Document kDOgy116d8V5vD0m49L8EZ6vV

k NS SL' Ni J -C T ililp J SUBJECT TO PROTECTIVE ORDER. News BackgrounderMonsanto MARCH 17, 1980 MONSANTO COMPANY l ST. LOUIS, MO. Agent O range. . . W hat are the facts? G04508 Monsanto Company Perspective Monsanto is involved in numerous lawsuits over its role as one of the companies that supplied the defoliant "Agent Orange" to the U.S. military during the Vietnam War. The company is often asked where it stands on this highly charged, emotional issue. Simply stated, it is Monsanto's position that the avail able scientific an'd medical evidence does not support the claims of adverse health effects alleged in the lawsuits. This White Paper discusses the subject in considerable detail. For more information contact D. R. Bishop, Director, Environ mental Communications, Monsanto Company, 800 N. Lind bergh Blvd., St. Louis, Mo. 63166. Telephone: (314) 694-2891. Background ``Agent Orange" was a U.S. Government code name for one of a number of herbi cide mixtures used by the U.S. military during the Vietnam War to strip trees and brush of their foliage, thereby deny ing the enemy cover and concealment. Agent Orange has become a highly emo tional public issue in recent months as a result of charges made by various Viet nam veterans' organizations alleging that many servicemen and their families are suffering adverse health effects from - exposure to Agent Orange while 'in Vietnam. Lawsuits filed on behalf of Vietnam veterans against companies that produced Agent Orange for the U.S. Government seek to create a special trust fund, ad ministered by the courts and financed by Agent Orange producers, to compensate the alleged victims. Monsanto Company of St. Louis, Mo., was one of the companies that produced Agent Orange for the U. S. Government, and is one of the defendants in these suits. What Are The Facts? The principal ingredients of Agent Orange are two phenoxy herbicides, 2,4-D and 2,4,5-T. The concern is with the 2,4,5-T which can contain miniscule amounts of the toxic chemical 2,3,7-8 tetra-chlorodibenzo-p-dioxin (or TCDD). This unwanted contaminant is but one of some 72 compounds which together form a family of toxic chemical impurities commonly referred to by the news media as "dioxin." While it is technically incor rect to use the generic term dioxin when referring to a specific compound like TCDD, we will do so in this paper for the sake of brevity. Dioxin can be formed in ultra-trace quantities during the manufac ture of tri-chloro-phenol, which is used to jiake 2,4,5-T. The Agent Orange contro- jrsy centers on dioxin, which is extreme- toxic to some laboratory animals, less toxic to others, and of unknown toxicity to humans. The herbicides 2,4-D and 2,4,5-T, have been used for nearly 40 years in this country and abroad for crop protection and forest and range management. Their efficacy and economic benefits in control ling weeds and underbrush are well documented. They are registered under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and their use is currently regulated by the U.S. Environmental Pro tection Agency (EPA), Registration requires producers to in clude on all labels certain basic informa tion, including the chemical makeup of the formulations,, recommended applica tion rates, and all appropriate cautions and warnings, Monsanto Involvement Monsanto Company manufactured 2,4,5-T at its Nitro, W.Va., plant from 1948 until 1969 and made 2,4-D at its William G. Krummrich Plant in Sauget, 111., (near East St. Louis) from 1946 until 1970. At various times between approx imately 1963 and 1969 Monsanto was asked to provide quantities of a specially formulated mixture of 2,4,5-T and 2,4-D to the U.S. Government. The only mark ings Monsanto was permitted to place on the containers, according to the contract, were a contract number, a batch number and an orange-colored band--thus the name "Agent Orange." Under further terms of the contract, the government took title and possession of the material at our plant. It, in turn, shipped the material within and outside the U S under government bills of lading. Since Monsanto had no registered label for ft:- -pecific mixture, the company would nj\ e been in violation of FI FRA r e g u i . i h a d it attempted to ship Agent *r.inge in interstate commerce. M-r.-jiuo was not a basic producer of the mw material, tetra-chloro-benzene, which .> u-ed as a starting point in the manuf.H lure of 2.4.5-T. During the Viet nam \^ar this raw material and others were classified as government priority items In order to get raw materials in this classification, purchasers were re quired tu obtain "certificates of necessitv from the government. Thus, Monsanto was permitted to purchase only specific quantities of tetrachlorobenzene needed to fulfill its government contracts for Agent Orange. During this period, Monsanto was forced to surrender its share of the com mercial 2,4,5-T market to competitors who were basic in the raw material. As the war wound down, the company elected, for economic reasons, to shut down the 2,4,5-T unit and get out of the business. Human Health Effects From Herbicidal Exposure The EPA issued an emergency suspension order in March of 1979, preventing some further uses of the herbicide 2,4,5-T. Highly questionable findings from a study which reported an increased number of spontaneous abortions among Oregon women, referred to as the "Alsea II Study," formed the basis for the suspen sion order. This study was subsequently discredited by no less than five indepen dent scientific groups.*" *11 In the fall of 1979, EPA's own inde pendent scientific advisory panel advised against banning the remaining uses of the herbicide, citing a lack of evidence Unking exposure to adverse human health or en vironmental effects,*4' The long history of safe use of 2,4,5-T suggests that the diox in contaminant in the herbicide is well below levels considered potentially hazar dous to humans or other living organisms.*7' Simply stated, the available scientific and medical evidence does not support the claims alleged in the veterans lawsuits. This evidence include the following: A 1974 report issued by the. National Academy of Sciences**' which concluded that there was no evidence of a-sin1tation between exposure to Agent ( >ran*;e and human health problems. The major constituents of w m Orange--2,4-D and 2,4,5-T --has e been the subjects of more than 40.000 -vi.-nufic papers and technical article- " ut :he past 35 years.**' These studies p-p'-atnilv con cluded that the phenoxy hrr*-. de- are not significantly hazardous to humans or animals under normal and recommended conditions of use. Both the Veterans Administration and the EPA have stated publicly and repeat edly that they have found no long-term health hazard related to exposure to Agent Orange.,,0, A series of independent workshops sponsored by the American Farm Bureau to reach an unbiased scientific opinion about the human health effects of ex posure to 2.4.5-T announced their findings in June of 1979.1" ' They reported: 1) "No adverse effects on human repro duction have been observed after expo sure to 2,4,5-T or TCDD," and 2) "No evidence (has been found) indicat ing 2.4.5-T, TCDD or any phenoxyacetic acid herbicide are human carcinogens." Industrial Accidents Involving Exposure To Dioxin Information on acute and chronic toxicity to humans is being gathered from detailed epidemiology studies of populations ex posed to dioxin as a result of industrial accidents. The two most significant and most extensively studied occurred in Seveso, Italy, and Nitro, W. Va. Seveso, Italy, July, 1976 The most recent and massive human exposure occurred in Seveso, Italy. An ex plosion at a chemical plant there spread dioxin--as a contaminant of the chemical tri-chloro-phenol--over several hundred acres near the plant. Estimates as to just how much dioxin was dispersed center on several kilograms. Based on projections of acute toxicity from animal studies, the release of several kilograms should have killed every human being within miles. Indeed, much was written following the Seveso incident forecasting doom and horror of this mag nitude. But only the reports of adverse health effects to date are cases of chloracne'111 (a skin condition commonly associated with exposure to dioxin). Thus, it appears that dioxin on an acute (short term) basis is much less toxic to humans than to most species of laboratory animals. While some researchers classify diox in as an animal teratogen (a material that causes birth abnormalities), the human ex perience at Seveso so far has not proved this. Extensive data from Italian health officials and the World Health Organiza tion (WHO) gave absolutely no indication of increases in birth defects, abortions, or other teratogenic effects that could be correlated with the Seveso exposure.11" Nitro, W.Va.--March, 1949 The first recorded incident of dioxin expo sure to a relatively large population oc curred during a similar but much smaller industrial accident at Monsanto Com pany's Nitro, W.Va., manufacturing plant. On March 8 of that year, about six months after production start-up, a vio lent reaction occurred when temperature and pressure became excessive within an autoclave (pressure vessel). A relief valve opened, discharging fumes and residue from the autoclave into the atmosphere and into the interior of the building. Some 121 employees who either worked in the area or were subsequently involved in the cleanup immediately be gan to develop symptoms now associated with exposure to dioxin. These symptoms included chloracne, eye and respiratory tract irritation, headache, dizziness, nausea, muscle discomfort and liver disorder. All symptoms--except some cases of residual chloracne--gradually disappeared. Nitro Mortality Experience A standardized mortality analysis (study of the cause of death) was recently con ducted on the 32 workers (from this group of 121) who have since died from any and all causes. This medical study, co authored by Judith A. Zack, a Monsanto epidemiologist, and Raymond R. Suskind, M.D.. a recognized expert on the health effects of exposure to dioxin and Director of the Institute of Environmental Health at the University of Cincinnati Medical Center, was published in the January, 1980 issue of The Journal of Occupational Medicine (volume 22, No. 1. pp. 11*14). It is the first long-term study of a group of workers known to have been exposed to relatively high levels of dioxin. The study found no apparent excess in deaths from cancer or cardiovascular disease based on standard cause of death statistics for the U.S. population as a whole. The study also concluded that the 32 deaths were less than would be expected, based on standard U.S. death rate statistics. The Nitro Plant mortality analysis has provided important, definitive infor mation on the probability of long-term human health effects from exposure to dioxin. All 121 people who suffered acute effects as a result of the incident were successfully traced through records, thus a complete follow-up was achieved. Acute health effects of dioxin expo sure are described in the literature, but until now little has been known regarding chronic lor long-term) effects. Thus, the Nitro analysis is particularly significant in that it uncovered no apparent excess of total deaths or deaths from major chronic diseases 'cancer or circulatory system) in a controlled and we11-identified group of worker* known to have experienced a high pe.iK exposure to dioxin and then tracki-ii ,.r a period of nearly 30 years. Nitru Kpidcmiology Study Alioii.-'-, - -..me 400 Monsanto employees work.-.: - J.4,5-T production unit (and thu- r- -'inned to have been exposed to - .! dioxin) at one time or an>':*' j che 21 years that the .V" mufactured this herbicide. rucne. no adverse long- irr.- i is have been observed in thi- * rkers on the basis of regi.. i- ..rveillance and medical mom: * . . - d im s in effect at this and all : -.into locations. 1 - * rn-tanding, in mid-1978 Mon-.i- - '. d to fund a second health stud> i -r\ ihorough epidemiology studv -* ... l"rmer 2.4.5-T workers for \erv 'p.'i 11ic reasons: First, we felt we owed our employees and ourselves the most complete health evaluation possible using modem medi cal techniques. Second, this Nitro Plant work group, exposed to 2,4,5-T for sustained periods of time 10 to 30 years ago, represented the best opportunity thus far, anywhere in the world, to study the chronic effects, if any, of exposure to dioxin. Third, in view of the growing world wide concern regarding potential human health effects of exposure to dioxin-- fueled by the industrial accident in Seveso. and more recently the Agent Orange controversy--we felt this study could provide meaningful medical conclu sions to ease the anxieties of those who may have been exposed to dioxin and now fear the worst. This health study is being adminis tered, controlled and conducted by Dr. Suskind and his medical team from the University of Cincinnati. We expect it to be completed in the spring of 1980. After review by and publication in an appropriate medical journal, the results will be made available to the public at the earliest possible date. References Cited 1. Lamm, S.H. 1979. A n epidemiologic assess ment of the Alsea I I Report. Paper submitted to the FIFRA Scientific Advisory Panel, U.S. Environmental Protection Agency. Tabershaw Occupational Medicine Associates, Rockville, Maryland. 2. Mantel, N. 1979. An evaluation of the statistical methods used in EPA's "Report of assessment of a field investigation of six-year spontaneous abortion rates in three Oregon areas in relation to forest 2,4,5-T spray prac tices" (the Alsea II Report). Paper submitted to the FIFRA Scientific Advisory Panel, U.S. Environmental Protection Agency. George Washington University, Washington, D.C. 3. Newton, M. 1979. Letter to Congressman Les A u Coin, March 15, 1979. School of Forestry, Oregon State University, Corvallis. 4. Smith, A.H. 1979. Seasonal analysis of Oregon data on spontaneous abortions and 2,4.5-T spraying. Paper presented at Annual Conference, New Zealand Branch. ANZSERCH, Dunedin, New Zealand August 1979. Wellington Clinical School of Medicine, Wellington, New Zealand 5. Wagner, S.L., J.M. Witt, L.A. Norris, J.E. Higgins, A. Agresti, and M. Ortiz. Jr. 1979. A scientific critique of the EPA Alsea II study and report Environmental Health Sciences Center, Oregon State University. Corvallis. 6. Toxic Materials News, Sept. 25 1979. p. 306. 7. Council for Agricultural Science and Technology, Aug., 1978. The Phenoxy Herbi cides, Second Edition, Report No. 77. p. 22. 8. Committee on the effects of herbicide1*tn South Vietnam, 1974. Part A. Summum and Conclusions, National Academy 'iri's. Wash. D.C., 398 pp. 9. Council for Agricultural Science ;n.t Technology, Aug., 1978. The Phrn <i -. H.'-birides. Second Edition, Report ,V-> 77 :< .W 10. Art'Kaufman, Clobe-Democrtt.M ;. i< writer. S t Louis Globe-Democrat V ." t * 1979, p. 1. 11. Toxic Materials News, June ***' : 188. 12 < 13. Chemical < Engineering \ . . - Magazine, Feb. 12, 1979. Amen- ri Society, Wash., D.C., p. 25.