ML20199K511

Proceedings of the Workshop on Large Irradiator Radiation Safety

ML20199K511
Person / Time
Issue date:	03/31/1986
From:	Lubenau J, Nussbaumer D NRC OFFICE OF STATE PROGRAMS (OSP)
To:
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NUREG-CP-0073, NUREG-CP-73, NUDOCS 8604100130
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NUREG/CP-0073

, Proceedings of the U.S. Nuclear Regulatory Commission ___

Workshop on Large Irradiator Radiation Safety Held at New Brunswick, New Jersey September 4-6,1985 U.S. Nuclear Regulatory Commission Office of state Programs Prepared by J. O. Lubenau, D. A. Nussbaumer p * "' % ,,

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NOTICE These proceedings have been authored by a contractor of the United States Government. Neither the United States Government nor any agency thereof, or any of their employees, makes any warranty, expressed or implied, or assumes any legal liability or responsibility for any third party's use, or the results of such use, of any information, apparatus, product or process disclosed in these proceedings, or represents that its use by such third party would not infringe privately owned rights. The views expressed in these proceedings are not necessarily those of the U.S. Nuclear Regulatory Commission.

Available from Superintendent of Documents U.S. Government Printing Office

- P.O. Box 37082 Washington D.C. 20013-7082 and National Techr ical Information Service e

Springfield , VA 22161 4.

NUREG/CP-0073

.Q ceedings of the U.S. Nuclear Regulatory Commission Workshop on Large Irradiator Radiation Safety H::Id at N;w Brunswick, New Jersey Scptember 4-6,1985 Manuscript Completed: November 1985 Date Published: March 1986 Prepared by J. O. Lubenau, D. A. Nussbaumer St:te Agreements Program Office of State Programs U.S. Nuclear Regulatory Commission W:shington, D.C. 20555 e s weg

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DISCLAIMER This report was prepared by employees of the United States Nuclear Regulatory Conunission. It expresses opinions that do not necessarily represent a staff position of the NRC. Other than approval for publication, this report has been neither approved nor disapproved.

ABSTRACT This document reports the results of an NRC-sponsored workshop on regulatory considerations for large (pool-type) irradiator radiation safety. The workshop focused on the following regulatory activities:

licensing, construction QA, source loading inspection, preoperational inspection, and initial and routine inspections. Workshop participants developed consensus views on most of the key elements of each of these regulatory activities. The workshop report has been prepared to serve as a radiation safety reference sourcebook in conjunction with available national design standards, regulatory requirements and regulatory guides for irradiator designers and operators, regulatory staffs and for persons involved in developing safety standards for these facilities.

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CONTENTS DISCLAIMER . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .iii ACKNOWLEDGEMENT. . . . . . . . . . . . . . . . . . . . . . . . . . .vii WORKSHOP ATTENDEES . . . . . . . . . . . . . . . . . . . . . . . . .vii

1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . 1

2. WORKSHOP REPORTS 2.1 Key Elements of License Application Reviews . . . . . . 5 2.2 Construction QA and Inspection. . . . . . . . . . . . . 9 2.3 Loading Inspection. . . . . . . . . . . . . . . . . . . 9 2.4 Key Elements of Pre-operational Inspections . . . . . . 10 2.5 Key Elements of Routine Inspections . . . . . . . . . . 10 2.6 Other Workshop Comments . . . . . . . . . . . . . . . . 11

3. APPENDIX: NRC AGREEMENT STATES . . . . . . . . . . . . . . . . 13

4. REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . 18 v

ACKNOWLEDGMENTS The conterits of this report are the product of a workshop of 48 State and Federal representatives, most of whom have regulatory responsibilities for radiation safety and a number of whom have been directly involved in the licensing and inspection of large irradiators.

Without their participation, the workshop would not have been possible.

The authors would especially like to thank Leonard I. Cobb, Donald A.

Chapell and Dr. John E. Glenn of NRC for their help in planning and carrying out the workshop.

WORKSHOP ATTENDEES NRC State Donald Nussbaumer, OSP Bernis Hannah, AL Joel Lubenau, OSP Donald Mackenzie, NC Lloyd Bolling, OSP Thomas Hill, GA Donald Chapell, NMSS Wilard Ingram, GA John Hickey, NMSS T. Pierce O' Kelly, SC Bruce Carrico, NMSS Richard Brisson, MD Nathan Bassin, HMSS Timothy Brooks, MD Leonard Cobb, IE Bill Lew, CA Jerry Counts, IE Stuart Rosenberg, CA John Glenn, RI Floyd Hamiter, TX John Kinneman, RI Jose Lopez, TX Frank Costello, RI Charles Mattson, C0 John McGrath, RI Harold Borchert, NB Carol Connell, RII Arnold Peart, UT Robert Brown, RII Michael Smith, MS Richard Woodruff, RII Terry Frazee, WA Patricia Whiston, RIII Michael Stevens, FL James Lynch, RIII Terri Chasteen, FL Jcck Whitten, RIV James Kopenhaver, PA Robert Doda, RIV Mark Smith, AR Beth Riedlinger, RV Paul Eastvold, IL David Skov, RV Jack Horr.or, RV Sanuel Pettijohn, AE00 Kathleen Black, AE00 Other Federal Garth Tingey, DOE (Battelle Northwest Laboratories)

Raymond Donnley, OSHA vii

LARGE IRRADIATOR RADIATION SAFETY A WORKSHOP REPORT

1. INTRODUCTION Radioisotopes have been used for comercial irradiatiog for about 20 years. In 1985, there were about 35 large irradiators licensed by the Nuclear Regulatory Comission and the Agreement States (Appendix 3).

The amounts of radioactive material authorized in these irradiators e range up to 10 megacuries, mostly in the form of cobalt-60. The main comodity irradiated today is medical products. Recent regulatory changes implemented and proposed by the Food and Drug Administration relating to food irradiation are likely to significantly increase the utilization of ionizing radiation in the comercial irradiation of various food products. These changes harbor an increased number of comercial irradiation facilities in the future. The Department of Energy is making available cesium-137 source capsules under a lease-allocation program. Interest in the cesium-137 capsules has sharply increased recently since current supplies of cobalt-60 are inadequate to meet all of the current and projected comercial irradiation needs.

Regulation of the radiation safety aspects of comercial irradiators using byproduct materials such as cobalt-60 and cesium-137 lies with the Nuclear Regulatory Comission and the 28 States that have entered into Agreements with NRC to regulate certain byproduct, source and special nuclear materials (See Appendix 3). The NRC's regulatory authority stems from the Atomic Energy Act of 1954, as amended and the Energy Reorganization Act of 1974, as amended. NRC's fundamental nandate for the use of these materials under the Acts is to provide adequate protection of the public health and safety and to prevent an unreasonable risk to the common defense and security. Section 274 of the Act permits NRC to enter into agreements with qualified States whereby the States assume regulatory authority over most uses of byproduct, source and small quantities of special nuclear materials.

NRC and the Agreement States collaborate in developing regulatory standards and programs. In practice, NRC frequently assumes the lead in drafting licensing and inspection guides for radioactive materials regulation. The Agreenent States currently regulate 60% of the over 20,000 specific licensees issued in the United States for radioactive materials and NRC staff values their experience and seeks their counsel.

In tura, NRC staff provides radiation safety training as well as case-specific technical assistance to the Agreement States.

State-to-State assistance also occurs.

I For the purpose of this report, the term "large irradiator" means wet source storage irradiators which typically use kilo or megacurie quantities of radioactive material. Shielding is typically provided by

.' a water pool or a combination of pool and engineered structures.

(FootnoteContinued)

The application of ionizing radiation to alter the characteristics of materials (such as sterilization) has been an evolving one. Currently, the larger licensed facilities typically utilize megacurie quantities of radioactive material. Shielding during storage is provided by water (which can also serve as a decay heat sink). Engineered structures (concrete enclosures) serve as shielding in facilities where the sources are raised from the pool to irradiate products.

Movement of the radioactive sou ce and of the product through the irradiation cycle may be governed by progrannable controllers or by computers.

Radiation safety standards specific to large irradiators have evolved as well. In the United States, radiation safety standards and guidance have been prepared by the American National Standards Institute and by NRC(1-3). Generally applicable radiation safety requirements have been established by NRC in 10 CFR Parts 19 and 20 and by the Agreement States in equivalent State regulations. NRC staff has also develoned general guidance for inspections of materials licenses which would be applicable to inspections of large irradiators (4-7). Regulations that are applicable to the transportation of the radioactive sources (e.g., to deliver then to the irradiator) have been issued by NRC ano the U.S.

Department of Transportation (8,9).

Operating experience, overall, has been good but sone problems have occurred. In the United States, there have been two incidents involving accidental overexposures to radiation received from irradiator sources, both prior to 1975. In both cases, the exposed individuals were employees of the irradiation facility and they survived the exposures.

In 1982 an incident occurred at an irradiator in Norway and an exposed worker died from radiation injuries 13 days after the exposure (10-12).

Pool water contamination and pool integrity have occasionally become sources of radiological problems. In one case, an unlined concrete irradiator pool suffered radiation damage from Co-60 sources stored in close proximity to the pool wall and leakage of the pocl water, which was contaminated, crcurred. Corrective measures included adding a steel liner and instituting a ground water monitoring program. Pool water contamination ccn be caused by contact with shippicg casks and by source leakage. Pool water contamination has occurred and, when significant, greatly complicates operaticns and can seriously and adversely affect costs that are incurred when a tccility is decommissioned. Co-60 source integrity experience has largely bean satisfactory; further, the consequences of leakage of Co-69 sources are somewhat mitigated by the relative intolubility o netallic d

Co-60 in water. Such is Oot the case with the Cs-137 sourcet being made available from DOE. For thcse sources, sotrce integrity becomes critical since the Cs-137 is in a highly soluble chloride form. The consequences of a Cs-137 leak ccn (Footnote Continued)

American National Standar!s Institute N43.10 Categories III and IV irradiators are included.

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t become more serious in terms of relative concentrations of radioactivity in the pool water, increased radiation levels within the plant and contaminated materials and facilities that be dealt with in decommissioning the plant.

Development of siting criteria for irradiator facilities that deal with the associated risks and consequences of damage from site-specific environmental and natural phenomena that might cause loss of shielding integrity or otherwise affect the radiological safety of the facility has not received significant attention. Two licensed irradiators are located within 2 miles of a known, active geological fault and the State licensing agency evaluated the radiological consequences of an earthquake prior to approving the license. In 1985, a self-contained wet storage irradiator in Pennsylvania was struck by a tornado. In this incident, the roof of the building which was not a shielding structure was damaged, however, the radioactive sources and the pool water shielding were not affected.

Facility contaminatien and possible adverse natural phenomena can create problems that require extraordinary financial resources to solve, either immediately after the occurrence, or later when decommissioning occurs.

At present, NRC regulatory standards for financial and security arrangements do not exist for these types of facilities and the need for such requirements is being considered as part of NRC rulemaking on decomissioning and funds for cleanup after accidents.

In September 1985, NRC's Office of State Frograms, as part of its training program for Agreement States, sponsored a workshop on large irradiator radiation safety. 48 Federal and State regulatory program representatives gathered at Rutgers University's Continuing Education Center to review past regulatory experiences and present regulatory stardards for radiation safety for large irradiators. The workshop included a visit to a recently NRC-licensed state-of-the-art irradiator nearby. Workshop participants then divided into smaller working groups to specifically address the following regulatory matters:

o What should be the key elements of a large irradiator license application review?

o Is there a need for a construction QA and inspection program?

o Should irradiator source loading be covered in a regulatory inspection program?

o What should be the key elements of preoperational inspections?

o What should be the key elements of routine inspections?

The workshop groups were asked to determine what radiation safety issues a regulatory agency should look at, identify presently available standards and. guides (see Section 4, References) and, as appropriate, make recommendations for developing additional guidance. Consensus views were to be sought but provisions were also made for airing

's differing professional opinions. The results of the working gW Jps Were presented and discussed on the last day of the workshop, This workshop report is not intended to be a definitive statement of regulatory requirements nor does it represent the regulatory positions of any of the participating agencies. It should be emphasized that a considerable body of regulatory requirements and guidance as well as guidance from voluntary national standards groups exist that are applicable to large irradiators and have, overall, been successful in assuring the safe use of there facilities. We remain sensitive, however, to the need for improvements in our standards and try to profit from our regulatory experience and to share our insights. It is in this spirit that the workshop was sponsored and this report was prepared. In this context, this report records the thinking on specific issues by licensing, inspection, supervisory and management staffs from agencies charged with protection of public health and safety. As such, we hope it can serve in conjunction with the references in Section 4 as a sourcebook on radiation safety considerations for large irradiators for designers, operators, regulators and for persons involved in the development of standards.

All of the workshop participants would welcome further discussion of the issues of radiation safety for large irradiators. Readers are invited

. to share their views and comments by writing the authors:

Joel 0. Lubenau Donald A. Nussbaumer Office of State Programs U.S. Nuclear Regulatory Commission Washington, D.C. 20555

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i l 2. WORKSHOP REPORTS i

2 2.1 Key Elements of License Application Reviews ,

4 The basis for the workshop discussion on license application reviews was the NRC Standard Review Plan (SRP) (2). The workshop did not make any recommendations for deletions from the SRP but did identify additional i areas which an application should cover, or where guidance is needed, or l in some cases, where regulatory requirements are needed. The following is a list of these areas. The items were not ranked in order of l priority.

o Infomation should be sought on the applicant's ability to financially handle decontamination and decociaissioning costs.

Guidance for evaluating such infomation is needed.

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o Requirements for radiation safety training for users, supervisors and persons responsible for radiation safety

should be spelled out by regulation using, as an appropriate

model, the requirements for training of radiographers and i radiographers' assistants contained in 10 CFR Part 34.

' Training must include instruction in site-specific operating and emergency procedures.

r i o A " responsible person" should be present on-site at all times (of operation) and this should be required by regulation.

o The NRC license guide and application should discuss the irradiator safety control sgtems. Their interface with computer controls (e.g., extent of control, hard wiring etc.)

should also be described.

1 o When computers control safety systems, there should be quarterly independent verification of the proper operation of l the safety systems to assure that if a malfunction occurs, the

computer will recognize and report the event.

I o The license application should specify the conditions that will trigger a change of the source position to a shielded i

position from an unshielded position, and conversely, what

conditions must be met to permit changing from a shielded to j unshielded position.

l o 10 CFR 20.203(c)(6) reads:

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-6 (6) Each area in which there may (11) Be equipped with additional con- (v) Be controlled by use of such ad-exist radiation levels in excess of 500 trol devices such that upon failure of ministrative procedure and such de-rems in one hour at one meter from a the entry control devices to function vices as are necessary to assure that as required by paragraph (cX6MD of the area is cleared of personnel prior sealed radlo-active to irradlate materialssource shall.thst

is used this section the radiation level within to each use of the source preceding the area, from the scaled source, shall which use it might have been possible (1) Have each entrance or access be reduced below that at which it for an individual to have entered the point equipped with entry control de- would be possible for an individual to s.res.

vices which shall function automati- receive a dose in excess of 100 mrem in (vi) Be checked by a physical radl-cally to prevent any individual from inadvertently entering the area when one hour; and visible and audible allon measurement to assure that such radiation levels exist; permit de* alarm signals shall be generated to prior to the first individual's entry liberate entry into the area only after make an tndividual attempting to into the tres after any use of the a control device is actuated that shall enter the area aware of the hazard source, the radiation level from the cause the radiation level within the and the licensee or at least one other source in the ares is below that at individual, who is famillar with the oc-area, from the sealed source, to be re- which it would be possible for an indl.

duced below that at which it would be tivity and prepared to render or vidual to receive a dose in excess of summon assistance, aware of such fall.

possible for an individual to receive a ure of the entry control de/ces.

100 mrem in one h0ur.

dose in excess of 100 mrem in one (tit) Be equipped with control devices (vil) Have entry control devices re-hour; and prevent operation of the quired in paragraph (cx6XI) of this such that upon failure or removal of source if the source wou?d produce ra- physical radiation barriers other than section which have been tested for dlation levels in the area that could the source's shielded storage container proper functioning prior to initial op-result in a dose to an, individual in the radiation level from the source erstion with such source of radiation excess of 100 mrem in one hour. The shall be reduced below that at which it on any day that operations are not un-entry control devices required by this Interruptedly continued from the pre-would be possible for an individual to s

paragraph (cM6) shall be established receive a dose in excess of 100 mrem in vious day or before resuming oper-in such a way that no individual will one hour; and visible and audible ations after any unintended interrup-be prevented frorn leaving the area. alarm signals shall be generated to h 'd tes, t e , an ul of

'This parasraph (cNel does not apply to mah WMaW aMM M%sh sware of the hazard and the licensee tests of function No operations other radioactive sources that are used in tele.

therapy. In radiography, or in completely or at least one other individual, who is than those necessary to place the self shleided irradiators in which the source familiar with the activity and pre- source in safe condition or to effect re-parts on controls shall be conducted is both stored and operated within the same pared to render or summon assistance, shelding radistton barrier and in the de- gware of the failure or removal of the alth such source unless control de-signed configuration of the irradiator is physical barrier. When the shield for vices are funcuonW perly. De gg-always physically inaccessible to any ind6- censee shall submit an acceptable vidual and cannot create high levels of radt-the stored source is a liquid, means shall be provided to monitor the integ- schedule for more complete periodic auon In an area that ts accessible to any in- tests of the entry control and warning dividual. This paragraph (cM61 also does not rity of the shleid and to signal, auto- systems to be established and adhered apply to sources from wh6ch the radiation is matically, loss of adequate shielding, incidental to some other use nor to nuclear Physical radiation barriers that com- to as a condit!on of the license.

reactor sencrated radiation other than radt- prise permenent structural compo-ation from byproduct, source. or spectat nu- (vill) llave those entry and exit por-clear materials that are used in scaled nents, such as walls, that have no tals that are used in transporting ma-credible probability of failure or re-terials to and from the irradiation Nr e en ply after a r. 14.

197s. Each person licensed to conduct activg.

moval in ordinary circumstances need area, and that are not intended for use not meet the requirements of this by individuals, controlled by such de-ties to which this paragraph (cM6e apphes paragraph (cM 6X111). vices and administrative procedures as and who ts not in compliance with the prost- (iv) Be equipped with devices that are necessary to physically protect and stons of this paragraph on Mar.14.191s.

shall file with the Director. Ofhee of Nucle-will automatically generate visible and warn against inadvertent entry by any ar Material safety and safeguards. t S Nu' audible alarm signals to alert person. Individual through such portals. Exit

" nel in the area before the source can portals for processed materials shall 2 S. on r o lunS 4 I 7s n: be put into operation and in sufficient be equipped to detect and signal the formation describing in detail the actions time for any individual in the area to presence of loose radiation sources taken or to be taken to achtete compliance operate a clearly identified control that are carried toward such an exit with this paragraph by Dec. 14.1978. and may continue activities in conformance with device which shall be installed in the and to automatically prevent such area and which can prevent the source loose sources from being carried out of present license conditions and the provi- from being put into operation.

stonA of the preilously effective 5 20 2034 the area-untti such compilance is achtesed. For such persons compliance must be achieved not later than Dec.14.197s.

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Overall 10 CFR 20.203(c)(6) may benefit from re-review and editing to improve clarity and intent. Specific examples follow.

- With respect to this section, the distinctions between

" inadvertent" and " deliberate" entry into High Radiation Areas has clouded the central issue which is: Can an individual gain access to the High Radiation Area?

Also, in this context, the term " access point" needs to be defined. What constitutes accessibility?

- With respect to 10 CFR 20.203(c)(6)(ii), in facilities where the source must move from an unshielded position to a shielded position, how fast must it move to meet the requirement? In some facilities, it may be possible for an individual entering the irradiator to reach a High Radiation Area because of the time it takes to lower the source rack to a full shielded position. This needs to be addressed, where applicable, by applicants and perhaps by the regulations.

- With respect to 10 CFR 20.203(c)(6)(vii), clarification is needed concerning the terms " interruption" and

" uninterruptedly continued." Is the source supposed to be in a shielded condition during an interruption? If so, why doesn't this subparagraph clearly state it?

o .The handling of ion exchange resins used for pool water treatment needs to be addressed with respect to shielding and disposal. In cases where resins are returned to suppliers for recharging and recycling what special considerations are needed concerning their future use on account of radioactivity that may have accumulated in the resins?

o More guidance is needed with respect to what water treatment systems effluents may or may not be discharged to the environment and under what conditions.

o With respect to water pools used for source storage and shielding:

-What does " water-tight" mean? Are there acceptable levels of leakage?.

-Stainless steel liners should be required, perhaps as a function of the amounts of radioactivity in the pool.

-Data is needed on corrosion and leaching of pool wall materials in the environments encountered in irradiator pools so that applicant proposals can be evaluated for adequacy.

o With regard to facility design:

-While facility blueprints can be helpful, facility sketches, especially these showing and identifying restricted, radiation and high radiation areas, should also be included in an application.

-Shielding calculations, and the assumptions used in them, should be confirmed during the license application review.

-A facility radiation survey (after construction) to confinn that design and regulatory objectives have been met is sufficiently important that it should be required by regulation.

-The application should specify the locations of heat and smoke sensors.

-Tne need for seismic switches should be discussed.

o With respect to radiation detection instruments:

-The applicant should describe the technical merits of hand held survey instruments, e.g., dead time and saturation. The importance of survey instrument limitations should also be covered in training such as it is currently required for radiographers.

-A QA program for fixed radiation monitors should be provided by the applicant.

-The emergency alarm description should spell out what alarms are activated, under what conditions and who is alerted.

-A continuous radiation monitor should be provided on the water treatment system.

-Performance specifications should be provided for radiation monitors.

o The following procedures were deemed to be sufficiently important that they should be specifically identified in the licensing guide as areas where the licensee will need to develop specific procedures:

-Source loading, including wipes of the shipping cask and flushing the cask with water and checking it for radioactivity.

-Design and use of source handling tools.

.g.

-Preventative maintenance for equipment installed within the irradiation areas and thus potentially subject to radiation

. damage.

-Emergency procedures. Emergency procedures should include considerations of site-specific design base accidents, such as tornados, earthquakes, etc.

-Advance briefing of local emergency agencies (fire and police) and hospital staff about the facility, its operations and needs for emergency assistance.

o Transportation activities should be carefully reviewed.

Training and procedures will need to be developed by the applicant for this aspect. Many sources (particularly Cs-137) will be shipped from 00E and licensees should have a program that will assure that NRC & D0T transportation requirements will be met as well as DOE requirements.

2.2 Construction QA and Inspection o Applicants should identify key systems that are important to health and safety and indicate how they will verify that the systems will be constructed and installed according to plans and specifications submitted in their applications. Examples of key systems are engineered structures (e.g., shielding), alarms and safety systems, controller programs and computer software, and the hard wiring supporting the systems.

o Checks should be made by the licensing agency to determine that the licensee has implemented a program for verifying construction and installation of safety systems.

o While no final consensus was expressed, the discussion of construction QA raised the question of considering applying either a construction permit regulatory approach or one that prohibits construction prior to issuance of a license. This would parallel somewhat the NRC regulatory program for licensed reactor facilities but workshop participants expressed varying views on the need and suitability of this approach for large irradiators. Discussions centered around the balancing of additional resources that might be required to implement such a program against the need for assurances that no deviations from the plans that are significant from health and safety have occurred.

2.3 Loading Inspection o Loading should be preceded by a prelicense inspection. Some favor was expressed in issuing the license in stages. For example, if the results of a pre-license inspection are acceptable, a license can be issued authorizing loading of the irradiator.

2.4 Key Elements of Pre-Operational Inspections o Preoperational inspections should be conducted, preferably at the final phase of construction.

o The purpose of the inspection should be to have the licensee demonstrate performance of the radiation safety program including engineered components and systems, procedures (e.g., source receiving and handling) and training.

2.5 Key Elements of Routine Inspections o Specific guidance for inspections of large irradiators is needed.

o Routine inspections should include two types:

-Day inspections when the RSO is present and which would follow normal inspection practices.

-Inspections at other times, including late evening or "backshift" hours, which would focus on operations and interviews of personnel, including operators, o Key elements of routine inspections should include:

-Entrancemeeting(withmanagementwalk-through)

-A facility tour as soon as possible after arrival

-Review of status of interlocks, especially with respect to by-passes for maintenance or other reasons

-Review start-up and operating procedures through observations and interviews

-Review pool water quality program

-Review the radiation safety system through independent checks and tests

-Perform independent measurements. These should include:

verification of integrity of shielding water cleanup system pool water sample ventilation system wipes, including of ventilation ducts, pool deck and source handling tools provision of spiked water sample to licensee to verify his laboratory analytic test procedures

-Records review including source inventory internal audit results use and operating logs effluents interlock tests leak tests training and retraining personnel dosimetry surveys instrument calibration

-Review radwaste handling practices, including handling of used ion-exchange resins

-Exit meeting with management 2.6 Other Workshop Comments 2.6.1 - At several points in the workshop, there were expressions of interest in exploring the usefulness of applying probabilistic risk analysis (PRA) to evaluation of large irradiator radiation safety problems. As an example, could PRA help regulators (and applicants) determine if severe adverse natural phenomena needs to be considered in the design and operation of an irradiator and help assess the relative effectiveness of alternatives that may be proposed to protect the facility, the environment and the public from the consequences of damage to the facility? Another example cited was using PRA to help identify the key elements of safety systems that should be included in a licensee's construction QA program.

Workshop participants were not asked to specifically address PRA, but many were aware of it, and asked if the application of PRA to large irradiator radiation safety would be worthy of further consideration.

2.6.2. Along these lines a coment was also offered that we currently do not require applicants to include failure mode analyses of their safety systems. The need and usefulness of such infonnation for evaluating the ability of an applicant to meet standards for safety (e.g.,10 CFR 20.203(c)(6)) may deserve further evaluation.

2.6.3. Although the workshop was not asked to address resource requirements for implementing the recormendations, many of the workshop participants were acutely aware of and concerned over the resource implications of their recommendations either in terms of needs for special expertise (e.g., engineering or metallurgy) or total staff tine.

As a general observation, the recommendations reported herein should be viewed as sufficiently important to health and safety to merit consideration for inclusion in a regulatory program on their own merits.

In some cases, the workshop expressly identified the resource implications as a concern. Where this was the case, it has been so noted.

2.6.4. Many of the newer large irradiators utilize programmable controllers (PC's) or computers to control source and product movement and interface with the radiation safety system hardware. There was considerable discussion of the extent of knowledge needed by regulatory staffs of their functions. PC's use relatively simple logic and are easy to understand. Evaluation of computer software might require somewhat more advanced knowledge. Some workshop participants advocated a " black box" approach: Assume that it is performing its function and procede with checkouts of the physical components of the safety systems.

Others felt it was necessary to seek assurance that the system was properly designed and would continue to perform as designed.

The workshop participants were provided copies of AftSI standards that suggest some validation and verification procedures and documentation can be requested of applicants using PC's or computers (13,14). These could provide assurance that the PC or computer is " performing its

function" and enable an inspector to proceed with some confidence with checks of the radiation safety system hardware, including, when appropriate, testing the system through the PC or computer.

2.6.5 Operator fatigue, particularly as a result of long working hours, and other factors affecting operator oerformance was discussed. No consensus views were offered by the workshop on whether or not this should be a regulatory matter but it should be noted that operator fatigue was specifically identified by the Commission in its investigation of an irradiator overexposure as a factor that contributed to the cause of the accident.

3.0 APPENDIX

NRC AGREEMENT STATES Became an Agreement State On-10/1/66 Alabama 205-261-5313 Mr. Aubrey Godwin, Chief Bureau of Radiological Health Environmental Health Adninis.

Room 314, State Office Building Montgomery, Alabama 36130 5/15/67 Arizona 602-255-4845 Mr. Charles F. Tedford, Director Arizona Radiation Regulatory Agency 4814 South 40th Street Tempe, Arizona 85040 7/1/63 Arkansas 501-661-2301 Mr. Frank Wilson, Director Div. of Radiation Control and Emergency Management Arkansas Dept. of Health 4815 West Markham Little Rock, Arkansas 72201 9/1/62 California 916-445-0931 License Insp.

Mr. Joe Ward, Chief - 916-322-2073 Radiologic Health Section Department of Health 714 P Street, Room 498 Sacramento, California 95814 2/1/68 Colorado 303-320-8333 Ext. 6246 Amended Mr. Albert J. Hazle, Director 4/20/82 Radiation Control Division Office of Health Protection Department of Public Health 4210 East lith Avenue Denver, Colorado 80220

7/1/64 Florida 904-487-1004

Lyle E. Jerrett, Ph.D., Director Office of Radiation Control Dept. of Health & Rehabilitative Service 1323 Winewood Blvd.

Tallahassee, Florida 32301 12/15/69 Georgia 404-894-7610 Bobby G. Rutledge, Director Radiological Health Section Department of Human Resources Room 600 878 Peachtree Street Atlanta, Georgia 30309 10/1/68 Idaho 208-334-4107 Mr. Robert Funderburg, Sr pert isor Radiation Control Sectio ~.

Idaho Department of Health and Welfare Statehouse Boise, Idaho 83720 1/1/86 lowa 515-281-4928 Mr. John A. Eure, Director Environmental Health Section Iowa Department of Health Lucas State Office Building Des Moines, Iowa 50319 1/1/65 Kansas 913-862-9360 Ext. 284 Mr. David Ramono, Manager Bureau of Air Quality and Radiation Control Dept. of Health & Environment Building 740, Forbes Field Topeka, Kansas 66620 3/26/67 Kentucky 502-564-3700 Mr. Donald Hughes, Manager Radiation Control Branch Dept. of Health Services Cabinet for Human Resources 275 East Main Street Frankfort, Kentucky 40621

1 5/1/67 Louisiana 504-925-4518 FTS-687-0598 Mr. William H. Spell, Administrator Nuclear Energy Division Office of Air Quality & Nuclear Energy P. O. Box 14690 Baton Rouge, Louisiana 70898 1/1/71 Maryland 301-225-6984 Mr. Robert E. Corcoran, Chief Division of Radiation Control Dept. of Health and Mental Hygiene 201 W. Preston Street Baltimore, Maryland 21201 7/1/62 Mississippi 601-354-6657/6670 Mr. Eddie S. Fuente, Director Division of Radiological Health State Board of Health Felix J. Underwood Building 2423 North State Street P. O. Box 1700 Jackson, Mississippi 39205 10/1/66 Nebraska 402-471-2168 Mr. Harold Borchert, Director Division of Radiological Health State Department of Health 301 Centennial Mall South P. O. Box 95007 Lincoln, Nebraska 68509 7/1/72 Nevada 702-885-5394 Mr. John Vaden, Supervisor Radiological Health Consumer Health Protection Services Room 103 Kinkead Bldg.

Capitol Complex Carson City, Nevada 89710 5/16/66 New Hampshire 603-271-4587 Hs. Diane Tefft, Program Manager Radiological Health Program Bureau of Environmental Health Division of Health Services Health & Welfare Bldg., Hazen Drive Concord, New Hampshire 03301

5/1/74 New Mexico 505-827-2939 Mr. Michael Brown, Acting Chief Radiation Protection Bureau Environmental Improvement Div.

Department of Health and Environment P. O. Box 968 Santa Fe, New Mexico 87504-0968 10/15/62 New York 518-474-2178 Mr. Jay Dunkleberger, Director Bureau of Nuclear Operation New York State Energy Office Agency Building 2 2 Rockefeller Plaza Albany, New York 12223 8/1/64 North Carolina 919-733-4283

, Mr. Dayne H. Brown, Chief Radiation Protection Section Division of Facility Service 701 Barbour Drive Raleigh, North Carolina 27603 9/1/69 North Dakota 701-224-2348 Mr. Dana Mount, Director Div. of Environmental Engineering Radiological Health Program State Department of Health 1200 Missouri Avenue Bismarck, North Dakota 58501 7/1/65 Oregon 503-229-5797 Mr. Ray Paris, Manager Radiation Control Section Dept. of Human Resources 1400 South West Fifth Avenue Portland, Oregon 97201 1/1/80 Rhode Island 401-277-2438 Mr. James E. Hickey, Chief Div. of Occupational Health and Radiation Control Rhode Island Dept. of Health Cannon Building 75 Davis Street Providence, Rhode Island 02908 I

l

9/15/69 South Carolina 803-758-5548 Mr. Heyward Shealy, Chief Buread of Radiological Health State Department of Health and Environmental Control J. Marion Sims Building 2600 Bull Street Columbia, South Carolina 29201 9/1/65 Tennessee 615-741-7812 Mr. Michael H. Mobley, Director Division of Radiological Health Department of Public Health Cordell Hull State Office Building Nashville, Tennessee 37219 3/1/63 Texas 512-835-7000 Mr. David K. Lacker, Chief Bureau of Radiation Control Amended Texas Department of Health 3/24/82 1100 W. 49th Street (nail only)

Austin, Texas 78756 4/1/84 Utah 801-533-6734 Mr. Larry Anderson, Director Bureau of Radiation Control State Department of Health 150 W. North Temple Box 45500 Salt Lake City, Utah 84145 12/31/66 Washington 206-753-3459 Mr. Terry R. Strong, Head Radiation Control Section Amended Department of Social and Health 2/19/82 Services Mail Stop LF-13 Airdustrial Park Olympia, Washington 98504

4.0 REFERENCES

Note: U.S. Nuclear Regulatory Comission (NRC) NUREG reports are available for purchase from the National Technical Information Service, Springfield, Virginia 22161. Other referenced NRC documents are available in the NRC PUblic Document Room at 1717 H Street, N.W.,

Washington, D.C. for inspection and copying for a fee.

1. American National Standards Institute, " Safe Design and Use of Panoramic, Wet Source Storage Gamma Irradiators," National Bureau of Standards Handbook 142, U.S. Government Printing Office, Washington, D.C. 20402,(July,1984).

2. U.S. Nuclear Regulatory Comission, Office of Nuclear Material Safety and Safeguards, Division of Fuel Cycle and Material Safety,

" Policy and Guidance Directive FC 84-23; Standard Review Plan (SRP) l for Applications for Licenses for the Use of Panoramic Dry Source -

Storage Irradiators, Self-Contained Wet Source-Storage Irradiators, and Panoramic Wet Source-Storage Irradiators" (Dec. 27,1984).

3. U.S. Nuclear Regulatory Comission, Office of Nuclear Material Safety and Safeguards, Division cf Fuel Cycle and Material Safety,

" Policy and Guidance Directive FC 84-25 Licensing of Large d Irradiators" (Nov. 28,1984).

J

4. U.S. Nuclear Regulatory Comission, Office of Inspection and Enforcement, " Inspection and Enforcement Manual, Licensed Materials Programs, Inspection Procedure 87100" (March 12,1984).

5. U.S. Nuclear Regulatory Commission, Office of Inspection and Enforcement, " Inspection and Enforcement Manual, Inspection Procedure 83822, Radiation Protection" (January 1,1984).

6. U.S. Nuclear Regulatory Comission, Office of Inspection and Enforcement, " Inspection and Enforcement Manual, Inspection Procedure 83890, Closecut Inspection and Survey" (November 8, 1983).

7. U.S. Nuclear Regulatory Comission, Office of Inspection and Enforcement, " Inspection and Enforcement Manual, Inspection Procedure 83895, Follow-up on Expired Licenses," (November 8, 1983).

8. U.S. Code of Federal Regulations, Title 10. Part 71, " Packaging and i Transportation of Radioactive Material," Office of the Federal Register, U.S. Government Printing Office, Washington. 0.C. (1985).

9. U.S. Code of Federal Regulations, Title 49 Parts 100-99,

" Transportation," Office of the Federal Register, U.S. Government PrintingOffice, Washington,D.C.(1985).

10. L. Berteig and J. Flatby, "The Radiation Accident at Institute for Energy Technology, September 1982, Some Technical Considerations,"

1 J. of Industrial Irradiation Tech. 2:309-319(1984).

i- 11. E. Sagstuen, A. Theisen, T. Henrikson, " Dosimetry by ESR spectroscopy following a radiation accident," Health Physics 45:961-968 (November,1983).

12. P. Stavem et al., " Lethal Acute Gamma Radiation Accident at Kjeller, Norway: Report of a case," Acta Radiologica Oncology 24 (1985).

13. American Nuclear Society Standards Committee Subcommittee ANS-10 "American National Standard Guidelines for the Documentation of Digital Computer Programs," American Nuclear Society, Hinsdale, Illinois, 60521, (June 20, 1974).

14. The Institute of Electrical and Electronics Engineers. Inc.

Standards Board, "IEEE Standard for Sof tware Quality Assurance Plans," IEEE, New York, N.Y. 10017(June 14,1984).

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Ei 7 BIBLIOGRAPHIC DATA SHEET u .it oct.o : o v. .....u NUREG/CP-0073 3 initi .>O sv.f sTL. 3L .tiet...

Proceedings of the Workshop on large Irradiator Radiation Safety .o..... o. co., tie o oo... ....

j a .u < o.is. November 1935

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March 1986

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State Agreements Program . ...c,. ... ...

Office of State Programs U.S. Nuclear Regulatory Commission Washington, D.C. 20555 io .,om ..o o. .. 4.r.os .... ..o ...t. o .oo. u ,, i. c , ii.1,. o....o.,

Same as item 7. Regulatory e .. .iCo Cow i.io ##.res=e eso, 12 $U,,4....T..v 01 3 93 ...T..CT sJ0D seres ., .med T his document reports the results of an NRC-sponsored workshop on regulatory considerations for large (pool-type) irradiator radiation safety. The workshop focused on the following regulatory activities: licensing, construction QA, source loading inspection, preoperational inspection, and initial and routine inspections. Workshop participants developed consensus views on most of the key elements of each of these regulatory activities. The workshop report has been prepared to serve as a radiation safety reference sourcebook in conjunction with available national design standards, regulatory requirements and regulatory guides for irradiator designers and operators, regulatory staffs and for persons involved in developing safety standards for these facilities.

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