ML20058K320

Proposed Rules 10CFR19,20,21,30,36,40,51,70 & 170, Licenses & Radiation Safety Requirements for Large Irradiators

ML20058K320
Person / Time
Issue date:	11/27/1990
From:	Chilk S NRC OFFICE OF THE SECRETARY (SECY)
To:
References
FRN-55FR50008, RULE-PR-19, RULE-PR-20, RULE-PR-21, RULE-PR-30, RULE-PR-36, RULE-PR-40, RULE-PR-51, RULE-PR-70 PR-901127, NUDOCS 9012170138
Download: ML20058K320 (108)

Text

{{#Wiki_filter:. -.. - bCD. ' 6 [7590 01) DOCKET NUMBER PROPOSED RULE II /% 40,01 eTAL. txst;ce (55FR5ccog) %%c j '90 A'0V 29 A 9 :13 t NUCLEAR REGULATORY COMMISSI& 7s "T ci v m w v 10 CFR Parts 19, 20, 21, 30, 36, 40, 51, 70 and 170'M '.'M N

• k" RIN 3150 AC98 Licenses and Radiation Safety Requirements for Large Irradiators AGENCY:

Nuclear Regulatory Commission, i ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory Commission is proposing to amend its regulations by establishing a new Part 36 to specify radiation safety requirements and licensing requirements for the use of licensed radio-active materials in large irradiators. Irradiators use gamma radiation to irradiate products to change their characteristics in some way. The safety requirements would apply to large panoramic irradiators (those in which the material being irradiated is in airs in a room that is accessible i to personnel when the source is shielded) and certain large underwater irradiators in which the source always remains shielded under water and the product is irradiated underwater. The rule would not cover self-l contained dry-source-storage irradiator devices, instrument calibrators, medical uses of sealed sources (such as teletherapy), or nondestructive testing (such as industrial radiography). DATES: Submit comments by.(ninety days after publication in the Federal Register). Comments received after this date will be considered if it is practical to do so, but the Commission can assure consideration only for comments received on.or before this date. Ig\\* g21g138902127 F 19 55FR50008 PDR i,; 1 J,

T 8 g A public meeting on"the proposed rule will be held on February 12 and 13, 1991, in Rockville, Maryland, i I ADDRESSES: Submit comments to:' The Secretary of the Commission, Washington, DC 20655, Attention: Docketing and Service Branch. Copies of comments received and documents referenced in this pro-posed rula may be examined at the NRC Public Document Room, 2120 L Street NW., Lower Level, Washington, DC. FOR FURTHER INFORMATION CONTACT: Dr. Stephen A. McGuire, Office of d Nuclear Regulatory Research, U.S. Nuclear Regulatory Comission, Washington, DC 20555 Telephone: (301)492-3757, or Mr. Steven L. Baggett, Office of Nuclear Materials Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone: (301)492-0542. [ To obtain further information on and to register for the public g l meeting contact: Ms. Jayne McCausland, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Comission, Washington, DC 20555, Telephone: (301)492-3643. SUPPLEMENTARY INFORMATION: . Table of Contents I. Large Irradiators. II. 'Need for a Rule. III. Review of Operating Experience. A. Radiation 0verexposures. B. Other Operating Problems, C. Inspection History. \\ 2 l 1 1 ,... -~., - -. ,..~,.:.

S.. i IV. Radiation Protection Philosophy. V. Reference Documents. VI. Public Meeting VII. Summary of the Proposed Requirements and The Rationale for Their Inclusion. VIII. Other Considerations. IX. Agreement State Compatibility. X. Finding of No Significant Environmental Impact: Availability. XI. Paperwork Reduction Act Statement. XII. Regulatory Analysis. I XIII. Regulatory Flexibility Certification. XIV. Backfit Analysis. XV. List of Subjects. XVI. Wording of the Proposed Amendments. I. Large Irradiators Irradiators use gamma radiation to irradiate products to change their characteristics in some way. Irradiators are used for a variety of pur-poses in research, industry, and other fields. Irradiators covered by this proposed rule are those large enough to deliver a dose exceeding 500 rads (5 grays) in one hour at a d htance of one meter. The proposed rule does not cover self-contained irradiator devices in which the volume being irradiated is totally inaccessible to people. Irradiators use either radioactive materials or electronic machines (x-ray machines or accelerators) to produce very high radiation dose levels. The NRC and Agreement' States regulate irradiators using~ radio-active byproduct materials. Electronic machine irradiators are regulated 3

n' by the Occupational Safety and Health Administration (OSHA) and States. I The radioactive materials generally cobalt-60 or cesium-137, are con-tained in sealed sources or capsules made of stainless steel to prevent-the spread of the radioactive materials. Most often the sealed radio-l active sources are stored in water pools when not in use,'although some irradiators use solid shields in which to store the sources. In order to irradiate products, the sources are usually lifted out of the pool or solid shield into the air. However, in some irradiators the products to be irradiated are..wered into the pool. For large commercial production irradiators, the.otal activity of the sources typically exceeds 1,000,000 curies (3.7 x'1018 becquerels), and the product-to be irradiated moves past the sources on an automated conveyor system. In 1988, roughly 85 percent of the capacity of large irradiators was used to sterilize disposable medical. products and. supplies such as' dispos-able rubber gloves and syringes. The past two decades have seen a slow but steady growth in the use of disposeble medical products. Prior to that time, hospitals had recurring problems'with biological cross-contamination (the spread of infection from.one patient to 'anotNer). An important cause l of cross-contamination was the incomplete sterilization of certain medical products such as rubber gloves and syringes. The use of disposable pro-ducts was found to greatly diminish the extent of the problem. For years, sterilization of 'm'edical products was done primarily with l heat or the chemical ethylene oxide. Ethylene oxide was used for some products that could not be satisfactorily. sterilized with heat because the product would be damaged. -In 1978, the EPA declared that ethylene. oxide was a mutagen, possibly a carcinogen, and that its use should be carefully reviewed. Ethy?"ie oxide residues on products thus began to be of greater 4

I 1 \\ concern.- In 1984, OSHA established a new workplace exposure limit for f ethylene oxide that' lowered the acceptable level from 50 parts per million in air to 1 part per million, making its-use more difficult. These changes placed the use of ethylene oxide under regulatory constraint. As a result, sterilization by-gamma irradiation became the only viable alternative for sterilizing those products-that would.be damaged by heat'- 1 p In recent years the increasing incidence of Acquired Immune Deficiency Syndrome (AIDS) has increased the-demand ~for disposable medical L j products. Combined, these factors have led to a gradually increasing-use _of gamma radiation in the sterilization of medical. products. Most of the remaining irradiation processing capacity-is used for chemical processing, primarily the induction of polymerization in.plas-i. tics. A small amount of irradiator capacity is used for-research on.the L effects of very high doses of radiation, the'productio'n of sterile male j l insects for insect eradication programs, ~and other specialized.uses. l The Food and Drug Administration ~has, approved the'use of gamma l irradiation for the' disinfestation and preservation of foodstuffs (21' CFR 179.26). Any food may be' irradiated up to 100,000 rads-(1,000 grays) for i the purpose of disinfestation, such as to_ kill insects and parasites. Any fresh food may be irradiated up to 100'000 rads.(l'000 grays) toainhibit-growth or maturation, which thereby reduces' spoilage, Pork-may be-irradi-i- ated up to 100,000 rads (1,000 grays) to kill-the organisms that cause H e L trichinosis. Dry and-dehydrated foods may be irradiated up:to 3,000,000 r rads (30,000 grays)'for microbial disinfection. Thus, irradiation.is an L alternative to chemical preservatives and can reduce the use of pesticides ~ \\ lt and fumigants to control insect infestation of foods. L l l Presently there is very little preservation'of food by irradiation c 1 l -done.in the United States. Congress,- however, supports food irradiation 5 i j + r -.A

a L o \\ and has appropriated money to the Department'of Energy (DOE).to support L L the construction ~of six food irradiators. -There are other potential-uses'of irradiation'.- Irradiation can. sterilize biomedical wastes from hospitals. Currently, potentially infectious wastes are 'usually incinerated; Another potential use-is the ' I sterilization of toilet wastes,from airplanes and ' ships that arrive from abroad. Laws; require that1those wastes must be considered disease-bearing and-that they be sterilized. Currently, the wastes'are usually sterilized by' incineration'. Anotherpotentia'luseisthesterilizationoflsludgefromsewage'-

plants. ' Sludge could be used asia fertilizer if the pathogens in it were known to ~be killed and if concentrations.of certain heavy "etals and~

toxic chemicals were= low enough. Irradiation could kill ~.the pathogenic organisms but would have no.effect on; heavy metals or_ toxic chemicals. 1 With so many different uses and:potentiol uses,. irradiator' designs-are varied to suit specific. applications; Therefore, it:is desirable'to establish basic criteria to ensure alhigh standard of radiation safety-in the design and use of;irradiators. However, this'should.be accomplished ,in a way that does not unnecessarily restrict the: logical.use and growth of,their applications; Because of the. variety cf-designs, four gener:1 categories of 1 irr6diators have been defined by the American National-Standards Institute (ANSI).. The categories are as follows: Category I -- Self~ contained, dry-source-storage -irradiators. This ty;.e of irradiator is built as a self-contained device'. The sealed' sources are completely enclosed within-a shield constructed of solid materials. Human access to the sealed source and to the space-y 6 ,,.,..,..,.3.,r,,- ,. ~,

s l l l subject to irradiation is not physically possible. The physical size of-thedevice,thespace' subject'toirradiation,thesourcestrength,orall three are generally not large. i This proposed rule does not cover self-contained dry-source-storage- ~ irradiators-(Category I) for several reasons. First, they are devices 4 th'at the licensee usually purchases without: playing any part in their. design and manufacture.- Also, because safety features are designed into them, self-contained irradiators present less potential. hazard and they.. are considered to be adequately dealt with by existing requirements. This ] type of irradiator (Category I)lwould conti.,ue to be licensed under thel ~ general requirements of 10 CFR'30.33 using.the criteria in Regulatory Guide 10.9, Revision 1, " Guide for the Preparation of Applications for Licenses for the Use of Self-Contained Dry Source-Storage Irradiators," December? 1988, and also " Standard Review Plan for-Applications for Licenses for-the Use of Self-Contaired Dry Source-Storage' Gamma Irradiators," December i 1988. Category II.-- Panoramic, dry source-storage irradiators.- This. category includes irradiators in which the sealed sources are stored in a shield constructed of s'olid materials.and are-fully shielded i when not in use. Irradiations occur in air within a room accessible to personnel only while the sources are shielded. This category.also includes'certain beam type irradiators in which the source. remains par-l tially shielded. Irradiators of this. type are covered by the-proposed-rule. L 7-n L

Category III - Underwater-irradiators. This category includes irradiators in'which the sealed sou'rces are { always in a storage pool and are, shielded at all times. Human access to thesealedsourcesandthespacesubjecttoirradiationisnotphysically -possible. Irradiators of this type are covered by the proposed rule. i i Category IV -- Panoramic, wet-source-storage irradiators.- i This category includes irradiators in which the' sealed sources:are -in a storage pool containing water and are fully shielded.whenlnot in use. Irradiations occur in air withinia room made inaccessible to person'nel by j an entry control-system while the sources'are exposed.- Ir_tadiators'of 1 this type'are covered'by the proposed rule. i II. Need for a Rule' Large. irradiators are currentlyJ11 censed primarily, un' der:: (1).the general provisions of 10 CFR 30.33, which requires that:" equipment and -i i facilities are adequate" and that the " applicant.is' qualified by. training and experience;" (2) the general requirements of:Part 20, for example,- dose limits and the need for '" adequate" surveys; and.(3) the specific requirements in 10 CFR 20.203(c)(6):and;(7)Lthat dea 1{with access control .I requirements for panoramic irradiators._ There is also a draft regulatory- ~ ~ guide FC 403-4, " Guide for the Preparation of' Applications.for Licenses for the Use of Panoramic Dry Source-Storage Irradiators, Self-Contained Wet Source-Storage-Irradiators, and Panoramic Wet Source-Storage Irradia-tors," that was published in January 1985. However,.the scope of.the guide s E is limited, and many subjects are not covered or are-covered-in a way now 8 s a ,,...w.- ....O-e L

1 g ~ - considered obsolete. On subjects that are not covered in the regulations I or guide or for which there are no criteria on what'is' acceptable, the l applicant-has no way of knowing what will be accepted.:- Similarly, the license reviewer may be uncertain about what should be required. If the license reviewer considers the application incomplete _or inadequate, he or she sends a " deficiency letter" to the applicant explaining what addi-tional information is needed. Review of the application is,not resumed l until a written response from the applicant has.been received. This can substantially delay issuance of a-license. Thus, although the. safety requirements and. policies are generally understood and agreed upon, they are contained in regulations,;a regula-tory guide, and specific licensing _ conditions. This rule.would consoli- ~ date, clarify,.and standardize the requirements far.~ current and future-irradiators. A rule would also make the NRC's licensing reviews..and inspections ( more efficient. If requirements are clearly stated;in a rule, license applications-could be shorter because there would be no need for appli-l cants to describe what they would do in areas covered by the rule. The NRC.could.then issue licenses with fewer license _ conditions. Inspections j would be more efficient because there would be a uniform set of require-L I ments. Atpresent,asidefrom'thespecificrequirements[in 5 20.203 on 1, access control, many requirements ~are those' committed to by the applicant. in its license application. ~ The word'ing of similar-requirements can: vary .slightly from licensee to licensee. This makes -the NRC inspector's job more difficult because h'e'or she must determine precisely what each licensee is committed to doing. 9~ 8 ~ .-r n-w w+ie-+1 y ,e + .v y, j

r. There are at this. time a number of new large irradiators either under' construction or planned. In' addition, Congress has' appropriated money in support of the construction.of six food;irradiators. Thus, a significant-expansion in-irradiator operations is expected. Developers of.these new facilities may'not be familiar with NRC requirements.. A rule would help. l make NRC's requirements clear ~to people building'new irradiators. L .There are also some areas in which either. technology-.is changing: L (such as computer controllers) or;NRC! policy.is evolving.(such as quality t assurance).' A rule can provide. comprehensive and up-to-date-require-ments in these. areas that'would be consistend y and uniformly applied. In' addition, there were ainumber of; lessons learned from a-leaking ) source accident that occurred at an irradiator operated by. Radiation Sterilizers, Inc'. in Decatur, Georgia,.in 1988. An analysis:of the.-inci-dentandadiscussionofthelessons'learnedappear[.in.the-reporttitled " Leakage of an'Irradiator Source - The' June 1988 Georgia RSI Incident," NUREG-1392. One lesson learned was.a need for detailed emergency plans. The NRC agrees that there is a need-for plans to deal'with emergencies. The proposed rule contains a detailed _ list of emergency and: abnormal-events for which the licensee must have a written' emergency procedure ($.36.53(b)). The' procedures must be described in the license application ($ 36.13(c)). Operators must be trained in the. procedures ($ 36.51(a)(4)- and (g)) and must participate in an emergency drilleannually ($ 36.51(d)). l -Another lesson learned was the importance of proper training..The NRC-believes.in the.importance of proper training =for irradiator operators and the radiation safety officer. The proposed rule contains a detailed a description-of the training that an operator must receive'($ 36.51). The license application must describe the training program for: operators and 1 10 .... ~.. ,-..,-~.,.<g,-,5we w ,,ww

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i the qualifications of the radiation safety officer. These would then be evaluated by NRC on a case-by-case basis. -The proposed rule also would require drills of the' emergency procedures-($ 36.51(d)(6)). Specialized training in. decontamination would not be required because decontamination, if extensive, should be done by specialists ~who are experienced in decon-tamination work rather than by irradiator personnel. Thus, the proposed rule would require that decontamination be done by'a. licensee authorized. to do that type or.nrk.($ 36 59(d)). Included in the report was a recommendation for a " Community Relations-Plan"'to deal with public concerns. -The'NRC does not believe-that a " Community Relations Plan'! is' necessary in order to protect public health:and safety, although such a plan could be useful to a licensee for other reasons. Therefore the rule does'not' address the' issue of the need for such a plan. The rule does, however, require operating and emergency s procedures. Another lesson-learned is'that the license application should be: received early in the process,of building'an-irradiator. The NRC agrees

i with a need for.early notification.

The proposed rule would prohibit' the q start of construction of an irradiator b'efore a: license has been issued i ($36.15). - An issue raised in the report focused on whether WESF capsules.should be used in commercial irradiators'because. cesium-137 chloride;is highly soluble in water. The NRC b'elieves:that these questions on the "WESF" capsules cannot be-resolved until.the cause of the leak-is.better under-1 stood. However, as a practical matter, only two irradiators have used - "WESF" model capsules in the frequent-air-water. cycling mode, and neither of these irradiators now use "WESF" capsules. One.irradiator still uses 11 L N,

J 4-- the "WESF" capsules in a cycling mode, but the operation of the irradiator is such that the cycling is presently seldom done.. Also of concern was the detection of-contamination on workers'before they leave the facility. In the RSI accident,:some contamination was carried offsite, although the radiation doses involved were low in-com - 1 parison with NRC's dose limits.- Monitoring.of workers,after a leak has. been detected is;important. :Thus, the. proposed-rule would require that the licensee have a written emergency procedure for _ dealing with a leaking : l source or contamination (S. 36.53(b)) and1that the licensee promptly check j personnel for radioactive contamination ($,36.59(d)). ' Workers would have to be trained in the procedure ($L36.51(a)(4)). Another' issue dealt'with monitoring. irradiated product'for contami-nation.- In the RSI accident,;there was' concern that product that had been ~ irradiated after the leak started.could be contaminated.. The licensee's

record system allowed prompt tracking of 'all recentlyJirradiated product.

One shipment that had been shipped earlier in the day on which the leak-was detected was found to be contaminated. It was immediately recalled s and disposed of as radioactive waste... The lessons?1 earned-report recom-mended adequate monitoring systems for assuring uncontaminated packages,. and it perhaps implied that routine monitoring:of packages should'be done, i The NRC believes that there should be:a;means'of promptly detecting leak ' i 'ing= sources. The NRC believes'that the most: suitable way'to accomplish i this is with frequent monitoring of pool water, and thus the; proposed rule contains that requirement ($ 36.59(c)). The NRC agrees that if a leak:is I detected, all recently irradiated product must promptly be tracked and 9 L monitored for contamination. Thus, the proposed rule contains a require-h L ment to monitor irradiated product for{ contamination if~a leak occurs i ($ 36.59(d)).- i \\. 1- -.. [j o, +,- ..-..-.J ,.r.. ..m. .-,,_.t

i - 1 III. Review of Operating Experience j To develop a basis for these proposed safety requirements, the'NRC reviewed the operating experience of-large irradiators. The information-l; presented in this section-is taken, in large part, from " Review of Events-i at large, Pool-Type Irradiators," Eugene A. Trager, Jr., NRC Office for Analysis and Evaluation of Operating Data, NRC Report NUREG-1345, 1989.- (Copies of NUREG-1345 may be purchased through the U.S. Government Print-ing Office by calling (202) 275-2060' or:by writing'to the-U.S. Government. Printing Office, P.O. Box 37082, Washington, DC 20013-7082. Copies may-. also'be purchased from the National Technical Information Service, U.S. Department of Commerce, 5285 Port Royal' Road, Springfield, VA 22161.) A. Radiation Overexposures. Serious radiation overexposures. involving irradiate'* occurred in the U.S. in 1974 and 1977. Fatalities were caused by radiation overexposures s involving irradiators in Italy in 1975,1in Norway in 1982, in El Salvador in 1989, and in Israel in 1990.- i -In 1974, in New Jersey, an operatorfat a panoramic irradiator walked into the radiation room containing an exposed source, saw it,-.snd quickly left the room. He received a dose large enough to cause clinically observ-able symptoms of radiation sickness, but the-dose was not large enough to L be fatal. The entrance to the roosi' lack'ed the mcdern automatic access con-l h trol systems now used'and an: alarm system had been. turned off. The opera-tor did not follow.the proper procedures for entry.- It is possible the j operator was'not sufficiently vigilant because he_was working alone at a L late' point in his shift. The operator made the error on the twelfth hour i of the fourt'h straight day in which he worked 10 to 12 hours. 13 4 F'- s 1 w

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j In 1977, a worker at .another.irradiator-.in New Jersey _was-overexposed to radiation after he entered a radiation room while a 500,000-curie (1.8 x 10l bbecquerel) cobalt-60 source was: unshielded. The licensee j - was in the process of modifying the irradiator. and was-operating the. irra- .diator while the interlocks _on the door ~used~to prevent' entry.into_the.- ] radiation room were deactivated.'- In addition, construction activityfcaused the source-up warning light to be obscured from view. 1The door tolthe room 1 was open, and the worker, who assumed the. sources-were shielded.: entered ~ ~ the radiation room. Upon noticing that'the' sources were in the exposed position, the worker immediately left'the room'and notified his supervisor. Altho' ugh.not fatal, the worker's dose was calculated by the-licenseezto-be. between 150 and 300 rems to the whole body.; Subsequent tofthe? accident,- - the NRC adopted access control requirementsT(10 CFR 20.203(c)(6)) that required a backup warning system to warn anyone: attempting.to_ enter.:the radiation room while.the source is'unshieldedh In 1975 an accident occurred in Italy ata:30~,000-curie (1;1'x'1015-becquerel) dry-source-storage irradiator used to irradiate-corn.1' An oper-q atorclimbedonto-aconveyorbelt;t'omakean'adjustmentandwascarried under the source while it wasJunshieldet. ' When the-operator'complaine'd of j severe pain in his head, his partner attempted to remove ~him from beneath e the unit. However, hisl partner ran'the conveyor forward rather than in i reverse and exposed the' operator'sLentire body to theLunshielded' source. 1 The operator died 12 days later. 4 In 1982, an accident occurred.in Norway. A-maintenance man entered - the radiation room of a Category'IV irradiator while:a 65,000-curie i (2.40 x 1015-becquerel), cobalt-60 source was unshielded, and received a lethal radiation exposure. The facility had two automatic locks on the 14-l

door to the room to prevent it'from being opened while the source was exposed. However, one lock had been previously disconnected because it was malfunctioning, and the other failed due to a broken microswitch. The ~ facility did not meet.the requirements in_the NRC's current or proposed rule because (1) opening the door would not automatically cause the source to become shielded, (2) there was no backup system to automatically cause. the source to become shielded upon entry if the primary door or barrier were passed, and (3) there was no alarm system to alert'the person enter-ing that the source was exposed.- In addition, several NRC operational i requirements were not met. In. total, at least six. levels'of protection a in NRC's current and proposed requirements'were not-provided. (The acci- [ dent is described in.more detail'in "The.-Radiation Accident at Institute for Energy Technology, September, 1982,.Some Technical Considerations," r 1.eiv Berteig and Jon Flatby, The Journal of Indu'strial Irradiation Technology, Volume 2, pages 309-319, 1984.) In 1989,.a fatality resulting from an'irradiator exposure occurred i in El Salvador. A movable rack ~ holding a-18,000-curie (6.'60 x 10 "- i becquerel) cobalt-60sourcewasjammed'inanunshieldedposition. An 1 operator bypassed safety systems and-entered the. irradiation chamber, along with two helpers, to free.the rack and lower the source back into a storage pool.. The three workers were exposed to high doses:and devel-9 I oped acute radiation syndrome..Although prompt. medical attention was effective in countering the acute effects, the legs of two of the men i had to be amputatede Six months after the accident, the operator died 4 as.a result of radiation-induced lung damage which was complicated by a [ lung injury sustained'during treatment (summarized from Croft, J., r i. Zuniga-Bello, P., and A. Kenne,ke, 1989, "The Radiological Accident in 15 + - -,, -,. - ~. -

!j d-i San Salvador," IAEA General Conference: Scientific Programme for Nuclear Safety, September. 28,1989). In 1990, a fstality occurred in Israel. Product being irradiated. jammed on a conveyor system. The -jam also' prevented ^%. radiation sources. from being lowered to the safe shielded position. ',clearthejam,the operator entered the radiation roomJafter bypassing the interlocks designed to prevent entry into the room while'the' sources were exposed. He-received -a. fatal radiation dose wichin a minute,or two'. B. Other Operating. Problems.' NUREG-1345 =ider'.ified forty five: events _ at;U.S.' irradiators of; j which forty-four had some.actua1 Lor.potentialesafety significanc'e. Only; two of. the events had actual'rather than potential { impact on the health- ~ and safety of the employees or'lthe public.; Of1the. forty-four events,- s - thirty-one involved the failure, malfunction,'or degradation in the per-formance of some:irradiatort system. These systems. include: access. con-- o trol, source movement mechanism (movement:and. suspension);. source encap-sulation; and pool.or water cleanup system. 'An a'dditionaliten events-1 stemmed from management. deficiencies.. Three-events involved r.aturall [ s phenomena and other site problessi 1. Access control. Tworadiationoverexposuresihvolvingaccesscontrolwerediscussed i in Section III.A. and will:not be.discussedtfurther-here. Both events occurred prior to implementation!of NRC'sLcurrent access control regula-tions in Part 20. A third event, reported [in 1978,- also-'involvid -the - access control system. 'It was discovered that' failure of'two door ( 16 'y -.a--..-.. . i.., _ -. - _' a _ i..--.__.-.--..-

l interlock switches would allow the source to move from the safe storage -to the exposed position'even if the door to the radiation room was open. 2. Source movement.- There were thirteen events that involved interference with source l movement and.six other events that involved the source suspension cables. There were insufficient data to specify a cause for five of the L thirteen events in which source movement was impeded. -In six of the thir-1 teen events, the product carriers interfered with the movement of the source rack. In one of those, the interference was' indirect; a box pusher. cyl.inder-created a short in a' cont'rol circuit res'ulting.in the tripping-of a circuit breaker in the control cipcuit. The source then preperly began lowering itself'into the-shielded position. But loss of the control circuit caused the loss of the source-down position sensor, and so the source cable drum continued to rotate and raised the1 source to the up position before the motor stalled. The. source had to beclowered manually. i 'There were two source-movement' events. involving lossJof source movement capability that had unique causes. ~At a research irradiator, interference between an. experiment and the source impeded movement of the source. Low temperatures at another'irradiator: caused freezing that L appears to have been responsible for preventing movement'of the source. l The thirteen events involving source movement ~were benign in that no l . radiation exposures resulted. But two of the events caused fires inside. o I i l-the radiation room. Two events resulted in individual sources coming loose.from the source rack..One event resulted in distortion of the. source rack; L There were six problems with source suspension cables. In three of l' the events, the cable broke. In two events, the cable frayed. In one 17: -.. ~ _. -, - _ _ ~...

.1 event, the cable came off its pulley. There were no radiation exposures caesed by any of these events..In two of the events'in which the cable-b'oke, there are indications of-some-deficiencies in maintenance practices ~. In one, the cable was.known-to be frayed,.in the-other, the cable had not o 1 been inspected for at least th'ree years. -l

3.

Source encapsulation. There have;been'four events.in'which the encapsulation of-the~ radioactive sources appears to;have faile~d. Asia result', the storage pool was! contaminated. In one case,'a fire caused byLa. welder early'in. the facility life resulted in.the-discharge of a fireLextinguisher into the pool water. Almost immediately'afterwards, radioactive contamination of the. pool' water was detected. 'The source'of.the contamination-was never-established. -In a second event, a source was ruptured in~1974 due to mis- ) handling.. An excessive contamination level in'the pool was not noted j until 1982 because the contamination stayed atithe. bottom of the pool. t late in 1976, an irradiator licensee determined that the cobalt-60 i i concentration in the water.of.a'research and development pool was slightly. elevated (to 0.0013 microcurie / milliliter:or 48 becquerels / milliliter). The licensee stated that the activity level may have been the resultxof surface contamination from a batch of cobalt 460-sources recently installed l L in the pool or activity from one s'ource th'at had a loose cap. Deminerali- ) zation of the pool water successfully reduced.the-activity of the pool-to' normal operational levels. The suspect source was isolated and returned i to the supplier.- The previously mentioned 1988 event at RSI involved the leakage of-j a cesium-137 source. This resulted in the= release of about.10 curies 18

4 L (3.7 x 1011 becquerels) of cesium-M7 to the pool. The event led to ( concerns that cont'aminated products might have= been shipped from the plant. Although no contamination was found on products that had been distributed to the public, contamination'was found on products that had been shipped to a warehouse and in workers! houses and a-car. l 4. Pool or water cleanup system integrity. There were three events that involved-pool: leakage or pool cleanup system leaks. In the case of the leaking pool,l the' existence of 'a high rate of water loss from the storage pool was noted by an NRC' inspector during an inspection. After discussions with the.NRC, th.e licensee agreed to repair the leak and monitor the rate.of pool leakage.~. -j u There were two evnts' involving leaks in pool. water purification .l systems..In one event, the piping on:the discharge: side of the purifica-tion system pump leaked.. Contributing factors.were that the piping was. suitable for cold temperatures while the' pool water tempe'rature was 120*F i and that the joints had recently been torqued..'The. leak developed when the irradiator was shut down for the weekend and there,was.apparently.no low pool level shut-off on the purification-pump. 'In the second eve't-n involving a pool purification system leak,Jaipipe b'roke'. Contaminated water spilled into the: facility and some:ran out'.of the building. Small amounts of contamination were later found:on the ground outside of.the building. g 5. Miscellaneous systems. 1 i There were two events that involved miscellaneous systems. The first' event involved problems with-timers. The second event involved malfunc- . tion 'of-pistons used to. engage: clutches in the product. conveyor system.. 19 i

k ~ 6. Management' deficiencies. Ten events involved management deficiencies. None of the events. ~ caused radiation exposurer'or radioactive contamination.L In.one, a dose distribution study that involved the stationary irradiation of paper,-a fire resulted from gamma heating of-the paper. The most common management deficiency was operating an irradiator without the operable access' control interlocks required by_10 CFR 20:203(c). Several events of_this type occurred at the same fa'cility. 7, Natural phenomena. .There were three events. involving natural-phenomena.or other site-problems. None had any significant impact. One.irradiator was struck by a tornado, but.the-safety of the. facility.was. unaffected. A:second irra-diator was about 1201km from the epicenter of-'a series of six' earthquakes of about 3.6 magnitude on the Richter ~ scale. The irradiator was inspected ~ 'by si. ate inspectors and found-to be undamaged. In a' third event,.there. was a-fire at an irradiator site in a_ building that was-separate from the d irradiator building. The building was-used'to store sawdust..The irra-diator suffered no damage. C. Inspection History. A review of inspection rewords from January 1, 1980, to December 31, 1987, for current NRC. licensees indicates roughly-the following types and a frequencies of violations of the regulations: i 20 o l, l

Violations at NRC-Licensed Large Irradiators, 1980-1987 Radiation overexposures....................... none Recordkeeping and posting violations.......... 12 Failure to perform tests,-inspections, or routine maintenance within required frequency.....................'............. 10 Operating without fully operable inter-locks or alarms............................. 6 Failure to calibrate, radiation instruments...................... 3 i Operator not on authorized list.............. 3 Survey instruments or personnel.dosim-eters.not:used or used improperly.......... 3 Repairs or operation without. proper authorization.............................. 2 i Miscellaneous > violations...................... 5 The most significantLviolations are those in which the irradiator was operated without fully operable interlocks or alarms. ' Interlocks and) alarms are an important part of the system of protection used to prevent serious overexposures.- 1 i IV. Radiation Protection Philosophy Based'on the review of operating experience,'the most important radiation protection objective'at a large irradiator is preventing anyone from enter _ing the irradiation room while the' source is exposed. An unshielded source at'a large irraEiator could deliver a' lethal' dose in less than a minute.- The NRC believes that-its' current access control requirements adequately address this problem. Since imposition'of the curru.t require-j r ments~in'1978, there have been no reported entries of personnel into an irradiator room while the sour::e was exposed. -However, this proposed rule would revise the access control requirements to Lincrease their clarity.

21 G

vv-t = s u---- w e -m +-- 4 .w--w e vv t- ) w-- e e,a*

g'. ' f The second most important rad'iation protection object he h avoiding _ excessive radiat' ion exposure due-to radioactive contamination from leaking, damaged, or contaminated sealed sources.- An underlying' assumption in.thi's rulemaking is that any. sealed so'urce could leak. _ Therefore, the proposed rule would require means of coping with leaks so that_ radiatio'n overexpo-sures to facility employees and to,the public are avoided, i The first step in avoiding radiation exposures,due to contamination l-is to prevent leaking sources. The proposed rule has clear specific-requirements on the encaps'ulationiof sealed sources. Experience:with-sealed sources manufactured to the standards in the proposed' rule has been good. While the-proposed: rule assumes thattany source can leak or be damaged,~1eaks-are rare. When leaks have occurred,;the-proportion'of materialinthe' source'thathasescapedhasigenerallybeen.lowwith(the exception of a few cases-in which cutting tools were'm_istaken.ly used to-cut sources open. .The second step in preventing excessive radiation exposures requires that.a means to detect leakage.in a timely manner be provided. For pool ~ irradiators, the proposed rule;would require radiation' monitoring of pool water. The monitoring should' allow' prompt detection'of anycleak of-signi-ficant size. For dry-source-storage irradiators, the rule would require-periodic leak tests of very high sensitivity.. Although the monitoring is not as fren,unt as for wet-source-storage sources, the greater sensitivity should allow detection of any problem, early enough.- The third step-in preventing excessive radiation exposures is to require a. stainless steel pool liner on all new. source storage pools to act as a barrier to keep water from leaking out of the pool. The proposed rule contains this requirement. 22

l The fourth step is to have procedures for' dealing with accidents or abnormal events. The proposed rule requires the licensee to.have those procedures. Since the proposed rule contains tr.ese features, the NRC believes that the requirements in the proposed rule are adequate to assure a very. low. likelihood that anyone inside or outside the facility would be exposed to radiation in excess of NRC's dose' limits.in-10 CFR Part:20.- V. Reference Documents The requirements-in the proposed rule are based, in part,.on recommendations and requirements in the. documents listed below: 1. Draft Regulatory Guide FC 403-4,'" Guide for the Preparation of Applications for Licenses for the Use'of Panoramic Dry Source-Storage D Irradiators, Self-Contained Wet. Source-Storage Irradiators, and Panoramic Wet Source-Storage Irradiators," January.1985. -(Hereafter: called the "IrradiatorLicensingGuide.")lDraftRegulatoryGuidesmaybeobtained without cost by writing:-. Director, Division of Information Support Services, USNRC, Washington, DC 20555. { 2. American. National' Standard N43.10-1984,," Safe-Design and Use of~ Panoramic, Wet Source Storage Gamma Irradiators.~(Category IV)," National Bureau of Standards-Handbook 142, 1984.. (Hereafter called the " ANSI Cate-gory IV' Standard.") This document may be purchased;for.$8 from: -American. ~ 4 National Standards Institute, 1430 Broadway, New York, NY 10018. l ^ 3. American National Standard N542-1977, !' Sealed. Radioactive -Sources, Classification," National Bureau of Standards Handbook 126, 1978. This document may,be purchased from: The Superintendent of Documents, U.S. Government-Printing Office, Washington, DC 20402. [ 23

r 4. Draft American National Standard'N43.12'(dated October 2, 1985), " Safe Design and Use of Panoramic-Dry Source Storage Gamma Irra~diators," unpublished. (Hereaf ter called the " ANSI Category II Stan' ard','.) To4 l d .obtain'a copy write-to: Ms. Jayne McCausland', Office of Nuclear Regula-j tory Research, USNRC, Washington, DC.'20555, - A 5. NUREG-1392, " Leakage of'an Irradiator Source - The June 1988 Georgia RSI Incident," February 1990. This-document may be. purchased from: The Superintendent of Documents, U.S. Government Printing Office, Wa nington, DC 20402. i VI. Public MeetihgL a e Because of the length and complexity of the propos'ad rule,/the:NRC will hold a public meeting during the public.commentiperiod'toidiscuss the rule. Tne meeting will be held'on February" 12 and -13,1991, lin Roskville, Maryland. The public meeting will provide:inierested persons an opportunity to q'ues-tion the NRC staff about the meaning intent',l logic, and Justification.of the proposed rule. The meeting will also allow the NRC staff to quest' ion commenters attending the meeting about why they may' object;to provisions of the proposed rule and how they would-suggest improving the rule. Another purpose of these exchanges is to allow commenters to improve their written ~ public comments because, through the' meeting,ithey might gain a better understanding of the meaning,< intent, an'd purpose of the proposed-rule.- To obtain further information and to register for the public meeting,. i write or telephone: Ms. Jayne-McCausland, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 492-1643. 24 5

-L' .. o VII. Summary of the Proposed Requirements and The Rationale-l for.Their Inclusion. l l 1 l The actual. wording of the proposed amendments appears in the text'of the proposed Part 36. The information presented'in this section.. summa-rizes the major requirements by wetion.of the regulation. The bases and originsofthemajorrequirementsarealsoexplained. i SUBPART A - GENERAL PROVISIONS. S 36.1 Purpose and scope. .This section describes the types of irradiators' covered in the proposed Part 36. The proposed: rule covers large: panoramic wet-source-storage, dry-source-storage, and underwater irradiators.f Large irradia-tors are those that can deliver a dose-of 500: rads (5 grays)'or greater: l-in one hour at a distance of 1 meter, either in air.or underwater as L appropriate for the irradiator type =- The dose rate criterion is taken i from the access control requirements 2 n the revised 10 CFR $ 20.3, Defini-a i u i tions, "Very High Radiation Area,"'under consideration by the Commission. 1 The 1-meter distanceLeffectively excludes self-contained irradiators. A cobalt-60 source of'approximately 400 curies (1.48 x 1018 becquerels) i would deliver this dose'.in air if the source were small;with little self-

absorption. A cesium-137 source would.need about 2,000 curies:(7.4 x-1018

-becquerels) to deliver the same dose.. For underwater irradiators, the source activities to deliver a 500-tad (5 gray) dose at 1 meter.would be about 10 times larger than if the exposures were performed in, air.- I ~25-s ., - +

l: 5 36.2 Definitions. This section defines terms'.that-are used:in the proposed new Part 36. t i SUBPART B - SPECIFIC LICENSING REQUIREMENTS' S 36.11 Application for a specific license. This section states how to apply.for a license and-where the-1 application must be sent.. ~ S 36.13 Specific licenses for large irradiatcrs. 1 This section describes information-that must be included in a license f application if.it'is.to be. approved by the Commission'.- The applicant's proposed' activities-must be.for a p'urpose authorized by the Atomic Energy Act of 1954.' This'isia standard requirement for all ' types of licenses. The applicant's proposed. equipment.andifacilities must be' adequate.to L protect the health of workers and the.public and minimize danger to' life. and property. The appl' rit must be qualified by training and experience. . to use the radioactive material for the purpose requested cand.in a manner that protects health and minimizes danger to' life and property; -These are standard requirements for all NRC licensees. The application must describ'e' the training' program fo'r-irradiator-operators.~ Criteria for acceptable. training programs are'not contained. L in the regulations so that flexibility can be allowed. :For example, the on-the-job training of-operators would be' different at a new irradiator compared to an existing irradiator. Guidelines for acceptable training [ programs are contained in the Irradiator Licensing Guide. 1 l l 26 '\\ ..2. m.

l l The application must contain an outline of the operating and emergency procedures. The NRC prefers-to review an' outline thatides-cribes the operating and emergency p'rocedures!in broad terms that speci-fically state the. radiation-protection ^ features'to be included in the pro-i cedures rather than the detailed operating.and emergency procedures. A step-by-step review of procedures'would generally not be'possible for a license reviewer'without intimate knowledge of the construction, layout, and operation of-the particular irradiator. Infaddition,_if' specific pro-cedures were reviewed, then minor changes that the facility might need to make from time to time (for example, due to replaced equipment or improv-ing-procedures' based.on what-is learned from-operating experience) could-require a time consuming and unnecessary. license amendment. This could-unnecessarily hamper the safety of facility' operation. ' Detailed proce-dures would be available to inspectors for reference during facility oper-ation, however, and documentation on changes ~ in procedures will' have to be retained-for inspection by~the NRC for three' years-($ 36.81(d)). The application must describe the responsibilitiesland. authorities i i of the radiation safety officer and other management personnel. The applicant must also describe the qualifications of the, radiation safety ~ officer. These are standard requirements ured to' judge whether the appli-cant's personnel are qualified to handle radioactive materials safely. Consideration was given as to whether the proposed. rule;should- . i l contain specific requirements for the qualifications of-the radiation-safety officer. Requirements could be placed on: the amount of formal radiation safety training, the amount of on-the-job training, the length and-type of previous experience,cand the amount-of formal education. It was decided not to specify minimum qualifications in the' rule because ' there is so much variability in qualifications among people who would be- -27 r l + ,rw+- ,e-.-, .---.s e-- u.-,--,

adequate to do the job. Instead, it was decided that guidanct.on qualifications should be included in a Regulatory-Guide and.that the NRC license reviewer should make the final determination of adequacy. based on' d the actual qualifications of a specific individual. This'would allow the license reviewer the flexibility to consider the strengths and weaknesses 1 of a specific individual 4 making the determination. Applications to operate panoramic irradiators must contain logic diagrams,of access control ~ systems. Applications also must contain information on how sealed' sources - would be: tested for. leakage and contamination.- The applicant must--submit information.on loading and unloading sources. I'f the applicant intends to load and unload sources,.the appli-- cant must.show that its personnel are qualified toido so safely and that its procedures.are adequate.to protect-health.and-safety. The applicant-may also have the loading and unloading done by another organization'that' the NRC or an Agreement State-has approved. " Approved"!means.that the qualifications of the organization that would;do the loading-and unloading have been reviewed by the NRC or an' Agreement State as part of a prior licensing action and the. organization has been found' qualified to safely' load and unload sources'. If the qualifications of)the organization have ~ not been previously reviewed, they.would then be reviewed as part of the current license application and, if found qualified, added to the list of + organizations approved to load and unload. sources. The applicant must also describe'the frequency of the operational inspection and maintenance checks required by 5 36.61.. Guidelines on the frequency of checks may be included >in. future NRC licensing guides. f l l L 28 i 1 .J.- s

1 U i 36.15 Start of construction. 1 This section prohibits the start of construction of any portion of the permanent facility on the site before a license'is issued. The sec-tion applies only to new facilities. An applicant is not prevented by this section from seeking a license to operate an irradiator that has been transferred from one owner to another or from converting an existing-facility, such as a hot cell, into an irradiator. I 36.19 Request for written statements. .This section codifies a requirement.(found in Section 182 of the 1 Atomic Energy Act) that the licensee must supply any. additional informa-tion required by NRC to assure that health and safety will be protected. SUBPART'C - DESIGN AND PERFORMANCE REQUIREMENTS FOR THE IRRADIATOR 1 i 36.21 Design and performance criteria for sealed sources. l This section lists the performance criteria /for sealed sources used. in irradiators. The performance criteria in the proposed ruleLate taken'from American. National Standard N542-1977. " Sealed Radioactive Sources.: Classification," - published by the Ngtjonal Bureau of'$tandards -in;1978 as NBS Handbook'126.: (Available from the American Nat.ional Standards Institute Inc., _1430

Broadway, New York, New York 10018.) The NRC has used this standard for.

many years and generally is satisfied.with the performance'of.the sealed sources that meet the standard. Nonetheless, there is a new requirement that -sealed sources installed after-the effective date of the' rule be doubly L encapsulated. Double encapsulation provides additional protection in case 29^ l + w ________z,__________

7 1 one of:the' welds in the source is defective. The likelihood of two c defective' welds in one source is less than the likelihood of one: weld being defective. Most of the approved sources currently in use are aoubly encapsulated. -The proposed rule does not specify any requirements forLsealed sources installed prior to the effective date of the rule. Current'NRC 1 i staff practice.is to-approve sealed sources on a case-by-case basis, using. the criteria iri American National, Standard N542-1977. Thus, all sources installed prior to that date would have been ' approved by-the staff on a case-by-case basis,.using_ effectively the same cr.iteria as in ine. proposed rule, with the exception of the requirement:for double encapsulation. 1 f t S 36.23 Access ::atrol. This section states-requirements for. systems intended-to-prevent ~ entry into the radiation room-of_a panoramic irradiator while:the source r is exposed. i 4 The proposed requirements were taken largely from the existing 10 CFR 20.203(c)(6) and (c)(7), but-an-attemptihas' been made tol simplify 'the word-ing of these requirements. In addition, a. requirementthat the entrance L L to the radiation room must have a " door.or other physical barrie'r to pre-I vent inadvertent entry" has been added. Although the present regulation. in 10 CFR 20.203(c)(6) does. not-rhuireia door or barrier, the.NRC;11cens-ing staff has'usually required that a door or barrier be.provided. The-proposed rule explicitly states the requirement. 'As a part of the final rulemaking on the new Part 36, existing 10 CFR.20.203(c)(6).and (c)(7), which apply only to large irradiators, will be delete.: from Part 20 to coincide with the effective date of the Part 36 requirements. 1 -30 s l ,,-n;

s i o, For panoramic irradiators, the proposed section would require a primary access control system and an independent backup access-control system. In addition, operational-requirements for_ preventing a person from being in the radiation room while the sourceLis exposed are contained in S 36.67, " Entry into and exit from the radiation room." The door or barrier that serves as the primary access control system must have controls that would (1) prevent the source from being moved out of its shielded position if the doorLor barrier were open and (2) cause the source to return,to.its shielded position if;the door or barrier were opened while the source was exposed. The backup access control system-must be-able to-detect entry while the source'is exposed. If entry is detected, the system-must (1) auto-- 1 matically cause the source to return to.its shielded' position and (2) ectivate audible ana visible alarms. In addition, the proposed-rule ~would require > a radiation monitor in the radiation roor .anoramic irradiators.to detect radiation when the source is indicated to be in the fully shielded position. The. radiation monitor would have alarms andian. interlock lon the personnel access door. This is a new requirement not in the existing 6 20.203(c)(6) -The purpose is to provide an additional level of protection in case of some failure of 3 the source movement mechanism combined with a fail're of the operator to u 4 make the required radiation surveh upon' entry into the-radiation room.' The phrase currently used in $ 20.203(c)(6)-concerning reduction of-radiation levels upon entry is worded so that-an individual could not receive "a dose in excess: of.100 mres in one-hour." This requirement has been changed in 6 36.23 to state that the time for the sources to return to the shielded position must be less than or equal to the time that it 31

would take a person entering the radiation room to walk to the edge' of the-pool (wet-source _-storage).or into the beam (dry-source-storage). This I wording more directly states-the intent of the requiremen'. If ~necessary,. t -the licensee could use a time-delay mechanism to delay opening _the' door af ter unlocking.it. The access control requirements applycto'each entrance of the-radiation room of a panoramic irradiator whether intended for personnel access or intended only for product entrance or exit.- Panoramiciirradia- ~ tors with a conveyor system could meet the req'uirkent by'providing clear # c l ances around-the conveyor carriers that'are too small to allow someone to-pass through.. The requirement is that the door or barrier must prever,t- ~ 1 inadvertent entry. The purpose of this requirement is'to prevent ~a reason c ably prudent person from carelessly, inattentively,'or accidentally-enter-ing the radiation _rcom while the: source is' exposed.; ~ The access control section;would require an independent. backup access L control system.on panoramic-irradiators. ' The backup system could use L L photo-electric cells in antentrance maze, pressure sats on theLfloor,,or similar means of detecting a person entering the radiation room while?the source is erposed. The purpose of.the backup. system is toiprovide a redun-q dant means'of preventing a person from being accidentally; exposed to the source. In' case of a failure of the interlocks on-th'e. door or barrier combined with a failure to follow operational proceduret,'the: backup.sys- [ tem should warn the person entering?the; radiation room of the dangerLand -automatically cause the sources to return,to'their shielded position. The system must also alert another person'of'the entry. That person must be . prepared to render or summon assistance. This provision-prevents the l l operation of the panoramic.irradiator without a second person.beingiavail-able to render or summon assistance. 32 o

o i The section explicitly w that the irradiator may not operate if { the requirements of the section are not met. This section also contains requirements for underwater irradiators. For example, the pool must be within an area surrounded by a personnel access barrier with an intrusion alarm when the-facility is not operating. 6 36.25 Shielding. I This section specifies maxim..m dose rates outside the radiation' room of a panoramic irradiator and maximum dose rates over pools. The' maximum. [ dose rate of 2 millirems (0.00002 sievert) per hour is considered both practical to achieve and low enough to permit continuous occupancy by workers anywhere outside the shielding. The value was previously speci-fied in the Irradiator Licensing Guide. Two millirems (0.00002 sievert) in an hour is the maximum radiation dose allowed by 10 CFR Part 20 in an unrestricted area for one-hour time periods. For measurements to determine compliance with the requirement, the rule specifies 30 cm as the distance from the shield to the detector. l This distance is selected because at that distance the dose WJld be a l whole-body-dose and not a dose occurring in a small crevice or opening. The maximum area of 100 square centimeters for averaging dose effectively establishes a maximum detector size. l The section does not require hat the NRC approve the shield design. Instead the regulations contain only a ' performance requirement on anximum dose rate outside the shield. The requirements apply to the completed shield. 1 'It is possible~ that, in its first test, some part of< the-shield might fail to meet the. performance requirement. If this occurs, the effect of 33 _.m

9 i i the regulation is to require that the shielding deficiency must be corrected before operation of the facility can begin. l The section also. specifies maximum radiation dose levels outside the shielding of dry-source-storage irradiators. The levels are considered-practical and adequate to maintain doses to_ workers as low as is reasonably achievable. The levels were specified in the ANSI Category II Standard. i $ 36.27 Fire protection.. The heat generated by irradiation can cause combustible materials to catch fire. The requirements in this section are intended to_ prevent-fires, dett,.. fires if they occur, and allow fires to be extinguished wiihout entry of personnel into the radiation room, e The requirements for fire detection and sprinklers or other systems ~ to extinguish a. fire at a pannramic irradiator were taken from the ANSI Category IV Standard. -The fire extinguishing system does not have.to be automatically activated, i Overall, fires are considered to present relatively.'little hazard to irradiators Radiation rooms.use little combustible material in their construction, and irradiation of highly flammable and explosive materials is' prohibited (by426.69)withoutNRCspecificapproval. The products being irradiated are likely. to be combustible, but there is not likely to be present a sufficient quantity 'o'f combustible material _ to result in pro-longed high-temperature fires.. Thus,- the temperature reached is not likely to be high ensgh to melt or rupture the stainless steel capsules contain-1 ing the radioactivi sources. Therefore, the NRC would not expect a fire to cause loss of encapsulation even if the fire were not centro 11ed and the sources were not dropped into a. source-storage pool. 34 I' - -. -. ~.. = - -,.. -.

l The fire extinguishing s) stem is required because a fire could disable the access control system or could prevent the source from being shielded, thereby lowering the margin of. safety. The fire extinguishing system must be operable without entry into the room. During a fire there i would be no means of assuring that the access control systems and source position indicators are operating properly. Also, no one could be sure that tha >'ahanism that returns the source to the shielded position had operated properly. $ 36.29 Radiation monitors. This section requires a radiation monitor to detect radioactive sources on the exiting product. The requirement was taken from 10 CFR 20.203(c)(6)(viii) and from the ANSI Category IV Standard. The. purpose of this requirement is to detect sources that have somehow become loose i from the source rack and are being carried out with the product and to i stop them from being carried out of the radiation room, j This section also requires radiation measurements to detect leaking sources at pool irradiators and a monitor over the pool at. underwater irradiators. $ 36.31 Control of source moveme.nt. S This section contains the requirements for the control of source movement at a panoramic irradiator. Generally,.the requirements are taken from the ANSI Category IV Standard. $ 36.33 Irradiator pools. This section contains requirements for irradiator pools-35 n. y ,w w -- - w

For facilities licensed for the first time after the effective d2te of the final rule, the proposed rule would require either: (1) a stain-less steel pool liner (or a liner metallurgically compatible with other components in the pool), or (2) construction so there is a low likelihood of substantial leakage, a surface designed to facilitate decontamination, and a means to safely store sources during repairs of pool walls. Back-fitting is not required because modifying an existing pool would be pro-hibitively expensive and the gain in safety would be only marginal. Older facilities sometimes used concrete pools, sometimes lined with tiles, but usually without stainless steel liners or other ways to reduce the likeli-hood of leakage. The ANSI Category IV Standard does not require pool liners. However, unlined pools have leaked from time to time. The pur-pose of the requirement is to reduce the likelihood of pool leakage. It is desirable to control pool leakage in case the pool water becomes con-taminated due to a leaking source..If the pool were leaking ord a source i leaked at the same time, a potential for worker and public exposure would exist, and it could be difficult and expensive to decontaminate the facility. The NRC considered whether to require that pools have a more sensitive means of ottecting water leakage from pools than tonitoring water loss. ' Examples of more sensitive means might be a-double lined pool or channels at welds with a means to detect' water leaking from the pool. The NRC decided that it would be adequate to monitor pool water loss and unneces-f sary to have a more sensitive means of detecting leaks. There are tco reasons for wanting to avoid leaks.- One reason is that a substantial lowering of the pool water level would cause radiation levels at the pool surfcce to increase. The i# creased radiation levels are not a safety 36 I

Y I concern unless large volumes of water are lost. A system to monitor water j loss could easily detect leaks before a safety hazard would result. The r l second reason to avoid leaks is to prevent the escape of radioactive mate-rial that might be in the pool water. In normal circumstances a pool leak is not a safety concern because pool water contains little or no radio-active material. If a source leak occurred while tt.e pool had a small undetected leak, some contaminated water could escape from the pool. Experience has shown that pool contamination levels-do not get very high so that the escape of a small amount of pool water into the ground is not a significant safety concern. Therefore the NRC does not consider that a pool leak system more sensitive than that required in the proposed rule is necessary. The proposed rule would require both a means to replenish water that is lost and a low-water level indicator. The means'to replenish the water dLes not have to be automatic. An indicator is needed even if the replen-ishment is automatic in case the system to replenish the water does not work. The requirement for a cover or railing to prevent workers from falling into the pool is taken from the ANSI Category IV Standard. L The proposed rule requires a water purification system. The purposes of the purification system are to prevent the pool water from becoming cloudy and reducing visibility-and from becoming corrosive and thus cor-roding the stainless steel sealed sources or the source rack. If the water is clear, it should be possible to visually inspect the sources and the. source rack. Thus, the sources and the source rect could be inspected-for damage, and the location of the sources could be checked to make. sure they are in their proper positions. Requirements on the design of poles and long-handled tools'to be use. J in irradiator pools would be imposed to prevent radiation " streaming." 37 l-4

t 'l Hollow and low density poles and' tools must have either vent holes to allow shielding water to enter or sufficient bends to prevent radiation levels.at handling areas of the tools from exceeding 2 millirems (0.00002 i sievert) per hour. 5 36.35 Source. rack protection. This section would require a barrier.to prevent the moving products' l from hitting the source rack or the mechanism that raises and lowers the sources. 6 36.37 Power failures. s This section would require automakic source retraction for loss of power for more than 10 seconds at a panoramic irradiator. The retraction would have to be acenmplished without outside power. Backup power is not required as long as loss of power will'cause the source to return to its shielded position, for example, if the source would return to'the shielded position due to gravity. The requirement is taken from the ANSI Category IV Standard. S 36.39 Design requirements. This.section describes facility design requirements. The r.rpose of 1 l the requirements is to make sure the design is adequate before construc-1 tion starts, l Included in the section is a requirement that all'irradiators must l have shielding walls constructed of reinforced' concrete designed to meet generally accepted building code requirements for reinforced concrete, ,This provides protection against moderate' earthquakes, tornadoes, and other hazards. R i

_.. _ _ ~ _. _ --.__. [ 5 In addition, irradiators built in seismic areas must have, radiation shields designed to retain their integrity in an earthquake. Seismic areas are defined in 6 36.2 as any area where the probability of a hori-zontal acceleration in rock exceeding 0.3 times the acceleration of gravity in 250 years is greater than'10 percent. The value of 0.3 comes from the ANSI Category IV Standard. The 250 year frequency is different from the frequency in the standard, which specifies a 50 year frequency. The NRC selected 250 years to include some areas that could have a large earthquake j even if large earthquakes would seldom occur. Maps of the United States showing these seismic areas are published by the U.S. Geological Survey (see S. T. Algermissen, et'a1., "Probabilis-tic Estimates of Maximum Acceleration and Velocity in Rock in the Contig-uous United States," United States Department of the Interior, Geological Survey, Open-File Report 82-1033, 1982. This report may be purchased for $24.50 from: U.S. Geological Survey, Books and Report Sales, Box 25425, Denver, Colorado 80224. Prepayment'is required). Studies of irradiator shield designs have.shown that the shields are inherently able to withstand large earthquakes. ANSI determined that 1 l reinforced concrete shields-constructed to meet generally accepted build-L ing code requirements for reinforced concrete (for example ACI Standard 318-77, " Building Code Requiremerv se Reinforced Concrete," available for purchase from the American Concreta Institute, Box 19150, Redford Sta-E tien, Detroit, Michigan 48219) can withstand an earthquake with an accel-1 eration in rock of 0.3 times the acceleration of gravity plus any multi-plication of acceleration that would occur'due.to' soil.- Therefore, there are no seismic requirements for irradiators located where accelerations in rock are not likely to exceed 0.3 times the' acceleration of gravity. 39 z 4 -en-.+- r-, r-,,,,r ,-sw en-v

I o l l The proposed rule would intend that shield walls in seismic areas would have to retain their integrity in the event of an earthquake by requiring that they be designed to meet the seismic requirements of local i building codes or other appropriate sources. Local building codes in f seismic areas are likely to specify requirements for things such as: spacing of reinforcing bars; how to tie reinforcing bars together; pre-ferredarrangementsfor.reinforcingbars;andrequirementsforjoining' reinforcing bars to floor slabs. If local building codes do not contain i seismic requirements, "other appropriate sources" could include: American Concrete Institute Standard ACI 318, " Building Code Requirements for Rein-forced Concrete, Appendix A, Special Provisions for Seismic Decign," (available for purchase from the American Concrete Institute, Box 19150, RedfordStation, Detroit, Michigan 48219).. The NRC solicits comments, in particular, on this requireheent. The NRC also. considered whether there should be design requirements for shkid integrity against tornadoes. The NRC decided that there was no need for special design requirements because the shielding by'its very nature-(about six feet thick reinforced-concrete)'is inherently resistant to tornadoes. $ 36.41 Construction control. This section describes checks that the licensee must make before I sources are loaded to be sure the facility was constructed as designed and that alarms, controls, interlocks,'and instruments operate properly. l 1 40

4 l SUBPART D - OPERATION OF THE IRRADIATOR $ 36.51 Training. l This section contains safety training requirements for irradiator operators. The emphasis is on practical knowledge directly necessary Tor the job rather than theoretical principles. i Thesubjectsthatanirradiatoroperatormustbetrainedinare: (1) The fundamentals of radiation protection as they apply to r irradiators. The goal here is to provide the individual with the neces-l sary foundation to perform his or her task safely and to help the indivi-dual worker understand the basis for.the safety requirements and procedures that will be taught. (2) The requirements of Parts 19 and 36 of NRC regulations. The operator is not expected to be-an expert on NRC regulations or to be able i to determine whether a given procedure is-adequate to meet NRC regula-l tions. Instead, o W ators should be instructed on NRC requirements that are directly applicable to their responsibilities. (3) The operation of the irradiator. Theobjectiveisnottomake the individual an engineer, but to help the person understand the oper-ating and emergency procedures. (4) Licensee operating and emergency procedures that the individual will perform. This is the most important part of the training because the. safe operation of the-irradiator depends on the procedures being followed correctly. Theobjectiveisthattheoperatorbeabletocorrectlyper-form the procedures that he will be expected to perform. The training does not have to include procedures that the individual!will not perform. For example, if the individual will-not perform leak tests, the individual 1 need not be trained in the procedure. 41

l (5) Case histories of accidents and problems involving irradiators similar to thofe to be used by the individual. The individual should be taught about situations that could lead to trouble. Instruction material on acciGnts is often difficult to obtain. However, the previously men-i tioned NRC Report NUREG-1345, " Review of Events at Large Pool-Type Irra-diators," should provide some relevant information. l In order to provide flexibility,.the proposed rule intentionally does not specify how many hours of classroom training and on-the-job training are necessary to become an irradiator operator. -A license applicant would describe the training program in its license application. The Irradiator Licensing Guide suggests 40 hours of classroom training and one month of-on-the-job training. The proposed rule also does not specify the training or qualifications needed by the radiation safety officer. This is also to allow flexibility. The license applicant would describe the minimum training, experience and qualifications of the radiation safety officer in its license application. A review would then be conducted on a case-by-case basis. The Irradiator Licensing Guide suggests guidelines for basic radiation protection train-ingandon-the-jobtrainingfortheradiationsafetyofficer. The NRC considered whether the proposed regulation should include' training requirements for other types of workers such as-package handlers and maintenance workers. The NRC concluded that the general training requirements specified in $ 19.12, " Instructions'to workers," are suitable for other types of workers, and therefore additional or more specific requirements are not necessary., 42 ,um,~ m ,.-,._.,__..,m. ..... m m

1 1 6 36.53 Operating and emergency procedures. This section lists the specific operating and emergency procedures that a licensee must have. The section also lists requirements for chang-ing these procedures. Operators must be instructed in a changed procedure before it may be put into use. Changes in procedures that do not reduce the safety of the facility and are consistent with the outline submitted l in the license application do not have to be approved by NRC nor must changed procedures of this type be reported to NRC. However, documenta-tion on the changes must be retained for inspection by NRC ($ 36.81(d)). S 36.55 Personnel monitoring. This section contains the personnel monitoring requirements for irradiator operators and other people entering the radiation room of a panoramic irradiator. It could be argued that this section is not needed because the requirements in i 20.202, " Personnel monitoring," are adequate for irra.11-ators. Section 20.202 requires besonnel dosimeters for anyone likely to receive in excess of 25 percent of an-applicable dose limit. At irradia-tors, as currently designed and operated, no operator is likely to exceed 25 percent of a dose limit. -Therefore, f 20.202 does not require any use of dosimeters at irradiators. Nevertheless, the NRC wants operators to l use dosimeters so that there is a dose measurement in case someone enters l l the radiation room while the source is exposed, even though entry is not likely. Therefore, the NRC' considers it desirable to impose dosimeter. l requirements in excess of those in 6 20.202. l Film badges and'thermoluminescent dosimeters-(TL0s) must be suitable for detecting high energy photons'in the normal and. accident dose ranges. l Paragraph (c) of 6 20.202, " Personnel monitoring," reluires that film 43 ..- W ..,4 .....c. ..k-.. ~~ - o.,

badges and TLDs must be processed by'an accredited processor for the types of radiation that would be encountered. For irradiators, the radiation type is high energy photons-in both the normal and= accident dose ranges. i In the "American National Standard for Desimetry-Personnel Dosimetry Per-formance - Criteria for Testing," ANSI N13.11-1983, the normal dose range 1 is 0.03 to 10 rems (0.0003 to 0.1 sievert) and the accident dose range is 10 to 500 rads (0.1 to 5 grays). Pocket dosimeters, which could be worn by people other than operators, need not be calibrated because their purpose is primarily to indicate either no dose or a very large (but not quantitatively measured) dose. $ 36.57 Radiation surveys. This section lists the radiatioe surveys that must be done and specifies how often they must be done. An annual survey instrument calibration is in accordance with the recommendations of American National Standard N323-1978, " Radiation Pro-tection Instrumentation Test and Calibration." Modern survey meters are considered reliable and stable, making more frequent calibrations g unnecessary. i l-The accuracy requirement for survey meter calibration is t20 percent. In the-past, the NRC has specified accuracy requirements of t10 percent for some uses and *20 percent for other uses.' Modern survey _ meters can fairly easily be calibrated to be accurate to 120 percent on all scales over their entire range of. dose rates. On the other hand, calibrations to t10 percent are often difficult-to obtain and sometimes require the~use of calibration charts for. correcting the meter reading. The charts'make 1 the survey meter more complicated to use and increase the likelihood of 44 ._1.- .w.. .m.,. ...~, l.- .-. -. - ~ e,.-.. ~. -

a l errors in reading the meter. In determining the accuracy requirement for survey meter calibration, the key question, therefore, is when is an accuracy of 210. percent needed, and when'is an accuracy of *20 percent adequate to accomplish the purposes of the measurement? The discussion below answers this question. i At an irradiator, the most important and frequent use of the radiation survey meter is to confirm that the source is shielded when entry into the radiation room is made. The survey meter is used to deter-mine whether dose rates in the entrance maze are the normally-occurring very low dose rates or are many times higher than normal. For this'pur-pose, a survey meter accurate to t20 percent is acceptable. Another use of the survey meter.is to verify that the dose rates outside the shielding wall and at the restricted area boundary are in com-pliance with NRC limits. These measurements are done infrequently. The + most~important purpose.of these measurements is to check that the shield-ing contains no voids or poorly designed penetrations. Another purpose is to verify that limits on dose rates are not exceeded. A-quantitative mea-surement is nedded rather than a qualitative yes/no indication to v'erify l that dose rate limits are not exceeded. However, at most facilities it i has been found that the actual dose rates outside shield walls and at restricted-area boundaries are'far.below the regulatory' limits. There-fore, a highly accurate quantitative measurement is not normally needed. Accuracy of 120 percent is normally adequate to verify compliance. It is possible that a measured dose rate might be very close to a-limit.. In those special situations, the licensee might need a measurement-more accurate than *20 percent. Thus, the accuracy requirement of't20 per-cent in the regulations, does not mean that the licensee would never need 'a l l 45

= measurement more accurate than t20 percent. Rather, the regulation means that the ordinary routine periodic calibration need only be within 120 percent. Most facilities would never need a more accurate calibration, but others at'some time might. I In summary, the NRC position on survey meter calibration is that accuracy of t20 percent is adequate for most routine measurements around irradiators and, therefore, adequate for routine gamma survey meter cali-bration. On the other hand, certain special measurements may require more accuracy to demonstrai..-compliance with regulatory limits. Thus,.'in spe-cial instances at specific parts of the dose rate range and for specific j gamma ray energies, more accuracy may be required. Those calibrations ) would be done specifically for the measurement to be m3de (dose rate range,gammaenergy,andgeometry). Very high range survey meters (those that could measure dose rates in the radiation room while the source is exposed).are not required because the NRC could not see a need for this type of measurement. Normal range survey meters are adequate'to determine whether sources are fully shielded. Radiation rooms should not be entered if the sources are known to be I exposed. Section 36.57 also requires that deionizing resins be monitored for radioactivity before release to unrestricted areas.; The NRC considered r l prohibiting the return of deioniz'ing resins to suppliers for recycling, Irradiator sources could have small-amounts of radioactive contamination on their surfaces due to manufacturing processes. Some of this contamina-t tion could be collected in the resins. Thus, even resins.that.have no detectable radioactivity could contain small amounts of radioactivity.- If mixed with other resins, the dilution would ba tr.at much larger. Thus,. 7 l .l l 46 l l d' .. J

) i l i 1 l concentrations in the waste stream from regeneration, if any, would be'far below the 10 CFR Part 20, Appendix B, effluent limits. An approach to monitoring very low quantities using survey instruments has been used for medical waste (see Regulatory Guide 10.8, " Guide for the Preparation of Applications-for Medical Use Programs," Appendix R.) Cal-culations of dose rates show that concentrations of radioactivity.in~ resins l' would have to be below a small fraction of the effluent limits for water l l in.10 CFR Part 20, Appendix B. 'If the resins were regenerated, the amount l-of backwash solution that would remove the radioactive material from the resins would dilute the concentration of the material.by at least a factor ~ of 20, based on the volumes of water used in regeneration. Thus, the pro-posed requirement, instead of prohibiting ti,e return of resins, is that resins must be monitored before release in an area with a background radi-i ationlevellessthan0.05 millirem (0.0005 mil 11 sievert)perhour.- Radi-i ation levels must not be detectable above background radiation levels. The survey meter must be capable of detecting radiation levels of 0.05 millirem (0.0005 mil 11 sievert) per hour. Most G.M. survey meters would be adequate. The Commission considers this approach adequate to protect public health and safety. 6 36.59 Detection of leaking or contaminated sources. This section describes how and when leak testing.of sealed sources must be done. There are different requirements for dry-source-storage and wet-source-storage sources. U.S. Department of Transportation regulations. require that all sources, dry-storage and wet-storage, be ' individually leak' tested in order-to be shipped. Leak tests are normally done'by the manufacturer. ~The 47 ,~.- --

= \\ l licensee must obtain a certification from the manufacturer indicating that the leak testing has been done. The requirements for dry-source-storage sources are similar to those contained in the.second proposed Revision 1 to Regulatory Guide 10.9, j " Guide for the Preparation of Applications for Licenses for the Use of. Self-Contained Dry Source - Storage Irradiators." A level of 0.005 microcurie (185 becquerels) on a dry wipe is the level of contamination considered to indicate a leaking or contaminated source. Traditionally the level for irradiator sources has been 0.05' microcurie (1850 becquerels), and that value is used in the Irradiator-Licensing Guide and the ANSI Category IV Standard. The reason for the change is that previous manufacturing processes caused considerable sur-face contamination and irradiator sources could not be cleaned to below 0.05 microcurie (1850 becquerels). Also, detection of quantities below l 0.05 microcurie (1850 becquerels) was difficult. However, source manu-facturing techniques have improved so that sources are now cleaner and have less surface contamination,.and. instruments:have. improved so it is possible to detect 0.005 microcurie (185 becquerels) of activity. -Thus, the NRC believes it is now practical to meet a contamination level of I 0.005 microcurie (185 becquerels). The 0.005-microcurie (185 becquerel) quantity serves to alert the licensee that there might be a problem.- Detection of 0.005 microcurie (185 becquerels) shows e need for further evaluation. : The quantity is not justif'ed on specific assumptions of risk. It is a sufficiently small quantity that it presents very low levels of risk, but.it is measurable. It is not used in the regulatory program or by industry as a limit on allowable leakage rate. If any leakage is discovered, the source should \\ 48 F ..e-.- n-,. ee m ..wm.

i be removed from service. Further, although termed a " leak test," the usual test performed by users of sealed sources is a "contaminatien test." A positive indication does not necessarily indicate leakage. It could indicate surface contamination deposited during the manufacturing process. Leak testing of sources used in pools cannot be done by wipe-testing l the sources. The proposed rule would require that radioactive contamina-i tion be monitored each day the irradiator operates either by on-line moni-toring of a pool water circulating system or by analysis of pool water. If on-line monitoring is used, detection of above normal radiation would have to automatically cause the water purification system to shut'off. The purpose of the shut off is to prevent high radiation dose rates in .the water purification system. The NRC also considered whether water purification systems should be shielded. The NRC believes that high dose rates might be a possibility if flow were not shut off, but does not believe that the normal water purification systems are always appropriate for cleaning up a leak if the leak were large. For a large leak, special equipment might be more suit-able. Therefore, the rule requires.a shut off of the system if a high p radiation level is detected rather than requiring-shielding. If eme'r-gency procedures allow the normal water purification system to be used, temporary shielding appropriate for the_ specific situation could be used as specified in the emergency procedures. Section 36.61(a)(3) requires a check of the operability of the radiation monitor on the pool water purification system with a radiation check source. The monitor.is used to detect radiation levels that are-above normal ratber_than to make. quantitative measurements of doses. For this purpose simple operability checksfare appropriate. 49

l 5 36.61 Operational inspection and maintenance. j Operational inspection and maintenance includes the items that the licensee must periodically check to assure _ proper _. operation of the facil-ity. The frequency of checks is not stated in the regulations because the frequency will be site-specific depending on the design of the facility. The frequency of checks must be described in the' license application, as requiredini36.13(h). ] The NRC considered whether the frequency of checks on the access l control system, probably the most important safety feature of an'irradia-tor, should be specified'in the regulations. The NRC concluded that there is too much variation in irradiator design and operation to specify a fre-quency that would apply in all cases. Therefore the NRC decided that the applicant should propose a frequency _in the license application. This approach allows flexibility and at the same time allows the NRC to approve a frequency of checks that it considers adequate-for a specific facility. i . Guidance on criteria for. generally applicable frequencies for checks will i be offered in a regulatory guide. $ 36.63 Pool water purity. This section would require that the water purification systems in irradiator pools be run.each cay the ir. radiator operates'or at least monthly during shutdowns. Purification systems do not_have to be_run con-- tinuously and do not have to be.run'the entire time the irradiator.oper-ates, although many licensees may have to run the system continuously to maintain pool water conductivity near 10 microsiemens (micrombos) conduc-j tivity. If water conductivity' exceeds 10 microsiemens (micrombos) per centimeter, the system must be run until the water conductivity is below 50 ~. -

i 10 microsiemens (micrombos). The purpose of maintaining clean water is to reduce corrosion of the sources.and to keep the water clear. Clear water is desirable so that the sources and source rack can be inspected visually to check their condition. The NRC considers conductivity to be the best method of checking the purity of ths water in irradiator pools. ) ~ With regard to corrosion, the operating environment is as follows: The sealed sources used in irradiators are most commonly clad in 316L stainless steel. Sometimes 321 stainless steel is used. While in the pool, the temperatures of the sources are generally 80 to 90*F. In air the temperature of the sources can run as high as 300 to 400'F. The sources used with conveyor systems are typically cycled in and out of the-l water several times a day but sometimes more ofte'n. Batch irradiation sources may be cycled several dozen times a day. Under these tircumstances, generalized surfact corrosion should be minimal and not 44 u ncern. The type of corrosion of potential concern might be chlori &inder.ed stress corrosion cracking. Although inspection of sources that have been used in irradiators for long periods have revealed' virtually no chloride-induced' stress corrosion cracking, it-is i L desirable as a precaution to operate the sources in a relatively low cor-rosion environment. Maintaining water conductivity over the long term in the vicinity of 10 microsiemens (micrombos) p6r centimeter should provide j a low corrosion environment, although considerably higher levels could be tolerated for fairly long times with no threat-to safety. Comments on this approach to water purity are specifically requested, p $ 36.65 Attendance during operation. This section describes how an irradiator must be attended during-operation. 51 D p 6%v 2 e e- + w s-- m v + m. ^we. w -r a

t j $ 36.67 Entering and leaving the radiation room. This section describes the requirements for first entering the radiation room of a panoramic irradiator after an. irradiation and for 1eaving the radiation room and locking it'up before an irradiation. It also covers entry to the pool area of an underwater irradiator during a i power failure. $ 36.69 Irradiation of explosive or highly flammable materials. l The proposed rule would prohibit the irradiation of explosive materials or more than traces of highly flammable materials unless the licensee has prior written authorization frcm the NRC. The. reason for. these prohibitions is that irradiation can cause chemical reactions that would cause a fire or explosion of highly flammable.or explosive material Highly flammable materials are those with a flash point temperature below 140'F. The flash point of 140*F was taken from the ANSI Category IV Standard. The flash point is the lowest temperatura at which a substance will volatilize to yield sufficient. vapor to form a-flammable gaseous mix-ture with air, demonstrable through the produccion.of a flash on contact with a small open flame. The flash points ef common substances are tabu-L lated in various engineering handbooks and manuals, for example, " Accident Prevention Manual for Industrial Operations," National Safety Council, Chicago,1974, and " Handbook.of. Laboratory Safety," Second edition, Chemi-cal Rubber Company, 1971.. Examples.of common flammable materials with a flash point below 140'F aret acetone, benzene, most alcohols, number two fuel oil, gasoline, kerosene, toluene, turpentine,.and any flammable gas. i 52- 'e i -. n.*:e- %~.. +-er m,-w- - = s---..m w s a -,--v-+--- e+ w

. ~ _ _. - SUBPART E - RECORDS AND REPORTS $ 36.81 Records and retention' periods. 1" The records that a licensee must maintain and their retention periods-are specified in a single section, f 36.81, for ease in implementation. Thus, the licensee has a convenient " check list" to use to make sure that al' records required by Part 36 are kept. l The purposelof requiring the licensee to maintain an inventory of all sources posser ed is to assure that the licensee is able to account for all sourcer in its possession. The attivity of the sources is the activ-ity whe:i they were received. There is no safety need to correct for radio-active decay. Decay corrections would greatly complicate record' keeping withoutcontributingtothe'objectiveoftherequirement,whichisthat the licensee be able to account for each of the sources that it received. $ 36.83 Reports. This section lists all reports that are required by Part 36. All 1 I reports required by Part 36 art included in a single section for ease of use by licensees. Paragraph (a) requires reports on-lost or stolen sources, radiation overexposures, excessive levels or concentratiuis of radiation, and damage l to or loss of the ability to operate the facility due to events ' involving radioactive material. The paragraph references the event reporting requirements of Part 20. The NRC is currently considering changes in the i Part 20 reporting requirements. 'If Part 20. isJamended, corresponding changes would be made in the Part 'S reporting requirements.- 53- .. ~..

l Paragraph (b) requires reports to individuals on radiation exposure as requ red by Part 19. This paragraph likewise places no new or different l reporting requirements on licensees. l Paragraph (c) requires reports on leaking sources. The requirement is similar to the requirement now generally imposed under a license condi-tion. The reporting period would be 5 days from the time of discovering ~ l the leak to allow-.for completeness in the reports, especially with regard to corrective. actions. Paragraph (d) requires reports within 5 days of other events with possiblesafety.significanceifnotreportedunderparagraphs(a),(b), or (c) even though they may' involve no violations of the regulations or license conditions. The purpose of the reports is to make NRC aware of-problems that should be reported to other licensees because of their safety significance. The 5-day reporting period in paragraphs (c) and (d) represents a l balance between allowing sufficient time to' collect, analyte, and writeup the necessary information and requiring that the report be submitted before recall of events fades. Reports submitted generally would be subject to public disclosure in accordance with 10 CFR 2.790 and 10 CFR Part 9. The NRC was asked at a 1988 public meeting on irradiator safety.whether proprietary information could be withheld from public disc'losure.. The NRC notes that 10 CFR 2.790 allows the NRC to withhold certain proprietary information (information of 1 commercial value or " trade secrets") if, at the. time' of submittal of the report, the requirements for withholding the information are met.(refer to-10 CFR 2.790(b)). Also, there are provisicns in'10 CFR Part 9 for. the NRC L to. withhold' from public disclosure documents such as reports of radiation exposure to individuals and other personal records. 54 i ~. s ...,L, J. .-n s

i SUBPART F - ENFORCEMENT l 6 36.91 Violations. This section is provided to inform licensees and the public that violations of the regulations may result in civil or criminal penalties. VIII. Other Considerations t I Certain other issues that were considered, including some that did not result in a requirement in the proposed rule, are discussed here. A. Siting, zoning, land use, and building code requirements. The NRC recognizes that most-areas have zoning, land use, and building code requirements that would be applicable to irradiators. It is the responsibility of the applicant or licensee to assure that any pro-posed facility meets the zoning, land use, and Hiding code requirements of the local and State governments having jurisdiction'over the intended site. The NRC is not responsible for checking or assuring that State and local requirements have been met. The granting of an N'RC license does not negate applicable local zoning, land use or building requirements. As a practical matter, this means that in order to meet State and j local requirements, irradiators must be built in areas zoned for indus-trial facilities and not in residential areas.. The applicant is advised l-to consult with the State and local governments before starting construc-l 1 tion to assure that the facility would meet all State'and local siting, zoning, and land use requirements.- The NRC believes that an irradiator. meeting the requirements in the new Part 36 would present no greater i 55 w ,e e n sene,- ,m p p p

I j i l hazard or nuisance to its neighbors than other industrial facilities, l 1 because there is little likelihood of such an irradiator causing radia-j l tion exposures offsite in excess of NRC's Part 20 limip for unrestricted I areas. Therefore, the NRC believes that, in general, irradiators can be u located anywhere that local governments would permit an industrial facility l to be built. The NRC considered whether there should be siting requirements + dealing'with possible flooding of the irradiator or. tidal waves. The NRC decided that no siting requirements with respect to possible flood-ing or tidal waves were necessary because flooding of.the facility would not destroy the integrity of the shielding walls. Section 36.39 contains a requirement that shielding walls of panoramic irradiators must be constructed of reinforced concrete designed to meet generally accepted j building code requirements for reinforced concrete. With this type of construction, shielding and sources are.well protected from being carried off in a flood or wave or damaged due to a flood or. wave.. Flooding of the facility would undoubtedly result in the need for a' time-consuming and expensive repair of flood damage, but no particular radiation hazard would be involved during repair of flood damage because sources could be safely stored during the' repairs..However, the proposed. rule does include l t a requirement to have emergency procedures for coping with natural phenomena such as floods. The NRC also considered 'whether seismic zones should be' considered in l siting requirements. The NRC' decided that irradiators could be built in any area of the country, but that irradiators in seismic areas (as defined in 6.36.2) would need shielding walls designed to withstand an earthquake. If an irradiator were subject to a large: earthquake, the potential l damage of radiological significance would be to the integrity of its 56 1 = .=

a j j concrete sh kiding. Analyses of reinforced concrete irradiator shields designea to meet generally accepted building code requirements for rein-forced concrete have shown they are inherently quite robust and resistant to damage from moderate-size earthquakes. To protect against large earth-quakes, the NRC decided to include requir'ements that radiation shields in seismic areas be' designed to retain their integrity after a large earth-quake. Also, all irradiators must ha'.e an emergency procedure for earthquakes. r B. Use of cesium sources. The two radionuclides generally used in gamma irradiators are cobalt-60 and cesium-137. Cobalt-60 is in the form of solid metal pellets that are relatively insoluble in water. Cesium-137, on the other hand, is generally encapsulated as a salt, cesium chloride, that is fairly soluble i in water. Therefore, cesium-137 could b'e more dispersible than cobalt-60 if the sealed source leaked or was damaged., The question considered is should use of cesium-137 sources be permitted.at all or permitted only with certain additional restrictions? In 1988, a cesium-137 source at the RSI irradiator in Decatur, ' Georgia, leaked. No radiation exposures in excess'of NRC's limits l l occurred, but the leak raised a question about the integrity of' cesium-137 sources. As of July 1990, the cause of the leak is not known and is still being actively investigated. The NRC intends to reevaluate whether cesium-137 sources or sealed sources:containing readily soluble or dis-persible material are suitable for continued, long tern use in irradiators. The Commission specifically_ seeks public comment on this matter. 57

l C. Seismic detection and resistance, j L -As a related issue to siting, NRC considered requirements'for a seismic detector whose activation automatically causes the source to return to its fully shielded position. Such a. requirement is containec in the ANSI Category IV Standard and is general practice. However, ths detectors and sou te return mechanism would not improve the. safety of large irradiators because shield walls must be designed to provide ade-quate shielding to protect workers and the general public in the event of a seismic event. Therefore, NRC concluded that such a requirement is not necessary to protect the public health and safety. Public comment is specifically requested on the need for a seismic detector and artumatic source return mechanism. D. Decommissioning. The NRC considered whether special design requirements were needed to facilitate decommissioning of the facility. The NRC concluded that the requirements in the proposed rule are adequate to facilitate decommission-P ing. Normally, decommissioning is relatively simple, because there would' 1 be no radioactive contamination present'in tho' facility.. However, contam-inntion could be present if leakage of the sources did occur. If leakage from sources did occur the periodic leak tests of dry-storage sources and g monitoring of the pool water shouTd allow early detection of the leakage before large amounts of material ~have leaked out. With early detection of leakage, a leaking source.could be identified and isolated and pool cleanup would purify the water, removing contamination from-the water. Thus, even if a leak occurred, there is little likelihood that contamina-tion would reach high levels. In addition, the pool walls should prevent l-l 58 e t e w w ~e---o-a--r, -wna-. ---s~s = ~= w--' ,,-w-

contamination from leaking out of the pool if contamination occurred. The pool must also have a liner or a surface relatively easy to decontaminate. Thus, an irradiator designed, licensed, and operated in accordance with the proposed rule should facilitate deco... amination. The subjects of financial assurance and recordkeeping for decommis-sioning are adequately dealt with in another section of the regulations (10 CFR 30.35) and thus are not included in Part 36. E. Drop of source rack. The NRC considered whether the drop of a source ~ rack in the pool, caused by cable failure for example, might damage the sealed sources. Cobalt 60 sources'are fcitly light. -Thus..in a drop the source rack would drop relatively slowly through the water anti. hit the pool bottom with little momentum. Cobalt-60 source racks are also generally designed with l plates to slou Ge rate of descent. Thus, the sources are unlikely to be l damaged as a result of a drop, Cesium-137 sources, on the other hand, are relatively heavy so that damage to a. source as the result of a drop might be more likely. However, in eith6r. case it was decided-that.it would be appropriate to analyze the consequences of a source rack drop and design the facility [ to prevent damage to the sources from a source rack drop. Therefore, the l requirements on design include a requirement to analyze source rack drops and to design irradiators to prevent damage to the sealed sources. F. Aircraft crashes. l = l The.NRC' considered whether there should be a prohibition from locating l irradiators near airports because'of risk.of an'irradiator release asso-ciated with an. airplane crash. The NRC has' concluded that.a prohibition 59 9 -w v. 3 .4-een. ,-ws.w t

i l isnotjustifiedonsafetygrobnds. Tb: cadioactive sources in an l irradiator would be relatively protecced from damage because they are ) typically centained within six-foot chick reinforced-concrete walls.and are encapsulated in steel. However, if a source were damaged as a result of an airplane crash, large quantities of radioactivity are unlikely to be spread from the immediate vicinity of the source rack because'the sources-are not volatile. Since the radiological consequences of an a(rplane crash at an irradiator are not likely to be life-threatening, the radio-iogical consequences are relatively unimportant compared to loss of life I directly due to the crash itself. Thus, the presence of radioactive sources does not.substantially change the probable consequences of an airplane crash.' Therefore, NRC will allow the. construction of.an irradi-ator at any location at which local authorities would allow any type of industrial facility to.be placed. G. Pool water coolers. The NRC considered whether pool' water coolers should be required. Pool water coolers would lower water'tempe.ratures, reduce. evaporation, and thus reduce humidity in the air of the radiation room. Lower humid-ities might result in somewhat less potential for corros'in of safety interlocks, product conveyo* systems, and source raising aid lowering mechanisms. -The NRC has decided not to require pool water coolers because there are many ways to avoid problems with high humidity'and many smaller large irradiators do not have humidity problems. In addition,;1icensees would be required to maintain the facility to ensure compliance with the require - ments of 6 36.61 regardless of potentialoproblems' associated with high. humidity.: 60 -,~w ,r ea s e

d j H. Noxious gas control. large irradiators can produce ozone.in concentrations exceeding thase: permitted by regulations of. the OccupationalsSafety,a'nd Health Administra-tion (OSHA)-at 29 CFR 1910.1000, " Air Contaminants." Nitrogen oxides can-also be produced although concentrations would not be expected to exceed q OSHA's limits. To control these noxious gases,' cost radiation.-rooms:are i .equ pped with ventilation' systems to exhaust the gases before personnel entry. The NRC notes t. hat' 0SHA regulates-exposure to ozone.and,other noxious gases. However, if NRC personnel anticipate-a p'roblem-during licensing or ] note a problem with ozone at antirradiator during insoection', the NRC willi notify OSHA of-the orotiem under the terms-of a " Memorandum of'llnderstand-ing.etween the Nuclea. Regulatory Commission and the Occupational ~ Safety 1 a F and Heat 4 Administration; Worker Protection at NRC-Licensed Facilities, ] (53 F ~ -,J590; October 31,.1988). I '. Issuance of a regulatory-guide. The NRC plans to. develop.a regulatory guide that will set'forth the information that an irradiator license' applicant should provide in its'- license application.- :Developent of the guide willfbeginLafter public-comments on t h ' proposed rule have been reviewedi.NRC intendsito issue ~. the' guide in draft form for p~ublic comment-before:the fin 61. irradiator n rule becomes effective. The guide would replace the' draft irradiator. licensing guide.nowlin use. c L i or 61' l.; e s

~, -. 1 IX.. AgreementLState Compatibility. =l 'The rule will be a matter of compatibility between the GC and the Agreement States, thereby providi,ng' consistency'between Federal and. State . ith regard.-'to basic radiation standards and'defit.i-safety _ requirements. W E tions, as foun'd in 10 CFR Part 20,; which lhavc' b'een identified as strict. q matters of compatibility with; respect to Agreement" State regulations, ina i this area.the' Agreement StatesJare expected to adopt essentially-antiden-t* ~ ' standarde iHowever, this'ryle E while b'ei_ng a matter ofLcompatibility, I Ne'NRCandthetAgreementlStatespis:assigneda-levelofLcompati-ll m eer N .ich would e low the AgreementLStates to adopt, additional' require- .ments: based on-local; concerns. Lor experience.u 'X.: : Findingfof. No Significant Environmentaldepact:- Availability' TheCommis'sionhas'determinedLunderatheNa'tionallEnvironme'nta1LPolicy ~ Actof1969,asamended,andth'e' Commission'svregulationslinSubpar.tAof-0 L -10 CFR Part 51,1that this rule,qif ado.pted,,_would-not;beia major Federal u a i action significantlylaffectingLthe qualityif the.huma'n' environment ~ and - ] therefore'an environmentalLimpact(statement is-.not required.. The proposed-L action codifies'in a-rule the-licensing req 0irements )id policies on'large o irradiators.1. :The-proposedactioniisdirectedto-improvingtheregulatory, 1icensing,, inspection,-and enforcement framework relating to these;irradi-ators and will'.not affact the. quality of the human environment. The envi- ,i U-ronmental Assessment ard finding of no significant ' impact an whit.ii this-determination'is based are available for inspection at the NRL Public Document Room, 2120 L-Street NW. (Lower Level),;V shington, DC. Single u 62 a u w ~

+ i copies are available-without charge ~upon written request from NRC. Distribution Section, Office of Information Resources Management, U.S. - Nuclear Regulatory Commissionc Washington, 0C'20555.. 1 -XI. PaperworF Reduction Act Statement i This proposas rule amends information collection: requirements that are subject to the Paperwork Reduction Act of>1980!(44=U.S.C;'3501 et seq.). This rule has been submitted to the Office.of Management and 1 Budget for review and;apnroval of.these requirements.. Public reporting burden for'this collection o'f information is estimated to. average 750 hours'per response, including the time for j reviewing' instructions, searching existing _. data sources, gathering-and maintaining the data-needed,"and completing and reviewing the collection' of information. Send comments regarding'this-burden estimate or any'other i aspect of this collection' of information, including. suggestions for reducing this burden, to the Information and Records Management Branch.(MNBB.7714), U.S. Nuclear Regulatory Connission,. Washington..DC 20555; and'to:the Desk - Officer, Office of Information;and Regulatory Affairs,lNE08 3019, (3150- ),ManagementandBudget,' Washington,. 00 20503. a ti i 1 63 .'l . i: w t i k

iL e i XII..RegblatoryAnalysis The Commission has prepared a' draft regulatory' analysis on.this' proposed regulation. The analysis comparesithe costs and benefits of the requirements.in:the rule with' current' licensing' requirements. The draft-analysis is available for-inspection in the:NRC Public Document' Room,;2120 L Street NW..(Lower Level), Washington, DC.; Single copies of the analysis ] may-be:obtained with'out charge upon written, request from: Distribution' Section,10ffice of N ?ormation. Resources Management, U$tRC, Washington, 00.20555. Comments on the m alysis.,may be submitted' a the NRC as.indi-cated under the ADDRESSES heading.~ l XIII. Regulatory. Flexibility-Certification a 1 As required by-the Regulatory Flexibility:Act20f 1980' 5 U.S.C. aa 605(b), the : Commission-certifies that this rule,L if-adopted. will-not Lhave a:significant economic impact upon'a's'ubstantial number,of'small j n entities'. Currently.thereareroughly470to,80/irradiatorsthatarelarge irradiators, a's defined by the' proposed rule ;0f!those irrc rs,. there are currently 39 irradiators in the'U.S.L with sourcestgreater than-250,000 curies (9.x-101sbecquereEs)'uptoa.maximumof. 30,000,000 curies-(1.1 x!1018 becquerels)P Fifteen.are licensed by NRC; 24 tare licensed'by. L i Agreement States. !Five= additional irradiators are;either uncer construc- ' <.e tion or pronosedLfor construction in' Agreement Stat'es. Inladdition,Lthe NRC: licenses ~ 10cirradiat' ors with sources smaller?than 250,000 curies. 4 (9.25:x"1015 b'ecquereli) that would be. subject to-the rule. The: Agree-t ment States probably have about twice as:many.of these " smaller" large + '*i i s m lh 5 i al

i

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irradiators. Thus, the total number of facilities that would ultimately [ be affected by the rule is roughly 70.to 80. All'the irradiators use i cobalt-60 except for four which use cesium-137. In addition to.these irradiators, Congress has appropriated money to theLU.S. Department'of? Energy to' support the construction of'six;irradiators to be used in fooo-processing. The food irradiators would be licensed by-NRC;or by Agreertent States depending on their~ locations. The NRC currently: defines a small; business as a business having;1ess-s than $3.5 million in. annual receipts.' Some of the licensees that would be affected by tHs proposed rule might be small entities. However, the actual financial impactscof.the.propcsed rule would.be quite small..A! survey of irradiators performed for the previously mentioned Regulatbry Analysis indicatea that~, with minor exceptions, all surveyed licensees-areincompliancewithmostoftheLrequirementsofltheproposedtrule. The proposed rule contains options:suchLthatithe.six-licensees found;not-to be'in' full compliance with-the: proposed: requirements couldl limit their incremental costs to $2',000' to-$5',000,. estimated as part of the previously mentioned Regulatory Analysis. 'These costs are not considered'significant. Thus,.the proposed rulefwould not impose; a significant econe.nic impact on small entities, as. defined 11n the: Regulatory: Flexibility Act of 1980,-because the prcposed requirementsido.'not sub'stantially differ from current licensing requirement,'T s Any small' entity affacted by.t5is: regulation,which; determines that,- because of its size, it is likely to bear aidisproportionate; adverse economic impact,-should notify the Commiss' ion of;this.,in~a comment that-indicates the following:: d (a) The small-entity's. size in terms of annual income 'or revenue and : 1 number of employees; -65' i a

i- .-l (b) How-the proposed' regulation wo01d result italsignificant l economic burden upon the.small' entity asicompared to that on.a larger- . entity;

l (c) Howthe.-proposedregulationscouldbemodifiedtotake(into.

account the etitity's differing needs;or' capabilities;. (d) The' benefits that would be gained or;t'he' detriments that wc01d! L be avoided by the. licensee if the proposed regulations' were modified'as: suggested;;and _'(e)(Howtheregulation,.as,modihiedLwouldstill'adequatelyLprot'ect T .the public. health and safety. n The comments should be sent to theTSecretary of the Commission, U.S. Nuclear _ Regulatory Commission ~, Washington, DC 20555, ATTN:] Docketing and- ~ Service Branch. ' 4 XIV. B'ac'kfiti Analyiii q g> j TheNRChasdetermined.th'at:the.backfit~ rule,.10lCFR.50.109'does'not-apply. to this proposed rule and:therefore that a backfitianalysis is-not c a h required-for this proposed r01er ' The propbsed rul'e does not'-involve;any - t provisions that' would-impose backfits asidefined.in 10 CFR;50;109 (a)(1). - XViiLisiof' Subjects N l 10 CFR'Part 19 t* 4 Criminalipenalty, _ Environmental' protection, Nuclear materials, _ Nuclear q h power plants and reactors, Occupationalisafety and health,: Radiation-pro-t a' tection,2 Reporting andirecordkeeping' requirements, Sex discriminatio~n. p 1 L ~66 ,n; x a L-ail : s c ' h' '

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- - q q m I 10 CFR Part 20 i Byproduct material, Criminal penalty, Licensed material,' Nuclear materials, Nuclear power plants and reactors,' Occupational safety and health, Packaging and containers, Radiation protection, Reporting and j recordkeeping requirements, Special-nuclear material, Source material,- l Waste treatment and disposal. 10 CFR Part 30 I Byproduct material, Criminal penalty, Government contracts. Inter-governmental relations,. Isotopes,cNuclear materials, Radiation protection, -Reporting and recordkeeping requirements. 10 CFR Part 36 Byproduct material, Criminal penalty, Nuclear materials-Reporting-i and recordkeeping requirements, Scientific equipment,' Security measures. - 10 CFR Part 40 Criminal penalty, Government contracts. Hazardous materials'-- trans-portation, Nuclear aaterials, Reporting).and recordkeeping requirements, t a Source material, Uranium. ~ 10 CFR Part 51 Administrative. practice and procedure, Environmental impact sta'tement, { Nuclear materials, Nuclear.. power plants:a'nd; reactors,' Reporting'and record-f keeping requirements. jj 10 CFR Part.70-y Criminal penalty, Hazardous materials

transportation,' Material control and accounting, NuclearLmaterials, PackagingJand containers, bdi-a ation protection, Reporting.and recordkeeping requirements,; Scientific; Y

equipment, -Security measures', Special-' nuclear material. J ff 67 i

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-{ j i 4 10 CFR Part 170c Byproduct' material, Non-payment penalty, Nuclear' materials, Nuclear-power plants and= reactors, Source material, Special; i.uclear material. XVI. Wording,of theLProposed. Amendments 7 d for the reasons set out-in the preamble'and under the authori_ty of.- theAtomicEnergy.Actof195',:as. amended'theEnerghReorganization?Act', f 4 ~ 'o* 1974, as' amended; and 5 U.S.C. 553, thel NRC is proposing to:adop't 101 .[ tfR 36 and make the conforming amendments to 10~CFR Parts 19,o20,c21, 30, 40,.51, 70, and 170. 1. Part 36'is added to,10 CFR Chapterilito~ read las Yollows':. Fart 36 - Licenses and Ridiatibn Safety Requirements for LargeLIrradiators i { cc i. 't Subpart A'- General ~ Provisions' T + Sec. t. b 36.1-Purpose and scope, i 36.2 ' Definitions'. L 36.5 Interpretationsi-36.8 ~I'nformation collection requirements:: 10MBla.pproval. '] y 'Subpart S

• Specific: OcensinaRequirements' m

36.11;

Application for a specificilicense.:

\\; f ..' 3 6.13. Specific licenses for largetirradiators. 36.15-LStart of construction. 4 'a -68 1 + b b-L ,1.f,'i), j[3 I 3.#; { , h '/ l } }' i / l t ih. 'h -- ..L O ; ' ,j a._ _,1 - i - = I 1 ,,..i ' d ; ; __ _,, m m

a v 4 36.17 Applications for exemptions. 36.19 Request for written statements, q i. ' subpart C - Desion and Performance Requirements for Large Irradiators 36.21 Design and' performance criteria for sealed s'ources.. . 36.23 Access control. 36,25. . Shielding.= ~ ire protection, 36.27 F m, 36.29-Radiation monitors.- .} 36.31-Control of source.mo'ement z v . 36J33 Irradiat'or pools. 'l

36.35

- Source rack protection. 3 I 36/37 Power failures.: a -36;39 Design requirements. 36.41 .Constructionicontrol. \\ r Subpart 0 - Operatio.a of Laroe'Irradiators 36.514 Training.. 3i 36.53 Operating and emergency:p'ocedures. f r 1 36.55 Personnsi monitoring.t E - 36.57

Radiation surveys.

36.59 Detection of leaking'or contaminated sources.. I 36.61 ' Operational inspection and maintenance. s 36'.63- - Pool ~ water' purit9 . 36.65' ! Attendance:during operation: 36.67' Entering and leaving theLradiation room. y i - 36.69. Irradiation of. explosive orfhighly flamable materials.- l T 1 y s S,

69

+ Iyt' i ;., 6 4 4

n Subpart E ' Records and Reports? 36.81-Records and retention periods. 36.83' Reports. Subpart F -1 Enforcement .36.91 Violations.. 4 Authority: Sees.81,82L161',,182,2183,IB6,=68 Stat.935,948,:953,- 954, 955;'as amended,; sec.J234', 83 Stat. ; 444',; as', amended -(42 U.S.Cf 2111,; 2112, 2201, 2232, 2233',J2236;:;2282); secs. 201, as amended, 202, 206, 88. Stat. 1242, as amended,L1244, 1246:(42'U.S.C. 5841n 5842,15846). For the purposesi.of sec. 223,L68; Stat. 958,=.as amended-(42 U.S.C. .2273),:all'the provisions:of-this part are issued under Sec. 161b, 68 Stat.948,Jasamended(42=U;S.C.~2201(b))sS'ec.f1611,68? Stat.949,-as. im 1.. amended'(42U.S.C.-2201(i));and:sec.1161o,L68: Stat.;950;"as' amended l(42 U.S.C. 2201(o)) except1the-followin'g provisions: 10;CFR $$i36.5,-36.8, ~ .and'36.91. Subpari A - General Provisibns 1 5 36.1 Purpose and' scope. (a) This part contains requ'i'rements for the issuance'of:a license' authorizingLthe use.of sealed sources containing radioactive materials in .large irradiators used'to ' irradiate.ob.jects or materials. 'This part also: contains radiation safety re4uirements for. operating large irradiators. The.requ' ements.of this part, are in addition to othea requirements of this chapter. In particular, the provisions-of' Parts 19. 20, 21, 30; 71, 10 m u, y. JV b.

x and 170 of this chapter' apply to applications and licenses subject to' -this'part. (b) The regulations in this'part apply to large~ panoramic irradiators-q that have either dry or wet storage of the radioactive $Mled sources.and to large underwater irradiators in which_both the; source and the product being irradiated are underwater. Large irraciat' ors covered by the regula-tions in thislpart are those'where radiation; dose rates exceeding 500: rads (5 grays) per hour exist-at.one meter from the. radioactive sealed sources [" in air. or in water, as applicable forsthe irradiator type. (c) The regulations in'this part dot not ap' ply to self-containe'd-dry-source-storage irradiatert those in which both the. source and the ~ area subject to_ irradiation are contained within a device and are not. accessible by personnel), medical radiology =orLteletherapy,' radiography-(the irradiation of materials forino'ndestructive!testin~g purposes), gaug-l ing,1 calibration'of radiation detection instruments,'or.open-field (agricultural) irradiations.. q .S 36.2 Definitions. Annually means once each calendar yearf and at intervals-not to exceed one year. Doubly-encapsulated sealed source means aisealed source in which'the- ! radioactive. material'is. sealed within a capsule and thatLeapsule'is sealed i within another capsule.. N Irradiator means a facility that uses radioactive sealed sources:for the1irradiationofobjectsormaterials. Irradiator operator means an individual authorized by the lics 9 to -operate the irradiator. l !.l 71 ,g e

i.,A N

.L 'O =

1 L o '1 h . Large:irradiator:means:an irradiator where radiation dose' rates. j l exceeding 500 rads-(5 grays) per hour. exist at-one meter'from the sealed q - radioactive sources in' air l or -water,: as applicable for the. irradiator type, but does not include irradiators in which both the sealed source'andi he-t area subject to irradiation :are contained within aldavice and 'are not - i accessible to personnel. Panoramic dry-source-storage 1ieradiator!means ~ an irradiator'in which the irradiation's occurlintairLin areas-potentially accessible lto personnel and in which the: sources'are stored in. shields made-of solid materials. The term also includes tieam-type dry-source-storage irradiators invi h c the source remainkpa'rtially: shielded during irradiations.- (Panoramic' irradiator'mean's tan irradiator in' which theoirradiations: . are done in a'irJin areas potentially accessible to personnel. : The term includes. beam-type irradiators' ' Panoramic' wet-sobree-storage.irradiator means Lan irradiator in which - i t . the irradiations occur'in air Lin.ar.e'as potentially accessible to personnel and'in which the sources are stored underwater in a storage' pool.: Pool irradiator meanslany irradiator at which ibe-sources are stored ' or used inia pool. of water including panoramic wet-s'ource-storage' irradia-tors and u'ndemater irradiators. -Product conveyor system means:a system for moving the product to be irradiated,to, from, and within t'h'eTarea whereLirradiationJ akes; plate.. t Fudiation room means' a shielded room in which irradiations >take place.. Undemater irradiatorslare not' considered to have rattiation rooms. Radiation safety officer means an individual;with responsib'ility for. ~ .l the'overall. radiation safety program at theLfarflity. '72 4 3

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r Sealed source means any byproduct m terial that is used as a source' l c l of radiation and is encased in a capsule. designed,to' prevent. leakage or escape of'the byproduct material. Seismic area means any areaLwhere the probability.of a horizontal c L acceleration in rock of more,than 0.3 times the acesleration of gravity in 250' years is greater than 10. percent, as designated by.'the U.S._ Geological J Survey. J Underwater irradiator means an irradiator-in which the sourcestalways remain shielded underwater and humans:could not' access the sealed sources-and the space subjact to irradiation without entering-the'. pool. y \\ ll36.5-Interpretations. Except-as specifically auth-ized by? thel Comissiont in writing, no. interpretationofthemecningoftheregulationsLin.thisepartby.anyoffi- [ L car or employee of the Comissioni other thanf a written? interpretation by. q t: L the General Counsel, will-be recognized to be binding upon the Comission. 't i 36.8 Information collection requirements:. OMB approval. (a) The Nuclear Regulatory Connissionlas suba.!ttedctho'information l -. collection requirements contained in this partitolthe (ffice of Management-and Budget (OMB) for approval as required by the PapenerkWiuction Act .of1980(44U.S.3501:etseq.). OMB'has approved-.thelinformation collec-tion requirements contained in thisLpart under control-number'3150- .(b) The4 approved information collection requirec.erds contained-in this part appear in il 36.11,'36.13, 36'.19, 36.21, 31.61,:36.69,-36.81, and 36.83. (c)-Thispartcontainsinformationcollectionrequirements:in i / u addition to those approved under.the controi number specified in paragraph l j .i 73 . ll. -.. J.. .w: L

g u d I -(a) of this'section. These information collection requirements and the. y control. numbers ~under which they:are approved are as'follows:' l (1) In S 36.11, Form NRC-313 is ~ approved under control number ' 3180-0120.' s i Subpart B Specific dcensino Requirements r i R LS 36.11 Application-for a spedific license. 1 Apers'ontas-defined; ins 30.4:ofcthisihapter,mayJfile~an -applicationLfor a' specific license'~authorizint the use of: sealed sources in:a'large irradiator.on Form NRC'313,1 Application for Material: License." Each application for a license,'other-than:a license exempted from:Part' 1170ofthischapter,must-beaccompaniedbyth'e fee;prescribedinl$170.31 .of this; chapter. LThe! application must be/sent to the appropriate hRC 'I 1 I . Regional-Office listed in Appendix'0 to rt 20;of this chapter. I S-36.13.. Specific licenses for large irradiators. y The Commission will approve an: application for. a specific licenseifor i the use. of' licensed material,in largelirradiatorstifithetapplicant meets 7 the requirements containedtin:this section.' '(a).1The applicant shall/ satisfy' the general requirements specified s in 6 30=33 of this. chapter and the, requirements: contained.in this part. (b) The applicant shalladescribe;its training for,irradiator opera-tors that specifies the-- (1) Classroom training; i (2) On-the-job training;: (3) -Safety reviews; -y f m -74 /

)

4 1 y 3

~_ f (4)' Means the ap'plicant will use.to demonstrate the operator'( ~ ~ q knowledge and understanding of and ability'to comply with the~ Commission's regulations and licensing requirements and the applicant's; operating and: emergency procedures; and-(5) Minimum qualifications of: personnel who may provide training. (c) The applicant shall submit an outline or summ*,ry c' the written i operating and-emergency procedures listed in S.36.53. The outline or s'um-l mary must include-the important radiation safety' aspects of the procedures. (d). The applicant shall' describe the radiationisafety l responsibilities and authorities of ~ the radiation. safety officer and- [ other management personnel. :The a'pplicant'shall also describe the-i qualification ~s required' of the ' radiation safe'tyfofficer. (e) The applicant for a' panoramic irradiatorlshall submit-a f ~ i description of the access control-systems required ~by $136.23, th'e radia-tion monitors required by S'36.29 and a diagram of the' facility that- [ shows. the position of :all required interlocks and radiation' monitors; ~ L (f) If the' applicant intends to; perform leak testing of dry-source-storage sealed sources, the: applicant sha11' establish procedures for leak i i testing and submit a description of:th'se;procedu'res toi he Commission. e t i L The description-must include the-- i (1) Instruments to be used; ~ i (2) l Methods of performing'the' analysis;'and l (3) Per'c.ient experience of tthe: individual who analyzes the samples ~.. (g)..If license'e personnel are to_ load.or unload sources, the I [. applicant shall describe the qualifications of the personnel and the pro-i c'edures to be used; If the applicant intends to contract for source load- ~ y ing or'unloadingiat its faci.lity, the. loading or unloading.aust be done by.. 4 75 i 10 g 1

4 y L F an.organizati.on approved by.the CommissionLor:an Agreement Statetto load

• i i

or unload irradiator sources..

(h):-The' applicant shall describe the operational inspection and maintenance program, including"the frequency of the' operational che'cks' ) required by 6 36.61. l 6 36.15 Startiof construction. 1 Theapplicant1shallnotbegin,constructionof'a'newfaci[lity; prior? to'theissuance-ofalicense;forfthefacility.'AsLusedin.this(paragraph, the term " construction".includesjthe-construction offany portion-of the,

permanent facility:on the site but.does nothinclude:- engineering and.

C .i j design work, purchase of~a site,isite surveys or:Lsoil testing,(site pre-4 + paration, site; excavation,.constructionofwarehousestructures,fand.; ~ other similar t' asks.=2Any activities-undertaken l prior to.the:is'suance of. a license must be entirely attthe risk-of the applicant and have:no bear- ~ ing on the issuance of a license'with. respect:toithe requirements'of the'. j . Atomic Energy Act of 1954, as amended,cand rules,. regulations, and orders t promulgated pursuant thereto.: m 6 36.17 Applications for exemptions. - The Commission may, upon application-of any interested person.or upon its own initiative,, antiany. exemptions from the rewhaments in this + part that it determines -are authorized by: law and will. not' endanger. life or property or the common defense and security and are othemiseoin the 1 .public int'erest.- I f 76 t e ~ - ,v e E +m n,l m-- eme - +- ,v n+e 6e 0 6 e* 2g+ -+

. ~. 'e $-36.19 Request for written statements. 1 Each license is issued with the condition.that the: licensee will, at any time before expiration of.the, license, upon the Commission's request,- l submit written statements, signed under: oath or affirmation, to enable the Commission.to determine whether or not the license should be modified, suspended, or. revoked. i 1 ) Subpart C - Design and' Performance Requirements for.Large'Irradiators g - t f 6 36.21 Design and performance' criteria for' sealed sources. -(a) :The licensee shall assure that sealed's'ources; installed after ~ (effective date of rule) meet the following requirements. ~A-prototype of-the sealed source must be leak tested.and fo'und leak-free lafter' each of the,following tests: L (1) Temperature. The test source must be held at'-40*C for.20-e i minutes, 600'C for.1, hour, ~and then be subjectet to a thermal shock-test wit: a temperature dropffrom 600*C to;20*C within-15.econds. (2) Pressure. The test source must.-be ' subjected to an external ~ c . ? - pressure of 290 pounds per square inch absolute. (3) Impact. A 2 kg: steel weight, 2.5.ce ;in: diameter, must be ~ dropped from a height of 1 m onto the test source.- l (4) Vibration. The test'so0rce must be subjected to a vibration q from 25 Hz to 500 Hz at-5 times the acceleration of-gravity for 30 i L minutes.

(5) Puncture.

A 50 gram weight and pin, 0.3 cm pin. diameter, must-be dropped from a height of 1"m onto the test source. (6) Bend. If the length of.the source.-is more than!15 times.largar than the' minimum cross-sectional dimension, the test source must be. i 77 q. 2 4

~.. , k t l: subjectedtoalforceof2000.newtonsat=itscenterequidistant-fromtwo' support cylinders,-the'dista'nce between which is.10 times the minimum l cross-sectionaldimensionofthe?sourcek '(b) Seal'ed sources inst'lled afterL(effective.uate of rule) must be a I doubly encapsulated and"must'have a. certificate ofEregistration as required-j e by 10 CFR.$ 32.210. l l l _ ? 'S.36.23 Access control.. (a). Each entrance:toLa radiation room'at a phnoramiczirradiatortmust have a door or other physical! barrier $ o. prevent ina'dvertsid ent'ry;ofc pera ~ t u sonnel while the sources are exposed. LItimust not be.possible-to!mbe the ~ sourcesoutof'their. shielded: position.iftthedoo'r.or[ barrier'is-open.. J Opening the door orpbarrier while.the sources:are exposed.must;ckuse the . sources to return to'their shielded position _. The'timeLfor the. sources.to return to' the shielded position mustt beiless than.orJequal to the time thatL l it would take'a personistarting to enter.the radiation room.to walk to'the edge of the pool or into the beam (as applicable for irradiator thpe); 1 The primary entry door' must have a' lock that is' operated'by the'same' key' d used to movet the sources. The doors' an'd barriers:must'not prevent any individual in'the radiation room from leaving. (b) In addition, each entrance to a' radiation room at a panorami.c. -irradiator must have an independent backup' access controlJto detect per-sonnel entry while the sources are exposed if the primary access control fails. Entry while'the: sources are exposed must cause the sources to return to their fully shielded position and must'also activate a visible and audible alarm to make the individual. entering the' room aware of the-hazard. The alarm must also alert at least one other individ'ual who is $G 78 ^ 'f-J \\ ; d' U 5 '... ..,._.....4.._s, ,_,,._,,,,,,..,.y ,.,,y., . b -. ,i

en site of. the entry. That' individual shall be trained and prepared to promptly render 'or s'ummon assistance.'.

i (c) A radiation monitor must be provided to detect the presence of radiation'in the radiction room of a panoramic irrediator before personnel 1

entry. The monitor must'be'integr'ated with personnel access door locks =to f prevent room access when the' monitor detects high radiation tevels, mal-- -functions, or is turned off. The monitor must generate audifle'and'visi-ble alarms-if high radiation levels are detected when personnel: entry is attempted. The monitor may.be located in the entra cel(normally~ referred to as.the maze), but not'10 the direct radiation-beam, i (d) Before the. sources eve frem their' shielded' position in a panoramic irradiator,, the source control must automatically activate con-spicuous: visible-and audible alarms to alert ~'peopli initne radiation room 7 that the sources will be moved from.their shielded position. The alarms must give individuals enough time to leave th'e room before thel sources leave-the' shielded position. -(e) Each radiation' room atla' panoramic irradiator' must have a clearly visible and readily accessible controlithat would. allow an individu'allin the room to make the sources return to their' fully shielded positi'n. o (f) Each radiation room of a panoramic irr6diator must contain a control that allows the sources to. move _from the shielded position only-u if the control has-been activated'and'the door or: barrier _ to 'the radiation roomhasbeensubsequently~closedwithinalpresettime. (g) Each entrance to the radiation room of a' panoramic irradiator-and each entrance to the area within the personnel access-barrier of en underwater irradiator must have a sign bearing.the radiation symbol'and the words, " Caution (or danger) radioactive material." Panoramic irradia-c tors must also have'a: sign stating "High radiation area," but the' sign may 79' +--- -- m .-r .v. -.+.--

3..

i be removed, covered, or otherwise;made inoperative'when the sources are fully shielded.' -(h)' If.the. radiation room of a panoramic'irradiator has roof plugs or other movable: shielding, it'mustinot be.possible to operate thejirradi - ator:unless th'e shielaing-is in?its; proper 31'ocation. This requiremente may be met by interlocks that' prevent operationiif. shielding is not,placed properly or by an operating proceduref requiringfinspectionLof shielding before. operating., (i) Panoramic irradiatorsimay not. operate-ifethe requirements of this section are' not raet.. (j) Underwater irradiators;must have a personnel access barris aroundithe. pool that can becl.ocked to preventLaccess when the irradiat'orl l is not' attended....Only operators'andtfacility. management'may have access-i to keys to the personnel access barrier. (There must be1an intrusion alarm L p -to' detect unauthorized entry:when the personnel access barrier is locked. Activationiof the intrusionfalarm'must alert an individual. (not necessarily, p onsite)whois4preparedtorespondforfsummon: assistance, c a l S 36;25 Shielding.: (a) The radiation' dose rate'in ' areas triatTate(ac'cessible during I L. operation of a panoramic irradiator must not exceedl2 millitems-(0.00002L - sievert) perc hour at 30 centimeters.or inore-from 'the wall: of-the room when l i s L b thesourcesareexposed'.L.'TheidoseirateImustlbe'averagedSeran"areaTnot tolcxceed 100 square centimeters 'havingin$ 1,inear dimension greater' than-I reaswherethearadir.tlondose;ratewxcess.2milliress(0.00002 [ ,20 cm. i sievert) per hour-mustibe locked to. prevent access and not entered without L . ritten approval of. the radiation' safety officer, ~ w p 3 I .gn; a, l- 'i' o ~ 'L n_ I' \\ a s .. ! l ,-..._...4 .;,. ;,J.,.. ).. '? t

L -(b) The radiation dose rate'at'30 centimeters over the pool of a. pool irradiator when the source is i; the~ fully shieldad position must not xeced 2 millirems (0.00002 sievert) per hour.1 -(c) The radiation dose rate at 1 meter from the srteld of a dry-source storage panoramic irradiator must.not exceed 2 millirems (0.00002! l ~ sievert) per hour.and at 5' centimeters from'the shield'must not exceed 20 - i millirems '(0_.0002-sievert) per hour. D 6 36.27 Fire protection, (a) The' radiation room'at a panoramic irradiator must have heat and c l p smoke detectors. -The detectors-must' activate an audible. alarm. ;The alarm must be capable of alerting a. person who is prepared;to summon assistance 2 promptly. TheLsources must automatically become fully shielded if a fire tis detected. l (b) The radiation: room'at a: panoramic irradiator must-be equipped ) with -a. fire suppressiorior extinguishing:systemL capablei.of extinguishing f u a fire without'the entry of personnel ~into!the room.' .S 36.29 Radiation monitors. (a) LA: radiation monitor with an audible" alarm must--bellocated to- - detect loose radiation sources:that areicarried.toward the product exit.-- e, l; If the. monitor detects a source,,an alarmJmust sound and product conveyors must stop automatically before radiation from the source could cause:any 4 -individual-to receive a radiation dose exceeding 100 arem. The alarm must be, capable of alerting an individual in the' facility who Lis prepared to ' summon assistance. Underwater irradiators in which the product moves 4 within"an enclosed dry tube are exempt from the requirements'of this-m l paragraph, pE 81 4 w m-e e a w a we a mg-ss %-w m-rg &y a,p+ gn.-eg 9 e --gy--m p9,,

2 1 1 ; q } i s/ ^ i I; (b).- For pool irradiatorsnthe licensee shall; provide a means to: detect radioactive contamination in oool waterjea: byjtheirradiatorJ 4 _ operates.u The means may.be either an online radiation'm'onitor on a pool- ~ 1 L L water purification: system or an analysis'_of pool ~ water. LIf; the licensee L J uses an on'line radiation;monitore ths detectionLofiabove' normal; radiation' >"t levelsmust:' activate (analarm.;:The.alarmfsetpointmustbesetaslowas practical,'butlhighlenough to avoid false: alarms.:?Ifia false alarm due to-i q background-radiation' occurs, thef alarm' set-point. mustLbe increasedh Acti' vation of the.' alarm'must-l automatically cause the waterJpurification sys'temi i toshut(off.9However,ithelicensee'mayresetthealarmsetpointtoa- 'i higher-ISvelif~necessarytooperate1thepoolwaterpurification..systemto.. clean up contaminationiinLthe pooll ast specifically;provided in written. 1 emergencyJprocedures. 1 b Underwater irradiators that'are not iroa shielded radiation room T(c) m must have a radiation monitor;over!the poolftotdetect. abnormal radiation t i Themonitormustih'aveanaddiblesalarmandavisibleindicator j levels. 'at entrances.-to Lthe personnel access barrier around the' pool.. :The: audible 1 -alarm may' have a manual shut off., Theialarm mus't be capable:of alerting - 1 g anindividual'who'isiprepared[ tore $pondipromptlye $.36 31 Costrol of source movement.' (a)? The mechanismithatomoves"the sourcestof a panoramic irradiator must require a key to ope. rate.I0nly one key may beiin use at anyl time, '{ y l and only operators or!facilify management may' possess [it.. The lock must 'be-designed so that itheikey may: not 'be removed'.iflthe: source. is'in en ] unshielded position. dheJdoorsto th's[radiat'ioncroom'must require the. -sanie key. JJ + Y-82 ?, / e y s - A l' I :' 1-l..i - ..a.. s l--- ...J.~,, i ; i m., I

(? 'd g. L L (b) The console'of a panoramic irradiator must have a source position l: . indicator that indicates when.the sources'are.in the fully shielded posi_ - tion, when they dre in transit, and,when the ' sources -are exposed.- 4 I (c) = The control console cf a panoramic irradiator must have a' control i that promptly returns the sources toithe shielded pusition, q (d) Each control for a panoramic irradiator must.be clearly labeled-as.to its function. L (e) Controls for a panoramic.irradiator must'be color-coded'or illuminated as follows: ~ red represents:emergencyE(stop buttons or_ lights) orritical information (source in.use or.:. malfunction); yellow orlorange c represents caution (no emergency b'ut some' function taking place to be - aware of); green or blue-represents normal or safe functioning or infor-mation (source not in ust or function' safe). o q i -S 36.33 Irradiator pools. (a) For licenses initially issued. aft.er (effective date of rule) irradiator pools must either: (1) have a water-tight. st'ainless steel liner or a. liner retallurgically compatible with1other components in the i pool, or (2) be constructed so~ that there is,a low ?likelihebd'of substan-tial leakage and have a surface designed to facilitate decohtamination. ~ In both cases irradiators must include a means of ~ safely stating the sources during repairs of.the pool walls. (b) ~ For licenses initially issued af.ter -(effective date of rulh) irradiator pools must have no penetrations more~than lifoot-below tl.nor-mal low ~ water level that could allow watersto: drain out of the pool.. Pipes h thathaveihtakesmorethan1footbelow,thenormallowwater.levelmust .have siphon breakers to prevent the syphoning.of pool: water lower that 1 footsbelow the-normal: low water level. 83 [

R g 4 e ..1 (c) A means must be-provided to replenish water losses from the pool. ~ 'l (d) An.audibleand~avisi,bleindicator.'mustbeprovidedtdindicateL q - if the pool water level falls below the normal low water level. j L (e) Irradiator pools must be' equipped withJa; purification system designed tol maintain;the water, under normal circumstances,-at'a level of' q l conductance'not-exceeding 10 microsiemens;per. centimeter.; j l '(f) A phyiical barrier, such as 'a railing or. cover,' must;bezused! around irradiator-pools during; normal. operation toiprevent personnellfrom? ~ accidentally.fallingintothe. pool._Thebarriermayberemoveddur1ing. y maintenance, irispection, and service operationsr ~ ~ M (g). If hollow poles, hollow'long-handled tools, or tools'with:a l l density less than-that'of water are to be:used:infirradiator pools,;.they must.have vent-holes.to allow water to enter them readily and fil1J voids - to' prevent radiation 1streami.ng orithey mustihave sufficient -bends'so that - 6 the radiation levelston'the handling ~ areas of thel tools doTnot exceed'2

{

millirems (0.00002-: sievert)perhour. ]j { 36.35 Source rack. protection. 'If the product to be irradiated moves on a product conveyorJsystem,. the source rack!and the mechanism th'at moves:the rack must be protected by a, barrier or: guides to;preventsproducts and product carriers from .tting-or touching'the. rack or mechanism. S36237'Powerfailures.- -(a)( 'If r,tetrical' power at a. panoramic irradiator is lost for longer - - 3 .than110 secon A the. sources-must.aut,omatically return to the shielded n . position. l ^ - 84 3 a 1 L L ...com d'

5 (b) The lock on the door of the radiation room of a panoramic irradiator must not be deactivated by a power failure. (c) During a power failure, the area around the pool of an underwater

rradiator may not be entered without using an operable and calibretM radiation survey meter.

S 36.39 Design requirements, i Irradiators whose. construction begins after (effective date of. rule) .l must meet the design requirements of this section. The. requirements must be met prior to the start of the construction of the specific component, but do not have to be met prior to submitting a license application. (a) Shieldino. For panoramic irradiators,.the licensee shall design shielding walls to meet generally accepted building code' requirements for reinforced concrete and design the walls, wall penetrations, and entrance-ways to meet the radiation shielding requirements of.$ 36.25. (b) Foundations. For panoramic irradiators, the. licensee shall design the foundation to ensure it'is adequate to support the weight of the facility considering soil characteristics. (c) Pool intearity. For pool irradiators,;the licensee shall design the pool to assure that it is leak resistant,'that it is strong _enough to bear the weight of the pool water and shipping ' casks, that a dropped cask wouldnotfallonsealedsourcesIthat'ithas'no'penetrationsthatdonot meet the requirements of $ 36.33(b), and that metal components are metal-l lurgically compatible with other' components in the pool. l (d) Water handling system. For pool irradiators, the licensee shall design the water purification system to meet the requirements of. S 36.33(e). 85 1

=' (e) Radiation monitors.. For all irradiators, the licensee shall. l evaluate the location and sensitivity.of the. monitor to detect' sources-carried by the product conveyor system as required.by 6.36.29(a). The licensee shall verify that the product conveyor would stop before a source on the product conveyor could cause a. radiation dose to any person-to exceed 100 mrem (0.001 sievert). For pr;l irradiators, the licensee shall verify that the radiation monitor on the water purification system is located near the spot at which the highest radiation levels.would be expected. ] (f) Source rack. For panoramic irradiators, the licensee shall determine that source rack drops due to loss of power will not' damage the source rack and that source rack drops due to failure of cables (or ' alter-nate means of support) will-not cause loss of integrity of sealed-sources. For panoramic irradiators, the licensee shall review the design of the t mechanism that moves the sources'to assure that the likelihood of a stuck source is low and that, if the rack sticks, a-means exists to free it + without causy.n radiation overexposures of' personnel.. (g) Access control. For panoramic irradiators,.the' licensee shall verify from the design and logic diagram that the. access control" system will meet the requirements of 6 36.23.. (h) Fira protection. For panoramic.irradiators, the licensee shall verify that the design 'and locatihns' of' the-smoke and heat detectors.and 1 extinguishing system are appropriate to detect and extinguish fires. (i) Source return.- For panoramic irradiators, the' licensee shall verify that the source rack can be' returned to the fully-shielded position if offsite power is lost or if a component of the return mechanism fails.. The design must allow for. accomplishing the return'without causing radia-tion overexposures of personnel. 86

4 t (j) Seismic. For panoramic irradiators to be built 4 1n seismic areas, the licensee shall design the reinforced concrete radiation shields to retain their integrity in the event of an earthquake by designing to the-y l seismic requirements of an appropriate source such as ACI Standard 318-77, 5 " Building Code Requirements for Reinforced Concrete," or local building codes, if current. S 36.41 Construction control. The requirements of this section must be met for irradiators whose l construction begins after (effective date of the rule). The requirements t of this section must be met prior to loading sources. (a) Shielding. For.. panoramic irradiators, the licensee shall' monitor the construction of the shielding to verify that its construction meets design specifications _and generally accepted building code requirements for reinforced concrete. (b) Foundations. For panoramic irradiators, the. licensee shall monitor the construction of the foundations.to verify that their construc-tion meets design specifications. (c) Pool integrity. For pool irradiators,.the licensee shall verify that the pool meets design specifications-and shall test the integrity of 1 the pool. The licensee shall verify that penetrations and water. intakes j meet-therequirementsof$36.33(N. (d) Water handling system. For pool. irradiators,.the licensee shal1~ verify that the water purification system, the conductivity meter and'the l water level alarms operate properly. (e) Radiation monitors. For all irra.diators, the licensee shall verify the proper operation of the monitor to detect sources carried on i l product and the related alarms and interlocks required by $ 36.29(a). For [ 87 c

t t pool irradiators, the licensee shall verify the proper operation of the radiation monitor on the water purification system and the related klarms and interlocks required by 6 36.29(b). For underwater irradiators, the licensee shall verify the proper operation of the over-the-pool monitor, alarms, and interlocks required by $ 36.29(c). (f) Source rack. For panoramic irradiators, the licensee'shall' test. the movement of the source racks for proper operation prior to source ~ 1 loading; testing must include source rack lowering due to simulated-loss-of power. For all irradiators with product' conveyor systems,.the licensee shall observe and test the operation of the conveyor system to assure that the requirements in S 36.35 are met for protection of the source racks and-the mechanism that moves the rack; testing'must include tests of any limit I switches and interlocks used to protect the source rack and mechanism that I moves the rack from moving product carriers. (g) Access control For panoramic irradiators, the licenste shall test the completed access control system to assure-that it functions as designed and that all alarms, controls, and interlocks-work properly. (h) Fire protection. For panoramic.irradiators, the licensee shall-verify the ability of the heat and smoke detectors;to detect a fire, to activate alarms, and to cause the-source rack to automatically become-fully shielded. The licensee shall also verify the operability of the fire suppression or extinguishing system. L (i) Source return. For. panoramic irradiators, the licensee shall demonstrate that the source racks can be returned to thei.r fully shielded l positions-without offsite power, l-(j) Computer systems. For panoramic irradiators,-if a computer is L l used to control the access control system, the licensee shall demonstrate that the computer and the access control system operate as planned:by 88 Y

4 1 attempting _to defeat the access control system in as many ways as possible. The computer must have suitable security features that prevent ~an irradia - a ter operator from commanding theicomputer to override the ace'... control system when it is required to be operable. Subpart 0 - Operation of Large Irradiators 'l j S 36.51 Training. (a) Btfore an individual is permitted to operate an irradiator-without a supervisor present, the individual must be instructed'in: j (1) The fundamentals of radiation protection applied to irradiators-l (including the differences between external radiation and radioactive con-tamination, units of radiation dose, NRC dose limits, why large radiation; doses must be avoided, how shielding and access controls prevent large doses, how an irradiator is designed to avoid contamination, the use of survey meters and personnel dosimeters, other radiation safety features of an irradiator, and the-basic function of the irradiator; j (2) The requirements of Parts 19 and 36 of NRC regulations;- (3) The operation of the irradiator; i (4) Licensee operating and emergency procedures that the individual i is responsible for performing; and [ (5) CasehistoriesofaccidNtsorproblemsinvolvingirradiators similar to those.to be used.by the individual. (b)~ Before an individual is permitted to operate an irradiator - l without a supervisor present, the. individual shall pass a written test on the instruction-received consisting primarily of questions based on the i licensee's operating and emergency = procedures. i 89 r

j (c) Before an individual is permitted to operate an irradiator without a supervisor present, the. individual, must have received on-the-job training in the use of the irradiator as described in the license applica-tion. The individual shall also demonstrate the ability to perform those portions of the operating and emergency-procedures that he-or she is to perform. (d) The licensee shall conduct safety reviews and emergency.' drills, as described below, for irradiator operators at. least annually; -The licensee shall give each operaton'.a brief-written test on the information. Each safety-review must include, to the extent appropriate, each of the' following-- (1) Changes in operating and emergency procedures since the last review, if any; (2) Changes in regulations and license con'ditions since the last review, if any; i (3)_ NRC reports on recent accidents, mistakes', or problems that'have occurred at irradiators, if any; (4) Relevant'results of inspections of operator safety per.formance; (5) Relevant results of the facility's operational. quality assurance s program; and l (6) A drill to practice an emergency or abnormal event procedure. (e) The. radiation safety officer or other management personnel shall. evaluate the. safety performance of each irradiator operator at.least annually to ensure that regulations, license conditions, and operating and emergency procedures are followed. ~The: licensee'shall discuss the results of. the evaluation with the operator, and shall instruct the operator on how to correct any mistakes or deficiencies' observed. 90 .. =.-.

~ l (f) Individuals who will be permitted unescorted access to the irradiator, but who have not received the training required for operators and the radiation safety officer, shall be trained and. tested in precau-tions they should take to avoid radiation exposure, procedures or parts j of procedures in S 36.53 that they are expected to perform or comply with, and their proper response to alarms required in this Part. Tests may be oral. (g) Individuals who must be prepared to respond to-alarms required by S 36.23(b), S 36.23(c), S 36.23(j), S 36.27(a), S 36.29(a), S 36.29(b), S 36.29(c), and S 36.33(d) shall be trained and tested on how to respond. Each' individual shall be retested at least once a year. Tests may be-oral. S 36.53 Operating and emergency procedures. (a) The licensee shall have and follow written operating procedures for-- (1) Operation of.the irradiator, including entering and-leaving the radiation room; -1 (2) Use of personnel dosimeters; (3) Surveying the shielding of panora.nic irradiators; (4) Monitoring pool water for contamination-while the water.-is in ] the pool and b; fore release of-pool wat'er to unrestricted areas; (5) Leak. testing of sources; (6) Operational inspection and' maintenance checks 1 required by-S 36.61; and '(7)- Loading, unloading, and repositioning sources, if the operations will be performed by the licensee. l 91 J

1 j (b) The licensee shall have and follow emergency or abnormaltevent procedures, appropriate for the Lirradiator. type, for-- (1) Sources stuck in the unshielded position; (2) Personnel overexposures; (3) A radiation alarm from.the product exit portal monitor or-pool' monitor; (4) Detection of leaking sources, pool contamination, or alarm caused by contamination of-pcol; water;- (5) A low water level alarm, an abnormal water loss,_ or leakage from th'e source storage pool; (6) A_ loss of electrical, power; (7) A fire alarm or explosion in the radiation room;' (8) An alarm indicating unauthorized entry into; radiation-room, area around pool, or another alarmed area; and (9) Natural phenomena, including.an earthquake, a tornado, flooding, or other phenomena as appropriate for.the geographical location ~of the

facility, 1

(c) The licensee may revise operating and emergency. procedures without Commission approval _only if all of the following conditions Ne met: I (1) The revisions do not reduce the safety of.the1 facility, (2) The revisions are consisi.ent with theLoutline or summary of l procedures submitted with thellicense application, (3) The revisions have been reviewed u d approved by the radiation safety officer, and (4) The users or operators are instructed and tested on the revised-procedures before they are put into use. 92

,g f 36.55 Personnel monitoring. I (a) Irradiator operators shall wear'either a film badge or a thermoluminescent dosimeter (TLD) while operating a' panoramic irradiator or while in the area around 1he pool of an underwater-irradiator. The film badge or TLD must be suitable for high energy photons in the normal and-accident dose ranges. Each film badge or TLD must be assigned to and worn by only one individual. Film badges must be replacsdiat.least monthly, and-TLDs must be replaced at'least quarterly. After replacement, each film badge or TLD must be promptly processed. (b) Other individuals who enter the radiation' room of'a panoramic-irradiator shall wear a dosimeter, which'may be a pocket' dosimeter. For-i . groups.of visitorc, only two people are required'to wear dosimeters. 6 36.57 Radiation surveys. (a) A radiation survey of the area outside the shielding of the radiation room of a panoramic-irradiator must be conducted with the sources' in the exposed position before the facility starts to operate. A radiation survey of the area above the pool of pool irradiators must be conducted i after the sources are loaded before the facility starts to operate. If the radiation levels specified in 9 36.25 are' exceeded, the' shielding must be repaired to comply with 'the Jose rate requiremeht ir. S 36.25 before operation of the fa-t. dy may start. (b) An additional radiation survey of the shielding-must be performed after new sources are loaded"and after any modifications that-might increase dose ra'.es are made to the radiation room shielding or._ structure. (c) Portable radiation survey meters used to meet the: requirements of paragraphs (a) and (b) of this section or the requirements.of f 36.37(c) 93 jj \\\\

i t-or 6 36.67(a) must be calibrated at least annually to an accuracy of t20 percent for the gamma energy of the sources in use.~ The~ calibration must be done at two points on each scale. f (d) Water from the irradiator pool or other potentially contaminated-liquids must be monitored for radioactive contamination before release to- ~ l unrestricted areas. Radioactive concentrations must not exceed those spec-ified in 10 CFR Part 20, Table II, Column 2 of Appendix B, " Concentrations in Air and Water above Natural: Background." The lower limit-of detection-l for the measurement must be below ti.ise concentrations. (e) Resins to be released-for re e,'eration or as nonradioactive waste v must be monitored before release-in an area.with a background. level less than 0.05 millirem (0.0005 millisievert) per hour. The resins may be' l released only if the survey does'not detect radiation levels above-back-ground radiation levels. The survey meter must be capable of detecting radiation-levels.of 0.05 millirem (0.0005-millisievert) per hour. S 36.59 Detection of leaking or contaminated sources. (a) The licensee shall assure that each sealed source received by the licensee after (effective date of rule) has been. tested for contamina-tion within the 6 months prior to being shipped to the licensee. l (b) Eech dry-source-storage sealed source must be tested for leak-age at intervals not to exceed 6 months using a leak test kit or method approved by the Commission or an Agreement State. The analysis must be capable of detecting the presence of 0.005 micro urie (185 becquerels) of radioactive material and must-be performed by a ptrson approved-by the-Commission or'an Agreement State to perform the analysis. (c). For pool irradiaurs, the pool water must be checked for contamination each day the irradiator operates. The check must be done by 94

,s - l using an online radiation monitor on a pool water circulating system as described in i 36.29-(b) or by analysis of pool water. (If a check for contamination is done by analysis of pool water, the results of the anal-ysis must be available within 24 hours. (d) If a leaking source is detected.. the licensee shall remove the leaking source from service and have it decontaminated, repaired, or. dis-posed of by an NRC or Agreement State licensee that is authorized to per-form these functions. The licensee shall promptly check its personnel, equipment, facilities, and irradiated product for radioactive contamina-tion. No product may be shipped until the contamination check has been done. If any personnel are contaminated, decontamination must be. pea-formed promptly. If contaminated equipment, facilities, or product ace-found, the licensee shall have them decontaminated or disposed of,by an NRC or Agreement State licens<e that is authorized to perform these func-j tions. If a pool is contaminated, the licensee shall; clean the pool until the contaminatica levels do not exceed the appropriate concentration in Table I, Column 2. Appendix B of Part 20. t I' S 36.61 Operational inspection and maintenance. (a) The licensee shall establish and implement an adequate opera-tional inspection and maintenance program as described in. license. application (i36.13(h)). This program shall include, as a minimum, inspecting or checking each of the follo%1ng aspects at the frequency specified in the license or license application:- ~(1) Operability of each aspect.of the access control system required by i 36.23. (2) Functioning of the source position indicator required by 636.31(b). 95 i-

1 tu -(3) Operability of the radiation monitor on the pool water purifi-cation system using a radiation check source if-this method'is' chosen to detect radioactive contamination in pool water ($ 36.29(b)),' (4) Pool conductivity _as required by l 36.63(a). (5) Operability of the product exit monitor required by 6 36.29. (6) Operability of the source return control required by 6 36.31(c). (7) Leak-tightness of tne pool = purification system (visual inspection). l (8) Operability of the heat and smoke detectors and extinguisher system required by 5 36.27. (9) Operability of the means of pool water replenishment required by-5 36.33(c). (10) Operability of the visible indicator of low pool ~ water level 1 required by 6 36,33(d). l (11) Operability of the intrusion alarm required'by 6 36.23(j), if applicable. l (12) Functioning and wear on the system, mechanisms,-and cab 1'es used to raise and lower sources. I (13) Condition of the barrier to prevent products from hitting'the-sources or source mecha'nism as. required by 6-36.35. (14) Amount of water added to.the pool'to_ determine if'the pool is. leaking. ~ (15) Electrical wiring on required safety systems for_ radiation-damage. (b) Malfunctions and defects found during operational inspection. and maintenance checks must be repaired without undue delay. l l 96 4 m I

s i, 1 $ 36.63 Pool water purity. (a) Pool water purification systems must be.run each day the irradiator operates and at least monthly during shutdowns. The purifica-tion system must continue running until:the conductivity of the pool' water drops below 10 microstemens per centime?ar. (b) The conductivity meter must be calibrated at least annually. S 36.65 Attendance during operation. (a) Both an operator :nd at least one other individual. trained and prepared to prc ptly render or summon assistance if the access control alarm sounds, shall be present on site whenever the irradiator is operated using an automatic product conseyor system. (b) At a panoramic irradistor at which static irradiations (no movement of the product) are b91ng performed,-a person who has received the operator training and testing described in $ 36.51(a) and (b) an'd the training on how to respond to alarms described in S 36.51(g) must be on site. (c) At an underwater irradiator, an operator must be present whenever product is moved into or ovt of the pool.- Static irradiations may be per-formed without a person present at theLfacility only if the personnel-access barrier around the puol is-locked to prevent unauth)tized entry and all required alarms are operable. 5 36.67 Entering and icaving the radiation room. J (a) Upon first entering the radiation room of a panoramic irradiator after an irradiation, the irradiator op3rator shalleuse a survey meter to s . cl

I determine that the source has returned to its fully shielded position.- The operator shall check the functioning of'the survey meter with a radia =

j tion check source' prior to entry.

I (b) Before exiting from and lacking-the door to the radiKion room of a panoramic frradiator prior to a planned irradiation, the irradiator operator shall: (1)visuallyinspecttheentireradiationroomto_ verify .l thatnooneelseisinitand(2)activatea~controlintheradiation room that permits the sources to be moved.from the shielded position only o if the door to the radiation room is locked within a' preset timeiafter setting the control. (c) During a power failure, the area around the pool of an underwater irradiator shall not be entered without using an operable and calibrated radiation survey meter. 9 36.69 Irradiation of explosive or highly flamable materials. (a) Irradiation of explosive material.is prohibited unless the licensee has received prior written authorization from the:Comission.. Authorization l l I will not be granted unless the licensee can demonstrate.in:the license application or application for amendment that detonation of:the explosive-would not rupture the sealed sources, injure-personnel, damage safety systems, or cause radiation overexposures of personnel. (b) Irradiation of more than traces of highly flamable material (flashpointbelow140*F)isprohibitedinpanoramicirradiatorsunless the licensee has received prior written authorization from the Comission.. Authorizationwill'notbegrantedunlessthelicenseecanhemonstrat'e'in the license application or application for amendment that a fire in the radiation room could be controlled without damage to se'aled sources or safety systems and without radiation'overexposures of personnel. 98

1 i e i, Subpart E Records and Reports a ! 3 1 0 6 36.81 Records and retention periods. l The licensee shall maintain.the following records at the irradiator for the periods specified. (a) A copy of the license application'and the license authorizing the licensee to operate the facility'unti14a new license.is, issued.. -(b) Records of an individual's training, tests, and safety reviews. providedtomeettherequirementsof536.51(a),(b),(c),(d),(f),and (g) until 3 years after the individual' terminates ' work. (c) Records of'the annual evaluations of the safety performance-of irradiator operators required by 1,36.51(e) for.3 years after the-evaluation. (d) An up-to-date copy l of the opera' ting and emergency procedures-required by 1 36.53.. Records of changes in procedures'as required by i 36.53(c)(3) retained for 3 years;from the!date of -the change. - (e) Film badge and TLD results required by 6.36.55 until the Commission terminates the license. ] (f) Records of radiation surveys required by i 36.57 for 3 years from the date of the survey. (g) Records of radiation survey. meter' calibrations required by i 36.57 until 3 years from the date of calibration. (h) Records of the results of leak tests required by I 36.59 for 3 years'from the date of the lekk test. (1) Records of. operational inspection and maintenance checks required by i 36.61 for 3 years. h 99

F , 1 ^ * - L (j). Records.of malfunctions, defects, operating difficulties or irregularities, and operating problems for'3 years after repairs are completed. l (k) An inventory of'all licensed sealed sources until the irradiator is decommissioned. The inventory-must include for each sealed source: the date received; the person from whom it was received; the'model of_the source; the serial number of the source, if.any;.the radionuclide.in the. source; the activity of the source as-supplied by the manufacturer; an.up-- to-date location of the source; information on leaking or-damaged sources and any. actions taken to decontaminate orl repair those sources; the date source was disposed of, if applicable;:and the person to'whom-the source was transferred, if applicable. (1) Records on the design checks required by S 36.39 and the construction control checks as required by.S 36.41 until the license is i l terminated. The. records must be signed and dated. The:titie ortqualifi-cation of the' person signing must be-included, (m) Records of water added to the pool as required by S 36.61(a)(14) I for three years. (n) Records related to decommissioning of the.irradiator as required by S 30.35(g). S 36.83 Reports. (a) The licensee shall report to the Commission -- (1) The theft or loss of radioactive material as: required by 10 CFR S 20.402; and (2) Events involving radioactive material possessed by the licensee that may have caused or threaten to cause radiation overexposures, exces-sive concentrations or levels of radiationi loss of~one day or more of 100 e e v --a w-se+, 4 --,4-y e .e- =

r operation of the facility, or property damage in excess of $2000~as required by 10 CFR $$ 20.403 or 20.405. (b) The licensee shall notify individuals of their exposure to= radiation or radioactive material as required by 10 CFR S 19.13. (c) The licensee shall report, in writing. leaking sources, damaged sources, and pool water contaminated in excess of the concentrations in Table 1, Column 2 of Appendix B to 10 CFR Part 20 to.the appropriate'NRC Regional Office listed.in Appendix 0 to Part 20 of this chapter within 5-days of discovering the contamination. _The report must describe.the; source involved if known, the extent of the. leakage or contamination, the cause or-circumstances leading to the leak or' contamination to the extent that they are known, and corrective actions taken up to the time-the report is made. (d) The licensee shall report within 5 days in writing to the appro-priate NRC Regional Office listed-in Appendix 0 of 10 CFR Part 20 the fol-lowing events if not reported under paragraphs (a) or-(c) of this section: (1) Sources stuck in an unshielded position. (2) Fire or explosion in a' radiation ~ room. (3) Damage to source racks. (4) Failure of the cable or drive mechanism used to move the source racks. (5)' Inoperability of the access control system. (6) Detection of radiation N the product exit portal monitor. (7) Abnormal or unusual radioactive contamination.- (8) Structural damage to the pool liner. or ' walls. (9)~ Abnormal water loss or leakage' from the source storage pool. (e) Reports must describe the event, what caused it (to the extent' -] known), and corrective actions to prevent recurrence.taken up to the time i the report is made.' i 101 1 i

= ,c .s 1 ] Subpart F - Enforcement t ,t S 36.91 Violations. (a) The Commission may obtain an injunction or other court' order to-prevent a violation of this'part.' (b) The Commission may obtain a court order for the pay.ient of a civil penalty imposed for violation of this part., (c) Any_ person who willfully violates any provision of this_part? issued underlsection 161b., i, or o.-of the Atomic Energy Act'of 1954', as amended, or the provisions-cited in the authority, citation-at.the beginning of this part may.be guilty of a crime and, upon conviction, be punished by fine or imprisonment, or both, as pro'vided by-law. ~ PART 19 - NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS;; INSPECTIONS-2. The authority citation for Part 19 continues to read,_in part,'as follows: ~ AUTHORITY:- Sec. 161,= Pub. L. 83-703, 68LStat.,948, as-amended-(42 U.S.C. 2201); Sec. 201, Pub. L.- 93-438, 88 Stat. 1242,.as amended (42 U.S.C. 5841)* * *. S 19.2 (Amended) 3. Section 19.2 is amended by changing "35" to_"36." S 19.3 [ Amended] 4. Section 19.3(d) is amended by changing 35" to "36"'in the first sentence. 102 l L

- r e.,, l i PART 20 - STANDARDS FOR PROTECTION AGAINST RADIATION l l 5. The authority citation for Part 20 continues to read in part, as follows: l AUTHORITY: Sec. 161, Pub. L. 83-703, 68 Stat. 948, as amended (42 U.S.C. 2201); sec. 201, Pub. L. 93-438, 88 Stat. 1242,.as amended (42 U.S.C. 5841)* * *; S 20.2 (Amended] 6. Section 20.2 is amended by changing "35" to "36." S 20.3 [ Amended] 7. Section 20.3(a)(9) is amended by changing "35" to "36." S 20.203 (Amended] 8. In S 20.203, paragraphs (c)(6) and (c)(7) are removed. PART 30 - RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL 9. The authority citation for Part 30 continues to read, in part, as follows: l AUTHORITY: Sec. 161, Pub. L. 83-703, 68 Stat. 948, as amended (42 U.S.C. 2201); Sec. 201, Pub. L. 93-438,_88 Stat. 1242 as amended (42 U.S.C. 5841)* * *. - 1 ~ \\ I 103 y e.

-.. ~ -. -.... y r, s-l- l: i30.4-[ Amended) 10. In i 30.4, the definition'of " License"..is~ amended by changing t "35" to "36." i' i 30.5 [ Amended)

11. Section 30.5'is amended by changing "35" to "36."

$ 30.6 [ Amended] 12. Ini30.6, paragraphs-(a)and;(b)(1)-areamendedbychanging"35" .I to "36." -f 5 30.11 [ Amended]

13. 'In i 30.11, paragraph'(a) is amended by changing "35";to "36."

l 30.13 [ Amended] l 14 Section'30.13 is amended by' changing "35" to "36". 6 30.14 [ Amended]' 15. In i 30.14, paragraph (a) is amended by changing:"35" to "36," andparagraph(c)isamendedbyadding",36"after"33,.l34".- l. I 30.15 [ Amended] i 16. In i 30.15, the introductory text of paragraph (a) is amended I by changing "35" to "36." i i l i.30.16 [ Amended]

17. Section 30.16 is amended by changing "35" to "36."

k 104

n ,,y 6 30.18 [ Amended) 18. In 6 30.18, paragraph (a).is amended by adding, "36" after "30 1 through 34." 1 5 30,19 [ Amended) 19. In S 30.13, paragraph (a) is amended by change."35" to "36.'" $ 30.20 [ Amended) 20. In 6 30.20, paragraph (a).is amended by. changing "35" to 36." 6 30.31 [ Amended) 21. Section 30,31 is amended by changing "35" to "36." t S 30.33 [ Amended) i 22. bection 30.33, paragraph (a)(4) is. amended by changing "35" to "36." I l 6 30.34 [ Amended) 23. Section 30.34, paragraphs (a) and (b) are amended by changing j "35" to "36"; paragraph (c) is amended by changing "35" to "36" in the first and the second sentences; paragraphs-(d) and (e) are amended by changing "35" to "36." a 5 30.39- [ Amended) 1 24. Section 30.39 is amended by changing "35" to "36." t 105 A 4 r ..m. .,.--w.,

j 3<r > I 30.51 (Amended) 25, In 6 30.51, paragraphs (a), (b), (c)(1),,and'(c)(2).are amended by changing "35" to "36." S 30.53- (Amended) q 26. The introductory text of 8 30.53 is amended by changing,"35" to "36." i PART 40 - DOMESTIC' LICENSING OF SOURCE MATERIAL 27. The authority; citation for,Part 40 contintes to read,. in part, as follows: AUTHORITY: Sec. 161, Pub.'L. 83-703, 68! Stat' 948',-as amended -(42 U.S.C. 2201);'Sec. 201,-Pub. L. 93-438,88 Stat. 1242:as-. amended. (42 U.S.C. 5841)* * *. S'40.5 (Amended]- 28. In 6 40.5, paragraph (h)(1) is' amended by changing <"35: to "36," in the first sentence. PART 51 - ENVIRONMENTAL REGULATIONS FOR DOMESTIC LICENSING AND. RELATED REGULATORY FUNCTIONS 29. The authority citation for:Part 51 continues to-read, in part,. l as follows: AUTHORITY: Sec. 161, 68 Stat. 948, as amended (42 U.S.C. 2201);' i Sec. 201 as amended, 202, 88 Stat. 1242, as amended.. 1244-(42 U.S.C. 5841, 5842). 106

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$ 51.22 (Amended) 30. e.n$51.22, paragraphs (c)(3),(c)(10)and(c)(14)areamended by adding "36," after "34, 35." 6 51.60 (Amended) 31. In S 51.60, paragraph (a) is amended by adding "36," after "34, 35." S 51.66 [ Amended) 1 32. ins 51.66, paragraph'(a)isamendedbyadding"36,"after"34', 35." S 51.68 [ Amended) 33. Section 51.68 is amerded by adding "36," after "34, 35,", PART 70 - DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL 34. The authority citation for Part 70. continues to-read, in part, as follows: AUTHORITY: Sec. 161, Pub. L.,83-703, 68 Stat. 948, as amended (42 U.S.C. 2201); sec. 201, Pub. L. 93-438,'88 Stat. 1242, as amended (42 U.S.C. 5841)*'* *. $ 70.5 -(Amended) 35. In S 70.5, paragraph (b)(1)'is' amended by changing "35" to."36." 107

a i f.>- S 70.20a. (Amended) j 36. In S 70.20a, paragraph /b) is amended.by. changing "3S" to."36." PART170-FEESFORFACILITIESANDMAT$RIALSLICENSFSANDOTHER-REGl'LATORY SERVICES UNDER THE ATOMIC ENERGY'ACT OF 1954,: AS AMENDED 37. The authority citation for Part 170 continues;to read, in part, as fol'ows: .UTHORITY: 31U.S.C.9701,-96 Stat.1051'LSec.30i,~ Pub.1 L.-. 92-314,: 86 Stat. 222 (42 U.S.C.- 2201w); sec. 201',_88 Stat; 1242, as amended (42 U.S.C. 5841)* * *. S 170.2 (Amended) 38. In S 170.2, paragraph (a)=is amended by changing "'.5" to:"36." I Dated at Washington, DC, this day of ./ tap , 1990.= l t F r the Nuclear Regulatory Commission. o-f G. u jamuel J..ChiU,N-i Eecretary 'of thp Commission. - '] -t t .i j ~108 _}}