ML24038A345

Export License Issued Nordion (Canada) Inc. PXB3.15

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

EXPORT LICENSE NRC FORM 250 NRC LICENSE NO.: PXB3.15 United States of America Page 1 of 5 Nuclear Regulatory Commission NRC DOCKET NO.: 11006070 W ashington, D.C. 20555 LICENSE EXPIRES: July 31, 2030

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 U LTIM ATE CONSIGNEE(S) IN FOREIGN COUNTRY(IES)

Nordion (Canada) Inc. Nordion (Canada), Inc.

447 March Road 447 March Road Ottawa, Ontario, K2K 1X8 Ottawa, Ontario, K2K 1X8 Canada Canada

Attn: Luc Desgagne (supplier)

INTERMEDI ATE CONSIGNEE(S) IN FOREIGN COUNTRY(IES) OTHER U.S. PARTY(IES) TO EXPORT None See following page(s)

APPLICANT'S

REFERENCE:

PXB3.14 AMEND1-2023 U LTIMATE DESTIN ATION: Canada

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.

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 B Y AUTHORIZED NRC REPRESEN TATIVE Energy Act of 1954, as amended.

This license is subject to the right of recapture or control by Section 108 NAME AND TITLE:

of the Atomic Energy Act of 1954, as amended, and to all the other Sabrina D. Atack, Deputy Director 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. D ATE OF ISSUANCE: February 7, 2024

EXPORT LICENSE PXB3.15 Page 2 of 5

CONDITIONS

[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.

[2] 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;

[3] 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.

OTHER U.S. P ARTY(IES) TO EXPORT Continued :

1. 2.3M CompanyBausch & Lomb 601 22nd Avenue South 8507 Pelham Road Brookings, SD 57006 Greenville, SC 29615

3. 4.Baxter Healthcare of Puerto RicoBD Life Sciences State Road 721, Km 0.3 1575 Airport Road Aibonito, PR 00705 Sumter, SC 29153

5. 6.Becton Dickinson InfusioBecton, Dickinson, and Company Therapy Systems, Inc. 1852 10th Avenue 150 South 1st Avenue Columbus, NE 68601 Broken Bow, NE 68822

7. 8.Becton, Dickinson, and CompanyCorning Incorporated dba BD Medical Systems - Diabetes Care One Becton Circle 1329 West Highway 6 Durham, NC 27712 Holdrege, NE 68949

9. 10.Department of the Army CommanderGE-Hitachi Nuclear Energy Americas, LLC White Sands Missile Range V allecitos Nuclear Center NM 88002 6705 V allecitos Road Sunol, CA 94586

11. 12.Isomedix Operations, Inc.Isomedix Operations, Inc.

dba STERIS Applied Sterilization Technologies dba STERIS Applied Sterilization Technologies 9120 South 150 East 4405 Marketing Place Sandy, UT 84070 Groveport, OH 43125

13. 14.Isomedix Operations, Inc.Isomedix Operations, Inc.

dba STERIS Applied Sterilization Technologies dba STERIS Applied Sterilization Technologies 1435 Isomedix Place 2072 Southport Road El Paso, TX 79936 Spartanburg, SC 29306

15. Isomedix Operations, Inc. 16. Isomedix Operations, Inc.

dba STERIS Applied Sterilization Technologies dba STERIS Applied Sterilization Technologies 1000 S. Sarah Place 435 Whitney Street Ontario, CA 91761 Northborough, MA 01532 PXB3.15 Page 3 of 5 OTHER U.S. P ARTY(IES) TO EXPORT Continued :

17. 18.Isomedix Operations, Inc.Isomedix Operations, Inc.

dba STERIS lsomedix Services dba STERIS lsomedix Services 2500 Commerce Drive 1880 Industrial Drive Libertyville, IL 60048 Libertyville, IL 60048

19. KPR U.S., LLC 20. KPR U.S., LLC 2010 East International Speedway Blvd. 1222 Sherwood Road DeLand, FL 32724 Norfolk, NE 68701

21. 22.lsomedix Operations, Inc.lsomedix Operations, Inc.

dba STERIS Applied Sterilization Technologies dba STERIS Applied Sterilization Technologies 9 Apollo Drive 23 Elizabeth Drive Whippany, NJ 07981 Chester, NY 10918

23. 24.Nypro Healthcare Baja, Inc.Pall Hauppauge 3801 University Blvd, SE 225 Marcus Blvd.

Albuquerque, NM 87106 Hauppauge, NY 11788

25. 26.Sandia National LaboratoriesSterigenics U.S., LLC Operated for the U.S. Department of Energy 1148 Porter Avenue by Sandia Corporation Haw River, NC 27258 Albuquerque, NM 87185

27. 28.Sterigenics U.S., LLCSterigenics U.S., LLC 108 Lake Denmark Road 75 Tilbury Road Rockaway, NJ 07866 Salem, NJ 08079

29. Sterigenics U.S., LLC 30. Sterigenics U.S., LLC 1700 College Boulevard 344 Bonnie Circle West Memphis, AR 72301 Corona, CA 92878

31. Sterigenics U.S., LLC 5900 Obata Way 32. Sterigenics U.S., LLC Gilroy, CA 95020 2311 Lincoln Avenue Hayward, CA 94545

33. Sterigenics U.S., LLCSterigenics U.S., LLC34.

502 Prairie Mine Road 108 11 Withers Cove Park Drive Mulberry, F L 33860 Charlotte, NC 28278

35. Sterigenics U.S., LLCSterigenics U.S., LLC36.

305 Enterprise Drive 1401 Morgan Circle Lewis Center, OH 43081 Tustin, CA 92780

37. Sterigenics U.S., LLC (Location 1)Sterigenics U.S., LLC (Location 1)38.

3001 Wichita Court 711 East Cooper Court Fort Worth, TX 76140 Schaumburg, IL 60173

39. Sterigenics U.S., LLC (Location 2)Sterigenics U.S., LLC (Location 2)40.

1003 Lakeside Dr. 3125 Wichita Court Gurnee, I L 60031 Fort Worth, TX 76140 PXB3.15 Page 4 of 5 OTHER U.S. P ARTY(IES) TO EXPORT Continued:

41. 42.Steris Isomedix Puerto Rico LLCTerumo Medical Corporation dba STERIS Applied Sterilization Technologies 950 Elkton Boulevard State Road 690, Km 1.7 Elkton, MD 21921 Vega Alta, PR 00692

44. University of Maryland Medical Systems,

43. Uniformed Services University of the Health Sciences Gamma Knife Suite Armed Forces Radiobiology Research Institute South Hospital B Wing 8901 Wisconsin Avenue 22 South Greene Street Bethesda, MD 20889 Baltimore, MD 21201

University of Massachusetts Lowell 46. University of Texas Southwestern

45. Medical Center at Dallas One University Ave 2280 Inwood Road Lowell, MA 01854 Dallas, TX 75235

47. University of Wisconsin-Madison Wisconsin Institutes for Medical Research 1111 Highland Avenue Madison, WI 53705 PXB3.15 Page 5 of 5 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 -238 2 (Pu -238) 60 1,600 0.6 16 Plutonium -239/Beryllium 2 (Pu-239/Be) 60 1,600 0.6 16 Promethium -147 (Pm -147) 40,000 1,100,000 400 11,000 Radium -226 3 (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 R 2 R n A R 2 AR n 1 1 A R 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.