Document ID: EPA-HQ-OPPT-2019-0263-0001
Agency: epa
Document Type: Proposed Rule
Title: Significant New Use Rules on Certain Chemical Substances (19-2.B)
Posted Date: 2019-06-11T04:00Z

[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Proposed Rules]
[Pages 27061-27069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12115]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2019-0263; FRL-9994-85]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances (19-2.B)

AGENCY: Environmental Protection Agency (EPA).

[[Page 27062]]

ACTION: Proposed rule.

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SUMMARY: EPA is proposing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for 8 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 8 
chemical substances for an activity that is designated as a significant 
new use by this proposed rule. If this proposed rule is made final, 
persons may 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, and has taken any actions as are required as a result of 
that determination.

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

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2019-0263, 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.
    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: 
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: moss.kenneth@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
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 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 July 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 http://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 8 
chemical substances which were the subjects of PMNs P-16-425, P-18-125, 
P-18-228, P-18-234, P-18-270, P-18-322, P-19-4, and P-19-34. 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-2019-0263. That record includes 
information considered by the Agency in developing these proposed 
SNURs.

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 the four bulleted TSCA section 5(a)(2) 
factors listed in Unit III. Once EPA determines 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)). 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

[[Page 27063]]

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 EPA receives a SNUN, EPA must 
either determine that the significant new use is not likely to present 
an unreasonable risk of injury 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 significant new 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

    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:
     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 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 significant new uses 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.

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for 8 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. EPA has initially 
determined under TSCA section 5(a)(2), 15 U.S.C. 2604(a)(2), that 
certain changes from the intended conditions of use described in the 
PMNs could result in changes in the type or form of exposure to the 
chemical substances and/or increased exposures to the chemical 
substances and/or changes in the reasonably anticipated manner and 
methods of manufacturing, processing, distribution in commerce, and 
disposal of the chemical substances. Consequently, EPA is proposing to 
designate these changes as significant new uses.

PMN Number: P-16-425

    Chemical name: Amino-silane (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical reactant used 
in manufacturing a polymer. 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 irritation, lung effects, developmental effects, 
neurotoxicity, liver effects and skin sensitization if the chemical 
substance is not used following the limitations noted. The conditions 
of use of the PMN substance as described in the PMN include the 
following protective measure:
    1. Use other than as a chemical intermediate.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance 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 or pulmonary effects, reproductive/developmental 
toxicity, neurotoxicity and skin sensitization testing would help 
characterize the potential health effects of the PMN substance.
    CFR citation: 40 CFR 721.11258.

PMN Number: P-18-125

    Chemical name: Oxoalkylcarboxylic acid, sodium salt (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a reagent in coating 
material. 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 kidney 
toxicity, eye, skin and lung irritation and developmental toxicity if 
the chemical

[[Page 27064]]

substance is not used following the limitations noted. The conditions 
of use of the PMN substance as described in the PMN include the 
following protective measures:
    1. No manufacture of the PMN substance in the United States (i.e., 
import only); and
    2. No use other than the confidential use described in the PMN.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance 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 irritation and 
sensitization testing would help characterize the potential health 
effects of the PMN substance.
    CFR citation: 40 CFR 721.11260.

PMN Number: P-18-228

    Chemical name: Branched alkenyl acid, alkyl ester, homopolymer 
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a tackifier. 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 eye irritation, 
neurotoxicity, systemic, blood, respiratory and cardiovascular effects 
and developmental toxicity if the chemical substance is not used 
following the limitations noted. The conditions of use of the PMN 
substance as described in the PMN include the following protective 
measures:
    1. No use other than the confidential use identified in the PMN; 
and
    2. No manufacture, processing or use of the PMN substance in any 
manner that results in inhalation exposures.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance 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, pulmonary effects, developmental toxicity, and 
neurotoxicity testing would help characterize the potential health 
effects of the PMN substance.
    CFR citation: 40 CFR 721.11261.

PMN Number: P-18-234

    Chemical name: Alkenoic acid, reaction products with bis 
substituted alkane and ether polyol (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a coating component. 
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 and eye 
irritation and sensitization if the chemical substance is not used 
following the limitations noted. The conditions of use of the PMN 
substance as described in the PMN include the following protective 
measure:
    1. No use of the PMN substance involving spray application that 
results in inhalation exposures.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance 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 skin irritation, 
eye damage and skin sensitization testing would help characterize the 
potential health effects of the PMN substance.
    CFR citation: 40 CFR 721.11262.

PMN Number: P-18-270

    Chemical name: Ethanol, 2-butoxy-, 1,1'-ester (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the uses of the substance 
will be as an active co-solvent for solvent-based coatings; a 
coalescent for industrial water-based coatings; a coupling agent and 
solvent in industrial cleaners, rust removers, hard surface cleaners 
and disinfectants; and a primary solvent in solvent-based silk screen 
printing inks. 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 
irritation, solvent neurotoxicity, immunotoxicity, and developmental, 
reproductive, liver and blood toxicity, if the chemical substance is 
not used following the limitations noted. The conditions of use of the 
PMN substance as described in the PMN include the following protective 
measures:
    1. No use of the PMN substance for other than the uses described in 
the PMN; and
    2. No use of the PMN substance in a consumer product.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance 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 toxicokinetics, 
specific target organ toxicity, skin irritation, and reproductive 
toxicity testing would help characterize the potential health effects 
of the PMN substance.
    CFR citation: 40 CFR 721.11263.

PMN Number: P-18-322

    Chemical name: Heteromonocycle, 4,6-dimethyl-2-(1-phenylethyl)- 
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a fragrance ingredient in 
consumer products. Based on the physical/chemical properties of the PMN 
substance and test data on the PMN substance, EPA has identified 
concerns for skin irritation and sensitization and gastrointestinal 
tract effects, liver and thyroid toxicity and blood effects if the 
chemical substance is not used following the limitations noted. The 
conditions of use of the PMN substance as described in the PMN include 
the following protective measures:
    1. No manufacture of the PMN substance in the United States (i.e., 
import only); and
    2. No processing (formulation) to a concentration of greater than 
5% of the PMN substance by weight.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance 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

[[Page 27065]]

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 721.11264.

PMN Number: P-19-4

    Chemical name: Aromatic dianhydride, polymer with aromatic diamine 
and heteroatom bridged aromatic diamine, reaction products with 
aromatic anhydride (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as molded parts and 
components. 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 lung 
overload if the chemical substance is not used following the 
limitations noted. The conditions of use of the PMN substance as 
described in the PMN include the following protective measure:
    1. No manufacture, processing or use of the PMN substance in any 
manner that results in inhalation exposures.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance 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 pulmonary effects 
testing would help characterize the potential health effects of the PMN 
substance.
    CFR citation: 40 CFR 721.11265.

PMN Number: P-19-34

    Chemical name: Metal, bis(2,4-pentanedionato-kO2,kO4)- (T-4)- 
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a contained use as a 
component of tires. 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 eye 
irritation, blood, liver, kidney, GI and reproductive/developmental 
effects, neurotoxicity, immunotoxicity, and genetic toxicity if the 
chemical substance is not used following the limitations noted. The 
conditions of use of the PMN substance as described in the PMN include 
the following protective measures:
    1. No manufacture of the PMN substance in the United States (i.e., 
import only); and
    2. No use other than the confidential use described in the PMN 
including the engineering controls for processing and use as described 
in the PMN.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance 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, reproductive/developmental toxicity, and neurotoxicity 
testing would help characterize the potential health effects of the PMN 
substance.
    CFR citation: 40 CFR 721.11266.

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 reasonably foreseen changes from the 
conditions of use identified in the PMNs and determined that those 
changes could result in changes in the type or form of exposure to the 
chemical substances and/or increased exposures to the chemical 
substances and/or changes in the reasonably anticipated manner and 
methods of manufacturing, processing, distribution in commerce, and 
disposal of the chemical substances.

B. Objectives

    EPA is proposing SNURs for 8 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 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 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.
    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 http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

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 June 6, 2019 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 section 5 allowing manufacture or 
processing to proceed.

[[Page 27066]]

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 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.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

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 8 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 section 605(b) of the RFA, 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

[[Page 27067]]

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 (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: May 31, 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.  721.11258 and 721.11260 through 721.11266 to subpart 
E to read as follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
721.11258 Amino-silane (generic).
721.11260 Oxoalkylcarboxylic acid, sodium salt (generic).
721.11261 Branched alkenyl acid, alkyl ester, homopolymer (generic).
721.11262 Alkenoic acid, reaction products with bis substituted 
alkane and ether polyol (generic).
721.11263 Ethanol, 2-butoxy-, 1,1'-ester (generic).
721.11264 Heteromonocycle, 4,6-dimethyl-2-(1-phenylethyl)- 
(generic).
721.11265 Aromatic dianhydride, polymer with aromatic diamine and 
heteroatom bridged aromatic diamine, reaction products with aromatic 
anhydride (generic).
721.11266 Metal, bis(2,4-pentanedionato-kO2,kO4)- (T-4)- (generic).

Subpart E--Significant New Uses for Specific Chemical Substances

Sec.  721.11258   Amino-silane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as amino-
silane (PMN P-16-425) 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) [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) though (c) and (i), are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11260   Oxoalkylcarboxylic acid, sodium salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
oxoalkylcarboxylic acid, sodium salt (P-18-125) 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(f) and (j).
    (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

[[Page 27068]]

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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

Sec.  721.11261   Branched alkenyl acid, alkyl ester, homopolymer 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
branched alkenyl acid, alkyl ester, homopolymer (P-18-228) 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(j). It is a significant new use to 
manufacture, process or use the substance in any manner that results in 
inhalation exposures.
    (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), (i), and (k) 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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

Sec.  721.11262   Alkenoic acid, reaction products with bis substituted 
alkane and ether polyol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkenoic acid, reaction products with bis substituted alkane and ether 
polyol (P-18-234) 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 involving spray application 
that results in inhalation exposures.
    (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), (i), (j) and (k) 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.  721.11263   Ethanol, 2-butoxy-, 1,1'-ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
ethanol, 2-butoxy-, 1,1'-ester (P-18-270) 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(o). It is a significant new use to use the 
substance for other than an active co-solvent for solvent-based 
coatings; a coalescent for industrial water-based coatings; a coupling 
agent and solvent for industrial cleaners, rust removers, hard surface 
cleaners and disinfectants; and a primary solvent in solvent-based silk 
screen printing inks.
    (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.  721.11264   Heteromonocycle, 4,6-dimethyl-2-(1-phenylethyl)- 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
heteromonocycle, 4,6-dimethyl-2-(1-phenylethyl)- (P-18-322) 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(f). It is a significant new use to process 
(formulate) the substance to a concentration of greater than 5% by 
weight.
    (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), (i), and (k) 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.  721.11265   Aromatic dianhydride, polymer with aromatic diamine 
and heteroatom bridged aromatic diamine, reaction products with 
aromatic anhydride (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
aromatic dianhydride, polymer with aromatic diamine and heteroatom 
bridged aromatic diamine, reaction products with aromatic anhydride (P-
19-4) 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 manufacture, process or use of the substance in 
any manner that results in inhalation exposures.
    (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.  721.11266   Metal, bis(2,4-pentanedionato-kO2,kO4)- (T-4)- 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as metal, 
bis(2,4-pentanedionato-kO2,kO4)- (T-4)- (P-19-34) 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(f) and (j). It is a significant new use to 
process or use the substance without the engineering controls described 
in the premanufacture notice.

[[Page 27069]]

    (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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

[FR Doc. 2019-12115 Filed 6-10-19; 8:45 am]
 BILLING CODE 6560-50-P