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Z90S LOOOdV ^ "e*r INTEROFFICE MEMORANDUM To From Richard Fleming W> Mavo Smith cc: A. Rossp^ftfiams dir L. Mi J. T. BaVr T. L. CareV/H. L. Watson Subject Date 12 June 1975 MCA - VCM__________________ Valley Forge____________ (Location, Organization, or Department) T-Town___________________ (Location, Organization, or OeparimentJ E. Donley J, V. Helder G. J. Mantel1 Dr. M. Kuschner (via ARA) This Is the reply to Science (see memo WMSmith to Richard Fleming, 23 May 1975, MCA Meeting -22 May 1975) which four of us prepared to go over AT Clark's signature (MCA) during our meeting. wribtcmw U). m Js?ufJ ; Q/yiuAJj (320) i AP00015063 ALBERT C. CLARK VICE PRESIDENT TECHNICAL DIRECTOR MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE, N.W. WASHINGTON, 0. C. 20009 {202) 483-6126 June 2, 1975 Philip H. Abelson, Editor "Science" 1515 Massachusetts Avenue, N. W. Washington, D.C. 20005 ' V% Dear Dr,.Abelson: The Edsall article, "Scientific Freedom and Responsibility" (J. T. Edsall, "Science," May 16, 1975) requires comment. X presume Dr. Edsall is not responsible for the content of the arti cle, but merely prepared it from the AAAS committee report. How ever, scientific freedom and responsibility are as important for AAAS committees as they are for other scientists. The "case of data suppression concerning the carcinogenicity of vinyl chloride" (pg. 690) is a melange of omissions and untruths inconsistent with scientific freedom and rcspoiisil/iliL^. Sihl-b so much pertinent information has been omitted concerning this matter readers may be misled into believing Dr. Edsall's report. Edsall states that, "up to that time (May 1970) there had apparently been no research in the plastics industry concerning the possible hazards of vinyl chloride...". This is untrue. In fact, the basic published data on vinyl chloride toxicity came from American industry.(references 1-7) The information in refer ences 4, 5, 6, and 7 had been publicly disclosed and presented prior to their publication dates. Furthermore, the investigations of Dr. P. L. Viola and Dr. Maltoni have been supported by European industries. Edsall correctly states that Manufacturing Chemists Association (MCA) member companies entered into an agreement with the European sponsors of Maltoni's work not to reveal preliminary Italian data. The agreement was not dissimilar to that between American sponsors (Government, Industry, and Academic) and research institutions that new data remain the property of the institution and not be disclosed until the study is completed and evaluated prior to disclosure of final results in proper scientific channels. There was no intention to withhold adverse data. Under MCA rules, all data developed under its auspices must be promptly reported publicly. Without exception, this has been done with all data on vinyl chloride. AP00015064 Philip H. Abelson, Editor "Science" June 2, 1975 page 2 U. S. Government scientists knew of Maltoni's preliminary results early in 1973 but considered it as preliminary as did U. S. industry. At the Second International Symposium on Cancer Detection and Prevention in Bologna# April 9-12# 1973, Dr. Maltoni showed a table of preliminary results linking vinyl chloride with cancer formation8 (not published until 1974). Dr. Umberto Saffiotti, Associate Director of Carcinogenisis, National Cancer Institute# was present at the meeting and subsequently discussed the results with Maltoni at his Italian laboratory.9 Saffiotti felt that the work needed to be included in "a well documented report" to be assessed by the World Health Organization (Review Panel of the International Agency for Research on cancer of which the United States is a mem ber) . This committee also considered Maltoni's data preliminary at that time and "decided to postpone compilation of the definitive review to the next meeting of the committee."9 Following a period in which epidemiological and animal studies were being established, MCA on April 17, 1973 asked the Europeans to jointly make presentations to United States and European Govern ment authorities. The Europeans readily agreed, and on June 15, 1973 MCA called the National Institute ror uccupauional Sttfeuy emu HwalLh (NIOSH) and requested an opportunity to bring new information to that agency's attention. The appointment was set by NIOSH for July 17. Five European and American industry representatives presented to NIOSH the information that tumors had been observed at concentra tions below that reported by Viola. At that time, human cases had not been reported? therefore, no special significance could be attached to the types of tumors observed by Maltoni. The MCA suggested label referred to by Edsall was illustrated in the Chemical Safety Data Sheet (SD56) on vinyl chloride, revised April 1972. Section 10.1 on Health Hazards refers to Viola's pub lished studies. The Data Sheet states "Recent research studies reported from Italy indicate that repeated, long-term high level exposures of rats to vinyl chloride monomer vapor can result in the development of malignant tumois. However, many years of in dustrial experience with human exposures to concentrations frequently far above current standards have not demonstrated any carcinogenicity to humans." Thus the statement by Edsall that MCA "...appears to have deliberately deceived NIOSH regarding the true facts." is inac curate and misleading. Sincerely, AP00015065 References: (1) Torkelson, T. R., F. Oyen, and V. K. Rowe. The toxicity of vinyl chloride as determined by repeated exposure of laboratory animals. American Industrial Hygiene Association Journal, 22(5} . 354-361. 1901. (2) Wilson, R. II., W. E. McCormick, C. F-. Tatum, and J. L. Creech. Occupational Acroosteolysis, report of 31 cases. The Journal of the American Medical Association, 201(B), 577-581. 1967. (3) Baretta, E. D,,, R. D. Stewart, and J. E. Mutchler. Monitoring Exposure to vinyl chloride vapor: breath analysis and continuous air sampling. American Industrial Hygiene Association Journal, 30, 537-544. 1969. (4) Dinman, B. D., W. A. Cook, W. M. Whitehouse, H. J. Magnuson, and T. Ditcheck. Occupational Acroosteolysis: X. An Epidemio logical Study. Archives of Environmental Health, 22, 61-73. 1971. (5) Cook, W. A., P. M. Giever, B. D. Dinman, and H. J. Magnuson. Occupational Acroosteolysis: II. An Industrial Hygiene Study. Archives of Er.viioaii'ueiiLeil Health, zr, /4 --82. 1971. (6) Dodson, V. N., B. D. Dinman, W. M. Whitehouse, A. N. M. Nasr, and H. J. Magnuson. Occupational Acroosteolysis: III. A.clinical study. Archives of Environmental Health, 22, 83-91. 1971. (7) Kramer, C. G., and J. E. Mutchler. The correlation of clinical and environment measurements for workers exposed to vinyl chloride. American Industrial Hygiene Association Journal, 33(1). 19-30. 1972. (8) Maltoni, c. Occupational Carcinogenisis. Proceedings of the Second International Symposium on Cancer Detection and Prevention. Bologna, April' 9-12, 1973. Excerpta Medica, Amsterdam. 1974. (9) Hearing before the Subcommittee on Environment of the Committee on Commerce, United States Senate,1, August 21, 1974, (Serial No. 93-110) on Dangers of Vinyl Chloride, pages 54-56. APOOO15066