[Federal Register Volume 80, Number 152 (Friday, August 7, 2015)]
[Proposed Rules]
[Pages 47441-47448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19348]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2014-0697; FRL-9930-33]
RIN 2070-AK50


Trichloroethylene (TCE); Significant New Use Rule; TCE in Certain 
Consumer Products

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Under the Toxic Substance Control Act (TSCA), EPA is proposing 
a significant new use rule (SNUR) for trichloroethylene (TCE). The 
proposed significant new use is manufacture or processing for use in a 
consumer product, with a proposed exception for use of TCE in cleaners 
and solvent degreasers, film cleaners, hoof polishes, lubricants, 
mirror edge sealants, and pepper spray. Persons subject to the SNUR 
would be required to notify EPA at least 90 days before commencing any 
manufacturing or processing of TCE for a significant new use. The 
required notification would provide EPA with the opportunity to 
evaluate the intended use and, if necessary based on the information 
available at that time, an opportunity to protect against potential 
unreasonable risks, if any, from that activity before it occurs.

DATES: Comments must be received on or before October 6, 2015.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2014-0697, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.

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Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Katherine Sleasman, Chemical Control Division (7405M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-7716; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or distribute in commerce chemical substances and mixtures. 
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:
     Textile Product Mills (NAICS code 314).
     Wood Product Manufacturing (NAICS code 321).
     Printing and Related Support Activities (NAICS code 323).
     Chemical Manufacturing (NAICS code 325).
     Plastics and Rubber Product Manufacturing (NAICS code 
326).
     Primary Metal Manufacturing (NAICS code 331).
     Fabricated Metal Product Manufacturing (NAICS code 332).
     Machinery Manufacturing (NAICS code 333).
     Computer and Electronic Product Manufacturing (NAICS code 
334).
     Electrical Equipment, Appliance, and Component 
Manufacturing (NAICS code 335).
     Transportation Equipment Manufacturing (NAICS code 336).
     Furniture and Product Related Manufacturing (NAICS code 
337).
     Miscellaneous Manufacturing (NAICS code 339).
     Clothing and Clothing Accessory Stores (NAICS code 488).
     Warehousing and Storage (NAICS code 493).
     Repair and Maintenance (NAICS code 811).
     National Security and International Affairs (NAICS code 
928).
    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 SNUR 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, including any SNUR requirements. 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 on or after 
September 8, 2015 are subject to the export notification provisions of 
TSCA section 12(b) (15 U.S.C. 2611(b)), (see 40 CFR 721.20), 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 
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?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including those listed in TSCA section 5(a)(2). Once 
EPA determines that a use of a chemical substance is a significant new 
use, TSCA section 5(a)(1)(B) requires persons to submit a significant 
new use notice (SNUN) to EPA at least 90 days before they manufacture 
(including import) or process the chemical substance for that use (15 
U.S.C. 2604(a)(1)(B)). As described in Unit V., the general SNUR 
provisions are found at 40 CFR part 721, subpart A.

C. What action is the agency taking?

    EPA is proposing a SNUR for trichloroethylene (TCE). The proposed 
significant new use is: Manufacturing and processing for any use in a 
consumer product of TCE except for use in cleaners and solvent 
degreasers, film cleaners, hoof polishes, lubricants, mirror edge 
sealants, and pepper spray.
    The proposed significant use EPA has identified in this unit is a 
use that EPA believes is not ongoing at the time of this proposed rule. 
EPA is requesting public comment on this proposal, and specifically on 
the Agency's understanding of ongoing uses for the chemical identified. 
EPA is particularly interested in whether there are any ongoing uses of 
this chemical in consumer products of which the Agency is currently 
unaware. EPA would welcome specific documentation of any such ongoing 
uses. A consumer product is defined at 40 CFR 721.3 as ``a chemical 
substance that is directly, or as part of a mixture, sold or made 
available to consumers for their use in or around a permanent or 
temporary household or residence, in or around a school, or in 
recreation.''
    This proposed SNUR would require persons that manufacture 
(including import) or process any of the chemicals for a significant 
new use, consistent with the requirements at 40 CFR 721.25, to notify 
EPA at least 90 days before commencing such manufacture or process of 
the chemical substance for a significant new use.

D. Why is the agency taking this action?

    This SNUR is necessary to ensure that EPA receives timely advance 
notice of any future manufacturing and processing of TCE for new uses 
that may produce changes in human and environmental exposures. The 
rationale and objectives for this SNUR are explained in Unit III.

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

    EPA has evaluated the potential costs of establishing SNUR 
reporting requirements for potential manufacturers and processors of 
the chemical substance included in this proposed rule. This analysis, 
which is available in the docket, is discussed in Unit IX., and is 
briefly summarized here. In the event that a SNUN is submitted, costs 
are estimated to be less than $8,900 per SNUN submission for large 
business submitters and $6,500 for small business submitters. These 
estimates include the cost to prepare and submit the SNUN and the 
payment of a user fee. The proposed SNUR would require first-time 
submitters of any TSCA section 5 notice to register their company and 
key users with the CDX reporting tool, deliver a CDX electronic 
signature to EPA, and establish and use a Pay.gov E-payment account 
before they may submit a SNUN, for a cost of $203 per firm. However, 
these activities are only required of first time submitters of

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section 5 notices. In addition, for persons exporting a substance that 
is the subject of a SNUR, a one-time notice to EPA must be provided for 
the first export or intended export to a particular country, which is 
estimated to be $83 per notification.

II. Chemical Substance Subject to This Proposed Rule

A. What chemical is included in the proposed SNUR?

    This proposed SNUR would apply to TCE (Chemical Abstract Services 
Registry Number (CASRN 79-01-6) manufactured or processed for use in a 
consumer product except for use in cleaners and solvent degreasers, 
film cleaners, hoof polishes, lubricants, mirror edge sealants, and 
pepper spray. TCE is a volatile organic compound (VOC) that is produced 
and imported into the United States, with use estimated to be around 
250 million pounds per year. It is a clear, colorless liquid that has a 
sweet odor and evaporates quickly (Ref. 1).
    To ascertain if TCE is used in consumer products, EPA reviewed 
published literature, the National Institute of Health's (NIH) 
Household Product Database (HPD), Safety Data Sheets (SDSs), data 
submitted under EPA's Chemical Data Reporting (CDR) rule, and data 
submitted under EPA's Toxics Release Inventory (TRI) and communicated 
directly with domestic manufacturers and processors (Refs. 1 and 2). 
From review of these resources it was confirmed that the following 
consumer products containing TCE are available in retail outlets and e-
commerce sites: Cleaners and solvent degreasers, film cleaners, hoof 
polishes, lubricants, mirror edge sealants, and pepper spray. Cleaners 
and solvents can be used to clean automotive parts, fabrics, and 
carpets. EPA does not believe that there are any other types of 
consumer products containing TCE (Ref. 1).
    Following the release of the final risk assessment, EPA received a 
letter from PLZ Aeroscience Corporation on March 5, 2015, indicating 
their intent to reformulate their spray fixative product for consumers. 
Their letter states that they will no longer manufacture or process 
spray fixatives with TCE by September 1, 2015 (Ref. 3). EPA's review of 
the resources indicates this is the only TCE-containing spray fixative 
that is still used in a consumer product.

B. What are the production volumes and uses of TCE?

    The majority (>80%) of TCE is used as an intermediate for 
manufacturing refrigerant chemicals. Much of the remainder, less than 
14 percent, is used as a solvent for metals degreasing, leaving a 
relatively small percentage to account for all other uses, including 
its use in consumer products. In 2011, global consumption of TCE was 
945 million pounds (lbs) and U.S. consumption was 255 million lbs. Nine 
companies, including domestic manufacturers and importers, reported a 
total production of 224.7 million lbs of TCE in 2011 to the CDR 
database. Based on the TRI data for 2012, 38 companies use TCE as a 
formulation component, 33 companies process TCE by repackaging the 
chemical, 28 companies use TCE as a manufacturing aid, and 1,113 
companies use TCE for ancillary uses, such as degreasing. Overall, most 
U.S. consumption is attributable to two specific uses: As an 
intermediate for manufacturing the refrigerant (closed system) HFC-134a 
(a major alternative to CFC-12), and as a solvent for metal degreasing 
(Ref. 1).

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 a wide array of adverse health effects. 
TCE has the potential to induce neurotoxicity, immunotoxicity, 
developmental toxicity, liver toxicity, kidney toxicity, endocrine 
effects, and several forms of cancer (Ref. 1).
    TCE is fat soluble (lipophilic) and easily crosses biological 
membranes. It is readily absorbed into the body following oral, dermal, 
or inhalation exposure. Following oral ingestion TCE is rapidly 
absorbed from the gastrointestinal tract into the systemic circulation 
(i.e., blood), and its absorption rate is highly influenced by dose of 
the chemical, dosing vehicle, and stomach content. Absorption through 
the skin has been shown by both vapor and liquid TCE contact. Likewise, 
absorption following inhalation of TCE is also rapid and the inhaled 
absorbed dose is proportional to the exposure concentration, duration 
of exposure, and lung ventilation rate. Regardless of the route of 
exposure, TCE is widely distributed throughout the body. TCE levels can 
be found in many different tissues including: Brain, muscle, heart, 
kidney, lung, liver, and adipose tissues. Due to its lipophilicity, TCE 
has been found in human maternal and fetal blood and in the breast milk 
of lactating women (Ref. 1).
    The metabolism of TCE has been extensively studied in humans and 
experimental rodent models. Both humans and animals metabolize TCE to 
numerous toxicologically active metabolites to varying degrees. These 
metabolites are generated from and transported across multiple tissues 
and play a key role in causing TCE[hyphen]associated toxic effects that 
target the liver and kidney (Ref. 1).
    TCE is characterized as carcinogenic to humans by all routes of 
exposure as documented in EPA's TCE Integrated Risk Information System 
(IRIS) assessment (Ref. 4). This conclusion is based on strong cancer 
epidemiological data that reported an association between TCE exposure 
and the onset of various cancers, primarily in the kidney, liver and 
the immune system (i.e., non[hyphen]Hodgkin lymphoma or NHL). Further 
support for TCE's carcinogenic characterization comes from positive 
results in multiple rodent cancer bioassays in rats and mice of both 
sexes, similar toxicokinetics between rodents and humans, mechanistic 
data supporting a mutagenic mode of action for kidney tumors, and the 
lack of mechanistic data supporting the conclusion that any of the 
mode(s) of action for TCE[hyphen]induced rodent tumors are irrelevant 
to humans. Additional support comes from the recent evaluation of TCE's 
carcinogenic effects by the International Agency for Research on Cancer 
(IARC). IARC classifies TCE as carcinogenic to humans (Ref. 5).
    EPA's IRIS assessment also concluded that TCE poses a potential 
human health hazard for non-cancer toxicity including neurotoxicity, 
liver and kidney effects, immunotoxicity, reproductive, and 
developmental effects. Also evaluated in the IRIS assessment were TCE's 
and its metabolites genotoxic effects. As shown through the results of 
in vitro and in vivo tests, TCE has the potential to bind or induce 
damage to the structure of DNA or chromosomes (Ref. 4).
    Neurotoxicity has been demonstrated in animal and human studies 
under both acute and chronic exposure conditions. Evaluation of the 
human studies revealed TCE[hyphen]induced neurotoxic effects including 
alterations in trigeminal nerve and vestibular function, auditory 
effects, changes in vision, alterations in cognitive function, changes 
in psychomotor effects, and neurodevelopmental outcomes. The strongest 
neurological evidence of human toxicological hazard is for changes in 
trigeminal nerve function or morphology and impairment of vestibular 
function. Multiple epidemiological studies in different populations 
have reported TCE[hyphen]induced abnormalities in trigeminal nerve

[[Page 47444]]

function in humans, and various human studies have consistently 
reported vestibular system[hyphen]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 deoxyribonucleic acid (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[hyphen]related generalized skin diseases, jaundice, 
hepatomegaly, hepatosplenomegaly, and liver failure in 
TCE[hyphen]exposed workers. For kidney effects, studies in both humans 
and animals have shown changes in the proximate tubules of the kidney 
following exposure to TCE. TCE metabolites also appear to be the 
causative agents that induce renal toxicity (Ref. 1).
    Immune[hyphen]related effects following TCE exposures have been 
observed in both 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[hyphen]exposed workers developing a severe 
hypersensitivity skin disorder, often accompanied by systemic effects 
to the lymph nodes and other organs, such as hepatitis (Ref. 1).
    The toxicological literature provides support for male and female 
reproductive toxicity following TCE exposure. Both the epidemiological 
and animal studies provide evidence of adverse outcomes to female 
reproductive outcomes. However, much more extensive evidence exists in 
support of an association between TCE exposures and male reproductive 
toxicity. There is evidence that the 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).
    An evaluation of the overall weight and strength of the evidence of 
the human and animal developmental toxicity data suggests an 
association between pre[hyphen] and/or post-natal TCE exposures and 
potential adverse developmental outcomes. TCE[hyphen]induced heart 
malformations in animals have been identified as the most sensitive 
developmental toxicity endpoint for TCE. Human studies examined the 
possible association of TCE with various prenatal effects. These 
adverse effects of developmental TCE exposure could include death 
(spontaneous abortion, perinatal death, pre- or post-implantation loss, 
resorptions), decreased growth (low birth weight, small for gestational 
age), and congenital malformations, in particular cardiac defects, and 
postnatal effects such as growth, survival, developmental 
neurotoxicity, developmental immunotoxicity, and childhood cancers. 
There have also been some epidemiological studies that have 
consistently reported an increased incidence of birth defects in 
TCE[hyphen]exposed populations from exposure to contaminated water. As 
for human developmental neurotoxicity, studies collectively suggest 
that the developing brain is susceptible to TCE toxicity. These studies 
have reported an association with TCE exposure and central nervous 
system birth defects and postnatal effects such as delayed newborn 
reflexes, impaired learning or memory, aggressive behavior, hearing 
impairment, speech impairment, encephalopathy, impaired executive and 
motor function and attention deficit (Ref. 1).

D. What are the potential routes and sources of exposure to TCE?

    The main route of exposure for TCE is inhalation due to its 
chemical properties and the nature of the consumer products. However, 
EPA recognizes that highly volatile compounds such as TCE may also be 
absorbed through the skin. (Ref. 1).
    In EPA's final risk assessment for TCE, EPA examined acute risks 
for consumer exposures in residential settings. The assessment 
identified risks to consumers and residential bystanders from use of 
solvent degreasers and protective spray coatings, also referred to as 
spray fixatives, because of either their high TCE content or high 
potential for human exposure. TCE is also present in film cleaners, and 
mirror edge sealants, but these products were not evaluated because of 
either their low TCE content, less frequent use, or low exposure 
potential. The final risk assessment calculated indoor air 
concentrations using the Exposure and Fast Assessment Screening Tool 
Version 2 (E-FAST2) Consumer Exposure Model (CEM) for the consumer 
exposure. EPA used E-FAST2 CEM because of the lack of available 
emissions and monitoring data for the TCE containing consumer products 
(Ref. 1).
    For the spray fixatives and solvent degreasers used by consumers 
who experience exposures, there is the potential for acute risks that 
could result from even one improper use of these products containing 
TCE. Most consumers would be unaware of the potential toxicity of 
consumer products containing TCE. Consequently, insufficient and 
inadequate hazard communication may lead to incorrect use and increased 
consumer and bystander exposures. Even if consumers are aware of such 
potential hazards, they may not take appropriate precautions or 
research the appropriate resources in which these precautions are 
addressed. Of particular concern is that TCE has harmful effects that 
occur below the odor threshold, meaning that smelling the chemical in 
the home environment is not a sufficient approach to avoid hazardous 
effects (Ref. 1).

III. Rationale and Objectives

A. Rationale

    EPA is concerned about the adverse health effects of TCE resulting 
from commercial and consumer uses of the chemical substance identified 
for a risk assessment as part of EPA's Existing Chemicals Management 
Program. EPA identified a work plan of 83 chemicals including TCE for 
further assessment under the TSCA Work Plan for Chemical Assessments in 
March 2012, to help focus and direct the activities of its Existing 
Chemicals Management Program. EPA reviewed readily available 
information on TCE including uses, physical and chemical properties, 
fate, exposure potential, and associated hazards to humans and the 
environment. TCE was selected based on concerns for its human health 
hazard (e.g., human carcinogen) and its exposure profile (i.e., widely 
used in consumer products and detected in drinking water, indoor 
environments, surface water, ambient air, groundwater, and soil) using 
OPPT's TSCA Work Plan screening methodology (Ref. 6). In EPA's final 
risk assessment released on June 25, 2014, the Agency identified risks 
to workers using TCE and non-workers for degreasers and a spot-cleaner 
in dry cleaning uses, and EPA also identified health risks to consumers 
using spray aerosol degreasers and spray fixatives (Ref. 1).
    EPA believes that any additional use of this chemical substance in 
consumer

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products could significantly increase human exposure, and that such 
exposures should not occur without an opportunity for EPA review and 
control as appropriate. However, as discussed in Unit II, based on 
review of SDSs and the NIH's HPD, EPA believes that cleaners and 
solvent degreasers, film cleaners, hoof polishes, lubricants, mirror 
edge sealants, and pepper spray contain TCE. EPA believes that other 
consumer products do not presently contain TCE, other than spray 
fixative product use which will be discontinued by September 1, 2015 as 
described in Unit II.A.
    Consistent with EPA's past practice for issuing SNURs under TSCA 
section 5(a)(2), EPA's decision to propose a SNUR for a particular 
chemical use need not be based on an extensive evaluation of the 
hazard, exposure, or potential risk associated with that use. Rather, 
the Agency action is based on EPA's determination that if the use 
begins or resumes, it may present a risk that EPA should evaluate under 
TSCA before the manufacturing or processing for that use begins. Since 
the new use does not currently exist, deferring a detailed 
consideration of potential risks or hazards related to that use is an 
effective use of resources. If a person decides to begin manufacturing 
or processing the chemical for the use, the notice to EPA allows EPA to 
evaluate the use according to the specific parameters and circumstances 
surrounding that intended use.

B. Objectives

    Based on the considerations in Unit III.A., EPA wants to achieve 
the following objectives with regard to the significant new use(s) that 
are designated in this proposed rule:
    1. EPA would receive notice of any person's intent to manufacture 
or process TCE for the described significant new use before that 
activity begins.
    2. EPA would have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing TCE for the described significant new use.
    3. EPA would be able to regulate prospective manufacturers or 
processors of TCE before the described significant new use of the 
chemical substance occurs, provided that regulation is warranted 
pursuant to TSCA section 5(e), 5(f), 6 or 7.

IV. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors including:
    1. The projected volume of manufacturing and processing of a 
chemical substance.
    2. The extent to which a use changes the type or form of exposure 
of human beings or the environment to a chemical substance.
    3. The extent to which a use increases the magnitude and duration 
of exposure of human beings or the environment to a chemical substance.
    4. The reasonably anticipated manner and methods of manufacturing, 
processing, distribution in commerce, and disposal of a chemical 
substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorizes EPA to consider any other relevant factors.
    To determine what would constitute a significant new use of TCE 
compounds subject to this proposed rule, as discussed in this unit, EPA 
considered relevant information about the toxicity of the substance, 
likely human exposures and environmental releases associated with 
possible uses, and the four factors listed in section 5(a)(2) of TSCA. 
EPA has preliminarily determined as the significant new use: 
Manufacture or processing for any use in a consumer product except for 
use in cleaners and solvent degreasers, film cleaners, hoof polishes, 
lubricants, mirror edge sealants, and pepper spray. Because TCE is not 
used in consumer products (with the limited exceptions of use in 
cleaners and solvent degreasers, film cleaners, hoof polishes, 
lubricants, mirror edge sealants, pepper spray, and (before September 
1, 2015) spray fixatives), EPA believes new use in consumer products 
could increase the magnitude and duration of human exposure to TCE. 
Exposure to TCE through inhalation may lead to a wide array of adverse 
health effects, such as neurotoxicity, immunotoxicity, developmental 
toxicity, liver toxicity, kidney toxicity, endocrine effects, and 
several forms of cancer, as further explained in Unit II.C., and 
because of these adverse effects EPA would like the opportunity to 
evaluate such potential uses in consumer products for any associated 
risks or hazards that might exist before those uses would begin.

V. Applicability of General Provisions

    General provisions for SNURs appear under 40 CFR part 721, subpart 
A. These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the final 
rule.
    Provisions relating to user fees appear at 40 CFR part 700. 
According to 40 CFR 721.1(c), persons subject to SNURs must comply with 
the same notice requirements and EPA regulatory procedures as 
submitters of Premanufacture Notices (PMNs) under TSCA section 
5(a)(1)(A). In particular, these requirements include the information 
submissions requirements of TSCA section 5(b) and 5(d)(1), the 
exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and 
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a 
SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6 
or 7 to control the activities on which it has received the SNUN. If 
EPA does not take action, EPA is required under TSCA section 5(g) to 
explain in the Federal Register its reasons for not taking action.
    Persons who export or intend to export a chemical substance 
identified in a proposed or final SNUR are subject to the export 
notification provisions of TSCA section 12(b). The regulations that 
interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. In 
accordance with 40 CFR 707.60(b) this proposed SNUR does not trigger 
export notification for articles. Persons who import a chemical 
substance identified in a final SNUR are subject to the TSCA section 13 
import certification requirements, codified 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, including any SNUR requirements. The EPA policy 
in support of import certification appears at 40 CFR part 707, subpart 
B.

VI. Applicability of Rule to Uses Occurring Before Effective Date of 
the Final Rule

    As discussed in the Federal Register of April 24, 1990 (55 FR 
17376; FRL-3658-5) (Ref. 7), EPA has decided that the intent of section 
5(a)(1)(B) of TSCA is best served by designating a use as a significant 
new use as of the date of publication of the proposed rule rather than 
as of the effective date of the final rule. If uses begun after 
publication of the proposed rule were considered ongoing rather than 
new, it would be difficult for EPA to establish SNUR notice 
requirements, because a person could defeat the SNUR by initiating the 
proposed significant new use before the rule became final, and then 
argue that the use was ongoing as of the effective date of the final 
rule. Thus, persons who begin commercial manufacture or processing of 
the chemical substance(s) that would be regulated through this

[[Page 47446]]

proposed rule, if finalized, would have to cease any such activity 
before the effective date of the rule if and when finalized. To resume 
their activities, these persons would have to comply with all 
applicable SNUR notice requirements and wait until the notice review 
period, including all extensions, expires. Uses arising after the 
publication of the proposed rule are distinguished from uses that exist 
at publication of the proposed rule. The former would be new uses, the 
latter ongoing uses, except that uses that are ongoing as of the 
publication of the proposed rule would not be considered ongoing uses 
if they have ceased by the date of issuance of a final rule. However, 
recognizing the use in a consumer product of TCE in spray fixatives 
will cease by September 1, 2015 as described in Unit II.A., EPA 
considers September 1, 2015 as the date from which the significant new 
use with respect only to such spray fixatives would be designated. To 
the extent that additional ongoing uses are found in the course of 
rulemaking, EPA would exclude those specific uses from the final SNUR. 
EPA has promulgated provisions to allow persons to comply with the 
final SNUR before the effective date. If a person were to meet the 
conditions of advance compliance under 40 CFR 721.45(h), that person 
would be considered to have met the requirements of the final SNUR for 
those activities.

VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not usually require 
developing any particular test data before submission of a SNUN. There 
are two exceptions:
    1. Development of test data is required where the chemical 
substance subject to the SNUR is also subject to a test rule under TSCA 
section 4 (see TSCA section 5(b)(1)); and
    2. Development of test data may be necessary where the chemical 
substance has been listed under TSCA section 5(b)(4) (see TSCA section 
5(b)(2)).

In the absence of a section 4 test rule or a section 5(b)(4) listing 
covering the chemical substance, persons are required to submit only 
test data in their possession or control and to describe any other data 
known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 
721.25, and 40 CFR 720.50). However, as a general matter, EPA 
recommends that SNUN submitters include data that would permit a 
reasoned evaluation of risks posed by the chemical substance during its 
manufacture, processing, use, distribution in commerce, or disposal. 
EPA encourages persons to consult with the agency before submitting a 
SNUN. As part of this optional pre-notice consultation, EPA would 
discuss specific data it believes may be useful in evaluating a 
significant new use. SNUNs submitted for significant new uses without 
any test data may increase the likelihood that EPA will take action 
under TSCA section 5(e) to prohibit or limit activities associated with 
this chemical.

    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs that provide detailed information on:
     Human exposure and environmental releases that may result 
from the significant new uses of the chemical substance;
     Potential benefits of the chemical substance; and
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    EPA recommends that submitters consult with the Agency prior to 
submitting a SNUN to discuss what data may be useful in evaluating a 
significant new use. Discussions with the Agency prior to submission 
can afford ample time to conduct any tests that might be helpful in 
evaluating risks posed by the substance. According to 40 CFR 721.1(c), 
persons submitting a SNUN must comply with the same notice requirements 
and EPA regulatory procedures as persons submitting a PMN, including 
submission of test data on health and environmental effects as 
described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 
7710-25, generated using e-PMN software, and submitted to the Agency in 
accordance with the procedures set forth in 40 CFR[emsp14]721.25 and 40 
CFR 720.40. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

IX. Economic Analysis

A. SNUNs

    EPA has evaluated the potential costs of establishing SNUR 
reporting requirements for potential manufacturers and processors of 
the chemical substance included in this proposed rule (Ref. 2). In the 
event that a SNUN is submitted, costs are estimated at approximately 
$8,900 per SNUN submission for large business submitters and $6,500 for 
small business submitters. These estimates include the cost to prepare 
and submit the SNUN, and the payment of a user fee. Businesses that 
submit a SNUN would be subject to either a $2,500 user fee required by 
40 CFR 700.45(b)(2)(iii), or, if they are a small business with annual 
sales of less than $40 million when combined with those of the parent 
company (if any), a reduced user fee of $100 (40 CFR 700.45(b)(1)). 
EPA's complete economic analysis is available in the public docket for 
this proposed rule (Ref. 2).

B. Export Notification

    Under section 12(b) of TSCA and the implementing regulations at 40 
CFR part 707, subpart D, exporters must notify EPA if they export or 
intend to export a chemical substance or mixture for which, among other 
things, a rule has been proposed or promulgated under TSCA section 5. 
For persons exporting a substance that is the subject of a SNUR, a one-
time notice to EPA must be provided for the first export or intended 
export to a particular country. The total costs of export notification 
will vary by chemical, depending on the number of required 
notifications (i.e., the number of countries to which the chemical is 
exported). While EPA is unable to make any estimate of the likely 
number of export notifications for the chemical covered in this 
proposed SNUR, as stated in the accompanying economic analysis of this 
proposed SNUR, the estimated cost of the export notification 
requirement on a per unit basis is $83.

X. Alternatives

    Before proposing this SNUR, EPA considered the following 
alternative regulatory action: Promulgate a TSCA Section 8(a) Reporting 
Rule.
    Under a TSCA section 8(a) rule, EPA could, among other things, 
generally require persons to report information to the agency when they 
intend to manufacture or process a listed chemical for a specific use 
or any use. However, for TCE, the use of TSCA section 8(a) rather than 
SNUR authority would have several limitations. First, if EPA were to 
require reporting under TSCA section 8(a) instead of TSCA section 5(a), 
EPA would not have the opportunity to review human and environmental 
hazards and exposures associated with the proposed significant new use 
and, if necessary, take immediate follow-up regulatory action under 
TSCA section 5(e) or 5(f) to prohibit or limit the activity before it 
begins. In addition, EPA may not receive important information from 
small businesses, because such firms generally are exempt from TSCA 
section 8(a) reporting requirements (see TSCA sections 8(a)(1)(A) and 
8(a)(1)(B)). In view of the level of health concerns about TCE if used 
for the proposed significant new use, EPA believes that a

[[Page 47447]]

TSCA section 8(a) rule for this substance would not meet EPA's 
regulatory objectives.

XI. Request for Comment

A. Do you have comments or information about ongoing uses?

    EPA welcomes comment on all aspects of this proposed rule. EPA 
based its understanding of the use profile of these chemicals on the 
published literature, the 2012 CDR submissions, market research, 
discussions with manufacturers, and review of SDSs. To confirm EPA's 
understanding, the Agency is requesting public comment on the EPA's 
understanding that cleaners and solvent degreasers, film cleaners, hoof 
polishes, lubricants, mirror edge sealants, and pepper spray contain 
TCE. The Agency is also requesting public comment if any of the listed 
uses that contain TCE are no longer available to consumers. EPA 
believes that other consumer products do not contain TCE, however, EPA 
is interested in information indicating that there are other ongoing 
uses of TCE in consumer products. In providing comments on an ongoing 
use of TCE in a consumer product, it would be helpful if you provide 
sufficient information for EPA to substantiate any assertions of use.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. It is EPA's policy to include all comments 
received in the public docket without change or further notice to the 
commenter and to make the comments available on-line at 
www.regulations.gov, including any personal information provided, 
unless a comment includes information claimed to be CBI or other 
information whose disclosure is restricted by statute. Do not submit 
this information to EPA through regulations.gov or email. Clearly mark 
the part or all of the information that you claim to be CBI. For CBI 
information in a disk or CD ROM that you mail to EPA, mark the outside 
of the disk or CD ROM that you mail to EPA as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is claimed as CBI. In addition to one complete version of the comment 
that includes information claimed as CBI, a copy of the comment that 
does not contain the information claimed as CBI must be submitted for 
inclusion in the public docket. Information so marked will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2, subpart B.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date, and page number).
    ii. Follow directions. The agency may ask you to respond to 
specific questions or organize comments by referencing a CFR part or 
section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

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 that are 
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. U.S. EPA. Final Risk Assessment on Trichloroethylene (TCE). June 
25, 2014.
2. U.S. EPA. Economic Analysis of the Significant New Use Rule for 
Trichloroethylene. February 19, 2015.
3. Letter from PLZ Aeroscience Corporation. March 5, 2015.
4. U.S. EPA. (2011). Toxicological Review of Trichloroethylene (CAS 
No. 79-01-6). EPA/635/R-09/011F. Integrated Risk Information System, 
Washington, DC.
5. IARC (2014). 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.
6. U.S. EPA. (2014). TSCA Work Plan for Chemical Assessments: 2014 
Update. Washington. DC.
7. U.S. EPA. Significant New Uses of Certain Chemical Substances. 
Federal Register of April 24, 1990, (55 FR 173776) (FRL-3658-5).

XIII. Statutory and Executive Order Reviews

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

    This proposed SNUR is not a ``significant regulatory action'' under 
the terms of the Executive Order 12866 (58 FR 51735, October 4, 1993) 
and is therefore not subject to review under Executive Order 12866 and 
13563, entitled ``Improving Regulation and Regulatory Review'' (76 FR 
3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden 
under the PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR 
1320.3(b). The information collection activities associated with 
existing chemical SNURs are already approved by OMB under OMB control 
number 2070-0038 (EPA ICR No. 1188); and the information collection 
activities associated with export notifications are already approved by 
OMB under OMB control number 2070-0030 (EPA ICR No. 0795). If an entity 
were to submit a SNUN to the Agency, the annual burden is estimated to 
be less than 100 hours per response, and the estimated burden for 
export notifications is less than 1.5 hours per notification. In both 
cases, burden is estimated to be reduced for submitters who have 
already registered to use the electronic submission system.
    An agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information that requires OMB approval 
under the PRA, unless it has been approved by OMB and displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in title 40 of the CFR, after appearing in the Federal 
Register, are listed in 40 CFR part 9, and included on the related 
collection instrument, or form, if applicable.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I 
hereby certify that promulgation of this SNUR would not have a 
significant economic impact on a substantial number of small entities. 
The rationale supporting this conclusion is as follows.
    A SNUR applies to any person (including small or large entities) 
who intends to engage in any activity described in the rule as a 
``significant new use.'' By definition of the word ``new'' and based on 
all information currently available to EPA, it appears

[[Page 47448]]

that no small or large entities presently engage in such activities. 
Since this SNUR will require a person who intends to engage in such 
activity in the future to first notify EPA by submitting a SNUN, no 
economic impact will occur unless someone files a SNUN to pursue a 
significant new use in the future or forgoes profits by avoiding or 
delaying the significant new use. Although some small entities may 
decide to conduct such activities in the future, EPA cannot presently 
determine how many, if any, there may be. However, EPA's experience to 
date is that, in response to the promulgation of SNURs covering over 
1,000 chemical substances, the Agency receives only a handful of 
notices per year. During the six year period from 2005-2010, only three 
submitters self-identified as small in their SNUN submission (Ref. 2). 
EPA believes the cost of submitting a SNUN is relatively small compared 
to the cost of developing and marketing a chemical new to a firm or 
marketing a new use of the chemical and that the requirement to submit 
a SNUN generally does not have a significant economic impact.
    Therefore, EPA believes that the potential economic impact of 
complying with this proposed SNUR is not expected to be significant or 
adversely impact a substantial number of small entities. In a SNUR that 
published as a final rule on August 8, 1997 (62 FR 42690) (FRL-5735-4), 
the Agency presented its general determination that proposed and final 
SNURs are not expected to have a significant economic impact on a 
substantial number of small entities, which was provided to the Chief 
Counsel for Advocacy of the Small Business Administration.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reason to believe that any 
State, local, or Tribal government would be impacted by this 
rulemaking. As such, the requirements of sections 202, 203, 204, or 205 
of UMRA, 2 U.S.C. 1531-1538, do not apply to this action.

E. Executive Order 13132: Federalism

    This action will not have a substantial direct effect on States, on 
the relationship between the national government and the States, or on 
the distribution of power and responsibilities among the various levels 
of government, as specified in Executive Order 13132 (64 FR 43255, 
August 10, 1999).

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

    This proposed rule does not have Tribal implications because it is 
not expected to have any effect (i.e., there will be no increase or 
decrease in authority or jurisdiction) on Tribal governments, on the 
relationship between the Federal government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
government and Indian tribes. Thus, Executive Order 13175 (65 FR 67249, 
November 9, 2000) does not apply to this action.

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

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997), because this action is not intended to address 
environmental health or safety risks for children.

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

I. National Technology Transfer and Advancement Act (NTTAA)

    Since this action does not involve any technical standards, section 
12(d) of NTTAA, 15 U.S.C. 272 note, does not apply to this action.

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

    This proposed rule does not invoke special consideration of 
environmental justice related issues as delineated by Executive Order 
12898 (59 FR 7629, February 16, 1994), because EPA has determined that 
this action will not have disproportionately high and adverse human 
health or environmental effects on minority or low-income populations. 
This action does not affect the level of protection provided to human 
health or the environment.

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: July 30, 2015.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 721--[AMENDED]

0
1. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

0
2. Add Sec.  721.10851 to subpart E to read as follows:


Sec.  721.10851  Trichloroethylene.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance trichloroethylene (CAS 79-01-6) 
is subject to reporting under this section for the significant new use 
described in paragraph (a)(2) of this section.
    (2) Manufacture or processing for use in a consumer product except 
for use in cleaners and solvent degreasers, film cleaners, hoof 
polishes, lubricants, mirror edge sealants, and pepper spray.
    (b) [Reserved]

[FR Doc. 2015-19348 Filed 8-6-15; 8:45 am]
 BILLING CODE 6560-50-P