February 4, 2004

Mr. Donald A. Flater, Chief

Bureau of Radiological Health

Iowa Department of Public Health

401 SW 7th Street, Suite D

Des Moines, IA 50309

Dear Mr. Flater: 

We have reviewed the final revisions to the Iowa Administrative Code received by our office on

December 30, 2003. In addition, we reviewed your response to our letter dated September 30,

2003, which contained our comments on your proposed version of these rules. These

regulations were reviewed by comparison to the equivalent Nuclear Regulatory Commission

(NRC) regulations in 10 CFR Part 20, 30, 31, 32, 34, 35, 36, 39, 40, 50, 60, 61, 70, 71, 72 and

150 and the requirements of the sixteen amendments identified in the enclosed States

Regulation Status Data Sheet (SRS). We discussed our review of the regulations with

Charlene Craig on February 4, 2004.

As a result of our review, we have six comments that relate to the changes made in response to

our comments from the September 30, 2003 letter and three editorial suggestions. Comments

1-5 relate to the wording of the retention periods for records. There were also three comments

from our September 30 letter that were not addressed, and we have included them in a

separate chart. We understand that you will address these in a future rulemaking. Comment 6

relates to 10 CFR Part 35, Medical Training and Experience (T&E), which is currently

undergoing revision. The State has adopted the requirements of Part 35, Subpart J in place of

the requirements of Part 35.390. Although the State is currently compatible with this

requirement, the NRC is currently revising the Medical T&E sections and when finalized, will

rescind Part 35 Subpart J. Once this occurs, the State will no longer be compatible with the

NRC unless the State adopts the new Medical T&E requirements. Please provide an amended,

final version of your rules showing the location of any changes made, by the State, in response

to our comments. If there are any comments which the State believes are in error, the State

should identify the section of their regulations that meets the designated compatibility category. 

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 adopted, incorporating our

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

safety categories established in the Office of State and Tribal Programs (STP) Procedure SA200.
Mr. Donald A. Flater -2- February 4, 2004

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.hrsd.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 Aaron

McCraw of my staff at (301) 415-1277 or ATM@NRC.GOV. 

Sincerely,

\RA by KNSneider for\

Josephine Piccone, Deputy Director

Office of State and Tribal Programs

Enclosures:

As stated
Mr. Donald A. Flater -2- February 4, 2004

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.hrsd.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 Aaron

McCraw of my staff at (301) 415-1277 or ATM@NRC.GOV. 

Sincerely,

\RA by KNSneider for\

Josephine Piccone, Deputy Director

Office of State and Tribal Programs

Enclosures:

As stated

 Distribution:

DIR RF (4-05) DCD (SP07) PDR (YES) BUsilton

LBolling, ASPO Iowa File Response to Incoming Document: ML033640452

DOCUMENT NAME:C:\ORPCheckout\FileNET\ML040360241.wpd

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 STP OGC STP

NAME AMcCraw JZabko STreby KNSneider for JPiccone

DATE 1/ 07 /04* 1/ 07 /04* 2/04/04* 2/04/04*

ML040360241 OFFICIAL RECORD COPY
EDITORIAL SUGGESTIONS

1. In Appendix C of Chapter 45, the specific section listed for leak test record holding

requirements is listed as 45.3(4). The specific section for leak test record holding

requirements is 45.3(5). Appendix C should be updated to reflect this.

2. In Appendix C of Chapter 45, the record retention interval for utilization logs is listed as

“until disposal is authorized by the agency.” In 641-45.1(7), utilization log records are

required to be held for three years. Appendix C should be updated to reflect this.

3. In Appendix C of Chapter 45, the record retention interval for training and testing records

is listed as “until the agency authorizes disposal.” The State has made changes to 641-

45.1 (10) e. to reflect the minimum of three years retention interval, as found in 10 CFR

34.83. Appendix C should be updated to reflect this change.
COMPATIBILITY COMMENTS ON 

IOWA FINAL REGULATIONS

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

1 45.1(4) 34.63 1997-5 C Records of receipt and transfer of

sealed sources.

The State uses the words “shall be

maintained for agency inspection until

disposal is authorized by the agency”

There is no minimum record retention

length stated. 

The State needs to change their

record retention requirements to three

years, as stated in 34.63 to meet

compatibility.

2 45.1(12) 34.83 1997-5 C Records of personnel monitoring

procedures.

The State’s requirements for retention

of records of pocket dosimeter

readings allows records to be

disposed of when the agency

authorizes disposal, if the dosimeter

readings were used to determine

external dose. The phrase “until the

agency authorizes disposal” does not

meet the same intent as the language

in 10 CFR 34.83. As stated in 34.83,

records need to be maintained for a

period of three years after they are

recorded, regardless of the status of

the license or State approval for

disposal.

The State needs to add additional

language to ensure that records are

maintained for a minimum of three

years to meet compatibility.

3 45.1(12) 34.83 1997-5 C Records of personnel monitoring

procedures.

The State’s requirements for retention

of pocket dosimeter calibrations and 

alarming rate meter calibrations is two

years which is less than the NRC

requirement of three years.

The State needs to adopt the

retention requirements of Part 34.83

to meet compatibility.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

4 45.1(12) 34.83 1997-5 C Records of personnel monitoring

procedures.

The State requirements for record

retention associated with OSL’s

TLD’s and Film Badges are “until the

agency authorizes disposal.” This

statement does not meet the same

intent as the language in 10 CFR

34.83. As stated in 34.83, records

associated with OSL’s TLD’s and Film

Badges need to be maintained until

termination of the license. 

The State needs to adopt the

retention requirements of Part 34.83

to meet compatibility.

5 45.1(19)

Appendix C

34.81 1997-5 C Copies of operating and

emergency procedures.

The State uses the phrase “until

disposal is authorized by the agency.”

The phrase does not meet the same

intent as the language in 10 CFR

34.81. This phraseology is different

in meaning than the NRC’s

requirement of “until the Commission

terminates the license and three

years after a change is made.”

The State needs to adopt similar

wording to 34.81 to meet

compatibility. 

6 N/A 35.390 2002-2 B Training for use of unsealed

byproduct material for which a

written directive is required

The State has adopted the training

requirements of 10 CFR Part 35

Subpart J in place of Part 35.390.

Although the State is currently

compatible, the State will have to

adopt Part 35.390 after Subpart J is

rescinded.
COMPATIBILITY COMMENTS ON IOWA FINAL REGULATIONS

FROM NRC LETTER DATED SEPTEMBER 30, 2003

1 N/A 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 omitted the training

requirements of Part 35.392.

The State needs to adopt the training

requirements of Part 35.392 to meet

compatibility.

2 N/A 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)

The State omitted the training

requirements of Part 35.394.

The State needs to adopt the training

requirements of Part 35.394 to meet

compatibility.

3 41.2 (73) 35.690 2002-2 B Training for use of remote

afterloader units, teletherapy units,

and gamma stereotactic

radiosurgery units

The State does not fully meet the

training requirements of 10 CFR

35.690. The requirements of 35.690

(b)(3) are missing.

The State needs to adopt all the

training requirements of 10 CFR

35.690 to achieve compatibility.
STATE REGULATION STATUS

State: IOWA[Sixteen amendments reviewed are identified by a  Tracking Ticket Number: 

at the beginning of each equivalent NRC regulation.] Date: February 4, 2004 

NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / ML 

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

P

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

Notification of Incidents-Parts 20, 30, 31, 34, 39, 40, 70 56 FR 64980; (10/15/94) 1991-4Quality Management Program and Misadministrations-Part 35 56 FR 34104; (1/27/95) 1992-1Eliminating the Recordkeeping Requirements for Departures from Manufacturer’s InstructionsParts 30,35 57 FR 45566; (none) 1992-2 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 Decommissioning Recordkeeping and License Termination: Documentation Additions[Restricted areas and spill sites]-Parts 30, 40 

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

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) 1994-2Timeliness in Decommissioning Material Facilities-Parts 30, 40, 70 59 FR 36026; (8/15/97) 1994-3Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for MedicalUse-Parts 30, 32, 35

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

1995-1 F

P

Frequency of Medical Examinations for Use of Respiratory Protection Equipment-Part 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

P

Radiation Protection Requirements: Amended Definitions and Criteria-Parts 19, 20 60 FR 36038; (8/14/98) 1995-5 F 
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / ML 

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

ML036404

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

ML036404

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

ML036404

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

ML036404

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

ML036404

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

ML036404

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

ML036404

Self-Guarantee of Decommissioning Funding by Nonprofit and Non-Bond-Issuing LicenseesParts 30, 40, 70 63 FR 29535; (none) 1998-2 FML036404

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 P 

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

ML036404

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

ML036404
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / 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 Number

Radiological Criteria for License Termination of Uranium Recovery Facilities-Part 40 64 FR 17506; (6/11/02) 1999-1Requirements 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

ML036404

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

ML036404

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

ML036404

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

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

ML036404

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

ML036404

Medical Use of Byproduct Material - Parts 20, 32, and 35 67 FR 20249; (4/24/05) 2002-2 F

ML036404

Financial Assurance for Materials Licensees 

– Parts 30, 40, 70 68 FR 57327 12/3/06 2003-1