[Federal Register Volume 82, Number 127 (Wednesday, July 5, 2017)]
[Notices]
[Pages 31087-31089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14069]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[Docket No. 03036194; EA-16-255; NRC-2017-0155]
In the Matter of Somascan Incorporated
AGENCY: Nuclear Regulatory Commission.
ACTION: Imposition order; issuance.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing an
Imposition Order to Somascan Incorporated, imposing a civil penalty of
$7,000. On April 5, 2017, the NRC issued a Notice of Violation and
Proposed Imposition of Civil Penalty--$7,000 to Somascan Incorporated,
for failing to comply with regulatory requirements regarding the
decommissioning of its site and securing the licensed material that is
stored in an unrestricted area.
DATES: The Imposition Order was issued on June 27, 2017.
ADDRESSES: Please refer to Docket ID NRC-2017-0155 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-2017-0155. 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 is available
in ADAMS) is provided the first time that it is mentioned in this
document.
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
attached.
Dated at Rockville, Maryland, this 27th of June, 2017.
For the Nuclear Regulatory Commission.
Patricia K. Holahan,
Director, Office of Enforcement.
UNITED STATES OF AMERICA
NUCLEAR REGULATORY COMMISSION
In the Matter of Somascan Incorporated
San Juan, Puerto Rico
Docket No. 03036194
License No. 52-25617-01 (expired)
EA-16-255
ORDER IMPOSING CIVIL MONETARY PENALTY
I.
Somascan, Inc. (Somascan or the Licensee) is the holder of expired
Materials License No. 52-25617-01 issued by the U.S. Nuclear Regulatory
Commission (NRC or Commission) on April 16, 2003, pursuant to Part 30
of Title 10 of the Code of Federal Regulations (10 CFR). Somascan was a
private outpatient medical licensee authorized to possess and use
radiopharmaceuticals and sealed sources for diagnostic and therapeutic
medical procedures permitted by 10 CFR 35.100, 35.200, 35.300, 35.400,
and 35.500; and pre-packaged kits authorized by 10 CFR 31.11.
II.
Onsite inspections of Somascan's activities were conducted between
December 10, 2014 and November 16, 2016. The results of these
inspections
[[Page 31088]]
indicated that Somascan had not conducted its activities in full
compliance with NRC requirements, in that Somascan has neither begun
nor completed decommissioning within the timeframes required by NRC
regulations in 10 CFR 30.36(d) and 30.36(h) or secured from
unauthorized removal or access licensed material that is stored in an
unrestricted area. As a result, on April 5, 2017, a written Notice of
Violation and Proposed Imposition of Civil Penalty (Notice) was issued
to Somascan (ADAMS Accession No. ML17094A537). The Notice states the
nature of the violations, the provisions of the NRC's requirements that
Somascan violated, and the amount of the civil penalty proposed for the
violations. As of the date of this Order, Somascan has not responded to
the Notice.
III.
The NRC staff has determined that the violations occurred as stated
and that the penalty proposed for the violations designated in the
Notice should be imposed. In reaching this determination, the NRC staff
considered that Somascan allowed its license to expire on April 30,
2013, and was previously informed that an expired license precluded
Somascan from performing any licensed activities except those required
for securing licensed radioactive material and decommissioning.
Additionally, Somascan was informed of the need to properly dispose of
its radioactive material and to request termination of its license. To
date, Somascan has not acknowledged the Notice and has not taken any
action to address the violations.
IV.
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 $7,000
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, Somascan 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.
V.
In accordance with 10 CFR 2.205(d), Somascan 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 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 (hereinafter
``petition''), 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, 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. Detailed
guidance on making electronic submissions may be found in the Guidance
for Electronic Submissions to the NRC and on the NRC's Web site at
http://www.nrc.gov/site-help/esubmittals.html. 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 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 submissions and access the
E-Filing system for any proceeding in which it is participating; and
(2) advise the Secretary that the participant will be submitting a
petition or other adjudicatory document (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. Once a participant has obtained a
digital ID certificate and a docket has been created, the participant
can then submit adjudicatory documents. Submissions must 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 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
document on those participants separately. Therefore, applicants and
other participants (or their counsel or representative) must apply for
and receive a digital ID certificate before adjudicatory documents are
filed so that they can obtain access to the documents via the E-Filing
system.
A person filing electronically using the NRC's adjudicatory E-
Filing system may seek assistance by contacting the NRC's 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 to 1-866-672-
7640. The NRC Electronic Filing Help Desk is available between 9 a.m.
and 6 p.m., Eastern Time, Monday through Friday, excluding government
holidays.
Participants who believe that they have 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
expedited delivery service to the Office of the
[[Page 31089]]
Secretary, 11555 Rockville Pike, Rockville, Maryland, 20852, Attention:
Rulemaking and Adjudications Staff. Participants filing adjudicatory
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
https://adams.nrc.gov/ehd/, unless excluded pursuant to an Order of the
Commission or the presiding officer. If you do not have an NRC-issued
digital ID certificate as described above, click ``Cancel'' when the
link requests certificates and you will be automatically directed to
the NRC's electronic hearing dockets where you will be able to access
any publicly available documents in a particular hearing docket.
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. For example, in some instances,
individuals provide home addresses in order to demonstrate proximity to
a facility or site. 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.
If a person other than Somascan 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 Somascan
or a person whose interest is adversely affected, the Commission will
issue an Order designating the time and place of any hearings. If a
hearing is held, the issue to be considered at such hearing shall be
whether this Order should be sustained.
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 27th day of June 2017.
For the Nuclear Regulatory Commission.
Patricia K. Holahan,
Director, Office of Enforcement.
[FR Doc. 2017-14069 Filed 7-3-17; 8:45 am]
BILLING CODE 7590-01-P