ML25049A263

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April 7 2025 Letter to C. Eckstein Re Indiana Proposed Regulations to 10 CFR Parts 19 20 30 31 32 33 34 35 36 37 39 40 61 70 71 and 150
ML25049A263
Person / Time
Issue date: 04/07/2025
From: Adelaide Giantelli
NRC/NMSS/DMSST/ASPB
To: Eckstein C
State of IN, Dept of Homeland Security
References
Download: ML25049A263 (1)
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Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 Courtney Eckstein, Radiation Program Director Indiana Department of Homeland Security 302 W Washington Street, Room E-208 Indianapolis, IN 46204-2739

SUBJECT:

INDIANA PROPOSED REGULATIONS TO 10 CFR PARTS 19, 20, 30, 31, 32, 33, 34, 35, 36, 37, 39, 40, 61, 70, 71, AND 150

Dear Courtney Eckstein:

We have reviewed the proposed Indiana regulations 290 IAC 3-1 through 3-18, received by our office on February 3, 2025. These draft regulations are being resubmitted as part of Indianas draft application to become an Agreement State. Indiana has submitted these draft regulations for public comment. These regulations were reviewed by comparison to the equivalent U.S.

Nuclear Regulatory Commission (NRC) rules in 10 CFR 19, 20, 30, 31, 32, 33, 34, 35, 36, 37, 39, 40, 61, 70, 71, and 150 as identified in the enclosed State Regulation Status (SRS) Data Sheet. We discussed our review of the regulations with you on March 17, 2025.

As a result of our review, we have one compatibility comment and 14 editorial comments that have been identified in Enclosure 1. A redline version of 290 IAC 3 incorporating these comments is provided in Enclosure 2 for your convenience. Please note the sections cited in the comments refer to the updated sections provided in Enclosure 2.

Please note that we have limited our review to regulations required for compatibility and/or health and safety. Under our current procedure, a finding that the Indiana regulations meet the compatibility and health and safety categories of the equivalent NRC regulation may only be made based on a review of the final Indiana regulations. However, we have determined that if your proposed regulations were adopted, incorporating our comments and without other significant change, they would meet the compatibility and health and safety categories established in the Office of Nuclear Material Safety and Safeguards (NMSS) Procedure SA-200, Compatibility Categories and Health and Safety Identification for NRC Regulations and Other Program Elements.

We request that when the proposed regulations are adopted and published as final regulations, a copy of the as published regulations be provided to us for review as part of your final application. As requested in NMSS Procedure SA-201, Review of State Regulatory Requirements, please highlight the final changes and provide a copy to Division of Materials Safety, Security, State and Tribal Programs, NMSS.

April 7, 2025

C. Eckstein If you have any questions regarding the review, the compatibility and health and safety categories, or any of the NRC regulations used in the review, please contact my staff at AgreementStateRegs.Resource@nrc.gov.

Sincerely, Adelaide S. Giantelli, Chief State Agreement and Liaison Programs Branch Division of Materials Safety, Security, State and Tribal Programs Office of Nuclear Material Safety and Safeguards

Enclosures:

1.

Compatibility and Editorial Comments 2.

Redline version of 290 IAC 3 Indiana SRS Data Sheet Signed by Giantelli, Adelaide on 04/07/25 COMPATIBILITY COMMENTS ON INDIANA PROPOSED REGULATIONS STATE SECTION NRC SECTION 10 CFR PART CATEGORY SUBJECT and COMMENTS 1

IAC 3-2-2, Sec. 2. (b) 20 D

Definitions Government agency Indianas proposed regulation 290 IAC 3-1-3, Sec. 3. (a)(7) defines Government agency. Indiana incorporates by reference 10 CFR Part 20 in 290 IAC 3-2-2 Sec. 2. (a) which also includes a duplicative definition of Government agency.

Indiana needs to revise 290 IAC 3 2, Sec. 2. (b)(3) to add Government agency to the list of exclusions from incorporation by reference by making the following revision, 3. 20.1003 (Definitions of Byproduct material, Commission, Decommission, Department, Generally applicable environmental radiation standards, Government agency, Source material, and Special Nuclear Material) to ensure consistency.

EDITORIAL COMMENTS ON INDIANA PROPOSED REGULATIONS STATE SECTION NRC SECTION 10 CFR PART CATEGORY SUBJECT and COMMENTS 1

IAC 3-1-2, Sec. 2.

(a)(3) and (4)

To ensure that Indianas regulations do not inadvertently exclude a reference to the NRC, Commission, or synonymous variation, 290 IAC 3-1-2, Sec. 2.

(a)(3) and (a)(4) needs to include the appropriate references to NRC in Indianas regulatory provisions.

1.

Indiana should revise 290 IAC 3 2, Sec. 2.(a)(3) by adding the phrase U.S. NRC or of an Agreement State, Commission or to an Agreement State, after the phrase [A]ny reference to NRC or

2 STATE SECTION NRC SECTION 10 CFR PART CATEGORY SUBJECT and COMMENTS Agreement State, at the beginning of the regulation to avoid excluding references to NRC from the regulatory provision.

2.

Indiana should revise 290 IAC 3 2, Sec.2 (a)(4) to prevent unintentionally excluding the NRC from the regulation by making the following changes to the paragraph, [A] reference to or equivalent Agreement State regulations or the equivalent Agreement State regulations means NRC regulations in Chapter Title 10 of the Code of Federal Regulations, or equivalent Agreement State regulations. A reference to or equivalent Agreement State requirements or equivalent requirements of an Agreement State means NRC requirements, or equivalent Agreement State requirements. A reference to comparable provisions of an Agreement State means comparable provisions of the NRC or of an Agreement State. A reference to an Agreement State means an Agreement State or the NRC. A reference to "equivalent regulations of an Agreement State, equivalent regulations of the Agreement State or equivalent Agreement State regulations means NRC regulations in Chapter Title 10 of the Code of Federal Regulations, or equivalent regulations of an Agreement State. A reference to equivalent provisions of an Agreement State, equivalent Agreement State provisions or equivalent provisions in Agreement State regulations means equivalent provisions of the NRC or of an Agreement State.

3 STATE SECTION NRC SECTION 10 CFR PART CATEGORY SUBJECT and COMMENTS 2

IAC 3-1-2, Sec.

2(a)(5)

Reference to Advisory Committee on the Medical Uses of Isotopes Indiana 290 IAC 3-1-2, Sec. 2. (a)(5) references the Advisory Committee on the Medical Uses of Isotopes (ACMUI). The regulations incorporated by reference by Indiana do not explicitly mention ACMUI.

Therefore, Indiana can optionally delete this reconciliation language from their regulations. Please note that the enclosed redline and the numbering in the comments below assume that this change has been made.

3 IAC 3-1-2, Sec.

2.(a)(7)

Original version Sec.

2.(a)(8)

Reconciliation language Indiana 290 IAC 3-1-2, Sec. 2. (a)(7) includes 10 CFR 39.51 in the list of regulations where a reference to an Agreement State means an Agreement State or the NRC.

However, Indiana 290 IAC 3-1-2, Sec.

2. (a)(9) also specifically provides reconciliation language for 10 CFR 39.51 to substitute the phrase or by an Agreement State with by the NRC or by an Agreement State.

Indiana should avoid having duplicative provisions by deleting either: 1) the reference to 10 CFR 39.51 in 290 IAC 3-1-2, Sec. 2. (a)(7);

or 2) 290 IAC 3-1-2, Sec. 2. (a)(9) in its entirety.

The following redline strikeout illustrates option 1) by deleting the reference to 10 CFR 39.51 from 290 IAC 3-1-2, Sec. 2. (a)(7) by stating, (7) In 10 CFR 30.32(g); 31.5(b)(1)(ii);

31.5(c)(3)(ii); 31.5(c)(5);

31.5(c)(13)(iv); 31.6; 31.7(a); ;

31.8(b); 31.8(c)(3); 31.10(a);

31.10(b)(1); 31.11(c)(4); 31.11(d)(1);

31.12(c)(4); 32.51a(b); 32.51a(b)(1) and (4); 32.51a(e); 32.52(b);

4 STATE SECTION NRC SECTION 10 CFR PART CATEGORY SUBJECT and COMMENTS 32.52(b)(7); 32.55(d); 32.56; 32.62(e);

32.74(a)(3); 34.89(b)(12); 39.41(f);

39.51; 39.75(e); 40.25(b); 40.25(d)(3);

40.35(d)(2) and (e)(2); 40.55(d)(2);

170.31, Table 1, Category 16, Reciprocity; 170.31(1); and 171.17(b)(2), where a reference is made to an Agreement State, or non-Agreement State it means an Agreement State or the NRC to remove the duplicative provision.

4 IAC 3-1-2, Sec.

2.(a)(11)

Original version Sec. 2 (a)(12)

Reconciliation language and Remove Hyperlink Indiana 290 IAC 3-1-2, Sec. 2. (a)(11) describes reconciliation language to maintain the notification requirements to the NRC in 10 CFR 37.77(a) and (d). However, 10 CFR 37.77 contains other subparagraphs (b) and (c) where the references to NRC should also remain. Additionally, 10 CFR 37.77(a)(1) contains a hyperlink to NRC contacts. To minimize future administrative rulemaking activities, Indiana can remove the explicit reference to the hyperlink.

Indiana can revise 290 IAC 3-1-2, Sec. 2. (a)(11) to address these issues by stating, (11) References to notifications to the NRC in 10 CFR 37.77(a)-(d), including reference to the contact information in 37.77(a)(1) remain. Additionally, the language in 10 CFR 37.77(d) is preserved.

5 IAC 3-1-2, Sec.

2(a)(17)

Original version Sec.

2(a)(18)

Remove references to Subpart H of 10 CFR Part 71 Indiana 290 IAC 3-1-2, Sec. 2.

(a)(17), states that for purposes of 10 CFR Part 71, Subpart H, the listed terms (e.g. certificate of compliance) apply to the NRC. However, these terms should apply to the NRC throughout 10 CFR Part 71. To

5 STATE SECTION NRC SECTION 10 CFR PART CATEGORY SUBJECT and COMMENTS resolve this issue, Indiana should revise 290 IAC 3-1-2, Sec. 2. (a)(17) by removing the reference to Subpart H from the sentence.

6 IAC 3-1-2, Sec.2(a)(1 8)

Original version Sec.

2(a)(19)

Missing words to complete sentence.

Indiana 290 IAC 3-1-2, Sec. 2.

(a)(18), (A)-(D) are missing the phrase are used it to complete the sentences.

To resolve this issue, Indiana can revise 290 IAC 3-1-2, Sec. 2. (a)(18) to state the following:

(18) In 10 CFR 150.20, where the words:

(A) non-agreement states, areas of exclusive federal jurisdiction within agreement states, or offshore waters are used in (a)(1)(i), (ii), (iii); (b), (b)(3), and (b)(4) are used it means The State of Indiana, (B) agreement state license are used it means agreement state license of Nuclear regulatory Commission license, (C) license issued by an agreement state are used it means license issued by an agreement state or the Nuclear Regulatory Commission, (D) license from an agreement state are used it means license from an agreement state of the Nuclear Regulatory Commission.

7 IAC 3-1-2, Sec.

2.(a)(19)

Original version Sec.

2(a)(20)

Reconciliation language Indiana 290 IAC 3-1-2, Sec. 2. (a)(19) lists NRC regulations where references to the Atomic Energy Act of 1954, as amended, and related provisions should mean the Indiana Code 10-19-12, entitled Nuclear Regulatory Agreement. 10 CFR

6 STATE SECTION NRC SECTION 10 CFR PART CATEGORY SUBJECT and COMMENTS 36.15 references to the Atomic Energy Act should also be reconciled to mean the Indiana Code 10-19-23, Indiana 290 IAC 3-1-2, Sec.2(a)(20) fails to include 36.15 on the list of the NRC regulations. To resolve this issue, Indiana should revise 290 IAC 3-1-2 Sec. 2(a)(19) to add 36.15 to the list of NRC regulations as follows:

(19) In 10 CFR 19.15; 19.16; 30.12; 30.13; 30.14; 30.15; 30.18; 30.19; 30.20; 30.21; 30.22; 30.34; 30.41(b)(3); 30.61(b); 36.15; 40.31(d);

40.32(a); 40.41(a), (b), and (e)(4);

40.51(b)(3); 40.71; 70.21(b); 70.31(a);

70.32(a)(3); 70.32(b)(5); 70.36; 70.42(b)(3); 70.81; and 150.20(b),

reference to the Act, Atomic Energy Act of 1954, act, Section 81 of the Act, Section 81 and 82 of the Act, or section 182 of the Act, should mean Indiana Code 10-19-12, entitled, Nuclear Regulatory Agreement.

IAC 3-1-2, Sec.

2.(a)(21) and (23)

Original version Sec.

2(a)(22) and (24)

Remove phrase Indiana 290 IAC 3-1-2, Sec. 2. (a)(21) and (23) contain the phrase

[equivalent state regulations and provisions] which were mistakenly left in Indiana regulations after Indiana added references to the equivalent Indiana code provisions.

To resolve this issue, Indiana should delete the phrase [equivalent state regulations and provision] from 290 IAC 3-1-2, Section (a)(22) and (24).

(21) In 10 CFR 19.11(a)(4); 30.10(b);

40.10(b); 70.10(b); and 71.8(c) the reference to 10 CFR 2, subpart B is replaced with Indiana Code 10-19 18 [equivalent state regulations and provisions].

7 STATE SECTION NRC SECTION 10 CFR PART CATEGORY SUBJECT and COMMENTS (23) In 10 CFR 30.32(f); 30.33; 40.31(f); and 40.32(e) the reference to 10 CFR Part 51 is replaced with Indiana Code 13 [equivalent state regulations and provisions].

9 IAC 3-1-2, Sec.

2.(a)(28) and (32)

Original version Sec.

2(a)(29) and (33)

Reconciliation language needed Various sections of 10 CFR that Indiana has incorporated reference Parts of 10 CFR that cannot be incorporated by Indiana or otherwise adopted, including 10 CFR Parts 21, 60, 63, 73, 74, and 110. Specifically, 290 IAC 3-8-2, Sec. 2(a) incorporates by reference 10 CFR 34.101(a) which references 10 CFR 21.21. Indiana can address this issue by revising 290 IAC 3-1-2, Sec. 2(a)(28) as follows:

(28) In 10 CFR 34.45(a)(9) and in 10 CFR 39.63(l), the phrase as required by part 21 of this chapter and in 34.101(a), the phrase such as § 21.21, are excluded.

Additionally, while Agreement States cannot adopt 10 CFR 110, some regulations require references to 10 CFR 110 provisions for notification purposes. Indiana 290 IAC 3-1-2, Sec. 2(a)(32) refers to part 110.

Indiana needs to change the reference to 10 CFR 110 to provide adequate notification to their licensees. Indiana can address this issue by adding 290 IAC 3-1-2, Sec.

2(a)(32) as follows.

(32) In 10 CFR 31.5(c)(7) and 31.12(c)(3), the phrase part 110 is replaced by 10 CFR part 110.

10 IAC 3-1-2, Sec.

2.(a)(31)

Original version Additional reference needed Indiana incorporates 10 CFR Parts 30 and 32 by reference in 290 IAC 3-4-2 Sec. 2(a) and 290 IAC 3-6-2 Sec.2(a) but excludes 10 CFR 32.11 in 290

8 STATE SECTION NRC SECTION 10 CFR PART CATEGORY SUBJECT and COMMENTS Sec.

2(a)(32)

IAC 3-6-2 Sec. 2(b)(4). Indiana incorporates by reference 10 CFR 32.13 in 290 IAC 3-6-2 Sec. 2(a) which references 10 CFR 30.14 and 32.11. As Indiana does not incorporate by reference 10 CFR 32.11, Indiana needs reconciliation language to say the phrase under 32.11 is replaced by under 10 CFR 32.11. Additionally, 10 CFR 32.13 references 10 CFR 30.14 by referring to it as 30.14 of this chapter. Since Indiana is only incorporating the various parts of 10 CFR and not the NRC chapter, Indiana needs reconciliation language to replace 30.14 of this chapter with 10 CFR 30.14.

Indiana can address these issues by adding 290 IAC 3-1-2 Sec.2(a)(31) as follows:

(31) In 10 CFR 32.13, the phrase 30.14 of this chapter is replaced by 10 CFR 30.14 and the phrase under 32.11 is replaced by under 10 CFR 32.11.

9 11 IAC 3-1-2, Sec. 2.

(a)(33)

Reconciliation language correction Indiana 290 IAC 3-2-2 Sec. 2(a) incorporates by reference 10 CFR 20.1405(b) which references publication of notices in the Federal Register. Indian should add reconciliatory language to reference the appropriate the Indiana State Register. Indiana can address this issue by adding the following provision 290 IAC 3-1-2 Sec. 2(a)(33) which includes adding a reference to the State register where indicated in the brackets below.

(33) References to the Federal Register found in 20.1405(b), means

[substitute reference to State register].

12 IAC 3-2-2, Sec. 2.(b)

Excluding Environmental Protection Agency (EPA) references 290 IAC 3-2-2 (a) incorporates by reference 10 CFR 20.1404(b) which references addressing comments provided by the Environmental Protection Agency (EPA). Indiana should consider excluding this reference to the EPA from incorporation by reference because Indiana is not required to solicit and address comments from the EPA.

Additionally, 290 IAC 3-2-2 (a) also incorporates by reference 10 CFR 20.1405(a)(2) which also references the EPA. To enhance clarity and avoid confusion, Indiana should consider excluding this provision from incorporation by reference because the language concerning separately notifying and soliciting comments from the EPA does not apply to Indiana.

Indiana can address these issues by revising 290 IAC 3-1-2 Sec. 2(b)(8)

10 and adding Sec.2(b)(9) to exclude 20.1405(a)(2) as noted below.

8. 20.1404(b) reference to the Environmental Protection Agency
9. 20.1405(a)(2) 13 IAC 3-16-2, Sec. 2.(b)

Remove 10 CFR 71.1 Indiana 290 IAC 3-16-2, Sec. 2. (b)(2) excludes 10 CFR 71.1 from incorporation by reference. Indiana already provides reconciliation language for communications and reports to be directed to Indiana in 290 IAC 3-1-2, Sec. 2. (a)(6)(B) that specifically requires submissions under to 10 CFR 71.17(c) to be sent to the NRC using the method listed in 10 CFR 71.1(a). Therefore, Indiana cannot exclude 10 CFR 71.1 from incorporation by reference. Indiana can address this issue by removing 10 CFR 71.1 from the list of excluded regulations in 290 IAC 3-16-2, Sec. 2.

(b)(2).

14 IAC 3-1-2 Sec 2.

(a)(5)(B) -

Old version Sec 2.

(a)(6)(B)

IAC 3-1-2 Sec 2.

(a)(19) - Old version Sec

2. (a)(20)

IAC 3-1-3, Sec.

3.(a)(19)

IAC 3-3-1 Various correction of typos, misspellings, and grammatical errors appropriate metho listed in corrected to appropriate methods listed in Close quote at the end of Nuclear Regulatory Agreement IAC 3-1-3, Sec. 3. (a)(19) is missing its closing parenthesis.

Missing period at the end of the

11 Sec. 1(b)

IAC 3-5-1 Sec. 1(b)

IAC 3-17-2 Sec. 2.(b)(3)

IAC 3-18-4 Sec. 3.(a) sentence Missing period at the end of the sentence Remove and after Source Material In the phrase which are valued at an equal of greater amount, change of to or Title 290. Department of Homeland Security Article 3. Standards for Protection Against Radiation Rule 1.

General Provisions 290 IAC 3-1-1. Applicability Sec. 1 (a) This Article, except as otherwise specifically provided, applies to all persons who use, store, produce, transport, possess or dispose of radioactive materials within the state of Indiana.

(b) This Article does not apply to any person to the extent such a person is subject to regulation by the U.S. Nuclear Regulatory Commission (NRC).

290 IAC 3-1-2 Reconciliation of Differences Sec. 2. (a) To reconcile differences between this Article and the incorporated language, the following words and phrases shall be substituted for the language in the incorporated material as follows:

(1) Unless otherwise specified in this section, any reference to Department means Indiana Department of Homeland Security.

(2) A reference to NRC or Commission, or synonymous variations thereof, Regional Office, Director, Office of Nuclear Material Safety and Safeguards or his/her designee, United States Nuclear Regulatory Commission, U.S. Nuclear Regulatory Commission, Administrator of the appropriate Regional Office, Regional Administrator, or Atomic Energy Commission, means the Indiana Department of Homeland Security, except when used in:

(A) the definition of Agreement State in 10 CFR 30.4, 35.2, 37.5. 40.4, 70.4, and 150.3; (B) the definition of Sealed Source and Device Registry in 10 CFR 32.2 and 35.2; (C) 10 CFR 35 when referring to the NRC's Medical Uses Licensee Toolkit web page; (D) the reference to master material license or licensee in 10 CFR 35; (E) the definition of Fingerprint orders in 10 CFR 37.5; (F) 10 CFR 37.25(b)(2);

(G) 10 CFR 37.27(a) and (c);

(H) 10 CFR 37.29(a)(1) and (a)(7);

(I) 10 CFR 37.31(d);

(J) the reference to the NRCs license verification system in 10 CFR 37.71(a)-(c);

(K) 10 CFR 39.63(l);

(L) 10 CFR 40.4; (M) 10 CFR 40.35(f);

(N) 10 CFR 61.55(a)(2)(iv);

(O) 10 CFR 70.19(a)(2), (a)(3), and (c)(3);

(P) 10 CFR 71.17(e);

(M) 10 CFR 71.88(a)(4);

(M) 10 CFR 71.93(c);

(O) The definitions of Certificate Holder and Certificate of Compliance in 10 CFR 71.4; (3) Any reference to NRC or Agreement State, U.S. NRC or of an Agreement State, Commission or to an Agreement State, Commission or the licensing agency of an Agreement State, Commission or the appropriate agency of an Agreement State, Commission or the Atomic Energy Commission or an Agreement State, Atomic Energy Commission, the Commission, or an Agreement State, with the Commission or

2 with an Agreement State, U.S. Nuclear Regulatory Commission or the legally binding requirements issued by Agreement States, Commission or Agreement State, or Commission or an Agreement State means the Indiana Department of Homeland Security, the NRC, or Agreement State; (4) A reference to or equivalent Agreement State regulations or the equivalent Agreement State regulations means NRC regulations in Chapter Title 10 of the Code of Federal Regulations, or equivalent Agreement State regulations. A reference to or equivalent Agreement State requirements or equivalent requirements of an Agreement State means NRC requirements, or equivalent Agreement State requirements. A reference to comparable provisions of an Agreement State means comparable provisions of the NRC or of an Agreement State. A reference to an Agreement State means an Agreement State or the NRC. A reference to "equivalent regulations of an Agreement State, equivalent regulations of the Agreement State or equivalent Agreement State regulations means NRC regulations in Chapter Title 10 of the Code of Federal Regulations, or equivalent regulations of an Agreement State. A reference to equivalent provisions of an Agreement State, equivalent Agreement State provisions or equivalent provisions in Agreement State regulations means equivalent provisions of the NRC or of an Agreement State.

(5) Any reference to the Advisory Committee on the Medical Uses of Isotopes (ACMUI) shall be deemed to be a reference to the Departments Radiation Advisory Committee.

(5) Any notifications, communications, reports, correspondence, or oath and affirmations referenced in the incorporated sections of the Code of Federal Regulations shall be directed to the Department using the contact information specified in section 5 of this chapter. However, (A) fingerprints for FBI criminal history records check and related fees shall be submitted to the NRC in accordance with 10 CFR 37.27; (B) the submission required before the first use of an NRC approved package shall be sent in accordance with 10 CFR 71.17(c)(3), to the NRC, ATTN:

Document Control Desk, Director, Division of Spent Fuel Storage and Transportation, Office of Nuclear Material Safety and Safeguards, using the appropriate method listed in 10 CFR 71.1(a), the licensees name and license number and the package identification number specified in the package approval; (6) Any requirement to utilize an NRC Form may also be satisfied by use of an equivalent form approved by the Department.

(7) In 10 CFR 30.32(g); 31.5(b)(1)(ii); 31.5(c)(3)(ii); 31.5(c)(5); 31.5(c)(13)(iv); 31.6; 31.7(a); ; 31.8(b); 31.8(c)(3); 31.10(a); 31.10(b)(1); 31.11(c)(4); 31.11(d)(1); 31.12(c)(4);

32.51a(b); 32.51a(b)(1) and (4); 32.51a(e); 32.52(b); 32.52(b)(7); 32.55(d); 32.56; 32.62(e); 32.74(a)(3); 34.89(b)(12); 39.41(f); 39.51; 39.75(e); 40.25(b); 40.25(d)(3);

40.35(d)(2) and (e)(2); 40.55(d)(2); 170.31, Table 1, Category 16, Reciprocity; 170.31(1); and 171.17(b)(2), where a reference is made to an Agreement State, or non-Agreement State it means an Agreement State or the NRC; (8) In 10 CFR 31.6 and 31.8(a)(1), where the words any non-agreement state or offshore waters are used substitute the words State of Indiana; (9) In 10 CFR 39.51, where the phrase or by an Agreement State is used, substitute the words by the NRC or by an Agreement State; (10) In 10 CFR 70.19(a)(1), reference to a non-agreement State means the State of Indiana; (11) In 10 CFR 37.77(a)(1), the following language is preserved; The contact information including telephone and mailing addresses, of governors and governors designees, is available on the NRCs Web site at https://scp.nrc.gov/special/designess.pdf. A list of the contact information is also

3 available upon request from the Director, Division of Materials Safety, Security, State, and tribal Programs, Office of Nuclear Materials Safet and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 2055-0001. Additionally, the language References to notifications to the NRC in 10 CFR 37.77(a)-(d), including reference to the contact information in 37.77(a)(1) remain. Additionally, the language in 10 CFR 37.77(d) is preserved.;

(12) Required statements for labeling referenced in 10 CFR are preserved.

(13) In 10 CFR 71.97(c)(3)(ii) and (iii) and in 71.97(f) the language is preserved; (14) In 10 CFR 30.12; 30.41(b)(1), the definition of Department of Energy in 10 CFR 40.4 and 70.4; 40.11; 40.14(c); 40.51(b)(1); 70.11; and 70.42(b)(1); the word Department means the US Department of Energy; (15) In 10 CFR 30.41(b)(2); 40.51(b)(2); and 70.42(b)(2), agency in any Agreement State means agency in any Agreement State or agency under NRC jurisdiction.

(16) In 10 CFR 30.41(b)(4); 40.51(b)(4); and 70.42(b)(4); where a reference is made to any person in an Agreement State, subject to the jurisdiction of that State, who has been exempted from the licensing requirements and regulations of that State it means, any person in an Agreement State or in NRC jurisdiction, subject to the jurisdiction of that State or the NRC, who has been exempted from the licensing requirements and regulation of that State or the NRC.

(17) For purposes of 10 CFR Part 71, Subpart H, and 10 CFR 170 and 171 only, the terms certificate of compliance, compliance holder, certificate holder, or applicant for certificate of compliance apply to the NRC as they are the sole authority for issuing a package certificate of compliance.

(18) In 10 CFR 150.20, where the words:

(A) non-agreement states, areas of exclusive federal jurisdiction within agreement states, or offshore waters are used in (a)(1)(i), (ii), (iii); (b), (b)(3),

and (b)(4) are used it means The State of Indiana, (B) agreement state license are used it means agreement state license of Nuclear regulatory Commission license, (C) license issued by an agreement state are used it means license issued by an agreement state or the Nuclear Regulatory Commission, (D) license from an agreement state are used it means license from an agreement state of the Nuclear Regulatory Commission.

(19) In 10 CFR 19.15; 19.16; 30.12; 30.13; 30.14; 30.15; 30.18; 30.19; 30.20; 30.21; 30.22; 30.34; 30.41(b)(3); 30.61(b); 36.15; 40.31(d); 40.32(a); 40.41(a), (b), and (e)(4);

40.51(b)(3); 40.71; 70.21(b); 70.31(a); 70.32(a)(3); 70.32(b)(5); 70.36; 70.42(b)(3);

70.81; and 150.20(b), reference to the Act, Atomic Energy Act of 1954, act, Section 81 of the Act, Section 81 and 82 of the Act, or section 182 of the Act, should mean Indiana Code 10-19-12, entitled, Nuclear Regulatory Agreement.

(20) References to parts of Chapter 10 of the Code of Federal Regulations that remain under the NRCs regulatory authority (e.g., 10 CFR Parts 50, 52, 54, 60, 63, 72, 76, and 110; and the phrase common defense and security) are not incorporated.

(21) In 10 CFR 19.11(a)(4); 30.10(b); 40.10(b); 70.10(b); and 71.8(c) the reference to 10 CFR 2, subpart B is replaced with Indiana Code 10-19-12-18 [equivalent state regulations and provisions].

(22) In 10 CFR 40.31(c), the reference to 10 CFR Parts 2 and 9, relating to public records, is replaced with Indiana Code 5-14-3. Similarly, in 10 CFR 70.21(d), the reference to part 2 is replaced with Indiana Code 5-14-3.

(23) In 10 CFR 30.32(f); 30.33; 40.31(f); and 40.32(e) the reference to 10 CFR Part 51 is replaced with Indiana Code 13[equivalent state regulations and provisions].

(24) In 10 CFR 71.101(c)(1), using an appropriate method listed in § 71.1(a), each

4 licensee shall file a description of its quality assurance program, including a discussion of which requirements of this subpart are applicable and how they will be satisfied, by submitting the description to the address specified in 290 IAC 3-1-4(a).

(25) In 10 CFR 61.55(a)(2)(iv) the reference to part 60 or 63 of this chapter is replaced with 10 CFR 60 or 63.

(26) In 10 CFR 39.11, reference to the definition of person in 10 CFR 30.4 is a reference to the definition of person in Indiana Code 10-19-12.

(27) In 10 CFR 31.2; 31.5(b)(10); 31.7(b); 31.8(c); 31.11(f); 31.12(b); 40.13; 40.22(d);

and 70.19(c) the reference to 21 of this chapter is replaced by 10 CFR Part 21.

(28) In 10 CFR 34.45(a)(9) and in 10 CFR 39.63(l), the phrase as required by part 21 of this chapter and in 34.101(a), the phrase such as § 21.21, are excluded.

(29) Any reference to part 73 of this chapter is a reference to 10 CFR Part 73.

(30) In 10 CFR 150.20, 74.11, 74.15, and 74.19 of this chapter is replaced by 10 CFR 74.11, 74.15, and 74.19.

(31) In 10 CFR 32.13, the phrase 30.14 of this chapter is replaced by 10 CFR 30.14 and the phrase under 32.11 is replaced by under 10 CFR 32.11.

(32) In 10 CFR 31.5(c)(7) and 31.12(c)(3), the phrase part 110 is replaced by 10 CFR part 110.

(33) References to the Federal Register found in 20.1405(b), means [substitute reference to State register].

290 IAC 3-1-3 Definitions Sec. 3. (a) The following definitions apply, as indicated, throughout this Article:

(1) "Civil penalty" means any monetary penalty levied on a licensee or registrant because of violations of statutes, regulations, licenses, or registration certificates, but does not include criminal penalties.

(2) "Closure" or "site closure" means all activities performed at a waste disposal site, such as stabilization and contouring, to assure that the site is in a stable condition so that only minor custodial care, surveillance, and monitoring are necessary at the site following termination of a licensed operation.

(3) "Decommissioning" means final operational activities at a facility to dismantle site structures, to decontaminate site surfaces and remaining structures, to stabilize and contain residual radioactive material, and to carry out any other activities to prepare the site for post-operational care.

(4) "Department" means the Indiana department of homeland security established by IC 10- 19-2-1.

(5) "Registration" means registration with the department in accordance the Indiana Administrative Procedure Act, IC 4-21.5 and IC 4-22.

(6) "General license" means a license effective under regulations promulgated by the department without the filing of an application with the department or the issuance of licensing documents to particular persons to transfer, acquire, own, possess, or use quantities of, or devices or equipment utilizing, radioactive material.

(7) Government agency means any board, commission, department, agency, authority, or other entity, by whatever name designated, exercising a portion of the executive, administrative, or legislative power of the state.

(8) "High-level radioactive waste" means:

(A) irradiated reactor fuel;

5 (B) liquid wastes resulting from the operation of the first cycle solvent extraction system, or equivalent, and the concentrated wastes from subsequent extraction cycles, or equivalent, in a facility for reprocessing irradiated reactor fuel; and (C) solids into which such liquid wastes have been converted.

(9) "Low-level radioactive waste" means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material.

(10) "Disposal of low-level radioactive waste" means the isolation of such waste from the biosphere by emplacement in a land burial facility.

(11) "Sources of radiation" means collectively, radioactive material and radiation generating equipment.

(12) "Radiation" means ionizing radiation and nonionizing radiation.

(13) "Ionizing radiation" means gamma rays and x-rays, alpha and beta particles, high-speed electrons, neutrons, protons, and other nuclear particles; but not sound or radio waves, or visible, infrared, or ultraviolet light.

(14) "Nonionizing radiation" means the following: (A) Any electromagnetic radiation, other than ionizing electromagnetic radiation. (B) Any sonic, ultrasonic, or infrasonic wave.

(15) "Radiation generating equipment" means any manufactured product or device, or component part of such a product or device, or any machine or system that during operation can generate or emit radiation except those that emit radiation only from radioactive material.

(16) "Radioactive material" means material (solid, liquid, or gas) that emits ionizing radiation spontaneously. It includes accelerator produced, byproduct, naturally occurring, source, and special nuclear materials.

(17) "Source material mill tailings" means the tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from underground solution extraction processes, but not including underground ore bodies depleted by such solution extraction processes.

(18) "Source material milling" means any processing of ore, including underground solution extraction of unmined ore, primarily for the purpose of extracting or concentrating uranium or thorium that results in the production of source material mill tailings.

(19) "Specific license" means a license, issued to a named person upon application filed under the regulations promulgated under this chapter, to use, manufacture, produce, transfer, receive, acquire, or possess quantities of, or devices or equipment utilizing, radioactive material.

(20) "Spent nuclear fuel" means irradiated nuclear fuel that has undergone at least one (1) year's decay since being used as a source of energy in a power reactor. Spent fuel includes the special nuclear material, byproduct material, source material, and other radioactive material associated with fuel assemblies.

(21) "Transuranic waste" means radioactive waste containing alpha emitting transuranic elements, with radioactive half-lives greater than five (5) years, in excess of ten (10) nanocuries per gram.

290 IAC 3-1-4 Communications Sec. 4. (a) In accordance with IC 10-19-2.1-1 and except where specifically stated otherwise, all notifications, correspondence, communications, and reports, or oath and affirmation certifications required to be submitted under this Article shall be submitted electronically in writing and addressed to the Department at rmcp@dhs.in.gov.

6 Submissions made by paper shall be made out to:

Indiana Department of Homeland Security Radioactive Materials Control Program 302 W. Washington St. Room E208 Indianapolis, IN 46204 (b) In case of an emergency, or when an immediate or 24-hour notification is required, notification shall be made telephonically to (317) 233-6611.

290 IAC 3-1-5 Implementation Sec. 5. (a) On the date the State of Indiana becomes an agreement state as published in the Federal Register, a person who possesses a general or specific license issued by the NRC for source, byproduct, or special nuclear material in quantities not sufficient to form a critical mass, is deemed to possess a like license issued under this section. The license shall expire on the earlier of 90 days after receipt from the Department of a notice of expiration of the license, or the date of expiration specified in the NRC license.

290 IAC 3-1-6 Inspections Sec. 6. (a) Requirements regarding Inspections are as required by the materials incorporated by reference.

(b) This section does not limit the authority granted in IC 10-19-11-3.

290 IAC 3-1-7 Violation Sec. 7. Violations of this Article may be enforced pursuant to IC 10-19-12-15 and IC 10-19-12-18.

290 IAC 3-1-8 Records Sec. 8. (a) Unless, otherwise stated in this Article, requirements regarding records are as required by the material incorporated by reference. In addition, for the purpose of this Article, records shall be provided in the form of printed materials, or electronic records capable of producing legible, accurate, and complete records during the required retention period. It shall not be provided on microform. The licensee shall maintain adequate safeguards against tampering with and loss of records. Records such as letters, drawings and specification, must include all pertinent information such as stamps, initials, and signatures.

290 IAC 3-1-9 Reports Sec. 9. (a) Unless otherwise stated in this Article, requirements regarding reports of theft or loss of licensed material are as required by the materials incorporated by reference.

(b) The requirement in 10 CFR 20.2201(a)(1)(ii) and (b)(1) is modified from 30 to 15 days.

(c) Reports required by 10 CFR 20.2201 shall include, to the extent that the information is available at the time of notification, the following information:

(1) The name of the person making the report and their call-back telephone number; (2) Time and date of the event, and; (3) The exact location of the event, if available.

290 IAC 3-1-10 Vacating Premises Sec. 10. Each specific licensee shall, no less than thirty (30) days before vacating or relinquishing possession or control of premises which may have been contaminated with

7 radioactive material as a result of his or her activities, notify the Department in writing of intent to vacate. When deemed necessary by the Department, the licensee shall decontaminate the premises in such a manner as the Department may specify.

Rule 2.

Standards for Protection Against Radiation 290 IAC 3-2-1 Applicability Sec. 1 (a) This Article, except as otherwise specifically provided, applies to all persons who use, store, produce, transport, possess or dispose of radioactive materials within the state of Indiana.

(b) This Article does not apply to any person to the extent such a person is subject to regulation by the U.S. Nuclear Regulatory Commission (NRC).

(c) The requirements of this rule are in addition to, and not in substitution for, other requirements of this Article. Provisions of rules 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18 also apply.

290 IAC 3-2-2 Incorporated Material Sec. 2. (a) Except as provided in this rule and to the extent that the provisions are not inconsistent with this Article, 10 CFR Part 20 is incorporated by reference.

(b) The following requirements of 10 CFR Part 20 are not incorporated in this Article:

1. 20.1001
2. 20.1002
3. 20.1003 (Definitions of Byproduct material, Commission, Decommission, Department, Generally applicable environmental radiation standards, Government agency, Source material, and Special Nuclear Material)
4. 20.1007
5. 20.1008
6. 20.1009
7. 20.1205
8. 20.1404(b) reference to the Environmental Protection Agency
9. 20.1405(a)(2)
10. 20.1406(b)
11. 20.1905(g)
12. 20.2106(d)
13. 20.2109
14. 20.2110
15. 20.2203(c) and (d)
16. 20.2206(a)(1), (3), (4), (5), and (6)
17. 20.2401
18. 20.2402
19. Appendix D to 10 CFR Part 20
20. Appendix F to 10 CFR Part 20 Rule 3.

Notices, Instructions, and Reports to Workers; Inspections and Compliance Procedures 290 IAC 3-3-1 Applicability Sec. 1 (a) This Article, except as otherwise specifically provided, applies to all persons who use, store, produce, transport, possess or dispose of radioactive materials within the state of Indiana.

(b) This Article does not apply to any person to the extent such a person is subject to regulation by the U.S. Nuclear Regulatory Commission (NRC).

(c) The requirements of this rule are in addition to, and not in substitution for, other

8 requirements of this Article. Provisions of rules 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18 also apply.

290 IAC 3-3-2 Incorporated Material Sec. 2. (a) Except as provided in this rule and to the extent that the provisions are not inconsistent with this Article, 10 CFR Part 19 is incorporated by reference.

(b) The following requirements of 10 CFR Part 19 are not incorporated in this rule:

1. 19.1
2. 19.2
3. 19.5
4. 19.8
5. Any references to 10 CFR 52 in 19.11(a)
6. 19.11(b) and (e)
7. 19.14(a)
8. 19.18
9. 19.20
10. 19.30
11. 19.32
12. 19.40 Rule 4. Rules of General Applicability to Domestic Licensing of Byproduct Material 290 IAC 3-4-1 Applicability Sec. 1 (a) This Article, except as otherwise specifically provided, applies to all persons who use, store, produce, transport, possess or dispose of radioactive materials within the state of Indiana.

(b) This Article does not apply to any person to the extent such a person is subject to regulation by the U.S. Nuclear Regulatory Commission (NRC)

(c) The requirements of this rule are in addition to, and not in substitution for, other requirements of this Article. Provisions of rules 2, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18 also apply.

290 IAC 3-4-2 Incorporated Material Sec. 2. (a) Except as provided in this rule and to the extent that the provisions are not inconsistent with this Article, 10 CFR Part 30 are incorporated by reference.

(b) The following requirements of 10 CFR Part 30 are not incorporated in this rule:

1.

30.1 2.

30.3(b), (c), and (d)

3. 30.4 (Paragraph (2) of the definition of Commencement of Construction, and paragraph (9)(ii) of the definition of Construction, Byproduct material, Decommission, Government agency, Person, Production facility, Source material, Special nuclear material, and Utilization facility)
4. 30.6
5. 30.7
6. 30.8
7. 30.11(b) and (c)
8. 30.21(c)
9. 30.34(d), (e)(1) and (3), (k)
10. 30.41(b)(6)

9

11. 30.52
12. 30.55
13. 30.63
14. 30.64 Rule 5. General Domestic Licenses for Byproduct Material 290 IAC 3-5-1 Applicability Sec. 1 (a) This Article, except as otherwise specifically provided, applies to all persons who use, store, produce, transport, possess or dispose of radioactive materials within the state of Indiana.

(b) This Article does not apply to any person to the extent such a person is subject to regulation by the U.S. Nuclear Regulatory Commission (NRC).

(c) The requirements of this rule are in addition to, and not in substitution for, other requirements of this Article. Provisions of rules 2, 3, 4, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18 also apply.

290 IAC 3-5-2 Incorporated Material Sec. 2. (a) Except as provided in this rule and to the extent that the provisions are not inconsistent with this Article, 10 CFR Part 31 are incorporated by reference.

(b) The following requirements of 10 CFR Part 31 are not incorporated in this rule:

1. 31.1
2. 31.3
3. 31.4
4. 31.5(a) exclude Federal
5. 31.13
6. 31.14
7. 31.15
8. 31.16
9. 31.17
10. 31.18
11. 31.19
12. 31.20
13. 31.21
14. 31.22
15. 31.23 Rule 6. Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material 290 IAC 3-6-1 Applicability Sec. 1 (a) This Article, except as otherwise specifically provided, applies to all persons who use, store, produce, transport, possess or dispose of radioactive materials within the state of Indiana.

(b) This Article does not apply to any person to the extent such a person is subject to regulation by the U.S. Nuclear Regulatory Commission (NRC).

(c) The requirements of this rule are in addition to, and not in substitution for, other requirements of this Article. Provisions of rules 2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18 also apply.

290 IAC 3-6-2 Incorporated Material Sec. 2. (a) Except as provided in this rule and to the extent that the provisions are not

10 inconsistent with this Article, 10 CFR Part 32 are incorporated by reference.

(b) The following requirements of 10 CFR Part 32 are not incorporated in this rule:

1. 32.1
2. 32.3
3. 32.8
4. 32.11
5. 32.12
6. 32.14
7. 32.15
8. 32.16
9. 32.18
10. 32.19
11. 32.20
12. 32.21
13. 32.21a
14. 32.22
15. 32.23
16. 32.25
17. 32.26
18. 32.27
19. 32.28
20. 32.29
21. 32.30
22. 32.31
23. 32.32
24. 32.210(a)-(h)
25. 32.211
26. 32.301
27. 32.303 290 IAC 3-6-3 Requirements for License to Manufacture, Prepare, or Transfer for Commercial Distribution of Radioactive Drugs Containing Material for Medical Use Under Rule 13 Sec. 3. In addition to the provisions of 10 CFR §32.72(b)(4), an individual may function as an authorized nuclear pharmacist only if they are licensed as a pharmacist by the Indiana State Board of Pharmacy.

290 IAC 3-6-4 Registration of Product Information Sec. 4. The Department does not administer a sealed source and device registration program. Any manufacturer or initial distributor of a sealed source or device containing a sealed source who is subject to this Article shall submit a request for evaluation of radiation safety information about its product and for its registration to the Nuclear Regulatory Commission pursuant to 10 CFR §32.210.

Rule 7. Specific Domestic Licenses of Broad Scope for Byproduct Material 290 IAC 3-7-1 Applicability Sec. 1 (a) This Article, except as otherwise specifically provided, applies to all persons who use, store, produce, transport, possess or dispose of radioactive materials within the state of Indiana.

(b) This Article does not apply to any person to the extent such a person is subject to regulation by the U.S. Nuclear Regulatory Commission (NRC).

11 (c) The requirements of this rule are in addition to, and not in substitution for, other requirements of this Article. Provisions of rules 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18 also apply.

290 IAC 3-7-2 Incorporated Material Sec. 2. (a) Except as provided in this rule and to the extent that the provisions are not inconsistent with this Article, 10 CFR Part 33 are incorporated by reference.

(b) The following requirements of 10 CFR Part 33 are not incorporated in this rule:

1. 33.1
2. 33.8
3. 33.21
4. 33.23 Rule 8. Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations 290 IAC 3-8-1 Applicability Sec. 1. (a) This rule establishes radiation safety requirements for persons utilizing sources of radiation for industrial radiography operations.

(b) Except for industrial radiation machines regulated pursuant to I.C. 16-41-35, the requirements in this rule apply to all licensees or registrants who use sources of radiation for industrial radiography; provided, however, that nothing in this rule shall apply to the use of sources of radiation in the healing arts.

(c) The requirements of this rule are in addition to, and not in substitution for, other requirements of this Article. Provisions of rules 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18 also apply.

290 IAC 3-8-2 Incorporated Material Sec. 2. (a) Except as provided in this rule and to the extent that the provisions are not inconsistent with this Article, 10 CFR Part 34 is incorporated by reference.

(b) The following provisions of 10 CFR Part 34 are not incorporated in this rule:

1. 34.1
2. 34.8
3. 34.87
4. 34.121
5. 34.123 290 IAC 3-8-3 Reconciliation of differences Sec. 3. To reconcile differences between this rule and the incorporated sections of 10 CFR Part 34, the following words and phrases shall be substituted for the language in 10 CFR Part 34 as follows:

(1) Any reference to licensee shall be deemed to include registrant.

(2) Any reference to license shall be deemed to include registration.

(3) Any referenced to licensed shall be deemed to include registered.

Rule 9. Medical Use of Radioactive Material 290 IAC 3-9-1 Applicability Sec. 1 (a) This Article, except as otherwise specifically provided, applies to all persons who use, store, produce, transport, possess or dispose of radioactive materials within the state of Indiana.

12 (b) This Article does not apply to any person to the extent such a person is subject to regulation by the U.S. Nuclear Regulatory Commission (NRC).

(c) The requirements of this rule are in addition to, and not in substitution for, other requirements of this Article. Provisions of rules 2, 3, 4, 5, 6, 7, 8, 10, 11, 12, 13, 14, 15, 16, 17, and 18 also apply.

290 IAC 3-9-2 Incorporated Material Sec. 2. (a) Except as provided in this rule and to the extent that the provisions are not inconsistent with this Article, 10 CFR Part 35 is incorporated by reference.

(b) The following provisions of 10 CFR Part 35 are not incorporated in this rule:

1. 35.1
2. 35.8
3. 35.11(c)(1)
4. 35.13(a)(1)
5. 35.4001
6. 35.4002 290 IAC 3-9-3 Reports Sec. 3. (a) In addition to the requirements outlined in 10 CFR 35 Subpart M, the licensee shall notify the Department by telephone upon discovery, but no later than the next business day, that:

(1) A patient or human research subject has departed from the licensees facility without authorization under 10 CFR 35.75; or (2) A patient or human research subject containing radioactive material has died, and it is possible that any individual could receive an effective dose equivalent in excess of the dose limits set forth in 10 CFR 20.1301 as a result of the deceaseds body.

(b) In addition to the requirements outlined in 10 CFR 35 Subpart M, the licensee shall submit a written report to the Department within thirty (30) days after the discovery of an event listed in subsection (a) of this section. The written report must include:

(1) The licensees name; (2) The date and time of the unauthorized departure or date of death, as appropriate; (3) The date and time when patient release was expected to occurred, if applicable; (4) The address of the patients or human research subjects home or anticipated destination following unauthorized departure, if applicable; (5) The radionuclide, chemical and physical form, and calculated activity at the time of unauthorized departure or death; (6) The apparent reason(s) for the unauthorized departure or death prior to authorized released, if applicable; (7) The names (or titles) and address(es) of known individuals who might have received a TEDE exceeding five (5) mSv (one half (0.5) rem); and (8) A description of any changes in the licensees patient release criteria or patient instructions that are designed to avoid a recurrence of such an event.

Rule 10. Licenses and Radiation Safety Requirements for Irradiators 290 IAC 3-10-1 Applicability Sec. 1. (a) This rule establishes requirement for the issuance of a license authorizing radioactive materials in irradiators used to irradiate objects or material using gamma

13 radiation. This rule also establishes radiation safety requirements for operating irradiators.

(b) This rule applies to panoramic irradiators that have either dry or wet storage of the radioactive sealed sources and to under-water irradiators in which both the source and the product being irradiated are under water. Irradiators whose dose rate exceeds 5 grays (500 rads) per hour at 1 meter from the radioactive sealed sources in air or in water, as applicable for the irradiator type, are covered by this rule.

(c) The requirements set out in this rule do not apply to self-contained dry-source-storage irradiators (those in which both the source and the area subject to irradiation are contained within a device and are not accessible by personnel), medical radiology or teletherapy, radiography (the irradiation of materials for nondestructive testing purposes), gauging, or open-field (agricultural) irradiations.

(d) The requirements of this rule are in addition to, and not in substitution for, other requirements of this Article. Provisions of rules 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 17, and 18 also apply.

(e) Nothing in this Rule relieves the licensee from complying with other applicable federal, state, and local regulations governing the siting, zoning, land use, and building code requirements for industrial facilities.

290 IAC 3-10-2 Incorporated Material Sec. 2. (a) Except as provided in this rule and to the extent that the provisions are not inconsistent with this Article, 10 CFR Part 36 is incorporated by reference.

(b) The following provisions of 10 CFR Part 36 are not incorporated in this rule:

1. 36.1(a)
2. 36.2 (Paragraph (2) of the definition of Commencement of Construction and paragraph (9)(ii) of the definition Construction).
3. 36.8
4. 36.91
5. 36.93 290 IAC 3-10-3 Reconciliation of differences Sec. 3. To reconcile difference between this rule and the incorporated sections of 10 CFR Part 36, the following words and phrases shall be substituted for the language in 10 CFR Part 36 as follows:

(1) Any reference to licensee shall be deemed to include registrant.

(2) Any reference to license shall be deemed to include registration.

(3) Any reference to licensed shall be deemed to include registered.

Rule 11. Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material 290 IAC 3-11-1 Applicability Sec. 1 (a) This Article, except as otherwise specifically provided, applies to all persons who use, store, produce, transport, possess or dispose of radioactive materials within the state of Indiana.

(b) This Article does not apply to any person to the extent such a person is subject to regulation by the U.S. Nuclear Regulatory Commission (NRC).

(c) The requirements of this rule are in addition to, and not in substitution for, other requirements of this Article. Provisions of rules 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 13, 14, 15, 16, 17, and 18 also apply.

14 290 IAC 3-11-2 Incorporated Material Sec. 2. (a) Except as provided in this rule and to the extent that the provisions are not inconsistent with this Article, 10 CFR Part 37 is incorporated by reference.

(b) The following requirements of 10 CFR Part 37 are not incorporated in this rule:

1. 37.1
2. 37.3
3. 37.5 (definition of Byproduct material, Commission, Government Agency, Person)
4. 37.7
5. 37.13
6. 37.101
7. 37.107
8. 37.109 Rule 12. Licenses for Well Logging and Radiation Safety Requirements for Well Logging Operations 290 IAC 3-12-1 Applicability Sec. 1. (a) This rule prescribes requirements for the issuance of a license authorizing the use of sources of radiation in well logging in a single well. This rule also prescribes radiation safety requirements for persons using sources of radiation in these operations.

(b) This rule applies to all licensees who use sources of radiation for well logging operations including mineral logging, radioactive markers, or subsurface tracer studies.

(c) The requirements set out in this rule do not apply to the issuance of a license authorizing the use of sources of radiation in tracer studies involving multiple wells, such as field flooding studies, or to the use of sources of radiation auxiliary to well logging but not lowering into wells.

(d) The requirements of this rule are in addition to, and not in substitution for, other requirements of this Article. Provisions of rules 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 13, 14, 15, 16, 17, and 18 also apply.

290 IAC 3-12-2 Incorporated Material Sec. 2. (a) Except as provided in this rule and to the extent that the provisions are not inconsistent with this Article, 10 CFR Part 39 is incorporated by reference.

(b) The following provisions of 10 CFR Part 39 are not incorporated in this rule:

1. 39.1
2. 39.8
3. 39.101
4. 39.103 Rule 13. Domestic Licensing of Source Material 290 IAC 3-13-1 Applicability Sec. 1 (a) This Article, except as otherwise specifically provided, applies to all persons who use, store, produce, transport, possess or dispose of radioactive materials within the state of Indiana.

(b) This Article does not apply to any person to the extent such a person is subject to regulation by the U.S. Nuclear Regulatory Commission (NRC).

(c) The requirements of this rule are in addition to, and not in substitution for, other requirements of this Article. Provisions of rules 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, and 18 also apply.

15 290 IAC 3-13-2 Incorporated Material Sec. 2. (a) Except as provided in this rule and to the extent that the provisions are not inconsistent with this Article, 10 CFR Part 40 are incorporated by reference.

(b) The following requirements of 10 CFR Part 40 are not incorporated in this rule:

1. 40.1
2. 40.2
3. 40.2a
4. 40.4 (definition of Byproduct material, Reconciliation, paragraph (2) in the definition of Commencement of Construction, Commission, paragraph (9)(ii) in the definition of Construction, Decommission, "Foreign obligations, Government agency, Persons, Source material, and Special nuclear material only)
5. 40.5
6. 40.7
7. 40.8
8. 40.12(b)
9. 40.13(c)(5)(iv)
10. 40.20(b) and (c)
11. 40.22(a) exclude Federal
12. 40.23
13. 40.26
14. 40.27
15. 40.28
16. 40.31(g), (j)-(m)
17. 40.32(d) and (g), and any portion of (e) which applies to uranium enrichment

& uranium hexafluoride facilities.

18. 40.33
19. 40.35(f)
20. 40.38
21. 40.41(d), (e)(1) and (3), (g) and (h)
22. 40.51(b)(6)
23. 40.52
24. 40.53
25. 40.56
26. 40.64
27. 40.66
28. 40.67
29. 40.81
30. 40.82
31. Criterion 11A-F and 12 of Appendix A Rule 14. Licensing Requirements for Land Disposal of Radioactive Waste 290 IAC 3-14-1 Applicability Sec. 1 (a) This Article, except as otherwise specifically provided, applies to all persons who use, store, produce, transport, possess or dispose of radioactive materials within the state of Indiana.

(b) This Article does not apply to any person to the extent such a person is subject to regulation by the U.S. Nuclear Regulatory Commission (NRC).

(c) The requirements of this rule are in addition to, and not in substitution for, other requirements of this Article. Provisions of rules 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 15, 16, 17, and 18 also apply.

16 290 IAC 3-14-2 Incorporated Material Sec. 2. (a) Except as provided in this rule and to the extent that the provisions are not inconsistent with this Article, 10 CFR Part 61 are incorporated by reference.

(b) The following requirements of 10 CFR Part 61 are not incorporated in this rule:

1. 61.1
2. 61.2 definition of Commission, Government agency, and Person
3. 61.3
4. 61.4
5. 61.5
6. 61.6
7. 61.7
8. 61.8
9. 61.9
10. 61.9a
11. 61.9b
12. 61.10
13. 61.11
14. 61.12
15. 61.13
16. 61.14
17. 61.15
18. 61.16
19. 61.20
20. 61.21
21. 61.22
22. 61.23(a)-(l)
23. 61.24
24. 61.25
25. 61.26
26. 61.27
27. 61.28
28. 61.29
29. 61.30
30. 61.31
31. 61.32
32. 61.40
33. 61.41
34. 61.42
35. 61.43
36. 61.44
37. 61.50
38. 61.51
39. 61.52
40. 61.53
41. 61.54
42. 61.58
43. 61.59
44. 61.61
45. 61.62
46. 61.63
47. 61.70

17

48. 61.71
49. 61.72
50. 61.73
51. 61.80
52. 61.81
53. 61.82
54. 61.83
55. 61.84 Rule 15. Specific Domestic Licenses of Special Nuclear Material 290 IAC 3-15-1 Applicability Sec. 1 (a) This Article, except as otherwise specifically provided, applies to all persons who use, store, produce, transport, possess or dispose of radioactive materials within the state of Indiana.

(b) This Article does not apply to any person to the extent such a person is subject to regulation by the U.S. Nuclear Regulatory Commission (NRC).

(c) The requirements of this rule are in addition to, and not in substitution for, other requirements of this Article. Provisions of rules 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 17, and 18 also apply.

290 IAC 3-15-2 Incorporated Material Sec. 2. (a) Except as provided in this rule and to the extent that the provisions are not inconsistent with this Article, 10 CFR Part 70 are incorporated by reference.

(b) The following requirements of 10 CFR Part 70 are not incorporated in this rule:

1. 70.1
2. 70.2
3. 70.4 (paragraph (2) in the definition of Commencement of Construction, Commission, paragraph (9)(ii) in the definition of Construction, Decommission, Government agency, Person, Source material, and Special nuclear material)
4. 70.5
5. 70.7
6. 70.8
7. 70.13
8. 70.14
9. 70.20a
10. 70.20b
11. 70.21(a)(1), (c), (f), (g), & (h)
12. 70.22 (b), (c), (f)-(n)
13. 70.23(a)(1), (a)(6) through (a)(12) and (b)
14. 70.23a
15. 70.24
16. 70.25(a)(1), (c), (d), and (f)
17. 70.31(c), (d), and (e)
18. 70.32(a)(1), (4), (5), (6), and (7) and (b)(1), (3), and (4), and (c)-(k)
19. 70.37
20. 70.40
21. 70.42(b)(6)
22. 70.44
23. 70.51(c)
24. 70.52

18

25. 70.55(c)
26. 70.59
27. 70.60
28. 70.61
29. 70.62
30. 70.64
31. 70.65
32. 70.66
33. 70.72
34. 70.73
35. 70.74
36. 70.76
37. 70.82
38. 70.91
39. 70.92
40. Appendix A to Part 70 Rule 16. Packaging and Transportation of Radioactive Material 290 IAC 3-16-1 Applicability Sec. 1. (a) This rule establishes requirements for packaging, preparation for shipment, and transportation of licensed material.

(b) The packaging and transportation of licensed material are also subject to the requirements of other agencies (e.g., the U.S. Department of Transportation, the U.S.

Nuclear Regulatory Commission, and the U.S. Postal Service) having jurisdiction over means of transport.

(c) The requirements of this rule are in addition to, and not in substitution for, other requirements of this Article. Provisions of rules 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, and 18 also apply.

(d) This rule applies to any licensee authorized by specific or general license issued by the Department to receive, possess, use, or transfer licensed material, if the licensee delivers that material to a carrier for transport, transports the material outside the site of usage as specified in the Department license, or transports that material on public highways. No provision of this rule authorizes possession of licensed material.

290 IAC 3-16-2 Incorporated Material Sec. 2. (a) Except as provided in this rule and to the extent that the provisions are not inconsistent with this Article, 10 CFR Part 71 is incorporated by reference.

(b) The following provisions of 10 CFR Part 71 are not incorporated in this rule:

1. 71.0(a), (b), (d), (e), (f), and (g)
2. 71.1
2. 71.6
3. 71.9
4. 71.10
5. 71.11
6. 71.14(b)
7. 71.16
8. 71.18
9. 71.19
10. 71.24
11. 71.25
12. 71.31

19

13. 71.33
14. 71.35
15. 71.37
16. 71.38
17. 71.39
18. 71.41
19. 71.43
20. 71.45
21. 71.51
22. 71.53
23. 71.55
24. 71.57
25. 71.59
26. 71.61
27. 71.63
28. 71.64
29. 71.65
30. 71.70
31. 71.71
32. 71.73
33. 71.74
34. 71.75
35. 71.77
36. 71.85(a), (b), and (c)
37. 71.91(b)
38. 71.99
39. 71.100
40. 71.101 (c)(2), (d), and (e)
41. 71.107
42. 71.109
43. 71.111
44. 71.113
45. 71.115
46. 71.117
47. 71.119
48. 71.121
49. 71.123
50. 71.125 Rule 17. Exemptions and Continued Regulatory Authority in Agreement States and in Offshore Waters Under Section 274 290 IAC 3-17-1 Applicability Sec. 1 (a) This Article, except as otherwise specifically provided, applies to all persons who use, store, produce, transport, possess or dispose of radioactive materials within the state of Indiana.

(b) This Article does not apply to any person to the extent such a person is subject to regulation by the U.S. Nuclear Regulatory Commission (NRC).

(d) The requirements of this rule are in addition to, and not in substitution for, other requirements of this Article. Provisions of rules 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, and 18 also apply.

20 290 IAC 3-17-2 Incorporated Material Sec. 2. (a) Except as provided in this rule and to the extent that the provisions are not inconsistent with this Article, 10 CFR Part 150 are incorporated by reference.

(b) The following requirements of 10 CFR Part 150 are not incorporated in this rule:

1. 150.1
2. 150.2
3. 150.3 (Definitions of Byproduct material, Commission, Foreign obligations, Government Agency, Person, Production Facility, Reconciliation, Source material, Special Nuclear Material, and Utilization facility)
4. 150.4
5. 150.7
6. 150.8
7. 150.10
8. 150.14
9. 150.15
10. 150.15a
11. 150.16
12. 150.17
13. 150.17a
14. 150.19
15. 150.21
16. 150.30
17. 150.31
18. 150.32
19. 150.33 290 IAC 3-17-3 Medical Use Limitation Sec. 3. (a) The Department will not accept any applications for reciprocity under this rule with respect to activities authorized pursuant to regulations that are equivalent to Rule 13 of this Article entitled Medical Use of Radioactive Material. These activities will only be authorized under the provision of a specific license issued by the Department.

Rule 18. Fees 290 IAC 3-18-1 Applicability Sec. 1. (a) This section applies to any person who is an applicant for, or holder of, a radioactive materials license issued under 290 IAC Article 3 Standards for Protection Against Radiation.

290 IAC 3-18-2 Incorporated Material Sec. 2. (a) Except as provided in this rule and to the extent that the provisions are not inconsistent with this Article, 10 CFR Part 170 and 171 are incorporated by reference.

(b) The following provisions of 10 CFR Part 170 and 171 are not incorporated in this rule:

1. 170.1
2. 170.2
3. 170.3
4. 170.4 5 170.5
6. 170.8
7. 170.11(a)
8. 170.12(c)(1), (c)(3), and (d) through (f)

21

9. 170.21
10. 170.51
11. 171.1
12. 171.3
13. 171.5
14. 171.7
15. 171.8
16. 171.9
17. 171.11(b) and (d)
18. 171.13
19. 171.15
20. 171.16(a)(1)(v) and (a)(2)
21. 171.17(a)
22. 171.19
23. 171.23
24. 171.25
25. 171.26
26. In 10 CFR 170.31 and 171.16 the following categories of materials licenses and types of fees are also not incorporated: 1.A, 1.B, 1.E, 1.F, 2.A.(1), 2.A.(1)-

(2), 2.A.(4), 2.C, 3.D, 3.H, 4.A, 8, 9, 10, 11, 12, 13, 15, 17, and 18.

290 IAC 3-18-3 Radioactive Materials Fees Sec. 2. (a) Annual license fees for radioactive materials shall be those set forth in 10 CFR 170 and other radioactive materials fees as described in 10 CFR 171.

(1) No refund shall be made if a license is terminated or suspended.

(2) If, by amendment or otherwise, a license changes to another fee category, the fee for the new category will take effect on the anniversary date of the license.

(b) Fees shall be paid utilizing a method approved by the Department.

(c) An initial application for a license shall be accompanied by the appropriate fees set forth in 10 CFR 170. Thereafter, if the Department approves the license application, the Department shall issue an annual fee invoice in accordance with the appropriate fee schedule in 10 CFR Part 171 on a quarterly basis. Invoice quarter will be based on the month of license issuance. Invoices will be issued during the quarter prior. Fees shall be paid by the last day of the quarter as shown on the license fee invoice. This subdivision shall not apply to full cost recovery licenses.

(d) An application for reciprocal recognition of a license shall be accompanied by the fees set forth in 10 CFR 170 and 10 CFR 171.

(e) The Department shall not accept an initial application for a license or reciprocal recognition of a license prior to payment of the fees required by subsections (c) and (d) of this section.

(f) If a single license authorizes more than one activity (e.g. human use and irradiator activities), annual fees will be assessed for each fee category applicable to the license.

If a person holds more than one license, the total annual fee assessed will be the cumulative total of the annual fees applicable to each license held.

(g) Special provisions for calculating annual fees during the agreement state transition period.

(1) The annual fees for the NRC licenses that are transferred to the State of Indiana on the date the State of Indiana becomes an agreement state shall be invoiced during the next invoice quarter based on the month of license issuance.

22 (2) During the first year after the date the Department attains agreement state status, the annual fee for each NRC license transferred to the State of Indiana shall be prorated, based on the schedule of fees in 10 CFR 171, for the period from the date agreement state status is attained until the licenses next invoice quarter.

290 IAC 3-18-4 Eligibility for Waiver of Annual Fee Sec. 3. (a) Any broad-scope (academic or medical) licensee that provides in-kind services to the Department and/or performs services pursuant to an accepted written agreement with the Department, and which are valued at an equal or greater amount than their annual license fee, must submit a written request for a waiver from payment of the annual license fee. Upon approval by the Department, this waiver shall only remain in effect for the annual licensing period. A new waiver must be submitted for each subsequent annual licensing period.

(b) Any licensee which is a governmental agency of the State of Indiana must submit a written request for a waiver from payment of the annual license fee. Upon approval by the Department, this waiver shall remain in effect until the expiration of the license. A new waiver request must be submitted with each subsequent license renewal.

(c) Revocation of Annual Fee Waiver (1) Upon written notice of noncompliance to the licensee, the Department may revoke any waiver, approved pursuant to subsections (a) or (b) of this section, for failure to provide or perform all services pursuant to the accepted written agreement.

(2) The Department may also invoice the licensee for any difference between the originally waived annual fee and the value of services already performed during that annual licensing period.

290 IAC 3-18-5 Reciprocity Fees Sec. 4. (a) Each annual application to operate in Indiana under reciprocity shall be accompanied by the applicably fee listed in 10 CFR 170.31 Table 1. Reciprocity fees are non-refundable. There will be no pro-rating of reciprocity fees.

(b) A reciprocity application shall not be considered prior to payment of the full amount specified. Reciprocity applications for which no remittance is received shall be returned to the applicant.

(c) No additional reciprocity fees shall be required for the same category of activity during the remainder of that calendar year. All reciprocity authorizations shall expire on December 31 of the year in which the application was submitted. Any additional reciprocity activity beyond December 31 of that year shall require a new reciprocity application.

(d) Any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission or any Agreement State and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained and is applying for reciprocity for the sole purpose of providing federally sponsored radiation training, the licensee may request in writing that the required reciprocity fee be waived.

STATE REGULATION STATUS State: Indiana Tracking Ticket Number: 25-17 Date: April 7, 2025

[amendment(s) reviewed identified by a

  • at the beginning of the equivalent NRC requirement.]

RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 2023-1 Miscellaneous Corrections 10 CFR PARTS 1, 2, 26, 32, 40, 50, 51, 52, 72, and 73 09/25/2026

Ltr ML25049A263 OFFICE NMSS/MSST/SLPB NMSS/REFS/RRPB NMSS/MSST/SMPB NAME SFlaherty SSahle AGiantelli DATE Apr 2, 2025 Apr 2, 2025 Apr 7, 2025

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