ML25106A087

Enclosure 1: NRC Comments on Indiana Draft Application for Agreement Dated June 20, 2025

ML25106A087
Person / Time
Issue date:	06/20/2025
From:	Dafna Silberfeld NRC/NMSS/DMSST
To:	Eckstein C State of IN, Dept of Homeland Security
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ML25106A088	List: ML25106A085 ML25106A086 ML25106A087
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Download: ML25106A087 (1)

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Enclosure 1 Comments on the Draft Indiana Application for an Agreement Dated June 20, 2025 The draft application (Agencywide Documents Access and Management System Accession No. ML25079A006) was reviewed by the following team of U.S. Nuclear Regulatory Commission (NRC) staff:

Sherrie Flaherty, Team Leader and Technical Reviewer, Office of Nuclear Material Safety and Safeguards (NMSS)

Ryan Craffey, Technical Reviewer, Region III Duncan White Technical Reviewer, NMSS Lisa Forney, Technical Reviewer, NMSS Anita Gray, Technical Reviewer, NMSS Joan Olmstead, Legal Reviewer, Office of the General Counsel (OGC)

Evan Anderson, Legal Reviewer, OGC Reuben Siegman, Legal Reviewer, OGC James Maltese, Legal Reviewer, OGC Darren Piccirillo, Technical Reviewer, Region III Sara Forster, Technical Reviewer, Region III The review team had three general comments and 94 specific comments across the application.

We are not requesting a specific response to our comments, but we ask that you address them in the final application. In addition, we have 20 editorial comments for your consideration, as appropriate.

General Comments 1.

Please ensure that the application and all associated attachments are proofread prior to submission to account for such items as: superfluous spacing, line breaks, page breaks, formatting for readability, adjustment of columns in tables to prevent word disruptions, and errors in section and page numbering.

2.

Please ensure that all references to phone numbers are correct, for example, in Radioactive Materials Control Program (RMCP) 3.1, Section 3.7, Paragraph 3.7.3, the phone number provided for the U.S. Nuclear Regulatory Commission (NRC) Headquarters Operations Center should be updated to 301816-5100.

3.

When quoting a statutory provision, please ensure that the quotation is easy to identify by using quotation marks or indenting the quote.

Specific Comments Section 4.1 - Legal Elements 1.

The NRC is requesting a letter interpreting Indiana Code (IC) 10-19-12-13 to clarify that the provision does not affect the Indiana Health Departments ability to regulate Atomic Energy Act regulatory materials as contemplated under Indianas proposed Agreement. IC 10 12-13 states, Ordinances, resolutions, or regulations, now or hereafter in effect, of the governing body of a municipality or county or of state agencies, other than the department under Section 5 of this chapter, relating to byproduct, source, and special nuclear materials shall be superseded by this chapter. The NRC sent a comment on July 3, 2023, which stated, You stated that you would check with Indiana Health Department (IHD) to make sure that IC 10-19-12-13 does not unintentionally impact any IHD regulations related to radioactive materials. You also mentioned that the existing legislation could be amended to include a carve-out for IHD if necessary. Indiana previously agreed to amend IC 10-19 13 to address this comment. We later agreed Indiana could send a send a letter interpreting the statutory provision and include it in their final application package instead of amending the provision. The letter can be from the Attorney General or from another party with authority to interpret Indianas statutory provisions.

2.

Please use introductory sentences before the statutory language to provide additional context to the application.

3.

Please include additional relevant enabling statutory authority that is not limited to the radiation control program, such as general statutes relating to ethics, Administrative Procedure Act, and any relevant correspondence relating to resolving legislative legal issues as appropriate.

4.

Section 3.0: Please update the reference to the version of SA700, NRC Office of Nuclear Materials Safety and Safeguards Handbook for Processing an Agreement to the current version dated June 2022.

5.

Section 4.0: The last sentence is repeated in Section 4.1 and can be deleted.

6.

Section 4.1.1.1.a: The citation listed, IC 1019-1211, provides authority to enter into an Agreement. It does not provide authority to establish an Agreement material program and define its structure. Please revise this response.

7.

Section 4.1.1.1.b.: The quoted language authorizes the department to enact rules for licensing but does not specifically authorize the issuance of licenses. Please consider if IC 1019-12-5(c)(3) provides this authority and including this provision in the response.

8.

Section 4.1.1.1.b.3: The existing language is very broad and needs to specify if the State of Indiana recognizing specific licenses issued by the NRC or another Agreement State under reciprocity.

9.

Section 4.1.1.1.b.5: Please change the listed reference IC 10-19-12-6(d) to IC 1019-1211(b) which provides the authority to recognize the NRC licenses transferred to the State of Indiana. In addition, please explain how this section does not affect the NRC or Agreement State licensees based outside of Indiana or the NRC licensees that remain under the NRC jurisdiction, etc.

10. Section 4.1.1.1.c: requests the statutory authority to authorize the program to adopt regulations. The listed provision IC 1019-126(a) provides authority to adopt rules for general and specific licensing of radioactive material or devices or equipment using the radioactive material. IC 1019-125(c)(3) provides general authority to adopt rules and regulations which includes providing for licensing and registration, relating to control of sources of radiation with due regard for compatibility with the regulatory programs of the federal government. Please update this section to include reference to IC 1019-125(c)(3).

11. Section 4.1.1.1.c: The discussion added in paragraphs (1) - (4) are not necessary. Please update this section by deleting these provisions.

12. Section 4.1.1.1.c.1: The paragraph quoting IC 1019-125(c) is related to Section 4.1.1.c.

Please update this section by including a narrative description of the States rulemaking process and include citations as appropriate.

13. Section 4.1.1.1.c.2: The response in this section only covers issuance of licenses and license conditions. It does not adequately cover orders. Please provide additional information regarding the issuance of orders.

14. Section 4.1.1.1.f: Please add narrative text explaining statutory provisions that are quoted in the response. In addition, please indicate if Indiana has provisions to deny, suspend or revoke a license or impose conditions and if the Attorney General has additional authorities to impose sanctions for violations.

15. Section 4.1.1.2.a: The response provided does not include criteria related to the legal authority for the agency to be effective. Please provide additional statutory authority related to items such as developing regulations relating to public health, security, storage, and transportation of radioactive material and other pertinent statutes.

16. Section 4.1.1.2.b: The response does not clearly state whether there is a statutory provision relative to activities reserved to the NRC regulation. Please reference the Indiana statute that clearly reserves certain activities to the NRC. If one does not exist, consider mentioning IC 1019-1211(a) authority to enter into an Agreement and then refer to the draft proposed Agreement provisions that state what regulatory activities stay with the NRC. Additionally, please consider adding IC1019-123(2) mentioning promotion of an orderly pattern of regulation as part of this response.

17. Section 4.1.1.2.b(4): Please add a reference to IC 1019-125(c)(3) and the definitions of general license and specific license to address the criteria in section 4.1.1.2.b(4). Both terms mention authority to possess and use radioactive material.

18. Section 4.1.1.2.d: The response does not clearly explain how IC 1019-126(a) addresses the 4.1.1.2.d criteria. Please explain how IC 1019-126(a) addresses the criteria in this section. Additionally, please consider including IC 1019-126(a)(2) and (4) in the response.

IC 1019-126(a)(4) specifically covers orders. Please include any other statutory provisions that allow issuance of orders to address emergency situations, injunction proceedings, impounding sources of radioactive material, and civil penalties.

19. Section 4.1.1.2.e: Please add a reference to IC 1019-127(c) which grants exemptions from fee requirements.

20. Section 4.1.1.2.f: The reference to IC 1019-129 can be deleted because it is related more to Section 4.1.1.2.g. Please add the ability to inspect for violations in IC 1019-129, the ability to seek injunctive relief under IC 1019-125, and any other general enforcement provisions in your discussion to meet the criteria for this section.

21. Section 4.1.1.2.h: Please explain that Indiana can address an emergency with immediate suspension of a license without prior hearing or issuance of cease-and-desist order under IC 4-21.5-4 to address the criteria in section 4.1.1.2.h. If this is not allowed under IC 412.54, then please explain how Indiana is authorized to conduct an immediate suspension without prior hearing.

22. Section 4.1.1.2.i: Please include Indianas general legislative authority provisions to seek injunctive relief, criminal prosecution and civil/criminal penalties as appropriate.

23. Section 4.1.1.2.i: Please include provisions in IC 1019-126 regarding revoking or suspending a license. In addition, please add the full quote of IC 1019-1218(a) to address the requested authority for this section.

24. Section 4.1.2.1.a: Please include additional information regarding the history of radiation control in the State. Specifically, provide additional information on the regulation of machine produced radiation by the Department of Health, and activities conducted by the Department of Homeland Security related to transportation, event response and orphan source recovery.

25. Section 4.1.2.1.b: Please include additional information under this section related to the regulation of radioactive material in the State. For example, a description of the new organization and how it related to the existing framework under the Fire Marshall.

26. Section 4.1.2.1.c: Please include sections of 10 CFR Indiana will not be incorporating by reference and describe the rules in more detail adding a table listing he sections of the rules, if any.

27. Section 4.1.2.1.c: Figure 6 Only references the Department of Homeland Security Office of General Counsel and references IC 1019-12 relating to the Indianas radiation control program at a very high level. Please expand this section to include a more detailed discussion of other statutory provisions and State Offices and divisions that impact implementation of the States radiation control program (e.g., enforcement or rulemaking).

28. The proposed Agreement deviates from the model Agreement in Management Directive 5.8, Proposed Section 274b. Agreement with States. Please see the changes and comments in that are needed in order to align with the model Agreement.

Section 4.2 - Regulatory Requirements 1.

Section 4.2 second paragraph: Please add the Indiana regulations citation for the Indiana Radioactive Materials Rules.

2.

Section 4.2 second paragraph: Please add 10 CFR Part 171 to the list of 10 CFR Parts incorporated by reference in the Indiana Radioactive Material Rules.

3.

Section 4.2 second paragraph: Please add references to other regulatory provisions that are important to the program (e.g. civil penalty determination and protocols, and the ability of the State to incorporate regulations by reference).

4.

Section 4.2 third paragraph: Please change By incorporating these Parts of the CFR by reference to By incorporating these Parts of the CFR by reference as amended. This change is more appropriate because Indiana has not incorporated by reference identically.

5.

Section 4.2 third paragraph: Because Indiana did incorporate some compatibility D regulations, it should be included in the list. Also consider adding citation to Indianas statutory authority to be able to incorporate regulations by reference.

6.

Section 4.2.1.1 1: The Category A regulations and program elements adopted by the State of Indiana should be essentially identical. Please add essentially before identical.

7.

Section 4.2.1.1 1: Please add 10 CFR Part 171 to the list of Parts incorporating by reference.

8.

Sections 4.2.1.1 2 and 3: The Category B regulations and program elements adopted by the State of Indiana should be essentially identical. Please add essentially to identical.

9.

Section 4.2.1.3: There are two references to IC 1019-125. This regulation only focuses on conflicts between state agencies. Please include Indiana regulations or statutory language that includes a discussion of the elimination of the possibility of duplications, gaps, or conflicts between all entities (federal government, other states, etc.).

10. Section 4.2.1.4: Please change the reference (i.e., Category D) to (i.e., Category H&S).

11. Section 4.2.1.4: Please change Indiana adopts program elements in this category, based on those of the NRC, because to Indiana adopts program elements and their essential objectives in this category, because.

12. Section 4.2.1.4: Please add 10 CFR Part 171 to the list of Parts incorporating by reference.

13. Section 4.2.1.4: In order to match the NRC compatibility requirements, the statement, The State of Indiana incorporates health and safety elements that are identical to those of the NRC should be changed to, The State of Indiana incorporates health and safety elements that embody the basic health and safety aspects of the NRCs program elements

14. Comments to Indiana proposed regulations 290 IAC 3 were done as a separate review in a letter to Courtney Eckstein dated April 9, 2025.

Section 4.3 - Licensing 1.

Please add telephone number and email address for Indiana Department of Homeland Security on page 63.

2.

Please review IN 313 forms: NRC Form 313 contains federal agency under application type. Indiana would not have authority over a federal agency. Please delete federal agency as an applicant type option in Form 313.

3.

Table 4.3.2 of the application lists Indiana form numbers identical to NRC form numbers, but sample Indiana forms submitted do not have form numbers. Please update table with the correct form numbers for the appropriate Indiana forms.

4.

RMCP 1.1 omits any reference to update the National Source Tracking System (NSTS) as part of 10 CFR Part 37 reviews. These updates need to be included in the procedure or elsewhere in the application. Please update procedure RMCP 1.1 and other procedures to include NSTS requirements.

5.

RMCP 1.1 step 3.2.8 states that all submitted and referenced information shall be tied down as license commitments. However, some referenced information may not be licensing commitments. Please update the procedure to specify what submitted information provided by the applicant or licensee will be incorporated into the license and what information will be kept with the licensees file.

6.

RMCP 1.1 includes three levels of review: primary review, secondary review, and supervisory review, but does not specify qualifications for each of the levels of review, and at what point the license can be signed. The procedure needs to be consistent with other Indiana procedures. Specifically, the procedure needs to clarify whether the qualified Senior Health Physicist or the Radiation Control Program Director (RCPD) is the individual designated to sign the licenses. The procedure needs to also confirm that the secondary review will be conducted by a qualified reviewer, prior to signature. Please update the procedure to incorporate the above comments.

7.

RMCP 1.1 omits a section on the review of Decommissioning Cost Estimate and Funding Plan (DCE/FP) actions as part of New License, Renewal, and Amendment reviews.

Although Attachment 1.14 includes a step 3.c. regarding periodic checkups on sufficiency of DCE/FP fund levels, and step 3.a. regarding the review of instruments for adequacy. It does not cover the initial review of the DCE/FP or the maintenance of the instruments..14 also is unclear regarding the availability of funds from the FP, versus other Decommissioning activities. The process for reviewing, approving, and maintaining Decommissioning Financial Assurance needs to be included in the procedure or elsewhere in the application. Please revise the procedure to include initial review of the DCE/FP, maintenance of the instruments, and the availability of the funds from the FP.

8.

RMCP 1.1 omits a section on the review of the need for an emergency plan, for circumstances where possession limits exceed levels outlined in the regulations. Although.14 includes a step 3.b. regarding the review of an emergency plan, it omits a step for the review of an evaluation demonstrating that an emergency plan would not be needed. Please include the process for reviewing an evaluation demonstrating that an emergency plan would not be needed, for circumstances where possession limits exceed levels outlined in the regulations in the procedure, the attachment, or elsewhere in the application.

9.

RMCP 1.1 omits a section on the review of potential Change of Control actions as part of amendment reviews. Although Attachment 1.14 includes a step 3.d. regarding the review of a Change of Control, it does not describe how the program will review, and communicate its review, and notifications of Change of Control. Please include the process for reviewing and consenting to Change of Control notifications, including confirming completion of transactions and updating the license in the procedure or elsewhere in the application.

10. RMCP 1.1 steps 3.5.2 and 3.5.3 describe Decommissioning Licensing actions but make no reference to applying the technical guidance and review outlined in NUREG-1757, Consolidated Decommissioning Guidance. The process for reviewing and approving licensee Decommissioning Plans, use of technical assistance requests to external organizations, and in what cases the Decommissioning program code would be used, needs to be included in the procedure, in a separate procedure, or elsewhere in the application.

Please include the processes described above or reference the procedures in NUREG1757.

11. RMCP 1.1 omits a discussion on exemption requests. Please include the process for reviewing and granting exemptions from State regulations in the procedure or elsewhere in the application.

12. RMCP 1.1 step 3.7.5 states that the RCPD may grant expedited renewals. Indiana should consider the need for an expedited renewal process. Most expedited renewal situations can be covered with an expedited amendment during the renewal process. In lieu of having specific procedures for expedited renewals that are overly complex and rarely necessary, please consider deleting this procedure and using an expedited amendment process.

13. RMCP 1.1 step 4.2.4 states that the oldest application and supporting documents will be deleted once new information is received. Older applications and documents need to be retained until the licensed facility is released for unrestricted use, for decommissioning purposes. Please update the procedure and other sections of the application to ensure that records retention enables Indiana to conduct a Historical Site Assessment for decommissioning, when needed.

14. RMCP 1.1 Attachment 1.14 step 7 refers staff to review escalated enforcement actions for NRC licensees. The internal checklist needs to refer staff to review escalated enforcement actions for Indiana licensees as well as for NRC licensees, with a plan to sunset the reference to the NRC licensees after a certain number of years. Please update the procedure and other Sections of the application to reference Indiana enforcement resources, as well as the NRC resources, and add a footnote as to when the reference to the NRC enforcement resources will be removed from the procedure.

15. RMCP 1.1 Attachment 1.14 step 12 directs staff to ensure that sealed source model numbers are registered. The internal checklist needs to also refer staff to review the Sealed Source and Device Registry to ensure that the requested sealed source model and requested use is consistent with that listed on the current certificate. Please update the checklist to include the review of the Sealed Source and Device Registry.

16. RMCP 1.1 Attachment 1.14 omits a step for signing the license but includes a step 22 to print or email the cover letter and license. For security, unsigned copies of the license and cover letter must not be transmitted to the licensees. Also, the standard format - print or electronic - for the official document and transmittal - needs to be clear. Please update the.14 to clarify when the license will be signed, and whether it will be a wet signature or electronic signature and clarify whether the primary method for transmitting the license will be by email or by hard copy mail.

Section 4.4 - Inspection 1.

Section 4.4.1 of the application needs to more explicitly state how it addresses the areas in Section 4.4.1 of SA700. For example, the application does not explain what this table is or why it is applicable. Please add the intended table and clarify which procedures are intended to address which areas.

2.

The application refers to, but does not have, Sections 4.4.2 or 4.4.3. These are procedures which are necessary for assuring technical quality of inspections and inspection reports and for administrative procedures for inspections. Please include Sections 4.4.2 and 4.4.3 for review.

3.

Table 4.41 does not include NRC Inspection Procedures 87139 through 87144, which were issued in 2022 to provide more specific guidance to inspectors on select authorized uses.

Please add these to the table or create equivalent guidance for inspectors on these uses.

4.

Please remove all references to Inspection Manual Chapter (IMC) 1220, Processing of NRC Form 241. This document was inactivated and is no longer used or maintained.

Guidance on evaluating reciprocity candidates for inspection has since been incorporated into the latest revision of IMC 2800.

5.

Please replace all references to NRC forms and NRC rules with the appropriate Indiana forms and regulations, such as in RMCP 2.3 and RMCP 2.4 Attachment 2.42.

6.

RMCP 2.1 a) Please provide guidance in Section 3.7 for setting the next inspections date.

b) Section 3.9.2.1.7 inaccurately states that the inability to visit a temporary job site during an inspection is an example of poor licensee performance. Please move this Section out of 3.9.2.1 (we recommend making it Section 3.9.1.3 instead).

c)

Please provide guidance in Section 3.9.2.5 for extending inspection intervals for licensees that perform well in inspections.

7.

RMCP 2.2 Section 3.5 states that there are inspection frequencies for special inspections.

There are no such frequencies in RMCP 2.1 (or IMC 2800, Materials Inspection Program),

other than as needed. Please clarify this section or delete the reference from the procedure.

8.

RMCP 2.3 a) Section 1.1.1 defines performance-based in a manner inconsistent with the definition in RMCP 2.6 Section 2.24. Please make both Sections consistent with each other.

b) Sections 3.4 through 3.8 contain guidance on scheduling inspections that is unrelated to the performance-based inspection approach and is duplicative from or belongs in RMCP 2.1 Sections 3.3 through 3.9. Please consider deleting scheduling-related guidance from this procedure and making references to the guidance in RMCP 2.1 as needed instead.

c)

The contents in Section 3.11 are unclear as to how it relates to accomplishing the procedures objectives for security inspections. It appears only to explain that security inspections are required in certain instances. Please revise to discuss or provide examples of how an inspector can/should complete a performance-based inspection of security requirements 9.

RMCP 2.4 a) Section 3.3.2 states that Form 591M shall be used to document clear inspections and Non-Cited Violations but does not clearly state that Form 591M shall be used to document Severity Level (SL) IV violations. The remainder of the application (including the form) suggests that it can be also used for (certain) SL IV violations. In these areas, please clarify if Form 591M can be used for SL IV violations.

b) Attachment 2.41 states that a Clean Inspection Report can provide additional information for higher severity level violations. A Clean Inspection Report normally would not be used when violations are issued. Please clarify if a Clean Inspection Report can be used for recording violations, including higher severity level violations.

10. RMCP 2.6 Sections 2.29 and 2.39 state that reactive inspections are a subset of special inspections, which is contrary to the remainder of the application. For example, RMCP 2.1 and 2.3 explicitly distinguish a reactive inspection from a special inspection (see RMCP 2.1 Section 2.2.2, and RMCP 2.3 Section 2.1.2 and 2.2.2) and RMCP 2.1, 2.2 and 2.3 all provide separate guidance for reactive inspections (Sections 3.5, 3.4 and 3.6, respectively) and special inspections (3.6, 3.5 and 3.7, respectively). Please revise Section 2.29 and 2.39 or the remainder of the application to ensure clear and consistent expectations for the conduct of reactive inspections.

11. RMCP 2.7 a) Section 3.5 states that a narrative inspection report is required for a notice of violation or other enforcement or escalated enforcement action. This is contrary to the guidance in RMCP 2.4 on non-escalated actions. Please clarify the appropriate times that a narrative inspection report is required.

b) It is unclear how or whether the guidance in Section 6.2 should also apply to department forms. Please clarify if this guidance is to be applied to reports generated on department forms, or if other guidance should be followed. Note that the NRC does not apply this guidance for its form reports. Instead, the NRC applies the guidance in IMC 2800 Section 09.02.b and 09.03.b c)

In Sections 12.0, 13.0, and 14.0 it is unclear as to what kind of findings these sections apply to. For example, do they apply to violations as well as observations? Please define finding and observation in RMCP 2.6 for clarity.

Section 4.5 - Enforcement 1.

RMCP 4.1: In the Table of Contents, under 4.0 RMCP Enforcement Process, section 4.2.2 is titled Traditional Enforcement. This is a term used by the NRC to distinguish this process from the Reactor Oversight Process. Because this does not apply to Agreement States, section 4.2.2 may be retitled Severity of Violations. Please update the Table of Contents and section 4.2.2, and remove other references to traditional enforcement.

2.

RMCP 4.1: Section 2.0 includes the phrase a substantially greater protection exists for a known hazard to occur. Please revise protection to potential to be consistent with Section 1.5 of the NRC Enforcement Policy that this sentence comes from.

3.

RMCP 4.1 Sections 3.3 and 3.4: Please clarify the authority of the State Fire Marshal regarding the issuance of enforcement actions for the Agreement program, and the source of this authority. For example, is the Fire Marshal required to review both regular and escalated enforcement actions, or only involved in escalated enforcement actions?

4.

RMCP 4.1 Section 4.2.3: This section seems to be unfinished. Please add full information.

In addition, there is a reference to Section 2.4 which does not appear in the document.

5.

RMCP 4.1 Section 4.2.3: The last paragraph seems to conflict with Section 3.4, in that the description of the process for issuing a cease-and-desist (C&D) order refers to the RCPD and not the State Fire Marshal. Please clarify if this C&D responsibility should be included under Section 3.3 for the RCPD.

6.

RMCP 4.1 Section 4.4.2: This section does not set forth a policy on the use of Alternative Dispute resolution. It refers to an unspecified Agreement without describing how such an agreement can be used to resolve an apparent violation. Please revise.

7.

RMCP 4.1 Section 5.0: The use of the phrase cases involving a lack of reasonable assurance is unclear. The procedure does not indicate how such cases are identified. In the NRC Enforcement Policy, this language is modified as discussed below in Section 4.2, Notices of Violation and Orders to Individuals. The Indiana policy does not reproduce NRCs Section 4.2. Please define reasonable assurance or delete the reference in Section 5.0.

Section 4.6 - Technical Staffing and Training 1.

Section 4.6.1 Organization: Please ensure that an organization chart is included that contains the details needed to articulate the names and job titles of the individuals involved in establishing the Radiation Control Program. This is particularly helpful when referencing the Indiana RMCP and the hierarchy of the Indiana Department of Homeland Security within the state government.

2.

For Section 4.6, please include brief resumes for all full-time and part-time staff included in the full-time equivalent (FTE) calculation. Resumes only need to demonstrate the individual has sufficient experience and training related to program.

3.

Table 4.61 Staff Needs Analysis: Please re-evaluate the time estimates and FTE requirements for the licensing and inspection of different program types with the NRC data provided separately.

4.

The training requirements for qualification of material inspector and license reviewer are not consistent throughout RMCP Procedure 5.1, and the qualification journal in procedure 5.1.-1. The subsequent comments in Section 4.6 of this letter provide specifics to resolve this issue.

5.

Table 4.64 Current Staff Training Completion: Please ensure that the table includes all of the courses needed for formal qualification consistent with IMC 1248, Qualifications Programs for Federal and State Materials and Environmental Management Programs, Appendices A and B.

a.) H122S, Fundamental Health Physics Self-Study, and the subsequent accompaniment course H122 Labs, Fundamental Health Physics Lab Activities, replaced the H122 Fundamental Health Physics and H123 Intermediate Health Physics courses listed in IMC 1248. H122S is listed as a core training course, while H122 Labs is listed as specialized enhanced training. H-122 Labs is completed subsequent to H-122S and both courses are needed to provide staff seeking formal qualification in licensing and inspection that do not have a health physics background. Further, staff may need to complete both of these courses prior to attending the H-201 Advanced Health Physics course. Please ensure that both courses are listed as core training that staff would complete.

b.) It is noted that there are several courses that RMCP staff would still need to attend in order to achieve qualification. Please verify if RMCP staff have completed any additional courses since the last entry on January 26, 2024.

6.

RMCP Procedure 5.1, Revision 0 Qualifications and Training Section 2.0 Responsibilities:

The responsibilities listed for the Health Physicist, Senior Health Physicist, and RCPD do not reflect the full scope of duties and responsibilities associated with each position. Please be advised that SA700 provides guidance on the information needed to assess a new Agreement State programs technical staffing and training program elements. Specifically, Section 4.6.2.1 Information Needed states, The State should submit its position descriptions, and its qualification plan for formal qualification of technical staff members.

Please include position descriptions for all pertinent positions included in the staff needs analysis to ensure clarity of RMCPs staffing and training program elements, and to demonstrate that sufficient staffing was established to account for the responsibilities assumed under the Agreement.

7.

RMCP 5.1 Section 1.4 Definitions: The definitions included in this procedure only include the term Health Physicist, which implies that the procedure only applies to the Health Physicist position. It is unclear if other staff such as the Senior Health Physicists would be involved in activities including but not limited to license review, inspections, advanced training and refresher training. Please review the terms included in the definitions to ensure that they apply to all pertinent staff and is not limited to just one job title. RMCP may wish to add a definition for a term such as staff that refines who the term applies and to provide RCPD with more flexibility to meet operational needs that arise.

8.

RMCP 5.1 Section 3.0 Procedure, Paragraph 3.1.2 Core Training: The core training courses listed are not consistent with those listed in Table 4.64 that are indicated as required for licensing and inspection. Please revise the list in 3.1.2 so that the list of training courses is consistent with Table 4.64.

9.

RMCP 5.1, Section 3.0 Procedure, Paragraphs 3.2.1 Qualified Inspector and/or License Reviewer and 3.3 Specialized Training: The procedure states, The trainee becomes qualified as an inspector or license reviewer in one or more of the various core program categories by obtaining skills as described in the following table by completing the classroom, on-the-job training, and supervised inspections as described in subsection 3.1 items have been completed and signed-off in the trainees Qualification Journal. While specialized training covers more in-depth modalities, there is no reference that the specialized training would need to be completed to obtain formal qualification. For example, the chart lists skills and items (associated training courses) that do not include all of the training courses required under IMC 1248 such as G-109, Licensing Procedures, or specific courses that focus upon a specific modality such as H-305, Safety Aspects of Industrial Radiography, etc. Please revise for consistency and to include all required core training courses needed for individuals to become qualified inspectors and license reviewers into a single table. Further, the table in Paragraph 3.2.1. could be reduced to a list of essential skills, and the specialized skills table in Paragraph 3.3.1 can be converted into the primary list of courses and activities for an individual to become an Indiana materials inspector and license reviewer.

10. RMCP 5.1, Section 3.0 Procedure, Paragraph 3.2.1 Qualified Inspector and/or License Reviewer: This section currently does not clarify the difference between a fully qualified license reviewer or inspector and an interim qualified license reviewer or inspector. This paragraph needs to be revised to indicate full qualification is not obtained by gaining qualification in just one or more categories, but in all key areas. The existing description is consistent with interim qualification and does not address full qualification. Please update this paragraph to indicate the distinction been interim and full qualifications.

11. RMCP 5.1, Section 3.0 Procedure, Paragraph 3.3.1 Specialized Training: The program codes in the chart listed immediately after Section 3.3 Specialized Training is not an exhaustive list of program codes. For example, RMCP lists program code 02120 - Medical Institution - Written Directive Required but omitted program code 02121-Medical Institution

- Written Directive Not Required. However, both program codes are incorporated into.11 RMCP Qualification Journal. Please revise the table in this section to match the list of program codes in the RMCP Qualification Journal.

12. Attachment 5.11 Radioactive Materials Control Program Health Physicist Qualification Journal. Please ensure that the training requirements listed in the procedure are compatible with the content of IMC 1248. While RMCP may have an expectation that staff complete core training in addition to specialized training, there is a disconnect with the chart provided.

It is appropriate to specify all training that would be completed for a modality in addition to the course listed. For example, Broad Type Research and Development is a complex modality that would require training beyond the H301S, Health Physicist Statistics Self Study, course, which is the only course presently listed. This would be more consistent with the Qualification at a Glance.

13. Attachment 5.11 Specialized Training and Skills item 2 Enhanced Security Requirements (10 CFR 37): The S201 training course is a core training course that would be required for formal qualification. Please add this course to the qualification journal.

Section 4.7 - Events and Allegations 1.

RMCP 3.1 Section 3.1: An overall metric to record the intake of an allegation was not established. NRC Management Directive (MD) 8.8,Section II. Allegation Process, Paragraph H.1 uses a five day period to complete the intake process. Please update the RMCP 3.1 to include a timeliness metric for allegation intake.

2.

RMCP 3.1 Management of Allegations Section 2.3 Paragraph 2.3.1: It appears that a word was inadvertently omitted from the RCPD can a designee to perform their assigned duties.

Please rephrase to incorporate the correct word in the sentence.

3.

RMCP 3.1 Section 3.1 Paragraph 3.1.7: This section currently states that if an allegation is determined to be unsubstantiated, the alleger will be notified of its disposition. However, there is not currently any documentation required for unsubstantiated allegations in the procedure. Please incorporate documentation for unsubstantiated allegations in the procedure.

4.

Attachments 3.24 and 3.25: Since RMCP committed to reporting within the time frames established under SA300 Procedure and Handbook on Nuclear Material Event Reporting for the Agreement States Appendix A, this procedure is no longer necessary.

Inconsistencies and the abridgement of descriptions contained within Attachments 3.24 and 3.25 generalize the reporting requirements and could lead to miscommunication or the failure to report events. If RMCP elects to keep the attachment, then it should be revised for consistency with SA300 Appendix A.

Editorial Comments Section 4.1 - Legal Elements 1.

Section 4.1.1.1.d: Suggest editing the language after IC 1019-129 to by adding authorizes representatives of the program to enter premises and conduct inspections.

2. Below IC 1019-1218 - reference to Attachment 4.12 Indiana Radioactive Materials Rules

- this is unnecessary and can be removed.

Section 4.2 - Regulatory Requirements 1.

For clarity, please delete or bold the first paragraph. This paragraph is from SA700 and not part of the Indiana response.

2.

Section 4.2 paragraph two, please change NRC or otherwise states to NRC or otherwise stated.

3.

Section 4.2.1: The last sentence of the third paragraph seems out of place. Please consider removing it.

Section 4.3 - Licensing 1.

Consider adding the NUREG-1556 volume number and title to Table 4.3-1 in case the ML links do not work.

2.

Consider removing NUREG 1556, Vol 8, because Indiana does not have authority over exempt distribution licenses.

Section 4.4 - Inspection 1.

RMCP 2.1: Please delete or amendment from Section 3.4.1.

2. RMCP 2.1 Section 3.10.5: consider changing should not be provided to the licensee/applicant during the site visit to shall not be provided to the licensee/applicant during the site visit.

3.

RMCP 2.2 Section 1.1.2: Please consider beginning with this procedure applies to [the type of inspections you wish to apply them to] for clarification.

4. RMCP 2.3: Consider removing the first sentence in Section 3.1.3 because its purpose is unclear and does not add value to this section.

5. RMCP 2.3 Section 3.1.11 uses the term medical incident. Please clarify the term or, if medical event was intended, please replace with medical event.

6.

RMCP 2.3: Consider moving Sections 3.5.4 and 3.5.5 to RMCP 2.1 Section 3.3, as they are relevant to inspection scheduling and not the performance-based inspection approach.

Section 4.5 - Enforcement 4.

RMCP 4.1: Previous drafts included two attachments with violation examples that may be useful. Consider whether these attachments should be included in the final application.

Section 4.6 - Technical Staffing and Training 1.

RMCP 5.1 Section 3.0: Procedure Section and the Applicability Section. The first paragraph of each Section includes the term Attachment #.#-#. Please update with the appropriate numbering that corresponds with the Health Physicist Qualification Journal.

2.

RMCP 5.1 Section 4.0 Records: Please review the numerical course references listed in the Health Physicist Qualification Journal for consistency with the content of RMCP 5.1, and to ensure that all referenced courses are included.

3..11: The self-study only includes NUREG-1556, Consolidated Guidance about Materials Licenses, and does not incorporate a review of NUREG-1757, Consolidated Decommissioning Guidance, or NUREG-2155, Implementation Guidance for 10 CFR Part 37. Please consider incorporating a review of these documents.

4..11 Items 17: Each item expresses an expectation of what items an individual would need to complete for formal qualification. However, by stating a or adequate substitute, or a and b or adequate substitutes/exceptions for example, there can be confusion by individuals who may wish to qualify. To prevent any confusion, rephrasing is suggested, such as must complete the requirement listed in item a or an approved substitute as documented herein. Further, there may be instances where RMCP may hire staff with specialized training and wish to grant equivalency based upon the scope of prior expertise. It is appropriate to document such decisions in this portion of the document to demonstrate knowledge and training for the individual.

Section 4.7 - Events and Allegations 1.

RMCP 3.2 Incident Response Section 1.3, Paragraph 1.3.1: The definition of Abnormal Occurrence (AO) provided is consistent with the information contained in MD 8.1. However, the State procedure does not include the examples provided in MD 8.1. It may be helpful to provide AO examples in RMCP 3.2, so that an AO could potentially be identified in an expedited manner.

2.

RMCP 3.2 Section 2.2, Paragraph 2.2.4: The disposal of impounded sources can be cost prohibitive. RMCP may wish to include language to the procedure regarding third party vendors in handling source and/or the Conference of Radiation Control Program Directors Source Collection and Threat Reductions program, which may be available to provide assistance with disposal of orphaned sources.

Ltr ML25106A087 OFFICE NMSS/MSST/SLPB NMSS/MSST/SMPB NMSS/MSST/SLPB OCIO/DIME NAME SFlaherty AGiantelli SFlaherty DSilberfeld DATE Apr 16, 2025 Jun 20, 2025 Jun 20, 2025 Jun 20, 2025