[Federal Register Volume 83, Number 2 (Wednesday, January 3, 2018)]
[Notices]
[Pages 401-404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28331]
=======================================================================
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[Docket No. 30-4675; NRC-2017-0221]
Department of Health and Human Services, Food and Drug
Administration, Winchester Engineering and Analytical Center
AGENCY: Nuclear Regulatory Commission.
ACTION: License amendment application; opportunity to provide comments,
request a hearing and to petition for leave to intervene.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has received a
license amendment application from the Department of Health and Human
Services, Food and Drug Administration (FDA) for the Winchester
Engineering and Analytical Center located in Winchester, MA. The
license authorizes the use of radioactive byproduct material for
research and development. The licensee is requesting a partial site
release for construction of a new 3-story building directly behind the
existing main lab building.
DATES: Submit comments by February 2, 2018. Comments received after
this date will be considered if it is practical to do so, but the
Commission is able to ensure consideration only for comments received
before this date. A request for a hearing or petition for leave to
intervene must be filed by March 5, 2018.
ADDRESSES: You may submit comments by any of the following methods:
Federal Rulemaking website: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0221. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: [email protected]. For technical questions, contact
the individual listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
Mail comments to: May Ma, Office of Administration, Mail
Stop: OWFN-2-A13, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001.
For additional direction on obtaining information and submitting
comments, see ``Obtaining Information and Submitting Comments'' in the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Stephen Hammann, Division of Nuclear
Materials Safety, Region I, U.S. Nuclear Regulatory Commission, 2100
Renaissance Boulevard, Suite 100, King of Prussia, Pennsylvania 19406;
[[Page 402]]
telephone: 610-337-5399; fax number: 610-337-5269; email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2017-0221 when contacting the NRC
about the availability of information for this action. You may obtain
publicly-available information related to this action by any of the
following methods:
Federal Rulemaking website: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0221.
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
Decommissioning Plan is available in ADAMS under Accession No.
ML17215A952.
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.
B. Submitting Comments
Please include Docket ID NRC-2017-0221 in your comment submission.
The NRC cautions you not to include identifying or contact
information that you do not want to be publicly disclosed in your
comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into
ADAMS. The NRC does not routinely edit comment submissions to remove
identifying or contact information.
If you are requesting or aggregating comments from other persons
for submission to the NRC, then you should inform those persons not to
include identifying or contact information that they do not want to be
publicly disclosed in their comment submission. Your request should
state that the NRC does not routinely edit comment submissions to
remove such information before making the comment submissions available
to the public or entering the comment into ADAMS.
II. Introduction
The NRC has received, by letters dated November 25, 2016, (ADAMS
Accession No. ML16347A523) and July 21, 2017, (ADAMS Accession Nos.
ML17215A952 and ML17215A953) an application to amend Materials License
No. 20-08361-01 and a decommissioning plan, respectively. The amendment
provides for a partial site release. The decommissioning plan includes
the radiological survey and subsequent excavation, decontamination, and
proper disposal of licensed radioactive material identified within a
designated area of the site. Specifically, the approval of the
decommissioning plan would allow FDA to begin remediation activities in
the specified area of the Winchester Engineering and Analytical Center
to confirm that the specified area would meet the requirements for
release for unrestricted use as specified in section 14.02 of title 10
of the Code of Federal Regulations (10 CFR). Materials License No. 20-
08361-01 currently authorizes use of radioactive material for research
and development as defined in 10 CFR 30.4 and 10 CFR 70.4.
An NRC administrative completeness review found the application
acceptable for a technical review (ADAMS Accession No. ML17215A953).
Prior to approving the proposed action, the NRC will need to make the
findings required by the Atomic Energy Act of 1954 as amended (the
Act), and the NRC's regulations. The NRC's findings will be documented
in a safety evaluation report and an environmental assessment. The
environmental assessment will be the subject of a subsequent notice in
the Federal Register.
III. Notice and Solicitation of Comments
In accordance with 10 CFR 20.1405, the Commission is providing
notice and soliciting comments from local and State governments in the
vicinity of the site and any Federally-recognized Indian Tribe that
could be affected by the decommissioning. This notice and solicitation
of comments is published pursuant to Sec. 20.1405, which provides for
publication in the Federal Register and in a forum, such as local
newspapers, letters to State or local organizations, or other
appropriate forum, that is readily accessible to individuals in the
vicinity of the site. Comments should be provided within 30 days of the
date of this notice.
IV. Opportunity To Request a Hearing and Petition for Leave To
Intervene
Within 60 days after the date of publication of this notice, any
persons (petitioner) whose interest may be affected by this action may
file a request for a hearing and petition for leave to intervene
(petition) with respect to the action. Petitions shall be filed in
accordance with the Commission's ``Agency Rules of Practice and
Procedure'' in 10 CFR part 2. Interested persons should consult a
current copy of 10 CFR 2.309. The NRC's regulations are accessible
electronically from the NRC Library on the NRC's website at http://www.nrc.gov/reading-rm/doc-collections/cfr/. Alternatively, a copy of
the regulations is available at the NRC's Public Document Room, located
at One White Flint North, Room O1-F21, 11555 Rockville Pike (first
floor), Rockville, Maryland 20852. If a petition is filed, the
Commission or a presiding officer will rule on the petition and, if
appropriate, a notice of a hearing will be issued.
As required by 10 CFR 2.309(d) the petition should specifically
explain the reasons why intervention should be permitted with
particular reference to the following general requirements for
standing: (1) The name, address, and telephone number of the
petitioner; (2) the nature of the petitioner's right under the Act to
be made a party to the proceeding; (3) the nature and extent of the
petitioner's property, financial, or other interest in the proceeding;
and (4) the possible effect of any decision or order which may be
entered in the proceeding on the petitioner's interest.
In accordance with 10 CFR 2.309(f), the petition must also set
forth the specific contentions which the petitioner seeks to have
litigated in the proceeding. Each contention must consist of a specific
statement of the issue of law or fact to be raised or controverted. In
addition, the petitioner must provide a brief explanation of the bases
for the contention and a concise statement of the alleged facts or
expert opinion which support the contention and on which the petitioner
intends to rely in proving the contention at the hearing. The
petitioner must also provide references to the specific sources and
documents on which the petitioner intends to rely to support its
position on the issue. The petition must include sufficient information
to show that a genuine dispute exists with the applicant or licensee on
a material issue of law or fact. Contentions must be limited to matters
within the scope of the proceeding. The contention must be one which,
if proven, would entitle the
[[Page 403]]
petitioner to relief. A petitioner who fails to satisfy the
requirements at 10 CFR 2.309(f) with respect to at least one contention
will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding,
subject to any limitations in the order granting leave to intervene.
Parties have the opportunity to participate fully in the conduct of the
hearing with respect to resolution of that party's admitted
contentions, including the opportunity to present evidence, consistent
with the NRC's regulations, policies, and procedures.
Petitions must be filed no later than 60 days from the date of
publication of this notice. Petitions and motions for leave to file new
or amended contentions that are filed after the deadline will not be
entertained absent a determination by the presiding officer that the
filing demonstrates good cause by satisfying the three factors in 10
CFR 2.309(c)(1)(i) through (iii). The petition must be filed in
accordance with the filing instructions in the ``Electronic Submissions
(E-Filing)'' section of this document.
A State, local governmental body, Federally-recognized Indian
Tribe, or agency thereof, may submit a petition to the Commission to
participate as a party under 10 CFR 2.309(h)(1). The petition should
state the nature and extent of the petitioner's interest in the
proceeding. The petition should be submitted to the Commission no later
than 60 days from the date of publication of this notice. The petition
must be filed in accordance with the filing instructions in the
``Electronic Submissions (E-Filing)'' section of this document, and
should meet the requirements for petitions set forth in this section.
Alternatively, a State, local governmental body, Federally-recognized
Indian Tribe, or agency thereof may participate as a non-party under 10
CFR 2.315(c).
If a hearing is granted, any person who is not a party to the
proceeding and is not affiliated with or represented by a party may, at
the discretion of the presiding officer, be permitted to make a limited
appearance pursuant to the provisions of 10 CFR 2.315(a). A person
making a limited appearance may make an oral or written statement of
his or her position on the issues but may not otherwise participate in
the proceeding. A limited appearance may be made at any session of the
hearing or at any prehearing conference, subject to the limits and
conditions as may be imposed by the presiding officer. Details
regarding the opportunity to make a limited appearance will be provided
by the presiding officer if such sessions are scheduled.
V. Electronic Submissions (E-Filing).
All documents filed in NRC adjudicatory proceedings, including a
request for hearing and petition for leave to intervene (petition), 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 that request to
participate 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. Detailed
guidance on making electronic submissions may be found in the Guidance
for Electronic Submissions to the NRC and on the NRC website at http://www.nrc.gov/site-help/e-submittals.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 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 website 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 website at http://www.nrc.gov/site-help/electronic-sub-ref-mat.html. A filing is considered complete at the
time the document is 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 website 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 6 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
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 Secretary, 11555
Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and
Adjudications Staff. Participants filing adjudicatory documents 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
[[Page 404]]
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 personal 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.
Dated at King of Prussia, Pennsylvania, this 17th day of
November 2017.
For the Nuclear Regulatory Commission.
Raymond J. Powell,
Chief, Decommissioning, ISFSI, and Reactor Health Physics Branch,
Division of Nuclear Materials Safety, Region I.
[FR Doc. 2017-28331 Filed 1-2-18; 8:45 am]
BILLING CODE 7590-01-P