In response to a shortage of disposable N95 filtering facepiece respirators caused by the coronavirus (COVID-19) pandemic, the Occupational Safety and Health Administration (OSHA) has issued enforcement guidance that allows its Compliance Safety and Health Officers (CSHOs) to use discretion when enforcing certain respiratory protection rules.
The guidance encourages employers to identify any changes they can make to decrease their need for disposable N95 filtering facepiece respirators (N95s). If respiratory protection must be used, employers may consider using alternative classes of respirators that provide equal or greater protection compared to an N95, such as non-disposable, elastomeric respirators or powered, air-purifying respirators.
When these alternatives are not available, or where their use creates additional safety or health hazards, the guidance allows CSHOs to permit the extended use or reuse of N95s, or use of N95s that were approved but have passed the manufacturer’s recommended shelf life (expired). This guidance applies in all industries, including those with workplaces in which workers are exposed to COVID-19. It takes effect immediately and will remain in effect until further notice.
This Compliance Bulletin provides the text of the guidance.
Action Steps
Employers should become familiar with OSHA’s guidance and review their engineering controls, work practices and administrative controls to identify any changes they can make to decrease the need for N95 masks.
Highlights
Employers May Use
Alternatives to N95 Masks OSHA encourages employers to use alternatives to N95 respirators to address a shortage caused by COVID- 19.
Additional Uses of N95 Masks May be Allowed
OSHA may allow extended use of N95s, reuse of N95s, and use of expired N95s under certain circumstances.
Important Dates
April 3, 2020
OSHA issued guidance on respiratory protection standards during the COVID-19 pandemic. The guidance became effective immediately and remains in effect until further notice.
OSHA’s Enforcement Guidance for Respiratory Protection and the N95 Shortage Due to the COVID-19 Pandemic
This OSHA memorandum provides interim guidance to Compliance Safety and Health Officers (CSHOs) for enforcing the Respiratory Protection standard, 29 CFR § 1910.134, and certain other health standards, with regard to supply shortages of disposable N95 filtering facepiece respirators. Specifically, it outlines enforcement discretion to permit the extended use and reuse of respirators, as well as the use of respirators that are beyond their manufacturer’s recommended shelf life (sometimes referred to as “expired”).
This guidance applies in all industries, including workplaces in which:
- Health care personnel (HCP) are exposed to patients or others with suspected or confirmed COVID-19 and other sources of SARS-CoV-2 (the virus that causes COVID-19); and
- Protection of workers exposed to other respiratory hazards is impacted by the shortage resulting from the response to the COVID-19 pandemic. These workplace respiratory hazards may be covered by one or more substance-specific health standards.
A previous memorandum, Temporary Enforcement Guidance – Healthcare Respiratory Protection Annual Fit-Testing for N95 Filtering Facepieces During the COVID-19 Outbreak, issued on March 14, 2020, provided temporary guidance for 29 CFR § 1910.134, regarding required annual fit testing of HCP. This memorandum provides additional guidance on enforcing OSHA’s respirator standard for all workers, including HCP. In light of the essential need for adequate supplies of respirators, this memorandum will take effect immediately and remain in effect until further notice.
This guidance is intended to be time-limited to the current public health crisis. Please frequently check OSHA’s coronavirus webpage for updates.
Background
The COVID-19 outbreak, which the World Health Organization recently declared a global pandemic, has created an increased demand for N95 filtering facepiece respirators, limiting availability for use in protecting workers in health care and emergency response from exposure to the virus. As a result, President Trump directed the secretary of labor to “take all appropriate and necessary steps to increase the availability of respirators.”
The Food and Drug Administration (FDA) also issued an Emergency Use Authorization (EUA) letter permitting National Institute for Occupational Safety and Health (NIOSH)-approved, disposable filtering facepiece respirators, including those that were NIOSH-approved but have since passed the manufacturer’s recommended shelf life, to be used in healthcare settings to mitigate further transmission of SARS-CoV-2.
During N95 filtering facepiece respirator (FFR) shortages, the federal government advises that specific N95 FFRs that are beyond their manufacturer’s recommended shelf life will provide greater protection than surgical masks (such as facemasks, other than surgical N95s; see below) or non-NIOSH-approved masks (for example, homemade masks or improvised mouth and nose covers, such as bandanas). NIOSH has tested a sample of N95 FFRs that are beyond their manufacturer’s recommended shelf life from facilities across the United States and determined that certain N95 models continue to protect against the hazards for which they would ordinarily be appropriate (for N95 FFRs, this means they are still expected to filter out 95% of particles of the most penetrating particle size, or 0.3 µm). However, the Centers for Disease Control and Prevention (CDC) and NIOSH have recommended that expired N95 FFRs be used only as outlined in their Strategies for Optimizing the Supply of N95 Respirators. More information is available here.
Enforcement Guidance
All employers whose employees are required to use or are permitted voluntary use of respiratory protection must continue to manage their respiratory protection programs (RPPs) in accordance with the OSHA respirator standard, and should pay close attention to shortages of N95s during the COVID-19 pandemic. Paragraph (d)(1)(iii) in section 1910.134 requires such employers to identify and evaluate respiratory hazards in the workplace, and paragraph (c)(1) requires employers to develop and implement written RPPs with worksite-specific procedures and to update their written programs as necessary to reflect changes in workplace conditions that affect respirator use. CSHOs should generally refer to Inspection Procedures for the Respiratory Protection Standard for further guidance.
Due to the impact on workplace conditions caused by limited supplies of N95 FFRs, all employers should reassess their engineering controls, work practices, and administrative controls to identify any changes they can make to decrease the need for N95 respirators. Employers should, for example, consider whether it is possible to increase the use of wet methods or portable local exhaust systems or to move operations outdoors. In some instances, an employer may also consider taking steps to temporarily suspend certain non-essential operations.
If respiratory protection must be used, employers may consider use of alternative classes of respirators that provide equal or greater protection compared to an N95 FFR, such as NIOSH-approved, non-disposable, elastomeric respirators or powered, air-purifying respirators (PAPRs). Other filtering facepiece respirators, such as N99, N100, R95, R99, R100, P95, P99, and P100, are also permissible alternatives for those who are unable to obtain N95 FFRs. However, per 29 CFR § 1910.134(d)(1)(ii), when considering N95 alternatives, check to ensure that they are NIOSH-approved. When these alternatives are not available, or where their use creates additional safety or health hazards, employers may consider the extended use or reuse of N95 FFRs or use of N95 FFRs that were NIOSH-approved but have since passed the manufacturer’s recommended shelf life.
The following specific enforcement guidance is provided for CSHOs inspecting workplaces where workers are using N95 FFRs.
All Employers
Extended use or reuse of N95s
In the event extended use or reuse of N95 FFRs becomes necessary, the same worker is permitted to extend use of or reuse the respirator, as long as the respirator maintains its structural and functional integrity and the filter material is not physically damaged, soiled or contaminated (for example, with blood, oil or paint).
Employers must address in their written RPPs the circumstances under which a disposable respirator will be considered contaminated and not available for extended use or reuse. Extended use is preferred over reuse due to contact transmission risk associated with donning and doffing during reuse. When respirators are being re-used, employers should pay particular attention to workers’ proper storage of the FFRs in between periods of reuse.
- Users should perform a user seal check each time they don a respirator and should not use a respirator on ich they cannot perform a successful user seal check.
- Employers should train workers to understand that if the structural and functional integrity of any part of the respirator is compromised, it should be discarded, and that if a successful user seal check cannot be performed, another respirator should be tried to achieve a successful user seal check.
- If reuse of respirators is necessary, an appropriate sequence for donning and doffing procedures should be used to prevent contamination, and training needs to address appropriate donning and doffing procedures.
Use of expired N95s
In the event that N95s are not available and the employer has shown a good faith effort to acquire the respirators or to use alternative options, as outlined below, CSHOs should exercise enforcement discretion for the use of N95 FFRs beyond the manufacturer’s recommended shelf life, including surgical N95s.
- Employers may use only previously NIOSH-certified expired N95 FFRs found here. Workers should be notified that they are using expired N95s.
- Purchasers and users of personal protective equipment should not co-mingle products that are past their manufacturer’s recommended shelf life (expired) with items that are within their shelf life.
- Employers should visually inspect, or ensure that workers visually inspect, the N95 FFRs to determine if the structural and functional integrity of the respirator has been compromised. Over time, components such as the straps, nose bridge, and nose foam material may degrade, which can affect the quality of the fit and seal.
- Where an employer has expired N95s available from their own stored cache (in other words, not from the U.S. Strategic National Stockpile), the employer should seek assistance from the respirator manufacturer or independent lab regarding testing of those stored respirators prior to use.
Healthcare Employers Only
Expired N95s generally must not be used when HCP:
- Perform surgical procedures on patients infected with, or potentially infected with, SARS-CoV-2, or perform or are present for procedures expected to generate aerosols or procedures where respiratory secretions are likely to be poorly controlled (for example, cardiopulmonary resuscitation, intubation, extubation, bronchoscopy, nebulizer therapy, sputum induction).
- In accordance with CDC guidance for optimizing the supply of respirators, employers should prioritize the use of N95 respirators by activity type. When HCP perform or are present for aerosol-generating procedures or procedures where respiratory secretions are likely to be poorly controlled, use respirators (including N95 FFRs; other FFRs; non-disposable, elastomeric respirators; and PAPRs) that are still within their manufacturer’s recommended shelf life, if available, before using respirators that are beyond their manufacturer’s recommended shelf life. The CDC guidance also addresses scenarios in which other crisis standards of care may need to be considered, but this enforcement guidance is not intended to cover those scenarios.
As mentioned above, the FDA has concluded that respirators approved by NIOSH, but not currently meeting the FDA’s requirements, may be protective against SARS-CoV-2. The FDA is providing a list of authorized emergency-use respirators for HCP. Healthcare employers may view the list of approved respirators, and respirator manufacturers and stockpile managers may find information about how to obtain approval for expired respirators here.
Citation Guidance
OSHA will, on a case-by-case basis, exercise enforcement discretion when considering issuing citations under 29 CFR §1910.134(d) or the equivalent respiratory protection provisions of other health standards in cases where:
- The employer has made a good faith effort to obtain other alternative filtering facepiece respirators, reusable elastomeric respirators, or PAPRs appropriate to protect workers;
- The employer has monitored its supply of N95s and prioritized their use according to CDC guidance;
- Surgical masks and eye protection (for example: face shields, goggles) were provided as an interim measure to protect against splashes and large droplets (note: surgical masks are not respirators and do not provide protection against aerosol-generating procedures); and
- Other feasible measures, such as using partitions, restricting access, cohorting patients (health care), or using other engineering controls, work practices or administrative controls that reduce the need for respiratory protection, were implemented to protect employees.
Where the above efforts are absent and respiratory protection use is required, or voluntary use is permitted, and an employer fails to comply with fit testing, maintenance, care and training requirements, cite the applicable provision(s) of 29 CFR § 1910.134 or other applicable expanded health standards as serious violations. If you have any questions regarding this policy, please contact the directorate of enforcement programs at (202) 693-2190.
Source: Occupational Health and Safety Administration
This Compliance Bulletin is not intended to be exhaustive nor should any discussion or opinions be construed as legal advice. Readers should contact legal counsel for legal advice. Design ©2020 Zywave, Inc. All rights reserved.
