ML23088A400

Export License Issued to Nordion (Canada) Inc. PXB3.14

ML23088A400
Person / Time
Site:	11006070
Issue date:	03/29/2023
From:	Sabrina Atack NRC/OIP
To:	Desgagne L Nordion (Canada)
References
Download: ML23088A400 (1)

Text

EXPORT LICENSE NRC FORM 250 (10-07) NRC LICENSE NO.: PXB3.14 United States of America Page 1 of 5 Nuclear Regulatory Commission NRC DOCKET NO.: 11006070 Washington, 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 ULTIMATE CONSIGNEE(S) IN FOREIGN COUNTRY(IES)

Nordion (Canada), Inc.

Nordion (Canada) Inc.

447 March Road 447 March Road Ottawa, Ontario Ottawa, Ontario, Canada K2K 1 X8 Canada K2K 1X8 Attn: Luc Desgagne INTERMEDIATE CONSIGNEE(S) IN FOREIGN COUNTRY(IES) OTHER U.S. PARTY(IES) TO EXPORT None See following page(s)

APPLICANT'S

REFERENCE:

PXB3.13 Amend1-2023 ULTIMATE DESTINATION: Canada CONDITIONS, NOTES, AND DESCRIPTIONS OF 10CFR PART 110, APPENDIX P, BYPRODUCT AND SOURCE MATERIALS TO BE EXPORTED (NOTE: SEE PAGE 2 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 2.

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 is exempt from the requirement in 10 CFR 110.53(a) to maintain an office within the United States.

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 3 for Mandatory Advanced Notifications License expiration date is based on established limits. This license replaces PXB3.13 and amends its authority by adding "Other U.S. Party(ies) to Export" number 44 and number 46.

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 EnergyAct of 1954, as amended.

Sabrina D. Atack Digitally signed by Sabrina D. Atack Date: 2023.03.29 07:26:10 -04'00' This license is subject to the right of recapture or control by Section 108 NAME AND TITLE:

Sabrina D. Atack, Deputy Director of the Atomic Energy Act of 1954, as amended, and to all the other Office of International Programs provisions of said Acts, now or hereafter in effect and to all valid rules and regulations of the Nuclear Regulatory Commission.

DATE OF ISSUANCE: March 29, 2023 EXPORT LICENSE

PXB3.14 Page 2 of 5 CONDITIONS, NOTES, AND DESCRIPTIONS OF 10CFR PART 110, APPENDIX P, BYPRODUCT AND SOURCE MATERIALS TO BE EXPORTED(cont'd)

[1] 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 yet been requested, received and processed until the following actions are taken:

The licensee submits 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 importing country's regulatory authority; The NRC receives and considers the consent from the importing country's regulatory authority pursuant to 10CFR 110.42(e)(3); and The NRC has informed the licensee in writing, that the consent request has been granted and it is authorized to ship the materials to the ultimate consignee(s) specified on the NRC Form 7 consent request.

OTHER U.S.PARTY(IES) TO EXPORT Continued:

1. 3M Company 2. Bausch & Lomb 601 22nd Avenue South 8507 Pelham Road Brooklngs, SD 57006 Greenville, SC 29615

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

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

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

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

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

dba Steris Applied Sterilization Technologies dba STERIS Isomedix Services 1000 S. Sarah Place 1880 Industrial Drive Ontario, CA 91761 Libertyville, IL 60048

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

dba STERIS Isomedix Services dba Steris Applied Sterilization Technologies 2500 Commerce Drive 435 Whitney Street Libertyville, IL 60048 Northborough, MA 01523

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

dba STERIS Applied Sterilization dba STERIS Applied Sterilization Technologies Technologies 4405 Marketing Place 1435 Isomedix Place Groveport, OH 43125 El Paso, TX 79936

PXB3.14 Page 3 of 5 OTHER U.S.PARTY(IES) TO EXPORT Continued:

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

dba STERIS Applied Sterilization dba Steris Applied Sterilization Technologies Technologies 2072 Southport Road 9120 South 150 East Spartanburg, SC 29306 Sandy, UT 84070

19. KPR U.S., L.L.C. 20. KPR U.S., LLC.

2010 East International Speedway Blvd. 1222 Sherwood Road DeLand, FL 32724 Norfolk, NE 68701

21. lsomedix Operations, Inc. 22. 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. Nypro Healthcare Baja, Inc. 24. Pall Hauppauge 3801 University Blvd, SE 225 Marcus Blvd.

Albuquerque,, NM 87106 Hauppauge, NY 11788

25. Sandia National Laboratories 26. Sterigenics U.S., LLC Operated for the U.S. Department of Energy 1401 Morgan Circle by Sandia Corporation Tustin, CA 92780 Albuquerque, NM 87185

27. Sterigenics US, LLC 28. Sterigenics US., LLC 2311 Lincoln Avenue 10811 Withers Cove Park Drive Hayward, CA 94545 Charlotte, NC 28278

29. Sterigenics US., LLC 30. Sterigenics US., LLC 305 Enterprise Drive 1148 Porter Avenue Lewis Center, OH 43081 Haw River, NC 27258

31. Sterigenics US., LLC 32. Sterigenics US., LLC 108 Lake Denmark Road 75 Tilbury Road Rockaway, NJ 07866 Salem, NJ 08079

33. Sterigenics US., LLC 34. Sterigenics US., LLC 1700 College Boulevard 344 Bonnie Circle West Memphis, AZ 72301 Corona, CA 92880

35. Sterigenics US., LLC 36. Sterigenics US., LLC (Location 1) 5900 Obata Way 3001 Wichita Court Gilroy, CA 95020 Fort Worth, TX 76140

37. Sterigenics US., LLC (Location 1) 38. Sterigenics US., LLC (Location 2) 711 East Cooper Court 1003 Lakeside Dr.

Schaumburg, IL 60173 Gurnee, IL 60031

39. Sterigenics US., LLC (Location 2) 40. Sterigenics US., LLC.

3125 Wichita Court 502 Prairie Mine Road Fort Worth, TX 76140 Mulberry, FL 33860

PXB3.14 Page 4 of 5 OTHER U.S.PARTY(IES) TO EXPORT Continued:

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

43. Uniformed Services University of the Health 44. University of Maryland Medical Systems, Sciences Gamma Knife Suite Armed Forces Radiobiology Research South Hospital B Wing, Institute 22 South Greene Street, 8901 Wisconsin Avenue Baltimore, MD 21201 Bethesda, MD 20889

45. University of Massachusetts Lowell 46. University of Texas Southwestern Medical One University Ave Center at Dallas Lowell, MA 01854 2280 Inwood Road, Dallas, TX 75235

PXB3.14 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-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.