Information Notice 2001-03, Incident Reporting Requirements for Radiography Licensees
| ML010800026 | |
| Person / Time | |
|---|---|
| Issue date: | 04/06/2001 |
| From: | Cool D Office of Nuclear Material Safety and Safeguards |
| To: | |
| Smith B | |
| References | |
| -RFPFR IN-01-003 | |
| Download: ML010800026 (9) | |
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555 April 6, 2001 NRC INFORMATION NOTICE 2001-03: INCIDENT REPORTING REQUIREMENTS FOR
RADIOGRAPHY LICENSEES
Addressees
All industrial radiography licensees.
Purpose
The U.S. Nuclear Regulatory Commission (NRC) is issuing this Information Notice (IN) to
provide updated guidance on reporting requirements for radiographers. Licensees should
review this information for applicability to their own procedures 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, information
contained in this notice are not new NRC requirements; therefore, no specific action nor written
response is required.
Background:
NRC issued IN 1996-04 on January 10, 1996, to alert licensees to, and inform them of, the
reporting requirements under 10 CFR 34.30. This IN supersedes IN 1996-04. The guidance
provided in Attachment 1 of IN 1996-04 has been revised to reflect the amended requirements
in 10 CFR 34.101 and has been incorporated into this IN as Attachment 1. As with IN 1996-04, it is expected that licensees use this notice as a guide when preparing reports in accordance
with 10 CFR 30.50(b)(2) and 10 CFR 34.101.
Description of Circumstances
Since the issuance of IN 1996-04, NRC has identified several instances where licensees have
failed to notify NRC, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, in accordance with requirements in 10 CFR 30.50(b)(2),
after the occurrence of an unintentional disconnection of the source assembly from the control
cable, and an inability to retract the source assembly to its fully shielded and secured position.
Discussion:
Changes to Reporting Requirements in Part 34
On May 28, 1997, NRC amended the regulations in Part 34. This amendment, in addition to
other changes, modified the reporting requirements and relocated them from 10 CFR 34.30 to
10 CFR 34.101. These reporting requirements can be found on the NRC web page at
http://www.nrc.gov/NRC/CFR/PART034/index.html and, as guidance, questions and answers
concerning these requirements are listed in Attachment 1.
Notification to NRC of Unintentional Source Disconnects and Source Hang-Ups
10 CFR 30.50 contains conditions for notifying the NRC Operations Center of events
immediately and within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. Notifications are then followed by written reports within
30 days. The requirements apply to all licensees whose licenses are issued in accordance with
10 CFR Part 30. The requirement most applicable to radiography licensees is
10 CFR 30.50(b)(2). The text of this requirement can be found on the NRC web page at
http://www.nrc.gov/NRC/CFR/PART030/index.html.
Pursuant to the requirements in 10 CFR 30.50(b)(2), unintentional disconnection of the source
assembly from the control cable and the inability to retract the source assembly to its fully
shielded and secured position (i.e., source disconnects and hang-ups) are examples where
licensees must notify NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. 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. Hang-ups 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.). The notification must be made by
telephone (301-816-5100) to the NRC Operations Center, in accordance with
10 CFR 30.50(c)(1). The text of this requirement can be found on the NRC web page at
http://www.nrc.gov/NRC/CFR/PART030/index.html.
In addition to notifying NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee must also submit a written report to
NRC within 30 days of the occurrence, as required by 10 CFR 30.50(c)(2) and
10 CFR 34.101(a)(1) [source disconnect] or (2) [source hang-up]. One report can satisfy both
of these requirements, but it must include information required by 10 CFR 30.50(c)(2) and
10 CFR 34.101(b). Guidance on the contents of this report and to whom the report should be
sent is contained in Attachment 1.
Reporting such problems to NRC is important because it provides the opportunity for NRC to
verify that the material has been properly secured and has not been released into the public
domain. If notified early, NRC can help ensure that all necessary regulatory actions
are completed.
NRC reviews information submitted in reports to determine if trends or generic safety issues
exist that have the potential to cause a significant safety hazard. If a generic safety issue is identified, those licensees that may be affected will be notified and informed of the proper
actions to reduce or eliminate similar incidents in the future and to protect the health and safety
of occupational workers and the public. Licensee failure to make the required reports hampers
this effort and violates NRC regulations.
Summary:
The radiography reporting requirements discussed above and in Attachment 1 are those most
specific to industrial radiography licensees. NUREG-1556, Vol. 2, Program-Specific Guidance
About Industrial Radiography Licensees, provides a complete listing of reporting requirements, including those contained in 10 CFR Parts 20 and 30, and contains additional guidance. This
NUREG and others can be found on the NRC web page at
http://www.nrc.gov/NRC/NUREGS/indexnum.html.
Any licensee with questions concerning compliance with NRC or Agreement State requirements
related to reporting industrial radiography incidents should contact either NRC Regional
personnel or its corresponding Agreement State for advice. Manufacturers of radiography
equipment may also want to distribute this IN to customers or incorporate this information into
guidance provided to customers. This could help licensees avoid violations of regulatory
requirements and provide valuable information to NRC. Trends or generic issues associated
with the construction or use of radiography equipment can be identified and appropriate actions
can be taken to reduce or eliminate similar incidents in the future.
This IN requires no specific action nor written response. The guidance contained in this IN is
intended to inform licensees of some regulatory reporting requirements that have been
overlooked in the past. This IN is not all inclusive, and licensees should refer to an updated
copy of the Code of Federal Regulations to ensure full compliance. If you have any questions
about this matter, please contact the technical contact listed below, or the appropriate NRC
regional office. This IN and others can be found on the NRC web page at
http://www.nrc.gov/NRC/GENACT/GC/index.html#IN.
/RA/Josephine M Piccone, Acting for
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical contact: Brian W. Smith, NMSS
(301)415-5723 E-mail: bws1@nrc.gov
Attachments:
1. Questions and Answers for Radiography Reporting Requirements
2. List of Recently Issued NMSS Information Notices
3. List of Recently Issued NRC Information Notices identified, those licensees that may be affected will be notified and informed of the proper
actions to reduce or eliminate similar incidents in the future and to protect the health and safety
of occupational workers and the public. Licensee failure to make the required reports hampers
this effort and violates NRC regulations.
Summary:
The radiography reporting requirements discussed above and in Attachments 1 and 2 are those
most specific to industrial radiography licensees. NUREG-1556, Vol. 2, Program-Specific
Guidance About Industrial Radiography Licensees, provides a complete listing of reporting
requirements and contains additional guidance. This NUREG and others can be found on the
NRC web page at http://www.nrc.gov/NRC/NUREGS/indexnum.html.
Any licensee with questions concerning compliance with NRC or Agreement State requirements
related to reporting industrial radiography incidents should contact either NRC Regional
personnel or its corresponding Agreement State for advice. Manufacturers of radiography
equipment may also want to distribute this notice to customers or incorporate this information
into guidance provided to customers. This could result in licensees avoiding violations of
regulatory requirements and providing valuable information to NRC, as trends or generic issues
associated with the construction or use of radiography equipment can be identified and
appropriate actions can be taken to reduce or eliminate similar incidents in the future.
This IN requires no specific action nor written response. If you have any questions about this
matter, please contact the technical contact listed below, or the appropriate NRC regional
office. This IN and others can be found on the NRC web page at
http://www.nrc.gov/NRC/GENACT/GC/index.html#IN.
/RA/Josephine M. Piccone, Acting for
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical contact: Brian W. Smith, NMSS
(301)415-5723 E-mail: bws1@nrc.gov
Attachments:
1. Questions and Answers for Radiography Reporting Requirements
2. Applicable Regulations
3. List of Recently Issued NMSS Information Notices
4. List of Recently Issued NRC Information Notices
G:\smith\radrepreqin2.WPD ML010800026 OFC MSIB NMSS MSIB MSIB IMNS
NAME BSmith EKrausEK* FBrownREZ* JHickeyJWH* DCool/RA/
DATE 3/01/01 2/28/01 3/ 01 /01 3/ 01 /01 3/21/01
OFFICIAL RECORD COPY
- see previous concurrence
Attachment 1 QUESTIONS AND ANSWERS FOR
RADIOGRAPHY REPORTING REQUIREMENTS
1. WHAT INCIDENTS MUST BE REPORTED?
10 CFR 34.101(a), paragraphs (1)-(3), describe the types of events that must be reported to the
U.S. Nuclear Regulatory Commission (NRC) in a written report within 30 days of the
occurrence. These events include: (1) unintentional source disconnects involving a separation
of the source capsule or source assembly from the drive cable; (2) hang-ups 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 (3) the failure of any other component (critical to safe
operation of the device) 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. Hang-ups 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: (1) 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; (2) failure of the guide
tube or controls to connect to the exposure device as intended, or operate properly; (3) failure
of the coupling between the source assembly and the control cable; and (4) failure of source
position indicators to show actual source position. The licensee is responsible for evaluating
events that may be reportable under 10 CFR 34.101(a) and using appropriate judgment as to
whether the event is reportable. If, after evaluation, the licensee is not sure whether to report
the event, we recommend that the licensee make the report to the Commission, according to
10 CFR 34.101, and include the reasons why the licensee is unsure whether the event
is reportable.
As discussed in the body of this Information Notice (IN), the licensee should determine if this
event is also reportable, under 10 CFR 30.50(b)(2), and make the necessary notifications. In
addition, in accordance with 10 CFR 21.21(a), the licensee should consider whether the failure
constitutes an equipment defect that could create a substantial safety hazard. Additional
guidance on compliance with 10 CFR Part 21 is available in IN 91-39, Compliance with 10 CFR
Part 21, Reporting of Defects and Noncompliance.
Attachment 1 2. WHEN AND WHERE SHOULD THE REPORTS BE SENT?
Within 30 days of an event that is determined to be reportable under 10 CFR 34.101(a), two
copies of the report must be submitted to NRC, to the addressees listed in 10 CFR 34.101(a).
The addressees can be found on the NRC web page at
http://www.nrc.gov/NRC/CFR/PART034/index.html. If the event also requires a written report
under 10 CFR 30.50(c)(2), the report must be submitted to NRC to the address included in that
provision, the text of which can be found on the NRC web page at
http://www.nrc.gov/NRC/CFR/PART030/index.html, with a copy to the appropriate NRC
Regional office. NRC Regional office addresses can be found in 10 CFR 30.6(b)(2) or on the
NRC web page at http://www.nrc.gov/NRC/WHATIS/directio.html.
3. WHAT MUST THE REPORTS INCLUDE?
The requirements for what must be included in a report are contained in 10 CFR 34.101(b), and
are detailed below:
ÿ 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.
ÿ 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.
ÿ 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.
Attachment 1 ÿ 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.
ÿ Actions taken to establish normal operations; This includes any action, taken by the
licensee or other persons, after 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 nor
corrective actions after the investigation (see next section).
ÿ Corrective actions taken or planned to prevent recurrence; This includes training
personnel to better detect incidents and better respond during incidents. It also includes
investigations into the causes of the equipment failure, any repairs made on the
equipment, whether such equipment were removed from service, and whether such
equipment were sent for testing. If testing took place, the results from such testing
should be provided.
ÿ 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.
If the report is also being submitted in accordance with 10 CFR 30.50(c)(2), it should also
contain the following:
ÿ The extent of exposure of individuals to radiation or to radioactive materials without
identification of individuals by name. This information can include personnel dosimetry
results, self-reading dosimeter readings, and estimates based on calculations. The
information provided, however, should not contain the individuals names or any
personal privacy information (e.g., social security numbers, phone numbers, dates of
birth, etc.).
Attachment 1 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. An example of this is described in the body of this IN
[i.e., 10 CFR 30.50(c)(2) and 10 CFR 34.101(a)]. As another example,
10 CFR 34.101(b) requires that reports of overexposure, submitted under
10 CFR 20.2203, which involve failure of safety components of radiography equipment, must also include the information specified further in that paragraph (discussed in
Number 2, above). Therefore, the report submitted under 10 CFR 34.101(b) may also
be submitted to meet part or all of the requirements contained in 10 CFR 20.2203.
Reports submitted under regulations other than 10 CFR 34.101 should contain a
statement that the incident is also reportable under 10 CFR 34.101, so that the reports
can be properly cataloged by the Commission.
Attachment 2 LIST OF RECENTLY ISSUED
NMSS INFORMATION NOTICES
_____________________________________________________________________________________
Information Date of
Notice No. Subject Issuance Issued to
_____________________________________________________________________________________
2001-01 The Importance of Accurate 03/26/01 All material licensees.
Inventory Controls to Prevent
the Unauthorized Possession
of Radioactive Material
2000-22 Medical Misadministrations 12/18/00 All medical use licensees
Caused by Human Errors authorized to conduct gamma
Involving Gamma Stereotactic stereotactic radiosurgery
Radiosurgery (GAMMA KNIFE) treatments.
2000-19 Implementation of Human Use 12/05/2000 All medical use licensees.
Research Protocols Involving
U.S. Nuclear Regulatory
Commission Regulated
Materials
2000-18 Substandard Material Supplied 11/29/2000 All 10 CFR Part 50 licensees and
by Chicago Bullet Proof applicants.
Systems All category 1 fuel facilities.
All 10 CFR Part 72 licensees and
applicants.
2000-16 Potential Hazards Due to 10/5/2000 All licensees that process
Volatilization of Radionuclides unsealed byproduct material.
2000-15 Recent Events Resulting in 9/29/2000 All radiography licensees.
Whole Body Exposures
Exceeding Regulatory Limits
2000-12 Potential Degradation of 9/21/2000 All holders of licenses for nuclear
Firefighter Primary Protective power, research, and test
Garments reactors and fuel cycle facilities.
2000-11 Licensee Responsibility for 8/7/2000 All U.S. NRC 10 CFR Part 50 and
Quality Assurance Oversight of Part 72 licensees, and Part 72 Contractor Activities Regarding Certificate of Compliance holders.
Fabrication and Use of Spent
Fuel Storage Cask Systems
Attachment 3 LIST OF RECENTLY ISSUED
NRC INFORMATION NOTICES
_____________________________________________________________________________________
Information Date of
Notice No. Subject Issuance Issued to
______________________________________________________________________________________
2001-02 Summary of Fitness-for-Duty 03/28/01 All holders of operating licenses
Program Performance Reports for nuclear power reactors, and
for Calendar Years 1998 and licensees authorized to possess
1999 or use formula quantities of
strategic special nuclear material
(SSNM) or to transport formula
quantities of SSNM
2001-01 The Importance of Accurate 03/26/01 All material licensees
Inventory Controls to Prevent
the Unauthorized Possession
of Radioactive Material
2000-17, Crack in Weld Area of Reactor 02/28/01 All holders of operating licenses
Supp. 2 Coolant System Hot Leg Piping for nuclear power reactors except
at V.C. Summer those who has ceased operations
and have certified that fuel has
permanently removed from
reactor vessel
2000-22 Medical Misadministrations 12/18/00 All medical use licensees
Caused by Human Errors authorized to conduct gamma
Involving Gamma Stereotactic stereotactic radiosurgery
Radiosurgery (GAMMA KNIFE) treatments
2000-21 Detached Check Valve Disc 12/15/00 All holders of OLs for nuclear
not Detected by Use of power reactors except those who
Acoustic and Magnetic have ceased operations and have
Nonintrusive Test Techniques certified that fuel has been
permanently removed from the
reactor
______________________________________________________________________________________
OL = Operating License
CP = Construction Permit