Document LpzMrzNM2GnXe793Jj2VGYJj7

PCBSi A PEBSPECTIVE FOB THE DIE CASTING INDUSTRY By Dc. John H. Craddock Product 4 Environmental Safety Director Monsanto Company St. Louis, Missouri July 26, 1983 Polychlorinated biphenyls (PCBs) have received considerable attention over the last 15 years because of concerns about their environmental persistence and their possible effects on human health and the environment. They arc pervasive and misunderstood. PCBs have come to be among chemicals most fearsd by many persons. PCBs are now highly regulated. They are the only chemical substances singled out by Congress for "laaiedlate" regulatory action under the Toxic Substances Control Act of 1978 (TSCA). In July of 1979 regu lations covering the manufacture, distribution In coamerce, use, mark ing, storage and disposal of PCBs became effective In the United States. The die casting Industry has used PCBs for many years In hydraulic fluids for safety reasons. Because PCBs are relatively non-fleasable, apparatus containing them Is essentially free from fire and explosion hazards assoclatad with usage In proximity to high temperature and open Ignition sources. Thus the die casting Industry Is particularly affected by the PCB regulations undar TSCA. This article will describe the use of flre-raslstant hydraulic fluids containing PCBs in tha die casting Industry and the actions taken, both by Industry and the government, after PCBs were discovered In the envlronnsnt In the late 1960's. The srticle also will discuss the current federal PCB regulatory framework and the latest studies assessing the possible environmental and human health effects of PCBs. MOMS 01*278 -1- 1. History And Usee Of PCB^S PCBs srs class of organic chemicals known as chlorinated aromatic hydrocarbons. They vsrs introduced into United States industry in 1929. Chemically, PCBe are composed of carbon, hydrogen and chlorine atona in various combinations (see Figure 1). H> a ci.. a. 5SJa my to 1 The unique chemical and physical properties of PCBs led to their widespread use. PCBs ere chemically Inert, stable end fire resistant, and they have a very low vapor pressure (BP ranges 275* - 425*0. PCBs function uniquely as dlclsctrlc insulators to act as non-conductors of direct electric current. Theae properties Bade then Ideally euited for electrical applications where high-voltage arcing could occur and could result In fires and/or explosions, daaage to equipment and significant hazards to health and life. Thus, since the early 1930's, PCBs have bean used in transforaars, capacitors, and other alactrical equipment. The fire-resistant nature of PCBs also nade than well-suited for use in hydraulic and heat transfer fluids. Industrial hydraulic operations began using PCBs for fire protection In the lata 1940's snd sarly 1950's. Usage Increased In typical Industrial applications where flra-realatant properties wars both desirable and necessary. PCB hydraulic use concen trated In primary metal production and matal working industries which utilized high temperatures and povar usage for producing and forming metals and related products. HONS 015279 -2- Hydraulic power la ueed extensively In Che basic steel and alualnua Industrial, In foundries, and la the primary means of transmitting large forces In die casting, forging and extrusion. Metal tempera tures In or near hydraulic equipment for such uses range from 800*F to 3000*F and the fire hazard Is severe. In addition to fire safety, PCB hydraulic fluids offered additional performance characteristics such aa lubricity, anti-rust and corro sion properties and favorable physical properties, e.g., vapor pressure and vlscoalty, to facilitate equipment design and operation. PCBs were also used In a variety of other industrial products, in cluding Items such as lubricants, inks, plasticizers, adhesives, coatings and carbonless copy paper. However, the bulk of all PCB sales were for electrical, heat transfer and hydraulic fluid appli cations. Monsanto Company entered the chlorinated biphenyl business in 1935 with the purchase of Swann Chemical Company and eventually became the major producer of PCBs In the United States. PCBs also were produced In a number of other countries and are still produced and used In many European countries. Crowing Awareness Of Potential Concerns Associated With PCBs The use of PCBs resulted in industrially superior products. Because of their widespread use they have been distributed throughout the environment. However, their persistent presence in'the environment waa unsuspected before the late 1960'. Scientific knowledge about the pretence of PCBs in the environment, and about Its possible significance, began to evolve during the late 1960's. That evolutionary process began with two events, one In Sweden and the other In Japan. HONS 015280 In Swedan, Soren Jenaen, tiling new analytical technology to lnveatlgata DOT realduaa In the environment, reported the poaelble preeence of PCIa In flah tlaeue. Following preliminary news media reports In late 1966, Monsanto and others began Insedlately to study the Swedish work. Before the findings could be confirmed or duplicated In the United Statea, analytical methods had to be refined In order definitively to separate PCBe from other chlorinated hydrocarbons that were known to be present in the environment. New techniques were required to enable reeearchers to detect and Identify these chemicals In the trace level rangea being reported. The advent and development of refined gas liquid chromatography analytical techniques during this time period and since have made routine analyaes In the part per billion (ppb) range possible. In Western Japan, In 1968, about 1,000 people became 111 ae the result of an unfortunate Industrial accident In which rice oil was contaminated with FCBs when a heat exchanger ruptured and leaked Into the food product The lllneeeee which cam to be known ae "Yusho" or rice oil disease, initially were biased on the presence of PCBs. Several years later, however, it has been learned that most, if not all, of the toxic Yusho effects were not caused by the PCBs but were actually caused by extraordinarily high trace levels of impurities in the Japanese PCB fluid. The presence of PCBs in the United States environMnt was confirmed by 1970, but little was known about their potential impact. Based on these early studies and reports, Monsanto voluntarily terminated sales of PCBs in 1970 for use in "open" applications, such as plasticizers and carbonless copy paper . Monaanto al*o advlaed food procaaaora ualng PCB heat cranafer fluid* Co change Co alternadve heating machoda. Monaanto re-eaphaelzed the need for improved monitoring of finlahed food producta to preclude contamination by any heat tranafer fluid. In 1971 Monaanto terminated all heat cranafer fluid aalea of FCBa, aubacltutlng ocher producta with equivalent thermal atabllity but leaa fire realatance. *0NS 015281 -4- Tha devalopmant of replacement hydraulic fluids also began In 1970. In 1970 and 1971 Monsanto contacted customers in various Industry segments, Including the die casting and metals producing Industries vho used PCS hydraulic fluids as well as other PCB formulations, to inform them of PCB environmental concerns. Monsanto alerted users of PCB hydraulic fluids to manage wastes In order to eliminate PCB discharges to the environment. As new hydraulic fluids were developed in 1971, sales of fluids containing PCBs were terminated. The only uses for which Monsanto continued to produce and sell PCBs were certain enclosed applications In the electrical Industry, Such as in capacitors and transformers. No suitable replacements for PCB dielectric fluid were available In the early 1970's. The electrical Industry and the government suggested that the benefits to society of continued chlorinated biphenyl dielectric use out weighed the low risk of uncontrolled releases from sealed applica tions. The Government's Interdepartmental Task Force on PCBs recom mended in their May, 1972 report chat "the use of PCBs should not be banned entirely." "Their continued use for transformers and capacitors In the near future Is considered necessary because of the significantly Increased risk of fire and explosion and the disruption of electrical service which would result from a ban on PCB use." They requested that Monaanto continue producing PCBs for these applications. In order not to stop the production of equipment essential to the safe and &efficient distribution and use of electrical energy Therefore* Monsanto agreed to continue supplying PCB products to manufacturers of electrical power distribution equlpaent for use only in capacitors* transformers and other sealed systems. In continuing to sell to such customers, however, Monsanto emphasised that the key to managing the risk waa sound malntanance practice and disposal control. Monsanto also raquired assurances chat the materials would be safely handled and properly disposed of. By 1977* replacement dielectric fluids were available, end Monsanto halted ell production of PCBs. (PCB manufacture and sales ware finally prohibited in July* 1979 by Federal regulations.) MONS 015282 -5- 3. Government Regulation Of PCBa In fch fall of 1971, the federal government established an Inter departmental Task Force on PCBa to study the environmental presence and health effects of PCBa. Among the Task Force recommendations was passage of a federal statute to restrict use and distribution of PCBa and to collect Information about their effects. Congress passed the Toxic Substances Control Act (TSCA) In 1976. The act singled out PCBs for regulation and authorized EPA to pro mulgate rules governing the disposal, marking, manufacture, pro cessing, distribution in commerce and use of PCBs. EPA'a final PCB regulations, published in July, 1979, are found in Title 40, Part 761 of the Code of Federal Regulations (CFR)In suaaury, the provisions: s Prohibit all manufacturing of PCBs unless specifically exempted by EPA. e Prohibit processing, distribution In commerce and use of PCBs except in a "totally enclosed manner." e Authorize certain processing, distribution in conmrct and use of PCBa In a non-totally enclosed manner. s Define marking, storage and disposal rules. Define recordkeeping requirements. s Establish a 50 parts per million (ppm) minimum PCB concentration for regulation. Of particular Interest to the die casting Industry are those provisions of the regulations dealing with the use of PCBs In hydraulic systems, as well as ths marking, storage, disposal and recordkeeping regulations. Provisions dealing with uses of PCBs In electrical transformers and capacitors also may be applicable to the die casting Industry. MGNS 015203 -6- The uee of PCBe la hydrtullc systems In a non-totally enclosed manner la apeclflcally authorized until July 1> 1984, provided the condltlono of 40 C.F.R. 8 761.30(e) are met. These conditions require initial sampling and analysis of all hydraulic systems that ever contained PCBs with subsequent flushing and draining of equipment. For each year that Cists indicate a PC8 concentretlon of at least 50 ppm, each hydraulic system must be drained and refilled with fluid containing less than 50 ppm PCBs. When the annual test Indicates that the fluid In a system contains less than 50 ppm PCBs, no further testing Is required. Thus the key checkpoint for hydraulic systems in the die casting industry Is the 50 ppm minimum cutoff level. The required sampling, analysis, draining and disposal of fluids. In addition to storage, marking and recordkeeping requirements, are very expensive. In many cases multiple drainings and flushings have failed to achieve PCB levels less than the 50 ppm regulatory cutoff level. There Is no known technology that will universally remove PCBs from hydraulic systems and will systematically achieve the required 50 ppm level by following a prescribed program. A major frustration of the industry Is the failure to understand why simple dilution techniques such as multiple drainings and flushings with fresh fluid will not achieve the mathematically calculated reduced PCB levels. The current regulatory scheme Is complicated by a lawsuit brought by the Environmental Defense Fund (EDF) against EPA, challenging the validity of the 1979 PCB rules. In a decision handed down In 1981, the United States Court of Appeals for the District of Columbia Circuit held that there was Insufficient evidence to support certain provisions of the regulations authorizing "totally enclosed" uses of PCBs. The court also found the evidence insufficient to support the 50 ppm regulatory cutoff level. The Court directed EPA to develop new PCB regulations but allowed the 1979 regulations to stand until such time as new PCB rules are promulgated. Thus EPA faces the task of establishing a new regulatory cutoff level and/ 7- MGNS 015284 or authorizing additional non-totally enclosed PCB uses at low PCB levela, auch aa In hydraulic syatens containing low but measurable PCB levels. This rulemaking procedure Is taking place at this time. Health Effects of PCBs Since Congress passed TSCA In 1976, much nev scientific Information has been published on the health effects of PCBs In both humans and animals. A search of the published literature Indicated that over 5,000 scientific and technical papers on PCBs have been published since 1976.0 Of particular significance are those reports relating to human expo sure or epidemiology studies. Within the last two years results of a number of published human PCB exposure studies have shed sig nificant new light on the PCB health effects issue. In addition, two Independent groups of scientists have recently re-reviewed the total body of PCB health and toxicity literature with particular emphasis on the human exposure studies. These reviews have been in conjunction with the new CPA rulemaking procedure required by the Court of Appeals in the EDF case. The Chemical Manufacturers Association (CMA) sponsored one group of reviewers, Ecology and Environment, Inc. (E&E), an Independent environmental consulting firm from Buffalo, New York. The E&E report was submitted to CMA and EPA in November, 1981 entitled "Summary of the Health Effects of PCB."0 A second Independent review of the PCB health effects and environ mental effects literature was sponsored by trade associations in the utilities and electrical equipment industries, Edison Electric Institute (E&E) and the National Electrical Manufacturers Association (NEMA). The EEI/NEMA study was performed by the firm Drill, Frless, Hays, Loomis and Shaffer, Inc., Consultants in Toxicology of Arlington, Virginia. The Drill, Frless et al report was submitted to EPA in February, 1982. o HONS 015285 The lndspendsnt conclusion* of both of these groups of scientists, which are supportive of and consistent with each other, aay be suaawrlzed as follows:GO (1) Current exposures Co PCBs generally do not pose any serious risk of injury to human healch. (2) PCBs are not human carcinogens* (3) PCBs have not been shown to affect human reproduction adversely or to cause birth defects* PCBs are not mutagens or teratogens. (4) The only proven adverse human health effects resulting from PCBs are two skin conditions, dermatitis and chloroacne, which are reversible after discontinuance of exposure. Ecology and Environment, Inc. (E&E) concluded in their report submitted to EPA that in its "Independent professional opinion that 'any exposure to PCBs' does not pose a significant health risk to humans." E&E con cluded "that PCBs do not represent a carcinogenic (genotoxlc/inltlator) risk and that, even if they possess oncogenic (epigenetic/promoting) activity, the risk at low exposures is insignificant." Recent epidemiological studies also have failed to find any serious health effects caused by exposure to PCBs. A 1981 study by the National Institute of Occupational Safety and Health (NIOSH) focused on 2,500 electrical equipment manufacturing workers who had been occupationally exposed to PCBs for several years. Many of the workers were routinely exposed to PCBs for over 10 years. The study found no excess In total mortality or in mortality due to cancer, cardiovascular disease or neurological disorders. A recent review by Dr. William Gaffey of Monsanto Company of epide miology studies published to date found that during occupational exposure, PCBs can cause temporary skin problems, but that there were HONS 015286 -9- no clinically observable long-tern human health effects. Including the occurrence of cancer. Studies of non-occupationally exposed populations found neither dermatitis nor other clinical evidence of exposure-relaeed effects. Many of the recent epidemiology studies Include data on large numbers of Industrial workers, who, over many years, were occupa tionally exposed to PCBs. In most cases, these were chronic occu pational exposure to PCBs at levels far greater than any reasonably foreseeable exposure level under existing regulations. The studies have shown that, like other chemicals, PCBs can cause dermatitis and chloracne, although these skin disorders were reversible after discontinuing the exposure. In spite of over 50 years of PCB use, no causal relationship has been established for any specific type of cancer, nor has it been proven that the incidence of cancer mortality has Increased due to PCB exposure. Environmental Levels Of PC3a Recent measurements of environmental levels do not support the con clusion that PCBs have exhibited a significant irreversible Impact on the ecosystem. In May, 1983, EPA released the results of a study showing "a sharp decline in the percentage of the U.S. population having levels of polychlorinated biphenyls (PCBs) above three parts per million In their fat tissue.' The study continued: Results of the National Human Adipose Tissue Survey (MHATS) conducted by the Office of Toxic Substances indicates that the estimated fraction of the national population having greater than 3 ppm of PCBs have decreased from 8 to 1 percent between 1977 and 1981 after increasing from 2.7 to 8 percent between 1972 and 1977. This indicates that exposure of the U.S. population to PCBs is decreasing. Data on PCB contamination of fish and natural bodies of water have shown that environmental levels are still decreasing at a significant rate. Levels in fish in three different areas of the United States (Great LakeJ G, New YorkC* Q and Alabama-GeorglaG) were in -10- MONS 013287 Che range of one to five ppm in 1980-81, as contrasted with levels ranging from 60 ppm in 1973 Co 18 ppm in 1975. In addition, recent publications have demonstrated that the more highly chlorinated PCB homologs are not as persistent as predicted. Although their persistence had been predicted to be on the order of a hundred years, one study has shown that their average persis tence Is in the range of 40-50 months. These data are based upon half-life values of PCBs in the tissues of environmentally exposed fish. Data published by the National Academy of Sciences In 19790 also have shown a significant reduction of PCB concentrations In the air over the North Atlantic Ocean. These data have demonstrated an order of magnitude decrease In PCB concentrations In the air ranging from 0.76 ng/m (0.55 ng/ta) In 1973 to 0.074 ng/m (0.099 ng/m) in 1977. These downward PCB trends are the result of voluntary industry actions taken in the 1970's to reduce usage of and possible exposure to PCBs. These responsible Industry actions were taken before the enactment of TSCA In 1976 and far earlier than the actual PCB regu lations in 1979. Recent studies indicate that PCBs are not human carcinogens and that while they may produce reversible skin conditions, they do not pose serious risk of Injury to human health. Also, as a result of volun tary efforts to reduce the use of PCBs, the level of PCBs in the environment continues to decrease. To preserve and continue these environmental Improvements, the die casting industry must continue to use special care in the handling of any Item containing PCB, including hydraulic machinery, capacitors, and transforswra. Good industrial hygiene work practices should be -11- HONS 015203 ployed by all workers who say coae Into conctact with PCBs. Although the regulatory environment governing PCBa la In a state of flux, regulations are In effect governing all aspects of the use, distribution In commerce and disposal of equipment containing more than 50 ppm PCBs. These regulations are detailed and require the die casting industry to continue to reduce the concentration of PCBs in hydraulic fluids. -12- HONS 015289 REFERENCES: 1. Toxic Substances Control Act of 1976, Public Law 99-469, October 11, 1976. 2. U.S. EPA - Polychlorinated Biphenyls (PCBs) Manufacturing, Processing, Distribution In Coaaerce And Use Prohibitions - U.S. Code of Federal Regulations, 40 C.P.R. 761 as published In Federal Register 44. Pages 31514-31568, May 31, 1979. 3. Hutzlnger, 0. et al - The Chemistry Of PCBs - CRC Press,'Inc., Boca Raton, Florida, 1974. 4. Jensen, Soren - "Report Of A New Chealcal Hazard" - New Scientist. 32, 612 (1966). . 5. Saekl, S. et al - Fukuoka Acta Med. - 62, 20 (1971), Chealcal Abatract 74. 146294 (1971). 6. Versar, Inc. (Consultants) - "PCBs In The United States - Industrial Use And Envlronaental Use" - U.S. EPA Final Report, EPA 560/6-76-005, February 25, 1976, Page 2. -- 7. Interdepartaental Task Force On PCBs - "Polychlorinated Biphenyls And The Environment" - May 1972, Washington, D.C., National Technical Inforaatlon Service COM-72-10419, Springfield, Virginia. 8. Envlronaental Defense Fund Vs. Enylronaental Protection Aaencv 636 F 2d 1267 (D.C. Circuit 1980). 9. Anonyaous - "The Specter Of Tougher PCB Rules" - Chealcal Week. January 14, 1981, Page 49. 10. Chealcal Manufacturers Association (CMA) - "Consents In Response To Two Advsnce Notices Of Proposed Ruleaaklng Relating To The Manufacture Of PCBs Below 50 Parts Per Million" - Published May 20, 1981, by the Envlronaental Protection Agency (46 Federal Reg. 27617, 27610). Subaltted to U.S. EPA Novenber 25, 1981. EPA Docket Nos. OPTS-62013 and OFTS-62014. 11. Gaffey, W. R. - "The Epldealology Of PCBs" - Presented at 182nd Aaarlcan Chealcal Society National Meeting, Dlv. of Chealcal Health and Safety, Symposium on Epldealology, August 1981, Abstract Paper No. 46. 12. Ecology and Environment, Inc. (Consultants) - "Sunsnry Of The Health Effects Of PCBs" - Prepared for the Chemical Manufacturers Association November 1981 (subaltted to U.S. EPA Novenber 1981, sec Reference 10). MOMS 015290 1 13. Drill, Fries*, Hay*, Loomis 6 Shaffer, Inc. (Conaultanta In Toxicology) "Potential Health Effect* In The Humana from Expoaure To Polychlorinated Biphenyl* (PCB*) And Related Inpurltlee" - Prepared for The Utility Solid Haate Activities Croup, The Edison Electric Institute et al, January 23, 1982 (submitted to U.S. EPA February 12, 1982). 14. Brovn, D. P. and Jones, H. - "Mortality And Industrial Hygiene Of Workers Exposed To Polychlorinated Biphenyls" - Arch. Environmental Health 36, 120-129 (1981). 15. Lucas, R. M. et al - "Polychlorinated Biphenyls In Human Adipose Tissue And Mother's Milk" - Research Triangle Institute, North Carolina November 12, 1982 (RT1/1864-30-03F) prepared for the U.S. EPA National Human Adipose Tissue Survey (NHATS). Released by U.S. EPA May 9, 1983 Washington, D.C. 16. Anonymous - "PCBs: They'll Be With Us Awhile" - National Resources Register, Volume 2 January 1982, Page* 8-9. Published by Michigan Department of National Resources, Lansing, Michigan. 17. Linda Welsner, "PCBs In Fish: The Worst May Be Over," Great Lakes Conmunicator, Volume 11, December 1980, Page 3. Published by the Great Lake* Basin Commission. 18. J. McGuire et al - "1980 Report On Great Lakes Water Quality," Great Lakes Water Quality Board Report to the Intematlonel Joint CosmilsBion - Canada and the United States, November 12, 1980, Toronto, Canada. 19. R. Armstrong and R. Sloan - "Trend In Levels Of Several Known Chemical Contaminants In Fish From New York State Water." New York State Department of Environmental Conservation, Technical Report 80-2. 20. Anonymous - "Research On PCBs In Aquatic Ecosystems," SF1 Bulletin No. 302, March 1979, Pages 1-2. Published by The Sport Fishing Institute, Washington, D.C. 21. Committee on the Assessment of Polychlorinated Biphenyls In the Envlronawnt - "Polychlorinated Biphenyls" - National Academy of Sciences, Washington, D.C. (1979). HONS 015291 11 OBSERVATION AND CONCLUSIONS BASED ON A STUDY ON THE HEALTH OF CAPACITOR WORKERS WITH HIGH PRIOR EXPOSURE TO PCBs PRESENTATION AND DISCUSSION BY: GENERAL ELECTRIC COMPANY J.F. Brown, Jr. S.B. Hamilton, Jr. R.W. Lawton July 11. 1983 MOMS THE HEALTH OF CAPACITOR WORKERS WITH HIGH PRIOR EXPOSURE TO PCB's: A Clinical Cross-Sectional Study General Electric Company Corporate Environmental Program R. Lawton, M.H. fl. Ross, R.N. J. Feingold, R.D. J. Brown, Jr., Ph1*. NONS 015i93 OBJECTIVES OF STUDY 1. Characterize health status of exposed population * OVERALL ASSESSMENT (HISTORY, PHYSICAL) * 75 QUANTITATIVE PARAMETERS 2. Characterize exposure levels * JOB ANALYSIS AND CATEGORIZATION * PCS AIR LEVELS * SERUM PCB MEASUREMENTS * ACTIVITY INDICATORS * PCB BODY BURDEN 3. Assess health effect - exposure correlation * CHECK REPORTED CORRELATIONS * LOOK FOR NEW ASSOCIATIONS AMONG VARIABLES HONS 01529* SIGNIFICANT BACKGROUND FACTORS (6E Hudson Falls / Fort Edward PCB Exposures) * Largest U.S. PCB User (151! of total PCB consumption (1966-1974) * Composition of PCB's used * 95X OF PRODUCTION Aroclor 1254: Aroclor 1242: Aroclor 1016: 19*6-1952 1952-1971 1971-1977 * Defineable exposed population * Long continuous service * Many with heavy exposure * Best opportunity to define actual effects of PCB exposure in human HONS 015295 1000 (679 /WMIMffV CD 2|00b s K> i 1975 1976 1977 1978 1979 1980 __________ I 1981 MOhS 0 1 5 2 9 6 MULTIPLE PRIOR INVESTIGATIONS * Fischbein, Selikoff et al^ * Marshak, Selikoff et al l Mt. Sinai * Wolff, Selikoff et al j * Brown et al : N10SH, Cincinnati, Ohio * Taylor: MYSDH, Harvard School Public Health Brown, D.P. and fl. Jones. Mortality and industrial HY6IENE STUDY OF WORKERS EXPOSED TO POLYCHLORINATED BIPHENYLS. Arch. Environ. Health 120-125, 19P1. Fischbein, A., Wolff, P.S., Lius, R., Thornton, J., and I.J. Selikoff. Clinical findings among PCB-exposed capacitor workers. Ann. N.Y. Acad. Sci. 220: 703-715, 1979. Marskaw, R., Fischbein, A., Thornton, J., Miller, A. and I.J. Selikoff, Decreased vital capacity in PCB-exposed workers in a capacitor manufacturing facility. Ann. N.Y. Acad. Sci. 22Q-. 277-284, 1979. Wolff, M.S., Fischbein, A., Thornton, J., Rue, C., Lilis, R. and I.J. Selikoff. Body burden of polychlorinated biphenyls among persons employed in capacitor manufacturing. Int. Arch. En viron. Health S2: 199-208, 1982. Wolff, M.S.m Thornton, J., Fischbein, A., Lilis, R. and I.J. Selikoff. Disposition of polychlorinated biphenyl congeners in occupationally exposed persons. Toxicol. Appl. Pharmacol. 2.i 294-306, 1982. HONS 015297 HEALTH STATUS ANALYSIS * Study population and selection * Clinical measurements * Medical findings HONS 015298 DESCRIPTION OF SE STUDY POPULATIONS 1976: Directly exposed capacitor morkers (' 10* OF workforce) 1979: Repeat study 1981: Small group studies * H16H EXPOSURE * CLERICAL AND ADMIN. * NEW EMPLOYEES SINCE 1977 (HIGH EXPOSURE ZONE) 19*1 17*1 12 IS 16 HONS 015299 Population Selection (199) * Based on current exposure (1976) * CONTINUOUS IN H16H EXPOSURE ZONE * CONTINUOUS IN PERIPHERY | J* INTERMITTENT HI6H EXPOSURE Plant PCB Use and Employment Date 1996-1959: Aroclor 1959-1971: Aroclor 1971-1977: Aroclor 1259 12*2 1016 Ht. Sinai School op Medicine Study (Fischbein et al) 1976 : volunteers 1979 : repeat study * WORKERS IN COMMON * ADIPOSE TISSUEBIOPSY No. 55 jjg 51 93 50 326 33 61 HONS 015300 Nmtatlw ni ftnwri ,M> M iut riant Bx/non-B Dtsaaaa ItitM Blood BCB 1242 1254 12*0 BBC Bnp. Bat. Mr KB Mt. Sinai Paat/non-Past tH7*) Metabolic Baiponaoa (10) Reiyht Prana Pra-enpl. at. Body Ot.(T4 a 79) Mas. Saf. at. Body at/naight* Triglycerides Cholesterol Blood Sugar Uric Acid Cardloaaaeolar (3) ecc Blood Prasaore Systolic Diastolic HONS 0 1 5 3 0 1 I wasatlo Raeponeaa mi Total Billrobin Diract Bllirwbin SOOT SOFT CGTP Altaiina Pttoaph. UNI Total Protaln Albunln Globulin A/C Ratio Anylass Banal Responses US) Bun craatinina Bun/Creat. Ratio Ha* R* Pb* Mg** Urinalysis Appearance pH Sp. Gr. Acetona Albunln Glucosa PRC one Casts Sanatoloop mi Iron RGB Dlffarantial Rolys Lynpha Monas Eoalna Baso. Rulnonarr function PVC ni PBTj/fK Chaat x-ray (4) History (5) Sacking Alcohol use Drug use Diaynosis Surgery Symptomatology (i) Dansatoloyical Neurological Cardiovascular Resp)ratnry Gastrointestinal Musculo Skeletal T Clinical Findings in PCB-Exposed Capacitor Workers 1. Dermatological Findings Medical record review (1970-1975) 1509-1^00 Now-Exposed Employees N' Skin irritations or dermatitis Occupationally related Non-occupational Medical record review (1960-1975) PCB-Exposed Employees Contact dermatitis to dielectric PLUID Nausea, dizziness, eye and nasal IRRITATION, ETC. ON SHORT INITIAL EXPOSURE Medical History of Study Population Rash PCB-related Seborrhea Infections Eye complaints Old acne Other 1 Chloracne not observed Plant Physician 70(9.27) IE (237) 59 ^ 16 95 12 19 7 9 13 HONS 015303 Clinical Findings in PCB-Exposed Capacitor Workers (cont.) 2. Chronic Obstructive Lung Disease * Restrictive patterns (3) 1.83 Obstructive patterns (26) 15.37 Mixed patterns (3) 1.87 * 657 of population smokers or x-smokers 3. Obesity * 507 of population overweight * Many obese by any standard i|. Hypertension * History of hypertension 22.77 * Diastolic BP * 90 14.7 * 19.67 since employ 5. 6lucose Intolerance * 45 cases (207): 5 diabetics, 10 others 30 NORMAL POST PRANDIAL 6. Elevated Cholesterol Levels * 1976 - 417; 1979 - 297 using LRCP age adjusted percentiles * Incidence of gallstones, fatty food intolerance, etc. 107 * Triglycerides 1976-93 : 1979-187 7. Other biochemical variables in normal ranges except S6PT HONS 015304 3. Statistical Association Between Health Status Indicators and Measures of PCB Exposure * Statistical procedures used * Correlations observed * Comparison of findings nith others * Conclusions MONS 015305 Statistical Procedure: Multiple Linear Regression * Examine variable distributions * LOG TRANSFORMATION AS REQUIRED * W-TEST OF DISTRIBUTIONAL ASSUMPTIONS Select confounders ... - .-- * 4 BODT-PAT, SEX, SERVICE TIME * Test each variable for dependence on PCB's AND CONFOUNDERS: (varI) A B(var2) C(var3)+ ......... DEPENDENT VARIABLE INDEPENDENT VARIABLES * Statistical Criteria MODEL : F > \IW; DF * 100-170 COEFFICIENTS: 957- CONFIDENCE INTERVAL f 0 HONS 015306 TWO MEASURES OF PCB LEVELS USED 2. 6ROSS PCB CONCENTRATION IN SERUM * (weight PCB) / (height serum) 2< Chemical activity of PCB's (*) * (height tissue PCB) / (weight tissue lipid) * At equilibrium, a toxicant must reach same CHEMICAL ACTIVITY (ft) IN ALL TISSUES OF THE BODY, INCLUDING ANY SITES OF PHARMACO LOGICAL action. This activity function CORRELATES WITH TOXIC EFFECT. Ferguson, 1939 HONS 015307 PCB EQUILIBRIUM IN BODY * NO EVIDENCE OF ACTIVE TRANSPORT * Equilibrium established within days a PCB carriers in serum have been IDENTIFIED: - PRIMARILY, NEUTRAL LIPID (NL) MICROPHASES OF SERUM LIPOPROTEINS - SECONDARILY, ALBUMIN (Alb) * Equilibrium between adipose tissue (A) and serum (S) PHASES DEFINED BY CHEMICAL ACTIVITY <1: ' Literature data indicate mean values of N*close TO 1.0, IF [nl]s be expressed as sum of serum trislycerides plus cholesterol, or as extractable LIPIDS. NON5 01530a Results of Linear Regression Analysis * Significant associations among observed clinical findings * obesity, hyperlipidemia, hypertension, etc, * SMOKING AND PULMONARY FUNCTION * Only three clinical measurements correlated WITH 6R0SS SERUM PCB CONCENTRATIONS * SERUM TRIGLYCERIDES * SERUM TOTAL CHOLESTEROL * SERUM Y-6LUTAMYL TRANSPEPTIDASE * Similar correlations reported previously HONS 015309 Association op Clinical Indicators with Serum Level and Pharmacological Availability or Lipophilic Agents MLeipaosuprheiloicf MINT - *> enMc.m serum Aroclor 1242 Aroclor 1260 m 156 126 156 Clinical Measurement TRI6LYC. Choi. GGTP 44 4 N.S 4 N.S Chemical Activity Aroclor 1242 Aroclor 1269 m 156 126 156 M.S. N.S. N.S. N.S, N.S. N.S. N.S. N.S. * controlled for sex, service, sp. gr. (urine) HONS 015310 Clinical Parameters Significantly Associated with Gross Serum PCR Concentrations in PCB-Exposed Populations Author (PCB) Clinical Neasurement 11 Tri Present study Chase et al (1291) Smith et al L-PCB * H-PCB Barer et al (1291) Itero et al (CRD H.S. Chol H.S. WTP H.S. R.S. (dtMrnil SCOT N.S. . N.S. SGPT N.S. n.s. N.S. N.S. HDLC 1 N.S. N.S. <-) - N.S. (-) N.S. 1 HONS 015311 A/ SUMMARY * Resonably urge popuution nith high prior OCCUPATIONAL EXPOSURE TO PCB'S * Health problems op the popuution are those of the modern affluent American workerj EiGk obesity, hyperlipidemia, hypertension, SMOKING * The statistical associations between gross SERUM PCB CONCENTRATION and serum lipids AND LIVER ENZYMES FOUND TO BE THE CONSEQUENCE OF PCB EQUILIBRATION BETWEEN SERUM LIPOPROTEIN AND ADIPOSE TISSUE RESERVOIRS OF NEUTRAL LIPIDS [PCB3a tPCB3s tNUA fc'CNUs HONS 015312 DESCRIPTION AND COMPARISON OF PCB EXPOSURE LEVELS John F. Brown, Jr. Richard W. Lawton, n.D. General Electric RtP Center PO Box 8, Schenectady, NY 12301 HONS 015313 TOPICS TO BE DISCUSSED 1. Reporting of PCB analytical data 2. Estimation of cumulative uptake and clearance 3. Calculation of body burdens <1. Human vs. animal uptake comparisons 5. Capacitor vs. other occupational exposure 6. Ambient PCB levels in capacitor manufacturing vs. current environments HONS 015314 AftOCLOft 1242 N mi AftOClO* 1194 IKS AAOCiOA 12*0 I s * B mis et llAt A/VA -- (4M/WC wema' kmjm sx HONS 015315 HONS 015316 fMU XI. Altarnative Nays of Reporting Sana Analytical Data on PCB Lavala in Capacitor Worker' Sara Aeportable PCS Aggregate Daacription Peak Number* *2-4 Cl-BP %S-6 Cl-BP V7-8 Cl-BP Total LKB'a HPCB'a Total Aroclor 1016 Aroclor 1242 Aroclor 1254 Aroclor 1260 Total 11-70 78-197 222-528 11-528 11-98 104-528 11-528 11-70 11-146 47-244 70-528 11-528 Reportable Parameter (PPb) Actual PCB'a present Analy- tical "Aroclor" Minimum Initial cone. 195 1739 101 - 166 7_ 7 373 I5T7 237 1807 66 - 105 373 T5T3 . 1314 1000 452 150 127 - 93. 19 373 1773" I3TJ a. Sum of value* for "Aroclor 42" and "Aroclor 1260 HONS 015317 PCB EQUILIBRIUM IN BODY * NO EVIDENCE OF ACTIVE TRANSPORT * Equilibrium established within days * PCB CARRIERS IN SERUM HAVE BEEN IDENTIFIED: - PRIMARILY/ NEUTRAL LIPID (NL) MICROPHASES OF SERUM LIPOPROTEINS - SECONDARILY/ ALBUMIN (Alb) * Equilibrium between adipose tissue (A) and serum ($) PHASES DEFINED BY CHEMICAL ACTIVITY ft: . [PCBjs [NLJs + K[AlbJs fPCBi s *[nl] s * Literature data indicate mean values of close to 1.0/ if [NL]S be expressed as sum of serum TRIGLYCERIDES PLUS CHOLESTEROL/ OR AS EXTRACTABLE LIPIDS. NONS 0153i8 PCB Levels in Workers Directly Exposed (19**6-1977) (N - 12) PCB's Present (1981) Serum Tissue (est.) Body Burden (22 KG PAT) Mean 303 ppb 99.9 ppm 1.0 GRAM Range 150-950 23-67 0.5-1.5 Minimum Initial Concentrations and Uptake Serum Tissue (est.) Uptake 1912 ppb 277 ppm 6.1 grams Minimal Clearance 89Z 925-2775 136-902 3.0-8.8 HONS 015319 Comparisons Between PCB Uptakes in Directly Exposed Capacitor Workers and Animals Used in Chronic Toxicity Testing Lower PCB's (Aroclors 1016, 1242) Minimal toxic dose in rats * Minimum uptake in directly- EXPOSED CAPACITOR WORKERS > 4. 6/kg 0.1 G/K6 Higher PCB's (Aroclor 1260) Producing hepatocarcinoma in rats *> Uptake in directly-exposed capacitor WORKERS 1.6 g/kg 0.003 6/KG . Burse, Kimbrough et al., 1974; Goldstein, 1975 6. Kimbrough et al. 1975 HONS 015320 REPORTED ABSENCE OF CONSISTENT HEALTH EFFECTS IN INDIVIDUALS OCCUPATIONALLY EXPOSED TO PCB's USED AT MODERATE TEMPERATURES Australia Ouw et al, 1976 Finland Karppanen and Kolho, 1972 Italy Maroni et al, 1981 Japan Hasegawa et al, 1972 Hara et al, 1979 Kitamura et al, 1973 Fischbein et al, 1979 Brown and Jones, 1981 Smith et al, 1982 Harshaw et al, 1979 Chase et al, 1982 Lawton et al, this study HONS 015321 OBSERVATIONS OF HEAVY PCB EXPOSURE IN CAPACITOR WORKERS Ambient PCB or "Aroclor" levels 100-1000 ug/m^ Serum PCB or "Aroclor" levels 100-1000 ppb Hasegawa et al> 1972 Kitamura et al, 1973 Fischbein et al, 1979 Smith et al, 1932 Karppanen and Kolho, 1972 Ouw et al, 1976 Karoni et al, 1981 Lawton et al, this study HONS 015322 US PCB USAGE AND OCCUPATIONAL EXPOSUPF 1930-75 Applications Low Temperature Uses Capacitors Transformers Miscellaneous (HP lbs) 630 335 163 Total 1228 Est. No. Individuals Exposed Peripherally Directly 32, m 0600 -- -- -*5,000 *000 High Temperature Uses Heat Exchangers Miscellaneous 20 5 25 - -'1300 - - *00 HONS 015323 CONCLUSION 1 1930-1977 OCCUPATIONAL EXPOSURES TO PCB'S WERE WIDESPREAD * Capacitor manufacturing * Transformer manufacturing and service * Plasticizer and printing ink users * Many thousands directly exposed HONS 015324 CONCLUSIOf! 2 1930-1977 OCCUPATIONAL EXPOSURES TO PCB'S HERE HIGH * Ambient air levels * Uptake rates * Retained PCB's HONS 015325 PAST AND PRESENT ENVIRONMENTAL PCB LEVELS ng/m* Capacitor manufacturing (1955-77) Capacitor manufacturing (1979) ''1,000,000 30,000 Binghamton office blog, after disruption OF PCB TRANSFORMER (1993) 800 to 1,600 Vault containing PCB transformers (1982) 700 to 900 Air near paper recycling mill (1977) E to 120 Air in PCB-using laboratory (1977) 00 to 50 Air in office using Datascreen Terminals (1982) 56 to 81 Outdoor air, Norway, 1992 0.5 to 1 Conclusion 3 In view of past PCB exposure levels and uptakes in capacitor WORKER POPULATIONS, PRESENT ENVIRONMENTAL LEVELS PRESENT LITTLE CAUSE FOR CONCERN. HONS 015326 PROPOSITION Yusho incidents don't predict health effects RESULTING FROM ORDINARY* LOW TEMPERATURE PCB USAGE * Different chemical composition * Different identified toxicant * Health effects not seen in other exposed populations HONS 015327 COMPOSITIONS OP PCB MIXTURES PRESENTED TO HUMAN STUDY POPULATIONS US Capacitor Workers Mainly lower PCB's (Aroclors 1016, 1242) Some higher PCB's (Aroclor 1254) PCDF/PCB 0-2 ppm US Transformer Workers Mainly higher PCB's (Aroclors 1254, 1260) Some lower PCB's (Aroclor 1242) PCDF/PCB 0-5 ppm Japanese Yusho Victims Pyrolysed lower PCB (Kanechlor h9P) *50X PCO, PCBP, PCDF, etc. PCDF/PCB 2250 ppm MOMS 015328 US PCB USAGE AND OCCUPATIONAL EXPOSURE 1950-75 Applications Lon Temperature Uses (MT lbs) Capacitors 630 Transformers 335 Miscellaneous 163 Total 1228 Est. No. Individuals Exposed Peripherally PlRECTLY 32,000 0690 -- -- ''65,000 'MOO Kish Temperature Uses Heat Exchangers Miscellaneous 20 5 25 - *'1300 - '200 HONS 015329 REPORTED OBSERVATIONS OF CHLORACNEGENIC DISEASE IN INDIVIDUALS EXPOSED TO PCB's USED AT HI6H TEMPERATURES Occupational Chloracne (appearing in high proportion OP EXPOSED WORKERS) Yusho Disease * Primary toxicant identified as 2,3,4,7,8-pentachloroD1BENZ0FURAN PUCCINELLI, 195* Meigs et al, 1954 Hofman et al, 1962 Birmingham, 1964 ^0 Japanese papers, 1969'10 Taiwanese papers, 1940' Masuda et al, 19P2 MOMS 015330 COMPARISONS BETWEEN YUSHO VICTIMS AND CAPACITOR WORKERS IN PCB AND PCDF UPTAKE Total Accumulation PCB's (g.) PCDF's (mg) Yusho Victims Minimum Mean Toxic Dose Dose Directly Exposed Capacitor Workers 0.63 0.11 3.a 0.6 >6 <0.01 . Assuming 2 ppm PCDF in PCB absorbed HONS 015331 COMPARISONS BETWEEN YUSHO VICTIMS AND RATS IN PCB AND PCDF UPTAKE Substance Loner PCB's (o./kg) Nixed PCDF's (vg/kg) Ninimum Toxic Dose Yusho Victims Rats 0.002 11 > it () '10 (>) a. GOLDSTEIN, 1975 t>. Oishi / 197ft HONS 015332 PROPOSITION Yusho incidents don't predict health effects RESULTING FROM ORDINARY, LOW TEMPERATURE PCB USA6E * Different chemical composition * Different identified toxicant * Health effects not seen in other exposed populations MONS 015333