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EA-04-118 - Baxter Healthcare CorporationJanuary 26, 2005
Jorge A. Perera
Dear Mr. Perera: The enclosed Confirmatory Order is being issued to the Baxter Healthcare Corporation (Baxter) to confirm recent commitments made to the NRC. The commitments were made by Baxter as part of a settlement agreement between Baxter and the NRC concerning a Notice of Violation and Proposed Imposition of a Civil Penalty (Notice) issued by the NRC on October 25, 2004. In that Notice, the NRC (1) documented six violations of NRC requirements, (2) characterized one of the six violations as willful, and (3) proposed a civil penalty in the amount of $44,400 for the three violations that were set forth in Section I of the Notice. A civil penalty was not proposed for the other three violations that were set forth in Section II of the Notice. In response to that Notice, Baxter requested use of the NRC Alternate Dispute Resolution Process (ADR) to resolve differences it had with the NRC concerning the Notice. An ADR mediation session was held between Baxter and NRC in Philadelphia, Pennsylvania on December 13, 2004, at which the settlement agreement was reached. The elements of the settlement agreement were formulated and agreed to at the mediation session, were documented in a letter from Mr. Peter Etienne, Senior Counsel, Baxter, to the NRC on December 17, 2004, and are also contained in Section III of the enclosed Order. As part of the settlement agreement, Baxter agreed to pay a civil penalty in the amount of $31,200 and take additional corrective actions. The NRC agreed to characterize the three violations in Section I of the Notice as a one Severity Level II problem, and to characterize the other violations in Section II of the Notice as noncited violations. Baxter and the NRC also agreed to disagree on the willful characterization of Violation I.C. Pursuant to Section 223 of the Atomic Energy Act of 1954, as amended, any person who willfully violates, attempts to violate, or conspires to violate, any provision of this Order shall be subject to criminal prosecution as set forth in that section. Violation of this Order may also subject the person to civil monetary penalties. Questions concerning this Order should be addressed to Sally Merchant, Office of Enforcement, who can be reached at 301-415-2747. A copy of this letter and its enclosure will be made available electronically for public inspection in the NRC Public Document Room or from the NRC’s document system (ADAMS), accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html. To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction. The NRC also includes significant enforcement actions on its Web site at ; select What We Do, Enforcement, then Significant Enforcement Actions.
Docket No. 030-19882 Enclosure: Confirmatory Order (Effective Immediately) [7590-01-P] UNITED STATES OF AMERICA
CONFIRMATORY ORDER MODIFYING LICENSE I Baxter Health Care Corporation (Baxter or Licensee) is the holder of NRC License No. 52-21175-01 (License) which authorizes the Licensee to operator an irradiator at its facility in Aibonito, Puerto Rico. II 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 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 ©) 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. III 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:
IV 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. V 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 C.F.R. §2.202 and 10 C.F.R. Part 30, IT IS HEREBY ORDERED, EFFECTIVE IMMEDIATELY THAT:
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. VI 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, D.C. 20555. Copies of the hearing request shall also be sent to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington D.C. 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 hearing.docket@nrc.gov and also to the Office of the General Counsel by means of facsimile transmission to 301-415-3725 or e-mail to OGCMailCenter.Resource@nrc.gov. 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 C.F.R. § 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.
Dated this 26th day of January 2005 |
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