September 30, 2003

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

August 8, 2003. In addition, we reviewed your responses to our letters, dated March 22, 2002;

November 12, 2002 and February 12, 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, 52, 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 September 10, 2003.

As a result of our review, we have 11 comments and four editorial suggestions. Comments 

6-10 relate to the Part 35, Medical Training and Experience sections, which is currently

undergoing revision. If the State did not incorporate these sections, due to this revision of Part

35, it would be acceptable for the State to wait until after the revision is published to make these

corrections. 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

meet 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 SA-200.

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 C. Maupin for J. Piccone/

Josephine Piccone, Deputy Director

Office of State and Tribal Programs

Enclosures: As stated
September 30, 2003

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

August 8, 2003. In addition, we reviewed your responses to our letters, dated March 22, 2002;

November 12, 2002 and February 12, 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, 52, 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 September 10, 2003.

As a result of our review, we have 11 comments and four editorial suggestions. Comments 

6 - 10 relate to the Part 35, Medical Training and Experience sections, which is currently

undergoing revision. If the State did not incorporate these sections, due to this revision of Part

35, it would be acceptable for the State to wait until after the revision is published to make these

corrections. 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

meet 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 SA-200.

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 C.Maupin for J.M. Piccone/

Josephine Piccone, Deputy Director

Office of State and Tribal Programs

Enclosures: As stated

Distribution:

DIR RF [3-194] DCD (SP07) PDR (YES_)

LBolling, ASPO Iowa File Response to Incoming Document: ML03167018

DOCUMENT NAME: C:\ORPCheckout\FileNET\ML032740187.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:DD

NAME AMcCraw JZabko STreby CMaupin for JPiccone

DATE 9/9/03* 9/9/03* 9/29/03* 9/30/03*

ML032740187 OFFICIAL RECORD COPY
EDITORIAL SUGGESTIONS

1. In 641-39.4(29) j., the State should change the phrase “for material use” in the title to “for medical

use.”

2. In 641—45.1(136C), definitions section, In the definition of “certifying entity” and “independent

certifying organization” Iowa’s appendix E to Chapter 45 is referenced. This reference should be

removed because Iowa adopted the certifying entity requirement of 10 CFR 34 by reference and

this makes this reference obsolete. Also Appendix E to this chapter is the radiographer

certification training requirements. (Also see comment next editorial suggestion)

3. Appendix E to Chapter 45 is labeled incorrectly. It should be labeled as the “subjects to be

included in training courses for radiographers” not “subjects to be included in training courses for

logging supervisors.

4. In 641-45.1 (10) e., after “until disposal is authorized by the Agency”, the State should add “but in

no case for less than three years” or similar wording for clarity.
COMPATIBILITY COMMENTS ON 

IOWA FINAL REGULATIONS

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

1 45.3 (5) c. 34.67 1997-5 C Records of leak testing of sealed

sources and devices containing

depleted uranium

State rules require leak testing records to

be held for six months after the next leak

test is performed. 10 CFR 34.67 requires

the records to be held for three years.

The State needs to change their

requirements for holding records to three

years as specified in 34.67 to meet

compatibility.

2 45.1 (6)

45.1 (8)

45.1 (10)c

34.69

34.73

34.83

1997-5 C -Records of quarterly inventory

-Records of inspection and

maintenance of radiographic exposure

devices, transport and storage

containers, associated equipment,

source changers, and survey

instruments

-Records of personnel monitoring

Procedures

State requires records to be held for two

years. 10 CFR Parts 34.69, 34.73, and

34.83 require a three year holding period.

The State needs to adopt the three year

holding period as specified in Parts

34.67, 34.73, and 34.83 to meet

compatibility.

3 45.1 (8) 34.73 (b) 1997-5 C Records of inspection and

maintenance of radiographic exposure

devices, transport and storage

containers, associated equipment,

source changers, and survey

instruments

State omitted the requirements of

34.73 (b), which define what

information must be listed on the

records.

The State needs to adopt

requirements similar to 34.73 (b) for

information on the records to meet

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

4 N/A 34.81 1997-5 C Copies of operating and

emergency procedures

The State has omitted specific

guidance on maintaining and holding

copies of operating and emergency

procedures as required by 34.81.

The State needs to adopt the

requirements of 34.81 for the

maintenance of operating and

emergency procedures to meet

compatibility.

5 45.6 (9) 39.35 2000-1 C Leak testing of sealed sources

State omitted the exception for

neutron-emitters in 39.35(e)(5).

The State needs adopt the exception

for neutron-emitters in 39.35(e)(5) to

meet compatibility.

6 41.2 (74) 35.51 2002-2 B Training for an authorized medical

physicist

State omitted requirements for an

authorized medical physicist. The

requirements for a teletherapy

physicist are not adequate to cover

the requirements of 10 CFR 35.51.

The State needs to adopt the

essential requirements of 10 CFR

35.51 to meet compatibility.

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

byproduct material for which a

written directive is required

State omitted the training

requirements of Part 35.390.

The State needs to adopt the training

requirements of Part 35.390 to meet

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

8 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.

9 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)

State omitted the training

requirements of Part 35.394.

The State needs to adopt the training

requirements of Part 35.394 to meet

compatibility.

10 41.2 (73) 35.690 2002-2 B Training for use of remote

afterloader units, teletherapy units,

and gamma stereotactic

radiosurgery units

State does not fully meet the training

requirements of 10 CFR 35.690.

The State needs to adopt all the

training requirements of 10 CFR

35.690 to achieve compatibility.

11 41.2 (14) 35.3045 2002-2 C Report and notification of a

medical event

State has omitted essential elements

of Part 35.3045(a)(1-3) regarding

medical events that warrant reporting.

The State needs to include specific

guidance on reporting medical events

to meet all essential objectives of Part

35.3045. Particularly the State

should include the limits that trigger

reporting in 35.3045(a)(1-3).
STATE REGULATION STATUS

State: IOWA[Sixteen Amendments reviewed are identified by a  Tracking Ticket Number: at the beginning of each equivalent NRC regulation.] Date: SEPTEMBER 30

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

ML032230

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

ML

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

ML032230

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

ML032230

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

ML032230

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

ML032230

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

ML032230

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

ML032230

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

ML032230
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

ML032230

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

ML032230

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

ML032230

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

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

ML032230

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

ML032230

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

ML032230