Information contained in this publication is intended for informational purposes only and does not constitute legal advice or opinion, nor is it a substitute for the professional judgment of an attorney.
The Occupational Safety and Health Administration (OSHA) has issued two separate enforcement memoranda related to the use of respirators by healthcare and non-healthcare employers, given the shortage of N95 filtering facepiece respirators (FFRs) across industry as a result of the COVID-19 outbreak. The first was issued on April 3, 2020, and the second appears to have been issued a day later. Vice President Pence and other public health officials have encouraged non-healthcare employers in recent weeks to donate N95 FFRs to healthcare workers during this time. Prior to the issuance of these memoranda, however, OSHA had provided no guidance to employers regarding potential OSHA liability if respirators are not available or non-healthcare employers follow the recommendations of the federal government and donate their supplies of FFRs.
The memoranda concern different, but related, issues facing employers with respect to the respirator shortage. While they do not address many of the issues facing employers regarding respirator shortages and do not discuss the implications of employers’ donating their stockpiles of respirators to healthcare workers, the memoranda give employers limited relief from OSHA’s Respiratory Protection standard as a result of the outbreak. The memoranda apply to all industries and are “time-limited to the current public health crisis.” The first memoranda gives employers relief to extend the use of National Institute for Occupational Safety and Health (NIOSH)-approved respirators and to permit the reuse of them. The second memoranda allows employers in certain circumstances to use respirators approved by another country, where NIOSH-approved respirators are not available.
Use of Expired Respirators and Respirator Reuse
In OSHA’s first memorandum to Regional Administrators, issued on April 3, 2020, OSHA permits in limited situations the extended use and reuse of NIOSH-approved N95 FFRs and N95 FFRs with an expired shelf life. To that end, OSHA provides the following guidance to employers:
- All employers whose employees are required to use or are permitted to use respiratory protection, must continue to manage their respiratory protection programs in accordance with the OSHA respirator standard.
- 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 FFRs. OSHA does not explain in the memorandum how this assessment differs from an employer’s previous obligations to implement all feasible engineering and work-practice controls before using respirators. OSHA states that in “some instances, an employer may also consider taking steps to temporarily suspend certain non-essential operations.”
- If respiratory protection must be used, employers should consider alternative types of respirators that provide equal or greater protection compared to an N95 FFR. OSHA does not address potential shortages of these respirators during the COVID-19 crisis or that these other NIOSH-approved respirators are also appropriate to use in healthcare settings and thus will likely be in short supply.
OSHA then states that when alternative respirators 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.
In the memorandum, CSHOs are specifically directed as follows for “all employers” and “healthcare employers.”
Extended use or reuse of N95s – If extended use or reuse of N95 FFRs becomes necessary, the same employee 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. Employers must also address this in their written respiratory protection program and train employees on the procedures.
Use of expired N95s – If N95s are not available and the employer has shown a good-faith effort to acquire the respirators or to use alternative options, CSHOs are instructed to exercise enforcement discretion for the use of N95 FFRs beyond the manufacturer’s recommended shelf life. OSHA notes, however, that employers may use only previously NIOSH-certified expired N95 FFRs. OSHA also states that 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.”
For healthcare employers, OSHA states that expired N95s generally must not be used when a healthcare professional (HCP) performs surgical procedures on patients infected with, or potentially infected with, COVID-19, or performs or are present for procedures expected to generate aerosols. When an HCP performs or is present for aerosol-generating procedures, respirators that are still within their manufacturer’s recommended shelf life must be used, if available, before using respirators that are beyond their manufacturer’s recommended shelf life.
In sum, in order to avoid a citation under OSHA’s Respiratory Protection standard, when an employer does not have a supply of current N95 FFRs, the employer must, according to this memorandum:
- Make a good-faith effort to obtain other alternative FFRs, reusable elastomeric respirators, or powered, air-purifying respirators (PAPRs) appropriate to protect workers;
- Monitor their supply of N95s and prioritize their use according to CDC guidance (www.cdc.gov/coronavirus/2019-ncov/release-stockpiled-N95.html; www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html);
- Provide surgical masks and eye protection as an interim measure to protect against splashes and large droplets; and
- Implement other feasible measures, such as using partitions or using other engineering controls, work practices, or administrative controls that reduce the need for respiratory protection.
If an employer does not take all of these actions, and respiratory protection use is required, or voluntary use is permitted, the employer will be cited under “the applicable provision(s) of 29 CFR § 1910.134 and/or other applicable expanded health standards as serious violations.”
Use of non-NIOSH Approved Respirators
In the second enforcement memorandum, OSHA permits the use of non-NIOSH approved respirators. OSHA’s respiratory protection standard requires that any respirator required or permitted to be used be approved by NIOSH. As a result of the COVID-19 outbreak, however, OSHA is relaxing those requirements. Specifically, as explained in the second memorandum, OSHA is permitting the use of FFRs and air-purifying elastomeric respirators that are either:
- Certified under certain standards of other countries; or
- Previously certified under the standards of other countries but beyond their manufacturer’s recommended shelf life. This option is available only if equipment certified under standards of other countries is not available.
The enforcement memorandum lists those respirators that OSHA deems acceptable, but provides that respirators certified by the Peoples Republic of China be used only after respirators from other countries are sought. OSHA states that all employers should prioritize the acquisition and use of equipment in the following order:
- NIOSH-certified equipment.
- Equipment certified in accordance with standards of other countries or jurisdictions except the People’s Republic of China, unless equipment certified in accordance with standards of the People’s Republic of China is manufactured by a NIOSH certificate holder.
- Equipment certified in accordance with standards of the People's Republic of China, the manufacturer of which is not a NIOSH certificate holder.
- Facemasks (e.g., medical masks, procedure masks).
Employers may only acquire and use non-NIOSH-certified respirators after they have exhausted their supply of NIOSH-approved respirators, including those that are beyond their shelf life. It thus appears that OSHA intends for employers to first review and comply with the April 3, 2020 memorandum before complying with the second memorandum. OSHA also states that employers should avoid co-mingling products from different categories of equipment.
For healthcare employers, OSHA’s enforcement position is more restrictive with respect to the use of non-NIOSH-approved respirators. When an HCP performs surgical procedures on patients infected with, or potentially infected with, COVID-19, respirators certified exclusively in accordance with standards of the People's Republic of China and manufactured by companies that are not NIOSH approval holders may not be used unless the only feasible alternative is a facemask or improvised nose/mouth cover. OSHA states that healthcare employers should prioritize the use of NIOSH-approved N95 respirators by activity type.
When using non-NIOSH-approved respirators, all employers are expected to follow the same basic general respiratory protection program and training requirements as set forth by OSHA in the April 3, 2020 memorandum.
While OSHA’s guidance provides some flexibility for employers, it does not address all employer concerns with respect to supply shortages. For example, it requires employers to reassess engineering or work-practice controls, even though by policy employers will have already implemented all engineering and work-practice controls before using respiratory protection. It also provides non-healthcare employers no relief if they donate N95 FFRs to healthcare workers, as that situation is not addressed in either memoranda. In fact, to receive enforcement relief, an employer must have in good faith attempted to obtain N95 respirators. Donating supplies of N95 respirators would be inconsistent with demonstrating good faith to obtain N95 respirators. Thus, if non-healthcare employers choose to donate their N95 FFRs to healthcare workers, they could still be subject to citation.
Employers should carefully review the OSHA guidance and adjust their respiratory protection practices accordingly.