ML20135G763
| ML20135G763 | |
| Person / Time | |
|---|---|
| Issue date: | 05/13/2020 |
| From: | Sarah Lopas NRC/NMSS/DMSST/MSEB, Division of Nuclear Materials Safety I |
| To: | |
| Sarah Lopas, 415-6360 | |
| References | |
| Download: ML20135G763 (13) | |
Text
SNMMI Town Hall:
Temporary Exemptions for Medical Licensees During the COVID-19 Public Health Emergency Division of Materials Safety, Security, State, and Tribal Programs, NRC Office of Nuclear Material Safety and Safeguards Division of Nuclear Materials Safety, NRC Region I
May 5 Letter to Medical Licensees
- Letter contains information for medical licensees requesting certain temporary exemptions.
- Enclosure to the May 5 letter contains a table of Parts 19, 20, 30, and 35 requirements for which the NRC may consider expedited requests for temporary exemption.
- Letter and Enclosure can be accessed at ADAMS Package No. ML20126G385 and on the NRCs Medical Uses Licensee Tool Kit:
https://www.nrc.gov/materials/miau/med-use-toolkit.html 2
Temporary Exemptions
- Exemptions are expected to be temporary.
- The expiration date of the exemption and/or any extension of deadlines to comply with regulatory requirements will be specified.
- Should additional time beyond the exemption be needed, the NRC would consider an exemption based on a subsequent request that updates all the information in the initial request.
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NRC Preparation for Anticipated Relief Requests
- Developed guidelines and a template to assist NRC regions in quickly processing anticipated exemption requests.
- Continually reviewing information received from medical professional societies and medical licensees regarding the impact of the COVID-19 emergency.
- April 22 meeting to gather stakeholder input (meeting summary available at ML20122A253)
- ACMUI COVID-19 subcommittee report and April 30 meeting (subcommittee report available at ML20125A148)
- Unanticipated requests will be evaluated but may take more time to process.
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Regional Divisions of Nuclear Material Safety Points of Contact for Regulatory Relief
- Region I James Trapp, Director James.Trapp@nrc.gov
- Region III David Pelton, Director David.Pelton@nrc.gov
- Region IV Mary Muessle, Director Mary.Muessle@nrc.gov
- Online request submission form:
https://www.nrc.gov/about-nrc/covid-19/materials/materials-relief-req-form.html 5
Agreement State Licensees
- Agreement States have developed their own regulatory responses to the COVID-19 emergency.
- See the Organization of Agreement States (OAS) Web site for links to Agreement State COVID-19 responses:
https://www.agreementstates.org/covid response.html 6
What to Include in COVID-19 Exemption Requests
- Request to seek regulatory relief that may be necessary during the COVID-19 emergency.
- Description of activities and parts of the facility that are shut down or where staff access is limited.
- Description of activities and parts of the facility that are operational.
- Description of any other COVID-19 related circumstances that affect the licensees ability to comply with certain regulatory requirements.
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What to Include in COVID-19 Exemption Requests (continued)
- Regulations, license conditions, or license commitments for which licensee is seeking temporary relief.
- Compensatory measures to ensure that licensed material is being stored and used safety.
- Length of time shut down or restriction to facility is expected, and actions to be taken when re-start occurs.
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Emergency Relief Requests
- If necessary, licensees may request immediate exemptions via e-mail or phone
- Phone requests must be followed-up within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> with a written request
- Directors of the regional Divisions of Nuclear Materials Safety can provide oral authorization of the requested exemption if immediate relief is needed and they deem appropriate.
- In urgent, off-hours cases, call the Headquarters Emergency Operations Center at (301) 816-5100 9
Types of Requests Received in NRC Region I
- Licensee-mandated no or limited access to facilities (e.g., only Essential Employees allowed access to portions of facility)
- Affects daily, weekly, monthly, quarterly, semi-annual, and annual commitments for Radiation Safety Program:
- Area surveys
- Package receipt timelines
- Equipment/dosimetry calibration and testing
- Dosimetry exchange
- Routine inventories (sealed & unsealed)/sealed source leak tests
- Routine audits
- Routine training
- Vendor activities (e.g., source exchange, preventative maintenance) 10
Enclosure to May 5 Letter ML20126G387 11
Enclosure to May 5 Letter ML20126G387 (continued)
- A link to the most up-to-date table will always be available on the NRCs Medical Uses Licensee Tool Kit Web site:
https://www.nrc.gov/materials/miau/med-use-toolkit.html 12
For Additional Information
- For questions, contact your NRC Regional Office Contacts or send an e-mail to MedicalQuestions.Resource@nrc.gov
- NRCs COVID-19 Web site for Medical, Industrial, and Academic licensees:
https://www.nrc.gov/about-nrc/covid-19/materials/med-indust-academic.html
- Subscribe to the NRCs Medical List Server by sending an e-mail to Medical-GC.Resource@nrc.gov with the word subscribe in the subject line.
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