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In Reply Rarer Tot ATOMIC ENERGY COMMISSION Faclosed is a copy of revised draft of the Tentetire k'inutes of Zmch 15, 1949 ltseting of Suboomittee on Eamaxi AppficEtiona of Committee on Xmtop6 Ciistrfbution of U. S. Atomic htsrgy Cods a ion, comments on the Tentativs Kinutea eu bm it ~ e dApril 29, 19-49, were This reviaion is oared upon You are requested t o submit a letter of approval o f this revised dr5ft as quiakly as poasikle so that the Isotopes Division cans 1. f>rspars tka airaulors descrribad in letter of April 26, 2, Send a fetter to the Atomic Energy Commission reoomsnding: a. Acceptance of Ur.He milt an ' s re rip ation and the appoirtb. Appointment of B. ohairman OF the 8ubaomruittee OP Eman Applicationrl Go ~ ~ e i - v efron! July 1, 1649, t o July 1, 19%.
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T U 8 ciroular may be irsued a s a'rsvision of lsotopee Division Ciroular E-SS, at oopy of'whioh is enclosed. A third oiraular all embrace t h e followinp: item in the minutes: Be r h a l l wlelooau your oommsnts on the tentative minutes.B Very truly youre, S. Allan Lough, Chief Oak Ridge Gpsrations
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GUifOl’ ITTEE: 0: HEPAR APPLICATIOE OF The Su1com3ttw on Human Applioations of the Abmic Energy Comnisaion Committee on Isotope Distribution convened a t Et30 a.m., March 13, 1949, in Roon E1S of the Atomic kaergy Comission Building, Nashington, D e C. a d S. Allan Lough rere present as representatives of the Ieotopes DiVf6iOn. The Suboommittse established the f ollow5ng a @ d P1 1. Review o f the minutes of the last mooting, hhroh 22, 23, 1948. 11. Ciatribution of irotopes for canaer researoh. 121. Cisoursion o f specific items pointed out by Dr. bdoodruff in his letter of February b , 1545. A. Policy regard iq field and industrial uses of long- ’bo Revim of policy relative to a.l.loGations on supplementary 1. Cases in whioh t h e quantities requested have been materially increaeed for the same purpose. 2. Caees in which the original allooation does not conform uith the latest reviaed policies.
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C. Rsriet, of' action taken on a p ~ lica tio nfor human UBO of rabialron and f ' Or mdl a ~ i 5 nof B po1:cg for future b e permitted in products snd items sold 'tu t h e pu'itlLfI. vision of patients rsaaivtng rudi a i a a to pes throuph Atomic kcurey kmrdra:on f ' a ail it i as. Attention waE foauscd on this Lo ferry PaCulZagh ed St to Glaoeer in Cleveland Clinio iZvartrrly 16 I 1.7, 1MS. The titatmzent read "So Xeithar hospitalization mr supervision of the patLent it required rrd the c o s t of treatment is les8 thRn that of thyroidectomy or prolonged
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A. Conrideratiod of u r e of radiolsotopsr in tfaoer studio3 in nowal adult humns. g#nua amittere with a biolofiiaal half - life of 20 days ar less, There ramarks are for general cuidanae but the Suboomndttee on Haman Apilioations will examine sa& orrw on It6 own merits. The following renarks apply to beta and Appliornts who deeire to use radioirctopee in noms1 adults should rubnit the rerultr o f animal rxparimentr, or adequate refersnoer to the literaturo, oonoarning the following point., 1. Metabolim and distribution ef the radioaraterial in the The tirsue of highest ooacentratfon rad the relative2. oaoe ntration there in. 3. The relative ooncentrations in the tissue of interest land parti auk rly radiosensitive tissues suuh 8 s the goaled8 4. The biological half-life of' the raaioisotope in the tissue of highest conoentratian, the tiaaue of interest and the partioularly radiocensitive tissues. All trnaer studies in normal humans muet be approved by the b o a 1 IQsbioisotopes Cornnittee before eonsideration o f the Applieation will be &e by the Subeonxiittee on Ruaen ,Applfoationr. The above rtrtaments apply to both Atomio Energy Commirsion and other installations. 5 . Applieationo for use of radioisotopes in normel ohfldrsn will be given special scrutiny Sy the Suboomittee on Buman Appli -
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greater than 2 0 Caps, the dosape in the aritiocll t i ~ s r u e r ahould Le such as t o oonfom, tothe limitations 6taterd by the Retioral Cannittee on Radiation Proteation* In ape oi alca ees, nowever, the Subcamittee on fiunmui Application8 wy pam it the use of radioisotopes in The Suboommittse on Emm Applioations feels that each requost for use of8 Ion&-lived radioisotope in human 6ub33ata must be reviewed separately. In the ninutes of the initial meeting of the 3.nt;eri.m Advisory Committee on lootape Dirttibution Poliay, held June 28, 1946, a t Oak Bidp, the following statement appears on page 9. even though the scarcity of C 14 is P *jar faotcr to be eonsidered, the UBG of t h i s materiel in.u human being should not uc sanctioned until its absorption ernd elimination properties is; clearly demonstrated in animsls. The very lone half - life of the ltatarial The Opinion ma generally expressed that, The Sub od tte s on Buraan Applloations frsels that, in vim of reoently acouaulated information, it i s prepared t o aoneidsr applioations for UBC) of asrtain C 14 oompounds papers were oonskdered : In arriving a t tbis coaclusion, the folloui2lp;
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"The ?%to of C 14 in the Tireuot of Mies nfter By borge L. lardi, M. D., b dirt fon Lrrborrtory m d Division of )isdim1 Phpie8, University of Cllifornia, herkaley, California. Letter from John E. Lawrenee, Domer Laboratory, University of California, February 18, 1B49, whiah roocunpanisd tlardi.8 paper, listed a6 nan, abme. "Report on Estimated Iiore~Dolivorea to Organe of Giri. Thir report i6 bamd on Hardi'r paper, listed "Studies on the Hazard lavolved in Use of Carbon 14. 2 . Retention of Carbon fPom Labeled Sodium Biorrbonate'. TBCHTICAL REPORT 6ro. 1 to Offloe Saisnaea Md sion)utd At da bnergy Ckmdsrion, Dlvi6ion of biology m d Yediohcr. Wom-885, Task Order 11, I?R 171642. Southern of tritium t o Dr. John Lsurenoa. %is state ~ ~ e n twill be prepaled and sent out under separete cover. (Dispatahd to the Subcommittee on Hurnan Applicretions on &:arch 25, 19#b.) It is reoognized that there m y D e instances in which the disease fromI). which a patiant is sufferis~gpennits the adrciriiatration of hrger doses for be given tpeoial oonsidoratlon by t h e SuboamAtteo providingr. #pplioutionnr for suah use8 of radiofrotopas will 1. Full responsibility for bonduct of the work $6 assumd by 8 Special oonnniftee of at lehst three oompetsnt phyricians l a the institutior in which the work is t o be done. This w i l l no2 necessarily be the looal Radioisotope Cornittee.
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2. The subject ha8 pi w n his oonrent t o the procedure. 3. There i s no reoaornable likelihood of' produoing mmnifest injury by the radioisotope t o 0 8 employed. 11. Distribution of isotopes for canoer researoh. 8 . Cancer researoh is interpreted to inolude the fol la ring t 1. lnvsctigation of the basio aspects of normal and The development and evaluation of therapeutic M d2. di agn or tio prooedures for oaaoer &nil allied diseases. 6. The Subooaanittecs on Human Applioations arpressee aonfidenoe in the w8y the Isotopes Division i s handling t h e allocation of Iodine 131, Phosphorus 52 and Sodim 24 for use iE dia-osis, therapy and rerearoh in cancer and allied disea8es. The uae of Cobslt 60 needles is not considered research by the Subcornittee on Human Applioations unless the needles are of s o m unusual deaign or incorporate some unusual feature. Ths lktional Canoer l not it ute has standards for determining those to whom radiua, neaCles might be lent. The isoto'pss Division w ~ k 6 asked too ota in these standards end to 8end them to the Subcommittee. The 8uboonm;ittee will then recommend a way to oontml fhe distribution of Cobalt 60 needles. 111. Dirousrion of' rspecifio ttcu9s pointed out by Dr. hoodruff in his letter of February €i,l$#B. A, Polioy regarding f i e l d and industrial uses of loq?-liYard
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~ b aYuboo~nmittoe n opinion i; that eonrideration of requertr for field nnC indurtrial uno8 of radioisotope6 ir primarily one of safety aontrol aeoountability. Illustrative situations were reviared Reclanation, Great falls, Yont.m. aonsidered nil, but this application was rejected beoruse S S5 i n the underground firinc of oaal mines. UBtitUt4 wae eonridered rafa under the conditions outlined. Yttrium 90 $.n n bulat ed plane crashes. (Request No. 2863). Tho Bational Advisory Cormittee on Aeronautfoe' proposal t o use Y 90 stearate in labeling p;esolfne in rsimulated plane orasher was aonsidered acoeptable, pro ~ din gthe work mould be done iS en area sufficiently remote from human kLaLt)i*tioR. The proposal to oanduot this work on the Cleveland Airport The UIO of Cobalt 60 for rtandardr (100 pw -ah) to ealibrets Also Request No. 2373, Thin proposal by the 8outherc Reoaarah The Suba witte e on H m Appliaationr felt that the UBU of Cobalt 60 in amounts of t h e order of 100 mo for standardization. of inetruments io reasona'S1e. If and when the Armed Services
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mako suah requs8ts, 5 way rhould be found to provide the riandards but without relaxation ot' eaf e ty rules. D . Review of policy relative t o alloaations on rupplsmentary requests for use i n humn .UbjeOtS~ 1. When greatly inor8aaeci amounts art! requested for the lame purpom, am indiarted on an earlier request, the decision us t o whether the applicatioc can to approvod will rhould be jur tif i ed by; e ) A ao8~aansurateinorerre in patient load. b) An expendsd researah program. o ) Provision of sdequate storage and handling f'~cilitie8. are adequate for the larger amounts requested. 2, If the rupplamentary application inaludes a propoosl vhiah ~6 formerly rocepi%blc, b u t now conflicts with revised poliaies, it xi11 not be approved, will be tarked to revise his applioation to make it oonfom with aurrant polioies. Thi ~applioation will than b e suumitted to the Subcontliittee on Eumra Applications f o r review and C. Review of oction taken on rppliaations for human us% of radioiron and formulation of B policy for future guidanes. of iron i n the organha and t o sand a statement on this matter t o the a.1II'Der~of the Subcomaittee on Buman Applications for t h o t r 1.186 in
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making oaloulations. Tha Suboonmittw would then f'ormulata a polioy with regard t o olleoation of iron for human use. D. Disausrioa of polfay on level of a otl vit y that mifht bo 1. Bnitters of beta particles, Proporals to inoorporats teta emitting rudiofsotopes i n produotr offered for role aan LS approved if(1) the a ot iv it y is in lnroluble form and ineorporated pcarmansr&ly in inert auterikl, and ( 2 ) the product produces no more radiation *a 0.3 r8pfrk a t the i n the field to deteneiae the rctuolbrokground of rsdioaotivity i n industrial mterirls. * Produut6 oontaining gasma amltters must meet the conhitiom outlined above f o r beta emitters. In addition, when products are store U in warehouaes, monitoring muat bm done t o ahor that the radiation level ibin accord uith the regulation6 rstatea fnths handoook on Safe fiandftng of Radioirotapes is6usd by the bfrtionol Committee on E. Clarifioatiou of poliey on borpitalitrtion and rupervisioc of patients reosivine rr dio i rob pas through Atomie Energy Cona?isrion
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Dr, C rih tr rtaterasnt i n the art iole tef6278d t o was d ii eur sed. The Subomnittee okjectad tothe phrars "no supervirion'. felt thot patients could appropriately be treated with radfoaotive iodine without hoopltalizntion but that it mas an overrtatement to ray that they d i d not require ruprvision. There was some okjeotion to Dr. Crilt'c statement that the oost of trcrob-elit with radioiodine i6 lorsr than it should be, if o o s t oE produotionwere ineluded. was pointed out that the ooet hrs beer, established by oonsidering the radioiodine as a bypraduat of pile operation and that on tOi8 ba8i11 th6 prioe pny not be out of line. Dr. Friedell felt t h 6 t the present ptiee i s artificial and after all, the pries eonrldrred by Dr. Crile isthe prioa now. F. Use of r8dibi8vtOpaW in preglaanoy and in n o m 1 ohildren. use of radioactive miterials ir. all nom1 pregnanaies rhould be strongly discouraged wbre no thetapuetic benefit is to be derivea. f a pncaral the use of raU io iso to pr in normal ehildren should be di800uragsdl ifowever, the Sub ood t tae rill eonrider proposals for u8e in b pork st rosearehbr, provided the problem ou u rot be stu did properly by other methods and provided the radiation domap level i n any t5srua i o low enough t o be oonsidered hm-tnlest. It
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rhould be nQtbd that i n general the wunt of radioaotive mtorial per kilogram of body weight murt be mnnller i n ohildr.ezi than tbt required for similar rtudiee i n tho The Subamnuittee reviewed the violation of the “Acooptaaas Terms“ Dr. Eenrtquer used Iodine 151 on hrnarxl sub3aatr in studying the bshwior of X r i a - K O 0.1. After ttudy of the eituation, the Subo ~ u mitte sreoommended that a stroly: letter be sent t o Tracerlab, type of violation rill reoult fn atappiq. shipments of radiaaotive mterlrlr t o Tracrarlab, hoorporated, and a thorough review of the entire s it w tion by the highest authority in the Atomic hergy Coaaf8rion. Suah a letter wu8 sent to Traosrlab, bo. on April 11, 1345. Attachad to the as pinutem nre (1) a copy of letter dated April 11, 1945, dated April 14, 1949, from Rill i81p E. barbour, Jr., t o Paul C. kebersold, and (3)a oopy of aemorandum h ted April 14, 194b,kom fi ill i run E. tiarbour, Jr., t o eeleoted members of the staff of Traosrlsb, Lnu. The letter sbould etate that a recurre1106 of this 8. aopy of letter V. Review of r pac if io applioations not yet rated upon by this earclnoma. This application had been approTed earlier on favorable
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. doairion by three memberr of the Suboammitue, Dr. Rie dell WPBS ooncerned boaus eobjootiea. might be too widely dirsemin*ted if used on filter paper plai;Uet* Gladp J. Fashem, for use in blood volume s t u d y in ohildren. Doorge proposed is from oae-fourth to one miaroaurie Phosphorur 32 per k i l o - This applioation was approved on February 14, 1949, after the No responae hmd been reosived from Dr. Frledsllr In response to a letter from 8 , A, Lou& dated January 26, 1946, t o the members of the Suboom.ittee on Ifwmn Applications, Dt. Puiniby for isotope allotaunt. This morning your letter arrived ooncerring application 2661 for the use of P 52 in blood volume studies.Z had …
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