December 13, 2005

David J. Allard, CHP, Director

Bureau of Radiation Protection

Department of Environmental Protection

Rachael Carson State Office Building

P.O. Box 8469

Harrisburg, PA. 17105-8469

Dear Mr. Allard:

We have reviewed your June 27, 2005 letter in response to the 11 comments from our May 15,

2003 regulation review letter. Comments 2, 3, 4, 5, and 7 address 10 CFR 71 that has been

subsequently revised and re-codified since our 2003 review. It is our understanding that

Pennsylvania will pursue rulemaking to reflect the significant revisions and recodification in the

latest revision to Part 71 and address our comments. Comments 1, 6, 8, 9, 10, and 11 were

addressed adequately and we have no further comments. Comments 8-11 were discussed

with Mr. Janati of your staff on October 4, 2005 

In addition to the Part 71 rule revision, we have identified six additional rule amendments and

an order, for a total of eight items that have become due and will need to be adopted since the

2003 review. Pennsylvania will need to adopt and submit these regulations or alternate generic

legally binding requirements to the NRC for a compatibility review, prior to becoming an

Agreement State. On October 5, 2005, we discussed with Mr. Urciolo and Mr. Seiber of your

staff the requirement to have the regulations adopted and found compatible by NRC prior to the

agreement being signed. The seven amendments and order are listed below. 

• “Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct

Material-Parts 30, 31, 32" (65 FR 79162; RATS ID 2001-1)

• “Revision of the Skin Dose Limit-Part 20" (67 FR 1629; RATS ID 2002-1)

• “Medical Use of Byproduct Material-Parts 20, 32, and 35" (67 FR 20249; RATS ID 2002-2)

• “Financial Assurance for Materials Licensees – Parts 30, 40, 70" (68 FR 57327; 

 RATS ID 2003-1)

• “Compatibility with IAEA Transportation Safety Standards and Other Transportation Safety

Amendments - Part 71" (69 FR 3697; RATS ID 2004-1)

• Security Requirements for Portable Gauges Containing Byproduct Material - Part 30" 

 (70 FR 2001; RATS ID 2005-1)

• “Medical Use of Byproduct Material - Recognition of Specialty Boards - Part 35"(70 FR 16336; 

 RATS ID 2005-2)

• Increased Controls for Risk-Significant Radioactive Sources (NRC Order EA-05-090) 
David Allard -2- December 14, 2005

The State Regulation Data Sheet (SRS) summarizes our knowledge of the status of other

Pennsylvania 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#PA. 

If you have any questions regarding the review results, the regulatory review process, the

compatibility and health and safety categories, or any of the NRC regulations used in the review,

please contact me, or Dr. Terry Brock at 301-415-2323 or by e-mail at tab2@nrc.gov.

Sincerely,

\RA By KNSchneider For\

Dennis K. Rathbun, Deputy Director

Office of State and Tribal Programs

Enclosure:

As stated
David Allard -2- December 14, 2005

The State Regulation Data Sheet (SRS) summarizes our knowledge of the status of other

Pennsylvania 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#PA. 

If you have any questions regarding the review results, the regulatory review process, the

compatibility and health and safety categories, or any of the NRC regulations used in the review,

please contact me, or Dr. Terry Brock at 301-415-2323 or by e-mail at tab2@nrc.gov.

Sincerely,

\RA By KNSchneider For\

Dennis K. Rathbun, Deputy Director

Office of State and Tribal Programs

Enclosure: As stated

Distribution:

DIR RF 5-357 SISP Review Complete

DCD (SP05) : Publicly Available G Non-Publicly Available

D.White, RSAO : Non-Sensitive G Sensitive File

DOCUMENT NAME: E:\Filenet\ML053470511.wpd 

ML of Incoming Document: ML051890349

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 OGC STP:DD

NAME TBrock STreby DRathbun

DATE 11/28/05* 12/12/05* 12/13/05*

ML053470511 OFFICIAL RECORD COPY
STATE REGULATION STATUS

State: Pennsylvania 

[Two Amendments reviewed identified by a i 

Tracking Ticket Number: 5-357

at the beginning of each equivalent NRC Regulation] Date:

Decem

ber 14,

2005

NRC Chronology Identification FR Notice

(Date Due For State

Implementation)

RATS ID Proposed 

Final (F)1 R

/ ML #5

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

ML0212702

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

ML0212702

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

ML0212702

Quality Management Program and Misadministrations-Part 35 56 FR 34104; (1/27/95) 1992-1 F

ML0212702

Eliminating the Recordkeeping Requirements for Departures from Manufacturer'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

ML0212702

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 F

ML0311102

Self-Guarantee as an Additional Financial Mechanism-Parts 30, 40, 70 58 FR 68726; 59 FR 1618

(none)

1994-1

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

ML0212702

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; (1/1/98)

1995-1 F

ML0212702

Frequency of Medical Examinations for Use of Respiratory Protection EquipmentPart 20 60 FR 7900; (3/13/98) 1995-2 F

ML0212702

Low-Level Waste Shipment Manifest Information and Reporting-Parts 20, 61 60 FR 15649; 60 FR 25983

(3/1/98)

1995-3 F

ML0212702

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

ML0212702

Radiation Protection Requirements: Amended Definitions and Criteria-Parts 19, 20 60 FR 36038; (8/14/98) 1995-5 F
NRC Chronology Identification FR Notice

(Date Due For State

Implementation)

RATS ID Proposed 

Final (F)1 R

/ ML #5

ML0212702

Clarification of Decommissioning Funding Requirements-Parts 30, 40, 70 60 FR 38235; (11/24/98) 1995-6 F

ML0212702

Medical Administration of Radiation and Radioactive Materials-Parts 20, 35 60 FR 48623; (10/20/98) 1995-7 F

ML0212702

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

ML0212702

One Time Extension of Certain Byproduct, Source and Special Nuclear Materials

Licenses-Parts 30, 40, 70

61 FR 1109; (none) 1996-2

iTermination or Transfer of Licensed Activities: Recordkeeping RequirementsParts 20, 30, 40, 61, 7061 FR 24669; (6/17/99) 1996-3 F

ML0212702

ML0518903

Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean

Air Act-Part 20

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

ML0212702

Recognition of Agreement State Licenses in Areas Under Exclusive Federal

Jurisdiction Within an Agreement State-Part 150

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

ML0212702

Criteria for the Release of Individuals Administered Radioactive MaterialParts 20, 3562 FR 4120; (5/29/00) 1997-3 F

ML0212702

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

Licenses for Industrial Radiography and Radiation Safety Requirements for

Industrial Radiography Operations-Parts 30, 34, 71, 150

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

ML0212702

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

ML0212702

Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14

Urea-Part 30 

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

ML0212702

iDeliberate Misconduct by Unlicensed Persons-Parts 30, 40, 61, 70, 71, 150 63 FR 1890; 63 FR 13773

(2/12/01)

1998-1 F

ML0212702

ML0518903

Self-Guarantee of Decommissioning Funding by Nonprofit and Non-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 Safety Requirements for

Industrial Radiographic Operations-Part 34

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

ML0212702

Minor Corrections, Clarifying Changes, and a Minor Policy Change-Parts 20, 35, 36 63 FR 39477; 63 FR 45393

(10/26/01)

1998-5 F

ML0212702

Transfer for Disposal and Manifests: Minor Technical Conforming Amendment-Part

20

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

ML0212702

Radiological Criteria for License Termination of Uranium Recovery Facilities-Part

40

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

Requirements for Those Who Possess Certain Industrial Devices Containing

Byproduct Material 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 F

ML0212702
NRC Chronology Identification FR Notice

(Date Due For State

Implementation)

RATS ID Proposed 

Final (F)1 R

/ 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 Policy Statement on Adequacy and Compatibility of Agreement State Programs,”

III.1. Time Frame for Adoption of Compatible State Regulations, p. 6, SECY-95-112, May 3, 1995.

5. ADAMS ML Number

6. These regulations are not required since authority over 11.e(2) material will not be transferred in the

Agreement.

7. The order will need to be incorporated as a generally binding license condition and will be reviewed by NRC

for compatibility once PA submits their Agreement State application package.

Energy Compensation Sources for Well Logging and Other Regulatory

Clarifications-Part 39

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

ML0212702

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

ML0212702

Requirements for Certain Generally Licensed Industrial Devices Containing

Byproduct Material-Parts 30, 31, 32

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

ML0518903

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

ML0518903

Medical Use of Byproduct Material-Parts 20, 32, and 35 67 FR 20249; (4/24/05) 2002-2

ML0518903

Financial Assurance for Materials Licensees – Parts 30, 40, 70 68 FR 57327 12/3/06 2003-1 ML0518903

Compatibility With IAEA Transportation Safety Standards and Other Transportation

Safety Amendments – Part 71.

69 FR 3697; (10/01/07)

2004-1

ML0518903

Security Requirements for Portable Gauges Containing Byproduct Material - Part

30

70 FR 2001; (7/11/08) 2005-1 ML0518903

Medical Use of Byproduct Material - Recognition of Specialty Boards - Part 35 70 FR 16336; (4/29/08) 2005-2 ML0518903

 Increased Controls for Risk-Significant Radioactive Sources (NRC Order EA-05-

090)7

TBD FR TBD; (12/2/05) 2005-3