U.S. Departmentof TransportationPipeline andHazardous MaterialsSafety Administration

East Building, PHH-23

1200 New Jersey Avenue SoutheastWashington, D.C. 20590

COMPETENT AUTHORITY CERTIFICATION

FOR A TYPE B(U) RADIOACTIVE MATERIALS PACKAGE DESIGN

CERTIFICATE USA/0562/B(U)-96, REVISION 8

REVALIDATION OF SOUTH AFRICAN COMPETENT AUTHORITYCERTIFICATE ZA/NNR 1005/B(U)-96

This certifies that the radioactive material package design described ishereby approved for use within the United States for import and exportshipments only. Shipments must be made in accordance with the applicableregulations of the International Atomic Energy Agency¹ and the United Statesof America².

¹ "Regulations for the Safe Transport of Radioactive Material, 1996Edition (Revised), No. TS-R-1 (ST-1, Revised)," published by theInternational Atomic Energy Agency(IAEA), Vienna, Austria.

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

1. Package Identification - ZA/NNR/1005/B(U)-96 (Beatrice).

2. Package Description and Authorized Radioactive Contents - as describedin South Africa Certificate of Competent Authority ZA/NNR1005/B(U)-96, Revison 2 (attached).

3. General Conditions -

a. Each user of this certificate must have in his possession a copyof this certificate and all documents necessary to properlyprepare the package for transportation. The user shall preparethe package for shipment in accordance with the documentationand applicable regulations.

b. Each user of this certificate, other than the originalpetitioner, shall register his identity in writing to the Officeof Hazardous Materials Technology, (PHH-23), Pipeline andHazardous Materials Safety Administration, U.S. Department ofTransportation, Washington D.C. 20590-0001.

c. This certificate does not relieve any consignor or carrier fromcompliance with any requirement of the Government of any countrythrough or into which the package is to be transported.

(- 2 -)

CERTIFICATE USA/0562/B(U)-96, REVISION 8

d. Records of Quality Assurance activities required by Paragraph310 of the IAEA regulations¹ shall be maintained and madeavailable to the authorized officials for at least three yearsafter the last shipment authorized by this certificate.Consignors in the United States exporting shipments under thiscertificate shall satisfy the applicable requirements of SubpartH of 10 CFR 71.

4. Special Conditions -

a. Prior to each shipment, the inner cavity liner, including thecavity liner welds, must be visually inspected to assure thatthere is no visible evidence of cracks, pinholes or otherdefects.

b. In accordance with the attached South African certificate, thiscertificate cannot be used until January 2, 2013.

5. Marking and Labeling - The package shall bear the markingUSA/0562/B(U)-96 in addition to other required markings and labeling.

6. Expiration Date - This certificate expires on January 02, 2018. OnJanuary 02, 2013, this certificate supersedes all previous revisionsof USA/0562/B(U)-96.

This certificate is issued in accordance with paragraph 808 of the IAEARegulations and Section 173.473 of Title 49 of the Code of FederalRegulations, in response to the August 27, 2012 petition by NTPRadioisotopes, Pretoria, South Africa, South Africa, and in consideration ofother information on file in this Office.

Certified By:

Oct 25 2012Dr. Magdy El-SibaieAssociate Administrator for Hazardous Materials Safety

(DATE)

Revision 8 - issued to revalidate South Africa Certificate of CompetentAuthority ZA/NNR/1005/B(U)-96 Revision 02, dated August 23,2012.

U.S. Departmentof Transportation

East Building, PHH-231200 New Jersey Avenue SE

Washington, D.C. 20590

Pipeline andHazardous MaterialsSafety Administration

CERTIFICATE NUMBER: USA/0562/B(U)-96, Revision 8

ORIGINAL REGISTRANT(S):

Mr. H.G. WortmannManager: Quality, Regulatory and SafetyNTP RadioisotopesP.O. Box 582Pretoria 0001, South Africa South Africa

REGISTERED USER(S):

Ms. April ChanceManager, Radiological AffairsMallinckrodt Inc.675 McDonnell BlvdHazelwood, 63042USA

Mr. Bernard DavidProduction & Supply Chain ManagerIREAvenue de l'Esperance, 1B-6220Fleurus, Belgium

Mr. Julien ThonnartRegulatory AffairsIREAvenue de l'Esperance, 1B-6220Fleurus, Belgium

Mr. Marc BleusConventional and Nuclear Safety ManagerIREAvenue de l'Esperance 1B-6220Fleurus, Belgium

Mr. David AchiolasRadiochemical Production SupervisorIREAvenue de l'Esperance 1B-6220Fleurus, Belgium

Ms. Geraldine MainilTechnical Administrative AssistantIREAvenue de L'Esperance 1B-6220Fleurus, Belgium

Henk DoornebosManager DistributionMallinckrodt Medical BVWesterduinweg 3PO Box 31755 ZGPetten, The Netherlands

Mr. Arvid TesselaarManager, International Transport and ComplianceMallinckrodt Medical BVWesterduinweg 3P.O. Box 31755 ZG Petten, The Netherlands 1755The Netherlands

Mike KilfoilSenior Reactor Project ManagerUniversity of Missouri-ColumbiaResearch Reactor CenterUniversity of Missouri-ColumbiaResearch ParkColumbia, 65211USA

Amber GaddyCompliance SpecialistUniversity of Missouri-Columbia1513 Research ParkColumbia, 65211USA

John ErnstAssoc. Director, Regulatory AssuranceUniversity of Missouri-ColumbiaResearch Reactor1513 Research ParkColumbia, 65211USA

Mr. Lee JuengermannManager, RAM ShippingUniversity of Missouri-Columbia1513 Reasearch Park DriveColumbia, 65211USA