October 29, 2009 

Cindy Cardwell, Manager 

Radiation Policy, Standards and Q/A Group 

Department of State Health Services 

P.O. Box 149347 

Austin, TX 78714-9347 

Dear Ms. Cardwell: 

We have reviewed the final revision to the Texas Department of State Health Services 

regulations 25 T.A.C. 289, received by our office on September 2, 2009. These regulations 

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

10 CFR Parts 20, 32, and 35 and the requirements of the two amendments identified in the 

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

regulations with Monica Perez on October 27, 2009. 

As a result of our review, we have 11 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 Federal and State Materials and 

Environmental Management Programs (FSME) Procedure SA-200. 

We request that when you revise your regulations to address our comments, a copy of the Aas 

published@ regulations be provided to us for review. As requested in FSME Procedure SA-201, 

AReview 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, FSME. 

The SRS Data Sheet summarizes our knowledge of the status of other Texas Department of 

State Health Services 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://nrcstp.ornl.gov/rulemaking.html. 

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 

(kathleen.schneider@nrc.gov). 

 

Sincerely, 

/RA/ 

Terrence Reis, 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 

Radiation Policy, Standards and Q/A Group 

Department of State Health Services 

P.O. Box 149347 

Austin, TX 78714-9347 

Dear Ms. Cardwell: 

We have reviewed the final revision to the Texas Department of State Health Services regulations 25 T.A.C. 289, 

received by our office on September 2, 2009. These regulations were reviewed by comparison to the equivalent 

Nuclear Regulatory Commission (NRC) rules in 10 CFR Parts 20, 32, and 35 and the requirements of the two 

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

regulations with Monica Perez on October 27, 2009. 

As a result of our review, we have 11 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 Federal and State Materials and 

Environmental Management Programs (FSME) Procedure SA-200. 

We request that when you revise your regulations to address our comments, a copy of the Aas published@ regulations 

be provided to us for review. As requested in FSME Procedure SA-201, AReview 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, FSME. 

The SRS Data Sheet summarizes our knowledge of the status of other Texas Department of State Health Services 

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://nrc-stp.ornl.gov/rulemaking.html. 

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 (kathleen.schneider@nrc.gov). 

 

Sincerely, 

/RA/ 

Terrence Reis, 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 (9-41) SUNSI Review Complete 

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

LMcLean, RSAO : Non-Sensitive G Sensitive 

WRautzen, JKatanic, POC 

TX File 

DOCUMENT NAME: G:\DMSSA\SAISB\REGULATION TOOLBOX\STATES\TEXAS\9-41\9-41.DOC 

 ML of Incoming Document: ML092400365 

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 ASPB ASPB OGC ASPB:BC MSSA:DD 

NAME MOrendi KSchneider/MLO BJones DWhite TReis 

DATE 10/14/09 10/14/09 10/23/09 10/29/09 10/29/09 

ML092870334 OFFICIAL RECORD COPY Package ML092870302
 COMPATIBILITY COMMENTS ON TEXAS FINAL REGULATIONS 

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

1 289.252(r) 32.72 2002-2 B Manufacture, preparation, or 

transfer for commercial distribution 

of radioactive drugs containing 

byproduct material for medical use 

under Part 35 

Texas is more restrictive by adding 

requirements to labeling required for a 

syringe or vial. Texas needs to 

remove 289.252(r)(1)(C)(ii)(II) & (III) 

from its regulation. 

Texas omits an equivalent section to 

10 CFR 32.72(b)(3) from its 

regulations. Texas needs to add 

equivalent text to 289.252(r). 

Texas needs to make the above 

changes to 289.252(r) in order to 

meet the Compatibility Category B 

designation assigned to 10 CFR 

32.72. 

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

sources or devices containing 

byproduct material for medical use 

Texas omits 289.256(q) from the 

introductory paragraph in 289.252(o). 

 The sentence should read “...or for 

use of sealed sources listed in 

289.256(q), (rr), (bbb), and (ddd) of 

this title ...” 

Texas also allows in 289.252(o)(2) for 

“...labeling for sealed sources that do 

not require long-term storage 

may be on a leaflet or brochure that 

accompanies the sealed source;”. 

NRC does not have an equivalent 

provision in its regulations making 

Texas’ regulation less restrictive. 

Texas needs to remove this wording 

from 289.252(o)(2). 

Texas needs to make the above 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

changes to 289.252(o) in order to 

meet the Compatibility Category B 

designation assigned to 10 CFR 

32.74. 

3 289.256 

(c)(3) 

35.2 2002-2 B Definition: 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. 

4 289.256 

(c)(4) 

35.2 2002-2 B Definition: 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 omitted an “or” at the end of 

289.256(c)(4)(B)(iv). 

Texas needs to make the above 

changes to their definition of 

Authorized Nuclear Pharmacist to 

meet the Compatibility Category B 

designation assigned to 10 CFR 35.2 

Definition: Authorized Nuclear 

Pharmacist. 

5 289.256 

(c)(5) 

35.2 2002-2 B Definition: Authorized user 

Texas adds additional text to this 

definition making it more restrictive 

that NRC’s definition. Texas requires 

the physician, dentist, and podiatrist 

be licensed by the Texas Medical 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

Board, the Texas State Board of 

Dental Examiners, and the Texas 

State Board of Podiatric Medicine 

respectfully. Texas needs to remove 

this language from the definition. 

Texas needs to make the above 

change to 289.256(c)(5) in order to 

meet the Compatibility Category B 

designation assigned to 10 CFR 35.2 

Definition Authorized User.

6 289.256 

(c)(22) 

35.2 2002-2 C Definition: Prescribed dosage 

Texas uses the term 

“radiopharmaceutical” instead of 

unsealed byproduct material in their 

definition of Prescribed dosage. This 

makes their definition less restrictive 

than NRC’s definition. 

Texas needs to remove the word 

radiopharmaceutical and replace it 

with unsealed byproduct material (or 

unsealed radioactive material) in 

order to meet the Compatibility 

Category C designation assigned to 

10 CFR 35.2 Definition Prescribed 

Dosage.

7 289.201 

(B)(94) 

35.2 2002-2 [B] Definition: Sealed Source 

Texas adds language to their 

definition of Sealed Source and 

device which makes the definition less 

restrictive than NRC’s definition. 

Texas needs to remove “under the 

most severe conditions that are likely 

to encountered in normal use and 

handling” from the definition. 

Texas needs to make the above 

change in order to meet the 

Compatibility Category [B] designation 

assigned to 10 CFR 35.2 Definition 

Sealed Source. 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

8 289.256(r) 35.11 2002-2 [C] License Required 

Texas submitted a cross walk stating 

that this section’s equivalent was 

289.256(r), however there is no 

equivalent text in this section to 10 

CFR 35.11. 

Texas needs to add a section 

equivalent to 10 CFR 35.11 in order to 

meet the Compatibility Category [C] 

designation assigned to 10 CFR 

35.11.

9 289.256(h) 35.50 2002-2 

2005-2 

B Training for the Radiation Safety 

Officer 

Texas lists the wrong citation in the 

introductory paragraph of 

289.256(h)(1). Texas states “... and 

who meets the requirements of 

sections (4) and (5) of this 

subsection.” The correct statement is 

“...and who meets the requirements 

of sections (5) and (6) of this section.” 

Texas needs to make the above 

change to 289.256(h) in order to meet 

the Compatibility Category B 

designation assigned to 10 CFR 

35.50.

10 289.256(jj) 35.290 2002-2 

2005-2 

B Training for imaging and 

localization studies 

Texas regulation 289.256(jj)(2) 

contains additional 

requirements for the use of 

PET radionuclides. This paragraph is 

more restrictive than Section 35.290 

and should be removed. 

Texas needs to make the above 

change 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 

11 289.202 

(bbb) 

35.3067 2002-2 C Report of a leaking source 

Texas omits that the written report 

must include “the model number and 

serial number if assigned of the 

leaking source, and the radionuclide 

and its estimated activity” making their 

regulation less restrictive. 

Texas needs to add the above to 

289.202(bbb) in order to meet the 

Compatibility Category C designation 

assigned to 10 CFR 35.3067. 
STATE REGULATION STATUS

State: Texas Department of Health Tra[2 amendment(s) reviewed is identified by a i Daat the beginning of the equivalent NRC requirement.] 

RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

1991-1 Safety Requirements for Radiographic Equipment 

Part 34 55 FR 843 (Superceded by 1997-5) 

01/10/1994 Final 

ML051520266 

No Comments 10/31/2005 ML053050013 

Texas equiva

1991-2 ASNT Certification of Radiographers 

Part 34 56 FR 11504 (Superceded by 1997-5) 

none Not Required Not Required Texas 

equiva

1991-3 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; 

01/01/1994 Final No Comments 

11/06/1997 

1991-4 Notification of Incidents 

Parts 20, 30, 31, 34, 39, 40, 70 56 FR 64980; 

10/15/1994 Final 

ML052060129 

No Comments 09/29/2005 ML052720491 

1992-1 Quality Management Program and Misadministrations 

Part 35 56 FR 34104 (Superceded by 2002-2)

01/27/1995 Not Required Not Required Texas 

equiva

1992-2 Eliminating the Recordkeeping Requirements 

for Departures from Manufacturer's Instructions Parts 30, 35 57 FR 45566 

none Not Required Not Required These 

requireCompa

1993-1 Decommissioning Recordkeeping and License 

Termination: Documentation Additions [Restricted areas and spill sites] Parts 30, 40 58 FR 39628 

10/25/1996 Final 

ML052060129 

Comments 09/29/2005 ML052720491 

1993-2 Licensing and Radiation Safety Requirements for 

Irradiators Part 36 58 FR 7715 

07/01/1996 Final 

ML051520266 

No Comments 08/12/2005 ML052280032 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

1993-3 Definition of Land Disposal and Waste Site QA Program 

Part 61 58 FR 33886 

07/22/1996 Not Applicable Not Applicable Texas 

responSee S

1994-1 Self-Guarantee as an Additional Financial Mechanism 

Parts 30, 40, 70 58 FR 68726; 59 FR 1618 

none Final 

ML062860025 

No Comments 11/21/2006 ML063200232 

These requireCompa

1994-2 Uranium Mill Tailings Regulations: Conforming NRC 

Requirements to EPA Standards Part 40 59 FR 28220 

07/01/1997 Not Applicable Not Applicable Texas 

1994-3 Timeliness in Decommissioning Material Facilities 

Parts 30, 40, 70 59 FR 36026 

08/15/1997 Final 

ML052060129 

No Comments 09/29/2005 ML052720491 

1995-1 Preparation, Transfer for Commercial Distribution, and 

Use of Byproduct Material for Medical Use Parts 30, 32, 35 59 FR 61767; 59 FR 65243; 60 FR 322 

01/01/1998 Final No Comments 

03/17/1999 

1995-2 Frequency of Medical Examinations for Use of 

Respiratory Protection Equipment Part 20 60 FR 7900

03/13/1998 Final 

ML051520266 

No Comments 10/31/2005 ML053050013 

1995-3 Low-Level Waste Shipment Manifest Information and 

Reporting Parts 20, 61 60 FR 15649; 60 FR 25983 

03/01/1998 Ri 

ML071370165 

Comments 06/27/2007 ML071790090 

1995-4 Performance Requirements for Radiography Equipment 

Part 34 60 FR 28323 (Superceded by 1997-5) 

06/30/1998 Final 

ML051520266 

No Comments 10/31/2005 ML053050013 

Texas equiva

1995-5 Radiation Protection Requirements: Amended Definitions 

and Criteria Parts 19, 20 60 FR 36038 

08/14/1998 Final No Comments 

03/17/1999 

1995-6 Clarification of Decommissioning Funding Requirements 

Parts 30, 40, 70 60 FR 38235 

11/24/1998 Final 

ML052060129 

No Comments 09/29/2005 ML052720491 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

1995-7 Medical Administration of Radiation and Radioactive 

Materials Parts 20, 35 60 FR 48623 (Superceded by 2002-2 and 2005-2) 

10/20/1998 Final 

ML051520266 

No Comments 10/31/2005 ML053050013 

Texas Regula2005-2

1996-1 Compatibility with the International Atomic Energy Agency

Part 71 60 FR 50248; 61 FR 28724 (Superceded by 2004-1) 

04/01/1999 Final 

ML052060129 

Comments 09/29/2005 ML052720491 

Texas Regula2004-1

1996-2 One Time Extension of Certain Byproduct, Source and 

Special Nuclear Materials Licenses Parts 30, 40, 70 61 FR 1109 

02/15/1999 Not Required Not Required These 

requireCompa

1996-3 Termination or Transfer of Licensed Activities: Record 

keeping Requirements Parts 20, 30, 40, 61, 70 61 FR 24669 

06/17/1999 Final 

ML062860025 

No Comments 11/21/2006 ML063200232 

Part 30 TXCEQ

1997-1 Resolution of Dual Regulation of Airborne Effluents of 

Radioactive Materials; Clean Air Act Part 20 61 FR 65120 

01/9/2000 Final No Comments 

07/07/2000 

1997-2 Recognition of Agreement State Licenses in Areas Under 

Exclusive Federal Jurisdiction Within an Agreement StatePart 150 62 FR 1662 

02/27/2000 Final 

ML063030232 

No Comments 11/27/2006 ML063200389 

1997-3 Criteria for the Release of Individuals Administered 

Radioactive Material Parts 20, 35 62 FR 4120 

05/29/2000 Final No Comments 

07/07/2000 

1997-4 Fissile Material Shipments and Exemptions 

Part 71 62 FR 5907 (Superceded by 2004-1) 

02/10/2000 Not Required Not Required These 

requireCompa
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

1997-5 Licenses for Industrial Radiography and Radiation Safety 

Requirements for Industrial Radiography Operations Parts 30, 34, 71, 150 62 FR 28947 

06/27/2000 Final No Comments 

07/07/2000 

1997-6 Radiological Criteria for License Termination 

Parts 20, 30, 40, 70 62 FR 39057 

08/20/2000 Final No Comments 

07/07/2000 

1997-7 Exempt Distribution of a Radioactive Drug Containing 

One Micro curie of Carbon-14 Urea Part 30 62 FR 63634 

01/02/2001 Final 

ML052060129 

No Comments 09/29/2005 ML052720491 

1998-1 Deliberate Misconduct by Unlicensed Persons 

Parts 30, 40, 61, 70, 71, 150 63 FR 1890; 63 FR 13773 

02/12/2001 Final 

ML063030232 

No Comments 11/27/2006 ML063200389

1998-2 Self-Guarantee of Decommissioning Funding by Nonprofit 

and Non-Bond-Issuing Licensees Parts 30, 40, 70 63 FR 29535 

07/01/2001 Not Required Not Required These 

requireCompa

1998-3 License Term for Medical Use Licenses 

Part 35 63 FR 31604 (Superceded by 2002-2) 

07/10/2001 Not Required Not Required These 

requireCompaTexas equiva

1998-4 Licenses for Industrial Radiography and Radiation Safety 

Requirements for Industrial Radiographic Operations Part 34 63 FR 37059

07/09/2001 R1

ML071370165 

No Comments 06/27/2007 ML071790090 

1998-5 Minor Corrections, Clarifying Changes, and a Minor Policy 

Change Parts 20, 35, 36 63 FR 39477; 63 FR 45393 

10/26/2001 Final No Comments 

07/07/2000 

1998-6 Transfer for Disposal and Manifests: Minor Technical 

Conforming Amendment Part 20 63 FR 50127 

11/20/2001 Final No Comments 

07/07/2000 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

1999-1 Radiological Criteria for License Termination of Uranium 

Recovery Facilities Part 40 64 FR 17506

06/11/2002 Final 

ML051520266 

Comments 08/12/2005 ML052280032 

1999-2 Requirements for Those Who Possess Certain Industrial 

Devices Containing Byproduct Material to Provide Requested Information Part 31 64 FR 42269

10/04/2002 Not Required Not Required These 

requireCompa

1999-3 Respiratory Protection and Controls to Restrict Internal 

Exposure Part 20 64 FR 54543; 64 FR 55524 

02/02/2003 Final 

ML062750348 

No Comments 11/21/2006 ML063200232 

2000-1 Energy Compensation Sources for Well Logging and 

Other Regulatory Clarifications Part 39 65 FR 20337

05/17/2003 Final 

ML051520266 

No Comments 11/30/2006 ML063340007 

2000-2 New Dosimetry Technology 

Parts 34, 36, 39 65 FR 63750 

01/08/2004 Final 

ML051520266 Proposed ML073170379 

No Comments 08/12/2005 ML052280032 No Comments 01/02/2008 ML080020160

Part 36 

2001-1 Requirements for Certain Generally Licensed Industrial 

Devices Containing Byproduct Material Parts 30, 31, 32 65 FR 79162 

02/16/2004 R1

ML073170379 

Comments 01/02/2008 ML080020160 

2002-1 Revision of the Skin Dose Limit 

Part 20 67 FR 16298 

04/05/2005 Proposed 

ML083250011 

Comments 01/13/2009 ML083440015 

2002-2 Medical Use of Byproduct Material 

Parts 20, 32, 35 67 FR 20249 

10/24/2005 Final 

ML092390185 ML092400365 

Comments 10/29/2009 ML092870302 

2003-1 Financial Assurance for Materials Licensees 

Parts 30, 40, 70 68 FR 57327 

12/03/2006 Proposed 

ML073170379 

Comments 01/02/2008 ML080020160 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

2004-1 Compatibility With IAEA Transportation Safety Standards 

and Other Transportation Safety Amendments Part 71 69 FR 3697 

10/01/2007 Proposed 

ML072560678 

Comments 11/05/2007 ML073060016 

2005-1 Security Requirements for Portable Gauges Containing 

Byproduct Material Part 30 70 FR 2001 

07/11/2008 Proposed 

ML083250011 

No Comments 01/13/2009 ML083440015 

2005-2 Medical Use of Byproduct Material - Recognition of 

Specialty Boards Part 35 70 FR 16336; 71 FR 1926 

04/29/2008 Final 

ML092390185 ML092400365 

Comments 10/29/2009 ML092870302 

2005-3 Increased Controls for Risk-Significant Radioactive 

Sources (NRC Order EA-05-090)

70 FR 72128

12/01/2005 License Condition 

ML052240226 

No Comments 12/12/2005 ML053420404

2006-1 Minor Amendments 

Parts 20, 30, 32, 35, 40 and 70 71 FR 15005

03/27/2009 R1

ML092650466 

Comments 10/05/2009 ML092660410

2006-2 National Source Tracking System - Serialization 

Requirements Part 32 with reference to Part 20 Appendix E 71 FR 65685 

02/06/2007 R1

ML083250011 

No Comments 01/13/2009 ML083440015 

2006-3 National Source Tracking System 

Part 20 71 FR 65685, 72 FR 59162 

01/31/2009 R1

ML083250011 

No Comments 01/13/2009 ML083440015 

2007-1 Medical Use of Byproduct Material - Minor Corrections 

and Clarifications Parts 32 and 35 72 FR 45147, 54207 

10/29/2010 

2007-2 Exemptions From Licensing, General Licenses, and 

Distribution of Byproduct Material: Licensing and Reporting Requirements Parts 30, 31, 32, 150 72 FR 58473 

12/17/2010 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

2007-3 Requirements for Expanded Definition of Byproduct 

Material Parts 20, 30, 31, 32, 33, 35, 61, 150 72 FR 55864 

11/30/2010 

2007-4 Order Imposing Fingerprinting Requirements and Criminal

History Records Check Requirements for Unescorted Access to Certain Radioactive Material NRC Order EA-07-305 72 FR 70901 

06/05/2008 License Condition 

ML080350004 

No Comments 02/13/2008 ML080440203 

2008-1 Occupational Dose Records, Labeling Containers, and 

Total Effective Dose Equivalent Parts 19, 20 72 FR 68043 

02/15/2011 Proposed 

Ml083250011 

No Comments 01/13/2009 ML083440015 

2009-1 Medical Use of Byproduct Material – Authorized User 

Clarification Part 35 74 FR 33901 

09/28/2012 

i R stands for proposed changes to final regulations.