[Federal Register Volume 70, Number 139 (Thursday, July 21, 2005)]
[Notices]
[Pages 42108-42110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14358]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 71-0122; Approval No. 0122; EA-01-164]
In the Matter of J. L. Shepherd & Associates; San Fernando, CA;
Confirmatory Order Rescinding Order (Effective Immediately)
I
J. L. Shepherd & Associates (JLS&A) was the holder of Quality
Assurance (QA) Program Approval for Radioactive Material Packages No.
0122 (Approval No. 0122), issued by the U.S. Nuclear Regulatory
Commission (NRC or Commission) pursuant to 10 CFR Part 71, Subpart H.
The approval was originally issued January 17, 1980, pursuant to the QA
requirements of 10 CFR 71.101. QA activities included: design,
procurement, fabrication, assembly, testing, modification, maintenance,
repair, and use of transportation packages subject to the provisions of
10 CFR Part 71. In addition to an NRC-approved QA program satisfying
the provisions of 10 CFR Part 71, Subpart H, JLS&A was required to
comply with the requirements in 10 CFR Part 71, Subpart C, which grants
a general license authorizing licensed material for which a Certificate
of Compliance (CoC) had been issued by the NRC to be transported or
delivered to a carrier for transport. Based on JLS&A failure to comply
with these requirements, QA Program Approval No. 0122 was withdrawn, by
the immediately effective NRC Order, dated July 3, 2001 (July 2001
Order) (66 FR 36603, July 12, 2001).
II
The NRC issued the July 2001 Order because the NRC lacked
confidence that JLS&A was implementing its NRC-approved QA Program (71-
0122, Revision No. 5) in full conformance with the terms and conditions
of an NRC CoC and with 10 CFR Part 71, Subpart H.
On several occasions subsequent to imposition of the July 2001
Order, JLS&A has requested, based on its proposed Near-Term Corrective
Action Plan (NTCAP), interim relief from the July 2001 Order to allow
shipments in U.S. Department of Transportation (DOT) specification
packaging designated as 20WC. On August 17, 2001, in response to the
July 2001 Order, JLS&A requested interim relief pursuant to its
proposed NTCAP to allow 68 shipments to 16 customers, subject to
JLS&A's commitment to take certain actions regarding implementation of
its 10 CFR Part 71 QA Program. On September 19, 2001, the NRC issued a
Confirmatory Order Relaxing the July 3, 2001, Order (September 2001
Order) based on JLS&A commitment to hold all shipments until NRC
completed an inspection which confirmed JLS&A's satisfactory completion
of the actions identified in its August request. Subsequent to
certifications under oath and affirmation from both the Independent
Auditor and J. L. Shepherd, the President of JLS&A, that the conditions
for issuance of an Order had been met, the NRC conducted an inspection
at the JLS&A facility on November 13-15, 2001. As a result of the
inspection findings, the inspection team authorized JLS&A to commence
the shipments in accordance with the September 2001 Order.
By letter dated December 7, 2001, JLS&A requested that provisions
of the July 2001 Order be relaxed based on a showing of good cause.
Specifically, JLS&A requested interim relief to ship an irradiator to
Surry Nuclear Power Station and return the replaced unit to JLS&A's
facility in California. JLS&A proposed to use the NTCAP specified in
the September 2001 Order to authorize these two shipments in DOT
specification packaging designated as 20WC. The NRC Staff reviewed
JLS&A's relief request to determine whether the requested relief would
be consistent with assurances that public health and safety are
maintained. As a result, the NRC issued a Confirmatory Order Relaxing
Order dated December 13, 2002 (December 2002 Order), which relaxed the
July 2001 Order to grant interim relief to allow two shipments to one
customer in 20WC packages in accordance with JLS&A's NTCAP, provided
certain commitments were met.
By letters dated February 26, 2002, as supplemented March 13, 18,
and 25, 2002, JLS&A requested that provisions of the July 2001 Order be
relaxed based on a showing of good cause. Specifically, JLS&A requested
an extension of the September 2001 Order expiration date from March 31,
2002 to June 30, 2002, to authorize JLS&A to
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complete shipment of Type B quantities of radioactive material in DOT
20WC specification packaging that was authorized by the September 2001
Order. The extension of the expiration date was necessary since many of
the JLS&A customers did not obtain the necessary licensing approval or
building modification in time for the shipments to be completed by
March 31, 2002. In addition, JLS&A requested authorization to make
additional shipment to customers not approved by the September 2001
Order. JLS&A proposed to use the NTCAP specified in the September 2001
Order. JLS&A committed to: (1) Inspect the 20WC package (both shield
and overpack); (2) document the inspection in a separate report; (3)
perform the shipping and inspection function only by trained personnel;
and (4) have the Independent Auditor verify compliance of each shipment
with the foregoing commitments and certify such compliance in the
routine monthly reports to the NRC.
This Order only granted additional time to complete the shipments
previously authorized by the September 2001 Order to be completed by
March 31, 2002. On February 26, 2002, JLS&A consented to issuance of a
Confirmatory Order (February 2002 Order) granting interim relief from
the July 2001 Order subject to the commitments, as described, agreed
that the Confirmatory Order would be effective upon issuance, and
agreed to waive its right to a hearing on this action. Implementation
of these commitments, as described, provided assurance that sufficient
resources were applied to the QA program, and that the program would be
conducted safely and in accordance with NRC requirements.
In response to JLS&A's most recent request for interim relief, and
based on a showing of good cause, the NRC issued a Confirmatory Order
dated May 30, 2003, Confirmatory Order Relaxing Order (May 2003 Order)
(68 FR 34010, June 6, 2003), that allowed JLS&A to make shipments
through June 1, 2005, and expanded JLS&A's shipment authorization to
transportation packaging as authorized by JLS&A's implementation of
Revision 7 of the conditionally approved QA Program Approval No. 0122.
The May 2003 Order contained an expiration date of June 1, 2005.
By letter dated April 7, 2005, JLS&A requested the NRC to rescind
the July 2001 Order that withdrew JLS&A's Quality Assurance Program
Approval No. 0122. Because the Staff's review of JLS&A's request could
not be completed by June 1, 2005, the Staff issued a Confirmatory Order
on June 1, 2005, which extended the expiration date of the May 2003
Order to July 1, 2005 (70 FR 34165, June 13, 2005), to allow JLS&A to
continue limited operations under Revision 7 of the conditionally
approved QA Program Approval No. 0122, while the Staff completed its
review.
III
The Staff has completed its review and concluded that the July 2001
Order should be rescinded. JLS&A has completed all of the elements of
its NTCAP and has demonstrated, on multiple occasions after relaxation
of the July 2001 Order, that it can safely transport Type B radioactive
shipments in both DOT Specification 20WC overpacks and NRC-approved CoC
packages under their new NRC-approved QA program. In addition, the NRC
Spent Fuel Project Office has inspected JLS&A in 2003 and again in 2004
and although minor program implementation deficiencies were found,
these findings were of lower safety significance and none were of a
severity level comparable to the original findings which precipitated
the issuance of the July 2001 Order. In addition, in JLS&A's April 7,
2005 letter, JLS&A committed to the following conditions:
1. JLS&A shall continue implementing its new QA Procedures such
that reviews are conducted to ensure that all activities under the
scope of Part 71 are governed by procedures defining the activity,
documenting the activity, and providing audit trail of the activity
performed.
2. The Independent Auditor shall continue to perform quarterly
audits verifying the implementation of the conditionally approved JLS&A
Quality Assurance Program Plan and Implementing Procedures. Reports
shall be provided quarterly by the 20th day of the month following
completion of the audit. Any areas of nonconformance, not self
identified by JLS&A, shall be reported to NRC.
3. JLS&A shall keep monthly statistics regarding QA Program
implementation and procedure adherence. Such statistics shall include
the number of nonconformances, the nature of the nonconformances, and
indicate those nonconformances that are referred to the corrective
action processes. Such information shall be provided to the Independent
Auditor who will report any areas of concern to NRC during scheduled
reports.
4. JLS&A shall immediately stop work or cause to be stopped any
work which would result in a potential hazard to public health and
safety.
5. Conditions 1 though 4 shall remain in effect for one year from
date of rescission of the July 3 Order, or until the Independent
Auditor shall issue four successive quarterly reports that show no
violation of NRC regulations and effective implementation of the JLS&A
Quality Assurance Program.
On June 23, 2005, JLS&A consented to issuance of this Order with
the commitments, as described in Section IV below. JLS&A further agreed
in its June 23, 2005, letter that this Order is to be effective upon
issuance and that it waived its right to a hearing. Implementation of
these commitments will provide enhanced assurance that sufficient
resources will be applied to JLS&A's Quality Assurance Program Plan and
Implementing Procedures, and that the plan and procedures will be
conducted safely and in accordance with NRC requirements. I find
JLS&A's commitments as set forth in Section IV 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 JLS&A's commitments be
by this Order. Based on the above and JLS&A's consent, this Order is
immediately effective upon issuance.
IV
Accordingly, pursuant to Sections 62, 81, 161b, 161i, 161o, 182 and
186 of the Atomic Energy Act of 1954, as amended, and the Commission's
regulations in 10 CFR Section 2.202 and 10 CFR parts 71 and 110, it is
hereby ordered, effective immediately, that the July 3, 2001, Order is
rescinded, reinstating JLS&A's quality assurance program approval and
granting relief to J. L. Shepherd and Associates to allow full
participation in 10 CFR part 71 transportation activities in accordance
with NRC-approved quality assurance program approval, revision 7, based
on the following conditions:
1. JLS&A shall continue implementing its new QA Procedures. Reviews
shall be conducted to ensure that all activities under the scope of 10
CFR part 71 are governed by procedures defining the activity,
documenting the activity, and providing an audit trail of the activity
performed.
2. The Independent Auditor shall continue to perform quarterly
audits verifying the implementation of the conditionally approved JLS&A
Quality Assurance Program Plan and Implementing Procedures. Reports
shall be provided quarterly by the 20th day of the month following
completion of the audit. Any areas of nonconformance
[[Page 42110]]
included in such reports that are not self identified by JLS&A, shall
also be reported to NRC, in writing, by the 20th day of the month
following completion of the audit.
3. JLS&A shall keep monthly statistics regarding QA Program
implementation and procedure adherence. Such statistics shall include
the number of nonconformances, the nature of the nonconformances, and
those nonconformances referred to the corrective action processes. Such
information shall be provided to the Independent Auditor who will
report any areas of concern to NRC through scheduled reports.
4. JLS&A shall immediately stop work or cause to be stopped any
work which would result in a potential hazard to public health and
safety.
5. Conditions 1 though 4 shall remain in effect for one year from
date of rescission of the July 3 Order, or until the Independent
Auditor shall issue four successive quarterly reports that show no
violation of NRC regulations and effective implementation of the JLS&A
Quality Assurance Program, whichever is later.
The Director, Office of Enforcement, may in writing, relax or
rescind any of the above conditions upon demonstration by JLS&A of good
cause.
V
Any person adversely affected by this Confirmatory Order, other
than the Certificate Holder, 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: Rulemakings and Adjudications Staff, 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 Materials Litigation and
Enforcement at the same address, to the Regional Administrator, NRC
Region IV, 611 Ryan Plaza Drive, Suite 400, Arlington, TX 76011 and to
JLS&A. Because of continuing disruptions in delivery of mail to United
States Government offices, it is requested that answers and requests
for hearing be transmitted to the Secretary of the Commission either by
means of facsimile transmission to 301-415-1101 or by e-mail to
[email protected] and also to the Office of the General Counsel
either by means of facsimile transmission to 301-415-3725 or by e-mail
to [email protected]. If a person other than the licensee 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 2.309(d) and (f).
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.
Dated this 30th day of June, 2005.
For the Nuclear Regulatory Commission.
Michael R. Johnson,
Director, Office of Enforcement.
[FR Doc. 05-14358 Filed 7-20-05; 8:45 am]
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