Gavitt 

UNITED STATES

NUCLEAR REGULATORY COMMISSION 

WASHINGTON, D.C. 20555-0001 

February 8, 2016 

Mr. Stephen M. Gavitt, Director 

Bureau of Environmental Radiation Protection 

New York State Department of Health 

Empire State Plaza 

Corning Tower, 12th Floor 

Albany, NY 12237 

Dear Mr. Gavitt: 

We have reviewed the New York Department of Health legally binding requirements for the 

Physical Protection of Byproduct Material, received by our office on December 17, 2015. These 

requirements were reviewed by comparison to the equivalent U.S. Nuclear Regulatory 

Commission (NRC) rules and the requirements of the three amendments identified in the 

enclosed State Regulation Status (SRS) Data Sheet. We discussed our review of the legally 

binding requirements with Robert Dansereau on February 5, 2016. 

As a result of our review, we have two comments that have been identified in the enclosure. 

While we note that Comment No. 2 is not related to Part 37 requirements (i.e. 30.13), it is part of 

RATS ID 2013-1, and therefore has been included for completeness. Please note that we have 

limited our review to the legally binding requirements required for compatibility and/or health and 

safety. We have determined that if these requirements are revised, incorporating our comments 

and without other significant change, they would meet the compatibility and health and safety 

categories established in the Office of Nuclear Material Safety and Safeguards (NMSS) 

Procedure SA-200, “Compatibility Categories and Health and Safety Identification for NRC 

Regulations and Other Program Elements.” 

We request that when you revise your legally binding requirements to address our comments, a 

copy of the revised legally binding requirements be provided to us for review. As requested in 

NMSS Procedure SA-201, “Review of State Regulatory Requirements,” please highlight the 

location of any changes made by New York, in response to our comments, and provide a copy 

to Division of Material Safety, State, Tribal, and Rulemaking Programs, NMSS. 

The SRS Data Sheet summarizes our knowledge of the status of other New York Department of 

Health 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 NMSS State Communication Portal: 

https://scp.nrc.gov/rulemaking.html. 
S. Gavitt 2 

Additionally, please note that NRC has previously issued certain security Orders to one New 

York DOH licensee. We have not listed the name of the licensee in this letter because that 

information is Official Use Only and cannot be made publicly available. Because the 

NRC-issued Orders are still legally binding, they must be rescinded by NRC concurrent with 

New York’s promulgation of final regulations. Accordingly, close coordination is needed 

between NRC and your office to ensure there are no conflicts, duplications, or gaps regarding 

the security-related requirements for these licensees. Please contact Adelaide Giantelli, Branch 

Chief, Source Management and Protection Branch, NMSS (Adelaide.giantelli@nrc.gov) for 

information regarding the affected New York licensees and for coordination with rescission of 

the NRC-issued Orders and New York imposition of the legally binding requirement on this 

licensee. 

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 Michelle 

Beardsley, State Regulation Review Coordinator, at (610) 337-6942 

(Michelle.Beardsley@nrc.gov) or Donna Janda at (610) 337-5371 (Donna.Janda@nrc.gov). 

Sincerely, 

/RA Paul Michalak for/ 

Pamela J. Henderson, Deputy Director 

Division of Material Safety, State, Tribal 

 and Rulemaking Programs 

Office of Nuclear Material Safety 

 and Safeguards 

Enclosures: 

1. Compatibility Comments 

2. New York Department of 

Health SRS Data Sheet
S. Gavitt 2 

Additionally, please note that NRC has previously issued certain security Orders to one New 

York DOH licensee. We have not listed the name of the licensee in this letter because that 

information is Official Use Only and cannot be made publicly available. Because the 

NRC-issued Orders are still legally binding, they must be rescinded by NRC concurrent with 

New York’s promulgation of final regulations. Accordingly, close coordination is needed 

between NRC and your office to ensure there are no conflicts, duplications, or gaps regarding 

the security-related requirements for these licensees. Please contact Adelaide Giantelli, Branch 

Chief, Source Management and Protection Branch, NMSS (Adelaide.giantelli@nrc.gov) for 

information regarding the affected New York licensees and for coordination with rescission of 

the NRC-issued Orders and New York imposition of the legally binding requirement on this 

licensee. 

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 Michelle 

Beardsley, State Regulation Review Coordinator, at (610) 337-6942 

(Michelle.Beardsley@nrc.gov) or Donna Janda at (610) 337-5371 (Donna.Janda@nrc.gov). 

Sincerely, 

/RA Paul Michalak for/ 

Pamela J. Henderson, Deputy Director 

Division of Material Safety, State, Tribal 

 and Rulemaking Programs 

Office of Nuclear Material Safety 

 and Safeguards 

Enclosures: 

1. Compatibility Comments 

2. New York Department of 

Health SRS Data Sh

DISTRIBUTION: SP 05 

DIR RF (16-29) 

Donna Janda, RSAO 

New York File 

OFFICE RI ASPB OGC ASPB:BC MSTR:DD 

NAME DJanda/mb 

for 

MBeardsley CEngland via 

email 

PMichalak P. Michalak for 

PHenderson 

DATE 12/30/15 12/30/15 2/5/16 2/8/16 2/8/16 

ML15365A511 OFFICIAL RECORD COPY Package ML15355A039 
Enclosure 1 

COMPATIBILITY COMMENT ON NEW YORK DEPARTMENT OF HEALTH 

LEGALLY BINDING REQUIREMENTS 

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

1 LC 2.(d) Part 37 N/A N/A General comment: Implementation 

date 

New York has set an implementation 

date of 9 months from the effective 

date of the amendment for licensees 

to meet the requirements in 10 CFR 

Part 37 and an implementation date 

of 90 days from the effective date of 

the amendment for reviewing officials 

to meet the requirements in 10 CFR 

37.21(c). 

New York needs to set an 

implementation date of no later than 

March 19, 2016, in order to meet the 

effective date for the implementation 

of RATS ID 2013-1 as described in 

the NMSS letter STC-15-072, 

Effective Date for Implementation of 

Part 37 Requirements, dated 

September 11, 2015. 

2 10 NYCRR 

16.1(b)(2) 

30.13 2013-1 B Carriers 

New York omits “freight forwarders 

and warehousemen from10 NYCRR 

16.1(b)(2). 

New York needs to add freight 

forwarders and warehouseman to 10 

NYCRR 16.1(b)(2) in order to meet 

the Compatibility Category B 

designation assigned to 10 CFR 

30.13.
STATE REGULATION STATUS

State: New York State Department of Health Tracking Ticket 

Date: 02/08/201

[ 3 amendment(s) reviewed identified by a *at the beginning of the equivalent NRC requirement.] 

RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Letter Outgoing 

Package 

Note

1991-1 Safety Requirements for Radiographic Equipment 

Part 34 55 FR 843 (Superceded by 1997-5) 

01/10/1994 Final No Comments NYSH

Regu1997Adopsince ML09

1991-2 ASNT Certification of Radiographers 

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

none Not Required Not Required Thes

requiof Co

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 

Adopsince ML09

1991-4 Notification of Incidents 

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

10/15/1994 Final No Comments 

01/28/2000 

Adopsince ML09

1992-1 Quality Management Program and 

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

01/27/1995 

1992-2 Eliminating the Recordkeeping Requirements 

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

none Not Required Not Required Thes

requiof Co
2 

RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Letter Outgoing 

Package 

Note

1993-1 Decommissioning Recordkeeping and License 

Termination: Documentation Additions [Restricted areas and spill sites] Parts 30 and 40 58 FR 39628 

10/25/1996 Final No Comments 

01/28/2000 

Adopsince ML09

1993-2 Licensing and Radiation Safety Requirements for 

Irradiators Part 36 58 FR 7715 

07/01/1996 Final No Comments 

01/28/2000 

Adopsince ML09

1993-3 Definition of Land Disposal and Waste Site QA 

Program Part 61 58 FR 33886 

07/22/1996 Not Applicable Not Applicable NYSH

regulportio

1994-1 Self-Guarantee as an Additional Financial 

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

none Not Required Not Required Thes

requiof Co

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

regulportio

1994-3 Timeliness in Decommissioning Material Facilities 

Parts 30, 40 and 70 59 FR 36026 

08/15/1997 Final No Comments 

01/28/2000 

Adopsince ML09

1995-1 Preparation, Transfer for Commercial Distribution, 

and Use of Byproduct Material for Medical Use Parts 30, 32 and 35 59 FR 61767; 59 FR 65243; 60 FR 322 

01/01/1998 Final No Comments 

01/28/2000 

Adopsince ML09
3 

RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Letter Outgoing 

Package 

Note

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 

Adopsince ML09

1995-3 Low-Level Waste Shipment Manifest Information 

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

03/01/1998 Not Applicable Not Applicable NYSH

regulportio

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 

NYSHRegu1997Adopsince ML09

1995-5 Radiation Protection Requirements: Amended 

Definitions and Criteria Parts 19 and 20 60 FR 36038 

08/14/1998 Final No Comments 

01/28/2000 

Adopsince ML09

1995-6 Clarification of Decommissioning Funding 

Requirements Parts 30, 40 and 70 60 FR 38235 

11/24/1998 Final No Comments 

01/28/2000 

Adopsince ML09

1995-7 Medical Administration of Radiation and Radioactive 

Materials Parts 20 and 35 60 FR 48623 (Superceded by 2002-2 and 2005-2) 

10/20/1998 Only 

adop
4 

RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Letter Outgoing 

Package 

Note

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 

NYSHRegu2004Adopsince ML09

1996-2 One Time Extension of Certain Byproduct, Source 

and Special Nuclear Materials Licenses Parts 30, 40 and 70 61 FR 1109 

02/15/1999 Not Required Not Required Thes

requiof Co

1996-3 Termination or Transfer of Licensed Activities: 

Record keeping Requirements Parts 20, 30, 40, 61 and 70 61 FR 24669 

06/17/1999 License Condition 

ML14007A059 

No Comments 02/20/2014 ML14007A056 

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

regulportio

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 

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 and 35 62 FR 4120 

05/29/2000 Final 

ML100120050 

Comments 03/08/2010 ML100330046 
5 

RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Letter Outgoing 

Package 

Note

1997-4 Fissile Material Shipments and Exemptions 

Part 71 62 FR 5907 (Superceded by 2004-1) 

02/10/2000 Not Required Not Required Thes

requiof Co

1997-5 Licenses for Industrial Radiography and Radiation 

Safety Requirements for Industrial Radiography Operations Parts 30, 34, 71 and 150 62 FR 28947 

06/27/2000 Proposed 

Ml100600746 License Condition ML100600746 

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

NYSHlaybaradio

1997-6 Radiological Criteria for License Termination 

Parts 20, 30, 40 and 70 62 FR 39057 

08/20/2000 License Condition 

ML14007A059 

No Comments 02/20/2014 ML14007A056 

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 and 150 63 FR 1890; 63 FR 13773 

02/12/2001 Legally Binding 

Requirements ML13121A233 

Comments 06/19/2013 ML13150A207 

1998-2 Self-Guarantee of Decommissioning Funding by 

Nonprofit and Non-Bond-Issuing Licensees Parts 30, 40 and 70 63 FR 29535 

07/01/2001 Not Required Not Required Thes

requiof Co

1998-3 License Term for Medical Use Licenses 

Part 35 63 FR 31604 (Superceded by 2002-2) 

07/10/2001 Not Required Not Required Thes

requiof Co
6 

RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Letter Outgoing 

Package 

Note

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 

NYSHlaybaradio

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

Policy Change Parts 20, 32, 35, 36 and 39 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

regulportio

1999-1 Radiological Criteria for License Termination of 

Uranium Recovery Facilities Part 40 64 FR 17506 

06/11/2002 Not Applicable Not Applicable NYSH

regulportio

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 Thes

requiof Co

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 

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 
7 

RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Letter Outgoing 

Package 

Note

2000-2 New Dosimetry Technology 

Parts 34, 36 and 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 and 32 65 FR 79162 

02/16/2004 License Condition 

for 32.52 (a) & (b) only ML040770455 

No Comments 04/02/2004 ML040930388 

Adopsince ML09

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 and 35 67 FR 20249 

10/24/2005 Proposed 

ML100600745 License Condition ML080170561 Final ML13150A109 

Comments 05/18/2010 ML100890015 No Comments 03/20/2008 ML080800306 Comments 08/08/2013 ML13197A356 

Part 3stereonly Part 3

2003-1 Financial Assurance for Materials Licensees 

Parts 30, 40 and 70 68 FR 57327 

12/03/2006 License Condition 

ML14007A059 

No Comments 02/20/2014 ML14007A056 

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 
8 

RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Letter Outgoing 

Package 

Note

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 

2005-2 Medical Use of Byproduct Material - Recognition of 

Specialty Boards Part 35 70 FR 16336; 71 FR 1926 

04/29/2008 Final 

ML13150A107 

No Comments 08/08/2013 ML13197A356 

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 Final ML13150A107 

Comments 05/18/2010 ML100890015 Comments 08/08/2013 ML13197A356 

Part 3

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

to FScurreapplicML07

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 
9 

RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Letter Outgoing 

Package 

Note

2007-1 Medical Use of Byproduct Material - Minor 

Corrections and Clarifications Parts 32 and 35 72 FR 45147, 54207 

10/29/2010 Proposed 

ML100600745 Final ML13150A107 

Comments 05/18/2010 ML100890015 No Comments 08/08/2013 ML13197A356 

Part 3

2007-2 Exemptions From Licensing, General Licenses, and 

Distribution of Byproduct Material: Licensing and Reporting Requirements Parts 30, 31, 32 and 150 72 FR 58473 

12/17/2010 

2007-3 Requirements for Expanded Definition of Byproduct 

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

11/30/2010 Final 

ML13150A107 

No Comments 08/08/2013 ML13197A356 

Part 3

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 and 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 Final 

ML13150A107 

No Comments 08/08/2013 ML13197A356 

2011-1 Decommissioning Planning 

Parts 20, 30, 40 and 70 76 FR 35512 

12/17/2015 
10 

RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Letter Outgoing 

Package 

Note

2011-2 Licenses, Certifications, and Approvals for Materials 

Licensees Parts 30, 36, 39, 40, 70, and 150 76 FR 56951 

11/14/2014 

2012-1 Change of Compatibility of 10 CFR 31.5 and 31.6 

(See RATS ID: 2001-1 for Rule text) 77 FR 3640 

01/25/2015 

2012-2 Advance Notification to Native American Tribes of 

Transportation of Certain Types of Nuclear Waste Part 71 77 FR 34194 

08/10/2015 

2012-3 Technical Corrections 

Part 30, 34, 40 and 71 77 FR 39899 

08/06/2015 

2012-4 Requirements for Distribution of Byproduct Material 

Parts 30, 31, 32, 40 and 70 77 FR 43666 

10/23/2015 

*2013-1 Physical Protection of Byproduct Material, 10 CFR 

Parts 20, 30, 32, 33, 34, 35, 36, 37, 39, and 71 78 FR 16922 

03/19/2016 Proposed 

ML15355A046 

Comment 02/08/16 ML15355A039 

2013-2 Distribution of Source Material to Exempt Persons 

and to General Licensees and Revision of General License and Exemptions, Parts 30, 40 and 70 78 FR 32310 

08/27/2016 

2015-1 Domestic Licensing of Special Nuclear Material – 

Written Reports and Clarifying Amendments Part 70 79 FR 57721, 80 FR 143 

01/26/2018 
11 

RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Letter Outgoing 

Package 

Note

*2015-2 Safeguards Information - Modified Handling 

Categorization, Change for Materials Facilities Parts 30, 37, 73 and 150 79 FR 58664, 80 FR 3865 

01/28/2018 Proposed 

ML15355A046 

No Comments 02/08/16 ML15355A039 

2015-3 Revisions to Transportation Safety Requirements 

and Harmonization with International Atomic Energy Agency Transportation Requirements Part 71 80 FR 33987 

07/13/2018 

*2015-4 Miscellaneous Corrections, Parts 37 and 40 

80 FR 45841 

09/02/2018 Proposed 

ML15355A046 

No Comments 02/08/16 ML15355A039 

2015-5 Miscellaneous Corrections, 

Parts 19, 20, 30, 32, 37, 40, 61, 70, 71, and 150 80 FR 74974 

12/31/2018 

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