March 20, 2008 

Steven Gavitt, CHP, Director 

Bureau of Environmental Radiation Protection 

New York State Health Department 

547 River Street 

Troy, NY 12180-2216 

Dear Mr. Gavitt: 

We have reviewed the New York legally binding requirements, license conditions for Updates 

Respiratory Protection and Controls to Restrict Internal Exposure-Restricted Areas, Gamma 

Stereotactic Radiosurgery Units, and High Dose Rate Remote Afterloader Units; variance from 

specific regulations for Carbon-14 Urea Capsules; and regulations for Transportation of 

Radioactive Materials received by our office on January 17, 2008. These requirements were 

reviewed by comparison to the equivalent Nuclear Regulatory Commission (NRC) rules in 10 

CFR Parts 20, 30, 35, 71 and the requirements of the four amendments identified in the 

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

regulations with you on March 19, 2008. 

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

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 Federal and State 

Materials and Environmental Management Programs (FSME) Procedure SA-200. 

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 

FSME Procedure SA-201, AReview 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 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://www.hsrd.ornl.gov/nrc/rulemaking.htm. 
Steven Gavitt, CHP, Director -2- March 20, 2008 

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 (email: kxs@nrc.gov) or 

Monica Orendi at (301) 415-3938 (email: mlo1@nrc.gov). 

Sincerely, 

\ RA by ADWhite \ 

Robert J. Lewis, Director 

Division of Materials Safety and State Agreements 

Office of Federal and State Materials and 

Environmental Management Programs 

Enclosures: 

As stated 
Steven Gavitt, CHP, Director -2- March 20, 2008 

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 (email: kxs@nrc.gov) or 

Monica Orendi at (301) 415-3938 (email: mlo1@nrc.gov). 

Sincerely, 

\ RA ADWhite \ 

Robert J. Lewis, Director 

Division of Materials Safety and State Agreements 

Office of Federal and State Materials and 

Environmental Management Programs 

Enclosures: 

As stated 

Distribution: 

DIR RF (8-7) SUNSI Review Complete 

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

JKottan, RSAO : Non-Sensitive G Sensitive 

MOrendi [NY] File 

DOCUMENT NAME: G:\DMSSA\SAISB\REGULATION TOOLBOX\STATES\NEW YORK\8-7\8-7.DOC 

ML of Incoming Document: ML080170561 

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 SAISB SAISB OGC SAIS:BC MSSA:DD 

NAME MOrendi KSchneider BJones DWhite RLewis 

DATE 01/31/08* 01/31/08* 03/19/08* 03/20/08* 03/20/08* 

ML080800306 OFFICIAL RECORD COPY PKG. ML080800312
COMPATIBILITY COMMENTS ON NEW YORK STATE HEALTH DEPARTMENT LEGALLY 

BINDING REQUIREMENTS 

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

1 License 

Condition 

20.1003 1999-3 B Definition: Fit Test 

New York omits Aor quantitatively@

from its definition. 

New York needs to add the words Aor 

quantitatively” to its definition for Fit 

test in order to meet the Compatibility 

Category B designation assigned to 

10 CFR 20.1003 definition Fit test. 

2 N/A 20.1003 1999-3 B Definition: Hood

New York omits the definition for 

AHood@ from its license condition. 

New York needs to add the definition 

for AHood@ to its license condition in 

order to meet the Compatibility 

Category B designation assigned to 

10 CFR 20.1003 definition Hood. 

3 License 

Condition 

20.1003 1999-3 B Definition: Qualitative Fit Test 

New York uses the words Apass/mail@

instead of Apass fail@ in its definition of 

Qualitative fit test. 

New York needs to change its license 

condition definition of Qualitative fit 

test to read Ameans a pass/fail fit 

test...@ in order to meet the 

Compatibility Category B designation 

assigned to 10 CFR 20.1003 

definition Qualitative fit test. 

4 License 

Condition 

20.1705 1999-3 B Application for use of higher 

assigned protection factors 

New York references A...in excess of 

those specified in Appendix A to Part 

16.@ Since this is a license condition 

and New York is placing Appendix A 

in Table 1 attached to the license 

condition, New York should state A in 

excess of those specified in attached 

Table 1: Appendix A to Part 20.@
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

New York needs to make the above 

reference change in order to meet the 

Compatibility Category B designation 

assigned to 10 CFR 20.1705. 

5 16.17 10 CFR 71 2004-1 NRC Transportation 

New York cites all of 10 CFR 71 by 

reference in Section 16.17. However 

in its regulations NY fails to omit those 

sections specifically designated 

Compatibility Category NRC (under 

NRC jurisdiction). NY has taken 

interim action by issuing a 

Policy/Procedure to its staff regarding 

which sections are the exclusive use 

of the NRC and are therefore not to 

be enforced. NY needs to add 

language to 16.17 specifically 

excluding 10 CFR 71.2, 71.6, 71.13(c) 

and (d), 71.14(b), 71.19, 71.101(c)(2) 

(d) and (e), 71.107, 71.109, 71.111, 

71.113, 71.115, 71.117, 71.119, 

71.121, 71.123, and 71.125. 

New York needs to add language to 

16.17 specifically excluding the above 

sections in order to meet the 

Compatibility Category NRC 

designations assigned in 10 CFR 71. 
STATE REGULATION STATUS

State: New York State Health Department Tra[4 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 NYSH

Regula1997-5

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 

1991-4 Notification of Incidents 

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

10/15/1994 

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 

1993-2 Licensing and Radiation Safety Requirements for 

Irradiators Part 36 58 FR 7715 

07/01/1996 
RATS ID NRC Chronology Identification Date Due for 

State Adoption

Incoming Package 

Outgoing Package 

Notes 

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

Part 61 58 FR 33886 

07/22/1996 

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 

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 

1995-2 Frequency of Medical Examinations for Use of 

Respiratory Protection Equipment Part 20 60 FR 7900 

03/13/1998 

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 

1995-4 Performance Requirements for Radiography Equipment 

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

06/30/1998 NYSH

Regula1997-5

1995-5 Radiation Protection Requirements: Amended Definitions 

and Criteria Parts 19, 20 60 FR 36038 

08/14/1998 

1995-6 Clarification of Decommissioning Funding Requirements 

Parts 30, 40, 70 60 FR 38235 

11/24/1998 
RATS ID NRC Chronology Identification Date Due for 

State Adoption

Incoming Package 

Outgoing Package 

Notes 

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 Not Required Not Required New Y

Regula2004-1

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 

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 

1997-3 Criteria for the Release of Individuals Administered 

Radioactive Material Parts 20, 35 62 FR 4120 

05/29/2000 

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 

1997-6 Radiological Criteria for License Termination 08/20/2000 
RATS ID NRC Chronology Identification Date Due for 

State Adoption

Incoming Package 

Outgoing Package 

Notes 

Parts 20, 30, 40, 70 62 FR 39057 

i1997-7 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 

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 

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

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

10/26/2001 

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 

10/04/2002 Not Required Not Required These 

require
RATS ID NRC Chronology Identification Date Due for 

State Adoption

Incoming Package 

Outgoing Package 

Notes 

Requested Information Part 31 64 FR 42269 

Compa

i1999-3 Respiratory Protection and Controls to Restrict Internal 

Exposure Part 20 64 FR 54543; 64 FR 55524 

02/02/2003 License Condition 

ML080170561 

Comments 03/20/2008 ML080800306 

2000-1 Energy Compensation Sources for Well Logging and 

Other Regulatory Clarifications Part 39 65 FR 20337 

05/17/2003 

2000-2 New Dosimetry Technology 

Parts 34, 36, 39 65 FR 63750 

01/08/2004 

2001-1 Requirements for Certain Generally Licensed Industrial 

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

02/16/2004 

2002-1 Revision of the Skin Dose Limit 

Part 20 67 FR 16298 

04/05/2005 

i2002-2 Medical Use of Byproduct Material 

Parts 20, 32, 35 67 FR 20249 

10/24/2005 License Conditions 

ML080170561 

No Comments 03/20/2008 ML080800306 

Part 35 stereo

2003-1 Financial Assurance for Materials Licensees 

Parts 30, 40, 70 68 FR 57327 

12/03/2006 

i2004-1 Compatibility With IAEA Transportation Safety Standards 

and Other Transportation Safety Amendments Part 71 69 FR 3697 

10/01/2007 Final 

ML08017561 

Comments 03/20/2008 ML080800306 

2005-1 Security Requirements for Portable Gauges Containing 

Byproduct Material Part 30 70 FR 2001 

07/11/2008 
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 

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 

2006-2 National Source Tracking System - Serialization 

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

02/06/2007 Not Applicablei Not Applicable NYSH

FSMEhad no ML070

2006-3 National Source Tracking System 

Part 20 71 FR 65865, 72 FR 59162 

01/31/2009 

2007-1 Medical Use of Byproduct Material - Minor Corrections 

and Clarifications Parts 32 and 35 72 FR 45147, 54207 

10/29/2010 

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 

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 
RATS ID NRC Chronology Identification Date Due for 

State Adoption

Incoming Package 

Outgoing Package 

Notes 

2008-1 Occupational Dose Records, Labeling Containers, and 

Total Effective Dose Equivalent Parts 19, 20 72 FR 68043 

02/15/2011 

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