ML24038A345
| ML24038A345 | |
| Person / Time | |
|---|---|
| Site: | 11006070 |
| Issue date: | 02/07/2024 |
| From: | Sabrina Atack NRC/OIP |
| To: | Desgagne L Nordion (Canada) |
| References | |
| Download: ML24038A345 (1) | |
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).
July 31, 2030 LICENSE EXPIRES:
NRC DOCKET NO.: 11006070 Page 1 of 5 PXB3.15 NRC LICENSE NO.:
NRC FORM 250 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 Energy Act 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:
PXB3.14 AMEND1-2023 ULTIMATE DESTINATION: Canada Sabrina D. Atack, Deputy Director Office of International Programs EXPORT LICENSE Nordion (Canada) Inc.
447 March Road Ottawa, Ontario, K2K 1X8 Canada Attn: Luc Desgagne Nordion (Canada), Inc.
447 March Road Ottawa, Ontario, K2K 1X8 Canada (supplier)
None See following page(s)
CONDITIONS, DESCRIPTIONS OF 10CFR PART 110, APPENDIX P, BYPRODUCT MATERIALS TO BE EXPORTED, INCLUDING CONDITIONS AND NOTES (NOTE: SEE PAGE 5 FOR DEFINITIONS OF CATEGORY 1 AND CATEGORY 2)
Export to Nordion (Canada) Inc., of Category 1 and Category 2 quantities of Co-60, contained in sealed sources for disposition in Canada, is authorized. See conditions on Page 5.
Licensee is responsible for compliance with all applicable export and other domestic regulatory requirements, including all terms and conditions of domestic material license(s).
Licensee must submit 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 5 for Mandatory Advanced Notifications.
Export license amendment PXB3.15 supersedes export license PXB3.14 by: revising the addresses of U.S. Party #29 and U.S. Party #30; adding a new U.S. Party, #47; and making administrative changes for consistency in address format.
February 7, 2024 Sabrina D. Atack Digitally signed by Sabrina D. Atack Date: 2024.02.07 12:50:58 -05'00'
PXB3.15 Page 2 of 5
[1]
Licensee is prohibited from shipping Category 1 quantities of Co-60 to Canada until government-to-government consent has been requested, received and processed.
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;
[2]
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.
[3]
CONDITIONS OTHER U.S. PARTY(IES) TO EXPORT Continued:
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3M Company 601 22nd Avenue South Brookings, SD 57006 Baxter Healthcare of Puerto Rico State Road 721, Km 0.3 Aibonito, PR 00705 Becton Dickinson Infusio Therapy Systems, Inc.
150 South 1st Avenue Broken Bow, NE 68822 Becton, Dickinson, and Company dba BD Medical Systems - Diabetes Care 1329 West Highway 6 Holdrege, NE 68949 Department of the Army Commander White Sands Missile Range NM 88002 Isomedix Operations, Inc.
dba STERIS Applied Sterilization Technologies 9120 South 150 East Sandy, UT 84070 Isomedix Operations, Inc.
dba STERIS Applied Sterilization Technologies 1435 Isomedix Place El Paso, TX 79936 Isomedix Operations, Inc.
dba STERIS Applied Sterilization Technologies 1000 S. Sarah Place Ontario, CA 91761 15.
Bausch & Lomb 8507 Pelham Road Greenville, SC 29615 BD Life Sciences 1575 Airport Road Sumter, SC 29153 Becton, Dickinson, and Company 1852 10th Avenue Columbus, NE 68601 Corning Incorporated One Becton Circle Durham, NC 27712 GE-Hitachi Nuclear Energy Americas, LLC Vallecitos Nuclear Center 6705 Vallecitos Road Sunol, CA 94586 Isomedix Operations, Inc.
dba STERIS Applied Sterilization Technologies 4405 Marketing Place Groveport, OH 43125 Isomedix Operations, Inc.
dba STERIS Applied Sterilization Technologies 2072 Southport Road Spartanburg, SC 29306 Isomedix Operations, Inc.
dba STERIS Applied Sterilization Technologies 435 Whitney Street Northborough, MA 01532 16.
PXB3.15 Page 3 of 5 OTHER U.S. PARTY(IES) TO EXPORT Continued:
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Isomedix Operations, Inc.
dba STERIS lsomedix Services 1880 Industrial Drive Libertyville, IL 60048 KPR U.S., LLC 1222 Sherwood Road Norfolk, NE 68701 lsomedix Operations, Inc.
dba STERIS Applied Sterilization Technologies 23 Elizabeth Drive Chester, NY 10918 Pall Hauppauge 225 Marcus Blvd.
Hauppauge, NY 11788 Sterigenics U.S., LLC 1148 Porter Avenue Haw River, NC 27258 Sterigenics U.S., LLC 75 Tilbury Road Salem, NJ 08079 Sterigenics U.S., LLC 344 Bonnie Circle Corona, CA 92878 30.
Isomedix Operations, Inc.
dba STERIS lsomedix Services 2500 Commerce Drive Libertyville, IL 60048 KPR U.S., LLC 2010 East International Speedway Blvd.
DeLand, FL 32724 lsomedix Operations, Inc.
dba STERIS Applied Sterilization Technologies 9 Apollo Drive Whippany, NJ 07981 Nypro Healthcare Baja, Inc.
3801 University Blvd, SE Albuquerque, NM 87106 Sandia National Laboratories Operated for the U.S. Department of Energy by Sandia Corporation Albuquerque, NM 87185 Sterigenics U.S., LLC 108 Lake Denmark Road Rockaway, NJ 07866 Sterigenics U.S., LLC 1700 College Boulevard West Memphis, AR 72301 Sterigenics U.S., LLC 5900 Obata Way Gilroy, CA 95020 31.
Sterigenics U.S., LLC 2311 Lincoln Avenue Hayward, CA 94545 32.
Sterigenics U.S., LLC 502 Prairie Mine Road Mulberry, FL 33860 33.
Sterigenics U.S., LLC 10811 Withers Cove Park Drive Charlotte, NC 28278 34.
Sterigenics U.S., LLC 305 Enterprise Drive Lewis Center, OH 43081 35.
Sterigenics U.S., LLC 1401 Morgan Circle Tustin, CA 92780 36.
Sterigenics U.S., LLC (Location 1) 3001 Wichita Court Fort Worth, TX 76140 37.
Sterigenics U.S., LLC (Location 1) 711 East Cooper Court Schaumburg, IL 60173 38.
Sterigenics U.S., LLC (Location 2) 1003 Lakeside Dr.
Gurnee, IL 60031 39.
Sterigenics U.S., LLC (Location 2) 3125 Wichita Court Fort Worth, TX 76140 40.
PXB3.15 Page 4 of 5 OTHER U.S. PARTY(IES) TO EXPORT Continued:
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Terumo Medical Corporation 950 Elkton Boulevard Elkton, MD 21921 University of Maryland Medical Systems, Gamma Knife Suite South Hospital B Wing 22 South Greene Street Baltimore, MD 21201 University of Texas Southwestern Medical Center at Dallas 2280 Inwood Road Dallas, TX 75235 46.
Steris Isomedix Puerto Rico LLC dba STERIS Applied Sterilization Technologies State Road 690, Km 1.7 Vega Alta, PR 00692 Uniformed Services University of the Health Sciences Armed Forces Radiobiology Research Institute 8901 Wisconsin Avenue Bethesda, MD 20889 University of Massachusetts Lowell One University Ave Lowell, MA 01854 University of Wisconsin-Madison Wisconsin Institutes for Medical Research 1111 Highland Avenue Madison, WI 53705 47.
PXB3.15 Page 5 of 5 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.