This section provides a brief explanation of the branches of the US federal government, as well as the US legislative process from the initiation of legislation through implementation of regulations.
The US federal government is divided into three branches, as designated in the Constitution of the United States: Legislative, Executive, and Judicial.
The US Congress is the legislative branch and makes the laws. It considers two types of legislation: authorization bills that create or modify government programs and appropriations bills that fund those programs.
Congress consists of two bodies. One is the House of Representatives, whose 435 voting members each represent a Congressional district. The other is the Senate, whose 100 members each represent a state. Each state has a number of Representatives in proportion to its population and two Senators.
Bills are drafted, introduced into one or both chambers of Congress, deliberated upon, and voted on. Bills passed by both the House and Senate go to the President for consideration.
The President acts on legislation passed by the Congress, choosing either to sign a bill into law or veto it. The latter is subject to Congressional override.
The President also is the nation’s chief executive and, as such, runs the executive branch of the federal government. As chief executive, the President can influence the functioning of government departments through, for example, his or her choice of officials to run them and the issuance of executive orders.
The executive branch of the federal government enforces the laws. It consists of the President, Vice President, Cabinet, executive departments, independent agencies, and other entities.
One of the executive branch’s main functions is to implement the laws passed by the Congress and signed by the president. The agencies designated as regulatory agencies carry out this responsibility by:
The federal court system, including the Supreme Court, constitutes the nation’s judicial branch, which interprets the meaning of laws.
Many of the nation’s federal laws governing toxicity testing and the use of animals and alternatives are civil rather than criminal laws.
Federal bills can be drafted by anyone but ultimately must be introduced into Congress by one or more of its members (“sponsors”) in order to be considered. Every bill introduced into the Congress is assigned a Public Law (P.L.) number. For example, P.L. 103-43 was passed during the 103rd session of Congress as the 43rd bill of the session. Public laws, other legislative information, and more information on how laws are made can be found at CONGRESS.GOV (replacing the THOMAS website).
Legislation passed by Congress can become law in two ways: after it is signed by the President or after Congress overrides the President’s veto.
After enactment, a new law is incorporated into the United States Code (USC), which organizes laws into titles (there are currently 50) and then sections within each title. For example P.L. 97-414, 21USC sec. 360cc corresponds to Title 21, section 360. Food and drug laws are under Title 21.
Congress authorizes US regulatory agencies to implement new laws by developing regulations, also known as rules. The process of developing regulations is called rulemaking. The agency responsible for implementing a law is the one that promulgates the implementing regulations.
Federal regulations are organized into the Code of Federal Regulations (CFR) (not to be confused with the USC).
The Federal Register is the federal government’s daily publication of proposed regulations and enacted laws. Agencies such as the EPA and FDA propose a regulation, publish a notice in the Federal Register, and thereby provide the public with the opportunity to comment on the proposed regulation. After considering the comments, the agency publishes the final rule in the Federal Register. The regulation then becomes part of the CFR.
Agencies also publish guidelines. However, unlike regulations, guidelines are not enforceable.
Agencies must abide by any government-wide laws and executive orders applicable to the development of regulations. These laws include the Administrative Procedure Act, the Regulatory Flexibility Act, the Paperwork Reduction Act, the National Technology Transfer and Advancement Act, and the Congressional Review Act.
Code of Federal Regulations (CFR): “The codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government”
Electronic Code of Federal Regulations (e-CFR): “Currently updated version of the Code of Federal Regulations (CFR)…not an official legal edition of the CFR”
The Federal Register (FR): “The official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents”
List of CFR Sections Affected (LSA): “Lists proposed, new, and amended Federal regulations that have been published in the Federal Register since the most recent revision date of a CFR title”
Regulations.gov: US government website for locating, viewing, and commenting on regulations and other actions for all federal agencies
THOMAS (The Library of Congress): Search public laws and other legislative information
THOMAS website: “How our laws are made”
The Unified Agenda: “Summarizes the rules and proposed rules that each Federal agency expects to issue during the next six months”
United States Code (USC): organization of US laws by subject matter