[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]


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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.

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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