Significant New Use Rules on Certain Chemical Substances, 43527-43538 [2018-18534]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 83, Number 166 (Monday, August 27, 2018)]
[Rules and Regulations]
[Pages 43527-43538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18534]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2017-0560; FRL-9982-77]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is promulgating significant new use rules (SNURs) under 
the Toxic Substances Control Act (TSCA) for 10 chemical substances 
which were the subject of premanufacture notices (PMNs). The chemical 
substances are subject to Orders issued by EPA pursuant to section 5(e) 
of TSCA. This action requires persons who intend to manufacture 
(defined by statute to include import) or process any of these 10 
chemical substances for an activity that is designated as a significant 
new use by this rule to notify EPA at least 90 days before commencing 
that activity. The required notification initiates EPA's evaluation of 
the intended use within the applicable review period. Persons may not 
commence manufacture or processing for the significant new use until 
EPA has conducted a review of the notice, made an appropriate 
determination on the notice, and has taken such actions as are required 
with that determination.

DATES: This rule is effective on October 26, 2018. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
September 10, 2018.
    Written adverse comments on one or more of these SNURs must be 
received on or before September 26, 2018 (see Unit VI. of the 
SUPPLEMENTARY INFORMATION). If EPA receives written adverse commentsts, 
on one or more of these SNURs before September 26, 2018, EPA will 
withdraw the relevant sections of this direct final rule before its 
effective date.
    For additional information on related reporting requirement dates, 
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2017-0560, 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)

[[Page 43528]]

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, 
process, or use the chemical substances contained in this 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 SNURs must certify 
their compliance with the SNUR requirements. The EPA policy in support 
of import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export a chemical 
substance that is the subject of this rule on or after September 26, 
2018 are subject to the export notification provisions of TSCA section 
12(b) (15 U.S.C. 2611(b)) (see Sec.  721.20), 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 this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM 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?

    1. Direct Final Rule. EPA is promulgating these SNURs using direct 
final rule procedures. These SNURs will require persons to notify EPA 
at least 90 days before commencing the manufacture or processing of a 
chemical substance for any activity designated by these SNURs as a 
significant new use. Receipt of such notices obligates EPA to assess 
risks that may be associated with the significant new uses under the 
conditions of use and, if appropriate, to regulate the proposed uses 
before they occur.
    2. Proposed Rule. In addition to this direct final rule, elsewhere 
in this issue of the Federal Register, EPA is issuing a notice of 
proposed rulemaking for this rule. If EPA receives no adverse comment, 
the Agency will not take further action on the proposed rule and the 
direct final rule will become effective as provided in this action. If 
EPA receives adverse comment on one or more of SNURs in this action by 
September 11, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION), the 
Agency will publish in the Federal Register a timely withdrawal of the 
specific SNURs that the adverse comments pertain to, informing the 
public that the actions will not take effect. EPA would then address 
all adverse public comments in a response to comments document in a 
subsequent final rule, based on the proposed rule.

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) 
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 (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore 
prohibits such manufacturing or processing from commencing until EPA 
has conducted a review of the notice, made an appropriate determination 
on the notice, 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 appear at 40 CFR part 700. According 
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). In particular, these requirements 
include the information submission requirements of TSCA section 5(b) 
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), 
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA 
receives a SNUN, EPA 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

[[Page 43529]]

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 a significant new use for the 10 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, 
likely human exposures and environmental releases associated with 
possible uses, and the four bulleted TSCA section 5(a)(2) factors 
listed in this unit.

IV. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping 
requirements for 10 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 TSCA section 5(e) Order.
     Information identified by EPA that would help characterize 
the potential health and/or environmental effects of the chemical 
substance in support of a request by the PMN submitter to modify the 
Order, or if a manufacturer or processor is considering submitting a 
SNUN for a significant new use designated by the SNUR.
    This information may include testing required in a TSCA section 
5(e) Order to be conducted by the PMN submitter, as well as testing not 
required to be conducted but which would also 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 VIII. for more information.
     CFR citation assigned in the regulatory text section of 
this rule.
    The regulatory text sections of these rules specify the activities 
designated as significant new uses. Certain new uses, including 
exceedance of production volume limits (i.e., limits on manufacture 
volume) and other uses designated in this rule, may be claimed as CBI. 
Unit IX. discusses a procedure companies may use to ascertain whether a 
proposed use constitutes a significant new use.
    These rules include 10 PMN substances that are subject to Orders 
under TSCA section 5(e)(1)(A). Each Order is based on one or more of 
the findings in TSCA section 5(a)(3)(B): There is insufficient 
information to permit a reasoned evaluation; in the absence of 
sufficient information to permit a reasoned evaluation, the activities 
associated with the PMN substances may present unreasonable risk to 
human health or the environment; the substance is or will be produced 
in substantial quantities, and enters or may reasonably be anticipated 
to enter the environment in substantial quantities or there is or may 
be significant (substantial) human exposure to the substance. Those 
Orders require protective measures to limit exposures or otherwise 
mitigate the potential unreasonable risk. The SNURs identify as 
significant new uses any manufacturing, processing, use, distribution 
in commerce, or disposal that does not conform to the restrictions 
imposed by the underlying Orders, consistent with TSCA section 5(f)(4).
    Where EPA determines that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure, 
the underlying TSCA section 5(e) Order requires, among other things, 
that potentially exposed employees wear specified respirators unless 
actual measurements of the workplace air show that air-borne 
concentrations of the PMN substance are below a New Chemical Exposure 
Limit (NCEL) that is established by EPA to provide adequate protection 
to human health. In addition to the actual NCEL concentration, the 
comprehensive NCELs provisions in TSCA section 5(e) Orders, which are 
modeled after Occupational Safety and Health Administration (OSHA) 
Permissible Exposure Limits (PELs) provisions, include requirements 
addressing performance criteria for sampling and analytical methods, 
periodic monitoring, respiratory protection, and recordkeeping. 
However, no comparable NCEL provisions currently exist in 40 CFR part 
721, subpart B, for SNURs. Therefore, for these cases, the individual 
SNURs in 40 CFR part 721, subpart E, will state that persons subject to 
the SNUR who wish to pursue NCELs as an alternative to the Sec.  721.63 
respirator requirements may request to do so under Sec.  721.30. EPA 
expects that persons whose Sec.  721.30 requests to use the NCELs 
approach for SNURs that are approved by EPA will be required to comply 
with NCELs provisions that are comparable to those contained in the 
corresponding TSCA section 5(e) Order for the same chemical substance.

PMN Number: P-13-307

    Chemical name: Substituted carbocycle, N-[[[4-[[(4-substituted 
carbocyclic)amino]sulfonyl]carbocyclic]amino]carbonyl]-4-methyl-
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: July 31, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a component of 
manufactured consumer article--contained use. Based on SAR analysis of 
test data on analogous substances, EPA has identified concerns for 
systemic toxicity on the spleen, liver and thymus, blood effects, 
developmental toxicity and immunotoxicity. Based on SAR analysis for 
amides, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 5 parts per billion (ppb) in surface waters. 
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to

[[Page 43530]]

health and the environment. To protect against these risks, the Order 
requires:
    1. Submission of certain toxicity testing prior to exceeding the 
confidential production volume limit specified in the Order;
    2. Use of personal protective equipment, including impervious 
gloves, to prevent dermal exposure;
    3. Use of NIOSH certified respirators with Assigned Protection 
Factor (APF) of 10 to prevent inhalation exposures or compliance with a 
NCEL of 4 mg/m\3\ as an 8-hour time-weighted average to prevent 
inhalation exposure;
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the Safety Data Sheet (SDS);
    5. Refraining from manufacturing the PMN substance in the United 
States (i.e., import only);
    6. Use of the PMN substance only for the confidential use specified 
in the Order; and
    7. No release of the PMN substances resulting in surface water 
concentrations that exceed 30 ppb.
    The SNUR designates 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 substances may 
be potentially useful to characterize the effects of the PMN substances 
in support of a request by the PMN submitter to modify the Order, or if 
a manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. The submitter 
has agreed not to exceed a certain production volume limit without 
performing specific organ toxicity testing.
    CFR citation: 40 CFR 721.11116.

PMN Numbers: P-16-316 and P-16-317

    Chemical name: Aliphatic polyester (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: July 27, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances will be as drilling chemicals. 
Based on SAR analysis of test data on analogous substances, EPA has 
identified concerns for kidney toxicity. The Order was issued under 
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substances may present an unreasonable risk of 
injury to health and the environment. To protect against these risks, 
the Order requires:
    1. Use of the PMN substances only for the confidential use 
specified in the Order; and
    2. Manufacture (which under TSCA includes import) the PMN 
substances with a average molecular weight no lower than 22,000 for P-
16-0316 and no lower than 14,000 for P-16-0317 and species with a 
molecular weight less than 500 present at a maximum of 2% by weight.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the fate, environmental toxicity and human health 
toxicity of the PMN substances may be potentially useful to 
characterize the effects of the PMN substances in support of a request 
by the PMN submitter to modify the Order, or if a manufacturer or 
processor is considering submitting a SNUN for a significant new use 
that will be designated by this SNUR. EPA has determined that the 
results of water solubility and log Kow testing, acute and chronic 
aquatic toxicity testing and developmental toxicity testing may be 
potentially useful in characterizing the health and environmental 
effects of the PMN substances. Although the Order does not require 
these tests, the Order's restrictions will remain in effect until the 
Order is modified or revoked by EPA based on submission of this or 
other relevant information.
    CFR citations: 40 CFR 721.11117.

PMN Number: P-16-342

    Chemical name: Modified acrylic polymer (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: August 7, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a dispersant for 
deflocculation of pigments in industrial paints and coatings. Based on 
SAR analysis of test data on analogous substances, EPA has identified 
concerns for lung toxicity. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to health and the 
environment. To protect against these risks, the Order requires:
    1. Refrain from manufacturing the PMN substance in the United 
States (i.e., import only);
    2. Use of the PMN substance only as a dispersant for deflocculation 
of pigments in industrial paints and coatings;
    3. Use the PMN substance in the paint/coating formulation at a 
concentration not greater than 1 percent by weight or volume;
    4. No modification of the processing method or use activities of 
the PMN substance that would allow inhalation exposure to the PMN 
substance by vapor, dust, mist or aerosols at concentrations greater 
than 1 percent by weight or volume; and
    5. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the (SDS).
    The SNUR designates 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 substances may 
be potentially useful to characterize the effects of the PMN substances 
in support of a request by the PMN submitter to modify the Order, or if 
a manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. EPA has 
determined that the results of pulmonary toxicity testing may be 
potentially useful in characterizing the health effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions will remain in effect until the Order is modified or 
revoked by EPA based on submission of this or other relevant 
information.
    CFR citation: 40 CFR 721.11118.

PMN Numbers: P-16-406 and P-16-407

    Chemical names: Functionalized polyimide (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: July 27, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances will be as coating for solid 
substrates. Based on SAR analysis of test data on analogous substances, 
EPA has identified concerns for lung toxicity. The Order was issued 
under TSCA sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a finding 
that the information available to the Agency is insufficient to permit 
a reasoned evaluation of the human health effects. To protect against 
any potential risks the Order requires:
    1. Use of the PMN substances only as a coating for solid 
substrates;
    2. No use of the PMN substances involving application methods that

[[Page 43531]]

generate inhalation exposures to the PMN substance by vapor, dust, mist 
or aerosols; and
    3. No modification of manufacturing process of the PMN substances 
such that workers would be exposed through inhalation.
    The SNUR designates 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 substances may 
be potentially useful to characterize the effects of the PMN substances 
in support of a request by the PMN submitter to modify the Order, or if 
a manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. EPA has 
determined that the results of pulmonary toxicity testing may be 
potentially useful in characterizing the health effects of the PMN 
substances. Although the Order does not require these tests, the 
Order's restrictions will remain in effect until the Order is modified 
or revoked by EPA based on submission of this or other relevant 
information.
    CFR citation: 40 CFR 721.11119.

PMN Number: P-16-413

    Chemical name: Siloxanes and Silicones, di-Me, 3-hydroxypropyl Me, 
Me 3,3,4,4,5,5,6,6,6-nonafluorohexyl.
    CAS number: 1610862-54-8.
    Effective date of TSCA section 5(e) Order: July 13, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the PMN substance is as an anti-fingerprint material for a metal 
coating application. Based on SAR analysis of test data on analogous 
substances, EPA has identified concerns for lung toxicity based on 
waterproofing of the lung if inhaled. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
health and the environment. To protect against these risks, the Order 
requires:
    1. Submission of certain fate testing on the PMN substance prior to 
exceeding the production volume limits specified in the Order;
    2. No processing or use of the PMN substance in a manner that 
results in inhalation exposure due to spray, mist or aerosol;
    3. Refraining from manufacturing the PMN substance in the United 
States (i.e., import only); and
    4. No release of the PMN substance into the waters of the United 
States.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the fate and human health toxicity of the PMN 
substance may be potentially useful to characterize the effects of the 
PMN substance in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that will be designated by this SNUR. 
The submitter has agreed not to exceed the confidential production 
limit without performing a UV/visible absorption test, a direct and 
indirect photolysis test, aerobic and anaerobic transformation in soil 
test and aerobic and anaerobic transformation in sediment test. In 
addition, EPA has determined that the results of pulmonary toxicity 
testing may be potentially useful in characterizing the human health 
effects of the PMN substance. Although the Order does not require these 
tests, the Order's restrictions will remain in effect until the Order 
is modified or revoked by EPA based on submission of this or other 
relevant information.
    CFR citation: 40 CFR 721.11120.

PMN Number: P-16-455

    Chemical name: Sodium Tungsten Oxide.
    CAS number: 11120-01-7.
    Effective date of TSCA section 5(e) Order: November 2, 2016.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the PMN substance will be as a component of infrared absorption 
material. Based on test data on an analog, EPA has identified concerns 
for lung toxicity and carcinogenicity. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
health and the environment. EPA assessed risks based on the disposal 
processes and engineering controls described in the PMN. To protect 
against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit specified 
in the Order;
    2. Use of personal protective equipment, including impervious 
gloves, to prevent dermal exposure;
    3. Use of NIOSH certified respirators with a minimum (APF) of 1000 
to prevent inhalation exposure or compliance with a NCEL of 0.3 mg/m\3\ 
as an 8-hour time-weighted average to prevent inhalation exposure;
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the (SDS);
    5. Use of the PMN substance only as a component of infrared 
absorption material;
    6. No use of the PMN substance involving application methods that 
generate dust, mist or aerosol unless such application method occurs 
within an enclosed process;
    7. No release of the PMN substance into the waters of the United 
States; and
    8. The PMN substance and any waste streams from manufacture, 
processing, and use containing the PMN substance must be disposed of 
only by incineration or landfill.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and environmental toxicity of the 
PMN substance may be potentially useful to characterize the effects of 
the PMN substance in support of a request by the PMN submitter to 
modify the Order, or if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that will be designated by 
this SNUR. The submitter has agreed not to exceed the confidential 
production limit without performing specific pulmonary toxicity and 
carcinogenicity testing. In addition, EPA has determined that the 
results of certain chronic aquatic toxicity testing may be potentially 
useful in characterizing the environmental effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions will remain in effect until the Order is modified or 
revoked by EPA based on submission of this or other relevant 
information.
    CFR citation: 40 CFR 721.11121.

PMN Number: P-16-503

    Chemical name: Fatty acids, tall-oil, polymers with alkanoic acid, 
substituted carbomonocycle, alkyl peroxide-initiated (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: January 11, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the non-
confidential use of the PMN substance will be as a site-limited polymer 
intermediate for production of a deck stain coating resin additive. 
Based on physical-chemical properties of the PMN substance, EPA 
identified low

[[Page 43532]]

concerns for human health and environmental effects. However if the PMN 
substance were manufactured differently, EPA identified concerns for 
developmental toxicity and aquatic toxicity. The Order was issued under 
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substance may present an unreasonable risk of 
injury to health and the environment. To protect against these risks, 
the Order requires:
    1. Manufacture (including import) the PMN substance with a number 
average molecular weight no lower than 1500, and no more than 24% by 
weight of acid monomer in the polymer; and
    2. Use of the PMN substance only as an intermediate
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the fate, human health and environmental toxicity of 
the PMN substance may be potentially useful to characterize the effects 
of the PMN substance in support of a request by the PMN submitter to 
modify the Order, or if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that will be designated by 
this SNUR. EPA has determined that the results of physical-chemical 
property testing, chronic aquatic toxicity testing, and developmental 
toxicity testing may be potentially useful in characterizing the health 
and environmental effects of the PMN substance. Although the Order does 
not require these tests, the Order's restrictions will remain in effect 
until the Order is modified or revoked by EPA based on submission of 
this or other relevant information.
    CFR citation: 40 CFR 721.11122.

PMN Number: P-16-570

    Chemical name: Carboxylic acids, C6-18 and C8-15-di, polymers with 
diethylene glycol, glycerol, oleic acid, phthalic acid and sorbitol.
    CAS number: 1877295-51-6.
    Effective date of TSCA section 5(e) Order: August 5, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the PMN substance will be as an aromatic polyester polyol for 
manufacturing rigid foam. Based on test data on an analog, EPA has 
identified concerns for reproductive and developmental toxicity. Based 
on SAR analysis for esters, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 610 parts per billion (ppb). 
The Order was issued under TSCA sections 5(a)(3)(B)(i) and 
5(e)(1)(A)(i), based on a determination that ``the information 
available is insufficient to permit a reasoned evaluation of the human 
health effects and the PMN substance, ``stating that ``because of the 
absence of sufficient information to permit EPA to make such a 
determination and in light of the potential risk of human health 
effects posed by the uncontrolled manufacture (which includes import), 
processing, distribution in commerce, use and disposal of the PMN 
substance. EPA has concluded that uncontrolled manufacture, processing, 
distribution in commerce use, and disposal of the PMN substance may 
present an unreasonable risk of injury to human health.'' To protect 
against these risks, the Order requires:
    1. Submission of certain toxicity testing prior to exceeding the 
confidential production volume limit specified in the Order;
    2. Use of personal protective equipment to prevent dermal 
exposures;
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the (SDS);
    4. Manufacture (including import) the PMN substance with residual 
phthalate not greater than 0.1% by weight;
    5. Use of the PMN substance only as an aromatic polyester polyol 
for rigid foam;
    6. No modification of manufacturing, processing or use activities 
of the PMN substance to result in the generation of a vapor, mist or 
aerosol; and
    7. No release of the PMN substance into the waters of the United 
States.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the environmental and human health toxicity of the 
PMN substance may be potentially useful to characterize the effects of 
the PMN substance in support of a request by the PMN submitter to 
modify the Order, or if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that will be designated by 
this SNUR. The submitter has agreed not to exceed the confidential 
production limit without performing specific reproductive/developmental 
toxicity testing. In addition, EPA has determined that the results of 
acute aquatic toxicity testing may be potentially useful in 
characterizing the environmental effects of the PMN substance. Although 
the Order does not require these tests, the Order's restrictions will 
remain in effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
    CFR citation: 40 CFR 721.11123.

V. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are subject to these SNURs, EPA concluded that for all 10 chemical 
substances, regulation was warranted under TSCA section 5(e), pending 
the development of information sufficient to make reasoned evaluations 
of the health or environmental effects of the chemical substances. The 
basis for such findings is outlined in Unit IV. Based on these 
findings, TSCA section 5(e) Orders requiring the use of appropriate 
exposure controls were negotiated with the PMN submitters.
    The SNURs identify as significant new uses any manufacturing, 
processing, use, distribution in commerce, or disposal that does not 
conform to the restrictions imposed by the underlying Orders, 
consistent with TSCA section 5(f)(4).

B. Objectives

    EPA is issuing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this rule:
     EPA will receive notice of any person's intent to 
manufacture or process a listed chemical substance for the described 
significant new use before that activity begins.
     EPA will 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 will be able to either determine that the prospective 
manufacture or processing is not likely to present an unreasonable 
risk, or to take necessary regulatory action associated with any other 
determination, before the described significant new use of the chemical 
substance occurs.
     EPA will identify as significant new uses any 
manufacturing, processing, distribution in commerce, use, or disposal 
that does not conform to the restrictions imposed by the underlying 
Orders, consistent with TSCA section 5(f)(4).
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the

[[Page 43533]]

TSCA Chemical Substance Inventory (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/opptintr/existingchemicals/pubs/tscainventory/.

VI. Direct Final Procedures

    EPA is issuing these SNURs as a direct final rule. The effective 
date of this rule is October 26, 2018 without further notice, unless 
EPA receives written adverse comments before September 26, 2018.
    If EPA receives written adverse comments on one or more of these 
SNURs before September 26, 2018, EPA will withdraw the relevant 
sections of this direct final rule before its effective date.
    This rule establishes SNURs for a number of chemical substances. 
Any person who submits adverse comments must identify the chemical 
substance and the new use to which it applies. EPA will not withdraw a 
SNUR for a chemical substance not identified in the comment.

VII. Applicability of the Significant New Use Designation

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this rule have 
undergone premanufacture review. 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 chemical substances for 
which an NOC has not been submitted EPA concludes that the designated 
significant new uses are not ongoing.
    When chemical substances identified in this rule are added to the 
TSCA Inventory, EPA recognizes that, before the rule is effective, 
other persons might engage in a use that has been identified as a 
significant new use. However, TSCA section 5(e) Orders have been issued 
for all of the chemical substances, and the PMN submitters are 
prohibited by the TSCA section 5(e) Orders from undertaking activities 
which will be designated as significant new uses. The identities of 7 
of the 10 chemical substances subject to this rule have been claimed as 
confidential and EPA has received no post-PMN bona fide submissions 
(per Sec. Sec.  720.25 and 721.11) for a chemical substance covered by 
this action. Based on this, the Agency believes that it is highly 
unlikely that any of the significant new uses described in the 
regulatory text of this rule are ongoing.
    Therefore, EPA designates August 27, 2018 as the cutoff date for 
determining whether the new use is ongoing. The objective of EPA's 
approach has been to ensure that a person could not defeat a SNUR by 
initiating a significant new use before the effective date of the 
direct final rule.
    Persons who begin commercial manufacture or processing of the 
chemical substances for a significant new use identified as of that 
date will have to cease any such activity upon the effective date of 
the final rule. To resume their activities, these persons will have to 
first comply with all applicable SNUR notification requirements and 
wait until EPA has conducted a review of the notice, made an 
appropriate determination on the notice, and has taken such actions as 
are required with that determination.

VIII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: development of test data 
is required where the chemical substance subject to the SNUR is also 
subject to a rule, order or consent agreement under TSCA section 4 (see 
TSCA section 5(b)(1)).
    In the absence of a TSCA section 4 test rule 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 required or recommended testing for 
all of the listed SNURs. Descriptions of this information are provided 
for informational purposes. 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). To 
access the OCSPP test guidelines referenced in this document 
electronically, please go to https://www.epa.gov/ocspp and select ``Test 
Methods and Guidelines.'' The Organisation for Economic Co-operation 
and Development (OECD) test guidelines are available from the OECD 
Bookshop at https://www.oecdbookshop.org or SourceOECD at https://www.sourceoecd.org.
    In certain of the TSCA section 5(e) Orders for the chemical 
substances regulated under this rule, EPA has established production 
volume limits in view of the lack of data on the potential health and 
environmental risks that may be posed by the significant new uses or 
increased exposure to the chemical substances. These limits cannot be 
exceeded unless the PMN submitter first submits the results of toxicity 
tests that would permit a reasoned evaluation of the potential risks 
posed by these chemical substances. Under recent TSCA section 5(e) 
Orders, each PMN submitter is required to submit each study at least 14 
weeks (earlier TSCA section 5(e) Orders required submissions at least 
12 weeks) before reaching the specified production limit. Listings of 
the tests specified in the TSCA section 5(e) Orders are included in 
Unit IV. The SNURs contain the same production volume limits as the 
TSCA section 5(e) Orders. Exceeding these production limits is defined 
as a significant new use. Persons who intend to exceed the production 
limit must notify the Agency by submitting a SNUN at least 90 days in 
advance of commencement of non-exempt commercial manufacture or 
processing.
    Any request by EPA for the triggered and pended testing described 
in the Orders 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 PMN substances. Further, any such testing 
request on the part of 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.
    The potentially useful information identified in Unit IV. may not 
be the only means of addressing the potential risks of the chemical 
substance. However, submitting a SNUN without any test data may 
increase the likelihood that EPA will take action under TSCA section 
5(e), particularly if satisfactory test results have not been obtained 
from a prior PMN or SNUN submitter. EPA recommends that potential SNUN 
submitters contact EPA

[[Page 43534]]

early enough so that they will be able to generate useful information.
    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.

IX. Procedural Determinations

    By this rule, EPA is establishing certain significant new uses 
which have been claimed as CBI subject to Agency confidentiality 
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a 
final determination or other disposition of the confidentiality claim 
under 40 CFR part 2 procedures, EPA is required to keep this 
information confidential. EPA promulgated a procedure to deal with the 
situation where a specific significant new use is CBI, at Sec.  
721.1725(b)(1).
    Under these procedures a manufacturer or processor may request EPA 
to determine whether a proposed use would be a significant new use 
under the rule. The manufacturer or processor must show that it has a 
bona fide intent to manufacture or process the chemical substance and 
must identify the specific use for which it intends to manufacture or 
process the chemical substance. If EPA concludes that the person has 
shown a bona fide intent to manufacture or process the chemical 
substance, EPA will tell the person whether the use identified in the 
bona fide submission would be a significant new use under the rule. 
Since most of the chemical identities of the chemical substances 
subject to these SNURs are also CBI, manufacturers and processors can 
combine the bona fide submission under the procedure in Sec.  
721.1725(b)(1) with that under Sec.  721.11 into a single step.
    If EPA determines that the use identified in the bona fide 
submission would not be a significant new use, i.e., the use does not 
meet the criteria specified in the rule for a significant new use, that 
person can manufacture or process the chemical substance so long as the 
significant new use trigger is not met. In the case of a production 
volume trigger, this means that the aggregate annual production volume 
does not exceed that identified in the bona fide submission to EPA. 
Because of confidentiality concerns, EPA does not typically disclose 
the actual production volume that constitutes the use trigger. Thus, if 
the person later intends to exceed that volume, a new bona fide 
submission would be necessary to determine whether that higher volume 
would be a significant new use.

X. SNUN Submissions

    According to Sec.  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/opptintr/newchems.

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this rule. EPA's complete economic analysis is 
available in the docket under docket ID number EPA-HQ-OPPT-2017-0560.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

    This action establishes SNURs for several new chemical substances 
that were the subject of PMNs and TSCA section 5(e) Orders. The Office 
of Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act (PRA)

    According to 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. EPA is amending the table in 40 CFR part 9 to list the OMB 
approval number for the information collection requirements contained 
in this action. This listing of the OMB control numbers and their 
subsequent codification in the CFR satisfies the display requirements 
of PRA and OMB's implementing regulations at 5 CFR part 1320. This 
Information Collection Request (ICR) was previously subject to public 
notice and comment prior to OMB approval, and given the technical 
nature of the table, EPA finds that further notice and comment to amend 
it is unnecessary. As a result, EPA finds that there is ``good cause'' 
under section 553(b)(3)(B) of the Administrative Procedure Act (5 
U.S.C. 553(b)(3)(B)) to amend this table without further notice and 
comment.
    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, 
Collection Strategies Division, Office of Environmental Information 
(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)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) 
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a 
significant economic impact on a substantial number of small entities 
where the following are true:
    1. A significant number of SNUNs would not be submitted by small 
entities in response to the SNUR.
    2. The SNUR submitted by any small entity would not cost 
significantly more than $8,300.
    A copy of that certification is available in the docket for this 
action.
    This action is within the scope of the February 18, 2012 
certification. Based on the Economic Analysis discussed in Unit XI. and 
EPA's experience promulgating SNURs (discussed in the certification), 
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by 
small entities in response to the SNUR.

[[Page 43535]]

     Submission of the SNUN would not cost any small entity 
significantly more than $8,300.
    Therefore, the promulgation of the SNUR would not have a 
significant economic impact on a substantial number of small entities.

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 action. As 
such, EPA has determined that this action 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. 1501 et seq.).

E. Executive Order 13132

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

F. Executive Order 13175

    This action does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This 
action does 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, entitled ``Consultation and Coordination with 
Indian Tribal Governments'' (65 FR 67249, November 9, 2000), do not 
apply to this action.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (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

    This action is not subject to Executive Order 13211, entitled 
``Actions Concerning Regulations That Significantly Affect Energy 
Supply, Distribution, or Use'' (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

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898, entitled 
``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations'' (59 FR 7629, February 16, 
1994).

XIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: August 20, 2018.
Jeffery T. Morris,
Director, Office of Pollution Prevention and Toxics.

    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 
9601-9657, 11023, 11048.


0
2. In Sec.  9.1, add the following sections in numerical order under 
the undesignated center heading ``Significant New Uses of Chemical 
Substances'' to read as follows:


Sec.  9.1 OMB  approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                           OMB  control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.11116...............................................       2070-0012
721.11117...............................................       2070-0012
721.11118...............................................       2070-0012
721.11119...............................................       2070-0012
721.11120...............................................       2070-0012
721.11121...............................................       2070-0012
721.11122...............................................       2070-0012
721.11123...............................................       2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

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

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

0
4. Add Sec.  721.11116 to subpart E to read as follows:


Sec.  721.11116  Substituted carbocycle, N-[[[4-[[(4-substituted 
carbocyclic)amino]sulfonyl]carbocyclic]amino]carbonyl]-4-methyl- 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as substituted 
carbocycle, N-[[[4-[[(4-substituted 
carbocyclic)amino]sulfonyl]carbocyclic]amino]carbonyl]-4-methyl- (PMN 
P-13-307) 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) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4) (when determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (4), engineering control measures (e.g., enclosure or confinement 
of the operation, general and local ventilation) or administrative 
control measures (e.g., workplace policies and procedures) shall be 
considered and implemented to

[[Page 43536]]

prevent exposure, where feasible), (a)(5)(respirators must provide a 
National Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor of at least 10 or maintain workplace airborne 
concentrations), (a)(6)(particulate), (b)(concentrations set at 1.0%) 
and (c).
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) Order for this substance. The NCEL is 4 mg/m\3\ as an 
8-hour time weighted average. Persons who wish to pursue NCELs as an 
alternative to Sec.  721.63 respirator requirements may request to do 
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the 
NCELs approach are approved by EPA will be required to follow NCELs 
provisions comparable to those contained in the corresponding TSCA 
section 5(e) Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a), (b), (c), (d), (e)(concentration set at 1.0%), (f), 
(g)(1)(iv), (viii), (ix), (g)(2)(ii), (iii), (use respiratory 
protection or maintain workplace airborne concentrations below an 8-
hour time-weighted average of 4 mg/m\3\), (g)(2)(v), (g)(4)(i), (ii) 
and (g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System (GHS) and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k) and (q).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 30 ppb.
    (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), (i) and (k).
    (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)(iii) 
of this section.

0
5. Add Sec.  721.11117 to subpart E to read as follows:


Sec.  721.11117  Aliphatic polyester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
aliphatic polyester (PMNs P-16-316 and P-16-317) are 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(k). It is a significant new use to 
manufacture the PMN substances with an average molecular weight lower 
than 22,000 daltons for P16-316 and lower than 14,000 daltons for P-16-
317 and containing more than 2% by weight of molecular weight species 
less than 500 daltons.
    (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 and 
processors of these substances.
    (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.

0
6. Add Sec.  721.11118 to subpart E to read as follows:


Sec.  721.11118  Modified acrylic polymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
modified acrylic polymer (PMN P-16-342) 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) Hazard communication. Requirements as specified in Sec.  
721.72(a), (b), (c), (d), (e)(concentration set at 1.0%), (f), 
(g)(1)(ii), (g)(2)(ii), and (g)(5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System 
(GHS) and OSHA Hazard Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use for any 
use other than as a dispersant for deflocculation of pigments in 
industrial paints and coatings, any use in the paint/coating 
formulation at concentration greater than 1 percent by weight or 
volume, and any use of the substance that would allow inhalation 
exposure to the substance by vapor, dust, mist or aerosols at 
concentrations greater than 1 percent by weight or volume.
    (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), (b), (c), (f), (g), (h), 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.

0
7. Add Sec.  721.11119 to subpart E to read as follows:


Sec.  721.11119  Functionalized polyimide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified as functionalized 
polyimide (PMN P-16-406 and P-16-407) are 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) and (2). It is a significant new use 
to use the substances other than as a coating for solid substrates. Any 
manufacturing process that results in inhalation exposure to the 
substances is a significant new use.
    (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 and 
processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
8. Add Sec.  721.11120 to subpart E to read as follows:


Sec.  721.11120  Siloxanes and Silicones, di-Me, 3-hydroxypropyl Me, Me 
3,3,4,4,5,5,6,6,6-nonafluorohexyl.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as siloxanes and 
silicones, di-Me, 3-hydroxypropyl Me, Me 3,3,4,4,5,5,6,6,6-
nonafluorohexyl (CAS: 1610862-54-8) (PMN P-16-413) 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:

[[Page 43537]]

    (i) Industrial, commercial, and consumer activities. Requirements 
are described in Sec.  721.80(f) and (p)(40,000 kilograms and 151,300 
kilograms). It is a significant new use to process or use the PMN 
substance in a manner that results in inhalation exposure to spray, 
mist or aerosol.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (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 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
9. Add Sec.  721.11121 to subpart E to read as follows:


Sec.  721.11121  Sodium tungsten oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as sodium tungsten 
oxide (CAS No. 11120-01-7) (PMN P-16-455) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this section do not apply to 
quantities of the PMN substance after they have been incorporated into 
a polymer matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4)(when determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (4), engineering control measures (e.g., enclosure or confinement 
of the operation, general and local ventilation) or administrative 
control measures (e.g., workplace policies and procedures) shall be 
considered and implemented to prevent exposure, where feasible), 
(a)(5)(respirators must provide a National Institute for Occupational 
Safety and Health (NIOSH) assigned protection factor of at least 1000, 
(a)(6)(particulate), (b)(concentrations set at 0.1%) and (c).
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) Order for this substance. The NCEL is 0.3 mg/m\3\ as 
an 8-hour time weighted average. Persons who wish to pursue NCELs as an 
alternative to Sec.  721.63 respirator requirements may request to do 
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the 
NCELs approach are approved by EPA will be required to follow NCELs 
provisions comparable to those contained in the corresponding TSCA 
section 5(e) Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a), (b), (c), (d), (e)(concentration set at 0.1%), (f), 
(g)(1)(lung effects), (g)(1)(vii), (g)(2)(ii), (iii), (g)(2)(use 
respiratory protection or maintain workplace airborne concentrations 
below an 8-hour time-weighted average of 0.3 mg/m\3\), (g)(3)(ii), 
(g)(4)(i), (iii) and (g)(5). Alternative hazard and warning statements 
that meet the criteria of the Globally Harmonized System (GHS) and OSHA 
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q). It is a significant new to use the 
substance other than as a component of infrared absorption material. It 
is a significant new use to use involving an application method that 
generates a dust, mist, or aerosol, unless the application method 
occurs within an enclosed process.
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(2), (b)(1), (2), (c)(1), and (2).
    (v) Release to water. Requirements as specific in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (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 (k) 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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
10. Add Sec.  [emsp14]721.11122 to subpart E to read as follows:


Sec.  [emsp14]721.11122  Fatty acids, tall-oil, polymers with alkanoic 
acid, substituted carbomonocycle, alkyl peroxide-initiated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as fatty 
acids, tall-oil, polymers with alkanoic acid, substituted 
carbomonocycle, alkyl peroxide-initiated (PMN P-16-503) 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). It is a significant new use to 
manufacture the substance with an average molecular weight lower than 
1,500 dalton or more than 24% by weight of acid monomer in the polymer.
    (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 and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
11. Add Sec.  [emsp14]721.11123 to subpart E to read as follows:


Sec.  [emsp14]721.11123  Carboxilic acids, C6-18 and C8-15-di, polymers 
with diethylene glycol, glycerol, oleic acid, phthalic, acid and 
sorbitol.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as Carboxilic acids, 
C6-18 and C8-15-di, polymers with diethylene glycol, glycerol, oleic 
acid, phthalic, acid and sorbitol (CAS: 1877295-51-6) (PMN P-16-570) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the PMN substance after they have 
been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (b)(concentrations set at 0.1%) and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a), (b), (c), (d), (e)(concentration set at 1.0%), (f), 
(g)(1)(vi), (ix), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (g)(4)(iii) 
and (g)(5). Alternative hazard and warning

[[Page 43538]]

statements that meet the criteria of the Globally Harmonized System 
(GHS) and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q). It is a significant new use to use the 
substance other than as an aromatic polyester polyol for manufacturing 
rigid foam. It is a significant new use to manufacture the substance 
with residual phthalate greater than 0.1% by weight. It is a 
significant new use to modify the manufacturing, processing or use 
activities of the PMN substance to result in the generation of a vapor, 
mist or aerosol.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (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 (i) and (k) 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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

[FR Doc. 2018-18534 Filed 8-24-18; 8:45 am]
 BILLING CODE 6560-50-P