OSHA Respiratory Protection Standard Enforcement Requirements During COVID-19 N95 Shortage

04.06.2020

Due to an increased demand for N95 respirators during the COVID-19 pandemic, healthcare workers and emergency response has faced limited availability for use in protecting against exposure. In an effort to combat this shortage, OSHA has issued interim enforcement guidance memorandum for enforcing the Respiratory Protection standard 29 CFR § 1910.134 and other health standards that takes effect immediately until further notice.  It applies to all industries as well as those where healthcare personnel are exposed to patients confirmed or suspected to have COVID-19 or other sources of SARS-CoV-2, and workplaces where worker protection from respiratory hazards has been impacted by the shortage.

During the shortage, the Federal government has advised that particular, NIOSH-tested N95 FFRs that are past the recommended shelf life offer better protection than surgical masks, or non-NIOSH-approved masks. The CDC and NIOSH have recommended that expired N95 FFR’s should only be used as outlined in their Strategies for Optimizing the Supply of N95 Respirators.

OSHA’s Enforcement Guidance

OSHA instructs that employers whose employees require use/permitted voluntary use of respiratory protection must continue to manage respiratory protection programs in accordance with OSHA respiratory standard and are advised to pay close attention to shortages of N95s.

Under paragraph (d)(1)(iii) (www.osha.gov/laws-regs/standardinterpretations/2017-12-20), OSHA states that employers are required to identify and evaluate respiratory hazards and develop and implement RPPs with worksite specific procedures and update their programs to reflect changes in workplace conditions that affect respirator use. Due to the shortage OSHA asks employers to reassess their engineering and administrative controls as well as work practices to find any changes that can decrease the need for N95 respirators.

If the above alternatives are not available OSHA is permitting the extended use or reuse of N95 FFR’s that were approved but have since passed the manufacturer’s recommended shelf life.

OSHA guidance for All Employers:

In circumstances where protection must be used, OSHA asks employers to consider using alternative classes that are equal or greater in protection compared to an N95 FFR. These include:

  • NIOSH-approved, non-disposable elastomeric respirators or powered, air-purifying respirators
  • as well as other filtering facepiece respirators including N99, N100, R95, R99, R100, P95, P99, and P100.
    • Alternatives must be NIOSH-approved to be permissible and must maintain structural and functional integrity where filter material is not damaged, soiled or contaminated.

Employers must address circumstances that will cause a respirator to be considered contaminated and not available for extended use/reuse and must train workers to understand the appropriate sequence for donning/removing procedures, understanding when structural/functional integrity is compromised, and how to conduct a proper seal check. If any of these prove to be unsuccessful the respirator should not be used.

If using expired N95s OSHA states that employers may only use previously NIOSH-certified expired N95s. Purchasers and users of PPE should no co-mingle products past their shelf life with items in their shelf life, a visual inspection should be done to determine if structural and functional integrity is intact, and employers with their own stock of expired N95s should seek assistance from respirator manufacturer to test them prior to use.

OSHA guidance for Healthcare employers only:

Expired N95s are not permitted for use when healthcare personnel perform surgical procedures on those with or suspected to have COVID-19, or perform or are present for procedures expected to generate aerosols or procedures where respiratory secretions are likely to be poorly controlled.

The CDC guidance advises employers prioritize the use of N95 respirators by activity type which information can be found here www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/contingency-capacity-strategies.html.

OSHA’s previous memorandum Temporary Enforcement Guidance – Healthcare Respiratory Protection Annual Fit-Testing for N95 Filtering Facepieces During the COVID-19 Outbreak provides guidance regarding required annual fit testing of Healthcare Personnel and can be found here https://www.osha.gov/memos/2020-03-14/temporary-enforcement-guidance-healthcare-respiratory-protection-annual-fit .

Respirators approved by NIOSH but not currently meeting FDA’s requirements may still be protective according to OSHA. To view this list and information about how to obtain approval for expired respirators visit www.fda.gov/media/135763/download and www.fda.gov/media/135921/download.

OSHA guidance on considering citations under 29 CFR § 1910.134(d) and other respiratory health care standards.

On a case-by-case basis OSHA will exercise enforcement discretion in cases where they list the  following:

  • 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 their supply of N95s and prioritized their use according to CDC guidance (www.cdc.gov/coronavirus/2019-ncov/release-stockpiled-N95.htmlwww.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html);
  • Surgical masks and eye protection (e.g., 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 (healthcare), or using other engineering controls, work practices, or administrative controls that reduce the need for respiratory protection, were implemented to protect employees.

In circumstances where respiratory protection is required or voluntary use is permitted if these efforts are absent, and the employer fails to comply with fit testing, maintenance, care and training requirements OSHA will consider it as a serious violation.

Due to an increased demand for N95 respirators during the COVID-19 pandemic, healthcare workers and emergency response has faced limited availability for use in protecting against exposure. In an effort to combat this shortage, OSHA has issued interim enforcement guidance memorandum for enforcing the Respiratory Protection standard 29 CFR § 1910.134 and other health standards that takes effect immediately until further notice.  It applies to all industries as well as those where healthcare personnel are exposed to patients confirmed or suspected to have COVID-19 or other sources of SARS-CoV-2, and workplaces where worker protection from respiratory hazards has been impacted by the shortage.

During the shortage, the Federal government has advised that particular, NIOSH-tested N95 FFRs that are past the recommended shelf life offer better protection than surgical masks, or non-NIOSH-approved masks. The CDC and NIOSH have recommended that expired N95 FFR’s should only be used as outlined in their Strategies for Optimizing the Supply of N95 Respirators.

OSHA’s Enforcement Guidance

OSHA instructs that employers whose employees require use/permitted voluntary use of respiratory protection must continue to manage respiratory protection programs in accordance with OSHA respiratory standard and are advised to pay close attention to shortages of N95s.

Under paragraph (d)(1)(iii) (www.osha.gov/laws-regs/standardinterpretations/2017-12-20), OSHA states that employers are required to identify and evaluate respiratory hazards and develop and implement RPPs with worksite specific procedures and update their programs to reflect changes in workplace conditions that affect respirator use. Due to the shortage OSHA asks employers to reassess their engineering and administrative controls as well as work practices to find any changes that can decrease the need for N95 respirators.

If the above alternatives are not available OSHA is permitting the extended use or reuse of N95 FFR’s that were approved but have since passed the manufacturer’s recommended shelf life.

OSHA guidance for All Employers:

In circumstances where protection must be used, OSHA asks employers to consider using alternative classes that are equal or greater in protection compared to an N95 FFR. These include:

  • NIOSH-approved, non-disposable elastomeric respirators or powered, air-purifying respirators
  • as well as other filtering facepiece respirators including N99, N100, R95, R99, R100, P95, P99, and P100.
    • Alternatives must be NIOSH-approved to be permissible and must maintain structural and functional integrity where filter material is not damaged, soiled or contaminated.

Employers must address circumstances that will cause a respirator to be considered contaminated and not available for extended use/reuse and must train workers to understand the appropriate sequence for donning/removing procedures, understanding when structural/functional integrity is compromised, and how to conduct a proper seal check. If any of these prove to be unsuccessful the respirator should not be used.

If using expired N95s OSHA states that employers may only use previously NIOSH-certified expired N95s. Purchasers and users of PPE should no co-mingle products past their shelf life with items in their shelf life, a visual inspection should be done to determine if structural and functional integrity is intact, and employers with their own stock of expired N95s should seek assistance from respirator manufacturer to test them prior to use.

OSHA guidance for Healthcare employers only:

Expired N95s are not permitted for use when healthcare personnel perform surgical procedures on those with or suspected to have COVID-19, or perform or are present for procedures expected to generate aerosols or procedures where respiratory secretions are likely to be poorly controlled.

The CDC guidance advises employers prioritize the use of N95 respirators by activity type which information can be found here www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/contingency-capacity-strategies.html.

OSHA’s previous memorandum Temporary Enforcement Guidance – Healthcare Respiratory Protection Annual Fit-Testing for N95 Filtering Facepieces During the COVID-19 Outbreak provides guidance regarding required annual fit testing of Healthcare Personnel and can be found here https://www.osha.gov/memos/2020-03-14/temporary-enforcement-guidance-healthcare-respiratory-protection-annual-fit .

Respirators approved by NIOSH but not currently meeting FDA’s requirements may still be protective according to OSHA. To view this list and information about how to obtain approval for expired respirators visit www.fda.gov/media/135763/download and www.fda.gov/media/135921/download.

OSHA guidance on considering citations under 29 CFR § 1910.134(d) and other respiratory health care standards.

On a case-by-case basis OSHA will exercise enforcement discretion in cases where they list the  following:

  • 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 their supply of N95s and prioritized their use according to CDC guidance (www.cdc.gov/coronavirus/2019-ncov/release-stockpiled-N95.htmlwww.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html);
  • Surgical masks and eye protection (e.g., 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 (healthcare), or using other engineering controls, work practices, or administrative controls that reduce the need for respiratory protection, were implemented to protect employees.

In circumstances where respiratory protection is required or voluntary use is permitted if these efforts are absent, and the employer fails to comply with fit testing, maintenance, care and training requirements OSHA will consider it as a serious violation.