Document r9RpM57mGr4gEVn3DOykBaJe

RUSS PENDERGAST March 5, 1974 F.Y.I. Alan Baker - Assonet H. Blalecki R. J. Delargey Dr. M. R. Gasque J. Hanrahan X. Dr. R. Henderson - N. H. D. Palm J. R. Ryan J. R. Wilkinson Many Workers Still Face Health Peril Despite Law 1 By JANE E. BRODY -__________ Thi recent discovery of fatal; For vinyl chloride, for ex-! liver cancer among vinyl' jchloride workers has focused renewed attention of govern- ment. labor, industry and medicine on the thwaands of j known, suspected tM as yet unsuspected health hazards 'that face SO million working Americans. f ` Despite the passage three ample, the existing Federal standard is 10 times higher than what most industrial users themselves adopted years ago. and la infinitely higher than the aere exnoeunt level that labor and university scientists rec ommend. ' New stsndsrds developed under the Federel law are being promulgated by the Department of Labor's Occupational Safety years ago of the Occupational and Health Administration Safety and Health Act, granting (OSMA.) at a rate of only one. every American the right to work without job-induced I threats to life and health, the: 'overwhelming majority of | a year. At the tame time, in dustry is introducing some 400 new chemicals each year, nearly all of which are untested for possible long-term effect* .workers are not yet protected: on the workers who handle by the law's provisions. For {lack of this protection, hun dreds of workers are /lying them. There is virtually no testing of combinations of substances that by themselves may be each day from occupational harmless but become deadly diseases. i The General Accounting Ofifice acknowledges that there jhas not been nearly enough when combined, tlthough a leading occupational hazardasbestos--is known to greatly increase the risk of lung can-: ter only in workers who smoke jmoncy and staff allocated to jmakr a dent in the vast prob- cigarettes. "The long-term effects of the jleAof occupational health. In ^^Pon, fundamental scion- jtific knowledge is lacking upon iwhich to base remedial actions, vast majority of chemical and physical agents used in indus try have not been proved, and practically no research is be ing conducted to find out what and without more funds the these effects are," Dr. Jeanne necessary research is not forth coming. Historically, occupational health has been a low-priority hi. Stillman and Dr. Susan M. Daum state in their new book. "Work i$ Dangerous to Your Health." But Dr. Irvin* J. Seltkoff, di item for both government and medicine. J rector of environmental sci ences at Mount Sinai School Yet, each year one of every 10 workers suffers a iob-related: illness or injury. The Public Health Service estimates that prolonged on-the-job exposure to toxic chemicals, dusts, noise, heat, cold, radiation and other, industrial conditions each year results in the death of at least: . 100,000 workers and the de velopment of disabling occupa tional diaeases in 330.000 more. Researchers In occupational health believe that countless thousands of others succumb to Insidious job-related diseases of Medicine, said. "For scien tists to worry about what we don't yet know when nothing . is being done about what we ' already know is a cop-out." He noted that even if"there-werry enough data to develop pro tective standards for all known and potential dangers, the La bor Department would be hard: put tp enforce them with only: 600 Federal inspectors and hy-j gienists to canvass nearly five, million workplaces. During its first eight months,O.S.H.A. inspector* visited 17,- not yet discovered by science. Industry sources estimate that only between 5 end 15 per cent of workers are covered by comprehensive company medical departments, which have the potential for detectJ^urork-related health threats. 743 workplaces. At this rate, it would take them more than' 200 years to visit each one1 once. If the staff were ex-` par.ded to the original projec tion of 2.000, it would still take about 50 years to com plete the rounds of workplaces. Inadequate Standards Enforceable Federal stand ards to protect worker health currently exist for only *50 of .the estimated 15.000 chemi cal and physical agents to which workers are .exposed, and experts in occupational health lay that most of these In thousands of plants throughout the country, work ers do not even know what chemicals they work with since, to protect trade secrets, the substances are given only code numbers. And unless a ederaJ standard exists, the campany is not required to monitor worker exposure toi -"'vir.in ***!* or to perform! periodic medical examinations of those exposed. "The act has done a treat deal to improve the worker's oerceptions about the situs-! tion. but it hasn't yet done; much to improve the situe* (tion." uid Anthony Mazzocchi. (legislative director of the Oil. fChemica! and Atomic Workers, International Union. I Franklin Wailick of die |United Automobile Workers, i iwfao wrote a book called. "The; lAmetican Worker An EndanIgered Species." Hid that for the [most part workers are ttUI 'The human guinea pigs for in dustrial processes." In interviews Sect week, la bor. industry, government and university sources agreed that (although the occupational Ihealth law was a giant and: [essential step in the right di* rection. the realities of current [Administration funding have 'deprived it of much-needed muscle. Under the act, the National Institute for Occupational Safety and Health fKLO.S.Hi was set up to survey indus trial health problems, conduct needed research and develop new standards for known anc potential occupational hazards. But in the wide bureaucrac;. of the Department of Health. (Education and Welfare, the in stitute has thus far been {treated like an unwanted step child. According to* a recent anal ysis by the Government Ac counting Office, a meage.- budget of about S24-nulIicn and a staff limited in size (SCO. and professional level have severely hampered the insu- jtute's potential accomplish- ;ments. As a result, in its first twe {and a half years, the institute has been able to develop th* 'criteria for only 16 new sunc- !ards for hazardous material; although the institute's list o: high priority agents exceed.1 400:-- ____ To handle "emergencies" like vinyl chloride, the institute has been forced to divert funds and personnel from other es sential but less immediate tasks, such as developing standards that might head oft | other vinyl chlorides tefore: workers succumb to their ef-! fects. Last year, the ordinarily' sedate and sober director of the Institute, Dr, Marcus Key, exploded with exasperation: j NJ.O.S.H. is not expanding, it Is shrinking. It is getting j the proverbial meat ax. . . .| Our present laboratory space isn't even adequate for any kind of research. It is sub standard. . . , We have been! frozen on hirings for mo*; of! our existence, and we are| losing key staff right and left l because we don't hive the! grade points to promote them.; . . . 1 don't think N.I.O.S H.j is a viable organization at tbit time" ! Dr. Key uid the situation had] not yet improved. "If any* thing, it's worn," he remarked.] The institute's efforts arPeft! not aided hy the fact that oc- CV i, \ cupational health hat been t" _pV> virtually ignored by the medical .profession, which regards it as [a iess-than-glamorous special ty. Only a handful of univer* .utiet have, departments ot> occupationaTheaJth and fewer, than a douB^fhysieians enter ,the Geld aadT year, the maijortty becoming company doc tors. The institute also faces the scientific problem of how to determine when a substance is safe. As Dr. E. Cuyler Hamstood or tlte Amencan Cancer Society uid: "Negative results in testing s substance for cancer-produc ing properties are meaningless, and a clever-enough researched can make almost anything in: duce cancer in animals, but' his findings may have no relevance to human exposure.' Rather than recommenc "safe" exposure levels. Di Hammond and Dr. Key believi that industry should adop protective work practices tha. eliminate worker exposure u all agents--whether or not they have been proved harmful. Such work practices were ecommended by the institute for 14 cancer-causing industria'i chemicals covered by an oner-! ency standard issued Iasi! spring. The institute advocate* s similar approach to viny' chloride, a gaseous chemic'a'j in the plasties industry that i j he last month has been linked' [to angiosarcoma of the liver.j . ,n ett'remriy rare cancer, iri (*> uw-fcere t fnnr (Jitlet Slants. I A further problem in eam-| ng worker orotection under! he act has been the slowness' of the Labor Depanment in ssuine new exposure standard* and ft* reluctance to assume full enforcement responsibili- ies. Thus far. the institute has acted on only two of the init.ute's 16 proposed standards -- asbestos and carcinogens-- ind in both cases the action resulted in a weaker standard than the institute had rec ommended. Under Administration pres sure -- and to the distress of : occupational health activities -- the Labor Department has {been seeking to turn enforce ment of the Federal regulations I back to state occupational [safety and health divisions. Robert E. Nagle, general counsel for the Senate Labor and Public Welfare Commit tee who is the main author of (he Occupational Safety and Health Act. said tht the states traditionally have had iittls in terest or expertise in occupa tional health fas opposed to safetvl. and that state officials are likely to be more suscep tible to pressure from local in- o\ ro MAR 7W4 vented tube from etch engine blows air at very high pressure and forces gravel away from the engine intake. Other operating problems include temperatures that are 50F to 60F be low aero, 60-fnph winds, and total dark ness in December and January in the High Arctic, Engines on airstrip equip ment such as trucks and snowplows are not turned off from Dec. 1 to Mar. 15. Tboc& the regionals, too, face fuel problems; all are predicting revenue in creases this year. They see their big gest growth potential in scheduled pas senger service, although no one is scoffing at the big bucks to be made in hauling drilling equipment-and beerto oil teams in the Arctic or to the offagain, on-again 96-billion James Bay hydroelectric project in northwestern PWA ships cattle to the Orient and oil-drilling The deaths of five workers in ten years seem linked to working on the plastic Federal officials met last week with plastica industry executives in Cleve land and Washington to try to deter mine whether the industry has un knowingly been exposing' some of its 6,500 blue-collar workers to fumes that can lead to a rare form of liver cancer known as angiosarcoma. The focus was on 28 of the 42 plants in the U- S. that make vinyl chloride or use it to produce fects on worky* of other industrial chemicals. "Tb*-cancer took 15 to 20 yean to dtvelopfnays one federal epi demiologist. Other chemicals could have smilar "latency" periods, he says, so there couldmore eruptions in the yean ahead. *1 hope we're not seeing the beginning of a health collapse." Tbe vinyl chloride ease is not the chemical industry's first encounter with OBHA over carcinogenics. Last May the agency invoked emergency standards for 14 chemicals (BW- May 19, 1973). Final rules for these mate rials went into effect last week, though both industry end labor are suing for equipment to the Arctic polyvinyl chloride resin (fvc), one of judicial review. the most common plastics. The prospect of new, petrochemical Quebec. Nordair flies there from Mon Tbe hearings grew out of tbe deaths venions of such health time bombs as treal, and Quebecair operates cargo- of four workers over the last six years "black lung" and mercury poisoning, only service. at a B. F. Goodrich Chemical Co. plant makes plastic industry leaders shudder. Cattle plane. In the eyes of many indus in Louisville, Ky. They could ultimately And indeed, new data presented at the try observers. Pacific Western is the bring costly new rules for the fvc in standing-room-only osha hearing by best run of the regionals. Its fleet con dustry, whose resins are used in such Italian researcher Cesare Maltoni, of sists of seven Boeing 737s, with three items as pipe, floor tile, phonograph Bologna's Institute of Cancer, leave more on order, plus two 727s, two long- records, and latex wall paints. "Im little doubt that vinyl chloride is car- range 707s, five Convair 640s, four Her provements in work practices will cinogenic-at least to rats. He exposed cules jet-prop freighters, and a few fly probably require a 100% increase in the 67 rats to air containing 250 parts per ing boats, pwa's operations range from work force," says Walter B. Connolly. million of vinyl chloride off and on for its scheduled passenger services to Jr., labor counsel for Firestone Tire & 52 weeks. By the end of 127 weeks, hipping cattle to the Orient and ex j Rubber Co., which operates pvc plants Maltoni reported, two had contracted tensive relief work in such places as Ni | in Pottstown, Pa., and Perryville, Md. angiosarcoma and nine contracted geria and Bangladesh. Scheduled pas- In any case, the current pvc hulla other forms of cancer. Many chemical aenger services account for roughly baloo is certain to spark new demands industry executives had downgraded 65% of pwa's revenues, charters for by organized labor for closer exam the importance of earlier animal test about 10%, and cargo services for the ination of the possible long-range ef results because the dosages were masremaining 25%. Its cattle plane is typical of pwa's willingness to provide specialized ser A solvent that crippled chemical workers vices to meet special needs. A conven tional Boeing 707-320C, the plane can Last August, Thomas F. Meade, 22, zeroed in on an ink solvent, methyl be equipped with either 13 stalls hold ing about 85 1,000-lb. cattle or double was stricken with a nerve disease after butyl ketone, used in applying decora two years of work at Columbus Coated tive patterns, as the most likely culprit. tiers of pens that will accommodate a Fabrics Co., a subsidiary of Borden, While continuing to monitor the great many more smaller animals. Donald N. Watson. pw.\ president, says Inc., in Columbus, Ohio, that makes vi plant's air, they banned the use of MBk. nyl-coated fabrics for luggage and wall The plant's managers have switched t that tbe plane has carried as many as coverings. The disease, diagnosed as a substitute, improved ventilation, i 700 cattle from Toronto to Athens. peripheral neuropathy, left Meade sued respirators to print shop worker Tbe real keys to profits for pwa and crippled, and today he wears leg and moved lunch areas away from the other regionals, however, have braces. He is the most severely af work areas. been jets and charters. The jets fected of some 130 workers at the plant But Corwin Smith, president of Lo boosted available seat-miles on routes who have suffered symptoms of the dis cal 487 of the Textile Workers Union of with good load factors, and the char ease. The lesser symptoms include America, which represents the plant # ters gave the carriers the capability to weakness and loss of coordination. workers, is not satisfied. He says that use their aircraft more economically. When the symptoms became wide 26 numbers are still out with the dis Keith Miller, executive vice-presi spread last summer, state health offi ease, that eight of them are severeh dent of Eastern Provincial Airways, cials tested the nerve responses of the crippled, and that three workers whose estimates the seat-mile cost on a 109- plant's 1,124 employees and told 200 of condition improved are now sick again. passenger 737 at 2.2c a mi., compared them to stay home for two months. On Feb. 9, the local struck the plant as with 5.5c for each mile on the 41-seat Many others stayed home, too, out of negotiations collapsed on a new con Handley Page Heralds the 737s are re fear. By December, most employees tract; one of the union demands was a placing. The break-even load factor on had returned, and many who had "proper work environment." Say.- the jets is 42%, vs. about 80% on the prop planes. "The stimulation of a 737 ia very substantial," Miller says. showed neuropathic symptoms ap Smith: "People here don't kno--' peared well again. whether they will be crippled in the fu Meanwhile, Ohio health officials had ture or not.'' O L I 1320 tive, on the order to 5,000 to 30,000 ppm limit recommended since 1972 by nors, Jr, general manager of the Plas ppm. the American Conference of Govern tics Div, of Diamond Shamrock Chem The bombshell The cancer crisis hit the ment Industrial Hygienists. In 1970, ical Co., which also observes that limit, hrinyl industry just a month ago. Not* Italian researcher Dr. P. L. Viola re "there are not enough fumes in the air ring an unusual number of liver ail ported that rats exposed to heavy doses to smell." Where concentrations are ments among the Louisville plant of vinyl chloride developed malignant higher, he says, "we have ordered our workers, B. F. Goodrich physicians ran tumors. Several European chemical men to wear gas masks." blood tests last fall on the 271 workers companies banded together to support Vinyl fumes arise partly from leaks in the plant's pvc facility and found 55 research by Maltoni, and in the U. S., in pipes and valve^But another likely with apparent liver abnormalities. The the Manufacturing Chemists Assn, be source is the polymerization vessels, company reviewed medical and insur gan to discuss an industry-wide re when they are openSRer cleaning and ance iccuiuod by Jan. 16 had discov search program. A year ago, the MCA maintenance. NIOSH officials are con ered three oaths since 1971 that were set up an animal test program that will centrating now on the polymerization attributable to angiosarcoma. Federal not be completed until late 1975. The process, but they ^fian to extend their health officials estimate the annual association also contracted with Taber- studies eventually to monomer produc death toll id the U. S. from this rare sfaaw-Cooper Associates, of Berkeley, tion, as well aa PVC fabrication and form of cancer at only even consumer use of pvc about 20. On Jan. 29 fur products. ther review by Goodrich Since safe limits for vi turned up a 1968 death nyl chloride are unknown, (two more cases, includ NI06H is emphasizing safe ing a 1964 death, were work practices rather identified this week). than arbitrary concentra The company's top tion limits. Its recommen management had already dations for the Louisville decided on public disclo plant, for example, in sure. It reported the situ clude such things as over ation to the National In- head cleaning, daily show atitute for Occupational ers and clothing changes Safety & Health and to for workers, and ex the Kentucky Labor Dept. panded air monitoring. It also began notifying Pinning It down. Goodrich's employees in all of its vi Louisville plant uses nyl chloride and pvc oper about 50 different chem ations, and it sent a re icals, and there is no proof lease to the press. "We of a direct link between are doing our utmost to vinyl chloride and the express our real and liver cancer cases. But serious concern," says NlOSH officials are certain John J. Bell, the com that the link exists, and pany's public affairs direc A B. F. Goodrich safety inspector uses a chemical "smtfer" to check the mca's Johnson con tor, "and yet prevent any whether vinyl chloride fumes art leaking from a polymerizing reactor. cedes that "vinyl chloride undue panic." is the material of primary' NlOSH, which had immediately sent Calif., to check the available death suspicion." Only two other carcinogens, experts to Louisville, held a briefing records of workers at other vinyl arsenic and thorium-232, are proven early last week in Cleveland to tell plants. "So far." says Kenneth John causes of angiosarcoma, and medical management and labor leaders in the son. mca technical director, "the results records on the four Goodrich workers industry what it knew about the car haven't been subjected to statistical showed no exposure to either. cinogenic effects of vinyl chloride. And analysis." Both niosh and industry officials on Friday, many of the same execu To Dr. Irving J. Selikoff, the history hope, though, that the link is peculiar tives showed up in Washington for the shows that "our approach to the prob- to Goodrich's Louisville plant. Says OSHA hearing. The federal agency will determine whether the situation war NIOSH hopes that the NIOSH Director Marcus M. Key: ''We still hold to the possibility that the rants either an emergency standard or cause is a combination of cause could be a combination of two or at least a start on the regular rule- factors at only one plant making process. three things acting together ir. me manufacturing process." The attitude of organised tabor was lem was, shall I say, leisurely." Seli The Louisville plant is Goodrich's a maj r concern. Anthony Mazzocchi, koff, director of environmental medi oldest pvc plant and, unlike most legislative director of the Oil, Chemical cine at New York City's Mount Sinai newer plants, is enclosed. It also has a k Atomic Workers, who attended the School of Medicine, has been a frequent number of older workers on the line. NlOSH briefing, says: "It's apparent critic of industrial health practices, and Some workers may have been affected we're dealing with a carcinogen. We one chemical executive calls his re by an epidemic of hepatitis that swept want to reduce exposure to zero. But mark, made at the osha meeting, the city a few yean ago. A number of we have a wait-and-see attitude right "hindsight." other rubber and chemical plants, and now." Belatedly or not, some Pvc producers their fumes, are located nearby. And While the fatalities at Louisville have been tightening up their oper the plant is one of the few that uses vi- came as a shock to the industry, vinyl ations. Goodrich, for example, says it nylidene chloride as a copolymerizing chloride has been suspect for a long had already done, or was doing, most of agent. Rudolph Jaeger, a physiologist time. Some 15 years ago Dow Chemical the things niosh recommended after at the Harvard School of Public Health, Co., based on its own studies, adopted visiting the Louisville plant, including told the OSHA meeting that test data an average exposure limit of 50 ppm sticking to a 50-ppm average exposure appear to point to that chemical, too, as for its workere-well below the 200- limit. "At 50 ppm," says Harry Con a carcinogen. O L I 1321 t?ChnCh W;v BLSIWESS WtFK FlOfU*-, 1974 101 MAR 7 1974 RECEIVED FEB 25 1974 STATEMENT OF THE ^ MANUFACTURING CHEMISTS ASSOCIATION BEFORE THE OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION ON POSSIBLE HAZARDS OF VINYL CHLORIDE MANUFACTURE AND USE FEBRUARY 15, 1974 - The Manufacturing Chemists Association (MCA) is a non profit trade association having 174 United States irember com panies representing more than 90 percent of the production capacity of basic industrial chemicals within this country. With respect to vinyl chloride, the subject of this hearing, over 97 percent of the production capacity reported by Chemical and Engineering News in May 1973 was in our members' plants. For the polymer plants, the corresponding figure was then nearly 88 percent. Vinyl chloride (VC) is a chemical derived ultimately from petrochemical feedstocks and chlorine. Of the 5.2 billion pounds of the monomer produced by U. S. industry in 1972, all but a small fraction -- less than one percent -- was used in the pro duction of various plastics -- primarily polyvinyl chloride (PVC), OLI 1322 <1 ' --2 -- * but including a wide variety of co-polymers with other monomers. Among thf plastics, only the production of polyethylene exceeds that of PVC. The importance of PVC production is not measured just by th value of the unprocessed polymer, but more properly by the almost universal dependence of nearly every branch of industrial and commercial activity upon products and components fabricated from this plastic. With this statement, we are submitting a description of the industry and its products that appeared in the December 1973 l^ssue of Plastics Engineering, and we ask that this reprint be made a portion of the record of this hearing. This report makes it clear that the VC/PVC industry involves a wide variety of chemicals -- initiators, catalysts, plasticizers, stabilizers, antistatic agents, fillers, pigments, and a host of other special ized, but generally very minor, additives. Under such circumstan ces, the identification of any adverse health effects among the employees of a vertically-integrated VC/PVC plant with a specific causative agent becomes complex. A few more statistics concerning the industry may be helpful. The U. S. VC/PVC industry has been operating over forty years, and over the past five years has shown an annually compounded OLI 1323 -3 growth rate of 14 percent -- a rate of growth that is expected to tapbr off only moderately in the next few years, to about 11 percent, u. S. production now represents about one-fourth of the world total. Synthesis of the monomer is conducted in fourteen U. S. plants, and thirty-seven plants are engaged in polymeri zation. It is estimated that about 1,500 workers are employed in monomer synthesis, and an additional 5,000 in polymerization operations. It is difficult to estimate the number of workers employed in converting, molding, and fabricating these polymers, but they are numbered in the tens of thousands, working in thousands of plants. It has been estimated the wholesale value of th annual output of fabricated products is over three billion dollars. MCA, as a regular and continuing service to its members, has long had active programs in occupational health and safety. Its past and current activities with respect to vinyl chloride are a natural outgrowth of these progtams. MCA's Safety and Fire Pro tection Committee is now in its twenty-eighth year. Among its oth r activities, it has prepared MCA's highly-respected series of Chemical Safety Data Sh ets for commodity ch micals throughout this OLI 1324 4 period. One on vinyl chloride -- SD-S6 -- was first issued in 1954, and was last revised in 1972. * A Medical Advisory Committee was formed in 1946, later reconstituted with the addition of industrial hygiene engineers, toxicologists, statisticians and other specialists in employee heal.th, and renamed the Occupational Health Committee. Additionally, MCA is prepared to administer special programs on behalf of groups of interested companies, in instances where only a limited number are directly involved. Thus, in 1966, when companies were alerted by the Europe an reports of an occupational disease among PVC polymerization kettle cleaners, a project was established at the University of Michigan's School of Public Health to determine the nature, extent, and etiology of the condition known as occupational acroosteolysis. The results of this study have been published by Drs. Harold J. Magnuson, Bertram D. Dinman and others, in a series of three papers2'3'^ in the Archives of Environmental Health (January 1971). Although the role, if any, of vinyl chloride in the causation of this condition could not be defined, the industrial hygiene con trols and improved work practices adopted by the industry have led to a decline to almost zero in the number of new cases of even very mild forms of this disease. OLI 1325 * /' / * -5It was in an effort to develop an animal model of this condition that the first observations of possible carcinogenesis by vinyl chloride were made. Or. P. L. Viola, in a report pub lished in March 1970^, reported that rats exposed to 30,000 ppm vinyl chloride vapors for four hours per day, five days per week for a year,showed "degeneration of the skeleton and connective tissue with histopathological pictures similar to those observed in human acroosteolysis of the hands." In his paper, no mention is made of the appearance of any malignant tumors. A few months later, however, at the Tenth International Cancer Congress^, Dr. viola briefly described observations of malignant, tumors in the ear canals of rats subjected to an exposure protocol almost identical with that in his earlier paper. He also report d tumors in the lungs and bones of these rats, but closed his abstract with the specific disclaimer: "No implications to human pathology can be extrapolated from the experimental model report d in this paper." MCA invited Dr. Viola to come to the United States as a gu st f the industry, for a discussion with U. S. occupational health experts. On May 5 and 6, 1971, at a meeting with MCA's ^Occupational Health Committee, he discussed his more detailed OLI 1326 -6 report then in press71 and referred to other studies oosipieted or underway. Dr. viola spoke of these unreported studies only in rather general terms, and declined to reveal details. He acknow1 dged that his vinyl chloride was of low purity, but expressed his personal opinion that it was the vinyl chloride, per se, and not any impurities, that was responsible for the pathology he was observing. He claimed to have seen tumors in rats exposed to 5,000 ppm, but expected the results would be negative at half that level. In his opinion, the 500 ppm TLV provided an adequate margin of safety of employees from the tumor induction he had s en in rats at the higher levels. We are not aware of any furth r publications by Dr. Viola on this subject. The disparity between Dr. Viola's findings and the rela tively low toxicity reported by earlier researchers was immediately recognized. For many years, vinyl chloride monomer was considered to be very low in toxicity, both from single and repeated exposure. B cause of its volatility, inhalation was considered the only im portant route of exposure for workmen. The high flammability of VCM has been considered to be a more serious hazard than inhala tion. From the earliest lists until 1962, the American confernce of Governmental Industrial Hygienists (ACGIH) recomm nd d that the time-weighted averag ,long-term, 7-8 hour daily exposure OU 1327 -7 of workmen to vinyl chloride not exceed 500 ppm v/v (1270 mg/m^). This recommendation was based on single exposure studies on animals and on human experience. Recommended time-weighted aver age concentrations are published by the ACGIH in an annual list of "Threshold Limit values" (TLV). A TLV was considered by this group to "represent conditions under which it is believed that nearly all workers may be repeatedly exposed, day after day, with out adverse effect." In 1963, the ACGIH modified their recommendation so that 500 ppm was to be a maximum concentration (or ceiling) rather than a time-weighted average. It is this standard that is in the 1970 TLV list promulgated by OSKA on May 29, 1971, as a national con sensus standard. The change from a time-weighted to a ceiling standard was, in part, due to the publication by Torkelson, Oyen and Rowe f th results of six-month repeated inhalation studies on laboratory animals. These authors reported slight reversible liver injury in rats xposed seven hours per day to 100 ppm, and recommended that the time-weighted average exposure of workers not exceed 50 ppm. This recommendation was not deemed appropriate by Lester# Greenberg, and Adams, however, who did not consider significant injury to have resulted in rats which they had repeatedly exposed to 500 ppm. OLI 1328 -8- In 1970, the ACGIH proposed reduction of their recom mend d TLV to a time-weighted average of 200 ppm primarily on th basis of work reported by Kramer and Mutchler^. The authors reported evidence of clinical findings in workers exposed to tim -weighted average concentrations of 300 ppm vinyl chloride for many years. In 1972, the ACGIH took vinyl chloride from the list of Intended Changes and revised the value in their regular list to 200 ppm (510 mg/m^). This value remains the recommended value in the 1973 list. A copy of the documentation for the ACGIH TLV for vinyl chloride is provided as an attachment to this statement. In view of these developments, it was recommended that MCA convene a conference of vinyl chloride manufacturers to dis cuss the prospect and feasibility of establishing an industrysupported research program. This meeting, attended by representa tives of U. S., Canadian and European firms, took place on November 16, 1971. On the initiative of companies attending, a research project was formed with MCA participating in an administrative role. A contract with the Industrial BIO-TEST Laboratories, Inc., of Northbrook, Illinois, was signed on February 1, 1973. The comPl te. experimental protocol is submitted as an attachment to this statement. The specific goals in mind were; OLI 1329 -9- 1. to attempt to duplicate the European observations with vinyl chloride of a source and quality characteristic of the U. S. industrial product; 2. to extend these studies to two other species of laboratory rodents -- mice and hamsters, to determine whether the responses of rats might be species-specific; 3. to develop dose-response relationships with higher limits of statistical confidence, to permit estimation of poten tial risks at occupational levels of exposure with greater pre cision; and __ _ 4. to determine what the no-response level is. In these studies on rats, mice and hamsters, groups of 100 male and 100 female of each species (600 animals at each ex posure level) are being exposed to either 0 (control), 2,500 ppm, 200 ppm, or 50 ppm of vinyl chloride monomer, seven hours per day, five days per week, for twelve months. They will then be observed for an additional twelve months (six months for mice). These animals will not have food and water during exposure. This "lifetime" study is designed primarily as a cancer study and will include only a limited amount of other observations. B cause Viola's studies involved simultaneous exposure of food, wat r, and bedding, a separate group of 100 rats of one on s x is being ex- OLI 1330 ' - 10 pos d to 2,500 ppm along with their food, water, and bedding. This has been included because of the possibility that a reaction of the vinyl chloride monomer with either the food, water, or bedding may result in a toxic reaction product. Although animal exposures started in July 1973, equipment t problems gave rise to a number of uncertainties that might have compromised the validity of the results, hence the initial group of animals was discarded and a new set procured. The new exposures got underway on September 10, 1973. Up to this time, no significant results have been obs rvd in this study, nor would the appearance of any tumors be expected in so short a time. We will keep both OSHA and NIOSH informed as this study progresses. Recognizing that there must always exist a substantial degree of uncertainty in extrapolating the results of animal studies to the evaluation of workplace hazards, MCA has contracted with Tabershaw-cooper Associates, (TCA) of Berkeley, California, to con duct a study of the causes of death in vinyl chloride and polyvinyl chloride production workers. The objectives are: 1. to compare the mortality of individuals who have worked in vinyl chloride plants with that of the general popu lation, corrected for area, age, and sex; OLI 1331 - 11 - 2. to compare mortality patterns within the popu lation of vinyl chloride workers, based upon estimated occupational exposure; and 3. to compare mortality among vinyl chloride workers with the mortality of other occupational groups which TCA has studied. ` This study is now in its eighth month, and a final re port is expected to be issued in April. A copy of the protocol is submitted with this statement. Although the mortality statistics are as yet incomplete, and have not been analyzed, a preliminary review of the current data from all plants, other than the one concerning which the B. F. Goodrich Chemical Company has made a public disclosure, fails to show any obvious departure from the pattern and incidence of the deaths that would be expected among a population of the kind that has been the subject of this survey. We will, of course, provide OSHA and NIOSH with the final report and alert them promptly should any significant evidence of occupationally-related deaths appear earlier. MCA's first direct contact with NIOSH specifically on vinyl chloride led to a conference between an industry delegation, OLI 1332 - 12 including a European representative, and Dr. Marcus Key and staff n July 17, 1973, at which time the MCA program was presented in some detail, and study protocols, industry statistics, and select- d items from the scientific literature were provided. Under these circumstances, the VC producing and consum ing companies participating in the MCA-administered program were understandably greatly concerned when informed on January 22 by the B. F. Goodrich Chemical Company of the events that have led to the hearing now in progress. A meeting of the representatives f these companies was held on January 25 under MCA auspices to receive a comprehensive report from Goodrich, and to plan and implement any necessary steps not only for the protection of their workers, but also to hasten the resolution of remaining uncertain ti s. MCA then immediately contacted NIOSH and, both by tel phone and by confirming letter, gave assurance of full cooperation and support in their investigation and development of recommenda tions for the control of hazards from this source. MCA publicly announced that it is temporarily withdraw ing its Chemical Safety Data Sheet for vinyl chloride, which r cognized Dr. Viola's work, but stated that "... many years of industrial experience with human exposures to concentrations OLI 1333 - 13 frequently far above current standards have not demonstrated any carcinogenicity to humans." MCA will expedite the reissue of this data sheet, revised as necessary to reflect new knowldege concerning possible hazards of vinyl chloride exposures. A copy of a February 6, 1974, news release on the withdrawal is attached. As discussed herein, manufacturers are aware of the pot ntial hazard of vinyl chloride and, we are informed, are voluntarily taking steps to reduce employee exposure. Substantial research is now in progress, the results of which they believe will provide a firm basis for any standard applicable to VC/PVC manufacture. Therefore, it is their recommendation that OSHA proceed under the provisions of Section 6(b) of the Act. On behalf of its producer members, MCA pledges full cooperation with both N10SH and OSHA as they attempt to define the hazards now tentatively identified with vinyl chloride, and develop standards that will assure the safety of workers in this industry. OLI 1334 LIST OF REFERENCES 1. PVC Primer. Plastics Engineering. 26-40 (Dec. 1973). 2. Dinman, B. D.; Cook, W. A.; Whitehouse, W. M.; Magnuson, H. J.; Ditcheck, Theodore: Occupational Acroosteolysis I. An Epidemiological Study. Arch. Environ. Health. 22. 61-73 (Jan. 1971). 3. Cook, W. A.; Giever, P. M.; Dinman, B. D.; Magnuson, H. J.: Occupational Acroosteolysis - II. An Industrial Hygiene Study, Arch. Environ. Health. 22, 74-82 (Jan. 1971). 4. Dodson, V. N.; Dinman, B. D.; Whitehouse, w. M.; Nasr, Ahmen N. M.; Magnuson, H. J.: Occupational Acroosteolysis - III. A clinical Study. Arch. Environ. Health. 22, 83-91 (Jan. 1971). 5. Viola, P. L.; Pathology of Vinyl Chloride. Medicina del Lavoro. 61, 174-179 (March 1970). 6. Viola, P. L.: Cancerogenic Effect of Vinyl Chloride. Presented at the Tenth International Cancer Congress. Houston, Texas (May 22-29, 1970). 7. Viola, P. L.; Bigotti, A.; Caputo, A.: Oncogenic Response of Rat Skin, Lungs, and Bones to vinyl Chloride. Cancer Research. 31. 516-522 (May 1971). 8. Torkelson, T. R.; Oyen, F.; Rowe, V. K.: Am. Ind. Hyg. Assn. J. 22, 354 (1961). 9. Lester, D.; Greenberg, L. A.; Adams, W. R.: Am. Ind. Hyg. Assn. J. 24, 265 (1963). 10. Mutchler, J. E.; Kramer, C. G: Report on Relation of Exposure to State of Health of Dow chemical Workers, Gordon Conf., Tilton, N. H. (August 1968). OLI 1335 LIST OF ATTACHMENTS A) PLASTICS ENGINEERING PRIMER/PVC Reprint from December 1973 Plastics Engineering B) Viola, p. L. - Pathology of Vinyl Chloride C) Viola, P. L. - Cancerogenic Effect of Vinyl chloride D) Documentation for ACGIH TLV for Vinyl Chloride E) MCA News Release #3791 F) Revised Protocol for Animal Exposure Studies Industrial BIO-TEST Laboratories, Inc. G) MCA Neve Release #3814 H) Protocol for Epidemiology Study Tabershaw-cooper Associates, Inc* I) MCA News Release #3835 MCA Statement at OSHA Hearings/Vinyl Chloride February 15, 1974 OLI 1336