The US Nuclear Regulatory Commission (NRC) issued a letter on April 27 to the Nuclear Energy Institute and the National Organization of Test, Research, and Training Reactors, and others, clarifying and expanding the guidance on respiratory protection requirements that it previously provided to stakeholders during an April 15 teleconference (on which we reported). Specifically, the NRC discussed ways in which licensees can request regulatory relief from requirements associated with medical evaluations and “fit testing” during the coronavirus (COVID-19) public health emergency (PHE).
NRC regulations at 10 CFR 20.1703(c)(5)(iii) and 10 CFR 20.1703(c)(6) require licensees to maintain a respiratory protection program that requires (1) a periodic—often annual—determination by a physician that the user is medically fit to use respiratory protection, and (2) annual “fit testing” to ensure that the licensee’s respiratory protection seals tightly to the licensee’s face. The Centers for Disease Control and Prevention (CDC) recently issued guidance in response to the COVID-19 PHE that, among other things, recommends that people avoid close contact with others.
The NRC developed criteria that licensees should address when applying for an expedited review of requests for exemption from the above periodicity requirements. This was done in an effort to ensure that the NRC’s medical evaluation and respiratory “fit testing” requirements do not result in licensees taking actions contrary to the CDC’s guidance by requiring licensees to come into close contact with the physician or individual performing the fit testing, and in recognition that 10 CFR 20.2301 allows the NRC to grant exemptions from its Part 20 regulations in certain circumstances.
Medical Evaluations
To receive expedited review of exemption requests from 10 CFR 20.1703(c)(5)(iii), licensees should submit a request that contains:
- 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 CDC’s 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 wearer’s 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:
- 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.
Licensees should submit exemption requests as required by applicable NRC regulations, and, in addition, are encouraged to send an email with the request to the licensee’s NRC project manager. 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. 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.
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 with the regulations in 10 CFR 20.1703(c).
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