Document 3Ej9BOY3XOBYk6Rw8xrxQERE

FOwJ DRUG A3** * ^5 iRAT EON KQvesbar 30, 1971 WUECTi lead lased Paint ftinXCNCE: 21 CHI face 191, Tidtnl h|licir November 2, 1971 Tha American Academy of Pediatries fUaa the following consents on eho aattar c laaua tad now undar conaldaraEloa: a a 1c la roeocnandad that Cha Toad and Drug Administration promulgate a final sogulatlon partalnlng to tba load content in painta and that fiha limit for load bo raviaad downward froa tha propoaad .11 to "minimum traces" or <0.06Z of tho total weight of the contained aollda (ineluding pigaant, flla aollda and drlara). This raeeaaondation is baaod on tba study of raeantly published materials!*2****, baaad upon an avaluation of data publlahad aftar tha 11 voluntary standard for load was originally ostahllshad in 1933 by tha Aaariean 'atlonal Seandarda Inatltuts. Tho Aaariean Acadoay of 9adiatries roeouaaada that palnto containing aora than ainiaua traeas of load ba daelarad bannad haaardous substances, if Intendad for use on children* a toys, furniture, or interior surfaeaa. Open review and evaluation of available data in children and adulta, an Ad loc Conaittee (1. G. King, Chairman)* raeantly concluded that for children e the aaxinua dally permissible intake (DPI) of lead fros all aoureea should not axcaad 300 jig Pb/day.* If svarsge daily intake is maintained below this *Thls DPI is concerned primarily with increments in oral intake of inorganic lead salts. In calculating ehia DPI, it was aasuaed that average daily respiratory exposure in moat urban areas la approximately 2 ug nfm*. Any significant Increase in respiratory intaka would have to ba given added, weight because respiratory retention la eatlasted at 33-40Z of vary small lead-bearing particulates in the lower respiratory tract. Assimilation in he Cl traet la eatinatad at 3-10* of oral intake. It is understood that the comments which follow apply almost exclusively to increments in oral intake in tha praeanee of constane but low levels of respirstory exposure (2 jig Pb/n3 oh the average). 0007-8MP--037089 N22927 Ah>w*| >*c co c*ccc %3 f3/ whole bleed. At this level of intake, it is csclattcd thst the sssunc asslullstad by o m to three year old children could probably be excreted,' .* '"* that no net increoenc in total body lead burden vould be anticipated. It la estinated that approximately one-half of this 300 yt Pb/day intake .mould be derived iron usual food, water and sir, eo that intake fron all *o that eourcee on the average should not exceed 130 jig Fb/dey. In parti cular, average daily ineekee below this DPI vould not be associated with a any significant incxaaent in soft tissue lead content. It is this portion ~mf the total bvdy lead burden which appears to bo roeponaiblo for the known toxic effacta of lead. a *' `Available data indicate that increments in total load intake above this 'DPI increase assiailsclen (sea Chapter 3 in tsferenco 2} and raiaa blood levels above 40 yg Pb/100 C vhola bleed. Such lncrenenta nay bo soaocieced -with increaae to the soft tlaauo cooponent of the total body lead burden. ---Ac-blood lead concentrations of 40 to 50 yg Pb/100 C whole blood, -seas --individuals cay show ninioal adverse aacabolie roaponao in the fora of *Socressed dolta-aainolev*ulinic aetd (ALA) exeraelon in urine (sea rafaranca lb'. 2, Chapter 4). Increased ALA excretion in urine' in the aetabolle response nost specifically aaaoeiatnd with rising conenntratlons of lead in s the soft eisauoa. Xncroaanea in total aeslnilaclon of load eo levels five fold eo tenfold above chat aasiallatad froa usual dietary ineaka, if eon- tlnued for several waake or aonthe, clearly can bring such persona into the range of adverse aetabolle effects and can be statistically correlated with blood leod* levels in tbe rengo of 40-10 "ug Pb/100 C whole blood. Xn soae instances, persona with blood load concentrations in this range aay show o non-specific syaptbna compatible with, hut nee diagnostic of, clinical 0007--SUP-037090 -3pluablsa. Ac blood load concentrations of 60 pg Pb/100 6 whola blood or hi|bort x-ray evidence of obaonal skeletal ainarallsaelox at cha coda of growing loag booaa oeeura to mm children whoa excessive intake persists for aovoral vaaka or nonths or loogar. Such uodaalrabla affaeca ahould bo avoidad to young growing ehlldrta. It ia eoacludad, therefore, to preserve haalch, pravaot adverse netsbolle affaeca attributable to toeraaaad aofc tlaaua load coacaat to growtag cMldran aad eo olatolao the rlek of aacloua polaoatog, tha total dally totaka of load ahould bo Halted to C300 jpg Pb/day. A volley acataaaae roeaatly approved by tha lurgaoa Central of tha 11. t. Public fealeh Sarvleo atallarly eoacludad that blood load eoaeaatracloaa >40 jpg Pb/104 whole blood bo eoaeldorad ladleatlvo of undue oxpoaura to load aad chat children with blood load coacaatrattoao to the 30-60 jpg Pb/100 C bhola blood range he eoaeldered ae ooaalbla eeeee of lead tatoxleaploa aad that auek childrin require further andleal evaluation.* in view of tha prevnlaace of plea to ana to three year old children* the femlaelble content of lead to petal ahould bo eoaeldorad with the foregoing to wind. The content of lead to paint ealculatad aa eleaantal lead end enpreaead ae a percent of the total weight of the paint nay be a good criterion by lndoitry for the coacaat of lead to paint par ae. lowever, thla la not a good criterion for evaluattal the health hanard praaeat la ehlpa of paint free earface eovertaga of the walla, windowe, doors, fumlturo* aad other object* to which children nay be exposed. It ie the weight of lead to the chip* that doternlnee tha health hasard. locont studio*9 indicate that tha weight of aultllayar paint chipe can be related to the nuubar of layers of paint applied to a surface. In this way, the aaouat of lead in single aad nultlple layers 0D07-SWP-037Q91  4* of paint ean ba calculated Iron tha percentage of laad contained in tha paint, Such calculations arc shown In Table 1. For axaapla, etudlaa at tha U.S.P.M.S. Injury Control laboratory, Providence, *.I.5 indteata chat 1 s', as. of one layer of interior paint nay weigh 5.2-6.0 ng (avg, 6.3 sg) and that sin layers of paint nay weigh 37.0-40.6 ng (avg. 31.6}. Sixtynine staples of aultliayer paint chips obtained fron old dwellings in Philadelphia wars found to woigh 1W3 ng par sg. cn. of exposed surface. (Tha tarn "eg. ca. at exposed surface" in used hare because of the difficulty in stapling a precise and reproducible voluae of paint under field conditions}, fatty ng of interior paint (6 layers} containing IX of lead in the final dried solids would contain 400 jig Fb. Using the sane calculation, a 10-layered paint 'surface containing IX lead night contain 660 yg Fb/ag. cn. of exposed surface. The calculated dose in either instance is in excess of the calculated Oft (daily permissible intake). One sg. cn. of 6 ulayers of paint on a surface containing 0.1X laad would contain 40 yg fb; vhegeae at 0.05X lead, 1 sg. cn. at a d-leyerad surface would contain 20 yg fb. In thin last instance, ingestion of a paint chip with 1 eg. cn. (6.25 ca*) of exposed surface per day on the average can he calculated te provide a dose of 125 yg fb. Thus, 125 yg of load fron feint, tognthnr with an allowance of 150 yg at lead fron tbo usual ltad contest of food, wstor, and air approaches tha SfT of 100 yg fb fron ell sourest but would noko llttlu allowance for auch ether non-dietary sources ss the child nay encounter**. Also to ba coasldorod Is tho pravaloaco at pies in young ehildrna. It Is estlnetod that approximately SOX of childrao betwoan ono end thraa years at age repetitively iogest son-food substances. Abdeainsl x-raye obtained In the diagnostic evaluation at children suspected at having land poisoning in dicate that very large quantities at foreign eubetenena sueh an peine, putty, 0007-8NP-037092 0007-SWP-0001 -3and plaster oay be ingested, often without tho paranta' evarenaaf. A federal itmdiri far laad to ^0.06} ia needed la ordar eo ainlaiaa this particular health hasard to futura generations of children. At tha praaant tine, laad poisoning aa aaaa in children ia related to eld, deterieratad hearing ao that a federal atandard la unlikely to hava a algalfleant lapact on pluablaa aa new aaaa. Mavarthaloae, aa thia old houalng ia replaced or rehabilitated, eafe aurfaco eovarlag ahould ha uaad ia order to ainlaiaa haaarda to tha health of futura childraa. Becauae plea hae boon a uellracogaltad habit aaong huaaaa for neap concurlaa. It appaara unlikely that thle behavioral pattern will quickly change. The Anerlcan Acadaey of Pediatries endoraaa tha prlnclpla centalaad la tha o netitioB filed with tha Coanieaioaar chat palate containing aara than nlauto tracer of laad be declared aa banned hasardoua aubataneaa, if intended for one on chlldraq'a produeta or Interior aurfacoa. It appoare that cautionary label ing will not adequately protect tha public health and aafey. It ohoold be further noted that therapy la not affective la, reversing or preventing paraanent brain daaega aeeoclatad with aevare feme of acuta load polaonlng euch aa acuta encephalopathy. It la currently aetiaated that AOS or noro aurvlvore of aacaphalopathy auatala permanent brain danage. Zn order to provide a margin of aafety against such occurrences, which are not reversible by currant nethode of chelation therapy, it ia aeaent'lal that the level of exposure bo reduced. Promulgation of a federal a* atandard with raapaet ta laad to minima traces and certainly to ^[O.Odl .b probably would provide a safety fseter of five with raspoet to dotea unequivocally associated with demonstrable adverse metabolic responses in 0007-SOT-037093 0007-SWP-0001 virtually all individual* and clinical toxicity in mb *. Except In iaseanee* of voracious pica for paint, it would probably provide a safety factor of at leapt 20 vitb respect to the average dally Intake, idiich 1* probably eeesssary to caoaa encephalopathy and fatalitiea In children. Such a safety faeter would appear to bo a ainlaua requirement.. m 0007"8MPta037094 imuncss 1. Ua. I. 6.1 Kaxlaua telly Intake of lead without exeatlive toi) lead-butdan la children. tan. J. Bit. Child. 123:317, tin. ** 3. Alrborat tud la hripKtiw, repote of Counitree oa Biologic Iffeeta of Ataoaphorlc follutaott of tbo Blvlaloa of Nodleol Sciences, to bo gabllohod by the Kaeloaal Boaotreh Cowell, Bacloaal teodaoy of Sclancet, ttaahlogtoa, D.C., 1171. 3. Chlaolo, J. j., Jr.i Zncretaed load absorptions Toxicological coatldorttioaa. Centtnttry la Podlatrlct 1971. 4. Kodlcal oapocco of childhood load poisoning; Stacoaoae approved by outgoes ganoral, D.l.7.1.1. Podlacrlco *1414. 1971. 5. Blog, 1. B.t fartonal Coanualestloo g. Boot, V. r., Jr., flakarton, C., McBulty, 0. and Croateo, J.7.t The 77 ald-vastcra city atudyi A ttvdy of tract tlaaaot pel* lotion of the air. frataatad aft foarfth Annual Conference on Tract febataoeca, Uaivoxaifty of Mleaowri, Columbia, Klaaourl, Jaat 33-24, 1970. -70007-IJWP-037095 TABLE 1 Amount of Load in Single and Multiple Layers of Paint ve. Par Cant Lead Content in Paint Painted Surface Covering Calculated Lead Contest of Paint Chip With 1 cm. * of Enpoaed Surface No. Lavara Bounded Average Wgt. of Paint Chipt fMllIiarasna) Par Cent By Weight -Amount IMlcrerrarr.fi 1 4,5 mg 4 40,0 mg 1.0% 1.0% 45 pg Ph 4O0|sgPb 10 .(5.0 mg 1.0% 450 jag Fb 1 4.5 mg 4 40.0 mg *0 45,0 mg 0.1% 0.1% 0.1% 4,5 pg Pb 40,,0|tgPb 45. Opg Pb . 1 4.5 mg 0.05% 4 40.0 mg 0.05% .w 45.0 mg 0.05% tsame area} o. g. . 1 eg. cm. of 1, 4 and 10 layera of paint. 1.1 pg Pb 10.Opg Pb SS.OpgPb 0007--BNP-037096