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Job sflPEiy ^HEALTH U S. DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION JANUARY 1975 VOL 3 NO. 1 Articles 4 'The Best Available Evidence" An overview of OSHA's vinyl chloride standard--where it came from and what will happen when it goes into effect. 13 Dermatitis: Causes and Cures Probably the most common occupational diseases, skin disorders can hurt, cost money, and even jeopardize safety. But they also can be prevented. 18 No Fifth String, Please Some independent workers, like shingle sawyers, are reluctant to accept changes--until one of their own comes up with a better idea. 23 Insuring Safety Labor-managenfeht cooperation was the spark that led to improved workers' compensation and fewer accidents in New York City's electrical industry. 27 Vinyl Chloride~The Canary in the Coal Mine Two leading scientists discuss the implications of the vinyl chloride health hazard. `* Departments 31 Historical Hazards 32 Review Commission 33 Spotlight 34 News from NIOSH 36 Publications 23 25153002 aqi `SJ33JJOM SuiATJ JQ SUOpBUIUIBXS pUB SpJO -03J 1B3ID3IU u3npSm^3U3JB3S 3AISU3JX3 J3JJB gujsnpui sb `souBjsqns 3|no3|ouj apuoiqo |Auia am--Jaiipt , papiAuoo A|/wauv rSuiqjBsaq sjdopd sqj J3UIUJ3Ap8 OJ !pUBt XjJ -4 rsnpt &3UI33S'^UOJ^' TM `}U3Ui33uni5Qq* gb ^ j ; $*2'* ' IBOipSUI P]0 J0| 1PN.L qnd ssuren ~jf p3ip~ oqM sXr ay ^ufqjXuBif aqoqo jo ussjS tib/j mj j.ussop jig --1B3J i)S aqj sqjBdjq : noX go jno ijaq 31* JH t dsBj3 oj 3]d |3puojqo jXb ^sflBS px Li jb Im/OZ sXba `jnq'qi jnoqB Smc JUBid s.JBaVt jqSispufE Bos op oj qSnou3jj( J.U3J3M 3AI SS3n3TJ V33UB3 JO p3lp OS-pu| jBqj JBsq jq3nq 3aa jbj sqjnoui puB `Xb o8 jsnf p.Xsqj, *sn jo jqojj ui jq3u UBd?| uisqj, 33S j.upip 3M 4Bqj `qSnoqj `jsquisf oj 3Ab|i ndX 8oiXp;^?M sfdosd jno jo Xb Q<^^ftx^ig9^piB>Bq -swaX msj V;, *s -"^a 'oljBX^Soidsns jno pq PACl *.... sjsqjOAVap K>iif^jXuiA'i BUIOOJBSOlSuB JSj| 3qjr|q.Xj3A03sj{y| ^qoouuB sji qjrn XiBnonj IS^IBI^PI^ fl^UIA SppAppOM ?qj jjdl :#pf 'a siqBJnoui si ji jij * B3 JBQJ J33UB3 J3AIP JO '; po ip? sXojddia xj*5*3*- J3J[JOAi^l8s J<* fpj^p p pIS3J*djJoipBy iov^%n% &iq-3mg " jblT btr . ;js * t* uaiiM^ jj .44 am| *mr&J mm- M - ~X; . '' -S'%- if: S* 44MM ^ageilli 25153003 25153002 number of cases stands at 16 in this country are far more clear-cut. There are three basic and 26 world-wide--extraordinarily high fig steps in the production of finished vinyl ures when one considers that just over 100 products. At the first stage vc, or the "mon cases of angiosarcoma of the liver had pre omer," is produced through a closed proc viously been reported in medical literature. ess, usually involving a reaction between All the quoted figures may be too low, in ethylene and chlorine, vc monomer is then fact, since angiosarcoma is so rare that it shipped as a liquified compressed gas to the may often go undiagnosed. Four of the first plants that manufacture pvc resin. There, 10 U.S. cases among vinyl chloride workers batches of vc are "polymerized" by mixing were discovered only upon re-examining with catalysts in giant vats or reactors. After slides of pathologic tissue taken during au drying, the resulting pvc resins are "com topsies. Beyond sheer numbers, though, the pounded"--a process in which stabilizers, deaths have raised disturbing questions lubricants, and plasticizers are added. Be about a whole modem life style that depends fore being bagged for shipment to fabricat so heavily on products derived from syn ing plants, the resins may be converted to thetic chemicals. pvc pellets. The final step--the fabrication Because of its versatility and relative end of the industry--covers a huge range of cheapness, polyvinyl chloride, or pvc, is processes in which the pvc is turned into used in about 55 percent of plastic products. finished products. In the United States, there Chances are you ride to work on a vinyl are 15 monomer plants employing 940 work seat, walk across vinyl-tiled floors on shoe ers, 36 pvc plants with 5,600 workers, and soles of pvc, eat sandwiches wrapped in about 7,500 fabrication plants with approxi pvc film from a vinyl tablecloth, and relax mately 350,000 employees. to the sounds of pvc records. The week-old At each stage of the process, there are infant in his mother's arms is likely to suck certain trouble spots where vc is likely to on a vinyl pacifier. In its early days, during escape into the air. Both monomer and po World War II, vinyl chloride gas (vc) was lymerization plants face the problem of con even used for a brief time as an anesthetic trolling random leaks that occur from pump during surgery. seals, compressors, valves, gaskets, and stor Are these finished PVC produots danger age tanks within the vast closed systems. ous? Aerosol propellants using vc gas -- Both must also deal with reducing emissions mainly hair sprays and pesticides -- have that occur in quality control sampling. Dur been banned by various government agen ing loading or unloading of the vc monomer cies, but so far no one has discovered harm for shipment between plants, tank car load ful effects from unreacted vc gas leaching ers may be exposed to as much as 200 parts out of finished pvc products. Researchers per million (ppm) of vc in air. from the Food and Drug Administration, When the commercial process for manu the Environmental Protection Agency, the facturing pvc plastics was first introduced in National Cancer Institute, and the Con the late 1930's, the prime worry was keep sumer Product Safety Commission are fol ing concentrations of the volatile vc gas low lowing the problem closely, however, and enough to avoid explosions and fires. As a the National Institute for Occupational result, production facilities are usually Safety and Health (niosh) is conducting an spread out over plant sites of several acres, experiment in which pvc pellets are placed vc in the air, then, is not confined to a small in closed chambers and monitored for escap area, but low levels often can be found over ing vc. In an interview with cbs News, the entire plant. Most monomer plants, Ralph Harding, president of the Society of which are usually open-air facilities, have the Plastics Industry, remarked about these lower concentrations than polymerization products: "Nothing in these days is totally plants. certain without a great deal of detailed study The highest exposures in the polymeriza :a and there hasn't been time for that, but I tion plants are experienced by the workers l,.) know in our case, we're going right ahead who climb down into the reactors to chip and using all these products with no con out pvc residue, in some plants with a ham cern, no fear, in the case of our own fam mer and chisel, vc concentrations as high as ily." 1,600 ppm have been reported in the reac After a year now of intensive study by tors in the past, and exposure levels can individual companies, osha and niosh, and still reach 500 ppm for reactor cleaners. (A union-financed researchers, the problems of Fourteen of the 16 U.S. deaths have occur controlling vc exposures in the workplace red among men who at one time or another 5 U These two old-style processes, which allowed VC tr> escape into the air, are 1 phased out in VC n._. omer plants. Below, VC mist is vented to the air as a way of gauging the amount of VC in the tank car. Below right a worker draws a sample from the closed system for lab analysis. cleaned reactors. This figure may be some what misleading, however, since, at the Louisville plant at least, this job is the usual starting place for new hires. Fabricating plants are most concerned about the small amounts of vc left in pvc resins. During shipment or storage it can leach out through the bags or into the box if packaged in bulk. The fabricating oper ations with the most potential for exposure involve heating the resin, as in extruding pvc around an electrical wire, a case where any unreacted vc may be driven off into the air. In the year since the B. F. Goodrich rev elation, much more evidence linking vc with angiosarcoma of the liver has come to light. In 1958 and 1959 Dow research scientists reported that, when inhaled, vc concentra tions as low as 100 ppm could cause liver problems in rats and rabbits. Based on these results, Dow set a limit of 50 ppm as a timeweighted average (twa) for its own plants. In 1962, however, the American Conference of Governmental Industrial Hygienists, rely ing on different research results, set a twa of 500 ppm, which aimed primarily at pre venting nauseous effects in workers. When osha came into existence in 1971, this 500 ppm limit was adopted as the osha stan dard. It remained in effect until April 5, 1974, when osha's emergency temporary standard cut the limit to 50 ppm. Meanwhile, in 1970 Dr. P. L. Viola, a physician for the European chemical firm Solvay, undertook a series of animal experi ments to investigate acroosteolysis--a condi tion involving softened finger tip bones that had become common among pvc workers, especially reactor cleaners. Quite by chance. Dr. Viola discovered that rats inhaling ex tremely high doses of vc -- 30,000 ppm -- developed cancerous tumors. Because of im pure vc in Viola's tests. Dr. Cesare Maltoni, acting at the request of European chemical companies, began exposing test animals to lower concentrations. Preliminary reports of Maltoni's work showed that levels as low as 250 ppm were inducing various tumors, in cluding angiosarcomas, in rats. When this news filtered back to the American plastics industry, the Manufacturing Chemists Asso ciation in early 1973 contracted for animal studies with Industrial Bio-Test Labora tories and for an epidemiologic study of vc workers with Tabershaw-Cooper Asso ciates. The first results of the Bio-Test ex periments came through in April 1974 after Dr. John Creech, Goodrich's plant physician in Louisville, had independently discovered the first angiosarcoma deaths among work ers. The results showed that some mice ex posed to 50 ppm, as well as rats and ham sters at higher levels, developed angiosar comas of the liver. In June of last year Maltoni confirmed the Bio-Test results with evidence that vc induced angiosarcomas in both rats and mice at 50 ppm and in ham sters at higher concentrations. The animal evidence by itself raises prob lems of interpretation in setting safe ex posure levels for humans. Maltoni clearly identified a dose-response effect. That is, the more vc his test animals breathed the more likely they were to get cancer. But no results from ongoing experiments at levels below 50 ppm are currently available. However, Dr. Marvin Schneiderman of the National Cancer Institute has predicted that, based on Maltoni's data, tumors will occur below 50 ppm if enough animals are exposed long enough. "r Js. Secondly, many in the plastics industry question the whole concept of extrapolating effects on animals to similar effects in man. While it is true that different species of test animals frequently respond to a chemical in different ways, in 1970 the Surgeon Gen eral's Ad Hoc Committee on the Evaluation of Low Levels of Environmental Chemical Carcinogens stated that "the finding of can cer in two or more animal species may be extrapolated to indicate a carcinogenic haz ard to humans." This principle recently withstood a challenge in court when the U.S. Court of Appeals for the Third Circuit sub stantially upheld osha's standard on ethyleneimine -- a carcinogen that had been proved to cause cancer in rats and mice. "We'll probably never have a more clearcut set of animal data than with vinyl chlo ride," says Dr. Donald V. Lassiter, special assistant for occupational health in osha. "It is very unusual to find the same tumor in the same organ--in this case, angiosarcoma of the liver--in both animals and humans exposed to the same chemical." The discoveries of excess cancer in popu lations of vc workers certainly add weight to the animal evidence. The major epide miologic studies and their results so far in clude: Tabershaw-Cooper Associates -- 8,384 vc and pvc workers were studied. Research ers Dr. Irving Tabershaw and Dr. William Gaffey found that, in addition to angiosar coma of the liver, there were more cancer ous tumors than expected in other parts of the body, including the respiratory system and the brain. They also found that the total number of people dying in the study popula tion was only 75 percent of what would be expected for the general population. The re sults are limited by the number of workers in the study who have had only short term exposures to vc. Harvard School of Public Health--Dr. John Peters and Dr. Richard Monson studied the deaths of 161 workers at two B. F. Goodrich plants in Kentucky. They found that deaths from lung cancer and suicide occurred almost twice as often as expected, from brain cancer four times as often, and from angiosarcoma of the liver 10 times as often. The death rate in the study increased greatly after 1965. Mt. Sinai School of Medicine -- Under the direction of Dr. Irving Selikoff, medical examinations were given to currently em ployed workers at Goodyear's Niagara Falls pvc plant, and a mortality study of 255 em- 3 .** ployees and former "employees with long term exposures (over 10 years) was under taken. Among the workers examined, the re searchers found significant numbers of lung and liver abnormalities. It was also discov ered that three of the group of 255,workers had died of angiosarcoma of the liver. The rate of death from cancers of all types was considerably higher than expected in this group, and the overall mortality rate was slightly higher than expected. niosh--Along with the Center for Dis ease Control in Atlanta, niosh is conducting a national search for all angiosarcoma deaths since 1965 and an epidemiologic survey of 11 polymerization and fabricating plants. Though the survey is not completed yet, study director Dr. Joseph Wagoner says that so far excess deaths from cancers of the respiratory system, blood-forming tis sues, and brain--as well as the liver--have been uncovered. The total number of deaths in these 11 plants is also more than could be expected. University of Louisville -- In a program just getting underway, B. F. Goodrich has contracted with the university's medical VC workers at Dow's Midland, Michigan plant are given a series of medical tests by a team from Mt Sinai School of Medicine in New York. Because angiosarcoma of the liver is so rare, good medical surveillance is crucial to detect new cases. Aerial view of a Texas plant where VC monomer is manufactured. The highest exposures in this type of plant usually occur during tank car loading. school to establish a better examination pro cedure for early detection of angiosarcoma, start a registry of angiosarcomas of the liver in the Louisville plant and eventually for the entire industry, and begin a basic research program into vc effects. These studies basically agree that: Deaths from angiosarcoma of the liver occur far more frequently among vc work ers than would be expected. There also appears to be an excess of cancers in other parts of the body. The incidence of cancer rises sharply after 15 years from onset of exposure. To set a safe level of exposure for vc, based on these facts, is no simple task. The chief problem is that no one has an accurate record of how much vc the dead workers were exposed to. It is generally agreed that vc levels in the 1940's were extremely high --perhaps reaching several thousand ppm in operations such as reactor cleaning--and that exposure levels have been gradually lowered since then. Since companies did not monitor extensively for vc until recently, ex posure estimates are based largely on indi vidual workers' memories of smelling vc in the air. (The odor threshold apparently varies between 400 and 2,000 ppm for dif ferent people.) The casual attitude toward vc levels in those days can be seen in one veteran worker's comment: "When there was enough of the stuff so that you could smell it, we just thought it was a cheap drunk." For reasons mentioned earlier, Dow did monitor fairly closely and did strive to keep exposure levels low long before the rest of the industry. At the hearings on osha's pro posed standard, Dow was able to present evidence that 335 employees exposed for seven years at levels under 200 ppm had not developed angiosarcoma of the liver. Unfortunately, however, this group excluded many workers with the longest exposures (over 20 years). Another puzzling fact is that, so far, an giosarcoma of the liver has been found in only three of the eight U.S. polymerization plants that have been operating for more than 20 years. Industry spokesmen have im plied that there may have been high ex posures or some strange chemical mix pe culiar to the three plants. However, since comprehensive studies with good followup rates for all polymerization plants haven't been completed, it is not possible to con clude that angiosarcoma won't show up in any of the other plants. Industry-wide, about" three-quarters of all the employees who have gone more than 20 years since onset of ex- posure (the group at greatest risk) haven't been traced yet. The missing piece at the very center of the puzzle is that cancer researchers are not entirely sure how the basic cancer-causing mechanism works. "Many people who work in ddncer research would say that any level of carcinogenic exposure, even the smallest amount, is not safe," says Dr. William Lloydv head of niosh's Office of Health Sur veillance and Biometrics. "We now believe that cancer may not result from the cumu lative build-up of a substance over a period of time but that it may be activated by a single instance of exposure." The Surgeon General's Ad Hoc Committee on Carcino gens also concluded that a "safe" exposure level for any carcinogen cannot be deter mined. In proposing a permanent standard for vc, osha relied, then, on a combination of animal and human data, considerations of economic and technological feasibility, and niosh's recommendation that any employee exposed to vc should wear a respirator. osha's proposed vc standard, issued on May 10, 1974, set a limit of "no detectable level," which was defined in measurement terms as 1 ppm. At hearings on the proposed standard, representatives for plastics companies point ed out that it was simply impossible to re duce vc levels low enough to meet the stan 8 ma dard, painting a grim picture of the economic disruptions that would occur if the standard went into effect. Speaking for many in the industry, B. F. Goodrich said that it would be forced to close its plants. According to a study by a consulting firm hired by the Society of the Plastics Industry (spi), 2.2 million workers could be thrown out of work and as much as $90 billion in produc tion lost each year in plastics and related industries if all vc production were to stop. A study by osha's own consulting firm, which relied on data from the plastics com panies, confirmed that at present, the tech nology to eliminate all leaks in monomer and polymerization plants does not exist. The spi recommended a phased reduction schedule of vc levels, starting with a 25 ppm twa and 40 ppm ceiling to go into effect in 1974 and culminating in a twa of 10 ppm and a ceiling of 25 ppm in two years. At the opposite extreme stood Peter Bommarito, president of the United Rubber Workers who spoke for the entire afl-cio when he said, "This country survived for nearly 200 years without pvc, and we can survive in the future without it. If PVC can not be made and used safely, then the pro posed standard must be replaced by an orderly procedure to phase out vinyl chlor ide production and find substitutes for its products. . . ." The lines were drawn. Faced with a de cision that, in Bommarito's words "would test the wisdom of a saint," osha gave prime consideration to workers' health but, at the same time, promulgated a standard it be lieves will allow the plastics industry to continue to operate. In essence, osha's permanent standard on vinyl chloride, published in the Federal Reg ister of October 4, 1974, requires that em ployers limit vc exposures to 1 ppm as a twa and 5 ppm as a ceiling. If feasible en gineering controls and work practices will not reduce levels to 1 ppm, they must be used to reduce exposures to the "lowest practicable level" and employers must make respirators available to employees. For the first year--until January 1, 1976--each worker may decide whether he wants to wear a respirator as long as the levels he faces are not over 25 ppm. There are no deadlines for reaching the 1 ppm level through engineering controls since the tech nology is so uncertain, but employers must draw up plans for reducing levels and make them available to osha. .SL4 One key provision of the standard outlines what parts of the many-sided pvc industry are covered. The standard applies to the "manufacture, reaction, packaging, storage, handling, or use of vc and pvc" but not to the handling or use of finished pvc products, pvc is not considered a "finished product" until it passes all stage's of production where mass melting occurs. The standard, for in stance, covers such fabricating operations as injection molding, extrusion, banbury mix ing, and calendering but does not include thermoforming or blister packaging. During the hearings the spi recommended that fabrication plants be exempted from the standard because vc exposures have been very low in these plants. However, some exposures in fabrication facilities do exceed 1 ppm. In a survey of seven fabricating plants, niosh found an average twa of about 2 ppm. In addition, there have been reports in Connecticut of two angiosarcoma deaths in fabricating plants. One case involved a worker who ran a wire coating machine that extruded pvc, and the other involved an ac countant who had occasionally entered a building where pvc was made into calender ed film. Neither tumor entirely fits the pat tern of angiosarcomas in other vc workers, but these deaths raise a very provocative question. Because fabrication workers are the ones most likely to have had long-term, low-level exposures to vc in the past, evi- About 350,000workers use PVC resins to fabricate finished plastic products. Most experts believe fabricating plants should have little difficulty in meeting OSHA's standard of one part per million VC in the air. 9 dence from these plants is crucial in estabfishing a "safe" or minimal risk level of exposure. To meet the problem of covering the great variety of fabricating operations, then, the concept of an "action level" has been written into the standard. If a fabricating plant finds that vc exposure levels are below 0.5 ppm on initial monitoring, then that plant is effectively exempted from most of the rest of the standard. These employers need not monitor again unless they have some reason to suspect that exposures have gone up or changes have been made in the production process. (Plants where exposures are above 1 ppm must monitor at least monthly.) Most fabricators believe their plants should have little difficulty getting down below the action level with minor improvements in ventilation. Under the requirements for monitoring methods, osha has left the employer considerable leeway by writing a "performance" standard which requires only that the method used be accurate within certain limits. The reasoning behind this is that vc monitoring methods are undergoing rapid technological improvement. At the Society of Plastics Engineers' recent conference on vc, 27 different manufacturers of vc moni tors displayed their wares, including such equipment as infrared analyzers, continuous monitors using a paper tape, and portable gas chromatographs. The method chosen may make use of either personnel sampling --measurements in each worker's breathing zone--or area sampling. Perhaps the simplest and cheapest method is the carbon tube used by niosh and by osha inspectors. As an air sample is drawn through the tube, the carbon absorbs the vc. The chief disadvantages of this technique are that the carbon must later be analyzed in a lab for vc content (niosh will do this) and that the sampling time of two hours makes short peaks of exposure hard to de tect. A detailed account of how to use this method can be obtained by writing to niosh. Office of Technical Publications, 1014 Broadway, Cincinnati, Ohio 45202. Ask for a copy of p&cam No. 178--"Vinyl Chloride in Air: Physical and Chemical Analysis Branch Analytical Method." Other provisions of the standard include: > Regulated areas--In parts of a plant where vc levels exceed 1 ppm, a regulated area with access limited to "authorized per sons" must be established and daily rosters of the people who enter it maintained. Since the standard aims at protecting people, only those areas where workers are actually present are crivered. Training--Employees must be informed of the cancer risk associated with vc, instructed in%the proper uses of respirators, and made aware of work practices that could release dangerous amounts of vc into the air. Medical surveillance--Annual medical exams, including blood tests, must be given free of charge to all employees exposed to levels above 1 ppm, regardless of whether or not they wear respirators. For employees with over 10 years exposure, the exams must be given every six months. At the request of the examining physician, alternative medical tests may be substituted for osha's recommended procedures. Signs and labelling--Warning signs in regulated areas and labels on pvc containers and in a It com OSHy lievt tion ham Hari dard prac nolo and pass inat< safe er's on t requ Ri are i "We the s Shel< and Unio CIO, push writt ing i holdi but t requi visioi moni level delet food bor : done mem sendi tin e worn At engaj over and t dard likely must include the words "cancer-suspect 'ft! i.Wbe h agent." * ,1 Cour Recordkeeping--Monitoring and medi- "Cn " *" schec cal records must be maintained for at least , .01 Dece 30 years, and these results must be made - *0 `""CJ upho available to employees and their representa- CT ^ or p< tives. This is the first time section 8(c)(3) '-Z- 01 of the Act, the "employee rights" provision, v-" *-'0 sider: *'3 case has actually been written into a standard, dard. ao o c stsz and similar provisions are likely to appear in all future health standards. It goes without saying that the plastics companies are not happy with the standard osha finally promulgated, "osha may be lieve that it has adopted a compromise posi tion between organized labor on the one hand and industry on the other," says Ralph Harding of the spi, "but the result is a stan dard that does not take into account in a practical way the known medical and technological facts. As we read the osha Act and the legislative: intent expressed prior to passage, the law was never intended to elim inate the worker's job in order to make it safe nor was it intended to make the work er's eight-hour day the equivalent of a shift on the rack [a reference to the respirator requirement]." Representatives of the workers involved are much more hopeful about the standard. "We didn't get everything we wanted, and the standard has some serious failings," says Sheldon Samuels, director of health, safety, and environmental affairs for the Industrial Union Department (iud) within the aflcio, "but many of the goals the rur> has been pushing for since the beginning of osha were written into this standard--things like keep ing medical records for a long term and holding an industry not to its worst plants but to its best plants in setting up feasibility requirements. The voluntary respirator pro vision bothers us, we feel that continuous monitoring should be required for the ceiling level, and we think osha made a mistake in deleting the proposed requirement to keep food facilities separate. Overall, though, la bor feels that the Office of Standards has done its best job to date." To individual members of the unions involved, the iud is sending out 25,000 copies of a special bulle tin explaining why respirators should be wom. At press time, the plastics companies were engaged in complicated legal maneuvering over the osha standard. Several companies and the spi had filed suits against the stan dard in appeals courts. All the cases are likely to be consolidated into a single suit to be heard before the U.S. Second Circuit Court of Appeals in New York. The court scheduled a hearing for the third week of December 1974. In the end the court may uphold the standard, or it may remand all or part of the standard to osha for recon sideration. The afl-cio has entered into the case as a party on the side of the osha stan dard. In a separate action the spi has peti tioned osha to stay the standard until enough respirators are available to imple ment it or until the court of appeals makes its ruling. If osha denies the petition, the spi may go to court seeking a temporary stay of the standard. If the standard is upheld, will companies be forced out of business? At this time, few within the plastics industry are willing to make predictions about that subject. A typi cal view is that' of Richard Fleming, vicepresident of Air Products and Chemicals (one of the companies challenging the stan dard in court): "There are tremendous pres sures on the industry to cause it to try to operate rather than to shut down immedi ately--the job security of perhaps hundreds of thousands of employees and the billions of dollars invested in plants. For these rea sons, most vc-pvc operations may be ex pected to make every effort to comply. I cannot project what will come of these ef forts or how long they will be continued. This will surely vary with the individual firm. It is abundantly clear that, if any pro ducer can comply, the costs for vc and pvc under this regulation will go up dramati cally and production volumes will decline sharply." Below, a cut-off pipe returns VC to the closed manufacturing system when a pump must be repaired. Below left, a safety inspector takes a "grab-bag" air sample to be analyzed for VC. Meanwhile, most companies seem to be ing. Magnetic loading gauges are also being going ahead with plans to reduce vc levels put into service so that the loader doesn't and order respirators. In its third quarter have to vent vc into the air to check the report for 1974, B.F. Goodrich announced level in the car. Lab workers removing vc tha 2 million would be spent in the next samples from the system use a closed loop three or four years to cut exposures in its sampling method that prevents any vc from six monomer or polymerization plants, mod escaping, and all unused samples are re ernize facilities, and increase production. turned to the system. When any part of the B.F. Goodrich is also continuing construc system needs to be opened up for mainte tion of a new Louisville pvc plant with vast nance work, it is first purged with inert ly improved technology to be completed in gases. 1975. Almost everyone in the industry agrees "There is no big technological break that the ultimate answer to getting VC levels through just around the corner that is going in fabrication plants even lower is to reduce to cut exposures overnight," says Dr. Paul the amount of unreacted vc monomer in pvc Lobo, director of the organics and polymers resins. All pvc producers are making efforts division for Tenneco. "Right now we have along these lines, though the tricky chemical 1 ppm of vc in the plant offices, and we're balancing process involved means that pro not even sure where it's coming from. Most duction has dropped slightly and the pvc of the improvements are going to be step- produced is not as high-quality. Still, the by-step, trial-and-error things that take outlook in this area is encouraging. Tenneco, time." as one example, is aiming at 50 ppm of vc Considerable progress has been made in pvc resins, and the company's plant in since the emergency temporary standard Burlington, New Jersey, has reduced these went into effect on April 5 last year. At the levels to 20 ppm and lower. Before 1974, hearings last summer, John Nelson, a Good the amount of unreacted vc usually ranged rich vice-president, testified that vc levels in between 300 and 500 ppm in the resins. the Louisville plant had been cut from the In the end, the tragic paradox of setting 35-40 ppm range to 12-14 ppm at that time. a standard to protect vc workers is this: At another company's pvc facility, an in Proof that low-level vc exposure is danger door plant with small reactors, levels had ous--at least the kind of proof that industry beei t to as low as 11 ppm last summer is demanding--will come only in the form and, uncording to union sources, are now in of more dead workers in the future. Obvi the 3-5 ppm range. ously, though, since vc workers pannot be Much of the activity in polymerization treated like experimental animals, we must plants focuses on ways of reducing expo rely on the "best available evidence" at pres sures when reactors are cleaned. Part of the ent to minimize risks for these workers. problem is that the smaller the reactor, the "I would feel safe at 25 ppm," says Rich more often it must be cleaned and the more ard Fleming of Air Products, "and I potential for exposure. In some older plants wouldn't be saying that if I felt that we reactors can hold 1,100 gallons, while in would be killing a lot of people. I have no newer plants reactors with 20,000 to 35,000 incontrovertible evidence, but you have to gallon capacities have been built. B.F. Good remember that nothing in life is totally with rich uses a high-pressure water spray system out risk. You can't eliminate risk and still built into the reactors, making it necessary live, so you have to balance the risk factor to open them up less often. Tenneco has against practicalities." licensed a new pvc process, which, in the "I have to rely on other people to let me ory, should allow no film deposits on reactor know if my health is in danger," says San walls. Consequently, it is hoped reactors will ford Beck, president of the Oil. Chemical, not need to be opened on a routine basis and Atomic Workers' local at Air Products' in the Tenneco plant now being built in Calvert City, Kentucky, plant. "I know Pasadena, Texas. nothing about the medical terms. I don't At its three monomer plants in Texas, want to see the plants shut down and people Dow has instituted a series of procedures out of work, but I don't want to see them that were keeping exposure levels below 10 dying at an early age either. If man can go ppm at the time of the hearings last summer. to the moon, surely we can control vinyl When loading tank cars, for instance, the chloride." hose is completely emptied into the car by Mr. Clack is assistant editor of Job Safety & purgr it with nitrogen before disconnect- Health. 2 fO cn on CJ oo QD r EM1W W!)) Jl\W U /V/1/ P me c di; di hurt, i jeopa Bi can b Ihe jl Vinv Chloride Canary in the Coal Mine Two leading scientists discuss the implications of the vinyl chloride health hazard. Shortly after osha's permanent standard on vinyl chloride came out, Job Safety and Health talked with two researchers deeply involved in the investigation of angiosarcoma among these workers. Dr. Irving Selikoff, director of the Environmental Sciences Laboratory at the Mt. Sinai School of Medicine, first became well known for his research into diseases related to asbestos. He is also the editor of the Journal of Environmental Research, president of the Society for Occupational and Environmental Health, and a past president of the New York Acad emy of Sciences. Dr. Joseph Wagoner, director of the Division of Field Studies and Ginical Investiga tions of the National Institute for Occupational Safety and Health (niosh), is heading up niosh's epidemiologic study of workers in the vinyl chloride industry. Q. Both you and niosh, Dr. Selikoff, have recom~ mended a "no exposure" level for vinyl chloride. Are the limits set in osha's standard--1 part per million (ppm) as a time-weighted average and 5 ppm as a ceiling--adequate to protect workers? Dr. Selikoff: I interpret the 1 ppm limit as being a no exposure level. It is unlikely that any company would instruct its engineers to plan a system with a small leak. They would design production processes with a zero level in mind, recognizing--as I think osha has recognized--that in human affairs some slight mistakes will occur. Dr. Wagoner: There is no compromise in the stan dard as far as the 1 ppm average or 5 ppm ceiling goes. I think these are entirely consistent with what niosh has recommended. There is really no accept able level of exposure since science is unable to de fine what a "safe" level for a carcinogen is. But we recognize that we have to take into account the sensi tivity of our measuring instruments. From that point of view, then, I have no problems with the 1 ppm level. Q. Do you see any problems developing from the part of the standard that says vinyl chloride levels must be reduced to the "lowest practicable levels" through engineering controls and that respirators will be made available if these levels are above 1 ppm? Dr. Selikoff: I think implementing the standard will have to be worked out on a plant-by-plant basis. In the large polymerization facilities the design for reaching 1 ppm levels is already available as func tioning units. In at least two polymerization plants, I have seen on-line equipment that was giving 1 or 2 ppm some months ago. I have great confidence in the engineering skills of our petrochemical industry, and I believe that the 1 ppm requirement will be met relatively soon. It is true that there may be some processes in which attaining this level will be difficult. But I am sure there will be no compromise on the part of osha with the essential principle--that no workers be exposed to cancer-producing chemicals. Dr. Wagoner: I think there are certain problems with the .standard. I sat on the Advisory Committee for Asbestos when one of the world's leading experts on respirators described them as pure instruments of torture. We have to recognize that respirators are no substitute for good engineering control. A respirator can be totally effective, but if it's not used, it is worthless. And I think the standard's reliance on voluntary usage of respirators for that first year opens the way to major problems. [Between January 1, 1975, and January 1, 1976, wearing a respirator is at the individual worker's discretion if vinyl chloride levels are below 25 ppm.] Many plants are not organized, and this provision seems to leave enforcement activity up to the worker. If we accept the concept that there is no known safe level for a carcinogen, then it seems rather inconsistent to say that we will make using a respirator voluntary. During our own investigations on vinyl chloride, we refused to put any niosh investigators into any plant until we had adequate respirators for them to wear. On this basis we feel strongly that it should be mandatory for the worker to have the benefits of those respirators, too. 27 25153009 liltQ. Why are the nu1 liJ paying so much attention to vinyl chloride wherA0J/heer toxic substances have had equ disastrous effects on larger groups of wor^s? Dr. Selikoff: There are a number of reasons for this. Through bitter experience in these past 10 years, we have all become thoroughly aware of the long incu bation periods associated with occupational cancers. This has been true of cancers caused by asbestos, arsenic, benzidine, beta-Naphthylamine, and so on. The petrochemical industry, which grew enormously during and following World War II, has created many new products that have become essential to our industry and community. If there was to be a cancer hazard associated with these new products, it would first be seen in the early 1970's. Vinyl chlo ride, then, is the first evidence that some of these chemicals that have been introduced can be carcino genic. Vinyl chloride may be unique--and we all hope it is--or it may be one of a series of new cancer-causing agents that are going to become ap parent. In this sense, vinyl chloride is similar to the canaries we used to send into the coal mines to see whether there was too much methane. You have to remember, too, that we are only be ginning to see the effects of vinyl chloride itself. Very few workers were employed in the vinyl chlo ride polymerization industry back in the late 1940's and '"'ly 1950's. Yet the cases of angiosarcoma now sho up are derived from that small group. The average duration of the cases now being seen is 20.5 years from onset of exposure. Since most vinyl chlo ride workers began employment in the 1950's and sixties, liver cancer that will occur in this much larger group will not appear unitl the 1980's and nineties. There also seems to be evidence of increased num bers of neoplasms [tumors] other than angiosarcoma, such as cancer of the lung, pharynx, brain, and the system that forms blood cells. If this is confirmed, then we are dealing with a broader cancer problem than we were first aware of. The last point I would make is that we do not know the level of vinyl chloride exposure associated with angiosarcoma. It may be low--1, 2, 3, or 4 ppm--or it may be that only 10 ppm or higher will give a significant number of cancers. If it's low, then we are in trouble because the fabricating part of the industry--where vinyl chloride is made into finished products and exposures are generally lower --employs many more workers. Estimates vary from 350,000 to 1,500,000. Dr. Wagoner: I think there are three other points we must recognize in regarding vinyl chloride as a test case. Once again, within a very short period of time, we'v een that data from animal studies, as in the case bis-Chloromethyl ether, predicted what we would see in humans. We produced angiosarcoma of 28 the liver and other tumors in animals with vinyl chloride, and now we are seeing these in humans. This reconfirms the importance of pretesting chemi cal agents on animals. Secondly, vinyl 'chloride is the classic example of the idea that the occupational environment cannot be considered in a vacuum. Over and over again we are seeing occupational health problems extended out into the general'population. The workplace is the best predictor of environmental causes of cancer. Finally, vinyl chloride raises a problem that has been completely overlooked in the past. As far as I know, there have been only one or two studies in the entire history of occupational medicine on the potential mutagenic, or chromosome-altering, prop erties of an agent. Q. What is the evidence for the mutagenic effects of vinyl chloride? Dr. Selikoff: There are few data so far, and I believe that they should be interpreted with caution at this time. We have found in very limited studies that w significant chromosome abnormalities are more often Ci present among vinyl chloride workers than among h* control subjects. Laboratory studies in Sweden and cn in the United States have also demonstrated the u mutagenic potential of vinyl chloride in bacterial test o systems. We feel, however, that broad conclusions are not warranted at this time though, obviously, o because of the potential importance of the subject, additional studies should be rapidly undertaken. I> Q. Thi liver p, Germa disease of angi eating Dr. Wt foreign govern: of angi a case in an o we foui premise lower t interval demic ( where ( we're facilitie Dr. Sel seeing i ter, ho' Q. Is t, ease"-- Left, Dr. Joseph Wagoner of NIOSH. Above, Dr. Irving Selikoff of the Mt. Sinai School of Medicine. Q. There are at least two pieces of evidence linking liver problems with work in fabricating plants--six German tile workers who are showing signs of liver disease and the two Connecticut workers who died of angiosarcoma. Has any other evidence from fabri cating plants appeared yet? Dr. Wagoner: Data have become available from the foreign literature, niosh put out a call to all foreign governments and scientists to alert us to'any cases of angiosarcoma, and, indeed, in Scotland we found a case in an individual who used polyvinyl chloride in an oil cloth factory. It is very similar to the case we found in Connecticut. If we accept the very basic premise that as you lower the exposure level, you lower the incidence of the tumor and lengthen the interval in which the disease is latent, then the epi demic of angiosarcoma in fabricating plants is some where off in the future. So it doesn't surprise me that we're not seeing as many cases in fabrication facilities. Dr. Selikoff: I would be worried, in fact, if we were seeing many at this time. Full judgment on this mat ter, however, will have to await further experience. Q. Is there such a thing as "vinyl chloride liver dis ease"--in other words, a precursor of angiosarcoma? Dr. Selikoff: Yes. This has been well demonstrated by Dr. Hans Popper and Dr. Louis B. Thomas. There is characteristic liver disease associated with vinyl chloride that appears both before the advent of angiosarcoma and, in some cases, seems to exist in its own right without angiosarcoma. The appear ance of the liver is quite characteristic, and there are a number of other distinct liver changes that go along with the condition. Last year this liver con dition was also described among people taking arsenic for treatment of psoriasis. It has appeared as well among vineyard sprayers in Germany who use arsenic. A capable pathologist will be able to recognize what we can now term vinyl chloride liver disease. Q. Why does angiosarcoma seem to show up in some vinyl chloride manufacturing or polymerization plants and not in others? Why aren't the cases dis tributed several tp each plant? Dr. Wagoner: I have a theory on this. The theory is that we have found them whenever we have looked hard enough. Dr. Selikoff: I think that's probably the best theoiy. I would add that we would not expect to find angio sarcoma in plants that first went into operation in the last 10 or 15 years. The experience of these facilities will have to be evaluated 5, 10, or 15 years from now. Support for Dr. Wagoner's judgment is also evident in the fact that angiosarcomas have appeared in so many different plants, indicating that they are unlikely to be something unique to the pro cess or materials in one or two plants. Q. Are there any optimistic developments that have come out of the whole vinyl chloride problem? Dr. Selikoff: I can make two pleasant observations about this unhappy situation. One is that a number of industry groups have made valuable contributions to the developing studies on vinyl chloride. I would particularly comment upon the research results of the Dow scientists. We at Mt. Sinai, in our own studies, have had the cooperation of the Goodyears!^ Company and the Union Carbide Company. Indus- K try's cooperative stance in general has been note- ^ worthy. Secondly, the maturity of many labor unions ^ was evident in the rapid response they made. The ^ cooperation of the Textile Workers of America; the ^ Oil, Chemical, and Atomic Workers; the Interna-^ tional Association of Machinists; the United Steel workers; the International Chemical Workers; the United Rubber Workers; the Industrial Union De partment of the afl-cio; and others has enabled sci entists to obtain information much more quickly than might otherwise have been the case. 29 Historical Hazards Things have changed a lot where vinyl chloride is concerned since this picture was taken in early 1974. Here, a safety inspector in a polyvinyl chloride plant uses a portable organic vapor analyzer to "sniff" for vinyl chloride leaks near a reactor. Under OSHA's emergency temporary standard (in effect between April 5 and December 31, 1974), he was not required to wear a respirator since vinyl chloride levels were apparently under 50 ppm. The meter appears to be registering about 30 ppm of vinyl chloride in the air. According to the permanent vinyl chloride standard now in effect, however, he must wear an air-supplied respirator. For a summary of the rapid vinyl chloride developments, see the article beginning on page 4. t 31 ustry sources have cited, as a kind of opiinote, data from an epidemiologic study unm b) ^abershaw-Cooper Associates for the ictur, Chemists Association. The overall 'ty rate for the workers in that study was less ould be expected for the general population, vinyl chloride problem, then, less serious than lly thought? agonen I think there are fallacies in that line oning. The Tabershaw-Cooper study includes ody who has as little as one year's experience I chloride plants, and they studied these peoen during the first year after they were exNow, there is no such thing as instantaneous . Biologically it is nonsense to expect to see a Stic effect resulting in death within one year, udy includes a disproportionate number of inals who have had an insufficient latent period Ich the cancer could become manifest. Natthey are seeing a deficit in the total number ths. have looked at their data, and we also see a :ant deficit of cirrhosis of the liver in this pop1. I have talked to the medical directors of the nies involved, and they tell me that they have tggressive screening programs for alcoholism, alism is highly associated with cirrhosis of the In this way, then, and in many other ways the yees `-died are more healthy than the general ition .t was used as a control group. That includes people who are in hospitals with and people who work in other industries with i risk of cancer. I think that if the workers d are looked at again in 10 years, the study isions will be the exact opposite of what they w. likoff: In general, we like to evaluate the expeof a group when it is "at risk." Because large ;rs of workers who are not currently at risk :luded in this study, we can't use it to evaluate will happen to people who are at risk. I'm ent that as further data accumulate and more rs are traced--a large number, after all, were aced in this study--appropriate conclusions will awn. Both Dr. Tabershaw and Dr. Gaffey ithors of the study] are competent and knowlble people, but it seems inevitable that indi1s who are not thoroughly familiar with the ications that go along with scientific data will ite the findings in ways in which they were not t to be evaluated. r. Selikoff, you have testified about toxic effects tyl chloride that were known as early as 1938. didnneople pay more attention to this evir at . time? In other words, how do we pre future vinyl chloride disasters? Dr. Selikoff: The evidence was indirect and limited, but more important, our concepts were undevel oped. By that I mean that when a substance is known to be biologically active in one organ system, we must at least admit the possibility that it may be active in other ways as well and look for such activity. It has been known for at least 25 years that vinyl chloride could have toxic effects on the liver. Today, with such information, we would feel that other biological effects, primarily cancer, would have to be taken into consideration. All substances now known to have some organ toxicity should be looked at as soon as possible with regard to their possible carcinogenic effect. This can be done through animal studies or through a combination of animal studies, epidemiologic studies, and clinical studies. If an agent is carcinogenic, it's obviously impor tant to know this as soon as possible. However, I think negative data would be equally valuable. We can't go running off in all directions at one time. It is important for us to know that some things are safe and that we can devote our very limited resources to those of which we are most suspicious. Dr. Wagoner: The Toxic Substance Control Act, which has been passed by both houses of Congress and is now held up in a House-Senate conference committee, addresses the very basic issues involved here. Must we continue to suppose that industrial chemicals are safe until proved otherwise and then go out after the fact to see the devastating effects? Or, is it more rational to pretest agents before they are introduced into the workplace? Q. The director of environmental health for a large chemical company once made this argument to me: Relatively few workers are exposed to the hazardous effects of vinyl chloride, but many lives are saved in other industries because of polyvinyl chloride products like hospital equipment. How do you re spond to that view? Dr. Wagoner: I think we can have our polyvinyl chloride products and a safe environment for the worker at the same time. I don't think these are mutually exclusive possibilities, and I don't think we should have polyvinyl chloride products if it means that as many as one extra person will die. Dr. Selikoff: The very fact that there are relatively few workers involved would suggest that the feasi bility for control is greater. We really have no op tions in the matter. Congress passed the Occupational Safety and Health Act to make sure that no worker should suffer ill health or risk his life as a result of occupational exposure. Dr. Selikoff and Dr. Wagoner were interviewed by George Clack. N W C!\ CJ O