Document NOYadZoqjB57wpJN25RQvDGg

ffotP<sc5tf(m \J INTEROFFICE date JA17UAET 14, 19?6 TO WE. TODD V/ALSSR POTISTOWir from DR. L. E. BLLLOU REFERENCE SUBJECT Attached is a copy of Mr. Bommarito's letter to Dr. Finklea relative to the January 5th meeting. Lou Belies;ky apparently authored it. It is quite favorable, I think. Boh Eassmiller and George Wilson agree. Attachment LH3:pk cc: Hr. B. Frazier sun 1900 SEVENTY FIVE YEARS OF QUALITY AND SERVICE 1975 * BFG61345 HWL BOMMAfc KENNETH OLDHAM. V>C Fridflt IKE GOLD. S*<rtty.TrtMfr UNITED RUBBER. CORK. LINOLEUM AND PLASTIC WORKERS OP AMERICA AFL-CIO. ClC 17 SOUTH HISH STREET AKRON, OHIO 44101 January 9, 1976 \&YA rarr^i CH 214 174.4111 174-4112 )74-4lll 1744114 John Finklen, K.D., Director National Institute for Occupational Safety and. Health Department of Health, Education and Welfare 5600 Fishers Lane, Parklawn Building Rockville, Maryland 20352 Dear Doctor Finklea: This is relative to a meeting held in ;.y offices on January 5, 1976 in Alcrcn, Ohio. The meeting was called at your suggestion and at your direct response to a request for such a meeting made to your office by Dr. Laurence Ballou, Corporate Medical Director of The Firestone Tire and Rubber Company. During the last three months or so, there has been considerable contro versy regarding the scientific release of data generate-.' from a multipartite study (URW/Firestone/University of North Carolina/*.'I0SK/UDC) conducted at our URW Local Union Mo. JJ6 (Firestone, pottstcun, Pennsylvania) during the later part of 1971i. . The basic issue raised by Dr. Ballou and Dr. KcKichael <UMC), was related to the information regarding "fetal wastage" and the presentation of the data at a meeting in Czechoslovakia. Their concern uas that nrener protocol was not reccanized as outlined in t'no original protocol agreement of July 9, 197L. Cn rages 1 and 2 of the protocol of the szucy (enclosed without appendices), the reference to the collaborative understanding is as follows: "It is the purpose of this study 1) to determine those diaipiostic laboratory procedures best suited for detection of liver disease among workers employed in VC polymerization and fabrication pro cesses; 2) tc identify rs completely as possible all current and former workers with liver abnormalities ro that they may be re ferred for appropriate medical evaluation and tneropy; and 3) to identify other medical illnesses conceivably related to either VCM or to polymerised VC (PVC). PRINCIPAL i:r.T'DTrC.`.mblS: ((< \ I f The study will be conducted .jointly ly the Bureau of Epidem iology (EL) (Canour and Birth Defects Division; and the National institute for Occupational Safety ami Health (l.'ICSH) (Division o 00 BFG61346 John Finkiea, K.D. Pare 2 January 9, 1976 ' of Field Studies and Clinical Investigations), Center for Disease Control (CDC) in collaboration with the Occu pational Health Studies C-roup, School of Public Health, University ,of North Carolina at Chapel Hill. Principal Investigators will be: 1. A. Scott Grivas, Jr., K.D.,EIS Officer, Cancer and Birth Defects Division, EE, CDC. 2. Joseph I'sllov, K.D., Medical Investigations Branch, Civison of Field Studies and Clinical Investigations, NIOSH, CDC. 3. A. J. HcMichael, M.D., Department of Epidemiology, Occupcticral Health Studies Croup, School of Public Health, University of North Carolina r.t Chapel Hill. k. Henry Falk, K.D., US C-fficer, Cancer and Birth De fects Division, BE, CDC. 5. Clark i.T. Heath, Jr., K.D., Director, Cancer and Birth Defects Division, EE, CDC. 6. Joseph K. V/agoner, S.D., Hygiene, Director, Division of Field Studies and Clinical Investigations, 1II05H, CDC. 7. Rick Waxweiler, Assistant Director, Division of Field Studies and Clinical Investigations, NIOSH, CDC." Also enclosed for your reference is a copy of the URU-Firestone "Kenorandum of Agreement" regarding our 1970 negotiated Joint Occupational Health Program Our tripartite understanding ar.d com.-d.trer.t is quite clear. In our initial meetings regarding a nolypartite involvement, we had hoped that cur comnitnent and stated feelings were to be honored. I am aware of the Public Information Disclosure Act and that the data prev iously referenced was, in essence, "outlie information." I am also aware that total commitment .cf the collaborators was a matter of a "gentleman1s agreement." Dr. Infante was not aware of the July ?, 197U protocol since he only joined NIOSii in August of 197:. The above issue was cleared ty statements from Doctors Ballou, Infante and Wagoner and further effort?; r-r.a er.de*"'ors regard?ng the 'Pottstown1 rtudy would, in the future, bo collaborative involving the principal investigators. ii i i i i j ii t-I o 1S1S0 BFG61347 John Finklea, K.D. Pace 3 January 9, 1976 The sif^iificsnce of the data on fetal wnstnre was discussed and all parties agreed that a preliminary reference snoula be submitted to Lancet for ... publication as soc.a as possible. The meeting will also reflect on the paper to be published as part of the Czechoslovakia neeting proceedings. The CDC representative, Dr. Heath, seemed reluctant to consider the con clusions reached" fron the questionnaire as either valid or significant. His corient of "garbnre in-rrarhs.re outI11 was generally unfavorably received and leads me to wonder if he was referring to the CLC, HIOSH, or the UHC inputs, and, a3 stated, seems to reflect on all three groups of scientists. Of concern is the fact that the continuity of the principal investigators was broken when CDC and lilOSH personnel left to pursue further studies at Harvard, the University of liorth Carolina, or Pittsburgh. The total study conducted at the Pottstoun plant has never produced a final report. The preliminary reports vrere relatively negative and await final* evaluation either by HICSH, CDC, UIJC's Jchocl of Public Health, or all three. The excerpted "fetal wastare11 is only a small part of the total effort. Numerous comments regarding tha terrato -necity and nutagenecitv of Vinyl Chloride were made, hut r.cne vrere adequate to help r.e in cermaiicating with our membership or relieving the fears or concern of our workers (cr their wives) regarding birth naiformr.ticr.s or fetal deaths. If this is a significant finding (and I have no reason to doubt the finding), it would not be "unique" to just the Fottstown workers. I therefore urge that investigations be made at other facilities where VCK exposures have occurred (3. F. Goodrich, Goodyear, Union Carbide, etc.). If this is just the chance, accidental occurrence of the misleading use of numbers, then this too must be documented. ' y* If the data are real, and TCM is in fact a human ruta pen producing fetal wastage, then this becomes a matter of public health concern and prope. notice and dissemination of such information must be made. Ames tests certainly indicate that VCM is a mutagen. Studies arc being conducted in other countries to evaluate the human mutagenic effect (Norway). I appreciate Dr. Sutler's effort in setting up a meeting in Akron. I feel that much was acccnpiished in maintaining credibility among the scientists involved, and that all nave a better understanding of theirs and rsy respon sibility to workers and the significance and impact of the data discussed. V'e are hopeful that you will expand your efforts to other VCI-1 users or PVC producers to resolve tliis situation. I also wish to than'.: HlCDH.for their input and concern regardin': the problems we have encountered at the n/.DK-'. yondoVto plant whore Vinylidcne Chloride may be implicated. Further study regarding hepatic injury of these and other workers would be helpful. N CO Q) w BFG61348 John Finklea, K.D. . Page h January 9, 1976 I wish to thank the I7IOSH representatives for taking .tine from their busy schedules to r.eet with us in Akron, and I will expect a copy of Dr. Eutler's notes regarding the meeting. Yours very truly. -. * Peter Eoimarito, International President PBspJs opeiu 329 PC: International Officers Director of Industrial Hygiene Eelicsky Industrial Hyrir-rist Carolyn Dell Firestone Coordinator Jd:e Killer Lawrence Ballou, II.D,, Corn. Kcdical Director, Firestone Jl. V. Hassniller, Manager, Labor relations. Firestone 2d Baier, Assistant Director, (Rockville) Bobby Craft, Ph.D., Division of Technical Services, III OSH (Cincinnati) John Butler, K.D., 1IICSH (Kockville) Robert Harris, ?h.D., Director, Occupational Health Studies Group (UKC) A. J. McHichaol, K.I)., Occupational Her 1th Stucies Group (UKC) Clark >7. He.-.th, K.B., Center for Disease Control (Atlanta) Joseph ;vV.oner, D.oo., Division of ?i<..id ana Clinical Studies, HICSH (Cincinnati) Peter Infante, K.D., KIOSK (Cincinnati) Hector Blejer, K.D., I7I0SK (Cincinnati) David J. Senser, K.B., (CDC, Atlanta) William Flynt, K.D., (CDC, Atlanta) m Enclosures: 1. Protocol (Medical Screening of Vinyl Chloride V7orkers) 2. Joint Occupational Health Program Memorandum (Firestone) Z5G181S; BFG61349