Document JrgGypopBe3YbkYENQpvpjwaK

To: Asbestos Information Distribution 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 hwbuio 1 3738________Federal Register / VoL 51. No. 19 / Wednesday, January 29, 1988 / Proposed Rules ENVIRONMENTAL PROTECTION dates: Public hearings will be held AGENCY beginning approximately May M. 198& The exact times and locations of the----- 40 CFR Part 763 hearings will be available by calling EPA's TSCA Assistance Offices. [OPTS-62035; FRL 2947-3] Comments on this proposed ruin and requests to participate in the inftmnaT Asbestos; Proposed Mining and Import Bearings must be submitted by April 29, Restrictions and Proposed 1588. Reply comments made in response Manufacturing, Importation, and {(Tissues raised at each hearingmustb Processing Prohibitions submitted no later than 1 week after the aqemcv: Enviromnental Protection Agency (EPA). cTose of that hearing. address: Since some commentsare expected to contain confidential action: Proposed rule. business information, all comments SUMMARY: EPA is proposing a rule under section 6 of the Toxic Substances Control Act (TSCA) to prohibit the manufacture, importation, and processing of asbestos in certain products and to Phase out the use of asbestos in all other products. The products ttPA proposes to ban are asbestos-cement pipe and fittings, roofing felts, flooring felts (and felt- backed sheet flooring), vinyl-asbestos floor tile, and asbestos clothing. Under this rule, EPA would also allow only those personi with permits issued by EPAtomine 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 die serious unreasonable risk to human health presented by exposure to asbestos. As should be sent in triplicate to: Document Control Officer (TS-793), Office ofToxic Substances. Environmental Protection Agency, Rm. E-209,401 M St SW, Washington, DC 20480. Comments should include the docket control number OPTS-62Q38. Nonconfidential comments and nonconfidential versions of confidential comments received on this proposal will be available for reviewing and copying from 8 a.m. to 4 p.m.. Monday through Friday, excluding legal holiday* in Rm. E-107, at the address given above. FOR FURTHER INFORMATION CONTACT: Edward A. Klein Director, Office of TSCA Assistance (TS-799), Office of Toxic Substances, Environmental Protection Agency, Rm. E-543, 401M St. SW., Washington. DC 20480, Toil free: (800-424-90651. In Washington. DQ (554-1404), Outside the USA: (Operator--202-554-1404). an alternative, EPA is considering SUPPLEMENTARY INFORMATION: prohibiting the manufacture, importation and processing of categories of asbestos 1. Introduction products at staged intervals. EPA is Asbestos, since the advent of its large considering banning the manufacture. scale use, has resulted in thousands of importation, amforocessing of asbestos painful, premature deaths from lung -------------------- - j--*1asbestos cancer and other diseases.Jterause nf the wiriesprenA nse of asbestos and its promulgation with the category of particular nature, piecemeal control of asbestQSLfrirtinn prnrinrlg hanged about the nsKsTit presents is notsatisfactorv; 3 years later, and other asbestos Only elimination of asbestos to the products banned at a later time. .EPA extent feasible will produce acceptable believes that this alternative approach reduction of risks. Prevention of farther would also be an effective way of Jeaths^tbergfqre, requires forceful. reducing the serious unreasonble risk ^fntegrateH'actioihagainst asbestos risks. presented by exposure to asbestos and To achieve this end, EPA has specifically requests-comment on a established a coordinated asbestos staged ban of asbestos product program, aimed at controlling exposure categories. Finally, under both this to asbestos from products already in use alternative and the proposed approach, and eliminating risks from future uses. -EBAis considering requiring labeling for The rule EPA is proposing today, which all asbestos products that are not would ban certain uses of asbestos and Banned, including products phase out all other uses, forma s central 'manufactured pursuant to permits element of this program. Regulatory issued bv friPA during the nhase-dnwn alternatives, which are discussed in this period, orpui-snant to an exemption. notice and which involve staged baas of process-The Agency requests comments various asbestos product categories* onTKefeasibility and effectiveness of could also form a central element of tfss such a requirement. program. 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 rases 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 85,000 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 i 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 is 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 j 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 i 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 ofrelease, 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 19M. hundreds ot ~ products are still made with asbestos. including paper and textiles, cement pipe and sheets, tiles and felts, and automobile brakes. Asbestos fibers are > releasedto the air at many stages of the : commercial life of these products. Typical activities that lead to the I iwiftti&ssaSti HWBUI0001296 Federal Register / Vol. 51, No. 19 / Wednesday, January 29, 1986 / Proposed Rules 3739 release of asbestos include the mining of both indoors and outside of buildings workers may die from an asbestos- asbestos,fiber processing into product* (Ref. 6). Therefore, any comprehensive felated disease. Furthermore, it is installation of products (e.$, the sawing, - control strategy must take into account unreasonable to assume complete drilling, and sanding associated with- the potential for exposure during the compliance with a PEL of 0.2 f/cc, asbestos-cement prodacJsfcpjrodtjet u< entire lifecycle of asbestos products. especially given the nature of the (e.g., release of fibers during use of To date. EPA has focused its attention asbestos industry. Many of the workers asbestos cloth), product maintenance primarily on asbestos in buildings, a exposed are in the service and (e.g,, buffing and gcrapingof virtyl- : major source of asbestos release into the construction industries, where worksites asbestos ftooe tileor repair ofasbestos- ambient environment hi the 1970b, EPA change frequently and the worker containingbrakes),dismantling and - banned the use of sprayed-on asbestos population is transient Also, workers. - remoyalof products (eg., removal of andashesto-containing pipe lagging often do notknow they are exposed to asbestos roofing felts}. and disposal under the Clean Air Act, and Since then asbestos and therefore will nottake the Release of fibers from these activities has taken steps to reduce risks from necessary precautions. As a result PELs is snbstantiaW resulting In exposure to asbestos already in place in buildings. It and other exposure controls are difficult both workenrand non-workers. EPA - has issued an air standard to reduce tu apply and enforce. Beyond these eatimatea that about 700-metric tons are emissions from asbestos removal and considerations; a workplace-based released to the air duringmining and. renovation projects in buildings; issued approach does not address risks to the 'milling eacbyear. about lOOi metric tons a rule requiring inspection of schools for general population. EPA estimates that. during produce manufacture, and-about- friable asbestos; and established an even if OSHA reduces the PEL to 0.2 f/ ~ 10 metric tona from landfills. These " extensive technical assistance program, cc. almost 1,325 cancers will still result ~ 'eatimatea are probably low because which provides guidance to public and iwm asbestos products made over the they do not include releases from private building owners on die next 15 years. secondary fabrication of such products identification and safe removal of "Because of this residual risk. EPA is as millboard and asbestos-cement sheet, asbestos. EPA has also proposed an proposing under section 6 ef TSCA a much of which is done in small shops immediately effective regulation to ban on the manufacture, importation, with inadequate emission controls. protect State and local public employees and processingof asbestos-cement pipe Observations that levels of asbestos in who take part in asbestos abatement and fittings; roofing felts, flooringfaftsu. the air near manufacturing plants and in activities. (and felt-backed sheet flooring), vinyl- cities are considerably greater than rural These actions are primarily remedial, asbestos floor tile, and asbestos background levels seem to confirm that addressing risks from asbestos already clothing. Thosauses would be banned-. these releases occur and are significant. in place; they do no address the because safer, economically competitive Release of asbestos fibers occurs not substantial risks that will result from the substitutes are available, and because only in the manufacture and processing continued manufacture and use of these asbestos uses are likely to of asbestos products, but also in their aibestos. Several other Federal agencies contribute large amounts of asbestos to use and maintenance. Tins release can have already taken steps that partially the ambient environment or present occur without the knowledge of the user reduce these risks. The Occupational disproportionately high risk. ' or maintenance personnel. For example, Safety and Health Administration In addition. EPA is proposing to construction workers tap into asbestos- (OSHA) has an occupational standard . establish a permit system to phase out cement pipes already in place. The for asbestos with a permissible all other asbestos products. Under this workers often do not know that the pipe exposure limit (PEL) of 2.0 f/cc. OSHA system. EPA would allocate permission contains asbestos and thus do not take has proposed to lower this standard to to mine or import a specific volume of steps to limit fiber release. Similarly, either 0.2 or 0.5 f/cc. In addition, the asbestos to current miners and " S'significant releases occur as a result of Consumer Product Safety Commission importers. The amount of asbestos a ( the use and repair ot asbestos brakes (CPSC) has banned use of respirable miner or importer would be allowed to- \ Ihd other friction products, which asbestos in consumer patching flringofTmDort wnnlri ifer.line every year I 'constituted about 22 percent oftKe total compounds and artifical emberizing J asbestos market in 1984. AmbienTlevels materials. However, substantial risk to importation would be allowed, except / ot asbestos are elevated near freeways. workers and the general population under a specific exemption. This permit ( flresumable due to release from asbestos remains. For this reason. EPA believes system would allow the market to thatTinlv a major regulatory initiative allocate asbestos, based on the- VfTfius, the manufacture, processing, under TSCA leading to the eventual availability and coitofasbestos and use of asbestos products leave a elimination of most asbestos produgt substitutes. After 10 years, EPA would legacy of asbestos in the ambient air. "manufacture ancTunportaiion can put in plice an exemption system for This ambient loading, while difficult to satisfactorily reduce the overall risk to those asbestos applications for which no quantify, is a significant problem. The "ail segments of the population substitutes had been developed. KFA~ National Academy of Sciences; after The limitations of exposure-based anticipates that there will be few such analyzing studies of outdoor air, regulations in preventing asbestos-fiber applications, because the permit system estimated typical concentrations of release, and the need for more would create strong incentives far the asbestos in outdoor ambient air in urban comprehensive action under TSCA, are development of substitutes. EPA'is also areaa to be approximately 0.00007 f/cc illustrated by the use of PELs to control considering a requirement that all (Ref. 8). Many millions of people are workplace exposure. In the first place, it asbestos products that are not banned daily exposed to these levels of asbestos appears infeasible to set a PEL for be labeled as containing asbestos. This in the air. The National Academy of asbestos low enough to reduce risk to a would apply to products made pursuant Sciences hajalaoestimated tEST satisfactory level. Even at 0.2 f/cc. the to permits issued by EPA to mine or persons in urban areas faceaBfetime lowest PEL proposed by OSHA. OSHA. import asbestos, and to products made 'risk offieTween abouTl in 100.000 taC using the same lung cancer and pursuant to an exemption process. aboutTin 100.0Q0ofdeveloning cancer mesothelioma models used bv EPA, In encourapng the development of as a result of asbestoamifae amhientair. estimates that about 7 in 1,000 asbeatoa. substitutes, EPA will be promoting a. I ! 7 J. i. HWBUI0001297 Federal Register / VoL St- Wat. 19 / Wednesday, January 2ft 1888 f Proposed Rules significant redaction or risk. Currently, all produces tint am replacing asbestos in its many urea appeal to present tawet '~As explained own felly later.EPA is alsaactively considering other, approaches to carry out a regulatory policy ofphasing out the manufacture, importation. and processing of asbestos products. Approaches under consideration include bennma categories ofasbestos products at staged interwdfc Two categories umter consideration are asbestos construetion products and aabegtos&TCtion jiroducta. themannfanture. impnrtatiniLand EPA teeonridsring this category approachbetase 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 construetioa products category and the friction products category contain products that engidiubstihtte tor other products in the category it ail are not barmedTThua. category may I risk most eifgctiygly. EPA also considered referring asbestos risks to Ostia and cpsC under section 9 of TSCA EPA decided agamstthis approach because OSHA an<F aotu cannflt adequately reduce the risk, given their authority and current coatrdT^ technologies. Theseagencies cannot comprehensively reduce the total volume of asbestos in commerce and cannot protect aii of the many population groups at risk. Thus, action by these agencies tender their separate authorities would still leave a large residual 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 tbe manufacture, importation, and processing of asbestos and asbestos products is the surest and most effective strategy far eliminating these risks. EPA announced that it was exploring possible use ofTSCA to reduce the risk to human health from exposure to. asbestos in an Advance Notice of Proposed Rulemaking (ANPRJ published in the Federal Register of October 17, 1979 (44 PR 90061). Following publication of the ANFR. EPA investigated industrial and commercial uses ofasbestos, l&tder section 8(a) of TSCA EPA promulgated an asbestos reporting rule under 40 CFR 783.96 published in the Federal Megteter of July 30.1982 0*7 PR 33207). This rule required miners, millers, importers, and processors of asbestos to report information concerning ft) quantities of asbestos used hr pmdact manufacture, (2) employee exposure to asbestos, (3f waste disposal practices, and (4) emission controlpractices. Hie information reported under that rule has been used with other data, to evaluate the risks and benefits of asbestos use. Under section 21 ofTSCA a person may petition EPA to initiate a proceeding for the issuance, amendment, or repeal ofa ride under various section*ofTSCA. On June 21. 1979, EPA was petitioned to prohibit the future use ofasbestos-cement pipe hr water systems. EPA granted that petition by a notice published in the Federal Register of October 15,1979 [44 FR 60155). On September 12 1984, the Natural Resources Defense Council (NRDC) petitioned EPA to prohibit further use of asbestos in motor vehicle brakes. EPA granted that petition by a notice published in the Federal Register of December 1A 1984 (49 FR 49311). This proposal is hr part a result of the proceedings conducted after granting those two petitions. EPA has identified effective substitutes For asbestos-cement pipe and is proposing to ban that product. EPA analyzed the availability of substitutes tor asbestos m brakes but isiris not prepared to propose an immediate Ban Effective substitutes are not f of asbestos in brakes. Instead. EPA is _ lidering a ban of asbestos friction products about 5 years after this rule is promulgated. TfI'lEI.WJ.il'hM-lWiitl also encourage the rapid development of substitutes. III. Regulatory Assessment Section 6 of the TSCA authorizes EPA to prohibit or limit by role the amount of a chemical substance which may be manufactured, processed, or distributed in commerce if EPA finds that there is a reasonable basis to conclude that the , manufacture, processing, distribution in< commerce, use. or disposal of the chemical substance, or any combination) of such activities, presents or will present an unreasonable risk of injury|| health or the environment Undersection 6fc)(H of TSCA, EPA must consider the following factors when determining whether a chemical?' substance or mixture presents an < unreasonable risk: (1) The effecfajBfsuch substance or mixture g^healthjtttd the magnitude of th<tfxposii^oil human beings to such substeHEifor mixture. (2) The effects of such substance or mixture on the (fnvSmmiBtjaiid the majpiitade of thg^ScpoSiggjrf the environment to sneb substance or mixture. --_ (3) TbefhengfitsoF such substance or mixture for various usee and the availability ofgCfiTtftujgSfoT such usest f4>The reesonaBfyascertainable CgconomleconBcdnertCcs of the rule. aRt comnderation oftKeeffeet on the national economy, small business, terfmotogicaf'innovation. the environment and public health. After considering die 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 jiealtli effeSnJilie unit summarizes me health effects of asbestos. Detailed discussion and assessment of the health effects of asbestos may be found in tbe "Report t the United States Consumer Product Safety Commission (CPSC) by the Chronic Hazard Advisory Panel on Asbestos" (CHAP) (Ref. t), "Health Effects and Magnitude of Exposure" in EPA's "Support Document for Final Ru an Friable Asbestos-Containing Materials in School Buildings," (Ref. 4) and the "Report of the (National Research Council) Committee on Nonoccupational Health Risks of Asbestifarm Fibers" (Ref. BJ. EPA finds that the adverse human . health efforts from exposure to asheat 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 bee repeatedly identified are asbestosis. lung cancer, and mesothelioma. Alsoassociated with asbestos exposure in same studies aw cancers ot the larynr HWBUI0001298 gagfatar l VoL S% No. 19 / Wednesday, {angary 29; 1P8B / Ptopoeed n SMI 85^M^Mui^SiSll5^e5i*S5e2ecJB are discusaed befow> Lung cancer ia eunentiyrespansiblefor the largest number ofdeaths from exposure to asbestos. fthas bees associated with exposure to all the principal,commercial asbestos fiber types. Excess King cancer hag been documented'in groups involved with the mining andmilling of asbestos and the manufacture and use ofasbestos 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 oflung 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 nonsmokera exposed to asbestos. Most persons who develop lung cancerdie 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 fine body cavities. Mesotheliomas occur in the pleura (the membrane that surrounds the Kings and lines ths-lnng 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 chrome disease associated with exposure toasbestos. There is no effective treatment for asbestosis and it is often cfisabling 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 long 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 concenNations in the air were high (more than 10 fibers per cubic centimeter (f/cc)) asbestosis has accounted far more than 7 percent of observeddeaths (Ref. 11). It ia apparently less common than lung cancer or mesothelioma at exposures lower than the current Occupational Safety and Health Administration (OSHA) workplace standard of 2Jt f/cc. Some recent data on the incidence of asbestosis appear compatible with a linear exposure-response relationship with no threshold (Ref. 12). However, it is still considered uncertain whether asbestosis occurs as a result of nonoccnpathmal exposures. In occupational studies where the primary route of exposure is through inhalation, lung cancer and mesotheliomas usually account for about 90 percent of the excess cancers seen among workers exposed to asbestos. However, as noted in the CHAP report (Ref. 1], a number of other cancers, principally of the gastrointestinal tract have been associated with asbestos exposure. These are cancers of the larynx, pharynx, oral cavity, esophagus, stomach, colon, and rectum. Statistically significant excesses of cancers of the kidney and ovary have also been shown. In addition, the excess of cancers at all other sites combined is statistically significant in some studies. The conclusions from epidemiology studies concerning the health effects of asbestos are also supported by results of laboratory studies. Animals treated with asbestos have shown increased incidence of fibrosis, lung cancer, and mesotheliomas. All commercial forms and several other types of asbestos are implicated from a variety of modes of exposure. Most occupational studies have been conducted on populations exposed to high airborne concentrations of asbestos for relatively long periods of time. However, short-term occupational exposures have also been shown to increase the risk of lung cancer and mesothelioma. One group of asbestos factory workers with less than 2 months of occupational exposure had a twofold increase in lung cancer risk (Ref. 9). In addition, there are many documented cases of mesothelioma linked to extremely brief exposure to high concentrations of asbestos or long-term exposure to low concentrations (Ref. 4). Direct evidence of adverse health effects from non-occupational asbestos exposure also exists. Persons who lived in the households of asbestos workers have developed pleural mesothelioma and asbestos-related radiographic changes. In an ongoing study. 4 cases of mesothelioma have been diagnosed amrnig BUI family contacts of amostte workers (Ref. 10), These figures are much higher than that expected to be found among the general population, fat addition, 35.9 percent of the contact! showed chest x-ray abnormalities as compared with 4A 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 1,000 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 ofgastrointestinal tract cancels that has frequently been found in occupational groups exposed hr asbestos in the air, there has been much study of the possible health effects of ingestion of asbestos fibers. Despite those efforts, evidence showing health "ambiguous. discussed above, numerous 1 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 fang: cancer, several models may be nsed to extrapolate from risk at higher exposure to risk at lower exposure. The model that EPA believes ia most consistent witiTtEFavaiiable human and animal data is the linear non-threshold dose/ response model. This model assumes that (l) any exposure increases risk, and (2j the increise in risk is proportional to the background nsk in the nonexposedr population and to the level of exposureT 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 asbestosexponurerelates disease HWBUI0001299 iffirs nr..i,>i, 11. .^arn.n n.iawratf rtw .'Tirr' 3742 Federal Register / Vol. 51. No. 19 / Wednesday, January 29, 1986 / Proposed Rules incidence to dose and the time from first THfftTSoweft Tfife mddri reflects a delay tor minimum latency period) of 10 years between firstexposure and the likely earliest possible appearance of the disease. Kith the lung cancer and mesothelioma models have also been adopted by OSHA (Ref. 12). The - National Research Council Committee on Nottoccupational Health Risks of Aabefctiferm Fibers also adopted a - simitar linear no-threshold model to estimate risk to oonoccupational populations from exposure to asbestos (Ref. 6). 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 asbestasis and cancers other than lung cancer and meBothelioma 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. A3 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. 6) ^--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.. chrysotile 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 chrysotile 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 hern used in the United Kingdom and other countries to rationalize different regulatory controls for crocidolite and chrysolite. However, in-view of the laboratory evidence and great uncertainty about the nature of the fibers of asbestos to be found in nonoccupational exposure situations, the committee decided not to differentiate among them in the quantitative risk assessment Furthermore, some of the apparent discrepancies may be explained by differences in physical properties of the fibers, their concentrations, and their characteristics in the different environments. These possibilities need further testing. In view of this uncertainty about the Relative potency of the various asbestos types and in view of the welldocumented health hazard of the most common commercial form ot asbestos. EPA has concluded that it is prudent to 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 were applied by injection or implantation suggest that longer and finer fibers are more carcinogenic than shorter and coarser fibers. This has not however, been confirmed by inhalation studies. 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 range of dimensions, including those suggested as most dangerous. Second, it has not been clearly shown that short fibers pose a significantly smaller risk. No dimensional threshold for potency hgajfgenjgitablished. C3- MagnuOtie of human exposure? Asbestos fibers are released to the air during all stages of the lifecycle of asbestos products. Fiber release to the air occurs during normal operations of mining and milling, fiber processing into products, installation of products, product use. maintenance, renovation, dismantling, removal, and disposal. Asbestos fibers have special characteristics that affect exposure. They are colorless, odorless, and frequently invisible except by microscope, thus presenting risk to persons who are 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. They are basically nonbiodegradable and therefore persist for a very long time in the environment. Asbestos fibers easily reenter the atmosphere after settling out and can travel long distances through the air. A report from Finland found that asbestos had traveled as far as 27 kilometers from a mine under study. Persons can be exposed to asbestos fibers long after those fibers have been released to the ambient air and a considerable distance from the source of the release. Asbestod fiber concentrations have been measured in areas far from obvious asbestos sources. Atmospheric samplin programs conducted in remote rural areas in the United States and German' have found asbestos fiber levels between 0.01 and 0.12 nanogram/metertj (ng/m3) (1 ng is one billionth of a gram), Conversion factorsbetween asbestos fiber counts and mass counts are variable. However. EPA estimates that ng of asbestos in air equals about 30* fibers visible by light microscopy. Usin; this conversion factor for asbestos in outdoor air. then the above measurements are the equivalent of about 3X10"1 to 3.6X10"8 f/cc. In are of higher human population density, measured asbestos concentrations in air are typically much greater. A survey, of large cities showed mean readings of 2.6 to 5.0 ng/m* (7.8X10-* to l-5x 10"' cc). Measurements taken in New York City ranged from means of 8 to 30 ng/m1 (2.4X10"' to 9X10"' f/cc). Typical fihi rnnnentraMnna are much higher jn~ densely populated areas because of fihi release from construction work_~ (including reitovaflonor demolition!. from asbestos-containing brakes of fnotorvehicies, and from other actn-itia during the lifecycle ot asbeltospraducti In general, levels of asbestos in the air i cities and near manufacturing plants an considerably greater than rural background levels. r 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 load, 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 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 ofasbestos products. Some products do not present as mudfe 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 d HWBUI0001300 / Voi. a. W8 / Wetfeesday, January 28. Mfifl / Proposed Ketef pipe sincett-iewitunoidy buried in the groufid. A large proportion ofdia UA population to at risk froartliie'sabeatos in drees. Tabteslthsoa^LBsiiovvthe numbers ofpersona exposed Heasbestos during the atom readily quantifiable stages of tirelifecydoof asbestos product# and tbs levels to which they are exposed. Exposure levels are "best eatHnates" based an monitoring studies. Additional information can be found hi Refs. Z and3 which are ineluded in the rulemaking record. To avoid disclosing conftefentfirf business information, the fables sometfines use a range rather than a single number. The notation NA means thatdata are not available. Tabus k-^etrasuRE (Merit for MANUFAcrufiNe--Occupational TA8EE tib--Exposure Data for Msaurxcwwmn AsmtwT AatwaAinsm SvS'oS Numbarof PWKM mpomA 00966 B*ar-*d6 g*sfct Pwar.------------- 00768 .06966 Sifurmwft foUna HO i rvpjtwf fan 60160 NA Fett-Metced vinyl flooring.._______ RaftAACN>ML~~ . - * .0495 NA 3.07 rzxff 10000 30.000 15*000 350,000 90.000 209000 50006 HA 96JOOO 660,000 NA t.700.000 790.000 TABLE tt-Beecauns Data for MMmFACTWtMe--Ambent--Continued still occur after their import into this country. Exposures will occur during AfibABlDl pratod r &4XMU* SfivftfUG* NMnbarcf pww installation and use of the product; maintenance of the product: and during dismantling, removal, and disposal of the product Mach asbestos can be G--wpMAATC MmmI , nfrsr hr^TI 1W hrakstf Brakt*x**_-- ------------ Friction produrb mflrwmir traw. Frict>pjriwfi nwnmiirbl, released to the ambient air as a result of 107 3.07 Tojm 310.000 these activities, targe numbers ofpeople 720.086 are exposed to asbestos during these . nnSt aaooeo NA 459.000 activities and the level of exposure cm be quite high. Significant exposures will also occur mm NA during the domestic Me cycle of bulk fMm J asbestos and asbestos products TlKMft Htate .0554 TtSMk 00002 HS na 160,006 90000 2.000,000 4,350.006 1,320006 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 miffing ofasbestos andmanufacture of asbestos products, fir addition, Table Bt.--Exposure Data For Irwtaffaaon, families ofworkers, and populations . Use Repair, and Disposal living near mining and manufachningf sites are also exposed to asbestos as a result of these activities. &qtewrf Numbar oi panon Hub Expo* fwtf S5m Ntnfcar of PW> oxpom6 5. Exposure pom various categories of QSt/CotOa pnNRfEIS crA i18b DOica SNR varioss categories of asbestos pracfihfis present very similar exposure patterns. m NA NA NA For example, theproducts within the- 107 NA 75 NA NA NA NA NA construction products category aH ' present significant potential for fiber .NA 120 HA NA 96 NA HA NA releaseto the air and subsequent human exposure during theirinstallation 166 1ST? NA 160 itask NA NA NA NA 130 76 NA 90 5JQ0 NA MA repair, removal, and disposal. These NA NA products are often cat tom, sawed, and NA drilled during installation repair, and NA removal. All of these activities can NA 5.000 4J00 4,700 4700 m NA NA NA NA NA NA NA 27.326 NA NA 4147 NA NA 79 NA NA 3,065 . NA MA W 250 388.144 NA 106 164039 NA 105 9,145 NA NA NA NA 250 36.1*4 release fibers to the air. In addition, sanding of these products doling use often releases fibers to the air. iSmiiariv. productswithin the friction products category all present iMfiaaf rreteaaes t exposure during use and repair. FriciioiLMndgctswear down ~ NA NA NA NA during use, often releasing fibers to the ' air either during actual use oftfce- NA NA NA 866 m NA NA NA prdggct or daring maintonencsorraate^ NA operations in i ' * " '' 1.386 4566 NA NA asEistos-contginins dust fe disturbed 92 2&H 120 100006 MA NA NA m pd becomes airborne. . ^ NA NA NA m / Often, fiber releases from asbestos NA NA NA MA NA 406 MS 3000 products in these categories occurto 1 NA NA NA NA close proximity to other product* witbfnf HA m NA NA the same category, making it (fiflfedt ter attribute observed fiber levels to a orted and particular product For example. EPA exporimtagbestos andasbestos products. EPA has determined that significant exposure is likely from used monitoring data from automobile repair shops to estimate asbestos exposures resulting front repair of imported asbestos products. Although some exposure to United States populations is avoided when asbestos asbestos disc brakes, dram bninL clutch facings, and automatic ' transmission friction cotnponreute. products are manufactured abroad and Because there are no data available to imparted rather than manufactured sstimste differences to fiberrelease* ! domestically, significant exposures witf- the various repair activities, EPA - v HWBUI0001301 rtwnurn. 3744 .Xsdatal Register / Vol. 51. No. 19 / Wednesday. January 29. 1986 / Proposed Rules developed exposure estimates for each calculates that this rule would avoid, product using a weighting scheme based about 1,000 of those potential cancers. on- the relative production volumes of TEPA also calculated the number of each of the friction products which are potential cancers avoided by the the sources of the exposure. Similarly, it regulatory alternatives discussed later. 1 is common for many of the asbestos Asaummi current exposure levels. t construction products to be used at one f building site, making it difficult to 1 alternative 1. which would ban the asbestos construction products category , attribute fiber release to one particular and asbestos clothing soon after i product, 'ffiuTeaTfiBation ofambienl " j exposures due to releases from '.indiyidualconatructionproducts. such 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 tenorial approach to analyze the risk __________ . i and to control that risk. Table tv lists the products that are included in the construction products and friction products categories. promulgation of the nils and ban the asbestos friction products category abouts years-later, would avoid about ZiOO cancers; alternative 2. which 'would ban 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 the remaining asbestos products about 10 years later, would avoid about 2.120 cancers: and alternative 3r which would ban the asbestos construction products category and asDestos clothing soon after promulgation of the rule and cover all other asbestos products under the Table IV--Examples of Asbestos Product phase-down, would avoid about2XE0 Categories Asbestos product category Construction product category. Fncttxr prtxfcicta Unaeturated roofing rett. ed roofing felt Flooring tetL Vinyl asbestos door title. Felt* backed vinyl flooring. A/C pipe. Corrugated A/C sheet Rat M --C sheet A/C sheet shincia---- Drum brake firing. Osc brakes (LV). Disc brakes (HV). Brake Mocks. Clutch facings. Fnceon producti--automatic transmis sion. Fnction products--commeroal 6. Quantitative cancer risk estimates? Asctiscussed 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 2.560 lung cancers and mesotheliomas in the United States would result from production of asbestos products over 15 years without that thisndewould avoid about l.g:ffl~nf those potential cancers. Assuming that OSHA achieves strict compliance with a PEL ofOZ f/cc, EPA calculates that about 1,325 lung cancers and_I ffteibtheliomas would result unless EPA takes action under TSCA. EPA EPA believes these estimates of potential number of cancers, and therefore the potential number of cancers avoided, may be low for the following reasons: a. The estimate is based only on exposures resulting from manufacture of asbestos products through the year 2000. Vithout regulatory action, manufacture bf asbestos products may continue beyond that date. b. The risk estimates often do not include cancers from consumer and other nonoccupational exposures to asbestos since data are either unavailable or uncertain. However. EPA believes that many people in these categories are at risk. An estimated lifetime risk of cancerof about 1 in f00.000 to about 7 in 100,000 exists for anyone who merely resides in a major city from exposure to asbestos in the ambient air both indoors and outside of buildings. [Ref. 61. Any additional exposure from asbestos products, such as consumer renovation of a house containing asbestos products, residing or working near plants that manufacture asbestos products, or residing or working in the vicinity of a construction project where asbestos-containing products are being installed or removed, will add to the risk of cancer. This additional exposure could increase the lifetime risk of cancer by more than an order of magnitude. c. The risk estimates did not include all workers whose occupation causes them to come in contact with asbestos products. For example, the estimates do not include occupational exposure during repair, removal, and disposal of r 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 c the dose-response relationship for mesothelioma and lung cancer. Risk estimates more than four times as high ! Jcould be justified {Ret 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 t 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 i worker populations and possibly among! other populations as well. In addition, h| a major study of insulation workers j exposed to asbestos, about 10 percent c all excess deaths were attributed to cancers other than lung cancer and mesothelioma (Ref. 11). 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 8(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 stitu 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 application! 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. HWBUI0001302 Federal Register / Viol. SI, No. 191 / Wednesday, January 29. 1986 / Proposed Rtilgg3745 r*8ts. V^StmMKt Tuu 'of Asbestos Pnooucrs. Their Major Uses, and the Extent to WMch Thcv Can be Substitut ed 1 Eater* to write** ' mtnMAm are ra fMttMWfiK1MD EMM? PrtM* WaflKl pip* BrckinjWW Saturated roofing ton. Unsafciated ? roofing felt product*.- tontouctlonor bufit-ip roofing. Vinyi/aito<>fOB floor** Asbmto+tott- bflcMdvtop sheet floortog. Floor tt buftSng*.' A general floor surfacing Binding surface* (adhesive) flMng earner* tfet FlatMbastoe equipment* bunding oeatant*)* & roofing tor txKiosng*. WaHHntog* in buddings. Siting * roofing on bufidiRQ*. Component* of automotive A printing Friction component*-- B8ter-atttr ~~ gasket*. Brake Mocks. to dissipate heat when gears are change*_______ to provkto nonteaking joints. To provide protection against heal * wear carted by braking in Material in safely curtains, fire blankets. & safety clothing. Friction materials itrnanmsarontsusarlORs. Commer*! paper... Genera) insulation paper & muffler Disc brake pad* (heavy voftfctec^ DM teak# pad* v(feighhict*Mme*** Components < brakes in I - veNctaa .Componantpfit medbmWiictofl. bratoes in gM*'' medtem vehiefe*. Materials that - - support braking SkiMawNadMutAoroMuaM- mxtuniamm- twtt. con-own, moTstura. Table v--Summary Table of Asbestos Asbestos automatic transmission Products, Their Major Uses, and the friction components are currently being Extent to Which They Can be Substitut replaced with cellulose-based friction ed--Continued components. Only one of three domestic Aabwto* producl Major oaa* Extern to wtsch "sssr Tflpteco aabeetoe produua 1 manufacturers of clutch facings makes them using asbestos. Clutch facings made of fiberglass and textile fibers have begun to replace asbestos facings Dttheiy Pwtefly to a significant extent However, these substitutes are inferior to the asbestos Adb--to* p*ridng.~ To Mat fluid*.In a#pfci*ma wh*r* motion takss piece. Paints 4 ftxfaoe Protect surface* coatfog*. from oorrosion A water. Surface* )t clutch facingsin durability, quietness, and tensile strength. Product, development is continuing, however, to X improve fiberglass facings to increase strength, wear, and ability to withstand include chimney*, tank*. Pfm. ppfranco* Plpolww wrap ........ Wraps for gas, oil. riot water. * steam p**ng; pnmarty underground. RoNbooTO_________ Protection against fire, heat corroeton * moisture in X heat through the use of special binders. Aramid-fiber-based clutch facings are also being developed. However, these X have been relatively expensive compared to the asbestos and fiberglass clutch facings. / Semi-metallic disc brake pads have . largely replaced asbestos disc brake pads in domestic cars with front wheel industnat* office equipment fi resalem*) item*. Sheaf gasketing.___ Material u**d to sete fluid*. Specialty popera.--. Fitters to purify or drive.Currently, aboutaspnreent of new domestic cars have front wheel drive and are equipped with sendX metllllclfont disc nada. Also. a~5umber X of brake manufacturers have beyan ta clarify Squid*; coding tower tilt; introduce! & daphragm* for ctectrotytio Textiles--thread yam lap. roving, cefis. Insulation far wiring * cor*.* wtek. lecnic*! conductor*; reinforcement for disc brakes. Manufacturers have reported problems in processing far plastics; insulation for tools, packings, - nonasbestos fibers and problems to meeting standards of durability and heat seal*. & tape. Total numbor..- ...............................- 13 T0 resistance. There has been limited progress to date. One automobile manufacturer has reported that its- new The following examples illustrate the minivans are equipped with semi- - types of substitutes available for those metallic drum brake linings and one _ asbestos products EPA proposes to ban, brake manufacturer has begun either in this proposal or in one of the 3 marketing aramid fiber-basedTiningg for regulatory alternatives described in this the replacement brake market. In proposed rule, including the category of addition, one automobile manufacturer asbestos construction products and the has rppnrfod progrw inrWolnpinff g: category of asbestos friction products. A nonasbestos drum hrake lining using an more complete analysis can be found in aramid fiber. However, domestic car the Regulatory Impact Analysis (R1A) manufacturers have not begun instellmg (Ref. 3). U-- aramid-based or serai-metallic-based- a. Friction products. Substitutes exist drum brakes linings on new vehicles 'or are being developed for almost all uses of asbestos in friction products. except in very limited applications. A number of other substitute fibers are Replacement of asbestos in frictionproducts has been more difficult than in have potential as a substitute for the other asbestos product categories V-^agbeatos to brakes. because of the unique combination of b. Asbestos cloth products. Asbestos physical properties of asbestos which cloth has been used as a final product in make it so well suited Tot friction safety curtains, fire blankets, protective products, e.g., heat resistance, cqmraien clothing, andhigh-temperature conveyor resistance, high tensile streiqgthr thermal belts. Asbestos doth is used as arrinput stability, and processability. However, product in gasket*, packing, friction- substitutes which are nearly as cost* - - - materials, and thernrelandetectrteak' effective as aabestosproducts.havF- insulation. been developed for most uses of - . - There currentlyare a numbs*of, asbestos in friction products. substitute fibers for asbestoeuse to, ~ HWBUI0001303 3748- Federal Register / Vol. 51, No. 19 / Wednesday, January 29, 1988 / Proposed Rules cloth. These Include glass fibers, somewhat (ess suitable than those noted ceramic fibers, carbon fibers, organic above. These include various plastic and fibers, quartz fibers and cotton fibers. vitrified day pipes. Replacement fibers for asbestos in cloth All of the substitutes considered are uses depend upon the specific well established in the pipe market and application. can he joined to or replaced existing Substitutes appear to be available for asbestos-cement pipe sections. almost all bigb-temperature applies tions dL Roofing felt. Asbestos roofing felt is of asbestos doth. If asbestos doth were used For built-up roofing, primarily on not available, EPA expects that the flat roofs. "Built-up" refers to the following substitutes would replace practice of layering felt lengths on top of asbestos cloth as follows; each other with hot roofing tar or Fiberglass doth products: SO to 00 asphalt mopped between layers of percent. adhesion and additional weather Aramid cloth products: 20 to 25 protection. percent Currently. less than 10 percent of Carbon/graphite doth products: 5 to roofing felt sold contains asbestos. 10 percent Organic felt, fibrous glass felt, and Ceramics and silicon-based doth single-ply membrane roofing all have products: 10 to 15 percent greater shares of the fiat roof market Because of their temperature and than asbestos felt. flame resistance, asbestos clothing Of these three well-established products protect wearers from fire and products, fibrous glass felt most closely heat However, substitute products have approximates asbestos roofing felt in been developed for asbestos dothing purchase and installation prices and products. Aramid doth products can service life. Organic felt has a lower substitute for asbestos in protective purchase price, but has lower insulation garments, but are more expensive. Some value and moisture resistance and a other textile products made without somewhat shorter service life. Single-ply asbestos are less expensive than the membrane roofing consists of a laminate counterpart product made with asbestos of a modified bitumen or polymeric cloth. Substitute products for asbestos system such as polyvinyl chloride or dothing include nomex. fiberglass, and zetex. Asbestos dothing has been replaced by substitutes in most or all firefighting and industrial applications. c. Asbestos-cement pipe andfittings. Products in this category are manufactured far 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 conduded 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 sack as carrying water at low pressure. If this rule is promulgated, EPA expects that the following substitutes will replace asbestos-cement pipe as follows: ethylene propylene diene monomer. A typical product consists of a five-layer laminate composed of a thick plastic core protected 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 times that of asbestos felt, is about as expensive to install, but is expected to have a longer service life. Single-ply membrane also has the advantage of not requiring the use of hot asphait during installation. e. Flooringfelt andfelt-backed linyl sheet flooring. Asbestos flooring felt was used as a backing for vinyl sheet flooring products. The felt confers dimensional stability and helps prolong floor life when moisture from below the surface is a problem. EPA does not believe that flooring felt is currently being produced in the U.S. A large number of non-asbestos vinyl flooring products have entered the market in the last 5 years. These products include sheet backed with felt containing fibrous glass, cellulose, polyethylene or polypropylene fibers, ceramic fibers, and plastic foam. Also available are unbacked sheet and Polyvinyl chknide (PVC) pipe--------72 percent numerous traditional flooring products Ductile iron pipe-------------------------------------23percseuncth as ceramic tiles, capering, and Prestreseed concrete pipe_______________ Reinforcedconcrete pipe0.15 percent 4.2percweonot d flooring. Among these many products, consumers wilt find adequate These estimates are only approximate substitutes for any particular use of and da not take into account other asbestos containing felt or felt-backed possible substitutes that EPA considered 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 j mostly attributable to the colors and patterns of the vinyl as well as the wear-layer thickness. f. Vinyl-asbestos floor tile. Vinyl- asbestos floor tile is used in 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 I resins in place of fiber. Many non asbestos 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 fast as long as the asbestos tiles, while others believe service lives will be shorter. EPA currently assumes that 1 service lives of the non-asbestos tiles a will be about one-third shorter than for 9 the asbestos tiles. * g. Asbestos-cement sheet There are a number of cost competitive substitutes for asbestos-cement sheet These include both products using substitute fibers and other product substitutes. Class-reinforced concrete is suitable for " most corrosion and heat-resistant . applications where asbestos-cement sheet is now used. Glass-reinforced concrete is widely available at a price that 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 weather-resistant applications. In the siding market asbestos-cement products have no cost advantage over galvanized steel, aluminum, or concrete. However, asbestos-cement sheet may have greatercorroaion resistance than < the oAer products. In cooling towers, polyvinyl chloride products or ceramic i HWBUI0001304 gtc. ' Federal Register / Voi. St, No. 19 / Wednesday. January 29. 1986 / Proposed- Rules* 3747 tileppoducta ana cost competitive aad a. Fibroua glass appears to be intended as asbestos substitutes may are suitable for most applications. Tharp conaiaerablv less hazardous than wish to discuss their plans with EPA are also 9 number of products that can asbestos based on (lJmorBidity and during a prenotice consultation. Such a substitute for asbestos-cement sheet as mortality studies in workers. (2} in vivo consultation can be arranged by a laboratory desk top and fume hood and in vitro experimental data. (3) the contacting the Prenotice bench,However, it appeerathal. ,, order of inaptitude lower exposure Communications Coordinator by comparablyjuicedptodBclq may not, potential in the workplace, (4) the telephone at (202-382-3745) or by fully match the qualities ofasbestos- generally less respirable nature of the writing to the Prenotice Communications cement sheet in these applications. . airborne fibers, end (5) the less durable Coordinator, Chemical Control Division h. Asb&tfqe-cementshing^a. There nature of the fibers in the lungs. . . (TS-794), Environmental Protection are siAfW#fes|w gsbestpa-cement . . b. Mineral w<wd does not appear to ih- shingfesfof bpmroofing apd sidina., , present tfidsignificant risks that Agency. 401M St, SW,, Washington DCf. 20460. Through a prenoUce consultation, prMxuuSF *>dati&Uas for asbestos dtieabased on (1) limited EPA can Inform potential PMN asbestos-cement roofing shingles are animal data and morbidity and submitters of legal requirements, asphalt-fiberglass composition shingles. mortality studies for workers, and (2) possible EPA health concerns about the cedar wood shingles, and various the lower exposure potential in the substance, and possible test data that synthetic and natural tiles, such as workplace. EPA may believeneceaaary to evaluate Monrayroofing tile and concrete tile. c* Ceramic_nbersdQ not appear to the risk potential of die substance. Asphalt-fiberglass composition shingles present a comparable risk to that of During a prenotice consultation and any cost about half as much as asbestos- asbestos baaed primarily on (1) the PMN review of a new chemical cement shingles in terms of purchase moderate workplace concentrations, substance that is intended as and installation costs but have only . alj" P) the specialized applications substitute for asbestos, EPA will about half the operating life. Cedar which include its encapsulation or consider the relative riskspresented by wood shingles have a slightly greater incorporation into products. asbestos and potentially presented byt cost then asbestos-cement shingles but "-,a.rTMfSrJr.PSg^ . have a greater operating life, probably not a significant health risk the asbestos substitute. EPA willjnake every reasonable effort to provide Substitutes for asbestos-cement based on the (1) use of coatings on the prompt and ctew information shingle siding include wood, wood fibers which may reduce tfieir concerning the likely result of PMN~; shingles, aluminum siding, PVC siding, reapirabihty, and (2) low intrinsic review in view of EPA's policy of 3tucco or concrete block, vinyl, and brick. Aluminum and PVC siding are respirabmty characteristics. e^Aramidfibers appear to present* encouraging teas hazardous substitutes for asbestos. both virtually identical to asbestoscement shingles in terms of price and relattvely Iqwnsk b^ausejheyag basically ngnpsptrahlejifl currently ----- "T-------^LamTMc EffectsofProposedHu/e> durability. Cedar shingle siding is also very competitive in terms of price, but it FnPii, This portion of the preamble prasenteEPA's determination Sf the "reasonably is somewhat less durable. The total substitute market for both applications is approximately as felSv littleto ascertainable economic consequences of relattvely little nsk since they appear to (h ^ required by section- nonresSablenO X1Ca 6(c)(1)(D) of TSCA- ^ follows; g. Attapulgite has large general Asphak/fiberglaea*.............. ............ 50 percent exposure potential but available Wood product....................- 30-35 percent evidence suggests that attapulgite from Dvr^"J,wS,dmg'............ Kn PerCen! U.S. mines may present little hazard. In b^ mT8'..............-............ Ip" addition, attapulgite is not a major Drag, me.;.-....................... a percent substitute for agbeatos. C Z. Passible hazards ofsubstitutes^ h. Polyvinylcholoride does not appear EPA has analyzed available data on the to present 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 itselfpresents and construction products made of brick little risk and workplace exposures are and concrete appear to present little apparently adequately controlled. risk. While other substitutes present . i. Ductile iron pipe does not present a some risk, EPA has concluded that the health hazard comparable to that of available information suggests that none asbestos. of the substitutes appear to present as EPA recognizes that some asbestos great a potential for riaEto hitman substitutes may be new chemicaT health as asbestos. EPA made extensive . substances for which a premanufactura use of the work of theTJitional Research notice (PMN) must be submitted under Council and agrees with their conclusion section 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 development of new chemical considered, including tibroug giassT substances that are less hazardous than attapulgite. and carbon fibers, appears the chemical substances they replace: to be much less than for risk from ~ EPA encourages the development of less asbestos. eapeciallv_chrvaotile'' fRef. 6). hazardous new chemical substances as The conclusions of EPA's analysis of asbestos replacements. Potential specific substitutes follows- developers of new chemical substances EPA has prepares "Regulatory Impact Anaiysia of Controls or Asbestos Products" (Ret 3) which analyzes the potential economic impact f 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 role 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 !is 1 :f HWBUI0001305 Federal / VoL 51. No. 19 / Wednesday, January 2ft 198B / Proposed Rntea asbestos I i constant over tfw tiara period used for mesaursmeRt of costs. Actually, price differentials are likely to decrease over time. Two typesoncosts are estimated in theRiA; |1> Costs to ramsnmpra aad (2) costs to producers. These are discussed below. The costs represent the present value ai losses incurredover the 15-year periodiroB 1965 to 2000. using a discount rate of 10 percent. 1. Consumerlosses doe to the rule would result from increases ht costs inewrodfar asbestos products or substitutes Car asbestos products and fro inferior performance of substitute products Total'consumer lasses due to the misters estimated to be $1.77 billion. However, this loss would be spread across the entire coMorner population and would average less than $10 per consumer over 15 years. This rale would not czuk dramatic cost increases in typical consumer products. 2. Losses would accrue to producers as a result of the rale when producers are farced to forgo some portion of the 'return or* theircapita! stock used to produce asbestos products. Owners of equipment which can be readily converted to make other products are not expected to lose neatly as much as owners of equipment which cannot be easily converted.Total producer costs are estimated to be about $209 million for the rules. 3. In addition, the rule would result in transition costs to workers who are displaced by phasing down production of asbestos products. These tosses are incuned 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 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 coats of the product bans proposed in this rale. These estimates are shown below: PeodBC* A/C PipeST65 4 Msffcrr HRooop Moi-r--o--^--l-a---*-!-N---o-- CSttff*tSeMRbfr Pro*** Asbestos GMwg___ Hoofing ten------- veecNt The above costs of the rale will be offset to some extent by the foltowring avoided costs By reducing the amount ofasbestosrelated deaths and illnesses this rule would reduce the coat 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 LiMM i the avoided morbii cost is about SI.275 per < "nSeasiired in 1985 dollars oSing. 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 tovalue the lose of life itself. In addition, no wahaewa# assigned to "pain and suffering," "tossof leisure tune.*" and other similar losses. Substantial asbestos removal and disposal costs would be avoided as a result of this proposed rule. These include avoided expenses as well as avoided health risks for people exposed during removal and disposal activities. 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 benefit of this proposed regulation. These costs can be substantial. EPA has estimated that removing asbestos from school buildings costs between $2 and $13 per square foot of asbestos removed. OSHA and EPA both have regulations to limit asbestos exposure at work sites. Certain costs related to compliance with these regulations would be avoided as a result of this rule. To comply with OSHA's current workplace standard for asbestos, employers incur expenses related to: a. Monitoring for fibers. b. Providing engineering methods to control exposures (this includes enclosing or isolating asbestos fiber generating activities, providing exhaust ventilation, dust collection, etc.) c. Providing hand tools such as sawa. scorers, drills, and abrasive wheels that have-local exhaust ventilation systems. d. Modifying work practices to reduce exposure. e. Providing special clothing, change rooms, lockers, and special laundering. f. Labeling asbestos material and posting caution signs. g. Providing special procedures for collection and processing of asbestos waste. 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 asbestosrelated 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 ofthis proposed rule on smell 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 smalt 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. HWBUI0001306 Federal Register / VoL 51. No. la / Wednesday, January 29t 1986 / Proposed Rules 3749 However. EPA acknowledges that a higher percentage ofsecondary processors are likely to ha suit businesses than, thepercentage of primary processors that are smalt businesses, ta additJoni 5 ofthe 11 companies that manufacture the products that this role proposes to baa are small businesses. 71113 proposed rote couldhave significant impact on these few companies. The estimatedcosts of the rale could be seen as significant. However, the overall benefits to society ofashestoscontaimng products are diminishing with the current availability and the corrtteoed development ofvarious nanaabestos substitute*. Hie costs of the rule are speculative and probably are eraestimated. So addition, many economic impacts of this rale are likely to be short-term and spread across huge populations with only negligible impact on the typical consumer, this rule fs not expected to cause dramatic price increases in typical consumer products. Consumer losses caused by this rule would he spread across the entire consumer population, Jobe displaced by this rule are likely to be offset by increased employment in companies producing substitutes far asbestos products. Potential consumer and producer costs are likely to be offset by the economic costs avoided by this rule, i.a., avoidance of the morbidity coats 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 aseoeisted with ieggi 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 ussovatioa and encourage the continued rapid development of noaaabestaa. substitute products. This development of new products is likely to involve significant technological innovation. IV. OtterOption* C0n8hfeiP^> Section S of TSCA requires that EPA apply the least burdensome requirements to reduce an unreasonable risETEPA isxansidfirhaga"nuinber of options for implementing the regulatory policy ofphasing out the manufacture and importation of asbestos products. These options involve staged bans of categories of asbeatoa mMUCtsTThia approach would ban the manufacture, importation, and processing of all asbestos products within a certain V 1. Baa the asbestos construction category at the saara dote. EPA is J productfcaiegory and asbestos clothing considering a catenary approach for j soonofferpromulgation ofihe rule, ban grfiupa of asbestos products with srmilaJi the asbe3t&Ffi^todproducts category exposure patterns, kaaitar exposure I about Syears later, andgather control issues, and suedar substitutes. \ additionalutfarmalwiiort other Examples of categories under .--.asbestos productsJJndes tKS consideration are ccnotrectioo product i and friction arodacts. EPA behoves it may bs good public potty to tm categories of products at the same time. This approach would address stmifeur exposure pattern* in the same way and treat all parte ofan industry sector similarly. In addition, both thn construction product* category-and the alternative, EPAwouW ban the manufacture, importation, and processing ef the asbestos constnsetkm product* category (he., asbestos-cement pipe and fittings, roofing felts, flooring felts and fett-backed street flooring; vinyl-asbestos floor tile, corrugated asbestos-cement sheet flat asbestoscement sheet and asbestos-cement shingles] and asbestos clothing soon product* that cotrid anbatitute for otter after promulgation of the rule. Effective substitutes exist far these products. The banned. Thu*, a ban of the entire. rule would alsobon the manufacture, inebriation, and processing of die risk most effectively. OhjTdption under active consideration in addition to the ones embodied in the proppgaTis banning the manufacture, importation, and procasing ofthe asbestos construction products category and asbestos clothing with the twin asbestos friction products category (i,e, drtffiTbrah* linings. disc brake pad* tor light. medium, ana heavy veKkaea. brafiT blocks; clutch lacings, automatic ~ transmission friction cod industrial ana coannerciaiftTction the rale. alternative w/n>llfreriiH-g effective soon after promulgation of the ruleTEaiming the manufacture, importation, and processing ofdie asbestos friction products category about 5 years after promulgation of the rule; and gathering up-to-date production; exposure, and use data on the remaining asbestos products under sectidrTBfa) of YsOa to support possible bans~of other asbestos products at that time. Anotner option is banning the exposure toasbeatoa withouithe administrative burden of EPA ~ esfafilSSinn and operating a permit systeaTis in the proposed approach. Ttns'aitegiaiive. by banning asbestos friction product* & year* after promulgation, would stropglveacoqrage therapuFHevelonment of additional effective substitutes for aabeatogftiction oroductsTThe 5-vear delaved ban would also allow time for expansion nf manufacture, importation, and processing of the asbestos construction products category, asbestos clothing, and-the asbestos friction products category as stated above and banning the remaining asbestos products at a later time {e.g.. to years], thus allowing time for the development of effective substitutes while strongly encouraging substitute development A third option is banning the manufacture, importation, and processing of the asbestos construction products category and asbestos clothing as stated above and covering ail other asbestos products uitdeFthephase-dawn. Under each of the options. EPA is also considmog a production capacity for nea-aabesto* friction products. qPA pfttimatey that this alternative. assuming carrent exposure levels, would. avoid about 2,100 cancer cases that EPA canquantify while coating about S2.ll t ot about 1.01 million per cancer case avoided. because OSHA has proposed lowering the workplace PEL for asbestos to aa. fjcc. EPA jiao-eatiiaaiedjhe_ numbers of cancer care* avoided assuming 9trict compliance with this lower.PEL. Assuming stnrt compliance with an OSHA PEL of 0.2 f/cx. EPA estimate* that this alternative would requirement that products not banned soon after promulgation be labeled aa containing asbestos. billion. million per roarer case avoided, EPA is actively considering these To determine how sensitive the cost options as alternatives to this proposed per cancer case avoided was to the rule and specifically requests comment banning of particular products. EPA on these alternatives. EPA may adopt a conducted a sensitivity analyst*, final rule based closely on one or a excluding asbestos-cement pipe from the combination of these alternatives. These ban. alternatives are discussed more fully Without a ban of asbestos-cement below. pipe and assuming strict compliance 3750 Federal Register / Vol. 51, No. 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 cancer 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 exemptinqjrncess tor essential uses without substitutes. One area EPA is studying in particular is the afterrna'rjkpt forasbestos brakes. Some persons have stated that asbestos brakes now in use it safely De replaced-bv asbestpa- free brakes when they wear out, while others have disagreed with this a~ssertion. Efa is aware of thepotential rislTto the public from poorly performing braKes. EPA specifically requests comment on tins issue. ~ V EPAconsidered 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 ^jj^ducts `category and asbestas^dathina soon after promulgation of the rule. hnn Ihe asbestos friction products category about 5 years later, and ban remaining asbeSlOis products aoaut 10 years later Under this alternative, as in alternative l, 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 .0 years after promulgation of the rule. This alternative would relatively quickly ban a number of asbestos products for which effective substitutes exist white strongly encouraging the rapid development of effective substitutes for other asbestos products. This alternative, unlike alternative 1, avoids the necessity of future rulemakings to gather additional data and then ban additional products. It would also provide greater certainty about the status of all asbestos products and more strongly encourage the development of substitutes for all applications of all products. r As in alternative X ERA is considering Mlfe-'nee'd for an exemption process for asbestos friction products fas connection with the staged orodiint bans. ' EPA estimates that this alternative, assuming current exposure levels, would avoid about 2,120 cancer cases that EPA can quantify while costing about $2.29 billion. This is a cost of about $1.08 million per cancer case avoided. Assuming strict compliance with an OSHA PEL of 0.2 f/cc. EPA estimates that this alternative would avoid about 1,070 cancer cases that EPA can . quantify, while costing about $2.29 billion. This is a cost of about $2.13 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 $2.02 billion. This is a cost of about $2.12 million per cancer case avoided. ( X/Ban the asbestos construction products category and asbestos dothins soon after promulgation of the rule"ind cover all ataer asbestos produces under We phase down, Xjnder this alternative "EPA would ban the manufacture, importation, and processing of the asbestos construction products category and asbestos clothing soon after the promulgation of the rule and cover all other asbestos products under the phase-down. This alternative, unlike the current proposal, would ban all asbestoscement products at the same time, thus addressing similar exposure patterns in the same way and treating all parts of an industry sector similarly. The phasedown would operate to restrict use of asbestos in other industry sectors. EPA estimates that this alternative, assuming current exposure levels, would avoid about 2.020 cancer cases that EPA can quantify while costing about $2.01 billion. This is a cost of about $1.00 million per cancer case avoided. Assuming strict compliance with an OSHA PEL of 0.2 f/cc. EPA estimates that this alternative would avoid about 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 ano Cancer Cases Avoided Pro posal ML t Alt 2 AIL 3 Assuming Current Exposures Cost (btfiions)........................ Cancer cases avoided......... Cost per cancer case avoided (millions).............. Si 98 1,930 SI.02 $2.11 2.100 $1.01 $2.29 2.120 si.oe S2.01 2.020 $1.00 Assuming Strict Compliance With an OSHA PEL of G-2f/cc Cost (tuitions)........................ Cancer cases avoided........ . Cost pef cancer case avowed (mtHtons).............. Si 50 { 1.000 SI .99 S2.1t 1.06Q $2.00 S2.29 1.070 $2.13 $201 1.010 $198 Alternative f--Ban asbestos construction pcorJucte and asbestos cfottwng soon after promulgation and ban asbestos nation products m five years. Alternative 2--Ban asbestos construction products and asbestos clothing soon after promulgation, ban asbestos fretion products m five years and ban remaining products n ten years. Atternanve 3_0an asbestos construction products and asbestos clotfuog soon after promulgation and cover romanv products unoor the pnase*dcwn. 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 CQt-immediatel7MaSeT~ 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: (2J 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. EA also considered a number of alternatives for implementing the phasedown. These include options concerning thelollowing: who would be assigned permits; how persons woul9~tie~gfanted HWBUI0001308 Federal RbgjMer / Vat St, No. 19 f Wednesday, Janaary 29, 1980 / ftofwed Rales 3751 i /c*rO i PAaiaoconaftftred a memberel option* before adopting id current regulatory strategy for eoaHreBfag the risk from mbeatom. These optima are diseased documents which at* included in the rulemaking record. EPA Itn weighed th* health lUs from condonednseof nehestn* and asbestoe-contaming ywdocte agsact die costs attributable to the proposed regulatioa^EPAJiag caccfaded. that the av^danoeefaboat*****-^^ e--g* that can Be quantifiedjmwm; rnmnt exposure level*, ot the 1308 cancer cases t*a* cam h* gaanMtled mnamhm strict cemalianre with an OSHA PEL of 0.2 flee, manyoti cannot he aumitified. and man* cases of asbestea-reSteAdjaamm substantially outweigh the costa to consumers, producers. and aaere of asbestos products from the proposed regulation. therefore. KPA finds that the eontmuetT mining and importation of asbestos, and - asbestos products in the United States for domestic use and for export present an unreasonable nsk to human health fire finding ia 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 heen shown to cause asbestos-related disease. 3. Model* developed to estimate the relative risk of developing cancer from exposure to asbestos show a lineardostMaspoMB relationship. J&Sedon daiafrom epidemiology studies, these models predict that humans exposed to very low levels of asbesto* incur some risk Individuals frequently exposed to level* typical}? found at asbestos worksites are estimated to have very high risks of contracting cancer, perhaps greater than 1 in 100. 4. Asbestos fibers are colorie**. odorless, and frequently invisible, thus presenting rhric to persons not aware that they may be exposed Asbesto* fibers are extremely durable and have aerodynamic properties that allow diem to remain suspended in the air for a long time. Asbestos fibers easily reenter the atmosphere after settling out and can travel tong (balance* through the ait 5. Health risks from exposure to asbestos Fibers during the lifecycle of the asbestos product* covered by this groooiednife nrciir ta-imny population groups during many activities. Persons can be exposed to asbestos fibers long after those fibers have been released to the air and at a considerable distance from the source of release. The vast majority of the general papulation of the U.S. is exposed to asbestos in the air. More than 40J30Q workers are exposed during manufacture and processing of asbestos products covered by this proptsSat"Many additional thousands of workers and consumers are exposed maintenance, renovation, removal, and many-nritttsfia of people woo reside near asbestog'woiksitea are also exposed to significant concentratkmsof asbestos in the air. 6. Using typical, rather than worstcase, data and assumptions. EPA has estimated that this proposed rule banning certain asbestos products and phasing out all others, if promulgated, would avoid approximately 1330 case* of cancer which would otherwise result from exposure to asbestos between the years 1935 to 2000. EPA underestimated the number of cancer cases avoided because of the lack of comprehensive data on releases of asbestos to the ambient air from many activities. EPA estimates that the following numbers of cancer cases would be avoided as a result of the proposed product bans, assuming both current exposure levels and strict compliance with an OSHA PEL of 0.2 f/ec. Cancer cases These estimates of cancer cases avoided by the product bans should not be viewed in isolation, since asbestos use in other product sectors would theoretically decrease at less than the current rate unless all asbestos use is phased out. 7. Even if OSHA promulgates and achieves strict compliance with a PEL of 0.Z tfcc. almost 1,325 cancers would still result front asbestos products made over the next 15 yean. This rule would avoid about 1.009 of those cancer cases. 8. The estimated costs of this proposetimle arereaaonkble 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 became available during the phase-down period for most, if not alL other uses. Even though the costs are probably overestimated, the coat per cancer cane avoided, assuming quantify, is about S1-Q2 million. Even if OSHA promulgates and achieves strict compliance with a PEL of<12 f/cc. the coat per ranrar avoided that EPA cS5 quantify without &L99 million. If all cancer cases andThe 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 papulation sa that the cost to any individual wonid be negligible Further. EPA expects substantial savings to result from this rude 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 cost* resulting from asbestos disease claims. EPA also finds that tbe costs of alternatives 1.2. and 3 are reasonable in view of the numbers of cancers and other adverse health effect* that they would avoid. The costs per cancer caseavoided that EPA can quantify of these alternatives are approximately tbe same as for the proposed rale. As discussed earlier. EPA conducted a sensitivity analysis to see bow 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 Boor tile from the bans. Even with these relatively high exposure products excluded from die 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 {fee. this proposed rule would cost about $1.90 million per cancer case avoided that EPA can quantify. Without a ban of vinyf-asbesto* Soar tile and assuming strict compliance with an OSHA PEL of 0.2 tfcc. this proposed rule 3752 Federal Register / VoL 51, No. 19 / Wednesday, January 29, 1986 / Proposed Rules would cost about $2.28 million per during the disposal of asbestos and cancer case avoided that EPA can asbestos products.________ _ quantify. VII. Analysis Under Section 9(a) CVI. Other EPA Statutes Section 8(c) ofTSCA requires that if TSCA ___________ ____ 3 Under section 9(a)(1) of TSCA. the EPA determines that a risk of injury to Administrator is required to submit a health or the environment could be report to another Federal agency when eliminated or reduced to a sufficient two determinations are made. The first extent by actions taken under another determination is that the Administrator statute administered by EPA. EPA may has reasonable basis to conclude that a not promulgate a rule under section 6(a) chemical substance or mixture presents of TSCA unless EPA finds it is in the or will present an unreasonable risk of public interest to protect against the risk injury to health or the environment. The by action under "USCA EPA finds that second determination is that the no other law administered by EPA will unreasonable risk may be prevented or eliminate or reduce the risks from reduced to a sufficient extent by action asbestos to a sufficient extent. taken by another Federal agency under Several EPA statutes have been used a Federal law not administered by EPA. to limit asbestos exposure. In 1973, EPA Section 9(a)(1) provides that where the used the authority of the CAA to list Administrator makes these two asbestos as a hazardous air pollutant, determinations, EPA must provide an establish a "no visible" emission opportunity to the other Federal agency standard for manufacturers, and ban the to assess the risk described in the use of spray-applied asbestos- report, to interpret its own statutory containing material as insulation in authorities, and to initiate an action buildings, published in the Federal under the Federal laws that it Register of April 8,1973 (38 FR 8826). administers. Section 9(a) of TSCA thus EPA amended this regulation in 1975 to requires EPA to review other Federal ban asbestos-containing pipe tagging, by authorities not administered by EPA to a rule published in the Federal Register determine whether action under those of October 12,1975 (40 FR 48292); and in authorities may prevent or sufficiently 1973, extended the ban to all uses of reduce unreasonable risk. The following sprayed-on asbestos by a rule published unit summarizes past and contemplated in the Federal Register of June 19.1978 action by other agencies and then (43 FR 26372). The CAA rule, which was discusses why those agencies are not last amended on April 5,1984 (49 FR able to prevent or sufficiently reduce the 13658), also regulates the removal of unreasonable risk presented hy asbestos from buildings and the disposal asbestos. of wastes generated by removal. However, the CAA has limitations. .1. Other Authorities Affecting Asbestos The CAA does not apply directly to Under the authority of the Consumer indoor air in the workplace or home. Product Safety Act (CPSA, 15 U.S.C. Consequently, any possible additional 2051) the CPSC has issued rules banning use of that statute may leave many consumer patching compounds workplace or home exposure situations containing respirable asbestos (10 CFR inadequately controlled. Part 1304) and artificial emberizing Another EPA statute that could be materials containing respirable asbestos used to limit asbestos exposure is the (10 CTR Part 1305). The CPSC took those Safe Drinking Water Act (SDWA). EPA actions based on findings that the use of announced its intention to consider those products in the household would asbestos for inclusion in its proposed result in increased risk of cancer. National Revised Primary Drinking Earlier, the Food and Drug Water Regulations by a Notice Administration under the Federal published in the Federal Register of Hazardous Substances Act (FHSA. 15 October 5,1983 (48FR 45502). However, U.S.C. 1261) banned "general-use even if the SDWA is used to set a garments containing asbestos other than drinking water standard for asbestos, it garments having a bona fide application would necessarily ignore the inhalation for personal protection against thermal risk associated with asbestos. - injury and so constructed that the An additional EPA statute that could asbestos fibers will not become airborne be used to limit asbestos exposure is the under reasonably foreseeable conditions Resource Conservation and Recovery of use" (16 CFR 1500.17). The FHSA is Act (RCRA). Under RCRA. EPA could now administered by the CPSC. list asbestos as a hazardous waste and In 1980. CPSC issued a general order subject asbestos waste to general RCRA requiring persons to furnish information requirements designed to reduce on the use of asbestos in certain exposure. However, such action under consumer product categories. CPSC has RCRA would only reduce exposure also 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 14116). 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 of2f/ec. Possible jurisdiction over other aspects of asbestos risk may lie with still other Federal agencies. For example, the AsbeBtos Information Association (ALA), 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 iha 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 *o 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 i s HWBUI0001310 Federal Registar / Volt 51. No. 19 / Wednesday. January 29, 1986 / Proposed Rules. 3753 reduced to a sufficient extent by actions there is no other Federal authority /'a. Hesiduafrisks^Even if other taken under a Federal law not capable of addressing the combination Federafagencies took additional action administered by EPA. Certain activitian of activities involving asbestos. Section to reduce the risk associated with involving asbestos present risks that faO 9(a) requires EPA to consider the issues asbestos during the various stages of the under the jurisdiction of a number of necessary to make this determination lifecycle of asbestos products clearly different Federal law such the because the Agency believes that the within their jurisdiction, a substantial OSHAct H< rnnmimee-Prnthict Safety. combination of asbestos activities, and unreasonable residualTTsk would Act and the Clean Air Act but no one, under the.jurisdiction of a number of still remain. statute, other than TSCA. can __ Federal laws, presents an unreasonable Many groups outside of OSHA adequately address allita risks. Referral risk. Second. EPA examines the residual jurisdiction are at risk from exposure to r~' would result in fragmenfecHtssessment ofrisks and potentially nupucauve risks that would remain if other agencies asbestos. State and local public were to regulate asbestos and employees, such as firefighters, are not regulatory efforts WfiriMtfrruMitwii of determines that such residual risks protected by OSHA regulations in about riskyandan adverse effect on public- - would still be unreasonable. half the States. The general population health, tmrtflermore. even if EPA were to 2. Capability ofother Federal is exposed to asbestos m the ambienfair refer asheatne. risks to other agencies, niithoritifxr tn riaaLnnth the pnmBinatioit as aresult ot release during flie action takenbv those other i ofasbestos activities. EPA has manufacture, processing, use. repair, wmilrt still l^ffiue substantial residual Concluded that asbestos is a clear and disposal of asUgstonproducts. EPA riak-lIPA's reasons for reaching this example for TSCA action rather than estimates that about 5HTBgrsons will conctnsioh are set forth below. referral to other agencies. It is a develop cancer as a result of exposure " 1. Interpretation ofsection Sfal of substance for which there is broad to asbestos in the ambient air as a result TSCA. The comprehensive nature of exposure to populations in numerous of releases associated with products TSCA has long been recognized. TSCA situations--in the workplace, through impoHetTor manufactured over the next allows regulation of a chemical ambient concentrations, and from 15jrears. substance based on all its risks and, consumer products. With the exception Even if OSHA promulgates and thereby, allows the Government to of TSCA, there is no one unified __ achieves strict compliance with a PEE of remedy the deficiencies in other statutes authority to deafwith these multiple 0.2 f/cc, a substantial and unreasonable that can deal only with parts of the risk. exposures. No one of the other potential residual risk would remain. About 1,325 (Statement of the President on signing S. Federal regulatory authorities, in looking persons would still develop cancer as a 3149 Into Law, October 12,1976, Weekly at its specific part of-the overall result of exposure to asbestos in Compilation of Presidential Documents. exposures, can either evaluate or deal products imparted or manufactured over voL 12. No. 42, Oct 18.1976. at 148% & with the totality of the risk presented.. the next 15 years. These include cancers Rep. No. 94-698,94th Cong., 2d Sess. at Thus. OSHA may set exposure limits for. in populations totally outside of OSHA's 2.) The need for a total exposure workers, but there may be venting of jurisdiction Even with a lower approach to chemical regulation and the asbestos into the atmosphere; EPA, workplace PEL. EPA estimates that dangers of a fragmented regulatory under the Clean Air Act, may regulate about 540 persons will develop cancer approach were recognized even during ambient emissions, but not workplace or from exposure to asbestos in the the early congressional hearings on consumer exposures; and in each step of ambient air. In addition, at a PEL of0.2 TSCA. See, e.g. 1973 Senate Hearings at the process, only a fraction of the risk is f/cc. EPA estimates that about 785 212-21% 1972 House Hearings at 65-87. evaluated. Only EPA under TSCA may workers under OSHA jurisdiction would No other single law provides authority look across the range of asbestos use to develop cancer as a result of workplace to deal comprehensively with multi- evaluate whether it presents an exposure to asbestos in products media hazards. unreasonable risk. There is no other Act imported or manufactured in the next 15 In particular, Congress designed that affords such authority and, years. TSCA to deal with chemical substances accordingly, referral is inappropriate. EPA calculated these figures using for which the most appropriate remedy EPA's analysis of the jurisdiction over well-accepted models. EPA used the would be a total ban on their production the risks presented by asbestos among a Nicholson relative risk model to and distribution in commerce. lathis number of agencies and statutory estimate the number of lung cancer regard. Congress focused on the risk of authorities is set out below. OSHA has cases and the Nicholson absolute risk asbestos and the dangers of fragmented authority under the OSHAct for risk model to estimate the number of regulation of asbestos during the presented to private sector mesothelioma cases. The dose-response legislative hearings. See 1971 Senate manufacturing, construction; and service constants used in the risk assessment, Hearings and 1975Hearings. Asbestos employees from workplace exposures, were those estimated by Selikoff in a risktrwere'1describedin the workplace and may approve State plans covering study of asbestos insulation workers and inover 3,090 uses that,could present State and local public employees. CPSC (Ref. 11). A number of epidemiological risksto thegeneralpopulation. (H.R. has authority under the CPSA and' studies have estimated dose-response Rep. No. 94-1341,94th Cong., 2d Sess.. at FHSA concerning risk presented to constants for asbestos-related diseases 5 (1978).) Members of Congress believed consumers from consumer products. The and estimates vary by as much as an it intolerable that no agency could deal Mine Safety and Health Administration order of magnitude. The Selikoff comprehensively with chemical risks, has authority under the Mine Safety and estimates fall approximately in the including the risk from asbestos. See Health Act concerning risk presented middle of the ranges of dose-response 1973 Senate Hearings at 319-320 (Letter during the mining and milling of estimates for both lung cancer and from Senator Tunney to Dow Chemical asbestos. State and local public mesothelioma. In addition, the Selikoff Company); 1975 Senate Hearings at 131- employees, such as firefighters who. may estimates have the lowest variance 133 (Remarks of Senator Tunney). wear asbestos clothing, in about half the among all of the estimates. These EPA's decision not to refer the risks States are not covered even indirectly models and dose response constants associated With asbestos is divided into by OSHA regulations and are subject to were recommended by the CPSC'a two parts. First, EPA determines that State authority. Chronic Hazard Advisory Panel on HWBUI0001311 33E / VtA 51, No. ia / Wednesday, January 23,1306 / Proposed Rales asbestos (Ret 1) and were also used by OSKA toestimate therisk posed byasbestos krsupportof dieproposed revision of OSHA's asbestos standard. OSHA's choice of02 f/cc ss a proposed PEL was based on the feasibility afmeasemgasbettw levels in the workplace. At a level of,0.2 f/cc. OSHA, using the sane lung cancer and racsatfceliaHM models as EPA, estimates that there would be 078- excess cancer deaths per 100,008 workers exposed over a working career (Rei 12}. In 1330. a joint IttOSH/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 measeing air concentrations of asbestos (SeL 7). Even a level of 0.1 ifcc. OSHA estimates that there could be 330 excess cancer deaths per 100,000 workers exposed over a working career (Ref. 12).. It is likely that a PEL of0.2 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 ofworkers 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 m the construction and service sectors since employees frequently do not have a fixed worksite. In feet, 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 die release - of large quantities of asbestos to the ambient environment, where if continues to present a risk both to other workers and the general population. Similarly, CPSC cannot evaluate or deal wife the totality of the risk presented by asbestos. CPSC may ban or require safety standards for asbestoscontaining consumer products based exclusivelyon risk to consumers. CPSC is unable to consider risk to other groups from releases of asbestos during the lifecycle of those prostata. After carefully analyzing other Federal authorities, EPA coadudes that actionunder TSCA is appropriate to reduce the unreasonable risk to human health posed by asbestos. Use of other Federal authorities cannot reduce risk to a reasonable level because (2) they cannot reduce the total volume of asbestos in commerce, (2) they cannot protect the many population groups at risk, and (3) they all have jurisdictional gaps. Vin. Provisions ofthe Proposed Rule A. Product Prohibitions EPA proposes to prohibit the manufacture, importation, and processing of several asbestos products. The prohibitions will take effect at (fire same time that the restrictions on the mining and importation of all asbestos and asbestos products become effective. Thus, when this rule becomes operational, no person could mine or import asbestos without a permit issued by EPA. In addition, no person conld manufacture, import, or process the following asbestos containing products: Asbestos cement pipe and fittings, roofing felts, flooring felts (and feltbacked sheet flooring], vinyl-asbestos floor tile, and asbestos clothing. EPA is proposing to ban asbestos clothing because it presents a particularly serious risk because of high exposure potential, EPA is proposing to ban the other products because effective substitutes are currently available for aif applications. As an alternative, EPA is considering harming these several asbestos products by a date soonafier the promulgation of this rule. B. Mining and Import Restrictions EPA proposes to prohibit the mining or importation of bulk asbestos, and the importation of the asbestos products listed in 7B3.145 of the proposal, unless issued by EPA allowing mining or importation of that quantity of asbestos. EWtlicOTsid^tegthelequiiiCTientthir products made under fee permitting system be labeled as containing asbestos. Labeling would ensure that persons working with or otherwise handling the products would know that the products contained asbestos, and it would enable them to take steps to reduce the likelihood of exposure. EPA proposes to reduce the amount of aahestoa that may be imported or mined in set decrements each rear for 10 years. EPA proposes to define "mine" as "to produce asbestos other than as an unintended contaminant or impurity by extracting asbestos-containing ore so that the are may be (1) distributed in commerce or (2) milled for distribution in commerce.'' Thus, the unintentional mining of asbestos in connection with mining of another substance such as vermiculite would not be coveted by this proposal unless fee asbestos were later milled or sold for use. EPA is concerned about possible unintended asbestos contamination of vermiculite and other minerals. However, any attempt to cover the unintentional mining of asbestos under this rule would complicate fee 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 fee United States for expert 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 fastness activities involving use of fee product." Thus, asbestos that is shipped through fee United States far export withoutrany domestic processing or use would not be covered by this proposed rate. The proposed rale also excludes from coverage rifeationa where an item, such as an automobile containing asbestos. travels across fee Untied States border iruhe coursfe of normal persocat or business activities. In emnnariTSiEestos contained in products that are imported in small quantities solely for personal use by ecjpsumers would not be covered by the proposal. Thus, under this provision an indrviduai could bring an item such as a cnnsKioer appliance containing asbestos into fee United States for his or her awn use without obtaining a permit. EPA believes that any attempt to cover feeze situations would make this rule very complex and difficult to administer. However. EPA whefeer. in view rf the gerirem health hazard posed by asbestos, all asbestos products should be coveretTBy this rule.' This proposal covers mining and importation of asbestos and the importation of specific asbestos products. EPA proposes to define "asbestos" as "the asbestiform varieties of: chrysotife (serpentine); crccidohte (rieheckite); amosite (euuimingtonitegrunerite); tremoiite; antbophydite, and actinolita that are mined or milted.** EPA requests comment on this defimtiqriT ' including whetherasbestgiwhkbhas been chemically treated or altered should be included within the-definition. EPA also proposes to cover under fern , pliaae-oown the asbestos contained in j numberotprocfactstistadin &783.145of I HWBUI0001312 Federal Kegtstge/ Vol- 51. No. lfr / Wednesday, January 29, I960 / Proposed Rules 3755 produots. EPA is covering these Persona would apply to EPA for mine asbestos in any quantity fpd particular products In`this proposal permits, listing in tneir applicationslheir would naveno value of any hind for any because they represent the largest mining or import volumes during those purpose. quantities of asbestos imported as part years. Persons who do not apply lor of products. EPA is proposing to cover pgrHntsTwouTtfiiot be granted any. EPA asbestos in products because of the risk would compare volume information posed by possible asbestos exposure . included m applications with during use and disposal of the products pfifonnaticm reported under the section and to treat domestic producers and . 8fai asoestos reporting rule, which importers or tnese productsjimilariy. covered 1881. United States Customs To implement this program, EPA is Service daia. and Bureau of Mines data. proposing that importers of listed Persons who include false information products estimate the typical asbestos in their application would be subject to contentof theproducts. To aid those enforcement action, including criminal estimates. EPA has ascertained the prosecution in appropriate cases. 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. EPA would similarly cover i>pni+rff of asbestos contained in the products listed in this rule. Those persons would apply for permitaJncluding in their application the total amount of asbestos in tHeirimported products during the base years 1381.1882. and 1983. Those Persons could use EPA's estimates of typical asbestos content of products if they do not know the typical asbestos content of their product. The proposal contains an appeals procedure for persons who disagree with EPA'a allocation of permits to them. However, since the proposed rule would allocate each miner and importer a uniform percentage of their base volume levels, EPA would expect few appeals. The only issue in an appeal would be whether EPA allocated C. Permits to Mine or Import Asbestos permits based on the correct base years' EPA is considering an alternative of Chiving 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 wtralcTBe banned pyrept that allowed under an exemption procedure. EPA would uunsider 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 muung and importation after the 10-year phase-down period, itiis general approach would avoid the potentially heavy administrative burdeftatfcl expense of an exemption process. As- conaidering allowing permitalianked during the lO-veaFphaae^downperibd to continue to be used during me later EPA proposes to issue current miners volume information. artere of asbestos permits thai persons would be allowed to transfer . would allow those persons to mine or i t tnlieir pnermmiissssiioonntlo'mine or impornt import set amount8~of asbestos. The --asbestos to other per8ons7including penddwBetiBlnuch afrnaller percentage of base years volume is permitted. Such an'approach would provideadditional incentive for the banking ofpermits antf pgfHnTwouid be letters from EPA stating'v Persons who were not issued permits by thus additional incentive for greater ~ le amount or is EpA- Permits issued to miners, importers reductions in asbestos mining and may import or mine during each year of of bulk asbestos, and importers of importation during early years of the - the TOyiarphase-down period. The asbestos in products would be phase-down period. "permitted" amount of mining or interchangeable. Persons could transfer EPA specifically requests comment on importationwouldbe a uniform perceniage~of the average amount of alfor only part of tneir yearly permitted' this series of alternatives to a ban with amount to one person or a number of an exemption process after thelO-yaar -.Sbestos each person mined or imported oftheir perobdted amornitwould be*"*" " phase-down period. early daring the base period of 1981, 98Z. and 1983. The "permitted" amount required to report each transfer to EPA of asbestos would be 30 percent of the j Persons would also be allowed to person's average base year volumes ~;rve or "bank" permisisonto import report the amount of asbestos imported during the first year of the phase-down asbestos during any year of the phase- dining each import transaction. EM - period and would decline to 27 percent down period for use during any later specifically requests comment on of average base year volumes during the year ot the phase-down period. Persons whether this report should be sent - WSiild he required to report eactT" directly to EPA orwhether persons^ year and so on until it reached~3 percent "banking" of asbestos permits to EPA. A should turn the report over to the United inygflr.inTKPA chose these "permitted" person who hanksoemussion to mute or States Customs Service, which would amounts based on projections of future Im_po_rt_a__i _____ _______ _ forward the report to EPA. Requiring the asbestos use after analysis of current .T/wouIdhe allowed to hub only part of report to be turned over to the Customs use trends, publicly available '^tKaTamount during later years of the Service as part of each import.' information an asbestos use. and phase-down period. The amount of transaction may facilitate enforcement information reported under the section asbestos mining or importation of the rule. -` 8(aj asbestos reporting rule. In addition. permitted by banked permits would The proposal also would require the "permitted" amounts chosen reflect -Jjt-decline veariv at a rate of in percent persons to report to EPA each transfer the EPA has proposed to ban certain v Permits pot used hv the nnnrlnsinn nf of permission to mine or import high volume uses of asbestos where the 10-year phase-down period would no asbestos. This reporting would be under suitable substitute products are avilable. loligirpermit the holder to import or authority of section 8(aj ofTSCA and HWBUI0001313 would apply toU importers. i reporting ia certemoMW. Bawemtt. EffA May require biukes and unportera of a suboteoee subject to a ltd* uadefi 8 of TSCA to report Since asbestos is already subject to rules under section a and would be subject to this one. the small baaiaeas exemption of section Mat would not apply. KMTTelievea that requirements represent very little burden and are necessary for effective enforcement of the phase-down rule. EPA wouid 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 compered 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 ia permitted to mine or import and take appropriate enforcement action for any violation of the phase-dawn rule. To facilitate the transfer nfpermits. EBffe considermgtoSiring readily_ available to interested parties information conceminathe persona 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 ail transfers of permission to mine or import asbestos and the amount of asbestos mined or imported1 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 6 of TSCA Therefore, any failure to comply with this proposed rule when it becomes effective wouid be a violation of section 15 of TSCA. In addition, section 15 of TSCA makes it unlawful for any person to: (if Fail or refuse to establish and maintain records as required by this rufet (2) Util or refuse to permit access to orcopying of records, as required by TSCA; or (3} hail or refuse topermit entry or inspection as required by section 11 of TSCA. Violator* msy be subject to both civil and criminal Kabilily. Under the penalty provision ofsection IB of TSCA, wry person ucW violates section 15 coukf be subject to a dvd penalty of up te $35,000 for each uiuteiioa. Each day of operation in violatins ofthis rule when it becomes effective amidconstitute a separata violation. Knowing or willful violation* of this role when it becomes effective could lead to the imposition of criminal penalties of up to $25,008 far each day at violation and imprisonment for up to 1 year. In addition, other remedies are available to EPA under section* 7 and 17 of TSCA. such as seeking an injoctiem to restrain violations of this rate when it become* effective and seizing any chemical substance e* mixture manufactured or imparted in violation of this rule when it becomes effective. Individuals, as well as corporations, could he subject to enforcement actions. Sections 15 and 18 of TSCA apply to "any person" who> violates various' provisions of TSCA EPA may. at its discretion, proceed against individuals as well as companies. In particular. EPA may proceed against individuals who report false information or cause it to be reported. X. Confidentiality A person may assert a claim of confidentiality for any information, including public comments, submitted to EPA in connection with this proposed rule or 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 submitted to EPA. Persons would claim information confidential by circling, bracketing, or underlining it and marking it with "CONFIDENTIAL" or some other appropriate designation EPA will disclose information subject to a claim of confidentiality only to the extent permitted by section 14 of TSCA and 40 CFR Part 2. Subpart B. 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. XI. Rulemaking Record EPA has established a record for this rulei/'aking (docket control number OPTS--82040). A public version of the record, without any confidential business information, is available in the Office ofToxic Substances Public Information Office, from 3 tun. to 4 p.nx, Monday through Friday, except legal holidays. The Public Information Office is located in Rm. E-107,401M St,, SW.. Washington. HC. Theresold include* information considered by EPA ia developing this proposed rule. EPA will supplement the record with additional iafarmation as it is received. The record now includes the following categories of information: (1) Federal Register notice* (2) support documents, j3j reports, and (4j memoranda and letters. EPA wiM identify the complete rulemafeiag record by date of proHuIgttian. EPA will accept additional material fartoctamen in the* record at any time between this notice and designation at the complete record. The final rule will also permit persons to point oat amf errors or omissions in the record. XU References (11U8CPSC- Report to the U.S. Consumer Product Safety Cmnmksioa by the Chronic. Hazard Advisory Panel on Asbestos, July 1983. (21USEPA OPTS. OTS, Exposure Assessment forAsbestos. Draft January 9. 1984. (3) USEPA OPTS, OTS. Regulatory Impact Analysis of Controls on Asbestos and Asbestos Products. January 1988. (4) USEPA OPTS, OTS. Support Document for Final Rub on Friable Asbestos-Containing Materials in School Building*--Health Effects and Magnitude at Exposure January. 1982. (5) National Research Council. "Asbestos" In: "Drinking Water and Health." Vo). 3. National Academy Press. Washington. D.C. (1982): 223-283. (6) National Research Council. "Nonoccupational Health Risks of Asbestrform Fibers." National Academy Press. Washington. D.C. (1984). (7) NIOSH-OSHA Asbestos Work Group. Workplace Exposure to Asbestos: "Review and Recommendations"' DHHS (NIOSH) Publication No-81-108. U.S. Government Printing Office. Washington. D.C. 20402. (1980). (8) OSHA. "Quantitative Risk Analysis for Asbestos-Related Cancers: A Preliminary Report." (1903). (9) Seidman. H. Selikoff, I.J.. Hammond. E.C.. "Short-Term Asbestos Work Exposure and Long-Term Observation." Annals of the New York Academy ofScience. 330 (1979): 61-89. 110) Selikoff. I.)- Anderson. K.A.. Seidman. H. "Asbestos Disease Among Household Contacts of Asbestos Workers" Ire "Disability Compensation for AsbestosAssociated Disease ia die U.S,'' edited by I.). Selikoff. Environmental Sciences Laboratory. Mount Sinai School of Medicine of the City University ofMew York. (1902): 73-76. HWBUI0001314 FsAyrdMagntar / SI. No. 18 / Wednesday. Janaary 29, 1886 / Proposed Roles 3757 UO&UwS. 1^. Hharad. BXX SaUnan Date January 22.1908. during normal personal or business H~ "MamUla Bsparisnoasf iasutatim LeaM. Hama* activities involving use of the product Waritmin tfe UA rodCanada. M-18" Annals ofthe New York AcademjafSstewx. 330 (1879): 8t-m. (12)03001, QSHA."Ocmo^M--t EmoainB Br--B**1*? Tgwpomry. Standard," (NmtateiIS** 49FRK0SBJ. (131USDOL OSHA. "Occupattoaal Exposure to Asbestos; Proposed HuJa and Nfatfca fHearing." (April 18.1884; 48 FR 14T1BJ: (14) USEPA. OPTS. OTS. Aabaatoa Subatitutes and Related Material*. April 24. 1W XBIqtoairAimnMa! Raqinrsimate A. Executive Oldermst Under Executive Order12291, EPA. has determined that this proposed rule is a "Major Rule" and has developed an RIA. Hie RIA estimates that this proposed rale would cost about SL98 Admmntmtor. PART 70--{Amended) Therefore, it is proposed that 40 CFR Part 763 be amended as fallows: 1. The authority citation Ear Part 703 is revised to read an Sallows: AuthorityISUS.C. 2BB8 sad asrfc). 2. By adding new Subpart H to read as follows: SwPpWi rr^MOttwl wlUnp Klu linpOft Restrictions Sec 7SS.140 Scope. 783L14S. DdMtian*. 763.145 Mininyand import rasMeMtmsc 783-14? Permits to mine crimpsrtasiitatDS. 763.148 tausace of pennita 783.149 AppaalscoBcaniiappefadtB. 783.150 Transfer of permits. 783.151 Banking of permits. 763.153 Recordkeeping (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 me may be (1) distributed in commerce or (2) milled for distribution In commerce. (h) "Miner" means a person who mines asbestos. 763.145 Mining ant! Import restrictions. fa) Beginning the first day of the calendar-year after this ruCTecumea effective, or ifthis.tulaSecamea ' effective (hirina tha last 4 months of a calendar year, hegjnnina the first day of the second calendar year alter this rule becomes effective: no person othee than thUKasw^dbl&Uwlnat MKan avertspeers. However. the RfA alsaestfmsled that this proposed ruta, if promnljgated would avoid approximately inOeases ofcancer. As shown in UnilV ahove; KPA beBeves dial these costs are reasonable and that this proposed action is a cost-effective way of reducing die unreasonable risks related to asbestos. This proposed nrie wan submitted to the Office of Management aad Budget (OMB) far review as required by Executive Order 12291, B. Regulatory Flexibility Act 763.154 Reporting. 783:158 Bnlbicetngit 763.157 Inspections. 783L1581 CosftteotiaiKyand pebMe reesw to Subvert H-Aebeetee lOntasaad Import Restriction* 9763.140 Scope. This Sobpart prohibits the muring or importation of asbestos, incltuitag asbestos in certain asbestos products, unless authorized by a permit tamed by EPA. 763.183 Dcffaraons. mfEeUmtedSfites or (2) Import asbestos, including asbestosin anasbeatoa product listed its this section, except in small quantitiessolely fos personal cnamauwp ma into thecustom* territoryof the Unitad' States (b) Tha fofiewing asbestos products may not be imported into thecustoms territory, of the Untied States except in small quantities by a consumer solely for hisor her personal use miem authorized tat a permit iisoedlar BPA as provided in tta&Sabpart: EWt has analysed the economic The definitions in section 3 of TSCA, (U Appliances. imped of (Me proposed ndn on small 15 U.S.C. 2602, apply to this Subpart In (2) Pipeline wrap. businesses. A msnenwy-of EPA's addition, tha following definitions apply: (3) Thread, yam. lap; roving cord, analysis appears in Unit DL (aj The terms "act" "article," rope, or wide C. Paperwork Redaction Act "byproduct" "customs territory of the United States." "EPA," "importer," (4) Sheet gasketing, rubber encapsulated compressed. The reporting and recordkeeping provisions in thi proposed role wiB be "manufacturer." "persons." and "United /*~(5)n3 brake pads (HgSl-medism ^ States" have the same meanings as in [vehicles).-------------------------------- submitted to die Office of Management 720.3 of this chapter. JgjCloth, other than asbestos clothing. and Budget (OMB) for approval under (b) "Asbestos" means the asbestifotm ([7] Brake BIocR5T> the Paperwork Reduction Act varieties ofc cfarysotile (serpentine); Comments on these requirements should crocidolite (riebeckite): araosita. (8)Mlflbaard. (9) Packing. be submitted to the Office of Information and Regulatory Affairs at OMB and marked Attention: Etesk Officer for EPA. Any frotirale will explain EPA's response to OMB and cJh (cununmgSoaite-grunerite); tremoiits: anthophjrflite, and actinolite that are mined or milled. ((^`Asbestos moduct" means any mixture or article containing asbestos. <1 (d) "Consumer" means a natural public catusecte on the proposed ' person who uses a product for persona! reporting arui recordkeeping rather than business panoses. (TO) Mixed or repackaged asbestos fiber. (11) Thermopiugs. (12) Tape. {131 Roof coatings. (14) Clutch facinjji: r (15) Automotive gasket kit. ; (16) Drum brake ___ 3 (e) "Import" means to bring fata (17)Yinp^~^^\_~_____ -i List ofSubjects to 40 CFR Part 763 Environmental protection, Hazardous customs territory of the United Stats* for any purpose except (1) for shipment Qve(hIifcl)leAsu..t.o..m...o...b.il.e..s...a..n..d..o...t.h..e..r..m.. o...t.o..r..... \ through the customs territory of the svbstenees. Recoirikeeptag and United States for export without any 783.147 Pvrmtts to mine orimport reportingragusreaseitiss Asbestos. domestic use orprocesstag; or (2) entering the customs territory of fal Persons mar mine ia the United the United States as part et a product States or tamort Into the customs ! t i 1tt i i HWBUI0001315 3758_______ Federal Register / Vol. 51. No. 19 / Wednesday. January 29, 1988 / Proposed Rules territory of the United States only the or her application. If the appeal is quantity or' aspestos for which they hold mailed, the letter must be postmarked Permits issued under this SubpaftT within 20 days after receipt of EPA's " (b) The amount of asbestos contained announcement of disposition. in imported product listed in 783.145 (c) A person must indicate in an will count toward the total amount of appeal why he or she should receive a asbestos a person may mine or impart permit or be allowed to mine or import during a year. (c) Persons must estimate typical asbestos-content of imported aiFestoa products covered by this rule. Persons may uSeTSPA's estimate of typical asbestos content if they are not certain of the typical asbestos content of a additional asbestos under the permit. (d) The Director of the EPA Office of Toxic Substances will either grant or deny the appeal within 80 days after its receipt The disposition of the appeal will be announced by letter to the person making the appeal, product. (Ji 763.150 Transfer ot permltsT*) 763.148 Issuance of permits. {at A person issued a permit by EPA (a)(l) EPA will issue permits for the to mine or impart a quantity of asbestos mining or import of asbestos, including may transfer that permit in whole or in asbestos contained in the asbestos part to another person. products listed in 763.145. (b) A person who transfers a permit to (2) Applications for permits must be mine or import a quantity of asbestos sent to the Office of Toxic Substances and a person who receives such a (TS-79Z), EPA. 401 M St., SW.. transferred permit must report that Washington, D.C. 20460. transfer to the Office of Toxic fblfl) Persons must apply to EPA for Substances (TS-792), EPA, 401 M St., permits bv 30 days after the effective SW., Washington, DC 20460. within 10 date of this rule. days of the transfer. (2) Persons must list in their (c) The parties involved in a transfer application for permits the amount of may report either jointly or separately. asbestos, including asbestos contained in the asbestos products listed in 703.145. that they imported or mined (d) If a report is mailed to EPA, the report must be postmarked within 10 days of the transfer. during 1981,1982, and 1983. ^767S!13.151 Banktngof permits?^ (c) If an application is mailed to EPA. thp application must be postmarked bv :if) days .after the effective date of this rule. fdj EPA will allocate to persons who apply for permits auniform percentage liTthe amount of asbestos those nersons reported mining or importing during igffjrr98z7and 1983. "~Se) Each permit will allow a person to mine dr import the following percentages of the average amount of asbestos he or she mined or imported yearly during 1981,1982. and 1983. (a) Persons issued perrmtsby EPA to mine or import a quantity of asbestos dining one particular year may reserve or "bank" all or part of the permitted amount and use it to mine or import asbestos during a later year during the 10-year phase-down period. (b) The amount of asbestos that a person is permitted to none or import will decline from year to year ivhen it is reserved or "banked" at a rate of 10 percent per year.I * 111 (c) A person who "banks'" a permit in whole or in part must report that Year 1--30 percent. "banking" to the Office of Toxic Year 2--27 percent. Substances (TS-792), EPA. 401 M St. Year :J--24 percent. SW., Washington, DC 20400. within 00 Year 4--21 percent. days of the end of the year for which the Year 5--18 percent. permit was issued. Year 6--15 percent. (d| if a report is mailed to EPA. the Year 7--12 percent. report must be postmarked within 60 Year 8--9 percent. days of die end of the year for which the Year 9--6 percent. "hanked" permit was issued. Year 10--3 percent. d 763.153 Recordkeeping. i 763.149 Appeals concerning permits. I Any person who mines or imports (a) A person may appeal EPA'sinitial asbestos or any asbestos product listed disposition of his or her application for a in 5 763.145 must retain in one location permit. documentation of information showing: (b) The person must appeal in writing 111 The name of any person to whom to the Director of the Office of Toxic he or she transferred permission to mine Substances (TS-792). EPA. 401 M St.. or import asbestos. SW.. Washington. DC 20460. within 20 12) The name of any person from days after receipt of EPA's horn he or she received permission to announcement of the disposition of his mine or import asbestos. (3) The amount of asbestos mined or imported each year, including asbestos imported in any asbestos product listed in 703.145. (4) The typical asbestos content of any asbestos product listed in 703.145. (5) The number of individual asbestos products listed in 5 783.145 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. (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: "111 The person's name. (Z) The amount of asbestos imported. (3) The number of individual asbestos products listed in 8 763.145 imported: (4) A certification that the person was either is8ugg~a permit hv f-iPA tn import at least that amount of asbestos that year or obtained that permission from year covered by this Subpart, each person who mines or imports asbestos including agbestos tn an asbestos product listed 1tr(S763.145 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 hT763.145 that year.' (3) The number of individual asbestos products listed in S '63.145 that person itnpcrted that year. (4) The amount of asbestos that that ygaF ---- (c) If a report is mailed to EPA. the report rtiusrKe~pnstmarked within 60 days of the entfoFeach year covered by this SuEpirt. 763.156 Enforcement (a) Failure to comply with any provision of this Subpart is a violation of section 15 of the Act 115 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 ur 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). HWBUI0001316