[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]


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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