Sign In

An official website of the United States government

U.S. Department of Health & Human Services

Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( A locked padlock ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Law and Policy

S3: Science Safety Security

Biorisk Management 

The United States (US) Constitution defines the three branches of the US Federal Government and their powers, as well as the powers that are reserved to the States and to individuals. Under the Constitution, the Federal government of the United States is divided into three parts:

  • The Legislative Branch, or Congress, which is comprised of the House of Representatives and the Senate
  • The Executive Branch, which includes the Executive Office of the President and the Federal agencies
  • The Judiciary Branch, which includes the Supreme Court and Federal Appellate and District Courts

Laws are written and passed by the Legislative Branch, signed and implemented by the Executive Branch, and can be challenged through the Judiciary Branch. The President, as head of the Executive Branch, holds the power to direct the activities of Federal Agencies as long as instructions do not come in conflict with decisions of other branches.

The many types of legal instruments in the US are a product of this three branch system. The types of legal and policy instruments discussed on this website generally come from the Legislative and Executive Branches of government.

The most common types of legal instruments discussed are laws and regulations. Laws are passed by both branches of Congress and signed by the President. Laws establish requirements or prohibitions. Regulations are published by executive branch agencies to clarify their interpretation of a law and how a law will be implemented. Regulations also state requirements or prohibitions.

Some agencies also publish guidance or other policy statements, which further clarify how an agency understands and implements existing laws and regulations. Guidance and other policy statements describe suggested or recommended actions. Guidance and policy statements do not provide mandatory requirements unless they are incorporated into a regulation or mandated under terms and conditions of an agreement, such as a funding agreement.

All laws must be consistent with the authorities provided under the Constitution, and all regulations, guidance, and policies must be consistent with laws. In addition there are several measures the President can use to direct the actions of the Federal government. The most common types are Executive Orders and Presidential Directives. These Presidential measures state mandatory actions for federal agencies, and must be consistent with the Constitution and laws enacted by Congress.

As a nation, the U.S. also enters into treaties, which govern international behavior or are international agreements on specific topics. In the US, a treaty must be signed by the President or an Ambassador and also ratified by two-thirds of the Senate. Once signed and ratified, the terms of a treaty are also mandatory. In effect, the US agrees to be bound by the terms of the treaty.

All of these documents can be placed in a basic hierarchy. In practice, these relationships can be somewhat more complex, but the chart below shows the basic relationships.

Law Hierarchy 

Topics in Law & Policy