Document N2r9EBroQxeyNRwQ1pxBvy8Q8

JuSEPlI E KE 1 LEW JEROME H IITCK'US' rilARI.ES M MEEHA> WILLIAM H PORCHFSAM HODEHT H Tl EH v.\S W.OXE V BLACK DAVID l hill MARTIN' W BERCOVICI PETER M VEMKOV JOSEPH E HADLEY. JR cCarole Harris PETER THOMAS SMITH MICHAEL F MORRONE LaRRT S SOLOMON >R law orrtc-ES Keller and Heckman USO IP'S STREET, N V.S L'tTE lOOO Washington, d.c. 2003G October 26, 1976 TELEPHONE 303 4S7 - UOO cable address "keimax WRITERS DIRECT DIAL NLMBER 457-1110 TO: All Members of SPI-PVC/VCM Mailing List Letter Highlights 1. Latest information from FDA suggests that no final PVC Regulation can be expected before the end of 1976 at the earliest. 2. The new EPA emissions standards pose major economic burdens; but there are few tech nological shocks. Ladies and Gentlemen The primary purpose of this letter is to bring you up to date on our latest information regarding the timing of the Food and Drug Administration's (FDA) final regulations on polyvinyl chloride. Secondarily, it will confirm the Environmental Protection Agency's (EPA) promul gation of its regulations governing vinyl chloride emissions, regulations which affect only manufacturers of vinyl chlo ride monomer, polyvinyl resin per se, and certain related products. FDA As many of you may already know, FDA's Bureau of Foods, the branch of the Administration responsible for the promulgation of the polyvinyl chloride Food Addi tive Regulations, is involved in a rather major reorganiza tion and a redefinition of long range goals. In addition, SPI-24373 October 26, 1976 Page Two the Division of Food and Color Additives, the division with specific responsibility for the PVC regulation, is also facing a move from its current location at 200 C Street, S.W. to the Donahue Building on 6th and D Streets, S.W. As a result of pressures on the staff to complete planning in both of those connections, our latest infor mation is that it is unlikely that any final polyvinyl chloride regulations will be promulgated this year; if such regulations appear at all, there seems to be no possibility that they will be promulgated before the very end of December. To the best of our knowledge, concerned personnel at FDA now have a major portion of their time allocated to the development of long term plans for implementing FDA's projected overall additives safety review. This will involve the addition of perhaps 75 new people to work in the Division of Food and Color Additives where only ten are now employed in a comparable capacity. The program is intended ultimately to provide a review of the safety of all presently regulated direct and indirect additives in light of present standards. It will sup plement the GRAS and prior sanction reviews now well under way. In addition, the move to the new quarters is also demanding planning attention and has resulted in initial packing of records and the like. These two factors, combined with the need to prepare for Hearings on Color Additives have meant (we gather) that the polyvinyl chloride Regulations have received almost no attention and are not likely to receive any significant amount of attention, at least until the move has been accomplished. Since the move was originally scheduled for the end of October, then the end of November, then the end of December and now the end of November again, perhaps this will help you understand the basis for our "guesstimate" as to timing on "final" PVC regu lations. As to the substance of the Regulations, there is nothing that we can add to our past reports because so little attention has been given to this at FDA Staff level. Nevertheless, we are continuing to maintain close SPI-24374 October 26, 1976 Page Thre-e contact with the Staff in the event that any presently unanticipated activity develops. epa With respect to the Environmental Protection Agency's new standards on vinyl chloride emissions, the Regulations contained no real shocks. This is not sur prising in light of the procedures used by EPA which include consulting with and informing all interested parties concerning the substance of drafts of the Regu lations. This helps to insure that the ultimate Regu lations are as feasible as possible and are based upon up-to-date knowledge of the industry. Despite the fact that the regulation will impose serious economic burdens on the VC/PVC industry, the requirements seem to be within the realm of known tech nology and are in most respects believed to be attainable. In most of those areas where the goals have not already been reached, it is anticipated that they will be achieved within the time period allowed. We report this for general interest mainly, because those who are directly affected by the Regulations are well aware of the detailed require ments and implications. ** Once again we want to assure you that we will follow the various aspects of interest to the vinyl chlo ride/polyvinyl chloride industry as closely as we can and will continue to report to you promptly. Cordially yours, / SP1-24375 ERRATUM This letter should be identified as No. 29 not No. 28. SPI-24376