Document kDd2NV1pbg9rdNvM7KdZjkQeO

X 2 7 1267 Harold J. Magnuson, M.D. Director THE UNIVERSITY OF MICH IQ AN INSTITUTE OF INDUSTRIAL HEALTH MEDICAL CENTER ANN ARBOR, MICHIGAN 48104/:, attachment January 25, 1967 Mr. Frank H. Carman Manufacturing Chemists Association Washington, D.C. Dear Mr. Carman As promised at our meeting in Ann Arbor on January 24, X wish to re-emphasize complete understanding of the absolute necessity of maintaining security on the confidential process and ingre dient information that we need to obtain to carry out the PVC study. This is by no means a new problem to us or to any of our staff who will be visiting these plants. I should like to suggest that either of two courses be followed depending upon the wishes of the individual companies. First, confidential and secret information regarding chemicals, their approximate concentration, the process in which they are used, and the time during which they have been used from January 1, 1960, to the present may be sent directly to me in a double envelope. The inside envelope should be marked "company secret"; the outside envelope should carry my address and should be sent by registered mail. On receipt at this office, this information will be seen only by me and will be retained in a security file to which I alone have access. During the analysis and reporting of the study, these compounds will be handled by a code known only to me. i- The second alternative would be to make this information available to our industrial hygienist when he surveys the plant with the understanding that this material would then be brought back to Ann Arbor, placed in the same security file, and otherwise handled ^in the same manner as material sent directly to me. rCIf we are to unravel this perplexing situation, it is absolutely essential that we have the detailed information that will permit inter-company comparisons. I suspect that these inter-company comparisons will make possible the elimination of many ingredients as potential offenders in a way that would be impossible in the absence of these confidential data. Sincerely yours Harold J./Magnuson, a.D. HJMimld 100872 Harold J. Maonuson, M.D. Director n THE UNIVERSITY OF MICHIGAN INSTITUTE OF INDUSTRIAL HEALTH MEDICAL CENTER ANN ARBOR, MICHIGAN 48104 !I attachment / January 25, 1967 Mr. Frank H. Carman Manufacturing Chemists Association Washington, D.C. Dear Mr. Carman As promised at our meeting in Ann Arbor on January 24, I wish to re-emphasize complete understanding of the absolute necessity of maintaining security on the confidential process and ingre dient information that we need to obtain to carry out the PVC study. This is by no means a new problem to us or to any of our staff who will be visiting these plants. I should like to suggest that either of two courses be followed depending upon the wishes of the individual companies. First, confidential and secret information regarding chemicals, their approximate concentration, the process in which they are used, and the time during which they have been used from January 1, 1960, to the present may be sent directly to me in a double envelope. The inside envelope should be marked "company secret"; the outside envelope should carry my address and should be sent by registered mail. On receipt at this office, this information will be seen only by me and will be retained in a security file to which I alone have access. During the analysis and reporting of the study, these compounds will be handled by a code known only to me. \ The second alternative would be to make this information available to our industrial hygienist when he surveys the plant with the understanding that this material would then be brought back to Ann Arbor, placed in the same security file, and otherwise handled in the same manner as material sent directly to me. If we are to unravel this perplexing situation, it is absolutely essential that we have the detailed information that will permit inter-company comparisons. I suspect that these inter-company comparisons will make possible the elimination of many ingredients as potential offenders in a way that would be impossible in the absence of these confidential data. Sincerely yours UCC 100873 v-Awp MEETING AT ANN ARBOR, MICHIGAN OCCUPATIONAL HEALTH COMMITTEE (MCA Sponsored --A meeting of cooperating PVC producers and the Institute of Industrial Health, University of Michigan) JANUARY 24, 1967 Attendees from Union Carbide Corporation were: Dr. E. Q. Hull Dr. C. U. Dernehl Mr. R. N. Wheeler, Jr This meeting was called to discuss tentative plans for an epidemi ological study within the PVC industry to determine, if possible, the cause and incidence of a possible occupational health hazard. The MCA proposes employment of the University of Michigan Institute of Industrial Health to make an industry-wide study of this problem. Dr. W. L. Sutton, Chairman, noted the following: 1. All participants should try and avoid discussion of the problem outside of the meeting. 2. Where discussion of the problem is unavoidable, it should be confined to the experience of the individual participants. 3. Any publicity or public information concerning the over-all study will be released by the University of Michigan Institute of Industrial Health. The content of the release has been approved by MCA. Each participant will be informed at the time of such a release. The objective is to avoid or neutralize unfavorable publicity. Doctor Magnuson, Director of the Institute of Industrial Health, pointed out that we know the following items: 1. The syndrome is relatively rare. 2. The largest prevalence occurs among PVC reactor cleaners. 3. The syndrome is not known to occur in fabricators of finished polymer. 4. Time is important. UCC 100874 2. The problem could be studied via a toxicological or epidemiological study. Tlie use of a toxicological study is not believed to be feasible because tiie syndrome is difficult to reproduce in animals. The epidemiological study will be confined to persons now employed in the production of monomer, polymer, and resin compounds. Data collected from the industry study will be compared to data collected from a study of the adult population of Tecumseh, Michigan. Members of the industry should take pains to be honest and coopera tivc; the data supplied should be as accurate as possible. The basic plan of the study is as follows: 1. Hand X-rays, occupational history, and medical history of each employee will be obtained and compiled by computer. 2. Control data from the population of Tecumseh, Michigan, will be computerized similarly. 3. Process information containing raw material lists, flow sheets, operating conditions, and concentrations of various materials within the process will be collected from participants and coded to preserve its confidentiality. 4. Plants of participants will be surveyed by a team of physicians and industrial hygienists from the Institute. 5. A study of data collected should permit identification of possible agents or conditions that cause the syndrome. There was considerable discussion with regard to the need for study of the monomer and resin compounding plants. While it was agreed there were no known cases in these areas, the need for bracketing tiie trouble area was believed essential. Unfavorable publicity with regard to exposure of finished products to tiie human anatomy could be very damaging to the industry. Tiie FDA generally insists that products be proved non-toxic. There have been no new developments since the meeting on October 6, J 966. Monsanto has X-rayed all employees producing PVC in their Springfield, Massachusetts plant without positive results. Esso Chemical lias examined all production, maintenance, and laboratory personnel at their Sarnia Plant without positive results. Tiie conduct of the study will involve tiie following: J. All participants will obtain hand X-rays, job history, and medical history of employees associated with tiie production, maintenance, shipping, and quality control of vinyl chloride monomer, polymer, and UCC 100875 3. resin compounds. Only employees currently working in these areas are to be studied. The job hisjtory shpuld go^ac.k toJanuary 1, I960, Medical examination other than hindX-rays is to be optional with participants and is not believed,to'J'bejessential/^^l^^.f; 1. Process information can be supplied .the visiting specialist or mailed directly to Doctor Magnuson by registered mail.%^Tne process informa tion should consist of flow sheetsj raw materials ,T arid other pertinent process data. Concentrations'of materials within the system may be defined in general terms, such as dilauroyl peroxide is less than 1%. Dates showing when use of a particular material was initiated or dis continued are desirable. Companies using licensed processes should study their licenses; they may have to obtain permission from their licensers to release the necessary data. Confidential process informa tion will be known only by Doctor Magnuson. 1. The University of Michigan Institute of Industrial Health will have the hand X-rays read by two radiologists. Each company will be informed of the results on their employees. 4. A team consisting of no more than six physicians and hygienists will visit each plant to study the facilities. They may want to examine a few representative employees. This examination is optional with participants. 5. The University of Michigan will compile all data and issue a final report to all participants. ; The study will take approximately six months, and they hope to have the first plant visit in about three weeks. The study at Union Carbide will be confined to the Charleston, Texas City, and Hound Brook plants per Dr. C. Ui Dernehl. R N Wheeler Jr / ra I)] )iLiL Copy to: Mr. J. H. Barrett (515) Dr. C. U. Dernehl NYO Mr. J. H. Field (515) Mr. L. E. Hall (514) Dr. E. Q. Hull (514) s Dr, R. E. Joyner (515) (3) r ' UCC 100876