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{{#Wiki_filter:..:U.S. NUCLEAR REGULATORY COMMISSION FebruarySREGULATORY GUIDEbOFFICE OF STANDARDS DEVELOPMENTREGULATORY GUIDE 10.7GUIDE FOR THE PREPARATION OF APPLICATIONS FOR LICENSESFOR LABORATORY USE OF SMALL QUANTITIES OFBYPRODUCT MATERIAL.19771. INTRODUCTIONThis..guide describes the type of informationneeded by the NRC staff t1 evaluate an application.. fforea specific license for laboratories using millicuriequantities of hbproduct material (reactor-producedradionuclides). This type of license is provided for..under Title 10. CodeofrFederalRegulations. Part 30.-Rules of General Applicability to Licensing ofByproduct Material.-S.Paragraph 20.1(c)-of 10 CFR Part 20. "Standardsfor Protection Against Radiation." states that"..persons engaaed in activities under licenses issued hythe Nuclear Regulatory Commission pursuant to theAtomic Energy Act of 1954. as amended, and the* .Energy. Reorganization Act of 1974 should. in addi-,ton tocomplying with the requirements set forth inthis part, make everv-reasonuhle effort to maintain..diation exposures. and rleases of radioactve.materials: n einlucLnts to unrestricted arcas.as-low as iis reasonabhl ahtcvahich" (A LAR_). Rcgu titatol3'SGude-8.10. " )Operating. Philosophv IrI Maintaining"Occupational Radiation Exposures AssLow As IsReasonabhh Achiev.,, provides thc*RC staffposition on thi. iamirta l1_subject. License applicantsshould g-, 0on;'. 60tion to the A LA RAphilos inWRegulatory Guide 8.10. inI v Fln tif 01ans for work with licensedra ct b~6uial'° 2. LICENSE FEESAn application 'fee. is required for most types oflicenses. The applicant should refer -to §170.31."Schedule of Fees.for Materials Licenses." of 10* "CFR Part 170 to determine the amountof fee thatmust accompany the application. Review of the ap-plication will not Iwgin ut, il the proper fee is receivedby the NRC.3. FILING AN APPLICATIONA licenew application for by product nmuterialshould he suhmitted tfi Form NRC 313* ",'Applica-lion for Byproduct Miaterial l.iLcnsC (%L ibe appeu-di\ to this guide). All items on the zpplicuaiib6 formshould he completed in sutTicicnt dotuil for thc NRCit) determine thatil fit uppikil ntls:"t'qUipllellt.facilities. and rai~oio~to reanare ade-qultte it) protect,ý, iL~lth Andrii~tsn~imi datnger to lifeand proprt'. "hc.h spce' provided on Form NRC-313 isirhmited1. applctant should append additionalto provide complete information. F:achse .paratc sheet or document subLtllted with the ap-plicalion should he identified by a heading indicatingthe appropriate item number (on Form NRC-313)and its purpose (e.g.. radiation safety instructions).The applica.tion should lie completed in triplicaite.The original and one copy should he mailed to:Radioisotope:, Licensing Branch. Division of FuelCvyec aod MIatertal Safety. Office of NuclearMaterial Safety and Safeltuards. U.S. NuclearRegulatory Commission. Washington. D.C. 20555.One copy of the application. with all attachments.should he retained by the applicant, since the licensewill require. as :t condition. that the institution follo-wthe stLtcmenits and representations set forth in the ap-plication and any stIpplememt to it.* Form N R C-13 Was foirmerly designated Form ALEC-313.Exisling copies or F:osrm AIEC.-313 m:A, still hb used.USNRC REGULATORY GUIDES CAI~~r .jui,uki Is W. wrt to It', 5m'routy tr ttv Ci.. t mswn.tUf tim.le iof,Rewlimka G...k .ri-w t..elf to dilcisLso ..fs.Ie -o,Ia.ble to the utisbtc flwtithods Ulm*, C ..... ...,%u-. Vd- nl M ....o. 1) C. O.d *i't.. .. o-airmmultle to low NRC sulst of mtIflenrq '.010.s Itan at 03l COMM3w' Woinch.tOt4t10 t*~1 flts. ,1t wt ý~t by It.I stif %WC11C Ifflibleeril I, I- ju .rt.3~ I .t3 ,,to Tam" ty o .0 .1ofrm olttui..~ Mac tilm , n, to ifrtle awato nirr t i tn 4ilic..so. Olovuliirey GutcirWit not ,ttu~itut.. l0r e.,wPsUIitM1. 'e not Ijo Vitth thnro 0, not feitu,111.. .Pr. ~~aqnf ~,tI.11.S the~s & t eC.1 w tuu- i d tfrm ,llanjlo w le t.1 .. Ihe qu .33 willto, AMIc. .1. ru-t.... P sI Itf-y ntso i.O55.I1C0t4tha'l at they ji or id ani WIWI It~e CaInv! ni ..jrlt in JIM stuoo~nn"u oat Smioriit .. 8. 0.,ro , Id) It -It0 C A mI W it u O f Id I I.. p J u t 4 fl .1 C ~ I O~ n 0i eWM ' t 4 , 0 .3 9 A i mlt, , 9 I l e .-e ivtt 4 3 s t;s9t .sj.g- yi .st. ,w te. i ,u4 ~ M 3 O*W rt.."c j.s",' It.s-~r ti !Jt. pltn3l3 5107M .t ,tn tt" t0 G4u eti t~Iott*.t..t 0Iitt* lit eltIc tree. stume";nt.k (SI ..3..'inero.. i thoerift ennsn)on t 00 eff, r if" ~ .own illatt.tc Urttt.sj it striitl tto l stt. t~.PItO.Im-1 infW i will lie 0th in 5' " *' Sit) 15 IJIC~tio etot "" I stnsosrn r sIt I. mq ..t M1 5i of I3~ mae Io-fsir, (uS. Ns.ts.I0,, l-itsltshoty .31 sI'sl s'y~.to f 5SQ~ t Sne s nfo In f .sit C .sl..tn. ..on"o on .i~gsd " nwWMr.wtrS, 0C 15s, tfl ti. f ttt' u ..t O il.50tit ii . CONTENTS OF AN APPLICATIONMost items of Form NRC-313 are sclf-explanator:(se instructions with the form). The following cornments apply to the indicated numbered items of th.form.hIem 1(a). Specify the applicant corporation oother legal entity by name and address of principaoffice. Individuals should be designated as the applicant only if the use of the byproduct material is noconnected with the individual's employment withcorporation or other entity. If the applicant is an individual, the individual should be specified by fulname and address, including state and zip code.hem 1(h). Specify the street address of the locatiorof use if the address differs from the one given in itcrrI(a). If use is to be at more than one location. thispecific address of each should be given. Describe thiextent of use and the facilities and equipment at eacalocation. A post office box address is not acceptableItem 4. Specify the names of the persons who wildirectly supervise the use of radioactive material oiwho will use radioactive material without supervi.sion.hem 5. Specify the name of the person who will htdesignated as the radiation protection officer.* Thisperson should be responsible for implementing th(radiation safety program and therefore readilyavailable to the users in case of difficulty and shouldbe trained and experienced in radiation protectiorand in the use and handling of radioactive materials.Ite't 6(a i amdl 1b. Describe the byproduct rnatcriaby isotope, chemical and/or physical form. and ac.tivity. in millicuries or microcurics. A separate pos.session limit for each nuclide should be specifiedPossession limits requested should cover the total an.ticipated inventory, including stored materials andwaste. and should be commensurate with the appli-cant's needs and facilities for safe handling.If the use of sealed or plated sources is con-templated, the isotope. manufacturer, and modelnumber of each sealed or plated source should beIf a source will be used in a gaschromatograph, gauge, or other device. the manufac-turer and model number of the device should bespecified.Item 7. The use to be made of the radioactivematerials should be clearly described. Sufficientdetail should be given to allow a determination of thepotential for exposure to radiation and radioactivematerials of both those working with the materialsand the public,*The terms "radiation protection officer" and-radiological safety officer" are synonymous.items 8 and 9. A resume of the training and ex-perience of each person who will directly supervisey the use of material, who will use material without-supervision, or who will have responsibilities forc radiological safety should be submitted. The resumeshould include the type (on-the-job or formal coursework), location, and duration of the training. Train-r ing should cover(1) principles and practices ofradia-I tion protection: (2) radioactivity measurements," standardization, and monitoring techniques and in-t struments, (3) mathematics and calculations basic tothe use and measurement of radioactivity, and (4)-biological effects of radiation. The description of theI use of radioactive materials should include thespecific isotopes handled, the maximum quantities ofmaterials handled, where the experience was gained,n the duration of experience, and the type of use. Thequalifications, training, and experience of eachperson should be commensurate with the materiale and its use as proposed in the application. Theamount and type of training and experience withradiation and radioactive materials required to sup-port a determination of adequacy by the Commissioni will vary markedly with certain factors.The use of microcurie quantities of a few non-volatile radioactive materials by a person with ae minimum of training and expcrience under preciselyspecified and carefully controlled conditions subjectto the surveillance of a competent and adequatelyy trained radiation protection officer may be justified.I Such minimum training and experience may consistof a few hours of training and experience in the use ofone or more radioactive materials similar to the useproposed in the application under the supervisionI and tutorship of a licensed user.Persons using miillicurie quantities of a number ofradionuclides for general laboratory tracer work un-der unspecified condition should have more exten-sive training and experier.ce and, depending on theexact nature of the proposed program or use ofradionuclides, may need to have completed formal-course work at the college or university level coveringthe areas listed under Item 8 of Form NRC-313.The use of larger quantities of material (ap-proaching a curie) under conditions where a potentialexists for significant loss and ingestion, inhalation, orabsorption of the radioactive material by those work.ing with the material is normally done under carefullycontrolled conditions using specialized equipment. Aperson who is to use radioactive materials inde.pendently under these conditions should not onlyhave a background of formal training in all areas ofItem 8 of Form NRC-313 but should also have exten.sive experience working with radioactive materialand a thorough working knowledge of the equipmentrequired to handle the material safely.10.7-2I l Items 10 and II. Specify for each radiation detec-tion instrument the manufacturer's name and modelnumber, the number of each type of instrumentavailable, the type of radiation detected (alpha. beta.or gamma), the sensitivity range (milliroentgens perhour or counts per minute), the window thickness inmg/cm2.and the type of use. The type of use wouldnormally be monitoring, surveying, assaying, ormeasuring.Describe the instrument calibration procedure.State the frequency. and describe the methods andprocedures for the calibration of survey and monitor-ing instruments, as well as any other instruments andsystems used in the radiation protection program.such as measuring instruments used to assay scaled-source leak-test samples (see Item 14). contaminationsamples (e.g., air samples, surface "wipe' samples).and bioassay samples (see Item 12).An adequate calibration of survey instrumentsusually cannot be performed with built-in checksources. Electronic calibrations that do not involve asource of radiation arc also not adequate to deter-mine the proper functioning and response of all com-ponents of an instrument.Daily or other frequent checks of survey instru-ments should be supplemented every 6 months with atwo.point calibration on each scale of each instru-ment with the two points separated by at least 50% ofthe scale. Survey instruments should also becalibrated following repair. A survey instrument maybe considered properly calibrated when the instru-ment readings are within +/-10 percent of thecalculated or known values for each point checked.Readings within- +/-20 percent are considered accep-table if a calibration chart or graph is prepared andattached to the instrument.If the applicant proposes to calibrate his survey in-struments, a detailed description of planned calibra-tion procedures should be submitted. The descriptionof calibration procedures should include, as aminimum:a. The manufacturer and model number of eachradiation source to be used.b. The nuclide and quantity of radioactivematerial contained in each source,c. The accuracy of the source(s). The traceabilityof the source to a primary standard should beprovided.d. The step-by-step procedures, including as-sociated radiation safety procedures, ande. The name and pertinent experience of eachperson who will perform the calibrations.If the applicant intends to contract out the calibra-tion of instruments, the name, address, and licensenumher of the Firm should be specified together %% iththe frequency of calibration. The applicant shouldcontact the firm that "rill perform the calibration. todetermine if information concerning calibrationprocedures has been filed with the Commission. Ifinformation concerning calibration procedures hasnot been filed, it should be obtained and submitted.Quantitative measuring instruments used tomonitor the adequacy of containment and con-tamination control such as those used for measuringleak test. air. effluent. bioassay, suork area. andcquipnient contamination samples should usually hecalibrated prior to each use. The procedures and fre-quency for calibration of such instruments should hesubmitted and should include:a. The name of the manufacturer and modelnumber of each of the standards to he used.h. The nuclide and quanity of radioactiVcmaterial contained in each of the standard sources.c. A statement orthe accuracy of each of the stan-dard sources. The source accuracy should be. as aminimum. +/- 5 percent of the stated value andtraceable to a primary standard, such as that main-tained by the National Bureau of Standards.d. Step-by-step calibration procedures and. if ap-propriate. associated radiation safety procedures.ande. The name and pertinent experience of eachperson who will perform the instrument calibrations.hem 12. Personnel monitoring is required if aperson is likely to receive in a calendar quarter 313millirems to the body. 4.69 rems to the estremities. or1.88 reins to the skin (lowcr limits apply to those un-der 18 years of age: see ,20.101 and 20.202 of 10CFR Part 20). Personnel monitoring is also requiredif a person enters a high radiation area (greater than100 millirems per hour). If personnel monitoringequipment will be used. the name of the organizationfurnishing film badge or thermoluminescentdosimeter (TLD) service and the frequency forchanging badges, dosimeters. etc.. should bespecified. If pQcket chambers or pocket dosimeterswill be used, the useful range of the device, in mil-liroentgens. the frequency of reading, and theprocedures for maintaining and calibrating thedevices should be specified.If personnel monitoring will not be used, the appli-cant should submit calculations or documentationfrom radiation surveys that demonstrate that it is un-likely that any individual will receive a dose equal toor greater than that indicated in the precedingparagraph.The applicant should show that the need for bioas-says has been thoroughly considered and should es-tablish the adequacy of the proposed hioassayS010.7-3 Iprogram in relation to the proposed program of useof radioactive material. Bioassays are normally re-quired when individuals work with millicurie 4uun-tities of hydrogen-3. iodine-125. or iodinc-131depending on the type of work, equipment, andpiocedures followed. Other materials man also beused in physical or chemical forms and under condi-tions that present an opportunity for uptake by thebody through ingestion. inhalation, or absorption. Abioassay program to determine and control the up-take of radioactive material should be considered anddiscussed in relation to cach such material.procedure. etc. Regulatory Guide 8.9. "AcceptableConcepts. Models. Equations. and Assumptions for aBioassay Program."' may be consulted.The criteria to he used in determining the need forbioassays, the type and frequency of bioassays thatwill he performed, and the bioassay proceduresshould be specified and described in detail. If a com-mercial bioassav service is to be used, the name andaddress of the firm should be provided.ilioassaf.s may not he substituted for other cle-ments of a safety program such as air monitoring anddispersion control (hoods. glove boxes. etc.) and for%tell-thought-out and ssell-cxecuted handlingprocedures.liem 13. The equipment and facilities for each siteof use should be described in detail. The proposedequipment and facilities for each operation to be con-ducted should he adequate to protect health andminimize danger to life and property. In describingavailable equipment and facilities, the following typesot information should be included, as appropriate:a. Physical plant. laboratory, or working areafacilities. Fume hoods, glove boxes, waste recep.taces, special sinks, ventilation and containmentsystems, effluent filter systems, and all processing,work. and protective clothing change areas should bedescribed.b. Containers. devices. protective clothing, aux-iliary shielding, general laboratory equipment, airsampling equipment, etc., actually employed in thedaily use of material. Special provisions for shieldingand containment to minimize personnel exposureshould be described.c. Storage containers and facilities. These shouldprovide both shielding and security for materials.d. The number, type. and length of remote handl-ing devices.* A copy of this guide may he obtained by a written requestto the U.S. Nuclear Rcgulatory Commission. Washington.D).C. 20555., Attention: Director. Office of StandardsDevelopment.lIent 14.a. Survey Program. Commission regulations re-quire that surveys be made to determine if radiationhazards exist in a facility in which radioactivematerials are used or stored (see §20.201. 10 CFRPart 20). A survey should include the evaluation ofexternal exposure to personnel, concentrations of air-borne radioactive material in the facility, andradioactive effluents from the facility. Although atheoretical calculation is often used to demonstratecompliance with regulations regarding airborne orexternal radiation, it cannot always be used in lieu ofa physical survey.Except for those cases where sources of radiationand radioactive material are well known and ac-curately and precisely controlled. it will usually benecessary that a physical survey be made with ap-propriate detection and measurement instruments todetermine the nature and extent of radiation andradioactis material or, as a minimum, confirm theresults of a theoretical determination.A radiation protection program should include thefollowing surveys for radioactive contamination andradiation:(I) In laboratory areas (e.g., checking for con-tamnination on bench tops, handling and storageequipment, clothing, hands, etc.).(2) Whilc work is being done with radiation orradioactivc materials (e.g.. breathing zone air sur-veys: general air surveys; personnel exposuremeasurements, including eyes and extremities: check-ing shutters and containment. etc.).(3) In areas associated with disposal or releaseof radioactive materials (e.g., checking disposal con-tainers and disposal sites: liquid, gas, and solid ef-fluents: filters and filter-duct systems: etc.).The frequency of surveys will depend on the natureof the radioactive materials and their use. However.surveys should be performed prior to the use ofradioactive materials in order to establish a baseline.The surveys should be repeated when radioactivematerials arc present, when the quantity of materialpresent changes, or when changes occur in their con-tainment systems or methods of use. Repetitive sur-veys may also be necessary to control the location ofradioactive materials in the handling system and intic case of the use of sealed sources outside a shieldedcontainer.For operations involving materials in gas, liquid,or finely divided forms, the survey program should bedesigned to monitor the adequacy of containmentand control of the materials involved. The programshould include air sampling, monitoring of effluents,010.7-4 and surveys to evaluate contamination of personnel,facilities, and equipment.The description of an air sampling program shouldinclude the area where samples will be taken, the fre-quency of sampling, and the location of the samplerwith respect to workers' breathing zones. Assays per-formed to evaluate air samples and the methods usedto relate results to actual personnel exposures shouldalso be described.The effluent monitoring program for releases tounrestricted areas should encompass all airborne andliquid radioactive material releases. Theoreticalevaluations should be suppLmcnted by stackmonitoring, water sampling, and nther environmen-tal monitoring appropriate for thc planned andpotential releases.For operations involving only sealed sources, asurvey program should include evaluation and/ormeasurement of radiation levels for storage and useconfigurations. When sources are used in deviceshaving "on" and "ofr' positions. both positionsshould be evaluated at the time of installation. Sup-plemental surveys should be performed following anychanges in operation, shielding, or use.The types. methods. and frequency of surveysshould be specified. Guidance may be obtained fromthe National Council on Radiation ProtectionReport No. 10. "Radiological Monitoring Methodsand Instruments,*' and the International AtomicEnergy Agency's Technical Rcport Series No. 120."Monitoring of Radioactive Contamination on Sur-faces."*b. Records Management Program. Provision forkeeping and revicwing records of surveys: materialsinventories: per'sonnel exposures; receipt. use. anddisposal of materials. etc.. should be described.Persons responsible for keeping and reviewingrecords should be identified.c. Emergency Procedures. The applicant shouldsubmit written emergency procedures for-employeesin case of spills. fires, release or loss of material, oraccidental contamination of personnel, includingdecontamination procedures and the names ofpersons who arc to be notified in an emergency.d. Sealed-Source Leak-Test Procedures. Sealedsources containing more than 100 microcuries of abeta or gamma emitter or more than 10 microcuriesof an alpha emitter must be leak tested at 6-month in-tervals. Leak testing of alpha-particle-emittingsources containing more than 10 microcuries of an*Copies may be obtained from NCRP Publications, P.O.Box 4867. Washington. D.C. 20008.69Copies may be obtained from UNIPUB. Inc.. P.O. Box433. New York. N.Y. 10016.alpha emitter is rcqliired at 3-month intervals. If acommercial firm is to perform the Irak tests, thename. address. and license number of the firm shouldhe submitted, If the tests arc to be performed using acommercial "kit." the name of the kit manufactureror distributor and the kit model designation shouldbe given. If the applicant intends to p.rform his ou nleak tests without the use of a commercial kit, the fol.lowing information should be submitted:I) Qualifications of personnel who will performthe leak test.(2) Procedures and materials to be used in tak-ing test samples.(3) The type manufacturer's name. modelnumber, and r;4iajiin detection and measurementcharacteristics o the'nstrument to be used for assayof test samples.(4) lnstruwment calibration procedures., includingcalibration source characteristics. make. and modelnumber, and(5) The method, including a sample calculation.to be used to convert instrument readings to units ofactivity. e.g.. microcurics.hctm 15. The procedures for disposing ofbyproduct material waste should be described. UnderNRC regulations, a licensee may dispose of waste inthe following ways:a. Transfer to a person properly licensed to receivesuch waste in conformance with paragraph 20.301(a)of 10 CFR Part 20. The name of the firm (whichshould be contacted in advance to determine an%limitations that the firm may have on acceptance ofwaste) should be given.b. Release into a sanitary sewer in conformancewith §20.303 of 10 CFR P:trt 20. Depending on waterusage. releases of up to I curie per year are permitted.c. Burial in soil in conformance with §20.304 of 10CFR Part 20. Up to 12 burials per year are permissi-ble. The allowable quantity depends upon theradionuclide.d. Release into air or water in concentrations inconformance with §20.106 of 10 CFR Part 20. Possi-ble exposure to persons offsite limits the amount thatmay he released.e. Treatment or disposal by incineration in confor-mance with §20.305 of 10 CFR Part 20. This must bespecifically approved by the Commission.f. Other methods specifically approved by theCommission pursuant to §20.302 of 10 CFR Part 20.E010.7-5 5. AMENDMENTS TO LICENSESS. RENEWAL OF A LICENSELicensees are required to conduct their programsin accordance with statements, representations, andprocedures contained in the license application andsupportive documents. The license must therefore beamended if the licensee plans to make any changes infacilities, equipment (including monitoring and sur-vey instruments), procedures, personnel, orbyproduct material to be used.Applications for license amendments may be filedeith.r w. the application form or in letter form. Theapplication should identify the license by number andshould clearly describe the exact nature of thechanges, additions, or deletions. References topreviously submitted information and documentsshould be clear and specific and should identify thepertinent information by date, page. and paragraph.An application for renewal of a license should befiled at least 30 days prior to the expiration date. Thiswill ensure that the license does not expire until finalaction on the application has been taken by the NRCas provided for in paragraph 30.37(b) of 10 CFR Part30.Renewal applications should be filed on FormNRC-313, appropriately supplemented, and shouldcontain complete and up-to-date information aboutthe applicant's current program.In order to facilitate the review process, the ap-plication for renewal should be submitted withoutreference to previously submitted documents and in-formation. If such references cannot be avoided. theyshould be clear and specific and should identify thepertinent information by date, page, and paragraph.S00I10.7-6 OAPPENDIXForm AIC-313 UNITED STATES ATOMC eNerGY COCMISSION10 CIA 30 APPLICATION FOR BYPRODUCT MATERIAL LICENSE 'e"" " oUSSTRUCT"OF4S.-Complate Horns 1 through 16 if this Is an iritiil applic4alon of an application for henewal of a license. Informiaton contaled an r.vius applicatlOnls (dd with the CommItf4ah n with respect to Items 0 through 15 mey be incoporlteo by reflerence promded rterences at# ci.so andispiochc. Use supplemental shoets whire nTcussaty. Item 15 must be completed on all Maii two copies Wo U S Atomic Energy Comms-ioa. Washington. D.C.. 20545, Attention: Matiials Branch. Direclorate of ULcensing. upon approval of this application. the applicaml win an AECByproduct Material Lcn"s. An AEC Byproduct Material Uclnts Is Issued In accordance with the general requirements contained in Tnl 10. Code of Fed-ratl Flegulation. Pail 30, and the Is subject to Title 10, Code of Federal Rgplatioti4. Pan 20. and the ft ptovisions ot Tifle 10. Code ofFederal Regulations, PaiR 170. The license fee cateqory should be staled in Haem 16 and the appropriate lee enclosed. (See Nloe in Instrueloen sheoel1. (a) kAME AND STRET AlOMlSS OF APPIUCANT. (htitutftbi. Iran. tiloagH per. 11.1 StWall ADD* SSIISI AT WHiiCa 57P500UCI .AIIIIAt WJLl U LJ*IO sifSoo. 0rC baciw* D Code mod blofphof. nvmber1 I &Wsitk... 11. &via.%ZFCO. I2. DIPAX1XINI TO UISE itSOUOV kAUTINIAt3. PRIVIOtJI SIINIL MUMMIES[$) fit ika'a m. pM Vo P..af k~~isi ~~phm.; -daf aid 9-. ý IS4. INDIVIDUAL US~IRIS. (Naue O~d irffet Of..dsia --it iii -itwriy 5 IAW'ONA)A Pa"tC"0#N O#I1CAR (P of pim d*..p..dm a. a.0- pýu1w O. jOoe 0c W.-AMI5. -A~anw 'a-o o A.. tm.- ami "pi"__ ~ ~ ~ ~ ~ ~ ~ ~ a A4 bp~ds I C..rogo*Eu ei5d 9.1e. (1) WTPOVUCT MAT11RIAL.' it sewwwa lb) OUMICAL AND/Oft PKTSICAL FO"M ANP MAAVMUM NUM29S Or s~AQUICL111 Of 1ACM C~iLMiCAL ANDOS1 011M"-Winm -1d. *F00,11kJ 'CAL 0M hAiTYOP.)WniPOSMSSA At AN PT OEns araae oarll ia I ~ edo Oakba... u~ifb.W. f6OWW an W mo -.- Oti-o Pat- SO7. 592S PW5l PMW1KCN ITODUCT MAlKUA WILL MUED lxi i 7m n.W .M A .p5Mue A FioeAliC.31J i4 A? a. owsis li.en *I " t. If 6wied" -is in go him of, a weld am. 6KAi6 Ow ..c ed &.d. aw" oiiwv at' "S iOwua toogewin opifa ds..s Mi. EA ftev #ow -he dftfd end/ar usd1l.0lCemlieafed on nriesin side)310.7-7 1RAINING AND EXPERIENCI: OF EACH INDIVIDUAL NAMED IN ItEM 4 evi..I.nnO AesI ..e'I ____* TYPE OF TRAININGa 1"..P0 o:j p tfcs Fyes Ida Yes Nolo5d~oact..lp -tt,@* sandacfS.d:a o 1. NIQ '. a-''il -o'do- SO40oI'.O' oI o, Ys No Yet NoI .an Aluho ob s cmd .n C090 Pfn bo~ oce$- _______0_____ t...-.yet--No-.V.s NO8 .bi* o and~ of | {{#Wiki_filter:..:U.S. NUCLEAR REGULATORY COMMISSION FebruarySREGULATORY GUIDEbOFFICE OF STANDARDS DEVELOPMENTREGULATORY GUIDE 10.7GUIDE FOR THE PREPARATION OF APPLICATIONS FOR LICENSESFOR LABORATORY USE OF SMALL QUANTITIES OFBYPRODUCT MATERIAL.19771. INTRODUCTIONThis..guide describes the type of informationneeded by the NRC staff t1 evaluate an application.. fforea specific license for laboratories using millicuriequantities of hbproduct material (reactor-producedradionuclides). This type of license is provided for..under Title 10. CodeofrFederalRegulations. Part 30.-Rules of General Applicability to Licensing ofByproduct Material.-S.Paragraph 20.1(c)-of 10 CFR Part 20. "Standardsfor Protection Against Radiation." states that"..persons engaaed in activities under licenses issued hythe Nuclear Regulatory Commission pursuant to theAtomic Energy Act of 1954. as amended, and the* .Energy. Reorganization Act of 1974 should. in addi-,ton tocomplying with the requirements set forth inthis part, make everv-reasonuhle effort to maintain..diation exposures. and rleases of radioactve.materials: n einlucLnts to unrestricted arcas.as-low as iis reasonabhl ahtcvahich" (A LAR_). Rcgu titatol3'SGude-8.10. " )Operating. Philosophv IrI Maintaining"Occupational Radiation Exposures AssLow As IsReasonabhh Achiev.,, provides thc*RC staffposition on thi. iamirta l1_subject. License applicantsshould g-, 0on;'. 60tion to the A LA RAphilos inWRegulatory Guide 8.10. inI v Fln tif 01ans for work with licensedra ct b~6uial'° 2. LICENSE FEESAn application 'fee. is required for most types oflicenses. The applicant should refer -to §170.31."Schedule of Fees.for Materials Licenses." of 10* "CFR Part 170 to determine the amountof fee thatmust accompany the application. Review of the ap-plication will not Iwgin ut, il the proper fee is receivedby the NRC.3. FILING AN APPLICATIONA licenew application for by product nmuterialshould he suhmitted tfi Form NRC 313* ",'Applica-lion for Byproduct Miaterial l.iLcnsC (%L ibe appeu-di\ to this guide). All items on the zpplicuaiib6 formshould he completed in sutTicicnt dotuil for thc NRCit) determine thatil fit uppikil ntls:"t'qUipllellt.facilities. and rai~oio~to reanare ade-qultte it) protect,ý, iL~lth Andrii~tsn~imi datnger to lifeand proprt'. "hc.h spce' provided on Form NRC-313 isirhmited1. applctant should append additionalto provide complete information. F:achse .paratc sheet or document subLtllted with the ap-plicalion should he identified by a heading indicatingthe appropriate item number (on Form NRC-313)and its purpose (e.g.. radiation safety instructions).The applica.tion should lie completed in triplicaite.The original and one copy should he mailed to:Radioisotope:, Licensing Branch. Division of FuelCvyec aod MIatertal Safety. Office of NuclearMaterial Safety and Safeltuards. U.S. NuclearRegulatory Commission. Washington. D.C. 20555.One copy of the application. with all attachments.should he retained by the applicant, since the licensewill require. as :t condition. that the institution follo-wthe stLtcmenits and representations set forth in the ap-plication and any stIpplememt to it.* Form N R C-13 Was foirmerly designated Form ALEC-313.Exisling copies or F:osrm AIEC.-313 m:A, still hb used.USNRC REGULATORY GUIDES CAI~~r .jui,uki Is W. wrt to It', 5m'routy tr ttv Ci.. t mswn.tUf tim.le iof,Rewlimka G...k .ri-w t..elf to dilcisLso ..fs.Ie -o,Ia.ble to the utisbtc flwtithods Ulm*, C ..... ...,%u-. Vd- nl M ....o. 1) C. O.d *i't.. .. o-airmmultle to low NRC sulst of mtIflenrq '.010.s Itan at 03l COMM3w' Woinch.tOt4t10 t*~1 flts. ,1t wt ý~t by It.I stif %WC11C Ifflibleeril I, I- ju .rt.3~ I .t3 ,,to Tam" ty o .0 .1ofrm olttui..~ Mac tilm , n, to ifrtle awato nirr t i tn 4ilic..so. Olovuliirey GutcirWit not ,ttu~itut.. l0r e.,wPsUIitM1. 'e not Ijo Vitth thnro 0, not feitu,111.. .Pr. ~~aqnf ~,tI.11.S the~s & t eC.1 w tuu- i d tfrm ,llanjlo w le t.1 .. Ihe qu .33 willto, AMIc. .1. ru-t.... P sI Itf-y ntso i.O55.I1C0t4tha'l at they ji or id ani WIWI It~e CaInv! ni ..jrlt in JIM stuoo~nn"u oat Smioriit .. 8. 0.,ro , Id) It -It0 C A mI W it u O f Id I I.. p J u t 4 fl .1 C ~ I O~ n 0i eWM ' t 4 , 0 .3 9 A i mlt, , 9 I l e .-e ivtt 4 3 s t;s9t .sj.g- yi .st. ,w te. i ,u4 ~ M 3 O*W rt.."c j.s",' It.s-~r ti !Jt. pltn3l3 5107M .t ,tn tt" t0 G4u eti t~Iott*.t..t 0Iitt* lit eltIc tree. stume";nt.k (SI ..3..'inero.. i thoerift ennsn)on t 00 eff, r if" ~ .own illatt.tc Urttt.sj it striitl tto l stt. t~.PItO.Im-1 infW i will lie 0th in 5' " *' Sit) 15 IJIC~tio etot "" I stnsosrn r sIt I. mq ..t M1 5i of I3~ mae Io-fsir, (uS. Ns.ts.I0,, l-itsltshoty .31 sI'sl s'y~.to f 5SQ~ t Sne s nfo In f .sit C .sl..tn. ..on"o on .i~gsd " nwWMr.wtrS, 0C 15s, tfl ti. f ttt' u ..t O il.50tit ii s.0 | ||
* ad -000-0 y es NoYe9 (IIIIIIENCI WIT" 11AOIATION fA,*.~aI wo. of 'ada -1aapes of*..'~$*p.4'Sot0o' ..jU AOJi ."let trot-SINci WAS rAINID DUIAIO Al ots 001PIIIINCI ITYP OP ust10 kADIAftON (ITICTION INSTRUMENIS r~it woo1nronamo skeelt .4 notospo, IFIlE of INSIIUMINI5 U II -.DAT -(. S --'at I ý O KINUISS1SA-IT.O Uýdi~t -d.?1 TWINOO II Dilib..,~~~~~~~~~~~~~~~~~~~~c 1. d.0'Dbo i~ VAIStIDT~I I j 9* ~ ~ eng ~~~ .gI I M"flOO. PRIOV(PE.CV. A-4 SIANDANDS USED IN CALISILAIIINC, INSTIUPAIMIS LISTED ASIDVI42 U.MLADES.OOSM!TSI.AND 110 ASSAY PROCIDUIIt USED (P I ade. wseo:4P 'n*Aod of tot-beaoa 00of 5~CI aoi-. 4w -0.0 of s.aJpohINFOPLAATFON TO S1 SUBMITTED ON ADDITIONAL SHIRTS IN DUPLICATE13 FACIIIII AND EQUIPMENT Desc-b. Iebaoatwy let1,hmeo end m-Moh he-dllsg stlyp~ei. stwage cemo'a j. 1%...Id--, P..-O Noojs, sto: 1.010,4a'.. iA.NI.4 116olo .0 ovoothe pCa,4. ao"sl yet No14 NADIATION P1OTICTION FI0155AM Dssw.,be Ike a0.4466A P-eetheft OKOI-w- dtcWdg CO-9101 ..eaiQ,.i 10 *gpIoqQ40e to... stated .o.e .~b.,q I"%L1811.1. p*d..'e .e apoI,4bI.. nOG.. 04-~q, aend espe,,.#.e of pesonb to peio,voos Loot Wie4. 0. ..nndn,1 o'an ,A.,0-0 fad-011" W-09.,,.0-2. and~~t 0. 19po., 94 1%* tw-to,*I I WASTE DolSPO141 I ag commudsng. erete d-iflesal get-te sI eeilaygod. gpoilPy oeos of tolosopon. 01onso.$S~. febll,t de'a.1*4 dec.pI 4 -sA ..4.4k .jIbe .sod #a, dopooo-o of sod-oath*. -01111 and ash-Wet., I%#0 hPe and ....otl of O(.socino.o1 Inelod,CERTIFICATE (This Item must be completed by applicant)40 11`11 APPLICANT1 AND ANY OFFICIAL. EXECUTING 18441 C1IITIPICAll ON SItHA Of T111 APPIICAMT NAMED IN ITEMA 1. CERTIFY THAT 1THIS AMIIC.A1TON ISPIEP4210 IN CONIFOMITY WT1H ?MEs 10. Cool Of FDERAL IIGULAT)Ok$. PAl? 30. AID tHAI Att4 INPOIM.ATION CONTAINED '4151484. iNCLuviNo ANYSUPPIsotMINT ATTACIOID MINE1O. IS TRnUE AND0 cosIXEC TO TE1)111 OFl OPI Out KNOWSIO AND MIItWcAna. foe CeI0o'ga~yS___________F" (nfim.ed IApp4.cae sma-W o 4. 1by;Tal u cvnfyinq .AcilSDocteWAINIO.-ISI U. S. C.. $oeehen 100 1 Ali of Joao 25. 194 81 62 Stag. 749; mvaligi t a5 uuiskinal offeftse go MO%0 a *itlfvllrfa 4,1,. loafenI orfOMAtM11 SO 4pep AA dee lotle 094onty Of IhO Unsled Slates Iast any wallet -ithin ift mos.d,efieam.61.15.11-P100 1973-043.126/21010.7-s}} | 4. CONTENTS OF AN APPLICATIONMost items of Form NRC-313 are sclf-explanator:(se instructions with the form). The following cornments apply to the indicated numbered items of th.form.hIem 1(a). Specify the applicant corporation oother legal entity by name and address of principaoffice. Individuals should be designated as the applicant only if the use of the byproduct material is noconnected with the individual's employment withcorporation or other entity. If the applicant is an individual, the individual should be specified by fulname and address, including state and zip code.hem 1(h). Specify the street address of the locatiorof use if the address differs from the one given in itcrrI(a). If use is to be at more than one location. thispecific address of each should be given. Describe thiextent of use and the facilities and equipment at eacalocation. A post office box address is not acceptableItem 4. Specify the names of the persons who wildirectly supervise the use of radioactive material oiwho will use radioactive material without supervi.sion.hem 5. Specify the name of the person who will htdesignated as the radiation protection officer.* Thisperson should be responsible for implementing th(radiation safety program and therefore readilyavailable to the users in case of difficulty and shouldbe trained and experienced in radiation protectiorand in the use and handling of radioactive materials.Ite't 6(a i amdl 1b. Describe the byproduct rnatcriaby isotope, chemical and/or physical form. and ac.tivity. in millicuries or microcurics. A separate pos.session limit for each nuclide should be specifiedPossession limits requested should cover the total an.ticipated inventory, including stored materials andwaste. and should be commensurate with the appli-cant's needs and facilities for safe handling.If the use of sealed or plated sources is con-templated, the isotope. manufacturer, and modelnumber of each sealed or plated source should beIf a source will be used in a gaschromatograph, gauge, or other device. the manufac-turer and model number of the device should bespecified.Item 7. The use to be made of the radioactivematerials should be clearly described. Sufficientdetail should be given to allow a determination of thepotential for exposure to radiation and radioactivematerials of both those working with the materialsand the public,*The terms "radiation protection officer" and-radiological safety officer" are synonymous.items 8 and 9. A resume of the training and ex-perience of each person who will directly supervisey the use of material, who will use material without-supervision, or who will have responsibilities forc radiological safety should be submitted. The resumeshould include the type (on-the-job or formal coursework), location, and duration of the training. Train-r ing should cover(1) principles and practices ofradia-I tion protection: (2) radioactivity measurements," standardization, and monitoring techniques and in-t struments, (3) mathematics and calculations basic tothe use and measurement of radioactivity, and (4)-biological effects of radiation. The description of theI use of radioactive materials should include thespecific isotopes handled, the maximum quantities ofmaterials handled, where the experience was gained,n the duration of experience, and the type of use. Thequalifications, training, and experience of eachperson should be commensurate with the materiale and its use as proposed in the application. Theamount and type of training and experience withradiation and radioactive materials required to sup-port a determination of adequacy by the Commissioni will vary markedly with certain factors.The use of microcurie quantities of a few non-volatile radioactive materials by a person with ae minimum of training and expcrience under preciselyspecified and carefully controlled conditions subjectto the surveillance of a competent and adequatelyy trained radiation protection officer may be justified.I Such minimum training and experience may consistof a few hours of training and experience in the use ofone or more radioactive materials similar to the useproposed in the application under the supervisionI and tutorship of a licensed user.Persons using miillicurie quantities of a number ofradionuclides for general laboratory tracer work un-der unspecified condition should have more exten-sive training and experier.ce and, depending on theexact nature of the proposed program or use ofradionuclides, may need to have completed formal-course work at the college or university level coveringthe areas listed under Item 8 of Form NRC-313.The use of larger quantities of material (ap-proaching a curie) under conditions where a potentialexists for significant loss and ingestion, inhalation, orabsorption of the radioactive material by those work.ing with the material is normally done under carefullycontrolled conditions using specialized equipment. Aperson who is to use radioactive materials inde.pendently under these conditions should not onlyhave a background of formal training in all areas ofItem 8 of Form NRC-313 but should also have exten.sive experience working with radioactive materialand a thorough working knowledge of the equipmentrequired to handle the material safely.10.7-2I | ||
l Items 10 and II. Specify for each radiation detec-tion instrument the manufacturer's name and modelnumber, the number of each type of instrumentavailable, the type of radiation detected (alpha. beta.or gamma), the sensitivity range (milliroentgens perhour or counts per minute), the window thickness inmg/cm2.and the type of use. The type of use wouldnormally be monitoring, surveying, assaying, ormeasuring.Describe the instrument calibration procedure.State the frequency. and describe the methods andprocedures for the calibration of survey and monitor-ing instruments, as well as any other instruments andsystems used in the radiation protection program.such as measuring instruments used to assay scaled-source leak-test samples (see Item 14). contaminationsamples (e.g., air samples, surface "wipe' samples).and bioassay samples (see Item 12).An adequate calibration of survey instrumentsusually cannot be performed with built-in checksources. Electronic calibrations that do not involve asource of radiation arc also not adequate to deter-mine the proper functioning and response of all com-ponents of an instrument.Daily or other frequent checks of survey instru-ments should be supplemented every 6 months with atwo.point calibration on each scale of each instru-ment with the two points separated by at least 50% ofthe scale. Survey instruments should also becalibrated following repair. A survey instrument maybe considered properly calibrated when the instru-ment readings are within +/-10 percent of thecalculated or known values for each point checked.Readings within- +/-20 percent are considered accep-table if a calibration chart or graph is prepared andattached to the instrument.If the applicant proposes to calibrate his survey in-struments, a detailed description of planned calibra-tion procedures should be submitted. The descriptionof calibration procedures should include, as aminimum:a. The manufacturer and model number of eachradiation source to be used.b. The nuclide and quantity of radioactivematerial contained in each source,c. The accuracy of the source(s). The traceabilityof the source to a primary standard should beprovided.d. The step-by-step procedures, including as-sociated radiation safety procedures, ande. The name and pertinent experience of eachperson who will perform the calibrations.If the applicant intends to contract out the calibra-tion of instruments, the name, address, and licensenumher of the Firm should be specified together %% iththe frequency of calibration. The applicant shouldcontact the firm that "rill perform the calibration. todetermine if information concerning calibrationprocedures has been filed with the Commission. Ifinformation concerning calibration procedures hasnot been filed, it should be obtained and submitted.Quantitative measuring instruments used tomonitor the adequacy of containment and con-tamination control such as those used for measuringleak test. air. effluent. bioassay, suork area. andcquipnient contamination samples should usually hecalibrated prior to each use. The procedures and fre-quency for calibration of such instruments should hesubmitted and should include:a. The name of the manufacturer and modelnumber of each of the standards to he used.h. The nuclide and quanity of radioactiVcmaterial contained in each of the standard sources.c. A statement orthe accuracy of each of the stan-dard sources. The source accuracy should be. as aminimum. +/- 5 percent of the stated value andtraceable to a primary standard, such as that main-tained by the National Bureau of Standards.d. Step-by-step calibration procedures and. if ap-propriate. associated radiation safety procedures.ande. The name and pertinent experience of eachperson who will perform the instrument calibrations.hem 12. Personnel monitoring is required if aperson is likely to receive in a calendar quarter 313millirems to the body. 4.69 rems to the estremities. or1.88 reins to the skin (lowcr limits apply to those un-der 18 years of age: see ,20.101 and 20.202 of 10CFR Part 20). Personnel monitoring is also requiredif a person enters a high radiation area (greater than100 millirems per hour). If personnel monitoringequipment will be used. the name of the organizationfurnishing film badge or thermoluminescentdosimeter (TLD) service and the frequency forchanging badges, dosimeters. etc.. should bespecified. If pQcket chambers or pocket dosimeterswill be used, the useful range of the device, in mil-liroentgens. the frequency of reading, and theprocedures for maintaining and calibrating thedevices should be specified.If personnel monitoring will not be used, the appli-cant should submit calculations or documentationfrom radiation surveys that demonstrate that it is un-likely that any individual will receive a dose equal toor greater than that indicated in the precedingparagraph.The applicant should show that the need for bioas-says has been thoroughly considered and should es-tablish the adequacy of the proposed hioassayS010.7-3 Iprogram in relation to the proposed program of useof radioactive material. Bioassays are normally re-quired when individuals work with millicurie 4uun-tities of hydrogen-3. iodine-125. or iodinc-131depending on the type of work, equipment, andpiocedures followed. Other materials man also beused in physical or chemical forms and under condi-tions that present an opportunity for uptake by thebody through ingestion. inhalation, or absorption. Abioassay program to determine and control the up-take of radioactive material should be considered anddiscussed in relation to cach such material.procedure. etc. Regulatory Guide 8.9. "AcceptableConcepts. Models. Equations. and Assumptions for aBioassay Program."' may be consulted.The criteria to he used in determining the need forbioassays, the type and frequency of bioassays thatwill he performed, and the bioassay proceduresshould be specified and described in detail. If a com-mercial bioassav service is to be used, the name andaddress of the firm should be provided.ilioassaf.s may not he substituted for other cle-ments of a safety program such as air monitoring anddispersion control (hoods. glove boxes. etc.) and for%tell-thought-out and ssell-cxecuted handlingprocedures.liem 13. The equipment and facilities for each siteof use should be described in detail. The proposedequipment and facilities for each operation to be con-ducted should he adequate to protect health andminimize danger to life and property. In describingavailable equipment and facilities, the following typesot information should be included, as appropriate:a. Physical plant. laboratory, or working areafacilities. Fume hoods, glove boxes, waste recep.taces, special sinks, ventilation and containmentsystems, effluent filter systems, and all processing,work. and protective clothing change areas should bedescribed.b. Containers. devices. protective clothing, aux-iliary shielding, general laboratory equipment, airsampling equipment, etc., actually employed in thedaily use of material. Special provisions for shieldingand containment to minimize personnel exposureshould be described.c. Storage containers and facilities. These shouldprovide both shielding and security for materials.d. The number, type. and length of remote handl-ing devices.* A copy of this guide may he obtained by a written requestto the U.S. Nuclear Rcgulatory Commission. Washington.D).C. 20555., Attention: Director. Office of StandardsDevelopment.lIent 14.a. Survey Program. Commission regulations re-quire that surveys be made to determine if radiationhazards exist in a facility in which radioactivematerials are used or stored (see §20.201. 10 CFRPart 20). A survey should include the evaluation ofexternal exposure to personnel, concentrations of air-borne radioactive material in the facility, andradioactive effluents from the facility. Although atheoretical calculation is often used to demonstratecompliance with regulations regarding airborne orexternal radiation, it cannot always be used in lieu ofa physical survey.Except for those cases where sources of radiationand radioactive material are well known and ac-curately and precisely controlled. it will usually benecessary that a physical survey be made with ap-propriate detection and measurement instruments todetermine the nature and extent of radiation andradioactis material or, as a minimum, confirm theresults of a theoretical determination.A radiation protection program should include thefollowing surveys for radioactive contamination andradiation:(I) In laboratory areas (e.g., checking for con-tamnination on bench tops, handling and storageequipment, clothing, hands, etc.).(2) Whilc work is being done with radiation orradioactivc materials (e.g.. breathing zone air sur-veys: general air surveys; personnel exposuremeasurements, including eyes and extremities: check-ing shutters and containment. etc.).(3) In areas associated with disposal or releaseof radioactive materials (e.g., checking disposal con-tainers and disposal sites: liquid, gas, and solid ef-fluents: filters and filter-duct systems: etc.).The frequency of surveys will depend on the natureof the radioactive materials and their use. However.surveys should be performed prior to the use ofradioactive materials in order to establish a baseline.The surveys should be repeated when radioactivematerials arc present, when the quantity of materialpresent changes, or when changes occur in their con-tainment systems or methods of use. Repetitive sur-veys may also be necessary to control the location ofradioactive materials in the handling system and intic case of the use of sealed sources outside a shieldedcontainer.For operations involving materials in gas, liquid,or finely divided forms, the survey program should bedesigned to monitor the adequacy of containmentand control of the materials involved. The programshould include air sampling, monitoring of effluents,010.7-4 and surveys to evaluate contamination of personnel,facilities, and equipment.The description of an air sampling program shouldinclude the area where samples will be taken, the fre-quency of sampling, and the location of the samplerwith respect to workers' breathing zones. Assays per-formed to evaluate air samples and the methods usedto relate results to actual personnel exposures shouldalso be described.The effluent monitoring program for releases tounrestricted areas should encompass all airborne andliquid radioactive material releases. Theoreticalevaluations should be suppLmcnted by stackmonitoring, water sampling, and nther environmen-tal monitoring appropriate for thc planned andpotential releases.For operations involving only sealed sources, asurvey program should include evaluation and/ormeasurement of radiation levels for storage and useconfigurations. When sources are used in deviceshaving "on" and "ofr' positions. both positionsshould be evaluated at the time of installation. Sup-plemental surveys should be performed following anychanges in operation, shielding, or use.The types. methods. and frequency of surveysshould be specified. Guidance may be obtained fromthe National Council on Radiation ProtectionReport No. 10. "Radiological Monitoring Methodsand Instruments,*' and the International AtomicEnergy Agency's Technical Rcport Series No. 120."Monitoring of Radioactive Contamination on Sur-faces."*b. Records Management Program. Provision forkeeping and revicwing records of surveys: materialsinventories: per'sonnel exposures; receipt. use. anddisposal of materials. etc.. should be described.Persons responsible for keeping and reviewingrecords should be identified.c. Emergency Procedures. The applicant shouldsubmit written emergency procedures for-employeesin case of spills. fires, release or loss of material, oraccidental contamination of personnel, includingdecontamination procedures and the names ofpersons who arc to be notified in an emergency.d. Sealed-Source Leak-Test Procedures. Sealedsources containing more than 100 microcuries of abeta or gamma emitter or more than 10 microcuriesof an alpha emitter must be leak tested at 6-month in-tervals. Leak testing of alpha-particle-emittingsources containing more than 10 microcuries of an*Copies may be obtained from NCRP Publications, P.O.Box 4867. Washington. D.C. 20008.69Copies may be obtained from UNIPUB. Inc.. P.O. Box433. New York. N.Y. 10016.alpha emitter is rcqliired at 3-month intervals. If acommercial firm is to perform the Irak tests, thename. address. and license number of the firm shouldhe submitted, If the tests arc to be performed using acommercial "kit." the name of the kit manufactureror distributor and the kit model designation shouldbe given. If the applicant intends to p.rform his ou nleak tests without the use of a commercial kit, the fol.lowing information should be submitted:I) Qualifications of personnel who will performthe leak test.(2) Procedures and materials to be used in tak-ing test samples.(3) The type manufacturer's name. modelnumber, and r;4iajiin detection and measurementcharacteristics o the'nstrument to be used for assayof test samples.(4) lnstruwment calibration procedures., includingcalibration source characteristics. make. and modelnumber, and(5) The method, including a sample calculation.to be used to convert instrument readings to units ofactivity. e.g.. microcurics.hctm 15. The procedures for disposing ofbyproduct material waste should be described. UnderNRC regulations, a licensee may dispose of waste inthe following ways:a. Transfer to a person properly licensed to receivesuch waste in conformance with paragraph 20.301(a)of 10 CFR Part 20. The name of the firm (whichshould be contacted in advance to determine an%limitations that the firm may have on acceptance ofwaste) should be given.b. Release into a sanitary sewer in conformancewith §20.303 of 10 CFR P:trt 20. Depending on waterusage. releases of up to I curie per year are permitted.c. Burial in soil in conformance with §20.304 of 10CFR Part 20. Up to 12 burials per year are permissi-ble. The allowable quantity depends upon theradionuclide.d. Release into air or water in concentrations inconformance with §20.106 of 10 CFR Part 20. Possi-ble exposure to persons offsite limits the amount thatmay he released.e. Treatment or disposal by incineration in confor-mance with §20.305 of 10 CFR Part 20. This must bespecifically approved by the Commission.f. Other methods specifically approved by theCommission pursuant to §20.302 of 10 CFR Part 20.E010.7-5 | |||
5. AMENDMENTS TO LICENSESS. RENEWAL OF A LICENSELicensees are required to conduct their programsin accordance with statements, representations, andprocedures contained in the license application andsupportive documents. The license must therefore beamended if the licensee plans to make any changes infacilities, equipment (including monitoring and sur-vey instruments), procedures, personnel, orbyproduct material to be used.Applications for license amendments may be filedeith.r w. the application form or in letter form. Theapplication should identify the license by number andshould clearly describe the exact nature of thechanges, additions, or deletions. References topreviously submitted information and documentsshould be clear and specific and should identify thepertinent information by date, page. and paragraph.An application for renewal of a license should befiled at least 30 days prior to the expiration date. Thiswill ensure that the license does not expire until finalaction on the application has been taken by the NRCas provided for in paragraph 30.37(b) of 10 CFR Part30.Renewal applications should be filed on FormNRC-313, appropriately supplemented, and shouldcontain complete and up-to-date information aboutthe applicant's current program.In order to facilitate the review process, the ap-plication for renewal should be submitted withoutreference to previously submitted documents and in-formation. If such references cannot be avoided. theyshould be clear and specific and should identify thepertinent information by date, page, and paragraph.S00I10.7-6 OAPPENDIXForm AIC-313 UNITED STATES ATOMC eNerGY COCMISSION10 CIA 30 APPLICATION FOR BYPRODUCT MATERIAL LICENSE 'e"" " oUSSTRUCT"OF4S.-Complate Horns 1 through 16 if this Is an iritiil applic4alon of an application for henewal of a license. Informiaton contaled an r.vius applicatlOnls (dd with the CommItf4ah n with respect to Items 0 through 15 mey be incoporlteo by reflerence promded rterences at# ci.so andispiochc. Use supplemental shoets whire nTcussaty. Item 15 must be completed on all Maii two copies Wo U S Atomic Energy Comms-ioa. Washington. D.C.. 20545, Attention: Matiials Branch. Direclorate of ULcensing. upon approval of this application. the applicaml win an AECByproduct Material Lcn"s. An AEC Byproduct Material Uclnts Is Issued In accordance with the general requirements contained in Tnl 10. Code of Fed-ratl Flegulation. Pail 30, and the Is subject to Title 10, Code of Federal Rgplatioti4. Pan 20. and the ft ptovisions ot Tifle 10. Code ofFederal Regulations, PaiR 170. The license fee cateqory should be staled in Haem 16 and the appropriate lee enclosed. (See Nloe in Instrueloen sheoel1. (a) kAME AND STRET AlOMlSS OF APPIUCANT. (htitutftbi. Iran. tiloagH per. 11.1 StWall ADD* SSIISI AT WHiiCa 57P500UCI .AIIIIAt WJLl U LJ*IO sifSoo. 0rC baciw* D Code mod blofphof. nvmber1 I &Wsitk... 11. &via.%ZFCO. I2. DIPAX1XINI TO UISE itSOUOV kAUTINIAt3. PRIVIOtJI SIINIL MUMMIES[$) fit ika'a m. pM Vo P..af k~~isi ~~phm.; -daf aid 9-. ý IS4. INDIVIDUAL US~IRIS. (Naue O~d irffet Of..dsia --it iii -itwriy 5 IAW'ONA)A Pa"tC"0#N O#I1CAR (P of pim d*..p..dm a. a.0- pýu1w O. jOoe 0c W.-AMI5. -A~anw 'a-o o A.. tm.- ami "pi"__ ~ ~ ~ ~ ~ ~ ~ ~ a A4 bp~ds I C..rogo*Eu ei5d 9.1e. (1) WTPOVUCT MAT11RIAL.' it sewwwa lb) OUMICAL AND/Oft PKTSICAL FO"M ANP MAAVMUM NUM29S Or s~AQUICL111 Of 1ACM C~iLMiCAL ANDOS1 011M"-Winm -1d. *F00,11kJ 'CAL 0M hAiTYOP.)WniPOSMSSA At AN PT OEns araae oarll ia I ~ edo Oakba... u~ifb.W. f6OWW an W mo -.- Oti-o Pat- SO7. 592S PW5l PMW1KCN ITODUCT MAlKUA WILL MUED lxi i 7m n.W .M A .p5Mue A FioeAliC.31J i4 A? a. owsis li.en *I " t. If 6wied" -is in go him of, a weld am. 6KAi6 Ow ..c ed &.d. aw" oiiwv at' "S iOwua toogewin opifa ds..s Mi. EA ftev #ow -he dftfd end/ar usd1l.0lCemlieafed on nriesin side)310.7-7 | |||
1RAINING AND EXPERIENCI: OF EACH INDIVIDUAL NAMED IN ItEM 4 evi..I.nnO AesI ..e'I ____* TYPE OF TRAININGa 1"..P0 o:j p tfcs Fyes Ida Yes Nolo5d~oact..lp -tt,@* sandacfS.d:a o 1. NIQ '. a-''il -o'do- SO40oI'.O' oI o, Ys No Yet NoI .an Aluho ob s cmd .n C090 Pfn bo~ oce$- _______0_____ t...-.yet--No-.V.s NO8 .bi* o and~ of | |||
* ad -000-0 y es NoYe9 (IIIIIIENCI WIT" 11AOIATION fA,*.~aI wo. of 'ada -1aapes of*..'~$*p.4'Sot0o' ..jU AOJi ."let trot-SINci WAS rAINID DUIAIO Al ots 001PIIIINCI ITYP OP ust10 kADIAftON (ITICTION INSTRUMENIS r~it woo1nronamo skeelt .4 notospo, IFIlE of INSIIUMINI5 U II -.DAT -(. S --'at I ý O KINUISS1SA-IT.O Uýdi~t -d.?1 TWINOO II Dilib..,~~~~~~~~~~~~~~~~~~~~c 1. d.0'Dbo i~ VAIStIDT~I I j 9* ~ ~ eng ~~~ .gI I M"flOO. PRIOV(PE.CV. A-4 SIANDANDS USED IN CALISILAIIINC, INSTIUPAIMIS LISTED ASIDVI42 U.MLADES.OOSM!TSI.AND 110 ASSAY PROCIDUIIt USED (P I ade. wseo:4P 'n*Aod of tot-beaoa 00of 5~CI aoi-. 4w -0.0 of s.aJpohINFOPLAATFON TO S1 SUBMITTED ON ADDITIONAL SHIRTS IN DUPLICATE13 FACIIIII AND EQUIPMENT Desc-b. Iebaoatwy let1,hmeo end m-Moh he-dllsg stlyp~ei. stwage cemo'a j. 1%...Id--, P..-O Noojs, sto: 1.010,4a'.. iA.NI.4 116olo .0 ovoothe pCa,4. ao"sl yet No14 NADIATION P1OTICTION FI0155AM Dssw.,be Ike a0.4466A P-eetheft OKOI-w- dtcWdg CO-9101 ..eaiQ,.i 10 *gpIoqQ40e to... stated .o.e .~b.,q I"%L1811.1. p*d..'e .e apoI,4bI.. nOG.. 04-~q, aend espe,,.#.e of pesonb to peio,voos Loot Wie4. 0. ..nndn,1 o'an ,A.,0-0 fad-011" W-09.,,.0-2. and~~t 0. 19po., 94 1%* tw-to,*I I WASTE DolSPO141 I ag commudsng. erete d-iflesal get-te sI eeilaygod. gpoilPy oeos of tolosopon. 01onso.$S~. febll,t de'a.1*4 dec.pI 4 -sA ..4.4k .jIbe .sod #a, dopooo-o of sod-oath*. -01111 and ash-Wet., I%#0 hPe and ....otl of O(.socino.o1 Inelod,CERTIFICATE (This Item must be completed by applicant)40 11`11 APPLICANT1 AND ANY OFFICIAL. EXECUTING 18441 C1IITIPICAll ON SItHA Of T111 APPIICAMT NAMED IN ITEMA 1. CERTIFY THAT 1THIS AMIIC.A1TON ISPIEP4210 IN CONIFOMITY WT1H ?MEs 10. Cool Of FDERAL IIGULAT)Ok$. PAl? 30. AID tHAI Att4 INPOIM.ATION CONTAINED '4151484. iNCLuviNo ANYSUPPIsotMINT ATTACIOID MINE1O. IS TRnUE AND0 cosIXEC TO TE1)111 OFl OPI Out KNOWSIO AND MIItWcAna. foe CeI0o'ga~yS___________F" (nfim.ed IApp4.cae sma-W o 4. 1by;Tal u cvnfyinq .AcilSDocteWAINIO.-ISI U. S. C.. $oeehen 100 1 Ali of Joao 25. 194 81 62 Stag. 749; mvaligi t a5 uuiskinal offeftse go MO%0 a *itlfvllrfa 4,1,. loafenI orfOMAtM11 SO 4pep AA dee lotle 094onty Of IhO Unsled Slates Iast any wallet -ithin ift mos.d,efieam.61.15.11-P100 1973-043.126/21010.7-s | |||
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Revision as of 09:02, 22 March 2018
ML13350A227 | |
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Issue date: | 02/28/1977 |
From: | NRC/OSD |
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References | |
RG-10.007 | |
Download: ML13350A227 (8) | |
..:U.S. NUCLEAR REGULATORY COMMISSION FebruarySREGULATORY GUIDEbOFFICE OF STANDARDS DEVELOPMENTREGULATORY GUIDE 10.7GUIDE FOR THE PREPARATION OF APPLICATIONS FOR LICENSESFOR LABORATORY USE OF SMALL QUANTITIES OFBYPRODUCT MATERIAL.19771. INTRODUCTIONThis..guide describes the type of informationneeded by the NRC staff t1 evaluate an application.. fforea specific license for laboratories using millicuriequantities of hbproduct material (reactor-producedradionuclides). This type of license is provided for..under Title 10. CodeofrFederalRegulations. Part 30.-Rules of General Applicability to Licensing ofByproduct Material.-S.Paragraph 20.1(c)-of 10 CFR Part 20. "Standardsfor Protection Against Radiation." states that"..persons engaaed in activities under licenses issued hythe Nuclear Regulatory Commission pursuant to theAtomic Energy Act of 1954. as amended, and the* .Energy. Reorganization Act of 1974 should. in addi-,ton tocomplying with the requirements set forth inthis part, make everv-reasonuhle effort to maintain..diation exposures. and rleases of radioactve.materials: n einlucLnts to unrestricted arcas.as-low as iis reasonabhl ahtcvahich" (A LAR_). Rcgu titatol3'SGude-8.10. " )Operating. Philosophv IrI Maintaining"Occupational Radiation Exposures AssLow As IsReasonabhh Achiev.,, provides thc*RC staffposition on thi. iamirta l1_subject. License applicantsshould g-, 0on;'. 60tion to the A LA RAphilos inWRegulatory Guide 8.10. inI v Fln tif 01ans for work with licensedra ct b~6uial'° 2. LICENSE FEESAn application 'fee. is required for most types oflicenses. The applicant should refer -to §170.31."Schedule of Fees.for Materials Licenses." of 10* "CFR Part 170 to determine the amountof fee thatmust accompany the application. Review of the ap-plication will not Iwgin ut, il the proper fee is receivedby the NRC.3. FILING AN APPLICATIONA licenew application for by product nmuterialshould he suhmitted tfi Form NRC 313* ",'Applica-lion for Byproduct Miaterial l.iLcnsC (%L ibe appeu-di\ to this guide). All items on the zpplicuaiib6 formshould he completed in sutTicicnt dotuil for thc NRCit) determine thatil fit uppikil ntls:"t'qUipllellt.facilities. and rai~oio~to reanare ade-qultte it) protect,ý, iL~lth Andrii~tsn~imi datnger to lifeand proprt'. "hc.h spce' provided on Form NRC-313 isirhmited1. applctant should append additionalto provide complete information. F:achse .paratc sheet or document subLtllted with the ap-plicalion should he identified by a heading indicatingthe appropriate item number (on Form NRC-313)and its purpose (e.g.. radiation safety instructions).The applica.tion should lie completed in triplicaite.The original and one copy should he mailed to:Radioisotope:, Licensing Branch. Division of FuelCvyec aod MIatertal Safety. Office of NuclearMaterial Safety and Safeltuards. U.S. NuclearRegulatory Commission. Washington. D.C. 20555.One copy of the application. with all attachments.should he retained by the applicant, since the licensewill require. as :t condition. that the institution follo-wthe stLtcmenits and representations set forth in the ap-plication and any stIpplememt to it.* Form N R C-13 Was foirmerly designated Form ALEC-313.Exisling copies or F:osrm AIEC.-313 m:A, still hb used.USNRC REGULATORY GUIDES CAI~~r .jui,uki Is W. wrt to It', 5m'routy tr ttv Ci.. t mswn.tUf tim.le iof,Rewlimka G...k .ri-w t..elf to dilcisLso ..fs.Ie -o,Ia.ble to the utisbtc flwtithods Ulm*, C ..... ...,%u-. Vd- nl M ....o. 1) C. O.d *i't.. .. o-airmmultle to low NRC sulst of mtIflenrq '.010.s Itan at 03l COMM3w' Woinch.tOt4t10 t*~1 flts. ,1t wt ý~t by It.I stif %WC11C Ifflibleeril I, I- ju .rt.3~ I .t3 ,,to Tam" ty o .0 .1ofrm olttui..~ Mac tilm , n, to ifrtle awato nirr t i tn 4ilic..so. Olovuliirey GutcirWit not ,ttu~itut.. l0r e.,wPsUIitM1. 'e not Ijo Vitth thnro 0, not feitu,111.. .Pr. ~~aqnf ~,tI.11.S the~s & t eC.1 w tuu- i d tfrm ,llanjlo w le t.1 .. Ihe qu .33 willto, AMIc. .1. ru-t.... P sI Itf-y ntso i.O55.I1C0t4tha'l at they ji or id ani WIWI It~e CaInv! ni ..jrlt in JIM stuoo~nn"u oat Smioriit .. 8. 0.,ro , Id) It -It0 C A mI W it u O f Id I I.. p J u t 4 fl .1 C ~ I O~ n 0i eWM ' t 4 , 0 .3 9 A i mlt, , 9 I l e .-e ivtt 4 3 s t;s9t .sj.g- yi .st. ,w te. i ,u4 ~ M 3 O*W rt.."c j.s",' It.s-~r ti !Jt. pltn3l3 5107M .t ,tn tt" t0 G4u eti t~Iott*.t..t 0Iitt* lit eltIc tree. stume";nt.k (SI ..3..'inero.. i thoerift ennsn)on t 00 eff, r if" ~ .own illatt.tc Urttt.sj it striitl tto l stt. t~.PItO.Im-1 infW i will lie 0th in 5' " *' Sit) 15 IJIC~tio etot "" I stnsosrn r sIt I. mq ..t M1 5i of I3~ mae Io-fsir, (uS. Ns.ts.I0,, l-itsltshoty .31 sI'sl s'y~.to f 5SQ~ t Sne s nfo In f .sit C .sl..tn. ..on"o on .i~gsd " nwWMr.wtrS, 0C 15s, tfl ti. f ttt' u ..t O il.50tit ii s.0
4. CONTENTS OF AN APPLICATIONMost items of Form NRC-313 are sclf-explanator:(se instructions with the form). The following cornments apply to the indicated numbered items of th.form.hIem 1(a). Specify the applicant corporation oother legal entity by name and address of principaoffice. Individuals should be designated as the applicant only if the use of the byproduct material is noconnected with the individual's employment withcorporation or other entity. If the applicant is an individual, the individual should be specified by fulname and address, including state and zip code.hem 1(h). Specify the street address of the locatiorof use if the address differs from the one given in itcrrI(a). If use is to be at more than one location. thispecific address of each should be given. Describe thiextent of use and the facilities and equipment at eacalocation. A post office box address is not acceptableItem 4. Specify the names of the persons who wildirectly supervise the use of radioactive material oiwho will use radioactive material without supervi.sion.hem 5. Specify the name of the person who will htdesignated as the radiation protection officer.* Thisperson should be responsible for implementing th(radiation safety program and therefore readilyavailable to the users in case of difficulty and shouldbe trained and experienced in radiation protectiorand in the use and handling of radioactive materials.Ite't 6(a i amdl 1b. Describe the byproduct rnatcriaby isotope, chemical and/or physical form. and ac.tivity. in millicuries or microcurics. A separate pos.session limit for each nuclide should be specifiedPossession limits requested should cover the total an.ticipated inventory, including stored materials andwaste. and should be commensurate with the appli-cant's needs and facilities for safe handling.If the use of sealed or plated sources is con-templated, the isotope. manufacturer, and modelnumber of each sealed or plated source should beIf a source will be used in a gaschromatograph, gauge, or other device. the manufac-turer and model number of the device should bespecified.Item 7. The use to be made of the radioactivematerials should be clearly described. Sufficientdetail should be given to allow a determination of thepotential for exposure to radiation and radioactivematerials of both those working with the materialsand the public,*The terms "radiation protection officer" and-radiological safety officer" are synonymous.items 8 and 9. A resume of the training and ex-perience of each person who will directly supervisey the use of material, who will use material without-supervision, or who will have responsibilities forc radiological safety should be submitted. The resumeshould include the type (on-the-job or formal coursework), location, and duration of the training. Train-r ing should cover(1) principles and practices ofradia-I tion protection: (2) radioactivity measurements," standardization, and monitoring techniques and in-t struments, (3) mathematics and calculations basic tothe use and measurement of radioactivity, and (4)-biological effects of radiation. The description of theI use of radioactive materials should include thespecific isotopes handled, the maximum quantities ofmaterials handled, where the experience was gained,n the duration of experience, and the type of use. Thequalifications, training, and experience of eachperson should be commensurate with the materiale and its use as proposed in the application. Theamount and type of training and experience withradiation and radioactive materials required to sup-port a determination of adequacy by the Commissioni will vary markedly with certain factors.The use of microcurie quantities of a few non-volatile radioactive materials by a person with ae minimum of training and expcrience under preciselyspecified and carefully controlled conditions subjectto the surveillance of a competent and adequatelyy trained radiation protection officer may be justified.I Such minimum training and experience may consistof a few hours of training and experience in the use ofone or more radioactive materials similar to the useproposed in the application under the supervisionI and tutorship of a licensed user.Persons using miillicurie quantities of a number ofradionuclides for general laboratory tracer work un-der unspecified condition should have more exten-sive training and experier.ce and, depending on theexact nature of the proposed program or use ofradionuclides, may need to have completed formal-course work at the college or university level coveringthe areas listed under Item 8 of Form NRC-313.The use of larger quantities of material (ap-proaching a curie) under conditions where a potentialexists for significant loss and ingestion, inhalation, orabsorption of the radioactive material by those work.ing with the material is normally done under carefullycontrolled conditions using specialized equipment. Aperson who is to use radioactive materials inde.pendently under these conditions should not onlyhave a background of formal training in all areas ofItem 8 of Form NRC-313 but should also have exten.sive experience working with radioactive materialand a thorough working knowledge of the equipmentrequired to handle the material safely.10.7-2I
l Items 10 and II. Specify for each radiation detec-tion instrument the manufacturer's name and modelnumber, the number of each type of instrumentavailable, the type of radiation detected (alpha. beta.or gamma), the sensitivity range (milliroentgens perhour or counts per minute), the window thickness inmg/cm2.and the type of use. The type of use wouldnormally be monitoring, surveying, assaying, ormeasuring.Describe the instrument calibration procedure.State the frequency. and describe the methods andprocedures for the calibration of survey and monitor-ing instruments, as well as any other instruments andsystems used in the radiation protection program.such as measuring instruments used to assay scaled-source leak-test samples (see Item 14). contaminationsamples (e.g., air samples, surface "wipe' samples).and bioassay samples (see Item 12).An adequate calibration of survey instrumentsusually cannot be performed with built-in checksources. Electronic calibrations that do not involve asource of radiation arc also not adequate to deter-mine the proper functioning and response of all com-ponents of an instrument.Daily or other frequent checks of survey instru-ments should be supplemented every 6 months with atwo.point calibration on each scale of each instru-ment with the two points separated by at least 50% ofthe scale. Survey instruments should also becalibrated following repair. A survey instrument maybe considered properly calibrated when the instru-ment readings are within +/-10 percent of thecalculated or known values for each point checked.Readings within- +/-20 percent are considered accep-table if a calibration chart or graph is prepared andattached to the instrument.If the applicant proposes to calibrate his survey in-struments, a detailed description of planned calibra-tion procedures should be submitted. The descriptionof calibration procedures should include, as aminimum:a. The manufacturer and model number of eachradiation source to be used.b. The nuclide and quantity of radioactivematerial contained in each source,c. The accuracy of the source(s). The traceabilityof the source to a primary standard should beprovided.d. The step-by-step procedures, including as-sociated radiation safety procedures, ande. The name and pertinent experience of eachperson who will perform the calibrations.If the applicant intends to contract out the calibra-tion of instruments, the name, address, and licensenumher of the Firm should be specified together %% iththe frequency of calibration. The applicant shouldcontact the firm that "rill perform the calibration. todetermine if information concerning calibrationprocedures has been filed with the Commission. Ifinformation concerning calibration procedures hasnot been filed, it should be obtained and submitted.Quantitative measuring instruments used tomonitor the adequacy of containment and con-tamination control such as those used for measuringleak test. air. effluent. bioassay, suork area. andcquipnient contamination samples should usually hecalibrated prior to each use. The procedures and fre-quency for calibration of such instruments should hesubmitted and should include:a. The name of the manufacturer and modelnumber of each of the standards to he used.h. The nuclide and quanity of radioactiVcmaterial contained in each of the standard sources.c. A statement orthe accuracy of each of the stan-dard sources. The source accuracy should be. as aminimum. +/- 5 percent of the stated value andtraceable to a primary standard, such as that main-tained by the National Bureau of Standards.d. Step-by-step calibration procedures and. if ap-propriate. associated radiation safety procedures.ande. The name and pertinent experience of eachperson who will perform the instrument calibrations.hem 12. Personnel monitoring is required if aperson is likely to receive in a calendar quarter 313millirems to the body. 4.69 rems to the estremities. or1.88 reins to the skin (lowcr limits apply to those un-der 18 years of age: see ,20.101 and 20.202 of 10CFR Part 20). Personnel monitoring is also requiredif a person enters a high radiation area (greater than100 millirems per hour). If personnel monitoringequipment will be used. the name of the organizationfurnishing film badge or thermoluminescentdosimeter (TLD) service and the frequency forchanging badges, dosimeters. etc.. should bespecified. If pQcket chambers or pocket dosimeterswill be used, the useful range of the device, in mil-liroentgens. the frequency of reading, and theprocedures for maintaining and calibrating thedevices should be specified.If personnel monitoring will not be used, the appli-cant should submit calculations or documentationfrom radiation surveys that demonstrate that it is un-likely that any individual will receive a dose equal toor greater than that indicated in the precedingparagraph.The applicant should show that the need for bioas-says has been thoroughly considered and should es-tablish the adequacy of the proposed hioassayS010.7-3 Iprogram in relation to the proposed program of useof radioactive material. Bioassays are normally re-quired when individuals work with millicurie 4uun-tities of hydrogen-3. iodine-125. or iodinc-131depending on the type of work, equipment, andpiocedures followed. Other materials man also beused in physical or chemical forms and under condi-tions that present an opportunity for uptake by thebody through ingestion. inhalation, or absorption. Abioassay program to determine and control the up-take of radioactive material should be considered anddiscussed in relation to cach such material.procedure. etc. Regulatory Guide 8.9. "AcceptableConcepts. Models. Equations. and Assumptions for aBioassay Program."' may be consulted.The criteria to he used in determining the need forbioassays, the type and frequency of bioassays thatwill he performed, and the bioassay proceduresshould be specified and described in detail. If a com-mercial bioassav service is to be used, the name andaddress of the firm should be provided.ilioassaf.s may not he substituted for other cle-ments of a safety program such as air monitoring anddispersion control (hoods. glove boxes. etc.) and for%tell-thought-out and ssell-cxecuted handlingprocedures.liem 13. The equipment and facilities for each siteof use should be described in detail. The proposedequipment and facilities for each operation to be con-ducted should he adequate to protect health andminimize danger to life and property. In describingavailable equipment and facilities, the following typesot information should be included, as appropriate:a. Physical plant. laboratory, or working areafacilities. Fume hoods, glove boxes, waste recep.taces, special sinks, ventilation and containmentsystems, effluent filter systems, and all processing,work. and protective clothing change areas should bedescribed.b. Containers. devices. protective clothing, aux-iliary shielding, general laboratory equipment, airsampling equipment, etc., actually employed in thedaily use of material. Special provisions for shieldingand containment to minimize personnel exposureshould be described.c. Storage containers and facilities. These shouldprovide both shielding and security for materials.d. The number, type. and length of remote handl-ing devices.* A copy of this guide may he obtained by a written requestto the U.S. Nuclear Rcgulatory Commission. Washington.D).C. 20555., Attention: Director. Office of StandardsDevelopment.lIent 14.a. Survey Program. Commission regulations re-quire that surveys be made to determine if radiationhazards exist in a facility in which radioactivematerials are used or stored (see §20.201. 10 CFRPart 20). A survey should include the evaluation ofexternal exposure to personnel, concentrations of air-borne radioactive material in the facility, andradioactive effluents from the facility. Although atheoretical calculation is often used to demonstratecompliance with regulations regarding airborne orexternal radiation, it cannot always be used in lieu ofa physical survey.Except for those cases where sources of radiationand radioactive material are well known and ac-curately and precisely controlled. it will usually benecessary that a physical survey be made with ap-propriate detection and measurement instruments todetermine the nature and extent of radiation andradioactis material or, as a minimum, confirm theresults of a theoretical determination.A radiation protection program should include thefollowing surveys for radioactive contamination andradiation:(I) In laboratory areas (e.g., checking for con-tamnination on bench tops, handling and storageequipment, clothing, hands, etc.).(2) Whilc work is being done with radiation orradioactivc materials (e.g.. breathing zone air sur-veys: general air surveys; personnel exposuremeasurements, including eyes and extremities: check-ing shutters and containment. etc.).(3) In areas associated with disposal or releaseof radioactive materials (e.g., checking disposal con-tainers and disposal sites: liquid, gas, and solid ef-fluents: filters and filter-duct systems: etc.).The frequency of surveys will depend on the natureof the radioactive materials and their use. However.surveys should be performed prior to the use ofradioactive materials in order to establish a baseline.The surveys should be repeated when radioactivematerials arc present, when the quantity of materialpresent changes, or when changes occur in their con-tainment systems or methods of use. Repetitive sur-veys may also be necessary to control the location ofradioactive materials in the handling system and intic case of the use of sealed sources outside a shieldedcontainer.For operations involving materials in gas, liquid,or finely divided forms, the survey program should bedesigned to monitor the adequacy of containmentand control of the materials involved. The programshould include air sampling, monitoring of effluents,010.7-4 and surveys to evaluate contamination of personnel,facilities, and equipment.The description of an air sampling program shouldinclude the area where samples will be taken, the fre-quency of sampling, and the location of the samplerwith respect to workers' breathing zones. Assays per-formed to evaluate air samples and the methods usedto relate results to actual personnel exposures shouldalso be described.The effluent monitoring program for releases tounrestricted areas should encompass all airborne andliquid radioactive material releases. Theoreticalevaluations should be suppLmcnted by stackmonitoring, water sampling, and nther environmen-tal monitoring appropriate for thc planned andpotential releases.For operations involving only sealed sources, asurvey program should include evaluation and/ormeasurement of radiation levels for storage and useconfigurations. When sources are used in deviceshaving "on" and "ofr' positions. both positionsshould be evaluated at the time of installation. Sup-plemental surveys should be performed following anychanges in operation, shielding, or use.The types. methods. and frequency of surveysshould be specified. Guidance may be obtained fromthe National Council on Radiation ProtectionReport No. 10. "Radiological Monitoring Methodsand Instruments,*' and the International AtomicEnergy Agency's Technical Rcport Series No. 120."Monitoring of Radioactive Contamination on Sur-faces."*b. Records Management Program. Provision forkeeping and revicwing records of surveys: materialsinventories: per'sonnel exposures; receipt. use. anddisposal of materials. etc.. should be described.Persons responsible for keeping and reviewingrecords should be identified.c. Emergency Procedures. The applicant shouldsubmit written emergency procedures for-employeesin case of spills. fires, release or loss of material, oraccidental contamination of personnel, includingdecontamination procedures and the names ofpersons who arc to be notified in an emergency.d. Sealed-Source Leak-Test Procedures. Sealedsources containing more than 100 microcuries of abeta or gamma emitter or more than 10 microcuriesof an alpha emitter must be leak tested at 6-month in-tervals. Leak testing of alpha-particle-emittingsources containing more than 10 microcuries of an*Copies may be obtained from NCRP Publications, P.O.Box 4867. Washington. D.C. 20008.69Copies may be obtained from UNIPUB. Inc.. P.O. Box433. New York. N.Y. 10016.alpha emitter is rcqliired at 3-month intervals. If acommercial firm is to perform the Irak tests, thename. address. and license number of the firm shouldhe submitted, If the tests arc to be performed using acommercial "kit." the name of the kit manufactureror distributor and the kit model designation shouldbe given. If the applicant intends to p.rform his ou nleak tests without the use of a commercial kit, the fol.lowing information should be submitted:I) Qualifications of personnel who will performthe leak test.(2) Procedures and materials to be used in tak-ing test samples.(3) The type manufacturer's name. modelnumber, and r;4iajiin detection and measurementcharacteristics o the'nstrument to be used for assayof test samples.(4) lnstruwment calibration procedures., includingcalibration source characteristics. make. and modelnumber, and(5) The method, including a sample calculation.to be used to convert instrument readings to units ofactivity. e.g.. microcurics.hctm 15. The procedures for disposing ofbyproduct material waste should be described. UnderNRC regulations, a licensee may dispose of waste inthe following ways:a. Transfer to a person properly licensed to receivesuch waste in conformance with paragraph 20.301(a)of 10 CFR Part 20. The name of the firm (whichshould be contacted in advance to determine an%limitations that the firm may have on acceptance ofwaste) should be given.b. Release into a sanitary sewer in conformancewith §20.303 of 10 CFR P:trt 20. Depending on waterusage. releases of up to I curie per year are permitted.c. Burial in soil in conformance with §20.304 of 10CFR Part 20. Up to 12 burials per year are permissi-ble. The allowable quantity depends upon theradionuclide.d. Release into air or water in concentrations inconformance with §20.106 of 10 CFR Part 20. Possi-ble exposure to persons offsite limits the amount thatmay he released.e. Treatment or disposal by incineration in confor-mance with §20.305 of 10 CFR Part 20. This must bespecifically approved by the Commission.f. Other methods specifically approved by theCommission pursuant to §20.302 of 10 CFR Part 20.E010.7-5
5. AMENDMENTS TO LICENSESS. RENEWAL OF A LICENSELicensees are required to conduct their programsin accordance with statements, representations, andprocedures contained in the license application andsupportive documents. The license must therefore beamended if the licensee plans to make any changes infacilities, equipment (including monitoring and sur-vey instruments), procedures, personnel, orbyproduct material to be used.Applications for license amendments may be filedeith.r w. the application form or in letter form. Theapplication should identify the license by number andshould clearly describe the exact nature of thechanges, additions, or deletions. References topreviously submitted information and documentsshould be clear and specific and should identify thepertinent information by date, page. and paragraph.An application for renewal of a license should befiled at least 30 days prior to the expiration date. Thiswill ensure that the license does not expire until finalaction on the application has been taken by the NRCas provided for in paragraph 30.37(b) of 10 CFR Part30.Renewal applications should be filed on FormNRC-313, appropriately supplemented, and shouldcontain complete and up-to-date information aboutthe applicant's current program.In order to facilitate the review process, the ap-plication for renewal should be submitted withoutreference to previously submitted documents and in-formation. If such references cannot be avoided. theyshould be clear and specific and should identify thepertinent information by date, page, and paragraph.S00I10.7-6 OAPPENDIXForm AIC-313 UNITED STATES ATOMC eNerGY COCMISSION10 CIA 30 APPLICATION FOR BYPRODUCT MATERIAL LICENSE 'e"" " oUSSTRUCT"OF4S.-Complate Horns 1 through 16 if this Is an iritiil applic4alon of an application for henewal of a license. Informiaton contaled an r.vius applicatlOnls (dd with the CommItf4ah n with respect to Items 0 through 15 mey be incoporlteo by reflerence promded rterences at# ci.so andispiochc. Use supplemental shoets whire nTcussaty. Item 15 must be completed on all Maii two copies Wo U S Atomic Energy Comms-ioa. Washington. D.C.. 20545, Attention: Matiials Branch. Direclorate of ULcensing. upon approval of this application. the applicaml win an AECByproduct Material Lcn"s. An AEC Byproduct Material Uclnts Is Issued In accordance with the general requirements contained in Tnl 10. Code of Fed-ratl Flegulation. Pail 30, and the Is subject to Title 10, Code of Federal Rgplatioti4. Pan 20. and the ft ptovisions ot Tifle 10. Code ofFederal Regulations, PaiR 170. The license fee cateqory should be staled in Haem 16 and the appropriate lee enclosed. (See Nloe in Instrueloen sheoel1. (a) kAME AND STRET AlOMlSS OF APPIUCANT. (htitutftbi. Iran. tiloagH per. 11.1 StWall ADD* SSIISI AT WHiiCa 57P500UCI .AIIIIAt WJLl U LJ*IO sifSoo. 0rC baciw* D Code mod blofphof. nvmber1 I &Wsitk... 11. &via.%ZFCO. I2. DIPAX1XINI TO UISE itSOUOV kAUTINIAt3. PRIVIOtJI SIINIL MUMMIES[$) fit ika'a m. pM Vo P..af k~~isi ~~phm.; -daf aid 9-. ý IS4. INDIVIDUAL US~IRIS. (Naue O~d irffet Of..dsia --it iii -itwriy 5 IAW'ONA)A Pa"tC"0#N O#I1CAR (P of pim d*..p..dm a. a.0- pýu1w O. jOoe 0c W.-AMI5. -A~anw 'a-o o A.. tm.- ami "pi"__ ~ ~ ~ ~ ~ ~ ~ ~ a A4 bp~ds I C..rogo*Eu ei5d 9.1e. (1) WTPOVUCT MAT11RIAL.' it sewwwa lb) OUMICAL AND/Oft PKTSICAL FO"M ANP MAAVMUM NUM29S Or s~AQUICL111 Of 1ACM C~iLMiCAL ANDOS1 011M"-Winm -1d. *F00,11kJ 'CAL 0M hAiTYOP.)WniPOSMSSA At AN PT OEns araae oarll ia I ~ edo Oakba... u~ifb.W. f6OWW an W mo -.- Oti-o Pat- SO7. 592S PW5l PMW1KCN ITODUCT MAlKUA WILL MUED lxi i 7m n.W .M A .p5Mue A FioeAliC.31J i4 A? a. owsis li.en *I " t. If 6wied" -is in go him of, a weld am. 6KAi6 Ow ..c ed &.d. aw" oiiwv at' "S iOwua toogewin opifa ds..s Mi. EA ftev #ow -he dftfd end/ar usd1l.0lCemlieafed on nriesin side)310.7-7
1RAINING AND EXPERIENCI: OF EACH INDIVIDUAL NAMED IN ItEM 4 evi..I.nnO AesI ..e'I ____* TYPE OF TRAININGa 1"..P0 o:j p tfcs Fyes Ida Yes Nolo5d~oact..lp -tt,@* sandacfS.d:a o 1. NIQ '. a-il -o'do- SO40oI'.O' oI o, Ys No Yet NoI .an Aluho ob s cmd .n C090 Pfn bo~ oce$- _______0_____ t...-.yet--No-.V.s NO8 .bi* o and~ of
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