Document R3X3jDenD7zx7kjXo68Bg3dn

A UNITED STATES ENVIRONMENTAL PROTECTION AGENCY BEFORE THE ADMINISTRATOR In re: Proposed Toxic Pollutant Effluent Standards for Polychlorinated Biphenyls -______________________________________ ) ) ) ) ) FWPCA (307) Docket No. 4 r AFFIDAVIT OF ROSCOE M. MOORE, JR. Roscoe M. Moore, Jr., being duly sworn, deposes and, says: 1. I am currently employed as an epidemiologist by the National Institute for Occupational Safety and Health (NIOSH), at 5600 Fishers Lane, Rockville, Maryland. My biography is attached to this affidavit as exhibit 1. 2. As part of my duties at NIOSH I was'involved in the preparation of a "Dear Colleague" letter" which was sent out on August 20, 1976, by Dr. John F. Finklea, Director of NIOSH. A . copy of that letter is attached to this affidavit as exhibit 2. 3. In this letter NIOSH reviewed the preliminary results of an epidemiologic analysis based on medical records of Mobil Oil Company employees exposed to PCBs at Mobil's Paulsboro, New Jersey plant. 4. Among the 92 workers studied, for whom adequate medical records were available, eight cancers (in seven workers) were # ` DSW 307413 STLCOPCB4069823 .( 2T observed between 1957 and 1975. Of these eight cancers, three were malignant melanomas and two were cancers of the pancreas. This is significantly more skin cancer (melanoma) and pancreatic cancer than would be expected in a population of this size (based on the Third National Cancer Survey). 5. Based on these findings and those reported earlier on the carcinogenicity of PCBs in test animals, it is my conclu sion that when the results of further studies on occupationallyexposed individuals are completed, there is strong'likelihood that PCBs will be shown to be carcinogenic to humans. */ 6. NIOSH is currently conducting such follow-up studies on workers occupationally exposed to PCBs. Sworn to and subscribed before me this November, 1976. Notary Public My commission expires: STLCOPCB4069824 ' - 1 ' 1)R. RQSCOE MICHAEL MOORE, JR. / ADDRESS: 14315 Arctic Avenue Rockville, Maryland 20853 . TELEPHONE: 301-871-8578 (Home) 301-443-3843 (Office) * _ ' BORN: December 2, 1944 -- Richmond, Virginia FAMILY: Wife: Patricia Haywood, B.S. in Nursing, Tuskcgee Institute, 19G6; C.R.N.A., School of Anesthesia, University of Michigan, 1969. Son: Roscoe Michael Moore, III, born May 16, 1971 Son: John Haywood Moore, born April 6, 1973 r EDUCATION ' Tuskegee Institute, Tuskegee, Alabama, 1962-1965, B.S. - 1968 ` Tuskegee Institute,- Tuskegee, Alabama, 1965-1969, D.V.M. / Chairman of the Honor Code, School of Veterinary Medicine, 1967-1968 President of Student Chapter of the American Veterinary Medical Association, Tuskegee Institute, 1968-1969 Congressman to the Student Government Association,'Tuskegee Institute, 196S-1969 . . Who's Who in American Colleges and Universities, 1968-1969 University of Michigan, Ann Arbor, 1969-1970, M.P.H. in Epidemiology - University of Maryland, College Park, February 1971 - May 1971, evening course in Spanish - CONTINUING EDUCATION PROGRAMS Fortran Training Course at the Center for Disease Control, November 8-12, 1971 Pe sticidcs and Public Health Training Course, sponsored by the Environmental Protection Agency (EPA), February 1-4, 1972, AtlanLa, Georgia Advanced Course - Pesticides and Public Health, sponsored by EFA, May 16-19, 1972, Atlanta, Georgia . oS'H STLCOPCB4069825 CONTINUING EDUCATIONS PROGRAMS (COH'T.) (Jrid Management Course,sponsored by Scientific Methods, Inc., October 21-26, 1973, Morristown, New Jersey Neurology Course, sponsored by D.C. Academy of Veterinary Medicine, April 4-5, 1974, Fairfax, Virginia , * Pharmacology Course, sponsored by the Food and Drug Administration, May-June, 1974, Rockville, Maryland Immunology Course, presented by Johns Hopkins University, October 25 - December 11, 1974, Rockville, Maryland Comparative Pathology Course, sponsored by the Department of Defense, Armed Forces Institute of Pathology, May 10-12, 1976, Washington, D.C. WORK EXPERIENCE January 1976 - Present '. A Veterinary Medical Officer in the U.S. Public Health Servioe, stationed at the- National Institute for. Occupational Safety and Health (NIOSH), Rockville, Maryland. Chief, Technical Evaluation and Review Branch, Office of Extramural . Coordination and Special Projects (OECSP), NIOSH, with primary responsibility in conducting and coordinating short-term technical studies including evaluation of toxicologic information transmitted to the Institute for review. Also, maintaining and supervising . the NIOSH Current Intelligence System. This system prepared back ground information on potentially hazardous substances in the occupational environment including toxicity to man and animals, production and uses, and the potential population at risk. This system informs the occupational health community, other government ' agencies, management, labor and public interest groups of new information on potential occupational health hazards. In addition, as Epidemiologist'for the Office of Extramural Cooi'dination and Special Projects, provides the necessary sta tistical and epidemiological information to quantitate the relative risk.of human exposure to chemical substances in the work environment. 0,0"! bP 0s STLCOPCB4069826 'WORK EXPERIENCE (CON * T.) December 197A - January 1976 . A Veterinary Medical Officer in the U.S. Public Health Service, stationed at the National Institute for Occupational- Safety and Health (NIOSH), Rockville, Maryland. . -) Chief, Priorities Evaluation Branch, Office of Occupational Health Surveillance and Biometrics (OOHSB), NIOSH, with primary responsi bility in directing the development, implementation, and maintenance of the Priorities Evaluation System which provides guidance to the Institute Director and the NIOSH scientific staff for the allocation of resources to assure maximum effort in combating health hazards in the work environment. In addition, as Senior Medical Epidemiologist for the OOHSB, provide the necessary statistical and epidemiological information to quan titate the relative risk of human exposure to chemical substances ' in the work environment. July 1973 - December 1974 ' A Veterinary Medical Officer in the U.S. Public Health Service, stationed at the Food and Drug Administration (FDA), Rockville, Maryland. .' A Surveillance Officer, Bureau of Veterinary Medicine, Food and Drug Administration with major responsibility in evaluating the safety, reliability, and efficacy of veterinary drugs for the target species as well as human safety with respect to tissue residues in food animals. Also, have been active in drug residue monitoring in edible tissue while serving as FDA consultant to the States of Wisconsin and New York. In addition, a member of ' the Project Advisory Group on FDA contracts for Heavy Metals Research. Primarily functioning as a toxicologic epidemiologist for the Bureau. ^ ' July 1971 - June 1973 ' A Veterinary Medical Officer in the U.S. Public Health Service, stationed at the Center for Disease Control (GDC), Atlanta, Georgia. ' An Epidemiologist with the Epidemic Intelligence Service (EIS) with primary responsibility for national psittacosis, listeriosis, viral pox, Venezuelan equine encephalitis, and animal bite sur veillance. A consultant to Family Planning Activities at CDC to develop animal models for reproduction and population studies. Also, CDG Liaison, Rabies Control Program, Dade County, Florida. In.addition, consultant to the Alabama and Florida State Health Departments on Lead Toxicoses. yO1 STLCOPCB4069827 WORK EXPERIENCE (CON'T.) September 1970 - June 1971 Senior Assistant Veterinary Officer in the U.S. Public Health Service, stationed at the National Institutes of Health (Mill), Bethesda, Maryland. . * A member of the Animal Disease Investigation Service with major responsibility for prevention and control of diseases within the germ-free and specific pathogen-free animal colonies at NIH. In addition, assisting NIH Investigators with research problems related to animal disease. Summer 1968 '. . Worked as a Veterinary Trainee with the U.S. Department of Agriculture, Animal Health Division in the State of Georgia. Summers of 1965 and 1967 A tutor in the Tuskegee Institute summer education program, a poverty program operating in the "Black Belt" counties of Alabama. Taught biology in special science centers to high school aged children in this program. . While in School at Tuskegee . I financed my education through Work Study7 Program, Federal loans, and scholarships. PERSONAL Professional Affiliations Member: American Public Health Association Action Board Member (1974-1976) Joint Policy7 Committee Member (1975) American Association of Food Hygiene Veterinarians American Association for Labor'atory Animal Science American Society of Laboratory7 Animal Practitioners American Veterinary Medical Association - Conference of Public Health Veterinarians Drug Information Association Society7 for Epidemiologic Research dS\N 30^8 I STLCOPCB4069828 Professional Affiliations (con't.) . . . Member by Election: . . American College of Veterinary Toxicologists (Associate Fellow) Society for Occupational and Environmental Health Veterinary Cancer Society - * Appointments: An Advisory Committee member on curriculum for the School of Agriculture and Natural Resources, Washington Technical Institute, Washington, D.C. (1974 - Present) External Reviewer for the National Cancer Institute's Bioassay Program (Trichloroethylene, Chloroform) (1975 - Present) NIOSH Occupational Carcinogenesis Task Force - Working Group on Mutagenicity Testing (1975 - Present) Awards .. United States Public Health Service (USPHS) Commendation Medal Award, April 2, 1976, for outstanding performance in the develop ment of a Current Intelligence System for the National Institute for Occupational Safety and Health, and dedicated service to the occupational health mission of the organization. Licensure Licensed to practice Veterinary Medicine in Alabama, fGeorgia, and Virginia. . * Non-Professional Affiliations Alternate delegate representing the Division of Research Services (DRS) at NIH in the Recreation and Welfare Association (1970-1971) ' A member of the Director's Advisory Committee of DRS. This com mittee is concerned wittr equal employment opportunities with DRS at NIH (1970-1971) A member of the National Wildlife Federation (1970 - Present) An Associate Member of the Intcrreligious Foundation for Community Organizations, Inc. (1974 - Present) An Associate Member of the American Committee on Africa (1974 - Present) Hobbies A philatelist and tennis enthusiast osW 30V419 11 STLCOPCB4069829 PUBLICATIONS Moore, R. M., Zehmer, R. B.' Listeriosis in the United States. 1971. J. Infect. Dis., Vol. 127:610-611, 1973. Moore, R. M. Human Orf in the United States. 1972. Dis., Vol. 127:731-732, 1973. . _ 4 : J. Infect. Moore, R. M., Zchmer, R. B., Moulthrop, J. I., Parker, R. L. Surveillance of Animal Bite Cases in the United States. 1971-72. Arch. Environ. Hlth. (In Press) ` .Moulthrop, J. I., Moore, R.' M., Parker, R. L. Venezuelan Equine Encephalitis Surveillance in the United States. 1972. J. Infect. Dis., Vol. 127:572-573, October 1973. Durfee, P. T., Moore, R. M. Human Psittacosis in the United States. 1971-1973. J. Infect. Dis., Vol. 131:193-194, 1975. Lloyd, J. V., Decoufle, P., Moore, R. M. Background Information on Chloroprene. J. Occu. Med., Vol. 17:263-265, 1975. Lloyd, J. W., Moore, R. M. , Breslin, P. P. Background Information on Trichloroethylene. J. Occu. Med., Vol. 17:603-605, 1975'. Kaufwann, A. F., Moulthrop, J. I., Moore, R. M. A perspective of Simian Tuberculosis in the United States. 1972. J. Med. Primatology, Vol. 4:278-286, 1975. Lloyd, J. W. , Moore, P.. M., Woolf, B. S., Stein, H. P. Poly chlorinated Biphenyls. J. Occu. Med., Vol..18:109-113, 1976. . Levine, R. J., Moore, R. M., McLaren, G.j Barthel, V7. F. , Landrigan, P. J. Occupational Poisoning, Animal Deaths, and . Environmental Contamination at a Lead Scrap Smelter. June Issue, AJPH, 1976. '. Moore, R. M., Moulthrop, J. I., Sather, G., Holmes, C. L., Parker, R. L. Venezuelan Equine Encephalitis Vaccination Survey in Arizona and New Mexico. 1972. Public Health Reports (Submitted). Moore, R. M. The Epidemiology of Animal Bite Cases in the United States. Proceedings of the 11th (1976) Annual Veterinary . Symposium, School of Veterinary Medicine, Tuskegee Institute (In Press). PUBLICATION EXPERIENCE ` . Prepared monthly surveillance reports for the Center for Disease Control concerning listeriosis, psittacosis, and Venezuelan equine encephalitis from 1971 to 1973. DSW 307420 STLCOPCB4069830 .- ' . . ' kUDLIC SPEAKING '. . ' Chaired session at the 102nd Annual Meeting of the APIIA in New Orleans on October 22, 1974, entitled "Zoonoses and the Non-White and Poor." . "Public Health and Legal Significance of Drug Residues in Food Animals" presented at the Ninth Annual Symposium, School of Veterinary Medicine, Tuskegee Institute, Alabama, April 9, 1974. "Environmental Lead Contamination - Effect of Humans, Animals, Soil and Plants" presented at the Annual Epidemic Intelligence Service (EIS) Conference at the Center for Disease Control (CDC) in Atlanta, Georgia on April 9, 1973. "Equine VEE Vaccination Survey, 1972" presented at the Annual EIS Conference at CDC in Atlanta, Georgia, April 13, 1973. "The Epidemiology of Animal Bite Cases in the United States" ' presented at the Eleventh Annual Symposium, School of Veterinary Medicine, Tuskegee Institute, Alabama, April 12, 1976. DSW 307421 STLCOPCB4069831 4 <fC. 2^ DEPARTMENT OF HEALTH. EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE CENTER FOR DISEASE CONTROL August 20, 1976 NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH 5600 FISHERS LANE ROCKVILLE. MARYLAND 20852 Dear Colleague: ' In a June 24, 1976 letter, Mobil Oil Corporation advised the National Institute for Occupational Safety and Health (NIOSH) of a possible association between occupational exposure to polychlorinaXg-d-'biphenyls (PCBs^ and cancer in humans. Mobil Oil reported preliminary results of an epidemiologic analysis based on medical records of employees exposed to PCBs at their Paulsboro, New Jersey plant. This study was conducted by Professor Anita K. Bahn (School of Medicine, University of Pennsylvania) and is being reported by Dr. Bahn in a letter to the .editor of the New England Journal of Medicine, August 19, 1976. The study included two cohorts of Mobil employees who were reported to have had varying exposure to Aroclor 1254 (a mixture of PCBs). The ' .cohort of research and development employees was exposed to PCBs be tween 1949 and 1957 and the cohort of refinery plant employees between 1953 and 1958. The extent of exposure of these workers to other chem icals is not known. The cancer incidence among these workers for the period 1957 through 1975 was determined using Mobil medical records. . Because medical records for 37 employees were incomplete, these workers ` were excluded from this analysis. Among the 92 workers in these two cohorts for whom adequate medical records were available, eight cancers (in seven workers) were observed between 1957 and 1975. Of these eight cancers, three were malignant melanoma and two were cancer of the pancreas'. ([This is significantly more skin cancer (melanoma) and pancreatic cancer than would be ex pected in a population of this size (based on the Third National Cancer Survey) The remaining cancers were found at three other sites ' in two employees; sarcoma of the right thigh and multiple myeloma in one employee, and recto-sigmoid cancer in the other. STLCOPCB4069832 J Page 2 - Dear Colleague NIOSH is unaware of any other published animal or humandata which sug gest a correlation between exposure to PCBs and skin (melanoma) or . panCVeaTic~cancer.~~ However7'hepatomas (mice, Aroclor 1254) and hepatoceixular carcinomas (mice, Kanechlor 50*0; rats, Aroclor 1260) have been reported in PCB feeding studies of laboratory animals. Background information on PCBs has been summarized in the NIOSH Current Intelligence Bulletin on Polychlorinated Biphenyls issued to the occupa tional health community on November 3, 1975, and subsequently published in the Journal of Occupational Medicine, Volume 18, pages 109-113, February 1976. Since the NIOSH Bulletin was first issued, a number of large firms have introduced products (e.g., butylated monochlorodiphenyl oxide and dimethyl siloxane polymer) claimed to be fire resistant dielectrics which can serve as alternatives to PCBs. In addition, one of the large domestic transformer manufacturers announced that it will cease using PCBs as fire resistant transformer fluids at the end of this year. NIOSH would like to stress that alternatives for PCBs should be thoroughly studied to assess the consequences'they may pose to human health. ^ ' .* .i To aid in evaluating PCBs as a potential occupational health problem, . NIOSH would welcome receiving reports of studies regarding the possible association between exposure to PCBs and human cancer. Your cooperation in this matter is appreciated. Sincerely yours, 'John F. Finklea, M.D. Director DSW 307423 STLCOPCB4069833 I April 27, 1976 REPORT ON PAULSBORO,`N.J. . MOBIL OIL PLANT STUDY "- ' ' Department o f Community Medicine . University of Pennsylvania School of Medicine . I I - - -Anita K. Bahn, M.D. , Sc.D. Professor of Community Medicine (Epidemiology)* \ \ 1 I 1 1 . J '* . Assisted by I. Rosenwaike, M.A.'; N. Hermann, Ph.D. ; 3'. Grover, Ph.D. ; J. Stellman, Ph.D., University of P< ennsylvania - Fox Chase Cancer Ce nter. ' .* - DSW30?424 STLCOPCB4069834 ' ' * OUTLINE OF REPORT - . *- INTRODUCTION * - Resume of Literature .i * ' ' .. METHODOLOGY ' ` I. Data for the Research and Development Employees. ' II. Data for the Refinery Employees FINDINGS . i. . ' DISCUSSION OF FINDINGS AND. LIMITATIONS OF T1IE D/VIA ' RECOMMENDATIONS i' TABLES ` * ' '. . '. . . APPENDIX: LITERATURE REVIEW `. ' \ i t i ,/ . _ * . s * * * * ' DSW 307425 I STLCOPCB4069835 1 . * INTRODUCTION . - - *. ' * . `In the Fall of 1975, the Medical Director and the management at Mobil Oil became aware of possible health hazards due to'exposure to polychlorinated biphenyls (PCBs) among two small groups of employees at their Paulsboro, New Jersey plant. Although PCB has not been in use for some time, the possibility exists that late effects such as cancer or liver disease could result from such exposure. The . latter has been noted in experimental animals. A thorough examination of available medical records was promptly made by Dr. J. Rodney Meredith, Medical Director of the plant. These ^ records were supplemented with other sources of information with regard to exposure to PCB. . The report that follows is a preliminary -epidemiologic analysis of the data furnished to us by Dr. Meredith. Suggestions, for further 'i t ' epidemiological studies are also included in this report. . iI I i i ii os***426 STLCOPCB4069836 2 Resume of Literature ^ ^tailed literature review has been included as an appendix. 1\ s4mmary is presented here, polyc^^ j nated biphenyls (PCBs) describe a group of synthetic Cf,lnrlnatc.d organic compounds, which have been manufactured in the c*nc^' 1929 and have been widely used in industry. Commercial I i , VCJW are 9 enerally mixtures of many different chlorinated biphenyls. ?254, a trademark of the Monsanto Co., is a mixture of CfJ/Inf*na^eQ biphenyls and contains 54% chlorine. * PCBs &re nQt easily metabolized and tend to accumulate in . tis sue. Polychlorinated biphenyls were found in measurable fjfti/iiihts irj 1% of- 637 samples of human adipose tissue collected f'/M/ii General population in 38 13. S. cities. ' ^ h*s been reported that workers engaged in the manufacture 0f /jfochlc-j. were affected with acne-like condition on the face tttid neck arjjj -that fumes may penetrate the clothes and cause acne-like Inris develop on the covered parts of the body. . In aij outbreak of poisoning in Japan due to ingestion of rice bj fill ^nich had been contaminated by PCB (Kanechlor 400) common uyiiijil.oms deluded: pigmentation of the skin, acne-form eruptions ` ir.vi follicu2ar accentuation, increased eye discharge and swelling of cye^ids, <ind feeling of weakness. 7\ dose-response relation ** ^"crv6d. Children born to mothers who had eaten the contaminated ' .# 'ft Wf r a rc smaller than averaqe and had discolored skin, although . c ^ldren grew older the stained skin gradually faded. . . DSW 307427 STLCOPCB4069837 '3 Hats fed hrochlor showed more liver abnormalities including hepatocellular carcinomas than did control rats. No unusual features * were noted in tumors of other organs, and there were no apparent differences in incidence in tumors between experimental and control animals. - The results of applying.a mixture of isomers of chlorinated . biphenyls to the skin of guinea pigs, rats and rabbits were: (1) changes of the liver among guinea pigs (2) liver and skin changes among rats and rabbits. ' Reproductive failure has been noted in monkeys exposed to PCB. ' DSW 307428 STLCOPCB4069838 !?]V. JjL* , .jmi ,hfcCh jIi.i'aW 4 # .4 , ` METHODOLOGY X. Data for the Research and Development Employees A. Study group and exposure ' . Sixty-four Research and Development employees are reported to have been exposed to Arochlor 1254 in the interval between 1949 and 1957, Of Che 64 men, 35 are still employed by Mobil;. 29, including 3 deceased employees, are no longer employed (Table A), For 16 ' of the 29 not currently employed, medical information is missing on an average for only the last two to three years * therefore, these men are included in the analysis. (Table B); / For the remaining' 13 men there is no Mobil medical record or follow-up information for the * * past 12 years or more; therefore, these 13 are excluded from this analysis. .' . ' . Based on exposure data estimated by an employee. Bob Wilson, the . 51 men included in the analysis were divided into two groups: (a) exposed to contact with forming oil, and (b) other ("probable", "unlikely", "unknown") exposure. Another observer, Ed Rosinski, developed a scale attempting to quantitate exposure. A summary of the total group (64) and the observed group (51) cross-classified on the two ratings (Wilson and Rosinski) is shown in Table C. It should be noted that the 13 persons excluded from the analysis are about evenly divided between the (a) and (b) exposure groups (7 and 6 respectively) . `- ' DSW 307429 STLCOPCB4069839  ' .. ' . _ .: 5 . ' ' . B* Observation period . ft 6 D employees were exposed to PCB f.ox various times during the years 1949-1957. The exact dates of exposure were not indicated in the material we used. For this analysis, therefore, observation time was assumed to be December 31, 1957 through December 31, 1975. This procedure understates the. observation period (if the average beginning point is assumed to be midway between 1949 and 1957, i.e., 1953) but at the same time allows for an average minimum cancer / induction period of about four years. . Information on age was'available for all 51 employees. / Person year's of observation by age category were constructed for the'51 employees for the 18-year interval between 1957 and 1975. (It was i. assumed that age reported for current employees is as of 12/31/75),, ( j| ' I' J. ii }. ? i . . . . .. ' * . * ^ ` . ... * . .. . . - DSW 307430 r STLCOPCB4069840 fit rfurt-TVft -a HJ+nM" . 6 .,.idnumber of new cancers c. ErfJJ;---------------;------------------------------------------ ' . .ji^ptcd incidence of cancer among the group under study E^*/ . I he ceriod 1957-1975 was based on the Third National during "' . inr\v incidence Data (NCI Monograph 41, March 1975) which Cancel ' ' . . , . Incidence rates by sex, race, and five year age groups reportr- ' - , ,,#,11-3 971. Our expected values were based on rates for male: for 19"' ,;^s) , by age, but are rough, for the following reasons (all rr--*7 * 0j Incidence rates for males have tended to increase over , I he levels in 1969-71 may be slightly higher than that tame s'' ^ ' ,/ during the 1957-75 period. However, our.use of the 1969-71 expect'- ^jrpected rates would tend to reduce any difference between higher .1 and expected cancers. .obserV"" f v- DSW 307431 On the'other hand, age-specific cancer mortality in New /as measured for the period 1950-69) was considerably Jersey* i han the national average; hence the expected levels in this higher ' ; uPW population probably should be higher than the national j New JO.?1* 7 * .. Ipv,-', The use of U.S. rates, rather than New Jersey rates Y incide//"^ . nd to -ncrease any difference between observed and expected, vould f,,n *' . #-hp llOVCVC' / / Jersey rates arc believed to be a reflection of . i j,,'r//J dilating expected incidence of cancer the rates used were **''%<> laf the '`total" (white and black) population because (D the *-. .ju distribution of the study population was not immediately r<i o **x * '1` '>](!, hn informed guess is that 0-1 of the 64 Research and \*-uncut cm.-loyecs and 2-3 of the 65 refinery employees .wore . .. ii i . i . % ii ______ i ,, ^ r ,.t. ~ ti p ;<( n9 i.iu; ivi . " . I STLCOPCB4069841 ' *.. .; ` . . . . occupational-environmental factors and therefore the Nov/ Jersey _ i population is a less desirable control group than the total U.S. population. . j- . The expected cancer rates were applied separately to exposure classes (a) and (b) yielding the expected numbers of cancers shown in Table E. * . . . '" ' -,,* L. 0 . ' DSW 307432 STLCOPCB4069842 f>JW~ULM ' . ' -' < * -+-+**rt*A* . . - . -. W*C*Vi <vrm'i--i m ytfrj+f~rf -Minif*nvm iiiirwt.uf.r* t.-i-- -r-***""" >.<-.--aw . *\ -O' *- . - . ^ **" 1 * tJ~' - ' * II. Data for Tho Refinery Plant: Employees . - h. Study group and exposure * *. 'i . Sixty-five employees at the Bead Plant in Paulsboro are reported as exposed to Arochlor 1254 for varying lengths of time during the interval between October 1953 and June 1958.. V7ith the exception of one individual listed as exposed for one month, all' exposures were from 6 to 56 months. ` - Of these 65 "exposed" men, 30 are still Mobil employees and 9* 35, including 3 deceased, have terminated employment (Table A).' Of these- 35, 11 had current medical records yielding a total of 41 men (30 plus 11) for the study population (Table D). For 12 men .(all terminated by 1960) no charts were available and for another 12 men charts are available only until the date of termination in 1961 or 19.62, Therefore these 24 men have been excluded from the analysis. '' It should be noted that no record was provided on extent of - . sxposure of Refinery Plant employees but only months of exposure, therefore no classification of this group was made in the analysis. 1. Observation period '' Observation time was calculated from the end of 1957 thru the nd of 1975 for the 41 men included in the analysis. * Expected number of new cancers , Person-years of observation and expected cancers were * alculated .as for the R and D employees (see Table E). JOI*'1 < STLCOPCB4069843 > 9 i Auj, i,,t ^k4.t^ULr.i..'. rr.i ' # . FINDINGS . The following is a resume of the preliminary analysis of this . data (Table E): '- ; I X. .Eight cancers'were observed in the total population versus 5.7 * expected. This difference is not statisticcillv significant. ' However, of the 8 cancers, 5 (62.5%) were either melanoma (3) . or cancer of the pancreas (2). This .compares with an expected percentage of about 5 percent of all cancers in the general *.. population. * ` '' *i . - - 2. One melanoma occurred among the refinery employees. The remaining tv;o melanomas and the two cancers of the pancreas occurred only among the 31 (60%) of the R & D employees who were listed as exposed to contact with Arochlor 1254. The percentages that these cancers are to all cancers found, as compared with expected percentages based on the general population,are highly ' significant (Table F) . . -. 3. Looking at the data for all study employees on a rate basis ' - . or risk of developing cancer (the preferred type of analysis), r 3 melanomas were observed versus only 0.1 expected, and 2 cancers ' of the pancreas observed versus only 0.2 expected (Table E). . For the R & D employees classified as "yes" to exposure to Arochlor 1254, the respective P values arc highly significant ' (Table <F)'. ' * . '. . "% DSW 307434 - ; STLCOPCB4069844  ",,' - . . Other f jridings: ' . - ^ * . 'i For the three cases of melanoma of skin the site location and age at diagnosis were as follows: right upper arm (57 years), upper lumbar region (51 years) and left anterior chest (42 years). Time from the data of first exposure to Arochlor 1254 \ \ to time of dicignosis for the three cases were: 10-14 years (calculated, exact duration not given in memo), 17 years, and 10 years, respectively. The two employees who developed cancer of the pancreas were ages .57 and 62 at the time of diagnosis. The times since first .exposure a were 13 years and 24 years. Both employees were non-smokers. . Carcinoma was also found in three other sites, among two R G D employees. Cancer of recto-sigmoid was diagnosed in a group (b) 4 . 56 year old employee approximately 21 years after exposure. Another employee in group (a) developed sarcoma of the right thigh at age 42 (14 years after exposure); ten years later he also developed multiple myeloma. :. - i i i 4 DSW 307435 STLCOPCB4069845 DISCUSSION AND LIMITATIONS OF THE DATA These findings, although preliminarv and excluding data On over one-third of the refinery workers and one-fifth of the R It D workers, suggest a probable causal relationship between exposure to Arochlor 1254 and melanoma. Even if all of the untraced pen in the "Yes" exposure group were found to have not had melanoma the P value would be virtually unchanged (P= .0015 instead of .0010). These findings are also coherent with biology (i.e. biological) Plausibility) . Chloracne is .known to be a freauent acute dermatitis ' occurring upon exposure to volatile chlorinated hydrocarbons (See literature review'.} In the Japanese women who ingested contaminated rice oil, both the women and their offpsring developed skin pigmenta tion. Histological examination of a stillborn fetus shewed a "marked hyperkeratosis... a marked increase of melanin pigments in the . basal cells of epidermis" (6). It should be pointed' out also that melanoma on unexposed portions of the body are relatively rare. . . As in the Japanese study, a dose-response gradient may be postulated as evidence of a causal relationship.. Although unverified, it is believed that the R & D group had a much higher exposure to Arochlor 1254 than did the refinery group. This is consistent with the larger number of cancers among the R & D men. ' The association of Arochlor 1254 with cancer of the pancreas is also statistically significant but weaker than that with melanoma. Furthermore, the possibility of cancer of the pancreas being asso 5? CO Q ciated with other chemical exposures in U f. D employees must be Considered. Li and Frnumeni in "Cancer .Mortality Among Chemists" (journal of the National Cancer Institute, November 19G9) reported an excess of deaths from cancers of the pancreas and lymphatic 30743q STLCOPCB4069846 I ' hro.chlor 1254 is no longer being uccd at Mobil but J?CJ3s arc , being- manufactured by Monsanto, are used in a number of . Industrial operations and have been dumped as a waste product into cater supplies. _ - ' If, as seems likely,PCB is a causative agent of melanoma, this cnowledge must be acted upon promptly. In terms of surveillance tor melanoma it should be noted that early diagnosis of this malignancy 1 greatly affects survival: Stage of Disease at Diagnosis localised regional Relative . Survival (%) * 5 yrs. 10 yrs. 73 67 33 32 Our data on a small cohort shows a very hiah relative risk of i 3eve3oping melanoma upon exposure to this PCB. 'This study should be replicated in other industrial settings where other persons have been jxposed to PCBs. The Japanese exposed to this agent in 1968 developed ikin pigmentation (as did their offspring) and chloracne. Probably n insufficient time has elapsed for cancer to develop in the Japanese i i f t r v cohorts but surveillance for melcinoma is essential. t ' ^ Survival from cancer of the oancreas is less likely to be affected i * >y early detection. . nevertheless, persons at high risk should be . identified: . . . Stage of Disease at diagnosis ' Localised Regional Relative Survival U) * 3 vrs. 5 vrs. 7A 22 J DSW 307437 -i Source: Knd Bcsults in Cancer, Hooort >10. <1 , NIII, 197?.. These are dative .survival rateswhich ad-just for "nornal" mortal! ty with ospoet to ago and oeriod of observation. | I STLCOPCB4069847 13 7\o stated, exposure to other chemicals may be implicated in cancer of 'the pancreas in particular. '' '_ *. Possibly other cancers may also be associated v/ith PCD. . Subseauent medical history of Paulsboro retired employees would be.important in this regard, also. Data for a larger employee population probably would be necessary for assessing the risk of other cancers, however. ' The major limitations of the data in our analysis should be mentioned: ' t 1. Data on duration,' age, and extent of exposure are limited. Also, . . no information is available on other chemical exposures. 2. No information is available on the occurrence of cancer in 37, . 1 or one fourth of all the employees in both groups. One or two missed diagnosed cancer cases of melanoma, pancreas, or other site could markedly affect conclusions. . 3. The number of observed cancers among men included in the analysis may v/ell be understated because there is no. reDorted follow-up (other than death) for those study employees who were terminated. This ; includes for R & D employees three living employees terminated five ! "' . ! to ten years ago and one 11 years ago. All are presently 69 years ,' Of age or older and therefore are in a high risk group for cancer in general. Similarly among the refinery employees information is ; leicking on several years of follow-up of recently retired employees. In effect, the methodology employed for all of these employees assumes i that no cancers developed amono them during- this period. ' , ' -. : '* . , ` . . ` * ' * ' DSW 307438 < l j --- . / . \ i *( t >1 STLCOPCB4069848 / 4, '4va*Y,,i>jA.U' 4--.;'. .V' t 14 .. ' ' * * I i .i * * * Another rna-jor limitation is the relatively-short observation . period. Induction of cancer due to small doses of this agent may require more than 20 years to manifest itself. Current information indicates that for environmentally induced cancers in adults, in general, the average latency period between first exposure and disease jls in the range of 10-30 years. j , Our methodology (observation period beginning in 1358)- under states the risk of cancer if there is a long latent period. For / example, if the minimum latent'period is ten years the entry period for the individual workers into the study cohort should begin at i varying times between 1959 and 1967 (or 1968) rather than in 1958. \ J STLCOPCB4069849 ;COMMnNPATIO:iS 15 *. .` i . 'i , Vie urgently recommend that steps be taken immediately to insure ." * < rompt arid periodic screening examinations for melanoma among all arrant!y employed and terminated employees (both R & D and refinery) ar whom there has been any possible exposure to PCD; i.e./all survi- ors of Vhe potential total of 129 men exposed. We also urge prompt Dvelopment and distribution of appropriate informational material or these employees. These recommendations are based upon (1) the /ata made available to us and our analyses (under the assumptions of ur statistical models) which show a highly significant statistical ssociation between "exposure" tor Arochlor 1254 and subsequent inci- !ence of melanoma (2) the biologically plausible relationship between i arochlor 1254 and melanoma in view of the freouency of reported chloracne lermatitis upon exposure to this agent and the Japanese study. Some .vidence for a dose-response relationship is also present. !. From' an epidemiologic standpoint it is also of high priority to !ollow-up the 37 men (former R & D and refinery employees) for whom :urrent records are not available to determine if they have had any :ancers, whether or not currently alive. The follow-up could be in :hc form of a general health questionnaire by mail, telephone, of . >crsonal interview. . Similar information should be obtained for 23 termincited employees who were included in the study but whose medical status for the last several years is unknown. . 1. The above recommendation addresses the oroblem of "missed cancers". In addition the epidemiologic studv needs.sharpening up with respect to exposure data (who were exposed; date's and. intensity of exposure- ** / ^ *;omc of this information is already avoidable in Dr. Meredith's records) << DSW 307440 i j i i j i l Itt i STLCOPCB4069850 1C I t .' , . * i. - ** so that the .appropriate classification of the employees by these parameters can be made'. Also, this information will assist in better n uantification of the dose-response relationship. ?herefore, we need to conduct a thorough epidemiologic study by obtaining xposure and other data via a questionnaire administered to all of ;he 64* R & D employees and 65 refinery employees (or the next of ( k iin, if dead) . Such auery would include also history of cancer - 5f any site (including squamous or basal cell carcinoma which might #, hot be known to medical records), chloracne dermatitis, liver disease, . md other significant medical conditions reauiring hospitalization; smoking history; family history of cancer;fair skin color; exposure to other chemicals. * i' . ' - rFor.this epidemiological study, in addition to the use of ' . ; I "internal" controls (the subgroup with minimal or. zero exposure) , it yould be desirable to have another control group such as a sample of \- ` other R & D or refinery workers and/or of other types of workers. ' t t ` This i. real j procedure would have the additional ` purpose of the study which if known advantage of "blinding" might introduce bias in the employee responses regarding intensity of PCB exposure. ' r 5. To`detect other possible cancers which may emerge, conduct in t . the near future, and' periodically, health screening examinations of I `>all exposed survivors (including retirees) for other |. other malignancies, and hepatic disease. i. A modified skin cancers, CAESCREEN iquostionnaire' and CAESCREEN examination might,achieve this and other . stated objectives. . ' :. DSW 307441 ,* Information on exposure-should be obtained not only by the . . employees reporting for themselves lull, also by requesting them to ` STLCOPCB4069851 >1 ... 17* i ` - .. i C. If indicated pcrfonn fat biopsies for PCD as one indication of extent of exposure. ' 7. If possible we would like to also study employees in other plants, such as Monsanto, where a larger number of emoloyees may have been exposed to PCD. . . I 8. Study MRDC employees on hydraulic fluid program. 307442 DSNN ii ii STLCOPCB4069852 '. # r o ; , #* STABLE a . .. ** * -. . Ymploycos by present status and by area of work: Area of Work R&D Refinery 'Total * 64 ' 65 Living At Paulsboro At Other nj ants Terminated Dead 32 ' 28 3 . 26 . 3(2) 1 2 32 3 2-29 ' 60 ROTE* Cancer deaths in parenthesis. 5 58 6 # OS'N A43 STLCOPCB4069853 19 Table B Medical Record Status of 64 Rescrirch f< `Development Employees * i Medical Bocords Available . ' 35 Current Employees ' Died while employed Terminated at ages 57 to 65 - presumably retirement* 51 Persons included in the analysis Mo Medical Records ' 13 Terminated or transferred 1362 or earlier: excluded . from the analysis. . 64 TOTAL ' ... . * The-earliest retirement was 1964; the second earliest was 1969. Half of the retired left in 1973 or later. . 0S**>7444 1' STLCOPCB4069854 Table C ' ' 20 ' i 'i Rating on Exposure to /`.rochlor 12 54 of G4 Research and Dovclopment Employees ** Rosinski Rating . . . .. Total - ,*> Low to High 64 29 Slight 12 Negligible,question able 10 No recollection 2 2'ero 11 ____Wilson Rati ncr ' (a) '. Yes * 38 26 .. 4 . (b) Other (Probable,Unlikely, Unknown) 26 3 8 / 6 `4 1 .1 1 10 Rating on Exposure.t o Aroc'nlor`1-2 5 4 of 51 Research and Development Employees included in t.'-ns stuev '(Excludes 13 no-rocords available employees) Rosinski Rating * . . . ' Wilson Rating ' (a) . .' Total Yes - (b) Other . (Probable, Unlikely, Unknown) ' bow to High 51 26 Slight 0 Negligible, question able 9 No recollection '~ Zero 8 approximate concordance of ratings OSIN M7445 -< i! STLCOPCB4069855 21 Tabic D .. Medical Record Status of 65 Refinery Employees 30 2 9 ___ 41 ' \ Current Medical Records Available Current Employees Died either while employed or within a year after .Terminated in 1967 or later (6 were ages 57 to 64 presumably retirement)-a majority left in 1971 or later. Included in the analysis No Current Medical Records . 1.2 No Medical Records - Terminated between 1955 and 1960. 12 Terminated in 1961-62 * ' 24 Excluded from the analysis * ' 65 * TOTAL iJ { DSW 307446 STLCOPCB4069856 tr d c G d 'd c d to V) d rH U O R ti 10 O PX A PI > .Q wo o -t o p<rH u' w 0c:: t4 s ii o a f-H Iti m-i d o G (3 Vc o o d d U I j u O i c> d d o H l) d ( (0 Cl M to d OU -i n :< a c R^ 0) x. jp o d G O d d d o c> 4-> U Q) P4/ to rj w CO w u d d P< CM H CO 9 .9 9 CM rH CO CM | o o O. o r-l j 9I CM | Hi to O. o o I l vr rH oo O H CM oo <U co cm in i CM rH CO CM t'' CM in 0) <u X. 4J o CM HI CO CJ t CO d d u H d G O d d i--I v0r-) d 0) > d CO dd CO Cl .Q Vl OO d RJ til *I CM I I CM t: CM I CM *H d tr H CO rH CO CvJ O rl {J CO H 4J d I CM -IJ co H-l O A ll Can 20 R 05 Jl o V to H 1 * rH - c vr in O CM 4->.H to 0) , 0) 0) Vl C) >< 0) Vi O :c ' J r-l o o. o (o .r. r-l :j r-l o o p, o 0, 0,0 fi n n N Vi M o 10 U/-: i 1 D. r: G) G * rH * O') # . s >< CO a to ^ ia <ii m *__* V> o: d o G Vi oi >1 .c; . 4 1 p, o in rs lO .0 co V--r d 0) G rH in >< ** n o i-l cn d 44 O JM 4J dd d o: r-l G to n. CM .-1 t" M vl- -- d C co to P, d o n 19 X mj o w l-i O fc CO rH o > CO Q) n rH d Jc 0) >i i d Im 0 CO n o 01 r-l Or X d Ec 01 ^ Cl . to n c; 4: * { ( i STLCOPCB4069857 23 + ` Tabic F Levels of Stat5stica1 fo cm i flea nee among grouR (a) (Yos) R & D employees *Pancreas *Melanoma _________________________P Values.' Observed number versus expected number As a percentage of all cancers observed compared to expected nercentaces .0025 . OIG^- .0010 .007 Assumes (1) that the data fit the Poisson distribution and (2) that there is independence of observations from year to year (this is not necessarily true of Person-year observations). I - I. *iip ' These P values are not based on tests of prior hypotheses but tests conducted after observation of the data. - ' .. '" . . . . . .. * . - , " . . * * ; i i (; i. * {* i ^ . ( .f, *. os***448 _. -- i ; i i STLCOPCB4069858 CERTIFICATE OF .SERVICE The foregoing Affidavit of Roscoe M. Moore, Jr., was sent by first-class mail, postage prepaid, or hand-doJivcrcd, this 3rd day of November, 1976, to: Ridgway M. Hall, Jr., Esquire Environmental Protection Agency ' Room 509 - West Tower 401 M Street, S. W. Washington, D. C. 20460 . Honorable Edward B. Finch Environmental Protection Agency . .401 M Street,. S. W. , Room 1019 Washington, D. C. 20460 . Ms. Khristine L. Hall Natural Resources Defense 917 15th Street, N. W. Washington, D. C. 20005' Council, Inc. Peter J. Nickles, Esq. Theodore J. Garrett, Esq. Steven S. Rosenthal, Esq. Covington & Burling 888 16tli Street, N. W. Washington, D. C. 20006 Michael K. Glenn, Esq. (American Paper Institute) Dunnington, Bartholow & Miller 161 East 42nd Street New York, New York 10017 ^ Philip H. Gitlen, Esq. New1 York State Department of Environmental Conservation 50 Wolf Road Albany, New York 12233 Roger C. Wills, Jr. Westinghouse Electric Corporation Westinghouse Building Gateway Center Pittsburgh, Pcnnsylvania 15222 ' 1 DSW 307449 STLCOPCB4069859