September 24, 2007

Ms. Melanie Rasmusson, MBA, Chief

Iowa Department of Public Health

Bureau of Radiological Health

Lucas State Office Building

321 E. 12th Street

Des Moines, Iowa 50319-0075

Dear Ms. Rasmusson:

We have reviewed the final revision to the Iowa regulations 641-38 “General Provisions for

Radiation Machines and Radioactive Material,” 641-39 “Registration of Radiation Machine

Facilities, Licensure of Radioactive Materials and Transportation of Radioactive Materials,” 641-

40 “Standards for Protection Against Radiation,” and 641-41 “Safety Requirements for the Use

of Radiation Machines and Certain Uses of Radioactive Materials,” received by our office on

July 16, 2007. These regulations were reviewed by comparison to the equivalent Nuclear

Regulatory Commission (NRC) rules in 10 CFR Parts 20, 30, 31, 32, 34, 35, 39, 40, 61, 70, and

71 and the requirements of the 13 amendments identified in the enclosed State Regulation

Status (SRS) Data Sheet. We discussed our review of the regulations with Randy Dahlin on

September 21, 2007.

As a result of our review, we have 11 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. We have determined that if these regulations are revised, incorporating our

comments and without other significant change, they would meet the compatibility and health

and safety categories established in the Office of Federal and State Materials and

Environmental Management Programs (FSME) Procedure SA-200.

We request that when you revise your regulations to address our comments, 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 location of any changes made

by Iowa, in response to our comments, 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 Iowa 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. 
Ms. Melanie Rasmusson, MBA, Chief -2- September 24, 2007

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, Kathleen

Schneider, State Regulation Review Coordinator at 301-415-2320 or by e-mail at

KXS@nrc.gov, or Kim Lukes at 301-415-6701 or by e-mail at KXK2@nrc.gov.

Sincerely,

\RA By ADWhite For\

Robert J. Lewis, Deputy Director

Division of Materials Safety and State Agreements

Office of Federal and State Materials and

Environmental Management Programs

Enclosures: 

 As stated
Ms. Melanie Rasmusson, MBA, Chief -2- September 24, 2007

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, Kathleen

Schneider, State Regulation Review Coordinator at 301-415-2320 or by e-mail at

KXS@nrc.gov, or Kim Lukes at 301-415-6701 or by e-mail at KXK2@nrc.gov.

Sincerely,

\RA By ADWhite For\

Robert J. Lewis, Deputy Director

Division of Materials Safety and State Agreements

Office of Federal and State Materials and

Environmental Management Programs

Enclosures: 

 As stated

Distribution:

DIR RF (7-55) SUNSI Review Complete

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

Jim Lynch, RSAO : Non-Sensitive G Sensitive

Aaron McCraw Iowa File

DOCUMENT NAME: C:\FileNet\ML072670007.wpd 

ML of Incoming Document:ML071970162

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 SAIS SAIS OGC SAIS:BC MSSA:DD

NAME KLukes KSchneider CCameron DWhite RLewis

DATE 8/16/07* 8/20/07* 9/13 /07* 9/24/07* 9/24/07*

ML072670007 OFFICIAL RECORD COPY
COMPATIBILITY COMMENTS ON IOWA FINAL REGULATIONS

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

1 641-39.4

(33)

§70.38

(c)(d)(e)

(f)(g)(h)(i)(j)&

(k)(1),(2),(3)

1994-3 H&S Expiration and termination of

licenses and decommissioning of

sites and separate buildings or

outdoor areas

State regulation 39.4(33) is missing

the wording under 10 CFR

70.38(g)(4)(vi) on a description of the

physical security plan and material

control and accounting plan

provisions. The State needs to add

this provision in order to meet the

Compatibility Category H&S

designation assigned to 10 CFR

70.38.

2 641-Chapter

40 Appx. D

Part 20 

Appendix G

1995-3 B Requirements for Transfers of

Low-Level Radioactive Waste

Intended for Disposal at Licensed

Land Disposal Facilities and

Manifests

State regulation Chapter 40,

Appendix D, Section I.(c) reflects the

organizational unit that was in

existence in 1995. The State needs

to revise the references to NRC to

reflect the current organizational

changes and website reference in

order to meet the Compatibility

Category B designation assigned to

10 CFR 20.2006. 

3 641-41.2(69) § 35.390 2002-2 B Training for use of unsealed

byproduct material for which a

written directive is required

State regulation 41.2(69) incorrectly

references “10 CFR 35.930" instead

of “10 CFR 35.390.” The State needs

to revise the references to 10 CFR

35.390 in order to meet the

Compatibility Category B designation

assigned to 10 CFR 35.390.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

4 641-41.2(81) §35.392 2002-2 B Training for the oral administration

of sodium iodide I-131 requiring a

written directive in quantities less

than or equal to 1.22

Gigabecquerels (33 millicuries)

State regulation 41.2(81) incorrectly

references “10 CFR 35.930, 35.932,

and 35.934.” The State needs to

revise the references to 10 CFR

35.390, 35.392, and 35.394 in order

to meet the Compatibility Category B

designation assigned to 10 CFR

35.392.

5 641-41.2(82) §35.394 2002-2 B Training for the oral administration

of sodium iodide I-131 requiring a

written directive in quantities 

greater than 1.22 Gigabecquerels

(33 millicuries)

State regulation 41.2(82) incorrectly

references “10 CFR 35.930 and

35.934.” The State needs to revise

these references to 10 CFR 35.390

and 35.394 in order to meet the

Compatibility Category B designation

assigned to 10 CFR 35.394.

6 641-41.2(73) §35.690 2002-2 B Training for use of remote

afterloader units teletherapy units,

and gamma stereotactic

radiosurgery units

State regulation 41.2(73) incorrectly

references “10 CFR 35.960.” The

State needs to revise this reference

to 10 CFR 32.690 in order to meet

the Compatibility Category B

assigned to 10 CFR 35.690.

7 641-39.4

(29)l.

§ 32.74 2006-1 B Manufacture and distribution of

sources or devices containing

byproduct material for medical use

State regulation 39.4 (29)l. is missing

the equivalent reference to 10 CFR

35.600, as indicated under 10 CFR

32.74(a). The State needs to

reference the equivalent regulation to

10 CFR 35.600 in order to meet the

Compatibility Category B assigned to

10 CFR 32.74.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

8 641-

41.2(74),

641-

41.2(31),

641-41.2

(67), 641-

41.2(68),

641-

41.2(69),

641-

41.2(81),

641-

41.2(82),

641-

41.2(89),

641-

41.2(70),

641-

41.2(71),

and 641-

41.2(73)

§ 35.51, §

35.100, § 35.190,

§ 35.290, §

35.390, § 35.392,

§ 35.394, §

35.396, § 35.490,

§ 35.491, and §

35.690

2006-1 B, H&S, B,

B, B, B, B,

B, B, B, B

Training for an authorized medical

physicist

Use of unsealed byproduct

material for uptake, dilution, and

excretion studies for which a

written directive is not required

Training for uptake, dilution, and

excretion studies

Training for imaging and

localization studies

Training for use of unsealed

byproduct material for which a

written directive is required

Training for the oral

administration of sodium iodide

I–131 requiring a written directive

in quantities less than or equal to

1.22 gigabecquerels (33

millicuries)

Training for the oral

administration of sodium iodide

I–131 requiring a written directive

in quantities greater than 1.22

gigabecquerels (33

millicuries)

Training for the parenteral

administration of unsealed

byproduct material requiring a

written directive

Training for use of manual

brachytherapy sources

Training for ophthalmic use of

strontium-90

Training for use of remote

afterloader units, teletherapy units,

and gamma stereotactic

radiosurgery units
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

8 (cont.) (cont.) (cont.) (cont.) In the sections identified, the State

incorrectly references “10 CFR

35.961" in 41.2(74)(b)(2), “10 CFR

35.920" in 41.2(31)(b)(2), “10 CFR

35.910, 35.920, and 35.930" in

41.2(67), “10 CFR 35.920" in

41.2(68), “10 CFR 35.930" in

41.2(69), “10 CFR 35.930, 35.932,

and 35.934" in 41.2(81), “10 CFR

35.35.930 and 35.934" in 41.2(82),

“10 CFR 35.930, 35.940, and 35.960"

in 41.2(89), “10 CFR 35.940" in

41.2(70), “10 CFR 35.940 and

35.941" in 41.2(71), and “10 CFR

35.960" in 41.2(73). The State needs

to revise these various references to

the correct 10 CFR regulations in

order to meet the respective

Compatibility Category designations

assigned to these regulations.

9 641-41.2

(33)

§ 35.200 2006-1 H&S Use of unsealed byproduct

material for imaging and

localization studies for which a

written directive is not required.

State regulation 41.2(33)(b) is

missing an equivalent reference to 10

CFR 35.390, as referenced under 10

CFR 35.200(b)(2). The State needs

to reference 41.2(69), which is the

equivalent regulation to 10 CFR

35.390, in order to meet the

Compatibility Category H&S

designation assigned to 10 CFR Part

35.200.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

10 641-41.2(68) § 35.290 2006-1 B Training for imaging and

localization studies.

State regulation 41.2 (68)(a)(1) states

“...for uptake, dilution, and excretion

studies....” The State needs to

change this text to “...for imaging and

localization studies....”, as stated

under 10 CFR 35.290(a)(1), in order

to meet the Compatibility Category B

designation assigned to 10 CFR

35.290. 

11 641-40.2(2) §20.1003 2006-3 B Definitions-Nationally tracked

sources

Appendix H of the States regulation

641 Chapter 40 states 15.0 as the

Category 2 Curie value for Curium244. Appendix E of 10 CFR Part 20

indicates 14 as the Category 2 Curie

value for Curium-244. The State

needs to revise this Curie value from

15 to 14 in order to meet the

Compatibility Category B designation

assigned to 10 CFR 20.1003.
STATE REGULATION STATUS

 State: IOWA T 13 Amendments reviewed identified by a i at the 

 beginning of the equivalent NRC requirement]

 NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / LicCondition(LC) ML #

Safety Requirements for Radiographic Equipment-Part 34 55 FR 843; (1/10/94) 1991-1 ASNT 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 

iNotification of Incidents-Parts 20, 30, 31, 34, 39, 40, 70 56 FR 64980; (10/15/94) 1991-4 F

ML071970

Quality Management Program and Misadministrations-Part 35 56 FR 34104; (1/27/95) 1992-1 Eliminating the Recordkeeping Requirements for Departures from Manufacturer's InstructionsParts 30,35 57 FR 45566; (none) 1992-2 iDecommissioning Recordkeeping and License Termination: Documentation Additions[Restricted areas and spill sites]-Parts 30, 40

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

ML071970

Licensing and Radiation Safety Requirements for Irradiators-Part 36 58 FR 7715; (7/1/96) 1993-2 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 

Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPA Standards-Part 40 59 FR 28220; (7/1/97) 1994-2 iTimeliness in Decommissioning Material Facilities-Parts 30, 40, 70 59 FR 36026; (8/15/97) 1994-3 F

ML071970

iPreparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical

Use-Parts 30, 32, 35

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

1995-1 F

ML071970

iFrequency of Medical Examinations for Use of Respiratory Protection Equipment-Part 20 60 FR 7900; (3/13/98) 1995-2 F

ML071970
 NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / LicCondition(LC) ML #

iLow-Level Waste Shipment Manifest Information and Reporting-Parts 20, 61 60 FR 15649; 60 FR 25983

(3/1/98)

1995-3 F

ML071970

Performance Requirements for Radiography Equipment-Part 34 60 FR 28323; (6/30/98) 1995-4 P

ML003692

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

ML033640

One Time Extension of Certain Byproduct, Source and Special Nuclear Materials LicensesParts 30, 40, 70 61 FR 1109; (none) 1996-2 Termination or Transfer of Licensed Activities: Recordkeeping 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 Air ActPart 20 61 FR 65120; (1/9/00) 1997-1 F Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Within

an Agreement State-Part 150

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

ML033640

Criteria for the Release of Individuals Administered Radioactive Material-Parts 20, 35 62 FR 4120; (5/29/00) 1997-3 F 

ML033640

Fissile Material Shipments and Exemptions-Part 71 62 FR 5907; (none) 1997-4 F

ML033640

 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

ML050320

Radiological Criteria for License Termination-Parts 20, 30, 40, 70 62 FR 39057; (8/20/00) 1997-6 F

ML033640

Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 UreaPart 30 62 FR 63634; (1/02/01) 1997-7 F Deliberate Misconduct by Unlicensed Persons-Parts 30, 40, 61, 70, 71, 150 63 FR 1890; 63 FR 13773

(2/12/01)

1998-1 F

ML033640
 NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / LicCondition(LC) ML #

Self-Guarantee of Decommissioning Funding by Nonprofit and Non-Bond-Issuing LicenseesParts 30, 40, 70 63 FR 29535; (none) 1998-2 FML033640License 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 R8

ML003692

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

ML033640

Transfer for Disposal and Manifests: Minor Technical Conforming Amendment-Part 20 63 FR 50127; (11/20/01) 1998-6 F

ML033640

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

ML033640

Energy Compensation Sources for Well Logging and Other Regulatory Clarifications-Part 39 65 FR 20337; (5/17/03) 2000-1 F

ML033640

New Dosimetry Technology-Parts 34, 36, 39 65 FR 63750; (1/8/04) 2000-2 F

ML033640

Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material- Parts 30, 31, 32

65 FR 79162; (2/16/04) 2001-1 F7

ML071560

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

ML033640

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

ML071970
 NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / LicCondition(LC) ML #

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 that regulation. See: “Final 

Adequacy and Compatibility of Agreement State Programs,” III.1. Time Frame for Adoption of Compatible State Regulations, p

1995.

5. ADAMS ML Number6. By letter dated September 2, 2005, from Paul H. Lohaus, Director, Office of State and Tribal Programs, Agreement States were 

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

7. A re-review was completed on this item due to change in compatibility of 31.5 and 31.6. More information can be found in the 

letter STP 05-072.

8. R stands for proposed changes made to final regulations.9. RATS ID 2006-3 will not be considered under the Non-Common Performance Indicator “Compatibility Requirements” for IMPE

as the National Source Tracking System is ready for use Revisions in the implementation date for Agreement States will be p

under separate correspondence and the SRS sheet will be revised as appropriate.

iFinancial Assurance for Materials Licensees – Parts 30, 40, 70 68 FR 57327 (12/3/06) 2003-1 F

ML071970

iCompatibility With IAEA Transportation Safety Standards and Other Transportation Safety

Amendments – Part 71.

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

ML071970

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

ML071970

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

(4/29/08)

2005-2 F

ML071560

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

ML053550LCML052520

iMinor Amendments - Parts 20, 30, 32, 35, 40, and 70 71 FR 15005 (3/27/09) 2006-1 F

ML071970

iNational Source Tracking System - Serialization Requirements - Part 32 with reference toPart 20 Appendix E

71 FR 65685 (2/6/07) 2006-2 F

ML071970

iNational Source Tracking System - Part 20 71 FR 65865 (11/15/07) &

(11/30/07)

2006-39 F

ML071970