performance in school, ability to make friends, and quality of the
child's life because early disabilities can have compounding effects as
they grow into adulthood. The parent may need to take off work
unexpectedly and have the additional cost of doctor visits and/or
medication.
    For a person whose trigeminal nerve is affected, there is an
emotional and mental toll as they wonder what is wrong and visit
doctors in order to determine a diagnosis. Depending on the severity of
the impact to the nerve, they may be unable to work. Doctor visits and
any inability to work will have a monetary impact to the person. There
are varying costs (emotional, monetary, and impacts to a person's
quality of life) from the neurotoxic effects due to TCE exposure.
However, while neither the precise reduction in individual risk of
developing this disorder from reducing TCE exposure or the total number
of cases avoided can be estimated, this is not a reason to disregard
their impact.
    6. Liver toxicity. The TCE risk assessment identified liver
toxicity as an adverse effect of chronic TCE exposure. There are
increased health risks for liver toxicity to the approximately 2,670 to
6,270 workers and 42,720 to 100,320 occupational bystanders exposed to
TCE as a result of vapor degreasing operations (Ref. 2).
    Specific effects to the liver can include increased liver weight,
increase in DNA synthesis (transient), enlarged hepatocytes, enlarged
nuclei, and peroxisome proliferation (Ref. 2). In addition, workers
exposed to TCE have shown hepatitis accompanying immune[hyphen]related
generalized skin diseases, jaundice, hepatomegaly, hepatosplenomegaly,
and liver failure (Ref. 2).
    Some form of liver disease impacts at least 30 million people, or 1
in 10 Americans (Ref. 55). Included in this number is at least 20% of
those with nonalcoholic fatty liver disease (NAFLD) (Ref. 55). NAFLD
tends to impact people who are overweight/obese or have diabetes.
However, an estimated 25% do not have any risk factors (Ref. 55). The
danger of NAFLD is that it can cause the liver to swell, which may
result in cirrhosis over time and could even lead to liver cancer or
failure (Ref. 55). The most common known causes to this disease burden
are attributable to alcoholism and viral infections, such as hepatitis
A, B, and C. In 2013, there were 1,781 reported acute cases of viral
hepatitis A and the estimated actual cases were 3,500 (Ref. 56). For
hepatitis B in 2013 there were 3,050 reported acute cases, while the
estimated actual incidence was 19,800, and the estimated chronic cases
in the United States is between 700,000 to 1.4 million (Ref. 56). For
hepatitis C, in 2013 there were 2,138 reported cases; however, the
estimated incidence was 29,700 and the estimated number of chronic
cases is between 2.7 to 3.9 million (Ref. 56). These known
environmental risk factors of hepatitis infection may result in
increased susceptibility of individuals exposed to organic chemicals.
While the incidences in this paragraph reflect adverse health outcomes
beyond just exposure to TCE, the general population numbers provide a
context for understanding the impact of the adverse health effects that
TCE can cause.
    Effects from TCE exposure to the liver can occur quickly. Liver
weight increase has occurred in mice after as little as 2 days of
inhalation exposure (Ref. 4). Human case reports from eight countries
indicated symptoms of hepatitis, hepatomegaly and elevated liver
function enzymes, and in rare cases, acute liver failure developed
within as little as 2-5 weeks of initial exposure to TCE (Ref. 4).
    Chronic exposure to TCE can also lead to liver cancer. There is
strong epidemiological data that reported an association between TCE
exposure and the onset of various cancers, including liver cancer. The
estimated value of the annualized benefit is estimated to be $21
million to $133 million at 3% and $11 million to $71 million at 7% over
20 years.
    Additional medical and emotional costs are associated with non-
cancer liver toxicity from TCE exposure, although they cannot be
quantified. These costs include doctor and hospital visits and
medication costs. In some cases, the ability to work can be affected,
which in turn impacts the ability to get proper ongoing medical care.
Liver toxicity can lead to jaundice, weakness, fatigue, weight loss,
nausea, vomiting, abdominal pain, impaired metabolism, and liver
disease. Symptoms of jaundice include yellow or itchy skin and a
yellowing of the whites of the eye, and a pale stool and dark urine.
These symptoms can create a heightened emotional state as a person
tries to determine what is wrong with them.
    Depending upon the severity of the jaundice, treatments can range
significantly. Simple treatment may involve avoiding exposure to the
TCE; however, this may impact a person's ability to continue to work.
In severe cases, the liver toxicity can lead to liver failure, which
can result in the need for a liver transplant, if a donor is available.
Liver transplantation is expensive (with an estimated cost of $575,000)
and there are countervailing risks for this type of treatment (Ref.
57). The mental and emotional toll on an individual and their family as
they try to determine the cause of sickness and possibly experience an
inability to work, as well as the potential monetary cost of medical
treatment required to regain health are significant.

D. Availability of Alternatives

    TCE is commonly used in vapor degreasing systems for a variety of
reasons. It is able to dissolve the greases, fats, oils, waxes, resins,
gums and rosin fluxes generally used in metalworking operations and it
is compatible with most metal substrates. TCE is non-flammable and it
has a relatively low boiling point. It is also available at a
relatively low cost. Several SERs providing input to the SBAR Panel
convened in support of this rulemaking noted that TCE is particularly
well-suited for use in vapor degreasing in the narrow tube, razor
blade, and aerospace industries (Ref. 32).
    Nevertheless, EPA identified a wide variety of technically and
economically feasible alternatives for vapor degreasing with TCE. See
Unit 4 of the Economic Analysis for a complete discussion of the
technically and economically feasible alternatives to TCE. (Ref. 3).
While some substitutes, such as methylene chloride or 1-BP, also
present risks to workers, there are numerous other solvents available.
These include designer solvents such as hydrofluorocarbon (HFC) and
hydrofluoroether (HFE) solvent blends and hydrofluoroolefin (HFO), as
well as other alternative solvents and cleaning systems, such as
terpene-based cleaners, volatile methyl siloxanes, soy-based cleaners,
and water-based cleaners.
    Alternatives to TCE fall within several broad categories: Drop-in
solvent alternatives, non-drop-in solvent alternatives (designer
solvents, such as

hydrofluorocarbons, hydrofluoroolefins, and hydrofluoroethers), aqueous
cleaning systems, other cleaning solvents (such as glycol ethers,
siloxanes, terpenes, soy-based cleaners), and cold cleaning with TCE
(Ref. 58).
    EPA considered a solvent to be a drop-in alternative if it could be
used in an existing vapor degreasing system with only minor
modifications. One important consideration for many vapor degreasing
machines is the flammability of the solvent. Heating a flammable
solvent up to its boiling point increases the likelihood that, if there
is a source of ignition or if the vapor concentration exceeds certain
limits, the solvent will ignite or explode. Halogens (fluorine,
chlorine and bromine) suppress flammability, hence their common use as
fire extinguishants. For this reason, halogenated solvents are commonly
used in vapor degreasing, although solvent flammability is less of a
concern in closed-loop systems operated under vacuum. Depending on the
type of vapor degreasing system, the drop-in solvent alternatives
identified by EPA include methylene chloride, 1-bromopropane (1-BP or
n-propyl bromide), and perchloroethylene. Like TCE, methylene chloride
and perchloroethylene are hazardous air pollutants (HAPs) under the
Clean Air Act and their use is regulated under the Halogenated Solvent
NESHAP (40 CFR part 63, subpart T). Therefore, facilities that switch
from TCE to methylene chloride or perchloroethylene will still be
regulated by the NESHAP. In addition, although 1-BP is not currently
listed as a HAP, EPA is currently considering a petition to list this
chemical (Ref. 59).
    There are significant hazards associated with all three of these
drop-in replacements for TCE in vapor degreasing systems. However,
based on EPA's analysis, the adverse effects associated with TCE
exposure occur at exposure levels below the levels at which the adverse
effects associated with the replacement chemicals occur (Ref. 58). With
respect to methylene chloride, in August 2014, EPA issued a risk
assessment of its use for paint and coating removal and EPA intends to
issue a proposal to regulate this use of methylene chloride. While EPA
has not specifically assessed the risks associated with using methylene
chloride in vapor degreasing applications for this rulemaking, there
are a number of hazard concerns associated with this chemical. The
potential effects of methylene chloride exposure include death, liver
toxicity, kidney toxicity, reproductive toxicity, specific cognitive
impacts, and cancer (Ref. 60). Some of these effects result from a very
short, acute exposure; others follow years of occupational exposure.
Acute exposures may cause confusion and respiratory suppression in
humans and there have been a number of deaths associated with worker
exposures in homes and other job sites due to the buildup of carbon
monoxide in the blood. Methylene chloride is likely to be carcinogenic
in humans, so chronic exposures may increase cancer risk. Chronic
exposures to methylene chloride may also lead to liver effects.
However, these adverse effects are generally seen at higher exposure
levels than those associated with TCE toxicity.
    With respect to environmental effects, methylene chloride is
volatile and releases of methylene chloride are likely to evaporate to
the atmosphere, or if released to soil, migrate to groundwater (Ref.
59). It has a global warming potential (GWP) of 8.7 relative to carbon
dioxide and thus can act as a greenhouse gas. Methylene chloride has
been shown to biodegrade over a range of rates and conditions and is
considered to be moderately persistent in the environment. Measured
bioconcentration factors suggest that its bioconcentration potential is
low.
    EPA also has concerns for 1-BP. In May of 2016, a peer review
meeting was held on EPA's draft TSCA Work Plan Chemical Risk Assessment
for 1-BP. This draft assessment specifically evaluated the risks
associated with the use of 1-BP in vapor degreasing (Ref. 61).
According to the peer review draft, most acute exposure scenarios for
vapor degreasing identified risks for adverse developmental effects
that may occur as a result of a single exposure to 1-BP during a
critical window of susceptibility. Likewise, chronic exposure risks for
adverse neurological and developmental effects were identified in the
draft risk assessment for all uses evaluated without engineering
controls. In addition, the draft weight-of-evidence analysis for the
cancer endpoint is sufficient to support a probable mutagenic mode of
action for 1-BP carcinogenesis. However, these adverse effects are
generally seen at higher exposure levels than those associated with TCE
toxicity.
    1-BP is a volatile liquid with high vapor pressure, moderate water
solubility, and high mobility in soil (Ref. 61). It is expected to
exhibit low adsorption to soil and thus can migrate rapidly through
soil to groundwater. 1-BP is slowly degraded by sunlight and reactants
when released to the atmosphere. Based on the estimated half-life of
nine to twelve days, long range transport via the atmosphere is
possible. Biotic and abiotic degradation studies have not shown this
substance to be persistent (overall environmental half-life less than
two months). While no measured bioconcentration studies for 1-BP are
available, an estimated bioaccumulation factor of 12 suggests that
bioconcentration and bioaccumulation in aquatic organisms are low.
    EPA is also concerned about the adverse health effects associated
with perchloroethylene (tetrachloroethylene) exposure. Based on the
available human epidemiologic data and experimental and mechanistic
studies, EPA has concluded that it poses a potential human health
hazard for noncancer toxicity to the central nervous system, kidney,
liver, immune and hematologic system, and on development and
reproduction. (Ref. 62) Neurotoxicity has been identified as a
sensitive endpoint following either oral or inhalation exposure. In
addition, EPA has determined that perchloroethylene
(tetrachloroethylene) is likely to be carcinogenic to humans by all
routes of exposure (Ref. 62). As with methylene chloride and 1-BP, the
adverse health effects associated with perchloroethylene
(tetrachloroethylene) are generally seen at higher exposure levels than
those associated with TCE toxicity. Perchloroethylene presents low to
moderate risk to aquatic organisms (Ref. 62). It is moderately
persistent, with a low bioaccumulation potential.
    In contrast, aqueous cleaning systems present less risk to workers.
Water-based cleaners have been used for many years in applications
where users originally used TCE or other chlorinated solvents in vapor
degreasing. In these systems, water-based cleaners are used to clean
grease or oil from parts, the parts are rinsed, sometimes with
deionized water if a spot free part is required for the next process,
and dried. The cleaner concentrate, typically made up of boric acid or
gluconic acid and other constituents, is generally diluted to between
about 5% and 20% in a heated wash bath, depending on the cleaning task
and the agitation in the equipment. The rinse is generally heated as
well. Often driers composed of air knives that drive the water from the
part are used.
    Depending on the circumstances, several different types of
equipment capable of using water-based cleaners can replace vapor
degreasing machines that use TCE. Ultrasonic cleaning systems have
transducers for generating the ultrasonic action in a bath. There are
some immersion systems where the parts are placed on a platform and
moved up and down in the cleaning

agent. In certain circumstances parts can be sprayed at pressures of
about 60 psi and greater in spray cabinets. Conveyorized spray systems,
where the parts go through high pressure spray at between about 80 and
120 psi, are also used in some cases. These systems often have wash,
rinse and dry sections.
    Water-based cleaners have a few characteristics to consider when
evaluating replacements for TCE vapor degreasing (Ref. 63). Since TCE
is used primarily to clean metal parts, the water cleaners often
contain rust or corrosion inhibitors, which typically are present at
very low concentrations, to protect the metals (Ref. 61). In addition,
in order to be used in spray equipment, water-based cleaners must be
formulated with a non-foaming surfactant. However, there are numerous
water-based cleaners available on the market that have been formulated
for these purposes (Ref. 64). In addition, the SBAR Panel convened in
support of this rulemaking heard from several SERs about the increased
water use associated with aqueous cleaning systems (more than 10,000
gallons a day). While this water can be reused in the degreasing
system, any effluent is considered industrial wastewater for which a
permit may be required under the Clean Water Act (Ref. 32).
    SERs providing input to the SBAR Panel noted that, in general the
use of TCE in vapor degreasing is declining very rapidly in certain
sectors, but is still the method of choice for some, especially for
small, intricate parts and substrates (e.g., small tubes). Several SERs
contended that none of the currently available chemical alternatives
are good substitutes for TCE because of the health hazards associated
with the substitutes, potential upcoming regulations and use
restrictions on substitutes, compliance with the NESHAP limitations,
and cost. In addition, some degreasing applications require highly
efficient cleaning, such as electronics and glass to metal seals, which
must be absolutely free of soil. A SER stated that no substitutes for
critical glass to metal seals have been identified. Several SERs stated
that substitutes with lower boiling points are not viable alternatives
because they volatilize during processes involving elevated
temperatures and because they cannot be shipped in standard drums. Most
SERs indicated that replacing their open-top vapor degreasing systems
with more sophisticated systems or alternative systems using aqueous
cleaners would be very expensive, estimates ranged from $350,000 to
$650,000. In contrast, one SER noted that water-based, or aqueous
cleaning systems can be developed to replace most TCE-based vapor
degreasing systems (Ref. 32). This same SER also stated that potential
drawbacks to aqueous cleaning systems are the increased water use and
the need for additional facility space. According to this SER, aqueous
systems are typically much larger than vapor degreasing systems and
aqueous operations often require multiple stages to reach the same
cleaning efficiency as vapor degreasers.
    Based on this input from the SERs, EPA is specifically requesting
additional comments, information, and data to assist EPA in evaluating
the availability of alternatives to TCE in vapor degreasing
applications, including information on the costs to achieve TCE
exposure reductions or to transition to alternative chemicals or
processes. In addition, EPA will consider granting a time-limited
exemption, under the authority of TSCA section 6(g), for a specific
condition of use for which EPA can obtain documentation: That the
specific condition of use is a critical or essential use for which no
technically and economically feasible safer alternative is available,
taking into consideration hazard and exposure; that compliance with the
proposed ban would significantly disrupt the national economy, national
security, or critical infrastructure; or that TCE vapor degreasing in a
specific application, as compared to reasonably available alternatives,
provides a substantial benefit to health, the environment, or public
safety. To this end, EPA requests comment on a process for receiving
and evaluating petitions and requesting EPA promulgate critical use
exemption rules. Under this process, entities who believe that their
specific condition of use is a critical or essential use under TSCA
section 6(g) would submit a petition for an exemption rulemaking with
supporting documentation that they believe demonstrates that the use
meets the statutory criteria. EPA would review the petition for
completeness and, if the documentation warrants further action, respond
to the petition by publishing a proposal in the Federal Register
inviting comment on a proposed exemption. EPA would consider the
comments received, along with any additional information reasonably
available, and then take final action on the proposed exemption. EPA
requests comment on the specific kinds of documentation that should be
required from entities seeking an exemption rulemaking in order to
facilitate EPA's and later, the public's review. EPA also requests
comment on the appropriate timeframes for EPA action, given that the
documentation for any given use could be technical and extensive, and
that EPA may also need to develop additional information, such as
economic estimates, in order to promulgate an exemption rule under TSCA
section 6(g). Finally, members of the potentially regulated community
who believe that their operation is a critical or essential use should
provide as much detail as possible to EPA about their operation during
this comment period, including information on any evaluations of
alternatives, the costs to transition to another chemical or process,
and any other relevant information. This would assist EPA in reviewing
the specific condition of use, as well as in establishing provisions
for future exemption petitions.
    EPA urges vapor degreasing facilities to think strategically about
their choices should TCE be banned for their use or if they are in the
market to replace or upgrade vapor degreasing equipment for other
reasons. To the extent that a process currently using TCE in a vapor
degreasing system can be converted to a significantly less toxic
alternative, such as an aqueous cleaning system, it will avoid
significant risks to workers and also reduce the likelihood that
further actions on toxic solvents by EPA or other regulatory
authorities will spur another process change.

E. Impacts of the Proposed and Alternative Regulatory Options

    This unit describes the estimated costs of the proposed and
alternative regulatory actions that EPA considered.
    1. Proposed approach to prohibit manufacturing (including import),
processing, distribution in commerce, and use of TCE for vapor
degreasing and require downstream notification. The costs of the
proposed approach are estimated to include equipment modification
costs, product costs, electricity, disposal, and other costs associated
with using alternative solvents or systems. Although the proposal
imposes costs resulting from downstream notification and recordkeeping
requirements, these actions required under this proposed rule are
identical in requirement and coverage to those included as part of the
earlier proposed rule on TCE use in aerosol degreasing and spot
cleaning at dry cleaning facilities (Ref. 1) that is a companion to
this proposed rule. These notification and recordkeeping costs were
accounted for as part of that proposal and are not included in the
costs for this rule. Overall, EPA estimates that 50% of users will
switch to drop-in alternatives, 25% will

convert to aqueous cleaning systems, and 25% will convert to other
alternatives. The total costs for switching from TCE-based vapor
degreasing to a substitute are estimated to be approximately $30
million to $45 million per year (annualized at 3% over 20 years) and
$32 million to $46 million (annualized at 7% over 20 years).
    2. Option that bans manufacturing (including import), processing,
distribution in commerce, and use of TCE for vapor degreasing except in
airless vacuum-to-vacuum closed-loop systems where proper PPE is used
and a requirement for downstream notification. Given equipment costs
and the burden of establishing a respiratory protection program which
involves training, respirator fit testing and the establishment of a
medical monitoring program, EPA anticipates that companies not
currently using airless vacuum-to-vacuum systems would choose to switch
to substitutes instead of purchasing an airless system and adopting a
program for PPE because substitutes are readily available and are more
technically and economic feasible. EPA also assumes that this would be
the case even if this alternative were expressed as a performance-based
air exposure limit for TCE. The estimated annualized costs of switching
to a respiratory protection program requiring PPE of APF 10,000 are
$30,000 at 3% and $32,000 at 7% per vapor degreasing machine over 20
years. In addition, there would be higher EPA administration and
enforcement costs with respiratory protection program than there would
be with an enforcement program under the proposed approach. Further,
even if cost were not an impediment, there are many limitations to the
successful implementation of respirators with an APF of 10,000 in a
workplace.
    3. Options that exclude downstream notification. For those options
that exclude downstream notification, the options are less cost
effective and more burdensome to enforce. This is even though EPA
assumes monetized enforcement costs to be the same under all options
for the purpose of this proposed rulemaking because EPA was unable to
monetize the extent to which enforcement costs would vary by regulatory
option. The proposed approach to prohibit manufacturing (including
import), processing, distribution in commerce, and use of TCE for vapor
degreasing and require downstream notification is relatively easy to
enforce because key requirements are directly placed on a small number
of suppliers and because the supply chain approach minimizes to the
greatest extent the potential for TCE products to be intentionally or
unintentionally misdirected into the prohibited uses. Enforcement under
the other options would be more difficult since the key requirements
are directly placed on the larger number of product users. Under these
other options, enforcement activities must target firms that might
perform the activity where a TCE use is restricted or prohibited.
Therefore, EPA considers downstream notification to be a critical
component of this proposal and EPA also finds that incorporating
downstream notification reduces the burden on society by easing
implementation, compliance, and enforcement.

VII. Monetized Benefits and Costs of the Proposed Rule, the
Alternatives EPA Considered, and Comparison of Benefits and Costs

    The health endpoints associated with TCE exposure are serious. The
following is a discussion of the impacts of the most significant cancer
and non-cancer effects associated with TCE exposure, including the
severity of the effect, the manifestation of the effect, and how the
effect impacts a person during their lifetime.

A. Benefits of the Proposed Rule and the Alternatives That EPA
Considered

    The risk reduction from preventing TCE exposure cannot be
comprehensively quantified or monetized even though the adverse effects
are well-documented, the TCE risk assessment estimating these risks has
been peer-reviewed, and the benefits of reducing the risk of these
health endpoints can be described. It is relatively straightforward to
monetize the benefits of reducing the risk of the costs of the effects
of cancer (kidney cancer, liver cancer, non-Hodgkin's lymphoma) due to
TCE exposure. The estimated value of the annualized benefit is
estimated to be $65 million to $447 million at 3% and $32 million to
$227 million at 7% over 20 years. It is currently not possible to
monetize the benefits of reducing the risks of the costs of non-cancer
effects (all developmental toxicity, kidney toxicity, immunotoxicity,
reproductive toxicity, neurotoxicity, and liver toxicity) of TCE
exposure. There are two reasons for this. First, dose response
information and concentration response functions in humans are not
available. This information would allow EPA to estimate the number of
population-level non-cancer cases that would be avoided by reducing
exposures to levels corresponding with MOE benchmarks. Second, even it
were possible to calculate the number of cases avoided, EPA may not be
able to monetize the benefits of these avoided cases due to limitations
in data needed to apply established economic methodologies. However,
being unable to quantitatively assess individual risk and population-
level non-cancer cases avoided from TCE exposure does not negate the
impact of these effects. Similarly, the inability to monetize an
adverse effect does not reflect the severity of the effect, the
lifetime nature of the impact, or the magnitude of the benefit in
preventing the adverse impact from TCE exposure, such as a cardiac
malformation, on a person. In considering the benefits of preventing
TCE exposure, EPA considered the type of effect, the severity of the
effect, the duration of the effect, and costs and other monetary
impacts of the health endpoint.
    The alternative options that EPA considered are unlikely to result
in the same health benefits as the proposed rule for the reasons
discussed in Unit VI. However, EPA was unable to quantify the
differences in benefits that would result from the alternatives.

B. Costs of the Proposed Rule and the Alternatives That EPA Considered

    The details of the costs of the proposed approach for use of TCE in
vapor degreasing are discussed in Unit VI.C. Under the proposed option,
costs to users of TCE in vapor degreasing applications range from $30
million to $45 million (annualized at 3% over 20 years) and $32 million
to $46 million (annualized at 7% over 20 years). Costs of downstream
notification and recordkeeping for manufacturers, processors, and
distributors on an annualized basis over 20 years are $3,200 and $4,400
using 3% and 7% discount rates respectively. However, the costs of the
downstream notification and recordkeeping requirements were already
accounted for in the prior proposal on TCE use in aerosol degreasing
and as a spotting agent in dry-cleaning facilities, and thus are not
included in the total costs for this proposal.
    The primary alternative that EPA considered is a requirement that
TCE be used for vapor degreasing only in certain closed systems and
that workers operating the systems and in the immediate area wear PPE
with an APF of 10,000. The estimated annualized costs of this option
are $32 million to $46 million annualized over 20 years at 3% and $34
million to $47 million annualized over 20 years at 7%.

C. Comparison of Benefits and Costs

    The monetized benefits for preventing the risks resulting from TCE
exposure from this use significantly outweigh the estimated costs.
Simply comparing the costs and monetized benefits of prohibiting the
manufacture (including import), processing, and distribution in
commerce of TCE for use in vapor degreasing, prohibiting commercial use
of TCE in vapor degreasing, and requiring downstream notification
demonstrates that the monetized benefits of this proposed action
outweigh the costs. However, EPA believes that the balance of costs and
benefits cannot be fairly described without considering the additional,
non-monetized benefits of mitigating the non-cancer adverse effects as
well as cancer. As discussed previously, the multitude of potential
adverse effects associated with TCE exposure can profoundly impact an
individual's quality of life. Some of the adverse effects associated
with TCE exposure can be immediately experienced and can affect a
person from childhood throughout a lifetime (e.g., cardiac
malformations, developmental neurotoxicity, and developmental
immunotoxicity). Others (e.g., adult immunotoxicity, kidney and liver
failure or cancers) can have impacts that are experienced for a shorter
portion of life, but are nevertheless significant in nature.
    While the risk of non-cancer health effects associated with TCE
exposure cannot be quantitatively estimated, the qualitative discussion
in this Unit highlights how some of these non-cancer effects occurring
much earlier in life from TCE exposure may be as severe as cancer's
mortality and morbidity and thus just as life-altering. These effects
include not only medical costs but also personal costs such as
emotional and mental stress that are impossible to accurately measure.
    While the impacts of non-cancer effects cannot be monetized, EPA
considered the impacts of these effects in deciding how best to address
the unreasonable risks presented by TCE use in vapor degreasing.
Considering only monetized benefits would significantly underestimate
the impacts of TCE-induced non-cancer adverse outcomes on a person's
quality of life to perform basic skills of daily living, including the
ability to earn a living, the ability to participate in sports and
other activities, and the impacts on a person's family and
relationships.
    Thus, considering costs, benefits that can be monetized (risk of
cancer), and benefits that cannot be quantified and subsequently
monetized (risk of developmental toxicity, kidney toxicity,
immunotoxicity, reproductive toxicity, neurotoxicity, and liver
toxicity), including benefits related to the severity of the effects
and the impacts on a person throughout her/his lifetime in terms of
medical costs, effects on earning power and personal costs, and the
emotional and psychological costs, the benefits of preventing exposures
to TCE emissions from vapor degreasing systems outweigh the costs.
Further, if EPA were to consider only the benefits that can be
monetized in comparison to the cost, the monetized benefits from
preventing kidney and liver cancer and non-Hodgkin's lymphoma from the
use of TCE in vapor degreasing (the annualized monetized benefits on a
20 year basis range from approximately $65 million to $447 million at
3% and $32 million to $227 million at 7%) far outweigh the costs of the
proposal to ban the use of TCE in vapor degreasing (the annualized
costs on a 20 year basis range from approximately $30 million to $45
million at 3% and $32 million to $46 million at 7%). Considering the
costs and benefits of the proposed and alternative options, while both
address the unreasonable risks from TCE exposure, the proposed approach
is more cost effective because it achieves the same or greater benefits
at lower costs. For more information, see Section 7 in the Economic
Analysis.

VIII. Overview of Uncertainties

    A discussion of the uncertainties associated with this proposed
rule can be found in the TCE risk assessment (Ref. 2) and in the
supplemental analysis (Ref. 30) for use of TCE in vapor degreasing. A
summary of these uncertainties follows.
    EPA used a number of assumptions in the TCE risk assessment and
supporting analysis to develop estimates for occupational exposure
scenarios and to develop the hazard/dose[hyphen]response and risk
characterization. EPA recognizes that the uncertainties may
underestimate or overestimate actual risks. These uncertainties include
the possibility that releases of and exposures to TCE vary from one
vapor degreasing machine to the next. EPA attempted to quantify this
uncertainty by evaluating multiple scenarios to establish a range of
releases and exposures. In estimating the risk from vapor degreasing,
there are uncertainties in the number of workers exposed to TCE and in
the inputs and algorithms of the models used to estimate exposures.
    In addition to the uncertainties in the risks, there are
uncertainties in the cost and benefits. The uncertainties in the
benefits are most pronounced in estimating the benefits from preventing
the non-cancer adverse effects because these benefits generally cannot
be monetized due to the lack of concentration-response functions in
humans leading to the ability to estimate the number of population-
level non-cancer cases and limitations in established economic
methodologies. Additional uncertainties in benefit calculations include
the potential risks for adverse health effects that the alternatives
may pose and the estimates of the alternatives that users might choose
to adopt. While there are some products that have comparable risks,
there are a number of alternatives that are likely to be of lower risk,
although EPA is unable to estimate the incremental change in the risk.
To account for this uncertainty, EPA includes a lower and a higher
estimate for the benefits from eliminating exposure to TCE. The lower
benefits estimate assumes no benefits for TCE users that keep the same
vapor degreasing machines and switch to methylene chloride,
perchloroethylene, 1-BP, or designer solvent alternatives, assumes that
TCE users switching to any other alternative suffer no adverse health
effects associated with the alternatives (i.e., accrue the full
benefits from eliminating TCE exposure), and applies a lowering factor
to cancer risk estimates. The higher benefits estimate includes the
benefit from entirely eliminating TCE exposure for all alternative
compliance strategies, assumes that no risks are introduced by
alternatives, and does not apply a lowering factor to cancer risk
estimates. This inability to adequately account for adverse health
effects of alternatives in the benefits analysis is expected to
contribute most to the uncertainty in the estimates.
    In addition, under certain assumptions EPA's economic analysis
estimates that some TCE users will see a cost savings when switching to
aqueous systems and certain other solvents. Standard economic theory
suggests that financially rational companies would choose technologies
that maximize profits so that regulatory outcomes would not typically
result in a cost savings for the regulated facilities. There could be
several reasons that cost savings might occur in the real world.
Potential reasons include lack of complete information or barriers to
obtaining information on the cost savings associated with alternatives
as well as investment barriers or higher interest rates faced by firms.
Additionally, there may be costs

associated with these alternatives that are not adequately accounted
for in the analysis. To evaluate the effect of this uncertainty, EPA
has included a sensitivity analysis that sets the cost savings to zero
for these compliance alternatives (Ref. 3 at section 8.2). EPA also
recognizes that these firms might experience positive costs of
compliance rather than zero costs, so that the actual total costs could
be higher than those in the sensitivity analysis. However, EPA has no
current basis to estimate these potentially higher costs, since the
available data appear to show that there are lower cost substitutes
available. EPA requests comment and/or data on any hidden costs that
may be missing from the analysis, or any other information that may
help explain why some firms appear to be missing current opportunity
for cost-savings substitutes.
    There are also uncertainties in the estimates of the number of
affected vapor degreasing machines, and for numbers of processors and
distributors of TCE-containing products not prohibited by the proposed
rule who are required to provide downstream notification and/or
maintain records. The estimate for number of facilities using TCE-
containing vapor degreasing machines is based upon available industry
information and an industry expert (Ref. 3). To estimate the number of
processors, EPA relied on public 2012 CDR data. The number of sites is
reported in the CDR data as a range. The midpoint of the reported
ranges was used to estimate the total number of sites using the
chemical. Furthermore, the CDR data only includes processors
immediately downstream of those reporting to CDR. Finally, EPA
estimated the number of wholesaler firms distributing products
containing TCE by taking a ratio of the number of Chemical and Allied
Products Merchant Wholesaler firms to Basic Chemical Manufacturing
firms and applying it to the estimated number of manufacturers and
processors of TCE (Ref. 3).
    EPA will consider additional information received during the public
comment period. This includes public comments, scientific publications,
and other input submitted to EPA during the comment period.

IX. Analysis Under TSCA Section 9 and TSCA Section 26(h) Considerations

A. TSCA Section 9(a) Analysis

    Section 9(a) of TSCA provides that, if the Administrator determines
in her discretion that an unreasonable risk may be prevented or reduced
to a sufficient extent by an action taken under a Federal law not
administered by EPA, the Administrator must submit a report to the
agency administering that other law that describes the risk and the
activities that present such risk. If the other agency responds by
declaring that the activities described do not present an unreasonable
risk or if that agency initiates action under its own law to protect
against the risk within the timeframes specified by TSCA section 9(a),
EPA is precluded from acting against the risk under sections 6(a) or 7
of TSCA.
    TSCA section 9(d) instructs the Administrator to consult and
coordinate TSCA activities with other Federal agencies for the purpose
of achieving the maximum enforcement of TSCA while imposing the least
burden of duplicative requirements. For this proposed rule, EPA has
consulted with OSHA.
    OSHA assures safe and healthful working conditions for working men
and women by setting and enforcing standards and by providing training,
outreach, education and assistance. OSHA adopted an eight-hour time
weighted average PEL of 100 ppm along with a ceiling limit in 1971
shortly after the agency was formed. It was based on the ACGIH
recommended occupational exposure limit that was in place at that time.
OSHA recognizes that the TCE PEL and many other PELs issued shortly
after adoption of the OSHA Act in 1970 are outdated and inadequate for
ensuring protection of worker health. OSHA recently published a Request
for Information on approaches to updating PELs and other strategies to
managing chemicals in the workplace (Ref. 12). OSHA's current
regulatory agenda does not include revision to the TCE PEL or other
regulations addressing the risks EPA has identified when TCE is used in
vapor degreasing or the uses identified in a prior proposal (Ref. 1),
aerosol degreasing or for spot cleaning in dry cleaning facilities
(Ref. 12).
    This proposed rule and the related proposal (Ref. 1), which EPA
intends to finalize together, address risks in both workplace (both
private- and public-sector) and consumer settings from exposure to TCE
in vapor degreasers, aerosol spray degreasers, and as a spot cleaner at
dry cleaning facilities. With the exception of TSCA, there is no
Federal law that provides authority to prevent or sufficiently reduce
these cross-cutting exposures. No other Federal regulatory authority,
when considering the exposures to the populations and within the
situations in its purview, can evaluate and address the totality of the
risk that EPA is addressing in this proposal and the prior proposal on
TCE uses (Ref. 1). For example, OSHA may set exposure limits for
workers but its authority is limited to the workplace and does not
extend to consumer uses of hazardous chemicals. Further, OSHA does not
have direct authority over state and local employees, and it has no
authority at all over the working conditions of state and local
employees in states that have no OSHA-approved State Plan under 29
U.S.C. 667. Other Federal regulatory authorities, such as CPSC, have
the authority to only regulate pieces of the risks posed by TCE, such
as when used in consumer products.
    Moreover, recent amendments to TSCA, Public Law 114-182, alter both
the manner of identifying unreasonable risk under TSCA and EPA's
authority to address unreasonable risk under TSCA, such that risk
management under TSCA is increasingly distinct from analogous
provisions of the Consumer Product Safety Act (CPSA), the Federal
Hazardous Substances Act, or the OSH Act. These changes to TSCA reduce
the likelihood that an action under the CPSA, FHSA, or the OSH Act
would reduce the risk of TCE from these uses to a sufficient extent
under TSCA. Whereas (in a TSCA section 6 rule) an unreasonable risk
determination sets the objective of the rule in a manner that excludes
cost considerations, 15 U.S.C 2605(b)(4)(A), subject to time-limited
conditional exemptions for critical chemical uses and the like, 15
U.S.C. 2605(g), a consumer product safety rule under the CPSA must
include a finding that ``the benefits expected from the rule bear a
reasonable relationship to its costs.'' 15 U.S.C. 2058(f)(3)(E).
Additionally, recent amendments to TSCA reflect Congressional intent to
``delete[] the paralyzing `least burdensome' requirement,'' 162 Cong.
Rec. S3517 (June 7, 2016). However, a consumer product safety rule
under the CPSA must impose ``the least burdensome requirement which
prevents or adequately reduces the risk of injury for which the rule is
being promulgated.''15 U.S.C. 2058(f)(3)(F). Analogous requirements,
also at variance with recent revisions to TSCA, affect the availability
of action under the FHSA relative to action under TSCA. 15 U.S.C. 1262.
Gaps also exist between OSHA's authority to set workplace standards
under the OSH Act and EPA's amended obligations to sufficiently address
chemical risks under TSCA. To set PELs for chemical exposure, OSHA must
first establish that the new standards are economically feasible and
technologically feasible. 79 FR 61387 (2014). But under TSCA, EPA's
substantive burden under TSCA Sec.  6(a) is

to demonstrate that, as regulated, the chemical substance no longer
presents an unreasonable risk, with unreasonable risk being determined
without consideration of cost or other nonrisk factors.
    TSCA is the only regulatory authority able to prevent or reduce
risks from these uses of TCE to a sufficient extent across the range of
uses and exposures of concern. In addition, these risks can be
addressed in a more coordinated, efficient and effective manner under
TSCA than under two or more different laws implemented by different
agencies. Furthermore, there are key differences between the newly
amended finding requirements of TSCA and those of the OSH Act, CPSA,
and the FHSA. For these reasons, in her discretion, the Administrator
does not determine that unreasonable risks from the use of TCE in vapor
degreasers, aerosol spray degreasers, and as a spot cleaner at dry
cleaning facilities may be prevented or reduced to a sufficient extent
by an action taken under a Federal law not administered by EPA.

B. TSCA Section 9(b) Analysis

    If EPA determines that actions under other Federal laws
administered in whole or in part by EPA could eliminate or sufficiently
reduce an unreasonable risk, section 9(b) of TSCA instructs EPA to use
these other authorities unless the Administrator determines in the
Administrator's discretion that it is in the public interest to protect
against such risk under TSCA. In making such a public interest finding,
TSCA section 9(b)(2) states: ``the Administrator shall consider, based
on information reasonably available to the Administrator, all relevant
aspects of the risk . . . and a comparison of the estimated costs and
efficiencies of the action to be taken under this title and an action
to be taken under such other law to protect against such risk.''
    Although several EPA statutes have been used to limit TCE exposure,
as discussed in Unit III.A., regulations under these EPA statutes have
limitations because they largely regulate releases to the environment,
rather than direct human exposure. SDWA only applies to drinking water.
CAA does not apply directly to worker exposures or consumer settings
where TCE is used. Under RCRA, TCE that is discarded may be considered
a hazardous waste and subject to requirements designed to reduce
exposure from the disposal of TCE to air, land and water. RCRA does not
address exposures during use of products containing TCE. Only TSCA
provides EPA the authority to regulate the manufacture (including
import), processing, and distribution in commerce, and use of chemical
substances.
    For these reasons, the Administrator does not determine that
unreasonable risks from the use of TCE in vapor degreasers, aerosol
spray degreasers, and as a spot cleaner at dry cleaning facilities
could be eliminated or reduced to a sufficient extent by actions taken
under other Federal laws administered in whole or in part by EPA.

C. Section 26(h) Considerations

    EPA has used scientific information, technical procedures,
measures, methods, protocols, methodologies, and models consistent with
the best available science. For example, EPA based its proposed
determination of unreasonable risk presented by the use of TCE in vapor
degreasing systems on the completed risk assessment, which followed a
peer review and public comment process, as well as using the best
available science and methods (Ref. 2). A supplemental analysis was
performed to better characterize the exposed populations and estimate
the effects of various control options. This supplemental analysis was
performed consistent with the methods and models used in the risk
assessment. These analyses were developed for the purpose of
determining whether the particular risks are unreasonable. They were
also developed to support risk reduction by regulation under section 6
of TSCA, to the extent risks were determined to be unreasonable. It is
reasonable and consistent to consider these analysis in this rulemaking
for such relevant purposes.
    The extent to which the various information, procedures, measures,
methods, protocols, methodologies or models, as applicable, used in
EPA's decision have been subject to independent verification or peer
review is adequate to justify their use, collectively, in the record
for this rule. Additional information on the peer review and public
comment process, such as the peer review plan, the peer review report,
and the Agency's response to comments, can be found on EPA's
Assessments for TSCA Work Plan Chemicals Web page at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/assessments-tsca-work-plan-chemicals.

X. Major Provisions and Enforcement of the Proposed Rule

    This proposal relies on general provisions in the proposed Part
751, Subpart A, which can be found at 81 FR 91592 (December 16, 2016).

A. Prohibitions on TCE Manufacturing (Including Import), Processing,
Distribution in Commerce, and Commercial Use

    This proposal would prohibit the manufacture (including import),
processing, distribution in commerce, and commercial use of TCE in
vapor degreasing.

B. Downstream Notification

    EPA has authority under TSCA section 6 to require that a substance
or mixture or any article containing such substance or mixture be
marked with or accompanied by clear and adequate warnings and
instructions with respect to its use, distribution in commerce, or
disposal or with respect to any combination of such activities. Many
TCE manufacturers and processors are likely to manufacture or process
TCE or TCE containing products for other uses that would not be
regulated under this proposal. Other companies may be strictly engaged
in distribution in commerce of TCE, without any manufacturing or
processing activities, to customers for uses that are not regulated. As
discussed in the prior proposal on TCE use in aerosol degreasers and as
a spot remover agent in dry cleaning facilities, EPA is proposing a
requirement for downstream notification by manufacturers (including
importers), processors, and distributors of TCE for any use to ensure
compliance with the proposed prohibitions on the manufacture,
processing, distribution in commerce, and commercial use of TCE.
Downstream notification is necessary for effective enforcement of the
rule because it provides a record, in writing, of notification on use
restrictions throughout the supply chain, likely via modifications to
the Safety Data Sheet. Downstream notification also increases awareness
of restrictions on use, which is likely to decrease unintentional uses
of TCE. Downstream notification represents minimal burden and is
necessary for effective enforcement of the rule. The specific
requirement, that persons who manufacture (including import), process,
or distribute in commerce TCE for any use would have to provide written
notification of the restrictions to persons to whom TCE is shipped, was
included in an earlier proposal on TCE use (Ref. 1). The specific
recordkeeping requirements were also contained in the prior proposal
(Ref. 1). Those provisions would require manufacturers (including
importers), processors, and distributors of TCE for any use to retain
documentation of the identity and

contact information for persons to whom TCE was shipped as well as the
amount of TCE shipped, and a copy of the notification that was
provided. This documentation would have to be retained for 3 years from
the date of shipment.
    As presented in the prior proposal (Ref. 1), the estimated costs of
downstream notification and recordkeeping on an annualized basis over
20 years are $3,200 and $4,400 using 3% and 7% discount rates
respectively.

C. Enforcement

    TSCA section 15 makes it unlawful to fail or refuse to comply with
any provision of a rule promulgated under TSCA section 6. Therefore,
any failure to comply with this proposed rule when it becomes effective
would be a violation of TSCA section 15. In addition, TSCA section 15
makes it unlawful for any person to: (1) Fail or refuse 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)
fail or refuse to permit entry or inspection as required by TSCA
section 11.
    Violators may be subject to both civil and criminal liability.
Under the penalty provision of TSCA section 16, any person who violates
TSCA section 15 could be subject to a civil penalty for each violation.
Each day of operation in violation of this proposed rule when it
becomes effective could constitute a separate violation. Knowing or
willful violations of this proposed rule when it becomes effective
could lead to the imposition of criminal penalties and imprisonment. In
addition, other remedies are available to EPA under TSCA sections 7 and
17.
    Individuals, as well as corporations, could be subject to
enforcement actions. TSCA sections 15 and 16 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.

D. Implementation Dates and Incentives

    As proposed in the prior action on TCE use (Ref. 1), the downstream
notification requirements and the recordkeeping requirements applicable
to manufacturers (including importers) and processors of TCE for any
use and persons who distribute TCE in commerce for any use (other than
retailers) would take effect 45 days after the final rule is issued.
EPA is proposing to make the ban on manufacturing (including
importing), processing, or distributing in commerce TCE for vapor
degreasing uses, the downstream notification requirements, and the
recordkeeping requirements effective 18 months after publication of the
final rule. The ban on the use of TCE in vapor degreasing systems would
take effect six months after that, or two years after publication of
the final rule. EPA heard from the SERs who provided input to the SBAR
Panel that converting from a vapor degreasing system that uses TCE to
one that does not is often a time-intensive process (Ref. 32). SERs had
different ideas on how long it would take for the conversion process.
One SER observed that many users do not know exactly how clean their
products must be, or how clean their existing system gets them.
According to this SER, testing is needed to determine the required
cleaning efficiency, and it can take six months for the testing.
Changing to a new system could take an additional twelve to eighteen
months. Another SER agreed with the estimate of two years for a
changeover, while still another SER thought it could take anywhere from
six months to four years. In light of this input, EPA believes that it
is reasonable to establish the compliance date for the prohibition on
TCE in vapor degreasing at two years from the date the final rule is
promulgated. EPA believes that, in most cases, the transition can be
made within this time, but EPA requests comment on whether there are
special situations which may require more time.
    EPA would like to encourage as many companies as possible to adopt
less hazardous technologies, such as aqueous cleaning systems, instead
of switching to an alternative that also presents health risks for
workers, albeit of a lower magnitude than TCE. EPA's analysis indicates
that the best answer for many vapor degreasing operations may be a
switch to water-based cleaners, even though there are higher upfront
costs. An effective system that works for a given application and that
is acceptable to customers must be researched and designed, new
equipment and cleaning solutions must be purchased, new permits may be
required, operating and safety procedures must be updated, and affected
employees must learn to operate the new equipment. However, once the
system is up and running properly, operation of the system on an annual
basis is likely to be less expensive and much less hazardous to
employees than a vapor degreasing system using TCE.
    EPA requests comment on its analysis of the alternatives and the
impacts of switching to less hazardous cleaners. EPA is particularly
interested in comments and information on water and energy use
associated with water-based cleaners and other less-toxic solvents, as
well as on the costs of conversion from a system that uses TCE and the
length of time such a conversion would take.
    EPA is also requesting comment on potential incentives for vapor
degreasing facilities to switch to less toxic alternatives. TSCA does
not provide the authority for EPA to offer incentives such as tax
credits, so there are a limited number of regulatory incentives
available to EPA. One potential incentive would be a delayed
implementation date for a ban on TCE use in vapor degreasing. This
incentive would allow vapor degreasing facilities that intend to
convert to aqueous cleaning systems a longer period of time to make the
conversion. One way to administer this incentive would be to require
vapor degreasing facilities to specifically request an extension for a
certain length of time. Of course, in order to limit misuse of this
extension opportunity, EPA would have to also require documentation of
the facility's clear intention to convert to an aqueous cleaning
system. This might include a description of the steps the company has
already taken to implement a change to aqueous substitutes, or a
description of the specific plan for implementing the change within the
extension period requested, with some sort of documentation, such as a
contract to purchase equipment. EPA also notes that TSCA section 6(d)
generally provides that compliance dates for the start of a ban or
phase-out promulgated under section 6(a) must be as soon as
practicable, but not later than five years after the rule is
promulgated, except for those critical or essential uses exempted under
TSCA section 6(g). EPA requests comments on all aspects of this
potential incentive, including comments on the length of time that
should be allowed for an extension, what documentation should be
required, and which technologies or solvents should be eligible for an
extension and how to define them. EPA also requests comments on other
potential incentives or regulatory flexibilities that EPA could
incorporate to encourage the adoption of safer degreasing technologies.
Finally, in keeping with the SBAR Panel recommendation regarding
flexibility for small businesses, EPA requests comment on whether there
are flexibilities other than delayed implementation dates that would be
particularly advantageous for small

businesses while still ensuring that they address the unreasonable
risks to which their workers may be exposed.

XI. References

    The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents referenced
within the documents that are included in the docket, even if the
referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

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treatable multisystem disease. J. Am Fam Physician. 78(8):961-8.
2008.
46. Lawrence RC, Helmick CG, Arnett FC, et al. Estimates of the
prevalence of arthritis and selected musculoskeletal disorders in
the United States. Arthritis Rheum. 1998;41(5):778-799. Cited in
Hinchcliff, M.; Varga, Systemic sclerosis/scleroderma: A treatable
multisystem disease. J. Am Fam Physician. 2008 Oct 15;78(8):961-8.
47. National Cancer Institute. SEER Stat Fact Sheets: Non-Hodgkin
Lymphoma. Bethesda, MD. http://seer.cancer.gov/statfacts/html/nhl.html. Retrieved March 16, 2016. Mayo Clinic.
48. Non-Hodgkin's lymphoma Risk Factors. January 28, 2016. http://www.mayoclinic.org/diseases-conditions/non-hodgkins-lymphoma/basics/risk-factors/con-20027792. Retrieved March 7, 2016.
49. Morton LM, Curtis RE, Linet MS, et al. Second Malignancy Risks
After Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia:
Differences by Lymphoma Subtype. Journal of Clinical Oncology.
2010;28(33):4935-4944. doi:10.1200/JCO.2010.29.1112.
50. Sharma R, Biedenharn KR, Fedor JM, Agarwal A. Lifestyle factors
and reproductive health: Taking control of your fertility.
Reproductive Biology and Endocrinology: RB&E. 2013;11:66.
doi:10.1186/1477-7827-11-66.
51. CDC. National Center for Health Statistics--Infertility.
February 6, 2015. http://www.cdc.gov/nchs/fastats/infertility.htm.
Retrieved March 16, 2016.
52. Gruenewald DA, Matsumoto AM. Testosterone supplementation
therapy for older men: Potential benefits and risks. J Am Geriatr
Soc. 2003;51(1):101-115.
53. Dadona P, Rosenberg MT. A practical guide to male hypogonadism
in the primary care setting. Int J Clin Pract. 2010;64(6):682-696.
54. International Association for the Study of Pain. http://www.iasp-pain.org/files/Content/ContentFolders/GlobalYearAgainstPain2/20132014OrofacialPain/FactSheets/Trigeminal_Neuralgia.pdf. 2013.
55. American Liver Foundation. Non-Alcoholic Fatty Liver Disease
(NAFLD). http://www.liverfoundation.org/abouttheliver/info/nafld/.
January 14, 2015. Retrieved April 4, 2016.
56. CDC. Viral Hepatitis--Statistics and Surveillance. http://www.cdc.gov/hepatitis/Statistics/index.htm. May 31, 2014. Retrieved
April 4, 2016.
57. United Network for Organ Sharing (UNOS) Transplant Living.
Financing a Transplant--Costs. December 28, 2011. Available athttp:/
/transplantliving.org/before-the-transplant/financing-a-transplant/the-costs/. Retrieved March 16, 2016.
58. EPA. Analysis Report of Alternatives in Support of Risk
Management Options for Use of TCE in Vapor Degreasing, Office of
Chemical Safety and Pollution Prevention. Washington, DC. 2016.
59. EPA. Petition to Add n-Propyl Bromide to the List of Hazardous
Air Pollutants. Receipt of a complete petition. (80 FR 6676,
February 6, 2015) (FRL-9922-13).
60. EPA. 2014. TSCA Work Plan Chemical Risk Assessment. Methylene
Chloride, Paint Stripping Use. CASRN: 75-09-2. EPA/740/R1/4002.
Office of Chemical Safety and Pollution Prevention, Washington, DC.
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-risk-assessment-methylene.
61. EPA. 2016. TSCA Work Plan Chemical Risk Assessment PEER REVIEW
DRAFT. 1-Bromopropane: (n-Propyl Bromide). Spray Adhesives, Dry
Cleaning, and Degreasing Uses. CASRN: 106-94-5. EPA/740/R1/5001.
Office of Chemical Safety and Pollution Prevention, Washington, DC.
https://www.epa.gov/sites/production/files/2016-03/documents/1-bp_report_and_appendices_final.pdf.
62. EPA. 2012. Toxicological Review of Tetrachloroethylene
(Perchloroethylene) (CAS No. 127-18-4) in Support of Summary
Information on the Integrated Risk Information System (IRIS)
(February 2012).
63. EPA. Evaluation of Water-Based Cleaners. Office of Chemical
Safety and Pollution Prevention. Washington, DC. 2016.
64. Institute for Research and Technical Assistance. Memo from Katy
Wolf to Emily Connor at ABT Associates. May 15, 2015.
65. EPA. Information Collection Request (ICR) for the Regulation of
Use in Vapor Degreasing under TSCA Sec.  6(a) (Proposed Rule). EPA
ICR No. 2541.02 and OMB No. 2070-[NEW].
66. EPA. Initial Regulatory Flexibility Analysis for
Trichloroethylene (TCE); Regulation of Use in Vapor Degreasing under
TSCA Sec.  6(a); Proposed Rule. January 2017.
67. EPA. Section 6(a) Rulemakings under the Toxic Substances Control
Act (TSCA) Paint Removers & TCE Rulemakings E.O. 13132: Federalism
Consultation. May 13, 2015.
68. EPA. Notification of Consultation and Coordination on Proposed
Rulemakings under the Toxic Substances Control Act for (1) Methylene
Chloride and n-Methylpyrrolidone in Paint Removers and (2)
Trichloroethylene in Certain Uses. April 8, 2015.

XII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is an economically significant regulatory action that
was submitted to the Office of Management and Budget (OMB) for review
under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563
(76 FR 3821, January 21, 2011). Any changes made in response to OMB
recommendations have been documented in the docket. EPA prepared an
economic analysis of the potential costs and benefits associated with
this action, which is available in the docket and summarized in Unit
VII. (Ref. 3).

B. Paperwork Reduction Act (PRA)

    The information collection requirements in this proposed rule have
been submitted to OMB for review and comment under the PRA, 44 U.S.C.
3501 et seq. The Information Collection Request (ICR) document prepared
by the Agency has been assigned EPA ICR No. 2541.02. You can find a
copy of the ICR in the docket for this proposed rule (Ref. 65), and it
is briefly summarized here.
    The information collection activities required under the proposed
rule include a downstream notification requirement and a recordkeeping
requirement. The downstream notification would require companies that
ship TCE to notify companies downstream in the supply chain of the
prohibitions of TCE in the proposed rule. The proposed rule does not
require the regulated entities to submit information to EPA. The
proposed rule also does not require confidential or sensitive
information to be submitted to EPA or downstream companies. The
recordkeeping requirement mandates companies that ship TCE to retain
certain information at the company headquarters for three years from
the date of shipment. These information

collection activities are necessary in order to enhance the
prohibitions under the proposed rule by ensuring awareness of the
prohibitions throughout the TCE supply chain, and to provide EPA with
information upon inspection of companies downstream who purchased TCE.
EPA believes that these information collection activities would not
significantly impact the regulated entities.
    Respondents/Affected Entities: TCE manufacturers, processors, and
distributors.
    Respondent's Obligation to Respond: Mandatory.
    Estimated Number of Respondents: 697.
    Frequency of Response: On occasion.
    Total Estimated Burden: 348.5 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total Estimated Cost: $16,848 (per year).
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9.
    Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden to EPA using the docket identified at
the beginning of this proposed rule. You may also send your ICR-related
comments to OMB's Office of Information and Regulatory Affairs via
email to<EMAIL_ADDRESS>Attention: Desk Officer for EPA.
Since OMB is required to make a decision concerning the ICR between 30
and 60 days after receipt, OMB must receive comments no later than
February 21, 2017. EPA will respond to any ICR-related comments in the
final rule.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 603 of the RFA, 5 U.S.C. 601 et seq., EPA
prepared an initial regulatory flexibility analysis (IRFA) that
examines the impact of the proposed rule on small entities along with
regulatory alternatives that could minimize that impact. The complete
IRFA is available for review in the docket and is summarized here (Ref.
66).
    1. Need for the rule. Under TSCA section 6(a) (15 U.S.C. 2605(a)),
if EPA determines after risk evaluation that a chemical substance
presents an unreasonable risk of injury to health or the environment,
without consideration of costs or other non-risk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant to the risk evaluation, under the conditions of
use, EPA must by rule apply one or more requirements to the extent
necessary so that the chemical substance or mixture no longer presents
such risk. Based on EPA's risk assessment of TCE (Ref. 2), EPA's
proposed determination is that the use of TCE in vapor degreasing
presents an unreasonable risk of injury to health and that the
provisions of this proposal are necessary to address the unreasonable
risk.
    2. Objectives and legal basis. The legal basis for this proposal is
TSCA section 6(a), which provides authority for the Administrator to
apply requirements to the extent necessary so that a chemical substance
or mixture no longer presents an unreasonable risk of injury to health
or the environment. Additionally, for a chemical substance, such as
TCE, which is listed in the 2014 update to the TSCA Work Plan for
Chemical Assessments for which a completed risk assessment was
published prior to the date of enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act, TSCA section 26(l)(4)
expressly authorizes EPA to issue rules under TSCA section 6(a) that
are consistent with the scope of the completed risk assessment and
consistent with the other applicable requirements of TSCA section 6.
    3. Small entities covered by this proposal. EPA estimates that the
proposal would affect approximately 2,500 to 6,000 small entities. The
majority of these entities are commercial users of TCE in vapor
degreasing machines in a variety of occupational settings such as metal
plating, electronics assembly, metal or composite part fabrication, and
repair shops.
    4. Compliance requirements and the professional skills needed. To
address the unreasonable risks that EPA has identified, this proposal
would prohibit the manufacture (including import), processing, and
distribution in commerce of TCE for use in vapor degreasing; prohibit
commercial use of TCE in vapor degreasing; and require manufacturers,
processors, and distributors, except for retailers, to provide
downstream notification of this prohibition throughout the supply chain
(e.g., via a Safety Data Sheet (SDS)), and to keep records. Complying
with the prohibitions, the downstream notification, and the
recordkeeping requirements involve no special skills. However, design
and implementation of an alternative to vapor degreasing with TCE may
involve special skills, such as engineering experience.
    5. Other Federal regulations. Other Federal regulations that affect
the use of TCE in vapor degreasing are discussed in Unit III.A. of this
preamble. Because the NESHAP regulates only emissions from vapor
degreasing facilities, not worker exposures, and because the 1971 OSHA
PEL is not sufficiently protective, EPA's proposal is not duplicative
of other Federal rules nor does it conflict with other Federal rules.
    6. Regulatory alternatives considered. EPA considered a wide
variety of control measures and the Economic Analysis (Ref. 3) examined
several alternative analytical options. However, EPA determined that
most of the alternatives did not effectively address the unreasonable
risk presented by TCE in vapor degreasing. The primary alternative
considered by EPA was to allow the use of TCE in closed-loop vapor
degreasing systems and require respiratory protection equipment for
workers operating the equipment in the form of a full face piece self-
contained breathing apparatus (SCBA) in pressure demand mode or other
positive pressure mode with an APF of 10,000 with an alternative to the
specified APF respirator of an air exposure limit. Depending on air
concentrations and proximity to the vapor degreasing equipment, other
employees in the area would also need to wear respiratory protection
equipment. While this option would address the unreasonable risks
presented by TCE in vapor degreasing, EPA's Economic Analysis indicates
that this option is more expensive and, thus less cost effective than
switching to a different solvent or cleaning system.
    As required by section 609(b) of the RFA, EPA also convened a Small
Business Advocacy Review (SBAR) Panel to obtain advice and
recommendations from small entity representatives that potentially
would be subject to the rule's requirements. The SBAR Panel evaluated
the assembled materials and small-entity comments on issues related to
elements of an IRFA. A copy of the full SBAR Panel Report is available
in the rulemaking docket. The Panel recommended that EPA seek
additional information on critical uses; availability, effectiveness,
and costs of alternatives; implementation timelines; and exposure
information to provide flexibility to lessen impacts to small entities,
as appropriate. Throughout this preamble, EPA has requested information
with respect to these and other topics. The Panel made the following
specific recommendations:

    a. Critical uses. The Panel recommended that EPA provide exemption,
in accordance with TSCA section 6(g), for those critical uses for which
EPA can obtain adequate documentation that:
     No technically and economically feasible safer alternative
is available;
     Compliance with the ban would significantly disrupt the
national economy, national security, or critical infrastructure; or
     The specific condition of use, as compared to reasonably
available alternatives, provides a substantial benefit to health, the
environment, or public safety.
    To that end, the Panel recommended that EPA include in its proposal
specific targeted requests for comment directed towards identifying
critical uses (such as the aeronautics industry and national security)
and obtaining information to justify exemptions. The Panel also
recommended that EPA request public comment on allowing the use of TCE
in closed-top vapor degreasing systems with the use of appropriate PPE.
    b. Alternatives. The Panel recommended that EPA ensure that its
analysis of the available alternatives to TCE in vapor degreasing
complies with the requirements of section 6(c)(2)(C) and includes
consideration, to the extent legally permissible and practicable, of
whether technically and economically feasible alternatives that benefit
health or the environment, compared to the use being prohibited or
restricted, will be reasonably available as a substitute when the
proposed requirements would take effect. Specifically, the Panel
recommended that EPA:
     Evaluate the feasibility of using alternatives, including
the cost, relative safety, and other barriers (such as space
constraints, cleaning efficiency, increased energy use, cycle time,
boiling points, and water use restrictions); and
     Take into consideration the current and future planned
regulation of compounds the Agency has listed as alternatives.
    c. Implementation timelines. The Panel recommended that EPA provide
regulatory flexibility, as applicable, based on additional information,
such as delayed compliance or a phase-out option, for small businesses
that may be affected by the rule and in its proposal specifically
request additional information regarding timelines for transitioning to
alternative chemicals or technologies.
    d. Cost information. The Panel also recommended that EPA
specifically evaluate the cost to small business degreasing services
without a viable alternative to TCE (i.e., the cost of going out of
business). The Panel recommended that EPA request additional
information on the cost to achieve reduced exposures in the workplace
or to transition to alternative chemicals or technologies.
    e. Exposure information. The Panel recommended that EPA include in
its proposal specific requests for additional pertinent exposure data
that may be available.
    f. Risk assessment. The Panel recommended that EPA recognize the
concerns that the SERs had on the risk assessment by referring readers
to the risk assessment and the Agency's Summary of External Peer Review
and Public Comments and Disposition document, which addresses those
concerns, in the preamble of the proposed rulemaking.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The requirements of
this action would primarily affect persons who commercially use TCE in
vapor degreasing equipment. The total estimated annualized cost of the
proposed rule is approximately $30 million to $45 million at 3% and $32
million to $46 million at 7% (Ref. 3).

E. Executive Order 13132: Federalism

    EPA has concluded that this action has federalism implications, as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999),
because regulation under TSCA section 6(a) may preempt state law. EPA
provides the following preliminary federalism summary impact statement.
The Agency consulted with state and local officials early in the
process of developing the proposed action to permit them to have
meaningful and timely input into its development. EPA invited the
following national organizations representing state and local elected
officials to a meeting on May 13, 2015, in Washington DC: National
Governors Association; National Conference of State Legislatures,
Council of State Governments, National League of Cities, U.S.
Conference of Mayors, National Association of Counties, International
City/County Management Association, National Association of Towns and
Townships, County Executives of America, and Environmental Council of
States. A summary of the meeting with these organizations, including
the views that they expressed, is available in the docket (Ref. 67).
Although EPA provided these organizations an opportunity to provide
follow-up comments in writing, no written follow-up was received by the
Agency.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This rulemaking
would not have substantial direct effects on tribal government because
TCE is not manufactured, processed, or distributed in commerce by
tribes. TCE is not regulated by tribes, and this rulemaking would not
impose substantial direct compliance costs on tribal governments. Thus,
EO 13175 does not apply to this action. EPA nevertheless consulted with
tribal officials during the development of this action, consistent with
the EPA Policy on Consultation and Coordination with Indian Tribes.
    EPA met with tribal officials in a national informational webinar
held on May 12, 2015 concerning the prospective regulation of TCE under
TSCA section 6, and in another teleconference with tribal officials on
May 27, 2015 (Ref. 68). EPA also met with the National Tribal Toxics
Council (NTTC) in Washington, DC and via teleconference on April 22,
2015 (Ref. 68). In those meetings, EPA provided background information
on the proposed rule and a summary of issues being explored by the
Agency. These officials expressed concern for TCE contamination on
tribal lands and supported additional regulation of TCE.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    This action is subject to Executive Order 13045 (62 FR 19885, April
23, 1997), because it is an economically significant regulatory action
as defined by Executive Order 12866, and EPA believes that the
environmental health or safety risk addressed by this action has a
disproportionate effect on children, specifically on the developing
fetus. Accordingly, we have evaluated the environmental health or
safety effects of TCE used in vapor degreasing on children. The results
of this evaluation are discussed in Units I.F., II.C., IV., and VI.C.
of this preamble and in the economic analysis (Ref. 3).
    Supporting information on the exposures and health effects of TCE
exposure on children is also available in the Toxicological Review of
Trichloroethylene (Ref. 4) and the TCE risk assessment (Ref. 2).

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution in Commerce, or Use

    This proposed rule is not subject to Executive Order 13211 (66 FR
28355, May 22, 2001), because this action is not expected to affect
energy supply, distribution in commerce, or use. This rulemaking is
intended to protect against risks from TCE, and does not affect the use
of oil, coal, or electricity.

I. National Technology Transfer and Advancement Act (NTTAA)

    This proposed rulemaking does not involve technical standards, and
is therefore not subject to considerations under NTTAA section 12(d),
15 U.S.C. 272 note.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse health or environmental effects of their programs, policies
and activities on minority populations and low-income populations in
the U.S. Units IV. and VI. of this preamble address public health
impacts from TCE. EPA has determined that there would not be a
disproportionately high and adverse health or environmental effects on
minority, low income, or indigenous populations from this proposed
rule.

List of Subjects in 40 CFR Part 751

    Environmental protection, Chemicals, Export certification,
Hazardous substances, Import certification, Recordkeeping.

    Dated: January 11, 2017.
Gina McCarthy,
Administrator.
    Therefore, 40 CFR part 751, as proposed to be added at 81 FR 91592
(December 16, 2016), is proposed to be further amended to read as
follows:

PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT

0
1. The authority citation for part 751 continues to read as follows:

    Authority:  15 U.S.C. 2605.

0
2. In Sec.  751.303, add the definition ``Vapor'' in alphabetical order
to read as follows:

Sec.  751.303  Definitions.

* * * * *
    Vapor degreasing means a cleaning process involving heating a
solvent to produce a hot vapor which is then used to remove
contaminants such as grease, oils, dust, and dirt from fabricated parts
and other materials.
0
3. Add Sec.  751.309 to read as follows:

Sec.  751.309  Vapor degreasing.

    (a) After [date 18 months after the date of publication of the
final rule], all persons are prohibited from manufacturing (including
import), processing, and distributing in commerce TCE and mixtures
containing TCE for use in vapor degreasing.
    (b) After [date 2 years after the date of publication of the final
rule], all persons are prohibited from commercial use of TCE and
mixtures containing TCE in vapor degreasing.

[FR Doc. 2017-01229 Filed 1-18-17; 8:45 am]
 BILLING CODE 6560-50-P