[Federal Register Volume 77, Number 82 (Friday, April 27, 2012)]
[Pages 25209-25210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-10191]

[[Page 25209]]



[Docket No. 030-10047; NRC-2012-0097]

Environmental Assessment and Finding of No Significant Impact for 
Exemption Request for Franciscan St. Anthony Health--Crown Point, Crown 
Point, IN

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of availability.


FOR FURTHER INFORMATION CONTACT: Cassandra F. Frazier, Senior Licensing 
Reviewer, Materials Licensing Branch, Division of Nuclear Materials 
Safety, Region III Office, U.S. Nuclear Regulatory Commission, Lisle, 
Illinois 60532. Telephone: 630-829-9830; fax number: 630-515-1078; 
email: [email protected].


I. Introduction

    The U.S. Nuclear Regulatory Commission (NRC or the Commission) is 
considering the renewal of Material License No. 13-15933-01 issued to 
Franciscan St. Anthony Health--Crown Point, Crown Point, Indiana. The 
license renewal would include an exemption to Title 10 of the Code of 
Federal Regulations (10 CFR) 35.400, and related rules to permit the 
continued use of brachytherapy sealed sources that do not have an 
approved Sealed Source and Device Registry (SSDR).
    The NRC has determined that the license renewal qualifies for a 
categorical exclusion under 10 CFR 51.22(c)(14) and therefore does not 
require an Environmental Assessment (EA). Issuance of an exemption to 
10 CFR 35.400 is not covered by a categorical exclusion. Therefore, an 
EA of the proposed exemption is required under 10 CFR Part 51. Based on 
the EA, the NRC has concluded that a Finding of No Significant Impact 
(FONSI) is appropriate. The license renewal with the authorization for 
an exemption to 10 CFR 35.400 and related rules will be issued 
following the publication of this Notice.

II. Environmental Assessment

    The proposed action is the issuance of an exemption to NRC rules at 
10 CFR 30.32(g), 35.49 and 35.400 pursuant to 10 CFR 30.11 and 35.19. 
The purpose of the proposed exemption is to authorize the licensee, 
Franciscan St. Anthony Healt---Crown Point, to continue the use of 
brachytherapy sealed sources previously authorized by the NRC, but that 
have not been approved in the Sealed Source and Device (SSD) Registry.
    The licensee was authorized by the NRC on April 8, 1974, to possess 
and use byproduct materials for medical use at its facility in Crown 
Point, Indiana. While reviewing the licensee's license renewal 
application dated October 26, 2010, the NRC staff determined that 
fourteen sealed brachytherapy sources have been in its possession and 
use since September 18, 1986 (25 years), including cesium-137 sealed 
sources, model numbers 1862, 1864 and 1866, manufactured by Radiation 
Therapy Resources, Inc. The cesium-137 sealed sources are not approved 
in the SSD Registry as required by the NRC regulations at 10 CFR 
    Provisions in 10 CFR 35.400(a) require that sealed sources for 
manual brachytherapy medical use must be approved in the SSD Registry. 
The SSD Registry was established in 1989, as a formalized database to 
be used both by the NRC and the Agreement States in order to serve as a 
``clearing house'' for sources and devices that meet the regulatory 
requirements. Under NRC rules at 10 CFR 30.32(g), normally an applicant 
for a specific license to use byproduct material in the form of a 
sealed source or in a device that contains a sealed source must either 
identify the source or device by manufacturer and model number as 
registered in the SSD Registry, or provide the information described in 
10 CFR 32.210(c) (i.e., information necessary to enable a review to 
determine whether the device should be added to the Registry). In this 
case, however, use of the cesium-137 sources predates the SSD Registry. 
Current registration is not possible because the manufacturer of the 
sources, Radiation Therapy Resources, Inc., is no longer in business 
and the licensee does not have sufficient information to permit the 
normally-required SSD Registry review.
    After telephone discussions with the NRC staff, the licensee, in 
letters dated May 3, 2011, and June 16, 2011, submitted a request for 
an exemption to 10 CFR 35.400(a) to possess the cesium-137 sealed 
sources for therapeutic medical use. The licensee stated that continued 
use of the cesium-137 sealed sources would be medically beneficial. 
Specifically, the sealed sources would be used to provide brachytherapy 
procedures to patients with early state of gynecological cancer or to 
give boost dose post external beam therapy without radiating the dose 
to extra normal tissue. The licensee also stated that the cesium-137 
sealed sources have been used for 25 years with no occurrence of a 
medical event. Quarterly inventory checks have been conducted and the 
sources have been accounted for and stored safely and securely between 
the uses. The licensee conducted six-month leak tests on the sealed 
sources as required by the license, with no incidence of a leaking 
    The NRC staff reviewed the licensee's exemption request, 
information pertaining to the structural integrity of the cesium-137 
sources, and historical records on the use of the cesium-137 sealed 
sources. Historical use of the sealed sources, which predates the 
existence of the SSD Registry, has been conducted safely, without 
environmental releases, and there are no indications that the 
structural integrity of the sources would be adversely affected if the 
current type of use continues.
    The NRC staff's review also found that (1) the licensee is 
qualified by sufficient training and experience and has sufficient 
facilities and equipment, with appropriate procedures, to safely use 
and handle the requested quantity of radioactive material in unshielded 
form, and has the necessary financial assurance; and (2) there is 
historical evidence extending to over two decades that the licensee has 
handled this and similar types of sources without incident. Based on 
its findings, the NRC staff concludes that granting the exemption is 
authorized by law, will not endanger life, property, or the common 
defense and security, and is otherwise in the public interest. The NRC 
plans to renew the license with the exemption provided in a special 
license condition that states, ``Notwithstanding the requirements of 10 
CFR 30.32(g), 35.49, and 35.400, the licensee may use Radiation Therapy 
Resources, Inc., Model Nos. 1862, 1864, and 1866 manual brachytherapy 
sources for medical uses authorized under the provisions of 10 CFR 
    The staff consulted with the State of Indiana, and the State had no 
comments on the proposed action.

III. Finding of No Significant Impact

    On the basis of the EA, the NRC has concluded that there are no 
significant environmental impacts from the issuance of the exemption to 
the NRC rules at 10 CFR 30.32(g), 35.49 and 35.400, and has determined 
not to prepare an environmental impact statement.

IV. Further Information

    Documents related to this action, including the proposed exemption 
request and supporting documentation, are available online in the NRC 
Library at http://www.nrc.gov/reading-rm/

[[Page 25210]]

adams.html. From this site, you can access the NRC's Agencywide 
Document Access and Management System (ADAMS), which provides text and 
image files of NRC's public documents. The ADAMS accession numbers for 
the documents related to this notice are:
    (1.) Franciscan St. Anthony Health-Crown Point, Licensee exemption 
request, May 3, 2011, (ML111230830);
    (2.) Franciscan St. Anthony Health-Crown Point, Licensee exemption 
request, June 16, 2011, (ML111801256);
    (3.) Franciscan St. Anthony Health-Crown Point, Licensee Background 
information, (ML111470614); and
    (4.) Franciscan St. Anthony Health-Crown Point, License Number 13-
15933-01, (ML120800176).
    If you do not have access to ADAMS or if there are problems in 
accessing the documents located in ADAMS, contact the NRC Public 
Document Room (PDR) Reference staff at 1-800-397-4209, 301-415-4737 or 
by email to [email protected].
    These documents may also be viewed electronically on the public 
computers located at the NRC's Public Document Room (PDR), O 1 F21, One 
White Flint North, 11555 Rockville Pike, Rockville, MD 20852. The PDR 
reproduction contractor will copy documents for a fee.

    Dated at Lisle, Illinois, this 18th day of April 2012.

    For the Nuclear Regulatory Commission.
Patricia J. Pelke,
Chief, Material Licensing Branch, Division of Nuclear Materials Safety, 
Region III.
[FR Doc. 2012-10191 Filed 4-26-12; 8:45 am]