Document 5kq3Oq7nV4zYKXJ7D8K7oLyR8

JOSEPH K. KEI.I.KIt JEROME 11 HECKMAN cuaui.es m xkkhan VILLIAM 11 1IOHOIII.SANT..IK HOUEUT If TIL UN AN VAYKE V. ULACK DAVID L. MILL MANTIS* V. DLWCOV1C1 PETEK M- KEMKOV Joseph e. uadley carole c. Harris RETEU THOMAS SMITH MICHAEL V. MORHONE LAHRT S. SOLOMON* TO: Law orrici:s AND IIK OK MAX HDD ITTM NTHHin, K. v. SUITE lOOO WASHINGTON, D. C. COOSO March 25, 1976 TKUI'Honm: Cf03 y'Xi-LVUO CAlll.E ADUUI-SN "KI'.IMaV receiv fo No. 18 'QTfi P.J. Jos^hans All Members of PVCA'CM Mailing Lists Ladies and Gentlemen: During the past week there have been some devel opments of interest regarding the vinyl chloride and polyvinyl chloride situation, primarily as regards thepending Food and Drug Administration (FDA) rulemaking proceeding. As a result of informal conferences at the Food and Drug Administration, we should perhaps first advise that FDA is still indicating a target date of "the end of the next quarter" for action of some type. Nevertheless, our feeling is that the target date is not particularly firm since a number of what might best be characterized as internal philosophical differences will require resolution. In the following paragraphs, our objective will be to bring you up to date once more to the fullest ex tent possible on the FDA status; as far as the Environ mental Protection Agency and the Occupational Safety and Health Administration are concerned, we have no additional hard intelligence to convey. Late last week Ralph Harding and others in this country were contacted and advised that Dr. John Stafford, who has replaced Dr. Barry Earnes, as Chairman of the CEFIC (European Council of Chemical Manufacturers' Federations) Committee for the Toxicity of Vinyl Chloride would be visiting in this country to tell a number of us about the activities taking place overseas. Rather than burden you with an attempt at summarizing the most worthwhile con versations we, Ralph, and others have had with Dr. Stafford, BOR 008809 March 25, 1976 Page Two we are simply enclosing herewith the following docu ments which we believe wil serve to provide you with a "bottom line" on what has taken place: 1. A copy of a generally excellent report prepared by the CEFIC Committee. Despite the covering letter from Mr. Garnett to Mr. Harding with respect to the report, we think it is fair to say that it may now be considered generally available information since the document has been given to the appropriate parties in foreign governments, and we have now transmitted a copy to the Food and Drug Administration. 2. A copy of a letter Ralph Harding has sent to Dr. Louis B. Thomas of the National Institute of Health, National Cancer Institute, strongly urging Dr. Thomas to consider a visit with Dr. Maltoni to obtain the very latest word on the Maltoni toxicology studies. You will note that a copy of Ralph's letter was also sent to Mr. Richard Ronk at the Food and Drug Administration. Informa tion copies will likewise be transmitted to the National Institute of Occupational Safety and Health, and perhaps others. 3. Finally, there is enclosed a copy of a letter we directed to Dick Ronk of the Food and Drug Administration yester day. As you will see, this letter was employed to transmit the CEFIC report and directed attention to the part thereof which indicates that Dr. Maltoni has thus far seen no liver angiosarcomas at the 3.3 mg/kg dose level. It was necessary for us to indicate in the letter to Mr. Ronk that we differ with some of the discussion BOR 008810 March 25, 1976 Page Three in the CEFIC work, particularly to the extent that it urges the setting of what would amount to finite "tolerances" for VCM migration. Our European contacts understand that v/e cannot support that position here since this could bring the Delaney Clause into play in a way that we have consistently sought to avoid. Aside from this activity, v/e have also been in close touch with the National- Sanitation Foundation and our contacts at FDA on the PVC pipe situation. It re mains in a state of flux so that we have nothing we care to report at this time. We do want you to know that we are working on a strategy which we hope will bear signi ficant fruit but this is all we are in a position to say at the present time. ** As far as we are aware, the Environmental Pro tection Agency still plans to take action on its pro posed standard by the end of June, although earlier action is possible. With respect to CSKA, we do understand that still more companies have applied for variances with the April 1 effective date almost upon us; should v/e obtain additional information in this respect, or with regard to, somewhat vague "stirrings" on other enforcement ques tions at OSHA, we will report to you appropriately. Cordially yours, Enclosures BOR 008811 COPY COPY March 24, 1976 Dr. Louis B. Thomas Chief, Pathological Anatomy Department Clinical Center National Institute of Health Bethesda, Maryland 20014 Dear Dr. Thomas: I have been told that Professor Cesare Maltoni has informally and orally given further interim findings on his on-going vinyl chloride animal studies to a group of French cancer specialists in early March. Therefore, I would like to recommend that you make contact directly with Professor Maltoni so that we may have the benefit of your analysis of these data. This letter is addressed to you because of your central role in this matter, and so that the work of your group can be properly extended to include any new data that he makes available to you. It is my best judgment that this contact should be made through a personal visit to Bologna. During Professor Maltoni's last visit to the United States he indicated on a number of occasions that he did not want to make any more public or written statements on an interim basis. Indeed, he felt it best to complete his studies and then publish a final report before returning to the United States. However, I believe that if you and other qualified pathologists were to call on him, he would share his most current observations with you. A CEFIC report*which we are today giving to the Food and Drug Administration contains some interim observations from Maltoni studies that are more current than anything previously published. Finally, the Vinyl Chloride and Polyvinyl Chloride Producers Group, which I represent, would prefer that the data be given directly by Professor Maltoni to you. Experience has shown that much more is accomplished when this type of sophisticated program is discussed directly by those who are fully qualified to determine its significance. If you wish, I will be pleased to help you with appropriate arrangements. Cordially, RLH:lj CC: Professor Cesare Maltoni Richard Ronk BOR 008812 *"Vinyl Chloride Toxicity & the Use of PVC for Packaging Foodstuffs" prepared by the European Council of Chemical Manufacturer';' Federations (CKFiC) JOSEPH E. KELLER ilElt ME U. HECKMAN CHARLES M. MEEHAN' WILLIAM II. MORGUESAN'I.JK. KOUERT H. TIERSAN WAVNU V. BLACK AVJJ> L. HILL MARTIN w. BEBCOV1CJ PETEK M.KKMXOV JOSEPH E. IIABLET CAROLE C. HARRIS PETER THOMAS SMITH MICHAEL F. MOM RONE LARRY S. SOLOMON LAW orrtCKS Kellei? and Heckman itso itTM sthi:i:t# n. w. SUITE IOOO VASHINOTON, I>. C. OO30> March 24, 1976 TtUlllOST *02 200'UlOO CADLE AJlUKr.NK "KRtMAN" Mr. Richard J. Ronk Director, Division of Food and Color Additives Room 5825, HFF-330 Food and Drug Administration 200 "C Street, S. W. Washington, D. C. 20204 Re: Docket No. 75 N-0190--Vinyl Chloride Polymers in Contact With Food; Notice of Proposed Rulemaking, 40 Fed. Reg. 40529, September 3, 1975. Dear Mr. Ronk: In connection with the above-referenced proposed rulemaking, the purpose of this letter is to provide the Food and Drug Administration with relevant additional information which has just been received by us. Thus, enclosed herewith are three copies of a publication entitled "Vinyl Chloride Toxicity and the Use of PVC for Packaging Foodstuffs." The document was prepared by the European Council of Chemical Manufacturers' Federations (CEFIC) Committee for the Toxicity of Vinyl Chloride. Also enclosed are three copies of a letter just directed to Dr. Louis B. Thomas of the National Cancer Institute by Ralph L. Harding, Jr., President of The Society of the Plastics Industry, Inc. As you will see, this letter indicates that Professor Cesare Maltoni reported further interim findings vis-a-vis his ongoing vinyl chloride animal studies to a group of French cancer specialists early in March. BOR 008813 Mr. Richard J. Ronk March 24, 1976 Page Two With respect to the CEFIC publication/ al though it is marked "confidential/" we have been authorized to transmit copies to the Food and Drug Administration by a CEFIC representative who has given us permission to reproduce and distribute the document. Of particular interest to us, and we suspect perhaps to FDA, is Table 3 which appears in Appendix 3 of the report. This table summarizes Professor Maltoni-'s ingestion data 84 weeks into his experiment. We/ therefore/ believe the data is more up to date than that previously made available in any formal way. We are particularly pleased to have noted that, at the 3.3 mg/kg dose level/ no liver angiosarcomas have been seen as of this date. In submitting the CEFIC report, we do wish to emphasize that SPI in no way endorses all of the philosophical or legal concepts and principles presented therein; indeed, we continue to hold to the position that the Delaney clause is wholly inapplicable to the polyvinyl chloride packaging problem in light of the current state of the art in this country. However, we believe that the CEFIC discussion about the assessments of risk associated with low level exposures to vinyl chloride are sound, and provide strong additional support for the position advanced by SPI in its Comments, i.e. that a determination that there is no reasonable expect ation of migration of vinyl chloride to food by means of a suitable analytical procedure assures that there will be no risk of harm when such packaging is used. With respect to the information we have heard regarding Professor Maltoni's informal oral reports, you will note that Mr. Harding's letter to Dr. Thomas urges that he consider visiting with Professor Maltoni with a view towards obtaining details from him about the precise status of his activity. It might well be that the Food and Drug Administration should also consider contacting Professor Maltoni to obtain the benefit of the best available toxicological data to guide its deliberations. BOR 008814 Mr. Richard J. Ronk March 24, 1976 Page Three We trust that you will find the information we are providing useful. If there is anything you feel we can do to help arrange for more direct contact be tween the Food and Drug Administration and appropriate parties overseas, we will be glad to do so. In the meantime, we will continue to transmit to you any ad ditional information we receive. Cordially yours. Enclosures BOR 008815 CEFIC SQUARE MARIE.LOUISE 49 10*0 BRUXELLES Til.: 02/735.40.80 TtliX: FECHIM B 23.167 R : ASG/TB/306a CONSEIL EUROPEEN DES FEDERATIONS DE L1NDUSTRIE CHIMIQUE EUROPEAN COUNCIL OF CHEMICAL MANUFACTURERS'FEDERATIONS 16th March 1976 Bruttlta, !'. Mr. Ralph L. Harding, Jr. SOCIETY OF THE PLASTICS INDUSTRY INC. Park Avenue 250 New York, New York 10017 U. S. A. Dear Mr. Harding, I have pleasure in enclosing copies of a book that we.have prepared entitled "Vinyl Chloride Toxicity and the Use of PVC for Packaging Foodstuffs". The book is almost entirely the work of Barry Barnes. It is intended to bring together all the facts concerning the use of poly vinyl chloride food packages and to make an assessment of the risk factors and thus provoke, what we hope will be useful, discussions lead ing to a better understanding of all the factors involved. The book has been distributed quite widely in Europe to government authorities, research centres and within indu stry. It has not been released to the press. In view of the fact that national governments and the Euro pean Commission have copies we would have no objections if you wish to discuss the document with the FDA or any other branch of the US government. As a matter of interest we would like to know if this document is shown to a govern ment department what protection from further publication copyright affords us. Yours sincerely cc: Mr. Heckman A.s. Garnett BOR 008816