ML20136A085
| ML20136A085 | |
| Person / Time | |
|---|---|
| Issue date: | 05/19/2020 |
| From: | George Wilson NRC/OE |
| To: | |
| Jones D | |
| References | |
| EGM-20-002 | |
| Download: ML20136A085 (11) | |
Text
SUBJECT:
ENFORCEMENT GUIDANCE MEMORANDUM 20-002 - DISPOSITIONING VIOLATIONS OF NRC REQUIREMENTS UNDER 10 CFR PARTS 30-36, AND 39, RESULTING FROM IMPACTS OF THE COVID-19 PUBLIC HEALTH EMERGENCY (PHE), WHERE THE LICENSEE SUSPENDED THE USE OF LICENSED MATERIAL AND PLACED MATERIAL IN SAFE STORAGE (ATTACHMENT 2)
Purpose:
The purpose of this attachment is to provide guidance to U.S. Nuclear Regulatory Commission (NRC) inspection staff for the disposition of violations of NRC requirements under Title 10 of the Code of Federal Regulations (CFR) Parts 30-36 and 39 that occurred because of the COVID-19 public health emergency (COVID-19 PHE).1 Specifically, discretion may be granted for certain noncompliances by a licensee that chooses to suspend use of licensed material2 and has placed and maintained all licensed radiological material in safe storage in accordance with applicable requirements during the COVID-19 PHE.
Background:
NRC licensees are expected to comply with all applicable NRC requirements; however, the NRC acknowledges the possibility that the COVID-19 PHE might impact a licensees ability to maintain compliance with all requirements. The NRC has received inquiries from materials licensees and industry groups regarding both potential and actual impacts of the COVID-19 PHE and their ability to remain in compliance with NRC regulations and license conditions.
The NRC anticipates that licensees will implement social distancing practices, which may result in their suspension of the use of licensed material for the purpose of conforming with:
the Presidents Coronavirus Guidelines for America; the Centers for Disease Control and Prevention Interim Guidance for Businesses and Employers; and the Occupational Safety and Health Administration 3990-03, Guidance on Preparing Workplaces for COVID-19; as well as additional applicable guidance, recommendations, or restrictions imposed at the Federal, State, and local levels.
Discussion:
Licensees may choose to suspend use of licensed material in response to State and local COVID-19 orders or federal guidelines. The impact of social distancing, stay-at-home orders, or illnesses due to COVID-19 could result in licensees not having sufficient staff to continue their use of licensed material. Some regulatory requirements can only be met when an individual is onsite and in an at-work status. Given these circumstances, licensees may be challenged to comply with certain regulatory requirements and/or license conditions. Examples of these 1
The provisions of this EGM are to be applied to noncompliances that occurred since the Secretary of the United States Department of Health and Human Services declared the COVID-19 PHE on January 31, 2020, and not more than 1 year from the issuance date of this EGM.
2 For the purpose of this EGM, suspend use of licensed material means the licensee has placed or maintained all existing radiological material in safe storage in accordance with applicable requirements; suspended use of licensed materials; no licensed material is accessed for use or disposal; and no additional material is obtained.
EGM-20-002 Attachment 2
2 requirements include: equipment testing, checks, or calibration; equipment maintenance or exchange; program reviews; retraining/recertification; dosimetry exchange; monitoring/sampling and surveys; and the submission of reports to the NRC. Table 1 lists specific regulations for which the NRC may choose to exercise enforcement discretion in accordance with this EGM.
The regulations are sorted by topic, and each grouping includes a basis for discretion as well as guidance for restoring compliance when a licensee resumes the use of licensed material.
Should a licensee suspend its use of licensed material and place licensed radiological material in safe storage in accordance with the regulations, the NRC will continue to have reasonable assurance of adequate protection of public health and safety and the common defense and security if certain other required activities are postponed for a specified brief period of time and are completed in a timely manner upon the resumption of use of licensed material. Accordingly, the NRC believes it is appropriate, under certain conditions, and for a specified brief period of time, to exercise enforcement discretion for certain violations by licensees that have suspended use of licensed material and placed the material in safe storage in accordance with NRC regulations. Once a licensee decides to resume the use of licensed material, it must also restore compliance in accordance with the timelines in Table 1.
If a licensee has more than one license, the licensee may suspend use of licensed material under one license and continue use of licensed material under another license; however, note that for the discretion described in this EGM to be granted, the material storage areas must not be co-located. For example, a hospital with two licenses may be granted discretion if licensed activities are suspended by the organization using materials under the first license (e.g., its research department), as long as the designated safe storage area for the materials under that license is not accessed by personnel conducting activities under the second license (e.g.,
diagnostic department).
A licensee may also submit an exemption request if relief is needed for a regulation that is not listed in Table 1, or if it needs relief from the timelines listed in Table 1 to restore compliance.
For a noncompliance that meets Conditions A - E of this EGM (below), a licensee does not need an exemption in order for the NRC to exercise discretion.
Actions:
Basis for Granting Enforcement Discretion:
In accordance with the NRC Enforcement Policy, Section 3.5, Violations Involving Special Circumstances, the NRC may exercise enforcement discretion and not cite licensees for violations of NRC requirements when application of the normal process is not appropriate given the circumstances. Given the special circumstances of the COVID-19 PHE and the impacts that licensees may encounter, in particular challenges to staffing levels due to illnesses or due to compliance with state and local social distancing orders, licensees may suspend use of licensed material and, as a result, be challenged to comply with all regulatory requirements or license conditions.
The NRC believes it is appropriate to exercise enforcement discretion for violations by affected licensees under certain conditions, and for a specified brief period of time, provided NRC continues to have reasonable assurance of adequate protection of public health and safety and the common defense and security. Table 1 provides a list of requirements, with corresponding bases, that may be considered for enforcement discretion.
EGM-20-002 Attachment 2
3 For a materials licensee that has suspended use of licensed material and placed all of its licensed radiological material in safe storage in accordance with applicable requirements (e.g., 10 CFR 20.1801, 30.34(i), 34.23, 34.35(c), and 39.31(b)), the NRC has reasonable assurance of adequate protection of public health and safety and the common defense and security if the licensee continues to comply with storage requirements and upon the resumption of use of licensed material restores compliance in a timely manner as stipulated in Table 1.
If an inspector identifies a noncompliance with specific requirements in 10 CFR Parts 30-36, and 39 (Table 1) and the licensee has maintained the material in safe storage and meets the conditions of this EGM, enforcement discretion may be granted. The inspector shall consult with the appropriate branch chief prior to granting discretion.
Note that this EGM does not provide guidance with respect to enforcement discretion for any violation associated with the requirements of 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material.
Conditions:
Enforcement discretion is reasonable if the licensee meets the following five conditions:
A. The licensees noncompliance occurred after the declaration of the COVID-19 PHE.
B. The identified noncompliance is listed in Table 1.
C. The licensee suspended use of licensed material during the COVID-19 PHE.
D. The licensee maintained radioactive materials in safe storage in accordance with applicable requirements (e.g., 10 CFR 20.1801, 30.34(i), 34.23, 34.35(c), and 39.31(b)).
E. The licensee restored compliance in accordance with Table 1 upon the resumption of use of licensed material (but in any event no later than 1 year from the issuance of this EGM).
Enforcement Discretion:
Enforcement discretion may be exercised for a noncompliance if conditions A - E described above are met. Violations associated with this enforcement discretion do not require discussion at an enforcement panel; however, they do require assignment of an enforcement action (EA) tracking number and shall be documented in an inspection report.
When exercising enforcement discretion in accordance with this EGM, the cover letter to the inspection report that discusses the violation should include the following or similar language:
A violation of [insert specific regulation or license condition] was identified.
Because the violation occurred as a result of the COVID-19 PHE described in Enforcement Guidance Memorandum 2020-002 (EGM-20-002) and because the licensee was implementing the conditions specified in EGM 2020-002, Attachment 2, the NRC is exercising enforcement discretion in accordance with Section 3.5, Violations Involving Special Circumstances, of the NRC Enforcement Policy and is not issuing an enforcement action for this violation.
EGM-20-002 Attachment 2
4 Long-Term Actions:
The NRC recognizes that impacts on a licensee could continue after the official termination of the PHE. Consequently, the provisions of this EGM may be applied after termination of the PHE to allow, on a case-by-case basis (not to exceed 1 year from the issuance date of the EGM), appropriate consideration of specific circumstances that arise during the inspection cycle following the PHE recovery.
NMSS Enforcement Point of
Contact:
Michele Burgess, Senior Regional Coordinator Office of Nuclear Material Safety and Safeguards Division of Division of Materials Safety, Security, State, and Tribal Programs Medical Safety and Events Branch E-Mail: michele.burgess@nrc.gov EGM-20-002 Attachment 2
5
SUBJECT:
ENFORCEMENT GUIDANCE MEMORANDUM 20-002 - DISPOSITIONING VIOLATIONS OF NRC REQUIREMENTS UNDER 10 CFR PARTS 30-36, AND 39, RESULTING FROM IMPACTS OF THE COVID-19 PUBLIC HEALTH EMERGENCY (PHE), WHERE THE LICENSEE SUSPENDED THE USE OF LICENSED MATERIAL AND PLACED MATERIAL IN SAFE STORAGE (ATTACHMENT 2) DATE: 5/19/2020 DISTRIBUTION:
F. Peduzzi, OE J. Peralta, OE D. Jones, OE L. Sreenivas, OE M. Layton, NMSS K. Williams, NMSS M. Burgess, NMSS RidsEDOMailCenter OE Distribution OE-Web (3 days after issuance)
EGM File Binder Regional Enforcement Coordinators, NMSS, NSIR, and NRR OE R/F Publicly Available ADAMS: EGM-02-002 Memo: ML20083K794 ADAMS: EGM-20-002 Attachment 2 Memo: ML20136A085
- Via Email OFFICE OE/EB OE/EB RI/RA RIII/RA NAME DJones JPeralta* DLew* JGeissner*
DATE 05/05/2020 05/05/2020 05/08/2020 05/08/2020 OFFICE RIV/RA NMSS/D OGC OE/D NAME SMorris* JLubinski* TStienfeld* GWilson DATE 05/11/2020 05/14/2020 05/13/2020 George A. Wilson Digitally signed by George A. Wilson Date: 2020.05.19 14:14:11 -04'00' OFFICIAL RECORD COPY EGM-20-002 Attachment 2
1 EGM 20-002, Attachment 2 Table 1 - Requirements that may be Considered for Enforcement Discretion Regulations Deadline for Item
- Description3 Basis for Discretion (If Restoring (Topic)
Applicable) Compliance 1 Reports to Reports to NRC due in Reports that are due to 30.34(c)4 Within 30 days NRC timeframes of 30 days or NRC on a timeframe of 30.50(c)(2) of resuming longer. greater than 30 days are 31.5(c)(5) use of reports of lower 31.5(c)(8) licensed significance items, or are 31.5(c)(14) material follow-up reports of 32.52 higher significance items 32.56(a) where an initial report has already been submitted to the NRC. Accordingly, if the licensee maintained internal reports or other sufficient information to complete these reports and submits these reports within 30 days of resuming the use of the licensed material, it would still maintain reasonable assurance of adequate protection of public health and safety and the common defense and security.
3 This column is applicable for noncompliances with a regulation, Order, or license condition.
4 The regulation in 30.34(c) applies when the requirement described in the "Description" column is contained in a license condition.
EGM-20-002 Attachment 2
2 Regulations Deadline for Item
- Description3 Basis for Discretion (If Restoring (Topic)
Applicable) Compliance 2 Leak Testing Routine leak testing of Because the licensee has 30.34(c) Prior to sealed sources and testing suspended use of 31.5(c)(2) resuming use for depleted uranium licensed material, that 34.27(c)(1) of licensed contamination. eliminates the movement 34.27(e) material of and exposure to 35.67(b)(2)
Note 1: This does not sources, decreasing both 36.59(a) include leak tests if the the potential for and 39.35(c) sources exhibit signs that safety consequences of the source might be leaking. potential leaks.
Postponing leak tests Note 2: The leak testing does not pose a safety requirement for a sealed concern, as long as any source and device (SSD) leak tests that were due ranges from 6 months to 3 during the discretion years. period are completed prior to use. Therefore, this exercise of discretion would maintain reasonable assurance of adequate protection of public health and safety and the common defense and security.
EGM-20-002 Attachment 2
3 Regulations Deadline for Item
- Description3 Basis for Discretion (If Restoring (Topic)
Applicable) Compliance 3 Equipment Routine equipment testing, Where a licensee has put 30.34(c) Prior to Testing/ checks, or calibration all licensed material in 34.25(b)(1) resuming use Calibration required monthly or less safe storage and is not 35.60(b) of licensed frequently (such survey accessing that material, 35.61(a) material instrument calibrations that the potential for 35.630(a) are unable to be performed contamination is 35.633(a)(3) due to vendor closures). eliminated. Because 35.633(a)(4) there is no potential for 35.635(a)(3)
Note: This does not include contamination, and 39.33(c)(1) testing, checks, or therefore no need to calibrations required daily, detect and measure per use, or after repairs. contamination, the licensee does not need to use equipment while its use of licensed material is suspended. Therefore, postponing testing and calibration of this equipment does not pose a safety concern, as long as any testing and calibration that was due during the discretion period is completed prior to resuming use of licensed material. With respect to the requirement to test and calibrate HDR and GSR units, postponing testing and calibration of these units does not pose a safety concern, as long as any testing and calibration that was due during the discretion period is completed prior to resuming use of the licensed material.
This exercise of discretion would maintain reasonable assurance of adequate protection of public health and safety and the common defense and security, because the licensee suspended use of licensed material and is not using these instruments.
EGM-20-002 Attachment 2
4 Regulations Deadline for Item
- Description3 Basis for Discretion (If Restoring (Topic)
Applicable) Compliance 4 Equipment Routine equipment The exercise of discretion 30.34(c) Within 30 days Maintenance/ maintenance or exchange, for the delay in 35.655(a) of resuming Exchange provided that the licensee completing equipment 39.43(b) use of has demonstrated no maintenance or exchange licensed equipment malfunctions. would maintain material Examples include conduct of reasonable assurance of annual equipment adequate protection of maintenance outside the public health and safety normal frequency. and the common defense and security, because the licensee suspended use of licensed materials and the instrument is not in use.
5 Physical Routine periodic physical The licensee has 30.34(c) Prior to Inventory inventories of material. suspended use of 34.29(a) resuming use licensed material and is 35.67(g) of licensed Note: Typical frequencies not using the sources or 39.37 material are quarterly, six months, or devices, which are in safe annual. storage in accordance with applicable requirements. Therefore, this exercise of discretion would maintain reasonable assurance of adequate protection of public health and safety and the common defense and security.
6 Periodic Routine periodic program The exercise of discretion 20.1101(c)) Within 30 days Program reviews. Routine periodic for not conducting routine 30.34(c) of resuming Reviews, performance audits, safety oversight activities would 34.43(e) use of Periodic User reviews, inspections and/or maintain reasonable 36.51(d) licensed Performance observations of users. assurance of adequate 36.51(e) material Audits/ protection of public health 36.51(g)
Observations, Note: With respect to Part and safety and the Annual Safety 39 licensees, this discretion common defense and Reviews, applies to annual safety security, because the Annual reviews and annual licensee suspended use Inspection inspections as described in of licensed material.
39.13(b)(3) and (d), which are required by license conditions.
EGM-20-002 Attachment 2
5 Regulations Deadline for Item
- Description3 Basis for Discretion (If Restoring (Topic)
Applicable) Compliance 7 Radiation Routine periodic RSC The exercise of discretion 30.34(c) Within 30 days Safety meetings. for not conducting routine of resuming Committee oversight activities would use of (RSC) Note1: This does not maintain reasonable licensed Meetings include RSC meetings in assurance of adequate material response to an event or protection of public health incident or from establishing and safety and the an RSC. common defense and security, because the Note 2: With respect to Part licensee suspended use 35 licensees, this discretion of licensed material.
applies to the frequency of meetings of the RSC that is described in 35.24(f), which may be required at a specified frequency by license condition.
8 Periodic Routine periodic The licensee has 30.34(c) Within 30 days Retraining/ retraining/recertification suspended use of 34.43(d) of resuming Recertification (such as weapons licensed material and 35.310(a) use of qualifications, physicals, must restore compliance 35.410(a) licensed DOT training, radiation within 30 days of 35.610(d)(2) material safety or security program resuming use of licensed training, routine accreditation material (i.e., provide the testing requirements). required retraining).
Therefore, this exercise Note 1: Examples of of discretion would impacts could be due to maintain reasonable travel restrictions, assurance of adequate unavailability of staff, social protection of public health distancing, or the and safety and the cancellation of vendor common defense and training courses. security.
Note 2: This does not include initial training or certifications.
9 Dosimetry Extension to the dosimetry The exercise of discretion 30.34(c) Prior to Exchange exchange frequency, for this dosimetry resuming use provided within manufacturer exchange time would of licensed allowed specifications. maintain reasonable material assurance of adequate protection of public health and safety and the common defense and security, because the licensee suspended use of licensed material and is not using material that requires the tracking of accumulated dose.
EGM-20-002 Attachment 2
6 Regulations Deadline for Item
- Description3 Basis for Discretion (If Restoring (Topic)
Applicable) Compliance 10 Routine Routine periodic The exercise of discretion 30.34(c) Prior to Periodic monitoring/sampling. for this periodic resuming use Monitoring/ monitoring/sampling of licensed Sampling Note 1: This does not would maintain material include final surveys/release reasonable assurance of of site. adequate protection of public health and safety Note 2: This does not and the common defense include continuous and security, because the monitoring systems or licensee suspended use sampling that is part of any of licensed material, has containment system. placed all licensed material in safe storage, and is not using material that would lead to accumulated dose.
11 Routine Routine confirmatory The exercise of discretion 30.34(c) Prior to Confirmatory surveys. for this survey time would resuming use Surveys maintain reasonable of licensed Note 1: This does not assurance of adequate material include the final survey protection of public health required within the period and safety and the prior to placing the material common defense and in storage. security, because the licensee suspended use Note 2: This does not of licensed material and include surveys tied to is not using licensed continuous monitoring material.
systems.
EGM-20-002 Attachment 2