ML23299A224

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Export License Issued to International Isotopes Inc PXB190a.03
ML23299A224
Person / Time
Site: 11006160
Issue date: 10/26/2023
From: David Skeen
NRC/OIP
To: John Miller
International Isotopes Idaho
References
Download: ML23299A224 (1)


Text

EXPORT LICENSE NRC FORM 250 NRC LICENSE NO.: PXB190a.03 United States of America Page 1 of 3 Nuclear Regulatory Commission NRC DOCKET NO.: 11006160 Washington, D.C. 20555 LICENSE EXPIRES: October 31, 2033 Pursuant to the Atomic Energy Act of 1954, as amended, and the regulations issued by the Nuclear Regulatory Commission (NRC) pursuant thereto, and in reliance on statements and representations heretofore made by the applicant/licensee, this license is hereby issued authorizing the licensee to export of the byproduct materials listed below, subject to the terms and conditions herein. This license is only valid if the licensee or 'Other Party (ies) to Export' maintain the requisite NRC or Agreement State domestic license(s).

LICENSEE ULTIMATE CONSIGNEE(S) IN FOREIGN COUNTRY(IES)

International Isotopes Inc. See page 2 4137 Commerce Circle Idaho Falls, ID 83401 Attn: John J. Miller INTERMEDIATE CONSIGNEE(S) IN FOREIGN COUNTRY(IES) OTHER U.S. PARTY(IES) TO EXPORT None None APPLICANT'S

REFERENCE:

Application Dated 08/29/23 ULTIMATE DESTINATIONS: See page 2 DESCRIPTIONS OF 10CFR PART 110, APPENDIX P, BYPRODUCT TO BE EXPORTED, INCLUDING CONDITIONS AND NOTES (NOTE:SEE PAGE 3 FOR DEFINITIONS OF CATEGORY 1AND CATEGORY 2)

Export of Category 1 quantities of Co-60 (940 TBq max per shipment) for radiotherapy, gamma irradiation, and research to "Ultimate Destination(s)" when the conditions on page 2 of this license are met. For Category 1 exports, see conditions on page 2.

Export of Category 2 quantities of Co-60 for radiography, gamma irradiation, and research is authorized to countries listed as "Ultimate Destinations."

Licensee is responsible for compliance with all applicable export requirements, and other domestic regulatory requirements, including all terms and conditions of domestic material possession licenses.

Licensee, if not already submitted with your application, must submit pertinent documentation required by 10 CFR 110.32(g) and 110.50(c) at least 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> prior to shipment, see page 3 for Mandatory Advanced Notifications.

This license replaces PXB190a.02 and amends its authority by: 1) revising the list of countries in "Ultimate Destinations," 2) removing Best Medical International and Washington University of St. Louis Barnes-Jewish Hospital as "Other Party(ies) to Export," 3) listing the addresses of two additional Ultimate Consignee(s) in Foreign Country(ies); 4) removing cesium-137, and; 5) extending the expiration date of the license from June 30, 2023 to October 31, 2033.

Neither this license nor any right under this license shall be assigned or THIS LICENSE IS INVALID UNLESS SIGNED BELOW otherwise transferred in violation of the provisions of the Atomic BY AUTHORIZED NRC REPRESENTATIVE Energy Act of 1954, as amended. David L. Digitally signed by David L. Skeen NAME AND TITLE: Skeen Date: 2023.10.26 13:51:24 -04'00' This license is subject to the right of recapture or control by Section 108 David L. Skeen, Director of the Atomic Energy Act of 1954, as amended, and to all the other provisions of said Acts, now or hereafter in effect and to all valid rules Office of International Programs and regulations of the Nuclear Regulatory Commission.

DATE OF ISSUANCE:

EXPORT LICENSE

PXB190a.03 Page 2 of 3 CONDITIONS Licensee is prohibited from shipping Category 1 quantities of Co-60 to Canada, Germany, and Sweden, until government-to-government consent has been requested, received, and processed. Specifically:

a. The licensee must submit a consent request to the NRC with pertinent details for a specific shipment or series of shipments on the NRC Form 7, which notifies the NRC to request and obtain consent for the specified transactions(s) from the importing country's regulatory authority;
b. Shipment may only proceed after the NRC has informed the licensee in writing that the consent request has been granted, authorizing the transfer of materials to the ultimate consignee(s) specified on the NRC Form 7 consent request.

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1. Best Theratronics 2. Gamma-Services Recyling GMBH 413 March Road Bautzner STR. 67 Ottawa, ON, Canada K2K 0E4 Leipzig, Germany 04347 (radiotherapy, gamma irradiation, and research) (radiotherapy, gamma irradiation, and research)

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&DWHJRU\1TXDQWLWLHVRICo-60

3. Studsvik Nuclear AB Atomvagen 1 610 60 Tysberga Sweden (radiotherapy, gamma irradiation, and research)

ULTIMATE DESTINATION(S):

Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Estonia, Ethiopia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Kazakhstan, Republic of Korea, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Mexico, Namibia, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Romania, Russia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom and Vietnam.

PXB190a.03 Page 3 of 3 MANDATORY ADVANCED NOTIFICATIONS PER 10 CFR PART 110.50(c)

The following Advanced Notifications must be made to both the NRC and, in case of exports, the government of the importing country in advance of each shipment:

Mandatory Advanced Notifications to the NRC are to be emailed to hoo.hoc@nrc.gov (preferred method) or faxed to the NRC at 301-816-5151. In the subject line of the email or on the fax cover page include: "10 CFR 110.50(c)

Notification." For technical assistance, use the same e-mail address or call 301-287-9056.

Mandatory Advanced Notifications to the government of the importing country must be emailed or faxed to the appropriate foreign government authorities. To locate the point-of-contact for international Advanced Notifications see: http://www-ns.iaea.org/downloads/rw/imp-export/import-export-contact-points.pdf. In the subject line of the email or on the fax cover page include: "NOTIFICATION TO THE IMPORTING STATE PRIOR TO SHIPMENT OF CATEGORY 1 OR 2 RADIOACTIVE SOURCES. For technical assistance or for countries not listed, contact the Office of International Programs export/import staff at 301-287-9056.

Table 1: Appendix P to Part 110 Category 1 and Category 2 Radioactive Material Threshold Limits Radioactive Category 1 Category 2 Material Terabequerels (TBq) Curies (Ci)1 Terabequerels (TBq) Curies(Ci)1 Americium-241 (Am-241) 60 1,600 0.6 16 Americium-241/Beryllium (Am- 60 1,600 0.6 16 241/Be)

Californium-252 (Cf-252) 20 540 0.2 5.4 Curium-244 (Cm-244) 50 1,400 0.5 14 Cobalt-60 (Co-60) 30 810 0.3 8.1 Cesium-137 (Cs-137) 100 2,700 1.0 27 Gadolinium-153 (Gd-153) 1,000 27,000 10.0 270 Iridium-192 (Ir-192) 80 2,200 0.8 22 Plutonium-2382 (Pu-238) 60 1,600 0.6 16 Plutonium-239/Beryllium2 (Pu-239/Be) 60 1,600 0.6 16 Promethium-147 (Pm-147) 40,000 1,100,000 400 11,000 Radium-2263 (Ra-226) 40 1,100 0.4 11 Selenium-75 (Se-75) 200 5,400 2.0 54 Strontium-90 (Y-90) 1,000 27,000 10.0 270 Thulium-170 (Tm-170) 20,000 540,000 200 5,400 Ytterbium-169 (Yb-169) 300 8,100 3.0 81 Calculation of Shipments Containing Multiple Sources or Radionuclides:

The sum of fractions methodology for evaluating combinations of radionuclides being transported is to be used when import or export shipments contain multiple sources or multiple radionuclides. The threshold limit values used in a sum of the fractions calculation must be the metric values (i.e., TBq).

I. If multiple sources and/or multiple radionuclides are present in an import or export shipment, the sum of the fractions of the activity of each radionuclide must be determined to verify the shipment is less than the Category 1 or 2 limits of Table 1, as appropriate. If the calculated sum of the fractions ratio, using the following equation, is greater than or equal to 1.0, then the import or export shipment exceeds the threshold limits of Table 1 and the applicable security provisions of this part apply.

II. Use the equation below to calculate the sum of the fractions ratio by inserting the actual activity of the applicable radionuclides or of the individual sources (of the same radionuclides) in the numerator of the equation and the corresponding threshold activity limit from the Table 1 in the denominator of the equation. Ensure the numerator and denominator values are in the same units and all calculations must be performed using the TBq (i.e., metric) values of Table 1.

R1 = activity for radionuclides or source number 1 AR1 = activity limit for radionuclides or source number 1 R2 = activity for radionuclides or source number 2 AR2 = activity limit for radionuclides or source number 2 RN = activity for radionuclides or source number n ARN = activity limit for radionuclides or source number n n

R 1 R2 R n A R AR2 AR n 1

1 1 1 The values to be used to determine whether a license is required are given in TBq. Curie (Ci) values are provided for practical usefulness only and are rounded after conversion.

2 The limits for exports of Pu-238 and Pu-239/Be can be found in § 110.21.

3 Discrete sources of Radium-226.