Text

Comment (01) of James E. Slider on Behalf of the Nuclear Energy Institute on PR-Chap 1- Retrospective Review of Administrative Requirements
	ML20128J340
Person / Time
Site:	Nuclear Energy Institute
Issue date:	05/06/2020
From:	Slider J; Nuclear Energy Institute
To:	; Office of Nuclear Material Safety and Safeguards
	SECY/RAS
References
	85FR6103, NRC-2014-0214
	Download: ML20128J340 (47)
	v • d • e

PR- Chap 1 1 85FR6103 JAMES E. SLIDER Technical Advisor, Regulatory Affairs 1201 F Street, NW, Suite 1100 Washington, DC 20004 P: 202.739.8015 jes@nei.org nei.org Submitted via Regulations.gov May 6, 2020 Mr. Andrew G. Carrera Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

Subject:

Comments on the NRCs Retrospective Review of Administrative Requirements [85 FR 6103; Docket ID NRC-2017-0214]

Project Number: 689

Dear Mr. Carrera:

The Nuclear Energy Institute (NEI) 1, on behalf of its members, submits the following comments the U.S. Nuclear Regulatory Commissions (NRCs) Retrospective Review of Administrative Requirements (RROAR). We appreciate this opportunity to respond to the subject Federal Register Notice (FRN) soliciting public comments 2 on the application of the NRCs final evaluation criteria to the NRCs reporting and recordkeeping requirements. We are deeply grateful for the extension of the public comment period granted by the NRC in light of the challenges presented by the pandemic response. 3 Our review of the NRC requirements was extensive, examining more than 300 reporting or recordkeeping requirements found in Title 10, Code of Federal Regulations, Parts 1-140. We compared these requirements to the five RROAR evaluation criteria and tallied the results in a large spreadsheet. In the process, several themes emerged which we address with recommendations in the enclosures to this letter. The major themes are as follows:

1. Burden is More than What Can Be Quantified: The Federal Register Notice included questions seeking to elicit information on the burden of existing reporting and record-keeping requirements. In responding to these questions, we realized that the burden of administrative regulations often cannot be quantified or is small on a per regulation basis. Rather, the burden is the cumulative impact of the 1

The Nuclear Energy Institute (NEI) is responsible for establishing unified policy on behalf of its members relating to matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEIs members include entities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect and engineering firms, fuel cycle facilities, nuclear materials licensees, and other organizations involved in the nuclear energy industry.

2 85 FR 6103 3

Noticed in Federal Register, Volume 85, page 18477, dated April 2, 2020.

Mr. Andrew G. Carrera May 6, 2020 Page 2 hundreds of small burdens the individual regulations, one by one, impose on the licensee. The cumulative burden potentially distracts from the focus of licensee management and operators on the most safety significant aspects of their licensed operations. With this in mind, many of our recommendations suggest the NRC reconsider the value of regulations that might seem to be minimally burdensome individually. Pruning those that no longer add meaningful value to the NRCs mission helps to reduce clutter and administrative burden on the licensee.

2. Consider the Maturity of the Industry and NRC: Many of the regulations were established when the industry and the NRC were less mature. In some cases, it is obvious the regulation was intended to address a novel or emergent situation (e.g., regulations that specify submitting an initial report by a date that now is long past). In other cases, the regulation appears to be based on a presumption that the facilities or programs subject to the regulation would be developing new features to address new requirements. We recommend that the NRC review its regulations looking for opportunities to eliminate requirements for submitting initial reports by completion dates that are no longer relevant (e.g., Part 20.2207(h) requirement for a report of initial inventory of tracked sources due by January 31, 2009). In addition, we recommend that the NRC review its regulations for instances in which the maturity of the industry and its programs today obviates the need for the report or regulation or warrants a simplification or refocusing of the requirement (e.g., the Part 50.54(t)(2) requirement for a periodic review of emergency preparedness drills, exercises, capabilities, and procedures).

3. Consolidate Related Requirements That Appear in Multiple Places: There are instances in which multiple regulations address part or all of a given situation or address similar or related situations, sometimes in different ways. Overlap and inconsistency in these applicable regulations make it harder for the reader to determine what is required or how to meet the requirement in the most efficient manner possible. One example is the treatment of reporting personnel radiation exposures in Parts 19 and 20. We recommend that the NRC review these regulations and consider consolidating and streamlining Parts 19 and 20 to simplify the presentation of requirements for reporting dose to NRC and workers. There are other regulations in which similar reporting requirements appear in multiple places, which we believe could be consolidated for consistency and clarity.

4. Reconsider Need for Submitting Reports When Onsite Inspection Would Suffice: The regulations specify submitting numerous reports to the NRC. In some cases, we are unable to determine whether or how the NRC actually uses the reports we submit (RROAR Criterion 1). In other cases, submitting the reports does not actually seem to help the NRC do its job (e.g., we receive requests from inspectors for copies of reports previously submitted as required and available to NRC staff via ADAMS). 4 We recommend that the NRC review all requirements for submitting written reports and determine whether the agencys needs can be met through other means. For example, licensees corrective action process (CAP) and quality records systems have matured significantly since most of the reporting requirements were set in the regulations. The NRC has unfettered access to these systems, which should allow for NRC to reconsider whether a one-off or periodic report based on the contents of those systems is still essential. Eliminating the requirement for submittal of a written report 4

Contrary to NRC Inspection Manual Chapter 0620, Inspection Documents and Records, Section 04.01.a, Effective January 28, 2019 (ADAMS ML18254A020).

Mr. Andrew G. Carrera May 6, 2020 Page 3 when inspection can meet the NRCs needs equally well would reduce the administrative costs the licensee bears for preparing and filing written reports on the docket.

5. Unify Timing of Written Follow-up Reports: The regulations specify a variety of time limits for the submittal of written follow-up reports. In our review of the regulations, it appears that none of the written follow-up reports is more significant to NRC oversight than the Licensee Event Report (LER),

for which the NRC allows 60 days. We recommend that the NRC adopt a 60-day response time for the completion/submittal of all written follow-up reports. This uniform deadline would simplify licensees management of the production of these reports to a common timeline.

6. Eliminate Non-Emergency Prompt Notifications: In NEIs Petition for Rulemaking (PRM) 50-116 5, we proposed that NRC eliminate immediate notification requirements for non-emergency events currently required by 10 CFR Part 50.72. (This petition remains open with the NRC6 and remains an industry priority for relieving administrative burden.) The principles espoused in PRM-50-116 apply equally well to other regulations requiring licensees to notify the NRC promptly or immediately. We recommend that the NRC review all of those regulations to determine which could be satisfied by licensee communications with their resident inspectors. Where notifying the resident inspector is a viable alternative to the current requirement to contact the NRC Headquarters or regional office, we would urge the NRC to adopt this as a standard approach to immediate notifications as much as practical. As explained in PRM-50-116, resident inspectors are most familiar with their plant and its circumstances. This makes notifications and follow-up communications with the resident inspector much more efficient and effective than through a watch officer in NRC Headquarters.

Details are provided in the enclosures. If you have questions in this matter, please contact either Justin Wearne at jmw@nei.org or (202) 739-8087, or me at jes@nei.org or (202) 739-8015.

Sincerely, James E. Slider Attachments (2) c: Ms. Pamela Noto, NRC/NMSS 5

The petition was docketed on November 18, 2018 and published in the Federal Register on November 20, 2018 at 83 Fed. Reg. 58509.

6 Status from NRC website, https://www.nrc.gov/reading-rm/doc-collections/rulemaking-ruleforum/active/PetitionDetails.html?id=26, retrieved April 29, 2020.

Mr. Andrew G. Carrera May 6, 2020 Page 1 Enclosure 1 Detailed Comments on the Retrospective Review of Administrative Requirements In the tables below, NEI provides detailed comments and recommendations on NRC regulations subject to the agencys Retrospective Review of Administrative Requirements (RROAR). The tables paraphrase the titles of the NRCs five RROAR screening criteria and show the screening criteria which NEI judges to be most applicable to the regulations listed. The tables then summarize NEI responses to the five questions from NRCs Federal Register Notice.

Questions on these comments should be directed to either Justin Wearne, jmw@nei.org, or Jim Slider, jes@nei.org.

Table 1: Radiological Dose Reporting in Parts 19 and 20 Applicable NRC RROAR Screening Criteria 1 - SCREEN IN 2 - SCREEN IN 3 - SCREEN IN 4 - SCREEN IN 5 - SCREEN Not Used in Alternative Consider Burdensome OUT Past 3 Years Process Less Frequent Needed for External Users X X X X Questions in Federal Register NEI Response Notice

1. Which administrative Applicable Regulations 1 regulations should the NRC § 19.13(a) & (b) - Annual report on radiation exposure consider changing? Include of employees the 10 CFR part, section, and § 19.13(c) - Report on radiation exposure of former paragraph(s). employees

§ 19.13(d) - Copy of report to NRC on individual radiation exposure

§ 19.13(e) - Report of radiation exposure of terminating employees

§ 20.1906(d) - Immediate report on surface contamination or external radiation levels above limits

§ 20.2201(a)(1)(i) - Immediate report on discovery of theft, loss or missing licensed material

§ 20.2201(a)(1)(ii) day report following discovery of theft, loss or missing licensed material

§ 20.2201(b) day report following telephone report on lost, stolen or missing licensed material 1

NEI has paraphrased the reporting and record-keeping requirements for display purposes.

Mr. Andrew G. Carrera May 6, 2020 Page 2 Questions in Federal Register NEI Response Notice

§ 20.2201(d) day report after learning of additional information on lost, stolen or missing licensed material

§ 20.2202(a) - Immediate notification of event involving exposure or release of byproduct, source of special nuclear material

§ 20.2205 - Copy of report to NRC on individual exceeding dose limits

§ 20.2206(b) - Annual report on personnel exposure and monitoring

2. How should the NRC change Recommendations the regulations? Can the 1. Consolidate the reporting requirements above by regulation be made less moving Part 19 reporting of dose to NRC and workers burdensome, or should it be into Part 20.

eliminated entirely? If 2. Change the timing on all written follow-up reports possible, provide specific from 30 days to 60 days to align with the timing of language showing how the LER submittals.

regulatory text might be 3. Recognize that information captured in the licensees changed to reduce burden. Corrective Action Program (CAP) or QA records Describe how the evaluation program is available for NRC inspection and can criteria would apply to the satisfy NRCs need for information without requiring proposed change(s). formal submittal of a report.

4. Eliminate prompt reporting via the NRCs Event Notification System or Operations Center in favor of reporting promptly to NRC via the resident inspector, when applicable, as described in Petition for Rulemaking PRM-50-116.

3. What is the basis for the Basis proposed change? Provide a 1. Radiological reporting requirements in Parts 19 and rationale for why the 20 are similar or overlapping. Consolidating them into requirement might be one 10 CFR Part (we suggest Part 20) would ensure obsolete or overly alignment and consistency of requirements and could burdensome and any relevant improve efficiency. Having duplicative requirements supporting data. with slightly different text creates uncertainty and inefficiency, contrary to the principles of good regulation.

2. Typically, a stations CAP system is structured to complete necessary causal evaluations in time to support completing a Licensee Event Report (when needed) within 60 days. Similar timing should suffice

Mr. Andrew G. Carrera May 6, 2020 Page 3 Questions in Federal Register NEI Response Notice for follow-up written submittals required by Part 20 and many other regulations.

3. Resident inspectors have access to data maintained in plant records or in the CAP system, which allows for efficient and real time NRC access to this data.

4. Prompt event reporting through the NRC resident inspector, rather than to NRC Headquarters in Rockville, MD, allows for more efficient use of resources because the resident inspector is most familiar with the plant and its situation.

4. What burden is associated Burden with the administrative Consolidating reporting requirements of Parts 19 and 20 requirements? Provide a would give NRC opportunity to streamline, simplify and quantitative basis for the ensure consistency of requirements. This would make burden in terms of costs or more efficient the licensees application of the current labor hours, if available. Parts 19 and 20 to any given situation.

5. How would the suggested Burden Reduction change reduce burden? NEI believes it is in NRCs and the public interest to Would it result in a onetime streamline radiological reporting requirements to ensure reduction in burden, a consistent and efficient interpretation and application of reduction in burden for these regulations.

multiple years, or an ongoing reduction in burden? Provide supporting justification.

Mr. Andrew G. Carrera May 6, 2020 Page 4 Table 2: Historical Reports That Are No Longer Relevant Applicable NRC RROAR Screening Criteria 1 - SCREEN IN 2 - SCREEN IN 3 - SCREEN IN 4 - SCREEN IN 5 - SCREEN Not Used in Alternative Consider Burdensome OUT Past 3 Years Process Less Frequent Needed for External Users X X Questions in Federal Register NEI Responses Notice

1. Which administrative Applicable Regulations regulations should the NRC § 20.2207(h) - Report initial inventory of tracked consider changing? Include sources by January 31, 2009 the 10 CFR part, section, and § 50, Appendix E, Sec. IV.D.4 - Report alert and paragraph(s). notification system design by June 24, 2013

2. How should the NRC change Recommendation the regulations? Can the These regulations reference historical requirements from regulation be made less the regulations implementation phase. They are no burdensome, or should it be longer relevant and should be eliminated.

eliminated entirely? If possible, provide specific language showing how the regulatory text might be changed to reduce burden.

Describe how the evaluation criteria would apply to the proposed change(s).

3. What is the basis for the Basis proposed change? Provide a The period of initial implementation has passed.

rationale for why the References to outdated reporting requirements linked to requirement might be the initial implementation period add clutter to the text.

obsolete or overly The text should present only what remains relevant for burdensome and any relevant current readers and do so clearly and concisely.

supporting data.

4. What burden is associated Burden with the administrative The continued presence of historical reporting requirements? Provide a requirements that are no longer relevant complicates the quantitative basis for the reading and understanding of the regulations. This burden in terms of costs or presents the potential for increasing confusion and labor hours, if available. uncertainty when readers are trying to answer questions about current situations.

Mr. Andrew G. Carrera May 6, 2020 Page 5 Questions in Federal Register NEI Responses Notice

5. How would the suggested Burden Reduction change reduce burden? Eliminating these now defunct requirements would Would it result in a onetime simplify the text of the regulations and reduce the reduction in burden, a challenge that readers face in trying to identify the reduction in burden for essential and relevant contents of a given regulation.

multiple years, or an ongoing reduction in burden? Provide supporting justification.

Mr. Andrew G. Carrera May 6, 2020 Page 6 Table 3: Annual Reporting on Work Hours Applicable NRC RROAR Screening Criteria 1 - SCREEN IN 2 - SCREEN IN 3 - SCREEN IN 4 - SCREEN IN 5 - SCREEN Not Used in Alternative Consider Burdensome OUT Past 3 Years Process Less Frequent Needed for External Users X X X X Questions in Federal Register NEI Response Notice

1. Which administrative Applicable Regulations regulations should the NRC § 26.203(e)(1) - Annually report the use of waivers consider changing? Include under which work was performed the 10 CFR part, section, and § 26.203(e)(2) - Annually report corrective actions paragraph(s). resulting from analyses of fatigue data

§ 26.417(b)(2) - Annually submit fitness for duty (FFD) program performance reports

§ 26.717(e) - Annually submit FFD program performance data

§ 26.719(c)(1) - Within 30 days of discovering errors in drug and alcohol testing, submit a report on the incident and corrective actions taken or planned

2. How should the NRC change Recommendations the regulations? Can the The annual reports should be eliminated. The 30-day regulation be made less report should be made due in 60 days, like LERs.

burdensome, or should it be eliminated entirely? If possible, provide specific language showing how the regulatory text might be changed to reduce burden.

Describe how the evaluation criteria would apply to the proposed change(s).

3. What is the basis for the Basis proposed change? Provide a It is not apparent whether or how NRC uses these annual rationale for why the reports. If they are used, the agency should demonstrate requirement might be that these reports add substantial, unique value to the obsolete or overly NRCs mission of protecting the public health and safety.

burdensome and any relevant supporting data. The information required to be submitted to NRC in these reports is readily available onsite for NRC inspection. In addition, this information is routinely examined as part of NRC Inspection Procedure (IP) 71152 (Problem

Mr. Andrew G. Carrera May 6, 2020 Page 7 Questions in Federal Register NEI Response Notice Identification and Resolution) 2 and IP 71130.08 (Fitness-for-Duty Program) 3 inspections. Work hour compliance is given additional scrutiny through reactive inspections under IP 71153 4, if an event occurs, and supplemental inspections under IP 95001, IP 95002 and IP 95003 5, if a Greater-than-Green inspection finding or performance indicator arises. If a Part 26-related issue causes a reportable event, then the licensee will submit a Licensee Event Report (LER) and the LER would provide details that are more relevant and useful to NRC oversight when specific concerns arise.

If the NRC needs information in the Part 26 annual reports occasionally for research purposes, then resident inspectors can retrieve the data from the licensees CAP system or site records or the NRC can make a one-time request to licensees.

4. What burden is associated Burden with the administrative The burden of the current reporting requirements is requirements? Provide a estimated to be approximately 20 person-hours per year quantitative basis for the per plant.

burden in terms of costs or labor hours, if available.

5. How would the suggested Burden Reduction change reduce burden? If the stated reports were eliminated, the burden Would it result in a onetime reduction would be ongoing.

reduction in burden, a reduction in burden for multiple years, or an ongoing reduction in burden? Provide supporting justification.

2 See IP 71152, Problem Identification and Resolution, Section 03.05, Sample Selection Guidance, Paragraph n, Fatigue-related issues identified through fitness for duty effectiveness reviews or licensee assessments reports, see 10 CFR 26.717(9). (Issued February 26, 2015, ADAMS ML14316A042) 3 IP 71130.08, Fitness-for-Duty Program, Issued October 22, 2018 (ADAMS ML17263A609) 4 IP 71153, Follow-up of Events and Notices of Enforcement Discretion, Section 03.03, Personnel Performance Sample, Review personnel performance during planned nonroutine plant evolutions. Determine whether personnel performance contributed to un-planned events and transients. Specific Guidance: Reviewworking hour records to evaluate for fatigue (Issued November 13, 2019, ADAMS ML19197A110) 5 IP 95001, Supplemental Inspection Response to Action Matrix Column 2 Inputs, Issued August 24, 2016 (ADAMS ML15223B348); IP 95002, Supplemental Inspection for One Degraded Cornerstone or Any Three White Inputs in a Strategic Per-formance Area, (Issued February 9, 2011, ADAMS ML1002020532); IP 95003, Supplemental Inspection for Repetitive Degraded Cornerstones, Multiple Degraded Cornerstones, Multiple Yellow Inputs or One Red Input, (Issued December 18, 2015, ADAMS ML15188A400)

Mr. Andrew G. Carrera May 6, 2020 Page 8 Table 4: Prompt Notifications on Work Hours Applicable NRC RROAR Screening Criteria 1 - SCREEN IN 2 - SCREEN IN 3 - SCREEN IN 4 - SCREEN IN 5 - SCREEN Not Used in Alternative Consider Burdensome OUT Past 3 Years Process Less Frequent Needed for External Users X

Questions in Federal Register NEI Response Notice

1. Which administrative Applicable Regulations regulations should the NRC § 26.417(b)(1) - Call the Ops Ctr within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months after consider changing? Include discovering an act that casts doubt on integrity of the 10 CFR part, section, and the FFD program and any programmatic failure paragraph(s). that might permit undetected [violations of the FFD program]

§ 26.719(b) - Call the Ops Ctr within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months after finding significant FFD policy violations and programmatic failures listed

§ 26.719(c)(2) - Notify NRC within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months after discovery of a false positive error on a blind test sample

§ 26.719(c)(3) - Notify NRC within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months after discovery of a false negative error on a QA check of validity screening tests

2. How should the NRC change Recommendation the regulations? Can the These non-emergency prompt notifications should be regulation be made less eliminated.

burdensome, or should it be eliminated entirely? If possible, provide specific language showing how the regulatory text might be changed to reduce burden.

Describe how the evaluation criteria would apply to the proposed change(s).

Mr. Andrew G. Carrera May 6, 2020 Page 9 Questions in Federal Register NEI Response Notice

3. What is the basis for the Basis proposed change? Provide a It is not clear whether or how the NRC utilizes the rationale for why the information conveyed in the Part 26 prompt notifications requirement might be listed above. We have not found an example of the NRC obsolete or overly taking immediate action, such as commencing a reactive burdensome and any relevant inspection, based on the 24-hour notifications prescribed supporting data. in Part 26.

As noted in PRM-50-116 and elsewhere, we believe that routine communications with onsite resident inspectors, including the residents daily review of plant condition reports, obviate the need for non-emergency notifications to NRC headquarters. Thus, we believe that eliminating the non-emergency 24-hour notifications prescribed in the Part 26 sections listed above would not impair the NRCs ability to protect the public health and safety.

4. What burden is associated Burden with the administrative Quantitatively, the burden of these non-emergency Part requirements? Provide a 26 notifications is not high. The more important burden quantitative basis for the of these non-emergency notifications involves the time burden in terms of costs or and attention of management and operators that would labor hours, if available. be better spent on matters of greater importance to safety. In the interest of protecting the licensees focus on safety, the NRC should consider eliminating the Part 26 non-emergency notifications.

5. How would the suggested Burden Reduction change reduce burden? Eliminating the identified requirements would reduce the Would it result in a onetime administrative and management burden for the licensee reduction in burden, a on an ongoing basis.

reduction in burden for multiple years, or an ongoing reduction in burden? Provide supporting justification.

Mr. Andrew G. Carrera May 6, 2020 Page 10 Table 5: Immediate Notifications and Written Follow-up Reports in Part 37 Applicable NRC RROAR Screening Criteria 1 - SCREEN IN 2 - SCREEN IN 3 - SCREEN IN 4 - SCREEN IN 5 - SCREEN Not Used in Alternative Consider Burdensome OUT Past 3 Years Process Less Frequent Needed for External Users X X Questions in Federal Register NEI Response Notice

1. Which administrative Applicable Regulations regulations should the NRC Immediate Notifications consider changing? Include § 37.57(a) - Licensee immediately notify LLEA after the 10 CFR part, section, and determining that unauthorized entry resulted in paragraph(s). actual or attempted theft, sabotage or diversion of Cat. 1 or 2 rad material. Notify NRC Ops Ctr within four hours after LLEA. 6

§ 37.57(b) - Licensee assess and notify LLEA of any suspicious activity related to theft, sabotage, or diversion of Cat. 1 or 2 rad material. Notify NRC Ops Ctr within four hours after LLEA.

§ 37.81(b) - Shipping licensee notify NRC Ops Ctr within four hours of determining that a shipment of Cat.

2 material is lost or missing. If still missing after 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months , immediately notify NRC Ops Ctr.

§ 37.81(c) - Shipping licensee notify LLEA along shipment route ASAP upon discovery of actual or attempted theft or diversion or suspicious activities related to same for Cat. 1 material.

ASAP after notifying LLEA, licensee shall notify NRC Ops Ctr.

§ 37.81(d) - Shipping licensee to notify NRC Ops Ctr ASAP upon discovering actual or attempted theft of Cat. 2 quantity of radioactive material

§ 37.81(e) - Shipping licensee to notify NRC Ops Ctr and LLEA ASAP upon recovery of lost or missing Cat. 1 quantity of radioactive material

§ 37.81(f) - Shipping licensee to notify NRC Ops Ctr ASAP upon recovery of lost or missing Cat. 2 quantity of radioactive material Follow-up Written Reports 6

Regulations are paraphrased for display purposes; underlining is added by NEI for emphasis.

Mr. Andrew G. Carrera May 6, 2020 Page 11 Questions in Federal Register NEI Response Notice

§ 37.57(c) - File written report with NRC within 30 days after notifying NRC Ops Ctr in 57(a) or (b) above.

§ 37.81(g) - Send written report to NRC within 30 days of calling NRC IAW subsections (a) through (d) above except for suspicious activities reported IAW subsections (c) & (d)

§ 37.81(h) - After submitting written report, report to NRC any additional substantive information within 30 days after learning such information

2. How should the NRC change Recommendations the regulations? Can the 1. Eliminate immediate non-emergency notifications to regulation be made less the NRC Operations Center in favor of promptly burdensome, or should it be notifying NRC (via call to resident inspector), as eliminated entirely? If described in PRM-50-116.

possible, provide specific 2. Eliminate requirement to submit follow-up written language showing how the reports listed in Part 37, recognizing that the regulatory text might be information contained in those reports is commonly changed to reduce burden. retained in licensee records available for NRC Describe how the evaluation inspection.

criteria would apply to the 3. Allow 60 days for preparation of follow-up reports proposed change(s). when necessary, to align with the 60-day schedule for preparation of LERs required by Part 50.73.

3. What is the basis for the Basis proposed change? Provide a 1. When prompt reporting is truly needed by NRC, the rationale for why the prompt report should be made through the NRC requirement might be resident inspector, when feasible. This allows for obsolete or overly more efficient use of resources because the resident burdensome and any relevant inspector is familiar with the plant and situation.

supporting data. Reactor licensees commonly communicate first with their site Resident Inspectors before calling the NRC Operations Center. This makes the call to the Operations Center redundant.

2. Typically, the licensees CAP system is structured to complete necessary causal evaluations in time to support completing an LER (when needed) within 60 days. Similar timing should suffice for written follow-up required by Part 37.

3. Information currently required to be provided in written follow-up reports is available onsite in the CAP system or other site records available for inspection by NRC. In addition, Part 37 written reports might

Mr. Andrew G. Carrera May 6, 2020 Page 12 Questions in Federal Register NEI Response Notice contain safeguards information or information sensitive to local law enforcement which should be restricted from public disclosure.

4. What burden is associated Burden with the administrative As explained previously, the burden associated with requirements? Provide a notifying the NRC through the Operations Center is quantitative basis for the greater than through the resident inspectors. Aligning on burden in terms of costs or a common schedule of 60-days for all written follow-up labor hours, if available. reports simplifies the licensees administrative processes for completing reports and submittals on a consistent schedule. The information NRC needs is readily available for inspection in site records. Thus, eliminating submittal of written reports that are redundant to site records would reduce the administrative burden and distraction imposed on the licensee.

5. How would the suggested Burden Reduction change reduce burden? The burden reduction would be ongoing.

Would it result in a onetime reduction in burden, a reduction in burden for multiple years, or an ongoing reduction in burden? Provide supporting justification.

Mr. Andrew G. Carrera May 6, 2020 Page 13 Table 6: Duplication of Requirements in Part 50, Emergency Plan, and Reporting Rules Applicable NRC RROAR Screening Criteria 1 - SCREEN IN 2 - SCREEN IN 3 - SCREEN IN 4 - SCREEN IN 5 - SCREEN Not Used in Alternative Consider Burdensome OUT Past 3 Years Process Less Frequent Needed for External Users X X X FRN Question NEI Response/Recommendations

1. Which administrative Applicable Regulations regulations should the NRC § 50.36(c)(1) - If safety limit is exceeded, licensee consider changing? Include notify the NRC per 50.72 and submit LER per the 10 CFR part, section, and 50.73. Retain record of event review for three paragraph(s). years after issuing the LER

§ 50.36(c)(2) - If an LCO is not met, notify the NRC per 50.72 and submit LER per 50.73. Retain record of event review for three years after issuing the LER

§ 50.36a(a)(2) - Effluent Report: Licensee submit annual report to NRC that specifies quantity of each principal radionuclide released during the previous 12 months

§ 50.72(a)(1)-(3): Notify NRC Ops Ctr via ENS or phone for: (i) declaring specified emergencies; (ii) declaring specified non-emergencies within three years of date of discovery; or within one hour after notifying state or local agencies

§ 50.72(a)(4) - Activate the ERDS within one hour after declaring an emergency

§ 50, Appendix E, Sec. IV.D.3 - Notify state and local agencies within 15 minutes of declaring an emergency.

§ 50, Appendix E, Sec. VI - Various requirements for the ERDS installation, maintenance, and configuration control

§ 72.75(a) - Part 72 licensee to notify Ops Ctr upon declaration of emergency

2. How should the NRC change Recommendation the regulations? Can the These regulations duplicate requirements in the site regulation be made less emergency plan, technical specifications, or Parts burdensome, or should it be 50.72/50.73 and can be eliminated.

eliminated entirely? If possible, provide specific language showing how the regulatory text might be

Mr. Andrew G. Carrera May 6, 2020 Page 14 FRN Question NEI Response/Recommendations changed to reduce burden.

Describe how the evaluation criteria would apply to the proposed change(s).

3. What is the basis for the Basis proposed change? Provide a The requirements cited above duplicate similar rationale for why the requirements found in reactor technical specifications, the requirement might be station emergency plan, or Parts 50.72 and 50.73.

obsolete or overly Consequently, individuals seeking to identify and burdensome and any relevant understand the complete set of requirements that apply supporting data. to a situation to which the regulations or technical specifications or emergency plan or reporting requirements might apply must sort out the duplications and conflicts. These duplicative requirements should be revised to eliminate overlap and conflicts. This could be done by eliminating the regulations cited above and cleaning up the parallel requirements in the subordinate documents that apply.

4. What burden is associated Burden with the administrative Duplication of requirements creates uncertainty as to requirements? Provide a what the correct regulatory change process is. This quantitative basis for the uncertainty adds time and risk of error to the research burden in terms of costs or necessary to answer questions about applicable labor hours, if available. requirements.

5. How would the suggested Burden Reduction change or reduce burden? Having all requirements in one place or one governing Would it result in a onetime document reduces the risk of error in use and reduction in burden, a maintenance of the requirements.

reduction in burden for multiple years, or an ongoing reduction in burden? Provide supporting justification.

Mr. Andrew G. Carrera May 6, 2020 Page 15 Table 7: Reporting of Items Available in CAP or Site Records Applicable NRC RROAR Screening Criteria 1 - SCREEN IN 2 - SCREEN IN 3 - SCREEN IN 4 - SCREEN IN 5 - SCREEN Not Used in Alternative Consider Burdensome OUT Past 3 Years Process Less Frequent Needed for External Users X X X X FRN Question NEI Response/Recommendations

1. Which administrative Applicable Regulations regulations should the NRC § 50.36(c)(1) - If safety limit is exceeded, licensee notify consider changing? Include the NRC per 50.72 and submit LER per 50.73.

the 10 CFR part, section, Retain record of event review for three years after and paragraph(s). issuing the LER

§ 50.36(c)(2) - If an LCO is not met, notify the NRC per 50.72 and submit LER per 50.73. Retain record of event review for three years after issuing the LER

§ 50.36a(a)(2) - Effluent Report: Licensee submit annual report to NRC that specifies quantity of each principal radionuclide released during the previous 12 months

§ 50.46(a)(3)(ii) (See also Part 50, Appendix K) -

Annually report effects of changes or errors in ECCS evaluation models. If change or error is significant, provide report within 30 days. Change or error not meeting criteria in section (b) [PCT, oxidation, hydrogen, geometry, long term cooling]

is a reportable event per §50.55e, §50.72, and § 50.73

§ 50.54(a)(3) - Changes in QA program description

§ 50.54(p)(2) - Maintain records of changes in security plans listed in Section (p)(1) for three years after and submit a report within two months after

§ 50.54(q)(5) -Retain record of each change to the emergency plan made without prior NRC approval for three years and submit a report on each change within 30 days of making it effective

§ 50.54(w)(3) - Report to NRC on April 1 of each year the current levels of insurance and its sources

§ 50.59(d)(2) - Submit a report on changes, tests and experiments at least every 24 months

§ 50.61(b)(1) - Update the assessment of projected Reference Temperatures whenever there is a significant change in projected values of RT-PTS or

Mr. Andrew G. Carrera May 6, 2020 Page 16 FRN Question NEI Response/Recommendations upon a request for a change in the expiration date for operation of the facility

§ 50.66 - Submit a report describing the plan for thermal annealing at least three years before the limiting fracture toughness criteria would be exceeded

§ 50.71(b) - Submit annual financial report

§ 50.71(e) - Submit updated FSAR periodically

§ 50.73 - Submit LERs for specified events.

§ 55.46(d)(3) - Make results of any uncorrected simulator performance test failures available for NRC review before each operating test or requalification program inspection

§ 70.32(c)(2) - Licensees to keep records of changes in the MC&A program made without prior NRC approval for five years and submit a report describing each change within two or six months of the change (depending on fissile isotopes and enrichments).

§ 70.32(d) - Licensees to keep records of changes in the physical protection plan for material in transit made without prior NRC approval for three years and submit a report describing the changes within two months of the change.

§ 70.32(e) - Licensees to keep records of changes in the security plan made without prior NRC approval for three years and submit a report describing the changes within two months of the change.

§ 70.32(g) - Licensees to keep records of changes in the safeguards contingency plan made without prior NRC approval for three years and submit a report describing the changes within 60 days of the change.

§ 70.32(i) - Licensees to submit a report of changes in the emergency plan made without prior NRC approval within six months of the change.

§ 70.38 - This section specifies a number of documents on decommissioning plans and milestones that are to be submitted to NRC

§ 70.50 - This section specifies immediate and 24-hour reports for a number of occurrences, and written follow-up reports in 30 days.

Mr. Andrew G. Carrera May 6, 2020 Page 17 FRN Question NEI Response/Recommendations

§ 70.72(d)(3) - For all changes that affect the Integrated Safety Analysis summary, the licensee shall submit to NRC annually, within 30 days after the end of the calendar year, revised ISA summary pages 7

§ 72.44(e) - Furnish a report describing each change to the physical security plan within two months after the change is made; keep records of the changes for three years

§ 72.44(f) - Submit a report of EP plan changes to NMSS within six months of the change

§ 72.48(d)(2) - Submit a report on changes, tests and experiments to NMSS at least every 24 months

§ 72.70(c)(6) - Submit updates to the ISFSI FSAR every 24 months

§ 72.75(g) - Submit written follow-up report within 60 days of the initial notification

§ 72.186(b) - Keep records of changes to ISFSI security plan, guard training plan, and safeguards contingency plan for three years and submit a report on each change within two months after making the change

§ 72.212(b)(2) - By letter to NMSS and copy to regional office, register use of each cask within 30 days after using cask to store spent fuel

§ 72.212(b)(4) - By letter to NMSS and copy to regional office, register each loaded cask subject to changes authorized by an amended Certificate of Compliance

§ 74.13(a) - Submit Material Balance Reports for March 31 and September 30 of each year within 30 days after the end of the period

§ 74.15 - This section specifies the conditions under which a licensee is to submit nuclear material transaction reports to NRC Headquarters.

§ 74.17(a) - If subject to 74.31 or 74.33, submit SNM physical inventory summary report within 60 days of starting the inventory required by 74.31(c) or 74.33(c)(4) 7 In SECY-2016-009, Recommendations Resulting from the Integrated Prioritization and Re-Baselining of Agency Activities, dated January 31, 2016, Enclosure 1, Item 113, the NRC staff stated that these reports will no longer be reviewed at NRC Headquarters; therefore, the NRC should eliminate the annual reporting requirement (ADAMS ML16028A212).

Mr. Andrew G. Carrera May 6, 2020 Page 18 FRN Question NEI Response/Recommendations

§ 74.17(b) - If subject to 74.41(a), submit SNM physical inventory summary report within 60 days of starting the inventory required by 74.43(c)(7)

§ 75.34 - This section specifies when and how licensees are to submit inventory change reports to NRC Headquarters.

§ 75.35 - This subject specifies when and how licensees are to submit material status reports no later than 30 days after the start of a physical inventory or at least every 12 months, depending on circumstances.

2. How should the NRC change Recommendations the regulations? Can the These requirements should be revised from submit report regulation be made less to maintain as a record. Where the requirement for burdensome, or should it be submitting a report must be retained in the regulations, eliminated entirely? If the timing for submittal of that report should be set to 60 possible, provide specific days, if it is currently less than 60 days, to align with the language showing how the response time expected for the preparation of LERs. Where regulatory text might be feasible, immediate and 24-hour notifications should be changed to reduce burden. made through the facility resident inspector, rather than Describe how the evaluation through the NRC Operations Center, as described in PRM-criteria would apply to the 50-116.

proposed change(s).

3. What is the basis for the Basis proposed change? Provide a These reports appear to be duplicative of inspection rationale for why the activities in many cases. Much of the information to be requirement might be submitted per the above requirements is available for obsolete or overly inspection onsite. Onsite inspection, in lieu of reporting, burdensome and any should suffice for data that is not needed urgently or not relevant supporting data. changing rapidly. The NRC should scrutinize all of its regulations for submittal of reports to determine whether NRCs way of doing business today still requires the licensee to compose and transmit that formal report, or can NRC meet its needs through onsite inspection of the site records, as we suggest.

Even after submitting formal reports per the above regulations, licensees are sometimes asked to provide copies of those reports as part of inspectors requests for licensee documents relevant to an upcoming inspection. 8 8

NRC Inspection Manual Chapter 0620, Section 04.01.a.2, says that Inspectors should not normally request documents that al-ready exist as NRC official records in ADAMS. [Issue date January 28, 2019, ADAMS ML18254A020]

Mr. Andrew G. Carrera May 6, 2020 Page 19 FRN Question NEI Response/Recommendations This suggests that the effort made by the licensee to prepare and submit the reports to NRC, and efforts by NRC to make those reports available to NRC staff through their document control system, do not actually make a material difference in the NRCs ability to access the information provided in those reports. If so, formal submittal of these reports should not be required.

4. What burden is associated Burden with the administrative The burden of submitting reports that are not actually requirements? Provide a needed by the NRC falls on the licensee in the form of staff quantitative basis for the time to prepare the reports and management time and burden in terms of costs or attention to review and approve the reports for formal labor hours, if available. submittal to NRC.

5. How would the suggested Burden Reduction change reduce burden? Replacing the listed reporting requirements with a Would it result in a onetime requirement to keep the information on file for NRC reduction in burden, a inspection is estimated to reduce onsite burden by reduction in burden for approximately 630 person-hours annually at power reactor multiple years, or an sites.

ongoing reduction in burden? Provide supporting justification.

Mr. Andrew G. Carrera May 6, 2020 Page 20 Table 8: Reporting of Effluent Data versus Retain in Records Applicable NRC RROAR Screening Criteria 1 - SCREEN IN 2 - SCREEN IN 3 - SCREEN IN 4 - SCREEN IN 5 - SCREEN Not Used in Alternative Consider Burdensome OUT Past 3 Years Process Less Frequent Needed for External Users X

FRN Question NEI Response/Recommendations

1. Which administrative Applicable Regulations regulations should the NRC § 50.36a(a)(2) - Effluent Report: Licensee submit consider changing? Include annual report to NRC that specifies quantity of the 10 CFR part, section, and each principal radionuclide released during the paragraph(s). previous 12 months.

§ 70.59 - Effluent monitoring reports due within 60 days after January 1 and July 1 of each year.

§ 72.44(d)(3) - Annually submit report specifying principal radionuclides released in liquid and gaseous effluents

2. How should the NRC change Recommendations the regulations? Can the These requirements should be revised from submit regulation be made less report to maintain as a record. Where timing of the burdensome, or should it be report is less than 60 days from the end of the reporting eliminated entirely? If period, it should be set to 60 days to align with the possible, provide specific response time expected for the preparation of Licensee language showing how the Event Reports.

regulatory text might be changed to reduce burden.

Describe how the evaluation criteria would apply to the proposed change(s).

3. What is the basis for the Basis proposed change? Provide a The information is available in site records accessible for rationale for why the NRC inspection.

requirement might be obsolete or overly burdensome and any relevant supporting data.

4. What burden is associated Burden with the administrative Submitting documents to the NRC adds administrative requirements? Provide a burden to the licensee.

quantitative basis for the burden in terms of costs or labor hours, if available.

Mr. Andrew G. Carrera May 6, 2020 Page 21 FRN Question NEI Response/Recommendations

5. How would the suggested Burden Reduction change reduce burden? Replacing the listed reporting requirements with a Would it result in a onetime requirement to keep the information on file for NRC reduction in burden, a inspection would reduce onsite burden on an ongoing reduction in burden for basis.

multiple years, or an ongoing reduction in burden? Provide supporting justification.

Mr. Andrew G. Carrera May 6, 2020 Page 22 Table 9: Treatment of Current Licensing Basis Information Applicable NRC RROAR Screening Criteria 1 - SCREEN IN 2 - SCREEN IN 3 - SCREEN IN 4 - SCREEN IN 5 - SCREEN Not Used in Alternative Consider Burdensome OUT Past 3 Years Process Less Frequent Needed for External Users X X X X FRN Question NEI Response/Recommendations

1. Which administrative Applicable Regulations regulations should the NRC § 50.54(a)(3) - Changes in QA program description consider changing? Include § 50.54(p)(2) - Maintain records of changes in security the 10 CFR part, section, and plans listed in Section (p)(1) for three years after paragraph(s). and submit a report within two months after

§ 50.54(q)(5) -Retain record of each change to the emergency plan made without prior NRC approval for three years and submit a report on each change within 30 days of making it effective

§ 50.59(d)(2) - Submit a report on changes, tests and experiments at least every 24 months

§ 50.71(e) - Submit updated FSAR periodically

§ 72.44(e) - Furnish a report describing each change to the physical security plan within two months after the change is made; keep records of the changes for three years

§ 72.44(f) - Submit a report of EP plan changes to NMSS within six months of the change

§ 72.186(b) - Submit a report of changes in the physical security plan, guard training plan or safeguards contingency plan within two months of the change

2. How should the NRC change Recommendations the regulations? Can the 1. Reconsider which of these reports is still adding value regulation be made less to the NRCs mission sufficient to require formal burdensome, or should it be submittal to the NRC. If onsite inspection of the eliminated entirely? If information contained in any of these reports is possible, provide specific sufficient to meet NRCs mission, consider eliminating language showing how the the formal submission to NRC.

regulatory text might be 2. For formal submissions that remain essential to the changed to reduce burden. NRCs mission, consider setting a common frequency Describe how the evaluation (e.g., every two years) or deadline for the submittal criteria would apply to the to NRC (e.g., the 60-day interval allowed for proposed change(s). completing a Licensee Event Report).

Mr. Andrew G. Carrera May 6, 2020 Page 23 FRN Question NEI Response/Recommendations

3. Eliminate the 10 CFR 50.59 reporting requirement as duplicative of the requirement to update the UFSAR and the NRCs 50.59 inspection (IP 71111.17).

4. Revise the requirements that allow the licensee to make no changes that decrease effectiveness in administrative plans (e.g., QA, EP, Security) to allow the licensee to make changes that present no substantial decrease in effectiveness. This would provide more flexibility for licensees to find innovative solutions on a risk-informed basis.

3. What is the basis for the Basis proposed change? Provide a With the maturity of the licensee programs subject to rationale for why the these regulations, the NRC should consider means to requirement might be encourage innovation and efficiency improvements that obsolete or overly serve both the NRC and licensee. One means of doing so burdensome and any relevant is to encourage the use of risk-informed approaches in supporting data. determining the threshold of program changes the licensee is allowed to make without prior NRC approval.

For the programs mentioned above, a risk-informed approach could allow the licensee to make changes that present no substantial decrease in effectiveness. For example, SECY-18-0060, Achieving Modern Risk-Informed Regulation, highlights the potential value of risk-informing 10 CFR 50.59. The Executive Director of Operations response to SECY-19-0036 (Application of the Single Failure Criterion to NuScale Power LLCs Inadvertent Actuation Block Valves), Implementing Commission Direction on Applying Risk-Informed Principles in Regulatory Decision Making, dated November 18, 2019 (ADAMS ML1931919C832), further discusses the importance of using risk-informed approaches to review of plant changes. The principles discussed there should be considered in other areas as well.

With inspectors routinely asking for copies of reports submitted by licensees, even though they are available to the NRC staff in ADAMS, it appears that routinely submitting this information to the NRC is redundant and unnecessary.

Mr. Andrew G. Carrera May 6, 2020 Page 24 FRN Question NEI Response/Recommendations

4. What burden is associated Burden with the administrative Typical of the above requirements, the 50.59 reporting requirements? Provide a requirement leads sites to generate a 50.59 summary quantitative basis for the document for the annual report. Additionally, the sites burden in terms of costs or must track the timing of plant changes to ensure they labor hours, if available. comply with the report within deadlines.

5. How would the suggested Burden Reduction change reduce burden? Allowing more flexibility through risk-informed decision-Would it result in a onetime making would reduce burden while focusing on matters of reduction in burden, a the highest risk significance.

reduction in burden for multiple years, or an ongoing reduction in burden? Provide supporting justification.

Mr. Andrew G. Carrera May 6, 2020 Page 25 Table 10: Financial Reporting Applicable NRC RROAR Screening Criteria 1 - SCREEN IN 2 - SCREEN IN 3 - SCREEN IN 4 - SCREEN IN 5 - SCREEN Not Used in Alternative Consider Burdensome OUT Past 3 Years Process Less Frequent Needed for External Users X X X X FRN Question NEI Response/Recommendations

1. Which administrative Applicable Regulations regulations should the NRC § 50.54(w)(3) - Report to NRC on April 1 of each year consider changing? Include the current levels of insurance and its sources the 10 CFR part, section, and § 50.71(b) - Submit annual financial report paragraph(s). § 50.75(e)(3) - COL holder to submit certification of financial assurance for decommissioning at least 2 years before and 1 year before fuel loading.

§ 50.75(f)(1)-(2) - Power reactor licensees report every two years on the status of decommissioning funds

§ 50.82(a)(8)(v) - After submitting its DCE, Licensee must submit annually a financial assurance status report, current through the end of the previous calendar year

§ 72.30(b) & (c) - ISFSI licensee must submit decommissioning funding plan and submit adjustments to it at least every three years

§ 72.30(g)(3) - ISFSI licensee must report replenishments of its decommissioning funds within 30 days if necessary

§ 72.80(b) - ISFSI licensee must furnish its annual financial report unless it already submits a Form 10-Q to the Securities and Exchange Commission.

2. How should the NRC change Recommendations the regulations? Can the 1. Consolidate financial report requirements as much as regulation be made less possible.

burdensome, or should it be 2. Align reporting requirement frequencies as much as eliminated entirely? If possible.

possible, provide specific language showing how the regulatory text might be changed to reduce burden.

Describe how the evaluation criteria would apply to the proposed change(s).

Mr. Andrew G. Carrera May 6, 2020 Page 26 FRN Question NEI Response/Recommendations

3. What is the basis for the Basis proposed change? Provide a Seeking simplicity, convenience, and a holistic view of rationale for why the financial requirements and reporting.

requirement might be obsolete or overly burdensome and any relevant supporting data.

4. What burden is associated Burden with the administrative Simplifying and consolidating financial reporting requirements? Provide a requirements would make it easier to take a holistic view quantitative basis for the of them.

burden in terms of costs or labor hours, if available.

5. How would the suggested Burden Reduction change reduce burden? Result would be an ongoing burden reduction.

Would it result in a onetime reduction in burden, a reduction in burden for multiple years, or an ongoing reduction in burden? Provide supporting justification.

Mr. Andrew G. Carrera May 6, 2020 Page 27 Table 11: IAEA Reporting Requirements Applicable NRC RROAR Screening Criteria 1 - SCREEN IN 2 - SCREEN IN 3 - SCREEN IN 4 - SCREEN IN 5 - SCREEN Not Used in Alternative Consider Less Burdensome OUT Past 3 Years Process Frequent Needed for External Users X X X FRN Question NEI Response

1. Which administrative Applicable Regulations regulations should the NRC § 50.78(a) - Upon request, applicant or recipient of a consider changing? Include license shall submit facility information on Form the 10 CFR part, section, and N-71 and Form AP-A paragraph(s). § 50.78(b) - As required by the Additional Protocol, applicant or licensee shall submit location information per Part 75.11 on Form AP-1

§ 75.7 - Licensee must inform NRC before beginning an activity subject to the US-IAEA Safeguards Agreement or within 30 days of beginning an activity subject to the Additional Protocol

§ 75.10(a) - Applicant or licensee subject to Part 75 shall submit facility information in response to notification from NRC within the period specified by NRC

§ 75.10(c) - Licensee subject to this Part shall submit to NRC information on any modifications affecting response provided in Part 75.10(a) at least 180 days before the mod is to be started

§ 75.11(a) - Applicant or licensee shall submit location information specified in DOC/NRC Form AP-1

§ 75.11(c) - Submit information on DOC/NRC Form AP-1 annually; submit a No change report if the information has not changed; notify NRC when the activity is no longer performed.

2. How should the NRC change Recommendations the regulations? Can the The burden of these requirements falls disproportionately regulation be made less on the few facilities selected for reporting to IAEA. The burdensome, or should it be information required by these regulations is available to eliminated entirely? If the NRC through license amendment requests submitted possible, provide specific to NRC, site records or CAP entries available for NRC language showing how the inspection, and through resident inspector observations regulatory text might be and oversight of their assigned facilities. It is not changed to reduce burden. apparent that the paperwork required by these

Mr. Andrew G. Carrera May 6, 2020 Page 28 FRN Question NEI Response Describe how the evaluation regulations contributes to public health and safety of the criteria would apply to the United States. The NRC should reevaluate its approach to proposed change(s). submitting the information owed to the IAEA and find a less burdensome way to meet the treaty obligations without imposing the weight of the obligation on the selected licensees.

3. What is the basis for the Basis proposed change? Provide a The NRC should seek a more efficient, more equitable rationale for why the way to share the burden of meeting IAEA obligations of requirement might be the United States government.

obsolete or overly burdensome and any relevant supporting data.

4. What burden is associated Burden with the administrative The burden lies in the amount of effort and the timing of requirements? Provide a the special IAEA-negotiated reports required by the NRC.

quantitative basis for the As official submittals to the NRC, these reports must go burden in terms of costs or through the licensees process for data collection, report labor hours, if available. writing, review and validation, and formal concurrence process. The resources spent in this process detract from those available to support other projects that contribute more significantly to public health and safety.

5. How would the suggested Burden Reduction change reduce burden? Result would be an ongoing burden reduction.

Would it result in a onetime reduction in burden, a reduction in burden for multiple years, or an ongoing reduction in burden? Provide supporting justification.

Mr. Andrew G. Carrera May 6, 2020 Page 29 Table 12: Supplemental Responses Applicable NRC RROAR Screening Criteria 1 - SCREEN IN 2 - SCREEN IN 3 - SCREEN IN 4 - SCREEN IN 5 - SCREEN Not Used in Alternative Consider Burdensome OUT Past 3 Years Process Less Frequent Needed for External Users X X FRN Question NEI Response/Recommendations

1. Which administrative Applicable Regulations regulations should the NRC § 21.21(e) - NRC may require those subject to Part 21 consider changing? Include to supply additional information related to a the 10 CFR part, section, and defect or failure to comply.

paragraph(s). § 50.73(c) - NRC may require licensee to submit material to supplement an LER.

2. How should the NRC change Recommendations the regulations? Can the The NRC should consider replacing such regulations as regulation be made less these with a Request for Additional Information (RAI) burdensome, or should it be process like that used in licensing submittals. Replacing eliminated entirely? If the regulations in question with the use of an RAI-like possible, provide specific process would enable licensees to simplify their language showing how the procedures.

regulatory text might be changed to reduce burden.

Describe how the evaluation criteria would apply to the proposed change(s).

3. What is the basis for the Basis proposed change? Provide a We believe the NRC and licensees would benefit from rationale for why the adopting a standard practice for exchange of follow-up requirement might be information that is similar to that followed in licensing obsolete or overly submittals with the use of Requests for Additional burdensome and any relevant Information.

supporting data.

4. What burden is associated Burden with the administrative The burden of the current approach is in maintaining requirements? Provide a procedures and administrative controls tailored to the quantitative basis for the contents, schedules, and delivery requirements associated burden in terms of costs or with each regulation.

labor hours, if available.

5. How would the suggested Burden Reduction change reduce burden? Result would be an ongoing burden reduction.

Would it result in a onetime reduction in burden, a

Mr. Andrew G. Carrera May 6, 2020 Page 30 FRN Question NEI Response/Recommendations reduction in burden for multiple years, or an ongoing reduction in burden? Provide supporting justification.

Mr. Andrew G. Carrera May 6, 2020 Page 31 Table 13: Reporting on Operator Licenses Applicable NRC RROAR Screening Criteria 1 - SCREEN IN 2 - SCREEN IN 3 - SCREEN IN 4 - SCREEN IN 5 - SCREEN Not Used in Alternative Consider Burdensome OUT Past 3 Years Process Less Frequent Needed for External Users X X FRN Question NEI Response

1. Which administrative Applicable Regulations regulations should the NRC § 50.74 - Licensed facility to notify the regional consider changing? Include administrator within 30 days of (a) permanent the 10 CFR part, section, and reassignment of an operator from the position for paragraph(s). which the license was needed; (b) termination; (c) Permanent disability or illness described in Part 55.25

§ 55.25 - Licensed operator to notify NRC within 30 days of learning of diagnosis of a permanent physical or mental condition that causes the operator to fail to meet medical conditions of license

§ 55.53(g) - Licensed operator to notify NRC within 30 days about conviction for a felony.

2. How should the NRC change Recommendations the regulations? Can the The NRC should consider ways to simplify the reporting regulation be made less requirements governing licensed operators to reflect the burdensome, or should it be reality that the operators Part 55 license is tied to the eliminated entirely? If facility licensed under Part 50 for which the operator possible, provide specific works. While it is understandable that NRC would want language showing how the the regulations to enforce notification obligations on the regulatory text might be licensed individual, it should suffice for the obligation of changed to reduce burden. the licensed individual to be to notify the employer of the Describe how the evaluation specified occurrences.

criteria would apply to the proposed change(s).

3. What is the basis for the Basis proposed change? Provide a The proposal seeks to reduce individual reporting directly rationale for why the to the NRC, given the reality that the individual is requirement might be accountable to the facility employing him or her.

obsolete or overly burdensome and any relevant supporting data.

Mr. Andrew G. Carrera May 6, 2020 Page 32 FRN Question NEI Response

4. What burden is associated Burden with the administrative The burden on the individual is small due to the requirements? Provide a infrequency of such obligatory reports.

quantitative basis for the burden in terms of costs or labor hours, if available.

5. How would the suggested Burden Reduction change reduce burden? Result would be an ongoing burden reduction.

Would it result in a onetime reduction in burden, a reduction in burden for multiple years, or an ongoing reduction in burden? Provide supporting justification.

Mr. Andrew G. Carrera May 6, 2020 Page 33 Table 14: Cask Use Applicable NRC RROAR Screening Criteria 1 - SCREEN IN 2 - SCREEN IN 3 - SCREEN IN 4 - SCREEN IN 5 - SCREEN Not Used in Alternative Consider Burdensome OUT Past 3 Years Process Less Frequent Needed for External Users X X FRN Question NEI Response/Recommendations

1. Which administrative Applicable Regulations Identified regulations should the NRC § 71.17(c)(3) - Holder of a general license for an NRC-consider changing? Include approved package shall submit in writing before the 10 CFR part, section, and first use of NRC-approved package the licensees paragraph(s). name, license number and package identification number.

2. How should the NRC change Recommendations the regulations? Can the NRC should reexamine the need for this submittal and regulation be made less explain why this information is still essential to the NRCs burdensome, or should it be mission.

eliminated entirely? If possible, provide specific language showing how the regulatory text might be changed to reduce burden.

Describe how the evaluation criteria would apply to the proposed change(s).

3. What is the basis for the Basis proposed change? Provide a It is unclear whether or how the NRC uses this rationale for why the information today.

requirement might be obsolete or overly If the information submitted with the specified report is burdensome and any relevant not actually used by the NRC to further the agencys supporting data. mission, the report should be eliminated.

4. What burden is associated Burden with the administrative The burden on the licensee is associated with research to requirements? Provide a determine whether the first use obligation applies to the quantitative basis for the specific package in question and then preparing and burden in terms of costs or submitting the required report to the NRC if it does apply.

labor hours, if available.

5. How would the suggested Burden Reduction change reduce burden? The result would be an ongoing burden reduction.

Would it result in a onetime reduction in burden, a

Mr. Andrew G. Carrera May 6, 2020 Page 34 FRN Question NEI Response/Recommendations reduction in burden for multiple years, or an ongoing reduction in burden? Provide supporting justification.

Mr. Andrew G. Carrera May 6, 2020 Page 35 Table 15: Non-Emergency Notifications for ISFSI Facilities Applicable NRC RROAR Screening Criteria 1 - SCREEN IN 2 - SCREEN IN 3 - SCREEN IN 4 - SCREEN IN 5 - SCREEN Not Used in Alternative Consider Burdensome OUT Past 3 Years Process Less Frequent Needed for External Users X X FRN Question NEI Response/Recommendations

1. Which administrative Applicable Regulations Identified regulations should the NRC § 72.75(b)-(d) - Licensee to notify NRC within four, consider changing? Include eight or 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months of events specified in these the 10 CFR part, section, and parts.

paragraph(s).

2. How should the NRC change Recommendations the regulations? Can the Non-emergency notifications should be made through the regulation be made less resident inspector, if applicable, as explained in PRM burdensome, or should it be 116.

eliminated entirely? If possible, provide specific language showing how the regulatory text might be changed to reduce burden.

Describe how the evaluation criteria would apply to the proposed change(s).

3. What is the basis for the Basis proposed change? Provide a As explained in PRM-50-0116, the resident inspectors are rationale for why the most familiar with the facility and its circumstances. This requirement might be makes it more efficient and effective for the licensee to obsolete or overly communicate primarily through their resident inspectors burdensome and any relevant on site, rather than through the NRC Operations Center in supporting data. Rockville, Maryland. Eliminating non-emergency notifications would support keeping management attention on matters of greater safety significance.

4. What burden is associated Burden with the administrative The burden on the licensee lies in the time and attention requirements? Provide a given by management and operators to determining and quantitative basis for the making the specific non-emergency notifications.

burden in terms of costs or labor hours, if available.

5. How would the suggested Burden Reduction change reduce burden? Result would be an ongoing burden reduction.

Would it result in a onetime

Mr. Andrew G. Carrera May 6, 2020 Page 36 FRN Question NEI Response/Recommendations reduction in burden, a reduction in burden for multiple years, or an ongoing reduction in burden? Provide supporting justification.

Mr. Andrew G. Carrera May 6, 2020 Page 37 Table 16: Vessel Coupon Reporting Applicable NRC RROAR Screening Criteria 1 - SCREEN IN 2 - SCREEN IN 3 - SCREEN IN 4 - SCREEN IN 5 - SCREEN Not Used in Alternative Consider Burdensome OUT Past 3 Years Process Less Frequent Needed for External Users X X FRN Question NEI Response

1. Which administrative Applicable Regulations regulations should the NRC § 50, App. H - Submit summary technical report on test consider changing? Include results for each capsule within one year of the 10 CFR part, section, and capsule withdrawal paragraph(s).

2. How should the NRC change Recommendations the regulations? Can the NEI recommends relaxing the 12-month deadline for regulation be made less reporting test results. We understand the staff has burdensome, or should it be proposed relaxing this requirement to 18 months, per eliminated entirely? If NRC staff presentation April 30, 2019 (slide 9), retrieved possible, provide specific from www.regulations.gov, docket NRC-2017-0151, file language showing how the 0010.

regulatory text might be changed to reduce burden.

Describe how the evaluation criteria would apply to the proposed change(s).

3. What is the basis for the Basis proposed change? Provide a It can be difficult to obtain capsule test results and rationale for why the submit them to NRC within the specified 12 months.

requirement might be obsolete or overly burdensome and any relevant supporting data.

4. What burden is associated Burden with the administrative The burden of capsule testing and reporting is both requirements? Provide a technical and administrative.

quantitative basis for the burden in terms of costs or labor hours, if available.

5. How would the suggested Burden Reduction change reduce burden? Result would be an ongoing burden reduction.

Would it result in a onetime reduction in burden, a reduction in burden for

Mr. Andrew G. Carrera May 6, 2020 Page 38 FRN Question NEI Response multiple years, or an ongoing reduction in burden? Provide supporting justification.

Mr. Andrew G. Carrera May 6, 2020 Page 39 Table 17: Letters Approving Proprietary Withholdings Applicable NRC RROAR Screening Criteria 1 - SCREEN IN 2 - SCREEN IN 3 - SCREEN IN 4 - SCREEN IN 5 - SCREEN Not Used in Alternative Consider Burdensome OUT Past 3 Years Process Less Frequent Needed for External Users X X FRN Question NEI Response

1. Which administrative Applicable Regulations regulations should the NRC § 2.390(c)(1) - If the NRC grants the request of an consider changing? Include entity to withhold information from public the 10 CFR part, section, and disclosure per Part 2.390, the Commission will paragraph(s). notify the submitter of its determination to withhold the information from public disclosure.

2. How should the NRC change Recommendations the regulations? Can the NRC should stop sending confirmation letters affirming regulation be made less that the licensee submittal will be withheld from public burdensome, or should it be disclosure. NRC should send a letter only when it eliminated entirely? If disagrees with the licensees request to withhold from possible, provide specific public disclosure (per 2.390(c)(2)).

language showing how the regulatory text might be changed to reduce burden.

Describe how the evaluation criteria would apply to the proposed change(s).

3. What is the basis for the Basis proposed change? Provide a Among the affected licensees, particularly the fuel cycle rationale for why the and materials licensees, the confirmation letters become requirement might be official records required to be retained for the life of the obsolete or overly facility. This creates an incremental additional burden for burdensome and any relevant the licensees records management program.

supporting data.

4. What burden is associated Burden with the administrative The burden for the NRC is the staff time and attention requirements? Provide a needed to prepare and issue the letter. For the licensee, quantitative basis for the the burden is processing and retaining the letter following burden in terms of costs or receipt.

labor hours, if available.

5. How would the suggested Burden Reduction change reduce burden? Result would be an ongoing burden reduction.

Would it result in a onetime reduction in burden, a

Mr. Andrew G. Carrera May 6, 2020 Page 40 FRN Question NEI Response reduction in burden for multiple years, or an ongoing reduction in burden? Provide supporting justification.

Mr. Andrew G. Carrera May 6, 2020 Page 41 Table 18: Medical Requirements for Research and Test Reactor Operators Applicable NRC RROAR Screening Criteria 1 - SCREEN IN 2 - SCREEN IN 3 - SCREEN IN 4 - SCREEN IN 5 - SCREEN Not Used in Alternative Consider Burdensome OUT Past 3 Years Process Less Frequent Needed for External Users X X FRN Question NEI Response

1. Which administrative Applicable Regulations regulations should the NRC § 10 CFR 55.33(a) - The Commission will approve an consider changing? Include initial application for a license pursuant to the the 10 CFR part, section, and regulations...if it finds that (1) the applicants paragraph(s). medical condition and general health will not adversely affect the performance of assigned operator job duties or cause operational errors endangering public health and safety. [Emphasis added by NEI.]

2. How should the NRC change Recommendations the regulations? Can the This requirement should be modified to allow for regulation be made less alternate means for operator medical qualification at non-burdensome, or should it be power utilization facilities (NPUFs), in order to 1) better eliminated entirely? If align with the Atomic Energy Act of 1954, as amended, possible, provide specific which dictates minimum regulations be imposed upon language showing how the NPUFs and 2) align with their inherently low risk-profile.

regulatory text might be One alternative is to incorporate ANSI/ANS Standard changed to reduce burden. 15.4, Section 7.3, which NRC has previously endorsed. It Describe how the evaluation permits in 7.3.1(3), Certification from Level 2 indicating criteria would apply to the that the individual can safely perform his or her assigned proposed change(s). duties. 10 CFR 55.33 could incorporate a new part (c) which states: Medical qualification for facilities licensed under 104(a), (b), or (c) of this part may be justified at the time of initial application and subsequent renewal by having a valid U.S. drivers license, by consent of the Level 2 individual, or in accordance with the established Requalification Plan. An operator shall obtain written statement from a licensed physician, physicians assistant, or nurse practitioner stating the individual can reasonably be expected to perform operations consistent with those necessary to operate a commercial motor vehicle.

Mr. Andrew G. Carrera May 6, 2020 Page 42 FRN Question NEI Response

3. What is the basis for the Basis proposed change? Provide a The basis is explained in full in Enclosure 2.

rationale for why the requirement might be obsolete or overly burdensome and any relevant supporting data.

4. What burden is associated Burden with the administrative The burden for NPUF licensees can be quite significant requirements? Provide a and excessive considering the low risk profile of their quantitative basis for the facilities and operations. See Enclosure 2.

burden in terms of costs or labor hours, if available.

5. How would the suggested Burden Reduction change reduce burden? Result would be an ongoing burden reduction, as Would it result in a onetime explained in Enclosure 2.

reduction in burden, a reduction in burden for multiple years, or an ongoing reduction in burden? Provide supporting justification.

Mr. Andrew G. Carrera May 6, 2020 Page 1 Enclosure 2 Detailed Comments on Medical Requirements for Operators of Research and Test Reactors Non-power Utilization Facilities (NPUFs) carry inherently lower risk portfolios than their industrial counterparts. The largest test reactor currently licensed in the United States has a thermal power rating 1/150th of a full-scale facility while most research reactors are a further 1000-times lower in rating. The active staffing of the research and test reactor fleet tends to range from three to 20 people who may have other responsibilities such as teaching and technical analysis. Any reduction in administrative overhead would immediately provide relief to these licensees.

As part of the Retrospective Review of Administrative Requirements Federal Register Notice (FRN) dated February 4, 2020, the Nuclear Regulatory Commission seeks to identify those requirements that may be obsolete or unnecessarily burdensome. The burden may come in the form of labor or costs.

We urge the NRC to consider revision to Title 10 Code of Federal Regulations, Part 55.33(a) (10 CFR 55.33(a)) to specify alternate means of operator medical qualification at NPUFs. This would reduce the medical burden on licensees and significantly reduce verification requirements by the regulator to validate reported compliance. This change would impact all current and future NPUFs and significantly lessen the initial application process.

The FRN outlined five criteria for evaluating potential changes to administrative regulations. The third of these called for Requirements for reports or records that could be modified to result in reduced burden without impacting programmatic needs, regulatory efficiency, or transparency, through: ...(d) implementing another mechanism that reduced burden for collecting or retaining information.

Regulation 10 CFR 55.33(a) states, The Commission will approve an initial application for a license pursuant to the regulations...if it finds that (1) the applicants medical condition and general health will not adversely affect the performance of assigned operator job duties or cause operational errors endangering public health and safety. (Emphasis added).

Without exception, the research reactor fleet is built to be inherently safe and does not rely on the intervention of an operator to perform or initiate protective actions. Safety Analysis Reports for these facilities demonstrate the overwhelmingly low risk from their operation and the maximum hypothetical accident does not pose a significant risk to the health and safety of the public. Because a lack of action from an operator simply cannot cause operational errors endangering public health and safety (quoted from §55.33(a)(1)), this unnecessary requirement is a strong candidate for exemption among NPUFs. Further supporting the call for this removal, in the Atomic Energy Act of 1954, as amended, Congress directed the Commission to impose only such minimum amount of regulation of the licensee as the Commission finds will permit the Commission to fulfill its obligations under this Act to promote the common defense and security and to protect the health and safety of

Mr. Andrew G. Carrera May 6, 2020 Page 2 the public and will permit the conduct of widespread and diverse research and development.

Minimal health certification is needed to ensure the operation of research reactors is not inimical to public health and safety.

This requirement should be modified for NPUFs to allow alternate means of medical qualification and certification of reliable performance of assigned operator job duties. ANSI/ANS Standard 15.4, Section 7.3, which has been previously endorsed, permits in §7.3.1(3), Certification from Level 2 indicating that the individual can safely perform his or her assigned duties. These alternate means of qualification should be commensurate with the level of reliability required by the task at hand, a determination which should be made by facility personnel. We suggest the addition of part (c) to 10 CFR 55.33 which states:

Medical qualification for facilities licensed under 104(a), (b), or (c) of this part may be justified at the time of initial application and subsequent renewal by having a valid U.S.

drivers license, by consent of the Level 2 individual, or in accordance with the established Requalification Plan. An operator shall obtain written statement from a licensed physician, physicians assistant, or nurse practitioner stating the individual can reasonably be expected to perform operations consistent with those necessary to operate a commercial motor vehicle.

As the regulation currently stands, a 10-kW pool-type reactor located in the heart of a college campus must meet the same medical standards that a 3,000-MW power reactor achieves. This regulation constitutes an undue and unnecessary burden on the research and test reactor community. These research facilities share staff among their universities and the reporting requirements, medical evaluation costs, and other administrative overhead consumes a disproportionate amount of time and resources. Through removal of these requirements, the Commission will ensure it meets its 1954 call from Congress to permit the conduct of widespread and diverse research, as well as furthering the goals of the RROAR Initiative.

ML20128J340

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Subject:

Dear Mr. Carrera:

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