ML20287A522
| ML20287A522 | |
| Person / Time | |
|---|---|
| Issue date: | 10/21/2020 |
| From: | Rachel Johnson NRC/NMSS/DMSST |
| To: | |
| Johnson R | |
| Shared Package | |
| ML20287A506 | List: |
| References | |
| Download: ML20287A522 (6) | |
Text
Resolution of OAS Comments on TI-003, Evaluating the Impacts of the COVID-19 Public Health Emergency as Part of the Integrated Materials Performance Evaluation Program (IMPEP)
RCPD-20-008 Letter Dated - August 24, 2020 Comment No.
Location Comment Accepted Remarks 1
Section I.A.
(pg. 1)
Section I.A. (pg. 1) states "Due to the ever-changing nature of the COVID-19 PHE, the Office of Nuclear Material Safety and Safeguards (NMSS) will re-evaluate and as necessary, revise this Temporary Instruction (TI) every 24 months until such time as the COVID-19 PHE impacts on the National Materials Program are no longer seen during IMPEP reviews."
Given that the COVID-19 PHE is ever-changing, does NMSS plan to re-evaluate/revise the TI more frequently than 24 months if warranted? If more frequent evaluation/revision is possible, consider adding the phrase at least every before 24 months.
Yes.
Section I.A will be revised to include as necessary, but at least once every before 24 months.
2 Section I.B. (pg. 1)
Section I.B. (pg. 1) states In order to maintain consistency and bound the effects of the COVID-19 PHE, each Program will need to establish the dates in which impacts from the COVID-19 PHE applied within their jurisdiction.
The COVID-19 PHE will have both direct and indirect effects on programs; some indirect matters could last months or years beyond the perceived end date for the impacted period. The Board urges future Integrated Materials Performance Evaluation Program No.
No change is necessary.
The intent of the TI is to address items directly impacted by COVID-19 PHE and their delayed completion and resolution.
As an example, the TI allows for those inspections and licensing actions going overdue during the COVID-19 phase (direct effect) to be
Comment No.
Location Comment Accepted Remarks (IMPEP) teams to consider this fact while reviewing a program. The Board recommends that a statement be added to recognize this fact. Even if a state indicates one set of dates for an impacted period, the team should provide leniency and flexibility discussed by this TI in evaluating indirectly affected program areas beyond the bounded time period.
Example: A program may indicate the end of their impacted period to be when they resume normal inspection activities, and this would mark the end of the direct effect of the PHE. The indirect effect would be all the delayed or overdue inspections. The end of that indirect period would coincide with when the program is no longer backlogged on inspection activities. As long as the program has a plan and is carrying it out, then the IMPEP team should not penalize a program during this prolonged period of time.
completed during the normal phase without penalty under IMPEP.
IMPEP Teams will not consider adverse impacts to an indicator if the direct impact related to COVID-19 PHE is completed after the Program exits the defined COVID-19 phase.
However, it should be noted that items with due dates after the defined COVID Phase, such as inspections, should be completed on time and if these inspections go overdue, they should be considered in the overall rating of the indicator.
As an alternative to the indirect effect mentioned in the example, a Program may decide to use the risk informed approach in IMC 2800 as a way to leverage the inspection load post-COVID phase, by re-evaluating the licensees coming due for inspection to determine whether flexibilities in accordance with IMC2800 Section 06.03, Extension of Inspection Interval, can be applied.
Comment No.
Location Comment Accepted Remarks 3
Throughout Throughout the document the word "prompt" is used.
Since it is not defined, it is important to acknowledge that "prompt" may mean something significantly different during the COVID-19 PHE situation than in a normal situation.
No.
The 12 instances of the term prompt and promptly, all occur under performance indicator objectives that should not be adversely affected by the impacts of the COVID-19 PHE sections; and are required to be completed without delay, or immediately.
4
- a.
Section V.D.2.f.
(pg. 5)
Under each section of Indicator Specific Guidance, performance indicator objectives that "should not be adversely affected" are identified. Two of the should not be adversely affected indicator objectives seem to have potential to be affected by obstacles caused by the COVID-19 PHE:
- a.Section V.D.2.f. (pg. 5) "Inspection findings lead to appropriate and prompt regulatory action". It should be made clear that regulatory relief is being provided for some items, and this may affect prompt regulatory action.
No.
For the example referenced for Section V.D.2.f, while regulatory relief may be provided for some items, it should not impact the ability of the Program to take appropriate and prompt regulatory action. If relief was given for a certain aspect of a licensees program the Program would not take a regulatory action because the finding was for a manner given regulatory relief.
Comment No.
Location Comment Accepted Remarks
- b.
Section V.F.2.e.
(pg. 7)
- b.Section V.F.2.e. (pg. 7) "Allegations are investigated in a prompt, appropriate manner."
While this is the expectation and goal, it should also be made clear that if an investigation requires on-site activity, the promptness of this may be affected. Some hospitals or COVID-19 hotspots may not be accessible to inspectors in the same manner as in a non COVID-19 situation.
The example referenced for Section V.F.2.e, does not negate the need for prompt and appropriate investigations of Allegations received by the Program.Section V.F.1.a (e.g., Alternative approaches in event or allegation response) allows for flexibility in the manner a Program responds to an Allegation, however given that Allegations are potential acts of impropriety it is imperative that a Program evaluate and prioritize the need for response and response as appropriate based on the potential to impact public health and safety, security, and the environment.
5 Section V.C.2.a.
(pg. 4)
Section V.C.2.a. (pg. 4) states "Inspection findings are communicated to licensees in a timely manner." This could be affected if there are delays in sending results, i.e. office closures while having to send certified mail, or individuals with signature authority unavailable for extended times.
No.
If an inspection is performed, the COVID-19 PHE should not be the reason inspection findings are not communicated in a timely manner. It is imperative that if violations are found during the inspection that timely communication to the licensee occurs so that corrective actions can be implemented by the licensee in order to ensure the safe use of radioactive material. There are other
Comment No.
Location Comment Accepted Remarks ways to communicate inspection findings (especially for clear inspections) in order for them to be found timely. As an example, a Program could email the findings using a secure method rather than using certified mail. They could also hold a virtual exit meeting with Program management, the inspector, and key licensee management in order to communicate deficiency findings.
6 Section V.E.1.a.
(pg. 6)
Section V.E.1.a. (pg. 6) states "Timeliness of renewal actions. Licensees, and in particular medical licensees may take longer to respond to deficiency letters due to having to respond to the COVID-19 PHE." A similar comment should be included in Technical Quality of Inspections for programs allowing additional time for licensees to respond to inspection deficiencies/violations.
No.
The Technical Quality of Inspection performance indicator objectives are focused on Program performance.
IMPEP evaluates the timeliness of inspection findings issued to the licensee. This time frame is defined by the amount of time between the date of the inspection exit until issuance of inspection findings and should be completed within 30 days.
It does not include time that occurs after an inspection while the inspector is waiting for additional information from the licensee to complete the inspection. A formal
Comment No.
Location Comment Accepted Remarks exit with the licensee would occur after that additional information is received. Unlike licensing actions like renewals, which cannot be completed until a response is received from the licensee, in inspection space the inspection is complete when the findings are issued and a licensees response to those findings does not impact that date.
ADAMS ACCESSION NUMBERS PACKAGE: ML20287A506 COMMENT RESOLUTION DOCUMENT: ML20287A522