[Federal Register Volume 81, Number 227 (Friday, November 25, 2016)]
[Pages 85274-85276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28374]



[Docket Nos. 030-37882 and 030-37957; EA-16-055 NRC-2016-0242]

In the Matter of International Cyclotron

AGENCY: Nuclear Regulatory Commission.

ACTION: Imposition order; issuance.


SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing an 
Imposition Order to International Cyclotron, imposing a civil penalty 
of $14,000. On August 30, 2016, the NRC issued a Notice of Violation 
and Proposed Imposition of Civil Penalty--$14,000 to International 
Cyclotron, for failing to comply with regulatory requirements regarding 
the decommissioning of its site.

DATES: The Imposition Order was issued on November 17, 2016.

ADDRESSES: Please refer to Docket ID NRC-2016-0242 when contacting the 
NRC about the availability of information regarding this document. You 
may obtain publicly-available information related to this document 
using any of the following methods:
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2016-0242. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: [email protected]. For questions about this 
Imposition Order, contact the individual listed in the FOR FURTHER 
INFORMATION CONTACT section of this document.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may obtain publicly-available documents online in the 
ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``ADAMS Public Documents'' and 
then select ``Begin Web-based ADAMS Search.'' For problems with ADAMS, 
please contact the NRC's Public Document Room (PDR) reference staff at 
1-800-397-4209, 301-415-4737, or by email to [email protected]. The 
ADAMS accession number for each document referenced (if it available in 
ADAMS) is provided the first time that a document is referenced.
     NRC's PDR: You may examine and purchase copies of public 
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 
Rockville Pike, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT: Leelavathi Sreenivas, Office of 
Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001; telephone: 301-287-9249, email: [email protected].

SUPPLEMENTARY INFORMATION: The text of the Imposition Order is 

    Dated at Rockville, Maryland, this 17th of November, 2016.
    For the Nuclear Regulatory Commission.
Patricia K. Holahan,
Director, Office of Enforcement.

United States of America

Nuclear Regulatory Commission

In the Matter of International Cyclotron, Inc.

Hato Rey, Puerto Rico

Docket Nos. 03037882 and 03037957

License Nos. 52-31352-01MD and 52-31352-02EA-16-055

Order Imposing Civil Monetary Penalty


    International Cyclotron, Inc. (International Cyclotron or the 
Licensee) is the holder of Materials License Nos. 52-31352-01MD and 52-
31352-02 issued by the U.S. Nuclear Regulatory Commission (NRC or 
Commission) on August 20, 2009, pursuant to Part 30 of Title 10 of the 
Code of Federal Regulations (10 CFR). The licenses authorized the 
Licensee to prepare and distribute fluorine-18 (F-18) 
radiopharmaceuticals for Positron Emission Tomography (PET) imaging 
studies and to operate a cyclotron which was used to produce the F-18, 
in accordance with the conditions specified therein. These activities 
were not regulated by the NRC until the Energy Policy Act of 2005 
(EPAct) expanded the definition of byproduct material to include 
naturally occurring and accelerator-produced radioactive material 
(NARM), including the use of certain cyclotron activities and 
radioactive materials produced in cyclotrons for commercial purposes.
    In a December 7, 2009, letter (ADAMS Accession No. ML093430005), 
the NRC informed the Licensee that in accordance with 10 CFR 
30.35(b)(1), it was required to provide financial assurance and a 
decommissioning funding plan for the quantities of unsealed byproduct 
materials with half-lives greater than 120 days that International 
Cyclotron was authorized to possess under License No. 52-31352-02. 
Although the Licensee submitted an acceptable decommissioning funding 
plan with a decommissioning cost estimate on October 14, 2011 (non-
public due to proprietary, financial information contained therein), 
the Licensee did not provide a financial assurance instrument. As a 
result, on December 19, 2011, the NRC issued a letter with a Notice of 
Violation (ADAMS Accession No. ML11347A256) and an Order (ADAMS 
Accession No. ML11353A417) requiring International Cyclotron to provide 
financial assurance within 60 days or to shut down operations of the 
cyclotron and the radiopharmacy. On February 17, 2012, when no 
financial assurance was provided to the NRC by International Cyclotron, 
the Order became effective, and International Cyclotron ceased 
operations. In a letter dated March 22, 2014 (ADAMS Accession No. 
ML14093A157), the Licensee provided written notification that 
International Cyclotron would begin decommissioning as soon as 
possible, but before April 18, 2014.


    The NRC has continued to communicate with International Cyclotron 
by letter, telephone, and email, and has met with the Licensee on 
multiple occasions, including two site inspections and multiple site 
visits, to ascertain the status of site decommissioning. The results of 
these reviews indicated that the Licensee had not conducted its 
activities in full compliance with NRC requirements, in that 
International Cyclotron has neither begun nor completed decommissioning 
within the timeframes required by NRC regulations in 10 CFR 30.36(d). A 
written Notice of Violation and Proposed Imposition of Civil Penalty 
(Notice) was served upon the Licensee by letter dated August 30, 2016

[[Page 85275]]

(ADAMS Accession No. ML16238A071). The Notice states the nature of the 
violation, the provisions of the NRC's requirements that the Licensee 
violated, and the amount of the civil penalty proposed for the 
    In a letter dated September 13, 2016 (ADAMS Accession No. 
ML16266A337), a representative of the Licensee stated that his firm was 
assisting International Cyclotron with establishing a financial 
assurance instrument and with arranging for another company to operate 
or purchase the cyclotron. The Licensee representative stated that, 
with more time, an arrangement could be made.


    After consideration of the letter from the Licensee's 
representative and the statements contained therein, the NRC staff has 
determined that the violation occurred as stated and that the penalty 
proposed for the violation designated in the Notice should be imposed. 
In reaching this determination, the NRC staff considered that the 
Licensee was informed of the requirement to obtain financial assurance 
nearly seven years ago, was issued the Order to cease operations more 
than four years ago, and was required to complete decommissioning of 
its site by April 18, 2016. During this timeframe, the Licensee has 
repeatedly informed the NRC that it was working to obtain financial 
assurance and was seeking to find an operator/buyer for the facility. 
However, neither of these actions have occurred and the Licensee has, 
to date, taken no actions towards site decommissioning.


    In view of the foregoing and pursuant to Section 234 of the Atomic 
Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205, 
it is hereby ordered that:
    The Licensee shall pay a civil penalty in the amount of $14,000 
within 30 days of the issuance date of this Order, in accordance with 
NUREG/BR-0254, ``Payment Methods'' (see http://www.nrc.gov/reading-rm/doc-collections/nuregs/brochures/br0254/). In addition, at the time 
payment is made, the Licensee shall submit a statement indicating when 
and by what method payment was made, to the Director, Office of 
Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 
11555 Rockville Pike, Rockville, MD 20852-2738.


    In accordance with 10 CFR 2.205(d), International Cyclotron and any 
other person adversely affected by this Order may request a hearing on 
this Order within 30 days of the issuance date of this Order. 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 
    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 (hereinafter 
``petition''), and documents filed by interested governmental entities 
participating under 10 CFR 2.315(c), must be filed in accordance with 
the NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended at 77 
FR 46562, August 3, 2012). 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 10 
days prior to the filing deadline, the participant should contact the 
Office of the Secretary by email at [email protected], or by 
telephone at 301-415-1677, to (1) request a digital identification (ID) 
certificate, which allows the participant (or its counsel or 
representative) to digitally sign documents and access the E-Submittal 
server for any proceeding in which it is participating; and (2) advise 
the Secretary that the participant will be submitting a petition (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 the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals/getting-started.html. System requirements for accessing 
the E-Submittal server are available on the NRC's public Web site at 
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 Electronic Filing Help Desk will not be 
able to offer assistance in using unlisted software.
    Once a participant has obtained a digital ID certificate and a 
docket has been created, the participant can then submit a petition. 
Submissions should be in Portable Document Format (PDF). Additional 
guidance on PDF submissions is available on the NRC's public Web site 
at http://www.nrc.gov/site-help/electronic-sub-ref-mat.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 email notice 
confirming receipt of the document. The E-Filing system also 
distributes an email notice that provides access to the document to the 
NRC's 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 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 NRC's adjudicatory E-
Filing system may seek assistance by contacting the NRC Electronic 
Filing Help Desk through the ``Contact Us'' link located on the NRC's 
public Web site at http://www.nrc.gov/site-help/e-submittals.html, by 
email to [email protected], or by a toll-free call at 1-866-672-
7640. The NRC Electronic Filing Help Desk is available between 9 a.m. 
and 7 p.m., Eastern Time, Monday through Friday, excluding government 
    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 
stating why there is good cause for not filing electronically and 
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 

[[Page 85276]]

delivery service to the Office of the Secretary, 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 the 
NRC's electronic hearing docket which is available to the public at 
http://ehd1.nrc.gov/ehd/, 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. 
However, in some instances, a petition will require including 
information on local residence in order to demonstrate a proximity 
assertion of interest in the proceeding. 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.
    The Commission will issue a notice or order granting or denying a 
hearing request or intervention petition, designating the issues for 
any hearing that will be held and designating the Presiding Officer. A 
notice granting a hearing will be published in the Federal Register and 
served on the parties to the hearing.
    If a person other than International Cyclotron 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).
    If a hearing is requested by a licensee or 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 Order should be 
    In the absence of any request for a hearing or alternative dispute 
resolution (ADR), or written approval of an extension of time in which 
to request a hearing or ADR, the provisions specified in Section IV 
above shall be final 30 days from the date of this Order without 
further order or proceedings. If an extension of time for requesting a 
hearing or ADR has been approved, the provisions specified in Section 
IV shall be final when the extension expires if a hearing or ADR 
request has not been received. If ADR is requested, the provisions 
specified in Section IV shall be final upon termination of an ADR 
process that did not result in issuance of an order. If payment has not 
been made by the time specified above, the matter may be referred to 
the Attorney General, for collection.

    Dated at Rockville, Maryland, this 17th of November, 2016.

    For the Nuclear Regulatory Commission.
Patricia K. Holahan,
Director, Office of Enforcement.
[FR Doc. 2016-28374 Filed 11-23-16; 8:45 am]