November 21, 2006

Cindy Cardwell, Manager

Radiation Policy, Standards and Q/A Group

Department of State Health Services

Division for Regulatory Services

1100 West 49th Street, MC 2828

Austin, TX 78756-3189

Dear Ms. Cardwell:

We have reviewed the final revision to the Texas regulations, 25 TAC 289.202 and 289.256,

received by our office on October 6, 2006 and October 10, 2006. These regulations were

reviewed by comparison to the equivalent Nuclear Regulatory Commission (NRC) rules in 10

CFR Parts 20, 30, 32, 35, 40, 61, and 70 and the requirements of the five amendments

identified in the enclosed State Regulation Status (SRS) Data Sheet. We discussed our review

of the regulations with you on November 13, 2006.

As a result of our review, we have 24 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. We have determined that if these regulations are revised, 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.

We request that when you revise your regulations to address our comments, 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 location of any changes made

by Texas, in response to our comments, and provide a copy to Division of Materials Safety and

State Agreements, Office of Federal and State Materials and Environmental Management

Programs (FSME) (see letter FSME 06-94 dated October 6, 2006 for further information).

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. 

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 (e-mail: kxs@nrc.gov), or

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

Sincerely,

\RA By S.W. Moore\

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
November 21, 2006

Cindy Cardwell, Manager

Radiation Policy, Standards and Q/A Group

Department of State Health Services/Division for Regulatory Services

1100 West 49th Street, MC 2828

Austin, TX 78756-3189

Dear Ms. Cardwell:

We have reviewed the final revision to the Texas regulations, 25 TAC 289.202 and 289.256,

received by our office on October 6, 2006 and October 10, 2006. These regulations were

reviewed by comparison to the equivalent Nuclear Regulatory Commission (NRC) rules in 10

CFR Parts 20, 30, 32, 35, 40, 61, and 70 and the requirements of the five amendments

identified in the enclosed State Regulation Status (SRS) Data Sheet. We discussed our review

of the regulations with you on November 13, 2006.

As a result of our review, we have 24 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. We have determined that if these regulations are revised, 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.

We request that when you revise your regulations to address our comments, 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 location of any changes made

by Texas, in response to our comments, and provide a copy to Division of Materials Safety and

State Agreements, Office of Federal and State Materials and Environmental Management

Programs (FSME) (see letter FSME 06-94 dated October 6, 2006 for further information).

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 STP website: http://www.hsrd.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, Kathleen

Schneider State Regulation Review Coordinator at 301-415-2320 or by e-mail at kxs@nrc.gov,

or Monica Orendi at 301-415-3938 or by e-mail at mlo1@nrc.gov.

Sincerely,

\RA By S.W. Moore\

Scott W. Moore, Deputy Director

Division of Materials Safety and State Agreements

Office of Federal and State Materials and

Enclosures: As Stated Environmental Management Programs

Distribution:

DIR RF (6-268 & 6-271) SUNSI Review Complete

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

Linda Mclean, RSAO : Non-Sensitive G Sensitive

McCraw, ASPO ML of Incoming Document:ML062860025/ML062750348

DOCUMENT NAME: C:\FileNet\ML063200232.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 MSEA SAIS OGC MSSA:DD

NAME [MOrendi KSchneider FCameron SMoore

DATE 10/26/06* 10/31/06* 11/13/06* 11/ /06

ML06300232 OFFICIAL RECORD COPY PKG.ML063200236
COMPATIBILITY COMMENTS ON TEXAS FINAL REGULATIONS

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

1 289.201

(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.

2 289.202(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.

3 289.252 (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).

4 289.256 (c)(9) 35.2 2002-2 B Definitions: Authorized medical

physicist

Texas’s definition for Licensed medical

physicist does not closely identify with the

definition listed in 10 CFR 35.2 for

Authorized medical physicist.

Texas needs to change their definition of

Licensed medical physicist to meet the

Compatibility Category B designation

assigned to Authorized medical physicist

in 10 CFR 35.2.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

5 35.2 2002-2 B Definitions: Authorized nuclear

pharmacist

Texas omits the definition for Authorized

nuclear pharmacist from its regulations.

Texas needs to add this definition in order

to meet the Compatibility Category B

designation assigned to Authorized

nuclear pharmacist in 10 CFR 35.2

6 289.256(c)(3) 35.2 2002-2 B Definitions: Authorized user

Texas’s definition of Authorized user does

not closely identify with the definition listed

in 10 CFR 35.2

Texas needs to change its definition of

Authorized user to meet the Compatibility

Category B designation assigned to this

definition in 10 CFR 35.2.

7 289.201

(b)(79)

35.2 2002-2 B Definitions: Radiation Safety Officer

Texas’s definition of Radiation Safety

Officer does not closely identify with the

definition listed in 10 CFR 35.2.

Texas needs to change this definition to

meet the Compatibility Category B

designation assigned to Radiation Safety

Officer in 10 CFR 35.2.

8 289.256(s) 35.49 2002-2 [C] Suppliers for sealed sources or

devices for medical use

Texas omits 10 CFR 35.49 (b) and (c)

from its regulations.

Texas needs to change its regulation to

include the essential elements of 10 CFR

35.49 (b) and (c) to meet the

Compatibility Category C designation

assigned to 10 CFR 35.49.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

9 289.256(h) 35.50 2002-2 B Training for Radiation Safety Officer

Texas regulation 289.256(h) is not

essentially identical to 10 CFR 35.50(a),

(a)(1), (b)(1)(ii)(F), (c)(2), and(e). 

Also Texas regulation 289.256 (h) states

”...qualifications for RSOs for licenses for

medical use of radioactive material with

broad scope authorization shall include...”. 

10 CFR 35.50 makes no such distinction

for RSO’s with broad scope authorization. 

This section needs to be removed from

the Texas regulations.

Texas needs to change the above items

in order to meet the Compatibility

Category B designation assigned to 10

CFR 35.50.

10 35.51 2002-2 B Training for an authorized medical

physicist

Texas omits 10 CFR 35.51 from its

regulations.

Texas needs to incorporate this section in

order to meet the Compatibility category B

designation assigned to 10 CFR 35.51.

11 35.55 2002-2 B Training for an authorized nuclear

pharmacist

Texas omits 10 CFR 35.55 from its

regulations.

Texas needs to incorporate this section in

order to meet the Compatibility category B

designation assigned to 10 CFR 35.55.

12 289.256 (h) 

289.256

(ff)(1)(H)

35.57 2002-2 B Training for experienced Radiation

Safety Officer, teletherapy or medical

physicist, authorized user and nuclear

pharmacist

Texas needs to change the date listed in

section 289.256 (h) from October 1, 2000

to October 24,2002.

Texas needs to make the change to the

date in order to meet the Compatibility

Category B designation assigned to 10

CFR 35.57.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

13 289.256

(ff)(1)(l)

35.59 2002-2 B Recentness of training

Texas is more restrictive in their

regulation stating that “...must have been

obtained within 5 years...”. Where as 10

CFR 35.59 states “... must have been

obtained within 7 years...”. 

Texas needs to make the above change

to meet the Compatibility Category B

designation assigned to 10 CFR 35.59.

14 35.61(a)(1), (a)(2),

(b), (c)

2002-2 H&S Calibration of survey instruments

Texas omits 10 CFR 35.61 from its

regulations.

Texas needs to add the essential

elements of this section in order to meet

the Compatibility Category H&S

designation assigned to 10 CFR 35.61.

15 289.256

(dd)(13)

35.80(a)(2), (a)(3),

(b)

2002-2 H&S Provision of mobile medical service

Texas omits 10 CFR 35.80(b) from its

regulations.

Texas needs to add the essential

objectives of this section in order to meet

the Compatibility Category H&S assigned

to 10 CFR 35.80(b)

16 289.256 (y) 35.190 2002-2 B Training for uptake, dilution, and

excretion studies

Texas omits 10 CFR 35.190(c)(2) from its

regulations.

Texas needs to add this section in order

to meet the Compatibility Category B

designation assigned to 10 CFR 35.190.

17 289.256(z)(4) 35.290 2002-2 B Training for imaging and localization

studies

Texas omits 10 CFR 35.290(b)(2)

from its regulations.

Texas needs to add this section in

order to meet the Compatibility

Category B designation assigned to

10 CFR 35.290.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

18 289.256

(aa)(4)

35.390 2002-2 B Training for use of unsealed byproduct

material for which a written directive is

required

Texas’s regulation does not closely

identify with 10 CFR 35.390 in its entirety.

Texas needs to change its regulations to

closely identify with this section in order to

meet the Compatibility Category B

designation assigned to 10 CFR 35.390.

19 289.256

(ff)(1)(C)

35.392 2002-2 B Training for the oral administration od

sodium iodide I-131 requiring a written

directive in quantities less than or

equal to 1.22 Gigabecquerels (33

millicuries)

Texas omits 10 CFR 35.392 (c)(2) from

its regulations.

Texas needs to add this section in order

to meet the Compatibility Category B

designation assigned to 10 CFR 35.392.

20 289.256

(ff)(1)(C)

35.394 2002-2 B Training for the oral administration od

sodium iodide I-131 requiring a written

directive in quantities greater than 1.22

Gigabecquerels (33 millicuries)

Texas omits 10 CFR 35.394 (c)(2) from

its regulations.

Texas needs to add this section in order

to meet the Compatibility Category B

designation assigned to 10 CFR 35.394.

21 35.433(a) 2002-2 H&S Decay of Strontium-90 sources for

ophthalmic treatments

Texas omits 10 CFR 35.433(a) from its

regulations.

Texas needs to add the essential

elements of this section in order to meet

the Compatibility Category H&S

designation assigned to this section.

22 289.256

(ff)(1(D)

35.490 2002-2 B Training for use of manual

brachytherapy sources

Texas omits 10 CFR 35.490 (b)(3) from

its regulations.

Texas needs to add this section in order

to meet the Compatibility category B

designation assigned to 10 CFR 35.490.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

23 289.256

(ff)(1)(E)

35.491 2002-2 B Training for ophthalmic use of

Strontium-90

Texas omits 10 CFR 35.491 (b)(3) from

its regulations. 

Texas needs to add this section to meet

the Compatibility Category B designation

assigned to 10 CFR 35.491.

24 289.256

(dd)(17)

35.690 2002-2 B Training for remote afterloader units,

teletherapy units, and gamma

stereotactic radiosurgery units

Texas’s regulation omits 10 CFR

35.690(b)(2).

Texas needs to add this section in order

to meet the Compatibility Category B

designation assigned to 10 CFR 35.690. 
STATE REGULATION STATUS

State: Texas(5 Amendments reviewed identified by a i Tracking T

at the beginning of the equivalent NRC requirement.) Date: Nov

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]-Parts30, 40 

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

ML052060129

Y 9/29/05ML052720491

 Licensing and Radiation Safety Requirements for Irradiators-Part36

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 iSelf-Guarantee as an Additional Financial Mechanism-Parts 30,40, 70 

58 FR 68726; 59 FR 1618(none)

1994-1 F

ML062860025

N 11/21/06ML06300232

Uranium Mill Tailings Regulations: Conforming NRCRequirements 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

ML052060129

N 9/29/05 

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

 Low-Level Waste Shipment Manifest Information and Reporting- 60 FR 15649; 60 FR 25983 1995-3 F Y 10/31/05 
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

Parts 20, 61 (3/1/98) ML051520266 ML053050013Performance 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 MaterialsParts 20, 35 60 FR 48623; (10/20/98) 1995-7 FML051520266 N 10/31/05 ML053050013  10 CFR Part 71: Compatibility with the International AtomicEnergy Agency-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 

iTermination 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 11/21/06ML06300232

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 UnderExclusive Federal Jurisdiction Within an Agreement State-Part 150

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

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 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
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

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

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

1998-1

Self-Guarantee of Decommissioning Funding by Nonprofit andNon-Bond-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 Licenses for Industrial Radiography and Radiation SafetyRequirements for Industrial Radiographic Operations-Part 34

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

ML051520266

Y 10/31/05ML053050013

Minor Corrections, Clarifying Changes, and a Minor PolicyChange-Parts 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 

iRespiratory Protection and Controls to Restrict InternalExposure-Part 20

64 FR 54543; 64 FR 55524(2/2/03)

1999-3 F

ML062750348

Y 11/21/06ML06300232

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

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

ML051520266

Y 8/12/05ML052280032

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

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

ML062750348

Y 11/21/06ML06300232
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

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.

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

ML062750348

Y 11/21/06ML06300232

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

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

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

2005-2

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

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