Significant New Use Rules on Certain Chemical Substances (19-5.B), 47923-47930 [2019-19579]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 84, Number 176 (Wednesday, September 11, 2019)]
[Proposed Rules]
[Pages 47923-47930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19579]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2019-0495; FRL-9999-27]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (19-5.B)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for 6 chemical substances which are 
the subject of premanufacture notices (PMNs). This action would require 
persons to notify EPA at least 90 days before commencing manufacture 
(defined by statute to include import) or processing of any of these 6 
chemical substances for an activity that is designated as a significant 
new use by this proposed rule. This action would further require that 
persons not commence manufacture or processing for the significant new 
use until they have submitted a Significant New Use Notice, and EPA has 
conducted a review of the notice, made an appropriate determination on 
the notice under TSCA 5(a)(3), and has taken any risk

[[Page 47924]]

management actions as are required as a result of that determination.

DATES: Comments must be received on or before October 11, 2019.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2019-0495, by one of the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Kenneth Moss, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-9232; 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. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture 
(including import), process, or use the chemical substances contained 
in this proposed rule. 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:
     Manufacturers (including importers) or processors of one 
or more subject chemical substances (NAICS codes 325 and 324110), e.g., 
chemical manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements promulgated at 19 CFR 12.118 through 12.127 
and 19 CFR 127.28. Chemical importers must certify that the shipment of 
the chemical substance complies with all applicable rules and orders 
under TSCA. Importers of chemicals subject to these proposed SNURs 
would need to certify their compliance with the SNUR requirements 
should these proposed rules be finalized. The EPA policy in support of 
import certification appears at 40 CFR part 707, subpart B. In 
addition, pursuant to 40 CFR 721.20, any persons who export or intend 
to export a chemical substance that is the subject of this proposed 
rule on or after October 11, 2019 are subject to the export 
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and 
must comply with the export notification requirements in 40 CFR part 
707, subpart D.

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

    1. Submitting CBI. Do not submit CBI 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 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.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at https://www.epa.gov/dockets/comments.html.

II. Background

A. What action is the Agency taking?

    EPA is proposing these SNURs under TSCA section 5(a)(2) for 6 
chemical substances which were the subjects of PMNs P-17-324, P-18-109, 
P-18-276, P-18-358, P-18-384, and P-19-24. These proposed SNURs would 
require persons who intend to manufacture or process any of these 
chemical substances for an activity that is designated as a significant 
new use to notify EPA at least 90 days before commencing that activity.
    The record for the proposed SNURs on these chemicals was 
established as docket EPA-HQ-OPPT-2019-0495. That record includes 
information considered by the Agency in developing these proposed 
SNURs.

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

    TSCA section 5(a)(2) (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 the four TSCA section 5(a)(2) factors 
listed in Unit III. Once EPA determines through rulemaking that a use 
of a chemical substance is a significant new use, TSCA section 
5(a)(1)(B)(i) (15 U.S.C. 2604(a)(1)(B)(i)) requires persons to submit a 
significant new use notice (SNUN) to EPA at least 90 days before they 
manufacture or process the chemical substance for that use. TSCA 
prohibits such manufacturing or processing from commencing until EPA 
has conducted a review of the SNUN, made an appropriate determination 
on the SNUN, and taken such actions as are required in association with 
that determination (15 U.S.C. 2604(a)(1)(B)(ii)). In the case of a 
determination other than not likely to present unreasonable risk, the 
applicable review period must also expire before manufacturing or 
processing for the new use may commence. As described in Unit V., the 
general SNUR provisions are found at 40 CFR part 721, subpart A.

C. Applicability of General Provisions

    General provisions for SNURs appear in 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 rule. 
Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 
Sec.  721.1(c), persons subject to these SNURs must comply with the 
same SNUN requirements and EPA regulatory procedures as submitters of 
PMNs under TSCA section 5(a)(1)(A) (15 U.S.C. 2604(a)(1)(A)). In 
particular, these requirements include the information submission 
requirements of TSCA sections 5(b) and 5(d)(1) (15 U.S.C. 2604(b) and 
2604(d)(1)), the exemptions authorized by TSCA sections 5(h)(1), 
5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720. 
Once

[[Page 47925]]

EPA receives a SNUN, EPA must either determine that the use is not 
likely to present an unreasonable risk of injury under the conditions 
of use for the chemical substance or take such regulatory action as is 
associated with an alternative determination before the manufacture or 
processing for the significant new use can commence. If EPA determines 
that the use is not likely to present an unreasonable risk, EPA is 
required under TSCA section 5(g) to make public, and submit for 
publication in the Federal Register, a statement of EPA's findings.

III. Significant New Use Determination

    TSCA section 5(a)(2) 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:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In determining what would constitute a significant new use for the 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, and 
potential human exposures and environmental releases that may be 
associated with the conditions of use of the substances, in the context 
of the four bulleted TSCA section 5(a)(2) factors listed in this unit. 
During its review of these chemicals, EPA identified certain conditions 
of use that are not intended by the submitters, but reasonably foreseen 
to occur. EPA is proposing to designate those reasonably foreseen 
conditions of use as significant new uses.

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for 6 chemical substances in 40 CFR part 721, subpart E. In this unit, 
EPA provides the following information for each chemical substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Basis for the SNUR.
     Information identified by EPA that would help characterize 
the potential health and/or environmental effects of the chemical 
substances if a manufacturer or processor is considering submitting a 
SNUN for a significant new use designated by the SNUR.
    This information may include testing not required to be conducted 
but which would help characterize the potential health and/or 
environmental effects of the PMN substance. Any recommendation for 
information identified by EPA was made based on EPA's consideration of 
available screening-level data, if any, as well as other available 
information on appropriate testing for the chemical substance. Further, 
any such testing identified by EPA that includes testing on vertebrates 
was made after consideration of available toxicity information, 
computational toxicology and bioinformatics, and high-throughput 
screening methods and their prediction models. EPA also recognizes that 
whether testing/further information is needed will depend on the 
specific exposure and use scenario in the SNUN. EPA encourages all SNUN 
submitters to contact EPA to discuss any potential future testing. See 
Unit VII. for more information.
     CFR citation assigned in the regulatory text section of 
these proposed rules.
    The regulatory text section of these proposed rules specifies the 
activities designated as significant new uses. Certain new uses, 
including production volume limits and other uses designated in the 
proposed rules, may be claimed as CBI.
    The chemical substances that are the subject of these proposed 
SNURs are undergoing premanufacture review. In addition to those 
conditions of use intended by the submitter, EPA has identified certain 
other reasonably foreseen conditions of use. EPA has preliminarily 
determined that the chemicals under their intended conditions of use 
are not likely to present an unreasonable risk. However, EPA has not 
assessed risks associated with the reasonably foreseen conditions of 
use for these chemicals. EPA is proposing to designate these reasonably 
foreseen and other potential conditions of use as significant new uses. 
As a result, those conditions of use are no longer reasonably foreseen 
to occur without first going through a separate, subsequent EPA review 
and determination process associated with a SNUN.
    The substances subject to these proposed rules are as follows:

PMN Number: P-17-324

    Chemical name: 2,4-Hexadien-1-ol, 1-acetate, (2E,4E)-
    CAS number: 57006-69-6.
    Basis for action: The PMN states that the use of the substance will 
be as a chemical intermediate. Based on the physical/chemical 
properties of the PMN substance and Structure Activity Relationships 
(SAR) analysis of test data on analogous substances, EPA has identified 
concerns for skin sensitization, specific target organ toxicity, skin 
and eye irritation, neurotoxicity, and aquatic toxicity if the chemical 
substance is used in ways other than as intended by the PMN submitter. 
Other conditions of use of the PMN substance that EPA intends to assess 
before they occur include the following:
    1. Use other than as a chemical intermediate; and
    2. Release of the PMN substance from manufacturing, processing, or 
use into the waters of the United States resulting in surface water 
concentrations that exceed 5 ppb.
    The proposed SNUR would designate as a ``significant new use'' 
these conditions of use.
    Potentially useful information: EPA has determined that certain 
information may be potentially useful to characterize the health and 
environmental effects of the PMN substance if a manufacturer or 
processor is considering submitting a SNUN for a significant new use 
that would be designated by this proposed SNUR. EPA has determined that 
the results of specific target organ toxicity, skin and eye irritation, 
skin sensitization, and aquatic toxicity testing would help 
characterize the potential health and environmental effects of the PMN 
substance.
    CFR citation: 40 CFR 721.11375.

PMN Number: P-18-109

    Chemical name: 2-alkenoic acid, 2-alkyl-, alkyl ester, polymer with 
2-(dialkylamino)alkyl 2-alkyl-2-alkenoate, alkyl 2-alkyl-2-alkenoate 
and a-(2-alkyl-1-oxo-2-alken-1-yl)-o-alkoxypoly(oxy-1,2-alkanediyl), 
[(1-alkoxy-2-alkyl-1-alken-1-yl)oxy]trialkylsilane-initiated (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an additive, open, non-
dispersive use. Based on the physical/chemical properties of the PMN 
substance and SAR analysis of test

[[Page 47926]]

data on analogous substances, EPA has identified concerns for lung 
toxicity and aquatic toxicity if the chemical substance is used in ways 
other than as intended by the PMN submitter. Other conditions of use of 
the PMN substance that EPA intends to assess before they occur include 
the following:
    1. No manufacturing, processing, or use of the PMN substance in a 
manner that results in inhalation exposures; and
    2. Release of the PMN substance from manufacturing, processing, or 
use into the waters of the United States resulting in surface water 
concentrations that exceed 14 ppb.
    The proposed SNUR would designate as a ``significant new use'' 
these conditions of use.
    Potentially useful information: EPA has determined that certain 
information may be potentially useful to characterize the health and 
environmental effects of the PMN substance if a manufacturer or 
processor is considering submitting a SNUN for a significant new use 
that would be designated by this proposed SNUR. EPA has determined that 
the results of specific target organ toxicity, pulmonary effects and 
aquatic toxicity testing would help characterize the potential health 
and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.11376.

PMN Number: P-18-276

    Chemical name: Benzenesulfonamide, N-[lsqb]2-
[lsqb][lsqb](phenylamino)carbony[rsqb][rsqb]amino[rsqb] 
pheny[rsqb][rsqb]-.
    CAS number: 215917-77-4.
    Basis for action: The PMN states that the use of the substance will 
be as a developer for thermal paper. Based on the physical/chemical 
properties of the PMN substance and SAR analysis of test data on 
analogous substances, EPA has identified concerns for systemic toxicity 
and immunotoxicity if the chemical substance is used in ways other than 
as intended by the PMN submitter. Other conditions of use of the PMN 
substance that EPA intends to assess before they occur include the 
following:
     Use other than as a developer for thermal paper.
    The proposed SNUR would designate as a ``significant new use'' this 
condition of use.
    Potentially useful information: EPA has determined that certain 
information may be potentially useful to characterize the health 
effects of the PMN substance if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this proposed SNUR. EPA has determined that the results 
of specific target organ toxicity testing would help characterize the 
potential health effects of the PMN substance.
    CFR citation: 40 CFR 721.11377.

PMN Number: P-18-358

    Chemical name: 1H-Imidazole-1-propanenitrile,2-ethyl-ar-methyl-.
    CAS number: 568591-00-4.
    Basis for action: The PMN states that the use of the substance will 
be as a curing agent (a) within carbon fiber reinforced plastics 
prepreg and (b) in industrial adhesives for electronics, both to 
expedite the harding process during the final thermosetting operation. 
Based on the physical/chemical properties of the PMN substance, test 
data on the PMN substance, and SAR analysis of test data on analogous 
substances, EPA has identified concerns for eye irritation, and liver, 
thyroid, and developmental toxicity if the chemical substance is used 
in ways other than as intended by the PMN submitter. Other conditions 
of use of the PMN substance that EPA intends to assess before they 
occur include the following:
    1. Use of the PMN substance for other than the uses described in 
the PMN; and
    2. Use involving an application method that generates a vapor, mist 
or aerosol.
    The proposed SNUR would designate as a ``significant new use'' 
these conditions of use.
    Potentially useful information: EPA has determined that certain 
information may be potentially useful to characterize the health 
effects of the PMN substance if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this proposed SNUR. EPA has determined that the results 
of eye irritation, developmental toxicity and specific target organ 
toxicity testing would help characterize the potential health effects 
of the PMN substance.
    CFR citation: 40 CFR 721.11378.

PMN Number: P-18-384

    Chemical name: Lithium, isotope of mass 6.
    CAS number: 14258-72-1.
    Basis for action: The PMN states that the use of the substance will 
be as a starting material for manufacture of 6-Lithium chloride 
scintillation crystals for use in radiation detection. Based on the 
physical/chemical properties of the PMN substance and SAR analysis of 
test data on analogous substances, EPA has identified concerns for 
corrosion and acute handling hazard, neurotoxicity, kidney, 
developmental and thyroid toxicity, and aquatic toxicity if the 
chemical substance is used in ways other than as intended by the PMN 
submitter. Other conditions of use of the PMN substance that EPA 
intends to assess before they occur include the following:
    1. Use other than as a starting material for manufacture of 6-
Lithium chloride scintillation crystals for use in radiation detection; 
and
    2. Release of the PMN substance from manufacturing, processing, or 
use into the waters of the United States resulting in surface water 
concentrations that exceed 8.5 ppb.
    The proposed SNUR would designate as a ``significant new use'' this 
condition of use.
    Potentially useful information: EPA has determined that certain 
information about workplace exposure to and aquatic toxicity of the PMN 
substance may be potentially useful if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this proposed SNUR. EPA has determined that the results 
of workplace air monitoring and aquatic toxicity testing would help 
characterize the potential health and environmental effects of the PMN 
substance.
    CFR citation: 40 CFR 721.11379.

PMN Number: P-19-24

    Chemical name: Silsesquioxanes, 3-(dimethyloctadecylammonio)propyl 
Me Pr, polymers with silicic acid (H4SiO4) tetra-Et ester, (2-
hydroxyethoxy)- and methoxy-terminated, chlorides.
    CAS number: 2231249-14-0.
    Basis for action: The PMN states that the use of the substance will 
be as an asphalt additive or asphalt emulsion additive. Based on the 
physical/chemical properties of the PMN substance and SAR analysis of 
test data on analogous substances, EPA has identified concerns for skin 
and eye irritation, kidney toxicity, lung toxicity, and aquatic 
toxicity if the chemical substance is used in ways other than as 
intended by the PMN submitter. Other conditions of use of the PMN 
substance that EPA intends to assess before they occur include the 
following:
    1. Use other than as an asphalt additive or asphalt emulsion 
additive;
    2. Use as an asphalt additive in a manner that results in 
inhalation exposure to respirable particles or droplets containing the 
PMN substance; and
    3. Release of the PMN substance from manufacturing, processing, or 
use into the waters of the United States resulting in surface water 
concentrations that exceed 8 ppb.
    The proposed SNUR would designate as a ``significant new use'' this 
condition of use.

[[Page 47927]]

    Potentially useful information: EPA has determined that certain 
information may be potentially useful to characterize the health and 
environmental effects of the PMN substance if a manufacturer or 
processor is considering submitting a SNUN for a significant new use 
that would be designated by this proposed SNUR. EPA has determined that 
the results of irritation, specific target organ toxicity, pulmonary 
effects, and aquatic toxicity testing would help characterize the 
potential health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.11380.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are the subject of these proposed SNURs and as further discussed 
in Unit IV, EPA identified certain other reasonably foreseen conditions 
of use, in addition to those conditions of use intended by the 
submitter. EPA has preliminarily determined that the chemical under the 
intended conditions of use is not likely to present an unreasonable 
risk. However, EPA has not assessed risks associated with the 
reasonably foreseen conditions of use. EPA is proposing to designate 
these conditions of use as significant new uses to ensure that they are 
no longer reasonably foreseen to occur without first going through a 
separate, subsequent EPA review and determination process associated 
with a SNUN.

B. Objectives

    EPA is proposing SNURs for 6 specific chemical substances which are 
undergoing premanufacture review because the Agency wants to achieve 
the following objectives with regard to the significant new uses that 
would be designated in this proposed rule:
     EPA would have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     EPA would be obligated to make a determination under TSCA 
section 5(a)(3) regarding the use described in the SNUN, under the 
conditions of use. The Agency will either determine under TSCA section 
5(a)(3)(C) that the significant new use is not likely to present an 
unreasonable risk, including an unreasonable risk to a potentially 
exposed or susceptible subpopulation identified as relevant by the 
Administrator under the conditions of use, or make a determination 
under TSCA section 5(a)(3)(A) or (B) and take the required regulatory 
action associated with the determination, before manufacture or 
processing for the significant new use of the chemical substance can 
occur.
     EPA would be able to complete its review and determination 
on each of the PMN substances, while deferring analysis on the 
significant new uses proposed in these rules unless and until the 
Agency receives a SNUN.
    Issuance of a proposed SNUR for a chemical substance does not 
signify that the chemical substance is listed on the TSCA Inventory. 
Guidance on how to determine if a chemical substance is on the TSCA 
Inventory is available on the internet at https://www.epa.gov/tsca-inventory.

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

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this proposed rule 
were undergoing premanufacture review at the time of signature of this 
proposed rule and were not on the TSCA Inventory. In cases where EPA 
has not received a notice of commencement (NOC) and the chemical 
substance has not been added to the TSCA Inventory, no person may 
commence such activities without first submitting a PMN. Therefore, for 
the chemical substances subject to these proposed SNURs, EPA concludes 
that the proposed significant new uses are not ongoing.
    EPA designates September 4, 2019 (the date of web posting) as the 
cutoff date for determining whether the new use is ongoing. The 
objective of EPA's approach is to ensure that a person cannot defeat a 
SNUR by initiating a significant new use before the effective date of 
the final rule.
    Persons who begin commercial manufacture or processing of the 
chemical substances for a significant new use identified on or after 
that date would have to cease any such activity upon the effective date 
of the final rule. To resume their activities, these persons would have 
to first comply with all applicable SNUR notification requirements and 
EPA would have to take action under TSCA section 5 allowing manufacture 
or processing to proceed. In developing this proposed rule, EPA has 
recognized that, given EPA's general practice of posting proposed rules 
on its website a week or more in advance of Federal Register 
publication, this objective could be thwarted even before Federal 
Register publication of the proposed rule.

VII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require development of 
any particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: If a person is required to 
submit information for a chemical substance pursuant to a rule, order 
or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA 
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information 
to be submitted to EPA at the time of submission of the SNUN.
    In the absence of a rule, order, or consent agreement under TSCA 
section 4 covering the chemical substance, persons are required only to 
submit information in their possession or control and to describe any 
other information known to or reasonably ascertainable by them (see 40 
CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. Unit IV. lists potentially 
useful information for all SNURs listed here. Descriptions are provided 
for informational purposes. The potentially useful information 
identified in Unit IV. will be useful to EPA's evaluation in the event 
that someone submits a SNUN for the significant new use. Companies who 
are considering submitting a SNUN are encouraged, but not required, to 
develop the information on the substance, which may assist with EPA's 
analysis of the SNUN.
    EPA strongly encourages persons, before performing any testing, to 
consult with the Agency pertaining to protocol selection. Furthermore, 
pursuant to TSCA section 4(h), which pertains to reduction of testing 
in vertebrate animals, EPA encourages consultation with the Agency on 
the use of alternative test methods and strategies (also called New 
Approach Methodologies, or NAMs), if available, to generate the 
recommended test data. EPA encourages dialog with Agency 
representatives to help determine how best the submitter can meet both 
the data needs and the objective of TSCA section 4(h).
    The potentially useful information described in Unit IV. may not be 
the only means of providing information to evaluate the chemical 
substance associated with the significant new uses. However, submitting 
a SNUN without any test data may increase the likelihood that EPA will 
take action under TSCA section 5(e) or 5(f). EPA recommends that 
potential SNUN

[[Page 47928]]

submitters contact EPA early enough so that they will be able to 
conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.

VIII. SNUN Submissions

    According to 40 CFR 721.1(c), persons submitting a SNUN must comply 
with the same notification 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 720.40 and 721.25. E-PMN software is available 
electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this proposed rule. EPA's complete economic 
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2019-0263.

X. Statutory and Executive Order Reviews

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

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

    This proposed rule would establish SNURs for 6 new chemical 
substances that were the subject of PMNs. The Office of Management and 
Budget (OMB) has exempted these types of actions from review under 
Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 
3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    According to the PRA, 44 U.S.C. 3501 et seq., 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 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.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated to average between 30 and 
170 hours per response. This burden estimate includes the time needed 
to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Regulatory Support Division, Office of Mission Support (2822T), 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001. Please remember to include the OMB control number in any 
correspondence, but do not submit any completed forms to this address.

C. Regulatory Flexibility Act (RFA)

    Pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), the Agency 
hereby certifies that promulgation of this proposed SNUR would not have 
a significant adverse economic impact on a substantial number of small 
entities. The requirement to submit a SNUN applies to any person 
(including small or large entities) who intends to engage in any 
activity described in the final rule as a ``significant new use.'' 
Because these uses are ``new,'' based on all information currently 
available to EPA, it appears that no small or large entities presently 
engage in such activities. A SNUR requires that any person who intends 
to engage in such activity in the future must first notify EPA by 
submitting a SNUN. Although some small entities may decide to pursue a 
significant new use 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 chemicals, 
the Agency receives only a small number of notices per year. For 
example, the number of SNUNs received was seven in Federal fiscal year 
(FY) 2013, 13 in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and 
11 in FY2018, only a fraction of these were from small businesses. In 
addition, the Agency currently offers relief to qualifying small 
businesses by reducing the SNUN submission fee from $16,000 to $2,800. 
This lower fee reduces the total reporting and recordkeeping of cost of 
submitting a SNUN to about $10,116 for qualifying small firms. 
Therefore, the potential economic impacts of complying with this 
proposed SNUR are not expected to be significant or adversely impact a 
substantial number of small entities. In a SNUR that published in the 
Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency 
presented its general determination that 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 reasons to believe that any 
State, local, or Tribal government will be impacted by this proposed 
rule. As such, EPA has determined that this proposed rule does not 
impose any enforceable duty, contain any unfunded mandate, or otherwise 
have any effect on small governments subject to the requirements of 
UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1531-1538 et seq.).

E. Executive Order 13132: Federalism

    This action would 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 would not have Tribal implications because it is 
not expected to have substantial direct effects on Indian Tribes. This 
proposed rule would not significantly nor uniquely affect the 
communities of Indian Tribal governments, nor does it involve or impose 
any requirements that affect Indian Tribes. Accordingly, the 
requirements of Executive Order 13175

[[Page 47929]]

(65 FR 67249, November 9, 2000), do not apply to this proposed rule.

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

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997), because this is not an economically significant 
regulatory action as defined by Executive Order 12866, and this action 
does not address environmental health or safety risks 
disproportionately affecting 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 and because this action is not a 
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this action does not involve any technical 
standards, NTTAA section 12(d), 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 action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898 (59 FR 
7629, February 16, 1994).

List of Subjects in 40 CFR Part 721

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

    Dated: August 30, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.

    Therefore, it is proposed that 40 CFR part 721 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. Sec.  721.11375 through 721.11380 to subpart E to read as 
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
721.11375 2,4 Hexadien-1-ol, 1-acetate, (2E,4E).
721.11376 2-Alkenoic acid, 2-alkyl-, alkyl ester, polymer with 2-
(dialkylamino)alkyl 2-alkyl-2-alkenoate, alkyl 2-alkyl-2-alkenoate 
and a-(2-alkyl-1-oxo-2-alken-1-yl)-o-alkoxypoly(oxy-1,2-alkanediyl), 
[(1-alkoxy-2-alkyl-1-alken-1-yl)oxy]trialkylsilane-initiated 
(generic).
721.11377 Benzenesulfonamide, N-[2-[[(phenylamino)carbonyl]amino] 
phenyl]-.
721.11378 1H-Imidazole-1-propanenitrile, 2-ethyl-ar-methyl-.
721.11379 Lithium, isotope of mass 6.
721.11380 Silsesquioxanes, 3-(dimethyloctadecylammonio)propyl Me Pr, 
polymers with silicic acid (H4SiO4) tetra-Et ester, (2-
hydroxyethoxy)- and methoxy-terminated, chlorides.
* * * * *

Subpart E--Significant New Uses for Specific Chemical Substances

* * * * *


Sec.  721.11375  2,4-Hexadien-1-ol, 1-acetate, (2E,4E)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2,4-hexadien-1-ol, 
1-acetate, (2E,4E)- (P-17-324, CASRN 57006-69-6) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g).
    (ii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) where N = 5.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11376  2-Alkenoic acid, 2-alkyl-, alkyl ester, polymer with 
2-(dialkylamino)alkyl 2-alkyl-2-alkenoate, alkyl 2-alkyl-2-alkenoate 
and a-(2-alkyl-1-oxo-2-alken-1-yl)-o-alkoxypoly(oxy-1,2-alkanediyl), 
[(1-alkoxy-2-alkyl-1-alken-1-yl)oxy]trialkylsilane-initiated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 2-
alkenoic acid, 2-alkyl-, alkyl ester, polymer with 2-
(dialkylamino)alkyl 2-alkyl-2-alkenoate, alkyl 2-alkyl-2-alkenoate and 
a-(2-alkyl-1-oxo-2-alken-1-yl)-o-alkoxypoly(oxy-1,2-alkanediyl), [(1-
alkoxy-2-alkyl-1-alken-1-yl)oxy]trialkylsilane-initiated (PMN P-18-109) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the chemical 
substance in a manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) where N = 14.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11377  Benzenesulfonamide, N-[2-
[[(phenylamino)carbonyl]amino]phenyl]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzenesulfonamide, 
N-[2-[[(phenylamino)carbonyl]amino]phenyl]-(P-18-276, CASRN 215917-77-
4) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a 
significant new use to use the chemical substance for other than as a 
developer for thermal paper.
    (ii) [Reserved].
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11378  1H-Imidazole-1-propanenitrile,2-ethyl-ar-methyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1H-imidazole-1-
propanenitrile,2-ethyl-

[[Page 47930]]

ar-methyl- (P-18-358, CASRN 568591-00-4) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (y)(1). It is a significant new use to use 
the chemical substance for other than as a curing agent within carbon 
fiber reinforced plastics prepreg or a curing agent in industrial 
adhesives for electronics.
    (ii) [Reserved].
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11379  Lithium, isotope of mass 6.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as lithium, isotope of 
mass 6 (P-18-384, CASRN 14258-72-1) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a 
significant new use to use the chemical substance for other than as a 
starting material for manufacture of 6-Lithium chloride scintillation 
crystals for use in radiation detection, including the engineering 
controls described in the PMN.
    (ii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) where N = 8.5.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11380  Silsesquioxanes, 3-(dimethyloctadecylammonio)propyl Me 
Pr, polymers with silicic acid (H4SiO4) tetra-Et ester, (2-
hydroxyethoxy)- and methoxy-terminated, chlorides.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as silsesquioxanes, 3-
(dimethyloctadecylammonio)propyl Me Pr, polymers with silicic acid 
(H4SiO4) tetra-Et ester, (2-hydroxyethoxy)- and methoxy-terminated, 
chlorides. (P-19-24, CASRN 2231249-14-0) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a 
significant new use to use the substance for other than as an asphalt 
additive or asphalt emulsion additive. It is a significant new use to 
use the chemical substance as an asphalt additive in a manner that 
results in inhalation exposure to respirable particles or droplets 
containing the chemical substance.
    (ii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) where N = 8.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2019-19579 Filed 9-10-19; 8:45 am]
 BILLING CODE 6560-50-P