May 18, 2010 

Stephen M. Gavitt, CHP, Director 

Bureau of Environmental Radiation Protection 

New York State Department of Health 

547 River Street 

Troy, NY 12180-2216 

Dear Mr. Gavitt: 

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

10 NYCRR 16, received by our office on March 1, 2010. These regulations were reviewed by 

comparison to the equivalent Nuclear Regulatory Commission (NRC) rules in 10 CFR Parts 20, 30, 

32, 35, 40, 70, and the requirements of the five amendments identified in the enclosed State 

Regulation Status (SRS) Data Sheet. We discussed our review of the regulations with Robert 

Dansereau on May 17, 2010. 

As a result of our review, we have 37 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 SA200. 

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 State 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 Michelle 

Beardsley at 610-337-6942 (michelle.beardsley@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 (10-12) SUNSI Review Complete 

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

DJanda, RI : Non-Sensitive G Sensitive 

JKotton, RI 

NY File 

ML of Incoming Document: ML100600745 

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 MBeardsley / KNS KSchneider BJones DWhite TReis

DATE 04/12 /10 04/13/10 05/6 /10 05/18 /10 05/18/10 

ML100890018 OFFICIAL RECORD COPY Package ML100890015
 COMPATIBILITY COMMENTS ON NEW YORK STATE PROPOSED REGULATIONS 

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

1 16.2 (78) 20.1003 2002-2 A Definitions: Occupational Dose 

New York (NY) proposed definition of 

“occupational dose” omits the phrase: 

”from exposure to individuals 

administered radioactive materials 

and released according to Section 10 

CFR 35.75” 

NY needs to add the above phrase to 

10 NYCRR 16.2 (78) in order to meet 

the Compatibility Category A 

designation assigned to Section 10 

CFR 20.1003 definition Occupational 

Dose.

2 16.2 (89) 20.1003 2002-2 A Definitions: Public Dose 

NY’s proposed definition of “public 

dose” omit the following phrase: 

”from exposure to individuals 

administered radioactive material and 

released under Section 10 CFR 

35.75”. 

NY needs to add the above phrase to 

10 NYCRR16.2 (89) in order to meet 

the Category A designation assigned 

to Section 10 CFR 20.1003 definition 

Public Dose. 

3 16.7 20.1301 (a) and 

(c) 

2002-2 A Dose limits for individual members 

of the public 

In NYCCRR 16.7(a)(1)(ii), NY needs 

to delete the phrase “ and which 

results in a total effective dose 

equivalent to a member of the public 

which does not exceed 5 mSv (.5 

rem) in a year”, which as written 

applies to all license activities and is 

not limited to members of the public 

under Part 35 as corresponds to 

Section 10 CFR 20.1301(c)(1). 

NY omits equivalent sections to 

Section 10 CFR 20.1301(c) from its 

regulations. 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

NY needs to make the above changes 

to their regulation in the 10 NYCRR 

16.7 in order to meet the Category A 

designation assigned to Section 10 

CFR 1301(a) and (c). 

4 38.35(j) 32.72 2002-2 

2006-1 

2007-1 

B Manufacture, preparation, or 

transfer for commercial distribution 

of radioactive drugs containing 

byproduct material for medical use 

under Part 35 

NY omits equivalent sections to 10 

CFR 32.72(a)(2)(i), (a)(2)(iv), (a)(2)(v), 

(b), and (d). 

NY needs to add equivalent sections 

to those listed above to 18 NYCRR 

38.35(j) in order to meet the 

Compatibility Category B designation 

assigned to Section 10 CFR 32.72. 

5 38.35 (i) 32.74 2002-2 

2006-1 

2007-1 

B Manufacture and distribution of 

sources or devices containing 

byproduct material for medical use 

NY’s proposed regulation omits the 

word “transmission” as stated in 

Section 10 CFR 32.74(a). 

NY also lists the wrong references in 

18 NYCRR 38.35(i)(1)(iii). This 

paragraph should read “... to use 

radioactive material identified in 

section 35.65, 35.400, 35.500 and 

35.600, as appropriate, of Part 35 of 

the Code of Federal Regulations ...” 

NY needs to make the above changes 

to their regulation in order to meet the 

Compatibility Category B designation 

assigned to Section 10 CFR 32.74. 

6 16.123 (a)(6) 35.2 2002-2 B Definition: Authorized Medical 

Physicist 

NY’s proposed definition of authorized 

medical physicist states “...identified 

as a Radiation Therapy Physicist or 

...”. NY either needs to define 

Radiation Therapy Physicist or 

change this to say “teletherapy 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

physicist”. 

NY omits the word “authorized” before 

medical physicist. 

NY omits equivalent sections to (2)(i)-

(iv) in NRC’s definition of authorized 

medical physicist. 

NY needs to make the above changes 

in order to meet the Compatibility 

Category B designation assigned to 

Section 10 CFR 35.2 definition 

Authorized Medical Physicist. 

7 16.123 (a)(6) 35.2 2002-2 B Definition: Authorized Nuclear 

Pharmacist 

NY’s definition of “authorized nuclear 

pharmacist” omits the equivalent 

requirements of paragraphs (2)(i), (ii), 

(iii), (iv) (3) and (4) of NRC’s 

definition. 

NY needs to add the above in order to 

meet the Compatibility Category B 

designation assigned to Section 10 

CFR 35.2 definition Authorized 

Nuclear Pharmacist. 

8 16.123 (a)(6) 35.2 2002-2 B Definition: Authorized User 

"NY needs to change the second half 

of their definition "... and is identified 

as an authorized user on ..." to be 

essential identical to paragraphs 

(2)(i), (ii), (iii) and (iv) of NRC's 

definition of Authorized User. This 

includes changing the word "and" in 

the above sentence to "or" and other 

revisions to be essential identical to 

paragraphs (2)(i), (ii), (iii) and (iv) of 

NRC's definition. 

NY needs to make the above change 

in order to meet the Compatibility 

Category B designation assigned to 

Section 10 CFR 35.2 definition 

Authorized User. 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

9 N/A 35.2 2002-2 C Definition: Medical Use 

NY omits the definition of “medical 

use” from their regulations. 

NY needs to add the definition of 

“medical use” to 16.2 or 16.123 in 

order to meet the Compatibility 

Category C designation assigned to 

Section 10 CFR 35.2 definition 

Medical Use. 

10 16.2 (99) 35.2 2002-2 

2005-2 

2006-1 

B Definition: Radiation Safety Officer 

NY’s definition of “Radiation Safety 

Officer” omits the requirements as 

stated in paragraphs (1) and (2) of 

NRC’s definition. 

NY needs to make the above change 

in order to meet the Compatibility 

Category B designation assigned to 

Section 10 CFR 35.2 definition 

Radiation Safety Officer. 

11 16.2 (114) 35.2 2002-2 [B] Definition: Sealed source 

NY needs to change its definition of 

Sealed source to be essentially 

identical to NRC’s definition of Sealed 

source. NRC defines Sealed source 

as any byproduct material that is 

encased in a capsule designed to 

prevent leakage or escape the 

byproduct material. 

NY needs to make the above change 

in order to meet the Compatibility 

Category B designation assigned to 

Section 10 CFR 35.2 definition Sealed 

source. 

12 N/A 35.6 2002-2 C Provision of Human Research 

Subjects 

NY omits this provision from their 

regulations. 

If NY does not allow research on 

human subjects then they would be 

more restrictive than NRC’s regulation 

and therefore would be compatible. 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

However NY references human 

research subjects in other sections of 

their regulations leading NRC to 

believe that NY does allow for 

research on human subjects. 

NY either needs to state in writing that 

they do not allow research on human 

subjects or the need to add an 

equivalent section to Section 10 CFR 

35.6 to their regulations in order to 

meet the Compatibility Category C 

designation assigned to Section 10 

CFR 35.6. 

13 16.5 (c) 35.24 (b) 2002-2 H&S Authority and responsibilities for 

the radiation protection program 

NY’s regulation does not require a 

written agreement between a 

licensee’s management and the 

Radiation Safety Officer (RSO). 

NY needs to add this requirement to 

16.5 in order to meet the Compatibility 

Category H&S designation assigned 

to Section 10 CFR 35.24.

14 16.5 (d) 35.24 (f) 2002-2 H&S Authority and responsibilities for 

the radiation protection program 

Section 10 CFR 35.24(f) states 

“Licensees that are authorized for two 

or more different types of use of 

byproduct material under Subpart 

E...” NY’s regulation in 16.5(d) states 

“... in hospitals and institutions of 

higher education ...“ By being very 

specific NY is potentially eliminating 

certain licensees that 35.24(f) would 

apply to and therefore not meeting the 

adequacy aspect of this regulation. 

NY needs to change 16.5(d) to 

include licensees that are authorized 

for two or more different types of use 

of byproduct material in order to meet 

the Compatibility Category H&S 

designation assigned to Section 10 

CFR 35.24 (f). 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

15 16.5 (f) 35.27 2002-2 H&S Supervision 

NY’s regulation 16.5(f) does not 

require the supervision to be by an 

authorized user. Also NY needs to 

expand 16.5(f) to include a 

requirement to “instruct the 

supervised individual in the licensee’s 

written radiation protection 

procedures, regulations of this 

chapter and license conditions with 

respect to the use of byproduct 

material” and to “Require the 

supervised individual to follow the 

instructions of the supervising 

authorized user for medical uses of 

byproduct material, written radiation 

protection procedures, regulations of 

this chapter, and license conditions 

with respect to medical use of 

byproduct material.” 

NY needs to add the above to 16.5(f) 

in order to meet the Compatibility 

Category H&S designation assigned 

to Section 10 CFR 35.27. 

16 N/A 35.49 2002-2 

2006-1 

C Suppliers for sealed sources or 

devices for medical use 

NY omits an equivalent section to 

Section 10 CFR 35.49 from its 

regulations. 

NY needs to add the essential 

objectives of Section 10 CFR 35.49 to 

10 NYCRR 16.123 in order to meet 

the Compatibility Category C 

designation assigned to Section 10 

CFR 35.49. 

17 16.123 (d)(1) 35.50 2002-2 

2005-2 

2006-1 

2009-1 

B Training for Radiation Safety 

Officer 

NY does not include recognition by 

the NRC or other Agreement States of 

a specialty board’s certification 

process. 

NY needs to remove “or” from the end 

of 16.123(d)(1)(i)(a) and replace it 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

with “To have its certification process 

recognized, a specialty board shall 

require all candidates for certification 

to:” 

NY needs to make the above changes 

to 16.123(d)(1) in order to meet the 

Compatibility Category B designation 

assigned to Section 10 CFR 35.50. 

18 16.123 (d)(2) 35.51 2002-2 

2005-2 

2006-1 

2009-1 

B Training for an authorized medical 

physicist 

NY needs to remove the introduction 

paragraph in 10 NYCRR 16.123(d)(2) 

or change it when they correct their 

definition of authorized medical 

physicist. 

NY does not include recognition by 

the NRC or other Agreement States of 

a specialty board’s certification 

process; 

NY needs to make the above changes 

to 16.123(d)(2) in order to meet the 

Compatibility Category B designation 

assigned to Section 10 CFR 35.51. 

19 16.123 (d)(3) 35.55 2002-2 

2005-2 

B Training for an authorized nuclear 

pharmacist 

NY’s regulation is not essentially 

identical to Section 10 CFR 35.55. 

NY needs to incorporate all of Section 

10 CFR 35.55 into 16.123 (d)(3) in 

order to meet the Compatibility 

Category B designation assigned to 

Section 10 CFR 35.55. 

20 38.35 (j)(3) 35.61 2002-2 H&S Calibration of survey instruments 

NY’s regulation omits the 

requirements in Section 10 CFR 

35.61 (a)(1), (a)(2), and (b). 

NY needs to add the essential 

objectives above to 18 NYCRR 

38.35(j)(3) in order to meet the 

Compatibility Category H&S 

designation assigned to Section 10 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

CFR 35.61. 

21 16.123(c)(4) 35.63 2002-2 H&S Determination of dosages of 

unsealed byproduct material for 

medical use 

NY’s lists a wrong reference in 

16.123(c)(4)(ii)(b)(1). It should say in 

12 NYCRR 38.35(j) instead of 12 

NYCRR 38.32(j). 

NY needs to make the above change 

in order to meet the Compatibility 

Category H&S designation assigned 

to Section 10 CFR 35.63. 

22 N/A 35.70 2002-2 H&S Surveys of ambient radiation 

exposure rate 

NY’s omits this requirement from their 

regulations. 

NY needs to add the essential 

objectives of Section 10 CFR 35.70 to 

10 NYCRR 16.123 in order to meet 

the Compatibility Category H&S 

designation assigned to Section 10 

CFR 35.70. 

23 16.123 

(b)(1)(i) 

35.100 2002-2 

2005-2 

2006-1 

H&S Use of unsealed byproduct material 

for uptake, dilution, and excretion 

studies for which a written 

directive is not required 

NY’s regulation omits the essential 

objectives of Section 10 CFR 

35.100(a), (b), (c), and (d) which state 

where material for uptake, dilution and 

excretion studies can be obtained 

from and who it can be prepared by. 

NY needs to embody the essential 

objectives of Section 10 CFR 35.100 

(a), (b), (c), and (d) in 16.123 (b)(1)(i) 

in order to meet the Compatibility 

Category H&S designation assigned 

to Section 10 CFR 35.100. 

24 16.123 

(b)(1)(i) 

35.190 2002-2 

2005-2 

2006-1 

B Training for uptake, dilution and 

excretion studies 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

2007-1 

2009-1 

NY does not include recognition by 

the NRC or other Agreement States of 

a specialty board’s certification 

process 

NY omits “or equivalent NRC or other 

Agreement State requirements” as 

stated in Section 10 CFR 35.190 (b), 

(c)(1)(ii) and (c)(2); 

NY omits a reference to their 

equivalent of Section 10 CFR 35.57 

(16.123(d)(5)) as stated in Section 10 

CFR 35.190(c)(1)(ii) and (c)(2). 

NY needs to make the above changes 

in order to meet the Compatibility 

Category B designation assigned to 

Section 10 CFR 35.190. 

25 16.123 

(b)(2)(i) 

35.200 2002-2 

2005-2 

2006-1 

H&S Use of unsealed byproduct material 

for imaging and localization 

studies for which a written 

directive is not required 

NY’s regulation omits the essential 

objectives of Section 10 CFR 

35.200(a), (b), (c), and (d) which state 

where material for imaging and 

localization studies can be obtained 

from and who it can be prepared by. 

NY needs to embody the essential 

objectives of Section 10 CFR 35.200 

(a), (b), (c), and (d) in 16.123 (b)(2)(i) 

in order to meet the Compatibility 

Category H&S designation assigned 

to Section 10 CFR 35.200. 

26 16.123 

(b)(2)(iii) 

35.204 2002-2 H&S Permissible molybdenum-99, 

strontium-82, and strontium-85 

concentration 

NY’s regulation states “milli”becquerel 

of molybdenum instead of 

“kilo”becquerel as stated in paragraph 

(a). 

NY needs to correct the prefix as 

stated above in 16.123(b)(2)(iii) in 

order to meet the Compatibility 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

Category H&S designation assigned 

to Section 10 CFR 35.204. 

27 16.123 

(b)(3)(i) 

35.300 2002-2 

2006-1 

H&S Use of unsealed byproduct material 

for which a written directive is 

required 

NY’s regulation omits the essential 

objectives of Section 10 CFR 

35.300(a), (b), (c), and (d) which state 

where material for which a written 

directive is required can be obtained 

from and who it can be prepared by. 

NY needs to embody the essential 

objectives of Section 10 CFR 35.300 

(a), (b), (c), and (d) in 16.123 (b)(3)(i) 

in order to meet the Compatibility 

Category H&S designation assigned 

to Section 10 CFR 35.300. 

28 16.123 

(b)(3)(ii) 

35.390 2002-2 

2005-2 

2006-1 

2009-1 

B Training for use of unsealed 

byproduct material for which a 

written directive is required 

In 16.123(b)(3)(ii)(b)((1)(ii) and 

16.123(b)(3)(ii)(b)(2), NY requires all 

authorized users who are supervising 

work experience and providing 

preceptor attestation to also have 

experience in administering dosages 

in the same dose category or 

categories as the individual 

requesting authorized user status. In 

Section 10 CFR 35.390(b)(1)(ii) and 

35.390(b)(2) NRC only requires this 

for authorized users who meet the 

requirements in Section 10 CFR 

35.390(b). NY needs to change 

16.123(b)(3)(ii)(b)((1)(ii) and 

16.123(b)(3)(ii)(b)(2), to match NRC’s 

Section 10 CFR 35.390(b)(1)(ii) and 

Section 10 CFR 35.390(b)(2). 

 

NY omits the phrase “or equivalent 

NRC or other Agreement State 

requirements” in 

16.123(b)(3)(ii)(b)(1)(ii) and 

16.123(b)(3)(ii)(b)(2). 

NY omits their equivalent requirement 

to Section 10 CFR 35.57 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

(16.123(d)(5)) as stated in Section 10 

CFR 35.390 (b)(1)(ii) and (b)(2). 

. 

NY needs to make the above changes 

in order to meet the Compatibility 

Category B designation assigned to 

Section 10 CFR 35.390. 

29 16.123 

(b)(3)(iii) 

35.392 2002-2 

2005-2 

2006-1 

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) 

NY omits the phrase “or equivalent 

NRC or other Agreement State 

requirements” in 16.123(b)(3)(iii)(b), 

(c)(2), and (c)(3) 

NY omits their equivalent requirement 

to Section 10 CFR 35.57 

(16.123(d)(5)) as stated in Section 10 

CFR 35.392 (c)(2) and (3). 

NY needs to make the above changes 

in order to meet the Compatibility 

Category B designation assigned to 

Section 10 CFR 35.392 

30 16.123 

(b)(3)(iii) 

**(should be 

(iv)) 

35.394 2002-2 

2005-2 

2006-1 

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) 

NY lists this section as 

16.123(b)(3)(iii), however NY already 

has a section 16.123(b)(3)(iii). This 

should be recodified as 

16.123(b)(3)(iv). 

NY states in 16.123(b)(3)(iii)(c)(2)(vi) 

“... that includes at least 3 cases 

involving the oral administration of 

greater than or equal to 33 millicuries 

...”. This is incorrect. NY should 

state “...oral administration of greater 

than 33 millicuries ...” 

NY omits the phrase “or equivalent 

NRC or other Agreement State 

requirements” in 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

16.123(b)(3)(iii)(c)(2)and (3). 

NY omits their equivalent requirement 

to Section 10 CFR 35.57 

(16.123(d)(5)) as stated in paragraphs 

(c)(2) and (3). 

NY needs to make the above changes 

in order to meet the Compatibility 

Category B designation assigned to 

Section 10 CFR 35.394. 

31 16.123 

(b)(3)(iv) 

35.396 2005-2 

2006-1 

2009-1 

B Training for the parenteral 

administration of unsealed 

byproduct 

material requiring a written 

directive 

NY omits the phrase “or equivalent 

NRC or other Agreement State 

requirements” in 16.123(b)(3)(iv)(a), 

(b), (d)(2), and (d)(3). 

NY omits their equivalent requirement 

to Section 10 CFR 35.57 

(16.123(d)(5)) in paragraphs 

16.123(b)(3)(iv)(d)(2) and (3). 

NY needs to make the above changes 

in order to meet the Compatibility 

Category B designation assigned to 

Section 10 CFR 35.396. 

32 16.123 

(b)(4)(ii) 

35.490 2002-2 

2005-2 

2006-1 

2009-1 

B Training for use of manual 

brachytherapy sources 

NY omits the phrase “or equivalent 

NRC or other Agreement State 

requirements” in 

16.123(b)(4)(ii)(c)(1)(ii), (c)(2), and 

(c)(3). 

NY omits their equivalent requirement 

to Section 10 CFR 35.57 

(16.123(d)(5)) in 

16.123(b)(4)(ii)(c)(1)(ii), (c)(2), and 

(c)(3). 

NY needs to make the above changes 

in order to meet the Compatibility 

Category B designation assigned to 

Section 10 CFR 35.490. 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

33 16.123 (b)(5) 35.500 2002-2 C Use of sealed sources for 

diagnosis 

NY needs to add “as approved in the 

Sealed Source and Device Registry” 

to the end of 16.123(b)(5))i)(a) and 

(b). 

NY needs to make the above change 

in order to meet the Compatibility 

Category C designation assigned to 

Section 10 CFR 35.500. 

34 16.123 

(b)(6)(ii) 

35.690 2002-2 

2005-2 

2006-1 

2009-1 

B Training for use of remote 

afterloader units, teletherapy units 

and gamma stereotactic 

radiosurgery units 

NY omits the phrase “or equivalent 

NRC requirements” in 

16.123(b)(6)(ii)(c)(1)(ii), (c)(2), and 

(c)(3). 

NY omits their equivalent requirement 

to Section 10 CFR 35.57 

(16.123(d)(5)) in 

16.123(b)(6)(ii)(c)(1)(ii), (c)(2), and 

(c)(3). 

NY needs to make the above changes 

in order to meet the Compatibility 

Category B designation assigned to 

Section 10 CFR 35.690. 

35 16.25 35.3045 2002-2 C Report and notification of a medical 

event 

NY’s regulation omits “or tissue” after 

“organ” in 16.25(b)(1)(ii). 

NY omits the phrase “50 rem shallow 

dose equivalent to the skin” from 

16.25(b)(1)(ii). 

NY omits equivalent requirements of 

Section 10 CFR 35.3045 (a) (1) (ii) 

and (iii). 

NY needs to make the above changes 

in order to meet the Compatibility 

Category C designation assigned to 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

Section 10 CFR 35.3045. 

36 16.15 35.3047 2002-2 C Report and notification of a dose to 

an embryo/fetus or a nursing child 

NY omits an equivalent provision to 

35.3047(b)(2) from their regulation. 

NY allows for 30 days for submission 

of the written report in 16.15(c)(1). 

NRC requires a written report within 

15 days. 

NY omits an equivalent section to 

Section 10 CFR 35.3047(e) and (f)(2) 

from their regulations 

NY needs to make the above changes 

in order to meet the Compatibility 

Category C designation assigned to 

Section 10 CFR 35.3047. 

37 16.15(f) 35.3067 2002-2 C Report of a leaking source 

NY’s regulation omits the following 

from what the written report must 

include: leaking source model and 

serial number, if assigned, the 

radionuclide and its estimated activity, 

and the date of the test. 

NY needs to add the above to 16.15(f) 

in order to meet the Compatibility 

Category C designation assigned to 

Section 10 CFR 35.3067. 
STATE REGULATION STATUS

State: New York State Health Department Tra[5 amendment(s) reviewed is identified by a i Daat 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

Regula1997-5AdoptemergeML092

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

1993-2 Licensing and Radiation Safety Requirements for 

Irradiators Part 36 58 FR 7715 

07/01/1996 Final No Comments 

01/28/2000 

AdoptemergeML092
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 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 

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 

NYSHRegula1997-5AdoptemergeML092

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
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

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 

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 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

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 

Parts 20, 30, 40, 70 62 FR 39057 

08/20/2000 

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 

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 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

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 

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 

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 

*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 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

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 

*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 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

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 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.