Document ppgkQLg99NoZZOxeNzQrakN5B

R&S 108252 r V BIO-MEDICAL RESEARCH DOCUMENT DESCRIPTION FORM 63 68 69 76 Duplicate in all cards:-- year as-1961- File number [Right justify [Numeric only] Author(s), as Last Name FS (No Punctuation) and coden for journal as JAMA preceeded by one blank space 1 20 21 XHrirr}.i~ (3 40 41 77 78 \UJL, Sub-Index Code 60 61 62 Title of Report; end with space-hyphen-hyphen-space. Follow with Index Terms, separated from each other with comma-space. Avoid other punctuation; do not abbreviate. 1 2 ______ ,________________________ a____________ _______._________ { / ( sk!'/> a (dcS LUo-t-e*. .. h,, 61 62 21 -tt^T ~T)ejthz, fX /?/-//C_Jp R )------------ 22 Csfl/fL A/3 //X ^ / /:// 23 24 Source (Journal, Vol., Number, Pages, Date ) 12 LVilII Dot !j (j. aJ) ^hj-/sr \ JoLL-i-n cl. 1 COox. a /<??ljl 61 62 Brief Summary 12 10 SUMMARY: 61 62 61 62 63 64 ~f' "* Langner, R. R. , 607 Oelfkc, K. H., Freeport Rausch, D. A., 2020 Roberts, D. J., 2030 Blair, E. H., 2020 Gehring, P. J., 1803 Hoerger-, F. D., 9008 Rowe, V. K., 1803 R. R. Cook, 607 R. Daniel, Freeport L. Adcock, Plaquemine R. Oubre, Oyster Creek K, Burgess, 2040 H. R. Hoyle, 1707 J. Strasser, 1604 OOOOjgt from: THE WALL STREET JOURNAL, WEDNESDAY, OCTOBER 2, 1974 T.R, Torkelso-] 10/2/74 VOL. LIV NO. 440 if -jV midwest Emtio.'.' Health Hazards Vinyl-Chloride Risks Were Known by Many Before First Deaths Hindsight Shows Weakness InF`inns' Systems Aimed At Protecting Workers The Tip of a Large Iceberg By Barry Kramer Staff Reporter of The IV.iu, Sthiikt JornND, A few weeks before Christmas in 19-18, Earl Parks, then 26 years old, signed on as a helper-trainee at the large B. F. Goodrich: Co. plastics factory in Louisville, Ky. The: plant had been making polyvinyl-chloride plastic from vinyl-chloride gas since before! the war, using a process developed by Good-i rich in 1937. It was a growing Industry that Mr. Parks' Joined, Polyvinyl chloride-dubbed PVC forj short--had found special, but limited, appli-l cations in the war years, especially as a fireproof coating for electric wiring in fighter planes and ships. But in the late 1910s, so-called vinyl consumer products, made from PVC, began coming into vogue; and by the time the 1950s were under way polyvinyl-chloride products such as contain ers, phonograph records and curtains were staples in American households. The basic Goodrich process, still in use today, pipes vinyl-chloride gas into large re- This is the first of tiro stories con* cr.rninu tw/ilicntions of the discuvtiy that vinot chloride con cnii.se cnnccr. actor vessels; there, the gas is agitated to gether with a liquid and catalysts. The pro cess causes polymerisation, a linking to gether of the molecules of the gas (a mon omer) into the long chains that give PVC (a polymer) its strength and oilier desired characteristics. Tiie First Years In his first years with Goodrich, it was Earl Park's job to crawl inside the reactors after each batch of PVC was drained off and to chip away that portion of the poly mer that had congealed. During the hourlong task, repeated several times in the : course of an eight-hour shift, Mr, Parks and other workers who performed the same function would unavoidably Inhale ttie heavy, sweet-smelling fumes of vinylchloride gas that had escaped polymeri; ration. f As the 1959s went by and the 1960s began, Earl Parks was working his way up to the job of foreman, a post that he had attained 1 by the time that ill health forced Iris early retirement In the late 1960s. In the years that ho had-worked with Goodrich, the PVC industry flourished as thousands of new uses were discovered for the polymer. On March 3, 1973, at the age of 50, Earl Parks died of angiosarcoma of the liver, a , (type of cancer that is invariably fatal. His ! death attracted scant public attention at the lime, but today the significance of Mr. i Park's illness is unquestionable and shatter; ing in its implications. For Earl Parks came to be one more statistic in turning a hypoth esis into a reality: Vinyl chloride can cause cancer. Deadly Statistics __ The ' link between angiosarcoma and vinyl chloride is further buttressed by other deadly statistics. Seven of Mr. Park's fellow workers at the Goodrich plant also con tracted the disease, and five have died. In all, there have been 16 documented angios arcoma cases in the U.S. in recent years, all of them linked to vinyl chloride. In addition, 10 other cases have been reported in Eu rope. While tiie total number of rases is small, the industry has been shaken to its roots. The disease now is known to work insidi ously, slowly, during decades of exposure, the implications being that the cases thus far are quile likely only the lip of an ice berg. Nine companies, with It plants and 910 employes, currently produce vinyl elder- ide monomer from ethylene, a petrochemi cal, The monomer, in turn, is used by 21 companies operating 36 major plants and employing 5.000 workeis, to make more Ulan five billion pounds of PVC normally. (World-wide production is some IS billion pounds annually.) , Even the five billion pounds of PVC an-' nually produced in this coimhy isn't enough, to meet the domestic demand for tiie plasin-1 into which rVC is formed. From 3,000 to 4,000 processors, employing an estimated 700,000 workers, fabricate the plastic into a wide variety of products ranging from vinyl floor tiles to shower curtains. According to a study done for the Society of tiie Plasties In dustry by Arthur D. Little Inc., as many a.-, 2.2 million jobs depend on polyvinyl-chicuide, plastic. If PVC were banned, the study says, the annual loss to industry in sales and pro duction would be some 563 billion to 590 b.!-, lion. (The Manufacturing Chemists Associa tion estimates die wholesale annual value of all PVC products is $3 billion.) j Emergency Decree | At the moment, no one believes the in dustry will suddenly come to a screechr-g halt. However, after the first human cases' of vinyl chloride-induced angiosarcoma wove disclosed, the Labor Department's Oc cupational Safety and Health Administra tion imposed a temporary emergency stan dard for PVC factories; thenceforth, OSHA decreed, the permissible level of vinyl chlor ide in the air of such factories would be 59 parts per million. That level was far below- the industry standard, in effect for years, of 500 parts per million. i OSHA's emergency decree was made: last May. Since then, animal research found, that tumors develop at 50 parts per million, j Yesterday, OSHA issued a new permanent! standard requiring employers after Jan. 1.' 1975, to reduce exposure to one part per mil-! hon in factory air, averaged over eightU hours, and five parts per million averaged| over any period no longer than 15 minute-(See story on page J l.) While considerably more stringent than the emergency decree. Please Turn to Ptuje 1), Column 2 u fio C/> o 00 ro cn co -2- R&S 108254 `i Health Hazards; IVlany Ivnew rusksT ar i.I tT 1 AT T 7" *7 ! lticl;v occupational-health officials also \vcro_ i^'-mcci.-i.iacood.-ichmaaeiianrstpuw^ J announcement. Of Vinyl Chloride Before Deaths Almost since Its first commercial intro duction, there have been reports that vinyl chloride is toxic above certain levels. In deed, during World War II, vinyl chloride Continued From First Page surgeons, instead of finding an ulcer, found was rejected as a surgical anesthetic be the new permanent standard --particularly with its flvc-psrts-pcr-million provision and Its allowance o' averaging --nevertheless falls short of the "no delectable" limit advo cated by unions, many medical experts and such groups as the National Institute for Oc cupational Safety and Health, and the American Chemical Society. This no-detectablc limit would have constant, not average', adherence to onc-part-pcr-million levels. Therefore, it seems certain that the argu ment won't abate. As tile controversy continues, It is reveal ing to examine how the link between vinyl chloride and cancer was established. If nothing else, such an examination points out the grave weaknesses of the present system -- or lack thereof--of protecting workers and others from industrial hazards. The judgment is made in hindsight, but instead that Mr. Parks's problem resulted from severe liver damage, which had caused blood to back up in the portal vein leading into the liver. The surgeons cor rected the vein problem with a shunt and took a sample of liver tissue for analysis. The analysis showed that the liver had been damaged by exposure to `'chemicals.'' Can cer wasn't mentioned, (According to testimony at OSHA's hear ings on vinyl chloride, held last June and July, Air. Parks received a total of almost SG.000 in workman's compensation from Goodrich before he died, but only after Goodrich protested that his illness couldn't have resulted from exposure to the chemi cal.) It was an alert Louisville doctor who first marie the connection between angiosarcoma and vinyl chloride. Dr. John L. Creech, who cause animals developed heart irritation when exposed to it. In 19 !0, Russian scien tists reported "hepatitis-iiko changes" in the livers of 25% of the workers in a small PVC plant. Then, in the late 1950s; research toxicolo gists at Dow Chemical Co. showed that, ani mals exposed to as few as 100 parts per mil lion of vinyl chloride (or 100 molecules of vinyl chloride in every .one million mole cules of air) developed slight liver damage. Based on its research, Dow began a pro gram in the 19G0s to reduce the level of vinyl chloride monomer in the air of its plants to below 50 parts per million. Dow published its results in 1961. But the rest of the industry chose to rely on a Yale University study that recommended 500 parts per million as a safe level. This same level had been recommended by the Alanu- the history of vinyl chloride shows that evi dence of Its toxicity was often ignored. What's more, the chemical companies knew, but kept secret for at least six months, the fact that Italian researchers had shown that rats develop tumors, includ ing angiosarcoma, when exposed to low levels of vinyl chloride monomer, European companies, which paid for the animal re search, knew of these research findings for more than a year before the first human cases were reported but didn't reduce the exposure of thetr workers to vinyl chloride. But Dr. Irving J. Selikoff, dn expert on for years has treated workers sent to him by Goodrich on a fee-per-patient basis, had followed Earl Paries's case for some time, even though he wasn't treating Mr. Parks. Dr. Creech says lie had been concerned about an abnormally high number of Good rich workers who had liver disease. When ho heard that Mr, Parks had died, he re calls, he asked to see the'autopsy report. It was in August 1973 that Dr. Creech learned that Air. Parks had died the pre vious March of angiosarcoma of tile liver. The doctor says he then realized that some thing was seriously wrong, since another faeturing Chemists Association since 1951, was affirmed in 1962 by tho American Con ference of Governmental Industrial Hygien ists and was given the force of law by OSHA In 1971. However, evidence at the OSHA hearings indicates that this level was regu larly exceeded until this year in many plants. (The hygienists' group didn't recom mend lowering the level to 200 parts pe. million until 1972, four years after Dow con eluded from further tests that repeated ex posure by workers to vinyl-chloride mon omer at an average of 300 parts per million or above for a working lifetime could cause environmental carcinogens, or canccr-eaus- Goodrich PVC worker, a private patient of changes In the liver.) ^ ing agents, claims that blame shouldn't bo Dr, Creech, had succumbed to the same Another Iliscaso placed at industry's door alone. "We're all a type of cancer in 1971, Dr. Creech says he During the 1060s, there were reports of a bit responsible," he says. "None of us did knew that liver angiosarcoma, is exceedingly disease called acroostcolysis among vlnyl- our homework." Culpability, he says, should rare and that two cases among such a small ehloridc workers. The disease consists of be shared by scientists, government agen plant population was abnormal. (In fact `skin lesions and changes In the blood ves cies and labor unions. medical men estimate that fewer than CO sels, leading to degeneration of tho bones at The ease of Earl Parks is illustrative. cases occur each year in the U.S, striking the tips of the fingers and toes in those ex Mr, Parks first came to the attention of only one in 9C0.CC0 persons.) posed to high levels of the monomer. (Emis Goodrich medical people in 10GI, when the Dr. Creech met with Goodrich's occupa sions of vinyl chloride are generally lower company, concerned about the known liver tional health director, Dr. Maurice N. John-'nt plants where tho monomer, or gas. is toxicity of ethylene dichloride (a chemical son, who subsequently decided to ask Tubcr-j made, since the process is less complex, from which vinyl chloride is made) tested shaw-Cooper Associates Inc., a Berkeley,!nnd there is less chance for leaks than at the liver function of workers in the Louis Calif., epidemiological-studies concern, tojlhc polymerization plants; none of the ic- ville plant, do a survey of Goodrich death records. But;P0I'tcd angiosarcoma cases in this country Mr. Parks's readings were abnormal. the study was hardly needed; on Doc. 19, aihas occurred among workers making vinyl- Nevertheless, he continued to work at the third PVC worker at the Louisville plant! chloride monomer, and only one of the 10 samo Job. In October 10Gt, however, he was died at the age of 58; he had been at the!deaths in Europe was in a monomer plant.) hospitalized will: what was initially diag plant for 23 years. In early 1967, the Manufacturing Chem- nosed as a bleeding ulcer. Doctors treated i'uhlic Ami'imu-emcnt ints Association arranged with the Univer- the "ulcer'1 without surgery, and Mr. Parks On Jan. 22 of this year, Coodrlch officials^ily of Alichigan to study acroostcolysis was released. met In Washington with officials of the Ns-'among vinyl-chloride workers, particularly He was readmitted to the hospital the fol tional Institute far Ocupationul Safety and those who cleaned tho reactor vessels and lowing May, and the decision was made to operate. But when the operation was begun. Health and giosarcoma informed them of tho deaths. The following three an-jfthers who were exposed day, Ken- lions o( vinyl chloride in to large the air. TchoencMenictrheiI gan scientists reported in 1970 that although they couldn't pinpoint vinyl chloride 03 the cause o( the disease, worker exposure to the monomer should be cut to 00 parts per mil lion or below. -3- O'.ker than Dow, which had already Insti tuted reduction'! in nir level of the mon omer, the sest of the industry in tho U.S. ig nored the recommendation. Nor was there any significant reaction to findings by Euro pean industry that animals developed ad verse effects from vinyl chloride. This was at least partly because the Europeans down-j graded the Importance of some of their find-! Lags. For example, Prof, Pier Luigi Viola, aj medical director employed by Solvay &| Cic.. the Belgian chemicals company, found| jbonc changes in rats c.xposcd to air levels of,30,000 parts per million of vinyl chloride: even more important, he found that vinyl chloride at that level caused malignant tujmors in tho car canals, lungs and bones of rats. Prof. Viola reported his findings before 1 an international cancer congress in Houston in 1070. It was the first reported link be tween cancer nr.d vinyl chloride. Eut the professor expressed doubt about the purity of the vinyl-chloride gas he had used and stated that the rat cancer findings, because they occurred at such high levels of the monomer, had no human implications. (Prof. Viola subsequently found tumors in rats exposed to 500 parts per million; but this fact wasn't revealed until well after the ' first human angiosarcoma cases were re vealed.) The. Research Goes On Eased on Prof. Viola's early cancer find ings in rats, Montedison S.p.A., (he huge Italian chemicals company, in 1070 asked Ccsnre Mnltoni, a respected researcher at the Institute of Oncology in Bologna, Italy, to do more extensive animal studies. By Oc tober 1072. Prof. Mnltoni says, he had found that 250 parts per million of vinyl chloride produced tumors in rats in three parts of the body: the ear canals, kidneys and the liver. The liver tnmors included angiosar coma. The professor immediately informed his sponsors. Tlie Europeans offered their information to the Manufacturing Chemists Association in the U.S., but only if the Americans guar anteed. confidentiality. With great reluc tance, the association says, it finally agreed . to the secreey condition "because of the vital importance of learning of any indica tions from tho European research . . . with out the delays which could have resulted from duplication of effort." On Jan. 30. 1973. a year before the first human angiosarcoma, cases were reported by D. F. Coodrieh. tho MCA finally got the Mnltoni data. For five months, the secrecy restrictions were such that government agencies, TVC workers exposed to vinyl chloride and even company doctors were kept in the dark. Tiien, in the late spring, the Europc.nrs agreed that the Chemists As sociation rould prse tho information on to the u.S. Natinivit Institute for Occupational Safety and Health, the- Labor Department agency that monitor.! worker safety. On July 17. 1973 representatives of the associa tion ar.d the agency niet. . - One Certainty There is some, dispute as to what tran spired at the meeting. The Labor Depart ment agency claims it wasn't given the full story; the chemists' association claims that the agency misunderstood the findings. But one thing is certain: The agency, and OSHA, made no move to change the stan dard of 500 parts per million and didn't do so until after the human angiosarcoma cases were announced. In Europe, by con trast, Great Britain had lowered the maxi mum level to 200 parts per million following the cases of acroosteolysis in the '60s; and West Germany had sot a level of 100 parts per million in 1970. based on Dow's 1061 re sults with animals. According to New Scien tist, the British science journal. "No other section of the U.S.' or European industry fol lowed Dow's Irad. The reasons for this in ternational eonfusion arc obscure." This all changed quickly, of course, once the first human cases of angiosarcoma were reported by Goodrich. Indeed, the swiftness with which new research has been carried out since Jan. 23 is perhaps without prece dent in the world of medicine and science. lyiuch of this recent research is con cerned with studies of the incidence of dis ease of all types among vinyl-chloride work ers. Thus far, some studies show that work ers exposed to high levels of vinyl chloride show greater than expected incidences not only of angiosarcoma but certain other can cers as well. The ramifications of these find ings for the future of the Industry and its workers remain to be seen. However, for the veteran PVC workers, whatever changes the findings produce will be useless in counteracting the insidious effects of working day after day, year after year, in what now is generally viewed as a contami nated atmosphere. s gZ80V * THE WALL' STREET JOURNAL, WEDNESDAY, OCTOBER 2, 1974 *** Vinyl cliloritlc levels in (lie air workers breathe must be reduced sharply, the Labor Department or dered. Tlie ruling for the pas, which has been linked to liver cancer, brought a suit from the plastics in dustry and protests from organized labor. (Sfory on Page 14) *** ----------------- ----------- ---------------------------------------------- ~i * -------- Sharp Drop in Vinyl Chloride Exposure Is Ordered by Labor Agency for Workers, Hi/ r Walt, Ftheet Juer.xAL Staff Ileiwtcr WA SHINGTOX--Tlic Labor Department Ordered a sharp reduction in workers' expo sure to vinyl chloride, a widely used indus trial pas that lias been linked to liver can cer. Tne ruling, which comes after nine months of controversy, brought a lawsuit from tile plastics industry, which contends the standard can't bo met. and protests from organized labor, which contends the rule lias loo many loopholes. Vinyl chloride is a basic ingredient in making many every day plastic products. Tim new standard, issued by the Laber Department's Occupational Safety and Health Administration, requires that, start ing Jan, 1, vinyl chloride levels int he air that workers breathe bo held to one part vinyl chloride per million parts of air, aver aged over an eight-hour period. Actual levels may exceed one part per million for short periods, but they must average out to no more than five parts per million for any 15-minute period within the eight-hour time span. Since last April, companies handling vinyl chloride have been under an emer gency restriction of 50 parts per million, without any time period. The emergency standard was issued after the discovery, beginning last January, of cases of a rare and fatal liver cancer, an giosarcoma, amen workers exposed to vinyl chloride. Nineteen deaths among such workebs in the U.S. and oilier countries have been attributed to liver cancer caused by long exposure to the chemical. Vinyl chloride is a gas that is processed to form a powdery .instance known ns poly vinyl chloiide. Polyvinyl chloride. In resin or pellet form, i; then fnbi,icatril into a wide vancty of finished plastic products. Coverage for Workers r- Though only about 6,500 workers arc em ployed in plants that make vinyl chloride and polyvinyl chloride, about 550,000 others, who work m facilities that create finished I products from the rolyvinyl chloride, will | also be covered by the new ruling. Workers : who handle only finished products, and don't jhave any chance of contact with "raw" jvinyl chloride or polyvinyl chloride, are the Despite this attempt at compromise, however, the Society of the Plastics Lndustry and some producers sued the Labor De partment to overturn the ruling only mo ments after it was issued yesterday. And Firestone Plastic Co., a unit of Firestone Tire & Rubber Co., said it will ask a court to stay enforcement Of the standard while the suits arc being tried. jOnly ones exempted. Ralph Harding, president of the industry I The Labor Department initially proposed group, said the standard is "unrealistic, !|that exposure be limited to "no detectable probably will be impossible for most, if hot ijlcvcl," without any averageing over time. all, of the industry to meet and appefuflta 11TliIs proposal pleased organized labor and have been developed on some basis incij^^^ j some key researchers in the field of occupa tent with recorded facts." Tile job-s^Sr tional health. Eut the Society of the Plastics agency "may believe that it has adopted a II Industry, a trade group, and many compa- compromise position," but the result is un 5'nics using the chemicals, denounced It as acceptable to the industry, he added. .technologically impossible and warned it Todd C. Walker, president of the Fire ; would drive the industry out cf business. stone unit, asserted that the standard "puts J In selecting as its final standard one part the vinyl plastic industry on a collision i'per million over eight-hours and five parts course with economic disaster." He said it yper million over 15 minutes, the department "is comparable to a law aimed at stopping ' apparently was trying to rcacli a cornpro- automobile deaths by lowering the speed '(!misc between its original idea and the limits to one mile per hour." l toughest proposal offered by the industry, 'j which would have left exposures as high as 1110 parts per million in some plants and 25 i parts per million in others. Discretion in Enforcement Tie department sought to smooth further the adjustment for industry by delaying until next January the drop from the pres ent 53 parts per million. Also, it gave its on| forcemeat staff discretion to determine-how i the companies must meet the standard. 'While the goal is to reach the new levels through "engineering and work practice .controls," such controls must be deemed "feasible," and companies can deal with any exposures produced by inadequate con trols by giving workers respirators. A date wasn't set in the ruling for im proving ]'I.itit engineering and prnctires to .the point where respirators won't be needed. Wind's more, until January 137G workers 'may refine to wear ihe rc-pirators when ex posures don't exceed 25 parts per million, even if they exceed Hie one part per nullum over eight hours specified in the regulation. R&S 108256