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Federal Register / Vol. 86, No. 116 / Monday, June 21, 2021 / Rules and Regulations
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needed for healthcare workers because respirators provide better fit and filtration characteristics.
The CDC recommendations in Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 COVID19 Pandemic are divided into two separate categories.
These include: 1 Recommended infection prevention and control practices when caring for a patient with suspected or confirmed COVID19; and 2 recommended routine infection prevention and control practices during the COVID19 pandemic CDC, February 23, 2021.
A topic of interest related to the selection and use of respirators is their dual role as both personal protective equipment for the wearer and also source control to reduce the potential for transmission of potentially infectious exhaled air to others. While many filtering facepiece respirators do not have an exhalation valve, other filtering facepiece respirators do. The other higher-level respirators referenced above, and in CDC guidance e.g., half or full facepiece elastomeric respirators and PAPRs, do have exhalation valves. An exhalation valve is a portal in the respirator to allow unfiltered air to leave the respirator in order to reduce breathing resistance for the wearer and reduce moisture and heat buildup inside the respirator.
While the exhalation valve does allow some particles to escape through the valve, it is important to compare the performance of a respirator with an exhalation valve to other acceptable forms of source control in order to determine if there are actually reduced levels of effectiveness. NIOSH studied this issue and released a technical report entitled Filtering Facepiece Respirators with an Exhalation Valve:
Measurements of Filtration Efficiency to Evaluate Their Potential for Source Control NIOSH, December 2020. In the report, NIOSH concluded that respirators with exhalation valves were equally effective as facemasks:
this study found that unmitigated FFRs with an exhalation valve that were tested in an outward position with particles traveling in the direction of exhalation have a wide range of penetration, emitting between <1%
and 55%. Further testing could measure greater particle penetration. Even without mitigation, FFRs with exhalation valves can reduce 0.35-mm MMAD particle emissions more consistently than surgical masks, procedure masks, cloth face coverings, or fabric from cotton t-shirts; . . . FFRs with an exhalation valve provide respiratory protection to the wearer, and this study demonstrates that they can also reduce 0.35mm MMAD particle emissions to levels
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similar to or better than those provided by surgical masks and unregulated barrier face coverings.

The results that NIOSH observed can be explained in two ways. First, the majority of the leakage takes place around the seal by the nose and mouth, and respirators are designed to provide tight seals around the face so that there is only minimal leakage. Facemasks, on the other hand, do not typically seal tightly to the face and thus significant quantities of unfiltered air with small particles will also escape through the gaps on the side and at the nose, as well as potentially through the fabric of less protective filter materials. Second, the level of filtration in facemasks is highly variable, so a wide range of filter efficiencies have been acceptable under CDC guidance. The CDC does not recommend that respirators with exhaust valves be used as source controls, but the CDCs last updated recommendation on this subject was published in August of 2020, four months before the NIOSH study, and cited lack of data as the basis for the warning against relying on such respirators CDC, April 9, 2021b.
Therefore, the NIOSH study with its conclusion that respirators with exhaust valves are not less adequate as source controls than other acceptable source controls, appears to represent the best available evidence. OSHA therefore concludes that at this time there is no basis for OSHA to prohibit any NIOSHapproved filtering facepiece respirator from serving as both personal protective equipment and as source control. The NIOSH report also details methods of covering the filtering facepiece respirators exhalation valve in various manners to further improve the effectiveness as source control, which OSHA considers a recommended practice, but not strictly necessary.
There are also other methods that can be used to cover or filter the exhalation valve of elastomeric respirators e.g., place a medical mask over the respirator.
II. The CDCs Recommended Infection Prevention and Control Practices When Caring for a Patient With Suspected or Confirmed COVID19
The CDC recommends that healthcare personnel including workers that perform healthcare services and those that perform healthcare support services who enter the room or area of a patient with suspected or confirmed COVID19 adhere to Standard Precautions plus gown, gloves, and eye protection, and also use a NIOSHapproved N95 filtering facepiece or equivalent or higher-level respirator.

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The CDC notes in a set of FAQs that its recommendation to use NIOSHapproved N95 disposable filtering facepiece or higher-level respirators when providing care for patients with suspected or known COVID19 is based on the current understanding of the COVID19 virus and related respiratory viruses CDC, March 10, 2021.
As noted above, the CDC
recommendations listed in Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 COVID19 Pandemic are applicable to all U.S. settings where healthcare is delivered. To this end, the recommendations on respirator use are repeated in a variety of additional CDC
guidelines for specific categories of healthcare settings e.g., nursing homes, dental settings, assisted living facilities, home health care settings. For example, in its guidance for nursing homes, the CDC recommends that residents with known or suspected COVID19 be cared for while using all recommended PPE, including an N95 or higher-level respirator CDC, March 29, 2021. In addition, in its guidance for dental settings, the CDC recommends that dental healthcare personnel who enter the room of a patient with suspected or confirmed COVID19 use a NIOSHapproved N95 or equivalent or higherlevel respirator, as well as other PPE
CDC, December 4, 2020. Additionally, in its guidance for assisted living facilities, the CDC recommends an N95
or higher-level respirator for personnel for situations where close contact with any symptomatic or asymptomatic resident cannot be avoided, if COVID
19 is suspected or confirmed in a resident of the assisted living facility i.e., resident reports fever or symptoms consistent with COVID19 CDC, May 29, 2020. Also, in its guidance for home healthcare settings, the CDC
recommends that when home health agency personnel are involved in the care of people with confirmed or suspected COVID19 at their homes, the personnel adhere to relevant infection prevention and control practices as described in the core healthcare guidance Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 COVID19
Pandemic i.e., that they use N95 or higher-level respirators CDC, October 16, 2020.
In addition to its infection prevention and control guidelines for healthcare personnel in healthcare settings, the CDC has issued infection prevention and control guidelines for conducting postmortem procedures on decedents/

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