In administrative law, rulemaking refers to the process that executive agencies use to create, or promulgate, regulations. In general, legislatures first set broad policy mandates by passing laws, then agencies create more detailed regulations through rulemaking. By bringing detailed scientific expertise to bear on policy, the rulemaking process has powered the success of some of the most notable government achievements of the 20th century. For example, science-based regulations are critical to modern programs for environmental protection, food safety, and workplace safety. However, explosive growth in regulations has fueled criticism that the rulemaking process reduces the transparency and accountability of democratic government. Administrative law (or regulatory law) is the body of law that arises from the activities of administrative agencies of government. ... An agency is a department of a local or national government responsible for the oversight and administration of a specific function, such as a customs agency or a space agency. ... A legislature is a type of representative deliberative assembly with the power to adopt laws. ... Equality and the balancing of our interests under law is symbolised by a blindfold and weighing scales For other senses of this word, see Law (disambiguation). ... Part of a scientific laboratory at the University of Cologne. ... (19th century - 20th century - 21st century - more centuries) Decades: 1900s 1910s 1920s 1930s 1940s 1950s 1960s 1970s 1980s 1990s As a means of recording the passage of time, the 20th century was that century which lasted from 1901–2000 in the sense of the Gregorian calendar (1900–1999... Environmental movement is a term often used for any social or political movement directed towards the preservation, restoration, or enhancement of the natural environment. ... Food safety is a scientific discipline describing the handling, preparation, and storage of food in ways that prevent Foodborne illness. ... The examples and perspective in this article or section may not represent a worldwide view. ... In the physical sciences, specifically in optics, a transparent physical object is one that can be seen through. ... Accountability is a concept in ethics with several meanings. ... Democracy (literally rule by the people, from the Greek δημοκρατία-demokratia demos, people, and kratos, rule) is a form of government. ...

Introduction

Legislatures rely on rulemaking to add more detailed scientific, economic, or industry expertise to a policy -- fleshing out the broader mandates of authorizing legislation. For example, typically a legislature would pass a law mandating the establishment of safe drinking water standards, then assign an agency to develop the list of contaminants and safe levels through rulemaking.

The rulemaking process has been critical to the success of some of the most notable government achievements of the 20th century, including programs for environmental protection, food safety, workplace safety, standardized financial reporting and markets, telephone relay service for the deaf, transportation safety, and others. (19th century - 20th century - 21st century - more centuries) Decades: 1900s 1910s 1920s 1930s 1940s 1950s 1960s 1970s 1980s 1990s As a means of recording the passage of time, the 20th century was that century which lasted from 1901–2000 in the sense of the Gregorian calendar (1900–1999... Environmental movement is a term often used for any social or political movement directed towards the preservation, restoration, or enhancement of the natural environment. ... Food safety is a scientific discipline describing the handling, preparation, and storage of food in ways that prevent Foodborne illness. ... The examples and perspective in this article or section may not represent a worldwide view. ... Financial supervision is government supervision of financial institutions by regulators. ... Transportation safety has steadily improved in the United States for many decades. ...

Yet, the rise of the rulemaking process itself is a matter of political controversy. Many find that obscure and complex rulemaking tends to undercut the democratic ideal of a government that is closely watched by and accountable to its citizens. Democracy (literally rule by the people, from the Greek δημοκρατία-demokratia demos, people, and kratos, rule) is a form of government. ... In the physical sciences, specifically in optics, a transparent physical object is one that can be seen through. ... Accountability is a concept in ethics with several meanings. ...

Purposes

At first blush, executive agency rulemaking appears to be an oxymoron. Executive agencies are usually charged with executing, not making, the rules. Given the scope of modern regulation, however, legislatures frequently find areas where it is impractical for lawmakers to apply the level of detail or expertise required to establish complete standards. These they delegate to agencies for follow-on rulemaking.

Common purposes of rulemaking include:

• Adding scientific expertise. For example, in the U.S., the Federal Food, Drug, and Cosmetic Act outlaws the sale of adulterated or impure drugs. The act requires that the Department of Health and Human Services promulgate regulations establishing which laboratory tests to use to test the purity of each drug.
• Adding implementation detail. Legislation on automobile fuel efficiency, for example, often delegates the development of the actual engine tests used to calculate 'city mileage' and 'highway mileage'.
• Adding industry expertise. The U.S. Clean Air Act and Clean Water Act require the Environmental Protection Agency to determine the appropriate emissions control technologies on an industry-by-industry basis.
• Adding flexibility. More detailed regulations allow for more nuanced approaches to various conditions than a single legislative standard could. Moreover, regulations tend to be more easily changed as new data or technologies emerge.
• Finding compromise. In some cases, a divided legislature can reach an agreement on a compromise legislative standard, while each side holds out hope that the implementing regulations will be more favorable to its cause.

The United States Federal Food, Drug, and Cosmetic Act (FD&C) is a set of laws passed by Congress in 1938 giving authority to the Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. ... The United States Department of Health and Human Services, often abbreviated HHS, is a Cabinet department of the United States government with the goal of protecting the health of all Americans and providing essential human services. ... Motto: (Out Of Many, One) (traditional) In God We Trust (1956 to date) Anthem: The Star-Spangled Banner Capital Washington D.C. Largest city New York City None at federal level (English de facto) Government Federal constitutional republic  - President George Walker Bush (R)  - Vice President Dick Cheney (R) Independence from... A Clean Air Act describes one of a number of pieces of legislation relating to the reduction of smog and atmospheric pollution in general. ... The Clean Water Act, 33 U.S.C.A. § 1251 et seq. ... EPA redirects here. ...

The rulemaking process

Rulemaking processes are generally designed to ensure that

• the public is informed of proposed rules before they take effect;
• the public can comment on the proposed rules and provide additional data to the agency;
• the public can access the rulemaking record and analyze the data and analysis behind a proposed rule;
• the agency analyzes and responds to the public's comments;
• the agency creates a permanent record of its analysis and the process;
• the agency's actions can be reviewed by a judge or others to ensure the correct process was followed.

For example, a typical U.S. federal rulemaking would contain these steps:

• Legislation. The U.S. Congress passes a law and assigns an agency to promulgate additional regulations.
• Advance Notice of Proposed Rulemaking. This optional step entails publishing the agency's initial analysis of the subject matter, often asking for early public input on key issue. Any data or communications regarding the upcoming rule would be made available to the public for review.
• Proposed Rule. In this step, the agency publishes the actual proposed regulatory language, a full discussion of the justification and analysis behind the rule, and the agency's response to any public comment on the advance notice.
• Public comment. Once a proposed rule is published, a public comment period begins, allowing the public to submit written comments to the agency. The agency is required to respond to each issue raised in the comments. Depending on the complexity of the rule, comment periods may last for 30 to even 180 days.
• Final Rule. Usually, the proposed rule becomes the final rule with some minor modifications. In this step, the agency publishes a full response to issues raised by public comments and an updated analysis and justification for the rule, including an analysis of any new data submitted by the public. In some cases, the agency may publish a second draft proposed rule, especially if the new draft is so different from the proposed rule that it raises new issues that have not been submitted to public comment.
• Judicial review. In some cases, members of the public or regulated parties file a lawsuit alleging that the rulemaking is improper. While courts generally offer significant deference to the agency's technical expertise, they do review closely whether the regulation exceeds the rulemaking authority granted by the authorizing legislation and whether the agency properly followed the process for public notice and comment.
• Effective date. Except in extraordinary circumstances, the rule does not become effective for some time after its initial publication to allow regulated parties to come into compliance. Some rules provide several years for compliance.
• "Hybrid" rulemaking. Not a legal term of art, but describes the kind of rulemaking performed by agencies that is somewhere between formal (with a hearing and record) and informal (with the notice and comment procedures described above).

Rules for rulemaking

Most modern rulemaking regimes have a common law tradition or a specific basic law that essentially regulates the regulators, subjecting the rulemaking process to standards of due process, transparency, and public participation. This article concerns the common-law legal system, as contrasted with the civil law legal system; for other meanings of the term, within the field of law, see common law (disambiguation). ... In United States law, adopted from English law, due process (more fully due process of law) is the principle that the government must normally respect all of a persons legal rights instead of just some or most of those legal rights when the government deprives a person of life... In administrative rulemaking, public participation refers to the process by which proposed rules are subject to public comment for a specified period of time. ...

• In the United States, the governing law for federal rulemaking is the Administrative Procedure Act of 1946. Separate states often have parallel systems.
• Commonwealth countries use a mix of common law and similar statute law.
• The European Commission has recently developed new standards pursuant to ideas laid out in a 'Whitepaper on governance.' This effort was undertaken after the Irish ‘no’ vote in 2001, addressing concerns that the public perceived the Commission’s legislative and rulemaking processes as too removed from citizen input.

The federal Administrative Procedure Act (APA) of 1946 governs the way in which administrative agencies of the United States federal government may propose and establish regulations. ... The Commonwealth of Nations (CN), usually known as the Commonwealth, is a voluntary association of 53 independent sovereign states, the majority of which are former colonies of the United Kingdom. ... This article concerns the common-law legal system, as contrasted with the civil law legal system; for other meanings of the term, within the field of law, see common law (disambiguation). ... The Statute of Grand Duchy of Lithuania A statute is a formal, written law of a country or state, written and enacted by its legislative authority, perhaps to then be ratified by the highest executive in the government, and finally published. ... The European Commission (formally the Commission of the European Communities) is the executive body of the European Union. ... 2001 (MMI) was a common year starting on Monday of the Gregorian calendar. ...

Use in private industry

Private rulemaking bodies, such as Internet, Java, and other technical communities, have adopted similar principles and frameworks to ensure fairness, transparency and thoroughness. While the mechanics vary, these efforts follow the same pattern of an open rulemaking record, public publication of proposals, and an opportunity for public comment on those proposals before they are finalized. (Even Wikipedia has followed this pattern.) In internetworking and computer network engineering, Request for Comments (RFC) documents are a series of memoranda encompassing new research, innovations, and methodologies applicable to Internet technologies. ...

Rulemaking apparatus

Public participation requires some official method for the agency to communicate to the public. Generally, agencies produce an official gazette, or periodical for publishing all rulemaking notice, such as the Federal Register. Once a rule is final, the language of the rule itself (not the supporting analysis or data) it is codified in the official body of regulations, such as the Code of Federal Regulations (CFR). The Federal Register contains most routine publications and public notices of United States government agencies. ... The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations (sometimes called administrative law) published in the Federal Register by the executive departments and agencies of the Federal Government of the United States. ...

In essence, the accountability of the rulemaking system assumes that the public actually does take note of all of the notices in the Federal Register, which can run over a hundred pages per day. In practice, many industry or public advocacy lobbyists and lawyers monitor the Federal Register Table of Contents every day by email on behalf of their constituents or clients.

Public comments are the heart of the public’s ability to participate in the rulemaking process. The agency rulemaking is usually required to consider and publish a written response to all comments. Although high-profile rulemakings may include public hearings, most rulemakings are simply noticed in the Federal Register with a call for written comments by a set deadline.

Holding agencies accountable for objective, fact-based rulemaking requires maintaining a formal record of the facts and analysis behind the rule. Agencies must assemble and make public a rulemaking record that includes all information considered as part of the rulemaking process.

These records can be enormous and can easily fill scores to hundreds of boxes. Interested parties generally must travel to an agency repository to inspect and copy this record. Interested parties frequently comb through the agency’s own data to find flaws in the agency’s reasoning. Also, interested parties’ comments on the rule then become part of this record.

Rulemaking and the courts

In the U.S., interested parties can sue to have a judge review the rulemaking process once the rule is finalized. Interested parties frequently sue the rulemaking agency, asking the court to order the agency to reconsider. Environmental groups may sue, claiming that the rule is too lax on industry. Industry groups may sue, claiming that the rule is too onerous. The historic Blue Marble photograph, which helped bring environmentalism to the public eye. ... An industry trade group is generally a public relations organization funded, founded and formed by corporations that operate in a specific industry. ...

Traditionally, courts are reluctant to step into the shoes of the technical experts and re-open the decisions made in the agency’s detailed analysis. However, courts do review whether a rulemaking meets the standards for the rulemaking process. The basis of this review by the courts may be limited to certain questions of fairness or the procedures that insure that both sides of a dispute are treated equally before any decision making occurs or that the decision is not patently unreasonable (under Canadian law) or Wednesbury unreasonableness (under British law) or similar doctrines described below. Justice is a concept involving the fair and moral treatment of all persons, especially in law. ... Decision making is the cognitive process of selecting a course of action from among multiple alternatives. ... Patently unreasonable or the patent unreasonableness test is a legal test created by common law and used in Canada by a court performing judicial review of administrative decisions. ... Wednesbury unreasonableness is a term that is used to refer to the principle enunciated in the British case of Associated Provincial Picture Houses v. ...

These powers of review of administrative decision, while often governed by statute, were originally developed out of the royal prerogative writs of English law such as the writ of mandamus and the writ of certiorari. In English law, the prerogative writs are a class of writs originally available only to the Crown, but which were later made available to the kings subjects through the courts. ... English law is a formal term of art that describes the law for the time being in force in England and Wales. ... A writ of mandamus or simply mandamus, which means we order in Latin, is the name of one of the prerogative writs and is a court order directing someone, most frequently a government official, to perform a specified act. ... This law-related article does not cite its references or sources. ...

Thus, it is not enough to simply claim that the rulemaking agency could have done a better job. Instead, under U.S. administrative law, to ask the court to order changes in a rule, a party must argue that the rule is:

Arbitrary and capricious and/or unsupported by the record. Most frequently, objectors will argue that, even if the judge is not an expert, she can tell that there is an obvious gap in the agency’s data or analysis. A court may intervene if it finds that there is no reasonable way that the agency could have drafted the rule, given the evidence in the rulemaking record. A court may send a rule back to the agency for further analysis, generally leaving the agency to decide whether to change the rule to match the existing record or to amend the record to show how they arrived at the original rule. If a court does remand a rule back to the agency, it almost always involves an additional notice and public comment period.

Exceeds statutory authority. Frequently, opponents of a rule argue that it fails to follow the instructions of the authorizing legislation. Rules can be found to exceed statutory authority if they are too strict or too lax. If a law instructs an agency to issue regulations to ban a chemical, but the agency issues a rule that instead sets levels for safe use -- or vice versa -- a court may order the agency to issue a new rule.

Bolt of out the blue. Occasionally, interested parties argue that the final rule contains provisions that were never vetted during the public comment period. A court may intervene if it finds that there was no way that the commenting public could have anticipated the new provisions and provided comment. If so, the new provisions are said to be, in a colorful legal phrase, a 'bolt of out the blue' rather than a reasonable course correction during the rulemaking process. Frequently, agencies will vet several options during the proposed rule phase to allow for comment on the full spectrum of rules under consideration.

See also

• Delegated legislation
• eRulemaking
• Legislative veto