September 29, 2009 

Cynthia C. Cardwell, Manager 

Radiation Group 

Policy, Standards, and Quality Assurance Unit 

Department of State Health Services 

1100 West 49th Street, MC 2828 

Austin, TX 78756-3189 

Dear Ms. Cardwell: 

We have reviewed proposed revision and final revisions to the Texas regulations, 25 Texas 

Administrative Code 289.201, 289.203, 289.251, and 289.252 received by our office on August 18, 

2009. These regulations were reviewed by comparison to the equivalent Nuclear Regulatory 

Commission (NRC) rules in 10 CFR Parts 20, 30, 31, 32, 33, 35, 40, 61, 70 and 150 the 

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

Data Sheet. We discussed our review of the regulations with you on September 29, 2009. 

As a result of our review, we have eight 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 Aas published@ regulations be provided to us for review. As requested in FSME 

Procedure SA-201, AReview 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://nrc-stp.ornl.gov/rulemaking.html. 
Page 2 

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) or Shirley 

Xu, at (301) 415-7640 (shirley.xu@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 
Page 2 

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) or Shirley 

Xu, at (301) 415-7640 (shirley.xu@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 (9-39) SUNSI Review Complete 

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

LMcLean, RIV : Non-Sensitive G Sensitive 

BRautzen, ASPB 

JKatanic, ASPB 

TX File 

DOCUMENT NAME: G:\DMSSA\SAISB\REGULATION TOOLBOX\States\Texas\9-39 

Incoming Document: ML092260388 & ML092370352 

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 DMSSA:DD 

NAME SXu KSchneider BJones DWhite TReis 

DATE 09/ /09 09/ 11 /09 09/ 28 /09 09/ 29 /09 09/ 29 /09 

ML092450699 OFFICIAL RECORD COPY Package: ML092450682 
COMPATIBILITY COMMENTS ON TEXAS PROPOSED REGULATIONS 

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

1 289.251 

(e)(3)(C) 

'30.20(a) 2007-3 B Gas and aerosol detectors 

containing byproduct material 

Texas has omitted the phrase “or 

initially transfer for sale or distribution” 

when discussing the requirements for 

an exemption to the licensing 

requirements of gas and aerosol 

detectors containing byproduct 

material. 

Texas needs to add the phrase to 

289.251(e)(3)(C) to meet the 

Compatibility Category B designation 

assigned to Section 10 CFR 30.20(a). 

2 289.251(f) '31.12 2007-3 C General license for certain items 

and self-luminous products 

containing radium-226 

Texas has omitted the requirements 

of paragraphs 10 CFR 31.12(a)(1) 

through 10 CFR 31.12(a)(5). These 

requirements list the products for 

issuance of the general license under 

this part. 

Texas needs to add these paragraphs 

to 289.251(f) to meet the 

Compatibility Category C designation 

assigned to Section 10 CFR 31.12. 

3 289.201(b) '35.2 2007-3 H&S Definition: Positron Emission 

Tomography (PET) radionuclide 

production facility 

Texas has omitted the definition for 

Positron Emission Tomography (PET) 

radionuclide production facility from 

their regulations. 

Texas needs to adopt the definition of 

Positron Emission Tomography (PET) 

radionuclide production facility to 

289.201(b) to meet the Compatibility 

Category H&S designation assigned 

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

4 289.256(ff) '35.100 (a) and 

(b) 

2007-3 H&S Use of unsealed byproduct 

material for uptake, dilution, and 

excretion studies for which a 

written directive is not required 

Texas omitted the requirements for 

PET radionuclide production when 

discussing methods with which to 

obtain medical isotopes for uptake, 

dilution, and excretion studies for 

which a written directive is not 

required. 

Texas needs to add the PET 

production requirements to 

289.256(ff) to meet the Compatibility 

Category H&S designation assigned 

to Section 10 CFR 35.100 (a) and (b).

5 289.256(hh) '35.200 (a) and 

(b) 

2007-3 H&S Use of unsealed byproduct 

material for imaging and 

localization studies for which a 

written directive is not required. 

Texas omitted the requirements for 

PET radionuclide production when 

discussing methods with which to 

obtain medical isotopes for imaging 

and localization studies for which a 

written directive is not required. 

Texas needs to add the PET 

production requirements to 

289.256(hh) to meet the Compatibility 

Category H&S designation assigned 

to Section 10 CFR 35.200 (a) and (b). 

6 289.256(kk) ' 35.300 (a) and 

(b) 

2007-3 H&S Use of unsealed byproduct 

material for which a written 

directive is required 

Texas omitted the requirements for 

PET radionuclide production when 

discussing methods with which to 

obtain medical isotopes for for which 

a written directive is required. 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

Texas needs to add the PET 

production requirements to 

289.256(kk) to meet the Compatibility 

Category H&S designation assigned 

to Section 10 CFR 35.300 (a) and (b). 

7 N/A §32.13 2007-2 C Same: Prohibition of introduction 

Texas has omitted the requirement 

prohibiting the introduction of 

byproduct material to a product with 

the knowledge that it will be 

transferred to persons exempt under 

10 CFR 30.14. 

Texas needs to adopt this paragraph 

in their regulations to meet the 

Compatibility Category C designation 

assigned to Section 10 CFR 32.13.

8 289.252(gg) '40.36 2003-1 H&S ONGOING COMMENT FROM 

LETTER DATED JANUARY 2, 2008 

Financial assurance and 

recordkeeping for 

decommissioning 

Texas uses the words radioactive 

material to encompass byproduct and 

source material. However by doing 

this and referencing Figure 

289.252(jj)(2) Texas shows its 105 

limits for natural thorium and uranium 

at 10Ci, well above the 100mCi limit 

set in 10 CFR 40.36 for source 

material. Texas should move natural 

thorium and uranium in its table to the 

row with the limit of 1.0uCi and a 105

limit of 100mCi. 

Texas needs to move natural uranium 

and thorium in its Figure 

289.252(jj)(2) in order to meet the 

Compatibility category H&S 

designaiton assigned to 10 CFR 

40.36. 
STATE REGULATION STATUS

State: Texas Department of Health 

 Tracking Ticket Number: 9-39 

[4 amendment(s) reviewed is identified by a i Date: September 29, 2009 

at 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 has adopted Final Regulations equivalent to RATS ID: 1997-5. 

1991-2 ASNT Certification of Radiographers 

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

none Not Required Not Required Texas has adopted Final Regulations 

equivalent to RATS ID: 1997-5. 

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 has adopted Final Regulations 

equivalent to RATS ID: 2002-2. 

1992-2 Eliminating the Recordkeeping Requirements 

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

none Not Required Not Required These regulation changes are not 

required to be adopted for purposes of Compatibility. 

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 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

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 

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

Part 61 58 FR 33886 

07/22/1996 Not Applicable Not Applicable Texas DOH does not have responsibility 

for these regulations. See SRS sheet for Texas CEQ. 

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 regulation changes are not required to be adopted for purposes of Compatibility. 

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 CEQ Responsibility 

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 R1 

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 has adopted Final Regulations equivalent to RATS ID: 1997-5. 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

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 

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 has not yet adopted Final Regulations equivalent to RATS ID: 2005-2. 

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 has not yet adopted Final Regulations equivalent to RATS ID: 2004-1. 

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 regulation changes are not 

required to be adopted for purposes of Compatibility. 

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 only. Part 61 applies to 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 State Part 150 62 FR 1662 

02/27/2000 Final 

ML063030232 

No Comments 11/27/2006 ML063200389 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

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 regulation changes are not 

required to be adopted for purposes of Compatibility. (See STP-97-078) 

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 regulation changes are not 

required to be adopted for purposes of Compatibility. 

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 regulation changes are not 

required to be adopted for purposes of Compatibility. (See STP-98-074) Texas has adopted Final Regulations equivalent to RATS ID: 2002-2. 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

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 

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 regulation changes are not 

required to be adopted for purposes of Compatibility. 

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 only in 2007 review 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

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 

No Comments 09/29/2009 ML092450682 

2002-2 Medical Use of Byproduct Material 

Parts 20, 32, 35 67 FR 20249 

10/24/2005 R1

ML073170379 

Comments 01/02/2008 ML080020160 

2003-1 Financial Assurance for Materials Licensees 

Parts 30, 40, 70 68 FR 57327 

12/03/2006 Proposed 

ML073170379 

Comments 09/29/2009 ML092450682 

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 Proposed 

ML071370165 

Comments 06/27/2007 ML071790090 

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 Proposed 

ML071370165 

Comments 06/27/2007 ML071790090
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

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 Proposed 

ML092260388 

Comments 09/29/2009 ML092450682 

2007-3 Requirements for Expanded Definition of Byproduct 

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

11/30/2010 Proposed 

ML092260388 

Comments 09/29/2009 ML092450682 

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 

1 R stands for proposed changes to final regulations.