Document xdkjnOLqoqzVG8Ko3MD1j3G01

CHINA REPORT OF VISIT TO GULF PLASTICS CORPORATION April, 1974 R. L. Gibson, M.D. ' '`w . ' -V- < '*;*'* >-.- -''jSS* j ^r J$T 1jfj- *a*r * - CUSAROSS 00196 -EfUWIt^ REPORT OF VISIT TO CHINA GULF PLASTICS CORPORATION April, 1974 ''k - / Roy. L. Gibson, M.D. CUSAROSS 00197 TABLE OF CONTENTS I, S umma ry II. Recommendations Ill. Background A. Vinyl Chloride B. Methyl Butyl Ketone C. Retail Meat Wrappers D. Acroosteolyais E. Minamata's Disease IV. Vinyl Chloride Research V. Union Attitudes in the U. S. VI . U. S. Contacts VII . Taiwan Contacts VIII . Occupational Health Agencies and Regulations in Taiwan IX. China Gulf Plastics Corporation A. Toufen Factory B. Taoyuan Plant C. Kueishan Plant X. Taiwan VCM Industrial Corporation A. Kaohsiung Plant B. Toufen Plant XI. Conclusions XII . Re ferences Page 1 2 6 13 15 17 19 23 25 36 40 44 CUSAROSS 00198 f* 4 'A... "V. v CUSAROSS 00199 SUMMARY In the U. S. the National Institute of Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA) have given top pri ority to vinyl chloride since January of this year when the B. F. Goodrich Chemical Company of Louis ville, Kentucky reported that three employees who had worked in the manufacture of polyvinyl chloride resins for over twenty years had died of angiosarcoma of the liver. Subsequently industrywide investiga tions h^ve disclosed several more cases of this rare liver cancer. NIOSH responded by rejecting a threshold limit for vinyl chloride and recommending that any em ployee exposed to measurable amounts of vinyl chloride should wear an air-supplied respirator. On April 5th OSHA issued an emergency health standard reducing the TLV for vinyl chloride from 500 ppm. to a 50 ppm. ceiling level and advised industry that enforcement would begin immediately. Several research studies, sponsored by industry, government and universities are currently underway to define the extent of the problem and safe exposure levels. Preliminary findings seem to indicate that these levels will in all likeli hood approach zero. Visits to CGPC manufacturing facilities in Taiwan re veal potential exposures to a variety of chemicals in cluding vinyl chloride monomer and polymer, solvents, mercury and stabilizer compounds and actual exposures to these chemical agents and others were confirmed by the industrial hygiene survey. The need to establish medical and environmental surveillance procedures simi lar to those presently proposed in the U. S. is appar ent and appropriate medical and industrial hygiene engineering recommendations are made. Engineering and work practice procedures to reduce these chemical exposures should receive top priority along with the medical examination programs which are necessary to furnish evidence of a successful environmental effort. At the same time CGPC will need to provide trained personnel and adequate medical facilities to carry out these tasks and proposals are set forth to ac complish these objectives. \1 \ -1- CUSAROSS 00200 RECOMMENDATIONS '--A Medical Considerations 1. The medical facilities at Toufen Factory should be ex panded to provide at least two physicians' offices, examining rooms and a toilet. 2. A second full-time, English-speaking physician should be hired as soon as possible primarily to carry out the preventive medicine program. Preferentially he should be based in Toufen but cover all the plants by making periodic visits. At an early opportunity, once CGPC is satisfied with his performance, he should be sent to the U. S. for a minimum of one month's training under the auspices of the Gulf Medical Department. 3. As soon as the medical personnel and facilities are available CGPC should initiate programs of preemploy ment and periodic physical examinations to be con ducted on-site at the Toufen Factory and extended when practical to other CGPC locations. These programs should begin as soon as possible this year. 4. The nurses at the Toufen Factory should be trained to perform urinalyses, initially using dip-stix (Ames) tests, and possibly later doing microscopic urinalysis. 5. All workers should have a standard preemployment phys ical examination including a medical history, physical examination, chest x-ray, serology and urinalysis. Consideration might be given to translating the Gulf Medical Examination Form (Gulf 56118B) into Chinese for this purpose. 6. All workers exposed to toxic chemicals including sol vents, mercury, stabilizer dusts, VCM and PVC should have preplacement and annual physical examinations. The Gulf Medical Form can also be used for these exams and contains questions pertinent to the toxic symptoms and signs resulting from these chemical exposures. For example, these exams should include a.medical history and physical examination with emphasis on the following items: S olvent s - headaches; nausea, dizziness; skin and mucous membrane irritation; urinary symptoms and signs relative to the cardiorespiratory, gastro intestinal and genitourinary systems. Mercury - weight loss; insomnia; tremor; personal ity change; loss of appetite and urinary symptoms and signs. 2- - i \ CUSAROSS 00201 Dus t s - loss of appetite, metallic taste; consti pation; insomnia; weakness; irritability; muscle and joint pain; abdominal pain; wrist drop; and symptoms and signs relative to the respiratpry and genitourinary systems. VCM, PVC - alcohol intake; hepatitis; previous chemical exposures; blood transfusions; symptoms and signs relative to the gastrointestinal sys tems with particular attention to the liver. All workers receiving these annual examinations should also have a urinalysis, complete blood count, serology, and chest x-ray. In addition, the following groups should have studies done as follows; Solvent Workers (100 estimated) - An annual SMA-12 profile blood test. Stabilizer Dust Workers (30 estimated) - blood lead analyses done initially to assess exposures fol lowing engineering controls. The need for further testing will be based on the results of these initial tests. VCM Workers (40 Toufen and 220 TVCM plants estimated) Annual SMA-12 profile, annual bilateral PA hand x-rays on all current and former reactor cleaners only. PVC Workers - (44 Toufen and 80, Taoyuan estimated) An annual SMA-12 profile. If the VCM or PVC workers have been exposed for 10 years or more in any company then the laboratory stud ies should be repeated every 6 months. In general, if one or more tests are abnormal the studies should be repeated as soon as possible. If they remain abnormal the worker should be removed from the exposure and the cause of the abnormality investigated. If the repeat test is not abnormal, it should be rechecked in 6 months. 7. An attempt should be made to secure a copy of the death certificate as soon as practical following the deaths of all VCM and PVC employees and former employees whenever possible. Copies of these certificates translated into English should be reviewed by the CGPC medical advisor for suspicious causes of death. Further inquiry into these cases may be necessary. -3- CUSAROSS 00202 8. A system of recording sickness and accident absenteeism should be established. Such records should indicate both frequency and severity rates for the total em ployee population as well as specific exposures of interest, e.g. VCM, PVC, solvent, dusts and mercury. 9. The new occupational safety and health act for Taiwan should be translated Into English and reviewed by CGPC and the Gulf Medical Department as soon as possible. 10. An oxygen resusitation and aspirator should be purchased for the Toufen Medical Department. 11. First-aid equipment should be placed in key locations in the plants and maintained by safety or medical per sonnel. All supervisory personnel should be given a formal first-aid course on-site. 12. Vehicles on-site should be equipped for stretcher cases and stretchers should be available. Industrial Hygiene Considerations 1. Dr. Robert Cheng's recommendations to reduce exposures to solvents, mercury, stabilizer dusts, VCM and PVC should receive top priority and be implemented as soon as possible. It seems apparent that most, if not all, of the recommendations set forth in the NIOSH health standard for the manufacture of synthetic polymer from vinyl chloride will soon become U. S. regulation and CGPC should consider instituting these procedures in a practical, step-wise fashion. 2. An environmental surveillance program as recommended by Dr. Cheng should be initiated as soon as equipment is available but the sooner the better. Initially environmental measurements will have to be done fre quently until the exposures are defined and within acceptable limits. 3. One or more employees should be assigned responsibility for the environmental surveillance program for all plant locations. In view of the scope of the CGPC operations, the inherent health risks, the inter national publicity on VCM toxicity and the absence of industrial hygiene backup in Taiwan, I recommend that one employee, preferably a chemist or engineer, who speaks and understands English, be sent to the U. S. for a minimum of 3 months for intensive industrial hygiene under the auspices of the Gulf Medical De partment. This will improve the quality of the i - -4- CUSAROSS 00203 program, establish lines of communication and put CGPC in an advantageous position when dealing with the DOL and/or NHA. Dr. Cheng should return to Taiwan later this year either during or following the engi neering changes and reevaluate the in-plant .environ mental situation. 4. Records should be kept in writing both in Chinese and English of the results of all environmental monitoring and retained indefinitely. 5. Employees should be advised in writing of the risks of all toxic exposures and advised to report all related symptoms and signs immediately. 6. Each plant location should request from the Medical Department those Health and Safety Data Cards perti nent to its operations. At the same time a list of all chemicals purchased by each plant should be avail able in the plant for review. 7. Approved ear defenders, either muffs or plugs, should be available for workers exposed to noise exceeding 90 DBA. 8. Bacteriological examination of "potable" water sources at all plants should be done periodically, but not less than 4 times yearly depending on the findings. 9. Treatment facilities for all human and industrial waste should be given a high priority. 10. Access should be restricted by posting notices to all potentially hazardous areas, particularly those areas with VCM exposures. 11. Workers In potentially hazardous areas should not be permitted to eat on the job under any circumstances. 12. Hand-washing and shower facilities should be readily available to workers at each facility and plant location. 13. All workers should be issued lockers. 14. An educational effort should be made to promote per sonal hygiene measures in the plants. 15. Uniforms should be changed frequently and consideration given to a Company-sponsored laundering program to assure safe handling and to. avoid contamination in the homes of the workers. '-UT -5- CUSAROSS 00104 BACKGROUND VINYL CHLORIDE On January 24, 1974 the B. F. Goodrich Company announced that it was investigating the possibility that the cancer deaths of three workers at a plant in Louisville, Kentucky were related to their work with polyvinyl chloride. The diagnosis of a rare liver cancer, angiosarcoma, was con firmed by autopsy in all three cases. Previous to the public announcement which was widely reported in the press, ^ Coodrich medical representatives had informed Kentucky health officials and the National Institute of Occupa tional Safety and Health (NIOSH). Both organizations immediately responded by sending teams of experts to the plant. At the same time an effort was initiated to deter mine the extent of angiosarcoma in the U. S. and foreign countries with similar manufacturing processes. The Labor Department also responded by proposing an emergency fact finding hearing to be held on February 15th to examine the extent of worker exposure to vinyl chloride and by sending industrial hygienists to the plant to determine if there was a violation of federal standards. By mid-February the Industry survey had disclosed 3 more cases of angiosarcoma and 50 abnormal liver tests in workers exposed to polyvinyl chloride at the Goodrich Plant in Kentucky. On February 19 the Kentucky Standards Board at an emergency meeting adopted a 50 ppm. time-weighted average (TWA) and a ceiling value of 75 ppm. for 15 minutes for vinyl chloride.^ A value of 200 ppm. without use of protective equipment was set as an imminent danger situa tion. The value of 50 ppm. was based on animal toxicologi cal studies by Doctors Viola and Maltoni. On February 22nd NIOSH held a meeting of all interested parties in Cleveland, Ohio to review the situation. On March 1, the MCA sponsored a meeting on PVC decomposition products In Washington, D. C. Spokesmen for 12 firms ac knowledged that a problem existed and expressed their interest in a PVC decomposition project. On March 11th NIOSH sent a standard^ for the manufacture of synthetic polymer from vinyl chloride to the Occupational Safety and Health Administration (0SHA) which principally rec ommended that any employee exposed to measurable amounts of vinyl chloride should be required to wear an airsupplied respirator. The concept of a threshold limit for vinyl chloride was rejected. NIOSH also announced it would conduct a study to evaluate the degree of pro tection afforded by different types of respirators using vinyl chloride as the test gas. On March 22nd NIOSH -6- iSvv CUSAROSS 00205 issued a recommendation for medical surveillance^ of workers exposed to vinyl chloride. On April 5th OSHA issued an emergency temporary health standard^ to become effective April 8th reducing the TLV for vinyl chloride from 500 ppm. to 50 ppm. ceiling at the same time proposing a permanent standard that would not allow workers without protective equipment to contact vinyl chloride in any measurable concentration. Both standards cover workers involved in the manufacturing of vinyl chloride and its conversion into polyvinyl chloride. By law the temporary standard can remain in effect up to 6 months while a permanent standard is being formulated; however, the DOL plans to expedite the procedure to a period of 2 to 3 months. Assistant Secretary of Labor, John Stender said "the emergency standard will serve to protect workers from the grave danger we know exists." Further Stender indicated that his field people would be gin checking work practices in the entire vinyl industry almost immediately. Senator Henry Jackson said that the emergency standard "leaves too much to chance" and on April 9th told a United Rubber Workers group that legis lative moves will be considered if workers continue to be used for "experiments" in the name of occupational safety and health. Further he stated that any standard dealing with vinyl chloride should "err on the side of safety." Both B. F. Goodrich and Goodyear announced they had re duced vinyl chloride levels to below the 50 ppm. before the publication of the emergency standard and that they were providing protective equipment and clothing to em ployees. Dow said it has used the 50 ppm. standard for 15 years in its U. S. plants. A national surveillance registry^ for cases of angiosarcoma was also established by NI0SH and the U. S. Center for Disease Control (C.D.C.) in Atlanta. Physicians who have patients under their care with a diagnosis of angiosarcoma of the liver, or who have encountered such cases in their practice over the past 10 years, are urged to report them to CDC. As of early April, 1974 NIOSH reported 10 angio sarcomas attributed to vinyl chloride exposure. Of the total 7 cancers were discovered at the Goodrich plant in Kentucky, 1 at Union Carbide in South Charleston, West Virginia and 2 at a Goodyear plant in Niagara Falls, New York. In addition, 1 case has been discovered in Great Britian and several possible cases were reported in Germany. None of the reported cases in the U. S. were exposed less than 10 years in various phases of the vinyl chloride polymerization process. The Society of the Plastics Industry (SPI) met repeatedly with the Food and Drug Administration (FDA) officials early in 1974 to review the VCM situation. Based on the - 7- CUSAROSS 00206 experimental evidence the FDA concluded on March, 1974 that VCM is a carcinogen. An interim food additive regu lation was proposed and a suitable toxicological protocol was requested. The need for a literature survey had been previously discussed as well as toxicological studies to determine whether VCM is in fact a carcinogen for the rat when the route of exposure is via the diet. Toxi cology protocols for 90 day feeding studies were submitted by Food and Drug Research Laboratories, Inc. to SPI on February 12th to satisfy the food additive regulation. On April 16th an SPI Vinyl Chloride and Polyvinyl Chloride Producers Ad Hoc Committee met in Washington for the pur pose of considering the industrywide problems associated with the emergency temporary standard set by OSHA. Working committees were set up to gather data regarding levels of exposure in VCM and PVC plants as well as VCM residual levels in various polymer products shipped by the poly merization plants. In addition, a working group is also investigating the nature of any VCM problem that might exist in the plants of vinyl processors; if any problem should be found to exist in such plants, an attempt will be made to isolate the sites within the plants that might require special attention. Still further, another working group is investigating the economic impact if the standard should be significantly lowered to a level where poly merization could no longer remain in production, or if permanent standards should be set at a "no detectable" or 1 ppm. monomer level in air, using methods sensitive to 1 ppm. On April 22nd a meeting was held between SPI representa tives and OSHA to explain SPl's Intended participation. The SPI reported that OSHA is anxious to propose a perman ent standard that strikes a fair balance between the need to protect workers in PVC plants without making it economi cally impossible for the industry to continue. OSHA advised that, in the absence of any data on which to fix a "safe working level" and in the light of the MCA-sponsored data casting doubt on the safety of the 50 ppm. emergency standard, OSHA will propose a 1 ppm. peak exposure limit combined with a 40 ppm.-hour limit per week. It is now anticipated that a proposal will be in the Federal Registry this May. The Environmental Protection Agency (EPA) has also formed an internal task force to look into the effects of not only thehealth risks associated with the manufacturing of vinyl chloride but also possible environmental risks associated with the distribution and disposal of VCM and PVC. The task force plans to meet with environmental -8- CUSAROSS 00207 and consumer groups and the chemical industry to discuss its mission and exchange information. It is also working with OSHA, NIOSH, the Consumer Product Safety Commission and the Department of Commerce. The EPA currently regis ters 23 pesticide aerosols using vinyl chloride as a propellent and on April 24th recalled all pesticides, con taining vinyl chloride. In addition, Dr. D. Wesley CTLayton, EPA, Office of Research & Development, stated that he be lieved it was possible to establish a safe level for car cinogens. One EPA official noted that monitoring of water near vinyl chloride plants revealed between 2 and 3 ppm. vinyl chloride in water samples but evidently it survives in water for about 2 hours only. METHYL BUTYL KETONE In mid-August 1973, a worker in the printing department of the Columbus Coated Fabrics Plant, Borden Chemical Division, Inc., Ohio was seen on the neurosurgery service of the Ohio State University Hospital complaining of having been weak since May. Diagnostic studies confirmed acute peripheral neuropathy. Suspecting that a toxic agent might be responsible, Ohio State health officials performed electromyograms (EMG) on 1156 employees. Those with ab normal EMG's were given a neurologic examination. Tests revealed that 45 workers were severely afflicted and others to a lesser extent. Investigation showed that 35 of the 45 employees worked in the print department where a mix ture of methyl ethyl ketone (MEK) and methyl butyl ketone (MBK) was used in large quantities as a solvent. MBK was first used in August 1972 and since no other changes in materials had occurred in recent years, MBK was implicated as the toxic agent. The printing department was closed for one month in early September 1973 while MBK was removed from production materials and improved ventilation and work practices were instituted. Among the remedial measures are the wearing of respirators, rotation of workers required to wear res pirators, company-provided protective clothing and pro visions for eating meals away from work areas. A total of 700 members of the 950 employees in the bargaining unit represented by the Textile Workers Union's Local 487 were off work, some for as long as two months and the Ohio State Industrial Commission ordered a hearing to determine whether the plant should be closed. Following a series of meetings in Washington, D.C. with federal mediators and representatives of OSHA and NIOSH, a union-management agreement was reached to abate the hazard and NIOSH was assigned to coordinate the new safety program. Since the -9- CUSAROSS 00208 department's reopening in October 1973, no new cases of peripheral neuropathy have been discovered; however, on February 11th the union again went on strike ostensively over safety and health issues, claiming that at least 10 workers were still seriously affected by peripheral neuro pathy. Mediated negotiations in Washington, D.C. began again on February 25th. Borden Company representatives said that excessive union demands rather than health hazards at the plant might force its closing. The issue remains unresolved. While NIOSH investigated the use of MBK in other areas of the country, Eastman Chemical Products, Inc. a manufacturer of MBK. instituted studies involving exposure of MBK, MEK and methyl isobutyl ketone (MIBK) of dogs, monkeys, rats and guinea pigs.^ Inhalation concentrations ranged from 1300 to 2000 ppm. for 6 hours a day, 5 days a week during a four-month period. Although results on the dogs and monkeys were inconclusive, all 6 rats showed changes characteristic of peripheral neuropathy. Exposures to MEK and MIBK did not produce conclusive results. Guinea pigs were treated with skin application of MBK during a 4 month period. Eastman Chemicals Issued a letter on March 1, 1974 to its 2000 customers outlining the results of the study and recommending protective measures. RETAIL MEAT WRAPPERS In response to requests for health hazard evaluations of retail meat wrapping employees in and around Seattle, Washington, NIOSH conducted a limited study8 and concluded that the findings were generally applicable to all retail meat wrapping operations using PVC packaging films. It was determined that air contaminants generated by the thermal cutting of PVC packaging films in conjunction with the wrapping of meat are potentially toxic to some meat wrapping employees. The study primarily consisted of a literature review and examination of workers and work places. Evi dence suggested that a sizeable percentage of meat wrappers suffer from upper and lower respiratory tract symptoms. An attempt was made to Identify and quantitate air con taminants. Of the many additives, HC1 and a plasticizer, di-2-ethyl hexyl adapate, were the predominant contami nants. Recommendations were made regarding lower cutting temperatures, improved ventilation and medical surveillance. Other similar studies around the country have been con ducted and further investigation of affected workers is proposed. ,. \ \ \ -10- CUSAROSS 00209 ACROOSTEOLYSIS Occupational Acroosteolysis^ is confined solely to workers engaged in the production of PVC from VCM and is characterized by bony defects of the extremities and Ray naud's phenomenon. The disease was first noted in 1963. In 1971 Dinman et al reported 25 definitive cases with an additional 16 "possibles" after an extensive survey spon sored by the MCA of 5011 workers in 32 U. S. plants. With one exception all workers with the disease were production employees who either were or had been reactor cleaners, an incidence in this group of 3 percent. The period of exposure to vinyl chloride polymerization before the onset of symptoms was variable, as short as one month or as long as 3 years. The disease is diagnosed by the characteristic x-ray findings, generally limited to the hands, forearms and sacroiliac joints. There is no specific treatment except removal from exposure which usually slows or stops its progression. Improvement in the bony defects can occur and some workers have been returned to reactor cleaning. Prevention consists of reducing exposures by protective clothing, discontinuing the use of chip hammers, and engi neering controls, including solvent and steam cleaning which^ obviate the necessity of workers entering the reactors. MINAMATA'S DISEASE Between 1953 and 1960 methyl mercury in the effluent of a vinyl chloride plant poisoned 121 persons and killed 43 persons in Minamata, Japan. In addition, congenital de fects were found in 23 babies whose mothers were exposed during pregnancy. The methyl mercury primarily accumu lated in shellfish which were eaten by the local populace, birds and fish. No new cases of this disease have been reported since 1961. In 1971 Yogamuchi^ et al describes the recovery of methyl mercury compound from the sludge pit of a caustic soda factory in which only metallic mercury had been used in the electrolysis of sodium chloride. In this industrial situation the reaction occurred mainly in a sedimentation pit where a precipitate of calcium carbide is added to neutralize water from the electrolysis plant. Additionally trace amounts of methyl mercury have been produced experi mentally in the reaction of inorganic mercury with amorphous carbon, the material of which electrodes in the electrolysis plant are fabricated. The EPA has published a national emission standard that limits atmospheric emissions of mercury to less than 2300 grams during a 24-hour period. -11- CUSAROSS 00210 McGill et al found no evidence of dangerous absorption of mercury in workers in one chlor-alkali plant study. Air levels over a period of 6 years varied between 0.08 and 0.13 mg./m^ of Hg. as measured by a mercury vapor meter. Smith et al in a study of 21 chlor-alkali plants in the U. S. & Canada reported a positive correlation between exposure levels ranging from less than 0.01 mg./m^ of Hg. to 0.27 mg./m^ of Hg. and neurological Involvement (tremor, shyness, nervousness), loss of weight and loss of appetite. The demonstration by Smith of toxicity at levels below 0.1 mg.of Hg. and the,occurrence of toxicity between 0.005 and 0.06 mg. /mJ of Hg. reported by others resulted in the proposed NIOSH environmental standard of 0.05 mg./m^ of Hg. for protecting the health of exposed workers. The maximum allowable concentration for metallic mercury in the USSR which was established 30 years ago is 0.01 mg./m^. * -12- CUSAROSS 00211 \ \+t V- \ CUSAROSS 00212 VINYL CHLORIDE RESEARCH A paper by Professor P. C. Viola ^March 1970 Medicina del Lavaro, Vol. 61, No. 3, pp. 174-179) confirmed the toxic effect of vinyl chloride in producing degeneration of bone and connective tissue with histopathological changes similar to those observed in human acroosteolysis. Of the twenty-five rats which were subjected to very high con centrations of vinyl chloride at 30,000 ppm. for one year, six showed skeletal changes. Thirteen rats died from cardiorespiratory complications and 2 from hemoperitoneum. On the basis of this study he recommended that manufacturing plants polymerizing vinyl chloride should reduce the TLV and encourage automatic cleaning of autoclaves. In May, 19 70 Professor Viola presented a paper^at the International Cancer Congress in Houston which described a carcinogenic effect of vinyl chloride. The experimental conditions which produced the following changes were identical to those described in the first paper but in tills paper he states that 65% of the animals developed tumors of the skin, mostly epidermoid carcinoma, and 26% of these showed tumors of the respiratory tract exclusively localfzed in the lungs and morphologically appearing as an adenocarcinoma. Very few animals developed bone tumors, localized in the metaphyseal region. No liver cancers were described. In September 1970 an MCA Committee discussed Professor Viola's findings and determined that further research with lower concentrations of vinyl chloride should be done. Currently this program is being done by Industrial Bio test Laboratories in Chicago and is financially supported in the amount of $180,000 by contributions from 20 manu facturers of VCM and/or PVC. New participants, including Gulf are now being added to the program to help sponsor additional studies totalling $80,000. Initial contributions are $24.38 per million pounds of annual VCM plus PVC pro duction capabilities. It is anticipated that an additional $500,000 may be involved over the next 3 years. In a pre liminary report announced by Bio-Test on April 16th, mice exposed for seven months, seven hours a day, five days a week., to 2500 ppm. , 200 ppm. , and 50 ppm. were showing liver angiosarcomas at all levels while none were reported in the exposed rats and hamsters. Another MCA proposal to study the metabolic processes by which vinyl chloride reacts with biological systems has been prepared by the Dow Chemical Company and endorsed by the Technical Task Group of the MCA. In a related proposal Dow has also offered to conduct a small teratology -13- , - CUSAROSS 00213 study* These requests will entail a commitment of $80,000 from the supporting companies (metabolic studies $50,000, teratology studies $20,000, contingency studies $10,000.) Tabershaw-Cooper Associates were also contracted by the MCA to conduct a mortality study of workers engaged in VCM and PVC manufacture! at an estimated cost of $93,340. The objectives are (1) to compare the mortality of indi viduals who have worked in vinyl chloride plants with the general population (2) to compare mortality patterns within the population of vinyl chloride workers based upon ex posure, and (3) to compare the mortality of VC workers with other occupation groups. The final report has been delayed since the study is now being revised as previously described to review all suspicious cases of malignancy. A preliminary review of the data indicates that the overall mortality figures will be comparable to those of the general population. NIOSH is engaged in several vinyl chloride research efforts. Dr. Edward Fairchild is initiating a review of the avail able literature regarding the toxicological effects of PVC. NIOSH is undertaking a study of plants that have had PVC operations for 15 years or more and will review records of former workers in PVC plants. It is also evaluating res piratory protective equipment. As mentioned before NIOSH through CDC has also started a national surveillance reg istry for cases of angiosarcoma of the liver. A medical research program on angiosarcoma and related liver abnormalities is also being organized by the University of Louisville's Health Sciences Center and Cancer Center under a grant from the B. F. Goodrich Company. The first year of the program will cost an estimated $300,000. Eventually broader support may be sought. At the OSHA public hearing in Washington on February 15th Professor Cesare Maltoni, Instituto Di Oncologi , Bologna, Italy, reported on a series of experiments on the effect of exposure of rats, mice and hamsters to VCM at concen trations of 10,000; 6,000; 2,500; 500; 250; and 50 ppm. for varying periods of time. The results so far indicate that tumors have been observed in groups of animals ex posed to VC at concentrations as low as 250 ppm. No tumors have been observed at 50 ppm. He is now repeating this work with 300 animals at 50 ppm. Other organizations in the U. S. involved in vinyl chloride research include the University of North Carolina under the sponsorship of the Rubber Workers Union and the American Cancer Society. -14- CUSAROSS 00214 CUSAROSS UNION ATTITUDES IN THE U. S. When the announcement of the Goodrich cases was made, Louis Beliczky of the United Rubber Workers union said, "I look at this as the dropping of a bomb. It opens up the possi bility of a whole new occupational disease." Further he suspected a connection between the Goodrich and Borden p roblems. Dr. Irving Selekoff, Mt. Sinai School of Medicine, New York, N.Y., said there has been evidence of potentially serious disease among workers engaged in vinyl chloride manufacture for 25 years which has been incompletely appreciated and inadequately approached by medical scientists and regulatory authorities. Acute animal toxicity to vinyl chloride was reported as long ago as 1938 and important chronic toxicity was reported in 1961, Selekoff said. As far back as 1949 liver damage was found in 15 of 48 exposed workers in Russia and disease of the liver, skin and other organs was reported in the next 17 years from Rumania, Russia and France. Recent studies in Germany have shown that liver damage is far more common and far more serious than was expected. He recommends no further exposure by any route and emphasizes that no control should be considered too rigorous. Sheldon Samuels, Director, Health, Safety and Environmental Affairs of the AFL-CIO's Industrial Union Department (IUD), submitted a petition to OSHA on behalf of IUD and the United Rubber Workers for an emergency standard for vinyl chloride. Anthony Mazzocchi of OCAW also called for an emergency stan dard. "What we now know about the relation between cancer and vinyl chloride is only the tip of the iceberg because of the long latency period," Mazzocchi said. On publication of the temporary emergency standard Sheldon Samuels charged that the measure was ineffective and that the DOL had misinterpreted the Italian research; however, he did praise the proposed tougher permanent standard as "an important step forward." The committee on carcinogens of the IUD appealed to Congress for an immediate emergency appropriations bill to deal with the recently discovered hazards of vinyl chloride and related carcinogens. Peter Bommarito, President of the United Rubber Workers said, "we feel that very soon current animal studies will verify the real risk to humans at the 50 ppm. level" and urged that the standard be immediately expanded to include the NIOSH work procedures and medical surveillance recommenda tions. At a meeting on April 2nd in Mt. Sinai Hospital 12 union representatives agreed to fight the proposed 50 ppm. temporary standard. Stephen Wodka of OCAW announced s -15- CUSAROSS 00216 chat "OCAW would not support any position that allows any such standards to go forward. The Comm^tee said legal action might be taken if the 50 ppm. ...dard was promul gated. In addition the group called ro'r medical surveillance of all American workers exposed to vinyl chloride to begin immediately. Dr. Selekoff said that preliminary data in dicates that 5 percent of all deaths of vinyl chloride workers may result from liver cancer and that other oper able disorders apparently result from exposure to the sub stance. Beliczky said that the unions should have access to whatever exposure data corporations have but doubted if the information is valid and accused the employers of faulty sampling methods. rtl v / -16- CUSAROSS 00217 U. S. CONTACTS The following medical authorities on vinyl chloride were con tacted for information on the current situation: 1) Dr. Marcus Key, Director of NIOSH - NIOSH's recommenda tions for medical surveillance were reviewed and are included in this report. The research on respiratory protective devices will begin soon but the date of completion if uncertain. Dr. Edward's Committee on Toxicology now believes (April 1974) that there may be an acceptable level for carcinogens other than zero, but one which will likely be close to zero. Although there is no agreement as yet on the number of experimental animals necessary for statistical purposes, if Maltoni had conducted his studies on 500 to 800 animals instead of 64 and had no effect at 50 ppm. and a 1/50 safety factor allowed, then NIOSH might recommend a ppm. level for VCM (1/50 is a compromise between the FDA safety factor of 1/100 for natural carcinogens and the ACGIH safety factor of 1/10 for non-carcinogens). Undoubtedly this atti tude will change with consideration of the recent Bio-Test findings of tumors at 50 ppm. 2) Dr. Clark Cooper of Tabershaw and Cooper, Inc., a pri vate consulting firm. This firm had been conducting an MCA-sponso red mortality study of the vinyl chloride industry prior to the cancer incident. They are now reviewing the death certificate data for suspicious causes of death, e.g. carcinomatosis, hepatomas, liver deaths without autopsies, etc. They are also studying the death certificates of all workers who previously were diagnosed as having acroosteolysis. Dr. Cooper was gloomy about liver function tests for early detection of liver cancer but believes they must be done to establish baseline values and to demonstrate an awareness and interest in the problem. He would continue, however, to rely more on the medical history, asking questions regarding weight, appetite, fatigue, etc. He emphasized that the major emphasis must be to reduce exposures. 3) Dr. Maurice Johnson, Medical Director, B. F. Goodrich Company - Medical surveillance procedures were reviewed. All workers exposed to VCM or PVC are receiving an annual medical evaluation consisting of a medical his tory, physical examination, chest x-ray, urinalysis, CBC and SMA-12 profile. Liver function tests include a serum bilirubin, SGOT, SGPT, Alkaline phosphatase and a new test, GGTP (gamma glutamyl transpeptidase). Dr. Johnson emphasized that laboratory tests are rarely "17- CUSAROSS 00218 abnormal in angiosarcoma cases and that it is nec essary to quiz for symptoms; however, one of the Good rich cases had a slight elevation of LDH which led to a positive biopsy. Two of the Goodrich cases are living and blood serum studies for antigen activity are being conducted by the National Cancer Institute. All Goodrich workers exposed to VCM now receive a single PA hand x-ray annually. The frequency was initially every 6 months and may be extended to a biennial program since no cases have been found for 2 years. A medical history and physical examination have not been done in the past on this group but will be done in the future as discussed above. Some of the original cases of acroosteolysis which have shown considerable x-ray recovery have been returned to VCM work. Dr. Carl Dernehl, Associate Medical Director, Union Carbide - (Contacted by Dr. W. McClellan) - He re ported one angiosarcoma in a Union Carbide Employee and 9 total U. S. cases and 1 U.K. case as of March 20, 1974. All cases were in workers around the polymeri zation process who were exposed between 10 and 22 years. He believes there is a threshold dose between 10 and 50 ppm. There were no consistent symptoms or signs and only one of the cases had a history of hepa titis. Pathological study confirmed angiosarcoma and revealed a diffuse liver fibrosis. Union Carbide was advised by the FDA that vinyl chloride will be con sidered a carcinogen and proposed a limit of 50 ppb in f oo dwrap . 5) Dr. Thomas Milby, the Hine Laboratories, Inc., San Francisco, California - He confirmed that their laboratory would be able to ship containers to Taiwan for the collection of blood and urine samples to be analyzed in California for lead and mercury, respec tively. The cost for these analyses will be $10 each for blood and/or urine leads and $12 each for urine mercury. A discount of 20% will be given if the number of samples in any category exceeds 10. They would also bill for shipping charges to Taiwan. 6) Dr. Ralph Erickson, Chief of Pathology, Western Penn sylvania Hospital - We discussed the new gamma glutamyl transpeptidase (GGT) test of liver function. This test is nearly specific for liver and biliary tract disease causing intrahepatic obstruction and is particularly accurate for acute alcoholic hepatitis. Elevations, however, are sometimes seen following myocardial in farction. The hospital first offered this test in March 1974 at a cost of $8.00. -18- CUSAROSS 00219 TAIWAN CONTACTS 1) Dr. C. H. Yen, Director General, National Health Ad ministration (NHA) - A meeting with Dr. Yen was ar ranged to advise him of our Company's concern with respect to occupational health In general and to the vJnyl chloride problem in particular. He was fully aware of the current situation in the U. S., having recently visited with Dr. Marcus Key at NIOSH in Washington and reviewed vinyl chloride literature. Additionally both the Chinese and English edition newspapers in Taiwan have had front page articles describing the problem. He was pleased that the CGPC was actively engaged in an early preventive effort and offered his help should it become necessary. He is vitally concerned about the lack of occupational health services on the island and discussed a proposal now under consideration to seek government, univer sity and private support for an independent occupa tional health consulting service to be established in the National Taiwan University. This program would ultimately provide occupational medicine and industrial hygiene consultation and a full range of laboratory services for both government and industry. A major roadblock to date has been the reluctance of the Ministry of the Interior to co-sign an agree ment with the NHA since they evidently wish to remain independent; however, they are expected to sign within two months. Philco is presently sponsoring the training of two industrial hygienists at the Uni versity of Washington in Seattle, both of whom will hopefully return to Taipei and initiate the program. At that point, or perhaps sooner, the Company can anticipate being asked along with other industry for on the island financial support for this effort. Dr. Yen is a Graduate of Peking National University and has devoted his professional life on the mainland and in Taiwan to public health. He served as Commissioner of Health for Taipei for many years prior to his pre sent appointment. He also held assignments for WHO in Geneva and Manila. 2) Dr. Cheh-Teh Loo, Director, Taiwan Veterans General Hospital - I met General Loo at his office in the Kohlberg Medical Research Laboratory which is adjacent to the Veterans General Hospital. The major purpose of the visit was to determine if the hospital could perform laboratory tests for CGPC. I was told by General Loo that this could be arranged and costs were generally discussed. *t V 'i? -19- CUSAROSS 00220 While the mission of the Veteran's General Hospital is to render diagnosis and definitive treatment to pa tents under the care of the Vocational Assistance Commission for Retired Servicemen (VACRS), private patients are accepted for both inpatient and out patient care. This 996 bed hospital is located in suburb of Taipei called Shipai. It is a modern facility with a staff made up of 220 doctors, 353 nurses, 153 nursing attendents and 181 technologists. The average cost per day for veteran patients is $NT 170 ($U.S- 4.49). All professional medical and surgical services are provided by the hospital. Clinical laboratory services are extensive considering that special investigation can be referred to the Kohlberg Research Laboratory, An SMA-12-60 auto analyzer is in use in the hospital. A Laboratory Department Price List gives the following price quotations for several of the tests of interest to us : a. Complete blood count (CBC) b . Erythrocyte Sedimentation Rate c . Serum bilirubin d . S GOT e . SGPT f . Alkaline phosphatase s$NT 33 ($U. . 0.87) $NT 15 ($U.S. 0.40) $NT 15 ($u.S. 0.40) $NT 30 ($u.s. 0.80) s$NT 30 ($U. . 0.80) $NT 30 ($u.s. 0. 80) General Loo indicated that an SMA-12 profile would cost approximately $U.S. 12.00. He offered to send techni cians to the plant at minimal additional expense to obtain the blood samples from the workers. He felt that this would assure that the specimens were col lected, labeled and eventually reported correctly. He further advised that the hospital did not do GGTP, lead or mercury analyses and suggested contacting the Navy Medical Research Unit (NAMRU-2) for advice on this. 3) Captain Raymond Watten, Commanding Officer, U. S. Navy Medical Research Unit (NAMRU-2) - Dr. Watten reviewed the mission of NAMRU and informed me that personnel were being immediately reduced from 250 to 200 be cause of a critical lack of research funds. Since he is retiring in two months he suggested I talk to other responsible persons in NAMRU to determine if they could offer laboratory support. He indicated a degree of optimism by saying that NAMRU might be able to analyse blood samples for the Company providing we either furnished or purchased the reagents. A tour of the laboratory which followed revealed an adequate capability for out laboratory needs. Fur ther discussions with NAMRU personnel (Commander Berg, Chief of Pathology and Captain Blackwell, Hematologist) -20- CUSAROSS 00221 and Dr. Palmer Beasley, Associate Professor, University of Washington, revealed that they would not be able to do the work because of the personnel cutback unless the Company was willing to hire a full-time technician, based in NAMRU for this purpose. They were advised that we would continue to seek other alternatives. Dr. Beasley is Board Certified in Internal Medicine and Preventive Medicine and is engaged in hepatitis re search in Taiwan. He is also vitally interested in establishing an occupational health capability on the island. The results of his research are of signifi cance to our industrial medical surveillance program. Hepatitis B antigen has been found in 15 to 20 per cent of persons of working age. Of these 10% have abnormal liver function tests, or about 2 percent of the total. This compares with the Philco experience of 3 percent positive liver function tests in their employees working with solvents. Since autopsies are not commonly done the incidence of primary hepatoma is unknown; however, it is either the first or second most common malignancy -nasopharyngeal cancer is the other - and one person stated that it comprised 20% of all reported malignancies in adult Chinese population. . 4. Dr. Herbert Northrup, Medical Director, Philco - Dr. Northrup has made several visits to Taiwan following an incident in 1972 in the Philco television plant near Taipei in which 5 women working with solvents died of acute liver disease and 19 women were ill. Following the incident 200 employees quit work and absenteeism ran about 500/day. The plant was sub sequently shut-down for several days. While it was never definitely established that the solvent was responsible for the deaths -- no autopsies were done-- and Philco strongly feels otherwise, the experience has cost Philco $2 million to date. There are now 2500 employees at the Philco plant. Philco does all of the preemployment and periodic (annual) physical examinations at the plant. Laboratory studies in cluding liver function are done at the suburban branch of the McKay Hospital which is adjacent to the plant. In addition an improved reporting system was established for all cases of suspicious illness. * ^ In the past. Dr. Northrup arranged for blood speci mens for workers in the Ford plant on the island to be sent to Dearborn, Michigan for blood analysis after poor experiences in the U. S. Navy Hospital in Taipei and in Japan. Recently the DOL has ordered Ford to renew this blood lead testing program. ^ -21- CUSAROSS 00222 5. Dr. Chen-Hui Lui, Professor, Department of Medicine, National Taiwan University - Dr. Lui is a hematologist and is currently Director of the Clinical Laboratory of the College of Medicine. I toured this laboratory to determine Its acceptability for conducting our biological tests. While Dr. Lui affirms their ah til tv to perform nearly all laboratory procedures, including heavy metal analyses, it is not up to the standard of the Veterans General Hospital in terms of techni cal personnel or equipment. There is no SMA-12-60 although one apprently has been on order for some time. A room with a spectrophotometer for testing heavy metals is cluttered with motorized equipment which undoubtedly would contaminate the samples. In my opinion the use of this laboratory at this time would be a poor alternative. Cost estimates were given later by Dr. Chen over the telephone: CBC (rbc, wbc, Hb., Ht.) $NT 100 ($U.S. 2.64); liver profile $NT 450 ($U.S. 11.87); blood lead $NT 200 ($U.S. 5.28); urine mercury $NT 200 ($U.S. 5.28). 6. Dr. George Hahn, Country Hospital, Taipei - Dr. Hahn is an internist, cardiologist, and former Director of the Country Hospital and Is well known to many of the Gulf families living in Taipei. Recently he has been con ducting management health and overseas medical exami nations and appears to be doing a very thorough workup. I toured the hospital and in particular reviewed the laboratory as a possible alternative for our use. The laboratory is small and under the direction of a technician trained at the National University of Taiwan. Since there is no pathologist in charge, the technician is under the general supervision of the medical staff. Most standard hospital labora tory tests can be done and those which cannot have in the past been sent to the National Taiwan University or to NAMRU. Laboratory tests are extremely cheap, a routine blood count costs $NT 50 ($U.S. 1.32) and a liver profile (bilirubin, SGOT, SGPT, alkaline phos phatase, CF, TT, TP) $NT 150-200 ($U. S. 3.96 - 5.28). I am concerned that the cost, as in Toufen, may re flect the quality of the work. Dr. Hahn feels the laboratory is reliable but occasionally sends specimens outside for recheck. -22- CUSAROSS 00223 OCCUPATIONAL HEALTH AGENCIES AND REGULATIONS IN TAIWAN The National Health Administration (NHA) is charged with responsibilities similar to the U. S. Public Health Ser vice and In the occupational health field it relates to 7 N r 0 S H, although their capabilities are severly limited by the lack of trained or experienced people. The NHA has Divisions of Public Health and Occupational Health both on national and provincial levels. They do respond to health problems in industry but seldom conduct regular inspections. The Ministry of Interior, Department of Labor (DOL) has responsibilities for occupational health corresponding to those of OSHA under the U. S. Department of Labor. The major functions are to promote occupational health and safety in Taiwan and to conduct inspections and enforce regulations. Inspections are principally conducted by the Provincial Industrial and Mining Inspectional Committee (PIMIC); the Taipei Municipal Inspectional Office which is concerned with public safety as well; and the Kaohsuing Industrial Export Processing Zone which has its own Industrial Health Clinic to take care of general health and preventive medicine in this area. The China Industrial Safety & Health Association is a private organization funded by industry, primarily to offer training programs for safety supervisors, environ mental pollution and boiler inspectors. It published a quarterly safety and health journal. The China Productivity Center is another private organization which provides training in industrial safety. The School of Public Health in the National University of Taiwan offers about 6 hours of occupational health in struction to medical students. There is also a two year graduate course leading to a Masters Degree in Public Health which has courses in occupational health including field trips. This school is being promoted as the future training and service center for occupational health and industrial hygiene activities on the island. Fundamental labor policies of the Republic of China can be traced to the Constitution of the Republic and include non-discriminatory freedom of employment; the right to work; freedom of association; a social insurance system; protection of women and children; and health protection. "The State, in order to improve national health, shall establish extensive services for sanitation and health -23- CUSAROSS 00224 protection, and a system of public medical services." The policy of promoting industrial hygiene and occupational health is consistent with the provisions of this Article. The following laws and regulations are concerned with occupational health and safety: Factory Law; Statute for the Enforcement of the Factory Law; Factory Inspection Law; Miner Field Law; Statute on Employee Welfare Funds; Statute on Labor Insurance; Regulation Governing Safety and Health Facilities in Factories; Provisional Standards Concerning Medical Facilities in Factories and Mines; Regulations governing hours of work for Boiler workers; Regulations on the Formation of Safety and Health Committees in Factories and Mines; Regulations on the Safety Control of Fireworks Factories; Regulations Governing Safety of Mines in the Taiwan District; Provincial Regulations on Base Wages; and the newly established Occupational Health and Safety Law. (April 1974). None of the above laws and regulations was available in English; however, they do establish standards similar to the U. S. OSHA regulations and in some cases are more restricting. The head of the company/factory is responsible for occupational health and safety and is subject to penalties, including prison sentence, for non-compliance. English translation of the new Taiwan OSHA will be necessary to evaluate the CGPC compliance situation. -24- CUSAROSS 00225 CHINA GULF PLASTICS CORPORATION China Plastics Corporation began operations in Toufen in 1966 for the purpose of producing PVC resin and fabricated products. In 1968 Gulf became part owner of the Company and the name was changed to China Gulf Plastics Corporation (CGPC). The Company has diversified and expanded opera tions and now produces over 25,000 metric tons of resin and fabricated products a year. There are presently three CGPC office locations and five manufacturing plants in Taiwan in which GCPC has a financial and operating interest. The main office in Taipei employs approximately 150 persons. Branch sales offices are loca ted in Taichung and Kaohsiung, principal cities in Taiwan, and employ an additional 50 persons. Manufacturing facili ties are as follows: TOUFEN FACTORY This is the original China Plastics Corporation factory and is located on the northern part of the island, approxi mately 1-1/2 hours by train 100 kilometers southwest of Taipei, and 70 kilometers from Taichung. Mr. Wilbur Shyeh is the General Factory Manager. The plant produces vinyl chloride monomer (VCM) from local sources of calcium car bide and salt as well as PVC resin, fabricated and related products, including sheet, film, leather, sponge leather, pipe and fittings, floor tile, flake and liquid caustic soda, hydrochloric acid, liquid chlorine and special products. There are currently 1200 factory employees, including 71 women, working 3 shifts of 8 hours daily, six days a week. Prior to April 1, 1974 all manufacturing employees worked 7 days, 8 hours daily, a week. The average age of the male factory workers was estimated to be 29 years and the average salary $NT 3600/month ($U.S. 95) per month. Turnover has been as high as 51% per annum but was 31% in 1973 and many workers quit after 2 to 3 years. There is a 40 day pro bationary period for new factory workers. The Company maintains dormitories on-site for about 250 staff and workers. Other benefits include a retirement plan (trans lated into English) with mandatory retirement at age 65 and voluntary retirement at age 60 or after 25 years of service (70 point system), a pension plan, two uniforms per year, holidays (17 days/year), medical services and inexpenisve haircuts. Employees contribute 1/3, $NT 50/month -25- CUSAROSS 00226 ($U.S. 1.32) and the Company 2/3, $NT 100/month ($U.S. 2.54) to a Labor Insurance Scheme which provides benefits in the event of child-birth, injury, disability, death and old age. Since 1956 inpatient hospitalization has been avail able free of charge to insured workers and free outpatient treatment in hospitals for employees, not families, was introduced in 1970. The Company also provides medical care for those families of employees who live on or near the factory, approximately 300 dependents. After one year of employment all workers are eligible for 7 days of per sonal leave and 40 days of sick leave per year with full pay. If an employee is ill more than 40 days the plant manager may grant 1/2 pay, but when the illness exceeds 6 months the worker is subject to discharge. Staff bene fits include 5 days personal leave and 2 weeks sick leave per year. All work injuries and illnesses for both groups are fully compensated. A Welfare Committee meets periodi cally with representatives of the worker's union. The factory is presently operating at about 50 percent capacity because of a lack of orders and consequently many workers were not doing their usual work but performing busy-work, e.g., trimming, maintenance, etc. Medical personnel include one full-time physician (Dr. L. F. Tang), one part-time physician and two full time nurses (Miss K. H. Chiu and Miss G. M. Fu). Dr. Tang completed medical school on mainland China and practices general medicine. Both nurses are Taiwan-trained. Dr. Tang's salary is slightly more than $NT 10,000/month ($U.S. 264) per month, the part-time doctor receives $NT 4,000/month ($U.S. 106) per month and the nurses make about $NT 3,000/ month ($U.S. 79) per month. The medical facility consists of 3 rooms -- an office and pharmacy combined and two treatment rooms. There are no physicians' offices, examining rooms or toilet facilities. Equipment is sparse and includes a single size E oxygen inhalator on a stand, a few medical instruments for wound treatment and suturing and a minimum of diagnostic equip ment. Many drugs are available including cold medicines, antihistimines, cough syrups, antibiotics, intravenous fluids, ointments, etc. Narcotics and disposable syringes are not available. Sterilization equipment is old and cumbersome to use. Clinic hours are from 7:30 A.M. to 7:00 P.M. There is no ambulance on-site and the available minibus has not been adapted to handle stretcher cases. Medical personnel are primarily engaged in the treatment of dependents, seeing about 30 to 35 patients daily. Em ployees are also seen for minor injuries and illness and -26- CUSAROSS 00227 referred to local medical facilities approved by the De partment of Labor for more serious problems. About 2 or 3 emergency cases a month are sent to the hospital by car or taxi. There are 5 medical and surgical hospitals within 15 to 30 minutes from the factory which are used for re ferral depending on the type of illness or injury. FirstaLd training of staff or workers is limited and given along with safety training. There are minimal first aid supplies around the plant. Laboratory studies are done in an out patient laboratory in town which was visited and is com pletely inadequate and unreliable. An x-ray facility at a local surgical hospital utilizes modern Japanese equip ment and is acceptable for ordinary x-ray procedures. Medical programs include BCG for dependent children (be tween 5 and 10 new cases of tuberculosis are seen annually in the workers), preemployment examinations (height, weight, blood pressure, vision, heart and lung check, serology and chest x-ray) at a Labor Insurance Bureau approved facility; annual periodic exams (height, weight, blood pressure and chest x-rays for employees over 40 and biennial for em ployees under 40) also carried out at government approved facilities; and the recently instituted special exams of workers exposed to VCM (hand x-rays and liver tests) sol vents, mercury and stabilizer dusts (urinalyses and blood counts every three months with liver function tests if positive). The cost of a blood count (rbc, wbc, hemo- t globin, reticulocytes)and urinalysis (protein, bilirubin, urobilinogen, coproporphyrin) is $NT 80 per person ($U.S. 2.31). PA and oblique hand x-rays cost $NT 40 ($U.S. 6.33). The number of participants currently re ceiving special exams of this type are as follows: Reactor workers Solvent workers Mercury workers Stabilizer workers 8 69 26 51 Results to date indicate about 25% abnormal urinalyses, primarily positive for urobilinogen and coproporphyrin, fairly equally distributed between the groups; however, in my opinion these results are invalid because of the unreli able laboratory facility. This is also true for the 8 reactor workers who received liver function tests on April 2nd (bilirubin, SGOT, SGPT, alkaline phosphatase, cephalin flocculation, and Takatas. All 8 workers had a positive cephalin flocculation test and 7 of the 8 had a positive Takatas test. All other tests for liver functions were normal. These studies also are meaningless in view of the laboratory involved. All hand x-rays on the 8 reactor workers reviewed in the U. S. were normal. No biological lead or mercury analyses have been done to date. -2 7- CUSAROSS 00228 Absenteeism at the Toufen factory is alleged not to be a significant problem. The majority of absences are evidently for military service -- one day every 3 months and/or 1 month periodically -- and there are more absences during rice harvest time in the North in July and October. Since records of sickness absences were not available the fol lowing review of sick leaves of workers in hazardous areas for 1973 was requested: Record of Sick Leaves Requested by Workers Working in Hazardous Areas - 1973 No. of Total Sick Leave Workers in 19 73________ % 1. Mercury Chlor-Alkali 1) Elect rolyse r 2) HC1 & Chlorine 41 6 14.6 2. Polymer Polymerization 1) Raw mate rial 2) Cleaning 3) Discharging PVC 16 6 37.5 3. Dust Extrusion, Film, Leather, Formu lation Masterbatch 23 1 4. 3 *- 4. Solvent Leather - Coating surface treatment Film/Sheeting Printing & 96 30 31 - 3 5. Dopfume Film/Sheeting Mixer, Bambuary Mixing Ro11, Calender 82 11 13.4 TOTALS 258 54 TOTAL NUMBER OF WORKERS IN TOUFEN PLANT - 1060 TOTAL SICK LEAVE OF WORKERS IN HAZARDOUS AREA 7-517 TOTAL NUMBER IN TOUFEN PLANT ' 20.9 While the data seem to indicate a potential problem in the poly mer and solvent working areas the number of polymer workers may be too few to he significant. Solvent workers, however, are known frequently to complain of headaches and these -28- CUSAROSS 00229 figures may reflect valid sickness absences. Obviously, a uniform system of absence records due to illness needs to be instituted to substantiate these statistics. Since 1970 employees have been advised orally of symptoms associated with solvent, lead and mercury exposures and asked to report any suspicious illness. The statement was made that the Company does not want to hide these potential problems from its employees. No workers have died while actively employed since the fac tory began operations in 1966 and less than 10 have retired. While death certificates in the country do list a cause of death and are signed by a physician, autopsies are very un common. Additionally, annuitants are paid through an out side trust fund and consequently the trust fund, not the Company, would normally receive a copy of the death certifi cate. The Company would receive copies of death certifi cates of employees who die while actively employed but would have no way of obtaining death certificates on em ployees who die after leaving the company for reasons other than retirement. A review of plant operations at the Toufen Factory confirms the engineering findings that there are considerable ex posures to solvents, stabilizer dusts, mercury, DOP fume, VCM and PVC resin. There are also potential exposures to a large variety of chemicals including printing inks, chromic acid and hydrogen cyanide. In addition, present work practices may enhance the exposures. Long hours (formerly 56/week and now 48/week), lack of convenient sanitary fa cilities (lockers, washbasins, showers), eating on the job and no uniform change or laundering policy all contribute to the possibility of overexposures. The industrial hygiene engineering survey conducted by Dr. Robert Cheng confirms my observations that the following areas or operation are of greatest concern: 1. Leather room - three calenders and a forming oven; exposures to solvents, primarily MEK, DOP, inks, PVC, stabilizer dusts. Ventilation around the troughs is inadequate; men eat on the job; washing facilities not immediately available; housekeeping good, 2. Film room - three calenders; exposures to DOP, PVC and stabilizer dusts; ventilation over calenders probably adequate; housekeeping good. -29- CUSAROSS 00230 3. Printing shop - two printing machines; exposures to MEK, MIBK, toluene, inks; ventilation inadequate; men eat on the job; sanitary facilities not immedi ately available; housekeeping good. 4. Scrub reclaiming room - exposure to DOP; men working between exposure and hood; housekeeping good. 5. Film and leather room combined ~ two calenders and two forming ovens; exposures and work practices as in No. 1 and No. 2 above; housekeeping good. 6. Extruder plant - extruders, bagging operations, gas powered fork lifts, exposures to pigments, PVC, stabilizer dusts and carbon monoxide; ventilation inadequate at bagging operation; men eat on the job; sanitary facilities not immediately available; workers with dusts wear masks and are required to have frequent haircuts and shampoos; many workers wear cotton gloves to prevent burns; housekeeping fair. 7. Machine shop - welding; ventilation probably adequate; protective equipment available; housekeeping fair. 8. Laboratory - usual laboratory procedures; small ex truder; approximately 30 employees; one hood avail able; one bottle of MBK seen; Coleman mercury analyzer equipment; housekeeping good. 9. Master batch room - make color chips; exposures to color dyes, stabilizer dusts; men work between ex posure and ventilation equipment; protective masks and cloth gloves normally worn; housekeeping good. 10. Catalyst building - has an enclosed room under negative pressure for handling toxic substances; exposures to sulfuric acid, chromic acid, sodium cyanide, hydrogen cyanide; well ventilated plus scrubber; at one time had a bird in room to detect toxic levels of gases; protection equipment available including gas masks and clothing; housekeeping good. 11. Dry chlorine unit - not operating on visit; make HC1 and send to TVCM plant; exposures to noise, ear plugs required;housekeeping good. 12. Chlo r-alkali plant - 31 mercury cells plus 5 under construction; each cell opened for 5 hours and cleaned once monthly; exposure principally to mer cury which is purchased in 70 pound metal containers from U. S. and Mexico; 5 men on 3 shifts after new -30- CUSAROSS 00231 cells completed; ventilation inadequate, particularly in view of new installation; sanitary facilities available but inadequate; (men are supposedly re quired to shower daily but a single shower beneath cells is nearly inaccessible) workers mainly stand around inside perimeter of building and upwind to reduce exposures; housekeeping fair (some mercury was observed on the cement floor beneath the cells); vacuum equipment is available and working to clean mercury spills. 13- Soda flake operation - beneath mercury cells; exposure to soda flake and mercury; ventilation and lighting inadequate; protective equipment available. 14- Drying plant - drying and bagging operations; bags are heat-sealed; exposure to PVC resin; ventilation inadequate; men wear masks. 15. Autoclave building - 12 reactors; exposures to VCM and PVC flake (during normal operations the cleaning inside the reactor takes 3 men about 1 hour, 4 re actors per shift); ventilation inadequate; shorts only normally worn to clean reactors (no gloves or shoes); no respiratory protective equipment. 16. Pilot plant - one small reactor for polymerization; when operating one reactor cleaner/shift required; exposures to VCM, PVC, ethyl acetate, maleic anhy dride, lauryl peroxide; ventilation by two elevated fans inadequate; sanitary facilities not immediately available; housekeeping fair. 17. VCM unit - carbide process; exposure to VCM with leaks and when lab samples are taken or when residue is discharged from distillation; ventilation normally good since unit is outdoors; protective equipment available; housekeeping good. 18. Asbestos from Taiwan was used in the manufacture of floor tile in the Toufen factory for 2 years until 2 years ago. Normally asbestos is not used as an insulation material in this factory. 19. All factory water is supplied from deep wells on-site and is treated chemically and by aeration. It is checked periodically for chemical content but not for bacteria. The Chinese, however, customarily boil all water before using for food or drink. Sewage is discharged directly into the Chungkang River 4 kilometers from the factory without treatment. -31- CUSAROSS 00232 Industrial effluent treatment facilities are presently under consideration. Industrial waste is discharged directly Into the river except for the carbide slurry which is neutralized in a holding pond on-site. I was told that government regulations now requiring a limit of 200 grams/metric ton of NaOH will decrease to 100 grams/metric ton in 1975 and probably lower thereafter. About.$NT 300,000 ($U.S. 7,916) is paid yearly to local farmers to compensate for crop damage. -32- CUSAROSS 00233 TAOYUAN PLANT The Taoyuan Plant of CGPC is located in the countryside about 8 kilometers from the town of Taoyuan and 30 kilo meters from Taipei. Mr. P. C. Parng is plant manager. This plant which is a satellite of the Toufen Plant is two years old but was purchased by CGPC in May 1973. Per sonnel records are kept at Toufen. There are 93 employees (13 staff including 2 women and 80 workers) on 3 shifts of 8 hours each, 7 days weekly (6 days weekly beginning April 1). Turnover is said to be high. A new dormitory is under construction which will accomodate more workers than the 16 presently living in the old unit. Salaries average $NT 60 to $NT 80 per day ($U.S. 1.50-2.00) and benefits are similar to those previously described for the Toufen employees. All workers are issued 2 complete uniforms and one jacket per year and are responsible for laundering. Work practices are similar to the Toufen Factory and it is customary for the men to eat on the job. The plant fabricates PVC film and sheet from PVC resin. Plasticizers (DOP), fillers (calcium carbonate), and stabilizers (lead, cadmium and barium stearate) are added to PVC resin in a high speed mixer and then gravity fed into a Bambuary mixer where color pigments (red, yellow, green, etc.) are added. The material then goes through a mixing roll (140C.) to a strainer (PVC string), then to a calender (170C.) and finally to cooling and winding drums. Finished products are shipped by outside trucking firms. Both calenders are usually operating but because of the lack of orders only one was in use during my visit. A laminating machine in the room was also not operating. Normally 6 men are required on the calender line per shift. In addition, each shift has a foreman, boiler man and electrician on duty. Maintenance is carried out by one man on the day shift only while workers are also responsible for cleaning their machines. There is a small one-man laboratory, a small repair shop where welding is done and the boilers are located in a separate building. Workers who add materials to the mixers are primarily ex posed to PVC resin and stabilizer dusts and wear cloth masks. Ventilation equipment is available near the point of dust generation but an exhaust had been detached. Both mixing rolls and calenders have large overhead exhausts but DOP was easily detectable close to the calender which was operating. Noise was not excessive with one line operating; however, boiler room workers may be exposed to excessive noise at times. Lighting was barely adequate -33- CUSAROSS 00234 with all lights on. Housekeeping was very good. Sanitary facilities are immediately available near the operations area. A shower is supposedly available in the plant but was not observed. All. water for plant and personal use comes from a 300 foot well on-site. The water is filtered, goes through an ion exchanger and is aerated. Samples are tested every three months for minerals including iron and cadmium but no bacteria checks are made. Waste effluent is not treated and sewage goes by open trench to a nearby rice paddy. Medical services are not available on-site and the plant minibus has not been adapted for stretchers. First aid kits are kept in the plant but are inadequately stocked. Supervisors receive a minimum of first aid training along with safety instruction. Accidents are few and generally are finger injuries in calender workers. Emergencies are sent by car or ambulance to a small hospital about 5 minutes from the plant or to St. Paul's Hospital in Taoyuan about 30 minutes away. Both facilities have been approved by the DOL to handle industrial cases. All workers have preemployment examinations at DOL-approved facilities which include height, weight, blood pressure, chest and abdominal checks, serology, and chest fluoroscopy. Major reasons for rejection include a positive serology, tuberculosis and color blindness. Annual checks are simi lar and are also done outside the plant in government ap proved facilities except for a chest x-ray survey conducted by the government on-site. -34- CUSAROSS 00235 KUEISHAN PLANT This newly acquired plant of CGPC is located in an indus trial complex near Taoyuan. Mr. Huang Pei Chla is plant manager. The plant is 6 years old and was purchased by CGPC in March, 1974. It is also called Waterfall Plastics Fabrication Ltd. There are 175 employees (17 staff, 140 female workers, 18 male workers) on one shift, 6 days weekly or 13 days every 2 weeks. The women are quite young - minimum age of hiring without a permit is 16 and with a permit is 14 -and turnover is very high. Women cannot work in a factory after 10 P.M. Quitting seasons are generally after the lunar New Year when bonuses are given and after general increases if inadequate. Nearly 80% of the women live in nearby Company dormitories. A newly hired female worker makes about $NT 48/day ($U.S. 1.27) plus $NT 12/day ($U.S. 0.32) meal allowance. Experienced women get about $NT 60/day ($U.S. 1.58). Benefits are as previously de scribed except that the women receive 3 uniform issues/year (2 shirts and skirts and 1 jacket and pants). A laundry is available near the dormitories for their use. This plant fabricates PVC film, sheet and leather into a wide variety of finished products including raincoats, shower curtains, mattress covers, shoe files and bags, steering wheel covers, pillow protectors, travel suit bags, curtains, purses, tote bags, table mats and air mattresses. Operations consist of cutting, sewing, high frequency welding, folding and packaging of the plastic materials and products. Women normally perform all of these activi ties except for cutting. High frequency welding is with a copper electrode and produces no discernable fume. The only odor in the plant is from the PVC plastic itself. There is no noise problem and lighting seems adequate. There is no air-conditioning in the factory and the main work area under a corrugated roof probably is very hot in the summer season. Preeraployment and periodic examinations are similar to those previously described and are done in the local hospi tals and clinics. A small first aid unit is available in the industrial complex with a full-time physician. Dr. Chang, who normally handles very minor cases only and sends the rest to the local hospitals including Poai Hospital in Taoyuan. A minibus is used to transport patients and an ambulance may be called from St. Paul's Hospital although this has not been necessary to date. No one has received first aid training. -35- CUSAROSS 00236 TAIWAN VCM INDUSTRIAL CORPORATION KAOHSI UNO PLANT This plant which is located in the city of Kaohsiung was built by Taiwan Alkali Corporation and began operation in April 1971. CGPC now owns a minority interest but main tains management control. The manager is Mr. Chow Tsung Lin. The plant Sits at the periphery of the large Taiwan Alkali Corporation facility and near a large Formosa Plastics factory. There are presently 156 employees (5 female) working 3 shifts, 8 hours daily, seven days a week. In the past there has been a tendency to rotate jobs. Employment will increase by 9 or 10 persons when the new oxy unit now under construction is on stream. About 1/2 of the personnel are Taiwan Alkali employees and there is evidently some un certainty about their employment status since the CGPC Intervention. This also applies to the benefit program. There is a dormitory nearby for some of the workers. Uni forms have not been issued yet but one is ready. Most workers carry a lunch box and eat on the job although there is a private cafeteria across the street. Each worker has a small locker and shower facilities are avail able near the plant entrance but look little used and were not all functioning properly. Production was 120 metric tons VCM/day although the plant was designed for 180 metric tons/day. The VCM process is simply shown as follows: Cl2 (T. Alkali) C2Ha (CPC Refinery) Ethylene dichloride VCM <------------ Sold to ^------Formosa Plastics & Other plants HC1 <------------ + c2h4 + o2 V pyrolysis <:-- cracking (Oxy . unit) Ethylene dichloride vy A < The process is enclosed and outdoors. Chlorine, ethylene dichloride and vinyl chloride are commonly smelled out in the plant. Vinyl chloride exposures occur primarily with -36- CUSAROSS 00237 leaks and when sampling for laboratory analyses- Freon gas is used as a refrigerant. The oxy unit is under construction and should be on stream this July. The plant is run from a large enclosed control room. A product pipeline runs from the plant to the dock (Kaohsiung is the second largest seaport in Taiwan). The compressor for the refrigerant was noisy. Housekeeping was fairly good. The plant does not have its relies on the Taiwan Alkali a part-time doctor on-site. will be able to continue to own medical facility but still first aid unit which now has It is uncertain whether they use this as a medical backup. -37- at*;- CUSAROSS 00238 TAIWAN VCM INDUSTRIAL CORPORATION TOUFEN PLANT This plant which also manufactures VCM is across the road from the main CGPC Factory near Toufen. The plant is new and began operations in April, 1974. Production will ap proximate 5,000 metric tons/month. It is adjacent to a China Petroleum Company (CPC) ethylene plant from which ethylene is piped directly to TVCM. Since the plant manager, Mr. C. C. Young, was not present on the day of my visit, I was escorted through the plant by Mr. Wilbur Shyeh and Mr. T. H. Wei, Superintendent of Op era tio ns. There are 74 employees (19 staff and office, 30 operators, 18 maintenance, 7 laboratory) working 3 shifts, 8 hours daily and seven days a week. Many of the workers have been assigned from the CGPC Toufen plant. Benefits presumably will be similar to those offered the Toufen factory workers. The Toufen dormitory is also available to these workers. Each man has a locker and uniforms. Wash facilities are available but there are no showers. The process is similar to that described for the TVCM plant in Kaoshiung. During start-up several leaks were identified and the odor of ethylene dichloride was evident in several areas. New asbestos insulating material was seen in one location. Propylene and methanol are used as a refrigerant and coolant, respectively. A bomb sample of VCM is taken at least once daily for laboratory analysis. A Japanese cannister mask with halogen filters is used for this purpose. Tar (heavy ends) are removed from one of the units daily by lifting a bucket from a filter. The tar is then allowed to weather on the property (presumably this activity also takes place in Kaoshiung.) To date one worker assigned to this plant from the main Toufen plant complained of an allergy to the vapors and has been re assigned. Several workers have indicated a dislike for the odor of ethylene dichloride. Only those workers transferred from the main Toufen plant have had physical examinations as part of the CGPC program. The new hires have not been sent for medical evaluation as yet. The nearest medical facility is at the main Toufen plant and I understand will be available, presumably on a limited basis, to these workers. Otherwise the local & -38- CUSAROSS 00239 hospitals and clinics in Toufen are used for emergency cases. There is no ambulance or vehicle suitable for stretcher cases on site. First aid training has not been given. Water comes from the Toufen city water supply or from a deep well at CPC. Industrial waste goes to the main Toufen plant holding pond for neutralization with the carbide slurry and then to the river. Raw sewage is piped directly to the river. -39- <* CUSAROSS 00240 CONCLUSIONS Medical Considerations 1. Although no clinical cases of acute or chronic toxicity have been identified, including acroosteolysis and liver cancer, in the workers exposed to VCM, PVC, solvents, mercury stabilizers, pigments and DOP, there have been numerous complaints of headaches, solvent odors and dusts and an absentee survey suggests that solvent and VCM workers have more absences than other groups. 2. Records of sickness absence are Inadequate to define problem areas within the factories. 3. Medical personnel, facilities and equipment at the Toufen Factory are inadequate to carry out an effective preventive medicine program. There is no on-site medi cal service at the other factory locations with the exception of the Kaohsiung and Waterfall plants where first-aid units staffed by physicians are available nearby and may be used by CGPC employees at this time. 4. The handling of emergency cases is limited by the general lack of 1) first-aid equipment on-site, 2) trained firstaiders and 3) vehicles capable of carrying stretcher cases. 3. The oxygen inhalation equipment in the Medical Depart ment at the Toufen Factory is inadequate for emergency resusitation and aspiration. 6. There are no occupational health physicians or industrial hygienists in Taiwan. At this time there is a major effort underway to establish a center for occupational health consulting services at the University of Taiwan, College of Medicine. Industry will be asked to partici pate. Two Chinese engineers sponsored by Philco are presently in a one-year course at the University of Washington in Seattle. 7. The DOL in Taiwan plays a similar role to the U. S. De partment of Labor by conducting factory inspections and recommending engineering controls and medical surveillance procedures. As in the U. S. the staff is too small and inadequately trained to carry out its functions and assure compliance. Nevertheless, they have visited the Toufen Factory. In addition, they have been known to make extensive and costly recommendations without supportive data. -40- ' 1' * CUSAROSS 0024] 8. A new occupational health law more restrictive than the U.S. OSHA regulations was passed by the legislation in April, 1970. It places the responsibility for health and safety directly in the hands of the factory manager or owner and specifies severe penalties, including prison sentences, for non-compliance. 9. Liver disease, specifically primary hepatoma, is very common in the Chinese population. Acute infectious hepatitis is uncommon in the adult; however, 20 percent are positive reactors to hepatitis B antigen. 10. The quality of laboratory services in Taiwan is highly variable. The laboratory presently being used in Toufen is inadequate. Local authorities seem to agree that the most reliable laboratory facilities in order of preference are the 1) Veterans General Hospital, 2) Taiwan University Hospital, 3) NAMRU-2 (not able to accept specimens from private agencies at this time), 4) U. S. Navy Hospital, 5) Private hospitals, 6) Private clinics (not recommended). Blood and urine lead and urine mercury analyses cannot be accurately done in Taiwan although NAMRU and the U. S. Navy Hospital have performed lead analyses in the past. Industrial Hygiene and Toxicological Considerations 1. Many workers are being exposed to concentrations of sol vents, mercury, stabilizers and VCM which exceed pre sently accepted (1973) U. S. Threshold Limit Values (TLV). These values which follow refer to time-weighted concentrations for an 8-hour workday and 40-hour work week. Since CGPC workers normally work a 48 or even 56 hour workweek their TLV's must be correspondingly lower. TLV (U.S.) MEK MI BK Toluene Me rcury Lead stearate Cadmium stearate Barium stearate VCM 200 ppm. 100 ppm. 100 ppm. 0.05 mg . /m-^ 0.15 mg./m^ 0.2 mg./m^ 0.5 mg./m^ 50 ppm. (c) (200 c) (proposed) (for lead) (for cadmium) (for barium) (temporary standard) -41- CUSAROSS 00242 2. Solvent, mercury and stabilizer exposures are of greater immediate concern than VCM or PVC exposures because of their greater potential for serious acute effects; how ever, the carcinogen potential of VCM is the overriding issue of the moment and will largely dictate the con trol measures. 3. Environmental monitoring has been sporadic and inadequate and equipment is not available on-site to assess the potentially hazardous exposures accurately. 4. Two CGPC employees in Toufen have been instructed in the sampling procedures and the use of the equipment to be purchased but neither employee has any experience or training in industrial hygiene. 5. Hygiene facilities and work practices in the factories are generally poor or unsatisfactory. Most factory workers eat on the job and lunchrooms are not available in all the factories. Handwashing basins are often inconvenient and in many areas are outdoors. Showers are very limited or non-existent and in some instances are poorly located. Locker and change room facilities are variable but generally inadequate. There are no set procedures for changing and laundering uniforms and, except for the mercury-exposed group, it is custo mary to wear work clothes home. 6. There appears to be unrestricted access to most operations including areas of potential exposure to VCM and PVC. 7. Noise is not a major problem in the factories although there are some jobs, e.g. boiler room workers, workers near the chlorine compressor, workers around refriger ation equipment and possibly others, who appear to be exposed to noise in excess of recommended levels. 8. Bacteriological analyses of "potable" water supplies is not done at any of the factory locations. 9. Sanitary wastewater receives no treatment at any factory location and industrial wastewater treatment is limited only to neutralization of the carbide slurry and the TVCM effluent in a holding pond at the Toufen Factory. Measurable mercury levels are found in the effluent and annual payments are made to local farmers. This pre sents a serious potential health problem which is presently under consideration by CGPC. Local regula tions are evidently becoming more restrictive and will necessitate action by CGPC in the near future. -42- CUSAROSS 00243 10- Lighting in the factories is variable and in some opera tions, i.e. soda flake area, is insufficient. All lights in most areas were turned on during my visit, which may not reflect the usual situation in view of the current energy crisis cutbacks. ) CUSAROSS 00244  REFERENCES 1. Newspaper articles 2. Kentucky Vinyl Chlorid1 e Standard 3. NXOSH Recommends Zero Threshold for Vinyl Chloride 4. NIOSH recommendations for Work Practices and Medical Surveillance of VCM and PVC Workers 5. OSHA Emergency Temporary Standard on Vinyl Chloride 6. National Surveillance Registry 7. Kodakisa Report on MBK 8. Health Hazard Evaluation of Meat Wrapping Employees 9. Markowitz, S. S.,et al. Occupational Acroosteolysis. Archives Dermatology, Vol. 106, August 1972 10. Getsios, C. T. Acroosteolysis in PVC Workers. Pre sented at the Sixth European Medical Directors Meeting, Standard Oil Company; (N.J.), Paris, France, 1970 11. Yagaguchi, S., et al. Occurrence of Alkylmercury Compound in Caustic Soda Factory. Archives Environmental Health, Vol. 23, September 1971 12. Viola, P. L. Pathology of Vinyl Chloride, del Lavoro, Vol. 61, March 1970 Medicina 13. Viola, P. L. Cancerogenic Effect of Vinyl Chloride. Presented at the Tenth International Cancer Con gress, Houston, Texas, May, 1970 -44- '4. *' > CUSAROSS 00245 , , Vi-d-'Jir' c-tr *,' tin ^nalli * Ifij:?*';y*G*r*'jft`"*t - - - Hi Wall Street Journ-al, Thursday, January 24, 1974 4:- I Three Cancer Deaths May Be Job-Related, : B, F:Goodrich Says *0 Former Fmploycs at Louisville l'lant All Were Involved in Tolyvinyl Chloride Operation^ t:u <t \Vu, RtUKkt Joimixat. Sin/t Repnrttr AKRON, Ohio -- D. K, Goodrich Co., In a move that sent ripples through the plastics and chemicals Industries, said it is Investigating the possibility that the cancer deaths of three workers at n plant In Louisville, ICy., may be job-related. Goodrich said that Iho workers affected were in its polyvinyl chloride operations, and that they died of angiosarcoma of the liver, a rare form of liver cancer. Dr. Maurice N. Johnson, Goodrich's direc tor of environmental health, said in the compa ny's statement Unit he had recently received medical reports concerning the death of an em ploye In late Deemhor. "A review of medical records uncovered that two other employes had apparently died limn the same cause-one In September lt)7i and one in March 1973," the company said. It was understood that a fourth death--In IDtiR- involving a mom common form of liver cancer was cun. idered outside the reasonable bounds of llio "grouping" of the three recent deaths, all atti ilmlcil to angiosarcoma. Goodrich s,mi ii laid Informed Kentucky health offii i ds and Iho Federal National Insti- lulc of Occupational Safely and Health that the eompanv was investigating the possibility that the deaths might ho "related to occupational causes.'' '- - -t Will Begin lMvesllg:itioir'''''"'^;rw:i^'>*'^i^*t ` Kentucky ''officials''- -said' thcy ^Tiad#jltst learned of the situation at Iho Louisville, plant ! and had asked a medical .mcnert to invcsligale., I In'KockvUlc. Md`7a Spokesman'for NIOSH said a team of experts will auiyg.ln Louisville this moffiWg to-begin nn investigation. pr. Marcus.it, Kcy.nUwitpjcgjpfJtlOSH^ald' the institute also will .step, up efforts.to deter mine the extent of angiosarcoma in the U.S., end in foreign countries with similar manufac turing processes. A spokesman for the Institute said the best information available shows 21 deaths per year in the U.S. attributable to an giosarcoma. Tho recent deaths at Triulsvillc, according to Dr, Johnson of Goodrich, Involved workers In the company's vinyl products operations. An official of NIOSfl said he understood that the workers had ah average of 20 years' exposure to various chemicals and agents Involved In vinyl operations. Goodrich said it has been conducting a pro gram to reduce exposure to hydrocarbons, par ticularly vinyl chloride, throughout Its opera tions. Further stops to limit exposure and to describe tho situation to workers In vinyl producti production-arc bojng taken, company ,, t yfrr -f , -V.7-, , vt.'tjftvs r Goodrich also said It t providing medical examinations to all employes Involved In Rny phase of vinyl chloride or polyvinyl chloride production, and Is reviewing nil Its medical records of former or retired employes. About 1.200 persons work at the Louisville plant, of whom about 270 arc Involved In vinyl products operations. "Dropping of a Bomb" Word that the deaths might be job-related spread quickly throughout several industries. Said Louis Beliczky, an industrial hygienist on the staff of the United Rubber Workers union, which has many members Involved In vinyl ; operations at various companies: "I look at this as the dropping of a bomb. It opens tip the possibility of a whole new occupational dls- 1 ease." ` Mr. Beliczky said lie suspected there might be a connection between the Goodrich prob lems at tho Louisville plant and the problems of Borden Inc. at a vinyl-materials plant in Co lumbus, Ohio. Workers at the Borden plant for several months have complained of a variety of ailments, some believed crippling, which they allege are connected with working condi tions. ^ ?v .. .A medical, expert at N1QS11, however,..said he doubted Uio difficulties at the Lvo-plants were related. He asserted that the problem at ' -toqjjt . the Borden plant has bccn,definedi`a'?Tp'cripli-J.,_;~,,,. V S.I'' ci^^europathy,^dis^en^WtThf,'nltacl!ft>hervcs<^fnSsjS(jl that control mUsclcs in human limbs. Thcdivcr * afflictions at the Goodrich plant seem unre- lated Jo^tbe problemy^LBorden.hoSiiid.^ijg-jjygMigfcjjs,^ ' Goodrich lias `four%ther 'polyvtnyr'chlonae^*8 "plants--at Avon Lakel'Ohlor CaIVcH City, Ky1mm' ***** Long Beach, Calif., and Henry. lll. m? yc-.-' m* 4 CUSAROSS 00246 PUP**' Saturday, Jan. 16, I* THE WASHINGTON POST . * Liver Cancer Cases i Spur Plant Inquiry By Stuart Auerbach Wuhlmton Pail null Wiiiti Deaths from a rare form of liver cancer of three workers In a Louisville plastics plant has led to a federal Investiga tion to see if they were caused by the chemicals used In the plant. All three men weie long- time workers In a R. F. Goodrlrh plant that makes polyvi nyl chloride*--a plastic used in phonograph records, pipes for the construction industry, hot. tie;;, packaging, car upholstery and vinyl tops for automo biles. The men died of angiosar coma. a form of iiver cancer that kills about 23 Americans a v'.ir. Two of the men died ilast year. In March and in Deiconiher, and the third died in September, 1971. "Certainly two deaths in one jorinthc same plant, among ro-.corkers almost; out of 23 in the entire United States Is enough to heighten suspicion thr.t chemicals m (he plant catscd the deaths." said Dr. Vernon Rose of the National Institute of Occupational Safety and Health, who re turned yesterday from an In spection of the Louisville plant. B. F. Goodrich said In a press release thatit was inves tigating to see If the deaths "were related to occupational causes." The deaths caught experts in occupational health hazards by surprise. One man said that polyvinyl chloride had not been thought of as a cancercausing agent and was not even on lists of chemical com pounds that should be studied , for their possible cancer-caus ing effects. Although vinyl chloride, normally a colorless gas, is the main component of the plastic polyvinyl chloride, about 50 other chemicals are used in the plant. Company officials provided the federal Investiga tors with a two-page list of chemicals that could be In volved In the deaths. "There Is no question." said * Rose, "as to the fact that the exposure to chemicals are nu merous." The company's own investi gation started last week when Dr. Maurice N. Johnson, BF. Goodrich's director of environ-' mental health, received an au topsy report on the man who died in December. This report had been fur nished to the plant physician in Louisville, Dr. John Creech, . by members of the worker*! family. / Deaths from liver diseases , are always considered suspi cious in the chemical Industry, * B.F. Goodrich spokesman 1 John Bell explained, because of the danger of exposure to unusual concentrations of hy- ' drocarbons. i ; Johnson checked the medi cal records of other employees 1 in the Louisville plant and ' found that two other men were reported as dying of an- ` giosnreoma. The three men 1 had an average of 22 years ex posure to chemicals working In the plant. In addition, Rose said, a .fourth employee was reported as having died of an unspeci-j fied form of liver cancer. I Federal officials are now(. 1 seeking to confirm the causes i of death of all four men. "There Is no knowledge nrL record of any similar circum stances among the four other , B. F. Goodrich polyvinyl chlo- . ride plants," said Bell. 1 Nevertheless, the company 5 said it has tightened its safety standards to minimize em- ; ployee exposure to the chemi cals. Company officials said ' all five plants arc operating| within federally approved lev' els. Rose said that federal ex- pert* will spend the weekend finding better wavs to keep 1 the plant, which was built in | the 1930s. from being contaml-j ' nated by chemicals. j t CUSAROSS 00247 More Cases of Liver dancer Are Reported Among Workers at Virpyl Chloride Plant By Jonathan Spivak, Alexander Reis, an official of the Occupa Staff Reporter at Tut XVall Stukst Jovjuial tional Safety Agency, said the decision on WASHINGTON - Scientific evidence is emergency regulations would bo made only leaf tjuUfbe wiMy used Industrial chem- Vffad' flfrfeida' fosses mmr>r lawcefc after additional information front current gov- el* <$!$V)t. ernmant 'ad InduaCry studies was available. Jha^ health gad industrial bdpiloa- "About to* mity.firing that is dear is the exist- tlaas an serious n4'eabstanfial, government ing standard will have to ba changed." Air.1 xpde ay.^'We arefaoed wttha mw occupa- Bell said. 1 ; tiooaT&MtM*! There la no sepse denying it," The HEW institute la urging that the Labor ststW' John O'Neill. chibf of' the division of Department act as promptly as possible by health standards In the Occupational Safety .Issuing rules requiring vinyl chloride manufac a^ll^JtbOAdmlpiirtrfttion. : turers to operate under a so-called "dosed sys vW?e(lf 'c< vinyl chioridp',ji hazards tem." Thtemaao* that workers would be fully means'4 tnaj&rjohattgjp in manufacturing .prao- protected against* any expoeura to the chemi tios will bsnrogwery to reduoe weskers* expo cal. audit would rojgjriiw significant changes in sure MR. raddrel uifi private Industry experts manufacturing penasWas, government special, are wriklngoa a high-priority effort to deter lots aay. The HEW recommendations also mine tfo exaM' extent of risk tram the sub would call for monitoring of the environment in stance nuf what briber precautions MU be the plants and medical teats cf workers to de 'needed, , ` -*/ ' * >, % termine whether they are beginning to experi Vinyl' chloride fie used in malong a wide ence adverse effects. Thb institute also la urg array of pUriicr. including pipej^'floor/Bids, ing that ttiers be warning placards in manufac records end Other oonsumer products. It* no** taring arses and that employers be required to maltyU,* gnw and is oonvertedln. monufactur* provide Specific Warning information to m mg tomaterial oaUad polyvinyl chloride,, a ptoyea. powrfejty substance that ** then converted Into finished*producUf; i.'* 4s - ' * Meanwhile, government and industry arc accelerating efforts to determine the extent of Tim^Srat Urm indications of the chemical's the problem and to detensina more definitively posstwe danger came,list month wlttttha re the role played by vinyl chloride in Us cause, port bjfB. S'. CWodrlchtJhemlcal Co., a dtvlsicst the Goodrich Louisville plant was cm of the of B. 9. Goodrich Co. , *that it had been deter-_fi_rs__t to begin production of the plastic comp.)- mined that four workers at iU Louiavtile^Ky.,1 pent i Worid War II and the type of cane.'r plant, which converts vinyl chloride Int^'-fewSt^ >$n Its pmpteyas is one that ink. vinyl dtbtoride,, had died from a hare tyfoif , liver egAceg' caUri^angloeicarcain*. This' mpny ' -' * j which effects the blood vessels of. the : ***<!1-- c-. I thought to occur among only 2S persons tt least 14 year* before the Ulnnss. | nationwide. Thus, the cluster at the 'An initial govan*mer!t Step win be to surv< ' plant, the largest manufacturer ot riper vinyl chloride plants, particularly tho < ! chloride in the nation, stirred lmmedia mb.; involved ta conversion of via> 1 chloride to pol i com. ifUtvl chloride. A duster of such plantaoccur h j Than, over the weekend federal authorities j Glpo, Kentucky and Pennsylvania, reported two more cases of angiosarcoma at I l* addition, government specialists point ooi the Goodrich plant, bringing to six the numberj ***** * examination should be made of co occurring there.,"TWs makes it a bigger jripWs riimers* exposure through tho use of produc lem than we had believed," declared Marcus? detaining polyvinyl chloride, although th--' Key, director of the National Institute fof Go-' 0"rr<mUJ' *** "P evidence ot risk in the cupational Safety and Health, which makes set-} "We are talking about levels (of expo- ; entitle recommendations to the Labor Depart-* 4?*) ** l****** **** *** UoWvd only in the ment. The institute larpart of the UMlt t, fedu-j **fkStrial jenvtronmant," print* out Dr. Clark cAtlm and Welfare Department. | Haath, ri^if of the cancer and birth defects di- So far, however, KMeral autborittw arrot! at IfBW'a OtnUr lor Disease Control, prepend to assert specifically that ytnj 1 '* " *y ' ida papefe liver cancer. 'They note,' aid kg jam ,.J Goodrich officials, that Workers at 4ha ' ny*e plant are exposed to & variety qf^ other The* Wall Street Journal chemicals Involved in the conversion Of Vinyl clUoride to polyvinyl chloride. But the rinum- Tuesday, February 19, 1974 stantial evidence is Increasing, and a strong case is buildjpg from records of human cancer and anljhal Wperimentg that & gubetantial health problsm has bepn uncovered. The immediate issue is what new precau tionary Mesisures should' be taken to protect worker#.1 Somq B.600 employes fit 37 plants op- erased' by tg. U.S- manuf&oturers are lnvrived. Union reprssSptatlvM ha^e urged the Occupa- ttoagi Safety kAgency to Hbsu an immediate order tight*pfiig'Jts existing limit of S00 parts par Vnllllcm in IMS, Atmosphere. Industry repre- seahatives, TuwtevetV urge that the Labor De partment take ihore time ir. investigating the proiiem and Iasuo ,lta new regulations under Uajal^pippcdures. which permit a public hear ing hqfode they go into effect. CUSAROSS 00248 THE CHINA NEWS TAIWAN t^bbto; Vinyl t ST. A0CtISrWE, Jlorida-- Louisville, Kentucky, reported . (l/Pj>^ResearchW,#^e<^ "Fri- two fatal relives cancers amo^g 'day that a reCe^iV djfe:bvery`' th,at;' workers tai ihe company's yrpt .vinyl chloride mnybatise"' iiver chloride pl^nt. ttve ^tpidre oases , 'cancer among dieHtedi workers were .found pijmt ftpdiiince suggest*" That othejf ' substances then otheb cases haye .bce^ foupd eaten and/hthaled-by1- bupians among vinylin. Now., may also-produce 'ifancer.'^' ' YorkfTeWW^firgipi^^ Drs. E. (5uy)er HWuhoctf'of That type of dancer.,had beejr the American Caric<fr`Sogiety and* ra/e 'and'Hatnmon<33%nd Seiikoff Irving S' e.i.i.kojf.f of7the ' Mount said it only1 because of its Sinai Schorfl of Medfcine tn'New rarity that the vinyl'chloride fink' York saidtflere':ist ah 'tirgent'need was fotmd.>,'An/American cancer' to search 'i<yaagfetS^whjfcH`iipi5(y-. society research: prpjeer is' 'haw ' be causing^anci' r i frh^wtffSho'W*' ing to defiSirnlne if workers in '' up years- from'now. factories -"which manufacture "Our world is , changing and, especially fn the" past 40 years, the environment in which we live has been altered' foaff extraordin- yinyl plastics are 'endangered/'or ff consumer- products containing traces ` at vinyl chloride are hazardous//''''- ' ' ary extent," fhey' sEtd- in a padfej1 prepared fora softnde i writers seminar sponsored by* the^cancer society.' ' "The alft'CVe breathe-`contains gases and pustioles'thu never betfore entered the human lung1. Out'' food has; chemicals designed'to improve' .its., taste, freshness(, ap-. pcarance, but*wJuefc are'strange to our intestines;'lh4eut kidneys, blood. Wertt>uclv inhale, absorb an ever-incfWingnrpumberc Of synthetic materlateiahd, in other cineumstanaeSLageet* whicAenay | have existed on eottfe butv.werc J never part qt.tbe jfpp^diate fruman envy;i Ut"r. Hammotto and i^Jtkoff poipted out that it is,J)elieve4.85 percent of all canccfj is derijfpd from en- vironments^^ource^'They s^id new agents are rapidly bfijpjp spread among tens of'miHions of people without' pre-'t$*ting to see i if they caB^cahdta^or othercl^jJ eases. , * ; >* i 1 l-1.' /iyl "A useful chemical dr an- ef ficient plastic soon permeates a ] nation, or large part hf .the World# There is -'literally no place' to" hide." The vinyl chloride problem surfaoed in January when officials ; of the &.P."Goodrich, Co: in ' H, I CUSAROSS 00249 Kentucky STATE STANDARDS BOARD ADOPTS 50 PPM TWA FOR POLYVINYL CHLORIDE STANDARD Kentucky's standards board amended the state's perma nent carcinogens standard on February 19 to include a 50 parts per million limit of polyvinyl chlorides in air as a time-weighted-average (TWA), Labor Commissioner James Yokom, told OSHR. The board adopted the TWA at an emergency meeting held following the deaths of workers at the B.F. Goodrich plant in Louisville, Ky., from angiosarcoma of the liver, a cancer attributed to exposure to vinyl chlorides during a polymerisation process (Current Report, February 14, p. 1164). The amended standard will become effective JO days after filed, Yokom added. It is currently being reviewed by the state Legislative Research Commission as a matter of procedure and will be filed shortly. In addition to the 50 ppm TWA, a ceiling value of 75 ppm lor 15 minutes of worker exposure was eslablishcd by the standard. Workers cannot be exposed to more than 75 ppm of vinyl chlorides for more than 15 minutes at a time without use of protective equipment, according to the amended standard. Protective equipment required, medical checkups, and recordkeeping, for polyvinyl chloude exposure is the same as required for other carcino gens under the state standard. The standard also sets a value of 200 ppm without use of protective equipment to be considered and treated as an imminent danger situation, Yokom said. The standard will require all companies using the chemical in the state to register with the state labor department by July 13. Under the carcinogens standard, the first 13 carcinogens must be registered with the state by June 13 at (he latest. CUSAROSS 00250 Health Hazards NIOSH RECOMMENDS WORK PRACTICES . DOCUMENT FOR VINYL CHLORIDE WORK Any employee exposed to measurable amounts ol' vinyl chloiidc should be required to wear an air-supplied res pirator, according to a recommended standard Cor manu*. facturc of synthetic polymer from vinyl chloride devel oped by the Nalional Institute for Occupational Safety I and Health. * The NIOS1I documcul was sent to the Occupational Safely and Health Administration on March II by Ur. Maicus Key, NIOS1I director. I he document was prepared following the iiulustiy-wide scale dial resulted from the announcement that several wot hers at the U.l;. Goodrich facility in Louisville, Ky., had died fioin angiosarcoma of the liver, an extremely tare disease (Current Report, January 31, p. 1099). In a memo to Assistant Labor Secretary John H. Slender, Key said the consultants from industry .who worked with NIOSH on the standard recommended the rule contain the concept of an allowable working level for vinyl chloride gas in (lie atmosphere, which the consul tants identified as a lime weighted average of 50 parts per million. The consultants recommended that where woikers were exposed to concentrations in excess of this level they be required to wear respirators. The concept of an allowable "working level" might seem justifiable in that the Italian icsearchct Professor Maltoni found no liver tumors at 50 ppm. Key said (Current Report, 1-cbruaiy 21. p. 1189). However, there is (he possibility that tumors might have been produced if a larger number of annuals had been exposed at that concentration. Rased on theoretical considerations, there is probably no threshold for carcinogenesis although it is possible that with very low concentrations, the latency period might be extended beyond the life expectancy, Key said. "In view of these considerations and our inability to describe a safe exposure level as required in Section 20faJ f31 of the Occupational Satety and Health Act, we rejected the concept of a threshold limit for Vinyl chloride gis in the atmosphere.' Consequently, the NIOSH recommendations as con tained in the recommended standard are such that where any employee is exposed to measurable concentrations of vinyl chloride, as determined by the recommended sanipiing and analytical method, lie shall wear an air-supplied icspiratoi, Key said, this iceommendation is based on some pieliminary information that the standard chemical c.utridge icspirators arc incflicicnt in protecting against vinyl chloride. NIOSH is conducting a study to evaluate the degree of protection allorJed by different types ol respirators using vinyl chloride as the test gas. U> VJOllfX ICLlMlIIIMluauuiui IVU anvuiumv usage. Key said. The employer is also required to develop a control plan to reduce airborne concentrations of vinyl chloude to levels not detectable by the recommended method, v fhe NIOSH recommendations for a standard for vinyl , ihloiidc appear in the Lull Text section of this report. / V, n. 3 CUSAROSS 00251 h. Medical Surveillance * i' ` ` The following recommendations are directed -primarily at medical screening to detect liver disease and/or hepatic tumor. They-should be considered in the context of routine health screening for any general employee health problems, including non-hepatlc health conditions po tentially related to vinyl chloride monomer exposure. Routine health screening should include at time of initial employment the recording of past medical history and the performance both of a general physical examination and certain basic laboratory procedures (e.g., complete blood count, urinalysis, chest x-ray); provisions should.also be made for rou tine periodic health follovyp examinations. Employees covered by the following specific recommendations shall encompass all persons engaged in vinyl chloride monomer production and polymerization, including personnel peripherally Involved such as in clerical and management assignments. The recommendations shall be applied both as a pre-employment requirement and as part of periodic health follow up. Screening priority should be given to current employees with prolonged and close potential exposure to vinyl chloride monomer* whether in present or past work settings. (1) At time of initial employment, or upon Institution of screen ing, physical examination stall be performed with specific, attention to detecting enlargement of liyer or spleen by abdominal palpation. (ii) At time of initial employment, or upon institution of screen ing and annually thereafter, a medical history check-list shall be com pleted by the employee. This list shall Include questions concerning: (a) alcohol intake (b) past history of hepatitis (c) past exposure to potential hepatotoxlc agents, including drugs and chemicals. (d) past history of blood transfusions (e) past history of hospitalizations Completed medical check-lists shall be reviewed by a physician and should be acted upon as medically indicated for each individual employee. (Ill) At time of initial employment, or upon institution of screening, a serum specimen shall be obtained for screening with respect to the following five bio-chemical determinations of liver function: (a) total bilirubin (b) alkaline phosphatase (c) serum glutamic oxalacetic transaminase (SGOT) (d) serum glutamic pyruvic transaminase ..(SGPT) (e) gamma glutamyl transpeptidase (GGTP) *?. CUSAROSS 00252 Additional tests that may optionally be considered for use in screenings include lactic dehydrogenase (LDH), serum protein determinations, serum orotein electrophoresis, and platelet count. Laboratory analyses shall be performed in laboratories accredited by the College of American Patho logists or licensed in accordance with the provisions of the Clinical . ;, laboratories Improvement Act of 1967. (iv) If results of laboratory screening are normal, screening shall be repeated on an annual'basis. If the person beina screened has been em ployed directly in vinyl chloride monomer production or polymerization for 10 years or loneer, screening shall be repeated every 6 months. (v) If one or more liver function tests are abnormal, serum test ing shall be repeated as soon as possible, preferably within 2 to 4 Weeks. If no abnormalities are present upon rescreening, testing should be repeated in 3 months. 0 (vi) If abnormalities persist on rescreenlng. the employee shall be removed from contact with vinyl chloride monomer operations and Individualized medical workun shall be instituted. Suggested as initial steps in medical workup are a complete physical examination and various special procedures such as hepatitis B antigen determination and liver scanning. If liver function abnormalities are determined to be unrelated to liver disease (e.g., elevated alkaline phosphatase in a young, physically active man or elevated bilirubin in Gilbert's syndrome) or to be transient (e.g., due to recent hepatitis or recent alcohol intake), the employee may be per mitted to return to vinyl chloride-related employment, subject to individual medical evaluation. (viii) In view of the preliminary results of animal toxicology studies, it is recommended that no woman who is pregnant or who expects to become preg nant should be employed directly in vinyl chloride monomer operations. Af.t;-. T i ` -jV.., `. 1 ` ) CUSAROSS 00253 CURRENT REPORT f/CP. 1311 NIOSH RECOMMENDED OCCUPATIONAL HEALTH STANDARD FOR THE MANUFACTURE OF SYNTHETIC POLYMER FROM VINYL CHLORIDE March 11. 1974 1. .ST Y)/7, .1.17) A ITUCA HON Hits staud.ud regulates tin1 manufacture of synthetic polymer hum vinyl chloride (clilorocthcnc, Chemical Ahsliacls Uet'.islry No. 75014), in order to protect the health and saletv of workers. Vinyl chloride also known as vinyl chloride monomei (VCM), chlorocthylene and ehlorocthenc, is a colorless sweet smelling gas at ordinary temperature and pressure and has a boiling and melting point at one atmosphere of -1.1.8 degrees C. and -153.71 degrees C, respectively. Its chemical formula is CIDCHCI and it has a molecular weight ol (>3.50. Although noncorrosive at normal atmospheric tem|>erature.s, in contact with water and at elevated temperatures it accelerates the corrosion of iron and steel. Ol' considerable concern is the fact that vinyl chloiidc is easily ignited and has a lower and upper explosive limit of 3.6 percent and 26.4 percent, respec tively. 2. DEHNITIONS I oi the pm pose ol this staud.ud: a. '`Assistant Secret aiy" means the Assistant Secretary lot Occupational Sulely and Health, U.S. Department of Libor or any person directed by him. h. "Directin'' means the Director, National Institute loi Occupational Salety and Ilealth, or any person direct ed by him or the Secietary of Health, Education, and Welfare to act lor the Diicclor. e. "Authorised employee" means an employee whose duties iei|inre him to be in the regulated area and who has tieen specifically assigned by the employer. d. '`Detectable levels" means the determination that aiihoinc concentrations of vinyl chloride are in excess of the limit of sensitivity of the sampling and analytical method recommended by the Director. *> e. "Clean change room" means a room where employ ees put on clean clotliing; clean change room shall be contiguous to and have an entry from a shower room, when the shower room facilities arc otherwise required in this standard. ' f. "Closed container" is any container which is used to picvcnt the physical contact of employees with material containing vinyl chloride monomer. g. "Closed system" means an operation involving vinyl chhuide where containment prevents the release of vinyl chloiidc into regulated arcus, nonrcgulated areas, or the external environment. h. "Contaminated" refers to detectable levels of vinyl chloride monomer. i. "Decontamination'' means the inactivation of vinyl chloiidc to less Ilian delectable levels or its safe disposal. j. "Dispos.il" means the safe removal of vinyl chloride Irom the work environment. k. "Emergency" means an unforeseen circumstance or set of circumstances, such as a ruptured transfer line, resulting in the release of vinyl chloride sufficient to pioduce acute symptoms among workers exposed or having contact with the vinyl chloiidc, I, "External environment" means any cuviioumcni external to regulated and iiuurcgulatcd areas. in. "Regulated area" means an area where entry io and exit Irom a vinyl chloride workplace is restricted and controlled. n. "Nonregulatcd area" means any area under the control of the employer where entry and exit is neither restricted nor controlled. o. "Protective clothing" means clothing designed to protect an employee,against contact with or exposure to vinyl chloride. p. "Waste resin" means any resin oi otlici vinyl chloride reaction product which has been removed I mm vessels during clean-up operations, or which has been collected as a result of in-plant housekeeping operations. 3.REQUIREMENTS FOR REGULATED AREAS A regulated area shall be established whoie'syniheiic resins containing vinyl chloride are manufactured, I licsc regulated areas shall include but are not limited to vmvl chloride loading or unloading operations, siuiajv, and transfer facilities; synthetic resin polymerization pioccsscs and operations; and icsin handling, compounding, p.it.k.ly ing and storage aicas. Access shall be restricted to nuthoiized employees only. All such regulated areas shall be controlled in accordance with the Ibllowing requirements. a. Routine Operations (i)Initial concentration of vinyl chloride in all regu lated areas shall he determined by performing ait measure ments at strategic sampling points under tioimal opoiating conditions. These initial sampling points must be selected by a professional industrial hygienist and will serve as monitoring locations for future environmental measure ments. The sampling pattern shall be adequate to represent tfic environment of the controlled area. . (ii) Where detectable levels of vinyl chloride arc^ I measured, a Control Plan to reduce such levels shall be dcvclopcd and implemented. The Plan shall consist not only of establishing goals for reducing vinyl chloride levels by designing and intinducing engineering and process controls, but shall also identify plans for developing additional (healthful) work practices. Target dales shall be established for ail goals and the Plan must be updated at least on an annual basis. Copies of the Control Pltin shall be posted in all regulated areas and be provided to all authorized employees. (iii) There shall be periodic tests for process or equip ment leaks and for emission of vinyl chloride which may result from work practices. The frequency of these tests shall be such as to insure the integrity of equipment, adherence to proper work practices, and to determine achievement of the goals of the Contiol Plan. Tests shall be performed at each sampling point at least daily or f h i 4 f f- . C U S A S S 00254 1312 OCCUPATIONAL SAFETY & HEALTH REPORTER _ more frequently if concentrations ol vinyl chloride arc in ,^^^'cxccss of those established in the Plan. When such levels TM'iiir exceeded, additional samples to identify sources of contamination shall Ire taken. Results of all such tests shall he made available to authorized employees in such a maimer as to evaluate achievement of goals contained in tile Coni ml Plan. (iv) Until expOMites to vinyl chloride are reduced below detectable levels, employees entering any regulated l aiea shall l>e piovided with and requited to wear and use \ a lull lace, supplied air lespiialor, ol the continuous llow \ 01 picssine demand type in "accordance with S 1910.11^ (\")Tti opeiaiious involving loading or unloading vinyl chloiide monomci liom lank c.iis. I nicks, lunges, or oilier conveyance equipment, each lunslcr line and each vaporI'quali/mg line shall Iv 'equipped with vent connections pcmulliiig. al tin- completion of the Iransfer, pressure to Iv \enled and the hose pinged with an inert gas in such a mantlet to pieclude any employee c\|v>surc. Specific and detailed lianslei pnvednrcs shall he developed and pro vided to involved employees in wiillcu form. (vi) I inplovees shall Iv piovided vvilh and required to \ weal, clean, lull-body piolcclivc clothing (smocks, covcr\ alls, nr long-sleeved shirt and pants), and gloves prior to, 1 enteniig. llie ivgulalcd aica. (vn) Ptior to each exit liom a regulated area, employr ees sli.ill Iv iet|uiied lo remove and leave protective > clothing and equipment at the puml of exit and at (ho /SfiLisl exit of the day, lo place used clothing and equipment '|l impeivious eonluineis al the ]>oint of exit lor purposes of ileemitamiiiulinn 01 disposal. 'I ho contents of such impeivious couinmeis shall lie identified as required under patagiapli e(2) (i) of this standard, h. Kcact<>r iiiui IVssi7 / ntrv (il A teaetoi and vessel enliy piivedme shall be dcvclopeil ami piovided lo involved employees in written form. Emplovees shall he lamili.ui/ed with the procedure and shall Iv tmined and icheaised in llie techniques provided fm in llie pioceduie. Emphasis shall not only be placed on concern for potential exposuic to vinyl chloride but shall also include appropriate precautions for entry into eon lined spaces. (ii) Techniques shall Ire developed and applied to mini mize to llv maximal practicable extent employee exposure to vinyl chloride -when opening any closed vessel. Examples of effective methods arc the application of heat or suction lo the vessel prior lo opening, or use of sullicienl exhaust ventilation around the vessel. Where opeiaiious such as cleaning or maintenance conducted inside an open vessel could result m the liberation of vinyl chloiide, suitable piocedmes such as exhaust ventila tion shall he develop'd and implemented to insure that vinvl chloiide is not released into the general work environment. (iii) Exhaust ail shall not tv dischuiged lo regulated A^'^M tas, nonicgttlaicd a teas, or the external environment V decontaminated. (iv) All piping lo and from the vessel shall be blanked or olheiwisc isolated poor lo entry. | (v) Em ploy ocs cnteiiug the reactor or vessel shall be novided with and required to wear and use a full-face, supplied an lespirator, of the continuous flow or pressure demand type in accordance with 1910.134. (vi) Employees entering the icaclor or vessel where levels of vinyl chloride arc monitored and are found to not exceed ambient levels external lo the vessel shall he provided with and required to wear clean, lull body i piolcclivc clothing (coveralls or long-sleeved shirt and I pants), gloves, footwear or loot coverings, and head : cowling. Wlicic vessel levels are in excess of ambient levels, employees shall instead be provided with and icquned to wear impervious clothing lo prevent skin contact of vinyl chloride or other materials containing vinyl chloride. (vn) Aflc'i each exit liom the icaclor or vessel, employees shall Iv icquired lo remove and leave pmtecnve eluthing and equipment al a designated point m the legulutcU area, and al the end of cadi work shill to place used clothing and equipment in impervious but vented eonluineis for the purpose ol decontamination oi dis posal. The contents of such impeivious containers shall he identified us required under paiagmph c(2) (i) of tiiis standard. (viii) Employees engaged in icaclor cleaning or oilier opeiaiious involving vessel entry shall shower at^ the end of llie work shift. c. Maintenance and Decontamination Activities (i) Emphasis shrill be placed U|xm immediate clean up ol spills, periodic iiispcclion, piompl icpair of equipment and leaks, and proper handling, sloiage and disposal or decontamination of materials to prevent an borne contami nation and accidental skin contact with vinyl chloride, because vinyl chloride is a gas al normal temperatures, wasie maleiials, equipment, and oilier sources of the monomer in closed containers, shall not be placed in areas of excessive teni|)cralurc oi sunlight since build-up ol internal pressure may result in rupture of the container, llie or explosion (u) Wasie icsms or other materials contaminated with vinyl chloride shall be placed in dosed containers identi fied as required under paragraphs c(J) (i) or (ii) of this standard. (in) Appropriate procedures shall be developed and implemented for the decontamination and/or disposal of all such waste material. (iv) In clcari-up of leaks or spills, maintenance or repair operations on contaminated systcms'of equipment, or any operation involving work where direct contact with vinyl chloride monomer could result, each authorized employee involved in such operations shall be provided with and required to wear dean, impervious garments, including gloves, boots and continuous air supplied hoods in accord ance with 1910.134, be decontaminated before remov ing llie protective garments and hood: and be required to shower upon removing tire protective garments and hood. d. General Regulated Area Requirements i. I-.niployce identification, A daily roster of employees entering regulated areas shall lx- established and maintained. The rosters or a summary of llie rosier shall be retained for a minimum period of 20 years by the employer or successors thereto. The rosters and/or summaries shall be provided upon C U SAKO sS 00255 R.f CURRENT REPORT 1313 request to authorized ivptcseulalives of llic Assistant CANCER-SUSPECT AGENT AREA Seciet.uy and (lie Diicctoi. In Hit? even I llial tin? employ AUTHORIZED PERSONNEL ONLY er tease* business williout a sueeessoi, iosiers shall be lot warded hy legislcred mail U> ll>e Director. (ii) Entrances to legulaled areas containing opeiations covered in paragraph 3(e) of this standard shall be posted 2. I\nieigcncies. with signs bearing the legend: In an eineigeues , immediate measures iiictiulitij*. but mil limiied to the iet|iiiiemeuls of subdivisions (i). (n>. (fiiI, (iv). anti (v> of this subp.nagiaph shall he implemeiiletl. (0 The polenlially allecled aiea shall be evacualed as sot'ii as (he existence of the emergency lias been detei- minetl. (ii) lla/ardous conditions created by the enieigeney shall he eliminated and the potentially affected aiea shall be decontaminated prior to the resumption of uoinial operations. ' (iii) Special medical suivcillatice by a physician shall he instituted within '4-hoius for employees piesent in the CANCER-SI ISP l-CT AGENT IN THIS AREA. IMPI K VIDUS SUIT INCLUDING GLOVI-S, IKK MS. AND AIR-SUPPLIED HOOD RE0UI RED AT All. TIM! S AUTHORIZED PERSONNEL ONLY. 2. Container contents identification. (i) Containers of waste oi other maleii.ils imnlaunuaied with vinyl chloride shall he labelled as follows. VINYL CHLORIDE CON I AMINATi l) MA l I.R1AL CANCER SUSPECT AGENT DISPOSE OH OR DECONTAMINATE. USING APPKOVI-D PROCEOUKI S potentially affected aiea at the tunc of the enieigeney. A (ii) Containers, of synthetic polynias made hum vinyl repoil of the medical suiveillauce and any treatment sha chloride shall be labelled as follows: he included in the incident report, In accordance with paragraph (fa) (.0 of this standard. (iv) Where an employee has a known contact with liquid vinyl chloiide such employee shall be requited to slmwei as soon as possible, unless contraindicated by pliysiv al injuries. (v) An hrid' iiI tepoil on the emergency shall be icpoiled as piovnled in paiagiaph (g) (.1) ol Ibis slamlard. 3. llvyji iit lacihiH s and practices. (i) Sloiage oi consumption of food, slot age oi use ol com.nuns ol bevei ages, storage or application ol cosmetics, smoking, sloiage o( smoking materials, tobacco products oi oilin pioducts lor chewing, or the chewing ol siiji products, .tie prohibited in regulated areas (ii) Wlme employees weai protective clothing ami equipment clean change rooms shall be provided, in accordance with I lH(). 141(c) (3). (in) Wlinc employees aie icquircd by this standard to SYNTHETIC VINYL CHLORIDE; I'OI YMI R VINYL CHLORIDE IS A CANCER SUSPE.C I At .INI POLYMER CONTAINS *% BY WEIGHT UNKEAl I) VINYL CIILORIDI *(To be analytically deter mined by maun lac I nun am appropriate value enleied on labels.) (iii) Containers of vinyl chloride shall be labelled , follows: VINYL CHLORIDE. DANGER! EXTREMELY ELAMMAItl I 1IIJUHI) AN GAS UNDER PRESSURE CANCE R SUSPECT AG I N I IIAKMI UL II INIIALI D may polymerize; VIOLEN 11 1 UNDER EIRE CONDI I IONS OR LOSS OR REMOVAL OE IN11IBII OR Keep away from lieal, sparks, and open llame. wash, washing lacilitics shall be provided in accordance Keep container closed. with ij 1010.141(d) (I) and (2) (ii) through (vii). Use with adequate ventilation. (iv) Where employees are required by litis siandaul to Avoid breathing vapor. shower, shower facilities shall be provided in accordance Avoid contact with skin. with 1010.141(d) (3). Keep cylinder out of sun and away fmm heat. 4. Conlamination control. Container should be grounded when hang emptied. (i) Regulated areas, except for outdoor systems, shall Never drop cylinder. be maintained under negative pressure with respect to FIRST AID: If inhaled, remove to liesh air. II u iionrcgulalcd areas. Local cxhaust.vcntilalion may be used breathing give artificial respiration, picletahlv mouth i to satisfy this requirement. Clean tempered makeup air mouth. If breathing is difficult, give oxygon. Call shall ieplace an removed. Exhaust air shall not be dis physician. charged to regulated aieas, nonregulaled areas, or the In case of: external environment unless decontaminated. Eire - Use water spray, dry chemical, m ( <>- (ii) Any equipment, material, or other item taken into Spill or Leak For small spills, evacuate aiea a oi removed I mm a regulated area shall be done so in a permit to evaporate. For large spills or leaks, evacu maimer that does not cause contamination in nonregu- area. Dike or flush to ground and let evaporate. Do i latcd aieas or the external environment. flush to sewer because of explosion ha/aid. 03 (in) Decontamination procedures shall be established 3, Training and indoctrination. and implemented to remove vinyl., chloride from the (i) Each employee, prior to being authou/ed to enu sin laces of materials, equipment and the decontamination regulated area, shall receive a training and mdoclrmat facility. program including, but not necessarily limited to c Signs. Information, and Training (a) The nature of the carcinogenic hazards ol v I Signs. chloride monomer, including local and systemic ioxk (i) Enhances to regulated areas shall be posted with (b) The specific nature of the operation involving s signs bearing lire legend. chloride monomer which could result in exposing; "ibt (?) 1Q7/J hv The Bureau of National Affairs, Inc. ISS 00256 1314 (c) 1 Ik- pm pose lor and application ol' lire medical sinveill.ime pmgram, (I) 'I lie |uiipose lor and application ol' dccnnlumiuulion pi.kI ices and pm poses, (e) I lie puipo.se loi and significance ol ciiicigcncy piai flees and piosedlties. (I) I lie employee's speetlie lole under normal o|ieialine ol emeieeucy conditions'. () Sped lie mloi maiion lo aid llie employee in iccogmiion .uni 11,ilu.iiion ol londiiioiis and siluulioiis wlrieli iim icsiili m ilie ii leasi ol vim 1 chloride monoiuei; (hi I lie piuposc lot and applieaiioir ol specific lirsl aid pioii'dmes and piucliecs: tO A icnevi ol litis xt.mdaid al (lie employee's lirsl li.lining ami iiulocliiiiaitnii progiam and annually tlicreal lei (li) Spnilii emeigcno pioeedmes shall be prcseiibed, and posled. ami employees shall be lamiliaii/ed with 1 heir (Cims. and lelie.usnl m llieii application. (iii) All m.iiciials refiling lo lire pmgram shall be piovided upon letpiesl (o aullion/cd reprcsentalives of the Assislanl Seeielaiy ami the Dnector. I. ! .mironincutal Monitoring amI Recordkeeping (i) 1 miioumeiilal comrnlralious ol vinyl chloride shall he delcimincd Ihmugli lho use of methods lor sampling ami analr ms leeonmiemled hy the Dnecloi or by mellrods ol al leasl equal seusihvily. In) Imployees oi ilieo lepieseiiialivcs shall be pio\uled willi llie oppoi11iu11 v lo observe enviummeiilal momloiiiie aelmiies and shall have access lo llie lesulls. (mi) CompleL and aecuiaie iccoids ol all environmeulal mcasmcmcuis shall be maintained loi al leasl 20 \e,ns In llie unplovci oi .,un.essois llierelo and slrall be piovided upon icquesl lo aulluni/eil icprcscnlalives ol die .Assislanl Seeielaiy or llie Director. V. /li/M/lS I. <tperanons Williin (A) days lire billowing in lot maiion shall be lepoiled m willing lo ihe appropriale Occupational Safety and llealllr Administration (OSIIA) Area Director. OCCUPATIONAL SAFETY & HEALTH REPORTER Any change in such information shall be similaily icportcd within I 5 calondai days of such change. (1) A hiicf desciiption and iu-plaut locution of the aica(s) legulalcd and llie addicss of each regulated aiea, (ii) llie number of employees iu each icgulaied aiea, dining uounal operations, including maintenance activity: (iii) A copy of the Couliol I'lati as developed umlei pyiagiaph 2(a) (ii). (2) Ijmroiiincntal Measurements. On a semi-annual basis die icsulls of measiiiemenls taken al shalegie sampling points, piesenled in siuh a inaimei as lo idenldy achievement ol goals established m the Control I'iaii, shall he tepoiled in wiiiing, lo die apptopnale .OSIIA Aiea Director. (.1) Incidents. Incidents which icsult in (lie iclease of unyl ehhuide monumei into any aiea wheie employees may he polendaily exposed shall be lepoiled in aeeoidauee with tins subpai agrapli. (i) A icpoii of die oceurienec of llie incident ami die fads obtainable at lhat lime including a icpoii on any medical treatment of affected employees shall be made within 24 hours to the appiopiiale OSIIA Aiea Dirccbn. (ii) A wiittcn report shall be filed willi the appiopiiale OSIIA Aiea Director williin 15 calcndai days (lieiealiei and shall include: (a) A specification ol llie amoiini ofmaleii.il lele.ised, Ihe auiounl of lime involved, and an explanation ol llie piocedme used in delermiumg ibis dguie: (lr) A ilescnplioii of llie aiea involved, ami du eslini of known and possible employee exposure and aiea conlaminal ion; (c) A tepoil of any medical licalmcm ol allcded employees, and any medical surveillance pmgiam imple menletl; and (d) An analysis of the cncumslances ol die mculenl, and measures lakcn or to lie laken, with specdic eomplelion dales, to avoid luilbei similai releases. McUust^saseM^^.------------------------ -- (To be provided by N10S11 as soon as possible.) j / OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION LETTER OF INTENT TO INITIATE 'D"V,'C. P' LAN REJ' E>,VCTIOMONW.' PRO CES "S, REA' SONS FOR NON-APPROVAL Mi. t'll.ii les T. (iieene Dneilor ol luduslnal Saleiy (iovcmmcul ol llie Dislncl ol Columbia Minimum Wage and luduslrial Saleiy Board Ol S I ye Slic'd, N.W. W.isluugloii. DC. 20001 Dear Mi. t.ieeue: 1 am enclosing a snmmaiy of the major areas in the Dislncl ol (,'ulumhia I'lan which would require modifica tion ut oidci In mcel llie icquiiemcnl.s of section 18 of the Occupational Saleiy and lleallli Acl of 1070 and the implementing legnlalionv Most, if not all, of llicsc prob lems have been communicated to your stall' on previous occasions and d is our understanding that you have agiecd lo make numerous revisions in llie plan. These include providing criminal penalties as stringent as llmse of llie Federal program for willful violations causing death, unauthorized advance notice and false statements, making provision for formal establishment of abatement periods, and certain technical improvements. However, we conclude that such icvisions do not overcome the limitations of effectiveness icsiiltmg hour enforcement of safely and health standaids basically through criminal penalties. As explained nunc fullv m the enclosed summary, these involve failure ol such a system to piovidc for participation of employees as a mallei of light in llie icvicw process and lack ol die designated agency's control over ilciprelulioi' >'f it"- law and its application in the review process. CUSAROSS 00257 4-5-74 (DLR) FULL TEXT SECTION (No. 67) K.S E -.1 031 LA. EMERGENCY'TEMPORARY STANDARD ON VINYL CHLORIDE (TEXT) . Title 29--Labor 50 ppm, in order to assess In a more rary standard. In a telegram to the As CHAPTER XVII--OCCUPATIONAL SAFETY definitive way whether that level of ex sistant Secretary of Labor, received on AND HEALTH ADMINISTRATION, PARTMENT OF LABOR DE posure produces tumors In animals. Data reported by Torkelson,. Oyen and Rowe or about March 14. 1974, the President of the United Rubber Workers Interna PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANOAROS (American Industrial Hygiene Associa- . tional Union urged the establishment of tion J 22:354-361 (1961)) Indicate that an emergency temporary standard for exposure to VC at concentrations of 60 VC. During the bearing of February 15, Emergency Temporary Standard for ppm failed to Induce tumors in rats, 1974, the Industrial Union Department, Exposure to Vinyl Chloride hamsters, rabbits, and dogs. AFL-CIO, and the United Rubber Work 1. Background. Vinyl chloride (chloroethene). Chemical Abstracts Service The employees of the B. F. Goodrich Chemical Company who died from an ers International Union made a Joint petition for an emergency temporary Registry No. 15016, Is a synthetic chemi giosarcoma of the liver had an average standard for VC (TR 141-143), which cal made by oxychlorination of ethylene or by hydrochlorination of acetylene. It is the parent compound of a series of exposure of approximately 19 years to vinyl chloride, at unknown concentra tions, and variable exposures to other was also Joined by the Oil, Chemical and Atomic Workers International Union (TR 37). At the same hearing, several thermoplastic resin polymem and co polymers which arc widely used for con tainers. wrapping tissues, electrical In volatile chemicals. (TR 93). Some em ployees of Union Carbide Company and Ooodyear Company are also reported in participants urged, on the other hand, a regular rulemaking proceeding as the most suitable for the orderly develop sulation, pipe, conduit and a variety of other products. Vinyl chloride has been made commercially in this country since 1'93!) and present production Is In excess of seven billion pounds per year. Vinyl chloride <VC) Is a gas at am a post-hearing comment from NIOSH ment of relevant information (TR 112 dated March 11, 1974, to have had ex 180). posure to vinyl chloride and to have died The petitions for an emergency tem from angiosarcoma of the llver^ Finally, porary standard specified In detail the autopsies of four deceased employees re contents of the standard requested lt\ vealed that liver angiosarcoma tumors substance, the request Is to Issue a com bient teiniH'i'ature and pressure and Is a chlorinated hydrocarbon which has mod wore histologically indistinguishable from the angiosarcoma tumors observed prehensive fully-developed standard based on the recommendations of the ern to liver toxicity. The present standard sets a celling value of 500 parts per In Professor Mnltonl's experimental nnlmals. It Is concluded therefore, that Standards Advisory Committee on Car cinogens submitted to the Asslstmil fSec million (ppm) <29 CFR 1910.03). On January 22, 1974, the Occupational Safety and Health Administration was Informed by the National Institute for Occupational Safety and Health < NIOSH) that the B. F. Ooodrich Chem ical Company reported that deaths of several of its employees from a rare form of liver cancer may have been occupa tionally related. As a result of this notifi cation, and after consultation with NIOSH and a joint Inspection of the plant by OSHA, NIOSH, and the Ken tucky Department of Labor, a fact-find ing hearing on possible hazards involved with the manufacture and use of both VC and polyvinyl chloride was an nounced on January 30. 1974 <30 FR 3874i. and held on February 15, 1074. 2. Carcinogenicity of VC. Information produced nl the hearing demonstrated that exposure of laboratory animals `mostly Sprarrue-Dawlcy rata) to VC by Inhalation nt and below the current OSHA standard of 500 ppm induced tumors, including angiosarcomas of the liver. Professor Cesare Maltonl, or the Instituto di Oncologta. Bologna, Italy, rel>ortcd on a series of experiments on the effect of exposure of rats, mice, and hamsters to VC at concentrations of 10,000; 6,000; 2,500; 500; 250; and 50 ppm for varying periods of time <TR 43-63). Some of the experiments have been con cluded, and others are still ongoing. The experimental results so far reported are vinyl chloride is carcinogenic for hu mans. We therefore conclude that the present standard for VC should be lowered from a celling of 500 ppm to a celling of 50 ppm for the following reasons: (a) m light of the evidence referred to above Including the Maltonl experi ments demonstrating that VC Is carcino genic in animals at 250 ppm. we conclude that VC must be considered carcino genic in man at the same level; (b) Although Professor Maltonl did not Induce tumors In his experimental animals at an exposure concentration of 50 ppm, these data do not support the concept that occupational exposure of employees to concentrations of 50 ppm throughout their working lifetime would be without detrimental health effects; (c) The Question whether safe levels of exposure to carcinogens exist for hu mans and, if so, what such levels would be, Is the subject of continuing scientific deliberation. In the case of VC, Profes sor Maltonl did not observe tumors in his animals at exposure concentrations of 50 ppm. In addition, Torkelson, Oycn, and Rowe found that exposure to con centrations of 50 ppm of VC failed to in duce tumors in rats, hamsters, rabbits, and dogs. Accordingly, there is insuf ficient evidence at this time to conclude that VC at concentrations of 50 ppm or below poses a grave danger to humans. (d) The emergency temporary stand ard adopted represents a substantial re retary of Labor on or about August 27, 1973. The recommendations arc (ar ranging, and cover special categories of operations, signs and labels, medical sur veillance, reporting, etc., Including a per mit system for the use of a carcinogen. We agree that ah emergency tempo rary standard Is necessary; we cannot say on the basis of the information developed so far that a comprehensive standard, such as the one requested, ts either neces sary or even desirable. It has been de cided to promulgate a standard contain ing only those essential provisions which are deemed necessary to provide protec tion to employees from grave danger until a regular rulemaking proceeding in accordance with sections 8 (b> and <c> of the Act can be concluded. The rea sons for a decision to establish n celling value of BO ppm have already been stated. A decision on other possible, ap propriate provisions is best made after consideration of all relevant data and views that Interested persons may sub mit during the proceeding soon to be initiated. With respect to arguments in opposi tion to Issuance of an emergency tem porary standard, the concern and efforts of several companies participating at the hearing for the protection of their em ployees are recognized. It may also be that some employers In some plants have fully complied with the interim conti olr, recommended by NIOSH on January 30, 1974. There is, however, xeoson to believe that tumors have been observed in duction in the permissible level of expo that employees are currently being ex groups of animals exposed to VC at con centrations as low as 250 ppm. No tumors sure and, in our practical judgment, is the lowest level that can be complied posed to VC at concentrations well above 50 ppm. This was.asserted several times have been observed in the group of ani mals exposed to VC at a concentration with immediately; and <e) This standard will be in effect for at the hearing, and not seriously ques tioned. Moreover, a report, dated March of 00 ppm. It also appears so far that a period of no longer than six months, 1974, of a survey by the staff of the Office the total number of tumors, as well as the numbers of angiosarcomas of the durlng'whlch time the whole question of possible safe exposure of humans to VC of Standards Development. OSHA, of several facilities manufacturing VC an.i liver, decrease as the concentrations of will be reconsidered more fully and in polyvinyl chloride revealed concentra VC are reduced to 250 ppm. Finally, the light of more Information, Including tions for some Job classifications as high another experiment by Professor Mal experiments which are uuder way at this as 229 ppm. Therefore, a regulation 1` tonl Is underway Involving the exposure time (TR 47, 49, 71-74). considered necessary to provide, lmmedl of 300 animals to VC at concentrations of 3. Petitions /or an emergency tempo ately, adeqt Published hy THE BtlKEAU OK NATIONAL AFFAIRS/ INC.. WASHINGTON CUSAROSS 00258 E -.2 (No. 67) FULL TEXT SECTION (DLR) 4-5-74 ^osed to VC. Also, the eight-hour, ttme- Secretary of Labor's Order No. 12-71 (36 (4) Employee observation, of monitor wetghted average standard suggested by FR 8754), 29 CFR Part 1910 Is amended ing^ Employees working la an area or I several participants at the hearing (see, by adding thereto a new $ 1910.93q to operation whose ambient air fs moni for instance, Tft 178), has been rejected. read as set forth below. In addition, pur tored, or their representatives, shall be The March 1974 report o the survey re suant to section 4(b) (2) of the Act (84 given a reasonable opportunity to observe vealed that several kinds of work or op Stat. 1692; (29 U5.C. 653)), the stand the personnel monitoring required by erations are of short duration. Loading ard in the new f 1910.93q Is determined this section. or unloading of a tank car may require to be more effective than the corre (5> Recordkeeping. The results of ail approximately 16 minutes. The cleaning sponding standards now In Subpnrt B of monitoring shall be recorded in writing of a reactor may require approximately Part 1910, in Part* 1916, 1916, 1917, 1918. The records shall be retained for at least half an hour. An eight-hour, time- and 1926 of title 29, Code of Federal Reg 5 years and shall be made available for weighted average standard would permit ulations. and In Part 50-204 of Title 41 of Inspection and copying by representa exposure to VC at concentrations of 400 the Code of Federal Regulations, There tives of the Assistant Secretary of Labor ppm foe one hour. Such upward excur fore, these corresponding standards are for Occupational Safety and Health sions, several times the 60 ppm level, can superseded by the new standard in and the Director of the National Insti not be permitted to occur. I 1910,93q. tute for Occupational Safety and Health 4. The standard. The standard set out 1. In 29 CFR Part 1910, i 1910.93 Is (NIOSH). below contains only the requirements amended by deleting from Table G-l the (6) Employee gcces*. Each employee deemed necessary to provide protection line:........... .... Vinyl chloride * 600 and former employee shall have access to before the conclusion of the rulemaking * 1300". such records of the results of monitoring proceeding to be commenced shortly. 2. Part 1910 of Title 29 of the Code required by this section as will indicate Uecause exposure to VC Is' hazardous, of Federal Regulations is amended by his own exposure to airborne concentra and because such exposure can occur In adding thereto a new i 1910.93q to read tions of vinyl chloride.. the processes of synthesizing or polym erizing of VC or In the handling of VC polymers or copolymers which contain absorbed VC. this standard applies to all as follows: 8 l*M0.93q Vinyl chloride. (a) Scope and application. (1) Tills (7) Employee notification. Each em ployer shall promptly notify any em ployee who has been or Is being exposed to vinyl chloride In concentrations in ex such processes and to the handling, re section applies to any area or operation cess of 50 ppm. and shall,inform him of acting, manufacturing, processing, re In which vinyl chloride (chloroothenc >. the corrective action being taken. leasing, repackaging, or storage of any of these materials, lire monitoring require Chemical Abstracts Service Registry Number 75015, is manufactured, reacted, (d) Compliance. (1) Whenever any monitoring sample reveals vinyl chloride ments serve two purposes, to trigger into handled, processed, released, repacked, at a concentration in excess of 60 ppm. operation a compliance program and to or stored, or whenever any accident, such as rup check the effectiveness of the program. (2) This section does not apply to the ture of equipment or spillage, Indicates Also, engineering controls are favored for compliance, and respirators are intended to provide protection until such controls handling, storage, or other use of vinyl chloride polymers and copolymers In the form of fabricated products. the likelihood of a greater than usual release of vinyl chloride into the ambient air, all employees exposed to such con can be installed or in cases where suoh <b> Permissible exposure. The occupa centrations shall be withdrawn to a safe controls arc not feasible. tional environment shall be controlled so area and shall not be permitted to re Accordingly, by reason of the foregoing that no employee Is exposed to vinyl enter the work area unless they wear and on Uie basis of the record of Uie chloride at a concentration In excess either Type C continuous flow or pres hearing of February 15, 1974, with ex hibits, t lie written submissions received before the hearing pursuant to the notice of 50 parts per million (ppm) (127.0 mg cum). (c> Monitoring--(1) Initial monitor sure demand air supplied respirators or self-contained breathing apparatus. (2) Work which may reasonably be of the hearing, the post-heunng written ing. As soon as possible but not later than expected to release vinyl chloride in con - submissions by the participants at the April 22, 1974, every employer of an em centratlons in excess of 60 ppm, such as hearing, the March 1974 report of a fact- ployee working In an area or operation In repair, maintenance or cleaning of re finding survey recommendations received which vinyl chjorlde Is manufactured, re actors or other equipment containing from NIOSH, and the other data referred to herein, it is found (1) that VC at con acted, handled, processed, released, re packed, or stored shall begin monitoring vinyl chloride, shall be accomplished only by employees wearing Type C continuous centrations in excess of 60 ppm Is physi the ambient air of the area to determine flow or pressure demand air supplied res cally harmful and carcinogenic; (2) that whether It contains vinyl chloride In con pirators or self-contained breathing ap exposure to VC at concentrations In ex cess of a concentrat ion of SO ppm poses a grave danger to employees; <3> that em centrations in excess of SO ppm. (2) Frequency. Monitoring of a suffi cient number of employees so that a paratus. (3) In any case covered by para graphs (d)(1) or (d)(2) of this section, ployees are presently exposed to VC at concentrations In excess of SO pptn; and <4 > that the emergency temporary stand ard set out U'low is necessary to provide immediate protection to employees from such danger. Pursuant to section 6(c) of the Occu pational Safety and Health Act of 1970. a proceeding will commence shortly In accordance with section 8(b) of the Act, in which the emergency temporary standard will serve as a proposed rule, together with other subsidiary rules. As soon as possible a draft environmental impact statement will be filed with the President's Council on Environmental Quality, and copies will be provided to other appropriate Federal agencies for I. their comments, I Pursuant to sections 6(c) and 8(c) (3) ' of the Williams-Steiger Occupational Safety and Health Act of 1970 (84 Stat. representative sample of exposures to vinyl chloride may be determined shall be accomplished not less frequently than weekly untU all results for three consecu tive weeks are at or below 50 ppm. There after. monitoring shall be conducted not less frequently than monthly so long as the concentrations of vinyl chloride do not exceed 50 ppm. If a monitoring sam ple reveals vinyl chloride in concentra tions In excess of 50 ppm, weekly moni toring shall be resumed until all results for three consecutive weeks are at or be low 50 ppm. (3) Method of monitoring. Personnel monitoring shall be accomplished by col lecting samples by suitable devices worn by the employee. The samples shall be analyzed by gas chromatography or by any.other method which is of equivalent sensitivity. The analytical procedure shall be sensitive to 5 ppm of vinyl chlo ride in air with an accuracy of 20 per cent for a ten minute air sample. In addition to providing the required respirators, the employer shall examine and analyze the source of the excessive concentrations of vinyl chloride in order to determine feasible engineering or op erational controls appropriate to reduce the airborne concentrations to the permissable level. Such controls shall be Implemented as quickly as possible. (4) Periodic tests shall be conducted for equipment leaks and for emissions of vinyl chloride which may result from work practices. 3.In 29 CFR Part 1910. I 1910 19 is revised to read as follows: g 1910-19 Special provisions for air con taminants. (a) Asbestos dust. Section 1910.93a shall apply to the exposure of every em ployee to asbestos dust in every employ ment and place of employment covered by 1 1910.12, { 191043. 1 1910 14. S 1910.15, or f 1910.16, in lieu of any du- 1596, 1699; (29 UJ9.C. 653, 057)), and CUSAROSS 00259 Published by THE DUREAU OF NATIONAL AFFAIRS, INC., WASHINGTON, D.C. 20037 4-5-74 (DLR) FULL TEXT SECTION (No. 67) E - 3 i ferent standard on exposure to asbestos dust which would otherwise be appli cable by virtue of any of those sections. (b) Vinyl chloride. Section 1910.03a sKall apply to the exposure of every em ployee to vinyl chloride In every employ ment and place of employment covered t>y 11010.13, I 1010.13, 11910.14, i 1010.15, or 11910.10, In lieu of any dif ferent standard on exposure to vinyl chloride which would otherwise toe ap plicable by virtue of any of those sec tions. Effective date. These amendments shall become effective on April 5, 1974. (Beet. 4, 6, and 8. 84 Stat. 1603. 1806, 1800 (30 TJ.8.C. 883, 656, 667); Secretary of lAbor'e Order No. 13-71.36 FR *764.) Signed at Washington, DC., this 2d day of April 1074. John Sirnotii, Assistant Secretary o/ Labor. [FR DOC.74-7800 Filed 4-4-74,8:46 tm] -- End of Text --- End of Section E CUSARSS 00260 I'ulili-Jied by THE RUREAU OF NATIONAL AFFAIRS, INC., WASHINGTON. D.C. 200.17 IMA REPORT April, 1974 n. t NATIONWIDE SURVEILLANCE OF ANGIOSARCOMA OF THE LIVER IN U.S. /------------------------------------------------------------------------------------------------------------ Physicians who have patients under their care with a diagnosis of angiosarcoma of the liv r, c who have encountered such cases in their practice over the past 10 years, are urged to conta< the U.S. Center for Disease Control in Atlanta. Information concerning all such cases, re gardless of assumed etiology, should be mailed to Center for Disease Control, Bldg. 1, Room 520, Atlanta, Ga. 30333, or telephoned to (404) 633-3311, ext. 3961. Such information will become a part of a national surveillance registry for cases of angiosarco of the liver in the United States which was recently established by the National Institute for Occupational Safety and Health and the Disease Center's Bureau of Epidemiology in response the recent discovery of the possible relationship of this exceedingly rare tumor to vinyl chlori exposure. Since January of this year when The B.F. Goodrich Chemical Company reported tf first suspicions that vinyl chloride might be implicated in four cases of angiosarcoma of the li\ that occurred among employees who had spent many years in vinyl chloride operations, three ditlonal cases have been identified in workers at this plant, and single cases have been repor at two other plants. All four of the initial patients had worked in various phases of the vinyl chloride polymeriza tion process for at least 14 years before diagnosis, and each showed evidence of coexisting hepatic fibrosis in the absence of heavy alcohol intake, prior hepatitis, or exposure to hepa- s/ totoxic agents outside the work environment. In particular, there was no evidence of expo sure to thorium dioxide or arsenic, two chemicals previously implicated as causes of this tumor in man. Epidemiologic studies are underway to define more precisely this apparent relation ship between hepatic angiosarcoma and exposure to vinyl chloride. The national surveillance registry is a vital part of this effort, both as a measure of past and present incidence in the United States, and as a means by which to gauge what proportion of cases may indeed be re lated to vinyl chloride. Full participation by physicians in this surveillance effort Is urgently solicited by Marcus Key, M.D., NlOSH Director, and Clark W. Heath, jr., M.D., Chief of the Cancer and Birth Defects Division of the Bureau of Epidemiology. CUSARO.SS 00261 *7 Health Hazards EASTMAN KODAK SUBSIDIARY ISSUES PRELIMINARY REPORT ON MBK EXPOSURE Exposure of rats and guinea pigs to high concentrations of methyl butyl ketone (MBK) through inhalation and dermal contact produced serious health effects, a prehminuiy study by Last man Chemical Products, Inc., in dicated. As a resull of tlie study, which was foiwarded volun tarily by Eastman CIicuuluIs to the National Institute tor Occupational Satcly ami Health, and to its 2,000 customcis, some action by NIOSII can be expected within the next two weeks, OSIIR was told, hxposuto of woikers to MBK has been used to link peripheral ncuiopalhy and polyneuritis suffered by workers at Columbus Coated Fabrics, Inc., which has formed the basis of an extensive dispute between labor and management at the firm's Columbus, Ohio, plant (Current Report, March 7, p. 1251). The studies involved exposuic of concentrations of MBK, methyl ethyl ketone (MLK), and methyl isobutyl Ketone (MIBK) to dogs, monkeys, and rats. Inhalation 'rates ranged from 1,300 to 2,000 ppm for six hours a day, five days a week during a four-month period, OS1 II< was told. Although results on the dogs and monkeys were inconclusive, all six rats in the tests showed changes inthe nerves characteristic of peripheral neuropathy. The rats underwent 61 exposures at levels many times higher Ilian the occupational level of 100 ppm. In addition the rats all had signs of lund leg footdrop, the study found. Exposure of the animals lo MLK and MIBK did not produce conclusive results, according to the study. Dermal Exposure Guinea pigs were treated with skin applications of MBK during a four-month pcnod. For the first four weeks 802 \mig were applied to the animals once a day, while for the d 14 weeks, they were given 1604 mig Iwicc a day. At E end of the study the animals were found lo have a od concentration of MBK equal to 10 percent of the original application. Fastman Chemicals issued a letter on March I to its 2,000 customers outlining the results of the study and recommending procedures to be followed until upper levels of occupational exposure to MBK^ can be estab lished. Among the recommendations were the following steps: Contact of the skin and eyes with MBK should be avoided by use of protective clothing and protective eye equipment. In conditions where spills of MBK arc possible, respiratory equipment for personnel who might be ex posed should he utilized. Where there is contact between MBK and the skin, the skin should he washed immediately with water. Exhaust ventilation should be used to keep exposure levels to MBK below 100 ppm. CUSAROSS 00262 U. S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH CINCINNATI, OHIO 45202 HEALTH HAZARD EVALUATION DETERMINATION REPORT 72-58 CITY FOODS SEATTLE, WASHINGTON SEPTEMBER 1973 TOXICITY DETERMINATION In response to six requests for Health Hazard Evaluations from retail meat wrapping employees in and and around Seattle, Washington, regarding exposure to the thermal decomposition products of poly vinyl chloride (PVC) meat packaging film, a limited study of retail meat wrappers was undertaken. Although the data presented in this report did not result from direct evaluation of the work environ ment at the City Foods, Seattle, Washington, the findings of this study are generally applicable to retail meat wrapping operations using PVC meat packaging films. It has been determined that air contaminants generated by the thermal cutting of polyvinyl chloride (PVC) packaging films in conjunction with the wrapping of meat are potentially toxic to some meat wrapping employees. This determination is based upon medical evidence compiled during a limited study of meat wrappers in the United States. This study involved a review of the perti nent scientific literature, consultation with researchers in this area of investigation, the collection of medical histories, clinical observations at the worksite, pulmonary function testing of meat wrappers, and consideration of wrapping procedures, equipment, and meat wrapping environmental conditions. Evidence suggests that a sizeable percentage of meat wrappers suffer from mild symptoms to include eye, nose, and throat irri tation. A portion of these affected meat wrappers who have an underlying predisposition to respiratory difficulties resulting from a variety of conditions (tobacco abuse, asthma, emphysema, and other serious respiratory diseases) experience more serious respiratory problems. These can include shortness of breath, difficulty in breathing, coughing, and general physical distress. This study has not established whether or not presently heaUhy <i- meat wrappers may develop respiratory difficulties after prolongs!* exposures to contaminants frgm thermal decomposition.^ PVC r packaging films. Although substances in the meat wrapping environment other than those associated with PVC films may be responsible for the pre viously stated clinical manifestations, the available evidence strongly implies that the air contamination from thermal cutting of PVC packaging film is the causative agent. As yet, the^athophysiologic mechanism for this malady is not clearly understood. ^). s i ! i i { j I CUSAROSS 00263 Page 2 - Health Hazard Evaluation Determination 72-58 Based on present experience with this particular problem, it is recommended that the following practices be instituted: 1. Pre-employment physical examinations, including chest x-rays and pulmonary function tests be performed on all individuals entering the meat wrapping industry. (Individuals who are found to hove severely compromised pulmonary function or who exhibit strong predisposition to Dulmonary disorders should not enter the meat wrapping profession.) 2. Meat wrapping machinery should be clean and well maintained. Machines with controlled low temperature cut-off wires are to be preferred. (There is need for further study with regard to controlling contamination at its source via new cutting mechanisms or local exhaust ventilation, etc.) 3. Meat wrapping should be .^conducted in well ventilated surroundings. II. DISTRIBUTION AND AVAILABILITY OF THE DETERMINATION REPORT Copies of this Determination Report are available upon request from the Hazard Evaluation Services Branch, NIOSH, U.S. Post Office Building, Room 508, 5th and Walnut Streets, Cincinnati, Ohio 45202. Copies have been sent to: a) City Foods, Seattle, Washington b) Authorized representative of employees c) U. S. Department of Labor - Region X d) NIOSH - Region X e) Washington State Department of Labor and Industries For the purposes of informing the 1-3 affected meat wrappers the employer will promptly "post" the Determination Report in a prominent places near where affected eniployeas/work for a period of 30 calendar days. III. INTRODUCTION , ,, Section 20(a)(6) of the Occupational Safety and Health Act of 1970, 29 U.S.C. 669 (a)(6), authorizes the Secretary of Health, Education, and Welfare, following written request by any employe!? or authorized representative of employees, to determine whether any .substance normally found in the place of employment has potentially toxic effects in such concentrations as used or found; The National Institute for Occupational Safety and Health (NIOSH) received such a request from an authorized representative of the meat wrapping employees at the City Foodsv Seattle, Washington, CUSAROSS 00264 Page 3 - Health Hazard Evaluation Determination as well as from five other stores in Seattle, Washington area regarding employee exposures to the potentially toxic substances emitted from thermal decomposition of polyvinyl (PVC) packaging films in use in the meat department. One to three meat wrap ping employees are employed in each of these stores and are subsequently exposed to the substances in question. IV. HEALTH HAZARD EVALUATION A. ' Description of Process - Conditions of Use Although several types of meat wrapping machines were observed during the course of this study, most machines incorporated the basic features of the "typical' hand wrapping machine shown in Figure 1. Wrapping meat involves: (1) pulling out a desired length of film, (2) wrapping the film around a tray or cut of meat, (3) severing the film from the supply roll using the hot wire cut-off, (4) folding the film ends under the package, and (5) sealing the folded ends under the package by touching the package to the heated pad. Air contaminants generated by the hot wire cutting of PVC packaging films and their alleged toxic effects on meat wrapping employees constitute the subject of this health hazard evaluation. There are approximately 75,000 meat wrapping employees in the United States, according to union and industry estimates. B. Study Background and Design Polyvinyl chloride and wrapping film is made from pure PVC resin and a variety of additives. All additives must be approved by the federal Food and Drug Adminstration for use in meat packaging ma terials. These additives include plasticizers, stabilizers, anti fog agents, lubricants, and colorants. Plasticizers (dioctyl adipate di-2-ethyl hexyl adipate, and epoxidized soya.or soybean oil) can comprise up to 30% of the film. Stabilizers (calcium-zinc stearate) antifog agents (e.g., polyoxyethylene derivatives of sorbitan monooleate), lubricants (e.g., stearic acid), and colorants together makeup roughly 2-6% of the film. Several investigators have attempted to identify and quantitate air contaminants generated t>y the hot wire cutting oft PVC film in the meat wrapping environment. Early field measurements for hydrogen chloride (HC1) detected trace amounts (less than l ppm) in the vicinity of meat wrapping operations.3 A later laboratory study of air contaminants from hot wire cutting of PVC film confirmed the presence of HC1 and related its rate of generation together with the rate of generation of particulate to the operating temperature of the hot wire.3 As would be expected, the production of`both HC1 and airborne particulate increase with increasing wire temperature. r-' 4 * CUSAROSS 00265 Page 4 - Health Hazard Evaluation Determination FIGURE 1: Typical Hand-Wrapping Machine rr. s Manufacturers of Wrapping Equipment: Automatic^ Semi-Automatic, and Hand Wrapping ,i Cleveland-Petroit Corporation,'Clamco Division J. B. Dove and Sons, Incorporated v Heat Sealing Equipment Manufacturing Company The Hobart Manufacturing Company Package Machinery Company Reliance Electric Company, Toledo Scales and Systems CUSAROSS 00266 /f. t Page 5 - Health Hazard Evaluation Determination To date, three researchers have found the film plasticizer to be the predominant contaminant generated by the thermal decomposition of PVC meat wrapping film. "5 The oral toxicity of di-2-ethyl hexyl adipate, as determined by animal experimentation, is relatively low. However, no data are currently available regarding the In halation toxicity of di-2-ethyl hexyl adipate. It Is Interesting to note that one researcher, Bovee, et al. identified the plasticizer to-be diisooctyl adipate while the other two (Van Houten and Jaeger) found di-2-ethyl hexyl adipate. Diisooctyl adipate has exactly the same molecular weight as di-2-ethyl hexyl adipate and possesses very similar physical properties. Hydrogen chloride is possibly the second most important degradation product. HC1 can be detected at concentrations of 1-5 ppm and is disagreeable at concentrations of 5-10 ppm. Other film degradation products have been identified, but are present in small quantities when compared to the film plasticizer. These other materials include chlorinated hydrocarbons and breakdown products of film additives. Workplace concentrations of PVC film decomposition products are difficult to measure. As previously, stated, HC1 has been found in very low concentrations in the meat wrapping environment. La boratory experiments by Van Houten et al. suggest that airborne concentrations of HC1 in the plume of "smoke" directly over the hot wire can reach 2 ppm. These measurements were made during "artificially severe operating conditions," which would rarely occur during actual meat wrapping. (It should also be noted that an employee's exposure would be to a significantly lower concentra tion than that found in the plume close to the wire. In the same study plasticizer concentrations in the plume were found as high as 13 mg/M3. Again, this value was found during artificially severe operating conditions. Clinical complaints allegedly resulting from exposure to air contaminants from PVC meat wrapping film were first referenced in an unpublished study conducted by NIOSH's predecessor the Bureau of Occupational Safety and Health.2 According to that investigation, state health officials in Virginia became involved with complaints from meat wrappers in the summer of 1969. Since that time complaints have come in by Tetter and telephone from several cities across the Nation. Due to the informal nature of most of the reports, it is difficult to. accurately estimate the true number of individuals involved. However, a small group of medical investigators scattered throughout the Nation have re ported approximately 50-75 cases of pronounced clinical symptojns. -i : H-' I A CUSAROSS 00267 Page 6 - Health Hazard Evaluation Determination Subjective estimates from union officials, university investigators, medical professionals, and meat wrappers suggest that a large number of meat wrappers are less seriously affected. To better delineate the clinical manifestations of exposure to contaminants from PVC film decomposition a preliminary survey of meat wrapping operations was made. Five retail stores in and around Seattle, Washington were visited during August 7-9, 1972. Meat wrapping operations were observed in each retail store and eighteen meat wrappers with varied work experience with PVC films were inter viewed. Each worker was questioned in an attempt to elicit symptoms of upper respiratory tract irritation, irritation of the eyes, nose, and throat, and occupational dermatoses. Spirometrtc measurements were obtained from thirteen of the meat wrappers. At the completion of this preliminary survey it was clear that a more detailed scientific study would be necessary to elucidate the full ramifications of the potential health problems associated with the use of PVC films. The assistance of the Amalgamated Meat Cutters and Butcher Workmen of North America was solicited to facilitate the location of metropolitan areas where sizeable numbers of meat wrappers were allegedly being adversely affected by air con taminants from PVC films. Following a nationwide search, the City of Louisville, Kentucky was selected as a site fof further investi gatory research. A research protocol was developed under the guidance of pulmonary specialists from the NIOSH Appalachian Laboratory of Occupational Respiratory Diseases. The protocol called for the administration of a health questionnaire and the conduction of pulmonary function testing on meat wrappers and suitable controls. The orientation of the questionnaire and the subsequent interview with a NIOSH physician placed emphasis on occupationally related health problems, especially respiratory health problems. On January 22, 1973, in Louisville, Kentucky, seventeen meat wrappers and twenty non-meat wrappers (office personnel serving as controls) completed medical questionnaires, and' participated in pre- and post-workshift pulmonary function testing. Technical problems regarding environmental sampling prevented evaluation of employee exposures on ifhe efty^of testing. As observed in number of retail establts^ents*-meat v/rappe'Ps* exposures to } contaminants from hot wire cutting of PV6 meat packaging film1 are intermittent and highly variable* To be useful in inter preting employee symptom** breathing zone air samples would have to reflect both average and siiort term exposures. Although these contaminants have been measured in undiluted: form near the source of generation^, there is at present no suitable method- of sufficient sensitivity to measure variable breathing zone concentrations. . a' . .. "t ,.v .. .-S - < CUSAROSS 00268 Page 7 - Health Hazard Evaluation Determination C. Evaluation Methods 1. Medical Questionnaire The medical questionnaire consisted of twenty-six sets of questions. Its purpose as to gather pertinent information concerning an in dividual 's past medical history, smoking history, past occupational exposures, current respiratory status and adverse effects allegedly arising from exposure to air contaminants from PVC films. 2. Pulmonary Function Testing Each pulmonary function test required the employee to make three forced expiratory volume practice maneuvers after which three forced expiratory volume maneuvers (reproducible within 5%) were recorded as flow volume loops. A waterless, high fidelity spirometer equipped with an air temperature probe was used. The flow volume loops were displayed on a storage oscilloscope and recorded on magnetic tape. A photograph of each oscilloscope display was taken for backup. Computer analysis of flow volume loops provided the following parameters forced expiratory volume in one second (FEVl), and flow rates at 25,50,75 and 90 per cent of forced vital capacity (FVC). D. Evaluation Results 1. Preliminary Survey (Seattle, Washington and vicinity) Sixteen of the eighteen meat wrappers interviewed in the preliminary survey were known to have suffered ill effects from air contaminants from PVC films. Only two workers were free of any clinical symp tomatology. Eight had similar case histories and admitted ex periencing varying degrees of sneezing, rhinorrhea, and eye ir ritation. Most individuals gave a like story that the-ill effects came on from one to three hours after the commencement of meat' wrapping in the morning. The workers stated that as the workday progressed the prodromal manifestations increased in intensity. The sneezing, rhinorrhea, and throat and eye irritation would abate in the evening hours and would be non-existent during week ends and vacations. , Five workers experienced more severe clinical symptomatology necessitating physician intervention and, on occasion, hospitali zation. These individuals seemed toi suffer with "occupational brochiolitis." They suffered at times with severe dyspnea, productive cough, and nasal congestion. Orwet of these symptoms was from one-half to two and one-half hours after commencement of work. These ill effects led to increased absenteeism. AH were on one form of medication or another. This group a>so stated that a period of several days away from the meat Wrapping environment was raquiwed for Jjhem to feel like their normal selves. * ` '! i v '** CUSAROSS 00269 *, .i Page 8 - Health Hazard Evaluation Determination Pour of these workers had fifteen or more pack-years of cigarette smoking behind them. Three meat wrappers had pre-existing susceptibility to upper respiratory symptomatology caused by severe disease processes (rheumatic fever, chronic obstructive pulmonary disease, and lung abscess). 2. Medical Questionnaires (Louisville Study) Seventeen meat wrappers and a control population of twenty individuals completed the questionnaire. None of the controls re ported any adverse clinical symptomatology associated with their particular form of employment. The majority of the controls worked as clerks in retail grocery stores. As a group the seventeen meat wrappers averaged nine years and three months of experience in the meat wrapping profession. Fortyfive per cent of these meat wrappers complained of irritation from film contaminants v/hich resulted in watering and itching eyes. Thirty per cent of the wrappers complained of burning or dryness of the throat. Three wrappers (18/0 stated that they experienced "painful breathing" and shortness of breath while working with PVC meat wrap. It is important to note that these same three individuals had a history of allergies, were on medication and were under physician care. 3. Pulmonary Function Testing (Louisville Study) All pulmonary function data were analyzed by bio-statisticians at the NIOSH Appalachian l.aboratory for Respiratory Diseases. The data can be summarized by examining the following statistical tests: Note: df = degrees of freedom (number of employees tested minus one) P = probability that a difference occurred by chance alone. The "student t test" was used to, determine whether there were significant differences between groups of individuals with respect to changes in FEV-j's and.. FVC's. To be significant, a difference between groups would have a probability of occurring by chance of less than 5% or P less than 0.05. CUSAROSS 00270 Wr - K8 Page 9 - Health Hazard Evaluation Determination Test No. 1 - When all exposed (meat wrappers) were compared with all non-exposed (controls) with respect to any differences between pre- and post-workshift values of FEVi and FVC, there was no significant difference at the 95% confidence level (i.e. P less than 0.05). TFEVi (35df) = -0.35 Trvc (35df) * -0.42 P = 0.73 P = 0.67 Test No. 2 - When exposed smokers were compared with non-exposed smokers, there was no significant difference. iFEVi (ITdf) = 0.22 'FVC (lldf) = 0.31 P = 0.83 P = 0.76 Test No. 3 - When exposed non-smokers were compared with non-exposed non-smokers there was no significant difference. TFEVi (22df) = 0.55 tFVC (22df) = 0.11 P = 0.59 P = 0.90 Test No. 4 - Test No. 1 was repeated with respect to peak flow and flow at 25,60,75 and 90% of FVC. There was a significant difference for F90. tPF (35df) * 0.47 JF25 (35df) = 0.38 tF50 (35df) = 0.01 tF75 (35df) = 0.11 tF90 (35df) = 2.39 P 0.64 P = 0.71 P = 0.99 P = 0.91 P = 0.02 Test No. 5 - Test No. 2 was repeated with respect to the preceding parameters and there was a significant difference for F50. tPF TF25 tF50 tF75 tF90 (lldf) = 0.08 (lldf) = 1.36 (lldf) = 2.31 (lldf) s 0,88 (lldf) = 0.54 P = 0.94 P * 0.20 P = 0.04 P 0.40 P = 0.60 Test No. 6 - Test No. 3 was repeated with respect to the preceding parameters and there were significant differences for F75 and F90. TPF tF25 TF50 TF75 tF90 (22df) = 1.14 (22df) * 0.98 (22df) = 1.61 (22df) = 2.26 (2?df) = 2.87 P * 0.27 P = 0.34 P = 0.12 P ** 0.03 P = 0.01 CUSAROSS 0027 i Page 10 - Health Hazard Evaluation Determination In summary, pulmonary function tests of this small, randomly selected population of meat wrappers revealed no gross pulmonary effects in comparison to a control population after one workshift of meat wrapping. Furthermore, it must he stated that this exposed study group was of general good health and free of serious symptomatology. E. Discussion A study of meat wrapping employees is beset by various intrinsic problems from the onset. These include the following: a) Low density dispersal of meat wrappers in any geographic area. b) No more than two or three meat wrappers employed at any typical retail store. c) Meat wrapping work environments, although similar, are not strictly uniform. Differences can exist in packaging equip ment (i.e., operating parameters), type of wrapping material ambient environmental conditions (temperature, humidity), general ventilation provisionsy/ork practices, and volume of meat wrapping performed. d) Work shifts for meat wrapping employees are highly variable. e) There is a lack of suitable sampling and analytical methodology for the evaluation of employee exposures to PVC film decomposition products encountered in retail meat wrapping. At present, methods are not sensitive enough to characterize intermittent exposures or variable constant exposure via breathing zone sampling techniques. The above problems interrupted the completion of this preliminary controlled scientific study. At this point, a limited amount of data have been compiled for a population of basically healthy meat wrappers. There remains the necessity to study a sizeable population of seriously affected meat wrappers. It is felt that such a pop ulation exists based upon scattered reports of clinical symptomatology from various medical investigators throughout the Nation. REFERENCES 1. Vandervort, Robert - Personal Communication by Letter with Major Film Manufacturers, 1970. 2. Vandervort, R. "Polyvinyl Chloride Meat Wrapping Film Study," unpublished USPHS, BOSh, D0IDC, Technical Assistance Report, Cincinnati, Ohio (1971). CUSAROSS 0027 Page 11 - Health Hazard Evaluation Determination 3. Van Houten, R., A. L. Cudworth, C.H. Irvine. Evaluation and Reduction of Air Contaminants Produced by Thermo Cutting and Sealing of PVC Packaging Film. Liberty Mutual Insurance Company, Hopkinton, Mass. (Unpublished). 4. Bovee, H.H., L.E. Monteith, and R.M. Orheim. Thermal Decomposition of Meat Wrapping Film. Department of Environmental Health, School of Public Health and Community Medicine, University of Washington. (Unpublished). 5. Vandervort, Robert - Personal Communication by telephone with Dr. Rudolph Jaeger, Associate Professor of Toxicology at Harvard University School of Public Health. 6. Patty, F.A. Industrial Hygiene and Toxicology, Vol. II, John Wiley & Sons, 1963. AUTHORSHIP AND ACKNOWLEDGEMENTS Report Prepared By: Phillip L. Polakoff, M.D. Medical Officer Robert Vandervort Industrial Hygienist Originating Office: Jerome P. Flesch, Chief Hazard Evaluation Services Branch Acknowledgements N. Leroy Lapp, M.D., ALFORD, Morgantown, West Virginia Arvin G. Apol, Regional Industrial Hygienist, Region X, Seattle, Washingtoh Bobby J. Gunter, Ph.D., Regional Industrial Hygieniest, Region VIII, Denver, Colorado Richard Gais, Pulmonary Technician, ALFORD, Morgantown, West Virginia CUSAROSS 00273 r, Case Reports Occupational Acroosteolysis Saul S. Markowitz. MD: Charles J. McDonald, MDi William Fethiere, MD; and Marvin S. Kenner, MD. Providence, Rl Occupational acroosteolysis Is an un usual disease In which affected persons have sclerodermoid-llke lesions of the skin, conditions similar to Raynaud's phenomenon, and asymptomatic, bony defects of the extremities. To our knowl edge, the disease Is confined solely to workers In the plastics Industry, specifi cally those engaged in the production of polyvinyl chloride from vinyl chloride. The Incidence of the disease Is unknown but is thought to occur in 3% or less of workers. t is indeed impressive to note that I although the industrial process of polymerization of polyvinyl chloride (a solid plastic material) from vinyl chloride (a gas) has been widely used in the plastics industry throughout jthe world for three decades or more, disease, occupational acroosteolywhich is apparently related to this process, did not emerge as a new clinical entity until 1963.' It is even more impressive to us as dermatologists to note that although the initial compliants or manifesta tions of the disease and most of the i debility related to it are of a derma tologic nature, ie, "Raynaud's-like phenomenon," and increased thick ening and lighlnobs of the hands, there is little information regarding this disease in the dermatological | literature. Therefore, we wish to reJ, port two cases of this unique disease and to review the present state of our knowledge regarding the incidence, cause, sequel, treatment, and prog nosis. Accepted for publication Jan 18, 1972. Hrum the department* or medicine (Division of Dermatology) (Dr*. Markowitz, McDonald, and Ker/ner) and pathology (Dr Fethiere), Roger William* General Hospital, Brown UniA^^raily, Providence, RI. request* to Roger Williams General 825 ChalkMone Ave, Providence. RI ^1)2908 (l)r. McDonald). Report of Cases Case 1. --A 27-year-old white man en tered the Roger Williams General Hos pital for evaluation of tightness of the hands and wrists of approximately four months' duration. Two years prior to admission to the hospital, the patient worked in the manufacture of polyvinyl chloride as a vat cleaner for six months and thereafter as a bagger. One year prior to Admission, the patient first began to note blanching of his hands upon expo sure to cold that in time progressed into a bluish cyanosis of the hands accompanied by severe pain. He was seen by a local physician and was given indomethadn after being told that he had gout Eight months later, the patient began to notice progressive thick ening of his hands and forearms with lim itation of motion of the digits of both hands and the shoulder girdle, and spo radic arthralgia. Two weeks prior to hos pitalization, he accompanied his mother on her routine visit to her physician who noted the obvious changes in the skin of hiB hands and wrists, and recommended hospitalization. Pertinent physical findings were limit ed to the integument. The hands were diffusely pink in color, and on extension or flexion of the digits became totally blanched. The examiner was unable to move the skin over the underlying subcu taneous structure. There was a continua tion of (be skin involvement from the hands to the forearms and elbows with an accentuation and tendency for nodule or plaque formation about the extensor and flexor tendons of the hands and at the wrists (Fig 1 and 2). It was very striking to note that in the presence of the sclero dermatous appearance of the affected parts, there was minimal or no loss of hair. The patient was unable to tightly clench the fists. The lower extremities were normal except for the feet which had a mottled cyanotic appearance and thick ened cords of skin on the dorsum _pf the right foot. The Facial skin did not reveal stiffening beneath the eyelids or perioral radial furrowing. Telangiectasia was ab sent on the affected parts, fingernails, central portion of the face, and intraoral- ly- The following laboratory tests were per formed, disclosing values which are with in normal limits: hemoglobin, 14.7 gm/100 ml; hematocrit reading, 45%; white blood cell count, 9,500/cu mm; dif ferential coll count; 70% segmented neu trophils, 28% lymphocytes, 2% mono cytes; serum calcium, 9.9 mg/100 ml; phosphorus, 4.7 mg/100 ml; blood glucose, 101 mg/100 ml; blood urea nitrogen, 16 mg/100 ml; uric acid, 7.2 mg/100 ml; cho lesterol, 253 mg/100 ml; total protein, 7.6 gm/100 ml; albumin, 4.9 gm/lflO ml; total bilirubin, 0.2 rag/100 ml; alkaline phos phatase, 40 units/100 ml; lactic dehydro genase, 125 units/ral; serum glutamic oxaloacetic transaminase, 37 units; creati nine, 1.1 mg/100 ml; sodium, 141 mEq/liter; chloride, 101 mEq/liter; potas sium, 4.4 mEq/liter, venous pH, 7.36; ar terial carbon dioxide pressure, 48 vol%; total carbon dioxide, 27.5 mEq/liter. The following tests were negative or within normal limits: latex fixation for rheuma toid arthritis, C-reactive protein, antinu clear antibodies, VDRL test for syphilis, LE preparation (three times), creatinine clearance, thiodothyronine uptake (28%), urinalysis, and immunoelectrophoresis of serum. Results of pulmonary function studies were within normal limits. An xray film of the chest was normal. X-ray films of the hands (Feb 26, 1970) revealed a fracture of the tip of the distal phalanx r.f the left middle fingertFig 3). The results of additional studies of the forearms, elbows, arms, shoulders, and chest were within normal limits. The resuite of esophageal motility studies and roentgenograms of the upper gastrointes tinal tract were found to be normal, and an incidental finding of osteitis condensans ilii was noted. Follow-up x-ray films on Feb 16, 1971. revealed further bony loss and resorption of several distal phalanges of the right hand with the first, second, and fourth being most severely involved^ The left hand nad similarly"undergone further resorptive changes with the first, second, and third distal phalanges being most severely involved (Fig 4). Hematoxylin and eosin-stained sections of the skin of the forearm demonstrated a normal epidermis and skin appendages that were normal in size and distribution Arch Derm/Vol 106, Aug 1972 Occupational Acroosteolysis/Markowitz et al 219 CUSAROSS 00274 Fig 1. -- Cutaneous findings observed in occupational acroosteolysis. Note erythema, blanching, and thickening of digits, and ropy appearance of Skin on dorsal surfaces (case 1). Fig 2.-Forearm shows thickened, lobular or ropy nature of skin In occupational acroosteolysis. Hair ap pears normal In texture and distribution (case 1). Fig 4. -- X-ray film of both hands taken Aug 24, 1971. Note increase in number of lytic lesions in distal phalanges of both hands, and more severe bony destruction in left hand (case 1). (Fig 5V Pathological change*. w?|-t: mo. pronounced in the dermis, which op peered considerably thickened. The der mol changes were characterized by ; nonfibrillary homogenization of the colla gen and by the presence of thickened swollen collagen bundles radiating in al directions. These thickened bundles o collagen showed accentuated stain ini properties with eosin. There was soni* degree of interstitial edema, and an in flammatory infiltrate with a predomi nantly perivascular distribution made o lymphocytes, and a few histiocytes, won also seen (Fig 6). These changes of th< 'collagen were noted throughout the der mis and around the sweat glands. Then was no subcutaneous fat observed. Ver hoefTs elastica stain showed disorganiza tion of the elastic fibers, which appearec to be split and broken in some areas and condensed into thick bundles in other areas (Fig 7). Jancso's chlorozol fast pink and Congo-red fast green stains were done to detect the presence of particulate material which could have been identified as vinyl compound. These were negative Toluidine blue and Alcian blue stains re vealed metachromatic staining materia within the interstices of the thickenei collagen bundles. When tho specimen wa studied under polarized light, two types o collagen bundles were noted:, a steal number of large, thick bundles which po larized bright yellow, and a larger num her of smaller bundles which did not po larize at all (Fig 8). Case 2.--The patient is a 29-year-ok white man with a history of employment in the vinyl chloride polymerization in dustry for the past four years. He workee as a vat operator and reactor cleaner foi 12 months and subsequently as a chemi cal operator. In June 1970, the patient noticed a full 220 t"' V.n 106. A.Jj 1972 Occupational Acroosteolysis/Markowitz et a CUSAROSS 00275 Fig 5.-Hematoxylin and eosin-stained section of in volved skin showing normal epidermis and normal loca tion of sweat ducts. Note swollen and thickened collaeen 1x40). Fig 6. - Thickened bundles of collagen with accentuated eosinophilic staining properties. Note prominence of interstitial edema (x250). Fig 7.-Vcrhoelf's-stained section showing disorganiza tion of elastic fibers, some fragmented, others condensed into thick bundles (x250). Fig 8.-Specimen of skin seen under polarized light. Note thickened bundles of collagen that appear bright yellow In color. Other collagen Is less retractile (x25Q). ness of the hands which progressed to discernible thickening. Concomitant with I he above integumentary changes, other rtbaormaliUfcS, such as blanching and cyanosis of the Bkin associated with cold exposure, occurred. Within the few months prior to his clinic visit, the pa tient had been unable to extend hia hands. Abnormal physical findings were limit ed to the skin. There was thickening of the skin of all upper extremity digits with extension onto the dorsum of the bands, hut sparing of the palmar surface. The hands blanched easily, but there was no evidence of cyanosis, clubbing, or telan giectasia. Upon extension of the hands, the fingers ap|K'arc3~FTa\v-like. The pa tient was unable tocompleleTyextcnd the ^-nximal and distal interphalangeal digBy Laboratory tests, skin biopsies, and iiirtber evaluation were declined by the patient. --^oTtouent C Problems associated with the pro jection of vinyl chj*rfidc and its polymerg"hvc beegmultiple and varied. Harris1 described the vesicant action of vinyl chloride liquid when applied alone to the skin. It produces a sec ond-degree bum that heals within two weeks when properly cared for. Danziger3 reported two deaths in autoclave "cleaners due to asphyxiation while cleaning poTvmerinflHo"reactors after termination of the jaalymerization process. McCord/ in a recent editorial", briefly notes tbe death of a woman worker in the plas tics industry who, after exposure to molten polyvinyl chloride and methyl chloride cooling, developed acroosteolysis or a clinical picture that simu lated the findings of scleroderma. *This, incidentally, is the only report ed fatality of pORtpolymei-izatior process acroosteolysis. --Vinyl chloride (CH^-CHCll is a colorless gas at room temperature with a boiling point of--13.9C and a freezing point of--154C. It has a very pleasant odor which can be_dgtected in concentrations greater than yy 400 parti per million. In a gaseous state, it is highly flammable and ex plosive, its Hash point being -- TSC.'1 In the late 1940's, its properties as a general anesthetic were studied; how ever, it was found to have dangerous myocardial.irritahiljty-indueing pro perties at narcosis levels.11 For three or more decades, the chemical (plas tics) industry has used polymerized vinyl chloride to manufacture plas tics whose ultimate product may be Arch Derm/Vol IOC, Aug 1972 Occupational Acroostec CUSAROSS 00276 found as wearing apparel, food wrap / Performance of this particular pro- \ tive but not definitive cases. Our two pings, dentures, phonographic re i cedure (reactor cleaning) is the only cases occurred in a plant which is cords, floors and wall tiles, cable coat | one that hns been found to be common ings, shower curtains, and hundreds to all persons so far observed who considered small by industry stan dards, employing less than 100 per of other basic products used daily in suffer from occupational acro- sons in tho manufacture of vinyl lionies and industry. qsteolysiH. > chloride polymers. More than these Polyvinyl chloride of varying mo Dinmnn et al reported 26 cases, two cases may exist in the saim lecular weight ciVnTfiTpixiduced from after an extensivo survey of the fac plant, since one of our patients allnd vinyl chloride with the use or four tors involved in the development of od to the occurrence of similar physi basic methods and_ multiple minor occupational acroosteolysis in 32 cal findings in at least one other su modifications. In the more widely plants, and noted that all except one pervisory person. We feel that it is used process, deionized water, poly of the patients had worked as reactor well to add here that the health safe vinyl alcohol, methyl cellulose, gela tin, emulsifying agents, surfactants, buffers, trichloroethylene, catalysts cleaners; the-flne-eyrepfinn, a labors- | ty practices in this plant are at or tory' worker, had cleaned laboratory | above the norm for this particulai reactors.1 industry. (organic peroxides), and vinyl chlo "~BaggTfig is another task that has The symptom complex of occupa ride in liquid form are agitated and been found to be 'commonljr associ tional acroosteolysis clearly points to heated in the absence of oxygen in a ated with this diseasemowever,_aTr the systemic nature of this disease glas'i-lined autoclave or reactor. Af baggers "have bean reactor cleaners In most cases, affected indt\iduui- ter 10 to 16 hours (the length of time at one period of time during their have a complaint of discomfort, ie determining the extent of polymeri employment in the production of tingling, burning, pain, and tenjer- zation and molecular weight of the polyvinyl chloride. It is well to em ness on exposure to cold, aecompn finished product), the reaction is phasize here that noTases have been\ nie3 Sy redness, blueness, anr terminated. The finished product of .observed in individuals working with _j blanching.'This may occur in one ot the reaction is collected in a tank; (vinyTchloride, the finished polymer I both hands. Later a diffuse awellini impurities, including vinyl chloride, polyvinyl chloride, its copolymers, or \ of the affected part or parts is noted are extracted. The resultant poly in "processing the polymer into fin- \ '1'hiB is uccompaniod by difficulty in vinyl chloride, when dried, is a mass Vjsbed plastic products. J flexing or completely closing the of tiny particles of varying sizes, all These findings have led most ob hands. Clubbing of the fingers has of which are inert. The material is servers to conclude that one or more occurred in some individuals. Al then bagged for shipment to fabrica of the incomplete products of poly though roentgenographic evidences tion plants.7 merization is responsible for the dis of bony lytic lesions in the hands All of the processing up to the ease entity, occupational acroosteo may be present early in the course ol bagging stage is carried out in a lysis. the disease, the affected individual closed system. Most plants have Occupational acroosteolysis, first usually has no symptoms or com elaborate ventilating systems that described by Suciu et al in 1963,1 can plaints referable to these. In a small automatically and continuously ex best be described as a symptom com number of cases, lytic lesions of the change room air when the concentra plex consisting of a Raynaud's-like bones occur without evidences of a tion of vinyl chloride reaches a pre phenomenon, involving the hands, Raynaud's-like phenomenon. The determined level. sclerodermoid-like changes of the period of exposure to yinyj_chlonHe After the polymer has been ex skin of the hands and forearms, and polymerization before the onset of tracted from the autoclave, it is nec osteolytic and sclerotic lesions of the symptoms is variable, as short as one essary to clean the reactor before the bones, particularly the extremities month or as long as three years. \ next run. (Some plants clean after and sacroiliac joints. This induced Other associated symptoms as inter- | several runs.) In order to clean the combination is unique, and to our -mittent transient orthostatism and ^ reactor, one or more workmen are knowledge is limited to those indi tinnitus are described but arc diffi y required to hose the tank down with viduals, specifically to "polycleaners" cult to attribute to the disease. water; this is usually done from an (reactor cleaners) in the vinyl chlo The physical findings in the affect external position. After hosing, ride polymerization industry. ed parts, at first glance, simulate to a workmen enter the autoclave to There are no accurate data which marked degree those of acrosclerosm. remove a thin film of the polymer will give us a true incidence of the The hands are pink to blue to pale in which always remains on the reactor disease. Wilson observed 31 cases in color. The skin of digits and of the wall. This material, the exact compo 3,000 personnel involved in vinyl entire hand is thickened in a waxy sition of which is unknown, is thought chloride manufacture and polymeri and diffuse manner. In the early to contain vinyl chloride (its odor can zation.* Dinman et al reported 25 stages, thickening of the skin of the be detected), a quantity of the sur definitive cases in 5,011 employees hands and wrists is most noticeable factants. catalysts, emulsifiers, and other substances, "along with incom plete polymers of vinyl chloride. in si plants throughout the United" States^and Canada** Sixteen other individuals were considered sugges over the extensor and flexor tendons This thickening is sclerodermoid ir appearance and, when incomplete 222 Arch Oerrn.Vol 106. Aug 1972 CUSAROSS 00277 irkow,u et a rope-like or plaque-like quality to it. The skin in areas of diffuse thickening cannot be moved or caused to glide over subcutaneous tissues. Lunger's lines may be absent in affected areas. The most striking difference in the clinical appearance of this lesion and scleroderma is the presence of functioning skin append ages and the absence of polygonal telangiectases in areas of active dis ease. In areas where ropy or plaque like lesions arc noted, the skin takes on a yellowish cast. In extensive cases plaques may extend up to and include the skin covering the entire forearms. Skin changes without a Raynaud-like picture may be noted in the feet. f Abnormal rusults from laboratory istudies are practically nonexistent. | None of the laboratory abnormalities i) usually associated with systemic scleroderma are present in patients affected with occupational acroosteolysis. Abnormal x-ray findings indicat- I' lytic lesions in various developcntul stages are present in all cases of occupational ucroostoolysis. These lesions are generally limited to the distal phalanges of the hands, ulna, radius,. andZsgcroiliac joints. Early in the course of the disease, marginal and/or cortical defects oc cur. There is a loss of the cortex in one or more of the tufts of the distal phalanges. Later half-moon defects or cuts in the cortex of the tufts of the distal phalanges are noted. In the most advanced stages of the dis ease, the lytic lesions progress to cause transverse defects or fractures, and then complete resorption of the tufts and shafts of one or more distal phalanges. Involvement of the larger bones in the upper extremities may be evident in the advanced stages with cystic lesions and increased radiolucency becoming quite promi nent. Extensive erosive and sclerotic changes are also noted in the sacroil iac joints. Oddly enough, in spite of the ex tensive destruction of bony struc tures, there are no symptomatic complaints referable to the muscu loskeletal system. As evidenced by the progression of bony disease in our first patient, this process of destruc tion can continue for an as yet unde fined period even after the patient has been removed from the causative environment. (There appears to be no accompanying progression of the skin lesions on termination of expo sure.) His employment as a reactor cleaner was terminated immediately upon diagnosis of his condition in February 1970. His initial x-ray films of Feb 26, 1970 were rather unremarkable except for a trans verse defect in one digit. One year later, Feb 16, 1971, nearly all of the digits of both hands were damaged, and defects in the left humerus were now present. X-ray films of the af fected bones in the reparative stage show sclerosis in the region of trans verse defects with the eventual re sult of bony union with digital short ening. In some cases, fragmentation of tufts predominates with resultant fibrous union and fragmentation. The histologic examination of defective skin in case 1, although incomplete, demonstrated evidences of the disruption and fragmentation of old collagen, and fragmentation of elastic fibers with evidences of new collagen formation throughout the dermis. The epidermis and dermal appendages were not involved. These findings in most part are in accord with those reported by Harris. How ever, we were unable to confirm the presence of vascular involvement, ie, intimal fibrosis and medial hypertro phy.10 This preliminary evidence in dicates that in this process the defect in the skin occurs solely in the connective tissue; a similar situation probably exists in the connective tis sue of bone, thus accounting for the type of bony defect described from xray examination. Wilson0 believes the condition to be a combination of three factors: (l)a chemical insult, (2) a physical insult, and (3) personal idiosyncrasy be cause of the relatively low incidence (less than 3% of all produc.tiflH-finii_ ployees who had at one tifflP reactor ..* 1 2 3 4 5 6 7 8 cleaning experience). Treatment fbr this-entity is nonex- . istent to date. Removal of the affect ed individual from the environment is so far the only known preventive. The skin disease is thought to stop its progression after exposure is ter minated; however, it is evident that bony disease continues for an indefi nite period of time, eventually termi nating in one or more obvious bony > defects. This investigation was supported in part by Public Health Service grant GM 16538-03. References 1. Suciu I, Drejman I, Veleskai M; Investiga tion of tho diseases caused by vinyl chloride. Med Intern 16:967-978, 198. 2. Harris DK: Health prohlems in the manu facture and use of plastics, lint J Industr Med 10:266-268, 1963. 3. Oanziger H! Accidental poisoning by vinyl chloride. Canad Med Assoc./ 82:828-830, 1960. 4. McCord CP: A new occupational disease is bom. J Occup Med 12.234, 1970, 5. Patty FA, Yant WP, Waite WP; Acute re sponse of guinea pigs to vapors of some new commercial organic compounds: V. Vinyl chlo ride. Public Health Pep 45 1963-1971.1930. 6. Osier RH, Carr CJ, Krantz JC: Anesthesia: XXV11. Narcosis with vinyl chloride. A.needietialogy 8:359-361, 1947, 7. Cook WA, Giever PM, Dinman BD, et al. Occupational aernosteolysis: II. An industri.il hygiene study. Arch Encimn Health 22:74-82, 1971. 8. Dinman BD. Cook WA. Whitchousc WM, el al: Occupational aeroosteolysis: 1. Anepidermiological study. Arch Envinm Health 22.01-<:i, 1971. 9. Wilson RH. McCormick WE, Tatum CF.jri al: Occupational aeroosteolysis. IAM l 201 <. 581.1967. 10. Harris IIK, Adams WGF: AcroosieohMs occurring in men engaged in the poly mvrizatiiui of vinyl chloride, lint Med J 3:712.714, 1907. Arch Derm/Vol 106, Aug 1972 CUSAROSS 002 Occupational Acroosteolysis/Markowitz et al 223 ACRO-OSTEOLYSIS IN PVC WORKERS* C. T. GITSIOS, M.D. Esso Pappas Polyvinyl chloride (PVC) is a widely used synthetic resin. It has been manufactured commercially for over 35 years and is used in upholstery fabric, floor and wall tile, wire insulation, phonograph records and many other commonly used commodities. For many of these uses, the resin is mixed with other materials to achieve the desired physical characteristics. Basically the manufacture of polyvinyl chloride is accomplished by polymerization of vinyl chloride monomer. The process consists, briefly, in submitting a mixture of liquid vinyl chloride and water in the presence of catalyst to the effects of heat in large pressure vessels known as reactors or polymerizers. This produces polyvinyl chloride in slurry or latex form which is discharged from the vessel and conveyed elsewhere to be dried into a fine white powder. When the reactor is emptied at this final stage a deposit of white polymer is found on its inner wall. Air is then blown through the open vessel for at least a quarter of an hour, after which an atmospheric test for vinyl chloride is performed inside it. If the reactor is found to be clear of vinyl chloride vapor (below the acceptable TLV, 50 ppm), the cleaner enters it to clean the wall. The most common practice has l*ecn to accomplish the cleaning manually by using hand scraping techniques, with workers spending several hours each day on this job assignment. Personnel performing this job are commonly referred to as ``polyelcancrs''. In the past five years attention was brought to a new occupational disease which appeared in people engaged in vinyl chloride polymerization process. This was almost simultaneously reported in l.urope and the United States. Cordier et al* in France in 1966 first described an unusual condition which occured in two men employed as polyelcancrs. After doing this work for several months these employees developed symptoms resembling those of Raynaud's phenomenon and later, a skin eruption of the hands and in one case in the forearms, together with general asthenia antf drowsiness. The most striking sign, however, was the radiological evidence of lysis of `l'rc\rnir,l .ii thr Si\lh litriipean Medical Directnrt Meeting. Standard Oil Cnmpany,(N.J.), I'.irn, t railer, IV 70 49 CUSAROSS 00279 THE MEDICAL BULLETIN some terminal phalanges of the hands, and in one case of the feet. Most of these abnormalities disappeared and the bones showed signs of healing a year or two after the men had stopped work. The name of acro-osteolysis was given to this disorder. About a year later Harris and Adams (1967)* from Imperial Chemical Industries Ltd., plasties division, described two similar cases in persons engaged in poly merization. About the same time Wilson et al (1967),3 from the medical department of Coodrich Co., reported a detailed i^naK sis of 31 cases of occupational acro-ostcolysis observed among 3,000 workers involved in vinyl chloride manufacturing and polymeriza tion. The great majority of these cases have been characterized by two common factors, namely, (a) symptoms like those ascribed to Raynaud's phenomenon, and, (b) acro-ostcolysis of the distal phal anges. A few had no symptoms but had the x-ray evidence of acroosteolysis. Several of the patients had external skin lesions on the dorsal surfaces of the hands and forearms with a ropc-like appearance resembling changes sometimes seen in scleroderma. Some had clubbing of the fingers. It is worthwhile noting that only a few of the above cases have sought medical attention because of symptomatic complaints (soreness and tenderness of the fingertips and marked discomfort on exposure to cold). The majority have been found through x-ray examination of the hands. The above authors went further as to classify the positive x-ray findings into 3 stages according to the degree of the damage found. In an early stage the main finding was a loss or a small halfmoon cut in the cortex of the tuft in one or more of the distal phalanges without destruction of the bone. In the 2nd stage there may be a more severe lytic destruction with complete loss of the tuft and a portion of the shaft. In the 3rd stage there is often definite fragmen tation of the remaining tuft. During the healing stage this may go on to a complete bony union or remain as a fibrous union with fragmentation. From an epidemiological point of view it appears that the job assignment seems to be the only correlation found so far with the occurence of this syndrome. In general the syndrome has a low attack rate. In the experience of Wilson et al.3 it occurs in less than 3% of all production employees who at one time had polycleaning experience. It appears also that none of the cases in which the syndrome appeared had less than 12 months polycleaning experi- 50 CUSAROSS 00280 ACRO-OSTEOLYSIS IN PVC WORKERS cnee. It is believed by Wilson et al. that the condition is the result of three factors all of which must be present for occurence: (1) a chemical insult, (2) a physical insult, (3) a personal idiosyncrasy. The chemical insult could occur from one or more of the monomers, catalysts and/or intermediate reaction products existing in polymerizers. A low degree of exposure to these could occur from con* tact with the solid, slightly moist, residue in the polymerizer or to small quantities of vapor, absorbed either percutaneously or by inhalation. The physical insult is present in all "polycleaners" to some degree through the prolonged hand scraping operations as well as the occasional use of hammers to remove the residues. Personal idiosyncrasy appears to be an important factor because of the low incidence of occurence of the disorder and because of the fact that although all polycleaners are subjected to essentially similar chemical and physical insults, relatively few of them develop the disorder. A point of general interest is the possible relationship of this condition to collagen disease. One patient of Harris and Adams (1967) two cases, had in fact, been diagnosed as a case of sclero derma on clinical grounds 10 years previously. Cordier et al. (1966)1 mentions an unusual skin condition seen in their cases. Several of the cases of Wilson et al. (1967)J also had external skin lesions on the dorsal surfaces of the hands and forearms. Finally Suciu et al. (1963)4 in a paper describing conditions produced by vinyl chloride also referred to a skin lesion resembling scleroderma, but aero* osteolysis was not mentioned. Epidemiological Study Late in 1966 after the first information about occupational acroosteolysis became available, the Manufacturing Chemists' Associa tion arranged with the University of Michigan to carry out a large epidemiological study both for the MCA and for the industry. This study was carried out in the vinyl chloride industry and included questionnaires, x-ray examinations of the hands, job history and industrial hygiene studies. There were 5011 employees in 32 plants of 19 corporations in the United States and Canada in the survey. Controls totalling 2407 were drawn from the Tecumseh, Michigan, epidemiologic study. Of the 5011 workers, 1302 were found to have an x-ray abnormality of the hands. Most were found to be unrelated to acro-ostcolysis. The roentgen findings were correlated with the 51 CUSAROSS 00281 THE MEOICAL BULLETIN history of Raynaud's phenomenon, and diagnostic categories estab lished. Raynaud's phenomenon and characteristic x-ray changes establish the diagnosis of acro-ostcolvsis. An additional category involves severe roentgen changes of several fingers and is believed to represent the end stages of the disease. The investigators established a total of 25 cases with an addi tional 16 "possibles" in whom x-ray changes were seen but Raynaud's phenomenon was not. The ratio of patients with clinical disease to those exposed to the chemical hazard was 1:31. Eno Pappas PVC Operation Esso Pappas has operated a PVC plant since early 1967, with a work force of about 35 persons. Our PVC plant consists of K reactors and was originally designed to produce 12,000 tnetric tons/ycar. It is a batch operation and the vinyl chloride monomer used in the process is received through pipeline from the supplier. During the past 18 months after continuing experiments in improving PVC processing, a capacity of 20,000 mt/year was reached. Figure 1 is a view of the reactor room. The reactors are installed in two rows. The greater part of the 5.5 meter long reactor lies below the floor as you can see in Figure 2. Figure 3 gives you an idea of the shape and the dimensions of each reactor. After the process is completed the product is transferred from the bottom of the reactor to the finishing section where it is dried, screened and then fed into a bin for subsequent bagging. Figure 4 shows a close up view of the reactor. Although the materials of industrial hygiene concern in PVC production include vinyl chloride, methanol, catalyst, bisphend A, carbon monoxide and PVC dust, vinyl chloride monomer seems to be the most important. Since the polymerization operations are carried out in closed process, this provides little opportunity for employee exposure. The first industrial hygiene survey done by ER and E group on Dec. 1967 demonstrated that during normal operations the level of vinyl chloride throughout the plant is relatively low. 52 CUSAROSS 00282 63 CUSAROSS 00283 the medical bulletin 54 CUSARSS 00284 ACROOSTEOLYSIS IN PVC WORKERS There were stages in the production process, however, which resulted in brief exposure to high concentrations, for example: (a) During the addition of water to the reactors the air displaced from the reactor contained as much as 10,000 ppm of vinyl chloride. This was due to a leakage at the manual control valve on the vinyl chloride monomer feed line and was corrected, (b) Vinyl chloride monomer was released to the workroom when the reactor was opened to obtain a sample of the PVC following completion of the reaction, (c) Polymer removed from the reactors following cleaning was originally placed in open waste- drums. The concentration of V.C.M. in these drums was as high as 600 ppm. This was a source of airborne contamination and was eliminated by covering the drums and emptying them at the end of each shift. Following transfer of the product from a reactor to the finishing section the reactor is washed out with water and following this an air mover is attached by flexible duct to the reactor discharge outlet and operated until the concentration of V.C.M. inside the reactor is 50 ppm or less. This determination is made by using colorimetric FIGURE 4 - TOP OF PVC REACTOR - ENTRY tfATCH OPEN 66 CUSAROSS 00285 THE MEDICAL BULLETIN dcrcctor tubes. Entry of the technicians for cleaning is not per mitted until this level is reached. Reactor clean-out men are supposed to wear coveralls (plastic-coated or neoprene), work gloves and hard hats during this procedure. Following the ER and E hygiene inspection the recommendation was made that neoprene gloves should be used by the polydeancrs because through experiments it was found that this type of gloves was less permeable to V.C.M. In practice, however, these gloves were not found satisfactory for two reasons. First, they would tear easily, so that most of the time the gloves had holes and secondly, they were very uncomfortable to the technicians whose hands at the end of a reactor cleaning session were moist and the skin wrinkled. As a consequence the technicians were happy to see the gloves being torn and were not eager to change them. It was obvious that in this way the protection they were getting was minimal, if any, and so we had to return to the old canvas type work gloves. After all some protec tion was better than none. In addition to the industrial hygiene measures outlined wc have established the following program of medical check-ups for all people engaged in PVC production, testing and handling: 1. Yearly x-ray's of the hands. 2. A yearly periodic examination. Up to this time we have had no abnormal x-ray findings nor have there been any clinical findings related to the above disorder. Reference! 1. Cordier, J. M. et ai: Acroosteolysis et lesides cutanccs, associces chez deux ouvriers. Affectes au nettoyage d'autoclaves. Cah. Med. Travail 4: (Jan.) 1966. 2. Harris, D, K. and Adams, W. G. F.: Acro-osteolysis occuring in men engaged in the polymerization of vinyl chloride, Brit. Med. J. 3:712, 1967. 3. Wilson, R. H. et al; Occupational Acroosteolysis, J.A.M.A. 201:577, 1967. 4. Suciu, L. Drejman J. Valaskai, M: Contributii Studiul Imolnavirilor Produce de Clorurade Vinil. Med. Intern. 15.967, 1963. 56 CUSAROSS 00286 Occurrence of Alkylmercury Compound in Caustic Soda Factory Setya Yamaguchi. MU. PhD: Hisao Mattumoto. PhD: Michiyo llouhidt'; Sachiko Matsuo: and Shtutsuke Kaku, MD. Kurume, Japan A compound resembling methyl mercury has boon found In Dm mm surrounding a ceusttc sod* factory where only metallic maraury has boon usad In tha manufacturing pracaaa. Moat of mathyl marcury occurs In tha stodga of a boatman! pit for affluanf wator that oontalna Inorganic marcury. Chemical characteristics Identifying the physical propsrtiss and toxicity of tha compound aN IndP cata tha probability that tha substance to mathyl marcury. IVtlNAMATA disease has furnished tragic illustration of the danger of environmental pollution that may follow upon rapid and improvident industrial development. Studies of acceptable limits of mercury in biological and environmental milieus1 disclose several problems which urgently call for clari fication. It is established that fishes caught in a natural environment contain a certain amount of methyl mercury,4 though knowl edge of the origin and potential toxicity in these circumstances is still insufficient. From the viewpoint of public health, an evaluation of the biological significance of methylmercury as it appears in the food chain is imperative. This article describes recovery of an alkylmercury compound from the sludge pit of a caustic soda factory in which only metallic mercury has been used in the electrolysis of sodium chloride. The compound has chemi cal and toxicologic properties that seem to Submitted for publication Nov 30, 1070; accepted March 31. 1971. From the Department of Public Haalth, School of Medicine, Kurume University, Kurume-ehi, Japan. Reprint requests to Department of Public Haalth, School of Medicine, Kurume Univeraity, Kurumeahi, Japan (Dr. Yamafucfai). identify it as methyl mercury. Thifirst available evidence for alkylation organic mercury in an apparently inorganic system. Measurement of Mercurials in Caustic Soda Factories Samples of water and of sludge w. looted at several sites at two factoric surement of total mercury has been out by cold-vapor atomic ab method.* Identification and determin alkylmercury have been done by g: matography and thin-layer chrnn phy.4-* The results obtained are shim Table. Chemical Production of Substance .* i,< to Methyl Mercury in an Inorganic i. To confirm the production of m<" cury chloride in the process of eleci sodium chloride or thereafter, the experimental studies were carried oi 1. Measurement of methyl men ride in water containing metallic m< 2. Measurement of methyl mem ride in mercury bichloride (mercu ride) solution. 3. Measurement of methyl mem ride in a solution of inorganic (mercury bichloride, mercury [mercuric sulfate]) mixed with ;u carbon (carbon black, a mixture <>* and acetylene carbon black) (Fig 1 4. Measurement of methyl men ride in a solution of inorganic : (mercury bichloride, mercury mixed with calcium carbide or t > of calcium carbide (Fig 1, bottom / Arth Environ Health--Vol 23, Sept 1971 ALKYLMERCURY COMPOUND--YAMAGVCUI J5T AL 197 A substance similar to and thought to be production of a similar substance thought to ;i,,-thyl mercury chloride was recognized in be methyl mercury chloride was also ,i,,> lust two experiments (3 and 4). The identified in effluent water from the electrol- Fig 1 --Ratantlon tima* of two axparlmanfaUy aywthaahed aubstanee* and authentic mathyl nwr, ,,ry chlortda. Top. Synthasizad aubaUnca of axpartmant 3. latwm. Synthwizad aubatanoa of axpnmnt 4* iry. This b Ikyiaticn of mrently tota rcurials ctories kludge factories. acn c nic absotp ieterminatkxi te by gga \ of of e ?r, the fptyo< rried 01$ /l memffy allic /I mercugy Unercur^J yl organic :rcury with ixture ot' (Fig ivl ysis plant when calcium carbide or ns dpitate waa added and mixed with ',| effluent The retention time of the measured by gas chromatography corresponded to that of methyl ntor chloride. CzystaUfastton and Chemical Properties of Substance Fig 2.--Retention time* of a timilar aubctanca pro duced in affluent water and authentic methyl mercury chloride. 1, 2, and I art tha lubetance produced; 4 and B ara authantic methyl marcuiy chloride. Hie substance which was obtained i, periment 4 was collected and oystalli/. , the method shown in Fig 3. All re. were carefully checked in advance to . nate contaminanta. The crystaliine m. : Fig 3.--Method af extraction and crystallization of alkylmercury compound. o XCM HgS04 h2so4 10 gm 4,000 ml 250 ml + Calcium carbide 250 gm Mix and stand tor 12 hr. | + HCI (1:1) 100 ml Filtration Filtrate I-------------------------60 ml + Benzene 15 ml Benzene layer (Wash with 10 ml H20) Dehydration 400 ml + Chloroform 40 ml x 2 Chloroform layer 200 mg/100 ml Glutathione 20 ml x 2 Glutathione layer 300 ml + Ethel 150 ml Ether layer Gas chromatography (for production test) Ether layer obtained methyl me rated at 1 cin 1 ab shown in responded mercury c crystalline veloped oi the R, I for mercu sorption r was found of methyl 100 90 80 70 60 5(f 40 30 20 10 mp4* 4,000T 3,60i Fig methe Fig bromi 100 90 80 70 c 60~ 50 E f? 40 30 sfi 20 10 4 oooT 3,6 ** CUSAROSS 00289 "" ALKY LMERCVRY COMPOUND--YAMAOUCHJ ET AL 199 id luul the characteristic odor of l mercury chloride, melted and evapoit 173 (", and had 788 cm 1 and 1,190 ilM>rptum by infrared analysis as in Fig 4. These findings almost cor k'd with those of authentic methyl v chloride (Fig 5). A solution of the \ i Mine material was spotted and deI'C d on a thin-layer chromatograph, and .. I l>rtion w.u tcraped off and analyzed II ti rcury by the cold-vapor atomic ab;i l n method. The locus where mercury and showed the same R, value as that ivl mercury chloride. Toxicological Identification of Crystalline Substance The characteristic symptoms of methyl mercury chloride poisoning in the rat are ataxia and crossing of the hind legs when the rat is hung by the tail with the head down. The crystalline material was dis solved in water with the aid of propylene glycol and administered subcutaneously to rats once every two days (except Sundays) in a dose of 0.5 mg/day. The total amount of the crystalline material administered to the rat was 13 mg by the end of the experi- i 5.--Absorption of authentic methyl mercury chloride by Infrared analysis, using potassium le-dlsk method. Arch Environ Heaiih--Voi 23. S*pt mj CUSAROSS 00290 200 ALKYLMERCURY COMPOUND--YAM AtiUC/u /,y (/ Total Uncuty and Mathfl Mercury Chloride Found In EMuanta From Two Caun, -7^TM---- ! I, iii --___________ *C/C S(Vj,j f Factory A " "" Sgmplfl ElectrolyaU plant Small pM (water) Lar*a ptt (watar) Larg* pH (ttudga) Effluant watar (Watar) (Sludg*) Sadlmantatton pond (Water) (Sludga) Calcium atudga dapot * NO, not datectad. 1 otl Hg, ppm 4,1/ 4,13 3S9.0 | 0.29 19.96 0.11 25.39 26.27 Mathyl Mercury Chloride, ppm NO* ND 0.014 NO NO NO 0.001 0.003 ||t. |)]1( d 'Ml 1 Ml 2/ i l.o 0Oi U> t,> o os 2U b(j 254.45 Fig 7.--Crowing of hind legs in rit experiment*My tyntheslzed crystal ment, ie, 30 days after the first injection. Figures 6 and 7 show, respectively, the crossing of hind legs in rats which received authentic methyl mercury chloride and the crystal obtained experimentally. Hie normal leg reflex of a control rat which received only propylene glycol is shown i The rat was killed after the n ataxia, and the amount of ir> chloride in various organ* w The following tabulation show of methyl mercury chloral.\ Arch Environ Health--Vol S3. Sept 1971 A: pr* CUSAROSS 00291 I alkylmercury compovnd--yamaguchi ET At 201 yl mercury in a natural environment have been reported previously.* The discovery that methyl mercury chlo ride may be produced in an inorganic sys tem similar to that used industrially in caus tic soda plants raises problems of major importance. In the Industrial situation the reaction has occurred mainly in a sedi mentation pit where a precipitate of calcium carbide is added to neutralize water from the electrolysis plant These observations may indicate the main source of the methyl mercury in the effluent material from cam- tic soda plants. This statement does not imply that other possibilities may be neglected. A trace amount of methyl mercury has also been produced experimentally in reaction of inor ganic mercury with amorphous carbon--the material of which electrodes in the electroly sis plant are fabricated. The demonstration of the possible produc tion of methyl mercury in a commonly used inorganic process raises serious questions. These apply to both the amounts of methyl mercury produoed In such a fashion and to the potoitial entry of this material into biological systems. If these processes occur, they may have significant effects on human health, especially if methyl mercury should enter the human food chain or if scene bio logical forms concentrate the substance. Nocmal of control rat. million, found in the organs of a rat > the synthesized material was ad- i. , Comment indications of occurrence of meth 1. Berlin M: On aatfanating tfaraahold Hnrfta far marcury in biological material Aeta Mad 8cat%d 17S (auppl 396)tl-29,1963. 2. Waste!) G: Determination of msthylmsrcury compounda In fnndatadfa: H Dstaandnsttow of mathybnarcury in fldt, agg, tnmt, and Bvsr. Acta Cham Stand XlilTW-UOO, 1987. 3. Yamaguchi 8, MataunxSo H: Ultra mfctodator- minatim of maacuiy In biological materials by atomic abaorptian photometry. Jap J Induatr Med 10:125-133, 1968. 4. Yamaguchi 8, Mateumolo H. Ultra-micro <k- tarmination of alkylmwcury compounds by gas chromatography. Kuruma Med J 10:33-42, 1989. 6. Yamaguchi 8, Msteumote H, Hntdds M, st al: Mkrodetarmtaatton of organic msrcuriala by thin-layar chromatography, Ruruma Mad J Ild3- 56. 1989. 6. Wood JK Kamaady F3. Run GO: Synthaaia of msthyhoiarcary by axtracts of a methanogaadc bacterium. Nature 230(173-174, 1988. Arvh Environ Health--Vol 23, Sept 1971 CUSAROSS 00292 Medicine del Lavoro March 1970 (Vol. 61, n.3.1970) pp 174-179 Istituto di Patologia General dell'Universita di Perugia Direttore: Prof. A. Caputo PATHOLOGY OF VINYL CHLORIDE P. L. Viola During the last years a syndrome characterized by alterations of the skeleton, teguments, nervous system and hepatic function^* 2, 3, 4, 5, 6 ^as been observed among the workmen associated with vinyl chloride polymerisation process. An experimental programme lias been performed in order to evaluate the toxic effect of vinyl chloride on the animal organism, and in order to try to reproduce in rats the acroosteolytic lesions observed in man. MATERIALS AND METHODS Twenty-five Wistar male albino rats, of average weight 150 gr., were exposed to vapours of vinyl chloride 4 hours a day for 5 days a week during 12 months. The animals were kept in a plastic air-tight container through which there was a constant flow of air containing 3% in weight, equal to 30,000 p.p.m. of vinyl chloride. At the end of treatment the surviving animals were killed at twenty-day intervals, and the paws, brain, liver, kidneys and thyroid were examined histologically after fixation, inclusion and colouration by the ematoxylin-eosine. Van Gieson, PAS, Weighert, Bielschowsky-Gomori methods* Twenty five rats of the same breed were set aside as a control. RESULTS During the period of exposure the animals were slightly soporific, but the first few months of treatment were well tolerated and the rats showed no change in body growth or behaviour and no organic alteration visible macroscopically or by radiological means. After ten months some of the animals began to show a decrease in weight, in agressiveness, in their reaction to external stimuli, and often a disturbed equilibrium. Thirteen animals died from cardio-respiratory complications. Two animals died from hematoperitoneum. Most of the animals showed pathological involvement -2Pathology of Vinyl Chloride P. L. Viola of the brain, liver, kidneys, and thyroid. pathological alterations of the skeleton. Six rats showed histo- The small metatarsal bones showed an extensive periostal proliferation of cartilage-like material apparently originating by metaplasia directly from'the bone. All around the newly formed cartilage the cellular components were compressed and arranged tangentially to the cartilage itself, forming a perichondra1 layer. The isogenous cartilagenous groups were irreg- . ularly arranged and Lhuii nuclei were of varying size and often number per cell. The edges of the cartilage were irregular, showing digital extroflexions resulting from a varying growth potential. There was also evidence of chondroid metaplasia in areas of mature compact bone, in which the cartilagineous elements were grouped around a central nucleus of bone, as in typical osteochondromatosic processes. In the small bones the chondroid metaplasia was often very extensive and the bones seemed to be impregnated with a mucoid substance which altered the characteristic disposition of the bone tissue obliterating the cement lines. The skin of the paws showed areas of hyperkera tosis superficial thickening of the epidermis, vacuolization and degeneration of the basal layer, disappearance of the cutaneous adnexa and modest accentuation of the papillar layer of the derma. An almost constant state of edema was observed in the epidermic zone. The connective tissue showed dissociation of the collagen bundles and a diminution and fragmentation of the elastic retic ulum. The small arterial vessels showed signs of endothelial fibrosis with a thickening and dissociation of the elastic membrane, often accompanied by a partial hyaline degeneration and homogeniza tion of the walLs and pro l i ferut ion of the endothelium. Some of the vessels appeared completely blocked by a proliferation of the connective tissue in a-formation not unlike that of onion skin. CUSAROSS 00294 The small nerve bundles were often surrounded and invaded by' fibrotic processes. A microscopic examination of the brain revealed diffuse degenerative lesions of the grey and white matter. The external granular layer was often reduced and in some areas this was true also the medium sized and giant cells. Numerous examples were found of`hypercoloured, atrophic neurons with disappearance of the nucleoli and sometimes also of the nucleus itself. At the level of the white matter there were zones of intense, reactive gliosis consisting for the most part of cyto plasmic and fibrillar astrocytes, some of which were arranged in a concentric disposition around the blood vessels. There was evidence of neuronal phagokaryosis with satellitosis and the deposition of neuroglial elements around the altered nerve cells. -3Pnthology of Vinvl Chloride P. L. Viola There was modest: proliferation of microglial elements, especially in areas of more intense gliosis and zones of intense spongiosis showing an accumulation of astrocyte-type elements with basophilic cytoplasm and abounding in gemistocytic and microglial elements similar in appearance to "scavenger" cells. The cerebellum showed signs of atrophy of the granular layer which was often represented only by a few isolated nuclei. The layer of Purkinjc cells was in some places protoundly modified, the cells appearing to be undergoing intense degeneration and all the various stages of this process were observed, from the whole cell to the small homogeneous bodies with indistinct outlines which represent the most damaged form of the cell. Except for small and limited areas, the molecular layer seemed to be well preserved. The liver was often of increased volume, sometimes subicteric in colour, with a smooth surface and somewhat more brittle consistency than normal. A histological examination showed in the majority of cases signs of diffused interstitial hepatitis with numerous hepatic cells in the grip of regressive processes varying from forbid degeneration of the cytoplasm to necrosis with marked cytoplasmic and nuclear polymorphism. Some of the hepatocytes showed giant or double nuclei. In these areas of cellular necrosis a corpuscolar exudation was always present consisting of round cellular elements of the lymphocyte or plasmacellular type. There was evidence of an abnormal proliferation of the Kupffer's cells, which were often hypertrophic. The triangular spaces appeared to be increased by the infiltration of round and polynucleated cells and eosinophiles showing marked polymorphism. The portal capillaries, centrolobular veins and sinusoids were often blocked by numerous centrally-located areas of partial necrosis, often accompanied by a diffuse steatosis in the form of small drops with clearly-defined areas of acidophile necrosis and the formation of elements similar to the round acidophile bodies of viral hepatitis and the "Cauncilman" bodies of yellow fever. In certain cases evidence was found of an intense fibrosclerotic reaction alongside the degenerative processes. The kidneys did not appear to be excessively altered by the prolonged treatment with vinyl chloride, although they showed signs of tubuloncphrosis, sometimes accompanied by chronic interstitial nephritis. The thyroid often showed a colloid goitre and a marked increase in parafollicular cells. CUSAROSS 00295 -4Patholoay of Vinyl Chloride P. L. Viola Tho control animals showed no histopathological alterations of the skeleton or of the various organs. CONCLUSIONS This research confirms that the animals are sensitive to the toxic action of vinyl chloride. The lesions of the bone and connective tissue are similar to those noticed in experimental ostoo-latyrism and to those described in a man affected with acroosteolysis of the hands (Marin). It should be pointed out that the roentgen ological findings of skeleton in man rests on cartilaginous transformation of the bone tissue. Therefore according to reccomendation made at XVI International Congress on Occupational Health of Tokyo (1969) I should like some precautions to be taken in the manufacturing plants polymerizing vinyl chloride, such as reduction of the threshold limit value of monomer, and substitution of manual cleaning of autoclaves by automatic devices. SUMMARY The results of this investigation show that animals exposed to vapours of vinyl chloride may show degeneration of the skeleton and connective tissue with histopathological pictures similar to those observed in human acroosteolysis of the hands. The bones in fact undergo processes of intense periostium growth and diffuse, chondroid metaplasis. The connective tissue is dissociated into collagen bundles with a reduced number of cells, the elastic reticulum is markedly reduced and fragmentary, the small vessels of the deep layers of the derma show hypertrophy of the walls with a diminution and sometimes obliteration of the lumen, the nerve endings are surrounded and infiltrated by fibrous tissue. Degenerative processes of the parenchyma were observed in the brain, in the liver and in the kidneys. NOTE: Figures on available copy were not suitable for reproduction They are as follows: - ' ` Fig. 1 -- Periostal proliferation of metatarsal bone of a rat 10th inonl.lin old, exported to vinyl chloride vapours for 12 months Fig. 2 -- Periostal proliferation of metatarsal bone of a rat, 16th months old, exposed to vinyl chloride vapours for for 12 months '-S A R O S S 00290 -5Pathology of Vinyl Chloride P. L. Viola Fig. 3 -- Periostal proliferation of metatarsal bone of a rat, 16th months old, exposed to vinyl chloride vapours for 12 months. Fig. 4 -- Chondroid metaplasia in mature bone of metatarsus of a rat, 16th months old, exposed to vinyl chloride vapours for 12 months Fig. 5 -- Chondroid metaplasia in mature bone of metatarsus of a rat, 16th months old, exposed to vinyl chloride vapours for 12 months Fig. 6 -- Chondroid metaplasia in mature bone of metatarsus of a rat, 16th months old, exposed to vinyl chloride vapours for 12 months CUSAROSS 00297 ff./3 CANCEROGENIC EFFECT OF VINYL. CHLORIDE P. L. Viola (Regina Elena Institute for Cancer Research) Rome, Italy Presented at the Tenth International Cancer Congress Houston, Texas May 22-29, 1970 Thu; demonstration of oncogenic activity cf some chemical organic compounds employed for the prex->aration of "plastics" has been widely investigated and the limits and the effective ness of their oncogenic power have been well defined. The present investigation demonstrates that it is possible to obtain for some experimental models a marked carcinogenic response to a monomeric precursor, i.e. vinyl chloride, of plastic polymers which follows a peculiar pattern for different tissues and organs of the rat. Twenty-six Wistar (AR/IRE) male albino rats, of the average weight of 150 gr. were exposed to vapours of vinyl chloride V hours a day for 5 days a week during 12 months. The animals were kept in a plastic, air-tight container through which there was a constant flow of air containing 3% in weight equal to 30,000 p.p.m., of vinyl chloride. At the end of treatment the surviving animals were killed at twenty-day intervals, and the most important tissues and organs were histologically examined by conventional methods. Twenty-five rats of the same strain were kept aside as a control. During the period of exposure the animals were slightly soporific, but the first few months of treatment were well tolerated and the rats showed no change in body growth or behavior and no organic alterations visible macroscopically or by radiological means. 65% of the animals developed tumors of the skin and 26% of these showed tumors of the respiratory tract exclusively localized in the lungs. Very few animals developed tumors in the bone and in this case the tumors were localized in the metaphysical region of the femurs, and it is worthy to mention that the femurs^of both posterior limbs showed the carcinogenic transformation. Tumors of the skin The skin transformation which developed more frequently in the para-aural region, has been the epidermoid carcinoma, but we have seen also papillomas and rarely mucoepidermoid carcinomas. (TSAROSS 00298 -2CanrococTonic Effect of Vinyl Chloride P. L. Viola Tumors of the respiratory tract Even if as far as the percentage is concerned these occur in a smaller number, their morphologic appearance is mainly of an adenocarcinoma; only in one rat it has been observed a tumor of the epidermoid type. Sometimes the tumor showed an early developmental stage and consisted predominantly of cubic or columnar cells arranged as regular or irregular tubular and papillary elements supported by poorly developed fibrous stroma. Tumors of the bones In the metaphysical region of the four limbs a large proliferation of cartilaginous tissue arises outwardly to the periostium and seems to derive directly out of the osseous cortical by the growth of its cells. The cartilagenous growth is dishomogeneous as it is shown by the extension of finger-like prolongations into the boundary of neoformed tissue. Beside the chondroblastic, chondrocytic and angiomatous areas, manifestation of noticeable growth power, there are cartilaginous zones with regressive features, as fibrosis and hyalinosis. The results reported above indicated that vinyl chloride is an effective carcinogenic agent for the rat. As for many carcinogenesis studies, where multiple tumors arise at. different sites, in different tissues and organs, the data obtained need to be evaluated considering a more prompt positive response according to the ideal concentration of the carcinogenic. It is noteworthy to emphasize that the cutaneous system represents an impressive pattern of susceptibility to the vinyl chloride. Another point to be considered is that all the cutaneous tumors developed in the same site, i.e., the region including the area in which submaxillary and parotid gland are located. No implications to human pathology can be extrapolated from the experimental model reported in this paper. CUSAROSS 00299 I lie ..n.,ii<xu.i, z-rnl j tioncr .1 (c swelling of I he |.i<hiey p--enchyn'n, histulopical picture showed p ar opiihcli.il pit'lifer.iliou. (icn assuming *Ic of lubuloncjhrosis. v-ilh progressive increase in the thickness of the cpideimis 1SU!JS M),r rates of survival and the main findings arc summarized ^g;!.lc I. Almost all the animals (levc'op:d lumors of the ,n j:ul lungs. Very few animals developed bone tumors; in it cases, the tumors were localized in the metacarpal and Utaisal bones of all d extremities. Skin tumors were by far ; most frequent, .-.mounting to 65 or 703.. Shin Tumors. The tumor that developed most frequently in : f jraaurieidar region was the epidermoid caicinoma. Imt we ) observed papillomas and rarely mucoepidermoid r.-inomas. In all cases, (lie ncij-usins were of epithelial lure. The 3 patterns noticed cannot be compared to vaiious ,'otypcs but rather to a transition of one type into the other , and which is more likely, to different stapes of the same oliferative type. The papillary warts of exophytic type had a fihums vascular stroma and various degrees of inflammatory lymphocytic infiltration, marked hvpcikciaiosis, paiakcratosis, acanthosis-, and areas of individual dyskeratosis or pearl-like homy formations. The cpitliclial ccl|s of the penetrating columns (Tip.. 2) were irregularly arranged`and were frequently accompanied by an inflammatory infiltintion of the dermis. The typical features of the Malpighian layer and of tire stratum cotncum of the pticklc cells and of germinal layers wctc easily recognized (l-ig. 3). The horny laycf was composed largely of cell nests, which appeared at certain points within lire epithelial masses and assumed tbe well-known appearance of "horny pearls" (Fig. 3, arrows)', they were made of'flaltcncd and compressed prickle cells without nuclei and were located around a central core of keratin. Table 1 Oncogenic effects of inhetr-d tiivl chloride as a (unction of time Tlie animals were exposed <o vinyl chloride sapors for 4 hr a day. 5 day* a week, for a lout of 12 months, its a constant fidw cl' air containing 3% v/v vinyl chlorine. Rat 1 2.3 4 5 6 7 8 14 16.17 2] 22 23 24 25 . 26 Survival rale 300 280-300 3)0 333 337 347 347 354 359 3S0 38Q 380 380 '. t 380 380 Tumor* Skin Lungs Hone* Miicr>cpitfermoiil carcinoma Epidermoid carciiionu, kcratini.'int type Epidermoid carcinoma, kera tinizing type Papilloma, kcialotlc type Epidermoid carcinoma Epidermoid carcinoma Mucoepidermoid Carcinoma Epidermoid carcinoma Epidermoid carcinoma Epidcirnoid carcinoma Epidermoid carcinoma Epidermoid carcinoma Epidermoid carcinoma Epidermoid carcinoma Epidermoid carcinoma AdcnoacanU'omt* No tumor Adenocarcinoma No tumor No tumor No tumor No tumor No tumor Adenocarcinoma No rumor Adenocarcinoma No tumor Murui-producing adenocarcinoma (alveolar cell carcinoma?) No tumor Squamous cell carcinoma Osteochondroma No tumor . No tumor Osteochondroma Osteochondroma No tumor Osteochondroma No tumor No tumor No tumor Osteochondroma No tumor No tumor No tumor No tumor i 1971 t 517 CUSAROSS 00300 pm L. Viola, A. Hirotti, and A. Capuio 1 Keraiinization was irregular and often pjrakcratosis was cartilaginous zones possessing, regressive features, si:,-'i observed in tl>c areas of (tic tumor in which the cells were fibrosis and hyalmosis. The perichondrium appealed oft-.-n loosely aggregated and uru'ergome, an individual rather than a collective type of keratim/ation d). In dyskeratotic areas, a few epithelial cells tended to form pearls. The tumor seldom showed an undifferentiated growth with cellular plcontorpliism and sever.;! mitutic figures (Fig. 5). A few compressed and structurally altered fibrous tissue. In some Cases, the tumor growth was iclntcd to the stae the endochondral ossification occulting, below the "cpiph-, plate.** Ossification was irregular, so that osseous u.iFnvaried greatly in thickness and contours. In other cav.-s. f<,, tumors showed little nests of isolated pale cells (hips. 6 and 7) active cellular proliferation, cartilaginous areas, chon.I of 3 types: mucin -producing cells (originating from the duel developmental nests, and calcified hones occurred in epithelium of sweat {-.lands ur salivary {-.lands); squamous cells; decjrcr.portions of the trabeculae (Fig..18). and intermediate evils with minor tendencies towards The new formation appeared to be art osteochondroma differentiation. consisted essentially of a bony protuberance capped Respiratory Tract. These tumors, 3llhouf.li occurring rarely, cartilage and a fibrous layer, which represented were mainly ndcnocarvinomntous. Only in I rat did we observe perichondrium. an epidermoid tumor originating from the epithelium-covering The fibrous layer was continuous with die periostem cells. Sometimes, the tumors were seen in their early the adjacent cortical bone and extended inward to form s development and consisted predominantly of cubic or separating nnd enclosing lobules of catidagc. columnar cells arranged as regular or irregular tulmlai arid Control Animals. The control rats were kept under the - papillary elements fl ip. 8) and supported by poorly developed condition.-; as the experimental rats and at (he appropriate fibrous slioma (Fig. 9). were subjected to a constant (low of air without In other cases, glandular structures were often imperfectly chloride. None of these animals developed tumors o; ilu- formed ,Vad appealed as sheet-like proliferations of of parenchymal lesions developed by the tals that m undifferentiated or pleomorphic character. The cells showed a vinyl chloride. In a very few of the control rats, there ' tendency to extend into the pulmonary parenchyma, thus swelling of the liver and kidneys. simulating the microscopic features of the so-called alveolar cell carcinoma (Fig. 10). Sometimes, this was the prevailing pattern. The pulmonary air sacs \setc limited by 1 or more DISCUSSION .layers of cubic, columnar, ci polyhedral cells with abundant ) cytoplasm that was faintly eosinophilic (Fig. 1 l), frequently, As in many carcinogenesis studies in which multiple tv adcnopnpillnry excrescences spreading, into the alveolar spaces arise in different tissues and organs, the data must be eve! wctc present. .......... in terms of a name prompt positive icspons* to be obi In some areas, foci of cellular polymorphism with with the ideal concentration of the cnicinogemc comp hypcrclnomatic nuclei were noticed; mucin was produced in The cutaneous systrm is the most susceptible to the one; varying amounts and secreted into the lumen of the tubules effects of vinyl chloride. and acini. There wctc small pools of mucin in which signet ring cells occurred, either alone or in smidl clusters (Fig. 12), The alveolar walls were often quite thick and, at times, showed an inflammatory infiltration. As mentioned before, a single tumor showed squamous stiucturcs and appeared to have been formed mainly by spindle and oval undifferentiated cells (Fig. 12). Our experimental data do not explain why the cm? tumors developed in the same site, i.e., the region m.l the area in which the submaxillary and parotid phnb located. It is possible that the salivary glands may by min the concentration or excretion of vinyl chlonde or so ils active decomposition products. This hypothesis is stn supported by morphological findings showing the sp Hones. In the metacarpal and metatarsal regions of the 4 tendency of the developed tumor to appear limbs, a latg.c proliferation of cartilaginous tissues arose mucoepidermoid carcinoma, which indicates the outward fiom the periosteum and. from the appearance of its contiihulion of the mucus glandular cells to the turn cells, seemed to derve direrdy from ilie cortical hone (Fig. growth Such kinds of histotyncs are often related m 14). The periosteum also grew and m some areas spread as glandular aggregates, and. therefutf, the histogenesis m * fing.cr-likc prolongations into the newly ft'lined cartilage (Fie. ir.iicocpideimoid carcinoma lias been restricted to ib: -- 15). In these places, a gradual loiUMiion between fibrous intercalated ducts. This hypothetical mteiptcron r. cartilage, periostc.um, and bone coulJ be noticed. confirmed by future experiments in ulmh the act.n,: The newly formed cartilage .appealed nregular with atypical vinyl chloride should Fe restricted to the saloary sync ron areas; the cells, which had nuclei lan-or than the normal the concentrations used, salutation and vetting of d ' chondrocytes, lay m well-formed, capsul.ited lacunae. Flic cells might well he expected. Under these encumstam. C/3 occurred singly, in pairs, or in tetrads and, although of natural cleansing halm of the rat might add a different si/.c and shape, they usually contained a single, ingestion problem with subsequent coiRYiiti.riron o: datkly stained nucleus, llic cartil,urinous giowllt was not chloride in the s.divaiy glainh. II. L-. -I < homogeneous, as shown by the extension of the fin;:er-hkc concentration could ` rhe result ol the diliicul D prolongations in*o the luniud.iiy of newly formed tissue. complete cleansing hv die rat. U Resides (lie cltomlioblastic, chomlroe) tie, and angiomatous The neop'.islic response of the lover iwpint-v, areas which indicated a rapid growth, tlioie wore also although of lesser magnitude, is ol teles an i w:-m m ,1,. (cnniSi one morphologically similat to .'ho sgrihed .(.. the hypothesis th:U irmetispiodtui;r, cells may ' \.3i,]e ol. rct-ciunp vinyl chloride or its decomposition ,j i.*ft seems to lie tolerant once mote. Obviously, a -pt 'iaictpictnlion is requited fot the pnthn|;cnc*i$ of the tiiiius and for their simultaneous incidence at the level ; jH /, limbs. lfcucnces I Jljncijce, M,. ami bates. R. Prevalence of lletcroploidy in Plastic j gm-inductd Primary Sarcomas. Urit. J. Cancer. 20: 555-563, |9AG ) ii/.W. Cm fn<1 buocn, L. Polymer 1 uniotigcncsis; Multiple j'tcnfopl-'Stic Clones in Priority Order svjih Clonal Inhibition. Pioc. Sr:. I'spit. bio!. Med.,/25V 1153-1 IS-. I'JCti. \ grand, G., Ituoen. L., and lliand. I, Malignant Transformation and Miiitfilicn In Non-dividing Cells duiing Polymer Tumor igeneMs, fie:. Soc. J sptl. (liol. Med., 17-t: 675-678, 1967, , G., t"ioen, I... ;<r.d brand, I. Carcinogenesis from aster Implants: fie* Aspects (tom Chromosomal anJ Transplantation Studies during Prcrualijjnancy. ). Natl. Cancer Inst., 39: 663**679, J7 0. t i J. Drue) rry. It. I-s.pciiincntcllc V...r.u*rc vuiu Michaiiivtrms slct Cafiinoicncn Wiil.uf'". Ar/iv mill li I I oisrh., I: 3K3-3rl5. t`>5| 6. Iliirpcr, \'.\ C. Cancer l:ulticti-'ii Uy I'olyiitetlms and Polysilicone Plasties. I. N'.ut. Cancer Itsst.. .?. 1 tills -1077, 1964. ?. Johnson. K., Ituo.-o. I... brand, I.. ami I'raml. C. Polymer" Tumoiigcuciis (lon.il IK'iamiiurion of llisinp.ithotogieal Ch.* Rustics duiing Early 1`icucoplasia; Ui lationslnpt to Kai; )pe. Mouse Strain, and See. j. Hail, '.'auecr lust.. VdUJ-793.1970. 8. Kc^an, A. Experimental lllatlnmogfnciit Caused by Synthetic iVlyntofi (Plasties). Mrdttsina, Moscow, /.* 215 -- 237, 1965. 9. Maitrrtrrwtteo, li.. l-'tv'we, A. M.. Cliriili. II.. and l).inti;rr, I), Acute Inhalation Toxicity of Vinyl Odoii.le to Laboutlnry Animals. Am. Ind.llyp. Assoc. J,, 21: 394-397. I960, 10. YoiLcison. T. I*.. Oycn. I'., and l<oue, V, K. The Toxicity of Vinyl Clilondc at Determined by kepcated Exposure of l.aboratory Animals. bid. Ilvp. 1., 354-361. October 1961. 11. Van Duren. 0. E., Slvak, A., Goldschmidt, H. M., Kate. C.. ami Melcltionne, S. Ca/cinnpr.`icily of (laTo-Ethcrs. J. Nall. Cancer Inst., 4*481 -486.1969. 12. Viola, l\ E. Pathology of Vinyl (`liloiide. 16h International Congress of Occupational llealt'i. (Communication No, 38). Tokyo, 1969. Photomicrographs of the original article are not being distributed with this copy because of the poor quality of their reproduction. I i;s. 1 to 1S. AH sections were stained ssitit II &. E, J'if. E Squamous cell papilloma of the skin. X 25. 11,*. J. Transitional sl.ifC from papilloma Ik infiltrative type of cancct. X 80. Pif, 3. t'lm-ci hl:': trabecula" branch to hunt secondary ptocesscs showing horny pearl formation (arrcni-l). X 25. ! <r- 4. Dysl ciatulic area, l ew cpuhcTi.il cells svith a tendency to form whorls. Little capacity to develop into homy pearls. X 250. fig. 5. Atjpiral cells partly l.scJcm,- prickles and showing considerable variation in sire, shape and many mitotic figures. X 250. I it'.. 6. M.AOi'pideri.n-.iJ skin t-.imof. Occurrence of bjdiopic epidermoid cells, biral cell;, column,-.; cc V'lTions. X 100. and liilit. cell: in -.a.ions I 7 7. Muc-cpidermoid skin tumor, showing differentiation of masses of squamous epithelium from columnar cells, lining and proliferating into f'rJ:') luliul.w `paces. X 100. 11,'.. S. Mufi.mvhil.ir ai/cMoearcinon.' of the lung .wisinr. from a segmental bronchus. X 25. I if 9. Detail of ltg, 8 sii-issinp tulnii.if ->pi-11-r-rts*s injile up bj cellsavtth hypcrchromatic nuclei. I P, 10. Nr.ilnl.it btoiu hiol it jls colar mucus si s te I mg adenocarcinoma. X 100. I V. 11. Ih tail of I ig. 10, sinus my an als cun-genie p.` Item. X 250. v 13. Mucus proiluemp celts \i uh hyperehromatie and pleomorphic nuclei and occurrence of signet ring cells. X 250. 11* l3..SrputMtius sell v.uctiuimn of the lung, X 100. 1 >f. 11. Osieiichs'ridts'ma Ueseloping as a protuberance from (lie small bones of metacarpus and metatarsus. X 2S. * i.'. 13. Mjgnifi. alum of Fig, H. The ptuiubcrancc consist! of bone trabeculae, capped by cartilage, and a fibrous layer funclio/iing as "^mitii. X UK). fli'ts'chniidroma. r.nrilagirri'us prowlh rh.ir.ieirn/cd by fingcrTikc proliferation. X 100, . OsUocb.oiidiiiiii.i, Area of cnsloshfuul.i il ossifieatisui. X 100. >r' ^^-'cl'uljr atca of an oili ocboudtsup.i showing the (tansition ftom cartilage to osteoid. X 100. CUSAROSS 00302 W 1971 519