EA-97-541 - Nordion Internaltional, Inc.

January 23, 1998

EA No. 97-541

Mr. Ronald McGregor, Manager
Regulatory Affairs
MDS Nordion Incorporated
447 March Road
Kanata, Ontario, Canada K2K 1X8

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-30788/97-001)

Dear Mr. McGregor:

This refers to the inspection conducted on September 17-19, 1997, at 447 March Road Kanata, Ontario, Canada. The inspection was limited to a review of your manufacturing process as it relates to conformance with your license, registration certificates and quality assurance program. The inspection was conducted to review your distribution of nuclear gauging devices to general licensees. During the inspection, violations of NRC requirements were identified, as described in the NRC inspection report transmitted with our letter dated December 9, 1997. In addition, in the December 9, 1997 letter, the NRC provided you an opportunity to either respond in writing to the apparent violations addressed in the inspection report or request a predecisional enforcement conference. You responded to the apparent violations in a January 13, 1998 letter to the NRC.

Based on the information developed during the inspection and the information you provided in your January 13,1998 response to the inspection report, the NRC has determined that four violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. The violations involve modification to devices without obtaining NRC approval prior to the modifications. The NRC is concerned that the number of deviations between the devices being distributed and the registration certificates, is indicative of a lack of management oversight and understanding of regulatory requirements.

While the specific modifications to the sources, source holder or source drive mechanism do not appear to constitute a safety concern, making such changes without NRC approval constitutes a significant regulatory concern because the NRC was not give the opportunity, as required, to review the changes, and as such, the devices were distributed without an NRC approved registry certificate as required by 10 CFR 32.210. Therefore, the violations demonstrate a significant lack of oversight and control of licensed activities. As such, the violations have been classified in the aggregate as a Severity Level III problem in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation. Because your facility has not been the subject of an escalated enforcement action within the last two years, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions were both prompt and comprehensive. These actions, which were described in your January 13, 1998 letter to the NRC, included, but were not limited to: submittal of current drawings of the C-188 source, C-3001 source and GC-3000 source holder to the NRC Sealed Source and Device Safety Section on September 25, 1997 in order to amend the registration of these devices; and submitting further information on the changes to the GC-40 source movement to amend its registration by February 27, 1998. In addition, you met with the NRC on October 29, 1997 and have made changes in your practices to prevent recurrence of the violations, including training of personnel.

Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action.

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in your letter to the NRC dated January 13, 1998. Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, and its enclosure, as well as your response if your choose to provide one, will be placed in the NRC Public Document Room (PDR).

Sincerely,

Hubert J. Miller Regional Administrator

Docket No. 030-30788
License No. 54-28275-01

Enclosure: Notice of Violation

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NOTICE OF VIOLATION

MDS Nordion Incorporated Kanata, Ontario, Canada

Docket No. 030-30788 License No. 54-28275-01 EA 97-541

During an NRC inspection conducted on September 17-19, 1997, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, the violations are listed below:

10 CFR 32.210(a) states that a manufacturer or initial distributor of a sealed source or device containing a sealed source whose product is intended for use under a specific license may submit a request to the NRC for evaluation of radiation safety information about its product and for its registration.

10 CFR 32.210(f)(1) and (2) states that the person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with (1) the statements and representations, including quality control program contained in the request and (2) the provisions of the registration certificate.

Contrary to the above, from February 11, 1992 to March 14, 1996, the licensee, after having submitted requests to the NRC for evaluation of radiation safety information about its product and for its registration, manufactured and distributed certain sealed sources and devices containing licensed material in a manner that was not in accordance with the provisions of the registration certificate, as evidenced by the following examples, each of which constitutes a separate violation.

1. In support of Registration Certificate NR-0220-D-102-S, Nordion specified, in a June 4, 1993, letter, the specific overall length of the source holder assembly for the Gammacell 3000; however, on May 31, 1993, the licensee had modified the overall length of the source holder assembly for the Gammacell 3000 such that the length was not consistent with the length specified in the June 4, 1993 letter. (01013)

2. In support of Registration Certificate NR-0220-S-103-S, Nordion specified, in its December 20, 1984 letter, the specific length of the outer body of the C-188 sealed source; however, on August 31, 1993, the licensee modified the overall length of the outer capsule of the C-188 sealed source. (01023)

3. Registration Certificate NR-0220-D-101-S specifies that "Irradiation is accomplished by moving two lead-filled cylindrical drawers, each containing a single radioactive source, simultaneously by pneumatic controls from the stored to the irradiate position;" however, in 1995, the licensee modified the source drive mechanism of the Gammacell 40 from a pneumatic system to a ball screw system. (01033)

4. In support of Registration Certificate NR-0220-D-101-S, Nordion specified, in its March 18, 1993, letter, the specific length and diameter for the inner capsule for the Model C-3001 source assembly; however, on March 15, 1996, the licensee modified the overall length and diameter of the inner capsule of the C-3001 source assembly. (01043)

These violations are categorized in the aggregate as a Severity Level III problem (Supplement VI).

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in a letter from the Licensee dated January 13, 1998. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a "Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555 with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

Dated at King of Prussia, Pennsylvania
this 23^rd day of January 1998