Document B5kY9qEXZj79gvwEVgqK2vG8m

PLAINTIFF'S EXHIBIT U.TATE UOA1. MPIY 00. SUMMARY OF file cop iTOE0SEIggm98g0iteEPIDEMI0LQgI(ggMEPICAEy ANEaTOXICOLOCIC ^HH>13titePiUiSEMTEgy|fllaflnflSaNIOSH/.DCiiBRIEETNO*EQRigMANAGEtlECT- ^HBygABOBatEEREgSrEMHVESiEEUXtKrHB^VIMYir^HLORFDE^ANDSPOLY - jgBPS^tfltf^E**AMUBAgrURlM0^1NDUSTRXgS CEKVEtAUQ^omO JdBQOURXEBWSLZ^ 189J, EPIDEMIOLOGY It was agreed that: 2. In consideration of the potential scope and seriousness of this problem, NIOSH/CDC take the leadership in the govern ment to investigate the problem, assign it top priority, and immediately to provide or seek the necessary personnel and funds for implementation. This implementation shall Include cooperation with interested groups in government. Industry, labor, and elsewhere; 3. The Division of Field Studies and Clinical Investigations (DFSCI) within NIOSH/CDC take the lead in undertaking such steps as necessary to determine the full extent of the mortality and morbidity associated with VC exposure among occupational groups. There appear to be <fSur^fcategbri'cS'of"individualsTpotehtially' at risk from exposure to VC and in which exposure and health effects should be evaluated: 1. Production of the monomer VC; 2. The conversion of VC to PVC, both as pure PVC and as polymers containing other substances; 3. Thb..usevof EVCritt.: the;production of other"products; and 4. Consumer uses of PVC products. BFG39612 2- In the light of the unusual frequency of angiosarcoma of the liver In a single polymerization facility, first priority should be given to early ascertainment of the disease experience of the foregoing Group 2. The Inroedlate program should have the following elements: 1. DFSCI/NIOSH in cooperation with the Office of Occupational Health Surveillance and Biometrics (OOHSB) would be involved in: a. Assisting Tabershaw/Cooper Associates in any way possible to complete the mortality study of workers at the B. F. Goodrich FVC operations in Louisville. b. A governmentally-sponsored epidemiological study of the health hazards associated with the production of PVC. (1) An attempt will be made to: <*) Document the incidence of angiosarcoma of the liver in workers in facilities other than the B. F. Goodrich plant in Louisville; 00 Document the incidence of malignant and nonmalignant disease in PVC workers; (c) Define the real or potential hepatotoxins among the materials used in the production of PVC; and W Document the state of environmental control in the VC/PVC operations. Involving sampling and analysis, work practices, ventilation design, etc. (2) Five criteria are to be use^ (listed in descending order of priority) to determine which plants will be studied: . (a) PVC production history of 15 or more years; BFG39613 3 (b) Size of vork force; (c) Polymerization Involving vinyl chloride with . end without vlnylidene chloride; (d) Location In States where vital statistics Information Is readily available; and (e) In-plant medical program. Hote: Already contact has been made with 18 of the . 37 known FVC facilities. Using the above criteria, there Is a clustering of plants in the tri-State area of Ohio, Kentucky and Pennsylvania. (3) Concurrently, rosters will be developed of both pres ently employed workers in VC/FVC operations as well as those employees who have moved within or out of the Industry. c. A determination'of the extent of use and distribution of FVC among users of the polymer to estimate the exposure to VC .or PVC under such circumstances (Contract mechanism). 2. CDC will follow 'hrough with Its surveillance program In the development of a registry for the identification, review, and workup of cases certified as having angiosarcoma, other liver cancers, and other diseases that may appear to be pertinent on death certificates. At the start, this will entail tracing such . cases from death certificates recorded for recent years at the Hatlonal Center for Health Statistics and in vital record de partments within individual states. Sufficient detail will be obtained for each confirmed case to permit evaluation of case incidence with respect to geographic distribution, secular trends, and occupation. As the surveillance program develops, additional sources of case ascertainment will be used including contacts with tumor registries, cancer treatment centers, and Industry groups. 3.' HIOSH/CDC will cooperate with other Federal agencies, such as the Food and Drug Administration and the Consumer Product Safety Commission in obtaining information on the use (past and present) and distribution of VC/PVC in aerosol sprays and other household products. NIOStI will also work closely . with the National Cancer Institute regarding the State of knowledge of hepatic cancer. Hote: All of the above activities are to proceed apace and concurrently. BFG39614 -4- HEDICAL A major immediate cone:*;; terI. fr* VC-related industries and for the government in its pron'c-tor <*wirr -i ilogic investigation of the angio sarcoma question vill ' in>, ? industrial populations for clinical evidence of di .-.p-j ; .; -:icuUy related to the VC- polymerizatlon process. . v` d-^se encompasses not only angio sarcoma of the liver, but also non-mallgnant hepatic conditions (cirrhosis), and perhaps other types cf cancer and non-hepatic disorders as veil. To consider what medical screening procedures are appropriate in this setting, NIOSH/CDC plans in the near future to convene a panel of medical consultants specializing in liver disorders. This panel will review the clinical and pathologic material accumulated to date concerning VC related disease in this country and abroad, and vill make specific recommendations to the government vi-h respect to medical screening and followup of potentially at-risk induitrial populations. TOXICOLOGY NIOSH/CDC will take the lead role In determining needs for experi mental animal toxicologic studies. Before developing the protocols, it will be necessary to evaluate the world literature on toxicology and to review the potocol and results of recent and current experi ments conducted in the U.S. and Italy. In developing research protocols, NIOSH will work with members of the HEW Committee to Coordinate Toxicology and Related Programs. Many factors and parameters will have to be considered in the development of the experimental design of the study, including species differences, metabolic fate of the inhaled or absorbed VC; dehalogenlzation of VC, alkalatlng properties and mechanisms, gas-off products of PVC, toxicology of PVC dust, and effects of low-level exposures to VC. NIOSH does not envision the experiments being done in-house, but rather in one of the other government facilities or by private contractors. BFG39615 AttenBees at NICSH/CPC briefing on vinyl chloride, Cleveland, 2/12/74 * Fro Industry V. K. lllff tfBBHIKBl Chemical Division, Painesville, Ohio B R. l^*eh,Chcaicsl Division, Painesville, Ohio X. B. Katsennever.APBgSggqgaritth. Akron, Ohio Herman Waltemate. FifrGSSSASJEtt Chesilcala. Cleveland, Ohio K. S. Mather.AgjHIMgDasartaf Chemicals. Avon Lake, Ohio B. Cohen, Great American Chemical Corp., Fitchbufg, Mass. - John C.-Floros, Great Asterican Chemical Corp., Fitchburg, Mass,__ 0. Paul Cohen, Great American Chemical Corp., Fitchburg, Mass. Carl H. Dernehl, iffniohrCarbidKCorp~. T New York City Lawrence H. Ballou,^&<^3^Tire & Rubber Co., Akron, Ohio George L. Wilson,^girgs^prie7 Tire & Rubber Co., Akron, Ohio Robert S. Brookman./FiPhTtoS^Tire & Rubber Co.', Pottstcwn, Pa. George Roush Jr., Monsanto Compa'ny, St. Louis, Ho. Robert L. Bourgct, Monsanto Company, Springfield, Mass. W. L. Small, Monsanto Company, Texas City, Texas Theodore Torkelscn, Dow Chemical Co., Midland, Mich. C. A. Christian, Dow Chemical Co., Freeport, Texas D. A. Rausch, Dow Chemical Co., Midland, Mich. t Charles B. Kramer, Dow Chemical Co., Midland, Mich. 9 George Harris, Liberty Mutual Insurance Co., Cleveland, Ohio BFG39616 From Industry (continued) V* X. Rinehart, Ethyl Corp., Hw York City ^'B. Lindquist. ^Blgfg Chemical Company If. M. Johnson. tO$4BBB3BSBBKHSt Co. V. X. Mlller(4BBBSSZVTire ft Rubber Co. Herbert H. Caster, Hooker Chemical Co. F. R. Klebacher, 01 tn Corp.-PVC Resins J. F Cabbett. Chemicals Stanley J. Anton, Panasote Co. Roy V. McCune, Pantasote Co. of Kew York, Inc. J. R. Mudd. Henry Rzenpoluch, Pantasote Co. of New York Albert Cover. g&g Co. J. Robert Mehall^Pt^Sfiiu&rcglFCo. Richard Haler./SEffffffetf Chemical Co. L. N. Vernon ./CgKbd^Chenlca 1s Mayo Smith, Air Products & Chemicals Henry L. Schmidt Jr., Borden Chemical Division Darwin E. Rhoad*, ^TennecoChealcala Co, Raymond J. Abramowlts, Hooker Chemical Co. J. C. Palinsky, Universal PVC Resins Inc. Janes P. Turner,JKanufifetur ing Chemists Association R. V. Modre 11,-Goodyear Tire & Rubber Co. Clifford A. Johnson, MD, Coodyear Tire k Rubber Co. Vayne T. Brooks, Organization Resources Counselors R. N. Wheeler Jr., Union Carbide Cotp. . From Industry (continued) .Barry A, Lloyd, Geor R.*l. Reward, Shell Chemical Co. Kenneth Q. Johnson. <aCtfttflBgETSgIgECgaiatatarAroelagIon; Washington, D.C. J# R. Johnston, leperis1 Oil Limited, Toronto, Ontario, Canada . L'F. Sargert, PPG Industries, Pittsburgh, Pa. V. A. Knapp, Allied Cheeical Corp., Morristown, N. J. F. M. Toca, MD, Gulf Oil Corp., Pittsburgh, Pa. Zeb C. Bell Jr.v PPG Industries, Pittsburgh, Pa. Lloyd M. Vdlker, Western Electric, Colunbus, Ohio K. V. Hendricks, Exxon Corp., Hew York City J. R. Ll^vingston Jr., Exxon Chemical Co., Linden, K.J. Proa LabornUnions George Perkel, Textile Workers Union of As^rlca Jeanne Stellman, Oil, Cheeical and Atomic Workers Steve Vodka, Oil, Cheolcal and Atonic Workers Tony Maxzocchi, Oil, Chemical and Atomic Workers R. Boeasarlto, United Rubber Workers Louis S. Belicry, United Rubber Workers Warren J Smith, Ohio AFL-CIO Salvatore J. Falletta, International Chemical Workers Union Sheldon Saauels, Industrial Union Departnent, AFL-010 (r-J m &0081/ZSZ BFG39618 From C...o..lleges and Oni.veraI.ttes ...................... . Henry A. Anderson, M), Mt. Sinai School of Medicine, Rev York 4rrln| J. Snlikotf, H>, Mt* Sinai School of Medicine, Few York Ruth Vilik, M), Mt. Sinai School of Medioine, Mew York David A. Praaer, University of North Caroline Xobert L. Harris, University of North Carolina Saauel S* Epstein, Case-Vestern Reserve Medical School Rudolph J. Jaeger, Harvard University School of Public Health free Government Robert L. Knarr, CSKA, Cleveland, Ohio John Pierro, Ohio Department of Industrial Relations Cray Holcomb, Ohio Department of Industrial Relations Cary Bryne', Ohio Superintendent for Safety It Hygiene Jon M* Cope, Ohio Department of Industrial Relations Warren Piver, National Insitutute for Environmental Health Sciences Howard I*. Kusnetz, NIGSH (retired), Houston, Texas Donald J, Blllmaler, HD, Ohio Department of Health From The Press John Nussbaua, The Plain Dealer, Cleveland, Ohio Jane Brodie, The New York Times, New York City Tea Peare, Chemical and Engineering News, Washington, D. C. Rick Snider, Occupational Hazards magazine, Cleveland, Ouio Hank Cox, Bureau of National Affeirs, Washington, D. C. Arthur Zimnerman, HcCray-Hill News bureau Robert Warastedt, Business Week 'a /-'! v BFG39619