ML20099G757

U.S. Nuclear Regulatory Commission Planned Actions Related to the Respiratory Protection Requirements for All Licensees During the Coronavirus Disease 2019 Public Health Emergency

ML20099G757
Person / Time
Issue date:	04/27/2020
From:	John Lubinski, Ho Nieh Office of Nuclear Material Safety and Safeguards, Office of Nuclear Reactor Regulation
To:	Bakken C, Moul D, Townsend C, Uhle J Entergy Nuclear, Nextera Energy, Nuclear Energy Institute
O'Banion M
References
Download: ML20099G757 (18)

Text

April 27, 2020 Dr. Jennifer L. Uhle Vice President, Generation & Suppliers Nuclear Energy Institute 1201 F Street, NW, Suite 1100 Washington, DC 20004

SUBJECT:

U.S. NUCLEAR REGULATORY COMMISSION PLANNED ACTIONS RELATED TO THE RESPIRATORY PROTECTION REQUIREMENTS FOR ALL LICENSEES DURING THE CORONAVIRUS DISEASE 2019 PUBLIC HEALTH EMERGENCY

Dear Dr. Uhle:

As you know, on January 31, 2020, the U.S. Department of Health and Human Services declared a public health emergency (PHE) for the United States to aid the nations healthcare community in responding to the Coronavirus Disease 2019 (COVID-19). On March 11, 2020, the COVID-19 outbreak was characterized as a pandemic by the World Health Organization.

As discussed during a public meeting held on March 20, 2020, with nuclear industry representatives and members of the public, this is an unprecedented time for our country, the U.S. Nuclear Regulatory Commission (NRC), and its regulated entities. In all of our actions, we are committed to following the NRCs Principles of Good Regulation (independence, openness, efficiency, clarity, and reliability) while performing our mission. In keeping with our principles, this letter provides information regarding the NRCs planned actions related to the requirements contained in Title 10 of the Code of Federal Regulations (CFR) Part 20 for respiratory protection during the COVID-19 PHE. This information is applicable to all NRC licensees.

Under the NRCs regulations in 10 CFR 20.2301, Applications for exemptions, The Commission may, upon application by a licensee or upon its own initiative, grant an exemption from the requirements of the regulations in this part if it determines the exemption is authorized by law and would not result in undue hazard to life or property. Consistent with this regulation and as described in this letter, the NRC is prepared to consider on an expedited basis requests for exemptions, upon request from individual licensees, 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). These exemptions would, if granted, facilitate the licensees implementation of these requirements in a manner that does not conflict with practices recommended by the Centers for Disease Control and Prevention (CDC) to limit the spread of COVID-19. 1 The NRC notes that the regulatory positions regarding respiratory protection-related medical evaluation and fit-testing frequencies in Regulatory Guide (RG) 8.15, Revision 1, Acceptable Programs for Respiratory Protection (Agencywide Documents Access and Management System Accession No. ML003739528) allow for the occasional application of 90-day grace periods from the due dates of these requirements. Licensees may take advantage of this flexibility without any additional action from the NRC. The exemption requests contemplated in this letter could, if 1 https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html

J. Uhle approved, allow licensees to go beyond the scope and duration of the grace periods contemplated in RG 8.15, Revision 1.

Requested Information Medical Evaluations: To receive expedited review of exemption requests from 10 CFR 20.1703(c)(5)(iii), licensees should submit a request that contains the following information:

• a statement that the licensee cannot meet the medical evaluation requirements of 10 CFR 20.1703(c)(5)(iii) without workers taking actions that may be contrary to CDCs guidance for responding to the COVID-19 PHE;

• a statement indicating whether the licensee would, for the duration of any exemption approved by NRC, apply a licensee-specific process to manage personnel with overdue medical evaluations, while ensuring the safety of its workers;

• an estimate of the number of personnel who would be covered by the exemption and their organizational positions, using generic position descriptions, that will be included in the licensee-specific process;

• the date and time when the exemption would be implemented, if approved, and when the licensee-specific process would take effect;

• a statement indicating whether this exemption would only be used by personnel having known, stable medical histories as determined and documented by a licensed physician;

• a statement that, except for physical medical examinations at medical facilities, the licensee has completed, or will complete within the required frequency (plus a 90-day grace period), all applicable respiratory protection program medical evaluation requirements (e.g., medical history questionnaire); and

• a statement that a licensed physician has reviewed the medical history questionnaire prior to the expiration of the current medical evaluation (plus a 90-day grace period) and has determined and documented that an extension of the wearers physical medical evaluation due date is acceptable such that the wearer remains qualified to use assigned respiratory protection equipment during the extension.

Fit-Testing Requirements: To receive expedited review of exemption requests from 10 CFR 20.1703(c)(6), licensees should submit a request that contains the following information:

• a statement that the licensee cannot meet the fit-testing requirements of 10 CFR 20.1703(c)(6) without workers taking actions that may be contrary to CDC guidance for responding to the COVID-19 PHE;

• a statement indicating whether the licensee would, for the duration of any exemption approved by the NRC, apply a licensee-specific process to manage personnel with overdue respiratory protection fit-tests, while ensuring the safety of its workers;

• an estimate of the number of personnel who would be covered by the exemption and their organizational positions, using generic position descriptions, that will be included in the licensee-specific process; and

• the date and time when the exemption would be implemented, if approved, and when the licensee-specific process would take effect.

In addition, the NRC can only ensure an expedited review of exemption requests from the medical evaluation and fit-testing requirements where the licensee-specific processes discussed above include a provision for informing workers of the general risks of wearing respiratory protection (e.g., information similar to that found in Appendix D of 29 CFR 1910.134), consistent

J. Uhle with the regulations in 10 CFR 20.1703(c). For fit-testing-related requests, the NRC would perform expedited reviews for those requests that do not include individuals with facial or other changes that could affect the fit of a respirator (e.g., information similar to that in RG 8.15, Section 5.3.5).

How to Submit Requests Licensees should make every effort to submit timely exemption requests. Licensees should continue to follow 10 CFR 20.1007, Communications, and 10 CFR 50.4, Written communications, or for 10 CFR Part 30, Part 40, Part 70, or Part 72, licensees should follow 10 CFR 30.6, Communications, 10 CFR 40.5, Communications, 10 CFR 70.5, Communications, or 10 CFR 72.4, Communications, as appropriate. To ensure timely receipt and review of these exemption requests, licensees should also send an email with the request to their facilitys NRC project manager, in addition to submitting the application as provided in NRC regulations.

Licensees should comply with the medical confidentiality provisions of the Americans with Disabilities Act and not include protected health information in any communication with the NRC.

Review Process The NRC will consider these requests on a case-by-case basis and, if the requirements for an exemption are met, will provide a written decision. Based upon its review, the NRC staff may condition any exemption approval, as appropriate. If sufficient time is not available for the NRC to provide a prior written decision for the exemption, then the NRC may provide a verbal decision that will be followed promptly with a letter documenting the approval or denial of the request.

Duration of Exemptions Exemptions that are approved under this process would be in effect until 90 days after the end of the PHE, or until December 31, 2020, whichever is sooner. Licensees must come back into compliance with the regulations or receive approval for an additional exemption period from the NRC before the end of each exemption period.

Alternative Approaches This letter does not preclude requests for exemptions that take a different approach or present different rationales. The NRC will review such requests on a case-by-case basis.

If you have any further questions about the contents of this letter, please contact your facilitys NRC project manager.

Paperwork Reduction Act Statement This letter contains voluntary guidance for implementing the voluntary information collections covered by 10 CFR Part 20 that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These information collections were approved by the Office of Management and Budget under control number 3150-0014. Estimated burden per response to

J. Uhle comply with this voluntary information collection request is 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. Send comments regarding this information collection to the Information Services Branch (T6-A10M), U.S. Nuclear Regulatory Commission, Washington, DC 20555 0001, or by e-mail to Infocollects.Resource@nrc.gov, and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202, (3150-0014) Office of Management and Budget, Washington, DC 20503.

Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document requesting or requiring the collection displays a currently valid Office of Management and Budget control number.

Sincerely, Sincerely, Digitally signed by Digitally signed by Ho K. Ho K. Nieh John W. John W. Lubinski Date: 2020.04.27 Date: 2020.04.27 Nieh 10:13:48 -04'00' Lubinski 09:55:51 -04'00' Ho K. Nieh, Director John W. Lubinski, Director Office of Nuclear Reactor Office of Nuclear Material Safety Regulation and Safeguards

SUBJECT:

U.S. NUCLEAR REGULATORY COMMISSION PLANNED ACTIONS RELATED TO THE RESPIRATORY PROTECTION REQUIREMENTS FOR ALL LICENSEES DURING THE CORONAVIRUS DISEASE 2019 PUBLIC HEALTH EMERGENCY DATED APRIL 27, 2020 Identical letters sent to:

Dr. Jennifer L. Uhle Vice President, Generation & Suppliers Nuclear Energy Institute 1201 F Street, NW, Suite 1100 Washington, DC 20004 Mr. Chris Bakken Executive Vice President Nuclear Operations & Chief Nuclear Officer Entergy Nuclear 1340 Echelon Parkway Jackson, MS 39213 Mr. Don Moul Executive Vice President, Nuclear Division and Chief Nuclear Officer Florida Power & Light Company Mail Stop: NT3/JW 15430 Endeavor Drive Jupiter, FL 33478 Mr. Clive Townsend Chair, National Organization of Test, Research, and Training Reactors 1611 Lionheart Ln West Lafayette, IN 47906

ML20099G757 *via email OFFICE NSIR/DRA/ARCB* NSIR/DRA/ARCB/BC* NRR/DORL/D* NRR/DRO/DD(A)*

NAME DGarmon KHsueh CErlanger MYoung DATE 4/16/2020 4/16/2020 4/16/2020 4/16/2020 OFFICE NRR/DRA/D* OE/D* OGC - NLO* NMSS/D*

NAME MFranovich GWilson TCampbell JLubinski DATE 4/16/2020 4/16/2020 4/20/2020 4/27/2020 OFFICE NRR/D*

NAME HNieh DATE 4/27/2020 April 27, 2020 Mr. Chris Bakken Executive Vice President Nuclear Operations & Chief Nuclear Officer Entergy Nuclear 1340 Echelon Parkway Jackson, MS 39213

SUBJECT:

U.S. NUCLEAR REGULATORY COMMISSION PLANNED ACTIONS RELATED TO THE RESPIRATORY PROTECTION REQUIREMENTS FOR ALL LICENSEES DURING THE CORONAVIRUS DISEASE 2019 PUBLIC HEALTH EMERGENCY

Dear Mr. Bakken:

As you know, on January 31, 2020, the U.S. Department of Health and Human Services declared a public health emergency (PHE) for the United States to aid the nations healthcare community in responding to the Coronavirus Disease 2019 (COVID-19). On March 11, 2020, the COVID-19 outbreak was characterized as a pandemic by the World Health Organization.

As discussed during a public meeting held on March 20, 2020, with nuclear industry representatives and members of the public, this is an unprecedented time for our country, the U.S. Nuclear Regulatory Commission (NRC), and its regulated entities. In all of our actions, we are committed to following the NRCs Principles of Good Regulation (independence, openness, efficiency, clarity, and reliability) while performing our mission. In keeping with our principles, this letter provides information regarding the NRCs planned actions related to the requirements contained in Title 10 of the Code of Federal Regulations (CFR) Part 20 for respiratory protection during the COVID-19 PHE. This information is applicable to all NRC licensees.

Under the NRCs regulations in 10 CFR 20.2301, Applications for exemptions, The Commission may, upon application by a licensee or upon its own initiative, grant an exemption from the requirements of the regulations in this part if it determines the exemption is authorized by law and would not result in undue hazard to life or property. Consistent with this regulation and as described in this letter, the NRC is prepared to consider on an expedited basis requests for exemptions, upon request from individual licensees, 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). These exemptions would, if granted, facilitate the licensees implementation of these requirements in a manner that does not conflict with practices recommended by the Centers for Disease Control and Prevention (CDC) to limit the spread of COVID-19. 1 The NRC notes that the regulatory positions regarding respiratory protection-related medical evaluation and fit-testing frequencies in Regulatory Guide (RG) 8.15, Revision 1, Acceptable Programs for Respiratory Protection (Agencywide Documents Access and Management System Accession No. ML003739528) allow for the occasional application of 90-day grace periods from the due dates of these requirements. Licensees may take advantage of this flexibility without any additional action from the NRC. The exemption requests contemplated in this letter could, if 1 https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html

C. Bakken approved, allow licensees to go beyond the scope and duration of the grace periods contemplated in RG 8.15, Revision 1.

Requested Information Medical Evaluations: To receive expedited review of exemption requests from 10 CFR 20.1703(c)(5)(iii), licensees should submit a request that contains the following information:

• a statement that the licensee cannot meet the medical evaluation requirements of 10 CFR 20.1703(c)(5)(iii) without workers taking actions that may be contrary to CDCs guidance for responding to the COVID-19 PHE;

• a statement indicating whether the licensee would, for the duration of any exemption approved by NRC, apply a licensee-specific process to manage personnel with overdue medical evaluations, while ensuring the safety of its workers;

• an estimate of the number of personnel who would be covered by the exemption and their organizational positions, using generic position descriptions, that will be included in the licensee-specific process;

• the date and time when the exemption would be implemented, if approved, and when the licensee-specific process would take effect;

• a statement indicating whether this exemption would only be used by personnel having known, stable medical histories as determined and documented by a licensed physician;

• a statement that, except for physical medical examinations at medical facilities, the licensee has completed, or will complete within the required frequency (plus a 90-day grace period), all applicable respiratory protection program medical evaluation requirements (e.g., medical history questionnaire); and

• a statement that a licensed physician has reviewed the medical history questionnaire prior to the expiration of the current medical evaluation (plus a 90-day grace period) and has determined and documented that an extension of the wearers physical medical evaluation due date is acceptable such that the wearer remains qualified to use assigned respiratory protection equipment during the extension.

Fit-Testing Requirements: To receive expedited review of exemption requests from 10 CFR 20.1703(c)(6), licensees should submit a request that contains the following information:

• a statement that the licensee cannot meet the fit-testing requirements of 10 CFR 20.1703(c)(6) without workers taking actions that may be contrary to CDC guidance for responding to the COVID-19 PHE;

• a statement indicating whether the licensee would, for the duration of any exemption approved by the NRC, apply a licensee-specific process to manage personnel with overdue respiratory protection fit-tests, while ensuring the safety of its workers;

• an estimate of the number of personnel who would be covered by the exemption and their organizational positions, using generic position descriptions, that will be included in the licensee-specific process; and

• the date and time when the exemption would be implemented, if approved, and when the licensee-specific process would take effect.

In addition, the NRC can only ensure an expedited review of exemption requests from the medical evaluation and fit-testing requirements where the licensee-specific processes discussed above include a provision for informing workers of the general risks of wearing respiratory protection (e.g., information similar to that found in Appendix D of 29 CFR 1910.134), consistent

C. Bakken with the regulations in 10 CFR 20.1703(c). For fit-testing-related requests, the NRC would perform expedited reviews for those requests that do not include individuals with facial or other changes that could affect the fit of a respirator (e.g., information similar to that in RG 8.15, Section 5.3.5).

How to Submit Requests Licensees should make every effort to submit timely exemption requests. Licensees should continue to follow 10 CFR 20.1007, Communications, and 10 CFR 50.4, Written communications, or for 10 CFR Part 30, Part 40, Part 70, or Part 72, licensees should follow 10 CFR 30.6, Communications, 10 CFR 40.5, Communications, 10 CFR 70.5, Communications, or 10 CFR 72.4, Communications, as appropriate. To ensure timely receipt and review of these exemption requests, licensees should also send an email with the request to their facilitys NRC project manager, in addition to submitting the application as provided in NRC regulations.

Licensees should comply with the medical confidentiality provisions of the Americans with Disabilities Act and not include protected health information in any communication with the NRC.

Review Process The NRC will consider these requests on a case-by-case basis and, if the requirements for an exemption are met, will provide a written decision. Based upon its review, the NRC staff may condition any exemption approval, as appropriate. If sufficient time is not available for the NRC to provide a prior written decision for the exemption, then the NRC may provide a verbal decision that will be followed promptly with a letter documenting the approval or denial of the request.

Duration of Exemptions Exemptions that are approved under this process would be in effect until 90 days after the end of the PHE, or until December 31, 2020, whichever is sooner. Licensees must come back into compliance with the regulations or receive approval for an additional exemption period from the NRC before the end of each exemption period.

Alternative Approaches This letter does not preclude requests for exemptions that take a different approach or present different rationales. The NRC will review such requests on a case-by-case basis.

If you have any further questions about the contents of this letter, please contact your facilitys NRC project manager.

Paperwork Reduction Act Statement This letter contains voluntary guidance for implementing the voluntary information collections covered by 10 CFR Part 20 that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These information collections were approved by the Office of Management and Budget under control number 3150-0014. Estimated burden per response to

C. Bakken comply with this voluntary information collection request is 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. Send comments regarding this information collection to the Information Services Branch (T6-A10M), U.S. Nuclear Regulatory Commission, Washington, DC 20555 0001, or by e-mail to Infocollects.Resource@nrc.gov, and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202, (3150-0014) Office of Management and Budget, Washington, DC 20503.

Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document requesting or requiring the collection displays a currently valid Office of Management and Budget control number.

Sincerely, Sincerely, Digitally signed by Digitally signed by Ho K. Ho K. Nieh John W. John W. Lubinski Date: 2020.04.27 Date: 2020.04.27 Nieh 10:14:17 -04'00' Lubinski 09:56:24 -04'00' Ho K. Nieh, Director John W. Lubinski, Director Office of Nuclear Reactor Office of Nuclear Material Safety Regulation and Safeguards

April 27, 2020 Mr. Don Moul Executive Vice President, Nuclear Division and Chief Nuclear Officer Florida Power & Light Company Mail Stop: NT3/JW 15430 Endeavor Drive Jupiter, FL 33478

SUBJECT:

U.S. NUCLEAR REGULATORY COMMISSION PLANNED ACTIONS RELATED TO THE RESPIRATORY PROTECTION REQUIREMENTS FOR ALL LICENSEES DURING THE CORONAVIRUS DISEASE 2019 PUBLIC HEALTH EMERGENCY

Dear Mr. Moul:

As you know, on January 31, 2020, the U.S. Department of Health and Human Services declared a public health emergency (PHE) for the United States to aid the nations healthcare community in responding to the Coronavirus Disease 2019 (COVID-19). On March 11, 2020, the COVID-19 outbreak was characterized as a pandemic by the World Health Organization.

As discussed during a public meeting held on March 20, 2020, with nuclear industry representatives and members of the public, this is an unprecedented time for our country, the U.S. Nuclear Regulatory Commission (NRC), and its regulated entities. In all of our actions, we are committed to following the NRCs Principles of Good Regulation (independence, openness, efficiency, clarity, and reliability) while performing our mission. In keeping with our principles, this letter provides information regarding the NRCs planned actions related to the requirements contained in Title 10 of the Code of Federal Regulations (CFR) Part 20 for respiratory protection during the COVID-19 PHE. This information is applicable to all NRC licensees.

Under the NRCs regulations in 10 CFR 20.2301, Applications for exemptions, The Commission may, upon application by a licensee or upon its own initiative, grant an exemption from the requirements of the regulations in this part if it determines the exemption is authorized by law and would not result in undue hazard to life or property. Consistent with this regulation and as described in this letter, the NRC is prepared to consider on an expedited basis requests for exemptions, upon request from individual licensees, 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). These exemptions would, if granted, facilitate the licensees implementation of these requirements in a manner that does not conflict with practices recommended by the Centers for Disease Control and Prevention (CDC) to limit the spread of COVID-19. 1 The NRC notes that the regulatory positions regarding respiratory protection-related medical evaluation and fit-testing frequencies in Regulatory Guide (RG) 8.15, Revision 1, Acceptable Programs for Respiratory Protection (Agencywide Documents Access and Management System Accession No. ML003739528) allow for the occasional application of 90-day grace periods from the due dates of these requirements. Licensees may take advantage of this flexibility without any additional action from the NRC. The exemption requests contemplated in this letter could, if 1 https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html

D. Moul approved, allow licensees to go beyond the scope and duration of the grace periods contemplated in RG 8.15, Revision 1.

Requested Information Medical Evaluations: To receive expedited review of exemption requests from 10 CFR 20.1703(c)(5)(iii), licensees should submit a request that contains the following information:

• a statement that the licensee cannot meet the medical evaluation requirements of 10 CFR 20.1703(c)(5)(iii) without workers taking actions that may be contrary to CDCs guidance for responding to the COVID-19 PHE;

• a statement indicating whether the licensee would, for the duration of any exemption approved by NRC, apply a licensee-specific process to manage personnel with overdue medical evaluations, while ensuring the safety of its workers;

• an estimate of the number of personnel who would be covered by the exemption and their organizational positions, using generic position descriptions, that will be included in the licensee-specific process;

• the date and time when the exemption would be implemented, if approved, and when the licensee-specific process would take effect;

• a statement indicating whether this exemption would only be used by personnel having known, stable medical histories as determined and documented by a licensed physician;

• a statement that, except for physical medical examinations at medical facilities, the licensee has completed, or will complete within the required frequency (plus a 90-day grace period), all applicable respiratory protection program medical evaluation requirements (e.g., medical history questionnaire); and

• a statement that a licensed physician has reviewed the medical history questionnaire prior to the expiration of the current medical evaluation (plus a 90-day grace period) and has determined and documented that an extension of the wearers physical medical evaluation due date is acceptable such that the wearer remains qualified to use assigned respiratory protection equipment during the extension.

Fit-Testing Requirements: To receive expedited review of exemption requests from 10 CFR 20.1703(c)(6), licensees should submit a request that contains the following information:

• a statement that the licensee cannot meet the fit-testing requirements of 10 CFR 20.1703(c)(6) without workers taking actions that may be contrary to CDC guidance for responding to the COVID-19 PHE;

• a statement indicating whether the licensee would, for the duration of any exemption approved by the NRC, apply a licensee-specific process to manage personnel with overdue respiratory protection fit-tests, while ensuring the safety of its workers;

• an estimate of the number of personnel who would be covered by the exemption and their organizational positions, using generic position descriptions, that will be included in the licensee-specific process; and

• the date and time when the exemption would be implemented, if approved, and when the licensee-specific process would take effect.

In addition, the NRC can only ensure an expedited review of exemption requests from the medical evaluation and fit-testing requirements where the licensee-specific processes discussed above include a provision for informing workers of the general risks of wearing respiratory protection (e.g., information similar to that found in Appendix D of 29 CFR 1910.134), consistent

D. Moul with the regulations in 10 CFR 20.1703(c). For fit-testing-related requests, the NRC would perform expedited reviews for those requests that do not include individuals with facial or other changes that could affect the fit of a respirator (e.g., information similar to that in RG 8.15, Section 5.3.5).

How to Submit Requests Licensees should make every effort to submit timely exemption requests. Licensees should continue to follow 10 CFR 20.1007, Communications, and 10 CFR 50.4, Written communications, or for 10 CFR Part 30, Part 40, Part 70, or Part 72, licensees should follow 10 CFR 30.6, Communications, 10 CFR 40.5, Communications, 10 CFR 70.5, Communications, or 10 CFR 72.4, Communications, as appropriate. To ensure timely receipt and review of these exemption requests, licensees should also send an email with the request to their facilitys NRC project manager, in addition to submitting the application as provided in NRC regulations.

Licensees should comply with the medical confidentiality provisions of the Americans with Disabilities Act and not include protected health information in any communication with the NRC.

Review Process The NRC will consider these requests on a case-by-case basis and, if the requirements for an exemption are met, will provide a written decision. Based upon its review, the NRC staff may condition any exemption approval, as appropriate. If sufficient time is not available for the NRC to provide a prior written decision for the exemption, then the NRC may provide a verbal decision that will be followed promptly with a letter documenting the approval or denial of the request.

Duration of Exemptions Exemptions that are approved under this process would be in effect until 90 days after the end of the PHE, or until December 31, 2020, whichever is sooner. Licensees must come back into compliance with the regulations or receive approval for an additional exemption period from the NRC before the end of each exemption period.

Alternative Approaches This letter does not preclude requests for exemptions that take a different approach or present different rationales. The NRC will review such requests on a case-by-case basis.

If you have any further questions about the contents of this letter, please contact your facilitys NRC project manager.

Paperwork Reduction Act Statement This letter contains voluntary guidance for implementing the voluntary information collections covered by 10 CFR Part 20 that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These information collections were approved by the Office of Management and Budget under control number 3150-0014. Estimated burden per response to

D. Moul comply with this voluntary information collection request is 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. Send comments regarding this information collection to the Information Services Branch (T6-A10M), U.S. Nuclear Regulatory Commission, Washington, DC 20555 0001, or by e-mail to Infocollects.Resource@nrc.gov, and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202, (3150-0014) Office of Management and Budget, Washington, DC 20503.

Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document requesting or requiring the collection displays a currently valid Office of Management and Budget control number.

Sincerely, Sincerely, Digitally signed Digitally signed by Ho K. by Ho K. Nieh John W. John W. Lubinski Date: 2020.04.27 Date: 2020.04.27 Nieh 10:14:50 -04'00' Lubinski 09:57:05 -04'00' Ho K. Nieh, Director John W. Lubinski, Director Office of Nuclear Reactor Office of Nuclear Material Safety Regulation and Safeguards

April 27, 2020 Mr. Clive Townsend Chair, National Organization of Test, Research, and Training Reactors 1611 Lionheart Ln West Lafayette, IN 47906

SUBJECT:

U.S. NUCLEAR REGULATORY COMMISSION PLANNED ACTIONS RELATED TO THE RESPIRATORY PROTECTION REQUIREMENTS FOR ALL LICENSEES DURING THE CORONAVIRUS DISEASE 2019 PUBLIC HEALTH EMERGENCY

Dear Mr. Townsend:

As you know, on January 31, 2020, the U.S. Department of Health and Human Services declared a public health emergency (PHE) for the United States to aid the nations healthcare community in responding to the Coronavirus Disease 2019 (COVID-19). On March 11, 2020, the COVID-19 outbreak was characterized as a pandemic by the World Health Organization.

As discussed during a public meeting held on March 20, 2020, with nuclear industry representatives and members of the public, this is an unprecedented time for our country, the U.S. Nuclear Regulatory Commission (NRC), and its regulated entities. In all of our actions, we are committed to following the NRCs Principles of Good Regulation (independence, openness, efficiency, clarity, and reliability) while performing our mission. In keeping with our principles, this letter provides information regarding the NRCs planned actions related to the requirements contained in Title 10 of the Code of Federal Regulations (CFR) Part 20 for respiratory protection during the COVID-19 PHE. This information is applicable to all NRC licensees.

Under the NRCs regulations in 10 CFR 20.2301, Applications for exemptions, The Commission may, upon application by a licensee or upon its own initiative, grant an exemption from the requirements of the regulations in this part if it determines the exemption is authorized by law and would not result in undue hazard to life or property. Consistent with this regulation and as described in this letter, the NRC is prepared to consider on an expedited basis requests for exemptions, upon request from individual licensees, 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). These exemptions would, if granted, facilitate the licensees implementation of these requirements in a manner that does not conflict with practices recommended by the Centers for Disease Control and Prevention (CDC) to limit the spread of COVID-19. 1 The NRC notes that the regulatory positions regarding respiratory protection-related medical evaluation and fit-testing frequencies in Regulatory Guide (RG) 8.15, Revision 1, Acceptable Programs for Respiratory Protection (Agencywide Documents Access and Management System Accession No. ML003739528) allow for the occasional application of 90-day grace periods from the due dates of these requirements. Licensees may take advantage of this flexibility without any additional action from the NRC. The exemption requests contemplated in this letter could, if 1 https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html

C. Townsend approved, allow licensees to go beyond the scope and duration of the grace periods contemplated in RG 8.15, Revision 1.

Requested Information Medical Evaluations: To receive expedited review of exemption requests from 10 CFR 20.1703(c)(5)(iii), licensees should submit a request that contains the following information:

• a statement that the licensee cannot meet the medical evaluation requirements of 10 CFR 20.1703(c)(5)(iii) without workers taking actions that may be contrary to CDCs guidance for responding to the COVID-19 PHE;

• a statement indicating whether the licensee would, for the duration of any exemption approved by NRC, apply a licensee-specific process to manage personnel with overdue medical evaluations, while ensuring the safety of its workers;

• an estimate of the number of personnel who would be covered by the exemption and their organizational positions, using generic position descriptions, that will be included in the licensee-specific process;

• the date and time when the exemption would be implemented, if approved, and when the licensee-specific process would take effect;

• a statement indicating whether this exemption would only be used by personnel having known, stable medical histories as determined and documented by a licensed physician;

• a statement that, except for physical medical examinations at medical facilities, the licensee has completed, or will complete within the required frequency (plus a 90-day grace period), all applicable respiratory protection program medical evaluation requirements (e.g., medical history questionnaire); and

• a statement that a licensed physician has reviewed the medical history questionnaire prior to the expiration of the current medical evaluation (plus a 90-day grace period) and has determined and documented that an extension of the wearers physical medical evaluation due date is acceptable such that the wearer remains qualified to use assigned respiratory protection equipment during the extension.

Fit-Testing Requirements: To receive expedited review of exemption requests from 10 CFR 20.1703(c)(6), licensees should submit a request that contains the following information:

• a statement that the licensee cannot meet the fit-testing requirements of 10 CFR 20.1703(c)(6) without workers taking actions that may be contrary to CDC guidance for responding to the COVID-19 PHE;

• a statement indicating whether the licensee would, for the duration of any exemption approved by the NRC, apply a licensee-specific process to manage personnel with overdue respiratory protection fit-tests, while ensuring the safety of its workers;

• an estimate of the number of personnel who would be covered by the exemption and their organizational positions, using generic position descriptions, that will be included in the licensee-specific process; and

• the date and time when the exemption would be implemented, if approved, and when the licensee-specific process would take effect.

In addition, the NRC can only ensure an expedited review of exemption requests from the medical evaluation and fit-testing requirements where the licensee-specific processes discussed above include a provision for informing workers of the general risks of wearing respiratory protection (e.g., information similar to that found in Appendix D of 29 CFR 1910.134), consistent

C. Townsend with the regulations in 10 CFR 20.1703(c). For fit-testing-related requests, the NRC would perform expedited reviews for those requests that do not include individuals with facial or other changes that could affect the fit of a respirator (e.g., information similar to that in RG 8.15, Section 5.3.5).

How to Submit Requests Licensees should make every effort to submit timely exemption requests. Licensees should continue to follow 10 CFR 20.1007, Communications, and 10 CFR 50.4, Written communications, or for 10 CFR Part 30, Part 40, Part 70, or Part 72, licensees should follow 10 CFR 30.6, Communications, 10 CFR 40.5, Communications, 10 CFR 70.5, Communications, or 10 CFR 72.4, Communications, as appropriate. To ensure timely receipt and review of these exemption requests, licensees should also send an email with the request to their facilitys NRC project manager, in addition to submitting the application as provided in NRC regulations.

Licensees should comply with the medical confidentiality provisions of the Americans with Disabilities Act and not include protected health information in any communication with the NRC.

Review Process The NRC will consider these requests on a case-by-case basis and, if the requirements for an exemption are met, will provide a written decision. Based upon its review, the NRC staff may condition any exemption approval, as appropriate. If sufficient time is not available for the NRC to provide a prior written decision for the exemption, then the NRC may provide a verbal decision that will be followed promptly with a letter documenting the approval or denial of the request.

Duration of Exemptions Exemptions that are approved under this process would be in effect until 90 days after the end of the PHE, or until December 31, 2020, whichever is sooner. Licensees must come back into compliance with the regulations or receive approval for an additional exemption period from the NRC before the end of each exemption period.

Alternative Approaches This letter does not preclude requests for exemptions that take a different approach or present different rationales. The NRC will review such requests on a case-by-case basis.

If you have any further questions about the contents of this letter, please contact your facilitys NRC project manager.

Paperwork Reduction Act Statement This letter contains voluntary guidance for implementing the voluntary information collections covered by 10 CFR Part 20 that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These information collections were approved by the Office of Management and Budget under control number 3150-0014. Estimated burden per response to

C. Townsend comply with this voluntary information collection request is 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. Send comments regarding this information collection to the Information Services Branch (T6-A10M), U.S. Nuclear Regulatory Commission, Washington, DC 20555 0001, or by e-mail to Infocollects.Resource@nrc.gov, and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202, (3150-0014) Office of Management and Budget, Washington, DC 20503.

Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document requesting or requiring the collection displays a currently valid Office of Management and Budget control number.

Sincerely, Sincerely, Digitally signed Digitally signed by Ho K. by Ho K. Nieh John W. John W. Lubinski Date: 2020.04.27 Date: 2020.04.27 Nieh 10:15:38 -04'00' Lubinski 09:57:30 -04'00' Ho K. Nieh, Director John W. Lubinski, Director Office of Nuclear Reactor Office of Nuclear Material Safety Regulation and Safeguards