Document 3LaV8Jbw1R4bk1Qp3JworxRn

IOKM 137 PlihllU IM U.S.A. 3/70 FROV i. E. Ptftera Cleveland. 03D ANSWERING LETTER OF O- DATE y1 SUBJECT FKDEKAI, H.\2 ^aWU^UF.STAWCE' ____ IMint March 16, 1972 FOR W. D. Klnsnll, UCB ce: G. t. Bechtel, 1X3 H. J. Rorton, OQB Xft, J. Kiefer, UCB \jC Pi long, UCB T. J. W*l*h, UCB C. U. Wright, UCB . i' Attached it copy of the now FDA regulations covering paint containing lead. yho flrr.t of the ntttclmant contain mtreelliu'eoi;* background reiterating the iKviltloni ol group# which wort supporting end fighting thn regulation. Ce-wr.slnjj ct the bottom of page 9 lt Article 191,9, tho regulation j,;warn in;.; paint product* coutalnlnjj lead 1* *ot forth* TMa regulation bec3aa lau on April 21, 1972. Basically wo will cet ba permitted to chip in intcv.itfito coanerco after Uecenfiar 31, 1972 coy coating which could u j c .U in or around thn household which contains in cxcoes of 0.5ft lead. After TJTivr.t'jsr 31, 1973, wa will not be permitted to chip 1a Inter* state coinnercg ny sucli coatings which contain In excess oC 0.067. lead. The anoint of lev? elicsaable la basod upon the totel weight of the contained sol ids or dried paint film. Secondly, any toy or other article intended for un* by children will not be pormlttod to bo shipped In interstate comserca if it beer* a coating in excess of tin allowable percentages of teed as stated alert corresponding to tho tira periods stated above. Assuming that other federal agencies within the Department of Usalth, .Vimention Ac Wclf/vco adopt the percentssos outlined abonra, it is ny later* pretatlon that f.hs term ` paint suitnMo for use in or around the household'1 will bo expended to Include all coatings in our Industrial maintenance line. The phrase "ahlfpod In interetete encmere*'* l* subject to dobate. I have no doubt that any product* shipped from our manufacturing points to our own outlets or to dealers, etc* would bn products shipped In Intcrstetn coomarce. Questions arise os you go down the chain of dletrlbution. It is ry opinion that deliveries from our distribution units to dealers would also fall within tho tone interstate commerce as well as would shipment* hetvaen our own unite, ft.*., frost district eeotere to breaches An individual who purchases prelects at ane of our stores or from one of our dealers and carrion the preduct tuxes with hln would not fell within the definition of intereteto coecsrco. Hmtevur, thn dollvurie* of our products to n GLD00170* i tf. !>. Klneell - Paco Two March 16, 1972 palntlnp, contractor from our distribution unit, especially If the shipment la actors state linso, would bring the thipmmt or transfer within the definition. Coavotiely, a contractor who picked up the products at our outlet mid carried than acronn stato linos would not he shipping the product in interstate coiraercc. While the ehJpoent of Industrial coating* destined for thwa imlstmtos accessible tochildren do not foil within tho shipment prohibitions, tho strategy is to attack tho end product banning it a* a luuifitdouu oubotenco, and thus forcing tho coating auppllor to coass shipr;outs of theca products. Sectir-j 15 of tho jprdoral Harardouo Subntan<?r*s Ret establishes repurchase^. for banned hnr.nrdous cubn^/incon iditch r^QOlro a pspufaqt'irct tCU. jtopur'dmso up:>n the requout of tha ctntoner pay banned hazardous, subptencaa^ ihio nv:stio that if e dealer or a'cunWior'hrfl products rn hie ohelf which' contain i.crn than tho allow**blo loud content, ha can require us to repurchase tha prcln-t ct tho price ho. paid for them, plus nny cddttlor.Al expenses incurred .'u rotuvnJr.g tho products. Unfortunately the law dees not have ony tins provision which shut* off purchases boforo a certain time. In fact. Section 13 melon that ", . . . any article! cold by Ito manufacturer. . which In a banned Ivir-.axdoua substance (whether or not it was auch at the litre of Ite fsaJa) shall be repurchased." r A recent AsnocJatcd Press article quotes Unicom W. Jansen, Director of the Rurcaufa Product Safety, indicating thatjie favors rcfur*c\B b.ickto the. beginning of tire.'* in the eeno article, Mr. Rudolph A. Vigcono, Chief of ccTiniiance in tho Bureau of Product Safety otated "IJe've tried to aet a starting date effective with the child safety law on Jen. 1, 1970 but general counsel (Pater Ilutt) Insists there be no time cutoff." In light of the above, the repurcheie provisions may turn out to be the biggest headache of this lead paint regulation. 1 shall continue to keep you informed cti matters develop. JEP/rem Attach. John E. Peters GLD001705 1- J V f i 'i f 'i a s 1 >V '* . >.***- TITLE 21--FOOD AND DRUGS CHAI TI' l I-FOOD AND DRUG ADMINISTRATION, d e p a r t me n t o f mk a mu , e d u c a t io n , a h iv w e l f a r e t; SUhCllAPTF.R D--HAZARDOUS SUBSTANCES PART 191--HAZARDOUS SUBSTANCES : DEFINITIONS AND PROCEDURAL AND INTERPRETATIVE REGULATIONS SIMILAR ORDER CLASSIFYING CERTAIN LI :a !)-c o n t a in i::g p a in t s a n d o t iie r ^s u r f a c e COATING MATERIALS AS BANNED HAZARDOUS SUBSTANCES * i ? ' i . .1 ! r' ; In the matter of classifying certain Jcad-containlng paints , , ; f" :i.7i i* ', and other surface-coating materials ar. banned hazardous substances; ... . si In t lie FEDERAL REGISTER of November 2, 1971 (36 F.F.. 20985), the Con.tnfssioner of Food and Drugs published a notice proposing to declare, under f;ecl ion 3(n) of the Federal Hazardous Substances Act, paints and other ruriacu-coatiug materials contaihing riore than specified levels of lead and other named heavy r,idols to be hazardous substances (section 191.5(a)(2)) and to be products requiring special labeling under section 3(b) of the act (section 191.7(b)(7)). This Is referred to below as the Commissioner's proposal. In the same issue, of the FEDERAL REGISTER (36 F.U. 20986), a ' , notice was published on behalf of.pet It loners Joseph A. Page, ct cl., which proposed that paint for household use containing more than minute traces of lend be classified as o banned hazardous substance pursuant to sections 2(q)(l)(U) and 3(a)(2) of the net. This is referred to below as the Page proposal. Approximately 209 comments wore received from Consumers, consumer and public interest groups, the paint: and chemical industries, trade nil I |.IM I'm CUDOOllO6 N 2128.01 associations, physicians, mod icn l schools, prolrIona l societies. lodcro.!, f'tote, nod local government agencies, end otlicrs. The principal' comments arc a3 follows; The American Academy of iodiotri.es, relyingg., on published studies with lend and data respecting the maximum doily permissible intake of lead from source-: of lend in t lie environment constitute a substantial addition to the body b.-iden that can reasonably be avoided and Hint any unnecessary exposure should be eliminated or minimized. It'^'eJ.so stated that the labeling of paint .containers would have little effect in preventing lead poisoning and th.nt point containing 0.5 percent lead will not provide sufficient protect ion for children'* to 3' ' years of age. The Academy ; stated that it is estimated that approximately 50 percent of these children repetitively ingest nonfood substances nnd that abdominal X-rays obtained . {. in the diagnostic evaluation of children suspected of having lead poisoning Indicate that very large quantities of foreign substances such as paint, Jr putty, and plaster may be ingested, often %>ilhout the parent's awareness. The Bureau of Community Environmental Management, Health Services and Mental Health Administration, Department of Health, Education, and Welfare, commented that cautionary labeling does not provide adequate protection, that the availability of lead in paint to children should-bo held to the lowest concentration possible with current technology and -2- GLD001707 consistent with re .*!! oil'll* 1 y v.tT.-cl ir-itu'Cnc t uv ing practices, and tb*t the max inn i coicentrni i o,i of lred in gnints intended Cor use on Interior * .t/ " surface!; readily av.iiljiMc tc children shoe-id not exceed 0.06 percent. H .i Tin' Knvironirciit.il Protection Agency submitted tin Inhousc technical *1 report '.. !irli concluded that lend In paint l excess of 0.05 percent could constitute a danger to the-health of children with pica. They stated.-.-'1. >;' \v. that cnmf cihiry labeling would be inadequate to protect the public , ` health and safety and recor.i.j.endcd that interstate ec'.r-.'ievco. * lrad-br-sed paint he banned froii , .*v "t > '5 t Thi' ir.edic.al community generally endorsed the Tape proposal and \ ` ri supported the roeo-rv.eudaLion of the American Academy of Todiatrica, Rome, phy :iei-ms from medical centers located in large metropolitan areas stibr.ilt ted the results of their own clinical findings and studies S < which Indicate the hazard posed by lead in paint. Other physicians cited studies which indicate that children can accumulate toxic levels of lead over an extended period of time from paints containing 0.5 percent or less lead. Two physicians cited coses of children with excessive j body burden1! of lead which they could attribute only to paint containing loss than bnc percent lead. The medical community generally commented that the labeling proposed by the CommissLoner would not provide adequate protection because subsequent occupants of dwellings would not know what paints were applied by previous residents and because labeling may be totally disregarded or misinterpreted. Nearly all comments from consumers, consumer and public interest groups, and ''government agcncic3 (other.than those discussed above) -3- GLD001708 tVrfi* '\' County of lor. J.os support the iec rsirr.cp.Jat ion of the American Academy o > Pediatrics. So::c curar-nt r. suggested other maximum levels for lead In painty For example, the Congress ioml lUack Caucus recommended that all lend from household paints he banned; the 'Natural Resources TcCense Council and the lie par t rent, of Public Health of the City of Philadelphia recommended O.O.S percent ns n maximum level for lead in paint. Taint chemical manufacturers end their trade associations generally supported the Commissioner's proposal and opposed the Pago proposal. With respect to the Commissioner's propor.nl, several comments requested * clarification of the labeling statement and sufficient time to reformulate and relabel their products. With respect to the rage proposal, many comments stated that the language "minute trnces of lead" Is vague and nonspecific; that the data relied on l*y the petitioners and by the American Academy of Pediatrics is based on lead ingestion studies done with lead compounds other thin the lead compounds used in paints end coatings; that scientific data or human experience has not proven that. GLD001709 V Jl i pa I ill*: containing 1` ' pti cent lentl are hazardous; that lead Is used as n dryer find the substitution of other compounds for load may be hazardous; find that iniplta.enl.ft ion would cause a severe economic hardship licc.'.u.u: it is rot within the- existing state of the art of tho paint industry to eliminate ell load from all paint. Several comments con*^ i tended that the statutory procedures for banning have been ignored In f the Page proposal in that only after labeling has been proven inadequate can consideration he giver: to banning. Other comments stated that warning labels are adequate protection because they prevent nls- , . .> I' .{:- application of paint products and serve tire public interest by allowing useful, needed paint products to remain c.t the market. Some comments staled that lead is a necessary component of certain products (e.g.. certain exterior primers, rust Inhibitors, and automobile touch-up , , paint). A number of paint manufacturers and their trade associations commented that the inclusion of heavy metals other than lead in the Commissioner's proposal is inappropriate. They stated that the toxicity of different forms of these metals has not been established and suggest' that action be deferred pending further scientific investigation. Some manufacturers submitted data which they contend shows that ccvlfiin heavy metal compounds other than ! . ad arc not hazardous, while others stated that adequate test methods need to be developed. Another manufacturer stated that certain of these heavy metals arc necessary in the manufacture of fire-retardant coatings and warning colors. Few comments wore received expressed ar. opinion concerning > that the Commissioner's proposal cs it related to other heavy _ metals, and none of them were supported by scientific data. . *5 Vhe Cixr.ni r. r. lorn. r , 1 -i I . i b' ' '* % ! i *! i *! considered the cvivnils and ether relevant imtci i.il , o ! cili'S .".r, follows: *. * 1 " Alt lioiij.l. ( tints end Mh.-v surface*coal ing materials containing lend f (-s p f I , j; *1 ci li 't ptvsertf rn im.iiiv at ha-ire! to the public health, they oust be ccnsidfcreWv'l ^ " on thf bnsi:, of cumulative toxicity* ever extended periods of time and in. f y ; f !"' conjunction with oth-r sources of lend in the environment. Rased on the-. currently available scientific and medical data, regulatory action tnust.be l f. j i. 1 1 i: 'i tal'.oii to mi n i ..i i xr- the lie.il t.h hazard to fol tire geneva t Jons. ; The hrallli hazard fre.r lead will not be effectively eliminated by '" cautionary labeling requ ire: .infs. The statute decs not provide that such labeling must be tried and proven inadequate before a hazardous substance can be banned. Instead, section 2(q)(l)(B) explicitly prov.idcs for banning / products fron interstate, commerce on the basis of c specific finding ''notwithstanding such cautionary labeling as is or may he required" (emphnr, i s r.npp 1 i ed ) . ^Cautionary labeling has not been proven effective in eliminating lead poisoning in nv.ny cities which presently have such requirements. In any event, the hazard persists long after the product lias been separated frost t Its labeling. The'prudent course of action is to reduce, as rapidly as possible, the amount of lend to which children are exposed. The Commissioner agrees that limiting the amount of lead to "minute traces," as set forth in the Page proposal, is not feasible because that phrase Is vague and would not provide manufacturers with specific standards, and It could not be effectively enforced by the Food cud Drug Administration. In addition, limiting -6- GLD001711 . '> V ` i *v m I - ' (i- ' only \; regulatory aclion^to paint-'' \ is inadequate to protect the pub Lie health nil'! unfrty bec-iiise other surface-coating materials containing lead are use0 In nii'l h i ('mid the household and crc accessible to children. t1 i ~ ; l-.VV r'' \ The preponderance of i . Steal opinion supports a regulation limiting the. `V : V-1 auionnt of load in products intended Tor interior surfaces and for toys or '* ) other children'.', articles to 0.05 percent because that level will provldn margin of safety. However, such a regulation would not prevent the uoc 6f * 4' produ-'-t a containing highti amounts of lead on exterior surfaces. These : ; surfaces, ore generoily as accessible to children r interior surfaces, end, i. . f* ' as the twitciU? point out, children have l.t-en subjected to lead poisoning ' by ingest i up, products containing lead that were applied to exterior surfaces, In addition, if products containing icid^arc available for exterior use, l they i.ny be misused for interior surfaces. The Commissioner recognizes that restriction;: placed upon the use of lead i-ny result in economic hardship and in the suhst itut ion of other components lor use as dryers. The statute makes no exception for economic i hardship. Several compounds have been suggested as substitutes for lead. ' Each manufacturer, prior to marketing consumer products, must take steps to determine that any substitute lor lead has been adequately tested for safety and sliov.'n to be safe. Any banning order should therefore provide a reasonable time to test substitutes for lead and establish their safety, and at the same time provide adequate protection to the public. The national Paint and Coalings Association, which represents more than' 900 companies, has notified the Commissioner that it anticipates Its -7- GL0001712 " ) >!^-j n . f"' *, i-'.i-i 1* < cun pit i'ii' c by .linn . i _, !'>7A luteri 1 r pJVi.ucts not exceed 1 ng the ii nd 0,l)(. I'liiiMil i i iu;\ 1 *-! 5 lev. \ ? -in j. .<! v-f hy .l.uiuury 1'.//' rxtci 1 or ' /I i ^ i < > 11' c ; n"l i i| i iij- (j., n.Oi, pi i: i i Kii i: i ) o.: * 1 li v*.-]. Some paint 1 : mill ile-mii :! i.. tiuf no t h i i' i 'i.iV' no l i i i r 1 till'. ( e: :'i L f; { i one)' tint they can V, a rcTci ni'J.'iLc i In j v j.i-f.ilitc tto u*-ot 111'.' 0.06 i-c it .i lit maximum lead level r * in a .shorter t i i. * peri oil. f-.; February 19, 197/, a notice was published in tin lT.ni.i;A!. hl.CIS'i Kit ('1/ ]\K. 370) requesting lint additional infoiv: 11 it ;i f i ' t he i rjI; : 1 r v be r nlci i f ! ed by April 7, 1977. If, after con;; i d* r i ii:; i: i j nt'u.'i; a l i c-n, the Coir.iii nsi.euer finds lh.ll 1 old can he eliminated f. rim punts and ether surface-coaling iv .i t ei j al s wore rapidly linn I lie .'Ht.i I ion date;: specified in the I oHei.'i up, order, an approjiviatc .'iiujii'h:nt \7ill he iiiade. Therefore, the Commissioner finds that, notwithstanding such cautionary ** labeling nr. is. or may ho required under the I'cdcra T Hazardous Substances Act, tlu: dcgii e or nature <>f tile hazard involved in the presence or use of lead in' paints mid other surfai e-coat ing materia Is in households is such tint the objective of the protection of the public health and safety can be adequately served only by keeping such substances, when so Lnlcnded or packaged, out of (he channels of interstate commerce. Under section 2(q)(l) of the act, this will have the additional effect of banning such products from use on any toy or other article intended for use by children. Since lend may he a neci-ssny component of products intended for particular uses, as suggested by several comments, the Conmiissioner is 1 prepared to consider petitions proposing amendment of the regulation. Pursuant, to 21 Cl'R 191.201, petitions shoeing reasonable grounds will be published in the FliDhRAb KKGISTHH. Consideration will also be . , given in lale 1973 to petitions for 8- - GLD00171-3 'l V'> -3* I ,% * *' ) mmurrn wmmmmmmmrn . . , .~i ? ;i extension i>! the i mo ! i .; n l;-l i u:i elite upon a .'howmi; that t lie public health j, , X' ; ,>, 'i Vi I l not Ic leopard i:-..-d .-.id ti tvc!.u.<l c",!r.:J tu-ver.:. i t y requires Additional I* '1% t line to ar.i-i the Q.O'i jM'icPru t'lnxjiiuim lend level. .i l I, At tli is 11 me, further i n f onsa t ion is required be I ore final order ! ' 'i| . tl ' '*! can !>e pr Vented regarding the use of certain c leaser: l:., other than leadyjj/^ in paint and other sm f.n'r-cc 'U ing, j.:ater ia 1 s. Additional data on the use9" j* 5 * of these s..!,.t r-v inis v?Ill te obtained in venponso to the IThLlRAL Uf.GtSTFR'4! . notice of February 10, 1.1)72,(37 F.U. 3780), md these products will bo ' considered n a later date. :v '. \ >: Therefore, pursuant to provisions of the federal Hazardous Substances , Act (nets. 2(f)(1)(A) , <q) ; 74 Slot. 372, eu amended, 80 Stnt. 1304-05; ' 15 U.S.C. 1201(f)(1)(A), (q)) and the Federal Food, Drug, and Cosmetic.; Act (sec. /01(e), (I), (g) ; 52 Stat. 1005-55 nr mnenckd by 70 Stat, 910 and 72 fitn. 9\3; 21 It.S.C. 371(f ), (f) , (?,)) and under authority delegated to the Co. T.iss ioae.r (21 CFR 2.120): It is ordered. That Fart 191. he ar.iendi u by rd.d 5 r.-j, t new nubparegraph (6) to 5 191.9(a), ns follows: . . .J s 8 191.9 banned hazardous substances. 'j d ; (o) Under the author ity of section 2(q) (l) (r.) of the act, the Commissioner declares as banned hazardous substances the following ' articles ber.nmo they possess such fi degree oT hazard that adequate cautionary labeling cannot he written and the public health and safety can ho served only by keeping, such articles out of interstate co:t.rrcvce i \ * j- t \ r "I * f ' ;/>. - 4`,.i i " M 4.* (6) (i) Any point or other similar surface-coatLng material Intennot >d*,1fetdil ,'!^-r:i' V-- -.&w . item-*4 or po.jckl nged in a form suitable, `for use in or around the household that: ' ' -.'W ii'i'0 (a) Is ..'shipped in interstate commerce after December 31,'. 1973, V* ,. i r.'[\4 * contains lead cor,pounds of which the lead content (calculated as tha meti^l.)*;^ ia in excess of 0.06 percent of the total weight -of the contained solids \t` T * 'J ,, -i or dried paint film; or d , * ip . ' (h) In shipped in interstate commerce between December 31, 1972, . * i w` ' * - "A V,''-1 j ' * ( ` *.J?&, V and lice ember 31, 1973, and contains lead compounds of which the lead' content (calculated ns the metal) is in excess of 0.5 percent of the i- "f- i '"Ji*- ` total weight of the contained solids or dried paint film. ' * " * 1* '*.' .-*'^2. ' fV >' (ii) Any toy or other article intended for use by children that: ` !4-i ; ; .''( V -1 ? . , (a) Is shipped in interstate commerce after December 31, 1973, ' a . ..... * ' I ; , :* : and bears any paint or other similar surface-coating material containing [ lead compounds of which the lend content (calculated ns the metal) is , in excess of 0,06. percent of the total weight of the contained solids *. >t-l *.k ! or dried paint film; or ^. * :, A -A. , ;; u (1>) Is shipped in interstate commerce between December 31, 1972, ^ ; ' V' and December 31, 1973, and bears any paint or other similar surface-coating ' * material containing lead compounds of which the lead content (calculated /' ` ' i as the n.etnl) is in excess of 0.5 percent of the total weight ,of the. S> contained solids or dried paint film, .. . ' ** . ,V 1 - )x - *. *'* t,* . jl ; :"'vv^ W:>: ; j -10- .i " if ot*; ' ' yvvv- ' ; . xvi - ' ` i ... 1. >: ' -l * . *V. . *' m S >. ;: a- v /t-X :"T; 1- *i` ,, p' . `^.1 stooow1' i '..M:;Sfo4ri -X,' /V'.`'v,f:,.. {?<.*>*,fay-} Any person v;hu will hr. adversely affected by the foregoing order . nay at: any tii;/.* x'ithin 30 day?. after itr. date of publication In the ' --i/ H*\$ >. ' t FEDERAL 1:1 *5TKlt file vi t h lie- Hearing Clef'.:, Depart :n,nt of Health, > (>' Y ` ** % I'ducn i i (;), and Del fa re, Uoora 6 * 39, 5600 Fishers I.nne,' Rockville, "* ` Y .'Y v? Mary 1 artel ?C'..5J, writ ire objections thereto. Objections shall show , j- ft ` >Y -I : wherein the person filing will Sat adversely affected- hy the order atid v > , . { j'i t'* , specify with particul;r i 1y the provisions of the order deeded objection* ,i -r .* t nble and I lie grounds for the-object inns. )f e hearing is requested, Y** ! . i ` i ' J objection". ru;t st^fo Hit- Issuer, for the heaving and such objections nnlt ; 5 be supported by grout-Vs legally sufficientto Justify the* relief cought,' Objections may be ncc cr.p'ni ed by e lacmorantben or brief in Support thereof, All docucats shall be filed in six copies. Received objections tnay be seen In the above office during working beers, Monday through Friday, Effective date. This order shall bocone effective A6 days after its date of publication in the FEDERAL REGISTER, except as to any provisions . that may bo stayed by thr filing of proper objections, Notice of the filing of objections or lack tb.-reof will be given by publication in the' FEDERAL REGISTER. ' 1' (Sees. 2(f)(1)(A), (<j), 74 Stot. 37?, as amended 00 Stnt. 1304-05, 15 U.S.C. 1261(f)(1)(A), (q); sec. 701(e), (f) , <g) , 52 f-tat. 1055-56 ns amended by 70 Stat. 919 and 72 Stat. 968; ?l ll.S.G. 371(e), (f), (g Doted; `V'* aMHWdmr.*., <i ' ': ' -11- YxV'Yl :'*-7 GLD0O1716