Nuclear Materials COVID-19 Activities: Decommissioning | Storage & Transportation | Fuel Cycle Facilities | MIAU & Agreement States

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Current Regulatory Issues

Medical, Industrial, & Academic Uses of Nuclear Materials and Agreement States Relief Requests Received

Licensee	Received	Issued	Additional Documents Supporting Issuance
The American Society for Nondestructive Testing, Inc.* (ASNT)	March 30, 2020	March 31, 2020
University of Connecticut	April 08, 2020**	April 10, 2020**
U.S. Department of Health and Human Services, Food and Drug Administration (FDA)	April 07, 2020**	April 23, 2020
Department of Health & Human Services National Institutes of Health	April 08, 2020** Amended April 14, 2020	April 23, 2020**
Howard University	April 10, 2020 Amended April 17, 2020 and April 20, 2020	April 27, 2020
Boehringer Ingelheim	April 23, 2020	April 28, 2020
Department of the Army Army Research Laboratory	April 20, 2020 Amended April 21, 2020	April 29, 2020
Department of the Army Army Research Laboratory	April 20, 2020 Amended April 21, 2020	April 29, 2020
Cordero Mining, LLC	April 22, 2020	April 29, 2020
Department of the Army US Army Aviation and Missile Command	April 09, 2020**	April 30, 2020**
University of Connecticut	April 17, 2020**	May 01, 2020**
U.S. Department of Homeland Security National Urban Security Technology Laboratory	April 30, 2020**	May 07, 2020
U.S. Department of Agriculture	April 29, 2020**	May 07, 2020
U.S. Army Joint Munitions Command Safety and Risk Management Directorate	April 20, 2020**	May 08, 2020
Banco de Sangre de Servicios Mutuos, Inc.	May 04, 2020*** May 06, 2020	May 15, 2020
Beaumont Health System	May 4, 2020	June 2, 2020
Agilent Technologies	May 01, 2020 May 04, 2020	May 15, 2020
Cardinal Health	April 30, 2020 May 5, 2020	May 15, 2020
Agilent Technologies, Inc.	May 6, 2020	May 19, 2020
Department of Veterans Affairs - Veterans Health Administration National Health Physics Program	May 4, 2020	May 19, 2020
NASA Glenn Research Center	May 07, 2020**	May 20, 2020
Wayne State University	May 12, 2020** May 21, 2020**	May 19, 2020
Wayne State University	May 12, 2020** May 21, 2020**	May 19, 2020
University of Michigan	May 13, 2020**	June 1, 2020
U.S. Environmental Protection Agency National Exposure Research Laboratory	April 27, 2020***	June 1, 2020
Ascension St. John Macomb Oakland Hospitals	May 28, 2020**	June 30, 2020
Bronson Battle Creek Hospital	May 28, 2020**	June 30, 2020
Siemens Medical Solutions USA, Inc.	June 1, 2020***	June 26, 2020
Department of Veterans Affairs	June 5, 2020	June 21, 2020
Schlumberger Technology Corporation	July 31, 2020	August 4, 2020
Howard University	July 23, 2020** August 6, 2020 August 10, 2020	August 25, 2020
Agilent Technologies, Inc.	August 5, 2020** August 13, 2020	August 25, 2020
U.S. Department of Homeland Security National Urban Security Technology Laboratory	August 7, 2020**	August 25, 2020
NASA Glenn Research Center	August 11, 2020***	August 31, 2020
Wayne State University	August 12, 2020*** August 17, 2020***	August 26, 2020
Certification Board of Nuclear Cardiology	June 24, 2020	September 17, 2020
University of Michigan	October 5, 2020**	October 28, 2020
Avera McKennan/Nuclear Medicine	October 8, 2020*** October 14, 2020	October 26, 2020
Washington University in St. Louis	September 28, 2020	November 9, 2020
Washington University in St. Louis	October 16, 2020	November 30, 2020
Department of Veterans Affairs  Veterans Health Administration  National Health Physics Program	November 13, 2020**	December 15, 2020
Department of Veterans Affairs Veterans Health Administration National Health Physics Program	November 15, 2020**	December 14, 2020***
University of Connecticut	December 14, 2020	January 22, 2021
Lightbox Jewelry Inc.	January 11, 2021	February 8, 2021
ChristianaCare Health Systems, Inc.	April 16, 2021***	May 4, 2021	April 19, 2021
Department of Veterans Affairs - Veterans Health Administration National Health Physics Program	April 26, 2021	June 29, 2021
Department of Veterans Affairs - Veterans Health Administration National Health Physics Program	December 3, 2021	December 14, 2021
Consumers Energy	January 7, 2022	January 13, 2022

*ASNT is an organization authorized to certify radiographers
**non-publicly available, security-related
***non-publicly available

Related Communications

• June 1, 2021, "Issuance of Extension to December 31, 2021, of the Temporary Addendum to Revision 1 of the NorthStar Medical Radioisotopes, LLC – RadioGenix® Molybdenum-99/Technetium-99m Generator System Licensing Guidance for Medical Use Licensees, Medical Use Permittees, and Commercial Nuclear Pharmacies (STC-21-031)" – The purpose of this letter is to provide information on the extension of Temporary Addendum (ML21134A082) to Revision 1 of the licensing guidance (ML20009C049) until December 31, 2021. 

• September 29, 2020, "Issuance of Temporary Addendum to Revision 1 of the NorthStar Medical Radioisotopes, LLC - RadioGenix® Molybdenum-99/Technetium-99m Generator System Licensing Guidance for Medical Use Licensees, Medical Use Permittees, and Commercial Nuclear Pharmacies (STC-20-068)" – The purpose of this letter is to provide information on the Temporary Addendum (ML20268A919) to Revision 1 of the licensing guidance (ML20009C049) set to expire on June 30, 2021, in response to training issues during the COVID-19 pandemic.

• August 18, 2020, "Medical Use Licensee Temporary Exemptions During the Emergency Caused by the COVID-19 Pandemic" – This is an updated table that provides a list of 10 CFR Part 19, 20, 30, and 35 requirements for which the NRC may consider expedited requests for temporary exemption.

• June 8, 2020, "Inspection Guidance During Transition from COVID-19 Mandatory Telework for the Nuclear Materials and Waste Safety Programs (STC-20-044)" – The purpose of this letter is to inform the Agreement States of the U.S. Nuclear Regulatory Commission's (NRC) inspection guidance and decision-making considerations for the organizations within the NRC responsible for inspections as the COVID-19 public health emergency (PHE) restrictions begin to ease across the country.

• May 20, 2020, "U.S. Nuclear Regulatory Commission Planned Actions Related to Certain Requirements for Part 37 During the Coronavirus Disease 2019 Public Health Emergency" – The purpose of this letter is to provide information regarding licensee requests for temporary exemptions from certain Title 10 of the Code of Federal Regulations (10 CFR) Part 37 security requirements during the COVID-19 public health emergency, and the process that the NRC plans to use when reviewing such requests.

• May 15, 2020, "U.S. Nuclear Regulatory Commission Planned Actions Related to Certain Requirements for Parts 30 & 34 During the Coronavirus Disease 2019 Public Health Emergency" – The purpose of this letter is to provide information regarding requests for temporary exemptions from certain requirements in Parts 30 and 34 of Title 10 of the Code of Federal Regulations (10 CFR) during the COVID-19 PHE, and the process that the NRC plans to use when reviewing such requests.

• May 14, 2020, "Issuance of Summary of April 22, 2020 U.S. Nuclear Regulatory Commission Public Meeting on Temporary Regulatory Relief for Medical Licensees During the COVID-19 Public Health Emergency" – The purpose of this letter is to transmit the NRC staff's summary of the April 22, 2020 public meeting and provide an update on COVID-19-related activities that have occurred since the public meeting.

• May 14, 2020, "Notification of Mailing Address Change Regarding Submittal of Fingerprint Cards (STC-20-039)" – The purpose of this letter is to inform the Agreement States that the mailing address to submit Criminal History fingerprint cards for processing has changed.

• May 07, 2020, "Information about the U.S. Nuclear Regulatory Commission's Actions During the COVID-19 Public Health Emergency (STC-20-038)" – The purpose of this letter is to inform Indian Tribes about the U.S. Nuclear Regulatory Commission's (NRC) commitment to our mission and our Principles of Good Regulation—Independence, Openness, Efficiency, Clarity and Reliability during the COVID-19 public health emergency.

• May 05, 2020, "U.S. Nuclear Regulatory Commission Planned Actions Related to Certain Requirements for Title 10 of the Code of Federal Regulations Parts 19, 20, 30, and 35 During the Coronavirus Disease 2019 Public Health Emergency" – The purpose of this letter is to provide information on licensee requests for temporary exemptions from certain requirements in 10 CFR Parts 19, 20, 30, and 35, including the process for such requests and the requirements for which the NRC may consider expedited requests for temporary exemption.

• May 01, 2020, "Information and Seminar Regarding Temporary Exemptions from Certain U.S. Nuclear Regulatory Commission Materials Licensees Subject to 10 CFR Part 37 Regulations During the Covid-19 Public Health Emergency (STC-20-037)" – The purpose of this letter is to provide information about: 1) the U.S. Nuclear Regulatory Commission's (NRC) consideration of temporary exemptions for materials licensees subject to Title 10 Code of Federal Regulations (10 CFR) Part 37; and 2) a May 5, 2020, public meeting to discuss how NRC licensees can request expedited temporary regulatory relief during the COVID-19 public health emergency through submission of certain exemption requests.

• April 22, 2020, "Information and Seminar Regarding Temporary Exemptions From Certain U.S. Nuclear Regulatory Commission Materials Licensees Subject To 10 CFR Parts 30 And 34 Regulations During The Covid-19 Public Health Emergency (STC-20-033)" – The purpose of this letter is to provide information about: 1) the U.S. Nuclear Regulatory Commission’s (NRC) consideration of temporary exemptions for materials licensees subject to Title 10 Code of Federal Regulations (10 CFR) Parts 30 and 34; and 2) an April 23, 2020, seminar to discuss how NRC licensees can request temporary regulatory relief during the COVID-19 public health emergency through submission of certain exemption requests.

• April 17, 2020, "Seminar with Medical Licensees to Request Temporary Regulatory Relief During the Covid-19 Public Health Emergency (STC-20-032)" – The purpose of this letter is to inform States and Indian Tribes that the U.S. Nuclear Regulatory Commission (NRC) is holding a seminar on April 22, 2020, to discuss how NRC medical licensees can request temporary regulatory relief during the COVID-19 public health emergency through submission of certain exemption requests.

• April 14, 2020, "Information Regarding Temporary Exemption from Certain U.S. Nuclear Regulatory Commission Medical Use Regulations (STC-20-031)" – The purpose of this letter is to provide information about the U.S. Nuclear Regulatory Commission's (NRC) exemptions for medical use licensees.

• April 07, 2020, "Information Regarding U.S. Nuclear Regulatory Commission Activities Surrounding the Novel Coronavirus COVID-19 (STC-20-029)" – The purpose of this letter is to provide information to the Agreement and Non-Agreement States about the U.S. Nuclear Regulatory Commission's monitoring activities associated with the novel Coronavirus Disease 2019 (COVID-19) and responses to common questions received regarding potential effects to the National Materials Program.

• April 03, 2020,"Extension to the Comment Period for the State Agreement (SA) Procedures Implementing the Integrated Materials Performance Evaluation Program (IMPEP); and Update on Scheduled IMPEP Reviews (STC-20-028)" – The purpose of the letter is to notify the Agreement States that the NRC is extending the date for Agreement States to review and comment on multiple NMSS SA procedures implementing the Integrated Materials Performance Evaluation Program (IMPEP). In addition, the NRC is also evaluating the use of virtual communication technologies such as Skype or Webex and other means, to conduct IMPEP reviews and Management Review Board (MRB) meetings remotely during the period of restrictions imposed by the COVID-19 pandemic.

Frequently Asked Questions

Is the NRC cancelling its upcoming training classes for Agreement States?

The NRC Technical Training Center announced that it is rescheduling, or holding virtually, its training courses through July 2020. The NRC on-line training courses continue to be available. Any questions about NRC training courses for Agreement States should be sent to AStrainingandtravelResource@nrc.gov.

How is the NRC keeping apprised on the status of the National Materials Program?

The State Agreements and Liaison Programs Branch in the Division of Materials Safety, Security, State, and Tribal Programs maintains frequent communications with the Regional State Agreement Officers and Regional Government Liaison Officers to exchange valuable information regarding the implementation of the National Materials Program. The same branch also maintains communications with the Organization of Agreement States, States and Tribal governments, and the Conference of Radiation Control Program Directors. In addition, the National Materials Program Co-Champions (NRC and Agreement State representatives) have been meeting frequently to discuss matters related to COVID-19.

What interaction is NRC having with the American Society for Nondestructive Testing (ASNT) and its certification program? Are expiring radiographer certifications being extended? If so, is NRC approving such extensions?

The NRC received a regulation exemption request from the ASNT regarding extending radiography certification expiration dates. The NRC granted the exemption request for ASNT to extend certifications expiring between March 31, 2020, and September 30, 2020, for up to two extensions in increments of no more than 90 days. The ASNT will notify the individual radiographers of the extensions via email. In addition, the ASNT will update each record on its website. The NRC and Agreement State inspectors can confirm the validity of radiography certifications through the ASNT Certificate Holders Directory. The NRC's full response to the requested exemption can be found using ADAMS Accession Number ML20090C666.

How will future IMPEP reviews consider any impacts of the COVID-19 situation in the timely completion of routine and/or reciprocity inspections?

The NRC is in the process of developing a Temporary Instruction (TI) to address how performance indicators will be evaluated by IMPEP teams for actions taken by NMP radiation control programs during the COVID-19 PHE. The NRC recognizes the Agreement State Programs' priority is the protection of public health and safety, as well as the protection of their employees. We also understand the disruptions the COVID-19 situation may cause to the conduct of inspections, licensing, and other elements of their programs. The NRC encourages the States to document any changes to normal implementation of their Radiation Control Programs so future IMPEP review teams have the information they need to perform their assessments. IMPEP reviews are performance-based and as such, the NRC does not expect the evaluations to be affected solely by the delays these interim restrictions may cause.

Specifically, Agreement States should document the inspections that could not be performed during the COVID-19 PHE period with an appropriate justification (e.g., travel restriction, denied access, etc.) and develop a plan to conduct the overdue inspections upon the easing of limitations caused by the COVID-19 PHE. During the IMPEP review, the team will take into consideration the list of overdue routine and reciprocity inspections impacted by the COVID-19 restrictions and evaluate them in accordance with the TI. The team will evaluate the implementation of the plan to conduct the overdue inspections.

Further, the IMPEP process allows for this flexibility as stated in SA-101, Status of Materials Inspection Program, Section V.B.8:

 

In applying the criteria, flexibility may be used to make the determination of the rating for this indicator. The review team should consider the status of the Program and any mitigating factors that may have prohibited the Program from conducting inspections during the review period. The review team's assessment should include the examination of plans to perform any overdue inspections or reschedule any missed or deferred inspections. The Principal Reviewer should determine that a basis has been established by the Program for not performing any overdue inspections or rescheduling any missed or deferred inspections.

 

Past IMPEP reviews have successfully evaluated Programs that were challenged to conduct timely inspections and licensing due to unique circumstances, such as natural phenomena events. Annual IMPEP team leader counterpart meetings and team member trainings will continue to include discussions of considerations to be applied based on unique circumstances to provide knowledge, understanding of a performance-based review, and use of the TI.

Can Agreement States give regulatory relief for certain tasks performed at licensee facilities (e.g., instrument calibration, radiation safety committee meetings, linearity tests, annual calibration, area surveys, etc.)?

An Agreement State Program has the authority to grant exemptions to the regulatory requirements provided protection of public health and safety is maintained. Therefore, the Agreement State should exercise judgment, thoroughly evaluate any exemption requests or determination to grant regulatory relief, and document its decision with regards to what requirements it decides to provide relief or exercise enforcement discretion.

Do Agreement States have the authority to issue similar exemptions to their licensees? Can the Agreement States issue "blanket exemptions" instead of issuing exemptions on a case-by-case basis? Does the NRC have to approve these exemptions for compatibility with NRC requirements?

Agreement States have the authority to issue exemptions to their licensees, provided the exemptions are protective of health and safety. Exemptions issued by Agreement States do not need prior approval from the NRC. One of the 28 criteria (Criterion 11) used to evaluate new Agreement State applications (see Commission Policy Statement Criteria for Guidance of States and NRC in Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through Agreements (46 FR 7540, January 23, 1981; as amended by policy statements published at 46 FR 36969, July 16, 1981; and 48 FR 33376, July 21, 1983) requires the State to have the authority to impose additional requirements to protect health and safety, or to grant necessary exemptions which will not jeopardize health and safety. All of the current 39 Agreement States have been evaluated against this criterion.

The NRC's Agreement State Program Policy Statement (82 FR 48535, October 18, 2017) recognizes the need for Agreement States to have flexibility in program implementation and administration to accommodate individual State preferences, State legislative direction, and local needs and conditions.

Agreement State programs need to take action in response to the COVID-19 PHE in accordance with the specific conditions in their State, the orders issued by their Governor and public health officials, and State administrative processes. Consequently, Agreement States have flexibility to issue exemptions to their licensees and flexibility in the administrative procedures they use to issue exemptions. The regulatory relief that the State approves may be different than those exemptions issued by the NRC.

How will the IMPEP review team view an Agreement State's decision to delay or not respond to an event or allegation?

The Agreement State should evaluate each incident or allegation on case-by-case basis and document their decision on their course of action. An IMPEP review will consider the COVID-19 restrictions and the public health safety significance of the event or allegation. The NRC would expect the review team to verify that the Agreement State evaluated the incident and if appropriate, considered following up on the allegation remotely when on-site response is not the best course of action considering the circumstances.