82_FR_7444 82 FR 7432 - Trichloroethylene (TCE); Regulation of Use in Vapor Degreasing Under TSCA Section 6(a)

82 FR 7432 - Trichloroethylene (TCE); Regulation of Use in Vapor Degreasing Under TSCA Section 6(a)

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 12 (January 19, 2017)

Page Range7432-7461
FR Document2017-01229

Trichloroethylene (TCE) is a volatile organic compound widely used in industrial and commercial processes and has some limited uses in consumer and commercial products. EPA identified significant health risks associated with TCE use in vapor degreasing and EPA's proposed determination is that these risks are unreasonable risks. To address these unreasonable risks, EPA is proposing under section 6 of the Toxic Substances Control Act (TSCA) to prohibit the manufacture (including import), processing, and distribution in commerce of TCE for use in vapor degreasing; to prohibit commercial use of TCE in vapor degreasing; to require manufacturers, processors, and distributors, except for retailers of TCE for any use, to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping.

Federal Register, Volume 82 Issue 12 (Thursday, January 19, 2017)
[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Proposed Rules]
[Pages 7432-7461]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-01229]



[[Page 7431]]

Vol. 82

Thursday,

No. 12

January 19, 2017

Part XIV





Environmental Protection Agency





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40 CFR Part 751





Trichloroethylene (TCE); Regulation of Use in Vapor Degreasing Under 
TSCA Section 6(a); Proposed Rule

Federal Register / Vol. 82 , No. 12 / Thursday, January 19, 2017 / 
Proposed Rules

[[Page 7432]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 751

[EPA-HQ-OPPT-2016-0387; FRL-9950-08]
RIN 2070-AK11


Trichloroethylene (TCE); Regulation of Use in Vapor Degreasing 
Under TSCA Section 6(a)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Trichloroethylene (TCE) is a volatile organic compound widely 
used in industrial and commercial processes and has some limited uses 
in consumer and commercial products. EPA identified significant health 
risks associated with TCE use in vapor degreasing and EPA's proposed 
determination is that these risks are unreasonable risks. To address 
these unreasonable risks, EPA is proposing under section 6 of the Toxic 
Substances Control Act (TSCA) to prohibit the manufacture (including 
import), processing, and distribution in commerce of TCE for use in 
vapor degreasing; to prohibit commercial use of TCE in vapor 
degreasing; to require manufacturers, processors, and distributors, 
except for retailers of TCE for any use, to provide downstream 
notification of these prohibitions throughout the supply chain; and to 
require limited recordkeeping.

DATES: Comments must be received on or before March 20, 2017.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2016-0387, at http://www.regulations.gov. 
Follow the online instructions for submitting comments. Once submitted, 
comments cannot be edited or withdrawn. EPA may publish any comment 
received to its public docket. Do not submit electronically any 
information you consider to be Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. 
Multimedia submissions (audio, video, etc.) must be accompanied by a 
written comment. The written comment is considered the official comment 
and should include discussion of all points you wish to make. EPA will 
generally not consider comments or comment contents located outside of 
the primary submission (i.e., on the Web, cloud, or other file sharing 
system). For additional submission methods (e.g., mail or hand 
delivery), the full EPA public comment policy, information about CBI or 
multimedia submissions, and general guidance on making effective 
comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.
    Docket. Docket ID No. EPA-HQ-OPPT-2016-0387 contains supporting 
information used in developing the proposed rule, comments on the 
proposed rule, and additional supporting information. In addition to 
being available online at http://www.regulations.gov, the docket is 
available for inspection and copying between 8:30 a.m. and 4:30 p.m., 
Monday through Friday, excluding federal holidays, at the U.S. 
Environmental Protection Agency, EPA Docket Center Reading Room, WJC 
West Building, Room 3334, 1301 Constitution Avenue NW., Washington, DC 
20004. A reasonable fee may be charged for copying.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Cindy Wheeler, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 566-0484; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this proposed action if you 
manufacture (defined under TSCA to include import), process, or 
distribute in commerce TCE or commercially use TCE in vapor degreasers. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Petroleum Refineries (NAICS code 324110).
     Petroleum Lubricating Oil and Grease Manufacturing (NAICS 
code 324191).
     Petrochemical Manufacturing (NAICS code 325110).
     Industrial Gas Manufacturing (NAICS code 325120).
     Other Basic Inorganic Chemical Manufacturing (NAICS code 
325180).
     All Other Basic Organic Chemical Manufacturing (NAICS code 
325199).
     Plastics Material and Resin Manufacturing (NAICS code 
325211).
     Synthetic Rubber Manufacturing (NAICS code 325212).
     Paint and Coating Manufacturing (NAICS code 325510).
     Adhesive Manufacturing (NAICS code 325520).
     Soap and Other Detergent Manufacturing (NAICS code 
325611).
     Polish and Other Sanitation Good Manufacturing (NAICS code 
325612).
     All Other Miscellaneous Chemical Product and Preparation 
Manufacturing (NAICS code 325998).
     Unlaminated Plastics Film and Sheet (except Packaging) 
Manufacturing (NAICS code 326113).
     All Other Plastics Product Manufacturing (NAICS code 
326199).
     Rubber and Plastics Hoses and Belting Manufacturing (NAICS 
code 326220).
     All Other Rubber Product Manufacturing (NAICS code 
326299).
     Cement Manufacturing (NAICS code 327310).
     Ground or Treated Mineral and Earth Manufacturing (NAICS 
code 327992).
     Iron and Steel Pipe and Tube Manufacturing from Purchased 
Steel (NAICS code 331210).
     Steel Wire Drawing (NAICS code 331222).
     Copper Rolling, Drawing, Extruding, and Alloying (NAICS 
code 331420)
     Nonferrous Metal (except Copper and Aluminum) Rolling, 
Drawing, and Extruding (NAICS code 331491).
     Nonferrous Metal Die-Casting Foundries (NAICS code 
331523).
     Powder Metallurgy Part Manufacturing (NAICS code 332117).
     Metal Crown, Closure, and Other Metal Stamping (except 
Automotive) (NAICS code 332119).
     Saw Blade and Hand Tool Manufacturing (NAICS code 332216).
     Metal Window and Door Manufacturing (NAICS code 332321).
     Power Boiler and Heat Exchanger Manufacturing (NAICS code 
332410).
     Other Fabricated Wire Product Manufacturing (NAICS code 
332618).
     Machine Shops (NAICS code 332710).
     Precision Turned Product Manufacturing (NAICS code 
332721).
     Bolt, Nut, Screw, Rivet, and Washer Manufacturing (NAICS 
code 332722).
     Metal Heat Treating (NAICS code 332811).
     Metal Coating, Engraving (except Jewelry and Silverware), 
and Allied Services to Manufacturers (NAICS code 332812).

[[Page 7433]]

     Electroplating, Plating, Polishing, Anodizing, and 
Coloring (NAICS code 332813).
     Oil and Gas Field Machinery and Equipment Manufacturing 
(NAICS code 333132).
     Cutting Tool and Machine Tool Accessory Manufacturing 
(NAICS code 333515).
     Small Arms, Ordnance, and Ordnance Accessories 
Manufacturing (NAICS code 332994).
     Fluid Power Pump and Motor Manufacturing (NAICS code 
333996).
     All Other Miscellaneous Fabricated Metal Product 
Manufacturing (NAICS code 332999).
     Oil and Gas Field Machinery and Equipment Manufacturing 
(NAICS code 333132).
     Industrial and Commercial Fan and Blower and Air 
Purification Equipment Manufacturing (NAICS code 333413).
     Cutting Tool and Machine Tool Accessory Manufacturing 
(NAICS code 333515).
     Pump and Pumping Equipment Manufacturing (NAICS code 
333911).
     Fluid Power Pump and Motor Manufacturing (NAICS code 
333996).
     Search, Detection, Navigation, Guidance, Aeronautical, and 
Nautical System and Instrument Manufacturing (NAICS code 334511).
     Automatic Environmental Control Manufacturing for 
Residential, Commercial, and Appliance Use (NAICS code 334512).
     Motor and Generator Manufacturing (NAICS code 335312).
     Primary Battery Manufacturing (NAICS code 335912).
     Carbon and Graphite Product Manufacturing (NAICS code 
335991).
     Motor Vehicle Brake System Manufacturing (NAICS code 
336340).
     Aircraft Manufacturing (NAICS code 336411).
     Other Aircraft Parts and Auxiliary Equipment Manufacturing 
(NAICS code 336413).
     Guided Missile and Space Vehicle Manufacturing (NAICS code 
336414).
     Ship Building and Repairing (NAICS code 336611).
     Dental Equipment and Supplies Manufacturing (NAICS code 
339114).
     Other Chemical and Allied Products Merchant Wholesalers 
(NAICS code 424690).
     Petroleum Bulk Stations and Terminals (NAICS code 424710).
     Hazardous Waste Treatment and Disposal (NAICS code 
562211).
     Solid Waste Combustors and Incinerators (NAICS code 
562213).
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Persons 
who import any chemical substance governed by a final TSCA section 6(a) 
rule are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements and the corresponding regulations at 19 CFR 
12.118 through 12.127; see also 19 CFR 127.28. Those persons must 
certify that the shipment of the chemical substance complies with all 
applicable rules and orders under TSCA. The EPA policy in support of 
import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export a chemical 
substance that is the subject of this proposed rule are subject to the 
export notification provisions of TSCA section 12(b) (15 U.S.C. 
2611(b)), and must comply with the export notification requirements in 
40 CFR part 707, subpart D.
    If you have any questions regarding the applicability of this 
proposed action to a particular entity, consult the technical 
information contact listed under FOR FURTHER INFORMATION CONTACT.

B. What is the Agency's authority for taking this action?

    Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines 
after risk evaluation that a chemical substance presents an 
unreasonable risk of injury to health or the environment, without 
consideration of costs or other non-risk factors, including an 
unreasonable risk to a potentially exposed or susceptible subpopulation 
identified as relevant to the risk evaluation, under the conditions of 
use, EPA must by rule apply one or more requirements to the extent 
necessary so that the chemical substance or mixture no longer presents 
such risk.
    For a chemical substance listed in the 2014 update to the TSCA Work 
Plan for Chemical Assessments for which a completed risk assessment was 
published prior to the date of enactment of the Frank R. Lautenberg 
Chemical Safety for the 21st Century Act, TSCA section 26(l)(4) 
expressly authorizes EPA to issue rules under TSCA section 6(a) that 
are consistent with the scope of the completed risk assessment and 
consistent with the other applicable requirements of TSCA section 6. 
TCE is such a chemical substance. It is listed in the 2014 update to 
the TSCA Work Plan and the completed risk assessment was published on 
June 25, 2014. The scope of the completed risk assessment includes 
vapor degreasing.

C. What action is the Agency taking?

    EPA's proposed determination is that the use of TCE in vapor 
degreasing presents an unreasonable risk of injury to health. 
Accordingly, EPA is proposing under TSCA section 6 to prohibit the 
manufacture (including import), processing, and distribution in 
commerce of TCE for use in vapor degreasing; to prohibit commercial use 
of TCE in vapor degreasing; and to require manufacturers, processors, 
and distributors, except for retailers, to provide downstream 
notification of this prohibition throughout the supply chain (e.g., via 
a Safety Data Sheet (SDS)), and to keep records. The application of 
this supply chain approach is necessary so that TCE no longer presents 
the identified unreasonable risks. EPA is requesting public comment on 
this proposal.
    This proposal is related to the proposed rule on TCE aerosol 
degreasing and spot cleaning in dry cleaning facilities that published 
in the Federal Register on December 16, 2016 (81 FR 91592) (FRL-9949-
86) (Ref. 1). This proposal and the earlier proposal together address 
risks for workers and consumers associated with exposure to TCE through 
inhalation that were identified in the 2014 TCE risk assessment and EPA 
intends to finalize both actions together.

D. Why is the Agency taking this action?

    Based on EPA's analysis of worker exposures to TCE, EPA's proposed 
determination is that the use of TCE in vapor degreasing presents an 
unreasonable risk to human health. More specifically, this use results 
in significant non-cancer risks under both acute and chronic exposure 
scenarios and significant cancer risks from chronic exposures. These 
adverse health effects include those resulting from 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, reproductive and endocrine 
effects (e.g., decreased libido and potency), neurotoxicity (e.g., 
trigeminal neuralgia), and toxicity to the liver (impaired functioning 
and liver cancer) (Ref. 2). TCE may cause fetal cardiac malformations 
that begin in utero. Cardiac malformations can be irreversible and 
impact a person's health for a lifetime. In addition, fetal death, 
possibly resulting from cardiac malformation, can be caused by exposure 
to TCE. In utero exposure to TCE may cause other effects, such as 
damage to the developing immune system, which manifest later in adult

[[Page 7434]]

life 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.
    As discussed in Unit I.C., EPA is not proposing to prohibit all 
manufacturing, processing, distribution in commerce, and use of TCE. As 
such, the application of this proposal's supply chain approach tailored 
to specific uses that present unreasonable risks to human health is 
necessary so that the chemical substance no longer presents the 
identified unreasonable risks.

E. What are the estimated incremental impacts of this action?

    EPA has evaluated the potential costs of multiple regulatory 
options, including the proposed approach of prohibiting the manufacture 
(including import), processing, and distribution in commerce of TCE for 
use in vapor degreasing; prohibiting the commercial use of TCE in vapor 
degreasing; and requiring manufacturers, processors, and distributors, 
except for retailers, to provide downstream notification of these 
prohibitions throughout the supply chain as well as associated 
recordkeeping requirements. This analysis (Ref. 3), which is available 
in the docket, is discussed in Unit VI., and is briefly summarized 
here.
    Alternatives to TCE with similar performance characteristics are 
readily available. Most of the costs of the rule would be borne by 
commercial users of TCE in vapor degreasing equipment, because they 
would have to switch solvents and likely equipment as well. EPA has 
estimated that the costs to users range from $30M to $45M when 
annualized over 20 years at a 3% discount rate, and from $32M to $46M 
over 20 years at a 7% discount rate. These are the total estimated 
costs of this proposal. The costs of the downstream notification and 
recordkeeping requirements to manufacturers, processors, and 
distributors of TCE, estimated to be approximately $3,200 and $4,400 
annualized over 20 years using 3% and 7% discount rates respectively. 
For additional information see Unit 5.1.3 of the Economic Analysis. 
(Ref. 3) However, because these notification and recordkeeping costs 
were already accounted for in the economic analysis accompanying the 
earlier TCE proposal (Ref. 1), they are not included in the total costs 
for this proposal. EPA accounted for these costs in the prior proposal 
because it believes the universe of entities distributing TCE for both 
sets of uses are the same. EPA is taking comment on whether the same 
firms distribute TCE for these two sets of uses.
    Although TCE causes a wide range of non-cancer adverse effects and 
cancer, monetized benefits included only benefits associated with 
reducing cancer risks. The Agency does not have sufficient information 
to include a quantification or valuation estimate for non-cancer 
benefits in the overall benefits at this time. The monetized benefits 
for the proposed approach range from approximately $65 to $443 million 
on an annualized basis over 20 years at 3% and $31 million to $225 
million at 7% (Ref. 3). The non-monetized benefits resulting from the 
prevention of the non-cancer adverse effects associated with TCE 
exposure from use in vapor degreasers include developmental toxicity, 
toxicity to the kidney, immunotoxicity, reproductive and endocrine 
effects, neurotoxicity, and toxicity to the liver (Ref. 2). Some of the 
effects that can be caused by exposure to TCE, such as cardiac 
malformations and fetal death, occur in utero and can impact a person 
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 impacts. Also see Unit VI.D.

F. Children's Environmental Health

    This action is consistent with the 1995 EPA Policy on Evaluating 
Health Risks to Children (http://www.epa.gov/children/epas-policy-evaluating-risk-children). EPA has identified women of childbearing age 
and the developing fetus as a susceptible subpopulation relevant to its 
risk assessment for TCE. After evaluating the developmental toxicity 
literature for TCE, the Integrated Risk Information System (IRIS) TCE 
assessment concluded that fetal heart malformations are the most 
sensitive developmental toxicity endpoint associated with TCE 
inhalation exposure (Ref. 4). In its TSCA Chemical Work Plan Risk 
Assessment for TCE, EPA identified developmental toxicity as the most 
sensitive endpoint for TCE inhalation exposure (i.e., fetal heart 
malformations) for the most sensitive human life stage (i.e., women of 
childbearing age between the ages of 16 and 49 years and the developing 
fetus) (Ref. 2). EPA used developmental toxicity endpoints for both the 
acute and chronic non-cancer risk assessments based on its 
developmental toxicity risk assessment policy that a single exposure of 
a chemical within a critical window of fetal development may produce 
adverse developmental effects (Ref. 5). For the identified susceptible 
subpopulations, the proposed regulatory action is protective of the 
fetal heart malformation endpoint and, for the exposed population as a 
whole, the proposal is also protective of cancer risk. In addition, the 
supporting non-cancer risk analysis of children and women of 
childbearing age conducted in the TSCA Chemical Work Plan Risk 
Assessment for TCE (Ref. 2) also meets the 1995 EPA Policy on 
Evaluating Health Risks to Children (Ref. 6). Supporting information on 
TCE exposures and the health effects of TCE exposure on children are 
also available in the IRIS Toxicological Review of Trichloroethylene 
(Ref. 4) and the TSCA Chemical Work Plan Risk Assessment on 
Trichloroethylene (Ref. 2), as well as Unit VI of this preamble.

II. Overview of TCE and the Use Subject to This Proposed Rule

A. What chemical is included in the proposed rule?

    This proposed rule applies to TCE (Chemical Abstract Services 
Registry Number 79-01-6) for use in vapor degreasing.

B. What are the uses of TCE?

    In 2011, global consumption of TCE was 945 million pounds and 
consumption in the United States was 255 million pounds. TCE is 
produced within and imported into the United States. Nine companies, 
including domestic manufacturers and importers, reported a total 
production and import of 225 million pounds of TCE in 2011 to EPA 
pursuant to the Chemical Data Reporting (CDR) rule (Ref. 2).
    The majority (about 83.6%) of TCE is used as an intermediate 
chemical for manufacturing refrigerant HFC[hyphen]134a. This use occurs 
in a closed system that has low potential for human exposure (Ref. 2). 
EPA did not assess this use and is not proposing to regulate this use 
of TCE under TSCA at this time. However, this does not mean that EPA 
found that this use or other uses not included in the TCE risk 
assessment present low risk. Much of the remainder, about 14.7%, is 
used as a solvent for degreasing of metals. A relatively small 
percentage, about 1.7%, accounts for all other uses, including TCE use 
in products, such as aerosol degreasers.
    Based on the Toxics Release Inventory (TRI) data for 2012, 38 
companies used TCE as a formulation component, 33 companies processed 
TCE by repackaging the chemical, 28 companies used TCE as a 
manufacturing aid, and 1,113 companies used TCE for ancillary uses, 
such as degreasing (Ref. 2). Based on the latest TRI data from 2014, 
the number of users of TCE has significantly

[[Page 7435]]

decreased since 2012: 24 companies use TCE as a formulation component, 
20 companies process TCE by repackaging the chemical, 20 companies use 
TCE as a manufacturing aid, and 97 companies use TCE for ancillary 
uses, such as degreasing. The TRI data does not represent all of the 
facilities manufacturing, processing, and/or using TCE because only 
certain industries and types of facilities are required to report. EPA 
estimates that there are 2,632 to 6,232 firms using TCE for vapor 
degreasing in the U.S. (Ref. 3).
    The use assessed by EPA that is the subject of this proposal, 
commercial use of TCE in vapor degreasing, is estimated to represent up 
to 14.7% of total use of TCE. This use is discussed in detail in Unit 
VI.

C. What are the potential health effects of TCE?

    A broad set of relevant studies including epidemiologic studies, 
animal bioassays, metabolism studies, and mechanistic studies show that 
TCE exposure is associated with an array of adverse health effects. TCE 
has the potential to induce developmental toxicity, immunotoxicity, 
kidney toxicity, reproductive and endocrine effects, neurotoxicity, 
liver toxicity, and several forms of cancer (Ref. 2).
    TCE is fat soluble (lipophilic) and easily crosses biological 
membranes. TCE has been found in human maternal and fetal blood and in 
the breast milk of lactating women (Ref. 2). EPA's IRIS assessment 
(Ref. 4) concluded that TCE poses a potential health hazard for non-
cancer toxicity including fetal heart malformations and other 
developmental effects, immunotoxicity, kidney toxicity, reproductive 
and endocrine effects, neurotoxicity, and liver effects. The IRIS 
assessment also evaluated TCE and its metabolites. Based on the results 
of in vitro and in vivo tests, TCE metabolites have the potential to 
bind or induce damage to the structure of deoxyribonucleic acid (DNA) 
or chromosomes (Ref. 4).
    An evaluation of the overall weight of the evidence of the human 
and animal developmental toxicity data suggests an association between 
pre[hyphen] and/or post-natal TCE exposures and potential adverse 
developmental outcomes. TCE[hyphen]induced heart malformations and 
immunotoxicity in animals have been identified as the most sensitive 
developmental toxicity endpoints for TCE. Human studies examined the 
possible association of TCE with various prenatal effects. These 
adverse effects of developmental TCE exposure may include: Death 
(spontaneous abortion, perinatal death, pre- or post-implantation loss, 
resorptions); decreased growth (low birth weight, small for gestational 
age); congenital malformations, in particular heart defects; and 
postnatal effects such as reduced growth, decreased survival, 
developmental neurotoxicity, developmental immunotoxicity, and 
childhood cancers. Some epidemiological studies reported an increased 
incidence of birth defects in TCE[hyphen]exposed populations from 
exposure to contaminated water. As for human developmental 
neurotoxicity, studies collectively suggest that the developing brain 
is susceptible to TCE toxicity. These studies have reported an 
association with TCE exposure and central nervous system birth defects 
and postnatal effects such as delayed newborn reflexes, impaired 
learning or memory, aggressive behavior, hearing impairment, speech 
impairment, encephalopathy, impaired executive and motor function and 
attention deficit disorder (Ref. 2).
    Immune[hyphen]related effects following TCE exposures have been 
observed in adult animal and human studies. In general, these effects 
were associated with enhanced immune response as opposed to 
immunosuppressive effects. Human studies have reported a relationship 
between systemic autoimmune diseases, such as scleroderma, with 
occupational exposure to TCE. There have also been a large number of 
case reports in TCE[hyphen]exposed workers developing a severe 
hypersensitivity skin disorder, often accompanied by systemic effects 
to the lymph nodes and other organs, such as hepatitis (Ref. 2).
    Studies in both humans and animals have shown changes in the 
proximal tubules of the kidney following exposure to TCE (Ref. 2). The 
IRIS TCE assessment concluded that TCE is carcinogenic to humans based 
on convincing evidence of a causal relationship between TCE exposure in 
humans and kidney cancer (Ref. 4). A recent review of TCE by the 
International Agency for Research on Cancer (IARC) also supported this 
conclusion (Ref. 7). The 12th report on carcinogens (RoC) by the 
National Toxicology Program also concluded that TCE is reasonably 
anticipated to be a human carcinogen 2015 (Ref. 8). These additional 
recent peer reviews are consistent with EPA's classification that TCE 
is carcinogenic to humans by all routes of exposures based upon strong 
epidemiological and animal evidence (Refs. 2, 4).
    TCE metabolites appear to be the causative agents that induce renal 
toxicity, including cancer. 
S[hyphen]dichlorovinyl[hyphen]L[hyphen]cysteine (DCVC), and to a lesser 
extent other metabolites, appears to be responsible for kidney damage 
and kidney cancer following TCE exposure. Toxicokinetic data suggest 
that the TCE metabolites derived from glutathione conjugation (in 
particular DCVC) can be systemically delivered or formed in the kidney. 
Moreover, DCVC[hyphen]treated animals showed the same type of kidney 
damage as those treated with TCE (Ref. 2). The toxicokinetic data and 
the genotoxicity of DCVC further suggest that a mutagenic mode of 
action is involved in TCE[hyphen]induced kidney tumors, although 
cytotoxicity followed by compensatory cellular proliferation cannot be 
ruled out. As for the mutagenic mode of action, both genetic 
polymorphisms (Glutathione transferase (GST) pathway) and mutations to 
tumor suppressor genes have been hypothesized as possible mechanistic 
key events in the formation of kidney cancers in humans (Ref. 2).
    The toxicological literature provides support for male and female 
reproductive effects following TCE exposure. Both the epidemiological 
and animal studies provide evidence of adverse effects to female 
reproductive outcomes. However, more extensive evidence exists in 
support of an association between TCE exposures and male reproductive 
toxicity. There is evidence that metabolism of TCE in male reproductive 
tract tissues is associated with adverse effects on sperm measures in 
both humans and animals. Furthermore, human studies support an 
association between TCE exposure and alterations in sperm density and 
quality, as well as changes in sexual drive or function and altered 
serum endocrine levels (Ref. 2).
    Neurotoxicity has been demonstrated in animal and human studies 
under both acute and chronic exposure conditions. Evaluation of 
multiple human studies revealed TCE[hyphen]induced neurotoxic effects 
including alterations in trigeminal nerve and vestibular function, 
auditory effects, changes in vision, alterations in cognitive function, 
changes in psychomotor effects, and neurodevelopmental outcomes. These 
studies in different populations have consistently reported vestibular 
system[hyphen]related symptoms such as headaches, dizziness, and nausea 
following TCE exposure (Ref. 2).
    Animals and humans exposed to TCE consistently experience liver 
toxicity. Specific effects include the following structural changes: 
Increased liver weight, increased DNA synthesis (transient), enlarged 
hepatocytes, enlarged nuclei, and peroxisome proliferation. Several 
human studies

[[Page 7436]]

reported an association between TCE exposure and significant changes in 
serum liver function tests used in diagnosing liver disease, or changes 
in plasma or serum bile acids. There was also human evidence for 
hepatitis accompanying immune[hyphen]related generalized skin diseases, 
jaundice, hepatomegaly, hepatosplenomegaly, and liver failure in 
TCE[hyphen]exposed workers (Ref. 2).
    TCE is characterized as carcinogenic to humans by all routes of 
exposure as documented in EPA's IRIS TCE assessment (Ref. 4). This 
conclusion is based on strong cancer epidemiological data that reported 
an association between TCE exposure and the onset of various cancers, 
primarily in the kidney, liver, and the immune system, i.e., 
non[hyphen]Hodgkin's lymphoma (NHL). Further support for TCE's 
characterization as a carcinogen comes from positive results in 
multiple rodent cancer bioassays in rats and mice of both sexes, 
similar toxicokinetics between rodents and humans, mechanistic data 
supporting a mutagenic mode of action for kidney tumors, and the lack 
of mechanistic data supporting the conclusion that any of the mode(s) 
of action for TCE[hyphen]induced rodent tumors are irrelevant to 
humans. Additional support comes from the 2014 evaluation of TCE's 
carcinogenic effects by IARC, which classifies TCE as carcinogenic to 
humans (Ref. 7). The 12th NTP RoC also concluded that TCE exposure is 
reasonably anticipated to be a human carcinogen (Ref. 8). These 
additional recent peer reviewed documents are consistent with EPA's 
classification that TCE is carcinogenic to humans by all routes of 
exposures based upon strong epidemiological and animal evidence (Refs. 
2, 4).

D. What are the environmental impacts of TCE?

    Pursuant to TSCA section 6(c), this unit describes the effects of 
TCE on the environment and the magnitude of the exposure of the 
environment to TCE. The unreasonable risk determination of this 
proposal is based solely on risks to human health since those risks are 
the most serious consequence of use of TCE and are sufficient to 
support this proposed action. The following is a discussion of the 
environmental impacts of TCE.
    1. Environmental effects and impacts. TCE enters the environment as 
a result of emissions from metal degreasing facilities, and spills or 
accidental releases, and historic waste disposal activities. Because of 
its high vapor pressure and low affinity for organic matter in soil, 
TCE evaporates fairly rapidly when released to soil; however, where it 
is released onto land surface or directly into the subsurface, TCE can 
migrate from soil to groundwater. Based on TCE's moderate persistence, 
low bioaccumulation, and low hazard for aquatic toxicity, the magnitude 
of potential environmental impacts on ecological receptors is judged to 
be low for the environmental releases associated with the use of TCE 
for vapor degreasing. This should not be misinterpreted to mean that 
the fate and transport properties of TCE suggest that water and soil 
contamination is likely low or does not pose an environmental concern. 
EPA is addressing TCE contamination in groundwater, drinking water, and 
contaminated soils at a large number of sites. While the primary 
concern with this contamination has been human health, there is 
potential for TCE exposures to ecological receptors in some cases (Ref. 
2).
    2. What is the global warming potential of TCE? Global warming 
potential (GWP) measures the potency of a greenhouse gas over a 
specific period of time, relative to carbon dioxide, which has a high 
GWP of 1 regardless of the time period used. Due to high variability in 
the atmospheric lifetime of greenhouse gases, the 100-year scale 
(GWP100) is typically used. TCE has relatively low global warming 
potential at a GWP100 of 140 and thus the impact is low (Ref. 2).
    3. What is the ozone depletion potential of TCE? TCE is not an 
ozone-depleting substance and is listed as acceptable under the 
Significant New Alternatives Policy (SNAP) program for degreasing and 
aerosols. In 2007, TCE was identified as a substitute for two ozone 
depleting chemicals, methyl chloroform and CFC-113, for metals, 
electronics, and precision cleaning (72 FR 30142, May 30, 2007) (FRL-
8316-8) (Ref. 9).
    4. Is TCE a volatile organic compound (VOC)? TCE is a VOC as 
defined at 40 CFR 51.100(c). A VOC is any compound of carbon, excluding 
carbon monoxide, carbon dioxide, carbonic acid, metallic carbides or 
carbonates, and ammonium carbonate, which participates in atmospheric 
photochemical reactions.
    5. Does TCE persist in the environment and bioaccumulate? TCE may 
be persistent, but it is not bioaccumulative. TCE is slowly degraded by 
sunlight and reactants when released to the atmosphere. Volatilization 
and microbial biodegradation influence the fate of TCE when released to 
water, sediment or soil. The biodegradation of TCE in the environment 
is dependent on a variety of factors and so a wide range of degradation 
rates have been reported (ranging from days to years). TCE is not 
expected to bioconcentrate in aquatic organisms based on measured 
bioconcentration factors of less than 1000 (Ref. 2).

III. Regulatory Actions Pertaining to TCE

    Because of its potential health effects, TCE is subject to state, 
federal, and international regulations restricting and regulating its 
use, which are summarized in this unit. None of these actions addresses 
the unreasonable risks under TSCA that EPA is seeking to address in 
this proposed rule.

A. Federal Actions Pertaining to TCE

    Since 1979, EPA has issued numerous rules and notices pertaining to 
TCE under its various authorities.
     Toxic Substances Control Act: On December 16, 2016, EPA 
issued a proposed rule under TSCA section 6 to prohibit the manufacture 
(including import), processing, distribution in commerce and commercial 
use of TCE in aerosol degreasers and as a spot removal agent in dry 
cleaning facilities (Ref. 1). In addition, EPA published a final 
Significant New Use Rule (SNUR) that would require manufacturers 
(including importers) and processors of TCE to notify the Agency before 
starting or resuming any significant new uses of TCE in certain 
consumer products, including in spray fixatives used to finish arts and 
crafts (81 FR 20535, April 8, 2016) (Ref. 10).
     Safe Drinking Water Act: EPA has issued drinking water 
standards for TCE pursuant to section 1412 of the Safe Drinking Water 
Act. EPA promulgated the National Primary Drinking Water Regulation 
(NPDWR) for TCE in 1987 (52 FR 25690, July 8, 1987). The NPDWR 
established a non-enforceable maximum contaminant level (MCL) goal of 
zero milligrams per liter (mg/L) based on classification as a probable 
human carcinogen. The NPDWR also established an enforceable MCL of 
0.005 mg/L. EPA is evaluating revising the TCE drinking water standard 
as part of a group of carcinogenic volatile organic compounds.
     Clean Water Act: EPA identified TCE as a toxic pollutant 
under section 307(a)(1) of the Clean Water Act (33 U.S.C. 1317(a)(1)) 
in 1979 (44 FR 44502, July 30, 1979) (FRL-1260-5). In addition, EPA 
developed recommended TCE ambient water quality criteria for the 
protection of human health pursuant to section 304(a) of the Clean 
Water Act.
     Clean Air Act: TCE is a hazardous air pollutant (HAP) 
under the Clean Air Act (42 U.S.C. 7412(b)(1). EPA

[[Page 7437]]

promulgated National Emission Standards for Hazardous Air Pollutants 
(NESHAPs) for TCE for several industrial source categories, including 
halogenated solvent cleaning, fabric printing, coating, and dyeing, and 
synthetic organic chemical manufacturing. The halogenated solvent 
cleaning NESHAP, controls emissions of several halogenated solvents, 
including TCE, from halogenated solvent cleaning machines (40 CFR 
subpart T). The NESHAP includes multiple compliance alternatives to 
allow maximum compliance flexibility. In 2007, EPA promulgated the 
Halogenated Solvent Cleaning NESHAP RTR (Risk and Technology Review) 
Rule (72 FR 25138, May 3, 2007) (FRL-8303-6), in which EPA evaluated 
the health and environmental risks remaining after promulgation of the 
original NESHAP and established revised standards that further limit 
emissions of TCE (and other solvents) in halogenated solvent cleaning. 
Specifically, EPA promulgated a facility-wide emission limit of 60,000 
kilograms per year (kg/year) methylene chloride equivalent, a unit 
which combines emissions of methylene chloride, trichloroethylene, and 
perchloroethylene. The facility-wide emission limit applied to all 
halogenated solvent cleaning machines with the exception of halogenated 
solvent cleaning machines used by the following industries: Facilities 
that manufacture narrow tubing, facilities that use continuous web 
cleaning machines, aerospace manufacturing and maintenance facilities, 
and military maintenance and depot facilities. EPA also promulgated a 
facility-wide emission limit of 100,000 kg/year methylene chloride 
equivalent for halogenated solvent cleaning machines used at military 
maintenance and depot facilities. TCE is also regulated under the 
NESHAP rule for synthetic organic chemical manufacturing. This rule 
consists of four subparts in 40 CFR part 63. In 2003, EPA issued a 
final NESHAP rule to reduce toxic air pollutant emissions from fabric 
and other textile coating, printing, and dyeing facilities. The final 
rule applied to new and existing facilities that emit 10 tons per year 
or more of a single toxic air pollutant listed in the Clean Air Act or 
25 tons per year or more of a combination of those pollutants, 
including TCE. In addition, EPA has established VOC standards for 
consumer products under section 183(e) of the Clean Air Act.
     Resource Conservation and Recovery Act (RCRA): EPA 
classifies certain wastes containing TCE as hazardous waste subject to 
Subtitle C of RCRA pursuant to the toxicity characteristics or as a 
listed waste. RCRA also provides authority to require cleanup of 
hazardous wastes containing TCE at RCRA facilities.
     Comprehensive Environmental Response, Compensation and 
Liability Act (CERCLA): EPA designated TCE as a hazardous substance 
with a reportable quantity pursuant to section 102(a) of CERCLA and EPA 
is actively overseeing cleanup of sites contaminated with TCE pursuant 
to the National Contingency Plan (NCP). While many of the statutes that 
EPA is charged with administering provide statutory authority to 
address specific sources and routes of TCE exposure, none of these can 
address the serious human health risks from TCE exposure that EPA is 
proposing to address under TSCA section 6(a) with this proposed rule.
    The Occupational Safety and Health Administration (OSHA) 
established a permissible exposure limit (PEL) for TCE in 1971. The PEL 
is an 8-hour time-weighted average (TWA) TCE concentration of 100 ppm. 
In addition, the TCE PEL requires that exposure to TCE not exceed 200 
ppm (ceiling) at any time during an eight hour work shift with the 
following exception: Exposures may exceed 200 ppm, but not more than 
300 ppm (peak), for a single time period up to 5 minutes in any 2 hours 
(Ref. 11). OSHA acknowledges that many of its PELs are not sufficiently 
protective of worker health. OSHA has noted that ``with few exceptions, 
OSHA's PELs, which specify the amount of a particular chemical 
substance allowed in workplace air, have not been updated since they 
were established in 1971 under expedited procedures available in the 
short period after the OSH Act's adoption . . . Yet, in many instances, 
scientific evidence has accumulated suggesting that the current limits 
are not sufficiently protective'' (Ref. 12 at p. 61386), including the 
PEL for TCE.
    To provide employers, workers, and other interested parties with a 
list of alternate occupational exposure limits that may serve to better 
protect workers, OSHA's Web page highlights selected occupational 
exposure limits derived by other organizations. For example, the 
National Institute for Occupational Safety and Health considers TCE a 
potential occupational carcinogen and recommended an exposure limit of 
25 ppm as a 10-hour TWA in 2003 (Ref. 13). The American Conference of 
Governmental Industrial Hygienists recommended an 8-hour TWA of 10 ppm 
and an acute, or short term, exposure limit of 25 ppm in 2004 (Ref. 
14).

B. State Actions Pertaining to TCE

    Many states have taken actions to reduce risks from TCE use. TCE is 
listed on California's Safer Consumer Products regulations candidate 
list of chemicals that exhibit a hazard trait and are on an 
authoritative list and is also listed on California's Proposition 65 
list of chemicals known to cause cancer or birth defects or other 
reproductive harm. In addition, the California Code of Regulations, 
Title 17, Section 94509(a) lists standards for VOCs for consumer 
products sold, supplied, offered for sale, or manufactured for use in 
California (Ref. 15). As part of that regulation, use of consumer 
general purpose degreaser products that contain TCE are banned in 
California and safer substitutes are in use.
    In Massachusetts, TCE is a designated high hazard substance, with 
an annual reporting threshold of 1,000 pounds (Ref. 16). Minnesota 
classifies TCE as a chemical of high concern (Ref. 17). Many other 
states have considered TCE for similar chemical listings (Ref. 18). 
Several additional states have various TCE regulations that range from 
reporting requirements to product contamination limits to use reduction 
efforts aimed at limiting or prohibiting TCE content in products.
    Most states have set PELs identical to the OSHA 100 ppm 8-hour TWA 
PEL (Ref. 18). Nine states have PELs of 50 ppm (Ref. 18). California's 
PEL of 25 ppm is the most stringent (Ref. 15). All of these PELs are 
significantly higher than the exposure levels at which EPA identified 
unreasonable risks for TCE use for vapor degreasing and would not be 
protective.

C. International Actions Pertaining to TCE

    TCE is also regulated internationally and the international 
industrial and commercial sectors have moved to alternatives. TCE was 
added to the EU Registration, Evaluation, Authorisation and Restriction 
of Chemicals (REACH) restriction of substances classified as a 
carcinogen category 1B under the EU Classification and Labeling 
regulation in 2009 (Ref. 19). The restriction prohibits the placing on 
the market or use of TCE as a substance, as a constituent of other 
substances, or in mixtures for supply to the general public when the 
individual concentration of TCE in the substance or mixture is equal to 
or greater than 0.1% by weight (Ref. 19). In 2010, TCE was added to the 
Candidate List of substances for inclusion in Annex XIV of REACH, or 
the Authorisation List. Annex XIV includes substances of very high 
concern that are subject to use

[[Page 7438]]

authorization due to their hazardous properties. TCE meets the criteria 
for classification as a carcinogen. In 2011, TCE was recommended for 
inclusion in Annex XIV of REACH due to the very high volumes allocated 
to uses in the scope of authorization and because at least some of the 
described uses appeared to result in significant exposure of workers 
and professionals, and could be considered widely dispersive uses.
    In 2013, the Commission added TCE to Annex XIV of REACH, making it 
subject to authorization. As such, entities that wanted to use TCE were 
required to apply for authorization by October 2014, and those entities 
without an authorization were required to stop using TCE by April 2016. 
The European Chemicals Agency (ECHA) received 19 applications for 
authorization from entities interested in using TCE beyond April 2016. 
Two of those were for vapor degreasing applications (Refs. 20, 21). In 
each case, the opinion of the Committee for Risk Assessment was that it 
was not possible to determine a derived no-effect level (DNEL) for the 
carcinogenicity properties of the substance in accordance with REACH 
and that the operational conditions and risk management measures in the 
applications appeared not to limit the risk. Those measures included 
use in a specific type of closed vapor degreasing system with personal 
protective equipment (PPE). Final decisions have not yet been made on 
the applications.
    Canada conducted a hazard assessment of TCE in 1993 and concluded 
that ``trichloroethylene occurs at concentrations that may be harmful 
to the environment, and that may constitute a danger in Canada to human 
life or health. It has been concluded that trichloroethylene occurs at 
concentrations that do not constitute a danger to the environment on 
which human life depends'' (Ref. 22). In 2003, Canada issued the 
Solvent Degreasing Regulations (SOR/2003-283) to reduce releases of TCE 
into the environment from solvent degreasing facilities using more than 
1,000 kilograms of TCE per year (Ref. 23). In 2013, Canada added TCE to 
the Toxic Substances List--Schedule 1 because TCE ``is entering or may 
enter the environment in a quantity or concentration or under 
conditions that: (a) Have or may have an immediate or chronic harmful 
effect on the environment or its biological diversity, and (c) 
constitute or may constitute a danger in Canada to human life or 
health.'' (Ref. 23).
    In Japan, the Chemical Substances Control Law considers TCE a Class 
II substance (substances that may pose a risk of long[hyphen]term 
toxicity to humans or to flora and fauna in the human living 
environment, and that have been, or in the near future are reasonably 
likely to be, found in considerable amounts over a substantially 
extensive area of the environment) (Ref. 24). Japan also controls air 
emissions and water discharges containing TCE, as well as aerosol 
products for household use and household cleaners containing TCE.
    TCE is listed in the Australian National Pollutant Inventory, a 
program run cooperatively by the Australian, State and Territory 
governments to monitor common pollutants and their levels of release to 
the environment. Australia classifies TCE as a health, physicochemical 
and/or ecotoxicological hazard, according to the Australian National 
Occupational Health and Safety Commission (Ref. 25).

IV. TCE Risk Assessment

    In 2013, EPA identified TCE use as a solvent degreaser (aerosol 
degreasing and vapor degreasing) and spot remover in dry cleaning 
operations as a priority for risk assessment under the TSCA Work Plan. 
This Unit describes the development of the TCE risk assessment and 
supporting analysis and expert input on vapor degreasing, the use that 
is the subject of this proposed rule. A more detailed discussion of the 
risks associated with TCE use in vapor degreasing can be found in Unit 
VI.

A. TSCA Work Plan for Chemical Assessments

    In 2012, EPA released the TSCA Work Plan Chemicals: Methods 
Document in which EPA described the process the Agency intended to use 
to identify potential candidate chemicals for near-term review and 
assessment under TSCA (Ref. 26). EPA also released the initial list of 
TSCA Work Plan chemicals identified for further assessment under TSCA 
as part of its chemical safety program (Ref. 27).
    The process for identifying these chemicals for further assessment 
under TSCA was based on a combination of hazard, exposure, and 
persistence and bioaccumulation characteristics, and is described in 
the TSCA Work Plan Chemicals Methods Document (Ref. 26). Using the TSCA 
Work Plan chemical prioritization criteria, TCE ranked high for health 
hazards and exposure potential and was included on the initial list of 
TSCA Work Plan chemicals for assessment.

B. TCE Risk Assessment

    EPA finalized a TSCA Work Plan Chemical Risk Assessment for TCE 
(TCE risk assessment) in June 2014, following the July 2013 peer review 
of the December 2012 draft TCE risk assessment. All documents from the 
July 2013 peer review of the draft TCE risk assessment are available in 
EPA Docket Number EPA-HQ-OPPT-2012-0723. TCE appears in the 2014 update 
of the TSCA Work Plan for Chemical Assessments and the completed risk 
assessment is noted therein. The TCE risk assessment evaluated 
commercial and consumer use of TCE as a solvent degreaser (aerosol 
degreasing and vapor degreasing), commercial use of TCE as a spotting 
agent at dry cleaning facilities, and consumer use of TCE as a spray-
applied protective coating for arts and crafts (Ref. 2).
    The uses selected for the TCE risk assessment were chosen because 
they were expected to involve frequent or routine use of TCE in high 
concentrations and/or have high potential for human exposure (Ref. 2). 
However, this does not mean that EPA found that other uses not included 
in the TCE risk assessment present low risk.
    As described in the TCE risk assessment, solvent cleaning or 
degreasing is widely used to remove grease, oils, waxes, carbon 
deposits, fluxes, and tars from metal, glass, or plastic surfaces. With 
respect to vapor degreasing, there are two general types of degreasing 
machines: Batch and in[hyphen]line. Batch cleaning machines are the 
most common type, while in[hyphen]line cleaners are typically used in 
large[hyphen]scale industrial operations. There are a number of 
variations of each general type of machine. Emissions from degreasing 
machines typically result from:
     Evaporation of the solvent from the interface between the 
solvent and the air,
     ``Carry out'' of excess solvent on cleaned parts, and
     Evaporative losses of the solvent during filling and 
draining of the degreasing machine.
    In its assessment of vapor degreasing, the TCE risk assessment 
concentrated on open top vapor degreasing machines because they are the 
most prevalent, particularly for smaller operations. The risk 
assessment identified acute and chronic non[hyphen]cancer risks for 
workers who conduct TCE[hyphen]based solvent vapor degreasing at small 
degreasing facilities, as well as occupational bystanders to those 
activities. More specifically, the TCE risk assessment identified risks 
for non-cancer developmental effects resulting from acute exposure. The 
risk assessment also identified risks for a range of non-cancer health 
effects resulting from chronic exposure. Within

[[Page 7439]]

this range of effects, the greatest risk is for developmental effects 
(i.e., fetal cardiac defects), although there also are risks for kidney 
effects and immunotoxicity. In addition, there are risks for adverse 
reproductive effects, neurotoxicity, and liver toxicity associated with 
chronic exposures (Ref. 2).
    Margins of exposure (MOEs) were used in this assessment to estimate 
non-cancer risks for acute and chronic exposures. The MOE is the health 
point of departure (an approximation of the no-observed adverse effect 
level) for a specific endpoint divided by the exposure concentration 
for the specific scenario of concern. The benchmark MOE accounts for 
the total uncertainty factor based on the following uncertainty 
factors: Intraspecies, interspecies, subchronic to chronic, and lowest 
observed adverse effect level (LOAEL) to no-observed adverse effect 
level (NOAEL). Uncertainty factors are intended to account for (1) the 
variation in sensitivity among the members of the human population 
(i.e., interhuman or intraspecies variability); (2) the uncertainty in 
extrapolating animal data to humans (i.e., interspecies variability); 
(3) the uncertainty in extrapolating from data obtained in a study with 
less-than-lifetime exposure to lifetime exposure (i.e., extrapolating 
from subchronic to chronic exposure); and (4) the uncertainty in 
extrapolating from a LOAEL rather than from a NOAEL (Ref. 28). MOEs 
provide a non-cancer risk profile by presenting a range of estimates 
for different non-cancer health effects for different exposure 
scenarios, and are a widely recognized method for evaluating a range of 
potential non-cancer health risks from exposure to a chemical.
    The acute inhalation risk assessment used developmental toxicity 
data to evaluate the acute risks for the TCE use scenarios. As 
indicated in the TCE risk assessment, EPA's policy supports the use of 
developmental studies to evaluate the risks of acute exposures. This 
science-based policy presumes that a single exposure of a chemical at a 
critical window of fetal development may produce adverse developmental 
effects (Ref. 5). This is the case with cardiac malformation. EPA 
reviewed multiple studies for suitability for acute risk estimation 
including a number of developmental studies of TCE exposure and 
additional developmental studies of TCE metabolites (Appendix N) (Ref. 
2). EPA based its acute risk assessment on the most sensitive health 
endpoint (i.e., fetal heart malformations) representing the most 
sensitive human life stage (i.e., the developing fetus) (Ref. 2). The 
acute risk assessment used the physiologically-based pharmacokinetic 
(PBPK)[hyphen]derived hazard values (HEC50, HEC95, or HEC99; HECXX is 
the Human Equivalent Concentration at a particular percentile) from the 
Johnson et al. (2003) (Ref. 29) developmental toxicity study for each 
vapor degreaser use scenario. Note that the differences among these 
hazard values is small and no greater than 3[hyphen]fold (i.e., 
2[hyphen]fold for HEC50/HEC95 ratios; 3[hyphen]fold for HEC50/HEC99 
ratios; 1.4[hyphen]fold for HEC95/HEC99 ratios). The IRIS TCE 
assessment used the HEC99 for the non[hyphen]cancer 
dose[hyphen]response derivations because the HEC99 was interpreted to 
be protective for a sensitive individual in the population (Ref. 4). 
While the HEC99 was used to find the level of risk to be used in making 
the proposed TSCA section 6(a) determination, the small variation among 
HEC50, HEC95 and HEC99 would not result in a different risk 
determination.
    For non-cancer effects, EPA estimated exposures that are 
significantly greater than the point of departure. The baseline cancer 
risk is estimated to be 3.66 x 10-1 for users of open top 
vapor degreasing systems.
    The levels of acute and chronic exposures estimated to present low 
risk for non-cancer effects also result in low risk for cancer.
    Given these identified risks, EPA conducted an additional analysis 
consistent with the scope of the TCE risk assessment to better 
characterize the risk to workers and occupational bystanders from the 
use of TCE in batch vapor degreasing machines as well as in two 
different types of in-line systems (conveyor and continuous web 
cleaning machines) (Ref. 30). This analysis also evaluated the exposure 
reductions that would result from switching from an open-top vapor 
degreasing system to a closed-loop vapor degreasing system. More 
information on the different types of vapor degreasing machines can be 
found in Unit VI.A.1. In the supplemental analysis, EPA identified 
short-term and long-term non-cancer and cancer risks for all types of 
vapor degreasing machines, although the risks for closed-loop machines 
are estimated to be lower than for any of the other types (Ref. 30).

C. Stakeholder Input on TCE and Vapor Degreasing

    On July 29, 2014, EPA held a 2-day public workshop on TCE 
degreasing (Ref. 31). The purpose of the workshop was to collect 
information from users, academics, and other stakeholders on the use of 
TCE as a degreaser in various applications, e.g., in degreasing metal 
parts, availability and efficacy of safer alternatives, safer 
engineering practices and technologies to reduce exposure to TCE, and 
to discuss possible risk reduction approaches. The workshop included 
presentations by experts, breakout sessions with case studies, and 
public comment opportunities (Ref. 31) and informed EPA's assessment of 
the alternatives to TCE considered in this proposed rule. All documents 
from the public workshop are available in EPA Docket Number EPA-HQ-
OPPT-2014-0327. Informed in part by the workshop and other analysis, 
including discussion with the Toxics Use Reduction Institute at the 
University of Massachusetts Lowell, EPA has concluded that TCE 
alternatives are available for all applications subject to this 
proposed rule as well as EPA's earlier proposal (Ref. 1). The 
discussions at the public workshop demonstrated that alternatives are 
available for the vapor degreasing uses that are being addressed in 
this proposed rulemaking.
    On June 1, 2016, EPA convened a Small Business Advocacy Review 
(SBAR) Panel on TCE in vapor degreasing. The Panel solicited input from 
eighteen Small Entity Representatives (SERs) and made several 
recommendations on aspects of this rulemaking. The Panel process, 
including the final report of the Panel (Ref. 32), is discussed in Unit 
XII.

V. Regulatory Approach

A. TSCA Section 6 Unreasonable Risk Analysis

    Under TSCA section 6(a), if the Administrator determines that a 
chemical substance presents an unreasonable risk of injury to health or 
the environment, without consideration of costs or other non-risk 
factors, including an unreasonable risk to a potentially exposed or 
susceptible subpopulation identified as relevant to the Agency's risk 
evaluation, under the conditions of use, EPA must by rule apply one or 
more requirements to the extent necessary so that the chemical 
substance no longer presents such risk.
    The TSCA section 6(a) requirements can include one or more, or a 
combination of, the following actions:
     Prohibit or otherwise restrict the manufacturing, 
processing, or distribution in commerce of such substances (Sec.  
6(a)(1)).
     Prohibit or otherwise restrict manufacturing, processing, 
or distribution in commerce of such substances for particular uses or 
for uses in excess of a specified concentration (Sec.  6(a)(2)).

[[Page 7440]]

     Require minimum warning labels and instructions (Sec.  
6(a)(3)).
     Require record keeping or testing (Sec.  6(a)(4)).
     Prohibit or regulate any manner or method of commercial 
use (Sec.  6(a)(5)).
     Prohibit or otherwise regulate any manner or method of 
disposal (Sec.  6(a)(6)).
     Direct manufacturers and processors to give notice of the 
determination to distributors and the public and replace or repurchase 
substances (Sec.  6(a)(7)).
    EPA analyzed a wide range of regulatory options under TSCA section 
6(a) in order to select the proposed regulatory approach. EPA 
considered whether a regulatory option (or combination of options) 
would address the identified unreasonable risks so that the chemical 
substance no longer presents such risks. To do so, EPA initially 
analyzed whether the regulatory options could reduce risks (non-cancer 
and cancer) to levels below those of concern, based on EPA's technical 
analysis of exposure scenarios. For the non-cancer risks, EPA found an 
option could be protective against the risk if it could achieve the 
benchmark MOE for the most sensitive non-cancer endpoint. EPA's 
assessments for these uses indicate that when exposures meet the 
benchmark MOE for the most sensitive endpoint, they also result in low 
risk for cancer.
    After the technical analysis, which represents EPA's assessment of 
the potential for the regulatory options to achieve risk benchmarks 
based on analysis of exposure scenarios, EPA then considered how 
reliably the regulatory options would actually reach these benchmarks. 
For the purposes of this proposal, EPA found that an option addressed 
the risk so that it was no longer unreasonable if the option could 
achieve the benchmark MOE or cancer benchmark for the most sensitive 
endpoint. In evaluating whether a regulatory option would ensure that 
the chemical substance no longer presents the identified unreasonable 
risks, the Agency considered whether the option could be realistically 
implemented or whether there were practical limitations on how well the 
option would mitigate the risks in relation to the benchmarks, as well 
as whether the option's protectiveness was impacted by environmental 
justice or children's health concerns.

B. TSCA Section 6(c)(2) Considerations

    TSCA section 6(c)(2) requires EPA to consider and publish a 
statement based on reasonably available information with respect to 
the:
     Health effects of the chemical substance or mixture (in 
this case, TCE) 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;
     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 and benefits of the proposed and final rule and of 
the one or more primary alternatives that EPA considered; and the cost 
effectiveness of the proposed rule and of the one or more primary 
alternatives that EPA considered.
    In addition, in selecting among prohibitions and other restrictions 
available under TSCA section 6(a), EPA must factor in, to the extent 
practicable, these considerations. Further, in deciding whether to 
prohibit or restrict in a manner that substantially prevents a specific 
condition of use of a chemical substance or mixture, and in setting an 
appropriate transition period for such action, EPA must also consider, 
to the extent practicable, whether technically and economically 
feasible alternatives that benefit health or the environment will be 
reasonably available as a substitute when the proposed prohibition or 
other restriction takes effect.
    EPA's analysis of the health effects of and magnitude of exposure 
to TCE can be found in Units IV and VI, which discuss the TCE risk 
assessment and EPA's regulatory assessment of the use of TCE in vapor 
degreasing. A discussion of the environmental effects of TCE can be 
found in Unit II.D.
    With respect to the costs and benefits of this proposal and the 
alternatives EPA considered, as well as the impacts on small 
businesses, the full analysis is presented in the economic analysis 
document (Ref. 3) To the extent information was available, EPA 
considered the benefits realized from risk reductions (including 
monetized benefits, non-monetized quantified benefits, and qualitative 
benefits), offsets to benefits from countervailing risks (e.g., risks 
from chemical substitutions and alternative practices), the relative 
risk for environmental justice populations and children and other 
potentially exposed or susceptible subpopulations (as compared to the 
general population), and the cost of regulatory requirements for the 
various options. A discussion of the benefits EPA considered can be 
found in Units VI.C. and VII.
    EPA considered the estimated costs to regulated entities as well as 
the cost to administer and enforce the options. For example, an option 
that includes use of a respirator would include inspections to evaluate 
compliance with all elements of a respiratory protection program. EPA 
took into account reasonably available information about the 
functionality and performance efficacy of the regulatory options and 
the ability to implement the use of chemical substitutes or other 
alternatives (e.g., PPE). Reasonably available information included the 
existence of other Federal, state, or international regulatory 
requirements associated with each of the regulatory options as well as 
the commercial history for the options. A discussion of the costs EPA 
considered can be found in Units VI.E. and VII, along with a discussion 
of the cost effectiveness of the proposal and the alternatives that EPA 
considered. In addition, a discussion of the impacts on small 
businesses can be found in Unit XII.C.
    With respect to the anticipated effects of this proposal on the 
national economy, EPA considered the number of businesses and workers 
that would be affected and the costs and benefits to those businesses 
and workers. In addition, EPA considered the employment impacts of this 
proposal, as discussed in the economic analysis for this proposal (Ref. 
3). EPA found that the direction of change in employment is uncertain, 
but the expected short term and longer term employment effects are 
expected to be small.
    The benefits of TCE in vapor degreasing are discussed in Unit 
VI.D., along with the availability of alternatives. The dates that the 
proposed restrictions would take effect are discussed in Unit X.D., as 
is the availability of alternatives to TCE vapor degreasing on those 
dates.
    Finally, with respect to this proposal's effect on technological 
innovation, EPA expects this action to spur innovation, not hinder it. 
(Ref. 3) An impending ban on the use of TCE in vapor degreasing is 
likely to increase demand for alternatives, which would be expected to 
result in the development of new alternatives.

C. Regulatory Options Receiving Limited Evaluation

    As discussed previously, EPA analyzed a wide range of regulatory 
options under TSCA section 6(a). One of the options EPA evaluated 
involved a TSCA section 6(a)(3) requirement for warning labels or 
instructions on containers of TCE or on vapor degreasing equipment. 
However, EPA

[[Page 7441]]

reasoned that warning labels and instructions alone could not mitigate 
the identified unreasonable risks presented by TCE to workers operating 
vapor degreasing equipment. In making this finding, EPA considered 
several factors including the fact that, in many cases, the workers 
being exposed are not in a position to influence their employer's 
decisions about the type of solvent or the type of degreasing equipment 
that will be used, or ensure that their employer provides appropriate 
PPE and an adequate respiratory protection program. EPA also considered 
the analysis of relevant studies that was discussed in the prior 
proposal on TCE (Ref. 33). This analysis found that even professional 
users do not consistently pay attention to labels; they often do not 
understand label information; and they often base a decision to follow 
label information on previous experience and perceptions of risk (Ref. 
33).
    EPA found that presenting information about TCE on a label would 
not adequately address the identified unreasonable risks because the 
nature of the information the user or owner would need to read, 
understand, act upon, convey, and ensure adherence to is extremely 
complex. It would be challenging to most users or owners to follow or 
convey the complex product label instructions required to explain how 
to reduce exposures to the extremely low levels needed to minimize the 
risk from TCE. Rather than a simple message, the label would need to 
explain a variety of inter-related factors, including but not limited 
to the use of local exhaust ventilation, respirators and assigned 
protection factor for the user and bystanders, and time periods during 
pregnancy with susceptibility of the developing fetus to acute 
developmental effects, as well as effects to bystanders. It is unlikely 
that label language changes for this use will result in widespread, 
consistent, and successful adoption of risk reduction measures by users 
and owners.
    While labeling alone would not address the identified unreasonable 
risks so that TCE used in vapor degreasing no longer presents such 
risks, EPA recognizes that the TSCA section 6(a)(3) warnings and 
instruction requirement can be an important component of an approach 
that addresses identified unreasonable risks with a specific use 
prohibition. EPA has included a simple downstream notification 
requirement as part of this proposed rule to ensure that users would be 
made aware of the ban on the use of TCE in vapor degreasing.
    In addition, early in the process, EPA identified two regulatory 
options under TSCA section 6(a) that do not pertain to this action and 
were therefore not evaluated for this proposed rulemaking. First, EPA 
reasoned that the TSCA section 6(a)(1) regulatory option to prohibit 
the manufacture (including import), processing or distribution in 
commerce of TCE or limit the amount of TCE which may be manufactured 
(including imports), processed or distributed in commerce is not 
germane because the Agency is not proposing to ban or limit the 
manufacture (including import), processing or distribution in commerce 
of TCE for uses other than in vapor degreasing, aerosol degreasing or 
for spot cleaning in dry cleaning facilities at this time. In addition, 
EPA reasoned that the TSCA section 6(a)(6) regulatory option to 
prohibit or otherwise regulate any manner or method of disposal of the 
chemical is not applicable since EPA did not evaluate the risks 
associated with ongoing TCE disposal.

VI. Regulatory Assessment of TCE Use in Vapor Degreasing

    This Unit describes the current use of TCE in vapor degreasing, the 
unreasonable risks presented by this use, and how EPA identified which 
regulatory options address those unreasonable risks so that TCE in 
vapor degreasing no longer presents such unreasonable risks.

A. Description of the Current Use

    Vapor degreasing is a cleaning process that uses a solvent vapor to 
remove contaminants such as grease, oils, dust, and dirt from 
fabricated parts. Solvents such as TCE are boiled in a degreasing unit 
to produce a hot vapor. When parts are placed into the degreaser, the 
hot vapor within the unit condenses onto the parts, causing beading and 
dripping. The dripping action carries the contaminants away from the 
fabricated part, leaving behind a clean surface. After vapor 
degreasing, the parts are suspended on a rack in order to drain the 
solvent (Ref. 30). Vapor degreasing is used in a variety of 
occupational settings such as metal plating, electronics assembly, 
metal or composite part fabrication, and repair shops.
    Vapor degreasing may take place in batches or as part of an in-line 
(i.e., continuous) system. In batch machines, each load (parts or 
baskets of parts) is loaded into the machine after the previous load is 
completed. With in-line systems, parts are continuously loaded into and 
through the vapor degreasing equipment as well as the subsequent drying 
steps.
    The five basic types of batch vapor degreasers are described in the 
following paragraphs (Ref. 30):
    As the name suggests, open-top vapor degreasers are open at the top 
to allow introduction of the parts to be cleaned. Heating elements at 
the bottom of the cleaner heat the liquid solvent to above its boiling 
point. Solvent vapor rises in the machine to the height of chilled 
condensing coils on the inside walls of the cleaner. The condensing 
coils cool the vapor, causing it to condense and return to the bottom 
of the cleaner. Cleaning occurs in the vapor zone above the liquid 
solvent and below the condensing coils, as the hot vapor solvent 
condenses on the cooler work surface. The workload or a parts basket is 
lowered into the heated vapor zone with a mechanical hoist. While the 
condensing coils reduce the amount of solvent that escapes the vapor 
zone, they do not eliminate emissions, and throughout the degreasing 
process, significant vapor emissions of the solvent can occur. These 
vapor emissions are hazardous to workers operating the machine, as well 
as nearby workers. In addition, replacing solvent lost to emissions can 
be costly. In assessing the use of TCE in vapor degreasers, the TCE 
risk assessment focused on the use of open top vapor degreasing 
systems.
    Vapor emissions of solvent can be reduced by enclosing the vapor 
degreasing machine. Open top vapor degreasing systems with enclosures 
operate in the same manner as standard open top vapor degreasing 
systems, except that the machine is enclosed on all sides during 
degreasing. The enclosure is opened and closed when adding or removing 
parts, and solvent is exposed to the air when the cover is open. Nearly 
all open top vapor degreasing systems regulated by the NESHAP have a 
cover because that is a more common compliance strategy than complying 
with the overall emission limit. A variety of additional controls may 
be needed to comply with the NESHAP, including two-part covers, 
extended freeboard (the area above the vapor zone), freeboard 
refrigeration devices, and holding cleaned parts in the freeboard to 
allow draining. Enclosed vapor degreasing systems may be vented 
directly to the atmosphere or first vented to an external carbon filter 
and then to the atmosphere.
    Solvent emissions can be further reduced by using a sealed, closed-
loop degreasing system. In airtight closed-loop systems, parts are 
placed into a basket, which is then placed into an airtight work 
chamber. The door is closed and solvent vapors are sprayed

[[Page 7442]]

onto the parts. When cleaning is complete, vapors are exhausted from 
the work chamber and circulated over a cooling coil to condense and 
recover the solvent. The parts are dried by forced hot air. Air is 
circulated through the chamber and residual solvent vapors are captured 
by carbon adsorption. The door is opened when the residual solvent 
vapor concentration has reached a specified level.
    A refinement of the airtight closed-loop degreasing system is the 
airless degreasing system. An airless system removes air at some point 
during the degreasing process. Typically, this takes the form of 
drawing vacuum, but some machines purge the air with nitrogen. In 
airless degreasing systems with vacuum drying, a vacuum is generated, 
typically below 5 torr, which dries the parts. A vapor recovery system 
recovers the solvent.
    The greatest solvent emission reductions are achieved with the 
airless vacuum-to-vacuum degreasing system. These systems are referred 
to as airless because the entire cycle is operated under vacuum. 
Typically, parts are placed into the chamber, the chamber sealed, and 
then vacuum drawn within the chamber. The parts are then sprayed with 
hot solvent vapor, which raises the pressure in the chamber. The parts 
are dried by again drawing vacuum in the chamber. Solvent vapors are 
recovered through compression and cooling. An air purge then removes 
residual vapors which can be routed to an optional carbon adsorber and 
then out a vent. Finally, air is introduced to return the chamber to 
atmospheric pressure so that the chamber can be opened. These systems 
have the added benefit of generating vapor at a much lower temperature 
than open-top degreasing systems because the boiling point of TCE is 
lower at the lower pressure of these systems.
    In contrast to batch degreasers, in-line vapor degreasing systems 
use an automated parts handling system, often a conveyor, to 
automatically provide a continuous supply of parts to be cleaned (Ref. 
30). Conveyorized vapor degreasing systems are usually fully enclosed 
except for the conveyor inlet and outlet portals. Conveyorized 
degreasers are likely used in the same applications as batch vapor 
degreasers, except that they would be used in larger operations, where 
the number of parts being cleaned is large enough to warrant the use of 
a conveyorized system. Conveyorized degreasers use different methods 
for transporting the parts through the cleaning zone. For example, 
monorail degreasers use a straight-line conveyor to transport parts 
into and out of the cleaning zone; these systems are typically used 
when parts are already being transported through manufacturing areas by 
a conveyor. Cross-rod degreasers use two parallel chains connected by a 
rod to support the parts, which are typically loaded manually into 
perforated baskets or cylinders. Ferris wheel degreasing systems, 
generally the smallest of the conveyorized degreasers, rotate manually-
loaded baskets or cylinders of parts vertically through the cleaning 
zone and back out. Belt degreasers are used for simple and rapid 
loading and unloading of parts; the parts are loaded onto a mesh 
conveyor belt that transports them through the cleaning zone and out 
the other side.
    There are also continuous web cleaning machines (Ref. 30). These 
in-line degreasers differ from typical conveyorized degreasers in that 
they are specifically designed for cleaning parts that are coiled or on 
spools such as films, wires, metal strips, and metal sheets. In 
continuous web degreasers, parts are uncoiled and loaded onto rollers 
that transport the parts through the cleaning and drying zones at 
speeds typically greater than 11 feet per minute. The parts are then 
recoiled or cut after exiting the machine.

B. Analysis of Regulatory Options

    In this unit, EPA explains how it evaluated whether the regulatory 
options considered would address the unreasonable risks presented by 
the current use so that TCE in vapor degreasing no longer presents such 
unreasonable risks. First, EPA characterizes the unreasonable risks 
associated with the current use of TCE in vapor degreasers. Then, the 
Agency describes its initial analysis of which regulatory options have 
the potential to reach the protective non-cancer and cancer benchmarks. 
The levels of acute and chronic exposures estimated to present low risk 
for non-cancer effects also result in low risk for cancer. Lastly, this 
unit evaluates how well those regulatory options would address the 
identified unreasonable risks in practice.
    1. Risks associated with the current use. a. General impacts. The 
TCE risk assessment identified cancer and non[hyphen]cancer risks from 
acute and chronic exposure for workers operating vapor degreasers and 
for occupational bystanders, nearby workers who have the potential to 
be exposed to TCE but are not directly involved with degreasing 
operations (Ref. 2). Because the TCE risk assessment focused on open 
top vapor degreasing systems, EPA performed supplemental analysis 
consistent with the methodology used in the risk assessment for closed-
loop, conveyorized, and continuous web degreasers and identified cancer 
and non[hyphen]cancer risks from acute and chronic exposure for each of 
the scenarios (Ref. 30). EPA estimates that there are approximately 
2,600 to 6,000 open top vapor degreasing systems currently using TCE, 
120 closed-loop systems currently using TCE, and 150 in-line (either 
conveyorized or continuous web) systems currently using TCE, with an 
estimated 17 workers and occupational bystanders per machine (Ref. 3). 
This means that there are an estimated 40,800 to 102,000 persons 
exposed to TCE from open top vapor degreasing systems, 2,040 persons 
exposed to TCE from closed-loop systems, and 2,550 persons exposed to 
TCE from in-line systems.
    b. Impacts on minority and low income populations. There is no 
known disproportionate representation of minority or low income 
populations in these occupations.
    c. Impacts on children. EPA has concerns for effects on the 
developing fetus from acute and chronic worker and occupational 
bystander exposures to TCE used in vapor degreasers. The risk estimates 
are focused on pregnant women because one of the most sensitive health 
effects associated with TCE exposure from vapor degreasing is adverse 
effects on the developing fetus. The potential risk due to exposure 
during pregnancy is significant. 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. 34). More 
specifically, in this case, a woman who is not planning a pregnancy may 
not take steps to avoid exposure to TCE in vapor degreasing. EPA 
estimates that there are over 1,000 pregnant women exposed to TCE as a 
result of vapor degreasers.
    d. Specific vapor degreaser exposure information. In the 
supplemental analysis (Ref. 30), EPA estimated baseline exposures for 
all batch vapor degreasing machines, regardless of facility size, and 
for in-line vapor degreasing machines (both conveyorized and continuous 
web). Baseline exposures for in-line machines were not specifically 
calculated in the TCE risk assessment. For the supplemental analysis, 
estimating the baseline exposures involved using a near-field/far-field 
modeling approach to estimate airborne concentrations of TCE and Monte 
Carlo simulation to establish the range and likelihood of exposures. 
The near-field/far-field model estimates airborne concentrations in a 
near field (a

[[Page 7443]]

zone close to the source of exposure) and a far field (a zone farther 
from the source of exposure but within the occupational building). 
Controls required by the 2007 NESHAP were accounted for in the 
estimations. (Ref. 30) EPA used these estimated airborne concentrations 
to estimate 8-hour time weighted average (TWA) exposures for workers 
(i.e., in the near field) and occupational bystanders (i.e., in the far 
field). Details of the modeling and estimation method for calculating 
exposure levels during vapor degreasing are available in the 
supplemental analysis document (Ref. 30). This analysis is based on the 
methodology used in the peer reviewed TCE risk assessment (Ref. 2). 
Prior to promulgation of the final rule, EPA will peer review the 
``supplemental Occupational Exposure and Risk Reduction Technical 
Report in Support of Risk Management Options for Trichloroethylene 
(TCE) Use in Vapor Degreasing'' (Ref. 30).
    The estimated 8-hour TWA exposure levels for open top vapor 
degreasing systems ranged from 2.74 ppm to 491.36 ppm for workers, with 
the 50th percentile at 55.16 ppm and the 99th percentile at 190.17 ppm. 
For occupational bystanders, the exposure levels ranged from 0.33 ppm 
to 440.61 ppm, with the 50th percentile at 20.45 ppm and the 99th 
percentile at 144.93 ppm. The estimated 8-hour TWA exposure levels for 
conveyorized degreasers were even higher, ranging from 5.14 ppm to 
32,722 ppm for workers, with the 50th percentile and 99th percentile 
being 180.74 ppm and 1162.6 ppm, respectively. For bystanders, the 
levels ranged from 0.63 ppm to 29,410 ppm, with the 50th percentile and 
99th percentile being 80.93 ppm and 745.11 ppm, respectively. The 
estimated 8-hour TWA exposure levels for continuous web degreasers were 
lower overall than for open top vapor degreasing systems or 
conveyorized degreasers. These estimates ranged from 4.18 ppm to 50.61 
ppm for workers, with the 50th percentile and 99th percentile being 
8.18 ppm and 22.42 ppm, respectively. For bystanders, the levels ranged 
from 0.52 ppm to 45.49 ppm, with the 50th percentile and 99th 
percentile being 3.70 ppm and 17.49 ppm, respectively.
    As part of this supplemental analysis, EPA also evaluated the 
exposure reductions that would result from switching from an open top 
vapor degreasing system to a closed-loop vapor degreasing system. The 
data available on TCE emissions from closed-loop systems was not 
sufficient to enable EPA to distinguish between the three types of 
closed-loop systems (airtight, airless, and airless vacuum-to-vacuum) 
with respect to employee exposures. As a result, for the purpose of 
assessing exposure, EPA assumed that all of the closed-loop systems 
achieve a 98% reduction in exposure compared to open top vapor 
degreasing systems (Ref. 30). This assumption leads to exposure 
estimates of 0.05 ppm to 9.8 ppm for workers.
    However, the assumption of a 98% reduction in exposures compared to 
open top vapor degreasing systems may be an overestimate for airtight 
systems, and an underestimate for airless vacuum-to-vacuum systems. EPA 
requests information and data on TCE emissions from all vapor 
degreasing systems, particularly information and data that would enable 
EPA to better distinguish between the different types of closed-loop 
systems.
    The SBAR Panel convened in support of this action heard from 
several SERs who disagreed with EPA's exposure estimates. These SERs 
indicated that fewer employees were involved in the degreasing 
operation, or that the machines were operated for fewer hours per day 
than EPA estimated. However, another SER stated that his degreasing 
machines run ten hours a day during the week and six hours on 
Saturdays, which exceeds EPA's estimate. In addition, most SERs thought 
that EPA's estimated TWAs were too high, and EPA received some 
monitoring data indicating lower exposures, but several SERs stated 
that they complied with the recommended exposure limit of the American 
Conference of Governmental Industrial Hygienists (ACGIH) of 10 ppm, 
which is within the exposure ranges estimated by EPA. However, EPA 
specifically requests exposure data, especially data involving employee 
exposure monitoring.
    e. Specific risks for TCE use in vapor degreasers. Inhalation risks 
were estimated for all acute exposure scenarios and risks were 
identified for all types of machines, regardless of the type of 
exposure (typical vs. reasonable worst case scenario). For acute 
exposures associated with open top vapor degreasing systems, the MOE is 
0.00006 for fetal heart malformations. This equates to exposures that 
are many times greater than the benchmark MOE of 10. The MOE for fetal 
heart malformations from acute exposures associated with conveyorized 
systems is 0.00001, while for continuous web systems, the MOE is 
0.0005. Even for acute exposures with closed-loop systems, which we 
assume reduce TCE emissions as much as 98% from open top vapor 
degreasing systems, the MOE for fetal heart malformations is 0.003. The 
MOEs for every vapor degreasing scenario are below the benchmark MOE. 
Based on this assessment, EPA's proposed determination is that acute 
TCE exposures from vapor degreasing present unreasonable risks.
    Chronic exposures from TCE use in vapor degreasing also present 
risks. For non-cancer effects, the most sensitive of which are 
developmental, the benchmark MOE is also 10. For chronic exposures 
associated with open top vapor degreasing systems, conveyorized 
systems, continuous web systems, and closed-loop systems, the MOEs are 
0.00008, 0.00001, 0.00007, and 0.004, respectively. With respect to 
cancer, the risk posed to workers ranges from 5.16 x 10-1 
for open top vapor degreasing systems to 1 x 10-2 for 
closed-loop systems, exceeding common cancer benchmarks of 
10-6 to 10-4 (Refs. 2, 30). Therefore, EPA's 
proposed determination is that chronic TCE exposures due to vapor 
degreasing also present unreasonable risks.
    The SBAR Panel convened in support of this action heard from 
several SERs who expressed concerns about the underlying TCE risk 
assessment. Many of the concerns expressed by these SERs were already 
expressed in the public comments and the peer review comments on the 
risk assessment. The Summary of External Peer Review and Public 
Comments and Disposition document explains how EPA responded to the 
comments received (Ref. 35).
    2. Initial analysis of potential regulatory options. Having 
identified unreasonable risks from the use of TCE in vapor degreasing, 
EPA evaluated whether regulatory options under TSCA section 6(a) could 
reach the risk (non-cancer and cancer) benchmarks.
    EPA assessed a number of exposure scenarios associated with risk 
reduction options in order to find variations in TCE exposure from 
vapor degreasing, including: Reducing the amount of TCE in the 
degreasing formulation, with concentrations varying from 5% to 95% by 
weight in the product, engineering controls, equipment substitution, 
and use of PPE. EPA also assessed combinations of these options.
    For the engineering controls risk reduction option exposure 
scenarios, EPA evaluated using local exhaust ventilation to improve 
ventilation near the vapor degreaser, with an assumed 90% reduction in 
exposure over baseline levels. The equipment substitution risk 
reduction option was only evaluated with respect to open top vapor 
degreasing systems, the evaluation assumed substitution of a closed-
loop system for the open top

[[Page 7444]]

vapor degreasing system. EPA did not identify any equipment 
substitution options for either conveyorized or continuous web systems; 
it is likely that a closed-loop system, being a batch-process system, 
would not meet the specialized production requirements of facilities 
currently using conveyorized or continuous web systems. EPA requests 
comment, information, and data on potential equipment substitution 
options for these systems, including both emissions and cost 
information. The PPE risk reduction option exposure scenarios evaluated 
workers and occupational bystanders wearing respirators with an 
assigned protection factor (APF) varying from 10 to 10,000. 
Additionally, EPA evaluated various combinations of these options, 
including PPE with each of the other three options and reducing the 
amount of TCE in the solvent solution with each of the other three 
options. The way that closed-loop systems operate may render local 
exhaust ventilation redundant, because ventilation is being done as 
part of the closed system, so EPA did not evaluate local exhaust 
ventilation and equipment substitution together. EPA requests comment 
on the accuracy of EPA's assumption that these control options are 
mutually exclusive.
    EPA has estimated that, in order to avoid cancer and non-cancer 
unreasonable risks, the 8-hour TWA exposure should be approximately 1 
ppb (Ref. 36). However, EPA's inhalation exposure level estimates for 
all types of vapor degreasing machines exceed that figure by several 
orders of magnitude.
    Of the control options evaluated by EPA in its supplemental 
analysis (Ref. 30), which did not include a ban on the use of TCE in 
vapor degreasing, the only control options that achieved the necessary 
exposure reductions for workers operating the degreaser involved PPE in 
addition to other measures. Even switching from an open top vapor 
degreasing system to a closed-loop system did not achieve the necessary 
reductions without the addition of PPE with an APF of 10,000. For that 
control option, equipment substitution plus PPE, EPA estimated that 
worker exposure levels would be 0.4 ppb. Other combinations of control 
options, such as reducing the amount of TCE in the solvent solution and 
PPE with an APF of 10,000, or reducing the amount of TCE in the solvent 
solution and engineering controls and PPE, achieved exposure reductions 
of approximately the same magnitude. However, EPA found that these 
combinations are unlikely to be practical for users because the 
exposure reductions needed would only be achieved by a reduction in the 
concentration of TCE in the degreasing solution to 5%. At 5% TCE, the 
effectiveness of the solution would be greatly reduced. Additional 
exposure level estimates for various scenarios are available in the 
supplemental analysis document, which also documents options that did 
not meet the risk benchmarks and which do not, for purposes of this 
proposal, address the identified unreasonable risks (Ref. 30).
    3. Assessment of whether regulatory options address the identified 
unreasonable risks to the extent necessary so that TCE no longer 
presents such unreasonable risks. After excluding the unrealistic 
options involving reductions in the amount of TCE in the solvent 
solution, only two options were left that had the potential to address 
the identified unreasonable risks. These options were: (a) Prohibiting 
under TSCA section 6(a)(2) the manufacturing (including import), 
processing, and distribution in commerce of TCE for use in vapor 
degreasing, prohibiting the commercial use of TCE in vapor degreasing 
under TSCA section 6(a)(5), and requiring downstream notification under 
TSCA section 6(a)(3) when distributing TCE; and (b) prohibiting under 
TSCA section 6(a)(2) the manufacturing (including import), processing, 
and distribution in commerce of TCE for use in vapor degreasing except 
in closed-loop vapor degreasing machines, prohibiting under TSCA 
section 6(a)(5) the commercial use of TCE in vapor degreasing except in 
closed-loop vapor degreasing machines, requiring downstream 
notification under TSCA section 6(a)(3) when distributing TCE, and 
requiring, under TSCA section 6(a)(5), appropriate PPE (or an exposure 
limit alternative) for both workers operating closed-loop vapor 
degreasing machines containing TCE and for occupational bystanders.
    a. Proposed approach to prohibit manufacturing (including import), 
processing, distribution in commerce, and use of TCE for vapor 
degreasing and require downstream notification. As noted previously, 
the proposed regulatory approach is to prohibit the manufacturing 
(including import), processing, and distribution in commerce of TCE for 
vapor degreasing under TSCA section 6(a)(2), prohibit the commercial 
use of TCE in vapor degreasing under TSCA section 6(a)(5), and require 
manufacturers, processors, and distributors, except for retailers, to 
provide downstream notification, e.g., via a Safety Data Sheet (SDS), 
of the prohibition under TSCA section 6(a)(3).
    As discussed in Unit IV, the baseline risk for exposure to workers 
and occupational bystanders for vapor degreasing does not achieve the 
non-cancer MOE benchmarks for all non-cancer effects (e.g., 
developmental effects, kidney toxicity, and immunotoxicity) or the 
common cancer benchmarks. Under this proposed approach, exposures to 
TCE from use in vapor degreasing would be completely eliminated. As a 
result, both non-cancer and cancer risks from this use of TCE would be 
eliminated.
    The proposed approach would ensure that employees are no longer at 
risk from TCE exposure associated with vapor degreasing. Prohibiting 
the manufacturing (including import), processing and distribution in 
commerce of TCE for use in vapor degreasing would minimize the 
availability of TCE for vapor degreasing. The downstream notification 
of these restrictions ensures that processors, distributors, and other 
purchasers are aware of the manufacturing (including import), 
processing, distribution in commerce and use restrictions for TCE in 
vapor degreasing, and helps to ensure that the rule is effectively 
implemented by discouraging off-label use of TCE manufactured for other 
uses. Downstream notification is important because EPA is not proposing 
to prohibit manufacturing, processing and all uses of TCE, just those 
activities associated with vapor degreasing. This integrated supply 
chain approach is necessary to address the identified unreasonable 
risks presented by the use of TCE in vapor degreasing. In addition, the 
proposed approach would provide staggered compliance dates for 
implementing the prohibition on manufacturing (including import), 
processing, distribution in commerce, and commercial use in order to 
avoid undue impacts on the businesses involved.
    b. Variation of the proposed approach that would allow the use of 
TCE in closed-loop vapor degreasing systems and require under TSCA 
section 6(a)(5) the use of personal protective equipment in vapor 
degreasing operations in which TCE is used. Another regulatory option 
that EPA considered was to allow the use of TCE in closed-loop vapor 
degreasing systems and require respiratory protection equipment for 
workers operating the equipment in the form of a full face piece self-
contained breathing apparatus (SCBA) in pressure demand mode or other 
positive pressure mode with an APF of 10,000 with an alternative to the 
specified APF respirator of an air exposure limit. EPA's analysis found

[[Page 7445]]

that use of a SCBA with an APF of 10,000 for workers operating closed-
loop vapor degreasing systems that contain TCE could control TCE air 
concentration to levels that ensure that TCE no longer presents the 
identified unreasonable risks. Depending on air concentrations and 
proximity to the vapor degreasing equipment, other employees in the 
area would also need to wear respiratory protection equipment.
    Although respirators could reduce exposures to levels that are 
protective of non-cancer and cancer risks, there are many documented 
limitations to successful implementation of respirators with an APF of 
10,000. Not all workers can wear respirators. Individuals with impaired 
lung function, due to asthma, emphysema, or chronic obstructive 
pulmonary disease, for example, may be physically unable to wear a 
respirator. Determination of adequate fit and annual fit testing is 
required for a tight fitting full-facepiece respirator to provide the 
required protection. Also, difficulties associated with selection, fit, 
and use often render them ineffective in actual application, preventing 
the assurance of consistent and reliable protection, regardless of the 
assigned capabilities of the respirator. Individuals who cannot get a 
good facepiece fit, including those individuals whose beards or 
sideburns interfere with the facepiece seal, would be unable to wear 
tight fitting respirators. In addition, respirators may also present 
communication problems and vision problems, increase worker fatigue, 
and reduce work efficiency (Ref. 37). According to OSHA, ``improperly 
selected respirators may afford no protection at all (for example, use 
of a dust mask against airborne vapors), may be so uncomfortable as to 
be intolerable to the wearer, or may hinder vision, communication, 
hearing, or movement and thus pose a risk to the wearer's safety or 
health.'' (Ref. 37, at 1189-1190). Nonetheless, it is sometimes 
necessary to use respiratory protection to control exposure. The OSHA 
respiratory protection standard requires employers to establish and 
implement a respiratory protection program to protect their respirator-
wearing employees (Ref. 38). This OSHA standard contains a number of 
implementation requirements, e.g., for program administration; 
worksite-specific procedures; respirator selection; employee training; 
fit testing; medical evaluation; respirator use; respirator cleaning, 
maintenance, and repair; and other provisions that would be difficult 
to fully implement in some small business settings where they are not 
already using respirators.
    In addition, OSHA adopted a hierarchy of controls established by 
the industrial hygiene community used to protect employees from 
hazardous airborne contaminants, such as TCE (see, e.g., 29 CFR 
1910.134(a)(1), 29 CFR 1910.1000(e), and OSHA's substance specific 
standards in 29 CFR 1910 subpart Z). According to the hierarchy, 
substitution of less toxic substances, engineering controls, 
administrative controls, and work practice controls are the preferred 
method of compliance for protecting employees from airborne 
contaminants and are to be implemented first, before respiratory 
protection is used. OSHA permits respirators to be used where 
engineering controls are not feasible or during an interim period while 
such controls are being implemented.
    Under this approach, a company could choose to use a closed-loop 
system coupled with an air exposure limit. In order to reach the health 
benchmarks, the air exposure limit would have to be 1 ppb as an 8-hour 
TWA. Based on EPA's analysis, the only way to achieve an air exposure 
limit of 1 ppb is with a combination of a closed-loop vapor degreaser 
and a respirator with an APF of 10,000. However, as previously 
discussed, EPA acknowledges that available data is limited, 
particularly with respect to the different types of closed-loop vapor 
degreasers. It is possible that the more sophisticated airless vacuum-
to-vacuum closed-loop systems have lower emissions than EPA estimated, 
and, therefore, respiratory protection with an APF of 10,000 may not be 
necessary for operators. As part of this approach, EPA believes it 
would be necessary to establish employee exposure monitoring 
requirements to ensure that employee exposures are measured accurately 
and that employees are not exposed to the identified unreasonable risks 
associated with TCE use in vapor degreasing. EPA would require upfront 
monitoring representative of each exposed employee's exposures and 
would model the requirements on comparable OSHA requirements as well as 
on the New Chemical Exposure Limit (NCEL) requirements that EPA has 
long used in addressing employee exposure to chemicals undergoing 
review under TSCA section 5 (Refs. 38-39). The requirements would 
specify how and when sampling must be performed and how the samples 
would have to be analyzed.
    EPA is not proposing this option because substitutes for TCE are 
commercially available and implementation of a respiratory protection 
program is likely to be difficult for many vapor degreasing facilities. 
In addition, EPA's economic analysis indicates that this option is more 
expensive than switching to a different solvent or cleaning system. 
However, EPA requests comment, information, and data on the utility and 
feasibility of this option and whether, if it were adopted, it should 
be implemented by specifying the vapor degreasing technology and either 
requiring specific PPE or compliance with an air exposure limit. If EPA 
were to specify both the vapor degreasing technology and the required 
PPE with the alternative air exposure limit in the final rule, EPA 
would require the vapor degreasing system to be an airless vacuum-to-
vacuum closed-loop system and the PPE to have an APF of 10,000 or 
otherwise meet the air exposure limit of 1 ppb as an 8-hour TWA. As 
previously discussed, EPA's assessment of worker exposure from closed-
loop systems relies on an assumption that emissions from each closed-
loop system are 98% less than the emissions from an open top vapor 
degreasing system. EPA is requesting information on whether releases 
from the use of TCE in an airless vacuum-to-vacuum closed-loop system 
would result in air levels that are at or below the air exposure limit 
of 1 ppb. To the extent that EPA receives information that indicates 
that this is the case, EPA would consider finalizing this rule to 
exclude airless vacuum-to-vacuum closed-loop systems. In contrast, this 
assumption of a 98% reduction may be overly generous for the most basic 
of the closed-loop systems, and operators of such systems, even when 
wearing PPE with an APF of 10,000, would continue to be exposed to the 
identified unreasonable risks. Under the optional approach, companies 
choosing to keep using TCE would have to comply with all of OSHA's 
requirements for respiratory protection programs, including fit-testing 
and medical monitoring.

C. Adverse Health Effects and Related Impacts That Would Be Prevented 
by the Proposed Option

    The proposed option would prevent exposure to TCE from vapor 
degreasing and thus would prevent the risks of adverse effects and 
associated impacts. As discussed in Unit IV., TCE exposure is 
associated with a wide array of adverse health effects. These health 
effects include those resulting from developmental toxicity (e.g., 
cardiac malformations, developmental immunotoxicity, developmental 
neurotoxicity, fetal death), toxicity to

[[Page 7446]]

the kidney (kidney damage and kidney cancer), immunotoxicity (systemic 
autoimmune diseases such as 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. 2). These health effects associated with 
exposure to TCE are serious and can have impacts throughout a lifetime. 
The following is a discussion of the impacts of significant acute, 
chronic non-cancer, and cancer effects associated with TCE exposure 
during vapor degreasing, including the severity of the effect, the 
manifestation of the effect, and how the effect impacts a person during 
their lifetime.
    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 
estimated 454 to 1,066 pregnant women exposed to TCE during the use of 
vapor degreasers (Ref. 3). 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 
are the effect of greatest concern and are 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., reduced growth, decreased survival, developmental 
neurotoxicity, developmental immunotoxicity, and childhood cancers) 
effects. TCE exposure during development results in qualitatively 
different immunotoxic effects than when exposure occurs during 
adulthood. TCE exposure during development can influence the 
development of the immune system and result in impairment of the immune 
system's ability to respond to infection, whereas TCE exposures during 
adulthood result in a more pronounced immune effect related to 
autoimmune responses.
    Cardiac defects, which can result from 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 TCE can cause.
    Nearly 1% or about 40,000 births per year in the United States are 
affected by cardiac defects (Ref. 40). 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. 40). 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. 41). A child with a 
cardiac defect is 50% more likely to receive special education services 
compared to a child without birth defects (Ref. 40).
    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, making it difficult to predict and 
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. 40).
    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. 40).
    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. 41). 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. 
41). 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 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

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number of cases avoided can be estimated, their impact should be 
considered.
    2. Kidney toxicity. a. Non-cancer chronic effects. The TCE risk 
assessment identified kidney toxicity as a significant concern from TCE 
exposure with the risk from this non-cancer effect being from chronic 
exposure. There are increased health risks for kidney toxicity to the 
approximately 2,670 to 6,270 workers and 42,720 to 100,320 occupational 
bystanders in facilities that use TCE for vapor degreasing, where 
exposure to TCE is a result of vapor degreasing operations (Ref. 3).
    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. 42).
    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. 43).
    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. 44).
    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.
    b. Cancer effects. Chronic exposure to TCE can also lead to kidney 
cancer. The estimated value of the annualized benefit is $12 million to 
$108 million at 3% and $6 million to $57 million at 7% over 20 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 and treatment impacts of 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 effect 
that is associated with TCE exposure. There are increased health risks 
for immunotoxicity to the approximately 2,670 to 6,270 workers and 
42,720 to 100,320 bystanders exposed to TCE as a result of vapor 
degreasing operations (Ref. 3).
    Human studies have demonstrated that TCE exposed workers can suffer 
from systemic autoimmune diseases (e.g., scleroderma) and severe 
hypersensitivity skin disorders. 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. 45), and the 
prevalence is four to 253 cases per 1 million persons (Ref. 46). 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. 
46).
    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. 46).
    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 disorders include 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. 45).
    The monetary costs for treating these various immunotoxicity 
disorders will vary depending upon whether the symptoms lead to early 
diagnosis and this early diagnosis can then influence whether symptoms 
progress to mild or life-threatening outcomes. For mild symptoms, 
doctors' visits and outpatient treatment could be sufficient, 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

[[Page 7448]]

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. Cancer effects: 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[hyphen]Hodgkin's 
lymphoma (NHL), one of the three cancers for which the EPA IRIS TCE 
assessment based its cancer findings. There are increased health risks 
for NHL for the approximately 2,670 to 6,270 workers and 42,720 to 
100,320 occupational bystanders exposed to TCE as a result of vapor 
degreasing operations (Ref. 3).
    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. 47). 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. 48).
    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 to secondary malignancies (Ref. 49). 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. The 
estimated value of the monetized benefit is $32 million to $201 million 
at 3% and $15 million to $98 million at 7% annualized over 20 years.
    4. Reproductive and endocrine effects. The TCE risk assessment 
identified risks of chronic non-cancer reproductive effects for workers 
and bystanders exposed to TCE. There are increased health risks for 
reproductive effects for the approximately 2,670 to 6,270 workers and 
42,720 to 100,320 occupational bystanders exposed to TCE as a result of 
vapor degreasing operations (Ref. 3).
    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. 
50). For females, there can be reduced incidence of fecundability (6.7 
million women ages 15 to 44 or 10.9% affected) (Ref. 51), increase in 
abnormal menstrual cycles, 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. 52). Low T levels are associated with aging; an 
estimated 39% of men 45 or older have hypogonadism, resulting in low T 
levels (Ref. 53). 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 a diagnosis. 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 
other non-cancer 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 must consider their impact.
    5. Neurotoxicity. The TCE risk assessment identified neurotoxicity 
risks for workers and bystanders from chronic TCE exposures. There are 
increased health risks of neurotoxicity for the approximately 2,670 to 
6,270 workers and 42,720 to 100,320 occupational bystanders exposed to 
TCE as a result of vapor degreasing operations (Ref. 3).
    Studies have also demonstrated neurotoxicity from acute exposures. 
Neurotoxic effects observed include 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 
include delayed newborn reflexes, impaired learning or memory, 
aggressive behavior, hearing impairment, speech impairment, 
encephalopathy, impaired executive and motor function and attention 
deficit (Ref. 4).
    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 an adolescent's schooling and ability to make friends, 
which in turn can impact the type of work or ability to 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. 54). 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

[[Page 7449]]

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

D. Availability of Alternatives

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

[[Page 7450]]

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

[[Page 7451]]

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

E. Impacts of the Proposed and Alternative Regulatory Options

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

[[Page 7452]]

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

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

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

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

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

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

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

[[Page 7453]]

C. Comparison of Benefits and Costs

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

VIII. Overview of Uncertainties

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

[[Page 7454]]

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

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

A. TSCA Section 9(a) Analysis

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

[[Page 7455]]

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

B. TSCA Section 9(b) Analysis

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

C. Section 26(h) Considerations

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

X. Major Provisions and Enforcement of the Proposed Rule

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

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

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

B. Downstream Notification

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

[[Page 7456]]

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

C. Enforcement

    TSCA section 15 makes it unlawful to fail or refuse to comply with 
any provision of a rule promulgated under TSCA section 6. Therefore, 
any failure to comply with this proposed rule when it becomes effective 
would be a violation of TSCA section 15. In addition, TSCA section 15 
makes it unlawful for any person to: (1) Fail or refuse to establish 
and maintain records as required by this rule; (2) fail or refuse to 
permit access to or copying of records, as required by TSCA; or (3) 
fail or refuse to permit entry or inspection as required by TSCA 
section 11.
    Violators may be subject to both civil and criminal liability. 
Under the penalty provision of TSCA section 16, any person who violates 
TSCA section 15 could be subject to a civil penalty for each violation. 
Each day of operation in violation of this proposed rule when it 
becomes effective could constitute a separate violation. Knowing or 
willful violations of this proposed rule when it becomes effective 
could lead to the imposition of criminal penalties and imprisonment. In 
addition, other remedies are available to EPA under TSCA sections 7 and 
17.
    Individuals, as well as corporations, could be subject to 
enforcement actions. TSCA sections 15 and 16 apply to ``any person'' 
who violates various provisions of TSCA. EPA may, at its discretion, 
proceed against individuals as well as companies. In particular, EPA 
may proceed against individuals who report false information or cause 
it to be reported.

D. Implementation Dates and Incentives

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

[[Page 7457]]

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

XI. References

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

1. EPA. Trichloroethylene; Regulation of Certain Uses under TSCA 
Sec.  6(a). Proposed Rule. Federal Register. (81 FR 91592, December 
16, 2016) (FRL-9949-86).
2. 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.
3. EPA (US Environmental Protection Agency). 2016. Economic 
Assessment for Trichloroethylene (TCE) under TSCA Section 6. Office 
of Chemical Safety and Pollution Prevention, Washington, DC.
4. EPA. Toxicological Review of Trichloroethylene (CAS No. 79-01-6). 
EPA/-635/R[hyphen]09/011F. Integrated Risk Information System, 
Washington, DC. 2011.
5. EPA. Guidelines for Developmental Toxicity Risk Assessment. EPA/
600/FR-91/001. December 1991.
6. EPA. Policy on Evaluating Health Risks to Children. October 20, 
1995.
7. 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.
8. National Toxicology Program. 12th Report on Carcinogens. 2011. 
Available at http://ntp.niehs.nih.gov/go/37899.
9. 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).
10. EPA. Trichloroethylene; Significant New Use Rule. Final Rule. 
Federal Register (81 FR 20535, April 8, 2016) (FRL-9943-83).
11. Occupational Safety and Health Administration (OSHA). 
Occupational Safety and Health Standards, Toxic and Hazardous 
Substances. Code of Federal Regulations 29 CFR 1910.1000. 1998.
12. 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.
13. 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.
14. American Conference of Governmental Industrial Hygienists 
(ACGIH), Threshold Limit Values & Biological Exposure Indices for 
2003, ACGIH, Cincinnati, OH, 2003.
15. Cal. Code Regs. Title 17, Sec.  94509 (2013).
16. Toxics Use Reduction Institute (TURI). 2013. http://www.turi.org/TURI_Publications/TURI_Chemical_Fact_Sheets/Trichloroethylene_TCE_Fact_Sheet.
17. 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.
18. LawAtlas: The Policy Surveillance Portal. http://lawatlas.org/. 
Retrieved April 4, 2016.
19. European Chemicals Agency. Substance Information: 
Trichloroethylene. http://echa.europa.eu/da/substance-information/-/substanceinfo/100.001.062. Retrieved February 25, 2016.
20. European Chemicals Association. Opinion on an Application for 
Authorisation for Trichloroethylene: Industrial use of 
trichloroethylene (TCE) as a solvent as a degreasing agent in closed 
systems (15 July 2015).
21. European Chemicals Association. Opinion on an Application for 
Authorisation for Trichloroethylene: Use of Trichloroethylene in 
Industrial Parts Cleaning by Vapour Degreasing in Closed Systems 
where specific requirements (system of use-parameters) exist (11 
September 2015).
22. 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.
23. 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.
24. 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.
25. 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.
26. 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.
27. 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.
28. EPA. A Review of the Reference Dose and Reference Concentration 
Processes. EPA/630/P-02/002F. December 2002.
29. 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.
30. EPA. Supplemental Occupational Exposure and Risk Reduction 
Technical Report in Support of Risk Management Options for 
Trichloroethylene (TCE) Use in Vapor Degreasing. Office of Chemical 
Safety and Pollution Prevention. Washington, DC 2016.
31. 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.
32. EPA. Final Report of the Small Business Advocacy Review Panel on 
EPA's Planned Proposed Rule Under Section 6(a) of the Toxic 
Substances Control Act (TSCA) as amended by the Frank R. Lautenberg 
Chemical Safety for the 21st Century Act for Use of 
Trichloroethylene (TCE) in Vapor Degreasing. Office of Chemical 
Safety and Pollution Prevention. Washington, DC August, 2016.
33. EPA. The Effectiveness of Labeling on Hazardous Chemicals and 
Other Products. Office of Chemical Safety and Pollution Prevention. 
Washington, DC 2016.
34. Unintended pregnancy in the United States: Incidence and 
disparities, 2006. Contraception. 2011;84(5):478-485.
35. EPA. Summary of External Peer Review and Public Comments and 
Disposition.
36. 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.
37. OSHA. Respiratory Protection. Final rule; request for comment on 
paperwork requirements. Federal Register (63 FR 1152 January 9, 
1998).
38. OSHA. Respiratory Protection Standard. 29 CFR 1910.134.
39. EPA. Section 5(e) Consent Order New Chemicals Exposure Limits 
(NCEL) Insert.
40. CDC. Facts about Congenital Heart Defects http://www.cdc.gov/
ncbddd/

[[Page 7458]]

heartdefects/facts.html. December 22, 2015. Accessed March 1, 2016.
41. 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.
42. Mayo clinic. Chronic kidney disease. http://www.mayoclinic.org/diseases-conditions/kidney-disease/basics/definition/con-20026778. 
January 30, 2015.
43. American Kidney Fund. 2015 Kidney Disease Statistics. http://www.kidneyfund.org/about-us/assets/pdfs/kidney_disease_statistics_2015.pdf.
44. The Kidney Boy. The Cost of Dialysis. http://thekidneyboy.blogspot.com/2011/01/cost-of-dialysis.html. January 20, 
2011.
45. 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.
46. Lawrence RC, Helmick CG, Arnett FC, et al. Estimates of the 
prevalence of arthritis and selected musculoskeletal disorders in 
the United States. Arthritis Rheum. 1998;41(5):778-799. Cited in 
Hinchcliff, M.; Varga, Systemic sclerosis/scleroderma: A treatable 
multisystem disease. J. Am Fam Physician. 2008 Oct 15;78(8):961-8.
47. National Cancer Institute. SEER Stat Fact Sheets: Non-Hodgkin 
Lymphoma. Bethesda, MD. http://seer.cancer.gov/statfacts/html/nhl.html. Retrieved March 16, 2016. Mayo Clinic.
48. Non-Hodgkin's lymphoma Risk Factors. January 28, 2016. http://www.mayoclinic.org/diseases-conditions/non-hodgkins-lymphoma/basics/risk-factors/con-20027792. Retrieved March 7, 2016.
49. Morton LM, Curtis RE, Linet MS, et al. Second Malignancy Risks 
After Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia: 
Differences by Lymphoma Subtype. Journal of Clinical Oncology. 
2010;28(33):4935-4944. doi:10.1200/JCO.2010.29.1112.
50. Sharma R, Biedenharn KR, Fedor JM, Agarwal A. Lifestyle factors 
and reproductive health: Taking control of your fertility. 
Reproductive Biology and Endocrinology: RB&E. 2013;11:66. 
doi:10.1186/1477-7827-11-66.
51. CDC. National Center for Health Statistics--Infertility. 
February 6, 2015. http://www.cdc.gov/nchs/fastats/infertility.htm. 
Retrieved March 16, 2016.
52. Gruenewald DA, Matsumoto AM. Testosterone supplementation 
therapy for older men: Potential benefits and risks. J Am Geriatr 
Soc. 2003;51(1):101-115.
53. Dadona P, Rosenberg MT. A practical guide to male hypogonadism 
in the primary care setting. Int J Clin Pract. 2010;64(6):682-696.
54. International Association for the Study of Pain. http://www.iasp-pain.org/files/Content/ContentFolders/GlobalYearAgainstPain2/20132014OrofacialPain/FactSheets/Trigeminal_Neuralgia.pdf. 2013.
55. American Liver Foundation. Non-Alcoholic Fatty Liver Disease 
(NAFLD). http://www.liverfoundation.org/abouttheliver/info/nafld/. 
January 14, 2015. Retrieved April 4, 2016.
56. CDC. Viral Hepatitis--Statistics and Surveillance. http://www.cdc.gov/hepatitis/Statistics/index.htm. May 31, 2014. Retrieved 
April 4, 2016.
57. United Network for Organ Sharing (UNOS) Transplant Living. 
Financing a Transplant--Costs. December 28, 2011. Available athttp:/
/transplantliving.org/before-the-transplant/financing-a-transplant/the-costs/. Retrieved March 16, 2016.
58. EPA. Analysis Report of Alternatives in Support of Risk 
Management Options for Use of TCE in Vapor Degreasing, Office of 
Chemical Safety and Pollution Prevention. Washington, DC. 2016.
59. EPA. Petition to Add n-Propyl Bromide to the List of Hazardous 
Air Pollutants. Receipt of a complete petition. (80 FR 6676, 
February 6, 2015) (FRL-9922-13).
60. EPA. 2014. TSCA Work Plan Chemical Risk Assessment. Methylene 
Chloride, Paint Stripping Use. CASRN: 75-09-2. EPA/740/R1/4002. 
Office of Chemical Safety and Pollution Prevention, Washington, DC. 
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-risk-assessment-methylene.
61. EPA. 2016. TSCA Work Plan Chemical Risk Assessment PEER REVIEW 
DRAFT. 1-Bromopropane: (n-Propyl Bromide). Spray Adhesives, Dry 
Cleaning, and Degreasing Uses. CASRN: 106-94-5. EPA/740/R1/5001. 
Office of Chemical Safety and Pollution Prevention, Washington, DC. 
https://www.epa.gov/sites/production/files/2016-03/documents/1-bp_report_and_appendices_final.pdf.
62. EPA. 2012. Toxicological Review of Tetrachloroethylene 
(Perchloroethylene) (CAS No. 127-18-4) in Support of Summary 
Information on the Integrated Risk Information System (IRIS) 
(February 2012).
63. EPA. Evaluation of Water-Based Cleaners. Office of Chemical 
Safety and Pollution Prevention. Washington, DC. 2016.
64. Institute for Research and Technical Assistance. Memo from Katy 
Wolf to Emily Connor at ABT Associates. May 15, 2015.
65. EPA. Information Collection Request (ICR) for the Regulation of 
Use in Vapor Degreasing under TSCA Sec.  6(a) (Proposed Rule). EPA 
ICR No. 2541.02 and OMB No. 2070-[NEW].
66. EPA. Initial Regulatory Flexibility Analysis for 
Trichloroethylene (TCE); Regulation of Use in Vapor Degreasing under 
TSCA Sec.  6(a); Proposed Rule. January 2017.
67. EPA. Section 6(a) Rulemakings under the Toxic Substances Control 
Act (TSCA) Paint Removers & TCE Rulemakings E.O. 13132: Federalism 
Consultation. May 13, 2015.
68. EPA. Notification of Consultation and Coordination on Proposed 
Rulemakings under the Toxic Substances Control Act for (1) Methylene 
Chloride and n-Methylpyrrolidone in Paint Removers and (2) 
Trichloroethylene in Certain Uses. April 8, 2015.

XII. Statutory and Executive Order Reviews

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

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

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

B. Paperwork Reduction Act (PRA)

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

[[Page 7459]]

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

C. Regulatory Flexibility Act (RFA)

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

[[Page 7460]]

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

D. Unfunded Mandates Reform Act (UMRA)

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

E. Executive Order 13132: Federalism

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

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

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

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

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

[[Page 7461]]

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

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

I. National Technology Transfer and Advancement Act (NTTAA)

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

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

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

List of Subjects in 40 CFR Part 751

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

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

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

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

    Authority:  15 U.S.C. 2605.

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


Sec.  751.303  Definitions.

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


Sec.  751.309  Vapor degreasing.

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

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



                                                      7432                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      ENVIRONMENTAL PROTECTION                                and general guidance on making                           • Plastics Material and Resin
                                                      AGENCY                                                  effective comments, please visit http://               Manufacturing (NAICS code 325211).
                                                                                                              www2.epa.gov/dockets/commenting-                         • Synthetic Rubber Manufacturing
                                                      40 CFR Part 751                                         epa-dockets.                                           (NAICS code 325212).
                                                      [EPA–HQ–OPPT–2016–0387; FRL–9950–08]                       Docket. Docket ID No. EPA–HQ–                         • Paint and Coating Manufacturing
                                                                                                              OPPT–2016–0387 contains supporting                     (NAICS code 325510).
                                                      RIN 2070–AK11                                           information used in developing the                       • Adhesive Manufacturing (NAICS
                                                                                                              proposed rule, comments on the                         code 325520).
                                                      Trichloroethylene (TCE); Regulation of                  proposed rule, and additional                            • Soap and Other Detergent
                                                      Use in Vapor Degreasing Under TSCA                      supporting information. In addition to                 Manufacturing (NAICS code 325611).
                                                      Section 6(a)                                            being available online at http://                        • Polish and Other Sanitation Good
                                                      AGENCY:  Environmental Protection                       www.regulations.gov, the docket is                     Manufacturing (NAICS code 325612).
                                                      Agency (EPA).                                           available for inspection and copying                     • All Other Miscellaneous Chemical
                                                      ACTION: Proposed rule.                                  between 8:30 a.m. and 4:30 p.m.,                       Product and Preparation Manufacturing
                                                                                                              Monday through Friday, excluding                       (NAICS code 325998).
                                                      SUMMARY:    Trichloroethylene (TCE) is a                federal holidays, at the U.S.                            • Unlaminated Plastics Film and
                                                      volatile organic compound widely used                   Environmental Protection Agency, EPA                   Sheet (except Packaging) Manufacturing
                                                      in industrial and commercial processes                  Docket Center Reading Room, WJC West                   (NAICS code 326113).
                                                      and has some limited uses in consumer                   Building, Room 3334, 1301 Constitution                   • All Other Plastics Product
                                                      and commercial products. EPA                            Avenue NW., Washington, DC 20004. A                    Manufacturing (NAICS code 326199).
                                                      identified significant health risks                     reasonable fee may be charged for                        • Rubber and Plastics Hoses and
                                                      associated with TCE use in vapor                        copying.                                               Belting Manufacturing (NAICS code
                                                      degreasing and EPA’s proposed                                                                                  326220).
                                                                                                              FOR FURTHER INFORMATION CONTACT:    For
                                                      determination is that these risks are
                                                                                                              technical information contact: Cindy                     • All Other Rubber Product
                                                      unreasonable risks. To address these                                                                           Manufacturing (NAICS code 326299).
                                                                                                              Wheeler, Chemical Control Division
                                                      unreasonable risks, EPA is proposing
                                                                                                              (7405M), Office of Pollution Prevention                  • Cement Manufacturing (NAICS
                                                      under section 6 of the Toxic Substances                                                                        code 327310).
                                                                                                              and Toxics, Environmental Protection
                                                      Control Act (TSCA) to prohibit the
                                                                                                              Agency, 1200 Pennsylvania Ave. NW.,                      • Ground or Treated Mineral and
                                                      manufacture (including import),                                                                                Earth Manufacturing (NAICS code
                                                                                                              Washington, DC 20460–0001; telephone
                                                      processing, and distribution in                                                                                327992).
                                                                                                              number: (202) 566–0484; email address:
                                                      commerce of TCE for use in vapor
                                                                                                              wheeler.cindy@epa.gov.                                   • Iron and Steel Pipe and Tube
                                                      degreasing; to prohibit commercial use                                                                         Manufacturing from Purchased Steel
                                                                                                                For general information contact: The
                                                      of TCE in vapor degreasing; to require                                                                         (NAICS code 331210).
                                                                                                              TSCA-Hotline, ABVI-Goodwill, 422
                                                      manufacturers, processors, and
                                                                                                              South Clinton Ave., Rochester, NY                        • Steel Wire Drawing (NAICS code
                                                      distributors, except for retailers of TCE                                                                      331222).
                                                                                                              14620; telephone number: (202) 554–
                                                      for any use, to provide downstream
                                                                                                              1404; email address: TSCA-Hotline@                       • Copper Rolling, Drawing,
                                                      notification of these prohibitions                                                                             Extruding, and Alloying (NAICS code
                                                                                                              epa.gov.
                                                      throughout the supply chain; and to                                                                            331420)
                                                      require limited recordkeeping.                          SUPPLEMENTARY INFORMATION:                               • Nonferrous Metal (except Copper
                                                      DATES: Comments must be received on                     I. Executive Summary                                   and Aluminum) Rolling, Drawing, and
                                                      or before March 20, 2017.                                                                                      Extruding (NAICS code 331491).
                                                      ADDRESSES: Submit your comments,
                                                                                                              A. Does this action apply to me?                         • Nonferrous Metal Die-Casting
                                                      identified by docket identification (ID)                   You may be potentially affected by                  Foundries (NAICS code 331523).
                                                      number EPA–HQ–OPPT–2016–0387, at                        this proposed action if you manufacture                  • Powder Metallurgy Part
                                                      http://www.regulations.gov. Follow the                  (defined under TSCA to include                         Manufacturing (NAICS code 332117).
                                                      online instructions for submitting                      import), process, or distribute in                       • Metal Crown, Closure, and Other
                                                      comments. Once submitted, comments                      commerce TCE or commercially use                       Metal Stamping (except Automotive)
                                                      cannot be edited or withdrawn. EPA                      TCE in vapor degreasers. The following                 (NAICS code 332119).
                                                      may publish any comment received to                     list of North American Industrial                        • Saw Blade and Hand Tool
                                                      its public docket. Do not submit                        Classification System (NAICS) codes is                 Manufacturing (NAICS code 332216).
                                                      electronically any information you                      not intended to be exhaustive, but rather                • Metal Window and Door
                                                      consider to be Confidential Business                    provides a guide to help readers                       Manufacturing (NAICS code 332321).
                                                      Information (CBI) or other information                  determine whether this document                          • Power Boiler and Heat Exchanger
                                                      whose disclosure is restricted by statute.              applies to them. Potentially affected                  Manufacturing (NAICS code 332410).
                                                      Multimedia submissions (audio, video,                   entities may include:                                    • Other Fabricated Wire Product
                                                      etc.) must be accompanied by a written                     • Petroleum Refineries (NAICS code                  Manufacturing (NAICS code 332618).
                                                      comment. The written comment is                         324110).                                                 • Machine Shops (NAICS code
                                                      considered the official comment and                        • Petroleum Lubricating Oil and                     332710).
                                                      should include discussion of all points                 Grease Manufacturing (NAICS code                         • Precision Turned Product
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      you wish to make. EPA will generally                    324191).                                               Manufacturing (NAICS code 332721).
                                                      not consider comments or comment                           • Petrochemical Manufacturing                         • Bolt, Nut, Screw, Rivet, and Washer
                                                      contents located outside of the primary                 (NAICS code 325110).                                   Manufacturing (NAICS code 332722).
                                                      submission (i.e., on the Web, cloud, or                    • Industrial Gas Manufacturing                        • Metal Heat Treating (NAICS code
                                                      other file sharing system). For                         (NAICS code 325120).                                   332811).
                                                      additional submission methods (e.g.,                       • Other Basic Inorganic Chemical                      • Metal Coating, Engraving (except
                                                      mail or hand delivery), the full EPA                    Manufacturing (NAICS code 325180).                     Jewelry and Silverware), and Allied
                                                      public comment policy, information                         • All Other Basic Organic Chemical                  Services to Manufacturers (NAICS code
                                                      about CBI or multimedia submissions,                    Manufacturing (NAICS code 325199).                     332812).


                                                 VerDate Sep<11>2014   01:01 Jan 19, 2017   Jkt 241001   PO 00000   Frm 00002   Fmt 4701   Sfmt 4702   E:\FR\FM\19JAP7.SGM   19JAP7


                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                            7433

                                                        • Electroplating, Plating, Polishing,                 rules under TSCA. Persons who import                   to health. Accordingly, EPA is
                                                      Anodizing, and Coloring (NAICS code                     any chemical substance governed by a                   proposing under TSCA section 6 to
                                                      332813).                                                final TSCA section 6(a) rule are subject               prohibit the manufacture (including
                                                        • Oil and Gas Field Machinery and                     to the TSCA section 13 (15 U.S.C. 2612)                import), processing, and distribution in
                                                      Equipment Manufacturing (NAICS code                     import certification requirements and                  commerce of TCE for use in vapor
                                                      333132).                                                the corresponding regulations at 19 CFR                degreasing; to prohibit commercial use
                                                        • Cutting Tool and Machine Tool                       12.118 through 12.127; see also 19 CFR                 of TCE in vapor degreasing; and to
                                                      Accessory Manufacturing (NAICS code                     127.28. Those persons must certify that                require manufacturers, processors, and
                                                      333515).                                                the shipment of the chemical substance                 distributors, except for retailers, to
                                                        • Small Arms, Ordnance, and                           complies with all applicable rules and                 provide downstream notification of this
                                                      Ordnance Accessories Manufacturing                      orders under TSCA. The EPA policy in                   prohibition throughout the supply chain
                                                      (NAICS code 332994).                                    support of import certification appears                (e.g., via a Safety Data Sheet (SDS)), and
                                                        • Fluid Power Pump and Motor                          at 40 CFR part 707, subpart B. In                      to keep records. The application of this
                                                      Manufacturing (NAICS code 333996).                      addition, any persons who export or                    supply chain approach is necessary so
                                                        • All Other Miscellaneous Fabricated                  intend to export a chemical substance                  that TCE no longer presents the
                                                      Metal Product Manufacturing (NAICS                      that is the subject of this proposed rule              identified unreasonable risks. EPA is
                                                      code 332999).                                           are subject to the export notification                 requesting public comment on this
                                                        • Oil and Gas Field Machinery and                     provisions of TSCA section 12(b) (15                   proposal.
                                                      Equipment Manufacturing (NAICS code                     U.S.C. 2611(b)), and must comply with                     This proposal is related to the
                                                      333132).                                                the export notification requirements in                proposed rule on TCE aerosol
                                                        • Industrial and Commercial Fan and                   40 CFR part 707, subpart D.                            degreasing and spot cleaning in dry
                                                      Blower and Air Purification Equipment                      If you have any questions regarding                 cleaning facilities that published in the
                                                      Manufacturing (NAICS code 333413).                      the applicability of this proposed action              Federal Register on December 16, 2016
                                                        • Cutting Tool and Machine Tool                       to a particular entity, consult the                    (81 FR 91592) (FRL–9949–86) (Ref. 1).
                                                      Accessory Manufacturing (NAICS code                     technical information contact listed                   This proposal and the earlier proposal
                                                      333515).                                                under FOR FURTHER INFORMATION                          together address risks for workers and
                                                        • Pump and Pumping Equipment                          CONTACT.                                               consumers associated with exposure to
                                                      Manufacturing (NAICS code 333911).                                                                             TCE through inhalation that were
                                                                                                              B. What is the Agency’s authority for
                                                        • Fluid Power Pump and Motor                                                                                 identified in the 2014 TCE risk
                                                                                                              taking this action?
                                                      Manufacturing (NAICS code 333996).                                                                             assessment and EPA intends to finalize
                                                        • Search, Detection, Navigation,                        Under TSCA section 6(a) (15 U.S.C.                   both actions together.
                                                      Guidance, Aeronautical, and Nautical                    2605(a)), if EPA determines after risk
                                                                                                              evaluation that a chemical substance                   D. Why is the Agency taking this action?
                                                      System and Instrument Manufacturing
                                                      (NAICS code 334511).                                    presents an unreasonable risk of injury                   Based on EPA’s analysis of worker
                                                        • Automatic Environmental Control                     to health or the environment, without                  exposures to TCE, EPA’s proposed
                                                      Manufacturing for Residential,                          consideration of costs or other non-risk               determination is that the use of TCE in
                                                      Commercial, and Appliance Use (NAICS                    factors, including an unreasonable risk                vapor degreasing presents an
                                                      code 334512).                                           to a potentially exposed or susceptible                unreasonable risk to human health.
                                                        • Motor and Generator Manufacturing                   subpopulation identified as relevant to                More specifically, this use results in
                                                      (NAICS code 335312).                                    the risk evaluation, under the                         significant non-cancer risks under both
                                                        • Primary Battery Manufacturing                       conditions of use, EPA must by rule                    acute and chronic exposure scenarios
                                                      (NAICS code 335912).                                    apply one or more requirements to the                  and significant cancer risks from
                                                        • Carbon and Graphite Product                         extent necessary so that the chemical                  chronic exposures. These adverse health
                                                      Manufacturing (NAICS code 335991).                      substance or mixture no longer presents                effects include those resulting from
                                                        • Motor Vehicle Brake System                          such risk.                                             developmental toxicity (e.g., cardiac
                                                      Manufacturing (NAICS code 336340).                        For a chemical substance listed in the               malformations, developmental
                                                        • Aircraft Manufacturing (NAICS                       2014 update to the TSCA Work Plan for                  immunotoxicity, developmental
                                                      code 336411).                                           Chemical Assessments for which a                       neurotoxicity, fetal death), toxicity to
                                                        • Other Aircraft Parts and Auxiliary                  completed risk assessment was                          the kidney (kidney damage and kidney
                                                      Equipment Manufacturing (NAICS code                     published prior to the date of enactment               cancer), immunotoxicity (such as
                                                      336413).                                                of the Frank R. Lautenberg Chemical                    systemic autoimmune diseases, e.g.,
                                                        • Guided Missile and Space Vehicle                    Safety for the 21st Century Act, TSCA                  scleroderma, and severe
                                                      Manufacturing (NAICS code 336414).                      section 26(l)(4) expressly authorizes                  hypersensitivity skin disorder), non-
                                                        • Ship Building and Repairing                         EPA to issue rules under TSCA section                  Hodgkin’s lymphoma, reproductive and
                                                      (NAICS code 336611).                                    6(a) that are consistent with the scope                endocrine effects (e.g., decreased libido
                                                        • Dental Equipment and Supplies                       of the completed risk assessment and                   and potency), neurotoxicity (e.g.,
                                                      Manufacturing (NAICS code 339114).                      consistent with the other applicable                   trigeminal neuralgia), and toxicity to the
                                                        • Other Chemical and Allied                           requirements of TSCA section 6. TCE is                 liver (impaired functioning and liver
                                                      Products Merchant Wholesalers (NAICS                    such a chemical substance. It is listed in             cancer) (Ref. 2). TCE may cause fetal
                                                      code 424690).                                           the 2014 update to the TSCA Work Plan                  cardiac malformations that begin in
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                                                        • Petroleum Bulk Stations and                         and the completed risk assessment was                  utero. Cardiac malformations can be
                                                      Terminals (NAICS code 424710).                          published on June 25, 2014. The scope                  irreversible and impact a person’s
                                                        • Hazardous Waste Treatment and                       of the completed risk assessment                       health for a lifetime. In addition, fetal
                                                      Disposal (NAICS code 562211).                           includes vapor degreasing.                             death, possibly resulting from cardiac
                                                        • Solid Waste Combustors and                                                                                 malformation, can be caused by
                                                      Incinerators (NAICS code 562213).                       C. What action is the Agency taking?                   exposure to TCE. In utero exposure to
                                                        This action may also affect certain                     EPA’s proposed determination is that                 TCE may cause other effects, such as
                                                      entities through pre-existing import                    the use of TCE in vapor degreasing                     damage to the developing immune
                                                      certification and export notification                   presents an unreasonable risk of injury                system, which manifest later in adult


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                                                      7434                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      life and can have long-lasting health                   firms distribute TCE for these two sets                proposed regulatory action is protective
                                                      impacts. Certain effects that follow adult              of uses.                                               of the fetal heart malformation endpoint
                                                      exposures, such as kidney and liver                        Although TCE causes a wide range of                 and, for the exposed population as a
                                                      cancer, may develop many years after                    non-cancer adverse effects and cancer,                 whole, the proposal is also protective of
                                                      initial exposure.                                       monetized benefits included only                       cancer risk. In addition, the supporting
                                                         As discussed in Unit I.C., EPA is not                benefits associated with reducing cancer               non-cancer risk analysis of children and
                                                      proposing to prohibit all manufacturing,                risks. The Agency does not have                        women of childbearing age conducted
                                                      processing, distribution in commerce,                   sufficient information to include a                    in the TSCA Chemical Work Plan Risk
                                                      and use of TCE. As such, the application                quantification or valuation estimate for               Assessment for TCE (Ref. 2) also meets
                                                      of this proposal’s supply chain                         non-cancer benefits in the overall                     the 1995 EPA Policy on Evaluating
                                                      approach tailored to specific uses that                 benefits at this time. The monetized                   Health Risks to Children (Ref. 6).
                                                      present unreasonable risks to human                     benefits for the proposed approach                     Supporting information on TCE
                                                      health is necessary so that the chemical                range from approximately $65 to $443                   exposures and the health effects of TCE
                                                      substance no longer presents the                        million on an annualized basis over 20                 exposure on children are also available
                                                      identified unreasonable risks.                          years at 3% and $31 million to $225                    in the IRIS Toxicological Review of
                                                                                                              million at 7% (Ref. 3). The non-                       Trichloroethylene (Ref. 4) and the TSCA
                                                      E. What are the estimated incremental
                                                                                                              monetized benefits resulting from the                  Chemical Work Plan Risk Assessment
                                                      impacts of this action?
                                                                                                              prevention of the non-cancer adverse                   on Trichloroethylene (Ref. 2), as well as
                                                         EPA has evaluated the potential costs                effects associated with TCE exposure                   Unit VI of this preamble.
                                                      of multiple regulatory options,                         from use in vapor degreasers include
                                                      including the proposed approach of                      developmental toxicity, toxicity to the                II. Overview of TCE and the Use Subject
                                                      prohibiting the manufacture (including                  kidney, immunotoxicity, reproductive                   to This Proposed Rule
                                                      import), processing, and distribution in                and endocrine effects, neurotoxicity,                  A. What chemical is included in the
                                                      commerce of TCE for use in vapor                        and toxicity to the liver (Ref. 2). Some               proposed rule?
                                                      degreasing; prohibiting the commercial                  of the effects that can be caused by
                                                      use of TCE in vapor degreasing; and                     exposure to TCE, such as cardiac                         This proposed rule applies to TCE
                                                      requiring manufacturers, processors,                    malformations and fetal death, occur in                (Chemical Abstract Services Registry
                                                      and distributors, except for retailers, to              utero and can impact a person for a                    Number 79–01–6) for use in vapor
                                                      provide downstream notification of                      lifetime; other effects, such as damage to             degreasing.
                                                      these prohibitions throughout the                       the developing immune system, may                      B. What are the uses of TCE?
                                                      supply chain as well as associated                      first manifest when a person is an adult
                                                      recordkeeping requirements. This                        and can have long lasting impacts. Also                   In 2011, global consumption of TCE
                                                      analysis (Ref. 3), which is available in                see Unit VI.D.                                         was 945 million pounds and
                                                      the docket, is discussed in Unit VI., and                                                                      consumption in the United States was
                                                      is briefly summarized here.                             F. Children’s Environmental Health                     255 million pounds. TCE is produced
                                                         Alternatives to TCE with similar                        This action is consistent with the                  within and imported into the United
                                                      performance characteristics are readily                 1995 EPA Policy on Evaluating Health                   States. Nine companies, including
                                                      available. Most of the costs of the rule                Risks to Children (http://www.epa.gov/                 domestic manufacturers and importers,
                                                      would be borne by commercial users of                   children/epas-policy-evaluating-risk-                  reported a total production and import
                                                      TCE in vapor degreasing equipment,                      children). EPA has identified women of                 of 225 million pounds of TCE in 2011
                                                      because they would have to switch                       childbearing age and the developing                    to EPA pursuant to the Chemical Data
                                                      solvents and likely equipment as well.                  fetus as a susceptible subpopulation                   Reporting (CDR) rule (Ref. 2).
                                                      EPA has estimated that the costs to                     relevant to its risk assessment for TCE.                  The majority (about 83.6%) of TCE is
                                                      users range from $30M to $45M when                      After evaluating the developmental                     used as an intermediate chemical for
                                                      annualized over 20 years at a 3%                        toxicity literature for TCE, the Integrated            manufacturing refrigerant HFC-134a.
                                                      discount rate, and from $32M to $46M                    Risk Information System (IRIS) TCE                     This use occurs in a closed system that
                                                      over 20 years at a 7% discount rate.                    assessment concluded that fetal heart                  has low potential for human exposure
                                                      These are the total estimated costs of                  malformations are the most sensitive                   (Ref. 2). EPA did not assess this use and
                                                      this proposal. The costs of the                         developmental toxicity endpoint                        is not proposing to regulate this use of
                                                      downstream notification and                             associated with TCE inhalation                         TCE under TSCA at this time. However,
                                                      recordkeeping requirements to                           exposure (Ref. 4). In its TSCA Chemical                this does not mean that EPA found that
                                                      manufacturers, processors, and                          Work Plan Risk Assessment for TCE,                     this use or other uses not included in
                                                      distributors of TCE, estimated to be                    EPA identified developmental toxicity                  the TCE risk assessment present low
                                                      approximately $3,200 and $4,400                         as the most sensitive endpoint for TCE                 risk. Much of the remainder, about
                                                      annualized over 20 years using 3% and                   inhalation exposure (i.e., fetal heart                 14.7%, is used as a solvent for
                                                      7% discount rates respectively. For                     malformations) for the most sensitive                  degreasing of metals. A relatively small
                                                      additional information see Unit 5.1.3 of                human life stage (i.e., women of                       percentage, about 1.7%, accounts for all
                                                      the Economic Analysis. (Ref. 3)                         childbearing age between the ages of 16                other uses, including TCE use in
                                                      However, because these notification and                 and 49 years and the developing fetus)                 products, such as aerosol degreasers.
                                                      recordkeeping costs were already                        (Ref. 2). EPA used developmental                          Based on the Toxics Release Inventory
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                                                      accounted for in the economic analysis                  toxicity endpoints for both the acute                  (TRI) data for 2012, 38 companies used
                                                      accompanying the earlier TCE proposal                   and chronic non-cancer risk                            TCE as a formulation component, 33
                                                      (Ref. 1), they are not included in the                  assessments based on its developmental                 companies processed TCE by
                                                      total costs for this proposal. EPA                      toxicity risk assessment policy that a                 repackaging the chemical, 28 companies
                                                      accounted for these costs in the prior                  single exposure of a chemical within a                 used TCE as a manufacturing aid, and
                                                      proposal because it believes the                        critical window of fetal development                   1,113 companies used TCE for ancillary
                                                      universe of entities distributing TCE for               may produce adverse developmental                      uses, such as degreasing (Ref. 2). Based
                                                      both sets of uses are the same. EPA is                  effects (Ref. 5). For the identified                   on the latest TRI data from 2014, the
                                                      taking comment on whether the same                      susceptible subpopulations, the                        number of users of TCE has significantly


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                           7435

                                                      decreased since 2012: 24 companies use                  implantation loss, resorptions);                       to a lesser extent other metabolites,
                                                      TCE as a formulation component, 20                      decreased growth (low birth weight,                    appears to be responsible for kidney
                                                      companies process TCE by repackaging                    small for gestational age); congenital                 damage and kidney cancer following
                                                      the chemical, 20 companies use TCE as                   malformations, in particular heart                     TCE exposure. Toxicokinetic data
                                                      a manufacturing aid, and 97 companies                   defects; and postnatal effects such as                 suggest that the TCE metabolites derived
                                                      use TCE for ancillary uses, such as                     reduced growth, decreased survival,                    from glutathione conjugation (in
                                                      degreasing. The TRI data does not                       developmental neurotoxicity,                           particular DCVC) can be systemically
                                                      represent all of the facilities                         developmental immunotoxicity, and                      delivered or formed in the kidney.
                                                      manufacturing, processing, and/or using                 childhood cancers. Some                                Moreover, DCVC-treated animals
                                                      TCE because only certain industries and                 epidemiological studies reported an                    showed the same type of kidney damage
                                                      types of facilities are required to report.             increased incidence of birth defects in                as those treated with TCE (Ref. 2). The
                                                      EPA estimates that there are 2,632 to                   TCE-exposed populations from                           toxicokinetic data and the genotoxicity
                                                      6,232 firms using TCE for vapor                         exposure to contaminated water. As for                 of DCVC further suggest that a
                                                      degreasing in the U.S. (Ref. 3).                        human developmental neurotoxicity,                     mutagenic mode of action is involved in
                                                        The use assessed by EPA that is the                   studies collectively suggest that the                  TCE-induced kidney tumors, although
                                                      subject of this proposal, commercial use                developing brain is susceptible to TCE                 cytotoxicity followed by compensatory
                                                      of TCE in vapor degreasing, is estimated                toxicity. These studies have reported an               cellular proliferation cannot be ruled
                                                      to represent up to 14.7% of total use of                association with TCE exposure and                      out. As for the mutagenic mode of
                                                      TCE. This use is discussed in detail in                 central nervous system birth defects and               action, both genetic polymorphisms
                                                      Unit VI.                                                postnatal effects such as delayed                      (Glutathione transferase (GST) pathway)
                                                      C. What are the potential health effects                newborn reflexes, impaired learning or                 and mutations to tumor suppressor
                                                      of TCE?                                                 memory, aggressive behavior, hearing                   genes have been hypothesized as
                                                                                                              impairment, speech impairment,                         possible mechanistic key events in the
                                                         A broad set of relevant studies                      encephalopathy, impaired executive                     formation of kidney cancers in humans
                                                      including epidemiologic studies, animal                 and motor function and attention deficit               (Ref. 2).
                                                      bioassays, metabolism studies, and                      disorder (Ref. 2).                                        The toxicological literature provides
                                                      mechanistic studies show that TCE                          Immune-related effects following TCE                support for male and female
                                                      exposure is associated with an array of                 exposures have been observed in adult                  reproductive effects following TCE
                                                      adverse health effects. TCE has the                     animal and human studies. In general,                  exposure. Both the epidemiological and
                                                      potential to induce developmental                       these effects were associated with                     animal studies provide evidence of
                                                      toxicity, immunotoxicity, kidney                        enhanced immune response as opposed                    adverse effects to female reproductive
                                                      toxicity, reproductive and endocrine                    to immunosuppressive effects. Human                    outcomes. However, more extensive
                                                      effects, neurotoxicity, liver toxicity, and             studies have reported a relationship                   evidence exists in support of an
                                                      several forms of cancer (Ref. 2).                       between systemic autoimmune diseases,                  association between TCE exposures and
                                                         TCE is fat soluble (lipophilic) and                  such as scleroderma, with occupational                 male reproductive toxicity. There is
                                                      easily crosses biological membranes.                    exposure to TCE. There have also been                  evidence that metabolism of TCE in
                                                      TCE has been found in human maternal                    a large number of case reports in                      male reproductive tract tissues is
                                                      and fetal blood and in the breast milk                  TCE-exposed workers developing a                       associated with adverse effects on sperm
                                                      of lactating women (Ref. 2). EPA’s IRIS                 severe hypersensitivity skin disorder,                 measures in both humans and animals.
                                                      assessment (Ref. 4) concluded that TCE                  often accompanied by systemic effects                  Furthermore, human studies support an
                                                      poses a potential health hazard for non-                to the lymph nodes and other organs,                   association between TCE exposure and
                                                      cancer toxicity including fetal heart                   such as hepatitis (Ref. 2).                            alterations in sperm density and quality,
                                                      malformations and other developmental                      Studies in both humans and animals                  as well as changes in sexual drive or
                                                      effects, immunotoxicity, kidney toxicity,               have shown changes in the proximal                     function and altered serum endocrine
                                                      reproductive and endocrine effects,                     tubules of the kidney following                        levels (Ref. 2).
                                                      neurotoxicity, and liver effects. The IRIS              exposure to TCE (Ref. 2). The IRIS TCE                    Neurotoxicity has been demonstrated
                                                      assessment also evaluated TCE and its                   assessment concluded that TCE is                       in animal and human studies under
                                                      metabolites. Based on the results of in                 carcinogenic to humans based on                        both acute and chronic exposure
                                                      vitro and in vivo tests, TCE metabolites                convincing evidence of a causal                        conditions. Evaluation of multiple
                                                      have the potential to bind or induce                    relationship between TCE exposure in                   human studies revealed TCE-induced
                                                      damage to the structure of                              humans and kidney cancer (Ref. 4). A                   neurotoxic effects including alterations
                                                      deoxyribonucleic acid (DNA) or                          recent review of TCE by the                            in trigeminal nerve and vestibular
                                                      chromosomes (Ref. 4).                                   International Agency for Research on                   function, auditory effects, changes in
                                                         An evaluation of the overall weight of               Cancer (IARC) also supported this                      vision, alterations in cognitive function,
                                                      the evidence of the human and animal                    conclusion (Ref. 7). The 12th report on                changes in psychomotor effects, and
                                                      developmental toxicity data suggests an                 carcinogens (RoC) by the National                      neurodevelopmental outcomes. These
                                                      association between pre- and/or post-                   Toxicology Program also concluded that                 studies in different populations have
                                                      natal TCE exposures and potential                       TCE is reasonably anticipated to be a                  consistently reported vestibular
                                                      adverse developmental outcomes.                         human carcinogen 2015 (Ref. 8). These                  system-related symptoms such as
                                                      TCE-induced heart malformations and                     additional recent peer reviews are                     headaches, dizziness, and nausea
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                                                      immunotoxicity in animals have been                     consistent with EPA’s classification that              following TCE exposure (Ref. 2).
                                                      identified as the most sensitive                        TCE is carcinogenic to humans by all                      Animals and humans exposed to TCE
                                                      developmental toxicity endpoints for                    routes of exposures based upon strong                  consistently experience liver toxicity.
                                                      TCE. Human studies examined the                         epidemiological and animal evidence                    Specific effects include the following
                                                      possible association of TCE with various                (Refs. 2, 4).                                          structural changes: Increased liver
                                                      prenatal effects. These adverse effects of                 TCE metabolites appear to be the                    weight, increased DNA synthesis
                                                      developmental TCE exposure may                          causative agents that induce renal                     (transient), enlarged hepatocytes,
                                                      include: Death (spontaneous abortion,                   toxicity, including cancer.                            enlarged nuclei, and peroxisome
                                                      perinatal death, pre- or post-                          S-dichlorovinyl-L-cysteine (DCVC), and                 proliferation. Several human studies


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                                                      7436                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      reported an association between TCE                     rapidly when released to soil; however,                degradation rates have been reported
                                                      exposure and significant changes in                     where it is released onto land surface or              (ranging from days to years). TCE is not
                                                      serum liver function tests used in                      directly into the subsurface, TCE can                  expected to bioconcentrate in aquatic
                                                      diagnosing liver disease, or changes in                 migrate from soil to groundwater. Based                organisms based on measured
                                                      plasma or serum bile acids. There was                   on TCE’s moderate persistence, low                     bioconcentration factors of less than
                                                      also human evidence for hepatitis                       bioaccumulation, and low hazard for                    1000 (Ref. 2).
                                                      accompanying immune-related                             aquatic toxicity, the magnitude of
                                                                                                                                                                     III. Regulatory Actions Pertaining to
                                                      generalized skin diseases, jaundice,                    potential environmental impacts on
                                                                                                                                                                     TCE
                                                      hepatomegaly, hepatosplenomegaly, and                   ecological receptors is judged to be low
                                                      liver failure in TCE-exposed workers                    for the environmental releases                            Because of its potential health effects,
                                                      (Ref. 2).                                               associated with the use of TCE for vapor               TCE is subject to state, federal, and
                                                         TCE is characterized as carcinogenic                 degreasing. This should not be                         international regulations restricting and
                                                      to humans by all routes of exposure as                  misinterpreted to mean that the fate and               regulating its use, which are
                                                      documented in EPA’s IRIS TCE                            transport properties of TCE suggest that               summarized in this unit. None of these
                                                      assessment (Ref. 4). This conclusion is                 water and soil contamination is likely                 actions addresses the unreasonable risks
                                                      based on strong cancer epidemiological                  low or does not pose an environmental                  under TSCA that EPA is seeking to
                                                      data that reported an association                       concern. EPA is addressing TCE                         address in this proposed rule.
                                                      between TCE exposure and the onset of                   contamination in groundwater, drinking                 A. Federal Actions Pertaining to TCE
                                                      various cancers, primarily in the kidney,               water, and contaminated soils at a large
                                                      liver, and the immune system, i.e.,                     number of sites. While the primary                        Since 1979, EPA has issued numerous
                                                      non-Hodgkin’s lymphoma (NHL).                           concern with this contamination has                    rules and notices pertaining to TCE
                                                      Further support for TCE’s                               been human health, there is potential                  under its various authorities.
                                                      characterization as a carcinogen comes                  for TCE exposures to ecological                           • Toxic Substances Control Act: On
                                                      from positive results in multiple rodent                receptors in some cases (Ref. 2).                      December 16, 2016, EPA issued a
                                                      cancer bioassays in rats and mice of                       2. What is the global warming                       proposed rule under TSCA section 6 to
                                                      both sexes, similar toxicokinetics                      potential of TCE? Global warming                       prohibit the manufacture (including
                                                      between rodents and humans,                             potential (GWP) measures the potency                   import), processing, distribution in
                                                      mechanistic data supporting a                           of a greenhouse gas over a specific                    commerce and commercial use of TCE
                                                      mutagenic mode of action for kidney                     period of time, relative to carbon                     in aerosol degreasers and as a spot
                                                      tumors, and the lack of mechanistic data                dioxide, which has a high GWP of 1                     removal agent in dry cleaning facilities
                                                      supporting the conclusion that any of                   regardless of the time period used. Due                (Ref. 1). In addition, EPA published a
                                                      the mode(s) of action for TCE-induced                   to high variability in the atmospheric                 final Significant New Use Rule (SNUR)
                                                      rodent tumors are irrelevant to humans.                 lifetime of greenhouse gases, the 100-                 that would require manufacturers
                                                      Additional support comes from the 2014                  year scale (GWP100) is typically used.                 (including importers) and processors of
                                                      evaluation of TCE’s carcinogenic effects                TCE has relatively low global warming                  TCE to notify the Agency before starting
                                                      by IARC, which classifies TCE as                        potential at a GWP100 of 140 and thus                  or resuming any significant new uses of
                                                      carcinogenic to humans (Ref. 7). The                    the impact is low (Ref. 2).                            TCE in certain consumer products,
                                                      12th NTP RoC also concluded that TCE                       3. What is the ozone depletion                      including in spray fixatives used to
                                                      exposure is reasonably anticipated to be                potential of TCE? TCE is not an ozone-                 finish arts and crafts (81 FR 20535,
                                                      a human carcinogen (Ref. 8). These                      depleting substance and is listed as                   April 8, 2016) (Ref. 10).
                                                      additional recent peer reviewed                         acceptable under the Significant New                      • Safe Drinking Water Act: EPA has
                                                      documents are consistent with EPA’s                     Alternatives Policy (SNAP) program for                 issued drinking water standards for TCE
                                                      classification that TCE is carcinogenic to              degreasing and aerosols. In 2007, TCE                  pursuant to section 1412 of the Safe
                                                      humans by all routes of exposures based                 was identified as a substitute for two                 Drinking Water Act. EPA promulgated
                                                      upon strong epidemiological and animal                  ozone depleting chemicals, methyl                      the National Primary Drinking Water
                                                      evidence (Refs. 2, 4).                                  chloroform and CFC–113, for metals,                    Regulation (NPDWR) for TCE in 1987
                                                                                                              electronics, and precision cleaning (72                (52 FR 25690, July 8, 1987). The
                                                      D. What are the environmental impacts                   FR 30142, May 30, 2007) (FRL–8316–8)                   NPDWR established a non-enforceable
                                                      of TCE?                                                 (Ref. 9).                                              maximum contaminant level (MCL) goal
                                                        Pursuant to TSCA section 6(c), this                      4. Is TCE a volatile organic compound               of zero milligrams per liter (mg/L) based
                                                      unit describes the effects of TCE on the                (VOC)? TCE is a VOC as defined at 40                   on classification as a probable human
                                                      environment and the magnitude of the                    CFR 51.100(c). A VOC is any compound                   carcinogen. The NPDWR also
                                                      exposure of the environment to TCE.                     of carbon, excluding carbon monoxide,                  established an enforceable MCL of 0.005
                                                      The unreasonable risk determination of                  carbon dioxide, carbonic acid, metallic                mg/L. EPA is evaluating revising the
                                                      this proposal is based solely on risks to               carbides or carbonates, and ammonium                   TCE drinking water standard as part of
                                                      human health since those risks are the                  carbonate, which participates in                       a group of carcinogenic volatile organic
                                                      most serious consequence of use of TCE                  atmospheric photochemical reactions.                   compounds.
                                                      and are sufficient to support this                         5. Does TCE persist in the                             • Clean Water Act: EPA identified
                                                      proposed action. The following is a                     environment and bioaccumulate? TCE                     TCE as a toxic pollutant under section
                                                      discussion of the environmental impacts                 may be persistent, but it is not                       307(a)(1) of the Clean Water Act (33
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                                                      of TCE.                                                 bioaccumulative. TCE is slowly                         U.S.C. 1317(a)(1)) in 1979 (44 FR 44502,
                                                        1. Environmental effects and impacts.                 degraded by sunlight and reactants                     July 30, 1979) (FRL–1260–5). In
                                                      TCE enters the environment as a result                  when released to the atmosphere.                       addition, EPA developed recommended
                                                      of emissions from metal degreasing                      Volatilization and microbial                           TCE ambient water quality criteria for
                                                      facilities, and spills or accidental                    biodegradation influence the fate of TCE               the protection of human health pursuant
                                                      releases, and historic waste disposal                   when released to water, sediment or                    to section 304(a) of the Clean Water Act.
                                                      activities. Because of its high vapor                   soil. The biodegradation of TCE in the                    • Clean Air Act: TCE is a hazardous
                                                      pressure and low affinity for organic                   environment is dependent on a variety                  air pollutant (HAP) under the Clean Air
                                                      matter in soil, TCE evaporates fairly                   of factors and so a wide range of                      Act (42 U.S.C. 7412(b)(1). EPA


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                             7437

                                                      promulgated National Emission                           hazardous waste subject to Subtitle C of               B. State Actions Pertaining to TCE
                                                      Standards for Hazardous Air Pollutants                  RCRA pursuant to the toxicity                             Many states have taken actions to
                                                      (NESHAPs) for TCE for several                           characteristics or as a listed waste.                  reduce risks from TCE use. TCE is listed
                                                      industrial source categories, including                 RCRA also provides authority to require                on California’s Safer Consumer Products
                                                      halogenated solvent cleaning, fabric                    cleanup of hazardous wastes containing                 regulations candidate list of chemicals
                                                      printing, coating, and dyeing, and                      TCE at RCRA facilities.                                that exhibit a hazard trait and are on an
                                                      synthetic organic chemical                                 • Comprehensive Environmental
                                                                                                                                                                     authoritative list and is also listed on
                                                      manufacturing. The halogenated solvent                  Response, Compensation and Liability
                                                                                                                                                                     California’s Proposition 65 list of
                                                      cleaning NESHAP, controls emissions of                  Act (CERCLA): EPA designated TCE as
                                                                                                                                                                     chemicals known to cause cancer or
                                                      several halogenated solvents, including                 a hazardous substance with a reportable
                                                                                                                                                                     birth defects or other reproductive
                                                      TCE, from halogenated solvent cleaning                  quantity pursuant to section 102(a) of
                                                                                                                                                                     harm. In addition, the California Code of
                                                      machines (40 CFR subpart T). The                        CERCLA and EPA is actively overseeing
                                                                                                              cleanup of sites contaminated with TCE                 Regulations, Title 17, Section 94509(a)
                                                      NESHAP includes multiple compliance                                                                            lists standards for VOCs for consumer
                                                      alternatives to allow maximum                           pursuant to the National Contingency
                                                                                                              Plan (NCP). While many of the statutes                 products sold, supplied, offered for sale,
                                                      compliance flexibility. In 2007, EPA                                                                           or manufactured for use in California
                                                      promulgated the Halogenated Solvent                     that EPA is charged with administering
                                                                                                              provide statutory authority to address                 (Ref. 15). As part of that regulation, use
                                                      Cleaning NESHAP RTR (Risk and                                                                                  of consumer general purpose degreaser
                                                      Technology Review) Rule (72 FR 25138,                   specific sources and routes of TCE
                                                                                                              exposure, none of these can address the                products that contain TCE are banned in
                                                      May 3, 2007) (FRL–8303–6), in which                                                                            California and safer substitutes are in
                                                      EPA evaluated the health and                            serious human health risks from TCE
                                                                                                              exposure that EPA is proposing to                      use.
                                                      environmental risks remaining after                                                                               In Massachusetts, TCE is a designated
                                                      promulgation of the original NESHAP                     address under TSCA section 6(a) with
                                                                                                              this proposed rule.                                    high hazard substance, with an annual
                                                      and established revised standards that                                                                         reporting threshold of 1,000 pounds
                                                      further limit emissions of TCE (and                        The Occupational Safety and Health
                                                                                                              Administration (OSHA) established a                    (Ref. 16). Minnesota classifies TCE as a
                                                      other solvents) in halogenated solvent                                                                         chemical of high concern (Ref. 17).
                                                      cleaning. Specifically, EPA promulgated                 permissible exposure limit (PEL) for
                                                                                                              TCE in 1971. The PEL is an 8-hour time-                Many other states have considered TCE
                                                      a facility-wide emission limit of 60,000                                                                       for similar chemical listings (Ref. 18).
                                                      kilograms per year (kg/year) methylene                  weighted average (TWA) TCE
                                                                                                              concentration of 100 ppm. In addition,                 Several additional states have various
                                                      chloride equivalent, a unit which                                                                              TCE regulations that range from
                                                      combines emissions of methylene                         the TCE PEL requires that exposure to
                                                                                                              TCE not exceed 200 ppm (ceiling) at any                reporting requirements to product
                                                      chloride, trichloroethylene, and                                                                               contamination limits to use reduction
                                                                                                              time during an eight hour work shift
                                                      perchloroethylene. The facility-wide                                                                           efforts aimed at limiting or prohibiting
                                                                                                              with the following exception: Exposures
                                                      emission limit applied to all                                                                                  TCE content in products.
                                                                                                              may exceed 200 ppm, but not more than
                                                      halogenated solvent cleaning machines                                                                             Most states have set PELs identical to
                                                                                                              300 ppm (peak), for a single time period
                                                      with the exception of halogenated                                                                              the OSHA 100 ppm 8-hour TWA PEL
                                                                                                              up to 5 minutes in any 2 hours (Ref. 11).
                                                      solvent cleaning machines used by the                                                                          (Ref. 18). Nine states have PELs of 50
                                                                                                              OSHA acknowledges that many of its
                                                      following industries: Facilities that                                                                          ppm (Ref. 18). California’s PEL of 25
                                                                                                              PELs are not sufficiently protective of
                                                      manufacture narrow tubing, facilities                                                                          ppm is the most stringent (Ref. 15). All
                                                                                                              worker health. OSHA has noted that
                                                      that use continuous web cleaning                                                                               of these PELs are significantly higher
                                                                                                              ‘‘with few exceptions, OSHA’s PELs,
                                                      machines, aerospace manufacturing and                                                                          than the exposure levels at which EPA
                                                                                                              which specify the amount of a particular
                                                      maintenance facilities, and military                    chemical substance allowed in                          identified unreasonable risks for TCE
                                                      maintenance and depot facilities. EPA                   workplace air, have not been updated                   use for vapor degreasing and would not
                                                      also promulgated a facility-wide                        since they were established in 1971                    be protective.
                                                      emission limit of 100,000 kg/year                       under expedited procedures available in
                                                      methylene chloride equivalent for                                                                              C. International Actions Pertaining to
                                                                                                              the short period after the OSH Act’s                   TCE
                                                      halogenated solvent cleaning machines                   adoption . . . Yet, in many instances,
                                                      used at military maintenance and depot                  scientific evidence has accumulated                       TCE is also regulated internationally
                                                      facilities. TCE is also regulated under                 suggesting that the current limits are not             and the international industrial and
                                                      the NESHAP rule for synthetic organic                   sufficiently protective’’ (Ref. 12 at p.               commercial sectors have moved to
                                                      chemical manufacturing. This rule                       61386), including the PEL for TCE.                     alternatives. TCE was added to the EU
                                                      consists of four subparts in 40 CFR part                   To provide employers, workers, and                  Registration, Evaluation, Authorisation
                                                      63. In 2003, EPA issued a final NESHAP                  other interested parties with a list of                and Restriction of Chemicals (REACH)
                                                      rule to reduce toxic air pollutant                      alternate occupational exposure limits                 restriction of substances classified as a
                                                      emissions from fabric and other textile                 that may serve to better protect workers,              carcinogen category 1B under the EU
                                                      coating, printing, and dyeing facilities.               OSHA’s Web page highlights selected                    Classification and Labeling regulation in
                                                      The final rule applied to new and                       occupational exposure limits derived by                2009 (Ref. 19). The restriction prohibits
                                                      existing facilities that emit 10 tons per               other organizations. For example, the                  the placing on the market or use of TCE
                                                      year or more of a single toxic air                      National Institute for Occupational                    as a substance, as a constituent of other
                                                      pollutant listed in the Clean Air Act or                Safety and Health considers TCE a                      substances, or in mixtures for supply to
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                                                      25 tons per year or more of a                           potential occupational carcinogen and                  the general public when the individual
                                                      combination of those pollutants,                        recommended an exposure limit of 25                    concentration of TCE in the substance or
                                                      including TCE. In addition, EPA has                     ppm as a 10-hour TWA in 2003 (Ref.                     mixture is equal to or greater than 0.1%
                                                      established VOC standards for consumer                  13). The American Conference of                        by weight (Ref. 19). In 2010, TCE was
                                                      products under section 183(e) of the                    Governmental Industrial Hygienists                     added to the Candidate List of
                                                      Clean Air Act.                                          recommended an 8-hour TWA of 10                        substances for inclusion in Annex XIV
                                                         • Resource Conservation and                          ppm and an acute, or short term,                       of REACH, or the Authorisation List.
                                                      Recovery Act (RCRA): EPA classifies                     exposure limit of 25 ppm in 2004 (Ref.                 Annex XIV includes substances of very
                                                      certain wastes containing TCE as                        14).                                                   high concern that are subject to use


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                                                      7438                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      authorization due to their hazardous                    risk of long-term toxicity to humans or                the July 2013 peer review of the
                                                      properties. TCE meets the criteria for                  to flora and fauna in the human living                 December 2012 draft TCE risk
                                                      classification as a carcinogen. In 2011,                environment, and that have been, or in                 assessment. All documents from the
                                                      TCE was recommended for inclusion in                    the near future are reasonably likely to               July 2013 peer review of the draft TCE
                                                      Annex XIV of REACH due to the very                      be, found in considerable amounts over                 risk assessment are available in EPA
                                                      high volumes allocated to uses in the                   a substantially extensive area of the                  Docket Number EPA–HQ–OPPT–2012–
                                                      scope of authorization and because at                   environment) (Ref. 24). Japan also                     0723. TCE appears in the 2014 update
                                                      least some of the described uses                        controls air emissions and water                       of the TSCA Work Plan for Chemical
                                                      appeared to result in significant                       discharges containing TCE, as well as                  Assessments and the completed risk
                                                      exposure of workers and professionals,                  aerosol products for household use and                 assessment is noted therein. The TCE
                                                      and could be considered widely                          household cleaners containing TCE.                     risk assessment evaluated commercial
                                                      dispersive uses.                                           TCE is listed in the Australian                     and consumer use of TCE as a solvent
                                                         In 2013, the Commission added TCE                    National Pollutant Inventory, a program                degreaser (aerosol degreasing and vapor
                                                      to Annex XIV of REACH, making it                        run cooperatively by the Australian,                   degreasing), commercial use of TCE as
                                                      subject to authorization. As such,                      State and Territory governments to                     a spotting agent at dry cleaning
                                                      entities that wanted to use TCE were                    monitor common pollutants and their                    facilities, and consumer use of TCE as
                                                      required to apply for authorization by                  levels of release to the environment.                  a spray-applied protective coating for
                                                      October 2014, and those entities without                Australia classifies TCE as a health,                  arts and crafts (Ref. 2).
                                                      an authorization were required to stop                  physicochemical and/or                                    The uses selected for the TCE risk
                                                      using TCE by April 2016. The European                   ecotoxicological hazard, according to                  assessment were chosen because they
                                                      Chemicals Agency (ECHA) received 19                     the Australian National Occupational                   were expected to involve frequent or
                                                      applications for authorization from                     Health and Safety Commission (Ref. 25).                routine use of TCE in high
                                                      entities interested in using TCE beyond                                                                        concentrations and/or have high
                                                      April 2016. Two of those were for vapor                 IV. TCE Risk Assessment                                potential for human exposure (Ref. 2).
                                                      degreasing applications (Refs. 20, 21). In                 In 2013, EPA identified TCE use as a                However, this does not mean that EPA
                                                      each case, the opinion of the Committee                 solvent degreaser (aerosol degreasing                  found that other uses not included in
                                                      for Risk Assessment was that it was not                 and vapor degreasing) and spot remover                 the TCE risk assessment present low
                                                      possible to determine a derived no-                     in dry cleaning operations as a priority               risk.
                                                      effect level (DNEL) for the                             for risk assessment under the TSCA                        As described in the TCE risk
                                                      carcinogenicity properties of the                       Work Plan. This Unit describes the                     assessment, solvent cleaning or
                                                      substance in accordance with REACH                      development of the TCE risk assessment                 degreasing is widely used to remove
                                                      and that the operational conditions and                 and supporting analysis and expert                     grease, oils, waxes, carbon deposits,
                                                      risk management measures in the                         input on vapor degreasing, the use that                fluxes, and tars from metal, glass, or
                                                      applications appeared not to limit the                  is the subject of this proposed rule. A                plastic surfaces. With respect to vapor
                                                      risk. Those measures included use in a                  more detailed discussion of the risks                  degreasing, there are two general types
                                                      specific type of closed vapor degreasing                associated with TCE use in vapor                       of degreasing machines: Batch and
                                                      system with personal protective                         degreasing can be found in Unit VI.                    in-line. Batch cleaning machines are the
                                                      equipment (PPE). Final decisions have                                                                          most common type, while in-line
                                                      not yet been made on the applications.                  A. TSCA Work Plan for Chemical                         cleaners are typically used in large-scale
                                                         Canada conducted a hazard                            Assessments                                            industrial operations. There are a
                                                      assessment of TCE in 1993 and                             In 2012, EPA released the TSCA Work                  number of variations of each general
                                                      concluded that ‘‘trichloroethylene                      Plan Chemicals: Methods Document in                    type of machine. Emissions from
                                                      occurs at concentrations that may be                    which EPA described the process the                    degreasing machines typically result
                                                      harmful to the environment, and that                    Agency intended to use to identify                     from:
                                                      may constitute a danger in Canada to                    potential candidate chemicals for near-                   • Evaporation of the solvent from the
                                                      human life or health. It has been                       term review and assessment under                       interface between the solvent and the
                                                      concluded that trichloroethylene occurs                 TSCA (Ref. 26). EPA also released the                  air,
                                                      at concentrations that do not constitute                initial list of TSCA Work Plan chemicals                  • ‘‘Carry out’’ of excess solvent on
                                                      a danger to the environment on which                    identified for further assessment under                cleaned parts, and
                                                      human life depends’’ (Ref. 22). In 2003,                TSCA as part of its chemical safety                       • Evaporative losses of the solvent
                                                      Canada issued the Solvent Degreasing                    program (Ref. 27).                                     during filling and draining of the
                                                      Regulations (SOR/2003–283) to reduce                      The process for identifying these                    degreasing machine.
                                                      releases of TCE into the environment                    chemicals for further assessment under                    In its assessment of vapor degreasing,
                                                      from solvent degreasing facilities using                TSCA was based on a combination of                     the TCE risk assessment concentrated
                                                      more than 1,000 kilograms of TCE per                    hazard, exposure, and persistence and                  on open top vapor degreasing machines
                                                      year (Ref. 23). In 2013, Canada added                   bioaccumulation characteristics, and is                because they are the most prevalent,
                                                      TCE to the Toxic Substances List—                       described in the TSCA Work Plan                        particularly for smaller operations. The
                                                      Schedule 1 because TCE ‘‘is entering or                 Chemicals Methods Document (Ref. 26).                  risk assessment identified acute and
                                                      may enter the environment in a quantity                 Using the TSCA Work Plan chemical                      chronic non-cancer risks for workers
                                                      or concentration or under conditions                    prioritization criteria, TCE ranked high               who conduct TCE-based solvent vapor
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                                                      that: (a) Have or may have an immediate                 for health hazards and exposure                        degreasing at small degreasing facilities,
                                                      or chronic harmful effect on the                        potential and was included on the                      as well as occupational bystanders to
                                                      environment or its biological diversity,                initial list of TSCA Work Plan chemicals               those activities. More specifically, the
                                                      and (c) constitute or may constitute a                  for assessment.                                        TCE risk assessment identified risks for
                                                      danger in Canada to human life or                                                                              non-cancer developmental effects
                                                      health.’’ (Ref. 23).                                    B. TCE Risk Assessment                                 resulting from acute exposure. The risk
                                                         In Japan, the Chemical Substances                       EPA finalized a TSCA Work Plan                      assessment also identified risks for a
                                                      Control Law considers TCE a Class II                    Chemical Risk Assessment for TCE (TCE                  range of non-cancer health effects
                                                      substance (substances that may pose a                   risk assessment) in June 2014, following               resulting from chronic exposure. Within


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                            7439

                                                      this range of effects, the greatest risk is             risk assessment used the                               parts, availability and efficacy of safer
                                                      for developmental effects (i.e., fetal                  physiologically-based pharmacokinetic                  alternatives, safer engineering practices
                                                      cardiac defects), although there also are               (PBPK)-derived hazard values (HEC50,                   and technologies to reduce exposure to
                                                      risks for kidney effects and                            HEC95, or HEC99; HECXX is the Human                    TCE, and to discuss possible risk
                                                      immunotoxicity. In addition, there are                  Equivalent Concentration at a particular               reduction approaches. The workshop
                                                      risks for adverse reproductive effects,                 percentile) from the Johnson et al.                    included presentations by experts,
                                                      neurotoxicity, and liver toxicity                       (2003) (Ref. 29) developmental toxicity                breakout sessions with case studies, and
                                                      associated with chronic exposures (Ref.                 study for each vapor degreaser use                     public comment opportunities (Ref. 31)
                                                      2).                                                     scenario. Note that the differences                    and informed EPA’s assessment of the
                                                         Margins of exposure (MOEs) were                      among these hazard values is small and                 alternatives to TCE considered in this
                                                      used in this assessment to estimate non-                no greater than 3-fold (i.e., 2-fold for               proposed rule. All documents from the
                                                      cancer risks for acute and chronic                      HEC50/HEC95 ratios; 3-fold for HEC50/                  public workshop are available in EPA
                                                      exposures. The MOE is the health point                  HEC99 ratios; 1.4-fold for HEC95/HEC99                 Docket Number EPA–HQ–OPPT–2014–
                                                      of departure (an approximation of the                   ratios). The IRIS TCE assessment used                  0327. Informed in part by the workshop
                                                      no-observed adverse effect level) for a                 the HEC99 for the non-cancer                           and other analysis, including discussion
                                                      specific endpoint divided by the                        dose-response derivations because the                  with the Toxics Use Reduction Institute
                                                      exposure concentration for the specific                 HEC99 was interpreted to be protective                 at the University of Massachusetts
                                                      scenario of concern. The benchmark                      for a sensitive individual in the                      Lowell, EPA has concluded that TCE
                                                      MOE accounts for the total uncertainty                  population (Ref. 4). While the HEC99                   alternatives are available for all
                                                      factor based on the following                           was used to find the level of risk to be               applications subject to this proposed
                                                      uncertainty factors: Intraspecies,                      used in making the proposed TSCA                       rule as well as EPA’s earlier proposal
                                                      interspecies, subchronic to chronic, and                section 6(a) determination, the small                  (Ref. 1). The discussions at the public
                                                      lowest observed adverse effect level                    variation among HEC50, HEC95 and                       workshop demonstrated that
                                                      (LOAEL) to no-observed adverse effect                   HEC99 would not result in a different                  alternatives are available for the vapor
                                                      level (NOAEL). Uncertainty factors are                  risk determination.                                    degreasing uses that are being addressed
                                                      intended to account for (1) the variation                  For non-cancer effects, EPA estimated               in this proposed rulemaking.
                                                      in sensitivity among the members of the                 exposures that are significantly greater
                                                                                                                                                                        On June 1, 2016, EPA convened a
                                                      human population (i.e., interhuman or                   than the point of departure. The
                                                                                                                                                                     Small Business Advocacy Review
                                                      intraspecies variability); (2) the                      baseline cancer risk is estimated to be
                                                                                                                                                                     (SBAR) Panel on TCE in vapor
                                                      uncertainty in extrapolating animal data                3.66 × 10¥1 for users of open top vapor
                                                                                                                                                                     degreasing. The Panel solicited input
                                                      to humans (i.e., interspecies variability);             degreasing systems.
                                                                                                                 The levels of acute and chronic                     from eighteen Small Entity
                                                      (3) the uncertainty in extrapolating from
                                                                                                              exposures estimated to present low risk                Representatives (SERs) and made
                                                      data obtained in a study with less-than-
                                                      lifetime exposure to lifetime exposure                  for non-cancer effects also result in low              several recommendations on aspects of
                                                      (i.e., extrapolating from subchronic to                 risk for cancer.                                       this rulemaking. The Panel process,
                                                      chronic exposure); and (4) the                             Given these identified risks, EPA                   including the final report of the Panel
                                                      uncertainty in extrapolating from a                     conducted an additional analysis                       (Ref. 32), is discussed in Unit XII.
                                                      LOAEL rather than from a NOAEL (Ref.                    consistent with the scope of the TCE                   V. Regulatory Approach
                                                      28). MOEs provide a non-cancer risk                     risk assessment to better characterize
                                                      profile by presenting a range of                        the risk to workers and occupational                   A. TSCA Section 6 Unreasonable Risk
                                                      estimates for different non-cancer health               bystanders from the use of TCE in batch                Analysis
                                                      effects for different exposure scenarios,               vapor degreasing machines as well as in                   Under TSCA section 6(a), if the
                                                      and are a widely recognized method for                  two different types of in-line systems                 Administrator determines that a
                                                      evaluating a range of potential non-                    (conveyor and continuous web cleaning                  chemical substance presents an
                                                      cancer health risks from exposure to a                  machines) (Ref. 30). This analysis also                unreasonable risk of injury to health or
                                                      chemical.                                               evaluated the exposure reductions that                 the environment, without consideration
                                                         The acute inhalation risk assessment                 would result from switching from an                    of costs or other non-risk factors,
                                                      used developmental toxicity data to                     open-top vapor degreasing system to a                  including an unreasonable risk to a
                                                      evaluate the acute risks for the TCE use                closed-loop vapor degreasing system.                   potentially exposed or susceptible
                                                      scenarios. As indicated in the TCE risk                 More information on the different types                subpopulation identified as relevant to
                                                      assessment, EPA’s policy supports the                   of vapor degreasing machines can be                    the Agency’s risk evaluation, under the
                                                      use of developmental studies to evaluate                found in Unit VI.A.1. In the                           conditions of use, EPA must by rule
                                                      the risks of acute exposures. This                      supplemental analysis, EPA identified                  apply one or more requirements to the
                                                      science-based policy presumes that a                    short-term and long-term non-cancer                    extent necessary so that the chemical
                                                      single exposure of a chemical at a                      and cancer risks for all types of vapor                substance no longer presents such risk.
                                                      critical window of fetal development                    degreasing machines, although the risks
                                                      may produce adverse developmental                                                                                 The TSCA section 6(a) requirements
                                                                                                              for closed-loop machines are estimated
                                                      effects (Ref. 5). This is the case with                                                                        can include one or more, or a
                                                                                                              to be lower than for any of the other
                                                      cardiac malformation. EPA reviewed                                                                             combination of, the following actions:
                                                                                                              types (Ref. 30).
                                                      multiple studies for suitability for acute                                                                        • Prohibit or otherwise restrict the
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                                                      risk estimation including a number of                   C. Stakeholder Input on TCE and Vapor                  manufacturing, processing, or
                                                      developmental studies of TCE exposure                   Degreasing                                             distribution in commerce of such
                                                      and additional developmental studies of                   On July 29, 2014, EPA held a 2-day                   substances (§ 6(a)(1)).
                                                      TCE metabolites (Appendix N) (Ref. 2).                  public workshop on TCE degreasing                         • Prohibit or otherwise restrict
                                                      EPA based its acute risk assessment on                  (Ref. 31). The purpose of the workshop                 manufacturing, processing, or
                                                      the most sensitive health endpoint (i.e.,               was to collect information from users,                 distribution in commerce of such
                                                      fetal heart malformations) representing                 academics, and other stakeholders on                   substances for particular uses or for uses
                                                      the most sensitive human life stage (i.e.,              the use of TCE as a degreaser in various               in excess of a specified concentration
                                                      the developing fetus) (Ref. 2). The acute               applications, e.g., in degreasing metal                (§ 6(a)(2)).


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                                                      7440                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                         • Require minimum warning labels                        • Health effects of the chemical                       EPA considered the estimated costs to
                                                      and instructions (§ 6(a)(3)).                           substance or mixture (in this case, TCE)               regulated entities as well as the cost to
                                                         • Require record keeping or testing                  and the magnitude of human exposure                    administer and enforce the options. For
                                                      (§ 6(a)(4)).                                            to TCE;                                                example, an option that includes use of
                                                         • Prohibit or regulate any manner or                    • Environmental effects of TCE and                  a respirator would include inspections
                                                      method of commercial use (§ 6(a)(5)).                   the magnitude of exposure of the                       to evaluate compliance with all
                                                         • Prohibit or otherwise regulate any                 environment to TCE;                                    elements of a respiratory protection
                                                      manner or method of disposal (§ 6(a)(6)).                  • Benefits of TCE for various uses;                 program. EPA took into account
                                                                                                                 • Reasonably ascertainable economic                 reasonably available information about
                                                         • Direct manufacturers and
                                                                                                              consequences of the rule, including: The               the functionality and performance
                                                      processors to give notice of the
                                                                                                              likely effect of the rule on the national              efficacy of the regulatory options and
                                                      determination to distributors and the
                                                                                                              economy, small business, technological                 the ability to implement the use of
                                                      public and replace or repurchase
                                                                                                              innovation, the environment, and public                chemical substitutes or other
                                                      substances (§ 6(a)(7)).
                                                                                                              health; the costs and benefits of the                  alternatives (e.g., PPE). Reasonably
                                                         EPA analyzed a wide range of                         proposed and final rule and of the one
                                                      regulatory options under TSCA section                                                                          available information included the
                                                                                                              or more primary alternatives that EPA                  existence of other Federal, state, or
                                                      6(a) in order to select the proposed                    considered; and the cost effectiveness of
                                                      regulatory approach. EPA considered                                                                            international regulatory requirements
                                                                                                              the proposed rule and of the one or                    associated with each of the regulatory
                                                      whether a regulatory option (or                         more primary alternatives that EPA
                                                      combination of options) would address                                                                          options as well as the commercial
                                                                                                              considered.                                            history for the options. A discussion of
                                                      the identified unreasonable risks so that                  In addition, in selecting among
                                                      the chemical substance no longer                                                                               the costs EPA considered can be found
                                                                                                              prohibitions and other restrictions                    in Units VI.E. and VII, along with a
                                                      presents such risks. To do so, EPA                      available under TSCA section 6(a), EPA
                                                      initially analyzed whether the                                                                                 discussion of the cost effectiveness of
                                                                                                              must factor in, to the extent practicable,             the proposal and the alternatives that
                                                      regulatory options could reduce risks                   these considerations. Further, in                      EPA considered. In addition, a
                                                      (non-cancer and cancer) to levels below                 deciding whether to prohibit or restrict               discussion of the impacts on small
                                                      those of concern, based on EPA’s                        in a manner that substantially prevents                businesses can be found in Unit XII.C.
                                                      technical analysis of exposure scenarios.               a specific condition of use of a chemical                 With respect to the anticipated effects
                                                      For the non-cancer risks, EPA found an                  substance or mixture, and in setting an                of this proposal on the national
                                                      option could be protective against the                  appropriate transition period for such                 economy, EPA considered the number
                                                      risk if it could achieve the benchmark                  action, EPA must also consider, to the                 of businesses and workers that would be
                                                      MOE for the most sensitive non-cancer                   extent practicable, whether technically                affected and the costs and benefits to
                                                      endpoint. EPA’s assessments for these                   and economically feasible alternatives                 those businesses and workers. In
                                                      uses indicate that when exposures meet                  that benefit health or the environment                 addition, EPA considered the
                                                      the benchmark MOE for the most                          will be reasonably available as a                      employment impacts of this proposal, as
                                                      sensitive endpoint, they also result in                 substitute when the proposed                           discussed in the economic analysis for
                                                      low risk for cancer.                                    prohibition or other restriction takes                 this proposal (Ref. 3). EPA found that
                                                         After the technical analysis, which                  effect.                                                the direction of change in employment
                                                      represents EPA’s assessment of the                         EPA’s analysis of the health effects of             is uncertain, but the expected short term
                                                      potential for the regulatory options to                 and magnitude of exposure to TCE can                   and longer term employment effects are
                                                      achieve risk benchmarks based on                        be found in Units IV and VI, which                     expected to be small.
                                                      analysis of exposure scenarios, EPA                     discuss the TCE risk assessment and                       The benefits of TCE in vapor
                                                      then considered how reliably the                        EPA’s regulatory assessment of the use                 degreasing are discussed in Unit VI.D.,
                                                      regulatory options would actually reach                 of TCE in vapor degreasing. A                          along with the availability of
                                                      these benchmarks. For the purposes of                   discussion of the environmental effects                alternatives. The dates that the proposed
                                                      this proposal, EPA found that an option                 of TCE can be found in Unit II.D.                      restrictions would take effect are
                                                      addressed the risk so that it was no                       With respect to the costs and benefits              discussed in Unit X.D., as is the
                                                      longer unreasonable if the option could                 of this proposal and the alternatives                  availability of alternatives to TCE vapor
                                                      achieve the benchmark MOE or cancer                     EPA considered, as well as the impacts                 degreasing on those dates.
                                                      benchmark for the most sensitive                        on small businesses, the full analysis is                 Finally, with respect to this proposal’s
                                                      endpoint. In evaluating whether a                       presented in the economic analysis                     effect on technological innovation, EPA
                                                      regulatory option would ensure that the                 document (Ref. 3) To the extent                        expects this action to spur innovation,
                                                      chemical substance no longer presents                   information was available, EPA                         not hinder it. (Ref. 3) An impending ban
                                                      the identified unreasonable risks, the                  considered the benefits realized from                  on the use of TCE in vapor degreasing
                                                      Agency considered whether the option                    risk reductions (including monetized                   is likely to increase demand for
                                                      could be realistically implemented or                   benefits, non-monetized quantified                     alternatives, which would be expected
                                                      whether there were practical limitations                benefits, and qualitative benefits),                   to result in the development of new
                                                      on how well the option would mitigate                   offsets to benefits from countervailing                alternatives.
                                                      the risks in relation to the benchmarks,                risks (e.g., risks from chemical
                                                      as well as whether the option’s                         substitutions and alternative practices),              C. Regulatory Options Receiving Limited
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                                                      protectiveness was impacted by                          the relative risk for environmental                    Evaluation
                                                      environmental justice or children’s                     justice populations and children and                     As discussed previously, EPA
                                                      health concerns.                                        other potentially exposed or susceptible               analyzed a wide range of regulatory
                                                                                                              subpopulations (as compared to the                     options under TSCA section 6(a). One of
                                                      B. TSCA Section 6(c)(2) Considerations                  general population), and the cost of                   the options EPA evaluated involved a
                                                        TSCA section 6(c)(2) requires EPA to                  regulatory requirements for the various                TSCA section 6(a)(3) requirement for
                                                      consider and publish a statement based                  options. A discussion of the benefits                  warning labels or instructions on
                                                      on reasonably available information                     EPA considered can be found in Units                   containers of TCE or on vapor
                                                      with respect to the:                                    VI.C. and VII.                                         degreasing equipment. However, EPA


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                           7441

                                                      reasoned that warning labels and                        TSCA section 6(a) that do not pertain to                  The five basic types of batch vapor
                                                      instructions alone could not mitigate the               this action and were therefore not                     degreasers are described in the
                                                      identified unreasonable risks presented                 evaluated for this proposed rulemaking.                following paragraphs (Ref. 30):
                                                      by TCE to workers operating vapor                       First, EPA reasoned that the TSCA                         As the name suggests, open-top vapor
                                                      degreasing equipment. In making this                    section 6(a)(1) regulatory option to                   degreasers are open at the top to allow
                                                      finding, EPA considered several factors                 prohibit the manufacture (including                    introduction of the parts to be cleaned.
                                                      including the fact that, in many cases,                 import), processing or distribution in                 Heating elements at the bottom of the
                                                      the workers being exposed are not in a                  commerce of TCE or limit the amount of                 cleaner heat the liquid solvent to above
                                                      position to influence their employer’s                  TCE which may be manufactured                          its boiling point. Solvent vapor rises in
                                                      decisions about the type of solvent or                  (including imports), processed or                      the machine to the height of chilled
                                                      the type of degreasing equipment that                   distributed in commerce is not germane                 condensing coils on the inside walls of
                                                      will be used, or ensure that their                      because the Agency is not proposing to                 the cleaner. The condensing coils cool
                                                      employer provides appropriate PPE and                   ban or limit the manufacture (including                the vapor, causing it to condense and
                                                      an adequate respiratory protection                      import), processing or distribution in                 return to the bottom of the cleaner.
                                                      program. EPA also considered the                        commerce of TCE for uses other than in                 Cleaning occurs in the vapor zone above
                                                      analysis of relevant studies that was                   vapor degreasing, aerosol degreasing or                the liquid solvent and below the
                                                      discussed in the prior proposal on TCE                  for spot cleaning in dry cleaning                      condensing coils, as the hot vapor
                                                      (Ref. 33). This analysis found that even                facilities at this time. In addition, EPA              solvent condenses on the cooler work
                                                      professional users do not consistently                  reasoned that the TSCA section 6(a)(6)                 surface. The workload or a parts basket
                                                      pay attention to labels; they often do not              regulatory option to prohibit or                       is lowered into the heated vapor zone
                                                      understand label information; and they                  otherwise regulate any manner or                       with a mechanical hoist. While the
                                                      often base a decision to follow label                   method of disposal of the chemical is                  condensing coils reduce the amount of
                                                      information on previous experience and                  not applicable since EPA did not                       solvent that escapes the vapor zone,
                                                      perceptions of risk (Ref. 33).                          evaluate the risks associated with                     they do not eliminate emissions, and
                                                         EPA found that presenting                            ongoing TCE disposal.                                  throughout the degreasing process,
                                                      information about TCE on a label would                                                                         significant vapor emissions of the
                                                      not adequately address the identified                   VI. Regulatory Assessment of TCE Use                   solvent can occur. These vapor
                                                      unreasonable risks because the nature of                in Vapor Degreasing                                    emissions are hazardous to workers
                                                      the information the user or owner                         This Unit describes the current use of               operating the machine, as well as nearby
                                                      would need to read, understand, act                     TCE in vapor degreasing, the                           workers. In addition, replacing solvent
                                                      upon, convey, and ensure adherence to                   unreasonable risks presented by this                   lost to emissions can be costly. In
                                                      is extremely complex. It would be                       use, and how EPA identified which                      assessing the use of TCE in vapor
                                                      challenging to most users or owners to                  regulatory options address those                       degreasers, the TCE risk assessment
                                                      follow or convey the complex product                    unreasonable risks so that TCE in vapor                focused on the use of open top vapor
                                                      label instructions required to explain                                                                         degreasing systems.
                                                                                                              degreasing no longer presents such
                                                      how to reduce exposures to the                                                                                    Vapor emissions of solvent can be
                                                                                                              unreasonable risks.
                                                      extremely low levels needed to                                                                                 reduced by enclosing the vapor
                                                      minimize the risk from TCE. Rather than                 A. Description of the Current Use                      degreasing machine. Open top vapor
                                                      a simple message, the label would need                                                                         degreasing systems with enclosures
                                                                                                                 Vapor degreasing is a cleaning process              operate in the same manner as standard
                                                      to explain a variety of inter-related
                                                                                                              that uses a solvent vapor to remove                    open top vapor degreasing systems,
                                                      factors, including but not limited to the
                                                                                                              contaminants such as grease, oils, dust,               except that the machine is enclosed on
                                                      use of local exhaust ventilation,
                                                      respirators and assigned protection                     and dirt from fabricated parts. Solvents               all sides during degreasing. The
                                                      factor for the user and bystanders, and                 such as TCE are boiled in a degreasing                 enclosure is opened and closed when
                                                      time periods during pregnancy with                      unit to produce a hot vapor. When parts                adding or removing parts, and solvent is
                                                      susceptibility of the developing fetus to               are placed into the degreaser, the hot                 exposed to the air when the cover is
                                                      acute developmental effects, as well as                 vapor within the unit condenses onto                   open. Nearly all open top vapor
                                                      effects to bystanders. It is unlikely that              the parts, causing beading and dripping.               degreasing systems regulated by the
                                                      label language changes for this use will                The dripping action carries the                        NESHAP have a cover because that is a
                                                      result in widespread, consistent, and                   contaminants away from the fabricated                  more common compliance strategy than
                                                      successful adoption of risk reduction                   part, leaving behind a clean surface.                  complying with the overall emission
                                                      measures by users and owners.                           After vapor degreasing, the parts are                  limit. A variety of additional controls
                                                         While labeling alone would not                       suspended on a rack in order to drain                  may be needed to comply with the
                                                      address the identified unreasonable                     the solvent (Ref. 30). Vapor degreasing                NESHAP, including two-part covers,
                                                      risks so that TCE used in vapor                         is used in a variety of occupational                   extended freeboard (the area above the
                                                      degreasing no longer presents such                      settings such as metal plating,                        vapor zone), freeboard refrigeration
                                                      risks, EPA recognizes that the TSCA                     electronics assembly, metal or                         devices, and holding cleaned parts in
                                                      section 6(a)(3) warnings and instruction                composite part fabrication, and repair                 the freeboard to allow draining.
                                                      requirement can be an important                         shops.                                                 Enclosed vapor degreasing systems may
                                                      component of an approach that                              Vapor degreasing may take place in                  be vented directly to the atmosphere or
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                                                      addresses identified unreasonable risks                 batches or as part of an in-line (i.e.,                first vented to an external carbon filter
                                                      with a specific use prohibition. EPA has                continuous) system. In batch machines,                 and then to the atmosphere.
                                                      included a simple downstream                            each load (parts or baskets of parts) is                  Solvent emissions can be further
                                                      notification requirement as part of this                loaded into the machine after the                      reduced by using a sealed, closed-loop
                                                      proposed rule to ensure that users                      previous load is completed. With in-line               degreasing system. In airtight closed-
                                                      would be made aware of the ban on the                   systems, parts are continuously loaded                 loop systems, parts are placed into a
                                                      use of TCE in vapor degreasing.                         into and through the vapor degreasing                  basket, which is then placed into an
                                                         In addition, early in the process, EPA               equipment as well as the subsequent                    airtight work chamber. The door is
                                                      identified two regulatory options under                 drying steps.                                          closed and solvent vapors are sprayed


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                                                      7442                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      onto the parts. When cleaning is                        of the cleaning zone; these systems are                consistent with the methodology used
                                                      complete, vapors are exhausted from the                 typically used when parts are already                  in the risk assessment for closed-loop,
                                                      work chamber and circulated over a                      being transported through                              conveyorized, and continuous web
                                                      cooling coil to condense and recover the                manufacturing areas by a conveyor.                     degreasers and identified cancer and
                                                      solvent. The parts are dried by forced                  Cross-rod degreasers use two parallel                  non-cancer risks from acute and chronic
                                                      hot air. Air is circulated through the                  chains connected by a rod to support                   exposure for each of the scenarios (Ref.
                                                      chamber and residual solvent vapors are                 the parts, which are typically loaded                  30). EPA estimates that there are
                                                      captured by carbon adsorption. The                      manually into perforated baskets or                    approximately 2,600 to 6,000 open top
                                                      door is opened when the residual                        cylinders. Ferris wheel degreasing                     vapor degreasing systems currently
                                                      solvent vapor concentration has reached                 systems, generally the smallest of the                 using TCE, 120 closed-loop systems
                                                      a specified level.                                      conveyorized degreasers, rotate                        currently using TCE, and 150 in-line
                                                         A refinement of the airtight closed-                 manually-loaded baskets or cylinders of                (either conveyorized or continuous web)
                                                      loop degreasing system is the airless                   parts vertically through the cleaning                  systems currently using TCE, with an
                                                      degreasing system. An airless system                    zone and back out. Belt degreasers are                 estimated 17 workers and occupational
                                                      removes air at some point during the                    used for simple and rapid loading and                  bystanders per machine (Ref. 3). This
                                                      degreasing process. Typically, this takes               unloading of parts; the parts are loaded               means that there are an estimated
                                                      the form of drawing vacuum, but some                    onto a mesh conveyor belt that                         40,800 to 102,000 persons exposed to
                                                      machines purge the air with nitrogen. In                transports them through the cleaning                   TCE from open top vapor degreasing
                                                      airless degreasing systems with vacuum                  zone and out the other side.                           systems, 2,040 persons exposed to TCE
                                                      drying, a vacuum is generated, typically                   There are also continuous web                       from closed-loop systems, and 2,550
                                                      below 5 torr, which dries the parts. A                  cleaning machines (Ref. 30). These in-                 persons exposed to TCE from in-line
                                                      vapor recovery system recovers the                      line degreasers differ from typical                    systems.
                                                      solvent.                                                conveyorized degreasers in that they are                  b. Impacts on minority and low
                                                         The greatest solvent emission                        specifically designed for cleaning parts               income populations. There is no known
                                                      reductions are achieved with the airless                that are coiled or on spools such as                   disproportionate representation of
                                                      vacuum-to-vacuum degreasing system.                     films, wires, metal strips, and metal                  minority or low income populations in
                                                      These systems are referred to as airless                sheets. In continuous web degreasers,                  these occupations.
                                                      because the entire cycle is operated                    parts are uncoiled and loaded onto                        c. Impacts on children. EPA has
                                                      under vacuum. Typically, parts are                      rollers that transport the parts through               concerns for effects on the developing
                                                      placed into the chamber, the chamber                    the cleaning and drying zones at speeds                fetus from acute and chronic worker and
                                                      sealed, and then vacuum drawn within                    typically greater than 11 feet per                     occupational bystander exposures to
                                                      the chamber. The parts are then sprayed                 minute. The parts are then recoiled or                 TCE used in vapor degreasers. The risk
                                                      with hot solvent vapor, which raises the                cut after exiting the machine.                         estimates are focused on pregnant
                                                      pressure in the chamber. The parts are                                                                         women because one of the most
                                                      dried by again drawing vacuum in the                    B. Analysis of Regulatory Options                      sensitive health effects associated with
                                                      chamber. Solvent vapors are recovered                     In this unit, EPA explains how it                    TCE exposure from vapor degreasing is
                                                      through compression and cooling. An                     evaluated whether the regulatory                       adverse effects on the developing fetus.
                                                      air purge then removes residual vapors                  options considered would address the                   The potential risk due to exposure
                                                      which can be routed to an optional                      unreasonable risks presented by the                    during pregnancy is significant.
                                                      carbon adsorber and then out a vent.                    current use so that TCE in vapor                       Approximately half of all pregnancies
                                                      Finally, air is introduced to return the                degreasing no longer presents such                     are unintended. If a pregnancy is not
                                                      chamber to atmospheric pressure so that                 unreasonable risks. First, EPA                         planned before conception, a woman
                                                      the chamber can be opened. These                        characterizes the unreasonable risks                   may not be in optimal health for
                                                      systems have the added benefit of                       associated with the current use of TCE                 childbearing (Ref. 34). More specifically,
                                                      generating vapor at a much lower                        in vapor degreasers. Then, the Agency                  in this case, a woman who is not
                                                      temperature than open-top degreasing                    describes its initial analysis of which                planning a pregnancy may not take
                                                      systems because the boiling point of                    regulatory options have the potential to               steps to avoid exposure to TCE in vapor
                                                      TCE is lower at the lower pressure of                   reach the protective non-cancer and                    degreasing. EPA estimates that there are
                                                      these systems.                                          cancer benchmarks. The levels of acute                 over 1,000 pregnant women exposed to
                                                         In contrast to batch degreasers, in-line             and chronic exposures estimated to                     TCE as a result of vapor degreasers.
                                                      vapor degreasing systems use an                         present low risk for non-cancer effects                   d. Specific vapor degreaser exposure
                                                      automated parts handling system, often                  also result in low risk for cancer. Lastly,            information. In the supplemental
                                                      a conveyor, to automatically provide a                  this unit evaluates how well those                     analysis (Ref. 30), EPA estimated
                                                      continuous supply of parts to be cleaned                regulatory options would address the                   baseline exposures for all batch vapor
                                                      (Ref. 30). Conveyorized vapor                           identified unreasonable risks in                       degreasing machines, regardless of
                                                      degreasing systems are usually fully                    practice.                                              facility size, and for in-line vapor
                                                      enclosed except for the conveyor inlet                    1. Risks associated with the current                 degreasing machines (both conveyorized
                                                      and outlet portals. Conveyorized                        use. a. General impacts. The TCE risk                  and continuous web). Baseline
                                                      degreasers are likely used in the same                  assessment identified cancer and                       exposures for in-line machines were not
                                                      applications as batch vapor degreasers,                 non-cancer risks from acute and chronic                specifically calculated in the TCE risk
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      except that they would be used in larger                exposure for workers operating vapor                   assessment. For the supplemental
                                                      operations, where the number of parts                   degreasers and for occupational                        analysis, estimating the baseline
                                                      being cleaned is large enough to warrant                bystanders, nearby workers who have                    exposures involved using a near-field/
                                                      the use of a conveyorized system.                       the potential to be exposed to TCE but                 far-field modeling approach to estimate
                                                      Conveyorized degreasers use different                   are not directly involved with                         airborne concentrations of TCE and
                                                      methods for transporting the parts                      degreasing operations (Ref. 2). Because                Monte Carlo simulation to establish the
                                                      through the cleaning zone. For example,                 the TCE risk assessment focused on                     range and likelihood of exposures. The
                                                      monorail degreasers use a straight-line                 open top vapor degreasing systems, EPA                 near-field/far-field model estimates
                                                      conveyor to transport parts into and out                performed supplemental analysis                        airborne concentrations in a near field (a


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                           7443

                                                      zone close to the source of exposure)                   three types of closed-loop systems                     for fetal heart malformations is 0.003.
                                                      and a far field (a zone farther from the                (airtight, airless, and airless vacuum-to-             The MOEs for every vapor degreasing
                                                      source of exposure but within the                       vacuum) with respect to employee                       scenario are below the benchmark MOE.
                                                      occupational building). Controls                        exposures. As a result, for the purpose                Based on this assessment, EPA’s
                                                      required by the 2007 NESHAP were                        of assessing exposure, EPA assumed                     proposed determination is that acute
                                                      accounted for in the estimations. (Ref.                 that all of the closed-loop systems                    TCE exposures from vapor degreasing
                                                      30) EPA used these estimated airborne                   achieve a 98% reduction in exposure                    present unreasonable risks.
                                                      concentrations to estimate 8-hour time                  compared to open top vapor degreasing                     Chronic exposures from TCE use in
                                                      weighted average (TWA) exposures for                    systems (Ref. 30). This assumption leads               vapor degreasing also present risks. For
                                                      workers (i.e., in the near field) and                   to exposure estimates of 0.05 ppm to 9.8               non-cancer effects, the most sensitive of
                                                      occupational bystanders (i.e., in the far               ppm for workers.                                       which are developmental, the
                                                      field). Details of the modeling and                        However, the assumption of a 98%                    benchmark MOE is also 10. For chronic
                                                      estimation method for calculating                       reduction in exposures compared to                     exposures associated with open top
                                                      exposure levels during vapor degreasing                 open top vapor degreasing systems may                  vapor degreasing systems, conveyorized
                                                      are available in the supplemental                       be an overestimate for airtight systems,               systems, continuous web systems, and
                                                      analysis document (Ref. 30). This                       and an underestimate for airless                       closed-loop systems, the MOEs are
                                                      analysis is based on the methodology                    vacuum-to-vacuum systems. EPA                          0.00008, 0.00001, 0.00007, and 0.004,
                                                      used in the peer reviewed TCE risk                      requests information and data on TCE                   respectively. With respect to cancer, the
                                                      assessment (Ref. 2). Prior to                           emissions from all vapor degreasing                    risk posed to workers ranges from 5.16
                                                      promulgation of the final rule, EPA will                systems, particularly information and                  × 10¥1 for open top vapor degreasing
                                                      peer review the ‘‘supplemental                          data that would enable EPA to better                   systems to 1 × 10¥2 for closed-loop
                                                      Occupational Exposure and Risk                          distinguish between the different types                systems, exceeding common cancer
                                                      Reduction Technical Report in Support                   of closed-loop systems.                                benchmarks of 10¥6 to 10¥4 (Refs. 2,
                                                      of Risk Management Options for                             The SBAR Panel convened in support                  30). Therefore, EPA’s proposed
                                                      Trichloroethylene (TCE) Use in Vapor                    of this action heard from several SERs                 determination is that chronic TCE
                                                      Degreasing’’ (Ref. 30).                                 who disagreed with EPA’s exposure                      exposures due to vapor degreasing also
                                                         The estimated 8-hour TWA exposure                    estimates. These SERs indicated that                   present unreasonable risks.
                                                      levels for open top vapor degreasing                    fewer employees were involved in the                      The SBAR Panel convened in support
                                                      systems ranged from 2.74 ppm to 491.36                  degreasing operation, or that the                      of this action heard from several SERs
                                                      ppm for workers, with the 50th                          machines were operated for fewer hours                 who expressed concerns about the
                                                      percentile at 55.16 ppm and the 99th                    per day than EPA estimated. However,                   underlying TCE risk assessment. Many
                                                      percentile at 190.17 ppm. For                           another SER stated that his degreasing                 of the concerns expressed by these SERs
                                                      occupational bystanders, the exposure                   machines run ten hours a day during the                were already expressed in the public
                                                      levels ranged from 0.33 ppm to 440.61                   week and six hours on Saturdays, which                 comments and the peer review
                                                      ppm, with the 50th percentile at 20.45                  exceeds EPA’s estimate. In addition,                   comments on the risk assessment. The
                                                      ppm and the 99th percentile at 144.93                   most SERs thought that EPA’s estimated                 Summary of External Peer Review and
                                                      ppm. The estimated 8-hour TWA                           TWAs were too high, and EPA received                   Public Comments and Disposition
                                                      exposure levels for conveyorized                        some monitoring data indicating lower                  document explains how EPA responded
                                                      degreasers were even higher, ranging                    exposures, but several SERs stated that                to the comments received (Ref. 35).
                                                      from 5.14 ppm to 32,722 ppm for                         they complied with the recommended                        2. Initial analysis of potential
                                                      workers, with the 50th percentile and                   exposure limit of the American                         regulatory options. Having identified
                                                      99th percentile being 180.74 ppm and                    Conference of Governmental Industrial                  unreasonable risks from the use of TCE
                                                      1162.6 ppm, respectively. For                           Hygienists (ACGIH) of 10 ppm, which is                 in vapor degreasing, EPA evaluated
                                                      bystanders, the levels ranged from 0.63                 within the exposure ranges estimated by                whether regulatory options under TSCA
                                                      ppm to 29,410 ppm, with the 50th                        EPA. However, EPA specifically                         section 6(a) could reach the risk (non-
                                                      percentile and 99th percentile being                    requests exposure data, especially data                cancer and cancer) benchmarks.
                                                      80.93 ppm and 745.11 ppm,                               involving employee exposure                               EPA assessed a number of exposure
                                                      respectively. The estimated 8-hour TWA                  monitoring.                                            scenarios associated with risk reduction
                                                      exposure levels for continuous web                         e. Specific risks for TCE use in vapor              options in order to find variations in
                                                      degreasers were lower overall than for                  degreasers. Inhalation risks were                      TCE exposure from vapor degreasing,
                                                      open top vapor degreasing systems or                    estimated for all acute exposure                       including: Reducing the amount of TCE
                                                      conveyorized degreasers. These                          scenarios and risks were identified for                in the degreasing formulation, with
                                                      estimates ranged from 4.18 ppm to 50.61                 all types of machines, regardless of the               concentrations varying from 5% to 95%
                                                      ppm for workers, with the 50th                          type of exposure (typical vs. reasonable               by weight in the product, engineering
                                                      percentile and 99th percentile being                    worst case scenario). For acute                        controls, equipment substitution, and
                                                      8.18 ppm and 22.42 ppm, respectively.                   exposures associated with open top                     use of PPE. EPA also assessed
                                                      For bystanders, the levels ranged from                  vapor degreasing systems, the MOE is                   combinations of these options.
                                                      0.52 ppm to 45.49 ppm, with the 50th                    0.00006 for fetal heart malformations.                    For the engineering controls risk
                                                      percentile and 99th percentile being                    This equates to exposures that are many                reduction option exposure scenarios,
                                                      3.70 ppm and 17.49 ppm, respectively.                   times greater than the benchmark MOE                   EPA evaluated using local exhaust
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                                                         As part of this supplemental analysis,               of 10. The MOE for fetal heart                         ventilation to improve ventilation near
                                                      EPA also evaluated the exposure                         malformations from acute exposures                     the vapor degreaser, with an assumed
                                                      reductions that would result from                       associated with conveyorized systems is                90% reduction in exposure over
                                                      switching from an open top vapor                        0.00001, while for continuous web                      baseline levels. The equipment
                                                      degreasing system to a closed-loop                      systems, the MOE is 0.0005. Even for                   substitution risk reduction option was
                                                      vapor degreasing system. The data                       acute exposures with closed-loop                       only evaluated with respect to open top
                                                      available on TCE emissions from closed-                 systems, which we assume reduce TCE                    vapor degreasing systems, the
                                                      loop systems was not sufficient to                      emissions as much as 98% from open                     evaluation assumed substitution of a
                                                      enable EPA to distinguish between the                   top vapor degreasing systems, the MOE                  closed-loop system for the open top


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                                                      7444                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      vapor degreasing system. EPA did not                    reductions needed would only be                           As discussed in Unit IV, the baseline
                                                      identify any equipment substitution                     achieved by a reduction in the                         risk for exposure to workers and
                                                      options for either conveyorized or                      concentration of TCE in the degreasing                 occupational bystanders for vapor
                                                      continuous web systems; it is likely that               solution to 5%. At 5% TCE, the                         degreasing does not achieve the non-
                                                      a closed-loop system, being a batch-                    effectiveness of the solution would be                 cancer MOE benchmarks for all non-
                                                      process system, would not meet the                      greatly reduced. Additional exposure                   cancer effects (e.g., developmental
                                                      specialized production requirements of                  level estimates for various scenarios are              effects, kidney toxicity, and
                                                      facilities currently using conveyorized                 available in the supplemental analysis                 immunotoxicity) or the common cancer
                                                      or continuous web systems. EPA                          document, which also documents                         benchmarks. Under this proposed
                                                      requests comment, information, and                      options that did not meet the risk                     approach, exposures to TCE from use in
                                                      data on potential equipment                             benchmarks and which do not, for                       vapor degreasing would be completely
                                                      substitution options for these systems,                 purposes of this proposal, address the                 eliminated. As a result, both non-cancer
                                                      including both emissions and cost                       identified unreasonable risks (Ref. 30).               and cancer risks from this use of TCE
                                                      information. The PPE risk reduction                        3. Assessment of whether regulatory                 would be eliminated.
                                                      option exposure scenarios evaluated                     options address the identified                            The proposed approach would ensure
                                                      workers and occupational bystanders                     unreasonable risks to the extent                       that employees are no longer at risk
                                                      wearing respirators with an assigned                    necessary so that TCE no longer                        from TCE exposure associated with
                                                      protection factor (APF) varying from 10                 presents such unreasonable risks. After                vapor degreasing. Prohibiting the
                                                      to 10,000. Additionally, EPA evaluated                  excluding the unrealistic options                      manufacturing (including import),
                                                      various combinations of these options,                  involving reductions in the amount of                  processing and distribution in
                                                      including PPE with each of the other                    TCE in the solvent solution, only two                  commerce of TCE for use in vapor
                                                      three options and reducing the amount                   options were left that had the potential               degreasing would minimize the
                                                      of TCE in the solvent solution with each                to address the identified unreasonable                 availability of TCE for vapor degreasing.
                                                      of the other three options. The way that                risks. These options were: (a)                         The downstream notification of these
                                                      closed-loop systems operate may render                  Prohibiting under TSCA section 6(a)(2)                 restrictions ensures that processors,
                                                      local exhaust ventilation redundant,                    the manufacturing (including import),                  distributors, and other purchasers are
                                                      because ventilation is being done as part               processing, and distribution in                        aware of the manufacturing (including
                                                      of the closed system, so EPA did not                    commerce of TCE for use in vapor                       import), processing, distribution in
                                                      evaluate local exhaust ventilation and                                                                         commerce and use restrictions for TCE
                                                                                                              degreasing, prohibiting the commercial
                                                      equipment substitution together. EPA                                                                           in vapor degreasing, and helps to ensure
                                                                                                              use of TCE in vapor degreasing under
                                                      requests comment on the accuracy of                                                                            that the rule is effectively implemented
                                                                                                              TSCA section 6(a)(5), and requiring
                                                      EPA’s assumption that these control                                                                            by discouraging off-label use of TCE
                                                                                                              downstream notification under TSCA
                                                      options are mutually exclusive.                                                                                manufactured for other uses.
                                                                                                              section 6(a)(3) when distributing TCE;
                                                         EPA has estimated that, in order to                                                                         Downstream notification is important
                                                                                                              and (b) prohibiting under TSCA section
                                                      avoid cancer and non-cancer                                                                                    because EPA is not proposing to
                                                                                                              6(a)(2) the manufacturing (including
                                                      unreasonable risks, the 8-hour TWA                                                                             prohibit manufacturing, processing and
                                                                                                              import), processing, and distribution in
                                                      exposure should be approximately 1                                                                             all uses of TCE, just those activities
                                                                                                              commerce of TCE for use in vapor
                                                      ppb (Ref. 36). However, EPA’s                                                                                  associated with vapor degreasing. This
                                                                                                              degreasing except in closed-loop vapor                 integrated supply chain approach is
                                                      inhalation exposure level estimates for
                                                      all types of vapor degreasing machines                  degreasing machines, prohibiting under                 necessary to address the identified
                                                      exceed that figure by several orders of                 TSCA section 6(a)(5) the commercial                    unreasonable risks presented by the use
                                                      magnitude.                                              use of TCE in vapor degreasing except                  of TCE in vapor degreasing. In addition,
                                                         Of the control options evaluated by                  in closed-loop vapor degreasing                        the proposed approach would provide
                                                      EPA in its supplemental analysis (Ref.                  machines, requiring downstream                         staggered compliance dates for
                                                      30), which did not include a ban on the                 notification under TSCA section 6(a)(3)                implementing the prohibition on
                                                      use of TCE in vapor degreasing, the only                when distributing TCE, and requiring,                  manufacturing (including import),
                                                      control options that achieved the                       under TSCA section 6(a)(5), appropriate                processing, distribution in commerce,
                                                      necessary exposure reductions for                       PPE (or an exposure limit alternative)                 and commercial use in order to avoid
                                                      workers operating the degreaser                         for both workers operating closed-loop                 undue impacts on the businesses
                                                      involved PPE in addition to other                       vapor degreasing machines containing                   involved.
                                                      measures. Even switching from an open                   TCE and for occupational bystanders.                      b. Variation of the proposed approach
                                                      top vapor degreasing system to a closed-                   a. Proposed approach to prohibit                    that would allow the use of TCE in
                                                      loop system did not achieve the                         manufacturing (including import),                      closed-loop vapor degreasing systems
                                                      necessary reductions without the                        processing, distribution in commerce,                  and require under TSCA section 6(a)(5)
                                                      addition of PPE with an APF of 10,000.                  and use of TCE for vapor degreasing                    the use of personal protective
                                                      For that control option, equipment                      and require downstream notification. As                equipment in vapor degreasing
                                                      substitution plus PPE, EPA estimated                    noted previously, the proposed                         operations in which TCE is used.
                                                      that worker exposure levels would be                    regulatory approach is to prohibit the                 Another regulatory option that EPA
                                                      0.4 ppb. Other combinations of control                  manufacturing (including import),                      considered was to allow the use of TCE
                                                      options, such as reducing the amount of                 processing, and distribution in                        in closed-loop vapor degreasing systems
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                                                      TCE in the solvent solution and PPE                     commerce of TCE for vapor degreasing                   and require respiratory protection
                                                      with an APF of 10,000, or reducing the                  under TSCA section 6(a)(2), prohibit the               equipment for workers operating the
                                                      amount of TCE in the solvent solution                   commercial use of TCE in vapor                         equipment in the form of a full face
                                                      and engineering controls and PPE,                       degreasing under TSCA section 6(a)(5),                 piece self-contained breathing apparatus
                                                      achieved exposure reductions of                         and require manufacturers, processors,                 (SCBA) in pressure demand mode or
                                                      approximately the same magnitude.                       and distributors, except for retailers, to             other positive pressure mode with an
                                                      However, EPA found that these                           provide downstream notification, e.g.,                 APF of 10,000 with an alternative to the
                                                      combinations are unlikely to be                         via a Safety Data Sheet (SDS), of the                  specified APF respirator of an air
                                                      practical for users because the exposure                prohibition under TSCA section 6(a)(3).                exposure limit. EPA’s analysis found


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                           7445

                                                      that use of a SCBA with an APF of                       business settings where they are not                   implementation of a respiratory
                                                      10,000 for workers operating closed-                    already using respirators.                             protection program is likely to be
                                                      loop vapor degreasing systems that                        In addition, OSHA adopted a                          difficult for many vapor degreasing
                                                      contain TCE could control TCE air                       hierarchy of controls established by the               facilities. In addition, EPA’s economic
                                                      concentration to levels that ensure that                industrial hygiene community used to                   analysis indicates that this option is
                                                      TCE no longer presents the identified                   protect employees from hazardous                       more expensive than switching to a
                                                      unreasonable risks. Depending on air                    airborne contaminants, such as TCE                     different solvent or cleaning system.
                                                      concentrations and proximity to the                     (see, e.g., 29 CFR 1910.134(a)(1), 29 CFR              However, EPA requests comment,
                                                      vapor degreasing equipment, other                       1910.1000(e), and OSHA’s substance                     information, and data on the utility and
                                                      employees in the area would also need                   specific standards in 29 CFR 1910                      feasibility of this option and whether, if
                                                      to wear respiratory protection                          subpart Z). According to the hierarchy,                it were adopted, it should be
                                                      equipment.                                              substitution of less toxic substances,                 implemented by specifying the vapor
                                                         Although respirators could reduce                    engineering controls, administrative                   degreasing technology and either
                                                      exposures to levels that are protective of              controls, and work practice controls are               requiring specific PPE or compliance
                                                      non-cancer and cancer risks, there are                  the preferred method of compliance for                 with an air exposure limit. If EPA were
                                                      many documented limitations to                          protecting employees from airborne                     to specify both the vapor degreasing
                                                      successful implementation of respirators                contaminants and are to be                             technology and the required PPE with
                                                      with an APF of 10,000. Not all workers                  implemented first, before respiratory                  the alternative air exposure limit in the
                                                                                                              protection is used. OSHA permits                       final rule, EPA would require the vapor
                                                      can wear respirators. Individuals with
                                                                                                              respirators to be used where engineering               degreasing system to be an airless
                                                      impaired lung function, due to asthma,
                                                                                                              controls are not feasible or during an                 vacuum-to-vacuum closed-loop system
                                                      emphysema, or chronic obstructive
                                                                                                              interim period while such controls are                 and the PPE to have an APF of 10,000
                                                      pulmonary disease, for example, may be
                                                                                                              being implemented.                                     or otherwise meet the air exposure limit
                                                      physically unable to wear a respirator.                   Under this approach, a company
                                                      Determination of adequate fit and                                                                              of 1 ppb as an 8-hour TWA. As
                                                                                                              could choose to use a closed-loop                      previously discussed, EPA’s assessment
                                                      annual fit testing is required for a tight              system coupled with an air exposure                    of worker exposure from closed-loop
                                                      fitting full-facepiece respirator to                    limit. In order to reach the health                    systems relies on an assumption that
                                                      provide the required protection. Also,                  benchmarks, the air exposure limit                     emissions from each closed-loop system
                                                      difficulties associated with selection, fit,            would have to be 1 ppb as an 8-hour                    are 98% less than the emissions from an
                                                      and use often render them ineffective in                TWA. Based on EPA’s analysis, the only                 open top vapor degreasing system. EPA
                                                      actual application, preventing the                      way to achieve an air exposure limit of                is requesting information on whether
                                                      assurance of consistent and reliable                    1 ppb is with a combination of a closed-               releases from the use of TCE in an
                                                      protection, regardless of the assigned                  loop vapor degreaser and a respirator                  airless vacuum-to-vacuum closed-loop
                                                      capabilities of the respirator.                         with an APF of 10,000. However, as                     system would result in air levels that are
                                                      Individuals who cannot get a good                       previously discussed, EPA                              at or below the air exposure limit of 1
                                                      facepiece fit, including those                          acknowledges that available data is                    ppb. To the extent that EPA receives
                                                      individuals whose beards or sideburns                   limited, particularly with respect to the              information that indicates that this is
                                                      interfere with the facepiece seal, would                different types of closed-loop vapor                   the case, EPA would consider finalizing
                                                      be unable to wear tight fitting                         degreasers. It is possible that the more               this rule to exclude airless vacuum-to-
                                                      respirators. In addition, respirators may               sophisticated airless vacuum-to-vacuum                 vacuum closed-loop systems. In
                                                      also present communication problems                     closed-loop systems have lower                         contrast, this assumption of a 98%
                                                      and vision problems, increase worker                    emissions than EPA estimated, and,                     reduction may be overly generous for
                                                      fatigue, and reduce work efficiency (Ref.               therefore, respiratory protection with an              the most basic of the closed-loop
                                                      37). According to OSHA, ‘‘improperly                    APF of 10,000 may not be necessary for                 systems, and operators of such systems,
                                                      selected respirators may afford no                      operators. As part of this approach, EPA               even when wearing PPE with an APF of
                                                      protection at all (for example, use of a                believes it would be necessary to                      10,000, would continue to be exposed to
                                                      dust mask against airborne vapors), may                 establish employee exposure monitoring                 the identified unreasonable risks. Under
                                                      be so uncomfortable as to be intolerable                requirements to ensure that employee                   the optional approach, companies
                                                      to the wearer, or may hinder vision,                    exposures are measured accurately and                  choosing to keep using TCE would have
                                                      communication, hearing, or movement                     that employees are not exposed to the                  to comply with all of OSHA’s
                                                      and thus pose a risk to the wearer’s                    identified unreasonable risks associated               requirements for respiratory protection
                                                      safety or health.’’ (Ref. 37, at 1189–                  with TCE use in vapor degreasing. EPA                  programs, including fit-testing and
                                                      1190). Nonetheless, it is sometimes                     would require upfront monitoring                       medical monitoring.
                                                      necessary to use respiratory protection                 representative of each exposed
                                                      to control exposure. The OSHA                           employee’s exposures and would model                   C. Adverse Health Effects and Related
                                                      respiratory protection standard requires                the requirements on comparable OSHA                    Impacts That Would Be Prevented by
                                                      employers to establish and implement a                  requirements as well as on the New                     the Proposed Option
                                                      respiratory protection program to                       Chemical Exposure Limit (NCEL)                            The proposed option would prevent
                                                      protect their respirator-wearing                        requirements that EPA has long used in                 exposure to TCE from vapor degreasing
                                                      employees (Ref. 38). This OSHA                          addressing employee exposure to                        and thus would prevent the risks of
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                                                      standard contains a number of                           chemicals undergoing review under                      adverse effects and associated impacts.
                                                      implementation requirements, e.g., for                  TSCA section 5 (Refs. 38–39). The                      As discussed in Unit IV., TCE exposure
                                                      program administration; worksite-                       requirements would specify how and                     is associated with a wide array of
                                                      specific procedures; respirator selection;              when sampling must be performed and                    adverse health effects. These health
                                                      employee training; fit testing; medical                 how the samples would have to be                       effects include those resulting from
                                                      evaluation; respirator use; respirator                  analyzed.                                              developmental toxicity (e.g., cardiac
                                                      cleaning, maintenance, and repair; and                    EPA is not proposing this option                     malformations, developmental
                                                      other provisions that would be difficult                because substitutes for TCE are                        immunotoxicity, developmental
                                                      to fully implement in some small                        commercially available and                             neurotoxicity, fetal death), toxicity to


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                                                      7446                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      the kidney (kidney damage and kidney                    poorly formed septal wall and valves of                irregular heart beat (arrhythmias),
                                                      cancer), immunotoxicity (systemic                       the heart). While diagnosis for some                   increased risk of infection in the heart
                                                      autoimmune diseases such as                             cardiac defects can occur during                       muscle (infective endocarditis), or
                                                      scleroderma) and severe                                 pregnancy, for other cardiac defects,                  weakness in the heart (cardiomyopathy).
                                                      hypersensitivity skin disorder, non-                    detection may not occur until after birth              In order to stay healthy, a person needs
                                                      Hodgkin’s lymphoma, endocrine and                       or later in life, during childhood or                  regular checkups with a cardiologist.
                                                      reproductive effects (e.g., decreased                   adulthood. These cardiac defects can be                They also might need further operations
                                                      libido and potency), neurotoxicity (e.g.,               occult or life- threatening with the most              after initial childhood surgeries (Ref.
                                                      trigeminal neuralgia), and toxicity to the              severe cases causing early mortality and               40).
                                                      liver (impaired functioning and liver                   morbidity. While the incidences in the                    Depending upon the severity of the
                                                      cancer) (Ref. 2). These health effects                  following paragraphs reflect adverse                   defect, the costs for surgeries, hospital
                                                      associated with exposure to TCE are                     health outcomes beyond just exposure                   stays, and doctor’s appointments to
                                                      serious and can have impacts                            to TCE, the general population numbers                 address a baby’s cardiac defect can be
                                                      throughout a lifetime. The following is                 provide a context for understanding the                significant. The costs for the defects
                                                      a discussion of the impacts of                          impact of the adverse health effects TCE               may also continue throughout a person’s
                                                      significant acute, chronic non-cancer,                  can cause.                                             lifetime. In 2004, hospital costs in the
                                                      and cancer effects associated with TCE                     Nearly 1% or about 40,000 births per                United States for individuals with a
                                                      exposure during vapor degreasing,                       year in the United States are affected by              cardiac defect were approximately $1.4
                                                      including the severity of the effect, the               cardiac defects (Ref. 40). About 25% of                billion (Ref. 40).
                                                      manifestation of the effect, and how the                those infants with a cardiac defect have                  Beyond the monetary cost, the
                                                      effect impacts a person during their                    a critical defect. Infants with critical               emotional and mental toll on parents
                                                      lifetime.                                               cardiac defects generally need surgery                 who discover that their child has a heart
                                                         1. Developmental effects. The TCE                    or other procedures in their first year of             defect while in utero or after birth will
                                                      risk assessment (and EPA’s 2011 IRIS                    life. Some estimates put the total                     be high (Ref. 41). They may experience
                                                      Assessment) identified developmental                    number of individuals (infants,                        anxiety and worry over whether their
                                                      effects as the critical effect of greatest              children, adolescents, and adults) living              child will have a normal life of playing
                                                      concern for both acute and chronic non-                 with cardiac defects at 2 million (Ref.                with friends and participating in sports
                                                      cancer risks. There are increased health                40). Cardiac defects can be caused by                  and other physical activities, or whether
                                                      risks for developmental effects to the                  genetics, environmental exposure, or an                their child may be more susceptible to
                                                      estimated 454 to 1,066 pregnant women                   unknown cause.                                         illness and be limited in the type of
                                                      exposed to TCE during the use of vapor                     Infant deaths resulting from cardiac                work and experiences they can have. In
                                                      degreasers (Ref. 3). Specifically, these                defects often occur during the neonatal                addition, parents can be expected to
                                                      assessments identified fetal cardiac                    period. One study indicated that cardiac               experience concerns over potential
                                                      malformations in the offspring of                       defects accounted for 4.2% of all                      unknown medical costs that may be
                                                      mothers exposed to TCE during                           neonatal deaths. Of infants born with a                looming in the future, lifestyle changes,
                                                      gestation as the critical effect. Although              non-critical cardiac defect, 97% are                   and being unable to return to work in
                                                      fetal cardiac defects are the effect of                 expected to survive to the age of one,                 order to care for their child.
                                                      greatest concern and are the focus of the               with 95% expected to survive to 18                        The emotional and mental toll on a
                                                      discussion in this Unit, TCE exposures                  years of age. Of infants born with a                   person throughout childhood and into
                                                      can result in other adverse                             critical cardiac defect, 75% are expected              adolescence with a heart defect also
                                                      developmental outcomes, including                       to survive to one year of age, with 69%                should be considered (Ref. 41). Cardiac
                                                      prenatal (e.g., spontaneous abortion and                expected to survive to 18 years of age                 patients who are children may feel
                                                      perinatal death, decreased birth weight,                (Ref. 41). A child with a cardiac defect               excluded from activities and feel limited
                                                      and congenital malformations) and                       is 50% more likely to receive special                  in making friends if they have to miss
                                                      postnatal (e.g., reduced growth,                        education services compared to a child                 school due to additional surgeries, or
                                                      decreased survival, developmental                       without birth defects (Ref. 40).                       may not be able to fully participate in
                                                      neurotoxicity, developmental                               Treatments for cardiac defects vary.                sports or other physical exercise.
                                                      immunotoxicity, and childhood                           Some affected infants and children                     Children may feel self-conscious of the
                                                      cancers) effects. TCE exposure during                   might need one or more surgeries to                    scars left by multiple surgeries. This, in
                                                      development results in qualitatively                    repair the heart or blood vessels. In                  turn, adds emotional and mental stress
                                                      different immunotoxic effects than                      other instances, a heart defect cannot be              to the parents as they observe their
                                                      when exposure occurs during                             fully repaired, although treatments have               child’s struggles.
                                                      adulthood. TCE exposure during                          advanced such that infants are living                     As a person with a heart defect enters
                                                      development can influence the                           longer and healthier lives. Many                       adulthood, the emotional or mental toll
                                                      development of the immune system and                    children are living into adulthood and                 of a cardiac defect may continue or in
                                                      result in impairment of the immune                      lead independent lives with little or no               other instances the problem may only
                                                      system’s ability to respond to infection,               difficulty. Others, however, may                       surface as an adult. If a cardiac defect
                                                      whereas TCE exposures during                            develop disability over time, making it                impacts a person’s ability to enter
                                                      adulthood result in a more pronounced                   difficult to predict and quantify                      certain careers, this could take a
                                                      immune effect related to autoimmune                     impacts.                                               monetary as well as emotional toll on
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                                                      responses.                                                 Even though a person’s heart defect                 that person and on their parents or
                                                         Cardiac defects, which can result from               may be repaired, for many people this                  families who may need to provide some
                                                      low-level exposure to TCE, affect the                   is not a cure. They can still develop                  form of financial support. The
                                                      structural development of a baby’s heart                other health problems over time,                       monetary, emotional, and mental costs
                                                      and how it works. The defects impact                    depending on their specific heart defect,              of heart defects can be considerable, and
                                                      how blood flows through the heart and                   the number of heart defects they have,                 even though neither the precise
                                                      out to the rest of the body. The impact                 and the severity of their heart defect.                reduction in individual risk of
                                                      can be mild (such as a small hole in the                For example, some related health                       developing a cardiac defect from
                                                      heart) or severe (such as missing or                    problems that might develop include                    reducing TCE exposure or the total


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                             7447

                                                      number of cases avoided can be                          occurs. The costs for hemodialysis, as                 many misdiagnosed or undiagnosed
                                                      estimated, their impact should be                       charged by hospitals, can be upwards of                cases (Ref. 46).
                                                      considered.                                             $100,000 per month (Ref. 44).                             Localized scleroderma is more
                                                         2. Kidney toxicity. a. Non-cancer                       Depending on the severity of the                    common in children, whereas systemic
                                                      chronic effects. The TCE risk assessment                kidney damage, kidney disease can                      scleroderma is more common in adults.
                                                      identified kidney toxicity as a                         impact a person’s ability to work and                  Overall, female patients outnumber
                                                      significant concern from TCE exposure                   live a normal life, which in turn takes                male patients about 4-to-1. Factors other
                                                      with the risk from this non-cancer effect               a mental and emotional toll on the                     than a person’s gender, such as race and
                                                      being from chronic exposure. There are                  patient. In less severe cases, the impact              ethnic background, may influence the
                                                      increased health risks for kidney                       on a person’s quality of life may be                   risk of getting scleroderma, the age of
                                                      toxicity to the approximately 2,670 to                  limited, while in instances where                      onset, and the pattern or severity of
                                                      6,270 workers and 42,720 to 100,320                     kidney damage is severe, a person’s                    internal organ involvement. The reasons
                                                      occupational bystanders in facilities that              quality of life and ability to work would              for this susceptibility are not clear.
                                                      use TCE for vapor degreasing, where                     be affected. While neither the precise                 Although scleroderma is not directly
                                                      exposure to TCE is a result of vapor                    reduction in individual risk of                        inherited, some scientists believe there
                                                      degreasing operations (Ref. 3).                         developing kidney toxicity from                        is a slight predisposition to it in families
                                                         Exposure to TCE can lead to changes                  reducing TCE exposure or the total                     with a history of rheumatic diseases
                                                      in the proximate tubules of the kidney.                 number of cases avoided can be                         (Ref. 46).
                                                      This damage may result in signs and                     estimated, these costs must still be                      The symptoms of scleroderma vary
                                                      symptoms of acute kidney failure that                   considered because they can                            greatly from person to person with the
                                                      include; decreased urine output,                        significantly impact those exposed to                  effects ranging from very mild to life
                                                      although occasionally urine output                      TCE.                                                   threatening. If not properly treated, a
                                                      remains normal; fluid retention, causing                   b. Cancer effects. Chronic exposure to              mild case can become much more
                                                      swelling in the legs, ankles or feet;                   TCE can also lead to kidney cancer. The                serious. Relatively mild symptoms are
                                                      drowsiness; shortness of breath, fatigue,               estimated value of the annualized                      localized scleroderma, which results in
                                                      confusion, nausea, seizures or coma in                  benefit is $12 million to $108 million at              hardened waxy patches on the skin of
                                                      severe cases; and chest pain or pressure.               3% and $6 million to $57 million at 7%                 varying sizes, shapes and color. The
                                                      Sometimes acute kidney failure causes                   over 20 years. Kidney cancer rarely                    more life threatening symptoms are
                                                      no signs or symptoms and is detected                    shows signs or symptoms in its early                   from systemic scleroderma, which can
                                                      through lab tests done for another                      stages. As kidney cancer progresses, the               involve the skin, esophagus,
                                                      reason.                                                 cancer may grow beyond the kidney,                     gastrointestinal tract (stomach and
                                                         Kidney toxicity means the kidney(s)                  spreading to lymph nodes or distant                    bowels), lungs, kidneys, heart and other
                                                      has suffered damage that can result in                  sites like the liver, lung or bladder,                 internal organs. It can also affect blood
                                                      a person being unable to rid their body                 increasing the impacts on a person and                 vessels, muscles and joints. The tissues
                                                      of excess urine and wastes. In extreme                  the costs to treat it. This metastasis is              of involved organs become hard and
                                                      cases where the kidney(s) is impaired                   highly correlated with fatal outcomes.                 fibrous, causing them to function less
                                                      over a long period of time, the kidney(s)               Impacts of kidney cancer that are not                  efficiently.
                                                      could be damaged to the point that it no                monetized include the emotional,                          Severe hypersensitivity skin disorders
                                                      longer functions. When a kidney(s) no                   psychological and treatment impacts of                 include exfoliative dermatitis, mucous
                                                      longer functions, a person needs                        the cancer on the well-being of the                    membrane erosions, eosinophilia, and
                                                      dialysis and ideally a kidney transplant.               person.                                                hepatitis. Exfoliative dermatitis is a
                                                      In some cases, a non-functioning                           3. Immunotoxicity. a. Non-cancer                    scaly dermatitis involving most, if not
                                                      kidney(s) can result in death. Kidney                   chronic effects. The TCE risk assessment               all, of the skin. Eosinophilia, on the
                                                      dialysis and kidney transplantation are                 identified immunotoxicity as a chronic                 other hand, is a chronic disorder
                                                      expensive and incur long-term health                    non-cancer effect that is associated with              resulting from excessive production of a
                                                      costs if kidney function fails (Ref. 42).               TCE exposure. There are increased                      particular type of white blood cells. If
                                                         Approximately 31 million people, or                  health risks for immunotoxicity to the                 diagnosed and treated early, a person
                                                      10% of the adult population, in the                     approximately 2,670 to 6,270 workers                   can lead a relatively normal life (Ref.
                                                      United States have chronic kidney                       and 42,720 to 100,320 bystanders                       45).
                                                      disease. In the United States, it is the                exposed to TCE as a result of vapor                       The monetary costs for treating these
                                                      ninth leading cause of death. About                     degreasing operations (Ref. 3).                        various immunotoxicity disorders will
                                                      93% of chronic kidney disease is from                      Human studies have demonstrated                     vary depending upon whether the
                                                      known causes, including 44% from                        that TCE exposed workers can suffer                    symptoms lead to early diagnosis and
                                                      diabetes and 28.4% from high blood                      from systemic autoimmune diseases                      this early diagnosis can then influence
                                                      pressure. Unknown or missing causes                     (e.g., scleroderma) and severe                         whether symptoms progress to mild or
                                                      account for about 6.5% of cases, or                     hypersensitivity skin disorders.                       life-threatening outcomes. For mild
                                                      about 2 million people (Ref. 43).                       Scleroderma is a chronic connective                    symptoms, doctors’ visits and outpatient
                                                         The monetary cost of kidney toxicity                 tissue disease with autoimmune origins.                treatment could be sufficient, while
                                                      varies depending on the severity of the                 The annual incidence is estimated to be                more severe immunotoxicity disorders,
                                                      damage to the kidney. In less severe                    10 to 20 cases per 1 million persons                   may require hospital visits. Treatments
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                                                      cases, doctor visits may be limited and                 (Ref. 45), and the prevalence is four to               for these conditions with immune
                                                      hospital stays unnecessary. In more                     253 cases per 1 million persons (Ref.                  modulating drugs also have
                                                      severe cases, a person may need serious                 46). About 300,000 Americans are                       countervailing risks.
                                                      medical interventions, such as dialysis                 estimated to have scleroderma. About                      These disorders also take an
                                                      or a kidney transplant if a donor is                    one third of those people have the                     emotional and mental toll on the person
                                                      available, which can result in high                     systemic form of scleroderma. Since                    as well as on their families. Their
                                                      medical expenses due to numerous                        scleroderma presents with symptoms                     quality of life may be impacted because
                                                      hospital and doctor visits for regular                  similar to other autoimmune diseases,                  they no longer have the ability to do
                                                      dialysis and surgery if a transplant                    diagnosis is difficult. There may be                   certain activities that may affect or


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                                                      7448                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      highlight their skin disorder, such as                  diagnosis and success and failure of a                 cases avoided can be estimated, the
                                                      swimming. Concerns over doctor and                      treatment regime. If a person has                      Agency still must consider their impact.
                                                      hospital bills, particularly if a person’s              children, this could affect their mental                  5. Neurotoxicity. The TCE risk
                                                      ability to work is impacted, may further                and emotional well-being and may                       assessment identified neurotoxicity
                                                      contribute to a person’s emotional and                  impact their success in school. The                    risks for workers and bystanders from
                                                      mental stress. While neither the precise                estimated value of the monetized benefit               chronic TCE exposures. There are
                                                      reduction in individual risk of                         is $32 million to $201 million at 3% and               increased health risks of neurotoxicity
                                                      developing this disorder from TCE                       $15 million to $98 million at 7%                       for the approximately 2,670 to 6,270
                                                      exposure or the total number of cases                   annualized over 20 years.                              workers and 42,720 to 100,320
                                                      avoided can be estimated, this should be                   4. Reproductive and endocrine effects.              occupational bystanders exposed to TCE
                                                      considered.                                             The TCE risk assessment identified risks               as a result of vapor degreasing
                                                         b. Cancer effects: Non-Hodgkin’s                     of chronic non-cancer reproductive                     operations (Ref. 3).
                                                      Lymphoma. EPA’s 2011 IRIS assessment                    effects for workers and bystanders                        Studies have also demonstrated
                                                      for TCE found that TCE is carcinogenic.                 exposed to TCE. There are increased                    neurotoxicity from acute exposures.
                                                      Chronic exposure to TCE, by all routes                  health risks for reproductive effects for              Neurotoxic effects observed include
                                                      of exposure, can result in non-Hodgkin’s                the approximately 2,670 to 6,270                       alterations in trigeminal nerve and
                                                      lymphoma (NHL), one of the three                        workers and 42,720 to 100,320                          vestibular function, auditory effects,
                                                      cancers for which the EPA IRIS TCE                      occupational bystanders exposed to TCE                 changes in vision, alterations in
                                                      assessment based its cancer findings.                   as a result of vapor degreasing                        cognitive function, changes in
                                                      There are increased health risks for NHL                operations (Ref. 3).                                   psychomotor effects, and
                                                      for the approximately 2,670 to 6,270                       The reproductive effect for both                    neurodevelopmental outcomes.
                                                      workers and 42,720 to 100,320                           females and males can be altered libido.               Developmental neurotoxicity effects
                                                      occupational bystanders exposed to TCE                  The prevalence of infertility is estimated
                                                                                                                                                                     include delayed newborn reflexes,
                                                      as a result of vapor degreasing                         at about 10–15% of couples with a
                                                                                                                                                                     impaired learning or memory,
                                                      operations (Ref. 3).                                    decreased libido among the factors of
                                                                                                                                                                     aggressive behavior, hearing
                                                         NHL is a form of cancer that                         infertility (Ref. 50). For females, there
                                                                                                                                                                     impairment, speech impairment,
                                                      originates in a person’s lymphatic                      can be reduced incidence of
                                                                                                                                                                     encephalopathy, impaired executive
                                                      system. For NHL, there are                              fecundability (6.7 million women ages
                                                                                                                                                                     and motor function and attention deficit
                                                      approximately 19.7 new cases per                        15 to 44 or 10.9% affected) (Ref. 51),
                                                                                                                                                                     (Ref. 4).
                                                      100,000 men and women per year with                     increase in abnormal menstrual cycles,
                                                      6.2 deaths per 100,000 men and women                    and amenorrhea (the absence of                            The impacts of neurotoxic effects due
                                                      per year. NHL is the seventh most                       menstruation). Reproductive effects on                 to TCE exposure can last a person’s
                                                      common form of cancer (Ref. 47). Some                   males can be decreased potency,                        entire lifetime. Changes in vision may
                                                      studies suggest that exposure to                        gynaecomastia, impotence, and                          impact a person’s ability to drive, which
                                                      chemicals may be linked to an increased                 decreased testosterone levels, or low T                can create difficulties for daily life.
                                                      risk of NHL. Other factors that may                     levels. Approximately 2.4 million men                  Impaired learning or memory,
                                                      increase the risk of NHL are medications                age 40 to 49 have low T levels, with a                 aggressive behavior, hearing
                                                      that suppress a person’s immune                         new diagnosis of about 481,000                         impairment, speech impairment,
                                                      system, infection with certain viruses                  androgen deficiency cases a year. Other                encephalopathy, impaired executive
                                                      and bacteria, or older age (Ref. 48).                   estimates propose a hypogonadism                       and motor function and attention deficit
                                                         Symptoms are painless, swollen                       prevalence of about 13 million                         can impact a child’s educational
                                                      lymph nodes in the neck, armpits or                     American men (Ref. 52). Low T levels                   progression and an adolescent’s
                                                      groin, abdominal pain or swelling, chest                are associated with aging; an estimated                schooling and ability to make friends,
                                                      pain, coughing or trouble breathing,                    39% of men 45 or older have                            which in turn can impact the type of
                                                      fatigue, fever, night sweats, and weight                hypogonadism, resulting in low T levels                work or ability to get work later in life.
                                                      loss. Depending on the rate at which the                (Ref. 53). Hormone therapy and                            Neurotoxicity in adults can affect the
                                                      NHL is advancing, the approach may be                   endocrine monitoring may be required                   trigeminal nerve, the largest and most
                                                      to monitor the condition, while more                    in the most severe cases.                              complex of the 12 cranial nerves, which
                                                      aggressive NHL could require                               The monetary costs of these potential               supplies sensations to the face, mucous
                                                      chemotherapy, radiation, stem cell                      reproductive effects involve doctor’s                  membranes, and other structures of the
                                                      transplant, medications that enhance a                  visits in order to try to determine a                  head. Onset of trigeminal neuralgia
                                                      person’s immune system’s ability to                     diagnosis. In some instances, a person                 generally occurs in mid-life and known
                                                      fight cancer, or medications that deliver               or couple may need to visit a fertility                causes include multiple sclerosis,
                                                      radiation directly to cancer cells.                     doctor.                                                sarcoidosis and Lyme disease. There is
                                                         Treatment for NHL will result in                        The impact of a reduced sex drive can               also a co-morbidity with scleroderma
                                                      substantial costs for hospital and                      take an emotional and mental toll on                   and systemic lupus. Some data show
                                                      doctors’ visits in order to treat the                   single people as well as couples. For                  that the prevalence of trigeminal
                                                      cancer. The treatments for NHL can also                 people trying to get pregnant, decreased               neuralgia could be between 0.01% and
                                                      have countervailing risks and can lead                  fertility can add stress to a relationship             0.3% (Ref. 54). Alterations to this nerve
                                                      to higher susceptibility of patients to                 as the cause is determined and avenues                 function might cause sporadic and
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                                                      secondary malignancies (Ref. 49). The                   explored to try to resolve the difficulties            sudden burning or shock-like facial pain
                                                      emotional and mental toll from                          in conceiving. A person or couples’                    to a person. One way to relieve the
                                                      wondering whether a treatment will be                   quality of life can also be affected as                burning or shock-like facial pain is to
                                                      successful, going through the actual                    they struggle with a reduced sex drive.                undergo a procedure where the nerve
                                                      treatment, and inability to do normal                   Similar to other non-cancer effects                    fibers are damaged in order to block the
                                                      activities or work will most likely be                  discussed previously, while neither the                pain. This treatment can have lasting
                                                      high. This emotional and mental toll                    precise reduction in individual risk of                impact on sensation which may also be
                                                      will extend to the person’s family and                  developing this disorder from reducing                 deleterious for normal pain sensation.
                                                      friends as they struggle with the                       TCE exposure or the total number of                    The potential side effects of this


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                             7449

                                                      procedure includes facial numbness and                  (NAFLD) (Ref. 55). NAFLD tends to                      metabolism, and liver disease.
                                                      some sensory loss.                                      impact people who are overweight/                      Symptoms of jaundice include yellow or
                                                         The monetary health costs can range                  obese or have diabetes. However, an                    itchy skin and a yellowing of the whites
                                                      from doctor’s visits and medication to                  estimated 25% do not have any risk                     of the eye, and a pale stool and dark
                                                      surgeries and hospital stays. Depending                 factors (Ref. 55). The danger of NAFLD                 urine. These symptoms can create a
                                                      upon when the neurotoxic effect                         is that it can cause the liver to swell,               heightened emotional state as a person
                                                      occurred, the monetary costs may                        which may result in cirrhosis over time                tries to determine what is wrong with
                                                      encompass a person’s entire lifetime or                 and could even lead to liver cancer or                 them.
                                                      just a portion.                                         failure (Ref. 55). The most common                        Depending upon the severity of the
                                                         The personal costs (emotional,                       known causes to this disease burden are                jaundice, treatments can range
                                                      mental, and impacts to a person’s                       attributable to alcoholism and viral                   significantly. Simple treatment may
                                                      quality of life) cannot be discounted.                  infections, such as hepatitis A, B, and C.             involve avoiding exposure to the TCE;
                                                      Parents of a child with impaired                        In 2013, there were 1,781 reported acute               however, this may impact a person’s
                                                      learning, memory, or some other                         cases of viral hepatitis A and the                     ability to continue to work. In severe
                                                      developmental neurotoxic effect may                     estimated actual cases were 3,500 (Ref.                cases, the liver toxicity can lead to liver
                                                      suffer emotional and mental stress                      56). For hepatitis B in 2013 there were                failure, which can result in the need for
                                                      related to worries about the child’s                    3,050 reported acute cases, while the                  a liver transplant, if a donor is available.
                                                      performance in school, ability to make                  estimated actual incidence was 19,800,                 Liver transplantation is expensive (with
                                                      friends, and quality of the child’s life                and the estimated chronic cases in the                 an estimated cost of $575,000) and there
                                                      because early disabilities can have                     United States is between 700,000 to 1.4                are countervailing risks for this type of
                                                      compounding effects as they grow into                   million (Ref. 56). For hepatitis C, in                 treatment (Ref. 57). The mental and
                                                      adulthood. The parent may need to take                  2013 there were 2,138 reported cases;                  emotional toll on an individual and
                                                      off work unexpectedly and have the                      however, the estimated incidence was                   their family as they try to determine the
                                                      additional cost of doctor visits and/or                 29,700 and the estimated number of                     cause of sickness and possibly
                                                      medication.                                             chronic cases is between 2.7 to 3.9                    experience an inability to work, as well
                                                         For a person whose trigeminal nerve                  million (Ref. 56). These known                         as the potential monetary cost of
                                                      is affected, there is an emotional and                  environmental risk factors of hepatitis                medical treatment required to regain
                                                      mental toll as they wonder what is                      infection may result in increased                      health are significant.
                                                      wrong and visit doctors in order to                     susceptibility of individuals exposed to
                                                      determine a diagnosis. Depending on                                                                            D. Availability of Alternatives
                                                                                                              organic chemicals. While the incidences
                                                      the severity of the impact to the nerve,                in this paragraph reflect adverse health                  TCE is commonly used in vapor
                                                      they may be unable to work. Doctor                      outcomes beyond just exposure to TCE,                  degreasing systems for a variety of
                                                      visits and any inability to work will                   the general population numbers provide                 reasons. It is able to dissolve the greases,
                                                      have a monetary impact to the person.                   a context for understanding the impact                 fats, oils, waxes, resins, gums and rosin
                                                      There are varying costs (emotional,                     of the adverse health effects that TCE                 fluxes generally used in metalworking
                                                      monetary, and impacts to a person’s                     can cause.                                             operations and it is compatible with
                                                      quality of life) from the neurotoxic                       Effects from TCE exposure to the liver              most metal substrates. TCE is non-
                                                      effects due to TCE exposure. However,                   can occur quickly. Liver weight increase               flammable and it has a relatively low
                                                      while neither the precise reduction in                  has occurred in mice after as little as 2              boiling point. It is also available at a
                                                      individual risk of developing this                      days of inhalation exposure (Ref. 4).                  relatively low cost. Several SERs
                                                      disorder from reducing TCE exposure or                  Human case reports from eight countries                providing input to the SBAR Panel
                                                      the total number of cases avoided can be                indicated symptoms of hepatitis,                       convened in support of this rulemaking
                                                      estimated, this is not a reason to                      hepatomegaly and elevated liver                        noted that TCE is particularly well-
                                                      disregard their impact.                                 function enzymes, and in rare cases,                   suited for use in vapor degreasing in the
                                                         6. Liver toxicity. The TCE risk                      acute liver failure developed within as                narrow tube, razor blade, and aerospace
                                                      assessment identified liver toxicity as an              little as 2–5 weeks of initial exposure to             industries (Ref. 32).
                                                      adverse effect of chronic TCE exposure.                 TCE (Ref. 4).                                             Nevertheless, EPA identified a wide
                                                      There are increased health risks for liver                 Chronic exposure to TCE can also                    variety of technically and economically
                                                      toxicity to the approximately 2,670 to                  lead to liver cancer. There is strong                  feasible alternatives for vapor
                                                      6,270 workers and 42,720 to 100,320                     epidemiological data that reported an                  degreasing with TCE. See Unit 4 of the
                                                      occupational bystanders exposed to TCE                  association between TCE exposure and                   Economic Analysis for a complete
                                                      as a result of vapor degreasing                         the onset of various cancers, including                discussion of the technically and
                                                      operations (Ref. 2).                                    liver cancer. The estimated value of the               economically feasible alternatives to
                                                         Specific effects to the liver can                    annualized benefit is estimated to be                  TCE. (Ref. 3). While some substitutes,
                                                      include increased liver weight, increase                $21 million to $133 million at 3% and                  such as methylene chloride or 1–BP,
                                                      in DNA synthesis (transient), enlarged                  $11 million to $71 million at 7% over                  also present risks to workers, there are
                                                      hepatocytes, enlarged nuclei, and                       20 years.                                              numerous other solvents available.
                                                      peroxisome proliferation (Ref. 2). In                      Additional medical and emotional                    These include designer solvents such as
                                                      addition, workers exposed to TCE have                   costs are associated with non-cancer                   hydrofluorocarbon (HFC) and
                                                      shown hepatitis accompanying                            liver toxicity from TCE exposure,                      hydrofluoroether (HFE) solvent blends
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                                                      immune-related generalized skin                         although they cannot be quantified.                    and hydrofluoroolefin (HFO), as well as
                                                      diseases, jaundice, hepatomegaly,                       These costs include doctor and hospital                other alternative solvents and cleaning
                                                      hepatosplenomegaly, and liver failure                   visits and medication costs. In some                   systems, such as terpene-based cleaners,
                                                      (Ref. 2).                                               cases, the ability to work can be                      volatile methyl siloxanes, soy-based
                                                         Some form of liver disease impacts at                affected, which in turn impacts the                    cleaners, and water-based cleaners.
                                                      least 30 million people, or 1 in 10                     ability to get proper ongoing medical                     Alternatives to TCE fall within several
                                                      Americans (Ref. 55). Included in this                   care. Liver toxicity can lead to jaundice,             broad categories: Drop-in solvent
                                                      number is at least 20% of those with                    weakness, fatigue, weight loss, nausea,                alternatives, non-drop-in solvent
                                                      nonalcoholic fatty liver disease                        vomiting, abdominal pain, impaired                     alternatives (designer solvents, such as


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                                                      7450                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

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


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                            7451

                                                      agent. In certain circumstances parts can               systems can be developed to replace                    timeframes for EPA action, given that
                                                      be sprayed at pressures of about 60 psi                 most TCE-based vapor degreasing                        the documentation for any given use
                                                      and greater in spray cabinets.                          systems (Ref. 32). This same SER also                  could be technical and extensive, and
                                                      Conveyorized spray systems, where the                   stated that potential drawbacks to                     that EPA may also need to develop
                                                      parts go through high pressure spray at                 aqueous cleaning systems are the                       additional information, such as
                                                      between about 80 and 120 psi, are also                  increased water use and the need for                   economic estimates, in order to
                                                      used in some cases. These systems often                 additional facility space. According to                promulgate an exemption rule under
                                                      have wash, rinse and dry sections.                      this SER, aqueous systems are typically                TSCA section 6(g). Finally, members of
                                                         Water-based cleaners have a few                      much larger than vapor degreasing                      the potentially regulated community
                                                      characteristics to consider when                        systems and aqueous operations often                   who believe that their operation is a
                                                      evaluating replacements for TCE vapor                   require multiple stages to reach the                   critical or essential use should provide
                                                      degreasing (Ref. 63). Since TCE is used                 same cleaning efficiency as vapor                      as much detail as possible to EPA about
                                                      primarily to clean metal parts, the water               degreasers.                                            their operation during this comment
                                                      cleaners often contain rust or corrosion                   Based on this input from the SERs,                  period, including information on any
                                                      inhibitors, which typically are present                 EPA is specifically requesting additional              evaluations of alternatives, the costs to
                                                      at very low concentrations, to protect                  comments, information, and data to                     transition to another chemical or
                                                      the metals (Ref. 61). In addition, in                   assist EPA in evaluating the availability              process, and any other relevant
                                                      order to be used in spray equipment,                    of alternatives to TCE in vapor                        information. This would assist EPA in
                                                      water-based cleaners must be                            degreasing applications, including                     reviewing the specific condition of use,
                                                      formulated with a non-foaming                                                                                  as well as in establishing provisions for
                                                                                                              information on the costs to achieve TCE
                                                      surfactant. However, there are numerous                                                                        future exemption petitions.
                                                                                                              exposure reductions or to transition to
                                                      water-based cleaners available on the                                                                             EPA urges vapor degreasing facilities
                                                                                                              alternative chemicals or processes. In
                                                      market that have been formulated for                                                                           to think strategically about their choices
                                                                                                              addition, EPA will consider granting a
                                                      these purposes (Ref. 64). In addition, the                                                                     should TCE be banned for their use or
                                                                                                              time-limited exemption, under the
                                                      SBAR Panel convened in support of this                                                                         if they are in the market to replace or
                                                                                                              authority of TSCA section 6(g), for a
                                                      rulemaking heard from several SERs                                                                             upgrade vapor degreasing equipment for
                                                                                                              specific condition of use for which EPA
                                                      about the increased water use associated                                                                       other reasons. To the extent that a
                                                                                                              can obtain documentation: That the
                                                      with aqueous cleaning systems (more                                                                            process currently using TCE in a vapor
                                                                                                              specific condition of use is a critical or             degreasing system can be converted to a
                                                      than 10,000 gallons a day). While this
                                                      water can be reused in the degreasing                   essential use for which no technically                 significantly less toxic alternative, such
                                                      system, any effluent is considered                      and economically feasible safer                        as an aqueous cleaning system, it will
                                                      industrial wastewater for which a                       alternative is available, taking into                  avoid significant risks to workers and
                                                      permit may be required under the Clean                  consideration hazard and exposure; that                also reduce the likelihood that further
                                                      Water Act (Ref. 32).                                    compliance with the proposed ban                       actions on toxic solvents by EPA or
                                                         SERs providing input to the SBAR                     would significantly disrupt the national               other regulatory authorities will spur
                                                      Panel noted that, in general the use of                 economy, national security, or critical                another process change.
                                                      TCE in vapor degreasing is declining                    infrastructure; or that TCE vapor
                                                      very rapidly in certain sectors, but is                 degreasing in a specific application, as               E. Impacts of the Proposed and
                                                      still the method of choice for some,                    compared to reasonably available                       Alternative Regulatory Options
                                                      especially for small, intricate parts and               alternatives, provides a substantial                     This unit describes the estimated
                                                      substrates (e.g., small tubes). Several                 benefit to health, the environment, or                 costs of the proposed and alternative
                                                      SERs contended that none of the                         public safety. To this end, EPA requests               regulatory actions that EPA considered.
                                                      currently available chemical alternatives               comment on a process for receiving and                   1. Proposed approach to prohibit
                                                      are good substitutes for TCE because of                 evaluating petitions and requesting EPA                manufacturing (including import),
                                                      the health hazards associated with the                  promulgate critical use exemption rules.               processing, distribution in commerce,
                                                      substitutes, potential upcoming                         Under this process, entities who believe               and use of TCE for vapor degreasing
                                                      regulations and use restrictions on                     that their specific condition of use is a              and require downstream notification.
                                                      substitutes, compliance with the                        critical or essential use under TSCA                   The costs of the proposed approach are
                                                      NESHAP limitations, and cost. In                        section 6(g) would submit a petition for               estimated to include equipment
                                                      addition, some degreasing applications                  an exemption rulemaking with                           modification costs, product costs,
                                                      require highly efficient cleaning, such as              supporting documentation that they                     electricity, disposal, and other costs
                                                      electronics and glass to metal seals,                   believe demonstrates that the use meets                associated with using alternative
                                                      which must be absolutely free of soil. A                the statutory criteria. EPA would review               solvents or systems. Although the
                                                      SER stated that no substitutes for critical             the petition for completeness and, if the              proposal imposes costs resulting from
                                                      glass to metal seals have been identified.              documentation warrants further action,                 downstream notification and
                                                      Several SERs stated that substitutes with               respond to the petition by publishing a                recordkeeping requirements, these
                                                      lower boiling points are not viable                     proposal in the Federal Register                       actions required under this proposed
                                                      alternatives because they volatilize                    inviting comment on a proposed                         rule are identical in requirement and
                                                      during processes involving elevated                     exemption. EPA would consider the                      coverage to those included as part of the
                                                      temperatures and because they cannot                    comments received, along with any                      earlier proposed rule on TCE use in
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                                                      be shipped in standard drums. Most                      additional information reasonably                      aerosol degreasing and spot cleaning at
                                                      SERs indicated that replacing their                     available, and then take final action on               dry cleaning facilities (Ref. 1) that is a
                                                      open-top vapor degreasing systems with                  the proposed exemption. EPA requests                   companion to this proposed rule. These
                                                      more sophisticated systems or                           comment on the specific kinds of                       notification and recordkeeping costs
                                                      alternative systems using aqueous                       documentation that should be required                  were accounted for as part of that
                                                      cleaners would be very expensive,                       from entities seeking an exemption                     proposal and are not included in the
                                                      estimates ranged from $350,000 to                       rulemaking in order to facilitate EPA’s                costs for this rule. Overall, EPA
                                                      $650,000. In contrast, one SER noted                    and later, the public’s review. EPA also               estimates that 50% of users will switch
                                                      that water-based, or aqueous cleaning                   requests comment on the appropriate                    to drop-in alternatives, 25% will


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                                                      7452                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      convert to aqueous cleaning systems,                    the greatest extent the potential for TCE              calculate the number of cases avoided,
                                                      and 25% will convert to other                           products to be intentionally or                        EPA may not be able to monetize the
                                                      alternatives. The total costs for                       unintentionally misdirected into the                   benefits of these avoided cases due to
                                                      switching from TCE-based vapor                          prohibited uses. Enforcement under the                 limitations in data needed to apply
                                                      degreasing to a substitute are estimated                other options would be more difficult                  established economic methodologies.
                                                      to be approximately $30 million to $45                  since the key requirements are directly                However, being unable to quantitatively
                                                      million per year (annualized at 3% over                 placed on the larger number of product                 assess individual risk and population-
                                                      20 years) and $32 million to $46 million                users. Under these other options,                      level non-cancer cases avoided from
                                                      (annualized at 7% over 20 years).                       enforcement activities must target firms               TCE exposure does not negate the
                                                         2. Option that bans manufacturing                    that might perform the activity where a                impact of these effects. Similarly, the
                                                      (including import), processing,                         TCE use is restricted or prohibited.                   inability to monetize an adverse effect
                                                      distribution in commerce, and use of                    Therefore, EPA considers downstream                    does not reflect the severity of the effect,
                                                      TCE for vapor degreasing except in                      notification to be a critical component                the lifetime nature of the impact, or the
                                                      airless vacuum-to-vacuum closed-loop                    of this proposal and EPA also finds that               magnitude of the benefit in preventing
                                                      systems where proper PPE is used and                    incorporating downstream notification
                                                      a requirement for downstream                                                                                   the adverse impact from TCE exposure,
                                                                                                              reduces the burden on society by easing
                                                      notification. Given equipment costs and                                                                        such as a cardiac malformation, on a
                                                                                                              implementation, compliance, and
                                                      the burden of establishing a respiratory                                                                       person. In considering the benefits of
                                                                                                              enforcement.
                                                      protection program which involves                                                                              preventing TCE exposure, EPA
                                                      training, respirator fit testing and the                VII. Monetized Benefits and Costs of the               considered the type of effect, the
                                                      establishment of a medical monitoring                   Proposed Rule, the Alternatives EPA                    severity of the effect, the duration of the
                                                      program, EPA anticipates that                           Considered, and Comparison of                          effect, and costs and other monetary
                                                      companies not currently using airless                   Benefits and Costs                                     impacts of the health endpoint.
                                                      vacuum-to-vacuum systems would                             The health endpoints associated with                   The alternative options that EPA
                                                      choose to switch to substitutes instead                 TCE exposure are serious. The following                considered are unlikely to result in the
                                                      of purchasing an airless system and                     is a discussion of the impacts of the                  same health benefits as the proposed
                                                      adopting a program for PPE because                      most significant cancer and non-cancer                 rule for the reasons discussed in Unit
                                                      substitutes are readily available and are               effects associated with TCE exposure,                  VI. However, EPA was unable to
                                                      more technically and economic feasible.                 including the severity of the effect, the              quantify the differences in benefits that
                                                      EPA also assumes that this would be the                 manifestation of the effect, and how the               would result from the alternatives.
                                                      case even if this alternative were                      effect impacts a person during their
                                                      expressed as a performance-based air                    lifetime.                                              B. Costs of the Proposed Rule and the
                                                      exposure limit for TCE. The estimated                                                                          Alternatives That EPA Considered
                                                                                                              A. Benefits of the Proposed Rule and the
                                                      annualized costs of switching to a                      Alternatives That EPA Considered
                                                      respiratory protection program requiring                                                                         The details of the costs of the
                                                      PPE of APF 10,000 are $30,000 at 3%                        The risk reduction from preventing                  proposed approach for use of TCE in
                                                      and $32,000 at 7% per vapor degreasing                  TCE exposure cannot be                                 vapor degreasing are discussed in Unit
                                                      machine over 20 years. In addition,                     comprehensively quantified or                          VI.C. Under the proposed option, costs
                                                      there would be higher EPA                               monetized even though the adverse                      to users of TCE in vapor degreasing
                                                      administration and enforcement costs                    effects are well-documented, the TCE                   applications range from $30 million to
                                                      with respiratory protection program                     risk assessment estimating these risks                 $45 million (annualized at 3% over 20
                                                      than there would be with an                             has been peer-reviewed, and the                        years) and $32 million to $46 million
                                                      enforcement program under the                           benefits of reducing the risk of these                 (annualized at 7% over 20 years). Costs
                                                      proposed approach. Further, even if cost                health endpoints can be described. It is               of downstream notification and
                                                      were not an impediment, there are many                  relatively straightforward to monetize                 recordkeeping for manufacturers,
                                                      limitations to the successful                           the benefits of reducing the risk of the               processors, and distributors on an
                                                      implementation of respirators with an                   costs of the effects of cancer (kidney                 annualized basis over 20 years are
                                                      APF of 10,000 in a workplace.                           cancer, liver cancer, non-Hodgkin’s                    $3,200 and $4,400 using 3% and 7%
                                                         3. Options that exclude downstream                   lymphoma) due to TCE exposure. The                     discount rates respectively. However,
                                                      notification. For those options that                    estimated value of the annualized                      the costs of the downstream notification
                                                      exclude downstream notification, the                    benefit is estimated to be $65 million to              and recordkeeping requirements were
                                                      options are less cost effective and more                $447 million at 3% and $32 million to                  already accounted for in the prior
                                                      burdensome to enforce. This is even                     $227 million at 7% over 20 years. It is                proposal on TCE use in aerosol
                                                      though EPA assumes monetized                            currently not possible to monetize the                 degreasing and as a spotting agent in
                                                      enforcement costs to be the same under                  benefits of reducing the risks of the                  dry-cleaning facilities, and thus are not
                                                      all options for the purpose of this                     costs of non-cancer effects (all                       included in the total costs for this
                                                      proposed rulemaking because EPA was                     developmental toxicity, kidney toxicity,
                                                                                                                                                                     proposal.
                                                      unable to monetize the extent to which                  immunotoxicity, reproductive toxicity,
                                                      enforcement costs would vary by                         neurotoxicity, and liver toxicity) of TCE                The primary alternative that EPA
                                                      regulatory option. The proposed                         exposure. There are two reasons for this.              considered is a requirement that TCE be
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      approach to prohibit manufacturing                      First, dose response information and                   used for vapor degreasing only in
                                                      (including import), processing,                         concentration response functions in                    certain closed systems and that workers
                                                      distribution in commerce, and use of                    humans are not available. This                         operating the systems and in the
                                                      TCE for vapor degreasing and require                    information would allow EPA to                         immediate area wear PPE with an APF
                                                      downstream notification is relatively                   estimate the number of population-level                of 10,000. The estimated annualized
                                                      easy to enforce because key                             non-cancer cases that would be avoided                 costs of this option are $32 million to
                                                      requirements are directly placed on a                   by reducing exposures to levels                        $46 million annualized over 20 years at
                                                      small number of suppliers and because                   corresponding with MOE benchmarks.                     3% and $34 million to $47 million
                                                      the supply chain approach minimizes to                  Second, even it were possible to                       annualized over 20 years at 7%.


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                             7453

                                                      C. Comparison of Benefits and Costs                     subsequently monetized (risk of                        benefits are most pronounced in
                                                         The monetized benefits for preventing                developmental toxicity, kidney toxicity,               estimating the benefits from preventing
                                                      the risks resulting from TCE exposure                   immunotoxicity, reproductive toxicity,                 the non-cancer adverse effects because
                                                      from this use significantly outweigh the                neurotoxicity, and liver toxicity),                    these benefits generally cannot be
                                                      estimated costs. Simply comparing the                   including benefits related to the severity             monetized due to the lack of
                                                      costs and monetized benefits of                         of the effects and the impacts on a                    concentration-response functions in
                                                      prohibiting the manufacture (including                  person throughout her/his lifetime in                  humans leading to the ability to
                                                      import), processing, and distribution in                terms of medical costs, effects on                     estimate the number of population-level
                                                      commerce of TCE for use in vapor                        earning power and personal costs, and                  non-cancer cases and limitations in
                                                      degreasing, prohibiting commercial use                  the emotional and psychological costs,                 established economic methodologies.
                                                                                                              the benefits of preventing exposures to                Additional uncertainties in benefit
                                                      of TCE in vapor degreasing, and
                                                                                                              TCE emissions from vapor degreasing                    calculations include the potential risks
                                                      requiring downstream notification
                                                                                                              systems outweigh the costs. Further, if                for adverse health effects that the
                                                      demonstrates that the monetized
                                                                                                              EPA were to consider only the benefits                 alternatives may pose and the estimates
                                                      benefits of this proposed action
                                                                                                              that can be monetized in comparison to                 of the alternatives that users might
                                                      outweigh the costs. However, EPA
                                                                                                              the cost, the monetized benefits from                  choose to adopt. While there are some
                                                      believes that the balance of costs and
                                                                                                              preventing kidney and liver cancer and                 products that have comparable risks,
                                                      benefits cannot be fairly described
                                                                                                              non-Hodgkin’s lymphoma from the use                    there are a number of alternatives that
                                                      without considering the additional, non-
                                                                                                              of TCE in vapor degreasing (the                        are likely to be of lower risk, although
                                                      monetized benefits of mitigating the
                                                                                                              annualized monetized benefits on a 20                  EPA is unable to estimate the
                                                      non-cancer adverse effects as well as                   year basis range from approximately $65
                                                      cancer. As discussed previously, the                                                                           incremental change in the risk. To
                                                                                                              million to $447 million at 3% and $32                  account for this uncertainty, EPA
                                                      multitude of potential adverse effects                  million to $227 million at 7%) far
                                                      associated with TCE exposure can                                                                               includes a lower and a higher estimate
                                                                                                              outweigh the costs of the proposal to                  for the benefits from eliminating
                                                      profoundly impact an individual’s                       ban the use of TCE in vapor degreasing
                                                      quality of life. Some of the adverse                                                                           exposure to TCE. The lower benefits
                                                                                                              (the annualized costs on a 20 year basis               estimate assumes no benefits for TCE
                                                      effects associated with TCE exposure                    range from approximately $30 million to
                                                      can be immediately experienced and                                                                             users that keep the same vapor
                                                                                                              $45 million at 3% and $32 million to                   degreasing machines and switch to
                                                      can affect a person from childhood                      $46 million at 7%). Considering the
                                                      throughout a lifetime (e.g., cardiac                                                                           methylene chloride, perchloroethylene,
                                                                                                              costs and benefits of the proposed and                 1–BP, or designer solvent alternatives,
                                                      malformations, developmental                            alternative options, while both address
                                                      neurotoxicity, and developmental                                                                               assumes that TCE users switching to any
                                                                                                              the unreasonable risks from TCE                        other alternative suffer no adverse
                                                      immunotoxicity). Others (e.g., adult                    exposure, the proposed approach is
                                                      immunotoxicity, kidney and liver                                                                               health effects associated with the
                                                                                                              more cost effective because it achieves                alternatives (i.e., accrue the full benefits
                                                      failure or cancers) can have impacts that               the same or greater benefits at lower
                                                      are experienced for a shorter portion of                                                                       from eliminating TCE exposure), and
                                                                                                              costs. For more information, see Section               applies a lowering factor to cancer risk
                                                      life, but are nevertheless significant in               7 in the Economic Analysis.
                                                      nature.                                                                                                        estimates. The higher benefits estimate
                                                         While the risk of non-cancer health                  VIII. Overview of Uncertainties                        includes the benefit from entirely
                                                      effects associated with TCE exposure                       A discussion of the uncertainties                   eliminating TCE exposure for all
                                                      cannot be quantitatively estimated, the                 associated with this proposed rule can                 alternative compliance strategies,
                                                      qualitative discussion in this Unit                     be found in the TCE risk assessment                    assumes that no risks are introduced by
                                                      highlights how some of these non-                       (Ref. 2) and in the supplemental                       alternatives, and does not apply a
                                                      cancer effects occurring much earlier in                analysis (Ref. 30) for use of TCE in                   lowering factor to cancer risk estimates.
                                                      life from TCE exposure may be as severe                 vapor degreasing. A summary of these                   This inability to adequately account for
                                                      as cancer’s mortality and morbidity and                 uncertainties follows.                                 adverse health effects of alternatives in
                                                      thus just as life-altering. These effects                  EPA used a number of assumptions in                 the benefits analysis is expected to
                                                      include not only medical costs but also                 the TCE risk assessment and supporting                 contribute most to the uncertainty in the
                                                      personal costs such as emotional and                    analysis to develop estimates for                      estimates.
                                                      mental stress that are impossible to                    occupational exposure scenarios and to                    In addition, under certain
                                                      accurately measure.                                     develop the hazard/dose-response and                   assumptions EPA’s economic analysis
                                                         While the impacts of non-cancer                      risk characterization. EPA recognizes                  estimates that some TCE users will see
                                                      effects cannot be monetized, EPA                        that the uncertainties may                             a cost savings when switching to
                                                      considered the impacts of these effects                 underestimate or overestimate actual                   aqueous systems and certain other
                                                      in deciding how best to address the                     risks. These uncertainties include the                 solvents. Standard economic theory
                                                      unreasonable risks presented by TCE                     possibility that releases of and                       suggests that financially rational
                                                      use in vapor degreasing. Considering                    exposures to TCE vary from one vapor                   companies would choose technologies
                                                      only monetized benefits would                           degreasing machine to the next. EPA                    that maximize profits so that regulatory
                                                      significantly underestimate the impacts                 attempted to quantify this uncertainty                 outcomes would not typically result in
                                                      of TCE-induced non-cancer adverse                       by evaluating multiple scenarios to                    a cost savings for the regulated facilities.
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      outcomes on a person’s quality of life to               establish a range of releases and                      There could be several reasons that cost
                                                      perform basic skills of daily living,                   exposures. In estimating the risk from                 savings might occur in the real world.
                                                      including the ability to earn a living, the             vapor degreasing, there are uncertainties              Potential reasons include lack of
                                                      ability to participate in sports and other              in the number of workers exposed to                    complete information or barriers to
                                                      activities, and the impacts on a person’s               TCE and in the inputs and algorithms of                obtaining information on the cost
                                                      family and relationships.                               the models used to estimate exposures.                 savings associated with alternatives as
                                                         Thus, considering costs, benefits that                  In addition to the uncertainties in the             well as investment barriers or higher
                                                      can be monetized (risk of cancer), and                  risks, there are uncertainties in the cost             interest rates faced by firms.
                                                      benefits that cannot be quantified and                  and benefits. The uncertainties in the                 Additionally, there may be costs


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                                                      7454                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      associated with these alternatives that                 the Administrator must submit a report                 example, OSHA may set exposure limits
                                                      are not adequately accounted for in the                 to the agency administering that other                 for workers but its authority is limited
                                                      analysis. To evaluate the effect of this                law that describes the risk and the                    to the workplace and does not extend to
                                                      uncertainty, EPA has included a                         activities that present such risk. If the              consumer uses of hazardous chemicals.
                                                      sensitivity analysis that sets the cost                 other agency responds by declaring that                Further, OSHA does not have direct
                                                      savings to zero for these compliance                    the activities described do not present                authority over state and local
                                                      alternatives (Ref. 3 at section 8.2). EPA               an unreasonable risk or if that agency                 employees, and it has no authority at all
                                                      also recognizes that these firms might                  initiates action under its own law to                  over the working conditions of state and
                                                      experience positive costs of compliance                 protect against the risk within the                    local employees in states that have no
                                                      rather than zero costs, so that the actual              timeframes specified by TSCA section                   OSHA-approved State Plan under 29
                                                      total costs could be higher than those in               9(a), EPA is precluded from acting                     U.S.C. 667. Other Federal regulatory
                                                      the sensitivity analysis. However, EPA                  against the risk under sections 6(a) or 7              authorities, such as CPSC, have the
                                                      has no current basis to estimate these                  of TSCA.                                               authority to only regulate pieces of the
                                                      potentially higher costs, since the                        TSCA section 9(d) instructs the                     risks posed by TCE, such as when used
                                                      available data appear to show that there                Administrator to consult and coordinate                in consumer products.
                                                      are lower cost substitutes available. EPA               TSCA activities with other Federal                        Moreover, recent amendments to
                                                      requests comment and/or data on any                     agencies for the purpose of achieving                  TSCA, Public Law 114–182, alter both
                                                      hidden costs that may be missing from                   the maximum enforcement of TSCA                        the manner of identifying unreasonable
                                                      the analysis, or any other information                  while imposing the least burden of                     risk under TSCA and EPA’s authority to
                                                      that may help explain why some firms                    duplicative requirements. For this
                                                                                                                                                                     address unreasonable risk under TSCA,
                                                      appear to be missing current                            proposed rule, EPA has consulted with
                                                                                                                                                                     such that risk management under TSCA
                                                      opportunity for cost-savings substitutes.               OSHA.
                                                                                                                 OSHA assures safe and healthful                     is increasingly distinct from analogous
                                                         There are also uncertainties in the                                                                         provisions of the Consumer Product
                                                      estimates of the number of affected                     working conditions for working men
                                                                                                              and women by setting and enforcing                     Safety Act (CPSA), the Federal
                                                      vapor degreasing machines, and for                                                                             Hazardous Substances Act, or the OSH
                                                      numbers of processors and distributors                  standards and by providing training,
                                                                                                              outreach, education and assistance.                    Act. These changes to TSCA reduce the
                                                      of TCE-containing products not                                                                                 likelihood that an action under the
                                                      prohibited by the proposed rule who are                 OSHA adopted an eight-hour time
                                                                                                              weighted average PEL of 100 ppm along                  CPSA, FHSA, or the OSH Act would
                                                      required to provide downstream                                                                                 reduce the risk of TCE from these uses
                                                      notification and/or maintain records.                   with a ceiling limit in 1971 shortly after
                                                                                                              the agency was formed. It was based on                 to a sufficient extent under TSCA.
                                                      The estimate for number of facilities                                                                          Whereas (in a TSCA section 6 rule) an
                                                      using TCE-containing vapor degreasing                   the ACGIH recommended occupational
                                                                                                              exposure limit that was in place at that               unreasonable risk determination sets the
                                                      machines is based upon available                                                                               objective of the rule in a manner that
                                                      industry information and an industry                    time. OSHA recognizes that the TCE
                                                                                                              PEL and many other PELs issued shortly                 excludes cost considerations, 15 U.S.C
                                                      expert (Ref. 3). To estimate the number                                                                        2605(b)(4)(A), subject to time-limited
                                                      of processors, EPA relied on public 2012                after adoption of the OSHA Act in 1970
                                                                                                              are outdated and inadequate for                        conditional exemptions for critical
                                                      CDR data. The number of sites is                                                                               chemical uses and the like, 15 U.S.C.
                                                      reported in the CDR data as a range. The                ensuring protection of worker health.
                                                                                                              OSHA recently published a Request for                  2605(g), a consumer product safety rule
                                                      midpoint of the reported ranges was                                                                            under the CPSA must include a finding
                                                                                                              Information on approaches to updating
                                                      used to estimate the total number of                                                                           that ‘‘the benefits expected from the rule
                                                                                                              PELs and other strategies to managing
                                                      sites using the chemical. Furthermore,                                                                         bear a reasonable relationship to its
                                                                                                              chemicals in the workplace (Ref. 12).
                                                      the CDR data only includes processors                                                                          costs.’’ 15 U.S.C. 2058(f)(3)(E).
                                                                                                              OSHA’s current regulatory agenda does
                                                      immediately downstream of those                                                                                Additionally, recent amendments to
                                                                                                              not include revision to the TCE PEL or
                                                      reporting to CDR. Finally, EPA                                                                                 TSCA reflect Congressional intent to
                                                                                                              other regulations addressing the risks
                                                      estimated the number of wholesaler                                                                             ‘‘delete[] the paralyzing ‘least
                                                                                                              EPA has identified when TCE is used in
                                                      firms distributing products containing                                                                         burdensome’ requirement,’’ 162 Cong.
                                                                                                              vapor degreasing or the uses identified
                                                      TCE by taking a ratio of the number of                                                                         Rec. S3517 (June 7, 2016). However, a
                                                                                                              in a prior proposal (Ref. 1), aerosol
                                                      Chemical and Allied Products Merchant                   degreasing or for spot cleaning in dry                 consumer product safety rule under the
                                                      Wholesaler firms to Basic Chemical                      cleaning facilities (Ref. 12).                         CPSA must impose ‘‘the least
                                                      Manufacturing firms and applying it to                     This proposed rule and the related                  burdensome requirement which
                                                      the estimated number of manufacturers                   proposal (Ref. 1), which EPA intends to                prevents or adequately reduces the risk
                                                      and processors of TCE (Ref. 3).                         finalize together, address risks in both               of injury for which the rule is being
                                                         EPA will consider additional                         workplace (both private- and public-                   promulgated.’’15 U.S.C. 2058(f)(3)(F).
                                                      information received during the public                  sector) and consumer settings from                     Analogous requirements, also at
                                                      comment period. This includes public                    exposure to TCE in vapor degreasers,                   variance with recent revisions to TSCA,
                                                      comments, scientific publications, and                  aerosol spray degreasers, and as a spot                affect the availability of action under the
                                                      other input submitted to EPA during the                 cleaner at dry cleaning facilities. With               FHSA relative to action under TSCA. 15
                                                      comment period.                                         the exception of TSCA, there is no                     U.S.C. 1262. Gaps also exist between
                                                      IX. Analysis Under TSCA Section 9 and                   Federal law that provides authority to                 OSHA’s authority to set workplace
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                                                      TSCA Section 26(h) Considerations                       prevent or sufficiently reduce these                   standards under the OSH Act and EPA’s
                                                                                                              cross-cutting exposures. No other                      amended obligations to sufficiently
                                                      A. TSCA Section 9(a) Analysis                           Federal regulatory authority, when                     address chemical risks under TSCA. To
                                                        Section 9(a) of TSCA provides that, if                considering the exposures to the                       set PELs for chemical exposure, OSHA
                                                      the Administrator determines in her                     populations and within the situations in               must first establish that the new
                                                      discretion that an unreasonable risk may                its purview, can evaluate and address                  standards are economically feasible and
                                                      be prevented or reduced to a sufficient                 the totality of the risk that EPA is                   technologically feasible. 79 FR 61387
                                                      extent by an action taken under a                       addressing in this proposal and the                    (2014). But under TSCA, EPA’s
                                                      Federal law not administered by EPA,                    prior proposal on TCE uses (Ref. 1). For               substantive burden under TSCA § 6(a) is


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                           7455

                                                      to demonstrate that, as regulated, the                  processing, and distribution in                        A. Prohibitions on TCE Manufacturing
                                                      chemical substance no longer presents                   commerce, and use of chemical                          (Including Import), Processing,
                                                      an unreasonable risk, with unreasonable                 substances.                                            Distribution in Commerce, and
                                                      risk being determined without                              For these reasons, the Administrator                Commercial Use
                                                      consideration of cost or other nonrisk                  does not determine that unreasonable                      This proposal would prohibit the
                                                      factors.                                                risks from the use of TCE in vapor                     manufacture (including import),
                                                         TSCA is the only regulatory authority                degreasers, aerosol spray degreasers,                  processing, distribution in commerce,
                                                      able to prevent or reduce risks from                    and as a spot cleaner at dry cleaning                  and commercial use of TCE in vapor
                                                      these uses of TCE to a sufficient extent                facilities could be eliminated or reduced              degreasing.
                                                      across the range of uses and exposures                  to a sufficient extent by actions taken
                                                      of concern. In addition, these risks can                under other Federal laws administered                  B. Downstream Notification
                                                      be addressed in a more coordinated,                     in whole or in part by EPA.                               EPA has authority under TSCA
                                                      efficient and effective manner under                                                                           section 6 to require that a substance or
                                                      TSCA than under two or more different                   C. Section 26(h) Considerations
                                                                                                                                                                     mixture or any article containing such
                                                      laws implemented by different agencies.                    EPA has used scientific information,                substance or mixture be marked with or
                                                      Furthermore, there are key differences                  technical procedures, measures,                        accompanied by clear and adequate
                                                      between the newly amended finding                       methods, protocols, methodologies, and                 warnings and instructions with respect
                                                      requirements of TSCA and those of the                   models consistent with the best                        to its use, distribution in commerce, or
                                                      OSH Act, CPSA, and the FHSA. For                        available science. For example, EPA                    disposal or with respect to any
                                                      these reasons, in her discretion, the                   based its proposed determination of                    combination of such activities. Many
                                                      Administrator does not determine that                   unreasonable risk presented by the use                 TCE manufacturers and processors are
                                                      unreasonable risks from the use of TCE                  of TCE in vapor degreasing systems on                  likely to manufacture or process TCE or
                                                      in vapor degreasers, aerosol spray                      the completed risk assessment, which                   TCE containing products for other uses
                                                      degreasers, and as a spot cleaner at dry                followed a peer review and public                      that would not be regulated under this
                                                      cleaning facilities may be prevented or                 comment process, as well as using the                  proposal. Other companies may be
                                                      reduced to a sufficient extent by an                    best available science and methods (Ref.               strictly engaged in distribution in
                                                      action taken under a Federal law not                    2). A supplemental analysis was                        commerce of TCE, without any
                                                      administered by EPA.                                    performed to better characterize the                   manufacturing or processing activities,
                                                      B. TSCA Section 9(b) Analysis                           exposed populations and estimate the                   to customers for uses that are not
                                                         If EPA determines that actions under                 effects of various control options. This               regulated. As discussed in the prior
                                                      other Federal laws administered in                      supplemental analysis was performed                    proposal on TCE use in aerosol
                                                      whole or in part by EPA could eliminate                 consistent with the methods and models                 degreasers and as a spot remover agent
                                                      or sufficiently reduce an unreasonable                  used in the risk assessment. These                     in dry cleaning facilities, EPA is
                                                      risk, section 9(b) of TSCA instructs EPA                analyses were developed for the                        proposing a requirement for
                                                      to use these other authorities unless the               purpose of determining whether the                     downstream notification by
                                                      Administrator determines in the                         particular risks are unreasonable. They                manufacturers (including importers),
                                                      Administrator’s discretion that it is in                were also developed to support risk                    processors, and distributors of TCE for
                                                      the public interest to protect against                  reduction by regulation under section 6                any use to ensure compliance with the
                                                      such risk under TSCA. In making such                    of TSCA, to the extent risks were                      proposed prohibitions on the
                                                      a public interest finding, TSCA section                 determined to be unreasonable. It is                   manufacture, processing, distribution in
                                                      9(b)(2) states: ‘‘the Administrator shall               reasonable and consistent to consider                  commerce, and commercial use of TCE.
                                                      consider, based on information                          these analysis in this rulemaking for                  Downstream notification is necessary
                                                      reasonably available to the                             such relevant purposes.                                for effective enforcement of the rule
                                                      Administrator, all relevant aspects of                     The extent to which the various                     because it provides a record, in writing,
                                                      the risk . . . and a comparison of the                  information, procedures, measures,                     of notification on use restrictions
                                                      estimated costs and efficiencies of the                 methods, protocols, methodologies or                   throughout the supply chain, likely via
                                                      action to be taken under this title and                 models, as applicable, used in EPA’s                   modifications to the Safety Data Sheet.
                                                      an action to be taken under such other                  decision have been subject to                          Downstream notification also increases
                                                      law to protect against such risk.’’                     independent verification or peer review                awareness of restrictions on use, which
                                                         Although several EPA statutes have                   is adequate to justify their use,                      is likely to decrease unintentional uses
                                                      been used to limit TCE exposure, as                     collectively, in the record for this rule.             of TCE. Downstream notification
                                                      discussed in Unit III.A., regulations                   Additional information on the peer                     represents minimal burden and is
                                                      under these EPA statutes have                           review and public comment process,                     necessary for effective enforcement of
                                                      limitations because they largely regulate               such as the peer review plan, the peer                 the rule. The specific requirement, that
                                                      releases to the environment, rather than                review report, and the Agency’s                        persons who manufacture (including
                                                      direct human exposure. SDWA only                        response to comments, can be found on                  import), process, or distribute in
                                                      applies to drinking water. CAA does not                 EPA’s Assessments for TSCA Work Plan                   commerce TCE for any use would have
                                                      apply directly to worker exposures or                   Chemicals Web page at https://                         to provide written notification of the
                                                      consumer settings where TCE is used.                    www.epa.gov/assessing-and-managing-                    restrictions to persons to whom TCE is
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                                                      Under RCRA, TCE that is discarded may                   chemicals-under-tsca/assessments-tsca-                 shipped, was included in an earlier
                                                      be considered a hazardous waste and                     work-plan-chemicals.                                   proposal on TCE use (Ref. 1). The
                                                      subject to requirements designed to                                                                            specific recordkeeping requirements
                                                                                                              X. Major Provisions and Enforcement of
                                                      reduce exposure from the disposal of                                                                           were also contained in the prior
                                                                                                              the Proposed Rule
                                                      TCE to air, land and water. RCRA does                                                                          proposal (Ref. 1). Those provisions
                                                      not address exposures during use of                       This proposal relies on general                      would require manufacturers (including
                                                      products containing TCE. Only TSCA                      provisions in the proposed Part 751,                   importers), processors, and distributors
                                                      provides EPA the authority to regulate                  Subpart A, which can be found at 81 FR                 of TCE for any use to retain
                                                      the manufacture (including import),                     91592 (December 16, 2016).                             documentation of the identity and


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                                                      7456                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                      contact information for persons to                      manufacturing (including importing),                   switching to less hazardous cleaners.
                                                      whom TCE was shipped as well as the                     processing, or distributing in commerce                EPA is particularly interested in
                                                      amount of TCE shipped, and a copy of                    TCE for vapor degreasing uses, the                     comments and information on water
                                                      the notification that was provided. This                downstream notification requirements,                  and energy use associated with water-
                                                      documentation would have to be                          and the recordkeeping requirements                     based cleaners and other less-toxic
                                                      retained for 3 years from the date of                   effective 18 months after publication of               solvents, as well as on the costs of
                                                      shipment.                                               the final rule. The ban on the use of TCE              conversion from a system that uses TCE
                                                        As presented in the prior proposal                    in vapor degreasing systems would take                 and the length of time such a conversion
                                                      (Ref. 1), the estimated costs of                        effect six months after that, or two years             would take.
                                                      downstream notification and                             after publication of the final rule. EPA                  EPA is also requesting comment on
                                                      recordkeeping on an annualized basis                    heard from the SERs who provided                       potential incentives for vapor
                                                      over 20 years are $3,200 and $4,400                     input to the SBAR Panel that converting                degreasing facilities to switch to less
                                                      using 3% and 7% discount rates                          from a vapor degreasing system that                    toxic alternatives. TSCA does not
                                                      respectively.                                           uses TCE to one that does not is often                 provide the authority for EPA to offer
                                                      C. Enforcement                                          a time-intensive process (Ref. 32). SERs               incentives such as tax credits, so there
                                                                                                              had different ideas on how long it                     are a limited number of regulatory
                                                         TSCA section 15 makes it unlawful to                 would take for the conversion process.
                                                      fail or refuse to comply with any                                                                              incentives available to EPA. One
                                                                                                              One SER observed that many users do                    potential incentive would be a delayed
                                                      provision of a rule promulgated under                   not know exactly how clean their
                                                      TSCA section 6. Therefore, any failure                                                                         implementation date for a ban on TCE
                                                                                                              products must be, or how clean their                   use in vapor degreasing. This incentive
                                                      to comply with this proposed rule when                  existing system gets them. According to
                                                      it becomes effective would be a                                                                                would allow vapor degreasing facilities
                                                                                                              this SER, testing is needed to determine               that intend to convert to aqueous
                                                      violation of TSCA section 15. In                        the required cleaning efficiency, and it
                                                      addition, TSCA section 15 makes it                                                                             cleaning systems a longer period of time
                                                                                                              can take six months for the testing.                   to make the conversion. One way to
                                                      unlawful for any person to: (1) Fail or                 Changing to a new system could take an
                                                      refuse to establish and maintain records                                                                       administer this incentive would be to
                                                                                                              additional twelve to eighteen months.                  require vapor degreasing facilities to
                                                      as required by this rule; (2) fail or refuse            Another SER agreed with the estimate of
                                                      to permit access to or copying of                                                                              specifically request an extension for a
                                                                                                              two years for a changeover, while still
                                                      records, as required by TSCA; or (3) fail                                                                      certain length of time. Of course, in
                                                                                                              another SER thought it could take
                                                      or refuse to permit entry or inspection                                                                        order to limit misuse of this extension
                                                                                                              anywhere from six months to four years.
                                                      as required by TSCA section 11.                                                                                opportunity, EPA would have to also
                                                                                                              In light of this input, EPA believes that
                                                         Violators may be subject to both civil                                                                      require documentation of the facility’s
                                                                                                              it is reasonable to establish the
                                                      and criminal liability. Under the penalty                                                                      clear intention to convert to an aqueous
                                                                                                              compliance date for the prohibition on
                                                      provision of TSCA section 16, any                                                                              cleaning system. This might include a
                                                                                                              TCE in vapor degreasing at two years
                                                      person who violates TSCA section 15                                                                            description of the steps the company
                                                                                                              from the date the final rule is
                                                      could be subject to a civil penalty for                                                                        has already taken to implement a
                                                                                                              promulgated. EPA believes that, in most
                                                      each violation. Each day of operation in                cases, the transition can be made within               change to aqueous substitutes, or a
                                                      violation of this proposed rule when it                 this time, but EPA requests comment on                 description of the specific plan for
                                                      becomes effective could constitute a                    whether there are special situations                   implementing the change within the
                                                      separate violation. Knowing or willful                  which may require more time.                           extension period requested, with some
                                                      violations of this proposed rule when it                   EPA would like to encourage as many                 sort of documentation, such as a
                                                      becomes effective could lead to the                     companies as possible to adopt less                    contract to purchase equipment. EPA
                                                      imposition of criminal penalties and                    hazardous technologies, such as                        also notes that TSCA section 6(d)
                                                      imprisonment. In addition, other                        aqueous cleaning systems, instead of                   generally provides that compliance
                                                      remedies are available to EPA under                     switching to an alternative that also                  dates for the start of a ban or phase-out
                                                      TSCA sections 7 and 17.                                 presents health risks for workers, albeit              promulgated under section 6(a) must be
                                                         Individuals, as well as corporations,                of a lower magnitude than TCE. EPA’s                   as soon as practicable, but not later than
                                                      could be subject to enforcement actions.                analysis indicates that the best answer                five years after the rule is promulgated,
                                                      TSCA sections 15 and 16 apply to ‘‘any                  for many vapor degreasing operations                   except for those critical or essential uses
                                                      person’’ who violates various provisions                may be a switch to water-based cleaners,               exempted under TSCA section 6(g). EPA
                                                      of TSCA. EPA may, at its discretion,                    even though there are higher upfront                   requests comments on all aspects of this
                                                      proceed against individuals as well as                  costs. An effective system that works for              potential incentive, including comments
                                                      companies. In particular, EPA may                       a given application and that is                        on the length of time that should be
                                                      proceed against individuals who report                  acceptable to customers must be                        allowed for an extension, what
                                                      false information or cause it to be                     researched and designed, new                           documentation should be required, and
                                                      reported.                                               equipment and cleaning solutions must                  which technologies or solvents should
                                                                                                              be purchased, new permits may be                       be eligible for an extension and how to
                                                      D. Implementation Dates and Incentives                                                                         define them. EPA also requests
                                                                                                              required, operating and safety
                                                        As proposed in the prior action on                    procedures must be updated, and                        comments on other potential incentives
                                                      TCE use (Ref. 1), the downstream                        affected employees must learn to                       or regulatory flexibilities that EPA could
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                                                      notification requirements and the                       operate the new equipment. However,                    incorporate to encourage the adoption of
                                                      recordkeeping requirements applicable                   once the system is up and running                      safer degreasing technologies. Finally,
                                                      to manufacturers (including importers)                  properly, operation of the system on an                in keeping with the SBAR Panel
                                                      and processors of TCE for any use and                   annual basis is likely to be less                      recommendation regarding flexibility
                                                      persons who distribute TCE in                           expensive and much less hazardous to                   for small businesses, EPA requests
                                                      commerce for any use (other than                        employees than a vapor degreasing                      comment on whether there are
                                                      retailers) would take effect 45 days after              system using TCE.                                      flexibilities other than delayed
                                                      the final rule is issued. EPA is                           EPA requests comment on its analysis                implementation dates that would be
                                                      proposing to make the ban on                            of the alternatives and the impacts of                 particularly advantageous for small


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                                7457

                                                      businesses while still ensuring that they                    10, 2014). http://www.regulations.gov/            26. EPA. TSCA Work Plan Chemicals:
                                                      address the unreasonable risks to which                      #!documentDetail;D=OSHA-2012-0023-                     Methods Document. Environmental
                                                      their workers may be exposed.                                0001.                                                  Protection Agency Office of Pollution
                                                                                                              13. National Institute for Occupational Safety              Prevention and Toxics. Washington, DC,
                                                      XI. References                                               and Health (NIOSH). Pocket Guide to                    February 2012. http://www.epa.gov/sites/
                                                                                                                   Chemical Hazards. U.S. Department of                   production/files/2014-03/documents/
                                                         The following is a listing of the                         Health and Human Services, Public                      work_plan_methods_document_web_
                                                      documents that are specifically                              Health Service, Centers for Disease                    final.pdf. Retrieved February 25, 2016.
                                                      referenced in this document. The docket                      Control and Prevention. Cincinnati, OH.           27. EPA. TSCA Work Plan Chemicals. Office
                                                      includes these documents and other                           1997.                                                  of Chemical Safety and Pollution
                                                      information considered by EPA,                          14. American Conference of Governmental                     Prevention. June 2012. http://
                                                      including documents referenced within                        Industrial Hygienists (ACGIH),                         www.epa.gov/sites/production/files/
                                                      the documents that are included in the                       Threshold Limit Values & Biological                    2014-02/documents/work_plan_
                                                                                                                   Exposure Indices for 2003, ACGIH,                      chemicals_web_final.pdf. Retrieved
                                                      docket, even if the referenced document                      Cincinnati, OH, 2003.                                  February 25, 2016.
                                                      is not physically located in the docket.                15. Cal. Code Regs. Title 17, § 94509 (2013).          28. EPA. A Review of the Reference Dose and
                                                      For assistance in locating these other                  16. Toxics Use Reduction Institute (TURI).                  Reference Concentration Processes. EPA/
                                                      documents, please consult the technical                      2013. http://www.turi.org/TURI_                        630/P-02/002F. December 2002.
                                                      person listed under FOR FURTHER                              Publications/TURI_Chemical_Fact_                  29. Johnson, P. D., S. J. Goldberg, M. Z. Mays,
                                                      INFORMATION CONTACT.                                         Sheets/Trichloroethylene_TCE_                          and B. V. Dawson. 2003. Threshold of
                                                                                                                   Fact_Sheet.                                            Trichloroethylene Contamination in
                                                      1. EPA. Trichloroethylene; Regulation of                17. Minnesota Department of Health.                         Maternal Drinking Waters Affecting Fetal
                                                           Certain Uses under TSCA § 6(a).                         Chemicals of High Concern List. July 1,                Heart Development in the Rat.
                                                           Proposed Rule. Federal Register. (81 FR                 2013. http://www.health.state.mn.us/                   Environmental Health Perspectives,
                                                           91592, December 16, 2016) (FRL–9949–                    divs/eh/hazardous/topics/toxfreekids/
                                                           86).                                                                                                           111(3), 289–292.
                                                                                                                   chclist/mdhchc2013.pdf.                           30. EPA. Supplemental Occupational
                                                      2. EPA. 2014. TSCA Work Plan Chemical                   18. LawAtlas: The Policy Surveillance Portal.
                                                           Risk Assessment. Trichloroethylene:                                                                            Exposure and Risk Reduction Technical
                                                                                                                   http://lawatlas.org/. Retrieved April 4,               Report in Support of Risk Management
                                                           Degreasing, Spot Cleaning and Arts &                    2016.
                                                           Crafts Uses. CASRN: 79–01–6. EPA/740/                                                                          Options for Trichloroethylene (TCE) Use
                                                                                                              19. European Chemicals Agency. Substance                    in Vapor Degreasing. Office of Chemical
                                                           R1/4002. Office of Chemical Safety and                  Information: Trichloroethylene. http://
                                                           Pollution Prevention, Washington, DC.                                                                          Safety and Pollution Prevention.
                                                                                                                   echa.europa.eu/da/substance-                           Washington, DC 2016.
                                                           https://www.epa.gov/assessing-and-                      information/-/substanceinfo/
                                                           managing-chemicals-under-tsca/tsca-                                                                       31. EPA. Expert Public Workshop on
                                                                                                                   100.001.062. Retrieved February 25,
                                                           work-plan-chemical-risk-assessment-0.                                                                          Alternatives and Risk Reduction
                                                                                                                   2016.
                                                      3. EPA (US Environmental Protection                                                                                 Approaches to Trichloroethylene. July
                                                                                                              20. European Chemicals Association.
                                                           Agency). 2016. Economic Assessment for                                                                         29–30, 2014. EPA Docket Number EPA–
                                                                                                                   Opinion on an Application for
                                                           Trichloroethylene (TCE) under TSCA                                                                             HQ–OPPT–2014–0327–0001.
                                                                                                                   Authorisation for Trichloroethylene:
                                                           Section 6. Office of Chemical Safety and                                                                  32. EPA. Final Report of the Small Business
                                                                                                                   Industrial use of trichloroethylene (TCE)
                                                           Pollution Prevention, Washington, DC.                   as a solvent as a degreasing agent in                  Advocacy Review Panel on EPA’s
                                                      4. EPA. Toxicological Review of                              closed systems (15 July 2015).                         Planned Proposed Rule Under Section
                                                           Trichloroethylene (CAS No. 79–01–6).               21. European Chemicals Association.                         6(a) of the Toxic Substances Control Act
                                                           EPA/–635/R-09/011F. Integrated Risk                     Opinion on an Application for                          (TSCA) as amended by the Frank R.
                                                           Information System, Washington, DC.                     Authorisation for Trichloroethylene: Use               Lautenberg Chemical Safety for the 21st
                                                           2011.                                                   of Trichloroethylene in Industrial Parts               Century Act for Use of Trichloroethylene
                                                      5. EPA. Guidelines for Developmental                         Cleaning by Vapour Degreasing in Closed                (TCE) in Vapor Degreasing. Office of
                                                           Toxicity Risk Assessment. EPA/600/FR–                   Systems where specific requirements                    Chemical Safety and Pollution
                                                           91/001. December 1991.                                  (system of use-parameters) exist (11                   Prevention. Washington, DC August,
                                                      6. EPA. Policy on Evaluating Health Risks to                 September 2015).                                       2016.
                                                           Children. October 20, 1995.                        22. Environment Canada. Priority Substances            33. EPA. The Effectiveness of Labeling on
                                                      7. International Agency for Research on                      List Assessment Report-                                Hazardous Chemicals and Other
                                                           Cancer. Monographs on the Evaluation of                 Trichloroethylene. Canada                              Products. Office of Chemical Safety and
                                                           Carcinogenic Risks to Humans:                           Environmental Protection Act. 1993.                    Pollution Prevention. Washington, DC
                                                           Cadmium, Trichloroethylene,                             http://www.hc-sc.gc.ca/ewh-semt/pubs/                  2016.
                                                           Tetrachloroethylene, and Some                           contaminants/psl1-lsp1/                           34. Unintended pregnancy in the United
                                                           Chlorinated Agents. Volume 106. World                   trichloroethylene/index-eng.php.                       States: Incidence and disparities, 2006.
                                                           Health Organization, Lyon, France.                      Retrieved March 7, 2016.                               Contraception. 2011;84(5):478–485.
                                                      8. National Toxicology Program. 12th Report             23. Environment Canada. Solvent Degreasing             35. EPA. Summary of External Peer Review
                                                           on Carcinogens. 2011. Available at                      Regulations (SOR/2003–283) http://                     and Public Comments and Disposition.
                                                           http://ntp.niehs.nih.gov/go/37899.                      www.ec.gc.ca/lcpe-cepa/eng/regulations/           36. EPA. Recommendations for an Existing
                                                      9. EPA. Protection of Stratospheric Ozone:                   detailreg.cfm?intReg=76. Retrieved                     Chemical Exposure Limit (ECEL) for
                                                           Listing of Ozone-Depleting Substances—                  March 7, 2016.                                         Occupational Use of Trichloroethylene
                                                           n-Propyl Bromide in Solvent Cleaning.              24. Incorporated Administrative Agency                      (TCE) and Sampling and Analytical
                                                           Final Rule. Federal Register (72 FR                     National Institute of Technology and                   Methods for TCE. Office of Chemical
                                                           30142, May 30, 2007) (FRL–8316–8).                      Evaluation. Chemical Risk Information                  Safety and Pollution Prevention.
                                                      10. EPA. Trichloroethylene; Significant New                  Platform (CHRIP). http://                              Washington, DC August 28, 2015.
                                                           Use Rule. Final Rule. Federal Register                  www.safe.nite.go.jp/english/sougou/               37. OSHA. Respiratory Protection. Final rule;
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                           (81 FR 20535, April 8, 2016) (FRL–9943–                 view/ComprehensiveInfo                                 request for comment on paperwork
                                                           83).                                                    Display_en.faces. Retrieved March 7,                   requirements. Federal Register (63 FR
                                                      11. Occupational Safety and Health                           2016.                                                  1152 January 9, 1998).
                                                           Administration (OSHA). Occupational                25. Australian Government Department of                38. OSHA. Respiratory Protection Standard.
                                                           Safety and Health Standards, Toxic and                  Health National Industrial Chemicals                   29 CFR 1910.134.
                                                           Hazardous Substances. Code of Federal                   Notification and Assessment Scheme.               39. EPA. Section 5(e) Consent Order New
                                                           Regulations 29 CFR 1910.1000. 1998.                     AICS Listing. http://www.nicnas.gov.au/                Chemicals Exposure Limits (NCEL)
                                                      12. OSHA. Chemical Management and                            regulation-and-compliance/aics/aics-                   Insert.
                                                           Permissible Exposure Limits (PELs).                     search-page/chemical?id=1092.                     40. CDC. Facts about Congenital Heart
                                                           Federal Register 79 FR 61384 (October                   Retrieved March 7, 2016.                               Defects http://www.cdc.gov/ncbddd/



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                                                      7458                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                           heartdefects/facts.html. December 22,                   primary care setting. Int J Clin Pract.           67. EPA. Section 6(a) Rulemakings under the
                                                           2015. Accessed March 1, 2016.                           2010;64(6):682–696.                                    Toxic Substances Control Act (TSCA)
                                                      41. The National Academies Press,                       54. International Association for the Study of              Paint Removers & TCE Rulemakings E.O.
                                                           Committee on Developmental                              Pain. http://www.iasp-pain.org/files/                  13132: Federalism Consultation. May 13,
                                                           Toxicology, Board on Environmental                      Content/ContentFolders/GlobalYear                      2015.
                                                           Studies and Toxicology, Commission on                   AgainstPain2/20132014OrofacialPain/               68. EPA. Notification of Consultation and
                                                           Life Sciences, National Research                        FactSheets/Trigeminal_Neuralgia.pdf.                   Coordination on Proposed Rulemakings
                                                           Council. Scientific Frontiers in                        2013.                                                  under the Toxic Substances Control Act
                                                           Developmental Toxicology and Risk                  55. American Liver Foundation. Non-                         for (1) Methylene Chloride and n-
                                                           Assessment. Washington, DC. http://                     Alcoholic Fatty Liver Disease (NAFLD).                 Methylpyrrolidone in Paint Removers
                                                           www.nap.edu/read/9871/chapter/4.                        http://www.liverfoundation.org/                        and (2) Trichloroethylene in Certain
                                                           2000.                                                   abouttheliver/info/nafld/. January 14,                 Uses. April 8, 2015.
                                                      42. Mayo clinic. Chronic kidney disease.                     2015. Retrieved April 4, 2016.
                                                           http://www.mayoclinic.org/diseases-                56. CDC. Viral Hepatitis—Statistics and                XII. Statutory and Executive Order
                                                           conditions/kidney-disease/basics/                       Surveillance. http://www.cdc.gov/                 Reviews
                                                           definition/con-20026778. January 30,                    hepatitis/Statistics/index.htm. May 31,             Additional information about these
                                                           2015.                                                   2014. Retrieved April 4, 2016.
                                                      43. American Kidney Fund. 2015 Kidney                   57. United Network for Organ Sharing                   statutes and Executive Orders can be
                                                           Disease Statistics. http://                             (UNOS) Transplant Living. Financing a             found at http://www2.epa.gov/laws-
                                                           www.kidneyfund.org/about-us/assets/                     Transplant—Costs. December 28, 2011.              regulations/laws-and-executive-orders.
                                                           pdfs/kidney_disease_statistics_2015.pdf.                Available athttp://transplantliving.org/
                                                                                                                                                                     A. Executive Order 12866: Regulatory
                                                      44. The Kidney Boy. The Cost of Dialysis.                    before-the-transplant/financing-a-
                                                           http://thekidneyboy.blogspot.com/2011/                  transplant/the-costs/. Retrieved March            Planning and Review and Executive
                                                           01/cost-of-dialysis.html. January 20,                   16, 2016.                                         Order 13563: Improving Regulation and
                                                           2011.                                              58. EPA. Analysis Report of Alternatives in            Regulatory Review
                                                      45. Silman AJ, Hochberg MC, Cooper C, et al.                 Support of Risk Management Options for              This action is an economically
                                                           Epidemiology of the Rheumatic Diseases.                 Use of TCE in Vapor Degreasing, Office            significant regulatory action that was
                                                           Oxford, U.K.: Oxford University Press;                  of Chemical Safety and Pollution
                                                                                                                   Prevention. Washington, DC. 2016.
                                                                                                                                                                     submitted to the Office of Management
                                                           1993:192. Cited in Hinchcliff, M.; Varga,
                                                           Systemic sclerosis/scleroderma: A                  59. EPA. Petition to Add n-Propyl Bromide              and Budget (OMB) for review under
                                                           treatable multisystem disease. J. Am Fam                to the List of Hazardous Air Pollutants.          Executive Orders 12866 (58 FR 51735,
                                                           Physician. 78(8):961–8. 2008.                           Receipt of a complete petition. (80 FR            October 4, 1993) and 13563 (76 FR 3821,
                                                      46. Lawrence RC, Helmick CG, Arnett FC, et                   6676, February 6, 2015) (FRL–9922–13).            January 21, 2011). Any changes made in
                                                           al. Estimates of the prevalence of                 60. EPA. 2014. TSCA Work Plan Chemical                 response to OMB recommendations
                                                           arthritis and selected musculoskeletal                  Risk Assessment. Methylene Chloride,              have been documented in the docket.
                                                           disorders in the United States. Arthritis               Paint Stripping Use. CASRN: 75–09–2.              EPA prepared an economic analysis of
                                                           Rheum. 1998;41(5):778–799. Cited in                     EPA/740/R1/4002. Office of Chemical               the potential costs and benefits
                                                           Hinchcliff, M.; Varga, Systemic sclerosis/              Safety and Pollution Prevention,
                                                                                                                   Washington, DC. https://www.epa.gov/
                                                                                                                                                                     associated with this action, which is
                                                           scleroderma: A treatable multisystem
                                                           disease. J. Am Fam Physician. 2008 Oct                  assessing-and-managing-chemicals-                 available in the docket and summarized
                                                           15;78(8):961–8.                                         under-tsca/tsca-work-plan-chemical-               in Unit VII. (Ref. 3).
                                                      47. National Cancer Institute. SEER Stat Fact                risk-assessment-methylene.                        B. Paperwork Reduction Act (PRA)
                                                           Sheets: Non-Hodgkin Lymphoma.                      61. EPA. 2016. TSCA Work Plan Chemical
                                                           Bethesda, MD. http://seer.cancer.gov/                   Risk Assessment PEER REVIEW DRAFT.                   The information collection
                                                           statfacts/html/nhl.html. Retrieved March                1-Bromopropane: (n-Propyl Bromide).               requirements in this proposed rule have
                                                           16, 2016. Mayo Clinic.                                  Spray Adhesives, Dry Cleaning, and                been submitted to OMB for review and
                                                      48. Non-Hodgkin’s lymphoma Risk Factors.                     Degreasing Uses. CASRN: 106–94–5.                 comment under the PRA, 44 U.S.C. 3501
                                                           January 28, 2016. http://                               EPA/740/R1/5001. Office of Chemical               et seq. The Information Collection
                                                           www.mayoclinic.org/diseases-                            Safety and Pollution Prevention,                  Request (ICR) document prepared by the
                                                           conditions/non-hodgkins-lymphoma/                       Washington, DC. https://www.epa.gov/
                                                           basics/risk-factors/con-20027792.                       sites/production/files/2016-03/
                                                                                                                                                                     Agency has been assigned EPA ICR No.
                                                           Retrieved March 7, 2016.                                documents/1-bp_report_and_                        2541.02. You can find a copy of the ICR
                                                      49. Morton LM, Curtis RE, Linet MS, et al.                   appendices_final.pdf.                             in the docket for this proposed rule (Ref.
                                                           Second Malignancy Risks After Non-                 62. EPA. 2012. Toxicological Review of                 65), and it is briefly summarized here.
                                                           Hodgkin’s Lymphoma and Chronic                          Tetrachloroethylene (Perchloroethylene)              The information collection activities
                                                           Lymphocytic Leukemia: Differences by                    (CAS No. 127–18–4) in Support of                  required under the proposed rule
                                                           Lymphoma Subtype. Journal of Clinical                   Summary Information on the Integrated             include a downstream notification
                                                           Oncology. 2010;28(33):4935–4944.                        Risk Information System (IRIS) (February          requirement and a recordkeeping
                                                           doi:10.1200/JCO.2010.29.1112.                           2012).                                            requirement. The downstream
                                                      50. Sharma R, Biedenharn KR, Fedor JM,                  63. EPA. Evaluation of Water-Based Cleaners.
                                                                                                                                                                     notification would require companies
                                                           Agarwal A. Lifestyle factors and                        Office of Chemical Safety and Pollution
                                                           reproductive health: Taking control of                  Prevention. Washington, DC. 2016.                 that ship TCE to notify companies
                                                           your fertility. Reproductive Biology and           64. Institute for Research and Technical               downstream in the supply chain of the
                                                           Endocrinology: RB&E. 2013;11:66.                        Assistance. Memo from Katy Wolf to                prohibitions of TCE in the proposed
                                                           doi:10.1186/1477–7827–11–66.                            Emily Connor at ABT Associates. May               rule. The proposed rule does not require
                                                      51. CDC. National Center for Health                          15, 2015.                                         the regulated entities to submit
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                                                           Statistics—Infertility. February 6, 2015.          65. EPA. Information Collection Request                information to EPA. The proposed rule
                                                           http://www.cdc.gov/nchs/fastats/                        (ICR) for the Regulation of Use in Vapor          also does not require confidential or
                                                           infertility.htm. Retrieved March 16, 2016.              Degreasing under TSCA § 6(a) (Proposed            sensitive information to be submitted to
                                                      52. Gruenewald DA, Matsumoto AM.                             Rule). EPA ICR No. 2541.02 and OMB                EPA or downstream companies. The
                                                           Testosterone supplementation therapy                    No. 2070–[NEW].
                                                           for older men: Potential benefits and              66. EPA. Initial Regulatory Flexibility
                                                                                                                                                                     recordkeeping requirement mandates
                                                           risks. J Am Geriatr Soc. 2003;51(1):101–                Analysis for Trichloroethylene (TCE);             companies that ship TCE to retain
                                                           115.                                                    Regulation of Use in Vapor Degreasing             certain information at the company
                                                      53. Dadona P, Rosenberg MT. A practical                      under TSCA § 6(a); Proposed Rule.                 headquarters for three years from the
                                                           guide to male hypogonadism in the                       January 2017.                                     date of shipment. These information


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                            7459

                                                      collection activities are necessary in                  potentially exposed or susceptible                     TCE may involve special skills, such as
                                                      order to enhance the prohibitions under                 subpopulation identified as relevant to                engineering experience.
                                                      the proposed rule by ensuring                           the risk evaluation, under the                            5. Other Federal regulations. Other
                                                      awareness of the prohibitions                           conditions of use, EPA must by rule                    Federal regulations that affect the use of
                                                      throughout the TCE supply chain, and                    apply one or more requirements to the                  TCE in vapor degreasing are discussed
                                                      to provide EPA with information upon                    extent necessary so that the chemical                  in Unit III.A. of this preamble. Because
                                                      inspection of companies downstream                      substance or mixture no longer presents                the NESHAP regulates only emissions
                                                      who purchased TCE. EPA believes that                    such risk. Based on EPA’s risk                         from vapor degreasing facilities, not
                                                      these information collection activities                 assessment of TCE (Ref. 2), EPA’s                      worker exposures, and because the 1971
                                                      would not significantly impact the                      proposed determination is that the use                 OSHA PEL is not sufficiently protective,
                                                      regulated entities.                                     of TCE in vapor degreasing presents an                 EPA’s proposal is not duplicative of
                                                        Respondents/Affected Entities: TCE                    unreasonable risk of injury to health and              other Federal rules nor does it conflict
                                                      manufacturers, processors, and                          that the provisions of this proposal are               with other Federal rules.
                                                      distributors.                                           necessary to address the unreasonable                     6. Regulatory alternatives considered.
                                                        Respondent’s Obligation to Respond:                   risk.                                                  EPA considered a wide variety of
                                                      Mandatory.                                                 2. Objectives and legal basis. The                  control measures and the Economic
                                                        Estimated Number of Respondents:                      legal basis for this proposal is TSCA                  Analysis (Ref. 3) examined several
                                                      697.                                                    section 6(a), which provides authority                 alternative analytical options. However,
                                                        Frequency of Response: On occasion.                   for the Administrator to apply                         EPA determined that most of the
                                                        Total Estimated Burden: 348.5 hours                   requirements to the extent necessary so                alternatives did not effectively address
                                                      (per year). Burden is defined at 5 CFR                  that a chemical substance or mixture no                the unreasonable risk presented by TCE
                                                      1320.3(b).                                              longer presents an unreasonable risk of                in vapor degreasing. The primary
                                                        Total Estimated Cost: $16,848 (per
                                                                                                              injury to health or the environment.                   alternative considered by EPA was to
                                                      year).
                                                        An agency may not conduct or                          Additionally, for a chemical substance,                allow the use of TCE in closed-loop
                                                      sponsor, and a person is not required to                such as TCE, which is listed in the 2014               vapor degreasing systems and require
                                                      respond to a collection of information                  update to the TSCA Work Plan for                       respiratory protection equipment for
                                                      unless it displays a currently valid OMB                Chemical Assessments for which a                       workers operating the equipment in the
                                                      control number. The OMB control                         completed risk assessment was                          form of a full face piece self-contained
                                                      numbers for EPA’s regulations in 40                     published prior to the date of enactment               breathing apparatus (SCBA) in pressure
                                                      CFR are listed in 40 CFR part 9.                        of the Frank R. Lautenberg Chemical                    demand mode or other positive pressure
                                                        Submit your comments on the                           Safety for the 21st Century Act, TSCA                  mode with an APF of 10,000 with an
                                                      Agency’s need for this information, the                 section 26(l)(4) expressly authorizes                  alternative to the specified APF
                                                      accuracy of the provided burden                         EPA to issue rules under TSCA section                  respirator of an air exposure limit.
                                                      estimates, and any suggested methods                    6(a) that are consistent with the scope                Depending on air concentrations and
                                                      for minimizing respondent burden to                     of the completed risk assessment and                   proximity to the vapor degreasing
                                                      EPA using the docket identified at the                  consistent with the other applicable                   equipment, other employees in the area
                                                      beginning of this proposed rule. You                    requirements of TSCA section 6.                        would also need to wear respiratory
                                                      may also send your ICR-related                             3. Small entities covered by this                   protection equipment. While this option
                                                      comments to OMB’s Office of                             proposal. EPA estimates that the                       would address the unreasonable risks
                                                      Information and Regulatory Affairs via                  proposal would affect approximately                    presented by TCE in vapor degreasing,
                                                      email to oira_submission@omb.eop.gov.                   2,500 to 6,000 small entities. The                     EPA’s Economic Analysis indicates that
                                                      Attention: Desk Officer for EPA. Since                  majority of these entities are commercial              this option is more expensive and, thus
                                                      OMB is required to make a decision                      users of TCE in vapor degreasing                       less cost effective than switching to a
                                                      concerning the ICR between 30 and 60                    machines in a variety of occupational                  different solvent or cleaning system.
                                                      days after receipt, OMB must receive                    settings such as metal plating,                           As required by section 609(b) of the
                                                      comments no later than February 21,                     electronics assembly, metal or                         RFA, EPA also convened a Small
                                                      2017. EPA will respond to any ICR-                      composite part fabrication, and repair                 Business Advocacy Review (SBAR)
                                                      related comments in the final rule.                     shops.                                                 Panel to obtain advice and
                                                                                                                 4. Compliance requirements and the                  recommendations from small entity
                                                      C. Regulatory Flexibility Act (RFA)                     professional skills needed. To address                 representatives that potentially would
                                                         Pursuant to section 603 of the RFA, 5                the unreasonable risks that EPA has                    be subject to the rule’s requirements.
                                                      U.S.C. 601 et seq., EPA prepared an                     identified, this proposal would prohibit               The SBAR Panel evaluated the
                                                      initial regulatory flexibility analysis                 the manufacture (including import),                    assembled materials and small-entity
                                                      (IRFA) that examines the impact of the                  processing, and distribution in                        comments on issues related to elements
                                                      proposed rule on small entities along                   commerce of TCE for use in vapor                       of an IRFA. A copy of the full SBAR
                                                      with regulatory alternatives that could                 degreasing; prohibit commercial use of                 Panel Report is available in the
                                                      minimize that impact. The complete                      TCE in vapor degreasing; and require                   rulemaking docket. The Panel
                                                      IRFA is available for review in the                     manufacturers, processors, and                         recommended that EPA seek additional
                                                      docket and is summarized here (Ref.                     distributors, except for retailers, to                 information on critical uses; availability,
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                                                      66).                                                    provide downstream notification of this                effectiveness, and costs of alternatives;
                                                         1. Need for the rule. Under TSCA                     prohibition throughout the supply chain                implementation timelines; and exposure
                                                      section 6(a) (15 U.S.C. 2605(a)), if EPA                (e.g., via a Safety Data Sheet (SDS)), and             information to provide flexibility to
                                                      determines after risk evaluation that a                 to keep records. Complying with the                    lessen impacts to small entities, as
                                                      chemical substance presents an                          prohibitions, the downstream                           appropriate. Throughout this preamble,
                                                      unreasonable risk of injury to health or                notification, and the recordkeeping                    EPA has requested information with
                                                      the environment, without consideration                  requirements involve no special skills.                respect to these and other topics. The
                                                      of costs or other non-risk factors,                     However, design and implementation of                  Panel made the following specific
                                                      including an unreasonable risk to a                     an alternative to vapor degreasing with                recommendations:


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                                                      7460                   Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules

                                                         a. Critical uses. The Panel                          alternative to TCE (i.e., the cost of going            docket (Ref. 67). Although EPA
                                                      recommended that EPA provide                            out of business). The Panel                            provided these organizations an
                                                      exemption, in accordance with TSCA                      recommended that EPA request                           opportunity to provide follow-up
                                                      section 6(g), for those critical uses for               additional information on the cost to                  comments in writing, no written follow-
                                                      which EPA can obtain adequate                           achieve reduced exposures in the                       up was received by the Agency.
                                                      documentation that:                                     workplace or to transition to alternative
                                                         • No technically and economically                                                                           F. Executive Order 13175: Consultation
                                                                                                              chemicals or technologies.
                                                      feasible safer alternative is available;                   e. Exposure information. The Panel                  and Coordination With Indian Tribal
                                                         • Compliance with the ban would                      recommended that EPA include in its                    Governments
                                                      significantly disrupt the national                      proposal specific requests for additional                 This action does not have tribal
                                                      economy, national security, or critical                 pertinent exposure data that may be                    implications, as specified in Executive
                                                      infrastructure; or                                      available.                                             Order 13175 (65 FR 67249, November 9,
                                                         • The specific condition of use, as                     f. Risk assessment. The Panel                       2000). This rulemaking would not have
                                                      compared to reasonably available                        recommended that EPA recognize the                     substantial direct effects on tribal
                                                      alternatives, provides a substantial                    concerns that the SERs had on the risk                 government because TCE is not
                                                      benefit to health, the environment, or                  assessment by referring readers to the                 manufactured, processed, or distributed
                                                      public safety.                                          risk assessment and the Agency’s                       in commerce by tribes. TCE is not
                                                         To that end, the Panel recommended                   Summary of External Peer Review and                    regulated by tribes, and this rulemaking
                                                      that EPA include in its proposal specific               Public Comments and Disposition                        would not impose substantial direct
                                                      targeted requests for comment directed                  document, which addresses those                        compliance costs on tribal governments.
                                                      towards identifying critical uses (such                 concerns, in the preamble of the                       Thus, EO 13175 does not apply to this
                                                      as the aeronautics industry and national                proposed rulemaking.                                   action. EPA nevertheless consulted with
                                                      security) and obtaining information to                                                                         tribal officials during the development
                                                                                                              D. Unfunded Mandates Reform Act
                                                      justify exemptions. The Panel also                                                                             of this action, consistent with the EPA
                                                                                                              (UMRA)
                                                      recommended that EPA request public                                                                            Policy on Consultation and
                                                      comment on allowing the use of TCE in                     This action does not contain an                      Coordination with Indian Tribes.
                                                      closed-top vapor degreasing systems                     unfunded mandate of $100 million or                       EPA met with tribal officials in a
                                                      with the use of appropriate PPE.                        more as described in UMRA, 2 U.S.C.                    national informational webinar held on
                                                         b. Alternatives. The Panel                           1531–1538, and does not significantly or               May 12, 2015 concerning the
                                                      recommended that EPA ensure that its                    uniquely affect small governments. The                 prospective regulation of TCE under
                                                      analysis of the available alternatives to               requirements of this action would                      TSCA section 6, and in another
                                                      TCE in vapor degreasing complies with                   primarily affect persons who                           teleconference with tribal officials on
                                                      the requirements of section 6(c)(2)(C)                  commercially use TCE in vapor                          May 27, 2015 (Ref. 68). EPA also met
                                                      and includes consideration, to the                      degreasing equipment. The total                        with the National Tribal Toxics Council
                                                      extent legally permissible and                          estimated annualized cost of the                       (NTTC) in Washington, DC and via
                                                      practicable, of whether technically and                 proposed rule is approximately $30                     teleconference on April 22, 2015 (Ref.
                                                      economically feasible alternatives that                 million to $45 million at 3% and $32                   68). In those meetings, EPA provided
                                                      benefit health or the environment,                      million to $46 million at 7% (Ref. 3).                 background information on the
                                                      compared to the use being prohibited or                 E. Executive Order 13132: Federalism                   proposed rule and a summary of issues
                                                      restricted, will be reasonably available                                                                       being explored by the Agency. These
                                                      as a substitute when the proposed                         EPA has concluded that this action                   officials expressed concern for TCE
                                                      requirements would take effect.                         has federalism implications, as specified              contamination on tribal lands and
                                                      Specifically, the Panel recommended                     in Executive Order 13132 (64 FR 43255,                 supported additional regulation of TCE.
                                                      that EPA:                                               August 10, 1999), because regulation
                                                                                                              under TSCA section 6(a) may preempt                    G. Executive Order 13045: Protection of
                                                         • Evaluate the feasibility of using
                                                                                                              state law. EPA provides the following                  Children From Environmental Health
                                                      alternatives, including the cost, relative
                                                                                                              preliminary federalism summary impact                  Risks and Safety Risks
                                                      safety, and other barriers (such as space
                                                      constraints, cleaning efficiency,                       statement. The Agency consulted with                      This action is subject to Executive
                                                      increased energy use, cycle time, boiling               state and local officials early in the                 Order 13045 (62 FR 19885, April 23,
                                                      points, and water use restrictions); and                process of developing the proposed                     1997), because it is an economically
                                                         • Take into consideration the current                action to permit them to have                          significant regulatory action as defined
                                                      and future planned regulation of                        meaningful and timely input into its                   by Executive Order 12866, and EPA
                                                      compounds the Agency has listed as                      development. EPA invited the following                 believes that the environmental health
                                                      alternatives.                                           national organizations representing state              or safety risk addressed by this action
                                                         c. Implementation timelines. The                     and local elected officials to a meeting               has a disproportionate effect on
                                                      Panel recommended that EPA provide                      on May 13, 2015, in Washington DC:                     children, specifically on the developing
                                                      regulatory flexibility, as applicable,                  National Governors Association;                        fetus. Accordingly, we have evaluated
                                                      based on additional information, such                   National Conference of State                           the environmental health or safety
                                                      as delayed compliance or a phase-out                    Legislatures, Council of State                         effects of TCE used in vapor degreasing
                                                      option, for small businesses that may be                Governments, National League of Cities,                on children. The results of this
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                                                      affected by the rule and in its proposal                U.S. Conference of Mayors, National                    evaluation are discussed in Units I.F.,
                                                      specifically request additional                         Association of Counties, International                 II.C., IV., and VI.C. of this preamble and
                                                      information regarding timelines for                     City/County Management Association,                    in the economic analysis (Ref. 3).
                                                      transitioning to alternative chemicals or               National Association of Towns and                         Supporting information on the
                                                      technologies.                                           Townships, County Executives of                        exposures and health effects of TCE
                                                         d. Cost information. The Panel also                  America, and Environmental Council of                  exposure on children is also available in
                                                      recommended that EPA specifically                       States. A summary of the meeting with                  the Toxicological Review of
                                                      evaluate the cost to small business                     these organizations, including the views               Trichloroethylene (Ref. 4) and the TCE
                                                      degreasing services without a viable                    that they expressed, is available in the               risk assessment (Ref. 2).


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                                                                             Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules                                                 7461

                                                      H. Executive Order 13211: Actions                       as appropriate, disproportionately high                    Authority: 15 U.S.C. 2605.
                                                      Concerning Regulations That                             and adverse health or environmental
                                                      Significantly Affect Energy Supply,                     effects of their programs, policies and                ■  2. In § 751.303, add the definition
                                                      Distribution in Commerce, or Use                        activities on minority populations and                 ‘‘Vapor’’ in alphabetical order to read as
                                                                                                              low-income populations in the U.S.                     follows:
                                                         This proposed rule is not subject to                 Units IV. and VI. of this preamble
                                                      Executive Order 13211 (66 FR 28355,                                                                            § 751.303    Definitions.
                                                                                                              address public health impacts from
                                                      May 22, 2001), because this action is not               TCE. EPA has determined that there                     *      *     *    *     *
                                                      expected to affect energy supply,                       would not be a disproportionately high                   Vapor degreasing means a cleaning
                                                      distribution in commerce, or use. This                  and adverse health or environmental                    process involving heating a solvent to
                                                      rulemaking is intended to protect                       effects on minority, low income, or                    produce a hot vapor which is then used
                                                      against risks from TCE, and does not                    indigenous populations from this
                                                      affect the use of oil, coal, or electricity.                                                                   to remove contaminants such as grease,
                                                                                                              proposed rule.                                         oils, dust, and dirt from fabricated parts
                                                      I. National Technology Transfer and                     List of Subjects in 40 CFR Part 751                    and other materials.
                                                      Advancement Act (NTTAA)
                                                                                                                Environmental protection, Chemicals,                 ■ 3. Add § 751.309 to read as follows:
                                                        This proposed rulemaking does not                     Export certification, Hazardous
                                                                                                                                                                     § 751.309    Vapor degreasing.
                                                      involve technical standards, and is                     substances, Import certification,
                                                      therefore not subject to considerations                 Recordkeeping.                                           (a) After [date 18 months after the
                                                      under NTTAA section 12(d), 15 U.S.C.                      Dated: January 11, 2017.                             date of publication of the final rule], all
                                                      272 note.                                               Gina McCarthy,                                         persons are prohibited from
                                                      J. Executive Order 12898: Federal                       Administrator.                                         manufacturing (including import),
                                                      Actions To Address Environmental                          Therefore, 40 CFR part 751, as                       processing, and distributing in
                                                      Justice in Minority Populations and                     proposed to be added at 81 FR 91592                    commerce TCE and mixtures containing
                                                      Low-Income Populations                                  (December 16, 2016), is proposed to be                 TCE for use in vapor degreasing.
                                                                                                              further amended to read as follows:                      (b) After [date 2 years after the date
                                                        Executive Order 12898 (59 FR 7629,
                                                      February 16, 1994) establishes federal                                                                         of publication of the final rule], all
                                                                                                              PART 751—REGULATION OF CERTAIN                         persons are prohibited from commercial
                                                      executive policy on environmental                       CHEMICAL SUBSTANCES AND
                                                      justice. Its main provision directs                                                                            use of TCE and mixtures containing TCE
                                                                                                              MIXTURES UNDER SECTION 6 OF THE
                                                      federal agencies, to the greatest extent                                                                       in vapor degreasing.
                                                                                                              TOXIC SUBSTANCES CONTROL ACT
                                                      practicable and permitted by law, to                                                                           [FR Doc. 2017–01229 Filed 1–18–17; 8:45 am]
                                                      make environmental justice part of their                ■ 1. The authority citation for part 751               BILLING CODE 6560–50–P
                                                      mission by identifying and addressing,                  continues to read as follows:
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Document Created: 2018-02-01 15:15:18
Document Modified: 2018-02-01 15:15:18
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesComments must be received on or before March 20, 2017.
ContactFor technical information contact: Cindy Wheeler, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
FR Citation82 FR 7432 
RIN Number2070-AK11
CFR AssociatedEnvironmental Protection; Chemicals; Export Certification; Hazardous Substances; Import Certification and Recordkeeping

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