Regulations are issued by U.S. Federal government Departments and Agencies to interpret and implement laws passed by Congress. When Congress passes a law directing an agency to perform an action, the Department may issue a regulation further interpreting the language in the law. Not all laws require regulations. Agencies generally can issue, modify, or amend regulations without seeking additional action from Congress.
For more information on when issuing regulations is necessary, please see The Administrative Procedure Act (5 U.S.C. 552).
Issuing a regulation requires several steps:
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First, the agency publishes a proposed regulation in the Federal Register for public comment, so that any member of the public can suggest changes or ask questions for clarification.
- Second, after the comment period closes, the agency considers comments and questions it received, and makes changes to the proposed regulation as it thinks necessary to address the comments and questions submitted.
- Finally, once those changes are made, the agency publishes the final regulation in the Federal Register.
The final published regulation holds the force and effect of law, and establishes requirements. If an agency wants to update or change a regulation, it must go through the steps above to do so. Some agencies might have additional steps for issuing a regulation. Agencies may issue an interim regulation or more than one proposed version of a regulation, but all agencies must go through these basic steps to publish a regulation.
All regulations are published in the Federal Register, and then codified annually in the Code of Federal Regulations or CFR. The CFR is categorized into broad subject areas, called titles. Titles are divided into parts, subparts, sections, and subsections. When referencing the CFR, usually only the title and the part or section is referenced. The format is written like this:
The annual CFR provides the most recent version of a rule as of the date the volume is published. Rules issued during the year that have not yet been codified into the CFR may be found in the Federal Register. The federal register notice also usually provides the agency’s explanation of the final regulation, its response to public comments, and any changes the agency made to the regulation from prior versions in response to comments.
If you want to see regulations that have been issued in the current year, or the agencies explanation of the rule, you should consult the federal register.
Select Agent Final Rule: Department of Health and Human Services (42 CFR Part 73) (DHHS)
This is the Department of Health and Human Services regulation implementing Title II, Subtitle A of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
Select Agent Final Rule: U.S. Department of Agriculture (7 CFR Part 331 and 9 CFR Part 121) (USDA)
This is the United States Department of Agriculture regulation implementing the Agricultural Bioterrorism Protection Act of 2002.
Organisms and Vectors (9 CFR 122)
9 CFR 122 is the United States Department of Agriculture, Animal and Plant Health Inspection Service (APHIS) regulation implementing the Animal Health Protection Act.
Export Administration Regulations (15 CFR 730-774)
15 CFR 730-774 is enforced by the Department of Commerce, Bureau of Industrial Security (BIS). The regulations set the rules for the control of export and re-export of commodities, software, and technology, including biological materials. Exporters may not export or re-export from the U.S. to certain countries and certain people biological materials and technologies that are subject to the Export Administration Regulations (EAR) without a license from BIS. BIS also maintains a list of individuals, groups, and institutions that either have a history of not complying with the EAR or for which compliance cannot be determined.
Good Laboratory Practice (GLP) Regulations (21 CFR 58)
21 CFR 58, published by the Food and Drug Administration (FDA), sets requirements for conducting and reporting of nonclinical laboratory studies, and ensure the quality and integrity of safety data. Nonclinical research is research not conducted in human beings, though it may later inform studies on human safety. The GLP Regulations cover nonclinical research with biological products, food and color additives, animal food additives, human and animal drugs, devices for human use, and electronic products.
Hazard Communication Standard (29 CFR 1910.1200)
29 CFR 1910.1200, published by the Occupational Health and Safety Administration (OSHA), requires the development and distribution of information about the identities and hazards of chemicals in the workplace. It requires comprehensive hazard communication programs, which include container labeling and other forms of warning, material safety data sheets (MSDS’s), and employee training.
Occupational Exposure to Hazardous Chemicals in the Laboratory (29 CFR 1910.1450)
29 CFR 1910.1450, published by the Occupational Health and Safety Administration, sets requirements that employers must follow to avoid exposing employees to dangerous chemicals.
Bloodborne Pathogens Standard (29 CFR 1910.1030)
29 CFR 1910.1030, published by the Occupational Safety and Health Administration, sets rules to avoid exposing people working with human body fluids to infectious microorganisms. This includes workers in diagnostic laboratories, research laboratories, hospitals, and other health care settings.
Personal Protective Equipment (29 CFR 1910.132-139)
29 CFR 1910.132-139, published by the Occupational Safety and Health Administration, sets the rules for the use of protective clothing and equipment for workers who might encounter infectious microorganisms and other hazards in the workplace.
Hazardous Waste Operations and Emergency Response (29 CFR 1910.120)
29 CFR 1910.120, published by the Occupational Health and Safety Administration, sets standards for responding to and cleaning up hazardous waste, including certain spills or accidents that happen in laboratories.
Retention of DOT Markings, Placards and Labels (29 CFR 1910.1201)
29 CFR 1910.1201, published by the Occupational Health and Safety Administration, requires employers to keep any Department of Transportation (DOT) labels or signs required by the Department of Transportation's Hazardous Materials Regulations until the packaging is cleaned of residue and vapors to remove any possible dangers.
Chapter 1: Environmental Protection Agency (40 CFR 150-189)
40 CFR 150-189 implements the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and clarifies Environmental Protection Agency requirements for licensing antimicrobial pesticides (e.g., sanitizers, disinfectants, and sterilizers).
Foreign Quarantine: Etiologic Agents, Hosts, and Vectors (42 CFR 71.54)
42 CFR 71.54 is published by the Department of Health and Human Services and focuses on preventing infectious diseases entering the US without permission. To import an infectious microorganism or to distribute an infectious microorganism after importing it, the person or institution importing must apply for a permit issued by the Centers for Disease Control and Prevention (CDC). Permits are also required to import or distribute any insects, infected animals, or other vectors of human disease.
Transportation (49 CFR 171-180)
The Research and Special Administration of the Department of Transportation, in August of 2002, revised transportation requirements for infectious materials, including regulated medical waste, to:
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adopt definitions, criteria and packaging requirements consistent with international standards;
- revise the broad exceptions for diagnostic samples and biological products;
- and allow bulk packaging options for regulated medical waste consistent with rules in international standards and Department of Transportation exemptions.
These revisions are designed to ensure safety for the transportation of infectious substances, and simplify domestic and international transportation.
Hazardous Materials Regulations (49 CFR 100-185)
These Department of Transportation Hazardous Materials Regulations include the rules for transportation and shipment of infectious materials.
Components of a Security Plan (49 CFR 172.802(a)(2) and (3))
This regulation is published by the Department of Transportation, Research and Special Administration and sets rules for companies such as FedEx who ship biological materials. Each shipping company must have a security plan in place to prevent or respond to an unauthorized person getting access to hazardous materials during transportation.
