March 2, 2011 

Roland G. Fletcher, Manager IV 

Radiological Health Program 

Air and Radiation Management Administration 

1800 Washington Boulevard 

Baltimore, MD 21230 

Dear Mr. Fletcher: 

We have reviewed the proposed changes to the Maryland regulations COMAR 26.12.01.01, 

received by our office on December 21, 2010. These regulations were reviewed by comparison 

to the equivalent Nuclear Regulatory Commission (NRC) rules in 10 CFR Parts 19, 20, 30, 31, 

32, 33, 35, 61 and 150 and the requirements of the two amendments and changes not 

associated with specific NRC amendments identified in the enclosed State Regulation Status 

(SRS) Data Sheet. We discussed our review of the regulations with Ray Manley on March 1, 

2011. 

As a result of our review, we have nine 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 Maryland 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 Maryland 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 Maryland 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. 

 
-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 Maria Arribas-Colon at (301) 415-6026 (Maria.ArribasColon@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 

 
[Concurrence Page] 

Enclosures: As stated 

Distribution: 

DIR RF (10-56) SUNSI Review Complete 

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

DJanda, RSAO : Non-Sensitive G Sensitive 

MBeardsley, POC 

MD File 

DOCUMENT NAME: 

Incoming Document: ML103550248 

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 MArribas KSchneider BJones DWhite TReis

DATE 02/15/11 02/ 15/11 02/28/11 03/02/11 03/02 /11 

ML110240017 OFFICIAL RECORD COPY Package ML110240010

 
 COMPATIBILITY COMMENTS ON MARYLAND PROPOSED REGULATIONS 

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

1 Section 

C.4(c)(3)(i) 

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

containing byproduct material 

It appears that Maryland never 

authorized the Licensing the 

Incorporation of Naturally Occurring 

and Accelerator-Produced 

Radioactive Material into Gas and 

Aerosol Detectors comparable to 

the provisions found in the 

Suggested State regulations in 

C.28(c). Since this area is reserved 

to NRC, Maryland needs to revise 

C.4(c)(3)(i) language as follows, 

including the information in the 

footnote: 

“Except for persons who 

manufacture, process, produce or 

initially transfer for sale or 

distribution gas and aerosol 

detectors containing byproduct 

material, any person is exempt from 

the requirements for a license set 

forth in Parts A, C through E, G, J, 

W, and X to the extent that such 

person receives, possesses, uses, 

transfers, owns, or acquires 

byproduct material in gas and 

aerosol detectors designed to 

protect life or property from fires and 

airborne hazards provided that 

detectors containing byproduct 

material shall have been 

manufactured, processed, 

produced, or initially transferred in 

accordance with a specific license 

issued by the NRC2/ pursuant to 10 

CFR 32.26; or an Agreement State 

pursuant to C.28c., which 

authorizes the initial transfer of the 

detectors to persons who are 

exempt from regulatory 

requirements. This exemption also 

covers gas and aerosol detectors 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

manufactured or distributed before 

November 30, 2007 in accordance 

with a specific license issued by an 

Agreement State under comparable 

provisions to 10CFR 32.26. 

authorizing distribution to persons 

exempt from regulatory 

requirements.”

Footnote 2/ Authority to transfer 

possession or control by the 

manufacturer, processor or producer 

of any equipment, device, commodity, 

or other product containing 

radioactive material whose 

subsequent possession, use, transfer, 

and disposal by all other persons are 

exempted from regulatory 

requirements may be obtained only 

from the NRC, Washington, D.C. 

20555

Maryland needs to incorporate the 

above change to Section C.4(c)(3)(i) 

in order to meet the Compatibility 

Category B designation assigned to 

10 CFR 30.20(a). 

2 Section 

C.26(g) 

'30.32(j) 2007-3 B Application for specific licenses 

Maryland regulation Section C.26(g) 

and C.26(g)(1) references “Section C” 

instead of “Part C.” Maryland needs 

to replace “Section” with “Part” when 

referencing to the entire Part. 

Maryland needs to make incorporate 

the above changes to Section C.29(g) 

in order to meet the Compatibility 

Category B designation assigned to 

10 CFR 30.32(j). 

3 Section 

C.22(l) 

'31.12 2007-3 C General license for certain items 

and self-luminous products 

containing radium-226 

Maryland needs to revise the 

references to be consistent with 

Maryland’s codification scheme. 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

In C.22(l)(2), Maryland should replace 

“Section D and J” with “Part D and J.” 

“Section C” should be revised to “Part 

C.” 

In C.22(l)(3)(iv), Maryland needs to 

change reference “Section C” to “Part 

C.” 

In C.22(l)(4), Maryland needs to 

change the reference from “Section 

C.22” to “Section C.22(l)(1).” 

Maryland needs to make the above 

changes to Section C.22(l) in order to 

meet the Compatibility Category C 

designation assigned to 10 CFR 

31.12. 

4 Section 

C.28(o) 

'32.59 2007-3 B Same: Leak testing of each source 

Maryland regulation Section C.28(o) 

references C.22(d) as equivalent to 

10 CFR 31.8. In existing Maryland 

regulation, C.22(g) is equivalent to 10 

CFR 31.8. In C.28(o), Maryland 

needs to change the reference from 

“Section C.22(d)” to “Section C.22(g).”

Maryland needs to make the above 

changes in Section C.28(o) in order to 

meet the Compatibility Category B 

designation assigned to 10 CFR 

32.59.

5 Section C.28 

(j)(1)(ii) (a), 

(c), (d), (e) 

and (j)(2) 

'32.72 (a)(2)(i), 

(iii), (iv), (v), & (b) 

2007-3 B Manufacture, preparation, or 

transfer for commercial 

distribution of radioactive drugs, 

containing byproduct material for 

certain in vitro clinical or 

laboratory testing under general 

license 

In C.28(j)(1)(ii)(a), Maryland omits: “... 

as the owner or operator of a drug 

establishment that engages in the 

manufacture, preparation, 

propagation, compounding, or 

processing of a drug under 21 CFR 

207.20(a);...” after “Registered or 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

licensed with the U.S. Food and Drug 

Administration (FDA) as a drug 

manufacturer;...” 

Maryland needs to incorporate the 

above to Section C.28(j)(1)(ii)(a) in 

order to meet the Compatibility 

Category B designation assigned to 

10 CFR 32.72(a)(2)(i). 

6 Section 

D.301 (d) 

'20.1301 (a) and 

(c) 

Not 

Applicable

A Dose limits for individual members 

of the public 

Maryland on Section D.301(d) states: 

“Notwithstanding paragraph (a)(1) of 

this section, ...” The correct 

reference in this Section per Maryland 

codification scheme is (a)(i). 

Maryland needs to list the correct 

reference to this section. 

Maryland needs to make the above 

change to Section D.301(d) in order 

to meet the Compatibility Category A 

designation assigned to 10 CFR 

20.1301(c). 

7 Section 

C.28(j) (2)(i) 

& (2)(ii)(b) 

'32.72 (b)(1)& 

(b)(2)(ii) 

Not 

Applicable

B Manufacture, preparation, or 

transfer for commercial 

distribution of radioactive drugs 

containing byproduct material for 

medical use under Part 35 

Maryland regulations on Section 

C.28(j)(2)(i) states that: “May prepare 

radioactive drugs for medical use, as 

defined in Sec. G.2, provided...” 

instead of “Sec A.2).” The definition 

of authorized nuclear pharmacist in 

Maryland regulations is located in 

Section A.2, not Section G.2. 

Maryland needs to list the correct 

reference in this section. 

Maryland needs to make the above 

change to Section C.28(j)(2)(i) in 

order to meet the Compatibility 

Category B designation assigned to 

10 CFR 32.72(b)(1). 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

8 Section G.80 '35.80 Not 

Applicable

H&S Provision of mobile medical 

service 

Maryland proposed regulation would 

delete language similar to 10 CFR 

35.80(a)(3) which addresses the need 

to check survey instruments for 

proper operations with a dedicated 

check source before use at each 

client’s address. 

Maryland needs to retain the 

requirements in the existing 

G.80(a)(3) in order to meet the 

Compatibility Category H&S 

designation assigned to 10 CFR 

35.80. 

9 Section 

D.1208 

'35.3045 Not 

Applicable

C Report and notification of a 

medical event 

Maryland omits equivalent language 

to 35.3045(b). Maryland needs to add 

equivalent language into their 

regulations. 

Maryland needs to incorporate the 

above in order to meet the 

Compatibility Category C designation 

assigned to 10 CFR 35.3045. 
STATE REGULATION STATUS

State: Maryland 

 Tracking 

[2 amendment(s) and changes not associated with RATS ID reviewed Date: Mare identified by a i 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 No Comments 

09/09/1995 

MarylaRegula1997-5

1991-2 ASNT Certification of Radiographers 

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

none Final No Comments 

09/09/1995 

MarylaRegula1997-5

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 

02/28/1997 

1991-4 Notification of Incidents 

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

10/15/1994 Final No Comments 

04/15/1998 

1992-1 Quality Management Program and Misadministrations 

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

01/27/1995 Final No Comments 

09/09/1995 

MarylaRegula2002-2

1992-2 Eliminating the Recordkeeping Requirements 

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

none Not Required Not Required These 

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 No Comments 

10/19/1995 
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 No Comments 

03/20/1997 

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

Part 61 58 FR 33886 

07/22/1996 Not Applicable1 Not Applicable Maryla

subjecSECY

1994-1 Self-Guarantee as an Additional Financial Mechanism 

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

none Not Required Not Required 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 Maryla

regulaAgree

1994-3 Timeliness in Decommissioning Material Facilities 

Parts 30, 40, 70 59 FR 36026 

08/15/1997 Final No Comments 

08/08/2000 

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 

08/08/2000 

1995-2 Frequency of Medical Examinations for Use of 

Respiratory Protection Equipment Part 20 60 FR 7900

03/13/1998 Final No Comments 

11/03/1997 

1995-3 Low-Level Waste Shipment Manifest Information and 

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

03/01/1998 Final No Comments 

12/28/1997 

1995-4 Performance Requirements for Radiography Equipment 

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

06/30/1998 Final No Comments 

08/08/2000 

MarylaRegula1997-5
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 

08/08/2000 

1995-6 Clarification of Decommissioning Funding Requirements 

Parts 30, 40, 70 60 FR 38235 

11/24/1998 Final No Comments 

08/08/2000 

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 No Comments 

08/08/2000 

MarylaRegula2002-2 

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 No Comments 

08/08/2000 

MarylaRegula2004-1

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 No Comments 

08/08/2000 

1997-1 Resolution of Dual Regulation of Airborne Effluents of 

Radioactive Materials; Clean Air Act Part 20 61 FR 65120 

01/9/2000 Final 

ML051380408 

No Comments 06/27/2005 ML051800055 

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 

ML051380408 

No Comments 06/27/2005 ML051800055 
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 

ML021120426 

No Comments 05/10/2002 ML021340513 

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

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 

ML021120426 

No Comments 05/10/2002 ML021340513 

1997-6 Radiological Criteria for License Termination 

Parts 20, 30, 40, 70 62 FR 39057 

08/20/2000 Final 

ML021120426 

No Comments 05/10/2002 ML021340513 

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 

ML051380408 

No Comments 06/27/2005 ML051800055 

1998-1 Deliberate Misconduct by Unlicensed Persons 

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

02/12/2001 Final 

ML051380408 

No Comments 06/27/2005 ML051800055 

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 

requireCompa
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 Final 

ML051100241

No Comments 05/13/2005 ML051360003 

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 

ML051100241 

No Comments 05/13/2005 ML051360003 

1998-6 Transfer for Disposal and Manifests: Minor Technical 

Conforming Amendment Part 20 63 FR 50127 

11/20/2001 Final 

ML051100241 

No Comments 05/13/2005 ML051360003 

1999-1 Radiological Criteria for License Termination of Uranium 

Recovery Facilities Part 40 64 FR 17506 

06/11/2002 Not Applicable Not applicable Maryla

regulaAgree

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 

ML051100241 

No Comments 05/13/2005 ML051360003 

2000-1 Energy Compensation Sources for Well Logging and 

Other Regulatory Clarifications Part 39 65 FR 20337 

05/17/2003 Final 

ML051100241 

No Comments 05/13/2005 ML051360003 

2000-2 New Dosimetry Technology 

Parts 34, 36, 39 65 FR 63750 

01/08/2004 Final 

ML071710580 

No Comments 09/04/2007 ML072470495 
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 Final 

ML071980288 

No Comments 08/03/2007 ML072210120 

2002-1 Revision of the Skin Dose Limit 

Part 20 67 FR 16298 

04/05/2005 Final 

ML071710580 

No Comments 09/04/2007 ML072470495 

2002-2 Medical Use of Byproduct Material 

Parts 20, 32, 35 67 FR 20249 

10/24/2005 Final 

ML083290007 

No Comments 12/23/2008 ML083460488 

2003-1 Financial Assurance for Materials Licensees 

Parts 30, 40, 70 68 FR 57327 

12/03/2006 Final 

ML071710580 

No Comments 09/04/2007 ML072470495 

2004-1 Compatibility With IAEA Transportation Safety Standards 

and Other Transportation Safety Amendments Part 71 69 FR 3697 

10/01/2007 Final 

ML093500525 

No Comments 01/27/2010 ML100140061 

2005-1 Security Requirements for Portable Gauges Containing 

Byproduct Material Part 30 70 FR 2001 

07/11/2008 Final 

ML083290007 

No Comments 12/23/2008 ML083460488 

2005-2 Medical Use of Byproduct Material - Recognition of 

Specialty Boards Part 35 70 FR 16336; 71 FR 1926 

04/29/2008 Final 

ML083290007 

No Comments 12/23/2008 ML083460488 

2005-3 Increased Controls for Risk-Significant Radioactive 

Sources (NRC Order EA-05-090)

70 FR 72128 

12/01/2005 License Condition 

ML053040172 

No Comments 11/01/2005 ML053050373 

2006-1 Minor Amendments 

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

03/27/2009 Final 

ML093500525 

No Comments 01/27/2010 ML100140061 
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 Final 

ML093500525 

No Comments 01/27/2010 ML100140061 

2006-3 National Source Tracking System 

Part 20 71 FR 65685, 72 FR 59162 

01/31/2009 Proposed 

ML082108398 License Condition ML083390004 

No Comment 09/03/2008 ML082310168 No Comment 12/11/2008 ML083390024 

2007-1 Medical Use of Byproduct Material - Minor Corrections 

and Clarifications Parts 32 and 35 72 FR 45147, 54207 

10/29/2010 Final 

ML093500525 

No Comments 01/27/2010 ML100140061 

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 

ML101690102 

No Comments 07/29/2010 ML101800106 

*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 

ML103550248 

Comments 03/02/2011 ML110240010 

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 

ML081160371 

No Comments 05/02/2008 ML081230186 

*2008-1 Occupational Dose Records, Labeling Containers, and 

Total Effective Dose Equivalent Parts 19, 20 72 FR 68043 

02/15/2011 Proposed 

ML103550248 

No Comments 03/02/2011 ML110240010 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

2009-1 Medical Use of Byproduct Material – Authorized User 

Clarification Part 35 74 FR 33901 

09/28/2012 

N/A 10 CFR 20.1301, 32.72, 35.80 and 35.3045 N/A Proposed 

ML103550248 

Comments 03/02/2011 ML110240010 

1 IMPEP Team: verify that Maryland does not have any licensees subject to these regulations during each review.