Document jyYnwopvmxV6p9NJ1Zp5ejrvQ

M X //7 MONSANTO BIOHAZARDS COMMITTEE Minutes of a Meeting October 4, 1979 Those present were Drs. George Roush and William McCarville, Monsanto? Dr. Marvin Kuschner, School of Medicine, State Univer sity of New York at Stonybrook; Dr. Robert Neal, Vanderbilt Uni versity School of Medicine? and Dr. Robert E. Olson, St. Louis University School of Medicine. The meeting was called to order at 9:00 A.M.**' The first item on the agenda was a report by Dr. Ward on the present status of the analysis of dioxins from samples taken from spills or residues at the Krummrich plant. By combination of gas chromatography and mass spectrometry, the Monsanto facility at Dayton, Ohio has been able to obtain reasonable results on mixed tetrachlordibenzodioxins (TCDD) derived from 2,4-dichlorophenol which was the main product in the spill. The present resolving power*of GLC in that facility does not distinguish between the various isomers of TCDD, the 2,3, 7,8-tetrachlorodibenzodioxin being the most toxic. The recovery of total isomers seemed reasonable in the range of 100-600 parts per billion (ppb) . It was urged--that capillary GLC be established and interfaced with the mass spectrometer in order to more properly distinguish the isomers. Dr. B. Ward presented this data. Miss Judy Zak, of the Monsanto Company, and Dr. Suskind, Dir ector of the Institution of Environmental Health, University of Cincinnati, have submitted a paper to the Journal of Occupational Medicine titled "The Mortality Experience of Workers exposed to Tetra chlorodibenzodioxins in a Trichlorophenol manufacturing Acciden" at Monsanto1s Nitro West Virginia plant. One hundred twenty-one workers who developed chloracne resulting from this accident on March 8, 1949 were selected for study. The relative risk for all cause of death was shown to be 0.69 with 32 deaths observed and 46.4.expected. With the categories of malignant neoplasam and circulatory disease the relative risks were 1 and 0.68. Although the cohert is small and the number of deaths also, small, it appeared there was no apparent excess in total mortality or in deaths from malignant neoplasms or diseases of the circulatory system in this group of workers followed for nearly 30 years. Dr. McCarville then presented some American Industrial Health Council comments on a report of the -Inter-agency Regulatory Liason Group (IRLG) on risk assessment entitled "Scientific Basis for Identification of Potential Carcinogen and Estimation of Risks." The American Industrial Health Council stressed the point that scientific and social considerations should be distinguished in developing regulatory procedures. The Committee felt that it is intrinsically difficult to ask a regulatory agency not to engage in any scientific considerations in determining what substances seem likely to be carcinogenic, and then to collect and review data. C03120 ) Two other items were presented. A report by Paul Deisler, vice president of Health and Safety Environment of the Shell Oil Company, suggesting a mathematical model for cancer risk assesment and reduction, was considered a useful model for further study. Finally, Dr. McCarville presented the "Report to the President by the Toxic Substance Strategy Committee" dated August 1979,(Speth Report) which is presently in the Federal Register for comment by October 15th. This document was considered by all members of the Committee to contain many inaccuracies. The paper is not balanced and does not stress evolution of criteria for investigating sus pected human carcinogens and quantitating risk-benefit.. It is in flammatory in the sense that it exaggerates the morbidity and mor tality arising from industrial exposures and'adheres to a very rigid Delaney-based standard for determining the human carcinogenicity of chemicals. i * i Dr. B.W. Karrh, Medical Director of th DuPont Company, sub mitted his final report "Epidemiological Study of Workers Exposed to Acrylonitrile" to EPA and it was made available to Monsanto. A 98% follow-up of a cohert of 475 former employees exposed to acry lonitrile was made. It was discovered,,that 89 deaths at Camden, South Carolina had occurred in this group between 1957-1976, of which 25 were cancer deaths-. These persons succumbed from a variety of tumors:- 8 lung, 3 colon, 3 prostate, 2 bladder and 1 each of thyroid, nasopharynx, penis, esophagus, brain, leukemia, lympho sarcoma, Hodgkins, and malignant melanoma. The different distribu tion of these causes-of death were not significant from that expected. A slight excess of cancer deaths was found when only compared with the DuPont controls but not the U.S. death rate or even that of sur rounding counties in South Carolina. On the basis of this study, the question was asked the committee, "What should Monsanto tell their employees?" It was concluded they should tell them that acry lonitrile causes cancer in animals, that the environment in the Monsanto acrylonitrile manufacturing plants is at the very low level of 2 p.p.m. in conformity with the standards of OSHA, and that there is no conclusive evidence that this compound at this level causes cancer in humans. Dr. Roush reported the present status of the hypersensitivity pheumonitls problems at the Pensacola plant. He has engaged the services of Dr. Jordan Fink, from the Medical College of Wisconsin in Milwaukee, to 1) carry out a clinical laboratory study involving the evaluation of pulmonary function-, in employees with circulatory anitbodies to air-conditioner residue antigens, 2) to discover whether an immunologic challenge to provoke a change in pulmonary function can be developed and 3) to monitor any changes in anti body levels. Dr. Roush also reported that the Environmental Health Labora tory (EHL) is going to be expanded to include additional space to expand research opportunities which will be in agreement with com pany goals in the testing of chemicals. The committee was asked 9% to provide suggestions for areas for research and new technologies which might be developed. It was agreed that the short-term tests should be extended to include cultured human cells to determine how this system correlates with other-short-term tests and with responses in animals. Studies of metabolic differences between human and other cells that might provide a clue to the interspecies variation in carcinogenicity was urged. Finally it was recommended that studies of neurotoxicity of chemicals be expanded. Dr. Roger Falk, of the Battelle Institute, has been appointed Director of the-EHL. He has been on site for three weeks and ap pears to be. a competent and congenial man. 1 . - n ~ * >'. Finally, Dr. George Levinskas asked for ..comments on the recent statement in the Federal Register regarding the Toxic Substance Con trol Act which requires any person who intends to manufacture or im port a new chemical substance to submit a premanufacture notice to EPA at least 90 days before manufacture or.'import. The question is "What should be submitted?" The only requirement appears to be that .one submit 'what is available with respect *ta 'physical state, chemical properties and health or ecologic effects of the agent. Dr. Levins kas asked "What is the minimum battery of tests to be spplied to such new chemicals?" It was the opinion of the Committee that it was hard `to give advice without finite examples. It was suggested that Dr.-Levinskas provide us with a list of ten chemicals that might be prioritized in terms of potency, type of danger / -degree of danger, type of exposure and amount of exposure to workers in the plant and possible long-term consequences. After some discussion of the Toxicology budget for 1980, the meeting was adjourned at 3:30 P.M. The next meeting of the Biohazards Committee will take place on November 12, 1979. '^ BIOHAZARDS COMMITTEE MEETIN ______ October 4, 1979___ A 0 1- DIOXINS - ANALYSIS KRUMMRICH STUDY - SUSKIND NITRO hin HA - CHICAGO. MEETING FOR PRESS *' * 'f 3.. AIHC - COMMENTS OF IRLG SPETH REPORT SHELL APPROACH ti A 4A duPONT ACRYLONITRILE STUDY STATEMENT TO EMPLOYEES 5. PENSACOLA STUD 6. EHL EXPANSION -v 7 ^ PMN, TIER TESTING, AND- CHEHIAL ' TREES B. WARD G. 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D&P Ru b b e r SCD 370 250 890 504 Total 3447 246 312 170 65 3755 242 2915 450 '3607 ZoX TZU.91M. -*-MTC AND MP&R HAVE NOT INDICATED SPECIFIC NEEDS GENERALLY, THEY DO RELATIVELY SMALL AMOUNTS OF TESTING. Th r e s h o l d On g oi n g s t u d i e s + 1/2 New studies In c r e m e n t CL ; (5,500, XC6 1 t/O To^ CITO *2*(p <SVTJ( 1/2 New s t u d i e s + 1/3 In c r e m e n t a l (3;000) In c r e m e n t .3 * 1/5 In c r e m e n t a l \ ( 750) Pr e l i m i n a r y Proje c t i o ns Anticipated Budgeting (10^809) ( 9,250)