N95 and KN95 Respirator Misconceptions

On April 3 OSHA distributed a news release  “U.S. Department of Labor Issues Guidance for Respiratory Protection During N95 Shortage Due to COVID-19 Pandemic”.  In that release it states “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 National Institute for Occupational Safety and Health (NIOSH)-approved, non-disposable, elastomeric respirators or powered, air-purifying respirators”.   There was great rejoicing and we were all buried under an avalanche of vendors promising delivery of the KN95 respirators from China, approved as an alternative by the CDC.

It all seemed too easy and logical, however the OSHA news release is misleading.  The link in the news release  leads to an OSHA Guidance Document, which does not permit the use of respirators from other countries that are not approved by NIOSH.

In the news release, which mysteriously disappeared from the OSHA site, it contains a link to an enforcement document “Enforcement Guidance for Respiratory Protection and the N95 Shortage Due to the Coronavirus Disease 2019 (COVID-19) Pandemic”  In that document, it states “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.”  In this document, the health care industry received permission to use NIOSH approved respirators not meeting FDA requirements.  This did not include respirators such as KN95.

So, realizing that this news release and included linked document accomplished nothing, a second enforcement document was issued on that same date entitled “U.S. Department Of Labor Issues Guidance for Respirators Certified under Other Countries’ Standards During COVID-19 Pandemic” In summary, that document appears to give permission for employers to consider using respirators and filters certified under standards of other countries, which includes the KN95 from China, the birthplace of the coronavirus.

At first glance it appears that this was permission for all industries.  However, this document refers to several CDC guidance documents, all in regards to the health care industry.  Furthermore, there are items in this document that even in the most desperate of times the construction industry would never be permitted to use as respirator substitutes.

So therefore, it is important to remember that:

  1. This document does not give a carte blanche permission to permit the use of respirators that are not NIOSH approved for any industry other than the health care industry.
  2. The documents presented by OSHA are enforcement guidance documents and not changes in the OSHA regulations.  It uses less affirmative wording, such as should and may.  This is a document that the OSHA compliance officer can use in deciding how to enforce a regulation, by using the less affirmative wording, this guidance is only a suggestion.
  3. In both April 3 guidance documents, OSHA stated that all employers need to implement the hierarchy of controls in an effort first to eliminate or substitute out workplace hazards requiring respiratory protection, then using engineering controls, administrative controls, and safe work practices to prevent worker exposures to respiratory hazards.  The options OSHA offers employers that are not in the health care industry is:
    1. the use of NIOSH approved respirators other than the N95
    2. The use of expired N95s
    3. taking steps to temporarily suspend certain non-essential operations.
  4. With consideration that some companies will supply their workers with KN95 Respirators as protection from the coronavirus, there is no regulation that would prevent this.  However, as the KN95 has been classified as a respirator by the CDC the elements of the OSHA Respiratory Protection Program requirements would be enforceable.  This would include the need to have a written program, user medical evaluation, user fit testing, and training.  The Voluntary Use of Respirator form would also be applicable if the KN95 was offered but not mandated.

I honestly do not think OSHA is on the hunt looking for unapproved respirators.  However, OSHA is very clear that all safety and health regulations remain active during the pandemic crisis.  The additional liability is that workers wearing respirators experience restricted air flow from any respirator.  That is why a medical evaluation is necessary prior to their use which may determine that the physiological burden on the heart and lungs would preclude the worker from wearing one.