ML23205A181
| ML23205A181 | |
| Person / Time | |
|---|---|
| Issue date: | 07/25/2023 |
| From: | Adelaide Giantelli NRC/NMSS/DMSST/ASPB |
| To: | Mcburney R Conference of Radiation Control Program Directors (CRCPD) |
| References | |
| Download: ML23205A181 (15) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 Ruth E. McBurney Executive Director Conference of Radiation Control Program Directors, Inc.
201 Brighton Park Blvd, Suite 1 Frankfort, KY 40601
Dear Ruth McBurney:
We reviewed the proposed revisions to the Suggested State Regulations (SSRs) in Part G, Use of Radionuclides in the Healing Arts, received by our office on March 6, 2023. These regulations were reviewed by comparison to the equivalent U.S. Nuclear Regulatory Commission (NRC) rules in Title 10 of the Code of Federal Regulations Part 35, as applicable.
We discussed our review of the regulations with you on July 18, 2023.
As a result of our review, we have 17 comments and 8 editorial comments that have been identified in Enclosure 1. We have determined that if the SSR Part G were revised to incorporate 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 a copy of the revised SSR Part G be provided to us for review and federal concurrence. As requested in Office of Nuclear Material Safety and Safeguards (NMSS)
Procedure SA-201, Review of State Regulatory Requirements, please highlight the final changes.
The State Regulation Status (SRS) Data Sheet in Enclosure 2 summarizes our knowledge of the status of other Conference of Radiation Control Program Directors (CRCPD) SSRs, 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 NRC website https://www.nrc.gov/materials/toolboxes/regulation/crcpd-suggestions.
July 25, 2023
R. McBurney 2
If you have any questions regarding the review, the compatibility and health and safety categories, or any of the NRC regulations used in the review, please contact my staff at AgreementStateRegs.Resource@nrc.gov.
Sincerely, Adelaide S. Giantelli, Chief State Agreement and Liaison Programs Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosures:
- 1. Compatibility and Editorial Comments
ML23067A385 and ML23205A181 letter OFFICE NMSS/MSST NMSS/MSST OGC NMSS/MSST NAME HAkhavannik SSahle BHarris AGiantelli DATE 07/24/2023 07/24/2023 07/18/2023 07/25/2023 COMPATIBILITY COMMENTS ON CRCPD PROPOSED REGULATIONS STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 1
G.2
§35.2 N/A B
Definitions For the definition of, authorized medical physicist, the reference to G.51 should be updated to G.51(a).
The word or should be removed at the end of G.51b(i). Under G51b(iv),
the word license should be added after master material.
For the definition of, authorized nuclear pharmacist, update the phrase G.55a or G.59 to say G.55a and G.59.
These changes need to be done to meet the Compatibility Category B designation assigned to 10 CFR 35.2.
2 G.11a
§35.11(a)
N/A
[C]
License required CRCPD G.11a includes a reference to G.11c. CRCPD needs to update G.11a to remove the reference to G.11c that is currently reserved and because G.11c is designated a NRC compatibility category and cannot be adopted by the Agreement States.
3 G.27
§35.27 N/A H&S Supervision CRCPD G.27c references paragraphs G.21a and G.21b but needs to be corrected to reference G.27a and G.27b.
These references need to be corrected to meet the Compatibility Category H&S designation for 10 CFR 35.27.
4 G.30 N/A N/A N/A Duties of Authorized User and Authorized Medical Physicist
2 STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS CRCPD G.30.c(i) states that only the authorized medical physicists (AMP) or designee perform the periodic spot checks as described in G.642, G.643, G.645. However, this conflicts with G.642.b, G.643.b, and G.645.b(i),
which state that the AMP need not perform the periodic spot checks.
This conflict needs to be resolved to ensure consistent regulatory compliance.
5 G.50
§35.50 N/A B
Training for Radiation Safety Officer CRCPD G.50b.i.2 states, master materials license but needs to be corrected to state, master materials licensee.
This needs to be corrected to meet the Compatibility Category B designation for 10 CFR 35.50.
6 G.51
§35.51 N/A B
Training for an authorized medical physicist G.51a includes the Nuclear Regulatory Commission or an Agreement State but needs to be corrected to state, Agency, the Nuclear Regulatory Commission or an Agreement State.
This needs to be corrected to meet the Compatibility Category B designation for 10 CFR 35.51.
7 G.67a, b, c, e, & g
§35.67(a), (b),
(c), (e), & (g)
N/A H&S Requirements for possession of sealed sources and brachytherapy sources CRCPD G.67.c states that the
3 STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS samples leak test must be measured to, detect the presence of 185 becquerels (0.005 µCi) or more of radioactive material in the sample, whereas 10 CFR 35.67(b)(2)(c) does not specify or more.
G.67.c needs to be updated to remove, or more, to meet the Compatibility Category H&S designation assigned to 10 CFR 35.67(b).
8 G.75b
§35.57(b)
N/A C
Release of individuals containing unsealed byproduct material or implants containing byproduct material CRCPD G.75b states, A licensee shall provide the released individual, or the individual's parent or guardian, with instructions, including oral and written instructions while 10 CFR 35.57(b) does not specify oral.
Including the option to provide oral instructions is less restrictive. CRCPD G.75b needs to be updated to say including both oral and written or to remove oral to meet the Compatibility Category C designation for 10 CFR 35.57.
9 G.200
§35.200 N/A H&S Use of unsealed byproduct material for imaging and localization for which a written directive is not required CRCPD G.200.a.ii references C.28h but it should reference C.24h.
Additionally, G.200.b.iii references G.290.b.i and G.290.b.ii but should reference G.200.b.i and G.200.b.ii.
4 STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS These references need to be corrected to meet the Compatibility Category H&S designation assigned to 10 CFR 35.200.
10 G.290
§35.290 N/A B
Training for imaging and localization studies G.290.b is missing the equivalent to the phrase found in 10 CFR 35.290(b), and meets the requirements in §35.290(c)(1)(ii)(G).
G.290.b needs to be updated to add, and meets the requirements in G.290.c.ii.2.g to meet the Compatibility Category B designation assigned to 10 CFR 35.290.
G.290.c.ii does not include the word independently and needs to be updated to say, individual has satisfactorily completed the requirements in G.290c.i and is able to independently fulfill... This is required to meet the Compatibility Category B designation assigned to 10 CFR 35.290.
11 G.310a
§35.310(a)
N/A H&S Safety instruction G.310.a says, To satisfy this agreement, the instruction shall be appropriate with while 10 CFR 35.310a says, To satisfy this requirement, the instruction must be commensurate with. G.310a needs to be updated to say, commensurate with to meet the H&S Compatibility Category assigned to 10 CFR 35.310(a).
12 G.415
§35.415 N/A H&S Safety precautions
5 STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS G.415(b)(1) needs to be changed to include an and at the end of the phrase instead of an or to meet the H&S Compatibility Category assigned to 10 CFR 35.415.
13 G.610
§35.610 N/A H&S Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units G.610.g needs to be updated to reference G.610d.ii.2 in G.610.g instead of G.610d.ii to meet the H&S Compatibility Category assigned to 10 CFR 35.610(g).
14 G.633
§35.633 N/A H&S Full calibration measurements on remote afterloader units G.633d need to be updated to reference G.633.a instead of G.630a to meet the H&S Compatibility Category assigned to 10 CFR 35.633.
15 G.645
§35.645 N/A H&S Periodic spot-checks for gamma stereotactic radiosurgery units G.645.b.ii needs to remove the phrase, required by G.645a.i. as it limits the spot checks to only those performed monthly.
This change needs to be done to meet the H&S Compatibility Category assigned to 10 CFR 35.645.
16 G.3045
§35.3045 N/A C
Report and notification of a medical event G.3045a.ii.1 needs to remove the, outside of the treatment site, phrase to meet the essential objective of 10 CFR 35.3045(a)(2)(i) and meet the
6 STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS Compatibility Category C assigned to 10 CFR 35.3045.
17 G.3047
§35.3047 N/A C
Report and notification of a dose to an embryo/fetus or a nursing child G.3047b needs to remove the phase, that was not specifically approved, in advance, by the authorized user, as it makes the requirement less restrictive and does meet the essential objective of 10 CFR 3047(b).
These changes must be done in order to meet the Compatibility Category C assigned to 10 CFR 35.3047.
7 EDITORIAL COMMENTS ON CRCPD PROPOSED REGULATIONS STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 1
G.14
§35.14 N/A D
CRCPD needs to correct G.14.a.i.(2) which describes any additional case experience required for an authorized user under G.390 when it should be G.300.
2 G.65
§35.65 N/A D
Authorization for calibration, transmission and reference sources G.65.a.ii contains the phrase, [a]ny radioactive material with a half-life of not longer then 120 days in individual amounts not to exceed 0.56 gigabecquerels (15 mCi). This should be a separate G.65.a.iii regulation.
The current G.65.iii should be updated to G.65.a.iv.
3 G.190
§35.190 N/A B
Training for uptake, dilution and excretion studies Consider updating G.190.a to replace Toolbox webpage to Toolkit webpage.
4 G.392
§35.392 N/A 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)
Consider updating the title of G.392 to, 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) to match §35.392.
5 G.394
§35.394 N/A B
Training for the oral administration of sodium iodide I-131 requiring a
8 STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries)
Consider updating the title of G.394 to, Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries) to match §35.394.
6 G.433
§35.433 N/A N/A Strontium-90 sources for ophthalmic treatments Consider updating the title of the section to remove decay of before Strontium-90. The section title was changed in 2014 to reflect expanded information and requirements.
7 G.610
§35.610 N/A H&S Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units Consider updating G.610.a.iv to say,
[t]hese procedures must include instead of [t]his procedure to reflect the possibility of multiple procedures.
8 G.3045 G.3047 G.3067
§35.3045
§35.3047
§35.3067 N/A C
Consider updating G.3045d, G.3047d, and G.3067 to include CRCPDs Suggested State Regulation A.12 Communications which is the equivalent to 10 CFR 30.6(a).
CRCPD STATE SUGGESTED REGULATION STATUS SHEET
[amendment(s) reviewed identified by a
- at the Tracking Ticket Number: 23-20 beginning of the equivalent NRC requirement.]
DATE: July 25, 2023 CRCPD PART/
TITLE NRC REGULATION-10 CFR Parts PROPOSED/
REVISED/FINAL FEDERAL CONCURRENCE GIVEN? Yes/No DATE OF DOCUMENT/ADAMS ML# of Package COMMENTS A-General Provisions 19, 20, 30, 31, 32, 34, 35, 36, 39, 40, 61, 70, 71, and 150.
Proposed-comments Revised-Comments Revised-No comments No 3/30/11 ML110610112 No 02/28/22 ML22026A343 Yes 04/18/22 ML22101A174 The submitted Part A SSRs were updated to reflect the changes related to 10 CFR Parts 19 and 20 through RATS ID 2021-1.
B-Regulation of Radiation Machine Facilities and Assoc.
Healthcare Professionals N/A C-Licensing of Radioactive Material 30, 31, 32, 40, 70 Final; no comments Proposed; Comments Final; No Comments Yes 5/12/10 ML101040766 No 05/01/19 ML19044A444 Yes 8/26/21 ML21235A111 D-Standards for Radiation Protection 20 Proposed; Comments Revised; Comments No 3/30/11 ML110610112 No 02/28/22 The submitted Part D SSRs were updated to reflect the
2 Revised-No comments ML22026A343 Yes 04/18/22 ML22101A174 changes through RATS ID 2021-1.
E-Radiation Safety Requirements for Industrial Radiography Operations 34 Final; no comments Revised; no comments Yes 2/22/16 ML16036A047 Yes 12/13/21 ML21330A073 The submitted Part E SSRs were updated to reflect the changes through RATS ID 2020-1.
F-Medical Diagnostic and Interventional X-Rays and Imaging Systems N/A
- G-Use of Radionuclides in the Healing Arts 35 Proposed; comments Revised; comments No 4/1/10 ML100600666 No 07/25/2023 ML23067A385 H-Radiation Safety Requirements for non-medical radiation generating devices N/A J-Notices, Instructions and Reports to Workers, Inspections 19 Proposed; comments Revised; comments Revised; No comments No 3/30/11 ML110610112 No 02/28/22 ML22026A343 Yes 04/18/22 ML22101A174 The submitted Part J SSRs were updated to reflect the changes through RATS ID 2020-3.
N-Regulation and Licensing of TENORM N/A
3 O-Decommissioning 30, 40, 70 Final; no comments Revised; no comments Yes 11/13/00 ML003770059 Yes 02/28/22 ML22026A343 The submitted Part O SSRs were updated to reflect the changes related to 10 CFR Part 20* through RATS ID 2011-1.
Q-Licensing and Radiation Safety Requirements for Irradiators 36 Proposed; no comments Revised; no comments Final; no comments No 7/11/15 ML051930005 Yes 12/13/21 ML21330A073 Yes 2/3/22 ML22026A430 The submitted Part Q SSRs were updated to reflect the changes through RATS ID 2020-1.
R-Control of Radiation Radon N/A S-Requirements for Financial Assurance 30, 40, 70 3/24/05 T-Transportation of Radioactive Material 71 Final; no comments Revised; comments Revised; No comments Yes 9/9/14 ML14093A159 No 03/31/22 ML22066A027 Yes 04/26/22 ML22101A127 The submitted Part T SSRs were updated to reflect the changes through RATS ID 2021-2.
U-Licensing Requirements for Uranium and Thorium Processing and related radioactive materials 40 Final; no comments Yes 4/16/15 ML15077A212
4 V-Physical Protection of Category I & II Quantities of Radioactive Materials 37 Final; no comments Revised; comment Final; No comments Yes 11/19/14 ML14294A568 No 12/13/21 ML21330A073 Yes 2/3/22 ML22026A430 The submitted Part V SSRs were updated to reflect the changes through RATS ID 2021-2.
W-Radiation Safety Requirements for Well Logging Operations and Subsurface Tracer Studies 39 Proposed; comments Revised; Comments Final; No comments No 1/30/15 ML14279A456 No 12/13/21 ML21330A073 Yes 2/3/22 ML22026A430 The submitted Part W SSRs were updated to reflect the changes through RATS ID 2020-1.
X-Therapeutic Radiation machines N/A Z-Medical Credentialing N/A