Information Notice 2001-03, Incident Reporting Requirements for Radiography Licensees

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