Document 8ORB5OG1ZJ9Yd29p4dm116Xne

CO JOSKPn IS. KELLER JEROME n. HECKMAN CHARLES M. MEEHAN william H. DORGIIKSANI, jii ROBERT R TIKRNAN WAYNE V llLA^ DAVID L, HILL MARTIN W. DLRCOVICI EDWIN 13 5PIEVACK PETER M NEMKOV JOSEPH E HADLEY CAROLE C HARRIS WILLIAM W PUGH I.AW OFHCh ' Keller and Heckman 1150 17T" STHlCLT, N. W. SUITE 1000 "Washington, d. g. 200:30 March 18, 1974 *& TlSLKMlOSK aoa oo C'ADLE AULRI'hS "KLLM\N"' TO: All Members of: SPI Food, Drug and Cosmetic Packaging Materials Committee; General Polyvinyl Chloride Interest Mailing List V; Ad Hoc Liquor Bottle Committee; Plastic Pipe Institute (Executive Board); Plastic Bottle Division (Voting Representatives); SPI Executive Committee; SPI Public Affairs Committee RE: Prior Sanctioned PVC Status; Proposed Rule Making Gentlemen: Following up on our letter of March 12 which, I am sure you all know, has lead to great concern among everyone interested in the polyvinyl chloride problem as it has developed at the Food and Drug Administration, and also to our being virtually swamped with telephone calls for further information, the purpose of this letter is to try to keep all interested parties as up to date as possible. In so doing, we are following the explicit instructions' of the President of SPI, Ralph Harding, who, like we, is hopeful that our posting you as responsibly V We are substituting this designation for the one here tofore used on correspondence of this type because, ob viously, the PVC problem has transcended the original interest which was centered on liquor bottles and the Bureau of Alcohol, Tobacco and Firearms. Continuing to use the misnomer "BATF Mailing List" is no longer really appropriate and no harm would seem to be caused by changing the designation since the mailing list did not constitute an official SPI group. ASI-PR 0002140 March 18, 1974 Page Two as we can will calm some unnecessary fears and delimit much of the rumoring and erroneous hearsay being generated by the telephone contacts. This process might also sug gest to many of you the desirability of avoiding the telephoning of the Food and Drug Administration's Staff since we doubt that this will be helpful to you or FDA in the effort being made to maintain perspective on the case. Turning more specifically to the problem, firstly we are enclosing herewith, with the permission of the. editors, reproductions of pages 23 and 24 from this week's edition of Food Chemical News. As many of you know, but some may not, Food Chemical News is the basic reference publication for Food and Drug Administration developments in the food additives and other related areas. This will probably explain to you why the report is, in our opinion, quite objective and as reasonably low-key as may be expected from a responsible publication under the circumstances. The point here is that "the un official word is out" although official action has not yet been taken. Today we spoke at some length with Dick Ronk of the Division of Food and Color Additives who, as you know from our previous letters, is pretty much heading up the FDA activity on PVC at this time. We were advised that work is going forward on a draft Order which will propose removal of the "prior-sanction" on PVC and propose re placing the prior-sanction with an Interim Food Additive Regulation along the lines described in our last letter. The thinking at FDA has not progressed to the point where we can be any more definitive than this except that we can tell you we have been asked to stand by to help with the drafting activity, especially as it might relate to including proposed test methodology for the Interim Food Additive Regulation. Wc might also note that there is an outside possibility that FDA will invoke emergency powers to make the Order effective immediately, instead of simply proposing the action and receiving com ments before moving. We say this is an outside possibility ASI-PR 0002141 March 18, 1974 Page Three because Mr. Ronk informed us that the more likely approach will be to propose, receive comments, and then take action in promulgating an Interim Food Additive Regulation. During the course of this process, please understand that the prior-sanctionwill remain in~ effect so as to leave the marketplace in tact, at least'legally and scientifically. As far as timing is concerned, Gerad Mccowin of Mr. Ronk's Staff is working on the project. Mr. Ronk advises that he is unlikely to have even a first draft for internal consideration before the end of this week. The matter would then have to be considered at a number of levels in FDA so the prediction at the moment is that nothing definite is likely to appear in the Federal Register in less than three or four weeks. Again, please understand that the prior-sanction remains in effect during this time. Moreover, there' isno vaTidTYeasbn for those m such industries as the plastic pipe industry, or the supplying of cosmetic containers, to be unduly con cerned. There is every likelihood that the present use of PVC in these areas will not be affected, at least until such time as toxicological work is completed, the anticipation being that this might require as much as two or three years. Furthermore, many of those knowledgeable abou',: the toxicological situation have given us reason to believe that appropriately conducted studies might well lead to a satisfactory conclusion of the toxicology issue. The one circumstance which might have to change more rapidly is that, if FDA adopts an Order limiting residual monomer in food contact surfaces, the type or quality of PVC compound used for all applications may have to be changed to take this into account, i.e. com pounds with lower residual monomer may have to be employed by those using them for food containers, film, potable water pipe, etc. As far as any meetings or other follow-up activity are concerned, discussions have been taking place but it has been generally agreed that no useful purpose would be served by calling sessions until such time as the Food and Drug Administration does issue something definitive. You ASI-PR 0002142 March 18, 1974 Page Four have already been alerted to the fact that a meeting might need to be called on short notice. In the meantime, we will simply try to keep you fully briefed by letters such as this one. Enclosure ASI-PR 0002143