September 18, 2013 

James L. McNees, CHP, Director 

Office of Radiation Control 

State Department of Public Health 

201 Monroe Street 

P.O. Box 303017 

Montgomery, AL 36130-3017 

Dear Mr. McNees: 

We have reviewed the June 19, 2013, letter sent by you in response to NRC comments on 

revised Alabama rules received by our office on June 25, 2013. These responses were 

reviewed by comparison to the equivalent U.S. Nuclear Regulatory Commission (NRC) rules in 

10 CFR Parts 19, 20, 30, 31, 32, 33, 35, 40, 61, 70 and 150 and the 24 comments on nine 

amendments identified in NRC letter dated July 19, 2012. We discussed our review of the 

regulations with David Walter on September 16, 2013. 

As a result of our review, we have retained 21 comments, amended 1 comment, and removed 2 

comments from our July 19, 2012, letter. Please note that we have limited our review to 

regulations required for compatibility and/or health and safety. The enclosed table shows the 22 

outstanding comments that need to be incorporated into Alabama’s final regulations along with 

our rationale to your responses. 

We request that when the regulations are revised and adopted as stated in the enclosed 

comment table, a copy of the “as published” regulations be provided to us for review. As 

requested in FSME Procedure SA-201, “Review of State Regulatory Requirements,” please 

highlight the final changes, and provide a copy to Division of Materials Safety and State 

Agreements, FSME. 

The SRS Data Sheet summarizes our knowledge of the status of other Alabama regulations, as 

indicated. Please let us know if you note any inaccuracies, or have any comments on the 

information contained in the SRS Data Sheet. This letter, including the SRS Data Sheet, is 

posted on the FSME website: http://nrc-stp.ornl.gov/rulemaking.html. 
J. McNees -2- 

If you have any questions regarding the comments, the compatibility and health and safety 

categories, or any of the NRC regulations used in the review, please contact Kathleen 

Schneider, State Regulation Review Coordinator, at (301) 415-2320 

(kathleen.schneider@nrc.gov) or Monica Ford at (610) 337-5214 (monica.orendi@nrc.gov). 

Sincerely, 

/RA D. White for/ 

Pamela J. Henderson, Deputy Director 

Division of Materials Safety and State Agreements 

Office of Federal and State Materials 

 and Environmental Management Programs 

Enclosures: 

1. Revised Compatibility 

 Comment Table 

2. Alabama SRS Data Sheet
J. McNees -2- 

If you have any questions regarding the comments, the compatibility and health and safety 

categories, or any of the NRC regulations used in the review, please contact Kathleen 

Schneider, State Regulation Review Coordinator, at (301) 415-2320 

(kathleen.schneider@nrc.gov) or Monica Ford at (610) 337-5214 (monica.orendi@nrc.gov). 

Sincerely, 

/RA D. White for/ 

Pamela J. Henderson, Deputy Director 

Division of Materials Safety and State Agreements 

Office of Federal and State Materials 

 and Environmental Management Programs 

Enclosures: 

1. Revised Compatibility 

 Comment Table 

2. Alabama SRS Data Sheet 

DISTRIBUTION: (SP05) 

DJanda, RI 

JKatanic, ASPB 

Incoming Document: ML13176A135 

OFFICE RI/RSAO ASPB OGC ASPB:BC MSSA:DD 

NAME MFord via 

email 

KSchneider BJones/jwo DWhite PHenderson/adw

DATE 08/02/13 08/06/13 09/12/13 09/18/13 09/18/13 

ML13213A296 OFFICIAL RECORD COPY Package ML13176A123 
1 

REVISED COMPATIBILITY COMMENTS ON ALABAMA FINAL REGULATIONS 

IN RESPONSE ALABAMA RESPONSE LETTER DATED JUNE 19, 2013 

STATE SECTION NRC 

SECTION 

RATS ID CATEGORY SUBJECT and COMMENTS 

1 420-3-26-

.02(10)(u) 

32.72 2006-1 

2007-1 2007-3 

B Manufacture, preparation, or transfer for commercial distribution of 

radioactive drugs, containing byproduct material for medical use under Part 35 Alabama (AL) does not have equivalent regulations corresponding to 10 CFR 32.72(a)(2)(iv), 32.72(a)(2)(v), 32.72(b)(3), 32.72(b)(4), 32.72(b)(5)(iii), or 32.72(b)(5)(v). AL needs to rewrite 420-3-26-.02(10)(u)1.(ii)(II) and (III) to read “(II) Registered or licensed with the Alabama Board of Pharmacy or another state agency as a drug manufacturer, (III) Licensed as a pharmacy by the Alabama Board of Pharmacy or another State Board of Pharmacy; [insert equivalent text to 10 CFR 32.72(a)(2)(iv)]. or [insert equivalent text to 10 CFR 32.72(a)(2)(v)].” AL needs to rewrite 420-3-26-.02(10)(u)1.(iv)(I) to say “...whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution ...” AL needs to insert their equivalent reference to 10 CFR 32.72(a)(2)(iv) in 420-3-26-.02(10)(u)2. AL needs to insert their equivalent reference to 10 CFR 32.72(b)(4) in 420-3-26-.02(10)(u)2.(i). AL needs to rewrite 420-3-26.02(1)(u)2.(ii) to read “... to work as an authorized nuclear pharmacist if: (I) This individual qualifies as an authorized nuclear pharmacist as defined in 420-3-26-.07(2); (II)This individual meets the requirements in 420-3-26-.07(28)(b) and 420-3-26-.07(30) and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist; or (III) This individual is designated as an 
2 

STATE SECTION NRC 

SECTION 

RATS ID CATEGORY SUBJECT and COMMENTS 

authorized nuclear pharmacist in accordance with paragraph [insert equivalent to 10 CFR 32.72(b)(4) once added] of this section.” AL needs to rewrite 420-3-26-.02(10)(u)2.(iii)(III) to read “The permit issued by an Agency, U.S. Nuclear Regulatory Commission, or Agreement State licensee or a Commission master materials permittee of broad scope or the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacists, or (IV) [insert equivalent to 10 CFR 32.72(b)(5)(v)], and (V) A copy of their license or registration to practice nuclear pharmacy by the Alabama Board of Pharmacy or other equivalent State Board of Pharmacy, no later than 30 days after the date that the licensee allows, under paragraphs [insert equivalent for 10 CFR 32.72(b)(2)(i) and (b)(2)(iii)] of this section, the individual to work as an authorized nuclear pharmacist.” AL needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 32.72. Comment from letters dated July 14, 2010, and July 19, 2012, has been amended. AL states in their June 19, 2013, letter, in item 1, that the AL Board of Pharmacy is the only state Agency that licenses drug manufacturers and pharmacies in AL. However, AL adopts an equivalent provision to 10 CFR 32.72(a)(2)(i) which allows a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug to be registered with the U.S. Food and Drug Administration. Since AL adopts an equivalent provision to 32.72(a)(2)(i) they should also adopt an equivalent provision to 10 CFR 32.72(a)(2)(iv). Adoption of equivalent text to 10 CFR 32.72(a)(2)(iv) does not prohibit the Pharmacy from first being licensed with the AL Board of Pharmacy before obtaining an AL radiopharmacy license. AL states in their June 19, 2013, letter, in item 1, that 10 CFR 32.72(a)(2)(v) is covered by their equivalent to 10 CFR 32.72(a)(2)(ii) and (iii) since they use 
3 

STATE SECTION NRC 

SECTION 

RATS ID CATEGORY SUBJECT and COMMENTS 

the word radioactive material in the opening paragraph instead of the word byproduct material. This clarification allows for the removal of needing equivalent text to 10 CFR 32.72(a)(2)(v) from the original comment. AL’s response in their letter dated June 19, 2013, item 1, to needing equivalent text to 10 CFR 32.72(b)(3) addresses needing equivalent text to 10 CFR 32.72(b)(4) regarding designating a pharmacist as an authorized nuclear pharmacist instead of adding language that, as stated in 10 CFR 32.72(b)(3), “The actions authorized in paragraphs (b)(1) and (b)(2) [change to AL equivalent] of this section are permitted in spite of more restrictive license conditions.” AL needs to add equivalent text to 10 CFR 32.72(b)(3) to their regulations. AL’s response in their letter dated June 19, 2013, item 1, states that they do not allow reciprocal recognition to practice pharmacy, but will allow the pharmacist to submit documentation that they are already licensed to practice pharmacy in another state as evidence that they do not have to take the written AL Pharmacy Board test. However, the individual cannot practice pharmacy in AL until after the AL Board of Pharmacy has issued them a license. By adopting essentially identical rule language to 10 CFR 32.72(b)(4) this does not prohibit AL from requiring that the individual first be licensed with the AL Board of Pharmacy. If AL chooses not to incorporate essentially identical text based on the response stating that AL does not allow licensees to “designate” individuals as authorized nuclear pharmacists then AL’s regulation will be more restrictive that NRC’s regulation and will not meet the definition of a Compatibility Category B. AL needs to adopt equivalent language to 10 CFR 32.72(b)(4). AL’s response in their letter dated June 19, 2013, item 1, states that with regards to 10 CFR 32.72(b)(5)(v), AL’s "definition of “radioactive material” has always included accelerator produced radioactive material and therefore we feel we should not add language that could be interpreted to mean that we did not license such material prior to the Energy Policy Act of 2005 (EPAct).” However, AL adopting equivalent language to 10 CFR 
4 

STATE SECTION NRC 

SECTION 

RATS ID CATEGORY SUBJECT and COMMENTS 

32.72(b)(5)(v) does not convey that AL did not have authority for accelerator produced radioactive material before the EPAct. It simply allows for an AL licensee to submit an individual, who worked in NRC/Federal jurisdiction prior to the dates mentioned in 10 CFR 32.72 (b)(5)(v), to be added to their license as an authorized nuclear pharmacist by AL, without having to provide a license with that individuals name on it or training requirements since NRC did not have authority over accelerator produced radioactive material prior to the dates listed in 10 CFR 32.72(b)(5)(v), so long as the licensee can provide documentation that only accelerator produced radioactive material was used in the practice of nuclear pharmacy at an NRC regulated facility. 

2 420-3-26-.07 

(2)(d) 

35.2 2006-1 B Definition: Authorized Medical Physicist 

AL omits the equivalent to paragraphs (ii) and (iv) of the 10 CFR 35.2 definition of Authorized medical physicist from their definition in 420-3-26-.07(2)(d). AL needs to remove the “and” after 420-3-26-.07(2)(d)(2)(ii) and change it to an “or.” AL needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 35.2 Definition: Authorized Medical Physicist. Comment stands from letter dated July 19, 2012. In letter dated June 19, 2013, item 15, AL agrees to address the first paragraph and challenges the second paragraph of this comment. AL states in their June 19, 2013, letter, in item 15, an authorized medical physicist is not allowed to perform licensed activities until such time as the Agency has reviewed their training and experience and issued an amended license that indicates by name, that they are an authorized medical physicist. This makes AL’s regulation more restrictive than NRC’s regulation since 10 CFR 35.2 allows for authorized medical physicists already approved on a license to use that license to be placed on another 
5 

STATE SECTION NRC 

SECTION 

RATS ID CATEGORY SUBJECT and COMMENTS 

license without having to resubmit their training and experience requirements. 10 CFR 35.2 Definition: Authorized Medical Physicist is a Compatibility Category B which means that an Agreement State’s regulation needs to be essentially identical to NRC’s rule and cannot be more restrictive. Since AL’s regulation is more restrictive, it does not meet the Compatibility Category B designation assigned to 10 CFR 35.2 Definition: Authorized Medical Physicist.

3 420-3-26-.07 

(2)(e) 

35.2 2006-1 B Definition: Authorized Nuclear Pharmacist 

AL omits the equivalent to paragraphs (ii) and (iv) of the 10 CFR 35.2 definition of Authorized nuclear pharmacist from their definition in 420-3-26-.07(2)(e). AL needs to remove the “and” after 420-3-26-.07(2)(e)(2)(ii) and (2)(e)(3) and change both to an “or.” AL needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 35.2 Definition: Authorized Nuclear Pharmacist. Comment stands from letter dated July 19, 2012. In letter dated June 19, 2013, item 16, AL stated they would not address this during their next rule revision. AL states in their June 19, 2013, letter, in item 16, becoming an authorized and licensed nuclear pharmacist requires approval by two agencies, the AL Board of Pharmacy and the AL Office of Radiation Control. AL states that adoption of 10 CFR 35.2 Definition: Authorized Nuclear Pharmacist paragraphs (ii) and (iv) will cause conflict with another Agency’s requirements. However, adding equivalent text to 420-3-26-.07(2)(e) that covers 10 CFR 35.2 Definition: Authorized Nuclear Pharmacist paragraph’s (ii) and (iv) does not prohibit or bypass AL’s requirement that before an 
6 

STATE SECTION NRC 

SECTION 

RATS ID CATEGORY SUBJECT and COMMENTS 

individual can perform duties as an authorized nuclear pharmacist they must first be licensed by both the AL Board of Pharmacy and the AL Office of Radiation Control. In not accepting training and experience requirements reviewed by another Agreement State or the NRC (as evidence by being listed on a license) during the process of adding an individual to a license as an authorized nuclear pharmacist, AL’s regulation is more restrictive than NRC’s regulation since 10 CFR 35.2 allows for authorized nuclear pharmacists already approved on a license to use that license to be placed on another license without having to resubmit their training and experience requirements. 10 CFR 35.2 Definition: Authorized Nuclear Pharmacist is a Compatibility Category B which means that an Agreement State’s regulation needs to be essentially identical to NRC’s rule and cannot be more restrictive. Since AL’s regulation is more restrictive, it does not meet the Compatibility Category B designation assigned to 10 CFR 35.2 Definition: Authorized Nuclear Pharmacist.

4 420-3-26-.07 

(2)(f) 

35.2 2006-1 B Definition: Authorized User 

AL omits the equivalent to paragraphs (ii) and (iv) of the 10 CFR 35.2 Definition of Authorized user from their definition in 420-3-26-.07(2)(f). AL needs to remove the “and” after 420-3-26-.07(2)(f)(2)(ii) and change it to an “or.” AL needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 35.2 Definition: Authorized User. Comment stands from letter dated July 19, 2012. In letter dated June 19, 2013, item 17, AL stated they would address this during their next rule revision. AL states in their June 19, 2013, letter, in item 17, an authorized user is not 
7 

STATE SECTION NRC 

SECTION 

RATS ID CATEGORY SUBJECT and COMMENTS 

allowed to perform licensed activities until such time as the Agency has reviewed their training and experience and issued an amended license that indicates by name, that they are an authorized user. This makes AL’s regulation more restrictive than NRC’s regulation since 10 CFR 35.2 allows for authorized users already approved on a license to use that license to be placed on another license without having to resubmit their training and experience requirements. 10 CFR 35.2 Definition: Authorized User is a Compatibility Category B which means that an Agreement State’s regulation needs to be essentially identical to NRC’s rule and cannot be more restrictive. Since AL’s regulation is more restrictive, it does not meet the Compatibility Category B designation assigned to 10 CFR 35.2 Definition: Authorized User.

5 420-3-26-.07 

(2)(gg) 

35.2 2006-1 B Definition: Radiation Safety Officer 

AL states in their definition of Radiation Safety Officer in 420-3-26-.07(2)(gg) “means an individual who meets the requirements in 420-3-26-.07(26) and 420-3-26-.07(30), and is named...” AL needs to change this to state “means an individual who meets the requirements in 420-3-26-.07(26) and 420-3-26-.07(30), or is named...” AL omits Commission or Agreement State license from their definition of Radiation Safety Officer in 420-3-26-.07(2)(gg). AL omits an equivalent to paragraph (ii) of the 10 CFR 35.2 definition of Radiation Safety Officer. AL needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 35.2 Definition: Radiation Safety Officer. Comment stands from letter dated July 19, 2012. In letter dated June 19, 2013, item 18, AL stated they would address this during their next rule revision. 
8 

STATE SECTION NRC 

SECTION 

RATS ID CATEGORY SUBJECT and COMMENTS 

AL states in their June 19, 2013, letter, in item 18, an individual is not an Radiation Safety Officer (RSO) on an agency license until an amended license is issued and a licensee is required to name an RSO on their license and the Agency must review their training and experience and issue an amended license that indicates by name the individual as RSO. This makes AL’s regulation more restrictive than NRC’s regulation since 10 CFR 35.2 allows for RSO’s already approved on a license to use that license to be placed on another license without having to resubmit their training and experience requirements. 10 CFR 35.2 Definition: Radiation Safety Officer is a Compatibility Category B which means that an Agreement State’s regulation needs to be essentially identical to NRC’s rule and cannot be more restrictive. Since AL’s regulation is more restrictive, it does not meet the Compatibility Category B designation assigned to 10 CFR 35.2 Definition: Radiation Safety Officer.

6 426-3-26-.07 

(26) 

35.50 2006-1 

2009-1 

B Training for Radiation Safety Officer 

AL states in 426-3-26-.07(26)(d) “Has obtained written certification, signed by ...” AL needs to change this to state “Has obtained written attestation, signed by ...” AL needs to make the above change in order to meet the Compatibility Category B designation assigned to 10 CFR 35.50. Comment stands from letter dated July 19, 2012. In letter dated June 19, 2013, item 19, AL stated they would address this during their next rule revision.

7 420-3-26-

.07(52) 

35.300 2006-1 

2007-3 

H&S Use of unsealed byproduct material for which a written directive is required 

AL needs to add “or equivalent NRC or Agreement State requirements” to 420-3-26-.07(52)(a) between “420-3-26-.02” and “or.” 
9 

STATE SECTION NRC 

SECTION 

RATS ID CATEGORY SUBJECT and COMMENTS 

AL needs to make the above change in order to meet the Compatibility Category H&S designation assigned to 10 CFR 35.300(a) and (b). Comment stands from letter dated July 14, 2010, and July 19, 2012. In letter dated June 19, 2013, item 14, AL stated they would address this during their next rule revision. 

8 420-3-26-.02 

(10)(f) 

32.201 2006-2 B Serialization of nationally tracked sources 

AL needs to replace “(insert effective date of rule)” with “September 1, 2012,” the actual effective date of the rule. AL needs to make the above change in order to meet the Compatibility Category B designation assigned to 10 CFR 32.201. Comment stands from letter dated July 19, 2012. In letter dated June 19, 2013, item 20, AL stated they would address this during their next rule revision. 

9 420-3-26-.02 

(4)(a) 

30.14 2007-2 B Exempt Concentrations 

AL omits a reference in 420-3-26-.02(4)(a)1. The first sentence should read “Except as provided in paragraphs (a)2 and (3) below, ...” AL omits an equivalent to 10 CFR 30.14(b). AL needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 30.14. Comment stands from letter dated July 19, 2012. In letter dated June 19, 2013, item 21, AL stated they would address this during their next rule revision. Note: AL copied half of Comment 10 from the July 19, 2012, letter into Item 
10 

STATE SECTION NRC 

SECTION 

RATS ID CATEGORY SUBJECT and COMMENTS 

21 in their June 19, 2013. However, their response is that AL will revise its rules to be compatible with 10 CFR 30.14 so it is understood that item 21 in the June 19, 2013, letter was meant to address comment 9 from NRC’s July 19, 2012, letter. 

10 420-3-26-.02 

(4)(b) 

30.15 2007-2 

2007-3 

B Certain items containing byproduct material 

AL omits the phrase “or persons who initially transfer for sale or distribution the following products containing tritium, promethium 147 or radium 226” after “products” and before “any person is exempt...” in 420-3-26-.02(4)(b). AL omits the wording “manufactured prior to November 30, 2007” from 420-3-26-.02(4)(b)1.(viii). AL omits the wording “manufactured prior to December 17, 2007” from 420-3-26-.02(4)(b)2. and (b)3. AL omits equivalent requirements to 10 CFR 30.15(b) from their regulations. AL needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 30.15. Comment stands from letter dated July 14, 2010, and July 19, 2012. In letter dated June 19, 2013, item 22, AL stated they would address this during their next rule revision. 

11 420-3-26-

.02-(10)(j) 

32.11 2007-2 NRC Introduction of byproduct material in exempt concentrations into products 

or materials, and transfer of ownership or possession: Requirements for license AL needs to remove 420-3-26-.02(10)(j)1. and 2. from its regulations. AL needs to make the above change in order to meet the Compatibility Category NRC designation assigned to 10 CFR 32.11. 
11 

STATE SECTION NRC 

SECTION 

RATS ID CATEGORY SUBJECT and COMMENTS 

Comment stands from letter dated July 14, 2010, and July 19, 2012. In letter dated June 19, 2013, item 3, AL stated they would address this during their next rule revision. 

12 420-3-26-

.02(10)(j)3. 

32.12 2007-2 NRC Same: Records and material transfer reports 

AL needs to remove 420-3-26-.02(10)(j)3. from its regulations. AL needs to make the above change in order to meet the Compatibility Category NRC designation assigned to 10 CFR 32.12. Comment stands from letter dated July 14, 2010, and July 19, 2012. In letter dated June 19, 2013, item 3, AL stated they would address this during their next rule revision. 

13 420-3-26-

.02(4)(a)2. 

32.13 2007-2 C Same: Prohibition of introduction 

AL needs to remove “pursuant to 420-326-.02(10)(i) or the general license provided in 420-3-26-.02(6) or (7) of this Rule 420-3-26-.02.” and replace it with “except in accordance with a license issued under 10 CFR 32.11.” AL needs to make the above change in order to meet the Compatibility Category C designation assigned to 10 CFR 32.13. Comment stands from letter dated July 14, 2010, and July 19, 2012. In letter dated June 19, 2013, item 4, AL stated they would address this during their next rule revision. 

14 420-3-26-

.03(33) 

20.2001 2007-3 C General requirements 

AL omits the reference to their regulation corresponding to 10 CFR 20.2008 from 420-3-26-.03(33)(a)4. 
12 

STATE SECTION NRC 

SECTION 

RATS ID CATEGORY SUBJECT and COMMENTS 

AL needs to add the above reference to 420-3-26-.03(33) in order to meet the Compatibility Category C designation assigned to 10 CFR 20.2001. Comment stands from letter dated July 14, 2010, and July 19, 2012. In letter dated June 19, 2013, item 6, AL stated they would address this during their next rule revision. 

15 420-3-26-

.03(38)

20.2006(e) 2007-3 B Transfer for disposal and manifests

AL does not have a regulation corresponding to 10 CFR 20.2006(e).AL needs to add the above regulation in order to meet the Compatibility Category B designation assigned to 10 CFR 20.2006(e).Comment rescinded. See AL Regulation 420-3-26-.03(38)(b), ML12131A532 and item 5 in AL response letter dated June 19, 2013. 

16 N/A 20.2008 2007-3 B Disposal of 11e.(3) and 11e.(4) byproduct material 

AL does not have a regulation corresponding to 10 CFR 20.2008. AL needs to add the above regulation in order to meet the Compatibility Category C designation assigned to 10 CFR 20.2001. Comment stands from letter dated July 14, 2010, and July 19, 2012. In letter dated June 19, 2013, item 7, AL stated they would address this during their next rule revision. 
13 

STATE SECTION NRC 

SECTION 

RATS ID CATEGORY SUBJECT and COMMENTS 

17 420-3-26-

.02(4)(e)2. 

30.18(b) 2007-3 B Exempt quantities 

AL needs to add “before September 25, 1971” between “acquired” and “under” in 420-3-26.02(4)(e)2. AL needs to make the above change in order to meet the Compatibility Category B designation assigned to 10 CFR 30.18(b). Comment stands from letter dated July 14, 2010, and July 19, 2012. In letter dated June 19, 2013, item 8, AL stated they would address this during their next rule revision. 

18 420-3-26-

.02(4)(c) 

30.20(a) 2007-3 B Gas and aerosol detectors containing byproduct material 

AL needs to replace “or” before “produce” with a “,” and add “or initially transfer for sale or distribution” between “produce” and “gas and aerosol detectors...” Also, the phrase “life of property” should read “life or property.” AL needs to add the word “initially” before the word transferred in 420-3-26-.02(4)(c)(1) and (2). AL needs to add the word “initial” before the word “transfer” in 420-3-26-.02(4)(c)(1) and (2). AL needs to add the following requirement to this section: “before November 30, 2007” in between “or transferred” and “in accordance” in 420-3-26-.02(4)(c)(2). AL needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 30.20. Comment stands from letter dated July 14, 2010, and July 19, 2012. In letter dated June 19, 2013, item 9, AL stated they would address this during their next rule revision. 
14 

STATE SECTION NRC 

SECTION 

RATS ID CATEGORY SUBJECT and COMMENTS 

19 420-3-26-

.02(8)(g) 

30.32(g) 2007-3 C Application for specific licenses 

AL does not have a regulation corresponding to 10 CFR 30.32(g)(3). AL needs to add the above regulation in order to meet the Compatibility Category C designation assigned to 10 CFR 30.32(g). Comment stands from letter dated July 14, 2010, and July 19, 2012. In letter dated June 19, 2013, item 10, AL stated they would address this during their next rule revision. 

20 N/A 30.34(g) 2007-3 H&S Terms and conditions of licenses 

AL does not have a regulation corresponding to 10 CFR 30.34(g). AL needs to add the above regulation in order to meet the Compatibility Category H&S designation assigned to 10 CFR 30.34(g). Comment stands from letter dated July 14, 2010, and July 19, 2012. In letter dated June 19, 2013, item 11, AL stated they would address this during their next rule revision. 
15 

STATE SECTION NRC 

SECTION 

RATS ID CATEGORY SUBJECT and COMMENTS 

21 420-3-26-

.02(7)(c) 

31.12 2007-3 C General license for certain items and self-luminous products containing 

radium-226 AL needs to replace “(entry effective date of rule)” with “September 1, 2012,” the actual effective date of the rule in 420-3-26-.02(7)(c)1. AL needs to make the above change in order to meet the Compatibility Category C designation assigned to 10 CFR 31.12. Comment stands from letter dated July 19, 2012. In letter dated June 19, 2013, item 23, AL stated they would address this during their next rule revision.

22 420-3-26-

.02(7)(e)4. 

32.58 2007-3 B Same: labeling of devices 

AL needs to replace the word “Importer” in 420-3-26-.02(7)(e)4(ii) with the phrase “initial transferor.” AL needs to make the above change in order to meet the Compatibility Category B designation assigned to 10 CFR 32.58. Comment stands from letter dated July 19, 2012. In letter dated June 19, 2013, item 24, AL stated they would address this during their next rule revision.

23 N/A 32.102 2007-3 B Schedule-C Prototype tests for Calibration or reference sources containing 

americium-241AL does not have a regulation corresponding to 10 CFR 32.102.AL needs to add the above regulation in order to meet the Compatibility Category B designation assigned to 10 CFR 32.102.
16 

STATE SECTION NRC 

SECTION 

RATS ID CATEGORY SUBJECT and COMMENTS 

Comment has been removed from the response letter. Although the comment was correct as written in 2012, a subsequent rulemaking (RATS ID 2012-4) removed 10 CFR 32.102 from NRC’s regulations, therefore Alabama no longer needs to adopt an equivalent section to NRC’s 10 CFR 32.102 as stated in our July 19, 2012, letter and their June 19, 2013, letter in item 13. 

24 420-3-26-.07 

(29) 

35.57 2009-1 B Training for experienced Radiation Safety Officer, teletherapy or medical 

physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. AL omits “on a U.S. Nuclear Regulatory Commission or Agreement State” with Agency license or permit in 420-3-26-.07(29)(a) & (b). AL needs to make the above change in order to meet the Compatibility Category B designation assigned to 10 CFR 35.57. Comment stands from letter dated July 19, 2012. AL states in their June 19, 2013 letter, in item 25, that “the Agency does not, and has not, allowed individuals listed on an NRC or Agreement State license to be “designated” as authorized users, nuclear pharmacists, medical physicists, or RSO’s, nor do we allow an authorized user, nuclear pharmacist, medical physicist, or RSO that is not already listed, by name, on an Agency license, to perform licensed duties.” This makes AL’s regulation more restrictive that NRC’s regulation. 10 CFR 35.57 is a Compatibility Category B which means that an Agreement State’s regulation needs to be essentially identical to NRC’s rule and cannot be more restrictive. Since AL’s regulation is more restrictive, it does not meet the Compatibility Category B designation assigned to 10 CFR 35.57. 
STATE REGULATION STATUS

State: Alabama 

 Tracking Ticket Number: 13-26 

[9 amendment(s) reviewed is identified by a * Date: September 18, 2013 at the beginning of the equivalent NRC requirement.] 

RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package Outgoing 

Package 

Notes 

1991-1 Safety Requirements for Radiographic Equipment 

Part 34 55 FR 843 (Superceded by 1997-5) 

01/10/1994 Final No Comments 

04/02/1994 

Alabama has adopted Final Regulations equivalent to RATS ID 1997-5 

1991-2 ASNT Certification of Radiographers 

Part 34 56 FR 11504 (Superceded by 1997-5) 

none Not Required Not Required Alabama has adopted Final 

Regulations equivalent to RATS ID 1997-5 

1991-3 Standards for Protection Against Radiation 

Part 20 56 FR 23360; 56 FR 61352; 57 FR 38588; 57 FR 57877; 58 FR 67657; 59 FR 41641; 60 FR 20183; 

01/01/1994 Final No Comments 

11/19/1997 

1991-4 Notification of Incidents 

Parts 20, 30, 31, 34, 39, 40, 70 56 FR 64980 

10/15/1994 Final No Comments 

 04/02/1994 

1992-1 Quality Management Program and 

Misadministrations Part 35 56 FR 34104 (Superceded by 2002-2)

01/27/1995 Final No Comments 

04/02/1994 

Alabama has adopted Final Regulations equivalent to RATS ID 2002-2 

1992-2 Eliminating the Recordkeeping Requirements 

for Departures from Manufacturer's Instructions Parts 30, 35 57 FR 45566 

none Not Required Not Required These regulation changes are not 

required to be adopted for purposes of Compatibility 

1993-1 Decommissioning Recordkeeping and License 

Termination: Documentation Additions [Restricted areas and spill sites] Parts 30, 40 58 FR 39628 

10/25/1996 Final No Comments 

06/05/1998 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package Outgoing 

Package 

Notes 

1993-2 Licensing and Radiation Safety Requirements for 

Irradiators Part 36 58 FR 7715 

07/01/1996 Final No Comments 

06/05/1998 

1993-3 Definition of Land Disposal and Waste Site QA 

Program Part 61 58 FR 33886 

07/22/1996 Not Applicable1 Not Applicable Alabama does not have any 

licensees subject to these regulations. (See SECY-95-112) 

1994-1 Self-Guarantee as an Additional Financial 

Mechanism Parts 30, 40, 70 58 FR 68726; 59 FR 1618 

none Final No Comments 

06/05/1998 

These regulation changes are not required to be adopted for purposes of Compatibility. 

1994-2 Uranium Mill Tailings Regulations: Conforming 

NRC Requirements to EPA Standards Part 40 59 FR 28220 

07/01/1997 Not Applicable Not Applicable Alabama does not have authority to 

regulate this material under its Agreement 

1994-3 Timeliness in Decommissioning Material Facilities 

Parts 30, 40, 70 59 FR 36026 

08/15/1997 Final No Comments 

06/05/1998 

1995-1 Preparation, Transfer for Commercial Distribution, 

and Use of Byproduct Material for Medical Use Parts 30, 32, 35 59 FR 61767; 59 FR 65243; 60 FR 322 

01/01/1998 Final No Comments 

06/05/1998 

1995-2 Frequency of Medical Examinations for Use of 

Respiratory Protection Equipment Part 20 60 FR 7900 

03/13/1998 Final No Comments 

06/05/1998 

1995-3 Low-Level Waste Shipment Manifest Information 

and Reporting Parts 20, 61 60 FR 15649; 60 FR 25983 

03/01/1998 Final No Comments 

06/05/1998 

1995-4 Performance Requirements for Radiography 

Equipment 

06/30/1998 Not Required Not required Alabama has adopted Final 

Regulations equivalent to RATS ID 1997-5 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package Outgoing 

Package 

Notes 

Part 34 60 FR 28323 (Superceded by 1997-5) 

1995-5 Radiation Protection Requirements: Amended 

Definitions and Criteria Parts 19, 20 60 FR 36038 

08/14/1998 Final No Comments 

06/05/1998 

1995-6 Clarification of Decommissioning Funding 

Requirements Parts 30, 40, 70 60 FR 38235 

11/24/1998 Final No Comments 

06/05/1998 

1995-7 Medical Administration of Radiation and Radioactive 

Materials Parts 20, 35 60 FR 48623 (Superceded by 2002-2 and 2005-2) 

10/20/1998 Final No Comments 

08/29/2000 

Alabama has adopted Final Regulations equivalent to RATS IDs 2002-2 and 2005-2 

1996-1 Compatibility with the International Atomic Energy 

Agency Part 71 60 FR 50248; 61 FR 28724 (Superceded by 2004-1) 

04/01/1999 Final No Comments 

08/29/2000 

Alabama has not yet adopted RATS 

ID 2004-1 in final. 

1996-2 One Time Extension of Certain Byproduct, Source 

and Special Nuclear Materials Licenses Parts 30, 40, 70 61 FR 1109 

02/15/1999 Not Required Not Required These regulation changes are not 

required to be adopted for purposes of Compatibility 

1996-3 Termination or Transfer of Licensed Activities: 

Record keeping Requirements Parts 20, 30, 40, 61, 70 61 FR 24669 

06/17/1999 Final No Comments 

08/29/2000 

1997-1 Resolution of Dual Regulation of Airborne Effluents 

of Radioactive Materials; Clean Air Act Part 20 61 FR 65120 

01/9/2000 Final No Comments 08/29/2000 

1997-2 Recognition of Agreement State Licenses in Areas 02/27/2000 Final No Comments 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package Outgoing 

Package 

Notes 

Under Exclusive Federal Jurisdiction Within an Agreement State Part 150 62 FR 1662 

08/29/2000 

1997-3 Criteria for the Release of Individuals Administered 

Radioactive Material Parts 20, 35 62 FR 4120 

05/29/2000 Final No Comments 

08/29/2000 

1997-4 Fissile Material Shipments and Exemptions 

Part 71 62 FR 5907 (Superceded by 2004-1) 

02/10/2000 Not Required Not Required These regulation changes are not 

required to be adopted for purposes of Compatibility. (See STP-97-078) 

1997-5 Licenses for Industrial Radiography and Radiation 

Safety Requirements for Industrial Radiography Operations Parts 30, 34, 71, 150 62 FR 28947 

06/27/2000 Final No Comments 

08/29/2000 

1997-6 Radiological Criteria for License Termination 

Parts 20, 30, 40, 70 62 FR 39057 

08/20/2000 Final No Comments 

08/29/2000 

1997-7 Exempt Distribution of a Radioactive Drug 

Containing One Micro curie of Carbon-14 Urea Part 30 62 FR 63634 

01/02/2001 Final No Comments 

06/05/1998 

1998-1 Deliberate Misconduct by Unlicensed Persons 

Parts 30, 40, 61, 70, 71, 150 

63 FR 1890; 63 FR 13773

02/12/2001 Final No Comments 

10/01/2001 

1998-2 Self-Guarantee of Decommissioning Funding by 

Nonprofit and Non-Bond-Issuing Licensees Parts 30, 40, 70 63 FR 29535 

07/01/2001 Not Required Not Required These regulation changes are not 

required to be adopted for purposes of Compatibility 

1998-3 License Term for Medical Use Licenses 

Part 35 63 FR 31604 

07/10/2001 Not Required Not Required These regulation changes are not 

required to be adopted for purposes of Compatibility. (See STP-98-074) 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package Outgoing 

Package 

Notes 

(Superceded by 2002-2) Alabama has adopted Final 

Regulations equivalent to RATS IDs 2002-2. 

1998-4 Licenses for Industrial Radiography and Radiation 

Safety Requirements for Industrial Radiographic Operations Part 34 63 FR 37059 

07/09/2001 Final No Comments 

08/29/2000 

1998-5 Minor Corrections, Clarifying Changes, and a Minor 

Policy Change Parts 20, 32, 35, 36, 39 63 FR 39477; 63 FR 45393 

10/26/2001 Final No Comments 

08/29/2000 

1998-6 Transfer for Disposal and Manifests: Minor 

Technical Conforming Amendment Part 20 63 FR 50127 

11/20/2001 Final No Comments 

08/29/2000 

1999-1 Radiological Criteria for License Termination of 

Uranium Recovery Facilities Part 40 64 FR 17506 

06/11/2002 Not Applicable Not Applicable Alabama does not have authority to 

regulate this material under its Agreement 

1999-2 Requirements for Those Who Possess Certain 

Industrial Devices Containing Byproduct Material to Provide Requested Information Part 31 64 FR 42269 

10/04/2002 Not Required Not Required These regulation changes are not 

required to be adopted for purposes of Compatibility 

1999-3 Respiratory Protection and Controls to Restrict 

Internal Exposure Part 20 64 FR 54543; 64 FR 55524 

02/02/2003 Final 

ML021090092 

No Comments 04/25/2002 ML021160517 

2000-1 Energy Compensation Sources for Well Logging 

and Other Regulatory Clarifications Part 39 65 FR 20337 

05/17/2003 Final 

ML062000076 

No Comments 08/10/2006 ML062220014 

2000-2 New Dosimetry Technology 01/08/2004 Final No Comments 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package Outgoing 

Package 

Notes 

Parts 34, 36, 39 65 FR 63750 

 ML062000076 08/10/2006 

ML062220014 

2001-1 Requirements for Certain Generally Licensed 

Industrial Devices Containing Byproduct Material Parts 30, 31, 32 65 FR 79162 

02/16/2004 Final 

ML062000076 

No Comments 08/10/2006 ML062220014 

2002-1 Revision of the Skin Dose Limit 

Part 20 67 FR 16298 

04/05/2005 Final 

ML052940420 

No Comments 11/08/2005 ML053120389 

2002-2 Medical Use of Byproduct Material 

Parts 20, 32, 35 67 FR 20249 

10/24/2005 Final 

ML062000076 

No Comments 08/10/2006 ML062220014 

2003-1 Financial Assurance for Materials Licensees 

Parts 30, 40, 70 68 FR 57327 

12/03/2006 Final 

ML062000076 

No Comments 08/10/2006 ML062220014 

2004-1 Compatibility With IAEA Transportation Safety 

Standards and Other Transportation Safety Amendments Part 71 69 FR 3697 

10/01/2007 Final 

ML102080659 

Comments 08/30/2010 ML102170098 

*2005-1 Security Requirements for Portable Gauges 

Containing Byproduct Material Part 30 70 FR 2001 

07/11/2008 Final 

ML13176A135 License Condition ML081960176 

No Comments 09/18/2013 ML13176A123 Comments 07/28/2008 ML082100083 

2005-2 Medical Use of Byproduct Material - Recognition of 

Specialty Boards Part 35 70 FR 16336; 71 FR 1926 

04/29/2008 Final 

ML062000076 

No Comments 08/10/2006 ML062220014 

2005-3 Increased Controls for Risk-Significant Radioactive 

Sources (NRC Order EA-05-090)

70 FR 72128 

12/01/2005 License Condition 

ML052570218 

No Comments 09/15/2005 ML052620319 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package Outgoing 

Package 

Notes 

*2006-1 Minor Amendments 

Parts 20, 30, 32, 35, 40 and 70 71 FR 15005 

03/27/2009 Final 

ML13176A135 

Comments 09/18/2013 ML13176A123 

*2006-2 National Source Tracking System - Serialization 

Requirements Part 32 with reference to Part 20 Appendix E 71 FR 65685 

02/06/2007 Final 

ML13176A135 

Comments 09/18/2013 ML13176A123 

*2006-3 National Source Tracking System 

Part 20 71 FR 65685, 72 FR 59162 

01/31/2009 Final 

ML13176A135 License Condition ML082820556 

No Comments 09/18/2013 ML13176A123 No Comments 10/21/2008 ML082820596 

*2007-1 Medical Use of Byproduct Material - Minor 

Corrections and Clarifications Parts 32 and 35 72 FR 45147, 54207 

10/29/2010 Final 

ML13176A135 

Comments 09/18/2013 ML13176A123 

*2007-2 Exemptions From Licensing, General Licenses, and 

Distribution of Byproduct Material: Licensing and Reporting Requirements Parts 30, 31, 32, 150 72 FR 58473 

12/17/2010 Final 

ML13176A135 

Comments 09/18/2013 ML13176A123 

*2007-3 Requirements for Expanded Definition of Byproduct 

Material Parts 20, 30, 31, 32, 33, 35, 61, 150 72 FR 55864 

11/30/2010 Final 

ML13176A135 

Comments 09/18/2013 ML13176A123 

2007-4 Order Imposing Fingerprinting Requirements and 

Criminal History Records Check Requirements for Unescorted Access to Certain Radioactive Material NRC Order EA-07-305 72 FR 70901 

06/05/2008 License Condition 

ML081090443 

No Comments 05/01/2008 ML081220314 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package Outgoing 

Package 

Notes 

*2008-1 Occupational Dose Records, Labeling Containers, 

and Total Effective Dose Equivalent Parts 19, 20 72 FR 68043 

02/15/2011 Final 

ML13176A135 

No Comments 09/18/2013 ML13176A123 

*2009-1 Medical Use of Byproduct Material – Authorized 

User Clarification Part 35 74 FR 33901 

09/28/2012 Final 

ML13176A135 

Comments 09/18/2013 ML13176A123 

2011-1 Decommissioning Planning 

Parts 20, 30, 40, 70 76 FR 35512 

12/17/2015 

2011-2 Licenses, Certifications, and Approvals for Materials 

Licensees Parts 30, 36, 39, 40, 70, and 150 76 FR 56951 

11/14/2014 

2012-1 Change of Compatibility of 10 CFR 31.5 and 31.6 

(See RATS ID: 2001-1 for Rule text) 77 FR 3640 

01/25/2015 

2012-2 Advance Notification to Native American Tribes of 

Transportation of Certain Types of Nuclear Waste Part 71 77 FR 34194 

08/10/2015 

2012-3 Technical Corrections 

Part 30, 34, 40 and 70 77 FR 39899 

08/06/2015 

2012-4 Requirements for Distribution of Byproduct Material 

Parts 30, 31, 32, 40 and 70 77 FR 43666 

10/23/2015 

2013-1 Physical Protection of Byproduct Material, 10 CFR 

Parts 20, 30, 32, 33, 34, 35, 36, 37, 39, and 71 78 FR 16922 

03/19/2016 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package Outgoing 

Package 

Notes 

2013-2 Distribution of Source Material to Exempt Persons 

and to General Licensees and Revision of General License and Exemptions, 10 CFR Parts 30, 40, and 70 78 FR 32310 

08/27/2016 

1 IMPEP Team: verify that Alabama does not have any licensees subject to these regulations during each review.