June 3, 2004

Ms. Barbara Romanowsky, Administrator

Office of Environmental Assessment

Louisiana Department of Environmental Quality

P.O. Box 4314

Baton Rouge, LA 70821

Dear Ms. Romanowsky: 

We have reviewed the proposed regulation amendments to the Louisiana Administrative Code,

Title 33, Part XV, Radiation Protection, RP036, received by our office on May 4, 2004. Our

review and comments are in response to the State’s request for Nuclear Regulatory

Commission (NRC) evaluation of the changes to Louisiana Administrative Code that

incorporated the amendments identified on the State Regulation Status Data Sheet (SRS). 

These regulations were reviewed by comparison to the equivalent Nuclear Regulatory

Commission (NRC) regulations in 10 CFR Part 20, 32, and 35 and the requirements of the one

amendment identified in the enclosed SRS. We discussed our review of the regulations with

Sharon Parker on June 3, 2004.

As a result of our review, we have fifteen comments. Under our current procedure, a finding

that a State regulation meets the compatibility and health and safety categories of the

equivalent NRC regulation may only be made based on a review of the final State regulation. 

Please provide a final amended version of your rules showing the location of any changes

made in response to our comments. If there are any comments which Louisiana 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, but 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, “Compatibility Categories and Health and Safety

Identification for NRC Regulations and Other Program Elements.” (STP-02-075)

We have also identified a number of issues related to training and experience requirements of

persons conducting activities under 10 CFR Part 35, “Medical Use of Byproduct Material.” We

understand that these items will be resolved at a later date when the NRC rulemaking, in 10

CFR Part 35 related to training and experience, is completed and Louisiana revises that part of

its regulations containing these requirements. We have included them in a separate chart for

your convenience, and no action on these items is required at this time.

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.
Ms. Barbara Romanowsky -2- June 3, 2004

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 K.N.Schneider For\

Josephine Piccone, Deputy Director

Office of State and Tribal Programs

Enclosures:

As stated
Ms. Barbara Romanowsky -2- June 3, 2004

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 K.N.Schneider For\

Josephine Piccone, Deputy Director

Office of State and Tribal Programs

Enclosures:

As stated

Enclosures: 

As stated

Distribution:

DIR RF [ 4-107 ] DCD (SP08) Linda McLean RSAO K. Schneider ASPO

PDR (YES_) BUsilton Louisiana File Response to Incoming Document: ML041250500

DOCUMENT NAME:C:\ORPCheckout\FileNET\ML041590013.wpd Response to

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 KNS for JMPiccone

DATE 05/13/04* 05/13/04* 06/03/04* 06/03/04*

ML041590013 OFFICIAL COPY
EDITORIAL SUGGESTIONS

1. In §756.B.4, change the reference to “Subsection A of this Section” to “Subsection B” to

correctly reflect the intention of the paragraph.

2. In Paragraphs 4 and 5 of §757.A replace all instances of “teletherapy physicist” with

“authorized medical physicist” to reflect trade-accepted language.
COMMENTS ON PROPOSED LOUISIANA REGULATIONS

AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

1 421 20.1301 (a) and (c) 2002-2 A Dose limits for individual members of

the public.

421.B allows access to be granted to

members of the public to restricted areas. 

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.

The State should change the wording of

421.B to reflect the difference between

the controlled area and the restricted

area.

2 421 20.1301 (a) and (c) 2002-2 A Dose limits for individual members of

the public.

State omits 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.

The State needs to adopt regulations

regarding the dose to individual members

of the public received from patients

released under Part 35.75 or equivalent

regulations to meet compatibility.

3 102 35.2 2002-2 B Definition: Authorized medical

physicist.

State omits the requirements of

paragraph (1) of the definition of

authorized medical physicist in Part 35.2,

which defines the training and

experience required for an authorized

medical physicist.

The State needs to add a reference to

the required training and experience for

an authorized medical physicist to meet

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

4 102 35.2 2002-2 B Definition: Authorized nuclear

pharmacist.

State omits 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.

The State needs to add a reference to

the required training and experience for

an authorized nuclear pharmacist to meet

compatibility.

5 102 35.2 2002-2 B Definition: Authorized user.

State omits 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.

The State needs to add a reference to

the required training and experience for

an authorized user to meet compatibility.

6 102 35.2 2002-2 B Definition: Radiation Safety Officer.

State omits the requirements of

paragraph (1) of the definition of radiation

safety officer in Part 35.2, which defines

the training and experience required for a

radiation safety officer.

The State needs to add a reference to

the required training and experience for a

radiation safety officer to meet

compatibility.

7 102 35.2 2002-2 B Definition: Radiation Safety Officer.

The State 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.

The State should add language to the

current definition to reflect that the

radiation safety officer must be listed on

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

8 102 35.2 2002-2 B Definition: Sealed Source.

The State definition refers to a sealed

source as any container of radioactive

material constructed to prevent escape of

material. This definition may be

confusing or misleading. Part 35.2 uses

language that ensures the source is

encased to prevent leakage and escape

of material.

The State should revise their current

definition to define that the source should

be encased or encapsulated to prevent

leakage or escape of material to provide

clarity.

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

research subjects

The State has omitted the requirements

of Part 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.

The State needs to adopt the

requirements of Part 35.6 requiring

Institutional Review Board approval and

patient informed consent for the research

activities listed above.

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

The State’s 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.

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

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

The State requires training and

experience to be acquired within five

years of application. NRC regulations

allow training to be acquired within seven

years of application. The State’s

regulations are more restrictive than

those of the NRC. This could potentially

have transboundary implications.

The State needs to adopt the

requirements of Part 35.59 to meet

compatibility.

12 736

737

742

743

35.310

35.315

35.410

35.415

2002-2 H&S Safety instruction/Safety precautions

The State 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.

The State needs to change the language

of their equivalent rule to ensure both the

radiation safety officer or designee and

the authorized user are contacted.

13 755 35.630 2002-2 H&S, except

paragraph (c)

is D

Dosimetry equipment

The State’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.

The State 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.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and 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, the State

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. 

In Paragraph A.2.a of §757, the State

needs to replace “constancy” with

“accuracy” to meet compatibility.

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, the State

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, the State

needs to add “intercom system” to the

items inspected during the safety-spot

check to meet compatibility.
COMMENTS ON PROPOSED LOUISIANA REGULATIONS AGAINST COMPATIBILITY AND

HEALTH AND SAFETY CATEGORIES FOR TRAINING REQUIREMENTS FOR MEDICAL

LICENSEES

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

1 763 35.50 2002-2 B Training for Radiation Safety Officer

The State has retained part of the previous

Part 35 training requirements; however, in its

letter transmitting this amendment, the State

noted that it will amend training requirements

for Radiation Safety Officers upon completion

of NRC’s current 10 CFR 35 rulemaking

regarding training requirements for physician

authorized users.

The State should revise this requirement

when the NRC rulemaking for Part 35 on

training is completed.

2 763 35.51 2002-2 B Training for an Authorized Medical

Physicist

The State has retained part of the previous

Part 35 training requirements; however, in its

letter transmitting this amendment, the State

noted that it will amend training requirements

for an authorized medical physicist on 

completion of NRC’s current 10 CFR 35

rulemaking regarding pertinent training

requirements.

The State should revise this requirement

when the NRC rulemaking for Part 35 on

training is completed.

3 763 35.55 2002-2 B Training for an authorized nuclear

pharmacist

The State has retained part of the previous

Part 35 training requirements; however, in its

letter transmitting this amendment, the State

noted that it will amend training requirements

for an authorized nuclear pharmacist upon

completion of NRC’s current 10 CFR 35

rulemaking regarding pertinent training

requirements.

The State should revise this requirement

when the NRC rulemaking for Part 35 on

training is completed.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

4 763 35.57 2002-2 B Training for experienced Radiation Safety

Officer, teletherapy or medical physicist,

authorized user, and nuclear pharmacist

The State has retained part of the previous

Part 35 training requirements; however, in its

letter transmitting this amendment noted that

it will amend training requirements for 

experienced Radiation Safety Officer,

teletherapy or medical physicist, authorized

user, and nuclear pharmacist upon

completion of NRC’s current 10 CFR 35

rulemaking regarding pertinent training

requirements.

The State should revise these requirements

when the NRC rulemaking for Part 35 on

training is completed.

5 763 35.190 2002-2 B Training for uptake, dilution and excretion

studies

The State has retained part of the previous

Part 35 training requirements; however, its

letter transmitting this amendment noted that

it will amend training requirements for uptake,

dilution and excretion studies upon completion

of NRC’s current 10 CFR 35 rulemaking

regarding pertinent training requirements.

The State should revise these requirements

when the NRC rulemaking for Part 35 on

training is completed.

6 763 35.290 2002-2 B Training for imaging and localization

studies

The State has retained part of the previous

Part 35 training requirements; however, its

letter transmitting this amendment noted that

it will amend training requirements for 

imaging and localization studies upon

completion of NRC’s current 10 CFR 35

rulemaking regarding pertinent training

requirements.

The State should revise these requirements

when the NRC rulemaking for Part 35 on

training is completed.

7 763 35.390 2002-2 B Training for use of unsealed byproduct

material for which a written directive is

required

The State has retained part of the previous

Part 35 training requirements; however, its

letter transmitting this amendment noted that

it will amend training requirements for use of

unsealed byproduct material for which a

written directive is required upon completion

of NRC’s current 10 CFR 35 rulemaking

regarding pertinent training requirements.

The State should revise these requirements

when the NRC rulemaking for Part 35 on

training is completed.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

8 763 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 microcuries)

The State does not have regulations for the 

the oral administration of sodium iodide I-131

requiring a written directive in quantities less

than or equal to 1.22 Gigabecquerels (33

microcuries). In its letter transmitting this

amendment, the State noted that it will amend

training requirements upon completion of

NRC’s current 10 CFR 35 rulemaking

regarding pertinent training requirements.

The State should include regulations

addressing this NRC requirement when the

NRC rulemaking for Part 35 on training is

completed.

9 763 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 microcuries)

The State does not have regulations for the 

the oral administration of sodium iodide I-131

requiring a written directive in quantities

greater than 1.22 Gigabecquerels (33

microcuries). In its letter transmitting this

amendment, the State noted that it will amend

training requirements upon completion of

NRC’s current 10 CFR 35 rulemaking

regarding pertinent training requirements.

The State should include regulations

addressing this NRC requirement when the

NRC rulemaking for Part 35 on training is

completed.

10 763 35.490 2002-2 B Training for use of manual brachytherapy

sources

The State has retained part of the previous

Part 35 training requirements; however, in its

letter transmitting this amendment the State

noted that it will amend training requirements

for use of manual brachytherapy sources

upon completion of NRC’s current 10 CFR 35

rulemaking regarding pertinent training

requirements.

The State should revise these requirements

when the NRC rulemaking for Part 35 on

training is completed.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

11 763 35.491 2002-2 B Training for ophthalmic use of strontium90

The State has retained part of the previous

Part 35 training requirements; however, its

letter transmitting this amendment noted that

it will amend training requirements for 

ophthalmic use of strontium-90 upon

completion of NRC’s current 10 CFR 35

rulemaking regarding pertinent training

requirements.

The State should revise these requirements

when the NRC rulemaking for Part 35 on

training is completed.

12 763 35.590 2002-2 B Training for use of sealed sources for

diagnosis

The State has retained part of the previous

Part 35 training requirements; however, its

letter transmitting this amendment noted that

it will amend training requirements for use of

sealed sources for diagnosis upon completion

of NRC’s current 10 CFR 35 rulemaking

regarding pertinent training requirements.

The State should revise these requirements

when the NRC rulemaking for Part 35 on

training is completed.

13 763 35.690 2002-2 B Training for use of remote afterloader

units, teletherapy units, and gamma

stereotactic radiosurgery units.

The State has retained part of the previous

Part 35 training requirements; however, its

letter transmitting this amendment noted that

it will amend training requirements for use of

remote afterloader units, teletherapy units,

and gamma stereotactic radiosurgery units

upon completion of NRC’s current 10 CFR 35

rulemaking regarding pertinent training

requirements.

The State should revise these requirements

when the NRC rulemaking for Part 35 on

training is completed.
STATE REGULATION STATUS

State: Louisiana[One amendment reviewed is identified by a  Tracking Ticket Number: 4-

at the beginning of each equivalent NRC regulation.] Date: June 3, 2004

NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Propose(P) / Fina(F)1 Rule 

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 FR 57877;58 FR 67657; 59 FR 41641;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 

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 FR 65243;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 
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Propose(P) / Fina(F)1 Rule 

ML #5

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

ML020280

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 FML011510

Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Withinan Agreement State-Part 150

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

ML011510

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

ML020280

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

ML011510

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

ML011510

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

ML011510
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Propose(P) / Fina(F)1 Rule 

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 

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

1995.

5. ADAMS ML Number

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 P

ML022280

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

ML031760

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

ML031760

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

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

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

ML040900

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

ML041250

Financial Assurance for Materials Licensees 

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