Information Notice 1996-04, Incident Reporting Requirements for Radiography Licensees
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555 January 10, 1996 NRC INFORMATION NOTICE 96-04: INCIDENT REPORTING REQUIREMENTS FOR
RADIOGRAPHY LICENSEES
Addressees
and manufacturers
All U.S. Nuclear Regulatory Commission radiography licensees
of radiography equipment.
Purpose
to alert thein. to, and
NRC is issuing this Information notice to addressees 10 CFR 34.30. It is expected
inform them of, the reporting requirements under to their
that recipients will review the information for applicability
as appropriate. This includes
facilities and activities and consider actions, radiography licensees or
manufacturers of radiography equipment who advise
10 CFR Part 34. However, potential licensees on the requirements of are not NRC requirements;
suggestions contained in this information notice
response is required.
therefore, no specific action nor written
Description of Circumstances
requirement, under
On January 10, 1990, Part 34 was amended to add a reportinglicensees to report to
10 CFR 34.30, that made it necessary for radiography or the failure of any
NRC, occurrences of source disconnects, source hangups, perform its
safety related radiography equipment component to properlyare not being reported
intended function. NRC is concerned that incidents of this section
either because licensees have not understood the requirements
or because they do not know that such requirements exist.
under this section.
As of January 1995, NRC has received only about 65 reports
audits of radiography
Based on other sources of information -- including in accordance with 10 CFR
equipment manufacturers' records, reports filed radiography licensees and
Part 21 requirements, and unofficial reports from reports of incidents should
equipment suppliers -- NRC believes that manyofmorea radiography equipment
have been received. Specifically, an audit had been a
manufacturer's customer complaint file showed that there the failure of a
substantial number of complaints from radiographers aabout few reports of this type.
locking mechanism. However, NRC has received only reports that NRC has
of failure. In addition, a substantial number of the of NRC radiography
received have been submitted by only a small percentage likely be more evenly
licensees. Such incidences of reportable events would
distributed.
960,1040335a t,
IN 96-04 January 10, 1996 This information notice is intended to alert radiography licensees to the
requirement to report incidents under 10 CFR 34.30, to describe and provide
examples of the types of incidents that must be reported, and to clarify the
information that must be included in a report to satisfy the requirements of
this section. Attachment 1 to this notice lists frequently asked questions
and answers that provide additional guidance on the types of incidents that
must be reported under 10 CFR 34.30, and how and where the reports are to be
made. Licensees may use the attachment and this notice as a guide when
preparing reports in accordance with 10 CFR 34.30. This notice (and
attachment) will also serve to inform manufacturers of radiography equipment
(who advise and assist radiography licensees) of this requirement. This
notice describes only the minimum information that must be reported. However, licensees may include additional information in a report, as necessary, or
appropriate.
NRC uses information from these reports to detect trends or identify generic
issues associated with the construction or use of radiography equipment, and
to take appropriate actions to reduce or eliminate similar incidents in the
future. Licensee failure to make the required reports hampers this effort and
violates NRC regulations.
Discussion
There are about 169 NRC specific licensees authorized to perform radiographic
operations under NRC jurisdiction. The majority of the reports received
during a 5-year period concerned source disconnects or source hangups. In
addition, several reports were received, early in the period, about manual- locking-mechanism failures that were determined to be caused by a
manufacturing defect. The following paragraphs illustrate examples of reports
received, in accordance with 10 CFR 34.30, on these types of incidents. A
number of other reports, on a variety of other failures, were also received.
A disconnect occurs when the source capsule or source assembly becomes
separated from the drive cable and cannot be normally retracted to the fully
shielded position. Approximately half of all the reports received involved
disconnects. The primary causes of the disconnects were reported to have
resulted from wear in the connector, human error, design flaws, or equipment
malfunction or defect caused during manufacture. For example, disconnects
have occurred when the end of the male connector broke off, when the crimp
holding the female connector on the drive cable failed, and when the pigtail
frayed and broke.
A hangup occurs when the entire source assembly remains connected to the drive
cable, but the source cannot be retracted to the fully shielded position
because of resistance in the equipment or an obstruction. All the reported
hangups have occurred either in the guide tube, the S-tube, or at the exposure
S
/ /
IN 96-04 January 10, 1996 were indicated to
device outlet fitting. The majority of the hangups reported indicating human
be caused by human error or wear in the equipment. Reports set-up the
error have included incidents where the radiographer did not the guide tube
exposure jigs properly, which then toppled onto and crushed
radiographer bent the
sufficiently to prevent source retraction, and where the and preventing proper
guide tube around too sharp an angle, crimping the tube have included
source movement. Reports indicating wear in the equipment depleted uranium, causes such as extensive wear in the S-tube and surrounding the resulting
sufficient to cause the source capsule to become stuck in
indention.
reported, the
In the cases where manual-locking-mechanism failures werecaused by an inherent
manufacturer determined that the reported failures were
position, design flaw that allowed the key to be removed when in the unlocked corrected the
or caused the lock to partially malfunction. The manufacturer
of these types of failures have been
design flaw, and no additional reports
received.
guidance on, and
The failures discussed above are intended to provide general incidents that
familiarize radiography licensees with, the typical types ofthis guidance, and
have been reported. Radiography licensees should consider if an
the additional guidance contained in Attachment 1, when determining radiography
that
incident should be reported. It is extremely importantin a timely manner, licensees make the required reports to the Commission that have the
since the reports are used to detect trends or generic issues NRC uses the
potential to cause a significant safety hazard. In addition, course of
information gleaned from the reports to determine the appropriate and to protect
action to reduce or eliminate similar incidents in the future, licensees and the public.
the health and safety of both the radiography
(see Question 3 of
In addition to the information specified in 10 CFR 34.30 contain a contact's
Attachment 1), we strongly suggest that submitted reports
on the report, if
name and phone number, so that NRC personnel may follow upsuch as facsimile
necessary. Information on other means of communication, phone numbers and Internet E-mail addresses, is also helpful.
IN 96-04 January 10, 1996 This information notice requires no specific action nor written response. If
you have any questions about the information in this notice, please contact
the technical contact listed below or the appropriate regional office.
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical contact: Douglas Broaddus, NMSS
301-415-5847 Internet:dab@nrc.gov
Attachments:
1. Questions and Answers for Reporting Requirements in 10 CFR 34.30
2. List of Recently issued NMSS Information Notices
3. List of Recently issued NRC Information Notices
Attachment 1 IN 96-04 January 10, 1996 FREQUENTLY ASKED
QUESTIONS AND ANSWERS FOR REPORTING
REQUIREMENTS IN 10 CFR 34.30
1. WHAT INCIDENTS MUST BE REPORTED?
Section 34.30(a), paragraphs (1)to (3),(a) describe the types of events
that must be reported. These include: source disconnects involving
assembly from the drive
a separation of the source capsule or sourceassembly from being retracted
cable; (b)hangups that prevent the source in this position, as
to the fully shielded position, and to be secured
of any other component of the
designed and intended; and (c)the failure equipment to operate in an
radiography equipment that could cause the not separation of the
unsafe manner. Disconnects would include also only loss of radioactive
source assembly from the drive cable, but of the source capsule from
material from the source capsule, separation
the drive cable along its length.
the source assembly, and separation of. intended travel of the source, Hangups may occur at any point along the
including the S-tube, the outlet fittings, the guide tube, and any
fittings connected to the end of the guide tube (e.g., collimator, end
components to operate
stops, etc.). Examples of the failure ofinother
an unsafe manner, include:
properly, causing the device to operate adequately secure the
(a)failure of the lock or securing mechanism to thereby allowing
source assembly in the fully shielded position,(b) failure of the guide
unintended movement of the source assembly; device as intended, or
tube or controls to connect to the exposure position indicators to show
operate properly; and (c) failure of source for evaluating
actual source position. The licensee is responsible and use appropriate
events that may be reportable under 10 CFR 34.30 If, after evaluation, judgment as to whether the event is reportable.
the event, we recommended
the licensee is not sure whether to reportCommission, according to
that the licensee make the report to the the licensee is unsure whether
10 CFR 34.30, and include the reasons why
the event is reportable.
2. WHEN AND WHERE SHOULD THE REPORTS BE SENT?
be reportable under
Within 30 days of an event that is determinedbe tosubmitted to NRC, to the
10 CFR 34.30, two copies of the report must (a). The addressees are:
addressees listed in 10 CFR 34.30, paragraph
Branch Chief Director
Medical, Academic, and Office for Analysis and Evaluation
Commercial Use Safety Branch of Operational Data
U.S. Nuclear Regulatory Commission U.S. Nuclear Regulatory Commission
Washington, D.C. 20555 Washington, D.C. 20555
Attachment 1 IN 96-04 January 10, 1996 3. WHAT MUST THE REPORTS INCLUDE?
The requirements for what must be included in a report are contained in
10 CFR 34.30, paragraph (b), and are detailed below:
Section 34.30(b)(1) requires that the report contain "A description of
the equipment problem." The description should include the type of
incident (disconnect, hangup, lock failure, etc.) along with an
explanation of how the event occurred. This explanation could include
the number of exposures taken before the incident happened, the
arrangement of the equipment at the time of the incident, and the
environment in which the incident occurred (a roadside trench, an
exposure cell, excessively hot, cold, or humid conditions, etc.). The
report should always include how the incident was noticed. For example, a disconnect may be noticed by a sudden release in tension on the cable
or a high survey meter reading approaching the exposure device.
Section 34.30(b)(2) requires that the report contain the "Cause of each
incident, if known." The licensee should attempt to determine the root
cause of the incident to the best of its ability and describe it in the
report. We are especially interested in why a licensee believes a part
has failed, whether caused by a manufacturing problem, a design flaw, improper use, or insufficient maintenance.
Section 34.30(b)(3) requires that the report contain the "Manufacturer
and model number of equipment involved in the incident." This would
include the source assembly, exposure device, guide tube, control
assembly, and any fittings, placed on the end of the guide tube, that
were involved in the incident. in all cases, information on the camera
and source assembly involved in the incident should be provided. This
section does not require serial numbers of equipment, although a
licensee may include serial number(s) in the report, and in some cases, this information is helpful.
Section 34.30(b)(4) requires that the report contain the "Place, time, and date of the incident." The place should be a complete street
address, if possible. If the site has no address, the licensee should
describe the site to the best of its ability, including the name of the
site, the nearest road to the site, the nearest town or city, and any
other descriptive information that would be useful in identifying the
location of the incident. The time (including a.m. or p.m.) the
incident occurred and the date(s) it occurred on must also be included
in the report. If the description of the incident includes events that
occurred over several days, the date each event occurred should be
clear.
Section 34.30(b)(5) requires that the report contain a description of
the 'Actions taken to establish normal operations." This includes any
- 1_
Attachment 1 IN 96-04 January 10, 1996 following the incident to
action taken by the licensee or other persons include actions like
return to a normal and safe situation. It would posting barriers
attempting to get the equipment to operate properly,source is exposed, and
and maintaining surveillance of the area while a investigation into the
source-retrieval procedures. It does not include the investigation
cause of the incident or corrective actions following
(see next section).
contain a description of
Section 34.30(b)(6) requires that the report prevent recurrence." This
the "Corrective actions taken or planned to detect and respond during
includes training given to personnel to betterinto the cause of the
an incident. It also includes investigation whether the
equipmeut, failure, any repairs made on the equipment, the equipment was sent
equipment was removed from service, and whether
the results from such testing
for testing. If testing was performed, should be provided.
Section 34.30(b)(7) requires that the report contain a description of
incident." This
the Qualifications of personnel involved in the is needed is a
section does not need to be extensive. All that For instance, was the
description of the types of personnel involved. the equipment
radiographer or the radiographer's assistant operatingthe equipment before
when the incident was noticed? Who was operating at any time?
that time? Was the radiation safety officer involved
of the people
Specific names are not required, only the positionspersonnel involved may
involved. However, the field experience of the
be useful information to include.
ANOTHER REGULATION?
4. WHAT IF DETAILS OF THE INCIDENT ARE REPORTABLE UNDER
regulations, all reports
Unless a specific exclusion is contained in the of whether the
regardless
required in the regulations must be submitted, the regulations in
information has been provided in accordance with
situations, one report can be
another separate report. However, in some requirements. For
submitted to multiple addressees to satisfy several
"Reports of overexposure
example, section 34.30, paragraph (c) requiressection 20.2203] which
submitted under section 20.405 [new Part 20, equipment must also
Involve failure of safety components of radiography
(b) of [10 CFR 34.30]."
include the information specified in paragraph may also be
Therefore, the report submitted under section 34.30
contained in
submitted to meet part or all of the requirements other than
section 20.2203. Reports submitted under regulations incident is also
10 CFR 34.30 should contain a statement that the can be properly
reportable under 10 CFR 34.30 so that the reports
cataloged by the Commission.
- -
N
Attachment 2 IN 96-04 January 10, 1996 LIST OF RECENTLY ISSUED
NMSS INFORMATION NOTICES
Information Date of
Notice No. Subject Issuance Issued to
95-58 10 CFR 34.20; Final 12/18/95 Industrial Radiography
Effective Date Licensees.
95-55 Handling Uncontained 12/6/95 All Uranium Recovery
Yellowcake Outside of a Licensees.
Facility Processing Circuit
95-51 Recent Incidents Involving 10/27/95 All material and fuel cycle
Potential Loss of Control licensees.
of Licensed Material
95-50 Safety Defect in Gammamed 10/30/95 All High Dose Rate
12i Bronchial Catheter Afterloader (HDR) Licensees.
Clamping Adapters
95-44 Ensuring Combatible Use of 09/26/95 All Radiography Licensees.
Drive Cables Incorporating
Industrial Nuclear Company
Ball-type Male Connectors
95-39 Brachytherapy Incidents 09/19/95 All U.S. Nuclear Regulatory
Involving Treatment Commission Medical
Planning Errors Licensees.
95-29 Oversight of Design and 06/07/95 All holders of OLs or CPs
and Fabrication Activities for nuclear power reactors.
for Metal Components Used
in Spent Fuel Dry Storage Independent spent fuel
Systems storage installation
designers and fabricators.
95-28 Emplacement of Support 06/05/95 All holders of OLs or CPs
Pads for Spent Fuel Dry for nuclear power reactors
Storage Installations at
Reactor Sites
It
K- .
Attachment 3 IN 96-04 January 10, 1996 LIST OF RECENTLY ISSUED
NRC INFORMATION NOTICES
Information Date of
Notice No. Subject Issuance Issued to
96-03 Main Steam Safety Valve 01/05/96 All holders of OLs or CPs
Setpoint Variation as a for nuclear power reactors
Result of Thermal Effects
96-02 Inoperability of Power- 01/05/96 All holders of OLs or CPs
Operated Relief Valves for PWRs
Masked by Downstream
Indications During Testing
96-01 Potential for High Post- 01/03/96 All holders of OLs or CPs
Accident Closed-Cycle for PWRs
Cooling Water Temperatures
to Disable Equipment
Important to Safety
95-58 10 CFR 34.20; Final 12/18/95 Industrial Radiography
Effective Date Licensees
95-57 Risk Impact Study Regarding 12/18/95 All holders of OLs or CPs
Maintenance During Low-Power for nuclear power reactors.
Operation and Shutdown
95-56 Shielding Deficiency in 12/11/95 All holders of OLs or CPs
Spent Fuel Transfer Canal for nuclear power reactors.
at a Boiling-Water Reactor
95-55 Handling Uncontalned 12/06/95 All Uranium Recovery
Yellowcake Outside of a Licensees.
Facility Processing
Circuit
OL - Operating License
CP - Construction Permit
I~
K11 IN 96-04 January 10, 1996 This information notice requires no specific action nor written response. If
you have any questions about the information in this notice, please contact
the technical contact listed below or the appropriate regional office.
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical contact: Douglas Broaddus, NMSS
301-415-5847 Internet:dab@nrc.gov
Attachments:
1. Questions and Answers for Reporting Requirements in 10 CFIR 34.30
2. List of Recently issued NMSS Information Notices
3. List of Recently issued NRC Information Notices
Coordinated with IMAB (Pat Santiago) and AEOD (Sam Pettijohn)
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DATE 12/21/95 12/22/95 12/20/95 10/10/95 1/L /96 OFFICIAL RECORD COPY
DOCUMENT NAME: 96-04.IN
/
IN 95- December , 1995 In the cases where manual-locking-mechanism failures were reported, the
manufacturer determined that the reported failures were caused by an inherent
design flaw that allowed the key to be removed when in the unlocked position, or
caused the lock to partially malfunction. The manufacturer corrected the design
flaw, and no additional reports of these types of failures have been received.
The failures discussed above are intended to provide general guidance on, and
familiarize radiography licensees with, the typical types of incidents that have
been reported. Radiography licensees should consider this guidance, and the
additional guidance contained in Attachment 1, when determining if an incident
should be reported. It is extremely important that radiography licensees make
the required reports to the Commission in a timely manner, since the reports are
used to detect trends or generic issues that have the potential to cause a
significant safety hazard. In addition, NRC uses the information gleaned from
the reports to determine the appropriate course of action to reduce or eliminate
similar incidents in the future, and to protect the health and safety of both the
radiography licensees and the public.
In addition to the information specified in 10 CFR 34.30 (see question 3 of
Attachment 1), we strongly suggest that submitted reports contain a contact's
name and phone number, so that NRC personnel may follow up on the report, if
necessary. Information on other means of communication, such as facsimile phone
numbers and Internet E-mail addresses, is also helpful.
This information notice requires no specific action nor written response. If you
have any questions about the information in this notice, please contact the
technical contact listed below or the appropriate regional office.
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety and
Safeguards
Technical contact: Douglas Broaddus, NMSS
301-415-5847 Attachments:
1. Questions and Answers for Reporting Requirements in 10 CFR 34.30
2. List of Recently issued NMSS Information Notices
3. List of Recently issued NRC Information Notices
DOCUMENT NAME: IMNS988.DB2 Coordinated with IMAB (Pat Santiago) and AEOD (Sam Pettijohn)
- See previous concurrence 'E' - Copy with attachment/enclosure N'
- No copy
To receive a copy of this document, Indicate In the box: TC = Copy without attachment/anclosur
OFC SCDB* E SCDB* El PMDA* N IMOB* E D: l
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NAME DBroaddus RBaer EKraus KRamsey
l DATE l12/21/95_ 12/22/95 12/20/95 10/10/95 l1/3 /96 OFFICIAL RECORD COPY
-1i
IN 95- December , 1995 The manufacturer determined that the reported Caowa4- eck4fng-meehran+sm failures
were caused by an inherent design flaw that allowed the key to be removed when
in the unlocked position, or caused the lock to partially malfunction. The
manufacturer corrected the design flaw, and no additional reports of these types
of failures have been received.
The failures discussed above are intended to provide general guidance on, and
familiarize radiography licensees with, the typical types of incidents that have
been reported. Radiography licensees should consider this guidance, and the
additional guidance contained in Attachment 1, when determining if an incident
should be reported. It is extremely important that radiography licensees make
the required reports to the Commission in a timely manner, since the reports are
used to detect trends or generic issues that have the potential to cause a
significant safety hazard. In addition, NRC uses the information gleaned from
the reports to determine the appropriate course of action to reduce or eliminate
similar incidents in the future, and to protect the health and safety of both the
radiography licensees and the public.
In addition to the information specified in 10 CFR 34.30 (see question 3 of
Attachment 1), we strongly suggest that submitted reports contain a contact's
name and phone number, so that NRC personnel may follow up on the report, if
necessary. Information on other means of communication, such as facsimile phone
numbers and Internet E-mail addresses, is also helpful.
This information notice requires no specific action nor written response. If you
have any questions about the information in this notice, please contact the
technical contact listed below or the appropriate regional office.
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety and
Safeguards
Technical contact: Douglas Broaddus, NMSS
301-415-5847 Attachments:
1. Questions and Answers for Reporting Requirements in 10 CFR 34.30
2. List of Recently issued NMSS Information Notices
3. List of Recently issued NRC Information Notices
DOCUMENT NAME: IMNS988.DB2 Coordinated with IMAB (Pat Santiago) and AEOD (Sam Pettijohn)
- See previous concurrence
To receive a copy of this document. Indicate In the box: 'C - Copy without attachmentlenclosure FEW- Copy with attachment/enclsure N = No copy
OFC fSCDB lIEl SCDB I PMDA lI IMOB* 8E D:IMNS I
NAME D 35iddus RBd011 E X KRamsey DCool
DATE 12/ //95 12/j.7195 12/20/95 10/10/95 12/ /95 OFFICIAL RECORD COPY
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-i95- October , 1995 The number of reports received to date may not b a Inclusive, in part, because
radiography licensees are not familiar with t types of incidents required to
be reported under 10 CFR 34.30, or are compleely unaware of the requirement to
report. The above descriptions are inte ed to provide guidance to ensure
radiography licensees are familiar with typical types of incidents reported.
In addition, the attached list of ques ions and answers provides additional
guidance on the types of incidents that ust be reported under 10 CFR 34.30, and
how the reports are to be made. It is extremely important that radiography
licensees make the required reports o the Commission in a timely manner as the
reports are used to detect trends generic issues that have the potential to
cause a significant safety hazad. NRC uses the Information gained in the
reports to determine the approprate action to take to reduce or eliminate
similar incidents in the futu , and to protect the health and safety of the
radiography licensees and th public.
In addition to the requir ents outlined above and in the attachment, it is
strongly suggested that ch report contain a contact's name and phone number, so that NRC personnel m y follow-up on the report, if necessary. Information
concerning other meansof communication, such as facsimile phone numbers and
Internet E-mail addr ses, are also helpful.
This information n ice requires no specific action nor written response. Ifyou
have any quest ois about the information in this notice, please contact the
technical contao listed below or the appropriate regional office.
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
i Office of Nuclear Material Safety and
Safeguards
Technical contact: Douglas Broaddus, NMSS
301-415-5847 Attachments:
1. Questions and Answers for Reporting Requirements in 10 CFR 34.30
2. List of Recently issued NMSS Information Notices
3. List of Recently issued NRC Information Notices
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