ML24088A181

Ltr to J Semancik NRC Comments on Connecticut Draft Agreement Application

ML24088A181
Person / Time
Issue date:	04/23/2024
From:	Kevin Williams NRC/NMSS/DMSST
To:	Semancik J State of CT, Dept of Energy and Environmental Protection
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ML24088A183	List: ML24088A180 ML24088A181 ML24088A182
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Download: ML24088A181 (1)

Text

Jeffrey Semancik, Director Radiation Division Bureau of Air Management Connecticut Department of Energy and Environmental Protection 79 Elm Street Hartford, CT 06106-5127

SUBJECT:

RESPONSE LETTER WITH COMMENTS ON CONNECTICUT DRAFT AGREEMENT APPLICATION

Dear Mr. Semancik:

We have finished our review of Connecticuts draft application to become an Agreement State in accordance with Section 274b of the Atomic Energy Act, as amended. A U.S. Nuclear Regulatory Commission (NRC) interoffice review team conducted the review following the guidance in NRC Commission Policy Statement Criteria for Guidance of States and NRC in Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through Agreement that provides criteria for new agreements, and the NRC Office of Nuclear Material Safety and Safeguards (NMSS) Procedure SA-700, Processing an Agreement, and its Handbook. The review was conducted to determine whether the proposed Connecticut Agreement State Program (hereafter, the Program) met the evaluation criteria for an Agreement Program that is adequate to protect public health and safety and compatible with NRC requirements. The review team found that the request provided information on all major program elements. Enclosure 1 contains the NRC staffs comments after completing the review.

For your reference, the comments are correlated to the pertinent sections of your request and the pertinent sections of the SA-700 Handbook. The comments are organized under general, specific, and editorial headings. For convenience, Enclosures 2 and 3 contain a markup of comments for the draft agreement and Connecticut regulations.

We would welcome an opportunity to meet with you to discuss our comments and answer any questions concerning our review, the information needed, or steps involved in processing the April 23, 2024

J. Semancik Agreement. Please contact Adelaide Giantelli via email at Adelaide.Giantelli@nrc.gov or Duncan White via email at Duncan.White@nrc.gov to arrange a meeting or conference call.

Sincerely, Kevin Williams, Director Division of Materials Safety, Security, State and Tribal Programs Office of Nuclear Material Safety and Safeguards

Enclosures:

1.

NRC Comments to Connecticut Draft Application 2.

NRC Comments to Proposed Connecticut Agreement 3.

NRC Comments to Connecticut Proposed Agreement Regulations Signed by Williams, Kevin on 04/23/24 Comments on the Draft Connecticut Application for an Agreement Dated February 2024 The draft application (Agencywide Documents Access and Management System Accession Nos. ML24065A111, ML24065A119, ML24065A128, ML24065A134, ML24065A169, ML24065A205, ML24065A207) was reviewed by the following team of NRC staff:

Duncan White, Team Leader and Technical Reviewer, NMSS Huda Akhavannik, Technical Reviewer, NMSS Anita Gray, Technical Reviewer, NMSS Jade Adams, Technical Reviewer, NMSS Ally Marra, Technical Reviewer, NMSS Trisha Gupta Sarma, Technical Reviewer, NMSS Jen Scro, Legal Reviewer, OGC Joseph Azeizat, Legal Reviewer, OGC James Maltese, Legal Reviewer, OGC Shawn Seeley, Technical Reviewer, Region I Lisa Forney, Technical Reviewer, Region I Harry Anagnostopoulos, Technical Reviewer, Region I Jan Nguyen, Technical Reviewer, Region I The review team had 27 specific and 41 comments for consideration across the application. We are not requesting a response to our specific comments, but we ask that you address them in the final application. The comments for consideration are not required to be addressed in the final application but are for your evaluation, as appropriate.

Specific Comments Section 4.1 - Legal Elements 1.

The proposed agreement deviates from the model agreement in Management Directive 5.8, Proposed Section 274b. Agreements with States. The following items need to be changed to align with the model agreement. These comments are also provided in, NRC Comments to Proposed Connecticut Agreement.

a.

Under the first whereas, please delete 11e.(2) as the Agreement is not seeking to assume authority over AEA 11e.(2) material (tailings and waste produced by the extraction or concentration of uranium).

b.

Under the second whereas, please delete the authorization of C.G.S § 3-1 since it does not specify the authority to enter into Agreement. C.G.S. § 22a-152 provides the authority for the Governor to enter an Agreement with the Commission specific to this Agreement.

c.

In Article II, please add, The regulation of byproduct material as defined in Section 11e.(2) of the Act;.

d.

In Article II, please add the following bolded text: The regulation of the disposal of such other byproduct, source, or special [emphasis added] nuclear material as the Commission from time to time determines by regulation or order should, because of the hazards thereof, not to be disposed without a license from the Commission; e.

In Article VI, please change, The Commission shall to, The Commission will to meet the standard agreement language provided in MD 5.9.

f.

In Article VI, please update the last sentence to: The State and the Commission agree to keep each other informed of events, accidents, and licensee performance that may have generic implications or otherwise be of regulatory interest. The previous version had a the before and and licensee.

g.

Please update Article VIII with this missing phrase, the Commission may, after notifying the Governor,.

Section 4.2 - Regulatory Requirements 2.

Connecticuts regulations contain some editorial errors. Enclosure 3, NRC Comments to Connecticut Proposed Agreement Regulations, provides a redline strikeout to show how the state may address these errors. Additionally, please make the following changes:

a.

Connecticut Section 22a-153-1.(b), Table 1 cites 30.4 in the row regarding incorporation by reference of 10 CFR Part 70 instead of 70.4. Please change the reference to 30.4 definitions to 70.4 definitions.

b.

70.23(a)(1) presents some challenges from an incorporation by reference standpoint as there are several substitutions that would need to be made. Given that 70.23(a)(1) is compatibility category D, Connecticut may want to consider not incorporating 70.23(a)(1). Alternatively, Connecticut could add reconciliation language to Section 22a-153-1(b)(4).

c.

Connecticut Section 22a-153-1.(b)(5)(B) contains substitutions to include both NRC and Agreement State requirements. Additional substitutions are needed to account for slight variations of regulatory language in Part 30 and 34. Please update Section 22a-153-1(b)(5)(B) to include " Commission or with an Agreement State and Commission or by an Agreement State to mean, Connecticut Department of Energy and Environmental Protection, the NRC, or Agreement State.

d.

Connecticut Section 22a-153-1.(b)(5)(C) contains substitutions to include both NRC and Agreement State requirements. An additional substitution is needed to account for slight variations of regulatory language in Part 34. Please update Section 22a-153-1(b)(5)(C) to include, A reference to "equivalent regulations of an Agreement State means, NRC regulations in Chapter 10 of the Code of Federal Regulations, or equivalent regulations of an Agreement State.

e.

In Enclosure 3, Connecticut Section 22a-153-1.(b)(5)(T) contains additional citations to sections of 10 CFR Parts 19 and 70 where reference to Atomic Energy Act of 1954 should be substituted for 22a-153 of the Connecticut General Statutes.

Section 4.3 - Licensing 3.

Connecticut Department of Energy and Environmental Protection (CTDEEP) Form 313 contains federal agency under the applicant type. Connecticut would not have authority over a federal agency. Please delete federal agency as an applicant type option in Form 313.

4.

Connecticut procedure 900.2, Renewal of Licenses, Attachment 1, License Expiration Letter template, is missing discussion directing the licensee to proceed to decommissioning. In addition to moving the sources, the letter should indicate that the licensee perform any necessary decontamination of the facility. Please update the letter template to include this information.

5.

In Connecticut procedure 900.3, part of the definition 4.35, Institutional Controls appears to be listed as a separately numbered definition at 4.36. Please combine definition 4.36 with definition 4.35.

6.

Connecticut procedure 900.2, section 6.1.4, describes that, If a timely application is not received by the expiration datethe license is considered to be expiredthe license will also be revised to become a possession only license. However, 900.3, section 5.11.1.1 states, Within fifteen (15) working days following the expiration date of a license without the receipt of a requestlicensee shall be informedan application for license termination shall be submitted within 30 days. Please ensure procedures 900.2 or 900.3 are consistent with each other.

7.

Connecticut procedure 900.5, Renewal Notices, Receipt and Tracking of Licensing Actions, section 6.5.4 states, If no response is received within 60 days, the licensing request may be considered abandoned and any relevant information documented in WBL. This contradicts the 35 days stated in Connecticut procedure 900.1. Please ensure procedures 900.1 and 900.5 are consistent with each other.

Section 4.4 - Inspection 8.

In Chapter 4.4 of the draft application, Table 4.4-1, NRC Documents Serving as Model Guidance for Connecticut, requires several updates. First, please delete the reference to IMC 1220, Processing of NRC Form 241 and Inspection of Agreement State Licensees Operating Under 10 CFR 150.20, as reciprocity has been incorporated into IMC 2800, Materials Inspection Program. Additionally, Connecticut is missing Inspection Procedures 87140-87144. Please add Inspection Procedures 87140-87144 to Table 4.4.-1.

9.

Connecticut appears to be missing procedures for field instrumentation and laboratory analysis (including calibration and quality assurance) and information exchange between inspection and licensing staff. Please update Connecticuts procedures to include these topics.

10. Connecticut procedure 901.1, Scheduling of Inspections, does not directly address scheduling security inspections. Please revise the procedure to either indicate that security inspections will be conducted concurrently with the safety inspections or to provide guidance to schedule separate security inspections.

11. Connecticut procedure 901.3, Performance Based Inspections, section 6.1.1 lists four conditions under which an inspection will be considered to have been performed. As written, it is not clear when these conditions will be met since no qualifying language is used (and/or statements). Please update section 6.1.1 to make clear when an inspection is considered to have been performed.

12. Connecticut procedure 901.6, Tracking Inspections, section 6.3.1.3 states, The date the inspection reply is due should be obtained from the letter and entered into the Radioactive Materials Program WBL database for those licensees who must respond to a Notice of Violation. Please update this section to include discussion for handling a Notice of Warning, which also requires a response from a licensee.

Section 4.5 - Enforcement

13. Connecticut procedure 902.1, section 5.1, describes inspector responsibilities with respect to escalated enforcement violations but does not include non-escalated enforcement violations. Please update this section to include non-escalated enforcement violations.

14. Connecticut procedure 902.1, section 5.1.3.1, mentions issuance of forfeiture but does not describe whether this is forfeiture of the license as a potential enforcement sanction.

Please clarify the intent of issuing forfeiture.

15. Connecticut procedure 902.1, Figure 1, Connecticut Enforcement Process Flowchart, require additional clarification:

a.

It is unclear whether a repetitive, non-escalated violation is elevated to an escalated violation, or only receives a Notice of Violation as the arrow goes in both directions.

b.

It is unclear why a self-corrected, escalated enforcement violation proceeds to a Notice of Violation and Referral for Enforcement while a not self-corrected only gets referred for enforcement action without a Notice of Violation. A not self-corrected violation should result in a more severe violation.

c.

It is unclear whether the (D) for discretion means that discretion is applied or only that it may be applied at this step.

d.

Minor violations appear to always result in a Notice of Violation and never a Notice of Warning.

Please correct the flowchart to add additional clarity and address comments a-d, above.

Also, see editorial comment no. 23.

16. Connecticut procedure 902.1, section 6.2.1.1, describes minor violations being typically non-cited and issued a Notice of Warning. Table 4A Actual or Potential for Harm for Radioactive Materials Security Violations, to Connecticut proposed regulation 22a-6b-8

, contains very high, high, and moderate categories which section 6.2.3.3 describes as similar to NRC Severity Levels I, II, and III, respectively. However, Table 4B sub-factor, Impacts the Commissioners Ability to Perform a Regulatory Function, also contains a low category. Please clarify whether these minor violations are used to disposition a low (Severity Level IV) violation.

17. Connecticut procedure 902.1, section 6.2.1.2, states, Minor violations can only be cited if Please reframe this wording in terms of whether a violation is considered minor.

More specifically, please update the wording to say, Violations can only be considered minor if Additionally, section 6.2.1.2 does not include self-identified as a criterion.

Please update the criteria to include self-identified.

Section 4.6 - Technical Staffing and Training

18. Connecticut draft application section 4.6, Tables 4.6.1-1 and 4.6.1-2, do not appear to include incident and allegations response, generally licensed devices, or decommissioning inspections in the calculations. Please confirm that these activities have been considered as part of the calculation.

19. Connecticut draft application, section 4.6.3, does not provide for a minimum of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of continued learning per person for each 24-month period. Please incorporate this requirement into the application.

20. Connecticut procedure RCP 903.1, page 27, On-the-Job Training (OJT)-9 solely references eye applicators. Please expand this OJT to include any brachytherapy treatments available to patients.

Section 4.7 - Events and Allegations

21. Connecticut procedure RCP 904.1, Management of Allegations, does not provide for periodic updates to the alleger(s). It is appropriate to provide updates every 180 days if not sooner for lengthy and complex investigations. Please update RCP 904.1 to include periodic updates.

22. Connecticut procedure RCP 904.1, section 5.1, does not clearly establish which role determines if the information received meets the definition of an allegation (e.g., is this a responsibility of the SCRP, the LI, or both). Please update 5.1.2.1 to add clarify this responsibility.

23. Connecticut procedure RCP 904.1, section 6.6.4, describes that the Lead Investigator should place a note in the file. Please clarify that that the note should document the agencys final determination on the allegation.

24. Connecticut procedure RCP 904.1 references the Freedom of Information Act (FOIA).

Please revise to clarify that references to FOIA are to the equivalent Connecticut statute and not the federal act.

25. Connecticut procedure RCP 904.2, section 5.1.1.3 states that one of the responsibilities of RMP staff is to Immediately responds to incidents involving radioactive materials, as directed by the RDO. This quoted language may cause confusion because an immediate response may not be necessary for all incidents contingent upon factors including, but not limited to, the risk significance of the event, duration of the event, time of occurrence, and actions taken to address any immediate health and safety concern(s). Please replace the term immediate response with less binding terms such as, respond within the established timeframe as approved by the RDO or RCPD.

26. Connecticut procedure RCP 403 does not provide instruction for when incidents should be reported to the NRC, though the incident reporting form is attached to the procedure and has a line about NRC notification. Please revise the procedure to clarify that the appropriate official will determine if notifications should be made to the NRC within the time period specified in RCP 904.2 Incident Response and perform any other notifications to federal (including NRC, EPA), state, and local agencies, as necessary.

27. Connecticut procedure RCP 403, pages 12-16, includes notation to visit the CRCPD website for the most current version, however the DOT special permit contained in the procedure is out of date. Please refer to the current version. To ensure that staff has consistent access to the current version of the permit, Connecticut can consider updating the DOT Special Permits displayed to the 2023 revision and providing the correct CRCPD link to access the latest version of the form.

Comments for Consideration 1.

All figures in the application need to be legible. For example, section 4.1, Figure 4.1-2, DEEP Office of Legal Counsel from DEEP Intranet, is difficult to read.

Section 4.3 - Licensing 2.

Connecticut draft application, Table 4.3-1, NUREG-1556 VOLUMES, the links to Volumes 13, 14, 16, and 17 are not directly to the volume, but to the page where the volume can be found. Connecticut can consider updating the links to the volumes.

3.

Connecticut draft application Table 4.3-1, NUREG-1556 VOLUMES, mistakenly repeats the Volume 20 title for the Volume 21 entry. Connecticut should update the table to include the correct title for Volume 21.

4.

Connecticut draft application section 4.3.1.1 provides a link to NRCs Medical Uses Licensee Toolkit. Suggest that Connecticut update the application and applicable procedures to also include a link to the NRC 10 CFR 35.1000 Emerging Technologies webpage.

5.

Please update section 4.3 to include a discussion on how Connecticut will address and prioritize converting NRC licenses to Connecticut licenses.

6.

On CTDEEP FORM 313, page 6, Connecticut can consider clarifying if electronic signatures are accepted under Applicant Certification.

7.

On the third row of Table 4.3-2, NRC and Department Forms, the term Authorized Medical Physicists should be singular.

8.

CTDEEP FORM 313 contains an error in the page numbers as the pages are listed out of 13 but should be out of 6. Connecticut should correct this error.

9.

Connecticut procedure RCP 900.1, section 5.3.2.3, Review of Initial Application for License or an Amendment Request, could benefit from adding change of control as an example for consultation. Similarly, in Connecticut procedure RCP 900.4, NRC Licenses Affected by Agreement States, section 4.2 defining licensing actions could also be updated to include transfer of control and change of ownership activities as an example.

10. Please consider updating Connecticut procedure 900.1 to include discussion of exemption requests. Currently, discussion on exemptions is not provided in any of Connecticuts procedures.

11. Connecticut procedure 900.1, section 6.1.8, states, If a response to the deficiency letter is not received within 35 calendar days from the date of the letter, the application can be considered abandoned for failure to provide the requested information and a void letter is issued. Connecticut can consider revising this wording to provide for flexibility to communicate with the licensee prior to voiding the letter or to address situations where a void letter would not be issued such as a renewal or change in RSO.

12. Connecticut procedure 900.1, Connecticut can consider adding guidance for significant licensing actions (e.g., adding a facility, adding a new modality, etc.) to highlight communication between inspection and licensing staff and updating dates of future inspections.

13. Connecticut procedure 900.2, Attachment 2, License Renewal Letter, should also have a version which contains security-headers since a copy of the license is enclosed with the letter.

14. Connecticut procedure RCP 900.1, section 5.3.1.6, contains a priority table listing metrics for licensing actions. Further clarification should be provided in the priority table to resolve apparent conflicts. For example, adding a new RSO is considered high while deleting an RSO is considered low. The NRC staff recommends restructuring by type of licensing category (new, renewal, termination, and amendment.)

15. Connecticut procedure 900.3, License Termination Revocation, contains definitions 4.23, final status survey, and 4.24, final status survey plan, which are not consistent with the Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM).

Please consider updating these definitions to be consistent with MARSSIM found in NUREG-1575.

16. Please consider updating procedure 900.5 and appropriate inspection procedures to include discussion on the use of the National Source Tracking System. Currently, this is not reflected in the draft application or procedures.

Section 4.4 - Inspection

17. Connecticut procedure 901.1, section 6.5.4, is a double-negative sentence and might be considered confusing. Connecticut can consider rewording this sentence.

18. Connecticut procedure 901.1, section 6.8.2.3, discusses possession of Risk Significant Radioactive Materials (RSRM), but this term has never been defined and the topic has not yet been introduced in the procedures. Connecticut can consider defining and clarifying RSRM in their procedures.

19. Connecticut procedure 901.1, section 6.10, uses the term Reduced Inspection while IMC 2800 uses reduced interval inspection. This terminology may inadvertently seem that an inspection effort will be reduced, rather than the licensee will experience more frequent inspections. Connecticut should update the section 6.10 heading to say, Reduced Interval Inspection, to be consistent with IMC 2800.

20. Connecticut procedure 901.3, section 6.1.2, states, An inspection will not be considered to have been performed if the licensee or licensees representatives are not available to assist with the inspection, and the inspector is unable to perform inspection activities.

The and may lead to confusion. Connecticut can consider updating the and to then or as a result.

21. Connecticut procedure 901.3, section 6.3.2, discusses a Notice of Warning without describing any additional information. Please refer to procedure 901.5, Assuring the Technical Quality of Inspections, and 902.1, Enforcement, Escalated Enforcement and Administrative Actions, to provide additional discussion on Notice of Warnings.

22. Connecticut procedure 901.3, section 6.9.2, provides examples of when a team inspection may be appropriate. Connecticut can consider locating this information instead in RCP 901.1, Scheduling Inspections.

Section 4.5 - Enforcement

23. Connecticut procedure 902.1, section 2.0, states, The implementation of specific enforcement actions requires the exercise of discretion However, exercise of discretion typically refers to escalating or mitigating enforcement sanctions depending on the case and would occur for all cases. Connecticut needs to update the language to say, may include the exercise of discretion

24. Consider updating Connecticut procedure 902.1, Figure 1, to be multiple figures: one for minor violation, one for non-escalated enforcement violations, and one for escalated enforcement violations. Alternatively, instructions can be provided depending on the type of violation if Connecticut wants to maintain one figure. These flowcharts can also include the Category of Harm determination in addition to whether it is repetitive, self-identified, and self-corrected.

25. Connecticut procedure 902.1, section 5.1.3.1, mentions issuance of forfeiture. Section 6.4.5 describes other potential escalated enforcement actions such as license suspension, revocation or denial of permits, and registration. Connecticut needs to ensure that consistent language is being used to refer to forfeitures.

26. Connecticut procedure 902.1 contains two sections numbered 6.4.3. Please correct this misnumbering.

Section 4.6 - Technical Staffing and Training

27. Connecticut draft application section 4.6, describes calculations in terms of workdays.

Please include the conversion of hours to Full Time Equivalent (FTE).

28. Connecticut procedure RCP-903.1, section 6.1, should add the clarifying phrase to the end of the paragraph, and will be documented accordingly on a case-by-case basis.

29. Connecticut procedure RCP 903.1, section 6.1.1, and Page 22 of Connecticuts Qualification Journal do not include the review of NUREG 1757, Consolidated Decommissioning Guidance or NUREG 2155, Implementation Guidance for 10 CFR Part 37, Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material. Connecticut should review their procedures and qualification journals to include these volumes or add a more generalized term such as, Review the current, appliable volumes of the NUREG series.

30. In Connecticut procedure RCP-903.1, section 2.1, please remove the word State from the paragraph.

31. Connecticut procedure RCP-903.1, Table 6.1, page 10, the S-201, Materials Control and Security Systems and Principles, and the H-308S, Transportation of Radioactive Materials, courses are not listed for the Decom. Program Manager/Tech. Reviewer.

Connecticut may consider permitting this individual to complete these courses at least optionally as this person is the backup to the Decom. Inspector. The suggested change would also require an update to the qualifications journal portion of the document.

32. Connecticut procedure RCP-903.1, section 6.5.2 can be revised to describe the flexibility of training opportunities. Some opportunities Connecticut may wish to include are Champions Chats and Government to Government Meetings. Connecticut should refer to STC-15-069, Refresher Training for Agreement State Staff, for additional guidance on refresher training.

33. Connecticut procedure RCP 903.1, sections 6.1.4.1.1 and 6.1.4.3.1, uses the term minor duties. This term is unclear. Please clarify what this means with an example.

34. Connecticut can consider clarifying in RCP-903.1 that, as applicable, training is considered completed when the trainee obtains a passing test score to demonstrate competency.

Section 4.7 - Events and Allegations

35. In Connecticut draft application section 4.7.1.2, the paragraph references the term impoundment. In addition to the content provided, it is suggested that CT consider the role of a third-party vendor in handling the source and/or the CRCPD SCATR program, which may be available to provide assistance for disposal of orphaned sources.

36. Connecticut procedure RCP 904.1 does not use consistent terminology in terms of describing response timeframes. For example, it specifies that high-safety significant allegations should be assessed within 30 working days, low-safety significant allegations should be assessed within 30 days and refers to 30 calendar days when specifying the timeframe for alleger to respond or object to allegation being referred to the license. Connecticut should use consistent terms when describing these timeframes.

37. Connecticut procedure RCP 904.1, section 5.1.1.6, advises that all allegations should be documented. Please consider adding a timeframe to document their allegations after receipt.

38. Connecticut should review RCP 904.1, RCP 904.2, and RCP 403 as there appear to be incorrect numbering and page breaks to improve readability.

39. Connecticut procedure RCP 904.3, section 6.3, describes monthly updates for an event.

This may not be appropriate for all events and the document should be updated to indicate that Connecticut will track the event, provide appropriate updates, ensure that each event is complete, and the event closed.

40. Connecticut procedure RCP 904.3, section 6.7, references Appendix G to the SA-300 procedure or the handbook while there is no Appendix G. Please clarify the appropriate reference.

41. Connecticut procedure RCP 403, section 6.3.11, provides a list of common radionuclides found in large sources which may not be exhaustive (e.g., Am-241 or Sr-90 are not in the list). Connecticut should consider revising section 6.3.11 to avoid inadvertently limiting any radionuclides. Connecticut may wish to express this term in terms of activity, exposure rate, etc.

ML24088A183; Ltr ML24088A181 OFFICE NMSS/MSST/SLPB NMSS/MSST

/SLPB NMSS/MSST/SMPB NMSS/MSST NAME HAkhavannik AWhite AGiantelli KWilliams DATE Apr 1, 2024 Apr 1, 2024 Apr 18, 2024 Apr 23, 2024