September 15, 2010 

Stephen M. Gavitt, CHP, Director 

Bureau of Environmental Radiation Protection 

New York State Department of Health 

547 River Street 

Troy, New York 12180 

Dear Mr. Gavitt: 

We have reviewed the proposed changes to the New York State Department of Health 

regulations, 16.113, 16.114, 16.2 and 16.103, received by our office on July 26, 2010. These 

regulations were reviewed by comparison to the equivalent Nuclear Regulatory Commission 

(NRC) rules in 10 CFR Parts 20, 30, 40, 61, 70 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 Robert Dansereau on September 14, 2010. 

As a result of our review, we have four 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 New York State 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 New York State 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 New York 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. 

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 Antonio Dias at 301-415-6805 (antonio.dias@nrc.gov). 

Sincerely, 

/RA A.D. White for/ 

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 (10-33) SUNSI Review Complete 

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

DJanda, RSAO : Non-Sensitive G Sensitive 

MBeardsley, POC 

NY File 

DOCUMENT NAME: G:\DMSSA\SAISB\REGULATION TOOLBOX\States\New York\10-33 NY DOH 

Incoming Document: ML102020009 

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 OGC ASPB:BC MSSA:DD 

NAME ADias / kns KSchneider BJones DWhite TReis

DATE 09/07/10 09/07/10 09/13/10 09/15/10 09/15/10 

ML OFFICIAL RECORD COPY Package ML102370215
 COMPATIBILITY COMMENTS ON NEW YORK DEPARTMENT OF HEALTH (DOH) 

PROPOSED REGULATIONS 

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

1 16.113(g)

 

20.1401(d) 1997-6 C General provisions and scope 

New York DOH has omitted the 

requirements of 20.1401(d). This 

requirement mandates that the peak 

annual TEDE be calculated for the 

first 1,000 years after termination of 

the license. This requirement is 

important in determining the potential 

exposure to members of the public. 

New York DOH needs to add this 

paragraph to 16.113(g) to meet the 

Compatibility Category C designation 

assigned to 10 CFR 20.1401. 

2 16.103(d) 20.1406 1997-6 C Minimization of contamination 

New York DOH has omitted the 

requirements of 20.1406. This 

requirement mandates the licensee 

describe how the facility design and 

procedures for operations will 

minimize, to the extent practicable, 

contamination of the facility and the 

environment, facilitate eventual 

decommissioning, and minimize, to 

the extent practicable, the generation 

of radioactive waste. 

New York DOH needs to add this 

requirement to 16.103(d) to meet the 

Compatibility Category C designation 

assigned to 10 CFR 20.1406. 

3 16.114 (a) & 

(b) 

40.36 2003-1 H&S Financial assurance and 

recordkeeping for 

decommissioning 

New York DOH uses “byproduct” 

material instead of “radioactive” 

material within this section. This 

creates a gap, since source material 

will not be included under these 

requirements. New York DOH should 

change all references to “Byproduct 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

Material” to “Radioactive Material.” 

Also, New York DOH omits an 

equivalent section to 10 CFR 40.36 

which requires financial assurance 

and recordkeeping for 

decommissioning requirements for 

“...a specific license authorizing the 

possession and use of more than 

100mCi of source material in a readily 

dispersible form ...” and for “...a 

specific license authorizing the 

possession and use of quantities of 

source material greater than 10mCi 

but less than or equal to 100mCi in a 

readily dispersible form...”. 

New York DOH needs to make the 

above changes to16.114 and Table 

16-A to meet the Compatibility 

Category H&S designation assigned 

to 10 CFR 40.36. 

4 16.114 70.25 2003-1 H&S Financial assurance and 

recordkeeping for 

decommissioning 

NYDOH uses “byproduct” material 

instead of “radioactive” material within 

this section. This creates a gap, since 

special material will not be included 

under these requirements. NYDOH 

should change all references to 

“Byproduct Material” to “Radioactive 

Material.” 
STATE REGULATION STATUS

State: New York State Health Department 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 NYSH

Regula1997-5 AdoptemergeML092

1991-2 ASNT Certification of Radiographers 

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

none Not Required Not Required These 

requireCompa

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 Comments 

12/24/1997 

AdoptemergeML092

1991-4 Notification of Incidents 

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

10/15/1994 Final No Comments 

01/28/2000 

AdoptemergeML092

1992-1 Quality Management Program and Misadministrations 

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

01/27/1995 NYSH

Regula2002-2

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 

01/28/2000 

AdoptemergeML092
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 

01/28/2000 

AdoptemergeML092

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

Part 61 58 FR 33886 

07/22/1996 Not Applicable Not Applicable NYSH

regulaof the 

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 NYSH

regulaof the 

1994-3 Timeliness in Decommissioning Material Facilities 

Parts 30, 40, 70 59 FR 36026 

08/15/1997 Final No Comments 

01/28/2000 

AdoptemergeML092

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 

01/28/2000 

AdoptemergeML092

1995-2 Frequency of Medical Examinations for Use of 

Respiratory Protection Equipment Part 20 60 FR 7900 

03/13/1998 Final No Comments 

01/28/2000 

AdoptemergeML092

1995-3 Low-Level Waste Shipment Manifest Information and 

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

03/01/1998 Not Applicable Not Applicable NYSH

regulaof the 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

1995-4 Performance Requirements for Radiography Equipment 

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

06/30/1998 Final No Comments 

01/28/2000 

NYSHRegula1997-5 AdoptemergeML092

1995-5 Radiation Protection Requirements: Amended Definitions 

and Criteria Parts 19, 20 60 FR 36038 

08/14/1998 Final No Comments 

01/28/2000 

AdoptemergeML092

1995-6 Clarification of Decommissioning Funding Requirements 

Parts 30, 40, 70 60 FR 38235 

11/24/1998 Final No Comments 

01/28/2000 

AdoptemergeML092

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 

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 

01/28/2000 

NYSHRegula2004-1AdoptemergeML092

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 Proposed 

ML102020009 

No Comments 09/15/2010 ML102370215 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

1997-1 Resolution of Dual Regulation of Airborne Effluents of 

Radioactive Materials; Clean Air Act Part 20 61 FR 65120 

01/9/2000 Not Applicable Not Applicable NYSH

regulaof the 

1997-2 Recognition of Agreement State Licenses in Areas Under 

Exclusive Federal Jurisdiction Within an Agreement StatePart 150 62 FR 1662 

02/27/2000 Final 

ML092260295 License Condition ML092260295 

No Comments 09/08/2009 ML092310687 No Comments 09/08/2009 ML092310687 

1997-3 Criteria for the Release of Individuals Administered 

Radioactive Material Parts 20, 35 62 FR 4120 

05/29/2000 Final 

ML100120050 

Comments 03/08/2010 ML100330046 

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 Proposed 

Ml100600746 License Condition ML100600746 

Comments 05/06/2010 ML100890066 Comments 05/06/2010 ML100890066 

NYSHunderwthese 

*1997-6 Radiological Criteria for License Termination 

Parts 20, 30, 40, 70 62 FR 39057 

08/20/2000 Proposed 

ML102020009 

Comments 09/15/2010 ML102370215 

1997-7 Exempt Distribution of a Radioactive Drug Containing 

One Micro curie of Carbon-14 Urea Part 30 62 FR 63634 

01/02/2001 License Condition 

ML080170561 

No Comments 03/20/2008 ML080800306 

1998-1 Deliberate Misconduct by Unlicensed Persons 

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

02/12/2001 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

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

1998-4 Licenses for Industrial Radiography and Radiation Safety 

Requirements for Industrial Radiographic Operations Part 34 63 FR 37059 

07/09/2001 Proposed 

Ml100600746 License Condition ML100600746 

Comments 05/06/2010 ML100890066 Comments 05/06/2010 ML100890066 

NYSHunderwthese 

1998-5 Minor Corrections, Clarifying Changes, and a Minor Policy 

Change Parts 20, 35, 36 63 FR 39477; 63 FR 45393 

10/26/2001 Proposed 

ML101310506 

Comments 07/07/2010 ML101580277 

1998-6 Transfer for Disposal and Manifests: Minor Technical 

Conforming Amendment Part 20 63 FR 50127 

11/20/2001 Not Applicable Not Applicable NYSH

regulaof the 

1999-1 Radiological Criteria for License Termination of Uranium 

Recovery Facilities Part 40 64 FR 17506 

06/11/2002 Not Applicable Not Applicable NYSH

regulaof the 

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 License Condition 

ML092260298 

No Comments 09/03/2009 ML092320011 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

2000-1 Energy Compensation Sources for Well Logging and 

Other Regulatory Clarifications Part 39 65 FR 20337 

05/17/2003 License Condition 

ML100120053 

No Comments 02/23/2010 ML100350697 

2000-2 New Dosimetry Technology 

Parts 34, 36, 39 65 FR 63750 

01/08/2004 Final 

ML100050662 

No Comments 03/08/2010 ML100321001 

2001-1 Requirements for Certain Generally Licensed Industrial 

Devices Containing Byproduct Material Parts 30, 31, 32 65 FR 79162 

02/16/2004 License Condition 

for 32.52 (a) & (b) only ML040770455 

No Comments 04/02/2004 ML040930388 

AdoptemergeML092

2002-1 Revision of the Skin Dose Limit 

Part 20 67 FR 16298 

04/05/2005 Proposed 

ML101310506 

No Comments 07/07/2010 ML101580277 

2002-2 Medical Use of Byproduct Material 

Parts 20, 32, 35 67 FR 20249 

10/24/2005 Proposed 

ML100600745 License Condition ML080170561 

Comments 05/18/2010 ML100890015 No Comments 03/20/2008 ML080800306 

Part 3stereo

*2003-1 Financial Assurance for Materials Licensees 

Parts 30, 40, 70 68 FR 57327 

12/03/2006 Proposed 

ML102020009 

Comments 09/15/2010 ML102370215 

2004-1 Compatibility With IAEA Transportation Safety Standards 

and Other Transportation Safety Amendments Part 71 69 FR 3697 

10/01/2007 Final 

ML092590171 

Comments 10/23/2009 ML092710056 

2005-1 Security Requirements for Portable Gauges Containing 

Byproduct Material Part 30 70 FR 2001 

07/11/2008 License Condition 

ML092590174 

No Comments 10/07/2009 ML092710325 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

2005-2 Medical Use of Byproduct Material - Recognition of 

Specialty Boards Part 35 70 FR 16336; 71 FR 1926 

04/29/2008 Proposed 

ML100600745 

Comments 05/18/2010 ML100890015 

2005-3 Increased Controls for Risk-Significant Radioactive 

Sources (NRC Order EA-05-090)

70 FR 72128 

12/01/2005 License Condition 

ML053120138 

No Comments 11/10/2005 ML053180041 

2006-1 Minor Amendments 

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

03/27/2009 Proposed 

ML100600745 

Comments 05/18/2010 ML100890015 

2006-2 National Source Tracking System - Serialization 

Requirements Part 32 with reference to Part 20 Appendix E 71 FR 65685 

02/06/2007 Not Applicable1 Not Applicable NYSH

FSMEhad no ML070

2006-3 National Source Tracking System 

Part 20 71 FR 65685, 72 FR 59162 

01/31/2009 License Condition 

ML083240082 

No Comments 12/11/2008 ML083390393 

2007-1 Medical Use of Byproduct Material - Minor Corrections 

and Clarifications Parts 32 and 35 72 FR 45147, 54207 

10/29/2010 Proposed 

ML100600745 

Comments 05/18/2010 ML100890015 

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 

2007-3 Requirements for Expanded Definition of Byproduct 

Material Parts 20, 30, 31, 32, 33, 35, 61, 150 72 FR 55864 

11/30/2010 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

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 Final 

ML091730154 

Comments 08/04/2009 ML091820407 

2008-1 Occupational Dose Records, Labeling Containers, and 

Total Effective Dose Equivalent Parts 19, 20 72 FR 68043 

02/15/2011 

2009-1 Medical Use of Byproduct Material – Authorized User 

Clarification Part 35 74 FR 33901 

09/28/2012 Proposed 

ML100600745 

Comments 05/18/2010 ML100890015 

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