January 21, 2005

Mr. Robert Walker, Director

Executive Office of Health and Human Services

Department of Public Health

Radiation Control Program

90 Washington Street

Dorchester, MA. 02121

Dear Mr. Walker: 

We have reviewed the proposed changes to the Massachusetts regulations, “Massachusetts

Regulations for the Control of Radiation”, received by our office on November 23, 2004. Our

review and comments are in response to the State’s request for Nuclear Regulatory

Commission (NRC) evaluation of the changes to Massachusetts’ radiation control rules that

incorporated the amendments identified on the States Regulation Status (SRS) Data Sheet. 

These regulations were reviewed by comparison to the equivalent NRC rules in 10 CFR Parts

30, 40, 70, 20, 61, 19, 150, 71, 34, 36, 35, 39, 31, 32 and the requirements of the 

16 amendments identified in the enclosed SRS. We discussed our review of the regulations

with Salifu Dakubu on December 22, 2004.

As a result of our review, we have 13 comments and two editorial suggestions. Under our

current procedure, a finding that a State regulation meets the compatibility and health and

safety categories of the equivalent NRC regulation may only be made based on a review of the

final State regulation. Please provide a final amended version of your rules showing the

location of any changes made 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. Please note that we have limited our review to

regulations required for compatibility and/or health and safety, but have determined that if these

regulations are adopted, incorporating our comments and without 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.

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 STP website: http://www.hrsd.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 Shawn

Rochelle Smith of my staff at (301) 415-2620 or srs3@nrc.gov. 

Sincerely,

\RA By K.N. Schneider For\

Josephine M. Piccone, Deputy Director

Office of State and Tribal Programs

Enclosures: 

As stated
January 21, 2005

Mr. Robert Walker, Director

Executive Office of Health and Human Services

Department of Public Health

Radiation Control Program

90 Washington Street

Dorchester, MA. 02121

Dear Mr. Walker: 

We have reviewed the proposed changes to the Massachusetts regulations, “Massachusetts

Regulations for the Control of Radiation”, received by our office on November 23, 2004. Our

review and comments are in response to the State’s request for Nuclear Regulatory Commission

(NRC) evaluation of the changes to Massachusetts’ radiation control rules that incorporated the

amendments identified on the States Regulation Status (SRS) Data Sheet. These regulations

were reviewed by comparison to the equivalent NRC rules in 10 CFR Parts 30, 40, 70, 20, 61, 19,

150, 71, 34, 36, 35, 39, 31, 32 and the requirements of the 16 amendments identified in the

enclosed SRS. We discussed our review of the regulations with Salifu Dakubu on 

December 22, 2004.

As a result of our review, we have 13 comments and two editorial suggestions. Under our current

procedure, a finding that a State regulation meets the compatibility and health and safety

categories of the equivalent NRC regulation may only be made based on a review of the final State

regulation. Please provide a final amended version of your rules showing the location of any

changes made 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. Please note that we have limited our review to regulations required for

compatibility and/or health and safety, but have determined that if these regulations are adopted,

incorporating our comments and without 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.

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 STP website: http://www.hrsd.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 Shawn

Rochelle Smith of my staff at (301) 415-2620 or srs3@nrc.gov. 

Sincerely,

\RA By K.N. Schneider For\

Josephine M. Piccone, Deputy Director

Office of State and Tribal Programs

Enclosures: As stated

Distribution:

DIR RF[4-336] DCD (SP05) PDR (YES_T) Response to Incoming Document: ML043510327

Sheri Minnick/Duncan White, RSAO James Myers, ASPO Massachusetts File Document

Name:C:\MyFiles\Copies\4-336.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 SSmith WRautzen STreby KNSchneider for

JMPiccone

DATE 12/29/04* 1/4/05* 1/19/05* 1/21/05*

ML050250339 OFFICIAL RECORD COPY
COMPATIBILITY COMMENTS FOR

PROPOSED MASSACHUSETTS REGULATIONS

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

1 120.226 20.1502 1998-5 H&S Conditions requiring individual

monitoring of external 

and internal occupational dose

Paragraph (b)(3) of 10 CFR Part

20.1502 is not included. 

The State needs to include paragraph

(b)(3) of 10 CFR Part 20.1502 to

meet the essential objectives for

compatibility Category H&S.

2 Omitted 36.23 1998-5 H&S Access Control

The State omitted this provision.

The State needs to include this

provision to meet the essential

objectives for compatibility Category

H&S.

3 120.282 20.2202 1998-5 C Notification of incidents

In paragraph (a)(1)(ii) of 10 CFR Part

20.2202, “eye” should be replaced

with “lens”.

The State needs to adopt this revision

to meet the essential objectives for

compatibility Category C.

4 120.005 20.1003 1999-3 B Definitions: Supplied Air

Respirator

The definition for supplied air

respirator was omitted.

The State needs to include this

definition to meet the essential

objectives for compatibility Category

B.

5 Omitted 30.31 2001-1 C Types of Licenses

The State omitted the requirements of

10 CFR Part 30.31.

The State needs to include these

requirements to meet the essential

objectives for compatibility Category

C.
COMPATIBILITY COMMENTS FOR

PROPOSED MASSACHUSETTS REGULATIONS

6 Omitted 20.1301 2002-2 A Dose limits for individual members

of the public

The State omitted the requirements of

10 CFR Part 20.1301.

The State needs to include these

requirements to the essential

objectives for compatibility Category

A.

7 Omitted 32.72 2002-2 B Manufacture, preparation, or

transfer for commercial

distribution of radioactive drugs

containing byproduct material for

medical use under Part 35

The State omitted the requirements of

10 CFR 32.72.

The State needs to adopt these

requirements to meet the essential

objectives for compatibility Category

B.

8 Omitted 32.74 2002-2 B Manufacture and distribution of

sources or devices containing

byproduct material for medical use

The State omitted the requirements of

10 CFR Part 32.74

The State needs to adopt these 

requirements to meet the essential

objectives for compatibility Category

B.

9 120.502 35.2 2002-2 C Definitions: Medical Use

In the State definition for “Medical

Use”, the word, “material”, is missing

after radioactive.

The State needs to adopt this revision

to meet the essential objectives for

compatibility Category C. 
COMPATIBILITY COMMENTS FOR 

PROPOSED MASSACHUSETTS REGULATIONS

10 120.526 35.55 2002-2 B Training for an authorized nuclear

pharmacist

In Section 120.526(B)(2) of the State

regulations, it states that the

individual should be able to

independently operate a nuclear

pharmacy. 10 CFR Part 35.55 states

that the individual should be able to

operate independently as an

authorized nuclear pharmacist. 

The State needs to adopt the

language in 10 CFR 35.55 to meet

the essential objectives for

compatibility Category B. 

11 Omitted 35.433 2002-2 H&S Decay of strontium-90 sources for

ophthalmic treatments

The State has omitted the

requirements of 10 CFR Part 35.433.

The State needs to include these

requirements to meet the essential

objectives for compatibility Category

H&S.

12 120.587 35.690 2002-2 B Training for use of remote

afterloader units, teletherapy units,

and gamma stereotactic

radiosurgery units

The State omitted 10 CFR Part

35.690 (b)(1)(ii)(E) and (F).

The State needs to adopt the

requirements of 10 CFR Part 35.690

(b)(1)(ii)(E) and (F) to meet the

essential objectives for compatibility

Category B. 

13 Omitted 61.80 1995-3 C Maintenance of records, reports,

and transfers

The State omitted the requirements of

10 CFR Part 61.80.

The State needs to adopt the

requirements of 10 CFR Part 61.80 to

meet the essential objectives for

compatibility Category C. 
Editorial Suggestions

1. In the first paragraph of section 120.558, “greater” is missing between “quantities” and “than”.

2. In the first paragraph of section 120.577, “teletherapy unit” should be replaced with “remote

after loader”. 
STATE REGULATION STATUS

State: Massachusetts [16 amendments reviewed are identified by a i Tracking Ticket N

at the beginning of the equivalent NRC regulation.] Date: January 21, 

NRC Chronology Identification FR Notice

(Date Due For StateImplementation)

RATS ID

Proposed (PFinal (F)2Rul

ML #5

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

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

Quality Management Program and Misadministrations-Part 35 56 FR 34104; (1/27/95) 1992-1 F Eliminating the Recordkeeping Requirements for Departures from Manufacturer'sInstructions-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 

Licensing and Radiation Safety Requirements for Irradiators-Part 36 58 FR 7715; (7/1/96) 1993-2 F 

Definition of Land Disposal and Waste Site QA Program-Part 61 58 FR 33886; (7/22/96) 1993-3 F 

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

(none)

1994-1 F 

Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPA Standards-Part40

59 FR 28220; (7/1/97) 1994-2

i Timeliness in Decommissioning Material Facilities-Parts 30, 40, 70 59 FR 36026; (8/15/97) 1994-3 P

ML04351032

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

59 FR 61767; 59 FR 65243;60 FR 322; (1/1/98)

1995-1 F 

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

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

(3/1/98)

1995-3 P

ML04351032

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

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

ML04351032
NRC Chronology Identification FR Notice

(Date Due For StateImplementation)

RATS ID

Proposed (PFinal (F)2Rul

ML #5

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

ML04351032

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

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 

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 

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

i 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 P

ML04351032

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

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 

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

ML04351032

Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea-Part 30 

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

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

(2/12/01)

1998-1 P

ML04351032

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 

i Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial

Radiographic Operations-Part 34

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

ML04351032

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

(10/26/01)

1998-5 P

ML04351032
NRC Chronology Identification FR Notice

(Date Due For StateImplementation)

RATS ID

Proposed (PFinal (F)2Rul

ML #5

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

ML04351032

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 ByproductMaterial to Provide Requested Information-Part 31

64 FR 42269; (none) 1999-2

i Respiratory Protection and Controls to Restrict Internal Exposure-Part 20 64 FR 54543; 64 FR 55524;

(2/2/03)

1999-3 P

ML04351032

i Energy Compensation Sources for Well Logging and Other Regulatory Clarifications-Part

39

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

ML04351032

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

ML04351032

i Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct

Material-Parts 30, 31, 32

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

ML04351032

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

ML04351032

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

ML04351032

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

Compatibility With IAEA Transportation Safety Standards and Other TransportationSafety Amendments – Part 71.

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

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

and Compatibility of Agreement State Programs.” III.1. Time Frame for Adoption of Compatible State Regulations, p.6, SECY-95-

5. ADAMS ML Number.