[Federal Register Volume 73, Number 47 (Monday, March 10, 2008)]
[Notices]
[Pages 12777-12779]
From the Federal Register Online via the Government Publishing 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
[email protected], 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 http://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 http://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 http://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 http://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
http://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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