May 15, 2003

David J. Allard, CHP, Director

Bureau of Radiation Protection

 Department of Environmental Protection

Rachel Carson State Office Building

P.O.Box 8469

Harrisburg, PA. 17105-8469

Dear Mr. Allard:

As requested, we have reviewed the final Pennsylvania regulations, 25 PA. Code Chapters 215,

217, 219, 220, 224 - 226, 230 and 232, enclosed in your April 19, 2002 letter and which was

received by this office on May 2, 2002. These regulations were reviewed by comparison to the

equivalent NRC regulations in 10 CFR Parts 19, 20, 30, 31, 32, 33, 34, 35, 36, 39, 40, 61, 70,

71, 150 and the requirements of the 35 amendments identified in the enclosed State Regulation

Status (SRS) Data Sheet. In addition, we reviewed our January 5, 2001, letter to you that

addressed the proposed regulations and your response to our comments. We discussed our

review of the regulations with you on May 5, 2003.

As a result of our review, we have identified 11 comments, as enclosed. We did not review

your incorporation of 10 CFR 35 because your incorporation references, documented in 25 PA.

Code Chapter 215, were for the old Part 35 medical rules. If the State would like to incorporate

this section by reference, it is requested that you change your incorporation references and

submit this section again. Please note, that we have limited our review to regulations required

for compatibility and/or health and safety. 

Please provide an amended final version of your rules showing the location of any changes

made by the State in response to our comments. If there are any comments which the State

believes are in error, the State should identify the section of their regulations that meet the

designated compatibility category and submit these sections to the NRC for review.

The SRS Data Sheet summarizes our knowledge of the Pennsylvania regulations. 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 Web Site:

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, or John Zabko

of my staff at (301) 415-2308 or JGZ@NRC.GOV.

Sincerely,

/RA by Scott Flanders for/

Josephine Piccone, Deputy Director

Office of State and Tribal Programs

Enclosure(s): 

As stated
May 15, 2003

David J. Allard, CHP, Director

Bureau of Radiation Protection

 Department of Environmental Protection

Rachel Carson State Office Building

P.O.Box 8469

Harrisburg, PA. 17105-8469

Dear Mr. Allard:

As requested, we have reviewed the final Pennsylvania regulations, 25 PA. Code Chapters 215,

217, 219, 220, 224 - 226, 230 and 232, enclosed in your April 19, 2002 letter and which was

received by this office on May 2, 2002. These regulations were reviewed by comparison to the

equivalent NRC regulations in 10 CFR Parts 19, 20, 30, 31, 32, 33, 34, 35, 36, 39, 40, 61, 70,

71, 150 and the requirements of the 35 amendments identified in the enclosed State Regulation

Status (SRS) Data Sheet. In addition, we reviewed our January 5, 2001, letter to you that

addressed the proposed regulations and your response to our comments. We discussed our

review of the regulations with you on May 5, 2003. 

As a result of our review, we have identified 11 comments, as enclosed. We did not review

your incorporation of 10 CFR 35 because your incorporation references, documented in 25 PA.

Code Chapter 215, were for the old Part 35 medical rules. If the State would like to incorporate

this section by reference it is requested that you change your incorporation references and

submit this section again. Please note that we have limited our review to regulations required

for compatibility and/or health and safety. 

Please provide an amended final version of your rules showing the location of any changes

made by the State in response to our comments. If there are any comments which the State

believes are in error, the State should identify the section of their regulations that meet the

designated compatibility category and submit these sections to the NRC for review.

The SRS Data Sheet summarizes our knowledge of the Pennsylvania regulations. 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 Web Site:

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, or John Zabko

of my staff at (301) 415-2308 or JGZ@NRC.GOV.

Sincerely,

/By Scott Flanders for/

Josephine Piccone, Deputy Director

Office of State and Tribal Programs

Distribution:

DIR RF [3-62,3-63, 3-64] DCD SP05

Rblanton ASPO PDR (YES_)

DWhite, RSAO Busilton

Pennsylvania File Response to Incoming Document:: ML021270241 & ML031110208

DOCUMENT NAME: C:\MYFILES\Copies\3-62,63,64.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 STP STP OGC STP: DD

NAME LRakovan JZabko STreby JPiccone (SFlanders

for)**

DATE 4/ 11 /03* 4/24/03* 5/14/03* 5/15/03**

 ML031360008 OFFICIAL RECORD COPY
COMMENTS ON FINAL PENNSYLVANIA REGULATIONS

AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES

State

Regulation

NRC

Regulation

RATS

ID

Category Subject and Comments

 1 215.1 31.3 None B Certain Devices and Equipment

This section was excluded from the incorporation

by reference. 

This section needs to be included to meet

compatibility. 

2 230.4 71.10

(b)&(c)

None NRC Exemptions for low level material

This section was not excluded from the adoption

by reference, but should have been. The State

may not include sections reserved for the NRC in

its regulations. 

The State needs to remove this section from its

regulations.

3 215.1 71.47 None B External Radiation Standards For All

Packages

This section was excluded from the incorporation

by reference. 

This section needs to be included to meet

compatibility. 

4 230.3 71.83 None B Assumptions as to Unknown Properties

This section was excluded from the incorporation

by reference. 

This section needs to be included to meet

compatibility. 

 5 

 

230.3 71.22 None NRC General license: Fissile material, limited

quantity, Controlled Shipment

This section was not excluded from the adoption

by reference, but should have been. The State

may not include sections reserved for the NRC in

its regulations. 

The State needs to remove this section from its

regulations.
State

Regulation

NRC

Regulation

RATS

ID

Category Subject and Comments

6 215.1 40.33 None NRC Issuance of a Licence for a Uranium

Enrichment Facility

This section was not excluded from the adoption

by reference, but should have been. The State

may not include sections reserved for the NRC in

its regulations. 

The State needs to remove this section from its

regulations.

7 215.1 71.61 None NRC Special Requirements for Irradiated Nuclear

Fuel Shipments 

This section was not excluded from the adoption

by reference, but should have been. The State

may not include sections reserved for the NRC in

its regulations. 

The State needs to remove this section from its

regulations.

8 236 61.2 None B Definitions: Waste

The State definition is incomplete.

The State needs to match the Part 61 definition

to meet compatibility.

9 236 61.9 None C Deliberate misconduct

The State is missing this section and did not

incorporate this by reference.

The State needs to add this section to achieve

compatibility. 

10 236 61.30 None H&S Transfer of license

The State is missing this section.

The State needs to adopt these requirements to

achieve compatibility.

11 236 61.59 None H&S Institutional requirements

The State is missing the requirements of

61.59(b).

The State needs to include these requirements

to achieve compatibility. 
STATE REGULATION STATUS

State: Pennsylvania Tracking Ticket Num[All amendments reviewed except for 2002-2] Date: May 15, 2003

NRC Chronology Identification FR Notice

(Date Due For StateImplementation)

RATS ID

Propose/ Final (F

Rule / ML 

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

ML021270

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

ML021270

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

ML021270

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

ML021270

Eliminating the Recordkeeping Requirements for Departures from Manufacturer's InstructionsParts 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

ML021270

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

ML031110

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

ML021270

Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for MedicalUse-Parts 30, 32, 35

59 FR 61767; 59 FR 6524360 FR 322; (1/1/98)

1995-1 F

ML021270

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

ML021270
NRC Chronology Identification FR Notice

(Date Due For StateImplementation)

RATS ID

Propose/ Final (F

Rule / ML 

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

(3/1/98)

1995-3 F

ML021270

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

ML021270

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

ML021270

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

ML021270

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

ML021270

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

ML021270

One Time Extension of Certain Byproduct, Source and Special Nuclear Materials LicensesParts 30, 40, 70 61 FR 1109; (none) 1996-2 

Termination or Transfer of Licensed Activities: Recordkeeping Requirements-Parts 20, 30, 40,61, 70

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

ML021270

Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air ActPart 20 61 FR 65120; (1/9/00) 1997-1 FML021270

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

ML021270

Criteria for the Release of Individuals Administered Radioactive Material-Parts 20, 35 62 FR 4120; (5/29/00) 1997-3 F

ML021270

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

Licenses for Industrial Radiography and Radiation Safety Requirements for IndustrialRadiography Operations-Parts 30, 34, 71, 150

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

ML021270

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

ML021270

Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 UreaPart 30 62 FR 63634; (1/02/01) 1997-7 FML021270

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

(2/12/01)

1998-1 F

ML021270
NRC Chronology Identification FR Notice

(Date Due For StateImplementation)

RATS ID

Propose/ Final (F

Rule / ML 

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, p1995.

5. ADAMS ML Number6. These regulations are not required since authority over 11.e(2) material will not be transferred in the Agreement.

Self-Guarantee of Decommissioning Funding by Nonprofit and Non-Bond-Issuing LicenseesParts 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 IndustrialRadiographic Operations-Part 34

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

ML021270

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

ML021270

Transfer for Disposal and Manifests: Minor Technical Conforming Amendment-Part 20 63 FR 50127; (11/20/01) 1998-6 F

ML021270

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 Materialto 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

ML021270

Energy Compensation Sources for Well Logging and Other Regulatory Clarifications-Part 39 65 FR 20337; (5/17/03) 2000-1 F

ML021270

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

ML021270

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