January 19, 2011 

Mr. Robert L. Gallaghar, Acting Director 

Radiation Control Program 

Bureau of Environmental Health 

Department of Public Health 

529 Main Street 

Charlestown, MA 02129 

Dear Mr. Gallaghar: 

We have reviewed the proposed changes to the Massachusetts Regulations for the Control of 

Radiation: 105 CMR 120.005, 120.100, 120.200, and 120.750, received by our office on 

December 2, 2010. These regulations were reviewed by comparison to the equivalent Nuclear 

Regulatory Commission (NRC) rules in 10 CFR Parts 19, 20, 30, 31, 32, 35, and 150 and the 

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

Data Sheet. We discussed our review of the regulations with you on January 13, 2011. 

As a result of our review, we have seven 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 Massachusetts 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 Massachusetts 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 Massachusetts 

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 Torre Taylor at (301) 415-7900 (torre.taylor@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 (10-54) SUNSI Review Complete 

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

DJanda, RSAO : Non-Sensitive G Sensitive 

MBeardsley, POC 

MA File 

DOCUMENT NAME: G:\DMSSA\SAISB\REGULATION TOOLBOX\STATES\MASSACHUSETTS\10-54\10-54.DOCX 

Incoming Document: ML103350064 

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 NColeman/TTaylor KSchneider/TMT BJones DWhite TReis

DATE 12/29/10 12/29/10 01/11/11 01/19/11 01/19/11 

ML 103630206 OFFICIAL RECORD COPY Package ML103630079
 COMPATIBILITY COMMENTS ON Massachusetts PROPOSED REGULATIONS 

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

1 120.104 

(C)(1) 

30.15 2007-2 B Certain items containing byproduct 

material 

In regulation 102.104(c)(1)(a)(8), the 

term “intact” needs to be inserted 

between “per timepiece in“ and 

“timepiece acquired.” 

In regulation 102.104(C)(1)(a)(8), the 

word “acquired” needs to be changed 

to “manufactured.” 

Massachusetts needs to make the 

above changes in order to meet the 

Compatibility Category B designation 

assigned to 10 CFR 30.15. 

2 120.005 20.1003 2008-1 A Definition: Total Effective Dose 

Equivalent (TEDE) 

Massachusetts needs to remove the 

term “deep” from “effective deep dose 

equivalent”. 

Massachusetts needs to move “for” 

inside of the parenthesis to read 

“...(for internal exposure).” 

Massachusetts needs to make the 

above changes in order to meet the 

Compatibility Category A designation 

assigned to 10 CFR 20.1003. 

3 120.546 35.190 2009-1 B Training for uptake, dilution, and 

excretion studies 

In 120.546(C)(1)(b), Massachusetts 

needs to revise “120 546” to 

“120.546.” 

Massachusetts needs to make the 

above change in order to meet the 

Compatibility Category B designation 

assigned to 10 CFR 35.190. 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

4 120.551 35.290 2009-1 B Training for imaging and 

localization studies 

In 120.551(C)(1)(b), Massachusetts 

needs to revise the regulation 

references to read “105 CMR 

120.528, 120.551, or 120.556 and 

120.551(c)(1)(b)7....” 

Massachusetts needs to make the 

above change in order to meet the 

Compatibility Category B designation 

assigned to 10 CFR 35.290. 

5 120.557 35.392 2009-1 B Training for the oral administration 

of sodium iodide I-131 requiring a 

written directive in quantities 

less than or equal to 1.22 

gigabecquerels (33 millicuries) 

In 120.557(B), Massachusetts needs 

to add 105 CMR 120.556(B)(1)(b)7.a. 

and 105 CMR 120.558. 

In 120.557(C)(2), Massachusetts 

needs to add “120.557” between 

“120.556” and “120.558.” 

In 120.557(C)(2), Massachusetts 

needs to add “120.556(B)(1)(b).7.a. 

and”, to the last sentence, after “...in 

administering dosages as specified in 

...”. 

In 120.557(C)(3), Massachusetts 

needs to add “120.556(B)(1)(b)7.a. 

and”, to the last sentence, after 

“...who meets the requirements of...”. 

Massachusetts needs to make the 

above changes in order to meet the 

Compatibility Category B designation 

assigned to 10 CFR 35.392. 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

6 120.558 35.394 2009-1 B Training for the oral administration 

of sodium iodide I-131 requiring a 

written directive in quantities 

greater than 1.22 gigabecquerels 

(33 millicuries) 

In 120.558(C)(2)(d), Massachusetts 

needs to remove the term “unsealed” 

before “byproduct material”. 

Massachusetts needs to make the 

above change in order to meet the 

Compatibility Category B designation 

assigned to 10 CFR 35.394. 

7 120.567 35.491 2009-1 B Training for ophthalmic use of

strontium-90 

In 120.567(B)(3), Massachusetts 

needs to remove reference to 

120.567(A). 

Massachusetts needs to make the 

above change in order to meet the 

Compatibility Category B designation 

assigned to 10 CFR 35.491. 

 
STATE REGULATION STATUS

State: Massachusetts 

 Tra

[3 amendment(s) reviewed is identified by a i Da

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 

03/03/1997 

MassaRegula1997-5

1991-2 ASNT Certification of Radiographers 

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

none Not Required Not Required Massa

Regula1997-5

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 

03/03/1997 

1991-4 Notification of Incidents 

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

10/15/1994 Final No Comments 

03/03/1997 

1992-1 Quality Management Program and Misadministrations 

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

01/27/1995 Final No Comments 

03/03/1997 

MassaRegula2002-2

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 

03/03/1997 
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 

03/03/1997 

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

Part 61 58 FR 33886 

07/22/1996 Final No Comments 

03/03/1997 

1994-1 Self-Guarantee as an Additional Financial Mechanism 

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

none Final No Comments 

03/03/1997 

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 Massa

to reguAgree

1994-3 Timeliness in Decommissioning Material Facilities 

Parts 30, 40, 70 59 FR 36026 

08/15/1997 Final 

ML062980638 

No Comments 11/30/2006 ML063380019 

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 

09/21/1999 

1995-2 Frequency of Medical Examinations for Use of 

Respiratory Protection Equipment Part 20 60 FR 7900

03/13/1998 Final 

ML062980638 

No Comments 11/30/2006 ML063380019 

1995-3 Low-Level Waste Shipment Manifest Information and 

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

03/01/1998 Final 

ML062980638 

No Comments 11/30/2006 ML063380019 

1995-4 Performance Requirements for Radiography Equipment 

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

06/30/1998 Not Required Not Required Massa

Regula1997-5
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 

ML062980638 

No Comments 11/30/2006 ML063380019 

1995-6 Clarification of Decommissioning Funding Requirements 

Parts 30, 40, 70 60 FR 38235 

11/24/1998 Final 

ML062980638 

No Comments 11/30/2006 ML063380019 

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 

09/21/1999 

MassaFinal RID: 200

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 

09/21/1999 

MassaFinal RID: 200

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 

09/21/1999 

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 

09/21/1999 

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 

ML062980638 

No Comments 11/30/2006 ML063380019 
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 

ML062980638 

No Comments 11/30/2006 ML063380019 

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 No Comments 

09/21/1999 

1997-6 Radiological Criteria for License Termination 

Parts 20, 30, 40, 70 62 FR 39057 

08/20/2000 Final 

ML062980638 

No Comments 11/30/2006 ML063380019 

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 No Comments 

09/21/1999 

1998-1 Deliberate Misconduct by Unlicensed Persons 

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

02/12/2001 Final 

ML062980638 

No Comments 11/30/2006 ML063380019 

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 

requireCompaMassaRegula2002-2
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 Final 

ML062980638 

No Comments 11/30/2006 ML063380019 

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 

ML062980638 

No Comments 11/30/2006 ML063380019 

1998-6 Transfer for Disposal and Manifests: Minor Technical 

Conforming Amendment Part 20 63 FR 50127 

11/20/2001 Final 

ML062980638 

No Comments 11/30/2006 ML063380019 

1999-1 Radiological Criteria for License Termination of Uranium 

Recovery Facilities Part 40 64 FR 17506 

06/11/2002 Not Applicable Not Applicable Massa

to reguAgree

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 

ML062980638 

No Comments 11/30/2006 ML063380019 

2000-1 Energy Compensation Sources for Well Logging and 

Other Regulatory Clarifications Part 39 65 FR 20337 

05/17/2003 Final 

ML062980638 

No Comments 11/30/2006 ML063380019 

2000-2 New Dosimetry Technology 

Parts 34, 36, 39 65 FR 63750 

01/08/2004 Final 

ML062980638 

No Comments 11/30/2006 ML063380019 
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 

ML062980638 

No Comments 11/30/2006 ML063380019 

2002-1 Revision of the Skin Dose Limit 

Part 20 67 FR 16298 

04/05/2005 Final 

ML062980638 

No Comments 11/30/2006 ML063380019 

2002-2 Medical Use of Byproduct Material 

Parts 20, 32, 35 67 FR 20249 

10/24/2005 Final 

ML062980638 

No Comments 11/30/2006 ML063380019 

2003-1 Financial Assurance for Materials Licensees 

Parts 30, 40, 70 68 FR 57327 

12/03/2006 Final 

ML102850241 

No Comments 11/10/2010 ML102990077 

2004-1 Compatibility With IAEA Transportation Safety Standards 

and Other Transportation Safety Amendments Part 71 69 FR 3697 

10/01/2007 Final 

ML102850241 

Comments 11/10/2010 ML102990077 

2005-1 Security Requirements for Portable Gauges Containing 

Byproduct Material Part 30 70 FR 2001 

07/11/2008 Final 

ML102850241 

No Comments 11/10/2010 ML102990077 

2005-2 Medical Use of Byproduct Material - Recognition of 

Specialty Boards Part 35 70 FR 16336; 71 FR 1926 

04/29/2008 Proposed 

ML1010307800 

Comments 06/23/2010 ML101250283 

2005-3 Increased Controls for Risk-Significant Radioactive 

Sources (NRC Order EA-05-090)

70 FR 72128 

12/01/2005 License Condition 

ML080110677 

No Comments 10/04/2005 ML052780024 

2006-1 Minor Amendments 

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

03/27/2009 Proposed 

ML1010307800 

Comments 06/23/2010 ML101250283
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 License Condition 

ML070360500 

No Comments 02/16/2007 ML070470063 

2006-3 National Source Tracking System 

Part 20 71 FR 65685, 72 FR 59162 

01/31/2009 Final 

ML102850241 License Condition ML082760641 

No Comments 11/10/2010 ML102990077 No Comments 10/20/2008 ML082800024 

2007-1 Medical Use of Byproduct Material - Minor Corrections 

and Clarifications Parts 32 and 35 72 FR 45147, 54207 

10/29/2010 Proposed 

ML1010307800 

No Comments 06/23/2010 ML101250283 

*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 

ML103350064 

Comments 01192011 ML103630079 

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 

ML1010307800 

Comments 06/23/2010 ML101250283 

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 

ML080800501 

No Comments 04/14/2008 ML081050505 

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

Total Effective Dose Equivalent Parts 19, 20 72 FR 68043 

02/15/2011 Proposed 

ML103350064 

Comments 01/19/2011 ML103630079 
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 Proposed 

ML103350064 

Comments 01/19/2011 ML103630079