exposure range of 0.08 to 19 ppm and is within a factor of 10 of EPA's
high-end estimate of 19 ppm (Ref. 43).
    For facilities with local exhaust ventilation, EPA's inhalation
exposure level estimates were 5.0 x 10-\1\ ppm for workers
and 4.2 x 10-\1\ for bystanders. The exposure estimates for
wearing PPE combined with facilities having local exhaust ventilation
ranged from 5.0 x 10-\5\ ppm to 5.0 x 10-\2\ ppm
for workers and 4.2 x 10-\5\ ppm to 4.2 x 10-\2\
ppm for bystanders. The exposure estimates for material substitution
plus local exhaust ventilation ranged from 2.5 x 10-\2\ ppm
to 4.7 x 10-\1\ ppm for workers and 2.1 x 10-\2\
ppm to 4.0 x 10-\1\ ppm for bystanders. All exposure level
estimates for the various scenarios considered are available in the TCE
risk assessment (Ref. 1) and Supplemental Occupational Exposure and
Risk Reduction Technical Report in Support of Risk Management Options
for Trichloroethylene (TCE) Use in Spot Cleaning (Ref. 25).
    The results indicate that alternate regulatory options such as
reducing the concentration of TCE in spot cleaners for dry cleaning
facilities and using local exhaust ventilation to improve ventilation
near worker activity could not achieve the target MOE benchmarks for
non-cancer endpoints for acute and chronic exposures and standard
cancer risk benchmarks for chronic exposures. The results also
demonstrate that all risk reduction options require the use of a
respirator, whether used alone or in conjunction with additional levels
of protection, in order to meet the non-cancer and cancer risk
benchmarks (Ref. 25). Therefore, EPA found that options setting a
maximum concentration in products under section 6(a)(2) did not address
the identified unreasonable risks because the options failed--by orders
of magnitude--to meet the risk benchmarks. Options found not to meet
the risk benchmarks and which, therefore, do not address the identified
unreasonable risks are documented in EPA's supplemental technical
report on spot cleaning (Ref. 25).
    3. Assessment of regulatory options to determine whether they
address the identified unreasonable risks to the extent necessary so
that TCE no longer presents such risks. As discussed in Unit V., EPA
considered a number of regulatory options under section 6(a) to address
TCE risks from spot cleaning in dry cleaning facilities which are
reflected in EPA's supporting analysis (Ref. 29). In assessing these
options, EPA considered a wide range of exposure scenarios (Ref. 25).
These include both baseline and risk reduction scenarios involving
varying factors such as reduction of TCE content in spot cleaners,
exposure concentration percentiles, local exhaust ventilation use,
respirator use, working lifetimes, etc. The options that could reduce
the risks of TCE use to the benchmark MOE and standard cancer
benchmarks for spot cleaning in dry cleaning include (a) prohibiting
the manufacture, processing, and distribution in commerce of TCE for
use as a spot cleaner in dry cleaning facilities (section 6(a)(2)) plus
prohibiting the use of TCE as a spot cleaner in dry cleaning facilities
(section 6(a)(5)) and requiring downstream notification when
distributing TCE for other uses under section 6(a)(3); (b) variations
on such a supply-chain approach (such as just prohibiting the
manufacture, processing, distribution in commerce of TCE for use as a
spot cleaner in dry cleaning facilities under section 6(a)(2) or just
prohibiting the commercial use of TCE as a spot cleaner in dry cleaning
facilities under section 6(a)(5)); (c) requiring the use of personal
protective equipment in dry cleaning facilities in which TCE is used as
a spot cleaner under section 6(a)(5) or requiring the use of personal
protective equipment and engineering controls in dry cleaning
facilities in which TCE is used as a spotting agent under section
6(a)(5).
    The full range of regulatory options considered under section 6(a)
is reflected in EPA's supporting analysis (Ref. 29). A discussion of
the regulatory options that were determined to have the potential to
address the identified unreasonable risks is provided in this Unit,
along with the Agency's evaluation of how well those regulatory options
would address the unreasonable risks in practice.
    a. Proposed approach to prohibit manufacturing, processing,
distribution in commerce, and use of TCE for spot cleaning in dry
cleaning facilities and require downstream notification. As noted
previously, the proposed regulatory approach uses several elements of
TSCA section 6(a) to address the risk of TCE use for spot cleaning in
dry cleaning facilities throughout the supply chain. The proposed
regulatory approach would prohibit the manufacturing, processing, and
distribution in commerce of TCE for spot cleaning in dry cleaning
facilities under TSCA Sec.  6(a)(2), prohibit the commercial use of TCE
for spot cleaning in dry cleaning facilities under TSCA Sec.  6(a)(5),
and require manufacturers, processors, and distributors, except for
retailers, to provide downstream notification, e.g., via a SDS, of the
prohibitions under TSCA Sec.  6(a)(3).
    As discussed in Unit VII.B.1, the MOEs for occupational exposure
for spot cleaning in dry cleaning facilities are below the non-cancer
MOE benchmarks for all non-cancer effects (e.g., developmental effects,
kidney toxicity, and immunotoxicity) and standard cancer benchmarks.
Under this proposed approach, exposures to TCE from this use would be
completely eliminated. As a result, both non-cancer and cancer risks
from exposure to TCE from this use would be eliminated (Ref. 39). All
employees in dry cleaning facilities would benefit; and Asian and
Hispanic populations, which are over-represented in dry cleaning
facilities, would disproportionally benefit from the proposed approach.
    The proposed approach would ensure that workers and occupational
bystanders are no longer at risk from TCE exposure associated with this
use throughout the supply chain. By proposing to prohibit the
manufacture, processing and distribution in commerce of TCE for use as
a spot cleaner in dry cleaning facilities, EPA would ensure that
manufacturers, processors and distributors would not sell TCE for a use
that EPA has determined presents an unreasonable risk of injury to
health, and the intentional or unintentional availability of TCE for
spot cleaning in dry cleaning facilities would be minimized. The
proposal to prohibit commercial use of TCE as a spot cleaner in dry
cleaning facilities would eliminate commercial demand for TCE-based
spot cleaning products and would more effectively protect workers and
bystanders than a prohibition only on manufacture, processing or
distribution for this use under Section 6(a)(2). The prohibition on
commercial use ensures that commercial users would not be able to
divert TCE manufactured for other

allowable uses to this prohibited use without consequence. The
downstream notification of these restrictions ensures that processors,
distributors, and purchasers are aware of the manufacturing,
processing, and distribution in commerce and use restrictions for TCE
spot cleaner uses in dry cleaning facilities and helps to ensure that
the rule is effectively implemented by avoiding off-label use as a spot
cleaner of TCE manufactured for other uses. Downstream notification
also streamlines and aids in compliance and enhances enforcement.
Overall, downstream notification facilitates implementation of the
rule. Collectively the proposed approach completely mitigates the risk
from TCE in spot cleaners in dry cleaning facilities. In addition, the
proposed approach would provide staggered compliance dates for
implementing the prohibition of manufacturing, processing, distribution
in commerce, and commercial use in order to avoid undue impacts on the
businesses involved.
    b. Options that are variations of the proposed approach to prohibit
manufacturing, processing, distribution in commerce, and use of TCE for
spot cleaning in dry cleaning facilities and require downstream
notification. Another regulatory option that EPA considered was to
prohibit only the commercial use of TCE for spot cleaning in dry
cleaning facilities under TSCA Sec.  6(a)(5). This option could reach
the risk benchmarks for TCE (Ref. 29). While this approach could
eliminate non-cancer and cancer risks, in practice it would not address
the identified unreasonable risks because users would easily be able to
obtain TCE for use in dry cleaning facilities or would likely
unknowingly purchase spot agents which contain TCE. If the Agency were
to prohibit use alone, without the prohibition on manufacture,
processing, and distribution in commerce for the use of TCE for spot
cleaning in dry cleaning facilities, there is a greater likelihood that
TCE manufactured for non-prohibited uses could be diverted to
prohibited uses. Users would likely unknowingly purchase materials that
they do not realize contain TCE because they would not be aware of the
prohibition, which would result in unreasonable risks for those users.
Taking the supply chain approach to addressing the risk of TCE in spot
cleaning at commercial dry cleaning facilities helps to ensure that TCE
manufactured for other allowed uses would not be used for this
prohibited use.
    Due to the large number of dry cleaning facilities in the United
States (approximately 61,000), EPA is concerned that without the
section 6(a)(3) downstream notification requirement, these entities
might not become aware of the prohibition on TCE in spot cleaning
because they may be unaware that certain products actually contain TCE.
Thus, without downstream notification, EPA anticipates that the risk
benchmarks would not actually be realized by many users. Therefore,
such an option fails to address the identified unreasonable risks,
considering the practical limitations.
    Another regulatory option that EPA considered was to prohibit only
the manufacturing, processing or distribution in commerce of TCE for
spot cleaning in dry cleaning facilities under TSCA section 6(a)(2) or,
a variation of this option: A prohibition of manufacturing, processing,
or distribution in commerce of TCE for spot cleaning in dry cleaning
facilities and require downstream notification when distributing TCE
for other uses under section 6(a)(3). This option could reach the risk
benchmarks for TCE (Ref. 29). However, this option introduces
weaknesses, such as likelihood for users to obtain TCE for spot
cleaning through other means, and thereby fails to address the
identified unreasonable risks. For example, if only manufacturing,
processing and distribution in commerce for the spot cleaning use in
dry cleaners were prohibited without also prohibiting the use, dry
cleaning facilities could go to other sources to acquire TCE for non-
prohibited uses and divert those uses to the spot cleaning use without
consequence. This would be the case even if the prohibition on
manufacturing, processing and distribution in commerce were accompanied
by the downstream notification requirement. A combined approach would
ensure that the section 6(a) requirements address the identified
unreasonable risks.
    c. Require the use of personal protective equipment in commercial
dry cleaning facilities in which TCE is used as a spot cleaner under
section 6(a)(5) or require the use of personal protective equipment and
engineering controls in commercial dry cleaning facilities in which TCE
is used as a spot cleaner under section 6(a)(5). Another regulatory
option that EPA considered was to require the use of respirators in the
form of a supplied-air respirator with an APF of 10,000 for workers at
risk of exposure to TCE with a performance based option using an air
exposure limit. See Unit VI.B.3.d for a discussion of issues and
drawbacks of requiring the use of a supplied-air respirator. In
addition, while this option could mitigate the risk for workers, dry
cleaning facilities are generally small shops and many are co-located
in commercial shopping centers where the work goes on in plain view of
customers or are co-located with residential buildings. It is highly
unlikely that dry cleaning operations would undertake fitting all of
their workers with the full face piece SCBA apparatus with accompanying
supplied air breathing device necessary to mitigate risk. This approach
could have separate economic impacts because consumers may not wish to
enter an establishment in which workers are wearing supplied-air
respirators. In addition, many dry cleaning establishments are located
near residential areas. Local residents may react adversely to an
establishment using chemicals which require a supplied-air respirator.
    EPA also considered requiring the combination of the use of local
exhaust ventilation which achieves 90% reduction in airborne
concentrations to improve ventilation near the worker activity and a
supplied-air respirator with an APF of 1,000 with a performance based
option using an air exposure limit. EPA conducted a risk analysis for
both baseline exposures and exposures after implementing risk
management options, allowing for a direct comparison of the acute and
chronic risks associated with the exposures following application of a
risk reduction option. This option would also reduce risks to the
health benchmarks for workers when used properly (Ref. 25). While this
option has the benefit of incorporating engineering controls and use of
a respirator with a lower APF, there are still the limitations to
successful implementation of the use of supplied-air respirators in the
workplace as discussed previously.

C. Availability of Substitutes and Impacts of the Proposed and
Alternative Regulatory Options

    This Unit examines the availability of substitutes for TCE as a
spot cleaner in dry cleaning facilities and describes the estimated
costs of the proposal and the alternatives that EPA considered. More
information on the benefits and costs of this proposal as a whole can
be found in Unit VIII.
    Overall, EPA notes that the costs of dry cleaning spot cleaning
product reformulation are low. Total first-year reformulation costs are
estimated to be $286,000 and annualized costs are approximately $22,000
per year (annualized at 3% over 15 years) and $28,000 (annualized at 7%
over 15 years). A wide variety of effective

substitutes for TCE in spot cleaning applications indicates that
producers and users can readily shift from TCE to less hazardous
chemical substitutes. Limitations on these or similar uses of TCE are
already in place in many states in the United States and
internationally. For example, TCE use is prohibited in California for
aerosol and non-aerosol consumer spot removers. TCE is also prohibited
in the European Union for spot cleaning use in dry cleaning facilities.
In addition, according to the Drycleaning and Laundry Institute, a
trade association representing more than 4,000 dry cleaning operations
in the United States, not all dry cleaning facilities use TCE, and many
other alternatives are available and equally effective (Refs. 42, 43).
Further, prohibitions in California and the European Union indicate
that the transition can be made to substitutes, demonstrating that
switching to alternatives would not be overly difficult for users.
Producers of spot cleaning products containing TCE also produce spot
cleaning products with substitute chemicals. Thus, there is already
precedent for producers reformulating products to meet demand in some
states and countries. In addition, EPA expects that one effect of a ban
on the use of TCE for spot cleaning at dry cleaning facilities would be
increased technological innovation, resulting in the development of
additional alternatives.
    1. Proposed approach to prohibit manufacturing, processing,
distribution in commerce, and use of TCE for spot cleaning in dry
cleaning facilities and require downstream notification. The costs of
the proposed approach are estimated to include product reformulation
costs, downstream notification and recordkeeping costs, and Agency
costs. The total first-year costs of dry cleaning spot cleaning product
reformulation are approximately $286,000 and annualized are estimated
to be $22,000 per year (at 3% over 15 years) and $28,000 (at 7% over 15
years). The costs to users of dry cleaning spot cleaning products are
negligible as substitute products are currently available on the market
and are similarly priced. The costs of downstream notification and
recordkeeping are estimated to be $51,000 and on an annualized basis
over 15 years are $3,900 and $5,000 using 3% and 7% discount rates
respectively. Agency costs for enforcement are estimated to be
approximately $112,000 and $109,000 annualized over 15 years at 3% and
7%, respectively. Annual recurring costs to the Agency for enforcement
are estimated to be $121,000 per year. The total cost of the proposed
approach for the dry cleaning spot cleaning use is estimated to be
$130,000 to $133,000 and $135,000 to $137,000 annualized at 3% and 7%,
respectively, over 15 years.
    2. Options that require personal protective equipment. The costs of
implementing a respiratory protection program, including a supplied-air
respirator and related equipment, training, fit testing, monitoring,
medical surveillance, and related requirements, would far exceed the
costs of switching to alternatives, on a per facility basis. The
estimated annualized costs of switching to a respiratory protection
program requiring PPE of 10,000 are $8,200 at 3% and $9,000 at 7% per
dry cleaning facility over 15 years. The estimated annualized costs of
switching to a respiratory protection program requiring PPE of 1,000
are $5,800 at 3% and $5,800 at 7% per dry cleaning facility over 15
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.
    3. Options that exclude downstream notification. EPA was unable to
monetize the extent to which enforcement costs would vary by regulatory
option so EPA assumed monetized enforcement costs to be the same under
all options for the purpose of this proposed rulemaking. The proposed
approach to prohibit manufacturing, processing, distribution in
commerce, and use of TCE for spot cleaning in dry cleaning facilities
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 much more difficult since the key
requirements are directly placed on the large 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. For the prohibition on TCE in dry cleaning spot removers,
this would include all dry cleaning establishments. (Ref. 2).
Therefore, while EPA considers downstream notification to be a critical
component of this proposal, EPA also finds that incorporating
downstream notification reduces the burden on society by easing
implementation, compliance, and enforcement.

D. Summary

    The proposed approach to prohibit manufacturing, processing,
distribution in commerce, and use of TCE for spot cleaning in dry
cleaning facilities and require downstream notification is necessary to
ensure that TCE no longer presents unreasonable risks for this use.
This option does not pose an undue burden on industry because
comparable substitutes to TCE for spot cleaning in dry cleaning
facilities are readily available. This approach also protects workers
and occupational bystanders from the identified unreasonable risks by
providing downstream notification of the prohibition throughout the
supply chain and avoiding off-label purchase and use of TCE for the
prohibited use. Downstream notification streamlines compliance and aids
in compliance and enhances enforcement.

VIII. Other Factors Considered

    When issuing a rule under TSCA section 6(a), EPA must consider and
publish a statement based on reasonably available information on the:
     Health effects of the chemical substance in question, TCE
in this case, and the magnitude of human exposure to TCE;
     Environmental effects of TCE and the magnitude of exposure
of the environment to TCE;
     Benefits of TCE for various uses; and the
     Reasonably ascertainable economic consequences of the
rule, including the likely effect of the rule on the national economy,
small business, technological innovation, the environment, and public
health, the costs, benefits, and cost-effectiveness of the rule and of
the one or more primary alternatives that EPA considered.
    TSCA section 6(c)(2)(B) instructs EPA, when selecting among
prohibitions and other restrictions under 6(a) to factor in, to the
extent practicable, these considerations. This Unit provides more
information on the benefits, costs, and cost-effectiveness of this
proposal and the alternatives that EPA considered.
    As discussed in Unit IV.B, TCE exposure is associated with a wide
array of adverse health effects. These health effects include
developmental toxicity (e.g., cardiac malformations, developmental
immunotoxicity, developmental neurotoxicity, fetal death), toxicity to
the kidney (kidney damage and kidney cancer), immunotoxicity (such as
systemic autoimmune diseases e.g., scleroderma) and severe
hypersensitivity skin

disorder, non-Hodgkin's lymphoma, endocrine and reproductive effects
(e.g., decreased libido and potency), neurotoxicity (e.g., trigeminal
neuralgia), and toxicity to the liver (impaired functioning and liver
cancer) (Ref. 1). TCE may cause fetal cardiac malformations that begin
in utero. In addition, fetal death, possibly resulting from cardiac
malformation, can be caused by exposure to TCE. Cardiac malformations
can be irreversible and impact a person's health for a lifetime. Other
effects, such as damage to the developing immune system, may first
manifest when a person is an adult and can have long-lasting health
impacts. Certain effects that follow adult exposures, such as kidney
and liver cancer, may develop many years after initial exposure. The
point during a lifetime when the effect manifests itself and the
expected impacts to a person during her/his lifetime are important
factors in determining the benefits of mitigating and preventing TCE
exposure.
    Based on EPA's analysis of worker and consumer populations'
exposure to TCE, EPA has determined that there are significant cancer
and non-cancer risks (acute and chronic) from TCE exposure, which can
result in developmental effects, kidney toxicity, immunotoxicity,
reproductive toxicity, neurotoxicity, and liver toxicity. These risks
are unreasonable risks because the chemical exposures predicted for the
various scenarios assessed are above what would be necessary to achieve
the MOE benchmarks for cardiac defects, kidney toxicity,
immunotoxicity, liver toxicity, neurotoxicity and endocrine and
reproductive toxicity. For commercial use scenarios of aerosol
degreasing and use of TCE for spot cleaning in dry cleaning facilities,
as well as for all the residential use scenarios, exposures are far
beyond what would be necessary to achieve the MOE benchmark for cardiac
defects. For example, the 99th percentile of the upper end exposure use
scenario for aerosol degreasing has a MOE of 0.003 for chronic
exposures and 0.002 for acute exposures. Thus, for this aerosol
degreasing use scenario, people are exposed at a level that is 3,000
times higher than what EPA determines is protective for the non-cancer
health effect.
    The number of people at risk for the developmental effects is
estimated to be up to approximately 5,400 pregnant women in dry
cleaning operations and approximately 900 pregnant women exposed to TCE
during the use of aerosol degreasers. The potential for exposure is
significant because approximately half of all pregnancies are
unintended. If a pregnancy is not planned before conception, a woman
may not be in optimal health for childbearing (Ref. 33).
    Given the large differential between the benchmark MOE and the MOEs
resulting from EPA's estimates of exposures, people exposed to TCE in
aerosol degreasing and during dry cleaning operations are at
significant risk for the multiple adverse non-cancer health effects
caused by TCE and the impacts discussed below on many facets of their
life that these adverse health effects cause. These risks are
significant even when considered alone. However, workers may be also be
impacted by the significant risks for several types of cancer. The
cancer risks to workers using TCE in aerosol degreasing and for spot
cleaning in dry cleaning facilities are 1.6 x 10-2 or more
than one and one-half cases in one hundred for aerosol degreasing and
1.4 x 10-2 or more than one case in one hundred for use of
TCE for spot cleaning in dry cleaning facilities.
    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 cancer (kidney cancer,
liver cancer, non-Hodgkin's lymphoma) due to TCE exposure. The
estimated value of the annualized benefit is estimated to be $9.3
million to $25.0 million at 3% and $4.5 million to $12.8 million at 7%
over 15 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, which
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 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. While TCE can cause a
variety of adverse health effects, the general population incidences of
these adverse health outcomes are not due solely to TCE.

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

    1. Developmental effects. The TCE risk assessment (and EPA's 2011
IRIS Assessment) identified developmental effects as the critical
effect of greatest concern for both acute and chronic non-cancer risks.
There are increased health risks for developmental effects to the
approximately 900 pregnant women exposed to TCE during the use of
aerosol degreasers and approximately 5,400 pregnant women working in
dry cleaning operations (Ref. 2). Specifically, these assessments
identified fetal cardiac malformations in the offspring of mothers
exposed to TCE during gestation as the critical effect. Although fetal
cardiac defects is the most sensitive endpoint and is the focus of the
discussion in this Unit, TCE exposures can result in other adverse
developmental outcomes, including prenatal (e.g., spontaneous abortion
and perinatal death, decreased birth weight, and congenital
malformations) and postnatal (e.g., growth, survival, developmental
neurotoxicity, developmental immunotoxicity, and childhood cancers)
effects. Developmental TCE exposure results in qualitatively different
immunotoxicity effects than adult exposure. These effects influence the
development of the immune system and result in impairment of the immune
system to respond to infection whereas adult exposures result in more
pronounced immune response related to autoimmune responses.
    Cardiac defects, which can result from very low level exposure to
TCE, affect

the structural development of a baby's heart and how it works. The
defects impact how blood flows through the heart and out to the rest of
the body. The impact can be mild (such as a small hole in the heart) or
severe (such as missing or poorly formed septal wall and valves of the
heart). While diagnosis for some cardiac defects can occur during
pregnancy, for other cardiac defects, detection may not occur until
after birth or later in life, during childhood or adulthood. These
cardiac defects can be occult or life- threatening with the most severe
cases causing early mortality and morbidity. While the incidences in
the following paragraphs 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.
    Nearly 1% or about 40,000 births per year in the United States are
affected by cardiac defects (Ref. 46). About 25% of those infants with
a cardiac defect have a critical defect. Infants with critical cardiac
defects generally need surgery or other procedures in their first year
of life. Some estimates put the total number of individuals (infants,
children, adolescents, and adults) living with cardiac defects at 2
million (Ref. 46). Cardiac defects can be caused by genetics,
environmental exposure, or an unknown cause.
    Infant deaths resulting from cardiac defects often occur during the
neonatal period. One study indicated that cardiac defects accounted for
4.2% of all neonatal deaths. Of infants born with a non-critical
cardiac defect, 97% are expected to survive to the age of one, with 95%
expected to survive to 18 years of age. Of infants born with a critical
cardiac defect, 75% are expected to survive to one year of age, with
69% expected to survive to 18 years of age (Ref. 47). A child with a
cardiac defect is 50% more likely to receive special education services
compared to a child without birth defects (Ref. 46).
    Treatments for cardiac defects vary. Some affected infants and
children might need one or more surgeries to repair the heart or blood
vessels. In other instances, a heart defect cannot be fully repaired,
although treatments have advanced such that infants are living longer
and healthier lives. Many children are living into adulthood and lead
independent lives with little or no difficulty. Others, however, may
develop disability over time which is hard to predict and for which it
is difficult to quantify impacts.
    Even though a person's heart defect may be repaired, for many
people this is not a cure. They can still develop other health problems
over time, depending on their specific heart defect, the number of
heart defects they have, and the severity of their heart defect. For
example, some related health problems that might develop include
irregular heart beat (arrhythmias), increased risk of infection in the
heart muscle (infective endocarditis), or weakness in the heart
(cardiomyopathy). In order to stay healthy, a person needs regular
checkups with a cardiologist. They also might need further operations
after initial childhood surgeries (Ref. 46).
    Depending upon the severity of the defect, the costs for surgeries,
hospital stays, and doctor's appointments to address a baby's cardiac
defect can be significant. The costs for the defects may also continue
throughout a person's lifetime. In 2004, hospital costs in the United
States for individuals with a cardiac defect were approximately $1.4
billion (Ref. 46).
    Beyond the monetary cost, the emotional and mental toll on parents
who discover that their child has a heart defect while in utero or
after birth will be high (Ref. 47). They may experience anxiety and
worry over whether their child will have a normal life of playing with
friends and participating in sports and other physical activities, or
whether their child may be more susceptible to illness and be limited
in the type of work and experiences they can have. In addition, parents
can be expected to experience concerns over potential unknown medical
costs that may be looming in the future, lifestyle changes, and being
unable to return to work in order to care for their child.
    The emotional and mental toll on a person throughout childhood and
into adolescence with a heart defect also should be considered (Ref.
47). Cardiac patients who are children may feel excluded from
activities and feel limited in making friends if they have to miss
school due to additional surgeries, or may not be able to fully
participate in sports or other physical exercise. Children may feel
self-conscious of the scars left by multiple surgeries. This, in turn,
adds emotional and mental stress to the parents as they observe their
child's struggles.
    As a person with a heart defect enters adulthood, the emotional or
mental toll of a cardiac defect may continue or in other instances the
problem may only surface as the person becomes an adult. If a cardiac
defect impacts a person's ability to enter certain careers, this could
take a monetary as well as emotional toll on that person and on their
parents or families who may need to provide some form of financial
support. The monetary, emotional, and mental costs of heart defects can
be considerable, and even though neither the precise reduction in
individual risk of developing a cardiac defect from reducing TCE
exposure or the total number of cases avoided can be estimated, their
impact should be considered.
    2. Kidney toxicity. The TCE risk assessment identified kidney
toxicity as a significant concern for non-cancer risk from TCE exposure
with the risk being from chronic exposure. There are increased health
risks for kidney toxicity to the approximately 10,800 workers and
occupational bystanders at commercial aerosol degreasing operations and
the up to approximately 168,000 workers and occupational bystanders in
dry cleaning operations (Ref. 2).
    Exposure to TCE can lead to changes in the proximate tubules of the
kidney. This damage may result in signs and symptoms of acute kidney
failure that include: Decreased urine output, although occasionally
urine output remains normal; fluid retention, causing swelling in the
legs, ankles or feet; drowsiness, shortness of breath, fatigue,
confusion, nausea, seizures or coma in severe cases; and chest pain or
pressure. Sometimes acute kidney failure causes no signs or symptoms
and is detected through lab tests done for another reason.
    Kidney toxicity means the kidney(s) has suffered damage that can
result in a person being unable to rid their body of excess urine and
wastes. In extreme cases where the kidney(s) is impaired over a long
period of time, the kidney(s) could be damaged to the point that it no
longer functions. When a kidney(s) no longer functions, a person needs
dialysis and ideally a kidney transplant. In some cases, a non-
functioning kidney(s) can result in death. Kidney dialysis and kidney
transplantation are expensive and incur long-term health costs if
kidney function fails (Ref. 48).
    Approximately 31 million people, or 10% of the adult population, in
the United States have chronic kidney disease. In the United States, it
is the ninth leading cause of death. About 93% of chronic kidney
disease is from known causes, including 44% from diabetes and 28.4%
from high blood pressure. Unknown or missing causes account for about
6.5% of cases, or about 2 million people (Ref. 49).
    The monetary cost of kidney toxicity varies depending on the
severity of the damage to the kidney. In less severe cases, doctor
visits may be limited and hospital stays unnecessary. In more

severe cases, a person may need serious medical interventions, such as
dialysis or a kidney transplant if a donor is available, which can
result in high medical expenses due to numerous hospital and doctor
visits for regular dialysis and surgery if a transplant occurs. The
costs for hemodialysis, as charged by hospitals, can be upwards of
$100,000 per month (Ref. 50).
    Depending on the severity of the kidney damage, kidney disease can
impact a person's ability to work and live a normal life, which in turn
takes a mental and emotional toll on the patient. In less severe cases,
the impact on a person's quality of life may be limited while in
instances where kidney damage is severe, a person's quality of life and
ability to work would be affected. While neither the precise reduction
in individual risk of developing kidney toxicity from reducing TCE
exposure or the total number of cases avoided can be estimated, these
costs must still be considered because they can significantly impact
those exposed to TCE.
    Chronic exposure to TCE can also lead to kidney cancer. The
estimated value of the annualized benefit is $276,000 to $661,000 for
aerosol degreasing and $1.4 million to $5.5 million for spot cleaning
in dry cleaning facilities at 3% over 15 years; and $135,000 to
$349,000 for aerosol degreasing and $677,000 to $2.9 million for spot
cleaning in dry cleaning facilities at 7% over 15 years. Kidney cancer
rarely shows signs or symptoms in its early stages. As kidney cancer
progresses, the cancer may grow beyond the kidney spreading to lymph
nodes or distant sites like the liver, lung or bladder increasing the
impacts on a person and the costs to treat it. This metastasis is
highly correlated with fatal outcomes. Impacts of kidney cancer that
are not monetized include the emotional, psychological impacts and the
impacts of treatment for the cancer on the well-being of the person.
    3. Immunotoxicity. a. Non-cancer chronic effects. The TCE risk
assessment identified immunotoxicity as a chronic non-cancer risk from
TCE exposure. There are increased health risks for immunotoxicity to
the approximately 10,800 workers and occupational bystanders at
commercial aerosol degreasing operations and the up to approximately
168,000 workers and occupational bystanders in dry cleaning operations
(Ref. 1).
    Human studies have demonstrated that TCE exposed workers can suffer
from systemic autoimmune diseases (e.g., scleroderma) and severe
hypersensitivity skin disorder. Scleroderma is a chronic connective
tissue disease with autoimmune origins. The annual incidence is
estimated to be 10 to 20 cases per 1 million persons (Ref. 51), and the
prevalence is four to 253 cases per 1 million persons (Ref. 52). About
300,000 Americans are estimated to have scleroderma. About one third of
those people have the systemic form of scleroderma. Since scleroderma
presents with symptoms similar to other autoimmune diseases, diagnosis
is difficult. There may be many misdiagnosed or undiagnosed cases (Ref.
52).
    Localized scleroderma is more common in children, whereas systemic
scleroderma is more common in adults. Overall, female patients
outnumber male patients about 4-to-1. Factors other than a person's
gender, such as race and ethnic background, may influence the risk of
getting scleroderma, the age of onset, and the pattern or severity of
internal organ involvement. The reasons for this susceptibility are not
clear. Although scleroderma is not directly inherited, some scientists
believe there is a slight predisposition to it in families with a
history of rheumatic diseases (Ref. 53).
    The symptoms of scleroderma vary greatly from person-to-person with
the effects ranging from very mild to life threatening. If not properly
treated, a mild case can become much more serious. Relatively mild
symptoms are localized scleroderma, which results in hardened waxy
patches on the skin of varying sizes, shapes and color. The more life
threatening symptoms are from systemic scleroderma, which can involve
the skin, esophagus, gastrointestinal tract (stomach and bowels),
lungs, kidneys, heart and other internal organs. It can also affect
blood vessels, muscles and joints. The tissues of involved organs
become hard and fibrous, causing them to function less efficiently.
    Severe hypersensitivity skin disorder includes exfoliative
dermatitis, mucous membrane erosions, eosinophilia, and hepatitis.
Exfoliative dermatitis is a scaly dermatitis involving most, if not
all, of the skin. Eosinophilia on the other hand is a chronic disorder
resulting from excessive production of a particular type of white blood
cells. If diagnosed and treated early a person can lead a relatively
normal life (Ref. 51).
    The monetary costs for treating these various immunotoxicity
disorders will vary depending upon whether the symptoms lead to early
diagnosis and early diagnosis can influence whether symptoms progress
to mild or life threatening outcomes. For mild symptoms, doctors'
visits and outpatient treatment could be appropriate while more severe
immunotoxicity disorders, may require hospital visits. Treatments for
these conditions with immune modulating drugs also have countervailing
risks.
    These disorders also take an emotional and mental toll on the
person as well as on their families. Their quality of life may be
impacted because they no longer have the ability to do certain
activities that may affect or highlight their skin disorder, such as
swimming. Concerns over doctor and hospital bills, particularly if a
person's ability to work is impacted, may further contribute to a
person's emotional and mental stress. While neither the precise
reduction in individual risk of developing this disorder from TCE
exposure or the total number of cases avoided can be estimated, this
should be considered.
    b. Non-Hodgkin's Lymphoma. EPA's 2011 IRIS assessment for TCE found
that TCE is carcinogenic. Chronic exposure to TCE, by all routes of
exposure, can result in non-Hodgkin's lymphoma (NHL), one of the three
cancers for which the EPA TCE IRIS assessment based its cancer
findings. There are increased health risks for NHL for the
approximately 10,800 workers and occupational bystanders at commercial
aerosol degreasing operations and the up to approximately 168,000
workers and occupational bystanders in dry cleaning operations (Ref.
2).
    NHL is a form of cancer that originates in a person's lymphatic
system. For NHL, there are approximately 19.7 new cases per 100,000 men
and women per year with 6.2 deaths per 100,000 men and women per year.
NHL is the seventh most common form of cancer (Ref. 53). Some studies
suggest that exposure to chemicals may be linked to an increased risk
of NHL. Other factors that may increase the risk of NHL are medications
that suppress a person's immune system, infection with certain viruses
and bacteria, or older age (Ref. 54).
    Symptoms are painless, swollen lymph nodes in the neck, armpits or
groin, abdominal pain or swelling, chest pain, coughing or trouble
breathing, fatigue, fever, night sweats, and weight loss. Depending on
the rate at which the NHL is advancing, the approach may be to monitor
the condition, while more aggressive NHL could require chemotherapy,
radiation, stem cell transplant, medications that enhance a person's
immune system's ability to fight cancer, or medications that deliver
radiation directly to cancer cells.

    Treatment for NHL will result in substantial costs for hospital and
doctors' visits in order to treat the cancer. The treatments for NHL
can also have countervailing risks and can lead to higher
susceptibility of patients for secondary malignancies (Ref. 55). The
emotional and mental toll from wondering whether a treatment will be
successful, going through the actual treatment, and inability to do
normal activities or work will most likely be high. This emotional and
mental toll will extend to the person's family and friends as they
struggle with the diagnosis and success and failure of a treatment
regime. If a person has children, this could affect their mental and
emotional well-being and may impact their success in school. A
discussion of the monetized benefits associated with reducing risk of
NHL is located in Unit VIII.B. The estimated value of the annualized
benefit is $759,000 to $1.2 million for aerosol degreasing and $3.9
million to $10.1 million for spot cleaning in dry cleaning facilities
at 3% over 15 years; and $355,000 to $601,000 for aerosol degreasing
and $1.8 million to $5.0 million for spot cleaning in dry cleaning
facilities at 7% over 15 years.
    4. Reproductive and endocrine effects. The TCE risk assessment
identified chronic non-cancer risks for reproductive effects for
workers and bystanders exposed to TCE. There are increased health risks
for reproductive effects for the approximately 10,800 workers and
occupational bystanders at commercial aerosol degreasing operations and
the up to approximately 168,000 workers and occupational bystanders in
dry cleaning operations (Ref. 2).
    The reproductive effect for both females and males can be altered
libido. The prevalence of infertility is estimated at about 10-15% of
couples with a decreased libido among the factors of infertility (Ref.
56). For females, there can be reduced incidence of fecundability (6.7
million women ages 15 to 44 or 10.9% affected) (Ref. 57), increase in
abnormal menstrual cycle, and amenorrhea (the absence of menstruation).
Reproductive effects on males can be decreased potency, gynaecomastia,
impotence, and decreased testosterone levels, or low T levels.
Approximately 2.4 million men age 40 to 49 have low T levels, with a
new diagnosis of about 481,000 androgen deficiency cases a year. Other
estimates propose a hypogonadism prevalence of about 13 million
American men (Ref. 58). Low T levels are associated with aging; an
estimated 39% of men 45 or older have hypogonadism, resulting in low T
levels (Ref. 59). Hormone therapy and endocrine monitoring may be
required in the most severe cases. Low T levels are associated with
aging; an estimated 39% of men 45 or older have hypogonadism, resulting
in low T levels (Ref. 59). Hormone therapy and endocrine monitoring may
be required in the most severe cases.
    The monetary costs of these potential reproductive effects involve
doctor's visits in order to try to determine why there is a change. In
some instances, a person or couple may need to visit a fertility
doctor.
    The impact of a reduced sex drive can take an emotional and mental
toll on single people as well as couples. For people trying to get
pregnant, decreased fertility can add stress to a relationship as the
cause is determined and avenues explored to try to resolve the
difficulties in conceiving. A person or couples' quality of life can
also be affected as they struggle with a reduced sex drive. Similar to
effects discussed previously, 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, the Agency still
considers their impact.
    5. Neurotoxicity. The TCE risk assessment identified chronic risks
for neurotoxicity for workers and bystanders. There are increased
health risks for neurotoxicity to the approximately 10,800 workers and
bystanders at commercial aerosol degreasing operations and the up to
approximately 168,000 workers and bystanders in dry cleaning operations
(Ref. 2).
    Studies have also demonstrated neurotoxicity for acute exposure.
Neurotoxic effects observed are alterations in trigeminal nerve and
vestibular function, auditory effects, changes in vision, alterations
in cognitive function, changes in psychomotor effects, and
neurodevelopmental outcomes. Developmental neurotoxicity effects are
delayed newborn reflexes, impaired learning or memory, aggressive
behavior, hearing impairment, speech impairment, encephalopathy,
impaired executive and motor function and attention deficit (Ref. 3).
    The impacts of neurotoxic effects due to TCE exposure can last a
person's entire lifetime. Changes in vision may impact a person's
ability to drive, which can create difficulties for daily life.
Impaired learning or memory, aggressive behavior, hearing impairment,
speech impairment, encephalopathy, impaired executive and motor
function and attention deficit can impact a child's educational
progression and adolescent's schooling and ability to make friends,
which in turn can impact the type of work or ability get work later in
life.
    Neurotoxicity in adults can affect the trigeminal nerve, the
largest and most complex of the 12 cranial nerves, which supplies
sensations to the face, mucous membranes, and other structures of the
head. Onset of trigeminal neuralgia generally occurs in mid-life and
known causes include multiple sclerosis, sarcoidosis and Lyme disease.
There is also a co-morbidity with scleroderma and systemic lupus. Some
data show that the prevalence of trigeminal neuralgia could be between
0.01% and 0.3% (Ref. 60). Alterations to this nerve function might
cause sporadic and sudden burning or shock-like facial pain to a
person. One way to relieve the burning or shock-like facial pain is to
undergo a procedure where the nerve fibers are damaged in order to
block the pain. This treatment can have lasting impact on sensation
which may also be deleterious for normal pain sensation. The potential
side effects of this procedure includes facial numbness and some
sensory loss.
    The monetary health costs can range from doctor's visits and
medication to surgeries and hospital stays. Depending upon when the
neurotoxic effect occurred, the monetary costs may encompass a person's
entire lifetime or just a portion.
    The personal costs (emotional, mental, and impacts to a person's
quality of life) cannot be discounted. Parents of a child with impaired
learning, memory, or some other developmental neurotoxic effect may
suffer emotional and mental stress related to worries about the child's
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 what is wrong. 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 neurotoxicity 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 10,800
workers occupational bystanders at commercial aerosol degreasing
operations and the up to approximately 168,000 workers and occupational
bystanders in dry cleaning operations (Ref. 1).
    Specific effects to the liver can include increased liver weight,
increase in DNA synthesis (transient), enlarged hepatocytes, enlarged
nuclei, and peroxisome proliferation (Ref. 1). In addition, workers
exposed to TCE have shown hepatitis accompanying immune-related
generalized skin diseases, jaundice, hepatomegaly, hepatosplenomegaly,
and liver failure (Ref. 1).
    Some form of liver disease impacts at least 30 million people, or 1
in 10 Americans (Ref. 61). Included in this number is at least 20% of
those with nonalcoholic fatty liver disease (NAFLD) (Ref. 61). NAFLD
tends to impact people who are overweight/obese or have diabetes.
However, an estimated 25% do not have any risk factors (Ref. 61). 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. 61). 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. 62). 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. 62). 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. 62). These known
environmental risk factors of hepatitis infection may result in
increased susceptibility of individuals exposed to organic chemicals.
    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. 3). 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. 3).
    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 $493,000 to $811,000 for
aerosol degreasing and $2.5 million to $6.7 million for spot cleaning
in dry cleaning facilities at 3% over 15 years; and $252,000 to
$436,000 for aerosol degreasing and $1.3 million to $3.6 million for
spot cleaning in dry cleaning facilities at 7% over 15 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.
63). 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.
    7. Disproportionate impacts on environmental justice communities.
An additional factor that cannot be monetized is the disproportionate
impact on environmental justice communities. Asian and Hispanic
populations are disproportionately represented in dry cleaning
facilities. 13% of dry cleaning workers are Asian, compared to 5% of
the national population, and 30% of dry cleaning workers are Hispanic
(of any race), compared to 16% of the national population, indicating
that these two populations are over-represented. Because they are
disproportionately over-represented in the dry cleaning industry, these
populations are disproportionately exposed to TCE during spot cleaning
in dry cleaning facilities and disproportionately at risk to the range
of adverse non-cancer effects and cancer.

B. Monetized Benefits of the Proposed Rule and the Alternatives That
EPA Considered

    The benefits that can be monetized from risk reductions due to the
proposed prohibitions on manufacture, processing, and distribution in
commerce of TCE for aerosol degreasing, and the prohibition on
commercial use of TCE in aerosol degreasing are estimated to be $1.5
million to $2.7 million (annualized at 3% over 15 years) and $700,000
to $1.4 million (annualized at 7% over 15 years). The monetized
benefits from similar prohibitions to mitigate the risks from TCE for
spot cleaning in dry cleaning facilities are estimated to be $7.8
million to $22.3 million (annualized at 3% over 15 years) and $3.7
million to $11.4 million (annualized at 7% over 15 years). The total
monetized benefits for the proposed rule range from approximately $9.2
million to $24.8 million on an annualized basis over 15 years at 3% and
$4.4 million to $12.6 million at 7%. The alternatives considered are
unlikely to result in the same health benefits as the proposed rule for
the reasons discussed in Units VI and VII. However, EPA was unable to
quantify the differences in benefits that would result from the
alternatives.

C. 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
aerosol degreasing are discussed in Unit VI.C.1 and the details of the
costs of the proposed approach for spot cleaning in dry cleaning
facilities are discussed in Unit VII.C.1. Under the proposed option,
costs to users of aerosol degreasers are negligible as substitute
products are currently available on the market and are similarly
priced. Total costs of aerosol degreasing product reformulations are
estimated to be approximately $416,000 in the first year and $32,000
per year (annualized at 3% over 15 years) and $41,000 (annualized at 7%
over 15 years). Costs of downstream notification and recordkeeping are
estimated to be $51,000 in the first year and on an

annualized basis over 15 years are $3,900 and $5,000 using 3% and 7%
discount rates respectively. Agency costs for enforcement are estimated
to be approximately $112,000 and $109,000 annualized over 15 years at
3% and 7%, respectively. The total cost of the proposed approach for
the aerosol degreasing use is estimated to be $37,000 to $40,000 and
$46,000 to $49,000 annualized over 15 years at 3% and 7%, respectively.
Annual recurring costs to the Agency for enforcement are estimated to
be $121,000 per year.
    Under the proposed approach, dry cleaners are expected to switch to
alternatives because they are readily available at similar cost and
performance. Blenders of TCE spot cleaners are expected to reformulate
their products. Total costs of reformulation are estimated to be
$286,000 in the first year and annualized costs are approximately
$22,000 per year (annualized at 3% over 15 years) and $28,000
(annualized at 7% over 15 years). Costs of downstream notification and
recordkeeping are estimated to be $51,000 in the first-year and on an
annualized basis over 15 years are $3,900 and $5,000 using 3 and 7
percent discount rates respectively. Agency costs for enforcement are
estimated to be approximately $112,000 to $109,000 annualized over 15
years at 3% and 7%. Annual recurring costs to the Agency for
enforcement are estimated to be $121,000 per year. The total cost of
the proposed approach for the dry cleaning spotting use is estimated to
be $130,000-$133,000 and $135,000-$137,000 annualized over 15 years at
3% and 7%, respectively.
    Total costs of the proposed rule for both uses are estimated to be
$170,000 annualized over 15 years at 3% and $183,000 annualized over 15
years at 7%.
    Alternatives that EPA considered include the use of PPE as well as
an option that would prohibit the use of TCE in aerosol degreasing and
as a spot cleaner at dry cleaning facilities, without the companion
prohibition on manufacture, processing, or distribution in commerce for
these uses or the downstream notification requirements. As discussed in
Unit VI., EPA assumed that no users would adopt PPE because the per-
facility costs were prohibitively expensive. The estimated annualized
costs of switching to a respiratory protection program requiring PPE of
10,000 are $8,200 at 3% and $9,000 at 7% per dry cleaning facility and
$8,300 at 3% and $9,100 at 7% per aerosol degreasing facility over 15
years. EPA also found that a use prohibition alone without downstream
notification requirements would not address the identified unreasonable
risks. EPA estimated the costs of this option to be $166,000 annualized
over 15 years at 3% and $178,000 annualized over 15 years at 7%.

D. Comparison of Benefits and Costs

    The monetized benefits for preventing the risks resulting from TCE
exposure from both these uses significantly outweigh the estimated
costs. Even though simply comparing the costs and monetized benefits of
prohibiting the manufacture, processing, and distribution in commerce
of TCE as an aerosol degreaser; prohibiting its use as an aerosol
degreaser; and requiring downstream notification demonstrates that the
monetized benefits of this proposed action outweigh the costs, 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
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 making its determination
about how best to address the unreasonable risks presented by TCE use
in aerosol degreasing and as a spot cleaner in dry cleaning facilities.
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, emotional
and psychological costs, and the disproportionate impacts on Asian and
Hispanic communities, the benefits of preventing TCE exposure 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 aerosol degreasing (the annualized monetized benefits on
a 15 year basis range from approximately $1.5 million to $2.7 million
at 3% and $700,000 to $1.4 million at 7%) and the use of TCE in spot
cleaners in dry cleaning facilities (the annualized monetized benefits
on a 15 year basis range from approximately $7.8 million to $22.3
million at 7% and $3.7 million to $11.4 million at 3%) far outweigh the
costs of the proposed approaches for use of TCE in aerosol degreasing
(the annualized costs on a 15 year basis range from approximately
$37,000 to $40,000 at 3% and $46,000 to $49,000 at 7%) and for use of
TCE in spot cleaners in dry cleaning facilities (the annualized costs
on a 15 year basis range from approximately $130,000 to $133,000 at 3%
and $135,000 to $137,000 at 7%).

IX. Overview of Uncertainties

    A discussion of the uncertainties associated with this proposed
rule can be found in the TCE risk assessment (Ref. 1) and in the
supplemental analysis (Refs. 23, 24, 25) for use of TCE in aerosol
degreasing and use of TCE for spot cleaning in dry cleaning facilities.
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 and consumer
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: (1) Releases of and exposures to

TCE can vary from one aerosol degreasing activity 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 aerosol degreasing, there are uncertainties in the number of
workers exposed to TCE and in the inputs to the models used to estimate
exposures. (2) Although EPA found information about TCE products
intended for consumer use, there is some general uncertainty regarding
the nature and extent of the consumer use of aerosol products
containing TCE. (3) Releases of and exposures to TCE can vary from one
dry cleaning facility to the next. EPA attempted to quantify this
uncertainty by evaluating multiple scenarios to establish a range of
releases and exposures. There is also uncertainty in the number of
workers exposed to TCE for spot cleaning in dry cleaning facilities.
There are uncertainties in the model and inputs used to model the
exposures to TCE from these uses.
    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 reliance on professional judgment to estimate the alternatives that
users might choose to adopt and the potential risks for adverse health
effects that the alternatives may pose. 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 does not
include any benefits for firms that switch to anything other than
water-based, methyl ester (soy-based) cleaners, or acetone degreasers.
The higher benefits estimate includes the benefit from entirely
eliminating TCE exposure for all alternative compliance strategies and
assumes that no risks are introduced by alternatives. 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.
    There are also uncertainties in the estimates of the number of
affected facilities, particularly those for the aerosol degreasing use
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 aerosol degreasers is
based on EPA calculations using data derived from the California Air
Resources Board Initial Statement of Reasons for the Proposed Airborne
Toxic Control Measure for Emissions of Chlorinated Toxic Air
Contaminants from Automotive Maintenance and Repair Activities (Ref.
2). 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 include
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. 2).
    Another uncertainty concerns the estimate for the cost of
reblending products and the time required to reblend those products.
EPA used a study on the automotive aftermarket parts products industry
that provided a range of costs for product reformulation and used the
mean value of $26,000 from that study. EPA contacted both dry cleaners
and blenders of aerosol degreasing products for additional information
and received a few estimates from the aerosol degreasing product
blenders which ranged from $15,000 to $30,000. However, EPA received no
information from dry cleaning spot cleaning product blenders, so there
is some uncertainty as to how representative the estimate is for that
industry.
    EPA also assumes that companies are generally able to reblend
products within 6 months following publication of the final rule;
however, it is not certain whether they may experience additional costs
if they are not able have a product available to market at that time.
    EPA will consider additional information received during the public
comment period, including comments on implementation timeframes. This
includes public comments, scientific publications, and other input
submitted to EPA during the comment period.

X. Analysis Under Section 9 of TSCA (Other Authorities) for Aerosol
Degreasing and Spot Cleaning in Dry Cleaning Facilities and TSCA
Section 26(h) Considerations

A. Section 9 Analysis

    1. Section 9(a) analysis. Section 9(a) of TSCA provides that, if
the Administrator determines in her discretion that unreasonable risks
may be prevented or reduced to a sufficient extent by 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 unreasonable risks or if that agency initiates action under its
own law to protect against the risk, EPA is precluded from acting
against the risk under sections 6 or 7 of TSCA.
    Section 9(d) of TSCA 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 today's proposed rule, EPA has
consulted with CPSC and OSHA.
    CPSC protects the public from unreasonable risks of injury or death
associated with the use of consumer products under the agency's
jurisdiction. There are no CPSC regulations on use of TCE in aerosol
degreasers and for spot cleaning at dry cleaning facilities (Ref. 64).
    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 American
Conference of Governmental Industrial Hygienists (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. 9).

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 aerosol degreasing or for spot cleaning in dry cleaning
facilities (Ref. 9).
    EPA has determined that risks from the use of TCE in aerosol spray
degreasers and as a spot cleaner in dry cleaning facilities are best
managed by regulation under TSCA rather than by referral to other
agencies. Today's proposed rule addresses risk from TCE exposure to
populations in both workplaces and consumer settings. 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
proposed rulemaking under TSCA. 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 TCE risk, such as consumer
products. And neither agency has authority to bar the manufacture,
processing or distribution for these uses and require downstream
notification of restrictions like EPA proposes to do.
    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 (FHSA), 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 these uses of TCE so that the risks are no
longer unreasonable 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,
October 10, 2014). But under TSCA, EPA's substantive burden under TSCA
section 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 non-risk
factors.
    TSCA is the only regulatory authority able to prevent or reduce
risk 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. Accordingly, EPA determines that referral to other Federal
authorities for risk management would not necessarily address the
unreasonable risk. As noted previously, 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 these
uses of TCE may be prevented or reduced to a sufficient extent by an
action taken under a Federal law not administered by EPA.
    2. Section 9(b) analysis. If EPA determines that actions under
other Federal authorities administered in whole or in part by EPA may
eliminate or sufficiently reduce unreasonable risks, section 9(b) of
TSCA instructs EPA to use these other statutes 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 determination, section 9(b)(2) of TSCA 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 chemicals
substances.

B. Section 26(h) Considerations

    In proposing this rule under section 6 of TSCA, the EPA has made a
decision based on science. EPA has used scientific information,
technical procedures, measures, methods, protocols, methodologies, and
models consistent with the best available science. Specifically, EPA
based its preliminary determination of unreasonable risk presented by
the use of TCE in aerosol degreasing products and as a spot cleaner in
dry cleaning facilities on the completed risk assessment, which
followed a peer review and public comment process, as well as using
best available science and methods (Ref. 1). 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.
    The scientific information and technical measures and models used
in the risk assessment and supplemental analyses are consistent with
the intended use for risk reduction by regulation under section 6 of
TSCA. The degree of clarity and completeness of

the science used in the risk assessment and supplemental analyses are
described in the risk assessment (Ref. 1) and Unit IX. Similarly, the
variability and uncertainty in the information or models and methods
used are described in the risk assessment (Ref. 1) and Unit IX.

XI. Major Provisions of the Proposed Rule

A. Prohibitions on TCE Manufacturing, Processing, Distribution in
Commerce, and Commercial Use

    The rule would prohibit (1) the manufacture, processing,
distribution in commerce, and commercial use of TCE in aerosol
degreasers; and (2) the manufacture, processing, distribution in
commerce, and use of TCE for spot cleaning in dry cleaning facilities.

B. Downstream Notification

    EPA has authority under section 6 of TSCA to require that a
substance or mixture or any article containing such substance or
mixture be marked with or accompanied by clear and adequate minimum
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 proposed rule. 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. EPA is proposing a requirement for downstream
notification by manufacturers, processors, and distributors of TCE for
any use to ensure compliance with the prohibition on manufacture,
processing, distribution in commerce, and commercial use of TCE for
spot cleaning in dry cleaning facilities and in aerosol degreasers.
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 the use of TCE for spot cleaning in dry cleaning
facilities and in aerosol degreasers, which is likely to decrease
unintentional uses of TCE by these entities. Downstream notification
represents minimal burden and is necessary for effective enforcement of
the rule. The estimated cost of downstream notification is $51,000 in
the first year and $3,900 and $5,000 on an annualized basis over 15
years using 3 and 7 percent discount rates respectively.

C. 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 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 section 11 of TSCA.
    Violators may be subject to both civil and criminal liability.
Under the penalty provision of section 16 of TSCA, any person who
violates 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 for each
day of violation and imprisonment. In addition, other remedies are
available to EPA under TSCA.
    Individuals, as well as corporations, could be subject to
enforcement actions. Sections 15 and 16 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.

XII. 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.

1. EPA. 2014. TSCA Work Plan Chemical Risk Assessment.
Trichloroethylene: Degreasing, Spot Cleaning and Arts & Crafts Uses.
CASRN: 79-01-6. 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-0
2. EPA (US Environmental Protection Agency). 2016. Economic
Assessment for Trichloroethylene (TCE) under TSCA Section 6. Office
of Chemical Safety and Pollution Prevention, Washington, DC.
3. EPA. Toxicological Review of Trichloroethylene (CAS No. 79-01-6).
EPA/635/R-09/011F. Integrated Risk Information System, Washington,
DC. 2011.
4. International Agency for Research on Cancer. Monographs on the
Evaluation of Carcinogenic Risks to Humans: Cadmium,
Trichloroethylene, Tetrachloroethylene, and Some Chlorinated Agents.
Volume 106. World Health Organization, Lyon, France.
5. National Toxicology Program. 13th Report on Carcinogens. 2014.
Available at http://ntp.niehs.nih.gov/annualreport/2015/glance/roc/index.html.
6. EPA. Protection of Stratospheric Ozone: Listing of Ozone-
Depleting Substances-n-Propyl Bromide in Solvent Cleaning. Final
Rule. Federal Register (72 FR 30142, May 30, 2007) (FRL-8316-8).
7. Occupational Safety and Health Administration (OSHA).
Occupational Safety and Health Standards, Toxic and Hazardous
Substances. Code of Federal Regulations 29 CFR 1910.1000. 1998.
8. OSHA. Permissible Exposure Limits--Annotated Tables. https://www.osha.gov/dsg/annotated-pels/. Retrieved February 26, 2016.
9. OSHA. Chemical Management and Permissible Exposure Limits (PELs).
Federal Register 79 FR 61384 (October 10, 2014). http://www.regulations.gov/#!documentDetail;D=OSHA-2012-0023-0001
10. National Institute for Occupational Safety and Health (NIOSH).
Pocket Guide to Chemical Hazards. U.S. Department of Health and
Human Services, Public Health Service, Centers for Disease Control
and Prevention. Cincinnati, OH. 1997.
11. American Conference of Governmental Industrial Hygienists
(ACGIH), Threshold Limit Values & Biological Exposure Indices for
2003, ACGIH, Cincinnati, OH, 2003.
12. Cal. Code Regs. tit. 17, Sec.  94509 (2013).
13. Toxics Use Reduction Institute (TURI). http://www.turi.org/TURI_Publications/TURI_Chemical_Fact_Sheets/Trichloroethylene_TCE_Fact_Sheet. 2013.
14. Minnesota Department of Health. Chemicals of High Concern List.
July 1, 2013. http://www.health.state.mn.us/divs/eh/hazardous/topics/toxfreekids/chclist/mdhchc2013.pdf.
15. LawAtlas: The Policy Surveillance Portal. http://lawatlas.org/.
Retrieved April 4, 2016.
16. European Chemicals Agency. Substance Information:
Trichloroethylene. http://echa.europa.eu/da/substance-information/-/substanceinfo/100.001.062. Retrieved February 25, 2016.
17. Environment Canada. Priority Substances List Assessment Report-

Trichloroethylene. Canada Environmental Protection Act. 1993. http://www.hc-sc.gc.ca/ewh-semt/pubs/contaminants/psl1-lsp1/trichloroethylene/index-eng.php. Retrieved March 7, 2016.
18. Environment Canada. Solvent Degreasing Regulations (SOR/2003-
283) http://www.ec.gc.ca/lcpe-cepa/eng/regulations/detailreg.cfm?intReg=76. Retrieved March 7, 2016.
19. Incorporated Administrative Agency National Institute of
Technology and Evaluation. Chemical Risk Information Platform
(CHRIP). http://www.safe.nite.go.jp/english/sougou/view/ComprehensiveInfoDisplay_en.faces. Retrieved March 7, 2016.
20. Australian Government Department of Health National Industrial
Chemicals Notification and Assessment Scheme. AICS Listing. http://www.nicnas.gov.au/regulation-and-compliance/aics/aics-search-page/chemical?id=1092. Retrieved March 7, 2016.
21. EPA. TSCA Work Plan Chemicals: Methods Document. Environmental
Protection Agency Office of Pollution Prevention and Toxics.
Washington, DC February 2012. http://www.epa.gov/sites/production/files/2014-03/documents/work_plan_methods_document_web_final.pdf.
Retrieved February 25, 2016.
22. EPA. TSCA Work Plan Chemicals. Office of Chemical Safety and
Pollution Prevention. June 2012. http://www.epa.gov/sites/production/files/2014-02/documents/work_plan_chemicals_web_final.pdf. Retrieved February 25, 2016.
23. EPA. Supplemental Occupational Exposure and Risk Reduction
Technical Report in Support of Risk Management Options for
Trichloroethylene (TCE) Use in Aerosol Degreasing. Office of
Chemical Safety and Pollution Prevention. Washington, DC 2016.
24. EPA. Supplemental Exposure and Risk Reduction Technical Report
in Support of Risk Management Options for Trichloroethylene (TCE)
Use in Consumer Aerosol Degreasing. Office of Chemical Safety and
Pollution Prevention. Washington, DC 2016.
25. EPA. Supplemental Occupational Exposure and Risk Reduction
Technical Report in Support of Risk Management Options for
Trichloroethylene (TCE) Use in Spot Cleaning. Office of Chemical
Safety and Pollution Prevention. Washington, DC February 29, 2016.
26. EPA. A Review of the Reference Dose and Reference Concentration
Processes. EPA/630/P-02/002F. December 2002.
27. EPA. Expert Public Workshop on Alternatives and Risk Reduction
Approaches to Trichloroethylene. July 29-30, 2014. EPA Docket Number
EPA-HQ-OPPT-2014-0327-0001.
28. EPA. Regulatory Options Analysis Matrix for TCE Aerosol
Degreasing [RIN 2070-AK03]. Office of Chemical Safety and Pollution
Prevention. Washington, DC 2016.
29. EPA. Regulatory Options Analysis Matrix for TCE as a Spot
Cleaner (Dry Cleaning). [RIN 2070-AK03]. Office of Chemical Safety
and Pollution Prevention. Washington, DC 2016.
30. OSHA. Respiratory Protection. https://www.osha.gov/SLTC/respiratoryprotection/index.html. Retrieved March 16, 2016.
31. Consumer Specialty Products Association (CSPA). Presentation by
Steven Bennett at the Expert Public Workshop on Alternatives and
Risk Reduction Approaches to Trichloroethylene. July 29, 2014.
32. EPA. Analysis Report of Alternatives in Support of Risk
Management Options for Use of TCE in Aerosol Degreasing and for Spot
Cleaning in Dry Cleaning Facilities. Office of Chemical Safety and
Pollution Prevention. Washington, DC 2016.
33. Unintended pregnancy in the United States: Incidence and
disparities, 2006. Contraception. 2011;84(5):478-485.
34. EPA. Guidelines for Developmental Toxicity Risk Assessment.
Federal Register 56(234):63798-63826. December 5, 1991.
35. EPA. Guidelines for Reproductive Toxicity Risk Assessment.
Federal Register 61(212):56274-56322. October 31, 1996.
36. Johnson, P.D., S.J. Goldberg, M.Z. Mays, and B.V. Dawson. 2003.
Threshold of Trichloroethylene Contamination in Maternal Drinking
Waters Affecting Fetal Heart Development in the Rat. Environmental
Health Perspectives, 111(3), 289-292.
37. EPA. The Effectiveness of Labeling on Hazardous Chemicals and
Other Products. Office of Chemical Safety and Pollution Prevention.
Washington, DC 2016.
38. United States Consumer Product Safety Commission (CPSC). Human
Factors Assessment of Strong Magnet Sets. Bethesda, MD. August 2,
2012.
39. EPA. Recommendations for an Existing Chemical Exposure Limit
(ECEL) for Occupational Use of Trichloroethylene (TCE) and Sampling
and Analytical Methods for TCE. Office of Chemical Safety and
Pollution Prevention. Washington, DC August 28, 2015.
40. Hindin, David A., and Jon D. Silberman. Designing More Effective
Rules and Permits. George Washington Journal of Energy &
Environmental Law. 7.2 (2016): 103-23.
41. EPA. Proceedings Report-Stakeholder Roundtables. United States-
Canada Regulatory Cooperation Council: Supply Chain Communication
and the U.S. EPA's SNUR and EC/HC's SNAc Programs. November 30,
2015.
42. Dry Cleaning Coalition. State Coalition for Remediation of
Drycleaners: Chemicals Used In Dry Cleaning Operations. 2009.
43. EPA. November 13, 2014, Meeting with The Drycleaning and Laundry
Institute.
44. EPA. Evaluation of Water-Based Cleaners. Office of Chemical
Safety and Pollution Prevention. Washington, DC 2016.
45. NIOSH (National Institute for Occupational Safety and Health).
Control of Spotting Chemical Hazards in Commercial Drycleaning.
Publication Number 97-158. Centers for Disease Control and
Prevention, Atlanta, GA. http://www.cdc.gov/niosh/docs/hazardcontrol/hc20.html.
46. CDC. Facts about Congenital Heart Defects http://www.cdc.gov/ncbddd/heartdefects/facts.html. December 22, 2015. Accessed March 1,
2016.
47. The National Academies Press, Committee on Developmental
Toxicology, Board on Environmental Studies and Toxicology,
Commission on Life Sciences, National Research Council. Scientific
Frontiers in Developmental Toxicology and Risk Assessment.
Washington, DC. http://www.nap.edu/read/9871/chapter/4. 2000.
48. Mayo clinic. Chronic kidney disease. http://www.mayoclinic.org/diseases-conditions/kidney-disease/basics/definition/con-20026778.
January 30, 2015.
49. American Kidney Fund. 2015 Kidney Disease Statistics. http://www.kidneyfund.org/about-us/assets/pdfs/kidney_disease_statistics_2015.pdf
50. The Kidney Boy. The Cost of Dialysis. http://thekidneyboy.blogspot.com/2011/01/cost-of-dialysis.html. January 20,
2011.
51. Silman AJ, Hochberg MC. Cooper C, et al. Epidemiology of the
Rheumatic Diseases. Oxford, U.K.: Oxford University Press; 1993:192.
Cited in Hinchcliff, M.; Varga, Systemic sclerosis/scleroderma: A
treatable multisystem disease. J. Am Fam Physician. 78(8):961-8.
2008.
52. 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.
53. National Cancer Institute. SEER Stat Fact Sheets: Non-Hodgkin
Lymphoma. Bethesda, MD. http://seer.cancer.gov/statfacts/html/nhl.html. Retrieved March 16, 2016.
54. Mayo Clinic. 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.
55. 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.
56. 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.
57. CDC. National Center for Health Statistics--Infertility.
February 6, 2015. http://www.cdc.gov/nchs/fastats/infertility.htm
Retrieved March 16, 2016.

58. Gruenewald DA, Matsumoto AM. Testosterone supplementation
therapy for older men: Potential benefits and risks. J Am Geriatr
Soc. 2003;51(1):101-115.
59. Dadona P, Rosenberg MT. A practical guide to male hypogonadism
in the primary care setting. Int J Clin Pract. 2010;64(6):682-696.
60. International Association for the Study of Pain. http://www.iasp-pain.org/files/Content/ContentFolders/GlobalYearAgainstPain2/20132014OrofacialPain/FactSheets/Trigeminal_Neuralgia.pdf. 2013.
61. American Liver Foundation. Non-Alcoholic Fatty Liver Disease
(NAFLD). http://www.liverfoundation.org/abouttheliver/info/nafld/.
January 14, 2015. Retrieved April 4, 2016.
62. CDC. Viral Hepatitis--Statistics and Surveillance. http://www.cdc.gov/hepatitis/Statistics/index.htm. May 31, 2014. Retrieved
April 4, 2016.
63. United Network for Organ Sharing (UNOS) Transplant Living.
Financing a Transplant--Costs. December 28, 2011. Available at
http://transplantliving.org/before-the-transplant/financing-a-transplant/the-costs/. Retrieved March 16. 2016.
64. United States Consumer Product Safety Commission (CPSC). Letter
to James J. Jones from Patricia H. Adkins. April 19, 2016.
65. Occupational Safety and Health Administration (OSHA). Letter to
James J. Jones from David Michaels. April 4 2016.
66. EPA. Section 6(a) Rulemakings under the Toxic Substances Control
Act (TSCA) Paint Removers & TCE Rulemakings E.O. 13132: Federalism
Consultation. May 13, 2015.
67. 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.

XIII. 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 a significant regulatory action because it may raise
novel legal or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in Executive Order
12866 (58 FR 51735, October 4, 1993). Accordingly, EPA submitted the
action to the Office of Management and Budget (OMB) for review under
Executive Order 12866 and Executive Order 13563 (76 FR 3821, January
21, 2011), and 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 VIII. (Ref. 2).

B. Paperwork Reduction Act (PRA)

    The information collection requirements in this proposed rule have
been submitted to OMB for review and comment under the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq. The Information Collection
Request (ICR) document prepared by the EPA has been assigned the EPA
ICR number 2541.01. You can find a copy of the ICR in the docket for
this proposed rule, 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 two 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 the
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 the
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 January 17, 2017. The EPA will respond to any ICR-related
comments in the final rule.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. The small entities subject to the requirements of
this action are blenders of TCE-containing dry cleaning spot removers
and aerosol degreasers, users of dry cleaning spot removers and aerosol
degreasers, and manufacturers, processors, and distributors of non-
prohibited TCE-containing products. Users of these products are not
expected to experience costs as there are currently a number of
alternatives available that are similar in performance and cost. There
are no small governmental jurisdictions or non-profits expected to be
affected by the proposed rule. Overall, EPA estimates there are
approximately 51,000 small entities affected by the proposed rule.
    Comparing the total annualized compliance cost for companies to
their revenue, the Agency has estimated that all companies are expected
to have cost impacts of less than one percent of their revenues,
ranging from an estimated high of 0.3 percent of revenues to a low of
0.01 percent of revenues. Details of this analysis are presented in the
Economic Analysis for this proposed rule (Ref. 2).

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 manufacturers, processors, and
distributors of TCE. The total estimated annualized cost of the
proposed rule is approximately

$170,000 at 3% and $183,000 at 7% (Ref. 2).

E. Executive Order 13132: Federalism

    The 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. 65).
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,
E.O. 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. 66). EPA also met with the National Tribal Toxics
Council (NTTC) in Washington, DC and via teleconference on April 22,
2015 (Ref. 66). 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 not subject to Executive Order 13045 because it is
not economically significant as defined in Executive Order 12866. This
action's health and risk assessment of TCE exposure on children are
contained in Units VI.B.1.c and VII.B.1.c of this preamble. Supporting
information on the exposures and health effects of TCE exposure on
children is also available in the Toxicological Review of
Trichloroethylene (Ref. 3) and the TCE risk assessment (Ref. 1).

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.

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 VI.B., VII.B, and VIII. 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 notification, Hazardous
substances, Import certification, Trichloroethylene, Recordkeeping.

    Dated: December 6, 2016,
Gina McCarthy,
Administrator.

0
Therefore, it is that 40 CFR chapter I, subchapter R, is proposed to be
amended by adding a new part 751 to read as follows:

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

Subpart A--General Provisions
Sec.
751.1 Purpose.
751.5 Definitions.
751.7 Exports and imports.
751.9 Enforcement and Inspections.
Subpart B--[Reserved]
Subpart C--[Reserved]
Subpart D--Trichloroethylene
751.301 General.
751.303 Definitions.
751.305 Aerosol Degreasing.
751.307 Spot Cleaning in Dry Cleaning Facilities.
751.309 [Reserved].
751.311 Downstream Notification.
751.313 Recordkeeping.

    Authority:  15 U.S.C. 2605.

Subpart A--General Provisions

Sec.  751.1  Purpose.

    This part sets forth requirements, such as prohibitions concerning
the manufacture (including import), processing, distribution in
commerce, uses, and/or disposal of certain chemical substances and
mixtures under section 6(a) of the Toxic Substances Control Act, 15
U.S.C. 2605(a).

Sec.  751.5  Definitions.

    The definitions in section 3 of the Toxic Substances Control Act,
15 U.S.C. 2602, apply to this part except as otherwise established in
any subpart under this part.
    Act or TSCA means the Toxic Substances Control Act, 15 U.S.C. 2601
et seq.
    CASRN means Chemical Abstracts Service Registry Number.
    EPA means the U.S. Environmental Protection Agency.
    Person means any natural person, firm, company, corporation, joint
venture, partnership, sole proprietorship, association, or any other
business entity; any State or political

subdivision thereof; any municipality; any interstate body; and any
department, agency, or instrumentality of the Federal Government.

Sec.  751.7  Exports and imports.

    (a) Exports. Persons who intend to export a chemical substance
identified in any subpart under this part, or in any proposed rule
which would amend any subpart under this part, are subject to the
export notification provisions of section 12(b) of the Act. The
regulations that interpret section 12(b) appear at 40 CFR part 707,
subpart D.
    (b) Imports. Persons who import a substance identified in any
subpart under this part are subject to the import certification
requirements under section 13 of the Act, which are codified at 19 CFR
12.118 through 12.127. See also 19 CFR 127.28.

Sec.  751.9  Enforcement and Inspections.

    (a) Enforcement. (1) Failure to comply with any provision of this
part is a violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Failure or refusal to establish and maintain records or to
permit access to or copying of records, as required by the Act, is a
violation of section 15 of the Act (15 U.S.C. 2614).
    (3) Failure or refusal to permit entry or inspection as required by
section 11 of the Act (15 U.S.C. 2610) is a violation of section 15 of
the Act (15 U.S.C. 2614).
    (4) Violators may be subject to the civil and criminal penalties in
section 16 of the Act (15 U.S.C. 2615) for each violation.
    (b) Inspections. EPA will conduct inspections under section 11 of
the Act (15 U.S.C. 2610) to ensure compliance with this part.

Subpart B--[Reserved]

Subpart C--[Reserved]

Subpart D--Trichloroethylene

Sec.  751.301  General.

    This subpart sets certain restrictions on the manufacture
(including import), processing, distribution in commerce, and uses of
trichloroethylene (TCE) (CASRN 79-01-6) to prevent unreasonable risks
to health associated with human exposure to TCE for the specified uses.

Sec.  751.303  Definitions.

    The definitions in subpart A of this part apply to this subpart
unless otherwise specified in this section. In addition, the following
definitions apply:
    Aerosol degreasing means the use of a chemical in aerosol spray
products applied from a pressurized can to remove contaminants.
    Distribute in commerce has the same meaning as in section 3 of the
Act, except that the term does not include retailers for purposes of
Sec.  751.311 and Sec.  751.313.
    Dry cleaning facility means an establishment with one or more dry
cleaning systems.
    Dry cleaning system means a dry-to-dry machine and its ancillary
equipment or a transfer machine system and its ancillary equipment.
    Retailer means a person who distributes in commerce a chemical
substance, mixture, or article to consumer end users.
    Spot cleaning means use of a chemical to clean stained areas on
materials such as textiles or clothing.

Sec.  751.305  Aerosol Degreasing.

    (a) After [Date 180 calendar days after the date of publication of
the final rule], all persons are prohibited from manufacturing,
processing, and distributing in commerce TCE in aerosol degreasing
products and TCE for use in aerosol degreasing products.
    (b) After [Date 270 calendar days after the date of publication of
the final rule], all persons are prohibited from commercial use of TCE
in aerosol degreasing products.

Sec.  751.307  Spot Cleaning at Dry Cleaning Facilities.

    (a) After [Date 180 calendar days after the date of publication of
the final rule], all persons are prohibited from manufacturing,
processing, and distributing in commerce TCE for spot cleaning at dry
cleaning facilities.
    (b) After [Date 270 calendar days after the date of publication of
the final rule], all persons are prohibited from commercial use of TCE
for spot cleaning at dry cleaning facilities.

Sec.  751.309   [Reserved]

Sec.  751.311  Downstream Notification.

    Each person who manufactures, processes, or distributes in commerce
TCE for any use after [Date 45 calendar days after the date of
publication of the final rule] must, prior to or concurrent with the
shipment, notify companies to whom TCE is shipped, in writing, of the
restrictions described in this subpart.

Sec.  751.313  Recordkeeping.

    (a) Each person who manufactures, processes, or distributes in
commerce any TCE after [Date 45 calendar days after the date of
publication of final rule] must retain in one location at the
headquarters of the company documentation of:
    (1) The name, address, point of contact, and telephone number of
companies to whom TCE was shipped; and
    (2) The amount of TCE shipped.
    (3) Downstream notification.
    (b) The documentation in (a) must be retained for 2 years from the
date of shipment.

[FR Doc. 2016-30063 Filed 12-15-16; 8:45 am]
 BILLING CODE 6560-50-P