In the Matter of Baxter Healthcare, Aibonito, Puerto Rico; Confirmatory Order Modifying License (Effective Immediately), 12777-12779 [E8-4716]

Agencies

• NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 73, Number 47 (Monday, March 10, 2008)]
[Notices]
[Pages 12777-12779]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-4716]


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NUCLEAR REGULATORY COMMISSION

[Docket No.: 030-19882; License No: 52-21175-01; EA-07-132]


In the Matter of Baxter Healthcare, Aibonito, Puerto Rico; 
Confirmatory Order Modifying License (Effective Immediately)

I

    Baxter Healthcare of Puerto Rico (Baxter) is the holder of NRC 
Material License No. 52-21175-01 pursuant to 10 CFR part 30 on July 11, 
2005, which authorizes the Licensee to operate an irradiator at its 
facility in Aibonito, Puerto Rico.
    This Confirmatory Order (Order) is the result of an agreement 
reached during an alternative dispute resolution (ADR) mediation 
session conducted on December 6, 2007.

II

    An investigation was initiated by the NRC Office of Investigations 
(OI) on June 1, 2006, at the Baxter facility in Aibonito, Puerto Rico. 
This investigation was initiated, in part, to determine if Baxter 
employees willfully violated NRC requirements related to inspection and 
maintenance activities for the licensed irradiator at the site, as well 
as personnel training and qualifications for two irradiator operators. 
As noted in an NRC letter to Baxter on September 17, 2007, OI 
substantiated, based on the evidence developed during its investigation 
and a related NRC inspection, that certain Baxter employees, including 
a first-level supervisor (superintendent), deliberately violated NRC 
requirements as evidenced by the following: (1) Certain maintenance 
checks/inspections of the irradiator were not conducted at the Baxter 
facility, during the period of December 1, 2003 to April 24, 2006, 
contrary to 10 CFR 36.61(a); (2) the records associated with these 
maintenance checks/inspections were inaccurate contrary to 10 CFR 30.9; 
(3) the annual performance (training) tests for two individuals were 
not performed as required in 2005, contrary to 10 CFR 36.51(d); and, 
(4) the records associated with these two annual performance tests were 
inaccurate, contrary to 10 CFR 30.9. The September 17, 2007 letter 
offered Baxter the opportunity to either attend a Predecisional 
Enforcement Conference or to request use of ADR, to resolve this 
matter. In response to the September 17, 2007 letter, Baxter requested 
the use of ADR to resolve this matter with the NRC.
    On December 6, 2007, the NRC and Baxter met in an ADR session 
mediated by a professional mediator, arranged through Cornell 
University's Institute on Conflict Resolution. ADR is a process in 
which a neutral mediator with no decision-making authority assists the 
parties in reaching an agreement on resolving any differences regarding 
the enforcement action. This Confirmatory Order is issued pursuant to 
the agreement reached during the ADR process.

III

    During that ADR session, a settlement agreement was reached. The 
elements of the settlement agreement consisted of the following:
    A. The NRC and Baxter Healthcare of Puerto Rico (Baxter) agree that 
certain Baxter employees, including a first-level supervisor 
(superintendent), deliberately violated NRC requirements as evidenced 
by the following: (1) Certain maintenance checks/inspections of the 
irradiator were not conducted at the Baxter facility, during the period 
December 1, 2003 to April 24, 2006, contrary to 10 CFR 36.61(a); and, 
(2) the records associated with these maintenance checks/inspections 
were inaccurate contrary to 10 CFR 30.9;
    B. The NRC maintains that additional deliberate violations of NRC 
requirements occurred in that (1) annual performance (training) tests 
for two individuals were not performed as required in 2005, contrary to 
10 CFR 36.51(d); and, (2) the records associated with these two annual 
performance tests were inaccurate, contrary to 10 CFR 30.9. Baxter 
maintains that based on their investigation of these issues that the 
evidence available to Baxter did not show that these violations 
occurred. The NRC and Baxter agree to disagree relative to these 
violations of 10 CFR 36.51(d) and associated record requirements;
    C. Baxter took multiple corrective actions to address the 
violations, as documented in Baxter's letters dated November 30, 2007, 
February 2, 2007, November 20, 2006, and November 3, 2006, including: 
(1) Revising appropriate procedures to require a second person for 
implementation of the maintenance checks/inspections, as well as a 
second signature to verify completion; (2) revising procedure records 
to include attaching the

[[Page 12778]]

computer printout from the console's Programmable Logic Computer to 
confirm that certain event checks were conducted; (3) training all 
irradiator operators on good documentation practices; (4) completing 
annual performance tests and written tests for all irradiator operators 
in November 2006; (5) conducting two independent reviews of the 
irradiator's operation; (6) interviewing all irradiator operators to 
determine whether similar issues have occurred of which Baxter is not 
aware; (7) training all irradiator operators on the methods to report 
inappropriate behavior; (8) in consultation with the irradiator 
manufacturer, reviewing monthly and weekly maintenance inspection tests 
to affirm the need and frequency of the tests, and to explore methods 
to make the tests less cumbersome; (9) taking appropriate disciplinary 
action against the responsible individuals, commensurate with their 
actions; (10) Plant General Manager attending monthly management 
meetings that discuss identified concerns; (11) implementing the 
``Dupont STOP'' peer observation and feedback process to focus on 
behavior change to improve safety; and, (12) implementing the ``Toyota 
5S'' process, adding a 6th S for Safety to improve facility performance 
and safety;
    D. During the ADR mediation session, Baxter recognized an 
opportunity for additional corrective actions to address the work 
environment concerns that were described in the NRC letter dated 
September 17, 2007. Therefore, Baxter agreed to take the following 
actions to sensitize the gamma sterilization department managers, 
supervisors, and employees to the importance of fostering and 
maintaining a safety culture which encourages all department employees 
to identify safety concerns and inappropriate behavior. These actions 
will consist of:
    1. Using an independent outside organization to conduct a safety 
culture assessment of the gamma sterilization department and include 
any identified recommendations in the Baxter corrective action program. 
This will be completed by June 30, 2008. The results will be 
communicated, as appropriate, to department employees and will be made 
available for NRC review during inspections;
    2. Conducting in-person training of the gamma sterilization 
department employees concerning raising safety issues without fear of 
retaliation, stressing the importance of radiological safety. This will 
be completed by June 30, 2008. Baxter will provide a lesson plan for 
this training activity to the NRC at least 30 days prior to conducting 
the training;
    3. Issuing a lessons-learned letter from the Plant General Manager 
to the gamma sterilization department employees regarding the 
violations described herein, and the underlying causes. This will be 
completed by March 31, 2008; and,
    4. Evaluating annual irradiator operator performance tests to 
ensure that they are consistent with Baxter's commitment to foster a 
safety conscious work environment;
    E. Baxter agreed to send a letter to the NRC, within 30 days of 
completion of all of the actions specified in Items C and D, informing 
the NRC that these actions are complete;
    F. In light of the actions Baxter took as described in Item C, and 
those actions Baxter has committed to take as described in Items D and 
E, as well as Baxter's agreement to pay a $15,000 civil penalty, the 
NRC agreed to characterize the violations as one Severity Level III 
problem with three examples, rather than issuance of separate civil 
penalties for each of the violations. The NRC will issue a letter with 
the aforementioned Notice of Violation, Civil Penalty, and a 
Confirmatory Order to Baxter confirming the commitments set forth 
herein. The letter, the Notice of Violation, Civil Penalty and the 
Confirmatory Order will be publicly available in ADAMS, and will appear 
on the NRC ``Significant Enforcement Actions'' Web site; and
    G. Baxter agreed to the issuance of the letter, the Notice of 
Violation, Civil Penalty, and the Confirmatory Order confirming this 
agreement, and also agrees to waive any request for a hearing regarding 
the aforementioned Confirmatory Order.
    On February 15, 2008, the Licensee, Baxter, consented to issuing 
this Order with the commitments, as described in Section V below. The 
Licensee further agreed that this Order is to be effective upon 
issuance and that it has waived its right to a hearing.

IV

    Since Baxter has agreed to take additional actions to address NRC 
concerns, as set forth in Section III, the NRC has concluded that its 
concerns can be resolved through the NRC's confirmation of the 
commitments as outlined in this Order.
    I find that Baxter's commitments as set forth in Section V 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 public health and safety require that 
the Licensee's commitments be confirmed by this Order. Based on the 
above and Baxter's consent, this Order is immediately effective upon 
issuance.

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 CFR 2.202 and 10 CFR part 30 and 35, it is hereby 
ordered, effective immediately that License No. 52-21175-01 is modified 
as follows:
    A. Baxter will pay a civil penalty in the amount of $15,000 for the 
violation described in the accompanying NOV. The method of payment is 
described in the letter transmitting this Order, as well as in NUREG/
BR-0254;
    B. Baxter will use an independent outside organization to conduct a 
safety culture assessment of the gamma sterilization department and 
include any identified recommendations in the Baxter corrective action 
program. This will be completed by June 30, 2008. The results will be 
communicated, as appropriate, to department employees and will be made 
available for NRC review during inspections;
    C. Baxter will conduct in-person training of the gamma 
sterilization department employees concerning raising safety issues 
without fear of retaliation, stressing the importance of radiological 
safety. This will be completed by June 30, 2008. Baxter will provide a 
lesson plan for this training activity to the NRC at least 30 days 
prior to conducting the training;
    D. Baxter will issue a lessons-learned letter from the Plant 
General Manager to the gamma sterilization department employees 
regarding the violations described herein, and the underlying causes. 
This will be completed by March 31, 2008:
    E. Baxter will evaluate annual irradiator operator performance 
tests to ensure that they are consistent with Baxter's commitment to 
foster a safety conscious work environment;
    F. Baxter will send a letter to the NRC, within 30 days of 
completion of all of the actions specified in Sections V.A-E of this 
order, informing the NRC that these actions are complete; and
    G. Baxter will implement the procedures, training, and other 
actions identified in Section III.C of this Order.
    The NRC Region I Regional Administrator may relax or rescind, in 
writing, any of the above conditions upon demonstration by Baxter of 
good cause.

[[Page 12779]]

VI

    Any person adversely affected by this Confirmatory Order, other 
than Baxter, may request a hearing within 20 days of its issuance. 
Where good cause is shown, consideration will be given to extending the 
time to answer or request a hearing. A request for extension of time 
must be directed to the Director, Office of Enforcement, U.S. Nuclear 
Regulatory Commission, and include a statement of good cause for the 
extension.
    A request for a hearing must be filed in accordance with the NRC E-
Filing rule, which the NRC promulgated in August 2007, 72 FR 49139 
(Aug. 28, 2007). The E-Filing process requires participants to submit 
and serve documents over the internet or, in some cases, to mail copies 
on electronic optical storage media. Participants may not submit paper 
copies of their filings unless they seek a waiver in accordance with 
the procedures described below.
    To comply with the procedural requirements associated with E-
Filing, at least five (5) days prior to the filing deadline the 
requestor must contact the Office of the Secretary by e-mail at 
HEARINGDOCKET@NRC.GOV, or by calling (301) 415-1677, to request (1) a 
digital ID certificate, which allows the participant (or its counsel or 
representative) to digitally sign documents and access the E-Submittal 
server for any NRC proceeding in which it is participating; and/or (2) 
creation of an electronic docket for the proceeding (even in instances 
when the requestor (or its counsel or representative) already holds an 
NRC-issued digital ID certificate). Each requestor will need to 
download the Workplace Forms Viewer\TM\ to access the Electronic 
Information Exchange (EIE), a component of the E-Filing system. The 
Workplace Forms Viewer\TM\ is free and is available at https://
www.nrc.gov/site-help/e-submittals/install-viewer.html. Information 
about applying for a digital ID certificate also is available on NRC's 
public Web site at https://www.nrc.gov/site-help/e-submittals/apply-
certificates.html.
    Once a requestor has obtained a digital ID certificate, had a 
docket created, and downloaded the EIE viewer, it can then submit a 
request for a hearing through EIE. Submissions should be in Portable 
Document Format (PDF) in accordance with NRC guidance available on the 
NRC public Web site at https://www.nrc.gov/site-help/e-submittals.html. 
A filing is considered complete at the time the filer submits its 
document through EIE. To be timely, electronic filings must be 
submitted to the EIE system no later than 11:59 p.m. Eastern Time on 
the due date. Upon receipt of a transmission, the E-Filing system time-
stamps the document and sends the submitter an e-mail notice confirming 
receipt of the document. The EIE system also distributes an e-mail 
notice that provides access to the document to the NRC Office of the 
General Counsel and any others who have advised the Office of the 
Secretary that they wish to participate in the proceeding, so that the 
filer need not serve the document on those participants separately. 
Therefore, any others who wish to participate in the proceeding (or 
their counsel or representative) must apply for and receive a digital 
ID certificate before a hearing request is filed so that they may 
obtain access to the document via the E-Filing system.
    A person filing electronically may seek assistance through the 
``Contact Us'' link located on the NRC Web site at https://www.nrc.gov/
site-help/e-submittals.html or by calling the NRC technical help line, 
which is available between 8:30 a.m. and 4:15 p.m., Eastern Time, 
Monday through Friday. The help line number is (800) 397-4209 or 
locally, (301) 415-4737.
    Participants who believe that they have good cause for not 
submitting documents electronically must file a motion, in accordance 
with 10 CFR 2.302(g), with their initial paper filing requesting 
authorization to continue to submit documents in paper format. Such 
filings must be submitted by (1) first-class mail addressed to the 
Office of the Secretary of the Commission, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, Attention: Rulemaking and 
Adjudications Staff; or (2) courier, express mail, or expedited 
delivery service to the Office of the Secretary, Sixteenth Floor, One 
White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, 
Attention: Rulemaking and Adjudications Staff. Participants filing a 
document in this manner are responsible for serving the document on all 
other participants. Filing is considered complete by first-class mail 
as of the time of deposit in the mail, or by courier, express mail, or 
expedited delivery service upon depositing the document with the 
provider of the service.
    Documents submitted in adjudicatory proceedings will appear in 
NRC's electronic hearing docket which is available to the public at 
https://ehd.nrc.gov/EHD_Proceeding/home.asp, unless excluded pursuant 
to an order of the Commission, an Atomic Safety and Licensing Board, or 
a Presiding Officer. Participants are requested not to include personal 
privacy information, such as Social Security numbers, home addresses, 
or home phone numbers in their filings. With respect to copyrighted 
works, except for limited excerpts that serve the purpose of the 
adjudicatory filings and would constitute a Fair Use application, 
Participants are requested not to include copyrighted materials in 
their works.
    If 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) 
and (f).
    In the absence of any request for a hearing, or written approval of 
an extension of time in which to request a hearing, this Order 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 a hearing shall not stay the effective 
date of this order.

    Dated this the 26th day of February 2008.

    For the Nuclear Regulatory Commission.
Marc L. Dapas,
Deputy Regional Administrator.
[FR Doc. E8-4716 Filed 3-7-08; 8:45 am]
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