80_FR_47593 80 FR 47441 - Trichloroethylene (TCE); Significant New Use Rule; TCE in Certain Consumer Products

80 FR 47441 - Trichloroethylene (TCE); Significant New Use Rule; TCE in Certain Consumer Products

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 152 (August 7, 2015)

Page Range47441-47448
FR Document2015-19348

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.

Federal Register, Volume 80 Issue 152 (Friday, August 7, 2015)
[Federal Register Volume 80, Number 152 (Friday, August 7, 2015)]
[Proposed Rules]
[Pages 47441-47448]
From the Federal Register Online  [www.thefederalregister.org]
[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.

[[Page 47442]]

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



                                                                          Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules                                                47441

                                                 and their members as well as certain                    reinterpretation of section 518. Some                   Dated: July 31, 2015.
                                                 individual states during the months of                  comments expressed concerns about                     Gina McCarthy,
                                                 June–September, 2014. Records of these                  whether there would be adequate                       Administrator.
                                                 meetings and copies of written                          funding to help tribes administer CWA                 [FR Doc. 2015–19351 Filed 8–6–15; 8:45 am]
                                                 comments and questions submitted by                     regulatory programs after they have                   BILLING CODE 6560–50–P
                                                 states and state associations are                       TAS. EPA considered the tribal
                                                 included in the docket for this rule.                   comments in developing this proposal,
                                                   Some participants expressed                           and will continue to consider tribal                  ENVIRONMENTAL PROTECTION
                                                 concerns, which included: Whether the                                                                         AGENCY
                                                                                                         resource issues in its budgeting and
                                                 proposal would affect the geographic
                                                                                                         planning process. However, EPA cannot
                                                 scope of TAS under the CWA; whether                                                                           40 CFR Part 721
                                                 there is adequate evidence of                           assure tribes that additional funding
                                                 congressional intent; how the proposal                  will be available for a tribe to develop              [EPA–HQ–OPPT–2014–0697; FRL–9930–33]
                                                 would affect a state’s ability to dispute               or implement the CWA regulatory                       RIN 2070–AK50
                                                 a TAS application; and how the                          program it seeks. A tribe choosing to
                                                 proposal would affect the status of                     administer such programs will need to                 Trichloroethylene (TCE); Significant
                                                 existing TAS applications. Some states                  carefully weigh its priorities and any                New Use Rule; TCE in Certain
                                                 also had questions about issues unique                  available EPA assistance.                             Consumer Products
                                                 to their situations. EPA considered this                   EPA specifically solicits additional               AGENCY:  Environmental Protection
                                                 input in developing the proposed rule,                  comment on this proposed action from                  Agency (EPA).
                                                 particularly in developing sections IV.                 tribal officials.                                     ACTION: Proposed rule.
                                                 and V.
                                                   EPA specifically solicits additional                  G. Executive Order 13045: Protection of               SUMMARY:   Under the Toxic Substance
                                                 comment on this proposed action from                    Children From Environmental Health                    Control Act (TSCA), EPA is proposing a
                                                 state officials.                                        Risks and Safety Risks                                significant new use rule (SNUR) for
                                                 F. Executive Order 13175: Consultation                    EPA interprets Executive Order 13045                trichloroethylene (TCE). The proposed
                                                 and Coordination With Indian Tribal                     as applying only to those regulatory                  significant new use is manufacture or
                                                 Governments                                             actions that concern environmental                    processing for use in a consumer
                                                    This action has tribal implications                                                                        product, with a proposed exception for
                                                                                                         health or safety risks that EPA has
                                                 because it would directly affect tribes                                                                       use of TCE in cleaners and solvent
                                                                                                         reason to believe could
                                                 seeking to administer CWA regulatory                                                                          degreasers, film cleaners, hoof polishes,
                                                                                                         disproportionately affect children, per
                                                 programs. However, it would neither                                                                           lubricants, mirror edge sealants, and
                                                                                                         the definition of ‘‘covered regulatory
                                                 impose substantial direct compliance                                                                          pepper spray. Persons subject to the
                                                                                                         action’’ in section 2–202 of the                      SNUR would be required to notify EPA
                                                 costs on federally recognized tribal                    Executive Order. This action is not
                                                 governments, nor preempt tribal law.                                                                          at least 90 days before commencing any
                                                                                                         subject to Executive Order 13045                      manufacturing or processing of TCE for
                                                 EPA consulted and coordinated with                      because it does not concern an
                                                 tribal officials under the EPA Policy on                                                                      a significant new use. The required
                                                                                                         environmental health or safety risk.                  notification would provide EPA with
                                                 Consultation and Coordination with
                                                 Indian Tribes early in the process of                   H. Executive Order 13211: Actions                     the opportunity to evaluate the intended
                                                 developing this regulation to permit                    Concerning Regulations That                           use and, if necessary based on the
                                                 them to have meaningful and timely                      Significantly Affect Energy Supply,                   information available at that time, an
                                                 input into its development. A summary                   Distribution, or Use                                  opportunity to protect against potential
                                                 of that consultation and coordination                                                                         unreasonable risks, if any, from that
                                                 follows.                                                  This action is not subject to Executive             activity before it occurs.
                                                    EPA initiated a tribal consultation and              Order 13211 because it is not a                       DATES: Comments must be received on
                                                 coordination process for this action by                 significant regulatory action under                   or before October 6, 2015.
                                                 sending a ‘‘Notification of Consultation                Executive Order 12866.                                ADDRESSES: Submit your comments,
                                                 and Coordination’’ letter on April 18,                                                                        identified by docket identification (ID)
                                                                                                         I. National Technology Transfer and
                                                 2014, to all 566 federally recognized                                                                         number EPA–HQ–OPPT–2014–0697, by
                                                                                                         Advancement Act (NTTAA)
                                                 tribes. EPA contacted all federally                                                                           one of the following methods:
                                                 recognized tribes, even though only                       This rulemaking does not involve                       • Federal eRulemaking Portal: http://
                                                 tribes with reservations can apply for                  technical standards.                                  www.regulations.gov. Follow the online
                                                 TAS under the CWA, because it is                                                                              instructions for submitting comments.
                                                 possible that additional tribes could                   J. Executive Order 12898: Federal                     Do not submit electronically any
                                                 acquire reservation lands in the future.                Actions To Address Environmental                      information you consider to be
                                                 The letter invited tribal leaders and                   Justice in Minority Populations and                   Confidential Business Information (CBI)
                                                 designated consultation representatives                 Low-Income Populations                                or other information whose disclosure is
                                                 to participate in the tribal consultation                                                                     restricted by statute.
                                                 and coordination process. EPA held two                     This proposed interpretive rule would                 • Mail: Document Control Office
                                                 identical webinars concerning this                      not have potential disproportionately                 (7407M), Office of Pollution Prevention
rmajette on DSK2TPTVN1PROD with PROPOSALS




                                                 matter for tribal representatives on May                high and adverse human health or                      and Toxics (OPPT), Environmental
                                                 22 and May 28, 2014. A total of 70 tribal               environmental effects on minority, low-               Protection Agency, 1200 Pennsylvania
                                                 representatives participated in the two                 income, or indigenous populations. This               Ave. NW., Washington, DC 20460–0001.
                                                 webinars, and tribes and tribal                         action would affect the procedures                       • Hand Delivery: To make special
                                                 organizations sent 23 comment letters to                tribes must follow in order to seek TAS               arrangements for hand delivery or
                                                 EPA.                                                    for CWA regulatory purposes and would                 delivery of boxed information, please
                                                    All tribal comments generally                        not directly affect the level of                      follow the instructions at http://
                                                 supported EPA’s potential                               environmental protection.                             www.epa.gov/dockets/contacts.html.


                                            VerDate Sep<11>2014   15:22 Aug 06, 2015   Jkt 235001   PO 00000   Frm 00013   Fmt 4702   Sfmt 4702   E:\FR\FM\07AUP1.SGM   07AUP1


                                                 47442                    Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules

                                                 Additional instructions on commenting                      • Repair and Maintenance (NAICS                       The proposed significant use EPA has
                                                 or visiting the docket, along with more                 code 811).                                            identified in this unit is a use that EPA
                                                 information about dockets generally, is                    • National Security and International              believes is not ongoing at the time of
                                                 available at http://www.epa.gov/                        Affairs (NAICS code 928).                             this proposed rule. EPA is requesting
                                                 dockets.                                                   This action may also affect certain                public comment on this proposal, and
                                                                                                         entities through pre-existing import                  specifically on the Agency’s
                                                 FOR FURTHER INFORMATION CONTACT:     For
                                                                                                         certification and export notification                 understanding of ongoing uses for the
                                                 technical information contact:
                                                                                                         rules under TSCA. Persons who import                  chemical identified. EPA is particularly
                                                 Katherine Sleasman, Chemical Control
                                                                                                         any chemical substance governed by a                  interested in whether there are any
                                                 Division (7405M), Office of Pollution
                                                                                                         final SNUR are subject to the TSCA                    ongoing uses of this chemical in
                                                 Prevention and Toxics, Environmental
                                                                                                         section 13 (15 U.S.C. 2612) import                    consumer products of which the Agency
                                                 Protection Agency, 1200 Pennsylvania
                                                                                                         certification requirements and the                    is currently unaware. EPA would
                                                 Ave. NW., Washington, DC 20460–0001;
                                                                                                         corresponding regulations at 19 CFR                   welcome specific documentation of any
                                                 telephone number: (202) 564–7716;
                                                                                                         12.118 through 12.127; see also 19 CFR                such ongoing uses. A consumer product
                                                 email address: sleasman.katherine@
                                                                                                         127.28. Those persons must certify that               is defined at 40 CFR 721.3 as ‘‘a
                                                 epa.gov.                                                                                                      chemical substance that is directly, or as
                                                    For general information contact: The                 the shipment of the chemical substance
                                                                                                         complies with all applicable rules and                part of a mixture, sold or made available
                                                 TSCA-Hotline, ABVI-Goodwill, 422                                                                              to consumers for their use in or around
                                                 South Clinton Ave., Rochester, NY                       orders under TSCA, including any
                                                                                                         SNUR requirements. The EPA policy in                  a permanent or temporary household or
                                                 14620; telephone number: (202) 554–                                                                           residence, in or around a school, or in
                                                 1404; email address: TSCA-Hotline@                      support of import certification appears
                                                                                                         at 40 CFR part 707, subpart B. In                     recreation.’’
                                                 epa.gov.                                                                                                         This proposed SNUR would require
                                                                                                         addition, any persons who export or
                                                 SUPPLEMENTARY INFORMATION:                              intend to export a chemical substance                 persons that manufacture (including
                                                                                                                                                               import) or process any of the chemicals
                                                 I. Executive Summary                                    that is the subject of this proposed rule
                                                                                                                                                               for a significant new use, consistent
                                                                                                         on or after September 8, 2015 are subject
                                                 A. Does this action apply to me?                                                                              with the requirements at 40 CFR 721.25,
                                                                                                         to the export notification provisions of
                                                                                                                                                               to notify EPA at least 90 days before
                                                    You may be potentially affected by                   TSCA section 12(b) (15 U.S.C. 2611(b)),
                                                                                                                                                               commencing such manufacture or
                                                 this action if you manufacture, process,                (see 40 CFR 721.20), and must comply
                                                                                                                                                               process of the chemical substance for a
                                                 or distribute in commerce chemical                      with the export notification
                                                                                                                                                               significant new use.
                                                 substances and mixtures. The following                  requirements in 40 CFR part 707,
                                                 list of North American Industrial                       subpart D.                                            D. Why is the agency taking this action?
                                                 Classification System (NAICS) codes is                     If you have any questions regarding                  This SNUR is necessary to ensure that
                                                 not intended to be exhaustive, but rather               the applicability of this action to a                 EPA receives timely advance notice of
                                                 provides a guide to help readers                        particular entity, consult the technical              any future manufacturing and
                                                 determine whether this document                         information contact listed under FOR                  processing of TCE for new uses that may
                                                 applies to them. Potentially affected                   FURTHER INFORMATION CONTACT.                          produce changes in human and
                                                 entities may include:                                                                                         environmental exposures. The rationale
                                                                                                         B. What is the agency’s authority for
                                                    • Textile Product Mills (NAICS code                                                                        and objectives for this SNUR are
                                                                                                         taking this action?
                                                 314).                                                                                                         explained in Unit III.
                                                    • Wood Product Manufacturing                            Section 5(a)(2) of TSCA (15 U.S.C.
                                                 (NAICS code 321).                                       2604(a)(2)) authorizes EPA to determine               E. What are the estimated incremental
                                                    • Printing and Related Support                       that a use of a chemical substance is a               impacts of this action?
                                                 Activities (NAICS code 323).                            ‘‘significant new use.’’ EPA must make                  EPA has evaluated the potential costs
                                                    • Chemical Manufacturing (NAICS                      this determination by rule after                      of establishing SNUR reporting
                                                 code 325).                                              considering all relevant factors,                     requirements for potential
                                                    • Plastics and Rubber Product                        including those listed in TSCA section                manufacturers and processors of the
                                                 Manufacturing (NAICS code 326).                         5(a)(2). Once EPA determines that a use               chemical substance included in this
                                                    • Primary Metal Manufacturing                        of a chemical substance is a significant              proposed rule. This analysis, which is
                                                 (NAICS code 331).                                       new use, TSCA section 5(a)(1)(B)                      available in the docket, is discussed in
                                                    • Fabricated Metal Product                           requires persons to submit a significant              Unit IX., and is briefly summarized
                                                 Manufacturing (NAICS code 332).                         new use notice (SNUN) to EPA at least                 here. In the event that a SNUN is
                                                    • Machinery Manufacturing (NAICS                     90 days before they manufacture                       submitted, costs are estimated to be less
                                                 code 333).                                              (including import) or process the                     than $8,900 per SNUN submission for
                                                    • Computer and Electronic Product                    chemical substance for that use (15                   large business submitters and $6,500 for
                                                 Manufacturing (NAICS code 334).                         U.S.C. 2604(a)(1)(B)). As described in                small business submitters. These
                                                    • Electrical Equipment, Appliance,                   Unit V., the general SNUR provisions                  estimates include the cost to prepare
                                                 and Component Manufacturing (NAICS                      are found at 40 CFR part 721, subpart                 and submit the SNUN and the payment
                                                 code 335).                                              A.                                                    of a user fee. The proposed SNUR
                                                    • Transportation Equipment                                                                                 would require first-time submitters of
                                                                                                         C. What action is the agency taking?
                                                 Manufacturing (NAICS code 336).                                                                               any TSCA section 5 notice to register
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                                                    • Furniture and Product Related                         EPA is proposing a SNUR for                        their company and key users with the
                                                 Manufacturing (NAICS code 337).                         trichloroethylene (TCE). The proposed                 CDX reporting tool, deliver a CDX
                                                    • Miscellaneous Manufacturing                        significant new use is: Manufacturing                 electronic signature to EPA, and
                                                 (NAICS code 339).                                       and processing for any use in a                       establish and use a Pay.gov E-payment
                                                    • Clothing and Clothing Accessory                    consumer product of TCE except for use                account before they may submit a
                                                 Stores (NAICS code 488).                                in cleaners and solvent degreasers, film              SNUN, for a cost of $203 per firm.
                                                    • Warehousing and Storage (NAICS                     cleaners, hoof polishes, lubricants,                  However, these activities are only
                                                 code 493).                                              mirror edge sealants, and pepper spray.               required of first time submitters of


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                                                                          Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules                                          47443

                                                 section 5 notices. In addition, for                     refrigerant chemicals. Much of the                    experimental rodent models. Both
                                                 persons exporting a substance that is the               remainder, less than 14 percent, is used              humans and animals metabolize TCE to
                                                 subject of a SNUR, a one-time notice to                 as a solvent for metals degreasing,                   numerous toxicologically active
                                                 EPA must be provided for the first                      leaving a relatively small percentage to              metabolites to varying degrees. These
                                                 export or intended export to a particular               account for all other uses, including its             metabolites are generated from and
                                                 country, which is estimated to be $83                   use in consumer products. In 2011,                    transported across multiple tissues and
                                                 per notification.                                       global consumption of TCE was 945                     play a key role in causing
                                                                                                         million pounds (lbs) and U.S.                         TCE-associated toxic effects that target
                                                 II. Chemical Substance Subject to This                  consumption was 255 million lbs. Nine                 the liver and kidney (Ref. 1).
                                                 Proposed Rule                                           companies, including domestic                            TCE is characterized as carcinogenic
                                                 A. What chemical is included in the                     manufacturers and importers, reported a               to humans by all routes of exposure as
                                                 proposed SNUR?                                          total production of 224.7 million lbs of              documented in EPA’s TCE Integrated
                                                                                                         TCE in 2011 to the CDR database. Based                Risk Information System (IRIS)
                                                    This proposed SNUR would apply to                                                                          assessment (Ref. 4). This conclusion is
                                                                                                         on the TRI data for 2012, 38 companies
                                                 TCE (Chemical Abstract Services                                                                               based on strong cancer epidemiological
                                                                                                         use TCE as a formulation component, 33
                                                 Registry Number (CASRN 79–01–6)                                                                               data that reported an association
                                                                                                         companies process TCE by repackaging
                                                 manufactured or processed for use in a                                                                        between TCE exposure and the onset of
                                                                                                         the chemical, 28 companies use TCE as
                                                 consumer product except for use in                                                                            various cancers, primarily in the kidney,
                                                                                                         a manufacturing aid, and 1,113
                                                 cleaners and solvent degreasers, film                   companies use TCE for ancillary uses,                 liver and the immune system (i.e.,
                                                 cleaners, hoof polishes, lubricants,                    such as degreasing. Overall, most U.S.                non-Hodgkin lymphoma or NHL).
                                                 mirror edge sealants, and pepper spray.                 consumption is attributable to two                    Further support for TCE’s carcinogenic
                                                 TCE is a volatile organic compound                      specific uses: As an intermediate for                 characterization comes from positive
                                                 (VOC) that is produced and imported                     manufacturing the refrigerant (closed                 results in multiple rodent cancer
                                                 into the United States, with use                        system) HFC–134a (a major alternative                 bioassays in rats and mice of both sexes,
                                                 estimated to be around 250 million                      to CFC–12), and as a solvent for metal                similar toxicokinetics between rodents
                                                 pounds per year. It is a clear, colorless               degreasing (Ref. 1).                                  and humans, mechanistic data
                                                 liquid that has a sweet odor and                                                                              supporting a mutagenic mode of action
                                                 evaporates quickly (Ref. 1).                            C. What are the potential health effects              for kidney tumors, and the lack of
                                                    To ascertain if TCE is used in                       of TCE?                                               mechanistic data supporting the
                                                 consumer products, EPA reviewed                            A broad set of relevant studies                    conclusion that any of the mode(s) of
                                                 published literature, the National                      including epidemiologic studies, animal               action for TCE-induced rodent tumors
                                                 Institute of Health’s (NIH) Household                   bioassays, metabolism studies and                     are irrelevant to humans. Additional
                                                 Product Database (HPD), Safety Data                     mechanistic studies show that TCE                     support comes from the recent
                                                 Sheets (SDSs), data submitted under                     exposure is associated with a wide array              evaluation of TCE’s carcinogenic effects
                                                 EPA’s Chemical Data Reporting (CDR)                     of adverse health effects. TCE has the                by the International Agency for
                                                 rule, and data submitted under EPA’s                    potential to induce neurotoxicity,                    Research on Cancer (IARC). IARC
                                                 Toxics Release Inventory (TRI) and                      immunotoxicity, developmental                         classifies TCE as carcinogenic to
                                                 communicated directly with domestic                     toxicity, liver toxicity, kidney toxicity,            humans (Ref. 5).
                                                 manufacturers and processors (Refs. 1                   endocrine effects, and several forms of                  EPA’s IRIS assessment also concluded
                                                 and 2). From review of these resources                  cancer (Ref. 1).                                      that TCE poses a potential human health
                                                 it was confirmed that the following                        TCE is fat soluble (lipophilic) and                hazard for non-cancer toxicity including
                                                 consumer products containing TCE are                    easily crosses biological membranes. It               neurotoxicity, liver and kidney effects,
                                                 available in retail outlets and e-                      is readily absorbed into the body                     immunotoxicity, reproductive, and
                                                 commerce sites: Cleaners and solvent                    following oral, dermal, or inhalation                 developmental effects. Also evaluated in
                                                 degreasers, film cleaners, hoof polishes,               exposure. Following oral ingestion TCE                the IRIS assessment were TCE’s and its
                                                 lubricants, mirror edge sealants, and                   is rapidly absorbed from the                          metabolites genotoxic effects. As shown
                                                 pepper spray. Cleaners and solvents can                 gastrointestinal tract into the systemic              through the results of in vitro and in
                                                 be used to clean automotive parts,                      circulation (i.e., blood), and its                    vivo tests, TCE has the potential to bind
                                                 fabrics, and carpets. EPA does not                      absorption rate is highly influenced by               or induce damage to the structure of
                                                 believe that there are any other types of               dose of the chemical, dosing vehicle,                 DNA or chromosomes (Ref. 4).
                                                 consumer products containing TCE                        and stomach content. Absorption                          Neurotoxicity has been demonstrated
                                                 (Ref. 1).                                               through the skin has been shown by                    in animal and human studies under
                                                    Following the release of the final risk              both vapor and liquid TCE contact.                    both acute and chronic exposure
                                                 assessment, EPA received a letter from                  Likewise, absorption following                        conditions. Evaluation of the human
                                                 PLZ Aeroscience Corporation on March                    inhalation of TCE is also rapid and the               studies revealed TCE-induced
                                                 5, 2015, indicating their intent to                     inhaled absorbed dose is proportional to              neurotoxic effects including alterations
                                                 reformulate their spray fixative product                the exposure concentration, duration of               in trigeminal nerve and vestibular
                                                 for consumers. Their letter states that                 exposure, and lung ventilation rate.                  function, auditory effects, changes in
                                                 they will no longer manufacture or                      Regardless of the route of exposure, TCE              vision, alterations in cognitive function,
                                                 process spray fixatives with TCE by                     is widely distributed throughout the                  changes in psychomotor effects, and
                                                 September 1, 2015 (Ref. 3). EPA’s                       body. TCE levels can be found in many                 neurodevelopmental outcomes. The
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                                                 review of the resources indicates this is               different tissues including: Brain,                   strongest neurological evidence of
                                                 the only TCE-containing spray fixative                  muscle, heart, kidney, lung, liver, and               human toxicological hazard is for
                                                 that is still used in a consumer product.               adipose tissues. Due to its lipophilicity,            changes in trigeminal nerve function or
                                                                                                         TCE has been found in human maternal                  morphology and impairment of
                                                 B. What are the production volumes and                                                                        vestibular function. Multiple
                                                                                                         and fetal blood and in the breast milk
                                                 uses of TCE?                                                                                                  epidemiological studies in different
                                                                                                         of lactating women (Ref. 1).
                                                   The majority (>80%) of TCE is used                       The metabolism of TCE has been                     populations have reported TCE-induced
                                                 as an intermediate for manufacturing                    extensively studied in humans and                     abnormalities in trigeminal nerve


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                                                 47444                    Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules

                                                 function in humans, and various human                   human and animal developmental                        2 (E–FAST2) Consumer Exposure Model
                                                 studies have consistently reported                      toxicity data suggests an association                 (CEM) for the consumer exposure. EPA
                                                 vestibular system-related symptoms                      between pre- and/or post-natal TCE                    used E–FAST2 CEM because of the lack
                                                 such as headaches, dizziness, and                       exposures and potential adverse                       of available emissions and monitoring
                                                 nausea following TCE exposure (Ref. 1).                 developmental outcomes. TCE-induced                   data for the TCE containing consumer
                                                    Animals and humans exposed to TCE                    heart malformations in animals have                   products (Ref. 1).
                                                 consistently experience liver toxicity.                 been identified as the most sensitive                    For the spray fixatives and solvent
                                                 Specific effects include the following                  developmental toxicity endpoint for                   degreasers used by consumers who
                                                 structural changes: Increased liver                     TCE. Human studies examined the                       experience exposures, there is the
                                                 weight, increase in deoxyribonucleic                    possible association of TCE with various              potential for acute risks that could result
                                                 acid (DNA) synthesis (transient),                       prenatal effects. These adverse effects of            from even one improper use of these
                                                 enlarged hepatocytes, enlarged nuclei,                  developmental TCE exposure could                      products containing TCE. Most
                                                 and peroxisome proliferation. Several                   include death (spontaneous abortion,                  consumers would be unaware of the
                                                 human studies reported an association                   perinatal death, pre- or post-                        potential toxicity of consumer products
                                                 between TCE exposure and significant                    implantation loss, resorptions),                      containing TCE. Consequently,
                                                 changes in serum liver function tests                   decreased growth (low birth weight,                   insufficient and inadequate hazard
                                                 used in diagnosing liver disease, or                    small for gestational age), and                       communication may lead to incorrect
                                                 changes in plasma or serum bile acids.                  congenital malformations, in particular               use and increased consumer and
                                                 There was also human evidence for                       cardiac defects, and postnatal effects                bystander exposures. Even if consumers
                                                 hepatitis accompanying immune-related                   such as growth, survival, developmental               are aware of such potential hazards,
                                                 generalized skin diseases, jaundice,                    neurotoxicity, developmental                          they may not take appropriate
                                                 hepatomegaly, hepatosplenomegaly, and                   immunotoxicity, and childhood cancers.                precautions or research the appropriate
                                                 liver failure in TCE-exposed workers.                   There have also been some                             resources in which these precautions
                                                 For kidney effects, studies in both                     epidemiological studies that have                     are addressed. Of particular concern is
                                                 humans and animals have shown                           consistently reported an increased                    that TCE has harmful effects that occur
                                                 changes in the proximate tubules of the                 incidence of birth defects in                         below the odor threshold, meaning that
                                                 kidney following exposure to TCE. TCE                   TCE-exposed populations from                          smelling the chemical in the home
                                                 metabolites also appear to be the                       exposure to contaminated water. As for                environment is not a sufficient approach
                                                 causative agents that induce renal                      human developmental neurotoxicity,                    to avoid hazardous effects (Ref. 1).
                                                 toxicity (Ref. 1).                                      studies collectively suggest that the
                                                    Immune-related effects following TCE                 developing brain is susceptible to TCE                III. Rationale and Objectives
                                                 exposures have been observed in both                    toxicity. These studies have reported an              A. Rationale
                                                 animal and human studies. In general,                   association with TCE exposure and
                                                 these effects were associated with                      central nervous system birth defects and                 EPA is concerned about the adverse
                                                 inducing enhanced immune responses                      postnatal effects such as delayed                     health effects of TCE resulting from
                                                 as opposed to immunosuppressive                         newborn reflexes, impaired learning or                commercial and consumer uses of the
                                                 effects. Human studies have reported a                  memory, aggressive behavior, hearing                  chemical substance identified for a risk
                                                 relationship between systemic                           impairment, speech impairment,                        assessment as part of EPA’s Existing
                                                 autoimmune diseases, such as                            encephalopathy, impaired executive                    Chemicals Management Program. EPA
                                                 scleroderma with occupational exposure                  and motor function and attention deficit              identified a work plan of 83 chemicals
                                                 to TCE. There have also been a large                    (Ref. 1).                                             including TCE for further assessment
                                                 number of case reports in TCE-exposed                                                                         under the TSCA Work Plan for
                                                 workers developing a severe                             D. What are the potential routes and                  Chemical Assessments in March 2012,
                                                 hypersensitivity skin disorder, often                   sources of exposure to TCE?                           to help focus and direct the activities of
                                                 accompanied by systemic effects to the                     The main route of exposure for TCE                 its Existing Chemicals Management
                                                 lymph nodes and other organs, such as                   is inhalation due to its chemical                     Program. EPA reviewed readily
                                                 hepatitis (Ref. 1).                                     properties and the nature of the                      available information on TCE including
                                                    The toxicological literature provides                consumer products. However, EPA                       uses, physical and chemical properties,
                                                 support for male and female                             recognizes that highly volatile                       fate, exposure potential, and associated
                                                 reproductive toxicity following TCE                     compounds such as TCE may also be                     hazards to humans and the
                                                 exposure. Both the epidemiological and                  absorbed through the skin. (Ref. 1).                  environment. TCE was selected based
                                                 animal studies provide evidence of                         In EPA’s final risk assessment for                 on concerns for its human health hazard
                                                 adverse outcomes to female                              TCE, EPA examined acute risks for                     (e.g., human carcinogen) and its
                                                 reproductive outcomes. However, much                    consumer exposures in residential                     exposure profile (i.e., widely used in
                                                 more extensive evidence exists in                       settings. The assessment identified risks             consumer products and detected in
                                                 support of an association between TCE                   to consumers and residential bystanders               drinking water, indoor environments,
                                                 exposures and male reproductive                         from use of solvent degreasers and                    surface water, ambient air, groundwater,
                                                 toxicity. There is evidence that the                    protective spray coatings, also referred              and soil) using OPPT’s TSCA Work Plan
                                                 metabolism of TCE in male reproductive                  to as spray fixatives, because of either              screening methodology (Ref. 6). In
                                                 tract tissues is associated with adverse                their high TCE content or high potential              EPA’s final risk assessment released on
                                                 effects on sperm measures in both                       for human exposure. TCE is also present               June 25, 2014, the Agency identified
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                                                 humans and animals. Furthermore,                        in film cleaners, and mirror edge                     risks to workers using TCE and non-
                                                 human studies support an association                    sealants, but these products were not                 workers for degreasers and a spot-
                                                 between TCE exposure and alterations                    evaluated because of either their low                 cleaner in dry cleaning uses, and EPA
                                                 in sperm density and quality, as well as                TCE content, less frequent use, or low                also identified health risks to consumers
                                                 changes in sexual drive or function and                 exposure potential. The final risk                    using spray aerosol degreasers and spray
                                                 altered serum endocrine levels (Ref. 1).                assessment calculated indoor air                      fixatives (Ref. 1).
                                                    An evaluation of the overall weight                  concentrations using the Exposure and                    EPA believes that any additional use
                                                 and strength of the evidence of the                     Fast Assessment Screening Tool Version                of this chemical substance in consumer


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                                                                          Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules                                            47445

                                                 products could significantly increase                   use must be made after consideration of                  Provisions relating to user fees appear
                                                 human exposure, and that such                           all relevant factors including:                       at 40 CFR part 700. According to 40 CFR
                                                 exposures should not occur without an                      1. The projected volume of                         721.1(c), persons subject to SNURs must
                                                 opportunity for EPA review and control                  manufacturing and processing of a                     comply with the same notice
                                                 as appropriate. However, as discussed                   chemical substance.                                   requirements and EPA regulatory
                                                 in Unit II, based on review of SDSs and                    2. The extent to which a use changes               procedures as submitters of
                                                 the NIH’s HPD, EPA believes that                        the type or form of exposure of human                 Premanufacture Notices (PMNs) under
                                                 cleaners and solvent degreasers, film                   beings or the environment to a chemical               TSCA section 5(a)(1)(A). In particular,
                                                 cleaners, hoof polishes, lubricants,                    substance.                                            these requirements include the
                                                 mirror edge sealants, and pepper spray                     3. The extent to which a use increases             information submissions requirements
                                                 contain TCE. EPA believes that other                    the magnitude and duration of exposure                of TSCA section 5(b) and 5(d)(1), the
                                                 consumer products do not presently                      of human beings or the environment to                 exemptions authorized by TSCA section
                                                 contain TCE, other than spray fixative                  a chemical substance.                                 5(h)(1), (h)(2), (h)(3), and (h)(5), and the
                                                 product use which will be discontinued                     4. The reasonably anticipated manner               regulations at 40 CFR part 720. Once
                                                 by September 1, 2015 as described in                    and methods of manufacturing,                         EPA receives a SNUN, EPA may take
                                                 Unit II.A.                                              processing, distribution in commerce,                 regulatory action under TSCA section
                                                                                                         and disposal of a chemical substance.                 5(e), 5(f), 6 or 7 to control the activities
                                                    Consistent with EPA’s past practice                     In addition to these factors
                                                 for issuing SNURs under TSCA section                                                                          on which it has received the SNUN. If
                                                                                                         enumerated in TSCA section 5(a)(2), the               EPA does not take action, EPA is
                                                 5(a)(2), EPA’s decision to propose a                    statute authorizes EPA to consider any
                                                 SNUR for a particular chemical use                                                                            required under TSCA section 5(g) to
                                                                                                         other relevant factors.                               explain in the Federal Register its
                                                 need not be based on an extensive                          To determine what would constitute a
                                                 evaluation of the hazard, exposure, or                                                                        reasons for not taking action.
                                                                                                         significant new use of TCE compounds                     Persons who export or intend to
                                                 potential risk associated with that use.                subject to this proposed rule, as
                                                 Rather, the Agency action is based on                                                                         export a chemical substance identified
                                                                                                         discussed in this unit, EPA considered                in a proposed or final SNUR are subject
                                                 EPA’s determination that if the use                     relevant information about the toxicity
                                                 begins or resumes, it may present a risk                                                                      to the export notification provisions of
                                                                                                         of the substance, likely human                        TSCA section 12(b). The regulations that
                                                 that EPA should evaluate under TSCA                     exposures and environmental releases
                                                 before the manufacturing or processing                                                                        interpret TSCA section 12(b) appear at
                                                                                                         associated with possible uses, and the                40 CFR part 707, subpart D. In
                                                 for that use begins. Since the new use                  four factors listed in section 5(a)(2) of
                                                 does not currently exist, deferring a                                                                         accordance with 40 CFR 707.60(b) this
                                                                                                         TSCA. EPA has preliminarily                           proposed SNUR does not trigger export
                                                 detailed consideration of potential risks               determined as the significant new use:                notification for articles. Persons who
                                                 or hazards related to that use is an                    Manufacture or processing for any use                 import a chemical substance identified
                                                 effective use of resources. If a person                 in a consumer product except for use in               in a final SNUR are subject to the TSCA
                                                 decides to begin manufacturing or                       cleaners and solvent degreasers, film                 section 13 import certification
                                                 processing the chemical for the use, the                cleaners, hoof polishes, lubricants,                  requirements, codified at 19 CFR 12.118
                                                 notice to EPA allows EPA to evaluate                    mirror edge sealants, and pepper spray.               through 12.127; see also 19 CFR 127.28.
                                                 the use according to the specific                       Because TCE is not used in consumer                   Those persons must certify that the
                                                 parameters and circumstances                            products (with the limited exceptions of              shipment of the chemical substance
                                                 surrounding that intended use.                          use in cleaners and solvent degreasers,               complies with all applicable rules and
                                                 B. Objectives                                           film cleaners, hoof polishes, lubricants,             orders under TSCA, including any
                                                                                                         mirror edge sealants, pepper spray, and               SNUR requirements. The EPA policy in
                                                    Based on the considerations in Unit                  (before September 1, 2015) spray                      support of import certification appears
                                                 III.A., EPA wants to achieve the                        fixatives), EPA believes new use in                   at 40 CFR part 707, subpart B.
                                                 following objectives with regard to the                 consumer products could increase the
                                                 significant new use(s) that are                         magnitude and duration of human                       VI. Applicability of Rule to Uses
                                                 designated in this proposed rule:                       exposure to TCE. Exposure to TCE                      Occurring Before Effective Date of the
                                                    1. EPA would receive notice of any                   through inhalation may lead to a wide                 Final Rule
                                                 person’s intent to manufacture or                       array of adverse health effects, such as                 As discussed in the Federal Register
                                                 process TCE for the described                           neurotoxicity, immunotoxicity,                        of April 24, 1990 (55 FR 17376; FRL–
                                                 significant new use before that activity                developmental toxicity, liver toxicity,               3658–5) (Ref. 7), EPA has decided that
                                                 begins.                                                 kidney toxicity, endocrine effects, and               the intent of section 5(a)(1)(B) of TSCA
                                                    2. EPA would have an opportunity to                  several forms of cancer, as further                   is best served by designating a use as a
                                                 review and evaluate data submitted in a                 explained in Unit II.C., and because of               significant new use as of the date of
                                                 SNUN before the notice submitter                        these adverse effects EPA would like the              publication of the proposed rule rather
                                                 begins manufacturing or processing TCE                  opportunity to evaluate such potential                than as of the effective date of the final
                                                 for the described significant new use.                  uses in consumer products for any                     rule. If uses begun after publication of
                                                    3. EPA would be able to regulate                     associated risks or hazards that might                the proposed rule were considered
                                                 prospective manufacturers or processors                 exist before those uses would begin.                  ongoing rather than new, it would be
                                                 of TCE before the described significant                                                                       difficult for EPA to establish SNUR
                                                 new use of the chemical substance                       V. Applicability of General Provisions                notice requirements, because a person
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                                                 occurs, provided that regulation is                        General provisions for SNURs appear                could defeat the SNUR by initiating the
                                                 warranted pursuant to TSCA section                      under 40 CFR part 721, subpart A.                     proposed significant new use before the
                                                 5(e), 5(f), 6 or 7.                                     These provisions describe persons                     rule became final, and then argue that
                                                                                                         subject to the rule, recordkeeping                    the use was ongoing as of the effective
                                                 IV. Significant New Use Determination
                                                                                                         requirements, exemptions to reporting                 date of the final rule. Thus, persons who
                                                   Section 5(a)(2) of TSCA states that                   requirements, and applicability of the                begin commercial manufacture or
                                                 EPA’s determination that a use of a                     rule to uses occurring before the                     processing of the chemical substance(s)
                                                 chemical substance is a significant new                 effective date of the final rule.                     that would be regulated through this


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                                                 47446                    Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules

                                                 proposed rule, if finalized, would have                 the agency before submitting a SNUN.                  fee required by 40 CFR 700.45(b)(2)(iii),
                                                 to cease any such activity before the                   As part of this optional pre-notice                   or, if they are a small business with
                                                 effective date of the rule if and when                  consultation, EPA would discuss                       annual sales of less than $40 million
                                                 finalized. To resume their activities,                  specific data it believes may be useful               when combined with those of the parent
                                                 these persons would have to comply                      in evaluating a significant new use.                  company (if any), a reduced user fee of
                                                 with all applicable SNUR notice                         SNUNs submitted for significant new                   $100 (40 CFR 700.45(b)(1)). EPA’s
                                                 requirements and wait until the notice                  uses without any test data may increase               complete economic analysis is available
                                                 review period, including all extensions,                the likelihood that EPA will take action              in the public docket for this proposed
                                                 expires. Uses arising after the                         under TSCA section 5(e) to prohibit or                rule (Ref. 2).
                                                 publication of the proposed rule are                    limit activities associated with this                 B. Export Notification
                                                 distinguished from uses that exist at                   chemical.
                                                 publication of the proposed rule. The                                                                            Under section 12(b) of TSCA and the
                                                                                                           SNUN submitters should be aware                     implementing regulations at 40 CFR part
                                                 former would be new uses, the latter                    that EPA will be better able to evaluate
                                                 ongoing uses, except that uses that are                                                                       707, subpart D, exporters must notify
                                                                                                         SNUNs that provide detailed                           EPA if they export or intend to export
                                                 ongoing as of the publication of the
                                                                                                         information on:                                       a chemical substance or mixture for
                                                 proposed rule would not be considered                     • Human exposure and
                                                 ongoing uses if they have ceased by the                                                                       which, among other things, a rule has
                                                                                                         environmental releases that may result                been proposed or promulgated under
                                                 date of issuance of a final rule.                       from the significant new uses of the
                                                 However, recognizing the use in a                                                                             TSCA section 5. For persons exporting
                                                                                                         chemical substance;                                   a substance that is the subject of a
                                                 consumer product of TCE in spray                          • Potential benefits of the chemical
                                                 fixatives will cease by September 1,                                                                          SNUR, a one-time notice to EPA must be
                                                                                                         substance; and
                                                 2015 as described in Unit II.A., EPA                                                                          provided for the first export or intended
                                                                                                           • Information on risks posed by the
                                                 considers September 1, 2015 as the date                                                                       export to a particular country. The total
                                                                                                         chemical substances compared to risks
                                                 from which the significant new use with                                                                       costs of export notification will vary by
                                                                                                         posed by potential substitutes.
                                                 respect only to such spray fixatives                                                                          chemical, depending on the number of
                                                 would be designated. To the extent that                 VIII. SNUN Submissions                                required notifications (i.e., the number
                                                 additional ongoing uses are found in the                  EPA recommends that submitters                      of countries to which the chemical is
                                                 course of rulemaking, EPA would                         consult with the Agency prior to                      exported). While EPA is unable to make
                                                 exclude those specific uses from the                    submitting a SNUN to discuss what data                any estimate of the likely number of
                                                 final SNUR. EPA has promulgated                         may be useful in evaluating a significant             export notifications for the chemical
                                                 provisions to allow persons to comply                   new use. Discussions with the Agency                  covered in this proposed SNUR, as
                                                 with the final SNUR before the effective                prior to submission can afford ample                  stated in the accompanying economic
                                                 date. If a person were to meet the                      time to conduct any tests that might be               analysis of this proposed SNUR, the
                                                 conditions of advance compliance                        helpful in evaluating risks posed by the              estimated cost of the export notification
                                                 under 40 CFR 721.45(h), that person                     substance. According to 40 CFR                        requirement on a per unit basis is $83.
                                                 would be considered to have met the                     721.1(c), persons submitting a SNUN                   X. Alternatives
                                                 requirements of the final SNUR for                      must comply with the same notice
                                                 those activities.                                                                                               Before proposing this SNUR, EPA
                                                                                                         requirements and EPA regulatory                       considered the following alternative
                                                 VII. Test Data and Other Information                    procedures as persons submitting a                    regulatory action: Promulgate a TSCA
                                                                                                         PMN, including submission of test data                Section 8(a) Reporting Rule.
                                                    EPA recognizes that TSCA section 5
                                                                                                         on health and environmental effects as                  Under a TSCA section 8(a) rule, EPA
                                                 does not usually require developing any
                                                                                                         described in 40 CFR 720.50. SNUNs                     could, among other things, generally
                                                 particular test data before submission of
                                                                                                         must be submitted on EPA Form No.                     require persons to report information to
                                                 a SNUN. There are two exceptions:
                                                    1. Development of test data is                       7710–25, generated using e-PMN                        the agency when they intend to
                                                 required where the chemical substance                   software, and submitted to the Agency                 manufacture or process a listed
                                                 subject to the SNUR is also subject to a                in accordance with the procedures set                 chemical for a specific use or any use.
                                                 test rule under TSCA section 4 (see                     forth in 40 CFR 721.25 and 40 CFR                     However, for TCE, the use of TSCA
                                                 TSCA section 5(b)(1)); and                              720.40. E–PMN software is available                   section 8(a) rather than SNUR authority
                                                    2. Development of test data may be                   electronically at http://www.epa.gov/                 would have several limitations. First, if
                                                 necessary where the chemical substance                  opptintr/newchems.                                    EPA were to require reporting under
                                                 has been listed under TSCA section                      IX. Economic Analysis                                 TSCA section 8(a) instead of TSCA
                                                 5(b)(4) (see TSCA section 5(b)(2)).                                                                           section 5(a), EPA would not have the
                                                 In the absence of a section 4 test rule or              A. SNUNs                                              opportunity to review human and
                                                 a section 5(b)(4) listing covering the                    EPA has evaluated the potential costs               environmental hazards and exposures
                                                 chemical substance, persons are                         of establishing SNUR reporting                        associated with the proposed significant
                                                 required to submit only test data in their              requirements for potential                            new use and, if necessary, take
                                                 possession or control and to describe                   manufacturers and processors of the                   immediate follow-up regulatory action
                                                 any other data known to or reasonably                   chemical substance included in this                   under TSCA section 5(e) or 5(f) to
                                                 ascertainable by them (15 U.S.C.                        proposed rule (Ref. 2). In the event that             prohibit or limit the activity before it
                                                 2604(d); 40 CFR 721.25, and 40 CFR                      a SNUN is submitted, costs are                        begins. In addition, EPA may not
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                                                 720.50). However, as a general matter,                  estimated at approximately $8,900 per                 receive important information from
                                                 EPA recommends that SNUN submitters                     SNUN submission for large business                    small businesses, because such firms
                                                 include data that would permit a                        submitters and $6,500 for small                       generally are exempt from TSCA section
                                                 reasoned evaluation of risks posed by                   business submitters. These estimates                  8(a) reporting requirements (see TSCA
                                                 the chemical substance during its                       include the cost to prepare and submit                sections 8(a)(1)(A) and 8(a)(1)(B)). In
                                                 manufacture, processing, use,                           the SNUN, and the payment of a user                   view of the level of health concerns
                                                 distribution in commerce, or disposal.                  fee. Businesses that submit a SNUN                    about TCE if used for the proposed
                                                 EPA encourages persons to consult with                  would be subject to either a $2,500 user              significant new use, EPA believes that a


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                                                                          Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules                                           47447

                                                 TSCA section 8(a) rule for this                            2. Tips for preparing your comments.               XIII. Statutory and Executive Order
                                                 substance would not meet EPA’s                          When submitting comments, remember                    Reviews
                                                 regulatory objectives.                                  to:
                                                                                                                                                               A. Executive Order 12866: Regulatory
                                                                                                            i. Identify the document by docket ID              Planning and Review and Executive
                                                 XI. Request for Comment                                 number and other identifying                          Order 13563: Improving Regulation and
                                                 A. Do you have comments or                              information (subject heading, Federal                 Regulatory Review
                                                 information about ongoing uses?                         Register date, and page number).
                                                                                                            ii. Follow directions. The agency may                 This proposed SNUR is not a
                                                    EPA welcomes comment on all                          ask you to respond to specific questions              ‘‘significant regulatory action’’ under
                                                 aspects of this proposed rule. EPA based                or organize comments by referencing a                 the terms of the Executive Order 12866
                                                 its understanding of the use profile of                 CFR part or section number.                           (58 FR 51735, October 4, 1993) and is
                                                 these chemicals on the published                           iii. Explain why you agree or disagree;            therefore not subject to review under
                                                 literature, the 2012 CDR submissions,                   suggest alternatives and substitute                   Executive Order 12866 and 13563,
                                                 market research, discussions with                       language for your requested changes.                  entitled ‘‘Improving Regulation and
                                                 manufacturers, and review of SDSs. To                      iv. Describe any assumptions and                   Regulatory Review’’ (76 FR 3821,
                                                 confirm EPA’s understanding, the                        provide any technical information and/                January 21, 2011).
                                                 Agency is requesting public comment                     or data that you used.                                B. Paperwork Reduction Act (PRA)
                                                 on the EPA’s understanding that                            v. If you estimate potential costs or
                                                 cleaners and solvent degreasers, film                                                                            This action does not impose any new
                                                                                                         burdens, explain how you arrived at                   information collection burden under the
                                                 cleaners, hoof polishes, lubricants,                    your estimate in sufficient detail to
                                                 mirror edge sealants, and pepper spray                                                                        PRA, 44 U.S.C. 3501 et seq. Burden is
                                                                                                         allow for it to be reproduced.                        defined in 5 CFR 1320.3(b). The
                                                 contain TCE. The Agency is also                            vi. Provide specific examples to
                                                 requesting public comment if any of the                                                                       information collection activities
                                                                                                         illustrate your concerns and suggest                  associated with existing chemical
                                                 listed uses that contain TCE are no                     alternatives.
                                                 longer available to consumers. EPA                                                                            SNURs are already approved by OMB
                                                                                                            vii. Explain your views as clearly as              under OMB control number 2070–0038
                                                 believes that other consumer products                   possible, avoiding the use of profanity
                                                 do not contain TCE, however, EPA is                                                                           (EPA ICR No. 1188); and the
                                                                                                         or personal threats.                                  information collection activities
                                                 interested in information indicating that
                                                                                                            viii. Make sure to submit your                     associated with export notifications are
                                                 there are other ongoing uses of TCE in
                                                                                                         comments by the comment period                        already approved by OMB under OMB
                                                 consumer products. In providing
                                                                                                         deadline identified.                                  control number 2070–0030 (EPA ICR
                                                 comments on an ongoing use of TCE in
                                                 a consumer product, it would be helpful                 XII. References                                       No. 0795). If an entity were to submit a
                                                 if you provide sufficient information for                                                                     SNUN to the Agency, the annual burden
                                                                                                           The following is a listing of the                   is estimated to be less than 100 hours
                                                 EPA to substantiate any assertions of                   documents that are specifically
                                                 use.                                                                                                          per response, and the estimated burden
                                                                                                         referenced in this document. The docket               for export notifications is less than 1.5
                                                 B. What should I consider as I prepare                  includes these documents and other                    hours per notification. In both cases,
                                                 my comments for EPA?                                    information considered by EPA,                        burden is estimated to be reduced for
                                                                                                         including documents that are referenced               submitters who have already registered
                                                   1. Submitting CBI. It is EPA’s policy                 within the documents that are included                to use the electronic submission system.
                                                 to include all comments received in the                 in the docket, even if the referenced                    An agency may not conduct or
                                                 public docket without change or further                 document is not physically located in                 sponsor, and a person is not required to
                                                 notice to the commenter and to make                     the docket. For assistance in locating                respond to a collection of information
                                                 the comments available on-line at                       these other documents, please consult                 that requires OMB approval under the
                                                 www.regulations.gov, including any                      the technical person listed under FOR                 PRA, unless it has been approved by
                                                 personal information provided, unless a                 FURTHER INFORMATION CONTACT.                          OMB and displays a currently valid
                                                 comment includes information claimed                    1. U.S. EPA. Final Risk Assessment on                 OMB control number. The OMB control
                                                 to be CBI or other information whose                         Trichloroethylene (TCE). June 25, 2014.          numbers for EPA’s regulations in title 40
                                                 disclosure is restricted by statute. Do                 2. U.S. EPA. Economic Analysis of the                 of the CFR, after appearing in the
                                                 not submit this information to EPA                           Significant New Use Rule for                     Federal Register, are listed in 40 CFR
                                                 through regulations.gov or email.                            Trichloroethylene. February 19, 2015.            part 9, and included on the related
                                                 Clearly mark the part or all of the                     3. Letter from PLZ Aeroscience Corporation.           collection instrument, or form, if
                                                 information that you claim to be CBI.                        March 5, 2015.
                                                                                                         4. U.S. EPA. (2011). Toxicological Review of
                                                                                                                                                               applicable.
                                                 For CBI information in a disk or CD
                                                 ROM that you mail to EPA, mark the                           Trichloroethylene (CAS No. 79–01–6).             C. Regulatory Flexibility Act (RFA)
                                                                                                              EPA/635/R–09/011F. Integrated Risk
                                                 outside of the disk or CD ROM that you                       Information System, Washington, DC.                 Pursuant to section 605(b) of the RFA,
                                                 mail to EPA as CBI and then identify                    5. IARC (2014). International Agency for              5 U.S.C. 601 et seq., I hereby certify that
                                                 electronically within the disk or CD                         Research on Cancer. Monographs on the            promulgation of this SNUR would not
                                                 ROM the specific information that is                         Evaluation of Carcinogenic Risks to              have a significant economic impact on
                                                 claimed as CBI. In addition to one                           Humans: Cadmium, Trichloroethylene,              a substantial number of small entities.
                                                 complete version of the comment that                         Tetrachloroethylene, and Some                    The rationale supporting this
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                                                 includes information claimed as CBI, a                       Chlorinated Agents, Volume 106. World            conclusion is as follows.
                                                 copy of the comment that does not                            Health Organization, Lyon, France.                  A SNUR applies to any person
                                                 contain the information claimed as CBI                  6. U.S. EPA. (2014). TSCA Work Plan for               (including small or large entities) who
                                                                                                              Chemical Assessments: 2014 Update.
                                                 must be submitted for inclusion in the                       Washington. DC.
                                                                                                                                                               intends to engage in any activity
                                                 public docket. Information so marked                    7. U.S. EPA. Significant New Uses of Certain          described in the rule as a ‘‘significant
                                                 will not be disclosed except in                              Chemical Substances. Federal Register            new use.’’ By definition of the word
                                                 accordance with procedures set forth in                      of April 24, 1990, (55 FR 173776) (FRL–          ‘‘new’’ and based on all information
                                                 40 CFR part 2, subpart B.                                    3658–5).                                         currently available to EPA, it appears


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                                                 47448                    Federal Register / Vol. 80, No. 152 / Friday, August 7, 2015 / Proposed Rules

                                                 that no small or large entities presently               Executive Order 13132 (64 FR 43255,                     Dated: July 30, 2015.
                                                 engage in such activities. Since this                   August 10, 1999).                                     Wendy C. Hamnett,
                                                 SNUR will require a person who intends                                                                        Director, Office of Pollution Prevention and
                                                                                                         F. Executive Order 13175: Consultation
                                                 to engage in such activity in the future                                                                      Toxics.
                                                                                                         and Coordination With Indian Tribal
                                                 to first notify EPA by submitting a                                                                             Therefore, it is proposed that 40 CFR
                                                                                                         Governments
                                                 SNUN, no economic impact will occur                                                                           chapter I be amended as follows:
                                                 unless someone files a SNUN to pursue                      This proposed rule does not have
                                                 a significant new use in the future or                  Tribal implications because it is not                 PART 721—[AMENDED]
                                                 forgoes profits by avoiding or delaying                 expected to have any effect (i.e., there
                                                 the significant new use. Although some                  will be no increase or decrease in                    ■ 1. The authority citation for part 721
                                                 small entities may decide to conduct                    authority or jurisdiction) on Tribal                  continues to read as follows:
                                                 such activities in the future, EPA cannot               governments, on the relationship                        Authority: 15 U.S.C. 2604, 2607, and
                                                 presently determine how many, if any,                   between the Federal government and                    2625(c).
                                                 there may be. However, EPA’s                            the Indian tribes, or on the distribution             ■ 2. Add § 721.10851 to subpart E to
                                                 experience to date is that, in response to              of power and responsibilities between                 read as follows:
                                                 the promulgation of SNURs covering                      the Federal government and Indian
                                                 over 1,000 chemical substances, the                     tribes. Thus, Executive Order 13175 (65               § 721.10851       Trichloroethylene.
                                                 Agency receives only a handful of                       FR 67249, November 9, 2000) does not                     (a) Chemical substance and
                                                 notices per year. During the six year                   apply to this action.                                 significant new uses subject to reporting.
                                                 period from 2005–2010, only three                                                                             (1) The chemical substance
                                                 submitters self-identified as small in                  G. Executive Order 13045: Protection of               trichloroethylene (CAS 79–01–6) is
                                                 their SNUN submission (Ref. 2). EPA                     Children from Environmental Health                    subject to reporting under this section
                                                 believes the cost of submitting a SNUN                  Risks and Safety Risks                                for the significant new use described in
                                                 is relatively small compared to the cost                  This action is not subject to Executive             paragraph (a)(2) of this section.
                                                 of developing and marketing a chemical                                                                           (2) Manufacture or processing for use
                                                                                                         Order 13045 (62 FR 19885, April 23,
                                                 new to a firm or marketing a new use                                                                          in a consumer product except for use in
                                                                                                         1997), because this action is not
                                                 of the chemical and that the                                                                                  cleaners and solvent degreasers, film
                                                                                                         intended to address environmental
                                                 requirement to submit a SNUN                                                                                  cleaners, hoof polishes, lubricants,
                                                                                                         health or safety risks for children.
                                                 generally does not have a significant                                                                         mirror edge sealants, and pepper spray.
                                                 economic impact.                                        H. Executive Order 13211: Actions                        (b) [Reserved]
                                                    Therefore, EPA believes that the                     Concerning Regulations That                           [FR Doc. 2015–19348 Filed 8–6–15; 8:45 am]
                                                 potential economic impact of complying                  Significantly Affect Energy Supply,                   BILLING CODE 6560–50–P
                                                 with this proposed SNUR is not                          Distribution, or Use
                                                 expected to be significant or adversely
                                                                                                           This proposed rule is not subject to
                                                 impact a substantial number of small                                                                          FEDERAL COMMUNICATIONS
                                                                                                         Executive Order 13211 (66 FR 28355,
                                                 entities. In a SNUR that published as a                                                                       COMMISSION
                                                                                                         May 22, 2001), because this action is not
                                                 final rule on August 8, 1997 (62 FR
                                                                                                         expected to affect energy supply,
                                                 42690) (FRL–5735–4), the Agency                                                                               47 CFR Part 54
                                                                                                         distribution, or use.
                                                 presented its general determination that                                                                      [WC Docket Nos. 10–90 and 14–259; Report
                                                 proposed and final SNURs are not                        I. National Technology Transfer and                   3025]
                                                 expected to have a significant economic                 Advancement Act (NTTAA)
                                                 impact on a substantial number of small                                                                       Petition for Reconsideration of Action
                                                 entities, which was provided to the                       Since this action does not involve any              in a Rulemaking Proceeding
                                                 Chief Counsel for Advocacy of the Small                 technical standards, section 12(d) of
                                                 Business Administration.                                NTTAA, 15 U.S.C. 272 note, does not                   AGENCY:  Federal Communications
                                                                                                         apply to this action.                                 Commission.
                                                 D. Unfunded Mandates Reform Act                                                                               ACTION: Petition for reconsideration.
                                                 (UMRA)                                                  J. Executive Order 12898: Federal
                                                                                                         Actions To Address Environmental                      SUMMARY:   A Petition for Reconsideration
                                                   Based on EPA’s experience with                        Justice in Minority Populations and                   (Petition) has been filed in the
                                                 proposing and finalizing SNURs, State,                  Low-Income Populations                                Commission’s Rulemaking proceeding
                                                 local, and Tribal governments have not                                                                        by Harold Mordkofsky, on behalf of
                                                 been impacted by these rulemakings,                        This proposed rule does not invoke
                                                                                                         special consideration of environmental                Halstad Telephone Company.
                                                 and EPA does not have any reason to
                                                                                                         justice related issues as delineated by               DATES: Oppositions to the Petition must
                                                 believe that any State, local, or Tribal
                                                 government would be impacted by this                    Executive Order 12898 (59 FR 7629,                    be filed on or before August 24, 2015.
                                                 rulemaking. As such, the requirements                   February 16, 1994), because EPA has                   Replies to an opposition must be filed
                                                 of sections 202, 203, 204, or 205 of                    determined that this action will not                  on or before September 1, 2015.
                                                 UMRA, 2 U.S.C. 1531–1538, do not                        have disproportionately high and                      ADDRESSES: Federal Communications
                                                 apply to this action.                                   adverse human health or environmental                 Commission, 445 12th Street SW.,
                                                                                                         effects on minority or low-income                     Washington, DC 20554.
                                                 E. Executive Order 13132: Federalism
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                                                                                                         populations. This action does not affect              FOR FURTHER INFORMATION CONTACT:
                                                   This action will not have a substantial               the level of protection provided to                   Alexander Minard, Telecommunications
                                                 direct effect on States, on the                         human health or the environment.                      Access Policy Division, Wireline
                                                 relationship between the national                       List of Subjects in 40 CFR Part 721                   Competition Bureau, (202) 418–7400,
                                                 government and the States, or on the                                                                          email: Alexander.Minard@fcc.gov, TTY
                                                 distribution of power and                                 Environmental protection, Chemicals,                (202) 418–0484.
                                                 responsibilities among the various                      Hazardous substances, Reporting and                   SUPPLEMENTARY INFORMATION: This is a
                                                 levels of government, as specified in                   recordkeeping requirements.                           summary of Commission’s document,


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Document Created: 2015-12-15 10:56:35
Document Modified: 2015-12-15 10:56:35
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesComments must be received on or before October 6, 2015.
ContactFor 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:
FR Citation80 FR 47441 
RIN Number2070-AK50
CFR AssociatedEnvironmental Protection; Chemicals; Hazardous Substances and Reporting and Recordkeeping Requirements

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