Document 05OEq36VLLBE8dwnjZmVEr3b

_ . IJNION cabsids CORPORATION ' 270 PAEK AVENUE . Law Department .' NEW YORK, 3H Y. A0017 ...... ' \ October '$1, 1963 Food and Drug Administration Washington. 25, D.C. _ . ' Re: Asbestos Fiber ' . Gentlemen: (1) This is to Inquire whether you are in agreement v;ith us that.the use of asbestos fiber as an integral component of ' paper and paperboard does not result, and may not reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of the food when the paper or paperboard is employed in contact with food. (2) If not, whether you are in agreement with us that this use of asbestos fiber is generally recognized as safe among ex perts qualified by scientific training and experience to evaluate its safety. (3) If not, we ask you to file this letter as a petition for a regulation under Section ^S-09 of the Federal Food, Drug and Cosmetic Act stating that this use of asbestos fiber is safe. We propose to soli asbestos fiber for this use. Responsible paper manufacturers tell us that it Improves the quality of paper and paperboard for certain food contact use. We base this petition on the generally known physical characteristics of asbestos fiber. While we write in terms of "asbestos fiber" without limitation in view of your presumed interest in a broad regulation^ our company's direct present interest lies in chrysotile asbestos (a magnesium silicate). We attach a table entitled "Solubility and Dissociation Data for.Chrysotile in Water" from The Journal of Physical Chemistr Vol. LX (l$pS) page 1220, and our summary of "Properties of Chryso tile Asbestos.Fiber". We respectfully propose the following regula tion: . `J121.___Asbestos Fiber. Asbestos fiber may be safely used as a component of paper and paperboard intended for use In producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food. ' . ' GTS:R enc. Verv trulv yours. UNION CARBID2 CORPORATION Ey_ George T. Scriba k j 'o 6 u I ' I '?! UCC 003487 un i4d z ~ST.e.l {W-i jv:J.-,?,j. INTERNAL CORRESPONDENCE MlNSftO AND METALS DIVISION To (Nome) Divton Location Copy to Mr. W. C. Thurber UCC Mining and Metals 38th Floor 270 Park Avenue New York, NY 10017 Messrs. R. E. Byrne, Jr. R. F. X. Fusapo J. L. Myers^ File P. 0. BOX 579, NIAGARA FALLS, NEW YORK 14902 Dai* November 15, 1973 originating D*pt. "Calidria" Asbestos Antwtn'dQ letter daft Subi*d Proposed Rulemaking - Asbestos Particles in Food and Drugs - Fed. Reg. Vol. 38, No. 188, Friday, September 28, 1973 Dear Bill: John Myers has asked me to review the proposed rulemaking noted above and let you have my comments. The move by the FDA is a result of further pressure and petitions by environmentalists. Although the FDA has backed off considerably from the total prohibition requested, they are continuing to treat asbestos as an extremely toxic substance. From a strictly legal sense, the regulation does not seem in the main to apply to us. In nry opinion, however, from business and possibly ethical considerations it is highly probable that it will shut us out from any paper or plastisol coating applications that come in contact with food. The use of acidleached asbestos to treat beer may also be in jeopardy in the U.S.A. We know that much of the talc industry and at least J-M are actively fighting this regulation. I don't see where UCC has any real solid place to attack in an original way. Possibly we could l!ma too" some of the arguments already presentee if this would be helpful. I am scheduled to attend a NI0SH seminar on the effects of ingested asbestos in Durham, N.C. on November 18 and 19. The talc industry will be. present and I will try to learn what they plan to do. In the interim, it is suggested that you contact the AIA and see what their plans are. We should then discuss the whole picture on Noventer 21.to settle on a course of action for UCC. Very truly yours, 7c/r^A'w^ H. B. Rhodes H3R:cjb Attachment t ,, . ^ 1 ^J ut UCC 003488 COMMENTS PROPOSED RULEMAKING - ASBESTOS PARTICLES IN FOOD AND DRUGS 121.2006 (b) Good manufacturing practice requires that talc be free from asbestos fibers to the maximum extent practicable. Accordingly, any food or food packaging material containing talc that is not free from asbestos fibers as determined by the method set out in paragraph (c) shall be deemed to be adulterated in violation of section 402(a)(1) of the act. " This paragraph requires that any food or food-packaging material containing talc not free of asbestos is prohibited. Mr. Fusaro has stated previously that this regulation is worded so it applies only to talc con taminated with asbestos not to "pure" asbestos used alone. This is obviously correct in a legal sense but I feel that we woulcLhave a very considerable problem convincing a potential customer that he could hide behind such a thin line. It is also the type of thing that makes newspaper headlines and New York feature articles. If we assume that this regulation will sooner or later be applied to "pure" asbestos, it will have the effect of ruling us out of paper or plastisol coatings for any food packages and out of the use of acid-leached asbestos for beer processing. On this basis we have a very real and direct interest to protect. 133.6 Components This paragraph covers talc in the manufacture and packaging of drugs. It also presents problems but seems to represent too small a market to fight for. 133.8 Production and Control Features The paragraph severely limits the use of asbestos containing filters in the manufacture of parenteral drugs. The market here is small and the arguments harder to come up with compared to the food area. We should probably forget it. H. B. Rhodes 11/15/73 UCC 003489 OOu 3 Dr. K. S. Lane ^ Mr. J. L. Myers-^ Mr. P. J. Morgan e e. , "Ftf&Z The attached correspondence ft seif-explanatory. On initial reading. It Is my opinion that the proposed FDA rule changes are sufficiently remote from our business interests to make comments unnecessary. However, If you have thoughts to the contrary, please advise me so that I may submit the proper response either to the AIA or directly to the FDA. Please advise me by November 1st. "W. C. TKurEer UCC 003490 Asbestos Information Association/North America }0JXE&XXHXSKXX 1660 L Street, N. W. X^MKXHC6XXXyXXlSDQ( Washington, D. C. 20036 October 1, 1973 MEMORANDUM TO MEMBERS SUBJECT: FDA Proposed Rulemaking "Asbestos Particles in Food and Drugs" Attached is the announcement of the Food and Drug Administration notice of proposed rulemaking on "Asbestos Particles in Food and,Drug as appeared in the Federal Register, Vo1. 38, No. 188, Friday, September 28, 1973. The Association proposes to comment on this matter and encourages comments by individual members as well. Deadline of the FDA for receiving comments is December 27, 1973. It is requested that information to assist In the preparation of the Association response be received by November 5. R. H. Mereness Executive Director Attachment UCC 003491 received OCT 3 1973 WM. C. THU33E8 PROPOSED RULES DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Food and Drugjidministration [ 21 CFR Parts 121,128,133 ] ASBESTOS PARTICLES IN FOOD AND DRUGS Notice of Proposed Rulemaking The Commissioner of Food and Drugs has received a petition from the Center for Science in the Public Interest, 1773 Church Street NW,, Washington, D.C, 20036, and the Environmental Defense Fund, 1525 18th Street NW,, Washing ton, D.C. 20036, requesting promulgation of regulations under the Federal Food, Drug, and Cosmetic Act to prohibit the adulteration of food and drugs with as bestos. Petitioners request that the Com missioner publish in the Federal Regis ter "immediately (within 30 days)" the following proposed regulations: 1. Subpart F of Part 121 is amended by adding the following section: g 121.___ Filters eo>i(ain ing asbestos. "Foods that have come Into contact with filters made wholly or partially of asbestos may reasonably be expected to become con'tamlnated with asbestos particles which may b$ Injurious to health when Inqcstcd. Ac cordingly, any food or food additive produced, manufactured, processed or prepared using a filter made wholly or partially of asbestos shall be deemed to be adulterated In violation of section 402(a) of the Act. 3, Part 133 is amended by adding the fol lowing sections: A iGou3 g 133.___ Killrrs ronliiininc asbestos. Drugs passed through (liters made wholly or partially of asbestos may reasonably be expected to become contaminated with asbestos particles which may be Injurious to health when Injected or Ingested. Accord ingly. any druc or drug component produced, manufactured, processed or prepared using a filter made wholly or partially of asbestos shall be deemed to be adulterated In viola tion of section 401(a) of the Act. g 133.___ Talc containing asbestos. Talc Is a naturally occurring hydrous magnesium silicate which may reasonably be expected to be contaminated with asbestos particles. Asbestos particles may be Injurious to health when ingested or Injected. Accord ingly, It Is not considered good manufactur ing practice to add talc, directly or Indirectly, S3 a component In the production, manu facture. processing or preparation of any drug, unless the manufacturer or processor Of the drug first demonstrates by appropriate tests that the talc so used Is free of asbestos particles. Any drug or drug com ponent containing talc which has not1 been demonstrated to be free of asbestos particles hall be deemed to be adulterated In viola tion of section 501(a) of the Act. Petitioners also request that the Com missioner "immediately (within 30 days from the receipt of this petition)" promulgate as a final regulation a zero tolerance for asbestos particles in talc Intended for use as a food additive, pur suant to the proposal published in the Federal Register of August 12, 1972 (37 FR 16407), and take whatever other ac tion the Commissioner deems necessary to eliminate contamination of food and drugs with asbestos. A complete copy of the petition and its attachments may be reviewed at the office of the Hearing Clerk. Food and Drug Ad ministration, Rm. 6-86. 5600 Fishers Lane, Rockville, MD 20852, during work ing hours, Monday through Friday, The Commissioner has carefully re viewed the petition, its attachments, and other available information, and has reached the following conclusions. Each conclusion indicates the source reference upon which the conclusion is based and copies of all referenced material are available from the office of the Hearing Clerk. "Asbestos" is a generic term for a num ber of hydrated silicates that, when crushed or processed, separate into flexi ble fibers made up of fibrils. Although there are many asbestos minerals, only six are of commercial importance. Chrysotile, a tubular serpentine mineral, accounts for 95 percent of the world's production. The others, all amphiboles (crystals with 3 groups of metal ions), are amoslte, crocidolite. anthophyllite. tremolite and acttnollte. These asbestos minerals differ In their metallic ele mental content, range of fiber diameters, flexibility, harshness, tensile strength, surface properties, and other attributes that determine their industrial uses and which may atlect their respirability, dep osition, retention, translocation and biologic reactivity (Ref. 1), Many products such os cement, floor ing, shingles, pipes, fillers, textiles, etc., contain asbestos of one kind or another. FEDERAL REGISTER, VOL 3, NO. US--FRIDAY, SEPTEMBER 2S, ,W3 ' UCC 003492 PROPOSED RULES 27077 Thero (ire profit variations among such products with respect to the chances of fiber release during the use of the prod uct. Tlie likelihood of such liber release depends predominantly on the ease with which the fibers can be dislodged and on the degree to which the use of the prod uct destroys the fibers. Almost all as bestos fiber used In the United States for manufacturing products becomes tightly bound within the products and usually undergoes little actual abrasion or wear beiorc being discarded. Asbestos cement products (accounting for most of the asbestos used in the United States), shingles and floor tiles are in this cate gory. Some asbestos-containing products, such as brake linings, are subjected to great friction; their rate of wear is con siderable, and at times they are almost completely worn away. In the case of brake linings, the application of force is so Intense and the heat created so great that most chrysotile fibers are destroyed by being converted into another sub stance which is non-fibrous. Neverthe less, an appreciable percentage (1 to 3 percent) remains as fibrous asbestos, and fiber release from products such as asbestos, cloth, paper and sprayed fire proofing materials Is a serious source of emission. This usually occurs in densely populated areas. Most of the pipes de livering drinking water are of a mixture of cement and asbestos. Solid wastes produced during manu facture of asbestos-containing products, use of such products, and demolition can be emission sources. These waste ma terials are usually disposed of without regard to their potential as emission sources. Alternate methods of disposal often result in commingling of asbestoscontaining wastes with municipal wastes In open dumps and thus create a long term emission, source. , Asbestos fibers thus are ubiquitous in air, water and a large percentage of the earth's crust. The amount of this ma terial which additionally is added to the environment and to food and drugs by the use of asbestos filters is not known. Therefore it is obvious that the presence oi asbestos in these products is only one email source oLe.xpusnre; ' Asbestos inhalation has been known to be an occupational hazard in workers in asbestos mines. The asbestos is inhaled and lodges in the lungs causing the de velopment of a fibrotic disease known as "asbestosis." Asbcstosis. or abestotic pneumonoconiosis, was the first clearly demonstrated adverse ctfcct of asbestos in man. It is characterized by a pattern of rocntgenographic changes in the lung consistent with diffuse interstitial fi brosis of variable degree and at times with fibrosis and calcification of the pleura;,clinical changes that include line rales, finger clubbing and shortness of breath, each of which may be absent in an individual case: and physiologic changes consistent with a restrictive lung disorder (Refs. 2 through 8). In these workers in asbestos mines, malignancies of tiic lung and of Lire body lining tissues, namely lung cancer and mesothelioma, occur at rates greater than In persons not so occupationally exposed. There is a 5 to 7 fold increase In lung cancer in asbestos workers which is noted as early as 10 to 14 years after onset of exposure and is significant at 20 years (Refs. 0 through 15). Seven per cent of deaths in asbestos workers arc caused by pleural and peritoneal meso thelioma (ltcfs. 1C through 33). Tills is a marked increase since this tumor is ex tremely rare in the general population. There is suggestive evidence concerning an increase m me rate of gastrointesti nal malignancies in asbestos workers (Ref. 34). There is considerable evidence that most human lungs harbor thousands or millions of asbestos fibers although most people do not have asbestosis (Refs. 35 through 37). This is due to the ubiquity of the substance. Some of these fibers are chrysotile asbestos, and amphiboles are probably present also. This number of fibers is relatively small in most persons not occupationally exposed to asbestos compared with the numbers found in the occupationally exposed. The systematic application of quantitative techniques, measuring both coated and uncoated fibers, is needed to define a gradient of accumulated fibers for correction with incidence of disease, on the one hand, and history of environmental exposure, on the other. The methodology for quantification of asbestos fibers of varying sizes is such that the results obtained in one labora tory may vary substantially from those in another. An inter-agency govern mental task force together with other scientists working in this field is cur rently attempting to develop standard technology which can be applied to the identification and qualification of asbes tos fibers. The Environmental Protection Agency is currently investigating four separate techniques in order to establish the best method for identification, quan tification, sizing and typing of asbestos particles and fibers. At present, the Na tional Institute for Occupational Safety and Health (NIOSH) recommends, as a technique for sampling of air, a method based on counting fibers greater than 5 microns in length using phase contrast illumination at 430x magnification with a 4 millimeter objective (Refs. 38 and 39). This technique is currently recom mended for liquid materials until more accurate and sensitive practical methods are developed. However, as indicated be low, another method is proposed for analysis of asbestos fibers in a material sucli as talc. The evidence concerning tile possible hazard from ingestion of asbestos par ticles is contradictory and inconclusive: In an unpublished study by L. M. Swinbum iRef. 40), asbestos particles were fed once a week to SPP Wislar rats for 10 and 18 weeks. The material was adminlstcrcdln butler. Although the par ticles were of the size range known to produce tumors by other modes of ad ministration, no Lumorgcnic etleet was noted. With a single large dose, the fibers were totally cleared by the gastrointes tinal tract In 48 hours and no asbestos was delected In the animal tissues at the end of 1 week. The gastrointestinal tract of the rat seemed to provide an cifecuvc barrier to penetration. In a published study by W. E. Smith, ef al. (Ref .41), hamsters maintained on a diet of 1 percent chrysotile or amosite through life had no gastrointestinal tumors. A report by Westlake, Spjut and Smith (Ref. 42) indicates that the rat colonic mucosa is penetraLed by chryso tile after feeding a diet containing 5 per cent asbestos for 3 months. Cunningham and Pontefract (Ref. 43 and 44) injected chrysotile fibers (9.4 and 94 x 10') directly into stomachs of rats. Fibers were found in blood and other organs, 2-4 days after treatment. Control rats, although having no asbes tos in blood, also had high levels of asbestos in tissues. These workers found that, whereas the tap water in Ottawa (having a filter plant) contained about 2 million fibers per liter, the quality of fibers in soft drinks and alcoholic beverages purchased in the Ottawa area ranged from 1 to 12 million fibers per liter. Even with the technical problems of methodology, this seems to indicate that in some beverages the asbestos content may be about the same as in water, whereas, in others, it may be increased. Thus, it is reasonable to conclude that water and many other beverages for human consumption con tain substantial amounts of asbestos fibers. There is some evidence that asbestos filters may remove some asbestos mate rial. In a preliminary experiment per formed by the Food and Drug Adminis tration. asbestos was added to distilled water and dispersed evenly by the action of an ultrasonic generator. Electron microscopy of this material clearly showed large numbers of asbestos fibers. This material was then filtered through an asbestos filter, and electron micro scopic examination of the filtered mate rial showed a reduction in the number oi asbestos fibers. Nicholson and his colleagues (Ref, 45) Investigated a number of samples of par enteral drugs and found asbestos fibers. Based on their report a study was under taken by the Food and Drug Administra tion concerning contamination of par enteral drugs with asbestos. Although the data are still preliminary, the following observations are pertinent. Parenteral drug samples were collected from a num ber of firms. Based on phase contrast microscopy, 11 of 13 Samples had clearcut evidence of the presence of asbestos, one sample was questionably positive, and one was negative. The number of fibers ranged from 2 to 27 in the positive specimens of variable sample size. Using electron microscopy. 12 of the 12 samples examined were positive. Quantitation is not yet complete. In Miis survey, seven of 13 manufac turers of parenteral drugs do not use as bestos filters; four firms use such filter's fEDERAl REGISTER, VOL. 3. NO. 1 St--FRIDAY, SEPTEMBER 2R, 1973 . A i U 1J u 7 v ' UCC 003493 I 27078 PROPOSED RULES ' foHi>.yc(l by final mi'inbrnnc type filters tone of these uses :u,-,lK-;-,Lfvi filters for Its rin.se water without final Ultra)Ion of such water): ami two firms use asbestos filters only for their rinse water, without final filtration. 1 The preliminary rei'ort of these studies Is on display at the OiTTre of the Hearing Clerk. Any other scientific data in this regard should be submitted to the llear- lui: Clerk. Certain parenteral drugs, such as blood fractionation products, may be filtered several times Uirowfii asbestos filters. Thus far. it is not known with certainty whether the more viscous products could be successfully processed through ter minal membrane filters without com promising safety, identity, strength, . Quality or purity. The precise effect of ' asbestos pad filtration on removal of pyrogens (Ref. 46 and 47) is not com pletely known at the present time. Currently the Pood and Drug Adminis tration is surveying the industry for Information concerning the use of asb estos filters. Results of this survey will be incorporated in the public record. Although the major experimental studies of asbestos have involved Inhala tion of fibers so as to simulate occupa tional exposure, several studies have been performed to investigate the eifect of parenteral inoculation of asbestos fibers. In 1958, Scliniahl (Ref. 48) reported that implantation of asbestos fibers and crumbs in either the subcutaneous tissue or in the peritoneum lead to the develop ment of malignant tumors (sarcomas) in li of 30 rats which survived longer than 15 months after such implantation. Roe and his colleagues (Ref. 49, 60, 51) have performed a number of studies in which asbestos fibers were injected sub cutaneously (Ref. 49) into the flanks of mice. In the first experiments, crocido- lite, amosite and chrysotilc asbestos fi bers were used and each animal was in jected twice subcutaneously in both flanks with 10 milligrams of fibers in saline with an interval of five weeks be tween the injections. Seven of seventy- one mice which survived 40 weeks or more developed injection site tumors. In addition, one mouse developed a meso thelioma of the peritoneum underlying the injection site. The injection site sarcomas were produced by all three types of fibers. In addition. Roe ct al (Ref. 49) showed that the asbestos fibers were widely disseminated from the local Injection sites being deposited rather selectively on the serosal surfaces of the abdominal organs and the retroperi toneal structures as'well as on the peri cardium, diaphragm, pleura and adja cent parts of the lungs and heart. These serosal surfarcs reacted vigorously to the presence of the asbestos fibers mid in 10 of 71 mice, malignant mesotheliomas of the thorax and/or abdomen developed. In a later study (Ref. 51) Kanazawa tt al showed that, after subcutaneous , Injection of asbestos fibers in mice, fibers could be found to have disseminated to regional and distant lymph nodes, spleen. kidneys and occasionally to brain tissue suggesting that some asbestos may enter the circulation. Thus, there is experimental evidence (hat parenteral administration of asbes tos fibers may lead to wide dissemination of such fibers in animals and to the de velopment of local malignant tumors as 8. Soper, W. B., "Pulmonary Asbestosis: A report of a case and a review," Am, Hev. Tubcrc., 22:571-501, 1030. 0. Lynch. K. M., and W. A. Smith, "Pul monary Asfbestosls III: Carcinoma of lung in asbesto-silicosis," Am. J. Cancer, 21:50-04, 1935. . 10. Doll. R.. "Mortality from Lung Cancer in Asbestos Workers," Brit. J, Industr. Med., well as malignant mesotheliomas of the 12:81-80, 1955. pleura and peritoneum similar to those that occur after inhalation of asbestos fibers. The problem of asbestos In the total environment, to which the worldwide scientific community is addressing itself, is very complex. The Environmental Pro 11. Buchanan, W. D., "Asbestosis and Primary Intrathoraclc Neoplasms." Ann. N.Y. Acad. Set., 122:507-518. 1905. 12. Cordova, J. F., H, Tesluk and R. P. Knudtson, "Asbestosis and Carcinomas of the Lung." Cancer, 15:1101-1187, 10G2. 13. Gross, P., R. T. P. dcTrevlUe. E. B. Tokcr, M. Kaschnk and M. A. Babyak, "Experimental tection Agency has published in the Fedk3al Register of April 6, 1973 (38 FR 8820) national emission standards for asbestos milling and manufacturing based on the determination that asbestos is a hazardous air pollutant. This stand ard has been developed despite the fact Asbestosis. The development of lung cancer la rats with pulmonary deposits of chrysotde asbestos dust." Arch. Environ. Health, IS:343-355, 1067. 14. SellkofT, I. J,, J. Churg and E. C. Ham mond, "Asbestos Exposure and Neoplasia," JAMA, 120:23-28, 1984. 15. Borow, M.. A. Conston, L. L. LlvOrnese the SPA also recognizes that a "stand and N. Scholet, "Mesothelioma and Its Asso ardized reference method has not been developed to quantitatively determine the content of asbestos in a material." The present status of this problem is summarized by the report of a committee prepared subsequent to a meeting spon sored by the International Agency for ciation with Asbestos," JAMA, 201:587-591, 1907. 1 1G. Elmes, P. C., W. T. E. McCaughey and O. L. Wade. "Diffuse Mesothelioma of the Pleura and Asbestos," Brit, Med, J., 7:350 353. 1965. . 17. Elmes, P. C. and O. L. Wade, "Relation ship Between Exposure to Asbestos and Research on Cancer iRef. 52). The Food Pleura Malignancy in Belfast," Ann. N.Y, and Drug Administration's review of this Acad, set., 732:549-557, 19G5, report indicates the following areas of further research are necessary: (1) Further epidemiology, particularly with respect to past exposure to asbestos and cancer of sites other than lung, pleura, and peritoneum, ` 18. Enticknap, J. B. and W. N. Smlthcr. "Peritoneal Tumor In Asbestosis," Brit. J. Ind. Med., 21:20-31, 1964. 19. Fowler, P. B. S., J. C. Sloper and E. C. Warner, "Exposure to Asbestos and Meso thelioma ot the Pleura." Brit. Med. J., 2:211 213. 19G4. (a) Assessment of excess cancer risks following exposure to only one type of fiber. (b) Investigation of whether reduc tion of asbestos exposure in lungs below 20. Hammond, E. C,, I. J. Sellkoff and J. Chtirg, "Neoplasia Among Insulation Workers In the United States with Special Reference to Intraabdomlnal Neoplasia," Ann. N.Y, Acad, Sci., 132:519-525. 10GS. 21. Hourlhane. D. O'B., "The Pathology of those causing asbestosis abolishes excess Mesothelioma and an Analysis of Their As risk of carcinoma. sociation with Asbestos Exposure," Thorax, (c) Investigation, of evidence of an in creased risk of cancer resulting from as 19:268-278, 1964. 22. Lichen, J. and H. Plstawka, "Meso thelioma and Asbestos Exposure," Arch. n- bestos in water, beverages, food, or vieon. Health, 14:559-563. 1967, liquids used for the administration of . 23. Mann, R. It., J, L. Grosb and W. II. drugs. O'Donnell. "Mesothelioma Associated with (2) Development of methods of quan titative assessment, size analysis and characterization of particles and fibers. Asbestosis," Cancer, J9:521-526, 1966. 24. McCaughey, W. T. E.. O. L. Wade and P. C. Elmes, "Exposure to Asbestos Dust and Dlffuso Pleural Mesotheliomas," Brit: Med. BzmEscis 1. "Asbestos, the need and feasibility of air pollution controls," Report of the Committee on Biologic Effects of Atmospheric Pollutants, National Academy of Sciences, 1971. 2. Cooke, VI. E.. "Fibrosis of the Lungs due to the Inhalation of Asbestos Dust," Brit, Med. J.. 2:147. 1924. 3. Cooke, W. E.. "Pulmonary Asbestosis," Brlf, Med. J,, 2:1024-1025. 1927. 4. Drctssen, W. C.. J. M. Dallavalle, T. L. Edwards, J, W. Miller, and R. It. Sayers, "A Study of Asbestos in the Asbestos Textile Industry," Public Health. Bull., 241, Washing ton. U.li. Government priming Oilicc, 1938, 12G pp. 5. McDonald. S.. "History ol Pulmonary Asbestosis," ffrif. Med. J., 2:1025-1028, 1927. J,, 2:1397, 1962. 25. McDonald, A. ., A. Harper. O. A. El at tar and J. C. McDonald. "Epidemiology of Primary Malignant Mcsothellal Tumors in Canada," Cancer, 26:914-910, 1970. 26. Newhouse, M. L. and H, Thompson, "Epidemiology of Mcsothellal Tumors In the London Area," N.Y. Acad. Sci., 132:579-588, 1985. 27. Owen, W. Q., "Mcsothellal Tumors and Exposure to Asbestos Dust," Ann. N.Y. Acad, Sci., 132:874-079, 1905. 28. Sellkoff, L. J., J. Churg and E. C. Ham mond. "Relation Between Exposure to As bestos and Mesothelioma," New Eng. J. Med, 272:560-005, 1965. 29. Wright, G. W,, "Asbestos and Hralth in 1DG9," Am. Ecu. Ilcsp. Din., 100:467-479, 1969. C. Mcrcwclhor. E. It. A.. "The Occurrence 30. Sellkoir, L. J.. E, C. Hammond and J. of ruimonnry Fibrosis amt Ollier Pulmonary Churm "Asbestos Ex|iosure. Smoking, and Affections In Asbestos Workers." J. Ind. llyg^ Neoplasia," JAMA. 204:100-112, 19G8. 22:190-223 and J2:"39-257, 1930. 31. Wngner, J. C., C. A. Sleggs and P. M:ir- 7. Mills, U. G., "Pulmonary Asbestosis: Re chand, "Dlffuso Pleural Mesothelioma and port of a case." Aflnn. 3/cd., 13:405-199, 1930. Asbestos Exposure la the North Western Capo * * FEDERAL REGISTER, VOL. 31, NO. HR--FRIDAY, SEPTEMBER 28, 1973 A i uou8 ^ UCC 003494 ^R4'i.1`i.tl.,.l wr n'1 l i,. nfpsk'ncMPia.yyu*..... V. 'MMSM'ecr A'w"T'>e)prr>i,'.'e' ..UMiwmyy 1 )"Wll,"l,'f WUI W.U|Wi a nit PROPOSED RULES 27U7U Province," Brit. J. Ind. Med., 17:200-271, jfrOO. 33.Cliampkm. r.. "Two Cum** of Malig nant Mvsotlicllninu uflcr Exposure to As bestos,*' Am. Hen. Jiesp. I)iiH 103:831-028, 1971. 33. Eclllcofr. I,. J, anil E. C. Hammond, "En vironmental Eplilriukilogy. III. Community Elfeels of Nonoccupallonal KavironmcntaL Asbestos Exposure," rim. J. Puli. Health, 58: 16S8-1CCG, 1903. 34. Wagner, J. C,, "Epidemiology of DliTuse Mcsotljcll.il Tumors: Evidence of an Asso ciation from Studies In South Africa and the United Kingdom," Ann. N.Y. Acad. Sci., 133:575-578, 10G5. 35. Churg, J.. E. C. Hammond, A. M. Langes. W. J. Nicholson, L. J. SelikolT and y. Suzuki. "Biological ElTects of Asbestos." presented at the National Institutes of Health. Feb. 1, 1973. 3G. Anvilvel. L. and W, M. Thurlbcck, "Tlie Incidence of Asbestos Bodies In the Luncs At Random Necrospsies in Montrcnl," Can. Med. Assoc. J., 55:1173-1182. 1966. 37. Causa, D,, R. 3. Totten and P. Gross, "Asbestos Bodies In Human Lungs at Au topsy," JAMA, 182: 371-373, 1965. 38. "Criteria for a Recommended Stand ard--Occupational Exposure to Asbestos," Report of Review Committee, National In stitute for Occuoatlonal Safety and Health, Publication No. IISM 72-10267 (19721, 39. Lynch, J. R. and H. E. Ayer, "Measure ment of Asbestos Exposure," J. Occup. Med., 10: 21--24, 19G8. 40. Swinburne, L. M.. "The ingestion of as bestos by rats (unpublished data)," personal communication to Bureau of Foods. FDA. 41. Smith, W. E,, L. Miller, R. E. Elsasser and D. D, Hubert, "Tests for Carcinogenicity of Asbestos," Ann. N.Y. Acad. Sci., 132:456-468, 1985. 42. Westlake. G. E.. H. J. Spjut and M. N. Smith, "Penetration of Colonic Mucosa by Asbestos Particles. An Electron Microscopic Btudy la Rats Fed Asbestos Dust," Lab. In vest., 14:2029-2033, 19G5. 43. Cunningham. H. M. and R. Pontefract: (a) "Asbestos Fibers in Beverages and Drinking Water," Nature, 232:332-333. 1971. (b) "Symposium on Industrial Chemicals as Food Contaminants.'' Journal of the AO/IC, 56:976- 961. 1973. 44. Pontefract, R. and IT. M. Cunningham: "Penetration of Asbestos through the Diges tive Tract of Rats," Nature, 243:352-353, 1973. 45. Nicholson, W. J., C. J. Mapglare and I. J. SelikolT, "Asbestos Contamination of Parenteral Drugs, Science, 177:171-173, 1972. 48. Tul, C. and A. M. Wright. "The Pene tration of Non-Pyrogen Infusion and Other Intravenous Fluids by Absorptive Filtration," Annals Surj., If 6:412-125,1942. 47. Remington's Pharmaceutical Sciences. "Parenteral Preparations, Pyrogens." Chap ter 82. 14th Ed. (ps. 1524), 1970. 48. Schmahl, D,, "Cancerogene Wirkung Ton Asbest bel Implantation von Ratten," Zeitschri/t fiir KrebsfOTSChung, 62:561-567, 1958. < 49. Harington, J. S. and P. J. C. Roe, "Stud ies of Carcinogenesis of Asbestos Fibers and their Natural Fibers." Annn/s of the N.Y, Academy of Sciences, 132:439--150, 1965. 60. Roe, F. J. C,, R. L. Carter, M, A. Walters and J. S. Harington, '"Die Pathological Ef fects of Subcutaneous Injections of Asbestos Fibers in Mice: Migration of Fibers to Submesothellal Tissues and Induction of Mesothellomatn," Inf. J. of Cancer, 2:628-G38, 1007. 61. Kanazawa, K.. M. S. C. Blrbcck. n. L. Carter and F. J. C. Roe, "Migration of Asbes tos Fibres from Subcutaneous Injection Kites In Mice," British Journal of Cancer, 24:90 108, 1970. 62. "Report of the Advisory Committee on Asbestos Canrers to the Director of the Internntlnnul Arcncy fur Research on Cancer," tint. J. Induitr. Med., 30:160-166, 1973, brane filters. Is also requested. Finally, comment on methods of quantitative assessment, size analysis, and char acterization of particles and fibers, is The Commissioner recognizes that it Is essential in order to develop final not possible to eliminate all sources of methods on which accurate and fair asbestos contact with food and drugs. compliance can be based. Asbestos is used In virtually all pipes Therefore, pursuant to provisions of carrying' drinking water, in buildings in the Federal Food, Drug, and Cosmetic which food and drugs are manufactured, Act (secs. 402, 502, 701, 52 Stat. 1046 and in many filtering systems used in the 1047, as amended, 1050-1051, as amended, manufacture of food and drugs, and is 1055-1056, as amended; 21 U.S.C, 342. found ih some substances, notably water 352, 371) and under authority delegated and talc, used in the manufacture and to him (21 CFTt 2.120), the Commissioner processing of'food and drugs. Neverthe of Food and Dings proposes to amend less, the Commissioner also recognizes Title 21 of the Code of Federal Regula that asbestos fibers perform no functional tions as follows: purpose in talc and arc an unnecessary I. In Fart 121 by amending 5 121.101 contaminant. It is therefore reasonable to require precaulions to be taken in the manufacure of food and drugs, as part of good manufacturing practices, to assure that the amount of asbestos fibers in any food or drug is reduced to the minimum feasible level. Accordingly, the Commis sioner has concluded to take the follow (d)(8) by alphabetically adding to the table a new item and in paragraphs (h> and <l) by revising the entry for "talc", to read as follows: 121,101 Substances that are generally recognized us safe. * ing action: (d) 1. In view of the demonstrated hazard in animals from injection of asbestos fibers, the Commissioner is proposing that product ToiartfiCt Limitations of restrictions the good manufacturing practice (GMP) regulations for drugs be amended to re 4 m quire that filtration procedures for pa rental drugs shall utilize either a non- ift) .Miscellaneous and.'or general purpose food asbcstos-containing or non-fiber-releas additives. ing filter such as a membrane filter or, if m * an asbestos-containing filter is neces Talc (free ofasbestos In chewing pm sary, shall also utilize an additional non asbestos-containing or non-fiber-releas- fibers os deter* mined in J Kl.SlXtt). base end as an unsticking agent In forms us-od in ir.g filter such as a membrane filter to reduce asbestos fiber content to the min imum level feasible unless such a subse * molding'food shapes. quent filter will compromise the safety, identity, strength, quality or purity of (h) * the product. ' 2. The Commissioner Intends to pro mulgate a final regulation for talc under 5 121.2006 as soon as a method for deter mining asbestos fibers in food-grade talc Tale (free of asbestos fibers as determined In 1 121.2008). * {!>* is validated. Such a method is proposed Talc (free of asbestos fibers os determined below, as part of a republication of the In S 121--008). earlier proposal in which no methodology * , was specified. The Commissioner con 2, In Part 121 by amending Subpart E cludes that a final regulation for talc by adding the following new section: under Part 121 cannot be promulgated until a reproducible and accurate method 121.2006 Talc. can be specified for compliance purposes. (a) Talc Is a naturally occurring 3. The Commissioner is also proposing hydrous magnesium silicate subject to that any talc used in the manufacture or a prior sanction for use in coating pol processing of drugs meet the specifica ished rice. It is found in natural deposits tions for this substance that will be im that may be contaminated with asbestos posed by $ 121.2C06. fibers. - -------------- - 4. The Commissioner realizes that the (b) Good manufacturing practice re Issues raised in this notice arc complex , and have widespread ramifications. Com-/ nient is requested on all aspects of the public health significance of ingcstiqii quires that talc be free from asbestos fibers to the maximum extent prac ticable. Accordingly, any food or food and injection of asbestos fibers. Sinte packaging material containing talc that adoption of any new filtration require is'llOt lrec irom asbestos fibers as deter ments may require use of additional mined by the method set out In para equipment, comment on the availability of appropriate equipment, the need for use of asbestos-containing filters us con graph (c) shall be deemed to be adul terated In violation of section 402(a) (1) trasted with filters which contain no^ of the act. ____ __________ asbestos, and the lime needed to ob-~~ -- (c) The following method shall be tain and begin using non-asbest os- used to determine compliance with this containing final filters such as mem section: - No. JB8--Ft. I- fEDERAL REGISTER, VOL. 36, NO. Ul-- FRIDAY, SEPTEMBER 2R, 1973 A ' O J VJ J UCC 003495 V 'i tMl miuj* .Nifii I'jk 'jPlPiiii MM.'PJH*' *rr 27080 ' PROPOSED RULES (1) Tlic various kinds ot asbestos are distinguished from talc and from each other by their refractive indices, other optical crystallographic properties, and morphology as determined with a polar izing microscope (Methods of the Asso ciation of Official Analytical Chemists, 11th Ed., 1970. Sections 3G.541-3G.S-n, p. 717-721).1 Talc occurs mainly In the form of thin plates, which may appear fibrous when seen edgewise in micro scopic view. Beta and gamma indices of talc vary from about 1.575 to 1.500, beta being very close to gamma. All of the principal refractive indices of chry sotile are less than 1.500. Chrysotile asbestos Is therefore distinguishable from fibrous looking talc particles in a ,1.574 refractive index liquid and the other five amphibole types of fibrous asbestos from talc in a 1.500 refractive Index liquid. The table of optical crystal lographic properties for talc and the asbestos minerals in subparagraph (3) shows refractive indices which are usually encountered in these minerals, but occasional samples may have indices which are somewhat higher or lower. For practical measurement of optical prop erties shown in the table, particles iden tified by this method should be at least 5 or longer. (2) Weigh out 1 milligram of a repre sentative portion of talc on each of two microscope slides. Mix the talc with a needle to spread evenly over the suitable area on one slide with a drop of 1,574 Tefractlve index liquid, and then the other with 1.590 liquid, and place on each a square or rectangular cover glass suffi ciently large so that the liquid will not run out from the edge (ca. 18 mm. square) and will provide a uniform par ticle distribution. Fibers counted by this method should meet the following cri teria: (i) Length to width ratio of 3 or greater <il) length of 5 jim or greater (ill) width of 5 am or less. Count and record the number of asbestos fibers found In each 1 milligram as determined from a scan of both slides with a polariz ing microscope at a magnification of ap proximately 400 X. In the 1.574 refrac tive index liquid, chrysotile fibers with Indices less than 1.5-74 in both extinction positions may be present: in the 1.590 refractive index liquid, the other five amphibole types of asbestos fibers with Indices exceeding 1.590 in both extinc tion positions may be present. Check the extinction and sign of elongation for tentative identification. For specific identification of asbestos fibers, make ad ditional mounts in appropriate refractive Index liquids, and refer to the optical crystallographic data in the table. A count of not more than 1000 amphibole types of asbestos libers and not mure than 100 chrysotile asbestos fibers per milligram-slide constitutes the maximum 'Copies may bo obtained from: Association of Ofllclnl Analytical Chemists P.O. Box 5-10, Benjamin Franklin Station Washington, DC 20014 limit for the presence of these asbestos fibers in talc. These limits aasure a purity of talc at least 99.9 percent free of amphibole types of asbestos libers and at least 99.99 percent free of chrysotile asbestos fibers. (3) Optical crystallographic charac teristics of asbestos minerals and talc: Kxaun.i:s or HriAcrivx Indickj <nI Substance F.itlnrtloa Elongation AcllnoUte......._______ ___________ I. Il( 1.61S-1.&M 1.630 1.626-1.60S 1M-116M41 Inclined............. . Positive. Ainosili...!.............U<.-0W7* .. 1.6*0 1.702 A nlhopliyliite...... ......... .......... . 1.6(4 l.fr.18 . L 623 . parUlol.................................. PositiTe. ...... iris* 1,606-1.674 1606-1666 1.615-1.017 , 1.606 . 1.619 IfidO* 1631 . 1.610 1.619-1.03 1630-1612 1640-1.657 . 1.629 1.633 11.663334 1640 1.632 Clirysotil*........................ .................... 1.493 1.601 1604 1612 1517 Parallel.,Positive. 1.622 1.639-1.669 1630-1364 1,537-1,607 1.61-1.64 ; 1.54-1.65 1.643 . 1355 1.642 1643 (calc.) 1636 1.646 1630 1.637 ' 1.646 1637 1557 Croeldollte. 1.648 1.693 1660 1695 1695 1660 Parallel. 1607 N'egatir*. 1.697 1700 1703 ................................... Talc............ .. L 636-1.643 , 1676-1590 Parallel or 2* or 3*. Positive. 1.639 ............1*689* 16S9........................................... 1.639 1669 1.669 ........................................... 1.639 1.639 1689........................................... 1.640 nearly-o 1573 ........................................... 1.641 1.6S3 1663........................................... 1.692 1692 ........................................... 1.M3 1.694 1634 1694 ........................................... 1684 . ..... ............. TremoUte. . 1599 1.613 1G2S inclined........... Positive, 1.699 . 1613 1623 ........................................... 1699-1612 1613-1.6W 1.623-1637 ........................................... 1.600 1.616 1627 ........................................... 1.602 1614 1.C35........................................... 1*602 1.618 1631........................................... 1602-1623 1613-1634 1624-1660........................................... 1.604 1612 1628........................................... 1.604 1617 1.630 ........................................... 1.609 1.622 1636 ........................................... 1609 1623 1636 ........................................... 1*613 1.621 1634 ........................................... n+n. 3. In Part 133 by adding the following new paragraph (1) to 5133.G to read as follows: 133.6 Components. * * ' * * <i) Talc is a naturally occurring hy drous magnesium silicate which may reasonably be expected to contain as bestos fibers whicli may be injurious to health. Current methodology cannot as sure the absence of asbestos in talc. Accordingly, any drug, drug ingredient, or drug nackaninc maternJTcontaming talc that tails to meet the specifications of paragraph (c) of 5 121.2006 of this chapter as determined by the method set out in that paragraph shall be deemed to be adulterated in violation of section 501(a) of the Act. 4. By adding the following new para graph (j) to 5 133.8 to read as follows: 133.8 Production and control procc* dti rrs. * (j) Use of asbestos-containing filters: Filters used In tire manufacture of a parenteral drug or parenteral drug in gredient shall not release fibers into such products. No asbestos-containing or fl ber-releaslng filter may be used in the manufacture of a parenteral drug or par enteral drug ingredient unless it is not possible to manufacture that drug or drug ingredient without the use of such a filter. If use of such a filter is required, an additional non-asbestos-contamiug or non-fiber-releasing filter such as a membrane filter shall subsequently be used to reduce the content of any asbes tos-form particles in the drug or drug in gredient. Evidence for reduction snail be based on the use of the methods de scribed. in "Criteria for a Recom mended Standard--Occupational Expo sure to Asbestos," Report of Review Com mittee, National Institute for Occupa tional Safety and Health. Publication No. HSM 72-102G7 (1972).1 Use of an asbes tos-containing filter without subsequent use of an additional non-asbcstos-con- tainlng membrane filter is permissible only upon submission of proof to the Food and Drug Administration that us? of a non-asbestos-containing membrane * Copies may be obtained from: Superintendent of Documents U.3. Government Printing OJtice Washington, DC 20402 FEDERAL REGISTER, VOL. 38, NO* 188--FRIDAY, SEPTEMBER 28, 1973 I O UCC 003496 filter trill, or is likely to, compromise the safety or effectiveness of the drug. Interested persons may.'on or before December 27, 1973, file with the Hearing Clerk. Food and Drug Administration, Rm. 6-86, 5600 Fishers Lane, Rockville, MO 20352, written comments (prefer ably In quintuplicatc) regarding the pe tition and the Commissioner's proposal. Comments may bo accompanied by a memorandum or brief in support thereof. The petition, background information re ferred to in this proposal, and comments received may be seen in the above office during working hours, Monday through Friday. Dated September 24, 1973. A. M. Schmidt. Commissioner of Food and Drugs. ' JFR Doc.73-20711 Filed 3-27-73,8:45 am) Social and Rehabilitation Service [45CFR Part 221 ] FAMILIES, CHILDREN. AGED. BLIND, OR DISABLED INDIVIDUALS Service Programs; Correction FR Doc. 73-19242. published at page 24872 in the issue dated Monday, Sep tember 10,1973, is corrected by changing: 1. The number "233" in item number two of the preamble, fifth line, to *23314"; 2. The code designation "221.6(a) (3) (i)*' in item number two of the preamble, seventh line, to "221.G(c) <3) (i) 3. The code designation "211.6(a)(3) (Hi)" in item number throe of the pre.amble, fourth line, to "221.6(c) (3> (iii) 4. The code designation ''211.C(a) (3) (vii) " in item number four of the pream ble, fourth line. to "221,G(c) (3) (vii)"; 5. Ihe code designation "211.7(b)" in item number five of the preamble, fourth Jine, to "221.7(b)"; 6. The code designation "211.9(b) (3)" in Item number seven of the preamble, sixth line, to "221.9(b) (3)": 7. The code designation "221.6(a) (3)'' Jn the words of issuance, number three, first line; and in 5 221.6(a) (3) itself, first .line, to "221.6(c) (3)"; 8 The number `'8" in 5 221.6(a)(4), (now corrected to 221.6(c) (4) >, fourth line, to "6": and 9. The word "secured" in 5 221.9(b) <5), fourth line, to "secure". Approved September 24,1973. Thomas S. McFee. Deputy Assistant Secretary for ` . Management Planning and Technology. IFit DOC.73-J0738 Filed 9-27-73; 6 ;4S m} A O "j -T If O ij / | UCC 003497 September DJ3* 1967 Dr, V. J. OOl union Carbide Belgjiao IT.V. E57^v3uaTT5aarM -- Brussels 5, BSUBtBI Subject: Asbestos Tiber togortors Caaaltteo Dear Tom . Please refer to your letter of September 13 to Mr. Dexter. Tour feeling of continuing to cooperate with the Asbestos Fiber Baparbers Committee aecns to bo About the wisest course to follow ehort* as you say* of incurring cay obligations la cny ether area of oar asbestos activities* As Freak Hester palate out, it is entirely possible tto same problem will axles elsewhere so that vtwrt wu laaro hero sy continue to bo useful In more ways than one. On renewing the history end correspondence, the Impression ie gained that wo have gene quite a ways toward meeting the objections to handling asbestos* sod X wonder whether our wort with pellets* paper rather than cloth bags* cardboard bosas* etc* doesn't stand us la good steed. XU brief ws suggest you cooperato with tbs Caaaittee sod keep us informed of developments. Very truly yours* T.F.Fraegos/jvp ccs Mr. F.D. Etsxtor - I7TQ cc; Ur, JJ* Setter - HTO cs* Mr* M.P. Ballmer - STD cct Hr, X.C, Sayers * London Associate Product Marketing Manager UCC 003498 CHEMICALS AND PLASTICS fo(Norni Civilian '.ocatjoft Mr. T. F. Frangos 2^th Floor Zopy to ' 270 PARK AVENUE, NEW YORK, NEW YORK 10017 d'* September 20, 1967 O^t'Cinafino DftpL ' Antwriny Ivltgr daU Sirbftef Relative to the letters Tom Hall wrote to me dated 5 September and 13 September, I suggest we answer as follows: a. The matter of price in the 5 September letter was already answered by you although you may wish to expand upon it. b. We appreciate the efforts to establish a '68 plan and await the details with interest. c. We recognize the problems of selling Asbestos T in Europe and are looking at the possibility of making "T" in Europe. We have nothing specific on this yet and any plans will be thoroughly checked with theEuropean people before they are firmed up. d. In reference to the work with the Importers Committee, I would recommend that we continue to maintain an active contact with this group and work with them. Naturally, we will wish to avoid obligations on our part insofar as possible and also if we can capitalize on the fact that we ship pellets we should do so. Under any conditions, close communications with what's going on here I regard as highly desirable since there is at least a possibility that this same type of situation will spring up elsewhere. FDD/lr A sJ 7 UCC 003499 UNION CARBIDE BELGIUM N.V. RECEIVED SEP 19 53b/ T.P. FRANGOS V/REF. N/RSF. 1415 TJH/MLF bruxelles s, 13 September, 1967 Mr. F.D. Dexter 45th floor Union Carbide Corporation 270 Park Avenue New York 10017 Dear Frank: 1 am enclosing with this a <|opy of a report made by Ian Sayers, our asbestos representativein the U. K., concerning a recent meeting he attended of the Asbestos Fiber Importers Committee. The details of the meeting are given in the report. - I believe it is evident from the report that all asbestos producers are facing a very serious problem in the U. K. in getting their material handled on the docks. It appears that the situation is not going to get any better as the popular publications continue their series of exposes about the dangers of asbestos. My purpose in writing to you is to ask for your comments concerning the advisability of our continuing to work with this industrial committee. 1 am sure you are aware that we have always avoided any close connections with the conventional asbestos producers so that we could maintain a free hand in all of our production and marketing decisions. In this case, however, it appears that we may have something to gain in joining in a common fight against an emotional problem. I feel that we should continue to cooperate with this group as long as we can do so without incurring any obligations in any other area of our asbestos activities. Here I guess you will have to rely on us to keep out of any unwanted entangle ments. I do not intend that either Ion or I proceed further until we have some comments back from you on this subject. If y-ou are neutral then we will proceed to cooperate at "arms length". I will keep you fully advised. What.do you think? Best regards. T. F. Frangosy A ; uOU 1. C. N. J. Sayers Setter SCHgLURlAAN - ANTWERPEN DMAS J. HALL. AVENUE kOUISE N9 - BRUXELLES B TL. (03) 41.ap.20 ' TELEX 31671 TELEGA. UN (CARBIDE * ANTWERPEN HANtOELSREGl$TER TEL. (Oil 38.SO.60 - TELEX 23'0O TtLftfH. UNICARBIDE - BRUXELLES ANTWfiHPEN I 49.2-' UCC 003500 &GPO&T / gc' ^attatos: t#%f er"'G"'s*' '*>#>****. AJeaj DotM f MCT-a&y *J& UJ,rU &* r ^ aA"OAJ*S TO K//T7/T- AA O* gS*7*r>OAJ S To AC <W VS/A/CSACS. >oc*sgs /n/*y ujptjt itPusns a# OoajtA ia/sP-s. ^Ot/^sVJ^6 S*eaU e<*o yv ^/=> &or fiocjegss- Qa/ov&t l$CeoC CHB.\r.se,,e~r. tte ^>So M9S ' /9/0S'7* Og cetoe^o^ aa/aq >Ati/s s cem ., . 70 ,K/k: *J/ /XutJFTS S&rrtSA/c- S>v&s/Cr SPHif>sr>J?Arr Th/jE fRoKi-esyi *r- Go /ttuAy. &y*-/es boCStrSS /Ay T&a/o y~0 STOP An. PSJS^SToS SM/P/n^flJ'XS. A >..' 0 J -1 UCC 003501 C MB 1 *> f .<<; 'XW t INTERNAL CORRESPONDENCE UNION CARBIDE CORPORATION fo (Nae>J DMtiori ImoIIm Mr. J. L. Myers Mining & Metals Division P. 0. Box 579 Niagara Falls, New York Pol* OWsfaeffofl D*pt Aniwring Ufttr daft ec ; CrT C ^ Si' 7% fV 270 PARK A^i^NEW^O^ NEWARK 10017 ^'' May 14, 1971 Medical Department. Oi'-a. /f? /; o' Copy to Mr. R. E. Byrne Dr. G. U. Dernehl Mr. J. W. Rawlings Dr. H. B. Rhodes Dear John: StrbfKt Toxicology ^C I vi^D Lice: - CALJOFirA ' :Tr ca. For some time it has been rumored, if not officially stated, that asbestos would be on the first list of hazardous materials to be named by EPA. Actually the few materials named so far are only the beginning of the list. I believe there will be added lead, arsenic, selenium, chromates, manganese, some nickel compounds, chlorine, sulfur dioxide, phosphine, arsine, nitrogen dioxide and various organic compounds along with other materials that I have overlooked. As a matter of fact, if toxic response to small quantities is the criteria, then the list will be long indeed. Therefore, you can reasonably argue, I believe, that the need for control of exposure to asbestos is not greatly different from a similar need in relation to many materials that are common in our daily lives. We believe that adequate control is practically possible. Asbestos, of course, is a toxic material that must be carefully controlled to prevent over-exposure of people who handle it or live near areas where it is handled. This we must accept. However, we argue that it is a material of great merit in many applications and that the control required is not greatly different from that we would provide for many other materials. This will be particularly noted as the nation feels the full impact of the new Occupational Safety and Health Act that became effective April 29, 1971. I see nothing to be gained by questioning EPA on the toxicity of asbestos at this time. There has been too much publicity on it recently for their stand to be modified without strong evidence to the contrary. Actually, if we can get them and other official agencies to accept a belief that control in use and application is reasonably possible, we shall have accomplished a great deal. Very truly yours, PWM: dp Paul W. McDaniel Industrial Hygiene Engineer ' 0 a / ' UCC 003502