Document 2NjG0XyBj9RZkVdaEeBmVdVBb

% JAMES H. SSNGcfl Vtaa Preacfafg BJoniiarao Canyany 00 fi. Un&Big!\ fautmmri & Louis. U ia o u d 0 3 1 0 7 PiO TS: {314} * 3 7 3 October l, 1990 Mr. Donald Clay Assistant Administrator for Solid Waste and Emergency Response O ffice o f Solid Waste and Emergency Response U. S. Environmental Protection Agency Waterside Mall 401 M Street, .SW Washington* DC 20460 RE; Monsanto Company Sponsored Health Studies Dear Mr. Clay: Earlier this year* an EPA employee on your staff, acting in her private capacity but utilizing the format o f an intra-agency memoranda, forwarded to the EPA's Science Advisory Board accusa tions raised in an appellate brief filed in a private lawsuit involving Monsanto Company, The untrue allegations repeated in that memorandum referenced to two health studies sponsored by Monsanto to examine any impact o f possible exposure to dioxin in employees involved in the production o f herbicides at Monsanto's Kitro, West Virginia plant. The allegations charged that the"study results had deliberately under-reported cancer mortality. The gross inaccuracies o f these charges have been the subject o f prior correspondence to the Agency by m yself and by Monsanto's Chairman* Richard Mahoney. Notwithstanding our efforts to correct the record, these'baseless charges have been widely repeated in newspaper accounts and even before a Congressional Subcommittee where the charges were portrayed as fact, thus giving the incorrect impression that it is the government's view that the studies are misleading. Monsanto recognizes that the A gency did issue a corrective statement indicating that the employee was acting in her individual capacity, not as an Agency employee in preparing the memorandum* and.that her . memorandum does not reflect the Agency's official position. However, that statement has not remedied the problems caused by continual references to the accusations repeated in the memorandum which was prepared on Agency stationery. . In view o f the inability o f Monsanto to halt or correct the many erroneous reports with respect to these two studies and in view o f the extreme prejudice being suffered by Monsanto and the individual scientists associated with the studies, Monsanto is compelled to request, in the. strongest sense possible* that the U nited States Environmental Protection Agency, through the auspices o f NIOSH, perform a complete audit on the two mortality studies (authored by Zack/Suskind and Z ack/G affey) referenced within the memorandum. Monsanto is confident that the audit w ill confirm the conclusions reached by the original scientists: The impartial action urged herein would serve to put an end to this false controversy. Absent such government action. Monsanto w ill continue to suffer damage to its reputation. Given the Company's science-based focus, preservation o f Monsanto's reputation for performing accurate w orld-class research is o f critical importance to our business and research operations. Furthermore, since NIOSH is in the process o f issuing study results based, in part* upon the population involved in the two studies sponsored by Monsanto, it should be important for the governm ent to remove any stigma improperly attached to N IO Sffs work as a result o f the earlier charges raised against the predecessor studies. In connection with NIOSITi Dioxin Registry Program, Monsanto has previously furnished NIOSH with complete data sets regarding the mortality experience o f the Company's Nitro, West Virginia work force. It is believed that Dr. Marilyn Fingerhut at NIOSH has all the data necessary to perform an impartial, independent audit. If Monsanto can provide further assistance to facilitate completion o f an audit, via f urnishing any additional data, it would be happy to do so. I wish to stress that Monsanto believes the charges raised against the two studies are utterly without merit, but that Monsanto's own ability to counter these charges has been impaired by the incorrect impression created in the media that your Agency has challenged the validity o f these srudies. This erroneous impression is perhaps best resolved via direct government involvement in performing an independent audit o f the two studies followed with a publication by the govern ment in a peer-reviewed journal o f the results of-that audit. If you have other alternatives besides the suggested audit to respond to this situation, please feel free to contact my office. We look forward to receiving the commitment o f the government to proceed with this work. James H. Senger j Vice President * Environmental Policy Staff D F S :ddp/13 cc: Raymond C. Loehr, Ph.D. Chair, Executive Committee Science Advisory Board O ffice o f the Administrator U.S. Environmental Protection Agency Waterside Mall 402 M Street, SW Washington, DC 20460 Donald G. Barnes, Ph.D. Director, Science Advisory Board O ffice o f the Administrator U.S. Environmental Protection Agency Waterside Mall 402 M Street, SW Washington, DC 20460 Marilyn A. Fingerhut, Ph.D. C hief Industrywide Studies Branch NIOSH Robert A. T aft Laboratories 4676 Columbia Parkway Cincinnati, OH 45226-1998 excitement on the last day o f the meeting. Instead ot direct measures o f receptor bind ing, they used a handy surrogate; the in creased activity o f the cytochrome P-450 "hockey stick" curve, nor docs receptor bind ing necessarily imply a "safe" dose, says Silbcrgeld, who thinks her colleagues arc underestimating the intricacies o f receptor scientific community--and if it in f ia offers an advantage over the sums quo. "This is an improvement, not a cure-all," warns Lucicr. Once the model is complete, perhaps the enzyme system, widely considered the most rheory. Nor is she convinced " that the result biggest question, in tern o fdioxin's danger, sensitive response to dioxin in ail species. (of the new model] wilt be that different is the background exposure of the general No toxic effects arc known to occur at levels from EPA's current figure. As a scientist, I population, which comes chiefly from diet below those required for enzyme induction. object to the EPA model. But {its predic but also from environmental sources. Ifback- ^hcr reviewing dara on the necessary dose tions) may be very, very close, for totally grcHind exposure is comfortably below the for enzyme induction in ail species, Gallo, irrelevant reasons." practical "threshold" needed for receptor Birnbaum, Scheuplcin, and others took turns Working with EPA scientists, Gallo is activation (point 8 in the figure), then there at the blackboard, trying to calculate what now setting out to refine the risk number may indeed be a safe dose. But ifbackground the "safe" level in humans might be. Their for dioxin. George Lucicr and his colleagues .exposure is higher, near the "threshold" rough, back-of-the-envelope calculation; 1 at N1EHS are doing the same. The idea is to (point A), "then there is no margin for ad to 3 piengrams per kilogram per day--several build a conceptual model o f cellular re ditional exposure," says Moore. Background hundred times higher than current U.S. sponses to dioxin and then turn that over to exposure is now estimated to be about I standards and in the same ballpark as those mathematicians to develop a predictive ukjI picogram per kilogram per day--slightly be set by some European countries, which ar to estimate dioxin's risks-- not just for low the rough "sale" number the Banbury rived there by an entirely different method. cancer bur for any toxic endpoint. William group came up with--which may not leave Not so fast, say's Maryland's SilhergclJ, Farland, who runs the dioxin risk assessment much room tor additional exposure. who cautions against "replacing one stupid effort at EPA, expects a "straw man" model At this juncture. EPA officials are enthusi model wirh another." fo r one, a reccpror- to be complete n jbout a year. The next step astically embracing the new scientific ap based model does not necessarily predict a would be to see if it passes muster with the proach. Don Barnes, a dioxin expert and executive director of EPA's Scientific Advi sory' Board, talks o f "a real breakthrough, a Monsanto Studies Under Fire sea change in our sicw ofdioxin." In fret, the topic is deemed important enough that a special briefing is planned for EPA adminis The Environmental Protection Agency has launched a criminal investigation to trator William Reilly and top agency officials. determine whether Monsanto Corp. o f St. Louis falsified three epidemiologic studies But how frr is EPA likely to go if the o f its workers, which showed no increased health risks from dioxin other than the skin modeling exercise docs reveal that dioxin is disease chloracne. The investigation, which EPA is rjiandated to conduct in response less risky than rhe agencies now calculate? to a petition requesting it from the activist group Greenpeace USA, should resolve, Gough of OTA, for one, thinks that the once and for all, the allegations that have been swirling around diese studies for answer is not very fan "Dioxin is the most almost a year. EPA officials would not confirm or deny the existence o f the potent carcinogen ever tesred. If they back investigation, but Science obtained internal agency memos discussing it. o tf this one, they will open the door to every The EPA has not notified Monsanto that it is under investigation, but says Dan chemical manufacturer in the world" whose Bishop, the company's director o f communications, "We hope there is one, we chemical acts in the same way. "That is a welcome it. It is the only way to put this martcr to rest." In fact, the company wrote door they will reluctantly open." Gallo-con to EPA twice over the past few months, begging the agency to perform a scientific tends that the door will open just a crack, as audit o f the studies. Bishop calls the fraud allegations "bald-faced lies." there are less than a dozen carcinogens The main charges are that Monsanto epidemiologists misclassificd exposed work known ro work the way dioxin does. And he ers as unexposed in their control group and that they omitted workers who,had died predicts that the new receptor-based risk o f two cancers that have been linked to dioxin exposure in other epidemiologic model will cut both ways; some carcinogens studies. T he charges first came to lighr last February when a plantifTs lawyer in will turn out to be far riskier than now- Kem ner v. M onsanto, a case involving a tank-car accident, reviewed the studies, predicted; others, like dioxin, less risky. decided they were fraudulent, and alerted the press to the alleged cover-up. That brought in Greenpeace, and also Cate Jenkins, a chemist in EPA'sregulatory branch. Moore agrees that change will not be easy. "For issues this emotional, you have to She has since made the Monsanto studies something ofa personal crusade, petitioning EPA's Science Advisory Board to audit these and other studies, and meanwhile be purer, than Caesar's wife anytime you propose to change the status quo. There sending numerous copies o f her memos to various environmental groups, Vietnam would have to be a fair degree of support veterans organizations, and her friends on Capitol Hill. Jenkins maintains that within the scientific community for it to M onsanto's studies have directly affected how EPA regulates dioxin. O ther agency come to pass, especially if the potential officials deny that, saying that EPA's current--and very stringent--standard for change is a `relaxing' of the number." dioxin exposure a based on animal studies. Eric Bretthauer, EPA's assistant adminis Everyone Science spoke with who is familiar with the Monsanto studies agrees that trator for research and development, con they arc flawed, but probably not as the result o f criminal intent. The scientific cedes th jt "the agency hasn't traditionally questions about the studies may now be moot, however, as all but six o f the relaxed numbers." But, he says, "I think' M onsanto workers in the three .studies have been carefully reexamined as part o f a there is a willingness at the policy level to larger federal study just published, which suggests due high dioxin doses can'Xause take it on. My view is we have to be open to human cancer (see box on page 62S). The other questions may be tougher to resolve. changes in science, whatever their effect on When EPA completes its investigation, the agency will report to the Justice D e regulatory policy." He adds, however, that partm ent and recommend either that they prosecute or dose the case. L J L " the science has ro be very clear." Leslie Roberts 626 SCIEN CE, VOL. 251 Nitro Plant Update (2,4,5-T dioxins) To provide perspective, Monsanto iniated in mid-1978 a joint epidemiology study of employees and former employees of our Nitro plant in conjunction with Dr. Raymond Suskind, Institute of Environmental Health, University of Cincinnati. This study' involves workers exposed to dioxins (unknown at -the time) released in a 1949 trichlorophenol accident at the plant, and subsequently in 2,4,5-T associated departments up to 1969 when Monsanto ceased production. Over 120 people involved with the 1949 accident, and over 150 people in the subsequent 1949-69 period developed chlor- ,acne .(including some with additional symptoms). In most cases, with treatment,' symptoms disappeared over time. -* Dr. Suskind, a consulting dermatologist who had treated over 35 of our more severe Nitro cases in the 1949-- 55 period, subsequently became involved as consultant to the World Health Organization in. the investigation of other dioxin accidents, including the major 1976 Hoffman-LaRoche release in Seveso, Italy, involving over 1200 people. Additional controversy has occurred over the Agent Orange-.; (containing dioxin impurities) exposures of veterans said civilians in Viet Nam, and the recent banning of 2,4,5-T following the alleged excess ^abortions from forest spraying in Oregon.^-. In the interim, animal toxicology has implicated minute concentrations of *dioxins (2,3,7,8-Tetrachlor) in severe toxic, effects,. both acute and chronic.(reproduction, cancer, etc.) in several species.V. Thus, the .Monsanto population exposed up to 30 years previously to dioxins . became of significant worldwide interest in attempting to answer . questions about the long-term health effects, if any,' of dioxin*: . : ' : exposure. -rVi ./ \ 1 * ' 'While implementing our study of mortality experience at. N i t r o . as an -- ^ initial-step in identifying involved employees and potential health , problems, the Steel Workers Union announced a health study to be': / conducted by/Dr. Selikoff of Mt. Sinai Hospital', New York, on April'' 6-8, 1979.; yin response to the potential allegations which could ... . v^, . result-from the Selikoff volunteer health examinations,- we moved ^ forward-as rapidly as Dr. Suskind's schedule permitted with a ' V: : v hands-on Monsanto-funded health study which was carried out successfully : at*Nitro, June 11-18. A total of 437 people were examined by Dr. .v>/ Suskind's staff which represents an increase of 70% over the number * (260) examined b y ;Dr. Selikoff i n 'April. We believe that Dr. Selikoff's . study results may be completed for reporting in late July, while. * Suskind's results (we believe to be more complete and thorough) will not be available until Fall. In the meantime, we are vulnerable.::, to Selikoff announcements and/or allegations of potential health problem^ which he may relate to dioxins or to other products such as rubber chemicals, PAB, etc. which are/have been produced a t .the sNitro plant., ... .- ' .- Currently, DMEH has major effort in analyzing the mortality data from the 1 9 4 9 -accident group and the 1976^78 medical data (clinical "and medical histories) for active hourly employees,,to determine if any significant relationships exist between abnormal past findings : nd 2,4,5-T (dioxin) associated exposure. We expect the results rom this computerized analysis will help us anticipate potential T 'TV; 11J. LJ. U f a n c u p u d c e ,J u l y 9 1979 P a g e ?.. . v -. . ~ .;/ health problems, and be responsive in evaluating results of" ^ Selikoff's study which may appear as allegations or announce- ? ` raents, prior to the Suskind results later in the year. The * ..first mortality results of our 1949 accident group do not indicate yri'-.'any statistically significant changes from U.S. mortality experience ^ W h i l e this riegative.preliminary result is encouraging and may help ; allay anxiety of employees, we cannot be confident of overall health conditions until both the complete mortality experience and current health studies are completed. _ s'.- ; v - . * F.. Meyer .. . . -v/. , 'n'*" . - ' *y. ' *i v?\ yK ' Willi J. McCarville - AJNC - 4-3237 August 11, 1976 Mr. P. S. Park, Dr. George Roush Hr. J. R. Sayers T O * M r . R. W. Duesenberg Mr. J. R. Eck Mr. F. J. Fitzgerald Dr. S. A. Heiningex Mr. J. T. Solan Mr. W. L. lading Mr. T. K. Smith Jr. Mr. M. C. Throdahl 1. Action Section A. Problea/Issue/Sltustlon In 19A9 a process accident la a trichlorophenol auto clave at Rltro exposed a number of our employees to the chemical tetrachlorodibenzodloxin. commonly known as TCDD or "dioxin*1. The immediate effect vas a skin disorder, chloracnc. Two hundred twenty-eight employee* vers treated by four Charleston, V. Va., dermatologists. Thirty-seven of these employees were subsequently referred over tbs period 1949-53 to Dr. Raymond Sussklnd, a consulting dermatologist at the University of Cincinnati. ^Dioxin** has been alleged to have caused a whole spectrum of health effects as a result of its being a contaminant In tha harbieida 2,4,5-T widely used in Viet Ham as part of a defoliant mixture called Agen. Orange. It also received further adverse publicity as e result of an accident, similar to our Nitro experienca, at Seveso, Italy, in 1976 where more than 5000 persons ere known to have been exposed. Dr. Sussklnd hat approached Monsanto with e request to do e retrospective epidemiologic study on the 37 employees be examined in order to predict whether those people who were exposed et Seveso face chronic health risks in the future. 8323844 76 B. Beconincndatlona It Is recocraendad that vt do an epidemiologic study of exposed Ultra personnel In cooperation with Dr. Sussklnd. The group studied should Involve as cany of the 226 exposed . p l o y s a s as we can locate, since the 3/ Identified by Dr. Sussklnd would be too small a group from which to obtain meaningful results and could have a large Inherent bias as the referral to Dr. Sussklnd might Imply that the 37 were among the mora serious cases of exposure, - A substantial effort will be required to accomplish this study. Ve further recocsaend that we engage outside consul tants to avoid dilution of ongoing studies directed to determining the possible risk to our employees of current exposures to substances such as acrylonitrile, styrene monomer end benzene. The study would remain in the overall control of Monsanto; Dr. Sussklnd, while he may be part of the consulting team, would not be in charge of the effort. 2. Background Section The Law Department has advisad us that there is no legal require ment to carry out this study. Further they have advised that ve should recognize that any effort to obtain information concerning the health status of employees exposed In the 1949 Incident may tend to relate the exposure to present health problems. The Vest Virginia statute of limitations requires that action for Injury or daasga be brought within two years of the exposure, but claims for wrongful death can be brought within two years of death regardless of when the causal event took place. In Vest Virginia there is no limitation on the amount of recovery which might be obtained in such a lawsuit. nevertheless, a voluntary, Honsanto-sponaored follow-up study it consistent with our policy of social responsibility and could contribute significantly to beneficial or avan life protecting measures and treatment for our own Involved employees end for the people involved at Seveso in the event long-term effects ere discovered, or if none ere discovered, the population at Seveso could be reassured. w, > *" /hmv 83258*5