Document baOk5e0GLrp5790Jdx29MZME6

FILE NAME: Georgia Pacific (GP) DATE: 1977 June 3 DOC#: GP056 DOCUMENT DESCRIPTION: US Consumer Product Safety Commission Memo with Attached Document Addressing the Toxicological/Medical Input for Proposed Federal Register Notice on Asbestos I PLAINTIFF'S i EXHIBIT [ GP-152 UNITED STATES GOVERNMENT Mem orandum U.S. CONSUMER PROOUCT SAFETY COMMISSION WASHINGTON. D.C. 20207 to THRU r o m : Don Clay, AED for Health Sciences oats: June^.3, 1977 : Robert Hehir, Deputy AED for Health Sciences jtJ* ^ Joe McLaughlin, Director, Division of Toxicology and I4eaiciner^\- : Rita Orzel, Ph.D., Division of Toxicology and Medicine C. T. Desmond, M.D., Division of Toxicology and Medicine^^i l m c t : Toxicological/Medical Input for proposed Federal Register Notice on Asbestos The Toxicological/Medical input on asbestos is presented in the attached document as a suggested CPSC Federal Register Notice for Asbestos. We recognize that this is not the usual format for presenting such material. The time constraints were 6uch that, for the sake of expediency, utilization of research background .material previously prepared by OSHA, Federal Register Notice, Occupation Exposure to Asbestos, Vol 40, No. 197, page 17652-665 v:as used as the basis for this document. This was determined to be the best method for accomplishing our assignment. ATE/ PROD NtnmumAh I. BACKGROUND A. General Asbestos is a generic term used to describe a number of naturally occuring fibrous, hydrated mineral silicates that differ in chemical composition. These may be divided into two mineral groups; (1) Serpentines, which include chrysotile (3MgO2Si02*2H20), the type most widely used in U.S. industry; and (2) amphiboles, including amosite (PeMg) Si03), crocidolite (NaFe(Si03)2*FeSi03*H20), tremolite (Ca2Mg5Sig0(0H22)2) anthophyllite (MgFe)?Sig022(OH)2, and actinolite (CaO*3MgFe)0*4Si02). Asbestos fibers are generally characterized by high tensile strength, flexi bility, heat and chemical resistance, and favorable frictional properties, certain grades of asbestos can be carded, spun, and woven, while others can be laid and pressed to form paper, or used for structural reinforcement of materials such as cement, plastic, and asphalt. Chrysotile (white asbestos) is the fibrous form of the mineral serpentine. It is the most common variety of asbestos, widely distributed geographically, with the largest deposits being in Canada, Russia, and Rhodesia. It accounts for over 90 percent of world consumption. Chrysotile can be readily crushed or fiberized into fine, white, silky fibers which may be processed into numerous products. The fibers have good heat resistance, but are destroyed by acids. Crocidolite (blue asbestos) is another A important, HT?' PROD although more specialized, form of asbestos. 2 It is the fibrous form of riebeckite, and has fine, re silient fibers of a characteristic blue color. It is mined in South Africa and Australia, and to a lesser extent, in Bolivia. Crocidolite is a strong, fast filtering fiber used especially in the manufacture of asbestos cement sheets and pressure pipes. It is also characterized by its high resistance to acids. Amosite is the fibrous variety of the mineral grunerite, a ferrous magnesium silicate mined only in South Africa. Amosite can be readily broken down into long, somewhat harsh fibers, with a brownish-yellow to almost white color, depending upon the quality. It is used largely in the production of asbestos cement and heat-insulating products. It is characterized by a good resistance to acids and other chemicals. Anthophyllite is a magnesium silicate of somewhat variable composition which has rather fragile, brownish or off-white fibers. It is rarer than other types described, but signi ficant quantities have been mined in Finland, Kenya, and other countries. It is used primarily as an inexpensive filler, and for some specialized applications for which good heat or chemical resistance is required. Treaolite, a calcium magnesium silicate, may be a component of industrial and commercial talc. It is mined in various parts of the United States including New York, Vermont and Montana. X Actinolite, a calcium magnesium iron silicate, is rarely used in industry. It is found in various parts of the world, but its low fiber strength makes it less desirable for industrial use. Nearly one million tons of asbestos are consumed in the United States annually. According to the Bureau of Mines Mineral Yearbook, 1973,approximately 77 percent of asbestos products consumed in 1972 were used in the construction industries (624,000 short tons) while 23 percent are used in. non-construction industries (186,000 short tons). Approximately 92 percent of the asbestos used in construction is firmly bonded, i.e., the asbestos is "locked in" in such products as floor tiles, asbestos cements, and roofing felts and shingles; while the remaining 8 percent is friable or in powder form present in insulation materials,-asbestos cement powders, and acoustical products. These latter products generate more airborne fibers than the firmly bonded products. The 186,000 short tons of asbestos used in the non-construction industries in 1972 were utilized in such products as textiles, friction materials including brake linings and clutch facings, paper, paints, plactics, roof coatings, floor tiles, and miscellaneous other products. II. TOXICOLOGICAL CONSIDERATIONS OF EXPOSURE TO ASBESTOS A. EFFECTS OF ASBESTOS EXPOSURE Asbestos, in its several commercial forms,* has been shown 4 of a variety, of disease entities. These include: 1. Asbestosis: a diffuse, interstitial, nonmalignant, scarring of the lungs; 2. Bronchogenic carcinoma: a malignancy of the in terior of the lung; '3. Mesothelioma: a diffuse malignancy of the lining of the chest cavity (pleural mesothelioma), or of the lining of the abdomen (peritoneal mesothelioma); 4. Cancer of the stomach, colon, and rectum. Asbestos may be evident, in its advanced stages, by charac teristic manifestaions on x-ray films, by restrictive pulmonary function, or by clinical signs, of finger clubbing or rales (dry, cracking sounds within the lung). Its most important symptom is dyspnea, or undue shortness of breath. The disease is progressive, even in the absence of further exposure, as those inhaled fibers which have been trapped within the lung continue their biological action. In its severe forms, death results from the inability of the body to obtain requisite oxygen or from the heart's failure to pump blood through the scarred lungs. Mesothelioma tumors are diffuse and spread rapidly throughoi the cavity of origin. They have yet to.be' successfully by am^styae, ofc-t W A Y scnl tion,lpr sfixgdlry. year of diagnosis. It ly re!iul:s()wi nt 'fSr one Trea eral onmental or occupational 5 asbestos exposure. In some groups of asbestos workers, it may account for one death in ten. Once established, the other asbestos associated cancers differ little from those occuring in the general population, although there may be variations in the location of the primary site* Appropriate treatment and prognosis follow for the particular tumor. There is very limited long term survival from lung cancer therapy; and only somewhat better from treated cancer of the colon or rectum. Asbestosis and asbestos cancer whether it be lung cancer, pleural mesothelioma, peritoneal mesothelioma, cancer of the stomach, colon, rectum-usually do not become clinically . evident until more than 20 years have passed from onset of exposure. This time-interval is now widely recognized. While some such cancers may appear during the second decade following onset of occupational exposure, peak incidence is often not noted until the 30-years-from-onset point, or later. This is true both with regular, long-term, brief or intermittent exposures. While variations in the time of occurrence may depend upon intensity and duration of exposure, with heavier exposure often being associated with shorter latency periods, variations among individual cases make it impossible to predict the latency period for the risk of any particular person. B. RECENT DOCUMENTARY EVIDENCE OF OCCUPATIONAL EXPOSURE (1) Asbestosis. Subsequent to the hearings on the 6 current Occupational Safety and Health Administration (OSHA) standard, uncertainty has arisen as to whether the existing British asbestos standard and the mandated 2 fiber/ml U.S. standard provide .effective protection even against asbestosis. The data from Great Britain obtained in 1966 indicated that little clinical disease, including x-ray evidence of asbestosis, had occurred among workers first employed in that factory at some time after 1933, when important improvements in work practices had been achieved. In 1972, results of evaluation of new x-rays that had been taken in 1970, of the work force then employed in the same factory, were reported as showing that many now had abnormal findings either in the lung or in the coverings of the lung pleurae (Lewinsohn, 1972). There was thus a difference between the prevalence of abnormal xrav findings among workers x-rayed in 1966 as reported to the British Occupational Hygiene Society, and evaluation of other x-rays of workers in the same factory four years later. Additionally, clinical data are becoming available concerning asbestos lung scarring in individuals exposed at levels much lower than those of occupa tional circumstances. Among 210 family contacts of former asbestos factory workers, 381 have been re ported to have x-ray changes characteristic of asbestos exposure (Anderson, Selikoff, Lilis and Daum, 1975). (2) Cancer. In December 1972, important new'information on the spectrum of asbestos cancers was presented 7 at the Conference on the Biological Effects of Asbestos, sponsored by the International Agency for Research on Cancer of the World Health Organization. At this conference, and subsequently, data on large groups of asbestos workers became available (Sclikoff, Hammond and Seidman, 1973; Enterline, de Coufle and Henderson, 1972). As expected, the high risk of bronchogenic carcinoma and mesothelioma persisted among factory employees and insulators. Moreover, these later studies confirmed the excess gastrointestinal cancer that had been suggested earlier, and extended the spectrum of asbestos related cancers. (a) Lung cancer. The most important cancer afflicting asbestos workers is cancer of the lung, although mesothelioma nets ctLLiacLeu considerable attention because of the high frequency among asbestos workers and infrequent occurrence in the population as a whole. In many groups of asbestos workers, approximately 20% of all deaths are caused by lung neoplasms. This has been true both among asbestos product factory workers (Selikoff, Hammond and Churg, 1972; and Nicholsor 1976) and among users of these products (Selikoff, Hammond and Seidman, 1973). The exact percentage varies with circumstances of exposure, age of the workers, duration of the workers' exposure and, and perhaps most of all, according to the^duration from the onset of their asbestos work history. In addition, \ of lung cancer among asbestos workers. In 19G8, Selikoff, Churg and Hammond reported that lung cancer was not significantly increased in incidence among asbestos workers with no history of cigarette smoking, although when such history was present, the incidence of lung cancer increased markedly over what would be expected among other cigarette smokers, in the absence of asbestos exposure. Thus, these scientists calculated that an asbestos worker who smoked cigarettes had 92 times the risk of dying of lung cancer, as compared with like individuals without cigarette smoking or asbestos work. This finding has been confirmed by larger studies (Hammond and Selikoff, 1973) where, again, it was found that non-smoking* asbestos workers had few lung cancers while those who smoked had much more lung cancer than would have been expected had they not been asbestos workers. Calculations suggest that cigarette-smoking asbestos workers have approximately eight times the risk of developing lung cancer compared to other smokers. (b) Pleural and peritoneal mesothelioma. In 1960, Wagner, Sleggs and Marchand demonstrated an important association between asbestos exposure and pleural mesothelioma. This cancer, which appears to be un related to smoking, had previously been considered to be a very rare tumor. Numerous reports have confirmed the finding of Wagner and his colleagues that raesothelior can be commonly associated with asbestos exposure. A subsequent report by Enticknap and Smither, 1964, ncern #ctgrv. MAY monstr 1 cqmmdVi^X 9 found in the abdomen (peritoneal mesothelioma), as well as in the chest. The exact risk of death of these invariably fatal neoplasms has not been as well defined as has lung cancer, although recording of cases from hospitals near one large asbestos factory has indicated that it must be very common indeed (Borow, Conston, Livornese and Schalet, 1967). Information available from the experience of asbestos insulation workers suggests that approximately five to seven percent of deaths may be due to this neoplasm (Hammond, Selikoff and Churg, 1965; Selikoff, Hammond and Seidman, 1973). More recently, it has been suggested that this estimate is too low, on the basis of the experience of workers in a B n tisn asbestos factory where calculations predictedthat between 10 and 11 percent of deaths would be due to mesothelioma (Kewhouse and Berry, 1975). (c) Gastro-intestinal cancer. Gastro-intestinal cancers (cancer of the stomach, colon and rectum) are also increased in incidence aimong asbestos workers, A number of studies now indicate that the increase is on the order of two or three times the number of expected tumors (Selikoff, Hammond and Seidman, 1973; Elmes and Simpson, 1971). Although this increased risk is relatively limited, especially when compared with lung cancer and mesothelioma, it ,,is nevertheless of considerable importance since a two - or three- I 10 It has been suggested that other tumors are also increased in incidence among asbestos workers, particular, cancers of the larynx (Stell and McGill, 1973; Newhouse and Berry, 1973), and of the esophagus (Selikoff, Hammond, and Seidman, 1973). However, data concerning these neoplasms are less extensive than for lung cancer, mesothelioma and gastro-intestinal cancer and further experiences are awaited. In any case, they are not very common tumors in general and any increase does not weigh heavily on the overall cancer risk of asbestos workers. i Considering all neoplasms, among some groups of asbestos i workers, employed either in asbestos factory work or in the use of asbestos products, as much as 40 to 4Z percent of all deaths have been due to one or another type of cancer, an approximately three-fold or four-fold increase. Of significant importance, new data have recently been made available concerning the cancer risk of workers at the textile mill reviewed for the British standard, including those workers first emloyed after 1933 (Howard, Kinlen, Lewinsohn, Peto and Doll, 1975). It was found that there was excess mortality from lung cancer among those workers who entered scheduled areas after 1 January 1933. There was "clear evidence of some excess of lung cancer and respiratory deaths among those first exposed between 1933 and 1950." FEMAPYRO1D9U94C Equally important was the finding that "there still - 11 - appears to be an excess of deaths due to lung cancer after 15 or more years' exposure" even among those first exposed in 1951 and subsequently. Indeed, it is known that mesothelioma deaths have occurred among the specific group of 290 workers whose experience prior to 1966 had led to the development of the current standard as detailed above (Brody, 1974). C. N O N - O C C U P A T I O N A L , INDIRECT O C C U P A T I O N A L EXPOSURE OR .INTERMITTENT OR BRIEF EXPOSURE Recent data indicate the occurrence of asbestos cancer among individuals exposed to low levels of asbestos, as in environmental circumstances, or to brief or intermittent exposures to higher levels. Analysis of the history of asbestos exposure among individuals in a large series of cases of mesothelioma in Great Britain and South Africa have provided evi dence that brief or intermittent exposure to asbestos may, after the passage of decades, result in mesothelio: (Greenberg and Davies, 1974; Webster, 1973). In such i circumstances, it appears that the lifetime exposure was less than 100 fiber-years/ml. The same discrepancy ! between present projected exposures and the risk of asbestos cancer exists when considering cases of mesothelioma resulting from household contact to asbestos among members of families of asbestos workers (Lillington, 1974) or among residents living in the vicinity of asbestos plants. 12 Of considerable industrial importance, has been the recent description of asbestos disease among shipbuilding and ship repair workers, few of whom actually work with asbestos, but many of whom were, in the past, inadvertently exposed to the asbestos dust resulting from the use of asbestos products by a relatively few of their work mates. In 1968, Harries of the Royal Navy reported cases of mesothelioma among shipyard workers at the Royal Navy dockyard in Devonport, in trades which did not directly involve worker exposure to asbestos, but in which there had been occasional opportunity for exposure merely by virtue of working in the same areas. This original finding has been widely confirmed and numerous cases of mesothelioma have since been reported in former shipyard workers (Whitwell and Rawcliffe, 1970; McEwen et al, 1970; Stumphius, 1971; Greenberg and Davies, 1974).' Studies of populations of current shipyard workers have shown much radiological evidence of asbestos abnormalities among workers in trades only indirectly exposed to asbestos in the yards (Sheers and Templeton, 1968; Fletcher, 1972). Gillam et al (1975), studying the mortality and reviewir the chest x-rays of 439 underground metal miners exposed to an asbestiform mineral, found three times the risk of malignant respiratory disease than ex pected. The fiber concentrations averaged 0.24 fibers/r Further, evidence has indicated that asbestos also acts as a lung carcinogen at levels much below those 13 which will produce asbcstosis. Two surveys of shipyard workers who had x-ray evidence of pleural plaques, but generally not of pulmonary fibrosis, showed a 2.5-fold excess risk of death from lung cancer and high risk of mesothelioma. (Fletcher, 1972; Edge, 1975). In a study of the mortality experience of a large U.S. asbestos products manufacturing facility, it was found that workers in low-dust areas, with a minimum risk of death from asbestosis, had the same high risk of death from various cancers as workers in dustier areas (Nicholson, 1975). Reports of the hazard, or potential for hazard, from exposure to asbestos resulting from use of asbestoscontaining products are very limited. To determine the type and extent of non-occupational exposure, the investigator must generally rely on relatives or persons other than the exposed patient for exposure history. Furthermore, it is extremely difficult, if not im possible, to document brief exposures reported to have occurred 20 or more years before the onset of symptoms. The only known quantitative study of asbestos levels in products regulated by this Commission was reported by Rohl, et al (1975) of asbestos fiber concentrations measured during the use of consumer spackling, patching and taping compounds. This study indicated that airborne fiber concentrations, exceeding / 14 operations and it was reported that "... significant concentrations of asbestos remained suspended and could pervade living quarters for a considerable duration of time..." The authors suggest that the use of spackling and other patching compounds (in mixing sanding and cleanup operations) may expose the user and other members of the household to "... significant concentrations of asbestos". III. CERTAIN CONSIDERATIONS CONCERNING CARCINOCENICITY In the case of asbestos we are dealing with a substance that poses a range of health risks. These include the threat of cancer as well as asbestosis. In considering the issue of carcinogenicity the data cited above should be considered along with leading scientific principles and opinions believed to reflect the research conclusions of international cancer experts. A. LATENT EFFECTS In humans the latency period for chemical carcinogens ay well extend between 20 to 40 or more years. Analogoi periods exist for test animals. This means that the * disease may undergo a long period of development before a tumor is actually detected. Prudence would seem to dictate that every reasonable measure should be taken to eliminate human exposure to chemical compoum as soon PRODUCTION as their carcinogenic nature is identified. / 15 B. INDIVIDUAL VARIATION Cancer development may be influenced by such factors as the differing susceptibility of various body organs. In animal studies it has been found that individual variability in response to carcinogens is great depending upon factors such as age, sex, hormonal status, diet, and genetic factors. Thus, individuals biologically compromised, may be more susceptible than other groups. C. ' "THRESHOLD" LIMIT Because of the variability of individual response to carcinogens and other factors, the concept of a "no effect" or "threshold level" may have little real significance on the basis of existing knowledge, mill* some level, below which exposure to a carcinogen does not cause cancer, may conceivably exist for any one individual, other individuals may have cancer induced by doses so low as to be effectively zero. This is not to say that researchers will never find a threshold level for a carcinogenic substance, but it does mean that the threshold concept for carcinogens is, at present, more a matter of responsible regulatory policy than a precise, scientific determination. . These theoretical concepts have a bearing on the asbesto: issue, particularly as the question of the existence, or nonexistence, of a threshold level of carcinogenic effect. A "no effect" level theoretically may exist, but it has not been demonstrated. Therefore, there is no known threshold level below which exposure to MAY 1994 - 16 The use of asbestos as simulated ash in artificial fireplace logs and in consumer patching compounds poses an unreasonable risk of inhalation of potentially hazardous asbestiform fibers and are exposures which arc avoidable. I 1 I <I inn' ft REFERENCES Anderson, H.A., Selikoff, I.J., Lilis, H., and S. Daum. Conjugal Asbestos Neoplastic Risk. Ann. N.Y. Acad. Sci. (1976). Borow, M., Conston, A., Livornese, L. I., and N. Schalet: Mesothelioma and its Associations with Asbestos: J.A.M.A. 201:587-591, (1967). Brody, J.E.: New York Times, Sept. 30, 1974. Edge, J.A.: Asbestos Related Diseases in Barrow-in-Furnaces. Env. Res. (1975). Elmes, P.C., and M.J.C. Simpson: Insulation Workers in Belfast. 3. Mortality 1940-66. Brit. J. Industr. Med. 28:226-236, (1971). Ehterline, P., de Coufle, P., and V. Henderson: Mortality in Relation to Occupational Exposure in the Asbestos Industry. J. Occup. Med., 14:897-903, (1972). t ' Biticknap, J.B. and W.J. Smither: Peritoneal Tumors in Asbestosis. Br$t. J. Industr. Med. 21: 20-31, (1964). Fletcher, D.E.: A Motality Study of Shipyard Workers with Plural Plaques. Brit. J. Industr. Med. 29:142-145, (1972). Gillam, J.D:, Lemen, R.A., Archer, V.E., Wagner, J.K., and J. Dement: Morbidit and Mortality Among Hard Rock Miners Exposed to an Asbestiform Mineral. Ann. N.Y.Acad. Sci. (1974). Hammond, E.C., Selikoff, I.J. and J. Churg: Neoplasia Among Insulation VJorkers in the United States with SDecial Reference to Intra-Abdaninal Neoplasia. Ann. N. Y. Acad. Sci. 132:519-52*5, (1965). Hammond, E.C., and I.J. Selikoff: Relations of Cigarette Smoking to Risk of Death of Asbestos-Associated Disease Among Insulation Workers in the United States in Biological Effects of Asbestos, pp. 312-317, International Agency for Research on Cancer, Lyon, (1973). Barries, P.G.: Asbestos Hazards In. Naval Dock Yards. Ann. Occup. Hyg. 11:135-145, (1968) Howard, S., Kinlein, L.J., Lewinsohn, H.C., Peto, J., and R. Doll: A Mortal!* Study Among Workers in an English Asbestos Factor. XVIII an Occupational Health, Brighton, England. (1975). A' MAPYRG'1O9U94Cm International 1 Congre: 2 Lewinsohn, H.C.: the Medical Surveillance of Asbestos Workers. Roy. Soc. i:caT J. 92: (2) 69-77, (1972). McFV/en, J., Finlayson, A., Mair, A. and A.A.M. Gibson: Mesothelioma in Scotia Brit. Med. J. 4:575-576, (1970). Newhouse, M.L. and G. Berry: Letter to the Editor: Asbestos and Laryngeal Can Lancet 2:615, (1973). Newhouse, M.L. and G. Berry: The Risk of Developing Mesothelioma Tumors Among Workers in an Asbestos Textile Factory, XVIII International Congress on Occupational Health, Bristol, England, (1975). Nicholson, W.J.: Research Approaches to the Control of Carcinogenic Exposures Asbestos - the TLV Approach, Mount Sinai School of Medicine of the City UnUniversity of New York, New York, 10029. 271:152-169, (1976). Kohl, Selikoff, I.J., and W.J. Nicholson.: Exposure to Asbestos in the use of Consumer Spackling, Patching and Taping Compounds. Science 189:551-553, (1965). Selikoff, I.J., Churg, J. and E.C. Hammond: The Occurence of Asbestosis Amonc Insulation Workers in the United States. NY. Acad. Sci. 132:139-155, (1965). Seilikoff, I.J., Churg, J. and E.C. Hannond: Asbestos Exposure, Smoking and Neoplasia. J.A.M.A. 204:106-112, (1968). Selikoff, I.J., Hammond, E.C., and J. Churg: Carcinogencity of Amosite Asbast Arch. Qiviron. Health 25:183-186, (1972). Selikoff, I.J., Hannond, E.C., and J. Churg: Mortality Experiences of Asbest Workers. Pneinoconiosis, Proc. Iyt. Conf. Johannesburg. 1969, pp. 180-186, Oxford University Press, (1976). Selikoff, I.J., Hannond, E.C.^ and H. Seidman: Cancer Risk of Insulation Workers in the United States Biological Effects of Asbestos, pp. 209-216, International Agency for Research on Cancer, Lyon, (1973). Sheers, 6. and A.R. Templeton: Effects of Asbestos in Dockyard Workers. Bri Med. J. 7:574-579, (1968). Stell, P.M. and T. McGill: Asbestos and Laryngeal Cancer. Lancet 2:416-417 (1973). Stonphius, J: Epidemiology of Mesothelioma on Waliheren Island. Brit. J. Industr. Med., 28:59-66, (1971). WagnerI PROD J.C., Sleggs C.A., and P. Marchand: Diffuse Pleural Mesothelioma an icposure in the North Western Cape Province, Brit. J. Industr. Mod. tit, (I960! inn hgpr^TOS KT.ViT-.TZD BIBLIOGRAPHY 1. Albert R.E. ct nl ihe assessment of Carcinogen ricks in terms of life shortening USA-USSR joint publ; Problem III, Itepic I, co-operative program in Env. Health Pes. 1974 Mathematical projections in terms of temporal effects. Avoids impact of assessing risks in terms of excess cancer deaths rather hardly tolerates anything greater than zero carcinogenicity. ' 2. Albert R.E. & Altshuler, B Considerations relating to the formulation of limits for unavoidable population exposures to environmental carcinogens. Proc 12th ANN Hanford Biology Svrposium May 10-12, 1972 Mathematical projection & discussion of carcinogen exposure risk deciding that "a more meaningful assessment of hazard should include age of occurrence and life shortening effects. 3. Anderson ... Selikoff Asbestos disease resulting from household . exposure to occupational dusts Chest 66:3 (Sept 1974) Found that the dusts brought heme by occupational workers settled in rafters and remained a long time. 4. Anderson, HA Household - Contact asbestos neoplastic risk Annals of the NY Acad Sci 271:311-323 (1976) An ongoing study tracing household contacts living of workers in a factory producing emosite asbestos products between 1941-45 (when the factory closed) 326 household members with no personal occupational exposure to asbestos have thus far been examined. 5. Bader et al (Selikoff) Pulmonary function and radiographic change in 598 workers with varying duration of exposure to . asbestos Mt. Sinai Hosp. J 37:492:500 (1970) Ambulatory asbestos workers screened. Attempt made to relate grading of chest roentgenograms to vital capacity. 6. Berkley, C The detection fc localization of mineral fibers in tissue. Ann of the NY Acad Sci. 132:48-63 (1965) Description of techniques for the detection in-vivo & in vitro 7. Berry G et al Ccrrbined effect of Asbestos exposure & sicking on mortality from lung cancer in factory verkers LANCET 2(775):476-479 (Sept. 2, 1972) Heavy exposure to asbestos in ccrrbination with smoking produce a significant increase in cancer. This was not true of moderate exposures in smokers or non-stokers. 8. Bore?, M. Mesothelioma & its Association with Asbestos JAMA 201(8):93-97 (Aug 21, 1967) Report of 17 cases of mesothelioma within a 3 year period diagnosed at a N.J. hospital within close proximity of a major asbestos producing plant. 9. Borow, M. et al Mesotheliana following exposure to Asbestos with a review of 72 cases Chest 64(5): 641-645 (1973) Critical Rev. Higher risk of occupational exposure because fibers are loose not bound as they are in products for general public. Discusses clinical aspects related to one of Selikoff's cohorts. 10. Bowes, Lancer & Rohl Nature & Range of Mineral Dusts in the Environment In press Trans. Roy Soc. London A broad general background discussion of mineral dusts as pollutants in air, drinking H2O, foodstuffs & drugs. 11. Bruckman, L., et al Asbestos and Mesothelioma incidence in Connecticut J. Air Poll Cent. Assoc. 27 (2):121-126 (1977) Report of 133 diagnosed mesotheliomas to the Conn, tumor Registry between 1935-72 exhibiting a 10-fold increase of this rare cancer. Authors suggest this parallels asbestos increase in the state. 12. Davis, J.M.G. Histogenesis & Fine Structure of Peritoneal Timers ..; J of NCI 52(6):1823-1837 (June 74) Crocodolite was injected i.p. into rats & mice. The resulting timers studied by light & EM microscopy suggested that growths arise iron undifferentiated mesenchymal cells in submesothelial tissues. 13. Davis, JT-SG An electron microscope study of the response of TOsothfffial cells to the intraplural injection of asbestos dust m J Exp Path 55:64-70 (1974) No ncsothelial hyperplasia by chrysotile or crocidolite within 6 ros. in rats, mice or guinea pigs. Fibers in the majority occurred as crystal bundles & averaged 5 inches in length & 0.1 inches in width. Histological changes are described. 14. Englebrecht FM et al Biological effect of asbestos dust on the peritoneal viscera of rats So. Afr. Med. J. 47:1746-1750 (1973) This study used crocodolite & chrysotile. Authors postulate a soluble carcinogen iron the fibers acting upon mesothilial cells to produce anaplastic changes. 15. Enterline, P.E. et al Asbestos dust exposures at various levels i mortality Arch Env. Health 15:181-186 (1967) Workers in the asbestos textile industry shoved increased mortality over 16.5 years iron respiratory & digestive cancer as well as pulmonale & asbestosis. 16. interline P & Henderson V A model for extrapolating to lew levels of asbestos exposure Abstract presented at Conference on Problems of Extrapolating the Results of Lab Animal Data to roes ... Pinehurst, N.C. Mar 11, 1976 Assumptions are made fran other workers data & a mathematical model projected. 17. Evans, J.c. et al Studies an the deposition of inhaled fibrous material Biv. Res. 6:180-201 (1973) Using radioactive tracer methods & nose only exposure in rats it m s found that about 50% of the crocodolite deposited in the lower respiratory tract 17% was cleared in the 1st 30 days. 18. Gibson, J.C. Report of the Advisory Gcrmdttce on Asbestos Cancers to the Directory of IARC Brit J Ini Med 30:180-186 (1973) The UICC working group on asbestos cancers made a scries of reccnmcndations for assessing the hazards of asbestos in terms  . 19. Gibson, J.C. Asbestos Cancer: Past i Future Hazards Pxoc Roy Soc Med 66:395-403 (1973) Presents the hypothesis that fiber diameter of the different types of asbestos cetemine their point of impact in the lung and therefore their chances of causing cancer eg crocidolite mailer than amosite .. carried deeper into lung. 20. Greenberg Metal Mesothelioma Registry 1967-68 Brit J. Indust Med. 31:91-104 (1974) Mesothelioma of the pleura & peutoneixn sure rare but the reported association v/ith asbestos exposure has given rise to the establishment of a register rraintainod by the (new) I-hployment Medical Advisory Service of Britian. 246 confirmad causes. 21. Haley T.J. Asbestosis: A reassessment of the overall problem J.. Pharm Sci 64 (9): 1435-49 (1975) A review of sources of asbestos exposures both occupational and non-occupational & risks of asbestosis and/cr cancer associated with these exposures. The author has cited a report of asbestosis from sawing vail boards without a respirator. 22. Holt P.F. Asbestos fibres in the air of towns Atmospheric Bsv. 7:481-483 (1973) Air sampling cone in a mrrber of cities from Iceland to S. Africa. Asbestos fibers found in minute amounts in all. Suggest a potential risk in the presence of higher concentrations because lung mechanisms cannot handle & coat large number of fibers. 23. Hueoer, W.C. Occupational & non-occupational exposures to asbestos i NY Acad of Sci 132:184-195 (Dec 1975) For an assessnent of the potential scope of an environmental health hazard and occupational & non-occupational implications of asbestos exposure, it is necessary to determine the distribution pattern of the agent from the site of its original occurrence and production (also production figures are included). 24. Huff, J.E. Asbestos: An Overview Env. Chemicals - Honan & Animal Health 3rd Annual Conference Proceedings (1974) A review of the literature on the occupational. & environmental n pr 25. IARC Working Group en the Evaluation of the Carcinogenic Risk of Chemicals to Kan: IATC Monographs on the Evaluation of the Carcinogen. Risk of Chemicals to Man: Asbestos Inti. Agency for Research on Cancer. 1977. A review of asbestos and associated health hazards. This includes experimental studies, sources of exposure and evaluation of the carcinogenic risk to ran. . 26. Kleinfield, M. Biologic Response to kind & amount of asbestos. Joccup Med. 15(3): 296-300 (Mar 73) ` Discusses various factors established theoretical in the production of asbestosis and asbestos related cancers. 27. Kleinfeld, M et al Mortality among talc miners & millers in New York State Arch. Env. Health 14:663-667 (May 1967) Malignancies 4 tires greater in this group of 220 with 15 years exposure than expected. No mesotheliomas. Significant increase occurred 20 yrs later (60-79 yrs) than in asbestos workers (40-59 yrs) 28. Klein!ulu, A al A study of wcrJ:crc ccccd to asbestiferm minerals in penmarcial manufacture Env. Res. 6:132-143 (1973) In a total of 74 workers exposed to talc containing tremolite & anthcphyllite fibers over a mean time of about 6 years, no malignancie are reported. TV different studies 2 exposure levels. ! 29. Lanqer, et al Identification of asbestos in human tissues i J. of Occ. Med 15(3): 287-295 tor 1973) Discusses methodologies used in asbestos identification. 30. lanqer, et al (Selikoff) Inorganic fibers including chrysotile in lungs at autopsy: preliminary report ABA1 Inhaled Part. Vap. 2:683:694 (1970) Chrysotile fibers break down chemically and separate into 30-40 ixn wide fibers in vivo. The anphiboles have not been observed to do this. 31. Lanr.er, Rohl ScliUoff ct nl Inorganic particles in cigarettes nd cigarette smoke (1974) Science 174:585 (1971) Inorganic particles in cigars 4 cigar smoke; Hammond, Langer, ct al. Briefly present some support for hypothesis that the inorpnnic components of tobacco smoke play some role in the etiology of lung fibrosis. 32. Lanner. Selikoff, et al Chrysotile asbestos in the lungs of persons in NYC Arch Env. Health 22:348-361 (Mar 1971) Data from 28 consecutive NYC autopsies:Chrysotile found in 24. 33. Libshitz, H.I. et al Asbestosis of carcinoma of the larynx JAMA 228:1571-72 (1974) '.'Three patients had carcinoma of the larynx, history of asbestos exposures and evidence of intrathoracic changes characteristic of asbestosis. Suggest relation between asbestosis and laryngeal carcinoma. 34. Lebon. J. Mesothelioma & asbestos Exposure Arch Env. Health 14:559-563 (Apr 67) Study of extent of relationship of asbestos exposure to msothelioma diagnosed in S.E. Penn. 35. Lilllngton C.A. et al Conjugal Malignant Mesothelioma Hew Eng. J. Med. 291(11): 583-84 (Sept. 12, 1974) Report of an industrial worker with malignant mesothelioma and that of his wife whose exposure resulted from washing his dirty clothes. 36. .Masson, T.J. Asbestos like fibers in diluted water supply JAMA 228(8): 1019-1020 (1974) Ho carcinoginic effect was noted from patterns of cancer aortallty in a period of 14 years. TE PRGBXJCPTni 37. McCullagh S.F.; The Biological Effects of Asbestos Med. J. Aust. 2:45-49 (1974). In the .urban atmosphere of both the U.S. and England, "The amount of asbestos is between one hundred thousandth and one millionth of that held to be safe in the workplace (according to the authors). 38. HcLachlin, .M-5F et al Radiological diagnosis of crocidoliteinduccd pleural mesothcliomata in the rat. Br. J. of Exp. Path. >55:164-168 (1974). Thirty-six rats received crocidolite intraplcurally. Seven rats developed mesothelioma as diagnosed by X-ray. Three others were misdiagnosed. 39. Miller, Lancer, Feinstein & Selikoff Non-Specific Interstitial Fibrosis. New Eng J. of Med. 292(2): 91-93 (Jan. 9, 1975). Report finding of chrysotile asbestos fibrils by electron microscopy in a patient described as having severe interstitial fibrosis with no known pathogenic dust exposure. Authors suggest EM examination of lung tissue in diagnoses of "idiopathic pulmonary fibrosis". 40. Menkish, D.E.. et al: Exposure to Asbestos During Brake Maintenance. Ann. Occup. Kyg. 10, pp.17-21 (1970). Air samplings were made during blowing-out procedures of brake shoes and drums. Measurements of the dust cloud exceed the fiber standard but personal exposure measurements were below the standard. 41. Maqqiori, Nicholson & Rubin Neighborhood'Contamination with Asbestos. Analysis of settled dust as index of asbestos air pollution in prior Decades. Environ. Sei. Lab. Annual Report (1974).:- 42. Martlachlng, K.J. et al Unsuspected Exposure to Asbestos and Bronchogenic Carcinoma. Brit. Ned. J. 1:746-749 (1977). Asbestos regulations have reduced the risk of exposure to workers in scheduled industries, but asbestos-related diseases will probably be increasingly found among the many workers who nave only incidental exposures to asbestos. MAY 1 43. Murphy R.L.H. ct al. Effects of low concentration of asbestos N. Eng. J. Med 285(23): 1270-1278 Shipyard pipe covcrors, exposed to 5 million particles per cu. ft. for 13 yrs. showed asbestosis 11 times more commonly than the controls and a 382 prevalence after 30 yrs. 44. Murphy R.L. et a l . Floor tile Installation as a source of asbestos exposure Am Rev. Resp. Dis. 100(4) Oct. 1971 Case studies of 2 long time floor tile installers with meso thelioma and pleural complications known to be associated with exposure to asbestos. 45. Newhouse. M.L. et a l . Epidemiology of mesothelioma tumors in the London area ANN of the NY Acad of Scl 132:579-588 (Dec. 65) Elaboration of earlier case study report. Seems to be little doubt of risk of domestic and occupational exposure to asbestos. 46. Newhouse. M.L. et a l . Predictions of mortality from mesothclial tumors in asbestos factory workers. Bri t J . of Ind. Med. 33:147-151 (1976) It was projected that in the London asbestos textile factory cohort studied, 7-112 of the total mortality would be men and slightly more women would die of mesothelioma. 47. Newhouse. M.L.. Asbestos in the workplace and the community ANN Occup Hyg 16:97-107 (1973) S u n a r y of many reports, case studies, exposure rates, asbestos in the environment and notes on non-oecupational exposure. 48. Newhouse. M.L. et a l. Mesothelioma of Pleura and Peritoneum following exposure to asbestos in the London area Brit J. Ind. Med. 22:261-269 (1965) A case study of 83 patients from London Hospital with confirmed mesotheliomas. Of these 9 were relatives of asbestos workers. e' p u b l ] ^ a ] R ^ ^ u l O ) o T Nvj (ipi ^ Nicholson & Rohl. Occupational and community asbestos exposure wallboard finishing compounds (73-74) n! wall t ^ r s J 4 i ^ p ) W b s U ^ a f c W l n N W ' d u J s ! from compounds i.c. fiber counts during mixing and sanding operations \ 50. Nicholson. Rohl & V.'cisman. Asbestos contamination of building air supply systems From Env. Sci Lab, Dept, of Community Med., Mount Sinai School of Med of the City Univ of NY Asbestos found in the air .of those buildings previously fire proofed with asbesti form sprays. Recommendations are made for future monitoring and control. 51. Nicholson. Rohl V'eisnan. Asbestos contamination of the air in public buildings. Final Rpt to EPA, 1975 Same as asbestos contamination of building air supply sustems. 52. Nicholson & Ruhln. Asbestos lung tissue burden following neighbor hood exposure-evaluation of carbon extraction technique To be pub support NCI-CP 43255 A vague outline of the technique is presented. inadequate for the purpose of the study. V*4 A ^ the TCV approach It was considered Annals of the.NY Acad of Sci 271:157-169 (1976) No known threshold for asbestos or other carcinogens, below which no health effect may be manifested. The TLV is risk limitation value. 54. Polednak, A.P. Latency periods in neoplastic diseases J. Epid 100(5):354-6 (Nov 74) Latency period between exposure to a presumed causal agent and detection of (or death from) a neoplasm. Author suggests 2 modcli cumulative exposure; one-insult co-carcinogenic and 55. Pooley. F.D. Asbestos bodies, their formation, composition character I Env. Res 5:363-379 (1972) Formation did not appear to take place or fibers less than 10 u in length and less on crocodolite. 56. Reeves. A.L. et a l . Inhalation Carcinogenesis from various forms of asbestos Res 8 IXgTI rabbi conccntralions scotto! i t r ' n d TrtioSit MAY Only the rats showed lung or pleural carcinogenic response. 57. Richards, R.J. et *1. Ultrastructural changes in lung fibroblast cultures c.%~pnsofl to chrysotile asbestos But J. of E>:p. Path. 55:275-284 (1974) B'l exam sha..,ed chrysotile fibers within sene cells by 4 1/2 hours with nuclear and cytoplasmic changes. 58. Richards, R.J. et al. Collagen and nucopolysaccharide production in graving lur.g fibroblasts exposed to chrysotile asbestos Life Sciences 12(11):441-451 (1973) Cultures exposed to chrysotile and glass fibers for 24 days. Fiber size not stated. Glass caused slight reversible changes. The chrysotile caused increases in collagen and muco polysaccharide levels indicative of fibrogenesis. 59. Rohl, A. Mineralogical analysis of ore from a major US vexmiculite deposit:preliminary investigation Unpublished - Supported by Health Res. Council 4-12-72 Author claims that potentially hazardous concentrations of asbestos may be found but he had not yet quantitated his analysis. 60. Rohl et al. Asbestos in strange places; children's arts and crafts materials, paper products (1973) To be pub. Support NlHiS ES 00928 Asbestos fibers of different types, forms and amounts were found in various paper products. 61. Rohl, Lamer, Selikoff et al. Consumer talcums and powders: mineral and chemical daracterization J of Tax fc Env Health 2:255-284 (1976) TVxenty-cne ocmnercial consumers U.S. Talcs & powders were analyzed between 1971 and 1975. Methods were instrumented and chemical. An appreciable number showed various forms of asbestiform fibers. No mention of product names nor the dates of acquisition. 62. Rohl, Langer, Selikoff & Nicholson. D^osure to asbestos in the use of oonsuner spackling, patching and taping compounds. Science 189:551-553 (Aug. 15, 1975) A number of consumer spackling conpounds purchased in JKC were found to "oontain asbestos minerals as well as other biologically active substances" ("quartz, talc and other minerals with disease potential") m1 4i 63 Seidman, Lilis s Selikoff. Short term asbestos exposure and delayed cancer n s k Abstract fran Mount Sinai School of i-iodicine of City Univ of NY, 5th Ave & 100th St., N, N5f 10029 Occupational exposure to anosite in a cohort followed fran 1941-1945 to 12-31-74. Claim their figures support "fact" that exposure of less than one year duration "results in significant excess risk of lung cancer.'! 64. Selikoff, et al. Asbestosis and neoplasia Am J. Mad 42 (4):487-496 (Apr 67) What this group has written in more detail elsewhere. Presentation of data - 1973. 65. Selikoff, et al. Asbestos exposure smoking and neoplasia ! JAMA 204 *2:106-112 (Apr 8, 1968) Early paper relating incidence of malignancies in smoking or non-smoking insulation workers. 66. Selikoff & Hanrond. Camrunity effects of nonoccupational environmental assestos exposure Am J. Pub. Health 58(9):1658-1666 (Sept. 68) A cautious and scientific evaluation of the many factors involved 1 in properly assessing and assigning cause. 67. Selikoff, et al. Asbestos air pollution Arch of Ehv. Health 25(1):1 (1972) Discussion of the usual i.e. asbestos air pollution level of J disease hazard, epidemiological consideration industry responsi bility. 68. Selikoff. Widening perspectives of occupational lung disease. i Fanr. Med 2:412-437 (1973) A review of past and present work in the various pneunoocnioses and possible relationship to lung cancer. 69. Selikoff. Cancer risk of insulation workers in the U.S. (1974) Insulation Hygiene Progress Reports Vol 6 *3 (Fall 1974) Reprint of a Chapter of IARC volune by Selikoff et al. Primarily a sutmary of what was said before relating to cancer in ABATEM"ATYEO1BUCTP 70. fifflilenffT ihe asbestos exposure of insulation workmen Ins. Kyg Progress rpts Vol 6 "1 (Spring 1975) Discusses post data and concludes there is no significant pro tection to be offered v.orkmcn even if standards are layered to levels less than 5 f/ml. 71. Selikoff, I.J. Lung cancer and mesothelioma during prospective surveillance of 1249 asbestos insulation workers 1963-1974 Annals of the NY Acad of Sci Vol 271:448-456 1976 Prospective surveillance with the likelihood of earlier diagnosis failed to appreciably improve prognosis in the disease. 72. Selikoff, et al. Carcinogenicity of Amosite Asbestos Arch of Env. Health 25:183-186 (1972) Statistical data is presented to support their statement that occupational exposure to amosite asbestos can be associated with serious cancer hazard. 73. Shabad, L.M. et al. Experimental Studies on Asbestos Carcinogenicity J of NCI 52(4):1175-1187 (1974) Carcinogenic activity of different types of asbestos of the USSR Investigated. All chrysotii shewed traces of benzpyrene. 74. Shin M.L. & rirmircer H.I. Acute and chronic effects of interperitoneal induction of 2 types of asbestos in rats ... Amer J. Pathology 70(3) 291-230 (1973) Basically a morphological study of tumor development. 50 mg 2 types of fiber injected with 40% mortality first 8 days and first mesothelioma in chrysotile group at 7 months. 75. Thiess, A.M. Dangers to man arising from toxic substances at the workplace. Xbl.Bart Hyg I Abt Orig B Article in German Toxic dust levels set including asbestos. 76. Thompson, J.G. Asbestos and the urban dweller A m of the NY Acad of Sci 271:196-214 (1976) 500 autopsy cases in both Cape Town, South Africa and Miami, PROBUC Florida showed 301 males and 20t females had evidence of inhaling >hogns fibers. Inhaled fibers may accumulate at lung bases - \ 7 7 . weoman, D.H. et al. Worker sponsored survey for asbestosis. Detection of reupational lung disease sans a control group Arch Env. Health 27:105-109 (1973) Fifty-seven wall board manufacturing workers were examined by questionnaire, pulmonary function tests and limited physical exam, by predictive equations and regression analysis, disease was proved vittout a control group. 79. Wagner, J.C. et al. Mesothelioma in rats after innoculation with asbestos and other materials Br. J. Cancer 28:173-185 (1973) Intrapleural injection of asbestos into rats produced mesotheliomata approx, proportional to the dose and apparently the finer fibers the more carcinogenic. ! \ 1 ABATEMAPYRGBUC GP REG CLRTN VU INFOMASTER 4-04!820M224006 06/12/77 ICS GEOPACB PTL 6 TVX 9108605951 GP REG CLRTN GYPSUM REGIONAL MANAGERS L.H. KABOOS WASH DC REG D. V.* MCCUBBXN - CHICAGO NO REG U.E. TIERNEY - BUCHANAN R.P. BALLAST - GRAND RAPIDS PLT E. C. GALLOWAY - ATLANTA REG W.D. BROOKS - DALLAS REG E.G. REYNOLDS OAKLAND REG I ^PLSNflFPT^ ( i EXHIBIT | GP 127 FROMt GEORGE BAITINGER 6/12 JOINT TREATMENT PRODUCTS CONTAINING ASBESTOS IN BRANCH OR CUSTOMER STOCKS - ASSIST BRANCHES IN SELLING THIS MATERIAL ASAP. 1843 EST GP REG CLRTN E APYRO1D99U'C