ML21336A193

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EMAIL-SHINE Amendment - Changes to Construction Permit No. CPMIF-001 for Possession and Receipt of Radioactive Materials
ML21336A193
Person / Time
Site: SHINE Medical Technologies
Issue date: 12/02/2021
From: Jim Costedio
SHINE Medical Technologies
To: Michael Balazik
NRC/NRR/DANU/UNPL
Balazik M, NRR/DANU/UNPL, 415-2856
References
Download: ML21336A193 (3)


Text

From: Jim Costedio To: Balazik, Michael Cc: Jeff Bartelme; Borromeo, Joshua; Lynch, Steven; Gavello, Molly-Kate

Subject:

[External_Sender] RE: [EXTERNAL] SHINE Amendment - Changes to Construction Permit No. CPMIF-001 Date: Thursday, December 2, 2021 7:51:42 AM Mike, SHINE has reviewed the proposed changes to Construction Permit CPMIF-001 and is in agreement with the changes.

I declare under the penalty of perjury that the foregoing is true and correct.

Executed on December 2, 2021.

Jim Costedio JIM COSTEDIO VP, REGULATORY AFFAIRS & QUALITY SHINE Technologies From: Balazik, Michael <Michael.Balazik@nrc.gov>

Sent: Wednesday, December 1, 2021 3:44 PM To: Jeff Bartelme <Jeff.Bartelme@shinemed.com>

Cc: Gavello, Molly-Kate <Molly-Kate.Gavello@nrc.gov>; Borromeo, Joshua

<Joshua.Borromeo@nrc.gov>; Lynch, Steven <Steven.Lynch@nrc.gov>

Subject:

[EXTERNAL] SHINE Amendment - Changes to Construction Permit No. CPMIF-001 Disclaimer This email originated from outside the organization. Do not click links or open attachments unless you recognize the sender and know the content is safe.

Jeff, The NRC staff determined that minor changes to the proposed new conditions 3.E and 3.F were necessary for accuracy and clarity for the staff to find the conditions acceptable. The proposed new conditions, with the NRCs staffs deletions in strike-through and additions in underline, would state:

E. Pursuant to the Act and 10 CFR Part 30, the following activities are

includedauthorized:

1. to receive and possess, in connection with construction of the facility, up to [ ]SRI of sealed americium-241 beryllium neutron sources in amounts up to those specified on page 3 of the SHINE Medical Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 dated April 29, 2021, as supplemented on August 20, 2021.

F. Pursuant to the Act and 10 CFR Part 40, the following activities are includedauthorized:

1. to receive and possess, in connection with construction of the facility, up to 10,000 kilograms (kg) of natural uranium in the form of neutron multipliers; and
2. to receive and possess, in connection with construction of the facility, up to 10 kg of depleted uranium in the form of tritium storage beds.

The NRC staff also determined that the addition to the construction permit of a new finding would be necessary to memorialize the acceptability of proposed new conditions 3.E and 3.F. Specifically, new paragraph 1.K to Construction Permit CPMIF-001 would state:

The receipt and possession of byproduct and source material as authorized by this license will be in accordance with the Commissions regulations in 10 CFR Parts 30 and 40.

Please respond to this email under oath or affirmation whether SHINE agrees with these changes to Construction Permit CPMIF-001 or whether SHINE proposes different changes. Please call if you have any questions.

Best Regards, Michael Balazik Project Manager/Inspector Non-Power Production and Utilization Facility Licensing Office of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission Michael.Balazik@nrc.govl Tel: (301) 415-2856 This message and accompanying documents are covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521, and may contain confidential information for the specified individual(s) only. If you are not the intended recipient, you are hereby notified that you have received this document in error and that any review, dissemination, copying, or the taking of action based on the contents of this information is strictly prohibited. If you have received this communication in error, please notify the sender immediately by e-mail, and delete the message.

This message and accompanying documents are covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521, and may contain confidential information for the specified individual(s) only. If you are not the intended recipient, you are hereby notified that you have received this document in error and that any review, dissemination, copying, or the taking of action based on the contents of this information is strictly prohibited. If you have received this communication in error,

please notify the sender immediately by e-mail, and delete the message.