Document 2jkLp6jVB5XQRGLa7G7EZbXxR

T0Z3 DRUG A3::i:;lST8ATtOS gQvesbar 30, 1971 ' SUBJECT! laid lassd Taint BIFEXESCE: 21 CFB Parc 191, Federal Rtglaear Vovasbar 2, 1971 Tha American Acadcsy ef Pediatries fllaa the following consents on tha aattar at iaaua aad now undar eenaldaraeloa: a * It la raeocnandad ehat tha Teed and Drug Administration pronulgats a final ragulatlon partalnlng to tha laad contant In painta and ehat tha Halt for load ba ravlaad downward fron tha propoaad .3X to "nlninun traces" or <0.06Z of tha total walght of tha contained aollda (Ineluding plgaant, flln aollda and drlara). This rscoaoendstlon la baaad on tha study of racantly publlahad materials1*2*3*4, baaad upon an avaluation of data publlahad aftar tha IE voluntary atandard for load vaa originally oatabllahad In 1933 by tha Aaarlean 'National Standarda Xnatltuta. Tha Anarlcan Acadany of fadlatrlea roeouaaada that palnta containing aora than nlnlnun traeaa of laad ba daclarod bannad hatardoua aubatancaa, if Intendad tor usa on children's toya, furniture, or interior ourfaeaa. Open ravlaw and evaluation of available data In children and adulta, an Ad loc Cooaittee (1. 6. King, Chalrnan)1 racantly concluded that for children a tha waxiatua dally permissible Intake (DPI) of laad fron all aourcaa ahould not excaad 300 jig Pb/dey.* Zf avarage daily intake la nalntalnad below thla *Thla DPI la concarnad priaarlly with Incrananta In oral Intake of inorganic lead aalta. In calculating thla DPI, It uaa Beamed that average daily respiratory exposure in neat urban areas la approxlnataly 2 ug n/aV Any significant increase In respiratory intake would hava to ba given added, weight because respiratory retention la oatlastad at 33-40Z of vary snail laad-boaring particulates in tha lower respiratory tract. Asalnilatlon in he Cl traec la eaticatad at 3-10X of oral Intaka. It la understood that thi consents which follow apply alaost exclusively to ineranants in oral intaka in tha praaonca of constant but low lovels of respiratory exposure (2 jig Pb/m3 oA tha average). * 0007-8WP-037089 N22927 4hlW4| M >*< i kC Ur.,4hC*^ CO C*CCC ^ g whole blood. At this level of Intake, it la catlotted that the asount asslallated by ana to thxee year old children could probably be excreted,- V , . '. ``no that no not inereoenc la total body lead burden vould be anticipated. Xt la aatlaatad that approximately one-half of Chit 300^>g ?b/day Intake , would be derived froa uaual food, water and alr( aa that Intake froa ell *a other sources on the average ahould not exceed ISO jig rb/day. In parti cular, averaga daily intahaa below thia on mold cot be aeaoelated with .o any algnlflcant lnerennt In soft tiaaua lead contant. Xt la tbla portion --of tho total body lead burden which appaara-to ba raaponalble for cho known toxic effects of load. . a - * a . * .' . `Available dete Indicate that Increrenta in total lead Intake above thia 'ttl Increase oealalleelen (aee Chapter 3 In inference 2} end relee blood . levels above 40 jig fb/100 C whole blood. Such Inc Tenants nay be aeaocXaced -with increase la tbs soft tissue couponont of the total body load burden. --At-blood load coneantratlana of 40 to SO jig Fb/100 C whole blood, -sous --Individuals nay show alninal advsrao natabolic roaponao In the fora of Sacroasod dalta-aninolsv*ullnlc acid (ALA) oxerotlon in urlna (aao refaranca Mol 2, Chapter 4). loeroaaod ALA oxerotlon In urlns' in the aetabolle rosponoo aoat specifically associated wish rising concentrations of lead in tho soft tissues. Xncreaenta la tetal aaalailaclon of lead to levels five fold e tenfold shove that otalallstod froa usual dietary intake, if con tinued for several weeks or months, clearly can bring such persona into the range of adverse natabolic effects and can be statistically correlated uieh Used leada levels in the range of 40-10 jsg Fb/100 C whole blood. In sene instances, persona vitb bleed load concentrations in thia range nay show o non-specific syaptbas compatible with, but not diagnostic of, clinical 0007--SUP-037090 3pluablam. Ac blood load concentricIona of bO pg Pb/100 C whola blood or higher, x-ray evidence of ebaoraal akalocal inerallsatloa ac cha anda of growing long bonoa occurs In sons children whan axeaaaiva intake persists for aovoral waaka or aoneha or longer. Such uadoairabla affaeca ahould bo avoided in young growing children. It la concluded, therefore, to yraaerva health, yravant advaraa oatahollc effaces attrlbutabls to ineraaaad soft tissue load content in grow ing children and to ininlse the risk of sarloua poisoning, the total dally intake of land should bo United to CJOO pg fb/day. A policy stataesne recently approved by the burgeon General of the V. I. Public faalch Service ainllarly concluded that blood land concentrations >40 jpg Pb/100 whole blood be considered indicative of undue axpoaura to load and that children with blood load concentrations in tiis 30-10 pg Pb/100 0 whola blood range be considered as noaslbln eases of load Intoxication and that aueh children require further nadlcal evaluation.* In view nf tha pravnlonca of pica in nna to thrao poor old children, the pamiaalbla content nf land In paint ahould ho considered with cha farogalag in Bind. Tho contone af lead in paint calculated aa elaaantal lead and anpraaaad aa a percent af cha total wight of tho paint nay ha a good criterion hy Indus try for tho content of load in paint par aa. lowevar, thin is not a good criterion for evaluating tha health haiard praaaat la chips af palae fron aarfaca coverings af tho calls, window, doors, furniture, and ether objects to which children nay ha axpesad. It la the wight af load in cha chip* that datsrnlaaa tha health hasard. laeant studies9 indicate that tha wight of aultilayar paint chips can ba ralatad to tha aunbar af layers nf paint applied ta a aurfaca. la this wy, tha anauat nf land in single and aultlple layers 0007-SWP-037091 0007-SWP-000118390 ' -4- of taint cin be calculated free the percentage ef lead contained In the paint. Such celeulet lone ere ehewn in Table 1. Tor example, etudlee et the U.S.P.N.S. Injury Control laboratory, Providence, K.l.5 Indicate that 1 eg. cw. at one layer of interior palne nay weigh 5.2-g.O ng (avg. (.3 ng) end that aln layer* el feint say weigh 37.0-40.6 ng (avg. 3B.I). Sixty- nine eeapiec of nultllayer paint chip* obtained froa old dwelllnge in Philadelphia were found to weigh 49+33 eg per eg. cn. of expoeed eurfaee. (The tern "eg. en. at expoeed eurfaee" te weed here botauae of tho difficulty In eonpllng a praeiaa and raproduelble voluoe of paint under field condltlona}. Party ng of interior paint (6 layare) containing IS of lead la the final deled eelIda would contain 400 jig Fb. Ualag the cane calculation, a 10-layered paint 'aurface containing IS lead wight contain 690 yg Pb/ag. cw. of expoeed eurfaee. The calculated doae In either lnataoca lo in exceee of the calculated DPI (dally perwlaeible intaka). One ag. cw. of 6 layare of paint on a eurfaee e containing 0.1S lead would contain 40 yg Pbi whegeae at 0.05S lead, 1 eg. cm. of a d-layered eurfaee would contain 20 yg Pb. In thin lnae leotaace, logoutIon at a point chip with 1 eg. cw. (6.25 cw*) of expoeed aurface per day on the average can be calculated to provide a doae of 129 yg Pb. Thua, 125 yg of lead free paint, together with nn allowanca of ISO yg of lead froa the ueoal leal content of food, water, and air epproechee the OPT of 100 yg Pb froo all ooureoa but would wake little allowance for each other non-dietary eoureee aa the child way encounter**. . Aleo to be coneidored le the prevalence of pica in young children. It 1* entiaated that approximately SOS of children between one and three yearn of age repetitively iagoat non-food eubetancee. Abdoainel x-raye obtained in tho dlagnoetlc evaluation at children euepected of having lead poieoning in dicate that very large guantltloa at foreign aubetancea oueh aa paint, putty, 0007--SMP--037092 0007-SWP-000118391 3 nd plaster My be ingested, often without tha parents' avaranaaa. A fadaral standard far load to ^O.OU la noodad In ardar to niniulas thia particular haalth hasard to futura ganaratlons ef chlldran. At tha praoant tiM( land poisoning as assn in ehildran is ralatad to old. datarioratad housing so that a fadaral standard la unlikely to hava a significant lapact on plunblsn as now aaaa. Ravarthaloaa, as this old housing is raplscod or rehabilitated, safa surface covering should be used la order to lalnlse hssards to tha haalth of futura children. Because pica has bean a wall* recognised habit aaong hunans for May centuries, it appears unlikely ehae this behavioral pattern will quickly change. Tha taerlcan Acadacy of Pediatries andoraoa tha prlncipla contalnad la tha Mtitlon filed with tha CoonisaloMr chat paints contsining aora than ninuta traces of load be declared as banned hasardous substances, if intended for use an children's products or interior surfaces. Xt appears that cautionary label* lug will not adequately protact tha public haalth and safey. It should be further noted that therapy Is not affective in,reversing or preventing petMnent brain dsaaga associated with severe fens ef acuta lMd poisoning such as acute encephalopathy. Xt is currently astiMted that 4OX or nora survivors of encephalopathy sustain perMnent brain daMgc. Xn order to provide a nsrgln of safety' against such occurrences, nhieb arc not reversible by current nthods of chelation therapy, it la essential that the level of enpesure he roducad. Promulgation of a federal o* standard with respect to lead to lnlaua traces and certainly to ^0.06X .b probably would provide a safety factor of five with respect to doses unequivocally aasoelated with denonstrahle adverse Mtabolic responses in * . ' 0007-SUP-037093 0007-SWP-000118392  mb virtually 11 individual* and clinical toxicity in c o b*. Except in instances of voracious pica for paint, it would probably provide a safety faetor of at least 20 with respect to the average daily intake, which Is probably necessary to cause encephalopathy and fatalities in children. Such a safety faetor would appear to be e ainiaua requirement.. l * 0007-SWEta037094 0007-SWP-000118393 amumcis 1. Uag C. i Kaalaua 4iU; lacaka of load without ueuilvi Ml lM4*larin la chlldraa. tear. J. Me. Child. 111:317. UU. 2. Airborne Laid la ririfKdH, repore of Coaalccae m Biologic gffecta of Ataoapharlc Vollutaata of cha Nolilm of Medical Science*, Co ha yubllahad by cha Naeleaal Kaaaarch Council, Rational Acodaay of Sclancaa, Uaahiogtoa. D.C., 1171. 9. Chlaola, J. J., Jr.i lacreaaad load absorption: Toxicological coaaldaratioaa. Coaaeacary la Padiaerlcc KiMli 1971. 4. Hadleal aayacca of childhood load pelcoaSng} Btacaaaae approved by aurgoea gaaaral. 0.1.7.1.S. fadlocrlca 1971. 5. King. B. fi.i Paraonal Cn--nnlection d. Bant. V. Jr.i Plakorcan. C.t HcBulty, 0. and Croaaoa. J.P.: . Tbo 77 ald-vectera city nudyi A anidy of craca cloacae pal* latlaa ef cha air. fraaaatad at Taorch Aanual Coafarance oa Trace Subatancaa. University of Kloaourl, Colaahla. N&caovrl, Jana 29-24, 1970. -70007H3WP-03709S 0007-SWP-000118394 TA8LE1 Amount ifLadia tin|l ud Multiple Layer* of Pelat va. Per Cent Lead Content in Paint Painted Surface Covering Calculated Lead Contest of Paint CUp With 1 cm.1 of Saqpoaed Surface - No. Lavara Hounded Average Wgt. of Paint Chipt ' fMIllicramal * Par Cent hr Weight --Amount fMlcrogratr.il 1 4.5 mg 4 40.0 mg 10 -45.0 mg 1.0ft 1.0* 1.0ft 45 pg Ph 400 pg Pb 450 |ig Fb 1* a *0 4.5 mg 40.0 mg 45.0 mg 0.1ft 0.1ft 0.1ft 4.5 pg Pb 40,,0pg Pb 45.0 pg Pb . i 4.5 mg A. 05ft S 40.0 mg . 0.05ft . w 45.0 ms 0.05ft n tSame area: e.g.. 1 eg. cm. of 1. 4 and 10 layera of paint. S.X pg Pb ao.opg pb 32.0 pg Pb -a- 0007-SINP-037096 0007-SWP-000118395