On March 14, the Occupational Safety and Health Administration issued initial Guidance explaining that due to the shortage of N95 filtering facepiece respirators, the Agency was not requiring health care employers to conduct annual fit tests as required under the Respiratory Protection Standard. This guidance has now been expanded upon by two additional Guidance Documents.

On April 3, OSHA issued an interim guidance memorandum permitting the “extended use and re-use of respirators, as well as the use of respirators that are beyond their manufacturer’s recommended shelf life. . . .” This guidance applies to all industries, not just to health care. The new interim enforcement memo does not address the use of surgical masks or other paper or cloth masks other than to say that re-used or out-of-date N95 masks are more protective than surgical masks.

OSHA emphasizes that despite the widespread shortage of N95 respirators, employers must continue to comply with all of the other requirements of the Respiratory Protection Standard, apart from the two narrow exceptions noted above. In fact, OSHA advises that because of the limited supplies of N95 respirators, 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,” such as “to temporarily suspend certain non-essential operations.”

Extended use or re-use of N95s

If extended use or re-use of an N95 is necessary, OSHA instructs that a worker can continue to use the N95 “as long as the respirator maintains its structural and functional integrity and the filter material is not physically damaged, soiled, or contaminated (e.g., with blood, oil, paint).” Without distinguishing between voluntary and required use of the N95s, OSHA states that employers “must address” in a written Respiratory Protection Plan “the circumstances under which a disposable respirator will be considered contaminated and not available for extended use or reuse.”

OSHA further advises that employers should also ensure that users of N95 masks perform a user seal check each time they don a respirator, and that employers should train employees to understand when “the structural and functional integrity of any part of the respirator is compromised” and needs to be discarded.

Use of expired N95s

As noted above, employers are being allowed to use expired N95s if the employer has made a good faith effort to acquire in-date respirators and cannot acquire any. Users of the out-of-date N95s are instructed not to co-mingle them with N95s that are within their shelf life and to visually inspect the respirators to determine whether their structural and functional integrity has been compromised.

Use of other countries’ respirators

A second Guidance Document was also issued on April 3, which allows the use of filtering facepiece respirators, air-purifying respirators, and compatible filters certified under Standards from other countries when N95s approved by the National Institute for Occupational Safety and Health are not available:

  • Australia: AS/NZS 1716:2012

  • Brazil: ABNT/NBR 13694:1996; ABNT/NBR 13697:1996; and ABNT/NBR 13698:2011

  • People's Republic of China: GB 2626-2006; and GB 2626-2019

  • European Union: EN 140-1999; EN 143-2000; and EN 149-2001

  • Japan: JMHLW-2000

  • Republic of Korea: KMOEL-2014-46; and KMOEL-2017-64

  • Mexico: NOM-116-2009

Health care employers only

Expired N95s must not be used when health care professionals perform surgical procedures on patients infected with, or potentially infected with, the coronavirus, or are present for procedures expected to generate aerosols, or “where respiratory secretions are likely to be poorly controlled” (e.g., cardiopulmonary resuscitation, intubation, extubation, bronchoscopy, nebulizer therapy, sputum induction). For other types of care provided to known or suspected COVID-19 patients, the OSHA Guidance allows expired N95s to be used.

The OSHA Guidance stops short, however, of the current position of the Centers for Disease Control and Prevention, which allows the use of facemasks (which protect the wearer from splashes and sprays) as “an acceptable alternative” for caring for known or suspected COVID-19 patients “when the supply chain of respirators cannot meet the demand.” According to CDC’s Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings, updated on March 10, available respirators should be prioritized for procedures that are likely to generate respiratory aerosols, which would pose the highest exposure risk to health care providers. Although California OSHA has recently announced its policy of allowing facemasks to be used instead of N95s for certain health care tasks when N95 supplies are limited and certain conditions are met, federal OSHA has yet to take that step.

In addition, the Food and Drug Administration will be providing a list of authorized emergency-use respirators for health care professionals that will include some NIOSH-approved respirators that have not previously been approved by the FDA.

Lessons learned

This new guidance has some value for health care employers, but is of very limited use for all other employers who presently cannot get N95s and are being actively discouraged by the federal government from competing against hospitals for these respirators. We will monitor OSHA’s subsequent guidance and let you know when the Agency begins to address the everyday compliance issues confronting non-healthcare employers during the pandemic.

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