ML20133F833

Order Modifying License 99990004 to Read as Stated

ML20133F833
Person / Time
Issue date:	01/13/1997
From:	Lieberman J NRC OFFICE OF ENFORCEMENT (OE)
To:	NDC SYSTEMS
Shared Package
ML20133F817	List: ML20133F813 ML20133F821 ML20133F833
References
REF-QA-99990004-970113 EA-96-342, NUDOCS 9701150025
Download: ML20133F833 (10)

Text

-- -. .. - - . ... . .- . .- - ._.

UNITED STATES NUCLEAR REGULATORY COMMISSION y

In the Matter of )

) Docket No. 999-90004 NDC SYSTEMS ) General License Pursuant Irwindale, California ) to Part 110

) EA 96-342 CONFIRMATORY ORDER MODIFYING LICENSE (EFFECTIVE IMMEDIATELY)

I NDC Systems (NDC or Licensee) has been granted a General License pursuant to the provisions of 10 CFR 110.19, 110.20, and 110.23. The General License authorizes the Licensee to export licensed material in accordance with the provisions contained therein.

II Based on the NRC's investigation conducted from April 12 through August 28, 1996, at NDC's facility in Irwindale, California, and a predecisional enforcement conference held on October 23, 1996, the NRC has concluded that a violation of NRC requirements occurred. The violation involved the willful failure to comply with export requirements (10 CFR 110.50) in that packaging of certain gauging devices containing americium-241 (Am-241) was not in accordance with Department of Transportation (DOT) requirements.

The Commission's regulations in 10 CFR 110.50(a) and 10 CFR 71.5(a) require NDC, as a general licensee, to comply with the applicable D0T requirements in 49 CFR Parts 170 through 189. Prior to November 1, 1995, DOT requirements in 49 CFR Sections 171.ll(d), 171.12(d), 173.422, 173.423, 173.431, and 173.475 required shippers to ensure that radioactive materials are packaged properly, 9701150025 970113 REG 4 GA999 ENVNDC 99990004 pop I

d e

S 4

with Type A packaging required for packages containing materials having total activity greater than 80 millicuries, and packages ccntaining materials having l l

total activity equal to or less than 80 millicuries being excepted from this requirement. Prior to November 1, 1995, however, NDC systems delivered I gauging devices containing 150 millicuries of americium-241 sources for transport by air to foreign countries in excepted packaging, not in Type A packaging.

NDC representatives stated that the circumstances surrounding the failure to l comply with 00T requirements began around 1989 with the practice of improperly labeling gauges that were going to certain countries. Gauges going to certain countries were purposefully mislabeled to reflect a lower activity of 25 mci, even though NDC personnel knew that the gauges contained 150 mci. (This occurred after Amersham, the manufacturer of the sources, began shipping to NDC 150 mci cylinder sources rather than 25 mci disk sources.) Since the lower activity was within the D0T limit for excepted packaging, NDC personnel improperly packaged the mislabeled gauges in excepted packaging rather than the required Type A packaging. Thus, NDC shipping personnel were packaging and sending gauges going to certain countries in excepted packaging, while the same model gauges, with the same sources, were shipped to other countries in Type A packaging. However, NDC personnel stated that they did not realize they were violating DOT requirements.

Some NDC personnel stated that they raised concerns about the practice of mislabeling the gauge to senior NDC management on a number of occasions.

Although NDC senior management agreed the practice was improper, NDC personnel

i i  :

4 a

were instructed to continue the practice despite their concerns. At the i

l conference, NDC senior management stated that it condoned this inappropriate j practice with the rationalization that it would be a temporary practice until the devices were registered in those certain countries. All involved NDC j personnel stated that there was no discussion of mispackaging the devices j which was the natural consequence of the mislabeling. Due to NDC senior management's admitted " sloppy" practices and total lack of oversight, NDC i

i senior management inadequately evaluated the mislabeling concern and did not i

i i consider that the mislabeling would result in mispackaging. Thus, the NRC has l i l

{ concluded that this violation was willful based, at least, on the careless  !

{ disregard by senior NDC management of applicable requirements.

! l NDC stated that the root causes of the violation are: (1) a lack of f' estagement oversight of the NDC shipping program to ensure compliance with DOT i

i regulations and (2) a lack of a thorough understanding of applicable D0T

! regulations.

During the October 23 predecisional enforcement conference, NDC proposed i various corrective actions that it had taken and planned to take to preclude j recurrence of this violation and future DOT violations. In later discussions

with NDC, the corrective actions were enhanced to address specific NRC concerns.

1 4

)

. III 1

By letter dated November 21, 1996, the NRC described to the Licensee the NRC's l understanding of the Licensee's modified corrective actions. The Licensee subsequently consented to issuing this Order with the conditions, as described I in Section IV below, in a letter signed on November 29, 1996. The Licensee 1

further agreed that this Order be immediately effective and that its hearing rights be waived. The NRC has reviewed the above conditions and concludes  !

that implementation of these actions would provide enhanced assurance that sufficient resources will be applied to the radiation safety program, and that the program will be conducted safely and in accordance with NRC requirements.

I find that the Licensee's commitments as~ set forth in Section IV are acceptable and necessary, and conclude that with these commitments the public health and safety are reasonably assured. In view of the foregoing, I have  !

determined that the public health and safety require that the Licensee's  ;

1 commitments in its November 29, 1996, letter, be confirmed by this Order.

Based on the above and on the Licensee's consent, this Order is immediately effective upon issuance.

IV Accordingly, pursuant to sections 81, 161b, 1611, 1610, 182 and 186 of the Atomic Energy Act of 1954, as amended, and the Commission's regulations in 10 CFR 2.202 and 10 CFR Part 110, IT IS HEREBY ORDERED, EFFECTIVE IMMEDIATELY, THAT NDC'S GENERAL LICENSE PURSUANT T0 10 CFR PART 110 IS MODIFIED AS FOLLOWS:

+

A. NDC shall retain the services of an independent individual or organization (consultant) to perform two audits of the Licensee's i I  !

j activities conducted under the general license, and shall provide the j l

NRC with reports of the audits' findings as described in Provisions D and E below. The audits shall include, but are not limited to:

i (1) review of export activities, including NDC's compliance with Department of Transportation (DOT) regulations; i

(2) discussion and interviews with NDC employees to verify that ,

i employees understand D0T regulations as they relate to NDC's '

shipping activities and to verify the effectiveness of NDC's corrective actions to the violation identified in the Order;

! (3) discussion and interviews with NDC employees to verify that NDC employees have been adequately trained on and understand NDC's l procedures and policies for raising safety concerns and for seeking guidance related to NRC-licensed activities; and i

} (4) discussion and interviews with NDC employees to determine whether employees have concerns about NDC's policies or procedures for raising safety issues and for seeking guidance.

B. Within 30 days of the date of the Order, NDC shall submit to the NRC, for NRC review and approval, the name and qualifications of the consultant it proposes to use in conducting these audits. The

, . l consultant shall be independent of the Licensee's organization and shall be experienced in performing evaluations of NRC or Agreement State l licensee programs with respect to implementation of the Department of Transportation (DOT) regulations.

1

C. Prior to supervising or performing any shipping activities, and no later than 60 days after the date of the Order, NDC will provide formal classroom training consistent with the training requirements of 49 CFR

] Part 172 Subpart H. All individuals who are involved in shipping activities, the Shipping Supervisor and Operations Manager, and the

] individual or individuals with responsibility for oversight of the radiation safety program, are subject to this commitment.

i l For the purpose of the Order, shipping activities include tasks such as

, packaging, labeling, and completion of appropriate transportation

! documents.

D. Within 60 days of the date of NRC's approval of a consultant, NDC shall provide the hRC with a copy of the first audit report, including a description of actions taken and planned in response to any recommendations, comments, or findings in the audit report.

Alternatively, if NDC does not believe any specific recommendation should be adopted or an audit finding should not be addressed, NDC will provide justification for its position to the NRC.

1 1

i .

E. Within 12-18 months of the date of the Order, NDC shall provide the NRC with a copy of the second audit report, including a description of actions taken and planned in response to any recommendations, comments, or findings in the audit report. Alternatively, if NDC does not believe any specific recommendation should be adopted or an audit finding should not be addressed, NDC will provide justification for its position to the i NRC. If NDC chooses to use a different auditor for this audit, NDC shall submit the qualifications of the auditor to the NRC for approval prior to conducting the audit. l l

F. For the purpose of the Order, NDC shall send the audits and its responses, and the qualifications of the auditor, to the Director, Division of Nuclear Material Safety, NRC Region IV, 611 Ryan Plaza i

l Drive, Suite 400, Arlington, Texas 76011, and a copy to Chief, Materials Branch, NRC WCF0, 1450 Maria Lane, Walnut Creek California 94596-5368.

A j The Regional Administrator, Region IV, may relax or rescind, in writing, any of the above conditions upon a showing by the Licensee of good cause.

i V

i 4

j Any person adversely affected by this Confirmatory Order, other than the i

J Licensee, may request a hearing within 20 days of its issuance. Where good cause is shown, consideration will be given to extending the time to request a hearing. A request for extension of time must be made in writing to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission

l^

. _g_

Washington, D.C. 20555, and include a statement of good cause for the extension. Any request for a hearing shall be submitted to the Secretary, U.S. Nuclear Regulatory Commission, ATTN: Chief, Docketing and Service Section, Washington, D.C. 20555. Copies also shall be sent to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, to the Assistant General Counsel for Hearings and Enforcement at -

the same address, to the Regional Administrator, NRC Region IV, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011, and to the Licensee. If such a person requests a hearing, that person shall set forth with particularity the '

manner in which his interest is adversely affected by this Order and shall address the criteria sat forth in 10 CFR 2.714(d).

If a hearing is requested by a person whose interest is adversely affected, the Commission will issue an Order designating the time and place of any hearing. If a hearing is held, the issue to be considered at such hearing shall be whether this Confirmatory Order should be sustained.

In the absence of any request for hearing, or written approval of an extension of time in which to request a hearing, the provisions specified in Section IV above shall be final 20 days from the date of this Order without further order or proceedings. If an extension of time for requesting a hearing has been approved, the provisions specified in Section IV shall be final when the

]

I 4

I

_9_

j extension expires if a hearing request has not been received. AN ANSWER OR A REQUEST FOR HEARING SHALL NOT STAY THE IMMEDIATE EFFECTIVENESS OF THIS ORDER. )

I I

4 FOR THE NUCLEAR REGULATORY COMMISSION 1

< \

j y r~ w u --

l James Lieberman, Director Office of Enforcement Dated at Rockville, Maryland this l3thday of January 1997 i

)

1

-. - -I

,' January 13, 1997 NDC Systems DISTRIBUTION:

PDR <

Enforcement Coordinators SECY RI, RII, RIII r

.CA .- JGilliland, OPA (0-2G4)

HThompson, E00 (0-17G21) PLohaus, OSP (0-3023)

EJordan,'DE00 (0-17G21) -' HBell, OIG (T-5028)

.JLieberman,>0E (0-7H5) , GCaputo, OI (0-3E4)

LChandler, OGC (0-15B18)- DCool, NMSS or-(T-8F5) 1 JGoldberg, 0GC (0-15B18) OE:ES (0-7H5):

" CPaperiello, NMSS (T-8A23) NUDOCS

. ,0E:EA (0-7H5) IE 14

'LTremper,'0C/LFDCB (T-9E10) RStoiber, IP RIV DISTRIBUTION

-

E-mail to: -

OEMAIL ' TPGwynn (TPG) SJCollins (SJCl)

-RWise (RXW) GMVasquez (GMV) DKunihiro (DMK1) )

- BHenderson (BWH) MHammond-(MFH2) WBrown (WLB)

'CHackney (CAH) JHorner-(JWH3) LHowell (LLH)

RScarano (RAS 1) LWilliamson (ELWl) BSpitzberg (DBS)

CCain (CLC) FWenslawski (FAW) KPrendergast (KMP)

Copies to: j RIV Files GSanborn>EAFile '

WCF0 Files NMI&FCDB File MIS Coordinator RSLO PA0 (Hammond) LJCallan* Reading File i

s \

OE h_h OGC ALA' RA:RIV pW NMSS JS D: h NMamish JGoldberg LJCallan N DCool diebbrman 01/ 7 /97 01/ 6/97 01/io/97 01//c'/97 01//0/97

' f.) L O Doc Name: 6:\0ECASES\96342REV.NM J