ML20100D410
| ML20100D410 | |
| Person / Time | |
|---|---|
| Issue date: | 04/10/2020 |
| From: | Michael Layton NRC/NMSS/DMSST |
| To: | |
| Tapp K | |
| Shared Package | |
| ML20100D405 | List: |
| References | |
| Download: ML20100D410 (10) | |
Text
Medical Licensee Temporary Exemptions During the Emergency Caused by the COVID-19 Pandemic Completed by: Katie Tapp Date: 04/08/2020 Reviewed By: Lisa Dimmick Regu- Description of Exemption Safety Basis Exemption Language lation Subpart C - General Technical Requirements 35.60(b) The regulation from which [the The extension of calibration time For instrumentation that, in accordance with licensee] is requesting an does not constitute a significant the requirement in 10 CFR 35.60(b), is due exemption is the requirement in 10 increase to the risk of failure of to be calibrated between the date of this CFR 35.60(b) that the licensee these instruments or to public letter and [90 days after issuance], [the calibrate the instrumentation health and safety. The NRC staff licensee] is temporarily exempt from the required in 10 CFR 35.60(a) in notes that, absent the proposed calibration time interval required by 10 CFR accordance with nationally exemption, [additional staff 35.60(b). The licensee may instead extend recognized standards or the would be required to come into the required time interval for calibration of manufacturers instructions. (Note: the medical facilities the instrumentation by [the requested this exemption should only be increasing the possibility of extension, up to 90 days]. If the applied to instrumentation for which exposing licensees instrumentation exhibits signs that it might nationally recognized standards or employees, contractors, be malfunctioning, the licensee must manufacturers instructions require patients, or members of the suspend use of the instrumentation until it calibration at time intervals of a general public to the COVID-19 can be calibrated. This exemption does not month or longer. Exemptions from virus and/or the medical apply to any instrumentation for which
§ 35.60(b) should not be issued for facilities would not be able to nationally recognized standards or other instrumentation without provide patient care.] manufacturers instructions require further review. In addition, this Therefore, the NRC staff finds calibration more frequently than once per exemption should not be combined that the proposed exemption will month. In addition, this extension must not with extensions in calibrations not endanger life or property or be combined with extensions in calibrations intervals recommended by the common defense and intervals recommended by nationally nationally recognized standards security and is otherwise in the recognized standards due to the COVID-19 due to COVID-19 emergency.) public interest. emergency. Notwithstanding the regulatory relief provided by this exemption, the licensee should try to calibrate instrumentation as soon as is safely possible. [The licensee] requested to extend the required time interval for calibration during the emergency caused by the COVID-19 pandemic.
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Medical Licensee Temporary Exemptions During the Emergency Caused by the COVID-19 Pandemic Regu- Description of Exemption Safety Basis Exemption Language lation 35.61(a) The regulation from which [the The regulation in 10 CFR For instrumentation that, in accordance with licensee] is requesting an 35.61(a) requires licensees to the requirement in 10 CFR 35.61(a), is due exemption is the requirement in 10 calibrate survey instruments used to be calibrated between the date of this CFR 35.61(a) that the licensee to show compliance with 10 CFR letter and [90 days after issuance], [the calibrate survey instruments used Parts 20 and 35 before first use, licensee] is temporarily exempt from the to show compliance with 10 CFR annually, and following repair. calibration time interval required by 10 CFR Parts 20 and 35 annually. This exemption would only be 35.61(a) and may instead extend the from the requirement to perform required time interval for calibration of the annual calibrations, not to the instrumentation by [the requested requirement to perform extension, up to 90 days]. If the calibrations before first use and instrumentation exhibits signs that it might following repair. The extension be malfunctioning, the licensee must provided by this exemption is suspend use of the instrumentation until it relatively short compared to the can be calibrated. Notwithstanding the one-year time period between regulatory relief provided by this exemption, calibration of survey instruments. the licensee should try to calibrate This relatively short extension instrumentation as soon as is safely does not constitute a significant possible. [The licensee] requested to increase in risk to public health extend the time interval for calibration and safety. The NRC staff notes during the emergency caused by the that, absent the proposed COVID-19 pandemic.
exemption, [additional staff would be required to come into the medical facilities increasing the possibility of exposing licensees employees, contractors, patients, or members of the general public to the COVID-19 virus and/or the medical facilities would not be able to provide patient care.]
Therefore, the NRC staff finds 2
Medical Licensee Temporary Exemptions During the Emergency Caused by the COVID-19 Pandemic Regu- Description of Exemption Safety Basis Exemption Language lation that the proposed exemption will not endanger life or property or the common defense and security and is otherwise in the public interest.
35.67(b)(2) The regulation from which [the The extension provided by this For sealed sources or brachytherapy licensee] is requesting an exemption is relatively short. In sources that, in accordance with the exemption is the requirement in 10 addition, licensees must still requirement in 10 CFR 35.67(b)(2), are due CFR 35.67(b)(2) that the licensee perform leak tests if the sources to be leak tested between the date of this test sealed sources and exhibit signs that the source letter and [up to 90 days after issuance],
brachytherapy sources for leakage might be leaking, such as [the licensee] is temporarily exempt from at intervals not to exceed 6 months increased dose rates of the the requirements of 10 CFR 35.67(b)(2) at other intervals approved by the patient following procedures, and may instead extend the required time Commission or an Agreement which would indicate significant interval for leak testing of the sources by State in the Sealed Source and leakage. Therefore, this [the requested extension, up to 90 days].
Device Registry. exemption does not constitute a If the source exhibits signs that it might be significant increase in risk to malfunctioning, the licensee must suspend public health and safety. The use of the source until it can be leak tested.
NRC staff notes that, absent the Notwithstanding the regulatory relief proposed exemption, [additional provided by this exemption, the licensee staff would be required to should try to leak test sources as soon as is come into the medical facilities safely possible. [The licensee] requested increasing the possibility of to extend the leak test interval required by exposing licensees paragraph (b)(2) of this sectionfor employees, contractors, [brachytherapy and/or sealed sources]
patients, or members of the during the emergency caused by the general public to the COVID-19 COVID-19 pandemic.
virus and/or the medical facilities would not be able to provide patient care.]
Therefore, the NRC staff finds that the proposed exemption will not endanger life or property or the common defense and 3
Medical Licensee Temporary Exemptions During the Emergency Caused by the COVID-19 Pandemic Regu- Description of Exemption Safety Basis Exemption Language lation security and is otherwise in the public interest.
Subpart E - Unsealed Byproduct Material - WD Required 35.310(a) The regulation from which [the The relatively short period delay From the date of issuance of this letter until licensee] is requesting an of annual instruction does not [90 days after issuance], the licensee is exemption is the portion of 10 CFR constitute a significant increase in temporarily exempted from the requirement 35.310(a) that requires licensees to risk to public health and safety. in 10 CFR 35.310(a) that the licensee must provide radiation safety instruction The licensee must continue to provide annual instruction to personnel at least annually to personnel provide initial radiation safety caring for patients or human research caring for patients or human instruction to staff caring for subjects who cannot be released under 10 research subjects who cannot be patients or human research CFR 35.75. The purpose of this exemption released under 10 CFR 35.75. subjects who cannot be released. would be to allow [the licensee] to delay The NRC staff notes that, absent this annual instruction during the the proposed exemption, emergency caused by the COVID-19
[additional staff would be pandemic.
required to come into the medical facilities increasing the possibility of exposing licensees employees, contractors, patients, or members of the general public to the COVID-19 virus and/or the medical facilities would not be able to provide patient care.] Therefore, the NRC staff finds that the proposed exemption will not endanger life or property or the common defense and security and is otherwise in the public interest.
35.410(a) The regulation from which [the The relatively short period delay From the date of issuance of this letter until licensee] is requesting an of annual instruction does not [insert the date of the requested exemption is the portion of 10 CFR constitute a significant increase in extension, up to 90 days after issuance],
35.410(a) that requires licensees to risk to public health and safety. the licensee is temporarily exempted from 4
Medical Licensee Temporary Exemptions During the Emergency Caused by the COVID-19 Pandemic Regu- Description of Exemption Safety Basis Exemption Language lation provide radiation safety instruction The licensee must continue to the requirement in 10 CFR 35.410(a) that at least annually to personnel provide initial radiation safety the licensee must provide annual instruction caring for patients or human instruction to staff caring for to personnel caring for patients or human research subjects who cannot be patients or human research research subjects who cannot be released released under 10 CFR 35.75. subjects who cannot be released. under 10 CFR 35.75. The purpose of this The NRC staff notes that, absent exemption would be to allow [the licensee]
the proposed exemption, to delay this annual instruction during the
[additional staff would be emergency caused by the COVID-19 required to come into the pandemic.
medical facilities increasing the possibility of exposing licensees employees, contractors, patients, or members of the general public to the COVID-19 virus and/or the medical facilities would not be able to provide patient care.] Therefore, the NRC staff finds that the proposed exemption will not endanger life or property or the common defense and security and is otherwise in the public interest.
Subpart H - Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery (GSR) Units 35.610(d)( The regulation from which [the The relatively short period delay From the date of issuance of this letter until
- 2) licensee] is requesting an of annual instruction does not [90 days after issuance], the licensee is exemption is the portion of 10 CFR constitute a significant increase in temporarily exempted from the requirement 35.610(d)(2) that requires licensees risk to public health and safety. in 10 CFR 35.610(d)(2) that the licensee to provide operational and safety The licensee must continue to must provide operational and safety instructions at least annually to provide initial radiation safety instructions at least annually to individuals individuals who operate the unit at instruction to individuals who who operate the unit at the facility. The the facility. operate the unit at the facility and purpose of this exemption would be to allow must also continue to provide [the licensee] to delay this annual 5
Medical Licensee Temporary Exemptions During the Emergency Caused by the COVID-19 Pandemic Regu- Description of Exemption Safety Basis Exemption Language lation instruction in accordance with 10 instruction during the emergency caused by CFR 35.610(d)(1). The NRC the COVID-19 pandemic.
staff notes that, absent the proposed exemption, [additional staff would be required to come into the medical facilities increasing the possibility of exposing licensees employees, contractors, patients, or members of the general public to the COVID-19 virus and/or the medical facilities would not be able to provide patient care.]
Therefore, the NRC staff finds that the proposed exemption will not endanger life or property or the common defense and security and is otherwise in the public interest.
35.630(a) The regulation from which [the The requested extension is For systems that, in accordance with the licensee] is requesting an relatively short compared to the requirement in 10 CFR 35.630(a), are due exemption is the requirement in 10 2-year interval in paragraph (a)(1) to be calibrated between the date of this CFR 35.630(a) that the licensee or 4-year interval in paragraph letter and [90 days after issuance], [the perform calibration on the (a)(2) and does not constitute a licensee] is temporarily exempt from the 2-dosimetry system in accordance significant increase in risk to year and 4-year calibration time intervals with the conditions in paragraph public health and safety. Further, required by paragraphs (a)(1) and (a)(2),
(a)(1) or paragraph (a)(2). if the licensee chooses to respectively, and may instead extend the calibrate its systems in required time interval for calibration of the accordance with the conditions in system by [the requested extension, up 10 CFR 35.630(a)(1), then the to 90 days]. If the system exhibits signs requirement to perform that it might be malfunctioning, the licensee calibrations after any servicing must suspend use of the system until it can that may have affected system be calibrated. Notwithstanding the 6
Medical Licensee Temporary Exemptions During the Emergency Caused by the COVID-19 Pandemic Regu- Description of Exemption Safety Basis Exemption Language lation calibration will continue to apply. regulatory relief provided by this exemption, The NRC staff notes that, absent the licensee should try to calibrate the the proposed exemption, system as soon as is safely possible. [The
[additional staff would be licensee] requested to delay performance required to come into the of the calibration during the emergency medical facilities increasing caused by the COVID-19 pandemic.
the possibility of exposing licensees employees, contractors, patients, or members of the general public to the COVID-19 virus and/or the medical facilities would not be able to provide patient care.] Therefore, the NRC staff finds that the proposed exemption will not endanger life or property or the common defense and security and is otherwise in the public interest.
35.633(a)( The regulation from which [the The requested extension is For units that, in accordance with the
- 3) licensee] is requesting an relatively short compared to the 1 requirement in 10 CFR 35.633(a)(3), are exemption is the requirement in 10 quarter interval and does not due to be calibrated between the date of CFR 35.633(a)(3) that the licensee constitute a significant increase in this letter and [90 days after issuance],
perform calibration at intervals not risk to public health and safety. [the licensee] is temporarily exempt from exceeding 1 quarter for high dose- Further, the licensee will still be the calibration time interval required by 10 rate, medium dose-rate, and pulsed required to perform periodic spot CFR 35.633(a)(3) and may instead extend dose-rate remote afterloader units checks and full calibrations the required time interval for calibration of with sources whose half-life following replacement of sources the unit by [the requested extension, up exceeds 75 days. or any repairs in accordance with to 30 days]. If a unit exhibits signs that it 10 CFR 35.633(a)(2). The NRC might be malfunctioning, the licensee must staff notes that, absent the suspend use of the unit until it can be proposed exemption, [additional calibrated. Notwithstanding the regulatory staff would be required to relief provided by this exemption, the come into the medical facilities licensee should try to calibrate units as 7
Medical Licensee Temporary Exemptions During the Emergency Caused by the COVID-19 Pandemic Regu- Description of Exemption Safety Basis Exemption Language lation increasing the possibility of soon as is safely possible. [The licensee]
exposing licensees requested to delay performance of the employees, contractors, calibration during the emergency caused by patients, or members of the the COVID-19 pandemic.
general public to the COVID-19 virus and/or the medical facilities would not be able to provide patient care.]
Therefore, the NRC staff finds that the proposed exemption will not endanger life or property or the common defense and security and is otherwise in the public interest.
35.633(a)( The regulation from which [the The requested extension is For units that, in accordance with the
- 4) licensee] is requesting an relatively short compared to the requirement in 10 CFR 35.633(a)(4), are exemption is the requirement in 10 1-year interval and does not due to have a full calibration between the CFR 35.633(a)(4) that the licensee constitute a significant increase in date of this letter and [90 days after perform full calibration at intervals risk to public health and safety. issuance], [the licensee] is temporarily not exceeding 1 year for low dose- Further, the licensee will still be exempt from the full calibration time interval rate remote afterloader units. required to perform periodic spot required by 10 CFR 35.633(a)(4) and may checks and full calibrations instead extend the required time interval for following replacement of sources full calibration of the unit by [the requested or any repairs in accordance with extension, up to 90 days]. If a unit 10 CFR 35.633(a)(2). The NRC exhibits signs that it might be staff notes that, absent the malfunctioning, the licensee must suspend proposed exemption, [additional use of the unit until it can be fully calibrated.
staff would be required to Notwithstanding the regulatory relief come into the medical facilities provided by this exemption, the licensee increasing the possibility of should try to fully calibrate units as soon as exposing licensees is safely possible. [The licensee]
employees, contractors, requested to delay performance of the full patients, or members of the calibration during the emergency caused by general public to the COVID-19 the COVID-19 pandemic.
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Medical Licensee Temporary Exemptions During the Emergency Caused by the COVID-19 Pandemic Regu- Description of Exemption Safety Basis Exemption Language lation virus and/or the medical facilities would not be able to provide patient care.]
Therefore, the NRC staff finds that the proposed exemption will not endanger life or property or the common defense and security and is otherwise in the public interest.
35.635(a)( The regulation from which [the The requested extension is For units that, in accordance with the
- 3) licensee] is requesting an relatively short compared to the requirement in 10 CFR 35.635(a)(3), are exemption is the requirement in 10 1-year interval and does not due to have a full calibration between the CFR 35.635(a)(3) that the licensee constitute a significant increase in date of this letter and [90 days after perform full calibration at intervals risk to public health and safety. issuance], [the licensee] is temporarily not exceeding 1 year for gamma Further, the licensee will still be exempt from the calibration time interval stereotactic radiosurgery units. required to perform periodic spot required by 10 CFR 35.635(a)(3) and may
[The licensee] requested to delay checks and full calibrations as instead extend the required time interval for performance of the full calibration required by 10 CFR 35.635(a)(2). full calibration of the unit by [the requested by [requested extension] during The NRC staff notes that, absent extension, up to 90 days]. If a unit the emergency caused by the the proposed exemption, exhibits signs that it might be COVID-19 pandemic. [additional staff would be malfunctioning, the licensee must suspend required to come into the use of the unit until it can be fully calibrated.
medical facilities increasing Notwithstanding the regulatory relief the possibility of exposing provided by this exemption, the licensee licensees employees, should try to calibrate units as soon as is contractors, patients, or safely possible. [The licensee] requested members of the general public to delay performance of the full calibration to the COVID-19 virus and/or during the emergency caused by the the medical facilities would not COVID-19 pandemic.
be able to provide patient care.] Therefore, the NRC staff finds that the proposed exemption will not endanger life or property or the common 9
Medical Licensee Temporary Exemptions During the Emergency Caused by the COVID-19 Pandemic Regu- Description of Exemption Safety Basis Exemption Language lation defense and security and is otherwise in the public interest.
35.655(a) The regulation from which [the The requested extension is For units that, in accordance with the licensee] is requesting an relatively short compared to the requirement in 10 CFR 35.655(a), are due exemption is the requirement in 10 [5-year/7-year] interval and does to be inspected and serviced between the CFR 35.655(a) that the licensee not constitute a significant date of this letter and [90 days after shall have each [teletherapy increase in risk to public health issuance], [the licensee] is temporarily unit/gamma stereotactic unit] and safety. The NRC staff notes exempt from the inspection and service fully inspected and serviced at that, absent the proposed time interval required by 10 CFR 35.655(a) intervals not to exceed [5 years for exemption, [additional staff and may instead extend the required time each teletherapy unit/7 years for would be required to come into interval for calibration of the unit by [the each gamma stereotactic the medical facilities requested extension, up to 120 days]. If radiosurgery unit]. increasing the possibility of a unit exhibits signs that it might be exposing licensees malfunctioning, the licensee must suspend employees, contractors, use of the unit until it can be inspected and patients, or members of the serviced. Notwithstanding the regulatory general public to the COVID-19 relief provided by this exemption, the virus and/or the medical licensee should try to have the units facilities would not be able to inspected and serviced as soon as is safely provide patient care.] possible. [The licensee] requested to Therefore, the NRC staff finds delay performance of this inspection and that the proposed exemption will servicing during the emergency caused by not endanger life or property or the COVID-19 pandemic.
the common defense and security and is otherwise in the public interest.
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