[Federal Register Volume 70, Number 22 (Thursday, February 3, 2005)]
[Notices]
[Pages 5707-5708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2026]
=======================================================================
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[Docket No. 30-19882, License No. 52-21175-01, EA-04-118]
Baxter Health Care, Aibonito, PR; Confirmatory Order Modifying
License (Effective Immediately)
Baxter Health Care Corporation (Baxter or Licensee) is the holder
of NRC License No. 52-21175-01 (License) which authorizes the Licensee
to operate an irradiator at its facility in Aibonito, Puerto Rico.
On October 25, 2004, the NRC issued a Notice of Violation and
Proposed Imposition of Civil Penalties (Notice) in the amount of
$44,400 to Baxter Healthcare Corporation (Baxter) based on six
violations of NRC requirements. The circumstances associated with these
violations were reviewed by the NRC during an Augmented Inspection Team
(AIT) inspection conducted between April 22, 2004, and June 1, 2004,
after a Baxter representative informed the NRC on April 21, 2004, that
an event had occurred at the facility. The event involved two
individuals (an irradiator operator and assistant) bypassing safety
interlocks and entering the irradiator at a time when an irradiator
source rack (containing 2,000,000 curies of cobalt-60) was stuck in an
unshielded position.
The three most significant violations cited by the NRC in its
October 25, 2004 Notice were described in Section I. The first
violation cited in Section I of the Notice involved the failure to
adhere to emergency and abnormal event procedures when the safety
interlocks were bypassed even though the irradiator source rack fault
indicator was illuminated and the source travel alarm had sounded for
an extended period. This occurred on at least three occasions,
including when the source rack was stuck in the unshielded position on
April 21, 2004. This created the potential for a lethal exposure to
radiation for the two individuals who entered the area while the
sources were exposed, since, as previously indicated, the individuals
passed through an area with a radiation level at least as high as 1600
rads/hour, and were planning to enter an area with much higher
radiation levels (as high as 100,000 rads/hour in the irradiator cell).
By bypassing the safety interlocks, a system designed to prevent a
serious safety event was rendered inoperable, which created the
potential for significant injury and loss of life. Therefore, in the
Notice, the NRC classified this violation at Severity Level II and
proposed a civil penalty in the amount of $28,800 ($9,600 for each of
the minimum three occasions that the violation occurred).
The second violation cited set forth in Section I involved the
failure to perform an adequate survey prior to the two individuals
entering the irradiator on April 21, 2004. Prior to the entry, the
operators did not adequately check the irradiator cell radiation
monitor, did not adequately check the radiation levels outside the
irradiator facility, and did not adequately do other such surveys as
were reasonable to determine that a source rack was stuck in the
unshielded position and had not returned to the fully shielded
position. The NRC also classified this violation at Severity Level II
and proposed a $9,600 civil penalty for the violation.
The third violation cited by the NRC in Section I of the Notice
involved the failure by the irradiator operator to supply his assistant
an individual radiation monitoring device when the two individuals
entered the irradiator on April 21, 2004, while a source rack was stuck
in the unshielded position. Based on the OI investigation, the NRC
concluded that this violation was willful. The NRC classified this
violation at Severity Level III and proposed a $6,000 civil penalty.
The letter transmitting the Notice also described the Licensee's
corrective actions, which included, but were not limited to: (1)
Revision to procedures for responding to emergency conditions and
performing necessary surveys; (2) plans to annually review the standard
operating procedures for adequacy; (3) upgrade of the training program
and retraining of staff on revised procedures, survey techniques, and
dosimetry use; and (4) increased management oversight of the irradiator
program, including: (a) Monthly reviews of the irradiator department by
the Plant General Manager, Manufacturing Director, Radiation Safety
Officer (RSO), and the assistant RSO (ARSO); (b) annual internal audits
of the irradiator by the Environmental Health and Safety Manager and
RSO; and (c) additional periodic audits of the irradiator by the
corporate environmental health and safety group as well as by an
external consultant.
The other three violations cited in the Notice were described in
Section II and the NRC classified those violations at Severity Level
IV.
In response to the October 25, 2004 Notice, Baxter requested use of
the NRC Alternate Dispute Resolution Process (ADR) to resolve
differences it had with the NRC concerning the Notice. ADR is a process
in which a neutral mediator with no decision-making authority assists
the NRC and Baxter in reaching an agreement on resolving any
differences regarding the enforcement action. An ADR session was held
between Baxter and NRC in Philadelphia, Pennsylvania on December 13,
2004, and was mediated by a professional mediator, arranged through
Cornell University's Institute of Conflict Management. During that ADR
session, a settlement agreement was reached. The elements of the
settlement agreement, which were documented in a letter from Mr. Peter
Etienne, Senior Counsel, Baxter, to the NRC on December 17, 2004,
consisted of the following:
A. Baxter agrees to pay a civil penalty of $31,200.00 for
Violations I.A, I.B and I.C. The NRC will characterize these violations
as a Severity Level II problem.
B. Baxter and the NRC agree to disagree on the willful
characterization of Violation I.C.
C. NRC agrees to treat Violations II.A, II.B, and II.C as non-cited
violations.
D. Baxter agrees to implement the corrective action as documented
in Baxter's letter dated August 23, 2004, except that with respect to
item 1(c) in that letter, (``Additional External Review by Outside
Consultant''), that item is replaced by the terms of the December 13,
2004, settlement. Specifically, Baxter agrees to provide for reviews of
irradiator operations to be conducted by a qualified consultant, with
such review to include a review of operations, maintenance, radiation
safety and the RSO and ARSO functions. Review results will be
documented and made available to NRC during inspections conducted by
the NRC. Such reviews to be conducted as noted below.
E. A review by the qualified external consultant will be conducted
in 2005 of the RSO and ARSO function to supplement the reviews done in
2004.
F. In 2007, a qualified external consultant will conduct a full
review as listed in Item D.
[[Page 5708]]
G. In 2007 after the full review, Baxter will discuss with NRC
whether Baxter will need to continue to use a qualified external
consultant. It is anticipated that the last external consultant review
will be completed in 2007. In no event shall such review extend beyond
one additional review in 2009 in the context of this Agreement.
H. Baxter will submit to the NRC a letter within two weeks (by
December 27, 2004) which documents the Agreement. (Met by Baxter's
December 17, 2004 letter).
I. Upon issuance of a Confirmatory Order by the NRC, confirming the
Agreement reached by the parties on December 13, Baxter will pay the
Civil Penalty in the amount of $31,200.00 within thirty days of the
date of issuance of that Confirmatory Order.
Since the licensee has agreed to take additional actions to address
NRC concerns, as set forth in Item III above, the NRC has concluded
that its concerns can be resolved through the NRC's confirmation of the
licensee commitments as outlined in this Order.
I find that the licensee's commitments as set forth in Section III
above are acceptable and conclude that with these commitments, the
public health and safety are reasonably assured. However, in view of
the foregoing, I have determined that public health and safety require
that these commitments be confirmed by this Order. Based on the above
and the licensee's consent, this Order is immediately effective upon
issuance. The licensee is required to provide the NRC with a letter
summarizing all of its actions, up to and including, its last external
consultant review that is to be completed in 2007.
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:
A. Baxter pay a civil penalty of $31,200.00 for Violations I.A, I.B
and I.C. set forth in the NRC October 25, 2004 Notice. (The NRC will
characterize these violations as a Severity Level II problem. Also,
Baxter and the NRC agree to disagree on the willful characterization of
Violation I.C, and the NRC agrees to treat Violations II.A, II.B, and
II.C as non-cited violations).
B. Baxter implement the corrective actions a documented in its
August 23, 2004, letter except that with respect to item 1(c) in that
letter (``Additional External Review by Outside Consultant''), that
item is replaced by the terms of the December 13, 2004, settlement.
Specifically, Baxter will provide for reviews of irradiator operations
to be conducted by a qualified consultant with such review to include a
review of operations, maintenance, radiation safety and the RSO and
ARSO functions. Review results will be documented and made available to
NRC during inspections conducted by NRC. Such reviews to be conducted
as noted below.
1. A review by the qualified external consultant will be conducted
in 2005 of the RSO and ARSO function to supplement the reviews done in
2004.
2. In 2007, a qualified external consultant will conduct a full
review as listed in Item B.
3. In 2007 after the full review, Baxter will discuss with NRC
whether Baxter will need to continue to use a qualified external
consultant, although it is anticipated that the last external
consultant review will be completed in 2007, and in no event, shall
such review extend beyond one additional review in 2009 in the context
of the Agreement.
The Director, Office of Enforcement may relax or rescind, in
writing, any of the above conditions upon a showing by the licensee of
good cause.
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 must
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, Rulemaking and Adjudications Staff,
Washington, DC 20555. Copies of the hearing request shall also 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, to the Director of the Division
of Regulatory Improvement Programs at the same address, and to Baxter.
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 by
means of facsimile transmission to (301) 415-3725 or e-mail to
[email protected]. 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 2.309(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 shall be
sustained. An answer or a request for a hearing shall not stay the
effectiveness date of this order.
Dated this 26th day of January 2005.
For the Nuclear Regulatory Commission.
Frank Congel, Director,
Office of Enforcement.
[FR Doc. 05-2026 Filed 2-2-05; 8:45 am]
BILLING CODE 7590-01-P