Document wKKj4kjkOkz6Ram1oJkdebxO3

G E N E R A L ^ ELECTRIC g eneral electric co m pany PAinriCLD, CONNECTICUT 00-4*1 STEPHEN B. HAMILTON. JR . manaocn - cnviwonnkhtal u u k h initiative Novenber 22, 1982 Or. J. Donald Millar, Director National Institute for Occupational Safety and Health Parklawn Building 5600 Fishers Lane Rockville, Maryland 20857 bcc: J. R. Donnalley R. S. Friedman S. P. Read Corey Trench - EEI Melodye Turek - EPRI Dear Dr. Millar: The General Electric Company was a major user of polychlorinated biphenyl (PCB) in the production of electrical transformers and capacitors. For this reason, and because of health concerns that have been raised about PCBs, we have been heavily involved In supporting research directed at understanding the hunan health implications of PCB exposure. The statement published by you in the Federal Register of November 1, 1982, announcing a field research project entitled, "Reproductive History Study of Women Exposed to Polychlorinated Biphenyls in the workplace", (47 F.R. 49471) was of considerable Interest to us. My first impression of the notice was that it described a study of a population of General Electric capacitor workers but that it contained several factual errors and one strictly gratuitous but extremely important statement about the himan carcinogenicity of PCBs. This statement runs contrary to the opinions of the best-informed scientists and physicians, including some of those in NI05H and CDC. I spoke to the project officer, Dr. M. Rosenberg, by telephone and confirmed that my first impression was correct. First the factual errors: 1. The plant in New York manufactures capacitors, not transformers, as stated in the Notice. 2. The study was already underway for several months when the notice was written on October 22, announcing that it would get underway on or about Decenber 13, 1982. My major concern is about the statement, "In animals and humans, PCBs have been found to be carcinogenic." with respect to animals, I think it is fair to say that PCBs have given conflicting and sometimes controversial results regarding the induction of liver cancer. There is little or no evidence from animal studies indicating carcinogenic potential in other tissues. / 735877 GENP00111 2- with respect to hunan carcinogenicity, Dr. Rosenberg has informed me that the file cites studies by Brown and Jones, Bahn et al and Zack and Mjsch. without discussing .the degree of support offered by each of 'these studies individually, my overall assessment is that all types of 'malignancies are not in excess, that excesses of individual types of malignancies are small, not statistically significant, and not consistent from study to study. If anyone in NIOSH seriously believes that the studies cited offer valid support for the NIOSH statement, I suggest that that person talk to Dr. David Brown, principal author of the most significant of the cited studies, or Dr. A. B. Smith, principal author of an authoritative clinical assessment of workers occupationally exposed to PCBs, both of whom are in NIOSH's Division of Surveillance, Hazard Evaluation and Field Studies, the organization from whence the notice issued; or Or. Renate Kimbrough of the Centers for Disease Control, who carried out the animal studies indicating induction of liver cancer in female German rats. Dr. Kimbrough has stated in her recent book, "Halogenated Biphenyls, Terphenyls, Naphthalenes, Dibenzodioxins and Related Products", that, "No conclusive evidence has thus far been reported which demonstrates that occupational exposure to PCBs has caused an increased incidence of cancer." As a previous major user of PCBs, General Electric has many former and current employees who have been exposed to PCBs. We feel it is extremely important to understand long-term implications of PCS exposure so that we can coamunicate with these people. At the same time, we deplore the output of media sensationalists who connect descriptions such as "cancer-causing", "deadly" and "extremely toxic" to PCBs without regard for scientific facts. Such statements give rise to irrational public fears'that in other instances have resulted in something akin to mass hysteria. An ill-advised statement from a United States Government organization, such as NIOSH, can lead to a similar result. The General Electric Company urges that you enter a correction in the Federal Register to both the simple factual errors and the statement about carcinogenicity at the earliest possible time. I look forward to an early response. Very truly yours. SBH:f ccs Dr. M. Rosenberg, NIOSH 735878 O O Stephen B. Hamilton, Jr. Manager Environmental Research Initiatives General Electric Company Fairfield, Connecticut 06431 Dear Mr. Hamilton: Thank you for your letter of November 22. We have reviewed this notice. The statement concerning the carcinogenicity of PCB's was incorrect and not consistent with our position as stated in the criteria document on PCB. We sincerely regret this error. In order to set the public record straight, we have printed a correction in the Federal Register on December 28 (copy enclosed). This correction states that the following sentence should be deleted, "In animals and humans, PCB's have been found to be carcinogenic". In its place should be substituted, "PCB's have also been found to induce tumors in experimental animals after repeated oral ingestion. Because of these findings, PCB's are considered to have carcinogenic potential in humans." The criteria document states chat PCB's have been found to Induce tumors in experimental animals after repeated oral ingestion. The document goes on to state that, because of these findings, PCB's are considered to have carcinogenic potential in humans. If you have any other questions concerning this matter, please do not hesitate to contact me. Sincerely yours, J. Donald Millar, M.D. Assistant Surgeon General Director 735879 uO>