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No. 97-091 June 12, 1997
OF FABRICATION OF PACKAGES FOR TRANSPORTATION OF RADIOACTIVE MATERIAL
The Nuclear Regulatory Commission has issued a Confirmatory Action Letter to Amersham Corporation, holder of several NRC certificates of compliance for packages used to transport radioactive materials. The letter confirms that Amersham will immediately suspend fabrication of all NRC-certified transportation packages and take certain other actions.
During a June 4-6 inspection at Amersham's facility in Burlington, Massachusetts, the NRC identified problems regarding Amersham's performance of tests required under NRC regulations. The tests are designed to show ability of the packages to withstand hypothetical accident conditions and include a free-drop test of 30 feet onto a flat, essentially unyielding, horizontal surface, striking the surface in a position for which maximum damage is expected. A package must also withstand a puncture test where it is dropped 40 inches, in a position for which maximum damage is expected, onto the end of a vertical steel bar mounted on an essentially unyielding, horizontal surface. Concerns identified during the inspection included: whether the steel puncture bar was properly mounted on the test pad, whether the condition of the test pad used for the tests constituted an essentially unyielding surface, whether the free-drop tests and the puncture tests were performed in the most damaging position, and whether the test conditions and results were accurately and fully recorded, assessed and reported to the NRC.
The NRC is concerned not only with the adequacy of Amersham's tests, but also that Amersham's quality assurance program did not disclose these problems.
The letter to Amersham confirms that the company's suspension of fabrication of NRC-certified transportation packages will continue in effect until the company receives authorization to resume from the NRC.
In addition, the letter confirms that Amersham will:
(1) Submit to NRC by June 16, justification for all NRC-certified packages as to why there are no immediate health and safety concerns regarding the continued use of the packages.
(2) Notify all users of Amersham packages by June 16 of the questions that were raised by NRC regarding the packages, and that retesting will be performed. Amersham will also advise users of any administrative controls to ensure safe transport that they should take prior to completion of Amersham's retesting.
(3) Submit to NRC by June 16 a report on an independent assessment of the drop test pad that was used in the testing program.
(4) Retest the transportation packages to demonstrate that their designs meet the requirements of NRC regulations. Before retesting, Amersham will obtain the services of an independent testing expert (to be approved by NRC) and will prepare and submit to the NRC detailed test plans and procedures. Amersham will give NRC two days notice prior to each test and will not proceed to retest without agreement from the NRC. All testing will be completed by not later than six months from NRC approval of the test plans. (5) Submit to NRC by June 23 a plan to modify the company's quality assurance program to ensure adequate packaging design and testing.
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