April 3, 2006

Kirksey Whatley, Director

Alabama Office of Radiation Control

PO Box 303017

Montgomery AL 36130-3017

Dear Mr. Whatley:

We have reviewed the proposed changes to the Alabama regulations in the Alabama

Radiological Health Rules 420-3-26-.07, “Use of Radionuclides in the Healing Arts,” received by

our office on February 15, 2006. These regulations were reviewed by comparison to the

equivalent Nuclear Regulatory Commission (NRC) rules in 10 CFR Parts 20, 32 and 35 and the

requirements of the two amendments identified in the enclosed State Regulation Status (SRS)

Data Sheet. We discussed our review of the regulations with David Walter on April 3, 2006.

As a result of our review, we have nine comments that have been identified in the enclosure. 

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 Alabama 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 Alabama 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 State and Tribal Programs (STP) Procedure SA-200.

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 requested in STP

Procedure SA-201, “Review of State Regulatory Requirements,” please highlight the final

changes and provide a copy to STP.

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 STP website: http://www.hsrd.ornl.gov/nrc/rulemaking.htm. 

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 me, or Mr. Osiris

Siurano at 301-415-2307 or by e-mail at osp@nrc.gov.

Sincerely,

\RA By KNSchneider For\

Dennis K. Rathbun, Deputy Director

Office of State and Tribal Programs

Enclosures: 

As stated
April 3, 2006

Kirksey Whatley, Director

Alabama Office of Radiation Control

PO Box 303017

Montgomery AL 36130-3017

Dear Mr. Whatley:

We have reviewed the proposed changes to the Alabama regulations in the Alabama

Radiological Health Rules 420-3-26-.07, “Use of Radionuclides in the Healing Arts,” received by

our office on February 15, 2006. These regulations were reviewed by comparison to the

equivalent Nuclear Regulatory Commission (NRC) rules in 10 CFR Parts 20, 32 and 35 and the

requirements of the two amendments identified in the enclosed State Regulation Status (SRS)

Data Sheet. We discussed our review of the regulations with David Walter on April 3, 2006.

As a result of our review, we have nine comments that have been identified in the enclosure. 

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 Alabama 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 Alabama 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 State and Tribal Programs (STP) Procedure SA-200.

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 requested in STP

Procedure SA-201, “Review of State Regulatory Requirements,” please highlight the final

changes and provide a copy to STP.

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 STP website: http://www.hsrd.ornl.gov/nrc/rulemaking.htm. 

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 me, or Mr. Osiris

Siurano at 301-415-2307 or by e-mail at osp@nrc.gov.

Sincerely,

\RA By KNSchneider For\

Dennis K. Rathbun, Deputy Director

Office of State and Tribal Programs

Enclosures: As stated

Distribution:

DIR RF ([6-53]) SISP Review Complete

DCD (SP05) G Publicly Available G Non-Publicly Available

SMinnick, RSAO G Non-Sensitive G Sensitive

SSmith, ASPO WRautzen Alabama File

DOCUMENT NAME: E:\Filenet\ML060960005.wpd Document:ML060540346 

To receive a copy of this document, indicate in the box: "C" = Copy without attachment/enclosure "E" = Copy with

attachment/enclosure "N" = No copy

OFFICE STP OGC STP:DD

NAME OSiurano STreby KNSchneider for DRathbun

DATE 3/16/2006* 3/30/2006* 4/03/2006*

ML060960005 OFFICIAL RECORD COPY
COMPATIBILITY COMMENTS ON ALABAMA PROPOSED REGULATIONS

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

1 420-3-26-

.07(2)(d)

§35.2 2002-2 B Definition: Authorized medical

physicist

Alabama has incorrect references to

420-3-26-.07(27) and (29) regarding

the requirements of the authorized

medical physicist. The correct

references are in the State sections

420-3-26-.07(27) and (30).

Alabama needs to correct the

references in 420-3-26.07(2)(d) to

meet the compatibility category B

assigned to 10 CFR 35.2.

2 420-3-26-

.07(2)(d)

§35.2 2002-2 B Definition: Authorized medical

physicist

The State regulation requires that the

individual must meet the

requirements in (27) or (30), and

other requirements. Requirements in

(27) and (30) should be inclusive (i.e.,

and) and exclusive (i.e., or) for the

other requirements.

Alabama needs to correct this to

meet the compatibility category B

assigned to 10 CFR 35.2.

3 420-3-26-

.07(2)(e)

§35.2 2002-2 B Definition: Authorized nuclear

pharmacist

Alabama has incorrect references to

420-3-26-.07(28) and (29) regarding

the requirements of the authorized

nuclear pharmacist. The correct

references are in State sections 420-

3-26-.07(27) and (30).

Alabama needs to correct the

references in 420-3-26.07(2)(e) to

meet the compatibility category B

assigned to 10 CFR 35.2.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

4 420-3-26-

.07(2)(e)

§35.2 2002-2 B Definition: Authorized nuclear

pharmacist

The State regulation requires that the

individual must meet the

requirements in (28) or (30), and

other requirements. Requirements in

(28) and (30) should be inclusive (i.e.,

and) and exclusive (i.e., or) for the

other requirements.

Alabama needs to correct this to

meet the compatibility category B

assigned to 10 CFR 35.2.

5 420-3-26-

.07(2)(bb)

§35.2 2002-2 C Definition: Prescribed dosage

Alabama has incorrect references to

420-3-26-.07(2)(bb), which are not

equivalent to §35.100 and §35.200. 

The correct State sections equivalent

to §35.100 and §35.200 are 420-3-

26-.07(45) and (48).

Alabama needs to correct the

references in 420-3-26-.07(2)(bb) to

meet the compatibility category C

assigned to 10 CFR 35.2.

6 420-3-26-

.07(2)(ee)

§35.2 2005-2 B Definition: Radiation Safety Officer

Alabama has incorrect references to

420-3-26-.07(27) and (29) regarding

the requirements of the radiation

safety officer. The correct references

are in State sections 420-3-26-

.07(27) and (30).

Alabama needs to correct the

references in 420-3-26-.07(27) and

(29) to meet the compatibility

category B assigned to this definition.

7 420-3-26-

.07(2)(ee)

§35.2 2005-2 B Definition: Radiation Safety Officer

The State regulation requires that the

individual must meet the

requirements in (26) or (30). These

requirements should be inclusive (i.e.,

and).

Alabama needs to correct this to

meet the compatibility category B

assigned to this definition.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

8 420-3-26-

.07(26)

§35.50 2002-2 B Training for Radiation Safety

Officer 

Alabama incorrectly referenced 420-

3-26-.07(51)(a) regarding the rule

under which a specialty board’s

certification process is recognized in

420-3-26-.07(26)(c)(1). The correct

reference should be to State section

420-3-26-.07(27)(a).

Alabama needs to correct the

references in 420-3-26-07(26)(c)(1) to

meet the compatibility category B

assigned to 10 CFR 35.50.

9 420-3-26-

.07(48)

§35.200 2002-2 H&S Use of Unsealed Byproduct

Material for Imaging and

Localization Studies for Which a

Written Directive is not Required

The State regulation requires that

radioactive material for imaging and

localization studies be prepared by an 

authorized nuclear pharmacist or

physician who meets the

requirements in 420-3-26-.07(51). 

The state did not include 420-3-26-

.07(56) as an exclusive (i.e., or)

requirement that this individual may

also meet. 

Alabama needs to revise 420-3-26-

.07(48) to meet the compatibility

category H&S assigned to 10 CFR

35.200.
STATE REGULATION STATUS

State: Alabama[2 amendments reviewed are identified Trackinby a i at the beginning of each equivalent NRC regulation] Date: A

NRC Chronology Identification FR Notice

(Date Due for StateImplementation)

RATS ID

Proposed / Final (F)

Rule / LicCondition(LC) ML #

Safety Requirements for Radiographic Equipment-Part 34 55 FR 843; (1/10/94) 1991-1 F ANT Certification of Radiographers-Part 34 56 FR 11504; (none) 1991-2 

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; (1/1/94)

1991-3 F 

Notification of Incidents-Parts 20, 30, 31, 34, 39, 40, 70 56 FR 64980; (10/15/94) 1991-4 F Quality Management Program and Misadministrations-Part 35 56 FR 34104; (1/27/95) 1992-1 F Eliminating the Recordkeeping Requirements for Departures from Manufacturer'sInstructions-Parts 30, 35

57 FR 45566; (none) 1992-2 

Decommissioning Recordkeeping and License Termination: Documentation Additions[Restricted areas and spill sites]-Parts 30, 40 

58 FR 39628; (10/25/96) 1993-1 F 

Licensing and Radiation Safety Requirements for Irradiators-Part 36 58 FR 7715; (7/1/96) 1993-2 F Definition of Land Disposal and Waste Site QA Program-Part 61 58 FR 33886; (7/22/96) 1993-3 Self-Guarantee as an Additional Financial Mechanism-Parts 30, 40, 70 58 FR 68726; 59 FR 1618

(none)

1994-1 F 

Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPA StandardsPart 40 59 FR 28220; (7/1/97) 1994-2 Timeliness in Decommissioning Material Facilities-Parts 30, 40, 70 59 FR 36026; (8/15/97) 1994-3 F Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material forMedical Use-Parts 30, 32, 35

59 FR 61767; 59 FR 6524360 FR 322; (1/1/98)

1995-1 F 

Frequency of Medical Examinations for Use of Respiratory Protection EquipmentPart 20 60 FR 7900; (3/13/98) 1995-2 F Low-Level Waste Shipment Manifest Information and Reporting-Parts 20, 61 60 FR 15649; 60 FR 25983

(3/1/98)

1995-3 F 

Performance Requirements for Radiography Equipment-Part 34 60 FR 28323; (6/30/98) 1995-4 F 
NRC Chronology Identification FR Notice

(Date Due for StateImplementation)

RATS ID

Proposed / Final (F)

Rule / LicCondition(LC) ML #

Radiation Protection Requirements: Amended Definitions and Criteria-Parts 19, 20 60 FR 36038; (8/14/98) 1995-5 F Clarification of Decommissioning Funding Requirements-Parts 30, 40, 70 60 FR 38235; (11/24/98) 1995-6 F  Medical Administration of Radiation and Radioactive Materials-Parts 20, 35 60 FR 48623; (10/20/98) 1995-7 F 10 CFR Part 71: Compatibility with the International Atomic Energy Agency-Part 71 60 FR 50248; 61 FR 28724

(4/1/99)

1996-1 F 

One Time Extension of Certain Byproduct, Source and Special Nuclear MaterialsLicenses-Parts 30, 40, 70

61 FR 1109; (none) 1996-2 

Termination or Transfer of Licensed Activities: Record keeping Requirements-Parts 20,30, 40, 61, 70

61 FR 24669; (6/17/99) 1996-3 F 

Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean AirAct-Part 20

61 FR 65120; (1/9/00) 1997-1 F 

Recognition of Agreement State Licenses in Areas Under Exclusive Federal JurisdictionWithin an Agreement State-Part 150

62 FR 1662; (2/27/00) 1997-2 F 

Criteria for the Release of Individuals Administered Radioactive Material-Parts 20, 35 62 FR 4120; (5/29/00) 1997-3 F Fissile Material Shipments and Exemptions-Part 71 62 FR 5907; (none) 1997-4 Licenses for Industrial Radiography and Radiation Safety Requirements for IndustrialRadiography Operations-Parts 30, 34, 71, 150

62 FR 28947; (6/27/00) 1997-5 F 

Radiological Criteria for License Termination-Parts 20, 30, 40, 70 62 FR 39057; (8/20/00) 1997-6 F Exempt Distribution of a Radioactive Drug Containing One Micro curie of Carbon-14 UreaPart 30 62 FR 63634; (1/02/01) 1997-7 F Deliberate Misconduct by Unlicenced Persons-Parts 30, 40, 61, 70, 71, 150 63 FR 1890; 63 FR 13773

(2/12/01)

1998-1 F 

Self-Guarantee of Decommissioning Funding by Nonprofit and Non-Bond-IssuingLicensees- Parts 30, 40, 70

63 FR 29535; (none) 1998-2 

License Term for Medical Use Licenses-Part 35 63 FR 31604; (none) 1998-3 Licenses for Industrial Radiography and Radiation Safety Requirements for IndustrialRadiographic Operations-Part 34

63 FR 37059; (7/9/01) 1998-4 F 
NRC Chronology Identification FR Notice

(Date Due for StateImplementation)

RATS ID

Proposed / Final (F)

Rule / LicCondition(LC) ML #

Minor Corrections, Clarifying Changes, and a Minor Policy Change-Parts 20, 35, 36 63 FR 39477; 63 FR 45393

(10/26/01)

1998-5 F 

Transfer for Disposal and Manifests: Minor Technical Conforming Amendment-Part 20 63 FR 50127; (11/20/01) 1998-6 F Radiological Criteria for License Termination of Uranium Recovery Facilities-Part 40 64 FR 17506; (6/11/02) 1999-1 

Requirements for Those Who Possess Certain Industrial Devices Containing ByproductMaterial to Provide Requested Information-Part 31

64 FR 42269; (none) 1999-2 

Respiratory Protection and Controls to Restrict Internal Exposure-Part 20 64 FR 54543; 64 FR 55524

(2/2/03)

1999-3 F

ML021090

Energy Compensation Sources for Well Logging and Other Regulatory Clarifications-Part39

65 FR 20337; (5/17/03) 2000-1 P

ML050130

New Dosimetry Technology-Parts 34, 36, 39 65 FR 63750; (1/8/04) 2000-2Requirements for Certain Generally Licensed Industrial Devices Containing ByproductMaterial - Parts 30, 31, 32

65 FR 79162; (2/16/04) 2001-1 P 

ML050130

Revision of the Skin Dose Limit -Part 20 67 FR 16298; (4/5/05) 2002-1 F

ML052940

i Medical Use of Byproduct Material-Parts 20, 32, and 35 67 FR 20249; (10/24/05) 2002-2 P

ML060540

Financial Assurance for Materials Licensees – Parts 30, 40, 70 68 FR 57327; (12/3/06) 2003-1Compatibility With IAEA Transportation Safety Standards and Other Transportation SafetyAmendments – Part 71.

69 FR 3697; (10/01/07) 2004-1

Security Requirements for Portable Gauges Containing Byproduct Material - Part 30 70 FR 2001; (7/11/08) 2005-1

i Medical Use of Byproduct Material - Recognition of Specialty Boards - Part 35 70 FR 16336; 71 FR 1926

(4/29/08)

2005-2 P

ML060540

Increased Controls for Risk-Significant Radioactive Sources (NRC Order EA-05-090)6 70 FR 72128; (12/1/05) 2005-3 LC

ML0525702
1. Or other generic Legally Binding Requirements.

2. (Y/N) Y means “Yes,” there are comments in the review letter that the State needs to address. 

N means “No,” there are no comments in the review letter.

3. Not Required means these regulations are not required for purposes of compatibility.4. A State need not adopt a specific regulation if the State has no licensees that would be subject to the regulation. See: “Final Policy 

Adequacy and Compatibility of Agreement State Programs,” III.1.Time From For Adoption of Compatible State Regulations, p. 6, S1995.

5. ADAMS ML Number.6. By letter dated September 2, 2005, from Paul H. Lohaus, Director, Office of State and Tribal Programs, Agreeme

days to issue legally binding requirements satisfying the requirements of NRC Order EA-05-090.