loper Bright, courts independently determine questions of statutory meaning rather than automatically deferring under Chevron.

Thus, judicial review is an essential part of the rulemaking system.

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35. Why Judicial Review Matters

Administrative agencies exercise enormous practical power.

A regulation may affect:

• millions of consumers;
• entire industries;
• employers and employees;
• public institutions;
• financial markets; or
• individual rights and obligations.

Judicial review provides an external legal check.

The agency proposes and adopts the rule.

The courts determine whether the agency remained within the law.

This division reflects the broader principle of checks and balances.

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36. Petitioning an Agency for Rulemaking

The APA also provides an important participatory mechanism.

Under § 553(e), interested persons have the right to petition an agency to issue, amend, or repeal a rule. (Cornell Law School – 5 U.S.C. § 553)

This means administrative rulemaking does not always have to originate entirely inside the agency.

Members of the public can ask an agency to:

• create a new rule;
• amend an existing regulation; or
• repeal an outdated rule.

The petition mechanism provides another connection between administrative government and public participation.

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37. Negotiated Rulemaking

There are also alternative approaches to conventional rulemaking.

One example is negotiated rulemaking.

In negotiated rulemaking, representatives of interested parties may participate in a structured process intended to develop consensus concerning a proposed regulation.

Congress has established a statutory framework encouraging agencies to use negotiated rulemaking where appropriate.

The purpose is to improve the informal rulemaking process and encourage consensus where possible. (Cornell Law School – 5 U.S.C. § 561)

Negotiated rulemaking does not eliminate the agency’s legal responsibilities.

It is instead an alternative method of developing proposed regulatory approaches.

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38. Why Public Comments Matter

Public comments are not merely political expressions.

They can provide legally and factually significant information.

A commenter may demonstrate that:

• the agency misunderstood an industry practice;
• a scientific assumption is incorrect;
• the proposed rule conflicts with another statute;
• the agency lacks authority;
• the economic consequences were underestimated;
• an alternative approach is available; or
• the proposal creates unintended consequences.

For this reason, meaningful consideration of comments is an important element of rational administrative decision-making.

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39. The Final Rule Must Be Connected to the Proposal

An agency cannot necessarily propose one rule and then adopt something fundamentally different without adequate notice.

The final rule generally must represent a sufficiently logical development from the proposal so that interested persons had a meaningful opportunity to comment.

This principle protects the purpose of notice-and-comment rulemaking.

Otherwise, an agency could effectively avoid public participation by hiding the real regulatory decision until the final stage.

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40. Rulemaking and Democratic Accountability

Administrative agencies are not elected legislatures.

This creates a recurring democratic question:

Why should unelected officials be able to create rules that affect the public?

The answer lies partly in delegation and accountability.

Congress establishes the statutory framework.

Congress delegates defined authority.

The agency exercises that authority.

The public participates through rulemaking procedures.

The executive branch remains politically accountable through constitutional structures.

And courts provide judicial review.

No single institution therefore has unlimited control.

Administrative rulemaking operates within a broader system of constitutional government.

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41. Benefits of Administrative Rulemaking

Administrative rulemaking offers several advantages.

Expertise

Agencies can use specialized technical knowledge.

Flexibility

Rules can be updated more easily than comprehensive legislation.

Detail

Agencies can address technical questions that legislation cannot realistically cover.

Uniformity

Rules can establish consistent standards across a regulated field.

Transparency

Formal procedures require publication and public participation.

Responsiveness

Agencies can respond to changing circumstances within statutory authority.

Implementation

Rules translate legislative objectives into practical requirements.

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42. Risks of Administrative Rulemaking

Rulemaking also creates significant risks.

Excessive delegation

Congress may delegate broad authority.

Agency overreach

An agency may exceed its statutory authority.

Regulatory burden

Rules may impose substantial costs.

Lack of democratic accountability

Agency officials are generally not directly elected.

Bureaucratic expansion

Agencies may gradually expand their regulatory role.

Procedural complexity

Rulemaking can become extremely complicated and time-consuming.

Arbitrary decision-making

Poorly reasoned rules may produce irrational outcomes.

Administrative law therefore attempts to balance:

effective government

against

limited government.

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43. A Simple Example of Rulemaking

Imagine Congress passes the Clean Air Protection Act.

The statute instructs the Environmental Protection Agency to establish standards for emissions from certain industrial facilities.

The statute does not specify every technical limit.

The agency begins rulemaking.

Step 1 — Research

The agency studies scientific and technical information.

Step 2 — Proposed rule

The agency develops proposed emission standards.

Step 3 — Notice

The proposal is published.

Step 4 — Public participation

Businesses, environmental organizations, scientists, workers, and members of the public submit comments.

Step 5 — Review

The agency evaluates relevant comments and evidence.

Step 6 — Final rule

The agency adopts a final regulation.

Step 7 — Publication

The final rule is published.

Step 8 — Codification

The regulation is incorporated into the appropriate portion of the CFR.

Step 9 — Enforcement

The agency later determines whether regulated facilities comply.

Step 10 — Judicial review

If challenged, a court may determine whether the agency acted within its statutory authority and complied with applicable law.

This illustrates the complete regulatory cycle.

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44. A Lawyer’s Rulemaking Checklist

When analyzing an administrative rule, ask:

Authority

1. What agency issued the rule?
2. What statute authorizes the agency?
3. What provision authorizes this particular rule?
4. Has Congress expressly limited the agency’s authority?

Classification

5. Is the rule legislative or substantive?
6. Is it interpretive?
7. Is it a policy statement?
8. Is it procedural or organizational?

Procedure

9. Was an NPRM required?
10. Was adequate notice provided?
11. Was the public given an opportunity to comment?
12. Did the agency consider relevant comments?
13. Did the agency adequately explain the final rule?
14. Was a formal hearing required?
15. Does a statutory exception apply?

Substance

16. Is the rule consistent with the statute?
17. Is it consistent with the Constitution?
18. Does it exceed delegated authority?
19. Does it raise a major-questions issue?
20. Is the agency’s reasoning adequately supported?

Review

21. Is the final rule subject to judicial review?
22. Who has standing to challenge it?
23. Is there a specific statutory review mechanism?
24. What remedy is available?

This checklist provides a practical framework for analyzing most federal administrative rulemaking problems.

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45. The Complete Rulemaking Model

The entire process can be visualized as follows:

Congress

↓

Statute

↓

Delegation of authority

↓

Agency identifies regulatory problem

↓

Research and policy development

↓

Notice of Proposed Rulemaking

↓

Public participation

↓

Comments and evidence

↓

Agency consideration

↓

Final rule

↓

Federal Register

↓

Code of Federal Regulations

↓

Implementation and enforcement

↓

Judicial review

This is one of the central institutional processes of American administrative law.

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Frequently Asked Questions

What is administrative rulemaking?

Administrative rulemaking is the process through which an administrative agency formulates, amends, or repeals rules within authority delegated by law.

Who gives agencies rulemaking authority?

Federal agencies generally receive rulemaking authority from Congress through statutes. The Constitution and other applicable laws also establish limits on that authority.

What is the Administrative Procedure Act?

The Administrative Procedure Act is the principal federal statute establishing procedural requirements for federal administrative agencies, including rulemaking and adjudication.

What is notice-and-comment rulemaking?

Notice-and-comment rulemaking is the common federal process in which an agency publishes a proposed rule, allows interested persons to submit comments, considers relevant material, and then issues a final rule.

What is an NPRM?

An NPRM, or Notice of Proposed Rulemaking, is the formal publication through which an agency announces and explains a proposed rule and invites public participation.

What is the difference between a proposed rule and a final rule?

A proposed rule is an agency’s preliminary regulatory proposal. A final rule represents the agency’s completed rulemaking decision after the applicable procedures have been followed.

What is the Federal Register?

The Federal Register is the official publication in which federal agencies publish proposed and final rules and other official administrative materials.

What is the Code of Federal Regulations?

The Code of Federal Regulations, or CFR, is the organized compilation of federal regulations currently in force.

What is informal rulemaking?

Informal rulemaking is the common notice-and-comment process governed principally by APA § 553.

What is formal rulemaking?

Formal rulemaking is a more elaborate procedure involving formal hearing requirements when the governing statute requires rulemaking to occur on the record after an opportunity for an agency hearing.

Do all agency rules require notice and comment?

No. APA § 553 contains several exemptions, including exemptions generally applicable to interpretive rules, policy statements, and certain procedural and organizational rules. Other statutory or good-cause exceptions may also apply.

Can an agency make any rule it wants?

No. The agency must act within its statutory and constitutional authority.

What happens if an agency exceeds its rulemaking authority?

The rule may be challenged as unlawful or ultra vires and may be set aside by a reviewing court if the legal requirements for judicial review and relief are satisfied.

What is the difference between rulemaking and adjudication?

Rulemaking generally establishes rules or standards of future application. Adjudication generally resolves a particular administrative matter through an agency order.

Why does public participation matter?

Public participation gives affected persons an opportunity to provide information, identify problems, challenge assumptions, propose alternatives, and explain how a proposed rule may affect them.

Can an agency ignore public comments?

An agency does not have to accept every comment, but it must comply with applicable legal requirements governing consideration of relevant submissions and must provide an adequate explanation for its final decision.

What did Loper Bright change about administrative rulemaking?

Loper Bright ended Chevron deference and confirmed that courts must independently interpret statutes and determine the boundaries of delegated agency authority.

What is the relationship between rulemaking and ultra vires action?

An agency rule can be ultra vires when the agency exceeds the statutory or constitutional authority granted to it.

Can the public ask an agency to create or change a rule?

Yes. APA § 553(e) provides interested persons with a right to petition an agency for the issuance, amendment, or repeal of a rule.

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Key Takeaways

• Administrative rulemaking is the process through which agencies formulate, amend, or repeal rules.
• Rulemaking is one of the central functions of the modern administrative state.
• Agencies generally derive rulemaking authority from statutes enacted by Congress.
• Administrative rules cannot exceed the agency’s delegated authority.
• The Administrative Procedure Act provides the principal federal procedural framework for rulemaking.
• Informal rulemaking, or notice-and-comment rulemaking, is the most common form of federal rulemaking.
• The process generally begins with a Notice of Proposed Rulemaking.
• Interested persons may submit comments and relevant information.
• The agency must consider relevant material presented during the rulemaking process.
• Final rules are generally published in the Federal Register.
• Rules of general and permanent applicability are generally codified in the Code of Federal Regulations.
• Formal rulemaking involves more extensive hearing procedures and applies only when the governing statute triggers those requirements.
• Interpretive rules and policy statements ordinarily receive different procedural treatment from substantive legislative rules.
• Agencies may sometimes invoke statutory or APA exceptions to ordinary notice-and-comment procedures.
• Rulemaking differs from adjudication because rulemaking generally establishes standards while adjudication resolves particular matters.
• Agency expertise is important, but expertise cannot create statutory authority.
• After Loper Bright, courts independently determine statutory meaning and the boundaries of delegated authority.
• The major questions doctrine may limit extraordinary assertions of agency power.
• A regulation that exceeds statutory authority may constitute ultra vires administrative action.
• Judicial review provides an important check on unlawful agency rulemaking.
• Rulemaking attempts to balance two competing needs: effective administration and limited governmental power.

Conclusion

Administrative rulemaking is the mechanism through which broad legislative commands become detailed administrative requirements.

Congress establishes the legal framework.

Agencies provide much of the technical implementation.

The public participates.

The agency adopts the final rule.

The rule is published.

And courts remain available to determine whether the agency stayed within the law.

The importance of this process cannot be overstated.

Modern government could not function if Congress had to legislate every technical requirement concerning aviation safety, environmental standards, banking practices, pharmaceutical testing, workplace regulation, telecommunications, transportation, or thousands of other specialized subjects.

At the same time, administrative efficiency cannot become a justification for unlimited governmental power.

The agency’s authority must have a legal source.

Its procedures must comply with applicable law.

Its reasoning must be legally adequate.

Its regulations must remain within the boundaries established by Congress and the Constitution.

And after Loper Bright, an agency cannot simply determine the scope of its own statutory authority by adopting a preferred interpretation of an ambiguous statute.

This produces the central principle of administrative rulemaking:

Agencies may fill in the details of legislation, but they may not legislate beyond the authority that law gives them.

That principle connects administrative rulemaking to nearly every major subject in administrative law: delegation, separation of powers, the rule of law, agency discretion, the Administrative Procedure Act, judicial review, statutory interpretation, and ultra vires action.

Understanding rulemaking is therefore essential to understanding the administrative state itself.