Document EdpvExbZnakY9pgR6dJwDRnNj

Air Products and Chemicals, Inc. Box 538 A^erMOwn PA '3 105 Teiecrc^e 12 ' 5) 431 -4911 ii ) W 'M_ ^ //A-t u>,'~ < lCT RECEIVED MAR 1 10Q; PRODUCTS DR. R. T. GO i TESiVIAN 7 March 1985 Dr. H. C. Shah Chemical Manufacturers Assoc ation 2501 M Street, N.W. Washington, D.C. 20037 Dear Dr. Shah: I am sending you a copy of a recent article on epidemiology studies among VC-exposed worl< ers that you may not have seen, This could be of interest in connection with the EHA study. Very trul John/jyBarr, Manager Regulatory Response JTB:csb cc: R. Gottesman The Vinyl Institute Attachments: Letter to the Ed itor. Cancer Facts and Figures, 6 Feb. .1985 Article entitled "Industrial Hazards of Plastics and Synthetic Ela$ tomers". SPI-00441 Air Products and Chemicals. Inc. Box 538 Allentown. PA 18105 Telepnone (215) 481-4911 __ AIR PRODUCTS " 6 February 1985 Editor, Cancer Facts and Fi ciures American Cancer Society 90 Park Avenue New York, NY 10016 Dear Sir or Madam: The past several editi 01 s of "Cancer Facts and Figures" have contained a statement that yp u are conducting follow-up work on vinyl chloride-exposed worke rs. As a user of vinyl chloride we attempt to keep aware of the results of such studies, but we have not seen results from your p ogram. Can you share with us yiur protocol, and any preliminary results you may have obtained? We wish to provide our employees with as much information on jhis subject as possible, and would appreciate your assistance. JTB:csb SP1-00442 INDUSTRIAL. HAZARDS OF PLASTICS AND SYNTHETIC ELASTOMERS Proceedings of the Intemational Symposium on Occupational Hazards Related to Plastics and Synthetic Elastomers, Espoo, Finland, 'Jovember 22-27, 1982 ditors JORM JARVISALO PIRK O PFAFFLI HA Rl VAINIO Institute of ccupational Health Helsinki, Finland ALAN R. LISI3, INC. NEW YORK Contents Contributors . Prelace Jorma Jarvisalo CHAPTER!. S> oc Synthetic Polyrr Jukka M. Martinr Polymer Proces: Vaino Era .... Additives in Syn Lawrence Fishbe Carcinogenesis ? Evaluation at the J. E. Hutt and J.A. Trends in Cancer Industry William J. Nicholsc Reproductive Har K. Hemminki, M.-L CHAPTER II. POl Production and Prt Ariel Hof!........... The Toxicology ol I Bo Holm berg . . . Toxicity ot the Com Additives Lawrence Fishbein . Phthalate Esters Ca J.E. Huh and W.M. K Occupational Haxarc William J. Nicholson. Preventive Measurer Production Industry S. Tarkowski .... SPl-00444 1 OCCUPATIONAL HAZARDS IN THE VC-PVC INDUSTRY William J. Nicholson, Paul K. Henneberger and - - Herbert Seiddan. 't.Environmental Sciences Laboratory, Mount Sinai School of Mepicine of CUNT, New York, New York 10029 (WJN, pH) and American Cancer Society, 4 ' W. 35th Strejet, New York, New York 10001 (HS). INTRODUCTION =r0n January 24, 1974,-The Wall Street Journal publish ed an article describi ng the occurrence of three deaths from hiemangiosarcoma of the liver among polyvinyl chloride (PVC).;producti6n".'worke:rs~at the B.F. Goodrich Tire and Rubber Company plant in Louisville, Kentucky. This announ- . cements, shattered^ the relatively complacent view toward health .effects associ ited with plastic production .in general and PVC production" iii particular. At the time, U.S., and Western European production of' vinyl chloride (VC)_'j-s-x--c--e--e-rded 6 x 10 m"ni itric tons.' Numerous mortality and clinical studies were undertaken in the major producing countries in ~an attend t to establish the extent of the carcinogenic risk and to identify clinical parameters useful for surveillance of exposed groups. Because of the immediate concern in 19 "'4, most of these studies were com pleted between 1974 and 1977. Several reviews and sympo sia "on human health effects from VC exposure have been published recently, superb one is by Lelbach and Mar- steller (1981). : p.r -- - The exposures wer high that led to the disease observed' in these varioiis studies. Typical concentrations in the industry were es iraated to be about 1,000 ppm prior to 1955, from 300-500 enuring 1955-1970, and from 100-200 during 1970-1974 (Barnes 1976). However, variations from such exposures would have occurred in specific plants (Rowe, 1975). While historical average exposures were generally less than 1, COO ppm, peak exposures often ex- SPI-00445 (years) exposure (years) follow -up (years) l ta to cS t u d y C o u n t r y ohort a d d itio n a l o f d e a th s !, o f exposure latency possible fo llo w -u p year of A n a ly s is Percent ' . Number ' i.' Percent ' Minimum ' Minimum E a r lie s t Maximum Last r-s \r\ <0 W ^r*m r** r* m <n O' O' PO** O' i/I -O' o>r** p- O p** n r- p* r*. O' O' O' rr-Md Neo <1n/1 Mnl Ml < PM 35 cx ;-'.i Longer la te n c ie s considered fo r some causes o f death analyzed sizeuntraced P** o r> r** O' Ml *T ra. P*m V"1 -h o O Ml N O m CO fs. 'O -o n <N m m o <N O' P-. sO zJ Q < < CfJ < Cu < < 05 < zH in (A < to to UJ 3 to aM Z LA 5 Z 5 n Z oZ H 3 3 u wd 9) 4J 3 V 4J N U 41 NV 3C 4J O' O' 9) O u r rx. u r* 41 O' 3 O' >s O' CO -* GO 03 uW aH o 3 8 > H c a** am -o e i_t w p h O' 0 rs. 4) 8 CO 01 8 O' 3 Cl a4 u P*. O' -O -a aw C u aH u Q 3 AM aW 8 ra 01 3 a V Q c 3 H u 3 -o u 3 a o 0 V <--* d u 8 X Ml --* M \0 3 O' j3 vr wi e O' u 3 3 r " m X r*. 3 CJ u p. 3X 3 O' cr c O' 3 O' -- O' u O' O' 8 2 UJ u. -1 = - Z - O 05- H < 3 SPI-00446 5 diluted by the inclu:: ion of 'many individuals with very short and recent period s of exposure. Turning to chronic liver disease, one remarkable finding is the absence of significantly elevated mortality from this cause in most of the populations under observa tion. The only study with a significant elevation is that of Masuda (1979) in which five deaths from chronic liver disease occurred where only one was expected. However, this must be consider id in the light of an equally high mortality from liver d sease (6 observed vs. 1.4 expected) in a comparison popula tion followed for control purposes. Five of 62 deaths from chronic liver disease seen in the study by Bertazzi et al (1979) are unusual, but the limitations of this study and lack of details make evaluation difficult. The genera Lly benign results in other studies contrast sharply with the severe liver disease from VC exposure documented in clinical studies (Marsteller et al, 1975). Hepatomegaly, hepatic fibrosis, portal hypertension, and bleeding esophageal varices have commonly been found in individuals heavily exposed to VC, even .without concomitant exposure to alcohol. rff;Table 3 lists the mortality data for primary cancer-, of ' the liver and bili iry passages and for cancer of the lung, trachea and bron:hus. In the case .of liver cancer, the overall data are consistent and dramatic. Hemangiosarcomas of the liver were found in eight of the twelve Tstudies. In each of the-eight, a very large and highly significant SMR for liver cancer was seen. Methodological limitations can accourt for negative data in the other four studies. The lrrge SMR's observed, however, are largely the result of low values for the expected number of cases rather than a high incidence of observed cases, Only 2? separate liver iemangiosarcomas were identified in all twelve studies, As the overall excess number of deaths from liver and biliary cancer in all studies was Vf, some hemangiosarcomas may not have been identified. The low numbers must < Iso be considered in light of the limited follow-up times in most studies. The evidence for 1 Ung cancer is less clear. There is an elevation in some st idies, but at a level that does not achieve statistical s i'nificance, except in the 15 year latency population of Vaxweiler et al (1976). This, in part, may be the resu l|t of the low power of many of the SPI-00447 7 studies. Only two hav e an 80% power to detect an overall risk of 1.5 (Beaumon': and Breslow, 1981). Of significance, however, are the very low SMR's in the groups studied by Theriault and Allard (1981), Reinl, et al (1979), and Nicholson et al (1975), cohorts that would be expected to manifest high risk on the basis of the many hemangiosarcomas that were found. The four largest studies, although in so ne cases limited by inclusion of short-term and recent] y employed workers, also are noteworthy for the SMR's 4lose to 100. Where available, data on subcohorts with lor ger latency (> 15 yr) suggest some increased risk. Waxweiler et al (1981) undertook a detailed analysis of the exposure of the se with lung cancer in their previously published study (Waxveiler et al, 1976) in an attempt to identify pa rticular etiological agents. The analysis used a serially additive expected dose model (Smith et al, 1980) in. which a dose measure during each year of exposure was accumulated for each study individual for a variety of potentially carcinogenic agents. The cumulative doses for tiose with lung cancer were compared with those of other individuals in the plant under study.The results showed that the greatest correlation of lung 'cancer was with exposure to PVC dust. Secondarily, expo sure to vinylidene chloride appeared to be important, but only for large cell and adenocarcinoma. The serially additive dose for VC moa|i nomer differed little in those with lung cancer compared to others in the plant, except, possibly, for large cell!1 cancers. Thus, evidence tc date does not establish that VC monomer is an importan lung carcinogen in exposed worker populations, although it is recognized that limited longterm observation has s far been available. In all studies considered here, slight deficit of cases was seen compared to the number expected. In the subcohorts with more than 15 years f nom onset of exposure, an overall excess of 10% was obse rved. If, in addition, one considers a "healthy worke effect," any excess lung cancer would still be conside rably less than the excess of liver cancer. A qualificati on to this conclusion is that no study specifically cons idered cigarette usage. If cigar ette smoking was much less common among VC workers than the general population, higher SMR's would have been seen if smoking specific d ajta were available. However, this SPI-00448 9 Table 4 Observed and expscted deaths from selected causes among vinvL chloride exposed workers Cancer of the brain & central ner ;ous system Cancer of the lvmohatic and hematoooietic svsteo Bercazzl Obser. Ex sect. SMR 1 CO -8)a 125 Obser. Exnect. SMR , 4 (3.0)b (133) Buffler Byren 0 (0 .1) - 2 0 .33 612f 0 (0.5) 0- - Duck. Equitable 12 5 90 203* -- - 20 17.01 124 Fox & Collier 2 3 66 55 9 9.01 100 Masuda Nicholson Ott Re ini 0 (0 15) 1 (0 1) C1000) 1 0 4 C250) 2 1 3 162 0 (0.5) 2 (0.4) (500) 1 (1.6) (63) 15 7.7 214++ Theriault '0 0 6 1 ' 1.67 60 Waxveiler 3 15 yr. latency 3 0 9 329. 0 6 498* 4 2.5 159 + <0.05 -* t+ < 0.01 4 ( ) " Expected estima ted from the ratio of age standardised O.S. rates ICS 1J93/ICB 140-205. b (, .) " Expected estlma1tied from the ratio of 1950-1969 D.S. rates ICS 200-2105/ICS 140-250. confounding exposures precludes definitive statements, The overall excess of such malignancies (about 10) is also much less than those from primary hemangiosarcomas of the liver. EFFECT OF REDUCTION OF EXPOSURE TO VC As mentioned previously most mortality studies followed populations only to th 1972-1975 period. No data exist on the risk to previous ly exposed populations after cessation of exposure in 1 S'74, although hemangiosarcomas have been noted among retir ees. We have recently completed a follow-up through 1981 of the population reported in 1975 (Nicholson et al, 1975) to determine whether a high risk of liver cancer continu es, following significant reduction in exposure. The origi nal group employed at a VC polymer- SPI-00449 11 pathological review cf all available specimens has not been completed.) Among the 44 deaths that occurred in the Niagara Falls cohort, 6 were from primary cancer of the liver, including 5 hemangiosarcomas. Three of the hemangiosarcomas occurred in the period prior to 1974 and 2 subsequently. Similar findings occurred among the smaller group in West Virginia . Here, of 36 deaths, 4 were from hemangiosarcoma, all of which occurred subsequent to 1974. Thus, the risk of neoplastic VC disease continues undiminished, even though rxposures to the monomer have been significantly reduced. The combined data from both groups are shown in Table 6 and demonstrate an excess risk of cancer, which is total.ly accounted for by the enormously increased risk of liver malignancy observed in each time from onset of exposui e category. The excess lymphomas which achieved signifi :ance at the p < 0.05 level in the Niagara Falls group lise significance when combined with the data from South Charleston. A deficit of lung cancer was observed in both utudy groups and brain malignancies were about equal to the number expected. 1 It is not certaii. whether the results of these two plants will be reflected in the results of other plants in future" years. ; The Sovth Charleston plant was the first facility to commercially produce VC. The New York plant opened immediately following the cessation of World War II. Thus, we are observing effects in populations that include many individua Is with long times from onset of exposure. There is no information on whether the exposures in these two piants were significantly different from those of the ma ority of other VC polymerization facilities. It is known that pre-1974 exposures in the New York plant were s ifficiently high to cause loss of consciousness to some :ndividuals (4.5% of those examined in the clinical surve of 1974) (Lilis et al, 1975). MORBIDITY AND CLINICAL FINDINGS AMONG VC-EXPOSED WORKERS Clinical abnormalities from VC exposure predated by 25 years the documentation of its carcinogenicity. Vari ous VC-related abnormalities were reported in Eastern European literature, including hepatomegaly (Tribukh et al, 1949), angioneurosis (Filatova and Gronsberg, 1957), osteolytic lesions of distal phalanges (Smirnova, 1961), Raynaud's phenomenon and sclerodermalike skin lesions (Suciu et al, 1963). However, VC disease was not seri- 0J (ft SPI-00450 heavily exposed individuals, the portal hypertension and hepatic fibrosis often progressed after cessation of exposure (Martin et al 1974). The histology of malignant and nonmalignant liver disease has been well described by Popper and Thomas (1975 I Thomas et al, 1975), who suggested the possibility of an interrelationship between hemangiosarcoma and the p roliferation of sinusoidal lining cells and hepatocytes seen in VC fibrosis. Lelbach and Marsteller (1981) have also noted that the vast majority of hemangiosarcoma cases have appeared on a background of some degree of hepat:.c fibrosis. The implications of these suggestions for a hemangiosarcoma dose-response relation are uncertain. During 1974, extensive studies were undertaken by the Environmental Sciences Laboratory of the total workforces of three polymerization plants in the states of New York, Michigan and West Virginia. The results from the New York plant (Lilis et al, 1975) indicated the presence of acroosteolysis in heavily exposed individuals. Hepato- and splenomegaly or hepatic tenderness was commonly observed and associated with duration of exposure and elevated alkaline phosphatase levels. Sixty-four of 354 had an enlarged or tender liv r or spleen and of these, 41% had elevated alkaline phosphatase. Liver function tests were not particularly revealing, except for a correlation of elevated alkaline phosphatase levels with duration of exposure. Additionally, carcinogenic embryonic antigen titers were slightly higher among vinyl chloride exposed groups than in a smoking matched control population (Anderson et al, 1978). Tamburro and Greenberg (1981) have evaluated the effectiveness of federally mandated screening tests for workers. Figure 1 shows the re sults on specificity aid sensitivity for 78 individuals with hepatic status determined by biopsy. ICG clearance had the highest combiner sensitivity and specificity, with SGPT the second most useful test. Elevated alkaline phosphatase had the greatest specificity of all tests, particularly for chemically-induced liver injury, but was lacking in sensitivity, SGOT and GGPT were of limited use because of their low sp cificity for chronic liver disease, They recommended the u: e of ICG clearance for screening, to be followed with a kaline phosphatase determinations for those with altered dlearance. SPI-00451 reported that approxinately 20% of VC/PVC workers with high' exposures to PVC dust had abnormal X-rays, which correlated with duration of exposure and, also, with cigarette smoking. In contrast, only 4.7% of individuals in a PVC plant with lew dust levels had abnormal X-rays. In addition to "typics 1 pneumoconiosis," a granulatomous reaction to PVC dust has been reported (Arnaud et al, 1978). Miller et al ( 1975) have observed pulmonary function abnormalities (a neduction i..n.. twh..e^ r..a. tios FEV /FVC .a..n..d. MMF/predicted MMF) in both smokers and non-smokers heavily exposed to PVC dust (and also to VC monomer). Maltoni and Lodi (1981), observed j'reater percentage of abnormal sputurn cytological results among VC exposed workers compared to several other groups of manufacturing workers or miners, Only workers in the chromium industry demonstrated a greater proportion of alonormal cells. Ducatman et al (1975) have observed an increased frequency of chromosome abnormalities in the lymphocyte cultures of VC workers. Most of the abnormalities were "unstable" changes, si.ch as fragments, dicentrics, and rings. This was confirmed by, Purchase et al (1978), among others. Some of the group studied by Purchase w^Jtresampled 18 and 42 months later (Anderson et al, 1980). In those studied during January 1976, the frequency of abnor malities was increased in those who continued VC/PVC employment, but decreased in those who left the industry. In January 1978, no increased frequency was found in any worker. The authors attributed the decrease to the reduc tion in VC exposure. HEALTH HAZARDS IN THE PVC PROCESSING INDUSTRY Prior to identification of hemangiosarcoma in VC polymerization workers, little effort was made to control either the concentration of residual monomer in PVC dust or exposures to dust and VC that occurred in the various forming operations of :he PVC fabricating industry. VC concentrations in excess of 10 ppm occurred frequently. While these concentrations were significantly lower than those of the polymerization industry, the much greater employment in the processing industry (hundreds of thou sands vs. tens of thousands in the polymerization work) raised concern for population health effects, particularly for malignant disease lor which no threshold was known. However, only two hemangiosarcomas have been documented in SPI-00452 onset of exposure. Considering the numbers of observed and expected deaths ir all studies, it would appear that the excess of malignaa: ncies at nonhepatic sites is less than the excess of liv r tumors. Data presented elsewhere in this volume (Nicho son and Henneberger, 1983) suggest that exposure reductiors in 1974 may have virtually elimi nated the VC-associat ad risk of liver cancer if the current U.S. standard is met. To the extent that VC exposure is associated with other cancers, a similar risk reduction would be expeaji lcted. Raynaud's phenomenon, acroosteolysis, sclerodermalike skin lesions, hepato- and splenomegaly with noncirrhotic hepatic fibrosis, and ssevere portal hypertension have been associated with past heavy exposures to VC. Evidence exists that the liver disease and portal hypertension may progress following cessation of exposure. However, all of the above syndromes were found largely in heavily exposed individuals. Their occurrence would be much less likely in workers exposed only to concentrations currently allow ed. Pulmonary deficits, X-ray abnormalities, and, per haps, lung cancer have been associated with VC/PVC expo sure. Because of the possible contribution of PVC dust to these findings, engineering controls during polymer dry ing, bagging and usage are warranted. REFERENCES Anderson HA, Snyder MS, Lewinson T, Woo C, Lilis R, Selikoff IJ (1978). Levels of CEA among vinyl chloride and polyvinyl chloride exposed workers. Cancer 42:1560-1567. Anderson D, Richardson DR, Weight TM, Purchase IFH, Adams WGF (1980). Chromosomal analyses in vinyl chloride exposed workers: Results from analysis 18 and 42 months after an initial sampling. Mutation Res 79:151-162. Alexander V, Leffingwell SS, Lloyd JW, Waxweiler RJ, Miller RL (1980). Brain cancer in petrochemical workers: A case serie:; report. Am J Ind Med 1:115-123. Arnaud A, Pommier de Santi P, Garbe L, Payan H, Charpin J (1978). Polyvinyl chloride pneumoconiosis. Thorax 33:19-25Barnes AW (1976). Vinyl chloride and the production of PVC. Proc R Soc Med 61:277-281. Baxter PJ, Fox AJ (1970). Angiosarcoma of the liver in P.V.C. fabricators. Lpncet 1:245. Fox AJ, Collier PF (1577). Mortality experience of work ers exposed to vinyl chloride monomer in the manufacture of polyvinyl chlorice in Great Britain. Brit J Ind Med 34:1-10. Greenwald P, Friedland:r BR, Lawrence CE, Hearne T, Earle K (1981). Diagnostic sensitivity - an epidemio logic explanation fo : an apparent brain tumor excess. J Occ Med 23:690-694. Jones JH (1981). Wor cer exposure to vinyl chloride and polyvinyl chloride. Environ Health Persp 41:129-136. Lelbach WK, Marstelle;: HJ (1981). Vinyl chloride-asso- ciated disease. In: Ergebnisse der Inneren Medizin und Kinderheilkunde, Bd 47, Advances in Internal Medicine and Pediatrics. P. Frick et al Eds. Springer-Verlag, Berlin. [,Lilis R, Anderson :u cholson W, Damn S, Fischbein AS, Selikoff IJ (1975). Prevalence of disease among vinyl chloride and polyvinjyl chloride workers. Ann NY Acad Sci 246:22-41. Lilis R, Anderson H, Mliller A, Selikoff IJ (1976). Pul- monary changes amor g vinyl chlroide polymerization workers. Chest 69:29 5S-303S (suppl). Lloyd JW (1975). Anj iosarcoma of the liver in vinyl chloride/polyvinyl thloride workers. J Occ Med 17:333-334. y Maltoni C, Lodi P (19(81). Results of sputum cytology among workers exposed to vinyl chloride monomer and poly(vinyl chloride). Environ Health Persp '41:85-88. Maltoni C, Lefemine G, Ciliberti A, Cotti G, Carretti D (1981). Carcinogenidity bioassays of vinyl chloride monomer: A model of :risk assessment on an experimental basis. Environ Health Persp 41:3-29. Marsteller HJ, Lelbach WK, Muller R, Juhe S, Lange CE, Rohner HG, Veltman G (1973). Chronic toxic liver damage in workers of PVC producing plants. Deut Med Wochschr 98:2311-2314. Marsteller HJ, Lelbach WK, Muller R, Gedigk P (1975). Unusual splenomegalic liver disease as evidenced by peritoneoscopy and guided liver biopsy among polyvinyl chloride production workers. Ann NY Acad Sci 246:95-134. Mastrangelo G, Saiu B, Marcer G, Piazza G (1981). Epidemiological study o : pneumoconiosis in the Italian poly(vinyl chloride) industry. Environ Health Persp 41:153-157. gpi.00454 1 21 Sucui I, Drejman I, Valaskai M (1963). Contribution to the study of v(L nyl chloride disease. Med Interna 15:967978. Tamburro CH, Greenberjg R (1981). Effectiveness of Fede- rally required medi cal laboratory screening in the de tection of chemical liver injury. Environ Health Persp 41:117-122. Theriault G, Allard (1981). Cancer mortality of a group of Canadian workers exposed to vinyl chloride monomer. J Occ Med 23:671-676. Thomas LB, Popper H, Jerk PD, Selikoff IJ, Falk H (1975). Vinyl-chloride-induced liver disease. From idiopathic portal hypertension (Banti's syndrome) to angiosarcomas. .N Engl J Med 292:17--12 Tribukh SR, Tikhomirova NP, Levina SV, Koslov LA (1949). Working conditions and measures for their sanitation in the production and utilization of vinyl chloride plas- tics. Gigiena Sanit 10:38-44. Waxveiler RJ, Stringer W, Wagoner JK, Jones J (1976). Neoplastic risk amon;; workers exposed to vinyl chloride. Ann NY Acad Sci 271: vO-48. Waxveiler FJ, Smith AH Falk H, Tryoler HA (1981). Excess lung cancer isk in a synthetic chemicals plant. Environ Health Persp 41:159-165. Wilson RH, McCormick WE, Tatum CF, Creech JX (1967). Occupational acroosteolysis. J Am Med Assoc 201:577-581. SPI-00455 I John T. Barr Manager, Regulatory Response (215) 481-8343 P tie (h ____ AIR / PRODUCTS ^ " - U2Z fa fa. / a fy^t> er$ %> Xw - SPI-00456 Federal Register / Vol. 51, No. 19 / Wednesday. January 29. 1986 / Proposed Rules 3747 able tiles using .ass. mvl re are a titutes e stitute lies. .able for nt men! reed a price to that ent-wood ~1 oeslos; and vood hie in is-cemenl tge over r concrete, eet may nee than towers, r ceramic ule products are cost competitive and . Fibrous glass appears to be ,,rc suitable for most applications. There considerably less hazardous than six' also a number of products that can asbestos based on (1) morbidity and substitute for asbestos-cement sheet as mcrtality studies in workers, (2) in vivo .1 !..liora'ory desk top and fume hood and in vitro experimental data. (3) the bench. I towever. it appears that ore er of magnitude lower exposure i mnp.irabiy priced products may not potential in the workplace, (4) the ei'iv match the qualities of asbeslus- ger orally less respirable nature of the j ir.unt sheet in these applications. air jorne fibers, and (5) the less durable h. Asbestos-cement shingles. There nature of the fibers in the lungs. no substitutes for asbestos-cement t. Mineral wood does not appear to shingles for both roofing and siding present the significant risks that applications. The primary substitutes for astesios does based on (1) limited .islmslcs-cement roofing shingles are aninal data and morbidity and isohult-fiberglass composition shingles, mo -tality studies for workers, and (2) cedar wood shingles, and various the lower exposure potential in ihe sviuhetic and natural tiles, such as wo kplace. Monra; roofing tile and concrete tile. c Ceramic fibers do not appear to Asphalt-fiberglass composition shingles pro tent a comparable risk to that of cost about half as much as asbestos- asbestos based primarily on (1) the cement shingles in terms of purchase moderate workplace concentrations, .md installation costs but have only anc (2) the specialized applications about half the operating life. Cedar which include its encapsulation or wood shingles have a slightly greater incorporation into products. cost then asbestos-cement shingles but d Carbon/graphite fibers are have a greater operating life. probably not a significant health risk Substitutes cor asbestos-cement bas :d on the (1) use of coatings on the shingle siding include wood, wood fibers which may reduce their shingles, aluminum siding, PVC siding, res; irability, and (2) low intrinsic stucco or concrete block, vinyl, and res; irability characteristics. brick. Aluminum and PVC siding are e. Aramid fibers appear to present both virtually identical to asbestos- relatively low risk because they are cement shingles in terms of price and bas caily nonrespirable as currently durability. Cedar shingle siding is also very competitive in terms of price, but it produced and processed. f. Polyethylene and polypropylene is somewhat less durable. pulps and fibers appear to present The total substitute market for both applications is approximately as follows: rela ive'y little risk since they appear to be rilatively nontoxic and non espirable. Attapulgite has large general AAl'l.inVrls.iu*.cpCimokhd.sianitldpuitl/iremnfoi.bgd..e.su...ir.cd..g.t.i.s.ln.a...g...s......s..........................................................................................................3.......0........-....3......5............p.......e....r.55.c..--e115n0005tppppeeeerrrrcccceUeaseeeeuvxdnnnnSipbddtttt.osietmstinioutciunnreet,eesaspfutoomtgatrgeapaeynusstlbptigaseriletstebshtoeuaissntt.taanlotvitttaatliapelaumbhlglaaeiztjeoarrfdro. mIn 2. Possible hazards of substitutes. h. Polyvinylcholoride does not appear EPA has analyzed available data on the to pi esent a health hazard comparable health effects of major substitutes for to a: bestos. although vinyl chloride, the asbestos (Ref. 14). Some of the timer used to produce substitutes such as wood-based polyvinylchloride. is a carcinogen. The products (e.g.. cellulose fiber products) poly i-inylchloride product itself presents end construcliun products made of brick little risk and workplace exposures are and concrete appear to present little appt rently adequately controlled. risk. While other substitutes present i. Ductile iron pipe does not present a some risk. EPA has concluded that the healI h hazard comparable to that of available information suggests that none asbestos. of ihe substitutes appear to present as EFA recognizes that some asbestos -real a potential for risk to human subs;itutes may be new chemical health as asbestos. EPA made extensive substances for which a premanufacture use of the work of the National Research notice (PMN) must be submitted under Council and agrees with their conclusion secti t>n 5 of TSCA. A goal of EPA's PMN hat: "Current population risk from review program is to encourage the ''posures to the various substances development of new chemical 'niisulnred. including fibrous glass, sub antes that are less hazardous than '".ipnlajte. and carbon fibers, appears the epemical substances they replace. |1,1 he much less than for risk from EPA encourages the development of less I'^bestos. especially chrysoiilo" (Ref. 6). haz.i tlous new chemical substances as ' conclusions of EPA's analysis of asbeitos replacements. Potential ' 1 fi' substitutes follows. deve opers of new chemical substances `i intended as asbestos substitutes may wish to discuss their plans with EPA during a prenotice consultation. Such a consultation can be arranged by contacting the Prenotice Communications Coordinator by telephone at (202-382-3745) or by writing to the Prenotice Communications Coordinator. Chemical Control Division (TS--794), Environmental Protection Agency. 401 M St.. SW.. Washington. DC 20460. Through a prenotice consultation, EPA can inform potential PMN submitters of legal requirements, possible EPA health concerns about the substance, and possible test data that EPA may believe necessary to evaluate the risk potential of the substance. During a prenotice consultation and any PMN review of a new chemical substance that is intended as a substitute for asbestos, EPA will consider the relative risks presented by asbestos and potentially presented by the asbestos substitute. EPA will make every reasonable effort to provide prompt and clear information concerning the likely result of PMN review in view of EPA's policy of encouraging les3 hazardous substitutes for asbestos. D. Economic Effects of Proposed Rule This portion of the preamble presents EPA's determination of the "reasonably ascertainable economic consequences of the rule" as required by section 6(c)(1)(D) of TSCA. EPA has prepared a "Regulatory Impact Analysis of Controls on Asbestos Products" (Ref. 3) which analyzes the potential economic impact of this proposed rule. The economic impact is summarized and explained below. Estimated costs are mainly from 1981 data obtained under EPA's section 8(a) asbestos reporting rule (40 CFR 763.60). Some of the data were adjusted to reflect more current information on production of asbestos products. Specifically, EPA gathered more current information on the use of asbestos cluthing and asbestos flooring felt and then adjusted the estimated costs and benefits of the rule to reflect declining use of these products. The sources of the information are noted in the record for this rule. The costs are presented as the net present value of costs incurred due to changes in asbestos product production between 1985 and 2000. Costs are likely to be overstated since the baseline production levels used in the cost model probably overstate production in the future. In addition, the cost estimation model assumes that the relative prices of substitutes for SPI-00457 m memorandum ? 7-r ' -J o ' W7 T<&oy Gottesman, Pat Tfcner, Margane : Rogers REFERENCE Cathy Ifendazzo, Ellen Robinson, J Hie Cain Ff^ngaret Rita DATE: February 6, 1986 EPA: Asbestos; Proposed Mining and Import Restrictions and Proposed Manufacturing Importation and Processing Prohibitions (51 FR 3738) The Environmental Protection Agency proposed a rule January 29 to prohibit the manufacture, importation and proo:issing of asbestos in certain products and to phase out the use of asbestos in all other products. Anang its provisions, the proposal would ban the following products: asbestos-cement pipe and fittings, roofing felts, flooring felts, v IT l yl-asbestos floor tile and asbestos clothing. EPA is also considering phas ng out the manufacture, importation and processing of all asbestos products. Ch page 51 FR 3743 there are three tables showing occupational exposure data for manufacturing, ambient exposu re data for manufacturing, and exposure data for installation, use, repair, and di sposal in relation to certain asbestos products. Sane of the asbestos products lis :ed include plastics, PVC siding, vinyl flooring. and surface coatings. Gonments are due by April 29 1986. Public hearings will be held around ftey 14, 1986, but a definite date has not yet been decided. You may call EPA's TSCA Assistance Office to get the exact date and location at (202) 554-1404. cc: John Dibeck THE SOCIETY OF THE PLASTICS INDUSTRY, INC. SPI-00458 Wednesday January 29, 1986 Part II Environmental Protection Agency 40 CFR Part 763 Asbestos; Proposed Mining and Import Restrictions and Proposed Manufacturing Importation and Processing Prohibitions SPI-00459 JAMUM li 'iWi f f i t 3/38 Federal Register / Vol. 51. No. 19 / Wednesday. January 29. 1986 / Proposed Rules lONMENTAL PROTEC aENCY 40 CFR Part 763 [OPTS-62036; FRt 2947-3] Asbestos; Proposed Mining and Import Restrictions and Proposed Manufacturing, importation, and Processing Prohibitions agency: Environmental Protection gency (EPA). ion: Proposed rule. SUMMARY: EPA is proposing a rule/fader sections of the Toxic Substances ContioHA^t (TSCA) to prohjfrtroe manufactiJSainportalLag^nd processing of asWSrflsin certain products and to phase out the use of asbestos in all other products. The products EPA proposes to ban are asbestos-cement pipe and fittings, roofing felts, flooring felts (and feltbacked sheet flooring], vinyl-asbestos floor tile, and asbestos clothing. Under this rule, EPA would also allow only those persons with permits issued by EPA to mine or import asbestos for use in products that are not banned. Eventually, all mining or importation of' asbestos would be prohibited, except for that mining or importation allowed under an exemption process. EPA is proposing this rule to reduce the serious unreasonable risk to human health presented by exposure to asbestos. As an alternative, EPA is considering prohibiting the manufacture, importation and processing of categories of asbestos products at staged intervals. EPA is considering banning the manufacture, importation, and processing of asbestos construction products and asbestos clothing soon after the rule's promulgation with the category of asbestos friction products banned about 5 years later, and other asbestos products banned at a later time. EPA believes that this alternative approach would also be an effective way of reducing the serious unreasonble risk presented by exposure to asbestos and specifically requests comment on a staged ban of asbestos product categories. Finally, under both this alternative and the proposed approach, EPA is considering requiring labeling for all asbestos products that are not banned, including products manufactured pursuant to permits issued by EPA during the phase-down period, or pursuant to an exemption process. The Agency requests comments on the feasibility and effectiveness of such a requirement. OATtS: Public hearings will be heid begii ining approximately May 14, I960. The ixact times and locations of the hear ngs will be available by calling EPA's TSCA Assistance Office. Com nents on this proposed rul* and requests to participate in the informal hearings must be submitted by April 29, 1988. Reply comments made in response to iIsSq! uUel s raised at each hearing must be subn itted no later than 1 week after the close of that hearing. adore:SS: Since some comments are expe :ted to contain confidential busir ess information, all comments should be sent in triplicate to: Document Conti ol O( fficer (TS-793), Office of Toxic Subsja;nces, Environmental Protection Agen :y, Rm. E-209. 401 M St SW, Was) ington, DC 20460. Co: am: ents should include the docket contrpl number OPTS-62036. Nomc mfidential comments and noneqnfidential versions of confidential comn ents received on this proposal will be a v lilable for reviewing and copying from a.m. to 4 p.m.. Monday through FridaV,, excluding legal holidays, in Rm. E-107 at the address given above. FOR FURTHER INFORMATION CONTACT. Edwa d A. Klein. Director. Offioe of TSCA Assistance (TS-799), Office of Toxic Substances. Environmental Protecjtion Agency. Rm. E-543, 401 M St. SW,, tfVashington. DC 20460, Toll free: (800-4124-9065)., In Washington, DC (554-1 104), Outside the USA: (Oper t tor--202-554-1404). SUW. -MENTANY INFORMATION: I. Intrt duction Asb istos. since the advent of its large scale t se, has resulted in thousands of painfu u premature deaths from lung cancel and other diseases. Because of the wi lespread use of asbestos and its partici lar nature, piecemeal control of the ris ts it presents is not satisfactory; only elimination of asbestos to the extent feasible will produce acceptable reduct on of risks. Prevention of further deaths therefore, requires forceful, integrated action against asbestos risks. To achieve this end, EPA has established a coordinated asbestos progra n. aimed at controlling exposure toiasbfs tos from products already in use and e lijninating risks from future uses. Thei ru e EPA is proposing today, which would 3an certain uses of asbestos and phase i iut all other uses, forms a central element of this program. Regulatory altema;lives, which are discussed in this notice ind which involve staged bans of varioui asbestos product categories, could ajlso form a central element of the prograrh The risks EPA is addressing in this proposal and its overall asbestos program are serious and well documented. Asbestos is a known human carcinogen that causes lung cancer, mesothelioma (a cancer of the chest and abdominal lining) and is also linked to other cancers. It has been estimated that 3.300 to 12.000 cancer cases a year occur in the United States as a result of past exposure to asbestos; almost all of these cancer cases are fatal. In addition, asbestos causes asbestosis (a serious lung disorder). About 65.000 persons in the United States are estimated to be suffering from asbestosis today. Assuming current exposure levels. EPA estimates that about 2.560 persons will develop lung cancer or mesothelioma as a result of exposure to asbestos from products made over the next 15 years, unless asbestos exposures are reduced through regulatory action. As discussed later, even with a relatively low workplace PEL of 0.2 f/cc. EPA estimates that almost 1,325 cancers will result from . asbestos products made over the next 15 years. The underlying data upon which the risk assessments for asbestos are based come from a number of high quality epidemiologic studies. Unlike most potential carcinogens, asbestos has been studied often and thoroughly for its effects on humans. Asbestos presents a particularly insidious threat because of the unique quality of its fibers. These fibers are small, colorless, odorless, often invisible except through a microscope, and indestructible in most uses. They can be transported on clothes and other materials, and they have aerodynamic features that allow them to be easily suspended and resuspended in the air and to travel long distances. Once released, asbestos fibers are difficult to detect and contain, and they readily enter the ambient air. Thus persons are exposed not only at the time and place of release, but long after the release has occurred and far from its source. There is constant renewal of risk as asbestos fibers reenter the atmosphere repeatedly over time. Despite the known risks of asbestos, substantial amounts of the material are still mined, imported, and used in commercial products. About 240.000 metric tons, for example, were used domestically in 1984. Hundreds of products are still made with asbestos, including paper and textiles, cement pipe and sheets, tiles and felts, and automobile brakes. Asbestos fibers are released to the air at many stages of the commercial life of these products. Typical activities that lead to the ?! SPI-00460 Federal Register / Vol. -1' Nc: 19 / Wednesday, [anuarv 29. release of asbestos include the mining of asbestos, fiber processing into products, installation of products (e g., the sawing, drilling, and sanding associated with asbestos-cement products), product use (e g., release of fibers during use of asbestos cloth), product maintenance (e g., buffing and scraping of vinylasbestos floor tile or repair of asbestoscontaining brakes), dismantling and removal of products (e.g., removal of asbestos roofing felts), and disposal. Release of fibers from these activities is substantial, resulting in exposure to both workers and non-workers. EPA estimates that about 700 metric tons are released to the air during mining and milling each year, about 100 metric tons during product manufacture, and about 18 metric tons from landfills. These estimates are probably low because they do not include releases from secondary fabrication of such products as millboard and asbestos-cement sheet, much of which is done in small shops with inadequate emission controls. Observations that levels of asbestos in the air near manufacturing plants and in cities are considerably greater than rural background levels seem to confirm that these releases occur and are significant. Release of asbestos fibers occurs not only in the manufacture and processing of asbestos products, but also in their use and maintenance. This release can occur without the knowledge of the user or maintenance personnel. For example, construction workers tap into asbestos- cement pipes already in place. The workers often do not know that the pipe contains asbestos and thus do not take steps to limit fiber release. Similarly, significant releases occur as a result of the use and repair of asbestos brakes and other friction products, which constituted about 22 percent of the total asbestos market in 1984. Ambient levels of asbestos are elevated near freeways, presumable due to release from asbestos brakes. Thus, the manufacture, processing, and use of asbestos products leave a legacy of asbestos in the ambient air. This ambient loading, while difficult to quantify, is a significant problem. The National Academy of Sciences, after analyzing studies of outdoor air. estimated typical concentrations of asbestos in outdoor ambient air in urban areas to be approximately 0.00007 f/cc (Ref. 6). Many millions of people are daily exposed to these levels of asbestos in the air. The National Academy of Sciences has also estimated that persons in urban areas face a lifetime risk of between about 1 in 100.000 to about 7 in tOO.OOO of developing cancer as a result of asbestos in the ambient air Sef ^ afndU,sldeof buddings [He . (i . Therefore, any comprehensive St[a,,ep `ke into accoZ the pt tential for exposure during ;he entire lifecycle of asbestos products To late. EPA has focused its attention primarily on asbestos in buildings, a majot source of asbestos release mio the ambient environment. In the 1970s. EPA banned the use of sprayed-on asbestos and asbesto-containing pipe lagging undet the Clean Air Act. and since then has ti ken steps to reduce risks from asbestos already in place in buildings, ft has i; sued an air standard to reduce emissions from asbestos removal and renovation projects in buildings: issued a rult requiring inspection of schools for friable asbestos; and established an exter sive technical assistance program, whic. i provides guidance to public and private building owners on the ident fication and safe removal of asbei tos. EPA has also proposed an immediately effective regulation to protect State and local public employees who ake part in asbestos abatement activ ties. Th >se actions are primarily remedial, addr tssing risks from asbestos already in pi; ice: they do no address the subs antial risks that will result from the continued manufacture and use of asbestos. Several other Federal agencies have already taken steps that partial';, redu :e these risks. The Occupational Safe y and Health Administration (OSHA) has an occupational standard for asbestos with a permissible exposure limit (PEL) of 2.0 f/cc. OSHA has proposed to lower this standard to eitht r 0.2 or 0.5 f/cc. In addition, the Con: mmer Product Safety Commission (CPJ C) has banned use of respirable asbestos in consumer patching com sounds and artifical emberizing mat rials. However, substantial risk to worliers and the general population remains. For this reason. EPA believes that only a major regulatory initiative undi sr TSCA leading to the eventual elimination of most asbestos product marufacture and importation can satisfactorily reduce the overall risk io all segments of the population. T le limitations of exposure-based regi lations in preventing asbestos-fiber reie ase. and the need for more con prehensive action under TSCA. are illu: trated by the use of PELs to control woikplace exposure. In the first place, it app:ars infeasible to set a PEL for asb sstos low enough to reduce risk to a satisfactory level. Even at 0.2 f/cc. the lowest PEL proposed by OSHA. OSHA, usii g the same lung cancer and me: othelioma models used by EPA. estimates that about 7 in 1.000 asbestos workers may die from an asbostos- reiaied disease. Furthermore it is unreasonable Io assume complete compliance with a PEL of 0.2 f/rr especially given the nature of the asbestos industry. Manv of the worker, exposed are in the service and construction industries, where worksite, change frequently and the worker population is transient. Aiso. woryers often do not know they are exposed to asbestos and therefore will not take the necessary precautions. As a result. PELs and other exposure controls are difficult to apply and enforce. Beyond these considerations, a workplace-based approach does not address risks lo the general population. EPA estimates that, even if OSHA reduces the PEL to 0.2 f/ cc. almost 1.325 cancers will still result from asbestos products made over the next 15 years. Because of this residual risk. EPA is proposing under section 6 of TSCA a ban on the manufacture, importation, and processing of asbestos-cement pipe and fittings, roofing felts, flooring felts (and felt-backed sheet flooring), vinylasbestos floor tile, and asbestos clothing. These uses would be banned because safer, economically competitive substitutes are available, and because these asbestos uses are likely to contribute large amounts of asbestos to the ambient environment or present disproportionately high risk. In addition, EPA is proposing to establish a permit system to phase out all other asbestos products. Under this system, EPA would allocate permission to mine or import a specific volume of asbestos to current miners and importers. The amount of asbestos a miner or importer would be allowed to mine or import would decline every year until after 10 years no mining or importation would be allowed, except under a specific exemption. This permit system would allow the market to allocate asbestos, based on the availability and cost of asbestos substitutes. After 10 years. EPA would put in place an exemption system for those asbestos applications for which no substitutes had been developed. EPA anticipates that there will be Few such applications, because the permit system would create strong incentives for the development of substitutes. EPA is also considering a requirement that all asbestos products that are not banned be labeled as containing asbestos. This would apply to products made pursuant to permits issued by EPA to mine or import asbestos, and to products made pursuant to an exemption process. In encouraging the development of substitutes. EPA will be promoting a SPI-00461 3740 Federal Register / VoL 51. No. 19 / Wednesday, January 29. 1986 / Proposed Rules significant reduction in risk. Currently, all products that are replacing asbestos in its many uses appear to present lower risk. However. S'A will monitor the development of substitutes during the.. 10-year phase-down period, and will use section 4 of TSCA to require testing of substitutes if necessary to ensure their safety. As explained more fully later. EPA is also actively considering other approaches to carry out a regulatory policy of phasing out the manufacture importation, and processing of asbestos products. Approaches under consideration include banning categories of asbestos products at staged intervals. Two categories under consideration are asbestos construction products and asbestos friction products. Under this approach. EPA would ban the manufacture, importation, and processing of all asbestos products within the category at the same time. EPA is considering this category approach because products within each of the categories have similar exposure patterns, raise similar exposure control issues, and have similar substitutes. EPA believes that it may be good public policy to ban such categories of products at the same time. This approach would address similar exposure patterns in the same way and treat all parts of an industry sector similarly. In addition, both the construction products category and the friction products category contain products that could substitute for other products in the category if all are not banned. Thus, a ban of the entire category may be necessary to reduce risk most effectively. EPA also considered referring asbestos risks to OSHA and CPSC under section 9 of TSCA. EPA decided against this approach because OSHA and CPSC. in EPA's opinion, cannot adequately reduce the risk, given their authority and current control technologies. These agencies cannot comprehensively reduce the total volume of asbestos in commerce and cannot protect all of the many population groups at risk. Thus, action by these agencies under their separate .authorities would still leave a large residaal risk to workers and the general population. EPA concluded, therefore, that this approach would not adequately address the risks to society posed by the continued manufacture, processing, and use of asbestos-containing products. EPA is convinced that restrictions on the manufacture, importation, and processing of asbestos and asbestos products is the surest and most effective strategy for eliminating these risks. II. B. ickground EF A announced that it was exploring poss ble use of TSCA to reduce the risk to hi man health from exposure to asbe itos m an Advance Notice of Propped Rulemaking (ANPR| published in th Federal Register of October 17, 1979 [44 FR 00061). Following publication of the A.NPR. EPA invei tigated industrial and commercial uses of asbestos. Under section 8(a) of TSCA. EPA promulgated an asbestos reporting rule under 40 CFR 783.00 publi ihed in the Federal Register of July 30. IS 62 (47 FR 33207}. This rule required mine's, millers, importers, and procissors of asbestos to report information concerning (1) quantities of asbe: tos used in product manufacture, (2) eriployee exposure to asbestos. (3) wasti1 disposal practices, and (4J emiss ion control practices. The infon tation reported under that rule has been used with other data to evaluate the ri ;ks and benefits of asbestos use. Urn ler section 21 of TSCA. a person may petition EPA to initiate a proce :ding for the issuance, amen iment. or repeal of a rule under varioi is sections of TSCA. On June 21, 1979, ZPA was petitioned to prohibit the future use of asbestos-cement pipie in water systems. EPA granted that psetitu n by a notice published in the Feder il Register of October 18.1979 (44 FR 60 55). On September 12.1964. the Natur il Resources Defense Council (NRDi^J petitioned EPA to prohibit furthe use of asbestos in motor vehicle brake i. EPA granted that petition by a notice pmblished in the Federal Register of Dec ember 18.1984 (49 FR 49311). This prop** >al is in part a result of the procei dings conducted after granting those wo petitions. EPA has identified effecti/e substitutes for asbestos-cement pipe a id is proposing to ban that product. EPA analyzed the availability of sub ititutes for asbestos in brakes but is not irepared to propose an immediate ben. E Tective substitutes are still not availa >le for many applications of asbestss in brakes. Instead. EPA is propos ing to phase out use ofasbestos in brakes and use market forces to encouiage the more rapid development of subi titutes. As an alternative. EPA is considsring a ban of asbestos friction products about 5 years after this rule is promu gated. This alternative would also er courage the rapid development of substit Jtes. III. Rep uiatory Assessment Sect on 8 of the TSCA authorizes EPA to prohibit or limit by rule the amount of a chemical substance which may be manufactured, processed, or distributed in commerce if EPA finds that there u reasonable basis to conclude that the * manufacture, processing, distribution!, commerce, use. or disposal of the * chemical substance, or any combmatL*. of such activities, presents or will present an unreasonable risk of injury t health or the environment. Under section 6(c)(1) of TSCA. B>/\ must consider the following factors when determining whether a chemical substance or mixture presents an unreasonable nsic (1) The effects of such substance or mixture on health and the magnitude of the exposure of human beings to such substance or mixture. (2) The effects of such substance or mixture on the environment and the magnitude of the exposure of the environment to such substance or mixture. (3) The benefits of such substance or mixture for various uses and the availability of substitutes for such uses. (4) The reasonably ascertainable economic consequences of the rule, after consideration of the effect on the national economy, small business, technological innovation, the environment, and public health. After considering the above factors, EPA presents the following findings concerning the unrestricted mining and importation of asbestos, including asbestos imported in products. A. Health Effects andMagnitude of Exposure to Asbestos 1. Health effects. This unit summarizes the health effects of asbestos. Detailed discussion and assessment of the health effects of asbestos may be found in the "Report to the United States Consumer Product Safety Commission (CPSC) by the Chronic Hazard Advisory Panel on Asbestos" (CHAP) (Ref. 1), "Health Effects and Magnitude of Exposure" in EPA's "Support Document for Final Rule on Friable Asbestos-Containing Materials in School Buildings." (Ref. 4) and the "Report of the (National Research Council) Committee on Nonoccupational Health Risks of Asbestiforra Fibers" (Ref. 0). EPA finds that the adverse human health effects from exposure to asbestos are extremely serious. Asbestos is a known human carcinogen that also causes other lung diseases. Asbestos has been thoroughly examined in numerous epidemiology studies. The life-threatening diseases that have been repeatedly identified are asbestosis, lung cancer, and mesothelioma. Also associated with asbestos exposure in some studies are cancers of the larynx. SPI-00462 Federal Register / Vol. 51. No 19 / Wednesday, fanuary 29, 1986 / Proposed Rules 3741 pharynx, gastrointestinal tract, kidney, and ovary and respiratory dieseases such as pneumonia. Major health effects are discussed below. Lung cancer is currently responsible for the largest number of deaths from exposure to asbestos. It has been associated with exposure to all the principal commercial asbestos fiber types. Excess lung cancer has been documented in groups involved with the mining and milling of asbestos and the manufacture and use of asbestos products. Studies in which the extent of exposure can be approximated provide evidence that lung cancer increase linearly with both level and duration of exposure. Cigarette smoking and asbestos have a strong synergistic interaction in development of lung cancer. Asbestos exposure appears to multiply the underlying risk of lung cancer. Consequently, when exposed to asbestos, the risk of lung cancer for smokers (for whom the risk of lung cancer is already high) is much higher than that for nonsmokers exposed to asbestos. Most persons who develop lung cancer die within 2 year. Many human studies have also shown that exposures to asbestos produce mesotheliomas, which are cancers that occur as thick diffuse masses in the serous membranes (mesothelia) that line body cavities. Mesotheliomas occur in the pleura (the membrane that surrounds the lungs and lines the lung cavity) and the peritoneum (which surrounds the abdominal organs and lines the abdominal cavity). Most persons who develop mesothelioma die within the first 2 years after diagnosis, often after having been in constant pain. Epidemiology studies suggest that the incidence of mesothelioma is related to dose and time from first exposure. Association of mesothelioma with smoking is weak or nonexistent. Asbestos fibers appear, by far, to be the most common cause of mesotheliomas. Asbestosis, which involves fibrosis of lung and pleural tissues, is another serious chronic disease associated with exposure to asbestos. There is no effective treatment for asbestosis and it is often disabling or fatal. Asbestosis is diagnosed from findings which may include radiographic changes, breathlessness, and abnormal lung function. Since some clinical symptoms of asbestosis are similar to those of other fibrosing lung diseases, a history of occupational exposure to asbestos is often a key feature of its diagnosis. Asbestosis can appear and progress decades after exposure to asbestos fibers. Under working conditions where average fiber concentrations in the air were h gh (more than 10 fibers per cubic centimeter (f/cc)) asbestosis has accounted for more than 7 percent of observed deaths (Ref. 11). It is appare ttly less common than lung cancer or mesothelioma at exposures lower tian the current Occupational Safety ind Health Administration (OSHAj) workplace standard of 2.0 f/cc. Some rpcent data on the incidence of asbesti sis appear compatible with a linear ^xposure-response relationship with nt threshold (Ref. 12). However, it is still tonsidered uncertain whether asbesti isis occurs as a result of nonoct upational exposures. In occupational studies where the primary route of exposure is through inhalation, lung cancer and mesotl eliomas usually account for about SO percent of the excess cancers seen among workers exposed to asbest is. However, as noted in the CHAP report (Ref. 1). a number of other principally of the gastrointestinal tract, have been associi ited with asbestos exposure. These ire cancers of the larynx, pharyr x. oral cavity, esophagus, stomai h. colon, and rectum. Statistically significant excesses of cancere of the kidney and ovary have also been shown) In addition, the excess of at all other sites combined is statist: cally significant in some studies. The conclusions from epidemiology studies concerning the health effects of asbest ds are also supported by results f laboratory studies. Animals treated w::.: asbestos have shown increased incide ice of fibrosis, lung cancer, and mesot leliomas. All commercial forms and s veral other types of asbestos are implic ited from a variety of modes of expos i Moi t occupational studies have been conducted on populations exposed to high a rbome concentrations of asbestos for rel itively long periods of time. Howe rer. short-term occupational expos ires have also been shown to increase the risk of lung cancer and mesot lelioma. One group of asbestos factor f workers with less than 2 months of occupational exposure had a twofold increase in lung cancer risk (Ref. 9). In additi an. there are many documented cases of mesothelioma linked to extremely brief exposure to high conce itrations of asbestos or long-term exposure to low concentrations (Ref. 4). Direct ev idence of adverse health effects from non-occupational asbestos exposure also exists. Persons who lived in the households of asbestos workers have ieveioped pleural mesothelioma and a sbestos-related radiographic changes. In an ongoing study, 4 cases of mesothelioma have been diagnosed among 626 family contacts of amosite workers (Ref. 10). These figures are much higher than that expected to he found among the general population. In addition. 35.9 percent of the contacts showed chest x-ray abnormalities as compared with 4.6 percent of control subjects drawn from the same community. A number of mesotheliomas have also been documented among populations whose only identified exposure was from living near asbestos mining areas, asbestos product factories, or shipyards where asbestos use had been very heavy (Ref. 4). An estimated 1.600 cases of mesothelioma occur yearly in the U.S. among various populations exposed to asbestos (Ref. 6). In addition to exposure to asbestos fibers in the air. the general population is also exposed through various oral sources, including drinking water containing asbestos. Because of the potential for oral exposure as well as the excess of gastrointestinal tract cancers that has frequently been found in occupational groups exposed to asbestos in the air, Lhere has been much study of the possible health effects of ingestion of asbestos fibers. Despite those efforts, evidence showing health effects from ingestion is still ambiguous. 2. Cancer risk extrapolation. A9 discussed above, numerous human studies have demonstrated that exposure to asbestos has increased the risk of cancer and asbestosis. Since a number of epidemiology studies indicate a positive relationship between asbestos exposure and the risk of lung cancer, several models may be used to extrapolate from risk at higher exposure to risk at lower exposure. The model that EPA believes is most consistent with the available human and animal data is the linear non-threshold dose/ response model. This model assumes that (1) any exposure increases risk, and (2) the increase in risk is proportional to the background risk in the nonexposed population and to the level of exposure, defined as duration of exposure times concentration of asbestos fibers to which populations may be exposed. The choice of the linear model is reasonable since there is no evidence for a threshold level of asbestos exposure below which there is no increased risk. It is further supported by evidence of cancers among populations whose asbestos exposure is believed to have been lower than levels reported in the epidemiology studies of asbestos workers mentioned above. The model adopted by EPA to estimate excess mesothelioma incidence due to asbestos exposure relates disease SPI-00463 3742 Federal Register / Vol. 51, No. 19 / Wednesday. January 29. 1988 / Proposed Rules incidence lo dose and the time from first exposure (minus 10 years) raised to the third power. This model reflects a delay (or minimum latency period) of 10 years between first exposure and the- likeTy earliest possible appearance of the disease. Both the lung cancer and mesothelioma models have also been adopted by OSHA (Ref. 12). The National Research Council Committee on Nonoccupational Health Risks of Asbestiform Fibers also adopted a similar linear no-threshold model to estimate risk to nonoccupational populations from exposure to asbestos (Ref. 0). The derivation and validation of the models is discussed in detail in the CHAP report (Ref. 1) and in EPA's "Regulatory Impact Analysis of Controls on Asbestos and Asbestos Products" (RIA) (Ref. 3). Although EPA believes that excess mortality from asbestosis and cancers other than lung cancer and mesothelioma will occur from exposure to asbestos released during the lifecycle of the products under study, EPA has not attempted to quantify that excess mortality. Thus, the model could understate the risk to humans from exposure to asbestos. The risk of asbestos-induced disease may be modified by several factors. As mentioned in the earlier discussion on lung cancer, smoking drastically increases the risk of developing lung cancer from exposure to asbestos. Because of their lower underlying risk, the absolute increase of incidence of lung cancer in nonsmokers is about onetenth of that in smokers. However, even complete control of the smoking factor (if possible) would leave a substantial health risk since the risk of mesothelioma (which is apparently unaffected by smoking) and the risk of lung cancer to nonsmokers would still remain. Another factor that may affect the risk of asbestos-induced disease is the possible differences in biological potency among the different fiber types. The National Research Council (Ref. 0) studied this issue and concluded: Results of studies of various groups of workers indicate that it is extremely difficult to assess the role of fiber type (e.g.. chrysolite or crocidolite) in determining the risk for developing either lung cancer or mesothelioma. Analysis of the epidemiological studies is complicated because of variations in type of industry, the diverse fiber characteristics within an industry, and the usual inadequacy of exposure data. Some scientists have interpreted the available epidemiological data to indicate that chrysolite asbestos, the asbestos type most commonly used in the United States, is less hazardous than the other types of asbestos, especially crocidolite. Such arguments have been used is the United Kingdom and other countries to tationalize different regulatory controls for trocidolite and chrysotile. However, in view < f the laboratory evidence and great i ncertainty about the nature of the fibers of i sbestos to be found in nonoccupational < xposure situations, the committee decided rot to differentiate among them in the t uantitative risk assessment. Furthermore, some of the apparent discrepancies may be explained by differences in physical [roperties of the fibers, their concentrations, end their characteristics in the different environments. These possibilities need f irther testing. In view of-this uncertainty about the relative potency of the various asbestos Upes and in view of the wellc ocumented health hazard of the most common commercial form of asbestos. I PA has concluded that it is prudent to t eat all asbestos fiber types as having equivalent biological activity. Fiber morphology has also been suggested as a factor that may affect incidence of asbestos-induced disease. Animal studies in which asbestos fibers vtere applied by injection or implantation suggest that longer and finer fibers are more carcinogenic than s lorter and coarser fibers. This has not. however, been confirmed by inhalation s:udies. EPA has not differentiated among fiber sizes in assessing the potential risk of asbestos. First, asbestos fibers released during the life cycle of asbestos products consist of a great r inge of dimensions, including those s lggested as most dangerous. Second, it has not been clearly shown that short fibers pose a significantly smaller risk, h o dimensional threshold for potency has been established. 3. Magnitude of human exposure. A sbestos fibers are released to the air during all stages of the lifecycle of aibestos products. Fiber release to the a r occurs during normal operations of n ining and milling, fiber processing into p-oducts. installation of products, p-oduct use, maintenance, renovation, d smantling, removal, and disposal. A sbestos fibers have special c laracteristics that affect exposure. They are colorless, odorless, and fiequently invisible except by n icroscope. thus presenting risk to pirsons who are not aware that they n ay be exposed. Asbestos fibers are e ctremeiy durable and have a trodynamic properties that allow them t( remain suspended in the air for a long ti me. They are basically n inbiodegradable and therefore persist ft r a very long time in the environment. Asbestos fibers easily reenter the a mosphere after settling out and can travel long distances through the air. A n port from Finland found that asbestos h id traveled as far as 27 kilometers from a mine under study. Persons can be exposed to asbestos fibers long ah those fibers have been released to tk ambient air and a considerable dit from the source of the release. Asb** fiber concentrations have been * measured in areas far from obviou* asbestos sources. Atmospheric samoli programs conducted in remote rural areas in the United States and German*'^ have found asbestos fiber levels TM between 0.01 and 0.12 nanogram/meteri(ng/m3) (1 ng is one billionth of a gram). Conversion factors between asbestos fiber counts and mass counts are variable. However. EPA estimates that 1 ng of asbestos in air equals about 30 fibers visible by light microscopy. Using this conversion factor for asbestos in outdoor air. then the above measurements are the equivalent of about 3xl0'T to 3.8xl0'* f/cc. In areas of higher human population density, measured asbestos concentrations in the air are typically much greater. A survey of large cities showed mean readings of 2.0 to 5.0 ng/ms (7.8XlO'5 tol.5xi0'4 f/ cc). Measurements taken in New'York City ranged from means of 8 to 30 ng/m1 (2.4 X10'4 to 9xl0"4 f/cc). Typical fiber concentrations are much higher in densely populated areas because of fiber release from construction work (including renovation or demolition), from asbestos-containing brakes of motor vehicles, and from other activities during the lifecycle of asbestos products. In general, levels of asbestos in the air in cities and near manufacturing plants are considerably greater than rural background levels. Thus, throughout their entire lifecycle, that is throughout their manufacture, processing, use, and disposal, asbestos products leave a legacy of asbestos in the ambient air. This ambient loath while difficult to quantify, is a significant problem. The National Academy of Sciences, after analyzing studies of outdoor air. estimated typical concentrations of asbestos in outdoor ambient air in urban areas to be approximately 0.00007 f/cc (Ref. 8). Many millions of people are exposed to those levels of asbestos in the air each day. Therefore, any comprehensive control strategy must take into account the potential for exposure during the entire lifecycle of asbestos products. Some products do not present as much potential for releases to the ambient air during certain stages of their lifecycle. For example, there are likely to be releases to the ambient air during the manufacture, processing, installation, and repair of asbestos-cement pipe. However, there generally will be no release of asbestos to the ambient air during actual use of asbestos-cement SPI-00464 Federal Register / Vol. 51. No. 19 / Wednesday. January 29, 1966 / Proposed Rules 3-13 pipe since it is commonly buried in the ground. A large proportion of the U.S. population is at risK from this asbestos in the air. Tables I through III show the numbers of persons exposed to asbestos during the more readily quantifiable stages of the lifecycle of asbestos products and the levels to which they are exposed. Exposure levels are "best estimates" based on monitoring studies. Additional information can be found in Refs. 2 and 3 which are included in the rulemaking record. To avoid disclosing confidential business information, the tables sometimes use a range rather than a single number. The notation NA means that data are not available. Table I --Exposure data for manufacturing--Occupational Asbestos product Primary manufactunrg Expo sure (1le0v*e1l / yn , Number I o* : persona ! exposed Gommerci paper...................................... | Millboard................................................. ........ Pipeline wrao................................................1 Beater-add gasket paper.... ..................... . High-grade electrical paper....................... Unsaturated rooting fett....... ..................! Saturated rooting fett................................. j Flooring tea................................. -..............1 Specialty paper......................... ................. ! v/a floor t*e................................................. | Fen-backed vinyl flooring...................... Asbestos/cement pipe............................... , Corrugated A/C sheet........ .................. _...i A/C sheet shmgta Drum brake lining.........................................! Disc brakes (LV) Disc brake* (HV)..........................................j Brake blocks ...............................................! Clutch 'acmga........................... .................. j Fnotion products--automatic trarsnus- . Sion............................................................ f Friction product*--commercial................. Cloth...............................................................1 Thread......................................................... ..j Sheet gasketing........................................... Packing ........................................................ . Surface coatings......................................... ! Sealants..................................... .................. j Plastics ... insulation ....................... ...........................! M.xed fiber ............................... ................; Other.......................... ..................................., 5 691 1 682 307 495 5.934 $40 1.313 NA 381 902 NA 561 1.016 2.778 766 1.447 1 568 1.005 1 606 1.37* 0-150 0-150 0-150 264 47 0-150 0-200 NA 82 580 NA 937 0-150 46 0-150 1 222 1.038 0-150 456 418 538 1 361 2.216 3.302 780 1.084 854 638 695 438 1 348 641 186 479 0-150 150-300 105 247 500 706 566 0-150 150-300 1.020 TABLE II.--Exposure Data for Manufacturing--Ambient Asbestos product Primary menutactunng r --1 Exposure i 1Numoer ot | level I'O* ! persons /yr) ! exposed Commercial paper .............. .......... .. , 001 68 : Millboard ........... oot 38 ! P'Oehna wrao.... .... . 001 68 | Beater-add gasket paper... ................ 00 f 66 Electrical paper ................ 001 58 . Unsaturated rooting fett..... Saturated roofing fen..... ____ . oot 86 oot 68 | Flooring felt .................. ... 1 NA * Specialty paper .. ............ 1 XI 68 | v' a Moor :i>e . . ................ 0495 : Fed backed vmyt flooring ........ 1 NA A- C pipe ....................... ...............; 307 i Fiat A.C sheet 3 07 10.000 30 000 150.000 350 OOO 10 000 200 000 60 OOO NA 10.000 660 OX NA 1.700.000 790.000 TABLE II.--Exposure Data for W Continuedanufacturing--Ambient-- Asbestos product Primary manuiactuvig Exposure Number of , <evei 1 iQ* person* I'Vti ! exposed Corrog tied A/C sneer ................... A.C si eel single .. Drum t rake inmg 0*sc banes ilv)........._ D*sc b sues ihvi Brake nocks .... Clutch lacings..................... mrS!Fnctior products--automate uans- s|on . . Fnctior products--commercial....... Cloth Threat Sheet jasketmg Packm j Surtac t costings ... Seaiar P<ast 1. msuiaittjon . .. Mixed Per Other 107 1 07 0069 0069 0069 0069 0069 ; < 70.000 310.000 720 000 320.000 NA 450.000 70.000 0069 1 069 ; 0554 . 0554 7326 7326 , 300C2 00002 ! 00002 j 1 1 NA 90 000 24 000 300 690 000 90 000 2.000 000 4 350 000 1.320.000* NA NA NA Taple HI.--Exposure Data For Installation, Use. Repair, and Disposal stos product Eioo- , 1 lseuvreel MO* f'yr) Peoee/ckeoout Numoer peroston* exposed Expo- lseuveel il.t/oO* Number of persons exposed Comm iroei paper Millbo. n PiOetini wrao........ Beater add gasket Electro paper........ .. Unsetidrated rooting 1 'eft Satura ed rooting felt ...1 Floonr j fen................... Soecia ty paper............. v;A nk or tMe.................. 1 Feit-i :ked vwty 1 ............floor "9-........................... A/C Flat A. C sheet........... , Corrugjittied A/C sheet , A/C s Drum rake lining_____ Disc: b ami e* (LV)........... Disc b ake* (HV).... ...... Brake jtocka........... _...] Clutch facing*.... ....., FoctO 1 products-- 1 aut<lofnabe tranl:ymssion......... FnctiO t product*-- com neroai . ..1 Cloth Threat .. Sheet pskeung Psckir 3... Surtac i ecoatings . Seaiar is .. O'asuc ... msuiaHi Oh... Mixed 1 Giro NA I '07 1 NA | NA | 120 1 160 1 NA | 130 ! 90 1 NA i 5.300 . 4 ?0Q , 4.700 1 4.700 | NA | NA | NA 1 NA I NA NA I 675 | NA i 380 | 12 : '20 NA ' NA > NA , NA NA | NA ! 75 j NA j I NA t ,8j 7.577 | 2.423 , NA 75 ! 5.100 , NA 27 520 8.147 756 3.095 NA NA NA NA NA I NA NA I 850 j NA ! 4.586 I 2.914 100.000 NA I NA ! NA i NA 1 NA I NA I NA I NA iI NA > NA| NA NA NA NA [ NA i NA : NA I NA , \A NA f NA i NA ! NA : na| 250 1 105 105 | na ; 250 NA NA NA NA NA 385.M9 16J '22 1 '45 NA NA | NA i 675 j NA I NA i NA ; NA | NA i NA ] 400 ; NA i NA NA 150 NA NA NA 4. Exposure from imported and expt Tted asbestos and asbestos products. EPA has determined that sign ficant exposure is likely from imported asbestos products. Although som; exposure to United States populations is avoided when asbestos prot ucts are manufactured abroad and imported rather than manufactured dorrjestically, significant exposures will still occur after their import into this country. Exposures will occur during installation and use of the product; maintenance of the product; and during dismantling, removal, and disposal of the product. Much asbestos can be released to the ambient air as a result of these activities. Large numbers of people are exposed to asbestos during these activities and the level of exposure can be quite high. Significant exposures will also occur during the domestic life cycle of bulk asbestos and asbestos products manufactured in this country for export abroad. These exposures will occur during the mining and milling of asbestos fiber and during the processing of fiber into products. There is much exposure to workers during the mining and milling of asbestos and manufacture of asbestos products. In addition, families of workers, and populations living near mining and manufacturing sites are also exposed to asbestos as a result of these activities. 5. Exposure from various categories of asbestos products. EPA has noted that various categories of asbestos products present very similar exposure patterns. For example, the products within the construction products category all present significant potential for fiber release to the air and subsequent human exposure during their installation, repair, removal, and disposal. These products are often cut. tom, sawed, and drilled during installation repair, and removal. All of these activities can release fibers to the air. In addition, sanding of these products during use often releases fibers to the air. Similarly, products within the friction products category all present significant potential for fiber release and subsequent exposure during use and repair. Friction products wear down during use. often releasing fibers to the air either during actual use of the product or during maintenance or repair operations in which previously confined asbestos-containing dust is disturbed and becomes airborne. Often, fiber releases from asbestos products in these categories occur in close proximity to other products within the same category, making it difficult to attribute observed fiber levels to a particular product. For example, EPA used monitoring data from automobile repair shops to estimate asbestos exposures resulting from repair of asbestos disc brakes, drum brakes, clutch facings, and automatic transmission friction components. Because there are no data available to estimate differences in fiber releases in the various repair activities, EPA SPI-00465 3744 Federal Register / Vol. 51 No. 19 / Wednesday, [anuary 29, 1988 / Proposed Rules developed exposure estimates for each product using a weighting scheme based on the relative production volumes of each of the friction products which are the sources of the exposure. Similarly, it is common tor many of the asbestos construction products to be used at one building site, making it difficult to attribute fiber release to one particular product. The estimation of ambient exposures due to releases from individual construction products, such as the various flooring products, was difficult since monitoring data were gathered in buildings where more than one type of asbestos flooring product was in place. For these reasons. EPA believes that it may be appropriate to consider a categorial approach to analyze the risk presented by asbestos products and to control that risk. Table IV lists the products that are included in the construction products and friction products categories. Table IV--Examples of Asbestos Product Categories Asbsttos product category Asfesstos product Consiructton product category. Friction products eatsgory. Unscturatad rooting fsft. Saturat* d roofing Ml Flooring Ion. Vinyl mbostos door 80s. Faftbacfcsd vmyi flooring, A/C pips. CorruQatsd A/C ihsot. Fist A/ C shool A/C sftsst stangts. Drum braks lining, Disc brafcs* (LV). Oise brafcss (HV* Brskd blocks, CJuWi taongs. Fnctton products--automatic iranfwa> fcon, Fncfion products com* xwo* 6. Quantitative cancer risk estimates. As discussed above, there exist many asbestos exposure-producing activities to which many kinds of populations are exposed. Applying the cancer models described above to the available data on exposure and populations, EPA has estimated the number of cancers that may be avoided by implementing the EPA's proposed regulatory program. (A full discussion of the risk estimates is contained in the "Regulatory Impact Analysis of Controls on Asbestos and Asbestos Products (Ref. 3)". Using available data and assuming current exposure levels. EPA calculates that about 2,580 lung cancers and mesotheliomas in the United States would result from production of asbestos products over 15 years without EPA action under TSCA. EPA calculates that this rule would avoid about 1.930 of those potential cancers. Assuming that OSHA achieves strict compliance with a PEL of 0.2 f/cc. EPA calculates that about 1.325 lung cancers and mesotheliomas would result unless EPA takes action under TSCA. EPA calculates that this rule would avoid aiiout 1.000 of those potential cancers. EPA also calculated the number of potential cancers avoided by the rtgulatory alternatives discussed later. Assuming current exposure levels, alternative 1. which would ban the at bestos construction products category at id asbestos clothing soon after promulgation of the rule and ban the at bestos friction products category about 5 years later, would avoid about 2. :00 cancers: alternative 2. which wsuld ban the asbestos construction products category and asbestos clothing scon after promulgation of the rule, ban th; asbestos friction products category at out 5 years later, and ban the retraining asbestos products about 10 years later, would avoid about 2,120 cancers: and alternative 3. which would ben the asbestos construction products category and asbestos clothing soon af er promulgation of the rule and cover all other asbestos products under the phase-down, would avoid about 2.020 ca rcers. LPA believes these estimates of potential number of cancers, and thi irefore the potential number of ca icers avoided, may be low for the fol lowing reasons: i. The estimate is based only on ex josures resulting from manufacture of as >estos products through the year 2000. W thout regulatory action, manufacture of asbestos products may continue be rond that date. 11. The risk estimates often do not in< lude cancers from consumer and otl er nonoccupational exposures to asl testos since data are either un tvailable or uncertain. However. EPA be ieves that many people in these ca egories are at risk. An estimated lift time risk of cancer of about 1 in 10< .000 to about 7 in 100.000 exists for an rone who merely resides in a major cit r from exposure to asbestos in the an bient air both indoors and outside of bu ldings. (Ref. 8). Any additional ex] tosure from asbestos products, such as :onsumer renovation of a house containing asbestos products, residing or working near plants that manufacture asl estos products, or residing or working in the vicinity of a construction pre ject where asbestos-containing pre ducts are being installed or removed, wi] 1 add to the risk of cancer. This additional exposure could increase the lifetime risk of cancer by more than an ore er of magnitude. c, The risk estimates did not include all workers whose occupation causes then to come in contact with asbestos products. For example, the estimates do not include occupational exposure during repair, removal, and disposal asbestos products other than friction ' products and cloth. d. EPA did not make a worst case estimate of asbestos risk. Rather. the risk estimates were based on a relatively conservative interpretation ^ the dose-response relationship for mesothelioma and lung cancer. Risk estimates more than four times as high t could be justified (Ref. 3). e. EPA did not attempt to quantify reductions of cases of asbestosis and cancers other than mesothelioma and lung cancer. These diseases may add lo to 20 percent more deaths to the total. OSHA estimates that at an exposure of 0.5 f/cc over a working career. 12 workers per 1.000 will develop asbestosis (Ref. 12). Thus, incidence of asbestosis could be significant among worker populations and possibly among other populations as well. In addition, in a major study of insulation workers exposed to asbestos, about 10 percent of all excess deaths were attributed to cancers other than lung cancer and mesothelioma (Ref. 11 j. B. Environmental Effects Section 8(c) of TSCA requires that EPA state the relevant environmental factors and key considerations which form the basis for regulatory action under section 6(a). The unreasonable risk finding of this proposal is based solely on risks to human health since these risks are by far the most serious consequence of commercial use of asbestos and are sufficient to support this proposed action. C. Benefits ofAsbestos Products and A vailability of Substitutes The benefits of the asbestoscontaining products affected by the proposed rule are discussed below. Overall, EPA finds that the benefits to society of these asbestos-containing products are small since suitable substitutes are now available for most uses and applications of asbestos, and products are being developed that will replace almost all uses and applications of asbestos during the phase-down period of this proposal. 1. Substitutes. The detailed results of EPA's analysis of the availability of suitable substitutes for asbestoscontaining products are reported in Appendix H, "Asbestos Products and Their Substitutes," of the RIA (Ref. 3) and are summarized in Table V. --' f i SPI-00466 Fri.nl / Vol. 51. flo. 19 , wri...,------------ a Table V--Summary Table of Asbestos Products, Their Major Uses, and the Extent to Which They Can be Substitut ed Asbestos product -Extent vrfvcft substitute* are avaoabte to raptaca asoeatoa products Entirely ParbaSy Asbestos c*m#n( pip* A Wong*. Ftoonng felt.......... Saturated roofing toft. Unsatteited roofing felt Vinyt/aabaatoa floor o*#. Asb**to*-te* becked vwryl snoot flooring. Adhowvoa A soatanta. Watar A sowar PP*. Backing for vmyf snoat ftoonng products. Construction o* buat-up roofing. Production ot saturatad roofing MA. Floor oia lor budding*. A general floor surlaang medium. Bmrkng surface* (adhaanr*) fittng gap* m aqtepmant A bukdmg Corrugated asbestos camont snoot Flat asbestos cement shoot Astestot camont shmgtea. AabOStOO* renforcod Friction Baatar-add gaskets. Brake Wock*.. Aaooatoa teiutoa ciotfv Clutch feong*........ Commaroai paper Comigated papar .. Oise brake pads (haavy vehtci**). Iseetenta). Stdng A roofing for biddings. Wall fining* m Owkkng*. Siding A roofing on budding*. Components ot atectncai, automo&v* A pnnbng aouemant To dtsscata heat whan gear* art changad. To promd* nonteakmg Joints. To provide protacbon agamat h*at A wear cauaad by braking m Ythrctea. Matanal at safety curtains, fire blankets. A safety dotfrng. Fncbon materials m manual transmsaion*. Ganerai nautebon papar A muHlar paper. Pipe covering A Mock mauiattofli Componanta ot brakes m haavy Disc braka pads (light A madum Drum braka lining* (light A medium vahictea). Friction material*-- industrial A commercial. Componanta ot brake* n tight A madiuni vahictea. Components ot brake* at fight A medium vehicle*. Materiel* that support braking A gear cnangmg n verve*** A industrial High grad* etectncai paper Millboard. Electrical conductor fir* aisutebon. To profart * structure aoamet haat corroaMk moisture. Tabie Pf oducts, Their' USES.^no^The eec^;^chth-c-8es~ Asbfl nos procXict Major I. E nam 10 substitute* v* avsiteote to repac* asoastoa prooucta Enorefy *1 PartMSy Asbei to* packing. To seal fluids >n spoficauons wnere motion takas piece. Protect suiace* 004 &ng*. from corrosion A watar Surface* nemo# ctumnays, tanks, Pfpakia wrap.. Ptee*. apokancas. Wfaoa tor gas. oi. hot water A steam pcmg pnmeniy underground. .! Protection agamat fciroer,rohsaioant 4 morstura <n ndustnal A office equpmam A residential terns. gaskeong.... Matanal uaed to Spec *iiffy paper* _ seal flute*-. Ftflers to punty or ctenty fiQmda; coofing tower filf; -thread, i lap. rovmg. ccfd. A w<ck. A diaohragme for eiectrorybc ceil*. Insulation lor wiring A atectncai conductors: reinforcement for plashes; insutebon for tools, packings, seals. A (ape. "he following examples illustrate the ty[ es of substitutes available for those as lestos products EPA proposes to ban, eit ter in this proposal or in one of the 3 re; ulatory alternatives described in this pr iposed rule, including the category of as jestos construction products and the ca egory of asbestos friction products. A mure complete analysis can be found in tbs Regulatory Impact Analysis (R1A) (R tf. 3). i. Friction products. Substitutes exist or are being developed for almost ail uses of asbestos in friction products. R< placement of asbestos in friction pr sducts has been more difficult than in th * other asbestos product categories b cause of the unique combination of pi ysical properties of asbestos which m ike it so well suited for friction pi oducts. e.g.. heat resistance, corrosion re listance. high tensile strength, thermal st ability, and processability. However, si bstitutes which are nearly as costeifective as asbestos products have bi ien developed for most uses of a: bestos in friction products. Asbestos automatic transmission tnc ion components are currently bema replaced w,,h cellulose-based notion components. Only one nf ih. j manufacturer, of dutch facings' them using asbestos. Clutch facing, Wh f,ber8la58 and textile fibers mto aa sigBn8ifrincalntr6epxUtecnet. aH8obwe3e(v0er,(athcemsge, substitutes are inferior to the asbestos clutch facings in durability, quietness, and tensile strength. Product development is continuing, however, to improve fiberglass facings to increase strength, wear, and ability to withstand heat through the use of special binders. Aramid-fiber-based clutch facings are also being developed. However, these have been relatively expensive compared to the asbestos and fiberglass clutch facings. Semi-metailic disc brake pads have largely replaced asbestos disc brake pads in domestic cars with front wheel drive. Currently, about 85 percent of new domestic cars have front wheel drive and are equipped with semimetallic front disc pads. Also, a nuqiber of brake manufacturers have begun to introduce an aramid fiber into production of disc brake pads. The development of substitutes for asbestos drum brake linings has not been nearly as successful as it has been for disc brakes. Manufacturers have reported problems in processing nonasbestos fibers and problems in meeting standards of durability and heat resistance. There has been limited progress to date. One automobile manufacturer has reported that its new minivans are equipped with semi- metallic drum brake linings and one brake manufacturer has begun marketing aramid fiber-based linings for the replacement brake market. In addition, one automobile manufacturer has reported progress in developing a nonasbestos drum brake lining using an aramid fiber. However, domestic car manufacturers have not begun installing aramid-based or semi-metallic-based drum brakes linings on new vehicles except in very limited applications. A number of other substitute fibers are being tested by manufacturers and may have potential as a substitute for asbestos in brakes. b. Asbestos cloth products. Asbestos cloth has been used as a final product in safety curtains, fire blankets, prctective clothing, and high-temperature c tnveyor belts. Asbestos cloth is used as i,n input product in gaskets, packing, fric ion materials, and thermal and elec rical insulation. There currently are a number of substitute fibers for asbestos use in SPI-00467 3748 Federal Register / Vol. 51. No, 19 / Wednesday, January 29, 1986 / Proposed Rules doth. These include glass fibers, ceramic fibers, carbon fibers, organic fibers, quartz fibers and cotton fibers. Replacement fibers for asbestos in cloth uses depend upon the specific application. Substitutes appear to be available for almost all high-temperature applications of asbestos cloth. If asbestos cloth were not available, EPA expects that the following substitutes would replace asbestos cloth as follows: Fiberglass cloth products: 50 to 60 percent. Aramid cloth products: 20 to 25 percent. Carbon/graphite doth products: 5 to 10 percent. Ceramics and silicon-based cloth products: 10 to 15 percent Because of their temperature and flame resistance, asbestos dothing products protect wearers from fire and heaL However, substitute products have been developed for asbestos clothing products. Araraid cloth products can substitute for asbestos in protective garments, but are more expensive. Some other textile products made without asbestos are less expensive than the counterpart product made with asbestos cloth. Substitute products for asbestos dothing include nomex, fiberglass, and zetex. Asbestos clothing has been replaced by substitutes in most or all firefighting and industrial applications. c. Asbestos-cement pipe andfittings. Products in this category are manufactured for various uses. Most pipe is used to carry water or sewage. A small amount is used to carry chemicals or is used as air ducts. Pipe varies in construction depending on use and such factors as how deep it will be buried, the rate of fluid transmitted and whether it is under pressure. EPA believes that at least one suitable substitute is available for each of the many pipe types and sizes. Based on information from, manufacturers, EPA concluded that operation and maintenance costs and service Life of all products are essentially similar. Asbestos-cement pipe does not dominate any segment of the pipe market, but is popular for certain applications such as carrying water at low pressure. If this rule is promulgated. EPA expects that the following substitutes will replace asbestos-cement pipe as follows: Polyvinyl chloride (PVC) pipe.........72 percent Ductile iron pipe.................. 23 percent Preslreeeed concrete pipe............ -4.2 percent Reinforced concreie pipe............. 0.15 percent These estimates are only approximate and do not take into account other possible substitutes that EPA considered somewiat less suitable than those noted above. These include various plastic and vifrifiei! clay pipes. All o the substitutes considered are well es ablished in the pipe market and can be oined to or replaced existing asbestc s-cement pipe sections. d. Royfing felt. Asbestos roofing felt is used fo built-up roofing, primarily on fiat roo s. "Built-up" refers to the practia of layering felt lengths on top of each ot ter with hot roofing tar or asphalt mopped between layers of adhesion and additional weather protect! jn. Currently, less than 10 percent of roofing elt sold contains asbestos. Organic felt, fibrous glass felt, and single-p y membrane roofing all have greater; hares of the fiat roof market than as! estos felt. Of the se three well-established product!. fibrous glass felt most closely approximates asbestos roofing felt in purchasi1 and installation prices and service life. Organic felt has a lower purchasu price, but has lower insulation value and moisture resistance and a somewh it shorter service life. Single-ply membra te roofing consists of a laminate of a modified bitumen or polymeric system such as polyvinyl chloride or ethylene propylene diene monomer. A typical product consists of a five-layer laminate composed of a thick plastic core prol ected on each surface by a layer of modified bitumen and an outer film of polyethylene. The purchase price of single-ply membrane roofing is several t mes that of asbestos felt, is about as expensive to install, but is expected to have a longer service life. Single-pl f membrane also has the advantaf e of not requiring the use of hot asphalt d uring installation. e. Floo -ing felt andfelt-backed vinyl sheet flot <ring. Asbestos flooring felt was used as a backing for vinyl sheet flooring [ roducts. The felt confers dimensio lal stability and helps prolong floor life vhen moisture from below the surface is a problem. EPA does not believe tf at flooring felt is currently being pro iuced in the U.S. A large number of non-asbestos vinyl flooring products have entered the market in the last 5 years. These products nclude sheet backed with felt containin j fibrous glass, cellulose, polyethyl me or polypropylene fibers, ceramic fi bers, and plastic foam. Also available are unbacked sheet and numerous traditional flooring products such as c< ramie tiles, capering, and wood floe ring. Among these many products. :onsumers will find adequate substitute i for any particular use of asbestos ( ontainmg felt or felt-backed flooring. EPA has found that price differentials between asbestos and non-asbestos vinyl sheeting are negligible. Overall, the backing is a small part of the total cost for vinyl sheet products. Maintenance and service life are not materially affected by the backing. The wide range of prices found among various vinyl flooring products are mostly attributable to the colors and patterns of the vinyl as well as the wear-layer thickness. f. Vinyl.asbestos Hoor t:le. Vinyl- asbestos floor tile is used m numerous applications, but has been especially popular for use in heavy traffic areas such as in stores, kitchens, and entry ways. Addition of fiber contributes to abrasion and indentation resistance, dimensional stability, and resistance to moisture, heat, and oil. Currently, the most suitable available substitutes for vinyl-asbestos floor tiles are various asbestos-free vinyl composition floor tiles. In place of asbestos fibers, manufacturers are using synthetic fibers including fibrous glass, * polypropylene, polyethylene, and cellulose. There are also several types of vinyl tiles that contain various fillers and resins in place of fiber. Many nonasbestos vinyl tile products have been on the market for only a few years. Consequently their service lives are not well established. Some industry contacts believe the non-asbestos tiles will last as long as the asbestos tiles, while others believe service lives will be shorter. EPA currently assumes that service lives of the non-asbestos tiles will be about one-third shorter than for the asbestos tiles. g. Asbestos-cement sheet. There are a number of cost competitive substitutes f ir asbestos-cement sheet. These nclude both products using substitute fibers and other product substitutes. Class-reinforced concrete is suitable for most corrosion and heat-resistant implications where asbestos-cement -r.eet is now used. Glass-reinforced concrete is widely available at a price fi:at has been declining relative to that of asbestos-cement sheet. Cement-wood board is suitable for the general construction applications of asbestos- cement sheet. The use of resins and surface coatings with cement-wood board makes the product suitable in ueather-resistant applications. In the siding market, asbestos-cement products have no cost advantage over galvanized steel, aluminum, or concrete. I iuwever. asbestos-cement sheet may have greater corrosion resistance than the other products. In cooling towers, polyvinyl chloride products or ceramic SPI-00468 tile products are cost competitive and a. Fibrous glass appears to be are suitable fur most applications. There consicerably less hazardous than are also a number of products that can asbestos based on (1) morbidity and substitute for asbestos-cement sheet as mortality studies in workers. (2) in vivo a laboratory desk top and fume hootf, and in vitro experimental data, (3) the bench. However, it appears that order >f magnitude lower exposure comparably priced products may not potential in the workplace. (4) the fully match the qualities of asbestos- gener. ily less respirable nature of the cement sheet in these applications. airborie fibers, and (5) the less durable h. Asbestos-cement shingles. There nature of the fibers in the lungs. are substitutes for asbestos-cement b. V ineral wood does not appear to shingles for both roofing and siding preser t the significant risks that applications. The primary substitutes for asbestos does based on (1) limited asbestos-cement roofing shingles are animai data and morbidity and asphalt-fiberglass composition shingles, morta ity studies for workers, and (2) cedar wood shingles, and various the lo1 ver exposure potential in the synthetic and natural tiles, such as Monrav roofing tile and concrete tile. workp lace. c. C tramtc fibers do not appear to Asphalt-fiberglass composition shingles preset t a comparable risk to that of cost about half as much as asbestos- asbes os based primarily on (1) the cement shingles in terms of purchase modeiate workplace concentrations, and installation costs but have only and (2) the specialized applications about half the operating life. Cedar which include its encapsulation or wood shingles have a slightly greater incorp oration into products. cost then asbestos-cement shingles but d. C arbon/graphite fibers are have a greater operating life. proba sly not a significant health risk Substitutes for asbestos-cement based on the (1) use of coatings on the shingle siding include wood, wood fibers which may reduce their shingles, aluminum siding, PVC siding, respir ability, and (2) low intrinsic stucco or concrete block, vinyl, and brick. Aluminum and PVC siding are both virtually identical to asbestos- respir ability characteristics. e. Aramid fibers appear to present relatively low risk because they are cement shingles in terms of price and durability. Cedar shingle siding is also very competitive in terms of price, but it is somewhat less durable. The total substitute market for both applications is approximately as follows: basici illy nonrespirable as currently produted and processed. f. Pi ilyethylene and polypropylene pulps and fibers appear to present relati' rely little risk since they appear t j be rel itively nontoxic and nonrespirable. g. F ttapulgite has large general Asphalt/fiberglass................................... 50perceexnptosure potential but available APBWVlruoicCmokd,sinitdpuiliremno.gd..s.u..i..cd...t.i.sn.....g...............................................................................................3.....0......-...3.....5.........p....e..r.55c..--e11n005tpppeeerrrcccaseUeeeuvd.nnnSbidttdt.siettr ice suggests that attapulgite from tines may present little hazard. In on. attapulgite is not a major tute for asbestos. 2. Possible hazards of substitutes. h. F olyvinylcholoride does not appear EPA has analyzed available data on the to pre sent a health hazard comparable health effects of major substitutes for to asbestos, although vinyl chloride, the asbestos (Ref. 14). Some of the monomer used to produce substitutes such as wood-based polyvinylchloride, is a carcinogen. The products (e.g.. cellulose fiber products) polyvinylchloride product itself presents and construction products made of brick little 'isk and workplace exposures are and concrete appear to present little appa ently adequately controlled. risk. While other substitutes present i. E uctile iron pipe does not present a some risk, EPA has concluded that the healt t hazard comparable to that of available information suggests that none asbe: tos. of the substitutes appear to present as EP \ recognizes that some asbestos great a potential for risk to human substitutes may be new chemical health as asbestos. EPA made extensive subsi ances for which a premanufacture use of the work of the National Research notic; (PMN) must be submitted under Council and agrees with their conclusion secti in 5 of TSCA. A goal of EPA's PMN that: "Current population risk from review program is to encourage the exposures to the various substances deve opment of new chemical considered, including fibrous glass, subs ances that are less hazardous than attapulgite. and carbon fibers, appears the c temical substances they replace. to be much less than for risk from EPA encourages the development of less asbestos, especially chrysotile" (Ref. 6). haza dous new chemical substances as The conclusions of EPA's analysis of asbeitos replacements. Potential specific substitutes follows. deve opers of new chemical substances intended as asbestos substitutes may wish to discuss their plans with EPA during a prenotice consultation. Such a consultation can be arranged by contacting the Prenotice Communications Coordinator by telephone at (202-382-3745) or by writing to the Fhenotice Communications Coordinator. Chemical Control Division (TS-794), Environmental Protection Agency. 401 M St., SW., Washington. DC 20460. Through a prenotice consultation, EPA can inform potential PMN submitters of legal requirements, possible EPA health concerns about the substance, and possible test data that EPA may believe necessary to evaluate the risk potential of the substance. During a prenotice consultation and any PMN review of a new chemical substance that is intended as a substitute for asbestos, EPA will consider the relative risks presented by asbestos and potentially presented by the asbestos substitute. EPA will make every reasonable effort to provide prompt and clear information concerning the likely result of PMN review in view of EPA's policy of encouraging less hazardous substitutes for asbestos. D. Economic Effects of Proposed Rule This portion of the preamble presents EPA's determination of the `reasonably ascertainable economic consequences of the rule" as required by section 6(c)(1)(D) of TSCA. EPA has prepared a "Regulatory Impact Analysis of Controls on Asbestos FToducts" (Ref. 3) which analyzes the potential economic impact of this proposed rule. The economic impact is summarized and explained below. Estimated costs are mainly from 1981 data obtained under EPA's section 8(a) asbestos reporting rule (40 CFR 763.60). Some of the data were adjusted to reflect more current information on production of asbestos products. Specifically, EPA gathered more current information on the use of asbestos clothing and asbestos flooring felt and then adjusted the estimated costs and benefits of the rule to reflect declining use of these products. The sources of the information are noted in the record for this rule. The costs are presented as the net present value of costs incurred due to changes in asbestos product production between 1985 and 2000. Costs are likely to be overstated since the baseline production levels used in the cost model probably overstate production in the future. In addition, the cost estimation model assumes that the relative prices of substitutes for I i SPI-00469 3748 Federal Register / Vol. 51, No. 19 / Wednesday, January 29, 1986 / Proposed Rules asbestos products will remain constant over the time period used for measurement of costs. Actually, price differentials are likely to decrease over time. ' . Two types of costs are estimated in the RIA: (1) Costs to consumers and (2) costs to producers. These are discussed below. The costs represent the present value of losses incurred over the 15-year period from 1985 to 2000. using a discount rate of 10 percent 1. Consumer losses due to the rule would result from increases in costs incurred for asbestos products or substitutes for asbestos products and from inferior performance of substitute products. Total consumer losses due to the rule are estimated to be $1.77 billion. However, this loss would be spread across the entire consumer population and would average less than $10 per consumer over 15 years. This rule would not cause dramatic cost increases in typical consumer products. 2. Losses would accrue to producers as a result of the rule when producers are forced to forgo some portion of the return on their capital stock used to produce asbestos products. Owners of equipment which can be readily converted to make other products are not expected to lose nearly as much as owners of equipment which cannot be easily converted. Total producer costs are estimated to be about $209 million for the rule. 3. In addition, the rule would result in transition costs to workers who are displaced by phasing down production of asbestos products. These losses are incurred in the form of lost wages and job search costs. EPA believes that transition costs of the phase-down will be relatively modest since the rule would allow industry to scale back production gradually and shift production to other products and that the transition costs from the proposed product bans will be small in comparison to the consumer and producer costs. The sum of these costs, about $1.98 billion, represents the estimated total real resource costs of the rule. This cost would be spread over 15 years. The cost will also be spread over a large population and the impact on most persons would be negligible. In addition. EPA estimated the real resource costs of the product bans proposed in this rule. These estimates are shown below: PlOOUCt *( 'WOUfC* coa* A.c P*......... ...................... ' $1654 M*OW P'OOf tit* Pioonng 1*1 . $119 5 Million No Cent Adduct i raeowca coal Asoestot aoewnj...... . _____ ; i i Milon Rooting (it_______ .... ____ , S* 2 Miikon The above costs of the rule will be offset to some extent by the following avoided costs. By reducing the amount of asbestosrelated deaths and illnesses this rule would reduce the cost to society of the health resources used to treat asbestosrelated illnesses (e g., hospital and medical treatment) and the productivity (wages and lost work capacity of sick workers, etc.) lost as a result of illness caused by asbestos exposure. EPA estimates that the avoided morbidity cost is about $1,275 per case. This is measured in 1985 dollars using a 10percent discount rate. This figure is relatively low because people generally contract mesothelioma or lung cancer after a long latency period. Thus most medical costs occur far in the future and are therefore discounted heavily. EPA did not attempt to value the loss of life itself. In addition, no value was assigned to "pain and suffering," "loss of leisure time.'" and other similar losses. Substantial asbestos removal Jnd disposal costs would be avoided is a result of this proposed rule. These include avoided expenses as weil as avoided health risks for people e \posed during removal and disposal act;. ities. Use of nonasbestos products in construction reduces demolition and disposal costs in the future. Removal and disposal costs of products are likely to be considerably higher for asbestos products than nonasbestos substitutes because of the extra precautions required to meet OSHA and Clean Air Act (CAA) requirements. Avoided removal and disposal costs are a major oenefit of this proposed regulation. These costs can be substantial. EPA has estimated that removing asbestos from ichool buildings costs between $2 and 513 per square foot of asbestos removed. OSHA and EPA both have regulations o limit asbestos exposure at work sites. Certain costs related to compliance with hese regulations would be avoided as a esult of this rule. To comply with DSHA's current workplace standard for isbestos. employers incur expenses elated to: a. Monitoring for fibers. b. Providing engineering methods to control exposures (this includes i nclosing or isolating asbestos fiber j enerating activities, providing exhaust ' entilation. dust collection, etc.) c. Providing hand tools such aj scorers, drills, and abrasive wheels tWa have local exhaust ventilation ytcm ** d. Modifying work practices to -- rtu.jB exposure. e. Providing special clothing, change J rooms, lockers, and special laundering. -J f. Labeling asbestos material and posting caution signs. fj 9 g. Providing special procedures for 3 collection and processing of asbestos I waste. i h. Providing medical examinations for employees exposed to asbestos. i. Responding to recordkeeping and reporting requirements. EPA's CAA regulations require that activities during milling, manufacture, demolition and renovation, waste disposal, and some other asbestos- related activities release "no visible emissions." To comply with this requirement, persons must obtain and maintain air-cleaning devices such as filters and may be required to modify work and waste disposal practices to reduce emissions. In addition, both OSHA and EPA may require stricter workplace controls for asbestos in the near future. The costs of complying with those requirements would be avoided at least in part by this rule. United States courts and workman's compensation boards have been inundated with thousands of claims for compensation for deaths and illnesses caused by exposure to asbestos. Some past producers of asbestos products have declared bankruptcy because of these many claims. The continued use of asbestos can only exacerbate the problem. Each case of disease avoided relieves the "various systems affected of a considerable burden. This rule, by reducting exposure to asbestos and reducing the number of asbestos-related illnesses and deaths, would reduce these costs. As required by section 8(c)(1)(D) of TSCA. EPA has analyzed the economic impact of this proposed rule on small businesses. The effect of this rule on such businesses is expected to be small because (1) there are few small businesses producing asbestos products and (2) producer losses are expected to be small since capital equipment for production of most asbestos products can be converted fairly easily to other forms of production. A maximum of 27 out of the 212 primary processors of asbestos products are small businesses. EPA acknowledges that these 27 companies could incur losses under the rule. EPA was unable to determine how many of the secondary processors of asbestos products are small businesses. SPI-00470 Federal Register / Vol. 51. No. 19 / Wednesday. January 29. 1986 / Proposed Rules 3749 However. EPA acknowledges that a higher percentage of secondary processors are likely to be small businesses than the percentage of primary processors that are small businesses. Li addition. 5 ofihe 11 companies that manufacture the products that this rule proposes to ban are small businesses. This proposed rule could have significant impact on these few companies. The estimated costs of the rule could be seen as significant. However, the overall benefits to society of asbestoscontaining products are diminishing with the current availability and the continued development of various nonasbestos substitutes. The costs of the rule are speculative and probably are overestimated. In addition, many economic impacts of this rule are likely to be short-term and spread across large populations with only negligible impact on the typical consumer. This rule is not expected to cause dramatic price increases in typical consumer products. Consumer losses caused by this rule would be spread across the entire consumer population, fobs displaced by this rule are likely to be offset by increased employment in companies producing substitutes for asbestos products. Potential consumer and producer costs are likely to be offset by the economic costs avoided by this rule, i.e.. avoidance of the morbidity costs of asbestos-related diseases; the cost of removal and disposal of asbestos products; the costs of special control to reduce exposure to asbesto: and costs associated with legal actions seeking compensation for asbestos-related illnesses and deaths. Finally, the estimated costs of this rule appear reasonable in view of the unreasonably large number of asbestos-related deaths and serious illnesses that would occur without a phase-out of asbestos. EPA expects that this proposed rule would have a positive impact on technological innovation and encourage the continued rapid development of nonasbestos substitute products. This development of new products is likely to involve significant technological innovation. IV. Other Options Considered Section 6 of TSCA requires that EPA apply the least burdensome requirements to reduce an unreasonable risk. EPA is considering a number of options for implementing the regulatory policy of phasing out the manufacture and importation of asbestos products. These options involve staged bans of categories of asbestos products. This approach would ban the manufacture, importation, and processing of all asbestos products within a certain ca egory at the same time. EPA is co isidenng a category approach for groups of asbestos products with similar ex josure patterns, similar exposure co itrol issues, and similar substitutes. Examples of categories under co isideration are construction products and friction products. EPA believes it mt y be good public policy to ban ca egories of products at the same time. This approach would address similar ex josure patterns in the same way and treat all parts of an industry sector similarly. In addition, both the co istruction products category and the fri :tion products category contain products that could substitute for other products in the category if all are not banned. Thus, a ban of the entire ca egory may be necessary to reduce ris k most effectively. Dne option under active consideration in addition to the ones embodied in the pr iposal is banning the manufacture, importation, and processing of the as jestos construction products category and asbestos clothing with the ban eflective soon after promulgation of the ru e; banning the manufacture, importation, and processing of the as jestos friction products category about 5 years after promulgation of the ru e; and gathering up-to-date pr iduction. exposure, and use data n thu remaining asbestos products under se :tion 8(a) of TSCA to support posable bans of other asbestos products at ; it tine. Another option is banning the manufacture, importation, and pr )ce9sing of the asbestos construction pr xiucts category, asbestos clothing, ar d the asbestos friction products category as stated above and banning th i remaining asbestos products at a la er time (e.g.. 10 years), thus allowing tir le for the development of effective substitutes while strongly encouraging substitute development. A third option is banning the manufacture, importation, ard processing of the asbestos construction products category and asbestos clothing as stated above and covering ail other asbestos products ur der the phase-down. Under each of th; options. EPA is also considering a re luirement that products not banned soon after promulgation be labeled as cc ntaining asbestos. EPA is actively considering these o[ tions as alternatives to this proposed rule and specifically requests comment or these alternatives. EPA may adopt a fii.al rule based closely on one or a cc mbination of these alternatives. These alernatives are discussed more fully be low. t. Ban the asbestos construction products category and asbestos clothing soon Q, ter promulgation of the rule, ban the asbestos friction produce category about 5 years later, and gather additional information on other asbestos products. Under this alternative. EPA would ban the manufacture, importation, and processing of the asbestos construction products category (i.e.. asbestos-cement pipe and fittings, roofing felts, flooring feits and felt-backed sheet flooring, vinyl-asbestos floor tile, corrugated asbestos-cement sheet, flat asbestoscement sheet, and asbestos-cement shingles] and asbestos doming soon after promulgation of the rule. Effective substitutes exist for these products. The rule would also ban the manufacture, importation, and processing of the asbestos friction products category (i.e.. drum brake linings, disc brake pads for light, medium, and heavy vehicles, brake blocks, clutch facings, automatic transmission friction components, and industrial and commercial friction materials) 5 years after promulgation of the rule. This alternative would reduce exposure to asbestos without the administrative burden of EPA establishing and operating a permit system as in the proposed approach. This alternative, by banning asbestos friction products 5 years after promulgation, would strongly encourage the rapid development of additional effective substitutes for asbestos friction products. The 5-year delayed ban would also allow time for expansion of production capacity for non-asbestos friction products. EPA estimates that this alternative, assuming current exposure levels, would avoid about 2.100 cancer cases that EPA can quantify while costing about $2.11 billion. This is a cost of about 1.01 million per cancer case avoided. Because OSHA has proposed lowering the workplace PEL for asbestos to 0.2 f/cc. EPA also estimated the numbers of cancer cases avoided assuming strict compliance with this lower PEL. Assuming strict compliance with an OSHA PEL of 0.2 f/cc. EPA estimates thtjt this alternative would avoid about 1.060 cancer cases that EPA can quantify, while costing about S2.ll billion. This is a cost of about S2.00 million per cancer case avoided. To determine how sensitive the cost per cancer case avoided was to the banning of particular products. ETA conducted a sensitivity analysis, excluding asbestos-cement pipe from the ban. Without a ban of asbestos-cement pipe and assuming strict compliance SPI-00471 3750 Federal Register / Vol. 51, o. 19 / Wednesday. January 29, 1986 / Proposed Rules with an OSHA PEL of 0.2 f/cc. EPA estimates that this alternative would avoid about 840 cancer cases that EPA can quantify, while costing about $1.87 billion. This is a cost of about $2.22 million per career case avoided. EPA believes that effective substitutes are increasingly becoming available for asbestos friction products and will be readily available by the date the delayed ban would become effective. However. EPA is considering an exemption process for essential uses without substitutes. One area EPA is studying in particular is the aftermarket for asbestos brakes. Some persons have stated that asbestos brakes now in use cannot safely be replaced by asbestosfree brakes when they wear out. while others have disagreed with this assertion. EPA is aware of the potential risk to the public from poorly performing brakes. EPA specifically requests comment on this issue. EPA considered various approaches for addressing the risk presented by asbestos products not banned either soon after promulgation or 5 years after promulgation under this alternative. One approach would be to propose and promulgate a rule under section 8(a) of TSCA to gather contemporaneous data concerning the production and use of and exposure to these products at the time the first products ban rule becomes effective or at a date a few years later. EPA would analyze that data and then decide whether to ban additional asbestos products. EPA would also determine the date of these bans, which may be at staged intervals. After deciding these issues, EPA would propose and promulgate the bans of these asbestos products. Another approach for addressing the risk presented by these remaining asbestos products is discussed as alternative 2 below. 2. Bon the asbestos construction products category and asbestos clothing soon after promulgation of the rule, ban the asbestos friction products category about 5 years later, and ban remaining asbestos products about 10 years later. Under this alternative, as in alternative 1. EPA would ban the manufacture, importation, and processing of the asbestos construction products category and asbestos clothing soon after promulgation of the rule, and ban the manufacture, importation, and processing of the asbestos friction products category 5 years after promulgation of the rule. This alternative would also ban the manufacture, importation, and processing of all other asbestos products 10 years after promulgation of the rule. This alternative would relatively quickly ban , i number of asbestos products for whici effective substitutes exist while 3trongly encouraging the rapid cfeve opment of effective substitutes for other asbestos products. Th s alternative, unlike alternative 1, avoir s the necessity of future rulen akings to gather additional data and t ien ban additional products. It woul 1 also provide greater certainty aboui the status of all asbestos products and n ore strongly encourage the devel ipment of substitutes for all applii ations of all products. As n alternative 1. EPA is considering the nr ed for an exemption process for asbes:os friction products in connection with tie staged product bans. EPA estimates that this alternative, assun ing current exposure levels, would avoid about 2.120 cancer cases that EPA can qi antify while costing about $2.29 billior. This is a cost of about $1.08 miilioi i per cancer case avoided. Ass iming strict compliance with an OSHA PEL of 0.2 f/cc. EPA estimates that this alternative would avoid about 1,070 c ancer cases that EPA can quanti y, while costing about $2.29 billion This is a cost of about $2.13 millior per cancer case avoided. Wit) out a ban of asbestos-cement pipe at ,d assuming strict compliance with ai i OSHA PEL of 0.2 f/cc. EPA estima es that this alternative would avoid t bout 950 cancer cases that EPA can qu intify, while costing about $2.02 billion. This is a cost of about $2.12 million per cancer case avoided. 3. -Ba a the asbestos construction produc s category and asbestos clothing soon aj ter promulgation of the rule and cover a II other asbestos products under the phase-down. Under this alternative EPA would ban the manufacture, importc tion. and processing of the asbestc s construction products category and as! estos clothing soon after the promul| ation of the rule and cover all other ai bestos products under the phase-c own. This Alternative, unlike the current proposal . would ban all asbestoscement products at the same time, thus address ng similar exposure patterns in the sam;i way and treating all parts of an indui try sector similarly. The phasedown wruld operate to restrict use of i in other industry sectors. EPA eistimates that this alternative, assuming current exposure levels, would avoid at out 2.020 cancer cases that EPA antify while costing about $2.01 billion." 'his is a cost of about $1.00 million f er cancer case avoided. Assun ing strict compliance with an OSHA P;L of 0.2 f/cc. EPA estimates that this alternative would avoid ahnnt 1.010 cancer cases that EPA can quantify while costing about $2.01 billion. This is a cost of about $1.98 million per cancer case avoided. Without a ban of asbestos-cement pipe and assuming strict compliance with an OSHA PEL of 0.2 f/cc. EPA estimates that this alternative would avoid about 950 cancer cases that EPA can quantify while costing about $1.88 billion. This is a cost of about $1.95 million per cancer case avoided. The following Table VI summarizes the estimated costs and estimated cancer cases avoided that EPA could quantify for the proposal and the three alternatives discussed earlier, first assuming current exposure levels and then assuming strict compliance with an OSHA PEL of 0.2 f/cc. Table VI--Estimated Costs and Cancer Cases Avoided i Pro bosaf Art ah a ! ah 3 Assuming Current Exposures Cost (billions)........ -........... ; Si 96 Cancer cases avoided....... ; 1930 Cost per cancer case i avoided (mdfcona)............. | SI 02 52 11 2.100 *1.01 $2 29 2J20 SI 06 $2.01 2.020 St oo Assuming Slncl Compliance With an OS^A PEL of 0 21/cc Cost [brtkone)........................ j St 90 Cancer cases avorted........ 1 1.000 Cost per cancer case avoided (mrtions)............. 1 SI 99 S2 11 S2.29 S2.01 1.060 1.070 1.010 $2.00 $2.13 SI M _________ Attemauve i--Ban asbestos construction products and asoestos coming soon after promulgation and ban asbestos friction products n five years. Alternative 2--Ban asbestos construction products and asoestos dotting soon an* promwganon. ban asbestos 'ncuon products in five years and ban remaining prodtfts m ten years Alterative 3--Ban asbestos construction products and asbestos ctotrtmg soon after promulgation and cover remenv mg orooucts under the pnase-oown 4. Require labeling of asbestos products subject to a ban. As part of this alternative, EPA also proposes and requests comment on a labeling reguirement. In particular, it is proposed that products not immediately banned but subject to regulation 5 or 10 years from now be labeled in the interim. The labeling would advise purchasers that the product contains asbestos. EPA requests comments on this proposal, in particular on (1) the appropriateness of this proposal for all or some subset of the products in this category: (2) the appropriateness of a simple content warning as opposed to a more extensive labeling provision: and (3) the extent to which labeling would serve to reduce exposure to asbestos. EPA also considered a number of alternatives for implementing the phasedown. These include options concerning the following: who would be assigned permits: how persons would be granted i. x * F 4 k SPI-00472 Federal Register / Vol. 51. No 19 / Wednesday. January 29. 1986 / Proposed Rules 3751 permits; whether permits would be transferable: whether permits would be bankable: and how imported products containing asbestos would be treated. EPA also considered a number of options before adopting its current regulatory strategy for controlling the risk from asbestos. These options are discussed in documents which are included in the rulemaking record. V. Finding of Unreasonable Risk EPA has weighed the health risks from continued use of asbestos and asbestos-containing products against the costs attributable to the proposed regulation. EPA has concluded, that the avoidance of about 1.930 cancer cases that can be quantified assuming current exposure levels, or the 1,000 cancer cases that can be quantified assuming strict compliance with an OSHA PEL of 0.2 f/cc, many other cancer cases that cannot be quantified, and many cases of asbestos-related disease substantially outweigh the costs to consumers, producers, and users of asbestos products from the proposed regulation. Therefore. EPA finds that the continued mining and importation of asbestos and asbestos products in the United States for domestic use and for export present an unreasonable risk to human health. The finding is based on the following points: 1. The health effects from asbestos exposure are very serious. Asbestos is a demonstrated human carcinogen. The cancers caused by asbestos are usually fatal and cause much pain and suffering. In addition, asbestos causes other lung diseases such as asbestosis. 2. Available evidence supports the conclusion that there is no safe level of exposure to asbestos. This conclusion is consistent with present theory of cancer etiology and is further supported by the many documented cases where low or short-term exposure has been shown to cause asbestos-related disease. 3. Models developed to estimate the relative risk of developing cancer from exposure to asbestos show a linear dose-response relationship. Based on data from epidemiology studies, these models predict that humans exposed to very low levels of asbestos incur some risk. Individuals frequently exposed to levels typically found at asbestos worksites are estimated to have very high risks of contracting cancer, perhaps greater than 1 in 1Q0. 4. Asbestos fibers are colorless, odorless, and frequently invisible, thus presenting risk to persons not aware that they may be exposed. Asbestos fibers are extremely durable and have aerodynamic properties that allow them to remain suspended in the air for a long time / sbestos fibers easily reenter the atmo;sj here after settling out and can travel ong distances through the air. 5. Hu alth risks from exposure to asbestfcr,s fibers during the lifecycle of the a sllestos products covered by this propoii ed rule occur to many population groups during many activities. Persons can be exposed to asbestos fibers long after tjiose fibers have been released to the air and at a considerable distance from tl le :source of release. The vast majo rity of the general population of the U.S.is exposed to asbestos in the air. More tjhan 40.000 workers are exposed during manufacture and processing of asbestp:s products covered by this propo lal. Many additional thousands of worke s and consumers are exposed during product installation, use. mainti nance, renovation, removal, and dispo:sal of asbestos products. Finally, many nillions of people who reside near asbesfos worksites are also exposed to signifi ant concentrations of asbestos in the ail 8 .Ui ing typical, rather than worstcase, data and assumptions. EPA has estim: ted that this proposed rule banni: ig certain asbestos products and phasii g out all others, if promulgated, would avoid approximately 1.930 cases of can|cer which would otherwise result from Exposure to asbestos between the years 1985 to 2000. EPA underestimated the mlumber of cancer cases avoided because of the lack of comprehensive data releases of asbestos to the ambie nt air from many activities. EPA estimi ities that the following numbers of cancer cases would be avoided as a result of the proposed product bans, assuni:ing both current exposure levels and s rict ci ompliance with an OSHA PELo r0l.2t f/cc. Asbesio i aotfrng. AP''oCo:pr *tjk. Flooring felt Booting m Career cases avoioed Current .. , . e*oo* , ,,.V sure ' >< 533 459 0 Thi se estimates of cancer cases avoi c ed by the product bans should not be vi twed in isolation, since asbestos use! 11 other product sectors would theorfeideally decrease at less than the curre it rate unless all asbestos use is phasii d out. 7. en if OSHA promulgates and achie|vres strict compliance with a PEL of 0.2If/:c. almost 1.325 cancers would still resul from asbestos products made over the next 15 years. This rule would avoid about 1.000 of those cancer cases. 8. The estimated costs of this proposed rule are reasonable in view of the number of cancers and other adverse health effects that would be avoided. Substitutes for asbestos are readily available for many products and can be expected to become available during the phase-down period for most, if not all. other uses. Even though the costs are probably overestimated, the cost per cancer case avoided, assuming current exposure levels, that EPA can quantify, is about $1.02 million. Even if OSHA promulgates and achieves strict compliance with a PEL of 0.2 f/cc. the cost per cancer case avoided that EPA can quantify is about $1.99 million. If all cancer cases and the incidence of other diseases could be quantified, the cost per case of disease prevented would be substantially lower. In addition, the overall costs of the rule are spread over a large population so that the cost to any individual would be negligible. Further. EPA expects substantial savings to result from this rule from such factors as avoided costs in treating asbestos related diseases, avoidance of lost productivity caused by these diseases, avoided costs in asbestos removal and disposal, and avoidance of litigation costs resulting from asbestos disease claims. EPA also finds that the costs of alternatives 1. 2. and 3 are reasonable in view of the numbers of cancers and other adverse health effects that they would avoid. The costs per cancer case avoided that EPA can quantify of these alternatives are approximately the same as for the proposed rule. As discussed earlier, EPA conducted a sensitivity analysis to see how sensitive the cost per cancer case avoided by this rule and the cost per cancer avoided by the regulatory alternatives discussed earlier were to the banning of particular products. Specifically. EPA analyzed the cost per cancer case avoided for the proposal and the other options excluding asbestos-cement pipe or vinly-asbestos floor tile from the bans, Even with these relatively high exposure products excluded from the bans, the cost per cancer case avoided by the proposal and the alternatives are similar. For example, without a ban of asbestos-cement pipe and assuming strict compliance with an OSHA PEL of 0.2 f/cc. this proposed rule would cost about SI.96 million per cancer case avoided that EPA can quantify. Without a ban of vinyl-asbestos floor tile and assuming strict compliance with an OSHA PEL of 0 2 f/cc. this proposed rule SPI-00473 3752 Federal Register / Vol. 3l, No. 19 / Wednesday, January 29, 1986 / Proposed Rules would cost about $2.28 million per cancer case avoided that EPA can quantify. VI. Other EPA Statutes Section 8(c) of TSCA requires that if EPA determines that a risk of injury to health or the environment could be eliminated ur reduced to a sufficient extent by actions taken under another statute administered by EPA. EPA may not promulgate a rule under section 8(a) of TSCA unless EPA finds it is in the public interest to protect against the risk by action under TSCA. EPA finds that no other law administered by EPA will eliminate or reduce the risks from asbestos to a sufficient extent. Several EPA statutes have been used to limit asbestos exposure. In 1973. EPA used the authority of the CAA to list asbestos as a hazardous air pollutant establish a "no visible" emission standard for manufacturers, and ban the use of spray-applied asbestoscontaining material as insulation in buildings, published in the Federal Register of April 6,1973 (38 FR 8826). EPA amended this regulation in 1975 to ban asbestos-containing pipe lagging, by a rule published in the Federal Register of October 12,1975 (40 FR 46292); and in 1978, extended the ban to all uses of sprayed-on asbestos by a rule published in the Federal Register of June 19,1978 (43 FR 26372). The CAA rule, which was last amended on April 5,1984 (49 FR 13658), also regulates the removal of asbestos from buildings and the disposal of wastes generated by removal. However, the CAA has limitations. The CAA does not apply directly to indoor air in the workplace or home. Consequently, any possible additional use of that statute may leave many workplace or home exposure situations inadequately controlled. Another EPA statute that could be used to limit asbestos exposure is the Safe Drinking Water Act (SDWA). EPA announced its intention to consider asbestos for inclusion in its proposed National Revised Primary Drinking Water Regulations by a Notice published in the Federal Register of October 5, 1983 (48 FR 45502). However, even if the SDWA is used to set a drinking water standard for asbestos, it would necessarily ignore the inhalation risk associated with asbestos. An additional EPA statute that could be used to limit asbestos exposure is the Resource Conservation and Recovery Act (RCRA). Under RCRA, EPA could list asbestos as a hazardous waste and subject asbestos waste to general RCRA requirements designed to reduce exposure. However, such.action under RCRA would only reduce exposure luring the disposal of asbestos and isbestos products. /II. Analysis Under Section 9(a) of TSCA Under section 9(a)(1) of TSCA. the \dministrator is required to submit a eport to another Federal agency when wo determinations are made. The first letermination is that the Administrator lias reasonable basis to conclude that a nhemical substance or mixture presents or will present an unreasonable risk of i njury to health or the environment. The i econd determination is that the unreasonable risk may be prevented or educed to a sufficient extent by action taken by another Federal agency under Federal law not administered by EPA. Section 9(a)(1) provides that where the i idministrator makes these two t eterminations. EPA must provide an c pportunity to the other Federal agency t j assess the risk described in the r sport, to interpret its own statutory c uthorities. and to initiate an action 1 nder the Federal laws that it dministers. Section 9(a) of TSCA thus requires EPA to review other Federal uthorities not administered by EPA to c etermine whether action under those a uthorities may prevent or sufficiently r iduce unreasonable risk. The following u nit summarizes past and contemplated action by other agencies and then d iscusses why those agencies are not a ble to prevent or sufficiently reduce the unreasonable risk presented by ajbestos. /. Other Authorities Affecting Asbestos Under the authority of the Consumer Product Safety Act (CPSA, 15 U.S.C. 2 J5T) the CPSC has issued rules banning c msumer patching compounds c mtaining respirable asbestos (16 CFR Part 1304) and artificial emberizing n aterials containing respirable asbestos (16 CFR Part 1305). The CPSC took those a :tions based on findings that the use of those products in the household would ri suit in increased risk of cancer. E trlier, the Food and Drug Administration under the Federal H azardous Substances Act (FHSA, 15 U.S.C. 1261) banned "general-use g; irments containing asbestos other than g; irments having a bona fide application fc r personal protection against thermal ir jury and so constructed that the a: bestos fibers will not become airborne ui ider reasonably foreseeable conditions o: use" (16 CFR 1500.17). The FHSA is n< iw administered by the CPSC. In 1980. CPSC issued a general order re quiring persons to furnish information oi i the use of asbestos in certain c< nsumer product categories. CPSC has aho measured potential consumer exposure to asbestos from such products as asbestos millboard, asbestos paper products, and stove door gaskets. OSHA began to regulate asbestos in the workplace in 1971 under the Occupational Safety and Health Act (29 U.S.C. 51. OSHAct). Since the first workplace standard setting a limit of 12 f/cc was promulgated in May 1971, the workplace standard has been twice revised and is now 2 f/cc (TWA). An Emergency Temporary Standard (ETS) establishing a permissible level of 0.5 f/cc was published in the Federal Register of November 4,1983 (48 FR 51088), but the ETS was found invalid by a court. OSHA proposed a revised standard in the Federal Register of April 10,1984 (49 FR 14118). The Mine Safety and Health Administration (MSHA) acting under the Mine Safety and Health Act has adopted workplace standards designed to protect workers engaged in pit and underground mining and milling. The MSHA standards are similar to those administered by OSHA for other, workplaces. The MSHA standard was last amended in 1976 and calls for a PEL of 2 f/cc. Possible jurisdiction over other aspects of asbestos risk may lie with still other Federal agencies. For example, the AsbestoB Information Association (AIA), commenting before a Senate subcommittee on early versions of TSCA. noted that the Federal Trade Commission may have authority to require labeling, distribution, and marketing of asbestos products and that the Department of Transportation has authority to control transportation of hazardous substances, such as asbestos. 1971 Senate Hearings at 224-227. State and local public employees are generally excluded from coverage under the OSHAct. However, under section 19 of the OSHAct. OSHA has approved State plans for 23 States and two territories, thus effectively extending OSHA protections to State and local public employees in the jurisdictions. EPA has proposed a rule to establish requirements similar to those of the OSHA Asbestos Standard for State and local public employees not under a State plan who conduct asbestos abatement work. However, other public employees, such as firefighters, are not covered by this rule. B. EPA's Determination Under Section 9(a) of TSCA EPA is not required to submit a report to other agencies under section 9(a) on the asbestos risks described in this notice since EPA has determined that such risks cannot be prevented or SPI-00474 Federal Register / Vol. 51, Vo. 19 / Wednesday, January 29, 1986 / Proposed Rules 3753 reduced to a sufficient extent by actions taken under a Federal law not administered by EPA. Certain activities involving asbestos present risks that fall under the jurisdiction of a number of., different Federal laws such as the OSHAct, the Consumer Product Safety Act, and the Clean Air Act, but no one statute, other than TSCA. can adequately address all its risks. Referral would result in fragmented assessment of risks and potentially duplicative regulatory efforts, inefficient control of risk, and an adverse effect on public health. Furthermore, even if EPA were to refer asbestos risks to other agencies, action taken by those other agencies would still leave a substantial residual risk. EPA's reasons for reaching this conclusion are set forth below. 1. Interpretation of section 9(a) of TSCA. The comprehensive nature of TSCA has long been recognized. TSCA allows regulation of a chemical substance based on all its risks and, thereby, allows the Government to remedy the deficiencies in other statutes that can deal only with parts of the risk. (Statement of the President on signing S. 3149 Into Law, October 12,1976, Weekly Compilation of Presidential Documents, vol. 12, No. 42, Oct. 18.1978, at 1489: S. Rep. No. 94-698, 94th Cong., 2d Sess. at 2.) The need for a total exposure approach to chemical regulation and the dangers of a fragmented regulatory approach were recognized even during the early congressional hearings on TSCA. See, e.g. 1973 Senate Hearings at 212-214:1972 House Hearings at 85-67. No other single law provides authority to deal comprehensively with multimedia hazards. In particular. Congress designed TSCA to deal with chemical substances for which the most appropriate remedy would be a total ban on their production and distribution in commerce. In this regard, Congress focused on the risk of asbestos and the dangers of fragmented regulation of asbestos during the legislative hearings. See 1971 Senate Hearings and 1973 Hearings. Asbestos risks were described in the workplace and in over 3.000 uses that could present risks to the general population. (H.R. Rep. No. 94-1341, 94th Cong., 2d Sess.. at 5 (1976).) Members of Congress believed it intolerable that no agency could deal comprehensively with chemical risks, including the risk from asbestos. See 1973 Senate Hearings at 319-320 (Letter from Senator Tunney to Dow Chemical Company); 1975 Senate Hearings at 131- 133 (Remarks of Senator Tunney). EPA's decision not to refer the risks associated with asbestos is divided into two parts. First, EPA determines that the e is no other Federal authority capable of addressing the combination of e divides involving asbestos. Section 9(a requires EPA to consider the issues necessary to make this determination because the Agency believes that the combination of asbestos activities, unc er the jurisdiction of a number of Fee eral laws, presents an unreasonable risk. Second. EPA examines the residual risk s that would remain if other agencies we: e to regulate asbestos and det trmines that such residual risks wo lid still be unreasonable. 2 Capability of other Federal aut iorities to deal with the combination ofesbestos activities. EPA has concluded that asbestos is a clear exa mple for TSCA action rather than reft rral to other agencies. It is a substance for which there is broad exp osure to populations in numerous situ ations--in the workplace, through am )ient concentrations, and from cor sumer products. With the exception of' 'SCA, there is no one unified aut lority to deal with these multiple exp osures. No one of the other potential Fee eral regulatory authorities, in looking at i s specific part of the overall exp osures. can either evaluate or deal wit l the totality of the risk presented. Thi s, OSHA may set exposure limits for wo kers. but there may be venting of asb estos into the atmosphere; EPA. unc er the Clean Air Act, may regulate am )ient emissions, but not workplace or cor sumer exposures: and in each step of the process, only a fraction of the risk is eva luated. Only EPA under TSCA may loo c across the range of asbestos use to eve luate whether it presents an unreasonable risk. There is no other Act that affords such authority and, acc ordingly, referral is inappropriate. E PA's analysis of the jurisdiction over the risks presented by asbestos among a nui iber of agencies and statutory aut iorities is set out below. OSHA has aut lority under the OSHAct for risk presented to private sector ma lufacturing, construction, and service em rloyees from workplace exposures, and may approve State plans covering State and local public employees. CPSC hai authority under the CPSA and FH 5A concerning risk presented to cor sumers from consumer products. The Mi le Safety and Health Administration hai authority under the Mine Safety and He slth Act concerning risk presented dui ing the mining and milling of asbestos. State and local public employees, such as firefighters who may wear asbestos clothing, in about half the StE tes are not covered even indirectly by OSHA regulations and are subject to StE te authority. 3. Residual risks. Even if other Federal agencies took additional action to reduce the risk associated with asbestos during the various stages of the lifecycle of asbestos products clearly within their jurisdiction, a substantial and unreasonable residual risk would still remain. Many groups outside of OSHA jurisdiction are at risk from exposure to asbestos. State and local public employees, such as firefighters, are not protected by OSHA regulations in about half the States. The general population is exposed to asbestos in the ambient air as a result of release during the manufacture, processing, use, repair, and disposal of asbestos products. EPA estimates that about 540 persons will develop cancer as a result of exposure to asbestos in the ambient air as a result of releases associated with products imported or manufactured over the next 15 years. Even if OSHA promulgates and achieves strict compliance with a PEL of 0.2 f/cc, a substantial and unreasonable residual risk would remain. About 1,325 persons would still develop cancer as a result of exposure to asbestos in products imported or manufactured over the next 15 years. These include cancers in populations totally outside of OSHA's jurisdiction. Even with a lower workplace PEL, EPA estimates that about 540 persons will develop cancer from exposure to asbestos in the ambient air. In addition, at a PEL of 0.2 f/cc, EPA estimates that about 785 workers under OSHA jurisdiction would develop cancer as a result of workplace exposure to asbestos in products imported or manufactured in the next 15 years. EPA calculated these figures using well-accepted models. EPA used the Nicholson relative risk model to estimate the number of lung cancer cases and the Nicholson absolute risk model to estimate the number of mesothelioma cases. The dose-response constants used in the risk assessment were those estimated by Selikoff in a study of asbestos insulation workers (Ref. 11). A number of epidemiological studies have estimated dose-response constants for asbestos-related diseases and estimates vary by as much as an order of magnitude. The Selikoff estimates fall approximately in the middle of the ranges of dose-response estimates for both lung cancer and mesothelioma. In addition, the Selikoff estimates have the lowest variance among all of the estimates. These models and dose response constants were recommended by the CPSC's Chronic Hazard Advisory Panel on SPI-00475 3754 Federal Register / Vol. 51, No. 19 / Wednesday, January 29, 1986 / Proposed Rules asbestos (Ref. 1) and were also used by OSHA to estimate the risk posed by asbestos in support of the proposed revision of OSHA's asbestos standard. OSHA's choice of 0.2 f/cc as a proposed PEL was based on the feasibility of measuring asbestos levels in the workplace. At a level of 0.2 f/cc, OSHA. using the same lung cancer and mesothelioma models as EPA, estimates that there would be 870 excess cancer deaths per 100.000 workers exposed over a working career (Ref. 12). In 1980, a joint NIOSH/OSHA Asbestos Work Group stated that there was no level of exposure to asbestos below which clinical effects did not occur and recommended a PEL of 0.1 f/cc based on the limitation of current technologies for measuring air concentrations of asbestos (Ref. 7). Even a level of 0.1 f/cc. OSHA estimates that there could be 336 excess cancer deaths per 100.000 workers exposed over a working career (Ref. 12). It is likely that a PEL of 0.2 f/cc will be exceeded in many cases since it is particularly difficult to apply the PEL in the construction and service sectors. Many of the workplace exposures to asbestos occur downstream in the construction and service sectors rather than the manufacturing sector. Over 80 percent of workers exposed to asbestos are in the construction and service sectors. Employees in those sectors often do not know when they are exposed to asbestos because they do not know that they are working with asbestos products. Compliance inspections are also difficult in the construction and service sectors since employees frequently do not have a fixed worksite. In fact, the current PEL of 2.0 f/cc has been exceeded in many cases in these sectors. Thus, it is likely that many workers in the construction and service sectors will develop cancer unless EPA takes action. Finally, many asbestos control measures, in particular, the use of respirators, only put the asbestos exposure problem elsewhere because they do not control the release of large quantities of asbestos to the ambient environment, where it continues to present a risk both to other workers and the general population. Similarly, CPSC cannot evaluate or deal with the totality of the risk presented by asbestos. CPSC may ban or require safety standards for asbestoscontaining consumer products based exclusively on risk to consumers. CPSC is unable to consider risk to other groups from releases of asbestos during the lifecycle of those products. After carefully analyzing other Federal authorities. EPA concludes that action under TSCA is appropriate to reduce he unreasonable risk to human health posed by asbestos. Use of other Federal authorities cannot reduce risk to a reaso table level because (1) they cannot educe the total volume of asbestos in commerce. (2) they cannot protect the many population groups at risk,, and' (3) they all have jurisdictional gaps VIII. Provisions of the Proposed Rule A. Prodict Prohibitions EPA iroposes to prohibit the manufa :ture. importation, and processing of several asbestos products. The prohibitions will take effect at thesame tine that the restrictions on the mining nd importation of all asbestos and astestos products become effective. Thus. Vi hen this rule becomes operational, no person could mine or import isbestos without a permit issued by EPA In addition, no person could manufa3 :ture. import, or process the followit g asbestos containing products: Asbestc s cement pipe and fittings. ! ielts, flooring felts (and felt1 sheet flooring), vinyl-asbestos floor til f, and asbestos clothing. EPA is proposi lg to ban asbestos clothing becaust it presents a particularly serious risk because of high exposure potentic 1. EPA is proposing to ban the other products because effective substitu tes are currently available for all applies! ions. As an alternative, EPA is conside ring banning these several asbesto i products by a date soon after the prot mlgation of this rule. B. Mini tg and Import Restrictions EPA i roposes to prohibit the mining or impo riation of bulk asbestos, and the importa ion of the asbestos products listed ir 5 763.145 of the proposal, unless the min sr or importer holds a permit issued l y EPA allowing mining or importa rion of that quantity of asbestos. EPA is ( onsidering the requirement that product i made under the permitting system je labeled as containing asbesto i. Labeling would ensure that persons working with or otherwise handlin ; the products would know that the proc ucts contained asbestos, and it would e nable them to take steps to reduce ihe likelihood of exposure. EPA [ roposes to reduce the amount of asbesto i that may be imported or mined in set di crements each year for 10 years. EPA pre poses to define "mine" as "to produce asbestos other than as an uninten led contaminant or impurity by extracti lg asbestos-containing ore so that the ore may be (1) distributed in commer :e or (2) milled for distribution in commerce." Thus, the unintentional mining of asbestos in connection with mining of another substance such as vermicuiite would not be covered by this proposal unless the asbestos were later milled or sold for use. EPA is concerned about possible unintended asbestos contamination of vermicuiite and other minerals. However, any attempt to cover the unintentional mining of asbestos under this rule would complicate the operation of the rule considerably and perhaps make it unworkable. The proposal defines "import" as "to bring into the customs territory of the United States except for (1) shipment through the customs territory of the United States for export without any domestic use or processing: or (2) entering the customs territory of the United States as part of a product during normal personal or business activities involving use of the product." Thus, asbestos that is shipped through the United States for export without any domestic processing or use would not be covered by this proposed rule. The proposed rule also excludes from coverage situations where an item, such as an automobile containing asbestos, travels across the United States border in the course of normal personal or business activities. In addition, asbestos contained in products that are imported in small quantities solely for personal use by consumers would not be covered by the proposal. Thus, under this provision an individual could bring an item such as a consumer appliance containing asbestos into the United States for his or her own use without obtaining a permit. EPA believes that any attempt to cover these situations would make this rule very complex and difficult to administer. However. EPA specifically requests comment on whether, in view of the serious health hazard posed by asbestos, ail asbestos products should be covered by this rule. This proposal covers mining and importation of asbestos and the importation of specific asbestos products. EPA proposes to define "asbestos" as "the asbesiiform varieties of: chrysotile (serpentine): crocidoiite (riebeckite): amosite (cummingtonitegrunerite); tremolite: anthophyllite, and actinolite that are mined or milled." EPA .requests comment on this definition, including whether asbestos which has been chemically treated or altered should be included within the definition. EPA also proposes to cover under this phase-down the asbestos contained in a number of products listed in 783.145 of this proposal. Persons would be allowed to import these products only if they held permits allowing the importation of the amount of asbestos contained in the SPI-00476 t l Federal Register / Vol. 5L. No. 19 / Wednesday. January 29. 1986 / Proposed Rules 3755 products. EPA is covering these particular products in this proposal because they represent the largest quantities of asbestos imported as part of products. EPA is proposing to cover asbestos in products because of the risk posed by possible asbestos exposure during use and disposal of the products and to treat domestic producers and importers of these products similarly. To implement this program, EPA is proposing that importers of listed products estimate the typical asbestos content of the products. To aid those estimates. EPA has ascertained the typical asbestos content of the asbestos products covered by this proposal. If persons do not know the exact asbestos content of products they import, they can rely on the EPA figures to estimate the amount of asbestos they import. EPA would allow persons to use an amount other than the EPA figure if they can show that their imported product contains a different amount of asbestos. Such persons would be required to maintain records supporting their determinations of typical asbestos content and would be subject to appropriate enforcement action if EPA discovered that their imported products actually had a higher asbestos content than they estimated. EPA believes that this is a practical way to implement the phase-down of asbestos use. C. Permits to Mine or Import Asbestos EPA proposes to issue current miners and importers of asbestos permits that would allow those persons to mine or import set amounts of asbestos. The permit would be letters from EPA stating the amount of asbestos that a person may import or mine during each year of the 10-year phase-down period. The "permitted" amount of mining or importation would be a uniform percentage of the average amount of asbestos each person mined or imported yearly during the base period of 1981. 1982. and 1983. The "permitted" amount of asbestos would be 30 percent of the person's average base year volumes during the first year of the phase-down period and would decline to 27 percent of average base year volumes during the second year. 24 percent during the third year and so on until it reached 3 percent in year 10. EPA chose these "permitted" amounts based on projections of future asbestos use after analysis of current use trends, publicly available information on asbestos use. and information reported under the section 8(a) asbestos reporting rule. In addition, the "permitted" amounts chosen reflect the EPA has proposed to ban certain high volume uses of asbestos where suitable substitute products are avilable. Persons would apply to EPA for permits, listing in their applications their Mining or import volumes during those years. Persons who do not apply for permits would not be granted any. EPA would compare volume information included in applications with information reported under the section t (a) asbestos reporting rule, which ( overed 1981. United States Customs i iervice data, and Bureau of Mines data. Persons who include false information in their application would be subject to < nforcement action, including criminal [ rosecution in appropriate cases. EPA'would similarly cover importers (f asbestos contained in the products 1 sted in this rule. Those persons would i pply for permits, including in their i pplication the total amount of asbestos i l their imported products during the 1 ase years 1981,1982. and 1983. Those [ ersons could use EPA's estimates of t epical asbestos content of products if tney do not know the typical asbestos t ontent of their product. The proposal contains an appeals f rocedure for persons who disagree with EPA's allocation of permits to t rem. However, since the proposed rule \ tould allocate each miner and importer uniform percentage of their base ^ olume levels. EPA would expect few ppeals. The only issue in an appeal \ rould be whether EPA allocated [ ermits based on the correct base ;. ears' % olume information. Persons would be allowed to transfer t leir permission to mine or import sbestos to other persons, including f ersons who were not issued permits by I PA. Permits issued to miners, importers c f bulk asbestos, and importers of sbestos in products would be i iterchangeable. Persons could transfer 11 or only part of their yearly permitted mount to one person or a number of f ersons. Persons transferring all of part c f their permitted amount would be r squired to report each transfer to EPA. Persons would also be allowed to reserve or "bank" permisison to import sbestos during any year of the phasec own period for use during any iater year of the phase-down period. Persons would be required to report each ' banking" of asbestos permits to EPA. A f erson who banks permission to mine or i nport a certain amount of asbestos v /ould be allowed to use only part of t lat amount during later years of the I hase-down period. The amount of sbestos mining or importation f emitted by banked permits would c ecline yearly at a rate of 10 percent, f ermits not used by the conclusion of t le 10-year phase-down period would no 1 inger permit the holder to import or mine asbestos in any quantity and would have no value of any kind for any purpose. EPA is considering an alternative of having banked permits not decline in value. This alternative would provide greater incentive for the banking of permits and thus incentive for greater reductions in asbestos mining and importation in early years of the phasedown period. Under the proposed approach, at the end of the 10-year phase-down period, all mining or importation of asbestos would be banned except that allowed under an exemption procedure. EPA would consider applications for exemptions and grant them for essential uses of asbestos for which substitutes are not available. In addition. EPA is considering a requirement that products not banned be labeled as containing asbestos. This requirement could be imposed as part of this rulemaking or by a separate rulemaking. As an alternative. EPA is considering allowing a residual amount of asbestos mining and importation after the "10-year phase-down period. This general approach would avoid the potentially heavy administrative burden and expense of an exemption process. As part of this alternative. EPA is considering allowing permits banked during the 10-year phase-down period to continue to be used during the later period when a much smaller percentage of base years volume is permitted. Such an approach would provide additional incentive for the banking of permits and thus additional incentive for greater reductions in asbestos mining and importation during early years of the phase-down period. EPA specifically requests comment on this series of alternatives to a ban with an exemption process after the 10-year phase-down period. D. Reporting EPA proposes to require persons to report the amount of asbestos imported during each import transaction. EPA specifically requests comment on whether this report should be sent directly to EPA or whether persons should turn the report over to the United States Customs Service, which would forward the report to EPA. Requiring the report to be turned over to the Customs Service as part of each import transaction may facilitate enforcement of the rule. The proposal also would require persons to report to EPA each transfer of permission to mine or import asbestos. This reporting would be under authority of section 0(a) of TSCA and SPI-00477 **&$* x h W iM l b... 3756 Federal Register / Voi. 51. ^o. 19 / Wednesday, January 29, 1986 / Proposed Rule3 would apply to all importers, including small businesses. Section 8(aJ exempts small businesses from reporting in certain cases. However. EPA may require miners and importers^ a ' substance subject to a rule under section 6 of TSCA to report. Since asbestos is already subject to rules under section 8 and would be subject to this one. the smail business exemption of section 8(a) would not apply. EPA believes that these reporting requirements represent very little burden and are necessary for effective enforcement of the phase-down rule. EPA would use the information in these reports to maintain a computerized record of the quantities of asbestos each person is permitted to mine or import as compared to the actual level of mining or importation. EPA would investigate cases where the quantity of asbestos mined or imported appears to exceed the quantity of asbestos that a person is permitted to mine or import and take appropriate enforcement action for any violation of the phase-down rule. To facilitate the transfer of permits. EPA is considering making readily available to interested parties information concerning the persons holding permits and the quantities they hold. EPA may allow persons computer access to an EPA data bank if this would not reveal confidential business information. EPA specifically requests comment on whether EPA should facilitate the transfer of permits and on ways for EPA to accomplish this without revealing confidential business information. E. Recordkeeping EPA proposes to require persons to retain documentation of information concerning all transfers of permission to mine or import asbestos and the amount of asbestos mined or imported each year. The proposal would require these records to be kept for 5 years after the end of the last year of the phase-down period covered by the rule. Importers of asbestos contained in products covered by this proposal would also have to keep records concerning their levels of importation. EPA believes that these recordkeeping provisions would be essential to enforcement of this proposed rule. IX. Enforcement Section 15 of TSCA makes it unlawful to fail or refuse to comply with any provision of a rule promulgated under section 8 of TSCA. Therefore, any failure to comply with this proposed rule when It becomes effective would be a violation of section 15 of TSCA. In addition, section 15 of TSCA makes it unlawful for any person to: (1) Fail or refuse to establish and maintain records as rjquired by this rule; (2) fail or refuse to p ;rmit access to or copying of recc rds. as required by TSCA: or (3) fail or r ifuse to permit entry or inspection as reqt ired by section 11 of TSCA. V olators may be subject to both civil and criminal liability. Under the penalty pro\ ision of section 16 of TSCA. any person who violates section 15 could be subject to a civil penalty of up to S25.0OO for t ach violation. Each day of operation in violation of this rule when it becomes effei tive could constitute a separate violution. Knowing or willful violations of this rule when it becomes effective coul i lead to the imposition of criminal pen; Ities of up to $25,000 for each day of vtoli tion and imprisonment for up to 1 year In addition, other remedies are avai able to EPA under sections 7 and 17 ol TSCA. such as seeking an injuction to re strain violations of this rule when It becomes effective and seizing any chemical substance or mixture man ifactured or imported in violation of this i ule when it becomes effective. Individuals, as well as corporations, could be subject to enforcement actions. Sections 15 and 16 of TSCA apply to "any person" who violates various prov sions of TSCA. EPA may. at its discretion, proceed against individuals as w ill as companies. In particular. Ed A may jroceed against individuals who repot t false information or cause it to o reported. X. C< nfidentiality A person may assert a claim of confi lentiality for any information, inclu ling public comments, submitted to EPA n connection with this proposed rule c r in connection with this rule after it is promulgated. Any person who submits a confidential public comment must also submit a nonconfidential version. Any claim of confidentiality must accompany the information when it is s jbmitted to EPA. Persons would claim information confidential by circlii ig. bracketing, or underlining it an.! marking it with "CONFIDENTIAL" or some other appropriate designation. EPA will disclose information subject to a clai n of confidentiality only to the exten permitted by section 14 of TSCA and 4 ) CFR Part 2, Subpart B. If a person does not assert a claim of confidentiality for in ormation at the time it is subm tted to EPA. EPA may make the information public without further noticf to that person. XI. Ri lemaking Record . EP/ has established a record for this rulem iking (docket control number OPTS--62040). A public version of the record, without any confidential business information, is available in tije Office of Toxic Substances Public Information Office, from 8 a.m. to 4 p.m. Monday through Friday, except legal holidays. The Public Information Office Is located in Rm. E-107, 401 M SL, SW., Washington. D.C. The record includes information considered by EPA in developing this proposed rule. EPA will supplement the record with additional information as it is received. The record now includes the following categories of information; (1) Federal Register notices. (2) support documents. (3) reports, and (4) memoranda and letters. EPA will identify the complete rulemaking record by date of promulgation. EPA will accept additional material for inclusion in the record at any time between this notice and designation of the complete record. The final rule will also permit persons to point out any errors or omissions in the record. XII. References (t| USCPSC. Report to the U S. Consumer Product Safety Commission by the Chronic Hazard Advisory Panel on Asbestos. July 1983. (2) USEPA. OPTS. OTS. Exposure Assessment for Asbestos. Draft January 9. 1984. (3) USEPA, OPTS OTS. Regulatory Impact Analysis of Controls on Asbestos and Asbestos Products. January 1980. (4) USEPA. OPTS. OTS. Support Document for Final Rule on Friable Asbestos-Containing Materials in School Buildings--Health Effects and Magnitude of Exposure. January. 1962. (3) National Research Council. "Asbestos" In: `Drinking Water and Health.'' Vol. 3. National Academy Press. Washington, D.C. (1932): 223-263. (3) Naiional Research Council. "Nonocr.upational Health Risks of Asbestiform Fibers." National Academy Prss. Washington. D.C. (1984). (71 NIOSH-OSHA Asbestos Work Group. Workplace Exposure to Asbestos: "Review and Recommendations" DHHS (NIOSH) Publication No. 81-103. U S. Government Printing Office. Washington. D.C. 26402. 11980). (8) OSHA. Quantitative Risk Analysis for Asbestos-Related Cancers: A Preliminary Report." (1983). (91 Seidman. H. Selikoff. I.J.. Hammond. E C.. "Short-Term Asbestos Work Exposure and Long-Term Observation." Annals of the Xrw York Academy of Science. 330(1979): lit-39. (10) Selikoff. l.|.. Anderson. H.A.. Seidman, H. "Asbestos Disease Among Household Contacts of Asbestos Workers" In: "Disability Compensation for AsbestosAssociated Disease in the U.S.." edited by I.j. Selikoff. Environmental Sciences Laboratory, Mount Sinai School of Medicine of the City University of New York. (1982): 73-78. SPI-00478 Federal Register / Vol. 51, IS o. 19 / Wednesday, |anuary 29, 1980 / Proposed Rules 3757 (U1 Selikoff. Hammond. E.C.. Seidman H.. "Mortality Experience of Insulation Workers in the U S. and Canada. 1943-1978." Annals of the New York Academy of Science. 330(1979): 91-118. (12) USDOL OSHA. "Occupational ' Exposure to Asbestos: Emergency Temporary Standard." (November 4.1983: 48 FR 51086). (13) USDOL OSHA. "Occupational Exposure to Asbestos: Proposed Rule and Notice of Hearing" (April 10.1984: 49 FR 14118). (14) USEPA. OPTS. OTS. Asbestos Substitutes and Related Materials. April 24. 1985. XUI. Regulatory Assessment Requirements A. Executive Order 12291 Under Executive Order 12291. EPA has determined that this proposed rule is a "Major Rule" and has developed an R1A. The RIA estimates that this proposed rule would cost about $1.98 billion over 15 years. However, the RIA also estimated that this proposed rule, if promulgated, would avoid approximately 1.930 cases of cancer. As shown in Unit V above. EPA believes that these costs are reasonable and that this proposed action is a cost-effective way of reducing the unreasonable risks related to asbestos. This proposed rule was submitted to the Office of Management and Budget (OMB) for review as required by Executive Order 12291. B. Regulatory Flexibility Act EPA has analyzed the economic impact of this proposed rule on small businesses. A summary of EPA's analysis appears in Unit 111. C. Paperwork Reduction Act The reporting and recordkeeping provisions in this proposed rule will be submitted to the Office of Management and Budget (OMB) for approval under the Paperwork Reduction Act. Comments on these requirements should be submitted to the Office of Information and Regulatory Affairs at OMB and marked Attention: Desk Officer for EPA. Any final rule will explain EPA's response to OMB and public comments on the proposed reporting and recordkeeping requirements. List of Subjects in 40 CFR Part 7*3 Environmental protection. Hazardous substances. Recordkeeping and reporting requirements. Asbestos. Da ed: January 22. 3988. Lee k i. Thomas, Admi iistrator. PAR ` 763--(Amended) Th trefore, it is proposed that 40 CFR Part '63 be amended as follows: 1." 'he authority citation for Part 763 is revis *d to read as follows: AuRjority: 15 U S-C. 2805 and 2607(c). 2 Ily adding new Subpart H to read as folio Subp4irt H--Asbestos Mining and Import Restr ctlona Sec. 7831. .143 Scope. 7631..14 3 Definitions. 7631..14 S Mining and import restrictions. 7631.14 r Permits to mine or import asbestos. 7631..14) Issuance of permits. 7831. .14) Appeals concerning permits. 7831.15) Transfer of permits. 7831.151 Banking of permits. 7831..151 Recordkeeping. 76633.15) Reporting. 783.15 > Enforcement. 7631. .15' Inspections. 763.159 ConfidenUality and public access to information. Subpirt H--Asbestos Mining and ImpoH Restriction* 763. 40 Scope. Thi i Subpart prohibits the mining or import,ation of asbestos, including asbes:os in certain asbestos products, unlesi: authorized by a permit issued 1 \ EPA. 763. 43 Definitions. The definitions in section 3 of TSCA. 15 U. J.C.. 2602. apply to this Subpart. In additiloin. the following definitions apply: (a) The terms "act," "article," "bypr iduct." "customs territory of the Unitep States." "EPA," "importer." "man ifacturer," "persons." and "United State: " have the same meanings as in 720 I of this chapter. (b) Asbestos" means the asbestiform variedes of: chrysotile (serpentine); erode olite (riebeckite): amosite. (cumifi;ngtonite-grunerite); tremolfte: anth',o()hyllite. and actinolite that are mineC or milled. (c) Asbestos product" means any mixtu e or artide containing asbestos. (d) Consumer" means a natural persoi i who uses a product for personal rather than business purposes. (e) Import" means to bring into custoifis territory of the United States for purpose except (1) for shipment throuj h the customs territory of the Uni States for export without any dome^tic use or processing: or (2) ntenng (he customs territory of the Ur ited States as part of a product during normal personal or business activities involving use of the product. (f) "Milled" means the separation of asbestos fibers from asbestos ore. the grading and sorting of asbestos fibers, or the fiberizing of asbestos ore. (g) "Mine" means to produce asbestos other than as an unintended contaminant or impurity by extracting asbestos-containing ore so that the ore may be (1) distributed in commerce or (2) milled for distribution in commerce. (h) "Miner" means a person who mines asbestos. 763.145 Mining and import restrictions. (a) Beginning the first day of the calendar year after this rule becomes effective, or if this rule becomes effective during the last 4 months of a calendar year, beginning the firs! day of the second calendar year after this rule becomes effective, no person other than a person authorized by a permit issued by EPA as provided in this part may: (1) Mine asbestos in the United States or (2) Import asbestos, including asbestos in an asbestos product listed in this section, except in small quantities solely for personal consumer use. into the customs territory of the United States. (b) The following asbestos products may not be imported into the customs territory of the United States except in small quantities by a consumer solely for his or her personal use unless authorized by a permit issued by EPA as provided in this Subpart: (1) Appliances. (2) Pipeline wrap. (3) Thread, yam, lap, roving, cord, rope, or wick. (4) Sheet gasketing, rubber encapsulated compressed. (5) Disc brake pads (light-medium vehicles). (6) Cloth, other than asbestos clothing. (7) Brake blocks. (8) Millboard. (9) Packing. (10) Mixed or repackaged asbestos fiber. (11) Thermoplugs. (12) Tape. (13) Roof coatings. (14) Clutch facings. " (15) Automotive gasket kit. (16) Drum brake linings. (17) Yam. (18) Automobiles and other motor vehicles. 763.147 Permits to mine or import asbestos. (a) Persons may mine in the United States or import into the customs SPI-00479 T "T* 3758 Federal Register / Vol. 51. No. 19 / Wednesday, January 29. 1986 / Proposed Rules territory of the United States only the quantity of asbestos for which they hold permits issued under this Subpart. (b) The amount of asbestos contained in imported product listed in 763.146 will count toward the total amount of asbestos a person may mine or import during a year. (c) Persons must estimate typical asbestos content of imported asbestos products covered by this rule. Persons may use EPA's estimate of typical asbestos content if they are not certain of the typical asbestos content of a product. $ 763.148 Issuance of permits. (a) (1) EPA will issue permits for the mining or import of asbestos, including asbestos contained in the asbestos products listed in 763.145. (2) Applications for permits must be sent to the Office of Toxic Substances (TS-792). EPA, 401 M St.. SW., Washington. D.C. 20460. (b) (1) Persons must apply to EPA for permits by 30 days after the effective date of this rule. (2) Persons must list in their application for permits the amount of asbestos, including asbestos contained in the asbestos products listed in 763.145. that they imported or mined during 1981.1982. and 1983. (c) If an application is mailed to EPA. the application must be postmarked by 30 days after the effective date of this rule. (d) EPA will allocate to persons who apply for permits a uniform percentage of the amount of asbestos those persons reported mining or importing during 1981. 1982. and 1983. (e) Each permit will allow a person to mine or import the following percentages of the average amount of asbestos he or she mined or imported yearly during 1981.1982, and 1983. Year 1--30 percent. Year 2--27 percent. Year 3--24 percent. Year 4--21 percent. Year 5--18 percent. Year 6--15 percent. Year 7--12 percent. Year 8--9 percent. Year 9--6 percent. Year 10--3 percent. 763.149 Appeals concerning permits. (a) A person may appeal EPA's initial disposition of his or her application for a permit. (b) The person must appeal in writing to the Director of the Office of Toxic Substances (TS-792). EPA. 401 M St., SW.. Washington. DC 20460. within 20 days after receipt of EPA's announcement of the disposition of his or her application. If the appeal is m.iiled, the letter must be postmarked within 20 days after receipt of EPA's announcement of disposition. c) A person must indicate in an ap leal why he or she should receive a pe mit or be allowed to mine or import adiitional asbestos under the permit. d) The Director of the EPA Office of Toric Substances will either grant or de ly the appeal within 60 days after its ret eipt. The disposition of the appeal wi 1 be announced by letter to the pe son making the appeal. 7 13.1 SO Transfer of permits. (a) A person issued a permit by EPA to nine or import a quantity of asbestos may transfer that permit in whole or in' pai t to another person. ()) A person who transfers a permit to 1 mit e or import a quantity of asbestos ant a person who receives such a tra; isferred permit must report that tra isfer to the Office of Toxic Substances (TS-792), EPA. 401 M St., SV\Washington. DC 20460, within 10 da; s of the transfer. (' The parties involved in a transfer ma report either jointly or separately. (i 1) If a report is mailed to EPA. the rep >rt must be postmarked within 10 days of the transfer. 763 151 Banking of permits. (i ) Persons issued permits by EPA to mine or import a quantity of asbestos dur ng one particular year may reserve or bank" all or part of the permitted am tunt and use it to mine or import asb stos during a later year during ti:e 10-:jeariphase-down period. (D The amount of asbestos that a peri ion is permitted to mine or import will decline from year to year when it is res>erved or "banked" at a rate of 10 peri< ent per year. (c) A person who "banks" a permit in wh e or in part must report that "ba iking" to the Office of Toxic Subfc tances (TS-792), EPA. 401 M St. SW Washington. DC 20460, within 60 day i of the end of the year for which the peril it was issued. (c) If a report is mailed to EPA. the rep<c rt must be postmarked within 60 day of the end of the year for which the "ba:liked" permit was issued. $ 76:. 153 Recordkeeping. (a Any person who mines or imports asbi stos or any asbestos product listed in 763.145 must retain in one location doci mentation of information showing: (1 The name of any person to whom he o she transferred permission to mine or in iport asbestos. The name of any person from who n he or she received permission to mmq or import asbestos. (3) The amount of asbestos mined or imported each year, including asbestos imported in any asbestos product listed in 763.145. (4) The typical asbestos content of any asbestos product listed in 763.145. (5) The number of individual asbestos products listed in 763.145 imported each year. (b) This information must be retained for 5 years from the end of the last year of the 10-year phase-down period covered by this rule. 763.154 Reporting. (a) Any person who imports asbestos, including asbestos in an asbestos product listed in 763.145. must report to the Office of Toxic Substances (TS792). EPA. 401 M. St. SW., Washington, DC 20460, within 2 days of the day of import indicating: (1) The person's name. (2) The amount of asbestos imported. (3) The number of individual asbestos products listed in 763.145 imported. (4) A certification that the person was either issued a permit by EPA to import at least that amount of asbestos that year or obtained that permission from another person as provided in 763.148. (b) Within 60 days of the end of each year covered by thia Subpart, each person who mines or imports asbestos including asbestos in an asbestos product listed in 763.145 must report to the Office of Toxic Substances (TS-792), EPA. 401 M. St.. SW.. Washington. DC 20460: (1) The total amount of bulk asbestos that person mined or imported that year. (2) The total amount of asbestos that person imported in asbestos products listed in 763.145 that year. (3) The number of individual asbestos products listed in 763.145 that person imported that year. (4) The amount of asbestos that person had permission to mine or import that year. (c) If a report is mailed to EPA. the report must be postmarked within 90 days of the end of each year covered by this Subpart. 763.156 Enforcement (a) Failure to comply with any provision of this Subpart is a violation of section 15 of the Act (15 U.S.C. 2614). (b) Failure or refusal to establish and maintain records or to permit access to or copying of records, as required by the Act, is a violation of section 15 of the Act (15 U.S.C. 2614). (c) Failure or refusal to permit entry or inspection as required by section 11 of the Act (15 U.S.C. 2610) is a violation of section 15 of the Act (15 U.S.C. 2614). SPI-00480 Federal Register / Vol. 51. No. 19 / Wednesday. January 29. 1986 / Proposed Rules 3759 (d) Violators may be subject to the civil and criminal penalties in section 10 of the Act (15 U.S.C. 2015) for each violation. (e) EPA may seek to enjoinlhe mining or import of asbestos or asbestos products in violation of this Subpart, or act to seize any asbestos or asbestos products in violation of this Subpart, or take other actions under the authority of section 7 or 17 of the Act (15 U.S.C. 2806 or 2610). 763.157 Inspection*. EPA will conduct inspections under section 11 of the Act (15 U.S.C. 2610) to ensure compliance with this Subpart and to verify that information submitted to EPA under this Subpart is correct. 763.159 Confidentiality and public access to information. (a) A person may assert a claim of confidentiality for any information he or she submits to EPA under this Subpart. (b) Any claim of confidentiality must accompany the information when it is submitted to EPA. (c) EPA will disclose information subject to a claim of confidentiality asserted under this section only to the extent permitted by TSCA and Part 2 of this title. (d) If a person does not assert a claim of confidentiality for information at the time it is submitted to EPA, EPA may make the information public without further notice to that person. 3. By adding new Subpart I to read as follows: Subpart I--Prohibition of tha Manufacture, Processing, and Distribution in Commerce of Certain Asbestos-Containing Products Se*c. 703.160 763 163 763.165 763.167 763.169 Scope. Definitions. Manufacture--prohibitions. Processing--prohibitions. Enforcement. Subpart I--Prohibition of the Manufacture, Processing, and Distribution in Commerce of Certain Asbestos-Containing Products 763.160 Scope. This Subpart prohibits the manufacture, importation and processing, of the following categories of asbestos-containing products: asbestoscontaining roofing felt, asbestoscontaining flooring felt (including vinyl sheet flooring backed with flooring felt), vinyl-asbestos floor tile and asbestoscement pipe and fittings and asbestos clothing. 763.163 Definitions. The definitions in section 3 of the Toxic Substances Control Act and the following definitions apply to this subpart. (a) "Asbestos" means the asbestiform varieties of: chrysotile (serpentine): crocidolite (riebeckite): amosite (cummingtonite-grunerite): tremolite; anthophyllite. and actinolite. (b) "Asbestos-cement pipe and fittings" means an asbestos-containing product that contains cement and is intended to transmit water or sewage; for use as conduit pipe for the protection of electrical or telephone cable: or for use as air ducts. (c) "Asbestos clothing" means an asbestos-containing product made of cloth and designed to be worn by individuals. (d) "Asbestos-containing product" means any material which contains more than 1.0 percent asbestos by weight. (e) "Flooring felt" means an ay estos:ontaining product made of papr. `"elt ind intended as an underlaymer.' for loor coverings, or to be bonded ' ; the inderside of vinyl sheet flooring (f) "Roofing felt" means an asbestos:ontaining product made of paper felt tnd intended for use on building roofs is a covering or underlayment for other oof coverings. (g) "Vinyl-asbestos floor tile" means in asbestos-containing product composed of vinyl resins, containing ifilers, stabilizers and pigments and used as floor tile. i 763.165 Manufacture--prohibitions. Beginning the first day of the calendar ! ear after this rule becomes effeciue. or ir this rule becomes effective during the I ist 4 months of a calendar year. 1 eginning the first day of the second c alendar year after this rule becomes e ffective. no person shall manufacture or import the following asbestoscontaining products either for use in the United States or for export: asbestoscontaining roofing felt, asbestoscontaining flooring fell (including vinyl sheet flooring backed with flooring felt), vinyl-asbestos floor tile, asbestoscement pipe and fittings, and asbestos clothing. 763.167 Processing--prohibitions. Beginning the first day of the calendar year after this rule becomes effective, or if this rule becomes effective during the last 4 months of a calendar year, beginning the first day of the second calendar year after this rule becomes effective, no person shall process the following products, either for use in the United States or for export: asbestoscontaining roofing felt, asbestoscontaining flooring felt (including vinyl sheet flooring backed with flooring felt), vinyl-asbestos floor tile, asbestoscement pipe and fittings, and asbestos clothing. 763.169 Enforcement. (a) Failure to comply with any provision of this Subpart is a violation of section 15 of the Act (15 U.S.C. 2614). (b) Failure or refusal to establish and maintain records or to permit access to or copying of records, as required by the Act, is a violation of section 15 of the Act (15 U.S.C. 2614). (c) Failure or refusal to permit entry or inspection as required by section 11 of the Act (15 U.S.C. 2610) is a violation of section 15 of the Act (15 U.S.C. 2614). (d) Violators may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C. 2615) for each violation. (e) EPA may seek to enjoin the manufacture or import of asbestos products in violation of this Subpart, or act to seize any asbestos products in violation of this Subpart, or take other actions under the authority of section 7 or 17 of the Act (15 U.S.C. 2606 or 2616). (FR Doc. 36-1881 Filed 1-28-86: 8:45 am) BILLING COO* SMO-SO-M SPI-00481