June 27, 2007

Cindy Cardwell, Manager

Radiation Policy, Standards and Q/A Group

Department of State Health Services

1100 West 49th Street, MC 2828

Austin, TX 78756-3189

Dear Ms. Cardwell:

We have reviewed the proposed changes to the Texas regulations 289.202, 289.255, and

289.256 received by our office on May 16, 2007. These regulations were reviewed by

comparison to the equivalent Nuclear Regulatory Commission (NRC) rules in 10 CFR Parts 20,

32, 34, 35 and the requirements of the six amendments identified in the enclosed State

Regulation Status (SRS) Data Sheet. 

As a result of our review, we have four old comments which stand from previous letters and

nine new 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 Texas 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 Texas 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 Federal and State

Materials and Environmental Management Programs (FSME) Procedure SA-200.

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 FSME

Procedure SA-201, “Review of State Regulatory Requirements,” please highlight the final

changes, 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 Texas 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 FSME website: http://www.hsrd.ornl.gov/nrc/rulemaking.htm.
Cindy Cardwell, Manager -2- June 27, 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 Kathleen

Schneider, State Regulation Review Coordinator at (301) 415-2320 (email: kxs@nrc.gov) or

Monica Orendi at (301) 415-3938 (email: mlo1@nrc.gov).

Sincerely,

RA By D.White For\

Scott W. Moore, Deputy Director

Division of Materials Safety and State Agreements

Office of Federal and State Materials and

Environmental Management Programs

Enclosures:

 As stated
Cindy Cardwell, Manager -2- June 27, 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 Kathleen

Schneider, State Regulation Review Coordinator at (301) 415-2320 (email: kxs@nrc.gov) or

Monica Orendi at (301) 415-3938 (email: mlo1@nrc.gov).

Sincerely,

\RA By D.White For\

Scott W. Moore, 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 (7-42) SUNSI Review Complete

DCD (SP08) : Publicly Available G Non-Publicly Available

LMcLean, RSAO : Non-Sensitive G Sensitive

MOrendi [TX] File

DOCUMENT NAME: C:\FileNet\ML071790090.wpd

 ML of Incoming Document:ML071370165

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 SAISB SAISB SAISB OGC SAIS:BC MSSA:DD

NAME WRautzen MOrendi KSchneider FCameron DWhite SMoore

DATE 06/05/07* 06/05/07* 06/05/07* 06/21/07* 06/27/07* 06/27/07*

ML071790090 OFFICIAL RECORD COPY MLPKGML071790041
COMMENTS OUTSTANDING FROM PREVIOUS LETTERS SENT TO TEXAS

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

1 §289.257

(s)(5)(F)(v)

20 Appendix G.I.B5 1995-3 B Transfer for disposal and manifests

Appendix G only includes the radionuclide

activity of H-3, C-14, Tc-99, and I-129

contained in the shipment. However, in

Texas’ §289.257(s)(5)(F)(v), they include

not only the above elements, but also

chlorine-36, nickel-63, strontium-90,

cesium-137 and any other isotopes with a

half-life greater than 35 years.

Texas should eliminate chlorine-36,

nickel-63, strontium-90, cesium-137, and

other isotopes with a half-life greater than

35 years for the activity contained in the

shipment to meet the Compatibility

Category B designation assigned to 10

CFR 20 Appendix G.I.B5.

COMMENT STANDS: Texas did not

address this comment, from letter dated

October 21, 2005, during this rulemaking

and will need to address it in future

rulemakings.

2 289.201

(b)(94)

20.1003 2002-1 A Definitions: Shallow Dose Equivalent

(Hs)

Texas states “... external exposure of the

skin or an extremity...”. According to 10

CFR 20.1003 “... external exposure of the

skin of the whole body or the skin of an

extremity...” should be listed in the

definition of Shallow dose equivalent.

Texas needs to change its definition for

Shallow-dose equivalent in 289.201

(b)(94) to meet the Compatibility Category

A designation assigned to this definition in

10 CFR 20.1003.

COMMENT STANDS: Texas did not

address this comment, from a letter dated

November 21, 2006, during this

rulemaking and will need to address it in

future rulemakings.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

3 289.202(n) 20.1301(a)&(c) 2002-2 A Dose limits for individual members of

the public

 Texas regulations omit 10 CFR

20.1301(c) “...a licensee may permit

visitors to an individual who cannot be

released, under §35.75, to receive a

radiation dose greater than 0.1 rem (1

Mev) if ...”.

Texas needs to add the above section to

meet the Compatibility Category A

designation assigned to 10 CFR 20.1301.

COMMENT STANDS: Texas did not

address this comment, from a letter dated

November 21, 2006, during this

rulemaking and will need to address it in

future rulemakings.

4 289.252 (o) 32.74(a) 2002-2 B Manufacture and distribution of

sources or devices containing

byproduct material for medical use

 Texas omits 10 CFR 32.74(a)(2)(vii) from

its regulations. Also Texas adds a section

(289.252 (o)(1)(H)) which does not

appear in 10 CFR 32.74(a)

Texas needs to add section (a)(2)(vii) and

remove 289.252 (o)(1)(H) to meet the

Compatibility Category B designation

assigned to 10 CFR 32.74(a).

COMMENT STANDS: Texas did not

address this comment, from a letter dated

November 21, 2006, during this

rulemaking and will need to address it in

future rulemakings.
COMPATIBILITY COMMENTS ON TEXAS PROPOSED REGULATIONS

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

1 289.256

(c)(3)

35.2 2002-2

2006-1

B Definitions: Authorized medical

physicist

Texas adds an additional section

(289.256(c)(3)(C)) to their definition of

Authorized Medical Physicist. This

section makes this definition more

restrictive than NRC’s definition.

Texas needs to remove section (C) from

289.256(c)(3) Authorized Medical

Physicist to meet the Compatibility

Category B designation assigned to 10

CFR 35.2 Definition: Authorized Medical

Physicist.

2 289.256 (c)(4) 35.2 2002-2

2006-1

B Definitions: Authorized nuclear

pharmacist

Texas adds an additional section

(289.256(c)(4)(E)) to their definition of

Authorized Nuclear Pharmacist. This

section makes this definition more

restrictive than NRC’s definition.

Texas needs to remove section (E) from

289.256(c)(4) Authorized Nuclear

Pharmacist to meet the Compatibility

Category B designation assigned to 10

CFR 35.2 Definition: Authorized Nuclear

Pharmacist.

3 289.256(h) 35.50 2002-2

2005-2

2006-1

B Training for Radiation Safety Officer

Texas cites the wrong paragraph in

289.256(h)(5). Texas states: “... has

successfully completed the requirements

in paragraph (5)...”. Texas should state:

“... has successfully completed the

requirements in paragraph (6)...”.

Texas needs to change 289.256(h) to

reflect the above comment in order to

meet the Compatibility Category B

designation assigned to 10 CFR 35.50.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

4 289.256(k) 35.55 2002-2

2005-2

B Training for an authorized nuclear

pharmacist

Texas states in 289.256(k)(1) “... an

agreement state and who meets the

requirements of subparagraph (C) of this

paragraph.”. The statement should be

corrected to say “... an agreement state

and who meets the requirements of

subparagraph (2)(C) of this paragraph.”

since subparagraph (2)(C) is the correct

reference to NRC 10 CFR 35.55(b)(2).

Texas needs to make the above

correction in order to meet the

Compatibility Category B designation

assigned to 10 CFR 35.55.

5 289.256(qq) 35.396 2005-2

2006-1

B Training for the parenteral

administration of unsealed byproduct

material requiring a written directive.

Texas adds an “or” written at the end of

subsection 289.256(qq)(3). This should

be removed and replaced with a “.”.

Texas needs to remove the “or” written at

the end of subsection 289.256(qq)(3)

and replace it with a “.” in order to meet

the Compatibility Category B designation

assigned to 10 CFR 35.396.

6 N/A 20. Appendix B 2006-1 A Standards For Protection Against

Radiation “List of Elements”

Texas only addressed part 35 changes in

this rulemaking.

Texas will need to address this section in

a future rulemaking in order to meet the

Compatibility Category A designation

assigned to 10 CFR 20 Appendix B.

7 N/A 32.72 2006-1 B Manufacture, preparation, or

transfer for commercial distribution of

radioactive drugs containing

byproduct material for medical use

under part 35.

Texas only addressed part 35 changes in

this rulemaking.

Texas will need to address this section in

a future rulemaking in order to meet the

Compatibility Category A designation

assigned to 10 CFR 20 Appendix B.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

8 N/A 32.74 2006-1 B Manufacture and distribution of

sources or devices containing

byproduct material for medical use.

Texas only addressed part 35 changes in

this rulemaking.

Texas will need to address this section in

a future rulemaking in order to meet the

Compatibility Category A designation

assigned to 10 CFR 20 Appendix B.

9 289.202

(c)(39)

(hhh)(2)

20. Appendix E 2006-3 B Nationally tracked sources threshold

Texas lists the Promethium-147 Category

2 limit as 11,100.0 Ci instead of 11000 Ci,

and the Ytterbium-169 Category 1 limit as

8,1000 Ci instead of 8100 Ci. 

Texas needs to change these Category 1

and Category 2 limits to the proper

amounts to meet the Compatibility

Category B designation assigned to 10

CFR 20 Appendix E.
STATE REGULATION STATUS

State: Texas(6 Amendments reviewed identified by a i Trackinat the beginning of the equivalent NRC requirement.) Date: J

NRC Chronology Identification FR Notice

(State Due Date)

RATS ID Proposed (P) 

Final (F)1

Rule /LicenseCondition(LC) ML #5

NRC Review Y, N2 / Date /

ML #5

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

ML051520266

N 10/31/05ML053050013

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 N

11/6/97

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

ML052060129

N 9/29/05ML052720491

Quality Management Program and Misadministrations-Part 35 56 FR 34104; (1/27/95) 1992-1 Eliminating the Recordkeeping Requirements for Departures fromManufacturer's Instructions-Parts 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 F 

ML052060129

Y 9/29/05ML052720491

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

ML051520266

N 8/12/05ML052280032

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 F

ML062860025

N 11/21/06ML063200232

Uranium Mill Tailings Regulations: Conforming NRC Requirementsto EPA Standards-Part 40

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

(State Due Date)

RATS ID Proposed (P) 

Final (F)1Rule /LicenseCondition(LC) ML #5

NRC Review Y, N2 / Date /

ML #5

 Timeliness in Decommissioning Material Facilities-Parts 30, 40, 70 59 FR 36026; (8/15/97) 1994-3 F

ML052060129

N 9/29/05ML052720491

Preparation, Transfer for Commercial Distribution, and Use ofByproduct Material for Medical Use-Parts 30, 32, 35

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

1995-1 F N 3/17/99

 Frequency of Medical Examinations for Use of RespiratoryProtection Equipment-Part 20 

60 FR 7900; (3/13/98) 1995-2 F

ML051520266

N 10/31/05ML053050013

iLow-Level Waste Shipment Manifest Information and ReportingParts 20, 61 60 FR 15649; 60 FR 25983 (3/1/98) 1995-3 R9 ML071370165 Y 06/27/07 ML071790090 

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

ML051520266

N 10/31/05ML053050013

Radiation Protection Requirements: Amended Definitions andCriteria-Parts 19, 20 

60 FR 36038; (8/14/98) 1995-5 F N 3/17/99

 Clarification of Decommissioning Funding Requirements-Parts 30,40, 70

60 FR 38235; (11/24/98) 1995-6 F

ML052060129

N 9/29/05ML052720491

Medical Administration of Radiation and Radioactive Materials-Parts20, 35

60 FR 48623; (10/20/98) 1995-7 F

ML051520266

N 10/31/05ML053050013

 10 CFR Part 71: Compatibility with the International Atomic EnergyAgency-Part 71

60 FR 50248; 61 FR 28724(4/1/99)

1996-1 F

ML052060129

Y 9/29/05ML052720491

One Time Extension of Certain Byproduct, Source and SpecialNuclear Materials Licenses-Parts 30, 40, 70

61 FR 1109; (none) 1996-2 

Termination or Transfer of Licensed Activities: RecordkeepingRequirements-Parts 20, 30, 40, 61, 70

61 FR 24669; (6/17/99) 1996-3 F (Part 30)

ML062860025

N 11/21/06ML063200232

Resolution of Dual Regulation of Airborne Effluents of RadioactiveMaterials; Clean Air Act-Part 20

61 FR 65120; (1/9/00) 1997-1 F N 7/7/00 

Recognition of Agreement State Licenses in Areas Under ExclusiveFederal Jurisdiction Within an Agreement State-Part 150

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

ML063030232

N 11/27/06ML063200389

Criteria for the Release of Individuals Administered RadioactiveMaterial-Parts 20, 35

62 FR 4120; (5/29/00) 1997-3 F N 7/7/00 

Fissile Material Shipments and Exemptions-Part 71 62 FR 5907; (none) 1997-4 
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID Proposed (P) 

Final (F)1Rule /LicenseCondition(LC) ML #5

NRC Review Y, N2 / Date /

ML #5

Licenses for Industrial Radiography and Radiation SafetyRequirements for Industrial Radiography Operations-Parts 30, 34,71, 150

62 FR 28947; (6/27/00) 1997-5 F N 7/7/00 

Radiological Criteria for License Termination-Parts 20, 30, 40, 70 62 FR 39057; (8/20/00) 1997-6 F N 7/7/00  Exempt Distribution of a Radioactive Drug Containing OneMicrocurie of Carbon-14 Urea-Part 30 

62 FR 63634; (1/02/01) 1997-7 F

ML052060129

N 9/29/05ML052720491

Deliberate Misconduct by Unlicensed Persons-Parts 30, 40, 61, 70,71, 150

63 FR 1890; 63 FR 13773(2/12/01)

1998-1 F

ML063030232

N 11/27/06ML063200389

Self-Guarantee of Decommissioning Funding by Nonprofit and NonBond-Issuing Licensees- Parts 30, 40, 70 63 FR 29535; (none) 1998-2 

License Term for Medical Use Licenses-Part 35 63 FR 31604; (none) 1998-3 iLicenses for Industrial Radiography and Radiation SafetyRequirements for Industrial Radiographic Operations-Part 34

63 FR 37059; (7/9/01) 1998-4 R9

ML071370165

N 6/27/07ML071790090

Minor Corrections, Clarifying Changes, and a Minor Policy ChangeParts 20, 35, 36 63 FR 39477; 63 FR 45393 (10/26/01) 1998-5 F N 7/7/00 Transfer for Disposal and Manifests: Minor Technical ConformingAmendment-Part 20

63 FR 50127; (11/20/01) 1998-6 F N 7/7/00 

Radiological Criteria for License Termination of Uranium RecoveryFacilities-Part 40

64 FR 17506; (6/11/02) 1999-1 F

ML051520266

Y 8/12/05ML052280032

Requirements for Those Who Possess Certain Industrial DevicesContaining Byproduct Material to Provide Requested InformationPart 31

64 FR 42269; (none) 1999-2 

Respiratory Protection and Controls to Restrict Internal ExposurePart 20 64 FR 54543; 64 FR 55524 (2/2/03) 1999-3 FML062750348 N 11/21/06 ML063200232 
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID Proposed (P) 

Final (F)1Rule /LicenseCondition(LC) ML #5

NRC Review Y, N2 / Date /

ML #5

Energy Compensation Sources for Well Logging and OtherRegulatory Clarifications-Part 39

65 FR 20337; (5/17/03) 2000-1 F

ML051520266

N 11/30/06ML063340007

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

ML051520266

N 8/12/05ML052280032

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

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

ML051520266

Y 8/31/2006ML062410004

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

ML062750348

Y 11/21/06ML063200232

iMedical Use of Byproduct Material-Parts 20, 32, and 35 67 FR 20249; (10/24/05) 2002-2 R9

ML071370165

Y 6/27/07ML071790090

Financial Assurance for Materials Licensees – Parts 30, 40, 70 68 FR 57327; (12/3/06) 2003-1Compatibility with IAEA Transportation Safety Standards and OtherTransportation Safety Amendments - Part 71

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

Security Requirements for Portable Gauges Containing ByproductMaterial - Part 30

70 FR 2001; (7/11/08) 2005-1

iMedical Use of Byproduct Material - Recognition of SpecialtyBoards - Part 35

70 FR 16336; 71 FR 1926(4/29/08)

2005-2 P

ML071370165

Y 6/27/07ML071790090

Increased Controls for Risk-Significant Radioactive Sources (NRCOrder EA-05-090)6

70 FR 72128; (12/1/05) 2005-3 LC

ML052240226

N 12/12/05ML053420404

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

ML071370165

Y 6/27/07ML071790090 

National Source Tracking System - Serialization Requirements - Part32 with reference to Part 20 Appendix E

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

ML070100405

N 01/22/07ML070240176
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID Proposed (P) 

Final (F)1Rule /LicenseCondition(LC) ML #5

NRC Review Y, N2 / Date /

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 Number6. By letter dated September 2, 2005, from Paul H. Lohaus, Director, Office of State and Tribal Programs, Agreement States were given 90 day

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

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

STP 05-072.

8. 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.

9. R stands for proposed changes made to final regulations.

iNational Source Tracking System - Part 208 71 FR 65865 (11/15/07) &

(11/30/07)

2006-3 P

ML071370165

Y 6/27/07ML071790090