ML21138A943

Advanced Reactors GEIS Docs - Certification for Type B Radioactive Materials Package Design

ML21138A943
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Issue date:	05/18/2021
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U.S. Department of Transportation COMPETENT AUTHORITY CERTIFICATION FOR A TYPE B(U)

RADIOACTIVE MATERIALS PACKAGE DESIGN East Building, PHH-23 1200 New Jersey Ave, SE Washington, D.C. 20590 Pipeline and Hazardous Materials Safety Administration CERTIFICATE USA/0596/B(U)-96, REVISION 6 REVALIDATION OF UNITED KINGDOM COMPETENT AUTHORITY CERTIFICATE GB/3605D/B(U)-96 The Competent Authority of the United States certifies that the radioactive material package design described in this certificate satisfies the regulatory requirements for a Type B(U) package as prescribed in the regulations of the International Atomic Energy Agency1 and the United States of America2.

1. Package Identification - U. K. Design No. 3605D.

2. Package Description and Authorized Radioactive Contents - as described in United Kingdom Certificate of Competent Authority GB/3605D/B(U)-96, Revision 7 (attached).

3. General Conditions -

a. Each user of this certificate must have in his possession a copy of this certificate and all documents necessary to properly prepare the package for transportation. The user shall prepare the package for shipment in accordance with the documentation and applicable regulations.

b. Each user of this certificate, other than the original petitioner, shall register his identity in writing to the Office of Engineering and Research, (PHH-23), Pipeline and Hazardous Materials Safety Administration, U.S.

Department of Transportation, Washington D.C. 20590-0001.

c. This certificate does not relieve any consignor or carrier from compliance with any requirement of the Government of any country through or into which the package is to be transported.

1 "Regulations for the Safe Transport of Radioactive Material, 2012 Edition, No. SSR-6" published by the International Atomic Energy Agency (IAEA),

Vienna, Austria.

2 Title 49, Code of Federal Regulations, Parts 100-199, United States of America.

(- 2 -)

CERTIFICATE USA/0596/B(U)-96, REVISION 6

d. Records of Management System activities required by Paragraph 306 of the IAEA regulations1 shall be maintained and made available to the authorized officials for at least three years after the last shipment authorized by this certificate. Consignors in the United States exporting shipments under this certificate shall satisfy the applicable requirements of Subpart H of 10 CFR 71.

4. Marking and Labeling - The package shall bear the marking USA/0596/B(U)-96 in addition to other required markings and labeling.

5. Expiration Date - This certificate expires on December 31, 2022.

This certificate is issued in accordance with paragraph(s) 810 of the IAEA Regulations and Section 173.473 of Title 49 of the Code of Federal Regulations, in response to the February 6, 2018 petition by GE Healthcare, Arlington Heights, IL, and in consideration of other information on file in this Office.

Certified By:

March 21, 2018 William Schoonover Associate Administrator for Hazardous Materials Safety (DATE)

Revision 6 - Issued to revalidate U. K. Certificate of Approval of Package Design GB/3605D/B(U)-96, Rev. 7.

GB/3605D/B(U)-96 (Rev.7)

Page 1 of 6 Office for Nuclear Regulation TRIM

Reference:

2017/380772 CERTIFICATE OF APPROVAL OF PACKAGE DESIGN FOR THE CARRIAGE OF RADIOACTIVE MATERIAL This is to certify that for the purposes of the Regulations of the International Atomic Energy Agency The Competent Authority of Great Britain in respect of inland surface transport, being the Office for Nuclear Regulation; The Competent Authority of the United Kingdom of Great Britain and Northern Ireland in respect of sea transport, being the Secretary of State for Transport; The Competent Authority of the United Kingdom of Great Britain and Northern Ireland in respect of air transport, being the Civil Aviation Authority; and The Competent Authority of Northern Ireland in respect of road transport, being the Department of Agriculture, Environment and Rural Affairs - Northern Ireland approve the package design specified in Section 1 of this certificate, as submitted for approval by GE Healthcare (see Section 5) as: Type B(U) by: road, rail, sea and air.

Packaging identification: 3605D Packages manufactured to this design meet the requirements of the regulations and codes on page 2, relevant to the mode of transport, subject to the following general condition and to the conditions in the succeeding pages of this certificate.

In the event of any alteration in the composition of the package, the package design, the management system(s) associated with the package or in any of the facts stated in the application for approval, this certificate will cease to have effect unless the Competent Authority is notified of the alteration and the Competent Authority confirms the certificate notwithstanding the alteration.

Expiry Date: This certificate cancels all previous revisions and is valid until the end of 31 December 2022 (see Section 5).

COMPETENT AUTHORITY IDENTIFICATION MARK: GB/3605D/B(U)-96 Signature:

Date of Issue: 22 December 2017 David Ian Barlow, Superintending Inspector Head of GB Competent Authority, Land Transport of Radioactive Material Office for Nuclear Regulation Redgrave Court, Merton Road Bootle, Merseyside L20 7HS on behalf of the Office for Nuclear Regulation; and the Secretary of State for Transport; the Civil Aviation Authority; and the Department of Agriculture, Environment and Rural Affairs - Northern Ireland.

This certificate does not relieve the consignor from compliance with any requirement of the government of any country through or into which the package will be transported.

GB/3605D/B(U)-96 (Rev.7)

Page 2 of 6 Office for Nuclear Regulation TRIM

Reference:

2017/380772 REGULATIONS GOVERNING THE TRANSPORT OF RADIOACTIVE MATERIALS INTERNATIONAL International Atomic Energy Agency (IAEA)

SSR-6 Regulations for the Safe Transport of Radioactive Material 2012 Edition United Nations Economic Commission for Europe (UNECE)

European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) 2017 Edition Intergovernmental Organisation for International Carriage by Rail (OTIF)

Regulations concerning the International Carriage of Dangerous Goods by Rail (RID) 2017 Edition International Maritime Organization (IMO)

International Maritime Dangerous Goods (IMDG) Code 2014 Edition incorporating Amendment 37-14 (until end of December 2017) or International Maritime Dangerous Goods (IMDG) Code 2016 Edition incorporating Amendment 38-16 International Civil Aviation Organization (ICAO)

Technical Instructions for the Safe Transport of Dangerous Goods by Air 2017-2018 Edition UNITED KINGDOM ROAD GREAT BRITAIN ONLY:

The Energy Act 2013 (2013 c. 32); The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009 (SI 2009 No. 1348); The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment (Amendment) Regulations 2011 (SI 2011 No. 1885); The Energy Act 2013 (Office for Nuclear Regulation) (Consequential Amendments, Transitional Provisions and Savings)

Order 2014 (SI 2014 No. 469)

NORTHERN IRELAND ONLY:

The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations (Northern Ireland) 2010, SR 2010 No 160; The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment (Amendment) Regulations (Northern Ireland) 2011, No 365 RAIL GREAT BRITAIN ONLY:

The Energy Act 2013 (2013 c. 32); The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009 (SI 2009 No. 1348); The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment (Amendment) Regulations 2011 (SI 2011 No. 1885); The Energy Act 2013 (Office for Nuclear Regulation) (Consequential Amendments, Transitional Provisions and Savings)

Order 2014 (SI 2014 No. 469)

SEA British registered ships and all other ships whilst in United Kingdom territorial waters:

The Merchant Shipping Act 1995 (1995 c. 21); The Merchant Shipping (Dangerous Goods and Marine Pollutants) Regulations 1997 (SI 1997 No. 2367); Merchant Shipping Notice MSN 1875 (M) The Carriage of Dangerous Goods and Marine Pollutants in Packaged Form: Amendment 38-16 to the International Maritime Dangerous Goods (IMDG) Code AIR The Air Navigation Order 2016 (SI 2016 No. 765); The Air Navigation (Dangerous Goods) Regulations 2002 (SI 2002 No.2786); The Air Navigation (Dangerous Goods) (Amendment) Regulations 2017 (SI 2017 No.28)

GB/3605D/B(U)-96 (Rev.7)

Page 3 of 6 Office for Nuclear Regulation TRIM

Reference:

2017/380772

1.

DESIGN SPECIFICATION Package Design 1.1 The package design specification shall be in accordance with GE Healthcare Ltd Type B Design Safety Report Index Package Design Number 3605D, TAD3605D, Issue 15, dated 20 October 2017, and modifications to the package design approved by the authorities named on page 1 of this certificate under the established modifications procedure.

Design Drawings 1.2 The design is specified in the following drawings.

Design No.

Title (number of components)

Drawing / Drawing List Issue 3605 Outer Steel Drum with Cork Spacers (One)

DL 25180 and PGM 865 J

7 3055 Intermediate Containment Pot (One)

DL22310 O

0035 (Mk3)

Inner Stainless Steel Pots Tritium Bed (One)

DL23205 F

0035 (Mk4)

DL23549 G

0035 (Mk5)

DL27816 B

Package Description and Materials of Manufacture 1.3 Package design number 3605D comprises a zinc or nickel coated steel drum with a stainless steel clamp band and cork insulation and packing. The 3055 inner stainless steel pot acts as the containment system for a 0035 stainless steel pot which is a vessel for containing tritium as solid uranium tritide. See Appendix 1 for package illustration.

Package Dimension and Weights 1.4 Nominal Dimensions: 325mm diameter x 405mm high (see section 5 for package illustration).

1.5 Maximum authorised gross weight: 20.7 kg.

Authorised Contents 1.6 The authorised radioactive contents are:

a) Tritium gas adsorbed on pyrophoric uranium in a stainless steel vessel.

b) The maximum activities of the authorised contents are 4 PBq of tritium and 6 MBq of depleted uranium.

c) The maximum heat loads of the authorised contents are 3.65 W of tritium and 4 W of depleted uranium.

Containment System 1.7 The containment system is defined by the 3055 Intermediate Containment Pot provided with its containment seal and the closure system consisting of 6 M4 stainless steel bolts.

2.

USE OF PACKAGE Information Provided in Safety Report on Use of Packaging 2.1 The packaging shall be used, handled and maintained in accordance with the requirements of MGC_UKD_PQ_146 Version 4 dated 18 October 2017.

GB/3605D/B(U)-96 (Rev.7)

Page 4 of 6 Office for Nuclear Regulation TRIM

Reference:

2017/380772 Actions Prior to Shipment 2.2 Administrative controls shall ensure that the contents are in accordance with section 1 of this certificate, and that the consignor and consignee hold a copy of the instructions on the use of the packaging.

2.3 The package is not required to reach thermal equilibrium prior to shipment.

Emergency Arrangements 2.4 Before shipment takes place, suitable emergency plans will have been drawn up, copies of which shall be supplied to the GB Competent Authority on demand.

2.5 Within Great Britain, if the consignors own, or other approved emergency plans, cannot be initiated for any reason, then the police shall be informed immediately and requested to call NAIR (National Arrangements for Incidents involving Radioactivity).

3.

MANAGEMENT SYSTEMS 3.1 The management system(s) assessed as adequate in relation to this design by the authorities named on page 1 of this certificate, at the date of issue, are as specified in GE Healthcare Ltd Type B Design Safety Report Index Package Design Number 3605D, TAD3605D, Issue 15, dated 20 October 2017 referred to in Section 1 above, and comprise the following:

GE Healthcare Global Quality Management System, GEHC_GQM Revision 11 (DOC0041547);

and any other quality assurance programmes for design; testing; manufacture; documentation; use; maintenance and inspection; and transport and in transit storage operations, providing they comply with national or international standards for quality assurance agreed as acceptable by the authorities named on page 1 of this certificate.

3.2 No alteration may be made to any management system confirmed as adequate in relation to this design, unless:

a) the authorities named on page 1 of this certificate have confirmed the amended management system is adequate prior to implementation or use; or b) the alteration falls within the agreed change control procedures set out in the management system(s).

3.3 Other management systems for design, testing, manufacture, documentation, use, maintenance, inspection, transport and in-transit storage operations may be used providing they comply with international, national or other standards for management systems agreed as acceptable by the authorities named on page 1 of this certificate.

4.

ADMINISTRATIVE INFORMATION Packaging Serial Numbers 4.1 For the purpose of compliance with ADR / RID, the owner of the packaging shall be responsible for informing ONR of the serial number of each packaging manufactured to this design.

Additional Technical Data / Information 4.2 At the time of compilation of this design approval certificate, The Ionising Radiations Regulations 1999, SI 1999 No 3232 and Approved Code of Practice apply, with regard to radiation protection, to all modes of transport and The Dangerous Substances in Harbour Areas Regulations 2016, SI 2016 No 721, apply in GB Ports, and The Dangerous Substances in Harbour Areas Regulations (Northern Ireland) 1991 SI 1991 No 509 apply in NI Ports.

GB/3605D/B(U)-96 (Rev.7)

Page 5 of 6 Office for Nuclear Regulation TRIM

Reference:

2017/380772

5.

CERTIFICATE STATUS Design approval issued to:

GE Healthcare Ltd The Grove Centre White Lion Road Amersham Buckinghamshire HP7 9LL Issue /

Revision Number Date of Issue Date of Expiry Reason for Revision 1

25 September 2005 30 September 2006 First issued under new regulations 2

25 September 2005 30 September 2006 Extended by letter to 31 April 2007 Minor typographical changes.

3 23 March 2007 31 March 2012 Renewal on expiry of an extension to the previous certificate.

4 18 April 2007 31 March 2012 Issued to correct an error in section 2.1 a) of the issue 3 certificate.

5 28 March 2012 31 March 2017 5-yearly renewal 6

31 March 2017 30 September 2017 6 months extension 7

22 December 2017 31 December 2022 5-yearly renewal

GB/3605D/B(U)-96 (Rev.7)

Page 6 of 6 Office for Nuclear Regulation TRIM

Reference:

2017/380772 APPENDIX 1 - PACKAGE ILLUSTRATION

1 U.S. Department of Transportation East Building, PHH-23 1200 New Jersey Ave, SE Washington, D.C. 20590 Pipeline and Hazardous Materials Safety Administration CERTIFICATE NUMBER: USA/0596/B(U)-96 ORIGINAL REGISTRANT(S):

GE Healthcare 3350 N. Ridge Avenue Arlington Heights, IL, 60004 USA Moravek, Inc.

2770 Salk Avenue Richland, WA, 99352 USA American Radiolabeled Chemicals, Inc.

101 ARC Dr.

St. Louis, MO, 63146 USA ViTrax Company ViTrax Company 660 S. Jefferson St.

1. E Placentia, CA, 92870 USA University of Rochester Laboratory for Laser Energetics 250 East River Road Rochester, NY, 14623-1299 USA Schlumberger 300 Schlumberger Drive MD-121 Sugar Land, TX, 77478 USA Canadian Nuclear Laboratories 286 Plant Road

2 Chalk River, Ontario, K0J 1J0 Canada PerkinElmer Life and Analytical Sciences 549 Albany Street Boston, MA, 02118 USA