Overall information from 1 to 10 about NIOSH

What is NIOSH?


The Occupational Safety and Health Act of 1970 external icon established NIOSH as a research agency focused on the study of worker safety and health, and empowering employers and workers to create safe and healthy workplaces. NIOSH is part of the U.S. Centers for Disease Control and Prevention, in the U.S. Department of Health and Human Services.

It has the mandate to assure “every man and woman in the Nation safe and healthful working conditions and to preserve our human resources.” NIOSH has more than 1,300 employees from a diverse set of fields including epidemiology, medicine, nursing, industrial hygiene, safety, psychology, chemistry, statistics, economics, and many branches of engineering.

  • Milestones in NIOSH History
  • Diversity in NIOSH

Amendments to Respirator Certification Fees

The Department of Health and Human Services (HHS) has revised the fee structure established in 42 CFR Part 84 (Part 84), used by the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC) to charge respirator manufacturers for the examination, inspection, and testing of respirators which are submitted to NIOSH for the purpose of creating or modifying a certificate of approval.

NIOSH Regulations

The National Institute for Occupational Safety and Health is responsible for conducting research and making recommendations for the prevention of work-related injury and illness. Although NIOSH is generally characterized as a non-regulatory agency, guidance, and recommendations issued by NIOSH are often used by other agencies responsible for developing and enforcing workplace safety and health regulations.

It is also directly responsible for several regulations. These regulations mostly outline procedures and requirements for specific health and safety-related matters involving a particular industry or set forth rules to follow in administering programs assigned to the Institute. The regulations include rules regarding the following:

  • The Coal Workers Health Surveillance Program which describes x-ray screening of underground coal miners, autopsies, and operation of the B-reader program for classifying pneumoconiosis;
  • Grants and educational training programs
  • Implementation of HHS responsibilities under the Energy Employees Occupational Illness and Compensation Program Act (EEOICPA);
  • Approval of respiratory protective equipment;
  • Conducting investigations at places of employment for the Health Hazard Evaluation (HHE) program and for occupational safety and health research; and
  • Implementation of the World Trade Center Health Program.
    The regulations are found in the following parts of the Code of Federal Regulations (CFR) and are linked below.

NIOSH-Approved Respirators

What is a Respirator?

A respirator is a personal protective device that is worn on the face, covers at least the nose and mouth, and is used to reduce the wearer’s risk of inhaling hazardous airborne particles (including dust particles and infectious agents), gases or vapors. Respirators should only be used as a “last line of defense” in the Hierarchy of Controls when engineering and administrative controls are not feasible or are in the process of being put in place.

Respirators protect the user in two basic ways. The first type of respirator removes contaminants from the air, and are called air-purifying respirators (APRs). APRs include particulate respirators, which filter out airborne particles, and “gas masks,” which filter out chemicals and gases. Other respirators protect by supplying clean respirable air from another source. Air-Supplying Respirators (ASRs) comprise this category of respirators.

They include airline respirators, which use compressed air from a remote source; and self-contained breathing apparatus (SCBA), which include their own air supply.

View the OSHA Respirator Types Videoexternal icon

The classification of particulate respirators can be further subdivided into three categories:

  • Particulate filtering facepiece respirators – Sometimes referred to as disposable respirators because the entire respirator is discarded when it becomes unsuitable for further use due to considerations of hygiene, excessive resistance, or physical damage. These are also commonly referred to as “N95s.”
  • Elastomeric respirators –Sometimes referred to as reusable respirators because the facepiece is cleaned and reused but the filter cartridges are discarded and replaced when they become unsuitable for further use.
  • Powered air-purifying respirators (PAPRs) – A battery-powered blower moves the airflow through the filters.

What is a NIOSH-Approved N95 Filtering Facepiece Respirator?

Even though you see N95 on the package, it still may not be the right kind of respirator, or one that meets NIOSH approval requirements.

You may have heard that a NIOSH-approved N95 respirator is recommended for your respiratory protection needs. This is one of the most commonly used respirators. Again, even though you see N95 on the package, it still may not be the right kind of respirator, or one that meets NIOSH approval requirements.

Filtering Facepiece respirators are divided into various classes based on their filtration capabilities. “N95 respirator” is a term used to describe the class of respirators which use N95 filters to remove particles from the air that is breathed through them.

The NIOSH respirator approval regulation defines the term N95 to refer to a filter class that removes at least 95% of airborne particles during “worst-case” testing using a “most-penetrating” sized particle during NIOSH testing. Filters meeting the criteria are given a 95 rating. Many filtering facepiece respirators have an N95 class filter and those meeting this filtration performance is often referred to simply as N95 respirators.

Filtering Facepiece Respirator (FFR) Labels

Individual filtering facepiece respirators are required to have the following markings:

  • Name of approval holder/manufacturer business name, a registered trademark, or an easily understood abbreviation of the applicant/approval holder’s business name as recognized by NIOSH. When applicable, the name of the entity to which the FFR has been private labeled by the approval holder may replace the approval holder’s business name, registered trademark, or abbreviation of the approval holder’s business name as recognized by NIOSH.
  • Lable in block letters or the NIOSH logo.
  •  Testing and Certification approval number, e.g., TC-84A-XXXX.
  • Filter series and filter efficiency level, e.g., N95, N99, N100, R95, P95, P99, P100.
  • Model number or part number: The approval holder’s respirator model number or part number, represented by a series of numbers or alphanumeric markings, e.g., 8577 or 8577A.

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