Document zd77XK4n3GVj3yz2ok8k4jx86

MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE. N.W. WASHINGTON, D. C. 20009 (202) 483-6126 received `CT < 1974 MEDICAL DEPARTMENT September 27, 1974 To: Technical Task Group on Vinyl Chloride Research Subject: Conference with Rail Committee re Vinyl Chloride Research Gentlemen: Distributed herewith are copies of Dr. V. K. Rowe's notes on the subject conference. MCA has, by telephone, ex pressed to Dr. Wands its support of the coordination center proposal, and of its willingness to cooperate in its activi ties. Sincerely KDj/mb Enclosure cc: Mr. A. W. Barnes D. F. Duffield, M.D. Dr. Tiziano Garlanda Kenneth D. Johnson, Ph.D. Secretary Technical Task Group on Vinyl Chloride Research MEMORANDUM TO See Below DEPARTMENT OF HEALTH, EDUCATION, AND WFI. FaR.i- PURtlC HEALTH SERVICE NATIONAL INSTITUTE* Of HEALTH National Institute of Environmental Health Sciences date: September 5, 1974 from : Director, NIEHS subject: Vinyl Chloride Meeting of August 14, 1974 Enclosed are the notes which V. K. Rowe took at our Vinyl Chloride meeting in Washington, D. C. on August 14, 1974. I discussed the concept of setting up an NAS-NRC clearing house effort in Vinyl Chloride with the HEW Toxicology Coordinating Committee. The Committee endorsed this concept. Next day Drs. Shapiro and Plumle contacted Dr. Ralph Wands informally and he seemed agreeable. It appears, therefore, that the next step is for me to write Dr. Handler with a formal request, which I shall do. Addressees: Dr. Nancy Beech Dr. A. Pallottta Dr. L. Plumlee Dr. R. Shapiro H. Kusnetz Dr. N. Littlefield Dr. E. Fairchild Dr. M. Mehlman Dr. I. Mitchell David P. Rail, M.D.,, Ph.D. URL 17643 VINYL CHLORIDE MONOMER--NOTES FROM AN AD HOC MEETING CONCERNED WITH RESEARCH PROGRAM COORDINATION The meeting was held August 14, 1974, in the Potomac of the Marriott Twin Bridges Motel, Washington, D.C. purpose of the meeting was to discuss means by which groups interested in toxicological research on vinyl monomer (VCM) could develop a coordinated program. Room The various chloride Attendees: EPA Dr. Nancy Beech Dr. A. Pallottta Dr. L. Plumlee NCTR Dr. M. Littlefield NIEHS FDA Dr. R. Shapiro MCA Mr. H. Kusnetz (Vinyl Chloride Tox. Committee member) Dr. David Rail NIOSH Dr. E. Fairchild The Dow Chemical Company Dr. V. K. Rowe URL 17644 The meeting was called to order at 3:10 PM by V. K. Rowe on behalf of Chairman Rail who had asked that we proceed as he would be a bit late. Dr. Pallotta, who had just returned from Europe where he had visited Dr. Maltoni*s laboratory, reported that this laboratory was superb. He said that he had not seen a finer laboratory anywhere and that the conduct of the experiments in progress and the records being kept were above reproach. Dr. Pallotta*s judgment was based upon seeing but one of Dr. Maltoni's four operating laboratories. He indicated that a new laboratory is being built inside of an old palace which the Italian Government apparently had given to Dr. Maltoni for his work. Dr. Pallotta indicated that Dr. Maltoni has observed an angiosarcoma of the liver in one of the hamsters exposed to 500 ppm VC1? is conducting URL 17645 2- - an experiment in which old animals are being exposed to VCM; and he is studying another monomer# the identity of which was not disclosed. Dr. Shapiro stated that he was certain that oral studies involving the administration of VCM in olive oil were being conducted at Dr. Malton's laboratory and also at laboratories in the Netherlands and England. He wasn't positive that all of these experiments were underway# but if not# they were to be started soon. Rowe was asked to outline the purpose of the meeting. He stated that the VCM problem is huge, involving many agencies of government, industries# and universities and its scope is worldwide. He feels that research is likely to continue to . go in all directions because there is no one central informa tion center. It seems reasonable to anticipate that agencies, particularly funding agencies# will be beseiged with requests for grants for contracts to do toxicological work of one kind or another on VCM. The agenices have no way# at the present time# of knowing whether such work is already being done. The same situation applies to industrial research laboratories and industrial groups seeking to sponsor studies at outside laboratories. Rowe believes that there is a need for coordina tion of research which is being conducted on such a large scale in many places within and outside of the U.S.A. Such a coordinating office might well be set-up to collect protocols from various investigators# release data as soon as it is ready #and to keep track of intentions of various groups of researchers. It would then be possible for anyone planning to do research on VCM to find out what was being done# where it was being done and by whom. Such a center would most certainly not have any power of direction, but would provide a forum whereby it would be possible for a group to not URL 17646 -3- unwittingly duplicate research which was complete or under way. Furthermore, it would permit researchers to inquire and discuss the programs in progress prior to starting programs of their own. Programs could then be designed to duplicate/ for purposes of confirmation or to complement studies underway. Rowe believes this is the only way in which we can avoid wastefulness. Consequently,such a clearing house should enhance the acquisition of knowledge so badly needed. It was also pointed out that such a clearing house could assume the leadership in calling conferences of interested researchers and thereby assist in the dissemination of information. There seemed to be no opposition to the program and, in fact,;, there was unanimous agreement that such a coordination center' should be developed. The discussion began about how and where the objectives could be accomplished. Dr. Plumlee stated that there was precedent for such a clearing house. He stated that the late Dr. Leo Friedman of FDA and Dr. Ned Byerly of USDA had set-up a similar group concerned with the nitrosamines. He felt that this particular group had been very effective in enhancing com munications between researchers concerned with the problem. Dr. Lassiter thought that perhaps one of thj e groups under the ILO could be used, Mr. Kusnetz thought that there might be possibilities within the EEC. Dr. Plumlee mentioned that the NCI could probably help and Dr. Pallotta emphatically agreed. Dr. Lassiter also mentioned that the International Agency for Research on Cancer ( IARC ) hearquartered at Lyon, France might also serve since they are already collecting and coordinating worldwide efforts on cancer research. URL 17647 -4- Dr. Pallotta suggested that perhaps Ralph Wands, Advisory Center on Toxicology in the NAS/NRC could effectively do the job. Dr. Shapiro pointed out that Mr. Wands' office would have the means of interfacing with the Europeans and others as well as coordinating any work in the U.S.A. Dr. Rail reported that Dr. Brant Dietrich, Head of Environmental and Occupational Health of WHO might also be willing to help. The suggestion that Ralph Wands* office be the coordinating office received unanimous support. A recess was called and Dr. Shapiro called Ralph Wands to see i it would be feasible for his office to undertake such a coordinating job. Wands indicated that he would be willing, that there was no question of feasibility and that the agencies or groups involved would have to having a working contract with NAS/NRC. He mentioned-, that funding would be required and details of this could be worked out. This proposal seemed to meet with the approval of the entire group assembled. The next question considered was what agency or groups should be asked to sponsor the contract with the NAS/NRC? Several possibilities were mentioned, the ONR which already has a big contract with the Academy, the NSF, EPA, FDA, NIEHS, OSHA, and DOL were also mentioned as possibilities. It was agreed, however, that a group or agency having little or no political interest in the VCM problem would probably "be the best, for it would provide an umbrella under which all of the interested parties could work together. Dr. Fairchild noted that any single agency could go directly to the NAS/NRC and industry could do likewise. However, it seemed to be the consensus that it would be better if they could go "piggy-back" on an existing contract such as that held by the NSF. URL 17648 -5- Chairman Rail appointed Dr. Shapiro and Dr. Plumlee to contact Ralph Wands as soon as possible and see what needed to be done and report back to him. Dr. Rail will explore the problem of funding and the associated political problems. When he receives a report from Shapiro and Plumlee, he will report to the group. The question was raised as to what research the various agencies represented had planned. Dr. Plumlee stated that EPA was planning a teratology study. Rowe informed the group that Dow had essentially completed such a study and that information would be made available Rowe suggested that Plumlee contact Dr. Perry Gehring of Dow directly for details of the work in progress. Plumlee also indicated that they were planning some studies to measure co-stresses of ethyl alcohol, vinylidene r chloride and nutritional factors upon toxicological effects induced by vinyl chloride. Dr. Rail stated that NIEHS had . two projects which they were considering? one. Dr. Drew of his laboratory is going to prepare tissues from animals exposed to VC1 for Dr. Hams Popper to study, and two, NIEHS is hoping to enhance Dr. Selikoff's work in the epidemiological area. Dr. Fairchild indicated that they had not planned any further research since they felt, as the group assembled did, that before starting further toxicological studies they should know what is presently being done. He did indicate that they were continuing to support the epidemiological work that they had already started. Dr. Shapiro said that the FDA had no plans at the moment. Dr. Rail asked Rowe if he would summarize his notes of the meeting for distribution through the Chairman. Rowe agreed. Chairman Rail then adjourned the meeting at approximately 6 PM. Respectfully submitted. V. K. Rowe, Acting Secretary Dow Chemical U.S.A. 1003 Building Midland, Michigan 48640