Document Z3rGV7QEE3aBgnZmeXxKd4rY

INTERNAL. CORRESPONDENCE ICNIE:MICALS AND PLASTICS To {Nqmol Olvh1loft Mr. J, L. Carvajal Dr. C. U. Dernehl, NY0-4 Mr. M, E. Eisenhour, 515 Dr. Kenneth S. Lane, NY0-4 Dr. A. B. Steele, NY0-2.8 Dr. N. L. Zutty I Mr. R. E. Gulick, NY0-32. =SOUT!I ClfAitlmllN 'lAllT P. 0. BOX 8004. SOUT!f C!IAftl.mOII. W.VA. May 31, 1973 S.blo<t Manufacturing Chemists Association Vinyl Chloride Research Projects The Vinyl Chlor"ide Research Coordinators met on May 2.0, 1973 at 9:00 P.M., followed by the sponsoring industries' Technical Task Group on Vinyl Chloride Research meeting at 10:00 A.M. on May Zl, to coD,aider the banning o polyvinyl chloride whiskey bottles by the FDA and the proposed vinyl chloride data presentation to NIOSH. A copy of the proposed rules !or the Federal Register banning poly vinyl chloride resina !or use in plastic whiskey bottles ia attached, Dr, T. R. Torkel8on, in calling the meeting, said the ban was the result o no established human tolerance for vinyl chloride monomer in food, the published work on tumors in rata by Viola, and the announced inhalation study by MCA. Other comments, at the. meeting, were that FDA would not ban the bottles under the so-called Delaney Amendment because the published inhalation work by Viola was not considered a suitable test by FDA. Dr. B. M. G. Zwicker o Goodrich insisted that the mode of bottle fabrication or the type of resin had no bearing on the dissolved monomer in the bottle. Other discussion, at both meetings, centered about the forthcoming presentation of vinyl chloride data to NIOSH. Dr. David Du!!ield !rom ICI represented the European vinyl chlo,;ide group. Borden, Exxon, Uniroyal, British Petroleum Chemicals, Goodyear, Monsanto, and Olin were not represented as sponsoring companies, The question as to who approved the plana !or the NIOsH presentation was raised, diacusaed vaguely, and tabled as being out of the group's province: The MCA letter to company executive contaC:ta, dated March 2.6, 1973, .which assumed consent i! no reply were made, was cited as authorization. Two replies were received- one favorable and one unfavorable. The need !or the NIOSH presentation was discussed with the following pertinent points noted: ucc 004983 r , . . - ----- - ----- ------ 2. ( 1. The MCA letter to company executive contacts, dated , March 26, 1973, could be construed as evidence of an illegal conspiracy by industry if the informa.tion were not made public or at least made a.vailable to the government. z. Ii the interim results of the Europea.n annual study were made available, the timing might be appropriate for the presenta- tion to NIOSH. 3. Ii the interim results of the Europea.n annual study were not available, i.e. released by the study sponsors, then the presentation to NIOSH ahould have been ma.de la.at year or earlier. Dr. David Duffield was preoaured a great dea.l by the Chairman, . Doctor Torkelson !rom Dow, to secure permission from the European project sponsors to use the interim data. Doctor Torkelson reluctantly agreed to wait until July 1 for the permission. Doctor Duifi.eld promised to a.rrange a.n early meeting o the project sponsors to discuss the gra.nting of the desired perrniaaion. Pa.rtic:ipanta in the proposed presentation, in June, are: . 1. Dr. M. Key, Director of NIOSH and others he ma.y suggeat, z. Dr. K. D; Johnson and/ or Mi. George E. Beat o MCA 3. Mr. V. K. Rowe and Mr. 0. J. Williams of Dow 4. Mr. Anton Vittone or Mr. T. B. Nantz of Goodrich 5. Mr. H. Kunetz of Shell 6. Dr. c. u. Dernehl of Union Carbide, Doctor Dernehl and Doctor Johnson were the only repreentativea at the meeting. The prenntation would lollow this general outline:, A. A listing o the twenty U.S, com:Panie aponaoring the MCA work. IJCC 004984 B. Description o! the Industry 1, Monomer Production (U.S. and World! a) Volume in pounds b-) Producers c) Number o! exposed workers 2, PVC and Copol'(Iller Production a) Producers b) Uses and volume o! each uae c) Number o! exposed workers C, Toxicity Studies - History l, Pa.at toxicity studies. 2, Pa.st epidemiological studies - acrooeteolysis, 3. Work reported by Viola, 4, Unpublished European Work Viola's current study and the European consortium study. D. Toxicity Studies - Current 1. MCA toxicity study protocoL 2. MCA epidemiological study protocol. 3. European consorti= study protocol. 4, Viola's current study protocol. 3. UCC 004985 E. Recommendations for Action 4, 1. Control a) Industry would adhere to a ZOO ppm TLV or TWA limit and would work toward lower levela, b) Industry would monitor extensively the exposure levels of workers. (Dow and Goodrich insisted the monitoring should be continuous and recommended a Davis combustion conductivity or a Davis halide meter, Other devices mentioned were I. R. absorption with a. 10-meter (?) cell or vapor phase chromatography, Dow promised to supply data on these instruments.) z. Establish working contact a.t NIOSH. 3. Future research none pending results o! ongoing work. Pouible studies are dose response for carcinogenic action, the effect of VCl on (.SH), and metabolism, This outline is to be a guide, but the representatives at the meeting will have wide latitude in the itema discuued<' Items specifically removed !rom the proposed presentation or discussed and not used are: 1. Dow epidemiological study- study of a limited group of Dow workers showed a. 0.08 probability of canc.e.r .. o. 1, considered significant. The control group, however, showed 4. 2 cancers and the exposed group had 8. z. Dow air pollution work showed vinyl chloride had a half li!e z.of 4 hours in light, 5 times as strong aa sunlight. ucc 004986  5. 3, All references to use o vinyl chloride in aerosol propellants' were removed, since it is a minor part of the industry and is not a worker-exposure problem except for beauticians and can fillers. (This was removed at the insistence of UCC and Allied, but some effort to reinsert it in the presentation by the industry representatives is believed to be possible.) 4. The recommendation for a 50 ppm TLV or TWA was re moved because of the government tendency to reduce such limits by a factor of 10. UCC pointed out that manual cleaning o autoclaves could not meet the 50 ppm TLV, and that no resin plant could operate at a 5 ppm TLV. UCC also pointed out that the TLV for autoclave cleaning, recommended in the acroooteolyaia study, was 50 ppm but there was no data in the study to support the recommendation. The group generally agreed that the polymer industry did not presently have the ability to live within the 50 ppm, TLV. Other itema of interest picked up at the meeting were: 1. Air Products is planning a new emulsion resin plan in the east, but is currently stymied by environmental considerations. 2. The contract with Tabershaw-Cooper Auoeiatea for the industry epidemiological study haa not been approved by MCA, yet, despite the emergency sub- scription drive on April 6. ; MCA will try to give Taberahaw- Cooper a. letter of intent in May, it they can find the proposed contract. 3. Comments were heard that the M,CA counsel present at the meeting should participate in th" NIOSH presentation, since he seemed to be more knowledgeable , than anyone else. 'Hazard to UCC' a interests exists if vinyl chloride ia deelared to be a carcinogen or if vinyl chloride monomer is detected by FDA in foods exposed to vinyl chloride polymers as film, coa.tinga, or gasketing. Since no data exists ucc 004987 6, on the monomer content o solvent or dispersion resina, R&D has been requested to determine the monomer present in the resin. U this content is appreciable, then some investigation o fabricated films or coatings appears warranted, Currently, our answer to inquiriea ia to say we don't believe there can be any in coatingo, etc, RNWJr/ra Attachment be: Dr. D. H. Glenn, 515 Dr. E. Q, Hull, 5 14 f(JJ.tt/4) R, N. Wheeler, Jr. ucc 004988 PROPOSED RULES 12931 Copied by MCA 5/18/73 Amendment of 1958 and wbleh hu FDA lmows of no rtudJea .which eatab- wtdeiY used lince that tJme. Not 3.ll POlY a. sa.te level ot con.sumpuan when vinyl chlot1de !ormuJ.at.iona can })e used thi:s monomer is lea.th.eQ from CXJD.taJn In !oocl Po17'YtnYI chloride ers Into alcoho.Uc: food&. tb.e having a m..a.x:l.mum vola.tWty o! not O\'er Cornn:Usa1oner eoncludea that the use ot 3lOSpercce..nta.nwdhehnavhtne8a'teadn f or 1 hour at inherent \'ls- polyvinYl ehlor1de for pack&CI"I' &leo- holle Coed& ma.:y eau.so IUCh toocll to be eosfty of not less truLn O.llJ hen deter- adult.eratect. mined bY Amcdenn SocietY !ol' There la: no ind.l.eation &t th18 t.tm. that tng and Matert&ls CAS'I'l() standard pol.yv1nyl cb.lortde in eont&c'l With method D 1243-66. is prtor-sanettoned for use a.s & comPOnent of a tUm !or food. wrnp3 or a.a a ea.n enamel An tnlft'ed,1ent whose use in food or food pncka;1.nc is subJect to a nonall.:oholle foods w1l1 result tn tton of rnon'='tne.rs, a.nd such UM need not be l"e'\t.ricted.. Therefore, punuant to pf'OV1.Idonl ot the Peden.! Food, Druc', and Cosm.et1c tlon or 1\PProval wiUUn the meamn; of Act C.secs. 20lcs>, 402, 408, 101Ca>. 5.2 section ZOl (a) f.f) of the PederaJ Food. BUt. 1042. 1048-1047 u &mended. 1049, Drug, and Cosmetic Act ts extmpt from 1056; 21 U.S.C. 321(a), da&itkation aa & food additive n.nd ma.,y and under authority 371Ca)) to h1m be used Wit.hout pre-clea.ranee by PDA. (l1 CPR 2.1201, the Comm1w1cmer of The sa.netton for PVC rest& on a.u P'ood and Dtuss to amend. par\ t1cle entitled ''Food Pn.ck::ac:1nc"" by A. J, 121 by add.lna a new section 121.300t to Lehman. Chief of the OIT1s1on o! Ph.&r n!i\d as tollO"''n: emtaactoiloOnfDo"!, P'DA. Pood. aPnQd.bDlisrhuesd.Oltnrleti:h\1e8 "o. Ar &tIhoo- 12 1.-vv 7 p .......... Un1tec1 St&tts." volume 20, No. t. Octo- fa) Pol:rvtn71 cl1lortde COillls\ ber 1954. n 1a clev 1n tbe &rtt.cle til at o! ba.sie restna produced b1 t.be a.ecept.a.nee ol the rea:1ru1 a&m.ect therein zauon of Yin:Yl eb.lortde. . e.. ; .wu 'oued on their Jack ot m.tt:ratJon. <biPoln't.t17lehlotScSebuicZ'IIIII:Diha:,ft--tA,:.: when teoted for oolublllt7 In tho U.tecl maximum YOI&tlllt7 of 1>0t """" s solvent antema. The PQbUeatlon cited when heated tor 1 hour at 101 !!"' dJd not refer to c:hJor1de n.nd an inherent T1.scocltJ' of llOt leM thl.:ll and d1d not name '11 alcohoUe med.lum 0.35 when d.ete:rm.!necl b7 AEr'll. %Dtthod ).! a, a. test mt.em. arr 10, 1973. In JanU&tl' um. tho 1'ood and Drug <cl Pol>'l1n71 chiDrlde ....ma Admlnlstratton - to re<elve reJX>rta tho erlterl& o! <o.> ot J)<lll<lble ltoblllt7 probl..,. with PVC o! this seet1on m&J be Ullell u " com botUes uaec1 for di.Jtilled. IPiri"c& The. ponent ot food. paek&a'na" m&ter!al. iXbtll" p"""""'botUes were parl of an ezpertment&l than P&CUC:lnl' m.a.terW tor UR ta. con.. l!ni authortzed b7 tho TreMUT7 tact with aleohollc foodo. .8\m!au o! Alcobcl. Tobaeeo. and trtal Fui.sre.ra. ..o-t In tb.eet boWill !tel. IndtlS.-. end. an tuW .. .....'t'Ored. alcobol'c beYen.ce:l wb1c.h had been In - . Pt-el.lmlnot7 anal>'tl.-1 resulta 'ndicated that riD.J'l chloride m.oa.omer-, a. Hli'!)TX"Mmt of PVC. ..-.. ex- tncted from tho Inc . - . The varied., wU.b. taaolomt.h.eomUs.taqmuehop1rloedr.lu<Jrlne a h1&h ranee ol 10-20 p/m.. A'- that ttme DEPARTMENT Of HEALTH.t EDUCATIOH, AND Food lnd 0...,. [ 21 CJIW t'ort 121 ] I'OI.YVINYL CIII.OIIIDI! IIDIN Poi-YTID:rlo1ch"l"o"ri"d'e"""<P-VC> Mlaolliancpoly mtrfc Nl1n wb1ch 1VU \\"ltd u a ecm.DO- oml o! food l*""ccnc mo.ler!&1ll 1>11or 1o the - al the l'ood Addltl... ttnh&o&lreoulto 11&4 - -eumm-&t.Jon. b7 cIPa'&Dl Puhrr.eltcnoauelxlAl,pml1ItlDn&cltu,td.!.D,aw- u- o! pres e_-n.t:etdroto- PDA by lllduoiZ7 wblcl1 c:oo>llrmed tile ea.zi.7 ot '9'1n:fl monocuer b : n -Inracvevtowo 41atllled had splrtla. Theee In beY PVC boUlel tor U to 1 ,ear. Inf(Wn:ll;tJon n.s lllo reeetYed which repa&1.ed tha.t. '\'91ne - - In PVC bottleo wu almllarl7 afleet.ed.. P'DA hu now COI1ft.r'tMd. 1!11lct'&tJ.on of the monomer 1n di&Wled. JPirtta tn 1ts own laboral.o<7. WhUe aul:tt!cal teltl a.re contln\Wlc both at l"DA mnd in ln- daatrtall&boratorta to reeo.lft m&ll.J' un- l<l<:hnlcol questk>QI - t o lhla problem, It .....,. - - at thla t.1me that. vinl'l cb.Jor1cle atoD.omcr mi. "to' "" pa ' 1o .eta . alCohol from PVC bo<ll.,. uoed p di.st.llled spirits 8.Dd win... VtnyJ ehlortde mouocn.er u .such i.' poilonoua and deleterloua c -WD.l.w< P. R.un>or.n. Actil<o .u.oel4t. !PB Ooc.7J...1911 Pt*ll-1._71:a:t2 amJ Oftlceol- 411 CJIW t'ort 1111 J FtttANCIAl. ASSISTA#d FOil THE ll.f. -tlonP!IO\IEMINT OF tDUCATlOHAI. 01'1'011 TUNmQ FOil ADULT INDIANS to tho &utl>orlt7 CO<>t&!ned ir. te<llon 3U o! tho Adult as &c14ed. b7 put C of Utl.e IV of tbe Eduea.tica Am.rndmenta ot 187: Publle L&w t:i-311, H stat. 342, 20 U.S.C. 1211&), tho ('-ml'BI._. o! EdU w,.u,aao.! wHiathltltlh,oll'adipOp:&rotlonDl, oa!n"d"W' -ei!-, FHIIIAL IEGISTEI, VOL ll, NO. 95-llfUISOAY', MAY 17, it73 ucc 004989