Different respirators clearly function differently, offering users two types of respiratory protection. Filtering facepiece respirators (FFR), like N95s and P100s, filter out particles like the SARS-CoV-2 virus that causes COVID-19 and the particulate matter in wildfire smoke.

Other respirators supply clean respirable air. For example, airline respirators use compressed air from a remote source, and a self-contained breathing apparatus (SCBA) has its own air supply.

N95 respirators filter at least 95% of airborne particles but are not resistant to oil; other particulate FFRs approved by the National Institute of Occupational Safety and Health (NIOSH) include:

  • Surgical N95s, NIOSH-approved N95 respirators that meet Food and Drug Administration (FDA) criteria for use as surgical masks;
  • N99s, which filter at least 99% of airborne particles that are not resistant to oil;
  • N100s, which filter at least 99.97% of airborne particles that are not resistant to oil;
  • R95s, which filter at least 95% of airborne particles and are somewhat resistant to oil;
  • P95s, which filter at least 95% of airborne particles and are strongly resistant to oil;
  • P99s, which filter at least 99% of airborne particles and are strongly resistant to oil; and
  • P100s, which filter at least 99.97% of airborne particles and are strongly resistant to oil.

Like other personal protective equipment (PPE), respirators are used as a hazard control of last resort. Elimination sits atop the hierarchy of occupational hazard controls and is the most effective control available to you. The hierarchy of controls culminates in PPE like respirators. You need to provide your employees with respirators or other PPE when all other controls—elimination, substitution, engineering controls, and administrative controls—fail to reduce hazardous exposures to safe levels.

While the Occupational Safety and Health Administration (OSHA) regulates and enforces employer compliance with respiratory protection program requirements, NIOSH tests and approves respirators and provides guidance for their use in occupational settings.

The FDA sets requirements for surgical N95s under its medical device authority, and NIOSH tests and approves surgical N95s under a memorandum of understanding (MOU) with the FDA.

COVID-19 and the next pandemic

Beginning in spring 2020, concerns about the spread of COVID-19 led to high demand for N95 respirators. In fact, the COVID-19 pandemic led to 20- to 40-time increases in demand for PPE, according to one manufacturer.

PPE manufacturers reported that increased worldwide demand due to the outbreak, coupled with decreases in exports from countries like China, India, and Taiwan, resulted in challenges in meeting the demand for respirators.

At the time, OSHA took several steps to address the breakdown in the respirator supply chain, including issuing temporary guidance concerning its enforcement of the respiratory protection standard’s annual respirator fit-testing requirements. The agency also directed its field offices to exercise discretion in citing employers for violations of the annual fit-testing requirement if the employers met certain conditions, as it accepted that employers would need to postpone annual fit testing to maximize available supplies of FFRs.

OSHA also temporarily allowed the use of foreign-made respirators that were not NIOSH-approved and temporarily allowed extended reuse and decontamination of limited supplies of disposable FFRs.

Supplies of N95s and other FFRs have been reestablished, and OSHA’s early pandemic policies have expired or been canceled.

Now, the Centers for Disease Control and Prevention (CDC) is tracking a surge in COVID-19 infections caused by Omicron variants of the SARS-CoV-2 virus. Variants of concern include B.1.1.529, BA.1, BA.1.1, BA.2, BA.3, BA.4, and BA.5.

A group of public health experts, including some who were on President Joe Biden’s transition COVID-19 advisory panel, released a report this spring calling on the CDC, NIOSH, and OSHA to take steps to respond to future surges in infection. The group recommended that OSHA establish federal standards for workplace ventilation, appropriate PPE, and physical distancing.

Specific recommendations about OSHA’s regulation and enforcement of respiratory protection included:

  • Requiring that employers provide high-quality face coverings—N95 respirators or equivalent—to workers in high-risk environments;
  • Issuing an enforcement directive clarifying that the agency’s current respiratory protection standard requires employers in high-risk industries to provide at least N95 respirators in situations in which the risk of airborne infectious disease transmission is high or where indoor working conditions are crowded or public-facing; and
  • Issuing an enforcement directive enabling employers to require N95 face covering use by workers not usually covered by the respiratory protection standard without triggering the need for full respiratory protection standard compliance and emphasizing that employer mitigation measures must go beyond providing respirators, implementing a layered approach to reducing workplace exposure risk.

The group also called for OSHA to issue a permanent COVID-19 standard for health care with respiratory protection and ventilation requirements. OSHA is working on a rulemaking based on its June 21, 2021, healthcare COVID-19 emergency temporary standard (ETS). The expired ETS included requirements for a “mini-respiratory protection program.”

Another report from the National Academies of Sciences, Engineering, and Medicine determined that the COVID-19 pandemic revealed shortcomings in the current U.S. regulatory scheme for respiratory protection. The National Academies’ analysis pointed out that many independent contractors and self-employed and “gig” workers are not considered employees or employers and are not covered by OSHA regulations. The report also identified other gaps in respiratory protection, including:

  • Although the public may use face coverings, medical masks, and respirators, none has been approved by any federal agency for use other than in occupational settings.
  • There is no formal system of guidance and education for the public on when and how to use a respiratory protective device and which devices individuals, including children, should wear.
  • A lack of guidance and widespread misinformation contributed to confusion and disagreement during the COVID-19 pandemic regarding the need to use protective devices and the level of protection that different kinds of devices provided.
  • The COVID-19 pandemic also exposed problems in the existing supply chains to meet the demands for respiratory protective devices during public health emergencies.

The report also noted that South Korea responded aggressively to COVID-19 because of lessons learned during the 2015 Middle East respiratory syndrome coronavirus (MERS-CoV) outbreak.

With supply chains reestablished, the most pressing question for employers, manufacturers, and suppliers is: “Are we ready for the next pandemic?” NIOSH recently released a tool for predicting N95 respirator needs in non-healthcare workplaces. The spreadsheet-based tool is available in a supplement to NIOSH’s article in the journal Health Security.

NIOSH researchers identified the number of workers employed in essential non-healthcare workplaces and estimated that about 85 million essential non-healthcare workers could need N95 respirators during another pandemic spread by an aerosol like the SARS-CoV-2 virus.

They looked at possible scenarios for three levels of N95 respirator use—one N95 respirator per week, two N95 respirators per week, and five N95 respirators per week—for pandemics lasting 15 and 40 weeks.

Where one N95 is needed each week over a 15-week pandemic, researchers estimated that essential non-healthcare employees would need about 1.3 billion N95 respirators. In the worst-case scenario—five N95s a week over a 40-week-long pandemic—17 billion N95s would be needed.

Respiratory protection compliance

Under OSHA’s respiratory protection standard (29 Code of Federal Regulations (CFR) §1910.134), you must establish a written respiratory protection program and provide respirators at no cost to your employees. You also must designate a qualified person to administer the program.

Respirator selection for your program depends on the respiratory hazards present at the facility or worksites. Some standards require a specific respirator type—for instance, the standard for asbestos requires a tight-fitting, powered air-purifying respirator (PAPR).

If your employees are exposed to an atmosphere considered immediately dangerous to life or health (IDLH), you must provide them with a NIOSH-approved full facepiece, pressure-demand SCBA or a combination full facepiece pressure-demand, supplied-air respirator (SAR) with an auxiliary self-contained air supply.

In non-IDLH atmospheres, the respirators you provide must meet or exceed the required levels of protection—the assigned protection factor (APF)—set out in Table 1 of the respiratory protection standard.

Moreover, you must have your employees evaluated by a physician or another licensed healthcare professional before allowing them to wear respirators to determine whether they are physically capable of wearing a respirator. The evaluation involves a questionnaire and a medical examination. A medical professional should also provide you with written recommendations regarding your employees’ ability to use a respirator.

Respirators then must be fit tested before workplace use. A negative- or positive-pressure tight-fitting facepiece respirator must pass a qualitative fit test (QLFT) or quantitative fit test (QNFT). Annual fit tests are required after the initial fit test, as are additional fit tests when an employee reports physical changes like facial scarring, dental changes, or change in body weight or when physical changes might affect respirator fit.

Facial hair can also interfere with the face-to-facepiece seal, resulting in leakage. Employees with certain types of facial hair, such as full beards, may not wear tight-fitting respirators because facial hair can prevent a respirator facepiece from sealing to the face.

Additionally, your employees must perform a user seal check each time they use tight-fitting respirators, following OSHA’s mandatory procedure or an effective procedure specified by the respirator’s manufacturer.

Furthermore, your program must include cleaning and disinfection of nondisposable respirators, following either OSHA’s mandatory procedure or procedures specified by the respirators’ manufacturer.

Maintenance must be performed as often as necessary and before a respirator is worn by a different individual. You also must perform maintenance after nondisposable respirators are used for fit testing or training and after each use of emergency-use respirators.

There are training requirements in the respiratory protection program standard.

OSHA requires initial respirator training before the first workplace use of a respirator and annual retraining. Training must cover:

  • General requirements of OSHA’s standard;
  • The capabilities and limitations of a respirator, as well as why a respirator is necessary and how improper fit, maintenance, or use can compromise the protective value of a respirator;
  • Respirator use in emergency situations;
  • How to inspect, put on and check seals, use, and remove a respirator;
  • Procedures for maintenance and storage; and
  • Recognition of medical signs and symptoms that may limit or prevent effective respirator use.

NIOSH’s Respiratory Protection Week 2022 is September 6–9; Respiratory Protection Week began in 2012 as N95 Day and expanded in 2019 to a full week focusing on all types of respiratory protection.

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