July 11, 2006

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 May 5, 2006 e-mail in response to our December 13, 2005 regulation

review letter which identified necessary revisions and recodification due to the Part 71 rule

revision and six rule amendments that have become due and will need to be adopted since the

2003 review. We have reviewed the final Pennsylvania regulations, 25 PA. Code Chapter 215

which address the six additional rule amendments and the proposed rule recodification due to

the Part 71 rule revision. These regulations were reviewed by comparison to the equivalent

NRC regulations in 10 CFR Parts 20, 30, 31, 32, 35, 40, 70, and 71 and the requirements of the

7 amendments identified in the enclosed State Regulation Status (SRS) Data Sheet. We

discussed our review of the regulations with Mr. Louis Ray Urciuolo on July 10, 2006.

As a result of our review, we have three 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 Pennsylvania, in response to our comments and provide a copy to STP.

Additionally, we understand that Pennsylvania plans to address the requirements of NRC Order

EA-05-090 (Increased Controls for Risk-Significant Radioactive Sources) through Order until

such time as NRC adopts regulations to address these requirements. Pennsylvania will need to

adopt and submit these legally binding requirements to the NRC for a compatibility review prior

to becoming an Agreement State.

The SRS Data Sheet 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. 
David J. Allard, CHP, Director -2- July 11, 2006

If you have any questions regarding the review results, the compatibility and health and safety

categories, or any of the NRC regulations used in the review, please contact me, or Kevin

Hsueh at 301-415-2598 or by e-mail at kph@nrc.gov.

Sincerely,

RA By K.Schneider For\

Dennis K. Rathbun, Deputy Director

Office of State and Tribal Programs

Enclosure:

As stated
David J. Allard, CHP, Director -2- July 11, 2006

If you have any questions regarding the review results, the compatibility and health and safety

categories, or any of the NRC regulations used in the review, please contact me, or Kevin

Hsueh at 301-415-2598 or by e-mail at kph@nrc.gov.

Sincerely,

RA By K.Schneider For\

Dennis K. Rathbun, Deputy Director

Office of State and Tribal Programs

Enclosure:

As stated

Distribution:

DIR RF 6-144 Sunsi Review Complete

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

S. Minnick, RSAO : Non-Sensitive G Sensitive File

DOCUMENT NAME: E:\Filenet\ML061920410.wpd 

ML of Incoming Document: ML061290297

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 KHsueh SATreby KNSchneider for DKRathbun

DATE 6/27/06* 7/10/06* 7/11/06*

ML061920410 OFFICIAL RECORD COPY PKG.ML061920520
COMPATIBILITY COMMENTS ON PENNSYLVANIA PROPOSED REGULATIONS

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

1 215.1(e)(13) 71.14(b)

71.19

2004-1 NRC Adoption by Reference for IAEA

Transportation Amendments

Pennsylvania's regulations include

incorporation by reference for 

71.14(b) and 71.19 that are reserved to

NRC jurisdiction.

Pennsylvania needs to add 71.14(b)

and 71.19 to the list of items not

incorporated by reference in

215.1(e)(13). These requirements

are reserved to the NRC under 10

CFR 71 and should not be adopted

by reference.

2 215.1(e)(13) 71.13(c)&(d) 2004-1 B Adoption by Reference for IAEA

Transportation Amendments

Pennsylvania's regulations include

71.13(c)&(d) as not incorporated by

reference.

Pennsylvania needs to delete

71.13(c)&(d) reference from

215.1(e)(13) to meet the compatibility

category B designation assigned to

10 CFR 71.13(c)&(d).
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

3 215.1(e)(13) 71.101(c)(2), 

(d)&(e)

71.107

71.109

71.111

71.113

71.115

71.117

71.119

71.121

71.123

71.125

2004-1 NRC Adoption by Reference for IAEA

Transportation Amendments

Section 71.101(b) (Establishment of a

quality assurance program for

packaging), which is designated as

compatibility category C, states that

“Each licensee, certificate holder, and

applicant for a CoC shall establish,

maintain, and execute a quality

assurance program satisfying each of

the applicable criteria of §§ 71.101

through 71.137....” However,

sections 71.101(c)(2), (d) & (e),

71.107, 71.109, 71.111, 71.113,

71.115, 71.117, 71.119, 71.121,

71.123, and 71.125 have been

designated as compatibility category

NRC. Thus, for a state to adopt the

essential objectives of 71.101(b), as

would be required under compatibility

category C, it would be inadvertently

required to adopt requirements

contained in provisions reserved to

the NRC.

Recognizing this discrepancy, staff

members are re-reviewing the

compatibility designation of the

referenced sections. No changes to

the Pennsylvania regulations are

required until the NRC completes its

review of part 71 and reports its

results to the state. 
STATE REGULATION STATUS

State: Pennsylvania [7 Amendments reviewed identified by a i 

at the beginning of each equivalent NRC Regulation] 

NRC Chronology Identification FR Notice

(Date Due For StateImplementation)

RATS ID Proposed 

Final (F)1 R

/ LicenseCondition(LC) 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'sInstructions-Parts 30,35

57 FR 45566; (none) 1992-2 

Decommissioning Recordkeeping and License Termination: DocumentationAdditions [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 EPAStandards-Part 40

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

(Date Due For StateImplementation)

RATS ID Proposed 

Final (F)1 R

/ LicenseCondition(LC) ML #5

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 Materialfor Medical Use-Parts 30, 32, 35

59 FR 61767; 59 FR 6524360 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 FML0212702

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

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 MaterialsLicenses-Parts 30, 40, 70

61 FR 1109; (none) 1996-2 

Termination or Transfer of Licensed Activities: Recordkeeping Requirements-Parts20, 30, 40, 61, 70

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

ML0212702ML0518903

Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; CleanAir Act-Part 20

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

ML0212702

Recognition of Agreement State Licenses in Areas Under Exclusive FederalJurisdiction 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, 35 62 FR 4120; (5/29/00) 1997-3 FML0212702
NRC Chronology Identification FR Notice

(Date Due For StateImplementation)

RATS ID Proposed 

Final (F)1 R

/ LicenseCondition(LC) ML #5

Fissile Material Shipments and Exemptions-Part 71 62 FR 5907; (none) 1997-4 Licenses for Industrial Radiography and Radiation Safety Requirements forIndustrial 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-14Urea-Part 30 

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

ML0212702

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

(2/12/01)

1998-1 F

ML0212702ML0518903

Self-Guarantee of Decommissioning Funding by Nonprofit and Non-Bond-IssuingLicensees- 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 forIndustrial 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-Part20

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

ML0212702

Radiological Criteria for License Termination of Uranium Recovery Facilities-Part40

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

Requirements for Those Who Possess Certain Industrial Devices ContainingByproduct 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

Energy Compensation Sources for Well Logging and Other RegulatoryClarifications-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
NRC Chronology Identification FR Notice

(Date Due For StateImplementation)

RATS ID Proposed 

Final (F)1 R

/ LicenseCondition(LC) 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 Polic

Adequacy and Compatibility of Agreement State Programs,” III.1. Time Frame for Adoption of Compatible State Regulations, p. 6, 1995.

5. ADAMS ML Number6. 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 P

Agreement State application package.

i Requirements for Certain Generally Licensed Industrial Devices Containing

Byproduct Material-Parts 30, 31, 32

65 FR 79162; (2/16/04) 2001-1 F 5/5/06

ML0518903

i Revision of the Skin Dose Limit-Part 20 67 FR 16298; (4/5/05) 2002-1 F 5/5/06

ML0518903

i Medical Use of Byproduct Material-Parts 20, 32, and 35 67 FR 20249; (4/24/05) 2002-2 F 5/5/06

ML0518903

i Financial Assurance for Materials Licensees – Parts 30, 40, 70 68 FR 57327 12/3/06 2003-1 F 5/5/06

ML0518903

i Compatibility With IAEA Transportation Safety Standards and Other

Transportation Safety Amendments – Part 71.

69 FR 3697; (10/01/07) 2004-1 P 5/5/06

ML0518903

i Security Requirements for Portable Gauges Containing Byproduct Material - Part

30

70 FR 2001; (7/11/08) 2005-1 F 5/5/06

ML0518903

i Medical Use of Byproduct Material - Recognition of Specialty Boards - Part 35 70 FR 16336; 71 FR 1926

(4/29/08)

2005-2 F 5/5/06

ML0518903

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

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

Minor Amendments - Part 20, 30, 32, 35, 40 and 70 71FR15005 2006-1