ML20122A253
| ML20122A253 | |
| Person / Time | |
|---|---|
| Issue date: | 05/14/2020 |
| From: | Sarah Lopas NRC/NMSS/DMSST/MSEB |
| To: | Duane White Office of Nuclear Material Safety and Safeguards |
| Sarah Lopas 415-6360 | |
| References | |
| Download: ML20122A253 (11) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 May 14, 2020 MEMORANDUM TO: Duane E. White, Acting Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards FROM: Sarah L. Lopas, Project Manager Medical Safety and Events Assessment Branch Sarah Digitally signed by Sarah Lopas Lopas Date: 2020.05.14 Division of Materials Safety, Security, State, 14:19:22 -04'00' and Tribal Programs Office of Nuclear Material Safety and Safeguards
SUBJECT:
SUMMARY
OF APRIL 22, 2020, U.S. NUCLEAR REGULATORY COMMISSION MEETING TO DISCUSS TEMPORARY REGULATORY RELIEF FOR MEDICAL LICENSEES DURING THE COVID-19 PUBLIC HEALTH EMERGENCY Meeting Identifier: 20200417 Date of Meeting: Wednesday, April 22, 2020; 2:00 p.m. EDT Location: Webinar with Moderated Bridge Line Type of Meeting: Category 3 Purpose of the Meeting: To discuss how U.S. Nuclear Regulatory Commission (NRC) medical licensees can request temporary regulatory relief during the COVID-19 public health emergency (PHE) through submission of certain exemption requests, and to solicit feedback from medical licensees regarding expected exemptions.
General Details: On January 31, 2020, the U.S. Department of Health and Human Services declared a PHE for the United States to aid the nations healthcare community in responding to the Coronavirus disease (COVID-19). The NRC recognizes that during the current COVID-19 PHE, licensees may experience challenges in meeting certain regulatory requirements. On April 7, 2020, the NRC issued a letter to its byproduct material, uranium recovery, decommissioning, fuel cycle, and spent fuel storage licensees that outlined options to seek regulatory relief that may be necessary during the COVID-19 PHE. This letter is available in the NRCs Agencywide Documents Access and Management System (ADAMS) at Accession No. ML20094G166.
To follow up on the April 7 regulatory relief letter, the NRCs Medical Radiation Safety Team held a public meeting with licensees under 10 CFR Part 35, Medical Use of Byproduct Material, on April 22, 2020. The meeting was conducted remotely through use of webinar and
April 22, 2020 Meeting Summary ML20122A253 an operator-moderated bridge line. The NRC published the official public meeting notice on April 16, 2020, providing webinar registration and bridge line instructions for attendees (ADAMS Accession No. ML20113E808).
The meeting began at 2:00 p.m. EDT with a 25-minute presentation by NRC staff on regulatory relief pathways and the processes by which medical licensees can request temporary regulatory exemptions. This information is fully detailed in the April 7, 2020 licensee letter cited above, however, key points from the staffs presentation included:
- Licensees can e-mail requests for temporary exemptions from certain regulatory requirements to the directors of the NRCs regional Divisions of Nuclear Materials Safety: James.Trapp@nrc.gov for Region I; David.Pelton@nrc.gov for Region III; and Mary.Muessle@nrc.gov for Region IV.
- Licensees can call or e-mail their facility project manager to request emergency exemption requests. In urgent, off-hours cases, licensees can call the NRCs Headquarters Operations Officer at (301) 816-5100.
- The NRC is evaluating the need for an enforcement guidance memorandum that would authorize inspectors to use discretion not to cite certain violations of requirements when specified criteria are met.
- To facilitate efficient review, COVID-19 PHE exemption requests should include descriptions of: activities and parts of the facility that are shut down or where access is limited; parts of the facility that are operational; regulations, license conditions, or commitments for which the licensee is seeking temporary relief; compensatory measures to ensure material is being safely stored and used; and length of time exemption is required and actions that will be taken when re-start occurs.
- Agreement States are handling their COVID-19 responses individually; Agreement State licensees should contact their State regulatory agency regarding potential relief pathways.
The staffs slide presentation is available in ADAMS at Accession No. ML20111A042. During the presentation, the staff cited a table with a preliminary list of potential exemptions that medical licensees may need during the COVID-19 PHE. This table was developed to provide template language for the NRCs regional Divisions of Nuclear Materials Safety language to process exemption requests for specific situations that the NRCs Medical Radiation Safety Team has already evaluated. Licensees may find the template language helpful in the development of their exemption requests but should note that they can request exemptions for other situations for which they may need temporary regulatory relief. This table is available at ADAMS Accession No. ML20129K060 and is included as Enclosure 1. The table of temporary exemptions will be updated as the NRC processes exemption requests. The most up-to-date version of the table will be maintained on the NRCs Medical Licensee Toolkit at https://www.nrc.gov/materials/miau/med-use-toolkit.html, in the Related Information box on the right-hand side of the page.
Following the staffs presentation, the meeting was then opened to receive public comments and questions. Approximately 388 people participated in the meeting, of which 323 logged into the webinar. A list of NRC meeting participants is included as Enclosure 2. The meeting concluded at 3:55 p.m. EDT. The staff has summarized the comments and questions below.
April 22, 2020 Meeting Summary ML20122A253 Summary of Comments Received:
Exemption Submission Process An NRC regional staff member asked that NRC staff clarify what is meant by a written request, for example, could this be an e-mail or did the NRC need a signed letter? NRC staff responded that an e-mail was acceptable as a written request. NRC staff clarified that the e-mail did not need to include an official request letter attached to the e-mail, and that request information could be contained in the body of the e-mail.
A follow-up process question asked whether licensees could submit a package of multiple requests or whether requests needed to be submitted separately. NRC staff answered that a single e-mail containing multiple exemption requests was acceptable. NRC staff also noted that a single e-mail could contain requests for multiple licensees. Another commenter asked if the NRC had considered grouping commonly requested exemptions so licensees could request exemptions by group instead of by individual regulations. NRC staff said they had not done this as it could be difficult to group exemptions due to differences across licensees. NRC staff also noted that requests should articulate the safety significance for each requested exemption, and that grouping exemptions could make that difficult.
Other process questions included clarification on who the requests were going to and how long they would take for processing. NRC staff clarified that all requests should be e-mailed to the NRC regional directors for the Divisions of Nuclear Material Safety, and that these division directors were distributing requests to their staff. Temporary exemption requests should be sent to James.Trapp@nrc.gov in NRC Region I, David.Pelton@nrc.gov in NRC Region III, and Mary.Muessle@nrc.gov in NRC Region IV. NRC staff said that to date, exemption requests were taking a few days to process. However, unanticipated exemptions may take longer to process. An NRC staff member noted that in order to maximize efficiencies, licensees should closely follow the template language in the NRCs table of potential exemptions (ADAMS Accession No. ML20129K060).
A question was asked regarding the timeframe of exemptions, and whether the 90 days used in the NRCs table of potential exemptions was a strict number. NRC staff responded that 90 days was not strict but what has previously been evaluated. Staff noted that due to the evolving PHE, licensees could submit requests for longer than 90 days with an appropriate safety basis.
The staff also noted that for some requirements, such as calibration or self-servicing, the exemption would be 90 days from the required due date. Another commenter asked whether licensees would need to submit an exemption extension request if the initial requested timeframe was not long enough, citing the possibility of staff furloughs impacting future facility operations. NRC staff confirmed that yes, if an extension to an exemption is needed, licensees must submit an extension request with that supporting information. Another commenter asked how long certain training could be delayed, such as radiation worker refresher training and general awareness training. NRC staff answered that this would vary by licensee and that licensees need to be specific in their requests regarding their needs.
A commenter asked whether exemptions would be retroactive, or would they only apply going forward from the date of approval. NRC staff answered that no, exemptions are not applied retroactively, and any violations prior to the exemption would be subject to the NRCs enforcement manual (ADAMS Accession No. ML19274C228).
April 22, 2020 Meeting Summary ML20122A253 A commenter asked if there was a Web site where the public could see how the NRC is evaluating exemption requests, and whether the Web site would also list rejected exemptions.
NRC staff answered that the public can view approved exemptions for materials licensees at the NRCs COVID-19 response Web site at https://www.nrc.gov/about-nrc/covid-19/materials/med-indust-academic.html. NRC staff was uncertain about whether the Web site would also include rejected exemptions, and that as of April 22, no exemptions had yet been rejected. NRC staff said that if they are unable to initially approve an exemption request, they ask the licensee for additional supporting information in order to further evaluate the request.
Suggested Areas of Exemptions A commenter stated that the most dangerous thing a patient can do if he does not have COVID-19 is to go to a hospital filled with patients infected with the virus. The commenter urged that steps should be taken to keep non-COVID-19 patients out of the hospital, including dosing patients with nuclear medicine anywhere but the hospital (such as in their homes, at nuclear pharmacies, or anywhere the authorized user deemed appropriate). The commenter referenced the NRCs Regulatory Guide 8.39 1 patient release guidelines as onerous and stated that it is very rarely necessary to hospitalize an I-131 [iodine-131] patient. The commenter also stated that doctors are busy and no [exemption] paperwork should be required; the NRC should simply grant [blanket] regulatory relief.
Another commenter suggested that one exemption they may request is from the requirement for quarterly radiation safety committee (RSC) meetings. NRC staff followed up on this comment by noting that the NRC does not have a regulatory requirement for quarterly RSC meetings, however, this could be a license condition or in a procedure tied down to the license, and these licensees would need to request an exemption. The commenter said that in the past, NRC and Agreement State inspectors have asked to see RSC meeting reports and suggested that the NRC ensure that inspectors are aware of exemptions and that there may be future irregularities related to the COVID-19 response. NRC staff said that all exemptions would be placed on licensees dockets and that inspectors would be aware of them.
One commenter noted that patient volumes would be greatly reduced and asked whether there would be an annual fee exemption? NRC staff answered that the NRC regional offices were aware of this issue and discussions regarding fees were ongoing. NRC staff also noted that the Commission had recently approved a 90-day suspension of NRC fee billing. Additional information on NRC invoice deferral due to the COVID-19 pandemic can be found at https://www.nrc.gov/about-nrc/regulatory/licensing/covid-19-fees-faq.pdf.
A couple of commenters asked whether exemptions would be granted for specific authorized user training and experience (T&E) requirements, however the NRC staff responded that they could not provide an answer regarding specific exemptions during the meeting.
Commenters suggested additional areas where medical licensees may need temporary exemptions, including sealed source inventory and leak tests, annual refresher training, meter calibrations, survey frequencies, annual program reviews and reports, and 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material, requirements such as 10-year reinvestigations and annual training. Another commenter questioned whether a sealed source could be considered as in storage if the facility was 1 Regulatory Guide 8.39, Revision 1, Release of Patients Administered Radioactive Material, is available at ADAMS Accession No. ML19232A081.
April 22, 2020 Meeting Summary ML20122A253 closed, and NRC staff answered that this was something that was being looked into for 10 CFR 35.67, Requirements for possession of sealed sources and brachytherapy sources.
Another commenter noted that some radiopharmacies were no longer bringing deliveries of radiopharmaceuticals into buildings, and instead were handing over deliveries in facility parking lots. NRC regional staff said they were aware of this issue and were addressing it with specific licensees.
Two commenters reported that in some cases, radiation safety officers were being furloughed and were unable to access their facilities. NRC staff said that if anyone believes a licensee is in an unsafe situation or not complying with regulations without approved regulatory relief, including ensuring licensees have an appropriate radiation safety officer available, the NRC regional office should be informed of this situation immediately.
One commenter asked about the situation when a licensee is unable to complete corrective actions required by a confirmatory order due to the COVID-19 PHE. The commenter asked who should be contacted to inquire about possible exemptions related to confirmatory order requirements. NRC staff noted that confirmatory actions are a matter of enforcement, and that confirmatory orders should include a clause that specifies who to contact in the case that an order cannot be completed.
A commenter noted that many regulatory commitments that are time-sensitive fall under 10 CFR Part 19, Notices, Instructions and Reports to Workers: Inspection and Investigations, and Part 20, Standards for Protection Against Radiation, and asked why only Part 35 exemptions were being discussed. NRC staff answered that although this meeting was specifically focused on Part 35 exemptions, the NRC was receiving and reviewing exemptions from other regulations and is currently evaluating those.
Inspections Several commenters asked questions about on-site inspections. One commenter questioned whether any future decision by the NRC to resume on-site inspection would consider decrees by Governors? For example, would the NRC resume inspections if a Governor is prohibiting face-to-face inspections? NRC staff noted that a recent Department of Justice memo stated that rulings by Governors are not binding on Federal employees, however, the NRC understands that licensees are extremely busy, and the NRC does not wish to endanger NRC inspectors and licensees unless there is a significant safety concern that requires NRC in-person follow-up. Staff stated that the NRC management is engaged in ongoing discussions regarding what criteria would be needed to allow inspectors back into the field. NRC staff noted that resumption of inspections would likely be State or even county-dependent, and that any resumption of inspection activities would be measured. A few commenters asked whether the NRC was considering remote inspections in place of on-site inspections, and whether an announcement would be made by the NRC on any decisions related to Inspection Manual Chapter 2800, Materials Inspection Program. NRC staff answered that yes, the NRC is considering the possibility of conducting inspections remotely, and that some power reactor inspections are being conducted remotely. The NRC is also aware that some Agreement States are conducting some inspections remotely, as well. The staff said that any future changes to inspections would be clearly communicated to licensees.
April 22, 2020 Meeting Summary ML20122A253 Blanket Exemptions Throughout the meeting multiple commenters urged the NRC to issue blanket exemptions for medical licensees. These commenters stated that submitting exemption requests would be too burdensome for healthcare professionals responding to the PHE. Some commenters suggested that the NRC should issue blanket or class action exemptions for the regulations listed in the table referenced by NRC staff during their presentation (ADAMS Accession No. ML20129K060), and not doing so would be a great disservice to the medical community. NRC staff answered that due to the agency processes, the NRC is unable to grant blanket relief at this time, and this is why the staff is working to expedite exemption requests. However, staff noted that the NRC is evaluating issuance of an enforcement guidance memorandum (EGM).
An EGM would permit NRC inspection staff temporary enforcement discretion for certain violations. A decision has not yet been made with regard to an EGM for materials licensees, and the NRC is monitoring the types and number of medical exemptions that are being requested to determine whether an EGM would be needed.
NRC and Agreement State Coordination A couple questions were asked regarding NRC and Agreement State coordination, and whether the NRC was encouraging the Agreement States to follow the NRCs approach to granting temporary regulatory relief. One commenter from an Agreement State noted that their Agreement State had already provided blanket relief for a number of requirements without the need to request exemptions, and asked why the NRC had not done the same. NRC staff answered that the NRC and the Agreement States were communicating and coordinating their COVID-19 responses, however, the NRC and Agreement States were all handling regulatory relief individually and through their own regulatory processes and procedures. The Chair of the Organization of Agreement States (OAS), Terry Derstine, reiterated this answer and noted that the NRC did not expect the Agreement States to adopt the NRCs approach, and that the OAS had developed a Web site compiling links to Agreement States COVID-19 responses. That Web site is available at https://www.agreementstates.org/covid-19-response.html.
Other General Questions A commenter asked whether the NRC master materials licensees (MMLs) needed to follow the NRCs exemption process. NRC staff answered that yes, MMLs are expected to follow the same exemption process as appropriate and that this has been discussed with the MMLs.
A question was asked about exemptions for linear accelerators, and the NRC staff noted that the NRC does not regulate radiation-producing machines like linear accelerators. The OAS Chair, Terry Derstine, answered that questions about linear accelerators should be sent to the State radiation regulatory body.
Next Steps: The NRC staff is reviewing the feedback provided by medical licensees during the meeting and determining if any of the suggested areas of regulatory relief can be added to the table of potential 10 CFR Part 35 exemptions or other mechanisms for regulatory relief. The NRC will communicate future updates to the table and any other COVID-19-related regulatory announcements via Medical List Server e-mail. To subscribe to the Medical List Server, send April 22, 2020 Meeting Summary ML20122A253 an email to Medical-GC.Resource@nrc.gov with the word subscribe in the subject line. If licensees have questions regarding exemptions or the request process they should contact their NRC regional office contact, or e-mail questions or comments to MedicalQuestions.Resource@nrc.gov.
ENCLOSURES:
- 1. Medical Use Licensee Temporary Exemptions During the COVID-19 Public Health Emergency
- 2. NRC Meeting Participants
Package ML20122A254; Meeting Summary ML20122A253; NRC Slide Presentation ML20111A042; Meeting Notice ML20113E808; List of Exemptions ML20129K060
- via email OFFICE NMSS/MSST/MSEB/PM NMSS/MSST/MSEB NMSS/MSST/MSEB/BC NAME SLopas KTapp* CEinberg*
DATE 04/27/2020 04/27/2020 04/28/2020 OFFICE OGC NMSS/MSST/MSEB/BC NMSS/MSST/MSEB/PM NAME EHouseman* DEWhite* SLopas DATE 05/13/2020 05/14/2020 05/14/2020 Medical Use Licensee Temporary Exemptions During the Emergency Caused by the COVID-19 Public Health Emergency Updated: May 8, 2020 This table provides a list of 10 CFR Part 19, 20, 30, and 35 requirements for the which the NRC may consider expedited requests for temporary exemption. Licensees may seek a temporary exemption from these requirements to address the challenges licensees may face during the COVID-19 Public Health Emergency (PHE). This table may be updated as the NRC identifies additional requirements for which the NRC may consider expedited requests for temporary exemption.
Regulation Description of Regulation 35.60(b) The requirement in 10 CFR 35.60(b) that the licensee calibrate the instrumentation required in 10 CFR 35.60(a) in accordance with nationally recognized standards or the manufacturers instructions. (Note: this exemption should only be applied to instrumentation for which nationally recognized standards or manufacturers instructions require calibration at time intervals of a month or longer. Exemptions from § 35.60(b) should not be issued for other instrumentation without further review. In addition, this exemption should not be combined with extensions in calibrations intervals recommended by nationally recognized standards due to COVID-19 emergency.)
35.61(a) The requirement in 10 CFR 35.61(a) that the licensee calibrate survey instruments used to show compliance with 10 CFR Parts 20 and 35 annually.
35.67(b)(2) The requirement in 10 CFR 35.67(b)(2) that the licensee test sealed sources and brachytherapy sources for leakage at intervals not to exceed 6 months at other intervals approved by the Commission or an Agreement State in the Sealed Source and Device Registry.
35.67 (g) The requirement in 10 CFR 35.67(g) that the licensee in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such sources in its possession.
35.310(a) The portion of 10 CFR 35.310(a) that requires licensees to provide radiation safety instruction at least annually to personnel caring for patients or human research subjects who cannot be released under 10 CFR 35.75.
35.410(a) The portion of 10 CFR 35.410(a) that requires licensees to provide radiation safety instruction at least annually to personnel caring for patients or human research subjects who cannot be released under 10 CFR 35.75.
35.610(d)(2) The portion of 10 CFR 35.610(d)(2) that requires licensees to provide operational and safety instructions at least annually to individuals who operate the unit at the facility.
35.630(a) The requirement in 10 CFR 35.630(a) that the licensee perform calibration on the dosimetry system in accordance with the conditions in paragraph (a)(1) or paragraph (a)(2).
35.633(a)(3) The requirement in 10 CFR 35.633(a)(3) that the licensee perform calibration at intervals not exceeding 1 quarter for high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units with sources whose half-life exceeds 75 days.
1 Enclosure 1
Medical Use Licensee Temporary Exemptions During the Emergency Caused by the COVID-19 Public Health Emergency Updated: May 8, 2020 Regulation Description of Regulation 35.633(a)(4) The requirement in 10 CFR 35.633(a)(4) that the licensee perform full calibration at intervals not exceeding 1 year for low dose-rate remote afterloader units.
35.635(a)(3) The requirement in 10 CFR 35.635(a)(3) that the licensee perform full calibration at intervals not exceeding 1 year for gamma stereotactic radiosurgery units.
35.655(a) The requirement in 10 CFR 35.655(a) that the licensee shall have each teletherapy unit or gamma stereotactic unit fully inspected and serviced at intervals not to exceed 5 years for each teletherapy unit/7 years for each gamma stereotactic radiosurgery unit.
35.3045(d) The requirement in 10 CFR 35.3045(d) that the licensee submit a written report to the appropriate regional office within 15 days after discovery of a medical event.
20.1101(c) The requirement in 10 CFR 20.1101(c) that the licensee shall periodically (at least annually) review the radiation protection program content and implementation.
19.13(b) The requirement in 10 CFR 19.13(b) that each licensee shall provide an annual report to each individual monitored under 10 CFR 20.1502 of the dose received in that monitoring year if (1) The individuals occupational dose exceeds 1 mSv (100 mrem) TEDE or 1 mSv (100 mrem) to any individual organ or tissue; or (2) The individual requests his or her annual dose report.
30.34 The requirement in License Condition [number] to comply with the commitment in the letter dated XXXX to (Annual Radiation provide annual radiation safety refresher training as described in NUREG-1556, Volume 9.
Safety Training License Condition) 2
U.S. NUCLEAR REGULATORY COMMISSION MEETING TO DISCUSS TEMPORARY REGULATORY RELIEF FOR MEDICAL LICENSEES DURING THE COVID-19 PUBLIC HEALTH EMERGENCY April 22, 2020 NRC Meeting Participants Name NRC Affiliation Daniel Dimarco NRC, Office of Nuclear Material Safety and Safeguards, Division of Materials Safety, Security, State, and Tribal Programs, Medical Safety and Events Assessment Branch (NRC/NMSS/MSST/MSEB)
Lisa Dimmick NRC/NMSS/MSST/MSEB Chris Einberg NRC/NMSS/MSST/MSEB Jennifer Fisher NRC/NMSS/MSST/MSEB Sara Forster NRC, Region III, Division of Nuclear Materials Safety, Materials Licensing Branch Esther Houseman NRC, Office of the General Counsel Donna-Beth Howe NRC/NMSS/MSST/MSEB Kellee Jamerson NRC/NMSS/MSST/MSEB Donna Janda Chief, Medical and Licensing Assistance Branch, NRC, Region I, Division of Nuclear Materials Safety (NRC/RI/DNMS/MLAB)
Penny Lanzisera NRC/RI/DNMS/MLAB Mike Layton Director, NRC/NMSS/MSST Sarah Lopas NRC/NMSS/MSST/MSEB George Smith Chief, Source Security and Management Branch, NRC/NMSS/MSST Katie Tapp NRC/NMSS/MSST/MSEB Duncan White NRC/NMSS/MSST, State Agreements and Liaison Programs Branch Enclosure 2