[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
