Information Notice 2010-24, Notice of Possible Source Leakage During Non-Routine Maintenance on a Gammacell 40 Irradiator
| ML102800027 | |
| Person / Time | |
|---|---|
| Issue date: | 11/19/2010 |
| From: | Robert Lewis NRC/FSME/DMSSA/LISD/LB |
| To: | |
| Sepulveda, L. : 301-415-5619 | |
| References | |
| IN-10-024 | |
| Download: ML102800027 (7) | |
ML102800027 UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF FEDERAL AND STATE MATERIALS
AND ENVIRONMENTAL MANAGEMENT PROGRAMS
WASHINGTON, D.C. 20555
November 19, 2010
NRC INFORMATION NOTICE 2010-24: NOTICE OF POSSIBLE SOURCE LEAKAGE
DURING NON-ROUTINE MAINTENANCE ON A
GAMMACELL 40 IRRADIATOR
ADDRESSEES
All academic Type A broad scope licensees; all medical institutions; all self shielded irradiators
less than or equal to 10,000 Curies licensees; all Radiation Control Program Directors and State
Liaison Officers.
PURPOSE
The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice (IN) to alert
addressees of a contamination event that occurred during a non-routine maintenance operation
on a Gammacell 40 blood irradiator. It is expected that recipients will review the information for
applicability to their facilities and consider actions, as appropriate, to avoid similar incidents.
However, the suggestions contained in this IN are not new NRC requirements; therefore, no
specific action, or written response is required. The NRC is providing this IN to the Agreement
States for their information and for distribution to their licensees as appropriate.
DESCRIPTION OF CIRCUMSTANCES
The NRC received an event notification from the New York State Department of Health on
November 6, 2009, involving a Gammacell 40 irradiator being serviced for a non-routine security
upgrade. While the manufacturers, Best Theratronics, service technicians were dismantling the
device, one of the technicians noted that one of the two pneumatic source drive mechanisms
was moving noticeably slower. After removing the pneumatic drive assemblies and source drive
rod end caps, and manually moving the source drive rods, the technician noted excessive
resistance to movement and corrosion behind the source retaining ring. The technician noted
that the amount of corrosion found behind the retaining ring was noticeably more than observed
in servicing other units. The technician performed a wipe test to check for removable
contamination on the source drive rods behind the source retaining ring. The result was
removable Cs-137 contamination with an activity of 3.4 KBq (92 nCi) exceeding the leak test
limits on both source drive rods. The contamination was limited to an area close to the source
that is typically not accessed in normal use, routine maintenance, and leak testing.
The manufacturer reassembled the irradiator and the licensee suspended the use of the
irradiator. The Gammacell 40 irradiator contained two Cs-137, Model C-161 Type 8 sources, manufactured at the Oak Ridge National Laboratory (ORNL) with an original activity of 132 TBq
(3582 Ci) on November 11, 1975. The New York State Department of Health has issued a notice to its licensees, dated
November 23, 2009, regarding this event. It is attached for your reference. Best Theratronics
issued a safety bulletin to its customers dated December 2, 2009. Please contact the
manufacturer through their website at http://www.theratronics.com or at 866-792-8598 if you
wish to obtain a copy.
DISCUSSION
The Gammacell 40 manufacturer was advised of the situation and followed-up by inspecting
four other units that were scheduled for preventive maintenance. No contamination exceeding
the acceptable limits was found. The contamination in this case may have been caused by
leaching of the source over an extended period of time (15-20 years), as opposed to
contamination which can occasionally occur as a result of the manufacturing process (i.e. hot
cell manipulation and/or welding).
In this case, the source may have been leaching, as opposed to be leaking, because the
radioactive material apparently diffused through the surface of the source encapsulation and
there is no evidence of cracks or damage on the structure or weld. A source is considered to be
leaking source if the radioactive material is coming out of the source encapsulation from the
inside through a crack or damage to the source surface or weld. Leaching was also observed
on a Cs-137 source, Model RAMCO 50, which was removed from a Gammacell 1000 irradiator.
However, the provisions of 10 CFR 34.27(d) require that the observance of 185 Bq (0.005 µCi)
or more of radioactive material must be considered evidence that the source is leaking
regardless of the physical phenomena. Licensees who encounter such phenomena are
expected to comply with the provisions of 10 CFR 34.27(d).
As described above, the contamination was found by the manufacturer during the performance
of a non-routine task in areas that are usually inaccessible. The NRC believes it is possible that
other licensees may encounter this issue, although NRC is not aware of other incidents. The
NRC has determined that these devices can continue to be used safely, and incidents such as
the one described above do not constitute a hazard to the user and/or general public.
Nevertheless, the NRC is distributing this IN for awareness, and recommends that licensees
limit non-routine maintenance on these devices to qualified persons. It is also recommended
that licensees contact the manufacturer for guidance if dismantling work is planned. Licensees
should also ensure that all routine maintenance operations (e.g., wipe tests) are done in
accordance with standard operating procedures and all radiation safety precautions, and ensure
that any contamination found above the 185 Bq (0.005 µCi) limit is reported to the NRC in
accordance with 10 CFR 34.27(d).
CONTACT
S
This IN requires no specific action or written response. If you have any questions about the
information in this notice, please contact one of the technical contacts listed below or the
appropriate regional office.
/RA/
Robert J. Lewis, Director
Division of Materials Safety
and State Agreements
Office of Federal and State Materials
and Environmental Programs
Technical Contacts: Lymari Sepulveda; FSME
(301) 415-5619
E-mail: Lymari.Sepulveda@nrc.gov
John Jankovich; FSME
(301) 415-7904
E-mail: John.Jankovich@nrc.gov
Enclosures:
1. New York State Department of Health
Notice, November 23, 2009
2. List of Recently Issued FSME Generic
Communications
CONTACT
S
This IN requires no specific action or written response. If you have any questions about the
information in this notice, please contact one of the technical contacts listed below or the
appropriate regional office.
/RA/
Robert J. Lewis, Director
Division of Materials Safety
and State Agreements
Office of Federal and State Materials
and Environmental Programs
Technical Contacts: Lymari Sepulveda; FSME
(301) 415-5619
E-mail: Lymari.Sepulveda@nrc.gov
John Jankovich; FSME
(301) 415-7904
E-mail: John.Jankovich@nrc.gov
Enclosures:
1. New York State Department of Health
Notice, November 23, 2009
2. List of Recently Issued FSME Generic
Communications
ML102800027 OFC
MSSA/LB
MSSA/LB
MSSA/RMSB
NAME
LSepulveda: sxg6 JJankovich
AMcIntosh
DATE
08/ 26 /10
08/ 26 /10
08/ 27 /10
OFC
MSSA/LB
MSSA
NAME
JFoster
RJLewis
DATE
08/ 26 /10
11/19/10
OFFICIAL RECORD COPY
IN 2010-24 Enclosure 1 New York State Department of Health Notice
IN 2010-24 Enclosure 2 List of Recently Issued Office of Federal and State Material
and Environmental Management Programs Generic Communications
Date
GC No.
Subject
Addressees
11/13/09 IN-2009-27
Revised International Nuclear and
Radiological Event Scale Users Manual
All holders of an operating license or construction
permit for a power reactor, test reactor or research
reactor issued under 10 CFR Part 50; holders of or
applicants for an early site permit, standard design
certification, standard design approval, manufacturing license, or combined license issued
under 10 CFR Part 52; holders of a materials license, certificate, approval, or registration issued under 10
CFR Parts 30, 31 through 36, 39, 40, 61, 70, 71, 72, and 76; Agreement State Radiation Control Program
Directors and State Liaison Officers.
11/06/09 IN-2009-30
Findings from the NRC Initiative to Assess
Materials Licensees Compliance with the
NRC Decommissioning Requirements
All U.S. Nuclear Regulatory Commission materials
licensees. All Agreement State Radiation Control
Program Directors and State Liaison Officers.
12/03/09 RIS-2009-15 National Source Tracking System Annual
Inventory Reconciliation
All licensees possessing Category 1 or Category 2 quantities of radioactive materials. All
Radiation Control Program Directors and State
Liaison Officers.
01/21/10
RIS-2010-02 The Global Threat Reduction Initiative (GTRI)
Federally Funded Voluntary Security
Enhancements for High-Risk Radiological
Material
All holders of operating licenses for nuclear power
reactors and research and test reactors
under the provisions of Title 10 of the Code of
Federal Regulations (10 CFR) Part 50, Domestic
Licensing of Production and Utilization Facilities, except those that have ceased operations and
have certified that fuel has been permanently
removed from the reactor vessel and have no
spent fuel stored on-site. All U.S. Nuclear Regulatory
Commission (NRC) fuel cycle facilities licensed under
10 CFR Part 40, Domestic Licensing of Source
Material or 10 CFR Part 70, Domestic Licensing of
Special Nuclear Material and gaseous diffusion
plants certified under 10 CFR Part 76, Certification of Gaseous Diffusion Plants.
All holders of site-specific licenses for independent
spent fuel storage installations (ISFSIs) under the
provisions of 10 CFR Part 72, Licensing
Requirements for the Independent Storage
of Spent Nuclear Fuel, High-level Radioactive Waste, and Reactor-related Greater than Class C Waste, and all holders of 10 CFR Part 50 licenses with ISFSIs
under the general license provisions of 10 CFR Part
72. All NRC materials licensees authorized to possess
Category 1 or Category 2 quantities of radioactive
materials, under the provisions of 10 CFR Parts 30,
Rules of General Applicability to Domestic Licensing
of Byproduct Material, 40, and 70.
IN 2010-24 Enclosure 2 List of Recently Issued Office of Federal and State Material
and Environmental Management Programs Generic Communications
Date
GC No.
Subject
Addressees
05/25/10
Monitoring the Status of Regulated Activities
During a Pandemic
All holders of operating licenses for nuclear power
reactors and research and test reactors under the
provisions of Title 10 of the Code of Federal
Regulations (10 CFR) Part 50, Domestic Licensing of
Production and Utilization Facilities, except those
that have ceased operations and have certified that
fuel has been permanently removed from the
reactor vessel and have no spent fuel stored on-site.
All U.S. Nuclear Regulatory Commission (NRC) fuel
cycle facilities licensed under 10 CFR Part 40,
Domestic Licensing of Source Material or 10 CFR
Part 70, Domestic Licensing of Special Nuclear
Material and gaseous diffusion plants certified
under 10 CFR Part 76, Certification of Gaseous
Diffusion Plants. All holders of site-specific licenses
for independent spent fuel storage installations
(ISFSIs) under the provisions of 10 CFR Part 72, Licensing Requirements for the Independent
Storage of Spent Nuclear Fuel, High-level Radioactive
Waste, and Reactor-related Greater than Class C
Waste, and all holders of 10 CFR Part 50 licenses
with ISFSIs under the general license provisions of 10
CFR Part 72. All NRC materials licensees authorized
to possess Category 1 or Category 2 quantities of
radioactive materials, under the provisions of 10 CFR
Parts 30, Rules of General Applicability to Domestic
Licensing of Byproduct Material, 40, and 70.
Note: This list contains the six most recently issued generic communications, issued by the Office of Federal and State Materials and
Environmental Management Programs (FSME). A full listing of all generic communications may be viewed at the NRC public website at the
following address: http://www.nrc.gov/reading-rm/doc-collections/gen-comm/index.html