Document EBYKp6qnrQrVnn26J8jngkKx

.msuri) T-; pi:;.Lr.3v uhKOMh J! /,'k: CUAKf.:.s yt kizt.1lak V-'UAJ/: M n : I r r .SA >'!.. U NOV.I-Jv'T If . TJ KK K f. K Wy.VKM V 11 i. A '' 1C )ja \'3 n l. Ill 1. K /. irr; v v. 11 r l:' `o\ m )' l'. I-.1 M . t` r. V l- : `V jcsrr1.! r. uai :.::v CaIi-oi,:-: ic: :s v. *UC3H P ITT 12 If T 3! O >1 J-. F S K 1T H 1*av o,rr*icr:s fAIT-HU a>Uj IISCH1.1AK n:o irTM sTiisn, >'. -w. sr:r}' 1000 av/.srryKr.TOiv. D-c. 20036 Octcbe." 10; 1914 / C - o \OQ~7 TTiT/I'VTjON'lI AiJDltKNS "Kri-MAV ` ' S?I Food, Drug and Cosmetic Packaging Materials Committee? General Polyvinyl -Chloride Interest Marling List; Ad Hoc Liquor Bottle Committee; risstic Pipe Institute (Executive Board) ; Plastic Bottle Division (Voting Representatives); EPI Executive Committee; ?I Puhlic A.f fairs Committee; VCM and PVC Producers Committee Ladies and Gentlemen: The October 7, 1574 issue of Food Chemical Mews carried an article which we have confirmed as being essentially correct noting chat the Food and Drug Ad ministration is evaluating a significant revision of its draft proposal concerning the use of polyvinyl chloride food contact plastics. The revision, as it has been described to us, since, obviously, we cannot obtain any copies of FDA's working papers, would seem to signal an important shift in the A.gency ' s current thinking. Un fortunately, FDA. appears to be moving towards a much harder line,- possible' because of the type of public acceptance it has seen of OBFIA.'s approach and a concern than it not evidence a less anti-industry or "pro-consumer image. In any event, we are told that the Food and * Drug A.dxrdni s tr ati on Staff is now considering eliminating the end use rest which would establish a maximum of 50 ppb of vinyl chloride in the rest solvents. Instead, it is EID10777 5 - 9- considering ramitxng single us FVC material to 1 cf residua.1 monomer, and repealed use materials suer pipe and tubing,to 10 9D!ii residual mcnomer. The rai advanced fo: : J J_ G >- Ti C -2 in "DA thinking is that no s to ^usItbifJvG- the Stf"v cf env VCM in Consequent] V / current FDA thinking is that even a level .as low a.s the 50 ppb maximum cannot be justified by any evidence in its files with resoect to safety. Hopefully, this lack cf information may be rectified to a degree by a report prepared by the Centraal Instituut voox Voedingscnderooek (The Central Institute for Nutrition and Food Research) in Holland. This organi zation conducted a subchronic (90-day) oral toxicity study with vinyl chloride monomer in rats at the request of the German Verband der Kunststofferzeugende Industrie e.V. (the German plastics industry trade association). Copies of this report have, been obtained through the cooperation and courtesy of Dr. Karl Koch s chwencler, American Koechst Corporation, and have been submitted to the Food and Drug Administration. We are enclosing a copy of our letter of transmittal to Dr. Schaffner; reproductions of the toxi- cological r port sent with the letter may become available in the n future but we are not enclosing one with letter b ecause we have not yet received Pp<ermission to duplicate to this degree. The letter to Dr. Schaffner contains a r print from Food Chemical News which is beirv: istributed to you- with permission cf the ublisher. The report indicates th vinyl chloride monomer, a dm.i Ti X cf e X 0 G t-. JV y 9 e0 S.V a as G s o ~! u tion in s oy o>i il, had a no- ^ -C - ec q 1 e V 1 c X c> 0 mg/ kg ! G n d had no c le ar 1' icxl c eff ec T s c. t s1 ev s 1 0 c high a s 0 0 mg/:kg do sage ^els . The dif f e X en 0 o 0b etw e T 0 n e s e tw o f gures ref 1 ects ac th 0 XV, X gh e 1 o V el s in f ac t 0 T 5 such as VXsJ lood liv er x\w oh y V-* r mi c rc C CO "0 i c an a m i T imal 0x 1 V T ch an ges e viden am ina -x on ; bu 0. *UV, 0 si gni fi c ar.ee unc-er : these fin di Ji os is no 0c 1 p v 9 Most importantly, no evidence of carcinogenic!* v;as detected nor were there any hi stopathoiogical changes to the auditor-/ sebaceous gland (Z-ymbal's gland) which is known to be or.e of the target organs cf vinyl chloride monomer administered by inhalation \) vv pi i ^=1 "N-./fAji. EID10778 we nor-e zt C j_c f rj n "i -- r Q ?*n 000 r 0 0 c. 0 c-. Ml. - rO V .Je mal >. c: j ~ < -,,J C-i. r ' o ~ -C- >c.0" form, cf tns - ' ro ^ vo sna2-_i "omv jo rosure EID10779 PV * / r*U n ^ :v