Document EQeEe77Jnk590a0Q5wm17ggL

CHEMICALS AND PLASTICS N. L. ZUTTY Til. <a2) 8BI-MB7 OAT*: {J/'l&Ll I I II I tfl M Jfifj u^L^Joa phT AX'X Gcw-f) RECEIVED MAR I4 1974 R. N, w,ii ^ 270 MM AVENUE, NEW TOM, A V. 10017 ucc 029632 t * u, c rj sF? A)L Fl* 28 1974 THE SOCIE/t't.^lJj^E PLASTICS INDUSTRY, ,NC^ ^ 2SO PARK AVENUE NEW YORK. NEW YORK 10017 E1E/M7- Ay ' udlQ^ >/vV.February 21, 1974 'A'Acfi .------fl-{J -Or. V. L. Larson ' J Carbide Corporation Chemicals & Plastics 270 Park Avenue New York, New York 10017 f - '/1A,x "0 AvV -- Dear vem: THE FDA's PRIOR SANCTION OP PTC IS IN JEOPARDY UNLESS YOU ACT AT ONCE*. This is not a "scare1' headline to attract your attention. The FDA has raised a question about the carcinogenic effects of VCM used in PVC packaging, and it wants S.P.Z. to provide it with toxicological data. The attached report which was prepared by a special task force chaired by Art Sheldon of N ( I spells out in detail what is needed. Should the FDA withdr the prior sanction, the fallout of this action if>on PVC products other than packaging oould be sihstantl&l. The companded vinyl used as seating in autoocbilea and furniture could cone wider attack. PVC pipe would probably be attacked by its natal pipe competitors. Realizing that the present situation affects the entire PVC indtmtxy. Ran Michel, Chairman of the Ad Hoc PVC Liquor Bottle Committee, in consultation with S.P.I., has proposed that a separate ad hoc oanmittee be established to Monitor the proposed testing. It ia only logical that PVC resin producers staff this cosnittee. The bottle producers are primarily interested in the 90 day feeding test. Of course, son fabricators have a large interest in PVC packaging and they nay wish to sivport the two year study. We cannot eiphasize the need to nerve ahead with the feeding studies just as soon as passible. In order bo avoid delay by trying to determine \a^an what baais we should assess four different classes of interest, we propose that you indicate on the attached form your degree of interest in the PVC industry. SJP.X. will than equitably assess you on the basis of your reply. We estimate your share would be $6,000 to $10,000 for the two year study. The cost will be spread over a two year period. ucc 029633 Dr. C. H. Neher, Ethyl Corporation, has bn asked by S.P.Z., and he has agreed to chair this net# Ad Hoe ccnnittee. the Ad Hoc PVC Liquor Bottle Comnittee, with the formation of this comnittee, will stay in existence, but will discontinue further work in this area, should the new ad hoc comnittee need their assistance, the Ad Hoc PVC Liquor Bottle Comnittee will aonvene. Assuning that this will not be needed, we anticipate that the Ad Hoc PVC Liquor Bottle Comnittee will not have to meet until the new ad hoc oomnittee has completed the 90 day feeding studies and it is ready to report its findings. Please cooplets the form and return it no later than March 1, 1974. The EDA is waiting for our response. Should you have any questions, please contact me. If we don't hear from you by March 1, you'll hear from us. Cordially, WMcG/pb Thomas J. McGrath Director of Peckaging Services ucc 029634 THIS tjettbh WAS SENT TO THE FOLLOW!HG INDIVIDUALS: Mr. Herbert J. Kandsl American QaMeil Corporation F. O. Box 9247 2112 B. 223rd Street Long Beach, California 90810 Mr. R. J. Ventrea Borden Chemical Conyany SO Meet Broad Street Oolnnbua, Ohio 43215 Mr. Harry B. Connor*, Jr. Dimond shamrock Chemical Co. Diamond shamrock Bldg. 1100 Superior Avenue Cleveland# Ohio 44114 Dr. C. M. Haber Ethyl Corporation Plastics Division 451 Florida Baton touge# La. 70801 Mr. T. C. Walker Firestone Plastics Conyany P. 0. Box 699 Pottsteam. Pa. 19464 Mr* Jean P. Malone B. P. Goodrich chemical Co. 6100 Oak Tree Blvd. Cleveland# Ohio 44131 Mr. W. P. Christopher Hooker Oiemical Corporation 1515 Simmer street Stamford# Connecticut 06905 Mr. Jack Jaglo The Pantasote Cm. of wm Boric 26 Jefferson street Passaic# Has Jersey 07055 Mr. H. W. Holts Stauffer Giemical Conyany Plastics Division Westport# Ct. 06880 Mr. 0. B. Disch Tenneco Chemicals# Znc. Intermediates Division P. 0. Box 2 Turner Place Piscatasey# Mew Jersey 08854 Hr. V. l. Larson Union Carbide Corporation Chemicals C Plastics 270 Park Avenue Hew Yoric, Hew York 10017 Mr. S. Salem General Tire a Rubber Qo. Chemical/Plastics Division P. O. Box 951 Ikxon# Ohio 44329 Mr. R. B. workman Goodyear Tire a Rubber Co^any 1144 B. Market Street Akron# Ohio 44316 Mr. Curtis w. ColIyer Olin Corporation Desiyted Products Division 120 Long Ridge had Stamford# Ct. 06904 Mr. Robert L* Knapp Ubiroyal Chemical Division tkilroyal# znc. Spancer Street Wangetudc# Ct. 06770 Dr. A. R. Adame Air Products a Chemicals. Znc. five finetttive Mall Swedaaford Bead Wayna# Pa. 19087 ucc 029635 Hr* Mm S* Ert*l Pobantach 1407 Taxaa Street Fort North, Taxaa 76101 Mr. J. F. Gabbett Conoco Chanicala Coupany Continental oil Coapany Park 80 Plaza S Saddla Brook, Nant Jazaay 07662 Hr. Karl A. Hodischwender Amarican Hoadiat Corporation Stoat* 202 - 206 H Sonervilla, Ha* Jaxsay 08876 Mr. Alas KauMan N. R. Graca a Coupany Hatoo Chanical Division P. O. Box 27 Toxda, Haw Jaxsay 08863 Mr. . J. tbgal Jteynolda Hatals Coapany Packaging Division 6601 W. Broad Street ttdwond, Va. 23261 HP. Joaaph L. Downey The Dow Owmieal Gcwpany 2040 Dew Csntar Midland, Michigan 48640 a Mr. K. I.. Mai Shall Chasical Company Div. of ShsU Oil Co. Polysaxs Division P. 0. Box 2461 Bonaton, Taxaa 77001 Nr. D P. N*dal PPG Zndmtxlas, Me. Pittah*igh[ Pa. 15222 Pag* 2 Nr. Jack L. Shafar Maxbon Division Borg-Wamer Corporation P. O. Box 68 Washington, W. va. 26181 Mr. Martin P. Bratl Bohn a Haas Conpany indapandanca Mall w. Philadelphia, Pa. 19105 Mr. J. M. Moral Cincinnati Milacron Chemicals, Inc. Hast Street Beading, Ohio 45215 Mr. M. Kohno Kanaka Amriea Corporation 919 third Avenue New York, Hew York 10022 Hr. Al Keller M a T Chemicals RahRMy, Haw Jaxsay 07065 Mr. Frank M. Harris Aim Packaging, Inc. Erie Industrial Park Port Clinton, Ohio 43452 Mr. William J. Smith JmerLcan Can Company Mexican Lane Greenwich, Connecticut 06830 Jfr. William 8. Rlsch Andior Hocking Corporation 189 Container Place Springdale, Ohio 45246 It. Kenneth J. Auer Cslluplastica, Inc. 55 Worth street Fitchburg, Maas. 01420 ucc 029636 Hr. Kenneth G. Mldial Continental Can Conpany, Inc. Plastics Containar Division 633 Third Avenue Haw York, Haw York 10017 Mr. L. L. Otterson Dura-Containers, Inc. 3424 West 48th Place Chicago. Illinois 60632 Mr. Hobart P. Kittzedge Pabri-Kal Corporation 3303 B. Cork Street Xalamasoo, Michigan 49001 Mr. D. K. Parson Karr Glass Manufacturing Oorp. Packaging Products Division P. 0. Box 4000 Lancaster, Pennsylvania 17604 Mr. Clesent J. Comay Marquis Products Co., Inc. 931 B. Convent Street P. O. Box 52452 Lafayette, La. 70501 Mr. C. Malcolm cooper Owens-Illinois, Inc. Plastic Products Division P. 0. Box 1035 ft>led, Ohio 43601 Mr. J. P. Bennett Trio Products, Inc. 250 Vardan Avenue Elyria, Ohio 4403B THE SOCIETY OF THE PLASTICS INDUSTRY, INC. 250 PARK AVENUC NEW YORK. NEW YORK IOOI7 2J2/SS7-267S RET0R1I WO LATER THAW MARCH 1. 1974 TO: Mr. Thosias J, McGrath, Director of Packaging Services The Society of cha Plasties Industry, Inc. 250 Park Avenue New Yozk , New York 10017 1. Our coapany has an interest in VQi ( ), PVC resins or compounds ( ), additives used in PVC ( ), PVC packaging ( ). (please check areas of interest) 2. Ve will support the: a. 90 day feeding teat ( ) b. 90 day feeding teat In tends* with a two year feeding test ( ). 3. Ve wish to participate on the ad hoc coMtittee ( ). Our representative will be . Ve understand that . 55S) our financial obligation will not exceed- $10,000. tf eifw APIN0KI2EP SIGNATURE ucc 029638 Report of Ad Hoc Liquor Bottle Committee Task Group_______ The Task Group met on January 24, 1974 to consid r the problems involved and to attempt to develop a protocol for a feeding study for vinyl chloride monomer (VCM). The Committee is recommending that a 90-day feeding study with rats be con ducted, in tandem with a lifetime feeding study (two year study) for the reasons discussed subsequently. The Committee is also providing details about alternate test possibilities. The major problem involved in devising a feeding study for VCM is that the monomer is a gas at room temperature, volatilizes rapidly from conventional feedstocks, and thus poses a problem in determining exactly how much material the animals are eating. There is no problem in getting the animals to eat some vinyl chloride monomer but for a well controlled feeding study it is essential to feed known quantities at dif ferent dietary levels, and it is to proposals for the solution of this problem that the Task Group directed its first attention. The following chart shows the several possible ways in which the vinyl monomer might be incorporated in the rat diet in a measurable way: Method Comments Directly into food Possible chemical reactions Dissolve in Oil and encapsulate Oil loses VCM rapidly Dissolve in water Soluble to about It; does not evaporate quickly Direct, intubation Possible for 90-day study Absorption on Activated carbon Holds VCM without loss In evaluating these possibilities, the attempt to in corporate vinyl monomer directly into food was rejected be cause of the possibility of unknown chemical reactivity. Although it was found that the vinyl monomer evaporated rather rapidly from edible oil in preliminary tests, the pos sibility of developing a suitable encapsulation technique whereby ucc 029639 2 oil saturated with monomer c uld be encapsulated in a coating through which the monomer could diffus at a known rate sh uld be considered. The monomer was found not to evaporate very rapidly from closed water systems but the problem connected with the rate of monomer evaporation from the exposed drop at the end of the rodent sipper tube will require careful study. Further more, there is a question as to whether sufficient monomer can be administrated via water, but here the possibility exists that the solubility of the vinyl monomer in water may be in creased through the use of some harmless additive. The possibility of employing direct intubation involves a technique which has been used, but which poses well known problems of animal trauma which may complicate the interpreta tion of any results. Furthermore, this technique is considered of only dubious value for a possible long-term study. The final suggestion involved the absorption of vinyl monomer on activated carbon and the administering of such carbon as the source of dietary VCM. This approach has been : shown to be feasible for administering large quantities of VCM, but it remains to be shown whether the VCM absorbed on carbon will be biologically available to the rats, i.e. whether theVCM will be desorbed from the carbon after the animal has eaten the material. Here the possibility exists that carbons of varying absorptive power and ease of release may provide a useful balance of properties to make the approach practical and useful. The first recommendation of the Task Group is that the carbon absorption procedure be investigated with particular respect to the quantity of VCM that could be administered and the rate of desorption. ' This can be done initially in vitro with final confirmation assured by direct feeding stu3i.es with a radio-carbon tagged VCM. & second screening approach that is recommended for study involves the use of water or water plus an additive. This should be studied by monitoring the evaporation rate from the exposed droplet, with consideration being given to the total amount of VCM that can be administered. Here again after the in vitro studies have been completed, the results should be confirmed by feeding studies with a radio-labeled sample of VCM. & third possibility will involve encapsulation of an edible oil containing dissolved VCM. The feasibility of this approach will be considered by one of the Task Group members ucc 029640 -3- whose company is experienced in this general technique. Based upon the conclusion of the laboratory, the question of further worn, on this procedure should be considered. When the results of these screening experiments are available, it should then be possible to develop a plan for incorporating known quantities of VCM into the diets of rats. This may require daily preparation of the food and will almost certainly require frequent monitoring of the feed to provide a firm measure of the actual concentration in the animal's diet. When this has been done, a full protocol for a feeding study can then be submitted to the Food and Drug Administra tion for its views, following which the study could be initiated. In previous conferences, the Food and Drug Administra tion has indicated that the results of a 90-day feeding study should be submitted to supplement the "no migration" position set forth in the Comments filed by SPI. However, in light of the implication of possible carcinogenesis, this Committee feels that lifetime feeding studies will be required to pro vide long-term insurance against "future shock". For this reason we believe that the required 90-day feeding study should be supplemented by a lifetime feeding study, often called a two year feeding study. We estimate that a 90-day feeding study would require approximately $75,000 allocated as follows: WORK Feasibility and biological availability 90-day Rat Study Contingency TOTAL MONEY $25,000 $40,000 $10,000 $75,000 TIME TO COMPLETE 3 months 6 months 9 months te $40,000 allocated to the 90-day rat study is significantly higher than is generally encountered in an ordinary feeding study. However, this figure is suggested because of the very strong likelihood that extensive and frequent analytical work will be required, as well as daily preparation of feed for the animals. A two-year feeding study of the type envisioned by the Task Group is estimated to cost approximately $150,000 allocated as follows: UCC 029641 WORK Feasibility Lifetime feeding study Contingency TOTAL MONET $25,000 $100,000 $25,000 $150,000 TIME TO COMPLETE 3 months 33 months 36 months The feasibility study would be the same as that required for the 90-day study. The estimated cost of $100,000 includes the consideration that frequent make-up of feed and extensive analytical monitoring will be required. It is possible to combine the 90-day feeding study with a two-year study by including the animals needed for the 90-day study (which will be fed at a higher dietary level) along with the animals used for the two-year study. It is estimated that the cost for such a tandem study will be ap proximately $170,000, that is, more than the two-year study alone, but somewhat less than the two studies conducted one _ after the other. Furthermore, by this tandem arrangement both the 90-day study and the two-year study will be available in the total elapsed time of three ydars, whereas if they were conducted sequentially the final results would not be avail able for approximately 3 3/4 years* In either case, however, the 90-day study would be available at the same time. The Task Group recommends that this work be assigned to Food and Drug Research Laboratories, (FDRL), 60 Evergr en Place, East Orange, Mew Jersey. The full details' of a protocol for the feeding study will be prepared by FDRL before February 15. It is expected that FDRL will also prepare a critique of the Viola paper pointing out that the study, as conducted, is not scientifically appropriate as a means of evaluating the oral toxicology of vest. This Task Group would like to point out that an ' appropriately selected Committee should make appropriat arrangements to monitor this work since it is the opinion of the Task Group that this function is outside its scope. Turning to other points raised by the Food and Drug Administration during its conference on December 20* the Task Group recommends that the Ad Hoc Liquor Bottle Committee Ucc 029642 5recommend that vari us resin suppliers and bottle manufacturers begin long range studies at 72*F with water, dilute acetic acid, 8% ethanol, 50% ethanol and edible oil. These various solvents should be stored in bottles made from "new" compounds of known residual VCM levels and should be analysed periodically for at least nine months. In addition, efforts should be made to obtain samples of food such as vinegar, edible oil, and peanut butter presently packaged in "old" compounds and avail able in stores throughout the country. The food should be analyzed for VCM content as requested by the Food and Drug Administration. With respect to the questions raised regarding the referee procedures, Continental Can Co. and M & T Chemical Co. will be conferring in due course with the Food and Drug Admin istration Staff to resolve the questions. With the presentation of this report this Task Group feels it has now discharged its responsibility to the Ad Hoc Liquor Bottle Committee. Respectfully Submitted, Arthur Sheldon ucc 029643 1 MEMBERS OF TASK FORCE Continental Can Company 633 Third Avenue Mew York, Hew York 10017 John E. Farrell Continental Can Company ' 7622 S. Racine Avenue Chicago, Xllinoia 60620 Charles J. Splegl Ethyl Corporation 651 Florida Avenue Baton Rouge, La. 70801 Vllliai E. Rinehart Food & Drug Rea. Laba Wevnrly, New York K. Morgareldge Keller and Heclnan 1150 17th Street, N. V. Washington, D. C. 20036 Jerone H. Heckman D. S. Dialer i M & T Chemical* Znc. F. 0. Boa 1104 Rahway, New Jeraey 07065 A. W. Sheldon Stauffer Chemical Co. Westport, Ct. 06880 A. B. Lindquist -. Society of the Plastics Industry, Inc. 250 Park Avenue New York, Mew York 10017 Thomas J. McGrath ucc 029644