Document dQEK4OLkd2RR4vzoQD00QBrbe

R&S 111774 BIO-MEDICAL.RESEARCH DOCUMENT DESCRIPTION FORM 63 68 69 76 Duplicate in all cards: --> | UU0U335 year as-1961- File number [Right justify [Numeric only] 77 78 !/& Sub-Index Code Author(s), as Last Name FS (No Punctuation) and coden for journal as JAMA preceeded by one blank space 1 20 21 _________________ 40 41___________________________ 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; ,, Cf.do not abbreviate. 77/a--T7fA?&r/r*sp r//r Ztrfrw*- 0 /ft'y irK Ay'/fxxc.. 21 22 23 24 Source (Journal, Vol., Number, Pages, Hate) ^ tlx 2* rf/V ^ rr___Pf erg * t' ' y.y, 61 62 31 32 Brief Summary 12 10 SUMMARY: 61 62 61 62 63 64 R&S 111775 From J. TRAVIS SEAWELL $e+-r Serf?S tttittJi -* /0*A dofttyr +&* khjd+n* ca* v&rs-*/o*>. Dtlhio ' /** A/orwJf /rnimtr Stror* t*' .orAoto M/OiK+A Jtos? StAAtnifmi /** & JrSattA'fr School *- *e "Artrr eUf***>+( T e*/4/ 4*r it o*t eJ&rf yk SrOwie A*4v * jP*>&JiC?A**o 0/ "Pro/rdy %? JJ VK ". ^ hi z-- l>eerf *3***/ da&fr ef*k /98& <nt/f"The &J{ ***y le orJtttd &*t* /he / tnH ***d msstf**/ "Me S/oefc M*. Olt -0/5- -flOd S'S'- iertf ^ iR&S -| &~st r*f**di. vf c/<x-- 0000335 The Viirl Chloride Threat and the Response of Government, Industry and Labor Frank Wiener We just got to noticing that there was just too ftw of us young mtn .. .loo many of us guys were getting out of tkis world too young. Raymond P. Gettelfinger, Jr. vinyl chloride worker horn: 1930 died: 1976 cause of death; angiosarcoma of the liver We use it every time we place a phonograph record on a turntable. And relax on it when we are sitting in our cars. And walk on it in our kitchens. We use it to paint our homes, to pipe our water, to hose our lawns, to package our food and drugs, and to insulate the wires and cables that conduct our electricity. It is contained in the shoes we wear, the toys with which our children play, the tables on which we eat, the counters on which we are served, our clothing, and even the dentures in our mouths. The plastic products manufactured from vinyl chloride are everywhere. - In only 30 years, vinyl chloride has grown from a fireproofing product in fighter planes to a $65 billion-a-year way of life. Through a process called polymerization, vinyl chloride, a sweet-smelling gas consisting of ethylene and chlorine, is converted by pressure and heat into a white, powdery resin called polyvinyl chloride (PVC), the second most widely used plastic in the United States. More than 5 billion pounds of polyvinyl chloride are produced annually in the United States. Vinyl chloride is also a carcinogen. It causes cancer in human beings. As early as 1949, Russian scientists discovered that workers who processed polyvinyl chloride into finished products such as shoes and insulation suffered bronchial and liver defects. The researchers believed, however, that these injuries resulted from a plastici/cr, polychlorinated hiphenyl IPCR), in the compound, and not from PVC. Of 75 polyvinylchloride workers examined in the Russian study, 18 had a liver condition that resembled hepatitis. .'.70 R&S 111777 ' Other European studies in the 1950s showed that polyvinyl chloride workers were subject to skin lesions and circulatory disorders. As a result of these findings, the Manufacturing Chemists Association (MCA), an industry group composed of such giant corporations as Dow, Allied, Monsanto, and Union Carbide, in 1954 recommended that exposure levels Vinyl ililnriitv h.is Wm linki-J tu umcis ltinn nlislruitimis, jnJ ivpriiilui.liiv tijiiljj-i- auntili<, work it-, mil livir (.lllliliv.. 1 tiis ivml.i'i Is ..cjfinj; ; pcr.uii.il munitnr tu nurture llit> tovi-t ul vinyl tliluritlc vj|iis Jt his woiksitr. HI (*<>i'Jrhft t*iviuu June 10, 1980 Dear Mr. Seawell: The Department of Labor has recently published a book entitled "Protecting People at Work" which is a reader in Occupational Safety and Health. In reading the book, X came to the case studies and discovered'there was a chapter on "The Vinyl Chloride Threat and the Response of Government, Industry and Labor" by a free-lance writer named Frank Wiener. I thought you would be most interested in reading it, if you haven't already, so I am enclosing a copy of the chapter. All is well with me. I'm still waiting to hear if I've been accepted to Graduate School. I've been spending a lot of time in Salisbury visiting my parents as they'll be moving to California this fall. I hope all is well with you. Hope to get over to have lunch with you one of these days. Take care Debbie R&S 111778 R&S 11 be limited to <00 parts of vinyl chloride per million parts of air (500 ppm). The MCA standard was voluntary and was often ignored. Workers directly involved in the polymerization process unknowingly continued to be exposed to levels as high as 1,500 ppm. The deadly gas can be smelled only when it reaches the dangerous concentration of 2,000 ppm. In 1961, Dow Chemical, one of the major producers of polyvinyl chloride, made a startling discovery. Laboratory animals exposed to 100 ppm of vinyl chloride had developed liver damage. The company immediately reduced worker exposure in its plants to 50 ppm. Unfortunately, the Dow findings, like the previous Russian and European studies, were generally ignored. Instead, the growing chemical industry continued to base its unofficial standards on the results of an earlier Yale University study which claimed that 500 ppm was a safe level. During the 1960s, B.F. Goodrich workers who manually cleaned vinyl chloride reactors developed a bone disease called acroosteolysis, which caused their fingertips to degenerate. After a 3-year study, scientists at the University of Michigan recommended a 50 ppm ceiling for vinyl chloride exposure, but, once again, the recommendation for lower levels was ignored. In place of a restriction, Goodrich developed the Hydraulic Reactor Cleaner, a device which eliminated most of the polyvinyl chloride residue that remained in the reactors once the conversion was accomplished. This advancement was supposed to reduce the number of times workers were required to enter the vessels foi cleaning and also reduced the time needed for each cleaning. At an international cancer symposium in Houston during July 1970, Dr. P. Viola of Milan, Italy, released his dramatic finding that high levels of vinyl chloride in the air caused test animals to develop malignant tumors. In 1972, the American Conference of Governmental Industrial Hygienists lowered its standard to 200 ppm, although existing federal recommendations remained at an unofficial, unenforced 500 ppm. In January l973, Dr. Cesare Maltoni of the Italian Institute of Oncology in Bologna informed a visiting American delegation from the Manufacturing Chemists Association that he had found malignant tumors, including angiosarcoma, in the livers of rats exposed to levels ot vinyl chloride as low as 250 ppm, half the unenforced U.S. standard in existence at the time. Maltoni's finding was the first scientific link between vinyl chloride and angiosarcoma, a rare form of liver cancer that is always fatal in human beings. The Manufacturing Chemists Association agreed with the European vinyl chloride producers, co-sponsors of Maltoni's research, that the discovery should be kept confidential in order "to minimize unwarranted speculation." Although a briefing on the Maltoni study was held on July 17, 1973, between the MCA and a delegation from the National Institute for Occupational Safety and Health (NIOSH), the fatal link between vinyl chloride and angiosarcoma was not revealed to the NIOSH officials. Later, in testimony before a U.S. Senate subcommittee. Dr. Marcus Key, NIOSH director at the time of the briefing, claimed that the chemical industry had been "less than candid" about the European studies. In fact, it was not until b months after the briefing that the federal government finally learned what the American and European chemical industries had known for a year. Once Maltoni made his morbid discovery, Goodrich privately began to respond in mid-1973 by quietly establishing a 50 ppm exposure ceiling and by initiating liver function tests for all employees involved in the manufacture of polyvinyl chloride. That spring, a Goodrich employee at the Louisville plant died of angiosarcoma. Linking this death to the recent Maltoni finding. Dr. John L. Creech, plant physician, discovered that 3 workers had died of angiosarcoma within the previous 2 years. He also noticed ijtat all three of the stricken employees had worked cleaning the interiors of the reactor vessels that convert vinyl chloride gas into plastic. For extended periods of time, the victims had inhaled high levels of vinyl chloride gas left in the vessels. The results ot the Goodrich liver function tests confirmed Dr. Creech's fear. They revealed that 23 of 271 workers at the Louisville plant had abnormal livers, including t> who had incurable angiosarcoma. Dr. Creech believed that the rare form of liver cancer was discovered first at the Louisville plant because it is one of the oldest polyvinyl chloride producers in the country, in operation since I9*t0, and therefore had exposed its vyorkers to vinyl rhtnndv longer than any other. The men whose tTcaths from angiosarcoma became known in 1074 had worked with vinyl chloride an average of year*., before they developed the disease. By n i means was the vinyl chloride problem confined to the Louisville plant or to a rare form of liver cancer. In Niagara Falls, New York, Local 6-277 of the Oil, Chemical, and Atomic Workers International Union requested Dr. Irving Selikoff, director of environmental medicine at Mt. Sinai School of Medicine, to send a research team to examine the workers of the Goodrich plant there for any possible ill effects. Of 348 workers whose lung function was studied, 58 percent showed significant obstruction of the airways. This obstruction was found in a large percentage of non-smokers as well as smokers. Even more frightening than the discovery of vinyl chloride as a carcinogen was the potential extent of the threat of this dangerous substance. In August 1974, Dr. Joseph Wagoner, director of field studies at NIOSH, announced that initial studies had found that death from liver cancer among workers exposed to large amounts of vinyl chloride occurred 12 times more frequently than would normally be expected. Some 6,500 workers in 51 American plants and even more in Europe are Involved in the production of vinyl chloride (1,500 workers in 14 plants) and polyvinyl chloride (5,000 in 39 plants). In addition, tens of thousands of American workers participate in the conversion of these raw materials into countless finished products, not to mention the hundreds of millions of consumers in all industrialized societies who are exposed to these products daily. Between 1961 and 1976, vinyl chloride was responsible for at least 45 Jealhs from angiosarcoma around the world. In 1974 alone, 15 cases of angiosarcoma had been discovered. Most of the victims worked for some time as reactor cleaners. However, others did not. Within weeks after the Louisville discovery. West German officials reported six cases of the disease among workers in a plant that manufactured finished polyvinyl chloride floor tiles. In Connecticut, health authorities documented the liver cancer deaths of two persons, one whq only had handled finished polyvinyl chloride products, the other an accountant at the plant! These discoveries indicated the catastrophic possibility that angiosarcoma threatened the hundreds of thousands of workers who converted PVC into thousands of industrial and consumer products. Even worse is the possible risk ol angiosarcoma to the general public from the thousands of widely used mnsurnei products made from polyvinyl chloride and from the 3o0 million pounds of vinyl chloride that is lost each year into the environment. For example, in January 1974, public alarm was aroused when a 62-year-old woman in Niagara Falls, New York, died from angiosarcoma. For nearly 30 years, she lived 4 blocks downwind from the Goodrich plant, which had manufactured polyvinyl chloride since 1946. If the danger of vinyl chloride causing a rare form of liver cancer is.jnpt disturbing enough, there is growing evidence that the substance might cause both genetic damage and birth defects among workers and their families. Referring to recent lab tests in the United States and Sweden, Dr. Selikoff warned that vinyl chloride "may affect the strands of material that carry the continuity of the human race from generation to generation." In 1975, Dr. Peter Infante of the Ohio Health Department underlined Selikoff's concern by reporting that birth defects were higher in three communities with PVC plants than the average for the state. Writing in the British journal, Tlir Lancet, Infante revealed that the rate of stillbirths and miscarriages increased two to three times among the wives of vinyl chloride workers when compa red to a control group whose husbands were not exposed to vinyl chloride. Other studies conducted by Ralph Nader's Health Research Group, NIOS11, and the Center for Disease Control confirmed a higher rate of miscarriages and stillbirths among wives of vinyl chloride workers, most likely because the chemical causes sperm cell damage in their husbands. In addition to angiosarcoma and sperm cell damage, other health risks linked to vinyl chloride have been found. Dr. Wagoner of NIOSH also reported that a study of 352 deaths of vinyl chloride workers around the country showed that exposure to the substance might increase the risk of cancer in the respiratory system, the digestive system, the blood-forming tissues, the brain, and the central nervous system. The plastic era--now about 35 pears old--is Just roiuiirg of age in terms of latent period for thr onset of disease among exposed persons . . . The workers are the `canaries.' I hep give us liiuls of what uv miglit find in tfir jvjiidutioii at large. Given the magnitude of tin* vinyl chloride threat to our society, how have the various seclois responded tosuih .: seiiou*> R&S 111780 R&S 111781 and complicated problem? Immediately responding to Or. Creech's discovery in Louisville, teams from NIOSH, Goodrich, and the Manufacturing Chemists Association began intensive studies of thousands of vinyl chloride workers in order to determine the nature, extent, and cause of illness among them. The Occupational Safety and Health Administration declared an occupational health emergency, giving vinyl chloride the highest priority among known hazardous substances. On April 5,1974, OSHA established an emergency temporary ceiling prohibiting exposure levels of vinyl chloride greater than 5C ppm. Only 2 weeks later, an independent lab. Industrial Bio-Test, announced that 2 mice exposed to vinyl chloride levels of 50 ppm had developed angiosarcoma of the liver! Without delay, OSHA proposed a permanent regulation on May 10 of "no detectable" worker exposure to vinyl chloride. The proposed regulation also would have required all workers in polymerization areas to wear self-contained breathing apparatus, and in some operations, completely impervious suits. Industry was quick to respond, almost unanimously, that OSHA's "no detectable level" standard could not be met. Taking the skepticism of industry seriously, OSHA changed its "no detectable level" standard to a ceiling of 1 ppm on a time-weighted average for 8 hours, with a 5 ppm ceiling for 15-minute intervals. In place of the self-contained respirators, OSHA prescribed more practical respirators and face masks. Workers were required to wear the apparatus only if levels exceeded 25 ppm at any given time. Beginning on April 1,1976, workers have been required to wear respirators for levels that exceed the 1 ppm regulation. At the conclusion of the permanent standard, OSIIA clearly defined its purpose and its priorities: Wr cannot wait until indisputable answers to these questions are available because lives of employees art at staler. Therefore, we have kad to exercise our best judgment on the basis of the best available evidence. These judgments have required a balancing process in ivliich the overriding consideration has been the protection of employees. In addition to OSHA, at least three other regulatory agencies have responded tn the harsh reality that vinyl chloride causes cancer in human beings. In 1^73, the food and Drug Administration banned the use of polyvinyl chloride liquor Vinyl chloride regulations have changed since this photograph was taken in early 1974. Under 0511A's emergency temporary standard then in ellerl, this s.ilHy Inspector checking for teaks near a reactor in a polyvinyl chloride plan! was not required to wear prolection, since vinyl chloride levels were apparently under 50 ppm.-The meter nn his portable analyier appears to be registering about JO ppm of vinyl chloride in the air. Under the current permanent standard, he would be required to wear an air-supplied respirator. bo1 ties when traces of vinyl chloride* were found in the liquor. On August 28,1975, the FDA proposed a ban on packaging food and drug items such as luncheon meats, salad dressing, vegetable oil, and mouthwash in rigid or semi-rigid polyvinyl chloride because the plastic has the potential for causing cancer. Acting; on a petition by Nader's l (ealth Research Group in April 1974, the FDA recalled a total of 49 products, mostly hair sprays, that contained vinyl chloride as an aerosol propellent. At approximately the same time, the ERA issued a rare emergency order to halt the sale of 28 pesticide sprays containing vinyl chloride. In December 1975, the trA proposed to cut by 90 percent the amount of cancel' t uusing vinyl chloride gas tn which l.t* million'people are exposed in 58 different factory areas. Russell Train, LI'A adnunistratoi, said the cost lo plants that produce vinyl chloride, ethylene dichtnride, ami poly \ myl chloride wi!' total $190 million, with $70 million needed each year to maintain control. The plants would also be required to reduce the amount of vinyl chloride in water discharged at an added estimated cost of $83 million. Even though the polyvinyl chloride industry delayed its response to the Maltoni findings for as long as a year, many large manufacturers did not hesitate in responding to Dr. Creech's discovery that vinyl chloride is a carcinogen. Goodrich's own corporate directive was to reduce the levels of vinyl chloride to "as low as possible as soon as possible." The company claimed to have launched in 1974 "the largest research, development, and engineering project in its history," involving $42 million over a 3-year period and more than 130 scientists and engineers. The development of reliable area monitoring systems and feasible respirators was especially problematic. When OSHA announced its permanent regulation of "no detectable" worker exposure to vinyl chloride in 1975, the plastics industry responded that such a limitation was medically unnecessary, technologically infeasible, and would lead to the U.l. (iuutirit fi lus iItvclin!il new I'lpiipim'iit nut prtm-ssi-s In i educe vinyl tliloiiJv i-iiilwium, miili js tills iu'w jmlyuiri i/.iliim reji tin .it its l uiii'.i iMv ptmt. ft.t. l| C . I.||MKV . v- - "ic i.'.' - ________ _______ - -- - - - _ loss of as many as 2.2 million jobs. Dow Chemical, however, had ?: , already managed to reduce levels of vinyl chloride to 10 ppm even before the 50 ppm limit was terminated. But the industry Jiv continued to press for relaxation of the OSHA regulations, *' - contending that plastics production in the United States would be . forced to shut down, not only throwing millions out of work but f -^ causing sales tosses as high as $65 to $90 billion. "jsVi-- The predictions of the plastics industry proved false, a.Instead of an industry-wide shutdown, there are at least four \ i ty'tiew vinyl chloride producers in existence since OSHA's "no I detectable level" standard went into effect. The cost of industry J compliance with the standard has been about $300 million, but tbe business continues to grow and grow. The price of plastic y\products to consumers did not rise nearly as much as industry predicted. In early 1975, Goodrich announced that vinyl chloride in the work atmosphere at all of its plants had been reduced to o ppm. It reported the following technological developments in c. combating vinyl chloride exposure levels: It could produce PVC resins containing less than 1 ppm of residual vinyl chloride. Newly developed technology allowed foi icuuumj,, recovering, and recycling nearly all vinyl chloride in the atmosphere. "Clean reactor" technology helped eliminate the need to enter reactors, except for maintenance. Respirators red from external air protected ivorkers upon entry to reactors. Leakages have been stemmed and new ventilation systems have been installed. New air-monitoring equipment has been purchased and measurements of the air are taken 24 hours a day. By December 1975, Goodrich announced that it had succeeded in controlling worker exposure to vinyl chloride, reporting that levels in all plants averaged from 1 to 3 ppm. Although the company expects no new cases of angiosarcoma to developsinq^the levels were successfully reduced, officials predict that new cases of the disease will occur as a result of eat her worker exposure to high levels of vinyl chloride. I he la*eut`period between a victim's first exposure to viml ihlniiJe and the development of i .mcer lao be as long as JO ) t u s. Abo in R&S 111782 R&S 111783 1975, John D. Ong, President of Goodrich, believed that regulations on vinyl chloride exposure for workers who process PVC into finished products would not be required because the levels of unconverted vinyl chloride in the plastic resin (less than 1 ppm) were so low that exposure of those workers would be practically nil. What has society gained from the tragic vinyl chloride affair? At least one expert. Dr. Selikoff, sees some benefit from the experience: It was a success for science in having defined the problem; success for labor lit the rapid mobilization of concern; success for government in urgently collecting data, evaluating it, and translating it into necessary regulations; and success for industry in preparing the necessary engineering controls to minimize or eliminate the hazard. Despite these successes, however, many unresolved questions about vinyl chloride remain. Can workers be completely confident that they are now safe from such a potentially dangerous substance? Even if vinyl chloride is undetectable in finished products today, how can we be certain that levels will remain as tow after the passing of time, under certain atmospheric or climatic conditions, and during certain chemical combinations or changes? Research has already found that the deadly gas not only causes angiosarcoma and sperm-cell damage but also increases the risk of cancer in other vital organs and systems. Why should anyone, least of all vinyl chloride workers, rest comfortably knowing that the finished products made from such a dangerous substance constantly surround us? The threat of vinyl chloride cannot be forgotten or underestimated. Science, industry, government, labor, the media, and organizations like the Health Research Group have fulfilled certain responsibilities by contributing their energy and resources to deal with a very serious problem. They must continue in their efforts. Above all, the American public, expecially those who are exposed to vinyl chloride in the most direct and prolonged way, have a right to be informed about all future developments that relate to this dangerous substance. I rani IViriirr is n tree- tuner writer. I Black Lungt The Struggle to Help its Victims Lorin Kerr, M.D. At work, coal miners are covered with dust. It's in their hair, their clothes, and their skin. It gets between their teeth and they swallow it. They suck so much of it into their lungs that, until they die, they never stop spitting up coal dust. Some cough so hard, they wonder if they have any lungs left. Gradually the miners notice they are getting short of breath when they walk up hills. On the job they must stop work to catch their breath. Then, just walking across the room at home is an effort. For all too many of them, severe shortness of breath leads to total incapacity for work, and eventually premature death. Coal mine dust is a killer, though death comes slowly. For centuries, coal was dug out of surface outcroppings and shallow mines. In Britain, this began about 1234. There was little dust and so there were no dusty lungs. This began to change in the eighteenth century, however, with the advent of ... Black lung victimizes more tlun one out of three coat miners. I