Document eLqeqDdnov7YZL5mB1pvnLjM

% SAL 000103255 - 6 2 7 C VINYL CHLORIDE HEALTH I I B.F. Goodrich Loses VCM Cancer-Link Case A Federal district court in Camden, N.J. has ordered B.F. Goodrich Com RECEIVED pany to pay almost $400,000 in compen satory damages to a New Jersey FEB * 3 1981 woman whose husband's death was linked to emissions of vinyl chloride gas from Goodrich's Pedricktown, N.J., polyvinyl chloride plant. Mrs. Grace M. Grasso charged that Goodrich failed to perform tests on emis I sions of vinyl chloride gas from its PVC plant, which opened in 1970 less than two ' miles from Mrs. Grasso's home. Mrs. Grasso's husband, John C. Grasso. died of liver cancer in January, 1977, at the age of forty-nine. Mrs. Grasso was awarded $391,291 in compensatory damages, inelud- ini? over $37,000 to cover medical expenses Ancorred during her husband's six-month Illness and $205,000 to cover his future esti mated wages. _ believe that exposure to I vinyl chloride at the low level found at Ped ricktown could not have caused Mr. Gras so's angiosarcoma," Goodrich said in a prepared statement. The company says its belief is based on laboratory studies and medical evidence. "All angiosarcoma cases attributed to vinyl chloride exposure," the company adds, "have been in workers who have experienced high concentrations of vinyl chloride in the workplace over long periods of time. The Pedricktown facility began operations only in 1970 and has not : emitted high levels of vinyl chloride, In fact, no one either inside or outside any Goodrich facility is being exposed to such conditions," Goodrich says, A Goodrich spokeswoman In its Akron, Ohio, headquarters says Mrs. Grasso's case is the first of its kind brought in con nection with the company's Pedricktown plant. Goodrich is reviewing the court's de cision and is considering an appeal, the spo keswoman says. SAL 0001.03256 VINYL CHLORIDE AND BIRTH DEFECTS In the la te summer of 1974, a researcher in Ohio reported that vinyl chloride gas might be contributing to a higher than normal incidence of birth def acts among children born in communities where such gas is produced or where it is used in the manufacture of polyvinyl chloride res in. In early 1976, an excess of stillbirths and miscarriages am ong the wives of heavily exposed vinyl chloride workers also was re p|orted. Much misinformation and misunderstanding has resulted fr o n these two reports. The purpose of this paper is to put forth th e facts and to set the record straight. This paper documents three key points: Resear ch conducted in Ohio purporting to show a relationship betwe en vinyl chloride emissions and an excess of birth defect s has been roundly criticized by experts in the field and has been refuted by a series of studies conducted by the F ejaeral Center for Disease Control. AccordlLi ng to experts from Harvard University and the University of Texas, the single study alleging an excess of stillbirths and miscar riages among the wives of heavily exposed vinyl chloride worker s is "inadequate,'' "misleading" and essentially "worthless." Two s ^parate animal studies found that even at extremely high levels of exposure, vinyl chloride did not produce mutagenic or tei atogenic effects in the test animals even though it has been f D und to be capable of producing a mutagenic reaction in salmonle 11a bacteria. 2 Background In January 1974 three cases of angiosarcoma, an extremely rare type of liver cancer, were discovered among long-term workers exposed to high concentrations of vinyl chloride monomer (VCM), the gaseous industrial chemical used to produce polyvinyl chloride (PVC) resiiJ. Ultimately, over a period of 16 years, 23 deaths were confirmed ip four U.S. plants, and approximately 48 in other countries. The workersr jobs principally involved cleaning residue of PVC resin from the polymerization reactors in which it was produced from VCM. As a result of these findings, the U.S. Occupational Safety and Health Administration in 1974 announced standards to drastically reduce worker exposure to vinyl chloride. In 1976 the Environmental Pro tection Agency issued regulations limiting emissions of VCM into the atmosphere around vinyl chloride and PVC resin plants. The Food and Drug Administration currently is considering regulations on the use of PVC food and beverage packaging materials. Because of these regulations and through industry efforts, VCM exposures in the workplace have been reduced a hundred-fold or more in the past four years.. Emissions into the atmosphere have been decreased by over 90 percent. Similarly, new and better PVC packaging materials nave been developed to eliminate the possible migration of residual v[lnyl chloride from the PVC into finished food and beverage products. SAL 000103259 -3- Additional Research Conducted As a con sequence of the angiosarcoma discovery, a wide range of scientific esearch projects have been undertaken or expanded in the past fe * years to investigate further the possible health effects of vinyl ch Loride exposure. Among other findings of this research, VCM was sho i*n to be capable of producing a mutagenic reaction in salmonella Dacteria; and an increase in chromosomal breakage was found in a small number of heavily exposed PVC polymerization workers although, ii n another study, no chromosomal changes were seen in workers exposed at lower levels. Because of these findings, concern was raised that VCM might also cause malformations or birth defects in humans. Study of Ohio VCM Plant Towns Undertaken To invee tigate this supposition, Dr. Peter F. Infante, then of the Ohio Dep artment of Health, examined the birth records of children born betwee n 1970 and 1973 in three towns in northern Ohio -- Painesville, Avor Lake and Ashtabula -- that contained vinyl chloride polvmerization Dlants. In a pr liminary report released in August 1974 and in a paper subsequent] y published in 1976, Dr. Infante reported that the rate of birth d< f ects, based on hospital records, in each of the three Ohio towns was significantly higher than the average for both the state of Oliio and for the balance of the three counties in which the towns \ re re located. SAl. 000103260 4 Dr. Infant 2 further reported a major excess in birth defects of the central n|ervous system (CNS) , which he considered to be "the greatest cau s|e for concern," and also in adult deaths from CNS cancer. These rep orts attracted wide press attention and speculation, even though Dr. I rfante, in his Academy of Sciences paper, had warned: "These preliminary findings do not link polyvinyl chloride production facilities with the increased occur!ence of congenital malformations and CNS tumors in adults, but indicate the need for further study of possible contributing factors." While the press totally ignored this statement, a careful analysis of the data Contained in the report lends credence to the reservations expressed in the paper's conclusion. In addition, serious questions as to the qu lity of the research and the value of the findings of the study ha\ e been raised by two eminent scientists -- Dr. Brian MacMahon, ch<. irman of the department of epidemiology, Harvard University Graduate SchA ol of Public Health, and Dr. Thomas D. Downs, professor of biometry, University of Texas Health Science Center. The two scientists wi re engaged by The Society of the Plastics Industry to conduct independent critical reviews of all known literature relating to vinyl chip ride and birth defects. For compa ison purposes, the Infante study examined the birth defects ratefc in nine communities without PVC facilities, but which were located in the same general geographical area as the three plant towns. Two 5f them were found to have birth defects rates higher than any of he communities with PVC facilities. 000103261 Bftb 5 Not only was this discrepancy unexplained, but the report also combined ca ses of CNS malformations from one of these two com- munities -- North Ridgeville -- with those from the three plant towns in de reloping the basic statistics. This unusual procedure was explain id in the report by stating that North Ridgeville was " proximate" to one of the plant towns. In reality, the two are nearly 10 m Lies apart -- approximately twice the distance that the Environinental Protection Agency has determined, through extensive a Lr monitoring, as the maximum that vinyl chloride gas can travel through the air before decomposing into other, non- toxic, mat erials. The incl asion of North Ridgeville data in the Infante study is both mislead ing and inappropriate. Dr. MacMahon, in his critique of the stud^ ,called the addition "completely unjustified." Dr. Downs said "in our judgment the inclusion...is reprehensible." In addit ion, if one examines the data from the four towns separately, rather than in combination, the fact emerges that while one of the plant towns -- Painesville -- did have over half of the observed C* S birth defects, the non-VCM town had 2 5 percent of the total. Anc ther of the plant towns -- Avon Lake -- which has had a VCM faci3 ity in its midst for the longest period of time of all three comm i niiti;es, had no CNS defects at all. Nearly i he same situation applied in the case of CNS cancers among adult s. The report, once again, added cases from North Ridgeville to the three plant towns. When examined separately, only Paine^v ille and North Ridgeville, which has no VCM facility. showed an exce ss of adult CNS cancer deaths. plant towns showed no excess. The other two VCM ~SAaL> - 00010326 - 6- When the lard data from the three VCM plant towns and North Ridgeville a :e examined individually, more unexplained differences than similar .ties in CNS malformation and adult cancer rates emerge. The procedure of "combining" data from three widely separate com ^unities -- Painesville is located about 30 miles to the west Df Ashtabula and Avon Lake lies another 50 miles west of Pain ssville -- plus a town without a VCM facility. effectively obscured these significant differences. The sourc 2S Infante used for information on birth defects are routine repo rts of birth. Dr. MacMahon points out in his critique that birth c =rtificates are "a notoriously poor source of information on cong enital malformations." He states that the rate for the state of Ohio as a whole suggests that only about half the medically si gnificant malformations are being reported. Equally a s important as the manner in which the data was compiled and presente d is the fact that no attempt was made to determine whether any of the mothers involved (or their husbands) had ever been exposec to vinyl chloride, either by working in one of the VCM plants or.b' living in close proximity to them. Nor were any measure- ments made o determine if there was any vinyl chloride at all in the ambient air in these communities. Furthermore, interviews were not conducted o: any of the subjects to determine, for example, if there was a histo: y of birth defects in the family or if the mothers might have been e: posed during pregnancy to some other toxic substance. Also, no at .empt was made to compare the current birth defects rate with those xisting before the VCM facilities were constructed. SPiL 000103263 -7- Dr. MacM hon in his critique states that while Infante focuses attention on the central nervous system defects because of their unusual sever ity, 13 of the 17 categories examined are in excess and several $uch as oral clefts and club foot are in substantial excess. Sine e known teratogenic agents in humans and experimental animals produ ce specific malformations, it is unlikely that any agent would iroduce the variety of malformations found in excess in these cit es, Dr. MacMahon says. A more likely explanation, he states, is S' me artifact, such as reporting differentials, that would apply to all categories of malformation. Dr. MacMa ion cites numerous shortcomings in the Infante research and sums up lis critique by stating: "I am fairly well convinced that the fi n ling results from a combination of chance, reporting differential and epidemiologic gerrymandering." Dr. Downs, also highly criti al of the research procedures, concluded his review with the comjn ent: "It does not seem possible to salvage anything from this sthdy Birth Defects Questions Studied by CDC Because of the questions raised by Dr. Infante's Ohio study and the publicity that his results were receiving, the Center for Disease Control (CDC of the U.S. Department of Health, Education and Welfare undertook an investigation of the possible relationship between vinyl chloride exp sure and birth defects in humans. \ SAL 0:l 03264 3- The resu ,,ts of this investigation were published in the July 19, 1975, issue of Morbidity and Mortality, an official CDC weekly publication. I; i the first section of the two-part study, a comparison of birth def net rates in hospitals in two widely separated cities with VCM ins :allations -- one in Pottstown, Pennsylvania, the other in Painesvil . e, Ohio (which was included in Dr. Infante's study) -- showed no ra :e increase in the Pennsylvania community as compared with the sta :e average. The CDC investigation did find an increase in CNS malfo :rmations in Painesville, similar to that reported by Dr.. Infante. The seco id part of the CDC study involved a thorough investigation of the 15 ca es of CNS malformation recorded at the Painesville Hospital from 1970- 19 7 4. For each malformation case, two normal births were investigated as "controls" for comparison purposes. The results of this researc l, which covered a number of factors not included in Dr. Infante1 study, can be summarized as follows: None of the interviewed parents of the children with CNS birth def e :ts ever worked at either of the two VCM polymerization plan L s in Painesville (one set of parents could not be locab ed, but records show they did not work at the plant at 1i e time of their infant's birth). In 11e "control" group, two of the fathers of "normal" chil ren were working at one of the VCM plants at the time of 11 eir infants' births. SAL 00010326  Neithe c of the parents in either group lived within two miles of either of the two plants. A stat istical analysis of the actual distances between the two VCM plants and both residences and workplaces of the parents of "cases" and "controls" showed no differ ence between either group. The CDC co ncluded, on the basis of its own investigations and a thorough analy sis of the existing research data, that while the possibility could n ot be ruled out that VCM might be teratogenic (capable of causing ma l|formations) , the evidence to date did "not establish any associatic n between (birth defect) cases and vinyl chloride exposure." The result s and conclusions of the CDC investigation were also published for professional scrutiny in the November 29, 1975, issue of The Lancet, a f restigious British medical journal. Dr. MacMaf on concluded that it is not the presence of the two PVC plants the t is responsible for the high malformation rate in Painesville. The most likely explanation, he said, seems to be "random flucti ation." Second CDC Im estigation Undertaken* 0001 Despite t! e publishing of the CDC research, some individuals . continued to i efer to Dr. Infante's study as the definitive, and indeed the only, inve itigation into the possibility of vinyl chloride induced birth defects, Dr. Infante, in defense of his own work, argued that there were se-\ eral methodological errors in the CDC study that could account for i l.s negative findings. 0001 10 In order to settle the question once and for all, CDC decided to undertake a s scond, even more definitive investigation. The methodology for the study was modified to take into accc.:nt Dr. Infante's objections, Charleston/ West Virginia, where a vinyl chloride plant had been loca ted since 1938, was selected as the study site. The investigation began in February 1976 and the results submitted in report form to the Director of CDC by the Cancer and Birth Defects Division of th e Center's Bureau of Epidemiology on July 26, 1976. Study Finds "No Relationship" As in the earlier study in Painesville, Ohio, researchers con tacted the pa|rents of all children born with CNS defects in Kanawha County (Charleston and suburbs) from 1970 to 1974. A "control" group, consisting of the parents of "normal" children born in the same hospital immediately before or after a child with a CNS defect, were also interviewed. Air pollution, prevailing wind and other data were also collected. The results of this investigation can be summarized as follows: Except for 1974 (the last year included in the study),rates of CNS birth defects in Kanawha County were higher than total U.S. rates. Five "case" parents out of 41 (those with children born with CNS cefects) and no "control" parents reported a family histcry of CNS defects. s^l 00;l Q'?67 11 TWO case" fathers and two "control" fathers were employed in tl e VCM plant at the time their children were conceived, Three additional "control" fathers had worked in the plant on a contract basis for a short time and therefore also had p ossible exposures. No me thers in either group had ever worked at the plant. Using sophisticated analytical techniques, no significant dif f e rences were found between the two groups as to their place s of residence in relation to the plant at the time of t he ir infants' conception. The study noted, however, that of the nine "case" parents and ten "controls" w ho lived within three miles of the plant, most of the "case" parents tend e d to live east of the plant, while most of the "control" group lived SD uth of the plant. Because o f this curious case "cluster," CDC said it "gave particular at tention to the possibility that the cluster may have been cai: sed by increased VCM emissions." While winds in the Charleston ar 5a are highly variable, the West Virginia Air Pollution Control Commi ssion reported that suspended particulate matter, a good indicator of e/ind direction, was heavier in the southwest, thus "sug- gesting a pre /ailing wind from the northeast," i.e., away from the "cluster" and the plant. Furthermo re, if the case "cluster" was the result of VCM plant emissions, CD 2 theorized that "one would also expect an approximate correlation b 2tween a decrease in atmospheric VCM levels and a fall in CNS defect rates." According to the report, no such correlation was found. SAL 000103268 - 12 - The repor : concluded: "The investigation did not reveal an association between the case clustering within three miles of the plant and exposure to VCM or other chemicals." In its s unmary of the entire study, CDC concluded that "no relationship between infants with malformations and parents' exposure to vinyl chloride could be established." The CDC's conclusion was strongly supported by Dr. Downs. After a comprehensi /e review of the data in the CDC study, he said: "Our conclusion, th srefore, is that the available scientific evidence does not indicate any association between vinyl chloride and community birth defects No Link in Ca "ladians' VCM Study In October , 1977, Dr. Gilles P. Theriault, Chairman of the Depart- ment of Social and Preventative Medicine at Laval University in Quebec, reported at 11 e annual meeting of the American Public Health Association on a prelimin ary study comparing birth defect rates in two widely separated industjr ial communities in Quebec. One community -- Shawinigan -contained a pblyvinyl chloride production (PVC) facility. The other community -- Drummondville -- did not have such a plant. The two industrial c cfrnmunities of approximately equal population are more than 50 miles apart. In his re port, Dr. Theriault noted an apparently higher rate of birth defects in Shawinigan, the city with the PVC plant. He pointed out, however, that while the industry in Drummondville is primarily textile, in 5 lawinigan there is "an aluminum refinery plant, a carbide plant , a chemical factory and a pulp and paper mill." SAL 00010326? 13 Referring to t he presence of other atmospheric pollutants in the environment oi Shawinigan, Dr. Theriault said, "The present study does not permi t linking the observed phenomenon to a particular pollutant, be i t vinyl chloride or any other teratogenical agent." To arrive at his conclusion that a higher overall rate of birth defects exists d in Shawinigan, Dr. Theriault combined all types of birth defects, But as Dr. MacMahon has pointed out in a review of a variety c f birth defect studies, "the known teratogenic agents in humans and experimental animals have considerable specificity in the malformati ons they produce." Therefore, Dr. MacMahon concluded it would be " vjnlikely" that any one pollutant would be responsible for the full i ange of birth defects reported in studies similar to Dr. Theriault1 s. A more likely explanation is that some artifact is responsible -- such as reporting differentials -- that would apply to all c ategories of malformations, he said. Dr. Downs, who also undertook an independent review of birth defect researc h, also stated that the pattern of birth defects in the Theriault study is consistent with known incidences of the various malformations If a single teratogen were involved, he concluded, one type of bi rth defect would most likely be greatly increased, rather than e slight increase observed for most of the deformities on the list Even Dr. 1 heriault found the increase in birth defects in the same order of magn i|tude in several organ systems "puzzling." The explanation, he said, could be that the chemical (vinyl chloride) in the Shawinigan en\ ironment produces by itself or in combination with other air pol] utants a broad spectrum of developmental effects. SAL 0001032 14 Or, he said, th apparent influence between Shawinigan and Drummondville can resu 1 ^ from an artifact such as ignoring defects diagnosed after hospital iischarge, different diagnosis or different reporting criteria used 1i 1 the seven hospitals contacted. Dr. Theriau Lt appears to be in agreement with other scientists who have raised, serious questions on the significance of the data obtained in this most recent study. In the conclusion of his report, he acknowledges that "further studies are needed to assert that vinyl chloride causes birth defects in the community living near a polymerization plant." Vinyl Chloride and Fetal Deaths In early F ebruary, 1976, Ralph Nader's Health Research Group released to the press th e text of a study scheduled to be printed in the April 3, 1976 issue of Uhe Lancet. The study by.Dr. Infante etal., was conducted at a single PVC resin plant in Pennsylvania. It purported to show thatthe wives of worker s exposed to heavy concentrations of VCM had a statistically signi ficant increase in the number of stillbirths and miscarriages compar ed to the wives of workers exposed to little or no VCM. While the ijesearch results certainly merit further investigation, there are a nun her of factors in the study that have raised some doubts concern j ng the sweeping conclusions that have been reached from the reseaifc h. SAL 000:103271 15 For exam e, the number of families participating in the study -- only 62 in th e "exposed" group -- is quite small. Second, the wives themselves w re not interviewed by the researchers, nor were their ages at the ifime of conception obtained. All data in the study was based solely on the "recall" of the husbands. Similarly, hospital or other med: cal records were not checked, nor was any attempt made to contact tl e wives' doctors for their possibly valuable input, Even more importantly, there is no indication in the report that any attempt v as made to correlate fetal death rates with either length or degree of exposure. This is especially vital in light of the fact that the husl ands in the "exposed" group who were 30 years of age and older (ard who presumably had the greatest accumulated exposure), did not repo 21 an excess of fetal deaths when compared to those 30 and older in the "control" group. In additi on, when women with chronic stillbirth and miscarriage problems were eliminated from the study (standard procedure in research of this type , the difference in fetal death rates between the "exposed" and "control'^ groups was not reported as statistically significant by the authors. Both Dr. MacMahon and Dr. Downs, after separate reviews of the study, were hjighly critical of the analytical methods used. Dr. Downs said that the "misleading conclusions" drawn by the authors were brought about through the "selection and use of their control group." Dr. MacMahon called the data "worthless," the analysis "naive" and the test "in adequate and misleading." "In short," he said, "this paper is stre .vn with evidence of carelessness and incompetence and deserves, in my opinion, no consideration whatsoever in weighing the SAL 000103272 - 16 - question of wl. ether there is or is not a genetic risk associated with exposure to VCM. 11 Animal Studies Show No Teratogenic Effects From VCM In 1977, .A. John, et al., conducted animal studies on rats, mice and rabb:. ts to determine the effects on fetal development when the subjects nhaled vinyl chloride. Groups of mice were exposed to 50 ppm and rats nd rabbits were subjected to 2,500 ppm of vinyl chloride. In the summary of their report, which was published in Toxicology and Applied PI. armacology, the authors said, "While maternal toxicity was observed, vinyl chloride alone did not cause significant embryonal or fetal toxic ity and was not teratogenic in any of the species at the concentrations tested." Two years earlier in 1975, I. Purchase, et al., carried out an animal study in England on the chromosomal effects from inhalation of vinyl chlor ide. Fifteen male mice were exposed to VCM levels of 30,000, 3,000 and 1,000 ppm of vinyl chloride for six hours a day for five cons ^cutive days. Examinations were carried out after each male was mated with a female. In their report, which was published in i^he August 1975 The Lancet, the authors said: "There was no significant increase in the number of early deaths per implantation compared with the control group exposed to air alone, indicating that VCM does not produce dominant lethal mutations in mice at these exceptional h: gh levels. It appears, therefore, that the mutagenic effects of vi liyl chloride, expressed as chromosomal aberrations in lymphocytes, do not occur in the germ cells...The potential danger of mutagenic ffects on the fetus via the sperm does not, therefore, SAL 000103 17 seem to exis Unfortunately, the details of this animal study have not been pub ished. This same report did suggest that increased chromosomal hanges could be seen in highly exposed workmen. Conclusion Since 19 4, a number of studies have been undertaken to determine the potentia mutagenic or teratogenic hazard of vinyl chloride exposure. Exti nsive experiments conducted by the U.S. Center for Disease Contr ol have failed to discover any relationship between birth defect in children and their parents' exposure to vinyl chloride. Th is research refutes an earlier, less definitive study conducted in three towns in Ohio, and a more recent one conducted in Canada, Animal studies have likewise failed to find a link between VCM exposure and either mutagenic or teratogenic effects, One study undertaken at a single plant in Pennsylvania, which reported tha-: the wives of workers exposed to heavy concentrations of vinyl chlo ride had a greater number of stillbirths and miscarriages than the wive s of workers exposed to little or no VCM, has raised numerous que stions by experts about the methodology and conclusions drawn from tAis study. ### March 1978 For Additions 1 Information Contact: The Society c f the Plastics Industry, Inc., 355 Lexington Avenue New York, N.} 10017 (212) 573-9400. Ar\ O'? 0 ooi-00"- /LAj. J 0 7INYL CHLORIDE MIGRATION AND FOOD PACKAGING In e arly 1973, a national distiller reported to the Treasury Department's Bureau of Alcohol, Tobacco and Firearms (BATF) th 5 presence of vinyl chloride in distilled alcoholic beverages packed in experimental polyvinyl chloride (PVC) bottles. As a resu It of the report, BATF banned the further use of experimental P yC bottles with alcoholic beverages and the Treasury Departmen t withdrew its provisional approval for the use of PVC bottles f or distilled alcoholic beverages. The Food and Drug Administr ation (FDA), which has responsibility for "alcoholic foods" un der the Food, Drug and Cosmetic Act, proposed a regulation banning th e use of PVC from all alcoholic foods and began to study the question of vinyl migration from food packaging containing vinyl chi oride. All of this occurred prior to a discovery in 1974 whic h associated vinyl chloride monomer (VCM) with cancer in humans Sine e the initial report of vinyl migration and following the estat lishment of the cancer link, an environmental group has petitions d the FDA to ban completely all PVC food packaging material . The FDA has proposed a regulation that would withdraw its "pric r sanctions" from rigid and semi-rigid PVC packaging products and has fanned the use of another chemical product, acrylonitrile (AN) , to fabricate beverage containers. During the last five years, ns wer, more sensitive equipment has been developed to measure vinyl ch oride migration and PVC manufacturing processes have SAL 000103275 2- - been drama tically improved which permit the production of packaging materials containing only minute amounts of residual vinyl chic ride monomer (RVCM). In other areas, a number of legal actions have been taken by various groups which sometimes have tended to cloud rather than clarify the issue. In addition, the results of several complex scientific studies have not been clearly understood. The result has been confusion and apprehension in the public's mind concerning the use of packaging materials made of PVC. The purpose o:; this paper is to present the facts regarding vinyl chloride migration from food packaging and to place the issue in its proper perspective. This paper documents four key points: / There is no reasonable likelihood today of vinyl chloride mmoraer (VCM) getting into the diet from PVC food packaging m iterials. Today's virtually momomer-free PVC resins were developed tirough an intensive effort by the plastics industry wiich reduced the residual vinyl chloride monomer in rigid and semi-rigid products from 500 parts per million (500ppm) to as low as 2 parts per billion (2ppb). There is no scientific evidence to date showing that vinyl chloride monomer in the levels found in PVC food products is carcinogenic. n recent months the Food and Drug Administration (FDA) eppears to be reassessing its previously expressed position iegarding proposed regulations for the use of PVC in iood packaging materials. SAL 000103276 -3- Backgro ind 2arly in 1973, Schenley Distillers, Inc. reported to the U.S Treasury Department's Bureau of Alcohol, Tobacco and Firearmk (BATF) that it had found evidence of the presence of res;idual vinyl chloride monomer (RVCM) in distilled alcoholic beverag|e s, such as vodka and gin, which it was packaging in experirr|ental bottles made of polyvinyl chloride (PVC) . The company said levels up to 20 parts per million (20ppm) had been found n vodka and 25 parts per million (25ppm) in gin. Regulation of the safety and purity of alcoholic beverages x normally handled by BATF. Legally, through its administratioi of the Food, Drug and Cosmetic Act, the Food and Drug Admin i tration (FDA) also has applicability to "alcoholic foods." In May 1973, the BATF banned the further use of experimental PVC pl<: Stic bottles for distilled alcoholic beverages and the Treasu: y Department withdrew its provisional approval for the use of PVC bottles for the same use. The FDA meanwhile published a proptfi sed regulation which would ban the use of polyvinyl chloride from a .1 alcoholic foods but would reaffirm the "prior sanctions" for al other uses. In addition the FDA began to study the questi >n of vinyl migration from food packaging. The Society of the Plastics Industry, Inc. (SPI) sub sequently supplied data to the FDA which indicated that small amounts of vinyl chloride could migrate to non-alcoholic foods from ollder formula PVC bottles then in production. But because the FdIa's expected proposal on food additive use of PVC was nearly] two years in coming, pressure on the FDA from consumer SAL 000103277 -4- groups and Congressmen began to build. These groups contended that "zero migration" could be the only "safe" level because there is nb safe dosage for a carcinogen. The actions by federal agencies to ban the use of PVC bottles f<Jr distilled alcoholic beverages and the data supplied by the SPj indicating that small amounts of VCM could migrate to non-alcohcalic foods from older formula PVC bottles, preceded an important public announcement by a large chemical company in January ISi74. The B.F. Goodrich Company announced that it suspected that VCM \las implicated in the death of three workers at the company1s Louisville, Kentucky, polymerization plant. the first association of VCM with cancer in humans. This was FDA and tfle Food, Drug and Cosmetic Act A 1958 amendment to the Food, Drug and Cosmetic Act requires that any new food additive must undergo strict testing to establish its safety. Not only are direct additions to the food coveJted by the amendment but also unintentional trace additions that might come from materials used in packaging food. These are known as "indirect additives." Hoi*ever, under the provisions of the Act, a substance is excluded EErom the definition of "food additive" if it may "not reasonably be expected" to become a food component or if its use was "sanctioned" by FDA prior to September 6, 1958, Several products polymerized from vinyl chloride were approved prior to that date and as a result PVC resins were considered to have "prior sanction." SAL 00010327E -5- The J'DA is authorized to re-evaluate the safety of any substance used in food-contact articles at any time. Use of a prior-sanctioned substance may be prohibited or limited when FDA determines that such use may be injurious to health. FDA Bans Only PVC Rigid and Semi-Rigid Products In Jily 1975, the Health Research Group, one of the Ralph Nader affiliated groups, petitioned the FDA to ban completely all PVC fDod packaging. That September, the FDA responded by: 1. Withdrawing its "prior sanctions" for all rigid and semi rigid PVC products. 2. Propo sing a ban on the use of rigid and semi-rigid PVC produc ts, including bottles, blister packs, boxes and pipe, except water pipe. 3. Permitting the continued use of water pipe under an interim food additive regulation until further proof of "no migration" is obtained. The FDA further stated that it had reason to believe there was no migration from plasticized PVC film, can and cap liners, coatings, gaskets of flexible tubing and, therefore, proposed to affirrrl the previous sanctions for their continued use. Data Shov s No Risk To Public In liid-December 1975, the SPI submitted its comments on the proposed FDA regulation. The detailed submission consisted of 125 page^ of comment and 700 pages of data to show that manufacturing processed for PVC had been dramatically improved and that there was no risk to the public from the use of PVC food packaging material^ because: SAL. 000103279 -6- All new PVC packages contain essentially no detectable vinyl chloride monomer when tested using the FDA test n ethod. Pny vinyl chloride that might have entered food packaged in old packages would probably have evaporated rapidly before ingestion could have occurred. Thet SPI pointed out that the probability of vinyl chloride monomer cetting into the diet from packaging materials was. theref02<= , virtually nil. However, the SPI urged the FDA to adopt a < ubstitute ruling which would require that rigorous test methods be used to assure no reasonable expectation of VCM migratic511 . On :he same date that the SPI submitted its data, the U.S. Council on Wage and Price Stability asked the FDA to withdraw its pro] 5osed PVC regulations on the grounds the actions may be "unneces3 >ary or may be more restrictive than is required to prevent ingestic3i of vinyl chloride." Not Care:Lnoqenic Except at High Levels In the middle 1970's, Dr. Cesare Maltoni of the Institute of Onco.LDgy and Tumor Centre of Bologna, Italy, reported that he had .nduced tumors in rats by ingestion of vinyl chloride. However , his experiments were conducted by gavage (introduction of mate.trials into the stomach by a tube) and at extremely high dosages By comparison, the SPI1s 1975 proposal to the FDA would prevent human ingestion of VCM even at levels 1,000,/000 or more times 1<:wwer than those used by Dr. Maltoni. SAL 01032S -7- Studies in the mid 1970's by Dow Chemical Company on how the body handles inhaled VCM tended to confirm the results of earlier Reports, including those of Dr. Maltoni, that only at high dos^ levels does VCM overwhelm the body's natural mechanism for eliminating many unwanted materials from the system. Industry Reports VCM Reductions to FDA In anuary 1977, representatives of companies producing PVC met with FDA officials to present and discuss information on the industry s capabilities for minimizing residual vinyl monomer content C 'f rigid and semi-rigid PVC bottles and sheet materials, Many of it-he industry scientists reported that at levels of apparent extracted "vinyl chloride" below 10 parts per billion (lOppb) , great difficulty was experienced in confirming that the tests re 4lly were showing vinyl chloride rather than some other " interfe: ences" extracted from the PVC package, One of the companies at the FDA meeting reported that since Jaiuary 1975, all of its PVC food grade bottle compound was produced to a controlled specification of less than one part per mill on (l.Oppm) vinyl chloride monomer. The company said these leirels represented a 500-fold reduction from the levels in 1973. At :hat January meeting, the FDA requested additional raw data froih the SPI to justify the industry's claims regarding residual monomer levels of the materials then being produced, The FDA ilso requested further details on the analytical pro- cedures >eing used by the industry. The industry agreed to supply the infofc: rmation SAL 000103281 8- - Data Show ; Great Reduction in VCM Level In April 1977, the SPI submitted the data requested by the FDA' Bureau of Foods at the January meeting. The data showed th 2 PVC industry had reduced the residual vinyl chloride monomer rigid and semi-rigid products from levels of approx- imately 5 DO parts per million (500ppm) to levels well below five one hundredths parts per million (.05ppm). Also, as requested by the FDA, the SPI provided a detailed rationale explaining why no vinyl chloride can reasonably be expected to migrate rom such rigid and semi-rigid PVC food-contact products VCM Leve "Vanishingly Small" Iri early 1977 , Ethyl Corporation submitted to FDA a report of an experiment which determined that "VCM can be reduced : n container walls to a point where VCM cannot be detected in container contents" and thus might be described as "vani ihingly small." The Ethyl Corporation experiments establis led that at a level of eight one hundreths part per million 0.08ppm) or 80 parts per billion (80ppb) no migration occurred in its bottles. "Thus no VCM could reasonably be expected tb become a component of the bottle contents under intended conditioi s of use." Lhter in the year, FDA raised technical objections to the EthyfL data and would not agree that there is no migration from PVC containers with a finite level of VCM. The Ethyl Corporation agreed to supply the additional supporting data requested by the FDA. SAL 00010328 -9- SPI Asks or Amendment of "Food Additive" Definition The find of March 1977, SPI filed a petition with the FDA to amend :he regulatory definition of "food additive." The SPI petit on proposed that a substance which poses no special toxicolog. cal problems and which cannot be detected migrating to food w th an analytical procedure sensitive to 50 parts per billi<t> n (50ppb) would, by definition, not be considered to be a food additive. As of the end of June 1978, the FDA had not yet ruled on the SPI petition. Acrylonitrile Enters the Picture In A 2 gust 1977, an FDA Administrative Law Judge ruled against the use o : acrylonitrile (AN) to fabricate beverage containers. That fall , in a letter to the Ethyl Corporation, FDA Commissioner Donald Ke inedy said the final rule on the use of polyvinyl chloride food pack^ ging materials "will necessarily reflect many of the judgments and conclusions of the law reached in the related' final decision :>n the status of acrylonitrile." On Saptember 17, the FDA issued a final order banning the use of AN for beverage bottles. A month later, as the first step in appealing the FDA's acrylonitrile (AN) beverage container decision, the SPI filed a "Petition for Review" in the United States Court of Appeals in Washington. Similar petitions and amicus curae briefs were submitted by several companies. New FDA Sensitive Analytical Procedure At a meeting with scientific staff members of the FDA's Bureau of Foods in September 1977, industry representatives learned SA[- 000103383 -lo for the f rst time that the FDA had developed a new improved analytica procedure for determining RVCM in packaging materials sensitive to the low parts per billion range. The industry further learned th at the procedure had been used to reassess the RVCM content o flexible PVC packaging materials and that levels in the low p arts per billion range were found, In J.lnuary 1978, in a letter to FDA Commissioner Donald Kennedy, enneco Chemical Company said that it had learned that FDA scientists had developed new techniques for determining RVCM in f') od-contact materials which were sensitive to detections of one to two parts per billion (l-2ppb). As these new techniques may have jeen applied to Tenneco rigid and semi-rigid products, the compa ly said, it wanted the opportunity to submit additional data to t lat which it had submitted to FDA in 1975. At that time the techn Lque developed by the FDA had a lower level of detection of 350 pa :ts per billion (350ppb). Furthermore, Tenneco said its own analy|t ical chemists evaluated the new FDA techniques and their evaluatio l was that there were significant problems with the new FDA techn Lques that make them unsatisfactory for determining RVCM in PVC fi Lm. Tenneco also urged that a further final comment period be offere 1 prior to adoption of the final order on vinyl chloride polymers Ln contact with food. In r ssponse to' the Tenneco letter, William F. Randolph, FDA Acting As sociate Commissioner for Compliance, said the FDA was "aware tha t the circumstances have changed significantly since our proposal (PVC regulations) was issued on September 2, 1975" and that *the public will be given an additional opportunity to submit data and comments. "The precise nature and timing of 'that oppor- tunity* h ave not yet been decided," he said. SM- 000303284 -11- Residual V2M Reduced To Two Parts Per Billion In m id -February 1978, Ethyl Corporation presented preliminary data to FE h technical personnel which showed that residual vinyl chloride n onomer (RVCM) can be stripped from PVC to a level of approximat ely two parts per billion (2ppb) and said that this "may well be t e lowest level to which RVCM can be reduced," FDA scientist agreed that if these data are confirmed and supplemented by studies with bottles, the diffusion model for predicting migration (used for AN) would not be applicable to these low levels of RVCM. Thus, the principles of the AN beverage container decision vfould not be relevant to PVC containers. Maltoni D. ta Fails To Show AN Carcinogenic A ma or criticism of risk extrapolations for both acrylonitrile and vinyl chloride was that they were based on the results of incomplete feeding data in one case and on inhalation data in the other. In the early spring of 1978, Prof. Maltoni reported that he had now completed his ingestion studies of acrylonitrile and vinyl chip ride. The final report on the acrylonitrile study on rats fail d to show whether or not AN is carcinogenic. The report concludes that under experimental conditions at a level of 5 mg/kg administe red to the rats three times per week, AN exhibited a "borderlih e oncogenic effect." However, the researchers reported "at prese it, our data do not make definitive evaluations possible," and they roposed further investigations. Whil Prof. Maltoni's ingestion and inhalation studies of the effect s of vinyl chloride on rats has been completed, his final report hals not yet been released. It is expected shortly. Some SAL 00010328 -12- indication of his findings may be reflected in a talk he gave two years ago In M& rch 1976 at a Colloquium held in Paris, Prof. Maltoni presented a comprehensive review of his work to that date on vinyl chl^) ride carcinogenicity. A monograph of the papers and discussio is at the Colloquium has just become available, From his gavage (stomach tube) animal feeding experiments, Prof. Malt oni drew the following conclusions: 1. At 50 mg/kg and 16.65 mg/kg VCM produces angiosarcomas of the liver and nephroblastomas (abnormal growth in kidneys). These two tumors are the most characteristic produced by the VC moiomer. At 3.3 mg/kg the two angiosarcomas which were observed were not located in the liver (one appeared in the lung, the other near the kidneys). 3. There is a clear relationship between dose of monomer and tumor response with a sharp drop-off between 16.65 mg/kg and 3 .33 mg/kg. Prof . Maltoni further stated that in his experiments the 3.33 mg/k|g dosage appeared to have a "border line" carcinogenic effect, He also reported that in another experiment in which animals w sre treated with 1 mg/kg, 0.3 mg/kg and 0.03 mg/kg, no tumors had been observed after 57 weeks into the test, At t he Occupational Safety and Health Administration's May 1978 public he arings on the establishment of a generic occupational cancer pc licy. Dr. David P. Rail, director of the National Institute of Envirc nmental Health Sciences, testified that humans appeared to be 50C times less sensitive to vinyl chloride than the most sensitive laboratory animals when doses are compared on the basis of lifeti me intake in miligrams per kilograms body weight (mg/kg). SAL 000J03, -13- Different "Risk Assessment" Methods Used In the early Spring of 1978, the FDA made available an assessmen; of the risk of liver cancer from aflatoxin contamination of corn a: id peanut products. A careful study of the report showed that the DA had drastically departed from the methodology the industry lad used for vinyl chloride and acrylonitrile risk assessme n In the case of VC and AN the risk extrapolation was hand!, 2d very conservatively using the Mantel-Bryan "worst case" sta tistical interpretation in a manner to yield a 99 percent confidenc 2 factor for the result. No such conservative treatment of the to xicological data was applied for aflatoxin before per- forming t he Mantel-Bryan extrapolation, Us ing the more conservative procedure as a model and all available data on VC and AN, a staff scientist at Keller and Heckman, legal counsel to SPI, recently calculated the risk from canc er associated with these two residual monomers in food packaging Although his calculations should be considered only illustral. ive and not conclusive because he lacked complete data, his find: ngs do give a rough indication of the risks involved. Cancer Ri sk: One In One Hundred Million Wlhen the scientist applied the Mantel-Bryan "worst case" assumptions to vinyl chloride he calculated that if a man's entire diet was contained in PVC packaging a safe total dietary exposure to man would be 5.2-10.4 parts per billion (ppb). Since it is assumed that PVC could not package more than 10 percent bf the diet, an actual migration level of ten times the safe exposure level could be set as a "tolerance." This tolerance SAL 000.103287 -14- (not more than 52-104ppb migrating to food) assures that the risk of cancer would be far less than one in one hundred million. Therefore a finding of "non-detectable" with an analytical method sensitive to two parts per billion (2ppb) should assure virtually absolute safety. In a similar calculation for AN, assuming that 5 mg/kg administered three times a week is a "no effect level," and that no more t lan 50 percent of the carbonated beverage consumption were packaged in AN copolymer containers, the scientist calculated a toleran :e of 31 parts per billion (31ppb) would be virtually absolute safety. Therefore, the present analytical sensitivity of 10 parts per billion (lOppb) is sufficient to reduce any risk from AN to below any meaningful level. Conclusio n Muo h has happened since the controversy over the migration of residu al vinyl chloride monomer (RVCM) from food packaging arose in 1973. Newer, more sensitive equipment and more advanced t dchniques have been developed which permit the measurement of IVCM migration in parts per billion instead of parts per million. Ir the last few years PVC manufacturing processes have been drai.atically improved. One company reported that it had stripped RVCM to as low as two parts per billion (2ppb) which, it said. may be the lowest level to which RVCM can be reduced. Another Company reported it had reduced the VCM levels in its general purpose bottle-compound by 500 fold in three years and was cont nuing to improve its technology for further reductions. SAL 0OJ.0328, -15- Sev ral studies have shown that vinyl chloride is not carcinoge nic except at high levels and PVC packaging being supplied to end product manufacturers in the last few years contain 3 ittle or no measurable residual monomer. There is, therefore , no reasonable likelihood of VCM getting into the diet from pres ent PVC food packaging materials and no scientific evidence that VC monomer can be found at any level in food products now packaged in PVC. ### July 1978 For Additional Information Contact: The Society of the Plastics Industry, Inc 355 Lexii.gton Avenue, New York, NY 10017 (212) 573-9400 SAL 00010328? REPRODUCTION STUDIES WITH VINYL CHLORIDE Reproductive studies conducted in 1975--76 by Dow Chemical showed that vinyl chlorid e, 500-2500 ppm, had no effect on implantation, resorption, or skeletal/organ development in mice, rats, or rabbits. &8L OOOl 032 98 (conoco) Interoffice Communication To Distribution From J . t . Hdl 1 oate JamJary 29, 1980 Subject Attached is a very rough draft of what I thought I might cover at our meeting with representatives of the neighborhood association in Oklahoma City on February 14. Please giv me any comments you may have, but I'd specifically like your though ts on the following: * j- 1) r this too much detail or not enough? J ^ C r--1 "fa 0 2) Si ould we address the question of mutagenicity/teratogenicity? Please resp ond as soon as possible, but I need your input at least by Friday, Fet ruary 1. J. J. Hall JJH :ajo Distributic n: R. E. Lei mkuhl Norm Fro t A1 Amsder J^hn Fri e nd ^6ill Bro ddle SAL 000103299 DRAFT #1 1/28/80 IN 191L THE B.F. GOODRICH COMPANY ANNOUNCED THAT THE PLANT PHYSICIAN AT ITS LOUIS VILLE, KY PVC PLANT HAD IDENTIFIED THREE CASES OF LIVER CANCER AMONG LONG-1 ERM PLANT EMPLOYEES. THE COMPANY SAID IT SUSPECTED THAT VINYL CHLORIDE MOt1 OMER (VCM) MIGHT BE IMPLICATED IN THE THREE DEATHS. THIS Af' NOUNCEMENT BY BFG TRIGGERED ONE OF THE MOST INTENSIVE INVEST1GATIC NS IN THE HISTORY OF OCCUPATIONAL HEALTH. IT BECAME THE TOPIC OF HUNDREDS OF MAGAZINE AND NEWSPAPER ARTICLES, TELEVISION SPECIALS, AND SPECIAL MEDI CAL CONFERENCES. VCM HAS BECOME ONE -OF THE MOST STUDIED CHEMICALS FF OM A TOXICOLOGY STANDPOINT. I WANT TO DISCUSS WITH YOU SOME CONCEPTS OF TOXICOLOGY IN GENERAL, AND THEN MOV E INTO SPECIFICS REGARDING VINYL CHLORIDE AND POLYVINYL CHLORIDE. FINALLY, I'C LIKE TO ANSWER ANY QUESTIONS YOU MIGHT HAVE. I OFTEF' GET ASKED QUESTIONS LIKE "WILL THIS STUFF HURT YOU" AND I ALWAYS FEEL UNCOMFORTABLE BECAUSE I KNOW THE PERSON ASKING THE QUESTION IS LOOKING FOR A STRAIGHT ANSWER: YES OR NO. BUT THAT'S A QUESTION WITHOUT A DIRECT ANS WER. YOU CAN SAY NO, IF ..., OR YOU CAN SAY YES, BUT ..., AND SPEND THE NE XT 20 MINUTES QUALIFYING YOUR ANSWER. BUT THERE ARE GOOD REASONS FOR SOUNDING EVASIVE WHEN YOU TRY TO ANSWER SUCH A QUESTION. SO ... BEFORE WE ST ART TALKING SPECIFICALLY ABOUT VCM & PVC I'D LIKE TO GIVE YOU A SHORT COURSE IN TOXICOLOGY SO THAT YOU'LL UNDERSTAND WHY ANSWERS MUST BE COMPLEX. TOXICOLOGY TOXICOL 3GY BEGAN, AS YOU MIGHT SUSPECT, AS THE STUDY OF POISONS. AS A MATTER OF FA IT, THE ROOT WORD TOXON - REFERS TO BOWS & ARROWS. ID- SAL 000103300 PAGE 2 TOXIKON - WsON ARROW TOXOLOGY - -STUDY OF BOWS & ARROWS ONE OF THE EARLIEST PRACTITIONERS OF TOXICOLOGY ( IN THE 16TH CENTURY) WAS THEOPHRPIS TU5 BOMBASTUS VON HQHENHEIM (ALIAS PARACELSUS). HE IS REMEMBERED (BY SOME, AT LEAST) FOR HIS RECOGNITION THAT ... "ALL SUBSTANCES ARE POISONS. THERE IS NONE WHICH IS NOT A POISON. THE RIGHT DOSE DIFFERENTIA1 ES A POISON AND A REMEDY." ANOTHEF WAY OF STATING THAT, AS EXPLAINED,BY PROFESSOR EMIL MRAK .SPEAKING BEI ORE THE, u:s. CONGRES^ONCERNIFrTtHE SAFETY OF PESTICID^ ___ CHEMICALS: " THERE ARE NO HARMLESS SUBSTANCES; THERE ARE ONLY HARMLESS WAYS OF usir G SUBSTANCES". ALL OF THIS LEADS US TO A BASIC PREMISE OF TOXICOLOGY, THE CONCEPT OF THRESHOLD. ALL CHI MICALS PRODUCE A RESPONSE (E.G. TOXICITY, IRRITATION, SENSITIZATK N, NAgCOSTS) AT SOME LEEVVEELL*. BUT, A LEVEL EXLSTS FOR ALL SUBSTANCES 'OR WHICH NONRRESPONSE MAY BE EXPE-f La EXAMPLE: S ORY ON WATER 6 WHAT I M WORKING TOWARD HERE IS THE CONCEPT OF DOSE - PROBABLY THE LEAST UNDER TOOD CONCEPT IN TOXICOLOGY BY THOSE NOT TRAINED IN THE FIELD. DOSE I ; THE AMOUNT OF MATERIAL REQUIRED TO PRODUCE THE DESIRED AFFECT. WHEN YtUR DR. TELLS YOU TO TAKE TWO ASPIRIN & GO TO BED, HE HAS A ' >)[,t REASON. IF HE TOLD YOU TO CRUMBLE ONE ASPIRIN & TAKE JUST A PINCH OF THE v i:A rPOWDER, IT WOULDN'T CURE YOUR HEADACHE. IF HE TOLD YOU TO TAKE THREE BOTTLES^ i ^j OF ASPIRIN, IT MIGHT HAVE DRASTIC EFFECTS. --& SO IT flAKES SENSE THAT AS YOU INCREASE THE DOSE YOU INCREASE THE RESPONSE .. THIS A .L LEADS US TO THE DOSE/RESPONSE CURVE. 4 > ,0 L. (/\-->.- --' Jy u-Tvu A ?/ (T) . Jr** - \ yrt ! 'A &AL 000103301 PAGE 3 {DRAW E (AMPLE ON BOARD) DISCUSS EXAMPLE LD >0 LD 0 CAN BE USED FOR OTHER RESPONSES ROUTE OF EXP DSURE INHALAT [ON/DERMAL/ORAL DIFFERENT EFFECTS --H2O LEAD CHROMATE ACUTE VS CHR 3NIC EFFECTS BEST WAf TO DESCRIBE: EXAMPLE OF ALCOHOL ACUTE EFFECTS: DRUNKEN STUPOR UPSE1VST0MACH BLURRED VISION NAUSEAy GIDuEYNESS _LACJU3F BALANCE EUPHORIA HEADACHE CHRINIC EFFECTS: (^LiyE^ INCREASED AGING ADDICTION TOXICITY f HAZARD TOXICITY INHERENT PROPERTY OF THE COMPOUND LD 50, CATALOG OF ADVERSE EFFECTS HAZARD L IKELIHOOD OF EXPOSURE IS CONSIDERED (EXAMPLE: BLOCK OF LEAD, N2) LIKE MANY SUBSTANCES, VCM HAS BEEN KNOWN FOR YEARS TO HAVE SOME TOXIC PROPERITIES. BUT PRIOR TO 1974 IT WAS CONSIDERED TO BE A RATHER INNOCUOUS CHEMICAL. I|T WAS KNOWN AT EXTREMELY HIGH CONCENTRATIONS TO BE AN ANESTHETIC, IN FACT IT WAS ACTUALLY USED AS AN ANESTHETIC FOR A WHILE. THE FIRST INKLING OF A POTENTIAL CHRONIC PROBLEM WAS A 1949 STUDY OF WORKERS IN A RUSSIAN PLANT. HEPATITUS WAS SEEN. BUT IT WAS CONCLUDED THAT A PCB PLASTi:iZER WAS PROBABLY THE CULPRIT. V- SAL 000103302 PAGE 4 IN 1961 A STUDY BY THE DOW CHEMICAL COMPANY ON LABORATORY ANIMALS SHOWED SLIGHt LIVER DAMAGE AT 100 PPM BUT A SIMILAR STUDY AT YALE FOUND NO CAUSE FOR CONCERN. 1 TO 1970 THERE WAS A RECOMMENDED STANDARD DEVELOPED BY A fRTS OF 500 PPM FOR WORKER EXPOSURE. WHEN THE OSHACT WAS PASSED IN 19 0 THIS CONSENSUS STANDARD WAS ADOPTED AND MADE INTO LAW. (STOP AND DI CUSS PARTS PER MILLION.) IN 1966 A REVERSIBLE DISEASE OF THE BONES OF THE FINGERS CALLED yc ACROOSETEOLYS IS WAS DISCOVERED AMONG SOME HEAVILY EXPQSED^REACTOR CLEANERS. THIS DI JCOVERY TRIGGERED RESEAPXH PROJECTS IN BOTH THE UNITED STATES AND EUROPE III AN ATTEMPT TO DISCOVER THE EXACT CAUSE OF THE DISEASE. A LEADIN G EUROPEAN PVC PRODUCER, REPORTED AT THE 10TH INTERNATIONAL CANCER CONGRi: SS IN HOUSTON IN MAY 1970 THAT HE HAD BEEN ABLE TO PRODUCE CANCERS. (BUT NOT ANGIOSARCOMA) IN TEST ANIMALS AT EXTREMELY HIGH LEVELS (10,000 TO 30 ,000 PPM) OF VCM EXPOSURE. DR. VIOLA'S FINDINGS WERE SUBSEQUENTLY PUBLISHED IN THE JOURNAL OF CANCER RESEARCH IN 1971. THE PVC INDUSTRY BEGAN PLANS FOR MORE EXTENSIVE ANIMAL STUDIES AT LEVELS OF EXf> OSURE MORE LIKELY TO BE ENCOUNTERED IN ACTUAL PLANT SITUATIONS EPIDEMIOLOGI AL STUDIES OF PLANT WORKERS WERE ALSO PLANNED. AN ANIMlL INHALATION STUDY WAS CONDUCTED UNDER THE DIRECTION OF DR. CESARE MALTON I OF ITALY. IN THE JNITED STATES THE CHEMICALS MANUFACTURERS ASSOCIATION IN JUNE 1973 ANNOUNC ID THAT 17 PVC PRODUCERS HAD AGREED TO SPONSOR A STUDY OF ALL CAUSES OF DE \THS IN VINYL CHLORIDE WORKERS. IN FEBRUARY 1973 THE INDUSTRY ALSO CONTRACT ED FOR LIFETIME CHRONIC INHALATION STUDIES USING TEST ANIMALS. SOME PR ELIMINARY RESULTS OF DR. MALTONI1S STUDY BECAME AVAILABLE IN EARLY 1973. DR. MALTONI HAD DETECTED A VARIETY OF TUMORS IN TEST ANIMALS AT CONCENTRAIT IONS AS LOW AS 250 PPM. PAGE 5 THEN .. IN JANUARY 1974, B.F. GOODRICH NOTIFIED GOVERNMENT OFFICIALS REGARDING THfl THREE ANGIOSARCOMA DEATHS. AFTER A SPECIAL "FACT-FINDING" HEARING HELD IN FEBRUARY 1974, OSHA PROMULGATED AN EMERGENCY TEMPORARY STANDARD WHICH LOWERED THE MAXIMUM VCM WORKPLACE EX OSURE FROM 500 PPM TO 50 PPM. ON MAY 0, THEREFORE, OSHA PROPOSED A PERMANENT WORKER STANDARD WHICH WOULD REDCUE IN-PLANT EXPOSURE TO THE "NO DETECTABLE LEVEL" AND REQUIRE COMPLETE IMP :RVIOUS SUITS AND SELF-CONTAINED BREATHING EQUIPMENT. PUBLIC EARINGS, UP TILL THEN THE LARGEST EVER HELD BY OSHA, BEGAN IN WASHINGTO ON JUNE 25. AT THIS HEARING,OSHA HEARD EVIDENCE PRESENTED BY REPRESENTATIVES OF LABOR, GOVERNMENT, PUBLIC INTEREST GROUPS, SCIENTISTS AND ENGINEERS. AFTER WEIGHI G ALL THE EVIDENCE, OSHA PUBLISHED A PERMANENT STANDARD OF 1 PPM AVERAGE ALLOWABLE WORKER EXPOSURE WHICH WENT INTO EFFECT ON APRIL 1, 1975. INDUS RY WIDE COST OF COMPLIANCE RAN BETWEEN $300 AND $400 MILLION IN CAPITAL EXPENDATURES PLUS YEARLY OPERATING EXPENSES. THE CONOCO PVC PLANT IN OKC HAS SPENT APPROXIMATELY TO REACH COMPLIANCE WITH THIS STANDARD. EPA INVEST!! ATIONS AT THE SAME TIME THE OSHA STANDARDS WERE BEING HAMMERED OUT, THE ENVIRONMENT/ L PROTECTION AGENCY (EPA) BEGAN INVESTIGATIONS INTO WHETHER VCM CONSTITl TED A HAZARD TO THE HEALTH OF PERSONS LIVING IN THE VICINITY OF PVC PLANTS. AN EPA TASK FORCE, ESTABLISHED IN FEBRUARY 1974, DETERMINED THAT THERE ,, ------------<// (Vr,- K WAS "NO SCIENTIFIC EVIDENCE TO INDICATE THAT THESECEMISSIONS) POSE AN ' V . | IMMINENT HAZARD TO PEOPLE LIVING NEAR THESE PLANTS ..." 1 NONETHELESS, THE EPA SAID IT WOULD PROPOSE REGULATIONS TO REDUCE VCM EMISSIONS DRASTICALLY FROM 1974 LEVELS. Sfti OOOx 033o4 PrnflOftFL f0i ERA'S :NVESTIGATIONS INTO VINYL CHLORIDE RESULTED IN THE PUBLICATION OF FOUR MAJ )R DOCUMENTS ON THE SUBJECT: (1) A. 67-PAGE PRELIMINARY ASSESSMENT )F THE ENVIRONMENTAL PROBLEMS ASSOCIATED WITH VINYL CHLORIDE -- SEPTEMBER 1 )74, (2) A SCIENTIFIC AND TECHNICAL ASSESSMENT REPORT ON VINYL CHLORIDE AN ) POLYVINYL CHLORIDE -- JUNE 1975, (3) A QUANTITATIVE RISK--^ ASSESSMENT :0R COMMUNITY EXPOSURE TO VINYL CHLORIDE - DECEMBER 1975, AND (4) AN EXTE 1SIVE TWO VOLUME STANDARD SUPPORT AND ENVIRONMENTAL IMPACT STATEMENT - - SEPTEMBER 1976. THE AG :NCY ALSO OFFERED INTERESTED PARTIES THE OPPORTUNITY TO MEET WITH EPA OF :ICIALS TO DISCUSS PROPOSED METHODS OF CONTROLLING VCM EMISSIONS. AFTER 12 MONTHS OF EXTENSIVE STUDY AND DISCUSSIONS, THE AGENCY OFFICIALLY PROPOSED ON DECEMBER 16, 1975, A STANDARD REGULATING EMISSIONS OF VINYL CH .ORIDE INTO THE AMB'IENT AIR. A PUBLIC HEARING WAS HELD IN FEBRUARY 19 76. THE OFFICIAL RECORD OF THE AGENCY1S INVESTIGATION OF VINYL CHLORIDE LI STED 699 DOCUMENTS TOTALING SOME 9,000 PAGES. IN OCT )BER 1976, AFTER MORE THAN TWO AND A HALF YEARS OF INTENSIVE INVESTIGATI 3N EPA PROMULGATED NATIONAL EMISSION STANDARDS FOR VINYL CHLORIDE GAS AND PVC RESIN PLANTS. THE EP 4 STANDARDS REDUCED EMISSIONS BY APPROXIMATELY 95 PERCENT FROM / 1974 LEVELS . THE STANDARDS WOULD THEORETICALLY REDUCE THESE EXPOSURE LEVELS FROM APPROX IMATELY 17 PPB (STOP AND DISCUSS PARTS PER BILLION) TO LESS THAN ONE PPB AS 4 YEARLY AVERAGE. BASED ON EPA1S OWN CALCULATIONS, THIS COULD p , RESULT AT A MAXIMUM IN APPROXIMATELY ONE CASE OF ANGIOSARCOMA EVERY TWO YEARS AMONG THE FIVE MILLION PEOPLE LIVING IN THE VICINITY OF THESE PLANTS, f CONSIDERED S THAT MORE THAN 80,000 OF THESE PEOPLE COULD BE EXPECTED TO DIE FROM OTHER CAUSES DURING THAT SAME TWO-YEAR PERIOD, THE THEORETICAL ONE ANGIOSARCOf- A CASE WAS CONSIDERED AN ACCEPTABLE RISK BY EPA, SAL 00010330 PAGE 7 LET ME )IGRESS FOR A MOMENT AND DISCUSS THAT TERM "ACCEPTABLE RISK". IT'S IMPORTAH T THAT WE UNDERSTAND THAT THERE IS NO SUCH THING AS ZERO RISK. ALL HUMAN ACTIVITIES FROM GETTING OUT OF BED, TO TAKING A SHOWER, TO DRIVING A CAR INVOLVE SOME AMOUNT OF RISK. EVEN NOT GETTING OUT OF BED INVOLVES RI5 l(\ SO WHETH ER WE DO IT CONSCIOUSLY OR NOT, WE ARE CONSTANTLY CHOSING TO PARTAKE IN A rriVITIES BECAUSE WE JUDGE THE RISKS TO BE ACCEPTABLE. LET ME GIVE YOU SOM I EXAMPLES OF SOME EVERYDAY RISKS THAT HAVE BEEN QUANTIFIED: INDIVIDUAL RISK OF FATALITY MOTOR VEHICLE FALLS FIRE AIR TRAVEL LIGHTNING 300 CHANCES/MILLION 90 CHANCES/MILLION 40 CHANCES/MILLION 9 CHANCES/MILLION A T 1' / V" & j ^ f; H: O' h CHANCE /MILLION ALL CANCER VINYL CHLORIDE 3000 CHANCES/MILLION ____________ 1/1/CHANCE /MILLION 70 VS 55 MPH 50 CHANCES/MILLION IF WE C ^ N ASSIGN MATHEMATICAL VALUES TO RISK, IT FOLLOWS THAT WE CAN COMPARE RISKS WHICH ARE ROUGHLY EQUIVALENT. GETTING BACK TO THE SUBJECT AT HAND, PRO :ESSOR RICHARD WILSON OF HARVARD UNIVERSITY HAS CALCULATED THAT THE RISK OF -IVING WITHIN FIVE MILES OF A PVC PLANT FOR ONE YEAR IS EQUIVALENT T ) THE RISK OF CONTRACTING CANCER FROM EATING 1/2 TABLESPOON OF PEANUT BUTTER , OR TO THE RISK OF CONTRACTING CANCER FROM THE INCREASED COSMIC RADIA ION DURING A THREE-DAY VISIT TO DENVER, COLORADO, OR TO THE HAZARD FROM WOKING 1/15TH OF A CIGARETTE. GETTING BACK ON TRACK ... IN NOVEMBER 1976 THE ENV RONMENTAL DEFENSE FUND FILED SUIT IN THE COURT OF APPEALS IN WASHINGTON CU ALLENGING THE EFFECTIVENESS OF THE STANDARD. 0001033* PAGE 8 THE EDI AND EPA NEGOTIATED IN PRIVATE MEETINGS FROM WHICH THE X \ INDUSTRY WAJ EXCLUDED. ALTHOUGH AN EVENTUAL RULING BY THE COURT THAT INDUSTRY RE IfRESENTATIVES HAD A LEGITIMATE RIGHT TO INTERVENE IN THE CASE. THE RE ULT OF THOSE SECRET NEGOTIATIONS WAS A FORMAL AGREEMENT ON MARCH 24, 1< 77, BETWEEN EPA AND EDF TO PROPOSE AMENDMENTS TO THE EXISTING, VINYL CHLOR DE STANDARD WHICH HAD BEEN PROMULGATED ONLY FIVE MONTHS PREVIOUSLY. THE PROPOSED AMENDMENTS WERE PUBLISHED IN THE FEDERAL REGISTER ON JUNE 2, 1977. THE AGE NCY HAD RECEIVED OR OBTAINED NO NEW MEDICAL OR TECHNICAL INFORMATION THAT WOULD JUSTIFY ANY CHANGES IN THE STANDARD. USING METEOROLOGICAL'READINGS PLUS SOPHISTICATED COMPUTER PROGRAMS, IT WAS ESTAE} LISHED THAT THE ORIGINAL EPA ESTIMATE OF 17 PPB OF VINYL CHLORIDE AS A YEARLY AVERAGE EXPOSURE WITHIN FIVE MILES (NEAR) OF UNCONTROLLEE VINYL CHLORIDE INSTALLATIONS WAS FAR TOO HIGH. ___ INSTEAE IT WAS DETERMINED THAT MEAN VINYL CHLORIDE CONCENTRATIONS ON, -x THE ORDER OF 2.5-4.5 PPB FOR EACH UNREGULATED PLANT ARE REDUCED TO CONCENTRATIt NS ON THE ORDER OF 0.15-0.25 PPB WHEN IN COMPLIANCE WITH EXISTING ST/ NDARDS. SEVERAl EXPERTS HAVE VOICED OPINIONS REGARDING ACCEPTABLE AMBIENT CONCENTRATIC NS OF VINYL CHLORIDE. DR. CARLO TUMBURRO, DIRECTOR OF A V\Yr' A'* h, - vVC RESEARCH PROGRAM AT THE UNIVERSITY OF LOUISVILLE MEDICAL SCHOOL, DR. ; 0 CHARLES SHAl , CHIEF OF THE MEDICAL GENETICS SECTION OF MD ANDERSON AND 0 x \ , ,rxf ' , DR. MITCHELL ZAVON, PROFESSOR OF INDUSTRIAL MEDICINE AT THE UNIVERSITY \</ OF CINCINNA1 I HAVE ALL STATED THAT CONCENTRATIONS OF VC ON THE ORDER 0F_^ 10 PPB SHOUL D BE SAFE FOR HUMAN EXPOSURE. ONE LAS T POINT: I MENTIONED THAT THE EPA ESTIMATED THAT AM AMBIENT LEVEL COMPL] ANCE WITH ITS STANDARD COULD RESULT AT A MAXIMUM OF ONE CASE SAL 000103307 PAGE 9 OF LIVER CA 'IICER EVERY TWO YEARS IN AN EXPOSED POPULATION OF 5 MILLION. ANGIOSARCOMA IS CONSIDERED A VERY RARE FORM OF CANCER. THE NATIONAL AVERAGE IS )NE CASE PER 78,000 DEATHS. OUT OF A POPULATION OF 5 MILLION YOU WOULD E (PECT 80,000 DEATHS FROM ALL CAUSES IN TWO YEARS SO AN INCIDENCE 0 : 1 CASE OF ANGIOSARCOMA EVERY 2 YEARS IS NO MORE THAN WOULD BE EXPECTED TO OCCUR NATURALLY. SAL 000103303 lorfde and polyvii yl-cEldBde^g^coi flreLm' , /expected to spend i sVeral days trying! " `i>pinpoinf'thS cause t f ,the'blast ^Cu- GU<?C k l /^A <teJ,, em m>i exploded,' Kridt klngJowri oS,ott y tj-in' c<r'ewte' w.;*;?a,R4s^*voi`it.-rsv* r.riir"**&s* It was i bt immediately; c .mafiy(,of the . -. nbers were" toy ^^;^h^fai}in,ed|mer local rnwwtal w!thc* Deputy Fire Chef James Kean. . .automatic sensing devices at the plant _ deteefced'leaking g is^shortly after.Tjr.m. Friday* He and ither firefighters re* __ sponded^aucf sa^ "thick; heavyiwhitr , `dense cloud lying i ear the ground""when they arrived at the plant. SAL 001032 90