ML20248D382

Review of Events at Large POOL-TYPE Irradiators

ML20248D382
Person / Time
Issue date:	03/31/1989
From:	Trager E NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
To:
References
TASK-AE, TASK-S807 AEOD-S807, NUREG-1345, NUDOCS 8904110450
Download: ML20248D382 (64)

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NUREG-1345 Review of Events at Large Pool-Type Irradiators U.S. Nuclear Regulatory Commission Office for Analysis and Evaluation of Operational Data E. A. Trager, Jr.

n#42A888 "o 2

1345 R PDR 4

a.

AVAILABILITY f40TICE Availability of Reference Materials Cited in NRC Publications Most documents cited in NRC publications will be available from one of the following sources:

1.

The NRC Public Document Room, 2120 L Street, NW, Lower Level, Washington, DC 20555

-2.

The Superintendent of Documents, U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20013-7082 3.

The National Technical Information Service, Springfield, VA 22161 Although the listing that follows represents the majority of documents cited in NRC publica-tions, it is not intended to be exhaustive.

Referenced documents available for inspect'on and copying for a fee from the NRC Public Document Room include NRC correspondence and internal NRC memoranda; NRC Office of Inspection and Enforcement bulletins, circulars, information notices, inspection and investi-l gation notices: Licensee Event Reports; vendor reports and correspondence; Commission papers; and applicant and licensee documents bnd correspondence.

The following documents in the NUREG series are available for purchase from the GPO Sales Program: formal NRC staff and contractor reports, NRC-sponsored conference proceed-ings, and NRC booklets and brochures. Also available are Regulatory Guides, NRC regula-tions in the Code of Federal Regulations, and Nuclear Regulatory Commission issuances.

Documents available from the National TechnicalInformation Service includa NUREG series reports and technical reports prepared by other federal agencies and reports prepared by the Atomic Energy Commission, forerunner agency to the Nuclear Regulatory Commission.

Documents available from public and special technical l!.>raries include all open literature items, such as books, journal and periodical articles, and transactions. Federal Register notices, federal and state legislation, and congressional reports can usually be obtained i

from these !!Draries.

Documents such as theses, dissertations, foreign reports and translations, and non-NRC conference proceedings are available for purchase from the organization sponsoring the publication cited.

Single copies of NRC draft reports are available free, to the extent of supply, upon written request to the Office of information Resources Management, Distribution Section, U.S.

Nuclear Regulatory Commission, Washington, DC 20555.

Copies of industry codes and standards used in a substantive manner in the NRC regulatory process are maintained at the NRC Library,7920 Norfolk Avenue, Bethesda, Maryland, and are available there for reference use by the public. Codes and standards are usually copy-righted and may be purchased from the originating organization or, if they.are American National Standards,. frorn the American National Standards Institute,1430' Broadway, New York, NY 10018.

1

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NUREG-1345 Review of Events

)

at Large Pool-Type Irradiators l

Manuscript Completed: September 1980 Date Published: March 1989 E.A. Trager, Jr.

l Division of Safety Programs Office for Analysis and Evaluation of Operational Data U.S. Nuclear Regulatory Commission Washington, DC 20566 4

s

TABLE OF CONTENTS P_ag

SUMMARY

I

1.0 INTRODUCTION

I 2.0 LARGE'IRRADIATOR FACILITIES....................................

3 3.0 EVENTS AT LARGE IRRADIATORS.....................................

4 3.1 Personnel Radiation Overexposure 5.2 Improper Functioning of Safety Interlocks 3.2.1 Interlock Defects-

{

3.2.2 Bypassed Interlocks

3. 3 Other Equipment Malfunctions 3.4 Release of Radioactive Material.

4 l

3. 5 Fires 3.6 Management Deficiencies 3.6.1 International Nutronics Incorporated.

i

.(INI), Dover,NJ l

3.6.2 Radiation Technology Incorporated (RTI),

I Rockaway, NJ 3.6.3 Radiation Sterilizers Incorporated (RSI)

~

3.6.4 Precision Materials. Corporation (PMC),

I Mine Hill, NJ 3.6.5

~INI, Palo Alto, CA 3.7 Natural Phenomena 3.8 Summary of Root Causes 4.0 ANALYSIS OF EVENTS AND LESSONS LEARNED........................

18 4.1 Events Stemming from System Problems

-i 4.1.1 Access Control Systems 4.1.2 Source Movement and Suspension 4.1.3 Encapsulation 4.1.4 Pool Leakage and Pool Purification System 4.1.5 Miscellaneous Systems 4.2 Management Deficiencies 4.3 Natural Phenomena and Other Site Problems 5.

FINDINGS.................................-.....................

22 6.

CONCLUSIONS AND RECOMMENDATIONS..............................

23 7.

REFERENCES....................................................

24 APPENDIX A - Notes on Large Pool-type Irradiators Located in the United States.......................... A-1 APPENDIX B - Operating Events Reported at Large Pool-type Irradiators................................ B-1 APPENDIX C - Reporting Requirements of 10 CFR 20.403.............. C-1 i

iii j

-w REVIEW OF EVENTS AT LARGE POOL-TYPE IRRADIATORS l

SUMMARY

Large pool-type gamma irradiators are used in applications such as the " cold" sterilization of medical and pharmaceutical supplies, and recent changes in federal regulations make it possible they will be usod. extensively in the preservation of foodstuffs. Because of this possible large increase in the use of irradiators, the Office of Nuclear Materials Safety and Safeguards was interested in knowing what events had occurred at irradiators. The event data would be used as background in developing new regulations on irradiators.

Therefore, AE0D began a study of the operating experience at large, wet source j

storage gamma irradiators. The scope of the study was to assess all available operating information on large (3 250,000 curie), pool-type irradiators licensed by both the NRC and the Agreement States, and events at foreign facilities.

l l

The study found that about 0.12 events have been reported per irradiator year.

Most of these events were precursor events, in that there was no evidence of damage to the radioactive sources or degradation in the level of safety of the facility.

Events with more significant impacts had a reported frequency of about 0.01 event per irradiator year. However, the actual rate of occurrence of events of concern to the staff may be higher because there are few specific reporting requirements for events at irradiators. We suggest that during development of a regulation for large pool-type irradiators consideration be given to specifying requirements for: reporting breakdowns in access control systems; periodic inspection of the source movement and suspension system; systems to detect source leakage and product contamination; allowable pool leakage; and feedback of information on operational events involving l

safety-important systems (i.e., requiring reporting of specific events).

l

1.0 INTRODUCTION

A panoramic, wet source storage irradiator, (American National Standards Institute ANSI N43.10, category IV), is a " controlled human access irradiator in which the sealed source is contained in a storage pool (usually containing water). The sealed source is fully shielded when not in use, and the sealed source is exposed within a radiation volume that is maintained inaccessible during use by an entry control systet." The sealed sources contain cobalt-60 (Co-60) or cesium-137 (Cs-137).

Since the 1960's, increased use has been made of large, wet source storage irradiators in applications, such as the sterilization of medical and pharmaceutical supplies.

Recent concern over the possibly carcinogenic effects of ethylene oxide residues may make radiation sterilization an even more attractive alternative method of sterilization.

In addition, recent changes in federal regulations make it possible that radiation sterilization will become a popular process for preserving foodstuffs.

An AE00 study of operating experience at large irradiators was made as part of an ef fort to cvaluate whether er not current NRC regulatory requirements concerning large irradiators are adequate.

The study included a review of all available information on large ft 250,000 curie), pool-type irradiators licensed by both the NRC and the Agreement States, and events at foreign facilities. _

~

The focus was on events that have occurred since 1980, because tney are considered inore representative of events that are likely to occur at irradiator facilities today. 1/

{

)

The potential personnel radiation exposui crd posed by the sources at large irradiators is substantial.

For example, tte ashielded dose from a 250,000 Ci Co-60 source is approximately 250,000 rem /hr W9 rem /sec) at 4 feet and approximately 25,000 rem /hr (6.9 rem /sec) at 13 feet.

Therefore, a lethal dose could be received within minutes.

1 The integrity of the Co-60 and Cs-137 sealed sources is important because-the sealed sources are stored in pools of water and a leaking source could j

contaminate the storage pool and perhaps the environment. Hence, the integrity

)

of the storage pool must also be assured.

Section 2 of this report includes a brief description of large irradiator facilities that have been operated recently, and Section'3 includes a i

discussion of events that have occurred at those facilities.

Section 4 includes analyses of the events and the lessens learned.

Sections 5 and 6 contain the findings and conclusions of this study.

1/ In 1978, NRC regulations were changed [10 CFR 20.203(c)(6) was added] to require improved access controls for irradiators (42 FR 64619, dated December 7, 1977). - ___. _ _ _ _ _ _

1 2.0 LARGE IRRADIATOR FACILITIES The radioactive material'used most widely in large pool-type irradiators is Co-60, although a number of facilities have begun to use Cs-137-in Waste Encapsulation Storage Facility (WESF) capsules leased from the Department of Energy (00E). Facilities currently in operation are licensed to possess up to 10 megacuries-(10.0 MCl) Co-60 or 30 megacuries (30.0 mci) Cs-137.

J 8ecause the average energy from CJ-137 decay is roughly one quarter that of Co-60, and because of the source design (the WESF capsule was designed to provide long term containment of material and not to optimize radiation l

distribution), roughly seven times as many curies of Cs-137 are needed to produce the'same dose rate as Co-60. The long half-life of Cs-137 (30 years) compared with that of Co-60 (5 years) makes it easier to maintain a constant curie inventory.

Table 1 lists 48.large irradiator facilities located in the United States, j

Additional information on the facilities is included in Appendix A.

Operations were recently halted at six of the facilities and three of the facilities have not yet begun operations. Fifteen of the 39 currently operating facilities are licensed by the NRC and 24 are licensed by Agreement States. Most of the facilities were designed by Atomic Energy of Canada Limited (AECL) and use Co-60 sources. The 35 facilities using Co-60 are authorized to possess.a total of 108 million curies (mci) Co-60, or an average of about 3.1 mci per facility. The four facilities using Cs-137 are authorized to possess a total of 58.5 mci, or about 14.6 mci per facility. The length of time these irradiators have been operating varies widely. As of December 31, 1987, the average facility had been operating for about 8.6 years; the range q

is from 1.8 to 23.6 years. Half of the facilities now in operation, (20 of 39),

i started operations after 1980.

?

Table 2 lists plant operating experience in recent years for plants that are currently in operation. These data show that the industry has had more operating experience since 1982 (2180 plant years), than all the experience up through 1982.

Table 2 YEARS OF IRRADIATOR OPERATING EXPERIENCE FOR V.S. PLANTS CURRENTLY IN OPERATION-PLANT-YRS.

CUMULATIVE EXPERIENCE YEARS OPERATION (PLANT-YEARS) 1964-1965 4

4 1966-1970 19 23 1971-1975 35 58 1976-1980 74 132 1981 22 154 1982 26 180 1983-31 211 1984 33 244 1985 37 281 1986 39 320 1987 39 359.

c h

3.0 EVENTS AT LARGE IRRADIATORS The~ primary sources of information on events at irradiators were reports of

' events by NRC licensees and inspection reports by the NRC.. The Agreement States indicated that very few problems had been reported at irradiators located in those States.

. {

In addition to the 39'large irradiators operating in the United States (U.S.),

there are many other large irradiators operated around the world.

~In March 1986, there were 132 operating in.39 countries. worldwide. 2/ However, there was little detailed information available on events that occurred outside the United S

'AECL, designer of'the' majority of the plants in operation today, provided information that was available on events'that have occurred at facilities

-designed by AECL.

The following report subsections include'information on the events by event -

type and in chronological order.

Information on foreign events was included when it was available.

Table 3 lists operational events a'tJirradiators in chronological order.

It includes a summary of type of the problem reported, the.cause of the problem, and when it was reported.

Appendix B contains additional-information on these events.

3.1 _ Personnel radiation overexposure.

This is potentially the most serious type of event at a large irradiator because such an overexposure may be' life threatening.

However, changes to the regulations that were made effective in 1978-(10 CFR 20,203(c)(6) requires improved access controls for high radiation areas) appear to have been successful in limiting the occurrence this type'of event.

Two known fatalities have occurred as a result of radiation overexposeres at irradiators: in Italy on May 13, 1975 and in Norway.on September 2, 1982 The incident in Italy occurred at a facility where a 30,000 Ci Co-60 source was being used to irradiate corn.

That irradiator had been in operation for-about three months.

An operator had climbed onto.the conveyor belt to make an adjustment and was moved under the unit while the source was exposed.

When the-operator complained of severe pain in his head, his partner attempted to remove him from beneath the unit.

However,-he ran the conveyor forward rather than in reverse and exposed the victim's entire body to the unshielded source. The victim died 12 days later (ref.1).

than 1000 rad (ref. 2).

.The. absorbed dose was' estimated at greater

-2/ "World List of Industrial Gamma Irradiators," AECL Industrial Irradiation Division, March 1986. _ _ _ - _ _ _

2.0 LARGE.IRRADIATOR' FACILITIES The radioactive material used most widely in large pool-type irradiators is Co-60, although a number of facilities have begun to use Cs-137 in Waste Encapsulation Storage Facility (WESF) capsules leased from the Department of Energy (00E).

Facilities currently in operation are licensed to possess up to 10 megacuries (10.0 mci) Co-60 or 30 megacuries (30.0 mci) Cs-137.

Because the average energy from Cs-137 decay is roughly one quarter that of Co-60, and because of the source design (the WESF capsule was designed to provide long term containment of material and not to optimize radiation distribution), roughly seven times as many curies of Cs-137 are needed to produce the same dose rate as Co-60. The long half-life of Cs-137 (30 years) compared with that of Co-60 (5 years) makes it easier to maintain a constant curie inventory.

Table 1 lists 48 large irradiator facilities located in the United States.

Additional information on the facilities is included in Appendix A.

l Operations were recently halted at six of the facilities and three of the facilities have not yet begun operations.

Fifteen of the 39 currently operating facilities are licensed by the NRC and 24 are licensed by Agreement States. Most of the facilities were designed by Atomic Energy of Canada Limited (AECL) and use Co-60 sources. The 35 facilities using Co-60 are authorized to possess a total of 108 million curies (mci) Co-60, or an average of about 3.1 mci per facility. The four facilities using Cs-137 are authorized to possess a total of 58.5 mci, or about 14.6 mci per facility. The length of time these irradiators have been operating varies widely. As of December 31, 1987, the average facility had been operating for about 8.6 years; the range is from 1.8 to 23.6 years. Half of the facilities now in operation, (20 of 39),

started operations after 1980.

Table 2 lists plant operating experience in recent years for plants that are currently in operation. These data show that the industry has had more operating experience since 1982 (2180 plant years), than all the experience up through 1982.

Table 2 YEARS OF IRRADIATOR OPERATING EXPERIENCE FOR U.S. PLANTS CURRENTLY IN OPERATION PLANT-YRS.

CUMULATIVE EXPERIENCE YEARS OPERATION (PLANT-YEARS) 1964-1965 4

4 1966-1970 19 23 1971-1975 35 58 1976-1980 74 132 1981 22 154 1982 26 180 1983 31 211 1984 33 244 1985 37 281 1986 39 320 4

1987 39 359 1

-?-

l l

)

i

3.0 EVENTS AT LARGE IRRADIATORS The primary sources of information on events at irradiators were reports of events by HRC licensees and inspection reports by the NRC. The Agreement States indicated that very few problems had been reported at irradiators located in those States.

In addition to the 39 large irradiators operating in the United States (U.S.),

there are many other large irradiators operated around the world.

In March 1986, there were 132 operating in 39 countries worldwide. 2/ However, there was little detailed information available on events that occurred outsidc the United States.

AECL, designer of the majority of the plants in operation today, provided information that was available on events that have occurred at facilities designed by AECL.

The following report subsections include information on the events by event-type and in chronological order.

Information on foreign events was included when it was available.

Table 3 lists operational events at irradiators in chronological order.

It includes a summary of type of the problem reported, the cause of the problem, and when it was reported.

Appendix B contains additional information on these events.

3.1 Personnel radiation overexposure.

This is potentially the most serious type of event at a large irradiator because such an overexposure may be life threatening.

However, changes to the regulations that were made effective in improved access controls for high radiation areas) appear to have been1978 (10 CFR 2 successful in limiting the occurrence this type of event.

Two known fatalities have occurred as a result of radiation overexposure at irradiators: in Italy on May 13, 1975 and in Norway on September 2, 1982.

The incident in Italy occurred at a facility where a 30,000 Ci Co-60 source was being used to irradiate corn.

That irradiator had been in operation for about three months.

An operator had climbed onto the conveyor belt to make an adjustment and was moved under the unit while the source was exposed.

When the operator complained of severe pain in his head, his partner attempted to remove him from beneath the unit.

However, he ran the conveyor forward rather than in reverse and exposed the victim's entire body to the unshielded source.

The victim died 12 days later (ref. 1).

The absorbed dose was estimated at greater than 1000 rad (ref. 2).

2/ "World List of Industrial Gamma Irradiators," AECL Industrial Irradiation Division, March 1986.

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4 In Norway at the Institute for Energy Technology, a service technician was exposed to a 65,000 Ci Co-60 source.

The technician died from radiation injury 13 days later.

The irradiator was a conveyor belt,. continuous type, operating 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> a day, and unattended at night.

The conveyor belt jammed at night and the sources failed to automatically retract to the shielded position.

The technician had arrived at work in the morning to find a green indicator light l

(source shielded signal) and an unbarred door interlock, and entered the irradiation room while the source was in the unshielded position. A radiation monitor normally located in the room was out for repair (ref. 3; also, NRC IN 83-09).

An investigation found that the safety interlock system did not fully meet the single failure criterion (that is, a system is designed to withstand a single failure if it continues to function as required following the failure of a single component in the system), although it was required.

The irradiation 1

room door lock was a common component in both the radiation interlock system and the source position interlock system.

In this event., the failure of a single microswitch in the source position' indication system caused a " source shielded" signal to be displayed and released the barring of the door lock.

The radiation monitor that was part of the radiation interlock system was out of service for maintenance. Therefore, when the technician arrived, he saw the

" source shieldad" signal displayed and was able to unlock the door with the operational key because it was not barred.

The earliest reported radiation overexposure occurred on June 13, 1974, at an Isomedix facility formerly operated in Parsippany, New Jersey. Without using normal operating procedures, an operator entered a hot cell with the source e.xposed.

He realized his error and left. He received from 185-400 Rem in 3-10 seconds exposure. While this 3-10 second radiation exposure did not result in a lethal dose, it might have under different circumstances. A number of factors contributed to this event including design deficiencies (the facility in which the event occurred was actually a hot cell and lacked safety features that might have prevented the event), 'and failure to follow procedures.

It is also possible that the worker was not sufficiently vigilant because he was working alone at a late point in his work cycle.

The operator made the error on the twelfth hour of the fourth straight day on which he worked 10 to 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br />. To prevent recurrence, the design was changed to incorporate safety features.

This event appears to have had a significant impact on the future of the industry.

It showed the need for automatic safety systems and the importance of following procedures.

On September 23, 1977, a radiation overexposure occurred at the Radiation Technology Incorporated (RTI) facility in Rockaway, New Jersey, because an operator entered the irradiation chamber following a shift change while the source was unshielded.

This occurred because the facility management had decided to al. low the source to be raised with both interlock and safety devices inoperable. The operator averted a more serious overexposure because he felt a " tingling sensation" after he had worked near the exposed 500,000 curie Co-60 source for about 10 seconds and rapidly left the area (ref. 5).

It was estimated that the employee received a 150-300 Rem whole body dose from this exposure (Abnormal Occurrence 77-10). _ _ _ _ _ - _ _ _ _ _ _

In an event on June 18, 1982, at the facil%ty operated by Isomedix in Parsippany, New Jersey, a film badge indicated an exposure to radiation exceeding the dose limit. Because the overexposure was not supported by the worker's activities nor by medical examination results, the licensee concluded that there was reason to suspect that.the badge had been exposed by an unknown person (ref. 6).

There are a number of important lessons to be learned from these radiation overexposure events. First, irradiator safety systems must be installed that prevent radiation overexposure that might result from human performance problems (for example, simple human error) and must be designed to meet the single failure criterion.

Second, facility personnel must thoroughly understand the equipment being operated and the requirements regarding the safety systems.

Finally, the facility personnel must be aware of the responsibilities under the license and must understand the primary importance of having management that is committed to operating and maintaining the facility in accordance with license requirements.

3.2-Improper functioning of safety interlocks.

Seven events were reported in which interlocks were defective or were bypassed.

Five of these have been reported since 1983.

3.2.1 Interlock Defects The earliest interlock defect condition was identified on January 19, 1978, at the Americ1an Converters facility, when it was discovered that the source rack could move from the shielded to the unshielded position with the failure of two door interlock switches.

This problem was corrected with a wiring modification (ref. 7).

Another interlock defect condition was identified at American Convertors on March 20, 1985. A poor connection in an electrical subsystem of both the master and overdose timers could prevent the timers from _ timing down and lead to static radiation condition which could result in a fire. The components were replaced (ref. 8, 18).

This event was identified in a Part 21 report (ref. 8).

The most recent interlock defect was identified at Ethicon in Somerville, New Jersey, on August 27, 1987.

In that event, a tote jammed which caused a microswitch to short out and the 24 volt AC control circuit to trip. The source then began to move to the shielded position.

However, with the control power out, the source cable drum continued to turn when the source plaque assembly reached the fully shielded (submerged) position and began raising the source by winding the cables on the drum in reverse until the motor stalled when the source assembly reached the full-up position.

The source had to be hand-cranked to the shielded position (ref. 9, 10).

s 4

3.2.2 Bypassed Interlocks Post of the events reported to the NRC in which interlocks were bypassed (3 of 4) took place at the RTI facility in Rockaway, New Jersey.

As was noted in Section 3.1, the September 23, 1977, radiation overexposure at this facility occurred at the time of a management decision to allow the source to be raised with the interlock and safety devices inoperable.

The license was suspended by the NRC from September 23, 1977, to October 14, 1977.

During an inspection on September 21, 1984, an NRC inspector found that the licensee had been operating the irradiator with an inoperable safety interlock.

Because of a problem with switches in the interlock system, the licensee had posted a memo on April 4, 1984, requiring that the conveyor doors be wired open during the automatic mode of operation (ref. 11). On September 26, 1984, the licensee committed to operate the facility only if all safety interlocks were operable, and to cease operations if any safety interlock failed to function. On February 26, 1986, an NRC inspector found the licensee had operated the facility with a malfunctioning radiation monitor (ref. 12).

The fourth case in which interlocks were found to be bypassed occurred at the Isomedix facility in Parsippany, New Jersey.

During a routine inspection on August 19, 1987, NRC inspectors found that the licensee had been operating the walk-in irradiator since May 1987 without the radiation detector that sensed elevated radiation levels. The detector operated a door iriterlock that prevented personnel from entering a high radiation area.

The inspectors also learned that operation without the detector had occurred on previous occasions for shorter periods of time (ref. 13).

l To summarize, several events occurred in which safety systems failed or malfunctioned or were degraded. The failures or malfunctions did not result in problems because other safety systems functioned, and operating procedures were followed, and correction of these problems has resulted in improved systems.

Only a small number of facilities were involved in the reports of events in which interlocks were bypassed.

3.3 Other Equipment Malfunctions Other equipment malfunctions included improper source movement, source plaque problems, cable failures, and conveyor failures.

These are events in which there is the potential for more serious problems if personnel do not respond correctly. These include failures and malfunctions that may have been due to an inadequate design or maintenance.

Eighteen events fell into this category making this the most frequently reported problem.

AECL records indicate a source mechanism malfunction occurred at RTI, Rockaway, New Jersey, on March 18, 1979, but no details were available (ref. 15). There are 14 additional reports of the source rack becoming stuck, and in two of these, a fire resulted (see Section 3.5, below).

The best documented of these events took place at the Armed Forces Radiobiological Research Institute (AFRRI) facility in Bethesda, Maryland, in which a robot was used to return the stuck source to the pool (ref.17).

This event was less of a potential problem than it might have been at another facility because the AFRRI facility was designed to be flooded, if necessary..

Stuck' source racks have been reported most frequently at the Johnson & Johnson facility in Sherman, Texas (ref. 15, 18). The reported causes of these events were design defect, inadequate maintenance, and ureknown (twice).

On March 3,1985,.a source plaque became stuck in an exposed' location at the i International Nutronics, Inc., facility in Irvine, California, because the aluminum shroud had become distorted and caught'on the plaque frame. This was later determined to be the result of a design problem, although inadequate maintenance was a contributing factor'(ref. 19; NRC IN 87-29, Item 6).

On July 17 1986,~a source plaque at the.RSI Schaumberg, Illinois, facility 3

became stuck in a less than fully shielded position, because the cable had become' frayed and jammed. The fraying problem had been identified earlier, but a decision had been made to wait to correct.this until the scheduled maintenance.

Employees cut the cable and let the source plaque free-fall into the pool (NRC IN 87-29, Item 5).

The licensee contacted NRC Region III at the conclusion of this event although it believed, and NRC Region III agreed, that this event was not reportable under existing reporting requirements.

0n the early part of the r.ight shift (7-11 p.m. on November 13, 1986),.at the RTI Rockaway facility an operator noticed a slow movement of the source to the

. fully unshielded position. The source was raised but could not be lowered by normal or emergency means. The operator believed this was due to a frozen control valve in the line supplying air to raise or lower the source, took action, and freed the source by 2:34 a.m.

The inspection report (ref. 20),

noted that this involved two violations (1) failure to immediately notify the RSO when the source failed to return to the shielded position; and, (2) failure to obtain authorization and approval of repairs to a safety-related component of the irradiator (ref. 21). This was categorized as a license violation.

l l

Cable failures were reported at RTI, Rockaway, New Jersey, on September 15, l

1981, (ref.14), and at Becton-Dickinson, Oxnard, California, on May 7,1982 (ref. 15).

The RTI cable failure was found to be the result of abrasion again.st the cable housing rather than cable fatigue, and the action to prevent recurrence included an improved maintenance program.

A report was not available on the cause of the Becton-Dickinson cable failure.

An NRC inspection report noted that difficulties were experienced with conveyor movement at the RTI Rockaway facility on January 8,1987, and that the operator physically shook the conveyor to get the boxes.to move into position around the Maze (ref, 16).

At 2 a.m. on March 7, 1988, the source cable broke at the RTI facility in Rockaway, New Jersey.

As a result, a sourc'e module bent and the pencils could only be removed with difficulty. All the modules.were inspected, squared, reloaded, and reinstalled in the source assembly. A new cable was installed and the equipment made ready for operation by 9 p.m. (ref. 48). While there was no clear requirement that the event be reported, NRC Region I requested that a report be submitted when it became aware of the uncontrolled drop of the source l

assembly and the subsequent damage.

i,

s To summarize, although equipment malfunctions have'been the most frequently reported events, there have.been no radiation overexposure or facility contami-nation events that were' solely the result of an equipment malfunction-or failure.

' This event category is important because it contains precursor events.

How-ever, these events are. generally not required to be reported.

For example,-

10 CFR 20.403(b)(3) 3/ requires that an event be reported if.it results in loss of one-day or more of operation of the facility.

3.4 Release of Radioactive Material These events are those in which material was, or might-have been, released to on-site and off-site' areas.

In >1976, at the Isomedix Parsipanny, N.J. facility, a cover over the storage pool caught fire as a result of welding operations, and a chemical fire extinguishing material was used to put out.the fire.

It was believed that chemicals in the fire extinguishing material contaminated the pool water and caused corrosion and leakint of a source (s).

The pool water was processed to. remove the Co-60 and was released to the sewer system.

Some piping became contaminated (ref. 22).

In OcteDer 1982, high lovels of Co-60 were reported to be present in the l

storage pool of the International-Nutronics Incorporated (INI) facility in Dover,Idew Jersey, (ref. 23, 24), and efforts were undertaken to clean up the pool. It was later found that a source had been damaged in 1974, but had not been ro orted because measured pool Co-60 levels never exceeded 5.0E-5 microctries per milliliter. On December 31, 1982, during unattended clean up operatians at the facility, a pool clean up system line broke and pool watu was released to the facility floors and to the soil'outside.

It cost approximately $2 million to clean up the facility, o

l ft about 6:00 a.m. on September 22, 1986, an operator entering the RTI facility in Rockaway, New Jersey, observed that a-low water level alarm had been j

i.

activated, possibly indicating low water levels in both of the storage pools.

He then found the pool purification system had failed during unattended operations. Water from the pool was discharged to the purification pump room and drained to the site's sanitary sewer system (ref. 25). The pool water did not contain elevated levels of Co-60.

Excavations conducted at the RTI Rockaway facility site during June 1987, uncovered radioactive contamination and toxic chemicals.

However, evidence indicated that the radioactive material was generally contained and had not i

migrated (ref. 26).

Prior to 1981, burial of low level contamination might have been permitted, but such burial had to be documented.

3/ If the licensee finds that less than one day's operation is lost, then the licensee need not report the event.

l

-11" 1

On June 7, 1988, DOE reported possible leakage of WESF Cs-137 capsules at the Radiation Sterilizers facility in Decatur, Georgia.

Elevated radiation levels above the surface of the pool indicated leakage from one or more capsules (ref. 49). The initial information on this capsule leakage problem indicated that source capsules containing Cs-137 in such a soluble form may not be suitable without better leak detection systems.

However, the investigation of

~

this was only beginning while this report was being prepared.

Although releases of radioactive material have rarely' been reported, and the resulting contamination was contained expensive clean up operations have resulted, even when there was no appreciable leakage from the pool. The problems lead to a number cf principles for design and operation of irradiators:

storage pool water must be pure and leakage of the poo'l water minimized; representative sampling of pool water is necessary'to identify contamination promptly; consideration should be given to having the purification system drain back to the storage pool if any failure occurs; Land '

written procedures should exist for operation of the pool purification system, including the conditions necessary for unattended operation

3. 5 Fires Several fires have been reported at U.S. and foreign irradiators.

The earliest reported fire occurred on July 30, 1980, at the Ethicon facility in Somerville, New Jersey, while the facility was shutdown for maintenance.

A dose-mapping study was underway that consisted of static irradiation of corrugated cardboard boxes filled with corrugated filler material. About 10 minutes after the source had been returnad to the pool, personnel entering the radiation room noticed an odor of " toasted" cardboard. After rearranging the carriers for operation, two attempts were made to start the conveyor system, with the system shutting down after each attempt.

After a third shutdown, smoke began emanating from the irradiation room, and a call was made for the fire brigade at 4:43 p.m..

The fire brigade members, wearing Scott air packs and carrying a fire hose, a flashlight, and a rddiation survey instrument attempted to enter the irradiator and extinguish the fire, but could enter only part way because of the smoke.

Af ter a crane was used to remove the two roof plugs (each weighed about five tons), the smoke cleared from the room and the fire was extinguished shortly after 8:00 p.m. (ref. 27).

Ethicon later concluded that the fire resulted from the static dose mapping during which there was no tote carrier movement.for time periods of from 22 minutes up to 7 hours8.101852e-5 days <br />0.00194 hours <br />1.157407e-5 weeks <br />2.6635e-6 months <br />.

Cticulations indicated that a portion of the corrugated material had absorbed a dose of over 50 megarads and that the temperature of the filler may have increased to the ignition temperature, estimated at about 450 degrees F.

It was thought that the deteriorated condition of the boxes and elevated concentrations of ozone may have increased the likelihood of the fire (ref. 28). This event occurred because possible consequences of the dase mapping were not adequately considered before the mapping was initiated. _ _ _ _ _ - - _ _ _ _ - - _ - _ _ - -

v On October 24, 1980, a fire occurred at the Becton-Dickinson facility in Broken Bow, Nebraska.

At about 11:50 a.m., personnel found they could not return the source rack to the storage pool and a number of unsuccessful attempts were made to free the source rack.

Personnel contacted AECL about 1:00 p.m. and requested assistance, and took the actions recommended, but without success.

The fire broke out at about 9:00 p.m.

At 10:40 p.m., a sprinkler head inside the cell fused, sounding the fire alarm, and putting the fire out.

The water was turned on twice between then and 1:30 p.m., October 25, to put out other fires.

When AECL representatives arrived on the site about 1:10 p.m. on October 25, thick smoke was still coming from the cell.

They successfully freed the sources in about one-half hour.

An investigation found that the source rack had become jammed because damaged product totes interfered with source movement (ref. 29).

On May 14, 1981, a fire occurred at the Becton-Dickinson facility in North Canaan, Connecticut.

At about 5 p.m. aluminum totes jammed into the source rack, and several unsuccessful attempts were made to free the source by manually raising and lowering the hoist cable.

Eventually, the panel lights indicated the source was down, but radiation levels in the cell remained high.

AECL was then contacted.

On the morning of Friday, May 22, (8 days later),

AECL was notified that the sprinklers had actuated and that smoke was coming from the cell.

At that time, AECL personnel travelled to the facility.

The source rack was raised and lowered until it came loose and was lowered into the pool.

A TV camera found the top center module and some pencils from the lower center module were missing from the source storage rack.

The module and pencils were located and returned to the pool, using mirrors and tools through holes in the roof.

and a shroud was installed around the source rack.The aluminum totes were redesigned to Both this event, and the earlier fire at Broken Bow, resulted because damaged totes were being used to convey material (ref. 30, 31).

It is not M aar whether personnel at the Becton-Dickinson facility in North Canaan were aware of the fire at Broken Bow six months earlier.

On January 31, 1982, a fire occurred at an irradiator facility in Indonesia.

The source had become stuck in the unshielded position because of interference between the source and product or product conveyors.

After a number of unsuccessful attempts were made to free the source, a decision was made to let the product deteriorate sufficiently to free the source.

When the fire broke out 11 days later it was extinguished but only after the facility was completely destroyed.

The replacement facility that was ordered was to have a source shroud (ref. 32).

Shortly after 2 p.m. on November 13, 1982, a box being loaded into the product carrier became jammed during unattended opera + ions at the Johnson & Johnson, Sydney, Australi', facility.

At about 5 a.

on November 14, 1982, a fire broke out that damaged the goods being irradiated and the irradiator itself.

The fire occurred because of the product jam and the failure of a protective interlock to shutdown the unit.

This malfunction was thought to be the result of a modification by the facility operator in which a 115V relay was used to replace a 12V relay.

In spite of this, the ensuing fire would probably not have occurred if the console timer system had been of the proper design or the in-cell temperature sensor had been correctly installed (ref. 33, 34). _

The most recently reported fire occurred on the Permagrain facility site in Karthaus, Pennsylvania, on December 1, 1987. The fire occurred in an auxiliary building that was used to store sawdust, and did not affect irradiator operations (ref. 35; not reported by LER).

The events point out a number of principles for large irradiator design and operation. The events illustrate the need for a shroud to separate the source and product carriers. The Ethicon fire event shows the need to preplan operations, including considerations of gamma heating, (it seems unlikely that the dose mapping that was performed vould have been authorized). The Becton-Dickinson fires show the need to inspect and maintain equipment and the value of reviewing operating events at other facilities in order to make the changes necessary, to avoid those events.

The fire at the Johnson & Johnson facility is clear evidence of the need to operate and maintain an irradiator facility in accordance with the approved design and procedures.

3.6 Management Deficiencies Management problems have resulted in license violations and suspensions.

3.6.1 International Nutronics Incorporated (INI), Dover, NJ The International Nutronics facility in Dover, New Jersey, was plagued with a number of incidents that appear to have been the result of management decisions.

As was noted in Section 3.4, in October 1982, a high contamination level in the storage pool was discovered that was thought to be the result of damage that had been done to the scurces in 1974. When efforts were made to clean up the storage pool, a spill occurred during unattended clean up operations, and INI employees tried to conceal the fact (ref. 36).

The corporation and a management employee (a Corporate Vice President and Corporate Radiation Safety Officer of INI) were prosecuted for this and found guilty (ref. 37).

The conviction resulted in a fine for the corporation and two years probation for the management employee.

The $2 million dollar cost of clean up and decommissioning of the facility were paid by Lexington Insurance Company.

The license was terminated on November 10, 1986 (ref. 37, 38).

3.6.2 Radiation Technology Incorporated (RTI), Rockaway, NJ Deficiencies in management have been the apparent cause of reported problems at the Radiation Technology Incorporated, facility in Rockaway, New Jersey.

An inspection of the facility in October 1976 identified a number of violations for which the licensee was fined (ref. 39a). As was noted in Section 3.1, a significant radiation overexposure occurred in September 1977, because safety interlocks were bypassed.

In September 1984 it was again found that the safety interlocks were being bypassed.

As a result, a Confirmatory Action Letter was issued that required that RTI operate the facility only if all safety interlocks were operable, and shut down operations if any safety interlock failed to function as required. __

M uF i

I In February 1986 an NRC Region I inspection again found that the Rockaway facility had been operated with a required radiation monitor inoperable.

On March 3, 1986, Region I issued an order suspending the RTI Rockaway license (ref. 39b), but on March 13, 1986, issued a conditional rescission of the order because the licensee agreed to third and fourth party oversight of l

facility operations with uncensored performance reported directly to the NRC.

On March 20, 1986, during a special, unannounced inspectior, another violation was identified.

On March 13, 1986, the licensee had useo licensed material prior l

to NRC receipt and verification of the licensee's contract with its consultant.

The NRC determined that these and earlier RTI problems constituted an abnormal occurrence because they were due to a breakdown in licensee management control.

On June 23, 1986, Region I issued an order suspending RTI's license, based on the results of an investigation that had been conducted in response to concerns expressed by the third party oversight organization (ref. 39b).

The investigation found that the third party had not been informed of all equipment malfunctions.

The licensee deliberately bypassed safety interlock systems.

RTI admitted the violation and proposed a corrective action program that included changes in management. On August 22, 1986, the NRC lifted the suspension for a six-month probationary period (ref. 40).

On March 16, 1988, the current president of RTI pleaded guilty on behalf of the company to two felony charges involving safety violations, including charges that the company had submitted falsified memorandums to the NRC (ref. 41).

3.6.3 Radiation Sterilizers Incorporated (RSI).

On January 14 and 27, 1987, the NRC parformed unannounced, routine safety inspections at Radiation Sterilizers' Schaumberg, Illinois, and Westerville, Ohia, irradiator facilities (ref. 42).

During the inspections, a number of license violations were identified, including: (1) Failure to te3t smoke and I

temperature alarms; (2) Failure to maintain an operable warning beacon in the maze entrance, and, (3) Failure to maintain operable control panel water level indication and an operable system to detect and shutdown the irradiator in the event of excessive water loss from the pool.

The NRC determined that these problems constituted an abnormal occurrence because they were the result of a breakdown in the management oversight and control (ref. 43).

3.6.4 Precision Materials Corporation (PMC), Mine Hill, NJ During an inspection on July 23 and 24, 1987, Region I became aware of a high rate of water loss from the storage pool of the Precision Materials Corporation facility in Mine Hill, New Jersey (the storage pool did not have a stainless steel liner).

(leakage) and measure the Co-60 concentration in the storage pool moreAs a re frequently.

At a meeting with Region I on August 31, 1987, the licensee noted that the pool.was leaking at the rate of about 20 gallons per hour, and because of financial difficulties the company was experiencing, the company officers and the RSO planned to resign momentarily.

As a result of these problems, on September 4,1987, the facility was ordered to suspend operations; to monitor the pool to maintain level and to detect radioactive contaminants; and to either (1) provide a basis for the resumption of licensed activities, or (2) transfer the sources to another authorized licensee (ref. 44).

The licensee chose to transfer the sources. After the sources were removed and the facility released for unrestricted use, the license was revoked on February 11, 1988, (ref. 45). This event was important for a number of reasons.

First, it showed that specification of an " impermeable" pool liner may not be suf ficient to ensure that leakage will not occur, because certain types of liner materials may degrade with time.

Second, this event shows the importance of monitoring pool inventory and make up to ensure that leakage is not occurring.

Third, this event shows the need for licensees to fully understand the:r responsibilities.

Licensees must be aware of, and committed to, carning out the conditions of the license.

Finally, this event is important because it shows how changes, such as changes to finances, can adversely effect a licensee's i

performance.

3.6.5 INI, Palo Alto, CA As the result of bankrupcy proceedings, the inventory of sources had been sold and removed from the storage pool of the International Nutronics, Inc.,

facility in Palo Alto, California.

In May 1988, while the pool was being drained, radiation levels increased to about 25 mr/hr with five feet of water still in the pool.

The draining was stopped. Analysis of the pool water showed the radiation was not due to contaminants in the water.

Further investigation found the elevated radiation level was due to sources still in the pool that were not part of the facilities inventory (ref. 50).

This loss of accountability for the sources in the storage pool shows the need for quality inventory records.

3. 7 Natural phenomena There were two events reported that were the result of natural phenomena.

Neither event was significant from a safety standpoint.

There was a tornado at about 8 p.m. on May 31, 1985, near the Permagrain Products facility in Karthaus, Pennsylvania. Although there was minor damage to property, there was no damage to the irradiator itself (ref. 46).

The Isomedix facility in Sandy City, Utah, reported that six separate earth-quakes of magnitude, 3.9 to 4.8 on the Richter Scale, centered approximately 120 kilometers northwest of the facility.

The largest event in the sequence occurred on September 24, 1987.

The largest had a peak horizontal acceleration of 0.01g.

A state inspection on October 7,1987, verified the faciHty had sustained no damage and that there had been no increase in make up water volume (ref. 47).

The facility has a stainless steel pooi liner.

3.8 Summary of Root Causes Table 4 lists types of events that have occurred in the United States and the causes of those events.

a..

Table 4 ROOT CAUSES OF EVENTS AT LARGE POOL-TYPE IRRADIATORS LOCATED IN THE UNITED STATES Design Natural Management Defect Mai ntenar>ce Phenomena Unknown Radiation Overexposure Real 2

Badge OE 1

Safety Interlocks Defective 3

Bypassed 3

Equipment Problems Source Mechanism 3

2 6

Cable Failure 1

2 Conveyor Malfunction 1

Source Assembly Damage 1

Material Release Contamination 2

2 f

Spill 2

Fires 3

i License Problems (Violations,etc) 7 Miscellaneous Loss of Accountability 1

Operating Conditions 2

20 6

3 2

14 Total 45 1

4.0 ANALYSIS OF EVENTS AND LESSONS LEARNED Only a few cf the 45 events identified at U.S.

irradiators were significant from a safety standpoint, that is, had an impact on health and safety. Most of the events fall into the category of precursor events, and the outcome might have been significant under different circumstances.

In Section 3 of this report, the events at the large irradiators were classified by the type of events.

To assess the contributions of specific systems and management practices to events, in this section the events have been aggregated into events stemming from system problems, management deficiencies, and natural phenomena.

Events stemming from system problems -- this category includes all events in which a system failed to operate as designed, even if the failure is ascribed to inadequate maintenance programs, etc.

Events stemming from management deficiencies -- this category contains only those events in which there was no system failure or in which management bypassed an inoperable access control system.

Natural phenomena and other site problems -- this category contains only those two events containing information on the ability of irradiators to withstand natural phenomena and another event involving a fire at a site.

Of the 45 events discussed in Section 3, 31 involved the failure, malfunction, or degradation in the performance of some irradiator system.

These systems include: access control; source mechanism (movement and suspension); source encapsulation; and potl (leakage and clean up).

An additional ten events stemmed from management deficiencies. There were three events involving natural phenomena and other site problems. One event, a badge overexposure, was not reviewed in this section.

4.1 Events Stemming from System Problems 4.1.1 A_ccess Control Systems The regulations (10 CFR Part 20.403 (c)) which became effective in 1978, required improved access controls for irradiators. The two overexposure events that occurred in 1974 and 1977 occurred with access control systems that did not meet these Part 20 criteria.

In addition, in both cases, the access control system was not operating as designed when the overexposure occurred.

In the 1974 event, the operator entered a hot cell with the source exposed. When he entered the cell he did not use a survey meter and the audible remote area alarm had unknowingly been turned off at the main console in front of the cells. 4/ In the 1977 event, construction activity resulted in the source-up warning light being obscured from vision; in addition, the electrical interlock on the door was not in order.

4/ Another aspect of the event is the fact that the hospital to which the overexposed individual was taken was initially unaware of procedures for admitting the patient or what dangers to hospital staff did or did not exist. Approximately two hours elapsed before knowledgeable hospital staff arrived on the scene. -_ _ _ _ _ _

6 There was a third event reported in 1978 that involved the access control system.

It was discovered that failure of two door interlock switches could cause the source to move from the safe storage to the exposed position.

The s posure event at the Norway irradiator that resulted in the death of an in Cridual involved an access control system that was not functioning properly.

A review of the event states that the facility design included safety signals and operational signals that were not segregated and that were not optimally designed from a human factors standpoint. At the time of the accident, a microswitch had failed, which permitted the locked door to the irradiator cell to be opened.

In addition, the failure of the particular microswitch also produced a ' source shielded' signal.

A separate positional display gave the correct signal that the source was exposed.

The three American events and the Norwegian event point to the need for potential licensees to perform a detailed sarety analysis of the access control system to assure that the system meets the criteria of 10 CFR 20.203 (c)(6).

It should also be noted that although 10 CFR 20.203 (c)(6) required that access controls be operational, there is no requirement that licensees report or

{

record the nonfunctioning of the controls.

4.1.2 Source Movement and Suspension The greatest number of events that occurred at American irradiators concerned events in which the source movement was impeded or the source suspension (cable) system was damaged.

There were of 13 events that involved interference with source movement and seven events that involved the source suspension cables.

4.1.2.1 Source Movement Of the 13 events in which source movement was impeded, there were insufficient data in five events to ascribe a cause to the event.

In six events, the product carriers uterfered with the movement of the source plaque.

In five of these six even w the effect of the interference was direct.

In one event, the interference was indirect.

In that event, as a pneumatic ram attempted to push a tote from a conveyor into a tote carrier, it became jammed.

The jammed tote flexed and resulted in the tripping of a circuit breaker of the control circuit.

The source began lowering itself into the shielded position; since loss of the control circuit caused the loss of the source-down position sensor, the source cable drum continued to rotate and raised the source to the full up position before the motor stalled.

The source was lowered manually.

There were two evenu, ir/Jolving degradation of the source movement capabilities that had unique causes: at a research irradiator, interference between an experiment and the source impeded movement of the source; and low temperatures at one irradiator appear to have been responsible for impeding movement of the source.

3 s b

Most of these even u w m benign in that there'is no known impact on the facility except possible 1o

of production. Two of the events in which 5

movement of the source plaque a s impeded did result in fires inside the irradiation chamber, and two event: resulted in individual source pencils coming loose _from the source plaque. One event resulted in distortion of the source plaque.

Although the events were benign, their occurrence represents some increased risk o'T damage to the radioactive source an,1 some small decrease in the safe operation of the facility.

Little information was available on licensee actions to reduce the occurrence of these events.

For the two events in which fires resulted from the events, the licensees committed to an improved inspection program for the product totes, with deformed totes being taken out of ser/ ice for maintenance.

4.1.2.2 Cable Problems i

There were six reports of problems with source suspension cables.

In three of the events, the cable broke; in two, the cable frayed. In one event the cable I

came off its pulley. There were no known deleterious effects of any of these 1

I events. As with the events in which the source movement was impeded, cable problems do represent an increased risk of damage-to the facility and the sources.

In two of the events involving cable failure, there are i.ndications of some deficiencies in maintenance practices.

In one event, the cable was known to be frayed; in the other, the cable had not been inspected for at least three years. Commitment by licensees to some regular inspection program for the source suspension system, including the entire length of the cable, should reduce the probability of cable failures.

1

)

It should be noted that some licensees have considered that cable failures need not be reported to the NRC.

To obtain uniform reporting of these events would require specific mention in the regulations.

4.1.3 Encapsulation There have been four events in which the encapsulation of the radioactive sources appears to have failed, resulting in contamination of the storage pool.

In one t

event, an event early in the facility life resulted in the chemical contamination of the pool water. The licensee hypothesized that this chemical ~ contamination ultimately led to corrosion of the source encapsulation and subsequent contamination of the pool water.

In a second event, a source was damaged in 1974 from mishandling. An excessive contamination level in the pool was reported in 1982. The contamination was not uniformly distribut~1 throughout the depth of the pool.

Late in 1976, an irradiator facility determined that the Co-6L concentration in the water of a research and development pool was 0.0013 uCi/ml. The licensee stated that the activity level may have been the result of corrosion s: ale

. activity from a batch of Co-60 sources recently installed in the pool ar,

activity from one source that had a loose cap. Demineralization of the pool water successfully reduced the activity of the peol to normal operational *,evels.

The suspect source was stored.

i

.go.

t l

A recent event involved the leakage of a Cs-137 source, with the resulting.

release of 10 or so curies of Cs-137 to the pool.

This event led to fears that contaminated product might have been shipped from the plant.

No contaminated product had been shipped (ref. 51).

The two leaking source events demonstrate that pool sampling must be representative to detect source leakage; and, although 10 CFR Part 20.203 (c) requires licensees to have the capability to detect radioactivity leaving the irradiation ~ cell, the recent Cs-137 leak raises the question of whether this detection system is adequate to detect product contamination or whether pool contamination level or rate of increase of pool' contamination would give an earlier signal that the potential exists for contamination of packages.

-4.1.4 Pool Leakage and Pool Purification System There were three events that involved pool leakage or pool clean up system failure (leakage).

In the case of.the leaking pool, the existence of a high l

rate of water loss from the storage pool was noted by an NRC inspector during I

an inspection that NRC Region I performed in response to allegations. After discussions with the NRC, the lice see agreed to monitor the rate of pool leakage.

This event suggests that licensees be required to develop actions that will be taken if pool ma:ke up reaches some licensee-specified amount.

There were two events in which there were failures in the posi water purification l

system.

In one event, the piping on the discharge side of the purification i

system pump failed.

In the first failure,~the piping was suitable for cold temperatures, but the pool temperature was 120', and joints had recently been torqued.

In addition, the leak developed when the irradiator was unmanned and there was apparently no low pool level shutoff on the purification pump.

In the second event involving a pool purification system leak, a line separated and contaminated j

water spilled into the facility. Small amounts of contamination were later found outside of the facility.

The purification system was being operated unattended in this event.

It is obvious that systems should be designed to operate under the conditions that they will experience; i.e., material properties should be adequate for the plant conditions that the materials will see. There are other lessons demonstrated by tne pool purification system failures: there should be an automatic shutdown of the system.if the' pool-level reaches some~ low level; and, there'should be a

. cost-benefit analysis made to determine whether it: is 'necessary to have leakage.

from the pool water purification system drain back to'.the pool or some facility sump.

4.1.5 MJcellaneousSystems There were two events that involved. miscellaneous systems. 'The first event involved problems'with timers. 'It was reported not only to'an Ageement State

~

by its' licensee, but also to the NRC as a Part 21 report by the manufacturer.

The_second event involved malfunction of pistons used to engage clutches in j

the product conveyor system.

4.2 Management Deficiencies l

There were ten events ascribed to management deficiencies of one type or-another. In one event, a dose distribution study that involved the stationary irradiation of cardboard, a fire resulted from gamma heating of the cardboard.

This was the only event with demonstrable consequences'in this group'~of ten events.

The most common management deficiency was operating an irradiator without-1 operational interlocks required by 10.CFR'20.403 (c),- with several _ events

-}

reoccurring at the same facility.

4.3 Natural Phenomena and Other Site Problems There were three events in this category, none of which had:an) known ' impact on I

the irradiator at which the event occurred. One irradiator site was struck by a tornado. The storage pool was unaffected. A second irradiator was about-120 km from the epicenter of a series of'six. earthquakes of from.3.6 - 4.8 l

magnitude. The irradiator itself was inspected by' state licensing personnel and found to be undamaged.

)

In a third event, there was a fire at an irradiator facility _in a building that was separate from the irradiator.

The building was.used to store sawdust, a

{

combustible material.

The irradiator suffered no damage.

These three events do not contribute much knowledge about external events affecting operational events at irradiators.

In the two events involving natural phenomena, the irradiators were-unaffected. The event involving a fire in an auxiliary building of'an irradiator facility demonstrates that there may be unrelated site problems that could have some impact 'on the irradiator itself.

5.0 FINDINGS The review of events at large pool irradiators showed that there were 45 events reported during the approximately 360 irradiator years of operating 3

experience, a fregency of about 0.12 events /irradiator year. Of the 45 events, j

only about 10 - 20 percent had significant consequences. Hence, the frequency of significant events appears to be on the order of 0.01 - 0.02 events /irradiator 1

i.

year. Since there are few specific reporting requirements for_irradiator events, the overall frequency may be greater than predicted by this report.

The events in the report show that there have been failures in several safety-important systems: access control, source movement and suspension, encapsulation, and pool leakage'and purification system.

It is suggested that the requirements for the operability of these systems be assessed, together with an assess.nent of the need for licensees to define action levels if system function falls

,1 below some predetermined value.

j Current requirements for the reporting of events at-irradiators are not.

l adequate to identify potential problems at a facility, nor to identify possible generic problems. For example, if a source is stuck in an unsN-M d position, or there is an uncontrolled drop of the source assembly, there io no i

requirement that this be reported, unless it is reportable for some other reason, for example, the facility must shut down operations for more than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.

6.0 CONCLUSION

S AND RECOMMENDATIONS It is suggested that during the development of a regulation for large pool-type irradiators consideration be given to:

l requirements for reporting breakdowns in access control systems; i

i requirements for periodically inspecting the source movement and I

suspension system; requirements for licensees to have effective means of accurately detecting source leakage and subsequent potential product contamination; requirements that licensees specify allowable pool leakage, as well as requirements for automatic shutdown of the pool purification system in case of system failures; and, specifying reporting requirements that assure that there is feedback of information on operational events involving safety-important systems.

r ____ ___

_ _ - _ _ _ _ _ _ _ _ _ - _ - _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ - - _ - _ = - -

7.0. REFERENCES

.)

1. " Radiation Accidents: A Conference Review," L.A. Sagan and S.A. Fry; I

Nuclear. Safety, Vol. 21, No.

5,_ September-October 1980.

2. "A Dosimetric Study of the Belgian (1965)'and Italian (1975) Accidents,"

N.C. Parmentier, J.C. Nenot, and H.J. Jammet; The Medical Basis for Radiation Accident Preparedness, K.F. Hubner and'S. A. Frys, Eds., Elsevier,.

1980.

3. "The Radiation Accident at Institute for Energy Technology, Sept. 1982, Some Technical Considerations," 'Leiv Berteig and Jon Flatby, National Institute of Radiation Hygiene, Norway; J..of Indust. Irradiation Tech., 2(3&4), 309-319 (1984).

4. NRC Region I Investigation Report No. 74-01, dated August 8, 1974; License-

1. 29-15364-01,

5. "The New Jersey Radiation Accidents of 1974'and 1977," Barlotta, Flora M.;

The Medical Basis fo Radiation Accident Preparedness, K.F. Hubner and S.A. Frys, eds! Elsevier, 1980.

6. Licensee report, dated July 6, 1982, from-Isomedix, Inc., to NRC, Region I; NRER #82-069

7. Letter, dated January 20, 1978, from Converters to the Texas Department.of Health Resources.

8. 10CFR21 Notification Report, dated April 19, 1985, from AECL~to the NRC.

9.. Licensee report, dated September 25, 1987,~ from Ethicon,-Inc, to NRC, Region I.

10. NRC Region I Inspection Report 30-06990/87-01, dated April 19. 1988.

11. NRC Region I Combined Inspection Report Nos. 30-07022/84-01 and 30-19146/84-01, dated December 29, 1986.

12. NRC Inspection Report Nos. 30-07022/86 01 and 30-19146/86-01, dated April 4, 1986.

13. NRC PN0-I-87-81, dated August 19, 1987.

14. Licensee report, dated September 15, 1981, from Radiation Technology, Inc.,

to NRC Region I,

15. Letter, dated August 10, 1982, from AECL to Texas Department of Health, Bureau of Radiation Control.

16. NRC Region I Combined Inspection Report Nos. 30-07022/87-01 and 30-19146/87-01, dated May 28, 1987.

l 3

17. Licensee report, dated June 16, 1981, from the Defense Nuclear Agency to-the NRC Region I. 'i

i I

l 18.

Letter, dated October 27,'1987, from the Texas Department of Health to the NRC, GPA.

i 19.

State of California Department offHealth, Radiological Health Section-Report, dated March 11, 1985.

20.

NRC Region I Combined Inspection Report Nos. 30-07022/86-18 and-30-19146/86-18, dated January 6, 1987.

21.

Letter, dated April 10, 1987, from. Radiation Technology, Inc..to NRC Region I.

22. AECL notes, dated November 16, 1986.

L

23. NRC Confirmatory Action Letter 82-25, dated October. 29. 1982.

24.

Licensee report, dated December 23, 1982, from International Nutronics, Inc.,

j to NRC Region I.

25. :NRC Inspection Nos.'30-07022/86-14 and 30-19146/86-14, dated October 10, 1986.

26.

Letter, dated September 15, 1987, from NRC Region I to Radiation Technology, Inc.

27.

Licensee report, dated August 28, 1980, from Ethicon, Inc., to'NRC Region'I.

28.

Supplementary information on the fire at the Ethicon Sommerville facility was provided to the NRC in a memorandum dated April 15, 1988, 29.

Letter, dated December 5, 1980, from State of Nebraska Department of Health to the NRC Office of State Programs.

30.

Letter, dated June 16, 1981,. from AECL to Becton-Dickinson 31.

Licensee report, dated June 23, 1981, from.Becton-Dickinson to NRC Region I.

32.

Letter, dated February 19, 1982, from P.T. Giri Kencana Jaya to AECL.

33. AECL memorandum, dated November 25, 1982.

34.

Ethicon, Inc., memcrandum, dated February 16, 1983.

35. NRC Region I Preliminary Notice of Occurrence PNO-I-87-112, dated December j

2, 1987.

36.

NRC Region I Request for Investigation of International Hutronics, Inc.,

dated October 6, 1983.

37.

NRC PNO-I-86-89A, dated December 5, 1986.

1 i

38. Amendment 19 to NRC License #29-13848-01, dated November 10, 1986.

1 1 ;

139a. NRC Region I Inspection Report and Notice of. Violation, dated January 5, 1977, License #29-13613-02.

39b. NUREG-0940, Vol.6, No.1, Enforcement Actions: Significant Actions Reso'Ived; p.II,A-73.

40c License No. 29-13613-02 Renewal,' dated August 22, 1986.

4L New York Times, March 20, 1988; p.38.

42. NRC Region III Inspection Report No. 030-19025/87-01, dated March 17, 1987.

43. Abnormal Occurrence 87-5, NUREG-0090, Vol.10, No.l.

44.

NRC Region I Order Modifying License 29-20777-01, dated September 4, 1987.

45. NRC Order Revoking License 29-20777-01,' dated February 10, 1988.

46.

NRC Inspection Report No. 030-13537/85-01, dated September 16 1985.

i 47.

Letter, dated October 26, 1987, from Utah Department of Health, Bureau of.-

Radiation Control to NRC, Office of State Programs'.

48.

Internal Memorandum, Radiation. Technology, Inc., dated March 31, 1988.

49.

NRC'PN0-II-88-40, -40A, and -40B dated June 7, 8, and 9,.1988.

.50.

Region V to AE00 coinmunication, dated May 25,'1988.

51. NRC Region 11 letter to U.S. F.D.A. dated June 21, 1988.

l l

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Appendix C 1

REPORTING REQUIREMENTS FOR 10 CFR 20.403 l

Iss. des Neufleadens efineidents.

. distion; exposure of the skin of the l

(a) immsdiale notmestion. Each g.

whole body of any individual to 30 censee shad immeentely report any rems or more of radladon; or esposure events involving byproduct. source, or of the feet, ankles, hands, r,r forearms special nuclear material possessed by to 78 rems or reori of rsdiation; or the llansee that may have caused or (3)The release est radioactive mater 1 threatens to cause:

al in concentrations which. If averaged (1) Exposure of the whole body of over_ a period of 34 hours3.935185e-4 days <br />0.00944 hours <br />5.621693e-5 weeks <br />1.2937e-5 months <br />, would any ladividual to 38 rems or more of exceed 800 times the limits specified redisuon; exposure of the skin of the for such materials in Appendiz 3, whole body of any individual of 180 Table H of this part; or rems er more or radiation; or exposure (3) A loss of one day or more of the

- of the feet, ankles, hands or forearms operauon of any facilities affected; er of any Individual to 378 rems or more (4) Damage to property la escens of of radiation

• er

$3.000.

(3)The release of radioneuve anaterl-(c).Any report fDod with the Coma.

alin concentrations which. If avernsed mission pursumt to uns acetion ahat ovet-a period of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, would be prepared so that names of Indivle.

esesed 8.000 lisses the Halte specifleal unas who have received espesure to en.

for such materials in Appendix &

diauon wiu be stated in a separate Table E of this part; or part of the rM (3) A loss of one working week er asere of the opersuon of any facilitica (d) Reports made by licensees la ro.

affected;er sponse to the requirements of this see.

tion must be made as foUows:

(4) Damage to property in excess of

$300.000.

(1)IJcensees that have an instaDed (b) fasenty-) bur Aour notMeelion.

Emergency Notificauon System shad Each lleensee shan within 34 hours3.935185e-4 days <br />0.00944 hours <br />5.621693e-5 weeks <br />1.2937e-5 months <br /> of make the reports required by part.

escovery of the event, report any graphs (a) and (b) of this secf.,lon to event involving licensed material pas.

the NRC Operations Center in accare.

sessed by the licensee that snay have ance with 4 50,73 of this chapter.

esused er threatens to cause:

(3) All other licensees shall make the (1) Exposure of the whole body of -

reports required by paragraphs (a) and any individual to 8 rems or more of rn-(b) of this section by telephone to the NRC Operauons Center a and by tete.

gram, mallgram or f,minne to the Adsalaistrator of the appropriate NEC Regional Offlee !!sted in Appendia D of this pan.

IM FM Sees, June St.1982, as amended at 30 FR tass, Jult 8,1988; 42 FR esses, assa..

1.1917; C8 FR 3119, Jan.19.1M3; et FB 88889. Juar St. 1983; 63 FR 83011. Sess. &

1981)

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BIBLIOGRAPHIC DATA SHEET NUREG-1345 nt Niimuci onion t t alvtR,,

3 te1LE ANO lust sTLE 3 LIAVE#LAN" REVIEW 0F EVENTS AT LARGE POOL-TYPE IRRADIATORS 4 DAf t Re# ORT COMPLETED MONT.

WtAM i AUr Oam September 1988 Eugene A. Trager, Jr

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mon 1-vtAa March 1989-P #f A.rOHMING ORGANit4TtON NAME AND MAILING ADDRESS t,vic%erle cede /

8 PROJECTIT A5m/wCRE UN T NUMetR Division of Safety Programs Office for Analysls and Evaluation of Operational Data

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U.S. Nuclear Regulatory Commission Washington, D.C.

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i e TYPE OF REPOssi Same at 7, above Special Case Study Report

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1964 - June 1988 12 SUFPLEMENTAR Y NOf t$

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is AasrR Act (200. ara, e, = ei Large pool-type gamma irradiators are used in applications such as the " cold" sterni cation of medical and pharmaceutical supplies, and recent changes in federal regulations make it possf ble they will be used extensively in the preservation of foodstuffs.. Because of this possible large increase in the use of irradiators, the Office of Nuclear Materials Safety and Safeguards was interested in knowing what events had occurred at irradiators.

The event data would be used as background in developing new regulations on irradiators.

Therefore, AE0D began a study of the operating experience at large, wet-source storage gamma irradiators.

The scope of the study was to assess all available operating informa-tion on large (more than 250,000 curie), pool-type irradiators licensed by both the NRC and the Agreement States, and events at foreign facilities.

i The study found that about 0.12 events have been reported per irradiator-year.

Most of these events were precursor events, in that there was no evidence of damage to the.

radioactive sources or degradation in the level of safety of the facility. Events with more significant impacts had a reported frequency of about 0.01 event-per irradiator-year.

However, the actual rate of occurrence of events of concern to the staff may be higher because there are few specific reporting requirements for events at irradiators.

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4 16 A A LAe Cesium-137 Cobalt-60 Contamination; Food preservation; Irradiators g

t Radiation overexposure;e; Radiation sterilization; Radioactive; Source Unlimited encapsulation; Source leakage; Wet-source storage.

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