ML19018A271
| ML19018A271 | |
| Person / Time | |
|---|---|
| Site: | 11006338 |
| Issue date: | 01/18/2019 |
| From: | David Skeen NRC/OIP |
| To: | Bruening D ViewRay Technologies |
| Savoy J | |
| References | |
| Download: ML19018A271 (3) | |
Text
United States of America 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).
NRC LICENSE NO.: PXB147.01 Page 1 of 3 NRC DOCKET NO.: 11006338 LICENSE EXPIRES: January 31, 2022 NRC FORM 250 (1-19)
Nuclear Regulatory Commission Washington, D.C. 20555 EXPORT LICENSE LICENSEE ULTIMATE CONSIGNEE(S) IN FOREIGN COUNTRY(IES)
INTERMEDIATE CONSIGNEE(S) IN FOREIGN COUNTRY(IES)
OTHER U.S. PARTY(IES) TO EXPORT Neither this license nor any right under this license shall be assigned or otherwise transferred in violation of the provisions of the Atomic EnergyAct of 1954, as amended.
This license is subject to the right of recapture or control by Section 108 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 and regulations of the Nuclear Regulatory Commission.
THIS LICENSE IS INVALID UNLESS SIGNED BELOW BY AUTHORIZED NRC REPRESENTATIVE NAME AND TITLE:
DATE OF ISSUANCE:
APPLICANT'S
REFERENCE:
Application Dated 11/16/18 ULTIMATE DESTINATION: Canada DESCRIPTION OF 10 CFR PART 110, APPENDIX P, BYPRODUCT MATERIALS TO BE EXPORTED, INCLUDING CONDITIONS AND NOTES (NOTE: SEE PAGE 3 FOR DEFINITIONS OF CATEGORY 1 AND CATEGORY 2)
David L. Skeen, Deputy Director Office of International Programs EXPORT LICENSE ViewRay Technologies, Inc.
2 Thermo Fisher Way Oakwood Village, OH 44146 Attn: Dave Breuning Best Theratronics Ltd.
413 March Road Ottawa, ON K2K 0E4 Canada (return to manufacturer)
None See page 2 Export of Category 1 quantities of Co-60 not to exceed 3,330 TBq, contained in sealed sources to Canada is authorized.
Licensee is responsible for compliance with all applicable export, 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 information required by 10 CFR § 110.32(d) and pertinent documentation required by 10 CFR § 110.32(g) 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 Pre-shipment Notifications.
This license replaces PXB147.00 and amends its authority by: 1) extending the expiration date from June 30, 2021 to January 31, 2022; 2) revising the end use of the Ultimate Consignee; and 3) adding three addresses to Other U.S. Party(ies) to Export.
January 18, 2019 David L. Skeen Digitally signed by David L. Skeen Date: 2019.01.18 13:47:16 -05'00'
PXB147.01 Page 2 of 3
[1]
[2]
Licensee has requested in writing from the U.S. Nuclear Regulatory Commission (NRC) to obtain specific consent from the importing countrys regulatory authority, NRC has received and considered government-to-government consent pursuant to 10 CFR §110.42(e)(3); and NRC has informed the licensee in writing, that it is authorized to ship the materials to the ultimate consignee specified.
[3]
DESCRIPTION OF 10CFR PART 110, APPENDIX P, BYPRODUCT MATERIALS TO BE EXPORTED, INCLUDING CONDITIONS AND NOTES OTHER U.S. PARTY(IES) TO EXPORT Continued:
The Regents of the University of California Los Angeles UCLA Radiation Safety Division 501 Westwood Plaza, Fourth Floor Westwood, CA 90095-1605 1.
University of Miami Sylvester Comprehensive Cancer Center 1475 NW 12th Avenue Miami, FL 33136 2.
Washington University in St. Louis Barnes Jewish Hospital: Siteman Cancer Center One Barnes Jewish Hospital Plaza St. Louis, MI 63110 3.
Licensee is prohibited from shipping 10 CFR Part 110 Appendix P Category 1 quantities of Co-60 to Canada for which government to government consent has not been requested and received until:
PXB147.01 Page 3 of 3 n
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 Material Category 1 Category 2 Terabequerels (TBq)
Curies (Ci)1 Terabequerels (TBq)
Curies(Ci)1 Americium-241 (Am-241) 60 1,600 0.6 16 Americium-241/Beryllium (Am-241/Be) 60 1,600 0.6 16 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 R 1 R 2 R n 1 1 AR 1 A R 2 AR n
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.