[Federal Register Volume 62, Number 127 (Wednesday, July 2, 1997)]
[Notices]
[Pages 35839-35841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17294]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 030-32518; License No. 37-28697-01; EA 96-246]


Apgee Corporation (Aliquippa, PA); Confirmatory Order Modifying 
License (Effective Immediately)

I

    Apgee Corporation (Licensee) is the holder of NRC License No. 37-
28697-01 issued by the Nuclear Regulatory Commission (NRC or 
Commission) pursuant to 10 CFR part 30. The license was initially 
issued on September 30, 1991, and is due to expire on October 31, 2001. 
The license authorizes the possession and use of a variety of 
radionuclides incident to the loading of sealed sources into devices 
prior to transfer. These devices are described in Sealed Source and 
Device (SSD) Registry Certificates, NR-0112-D-101-B, NR-0112-D-102-B, 
NR-0112-D-104-B, NR-0112-D-105-S, NR-0112-D-106-B, NR-0112-D-107-S, NR-
0112-D-108-B, NR-0112-D-109-B, NR-0112-D-110-B, NR-0112-D-111-S, and 
NR-0112-D-112-B issued by the NRC pursuant to 10 CFR part 32. The 
Licensee imports devices manufactured by EG&G Berthold in Germany, 
performs quality assurance checks, and transfers the devices to 
Berthold Systems, Inc. for distribution within the U.S. to specific and 
general licensees. Most of the SSD Registration Certificates referenced 
above were originally issued on October 18, 1991. Registration 
Certificate NR-0112-102-B was issued on April 26, 1996, Registration 
Certificate NR-0112-106-B was issued on October 1, 1992, and 
Registration Certificate NR-0112-D-109-B was issued on February 16, 
1994. Registration Certificates have no expiration date.

II

    On June 11-13, 1996, during an inspection of Apgee Corporation and 
Berthold Systems, Inc., at their Aliquippa, Pennsylvania facility, 
certain apparent violations involving improper distribution of sources 
and devices were identified, as described in Inspection Report Nos. 
030-20043/96-001, 030-21228/96-001 and 030-32518/96-001. As a result, a 
Confirmatory Action Letter (CAL) was issued to the Licensee on June 19, 
1996, requiring the Licensee to perform a comprehensive audit of every 
device and its contained source currently being distributed and 
distributed in the past. In its response to the CAL dated July 19, 
1996, the Licensee confirmed that some of the

[[Page 35840]]

devices manufactured by EG&G Berthold and distributed by the Licensee 
may have deviated from the SSD Certificates of Registration.
    On July 22, 1996, the NRC issued a supplement to the CAL . The 
Licensee submitted further responses to the CAL and Supplement by 
letters dated August 12, and October 15, 1996. By letter dated October 
28, 1996, the NRC requested that the Licensee provide additional 
information in order that the Commission could complete its assessment 
of the safety significance of the identified deviations. This 
information was submitted by the Licensee on November 27, December 4, 
and December 20, 1996.
    By letter dated April 2, 1997, the NRC informed the Licensee that 
it had completed its analysis of the information submitted by the 
Licensee. The letter informed the Licensee that, based upon the results 
of the inspection and the NRC's review of the information provided, 
three apparent violations were identified, including: (1) Distribution 
of devices not in accordance with the conditions of the registration 
certificate or for which a certificate of registration had not been 
issued; (2) failure to conduct audits on a quarterly basis; and (3) 
failure to distribute model LB 7400 series devices with manuals that 
include written instructions advising the customer not to lock the 
device in the open position.
    In an enclosure to its April 2, 1997 letter, the NRC identified 42 
areas of concern regarding 11 types of devices and a number of areas 
for which additional information was still required. The NRC expressed 
safety concerns in its April 2, 1997, letter regarding the following 
devices, which were apparently distributed without conforming to the 
requirements of the applicable registration certificate: (1) LB 7400 
devices with alternate sources; (2) LB 7400 devices with pneumatic 
actuator; (3) LB 7400 devices with carbon steel transport bolts; (4) LB 
300 IPD/L devices with modified source housing lengths; (5) LB 300 IPD/
L devices with new Amersham or Bebig sources; and (6) all LB AS 
devices.
    A predecisional enforcement conference was conducted with the 
Licensee at the NRC Region I office on April 24, 1997, to discuss the 
apparent violations and the concerns identified in the NRC analysis. 
During the enforcement conference, the Licensee indicated that 
organizational weaknesses in its program led to the problems. The 
Licensee also acknowledged that audits of the manufacturing process 
performed by the Licensee were not thorough.
    With regard to the six issues of particular safety concern to the 
NRC, the Licensee indicated that it planned to either: (1) Submit a 
request to amend certain SSD Registry Certificates to address changes 
to the devices; (2) verify that certain devices are in compliance with 
the current Registry Certificates; and/or (3) bring the devices into 
compliance with the current Registry Certificates. In the case of the 
LB 7400 with pneumatic actuator, the only device in the field had 
already been modified to comply with the Registry Certificate. The 
Licensee also indicated that there were no immediate safety concerns 
with any of the devices that were currently in the field. In addition, 
the Licensee agreed to provide the NRC information on those gauges 
where NRC analysis had determined that the information was 
insufficient.

III

    By letter dated May 8, 1997, the NRC documented its understanding 
of the commitments agreed to by the licensee. The letter informed the 
Licensee that the NRC had determined that public health and safety 
required these commitments be confirmed by a Confirmatory Order 
Modifying License (Order), and that these commitments would be 
incorporated into an Order following the Licensee's written consent to 
them. The letter also informed the Licensee that if it consented to the 
issuance of this Order, it would be waiving its right to request a 
hearing on all or any part of the Order, and the letter requested the 
Licensee to sign a Hearing Waiver indicating that it agreed to such 
commitments and consented to the issuance of this Order. On May 19, 
1997, the licensee consented to issuing this Order with the 
commitments, as described in Section IV below, by signing a Hearing 
Waiver. On May 29, 1997, in a telephone conversation between John 
McGrath, USNRC Region I, and G. M. Smith; Apgee Corporation, at NRC's 
request, agreed to an extension of the dates for the commitments 
identified in paragraphs ``C'' and ``E'' of this Order. Implementation 
of these commitments will provide enhanced assurance that sufficient 
resources will be applied to the Licensee's quality assurance program, 
and that distributed devices will comply with their SSD Registry 
Certificate and NRC requirements.
    I find that the Licensee's commitments as set forth in Section IV 
of this Order 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 commitments be confirmed by this 
Order. Based on the above, and the Licensee's consent, this Order is 
immediately effective upon issuance.

IV

    Accordingly, pursuant to sections 81, 161b, 161i, 161o, 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 30, It is hereby ordered, 
effective immediately, that License No. 37-28697-01 is modified as 
follows:
    A. With respect to the LB 7400 devices with alternative sources, 
within seven months of the date of this Order, Apgee shall:
    1. If an amended SSD Registry Certificate is issued to allow for 
the longer source capsules, complete the replacement of the source 
holders in the devices to conform to the amended Registry Certificate; 
or
    2. Recall the devices; or
    3. Bring the devices into compliance with the current SSD Registry 
Certificate.
    B. With respect to the LB 7400 devices with carbon steel transport 
bolts, within seven months of the date of this Order, Apgee shall 
obtain confirmation (e.g., written, telephone, visual verification, 
etc.) that all possessors/users of the gauges have replaced the non-
galvanized bolts with the supplied/authorized galvanized replacement 
bolts as instructed.
    C. With respect to the LB 300 IPD/L devices with modified source 
housing lengths, shield diameters and other changes previously 
identified by Apgee, by July 31, 1997, Apgee shall:
    1. Complete a field inspection of all generally licensed gauges; 
and
    2. Notify the NRC immediately of any identified deviations from the 
SSD Registry Certificate.
    D. With respect to the LB 300 IPD/L devices with new Amersham or 
Bebig sources, within seven months of the date of this Order, Apgee 
shall:
    1. If an amended SSD Registry Certificate is issued to allow for 
the new sources and any other changes to the device that have been 
identified as not being in accordance with the Registry Certificate, 
complete any actions needed to ensure the devices conform to the 
amended Registry Certificate; or
    2. Recall the devices; or
    3. Bring the devices into compliance with the current SSD Registry 
Certificate.
    E. With respect to the LB AS devices, Apgee shall:
    1. By July 31, 1997, recall the devices; or

[[Page 35841]]

    2. By June 30, 1997, provide the NRC with technical justification 
as to the safety of the devices and as to why they should remain in the 
public domain. If the NRC determines that the technical justification 
is inadequate, Apgee shall recall all devices within 15 days of the 
NRC's notification or by July 31, 1997, whichever is the later date.
    F. With respect to the LB 330 Belt Scale devices with increased 
diameter of the source capsule and spacers in the source rod, within 
seven months of the date of this Order, Apgee shall:
    1. If an amended SSD Registry Certificate is issued to allow for 
the 7mm diameter source and spacers and other changes to the devices, 
complete any actions needed to ensure the devices conform to the 
amended Registry Certificate; or
    2. Recall the devices; or
    3. Bring the devices into compliance with the current SSD Registry 
Certificate.
    G. Apgee shall provide, in writing, the following information to 
the Director, Division of Nuclear Materials Safety, NRC Region I, 475 
Allendale Road, King of Prussia, Pennsylvania, 19406:
    1. Within 30 days of the date of this Order, the schedule for 
performance of the required quarterly audits. The NRC shall be notified 
at least 30 days in advance of any change of the scheduled audit dates.
    2. Within 30 days after the completion of each audit, for a period 
of one year from the date of this Order, a report describing the 
results of the quarterly audits. In cases where the audit identifies 
deficiencies in which devices do not comply with the Registry 
Certificate, the report shall include a description of corrective 
action planned to ensure that commitments or requirements are met, a 
schedule for completion of the corrective action, and a basis as to why 
the NRC should not take further enforcement action for the continued 
failure to comply with NRC requirements.
    3. Monthly status reports that include the status of all actions 
required by this Order.
    H. If, for any reason, a date specified in the above conditions 
cannot be met, Apgee shall contact, in writing, Mr. A. Randolph Blough, 
Director, Division of Nuclear Materials Safety, at the address in 
Provision G above.
    The Regional Administrator, Region I, may relax or rescind, in 
writing, any of the above conditions upon a showing by the Licensee of 
good cause.

V

    Any person adversely affected by this Confirmatory Order, other 
than the 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, Washington, DC 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, DC 
20555. Copies also shall be sent to the Director, Office of 
Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, 
to the Assistant General Counsel for Hearings and Enforcement at the 
same address, to the Regional Administrator, NRC Region I, 475 
Allendale Road, King of Prussia, Pennsylvania 19406, 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 set 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 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.

    For the Nuclear Regulatory Commission.

    Dated at Rockville, Maryland this 26th day of June, 1997.

James Lieberman,
Director, Office of Enforcement.
[FR Doc. 97-17294 Filed 7-1-97; 8:45 am]
BILLING CODE 7590-01-P