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Application for Renewal of License 07-13441-02,Authorizing Use Of WhC W 318 U.S. NUCL444 Rt.UL;TORV COMIsim:0N 89$$75 > ASPROVGO wT OblS io Ce R a n. nue. :=ein m a an ATPLICATION FOR MATERIAL LICENSE- EN ema os6 - 2nh Wf ItetthuCTIOtt$i LEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPLICATION SEND TWO COPIES OF THE LNTIRE COMPLETED APPLICATION TO THE NRC OFFICE $PECIFIED BELOW. , A8PLICAft0ess F001 DtOTRISUTtOfu OF (ktMPT PRODUCTS FILE APPLICAtl0NS WITH. IF YOU ARE LOCATED IN; U.S WUCLEAR REGULAT00lv COMM*Stoe# eL Lise0:8. tNDI ANA lon A, MnCHIGAN, MINNtt0T A, Ml860Vfil. 0Hlo,0R (WVita0N OF f utL CYCLI AND WAf tR6AL $AFETY, edM&& WISCON&iN, StafO APPLICATIONS TO: , WASHsedGTON, DC 3Eme6 U S NUCLE AR REGULATORY COMMIS$tDN. REGl0N ils ALL OTHER PER40se6 FILt APPLlCAft0ess As FOLLOWS,IF TOU Afit Matt RIALS LICENstNG StCTION LOCAftD 888 799 R00$tVELT ROAD 00essf8CTICUT. DSLAWARE. De8TRsCT OF COLUMelA. MAtest, MARYLAesD. 04AteACMuttTTS. sufW 14 AMP 9Hefit NfW JERSET. Ntw VORK, PtN989YLVANIA, AftK Ass &A$. COLOR ADO, lDAHO. R ANSAS, LOussiassa, ascertaesA, NteRasK A, flMODE teLAseO, OR YtRMOstT,98ND APPLICATtoast To: estW esE xiCD, es0RTH DAK07 A. OK LAHOMA, SOUTH DAKOT A, Tt RAS, UT AN, * U $ NUCLt AR RIOULATORY COMMITS 10N. Ilt010N I NUCLt AR MAftR8ALS GAFETV $tCTION D U $ NUCLE AM RIOULATORY COMM18810N Rt010N IV i' 476 LLLINDAtt ROAD W Af TRIAL RADI ATION PROTECTION SECTION i klNQ Of PRU$$44, PA 19401l 611 ftv AN PLAT A DRIVE, SUITE 1000 ' : ALA4 Atha. FLOfilDA. 940fl04A. ElstTUCKy. easteeshePPl. esOflTH CAROllesA. ! PusfrTO R4CO. SOU'M CAllOLINA. Yleesst Stit. YemetNIA, YsR06N ISLAesDS, OR At ASK A, ARl:0esA, CAtlFORNI A. H Attall, NtVADA, OR80008 % ASHINGTON. 14159T Vefl08804A,80880 APPLaCATIOest 70. AND u.s. TtRRITohlet AseD P0estassoses sh THE PActf 6C,94600 APPLICAT10est U S. NUCit AR fit 0VLATORY COMMISSION, REGION 11 WUCIAR MATERIALS $Af TTY StCTION U S NUCLt AA MIGULATORY COMMIES 60N, Riot 0N V 101 MARIETTA STREET, $Ulit 23D NUCLEAR MAf TRIALS $AFFTY 6tCTl0N LTLANTA,GA WED 1480 MARIA LANE SUITE 220 WALNUT CRitK, bA 90008 . I POR30ess LOCAT60 th AGRtEMter? ST ATSt SEND APPLICAf acess To tHe U S. NUCLE AR R600LATORY Coe4Miest0N ONLY IF THEY WitH TO Poesta$ ANO USS LICEN660 MATtRIAL , 188 8T1T86 $USJECT TO U.S. NUCLE AR RE OULATORY CoteM488404 JURISDiCT100s. 1.TH 4 l$ FN APPLICAT6ON FOR (Chace apprspray tesm) 2, NAgg AND MAILING ADDRESS OF APPLICANT flartve Ese Com) - du Pont de Nemours & Co., a. NEW uCthat E. I. Inc. ~ s. AMENDMtNt to uCt=st NUMn R Stine-Haskell Research Center Box 30, Elkton Road (Rt. 2) , T c. RENtWAL OF uCtNst NUMum 07-13441-02 P. O. - Newark, DE 19714-0030 3.LDontalttSP WHERE ($CENBED MAYtRLAL WILL Bt USED OR POEstS6ED. ' E. I. du Pont de Nemours & Co., Inc. , Stine-Haskell Research Center P. O. Box 30, Elkton Road (Rt. 2) > Newark, DE 19714-0030 a NAME OF PERSON TO $4 CONT ACit0 ABOUT THis APPLICATION T E LEPHONI NUMBtR William J.'Maciag, R.S.O. (302)366-5351 SUDIIT titullTHROUGH 110N 8N s 11" PAPER. THE TYPE AND & COPE OF INFORMAf t0N To bt PROVIDED 18 Di$CRISID IN THE LICEN$t APPLICATION OUiOE. S. CAD.80ACT.IVEne MAf TRIAL $ PUf;Posil$l FOR WHICH LICEN$tD MATERIAL WILL 8t u$tD, e (e. ment.a ne P m.se.n.umt.ier. n .n um it. chem..ical end/or phyeesel lerm, end a mes6 mum amount P ' '' ER''' AiNiNo'M " U'PEUNCY ' " "^ ''" " '''""" ""^" '*" "'" * 'a^'N'No 'oa 'ND'v'ou^'8 " oar'No 'N oa 'a'ou'NT'No RE TRieTED ARE As. 9. F AC6'ITitl AND tQUIPMENT, 10. RADIAT10N EAFETY PR00fdM. * 12. LICthstt p tts gaae to CF A J/0eap section f10 J u. eA Tt uAN AatutNT, > et4 CAf to0RY 3L ENCL 0siD s 7 0 0. 0 0 13. CE RTIFICAf t0N f&ust be tamPsese#r apedreast THE APPLICANT UND4RST AND51 HAT ALL $T ATEMENTS AND REPRt5t NT ATIONS MADE IN THis APPLICATION ARE DINDING UPON THE APPLIC ANT. THE APPLICANT AND ANY Of FICIAL ExtCUTING THi$ CERTIFICAf t0N ON SEHAL F f%9 THE APPLtCANT,N AMED IN ITEM 2. CERTIFY THAT THIS APPLICATIOh 18 MIPARID IN CONFORMitv Wif H TITLE 10, CODE OF F(DtRAL Fig.0ULAT;ONb P.M9 30,32,33.34,35, AND 40 AND THAT ALL INFORMATiON CONTAINED HERtlN, 55 TRUS AND CORRECT TO THE Sitt OF THilR ANOWLEOGG AND 81 Lit ?. 1%RNINO 18 U $ C SECTION 1001 ACT OF JUNE 26,194s 62 sT At he Maxis lT A CRIMIN AL OFFENSE TO MAKE A WILLFULLY F AL$t ST ATEMENT OR RtPRESENT Atl0N TO ANY DtPARTa44NT OR AGENCY OF THE UNITED $T Aff s A310 ANY MATTER WITHIN 178 JURISDICTION. NATURE =CtRTif 0F F(C E R PRINTED NAME TIT L E DATE d Maciag Radiation Safety Of fi er 11/22/E 8 - . (40.Wi liam J. t 9002090340 890725 i RE01 LIC30 07-23443-02 PDR FOR NRC U$t ONLY a TYPt 0F Ftt 94 %0G FitCAllGORY COMMENTS APPROYtD S Y r '' ' ' SW ( , p CHt m _ .tR D.,8 we 7T RtCil.tD ?oD MH9/6 10SS G OmCML RECORD COPYfJ NOV 231988 .. 9 o f Item #5 - Radioactive Materials Maximum amount Ry-product, source and/or Chemical and/or possessed at special nuclear material physical form any one time A. Any by-product material A. Any A. 10 mil 11 curies of with atomic numbers each by-product , between 3 and 83 inclusive with atomic numbers except as noted below: between 3 and 83 inclusive except as noted below B. Hydrogen 3 B. Any B. 10 curies C. Carbon 14 C. Any C. 10 curies -D Phosphorous 32 D. Any D. I curie E. Sulfur 35 E. Any E. 5 curies F. Chlorine 36 F. Any P. 200 mil 11 curies G. Chromium 51 G. Any G. I curie H.. Iodine 125 H. Any H. I curie I. Iodine 131 1. Any 1. I curie By product, source and/or Chemical and/or Maximum special nuclear material physical form amount J. Nickel 63 J. Foils contained J. Not to exceed in Hewlett-- 15 mil 11 curies Packard or Perkin each or 1 curie Elmer detector total. cells. K. Americium 241 K.. Sealed check K. Two sources of sources for LSC 0.001 millicurie. PRIAS Instruments Manufactured by Packard. _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - - - . - - - - - _ - _ - - _ - - . - -- - - . - - _ . - - _ - _ - - . - . _ - - - - - . - - . - - - _ - - - - - - - - - - . ,, '' . , . < Item #6 - Purpose (s) For Which Licensed Material Will Be Used 1. Licensed material shall be used only at the licensee's Stine-Haskell Research Center,.Elkton Road, Newark, Delaware 19714-0030. 2. The licensee shall comply with the provisions of Title 10. Chapter 1, Code of Federal Regulations, Part 19. " Notices, Instructions and Reports to Workers; Inspections" and Part 20, " Standards for Protection Against Radiation." 3. Detector cells containing licensed material may be opened or foil removed from detector cells by an individual trained by the manufacturer and approved by the Radiation Safety Committee to service rad!onctive devices. 4. -The licensee will prepare labeled research drugs, dosages, and- formulations for use in clinical evaluations of a new drug. These materials are then transferred to a NRC license holder who has approval to use such drugs in clinical atudies. 5. The licensee shall not use material in or on human beings or applications where activity is released except as provided otherwise by specific conditions of this license (see Items 6-8). : - u1 ' O O r s : Item #6 - (continued) 6. Licensed material will be used for animal feeding studies or dosing into animals as labeled drug for absorption, distribution, metabolism, and excretion experiments in connection with pharmaceutical or toxicological investigations and certain in,n_ vitro analytical procedures. Licensed material is also used in the synthesis of radiolabeled pharmaceuticals or precursors. 7. Experimental animals administered licensed materials or their products , shall not be used for human consumption. 8. Occasionally low level radioactive tracer studies will be conducted in a segregated and well-defined (marked off) area in a greenhouse or outside field. These research and development studies will incorporate less than 14 3 a total of 100 uCi C or H 1abeled herbicide or insecticide (less than 20 uC1/ag specific activity) applied- typically to a plant directly on the leaves or' by injection. All of the affiliated solid and plant material will be monitored and recovered. -9. Individuals. involved in operations which utilize Hydrogen-3 in a non-contained form, shall have bioassays performed in accordance with the NRC 1976 draft of the Tritium Guide. 10. a. Excluding RIA kits, individuals using Iodine-125 or Iodine-131 will work in laboratory fume hoods suitable for radiochemical work. Persons working with these substances will conform to the provisions and regulations -in Iodine Guide 8.20. Animals used in the Iodine tracer I l -| , o m- . ' : , . ; ,ey . p k,. S' V .(j E ^ t ' ~:1 Id || | Item f6 - (continued) N r experiments will be housed in appropriate containment units. Air from these units will be suitably filtered.' !, b. Whole body- film badges and ring badges will be. worn' by all persons while working with radio 6ctive Iodine. , These will be changed monthly. Room air and working areas will be monitored with a beta / gamma [. detecting survey meter. A high efficiency (Type H) cartridge respirator approved for use with radionuclides shall be available in the room for emergency use. .. ) L ''. u- > . - ._ _ _ . , - _ . T * t " , .p Item #7 . Individual (s) Responsible for Radiation Safety Progr,tm .I i and Their Training and Experience ; ; I ! t t Radioactive materials will be used by or under the direct [ supervision of specified individuals approved by the Radiation Safety ! Committee (RSC).
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