Protecting People and the EnvironmentUNITED STATES NUCLEAR REGULATORY COMMISSION
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
All U.S. Nuclear Regulatory Commission radiography licensees and manufacturers
of radiography equipment.
Purpose
NRC is issuing this information notice to addressees to alert them to, and
inform them of, the reporting requirements under 10 CFR 34.30. It is expected
that recipients will review the information for applicability to their
facilities and activities and consider actions, as appropriate. This includes
manufacturers of radiography equipment who advise radiography licensees or
potential licensees on the requirements of 10 CFR Part 34. However,
suggestions contained in this information notice are not NRC requirements;
therefore, no specific action nor written response is required.
Description of Circumstances
On January 10, 1990, Part 34 was amended to add a reporting requirement, under
10 CFR 34.30, that made it necessary for radiography licensees to report to
NRC, occurrences of source disconnects, source hangups, or the failure of any
safety related radiography equipment component to properly perform its
intended function. NRC is concerned that incidents are not being reported
either because licensees have not understood the requirements of this section
or because they do not know that such requirements exist.
As of January 1995, NRC has received only about 65 reports under this section.
Based on other sources of information -- including audits of radiography
equipment manufacturersþ records, reports filed in accordance with 10 CFR
Part 21 requirements, and unofficial reports from radiography licensees and
equipment suppliers -- NRC believes that many more reports of incidents should
have been received. Specifically, an audit of a radiography equipment
manufacturerþs customer complaint file showed that there had been a
substantial number of complaints from radiographers about the failure of a
locking mechanism. However, NRC has received only a few reports of this type
of failure. In addition, a substantial number of the reports that NRC has
received have been submitted by only a small percentage of NRC radiography
licensees. Such incidences of reportable events would likely be more evenly
distributed.
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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
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device outlet fitting. The majority of the hangups reported were indicated to
be caused by human error or wear in the equipment. Reports indicating human
error have included incidents where the radiographer did not set up the
exposure jigs properly, which then toppled onto and crushed the guide tube
sufficiently to prevent source retraction, and where the radiographer bent the
guide tube around too sharp an angle, crimping the tube and preventing proper
source movement. Reports indicating wear in the equipment have included
causes such as extensive wear in the S-tube and surrounding depleted uranium,
sufficient to cause the source capsule to become stuck in the resulting
indention.
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 contactþs
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.
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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
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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), describe the types of events
that must be reported. These include: (a) source disconnects involving
a separation of the source capsule or source assembly from the drive
cable; (b) hangups that prevent the source assembly from being retracted
to the fully shielded position, and to be secured in this position, as
designed and intended; and (c) the failure of any other component of the
radiography equipment that could cause the equipment to operate in an
unsafe manner. Disconnects would include not only separation of the
source assembly from the drive cable, but also loss of radioactive
material from the source capsule, separation of the source capsule from
the source assembly, and separation of the drive cable along its length.
Hangups may occur at any point along the intended travel of the source,
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
stops, etc.). Examples of the failure of other components to operate
properly, causing the device to operate in an unsafe manner, include:
(a) failure of the lock or securing mechanism to adequately secure the
source assembly in the fully shielded position, thereby allowing
unintended movement of the source assembly; (b) failure of the guide
tube or controls to connect to the exposure device as intended, or
operate properly; and (c) failure of source position indicators to show
actual source position. The licensee is responsible for evaluating
events that may be reportable under 10 CFR 34.30 and use appropriate
judgment as to whether the event is reportable. If, after evaluation,
the licensee is not sure whether to report the event, we recommended
that the licensee make the report to the Commission, according to
10 CFR 34.30, and include the reasons why the licensee is unsure whether
the event is reportable.
2. WHEN AND WHERE SHOULD THE REPORTS BE SENT?
Within 30 days of an event that is determined to be reportable under
10 CFR 34.30, two copies of the report must be submitted to NRC, to the
addressees listed in 10 CFR 34.30, paragraph (a). The addressees are:
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
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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 . Attachment 1
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action taken by the licensee or other persons following the incident to
return to a normal and safe situation. It would include actions like
attempting to get the equipment to operate properly, posting barriers
and maintaining surveillance of the area while a source is exposed, and
source-retrieval procedures. It does not include investigation into the
cause of the incident or corrective actions following the investigation
(see next section).
Section 34.30(b)(6) requires that the report contain a description of
the "Corrective actions taken or planned to prevent recurrence." This
includes training given to personnel to better detect and respond during
an incident. It also includes investigation into the cause of the
equipment failure, any repairs made on the equipment, whether the
equipment was removed from service, and whether the equipment was sent
for testing. If testing was performed, the results from such testing
should be provided.
Section 34.30(b)(7) requires that the report contain a description of
the "Qualifications of personnel involved in the incident." This
section does not need to be extensive. All that is needed is a
description of the types of personnel involved. For instance, was the
radiographer or the radiographer's assistant operating the equipment
when the incident was noticed? Who was operating the equipment before
that time? Was the radiation safety officer involved at any time?
Specific names are not required, only the positions of the people
involved. However, the field experience of the personnel involved may
be useful information to include.
4. WHAT IF DETAILS OF THE INCIDENT ARE REPORTABLE UNDER ANOTHER REGULATION?
Unless a specific exclusion is contained in the regulations, all reports
required in the regulations must be submitted, regardless of whether the
information has been provided in accordance with the regulations in
another separate report. However, in some situations, one report can be
submitted to multiple addressees to satisfy several requirements. For
example, section 34.30, paragraph (c) requires þReports of overexposure
submitted under section 20.405 [new Part 20, section 20.2203] which
involve failure of safety components of radiography equipment must also
include the information specified in paragraph (b) of [10 CFR 34.30].þ
Therefore, the report submitted under section 34.30 may also be
submitted to meet part or all of the requirements contained in
section 20.2203. Reports submitted under regulations other than
10 CFR 34.30 should contain a statement that the incident is also
reportable under 10 CFR 34.30 so that the reports can be properly
cataloged by the Commission.
