Attachment III - NHPP Permit.pdf

Department of Veterans Affairs

Date: February 9, 2021

From: Program Manager, VHA National Health Physics Program (NHPP) (11SPEC12)

Subj: VHA Permit Number 21-04234-01 (for radioactive materials use)

To: Director (553/00), John D. Dingell VA Medical Center, Detroit, Michigan

1. We are forwarding the attached Amendment No. 122. The amendment is issued based on your request of February 8, 2021, to approve Dr. Karen Mourtzikos for all 10 CFR 35.300 uses.

2. You should review the permit amendment carefully to ensure you understand current permit approvals and conditions. This permit is assigned program code 2120/3620 for limited-scope medical and research uses.

3. You may contact Kim Wiebeck at 850-293-9759, if you have any questions about this matter.

Thomas E. Huston, Ph.D., CHP Attachment

Memorandum

Thomas E.

Huston 490617

Digitally signed by Thomas E. Huston 490617 Date: 2021.02.09 10:34:54 -06'00'

Department of Veterans Affairs

Page 1 of 5 pages

MATERIALS PERMIT

Amendment No. 122 In accordance with VHA Directive 1105 and reliance on statements made by the applicant, permission is hereby granted to receive, possess, transfer, and store radioactive materials listed below, and to use this material for the purpose and at the places listed below.

Permittee

1. John D. Dingell VA Medical Center

2. 4646 John R. Street

Detroit, Michigan 48201

3. In accordance with your request of February 8, 2021, Permit Number 21-04234-01 is amended to read as follows.

4. Expiration date: May 31, 2026

5. Docket or Reference Number: 030-02050

6. Byproduct, source, and/or special nuclear material

7. Chemical and/or physical form

8. Maximum amount permittee may possess at any one time under this permit

A. Any byproduct material permitted by 10 CFR 35.100

A. Any A. As needed

B. Any byproduct material permitted by 10 CFR 35.200

B. Any except generators B. As needed

C. Any byproduct material permitted by 10 CFR 35.300

C. Any C. 1 curie (Ci)

D. Gadolinium 153 permitted by

10 CFR 35.500

D. Sealed sources (Isotope Product Laboratories, Inc., Model NES-8412, NES- 8426, or NES-8429)

D. 300 millicuries (mCi) per source not to exceed 1 Ci total

E. Hydrogen 3 E. Any E. 50 mCi

F. Carbon 14 F. Any F. 50 mCi

G. Phosphorus 32 G. Any G. 5 mCi

H. Sulfur 35 H. Any H. 5 mCi

I. Iodine 125 I. Any I. 50 mCi

J. Technetium 99m J. Liquid J. 100 mCi

9. Authorized Use.

A. Any uptake, dilution, and excretion study permitted by 10 CFR 35.100.

B. Any imaging and localization study permitted by 10 CFR 35.200.

C. Any use permitted by 10 CFR 35.300.

D. Diagnostic medical use of sealed sources permitted by 10 CFR 35.500 in compatible devices registered pursuant to 10 CFR 30.32(g).

E. through I. Research and development as defined in 10 CFR 30.4, including animal studies, instrument calibration, student instruction, and in vitro studies.

J. For shielding evaluations conducted by or under direct supervision of the Radiation Safety Officer.

MATERIALS PERMIT Permit Number: 21-04234-01

SUPPLEMENTARY SHEET Docket or Reference Number: 030-02050 Amendment No. 122

CONDITIONS

10. Permitted material may be used or stored only at the permittee’s facilities located at 4646 John R. Street, Detroit, Michigan.

11. The Radiation Safety Officer for this permit is Thomas J. Petrone, Ph.D. A written continuity plan for a qualified Radiation Safety Officer shall be kept current and be approved, annually, by the Radiation Safety Committee. If the Radiation Safety Officer permanently discontinues duties under this permit, the permittee shall immediately notify the National Health Physics Program. Permit activities must cease without a qualified Radiation Safety Officer who meets Nuclear Regulatory Commission requirements.

12. Permitted material is only authorized for use by, or under the supervision of:

A. Individuals permitted to work as an authorized user and/or authorized nuclear pharmacist in accordance with 10 CFR 35.13 and 35.14.

B. The following individuals are authorized users for the materials and uses indicated.

Authorized User Material and Use

Sherif Ibrahim, M.D. 35.100, 35.200

Prasada R. Kandula, M.D. 35.100, 35.200

Aiden Abidov, M.D., Ph.D. 35.200 (cardiology studies only)

Ramanjit Kaur, M.D. 35.200 (cardiology studies only)

Preeti Ramappa, M.D. 35.200 (cardiology studies only)

Rabih Touma, M.D. 35.200 (cardiology studies only)

Florence Prigent, M.D. 35.100, 35.200, 35.500

Saleem Azad, M.D. 35.100, 35.200, 35.300

George L. Figacz, M.D. 35.100, 35.200, 35.300

Sharon Helmer, M.D. 35.100, 35.200, 35.300

Karen Mourtzikos, M.D. 35.100, 35.200, 35.300

Khurshaid Alam, M.D. 35.100, 35.200, 35.300 (limited to oral administration of sodium iodide I-131)

Louan Cuzzort, M.D. 35.100, 35.200, 35.300 (limited to oral administration of sodium iodide I-131)

Louis Furicchia, M.D. 35.100, 35.200, 35.300 (limited to oral administration of sodium iodide I-131)

Nicholas Lewis, M.D. 35.100, 35.200, 35.300 (limited to oral administration of sodium iodide I-131)

James F. Mastromatteo, M.D. 35.100, 35.200, 35.300 (limited to oral administration of sodium iodide I-131)

Gassan Shahin, M.D. 35.100, 35.200, 35.300 (limited to oral administration of sodium iodide I-131)

Karan Singh, M.D. 35.100, 35.200, 35.300 (limited to oral administration of sodium iodide I-131)

Zhen Wu, M.D. 35.100, 35.200, 35.300 (limited to oral administration of sodium iodide I-131)

Timothy J. Hadden, Ph.D. Items 6E, 6F, 6G, 6H

Mary A. Kosir, M.D. Items 6E, 6G, 6H

Anjaneyulu Kowluru, Ph.D. Items 6E, 6F, 6G, 6H, 6I

Donald Kuhn, Ph.D. Items 6E, 6G, 6H

Adhip N. Majumdar, Ph.D. Items 6E, 6F, 6G, 6H

Arun Rishi, Ph.D. Items 6G, 6H

Noreen F. Rossi, M.D. Items 6E, 6G, 6H, 6I

SUPPLEMENTARY SHEET Docket or Reference Number: 030-02050 Amendment No. 122

13. Permitted material shall not be used in or on humans except as provided otherwise by specific condition of this permit.

14. Permitted material shall not be used in field applications where activity is released except as provided otherwise by specific condition of this permit.

15. Experimental animals, or the products from experimental animals, that have been administered permitted material shall not be used for human consumption.

16. Sealed sources containing permitted material shall not be opened or sources removed from source holders by the permittee.

17. This permit does not authorize commercial distribution of permitted material.

18. For sealed sources not associated with 10 CFR 35 use, the following conditions apply.

A. Sealed sources shall be tested for leakage and/or contamination at intervals not to exceed the intervals specified by the certificate of registration issued by the Nuclear Regulatory Commission under 10 CFR 32.210 or under equivalent regulations of an Agreement State.

B. Notwithstanding Paragraph A of this permit condition, sealed sources designed to primarily emit alpha particles shall be tested for leakage and/or contamination at intervals not to exceed 3 months.

C. Each sealed source fabricated by the permittee shall be inspected and tested for construction defects, leakage, and contamination prior to any use or transfer as a sealed source.

D. In the absence of a certificate from a transferor indicating a leak test has been made within the intervals specified in the certificate of registration issued by the Nuclear Regulatory Commission under 10 CFR 32.210 or under equivalent regulations of an Agreement State, prior to the transfer, a sealed source received from another person shall not be put into use until tested and the test results received.

E. Sealed sources need not be tested if they contain only hydrogen 3, or they contain only a radioactive gas, or the half-life of the isotope is 30 days or less, or they contain not more than 100 microcuries of beta-and/or gamma-emitting material, or not more than 10 microcuries of alpha-emitting material.

F. Sealed sources need not be tested if they are in storage and are not being used; however, when they are removed from storage for use or transfer to another person, and have not been tested within the required leak test interval, they shall be tested before use or transfer. No sealed source shall be stored for a period of more than 10 years without being tested for leakage and/or contamination.

G. The leak test shall be capable of detecting the presence of 0.005 microcurie (185 becquerels) of radioactive material on the test sample. If the test reveals the presence of 0.005 microcurie (185 becquerels) or more of removable contamination, a report shall be filed with the National Health Physics Program in accordance with 10 CFR 30.50I(2), and the source shall be removed immediately from service and decontaminated, repaired, or disposed of in accordance with Nuclear Regulatory Commission regulations.

H. Tests for leakage and/or contamination, including leak test sample collection and analysis, shall be performed by the permittee or by other persons specifically licensed by the Nuclear Regulatory Commission or an Agreement State to perform such services.

SUPPLEMENTARY SHEET Docket or Reference Number: 030-02050 Amendment No. 122

19. A. The permittee shall conduct physical inventories to account for all sealed sources and/or devices received and possessed under this permit.

(1) Quarterly, for sealed sources with either current activity greater than 1 millicurie or current activity greater than 1000 times the quantities in 10 CFR 20, Appendix C.

(2) Semiannually, for all other sealed sources, except sources specifically exempted by 10 CFR 30.

B. The permittee shall maintain records for 3 years from the date of each inventory and include the radionuclides, quantities, manufacturer’s name and model numbers, location of the sources and/or devices, and the date of the inventory.

C. The permittee shall classify sealed sources, not in active use for their intended clinical or research purpose for a period of 24 months, as disused sources and evaluate the disused sources for disposal as expeditiously as possible.

D. The permittee shall provide oversight for security of radioactive materials by:

(D) Compliance with regulations per 10 CFR 20.1801 and 10 CFR 20.1802.

(2) Prevention of adversary or unauthorized removal of, or access to, radioactive materials.

(3) Use of two delay methods for sealed sources not in use.

(4) Focus to security commensurate with possible risks of radioactive materials unauthorized use.

20. A. Detector cells containing a titanium tritide foil or a scandium tritide foil shall only be used in conjunction with a properly operating temperature control mechanism, which prevents the foil temperature from exceeding that specified by the manufacturer and approved by the Nuclear Regulatory Commission.

B. When in use, detector cells containing a titanium tritide foil or a scandium tritide foil shall be vented to the outside.

21. Maintenance, repair, cleaning, replacement, and disposal of foils contained in detector cells shall be performed only by the device manufacturer or other persons specifically authorized by the Nuclear Regulatory Commission or an Agreement State to perform such services.

22. For radioactive material held for decay in storage other than that held in accordance with 10 CFR 35.92, the permittee is authorized to hold radioactive material with a physical half-life of less than 120 days for decay in storage before disposal in ordinary trash, provided:

D. Before disposal as ordinary trash, the waste shall be surveyed at the container surface with the appropriate survey instrument set on its most sensitive scale and with no interposed shielding to determine its radioactivity cannot be distinguished from background. All radiation labels shall be removed or obliterated.

B. A record of each such disposal permitted under this permit condition shall be retained for 3 years. The record must include the date of disposal, the date on which the byproduct material was placed in storage, the radionuclides disposed, the survey instrument used, the background dose rate, the dose rate measured at the surface of each waste container, and the name of the individual who performed the disposal.

23. The permittee is authorized to transport permitted material in accordance with the provisions of 10 CFR 71, “Packaging and Transportation of Radioactive Material.”

SUPPLEMENTARY SHEET Docket or Reference Number: 030-02050 Amendment No. 122

24. Pursuant to 10 CFR 20.2002, the permittee may dispose of emptied scintillation vials, which previously contained Sulfur 35, as normal waste, subject to the survey and sampling commitments in the letter dated February 17, 1995 (excluding Item (1) under the heading “Disposal of Contaminated Vial Batches”).

25. Except as specifically provided otherwise in this permit, the permittee shall conduct its program in accordance with the statements, representations, and procedures contained in the documents, including any enclosures, listed below. This permit condition applies only to those procedures required to be submitted in accordance with the regulations. Additionally, this permit condition does not limit the permittee’s ability to make changes to the radiation protection program as provided for in 10 CFR 35.26. The Nuclear Regulatory Commission regulations shall govern unless the statements, representations, and procedures in the permittee’s application and correspondence are more restrictive than the regulations.

A. February 18, 2016, Final Renewal Application B. April 5, 2017, Email, w/atch [approve AU, Aiden Abidov, M.D., Ph.D.] C. May 17, 2017, Memorandum [remove AUs (Drs. Sherpa, Mathew, Katukuri, Kaatz, Fontana, and Miller); remove Phosphorus 33] D. December 11, 2017, Memorandum [change RSO from Rayma L. Bilicki—temporary] E. February 9, 2018, Email [add Room C3514 as area of use] F. February 28, 2018, Memorandum w/atchs [change RSO from Mastromatteo] G. December 20, 2018 Letter w/atchs [add AUs - Drs. Cuzzort, Furicchia, Lewis, Shahin, Singh, Wu] H. June 4, 2019, Letter w/atch [add AU - Dr. Kaur] I. December 1, 2020, Letter w/atch [add AU – Dr. Mourtzikos] J. February 8, 2021, Letter w/atch [approve AU Dr. Mourtzikos for all 35.300]

FOR THE DEPARTMENT OF VETERANS AFFAIRS

Date February 9, 2021 By Thomas E. Huston, Ph.D., CHP Program Manager, National Health Physics Program North Little Rock, Arkansas

Thomas E.

Huston 490617

Digitally signed by Thomas E.

Huston 490617 Date: 2021.02.09 10:38:34 -06'00'