How’s your respiratory protection compliance? Last year, the Occupational Safety and Health Administration (OSHA) allowed inspectors to exercise enforcement discretion, especially in enforcing the agency’s annual fit-testing requirement, in response to respirator shortages. All those discretion directives have since been withdrawn. The time is now to check all components of your written respiratory protection program, as well as all aspects of your program implementation.

OSHA’s respiratory protection standard (29 CFR §1910.134) is the agency’s third most frequently cited standard, having been cited 2,649 times in fiscal year 2020.

Pandemic disruptions

Disposable filtering facepiece respirators (FFR) like N95s were in short supply in the first several months of the COVID-19 pandemic. In fact, the COVID-19 pandemic led to 20- to 40-time increases in demand for personal protective equipment (PPE), according to a white paper by manufacturer 3M. High demand for respiratory protection created opportunities for fraud and counterfeit products. 3M reported a rise in fraud and counterfeiting at the start of the COVID-19 pandemic.

To mitigate FFR shortages, OSHA and the Food and Drug Administration (FDA) authorized the use of foreign-made FFRs not approved by the National Institute for Occupational Safety and Health (NIOSH). The FDA and OSHA also allowed the decontamination and reuse of FFRs. Officials have since ended their capacity crisis strategies.

3M alone tripled its production of respirators from 2019, according to the company, producing 2 billion respirators globally in 2020. Honeywell expanded N95 production last year, including production at its Smithfield, Rhode Island, facility, which had been dedicated to producing the company’s UVEX-branded safety glasses, safety goggles, and face shields. By December 2020, Honeywell delivered 225 million N95 respirators and disposable, surgical face masks in a single month.

NIOSH’s National Personal Protective Technology Laboratory (NPPTL) performed assessments of the nonapproved respirators and found a wide variation in filtration efficiency. Most of the FFRs tested had an ear-loop design, likely limiting the ability to achieve proper fit. NIOSH-approved N95s typically have head bands. With the removal of capacity crisis strategies, the NPPTL has discontinued its assessment of nonapproved respirators.

During the 2020 shortages of respiratory protection supplies, OSHA authorized temporary enforcement discretion to conserve supplies of N95 FFRs. The agency has since lifted its authorization for enforcement discretion. OSHA expects employers to comply with all requirements under the respiratory protection standard, including medical evaluation, initial and annual fit testing, and training.

The respiratory protection standard requires a written respiratory protection program, with worksite-specific procedures and program elements in support of respirator use. The program must be administered by a trained program administrator. Other requirements include:

  • Medical evaluations to determine employees’ ability to use respirators;
  • The use of tight-fitting respirators to ensure a facepiece seal and fit testing following OSHA-approved protocols;
  • Maintenance and care, cleaning and disinfection, and storage of reusable respirators;
  • Employee training and information that includes training in performing a user seal check each time a respirator is used; and
  • Records of medical evaluation and fit testing.

OSHA’s COVID-19 emergency temporary standard (ETS) for healthcare and healthcare support services includes a “Mini Respiratory Protection Program” requirement, which allows voluntary use of respirators. The mini-respiratory protection program does not require medical evaluation for voluntary respirator use; however, an employer may not provide a respirator to an employee who has previously been determined to be medically unfit to wear a respirator.

The AIHA (formerly the American Industrial Hygiene Association) expressed concerns about the federal ETS in a letter to OSHA, suggesting that the agency remove the mini-respiratory protection program provisions from the emergency rule. The group argued against allowing the voluntary use of respirators outside a formal program under the permanent respiratory protection standard.

Respiratory protection’s role

Like all other PPE, respiratory protection is the precaution of last resort when all other controls are unable to limit exposures. The industrial hygiene “hierarchy of controls” is elimination, or the physical removal of a hazard; substitution, or replacing a hazard; engineering controls like barriers with local exhaust ventilation; administrative controls or work practices; and then PPE.

Respiratory protection is used when employees are still exposed to a respiratory hazard despite all other precautions.

OSHA’s standard requires employers to establish a written respiratory protection program and provide respirators at no cost to employees. A qualified person must administer the program. OSHA’s Small Entity Compliance Guide for the Respiratory Protection Standard offers guidance for small and midsize businesses and includes a sample program.

Respirator selection depends on the respiratory hazard present at the workplace or site. For an atmosphere considered immediately dangerous to life or health (IDLH), employees must be provided with NIOSH-approved full facepiece, pressure-demand, self-contained breathing apparatus (SCBA) or a combination full facepiece pressure-demand, supplied-air respirator (SAR) with auxiliary self-contained air supply. In non-IDLH atmospheres, the respirator must meet or exceed the required levels of protection—the assigned protection factor (APF)—set out in Table 1 of the standard.

However, a specific standard like the one for asbestos (§1910.1001) may require a specific respirator type. The asbestos standard requires the use of a tight-fitting, powered air-purifying respirator (PAPR).

Before you allow employees to wear respirators, they must be evaluated by a physician or another licensed healthcare professional to determine whether they’re physically capable of wearing a respirator. The evaluation includes a questionnaire and a medical examination. You will need written recommendations from a medical professional regarding your employees’ ability to use a respirator.

Respirators must be fit tested on employees before use. A negative- or positive-pressure tight-fitting facepiece respirator must pass a qualitative fit test (QLFT) or quantitative fit test (QNFT). After an initial fit test, additional annual fit tests are required, 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 that might affect respirator fit can be observed.

Employees with facial hair may not wear tight-fitting respirators because facial hair can interfere with the face-to-facepiece seal. NIOSH’s “Facial Hairstyles and Filtering Facepiece Respirators” infographic is one of its most popular resources and illustrates facial hairstyles such as handlebar or pencil mustaches that do not interfere with respirator fit and styles like stubble or full beards that do.

Leakage results because facial hair can prevent a respirator facepiece from sealing to the face. Each time employees use a tight-fitting respirator, they must perform a user seal check following OSHA’s mandatory procedure or an equally effective procedure specified by the respirator’s manufacturer.

Non-disposable respirators must be cleaned and disinfected according to OSHA’s mandatory procedure or equally effective procedures specified by the respirators’ manufacturer. Maintenance must be performed as often as necessary and before a respirator is worn by a different individual. Maintenance also must be performed after respirators are used for fit testing or training and after each use of emergency-use respirators.

OSHA requires initial respirator training before the first workplace use of a respirator, as well as annual retraining. Training sessions must cover:

  • Why a respirator is necessary and how improper fit, maintenance, or use can compromise the protective value of a respirator;
  • Capabilities and limitations 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;
  • Recognition of medical signs and symptoms that may limit or prevent effective respirator use; and
  • General requirements of OSHA’s standard.

Annual retraining must cover any changes in working conditions or types of respirators used.

You must keep a written copy of your current respiratory protection program and records of employee medical evaluations and fit testing. OSHA also requires evaluations of your respiratory protection program to ensure proper implementation of the program and proper employee use of respirators.

FDA, NIOSH, OSHA regulatory roles

In addition to OSHA’s respiratory protection standard, the regulation of respirators and surgical masks, used for infection source control, falls into the following framework:

  • NIOSH evaluates and approves all respirators used in the United States.
  • The FDA regulates surgical masks and respirators used in healthcare facilities under its medical device authority.
  • NIOSH tests N95 respirators intended for healthcare use under a memorandum of understanding with the FDA and ensures that such respirators meet additional FDA test requirements.

In addition to N95 respirators that filter at least 95% of airborne particles but are not resistant to oil, other NIOSH-approved particulate FFRs include:

  • Surgical N95s, or NIOSH-approved N95 respirators that meet FDA criteria for use as surgical masks;
  • N99s, which filter at least 99% of airborne particles but are not resistant to oil;
  • N100s, which filter at least 99.97% of airborne particles but 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.

Most N95 respirators in the United States are manufactured and sold for construction and industrial use rather than health care. At the beginning of the COVID-19 pandemic, the FDA allowed the use of nonhealthcare N95s in response to respirator shortages. Such industrial respirators are not tested to meet FDA requirements for healthcare use.

In addition to testing FFRs like N95 respirators, NIOSH also tests and approves air-purifying and air-supplied respirators, including those for chemical, biological, radiological, and nuclear protection, and closed-circuit escape respirators. NIOSH maintains a Certified Equipment List of respirators tested and approved by the NPPTL.

For Respiratory Protection Week, which is September 7–10, the NPPTL has planned a number of events, including a webinar on the future of respiratory protection and PPE covering emerging protective equipment technology and the use of PPE in nontraditional settings, as well as meeting the needs of historically underserved PPE user groups, and a webinar about the roles of the FDA, NIOSH, and OSHA in respiratory protection, taking a deeper dive into respiratory protection authority and defining each agency’s role.

Now that PPE manufacturers have fixed supply chain problems, OSHA has rescinded its enforcement discretion directives. When agency inspectors determine the presence of a workplace respiratory hazard, they will check for a written respiratory protection program and proper implementation of all required program elements like medical evaluation, fit testing, cleaning and maintenance, training, and recordkeeping.

For more information or assistance with your Environmental and Health & Safety regulatory compliance needs, contact Ralph Carito at Total Environmental & Safety, LLC (Total) at rcarito@TotalEnviron.com or 908-442-8599.

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