Who's Who in Respiratory Protection Regulators

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NIOSH? OSHA? FDA? Who does what?

The government is responsible for making sure that people who work in different jobs have the right equipment to breathe safely. This has been happening for a long time, with different groups working together to make sure everything is done correctly.

There are two groups that are especially important for this: NIOSH and OSHA.

NIOSH

NIOSH tests and approves the equipment that people use to breathe at work. This agency, working under the CDC, makes sure that the equipment people use to breathe at work is safe and works well. They test and approve the equipment before it can be used by people in their jobs. This means that when people buy equipment to help them breathe at work, they can trust that it has been checked by NIOSH and will do the job it is supposed to do. NIOSH is responsible for the testing and approval of all respirators used in occupational settings.

OSHA

OSHA makes sure that the rules for using this equipment are followed and that people know how to use it properly. OSHA has a rule called the Respiratory Protection Standard. This rule says that companies have to have a plan in place to make sure their workers can breathe safely. They have to use equipment that has been approved by NIOSH and make sure their workers know how to use it. They also have to check that the equipment is working well and fix any problems they find.

FDA

Before May 2018, all surgical N95 respirators and N95 Filtering Facepiece Respirators (FFRs) used in healthcare needed to be approved by NIOSH and cleared by the FDA. After that, the FDA made a rule that certain types of these respirators no longer needed to be cleared by the FDA, but they still needed to be approved by NIOSH. In 2017, NIOSH and the FDA made a plan to work together more efficiently. This means that most surgical N95 respirators and N95 FFRs are only reviewed by NIOSH. However, if the respirator is made to prevent certain diseases or is made to kill or reduce certain microorganisms, it needs to be further reviewed by the FDA.

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