Document O3D1L5OedejMMjQKd0qDKnvDL

A. 0. Ungntroni January 11, 1973 Clovalnnd '""v /> i\ fuayyz me t a l s -/s t a t u s u n d e r c u r r e n t k e q u l a t x o n s W. Kirkwood Kelley #32 ccs Dcmnld Koacl - Ton^n Jim Johnson - Itlnneepolta J. G. Kingston - DPJRC There two broad cleanes nf yeas to bo covered - food packaging end protectl'i-w/decoratlvc coot logs. Food psckrtfllrg materials usually corns under VO* regulation* nrct th* only Safa pmc^dtu* for metals such as 1 le.ul, *-d' iwm r,r>d nnj.onlum i* to eatsMinh that there in no migration to i'.iio . fond undor the nj'eeifT.e nn rendition*. Xf there is no migration, then f.!o porbofsitif* material is not: .* food addit ive rod. jr tx^t subject to Jie yiv'i indirect cddltinea i-ojyOntlonn. Tf the probr.nluj* wttntfsi in to I.j used lo n pjnot undot inspect ion., It in naconrary to obtain approval ;.:ro:a tho Aotmal and Tonitry Jl^nlt-l\ Tnepeetion service (AXIliS formerly known < 3 M'ZD or MIS) for each apar.i fir. product and one. 7ha *" data 1 roqulre-1 ho support a no migration position, and tbs data jmint bo. embmitted to U3PA for review. Tho uoa of the subject heavy pv m-p Ia in protactlve/t'Qoovntl.vo costing* is L:.iii>g questioned under the proclaims of thn Federal Hererdoiis Substances Act, Tor.'.oi iy known no the Federal. Uerardous Substances Labeling Act. Wills many <>i:hov cc,,0(-y.^e>!1 m-fl tu-inp; ve(*<'rded with suspicion, attention hss focused on tuo retain, pnrticnlarJy rorrury nod lend. The heavy metals referred to :;o o 1 <! (:i f-led nod >1 in on i*<du^t>'y ri'^cificntion (A11SI ?6f. 1.-196A - Coat Uv.,* mv ourfncofl tdiinj, night bn cbwM by children). Tbs surfrcea nrn Uioca of children* a fm vi j nc f/-ye ami interiors in deoil lugs. The dry film r.olid'i cha.il cop tain not m >m than |% l.oo.dj rh.*j.). contain not morn than 0.067, total of Sb, An, Cd, jin ard shall not contain j'n compounds of mhlr.h ths meter soluble Hs content ococcd** 17, of rhn total pn. The portion of this standard relating to le*>d ooiinnt of 17, r''r).^i,n ic cbnolofn and is pre-empted by the PPA regulation, Section 191.9 Aper.ifyitMj 0.57, nwdmum for lend. Thoro ara no really unsbls Fh* roguintlonn ralntinR to p.oy of tlisiia natal* in uc itnct with food. Ons nip liflcnnt. petition ban been filed on selenium by thn American Food Manufacturers Asaor.intipn on .Tun* 17, 1971. This petition civ.r, thet 03lnnium b approved for ties in certain animal fasds *t levels of Icon"than 1 ppra. GLD007102 l:Itc!t<:l Kelley -2 January 11, 19 )' 'A n propnenl on November 1, 1971 for gpoll lobe lit* it of pnintp v;i!v J.;I.*'* (n) ' 'j v o thnn 0,57. load; or (b) more then 0.0^7- of 9"', An, Or!, 11s, ; o :.: <) with water rolublo Pa content: Above 1% of the tot*! )'rt. Also no !'r,''br.'r 2, 197), n pof.ition by n cons'imr group woo publ.i*1*<1 fl,-.i.nr< to heap \v\ V*ccato1ni.oR point, n and other meborloTn formed as hn ravel min snbetosrten. `hi j-'uv/.iui ry 19, 1972, FDA publIohed n t for -lets oil the nr-iountn of h-invy In pnlntn bnlnp, u"Ad ou mjrfflcco nccenajhlc to children, Tt. e:;- j 1 < !''( pit!>i t '"**> rad* hncnunn Fi'A did imt. Iinve so f 1 clout In- ? * -m rti r> rr> yr? * o * v-'op.nl nil on. The National faint owl i.v*s.t fr y a .,1oic ti.uu nvl O'ffM'O* uHicy t t.o'lA nv-giwi -nt.|i))>r |im| 1 >> |.n r<or'ct v|th XuA fol 1 (W.h'f t.ho Tiny/- her 7 , 197) pub I i-f\ r-nd u l.yAn f;!*0 'tail of plnnr to obtain h'f;i .n't'l'''' >>( a nu:,T' >>- of t ho I'/'ru".' matol.p fu' -it of tlmea referred to ni'nio. 9c-a individual. ff rm hd n1.;>o i.nf.-o< H'A that anlnsl ntudle* novo. contr.mpioiiad end would re|ttI to rom time to completes. On Mnrc.1i 11, l.S 72, FPA p"'-) 'hod the fin-Hugi on ft**' t-;y novcm'iof ?, 1971 proposals end etrtt,'d lint fu'lhcr information f<j io(|i,lic','j before a fin?) order can ho written remrding the coo in pjWrtp of the metals other thou lend. An amend,nmtt to ;;ocV.lfM< 191.9 wan included lionising pnlru.n containing more then 0.97 load effective .Tannery 1, J*.*73 and paints containing more Lb.Aii O.OfiT, loud effective Jonmn v 1, 1979, ('-I Aog'int 11, 197?., FUA published a nummary of cement a received on the !'troll 1.1, 1972 order and concluded that, the effective Ante of thn paragraph minting to the 0,067, lord should be stayed and won Id he the subject of n cjpnrnto document at /? later date, Tima far, no ijch duunmant In* been I'.ubl J cited rind wo do nol. orj-oct any for rd' Jcnuf ft ja'tw. On lTocembor 3, 19/?, Kt'A puliliched the proposed enoept.ion for aoven clnsaoa of pnlnto nn reijnoiyted by ?"oA end nl.ao pid>Hr)>eJ t:he text of Hie petition ntthnii:tod by HfOA. The latoo'. action by fl'A ia fi proponed evrjription on January A, 1973 wliirh co>,oin rrfint'e painlB nod minted pnterlnls art tlie clf/uth nines oxempteil fioo tlie ?bueh 1), 1772 order, 'fii-a altovo covoro thn inportant. dcvclopre.iti.n nnd you1 will note tlist nt prcecnt thoru are no specific regal nticrwj etdicr than tbona on lead'and rlnrooty. M, do ov-jsfict. n rogulntion aimljnr to AM-11 rd6,l-19f'A but not for aon>. time, potiniis a year. When the proposal la fanned, tie ho.!love tliat t.licte vlll be rorpi jsta for exemption of. cat tain ciaeeoa of jlainta nod for Art Ufa points. Copies of thn FM rcgulntiona ftnd propoeal.R mentloiied ftlunn iir? Attnchod. Pinnae give me a call if there is any ijnention on any of the nbr^'e. t cn:cb r-u:in. A. 0, Fngstrom 1-M GLOOO^01 NOTICES 11675 . _ ilce 't other public procedure has (DESI 6181] ,h o prec< led promulgation of the foregu u k ruh since it is found ttmt tire gtv- CERTAIN PREPARATIONS CONTAIN lru, of such notice would prevent, the due ING DIMYPRYIONE OR PIPAZE- mid timely administration of the THATE HYDROCHLORIDE , Packers and Stockyards Act and would, therefore, be impracticable and conlrary Drugs for Human Use; Drug Efficacy to the public interests. There is no icp.nl Study Implementation warrant or Justification for not dcpnstlng ' promptly a rtockyard which Is no lunger v.ilhin the definition of tliat term con tained in tlic Act. Tlio foregoing is in the nature or a rule granting an exemption or relieving a restriction and, therefore, may be nindo effective in Jess than 30 days after publi cation in the Fr.nr.aM. Ilrcisnn. Tills notice shall become efTeclivc upon publi cation in the Fid e r a l Re c is t e r (0-1771). The Food and Drug Administration lias evaluated reports received from the National Academy of Bcicnces-Nattonnl Research Council, Drug Efficacy Study Group, on the following drugs: 1. Sedition Syrup containing diliypiylonc and extract of thyme; Roche lab oratories, Division Hnfiinnnn-LaKoehe, Inc,, Uochc Park, 340 Itingslcmd Street. Nutley, New Jersey 07110 (NDA 6-151), 2. Tlierntuss Tablets containing pl- pa net ha to hydrochloride; E. IT. Squibb < Mat. 150, As Amended and supplemented; and Sons, Ct)9 Third Avenue, New York, 7 UJS.C. 181 et iwq ) New York 10022 (NDA 12-820). Done at Washington, D.C., this lOtli day of June 1871. O. If. Homx, CltieJ, Hegistrailons, Ronds, mill Jtejiorls Branch. Livestock Marketing Division. Rneli drugs arc regarded as new drugs (2.1 U.S.C. 321(p)). The effectiveness classification and marketing status are described brlow. A. Eflcetii'cncss classification. The Food rnd Ding Administration 1ms con sidered the Academy's reports, os well JFR Due.71-U517 Filed G 18 -71 ;fl: ,r>0 dun] ns other available evidence, and con cludes that these drugs are possibly ef fective for the labeled indications re lating to the relief of coughs. DEPARTMENT OF HEALTH, II. Marketing status. Marketing of such drug with labeling which recom EDUCATION, AND WELFARE mends or suggests its use for indications for which It has been classified ns pos sibly effective may lie continued for 6 Food and Drug Administration monlhr, os described in paragraphs (d), AMERICAN FEED MANUFACTURERS (e), and (f) of the notice "Condliions for Marketing New Drugs Evaluated in Drug ASSOCIATION, tNC. Efficacy Study," published in the Fr.n- Notice of Filing of Petition for Food Additive Selenium e r a i. Rec is t er July 14, 1970 (35 F.R. 11273). A copy of the Academy's rrport has Pursuan* to provisions of tlic Federal been furnished to each firm referred to Pood, Drue, and Cosmetic Act (see. 409 above. Any other interested person may (b) (5), 72 Stat. 1786; 21 U.S.C. 348(h) obtain a copy by request to the Food and (6)), notice is given that a food additive Drug Administration, Press Relations petition (MF 3433V) has been filed by Office (CE-200), 200 C Street 6W., American Feed Manufacturers Associa Washington, D.C. 20204. tion, Inc,, 1725 K Street NVV.. Washing Communications forwarded in re.si>onsc ton, D C. 20008, proposing the establish to ttiis announcement should bo iden ment of a food ndcUUvc regulation (21 tified will) tile reference number DESI CFR Part 121, Subpart C) to provide for ,, 6151, directed to the attention of the i the safe use, as a nutrient, of selenium 'appropriate office listed below, and ad- ! from sodium selenite or sodium sclennte , 'dressed to the Food and Drug Admin- j- in the feed of chickens, turkeys, and * istruhon, 6600 Fishers Lane, Rockville, |! j swine so that the total selenium cuntent in complete feed does not exceed '(r'Maryland 20852; 1 , i 0.25 part per million In feed for chickens and swine or 0.35 part tier million in feed for turkeys. The premix which is incorporated into the feed is to be marked to indicate the presence of added selenium iLSlipplcrncntn (Identify with NDA number) : f Office of Betnitlfic Evaluation (BD-100), j Bureau of Drugs. ?! original new drug applications; Office of Scl- | ent.lflc Evaluation (BD-100), Bureau of .1 Drugs. '^in the premix and the finished feed. j All other communications regarding this an- > Dated: June 4,1971. ^ Sa m D. Fin e , nounccmcnt: Drug Emcacy Btudy Imple- 1 mentation rroject Office (BI> 8), Bureau | of Drugs. Associate Commissioner lor Compliance, |FR Doc.71-8474 Filed 0-1B 71;8r46 am] Tilts notice is issued pursuant to the provisions of the Federal Food, Drug, and Cosmetic Act (secs. 502, 505, 52 Stat. 1050-53, as amended; 21 T7J3.C. 352, 355) and under the authority delegated to the Commissioner of Pood and Drugs (21 CFR 2.120), Dated ; May 20,1971. Sa m D. Fj h e . Associate Commissioner jor Compliance. |FK Doc.71-8475 Filed 6-16 71;8;4n nm| lDEfU880t| ERYTHROMYCIN TOPICAL OINTMENTS Drugs for Human Use; Drug Efficacy Study Implementation The Food and Drug Administration liar, evaluated reports received from the Na tional Academy of Sciences-National Re search Council, Drug IC/flcacy Study Group, on the following preparations of erythromycin ointment for topical use; 1. Erythrocin 1 Percent Ointment, containing erythromycin; Abbott labo ratories, 11th and Sheridan Road, North Chicago, Illinois 60004 (NDA 60 -184). 2. Ilotyciu Ointment, containing eryth romycin; F.li I,illy and Co., Post Office llox 618, Indianapolis, Ind. 46206 (NDA 00-646). The Food and Drug Administration concludes that tlic above listed drugs are possibly effective for their labeled indications. Preparations containing erythromycin arc subject to the antibiotic certification procedures pursuant to section 507 of the Federal Food, Drug, nnd Cosmetic Act. To allow applicants time to obtain and submit date to provide substantial evi dence of the effectiveness of the drugs in those conditions for which they have been evaluated as possibly effective, batches of these drugs which bear label ing with those indications will be ac cepted for release or certification by the Food and Drug Administration for a period of 6 months after publication of this announcement in tire Fed er al Re c is t e ii. To be acceptable for consideration in support of the effectiveness of a drug, any such data must be previously unsubmitted, well organized, and include data from adequate and well-controlled clini cal Investigations (identified for ready review) as described in S 130.12(a) (5) of the regulations published in the Fed er al Rec is t er of May 8, 1970 (36 F.R. 7250). Carefully conducted and documented clinical studies obtained under uncon trolled or partially controlled situations me not acceptable os a sole basis for live approval of the claims of effectiveness, but such studies may be considered on their merits for corroborative support of efficacy and evidence of safety. At the end of the 6-month period, any such data will be evaluated to determine whether there Is substantial evidence of No. in------ 7 FEDERAL REGISTER, VOl, 36, NO, 117--THURSDAY, JUNE 17, 1971 GLD007103 N 2260.01 PROPOSED RULE MAKING 20985 ' be held confidential and a determina [ 21 CFR Part 1481 1 I 21 CFR Part 191 1 tion is made that a proper showing in auppc.t of the request lias been made on the ground3 that Us disclosure could ndvcrscly affect such person by disclos ing Information in the nature of trade secrets or commercial or financial in formation obtained from any person end COMBINATION DRUG CONTAINING NEOMYCIN SULFATE AND AMPHO TERICIN FOR ORAL USE Proposed Revocation of Provisions for Ceiliflctition HAZARDOUS SUBSTANCES Proposal To Declare Ccitoin Heavy Melat-Containing Points caul Other Surface-Coatings To Requiie Special Labeling for Child Protection privileged or confidential. II it is de termined thnt n proper showing lias been made in support of the request, the ma terial will be held confidential; other wise, notice will be given of denial of such a Tequest and an opportunity af forded for withdrawal of the submis sion. Requests for confidential treatment will be held confidential (7 CFR 1.27 tel). Comments oil the proposal should l>eat a reference to the date and page number, of tills Issue of the Feu er al In the Fe d e r a l Re g is t e r of July 2, 1970 (35 F.R. 10793; DESI 11212), the Commissioner of Food mid Drugs an nounced the conclusions of the Food and Drug Administration following evalua tion of reports received from the National Academy of Sclences-National Research Council, Drug EITlcncy Study Group, on a certain oral preparation containing neo mycin sulfate and nystatin. The drug was regarded ns lacking substantial evidence, ns defined in the Federal Food, Drug, and Cosmetic Act. thnt It is effective ns a The heavy metals antimony, arsenic, cndmlum, lead, mercury, selenium, and soluble barium may be toxic when in gested, even in small amounts. Because children may chow on interior and cer tain exterior residential surfaces and on toys and other children's articles, tlio Commissioner of Food and Drugs con cludes that paints and other surfacecoating materials arc hazardous sub stances requiring special labeling warn ing agninst their use on such surfaces if they contain more of these heavy metals Re g is t e r . fixed combination lor Us claimed clinical than Is essential under good iinniifnclur- Done at Washington, D.C., on Octo ber 27,1071. Ke n n e t h M. Mc En r o e , Deputy Administrator, Meat and Poultry Inspection Program. effect and that eacli component of the drug contributes to the total effects claimed for such drug. In addition to the section of the anti biotic drug regulations describing condi tions for certification of such prepara ing practices, or in any event If they contain more than 0.5 percent lead; or a total of 0.05 percent of the oilier heavy metals listed above on a dried weight basis, except for soluble barium which shall Constitute no more than 1 percent (PR Doc.71-15887 Filed 11-1-71:8:47 am) tions, another section describes condi of the total barium present. The special tions for certification of a related drug, labeling to be required shall include ou Fungizone Tablets, containing neomycin the main panel a cautionary signal word DEPARTMENT OF HEALTH, sulfate and amphotericin n. An approved "Warning", a statement of tho hazard Form 5 antibiotic drug application (NDA "Contains " (tho blank educ at io n; and w el f ar e Food and Drug Administration 60-514) Is held for tills drug by E. R. being filled in with the nainc(fi) of the .Squibb k Sons, Inc., 5 Georges Road, New applicable heavy metal<8)) nnd Instruc Brunswick, N.J. 08903. tions to read carefully the cautionary Tills product was not reviewed by the information placed on other pancKs) I 21 CFR Parts 27, 31 1 Academy; however, the Food nnd Drug where located. Existing technology will Administration, having evaluated data permit Industry to produce household CERTAIN ORANGE JUICE PRODUCTS originally fllcd In support of efficacy of paints containing no more of these heavy Extension of Time for Filing Comments this preparation, concludes that there Is a lack of substantial evidence, as defined metals than is specified above. As new technology becomes available, the accept on Proposals Regarding Stayed in the Federal Food, Drug, and Cosmetic able levels may be further reduced In Identity Standards Act, that this drug is effective as a fixed accordance with good manufacturing 'fTie notice published In the Fed er al Reg is t er of September 9, 1971 (3S F.U. 18098), proposing to revise the stayed standards for the diluted orange julco beverages (f| 27.120, 27.121, 27.122) and proixxslng establishment of additional identity standards for certain related products, provided for the filing of com ments within 60 days after said date. The Commissioner of Food and Drug* lias received a request for a 30-dny exten sion of such time and, good reason there for appearing, the time for filing com ments on the subject proposals Is hereby extended to December 8, 1971. Received comments may be seen In the office of the I Tearing Clerk, Department of Health, Education, and Welfare, Room C-88. 5000 Fishers Lane, Rockville, Md. 20852, dur ing working hours, Monday through Friday. lids action is taken pursuant to pro visions of the Federal Food, Drug, and Cosmetic Act (sees. 401, 701, 52 Stat. 1046, 1055, os amended, 70 Stat. 919, 72 Stat. 948; 21 TJ.S.C. 341, 371) and under authority delegated to the Commissioner <21 CFR 2.120). Dated: October 15, 1971. combination for its claimed clinical ef practices. fects, and that each component of the Although paints containing small drug contributes to tho total eflects amounts of lead in excess of the pro claimed for such drug. posed levels may not be toxic in them Accordingly, the Commissioner con selves; when considered In conjunction cludes thnt the antibiotic drug regula with other sources of lead la the environ tions providing for certification of such ment they constitute a substantial addi drugs should be revoked. tion to the body burden that can reason Therefore, pursuant to provisions of ably be avoided through the application the Federal Food, Dmg, and Cosmetic of available technology. The Commis Act (secs. 502, 507, 62 Stat. 1050-51 as sioner has concluded that tire scope of amended, 59 Btat. 463 as nmended; 21 the Federal Hazardous Substances Act U.B.O. 352, 357) and under authority fully encompasses the question of cumu delegated to hltn <21 CFR 2.120), the lative toxicity. Commissioner proposes that Part M8i be nmended by revoking .5 1481,45 Neomy cin siilfatcamphotcricln B tablets. Interested persons may, within 30 days after publication hereof In the Fed er al The American National Standards In stitute, in Its voluntary standard Z66.I, has specified a maximum limit since 1955 of 1 percent lead in paint Intended for Reg is t er , file with the Hearing Clerk, use on children's toys, furniture, or In-., Department of Health, Education, and tcrlor surfaces. A 1-pcrccnt lead level ! Welfare, Room C-88, 5GOO Fishers Lane, was also adopted by Congress In the ; Rockville. Md. 20852. written comments (preferably in qnlntupllcate) regard ing Otis proposal. Comments may be ac Lead-Based Paint Poisoning Prevention J' Act (Public Law 91-695; 84 StRt. 2078), f\ companied by a memorandum or brlet (Which la administered by the Bureau:;! In support thereof. Received comments !of Community Environmental Manage-;' i may bo sera in the above office during merit, Health Services and Mental Health j / working hours, Monday through Friday. j Administration. Tliat act prohibits the ! Dated: October 19. 1971. ; use of paint with a lead content above I; Sa m D. Fin e , Associate Commissioner for Compliance. Sa m D. Fin e , i I i>crcent In residential structures con- (. Associate Commissioner strutted or rehabilitated by the Federal i'' for Compliance. V (government or with Federal assistance, j (PR Do o .71-15908 Filed 11-1-71:8:45 am) 1FR Doc.71-15909 Filed 11-1-71:8:45 am) As an additional margin of safety, the FEDERAL REGISTER, VOl. 36, NO. 211--TUESDAY, NOVEMBER 2, 1971 X GLD00710 A I 1 N 2260.02  209R6 PROPOSED RULE MAKING* 2d^ (?> Commissioner propose* to reduce the ex this regulation, containing any of the Dated: October 28,1871. posure to lead Pound acceptable by Con- heavy metals specified below at a level grass by establishing special labeling exceeding that which Is essential under requirement* for all household paints good manufacturing practices or In any Ch a r l es C. Ed w a r d s , Commissioner oj Food and Drugs. containing inoro than 0.5 percent lead, event containing amounts of such heavy |FKDoc.71-169ai Filed 11-1-71:8:83 *m] Consideration has been givcu to the metals ns follows: question of whether paints containing (1) Lend compounds of which the lead lead above the level specified herein content (calculated as the metal) is In [21 CFR Part 191 1 should be banned from Interstate com excess of 0.5 percent of tlio total weight BANNED HAZARDOUS SUBSTANCES merce, or required to bear special label of the contained solids or dried paint ing warning of the hazard involved and film; or Proposal To Classify Palnls Containing giving instructions for safe use. While there are numerous reports of serious Injury and even death resulting from the Ingestion of Hie dried film of old formu lations of paints containing high levels of lead, the Commissioner is unaware of any similar reports as a result of inges tion of paints containing 1 percent lend or less. The Commissioner has therefore concluded that .rji^t-lonary labeling will bo adequate to proterTdThp puMIoTicalth (ti) Antimony, arsenic, cadmium, mer cury, and selenium of width the metal content Individually or In total (calcu lated as the metal) exceeds 0.05 percent of the total weight of tlic contained solids or dried paint film; or (111) Barium compounds of which the water soluble barium (calculated as the metal) cxceods 1 percent of the total barium present. More Than Minute Traces of lead The Commissioner of Food and Drugs has received a petition, submitted pur suant to Section 701(e)(1)(B) of the Federal Food. Drug, and Cosmetic Act (21 U.S.C. 371(c) (1) (ID), proposing the issuance of a regulation under section* 2(q) (1)<B) and 3(a)(2) of the Fed eral Hazardous Substances Act (15 U.S.C, 1201, 1262) classifying as banned haz ardous substances paint for household and safety from any potential hazards 191.7 FrotbirlH requiring special label use containing more than minute traces associated with the use of such palnls. ing under section 3(b) of tlic art, oflead. ' Accordingly, under section 3(a) of the . The petitioners are Joseph A. Page, As Federal Hazardous Substances Act, the Commissioner proposes that paints and other Gurface-coattng materials be de clared to be hazardous substances (as defined in section 2(f)(1)(A) of the Act) that require special labeling as spoolfied herein if such paints and other surface-coating materials contain, on a dried weight basis, more than 0.5 per- (b) Tlic Commissioner finds that these substances present special hazards and that tho lalxdinfc required by section 2<p> (1) of the act is not adequate for the protection of the public health. Un der section 3(b) of the act the follow ing specific label statements are deemed necessary to supplement the labeling re quired by section 2<p)(1) of the act: sociate Professor at Georgetown Uni versity Law Center, Anthony L. Young, student, Mary Win O'Brien, student, William F. Rynn, U.S. Congressman, Jack Ncwfleld, author, and Edmund O. Rothschild. M.D. The petitioners propose that 5 101.9(a) of the hazardous substances regulations be amended by adding thereto a new sub ' cent lead; or a total of more than 0.05 percent antimony, arsenic, cadmium, mercury, or selenium; or soluble barium In excess of 1 percent of the total barium present. Finalization of the regulations proposed herein, in conjunction with section 2(q)(l)(A) of the Federal Haz ardous Substances Act, will have the additional effect of automatically ban ning any toy or other article intended for use by children which is produced after effective dale of these regulations and which bears such paint or other surfacecoating material. Therefore, pursuant to provision* of the Federal Hazardous Substances Act . (7) Paint and other surface-coating materials declared to be hazardous un der ( 191.5(a) (2) shall bear on the main pane) of their label, in Rddttion to the requirements of 1191.101(a), the state ment "contains", the blank being lined In with the name of each heavy inetal present in the amount spe cified in 5191.5(a)(2). Bucii paint and other surface-coating materials shall also bear on their labeling the signal word "Warning," and the following additional statement or its practical equivalent: paragraph (I 191.9(a) (6)), as follows; 191.9 Bnnnrd hazardous ub*Unee. ( ) Under the authority of section 2(q> (1) (B) of tlic act, the Commissioner declares as banned hazardous substances the following articles because they pos sess such a degree of hazard that ade quate cautionary labeling cannot be written and the public health and safety con bo served only by keeping such articles out of Interstate commerce: ** ( ) Paint containing lead, except for minute traces which no reasonable man ufacturer could preclude from his prod (secs. 2(f)(1)(B), 2(q) (1) (A), 3(a), "Contains uct, as measured by the atomic absorb- and 3(b), 74 Btat. 372, 374-375 as DrlcU film of this paint may be harmful encc method, intended for interior or amended, 80 Slat. 1304; 15 U.8.C. 1201, If eaten nr chewed. exterior use. and packaged in a form 1262). and the Federal Food, Drug, and Do not apply on toys and other children'* suitable for use in the household as Cosmetic Act (sec. 701, 62 Stnt. 1065-56 as amended; 21 U.S.C. 371), and under authority delegated to him (21 CFR 2.120), the Commissioner proposes that a new subparagraph be added to { UH.5 (a) and that a new subparagraph be articles, furniture, or Interior surfaces of ny dwelling or facility which may be occupied or used by children. Do not apply on those exterior surfaces of dwelling unite, such as windowsills, porches, stairs, or railings, to which children may be commonly exposed. defined by { 101.1(c). Tlic following is tlic statement of grounds as presented in tlic petition: Bt a t f .mb n t o f t h * Gr o u n d s Up o n Wh ic h rmtioNiBa Rm.y t h e Is s u a n c * o f t h e }Pe c u l a t io n added to i 191.7(b), as follows; Keep out of the reach of children." Unman experience has established that 191.5 Product* declared to lie linr.iird- the blank being filled In with the name numerous infants end young rhUdren hats o iii siihsunrea under teclion 5() of tlic act. (a) Tlic Commissioner finds that the following articles are hazardous Btib- of end) heavy metal present in the amount specified in (191.5(a)(2). Interested persons may, within CO days after publication hereof in the Fed er al pica (habitual eating of nonfood substance*). Human experience has also established that ingestion by children of flakes from load bnsed paint causes lead poisoning, tho con sequences of which Include death, encepha stances within the meaning of the act Reg is t er , file witli the Hearing Clerk, lopathy, neuromuscular efTccta. Interference because they arc capable of causing sub stantial personal injury or substantial illness during or as a proximate result of any customary or reasonably foresee able handling or use: Department of Health, Education, and Welfare, Room 6-88, 5GOO Fishers Lane. Rockville, Md. 20852, written comments (preferably In quintupllcatc) regarding this proposal. Comments may be accom with the development of red blood cells, and an abnormal syndrome characterized by colic, anorexia and malaise. DIIEW, PH8, Bureau of Community Environmental Management, "Control of Lend Poisoning In Children.*' Prepubltcation Draft, at I-l (December 10*10). * * * panied by a memorandum or brief in sup It is widely known that the adult system (2) Faint and other surface-coating materials, produced or shipped in Inter- port thereof. Received comments may be seen in tho above ofilco during working absorbs tho dally intake of load at tho rate of 10 percent. Ohleoim, J. Julian, "Scientific American" (February 1971). Thus, assuming State commerce after the effective date of hours, Monday through Friday. the rate of absorption to be the same in FEDERAL REGISTER, VOL 36, NO. 211--TUESDAY, NOVEMBER 2, 1971 X GLD007105 PROPOSED RULE MAKING 20987 children, a child with pica Ingesting 1 gram cl lead based paint (l percent lead by ANSI Standard Z06.1) dally will Intake 10,000 mlcrograma of lead of which 1,000 jnlcrogmws Will be absorbed. In addition t<x direct Ingoutlon by eating flaking paint, a child will be exposed to from H to 260 mlcrograms of lead from other environmental sources. Engel, Ronald E., "Health Hazards of En vironmental bead." at Table 2 (April 107J). It Is known that blood levels of above 40 mlcrograms per milliliters of blood repre sent undue exposure to and absorption of lend. "Hearings on H.U, 17200, H.R. 13254, H.R. 14734, Before the Subcommittee on Housing of the Hour.o Committee on Banking and Currency,** 91st Cong., nocond sess. 10 (1970). At levels of B0 mlcrograms per 100 milliliters a child bo treated as a medical emergency. Id. Whlto Engle In his paper has extrapolated the effect of lead fallout in chil dren with pica, at A 9, the same must be Cone with 1 percent load paint to theorize the roeult In children who Ingest paint flakes. In his study, I>r, Kehoe found that an adult man fed 8,000 mlcrograms of lead dally, In addition to the usual amount In his diet, achieved a blood Ic ac ! level after 4 months of 60 mlcrograms lead per 100 grama whole blood. It was crtlrn&tcd that he would have achieved a "toxic" level ol f!0 mUrnpromu lead per 100 grams whole blood if feeding had continued for 4 additional months, Kehoe, H. A., 24 "Jour. Roy. Inst. J*ub. IMth. Hyg." 01-97, 101, 129-14.7, 177-20.1 (1001). As Engle has asyunicd, tills would be 43 inlorograms per kilogrnm body weight hi a 70 kilogram man. If a child with plea weighing 10 kilograms Ingested lend to the tome degree of Kchoe'a subject, m Engle has suggested, then a proper assurntplon would be that a dally supplement of 430 mlcrograms lead would produce toxicity within 8 months. A child Ingesting a 1 gram chip of 1 percent lead based paint would have a dally intake of almost 24 times the amount of KeHoc's subject. Obivously, Intake at this rate would produce An unduo medical emergency much more quickly than Kehoe foresaw for his subject. Medical experiments cannot be performed on young ohltdren and Infants to determine whether their absorption rale for IcAd Is greater thAn that of adults. The child with pica must be protected from lend In hl en vironment. The only adequate way to protect him Is to eliminate the lead hazards that confront him. It Is within the existing state of the art for the paint Industry to eliminate lend (except for minute traces) from paint. "Hearings on HH. 17200, supra at 246. American* have been lulled Into a feeling of security with regard to today's paints. See F.PA, "Environmental Lead and Public Health/* at 2& (March 1971). Many believe that lead In paint has boon banned. Yet the city of New York has found paints for In terior use with up to 10.8 percent lead levels on shelves of merchants within the last month. Tle New York Times, July 24, 1071, at 1. August 4, 1071, at J8. This despite In dustry's ANSI standard 7.66.1 and a law bnnnlng the sale of paint for Interior use with more than a 1 percent lend content without an adequate warning label. Warning labels are, however, absolutely In adequate to prevent Injury to children from lead based palnta. In today's mobile society a family has no idea what tholr landlord or predecessor occupant has used to coat the walls ol their living quarters. The generation that Is suffering from lead baaed paint poi soning today la eating the walls of the thirties and the forties. The generation that this pro posed regulation seeks to protect la yet un born. Their parents are unborn. It would ba Impossible to substantiate that warning la bels would have any significant impact on th future children of America. Moreover, there is no evidence that existing warning l&bols are efficacious for their Intended pur pose. The parents ol the eighties and the nineties will have no opportunity to read the warning labels of the seventies. It Is not necessary to weigh the advantages of lead based paint ngnlnst the health and v eUarc of this Nation's children and Her future children. The paint Industry can pro duce paint without lead (except for minute traces) ns measured by tho atomic absoibencc method. Petitioner! therefore urge the Commissioner of Food and Drugs to proceed with all duo speed to publish this proposal In the Fed er al Rr.amrR In order that all Interested person! may present their views thereon. Interested persons mfty, within GO days nfter publication hereof In the Fed er al Ri'cisrEn, file with the Hearing Clerk, Department of Health, Education, Rnd Welfare. Room 6-88, 5G00 Fishers Lone, Rockville, Md, 20852, written comments (preferably in quintuplicate) regarding tills proposal. Comments may be accom panied by a memorandum or brief in support thereof. Received comments nmy bo seen in the above office during work ing hours, Monday through Friday. Dated: October 28, 1871. Ch a r l e s C. Ed w a r d s , Commissioner of Food and Drugs. 1FRDOC.71-15BG0 Filed 11-1-71:8:52 am] DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration l 49 CFR Part 566 J (Docket No. 71-11; Notice 31 MANUFACTURER IDENTIFICATION Proposed Motor Vehicle Safety Regulations The puriwse of this proposed amend ment to Part 5GG In Title 49, Code of Federal Regulations, Is to provide lor the coverage of `'Incomplete vehicles", as defined in Part 508, Vehicles Manu factured in Two or More Stages. A previous notice of proposed ruie making published on April 28, 1971 (3G F.R. 7970), proposed a new Part 6G6 that would require manufacturers of motor vehicles and of motor vehicle equipment to wltich a motor vehicle safety standard applies to submit iden tifying information and a description of the items which they produce. A notice of issuance of that part is published In this issue of the Fed er al Re g is t e r , 38 F.R.20977. In responding to a comment from an Incomplete vehicle manufacturer, it was noted that while the proposed regu lation clearly covers intermediate and final-stage manufacturers (as defined in Part 568) It makes no reference to in complete vehicle manufacturers. The proposed amendment Is Intended to clarify this ambiguity by specifically providing for coverage of incomplete vehicles. The Incomplete vehicle manufacturer stated that lie was unaware of the final use of his light truck vehicles mid re quested that he be permitted to submit a brief description of the Incomplete ve hicle expressed in the terminology of the Industry as an alternative to the de scription in terms of final use. This pro posed alternative for incomplete vehicle manufacturers lias been found accepta ble, and the NHTSA accordingly pro poses to grant this request. In consideration of the foregoing the NHTSA proposes that the following amendments be made to Part KGS of Title 49. Code of Federal Regulations: 1. 5 506.4 would be amended to read as follows: 8 566.4 Definition,. All terms defined In the Act and Urn rules and standards issued tinder Its authority are used as defined therein. Specifically, `'Incomplete vehicle", "in termediate manufacturer", and "flnnl- stnge manufacture" arc used as defined in Part 568. Vehicles Manufactured in Two or More Stages. 2. Paragraph (c)(3) of J 560.5 would be amended to read as follows: 5 566.5 lleijuirrnienl,. F.ach manufacturer of motor vehicles, and each manufacturer of covered equipment, shall furnish the informa tion specified In paragraphs (a) through (c) of this section to: Administrator, National Highway Traffic Safety Ad ministration, 400 Seventh Street BW., Washington, DC 20590. ,* (c) (3) In the case of motor vehicles pro duced in two or more stages, if the manufacturer is an incomplete vehicle manufacturer, the description shall so slate and Include a description Indicat ing the stage of completion of the ve hicle and, where known, the tyjies of use for which the vehicle is Intended. F.x a mp ix : truck". "ChRssls-cab"; "van-type If the manufacturer is an Intermediate manufacturer, or a final-stage manufac turer, the description shall so state and include a brief description of the work performed. Emm.i: "Multipurpose passenger vehi cle* : Motor homes with QVWR from 8,000 to 12,000 pound,. Final-stage manulacturer --add body to bare chassis". Proposed effective date: February 1, 1972. Interested persons are invited to sub mit comments on the proposed amend ment. Comments should Identify the docket number and be submitted to: Docket Section, National Highway Traf fic Safety Administration, Room 5221, 400 Seventh Street SW., Washington, DC 20590. It is requested but not required that 10 copies be submitted. . FEDERAL REOISTER, VOL 34, NO. 21 1--TUESDAY, NOVEMBER 2, 1971 GLD007106 3780 NOTICES Bequest* tor t)w> Academy's report: Drug I llicocy Study lu/ormallou Control (BD- C7), Uu t g au of Drugs. * All other oomrruinlctttlonn regarding this ennonnoement: Drug Efficacy Btuily lin- plenientetlon Project Office (BD-00), Bureau of Drugs. 3. The amount, if any, of each of the Hems of lifesaving, firefighting and mis abovo heavy metals that was intention cellaneous equipment, construct ion, and ally added to the product together with, materials used on board vessels subject the reason for such addition; and to Coast Guard inspection, on certain 4. A current label for each analyzed motorboats nnd other recreational ves product. sels, and on the artificial islands nnd fixed . This notice is Issued pursuant to pro visions of the Federal Food. Dmc, and Cosmetic Act (sec. 602, 605, 62 Stat. 1050-53, as (intended; 21 U.8.C. 352, 305) and under authority delegated to tiic Commissioner of Food and Drugs (21 CFR 2.120). Products should be tested for the spec ified heavy metals by any generally ac cepted quantitative method having a sensitivity oi at least 0.01 percent of the metal hi tho contained solids or dried paint film and a reproducibility of plus or minus io percent of the particular metal. structures on the outer Continental Shelf bo of types approved by the Comman dant, U.S. Const Guard. Tlio piuposo of this document is to nnllfy ell interested persons that certain approvals lmve been granted as herein described riming the period from December 28, 1971, t< Jan uary 3. 1072 (List No. 1-72). There ac : Dated: January 28, 1972. The requested data should be submit tions were taken In accordance with the 6a m D. Fin e , Associate Commissioner for Compliance, iva Doc.72-2553 Piled 21-18-72:8:48 ra] ted by April 7, 1972, to the Bureau of Product Safety, 6401 Wcstbard Avenue, Bcthesda, Maryland 20016. Dated: February 17, 1972. ' procedures set forth in 40 Cf lt 2.75-1 to 2.76-50. 2. The statutory authority for equip ment, construction, nnd material ap- piovals is generally sot forth In sections Ch a r l es C, Ed w a r d s , 367. 375. 390b. 410, 481, 489, 520n, and PAINTS AND OTHER SURTACE\ COATINGS CONTAINING HEAVY Commissioner of Food and Drugs. I IB Doc.72-2048 Filed 2-i8-72;8:51 am] 1333 of title 46, United Stntes Code, sec tion 1333 of title 43, United Stntes Cods, and section 198 of title 50, United States ` METAIS , ..... Request for Data Code. The Secretary of Transiwtation DEPARTMENT OF HOUSING AND has delegated authority to the Comman dant, U.S. Coast Guard with respect to In the'Fed er al Rf .c is ib r or Novem ber 3, 1971 (36 F.H. 20985). the Commis sioner of Food and Drugs proposed that DRDAN DEVELOPMENT these approvals (49 CfTt 1.40(b)). The specifications prescribed by the Com mandant, U.S. Const Guard for certain Certain paints nnd other surface-coatings [Docket No. D-72 148) types of equipment, construction, and containing heavy metals be declared haz ardous substances that require special labeling for child protection. In the same AREA DIRECTORS AND DEPUTY AREA DIRECTORS materials are set forth in 46 CFR Parts ICO to 164. 3. The approvals listed in this docu Issue of the Fed er al Rr.r.isTEn (36 F.R. 20980), the Commissioner published a petition submitted by Joseph A. Page et al., proposing to classify as banned haz Redeleyniion of Authority Wilh Re- spccl io Requisitions for Third Party Contracts ment shall be in effect for a period of 5 years from the date of issuance, unless sooner canceled or suspended by proper authority. ardous substances paints which are for Tiic Assistant Secretary for Commu household use and contain more than nity Planning and Management is mlnuto traces of lead. Interested persons amending the redcleaations of authority Bu o y a n t Ve s t s , Un ic e l l u l a r Fo a m Pl a s t ic were allowed 60 days to file written com to Area Directors and Deputy Area Di No t e: For Motorboats of Classes A, 1, or ments legardlng these proposals. rectors (35 F.B. 15408, October 3, 1970) 2 Not Carrying Passengers for Hire. By a letter dated February 2, 1972, to include under the powers set forth Approval Ho. 1C0.052/411/0, Type I, petitioners requested that the Commis in section A.IV.2 the authority to approve Model AP, adult unicellular plastic foam sioner ask paint companies to submit requisitions for third party contracts. buoyant vest manufactured in accord certified analyses of their product lines Accordingly, the redelegatlons of au ance with TJ.8.C.G. Specification Subpart "Cinl order to assist in resolution of the thority published at 35 F.R. 15408 are J00.052, dwg. No. 062-4 dated Decem argument of technical incapacity that amended io add before the period at the ber 27. J 971, and dwg. No. 052-1 dated the paint industry is making ."In end of section A.IV.2 the following December 27,1971, manufactured by Far- consideration of this request and in view phrase: "* and third party con ber Bros,, 821-841 Linden Avenue, Mem of the numerous conflicting and appar tracts". phis, TN 38101, effective December 28, ently irreconcilable comments received in response to the above proposals, the (SccreUry's delegation of authority to the Assistant Secretary for Community rinnnlrg 1971. Approval No. 160.052/412/0, Type I. Commissioner concludes that such data and Management., 38 F.R. 6001, Mar. 16, 1971) Model CPM. child medium unicellular would be of value In preparing the final order. Therefore, tlio Coninii.s.sioner hereby Effective dale. The effective date of this redelcgation Is February 22, 1972. plastic foam buoyant vest manufactured in accordance with U.S.C.G. Specifica tion Subpart 160.052, dwg. No. 052-3 requests that all manufacturers of paint Sa mu e l C. Ja c k s o n , dated December 27, 1971, and dwg. No. and/or other surface-coatings submit the Assistant Secretary for Commu 052-1 dated December 27, 1971, manu following information for their interior nity Planning and Manage factured by Fnrber Bros., 821-841 Lin and general purpose exterior paints and ment. den Avenue, Memphis, TN 38101, effec for those paints and coatings which are supplied to industry for use on toys nnd other children's articles as well as furni ture and other household articles which may be accessible to children; [FR Doc.72-2611 Filed 2-18-72:8:51 ami DEPARTMENT OF tive December 28,1971. Approval No. 160.052/413/0, Type I, Model CPS, child small unicellular plas tic foam buoyant vest manufactured In accordance with U.S.C.G. Specification 1. The total amount of each of the heavy metals lead, antimony, arsenic, TRANSPORTATION Subpart 160.052, dwg. No. 052-2 dated December 27, 1971, and dwg. No. 052-1 barium, cadmium, mercury, and selen ium (all calculated as the metal) pres Coast Guard dated December 27, 1971, manufactured by Farber Bros., 821-841 Linden Avenue. ent in the contained solids or dried paint ICOFR 72-201 Memphis, TN 38101, effective Decem film together with identification of the quantitative method used for such determination; 2. If barium is present, the percentage of the total barium which Is water sol uble barium (calculated as the metal); EQUIPMENT, CONSTRUCTION, AND MATERIAIS Approval Notice 1. Certain laws and regulations (40 CFR Chapter I) require that various ber 28,1971. Hy d r a u l ic a n d Ma n u a l Re l e a s e s t o r Lif e s a v in o Eq u ip me n t Approval No. 160.062/3/0, Model S880 hydraulic and manual release for lifesaving equipment, for buoyant loads . FEDERAL REGISTER, VOL 37, NO. 35--SATURDAY, FEBRUARY IV, TV72 GLD007107 N 2260.03 RULES AND REGULATIONS 5229 composition and labeling prescribed by t 27.163 lor orange drink except that: (a) The name ol the beverage base consists of the following two phrases which shall appear together: <1) Tin-, word "Powdered" or any ap propriate descriptive word used in lieu of the word "Powdered" which shall be on a line Immediately above the words "Orange Drink." (2) The words "Containing----- Per cent Orange Juice" which shall have lire blank filled in with the number 10 or a number which is a multiple of 6 higher than 10 but not higher than 30 or greater than lire percentage of equivalent single strength orange Juice in a beverage made by reconstituting the powdered base as directed on the label. (b> Safe and suitable antlcaking agents, foaming agents, browning in hibitors, and drying agents may be added. 27,166 Orange flavored drink; iden tity; label statement of o]>linnnl in gredients. Orange flavored drink is the bevernge that conforms to nil of the requirements for composition and labeling prescribed by } 27.168 for orange juice drink except that: (a) It contains less titan 10 percent but more than 0 percent equivalent single strength orange Juice calculated ns set forth In 5 27.158(d)(2) of (his chapter. This requirement is considered to liave been met If the content of orange juice soluble solids (exclusive of soluble solids other titan orange Juice soluble solids) amounts to less than 1.18 percent but move than 0 percent by weight of the finished beverage. (b) Tlte orange Juice soluble solids re quirements for orange flavored drink may be contributed solely by one or more of the orange juice ingredients described in 5 27.158(b) (1) through (11). (c) Tlte weight or the total soluble solids is not less than 10 percent by weight of the finished beverage. <d> Tlte name of tlte beverage con sists of tlte following two phrases which shall appear together: (1) The words ``Orange Flavored Di ink" which shall be printed on a single line. (2) Tlie words "Containing___ per cent Orange Juice" which shall have the blank filled in with tire words "less than 2" if the beverage contains less than 2 percent but more than 0 percent orange juice or with the number 2 or a number which is a multiple of 2 higher than 2 but not higher than 8 or greater than the percentage of equivalent single strength orange juice contained in the finished be verage. 27.167 Coiirrn(r(r fur iirmtpi- fla vored drink ; ideniilv ; label vlniement of optional ingredients. Concentrate for orange flavored drink is the beverage concentrate which, when diluted according to label directions, con forms to all of the requirements for com position and labeling prescribed by I 27.166 for orange flavored drink except (a) The name of the concentrated Effective date. Tills order shall become beverage base consists of the following effective 180 days after its date of publi two phrases which shall appear together: cation in the Fed er al Reg is i er , except f s (1) 'lire words "Concentrate for" to any provisions that may be stayrd by which shall be on a single line immedi the filing of proper objections. Notice of ately above the words "Orange Flavored the filing of objections or lack thereof Drink." will be given by publication in the Fed (2) The words "Containing___ per er al Reg is t er . cent Orange Juice" which shall have the (Sec*. 401, 701. 52 Stilt. 1010, 1065-58 as blank filled In with the words "less than amended by 70 8tat. 019 and 72 Stat. 910; 21 2" nr with the number 2 or a number U.8.O. 341, 371) which is a multiple of 2 higher tlinn 2 but not higher than 8 or greater limn the Dated: March 7, 1972. percentage of equivalent single strength Ja mb s D. Gr a n t , orange Juice in ft beverage made by dilut Deputy Commissioner ing the beverage concentrate as directed o/ Food and Diups. on the label. (b) The dilution ratio of the beverage |PR Doe.72-3706 Filed 3-10-72;B:M am] shall not be less than 3 plus 1, For the jnir()ose of tills section the "dilution SUBCHAPTER D--HAZARDOUS SUBSTANCES ratio" is the whole number of volumes of water per volume of concentrate for orange flavored drink required to produce PART 191 --HAZARDOUS SUB STANCES: DEFINITIONS AND PRO orange flavored drink conforming to the CEDURAL AND INTERPRETATIVE requirements for composition prescribed REGULATIONS by $ 27.166. CI a is i fication of Certain Lead- 27.1611 Powdered orunge flavored Containing Points and Other Sim drink; identity: hdiel Mntrinrnt of optional ingredients. Powdered orange flavored drink is ttic ilar Surface-Coaling Materials as Banned Hazardous Substances dehydrated beverage base which when In the matter, of classifying certain reconstituted according to label direc lead-containing paints and other sur tions conforms to all of the requirements face-coaling materials as banned haz for comiiositlon and labeling as pre ardous substnnees: scribed by ( 27.166 for orange flavored In the Fed er al Reg is t er or Novem drink except that: ber 2, 1971 (36 F.R. 20985), the Commis (a) The name or tlte beverage base sioner of Food and Drugs published a consists of tlte following two phrases notice proposing to declare, under section which shall appear together: 3<a) of the Federal Hazardous Pub- (1) The word "Powdered" or any ap stances Act. paints and oilier surface- propriate descriptive word used in lieu of coaling materials containing more than the word "Powdered" which shall be on a specified levels of lead and other named lino immediately nlxive the words heavy mrtals to he hazardous substances "Orange Flavored Drink." (5 191.5(a)(2)) and to be products re (2) The words "Containing___ per quiring special labeling under section cent Orange Juice" which shall have the 3(b) of tlie act <5 101.7<l (70. This is blank filled In with the words "less than referred to below ns tlie Commissioner's 2" or with tlie number 2 or a number proposal. which Is r multiple of 2 higher titan 2 but not higher than 8 or greater than the percentage of equivalent single strength orange juice In a beverage made by re constituting the powdered base as di rected on tlie label. (b) Safe and suitable antlcaking agents, foaming agents, browning inhib itors, and drying agents may be added. Any person who will be adversely af fected by tlie foregoing order may at any time within 30 days nrtor its date of pub lication in the Fed er al Reg is t er Ale with tlie Hearing Clerk, Department of Health. Education, and Welfare, Room C 88. 6C00 Fishers Lane, Rockville, Md. 20852, written objections thereto. Ob jections shall show wherein the person filing will be adversely a fleeted by the .l In the same issue of the Fed er al Reg is t er (36 F.R. 20986). a notice was published on behalf of petitioners Joseph A. Page et al., which proposed that paint for household use containing more than minute traces of lend be classified as a banned hazardous substance pursuant to sections 2(g)(1)(B) and 3<n)(2) of tlie net. This is referred to below as the Pane proposal. Approximately 200 comments were re ceived from consumers, consumer and public interest groups, tlie paint and chemical industries, trade associations, physicians, medical schools, professional societies, Federal, State, and local gov ernment agencies, and others. The prin cipal comments are as follows: order and specify with particularity the Tire American Academy of Pediatrics, provisions of ttie order deemed objec relying on published studies with lend tionable and the grounds for the objec and data respecting the maximum dally tions. If a henring is requested, the ob permissible Intake or lend from ail jections must state tlie issues for the sources, recommended that paints con hearing and such objections must be sup taining more than 0.06 percent of lead be ported by grounds legally sufficient to banned if Intended for use on Interior justify the relief sought. Objections surfaces, toys, or other children's articles. may be accompanied by a memorandum The Academy agreed with the Commis or brief iti support thereof. All docu sioner that small amounts of lead In ments shall be filed In six copies. paints when considered In conjunction REGISTER, VOL JZ, NO. 49--SATURDAY, MARCH 11, 1*72 GLD007108 N 2260.04 :'5230 .-v**- RULES AND REGULATIONS 5"2-SO with other soiuccs of lead In the environ lead paints, while othcra suggested that / compounds other than lend nre not haz ment constitute a substantial addition to lead paints for Interior use lie banned J ardous, while others stated that adequate ttio body burden that can reasonably be and that cautionary labeling be required \ test methods need to be developed. An avoided and that any unnecessary ex for other lend paints. Comments from j' other manufacturer stnted that certain of posure should be eliminated or mini the public health departments for the > these heavy metals are necessary In the t mized. It also stated that the labeling of cities of Philadelphia and New York 1 manufacture of flre-rclardnnt coatings 1 paint containers would have little cfTcr-t slate (lint the labeling ordinances and ' and warning colors. Only a few other in preventing lead poisoning and that regulations of their cities, which nre comments were received that expressed paint containing 0.5 percent lead will not similar to those In the Commissioner's nn opinion concerning the Commis provide sufficient protection lor children proposal, have been inadequate to pro sioner's proposal ns It related to other 1 to 3 years of age. The Academy tect children. Both tho American Public heavy metals, and none of these were stated that it is estimated that approx Health Association and the health de supported by scientific data. imately 50 percent of these children partments for the State of New York and The Commissioner, having considered repetitively ingest nonfood substances the county of Los Angeles support the the comments and other relevant ma and that abdominal X-rays obtained in reroniinetuialion of the American Acad terial, concludes ns follows: the. dlivanuslic evaluation of children sus emy or Pediatrics. Some comments sug Although paints and other surfacepected of having lead poisoning Indicate gested other maximum levels for lead in coating materials containing lead do not that very large quantities of foreign sub paint. For example, the Congressional picsent an imminent hazard to tho pub stances such ns paint, putty, and plaster BlRck Caucus recommended that all lead lic health, they must be considered on may be Ingested, often without the par from household paints be banned; the the basis of cumulative toxicity over ex ent's awareness. Natural Resources Defense Council and tended perlofls of time and In conjunc The Bureau of Community Environ the Department of Public Health of the tion with other sources of lend In the mental Management, Health f5crvlc.es city of Philadelphia recommended 0.05 environment. Based on tho currently and Mental Health Administration, De percent ns a maximum level for lead In available sciontl fie and medical data, reg partment of Health, Edurntion, mid Wel paint. ulatory action must be taken to minimize fare, commented that cantiomu y labeling r;dnt chondral manufacturers and the health hazard to future generations. does not provide adequate protection, that the nvallahlllly of lead in paint to children should he held to the lowest concentration possible with current tech nology and consistent with reasonably good manufacturing practices, and that the maximum concentration of lead in paints intended (or use on Interior sur faces readily available to children should not exceed O.Ofi percent. their trade associations generally sup ported the Commissioner's proposal and opposed the Page proposal. With respect to the Commissioner's proposal, several comments requested clarification of the labeling statement and sufficient time to reformulate nnd relabel their products. With respect to the Page proposal, many comments slated that the language ``minute traces of lead" is vague nnd Tlu* health hazard from lead will not be effectively eliminated by cautionary labeling requirements. The statute docs not provide that such labeling must be tried and proven Inadequate before ft hazardous substance can be banned. In stead, section 2(q) (1) (B) explicitly pro vides for banning products from inter state commerce on the basis of n specific boding "notwithstanding such caution The Environmental Protection Agency nonspecific; that the data relied on by ary labeling ns Is or may be required." submitted an tn-liouse technical rojtort the petitioners nnd by the American Cnutionary labeling has not been proven which concluded that lead In pntnt in Academy of Pediatries Is based on lead effective in eliminating lead poisoning excess of 0.P5 percent could constitute a ingestion studies done with lead com in many cities which presently have such danger to the health of children with pounds other than the lead compounds requirements. In any event, the hazard pica. They slated that cautionary label used in paints and coalings; that scien persists long after the product has been ing would be inadequate to protect tho tific data or human cxpo.rience has not separated from its labeling. public health and safety and recom mended that lead-based paint be banned from interstate commerce. The medical community generally en dorsed the Page proposal and supported tho recommendation of the American Academy of Pediatrics. Some physicians from medical centers located In large metropolitan areas submitted the results of their own clinical findings and studies which Indicate the hazard posed by lead in paint. Other physicians cited studies which indicate that children can accu proven that paints containing 1 percent lead are hazardous: that lend is used as a dryer and the substitution of other compounds for lead may be hazardous; and that Implementation would cause a severe economic hardship because It Is not within the existing state-of-the-art of tho paint industry to eliminate all lend lrnm all paint. Several comments con tended that the statutory procedures for banning have been Ignored in the Pngo proposal in that only after labeling has been proven Inadequate can considera The prudent course of action is lo re duce, ns rapidly as possible, the amount of lead to which children arc exposed. The Commissioner agrees that limiting the amount of lead to "minute traces," ns set forth In the rage proposal. Is not feasible because tbnt phrase is vague and would not provide manufacturers with specific standards, and it could not be effectively enforced by the Pood and Dmg Administration. In addition, limit ing regulatory action only to paint Is inadequate to protect the public health mulate toxic levels of lead over an ex tended period of time from paints con taining 0.5 percent or less lead. Two physicians cited cases of children with tion be given to banning. Other com ments stated that warning labels nre adequate protection because they pre vent misapplication of paint products and safety because other surfacc-coating materials containing lead are used in and around the household and are accessible to children. excessive body burdens of lead which they could attribute only to paint con taining less than 1 percent lead. The medical community generally com mented that the labeling proposed by the . Commissioner would not provide ade quate protection liecause subsequent oc- and serve the public Interest by allowing useful, needed paint products to remain on the market. Some comments stated ttiat lead Is ft necessary component of certain products (c.g., certain exterior primers, rust Inhibitors, and automobile touchup paint). The preponderance of medical opinion supports a regulation limiting tho amount of lead In products Intended for interior surfaces and for toys or other children's articles to 0.06 percent because that level will provide a margin of safety. However, such a regulation would not eupnnts of dwellings would not know A number of paint manufacturers and prevent the use of products containing what paints were applied by previous their trade associations commented that higher amounts of lead on exterior sur residents and because labeling may be the Inclusion of heavy metals other than faces. These surfaces are generally r s ' totally disregarded or misinterpreted. lead In the Commissioner's proposal is accessible to children as Interior surfaces, Nearly all comments from consumers, Inappropriate. They stated that the tox and, as the comments points out, chil consumer and public interest groups, end icity of different forms of these metals dren hare been subjected to lead poison- Government agencies (other than those has not been established and suggest i lng by ingesting products containing lead discussed above) endorsed the Page pro . that action be deferred pending further ! that acre applied to exterior surfaces.- posal. Some stated that the Commis | scientific Investigation. Borne manufae- \ in addition, if products containing lead sioner's proposal would not provide suffl- turera submitted data which they eon- are available for exterior use, they may - dent protection against Interior use of /*I tend shows that certain heavy metal | be misused for Interior surfaces. I FEDERAL REGISTER, VOt, 27, NO. 49--SATURDAY, MARCH 11, 1972 GLD007109 RULES AND REGULATIONS 52.11 Thu Commissioner recognizes that re- I[elements, other thnn lead. In paint ftiidj thereto. Objections shall show wherein stvlctlons placed upon the use of lead j other surface-coating materials. Addi-| the person filing will be adversely af may result In economic hardship and In tlonal data on the use of these materials fected by tho order and specify with par the substitution of other components for' will be obtained in response to the Fed ticularity the provisions of the order use as dryers. The statute makes no ex er al Rec is t er notice of February 19. deemed objectionable and the grounds ception lor economic hardship. Several 1972 (37 F.R. 3780), and these products for flic objections. If a hearing is re compounds have been suggested ns sub will be considered nt a later date. quested, the objections must state the stitutes for lead. Each manufacturer, Therefore, pursuant to provisions of Issues for the hearing and such objec prior to marketing consumer products, the Federal Hazardous Substances Act tions must be supported by grounds must take steps to determine that any (secs. 2 (f)(1)(A), (q); 74 Stat. 372, as legally sufficient to Justify the relief substitute for lead has been adequately amended, 80 Stnt. 1304-05; 15 U.S.O. sought. Objections may be accompanied tested for safety and shown to be safe. 1201 (f)(1)(A), (q)) and the Fedcrnl by a memorandum or brief in support Any banning order should therefore pro Food. Drug, and Cosmetic Act (sec. 701 thereof. All documents shall be filed in vide a reasonable time to test substitutes (c). (f), (g); 52 Stnt. 1055-50 as six copies. Received objections mny be for lend and establish their snfrty, and nt emended by 70 Slat. 919 and 72 Slat. seen in the above office dining working the same time provide adequate protec 948; 21 U.S.C. 371 (e), (f), (g)), and hours, Monday through Friday. tion to the public. Tli National Paint and Coatings As sociation, which represents more than 000 companies, has notified the Commis sioner that it anticipates Us members cau produce by January 1974 interior products not exceeding the 0.06 i>crcent maximum lend level and con produce hy January 1975 exterior products not ex ceeding the 0.06 percent maximum lead level. Sonic paint and chemical manu facturers have notified the Commissioner that they can reformulate their products to meet the 0.0C percent maximum lead level In a shorter time period. On Feb under authority delegated to tho Com missioner (21 CFR 2.120): It is ordered. That Part 191 be amended by adding a new subparagraph (6) to 1191.9(a), as follows; 191.9 Hunned linznrdoii* fciihMmices. ( ) Under the authority of section 2(q) (1) (ID of the act, the Commissioner declares ns banned hazardous substances the following articles because they pos sess such a degree of hazard that ade quate cautionary labeling cannot be writ ten and the public health end safety can be served only by keeping such ar Effective date. Tills order shall brrome effective 46 days after Us dale of publi cation in the Fed er al Re g is t e r , except as to any provisions that may be stayed by the filing of proper objections. Notice of the filing of objections or lack thereof will be given by publication in the Fed e r a l Re g is t e r . (Secs. 3 (f)(1)(A), (q), 74 Stat. 372, as amended 80 Slat. 1304-05, 16 U.S.O. 1201(f) (1) (A), (q): ec c . 701 (e), (f), (g), 52 Slat. 1055-60 as nmriuled by 70 Slat. 919 and 73 Stat. 943; 21 U.S.C. 371 (e), (f). (g)) Dated: March 8,1972. ruary 19, 1972. a notice was published ticles out of interstate commerce: Ja me s D. Gr a n t , in the Fed er al Reg is t er (37 F.R. 3780) * * Deputy Commissioner requesting that additional information ( ) (i) Any paint or other similar of Food and Drugs. from the industry be submitted by April 7, 1972. If, after considering this infor mation, the Commissioner finds that lead can be eliminated from paints and other surface-coating materials more rapidly than the implementation dates specified in the following order, an appropriate amendment will be made. Therefore, the Commissioner finds that, notwithstanding such cautionary surface-coating material intended, or packaged In a form suitable, for use in or around the household that: (a) Is shipped In Interstate commerce nfter December 31, 1973, and contains lead compounds of which the lead con tent (calculated as the metal) Is in ex cess of 0.00 percent of the total weight of the contained solids or dried paint film; or |pn Doc.72-3760 Piled 3-10-72; 19:30 p.m.| Title 2G--INTERNAL REVENUE |TX>. 7187| Chapter I--Internal Revenue Service, Department of the Treasury labeling as Is or may be required under the Federal Hazardous Substances Act, the degree or nature of the hazard In volved in the presence or use of lead In paints and other surface-coating ma terials in households Is such that the objective of the protection of the public health and safely can be adequately served only by keeping such substances, <b) Is shipped In Interstate commerce between December 31, 1972, and Decem ber 31. 1973, and contains lead com pounds of which the lead content (cal culated ns the metal) Is In excess of 0.5 percent of the total weight of the con tained solids or dried paint film. (II) Any toy or other article Intended for use by children that; SUBCHAPTER A--INCOME TAX PART 1--INCOME TAX; TAXABLE YEARS BEGINNING AFTER DECEM BER 31, 1953 Rehabilitation of Low-Income Housing On August 4, T970. notice of proposed rule making with respect to the amend 1w hen so intended or packaged, out of the ({Channels of interstate commerce. Under A section 2<q) (1) of the act, this will have V the additional eftect of banning such | products from use on any toy or other r article intended for use hy children. (a) Is shipped In Interstate commerce ment of the Income Tax Regulations (26 after December 31, 1973, and bears anyCFR Part 1) to conform the regulations paint or other similar surface-coatingto tire provisions of section 521(a) of the material containing lead compounds ofTax Reform Act of 1969 (83 Stnt. C51). which the lead content (calculated as therelating to rehabilitation of low-income motal) Is In excess of O.Ofi percent of thohousing, was published in the Fed er al Since lead may be a necessary com total weight of the contained solids orReg is t er (35 F.R. 12400). After consider ponent of products intended for par dried paint film; or ation of all such relevant matter ns was ticular uses, as suggested by several com (h) Is shipped in interstate commerce presented by interested persons regard ments. the Commissioner Is prepared to between Decenilmr 31, 1972, and Decem ing the rules proposed, the amendment consider petitions proppslng amendment ber 31. 1973, and bears any paint or of the regulation. Pursuant to 21 CPU other similar surface-coating material 191.201, petitions showing reasonable containing lend compounds of which the grounds will be published In the Fed er al lead content (calculated ns the metal) is Reg is t er . Consideration will also be In excess of 0.5 percent of the total given in late 1973 to petition.'; for exten weight of the contained solids or dried sion of the implementation date upon a paint film. showing that the public health will not Any person who will be adversely af be jeopardized and that technological fected by the foregoing order may at any necessity requires additional time to time within 30 dayr after its date of pub meet the 0.06 percent maximum lead lication in the Fed er al Re.g is t er file with level. , the Hearing Clerk, Department of ns proposed is hereby adopted, subject to the changes wliicli follow: Sections 1.167(k)-l through 1.167(k)--4 are re vised to read as set forth below. (Sec. lG7(k). Internal Revenue Code of 1951, 83 Slat. 651; 28 U.S.O. 187; see. 7805, Internal Revenue Code oX 1054, <J8A Slat. 917; 20 U S C. 7805) [s e a l ! Jo h n n ie M. Wa l t e r s , Commissioner of Internal Revenue. Approved: Mnrch 2,1972. . At thts time, further information Is 1 Health, Education, and Welfare, Room qrequired before a final order can be pin I G-88, 5600 Fishers Lane, Rockville. Fr e d e r ic W. Hic k ma n , Acting Assistant Secretary 'd mulgatcd regarding tho use of certain (Maryland 20852, written objections of the Treasury. FEDERAL REGIS1ER, VOL J7, NO. 49--SATURDAY, MARCH A G LD 00 7110 16078 RULES AND REGULATIONS UO'TS (1) Ho.suits of tests and assays on: mlllllltcr volumetric flask. Add about 60 which the lend content (calculated as the (a) The grlseofulvln used In making milliliters of methyl alcohol to the flask. metal) is In excess of 0.06 percent of the the batch for potency. safety, Io m on Warm tile contents by heating the flask tola) weight of the contained Solids or drying, melting point, specific rotation. carefully over a steam bath. Ewlrl the the dried film. Finally, the order specifi Identity, residue on Ignition, heavy contents several times during the heat cally provided, as required by section metals, specific surface area, and ing period. Shake the flask on a me 2(q)(l)(A) of the act, that any toy or crystallinity. chanical shaker for 15 minutes, allow other Rrllcle intended for use by children <b) The batch for potency and pH. to cool to room temperature, and ad bearing such paint and otlior similar (li) Samples required: just to volume with methyl alcohol. Mix sur/nre-contlng materials after those re fa) The grlseofulvln used In making well. Filter the solution, discarding the spective dates would also be a banned the batch: 10 packages, each containing first 10 to 15 milliliters of filtrate. Trans hazardous substance. not less than 1 grain. fer exactly 1.0 milliliter of the subse Pursuant to section 2(q) (2) of said act (b) The batch: A minimum of 5 Im quent filtrate to a EO-millillter volumet and section 701(e) of the Federal Food, mediate containers. ric flask, adjust to volume with methyl Drugs, and Cosmetic Act, 30 days wore fb) Tests and methods of assay--(1) alcohol, and mix well. Using a suitable provided for filing written objections and Potency. Use either of the following ultraviolet spectrophotometer and requests for heal ings. methods; however, the results obtained matched 1 centimeter quart?, cells, set Twenty-five timely submissions were from the microbiological agar diffusion the Instrument to 100 percent transmis received with respect to this order. Al assay shall be conclusive. sion with methyl alcohol. Determine the though some of these submissions related <1) Spectrophotomctric assay. Proceed as directed In f 148g.l(b) (1) <1>, except prepare the sample for assay as follows: Prepare a 0.60 milligram per milliliter solution (estimated) of the suspension by transferring an appropriate volume absorbance of the sample and working standard (prepared as described In 1148g.l(b) (1) (1) (n)) at the absorption peak at 292 2 nanometers. Calculate the milligrams of grlseofulvln per milli to the 0.5 percent lead level to be imple mented as of December 31. 1973, the majority of the submissions were con cerned with the 0.06 percent lead level to be implemented December 31, 1973. The Commissioner finds that these two of the well-shaken suspension to a 100- liter of sample as follows: different levels and effective dates pre sent separate and distinct Issues thnt re Milligrams of grlseofulvln , Absorbnucc of Weight of standard In Potency of standard __s_a_mple __ y _ milligrams y -..g..r.n.ms per milligram in mirro- per milliliter Absorhniice of' Milliliters of suspen- 1.000 standard slon tested quire separate consideration. Accord ingly. this document rules only upon the submissions made with respect to the 0.5 percent lead level to be Implemented as of December 31, 1972. A future docu (11) Microbiological agar diffusion as say. Proceed as directed in 5 Hi.110 of SUBCHAPTER E--HAZARDOUS SUBSTANCES |Docket, No. FDC HS-21 ment will rule upon the submissions with respect to the 0.06 percent lead level to be implemented as of December 31, 1973. tills chapter, preparing the sample for assay as follows: Dilute an accurately measured volume of the well-shaken sus pension with sufficient dlmcthylforma- mlde to give a stock solution containing 100 micrograms of grlseofulvln per mil PART 191---HAZARDOUS SUB STANCES: DEFINITIONS AND PRO CEDURAL AND INTERPRETATIVE REGULATIONS Certain Lead-Containing Paints and The majority of the submissions en dorsed the 0.5 percent lead level to be Implemented as of December 31, 1972. The National Paint and Coatings Asso ciation previously endorsed this level in a letter to the Commissioner dated Feb ruary 2, 1972, and the submission of the liliter (estimated). Further dilute with Other Similar Surface-Coating Ma New York Paint, Varnish, nnd Lacquer 0.1M potassium phosphate buffer, pH 8.0 (solution 3). to the reference concen tration of 6.0 micrograms of grlseofulvln per milliliter (estimated). (2) pH. Proceed as directed In 9 14J terials as Banned Hazardous Sub stances; Confirmation In Part of Ef fective Date of Order In the matter of classifying certain lead-containing paints and other sut- Association and the submission of the Federation of Societies for Paint Tech nology supported this provision. McOloskcy Varnish Co. objected to I he 0.5 percent lead level but failed to sub mit supporting grounds and In any event 503 of this subchapter, using the un face-contlng materials ns banned haz did not request a public hearing on their diluted suspension. Data supplied by the manufacturer concerning the safety and efficacy of the subject antibiotic drug have been eval uated. Since the conditions prerequisite to providing for certification of this drug have been complied with and since the matter Is not controversial, notice and public procedure and delayed effective date are not prerequisites to this promul gation. ardous substances (21 CFR 191.9(a) (6)) within (he meaning of section 2(q) (1) of the Federal Hazardous Substances Act: In the Fed er al Reg is t er of March 11, 1972 (37 F.U. 5229), the Commissioner of Food and Drugs published an order under section 2(q) (1) (B> of the said act declaring paint and other similar sur face-coating materials for use In or nround the household to be a banned hazardous substance If shipped in Inter state commerce after December 31, 1972, objections. Other submissions protested the 0.5 percent level but did not submit formal objections or request a public hearing. Precision Paint Corn, requested an additional 6 months to comply with the 0.5 percent level but did not submit formal objections or request a public hearing. The National Decorating Products As sociation and Benjamin Moore ti Co. sub mitted objections nnd a request for a public hearing with respect to the 0.5 percent lead level on the ground that Effective date. This order shall be ef containing lead compounds of wldch the the time for compliance should be ex fective upon publication in the Fed er al lead content (calculated ns the metal) tended 18 months for retailers and dis Reg is t er (8-10-72). Is In excess of 0.6 percent of the total tributors. The National Retait Hardware (Bee. 507, 59 Stat. 463, as amended; 21 U.S.C. weight of the contained solids or the Association submitted, an objection on 357) dried film. Separate provisions of that this Issue but did not request a public Dated: August 2,1972. H.E. Simmo n s , Director. Bureau of Drugs. order also banned shipment In interstate commerce after December 31, 1973, of paint and other similar Burfnce-coatlng materials for use In or around the house hearing. Two other submissions objected on the ground that the 0.6 percent lead level offers no relief since those products would be banned and subject to repur [FR Doc.72-12601 Filed 8-9-72:8:40 am] hold that contains lead compounds of chase when thi 0.06 percent lead level FEDERAL REGISTER, VOL 37, NO. 155---THURSDAY, AUGUST 10, 1772 GLD007l t i N 2260.05 RULES AND REGULATIONS 1G079 becomes effective. but uo public hearing request for a public hearing Is with effective date of all but subdivisions was requested on that Issue. drawn. Accordingly, since no other party <l)(a) and (ID (a) of 1101.9(a)(6) be Tho Commissioner lias evaluated tlie objeotion and request for public hearing requested a public hearing on any Issue that is being granted, tho Conimissionor came effective April 25, 1972, and tljftt a document ruling upon subdivisions by tho National Decorating Products As concludes that a public hearing will not (i) (a) nnd (ii) (a) will bo published at a . sociation and Benjamin Moore fc Co. end be held on the matter. later time. concludes tlrnt they are not supported by Professor Joseph A. Page et al. of the grounds legally sufficient to justify tlie Georgetown University Law Center ob Dated: August 4, 1972. relief sought. Neither submission con tended that the lead content or paint should not be reduced to 0.5 percent to reduce the health hazard to children. Both submissions contended only that jected to the 0.5 percent lead level in sofar as it disregards the repurchase provisions of section 15 of the act and insofar ns It permits an additional year to meet the 0.0G percent lead level. Since Sa m D. Fin e , Associate Commissioner tor Compliance. [FR Doc.72 12602 Filed 8 -9-73;8:4S snij retailers and distributors should have an additional 18 months to dispose of exist ing Inventories. No information was sub mitted to show that it will take an addi tional 18 months to dispose of existing Inventories, or that such nil extension section 15 of tho net applies to all banned hazardous substances nnd Is In nny event not enforceable by the Commissioner under the act, it would be Inappropriate to make any provision with respect to repurchase in this or any other regula Title 43 - PUBLIC LANDS: INTERIOR of time would not be utilised to over stock noncomplylng paint in order to avoid the regulation. Tlie ret contains no provision authorizing the Commis tion relating to a banned hazardous sub stance. The net also explicitly permits tire Commissioner to establish appro priate Implementation dates. The Com Subtitle A--Office of Ihe Secretary of the Interior PART 19--WILDERNESS sioner to grant an exemption for retailers missioner concludes that the objections end distributors to cell existing invento arc not supported by grounds legally PRESERVATION ries that fall to conform to applicable sufficient lo justify a public hearing, and Hearing Procedure* regulations, and Indeed nny such provi sion would clearly violate the law. ltctailers nnd distributors have known since March 11, 1972, tlmt further Interstate shipment of household paint containing more than 0.6 percent of load would be unlawful, nnd have therefore had sufflclent opportunity to eliminate noncon forming paint from their inventory. Sub In im.v event the Page submission states that no puhlic hearing is requested on these matters. Two submissions were made after the statutory time for objections had ex pired. One of these, submitted by Ameri can Home Froducts Corp., objected generally to the order as not providing adequate support for the severity of the 43 CFR Part 19 was contained in Cir cular 2203, 31 F.R. SOU, February 22, 1966. Paragraph 19.5(a) Ls amended as fol lows: In the third sentence of | 19.6(a) substitute tlie figure "30" for the figure "CO". Because this amendment relates to missions to the Commissioner In response to his request published In tlie Fed er al Reg is t er of February 19, 1972 (37 F.R. 3780), with respect to the present lead content of paint, demonstrate that them Is already a sufllrient supply of household limitations established and requested a heaving to resolve tho lep.nl issues rnised by the absence of supporting data for tlie order. Since tlie American Home Prod ucts Corp submission failed to specify with particularity the provisions of the lntemnl wilderness area administrative procedures, notice and public procedure thereon is deemed unnecessary, and this amendment will become effective upon publication tn the Fed er al Reo is t er (8-10-72>. paint meeting tlie 0.6 percent lead level order deemed objectionable nnd the to satisfy all existing needs. Accordingly, grounds for tho objections, requested a since the act does not provide for nn healing to resolve legal Issues, and failed extension of time for retailers and dis to slate n factual basis sufficient to Ha r r is o n Loescit, Assistant Secretary ot the Interior. Au g u s t 4, 1972. tributors to sell existing Inventories, the justify a public hearing, nnd In view of (FR DOC72-12523 Filed 8-9 7Q;8'.4S am) Commissioner concludes that the objec the fact that tho submission was not tions submitted by the National Decorat made within the statutory time period, ing Products Association and Benjamin tlie Commissioner concludes that this Chapter II---Bureau of Land Manage Moore fc Co. are legally insufficient to submission does not require a public ment, Department of the Interior Justify a public hearing on this matter. lien ring. The Commissioner therefore denies this Tlie order promulgating i lBl.9(n) (6) APPfNOIX-- PUBLIC LAND ORDERS request for a public hearing. in tlie Fed er al Reg is t er of March 11, (Public Land Order 6244] Borden, Inc., objected to the 0.5 per cent lead level on the ground that there Is no substantial evidence that adequate rautlonary labeling cannot be written, 'fids submission did not contend that the lead content of paint used In or around a household should not be re duced to 0.6 percent to reduce the health hazard to children. Since the submis sion presented no basis whatever to show } j 1 that cautionary labeling will prevent the use of lead-based paint In or around a household (for example, particularly a household where children presently do not live), nnd since there Is obviously no way to require cautionary labeling on walls pnlnted with lead-based paint so that future occupants will be aware of the potential hazard, the Commissioner concludes that this objection is not sup ported by grounds legally sufficient to 1972 f37 F.U. 6229), stated that it would become effective 45 days thereafter unless stayed by the filing of proper ob jections. This effective date is not to be confused with the implementation dates contained in the regulations. In view of the Rbove findings, the,J Commissioner concludes that those por-V tlons of S 191.9(a)(6) pertaining to the; 0.5 percent lead level should he confirmed' ns effective. Those portions pertaining to the 0.00 percent Jead level will be tlie subject of a separate document to be published at a later date. Therefore, pursuant to provisions of the Federal Hazardous Substances Act (secs. 2(f)(1)(A), (q>, 74 Stat. 372, 374, as amended 80 Stat. 1304-1305; 15 U.S.C. 1261(f)(1)(A), <q)) and the Federal Food, Drug, and Cosmetic Act (see. 701 (c>. ), (g), 62 Stat. 1055-56, as (Nevada 6020] NEVADA Withdrawal of Lands for Air Navigation Site By virtue of the authority contained in section 4 of the Act of May 24, 1928, 49 U.S.C. section 214 (1970), it is ordered as follows: 1. Subject to valid existing rights, the following described public land, which is under the jurisdiction of the Secretary of the Interior. Is hereby withdrawn from all forms of appropriation under the pub lic land laws. Including tlie mining laws, 30 U.S.C. Ch. 2. but not lrom leasing under tlie mineral leasing laws, and re served for use by the Federal Aviation Administration, Department of Trans justify a public hearing on tlie Issue. In amended by 70 Stat. 919 and 72 Stat. 048; portation, os an air navigation site: any event, tlie Borden submission states 21 U.S.C. 371 <c), (f), (g)), and under Mo u n t Dia b l o Mt r io ia n that, If no hearing Is granted to any authority delegated to the Commissioner T4K., R. 68 K.. other party regarding the matter, the (21 CFR 2.120): It <s ordered, That the See. 0: lot 1. FEDERAL REGISTER, VOL. 37, NO. 155--THURSDAY, AUGUST 10, 1972 GLD007112 PROPOSED RULE MAKING 25819 , (a) Amounts deposited pursuant to producers pursuant to the declared pol 191.9 Banned ba/.ardotn mbMsnr r*. subdivisions (1), (U>, and (111) ol this subparagraph (Including buy voluntary deposits made pursuant to paragraph <b) (3) of tills section!, and (b) Amounts paid pursuant to para graph (a) U) of 9 1.14(51-3, lor such cal endar year, icy of the act. The proposal is as follows: Order. In ! 005.645 (Orange Regulation 71: 37 F.It. 21799, 24432, 35036) the pro visions of paragraph (a) preceding sub paragraph (1) thereof are amended to read as follows: (ft) * * (6) (1) * * * (c) The provisions of this subdivision (i) do not apply to: (f) Automotive. ngricuHum.1. nnd In dustrial equipment refinish coatings; (2) Industrial (and commercial build the withholding agent shall deposit the balance or tax due tor such year with ft Federal Itcserve bank or authorized commercial bank on or before the 15th (lay ot the third month following the close of the calendar yenr. (v) Transitional rules. Notwithstand ing the provisions of paragraph (a)(1) of 11.1461-3 and of subdivisions (1) and (11) of this subparagraph, the aggregate amount of tax required to be wltliheld under chapter 3 of the Code by any withholding agent after December 31, 1960, and before Jiuio 1, 1907. shall bo deposited with a Federal Reserve bank on or before June 22,19G7. For tbo pur pose of paragraph (b) (2) or this section any amount deposited In accordance with the requirement of this subpara graph shall be considered as If It were deposited with respect to amounts with held during the calendar quarter begin ning April 1.1907. (3) Cross reference. For rules relat ing to the adjustment of deposits, see 11.1461~4(b) and 1 1.6414-1. For rules requiring payment of any undeposiled tax, see 11.1461-3, (FR Doc.73-aoei3 Piled 12-4-72,* :83 am] 905.513 Orange Ilcguliilion 71. (a) During the period January 1,1973, through September 30, 1973, no handler rholl ship between the production area nnd any point outside thereof In the con tinental United States, Canada, or Mexico. All persons who desire to submit writ ten data, views, or arguments In connec tion with the aioresntd proposal shall file the same. In quadruplicate, with the Hearing Clerk, U.S. Department of Agri culture, Room 112, Administration Build ing, Waslrlngton, D.C. 20250, not later than the lOih day after publication of the notice In the Fed er al Rec is t er . AU written submissions made pursuant to thin notice will be made available for public Inspection at the office of the Heaving Clerk during regular business hours a CFR 1.27(b)). Dated: November 30, 1972. Pa u l A. Nic h o l s o n , Deputy Director, Fruit and Veg etable Division, Agricultural Marketing Service. |FR Doc.72-30826 Piled 12-4-72;*:4 am] ing) maintenance coatings, including traffic and safety marking coatings; (3) Graphic art coatings (products marketed solely for application on bill boards. road signs, and similar uses and for Identification marking in Industrial buildings); (<) Touclmp routines for automobiles, agricultural anrl industrial equipment, lawn and garden equipment, boats, out board motors, motorized recreational ve hicles, and appliances; (5) Exterior marine coatings for small craft application; (5) Exterior rubber-based roof coat ings: and (7) Exterior primer coatings for wood 6ldlng containing extractives (products . marketed solely for application on red wood nnd cedar); Provided. That these products bear on the main panel of their label. In oddition to any labeling that may be required under the act or regulations promulgated pursuant thereto, the signal word "WARNINQ" nnd the following state ment: "CONTAINS LEAD. DRIED FILM ON THIS PAINT MAY BE HARMFUL IF EATEN OR CHEWED. Bee other cau tions on (side or back) panel." These products shall also bear on their label DEPARTMENT OF AGRICULTURE DEPARTMENT OF HEALTH, the following additional statement or Its practical equivalent: Agricultural Marketing Service EDUCATION, AND WELFARE Do not apply on toys and othor children's articles, furniture, or Interior surfaces of any r 7 CFR Part 905 ) Eood and Drug Administration dwelling or facility which may be occupied or \ised by children. ORANGES, GRAPEFRUIT, TANGER INES, AND TANGELOS GROWN IN FLORIDA I 21 CFR Pari 191 1 BANNED HAZARDOUS SUBSTANCES Do not opj>ly on thooe exterior surfaces ot dwelling units, such as window sills, porches, etalr?. or railing*, to which children may be commonly exposed. Proposed Handling Limitations Proposed Exemption of Certain Lead- Keep out of reach of children. Consideration la being given to tile Following proposal submitted by the com mittees, established under the marketing agreement, as amended, and Order No. 905, as amended (7 CFR Part 905), regu lating the handling of oranges, grape fruit, tangerines, and tungelos grown In Florida, effective under the applicable provisions of the Agricultural Market ing Agreement Act of 1937, tw amended <7 UJ5.C. 601-674). The proposal would extend current grade and size limita tions, for the period January 1, 1973, through September 30, 1973, applicable to oranges. Including Navel, Temple, and Murcolt Honey oranges (but not includ ing Valencia, Luc Gim Gong, and similar late maturing oranges of the Valencia type), handled between the production area and onv point outside thereof In the continental United States, Canada, or Mexico. The proposed extension of the period of regulation of certain varieties of oranges Is designed to continue In effect the current quality and sire requirements for such fruit* consistent with (1) the available supply and the demand for such fruits; and (3) improving returns to Containing Paints and Other Simi lar Surface-Coating Materials Hie Commissioner of Food and Drugs has received ft petition from the National Faint nnd Coating Association, 1501) Rhode Island Avenue NW., Washington, 1X1 20005, submitted pursuant to section 701(e) (1) (B) of the Federal Food, Ding, and Cosmetic Act, proposing an amend ment to a regulation (21 CFR 191.9(a) (6) (1)) promulgated under section 2(q> (1) (13) of the Federal Hazardous Sub stances Act. Tire proposed amendment would exempt certain lead-containing coatings from classification as banned hazardous substances. The petition states that the submission Is on behalf of its members which manu facture and market certain specialty paints in which lead Is a necessary com ponent. Section 191.0(a)(6) was promulgated In the Fed er al * Reg is t er of March 11, 1973 (37 F.R. 5229), nnd its effective dote wns confirmed In part hr the Fed er al Rf c i.me r of August 10, 1972 (37 F.R. 1C078), 17ie proposed amendment prepared by the petitioner reads as follows: The placement, conspicuousness, and contrast of the above labeling shall be in accordance with the requirements of l 191.101. ** The following Is the statement of grounds given In the petition In support of the proposed amendment: On March 11, 1972, the Food and Drug Administration published an order in the Fe d er a l Re g is t e r <37 FJR. 5229) under section 2(q)(l)(B) of the Federal Haz ardous Substances Act which, in part, declared any paints or other similar sur face-coating materials Intended, or pack aged In a form suitable for use In or around the household, to be banned haz ardous substances if: (1) Shipped in in terstate commerce between December 31, 1972, and December 31, 1973, and (2) containing lead compounds of which the. lead content Is In excess ol 0.5 percent of the total welghtof the contained solids or dried paint film. On August 10,1973, this portion of the order was confirmed a* effective; that portion of the order per taining to a 0.06 percent lead level re mained under consideration by the Agency. No. 234--Pt. i--c FEDERAL BFCISTEV, VOl. 37, NO. 334--TUESDAY, DECEMBER 5, 1973 GLD00 7113 N 2260.06 . . >, - ^ V .* , 25850 PROPOSED RULE MAKING 'JS'BSD The Federal Hazardous Substances Act household eurfaccs, usually by profes mlltco Report on the Lead-Based Paint applies to paint products which arc found sional painters, and they are not In Poisoning Prevention Act Amendments , to be toxic, which arc intended or pack tended or suitable for use on surfaces of 1072 refers specifically to coatings aged In it form suitable for use In or accessible to children which would cre "Intended for Interior residential sur around a household, and which may ate a hazard. The Morch 11 regulation faces" (S. Rep. No. 02-852, 93d Cong., causo substantial personal Injury or Ill appears to cover these specialized pnlnts 2dScss. (1072)). ness as a result of "reasonably foresee solely because they inay at times be Similarly, under tho Lead-Bared Paint able Ingestion by children" (15 U.S.C. found In or around the household in Poisoning Prevention Act (Public Law 1261(f)(1)(A)). Most paints In llcpild packaged form and not because of any 01-895) the Secretary of Housing and form are not considered toxic under this finding that they pose a lead hazard to Urban Development, in consultation act because the viscosity of the paint children. with the Secretary of Health, Education, product renders the Ingestion hazard ex Congress, In enacting the Federal Haz and Welfare, was Instructed to develop tremely remote. Only after the paint ardous Substances Act, contemplated the and carry out a demonstration and re product has been applied to a surface dangers offered by a product or article In search program "to determine tho nature accessible to children, and then usually Its liquid state and In its packaged form and extent of the problem ot lead-based only after the film has finked or chipped, ami thus designed the act to regulate paint poisoning In the United Plates, docs a hazard arise tlmt children may in all products "Intended or packaged In a particularly in urban mean, mid the ; gest the lead content. form suitable for use In or around the methods by which lead-based paint can ! Thus, this petition la not nccessnry household." Implicit In the quoted lan most effectively be removed from interior j because of the requirements of the act guage fs the assumption that the par surfaces, porches, and exterior surfaces i since the specialty paints, which are ticular hazard from a product Is posed to which children may be commonly cx- ! the subject of this petition, arc neither simply because that product Is present posed, of residential housing." I Intended nor likely to be used on sur in the household In packaged form. Acting under this authority, the Src- faces which are reasonably available to While this Is true of a substance which retary of HUD 1ms determined that the | children or on surfaces which will en presents a hazard In Its liquid state as. existing conditions that pose a lead paint ' able flaking and chipping of the paint. for example, the flammability hazard of hazard to children aro those surfaces This petition is required only because c ertain liquid paints, this Ls not true of reasonably available to children that j the language of 5 101.0(a) (6) (1) appears the load Ingestion hazard from paints. present peeling or flaking paint. This 1ms ! to be broader In scope than the language The particular hazard posed by lead con been recently confirmed by the rgency by In the statute and broader In s c o ih j than tent In paint does not occur from the a publication In the October 21, 1972, Is necessary to protect against the lead liquid paint In the package but, Instead, Issue of the Fe mr a i Rt o s ir r (at pngo hazard from the dried paint film. The the hazard occurs solely from the dried 22732) entitled "Prohibition of Use of pertinent portion of the regulation reads paint film If Ingested by children. Lead-Based Paint and Elimination of as follows: "Any paint or other similar surface-coating material Intended, or packaged in n form suitable, for use In or around the household". If this opera tive language had been limited to The best Information available Indi cates that children who are disposed to chew paint chips confine their activity primarily to interior eurfaccs In tho house and, perhaps, infrequently to an Lead-Based Paint Hazard." This revises pertinent parts of the Code of Federal Regulations already promulgated under authority of the Lead-Based Pulnt Polsonlng Prevention Act. in this revision, | , surface-coating materials which after accessible exterior surface. Children with respect to the use of and elimination application would pose a lead hazard usually are attracted by flakes from old, of existing hazards caused by lead-based because of reasonably foreseeable Inges chipped paint film rather than ncwly- paint, the Secretary of HDD defines "ap tion by children. It Is clear that the reg coatcd surfaces, and by toys or other plicable surfaces" as all Interior surfaces ulation would not apply to these specially articles which they may place In their and those exterior surfaces, such ns products. This petition for an amend mouths. This Is duo in largo part to tho stairs, decks, porches, railings, windows, ment is submitted, therefore, only to limited physical abilities of tho young and doors, which are readily accessible to clarify the scope of | 191.9(a) (6) (i) of children suffering from "pica," tho habit children under 7 years of ngc." Fmthor, the regulations. of ingesting nonfood items. "Health Hazard," with respect to lend- The Definitions and Procedural and Interpretative Regulations, under FHSA <21 CPU Port 191.1), specily that the net As i>o)nted out in comments to tho subject regulation, submitted by Dr. Harry King and Dr. JullRn Chisholm based paint, Is defined to mean "crack ling (sic), scaling, pooling, and loose lcad. based paint on applicable surfaces." covers those products that under custom (noled authorities on lead poison big), Since the prohibition against use of ary or reasonably foreseeable conditions tho most critical age for exposure oi a lead-based paint under this revision ex of storage or usb may be brought Into or child through ingestion of paint, putty, tends only to use on "applicable surfaces around a house, apartment, or other and other load-contatrdng nonfood ma of any residential structure." clearly then plare people dwell. Including a garage, terials Is usually 1 to 3 years of ngc. In these are the only surfaces found by this carport, bam, or storage shed. The same view oi both the restricted mobility and agency to pose a lead hazard to children. regulations expressly state that the act physical limitations of children in this There is no Indication by IIUD that tho docs not cover Industrial supplies that age bracket, they neither ltave acccsw to, surfaces to which the products under might be taken into a homo by a service nor are capable of chewing or Ingesting, consideration are applied present either man. The Interpretations specifically pro paint chips from surface to which tire an existing or futuro lead poisoning vide that a product labeled as and mar products for which exemptions arc herein hazard to clilldren. keted solely for Industrial use docs not roquestod are applied. In fact, we are not It Is clear from tho foregoing that the become subject to the act simply be aware of nny documented case where a hazard sought to bo prevented by lead cause an Industrial worker could possi child lias attempted to Ingest the paint tolerances established In 5 191.9(a)(6) bly misappropriate a supply for his own film on automobiles, farm and garden Is lead Ingestion by child: cn who tend to use. Implements, etc. chew dried pnint film on Interior and Thus, this Interpretative regulation The American Academy of Pediatrics, exterior household surfaces accessible to leaves no doubt that industrial coalings, In Its November 30, 1071 memorandum these children, and on toys or other arti such ns original finish coatings for auto to the Food and Drug Administration, cles Intended for use by these children. mobiles, Industrial equipment, and farm appears to confirm this: "The American The regulation is not Intended to nor and garden equipment are outside the Academy of Pediatrics endorses the prin should it reasonably apply to the special scope of the act and therefore remain ciple contained In the petition filed with ized paints under consideration since, unaffected by the proposed tolerances. tlio Commissioner that paints contain through customary or reasonably fore The specialized coating products which ing more than minute tfaces of lead he seeable conditions of use, tbey will not are the subject of this petition are simi declared as banned hazardous sub causa a lead hazard for pica children, lar to the industrial or factory-applied stances, ff Intended for use on children's even though they are packaged in ft form coatings tn many respects. They are In products or Interior surfaces (emphasis suitable for use in or around the house tended primar ily for application to non supplied)." Further, the Senate Com- hold, and thus. Incidentally may meet FEDERAL REGISTER, VOL 37, NO. Z34--TUESDAY, DECEMBER 5, 1972 GL0007114 PROPOSED RULE MAKING 25851 the definitional test of J 191.1(c), This re finishing may occur in or about sold for maintenance of plant nnd equip namely, that "under any reasonably n garage, barn, or shed. ment, commercial buildings, structural foreseeable condition of purchase, stor- These coatings are usually high-gloss steel (such as bridges), or for safely ni;e, or use the article may be found In and me customarily applied by sprny markings or pavement markings In or around a dwelling." Thus, petitioners equipment. Lead is an essential ingredi streets or parking lots. I*ad pigment, believe these products should not be sub ent in many of these coatings for three such ns In the commonly used red -lead ject lo the provisions of the regulation. reasons. First, it is a catalytic drier, primer, in an important ingredient In Unlike Interior household paints or necessary to speed the oxidation process these coatings, principally because It re even exterior paints for household ap and, thereby, prevent dirt or dust from sists corrosion. I.end pigments also plication which could conceivably be becoming embedded in tho film. Second, achieve the brilliant opaque etui durable substituted for Interior use or applied load-containing pigments are necessary colors required for safety markings on on an exterior surface accessible to chil to match original equipment colors and pavements and Industrial areas. There dren, these specialized products nvc never to prevent a displeasing patchwork ef arc no substitutes for the lead colors flr<t marketed for such application. They are fect in coloring .which otherwise would will adequately perform the same pur neither Intended, designed, nor suitable appear after a short time due to color poses. Organlo compounds are weaker In for use In areas accessible to children. chalking and fading. Finally, lead pro tinting strength, me less durable to Those products are limited in purpose vides flic essential resistance to weather weathering, and have a tendency to bleed and, since they arc not general household ing, heat, and other environmental con when ovorpaliitcd. products, are thus purchased infre ditions to which automobiles, agricul Those products are intended for uses quently and never stored around the tural and industrial equipment are which pose no health hazard of chil household in any significant quantity. peculiarly exposed. dren. Industrial plants, commercial oflke Furthermore, most of there products are When used for the intended purpose, buildings, metal equipment, structural Intended for the professional consumer. there exists no health hazard to childien. steel, bridges, and the like ere not acces The precautionary label proposed 111 Indeed, the only difference between the sible to children. Additionally, the Con this petition adds nn extra measure of original factory-applied finish {which is gress. after hearings, has recognized tliftt protection against any conceivable risk not regulated by the act unless applied such uses arc not hazardous. In enacting from its lead content due to misuse. The to any toy or other articles Intended for the Lcnd-Jlnst'd Paint Poisoning Preven possibility of misusing these products, use by cliildren) and the rcllnlsh product tion Act of 1971 (Public Law 91-699), oven without the precautionary label is, is that a can of the latter may find Us Congress eliminated the language "any however, very remote. The garish color way into or near the home. The hazard building or structure," ami substituted and rough texture of an industrial main exists, however, not from the liquid in "interior sui faces, porches, arid exterior tenance coating, such as a red-lead the container but only from tho dried surfaces to which children may be com- primer in which lead Is an important film and then only K the film can be monaly exposed" in order to exclude in protection material, makes it exceedingly ingested by children. It is not reasonably dustrial and commercial building main unlikely that anyone would use it on foreseeable that a child would chew on tenance use (S. Rep. No. 91-1432, 91st interior household surfaces or other sur the paint because of the hard substrate Cong., second session 4-5(1970)1. faces accessible to children. Other spe to which the pain t is applied. Again it Is not reasonably foreseeable cialty products, such as automobile Because of the nature of these rc- that industrial maintenance coatings reflnlshcs. are generally too expensive to flnishing products and their labeling, it would be misused and applied to a house be feasible for use on such surfaces. is not reasonably foreseeable that they hold surface accessiblo to children. Largo Others, such as toucliup coatings in would be used for other than their in volume users purchase these products aerosol containers, arc packaged in tended purpose. There are many reasons directly from manufacturers, nnd these quantities too small for practical use on for tills: products are generally unavailable for household surfaces. Additional signifi a. Spray application, usually with use around the household. Some retail cant factors militating against misuse of liigli-prossiirc sprayers, is rccoinmeudcd outlets may stock and sell certain lines these products are explained in tho fol for all of these products, and satisfactory of these coatings in limited volume to lowing discussions of the individual results arc not obtained with a brush or smaller industrial accounts. Such indus products along with an explanation of roller; trial maintenance coatings normally are wily lead is a necessary component in b. The high gloss colors found in most labeled "Intended for professional use these coatings. of these coatings are not suitable for only and not for retail sale." In addition, Dis c u s s io n or Sp e c ia l Puarosr Co a t in g s 1. Automotive, agricultural, and indus trial equipment reflnish coalings. Auto motive, agricultural, and industrial surfaces In the home; c. At the retail level, automotive re- flnishes are roughly twice as expensive rs household enamels nnd paints, and thus it is exceedingly unlikely that con they will bear the lead warning label required by the proposed amendment. Thus, the possibility of household use Is virtually eliminated. 3. Graphic art coatings (products equipment reflnish coatings are designed for use by automobile repair shops or agricultural or industrial equipment dealers for the reflnish of automobiles, trucks, agricultural, and Industrial ma chinery. These reflnish coatings arc marketed through automotive warehouse distributor* to automotive parts Jobbers, and then to automotive body shops. Agricultural and industrial equipment coatings are sold by equipment man ufacturers and subsidiaries to equipment dealers. sumers would purchase automotive re finish coatings for use on either an in terior or exterior household surface since cheaper, better-suited products are more readily available. Further, such costs pre clude purchasing more than Is actually needed to reflnish an nutomobilc; d. These reflnishes, in contrast to gen eral purpose household enamels and paints, often require careful preparation of the metal surface, including grinding, etching, and priming in order to obtnln proper adhesion; nnd marketed solely for application on bill boards, road signs, and similar uses, and for identification marking of industrial buildings). These paints or coatings, ap plied freehand or by hand using ft stencil or similar technique, are used to present a graphic image or convey a message. On the basis of Intended use and because ol a-general lack of access by household consumers and children to cither the coating or coated surface, graphic nits coatings should be excluded from the regulation. Although these reflnish coatings arc e. The proposed warning label would While these coatings may be stocked intended for use by automotive body provide additional protection by indicat by some dealers, they are intended prin shops or farm and industrial equipment ing to the purchaser that such coatings cipally for use by professional sign paint dealers and are not marketed primarily should not be applied on auy surface ers for tile application or colors to bill for retail customers, some of these com accessible to cliildren. boards, billboard structures, load signs, panies have a secondary retail trade, 2. Industrial (and commercial build and similar items and for Identification Such retail customers use these coatings ing) maintenance coatings, including markings ol Industrial buildings and the to reflnish automobiles, agricultural traffic and safety markings coalings. This equipment Installed therein. Most of equipment, and Industrial machinery. category Includes a variety of coatings these coatings are used only under FEDERAL REGIS1ER, VOl. 37, NO. 534--TUESDAY, DECEMBER 5, 1975 GL0007H5 '25852 -V PROPOSED ROLE MAKING Jfffi / s specific shop conditions for application that such coalings would be misused for human experience, which Indicate that to plastic and metal .surfaces, such as other purposes In or around a household children have Ingested dried paint films Illuminated signa advertising particular because other, hotter suited, loss costly from the types of surfaces on which Ibe businesses (e.g,, service stations), or lor coatings are more readily available. products described herein are applied, road-directional markers. Finally, the proposed warning label would nor is It reasonably foreseeable that such The need for such contrasting colors clearly indicate to the consumer t hat the Ingestion would occur. Additionally, con Is mandatory for these types of Identi coaling should not be applied on any sidering the Inaccessibility ot the sur fication. Existing technology provides no areas accessible to children. faces to wlilch these print films are ap substitute materials for lead which will 6. Exterior rubber-based roof coat plied and/or the hnrdnrss of the film or provide the brilliance, color permanence, ing These coatings are unique in that substrate to which they are npj lied, In- and film durability necessary for ex they are nibbor-bnsed as opposed to gestion of these products after applica tended periods of service, particularly the types of materials used In other coat tion Ls not reasonably foreseeable. Fi under the temperature, sunlight, ond hu ings. Lend oxides are the only known nally, and as previously pointed out, tho midity conditions of outdoor exposure. materials available for curing the liquid likelihood of misuse of there pioducts is Furthermore, for ninny of Iheso uses, coatings when applied to surfaces such exceedingly remote. such as application to road signs, these ns roofs where waterproofing Is essential. Accordingly, this petition Is submitted coatings are baked on. No acceptable Oxides of no oilier metals exert any Influ In the Interest of establishing, foi both Etonlead colorants, wlilch can withstand ence on the cure of these rubberized coat the consumer mid the Industry, clarity such baking, are presently available. ings. In addition, lead oxides aro required and certainty with respect to the scope of 4. Touchup coatings for automobiles, agricultural and industrial equipment, town and oarden equipment, boats, out board motors, motorized recreational vehicles, and appliances. These coatings are packaged to small containers or In for improved water resistance. These sur faces ara obviously not accessible to children and, thus, tho Intended or rea sonably foreseeable use will not create a health hazard for children. 7. Exterior toood primer coalings for the subject regulation. 'Phis would ulao avoid the possibility of unwarranted regulatory action resulting from a lrck of such clarity and certainty and provide a sound enforcement basis for labeling these classes of products. t aerosol containers for use by the con mood siding containing extractives sumer la making minor surface repairs (product* marketed solely for use on redto bis automobile, household appliance, toood or cedar). Lumber used for fabrica PRoeenunx Since tills petition Is filed prior to the or other mechanical equipment which tion of siding materials may at times bo Implementation dato (Oeceml'cr 31, may be found In the vicinity of Ills homo. cedar or redwood, each of which contains 1972) of the lead order, It is requested While Intended primarily for use in mid water-soluble materials which can be tliat tho publication of this potation have around the household, they are neither leached by moisture and deposited at or tho effect of suspending the effective Intended nor suitable for application to near the paint surface. These staining date of tho order, pending review ot large surface areas accessible to chil chemicals can have Increased solubility comments and promulgation of a final dren. 'Ihe hard metal surface of the ve In the lilgli pH of emulsion paints and order In this matter, only os It applies hicles, appliances, or other equipment on can accentuate the development of un- to those paints and similar surfnco which these coatings are applied do not sllghtly stains on the paint film. A lend coating materials which petitioners sub lend themselves to chewing by children. compound primer Is used when the bare mit should not be subject to tho order. The very ttiln, hard coating film on such substrate Is cedar or redwood, in order Without such a suspension, the nitmulac- surfaces cannot bo removed and In to Insolublllze the stains before they turo and distribution of the products gested by chewing. reach the topcoat. Continued manufac would be totally disrupted. Mnnufec- These coatings are packaged and mar keted in small quantities, discouraging their use on anything except nn extreme ly small area. As with automotive reflnLsii coatings, they generally aro not suited for use other than as Intended. Further more, to Insure against any misuse of this product, each container will carry the required labeling, warning of the lead content and restricting the use of the product. 5. Exterior marine confines for small craft application. Thn bulk of marine coatings aro marketed for Industrial uso only, are sold In containers not suitable for use In and around the housclwld, and, therefore, aro outside the coverage of tho act. Yet, marine coatings also are sold in significant volume at retail for use by consumers In coating small craft, and these coatings could be found in or around the household. Lead Is an essential Ingredient for these coatings, primarily for the same reasons It is needed In Industrial mainte nance. Lead is a necessary component for corrosion control; there are no satisfac tory substitutes. As with automotive refinish coatings, lead Is needed in marine coatings to provide resistance to weath ering and other environmental condi tions. When used for their intended pur pose, marine coatings do not pose a lead hazard to children since the coated sur ture and sale of exterior staining wood prlmera of this type, which contains lead. Is necessary for tills limited purpose. We do not believe that the use or this product poses a reasonably foreseeable load hazard to children for each of the following reasons: n. A lead-conlalnlng primer need only be used once, and thus, there Is no build up of layers of lead-containing paint, which is recognized as a primary cause of lead poisoning; b. Exterior house siding Is not readily accessible to children in the sense that porch rollings and ornamental surfaces are accessible; o. Staining, as distinguished from nonstaining, woods are not widely used for siding; and d. Some of the primer penetrates the wood substrate and thus, should the coating peel, little, if any, of tho primer peels with It. Su mma r y Wlille a number of these special pur pose coatings may be found In or near the household in packaged loan, no lead hazard to children arises either before or after they ore applied to the surfaces for wlilch they are intended. Only "household" paints that aro Intended to bo applied to surfaces accessible to chil dren can pose the lead hazard sought to bo prevented by the regulation In question. turera have not known and still do not know whether to continue or discontinue tho marketing of these specialized coat ings sinco there Is a substantial unre solved question of their status under tho lead order. Additionally, until this ques tion Is finally resolved by a final order, customers of these mnmilnclureiG, such as distributors or users having a second ary retail trade, cannot with confidence contlnuo to purchase such products. This Is because It may be necessary for them to Introduce the products Into Interstate conunerco subsequent to the Decem ber 3t, 1972, Implementation date. This petition Is not Intended to affect the Implementation date of tho lend stand ards as they apply to other paints and surface-coating materials. An additional factor for consideration relates to tho labeling required by tho proposed amendment. Until tho Commis sioner determines by regulation the ac ceptable or desirable label statements for the spcclnl-puvpose coatings under con sideration, manufacturers cannot with confidence label or relabel now produc tion. It will be necessary, therefore, to consider lend time for nn Implementa tion date for such labeling as mns' bo required. Blnce this petition was received prior to tho Implementation date (Decem ber 31. 1972) of f 191.0(a)(6) (l)(b>, the publication of tills proposed amendment faces are not accessible to them. Fur We arc not nware of any data. Includ shall have the effect of suspending said thermore, It la not reasonably foreseeable ing reports In medical literature or implementation date, only as It applies FEDERAL REGISTER, VOL. 37, NO. 234--TUESDAY, DECEMBER j, 1972 GLD007116 PROPOSED RULE MAKING 25853 to those points and similar surface- dures, however, would involve delay In the quarter for each of the public, assist coating materials as described in tills Implementing urgently needed measures, ance programs under tho Act. From these proposal, pending review of dpmmcnts found to bo necessary for the proper and estimates the State and Federal sharrs and promulgation of an order hi this efficient administration of the assistance of the total expenditures are computed. matter, 'nils proposal will In no way programs, which are to become effective The State's computed share of total esti alfcct tlio Implementation date of { 191.- January 1, 1973. Such delay would be mated expenditures Is the amount of 9(a) (0) (1) (&) ns it applies to other paint contrary to the public Interest. Accord State and local funds necessary for the and similar surface-coating materials. ingly. we find that there Is good cause to quarter. The Federal share Is the basis Tills proposal Is being Issued pursuant reduce the usual period of notice. Com for the funds to be advanced for the to provisions of the Federal Hazardous ments received will bo available for pub quarter. The State agency must also cer Substances Act (sec. 2(q) (1) (B), (2), 14 lic Inspection in room 6121 of the Depart tify, on this form or otherwise, the Stat. 372, as amended by 80 Stat. 1304; 10 ment's offices at 301 C Street SW., Wash amount of State funds (exclusive of any U.3.C. 1201 (q) (1) (B), (2>) and tlie Fed ington. D.C., on Monday through Friday balance of advances received froth the eral Food, Drug, and Cosmetic Act (sec. of each week from 8:30 a.m. to 6 p.m. Federnl Government) actually on hand 101(e), 62 Stat. 1055, as amended; (21 (urea code 202--9G3-73G1). and available for expenditure: this cer U.S.C. 371(e)) and under authority The proposed regulations are to be is tification must be signed by the execu delegated to the Commissioner of Food sued imder section 1102, 49 Btat. 647, tive officer of the State agency submitting and Drugs (21 CFH 2.120). Interested 42 U.6.C. 1302. the estimate or a jierson officially desig persons may, within GO days after pub lication hereof In the Fed er al Reg is t er , Dated: November 29,1972. nated by lilin, or by a fiscal officer of the State If required by State law or regula fllo with the Hearing Clerk, Department Jo h n D. Tw in a me , tion. (A form ''Certificate of Availability of Health, Education, and Welfare, Room Administrator, Socicit of State Funds for Assistance and Ad 6-88, 6600 Ftahere Banc, Rockville, Ml) and Rehabilitation Service. ministration during Quarter" Is available 20853, written comments (preferably In quintuplicate) regarding this proposal. Ainnovcd: November 29,1972. for submitting this Information, but its use is optional.) If the amount of State Comments may be accompanied by a memorandum or brief In support thereof. El l io t L. Ric h a r d s o n , Secretary, funds (or State and local funds if local ities participate In the program), shown 'Received comments may be seen In the above office during working hours, Mon day through Friday. Dated: November 29. 1912. 8a m D, Fin e , 1. Section 201.5 of Fart 201, of Chapter II, Title 45 of the Cotie of Federal Regu lations is revised to read as set forth below; 201,5 Grants. as available for expenditures Is not suf ficient to cover the State's proportionate share of the amount estimated to be expended, the certification must contain a statement showing the Eouree from which the amount of the deficiency Is Associate Commissioner for Compliance. jrn Doc.72-30789 Filed 12-4-72;8:45 m] To States with approved plpns, Rrnnts expected to be derived and the time when are made, prior to the commencement of this amount Is expected to be made each quarter, for estimated expenditures available. under the plan for assistance, serv (3) The State agency must also sub ices, training, and administration. The mit a quarterly statement of expenditures Social and Rehabilitation Service amount of the quarterly grant award Is for each of the publlo assistance pro 145 CFR Parts 201, 2061 based upon estimates submitted by grams under the Act. This Is an account the State, containing Information re ing statement of the disposition of the PUBLIC ASSISTANCE PROGRAMS quired b.v the Administrator, and such Federal funds granted for past periods other information available to the and provides the basis for making the Payments for Ineligible Cases and Department as may be necessary to esti adjustments necessary when the estimate Overpayments for Eligible Cases; mate expenditures properly subject to for any State for any prior quarter was Exclusion of Expenditures Notice Is hereby given that the regula tions set forth in tentative form below are proposed by the Administrator, Social and Rehabilitation Service, with the approval of the Secretary of Health Education, and Welfare. Tlie proposed regulations lelntc to the programs of financial and medical assistance, author ized under title I, IV-A. X. XIV, XVI, and XIX of the Social Security Act. Federal financial participation. (a) Form and manner of submittal. (1) lime and place: The estimates for public assistance grants for each quar terly period must be forwnided to the Department of Health. Education, and Welfare, Social and Rehabilitation (Serv ice, Washington, D.C. 20201, Attention: Office of Financial Management, with copy to the regional office 45 days prior to the period of the estimate. '17icy In clude a cert ificat ion of State funds avail greater or less than the amount the State actually expended In that quarter, live statement of expenditures also shows the share of the Federal Government In any recoupment, from whatever source, of expenditures claimed In any prior pe riod, and also In expenditures not prop erly subjeot to Federal financial partici pation which are acknowledged by the State agency or have been revealed in the course of an audit. (4) Effective for quarters beginning The proposed regulations would ex clude from Federal financial participa tion. all expenditures for payments for Ineligible cases and overpayments for eligible cases. able and o justification statement in support of the estimates. A statement of quarterly expenditures end any neces sary supporting schedules must bo for warded to the same addresses not later with the quarter commencing January 1, 1973, all expenditures lor payments of financial and medical assistance for in eligible Individuals or families and over payments for eligible cases shall be Prior to the adoption of the proposed than 30 days after the end of tho excluded from State estimates and regulations, consideration will be given quarter. An annual supplement to the expenditure reports. to any comments, suggestions, or objec tions thereto which are submitted In wilting to the Administrator, Social and Rehabilitation Service, Deportment of Health, Education, and Welfare, 330 In dependence Avenue SW., Washington, DC 20201 within a period of 20 days from the date of publication of this notice In statement or expenditures, for account ing for social service expenditures In accordance with the limitations of section 1130 of the Social Security Act, must also be forwarded to the same addressees not later than CO days after the end of the Federal fiscal year, (2) Dose rl pi Ion. of forms; "State (b) Review. The State'6 estimates are analyzed by the regional office staff and are forwarded with recommendations as required to the central office. In comput ing the grant, the central office reviews the State's estimate, other relevant in formation, and any adjustments to be made for prior periods. Relevant infor tho Fed er al Reg is t er . It Is the policy of Agency Expenditure Projection--Quar mation as to payments for Ineligible in the Department that 30 days' notice will terly IToJectlon by Program" represents dividuals or fntnllles and overpayments be given for proposed rule making la the State agency's estimateof the total includes the most recent data available the formulation of rules and regulations amount and the Federal share of expend from reports (ns required under | 205.40 governing the Department's grant pro itures for assistance, cervices, training, of this chapter) on quality control re grams. Compliance with such proce and administration to be made during views of State samples or the national FEDERAL REGISTER, VOL. 37, NO. 234--TUESDAY, DECEM8ER 8, 17)2 j GLD007117 PROPOSED RULE MAKING m 8 51.K0 Operation! and operating pro cedures. DEPARTMENT OF HEALTH, 52291, classifying cevlsln lrad-contplnlug paints nnd other rbnilnr sm face-con'log * ** (0) * (0) Submit, to the Chid of tho Fresh Products Standardization nnd In*=peo- Uou Brcouh, Fruit and Vegetable Divi sion, Agricultural Marketing Her vice, for approval prior to printing, draftings or printers' proofs of rmli packer's or distributor's label healing or refetring in luiy manner to official.Inspection legends or grade marks. # (Sera. 201, 20(1, GO FUnt.. 10H7. ivs amended, 1090 SR nmcmlrtl; 7 11 B O. 1002. 11524) Dated: December 20,1072, E. I.. Pet f u s o n , EDUCATION, AMD WELFARE Food and Drop Administration l 21 CFR Pari 3 1 VITAMIN A AND VITAMIN D Proposed Statement of Policy; Correction The Commissioner of rood nnd Drugs Trued a proposed statement of policy an lire me of vitamin A nnd vitamin D which v.ns published In the FrnF.RAi. Hrera mi. of Thursday, December 14, 1972 (37 bit materials ns banned hav,ardour sub stances. Tills regulation <21 Cl it 191.9 (a)(0)) wus promulgated under section 2(q) U'()l) of the Federal Hrv/arduvs Substances Act. Section 191.0(a) (0) (1) (lclmcj ns a banned hazardous .'nibstanco rnv p;>mt or other similar Rurinoe r eiki'' >c teiial intended, or packaged in a In a suitable, for use hi or an.-nnd a Imv hold that Is shipped In int u.' lrlo com mcrco between December 31. 1077, nod December 31, 1073, nnd that eonl-vo-. lend compounds of which thi lead ecu. tent (enlculnted as the mrlnl) Is in rv res* of 0.5 percent' of the Intel weigh' >f the contained solid: ot diiid paint P'm Adiiilni.-.tiator. 20010). 'Die provisions of the piojiorcd The effective date of Ill's re it of th" p - Agricultural Marketing Service. pew sections should be corrected ns ulatton was confirmed In the It mo i, |FR Doc.73 07 Filed i-3 73;0:45 runJ Commodity Credit Corporcdion f 7 CFR Perl 1430 1 follows: 1. T he proposed 5 3.---- Vitamin A preparations for oral use nj drugs In amended by deleting paragraph (b)(3), redesignating paragraph (c) ns para Heo imt er of August 10, 1972 (37 FH. 100710. Blncc the pioniulf.ntion of sitd hen- ntnq regulation, the Food and Dior, Ad ministration 1ms received ninny Inquiries and adverse responses concerning I ho PRICE SUPPORT PROGRAM TOR MILK graph <d), nnd adding a new paragraph buimtng of artists' paints due to their Loans, Purchases, cind Other Operations Notice Is hereby given Hint the Secre tary of Agriculture, under authority of (c) to read os set. forth below. fi 3.------- Vitamin A preparations for oral use ns ilnigs. ** lead content. These deal sped(1 sally will* lend enrbonato (also known us whitlend, flake white, crenmttz white, mid silver white). Interested pinions slide (1) that lead Is a necessary component section 201(c) of the Agricultural Act of <)>) * of artists' paints, (2) that n satisfactory 1949, as amended <03 Btnt. 1051. as amended: 7 U.S.C. 14461, and sections 4 and 5 of the Commodity Credit Corpora tion Charter Act. ns amended <02 Stat. 1070, as amended; 1& U.S.C. 714b and Vl4c), Is considering the terms and con (3) I Deleted 1 (c) Preparations containing 10,000 or less 1.47. of vitamin A per dosage unit will be regarded os misbranded If their rec ommended dally dosage exceed* 10,000 substitute for lead Is not cunently avail able, and (3) tliat although these prod ucts are both Intended nnd pa dinged in n form suitable for use in mul avmiml a household. It Is not likely that children * ... *ditions of tlit price suppoit program for I.U. milk, for the 1973-74 marketing year be will Ingest the dried paint film. Having considered the reel guises nnd ginning April 1. 1073, Including the gen eral level of prices to pvodur.cn; for milk and the pliccs for and terms of purchase by CCC of butter, nonfat dry milk, nnd 2. The proposed { 3.------ Vitamin D preparations for oral use as drugs Is amended by deleting paragraph (b)(3), other relevant material, the Commis sioner of Food and Drugs proposes to exempt artists' paints nnd related ma Cheddar choose. Section 201(c) of the Agricultural Act. of 1019, or, amended, provides as follows: "The price of milk shall bo supported at such level not In excess of 00 per centum nor less than 75 per centum of the parity price therefor redesignating paragraph He) as para graph (d), and adding a new paragraph (c) to read as set forth below. 3.-------- Viiuniin II preparations for oi ol me a* drug*. terials from classification as a banned hazardous substance. If this proposal Is adopted these materials will still be sub ject to oilier provisions of the Federal Hazardous Substances Act nnd regula as the Secretary determines necessary tions promulgated thereunder. s In order to assure an adequate supply. Such price support shall be pi evicted through purchases of milk nnd the prod ucts of milk." Consideration will be given to any data, views, nnd recommendations which are submitted In writing to tho Director, <b) * * * (3) I Deleted 1 (c) Preparations containing 400 or less I.U. of vitamin D per dosage unit will be regarded ns misbranded If their recommended dally dosage exceeds 400 Therefore, pursuant to provisions of the Federal Hazardous Substances Act (see. 2(q) (1) (B), (2), 74 Stat. 374, as amended 00 Stat. 1304: 15 U.S.C. 1201 (q)(l)(B), (2)) and the Federal Food, Drug, nnd Cosmetic Act (see. 701(e), 52 Livestock nnd Dairy Division, Agricul tural Stabilization and Conservation Service. U.3. Department of Agriculture. Washington, D.C. 20250. In order to be sure of consideration, all submissions I.U. Dated: December 26,1072. Stat, 1055, ns amended; 21 U.S.C. 371 (e)). and under authority delegated to him (21 CFR 2.120), the Commissioner proposes that 5 191.9(a)(6) he amended must bo received by the Director not Inter Wil l ia m F. Ra n h o i.it i, by adding thereto a new subdivision than 30 days after publication of this Acffrig Associate Commissioner (1) (d), as follows: notice in the Fed er al Ur.orsran. All writ ten submissions mnde pursuant to this notico will be made available for public for Compliance. |FIt Doc.73-132 Filed l-3-73;8:45 amf 191.9 Hanned hazardous Mill,tames. (a) * Inspection at the Oillec of the Director din ing regular business hours <8:15 a.m4:45 p.nr.). (7 crat 1.27(b)) 121 CFR Part 191 ] lit Ml) (d) The provisions of this subdivision Signed at Washington, D.C., on De BANNED HAZARDOUS SUBSTANCES i (1> dt> ,,ot t0 artists' paints nnd cember 22, 1972. Rrclated materials. Gr enw A. Weir , Aclinp Executive Vice. Presiden t. Commodity Credit Corporation. |FR Doc.73-126 Filed l-3-73;8:4fi nra) Proposed Exemption of Artist*' Paints [3 . , , , anti Related Materials * Publication of this proposal in tho Fxn- An order was published In tho Fed er al f .r al Rrorr.xT.a Khali have tho effect of Reg is t er of March 11, 1972 (37 F.R. suspending the Implementation dato,(Dc- IEDERAL REGISTER, VOL. 38, NO. 2--THURSDAY, JANUARY 4, 1?Z3 /, K'1 ; . vt I J' V MU / GLD007H8 N 2260.07 MO PROPOSED RULE MAKING cctnber 31. 1972) of 5 191.9(a) (6) <i) <b) staled that existing VFR minimum* are Several other comments nuggrsted only rs it applies to m usts' paints mid re adequate. Despite ttie fact that views that Dio minimum* should be Increased. lated materials, pending review of com were /solicited on the adequacy of nil Some favored an Bcrors-the-boiud visi ments and promulgation of on order In minimum* in controlled airspace below bility requirement of 3 iu IIc h wl'li no tills inn Iter. Tills proposal will In no way 10.000 MFir., many comments were de change in the existing "clear of cloud;." affect the Implementation dote of 5 191.- voted solely to opposing the results of a requirement below 1.700 ferl AU1,. 0(a) (C) (1) (hi ns it applies to oilier points pilot survey which indicated that some Other* suggested same liilninod'inlo or nnd rimllor surface-con tine, mntci in Is. individuals favored an increase in visi sliding scale of visibility value;), .hi!" a Interested persons tuny, within f>0 days bility from 3 to 5 miles. F.inco many of few recommended some form of c!"ud after publication hereof in the Fungi:*!. the comments were picoccupird with clearance erlteiin in uiKoulioll d air- Ifreisrtn, file with the Hearing Cirri:, tills one issue, the amount (if InforninUan Fpace below 1,200 feet. Jn addition, sev D.T'Ttmcnt of Health, Fducntion, ami submitted on oilier aspects of the eral commentators noted Die <cuipli f lt.y Vv'clfare, Itouin G fin. 5(10(1 Fishers T.oue, ANFRM, Including distance from rloud of Die existing weather iii'iiitn'iio- 'Flic Rockville, MJj 201152, written comincnla requirements, was small. This notice is FAA agrees Hint the present it"r are (preferably In aulnlojilicnte) regarding Issued to obtain more adequate public complex, p.nd tliat one of (Ik >- pH tills proposal. Comments may be accom comment with respect to distance fiom eating factors is the "clear or .' 'mV' panied hy a memorandum or btief in cloud Toquimnrnts. requirement outside ci'ilicM'd par: support thereof. Received comments may II. Within controlled airspace. There at and below 1,290 feet above D' ': (are. he seen In the above ofTire (hiring working was overwhelming opposition to Increas The proposed amendment, in e<i'ii,i:n to liouis, Monday through Fiidny. ing VFR minuiumis In controlled air responding to safely eon.diioi cl Ions, Hated: December20.1972. space. As indicated above, a large pro would eliminate this fact-u. portion of the ronminnts was ditocted to As several commrnls 111 < i if-.p * - a. ie Wir.LriiM F. TlANnor.rir, the Issue of whether or not In increase qutrrmcnt to avoid clouds by a m-detotr Acting Associate Commissioner /or Compliance. the visibility minimum to 5 miles (below distance could prevent a pilot I rum In30.000 feet), (.`ommeiitutois eonsidcicd (idveilentl.v entering cloud* since Die IFTt Doc.73 20 Filed 1 3 72,8:45 mj this unacceptable for two reasons. First, distance between being "clem (f" clouds they stated that tlio estimated vesti lotion end "in" clouds Is slight. Bpoollvinn a to all kind;; of general aviation activity moderate minimum distance would iu- DEPARTMENT OF would he very serious, due to the poor triulurc a new safely fnclor hi Ilia \Tlt vislhilily prevailing in many parts, of the rules outside of coni l oiled ah 'pace. TRANSPORTATION United Slate,-; n large portion of the time. Since Notice 71-21 covered many Second, they stated that a visibility mini areas and the responding eommciil-; were Federal Avialion Administration mum of 5 miles would not. In itself, en necessarily somewhat fiagmeuird. the able a pilot lo see end avoid nnolhcr air FAA believes that the public should have I 14 CFR Part 91 ] |Docket No. 11350; Nolice No. 72-35] craft any sooner than v/Hli 3 mile;; visi an opportunity lo ferns on Ibis nuc bility, bemuse, they si.ot.cd, It is almost aspect pf the VfR mlnhuums. In addi impossible to see a small aircraft 5 miles tion to tiro subject metier of Ill's pro VFR WEATHER MINIMUMS away. posal. there are other subjects clDirr dis Rule making on the visibility aspects cussed in the ANPRM or genrrolcd hy Notice of Proposed Rule Making of the ANFRM is being deferred for fur it that are receiving consideration end The Federal Aviation Administration Is considering (unending Fart 91 of the Federal Aviation Regulations hy revising 5 91.105 to prescriho distance from cloud minimum* for aircraft operating 1.200 feet or less above the surface outside con trolled airspace. Interested persons may participate in the proposed rule oinking by rubind ting such written data, views, or arguments, ns they may desire. Communications .should identify the regulatory (locket or police number nnd be submitted In triplicate to; Federal Aviation Adminislrn.lion, Office of the General Counsel, Attention: Rules Dock cl. AGO PA, Alin Independence Avenue n\V., Washington, DO 20591. All coruniuiilcatioiir, received on or before March 22, 1973, will lie considered by the Administrator heroic taking action on the proposed rule. The proposal con tained in this notice may lie changed in the light of comments received. All com ments submitted will bo available, both before and after the closing dale for comments, in the rules docket for exami nation by lnlorcstod perrons. I. Ilar/.aromnt. This notion of proposed rule making follows advance notice of proposed rule, making (AMPRM1 71-21 <3G FR 17052) which was Issued on Au gust 23. 1971. That. AN Fit M was Issued to obtain comments on the adequacy of existing basic VFR weather minimum-; below 10.000 feet MRU in controlled and uncontrolled airspace. ther study of these comments, partic ularly since nvatlabln slotl.-.t.ies indicate (hat most near midair collision Incidents occur dining daylight hours and wlirn the visibility is in excess of 5 miles. This would Indicate Hint a mere increase tn visibility mlnllnmns may Involve an in creased burden on tiro airspace user without a corresponding increase in safely in controlled nlrsparc. HI. Olltfhlc controlled airspace. There were few comments directed specifically to adequacy of ntioimums in uncon trolled airspace. The majority of t.hcso stated tliat the minimum* are adequate and no changed are necessary. However, some coiinnonlntorF, did support more re st! ictivo requirements. The National Trnnr-ppi'tatlon Safely Hoard (NTFS!!) commented tlint in many instances un controlled airspace is utilised for train ing, transition and aircraft familiari sation for new or low-time pilot:;, that these activities plus a low-experience level inherent In training activities tend In increase hazards, and that therefore rteafer ciourl clearance and visibility should be required. Hie UTPB slated lluil, the weal her minimum* in uncon trolled airspace should tie the same as tlm a- In coni rolled nil spare below ) 0,900 feet,. 'J'lie FAA I". giving due considera tion to all aspects of tills recommenda tion, and believes that the Board may be correct with respect to distance from clouds nt and below 1,200 feet, outside which may lead to future proposals. In consideration of Din foregoing, il ls proposed to emend Fait 91 of Dio Fed eral Aviation Regulations h.v nmnidiiig ? 91.105(a) by deleting, from Die lahic. the word;; "clear of clouds" and by .sub stituting the word* "500 feet tie!civ,". "1,000 feet above," nnd "2,009 feet hori zontal," therefor. Tills amendment is proposed under Die authority of (actions 307 end 31.2(a) of Die Federal Aviation Act of 19."'3 (49 U.S.C. 1343, 1351(a)), nnd section G(c> of the Depnrlmctit of Transportation Act (49 U.S.C. 1055(c)). Issued In WasliliiRton, D.C., on Decem ber 22, 1972. Wn.i.UM M. Fi.zriF.n, Director, Air Traffic Service, |FR Doc.73 144 Filed 1-3-73:8:45 nm] fcdernl Highway Admiuisliciliou [ 49 CFR Pail 393 1 [Docket No. MC-22; Notice No. 72 251 MOTOR CARRIER SAFETY REGULATIONS Vehicle Interior Noise Levels Tlie Director of the Bureau of Motor Cnvrler Safety proposes to amend tho motor carrier safety regulation* to estab lish a maximum Interior sound level for Approximately GOO of the 730 com controlled nlrsparc. This notice request* commercial motor vehicles operated In ments received In respons.e to the notice further public comment on this point. Interstate or foreign commerce. ill a)' IV' \[j v ^OFRAl REGISTER, VOl. 38, NO. 2--THURSDAY, JANUARY A, 1973 !i l 'j GLD007119