United States Nuclear Regulatory Commission

Office of Public Affairs

Washington, DC 20555

Phone 301-415-8200 Fax 301-415-2234

Internet:opa@nrc.gov

No. 97-091 FOR IMMEDIATE

RELEASE

(Thursday, June 12, 1997)

NRC ISSUES LETTER TO AMERSHAM CORPORATION CONFIRMING SUSPENSION

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 freedrop 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 freedrop 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 NRCcertified 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.

###