Federal Register - June 21, 2021

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Source: Federal Register

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Federal Register / Vol. 86, No. 116 / Monday, June 21, 2021 / Rules and Regulations
respirator performs a user seal check each time they put on the respirator. A
tight-fitting respirator is defined as a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator e.g., filtering facepiece. Tight-fitting respirators include all FFRs e.g., N95s and most elastomeric respirators, and under paragraph d2 of the mini respiratory protection program section, they require a user seal check. Many PAPRs used in healthcare settings are loose-fitting and therefore do not require a user seal check. User seal check is defined as an action conducted by the respirator user to determine if the respirator is properly seated to the users face. A user seal check ensures an adequate seal is achieved, and can be conducted by either a positive pressure or negative pressure check.
Under paragraph d2 of the mini respiratory protection program section, employers must ensure that employees perform a user seal check each time a tight-fitting respirator is put on. This requirement is meant to ensure that the respirator is properly seated on the users face i.e., that the proper seal has been achieved whenever they are wearing it. Paragraphs d2iA and B of the mini respiratory protection program section explain methods for conducting positive pressure and negative pressure seal checks. Both methods require, as the first step, that the employee conducts proper hand hygiene and properly dons their respirator. When conducting hand hygiene in most clinical settings, the CDC recommends use of an alcoholbased hand rub over soap and water, unless hands are visibly soiled; this is due to evidence of better compliance with the use of hand rub compared to soap and water. However, the CDC does recommend that healthcare workers wash their hands for at least 20 seconds with soap and water when hands are visibly dirty, before eating, and after using the restroom CDC, May 17, 2020.
As described in paragraph d2iA, the proper method for conducting a positive pressure user seal check is to have the employee exhale into the respirator while covering the filter surface with their hands. If there is no evidence of leaks and the employee can feel a slight outward pressure on the surface of the respirator, proper fit has likely been achieved and the fit is considered satisfactory. The proper method for performing a negative pressure user seal check, under paragraph d2iB, is to have the employee inhale while covering the filter surface with their hands. Proper fit
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has likely been achieved, and the fit is considered satisfactory, if the respirator collapses on the face and the employee does not feel air passing between their face and the facepiece of the respirator.
Paragraph d2ii of the mini respiratory protection program section requires the employer to ensure that the employee corrects any seal problems discovered during the user seal check by readjusting how the respirator sits on the employees face, readjusting the nosepiece, if applicable, and readjusting the straps along the sides of the head.
When an employee is required to wear a respirator and a problem with the seal check arises due to interference with the seal by an employees facial hair, a note to paragraph d2i and ii of the mini respiratory protection program section reminds employers that they may provide a different type of respirator to accommodate an employee who cannot trim or cut facial hair due to their religious beliefs. In such cases, if the employee cannot achieve a seal with a FFR or elastomeric respirator, a loose-fitting PAPR may be the only alternative that provides effective protection.
Paragraph d3 of the mini respiratory protection program section describes the requirements employers must follow for reuse of respirators that are provided by the employer, with specific requirements for FFRs paragraph d3i and for elastomeric respirators and PAPRs paragraph d3ii. Reuse of respirators has been necessary in some cases during the COVID19 pandemic, particularly at the beginning of the pandemic when shortages of respirators were most acute.
When respirators are reused, it is important that proper procedures are followed and that reuse is limited to ensure they continue to effectively protect the user.
Paragraph d3i of the mini respiratory protection program section describes the requirements for reuse of FFRs. FFRs are designed and manufactured as disposable items of personal protective equipment that should normally be discarded after a single use. Therefore, the note to paragraph d3i states that reuse of single-use respirators is discouraged.
Reuse of FFRs used under this section, however, poses less of a concern than reuse of respirators used in other situations, given that there should be no suspected or confirmed sources of COVID19 present when such reuse occurs. Even so, it is important that reuse of FFRs is permitted only under the conditions set out in paragraph d3i.

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There are several requirements for the reuse of FFRs under paragraph d3i of the mini respiratory protection program section. The employer must ensure that an FFR is only reused by one employee, and that it is only reused when not visibly soiled or damaged.
The employer must ensure that the employee visually checks the respirators fabric and seal for damage in adequate lighting. In addition, the employer must ensure that the employee completes the user seal check as described in paragraph d2 of the same section before each use. As explained earlier, the user seal check is needed to ensure the respirator is properly seated on the users face. The employer must also ensure that the employee uses proper hand hygiene before putting on their respirator and conducting the user seal check. Proper hand hygiene will help keep the respirator clean and avoid the transmission of potentially infectious material from the employees hands to the respirator.
The employer must ensure that each FFR reused in accordance with paragraph d3i of the mini respiratory protection program is not worn for more than five days, in total.
This limit is generally consistent with CDC guidance, which recommends that, in the absence of guidance from the manufacturer, reuse be limited to no more than five uses per device to ensure adequate respirator performance CDC, April 9, 2021. The CDCs technical literature regarding how to ensure safe reuse of an FFR discusses the number of times a user may don a single FFR, as well as variability among FFRs made by different manufacturers. Given these factors, OSHA has set the limit at five days to provide flexibility and improve the feasibility of the standard, while ensuring employees remain protected. It should also be noted that the inspection of the respirator, as well as the user seal check, both of which must be performed by the employee each time a respirator is put on, provide additional safeguards to ensure the respirator is still in proper condition for reuse. It is also important that employers track usage to ensure that each respirator is discarded after five days of use. One way to do so is to attach a small tag to a respirator strap and mark it after each days use.
Similarly, a tag could be attached to the respirators storage bag to track total use, or the information could be written directly on a paper bag.
Finally, under paragraph d3i of the mini respiratory protection program, employers must also ensure that each reused respirator is stored in a breathable container, such as a paper
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Federal Register - June 21, 2021

TitoloFederal Register

PaeseStati Uniti

Data21/06/2021

Conteggio pagine275

Numero di edizioni7798

Prima edizione14/03/1936

Ultima edizione18/06/2026

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