Trichloroethylene; Regulation of Certain Uses Under TSCA § 6(a), 91592-91624 [2016-30063]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 81, Number 242 (Friday, December 16, 2016)]
[Proposed Rules]
[Pages 91592-91624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30063]



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Vol. 81

Friday,

No. 242

December 16, 2016

Part VIII





Environmental Protection Agency





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40 CFR Part 751





Trichloroethylene; Regulation of Certain Uses Under TSCA Sec.  6(a); 
Proposed Rule

Federal Register / Vol. 81 , No. 242 / Friday, December 16, 2016 / 
Proposed Rules

[[Page 91592]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 751

[EPA-HQ-OPPT-2016-0163; FRL-9949-86]
RIN 2070-AK03


Trichloroethylene; Regulation of Certain Uses Under TSCA Sec.  
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 aerosol degreasing and for spot 
cleaning in dry cleaning facilities. EPA has preliminarily determined 
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, processing, and distribution in 
commerce of TCE for use in aerosol degreasing and for use in spot 
cleaning in dry cleaning facilities; to prohibit commercial use of TCE 
for aerosol degreasing and for spot cleaning in dry cleaning 
facilities; 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 February 14, 2017.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2016-0163, at https://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comments cannot be edited or withdrawn.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 https://www2.epa.gov/dockets/commenting-epa-dockets.
    Docket. Docket number EPA-HQ-OPPT-2016-0163 contains supporting 
information used in developing the proposed rule, comments on the 
proposed rule, and additional supporting information. A public version 
of 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: 
Toni Krasnic, Chemical Control Division, Office of Pollution Prevention 
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001; telephone number: (202) 564-0984; email 
address: krasnic.toni@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Does this action apply to me?

    You may potentially be 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 aerosol 
degreasers or for spot cleaning in dry cleaning facilities. 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:
     All Other Miscellaneous Textile Product Mills (NAICS code 
314999).
     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).

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     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 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 section 6(a) of TSCA (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, 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. Section 
6(b)(4) (15 U.S.C. 2605(b)(4)) specifies that risk evaluations must be 
conducted 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.
    Since the original enactment of TSCA in 1976, EPA has addressed 
exposure to workers. For example, EPA routinely places restrictions on 
conditions of manufacturing, processing, distribution and use under the 
TSCA section 5 (15 U.S.C. 2604) new chemicals program. Further, as 
defined in TSCA, the term ``potentially exposed or susceptible 
subpopulation'' specifically includes workers. (15 U.S.C. 2602(12)). 
Thus, TSCA unambiguously provides EPA with the authority to address 
chemical risks to workers.
    When issuing a rule under TSCA section 6(a), EPA must consider and 
publish a statement based on reasonably available information on the:
     Health effects of the chemical substance in question, TCE 
in this case, and the magnitude of human exposure to TCE;
     Environmental effects of TCE and the magnitude of exposure 
of the environment to TCE;
     Benefits of TCE for various uses; and the
     Reasonably ascertainable economic consequences of the 
rule, including: The likely effect of the rule on the national economy, 
small business, technological innovation, the environment, and public 
health; the costs 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.
    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.
    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 recognizes that EPA may 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 
aerosol degreasing and spot cleaning. The completed risk assessment 
also evaluated vapor degreasing, which EPA plans to address in a 
separate proposed rule.

C. What action is the Agency taking?

    EPA has preliminarily determined that the use of TCE in aerosol 
degreasing and for spot cleaning in dry cleaning facilities presents an 
unreasonable risk of injury to health. Accordingly, EPA is proposing 
under section 6 of TSCA to prohibit the manufacture, processing, and 
distribution in commerce of TCE for use in aerosol degreasing and for 
use in spot cleaning in dry cleaning facilities; to prohibit commercial 
use of TCE for aerosol degreasing and for spot cleaning in dry cleaning 
facilities; and to require manufacturers, processors, and distributors, 
except for retailers, to provide downstream notification of these 
prohibitions throughout the supply chain (e.g., via a Safety Data Sheet 
(SDS)) and to keep limited records. The application of this supply

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chain approach is necessary so that the chemical substance no longer 
presents the identified unreasonable risks. EPA is requesting public 
comment on this proposal.
    EPA's analysis of worker and consumer populations' exposures to TCE 
also preliminarily indicates that the use of TCE in vapor degreasing 
presents an unreasonable risk of injury to health. EPA intends to issue 
a separate proposed rule for TCE use in vapor degreasing, but plans to 
issue one final rule covering both today's proposal and the vapor 
degreasing proposal.

D. Why is the Agency taking this action?

    Based on EPA's analysis of worker and consumer populations' 
exposures to TCE, EPA has preliminarily determined that the use of TCE 
in aerosol degreasing and as a spot cleaner in dry cleaning facilities 
presents an unreasonable risk to human health. More specifically, these 
uses result in significant non-cancer risks (acute and chronic exposure 
scenarios) and cancer risks. These adverse health effects include 
developmental toxicity (e.g., cardiac malformations, developmental 
immunotoxicity, developmental neurotoxicity, fetal death), toxicity to 
the kidney (kidney damage and kidney cancer), immunotoxicity (such as 
systemic autoimmune diseases, e.g., scleroderma, and severe 
hypersensitivity skin disorder), non-Hodgkin's lymphoma, 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. 1). TCE may cause fetal 
cardiac malformations that begin in utero. In addition, fetal death, 
possibly resulting from cardiac malformation, can be caused by exposure 
to TCE. Cardiac malformations can be irreversible and impact a person's 
health for a lifetime. In utero exposure to TCE may cause other 
effects, such as damage to the developing immune system, which manifest 
later in adult 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. 
The application of this supply chain approach tailored to specific uses 
that present unreasonable risk 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 aerosol degreasing and for spot cleaning in dry cleaning 
facilities; prohibiting the commercial use of TCE for aerosol 
degreasing and for spot cleaning in dry cleaning facilities; 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, which is available in the docket, is 
discussed in Units VI and VII, and is briefly summarized here.
    Costs of the proposed approach are discussed in Units VI.C.1 and 
VII.C.1. Alternatives to TCE are readily available at similar cost and 
performance. Blenders of TCE aerosol degreasers and spot cleaners are 
expected to reformulate their products. Reformulation costs are 
expected to be incurred during the first year and total $286,000 for 
reformulation of dry cleaning spot remover products and total $416,000 
for aerosol degreasing products. Annualized costs of reformulation are 
approximately $32,000 per year (annualized at 3% over 15 years) and 
$41,000 (annualized at 7% over 15 years) for aerosol degreasing, and 
$22,000 per year (annualized at 3% over 15 years) and $28,000 
(annualized at 7% over 15 years) for dry cleaning spot removers. Costs 
to users of aerosol degreasers and dry cleaning spotters are negligible 
as substitute products of similar performance are currently available 
on the market and are similarly priced (Ref. 2). Costs of downstream 
notification and recordkeeping are estimated to cost a total of $51,000 
in the first year. On an annualized basis over 15 years are estimated 
to be approximately $3,900 and $5,000 using 3% and 7% discount rates 
respectively. Agency costs for enforcement are estimated to be 
approximately $112,000 and $109,000 annualized over 15 years at 3% and 
7% respectively. Total costs of the proposed approach to prohibit 
manufacturing, processing, distribution in commerce for use of TCE in 
aerosol degreasing and for spot cleaning in dry cleaning facilities; 
commercial use of TCE in aerosol degreasing and spot cleaning in dry 
cleaning facilities; and require downstream notification and 
recordkeeping are estimated to be approximately $170,000 and $183,000 
annualized over 15 years at 3% and 7% respectively. Total first-year 
costs to industry are estimated to be approximately $874,000 (Ref. 2).
    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 in the overall 
benefits at this time. The monetized benefits for the proposed approach 
range from approximately $9.3 million to $25.0 million on an annualized 
basis over 15 years at 3% and $4.5 million to $12.8 million at 7% (Ref. 
2). There are also non-monetized benefits resulting from the prevention 
of the non-cancer adverse effects associated with TCE exposure from use 
in aerosol degreasing and spot cleaning for dry cleaning. These include 
developmental toxicity, toxicity to the kidney, immunotoxicity, 
reproductive and endocrine effects, neurotoxicity, and toxicity to the 
liver (Ref. 1). The adverse effects of TCE exposure as identified in 
the risk assessment include fetal cardiac malformations that begin in 
utero and fetal death. Cardiac malformations can be irreversible and 
impact a person's health for a lifetime. Other effects, such as damage 
to the developing immune system, may first manifest when a person is an 
adult and can have long-lasting health impacts. Certain effects that 
follow adult exposures, such as kidney and liver cancer, may develop 
many years after initial exposure. Also see Unit VIII.
    Another alternative regulatory option considered was a respiratory 
protection program requiring an air-supplied respirator with an APF of 
10,000. The costs of implementing a respiratory protection program, 
including a supplied-air respirator and related equipment, training, 
fit testing, monitoring, medical surveillance, and related 
requirements, would far exceed the costs of switching to alternatives, 
on a per facility basis. The estimated annualized costs of switching to 
a respiratory protection program requiring personal protective 
equipment (PPE) of 10,000 are $8,200 at 3% and $9,000 at 7% per dry 
cleaning facility and $8,300 at 3% and $9,100 at 7% per aerosol 
degreasing facility over 15 years. In addition, there would be higher 
EPA administration and enforcement costs with a respiratory protection 
program than there would be with an enforcement program under the 
proposed approach. The higher costs of this option render this option a 
less cost effective option than the proposed

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approach at addressing the identified unreasonable risks so TCE no 
longer presents such risks.

F. Children's Environmental Health

    This action is consistent with the 1995 EPA Policy on Evaluating 
Health Risks to Children (https://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 TCE Integrated Risk Information System (IRIS) 
assessment concluded that fetal heart malformations are the most 
sensitive developmental toxicity endpoint associated with TCE 
inhalation exposure (Ref. 3). 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; Ref. 1) 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. 1). 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. 33). While the proposed regulatory 
action is protective of the fetal heart malformation endpoint and is 
also protective of cancer risk from chronic exposure, 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. 
1) also meets the 1995 EPA Policy on Evaluating Health Risks to 
Children. Supporting information on TCE exposures and the health 
effects of TCE exposure on children are available in the Toxicological 
Review of Trichloroethylene (Ref. 3) and the TSCA Chemical Work Plan 
Risk Assessment on Trichloroethylene (Ref. 1), as well as Units 
VI.B.1.c and VII.B.1.c of this preamble.

II. Overview of TCE and Uses Subject to This Proposed Rule

A. What chemical is included in the proposed rule?

    This proposed rule would apply to TCE (Chemical Abstract Services 
Registry Number 79-01-6) for use in aerosol degreasing and for spot 
cleaning in dry cleaning facilities.

B. What are the uses of TCE and how can people be exposed?

    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. 1).
    Individuals, including workers, consumers and the general 
population, are exposed to TCE from industrial/commercial, consumer, 
and environmental sources, in different settings such as homes and 
workplaces, and through multiple exposure pathways (air, water, soil) 
and routes (inhalation, ingestion, dermal).
    The majority (about 83.6%) of TCE is used as an intermediate 
chemical for manufacturing refrigerant HFC-134a. This use occurs in a 
closed system that has low potential for human exposure (Ref. 1). EPA 
did not assess this use and is not proposing to regulate this use of 
TCE under TSCA. Much of the remainder, about 14.7 percent, is used as a 
solvent for degreasing of metals. A relatively small percentage, about 
1.7 percent, accounts for all other uses, including TCE use in 
products, such as aerosol degreasers and spot cleaners.
    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. 1). Based on the latest TRI data from 2014, 
the number of users of TCE has significantly 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 uses assessed by EPA that are the subject of this proposal, the 
use of TCE in aerosol degreasing and for spot cleaning in dry cleaning 
facilities, are estimated to represent up to 1.7 percent of total use 
of TCE. Aerosol degreasing is the use of TCE in aerosol spray products 
applied from a pressurized can to remove residual contaminants from 
fabricated parts. Spot cleaning is the use of TCE in dry cleaning 
facilities to clean stained areas on textiles or clothing. These uses 
are discussed in detail in Units VI and VII.

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. 1).
    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. 1). EPA's Integrated Risk 
Information System (IRIS) assessment (Ref. 3) 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. 3).
    An evaluation of the overall weight of the evidence of the human 
and animal developmental toxicity data suggests an association between 
pre- and/or post-natal TCE exposures and potential adverse 
developmental outcomes. TCE-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: Fetal 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 growth, survival, developmental 
neurotoxicity, developmental immunotoxicity, and childhood cancers. 
Some epidemiological studies reported an increased incidence of birth 
defects in TCE-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

[[Page 91596]]

newborn reflexes, impaired learning or memory, aggressive behavior, 
hearing impairment, speech impairment, encephalopathy, impaired 
executive and motor function and attention deficit disorder (Ref. 1).
    Immune-related effects following TCE exposures have been observed 
in adult animal and human studies. In general, these effects were 
associated with inducing enhanced immune responses 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-exposed workers developing a severe 
hypersensitivity skin disorder, often accompanied by systemic effects 
to the lymph nodes and other organs, such as hepatitis (Ref. 1).
    Studies in both humans and animals have shown changes in the 
proximal tubules of the kidney following exposure to TCE (Ref. 1). The 
TCE IRIS 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. 3). A recent review of TCE by the 
International Agency for Research on Cancer (IARC) also supported this 
conclusion (Ref. 4). The 13th report on carcinogens (RoC) by the 
National Toxicology Program also concluded that TCE is reasonably 
anticipated to be a human carcinogen 2015 (Ref. 5). These additional 
recent peer reviews are consistent with EPA's classification that TCE 
is carcinogenic to humans by all routes of exposure based upon strong 
epidemiological and animal evidence (Refs. 1 and 3).
    TCE metabolites appear to be the causative agents that induce renal 
toxicity, including cancer. S-dichlorovinyl-L-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-treated animals showed the same type of kidney 
damage as those treated with TCE (Ref. 1). The toxicokinetic data and 
the genotoxicity of DCVC further suggest that a mutagenic mode of 
action is involved in TCE-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. 1).
    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. 1).
    Neurotoxicity has been demonstrated in animal and human studies 
under both acute and chronic exposure conditions. Evaluation of 
multiple human studies revealed TCE-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-related symptoms such as headaches, dizziness, and nausea 
following TCE exposure (Ref. 1).
    Animals and humans exposed to TCE consistently experience liver 
toxicity. Specific effects include the following structural changes: 
Increased liver weight, increase in DNA synthesis (transient), enlarged 
hepatocytes, enlarged nuclei, and peroxisome proliferation. Several 
human studies 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-related generalized 
skin diseases, jaundice, hepatomegaly, hepatosplenomegaly, and liver 
failure in TCE-exposed workers (Ref. 1).
    TCE is characterized as carcinogenic to humans by all routes of 
exposure as documented in EPA's TCE IRIS assessment (Ref. 3). 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-
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-
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. 4). The 13th 
Report on Carcinogens (RoC) by the National Toxicology Program also 
concluded that TCE exposure is reasonably anticipated to be a human 
carcinogen (Ref. 5). These additional recent peer reviewed documents 
are consistent with EPA's classification that TCE is carcinogenic to 
humans by all routes of exposure based upon strong epidemiological and 
animal evidence (Refs. 1 and 3).

D. What are the environmental impacts of TCE?

    Pursuant to Section 6(c) of TSCA, EPA in this section describes the 
effects of TCE on the environment and the magnitude of the exposure of 
the environment to TCE. The unreasonable risk preliminary determination 
of this proposal, however, is based solely on risks to human health 
since these risks are the most serious consequence of use of TCE and 
are sufficient to support this proposed action.
    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 (Ref. 1). 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 spot cleaning in dry cleaning facilities and in 
aerosol degreasers. 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

[[Page 91597]]

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. 1).
    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. 1).
    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. 6).
    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. 1).

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 section. 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 final rules and notices 
pertaining to TCE under its various authorities.
     Safe Drinking Water Act: EPA 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 mg/L based on classification as a probable human carcinogen. The 
NPDWR also established an enforceable MCL of 0.005 mg/L based on 
analytical feasibility. 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 designated a hazardous air pollutant 
(HAP) under the Clean Air Act (42 U.S.C. 7412(b)(1)). EPA 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.
     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) today.
    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 exposures 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 
(Refs. 7 and 8). OSHA acknowledges that many of its PELs are not 
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. 9 at p. 61386), including the 
PEL for TCE (Ref. 65).
    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. 10). The American Conference of 
Governmental Industrial Hygienists recommended an 8-hour TWA of 10 ppm 
and acute, or short-term, exposure limit of 25 ppm in 2004 (Ref. 11).

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. 12). 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.

[[Page 91598]]

    In Massachusetts, TCE is a designated high hazard substance, with 
an annual reporting threshold of 1,000 pounds (Ref. 13). Minnesota 
classifies TCE as a chemical of high concern. Many other states have 
considered TCE for similar chemical listings (Ref. 14). 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. 15). Nine states have PELs of 50 ppm (Ref. 15). California's 
PEL of 25 ppm is the most stringent (Ref. 12). All of these PELs are 
significantly higher than the exposures at which EPA identified 
unreasonable risks for TCE use in aerosol degreasers and for spot 
cleaning in dry cleaning facilities 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 is 
prohibited for use in the European Union (EU) as an aerosol degreaser 
and spotting agent at dry cleaning facilities based on its 
classification as a carcinogenic substance (Ref. 16). 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. 16). 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. 16). 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 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. 
None of the applications were for use of TCE in aerosol degreasers or 
for spot cleaning in dry cleaning facilities (Ref. 16).
    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. 17). 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. 17). In 2013, Canada added TCE to 
the Toxic Substances List--Schedule 1 because TCE was found to be toxic 
under conditions (a) and (c) of Section 64(a) of the Canadian 
Environmental Protection Act (CEPA) because it ``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. 18).
    In Japan, the Chemical Substances Control Law considers TCE a Class 
II substance (substances that may pose a risk of long-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. 19). 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. 20).

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 the uses that are the subject 
of this proposed rule. A more detailed discussion of the risks 
associated with each use subject to today's proposed rule can be found 
in Units VI and VII.

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. 21). 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. 22).
    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. 21). 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 draft TCE risk assessment evaluated 
commercial and consumer use of TCE as a solvent degreaser (aerosol 
degreasing and vapor degreasing) and consumer use of TCE as a spray-
applied protective coating for arts and crafts (Ref. 1). In response to 
specific comments and information provided by the peer reviewers, the 
commercial use of TCE as a spotting agent at dry cleaning facilities 
was evaluated, using the near-field/far-field mass balance approach, 
for the

[[Page 91599]]

final risk assessment. The use of TCE in commercial/industrial vapor 
degreasing, and in arts and crafts, is not addressed in today's 
proposal. EPA intends to issue a separate proposed rule on TCE use in 
vapor degreasers at commercial/industrial facilities soon. EPA also 
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).
    The TCE risk assessment evaluated health risks to consumers and 
workers, including occupational bystanders, from inhalation exposures 
to TCE. A summary of the peer review and public comments, along with 
EPA's response, is available in the docket for the risk assessment and 
can be accessed electronically at https://www.regulations.gov/document?D=EPA-HQ-OPPT-2012-0723-0039. While solvent degreasing (both 
aerosol and vapor) is within the scope of the TCE risk assessment, with 
respect to aerosol degreasing, the assessment targeted consumer use of 
specific products. Therefore, using the peer reviewed near-field/far-
field mass balance approach that was used in the risk assessment, EPA 
performed supplemental analyses of worker and bystander inhalation risk 
from TCE aerosol degreaser use in occupational settings. The TCE risk 
assessment identified primary uses of TCE and selected uses including 
aerosol degreasing and spot cleaning in dry cleaning facilities as 
those that were expected to involve frequent or routine use of TCE in 
high concentrations and/or have high potential for human exposure 
(Refs. 1, 23, 24, and 25) and therefore were included in the scope of 
the risk assessment. However, this does not mean that EPA determined 
that other uses not included in the TCE risk assessments present low 
risk.
    The TCE risk assessment identified acute non-cancer risks (i.e., 
developmental effects) for most occupational and consumer exposure 
scenarios, including commercial vapor degreasing, spot cleaning, and 
consumer aerosol degreasing exposure scenarios (Ref. 1). For chronic 
non-cancer risks there is a range of human health effects in both the 
occupational vapor degreasing and spot cleaning exposure scenarios with 
the greatest concern for developmental effects (i.e., fetal cardiac 
defects), as well as kidney effects and immunotoxicity. In addition, 
there are chronic non-cancer risks for adverse reproductive effects, 
neurotoxicity, and liver toxicity (Ref. 1).
    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 (NOAEL) 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 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. 26). 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 TCE risk assessment estimated acute non-cancer risks for 
consumers and residential bystanders from the use of TCE-containing 
aerosol degreasers and spray-applied protective coatings. Exposure 
scenarios with MOEs below the benchmark MOE have significant risks of 
concern and typically, non-cancer adverse effects are more likely to 
result from exposure scenarios with MOEs below the benchmark MOE. For 
non-cancer effects EPA estimated exposures that are significantly 
larger than the point of departure. The TCE risk assessment also 
estimated acute non-cancer risk for workers and occupational bystanders 
for uses including spot cleaning in dry cleaning facilities.
    The TCE risk assessment also estimated chronic non-cancer risk for 
workers and occupational bystanders for uses including spot cleaning in 
dry cleaning facilities. These include developmental toxicity, toxicity 
to the kidney, immunotoxicity, reproductive and endocrine effects, 
neurotoxicity, and toxicity to the liver.
    There are also cancer risks for persons occupationally exposed to 
TCE when using TCE-containing spot cleaners in dry cleaning facilities. 
For users of TCE-containing spot cleaning products, these cancer risks 
are 1.35 x 10 -2 for spot cleaning. In the supplemental 
analysis following the TCE risk assessment, EPA also identified acute 
and chronic non-cancer and cancer risks for the commercial aerosol 
degreasing use scenario for workers and occupational bystanders using 
aerosol degreasers (Ref. 23).
    The levels of acute and chronic exposures estimated to present low 
risk for non-cancer effects also result in low risk for cancer.
    Given the risks identified in the TCE risk assessment, the agency 
undertook further analysis to help determine whether the use of TCE for 
spot cleaning in dry cleaning facilities and in aerosol degreasers 
poses an unreasonable risk.

C. Supplemental Analysis Using the Methodology of the TCE Risk 
Assessment

    Because the TCE risk assessment concentrated on consumer use of 
aerosol degreasers and because the aerosol degreaser products available 
to consumers are also available to commercial users, following release 
of the TCE risk assessment, EPA analyzed the risk to workers and 
occupational bystanders from commercial use of TCE-containing aerosol 
degreasers and identified short-term and long-term non-cancer and 
cancer risks for the commercial aerosol degreasing use scenario (Ref. 
23). This analysis is consistent with the scope of the TCE risk 
assessment and was based on the peer-reviewed near-field/far-field mass 
balance approach that was used in the TCE risk assessment (Ref. 1). EPA 
also conducted supplemental analyses of various parameters of exposure 
scenarios, consistent with the methodology used in the risk assessment, 
on the use of TCE-containing aerosol degreasers by consumers and use of 
TCE for spot cleaning in dry cleaning facilities. 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 Aerosol 
Degreasing'' (Ref. 25) and the exposure assessment for TCE use in spot 
cleaning in dry cleaning facilities in the ``TSCA Work Plan Chemical 
Risk Assessment. Trichloroethylene: Degreasing, Spot Cleaning and Arts 
& Crafts Uses'' (Ref. 1).

[[Page 91600]]

D. Expert Meeting on TCE

    On July 29, 2014, EPA held a 2-day public workshop on TCE 
degreasing (Ref. 27). 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. 27) 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 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 (Ref. 2). The discussions of the meeting demonstrated 
that alternatives are available for aerosol uses that are being 
addressed in this proposed rulemaking.

V. Regulatory Approach

A. TSCA Section 6 Unreasonable Risk Analysis

    Under section 6(a) of TSCA, 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 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)).
     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 section 6(a) 
for each use in order to determine the proposed regulatory approach 
(Refs. 28 and 29). For each use, EPA considered whether a regulatory 
option (or combination of options) would address the identified 
unreasonable risks so that it no longer presents such risks. To do so, 
EPA initially analyzed whether the regulatory options could reduce 
risks (non-cancer and cancer) so that TCE no longer presents 
unreasonable risks, based on EPA's technical analysis of exposure 
scenarios. For the non-cancer risks, EPA determined 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. 
In determining whether a regulatory option would impose requirements to 
the extent necessary so that TCE 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. Section 6(c)(2) considerations. As noted previously, TSCA 
section 6(c)(2) requires EPA to factor in, to the extent practicable, 
the following considerations in selecting regulatory requirements:
     Health effects of 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 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 regulatory options and consideration of the 
TSCA section 6(c)(2) factors are discussed in more detail in Unit VI 
for aerosol degreasing and in Unit VII for spot cleaning in dry 
cleaning facilities.
    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., residual risk risks from 
chemical substitutions and alternative practices), the relative risk 
for environmental justice populations and children or other susceptible 
subpopulations (as compared to the general population), and the cost of 
regulatory requirements for the various options.
    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 (Ref. 
30). EPA took into account the 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). 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.

C. Regulatory Options Receiving Limited Evaluation

    As discussed previously, EPA analyzed a wide range of regulatory 
options under TSCA section 6(a). Early in the process, EPA identified 
two

[[Page 91601]]

regulatory options under section 6(a) that do not pertain to this 
action and were therefore not evaluated for this proposed rulemaking. 
First, EPA determined that the TSCA section 6(a)(1) regulatory option 
to prohibit the manufacture, processing or distribution in commerce of 
TCE or limit the amount of TCE which may be manufactured, processed or 
distributed in commerce is not applicable because the Agency is not 
proposing to ban or limit the manufacture, processing or distribution 
in commerce of TCE for uses other than in aerosol degreasing or for 
spot cleaning in dry cleaning facilities at this time. In addition, EPA 
determined 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 assess risks associated with TCE 
disposal.
    Another option EPA evaluated would require warning labels and 
instructions on TCE-containing aerosol degreasers and for spot cleaning 
in dry cleaning facilities pursuant to section 6(a)(3) (Refs. 28 and 
29). The Agency determined that warning labels and instructions alone 
could not mitigate the risks to the extent necessary so that TCE no 
longer presents the identified unreasonable risks to users. The Agency 
based this determination on an analysis of 48 relevant studies or meta-
analyses, which found that consumers and professionals do not 
consistently pay attention to labels; consumers and professional users 
often do not understand label information; consumers and professional 
users often base a decision to follow label information on previous 
experience and perceptions of risk; even if consumers and professional 
users have noticed, read, understood, and believed the information on a 
hazardous chemical product label, they may not be motivated to follow 
the label information, instructions, or warnings; and consumers and 
professional users have varying behavioral responses to warning labels, 
as shown by mixed results in studies (Ref. 37).
    These conclusions are based on the weight-of-evidence analysis that 
EPA conducted of the available literature on the efficacy of labeling 
and warnings. This analysis indicates that a label's effectiveness at 
changing user behavior to comply with instructions and warnings depends 
not only on attributes of the label and the user, but also on the 
multiple steps required in the processes of attention, comprehension, 
judgment, and action (Ref. 37).
    Numerous studies have found that product labels and warnings are 
effective to some degree. However, the extent of the effectiveness has 
varied considerably across studies and some of the perceived 
effectiveness may not reflect real-world situations. This is because 
interactions among labels, users, the environment, and other factors 
greatly influence the degree of a label's effectiveness at changing 
user behavior (Ref. 37). In addition, while some studies have shown 
that different components of labels and warnings tend to have some 
influence, the evidence does not suggest that labels alone would be 
sufficient to ensure that users take the steps needed to protect 
themselves.
    The Agency further determined that presenting information about TCE 
on a label would not adequately address the identified unreasonable 
risks because the nature of the information the user would need to 
read, understand, and act upon is extremely complex. When the 
precaution or information is simple or uncomplicated (e.g., do not mix 
this cleaner with bleach or do not mix this cleaner with ammonia), it 
is more likely the user will successfully understand and follow the 
direction. In contrast, it would be challenging to most users to follow 
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, and window periods during pregnancy when the 
developing fetus is susceptible to adverse effects from acute 
exposures, as well as effects to bystanders. It is unlikely that label 
language changes will for this use result in widespread, consistent, 
and successful adoption of risk reduction measures by users.
    Additionally, any use of labels to promote or regulate safe product 
use should be considered in the context of other potential risk 
reduction techniques. As highlighted by a 2014 expert report for the 
Consumer Product Safety Commission (CPSC), ``safety and warnings 
literature consistently identify warnings as a less effective hazard-
control measure than either designing out a hazard or guarding the 
consumer from a hazard. Warnings are less effective primarily because 
they do not prevent consumer exposure to the hazard. Instead, they rely 
on persuading consumers to alter their behavior in some way to avoid 
the hazard'' (Ref. 38).
    While this regulatory option alone does not address the risks, EPA 
recognizes that the section 6(a)(3) warnings and instruction 
requirement can be an important component to an approach for addressing 
unreasonable risks associated with TCE use in aerosol degreasers and 
for spot cleaning in dry cleaning facilities and has included a very 
simple downstream notification requirement as part of the proposed 
rulemaking.

VI. Regulatory Assessment of TCE Use in Aerosol Degreasing

    This Unit describes the current use of TCE in aerosol degreasing, 
the unreasonable risks presented by this use, and how EPA preliminarily 
determined which regulatory options are necessary to address those 
unreasonable risks.

A. Description of the Current Use

    Aerosol degreasing is a process that uses aerosol spray products, 
typically applied from a pressurized can, to remove residual 
contaminants from parts. The aerosol droplets bead up on the fabricated 
part and then drip off, carrying away any contaminants and leaving 
behind a clean surface. Components of an item can be cleaned in place 
or removed from the item for more thorough cleaning. Aerosol degreasers 
can also be sprayed onto a rag that is used to wipe components clean.
    Aerosol degreasers are primarily used for niche industrial or 
manufacturing uses and some commercial service uses, such as degreasing 
of metals, degreasing of electrical motors, and electronic cleaners. 
One example of a commercial setting for the aerosol degreaser use is 
repair shops, where service items are cleaned to remove any 
contaminants that would otherwise compromise the item's operation. 
Internal components may be cleaned in place or removed from the item, 
cleaned, and then re-installed once dry. EPA identified 16 different 
aerosol spray degreaser products that contain TCE, blended by 6 
different firms. EPA estimates that about 2,200 commercial facilities 
use TCE aerosol spray degreasers (Ref. 2). EPA requests comment on uses 
of TCE aerosol degreasers and TCE aerosol degreasing products that the 
agency did not identify.
    Consumer use of TCE in aerosol degreasers is similar to commercial 
use but occurs in consumer settings. The aerosol products used in 
consumer settings are the same as those used in commercial settings. 
TCE use is very limited in products intended for consumers due to 
existing VOC regulations in California and in a number of northeast, 
mid-Atlantic, and Midwestern states. Consumer Specialty Products 
Association (CSPA) member

[[Page 91602]]

companies have consistently stated that they do not formulate TCE to be 
sold into consumer products, and the products are generally only sold 
in the commercial supply chains (Ref. 31). However, due to the wide 
availability of products available on the Internet and through various 
suppliers that serve commercial and consumer customers, consumers are 
able to purchase aerosol degreasing products containing TCE. As a 
result, EPA evaluated consumer exposures to aerosol degreasers 
containing TCE in its TCE risk assessment, and identified potential 
risks to consumers from aerosol degreasers.
    There are currently TCE alternatives available on the market for 
all of the existing uses of aerosol degreasing that are similar in 
efficacy and cost (Refs. 2, 32). The most likely substitute products 
would be products with hydrocarbon/mineral spirits, products that are 
acetone or terpene based, and some that contain perchloroethylene or 1-
bromopropane. All substitutes are expected to be less hazardous than 
TCE. Substitutes that are hazardous but at dose levels higher than the 
dose levels at which TCE causes adverse effects include 
perchloroethylene and 1-bromopropane. EPA does not advocate that 
perchloroethylene or 1-bromopropane be used as substitutes. EPA 
released a draft risk assessment for 1-bromopropane on March 3, 2016. 
The schedule for finalizing the assessment of 1-bromopropane and other 
chemicals is still under development. Many substitutes are expected to 
be significantly less hazardous than TCE, based on currently available 
information. These include formulations that may be categorized as 
acetone-, citrus terpene-, hydrocarbon-, and water-based degreasers. 
Several formulations are made with chemicals that are expected to have 
lower relative exposure potential, compared to TCE, based on currently 
available information. These include citrus terpenes and water-based 
degreasers. EPA has not developed risk estimates related to the use of 
substitutes, however, the benefits analysis incorporates the potential 
for certain alternatives to result in risks to users by assuming no 
benefits for TCE users that switch to perchloroethylene or 1-
bromopropane alternatives in its lower estimate for benefits. EPA 
estimates that 25% of TCE users will substitute perchloroethylene or 1-
bromopropane, 50% will substitute hydrocarbon/mineral spirits, and 25% 
will substitute acetone/terpene alternatives (Ref. 2). Although some 
substitutes, including perchloroethylene and 1-bromopropane, are 
hazardous, effects from these chemicals are generally seen at levels 
that are higher than the levels that are associated with TCE toxicity. 
Thus, considering similar exposure potentials for substitutes, the 
overall risk potential for the substitutes will be less than for TCE 
(Ref. 32).

B. Analysis of Regulatory Options

    In this section, EPA explains how it determined whether the 
regulatory options considered would address the unreasonable risks 
presented by this use. First, EPA characterizes the unreasonable risks 
associated with the current use of TCE in aerosol degreasing. 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 
section 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 acute non-cancer risks for consumers and 
residential bystanders from the use of TCE-containing aerosol 
degreasers (Ref. 1). EPA performed supplemental analysis consistent 
with the methodology used for the consumer use scenario included in the 
TCE risk assessment (Ref. 24), and identified acute and chronic non-
cancer risks and cancer risks for the commercial aerosol degreasing use 
scenario (Ref. 23). EPA estimates that there are approximately 10,800 
workers and occupational bystanders at commercial aerosol degreasing 
operations, and approximately 22,000 consumers and bystanders exposed 
to TCE during the consumer use of aerosol degreasers (Ref. 2).
    b. Impacts on minority populations. There is no known 
disproportionate representation of minority populations in occupations 
using aerosol degreasers. All employees and consumers using aerosol 
degreasers would benefit from risk reduction.
    c. Impacts on children. EPA has concerns for effects on the 
developing fetus from acute and chronic worker and consumer maternal 
exposures to TCE. The risk estimates are focused on pregnant women 
because one of the most sensitive health effects associated with TCE 
exposure from the use of consumer and commercial aerosol degreasers is 
adverse effects on the developing fetus. The potential for exposure is 
significant because approximately half of all pregnancies are 
unintended. If a pregnancy is not planned before conception, a woman 
may not be in optimal health for childbearing (Ref. 33). The pregnancy 
estimate includes women who have live births, induced abortions, and 
fetal losses (Ref. 2).
    EPA also examined acute risks for consumer exposures in residential 
settings. EPA assumed that affected consumers would be individuals that 
intermittently use TCE aerosol degreasers in and around their homes, 
whereas bystanders would be individuals in close proximity to the use 
activity but not using the product. EPA assumed that consumer users 
would generally be adults of both sexes (16 years old and older, 
including women of childbearing age), although exposures to teenagers 
and even younger individuals may be possible in residential settings as 
bystanders. However, risk estimates focused on pregnant women. This is 
because one of the most sensitive health effects associated with TCE 
exposure is adverse effects on the developing fetus (Ref. 3).
    d. Exposures for this use. For consumer exposures, EPA used the 
Exposure and Fate Assessment Screening Tool Version 2/Consumer Exposure 
Module to estimate TCE exposures for the consumer use scenarios (Ref. 
1). This modeling approach was selected because emissions and 
monitoring data were not available for the aerosol degreasing TCE uses 
under consideration. The model used a two-zone representation of a 
house to calculate potential TCE exposure levels for consumers and 
bystanders. The modeling approach integrated assumptions and input 
parameters about exposure duration, the chemical emission rate over 
time, the volume of the house and the room of use, the air exchange 
rate and interzonal airflow rate. The model also considered the exposed 
individual's location as it relates to use, body weight, and inhalation 
rate during and after the product use (Ref. 1). No respirator scenarios 
were considered for use by consumers because EPA cannot require use of 
respirators by consumers under TSCA section 6(a). EPA used both an air 
exchange rate of 0.45 per hour based on the central tendency 
ventilation rate for a home in the United States and a higher 
ventilation rate (1.26 air exchanges per hour, representing the upper 
10% of U.S. homes) to represent use of the TCE aerosol degreaser in a 
well-ventilated space (Refs. 1, 24). EPA also considered a range of 
concentrations of TCE in the aerosol

[[Page 91603]]

degreasers that the consumers used (5% to 90%) (Refs. 1, 24). In the 
modeling, TCE in the aerosol degreaser entered the room air through 
overspray of the product and evaporation from a thin film. The 
inhalation acute dose rates were computed iteratively by calculating 
the peak concentrations for each simulated 1-second interval and then 
summing the doses over 24 hours to form a 24-hour dose (Ref. 1).
    The high-end inhalation exposure estimates for the consumer 
scenarios were 2 ppm for users of TCE-containing aerosol degreasers and 
0.8 ppm for bystanders of TCE-containing solvent degreasers (Ref. 1).
    For exposures in commercial settings, EPA determined baseline 
exposures 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 (Ref. 23). The near-field/far-
field model estimates airborne concentrations in a near field (a zone 
close to the source of exposure) and a far field (a zone farther from 
the source of exposure but within the occupational building). EPA used 
these estimated airborne concentrations to estimate 8-hour time 
weighted average exposures for workers (i.e., in the near field) and 
occupational bystanders (i.e., in the far field). A worker is defined 
as the person performing the task in which TCE is used. Occupational 
bystanders are defined as other people within the building who are not 
performing the TCE-based task. Details of the modeling and estimation 
method for calculating exposure levels during aerosol degreasing are 
available in the analysis document, Supplemental Occupational Exposure 
and Risk Reduction Technical Report in Support of Risk Management 
Options for Trichloroethylene (TCE) Use in Aerosol Degreasing (Ref. 
23). As discussed in Unit IV.C, this analysis is based on the 
methodology used in the peer reviewed TCE risk assessment (Ref. 1).
    EPA assumed that a worker applies aerosol degreasers 260 days a 
year, once per hour, and that no applications occur during the first 
hour of the 8-hour work day. EPA also assumed that aerosol degreasing 
facilities use 192.2 grams of degreaser per day and for 100% TCE 
degreaser this would be 27.5 grams of TCE per application. For 
degreasers with differing concentrations of TCE, the per-application 
quantity was adjusted accordingly (Refs. 1 and 23).
    e. Risks for this use. As discussed in Unit IV.B, TCE is associated 
with a range of non-cancer adverse health effects in humans and animals 
and is carcinogenic to humans. MOEs were used in this assessment to 
estimate non-cancer risks for acute and chronic exposures. Exposure 
scenarios with MOEs below the benchmark MOE for the individual toxicity 
endpoints have risks of concern, as explained in detail in the TCE risk 
assessment (Ref. 1). Cancer risks express the incremental probability 
of an individual developing cancer over a lifetime as a result of 
exposure to TCE under specified use scenarios.
    The acute inhalation risk assessment used developmental toxicity 
data to evaluate the acute risks for the TCE use scenarios. As 
indicated in the TSCA Work Plan Risk Assessment on TCE, EPA's policy 
supports the use of developmental studies to evaluate the risks of 
acute exposures. This science-based policy is based on the presumption 
that a single exposure of a chemical at a critical window of fetal 
development, as in the case of cardiac malformation, may produce 
adverse developmental effects (Ref. 34 and 35). EPA reviewed multiple 
studies for suitability for acute risk estimation including a number of 
developmental studies of TCE exposure and additional studies of TCE 
metabolites administered developmentally (Appendix N) (Ref. 1). EPA 
based its acute risk assessment on the most sensitive health endpoint 
(i.e., fetal heart malformations; Ref. 1) representing the most 
sensitive human life stage (i.e., the developing fetus). The acute risk 
assessment used the physiologically based pharmacokinetic (PBPK)-
derived hazard values (HEC50, HEC95, or HEC99; HECXX is the Human 
Equivalent Concentration at a particular percentile) from the Johnson 
et al. (2003) (Ref. 36) developmental toxicity study for each aerosol 
degreaser use scenario. Note that the differences among these hazard 
values is small and no greater than 3-fold (i.e., 2-fold for HEC50/
HEC95 ratios; 3-fold for HEC50/HEC99 ratios; 1.4-fold for HEC95/HEC99 
ratios). The TCE IRIS assessment preferred the HEC99 for the non-cancer 
dose-response derivations because the HEC99 was interpreted to be 
protective for a sensitive individual in the population. While the 
HEC99 was used to determine the level of risk to be used in making the 
preliminary section 6(a) determination, the small variation among 
HEC50, HEC95 and HEC99 would not result in a different risk 
determination.
    Acute inhalation risks were estimated for all residential exposure 
scenarios of aerosol degreasing based on concerns for developmental 
effects. Risks of concern were identified for consumer users and 
bystanders, regardless of the type of exposure (typical vs. worst case 
scenario) and whether room ventilation was used. For acute consumer 
aerosol degreasing exposures, the high end MOE is 0.002 for fetal heart 
malformations. This means that exposures are estimated to be 5,000 
times greater than exposures used to calculate the benchmark MOE of 10. 
All of the residential use scenarios resulted in MOE values 
significantly below the benchmark MOE of 10 irrespective of the 
percentile HEC value used to estimate the MOEs (Refs. 1, 24). Given 
this significant difference between the benchmark MOEs and the MOEs 
from the residential use scenarios, EPA has preliminarily determined 
that the risks TCE present for the consumer aerosol degreasing use are 
unreasonable risks.
    For occupational aerosol degreasing exposures the MOE is 0.003 for 
fetal heart malformation and is also representative of MOEs for kidney 
toxicity and immunotoxicity. This equates to estimated exposures that 
are more than 3,000 times greater than those needed to achieve the 
benchmark MOE. For chronic occupational aerosol degreasing exposures 
the baseline cancer risk is 1.6 x 10 -2 exceeding standard 
cancer benchmarks of 10 -6 to 10 -4 (Refs. 1, 
23). EPA has preliminarily determined that TCE presents unreasonable 
risks for the occupational aerosol degreasing use.
    2. Initial analysis of potential regulatory options. Having 
identified unreasonable risks from the use of TCE in aerosol 
degreasing, EPA evaluated whether regulatory options under 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 determine variations in TCE exposure from 
aerosol degreasing, including: Material substitution, engineering 
controls, and use of PPE. EPA also assessed combinations of these 
options. The material substitution scenarios involved reducing the 
concentration of TCE in the degreasing formulation, with concentrations 
varying from 5 to 95 percent by weight in the product. For the 
engineering controls risk reduction option exposure scenarios, EPA 
evaluated using local exhaust ventilation to improve ventilation near 
the worker activity, with estimated 90% reduction in exposure levels. 
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 all 
combinations of the above three options: Material substitution plus 
PPE, material

[[Page 91604]]

substitution plus engineering controls such as local exhaust 
ventilation, PPE plus engineering controls such as local exhaust 
ventilation, and materials substitution plus PPE plus engineering 
controls such as local exhaust ventilation.
    EPA's inhalation exposure modeling estimated exposures to 
characterize the range of workplace scenarios. Inhalation exposure 
level estimate for facilities without local exhaust ventilation ranged 
from 1.00 ppm to 14.36 ppm as 8-hour TWAs for workers and 0.21 ppm to 
13.58 ppm for bystanders. For facilities with local exhaust ventilation 
which was estimated to have an effectiveness of 90%, EPA's inhalation 
exposure level estimates were 0.586 ppm for workers and 0.507 ppm for 
bystanders. This estimate was for the 99th percentile and assumed that 
the aerosol degreaser was 100% TCE and that no PPE was used. The 
exposure estimates for wearing PPE combined with facilities having 
local exhaust ventilation ranged from 0.0000586 ppm to 0.0586 ppm for 
workers and 0.0000507 ppm to 0.0507 ppm for bystanders. The range 
represents the 10 to 10,000 range of respirator APFs considered. The 
exposure estimates for material substitution plus local exhaust 
ventilation ranged from 0.0293 ppm to 0.556 ppm for workers and 0.0253 
ppm to 0.482 ppm for bystanders. The range represents the various TCE 
concentrations (5% to 95%) considered for material substitution. 
Additional exposure level estimates for various scenarios are available 
in the analysis document Supplemental Occupational Exposure and Risk 
Reduction Technical Report in Support of Risk Management Options for 
Trichloroethylene (TCE) Use in Aerosol Degreasing (Ref. 23).
    Overall, EPA evaluated dozens of distinct exposure scenarios. The 
results indicate that regulatory options such as reducing the 
concentration of TCE in aerosol degreasers and using local exhaust 
ventilation to improve ventilation near worker activity, in the absence 
of PPE could not achieve the target MOE benchmarks for non-cancer 
endpoints for acute and chronic exposures and standard cancer risk 
benchmarks for chronic exposures (Refs. 23 and 24). The results also 
demonstrate that all risk reduction options meeting the benchmark MOEs 
and cancer benchmarks for TCE aerosol degreasers require the use of a 
respirator, whether used alone or in conjunction with additional levels 
of protection. Therefore, EPA found options setting a maximum 
concentration in products under section 6(a)(2) to not be protective 
because the options failed--by orders of magnitude--to meet the risk 
benchmarks. Options found not to meet the risk benchmarks and, 
therefore, found not to address the identified unreasonable risks are 
documented in EPA's supplemental technical reports on aerosol 
degreasing (Refs. 23 and 24).
    3. Assessment of regulatory options to determine whether they 
address the identified unreasonable risks to the extent necessary so 
that TCE no longer presents such risks. As discussed in Unit V, EPA 
considered a number of regulatory options under section 6(a) which are 
reflected in EPA's supporting analysis (Refs. 28 and 29). In assessing 
these options, EPA considered a wide range of exposure scenarios (Refs. 
23, 24, 25). These include both baseline and risk reduction scenarios 
involving varying factors such as exposure concentration percentiles, 
local exhaust ventilation use, respirator use, working lifetimes, etc. 
As part of this analysis, EPA considered the impacts of regulatory 
options on consumer users and commercial users separately. However, EPA 
is proposing to address the aerosol degreasing use as a whole rather 
than as separate consumer and commercial uses given that the 
differences in the use itself between workers and consumers differ only 
in the degree of repetition and duration and, furthermore, that not 
addressing them jointly would facilitate products intended for one 
segment being intentionally or unintentionally acquired and misused by 
the other.
    The options that had the potential to address the identified 
unreasonable risks for consumer use, commercial use, or both uses of 
TCE in aerosol degreasing included: (a) Prohibiting the manufacturing, 
processing, and distribution in commerce of TCE for use in aerosol 
degreasing under section 6(a)(2) plus prohibiting the use of TCE in 
commercial aerosol degreasing under section 6(a)(5) and requiring 
downstream notification when distributing TCE for other uses under 
section 6(a)(3); (b) variations on such a supply-chain approach (such 
as just prohibiting the manufacturing, processing, and distribution in 
commerce of TCE for use in aerosol degreasing products under section 
6(a)(2) or just prohibiting the commercial use of TCE in aerosol 
degreasing under section 6(a)(5)); (c) prohibiting the manufacturing, 
processing, and distribution in commerce of TCE for use in consumer 
aerosol degreasing products under section 6(a)(2) and requiring 
downstream notification (e.g., via a Safety Data Sheet (SDS)) when 
distributing TCE for other uses under section 6(a)(3); and (d) 
requiring the use of PPE in commercial aerosol degreasing operations in 
which TCE is used under section 6(a)(5) or requiring the use of PPE and 
engineering controls (local exhaust ventilation) in commercial aerosol 
degreasing operations in which TCE is used under section 6(a)(5).
    The full range of regulatory options considered under section 6(a) 
is reflected in EPA's supporting analysis (Ref. 29). A discussion of 
those regulatory options that could reach the risk benchmarks for 
consumer use, commercial use, or both is provided in this Unit, along 
with the Agency's evaluation of how well those regulatory options would 
address the identified unreasonable risks in practice.
    a. Proposed approach to prohibit manufacturing, processing, 
distribution in commerce, and use of TCE for aerosol degreasing and 
require downstream notification. As noted previously, the proposed 
regulatory approach for TCE use in aerosol degreasing would prohibit 
the manufacturing, processing, and distribution in commerce of TCE for 
aerosol degreasing under TSCA section 6(a)(2), prohibit the commercial 
use of TCE for aerosol 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 prohibitions under TSCA section 6(a)(3).
    As discussed in Unit VI.B.1, the baseline risk for exposure to 
workers and consumers for aerosol degreasing departs from non-cancer 
MOE benchmarks for all non-cancer effects (e.g., developmental effects, 
kidney toxicity, and immunotoxicity) and standard cancer benchmarks. 
Under this proposed approach, exposures to TCE from use in aerosol 
degreasing would be completely eliminated. As a result, both non-cancer 
and cancer risks would be eliminated (Refs. 23 and 24).
    The proposed approach would ensure that workers and consumers are 
no longer at risk from TCE exposure associated with this use. 
Prohibiting the manufacturing, processing and distribution in commerce 
of TCE for use in aerosol degreasing would minimize the availability of 
TCE for aerosol degreasing. The prohibition of the use of TCE in 
commercial aerosol degreasing would eliminate commercial demand for TCE 
aerosol degreasing products and significantly reduce the potential for 
consumer use of commercial products. These complementary provisions 
would protect both workers and consumers; workers would not be exposed 
to TCE and the risk to consumers would be

[[Page 91605]]

minimized because commercial aerosol degreasing products containing TCE 
would not be available, so consumers would not be able to divert 
commercial-use products from the supply chain. The downstream 
notification of these restrictions ensures that processors, 
distributors, and other purchasers are aware of the manufacturing, 
processing, distribution in commerce and use restrictions for TCE in 
aerosol degreasing, and helps to ensure that the rule is effectively 
implemented by avoiding off-label use as an aerosol degreaser of TCE 
manufactured for other uses. Downstream notification also streamlines 
and aids in compliance and enhances enforcement. Overall, downstream 
notification facilitates implementation of the rule. This integrated 
supply chain proposed approach minimizes the risk from TCE in aerosol 
degreasing. In addition, the proposed approach would provide staggered 
compliance dates for implementing the prohibition of manufacturing, 
processing, distribution in commerce, and commercial use in order to 
avoid undue impacts on the businesses involved.
    b. Options that are variations of the proposed approach to prohibit 
manufacturing, processing, distribution in commerce, and use of TCE for 
aerosol degreasing and require downstream notification. One variation 
of the proposed approach would be to prohibit manufacture, processing, 
and distribution in commerce for the consumer and commercial aerosol 
degreasing uses alone. This option could reach the risk benchmarks for 
TCE. However, while this option could address the identified 
unreasonable risks, in practice given the continued availability of TCE 
for other uses, it would not do so. Without the accompanying 
prohibition on commercial use and downstream notification that is 
included in the proposed approach, this option would leave open the 
likelihood that commercial users or consumers could obtain off-label 
TCE for aerosol degreasing. For example, if only manufacturing, 
processing and distribution in commerce for the aerosol degreasing use 
were prohibited without also prohibiting the commercial use and 
providing the downstream notice, commercial users or consumers could 
more easily acquire TCE for degreasing from sources that make it 
available for other uses. This would be particularly easy for 
commercial users given that a company may buy a chemical substance for 
one use and also use it for another. Without downstream notification, 
unsophisticated purchasers, in particular, are likely to be unfamiliar 
with the prohibitions regarding this use and mistakenly use TCE for 
aerosol degreasing and thereby expose themselves and bystanders to 
unreasonable risks. Thus, under these variations, EPA anticipates that 
the risk benchmarks would not actually be realized by many users. 
Therefore, these variations fail to address the identified unreasonable 
risks, considering the practical limitations of the options.
    Another regulatory option that EPA considered was to prohibit only 
the commercial use of TCE for aerosol degreasing. This approach would 
eliminate both non-cancer and cancer risks for commercial settings 
only, but would not eliminate risks to consumers. By prohibiting 
commercial use alone, without a prohibition on the manufacture, 
processing, and distribution in commerce for consumer and commercial 
use, this would not address consumer risks as consumers would still be 
able to purchase aerosol degreasing products containing TCE, including 
those products labeled and marketed as ``professional strength'' or 
``commercial grade'' products. Consumers would continue to be exposed 
far above the health benchmarks and would not be protected from the 
unreasonable risks posed by TCE.
    c. Prohibit the manufacturing, processing, and distribution in 
commerce of TCE for use in consumer aerosol degreasing products under 
section 6(a)(2) or prohibit the manufacturing, processing, and 
distribution in commerce of TCE for use in consumer aerosol degreasing 
products under section 6(a)(2) and require downstream notification when 
distributing TCE for other uses section 6(a)(3). EPA considered 
prohibiting the manufacturing, processing, and distribution in commerce 
of TCE for use in consumer aerosol degreasing products including an 
option with a requirement for downstream notification of such 
prohibition. If such a prohibition were effective, this option would 
mitigate the risks to consumers from TCE use in aerosol degreasing. 
However, EPA has determined that consumers can easily obtain products 
labeled for commercial use. Indeed, for many consumers, identifying a 
product as being for commercial use may imply greater efficacy. Coupled 
with the fact that many products identified as commercial or 
professional are readily obtainable in a variety of venues (e.g., the 
Internet, general retailers, and specialty stores, such as automotive 
stores), EPA does not find that this option would protect consumers. In 
addition, this option alone would not address the risks to workers from 
commercial aerosol degreasing.
    d. Require the use of personal protective equipment in commercial 
aerosol degreasing operations in which TCE is used under section 
6(a)(5) or require the use of personal protective equipment and 
engineering controls in commercial aerosol degreasing operations in 
which TCE is used under section 6(a)(5). Another regulatory option that 
EPA considered was to require respiratory protection equipment at 
commercial aerosol degreasing operations 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. EPA's analysis 
determined that use of a SCBA with an APF of 10,000 for commercial 
aerosol degreasing uses could control TCE air concentration to levels 
that allow for meeting the benchmarks for non-cancer and cancer risks 
for the commercial uses addressed in this proposed rule.
    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-face piece respirators 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 face piece fit, including those individuals whose beards or 
sideburns interfere with the face piece seal, would be unable to wear 
tight fitting respirators. In addition, respirators may also present 
communication problems, vision problems, worker fatigue and reduced 
work efficiency (63 FR 1156, January 8, 1998). 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.'' (63 FR 1189-1190). Nonetheless, it is 
sometimes necessary to use respiratory protection to control

[[Page 91606]]

exposure. The OSHA respiratory protection standard (29 CFR 1910.134) 
requires employers to establish and implement a respiratory protection 
program to protect their respirator wearing employees. This OSHA 
standard contains several 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 has adopted a hierarchy of industrial hygiene 
controls established by the industrial hygiene community to be 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 methods 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 only where 
engineering controls and effective work practices are not feasible or 
during an interim period while such controls are being implemented.
    Also for commercial aerosol degreasing uses, EPA considered 
requiring a combination of local exhaust ventilation and a supplied-air 
respirator with an APF of 1,000, with a performance based option using 
an air exposure limit. This option could also reduce risks to the 
health benchmarks for workers when used properly (Ref. 23). However, 
while this option has the benefit of incorporating engineering controls 
and use of a respirator with a lower APF, there are still the 
limitations to successful implementation of the use of supplied-air 
respirators in the workplace as discussed previously. Further, this 
option would also require the use of prescriptive and expensive 
engineering controls to reach the risk benchmarks, unless the optional 
use of an air exposure limit is implemented (Ref. 39). Even if the 
performance-based option of meeting an air concentration level as an 
exposure limit for TCE were used, this would depend upon the use of 
both engineering controls and a respirator to meet the exposure limit 
for TCE.
    Furthermore, neither of these variations of relying upon PPE for 
commercial aerosol degreasing use would do anything to reduce the risks 
to consumer users. Therefore, considering the practical limitations of 
PPE for this scenario as well as the unmitigated risks to consumers, 
this option would not address the unreasonable risks presented by these 
uses.
    Even if either of these approaches were coupled with a section 
6(a)(2) prohibition on the manufacture, processing and distribution in 
commerce of TCE for use in consumer aerosol degreasing products, this 
would not protect consumers because they would be able to buy and use 
commercial aerosol degreasing products, e.g., via the Internet.
    EPA could also require that TCE products be distributed with a 
respirator with an appropriate assigned protection factor to protect 
for the risks from TCE. EPA determined that this option would not 
address the identified unreasonable risks because simply packaging a 
respirator with a chemical (or any product) does not mean that a worker 
or consumer would actually use it properly or even understand how to 
use it (Refs. 28 and 29).

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

    This Unit examines the availability of substitutes for TCE in 
aerosol degreasing and describes the estimated costs of the proposed 
and alternative regulatory actions that EPA considered. More 
information on the benefits and costs of this proposal as a whole can 
be found in Unit VIII.
    Overall, EPA notes that the cost of aerosol degreasing product 
reformulations are low. Total first-year reformulation costs are 
estimated to be $416,000 and annualized costs are estimated to be 
approximately $32,000 per year (annualized at 3% over 15 years) and 
$41,000 (annualized at 7% over 15 years). A wide variety of effective 
substitutes are available, as previously noted, and the current 
existence of non-TCE containing aerosol degreasers indicates that there 
are no specific aerosol degreasing uses for which TCE is critical. TCE 
use is limited in aerosol degreasing products intended for consumers 
due to existing VOC regulations in California and in a number of other 
states. New Hampshire and Virginia prohibit use of TCE in aerosol 
adhesives. Connecticut, Delaware, the District of Columbia, Illinois, 
Indiana, Maine, Maryland, Massachusetts, Michigan, New York, and Rhode 
Island prohibit the use of TCE in aerosol adhesives, contact adhesives, 
electrical cleaners, footwear/leather care products, adhesive removers, 
general purpose degreasers, and graffiti removers (Ref. 15). New Jersey 
prohibits the use of TCE in all those products and also in brake 
cleaners, engine degreasers, and carburetor/fuel-injection air intake 
cleaners. In addition to prohibiting the use of TCE in all those 
products, California also prohibits the use of TCE in bathroom and tile 
cleaners, construction and panel/floor covering adhesives; carpet/
upholstery cleaner, general purpose cleaners, fabric protectant, multi-
purpose lubricant, penetrant, metal polish or cleanser, multi-purpose 
solvent, oven cleaners, paint thinner, pressurized gas duster, sealant 
or caulking compound, spot remover, and silicone-based multi-purpose 
lubricant (Ref. 12). The range of the State-mandated prohibitions 
demonstrate that other chemicals can be substituted for TCE for a wide 
range of uses because other chemicals or mixtures of chemicals can 
impart properties similar to those of TCE. Further, the fact that 10 
states and the District of Columbia have specifically prohibited the 
use of TCE in general purpose degreasers and general purpose degreasers 
continue to be sold in those jurisdictions, demonstrates that TCE is 
not critical to the degreasing use and there are efficacious 
substitutes.
    TCE is also prohibited in the European Union in aerosol degreasers 
(Ref. 16); TCE substitutes are used for aerosol degreasing. These 
regulations confirm that TCE is not a critical chemical for aerosol 
degreasing and that substituting alternate chemicals would not be 
overly difficult. Producers of aerosol degreasing products containing 
TCE also produce aerosol degreasing products with substitute chemicals. 
Thus, there is already precedent for producers reformulating products 
to meet demand in some states and countries. In addition, EPA expects 
that one effect of a ban on the use of TCE in aerosol degreasing 
products would be increased technological innovation, resulting in the 
development of additional alternatives.
    1. Proposed approach to prohibit manufacturing, processing, 
distribution in commerce, and use of TCE for aerosol degreasing and 
require downstream notification. The costs of the proposed approach are 
estimated to include product reformulation costs, downstream 
notification costs, recordkeeping costs, and Agency costs. The total 
first-year costs of aerosol degreasing product reformulations are 
estimated to be $416,000 and annualized costs are estimated to be

[[Page 91607]]

approximately $32,000 per year (annualized at 3% over 15 years) and 
$41,000 (annualized at 7% over 15 years). The cost for reformulation 
includes a variety of factors such as identifying the substitute for 
TCE, assessing the efficacy of the new formulation and determining 
shelf-life. The costs to users of aerosol degreasers are negligible as 
substitute products are currently available on the market and are 
similarly priced. The first-year costs of downstream notification and 
recordkeeping are estimated to be $51,000 and on an annualized basis 
over 15 years are $3,900 and $5,000 using 3% and 7% discount rates 
respectively (Ref. 2). Agency costs for enforcement are estimated to be 
approximately $112,000 and $109,000 annualized over 15 years at 3% and 
7%, respectively. Annual recurring costs to the Agency for enforcement 
are estimated to be $121,000 per year. The total cost of the proposed 
approach for aerosol degreasing use is estimated to be $37,000-$40,000 
and $46,000-$49,000 annualized over 15 years at 3% and 7%, 
respectively.
    2. Options that require personal protective equipment. Given 
equipment costs and the requirements associated with establishing a 
respiratory protection program which involves training, respirator fit 
testing and the establishment and maintenance of a medical monitoring 
program, EPA anticipates that companies would choose to switch to 
substitute chemicals instead of adopting a program for PPE, including 
with a performance based option of meeting an air concentration level 
as an exposure limit for TCE. The estimated annualized costs of 
switching to a respiratory protection program requiring PPE of APF 
10,000 are $8,300 at 3% and $9,100 at 7% per aerosol degreasing 
facility over 15 years. The estimated annualized costs of switching to 
a respiratory protection program requiring PPE of APF 1,000 are $5,400 
at 3% and $5,500 at 7% per facility over 15 years. In addition, there 
would be higher EPA administration and enforcement costs with a 
respiratory protection program than there would be with an enforcement 
program under the proposed approach. Further, even if cost were not an 
impediment, in addition to cost, 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. EPA was unable to 
monetize the extent to which enforcement costs would vary by regulatory 
option so EPA assumed monetized enforcement costs to be the same under 
all options for the purpose of this proposed rulemaking. The proposed 
approach to prohibit manufacturing, processing, distribution in 
commerce, and use of TCE for aerosol 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 much more 
difficult since the key requirements are directly placed on the large 
number of product users (Ref. 40). Under these other options, 
enforcement activities must target firms that might perform the 
activity where a TCE use is restricted or prohibited. Identifying which 
establishments might use aerosol degreasers is difficult because 
aerosol degreasing is not strictly specific to any industry (Ref. 2). 
Therefore, while EPA considers downstream notification to be a critical 
component of this proposal, EPA also finds that incorporating 
downstream notification reduces the burden on society by easing 
implementation, compliance, and enforcement (Ref. 41).

D. Summary

    The proposed approach to prohibit manufacturing, processing, 
distribution in commerce, and use of TCE for aerosol degreasing and 
require downstream notification is necessary to ensure that TCE no 
longer presents unreasonable risks for all users. This option does not 
pose an undue burden on industry because comparably effective and 
priced substitutes to TCE for aerosol degreasing are readily available. 
The supply chain approach ensures protection of consumers from the 
identified unreasonable risks by precluding the off-label purchase of 
commercial products by consumers. The downstream notification (e.g., 
via SDS) component of the supply chain approach provides notice of the 
prohibition throughout the supply chain and, while slightly more costly 
to upstream entities, helps to ensure that the use no longer presents 
unreasonable risks because it streamlines and aids in compliance and 
enhances enforcement.

VII. Regulatory Assessment of TCE Use for Spot Cleaning in Dry Cleaning 
Facilities

    This Unit describes the current use of TCE for spot cleaning in dry 
cleaning facilities, the unreasonable risks presented by this use, and 
how EPA preliminarily determined which regulatory options are necessary 
to address the identified unreasonable risks.

A. Description of the Current Use

    TCE was first introduced as a dry cleaning solvent in the United 
States in the 1930s (Ref. 2). It was never widely used as a primary dry 
cleaning solvent; however, TCE is still used for spot cleaning in dry 
cleaning facilities to remove oily-type stains, including fats, waxes, 
grease, cosmetics, and paints. Stained fabrics are typically ``pre-
spotted'' with spot treatment products, which are often solvent-based 
such as those containing TCE, prior to being placed in dry cleaning 
machines (Refs. 42, 43). TCE is one of many available spotting agents 
used in dry cleaning facilities. A range of alternative spotting agents 
are used in dry cleaning facilities including certain halogenated 
solvents, such as perchloroethylene, 1-bromopropane, and methylene 
chloride; water- and soy-based spotting agents; hydrocarbon/mineral 
spirits; glycol ethers; and others (Ref. 2). TCE is applied by a squirt 
bottle directly onto the stain on the garment (Ref. 1). Squirt bottles 
are hand filled from larger volume containers of the spotting agent. 
After application, the TCE-based spotting agent is patted with a brush 
to break up the stain without harming fabric and suction vacuumed from 
the garment, which is then placed in the dry cleaning machine. The TCE 
spotting agent from the vacuum is collected as hazardous waste. 
Concentrations of TCE in commercial spotting agents vary from 10% to 
100% (Refs. 42, 43).
    EPA estimates that there are approximately 61,000 dry cleaning 
facilities in the United States, with an estimated 210,000 workers. 
Approximately 32,000 to 52,000 of those dry cleaning facilities are 
estimated to be using TCE in spot cleaning, with an estimated 105,000 
to 168,000 workers and occupational bystanders (Ref. 2). Less than 1% 
of the total 225 million pounds of TCE used in the United States is for 
dry cleaning with approximately 50% to 80% of dry cleaners estimated to 
be using TCE for spot cleaning in dry cleaning facilities (Ref. 2). A 
typical dry cleaning facility uses 0.84 to 8.4 gallons per year of TCE 
for spot cleaning operations (Ref. 1).
    There are currently a wide variety of comparably effective 
substitutes on the market and in use in dry cleaning operations that 
are similarly priced to TCE (Ref. 2), including substitute water-based 
cleaners (Ref. 44), methyl esters (soy) cleaners, hydrocarbon/mineral 
spirits, glycol ethers, perchloroethylene, methylene chloride, and 1-
bromopropane (Ref. 32). Chemical

[[Page 91608]]

substitutes that would most likely be used are water-based cleaners, 
methyl esters (soy) cleaners, hydrocarbon/mineral spirits, glycol 
ethers, perchloroethylene, 1-bromopropane, methylene chloride, and 
others. EPA estimates that 5% of users will switch to aqueous cleaners, 
25% will switch to perchloroethylene and 1-bromopropane, and 70% will 
switch to other alternatives (Ref. 2). In general, substitutes are less 
toxic than TCE (Refs. 32, 44). Thus, considering similar exposure 
potentials for substitutes, the overall risk potential for the 
substitutes will be less than for TCE (Ref. 32).

B. Analysis of Regulatory Options

    In this Unit, EPA explains how it determined whether the regulatory 
options considered would address the unreasonable risks presented by 
this use. First, EPA characterizes the unreasonable risks associated 
with the current use of TCE for spot cleaning in dry cleaning 
facilities. Then, the Agency describes its initial analysis of which 
regulatory options have the potential to achieve non-cancer and cancer 
benchmarks. The levels of acute and chronic exposures estimated to 
present low risk for non-cancer effects also results 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 non-cancer risks and cancer risks for 
chronic exposures of workers and occupational bystanders in dry 
cleaning facilities that use TCE for spot cleaning (Ref. 1). EPA also 
identified acute non-cancer risks for workers and occupational 
bystanders (Ref. 1). The size of the potentially exposed population is 
approximately 105,000-168,000 workers and occupational bystanders in 
dry cleaning operations (Ref. 2).
    b. Impacts on minority populations. In dry cleaning facilities, 
Asian and Hispanic populations are over-represented. 13% of dry 
cleaning workers are Asian, compared to 5% of the national population. 
Also, 30% of dry cleaning workers are Hispanic (of any race) compared 
to 16% of the national population (Ref. 2). Because minority 
populations are disproportionately over-represented in this industry 
they are disproportionately exposed; thus, there would be 
disproportionately positive benefits for these populations from the 
regulatory approach set forth in this proposal.
    c. Impacts on children. EPA has concern for effects on the 
developing fetus from acute and chronic maternal exposures to TCE in 
dry cleaning facilities. The risk estimates are focused on pregnant 
women because adverse effects on the developing fetus is one of the 
most sensitive health effects associated with TCE exposure. Of the up 
to 168,000 workers and occupational bystanders in dry cleaning 
operations who make up the exposed population, 3.2% are estimated to be 
pregnant women. Thus, up to approximately 5,400 pregnant women are 
estimated to be exposed to TCE in spot cleaning in dry cleaning 
facilities each year. The pregnancy estimate includes women who have 
live births, induced abortions, and fetal losses (Ref. 2). The 
potential for exposure is significant because approximately half of all 
pregnancies are unintended. If a pregnancy is not planned before 
conception, a woman may not be in optimal health for childbearing (Ref. 
33).
    d. Exposures for this use. TCE exposures for this use are through 
the inhalation route. EPA used readily available information from a 
2007 study on spotting chemicals, prepared for the California EPA and 
EPA, to estimate releases of TCE and associated inhalation exposures to 
workers from spot cleaning operations in dry cleaning facilities (Ref. 
1). The near field/far field mass balance model, which has been 
extensively peer[hyphen]reviewed, was used for this estimation of 
workplace exposure levels during spot cleaning (Ref. 1). The near-
field/far-field model estimates airborne concentrations in a near field 
(a zone close to the source of exposure) and a far field (a zone 
farther from the source of exposure but within the occupational 
building). EPA used these estimated airborne concentrations to estimate 
exposures for the worker applying the spotting agent (i.e., in the near 
field) and the occupational bystanders (i.e., in the far field). A 
worker is defined as the person performing the task in which TCE is 
used. Occupational bystanders are defined as other persons within the 
dry cleaning facility who are not performing the TCE-based task. EPA 
assumed that dry cleaning facilities operated 260 days per year for 8 
hours a day; that the concentration in the spotting agent ranged from 
10 to 100% and that a typical dry cleaning facility used 0.84 to 8.4 
gallons of TCE per year for spotting operations. Details of the 
modeling and estimation method for calculating exposure levels during 
spot cleaning are available in the TCE risk assessment (Ref. 1).
    e. Risks for this use. As discussed in Unit IV.B, TCE is associated 
with a range of non[hyphen]cancer health effects in humans and animals 
and is also carcinogenic to humans.
    As discussed in Unit IV.B, MOEs were used in this assessment to 
estimate non-cancer risks for acute and chronic exposures. Exposure 
scenarios with MOEs below the benchmark MOE have risks of concern and 
typically, non-cancer adverse effects are more likely to result from 
exposure scenarios with MOEs below the benchmark MOE. For the use of 
TCE as a spot cleaner in dry cleaning facilities, the risk estimates 
for a range of non-cancer effects were below the benchmark MOE of 10 
for developmental effects. The MOE for acute developmental effects is 
0.002 for fetal heart malformation (Refs. 1, 25). For chronic 
occupational spot cleaning exposures, the MOE is 0.003 for fetal heart 
malformation and is similar to MOEs for kidney toxicity and 
immunotoxicity. In the baseline exposure scenarios, the MOEs are 3,000 
times less than the benchmark MOEs (Refs. 1, 25). EPA has preliminarily 
determined that TCE presents unreasonable non-cancer risks from spot 
cleaning in dry cleaning facilities.
    Cancer risks determine the incremental probability of an individual 
developing cancer over a lifetime as a result of exposure to TCE. For 
chronic occupational spot cleaning exposures the baseline cancer risk 
is 1 x 10-\2\ which exceeds the standard cancer benchmarks 
of 10-\6\ to 10-\4\ (Refs. 1 and 25). 
Accordingly, EPA has preliminarily determined that TCE presents 
unreasonable cancer risks from spot cleaning in dry cleaning 
facilities.
    2. Initial analysis of potential regulatory options. Having 
identified unreasonable risks from the use of TCE in spot cleaning in 
dry cleaning facilities, EPA evaluated whether regulatory options under 
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 determine variations in TCE exposure when 
spot cleaning in dry cleaning facilities: Material substitution, 
engineering controls, and use of PPE, as well as combinations. The 
materials substitution scenarios involved reducing the concentration of 
TCE in the spot cleaning formulation, with concentrations varying from 
5% to 95% total weight of the formulation. For the engineering control 
risk reduction option exposure scenarios, EPA evaluated using local 
exhaust ventilation to improve ventilation near the worker activity, 
with estimated 90% reduction in exposure levels. The PPE risk reduction 
option exposure scenarios evaluated workers and

[[Page 91609]]

occupational bystanders wearing respirators with APF varying from 10 to 
10,000. Additionally, EPA evaluated all combinations of the above three 
options: Material substitution plus PPE; material substitution plus 
local exhaust ventilation; PPE plus local exhaust ventilation; and 
material substitution plus PPE plus local exhaust ventilation.
    EPA's site[hyphen]specific inhalation exposure level estimate for 
facilities without local exhaust ventilation ranged from 0.08 to 19 ppm 
as 8-hour TWAs. Although relevant exposure monitoring data were 
limited, EPA identified a study specific to spot cleaning with TCE 
(Ref. 42). In this study, TWA levels for worker exposure to TCE during 
spot cleaning (with no local exhaust ventilation) ranged from 2.37 to 
3.11 ppm. This range of exposure levels falls within EPA's estimated 
exposure range of 0.08 to 19 ppm and is within a factor of 10 of EPA's 
high-end estimate of 19 ppm (Ref. 43).
    For facilities with local exhaust ventilation, EPA's inhalation 
exposure level estimates were 5.0 x 10-\1\ ppm for workers 
and 4.2 x 10-\1\ for bystanders. The exposure estimates for 
wearing PPE combined with facilities having local exhaust ventilation 
ranged from 5.0 x 10-\5\ ppm to 5.0 x 10-\2\ ppm 
for workers and 4.2 x 10-\5\ ppm to 4.2 x 10-\2\ 
ppm for bystanders. The exposure estimates for material substitution 
plus local exhaust ventilation ranged from 2.5 x 10-\2\ ppm 
to 4.7 x 10-\1\ ppm for workers and 2.1 x 10-\2\ 
ppm to 4.0 x 10-\1\ ppm for bystanders. All exposure level 
estimates for the various scenarios considered are available in the TCE 
risk assessment (Ref. 1) and Supplemental Occupational Exposure and 
Risk Reduction Technical Report in Support of Risk Management Options 
for Trichloroethylene (TCE) Use in Spot Cleaning (Ref. 25).
    The results indicate that alternate regulatory options such as 
reducing the concentration of TCE in spot cleaners for dry cleaning 
facilities and using local exhaust ventilation to improve ventilation 
near worker activity could not achieve the target MOE benchmarks for 
non-cancer endpoints for acute and chronic exposures and standard 
cancer risk benchmarks for chronic exposures. The results also 
demonstrate that all risk reduction options require the use of a 
respirator, whether used alone or in conjunction with additional levels 
of protection, in order to meet the non-cancer and cancer risk 
benchmarks (Ref. 25). Therefore, EPA found that options setting a 
maximum concentration in products under section 6(a)(2) did not address 
the identified unreasonable risks because the options failed--by orders 
of magnitude--to meet the risk benchmarks. Options found not to meet 
the risk benchmarks and which, therefore, do not address the identified 
unreasonable risks are documented in EPA's supplemental technical 
report on spot cleaning (Ref. 25).
    3. Assessment of regulatory options to determine whether they 
address the identified unreasonable risks to the extent necessary so 
that TCE no longer presents such risks. As discussed in Unit V., EPA 
considered a number of regulatory options under section 6(a) to address 
TCE risks from spot cleaning in dry cleaning facilities which are 
reflected in EPA's supporting analysis (Ref. 29). In assessing these 
options, EPA considered a wide range of exposure scenarios (Ref. 25). 
These include both baseline and risk reduction scenarios involving 
varying factors such as reduction of TCE content in spot cleaners, 
exposure concentration percentiles, local exhaust ventilation use, 
respirator use, working lifetimes, etc. The options that could reduce 
the risks of TCE use to the benchmark MOE and standard cancer 
benchmarks for spot cleaning in dry cleaning include (a) prohibiting 
the manufacture, processing, and distribution in commerce of TCE for 
use as a spot cleaner in dry cleaning facilities (section 6(a)(2)) plus 
prohibiting the use of TCE as a spot cleaner in dry cleaning facilities 
(section 6(a)(5)) and requiring downstream notification when 
distributing TCE for other uses under section 6(a)(3); (b) variations 
on such a supply-chain approach (such as just prohibiting the 
manufacture, processing, distribution in commerce of TCE for use as a 
spot cleaner in dry cleaning facilities under section 6(a)(2) or just 
prohibiting the commercial use of TCE as a spot cleaner in dry cleaning 
facilities under section 6(a)(5)); (c) requiring the use of personal 
protective equipment in dry cleaning facilities in which TCE is used as 
a spot cleaner under section 6(a)(5) or requiring the use of personal 
protective equipment and engineering controls in dry cleaning 
facilities in which TCE is used as a spotting agent under section 
6(a)(5).
    The full range of regulatory options considered under section 6(a) 
is reflected in EPA's supporting analysis (Ref. 29). A discussion of 
the regulatory options that were determined to have the potential to 
address the identified unreasonable risks is provided in this Unit, 
along with the Agency's evaluation of how well those regulatory options 
would address the unreasonable risks in practice.
    a. Proposed approach to prohibit manufacturing, processing, 
distribution in commerce, and use of TCE for spot cleaning in dry 
cleaning facilities and require downstream notification. As noted 
previously, the proposed regulatory approach uses several elements of 
TSCA section 6(a) to address the risk of TCE use for spot cleaning in 
dry cleaning facilities throughout the supply chain. The proposed 
regulatory approach would prohibit the manufacturing, processing, and 
distribution in commerce of TCE for spot cleaning in dry cleaning 
facilities under TSCA Sec.  6(a)(2), prohibit the commercial use of TCE 
for spot cleaning in dry cleaning facilities under TSCA Sec.  6(a)(5), 
and require manufacturers, processors, and distributors, except for 
retailers, to provide downstream notification, e.g., via a SDS, of the 
prohibitions under TSCA Sec.  6(a)(3).
    As discussed in Unit VII.B.1, the MOEs for occupational exposure 
for spot cleaning in dry cleaning facilities are below the non-cancer 
MOE benchmarks for all non-cancer effects (e.g., developmental effects, 
kidney toxicity, and immunotoxicity) and standard cancer benchmarks. 
Under this proposed approach, exposures to TCE from this use would be 
completely eliminated. As a result, both non-cancer and cancer risks 
from exposure to TCE from this use would be eliminated (Ref. 39). All 
employees in dry cleaning facilities would benefit; and Asian and 
Hispanic populations, which are over-represented in dry cleaning 
facilities, would disproportionally benefit from the proposed approach.
    The proposed approach would ensure that workers and occupational 
bystanders are no longer at risk from TCE exposure associated with this 
use throughout the supply chain. By proposing to prohibit the 
manufacture, processing and distribution in commerce of TCE for use as 
a spot cleaner in dry cleaning facilities, EPA would ensure that 
manufacturers, processors and distributors would not sell TCE for a use 
that EPA has determined presents an unreasonable risk of injury to 
health, and the intentional or unintentional availability of TCE for 
spot cleaning in dry cleaning facilities would be minimized. The 
proposal to prohibit commercial use of TCE as a spot cleaner in dry 
cleaning facilities would eliminate commercial demand for TCE-based 
spot cleaning products and would more effectively protect workers and 
bystanders than a prohibition only on manufacture, processing or 
distribution for this use under Section 6(a)(2). The prohibition on 
commercial use ensures that commercial users would not be able to 
divert TCE manufactured for other

[[Page 91610]]

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

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

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

[[Page 91611]]

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

D. Summary

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

VIII. Other Factors Considered

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

[[Page 91612]]

disorder, non-Hodgkin's lymphoma, endocrine and reproductive effects 
(e.g., decreased libido and potency), neurotoxicity (e.g., trigeminal 
neuralgia), and toxicity to the liver (impaired functioning and liver 
cancer) (Ref. 1). TCE may cause fetal cardiac malformations that begin 
in utero. In addition, fetal death, possibly resulting from cardiac 
malformation, can be caused by exposure to TCE. Cardiac malformations 
can be irreversible and impact a person's health for a lifetime. Other 
effects, such as damage to the developing immune system, may first 
manifest when a person is an adult and can have long-lasting health 
impacts. Certain effects that follow adult exposures, such as kidney 
and liver cancer, may develop many years after initial exposure. The 
point during a lifetime when the effect manifests itself and the 
expected impacts to a person during her/his lifetime are important 
factors in determining the benefits of mitigating and preventing TCE 
exposure.
    Based on EPA's analysis of worker and consumer populations' 
exposure to TCE, EPA has determined that there are significant cancer 
and non-cancer risks (acute and chronic) from TCE exposure, which can 
result in developmental effects, kidney toxicity, immunotoxicity, 
reproductive toxicity, neurotoxicity, and liver toxicity. These risks 
are unreasonable risks because the chemical exposures predicted for the 
various scenarios assessed are above what would be necessary to achieve 
the MOE benchmarks for cardiac defects, kidney toxicity, 
immunotoxicity, liver toxicity, neurotoxicity and endocrine and 
reproductive toxicity. For commercial use scenarios of aerosol 
degreasing and use of TCE for spot cleaning in dry cleaning facilities, 
as well as for all the residential use scenarios, exposures are far 
beyond what would be necessary to achieve the MOE benchmark for cardiac 
defects. For example, the 99th percentile of the upper end exposure use 
scenario for aerosol degreasing has a MOE of 0.003 for chronic 
exposures and 0.002 for acute exposures. Thus, for this aerosol 
degreasing use scenario, people are exposed at a level that is 3,000 
times higher than what EPA determines is protective for the non-cancer 
health effect.
    The number of people at risk for the developmental effects is 
estimated to be up to approximately 5,400 pregnant women in dry 
cleaning operations and approximately 900 pregnant women exposed to TCE 
during the use of aerosol degreasers. The potential for exposure is 
significant because approximately half of all pregnancies are 
unintended. If a pregnancy is not planned before conception, a woman 
may not be in optimal health for childbearing (Ref. 33).
    Given the large differential between the benchmark MOE and the MOEs 
resulting from EPA's estimates of exposures, people exposed to TCE in 
aerosol degreasing and during dry cleaning operations are at 
significant risk for the multiple adverse non-cancer health effects 
caused by TCE and the impacts discussed below on many facets of their 
life that these adverse health effects cause. These risks are 
significant even when considered alone. However, workers may be also be 
impacted by the significant risks for several types of cancer. The 
cancer risks to workers using TCE in aerosol degreasing and for spot 
cleaning in dry cleaning facilities are 1.6 x 10-2 or more 
than one and one-half cases in one hundred for aerosol degreasing and 
1.4 x 10-2 or more than one case in one hundred for use of 
TCE for spot cleaning in dry cleaning facilities.
    The risk reduction from preventing TCE exposure cannot be 
comprehensively quantified or monetized even though the adverse effects 
are well-documented, the TCE risk assessment estimating these risks has 
been peer-reviewed, and the benefits of reducing the risk of these 
health endpoints can be described. It is relatively straightforward to 
monetize the benefits of reducing the risk of cancer (kidney cancer, 
liver cancer, non-Hodgkin's lymphoma) due to TCE exposure. The 
estimated value of the annualized benefit is estimated to be $9.3 
million to $25.0 million at 3% and $4.5 million to $12.8 million at 7% 
over 15 years. It is currently not possible to monetize the benefits of 
reducing the risks of the costs of non-cancer effects (all 
developmental toxicity, kidney toxicity, immunotoxicity, reproductive 
toxicity, neurotoxicity, and liver toxicity) of TCE exposure. There are 
two reasons for this. First, dose response information and 
concentration response functions in humans are not available, which 
would allow EPA to estimate the number of population-level non-cancer 
cases that would be avoided by reducing exposures to levels 
corresponding with MOE benchmarks. Second, even it were possible to 
calculate the number of cases avoided, EPA may not be able to monetize 
the benefits of these avoided cases due to limitations in data needed 
to apply established economic methodologies. However, being unable to 
quantitatively assess individual risk and population-level non-cancer 
cases avoided from TCE exposure does not negate the impact of these 
effects. Similarly, the inability to monetize an adverse effect does 
not reflect the severity of the effect, the lifetime nature of the 
impact, or the magnitude of the benefit in preventing the adverse 
impact from TCE exposure, such as a cardiac malformation, on a person. 
In considering the benefits of preventing TCE exposure, EPA considered 
the type of effect, the severity of the effect, the duration of the 
effect, and costs and other monetary impacts of the health endpoint.
    The health endpoints associated with TCE exposure are serious. The 
following is a discussion of the impacts of the most significant cancer 
and non-cancer effects associated with TCE exposure, including the 
severity of the effect, the manifestation of the effect, and how the 
effect impacts a person during their lifetime. While TCE can cause a 
variety of adverse health effects, the general population incidences of 
these adverse health outcomes are not due solely to TCE.

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

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

[[Page 91613]]

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

[[Page 91614]]

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

[[Page 91615]]

    Treatment for NHL will result in substantial costs for hospital and 
doctors' visits in order to treat the cancer. The treatments for NHL 
can also have countervailing risks and can lead to higher 
susceptibility of patients for secondary malignancies (Ref. 55). The 
emotional and mental toll from wondering whether a treatment will be 
successful, going through the actual treatment, and inability to do 
normal activities or work will most likely be high. This emotional and 
mental toll will extend to the person's family and friends as they 
struggle with the diagnosis and success and failure of a treatment 
regime. If a person has children, this could affect their mental and 
emotional well-being and may impact their success in school. A 
discussion of the monetized benefits associated with reducing risk of 
NHL is located in Unit VIII.B. The estimated value of the annualized 
benefit is $759,000 to $1.2 million for aerosol degreasing and $3.9 
million to $10.1 million for spot cleaning in dry cleaning facilities 
at 3% over 15 years; and $355,000 to $601,000 for aerosol degreasing 
and $1.8 million to $5.0 million for spot cleaning in dry cleaning 
facilities at 7% over 15 years.
    4. Reproductive and endocrine effects. The TCE risk assessment 
identified chronic non-cancer risks for reproductive effects for 
workers and bystanders exposed to TCE. There are increased health risks 
for reproductive effects for the approximately 10,800 workers and 
occupational bystanders at commercial aerosol degreasing operations and 
the up to approximately 168,000 workers and occupational bystanders in 
dry cleaning operations (Ref. 2).
    The reproductive effect for both females and males can be altered 
libido. The prevalence of infertility is estimated at about 10-15% of 
couples with a decreased libido among the factors of infertility (Ref. 
56). For females, there can be reduced incidence of fecundability (6.7 
million women ages 15 to 44 or 10.9% affected) (Ref. 57), increase in 
abnormal menstrual cycle, and amenorrhea (the absence of menstruation). 
Reproductive effects on males can be decreased potency, gynaecomastia, 
impotence, and decreased testosterone levels, or low T levels. 
Approximately 2.4 million men age 40 to 49 have low T levels, with a 
new diagnosis of about 481,000 androgen deficiency cases a year. Other 
estimates propose a hypogonadism prevalence of about 13 million 
American men (Ref. 58). Low T levels are associated with aging; an 
estimated 39% of men 45 or older have hypogonadism, resulting in low T 
levels (Ref. 59). Hormone therapy and endocrine monitoring may be 
required in the most severe cases. Low T levels are associated with 
aging; an estimated 39% of men 45 or older have hypogonadism, resulting 
in low T levels (Ref. 59). Hormone therapy and endocrine monitoring may 
be required in the most severe cases.
    The monetary costs of these potential reproductive effects involve 
doctor's visits in order to try to determine why there is a change. In 
some instances, a person or couple may need to visit a fertility 
doctor.
    The impact of a reduced sex drive can take an emotional and mental 
toll on single people as well as couples. For people trying to get 
pregnant, decreased fertility can add stress to a relationship as the 
cause is determined and avenues explored to try to resolve the 
difficulties in conceiving. A person or couples' quality of life can 
also be affected as they struggle with a reduced sex drive. Similar to 
effects discussed previously, while neither the precise reduction in 
individual risk of developing this disorder from reducing TCE exposure 
or the total number of cases avoided can be estimated, the Agency still 
considers their impact.
    5. Neurotoxicity. The TCE risk assessment identified chronic risks 
for neurotoxicity for workers and bystanders. There are increased 
health risks for neurotoxicity to the approximately 10,800 workers and 
bystanders at commercial aerosol degreasing operations and the up to 
approximately 168,000 workers and bystanders in dry cleaning operations 
(Ref. 2).
    Studies have also demonstrated neurotoxicity for acute exposure. 
Neurotoxic effects observed are alterations in trigeminal nerve and 
vestibular function, auditory effects, changes in vision, alterations 
in cognitive function, changes in psychomotor effects, and 
neurodevelopmental outcomes. Developmental neurotoxicity effects are 
delayed newborn reflexes, impaired learning or memory, aggressive 
behavior, hearing impairment, speech impairment, encephalopathy, 
impaired executive and motor function and attention deficit (Ref. 3).
    The impacts of neurotoxic effects due to TCE exposure can last a 
person's entire lifetime. Changes in vision may impact a person's 
ability to drive, which can create difficulties for daily life. 
Impaired learning or memory, aggressive behavior, hearing impairment, 
speech impairment, encephalopathy, impaired executive and motor 
function and attention deficit can impact a child's educational 
progression and adolescent's schooling and ability to make friends, 
which in turn can impact the type of work or ability get work later in 
life.
    Neurotoxicity in adults can affect the trigeminal nerve, the 
largest and most complex of the 12 cranial nerves, which supplies 
sensations to the face, mucous membranes, and other structures of the 
head. Onset of trigeminal neuralgia generally occurs in mid-life and 
known causes include multiple sclerosis, sarcoidosis and Lyme disease. 
There is also a co-morbidity with scleroderma and systemic lupus. Some 
data show that the prevalence of trigeminal neuralgia could be between 
0.01% and 0.3% (Ref. 60). Alterations to this nerve function might 
cause sporadic and sudden burning or shock-like facial pain to a 
person. One way to relieve the burning or shock-like facial pain is to 
undergo a procedure where the nerve fibers are damaged in order to 
block the pain. This treatment can have lasting impact on sensation 
which may also be deleterious for normal pain sensation. The potential 
side effects of this procedure includes facial numbness and some 
sensory loss.
    The monetary health costs can range from doctor's visits and 
medication to surgeries and hospital stays. Depending upon when the 
neurotoxic effect occurred, the monetary costs may encompass a person's 
entire lifetime or just a portion.
    The personal costs (emotional, mental, and impacts to a person's 
quality of life) cannot be discounted. Parents of a child with impaired 
learning, memory, or some other developmental neurotoxic effect may 
suffer emotional and mental stress related to worries about the child's 
performance in school, ability to make friends, and quality of the 
child's life because early disabilities can have compounding effects as 
they grow into adulthood. The parent may need to take off work 
unexpectedly and have the additional cost of doctor visits and/or 
medication.
    For a person whose trigeminal nerve is affected there is an 
emotional and mental toll as they wonder what is wrong and visit 
doctors in order to determine what is wrong. Depending on the severity 
of the impact to the nerve they may be unable to work. Doctor visits 
and any inability to work will have a monetary impact to the person. 
There are varying costs (emotional, monetary, and impacts to a person's 
quality of life) from the neurotoxicity effects due to TCE exposure. 
However, while neither the precise reduction in

[[Page 91616]]

individual risk of developing this disorder from reducing TCE exposure 
or the total number of cases avoided can be estimated, this is not a 
reason to disregard their impact.
    6. Liver toxicity. The TCE risk assessment identified liver 
toxicity as an adverse effect of chronic TCE exposure. There are 
increased health risks for liver toxicity to the approximately 10,800 
workers occupational bystanders at commercial aerosol degreasing 
operations and the up to approximately 168,000 workers and occupational 
bystanders in dry cleaning operations (Ref. 1).
    Specific effects to the liver can include increased liver weight, 
increase in DNA synthesis (transient), enlarged hepatocytes, enlarged 
nuclei, and peroxisome proliferation (Ref. 1). In addition, workers 
exposed to TCE have shown hepatitis accompanying immune-related 
generalized skin diseases, jaundice, hepatomegaly, hepatosplenomegaly, 
and liver failure (Ref. 1).
    Some form of liver disease impacts at least 30 million people, or 1 
in 10 Americans (Ref. 61). Included in this number is at least 20% of 
those with nonalcoholic fatty liver disease (NAFLD) (Ref. 61). NAFLD 
tends to impact people who are overweight/obese or have diabetes. 
However, an estimated 25% do not have any risk factors (Ref. 61). The 
danger of NAFLD is that it can cause the liver to swell, which may 
result in cirrhosis over time and could even lead to liver cancer or 
failure (Ref. 61). The most common known causes to this disease burden 
are attributable to alcoholism and viral infections, such as hepatitis 
A, B, and C. In 2013, there were 1,781 reported acute cases of viral 
hepatitis A and the estimated actual cases were 3,500 (Ref. 62). For 
hepatitis B in 2013 there were 3,050 reported acute cases, while the 
estimated actual incidence was 19,800, and the estimated chronic cases 
in the United States is between 700,000 to 1.4 million (Ref. 62). For 
hepatitis C, in 2013 there were 2,138 reported cases; however, the 
estimated incidence was 29,700 and the estimated number of chronic 
cases is between 2.7 to 3.9 million (Ref. 62). These known 
environmental risk factors of hepatitis infection may result in 
increased susceptibility of individuals exposed to organic chemicals.
    Effects from TCE exposure to the liver can occur quickly. Liver 
weight increase has occurred in mice after as little as 2 days of 
inhalation exposure (Ref. 3). Human case reports from eight countries 
indicated symptoms of hepatitis, hepatomegaly and elevated liver 
function enzymes, and in rare cases, acute liver failure developed 
within as little as 2-5 weeks of initial exposure to TCE (Ref. 3).
    Chronic exposure to TCE can also lead to liver cancer. There is 
strong epidemiological data that reported an association between TCE 
exposure and the onset of various cancers, including liver cancer. The 
estimated value of the annualized benefit is $493,000 to $811,000 for 
aerosol degreasing and $2.5 million to $6.7 million for spot cleaning 
in dry cleaning facilities at 3% over 15 years; and $252,000 to 
$436,000 for aerosol degreasing and $1.3 million to $3.6 million for 
spot cleaning in dry cleaning facilities at 7% over 15 years.
    Additional medical and emotional costs are associated with non-
cancer liver toxicity from TCE exposure, although they cannot be 
quantified. These costs include doctor and hospital visits and 
medication costs. In some cases, the ability to work can be affected, 
which in turn impacts the ability to get proper ongoing medical care. 
Liver toxicity can lead to jaundice, weakness, fatigue, weight loss, 
nausea, vomiting, abdominal pain, impaired metabolism, and liver 
disease. Symptoms of jaundice include yellow or itchy skin and a 
yellowing of the whites of the eye, and a pale stool and dark urine. 
These symptoms can create a heightened emotional state as a person 
tries to determine what is wrong with them.
    Depending upon the severity of the jaundice, treatments can range 
significantly. Simple treatment may involve avoiding exposure to the 
TCE; however, this may impact a person's ability to continue to work. 
In severe cases, the liver toxicity can lead to liver failure, which 
can result in the need for a liver transplant, if a donor is available. 
Liver transplantation is expensive (with an estimated cost of $575,000) 
and there are countervailing risks for this type of treatment (Ref. 
63). The mental and emotional toll on an individual and their family as 
they try to determine the cause of sickness and possibly experience an 
inability to work, as well as the potential monetary cost of medical 
treatment required to regain health are significant.
    7. Disproportionate impacts on environmental justice communities. 
An additional factor that cannot be monetized is the disproportionate 
impact on environmental justice communities. Asian and Hispanic 
populations are disproportionately represented in dry cleaning 
facilities. 13% of dry cleaning workers are Asian, compared to 5% of 
the national population, and 30% of dry cleaning workers are Hispanic 
(of any race), compared to 16% of the national population, indicating 
that these two populations are over-represented. Because they are 
disproportionately over-represented in the dry cleaning industry, these 
populations are disproportionately exposed to TCE during spot cleaning 
in dry cleaning facilities and disproportionately at risk to the range 
of adverse non-cancer effects and cancer.

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

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

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

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

[[Page 91617]]

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

D. Comparison of Benefits and Costs

    The monetized benefits for preventing the risks resulting from TCE 
exposure from both these uses significantly outweigh the estimated 
costs. Even though simply comparing the costs and monetized benefits of 
prohibiting the manufacture, processing, and distribution in commerce 
of TCE as an aerosol degreaser; prohibiting its use as an aerosol 
degreaser; and requiring downstream notification demonstrates that the 
monetized benefits of this proposed action outweigh the costs, EPA 
believes that the balance of costs and benefits cannot be fairly 
described without considering the additional, non-monetized benefits of 
mitigating the non-cancer adverse effects as well as cancer. As 
discussed previously, the multitude of potential adverse effects 
associated with TCE exposure can profoundly impact an individual's 
quality of life. Some of the adverse effects associated with TCE 
exposure can be immediately experienced and can affect a person from 
childhood throughout a lifetime (e.g., cardiac malformations, 
developmental neurotoxicity, and developmental immunotoxicity). Others 
(e.g., adult immunotoxicity, kidney and liver failure or cancers) can 
have impacts that are experienced for a shorter portion of life, but 
are nevertheless significant in nature.
    While the risk of non-cancer health effects associated with TCE 
exposure cannot be quantitatively estimated, the qualitative discussion 
highlights how some of these non-cancer effects occurring much earlier 
in life from TCE exposure may be as severe as cancer's mortality and 
morbidity and thus just as life-altering. These effects include not 
only medical costs but also personal costs such as emotional and mental 
stress that are impossible to accurately measure.
    While the impacts of non-cancer effects cannot be monetized, EPA 
considered the impacts of these effects in making its determination 
about how best to address the unreasonable risks presented by TCE use 
in aerosol degreasing and as a spot cleaner in dry cleaning facilities. 
Considering only monetized benefits would significantly underestimate 
the impacts of TCE-induced non-cancer adverse outcomes on a person's 
quality of life to perform basic skills of daily living, including the 
ability to earn a living, the ability to participate in sports and 
other activities, and the impacts on a person's family and 
relationships.
    Thus, considering costs, benefits that can be monetized (risk of 
cancer), and benefits that cannot be quantified and subsequently 
monetized (risk of developmental toxicity, kidney toxicity, 
immunotoxicity, reproductive toxicity, neurotoxicity, and liver 
toxicity), including benefits related to the severity of the effects 
and the impacts on a person throughout her/his lifetime in terms of 
medical costs, effects on earning power and personal costs, emotional 
and psychological costs, and the disproportionate impacts on Asian and 
Hispanic communities, the benefits of preventing TCE exposure outweigh 
the costs. Further, if EPA were to consider only the benefits that can 
be monetized in comparison to the cost, the monetized benefits from 
preventing kidney and liver cancer and non-Hodgkin's lymphoma from the 
use of TCE in aerosol degreasing (the annualized monetized benefits on 
a 15 year basis range from approximately $1.5 million to $2.7 million 
at 3% and $700,000 to $1.4 million at 7%) and the use of TCE in spot 
cleaners in dry cleaning facilities (the annualized monetized benefits 
on a 15 year basis range from approximately $7.8 million to $22.3 
million at 7% and $3.7 million to $11.4 million at 3%) far outweigh the 
costs of the proposed approaches for use of TCE in aerosol degreasing 
(the annualized costs on a 15 year basis range from approximately 
$37,000 to $40,000 at 3% and $46,000 to $49,000 at 7%) and for use of 
TCE in spot cleaners in dry cleaning facilities (the annualized costs 
on a 15 year basis range from approximately $130,000 to $133,000 at 3% 
and $135,000 to $137,000 at 7%).

IX. Overview of Uncertainties

    A discussion of the uncertainties associated with this proposed 
rule can be found in the TCE risk assessment (Ref. 1) and in the 
supplemental analysis (Refs. 23, 24, 25) for use of TCE in aerosol 
degreasing and use of TCE for spot cleaning in dry cleaning facilities. 
A summary of these uncertainties follows.
    EPA used a number of assumptions in the TCE risk assessment and 
supporting analysis to develop estimates for occupational and consumer 
exposure scenarios and to develop the hazard/dose[hyphen]response and 
risk characterization. EPA recognizes that the uncertainties may 
underestimate or overestimate actual risks. These uncertainties 
include: (1) Releases of and exposures to

[[Page 91618]]

TCE can vary from one aerosol degreasing activity to the next. EPA 
attempted to quantify this uncertainty by evaluating multiple scenarios 
to establish a range of releases and exposures. In estimating the risk 
from aerosol degreasing, there are uncertainties in the number of 
workers exposed to TCE and in the inputs to the models used to estimate 
exposures. (2) Although EPA found information about TCE products 
intended for consumer use, there is some general uncertainty regarding 
the nature and extent of the consumer use of aerosol products 
containing TCE. (3) Releases of and exposures to TCE can vary from one 
dry cleaning facility to the next. EPA attempted to quantify this 
uncertainty by evaluating multiple scenarios to establish a range of 
releases and exposures. There is also uncertainty in the number of 
workers exposed to TCE for spot cleaning in dry cleaning facilities. 
There are uncertainties in the model and inputs used to model the 
exposures to TCE from these uses.
    In addition to the uncertainties in the risks, there are 
uncertainties in the cost and benefits. The uncertainties in the 
benefits are most pronounced in estimating the benefits from preventing 
the non-cancer adverse effects because these benefits generally cannot 
be monetized due to the lack of concentration response functions in 
humans leading to the ability to estimate the number of population-
level non-cancer cases and limitations in established economic 
methodologies. Additional uncertainties in benefit calculations include 
the reliance on professional judgment to estimate the alternatives that 
users might choose to adopt and the potential risks for adverse health 
effects that the alternatives may pose. While there are some products 
that have comparable risks, there are a number of alternatives that are 
likely to be of lower risk, although EPA is unable to estimate the 
incremental change in the risk. To account for this uncertainty, EPA 
includes a lower and a higher estimate for the benefits from 
eliminating exposure to TCE. The lower benefits estimate does not 
include any benefits for firms that switch to anything other than 
water-based, methyl ester (soy-based) cleaners, or acetone degreasers. 
The higher benefits estimate includes the benefit from entirely 
eliminating TCE exposure for all alternative compliance strategies and 
assumes that no risks are introduced by alternatives. This inability to 
adequately account for adverse health effects of alternatives in the 
benefits analysis is expected to contribute most to the uncertainty in 
the estimates.
    There are also uncertainties in the estimates of the number of 
affected facilities, particularly those for the aerosol degreasing use 
and for numbers of processors and distributors of TCE-containing 
products not prohibited by the proposed rule who are required to 
provide downstream notification and/or maintain records. The estimate 
for number of facilities using TCE-containing aerosol degreasers is 
based on EPA calculations using data derived from the California Air 
Resources Board Initial Statement of Reasons for the Proposed Airborne 
Toxic Control Measure for Emissions of Chlorinated Toxic Air 
Contaminants from Automotive Maintenance and Repair Activities (Ref. 
2). To estimate the number of processors, EPA relied on public 2012 CDR 
data. The number of sites is reported in the CDR data as a range. The 
midpoint of the reported ranges was used to estimate the total number 
of sites using the chemical. Furthermore, the CDR data only include 
processors immediately downstream of those reporting to CDR. Finally, 
EPA estimated the number of wholesaler firms distributing products 
containing TCE by taking a ratio of the number of Chemical and Allied 
Products Merchant Wholesaler firms to Basic Chemical Manufacturing 
firms and applying it to the estimated number of manufacturers and 
processors of TCE (Ref. 2).
    Another uncertainty concerns the estimate for the cost of 
reblending products and the time required to reblend those products. 
EPA used a study on the automotive aftermarket parts products industry 
that provided a range of costs for product reformulation and used the 
mean value of $26,000 from that study. EPA contacted both dry cleaners 
and blenders of aerosol degreasing products for additional information 
and received a few estimates from the aerosol degreasing product 
blenders which ranged from $15,000 to $30,000. However, EPA received no 
information from dry cleaning spot cleaning product blenders, so there 
is some uncertainty as to how representative the estimate is for that 
industry.
    EPA also assumes that companies are generally able to reblend 
products within 6 months following publication of the final rule; 
however, it is not certain whether they may experience additional costs 
if they are not able have a product available to market at that time.
    EPA will consider additional information received during the public 
comment period, including comments on implementation timeframes. This 
includes public comments, scientific publications, and other input 
submitted to EPA during the comment period.

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

A. Section 9 Analysis

    1. Section 9(a) analysis. Section 9(a) of TSCA provides that, if 
the Administrator determines in her discretion that unreasonable risks 
may be prevented or reduced to a sufficient extent by action taken 
under a Federal law not administered by EPA, the Administrator must 
submit a report to the agency administering that other law that 
describes the risk and the activities that present such risk. If the 
other agency responds by declaring that the activities described do not 
present unreasonable risks or if that agency initiates action under its 
own law to protect against the risk, EPA is precluded from acting 
against the risk under sections 6 or 7 of TSCA.
    Section 9(d) of TSCA instructs the Administrator to consult and 
coordinate TSCA activities with other Federal agencies for the purpose 
of achieving the maximum enforcement of TSCA while imposing the least 
burden of duplicative requirements. For today's proposed rule, EPA has 
consulted with CPSC and OSHA.
    CPSC protects the public from unreasonable risks of injury or death 
associated with the use of consumer products under the agency's 
jurisdiction. There are no CPSC regulations on use of TCE in aerosol 
degreasers and for spot cleaning at dry cleaning facilities (Ref. 64).
    OSHA assures safe and healthful working conditions for working men 
and women by setting and enforcing standards and by providing training, 
outreach, education and assistance. OSHA adopted an eight-hour time 
weighted average PEL of 100 ppm along with a ceiling limit in 1971 
shortly after the agency was formed. It was based on the American 
Conference of Governmental Industrial Hygienists (ACGIH) recommended 
occupational exposure limit that was in place at that time. OSHA 
recognizes that the TCE PEL and many other PELs issued shortly after 
adoption of the OSHA Act in 1970 are outdated and inadequate for 
ensuring protection of worker health. OSHA recently published a Request 
for Information on approaches to updating PELs and other strategies to 
managing chemicals in the workplace (Ref. 9).

[[Page 91619]]

OSHA's current regulatory agenda does not include revision to the TCE 
PEL or other regulations addressing the risks EPA has identified when 
TCE is used in aerosol degreasing or for spot cleaning in dry cleaning 
facilities (Ref. 9).
    EPA has determined that risks from the use of TCE in aerosol spray 
degreasers and as a spot cleaner in dry cleaning facilities are best 
managed by regulation under TSCA rather than by referral to other 
agencies. Today's proposed rule addresses risk from TCE exposure to 
populations in both workplaces and consumer settings. With the 
exception of TSCA, there is no Federal law that provides authority to 
prevent or sufficiently reduce these cross-cutting exposures. No other 
Federal regulatory authority, when considering the exposures to the 
populations and within the situations in its purview, can evaluate and 
address the totality of the risk that EPA is addressing in this 
proposed rulemaking under TSCA. For example, OSHA may set exposure 
limits for workers but its authority is limited to the workplace and 
does not extend to consumer uses of hazardous chemicals. Further, OSHA 
does not have direct authority over state and local employees, and it 
has no authority at all over the working conditions of state and local 
employees in states that have no OSHA-approved State Plan under 29 
U.S.C. 667. Other Federal regulatory authorities, such as CPSC, have 
the authority to only regulate pieces of the TCE risk, such as consumer 
products. And neither agency has authority to bar the manufacture, 
processing or distribution for these uses and require downstream 
notification of restrictions like EPA proposes to do.
    Moreover, recent amendments to TSCA, Public Law 114-182, alter both 
the manner of identifying unreasonable risk under TSCA and EPA's 
authority to address unreasonable risk under TSCA, such that risk 
management under TSCA is increasingly distinct from analogous 
provisions of the Consumer Product Safety Act (CPSA), the Federal 
Hazardous Substances Act (FHSA), or the OSH Act. These changes to TSCA 
reduce the likelihood that an action under the CPSA, FHSA, or the OSH 
Act would reduce the risk of these uses of TCE so that the risks are no 
longer unreasonable under TSCA. Whereas (in a TSCA section 6 rule) an 
unreasonable risk determination sets the objective of the rule in a 
manner that excludes cost considerations, 15 U.S.C. 2605(b)(4)(A), 
subject to time-limited conditional exemptions for critical chemical 
uses and the like, 15 U.S.C. 2605(g), a consumer product safety rule 
under the CPSA must include a finding that ``the benefits expected from 
the rule bear a reasonable relationship to its costs.'' 15 U.S.C. 
2058(f)(3)(E). Additionally, recent amendments to TSCA reflect 
Congressional intent to ``delete the paralyzing `least burdensome' 
requirement,'' 162 Cong. Rec. S3517 (June 7, 2016). However, a consumer 
product safety rule under the CPSA must impose ``the least burdensome 
requirement which prevents or adequately reduces the risk of injury for 
which the rule is being promulgated.'' 15 U.S.C. 2058(f)(3)(F). 
Analogous requirements, also at variance with recent revisions to TSCA, 
affect the availability of action under the FHSA relative to action 
under TSCA. 15 U.S.C. 1262. Gaps also exist between OSHA's authority to 
set workplace standards under the OSH Act and EPA's amended obligations 
to sufficiently address chemical risks under TSCA. To set PELs for 
chemical exposure, OSHA must first establish that the new standards are 
economically feasible and technologically feasible. (79 FR 61387, 
October 10, 2014). But under TSCA, EPA's substantive burden under TSCA 
section 6(a) is to demonstrate that, as regulated, the chemical 
substance no longer presents an unreasonable risk, with unreasonable 
risk being determined without consideration of cost or other non-risk 
factors.
    TSCA is the only regulatory authority able to prevent or reduce 
risk from these uses of TCE to a sufficient extent across the range of 
uses and exposures of concern. In addition, these risks can be 
addressed in a more coordinated, efficient and effective manner under 
TSCA than under two or more different laws implemented by different 
agencies. Accordingly, EPA determines that referral to other Federal 
authorities for risk management would not necessarily address the 
unreasonable risk. As noted previously, there are key differences 
between the newly amended finding requirements of TSCA and those of the 
OSH Act, CPSA, and the FHSA. For these reasons, in her discretion, the 
Administrator does not determine that unreasonable risks from these 
uses of TCE may be prevented or reduced to a sufficient extent by an 
action taken under a Federal law not administered by EPA.
    2. Section 9(b) analysis. If EPA determines that actions under 
other Federal authorities administered in whole or in part by EPA may 
eliminate or sufficiently reduce unreasonable risks, section 9(b) of 
TSCA instructs EPA to use these other statutes unless the Administrator 
determines in the Administrator's discretion that it is in the public 
interest to protect against such risk under TSCA. In making such a 
public interest determination, section 9(b)(2) of TSCA states: ``the 
Administrator shall consider, based on information reasonably available 
to the Administrator, all relevant aspects of the risk . . . and a 
comparison of the estimated costs and efficiencies of the action to be 
taken under this title and an action to be taken under such other law 
to protect against such risk.''
    Although several EPA statutes have been used to limit TCE exposure, 
as discussed in Unit III.A, regulations under these EPA statutes have 
limitations because they largely regulate releases to the environment, 
rather than direct human exposure. SDWA only applies to drinking water. 
CAA does not apply directly to worker exposures or consumer settings 
where TCE is used. Under RCRA, TCE that is discarded may be considered 
a hazardous waste and subject to requirements designed to reduce 
exposure from the disposal of TCE to air, land and water. RCRA does not 
address exposures during use of products containing TCE. Only TSCA 
provides EPA the authority to regulate the manufacture (including 
import), processing, and distribution in commerce, and use of chemicals 
substances.

B. Section 26(h) Considerations

    In proposing this rule under section 6 of TSCA, the EPA has made a 
decision based on science. EPA has used scientific information, 
technical procedures, measures, methods, protocols, methodologies, and 
models consistent with the best available science. Specifically, EPA 
based its preliminary determination of unreasonable risk presented by 
the use of TCE in aerosol degreasing products and as a spot cleaner in 
dry cleaning facilities on the completed risk assessment, which 
followed a peer review and public comment process, as well as using 
best available science and methods (Ref. 1). Additional information on 
the peer review and public comment process, such as the peer review 
plan, the peer review report, and the Agency's response to comments, 
can be found on EPA's Assessments for TSCA Work Plan Chemicals Web page 
at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/assessments-tsca-work-plan-chemicals.
    The scientific information and technical measures and models used 
in the risk assessment and supplemental analyses are consistent with 
the intended use for risk reduction by regulation under section 6 of 
TSCA. The degree of clarity and completeness of

[[Page 91620]]

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

XI. Major Provisions of the Proposed Rule

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

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

B. Downstream Notification

    EPA has authority under section 6 of TSCA to require that a 
substance or mixture or any article containing such substance or 
mixture be marked with or accompanied by clear and adequate minimum 
warnings and instructions with respect to its use, distribution in 
commerce, or disposal or with respect to any combination of such 
activities. Many TCE manufacturers and processors are likely to 
manufacture or process TCE or TCE containing products for other uses 
that would not be regulated under this proposed rule. Other companies 
may be strictly engaged in distribution in commerce of TCE, without any 
manufacturing or processing activities, to customers for uses that are 
not regulated. EPA is proposing a requirement for downstream 
notification by manufacturers, processors, and distributors of TCE for 
any use to ensure compliance with the prohibition on manufacture, 
processing, distribution in commerce, and commercial use of TCE for 
spot cleaning in dry cleaning facilities and in aerosol degreasers. 
Downstream notification is necessary for effective enforcement of the 
rule because it provides a record, in writing, of notification on use 
restrictions throughout the supply chain, likely via modifications to 
the Safety Data Sheet. Downstream notification also increases awareness 
of restrictions on the use of TCE for spot cleaning in dry cleaning 
facilities and in aerosol degreasers, which is likely to decrease 
unintentional uses of TCE by these entities. Downstream notification 
represents minimal burden and is necessary for effective enforcement of 
the rule. The estimated cost of downstream notification is $51,000 in 
the first year and $3,900 and $5,000 on an annualized basis over 15 
years using 3 and 7 percent discount rates respectively.

C. Enforcement

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

XII. References

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

1. EPA. 2014. TSCA Work Plan Chemical Risk Assessment. 
Trichloroethylene: Degreasing, Spot Cleaning and Arts & Crafts Uses. 
CASRN: 79-01-6. EPA/740/R1/4002. Office of Chemical Safety and 
Pollution Prevention, Washington, DC. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-risk-assessment-0
2. EPA (US Environmental Protection Agency). 2016. Economic 
Assessment for Trichloroethylene (TCE) under TSCA Section 6. Office 
of Chemical Safety and Pollution Prevention, Washington, DC.
3. EPA. Toxicological Review of Trichloroethylene (CAS No. 79-01-6). 
EPA/635/R-09/011F. Integrated Risk Information System, Washington, 
DC. 2011.
4. International Agency for Research on Cancer. Monographs on the 
Evaluation of Carcinogenic Risks to Humans: Cadmium, 
Trichloroethylene, Tetrachloroethylene, and Some Chlorinated Agents. 
Volume 106. World Health Organization, Lyon, France.
5. National Toxicology Program. 13th Report on Carcinogens. 2014. 
Available at https://ntp.niehs.nih.gov/annualreport/2015/glance/roc/.
6. EPA. Protection of Stratospheric Ozone: Listing of Ozone-
Depleting Substances-n-Propyl Bromide in Solvent Cleaning. Final 
Rule. Federal Register (72 FR 30142, May 30, 2007) (FRL-8316-8).
7. Occupational Safety and Health Administration (OSHA). 
Occupational Safety and Health Standards, Toxic and Hazardous 
Substances. Code of Federal Regulations 29 CFR 1910.1000. 1998.
8. OSHA. Permissible Exposure Limits--Annotated Tables. https://www.osha.gov/dsg/annotated-pels/. Retrieved February 26, 2016.
9. OSHA. Chemical Management and Permissible Exposure Limits (PELs). 
Federal Register 79 FR 61384 (October 10, 2014). https://www.regulations.gov/#!documentDetail;D=OSHA-2012-0023-0001
10. National Institute for Occupational Safety and Health (NIOSH). 
Pocket Guide to Chemical Hazards. U.S. Department of Health and 
Human Services, Public Health Service, Centers for Disease Control 
and Prevention. Cincinnati, OH. 1997.
11. American Conference of Governmental Industrial Hygienists 
(ACGIH), Threshold Limit Values & Biological Exposure Indices for 
2003, ACGIH, Cincinnati, OH, 2003.
12. Cal. Code Regs. tit. 17, Sec.  94509 (2013).
13. Toxics Use Reduction Institute (TURI). https://www.turi.org/TURI_Publications/TURI_Chemical_Fact_Sheets/Trichloroethylene_TCE_Fact_Sheet. 2013.
14. Minnesota Department of Health. Chemicals of High Concern List. 
July 1, 2013. https://www.health.state.mn.us/divs/eh/hazardous/topics/toxfreekids/chclist/mdhchc2013.pdf.
15. LawAtlas: The Policy Surveillance Portal. https://lawatlas.org/. 
Retrieved April 4, 2016.
16. European Chemicals Agency. Substance Information: 
Trichloroethylene. https://echa.europa.eu/da/substance-information/-/substanceinfo/100.001.062. Retrieved February 25, 2016.
17. Environment Canada. Priority Substances List Assessment Report-

[[Page 91621]]

Trichloroethylene. Canada Environmental Protection Act. 1993. https://www.hc-sc.gc.ca/ewh-semt/pubs/contaminants/psl1-lsp1/trichloroethylene/index-eng.php. Retrieved March 7, 2016.
18. Environment Canada. Solvent Degreasing Regulations (SOR/2003-
283) https://www.ec.gc.ca/lcpe-cepa/eng/regulations/detailreg.cfm?intReg=76. Retrieved March 7, 2016.
19. Incorporated Administrative Agency National Institute of 
Technology and Evaluation. Chemical Risk Information Platform 
(CHRIP). https://www.safe.nite.go.jp/english/sougou/view/ComprehensiveInfoDisplay_en.faces. Retrieved March 7, 2016.
20. Australian Government Department of Health National Industrial 
Chemicals Notification and Assessment Scheme. AICS Listing. https://www.nicnas.gov.au/regulation-and-compliance/aics/aics-search-page/chemical?id=1092. Retrieved March 7, 2016.
21. EPA. TSCA Work Plan Chemicals: Methods Document. Environmental 
Protection Agency Office of Pollution Prevention and Toxics. 
Washington, DC February 2012. https://www.epa.gov/sites/production/files/2014-03/documents/work_plan_methods_document_web_final.pdf. 
Retrieved February 25, 2016.
22. EPA. TSCA Work Plan Chemicals. Office of Chemical Safety and 
Pollution Prevention. June 2012. https://www.epa.gov/sites/production/files/2014-02/documents/work_plan_chemicals_web_final.pdf. Retrieved February 25, 2016.
23. EPA. Supplemental Occupational Exposure and Risk Reduction 
Technical Report in Support of Risk Management Options for 
Trichloroethylene (TCE) Use in Aerosol Degreasing. Office of 
Chemical Safety and Pollution Prevention. Washington, DC 2016.
24. EPA. Supplemental Exposure and Risk Reduction Technical Report 
in Support of Risk Management Options for Trichloroethylene (TCE) 
Use in Consumer Aerosol Degreasing. Office of Chemical Safety and 
Pollution Prevention. Washington, DC 2016.
25. EPA. Supplemental Occupational Exposure and Risk Reduction 
Technical Report in Support of Risk Management Options for 
Trichloroethylene (TCE) Use in Spot Cleaning. Office of Chemical 
Safety and Pollution Prevention. Washington, DC February 29, 2016.
26. EPA. A Review of the Reference Dose and Reference Concentration 
Processes. EPA/630/P-02/002F. December 2002.
27. EPA. Expert Public Workshop on Alternatives and Risk Reduction 
Approaches to Trichloroethylene. July 29-30, 2014. EPA Docket Number 
EPA-HQ-OPPT-2014-0327-0001.
28. EPA. Regulatory Options Analysis Matrix for TCE Aerosol 
Degreasing [RIN 2070-AK03]. Office of Chemical Safety and Pollution 
Prevention. Washington, DC 2016.
29. EPA. Regulatory Options Analysis Matrix for TCE as a Spot 
Cleaner (Dry Cleaning). [RIN 2070-AK03]. Office of Chemical Safety 
and Pollution Prevention. Washington, DC 2016.
30. OSHA. Respiratory Protection. https://www.osha.gov/SLTC/respiratoryprotection/. Retrieved March 16, 2016.
31. Consumer Specialty Products Association (CSPA). Presentation by 
Steven Bennett at the Expert Public Workshop on Alternatives and 
Risk Reduction Approaches to Trichloroethylene. July 29, 2014.
32. EPA. Analysis Report of Alternatives in Support of Risk 
Management Options for Use of TCE in Aerosol Degreasing and for Spot 
Cleaning in Dry Cleaning Facilities. Office of Chemical Safety and 
Pollution Prevention. Washington, DC 2016.
33. Unintended pregnancy in the United States: Incidence and 
disparities, 2006. Contraception. 2011;84(5):478-485.
34. EPA. Guidelines for Developmental Toxicity Risk Assessment. 
Federal Register 56(234):63798-63826. December 5, 1991.
35. EPA. Guidelines for Reproductive Toxicity Risk Assessment. 
Federal Register 61(212):56274-56322. October 31, 1996.
36. Johnson, P.D., S.J. Goldberg, M.Z. Mays, and B.V. Dawson. 2003. 
Threshold of Trichloroethylene Contamination in Maternal Drinking 
Waters Affecting Fetal Heart Development in the Rat. Environmental 
Health Perspectives, 111(3), 289-292.
37. EPA. The Effectiveness of Labeling on Hazardous Chemicals and 
Other Products. Office of Chemical Safety and Pollution Prevention. 
Washington, DC 2016.
38. United States Consumer Product Safety Commission (CPSC). Human 
Factors Assessment of Strong Magnet Sets. Bethesda, MD. August 2, 
2012.
39. EPA. Recommendations for an Existing Chemical Exposure Limit 
(ECEL) for Occupational Use of Trichloroethylene (TCE) and Sampling 
and Analytical Methods for TCE. Office of Chemical Safety and 
Pollution Prevention. Washington, DC August 28, 2015.
40. Hindin, David A., and Jon D. Silberman. Designing More Effective 
Rules and Permits. George Washington Journal of Energy & 
Environmental Law. 7.2 (2016): 103-23.
41. EPA. Proceedings Report-Stakeholder Roundtables. United States-
Canada Regulatory Cooperation Council: Supply Chain Communication 
and the U.S. EPA's SNUR and EC/HC's SNAc Programs. November 30, 
2015.
42. Dry Cleaning Coalition. State Coalition for Remediation of 
Drycleaners: Chemicals Used In Dry Cleaning Operations. 2009.
43. EPA. November 13, 2014, Meeting with The Drycleaning and Laundry 
Institute.
44. EPA. Evaluation of Water-Based Cleaners. Office of Chemical 
Safety and Pollution Prevention. Washington, DC 2016.
45. NIOSH (National Institute for Occupational Safety and Health). 
Control of Spotting Chemical Hazards in Commercial Drycleaning. 
Publication Number 97-158. Centers for Disease Control and 
Prevention, Atlanta, GA. https://www.cdc.gov/niosh/docs/hazardcontrol/hc20.html.
46. CDC. Facts about Congenital Heart Defects https://www.cdc.gov/ncbddd/heartdefects/facts.html. December 22, 2015. Accessed March 1, 
2016.
47. The National Academies Press, Committee on Developmental 
Toxicology, Board on Environmental Studies and Toxicology, 
Commission on Life Sciences, National Research Council. Scientific 
Frontiers in Developmental Toxicology and Risk Assessment. 
Washington, DC. https://www.nap.edu/read/9871/chapter/4. 2000.
48. Mayo clinic. Chronic kidney disease. https://www.mayoclinic.org/diseases-conditions/kidney-disease/basics/definition/con-20026778. 
January 30, 2015.
49. American Kidney Fund. 2015 Kidney Disease Statistics. https://www.kidneyfund.org/about-us/assets/pdfs/kidney_disease_statistics_2015.pdf
50. The Kidney Boy. The Cost of Dialysis. https://thekidneyboy.blogspot.com/2011/01/cost-of-dialysis.html. January 20, 
2011.
51. Silman AJ, Hochberg MC. Cooper C, et al. Epidemiology of the 
Rheumatic Diseases. Oxford, U.K.: Oxford University Press; 1993:192. 
Cited in Hinchcliff, M.; Varga, Systemic sclerosis/scleroderma: A 
treatable multisystem disease. J. Am Fam Physician. 78(8):961-8. 
2008.
52. Lawrence RC, Helmick CG, Arnett FC, et al. Estimates of the 
prevalence of arthritis and selected musculoskeletal disorders in 
the United States. Arthritis Rheum. 1998;41(5):778-799. Cited in 
Hinchcliff, M.; Varga, Systemic sclerosis/scleroderma: A treatable 
multisystem disease. J. Am Fam Physician. 2008 Oct 15;78(8):961-8.
53. National Cancer Institute. SEER Stat Fact Sheets: Non-Hodgkin 
Lymphoma. Bethesda, MD. https://seer.cancer.gov/statfacts/html/nhl.html. Retrieved March 16, 2016.
54. Mayo Clinic. Non-Hodgkin's Lymphoma Risk Factors. January 28, 
2016. https://www.mayoclinic.org/diseases-conditions/non-hodgkins-lymphoma/basics/risk-factors/con-20027792. Retrieved March 7, 2016.
55. Morton LM, Curtis RE, Linet MS, et al. Second Malignancy Risks 
After Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia: 
Differences by Lymphoma Subtype. Journal of Clinical Oncology. 
2010;28(33):4935-4944. doi:10.1200/JCO.2010.29.1112.
56. Sharma R, Biedenharn KR, Fedor JM, Agarwal A. Lifestyle factors 
and reproductive health: Taking control of your fertility. 
Reproductive Biology and Endocrinology: RB&E. 2013;11:66. 
doi:10.1186/1477-7827-11-66.
57. CDC. National Center for Health Statistics--Infertility. 
February 6, 2015. https://www.cdc.gov/nchs/fastats/infertility.htm 
Retrieved March 16, 2016.

[[Page 91622]]

58. Gruenewald DA, Matsumoto AM. Testosterone supplementation 
therapy for older men: Potential benefits and risks. J Am Geriatr 
Soc. 2003;51(1):101-115.
59. Dadona P, Rosenberg MT. A practical guide to male hypogonadism 
in the primary care setting. Int J Clin Pract. 2010;64(6):682-696.
60. International Association for the Study of Pain. https://www.iasp-pain.org/files/Content/ContentFolders/GlobalYearAgainstPain2/20132014OrofacialPain/FactSheets/Trigeminal_Neuralgia.pdf. 2013.
61. American Liver Foundation. Non-Alcoholic Fatty Liver Disease 
(NAFLD). https://www.liverfoundation.org/abouttheliver/info/nafld/. 
January 14, 2015. Retrieved April 4, 2016.
62. CDC. Viral Hepatitis--Statistics and Surveillance. https://www.cdc.gov/hepatitis/Statistics/index.htm. May 31, 2014. Retrieved 
April 4, 2016.
63. United Network for Organ Sharing (UNOS) Transplant Living. 
Financing a Transplant--Costs. December 28, 2011. Available at 
https://transplantliving.org/before-the-transplant/financing-a-transplant/the-costs/. Retrieved March 16. 2016.
64. United States Consumer Product Safety Commission (CPSC). Letter 
to James J. Jones from Patricia H. Adkins. April 19, 2016.
65. Occupational Safety and Health Administration (OSHA). Letter to 
James J. Jones from David Michaels. April 4 2016.
66. EPA. Section 6(a) Rulemakings under the Toxic Substances Control 
Act (TSCA) Paint Removers & TCE Rulemakings E.O. 13132: Federalism 
Consultation. May 13, 2015.
67. EPA. Notification of Consultation and Coordination on Proposed 
Rulemakings under the Toxic Substances Control Act for (1) Methylene 
Chloride and n-Methylpyrrolidone in Paint Removers and (2) 
Trichloroethylene in Certain Uses. April 8, 2015.

XIII. Statutory and Executive Order Reviews

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

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

    This action is a significant regulatory action because it may raise 
novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles set forth in Executive Order 
12866 (58 FR 51735, October 4, 1993). Accordingly, EPA submitted the 
action to the Office of Management and Budget (OMB) for review under 
Executive Order 12866 and Executive Order 13563 (76 FR 3821, January 
21, 2011), and any changes made in response to OMB recommendations have 
been documented in the docket. EPA prepared an economic analysis of the 
potential costs and benefits associated with this action, which is 
available in the docket and summarized in Unit VIII. (Ref. 2).

B. Paperwork Reduction Act (PRA)

    The information collection requirements in this proposed rule have 
been submitted to OMB for review and comment under the Paperwork 
Reduction Act, 44 U.S.C. 3501 et seq. The Information Collection 
Request (ICR) document prepared by the EPA has been assigned the EPA 
ICR number 2541.01. You can find a copy of the ICR in the docket for 
this proposed rule, and it is briefly summarized here.
    The information collection activities required under the proposed 
rule include a downstream notification requirement and a recordkeeping 
requirement. The downstream notification would require companies that 
ship TCE to notify companies downstream in the supply chain of the 
prohibitions of TCE in the proposed rule. The proposed rule does not 
require the regulated entities to submit information to EPA. The 
proposed rule also does not require confidential or sensitive 
information to be submitted to EPA or downstream companies. The 
recordkeeping requirement mandates companies that ship TCE to retain 
certain information at the company headquarters for two years from the 
date of shipment. These information collection activities are necessary 
in order to enhance the prohibitions under the proposed rule by 
ensuring awareness of the prohibitions throughout the TCE supply chain, 
and to provide EPA with information upon inspection of companies 
downstream who purchased TCE. EPA believes that these information 
collection activities would not significantly impact the regulated 
entities.
    Respondents/affected entities: TCE manufacturers, processors, and 
distributors.
    Respondent's obligation to respond: Mandatory.
    Estimated number of respondents: 697.
    Frequency of response: On occasion.
    Total estimated burden: 348.5 hours (per year). Burden is defined 
at 5 CFR 1320.3(b).
    Total estimated cost: $16,848 (per year).
    An agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for the 
EPA's regulations in 40 CFR are listed in 40 CFR part 9.
    Submit your comments on the Agency's need for this information, the 
accuracy of the provided burden estimates, and any suggested methods 
for minimizing respondent burden to EPA using the docket identified at 
the beginning of this proposed rule. You may also send your ICR-related 
comments to OMB's Office of Information and Regulatory Affairs via 
email to oira_submission@omb.eop.gov, Attention: Desk Officer for the 
EPA. Since OMB is required to make a decision concerning the ICR 
between 30 and 60 days after receipt, OMB must receive comments no 
later than January 17, 2017. The EPA will respond to any ICR-related 
comments in the final rule.

C. Regulatory Flexibility Act (RFA)

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

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more as described in UMRA, 2 U.S.C. 1531-1538, and does not 
significantly or uniquely affect small governments. The requirements of 
this action would primarily affect manufacturers, processors, and 
distributors of TCE. The total estimated annualized cost of the 
proposed rule is approximately

[[Page 91623]]

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

E. Executive Order 13132: Federalism

    The EPA has concluded that this action has federalism implications, 
as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), 
because regulation under TSCA section 6(a) may preempt state law. EPA 
provides the following preliminary federalism summary impact statement. 
The Agency consulted with state and local officials early in the 
process of developing the proposed action to permit them to have 
meaningful and timely input into its development. EPA invited the 
following national organizations representing state and local elected 
officials to a meeting on May 13, 2015, in Washington DC: National 
Governors Association; National Conference of State Legislatures, 
Council of State Governments, National League of Cities, U.S. 
Conference of Mayors, National Association of Counties, International 
City/County Management Association, National Association of Towns and 
Townships, County Executives of America, and Environmental Council of 
States. A summary of the meeting with these organizations, including 
the views that they expressed, is available in the docket (Ref. 65). 
Although EPA provided these organizations an opportunity to provide 
follow-up comments in writing, no written follow-up was received by the 
Agency.

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

    This action does not have tribal implications, as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000). This rulemaking 
would not have substantial direct effects on tribal government because 
TCE is not manufactured, processed, or distributed in commerce by 
tribes. TCE is not regulated by tribes, and this rulemaking would not 
impose substantial direct compliance costs on tribal governments. Thus, 
E.O. 13175 does not apply to this action. EPA nevertheless consulted 
with tribal officials during the development of this action, consistent 
with the EPA Policy on Consultation and Coordination with Indian 
Tribes.
    EPA met with tribal officials in a national informational webinar 
held on May 12, 2015 concerning the prospective regulation of TCE under 
TSCA section 6, and in another teleconference with tribal officials on 
May 27, 2015 (Ref. 66). EPA also met with the National Tribal Toxics 
Council (NTTC) in Washington, DC and via teleconference on April 22, 
2015 (Ref. 66). In those meetings, EPA provided background information 
on the proposed rule and a summary of issues being explored by the 
Agency. These officials expressed concern for TCE contamination on 
tribal lands and supported additional regulation of TCE.

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

    This action is not subject to Executive Order 13045 because it is 
not economically significant as defined in Executive Order 12866. This 
action's health and risk assessment of TCE exposure on children are 
contained in Units VI.B.1.c and VII.B.1.c of this preamble. Supporting 
information on the exposures and health effects of TCE exposure on 
children is also available in the Toxicological Review of 
Trichloroethylene (Ref. 3) and the TCE risk assessment (Ref. 1).

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

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

I. National Technology Transfer and Advancement Act (NTTAA)

    This proposed rulemaking does not involve technical standards.

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

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

List of Subjects in 40 CFR Part 751

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

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

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

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

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

    Authority:  15 U.S.C. 2605.

Subpart A--General Provisions


Sec.  751.1  Purpose.

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


Sec.  751.5  Definitions.

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

[[Page 91624]]

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


Sec.  751.7  Exports and imports.

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


Sec.  751.9  Enforcement and Inspections.

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

Subpart B--[Reserved]

Subpart C--[Reserved]

Subpart D--Trichloroethylene


Sec.  751.301  General.

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


Sec.  751.303  Definitions.

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


Sec.  751.305  Aerosol Degreasing.

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


Sec.  751.307  Spot Cleaning at Dry Cleaning Facilities.

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


Sec.  751.309   [Reserved]


Sec.  751.311  Downstream Notification.

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


Sec.  751.313  Recordkeeping.

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

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