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10 CFR Part 20 Respiratory Radiological Protection Requirements

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Highlights

  • Respiratory protection programs are vital for the radiological safety of nuclear plant workers. Though these masks may provide protection against COVID-19 virus, this equipment can be required for worker radiological safety. For example, reactor licensees supply respiratory protection equipment to fire fighters and control room operators to limit intakes of radioactive material during certain emergencies.

  • The NRC is prepared to consider, on an expedited basis, requests by individual licensees for exemptions from medical evaluation and respirator fit-testing frequency requirements that are specified in 10 CFR 20.1703(c)(5)(iii) and 10 CFR 20.1703(c)(6).

  • Regulatory Guide (RG) 8.15, "Acceptable Programs for Respiratory Protection," is still applicable during the public health emergency and allows for a 90-day grace period to complete these requirements. The exemption requests, if approved, would allow licensees to go beyond the scope and duration of the grace periods contemplated in RG 8.15, Revision 1.

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Respiratory Protection Exemptions

Plant Utility Received Issued
TBD      

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Related Communication

  • On April 27, 2020, the NRC issued letters to industry describing a process for licensees for COVID-19-related 10 CFR Part 20 exemptions, (ADAMS Accession No. ML20099G757). Specifically, the letter outlines the process for receiving expedited review of exemption requests from medical evaluation frequency and respirator fit-testing frequency requirements specified in 10 CFR 20.1703(c)(5)(iii) and 10 CFR 20.1703(c)(6).

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Frequently Asked Questions - 10 CFR Part 20

1. Why is the NRC prepared to exempt operating reactor licensees from certain Part 20 respiratory radiological protection requirements?

The NRC is considering, on an expedited basis, requests by individual licensees for exemptions from medical evaluation frequency and fit-testing frequency requirements that are specified in 10 CFR 20.1703(c)(5)(iii) and 10 CFR 20.1703(c)(6). Specifically, if approved, licensees will be exempted from:

  • The requirement for physical medical examinations at medical facilities in order to qualify to wear respiratory protection per 10 CFR 20.1703(c)(5)(iii); and/or

  • The respiratory fit-test requirements of 10 CFR 20.1703(c)(6).

These exemptions may help ensure that respiratory protection program requirements do not result in licensees requiring workers to take actions that are contrary to guidance from the Centers for Disease Control and Prevention. By establishing temporary licensee-specific processes to control overdue requirements and other criteria outlined in the April 27, 2020, letter, the NRC believes that respiratory radiological protection will remain adequate.

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2. Which NRC licensees are eligible to request expedited review of exemption requests under the April 27, 2020 letter?

NRC licensees licensed under 10 CFR Parts 30, 40, 50 70, and 72 may take advantage of the process outlined in the April 27, 2020 letter.

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3. Is the NRC considering expediting exemption requests related to the dose limit requirements in 10 CFR Part 20?

No, NRC is not considering using this expedited-review process for exemptions to the dose limit requirements in Part 20. NRC is considering exemptions from medical evaluation frequency and fit-testing frequency requirements that are specified in 10 CFR 20.1703(c)(5)(iii) and 10 CFR 20.1703(c)(6).

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4. How should a licensee submit an exemption request for expedited review under this process?

Part 50 licensees can submit an exemption from the Part 20 respiratory radiological protection requirements using an online submission on the NRC’s public website. The links to the Power Reactor Licensees form and the link to the Non-Power Reactor Licensees form are listed at the top of this page. Once submitted, the licensee’s online submission will be placed into ADAMS and made publicly available.

Additionally, licensees have the option to submit the expedited exemption request using the normal process, outlined below.

  • Through the Electronic Information Exchange (EIE), along with an email to the plant's Licensing Project Manager. When submitting through EIE, include "EXPEDITE" in the Comment field.

  • As an attachment to an email addressed to the Document Processing Center (docprocessing.center@nrc.gov) and the plant's Licensing Project Manager. The Subject line of the email should include "URGENT – COVID-19 Part 20 Exemption Request"

Whichever method is used, as always, the licensee should ensure that the PDF is in compliance with the NRC's Guidance for Electronic Submissions to the NRC so that it can be promptly added to ADAMS. The Document Control Center will address non-conforming documents with the Licensing Project Manager, who will work with the licensee to resolve the issue and obtain a submittal that can be processed into ADAMS.

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5. Why did the NRC move so quickly on this?

The NRC implemented this expedited review process to allow licensees to quickly receive an answer from the agency regarding the approval or denial of exemption requests where a licensee’s ability to comply with certain Part 20 respiratory radiological protection requirements could be affected by the COVID-19 PHE.

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6. How will reasonable assurance of worker safety be maintained during the exemption period?

When granting an exemption from its Part 20 requirements, the NRC must find that the exemption is authorized by law and would not result in undue hazard to life or property. The NRC will review each exemption request received to ensure that these requirements are met. Although licensees may request exemptions from any of the NRC’s regulatory requirements, and the NRC will conduct a review of each request, the NRC expects that the requests received for review under this expedited process will be broadly similar.

For the exemptions that the NRC expects to receive under the aforementioned expedited process, 10 CFR 20.1703(c)(3) requires the testing of respirators for operability immediately prior to each use; and 10 CFR 20.1703(c)(5)(i)–(ii) and 10 CFR 20.1703(c)(6) require that initial medical evaluations and respiratory fit-tests be completed prior to the first field use of tight-fitting respirators. These requirements, in conjunction with any conditions that the NRC may include in the approval of an exemption, ensure that the exemption would only be applied in necessary situations and that it would not result in undue hazard to life or property.

When granting an exemption, the NRC may impose conditions upon the licensee.

For example, for an exemption from 10 CFR 20.1703(c)(5)(iii), the NRC may include conditions like:

  • The exemption does not apply, and the existing regulations continue in effect when:

    • an employee reports signs or symptoms that could affect his or her ability to use a respirator (unless cleared by a licensed physician);

    • a physician or other licensed health care professional, supervisor, or respirator program administrator informs the licensee that an employee needs to be reevaluated;

    • information from the respiratory protection program, including observations made during fit-testing and program evaluation, indicates a need for employee reevaluation; or

    • a change occurs in workplace conditions (e.g., physical work effort, protective clothing, temperature) that may result in a substantial increase in the physiological burden placed on an employee.

  • All employees affected by this exemption must be informed of the general risks of wearing respiratory protection (e.g., information similar to that found in Appendix D of 1910.134), the rationale for medical evaluations (e.g., information similar to that found in American National Standards Institute (ANSI) Z88.6-2006), the contents of this exemption, and the requirement that the licensees will return to compliance within 90 days of the end of the PHE or December 31, 2020, whichever is sooner.

For an exemption from 10 CFR 20.1703(c)(6) the NRC may include conditions like:

  • The exemption applies only to personnel who had a fit-test within the past year (plus a 90-day grace period).

  • Affected wearers will be assigned only respirators that match the make, model, and size of the respirator facepiece with which they last performed their fit-test.

  • The exemption does not apply when an individual has experienced the following situations:

    • An obvious change in body weight;

    • Significant facial injury or scarring in the area of the tight-fitting respirator facepiece seal;

    • Significant dental changes (e.g., multiple extractions without prosthesis or acquisition of new dentures);

    • Reconstructive or cosmetic surgery in the area of the tight-fitting; respirator facepiece seal; or

    • Any other condition that might change the fit of the tight-fitting respirator.

  • All employees affected by this exemption will receive refresher training on donning their assigned respirator and will be informed of the rationale for respiratory fit-testing (e.g., information similar to that found in American National Standards Institute (ANSI Z88.10-2001), the contents of this exemption, and the requirement that the licensees will return to compliance within 90 days of the end of the PHE or December 31, 2020, whichever is sooner.

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7. How would the NRC ensure that licensees appropriately manage overdue respiratory protection medical evaluations and fit-tests during the period of exemption?

As noted in response to question 6, the NRC may impose conditions when granting an exemption. To ensure that licensees manage overdue medical evaluation and fit-tests, the NRC could condition an exemption to require a licensee to establish a temporary licensee-specific process for managing personnel with overdue medical evaluations and fit-tests. Further, NRC inspectors would have access to licensee site-specific documents related to the exemption, which would allow for periodic reviews of any issues concerning the use of respiratory protection.

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8. Will the NRC consider exemptions under this expedited-review process even where no workers at the site have tested positive for COVID-19?

Yes. Because this process is intended to help licensees prepare for and respond to the PHE by, among other things, supporting social distancing guidance, a confirmed case onsite is not necessary for the NRC to consider an exemption request under this expedited-review process.

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9. What if my situation doesn’t fall under the April 27, 2020 letter? Will the NRC provide expedited reviews for exemption requests that do not follow the process outlined in the April 27, 2020 letter?

Exemption requests that are not consistent with the process outlined in the April 27, 2020 letter should be submitted using the normal exemption-request process. Further, the NRC cannot guarantee expedited reviews for exemption requests that take a different approach from that outlined in the April 27, 2020 letter. The NRC will consider requests to expedite reviews of exemption requests that are not consistent with the April 27, 2020 letter on a case-by-case basis.

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10. Would a licensee seeking an exemption from 10 CFR 20.1703(c)(5)(iii) or 10 CFR 20.1703(c)(6) still need to perform parts of the respiratory radiological protection medical evaluation?

Yes. In general, as described in Regulatory Guide (RG) 8.15, Section 5.1.2 and 10 CFR 20.1703(c)(5) the medical evaluation requirements for the use of respiratory protection equipment can be completed by a trained licensee representative (e.g., registered nurse) reviewing a medical history screening questionnaire filled out by the wearer, these screening-type evaluations should not be impacted by the licensee’s COVID-19 response. However, some employees require periodic physical medical examinations at medical facilities (e.g., physician examination, spirometry, exercise stress test) to qualify to wear respiratory protection. For these cases, licensees can request an exemption under the expedited-review process noted in the April 27, 2020 letter after they have established a process where they collect a wearer’s medical history information per their existing plant-specific respiratory protection program (similar to 29 CFR 1910.134, Appendix C) and obtain the approval of a licensed physician, who has reviewed the wearer’s medical history, for the medical evaluation frequency extension, as described in RG 8.15, Section 5.1.

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11. What are the effective dates of the exemption?

Exemptions that are approved under this process will be in effect once the exemption is issued until 90 days after the end of the PHE, or until December 31, 2020. Licensees must come back into compliance with the regulations or receive approval for an additional exemption from the NRC before the expiration of the first exemption.

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12. What is the process for obtaining an extension of the initial exemption, if necessary?

The NRC will consider requests for extending the period of the exemption on a case-by-case basis.

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13. What is the NRC’s position on the use of dust masks at power reactor facilities?

In response to COVID-19, many licensees are providing respiratory protection devices to workers for use while on site. This is especially prevalent in situations where workers cannot satisfy prescribed social distancing or infection prevention recommendations. The device most commonly used for this purpose is a disposable respirator, often referred to as a "dust mask." In respiratory protection regulations, the dust mask is called a filtering facepiece and it can be found in several National Institute for Occupational Safety and Health categories (e.g., N95, N99, P95, R100).

In non-radiological applications, when filtering facepiece use is voluntary, whether the mask is provided by a licensee or the wearer, NRC licensees are relieved of the requirements to medically screen and fit-test the wearers. This situation falls within the authority of the Occupational Safety and Health Administration (OSHA) regulations at 29 CFR 1910.134(c). Licensees are required to ensure that the respirator itself will not create a hazard and to provide the wearer with the information contained in 29 CFR 1910.134, Appendix D. OSHA exempts filtering facepieces that are used on a voluntary basis from its requirements for a written respiratory protection program. However, if the licensee requires the filtering facepiece to be used, for non-radiological applications, licensees must follow all the applicable regulations of 29 CFR 1910.134(c), to include medical evaluation of the wearer and fit-testing.

If filtering facepieces are used to limit intakes of radioactive material the NRC regulation at 10 CFR Part 20, Appendix A, footnote d applies. Specifically, licensees may permit individuals to use this type of respirator who have not been medically screened or fit tested for the device provided that no credit be taken for their use in estimating intake or dose. All other respiratory protection program requirements listed in 10 CFR 20.1703 apply.

At present, there is a national supply shortage of N95 filtering facepiece respirators because of the Coronavirus Disease 2019 (COVID-19) outbreak. OSHA has published several enforcement discretion letters regarding the use of filtering facepiece respirators on their web site. Additionally, the U.S. Centers for Disease Control and Prevention (CDC) recently published recommendations regarding the use of cloth face coverings, especially for areas of significant community-based transmission of COVID-19. Cloth face coverings, similar to surgical masks, that form loose seals with facial surfaces are not respirators and thus are not covered by respiratory protection guidelines, but they can serve as effective barriers to the spread of the virus. NRC licensees can determine applications where cloth face coverings would be sufficiently effective at protecting workers in order to conserve N95 supplies.

Some licensees may want to release filtering facepiece respirators that have been worn inside radiologically controlled areas (RCAs) for future use in order to conserve supplies. If used inside of RCAs, it is possible that these respirators could become contaminated with licensed material as defined in 20.1003. A licensee is only allowed to dispose of licensed material per the methods described in 20.2001(a). To ensure that licensed material is not disposed of in violation of 20.2001(a), licensees typically conduct surveys of tools, equipment and personnel per 20.1501, as described in IE Circular No. 81-07, “Control of Radioactively Contaminated Material.” Therefore, licensees can release filtering facepiece respirators that have been worn inside the RCA if the respirator is subjected to an adequate radiological survey and determined to be free of licensed material.

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Page Last Reviewed/Updated Friday, June 12, 2020