August 18, 2005

Ronnie Wascom, Administrator

Emergency and Radiological Services Division

Department of Environmental Quality

602 N. 5th, P.O. Box 4313

Baton Rouge, LA 70821-4313

Dear Mr. Wascom:

We have reviewed the proposed changes to the Louisiana Administrative Code, Title 33, Part

XV, Radiation Protection, RP0034, RP0035, RP0036, RP0037, and RP0038, received by our

office on April 11, 2005. These regulations were reviewed by comparison to the equivalent

Nuclear Regulatory Commission (NRC) rules in 10 CFR Parts 20, 30, 31, 32, 35 and 36 and the

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

Data Sheet. We discussed our review of the regulations with Sharon Parker on May 26, 2005.

As a result of our review, we have five 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 Louisiana 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 Louisiana 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.

In addition, we reviewed the corrections to Louisiana Administrative Code, Title 33, Part XV,

Radiation Protection, resulting from the NRC letters dated August 26, 2004, June 3, 2004, and

July 31, 2003, as listed in the addendum to your April 11, 2005 letter. All of the changes noted

in this addendum resolve our comments and these are closed. However we note that you

indicated that the rest of the NRC comments, as listed in the addendum, will be addressed in a

future rulemaking. In order to track the comments that still need to be addressed and for ease

of future review, we have attached them to this letter.

As noted in the enclosure, two comments address Louisiana proposed regulations for generally

licensed devices. Please note that we have a Petition For Rulemaking from the Organization of

Agreement States (OAS) currently under review by NRC staff, and a request from OAS and the

State of Florida to change the Compatibility Category assigned to sections of the GL rule. Staff

is examining whether there may be need for additional guidance to Agreement States regarding

the status of some Agreement State GL rules during the interim time the NRC will require to

complete action on the Petition and request. We will correspond separately with you on this

issue in the near future.

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.
Mr. Ronnie Wascom -2- August 18, 2005

The SRS Data Sheet summarizes our knowledge of the status of other Louisiana 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 John Zabko

at (301) 415-2308 or by e-mail at JGZ@NRC.GOV.

Sincerely,

\RA By K.N.Schneider For\

 Dennis Rathbun, Deputy Director

 Office of State and Tribal Programs

Enclosures: 

As stated
Mr. Ronnie Wascom -2- August 18, 2005

The SRS Data Sheet summarizes our knowledge of the status of other Louisiana 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 John Zabko

at (301) 415-2308 or by e-mail at JGZ@NRC.GOV.

Sincerely,

 \RA By K.N.Schneider For\

 Dennis Rathbun, Deputy Director

 Office of State and Tribal Programs

Enclosures: 

As stated

SISP Review Complete 

: Publicly Available G Non-Publicly Available

: Non-Sensitive G Sensitive

Distribution:

DIR RF [5-115) DCD (SP08) PDR (YES_T)

LMcLean, RSAO, Kschneider, ASPO, BUSilton, Louisiana file Response to Incoming Document: ML051080512

DOCUMENT NAME:E:\Filenet\ML052310429.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 JZabko WRautzen STreby DRathbun

DATE 07/18/05* 07/19/05 * 08/15/05 * 08/18/05*

ML OFFICIAL RECORD COPY
COMMENTS ON PROPOSED LOUISIANA REGULATIONS

AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES 

STATE SECTION NRC

Section

RATS ID CATEGORY SUBJECT and COMMENTS

1 322 (D) (3)(d) 31.5(c)

(4) 

2001-1 B Certain detecting, measuring, gauging,

or controlling devices and certain

devices for producing light or an ionized

atmosphere

Louisiana has different record retention

requirements for tests of the on-off

mechanisms in section 322 (D) (3)(d). 

Section 10 CFR 31.5(c)(4) requires a three

year retention. 

Louisiana needs to adopt a three year

record retention time to meet the

Compatibility Category B designation

assigned to Section 10 CFR 31.5(c)(4). 

2 322 (D) (3)(h) 31.5(c)

(9)(ii)

2001-1 B Certain detecting, measuring, gauging,

or controlling devices and certain

devices for producing light or an ionized

atmosphere

Louisiana omitted the term “intermediate

person” as added by this amendment.

Louisiana needs to add the term

“intermediate person” to to meet the

Compatibility Category B designation

assigned to Section 31.5(c)(9)(ii).

3 Title 33, Part

XV§ 723

35.69 2002-2 H&S Labeling of Vials and Syringes

Louisiana does not cover all of the required

elements of this section.

Louisiana needs to adopt the essential

objectives of the requirements for labeling

of vials and syringes to meet the Category

H&S designation assigned to Section 10

CFR 35.69.
STATE SECTION NRC

Section

RATS ID CATEGORY SUBJECT and COMMENTS

4 Title 33, Part

XV§ 728

35.92 2002-2 H&S Decay in Storage

Louisiana does not limit the type of

radioactive material that can be stored for

decay as in 10CFR 35.92. Louisiana does

not use the 120 day half life limit.

Louisiana needs to adopt the essential

objectives of the requirements for decay in

storage to meet the Category H&S

designation assigned to Section 10 CFR

35.92

5 None 35.400 2002-2 C Use of sealed sources for manual

brachytherapy

Louisiana omitted Section 10 CFR 35.400. 

Louisiana needs to adopt Section 10 CFR

35.400 to meet the Compatibility Category

C designation assigned to Section 10 CFR

35.400.
COMMENTS THAT REMAIN FROM PAST NRC LETTERS 

DATED JULY 31, 2003, JUNE 3 2004 AND AUGUST 26 2004.

STATE

SECTION

NRC

Section

RATS

ID

CATEGORY SUBJECT and COMMENTS STATE RESPONSE

TO COMMENTS

1 442.A.

4.d &

442.A.

4.e

20.1703

(f)

1999-3 H&S USE OF INDIVIDUAL

RESPIRATORY PROTECTION

Louisiana defines the minimum

respiratory protection program

expected of any licensee who

assigns or permits the use of

respirators to limit intake. Louisiana

organization placed these

provisions under the requirements

for a written policy statement which

does not achieve the same

objective.

Louisiana needs to adopt the

essential objectives of the

requirements for the licensee prior

to assigning or permitting the use of

respirators and not just a

requirement for a written policy

statement to meet the Category

H&S designation assigned to

Section 10 CFR 20.1703 (f).

Louisiana will

address this

comment in future

rulemaking.
STATE

SECTION

NRC

Section

RATS

ID

CATEGORY SUBJECT and COMMENTS STATE RESPONSE

TO COMMENTS

2 421 20.1301

(a) & (c)

2002-2 A Dose limits for individual

members of the public

Louisiana Section 421.B allows

access to be granted to members of

the public to restricted areas. NRC

Section 10 CFR 20.1301 states that

access can only be granted to

controlled areas. The words

controlled and restricted cannot be

used interchangeably. They are

defined as two separate areas.

Louisiana needs to change the

wording of Section 421.B to reflect

the difference between the

controlled area and the restricted

area to meet the Compatibility

Category A designation assigned to

Section 10 CFR 20.1003.

This comment will

be corrected in

future rulemaking.

3 421 20.1301

(a) & (c)

2002-2 A Dose limits for individual

members of the public

Louisiana omitted requirements of

paragraph (c) of Part 20.1301 for

members of the public visiting a

person that cannot be released

under 35.75 or equivalent

Agreement State regulations.

Louisiana needs to adopt

requirements of paragraph (c) of

Part 20.1301 to meet the

Compatibility Category A

designation assigned to Section 10

CFR 20.1003.

This comment will

be corrected in

future rulemaking.
STATE

SECTION

NRC

Section

RATS

ID

CATEGORY SUBJECT and COMMENTS STATE RESPONSE

TO COMMENTS

4 102 35.2 2002-2 B Definition: Authorized medical

physicist

Louisiana omitted the requirements

of paragraph (1) of the definition of

authorized medical physicist in 10

CFR 35.2, which defines the

training and experience required for

an authorized medical physicist.

Louisiana needs to add a reference

to the required training and

experience for an authorized

medical physicist to meet the

Compatibility Category B

designation assigned to this

definition in Section 10 CFR 35.2.

This comment will

be corrected in

future rulemaking.

This is part of

amendment

2005-2,

Agreement

States have until

April 29, 2008 to

adopt these

requirements

5 102 35.2 2002-2 B Definition: Authorized nuclear

pharmacist

Louisiana omitted the requirements

of paragraph (1) of the definition of

authorized nuclear pharmacist in

Part 35.2, which defines the training

and experience required for an

authorized nuclear pharmacist.

Louisiana needs to add a reference

to the required training and

experience for an authorized

nuclear pharmacist to meet the

Compatibility Category B

designation assigned to this

definition in Section 10 CFR 35.2.

This comment will

be corrected in

future rulemaking.

This is part of

amendment

2005-2,

Agreement

States have until

April 29, 2008 to

adopt these

requirements
STATE

SECTION

NRC

Section

RATS

ID

CATEGORY SUBJECT and COMMENTS STATE RESPONSE

TO COMMENTS

6 102 35.2 2002-2 B Definition: Authorized user

Louisiana omitted the requirements

of paragraph (1) of the definition of

authorized user in Part 35.2, which

defines the training and experience

required for an authorized user.

Louisiana needs to add a reference

to the required training and

experience for an authorized user to

meet the Compatibility Category B

designation assigned to this

definition in Section 10 CFR 35.2.

This comment will

be corrected in

future rulemaking.

This is part of

amendment

2005-2,

Agreement

States have until

April 29, 2008 to

adopt these

requirements

7 102 35.2 2002-2 B Definition: Radiation Safety

Officer

Louisiana definition does not

mention that the Radiation Safety

Officer is required to be listed on

the license as is found in the

definition in Part 35.2.

Louisiana needs to add language to

the current definition to reflect that

the radiation safety officer must be

listed on the license to meet the 

Compatibility Category B

designation assigned to this

definition in Section 10 CFR 35.2.

This comment will

be corrected in

future rulemaking.
STATE

SECTION

NRC

Section

RATS

ID

CATEGORY SUBJECT and COMMENTS STATE RESPONSE

TO COMMENTS

8 102 35.2 2002-2 B Definition: Sealed Source

Louisiana definition refers to a

sealed source as any container of

radioactive material constructed to

prevent escape of material. The

definition in 10 CFR 35.2 uses

language that ensures the source is

encased to prevent leakage and

escape of material.

Louisiana should revise their

current definition to define that the

source should be encased or

encapsulated to prevent leakage or

escape of material to meet the 

Compatibility Category B

designation assigned to this

definition in Section 10 CFR 35.2..

This comment will

be corrected in

future rulemaking.

9 703 35.6 2002-2 C Provisions for the protection of

human research subjects

Louisiana omitted the requirements

of 10 CFR 35.6(b)(1) and (2) that

require the licensee to obtain

approval from an “Institutional

Review Board” and the subject’s

“informed consent” prior to

conducting federally conducted,

funded, supported or regulated

research activities.

Louisiana needs to adopt the

requirements requiring Institutional

Review Board approval and patient

informed consent research activities

to meet the Compatibility Category

C designation assigned to Section

10 CFR 35.6 

This comment will

be corrected in

future rulemaking.
STATE

SECTION

NRC

Section

RATS

ID

CATEGORY SUBJECT and COMMENTS STATE RESPONSE

TO COMMENTS

10 706

707

35.24 2002-2 D –

paragraphs

(a)(1),

(a)(2),

(a)(3), (c),

(d), (e), (g),

and (h)

H & Sparagraph

(b) and (f)

Authority and responsibilities for

the radiation protection program

Louisiana regulations do not require

the radiation safety officer to agree

in writing to assuming responsibility

of the licensee’s radiation protection

program. The lack of this

requirement may cause liability

issues in the event of a violation or

accident.

Louisiana needs to add language to

ensure that each licensee requires

the radiation safety officer to

assume responsibility of the

radiation protection program in

writing to meet the Category H&S

designation assigned to Section 10

CFR 35.24.

This comment will

be corrected in

future rulemaking.

11 763.O 35.59 2002-2 B Recentness of training

Louisiana requires training and

experience to be acquired within

five years of application. NRC

regulations allow training to be

acquired within seven years of

application. Louisiana’s regulations

are more restrictive than those of

the NRC. This could potentially

have transboundary implications.

Louisiana needs to adopt the

requirements of Part 35,59 to meet

compatibility.

This comment will

be considered in

future rulemaking.
STATE

SECTION

NRC

Section

RATS

ID

CATEGORY SUBJECT and COMMENTS STATE RESPONSE

TO COMMENTS

12 736

737

742

743

35.310

35.315

35.410

35.415

2002-2 H & S Safety instruction/Safety

precautions

Louisiana requires the radiation

safety officer or the authorized user

to be contacted in the event of the

patient’s or human research

subject’s death or medical

emergency. NRC regulations

require both the radiation safety

officer or his/her designee and the

authorized user to be contacted in

the event of a death or medical

emergency.

Louisiana needs to change the

language of their equivalent rule to

ensure both the radiation safety

officer or designee and the

authorized user are contacted.

This comment will

be corrected in

future rulemaking.

13 755 35.630 2002-2 H & S,

except

paragraph

(c) is D

Dosimetry equipment

Louisiana’s requirements for

intercomparing dosimetry systems

to be used for calibrating sealed

sources for therapeutic units do not

require the licensee to use a

comparable unit in reference to

beam attenuators or collimators, as

applicable, but does require the

radionuclide to be the same as the

source used at the licensee’s

facility.

Louisiana needs to add additional

language regarding the similarities

in beam attenuators and collimators

between units as found in 10 CFR

35.630(a)(2) to meet compatibility.

This comment will

be corrected in

future rulemaking.
STATE

SECTION

NRC

Section

RATS

ID

CATEGORY SUBJECT and COMMENTS STATE RESPONSE

TO COMMENTS

14 757.A

759

35.642 2002-2 H & S,

except

paragraph

(f) is D.

Periodic spot-checks for

teletherapy units

In Paragraph A.2.a of §757,

Louisiana uses the term

“constancy” instead of “accuracy.”

This may be an editorial error since

similar language in other sections is

correct; however, the error will

cause compatibility issues.

This comment will

be corrected in

future rulemaking.

15 757.A

759

35.642 2002-2 H & S,

except

paragraph

(f) is D.

Periodic spot-checks for

teletherapy units

In Paragraph A.7.d of §757,

Louisiana does not require the

intercom system to be inspected

during the safety-spot check. This

may be an editorial error since

similar language in other sections is

correct; however, the error will

cause compatibility issues.

In Paragraph A.7.d of §757,

Louisiana needs to add “intercom

system” to the items inspected

during the safety-spot check to

meet compatibility.

This comment will

be corrected in

future rulemaking.
STATE REGULATION STATUS

State: Louisiana[Three amendments reviewed are identified by a i Tracking Ticket Number: 5-115

at the beginning of each equivalent NRC regulation.] Date: August 18, 2005

NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed Final (F)1 

/ ML #5

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 FR57877;58 FR 67657; 59 FR41641;60 FR 20183; (1/1/94)

1991-3 P 

Notification of Incidents-Parts 20, 30, 31, 34, 39, 40, 70 56 FR 64980; (10/15/94) 1991-4 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 Decommissioning Recordkeeping and License Termination: Documentation Additions[Restricted areas and spill sites]-Parts 30, 40 

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

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 P 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 Standards-Part 40 59 FR 28220; (7/1/97) 1994-2 
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed Final (F)1 

/ ML #5

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 for MedicalUse-Parts 30, 32, 35

59 FR 61767; 59 FR65243;60 FR 322; (1/1/98)

1995-1 F 

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 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

ML0202802

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 P 

Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air ActPart 20 61 FR 65120; (1/9/00) 1997-1 FML0115103Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Withinan Agreement State-Part 150

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

ML0115103

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

ML0202802

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

(State Due Date)

RATS ID

Proposed Final (F)1 

/ ML #5

ML0115103

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

ML0115103

Self-Guarantee of Decommissioning Funding by Nonprofit and Non-Bond-Issuing LicenseesParts 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 P

ML010460

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

45393;(10/26/01)

1998-5 F

ML0115103

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

ML0418803

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

ML0418803

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

ML0418803

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

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

ML0510805

iRevision of the Skin Dose Limit-Part 20 67 FR 16298; (4/5/05) 2002-1 P ML05108

i Medical Use of Byproduct Material-Parts 20, 32, and 35 67 FR 20249;(10/24/05) 2002-2 P ML05108
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed Final (F)1 

/ ML #5

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 Polic

Adequacy and Compatibility of Agreement State Programs,” III.1. Time Frame for Adoption of Compatible State Regulations, p. 6, 1995.

5. ADAMS ML Number

Compatibility 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) 2005-1Medical Use of Byproduct Material - Recognition of Specialty Boards - Part 35 70 FR 16336; (4/29/08) 2005-2