[Federal Register Volume 75, Number 19 (Friday, January 29, 2010)]
[Notices]
[Pages 4879-4881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-1824]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[IA-09-041]
Juan E. P[eacute]rez Mont[eacute], M.D.; Confirmatory Order
Modifying License (Effective Immediately)
I
Juan E. P[eacute]rez Mont[eacute], M.D. (Dr. P[eacute]rez) is named
as the Radiation Safety Officer (RSO) on License No. 52-25542-01 issued
by the NRC to Beta Gamma Nuclear Radiology (BGNR), a medical practice
in Fajardo, Puerto Rico.
This Confirmatory Order is the result of an agreement reached
during an alternative dispute resolution (ADR) mediation session
conducted on October 27, 2009. 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
dispute.
II
On July 2, 2009, the U.S. Nuclear Regulatory Commission (NRC or
Commission) issued a letter to Dr. P[eacute]rez, enclosing a summary of
an investigation conducted by the NRC Office of Investigations (OI)
(Reference OI Investigation Report No. 1-2008-052). OI opened the
investigation to determine whether Beta Gamma Nuclear Radiology (BGNR)
had submitted falsified written directives in a May 5, 2008, response
to a April 8, 2008, Severity Level (SL) IV Notice of Violation (NOV).
The SLIV NOV had been issued for BGNR's failure to prepare written
directives prior to administering diagnostic doses of radioactive
iodine on the dates of September 14, 2005, and February 19 and 26,
2008. In its May 5, 2008, response, BGNR disputed the SLIV NOV in a
sworn and notarized letter stating that Dr. P[eacute]rez, as the
Authorized User, had in fact prepared written directives for the I-131
sodium iodide administrations prior to conducting them on September 14,
2005, and February 19 and 26, 2008, and that although the written
directives had been misplaced, since the inspection, the written
directives had been located. The letter enclosed copies of these
written directives. During review of the letter, the NRC identified
that the written directive for the administrations performed on
September 14, 2005, was dated September 14, 2008, calling into question
the validity of the date on which this directive, and the others, had
been written.
Based on evidence developed during the investigation, the NRC
identified an apparent violation, including that Dr. P[eacute]rez, on
behalf of BGNR, deliberately submitted falsified written directives in
violation of 10 CFR 30.10(a)(2), and as a result, caused BGNR to
maintain inaccurate information contrary to 10 CFR 30.9, in violation
of 10 CFR 30.10(a)(1).
The July 2, 2009, NRC letter informed Dr. P[eacute]rez that the NRC
was considering escalated enforcement for the apparent violation. On
July 6, 2009, Dr. P[eacute]rez requested the use of an ADR mediation
session to resolve this matter. On October 27, 2009, the NRC and Dr.
P[eacute]rez met in an ADR session mediated by a professional mediator,
arranged through
[[Page 4880]]
Cornell University's Institute on Conflict Resolution. This
Confirmatory Order is issued pursuant to the agreement reached during
the ADR process.
III
During that ADR session, a preliminary settlement agreement was
reached. The elements of the agreement consisted of the following:
A. Dr. P[eacute]rez and the NRC agree that Dr. P[eacute]rez
committed two violations of NRC requirements. Specifically, Dr.
P[eacute]rez: (1) Deliberately submitted falsified written directives
to support BGNR's dispute of the April 8, 2008, NOV in violation of 10
CFR 30.10(a)(2); and, (2) deliberately caused BGNR to maintain
incomplete or inaccurate information as required by 10 CFR 30.9, in
violation of 10 CFR 30.10(a)(1).
B. Dr. P[eacute]rez will write an article regarding: (1) Lessons
learned from the ADR experience; (2) the importance of providing
accurate information to the NRC; and, (3) compliance with NRC
requirements; and will complete the following actions:
1. Within six months of the date of the Order, Dr. P[eacute]rez
will submit the article for publication to the following: Galenus
(Puerto Rico), the Journal of the Health Physics Society, and the
Journal of Nuclear Medicine; and,
2. Dr. P[eacute]rez will also submit the article to the NRC for
approval, at least two weeks prior to submitting to the publications
listed above.
C. Dr. P[eacute]rez will write a presentation regarding: (1)
Lessons learned from the ADR experience; (2) the importance of
providing accurate information to the NRC; and, (3) compliance with NRC
requirements. Dr. P[eacute]rez will submit to the NRC the planned
presentation for approval at least two weeks before delivering the
actual presentation to the Puerto Rico chapter of the Society of
Nuclear Medicine.
D. Dr. P[eacute]rez will offer to make the same or a similar
presentation at the next scheduled national meetings of the Health
Physics Society and the Society of Nuclear Medicine. If the request to
make a presentation is accepted, he will submit the planned
presentation to the NRC for approval at least two weeks before delivery
of the presentation at these meetings.
E. Dr. P[eacute]rez will remove himself as RSO from any NRC or
Agreement State licenses within 30 days of Order issuance, and will not
be re-designated or perform the functions of RSO for any NRC or
Agreement State license for two years from the date of Order issuance.
In recognition of these actions, the NRC agreed to not issue Dr.
P[eacute]rez an order prohibiting involvement in NRC-licensed
activities, but rather, to issue a Notice of Violation containing a
Severity Level III violation. On January 12, 2010, Dr. P[eacute]rez
consented to issuing this Order with the commitments, as described in
Section V below. Dr. P[eacute]rez further agreed that this Order is to
be effective upon issuance and that he has waived his right to a
hearing.
IV
Since Dr. P[eacute]rez 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 issuance of this
Order.
I find that Dr. P[eacute]rez' 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
Dr. P[eacute]rez' commitments be confirmed by this Order. Based on the
above and Dr. P[eacute]rez' 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, it is hereby ordered,
effective immediately:
A. Dr. P[eacute]rez will write an article regarding: (1) Lessons
learned from the ADR experience; (2) the importance of providing
accurate information to the NRC; and, (3) compliance with NRC
requirements; and will complete the following actions:
1. Within six months of the date of the Order, Dr. P[eacute]rez
will submit the article for publication to the following: Galenus
(Puerto Rico), the Journal of the Health Physics Society, and the
Journal of Nuclear Medicine; and,
2. Dr. P[eacute]rez will also submit the article to the NRC for
approval, at least two weeks prior to submitting to the publications
listed above.
B. Prior to the next scheduled national meetings of the Health
Physics Society and the Society of Nuclear Medicine, Dr. P[eacute]rez
will write a presentation regarding: (1) Lessons learned from the ADR
experience; (2) the importance of providing accurate information to the
NRC; and, (3) compliance with NRC requirements. Dr. P[eacute]rez will
submit to the NRC the planned presentation for approval at least two
weeks before delivering the actual presentation to the Puerto Rico
chapter of the Society of Nuclear Medicine.
C. Dr. P[eacute]rez will offer to make the same or a similar
presentation at the next scheduled national meetings of the Health
Physics Society and the Society of Nuclear Medicine. If the request to
make a presentation is accepted, he will submit the planned
presentation to the NRC for approval at least two weeks before delivery
of the presentation at these meetings.
D. Dr. P[eacute]rez will be removed as RSO from any NRC or
Agreement State licenses within 30 days of Order issuance, and will not
be re-designated or perform the functions of RSO for any NRC or
Agreement State licenses for two years from the date of Order issuance.
The Director, Office of Enforcement, may, in writing, relax or
rescind any of the above conditions upon demonstration by the Licensee
of good cause.
VI
Any person adversely affected by this Confirmatory Order, other
than Dr. P[eacute]rez, may request a hearing within 20 days of its
publication in the Federal Register. 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 directed to the Director,
Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington,
DC 20555-0001, and include a statement of good cause for the extension.
All documents filed in NRC adjudicatory proceedings, including a
request for hearing, a petition for leave to intervene, any motion or
other document filed in the proceeding prior to the submission of a
request for hearing or petition to intervene, and documents filed by
interested governmental entities participating under 10 CFR 2.315(c),
must be filed in accordance with the NRC E-Filing rule (72 FR 49139,
August 28, 2007). The E-Filing process requires participants to submit
and serve all adjudicatory documents over the Internet, or in some
cases to mail copies on electronic storage media. Participants may not
submit paper copies of their filings unless they seek an exemption in
accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least
ten (10) days prior to the filing deadline, the participant should
contact the Office of the Secretary by e-mail at
[email protected], or by telephone at (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
[[Page 4881]]
server for any proceeding in which it is participating; and (2) advise
the Secretary that the participant will be submitting a request or
petition for hearing (even in instances in which the participant, or
its counsel or representative, already holds an NRC-issued digital ID
certificate). Based upon this information, the Secretary will establish
an electronic docket for the hearing in this proceeding if the
Secretary has not already established an electronic docket.
Information about applying for a digital ID certificate is
available on NRC's public Web site at http://www.nrc.gov/site-help/e-submittals/apply-certificates.html. System requirements for accessing
the E-Submittal server are detailed in NRC's ``Guidance for Electronic
Submission,'' which is available on the agency's public Web site at
http://www.nrc.gov/site-help/e-submittals.html. Participants may
attempt to use other software not listed on the Web site, but should
note that the NRC's E-Filing system does not support unlisted software,
and the NRC Meta System Help Desk will not be able to offer assistance
in using unlisted software.
If a participant is electronically submitting a document to the NRC
in accordance with the E-Filing rule, the participant must file the
document using the NRC's online, Web-based submission form. In order to
serve documents through EIE, users will be required to install a Web
browser plug-in from the NRC Web site. Further information on the Web-
based submission form, including the installation of the Web browser
plug-in, is available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals.html.
Once a participant has obtained a digital ID certificate and a
docket has been created, the participant can then submit a request for
hearing or petition for leave to intervene. 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
documents are submitted through the NRC's E-Filing system. To be
timely, an electronic filing must be submitted to the E-Filing 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
E-Filing 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
documents on those participants separately. Therefore, applicants and
other participants (or their counsel or representative) must apply for
and receive a digital ID certificate before a hearing request/petition
to intervene is filed so that they can obtain access to the document
via the E-Filing system.
A person filing electronically using the agency's adjudicatory E-
Filing system may seek assistance by contacting the NRC Meta System
Help Desk through the ``Contact Us'' link located on the NRC Web site
at http://www.nrc.gov/site-help/e-submittals.html, by e-mail at
[email protected], or by a toll-free call at (866) 672-7640. The
NRC Meta System Help Desk is available between 8 a.m. and 8 p.m.,
Eastern Time, Monday through Friday, excluding government holidays.
Participants who believe that they have a good cause for not
submitting documents electronically must file an exemption request, 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. A presiding officer, having
granted an exemption request from using E-Filing, may require a
participant or party to use E-Filing if the presiding officer
subsequently determines that the reason for granting the exemption from
use of E-Filing no longer exists.
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, or the 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, unless an NRC regulation or other law requires submission of
such information. 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 submission.
Any person that requests a hearing 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).
If the 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 should be
sustained. In the absence of any request for hearing, or written
approval of an extension of time in which to request a hearing, the
provisions specified in Section V above 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 V shall be final when the extension
expires if a hearing request has not been received. A request for
hearing shall not stay the immediate effectiveness of this order.
Dated this 21st day of January 2010.
For the Nuclear Regulatory Commission.
Marc L. Dapas,
Deputy Regional Administrator.
[FR Doc. 2010-1824 Filed 1-28-10; 8:45 am]
BILLING CODE 7590-01-P