Document XR2mGBzggOZ3JmDGwjd1baN74

i Attached is my report on the MCA vinyl chloride conference held in Washington, D. C., November 16, 1971. Mark Anthony also attended this conference and has written a separate memo-- randum. My report is quite detailed but the following points .should be considered in evaluating the carcinogenic potential of vinyl chloride: 1) In the' study reported, a massive concentration of VCM was exposed to only one species of animals and to one sex. 2) The animals were exposed under extremely severe con ditions which not, only involved the inhalation route of exposure but dermal and oral routes of exposure, 3) There is a serious question as to the impurities in the VCM used in the Italian experiment. 4) The Italian investigator has stated that he feels there is not a human health problem related to the manufacture of VCM or the use of VCM in PVC plants. 5} . Is the human health problem relative to the manufacture of VCM and its use in PVC plants one of an acute nature or a truly chronic problem? 6) Should the industry support a study in a deliberate at tempt to repeat an experiment which is unrealistic in terms of human exposure? SAFEGUARD COMPANY INFORMATION R&S158796 E. C. Galloway ; Page 2 11/23/71 r I have stated these points not with the idea of being the "devils advocate" but with the hope that a sound technical approach can' be made to this problem. Chemical carcinogenesis is not a totally unknown quantity. I obtained the definite impression at ` this conference that many in attendance questioned the validity of the approach taken by the MCA Occupational Health Committee. My recommendation is that if an animal study is to be sponsored by industry, it should be conducted at maximum levels at which a plant worker could be exposed and at lower levels that would delineate a dose response and no effect level. My reasoning is that Viola should clarify the report he has published relative to dose response and no effects - the industry should study VCM at the levels at which a worker may obtain a chronic exposure. I disagree-with the recommendation that we must design an ex periment to refute the published work and prove the negative. It is extremely difficult to refute published literature per se. Industry's responsibility is to prese'nt factual evidence that VCM can be manufactured and used in PVC plants safely. ch Attachment A. B. Lindquist R&S158797 Runcorn Cheshire WA7 4QF Teleohone Runcorn (0928 5) 73456 Telex 62655 Icimoncnq fiuncn Telegrams Icimondiv Runcorn Manufacturing Chemists Association 1625 Connecticut Avenue LTW Washington DC 20009 USA F?r the attention of Mr G E Best Chemical Industries Limited Mond Division Your ref Our ref dme/fd Tel ext Date 30 Oct 72 Dear Mr Best As you will know, a programme of experimental work aimed at investigating the possible biological properties of vinyl chloride monomer is already being undertaken in Europe, sponsored by a Group of European VCM/pVC manufacturers (the European Group). In the United States, a group of VCM/PVC manufacturers, under the auspices of the Manufacturing Chemists Association (MCA) is also considering the establish ment of a programme of experimental work in the same field. It has been agreed that benefits to both sides should be achieved if there is co-ordination between the programmes so as to make the results mutually supportive as far as possible. It has also been agreed that it is necessary to safeguard the confidentiality of the information arising from the two programmes. Against this background the European Group agreed to collaborate with the MCA and disclose the experimental protocol and, at an appropriate time, the results on the following conditions: a) That the companies sponsoring the European work will be represented in both the MCA VCM Research Sponsorship Group and in the project's Technical Co ordinating Task Group. b) No disclosure of information arising from the European investigation will be made outside the Companies comprising the MCA VCM Research Sponsorship Group without the specific consent of the European Group. At the same time, the members of the European Group would accept the restriction on communication of the MCA results as originally expressed in the draft research programme dated 27th January 1972. c) No financial contribution will be required from members of the European Grout who shall have equal status to other contributing sponsors in respect to access to project information on a current basis and participation in sharing ideas and suggestions. R&S158798 * From: To; ICI Mond Division Runcorn Manufacturing Chemists Association Washington DC Continuation Sheet No Date 30 Oct ~J2 If the above conditions are accepted by the MCA and the Companies sponsoring the MCA VCM Research Programme, would you please indicate this by countersigning the duplicate copy of this letter which is enclosed and returning it to me. Accepted for and on behalf of Manufacturing Chemists Association and all the Companies sponsoring the MCA Vinyl Chloride Monomer Research Programme General Manager - Production Solvents and Monomers Group R&S158799 f- Aniroal Testing Research - Vinyl Chloride Monomer With regard to any information disclosed to personnel of our company concerning the European research on vinyl chloride monomer referred to in R. I. Lindsell's letter of August 16, 1972, addressed to the Manufacturing Chemists Asso ciation, we pledge to hold such information strictly in confidence within our company unless and until formally notified specific consent to its release has been granted by the European sponsors. Please return one copy promptly to: George E. Best - Manufacturing Chemists Association 1825 Connecticut Avenue, N. W. Washington, D. C. 20009 R&S158800