Document zQq135X813K76EEG8edd7gJYg

\'/ C RECEIVED MAR 2 0 1974 R. N. WHEELER. JR. / FROM: Robert W. Wesson NYO - 32nd Floor TO: Messrs. R. W, Annonio G. P. Bigelow t D. E. Hardman/ N. L. Zutty s Please forward the attached to the appropriate person or persons who may be affected. Dr. A. B. Steele has some later information than the attached if you would like to call him. /amh Attach-.- RWW From the. desk of ... . V. L. Larson \ March 15, 1974 To: Mr. T. W. Carmody Mr. A. W. Lutz Mr. R. W. Wasson^-" THIS REQUIRES URGEUT ATTENTION. VLL ucc 02961S THE SOCIETY OF THE PLASTICS INDUSTRY, INC. 250 PARK AVENUE NEW YORK. NEW YORK 10017 2I2/687-2G75 URGENT MEMORANDUM CONFIDENTIAL MARCH 12, 1974 THE ATTACHED LETTER FROM SPI COUNSEL, JEROME HECKMAN, REPORTS AN IMMINENT, CRUCIAL FDA ACTION VITAL TO ANY ONE CONNECTED IN ANY NAY WITH PVC, ITS PRECURSORS AND COMPONENTS. I URGE YOU TO READ IT IMMEDIATELY, AND TO CONSULT WITH ANYONE IN YOUR COMPANY WHO MAY BE AFFECTED. FURTHER, THIS LETTER IS ADVjANCE INFORMATION AND IS NOT APPROPRI.RTE FOR PUBLICATION. PLANS FOR RESPONSES TO THIS DEVELOPING SITUATION ARE UNDERWAY AT SPI. RALPH L. HARDING, JR. PRESIDENT ucc 029619 josepu E. KJCLLEH JEHOME n decuman1 CHAJu.r.s m.mekhanWILLIAM II. IJDIIOJIESANI. JH ROBEUT R.TIERNAN* WAYNE V. IJL/ t DAY II) L. Ill LI. MAbTIN W. DEliCOVICI EDWIN D SPIKVaCE PETER M NEMKOV JOSEPH Z, HADLEY CABOLE C. HAlliaS williah w ruon Law omens Rei-usk and Heckman uoo ir street, x. w. SUITE iOOO WASHINGTON, D. C. 2003G March 12, 1974 TELEPHONE soss aoo-ifioo CABLE AUDKCSS "KI^LMAS" TO: All Members of: SPI Food, Drug and Cosmetic Packaging Materials Committee; BATF Mailing List; Ad Hoc Liauor Dottle Committee; Plastic Pice Institute (Executive Board); Plastic Bottle Division (Voting Representatives); SPI Executive Committee; SPI Public Affairs Committee RE: Prior Sanctioned PVC Status; Proposed Rule Making Gentlemen: On March 8, 1974 a meeting was held between representatives of the Food and Drug Administration and the representatives of the PVC Task Force mentioned in our letter of last week. The.meeting was called at the request of-the Food and Drug Administration, ostensibly to learn what actions and plans the Society of the Plas tics Industry had to provide responses to the question ' raised at the December 20, 1973 meeting as they were set forth in the summary filed with the Hearing Cleric on February 5, 1974. Actually, the Food and Drug Administra tion used the meeting as a forum to disclose informally its intentions regarding the developing PVC situation. As soon as we assembled for the conference, it became apparent frem the stature of th e tom.icolcc'ists and others present that the Food and Drug Administration considered this to be a major regulatory matter and session. The meeting was held in the office of Dr. Virgil 0. Wodicka / Director of the Bureau of Foods. Dr. Wodicka was present during part of the discussion, but did not actively participate in it. Those present were: FDA Division of Food and Color Additives Mr. Richard J. Ren]:, Director Mr. Louis E. Buckley Mr. Gcrad L. McCov;in Division of Toxicology Dr. Leo Friedman, Director Dr. Herbert Blumanthal, Deputy Director Dr. Charles J. Kokoski Dr. Krishna P. Mirsa Division of Chemistry and Phvsics Mr. Albert Holtz Mr. Michael J. Clifford Mr. George Lnkata Division of Chemical Technolocrv Dr. Charles F. Jelinek, Director SPI Dr. Charles J. spiegl, Continental Can Co. Dr. Ivor L. Simmons, M & T Chemicals, Inc. Dr. Kenneth Morgarsidge, Food and Drug Research Laboratories Jerome H. Heckman, Esq. Keller and Heckman Dr* Daniel S. Dirler, Keller and Heckman Invited but not able to attend for SPI was William Rinehart of the Ethyl Corporation. The major problem as FDA now views it V.T2S ulS' cuss ed by everyone at length but was probably best summarized by Drr. Dlumcnthal. He stated that based upon the experimental wor conducted_______ _ - i - by both Dr.r- . _ r V_io1 l_a - and Dr.rs--. wajlto--n-x, cornuin**.c-*.e.7 with recent epidemiological evidence, it must be concluded that vinyl chloride monomer is a carcinogen. Further, he said it must be1 presumptively considered to be a carcinogen even when taken orally because the cancers that were formed uce 029621 - 3 *r after inhalation exposure were at a site far removed from the point of contact. In other words, the vinyl monomer had to be absorbed through the lungs and then transported to the liver where the angiosarcoma developed. Furthermore, the liver cancers were not caused by metastasis of cancerous lung tissue. Consequently, the Food and Drug Administration feels it has to assume in the interest of the public safety that the same possibilities exist for vinyl chloride tshen via ingestion. For this reason we were informed that FDA will shortly (within one or two weeks according to hr. Ronk) publish in the Federal Register a notice regarding poly vinyl chloride. In the Notice it is intended to review the entire problem I / means of a preamble. The discussion will conclude that the continued use of polyvinyl chloride for food contact purposes can no longer be considered safe with out some restrictions and limitations while the questions regarding its safely are being resolved by further scientific investigation. Consequentiv, the Notice will propose the following: 1. The prior sanctioned status of polyvinyl chloride resins will be revoked.. 2. An "Interim Too d Additive Regulation" will be proposed to permit the cent inuaa use of polvvir.yl chloride resins under conditions the t will assure that the public ^ will be exposed to no undue hazards. These conditions ray include a limitation on the residual vinyl chloride monomer content' in the polyvinyl ch leride food contact surface uo less than 10 ppm, and asour ar.oa that no vir.vl monomer will transfor to food using a do taction method sensitive to 50 ppb. 3. The Notice will st ate that a suitable toxicology protocol will have to be subr.i tted within sixty days. Actually, a protocol was submitted cn Na rch 5, 1974 (as will be discussed below) and this will be conoid ered as a first step tov;ard compliance with this requirume nt. In addition to the submission of a protocol, however, the call; carried out enpediz_ously and time li: i as for its com?la" and reporting to the Food and Drug Adr inistraticn will be set 4. Some system of reporting to the Food and Drug Administration will be required so that the Food and Drug UCC 029622 4 Administration can be assured that po.lyvin.yl chloride materials used in food contact applications do comply with the interim requirements (the possible less Ujrin , 10 ppm in the food contact surface and no detectable 1 vinyl monomer in food concepts). 5. Finally, the Kot.ce will state that no present urgent hazard exists so that no recall of presently packaged foods will be necessary. The Food and Drug Administration also made it explicitly clear that this order is intended to apply not only to packaging materials, but also to potable water pipe, and industrial and farm equipment that is used to transport food during processing, e.g. vinyl tubing used on milicing machines. Furthermore, it is altogether likely that this same set of restrictions will be applied to cos metic containers and drug containers. [It is because of FDA's explieLfcly and repeatedly stated intention to include within the sc:;po of the forthcoming order PVC potable water pipe as we.11 as any other FVC equipment that contacts foods or wate:r, we have expanded the mailing list for this letter to acd tlce Executive Board members of the Plastic Pipe institute.] We are attaching h oreto a copy of an informal letter which was delivered to the Food and Drug Administration on Tuesday, March 5, 1374. T his letter, sent at FDA's re- quest, was a point by point c iscussicn of the various questions raised by cue Food and Drug clv.inistrnticr. during the December 20th meeting. Eccausa of the shortness cf time between the FDA's request for the meeting and the date at which it was actually Ice Id, we wore unable to circulate a draft cf the letter, and you will recall y cu wore for*.: a mod of this in our letter of February 27, 1374 Since it was impossible to pre- pare a more formal presentati on and obtain the concurrence of the membership, it was recues fed that this letter be considered an iterna mo rancour. id the.A it nob bo placed on file at the Hearing Clerk's office, We were assured thab this would be so handled. On Friday the Food and Drug Administration did not give any critique of the protocol that was submitbed to it with the March 5th letter. However, since polyvinyl chloride ucc 029623 5 is to become a regulated material, the toxicology generally required in a Food Additive Petition will be required. These toxicology requirements were discussed ger.eraj.ly. Firstly, it was agreed that rats of the same species that Dr. Ilaltoni used were sensitive to vinyl chloride monomer, and. they should be used for the test for determining 'whether vinyl chloride monomer when taken orally would cause cancer. Since these rats are known to be sensi tive, a second species will not be required, although two species are generally required to assure that at lerst one sensitive species has been used. If the feeding study pro posed should demonstrate that vinyl chloride monomer, when ingested, causes cancer, the Delaney clause may become operative and no Food Additive Regulation can be written to permit the use of polyvinyl chloride for food contact pur poses if anv vinyl chlori e monomer were to migrate to food, Under th e " e circamstan:cos the test method sensitive to 50 nob would undoubtedly not considered sensitive enough; indeed, if carcinogenicity is proven , it is unlikely that PDA.would permit any use of FVC in food or water contact surfaces, this being its view of its obligation under the so-cailcd Delaney clause. On theother hand, if, as some feel it reasonable to anticipate, vinyl chloride monomer is given a "clean bill of health" when ingested then a Feed Additive Regulation can be written to permit the use of polyvinyl chloride even though vinyl monomer may possibly migrate to food. If a Regulation is proposed whereby the amount of vinyl monomer migrating to food is not detectable using a'.mothod sensitive to 50 ppb, the: it is possible that no additional toxicology will be required beyond that included in the two-year rat protocol already submitted. However, the possibility exists that it will be considered commercially desirable to request that detectable quantities of vinyl monomer be permitted to migrate to food. Under these circumstances, we have been informed that signifi cantly more toxicology will be required, possibly including tests of teratology, mutagenicity, studies on the metabolic fate of vinyl monomer when ingested and multi-generation reproduction studies. Although it was our original intention and expecta tion that we would be able to discuss the details of the ucc 029624 6 analytical procedures in light of the FDA requirements, no time was spent cn this aspect of, cur letter at the meeting. Actually, the meeting began at 1:00 and con tinued until after FDA closing time. During this time, information was given to the Toed and Drug Administration with respect to levels of vinyl monomer that could be expected in all kinds of food when packaged in the "new" compounds. Fur timermore, some fragmentary information was given regarding levels of vinyl chloride monomer found in random samples of feeds which have been packaged in poly vinyl chloride compounds some time in the past and analyzed recently. The Food and Drug Administration confirmed that it has already been informed by various European regulatory agencies that vinyl chloride monomer has been detected in a variety of foods packaged in Europe. The levels of VC.'l in food already packaged combined with the assurance that foods packaged in "new" compounds could be expected to shorn no vinyl monomer mi gration detectable with a method sensitive to 50 ppb, apparently encouraged the Food and Drug Administration to conclude that, (a), the present levels of e; osure did not require a recall, but that, (b) , continued use of polyvinyl chloride feed contact materials requires that thev be formu lated and processed in such a way as to assure that no detectable vinyl monomer will enter foods in the future. In view of the significance of the actions pro posed by the Food and Drug Administration, we wanted to transmit this report as rapidly as possible so you could have maximum lead time before the Food and Drug Administration publishes the new proposed rule making along the'lines which we have indicated. Obviously the latest developments we are reporting will require concerted action and, very likely, the bringing into play of parties not heretofore considered directly involved, e.g^. s"u"-p'''Opliers of pipe resins and pips man u f a c t v. r c rs. Ycv ;s sure cl that, very promptly, we, Ralph Harding and/or Tom McGrath, will be discussing the possibilities and means wherebv appropriate action and plans can be redo with v*0-- leadership, including people like Fan Michel, Clarence Echor, Dryce Datzer, and Earl Kochschwer.c'er. Thereafter I am sure vc will be in touch with you, possibly to call a very large meeting as soon as the anticipated !JCC 02962 7 . Food and Drug Administration'3 Proponed Interim Food - Additive Regulation on PVC is published. In the meantime, v:a shall continue to keen in as close contact as possible with Food and Drug and will report to you fully as matters proceed. Enclosure ucc 029626