Document 7OYZ8g0wQ0zJ6LM4kQEYyd8ag
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
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Federal Register / Vol. 51. No. 19 / Wednesday, January 29, 1986 / Proposed Rules
ENVIRONMENTAL PROTECTION AGENCY
OCFR Part 763
lOrr*-S203S; FRL 2*47-3]
*sNettoe; Proposed Mining and Import R**trtctlons and Proposed Manufacturing, Importation, and Frocoesing ProMbitiona
OCMCr. Environmental Protection Agency (EPA).
ertort Proposed rule.
wrssuutr 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 EPA 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
Ihose persons with permits issued by
EPA to mine or import asbestos for use
in products that are not banned.
Eventually, all mining or importation of -
asbestos would be prohibited, except for
ibat mining or importation allowed
under an exemption process. EPA is
proposing this rule to reduce the serious
unreasonable risk to human health
presented by exposure to asbestos. As
n alternative. EPA is considering
Prohibiting the manufacture, importation
and processing of categories of asbestos
Products at staged intervals. EPA is
considering
the manufacture.
Importation, and processing of asbestos
construction products and asbestos
clothing soon after the rule's
Promulgation with the category of
asbestos friction products banned about
years later, and other asbestos
Products banned at a later time. EPA
believes that this alternative approach
'Quid also be an effective way of
reducing the serious unreaaonble risk
presented by exposure to asbestos and
pacifically requests comment on a
*(aged ban of asbestos product
categories. Finally, under both this
alternative and the proposed approach,
EPA is considering requiring labeling for
all asbestos products that are not
banned, including products
manufactured pursuant to permit*
Issued by EPA during the phase-down
Period, or pursuant to an exemption
process. The Agency requests comments
" the feasibility and effectiveness of
uch a requirement
DATCS: Public hearings will be held beginning approximately May 14.1966. . The exact times and locations of the hearings will be available by calling EPA's TSCA Assistance Office. Comments on this proposed rule and requests to participate in the informal hearings must be submitted by April 29. 1966. Reply comments made in response to issues raised at each hearing must be submitted no later than 1 week after the close of that hearing.
anowisS' Since some comments are expected to contain confidential business information, all comments should be sent in triplicate to: Document Control Officer (TS-793), Office of Toxic Substances. Environmental Protection Agency. Rm. E-206.401M SL SW,, Washington. DC 20460.
Comments should include the docket control number OPTS-62036. Nonconfidential comments and nonconfldential versions of confidential comments received on this proposal will be available for reviewing and copying from 8 ssl to 4 p.m., Monday through Friday, excluding legal holidays, in Rm. E-107. at the address given above,
eon wnTHCR meomuTiON contact: Edward A. Klein, Director, Office of TSCA Assistance (TS-799). Office of Toxic Substances, Environmental Protection Agency. Rm E-543,401M SL SW,, Washington. DC 20460, Toll free: (600-424-9065). In Washington, DC: (554-1404). Outside the USA: (Operator--202-654-1404).
aum*NBfTAirr mfomuation:
Asbestos, since the advent of its lame acale use, has resulted in thousands of painful, premature deaths from lung cancer end other diseases. Because of the widespread use of asbestos and its particular nature, piecemeal control of the risks it presents is not satisfactory; only elimination of asbestos to the extent feasible will produce acceptable reduction of risks. Prevention of further deaths, therefore, requires forceful integrated action against asbestos risks. To achieve this end EPA has established a coordinated asbestos program aimed at controlling exposure to asbestos from products already in use and eliminating risks from future uses. The rale EPA is proposing today, which would ban certain uses of asbestos and phase out all other uses, forms a central element of this program Regulatory alternatives, which are discussed in this notice and which Involve staged bans of various asbestos product categories, could also form a central element of the 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 cases a year occur in the United States as a result of past exposure to asbestos: almost all of these cancer cases are fatal In addition, asbestos causes asbestosis (a serious lung disorder). About 65400 persons in the United States are estimated to be suffering from asbestosis today. Assuming current exposure levels, EPA estimates that about 2.560 persons will develop lung cancer or mesothelioma as a result of
exposure to asbestos from products made over the next 15 years, unless asbestos exposures are reduced through regulatory action. As discussed later, even with a relatively low workplace reL of 0.2 f/cc. EPA estimates that almost 1.325 cancers will result from asbestos products made over the next 15 years. The underlying data upon which
the risk assessments for asbestos are based come from a number of high quality epidemiologic studies. Unlike most potential carcinogens, asbestos has been studied often and thoroughly for its effects on humans.
Asbestos presents a particularly insidious threat because of the unique quality of its fibers. These fibers are small colorless, odorless, often invisible except through a microscope, and indestructible inmost uses. They can be transported on clothe* and other
materials, and they have aerodynamic features that allow them to be easily
suspended and resuspended in the air and to travel long distances. Once released, asbestos fibers are difficult to detect and contain, and they readily enter the ambient air. Thus persons are exposed not only at the time and place of release, but long after the release has occurred and far from its source. There is constant renewal of risk as asbestos fibers reenter the atmosphere repeatedly over time.
Despite the known risks of asbestos, substantial amounts of the material are till mined, imported, and used in
commercial products. About 240.000 metric tons, for example, were used domestically in 1964. Hundreds of products are still made with asbestos, including paper and textiles, cement pipe and sheets, tiles and felts, and automobile brakes. Asbestos fibers are released to the air at many stages of the commercial life of these products
Typical activities that lead to the
Federal Register / Voi. 51. No. 19 / Wednesday. January 29. 1986 / Proposed Rules
3739
release of asbestos include the mining of asbestos, Tiber processing into products, installation of products (e.g.. the sawing,
drilling, and sanding associated with
asbestos-cement products), product use (e.g., release of fibers during use of asbestos doth), product maintenance (e.g_ buffing and scraping of vinylaabestoe floor tiie or repair of asbestos-
containing brakes), dismantling and removal of*products (e.g.. removal of asbestos roofing felts), and disposal.
Release of fibers from these activities is substantial, resulting in exposure to
both workers and non-workers. EPA estimates that about 700 metric tons are released to the air during mining and milling each year, about 100 metric tons during product manufacture, and about 18 metric tons from landfills. These
estimates are probably low because they do not include releases from secondary fabrication of such products as millboard and asbestos-cement sheet much of which is done in small shops with inadequate emission controls. Observations that levels of asbestos in the air near manufacturing plants and in
cities are considerably greater than rural background levels seem to confirm that these releases occur and are significant
Release of asbestos fibers occurs not only in the manufacture and processing of asbestos products, but also in their use and maintenance. This release can
occur without the knowledge of the user or maintenance personnel. For example, construction workers tap into asbestoscement pipes already in place. The workers often do not know that the pipe contains asbestos and thus do not take steps to limit fiber release. Similarly, significant releases occur as a result of the use and repair of asbestos brakes and other friction products, which constituted about 22 percent of the total asbestos market in 1984. Ambient levels of asbestos are elevated near freeways, presumable due to release from asbestos brakes.
Thus, the manufacture, processing; and use of asbestos products leave a legacy of asbestos in the ambient air.
This ambient loading, while difficult to quantify, is a significant problem. The
National Academy of Sciences, after analyzing studies of outdoor air. estimated typical concentrations of
asbestos in outdoor ambient air in urban areas to be approximately 0.00007 f/cc (Ref. 0). Many millions of people are
daily exposed to these levels of asbestos in the air. The National Academy of Sciences has also estimated that persons in urban areas face a lifetime risk of between about 1 in 100.000 to
about 7 in 100.000 of developing cancer
as a result of asbestos in the ambient air
both indoors and outside of buildings (Ref. 6). Therefore, any comprehensive control strategy must take into account
the potential for exposure during the
entire lifecycle of asbestos products.
To date. EPA has focused its attention primarily on asbestos in buildings, a ma)or source of asbestos release into the
ambient environment In the 1970a. EPA banned the use of sprayed-on asbestos
and asbesto-containing pipe lagging under the Clean Air Act and since then has taken steps to reduce risks from
asbestos already in place in buildings. It
has issued an air standard to reduce emissions from asbestos removal and renovation projects in buildings; issued a rule requiring inspection of schools for friable asbestos; and established an extensive technical assistance program, which provides guidance to public and private building owners on the identification and safe removal of asbestos. EPA has also proposed an immediately effective regulation to protect State and local public employees who take pari in asbestos abatement activities.
These actions are primarily remedial, hddressing risks from asbestos already in place; they do no address the substantial risks that will result from the
continued manufacture and use of asbestos. Several other Federal agencies have already taken steps that partially reduce these risks. The Occupational
Safety and Health Administration (OSHA) has an occupational standard for asbestos with a permissible exposure limit (PEL) of 2.0 f/cc. OSHA has proposed to lower this standard to either 0.2 or &5 f/cc. In addition, the Consumer Product Safety Commission (CPSC) has banned use of respirable asbestos in consumer patching compounds and artifical emberizing
materials. However, substantial risk to workers and the general population remains. For this reason. EPA believes that only a major regulatory initiative under TSCA leading to the eventual elimination of most asbestos product manufacture and importation can
satisfactorily reduce the overall risk to all segments of the population.
The limitations of exposure-based regulations in preventing asbestos-fiber release, and the need for more
comprehensive action under TSCA. are illustrated by the use of PEL* to control workplace exposure. In the first place, it appears infeasible to set a PEL for asbestos low enough to reduce risk to a satisfactory level. Even at 0.2 f/cc. the lowest PEL proposed by OSHA. OSHA.
using the same lung cancer and mesothelioma models used by EPA.
estimates that about 7 in 1.000 asbestos
workers may die from an asbestosrelated disease. Furthermore, it is unreasonable to assume complete
compliance with a PEL of 0.2 f/cc.
especially given the nature of the asbestos industry. Many of the workers exposed are in the service and construction industries, where worksites change frequently and the worker
population is transient. Also, workers
often do not know they are exposed to asbestos and therefore will not take the necessary precautions. As a result. PELs
and other exposure controls are difficult
to apply and enforce. Beyond these considerations, a workplace-based approach does not address risks to the general population. EPA estimates that, even if OSHA reduces the PEL to 0.2 f/ cc, almost 1,325 cancers will still result from asbestos products made over the next 15 years.
Because of this residual risk. EPA is proposing under section 6 of TSCA a ban on the manufacture, importation, and processing of asbestos-cement pipe and fittings, roofing felts, flooring felts (and felt-backed sheet flooring), vinyl-
asbestos floor tile, and asbestos clothing. These uses would be banned because safer, economically competitive substitutes are available, and because these asbestos uses are likely to contribute large amounts of asbestos to the ambient environment or present
disproportionately high risk.
In addition, EPA is proposing to establish a permit system to phase out all other asbestos products. Under this system. EPA would allocate permission to mine or import a specific volume of asbestos to current miners and importers. The amount of asbestos a miner or importer would be allowed to mine or import would decline every year until after 10 years no mining or importation would be allowed, except under a specific exemption. This permit system would allow the market to allocate asbestos, based on the availability and cost of asbestos substitutes. After 10 years. EPA would put in place an exemption system for
those asbestos applications for which no substitutes had been developed. EPA anticipates that there will be few such applications, because the permit system
would create strong incentives for the development of substitutes. EPA is also considering a requirement that all asbestos products that are not banned be labeled aa containing asbestos. This would apply to products made pursuant to permits issued by EPA to mine or import asbestos, and to products made pursuant to an exemption process.
In encouraging the development of substitutes. EPA will be promoting a
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Federal Register / VoL 51. No. 19 / Wednesday. January 29. 1966 / Proposed Rules
significant reduction in risk. Currently,
sll products that are replacing asbestos in its many uses appear to present lower risk. However. O'A will monitor the development of substitutes during the
10-year phase-down period, and will use section 4 of TSCA to require testing of substitutes if necessary to ensure their safety.
As explained more fully later. EPA is
also actively considering other approaches to carry out a regulatory policy of phasing out the manufacture, importation, and processing of asbestos
products. Approaches under consideration include banning categories of asbestos products at staged intervals. Two categories under consideration are asbestos construction
products and asbestos friction products. Under this approach. EPA would ban the manufacture, importation, and
processing of all asbestos products within the category at the same tune.
EPA is considering this category
approach because products within each 'of the categories have similar exposure patterns, raise similar exposure control issues, and have similar substitutes. EPA believes that it may be good public policy to ban such categories of products at the same time. This approach would address similar exposure patterns in the same way and treat all parts of an industry sector similarly. In addition, both the construction products category and the friction products category contain products that could substitute for other
products in the category if all are not banned. Thus, a ban of tha entire category may be necessary to reduce risk most effectively.
EPA also considered referring
asbestos risks to OSHA and CPSC under section 9 of TSCA. EPA decided agBinst this approach because OSHA and CPSC in EPA's opinion, cannot adequately reduce the risk, given their authority and current control technologies. These agencies cannot comprehensively reduce the total volume of asbestos in commerce and cannot protect all of tha many
population groups at risk. Thus, action by these agencies under their separate authorities would still leave a large residual risk to workers and tha 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 it convinced that restrictions on the
manufacture, importation, and processing of ssbestos and asbestos products is the surest and moat effective
strategy for eliminating these risks.
. Background
in commerce if EPA finds that there is a
EPA announced that it was exploring possible use of TSCA to reduce the risk to human health from exposure to
asbestos in an Advance Notice of Proposed Rulemaking (ANPR) published in the Federal Register of October 17.
1979 (44 FR 00061). Following publication of the ANPR. EPA investigated industrial and commercial uses of asbestos. Under section 0(a) of TSCA. EPA promulgated an asbestos reporting rule under 40 CFR 763.00 published in the Federal Register of July
3a 1962 (47 FR 33207). This rule required
miners, millers, importers, and processors of asbestos to report information concerning (1) quantities of asbestos used in product manufacture.'
(2) employee expoanre to asbestos. (3) waste disposal practices, and (4) emission control practices. The information reported under that rule has been used with other data to evaluate the risks and benefits of asbestos use.
Under section 21 of TSCA. a person .
reasonable baaia 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 to health or tha environment.
Under section 6(c)(1) of TSCA. EPA must consider tha following factors when determining whether a chemical substance or mixture presents an unreasonable risk:
(1) The effects of such substance or mixture on health and the magnitude of the exposure of human beings to such substance or mixture.
(2) The effects of such substance or mixture on the environment and the magnitude of the exposure of the environment to such substance or mixture.
(3) The benefits of such substance or mixture for various uses and the availability of substitutes for such uses.
(4) The reasonably ascertainable
may petition EPA to Initiate a proceeding for tha issuance, amendment or repeal of a rule under
economic consequences of the rule, after consideration of die effeet on the national economy, small business,
various sections of TSCA. On June 21.
technological innovation, the
1979. EPA was petitioned to prohibit the environment and public health.
future use of asbestos-cement pipe in
After considering the above factors.
water systems. EPA granted that
EPA presents the following findings
petition by a notice published in the
concerning the unrestricted mining and
Federal Register of October16.1979 (44 importation of asbestos, including
FR 60155V On September 12.1964. the
asbestos imported in products.
Natural Resources Defense Council (NRDC) petitioned EPA to prohibit further use of asbestos In motor vehicle
A. Health Effects and Magnitude of Exposure to Asbestos
brakes. EPA granted that petition by a
1. Health effects. This unit
notice published in the Federal Register - summarizes the health effects of
of December 16.1964 (49 FR 49311). This asbestos. Detailed discussion and
proposal it in part a result of tha
assessment of the health effects of
proceedings conducted after granting
asbestos may be found in the "Report to
those two petitions. EPA his identified the United States Consumer Product
effective substitutes for asbestos-cement Safety Commission (CPSC) by the
pipe end is proposing to ben that
Chronic Hazard Advisory Panel on
product EPA analysed the availability Asbestos*' (CHAP) (Ref. 1). "Health
of substitutes for asbestos in brakes but Effects and Magnitude of Exposure" in
is not prepared to propose an immediate EPA's "Support Document for Final Rule
ban. Effective substitutes are still not
on Friable Asbestos-Containing
available for many applications of asbestos in brakes. Instead. EPA is
Materials in School Buildings." (Ref. 4) and the "Report of the (National
proposing to phase out use of asbestos Research Council) Committee on
in brakes and use market forces to
Nonoccupational Health Risks of
encourage the more rapid development Asbestiform Fibers" (Ref. 6V
of substitutes. As an alternative. EPA la
EPA finds that the adverse human
considering s ban of asbestos friction
health effects from exposure to asbestos
products about 5 yean after this rule is are extremely serious. Asbestos is a
promulgated. This alternative would
known human carcinogen that also
also encourage tha rapid development of causes other lung diseases. Asbestos
substitutes.
has been thoroughly examined in
L Regulatory Assessment
numerous epidemiology studies. The life-threatening diseases that have been
Section 6 of the TSCA authorizes EPA repeatedly identified are asbestosis,
to prohibit or limit by rale the amount of lung cancer, and mesothelioma. Also
a chemical substance which may be
associated with asbestos exposure in
manufactured processed or distributed soms studies are cancers of the larynx.
Federal Register / VoL 51, No. 19 / Wednesday, January 29. 1966 / Proposed Rules
3741
pharynx gastrointestinal tract kidney, and ovary and respiratory dieseaaes such as pneumonia. Major health effects are discussed below.
Lung cancer is currently responsible for the largest number of deaths from exposure to asbestos. It has been associated with exposure to all the principal commercial asbestos fiber types. Excess lung cancer has been documented in groups involved with the mining and milling of asbestos and the manufacture and use of asbestos products. Studies in which the extent of exposure can be approximated provide evidence that lung cancer increase linearty with both level and duration of exposure. Cigarette smoking and
asbestos have a strong synergistic interaction in development of lung cancer. Asbestos exposure appears to multiply the underlying risk of lung cancer. Consequently, when exposed to asbestos, the risk of lung cancer for smokers (for whom the risk of lung cancer is already high) is much higher than that for nonsmokers exposed to asbestos. Most persons who develop lung cancer die within 2 year.
Many baman studies have also shown that exposures to asbestos produce mesotheliomas, which are cancers that occur as thick diffuse masses in the serous membranes (mesothelia) that line body cavities. Mesotheliomas occur in the pleura (the membrane that surrounds the lungs and lines the lung cavity) and the peritoneum (which surrounds the abdominal organs and lines the abdominal cavity). Most persons who develop mesothelioma die within the first 2 years after diagnosis, often after having been in constant pain. Epidemiology studies suggest that the incidence of mesothelioma is related to dose and time from first exposure. Association of mesothelioma with smoking is weak or nonexistent. Asbestos fibers appear, by far, to be the moat common cause of mesotheliomas.
Asbestosis. which involves fibrosis of lung and pieurmi tissues, is another serious chronic disease associated with exposure to asbestos. There is no affective treatment far asbestosis end it is often disabling or fatal. Asbestosis is
diagnosed from findings which may include radiographic changes,
breathlessness, and abnormal lung function. Since some clinical symptoms of asbestosis are similar to those of ether fibrosing lung diseases, a history of occupational exposure to asbestos is often a key feature of its diagnosis. Asbestosis can appear and progress decades after exposure to asbestos fibers. Under working conditions where average fiber concentrations in the air
were high (more than 10 fibers per cubic centimeter (f/cc)) asbestosis has accounted for more than 7 percent of observed deaths (Ref. 11). It is apparently leas common than lung cancer or mesothelioma at exposures lower than the ament Occupational Safety and Health Administration (OSHA) workplace standard of ZJO f/cc. Some recent data on the incidence of .esbestoaie 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 nonoccupational 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 amoing 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 aR other sites combined is statistically significant in some studies.
Ths 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 ou 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 mesotheliome 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 end asbestos-related radiographic changes. In an ongoing study. 4 cases of
mesothelioma have been diagnosed among 626 family contacts of amosite workers (Ret 10). These figures are much higher than that expected to be found among the general population. In addition. 350 percent of the contacts showed chest x-ray abnormalities as compared with 40 percent of control subjects drawn from the same cofnnmnity. A number of mesotheliomas have also been documented among populations whose only identified exposne was from living near asbestos mining areas, asbestos product factories, or shipyards whan asbestos use had been very heavy (Ref. 4) An estimated 1000 cases of mesothelioma occur yearly in die US among various populations exposed to asbestos (Ref. 6).
Ia 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 at the potential for oral exposure as well as the excess of gastrointestinal tract cancers that has frequently been found in occupational groups exposed to asbestos in the air. there has been much study of the poeeible health effects of ingestion of asbestos fibers. Despite those efforts, evidence showing health effects from ingestion is still ambiguous.
2. Cancer risk extrapolation. As discussed above, numerous human studies have demonstrated that exposure to asbestos has increased the risk of cancer and asbestosis. Since a number of epidemiology studies indicate a positive relationship between asbestos exposure and the risk of hmg cancer, several models may be used to extrapolate from risk at higher exposure to risk at lower exposure. The model .that EPA believes is most consistent with the available human and animal data is the linear non-threshold dose/ response model. This model assumes that (1) any exposure increases risk, and (2) the increase in risk is proportional to the background risk in the nonexposed population and to the level of exposure, defined as duration of exposure times concentration of asbestos fibers to which populations may be exposed.
The choice of the linear model is reasonable since there is no evidence for a threshold level of asbestos
exposure below which there is no increased risk. It is further supported by evidence of cancers among populations whose asbestos exposure is believed to have been lower than levels reported in the epidemiology studies of asbestos workers mentioned above.
The model adopted by EPA to estimate excess mesothelioma incidence due to asbestos exposure relates disease
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incidence to dose and the time from first exposure (minus 10 years) raised to the third power. This model reflects a delay (or minimum latency period) of 10 years between first exposure and the likely
earliest possible appearance of the disease. Both the lung cancer and mesothelioma models have also been adopted by OSHA (Ref. 12). The National Research Council Committee on Nonoccupational Health Risks of
Asbestiform Fibers also adopted a similar linear no-threshold model to
estimate risk to nonoccupational populations from exposure to asbestos . (Ref. ft). The derivation and validation of the models is discussed in detail in the CHAP report (Ref. 1) and in EPA'i
"Regulatory Impact Analysis of Controls on Asbestos and Asbestos Products" (RJA) (Ref. 3).
Although EPA believes that excess mortality from asbestosis and cancers other than lung cancer and mesothelioma will occur from exposure to asbestos released during the lifecycle 'of the products under study. EPA has not attempted to quantify that excess mortality. Thus, the model could understate the risk to humans from exposure to asbestos.
The risk of asbestos-induced disease
may be modified by several factors. As mentioned in the earlier discussion on
lung cancer, smoking drastically increases the risk of developing lung cancer from exposure to asbestos. Because of their lower underlying risk, the absolute increase of incidence of lung cancer in nonsmokers is about onetenth of that in smokers. However, even complete control of the smoking factor (if possible) would leave a substantial health risk since the risk of mesothelioma (which is apparently unaffected by smoking) and the risk of lung cancer to nonsmokers would still remain.
Another factor that may affect the risk of asbestos-induced disease is the possible differences in biological potency among the different fiber types. The National Research Council (ReL ft) studied this issue and concluded:
Result* of studies of various groups of workers indicate that it it extremely difficult to attest the role of fiber type (e g., chrysolite or crocidolite) in determining the risk for developing either lung cancer or
mesothelioma. Analysis of the epidemiological studies is complicated because of venation* in type of industry, the diverse fiber characteristics within an industry, and the usual inadequacy of exposure dsta. Some scientists have interpreted the available epidemiological data to indicate that chrysolite asbestos, the asbestos type most commonly used in the United States, is less hazardous than the other types of asbeflot. especially rroc.dolite Such arguments have been used
in the United Kingdom and other countries to rationalize different regulatory controls for crocidolite end chrysotiie. However, in view of the laboratory evidence and greet 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 of asbestos. EPA hat concluded that it is prudent to treat all asbestos fiber types as having equivalent biological activity.
Fiber morphology has also been suggested as a factor that may affect incidence of asbestos-induced disease. Animal studies in which asbestos fibers 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 bee been established.
3. Magnitude ofhuman 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 characteriatica 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. Asbestos fiber concentrations have been
measured in areas far from obvious asbestos sources. Atmospheric sampling programs conducted in remote rural areas in the United States and Germany have found asbestos fiber levels between 0.01 and 0.12 nanogram/meter'
(ng/m*) (1 ng is one billionth of a gram). Conversion factors between asbestos fiber counts and mats counts are variable. However. EPA estimates that 1 ng of asbestos in sir equals about 30 fibers visible by light microscopy. Using this conversion factor for asbestos in outdoor air. then the above measurements are the equivalent of about 3X10~T to 3.0X1O~* f/cc. In areas of higher human population density, measured asbestos concentrations in the air are typically much greater. A survey of large cities showed mean readings of 2.# to SO ng/m* (70X10"* to 1.5X10*4 f/ , cc). Measurements taken in New York City ranged from means of 8 to 30 ng/m*
(2.4x 10"4 to 9xl0"4 f/cc). Typical fiber concentrations are much higher in densely populated areas because of fiber release from construction work (including renovation or demolition), from asbestos-containing brakes of motor vehicles, and from other activities during the lifecycle of asbestos products. In general, levels of aabeatos in the air in cities and near manufacturing plants are considerably greater than rural background levels.
Thus, throughout their entire lifecycle, that is throughout thei* 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 000007 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 of asbestos products.
Some products do not present as much potential for releases to the ambient air during certain stages of their lifecycle. For example, there are likely to be releases to the ambient air during the manufacture, processing, installation, and repair of asbestos-cement pipe. However, there generally will be no release of asbestos to the ambient atr during actual use of asbestos-cement
Federal Register / Vol. $1. No. 19 / Wednesday. January 29. 1966 / Proposed Rules
3743
pipe since it is commonly buried in the ground.
A large proportion of the U.S. population is at risk from this asbestos in the air. Tables I through QI show the numbers of persons exposed to asbestos during the more readily quantifiable stages of the lifecycle of asbestos products and the levels to which they are exposed. Exposure levels are "best estimates" based on monitoring studies. Additional information can be found in Refs. 2 and 3 which are included in the rulemaking record. To avoid disclosing confidential business information, the tables sometimes use a range rather than a single number. The notation NA means that data are not available.
Table I.--Exposure data ran manufactumng--Occupational
TABLE II --Exposure Data tor Manufacturing--Ambcnt--Cononued
Table M.--Exposure Data For tastaHaton. Use. Repair, and Disposal
0-190
>190
X7 o-ao mm
47
$40 6-190
MOO
Cto*.
PKtung______ coMngt _
SOI 07 1.016 o-tao zjn 40
m (VI90 1.447 im um tM 0-190 i.m 460 UM m
1X1 UH ajot
TOO
1X4
m
470
0-10
190-00 106 747
900
-10
41
TABLE I.--Exposure Oats for Mamufactumnq--Amment
--
tmmry raanutecMWt 52*
faamsmsl jmfms
--tot pM Mpr-------------Enks mem_________________
001M
AIM Q01 .00106 .QD1M
Floors tm _______________
V/A door m .....
_
FMCiLa arsf ftoonng ________
A'C PC* .. ... .......... ..........
F A/C UM . ................ .
0l6 HA
X166 469
HA 307 3.07
IB Ortft
30.000 160X0 360.000 70.000 mom 60000
NA
roooo 60.000
NA
1.700.000 790000
4. Exposure from imported and exported asbestos and asbestos products. EPA has determined that significant exposure is likely from imported asbestos products. Although some exposure to United States populations is avoided when asbestos products are manufactured abroad and imported rather than manufactured domestically, significant exposures will
still occur after their import into this country. Exposures will occur during installation and use of the product; maintenance of the product; and during dismantling, removal, and disposal of
the product. Much asbestos can be released to the ambient air as a result of these activities. Large numbers of people are exposed to asbestos during these activities and the level of exposure can
be quite high.
Significant exposures will also occur during the domestic life cycle of bulk asbestos and asbestos products manufactured in this country for export abroad. These exposures will occur during the ""i"g and milling of asbestos fiber and during the processing of fiber into products. There is much exposure to workers during the mining and milling of asbestos and manufacture of asbestos products. In addition, families of workers, and populations living near mining and manufacturing sites are also exposed to asbestos as a result of these activities.
S. Exposure from various categories of asbestos products. EPA has noted that various categories of asbestos products present very similar exposure patterns. For example, the products within the construction products category all present significant potential for fiber release to the air and subsequent human exposure during their installation, repair, removal, and disposal. These
products are often cut tom. sawed, and drilled during installation repair, and removaL All of these activities can release fibers to the air. In addition, sanding of these products during use often releases fibers to the air.
Similarly, products within the friction products category all present significant potential for fiber release and subsequent exposure during use and repair. Friction products wear down during use, often releasing fibers to the
air either during actual use of the product or during maintenance or repair operations in which previously confined asbestos-oontaining dust is disturbed and becomes airborne.
Often, fiber releases from asbestos products in these categories occur in close proximity to other products within the same category, making it difficult to attribute observed fiber levels to a particular product For example. EPA used monitoring data from automobile repair shops to estimate asbestos exposures resulting from repair of asbestos disc brakes, drum brakes, clutch facings, and automatic transmission friction components. Because there are no data available to estimate differences in fiber releases in the various repair activities, EPA
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Federal Register / Vol. 51. No. 19 / Wednesday. January 29. 1986 / Proposed Rules
developed exposure estimates for each product using a weighting scheme based on the relative production volumes of each of the friction products which are the sources of the exposure. Similarly, it is common for many of the asbestos construction products to be used at one building site, making it difficult to attribute fiber release to one particular product The estimation of ambient exposures due to releases horn individual construction products, such as the various flooring products, was difficult since monitoring data were gathered in buildings where more than one type of asbestos flooring product was in place.
For these reasons. EPA believes that it may be appropriate to consider a categorial approach to analyze the risk presented by asbestos products and to control that risk. Table IV lists the products that are included in the construction products and friction products categories.
Table iv--Examples of Asbestos Procxjct Cateqowes
6. Quantitative cancer risk estimates. As discussed above, there exist many asbestos exposure-producing activities to which many kinds of populations are exposed. Applying the cancer models described above to the available data on exposure and populations. EPA has estimated the number of cancers that may be avoided by implementing the EPA's proposed regulatory program. (A full discussion of the risk estimates is contained in the "Regulatory Impact Analysis of Controls on Asbestos and Asbestos Products (Ref. 3)". Using available data and assuming current exposure levels. EPA calculates that about 2.580 lung cancers and mesotheliomas in the United States would result from production of asbestos products over 15 years without EPA action under TSCA. EPA calculates that this rule would avoid about 1.930 of those potential cancers. Assuming that OSHA achieves strict compliance with a PEL of 0.2 f/cc, EPA calculates that about 1.325 lung cancers and mesotheliomas would result unless EPA takes action under TSCA. EPA
calculates that this rule would avoid about 1.000 of those potential cancers.
EPA also calculated the number of
potential cancers avoided by the regulatory alternatives discussed later. Assuming current exposure levels,
alternative 1. which would ban the asbestos construction products category and asbestos clothing soon after promulgation of the rule and ban the asbestos friction products category
about 5 years later, would avoid about
2.100 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 3. which would ban the asbestos construction products category and asbestos clothing soon after promulgation of the rule and cover all other asbestos products under the phase-down, would avoid about 2.020
cancers.
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. Without regulatory action, manufacture
of 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 cancer of about 1 In 100.000 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. 6). 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 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 of the dose-response relationship for mesothelioma and lung cancer. Risk estimates more than four times as high could be justified(Ref. 3).
e. EPA did not attempt to quantify . reductions of cases of asbestosis and cancers other than mesothelioma and lung cancer. These diseases may add 10 to 20 percent more deaths to the total. OSHA estimates that at an exposure of 03 f/cc over a workingcareer. 12 workers per 1300 will develop asbestosis (Ret 12). Thus, incidence of asbestosis could be significant among worker populations and possibly among other populations as well. In addition, in a major study of insulation workers ; exposed to asbestos, about 10 percent of all excess deaths were attributed to cancers other than lung cancer and mesothelioma (Ref. 11).
B. Environmental Effects
Section 6(c) of TSCA requires that EPA state the relevant environmental factors and key considerations which form the basis for regulatory action under section 0(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 Availability of Substitutes
The benefits of the asbestoscontaining products affected by the proposed rule are discussed below. Overall. EPA finds that the benefits to society of these asbestos-containing products are small since suitable substitutes are now available for most uses and applications of asbestos, and products are being developed that will replace almost all uses and applications of asbestos during the phase-down period of this proposal.
1. Substitutes. The detailed results of EPA's analysts 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.
Federal Register / Vol. 51. No. 19 / Wednesday. January 29. 1986 / Proposed Rules
3745
Table v--Summary Table of Asbestos Phooucts. Them Major Uses, ano the Extent to Whcm They Can be Sosstttut-
Table v--Summary Table of Asbestos Prooucts, Them Major uses, ano the Extent to Which They Can be Substitut ed--Continued
The following examples illustrate the types of substitutes available for those asbestos products EPA proposes to baa either in this proposal or in one of the 3 regulatory alternatives described in this proposed rule, including the category of asbestos construction products and the category of asbestos friction products. A more complete analysis can be found in the Regulatory impact Analysis (R1A) (Ref. 3).
a. Friction products. Substitutes exist or are being developed for almost all uses of asbestos in friction products. Replacement of asbestos in friction products has been more difficult than in the other asbestos product categories because of the unique combination of physical properties of asbestos which make it so well suited for friction products, e g- heat resistance, corrosion resistance, high tensile strength, thermal stability, and processability. However, substitutes which are nearly as costeffective as asbestos products have been developed for most uses of asbestos in friction products.
Asbestos automatic transmission friction components are currently being replaced with cellulose-based friction components. Only one of three domestic manufacturers of clutch facings makes them using asbestos. Clutch facings
made of fiberglass and textile fibers
have begun to replace asbestos facings to a significant extent However, these substitutes are inferior to the asbestos clutch facings in durability, quietness,
and tensile strength. Product development is continuing, however, to improve fiberglass facings to increase strength, wear, and ability to withstand heat through the use of special binders. Aramid-fiber-based clutch facings are
also being developed. However, these have been relatively expensive compared to the asbestos and fiberglass
clutch facings.
Semi-metallic disc brake pads have largely replaced esbestos disc brake pads in domestic cars with front wheel drive. Cumntly. about 85 percenlr'of new domestic cars have front wheel drive and are equipped with semimetallic front disc pads. Also, a number of brake manufacturers have begun to introduce an aramid fiber into
production of disc brake pads.
The development of substitutes for asbestos drum brake linings has not been nearly as successful as it has been for disc brakes. Manufacturers have reported problems in processing nonasbestos fibers and problems in meeting standards of durability and heat resistance. There has been limited progress to date. One automobile manufacturer has reported that its new
minivans are equipped with semimetallic drum brake linings and one brake manufacturer has begun marketing aramid fiber-based linings for the replacement brake market. In addition, one automobile manufacturer has reported progress in developing a nonasbestos drum brake lining using an aramid fiber. However, domestic car manufacturers have not begun installing aramid-based or semi-nietallic-based drum brakes linings on new vehicles except in very limited applications. A number of other substitute fibers are being tested by manufacturers and may
have potential as a substitute for asbestos in brakes.
b. Asbestos cloth products. Asbestos
cloth has been used as a final product in safety curtains, fire blankets, protective clothing, and high-temperature conveyor
belts. Asbestos cloth is used as an input product in gaskets, packing, friction materials, and thermal and electrical insulation.
There currently are a number of
substitute fibers for asbestos use in
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Federal Register / Vol. 51, No. 19 / Wednesday. January 29. 1986 / Proposed Rules
doth. These indude glass fibers,
ceramic fibers, carbon fibers, organic
fibers, quartz fibers end cotton fibers.
Replacement fibers for asbestos in doth
uses depend upon the specific
application.
Substitutes appear to be available for
almost all high-temperature applications
of asbestos doth. If asbestos doth were
not available. EPA expects that the
following substitutes would replace
asbestos doth as follows:
Fiberglass doth products: 50 to 00
percent
Armmid doth products: 20 to 25
percent
Carbon/graphita doth products: 5 to
10 percent
Ceramics and silicon-based doth
products: 10 to 15 percent
Because of their temperature and
flame resistance, asbestos clothing
products protect wearers from fire and
heat However, substitute products have
been developed for asbestos dothing
products. Aramid doth products can
substitute for asbestos in protective
'garments, but are more expensive. Soma
other
products made without
asbestos are less expensive than the
counterpart product made with asbestos
doth. Substitute products for ssbestos
dothing indude nomex. fiberglass, and
zetex. Asbestos dothing has been'
replaced by substitutes in most or aO
firefighting and industrial applications.
c. Asbestos-cement pipe andfittings.
Products in this category are
manufactured for various uses. Moat
pipe is used to carry water or sewage. A
mall amount is used to cany 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 pips types and sizes. Based on
information from manufacturers, EPA
niwlnrWl that operation and
maintenance costs and service lift of all
products are essentially similar.
Asbestos-cement (ripe does not
dominate any sepnant of the pips
market, but is popular for certain
applications such es carrying water at
low pressure. If this rule Is promulgated.
EPA expects that the following
substitutes will replace asbestos-cement
pipe as follows:
Putjvtiiyi chloride (PVC) pips , ...72 percent Ductile toon pipe______ 23 percent
Prettrssssd ooucrets pips---------- 42 percent Reinforced concrete pips---------- (US percent
These estimates are only approximate and do not taka into account other possible substitutes that EPA considered
somewhat less suitable than those noted above. These include various plastic and vitrified day pipes.
All of the substitutes considered are well established in the pipe market and
can be Joined to or replaced existing asbestos-cement pipe sections.
d. Roofing fell Asbestos roofing felt is used for built-up roofing, primarily on flat roofs. "Built-up" refers to the practice of layering felt lengths on top of each other with hot roofing tar or asphalt mopped between layers of adhesion and additional weather protection.
Currently, leu then 10 percent of
roofing felt sold contains asbestos. Organic felt, fibrous glau felt end single-piy membrane roofing ail have greater shares of ths flat roof market then asbestos felt.
Of these three well-established products, fibrous glau felt most closely approximates asbestos roofing felt in purchase and installation prices end service life. Organic felt has a lower purchase price, but has lower insulation value and moisture resistance end a somewhat shorter service life. Single-ply membrane roofing consists of a laminate
of e modified bitumen or polymeric system such as polyvinyl chloride or ethylene propylene diene monomer. A typical product consists of a five-layer laminate composed of a thick plastic core 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 fell is about es expensive to install, but is expected to have a longer service life. Single-ply membrane also has the advantage of not requiring the uss of hot asphalt during installation.
e. Flooringfelt andfelt-backed vinyl sheet flooring. Asbestos flooring felt was used es 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. Alarge number of non-asbestos vinyl
flooring products have entered the market in the last S years. These products include sheet becked with felt
containing fibrous glass, cellulose, polyethylene or polypropylene fibers, ceramic fibers, and plastic foam. Also available are unbacked sheet and numerous treditlonel flooring products such es ceramic tiles, capeting, and
wood flooring Among these many products, consumers will find adequate
substitutes for any particular see of aebestos containing feh or felt-backed flooring.
EPA has found that price differentials between asbestos and non-asbestos vinyl sheeting are negligible. Overall, the backing is a small part of the total
cost for vinyl sheet products.
Maintenance and service life are not materially affected by the backing. The wide range of prices found among various vinyl flooring products are mostly attributable to the colors and pattema of the vinyl as well as the
wear-layer thickness.
f. Vinyl-asbestos floor tile. Vinylasbestos 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, end resistance to
moisture, heat and oil. Currently, the most suitable available
substitutes for vinyl-asbestos floor tiles ere various asbestos-free vinyl composition floor tiles. In place of / asbestos fibers, manufacturers are using synthetic fibers including fibrous glass, polypropylene, polyethylene, and cellulose.
There are also several types of vinyl tiles that contain various fillers and resins in place of fiber. Many 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 last as long as the asbestos tiles,
while others believe service lives will be shorter. EPA currently assumes that service lives of the non-asbestos tiles will be about one-third shorter than for the asbestos tiles.
g. Asbestos-cement sheet There are a number of cost competitive substitutes for asbestos-cement sheet. These include both products using substitute fibers and other product substitutes. Glass-reinforced concrete is suitable for most corrosion and heat-resistant applications where asbeatos-cement sheet is now used. Glesa-reinforced concrete is widely available at a price
that has been declining relative to that of asbestos-cement sheet. Cement-wood board is suitabls 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 greater corrosion resistance than the other products. In cooling towers, polyvinyl chloride products or ceramic
Federal Register / Vol. 51, No. 19 / Wednesday. January 29, 1986 / Proposed Rules
3747
tile products are cost competitive and
a. Fibrous glass appears to be
are suitable for most applications. There considerably less hazardous than
are also a number of products that can asbestos based on (1) morbidity and
substitute for asbestos-cement sheet as mortality studies in workers. (2) in vivo
a laboratory desk top and fume hood
and in vitro experimental data. (3) the
bench. However, it appears that
order of magnitude lower exposure
comparably priced products may not
potential in the workplace. (4) the
fully match the qualities of asbestos-
generally less respirable nature of the
cement sheet in these applications.
airborne fibers, and (5) the less durable
h. Asbestos-cement shingles. There
nature of the fibers in the lungs.
are substitutes for asbestos-cement
b. Mineral wood does not appear to
shingles for both roofing and siding
present the significant risks that
applications. The primary substitutes for asbestos-cement roofing shingles are asphalt-fiberglass composition shingles,
cedar wood shingles, and various synthetic and natural tiles, such as Monray n'ofing tile and concrete tile. Asphalt-fiberglass composition shingles cost about half as much as asbestoscement shingles in terms of purchase and installation costs but have only about half the operating life. Cedar wood shingles have a slightly greater cost then asbestos-cement shingles but have a greater operating life.
Substitutes for asbestos-cement shingle siding include wood, wood shingles, aluminum siding. PVC siding,
stucco or concrete block, vinyl and brick. Aluminum and PVC siding are both virtually identical to asbestoscement shingles in terms of price and durability. Cedar shingle siding is also very competitive in terms of price, but it is somewhat less durable.
The total substitute market for both applications is approximately as follows:
asbestos does based on (lj limited animal data and morbidity and mortality studies for workers, and (2)
the lower exposure potential in the workplace.
c. Ceramic fibers do not appear to present a comparable risk to that of
asbestos based primarily on (1) the moderate workplace concentrations, and (2) the specialized applications which include its encapsulation or incorporation into products.
d. Carbon/graphite fibers are probably not a significant health risk
based on the (1) use of coatings on the fibers which may reduce their respirability, and (2) low intrinsic
respirability characteristics. e. Aramid fibers appear to present
relatively low risk because they are basically nonrespirable as currently produced and processed.
f. Polyethylene and polypropylene
pulps and fibers appear to present
relatively little risk since they appear to be relatively nontoxic and
nonrespirable. g. Attapulgite has large general
Asphalt/fibergiast.......... ..........-- SO percent exposure potential but available
Wood products.......... .....
30-35 percent evidence suggests that attapulgite from
APBVnlucCmk,tinidtuilienm-g-t-.i.-d.-.-.i-.n-..-g.-.-.._-.-._.--_-_--_-_-_________5_-1__05_pp_eerr5cc-ee1nn0ttpercUaseud.nSbdt.sitmtiiotiunnte,esaftomtarapayuslpbgreietsestoeissn.tnloitttlaemhaazjoarrd. In
2. Possible hazards of substitutes.
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 (Ret 14). Some of the
monomer used to produce
substitutes such as wood-based
polyvinylchloride, is a carcinogen. The
products (e g, cellulose fiber products) polyvinylchloride product itself presents
and construction products made of brick little risk and workplace exposures are
and concrete appear to present little
apparently adequately controlled.
risk. While other substitutes present
L 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 risk to human
substitutes may be new chemical
health as asbestos. EPA made extensive substances for which a premanufacture
use of the work of the National Research notice (PMN) must be submitted under
Council and agrees with their conclusion 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 fibrous glass,
substances that are less hazardous than
attapulgite. and carbon fibers, appears the chemical substances they replace.
to be much less than for nsk from
EPA encourages the development of less
asbestos, especially chrysotile" (Ref. 6). hazardous new chemical substances as
The conclusions of EPA s analysis of
asbestos replacements. Potential
specific substitutes follows.
developers of new chemical substances
intended as asbestos substitutes may wish to discuss their plans with EPA during a prenotice consultation. Such a consultation can be arranged by contacting the Prenotice Communications Coordinator by telephone at (202-382-3745) or by writing to the Prenotice Communications Coordinator, Chemical Control Division (TS-794). Environmental Protection Agency, 401M Su SW,, Washington. DC 20460. Through a prenotice consultation. EPA can inform potential PMN submitters of legal requirements, possible EPA health concerns about the aubstance. and possible test data that EPA may believe necessary to evaluate the risk potential of the aubstance. During a prenotice consultation and any PMN review of a new chemical substance that is intended as a substitute for asbestos, EPA will consider the relative risks presented by asbestos and potentially presented by the asbestos substitute. EPA will make every reasonable effort to provide prompt and clear information concerning the likely result of PMN review in view of EPA's policy of
encouraging less hazardous substitutes for asbestos.
D. Economic Effects of Proposed Rule
This portion of the preamble presents EPA's determination of the "reasonably ascertainable economic consequences of the rule" as required by section 6(c)(1)(D) of TSCA. .
EPA has prepared a "Regulatory Impact Analysis of Controls on Asbestos Products" (Ref. 3) which analyzes the potential economic impact of this proposed rule. The economic impact is summarized and explained below.
Estimated costs are mainly from 1981 data obtained under EPA'ssection 8(a) asbestos reporting rule (40 CFR 763.00). Some of the data were adjusted to reflect more current information on production of asbestos products. Specifically. EPA gathered more current information on the use of asbestos clothing and asbestos flooring felt and then adjusted the estimated costs and benefits of the rule to reflect declining use of these products. The sources of the information are noted in the record for this rule. The costs are presented as the net present value of costs incurred due to changes in asbestos product production between 1965 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
3748
Federal Register f VoL 51. No. 19 / Wednesday. January 29. 1986 / Proposed Rules
asbestos products will remain constant
over the time period used for measurement of coats. Actually, price differentials are likely to decrease over time.
Two types of costs are estimated in the RIA: (i) Coats to consumers and (2)
costs to producers. These are discussed below. The coots represent the present
value of losses incurred over the 15-year period from 1965 to 2000. using a discount rate of 10 percent.
1. Consumer losses due to the rule would result bum increases in costs incurred for asbestos product* or
substitutes for asbestos products and from inferior performance of substitute products. Total consumer losses due to the rule are estimated to be S1.77 billion. However, this loss would be spread across the entire consumer population and would average less than $10 per consumer over 15 yean. This rule would not cause dramatic cost inmeases in typical consumer products.
2. Losses, would accrue to producers as a result of the rale when producers are forced to forgo come portion of the return on their capital stock used to produce asbestos products. Owners of equipment which can be readily converted to make other products are not expected to lose nearly as much as owners of equipment which cannot be easily converted. Total producer costs are estimated to be about $206 million
for the rule. 3. In addition, the rule would result In
transition costs to workers who are displaced by phasing down production of asbestos products. These losses are incurred in the form of lost wages and Job search costa. EPA believes that transition costs of the phase-down will be relatively modest since the rule would allow industry to scale back production gradually and shift production to other products and that the transition costs from the proposed product bans will be small in comparison to the consumer and
producer costs. The sum of these coots, about $1.66
billion, represents the estimated total real resource oasts of the rale. This cost would be spread over 15 year*. The coet will also be spread over a large population and the imped on most
persons would be negligible. la addition. EPA estimated the real
resource coats of the product bans proposed ia this rale. These estimates sre shown below:
frown
a/c ra*_____________ Boor <* _____________ Boom* <M
*iS< UHon
*it* uaoit
il Moor
142 tutor
The above costs of the rale will be offset to some extent by the following avoided costa.
By reducing the amount of asbestosrelated deaths and illnesses this rule would reduce the cost to society of the health resource* uaed to treat asbestos-related illnesses (e-g.. hospital and medical treatment) and the productivity (wages and loat work capacity of sick workers, etc.) lost as a result of illness caused by asbestos exposure. EPA estimates that the avoided morbidity cost it about $1,275 per case. This is measured in 1965 dollars using a 10percent discount rata.
This figure is relatively low because people generally contract mesothelioma or lung cancer after a long latency period. Thus moat medical coats occur far in the future and are therefore discounted heavily.
EPA did not attempt to value the loss of life itself. In addition, no value was assigned to "pain and suffering." "loss of `leisure time.*" and other similar losses.
Substantial asbestos removal and disposal costs would be avoided as a result of this proposed rule. These include avoided expense* aa well as avoided health risks for people exposed during removal and disposal activities. Use of nonasbestos products in construction reduces demolition and disposal costa in the future. Removal and disposal cost* 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. Hies* costs can ha substantial. EPA has estimated that removing aabestoa from school buildings costs between $2 and $13 per square foot of asbestos removed.
OSHA and EPA both have regulations to limit aabestoa exposure at work sites. Certain costa related to compliance with these regulations would be avoided aa a result of this rule. To comply with OSHA# 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 saws,
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 tpecial laundering.
f. Labeling asbestos material and posting caution signs.
g. Providing special procedures f6r 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 asbestos-
related activities release "no visible emissions." To comply with this requirement, persons must obtain and maintain air-cleaning device* such as filters and may be required to modify work and waste disposal practice! to reduce emissions.
In addition, both OSHA and EPA may require stricter workplace controls for asbestos in the near future. The coats 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 6(c)(1)(D) of TSCA EPA has analyzed the economic impact of this proposed nils on small businesses. The effect of this rule on such businesses is expected to be small because (1) there are few small businesses producing asbestos products and (2) producer losses are expected to be small since capital equipment for production of moat asbestos products
can be converted fairly easily to other forms of production. A maximum of 27 out of the 212 primary processors of asbestos products are small businesses. EPA scknowledges 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.
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3749
However. EPA acknowledges that a higher percentage of secondary processors are likely to be small businesses than the percentage of primary processors that are small businesses. In addition, 5 of the 11 companies that manufacture the products that this rule proposes to ban are small businesses. This proposed rule could have significant impact on these few companies.
The estimated costs of the rule could be seen as significant. However, the overall benefits to society of asbestoscontaining products are diminishing with the current availability and the continued development of various nonasbestos substitutes. The costs of the rule are speculative and probably are overestimated. In addition, many economic impacts of this rule are likely to be short-term and spread across large populations with only negligible impact on the typical consumer. This rule is not
expected to cause dramatic price increases in typical consumer products. Consumer losses caused by this rule would be spread across the entire consumer population, fobs displaced by this rale are likely to be offset by increased employment in companies producing substitutes for asbestos products. Potential consumer and producer costs are likely to be offset by the economic costs avoided by this rule, i-e- avoidance of the morbidity costs of asbestos-related diseases; the cost of removal and disposal of asbestos products; the costs of special control to reduce exposure to asbestos and costs associated with legal actions seeking compensation for asbestos-related illnesses and deaths. Finally, the
estimated costs of this rule appear reasonable in view of the unreasonably large number of asbestos-related deaths and serious illnesses that would occur without a phase-out of asbestos.
EPA expects that this proposed rule would have a positive impact an technological innovation and encourage the continued rapid development of nonasbestos substitute products. Tide development of new products is likely to involve significant technological innovation.
TV. Other Options Considered
Section 8 of TSCA requires that EPA apply the least burdensome requirements to reduce an unreasonable
risk. EPA is considering a number of options for implementing the regulatory policy of phasing out the manufacture and importation of asbestos products. These options involve staged bant of categories of asbestos products. This approach would bsn the manufacture, importation, end processing of all
asbestos products within a certain category at the same time. EPA is considering a category approach for groups of asbestos products with similar exposure patterns, similar exposure control issues, and similar substitutes.
Examples of categories under consideration era construction products
end friction products. EPA believes rt may be good public policy to ben categories of products at the seme time.
This approach would address similar exposure patterns in the same way and treat all parts of an industry sector similarly. In addition, both tbs
construction products category and the friction products category contain products that could substitute for other products in the category if all are not banned. Thus, a ben of the entire' category may be necessary to reducs risk moat effectively.
One option under active consideration in addition to the ones embodied in the proposal it banning the manufacture, importation, and processing of the asbestos construction products category and asbestos clothing with the ban affective soon after promulgation of the rule: banning the manufacture, importation, and processing of the asbestos friction products category about 5 years after promulgation of the
rule; and gathering up-to-date production, exposure, end use data on the remaining asbestos products under section 8(a) of TSCA to support possible bens of other asbestos products et that time. Another option is banning the 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.. 10 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 ell other asbestos products under the phase-down. Under each of the options, EPA is also considering a requirement that products not banned soon after promulgation be labeled as containing asbestos.
EPA is actively considering these options as alternatives to this proposed rule end specifically requests comment on these alternatives. EPA may sdopt a final ruls based closely on one or t combination of these alternatives. These alternatives are discussed more fully below.
1. Ban the asbestos construction
products category and asbestos clothing soon afterpromulgation of the rule, ban the asbestos friction products category
about 5 yean later, andgather additionalinformation on other
asbestos products. Under this alternative. EPA would ban the
manufacture, importation, end processing of tha asbestos construction products category (i.e.. asbestos-cement pipe and fittings, roofing felts, flooring
felts and felt-becked sheet flooring, vinyl-asbestos floor tile, corrugated asbestos-cement sheet flat asbestoscement sheet end asbestos-cement
shingles) and asbestos clothing soon
after promulgation of the rule. Effective substitutes exist for these product*. The rule would also ban the manufacture, importation, end processing of tha asbestos friction products category (i.e_ drum brake linings, disc brake pads for light medium, and heavy vehicles, brake blocks, clutch facings, automatic transmission friction component* and industrial and commercial friction materials) 5 yean after promulgation of the rule. This alternative would reduce exposure to asbestos without the administrative burden of EPA
establishing and operating a permit system as in the proposed approach, lliis alternative, by banning aabestoa friction product* 5 years after promulgation, would strongly encourage the rapid development of additional effective substitutes for asbestos friction product*. The 5-year delayed ben would also allow time for expansion of production capacity (or non-asbestos .
friction products. EPA estimates that this alternative,
assuming current exposure levels, would avoid about 2.100 cancer cases that EPA can quantify while costing about $2.11 billion. This is a cost of about 1.01 million per cancer case avoided.
Because OSHA has proposed lowering the workpiece PEL for asbestos to 0.2 f/cc. EPA also estimated the numbers of cancer cases avoided assuming strict compliance with this lower PEL. Assuming strict compliance with an OSHA PEL of 0.2 f/cc, EPA
estimates that this alternative would avoid about 1.080 cancer cases that EPA can quantify, while coating about $2.11 billion. Thia is cost of about $22)0 million per cancer case avoided.
To determine how sensitive the cost
per cancer cose avoided was to the banning of particular products, EPA conducted a sensitivity analysis, excluding asbestos-cement pipe from the ban.
Without a ben of asbestos-cement pipe and assuming strict compliance
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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 Si.87 billion. This is a cost of about 82.22 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 exemption process for essential uses without substitutes. One area EPA is studying in particular is the aftermarket for asbestos brakes. Some persons have stated that asbestos brakes now in use cannot safely be replaced by asbestosfree brakes when they wear out. while others have disagreed with this assertion. EPA is aware of the potential risk to the public from poorly performing brakes. EPA specifically requests comment on this issue.
EPA considered various approaches for addressing the risk presented by asbestos products not banned either soon after promulgation or 5 years after promulgation under this alternative. One
approach would be to propose and promulgate a rule under section 8(a) of TSCA to gather contemporaneous data concerning the production and use of and exposure to these products at the time the first products ban rule becomes effective or at a date a few years later.
EPA would analyze that data and then decide whether to ban additional
asbestos products. EPA would also determine the date of these bans, which may be at staged intervals. After deciding these issues. EPA would propose and promulgate the bans of these asbestos products. Another approach for addressing the risk presented by these remaining asbestos products is discussed as alternative 2 below.
2. Ban the asbestot construction products category and asbestos clothing soon after promulgation of the rule, ban the asbestos friction products category about 5 years later, and ban remaining asbestos products about 10 years later. Under this alternative, as in alternative 1. EPA would ban the manufacture, importation, and processing of the asbestos construction products category
and asbestos clothing soon after promulgation of the rule, and ban the manufacture, importation, and processing of the asbestos friction products category 5 years after promulgation of the rule. This alternative would also ban the manufacture, importation, and
processing of all other asbestos products 10 years after promulgation of the rule.
This alternative would relatively quickly ban a number of asbestos products for which effective substitutes exist while 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.
As in alternative 1. EPA is considering the need for an exemption process for asbestos friction products in connection with the staged product bans.
EPA estimates that this alternative, assuming current exposure levels, would avoid about 2.120 cancer cases that EPA can quantify white costing about 82.29 billion. This is a cost of about 81.08 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 82.29
billion. This is a cost of about 82.13 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 960 cancer cases that EPA can quantify, while costing about 82.02 billion. This is a cost of about 82.12 million per cancer case avoided.
3, Ban the asbestos construction products category and asbestos clothing soon after promulgation of the rule anu cover all other asbestos products under the phase-down. Under this alternative
EPA would ban the manufacture, importation, and processing of the asbestos construction products category
and asbestos cfothing 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 phase-
down 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 81-00 million per cancer case avoided.
Assuming strict compliance with an OSHA PEL of 0.2 f/cc, EPA estimates
that this alternative would avoid ahn>t* 1.010 cancer cases that EPA can quantify while costing about 82.01 billion. This is a cost of about 81.98 million per cancer case avoided.
Without a ban of asbestos-cement pipe and assuming strict compliance with an OSHA PEL of 02 f/cc. EPA estimates that this alternative would avoid about 950 cancer cases that EPA can quantify while costing about $1.86 billion. This is a cost of about $1.95 million per cancer case avoided.
The following Table VI summarizes the estimated costa and estimated cancer cases avoided that EPA could quantify for the proposal and the three alternatives discussed earlier, first assuming current exposure levels and then assuming strict compliance with an OSHA PEL of 0.2 f/cc
Table VI--Estimated Costs and Cancer Cases avooeo
Aft. 1 Aft. 2 Aft. 3
AMmgCar.nl Ea
Cm (Moral ---------------Conor ooo ooM____
..
S1.SS 1J90
S10S
szn 1100
1 01
8ZJ8 2.120
si os
82 01 2.020
8100
lounaig Sine) CompTco wm m OSHA PEL ol OZI/cc
CM Moral..... Carem ctwi roadad____ Cod pm catcm cam
kmmo maooiai----------
(ISO 1.000
81 .M
tt.11 1.000
tt.00
8228 1.070
82 13
8201 1.010
Si M
Mgnivt i Sy memlot coraructcw product! rod
bwoi aocrog soon PM pronMjiwt rod op hMim
moon oroouett p ywrt.
MpnpP'ii 2 Bin MMtM crodftuetro product! rod
Nbpcoa dodrog toon cftar prorrUgaron, Pro umuoi
mcton product
tro yan.
yrort and tro rrororrog product* r
Aftrowro 3 Bar totPot croamcaro product* rod
atbapoa ctotrog toon aAar prortwwgaton rod couar ramatv
nQ product! rooar tm pftaaa aero.
4. Require labeling of asbestos products subject to a ban. As part of this alternative. EPA also proposes and requests comment on a labeling reguirement In particular, it is proposed that products not immediately banned but subject to regulation S or 10 years from now be labeled in the interim. The labeling would advise purchasers that the product contains asbestos. EPA requests comments on this proposal, in particular on (1) the appropriateness of this proposal for all or some subset of the products in this category; (2) the appropriateness of a simple content
warning as opposed to a more extensive labeling provision; and (3) the extent to which labeling would serve to reduce exposure to asbestos.
EPA also considered a number of alternatives for implementing the phasedown. These include options concerning the following: who would be assigned permits: how persons would be granted
Federal Register / VoL 51. No. 19 / Wednesday. January 29, 1986 f Proposed Rules
3751
permits; whether permits would be transferable, whether permits would be bankable; and how imported products containing asbestos would be treated. EPA also considered a number of options before adopting its current regulatory strategy for controlling the risk from asbestos. These options are discussed in documents which are included in the rulemaking record.
V. Placing of Unreasonable Risk
EPA has weighed the health risks from continued use of asbestos and asbestos-containing products against the
coats attributable to the proposed regulation. EPA has concluded, that the avoidance of about LUO cancer cases that can be quantified assuming current exposure levels, or the 1.000 canoar
cases that can be quantified assuming strict compliance with an OSHA PEL of 0.2 f/cc, many other cancer cases that cannot be quantified, and many cases of asbestos-related disease substantially outweigh the casts to consumers, producers, and users of asbestos products from tbs proposed regulation. Therefore. EPA finds that the continued mining and importation of asbestoa and asbestos products in tbs United States for domestic use and for export present an unreasonable risk to human health. The finding is based on the following points:
1. The health effects from asbestos
exposure are very serious. Asbestos is a demonstrated human carcinogen. The cancers caused by asbestos ore usually fatal and cause much pain and suffering. In sdditioa asbestos causes other lung diseases such as asbestosis.
2. Available evidence supports the conclusion that there Is no safe level of exposure to ssbestos. This conclusion is consistent with present theory of cancer etiology and is further supported by the many documented cases where low or short-term exposure has been shown to cause asbestos-related disease.
3. Models developed to estimate die relative risk of developing cancer from exposure to asbestos show a linear dose-retposse relationship. Based on data from epidemiology studies, these models predict that humans exposed to very low levels of ssbestos incur some risk. Individuals frequently exposed to levels typically found at asbestos
worksites ere estimated to have very high risks of contracting cancer, perhaps greater than 1 in 100.
4. Asbestos fibers are colorless, odorless, and frequently invisible, thus presenting risk to persons not aware that they may be exposed. Asbestos fibers are extremely dormbit and have aerodynamic properties that allow them to remain suspended tn the air for a long
time. Asbestoa fibers easily reenter the atmosphere after settling out and can travel long distances through the air.
5. Health risks from exposure to asbestos fibers during the lifecycle of the asbestos products covered by this proposed rule occur to many 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 population of the U.S. is exposed to asbestos in the air. More than 40000 workers an exposed
during manufacture and processing of asbestos products covered by this proposal. Many additional thousands of workers end consumers are exposed during product installation, use. maintenance, renovation, removal, and disposal of asbestoa products. Finally, many millions of peopla who reside near asbestos worksites are also exposed to significant concentrations of asbestos in the air.
S. Using typical rather than worstcate, data and assumptions. EPA has estimated that this proposed rule banning certain asbestos products end phasing out ell others, if promulgated, would avoid approximately 1.830 cases of cancer which would otherwise result from exposure to asbestos between the years 1965 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 bo 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/cc.
--
________ ^
nr* ^
Hm|| tam
As| M
Cmvcaaw
Qmm ttOJ
1*4
1t
tn m mm
0t 44
These estimates of cancer cases
avoided by the product bans should not be viewed In Isolation, since eebestoe use in other product sectors would theoretically decrease et less then the current rats unless all asbestos use is
phased out 7. Even if OSHA promulgates end
achieves strict compliance with a PEL of 0.2 f/cc almost 1.325 cancers would still result from asbestos products made over
the next 15 years. This nils would avoid about LOGO of those cancer cases.
6. The estimated costs of this
proposed rale are reasonable in view of the number of cancers and other adverse health effects that would be
avoided. Substitutes for asbestos are readily available for many products and can be expected to become available during the phase-down period for most if not all other uses. Even though the
costs are probably overestimated, the coat per cancer case avoided, assuming current exposure levels, that EPA can
quantify, is about SIJOZ million. Even if OSHA promulgates and achieves strict compliance with a PEL of <L2 f/cc the cost per cancer case avoided that EPA can quantify is about SUM million. If all
cancer cases and tbs incidence of other
diseases could be quantified, the cost per case of disease prevented would be substantially lower. In sdditioa the overall costs of the rale are spread over a large population so that the cost to any individual would be negligible. Further, EPA expects substantial savings to result bom tins rale from such factors as avoided coats in treating asbestos related diseases, avoidance of lost productivity caused by these diseases, avoided costs in asbestos removal and disposal and avoidance of litigation coats resulting from ssbestos disease claims.
EPA also finds that the costa of alternatives L 2. end 3 are reasonable in view of the numbers of cancers and other adverse health effects that they would avoid. The costs per cancer case avoided that EPA can quantify of these
alternatives are approximately the seme s for the proposed rale.
As discussed earlier. EPA conducted a sensitivity analysis to see bow sensitive the cost per cancer case avoided by this rale and the cost per cancer avoided by the regulatory alternatives discussed earlier were to the banning of particular product!. Specifically. EPA analyzed the cost per cancer case avoided for the proposal and tha other options excluding ssbestos cement pipe or vinly-asbestoa floor tile from the bans. Even with these relatively high exposure products excluded from the bans, the cost per cancer case avoided by the proposal and the alternatives are similar.
For example, without a ban of asbestoa-cement pipe and assuming strict compliance with an OSHA PEL of (12 f/ec this proposed rale would cost about Si.96 million per cancer case avoided that EPA can quantify. Without a ban of vinyt-eabestos floor tile end assuming strict compliance with an OSHA PEL of 0.2 f/cc, this proposed rule
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would cost about $2.28 million per
cancer case avoided that EPA can
quantify.
*
VL Other EPA Statutes
Section 6(c] of TSCA requires that if EPA determines that a risk of injury to health or the environment could be eliminated or reduced to a sufficient extent by actions taken under another statute administered by EPA. EPA may not promulgate a rule under section 6(a) of TSCA unless EPA finds ft is in the public interest to protect against the risk by action under TSCA. EPA finds that
no other law administered by EPA will eliminate or reduce the risks from asbestos to a sufficient extent
Several EPA statutes have been used to limit asbestos exposure. In 1973. EPA used the authority of the CAA to list
asbestos as a hazardous air pollutant establish a "no visible" emission standard for manufacturers, and ban the use of spray-applied asbestoscontaining material as insulation in buildings, published in the Federal Register of April 6.1973 (38 FR 8828). EPA amended this regulation in 1975 to ban asbestos-containing pipe lagging, by
a rule published in the Federal Register of October 12,1975 (40 FR 48292); and in 1978. extended the ban to all uses of sprsyed-on asbestos by a rule published in the Federal Register of June 19,1978 (43 FR 28372). The CAA rule, which was last amended on April 5,1984 (49 FR
13858), also regulates the removal of asbestos from buildings and the disposal of wastes generated by removal.
However, the CAA has limitations. The CAA does not apply directly to indoor air in the workplace or home. Consequently, any possible additional use of that statute may leave many workplace or home exposure situations inadequately controlled.
Another EPA statute that could be used to limit asbestos exposure is the
Safe Drinking Water Act (SDWA). EPA announced its intention to consider asbestos for inclusion in its proposed National Revised Primary Drinking Water Regulations by a Notice published in the Federal Register of October 5.1983 (48 FR 45502). However, even if the SDWA is used to set a drinking water standard for asbestos, it
would necessarily ignore the inhalation risk associated with asbestos.
An additional EPA statute that could be used to limit asbestos exposure is the Resource Conservation and Recovery Act (RCRA). Under RCRA. EPA could list asbestos as a hazardous waste and subject asbestos waste to general RCRA requirements designed to reduce exposure. However, such action under RCRA would only reduce exposure
during the disposal of asbestos and asbestos products.
VIL Analysis Under Section 9(a) of TSCA
Under section 9(a)(1) of TSCA. the Administrator is required to submit a report to another Federal agency when two determinations are made. ITte first determination is that the Administrator has reasonable basis to conclude that a chemical substance or mixture presents or will present an unreasonable risk of injury to health or the environment The second determination is that the unreasonable risk may be prevented or reduced to a sufficient extent by action taken by another Federal agency under a Federal law not administered by EPA. Section 9(a)(1) provides that where the Administrator makes these two determinations. EPA must provide an opportunity to the other Federal agency to assess the risk described in the report to interpret its own statutory authorities, and to initiate an action under the Federal laws that it administers. Section 9(a) of TSCA thus requires EPA to review other Federal authorities not administered by EPA to determine whether action under those authorities may prevent or sufficiently reduce unreasonable risk. The following unit summarizes past and contemplated action by other agencies and then discusses why those agencies are not able to prevent or sufficiently reduce the unreasonable risk presented by asbestos.
A. Other Authorities Affecting Asbestos
Under the authority of the Consumer Product Safety Act (CPSA. 15 U.S.C. 2051) the CPSC has issued rules banning consumer patching compounds containing respirable asbestos (18 CFR Part 1304) and artificial emberizing materials containing respirable asbestos (18 CFR Part 1305). The CPSC took those actions based on findings that tha use of thoae products in the household would result in increased risk of cancer. Earlier, the Food and Drug Administration under tha Federal Hazardous Substances Act {FHSA. 15 U.S.C. 1281) banned "general-use garments containing asbestos other than garments having a bona fide application for personal protection against thermal injury and so constructed that the asbestos fibers will not become airborne under reasonably foreseeable conditions of use" (18 CFR 1500.17). The FHSA is now administered by the CPSC
In I960. CPSC issued a general order requiring persons to furnish Information on the use of asbestos in certain consumer product categories. CPSC has 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 la 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 4.1963 (48 FR 51088), but the ETS waa found invalid by a court OSHA proposed a revised standard in the Fadenl 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 of 2 f/cc
Possible jurisdiction over other aspects of asbestos risk may lie with still other Federal agencies. For example, the Asbestos Information Association (A1A). commenting before a Senate subcommittee on early versions of TSCA. noted that the Federal Trade Commission may have authority to require labeling, distribution, and marketing of asbestos products and that the Department of Transportation has authority to control transportation of hazardous substances, such as asbestos. 1971 Senate Hearings at 224-227.
State and local public employees are generally excluded from coverage under the OSHAct. However, under section 19 of the OSHAct OSHA has approved State plans for 23 States and two territories, thus effectively extending OSHA protections to State and local public employees in the jurisdictions. EPA has proposed a rule to establish requirements similar to those of the OSHA Asbestos Standard for State and local public employees not under a State plan who conduct asbestos abatement work. However, other public employees, such as firefighters, are not covered by this rule.
B. EPA's Determination Under Section 9(a) of TSCA
EPA is not required to submit a report to other agencies under section 9(a) on the asbestos risks described in this notice since EPA has determined that such risks cannot be prevented or
Federal Register / Vol. 51. No. 19 / Wednesday. January 29. 1986 / Proposed Rules
3753
reduced to a sufficient extent by actions taken under a Federal law not administered by EPA. Certain activities involving asbestos present risks that fall
under the jurisdiction of a number of different Federal laws such as the OSHAct, the Consumer Product Safety Act and the Clean Air Act but no one statute, other than TSCA. can adequately address all ite risks. Referral would result in fragmented assessment
of risks and potentially duplicative regulatory efforts, inefficient control of risk, and an adverse effect on public health. Furthermore, even if EPA were to
refer asbestos risks to other agencies, action taken by those other agencies would still leave a substantial residual risk. EPA's reasons for reaching this conclusion are set forth below.
1. Interpretation ofsection 9(a) of TSCA. The comprehensive nature of TSCA has long been recognized. TSCA allows regulation of a chemical substance based on all its risks and. thereby, allows the Government to remedy the deficiencies in other statutes that can deal only with parts of the risk. (Statement of the President on signing S. 3149 Into Law. October 12.1975, Weekly Compilation of Presidential Documents. voL 12. No. 42. Oct IS. 1978, at 1489; S. Rep. No. 94-898.94th Cong.. 2d Seas, at
2.) The need for a total exposure approach to chemical regulation and the dangers of a fragmented regulatory approach were recognized even during the early congressional hearings on TSCA. See. e.g. 1973 Senate Hearings at 212-214; 1972 House Hearings at 85-87. No other single law provides authority to deal comprehensively with multi-
media hazards.
In particular. Congress designed TSCA to deal with chemical substances
for which the most appropriate remedy would be a total ban on their production and distribution in commerce. In this regard. Congress focused on the risk of asbestos and the dangers of fragmented regulation of asbestos during die
legislative hearings. See 1971 Senate Hearings and 1973 Hearings. Asbestos risks were described in the workpiece and in over 3400 uses that could present risks to the general population. (HJL Rep. No. 94-1341.94th Cong, 2d Sets, at 5 (1978).) Members of Congress believed it intolerable that no agency could deal
comprehensively with chemical risks. Including the risk from asbestos. See 1973 Senate Hearings at 319-320 (Letter from Senator Tunney to Dow Chemical
Company); 197S Senate Hearings at 131133 (Remarks of Senator Tunney).
EPA's decision not to refer the risks associated with asbestos is divided into two parts. First EPA determines that
there is no other Federal authority capable of addressing the combination of activities involving asbestos. Section 9(a) requires EPA to consider the Issues necessary to make this determination because the Agency believes that the combination of asbestos activities, under the jurisdiction of a number of Federal laws, presents an unseasonable
risk. Second. EPA examines the residua) risks that would remain if other agencies were to regulate asbestos and determines that such residual risks would still be unreasonable.
2. Capability of other Federal authorities to deal with the combination of asbestos activities. EPA has concluded that asbestos is a clear example for TSCA action rather than referral to other agencies. It is a substance for which there is broad exposure to populations in numerous situations--in the workplace, through ambient concentrations, and from consumer products. With the exception of TSCA. there is no one unified authority to deal with these multiple exposures. No one of the other potential Federal regulatory authorities, in looking at its specific part of the overall exposures, can either evaluate or deal with the totality of the risk presented. Thus. OSHA may set exposure limits for
workers, but there may be venting of asbestos into the atmosphere; EPA. under the Clean Air Act may regulate ambient emissions, but not workplace or consumer exposures; and in each step of
the process, only a fraction of the risk is evaluated. Only EPA under TSCA may look across the range of asbestos use to evaluate whether it presents'an unreasonable risk. There is no other Act that affords such authority and. accordingly, referral is inappropriate.
EPA's analysis of the jurisdiction over the risks presented by asbestos among a number of agencies and statutory authorities is set out below. OSHA has authority under the OSHAct for risk presented to private sector manufacturing, construction, and service employees from workplace exposures, and may approve State plans covering State and load public employees. CPSC has authority under the CPSA and FHSA concerning risk presented to consumers from consumer products. The Mine Safety and Health Administration
has authority under the Mine Safety and Health Act concerning risk presented v during the mining and milling of asbestos. State and local public employees, such as firefighters who may wear asbestos clothing, in about half the States are not covered even indirectly by OSHA regulations and are subject to State authority.
3. Residual risks. Even if other Federal agencies took additional action to reduce the risk associated with asbestos during the various stages of the lifecycle of asbestos products clearly within their jurisdiction, a substantial and unreasonable residual risk would still remain.
Many groups outside of OSHA jurisdiction are at risk from exposure to asbestos. State and local public employees, such as firefighters, are not protected by OSHA regulations in about half the States. The general population
is exposed to asbestos in the ambient air as a result of release during the manufacture, processing, use. repair, and disposal of asbestos products. EPA estimates that about 540 persons will develop cancer as a result of exposure to asbestos in the ambient air as a result of releases associated with products imported or manufactured over the next 15 years.
Even if OSHA promulgates and achieves strict compliance with' a PEL of 02 f/cc. a substantial and unreasonable residual risk would remain. About 1.325 persons would still develop cancer as a result of exposure to asbestos in products imported or manufactured over the next 15 years. These include cancers in populations totally outside of OSHA's jurisdiction. Even with a lower
workplace PEL. EPA estimates that about 540 persons will develop cancer from exposure to asbestos in the ambient air. In addition, at a PEL of 02 f/cc. EPA estimates that about 785 workers under OSHA jurisdiction would develop cancer as a result of workplace exposure to asbestos in products imported or manufactured in the next 15 years.
EPA calculated these figures using well-accepted models. EPA used the Nicholson relative risk model to estimate the number of lung cancer cases and die Nicholson absolute risk model to estimate the number of mesothelioma cases. The dose-response constants used in the risk assessment were those estimated by Selikoff in a study of asbestos insulation workers (Ret. 11). A number of epidemiological studies have estimated dose-response constants for asbestos-related diseases and estimates vary by as much as an order of magnitude. The Selikoff estimates fall approximately in the
middle of the ranges of dose-response estimates for both lung cancer and mesothelioma. In addition, the Selikoff estimates have the lowest variance among all of the estimates. These models and dose response constants were recommended by the CPSC's Chronic Hazard Advisory Panel on
3754
Federal Register / Vol. 51, No. 19 / Wednesday, January 29, 1986 / Proposed Rules
asbestos (Ref. 1) and were also used by OSHA to estimate the risk posed by asbestos in support of the proposed revision of OSHA's asbestos standard.
OSHA* choice of 0.2 f/cc as a proposed PEL was based on the feasibility of measuring asbestos levels in the workplace. At a level of 0.2 f/cc. OSHA. using the same lung cancer and mesothelioma models as EPA. estimates that there would be 670 excess cancer deaths per 100,000 workers exposed over a working career (Ref. 12). In I960, a joint NIOSH/OSHA Asbestos Work Group stated that there was no level of
exposure to asbestos below which clinical effects did not occur and recommended a PEL of 0.1 f/cc based on the limitation of current technologies for measuring air concentrations of asbestos (Ref. 7). Even a level of 0.1 f/cc, OSHA estimates that there could be 336 excess cancer deaths per 100.000 workers exposed over a working career (Ref. 12).
It is likely that a PEL of 0.2 f/cc will be exceeded in many cases since it is particularly difficult to apply tha 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 60 percent of workers exposed to asbestos are in the construction and service sectors. Employees in those sectors often do not know when they are exposed to asbestos because they do not know that they are working with asbestos products. Compliance inspections are also difficult in the construction and service sectors sines employees frequently do not have a fixed worksite. In fact the current PEL of 2.0 f/cc has been exceeded in many cases in these sectors. Thus, it is likely that many workers in the construction and service sectors will develop cancer unless EPA takes action. Finally, many asbestos control measures. In particular, the use of respirators, only put the asbestos exposure problem elsewhere because they do not control the release of large quantities of asbestos to the ambient environment where it continues to present a risk both to other workers end the general population.
Similarly, CPSC cannot evaluate or deal with the totality of the risk presented by asbestos. CPSC may ban or require safety standards for asbestoscontaining consumer products based exclusively on risk to consumers. CPSC is unable to consider risk to other groups from releases of asbestos during the lifecycle of those products.
After carefully analyzing other Federal authorities. EPA concludes that
action under TSCA is appropriate to
reduce the unreasonable risk to human health posed by asbestos. Use of other Federal authorities cannot reduce risk to e reasonable level because (1) 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.
VIIL Provisions of the Propoeed Rule
A. Product Prohibitions
EPA proposes to prohibit the manufacture, importation, and processing of several asbestos products. The prohibitions will take effect at the 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 could 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 all applications. As an alternative. EPA is considering banning these several asbestos products by a date soon after the promulgation of this rule.
& Mining and Import Restrictions
EPA proposes to prohibit the mining or importation of bulk asbestos, and the importation of the asbestos products listed in f 783.145 of the proposaL unless the miner or importer holds a permit issued by EPA allowing mining or importation of that quantity of asbestos. EPA is considering the requirement that products made under the permitting system be labeled as containing asbestos. Labeling would ensure that persons working with or otherwise hiniling the products would know that tha products contained asbestos, and it would enable them to take steps to reduce the likelihood of exposure.
EPA proposes to reduce the amount of asbestos that may be imported or mined in set decrements each year 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 ore 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 covered by this proposal unless the 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 the operation of the rule
considerably and perhaps make it
unworkable.
The proposal defines "import" as "to bring into the customs territory of the United States except for (1) shipment
through the customs territory of the United States for export without any domestic use or processing; or (2) entering the customs territory of the United States as part of a product during normal personal or business activities involving use of the product" Thus,
asbestos that is shipped through the United States far export without any domestic processing or use would no(/be
covered by this proposed rule. The proposed rale also excludes from coverage situations where an item, such as an automobile containing asbestos, travels across the United States border in the course of normal personal or business activities. In addition, asbestos contained in products that are imported in small quantities solely for personal use by consumers would not be covered by the proposal Thus, under this provision an individual could bring an
item such as a consumer appliance containing asbestos into the United States for his or her own use without obtaining a permit EPA believes that any attempt to cover these situations
would maka this nils very complex and difficult to administer. However, EPA specifically requests comment on whether, in view of the serious health hazard posed by asbestos, all asbestos products should be covered by this rule.
This proposal covers mining and importation of asbestos and the importation of specific asbestos products. EPA proposes to define "asbestos" as "the asbestiform varieties of: chrysotile (serpentine); croddolite (riebeckite); amosite (cummingtonitegrunerite); tremolitr, anthophyilite, end actinolite that are mined or milled." EPA requests comment on this definition. Including whether asbestos which has been chemically treated or altered should be included within the definition. EPA also proposes to cover under this phase-down the asbestos contained in a
number of products listed in | 763.145 of this proposal Persons would be allowed to import these products only if they held permits allowing the importation of the-amount of asbestos contained in t!
Federal Register / Vol. 51. No. 19 / Wednesday. January 29, 1966 / Proposed Rules
3755
products. EPA is covering these particular products in this proposal because they represent the largest quantities of asbestos imported as part of products. EPA is proposing to cover asbestos in products because of the risk posed by possible asbestos exposure during use and disposal of the products and to treat domestic producers and importers of these products similarly.
To implement this program. EPA is proposing that importers of listed products estimate the typical asbestos content of the products. To aid those estimates. EPA has ascertained the typical asbestos content of the asbestos
products covered by this proposal. If persons do not know the exact asbestos content of products they import they can rely on the EPA figures to estimate the amount of asbestos they import EPA would allow persons to use an amount other than the EPA figure if they can show that their imported product contains a different amount of asbestos. Such persons would be required to maintain records supporting their determinations of typical asbestos content and would be subject to appropriate enforcement action if EPA discovered that their imported products actually had a higher asbestos content than they estimated. EPA believes that this is a practical way to implement the phase-down of asbestos use.
C Permits to Mine or Import Asbestos
EPA proposes to issue current miners and importers of asbestos permits that would allow those persons to mine or import set amounts of asbestos. The permit would be letters from EPA stating the amount of asbestos that a person may import or mine during each year of the 10-year phase-down period. The "permitted" amount of mining or importation would be a uniform percentage of the average amount of asbestos each person mined or imported yearly during the base period of 1981. 1962. and 1963. The "permitted" amount of asbestos would be 30 percent of the person's average baae year volumes during the first year of the phase-down period and would decline to 27 percent of average base year volumes during the second year. 24 percent during the third year and so on until it reached 3 percent in year 10. EPA chose these "permitted" amounts based on projections of future asbestos use after analysis of current
use trends, publicly available information on asbestos use. and information reported under the section 6(a) asbestos reporting rule. In addition, the "permitted" amounts chosen reflect the EPA has proposed to ban certain high volume uses of asbestos where suitable substitute products are avilable.
Persons would apply to EPA for permits, listing in their applications their
mining or import volumes during those years. Persons who do not apply for permits would not be granted any. EPA would compare volume information included in applications with information reported under the section
8(a) asbestos reporting rule, which covered 1961. Uniteg States Customs Service data, and Bureau of Mines data. Persons who include false information
in their application would be subject to enforcement action, including criminal prosecution in appropriate cases.
EPA would similarly cover importers
of asbestos contained in the products listed in this rule. Those persons would apply for permits, including in their application the total amount of asbestos in their imported products during the base years 1961.1962. and 1963. 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's 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 permits based on the correct base years' volume information.
Persons would be allowed to transfer their permission to mine or import asbestos to other persons, including
persons who were not issued permits by EPA. Permits issued to miners, importers of bulk asbestos, and importers of
asbestos in products would be interchangeable. Persons could transfer all or only part of their yearly permitted amount to one person or a number of persons. Persons transferring all of part of their permitted amount would be required to report each transfer to EPA.
Persons would also be allowed to reserve or "bank" pennisison to import asbestos during any year of the phasedown period for use during any later year of the phase-down period. Persons would be required to report each "banking" of asbestos permits to EPA. A person who banks permission to mine or import a certain amount of asbestos would be allowed to use only part of
that amount during later years of the phase-down period. The amount of asbestos mining or importation permitted by banked permits would
decline yearly at a rate of 10 percent. Permits not used by the conclusion of the 10-year phase-down period would no longer permit the holder to import or
mine asbestos in any quantity and would have no value of any kind for any
purpose. EPA is considering an alternative of
having banked permits not decline in value. This alternative would provide greater incentive for the banking of . permits and thus incentive for greater reductions in asbestos mining and importation in early years of the phasedown period.
Under the proposed approach, at the end of the 10-year phase-down period, all mining or importation of asbestos would be banned except that allowed under an exemption procedure. EPA would consider applications for exemptions and grant them for essential uses of asbestos for which substitutes are not available, in addition. EPA is considering a requirement that products not banned be labeled as containing asbestos. This requirement could be imposed as part of this rulemaking or by a separate rulemaking.
As an alternative. EPA is considering allowing a residual amount of asbestos mining and importation after the 10-year phase-down period. This genera) approach would avoid the potentially heavy administrative burden and expense of an exemption process. As part of this alternative. EPA is considering allowing permits banked during the 10-year phase-down period to continue to be used during the later period when a much smaller percentage of base years volume is permitted. Such an approach would provide additional incentive for the banking of permits and thus additional incentive for greater reductions in asbestos mining and importation during early years of the phase-down period.
EPA specifically requests comment on this series of alternatives to a ban with an exemption process after the 10-year phase-down period.
D. Reporting
EPA proposes to require persons to report die amount of asbestos imported during each import transaction. EPA specifically requests comment on whether this report should be sent directly to EPA or whether persons should turn the report over to the United States Customs Service, which would forward the report to EPA. Requiring the report to be turned over to the Customs Service as part of each import transaction may facilitate enforcement of the rule.
The proposal also would require persons to report to EPA each transfer of permission to mine or import asbestos. This reporting would be undpr authority of section 6(a) of TSCA and
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would apply to all importers, including small businesses. Section 8(a) exempts small businesses from reporting in certain cases. However. EPA may require miners and importers of a substance subject to a rule under section 8 of TSCA to report. Since asbestos is already subject to rules under section 8 and would be subject to this one, the small business exemption of section 8(a) would not apply. EPA believes that these reporting requirements represent very little burden and are necessary for effective enforcement of the phase-down rule. EPA would use the information in these reports to maintain a computerized record of the quantities of asbestos each person is permitted to mine or import as compared to the actual level of mining or importation. EPA would investigate cases where the quantity of asbestos mined or imported appears to exceed the quantity of asbestos that a person is permitted to mine or import and take appropriate enforcement action for any violation of the phase-down rule.
To facilitate the transfer of permits, EPA is considering making readily available to interested parties information concerning the persons holding permits and the quantities they hold. EPA may allow persons computer access to an EPA data bank if this would not reveal confidential business information. EPA specifically requests comment on whether EPA should facilitate the transfer of permits and on ways for EPA to accomplish this without revealing confidential business information.
. Recordkeeping
EPA proposes to require persons to retain documentation of information concerning all transfers of permission to mine or import asbestos and the amount of asbestos mined or imported each year. The proposal would require these records to be kept for 5 years after the end of the last year of the phase-down period covered by the rule. Importers of asbestos contained in products covered by this proposal would also have to keep records concerning their levels of importation. EPA believes that these recordkeeping provisions would be essential to enforcement of this proposed rule.
IX. Enforcement
Section 15 of TSCA makes it unlawful to fail or refuse to comply with any provision of a rule promulgated under section 6 of TSCA. Therefore, any failure to comply with this proposed rule when it becomes effective would be a violation of section 15 of TSCA. In addition, section 15 of TSCA makes it
unlawful for any person to: (1) Fail or refiiae to establish and maintain records as required by this rule (2) fail or refuse to permit access to or copying of records, as required by TSCA: or (3) fsil or refuse to permit entry or inspection as required by section 11 of TSCA. .
Violators may be subject to both civil and criminal liability. Under the penalty provisiqn of section 18 of TSCA. any person who violetes section 15 could be subject to a civil penalty of up to S25.000 for each violation. Each day of operation in violation of this rule when it becomes effective could constitute a separate violation. Knowing or willful violations of this rule when it becomes effective could lead to the imposition of criminal penalties of up to $25,000 for each day of violation and imprisonment for up to 1 year. In addition, other remedies are. available to EPA under sections 7 and 17 of TSCA. such as seeking an injocbon to restrain violations of this rule when it becomes effective and seizing any chemical substance or mixture manufactured or imported in violation of this rule when it becomes effective.
Individuals, as well as corporations, could be 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 if 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 disdose 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.
XL Rulemaking Record
EPA has established a record for this rulemaking (docket control number OPTS--82040). A public version of the
record, without any confidential business information, is available in the Office of Toxic Substances Public Information Office, from 8 a.m. to 4 pm.. Monday through Friday, except legal holidays. The Public Information Office is located in Rm. E-107,401M St, SW,, Washington, D.C
The record includes information considered by EPA in developing this proposed rule. EPA will supplement the record with additions! information as it is received. The record now includes the following categories of information: (1) Federal Register notices, (2) support documents, (3) reports, and (4) memoranda and letters.
EPA will identify the complete
rulemaking record by date of promulgation. EPA will accept additional material far inclusion in the record at any time between this notice and designation of the complete record. The final rule will also permit person# to point out any errors or omissions in the record.
XU. References
(1) USCPSC Report to the U.S. Consumer Product Safety Commission by the Chronic Hesard Advisory Panel on Asbestos. July 1083-
(2) USEPA OPTS. OTS. Exposure Assessment for Asbestos. Draft (anuary 8. 1864.
(3) USEPA. OPTS. OTS. Regulatory Impact Analysis of Controls on Asbestos tnd Asbestos Products. January 1986.
(4) USEPA OPIS. OTS. Support Document for Final Rule on Friable Asbestos-Containing Materials in School Buildings--Health Effects and Magnitude of Exposure. January. 1982.
(5) National Research Council. "Asbestos" hr. "Drinking Water and Health." VoL 3. National Academy Pleas. Washington. D.C (1882): 223-283.
(8) NaUontl Research Council. "Nonoccupational Health Risks of Asbesttfonn Fibers." National Academy Press. Washington. D.C (1884).
(7) NIOSH-OSHA Asbestos Work Croup. Workplace Exposure to Asbestos: "Review and Recommendations" DHHS (NIOSH) Publication No. 81-103, US. Government Printing Office, Waahington, D.C 20402.
(1980). (8) OSHA "Quantitative Risk Analysis for
Aabeatoe-Related Cancan: A Preliminary Report." (1883).
(8) Seidman. H. SelikofT. L).. Hammond. EC.. "Short-Terra Asbestos Work Exposure end Long-Term Observation.' Annals of ike New York Academy of Science. 330 (1979): 81-89.
(10) SelikofT. I.J_ Anderson. H.A. Seidman. H. "Asbestos Disease Among Household Contacts of Asbestos Worken" In: "Disability Compensation for AsbestosAssociated Disease in the U.S_" edited by l.|. SelikofT. Environmental Sciences Laboratory. Mount Sinai School of Medicine of the City University of New York. (1982): 73-78.
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(11| Sclikoff. 14- HimaondL EC., Seidman H, "Mortality Expontnca of Insulation Workan in tha U-S. and Canada. 1943-1B7B." Arutalt of the New York Academy ofScience. 330 (1979): 91-111
(12) USDOL OSHA "Occupational Exposure to Asbestos: Emergency Temporary Standard.' (November 11983:48 FR 51088).
(13) USDOL OSHA. "Occupational Exposure to Asbestos. Proposed Rule and Notice of Hearing* (April 101984:49 FR 14118).
(14) USEPA. opts: OTS. Asbestos Substitutes and Related Materials. April 24. 1985.
XHL Regulatory Assessment Requirements
A. Executive Order 12281
Under Executive Order 12291. EPA has determined that this proposed rale ia a "Major Rule" and has developed an R1A. The RLA estimates that this proposed rale would cost about SUM billion over IS yean. However, the RIA also estimated that this proposed rale, if promulgated, would avoid approximately 1.930 cases of cancer. As shown in Unit V above. EPA believes that these coats an reasonable and that this proposed action is a cost-effective way of reducing the unreasonable risks related to asbestos.
This proposed rale was submitted to the Office of Management and Budget (OMB) for review as required by Executive Order 12291.
B. Regulatory Flexibility Act
EPA has analyzed the economic imped of this proposed rale on small businesses. A summary of EPA's analysis appears ia Unit HL
C. Paperwork Reduction Act
The reporting and recordkeeping provisions in this proposed rale will be submitted to the Office of Management and Budget (OMB) for approval under the Paperwork Reduction Act Comments on these requirements should be submitted to the Office of Information and Regulatory Affairs at OMB and marked Attention: Desk Officer for EPA. Any final rule will explain EPA's response to OMB and public comments on the proposed reporting and recordkeeping requirements.
List of Subjects In 40 CFR Part 70
Environmental protection. Hazardous substances. Recordkeeping and reporting requirements. Asbestos.
Dated: Januxry 22.1988. Lee M. Thomas.
Adminittmtor.
PART 703--(Amended1
Therefore, it is proposed that 40 CFR' Part 783 be amended as follows:
L. The authority citation for Part 783 is revised to read as follows:
Authority: 15 US.C. 2805 and 2807(c).
2. By adding new Subpart H to read as follows:
wBApaaviit Sr-Sp^Ms -sB. --tnov fteetrtctione
w-- iq* wyui I
Sec. 783.140 Scope. 783.143 Definitions. 783.145 Mining and Impost restrictions. 783.147 Permits to mine or impact asbestos. 783.148 Iseoenco of permits. 783.149 Appeals concerning permits.
783.150 Transfer of permits 783.151 Wewlriwg of permits. 783.153 Recordkeeping.
783.154 Reporting. 783.158 Enforcement 783.157 Inspections 783.150 Confidentiality and public aeons to
information.
Subpart H--Agfattoo Mining and Import Restrictions.
1783.140 Scope.
This Subpart prohibits the mining or importation of asbestos, including asbestos in certain asbestos products, unless authorized by a permit issued by EPA.
1783.143 DeflnMona.
The definitions in section 3 of TSCA. IS U.S.C. 2802, apply to this Subpart. In addition, the following definitions apply:
(a) The terms "act" "article,'' "byproduct" "customs territory of the United States." "EPA." "importer." "manufacturer." "persons." and "United States" have the same meanings as in 1720-3 of this chapter.
(b) "Asbestos" means the asbestiform varieties of: chrysotile (serpentine): croddolite (riebeckite); amosite, (cummingtonite-granerite); tremollte: anthophyllite, and actinoUte that are mined or milled.
(c) "Asbestos product" means any mixture or article containing asbestos.
(d) "Consumer" means a natural person who uses a product for personal rather than business purposes.
(e) "Import" means to bring into customs territory of the United States for any purpose except (1) for shipment through the customs territory of the United States for export without any domestic use or processing: or
(2) entering the customs territory of the United States as part of a product
during normal personal or business activities involving use of the product.
(f) "Milled" means the separation of asbestos fibers from asbestos ore. the grading and sorting of asbestos fibers, or the fiberizing of asbestos ore.
(g) "Mine" means to produce asbestos other than as an unintended contaminant or impurity by extracting asbestos-containing ore so that the ore may be (1) distributed in commerce or (2) milled for distribution in commerce.
(h) "Miner" means a person who mines asbestos.
{783.144 Mating and Import restrictions.
(a) Beginning the first day of the calendar year after this rale becomes effective, or if this rale becomes effective during the last 4 months of a calendar year, beginning the first day of the second calendar year after this rale becomes effective, no person other than a person authorized by a permit issued by EPA as provided in this part may:
(1) Mine asbestos in the United States or
(2) Import asbestos, including asbestos in an asbestos product listed in this section, except in small quantities solely for personal consumer use. into the customs territory of the United States.
(b) The following asbestos products may not be imported into the customs territory of the United States except ia small quantities by a consumer solely for his or her personal use unless authorized by a permit issued by EPA as provided in this Subpart
(1) Appliances. (2) Pipeline wrap. (3J Thread, yam. lap. roving, cord, rope, or wick. (4) Sheet gasketing, rubber encapsulated compressed. (5) Disc brake pads (light-medium vehicles). (8) Cloth, other then asbestos clothing. (7) Brake blocks. (8) Millboard. (9) Packing. (10) Mixed or repackaged asbestos fiber.
(11) Thermoplugs. (12) Tape. (13) Roof coatings. (14) Clutch facings. (15) Automotive gasket kit (10) Dram brake linings. (17) Yam. (18) Automobiles and other motor vehicles.
1783.147 Permits to mine or Import M0MtOC
(a) Persons may mine in the United States or import into the customs
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Fedeial Register / Vo!. 51. No. 19 / Wednesday, January 29, 1986 / Proposed Rules
territory of the United States only the quantity of asbestos for which they hold permits issued under this Subpart
(b) The amount of asbestos contained in imported product listed in | 763.145 will count toward the total amount of asbestos a person may mine or import during a year.
(c) Persons must estimate typical asbestos content of imported asbestos products covered by this rule. Persons may use EPA's estimate of typical asbestos content if they, are not certain of the typical asbestos content of a product.
f 7*3.144 Issuance of permits.
(a) (1) EPA will issue permits for the mining or import of asbestos, including asbestos contained in the asbestos products listed in | 763.145.
(2) Applications for permits must be sent to the Office of Toxic Substances (TS-792). EPA, 401 M St.. SW.. Washington, D C 20460.
(b) (1) Persons must apply to EPA for permits by 30 days after the effective date of this rule.
(2) Persons must list in their application for permits the amount of asbestos, including-asbestos contained in the asbestos products listed in i 763.145. that they imported or mined during 1981. 1982. and 1983.
(c) If an application is mailed to EPA. the application must be postmarked by 30 days after the effective date of this rule.
(d) EPA will allocate to persons who apply for permits a uniform percentage of the amount of asbestos those persons reported mining or importing during 1981.1982. and 1983.
(e) Each permit will allow a person to mine or import the following percentages of the average amount of asbestos he or she mined or imported yearly during 1981.1982. and 1983.
Year 1--30 percent. Year 2--27 percent. Year 3--24 percent. Year 4--21 percent. Year 5--18 percent. Year 6--15 percent Year 7--12 percent. Year 8--9 percent Year 9--8 percent Year 10--3 percent
1783. tat Appeals concerning permits.
(a) A person may appeal EPA's initial disposition of his or her application for a permit.
(b) The person must appeal in writing to the Director of the Office of Toxic Substances (TS-792), EPA. 401 M St, SW.. Washington. DC 20480. within 20 days after receipt of EPA's announcement of the disposition of his
or her application. If the appeal ia mailed, the letter must be postmarked within 20 days after receipt of EPA's announcement of disposition.
(c) A person must indicate in an appeal why he or she should receive a permit or be allowed to mine or import additional asbestos under the permit.
(d) The Director of the EPA Office of Toxic Substances will either grant or deny the appeal within 60 days after its receipt. The disposition of the appeal will be announced by letter to the person making the appeal.
1783.150 Transfer of permits.
(a) A person issued a permit by EPA to mine or import a quantity of asbestos may transfer that permit in whole or in part to another person.
(b) A person who transfers a permit to mine or import a quantity of asbestos and a person who receives such a transferred permit mutt report that transfer to the Office of Toxic Substances (TS-792). EPA. 401M SU SW.. Washington. DC 20460, within 10 days of the transfer.
(c) The parties involved in a transfer may report either jointly or separately.
(d) If a report is mailed to EPA. the report must be postmarked within 10 days of the transfer.
f 783.151 Banking of permits.
(a) Persons issued permits by EPA to mine or import a quantity of asbestos during 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-vear phase-down period.
(b) The amount of asbestos that a person it permitted to mine or import will decline horn year to year when it ia reserved or "banked" at a rate of 10 percent per year.
(c) A person who "banks" a permit in whole or in part must report that "banking" to the Office of Toxic Substances (TS-792), EPA, 401 M St SW- Washington, DC 20480. within 80 days of the end of the year for which the permit was issued.
(d) If a report ia mailed to EPA. the report must be postmarked within 80 days of the end of the year for which the "banked" permit was issued.
1783.153 Recordkeeping.
(a) Any person who mines or imports asbestos or any asbestos product listed in f 763.145 must retain in one location documentation of information Showing;
(1) The name of any person to whom he or-she transferred permission to mine or import asbestos.
(2) The name of any person from whom he or she received permission to mine or import asbestos.
(3) The amount of asbestos mined or Imported each year, including asbestos imported in any asbestos product listed in | 763.145.
(4) The typical asbestos content of any asbestos product listed in | 783.145.
(5) The number of individual asbestos products listed in 1763.145 imported each year.
(b) This information must be retained for 5 years from the end of the last year of the 10-year phase-down period covered by this rule.
(763.154 Waportlng.
(a) Any person who imports asbestos,
including asbestos in an asbestos
product listed in 1783.145. must report
to the Office of Toxic Substances (TS-
792). EPA. 401 M. SL SW- Washington.
DC 2046a within 2 day* of the day of
import indicating;
(1) The person's name.
(2) The amount of asbestos imported.
(3) The number of individual asbestpg
products listed in i 783.145 imported.
(4) A certification that the person was
either issued a permit by EPA to import
at least that amount of asbestos that
year or obtained that permission from
another person as provided in f 783.148.
(b) Within 60 days of the end of each
year covered by this Subpart each
person who mines or imports asbestos
including asbestos in an asbestos
product listed in (783.145 must report to
the Office of Toxic Substances (TS-792),
EPA. 401 M. St.. SW- Washington, DC
20480;
(1) The total amount of bulk asbestos
that person mined or imported that year.
(2) The total amount of asbestos that
person imported in asb'itos products
listed in (763.145 that year.
(3) The number of individual asbestos
products listed in (783.145 that person
imported that year.
d
(4) The amount of asbestos that
person had permission to mine or import
that year.
(c) If a report ia mailed to EPA. the
report must be postmarked within 80
days of the end of each year covered by
this Subpart.
(763.158 Enforcement
(a) Failure to comply with any provision of this Subpart ia a violation of section 15 of the Act (15 U.S.C. 2814).
(b) Failure or refusal to establish and maintain records or to permit access to or copying of records, ai required by the Act. is a violation of section 15 of the Act (15 U.S.C. 2614).
(c) Failure or refusal to permit entry or inspection as required by section 11 of the Act (15 U.S.C. 2810) is a violation of section 15 of the Act (15 U.S.C 2814).
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(d) Violator* may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.G 2615) for each violation.
(e) EPA may seek to enjoin the mining or import of asbestos or asbestos products in violation of this Subpart or act to seize any asbestos or asbestos products in violation of this Subpart, or take other actions under the authority of section 7 or 17 of the Act (15 U.S.C. 2606 or 2616).
1769.157 Inspection*.
EPA will conduct inspections under section 11 of the Act (15 U.S.C. 2610) to ensure compliance with this Subpart and to verify that information submitted to EPA under this Subpart is correct.
1763.156 Cenfldentiatity and puMe access to Monnation.
(a) A person may assert a claim of confidentiality for any information he or
she submits to EPA under this Subpart. (b) Any claim of confidentiality must
accompany the information when it is submitted to EPA.
(c) EPA will disclose information subject to a claim of confidentiality asserted under this section only to the extent permitted by TSCA and Part 2 of this title.
(d) If a person does not assert a claim of confidentiality for information at the time it is submitted to EPA. EPA may make the information public without further notice to that person.
3. By adding new Subpart I to read as follows:
Support I--Prohibition of the Manufacture,
Processing, snd Distribution In Commerce ot Certain Asbestos-Containing Products
See. 783-100 783.163
783-165
783.167 763-168
Scop* Definition*
Manufacture--prohibition* ftocessing--prohibition* Enforcement
Subpart l--Prohibition of trie Manufacture. Processing, and Distribution In Commsrcs of Certain Aabaatoa-Contalnlng Products
1763.160 loop*
This Subpart prohibits the manufacture, importation and
processing. of the following categories of asbestos-containing products: asbestoscontaining roofing felt, asbestos- , containing flooring felt (including vinyl sheet flooring backed with flooring felt), vinyl-asbestos floor tile and asbestoscement pipe and fittings and asbestos clothing.
(763.163 Definition*
The definitions in section 3 of the -Toxic Substances Control Act and the following definitions apply to this subpart.
(a) "Asbestos" means the asbestiform varieties of: chryaotile (serpentine): crocidolite (riebeckite): amoeite (cummingtonite-gnmerite); tramolite; anthophyllite. and actinoUte.
(b) "Asbestos-cement pipe and fittings" means an asbestos-containing product that contains cement and it intended to transmit water or sewage; for use at conduit pips for the protection of electrical or telephone cable; or for use as air ducts.
(c) "Asbestos clothing" means an asbestos-containing product made of cloth and designed to be worn by individuals.
(d) "Asbestos-containing product" means any material which contains more than 1.0 percent asbestos by weight
(e) "Flooring felt" means an asbestoscontaining product made of paper felt and intended as an underlayment for floor coverings, or to be bonded to the underside of vinyl sheet flooring.
(f) "Roofing felt" means an aabestoscontaining product mads of paper felt and intended for uae on building roofs as a covering or underlayment for other roof coverings.
(g) "Vinyl-asbestos floor tile" means an asbestos-containing product composed of vinyl resin* containing filler* stabilizer* and pigments and used as floor tHe.
(763.166 Manufacture proltibIMon*
Beginning the first day of the calendar year after this rule becomes effective, or if this rule becomes effective during the last 4 months of a calendar year, beginning the first day of the second calender year after this nils becomes effective, no person shall manufectise
or import the following asbestoscontaining products either for use in the United States or for export* asbestoscontaining roofing felt asbestoscontaining flooring felt (including vinyl sheet flooring backed with flooring felt), vinyi-aabestos floor tile, asbestoscement pipe and fittings, and asbestos clothing.
(763.167 Processing prohibition*
Beginning the first day of the calendar year after this rule becomes effective, or if this rule becomes effective during the last 4 months of a calendar year, beginning the first day of the second calendar year after this rale becomes effective, no person shall process the following product* either for use in the United States or for export asbestoscontaining roofing felt, asbestoscontaining flooring felt (including vinyl sheet flooring backed with flooring felt), vinyl-asbestos floor tile, asbestoscement pipe and fittings, and asbestos clothing.
(763.166 Enforcement
(a) Failure to comply with any provision of this Subpart it a violation of section 15 of the Act (15 U.S.C. 2614).
(b) Failure or refusal to establish and maintain records or to permit access to or copying of record* as required by the Act is a violation of section 15 of the Act (15 U.S.C. 2614).
(c) Failure or refusal to permit entry or inspection as required by section 11 of the Act (15 U.S.C. 2810) is a violation of section 15 of the Act (15 U.S.C. 2614).
(d) Violators may be subject to the civil end criminal penalties in section 16 of the Act (15 U.S.C. 2615) for each violation.
(e) EPA may seek to enjoin the manufacture or import of asbestos products in violation of this Subpart, or act to seize any aabestos products in violation of this Subpart or take other actions under tha authority of taction 7 or 17 of the Act (15 U.S.C. 2806 or 2616).
[FR Doc 86-1881 Filed 1-28-68: 6c4S em|
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