[Federal Register Volume 83, Number 192 (Wednesday, October 3, 2018)]
[Rules and Regulations]
[Pages 49806-49826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21194]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2018-0627; FRL-9983-82]
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 26 chemical substances 
which were the subject of premanufacture notices (PMNs). The chemical 
substances are subject to Orders issued by EPA pursuant to sections 
5(e) and 5(f) of TSCA. This action requires persons who intend to 
manufacture (defined by statute to include import) or process any of 
these 26 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 December 3, 2018. For purposes of

[[Page 49807]]

judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
October 17, 2018.
    Written adverse comments on one or more of these SNURs must be 
received on or before November 2, 2018 (see Unit VI. of the 
SUPPLEMENTARY INFORMATION). If EPA receives written adverse comments, 
on one or more of these SNURs before November 2, 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-2018-0627, 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: [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 November 2, 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 http://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 
November 2, 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.

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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 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 26 
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 26 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) or 5(f) 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 section of these rules specifies 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 26 PMN substances that are subject to Orders 
under TSCA section 5(e)(1)(A) or section 5(f)(3)(A). Each Order is 
based on one or more of the findings in TSCA section 5(a)(3)(A) or 
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 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; presents an unreasonable risk of 
injury to health or environment. 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 determined that the PMN substance presents or may present 
an unreasonable risk of injury to human health via inhalation exposure, 
the underlying TSCA section 5(e) or 5(f) Order required, 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

[[Page 49809]]

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-10-366

    Chemical name: Carbon nanomaterial (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: May 11, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be in printing 
applications. EPA identified concerns for pulmonary toxicity and 
carcinogenicity based on analogy to carbon black. The Order was issued 
under TSCA sections 5(e)(1)(A)(i), based on a finding that the 
available information is insufficient to permit a reasoned evaluation 
of the human health and environmental effects of the PMN substance. The 
Order was also issued under TSCA section 5(e)(l)(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 human health and the environment. To protect against these 
risks, the Order requires:
    1. Submission to EPA of certain health testing and material 
characterization data before exceeding a specified confidential 
production volume;
    2. Use of personal protective equipment where there is a potential 
for dermal exposure;
    3. Use of a National Institute for Occupational Safety and Health 
(NIOSH) certified air purifying, tight-fitting full-face respirator 
equipped with N100, P-100, or R-100 filter with an Assigned Protection 
Factor (APF) of at least 50 where there is a potential for inhalation 
exposure;
    4. No release of the PMN substance to surface waters;
    5. Use of the PMN substance only for the confidential uses 
specified in the Order;
    6. Limit the manufacture, processing and use of the PMN substance 
to industrial uses;
    7. No processing or use of the powder form of the PMN substance 
outside of the site of manufacture/processing; and
    8. No processing or use of the PMN substance in the liquid resin 
form using an application method that generates a vapor, mist, or 
aerosol.
    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 health effects 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 certain time limits without performing 
specific physical-chemical property tests and characterization and 
pulmonary effects testing. EPA has also determined that the results of 
a carcinogenicity study would help characterize the potential health 
effects caused by the PMN substance. Although the Order does not 
require this test, 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 721.11149.

PMN Number: P-14-627

    Chemical name: Cyclic amide (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: November 16, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be in dispersions for industrial coatings (e.g., 
polyurethane, acrylic, epoxy), coating for consumer and professional 
use, adhesives and sealants, solvent-borne industrial coatings silicon 
wafer cleaning in microelectronics in clean rooms, photoresist 
stripping in microelectronics in clean rooms, coatings for 
microelectronics (e.g., casting of polymer films) in clean rooms, 
reaction medium for polymerization, polymer coatings for industrial and 
professional applications (e.g., wire enamel, non-stick and friction 
reduction coating) membranes, solvent for chemical synthesis reactions 
(e.g., pharmaceuticals), formulation of inks, industrial cleaner (e.g., 
cleaner for wind turbine, oil rigs, large engines), solvent for 
cleaning industrial reactors, wax inhibitors (in hydrocarbon lines), 
petrochemical extraction processes, paint stripper, solvents for 
production and formulation of fertilizer, solvent for production and 
formulation of active ingredients for agriculture, and solvent for 
formulation of active ingredients for agriculture-end use pesticide 
products. Based on test data on the PMN substance, EPA identified 
concerns for developmental and reproductive toxicity, skin irritation, 
and systemic toxicity. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(l)(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. The 
Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 
5(e)(1)(A)(ii)(II), based on a finding that the substance either enters 
or may reasonably be anticipated to enter the environment in 
substantial quantities, or there is or may be significant (or 
substantial) human exposure to the substance. To protect against these 
risks, the Order requires:
    1. Use of personal protective where there is a potential for dermal 
exposures;
    2. Refraining from domestic manufacture of the PMN substance in the 
United States (i.e., import only);
    3. Import the PMN substance only according to the terms specified 
in the Order;
    4. Use of the PMN substance only for the uses and concentrations 
specified in the Order;
    5. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the Safety Data Sheet (SDS);
    6. Processing and use of the PMN substance only for uses specified 
in the Order; and
    7. No use of the PMN substance in hand held spray applications that 
generate a vapor, mist, or aerosol.
    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 of the PMN substance may be potentially 
useful to characterize the health 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. 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 721.11150.

PMN Number: P-15-114

    Chemical name: 2-Butanone 1,1,1,3,4,4,4-heptafluoro-3-
(trifluoromethyl)-.
    CAS number: 756-12-7.
    Effective date of TSCA section 5(e) Order: December 13, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a dielectric medium

[[Page 49810]]

for medium and high voltage power generation/distribution equipment and 
heat transfer. Based on analysis of test data on the PMN substance, EPA 
identified concerns for irritation of eyes, skin, lungs, and mucous 
membranes. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) 
and 5(e)(l)(A)(ii)(I) of TSCA, 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. Use of personal protective equipment where there is a potential 
for dermal exposure;
    2. Establishment and use of a hazard communication program, label 
containers of the PMN substance with the statement: ``contains a 
dielectric fluid which should not be mixed or used in conjunction with 
sulfur hexafluoride (SF6)'' and provide SDS and worker training in 
accordance with the provisions of the Hazard Communication Program 
section;
    3. No manufacture of the PMN substance beyond a confidential annual 
production volume (which includes import) specified in the Order;
    4. No use other than as a dielectric medium for medium and high 
voltage power generation/distribution equipment and heat transfer as 
described in the Order; and
    5. No release of the PMN substance resulting in surface water 
concentrations that exceed 180 parts per billion (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 environmental and health effects 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 specific chronic aquatic 
toxicity and pulmonary effects testing would help characterize the 
potential environmental and health effects of the PMN substance. 
Although the Order does not require this information, the Order's 
restrictions 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 721.11151.

PMN Number: P-15-320

    Chemical names: Propanenitrile, 2,3,3,3 tetrafluoro- 2-
(trifluoromethyl)-.
    CAS number: 42532-60-5.
    Effective date of TSCA section 5(e) Order: October 18, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a dielectric medium for medium and high 
voltage power generation and distribution equipment. Based on analysis 
of test data on the PMN substance, EPA identified concerns for 
neurotoxicity and irritation of eyes, skin, lungs, and mucous 
membranes. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) 
and 5(e)(l)(A)(ii)(I) of TSCA, 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. To 
protect against these risks, the Order requires:
    1. Establishment and use of a hazard communication program, label 
containers of the PMN substance with the statement: ``contains a 
dielectric fluid which should not be mixed or used in conjunction with 
sulfur hexafluoride (SF6)'' and provide SDS and worker training in 
accordance with the provisions of the Hazard Communication Program 
section; and
    2. Manufacturing, processing, or use as a dielectric medium for 
medium and high voltage power generation and distribution equipment as 
described in the PMN.
    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 health effects 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 specific pulmonary effects testing would 
help characterize the potential health effects of the PMN substance. 
Although the Order does not require this test, the Order's restrictions 
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 721.11152.

PMN Number: P-15-734

    Chemical name: Polymeric sulfide (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: October 11, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be for wastewater heavy metals removal. Based on 
physical/chemical properties of the PMN substance, EPA identified 
concerns for severe skin irritation, corrosion, neurotoxicity, 
developmental toxicity, and reproductive toxicity. The Order was issued 
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 
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. The Order was also issued 
under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(l)(A)(ii)(II), based on 
a finding that the substance is or will be produced in substantial 
quantities and that the substance either enters or may reasonable be 
anticipated to enter the environment in substantial quantities, or 
there is or may be significant (or substantial) human exposure to the 
chemical substance. To protect against these risks, the Order requires:
    1. Submission of certain health testing on the PMN substance prior 
to exceeding the confidential production volume limit specified in the 
Order;
    2. Use of personal protective equipment where there is a potential 
for dermal exposure;
    3. No modification of the manufacturing, processing, or use 
activities of the PMN substance that result in inhalation exposure to 
workers;
    4. Use of the PMN substance only for wastewater heavy metal removal 
as specified in the Order;
    5. No release of the PMN substance resulting in surface water 
concentrations that exceed 2 ppb; and
    6. 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 environmental and health effects 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 a certain confidential 
production volume limit without performing reproductive/

[[Page 49811]]

developmental toxicity testing and acute aquatic toxicity testing.
    CFR citation: 40 CFR 721.11153.

PMN Numbers: P-16-356 and P-16-357

    Chemical name: Quaternary ammonium salts (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: February 27, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances will be as wellbore additives. 
EPA has identified concerns for irritation for the substances based on 
the pH and concerns for lung effects based on the surfactant 
properties. Based on analogy to cationic surfactants, EPA has 
identified ecotoxicity hazard concerns. 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. The Order was also issued under TSCA 
sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding 
that the substances will be produced in substantial quantities and that 
the substances may reasonably be anticipated to enter the environment 
in substantial quantities and there may be significant human exposure 
to the PMN substances. To protect against these risks, the Order 
requires:
    1. Use of personal protective equipment where there is potential 
for dermal exposure;
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    3. Refrain from manufacturing, processing or using the PMN 
substances in a manner that generates a vapor, mist, or aerosol; and
    4. No use of the PMN substances other than the confidential use 
described in the Order.
    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 health and environmental effects 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 specific pulmonary effects 
testing would help characterize the potential health effects of the PMN 
substances and results of acute aquatic toxicity testing would help 
characterize the potential environmental effects of the PMN substances. 
Although the Order does not require this test, the Order's restrictions 
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 721.11154.

PMN Number: P-16-375

    Chemical name: Alkyl methacrylates, polymer with olefins (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: October 17, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a binder for seal 
application. Based on physical/chemical properties of the PMN 
substance, EPA identified concerns for lung toxicity. The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of 
TSCA, 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. Refraining from domestic manufacture of the PMN substance in the 
United States (i.e., import only); and
    2. Import of the PMN substance according to the confidential 
molecular weight parameters specified in the Order.
    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 health and environmental effects 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 specific pulmonary effects 
testing and fate testing would help characterize the potential health 
effects of the PMN substance and results of acute aquatic toxicity 
testing would help characterize the potential environmental effects of 
the PMN substance. Although the Order does not require these tests, the 
Order's restrictions 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 721.11155.

PMN Number: P-16-386

    Chemical name: Hexanedioic acid, 1,6-bis(3,5,5-trimethylhexyl) 
ester.
    CAS number: 20270-50-2.
    Effective date of TSCA section 5(e) Order: October 12, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as a seal swell agent for motor formulations and 
gear oil lubricants. Based on analysis of an analogous compound, EPA 
has identified concerns for solvent neurotoxicity, liver and kidney 
effects, and concern for developmental toxicity based on analysis of 
testing for a potential degradant of the PMN substance. 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. To protect against these risks, the Order 
requires:
    1. Submit to EPA certain toxicity testing prior to manufacturing 
1,545,000 kilograms of the PMN substance;
    2. Use of personal protective equipment where there is a potential 
for dermal exposure;
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS; and
    4. Use of the PMN substance only for the use specified in the 
Order.
    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 health effects 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 1,545,000 kilogram production volume limit 
without performing specific target organ/reproductive/developmental 
toxicity testing.
    CFR citation: 40 CFR 721.11156.

PMN Number: P-16-396

    Chemical name: Alkylaminium hydroxide (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: December 19, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the PMN substance

[[Page 49812]]

will be as a specialty chemical for processing additive. Based on 
structural alerts and analysis of analogue data, EPA identified 
concerns for neurotoxicity, developmental and reproductive toxicity and 
irritation. EPA also identified concerns for lung effects based on 
surfactant properties and corrosivity and concern for reproductive and 
developmental toxicity based on analogue data from large quaternary 
ammonium compounds. 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. To 
protect against these risks, the Order requires:
    1. Submission of certain health testing on the PMN substance prior 
to exceeding the confidential production volume limit as specified in 
the Order;
    2. Use of personal protective equipment where there is a potential 
for dermal exposure;
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    4. No manufacturing, processing, or use of the PMN substance as a 
solid or powder;
    5. Use of the PMN substance only for the confidential uses 
specified in the Order; and
    6. No use of the PMN substance in application methods that generate 
a dust, vapor, mist, or aerosol.
    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 health effects 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 a certain production volume limit without 
performing reproductive/developmental toxicity testing.
    CFR citation: 40 CFR 721.11157.

PMN Numbers: P-16-572 and P-16-573

    Chemical name: Polyamine polyacid adducts (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: September 27, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances will be as adhesives for 
coatings. Based on physical chemical properties of the PMN substances, 
EPA identified potential concerns for lung toxicity and aquatic/
terrestrial toxicity if the PMN substances are manufactured in such a 
manner that they are amine terminated. The Order was issued under TSCA 
sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a finding that the 
available information is insufficient to permit a reasoned evaluation 
of the health and environmental effects for the PMN substances. The 
Order was also issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(l)(A)(ii)(I) of TSCA, 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 human health and the 
environment. To protect against these risks, the Order requires:
    1. Manufacture of the PMN substances in a manner that they are not 
amine terminated in order to maintain water solubility levels below 1 
ppb.
    The SNUR designates as a ``significant new use'' the absence of 
this protective measure.
    Potentially useful information: EPA has determined that certain 
information about the physical-chemical properties and health effects 
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 
specific physical-chemical property tests and target organ toxicity 
testing would help characterize the potential health effects of the PMN 
substances. Although the Order does not require these tests, the 
Order's restrictions 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 721.11158.

PMN Numbers: P-17-24 and P-17-25

    Chemical names: Aromatic isocyanate, polymer with alkyloxirane 
polymer with oxirane ether with alkyldiol (2:l), and alkyloxirane 
polymer with oxirane ether with alkyltriol (3:l) (generic) (P-17-24) 
and aromatic isocyanate polymer with alkyloxirane, alkyloxirane polymer 
with oxirane ether with alkanetriol and oxirane (generic) (P-17-25).
    CAS numbers: Not available.
    Effective date of TSCA section 5(f) Order: October 31, 2017.
    Basis for TSCA section 5(f) Order: The PMN states that the generic 
(non-confidential) use of the substances will be as urethane 
components. EPA identified concerns for oncogenicity based on physical 
chemical properties of the PMN substances, mutagenicity based on data 
for analogous chemicals, and respiratory and dermal sensitization and 
lung and mucous membrane irritation based on the isocyanate moiety. The 
Order was issued under sections 5(a)(3)(A) and 5(f)(1) of TSCA, based 
on a finding that the substances present an unreasonable risk of injury 
to human health. To protect against these risks, the Order requires:
    1. Use of personal protective equipment where there is a potential 
for dermal exposure;
    2. No manufacturing, processing, or use of the PMN substances in 
application methods that generate a vapor, dust, mist, or aerosol;
    3. No use of the PMN substances in a consumer product; and
    4. 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.
    CFR citation: 40 CFR 721.11159 and 40 CFR 721.11160.

PMN Number: P-17-148

    Chemical name: Oils, Hedychium Flavescens.
    CAS number: 1902936-65-5.
    Effective date of TSCA section 5(e) Order: December 15, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as an odoriferous component of fragrance 
compounds. Based on test data on PMN constituents, EPA has identified 
concerns for oncogenicity, developmental toxicity, liver, kidney, and 
male reproductive effects. EPA also identified concern for 
sensitization based on submitted test data on the PMN mixture. The 
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(II), based on a finding that in the absence of 
sufficient information to permit a reasoned evaluation, the substance 
may present an unreasonable risk on injury to health. To protect 
against these risks, the Order requires:
    1. Use of personal protective equipment where there is a potential 
for dermal exposures;
    2. Use of a NIOSH-certified respirator with an APF of at least 50 
where there is a potential for inhalation exposures;
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;

[[Page 49813]]

    4. Refraining from domestic manufacture of the PMN substance in the 
United States (i.e., import only);
    5. Not manufacture the PMN substance beyond an annual production 
volume of 70 kilograms;
    6. Not manufacture, process, or use the PMN substance in any manner 
or method that generates mist or aerosol; and
    7. Not use the PMN substance other than as an odoriferous component 
of fragrance compounds.
    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 health effects 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 specific skin absorption, and chronic 
toxicity/carcinogenicity testing would help characterize the potential 
health effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions 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 721.11161.

PMN Number: P-17-174

    Chemical name: Alkyltriethosysilylpolysiloxane (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: November 28, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a plastic additive. 
Based on analysis of test data on analogous alkoxysilanes, EPA 
identified concerns for lung effects, irritation, developmental 
toxicity, and neurotoxicity. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 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. To protect against these risks, the Order requires:
    1. Submission to EPA of certain health testing before manufacturing 
(including import) the aggregate confidential volume identified in the 
Order;
    2. Use of personal protective equipment where there is a potential 
for dermal exposure;
    3. No manufacturing or use of the PMN substance in application 
methods that generate a vapor, mist, or aerosol;
    4. Refraining from domestic manufacture of the PMN substance in the 
United States (i.e., import only);
    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 health effects 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 a confidential production volume limit without 
performing specific target organ toxicity testing.
    CFR citation: 40 CFR 721.11162.

PMN Numbers: P-17-200 and P-17-204

    Chemical names: 1,3-bis(substitutedbenzoyl)benzene (generic) (P-17-
200) and 1,4-bis(substitutedbenzoyl)benzene (generic) (P-17-204).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: December 18, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the use of 
the substances will be as monomers for high performance polymers. Based 
on analysis of test data on analogous chemical bisphenol A and 
predictions for polyphenols, EPA identified potential concerns for 
irritation to the eyes, lungs, and mucous membranes, liver and kidney 
effects, reproductive and developmental toxicity, sensitization, 
neurotoxicity, and aquatic/terrestrial toxicity. The Order was issued 
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 
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 the health and the environment. To 
protect against these risks, the Order requires:
    1. Use of personal protective equipment where there is a potential 
for dermal exposure;
    2. Use of a NIOSH certified respirator with an APF of at least 50 
where there is a potential for inhalation exposure;
    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 substances only in the 
form of a solid;
    5. Refraining from domestic manufacture of the PMN substances in 
the United States (i.e., import only);
    6. No manufacture (including import), processing, or use of the PMN 
substances with greater than 0.1% of the particle size distribution 
less than 10 microns;
    7. No use other than as chemical intermediates;
    8. No release of the PMN substances into the waters of the United 
States without application of an on-site wastewater treatment that 
reduces the concentration of PMN substances in wastewater below the 
limit of detection of 0.03 ppm, using the on-site wastewater treatment 
system with activated carbon adsorption; and
    9. Disposal of the PMN substances by incineration.
    The SNURs designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the environmental and health effects 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 these 
SNURs. EPA has also determined that the results of specific 
reproductive toxicity testing, skin sensitization, and chronic aquatic 
toxicity testing would help characterize the potential human and 
environmental effects of the PMN substances. Although the Order does 
not require these tests, the Order's restrictions 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 721.11163 and 40 CFR 721.11164.

PMN Number: P-17-205

    Chemical name: Bis(fluorobenzoyl)benzene (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: December 18, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will

[[Page 49814]]

be as a monomer for high performance polymers. Based on physical/
chemical properties of the PMN substance (as described in the New 
Chemical Program's PBT category at 64 FR 60194; November 4, 1999) and 
test data on structurally similar substances, the PMN substance is a 
potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA 
has identified concern for eye irritation based on test data for an 
analogous chemical. Concerns for liver, kidney, blood effects and 
carcinogenicity were identified based on test data available for 
benzophenone. Based on experimental data of an analogous chemical, EPA 
has identified environmental hazard concerns. 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 PMN substance may present an unreasonable risk 
of injury to health and the environment. To protect against these 
risks, the Order requires:
    1. Use of personal protective equipment where there is a potential 
for dermal exposure;
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    3. Refraining from domestic manufacture of the PMN substance in the 
United States (i.e., import only);
    4. Manufacture of the PMN substance only in the form of a solid;
    5. No manufacture of the PMN substance with greater than 0.1% of 
the particle size distribution less than 10 microns;
    6. No use other than as a chemical intermediate;
    7. Disposal of the PMN substance by incineration; and
    8. No release of the PMN without application of an on-site 
wastewater treatment that reduces the concentration of the PMN in 
wastewater below the limit of detection of 0.03 ppm.
    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 health effects 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 also determined that the results of biodegradability testing, 
bioaccumulation testing, specific reproductive and developmental 
toxicity testing, and chronic aquatic toxicity testing would help 
characterize the potential human and environmental effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions 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 721.11165.

PMN Number: P-17-251

    Chemical name: 1-H-Benz[DE] isoquinoline-1,3 (2H)-dione-2-(-alkyl-
)- (-alkyl-amino-) (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: December 13, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the specific 
(non-confidential) use of the substance will be as tracer dye. Based on 
the physical/chemical properties of the PMN substance and data for 
structurally analogous chemical substances, EPA has identified concerns 
for mutagenicity and ocular irritation. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(II), based on finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the PMN substance may present an unreasonable risk of 
injury to health. To protect against these risks, the Order requires:
    1. Use of personal protective equipment where there is a potential 
for exposure;
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    3. Refraining from domestic manufacture of the PMN substance in the 
United States (i.e., import only); and
    4. No import, processing, or use of the PMN substance at a 
concentration greater than 0.4%.
    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 health effects 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 specific skin absorption testing and 
genetic toxicology testing would help characterize the potential health 
effects of the PMN substance. Although the Order does not require this 
test, the Order's restrictions 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 721.11166.

PMN Number: P-17-296

    Chemical name: Siloxanes and Silicones, di-Me, hydrogen-terminated, 
reaction products with acrylic acid and 2-ethyl-2-[(2-propen-1-
yloxyl)methyl]-1,3-propanediol, polymers with chlorotrimethylsilane-
iso-Pr alc.-sodium reaction products.
    CAS number: 2014386-23-1.
    Effective date of TSCA section 5(e) Order: November 14, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a component of release coating mixture for 
paper and film. Based on analogy to acrylates, EPA identified concerns 
for dermal and respiratory sensitization, mutagenicity, oncogenicity, 
developmental toxicity, and irritation to all tissues. The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of 
TSCA, 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. To protect against these risks, 
the Order requires:
    1. Use of personal protective equipment where there is a potential 
for dermal exposure;
    2. Use of a NIOSH certified respirator with an APF of at least 
1,000 if used in a manner that generates a spray, mist, or aerosol and 
there is a potential for inhalation exposure;
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS; and
    4. Refraining from domestic manufacture of the PMN substance in the 
United States (i.e., import only).
    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 health effects 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 specific reproductive/developmental 
toxicity testing, skin sensitization and genetic toxicology testing 
would help characterize the potential health effects of the PMN 
substance. Although the

[[Page 49815]]

Order does not require these tests, the Order's restrictions 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 721.11167.

PMN Numbers: P-17-308 and P-17-309

    Chemical names: 2-Pentanone, 2,2',2''-[O,O',O''-
(ethenylsilylidyne)trioxime] (P-17-308) and 2-Pentanone, 2,2',2''- 
[O,O',O''-(methylsilylidyne)trioxime] (P-17-309).
    CAS numbers: 58190-62-8 (P-17-308) and 37859-55-5 (P-17-309).
    Effective date of TSCA section 5(e) Order: October 30, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the use of 
the substances will be as crosslinkers for silicone sealants used in 
automotive and large appliance (white goods) manufacture and for 
silicone sealants used in auto repair shops. Based on hazard 
determination and available qualitative risk information, EPA has 
identified concerns for irritation, corrosion, sensitization; systemic 
effects to spleen, liver and bone marrow; developmental, reproductive, 
blood, and kidney toxicity; neurotoxicity, mutagenicity and 
oncogenicity. 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. To 
protect against these risks, the Order requires:
    1. Submission to EPA of certain toxicity testing on P-17-308 before 
manufacturing the aggregate confidential production volume identified 
in the Order;
    2. Provide personal protective equipment where there is a potential 
for dermal exposure;
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    4. Refraining from domestic manufacture of the PMN substances in 
the United States (i.e., import only); and
    5. Not process or use the PMN substances in any application that 
creates vapor, mist or aerosol.
    The SNURs designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects 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 these SNURs. The 
submitter has agreed not to exceed a confidential production volume 
limit without performing reproductive/developmental toxicity testing 
and skin sensitization testing on P-17-308.
    CFR citation: 40 CFR 721.11168 and 40 CFR 721.11169.

PMN Number: P-17-321

    Chemical name: Naphthalene trisulfonic acid sodium salt (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: October 25, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be for monitoring of oil/
gas well performance. Based on physical/chemical properties of the PMN 
substance and analysis of test data on analogous chemicals, EPA 
identified concerns for developmental toxicity and interference with 
blood clotting via chelation of nutrient metals, dermal and lung 
irritation, and sensitization. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 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. To protect against these risks, the Order requires:
    1. Submission to EPA of certain toxicity testing before 
manufacturing (including import) the confidential aggregate volume 
identified in the Order;
    2. Use of personal protective equipment where there is a potential 
for dermal exposure and a NIOSH certified respirator with an APF of at 
least 50 where there is a potential for inhalation exposure;
    3. No manufacturing, processing, or use of the PMN substance in any 
manner that generates a vapor, mist, or aerosol;
    4. No manufacture (including import) or processing of the PMN 
substance beyond the confidential annual production volume specified in 
the Order; 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 health effects 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 a confidential production volume limit without 
performing reproductive/developmental toxicity testing and skin 
sensitization testing.
    CFR citation: 40 CFR 721.11170.

PMN Number: P-17-327

    Chemical name: Polymer of aliphatic dicarboxylic acid and dicyclo 
alkane amine (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: October 18, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the PMN substance will be for injection molding of special applications 
and in compounding. Based on physical/chemical properties of the PMN 
substance, there are no significant concerns for the PMN substance as 
described in the PMN submission. However, if the PMN substance is made 
differently, there could be concern for lung toxicity. The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of 
TSCA, 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. To protect against these risks, 
the Order requires:
    1. Manufacture (which under TSCA includes importing) the PMN 
substance to have an average molecular weight of no greater than 10,000 
Daltons.
    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 health effects 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 also 
determined that the results of specific acute toxicity and pulmonary 
effects testing would help characterize the potential health effects of 
the PMN substance. Although the Order does not require these tests, the 
Order's restrictions remain in effect until the Order is modified or 
revoked by EPA based on submission and review of this or other relevant 
information.
    CFR citation: 40 CFR 721.11171.

[[Page 49816]]

PMN Number: P-17-330

    Chemical name: Hexanedioic acid, polymer with trifunctional polyol, 
1,1'-methylenebis [isocyanatobenzene], and 2,2'-oxybis [ethanol] 
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: November 13, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a polyurethane which is cured and used in a 
sprocket for water treatment. Based on physical/chemical properties of 
the PMN substance, EPA identified concerns for irritation to the eye, 
skin, respiratory tract, and gastrointestinal tract and for potential 
dermal and respiratory sensitization. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 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. To protect against these risks, the Order requires:
    1. Use of personal protective equipment where there is a potential 
for dermal exposure;
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    3. No manufacture, processing, or use of the PMN substance in any 
manner that generates a dust, mist, or aerosol; and
    4. No use of the PMN substance in a consumer product or for 
commercial uses when the sealable goods or service could introduce the 
PMN material into a consumer setting.
    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 health effects 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 also 
determined that the results of specific skin sensitization testing 
would help characterize the potential health effects of the PMN 
substance. Although the Order does not require this test, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission and review of this or other relevant 
information.
    CFR citations: 40 CFR 721.11172.

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 26 chemical 
substances, regulation was warranted under TSCA section 5(e) or section 
5(f), 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) or 5(f) 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 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 
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. Direct Final Procedures

    EPA is issuing these SNURs as a direct final rule. The effective 
date of this rule is December 3, 2018 without further notice, unless 
EPA receives written adverse comments before November 2, 2018.
    If EPA receives written adverse comments on one or more of these 
SNURs before November 2, 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) or 5(f) Orders have 
been issued for all of the chemical substances, and the PMN submitters 
are prohibited by the TSCA section 5(e) and 5(f) Orders from 
undertaking activities which will be designated as significant new 
uses. The identities of 20 of the 26 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 October 3, 2018 as the cutoff date for 
determining whether the new use is ongoing. The objective of EPA's 
approach has been to

[[Page 49817]]

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 tests 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).
    In certain of the TSCA section 5(e) Orders for the chemical 
substances regulated under this rule, EPA has established production or 
time 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. The SNURs contain the same limits 
as the TSCA section 5(e) Orders. Exceeding these limits is defined as a 
significant new use. Persons who intend to exceed the 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.
    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 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.

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 http://www.epa.gov/opptintr/newchems.

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors

[[Page 49818]]

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-2018-0627.

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) or 5(f) 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.
     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).

[[Page 49819]]

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: September 14, 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
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
721.11149...............................................       2070-0012
721.11150...............................................       2070-0012
721.11151...............................................       2070-0012
721.11152...............................................       2070-0012
721.11153...............................................       2070-0012
721.11154...............................................       2070-0012
721.11155...............................................       2070-0012
721.11156...............................................       2070-0012
721.11157...............................................       2070-0012
721.11158...............................................       2070-0012
721.11159...............................................       2070-0012
721.11160...............................................       2070-0012
721.11161...............................................       2070-0012
721.11162...............................................       2070-0012
721.11163...............................................       2070-0012
721.11164...............................................       2070-0012
721.11165...............................................       2070-0012
721.11166...............................................       2070-0012
721.11167...............................................       2070-0012
721.11168...............................................       2070-0012
721.11169...............................................       2070-0012
721.11170...............................................       2070-0012
721.11171...............................................       2070-0012
721.11172...............................................       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.  721.11149 to subpart E to read as follows:


Sec.  721.11149   Carbon nanomaterial (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as carbon 
nanomaterial (P-10-366) 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 
substance after they have been reacted (cured), incorporated or 
embedded into a polymer matrix that itself has been completely reacted 
(cured), embedded in a permanent solid polymer, metal, glass, or 
ceramic form, or completely embedded in an article as defined at 40 CFR 
720.3(c).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i)(ii), (a)(3), (a)(4), (a)(5) (respirators must 
provide a National Institute for Occupational Safety and Health 
certified air purifying, tight-fitting full-face respirator equipped 
with N100, P-100, or R-100 filter with an Assigned Protection Factor of 
at least 50), (a)(6)(particulate), (when determining which persons are 
reasonable 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 exposures, where feasible), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k), (l), (q), and (y)(1)(when the 
substance is in liquid resin form). It is a significant new use to 
process or use the powder form of the substance outside of the site of 
manufacture or processing.
    (iii) 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 (e), (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)(ii) of 
this section.

0
5. Add Sec.  721.11150 to subpart E to read as follows:


Sec.  721.11150   Cyclic amide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as cyclic 
amide (P-14-627) 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)(butyl or silver shield gloves), (a)(2)(iv), 
(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 shall be considered and implemented to prevent 
exposure, where feasible), (b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ix), 
(g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized

[[Page 49820]]

System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (k)(dispersions for industrial 
coatings (e.g., polyurethane, acrylic, epoxy), coating for consumer and 
professional use, adhesives and sealants, solvent-borne industrial 
coatings silicon wafer cleaning in microelectronics in clean rooms, 
photoresist stripping in microelectronics in clean rooms, coatings for 
microelectronics (e.g., casting of polymer films) in clean rooms, 
reaction medium for polymerization, polymer coatings for industrial and 
professional applications (e.g., wire enamel, non-stick and friction 
reduction coating) membranes, solvent for chemical synthesis reactions 
(e.g., pharmaceuticals), formulation of inks, industrial cleaner (e.g., 
cleaner for wind turbine, oil rigs, large engines), solvent for 
cleaning industrial reactors, wax inhibitors (in hydrocarbon lines), 
petrochemical extraction processes, paint stripper, solvents for 
production and formulation of fertilizer, solvent for production and 
formulation of active ingredients for agriculture, and solvent for 
formulation of active ingredients for agriculture-end use pesticide 
product). It is a significant new use to import the substance other 
than in containers of 55 gallons or more when the concentration is 
greater than 5% by weight for any product either intended for sale or 
distribution for ``consumer'' use, including for use in ``consumer 
products'', or both intended for ``commercial use'' and rnade available 
to consumers for retail purchase of any kind. It is a significant new 
use to use in hand held spray applications that generate a vapor, mist, 
or aerosol.
    (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).
    (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
6. Add Sec.  721.11151 to subpart E to read as follows:


Sec.  721.11151   2-Butanone 1,1,1,3,4,4,4-heptafluoro-3-
(trifluoromethyl)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-Butanone 
1,1,1,3,4,4,4-heptafluoro-3-(trifluoromethyl)- (P-15-114, CAS No 756-
12-7) 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), and (a)(3)(when determining which persons are 
reasonable 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 exposures, where feasible), 
(b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(i), (g)(2)(i)(v), (g)(3)(ii)(harmful 
to fish), (g)(4)(iii), and (g)(5). It is a significant new use unless 
containers of the PMN substance are labeled with the statement: 
``contains a dielectric fluid which should not be mixed or used in 
conjunction with sulfur hexafluoride (SF6)''. Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(t). It is a significant new use to use the 
substance other than as a dielectric medium for medium and high voltage 
power generation/distribution equipment and heat transfer.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 180.
    (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, 
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)(iii) 
of this section.

0
7. Add Sec.  721.11152 to subpart E to read as follows:


Sec.  721.11152   Propanenitrile, 2,3,3,3 tetrafluoro- 2-
(trifluoromethyl)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as propanenitrile, 
2,3,3,3 tetrafluoro- 2-(trifluoromethyl)- (P-15-320, CAS No 42532-60-5) 
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) through (e)(concentration set at 1%), (f), and (g)(5). It is 
a significant new use unless containers of the PMN substance are 
labeled with the statement: ``contains a dielectric fluid which should 
not be mixed or used in conjunction with sulfur hexafluoride (SF6)''). 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. It is a significant new use to use the 
substance other than as a dielectric medium for medium and high voltage 
power generation and distribution equipment.
    (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 (f) through (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.

0
8. Add Sec.  721.11153 to subpart E to read as follows:


Sec.  721.11153   Polymeric sulfide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
polymeric sulfide (P-15-734) 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), (when determining which persons are 
reasonable 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

[[Page 49821]]

control measures (e.g., workplace policies and procedures) shall be 
considered and implemented to prevent exposures, where feasible), 
(b)(concentration set at 1%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1%), (f), (g)(1)(i), (vi), 
(ix), (neurotoxicity), (g)(2)(i), (iii), (v), (g)(3)(i), (ii), and 
(g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k)(wastewater heavy metal removal) and 
(q). It is a significant new use to manufacture, process, or use the 
substance in any manner that results in inhalation exposure to workers.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 2.
    (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, 
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)(iii) 
of this section.

0
9. Add Sec.  721.11154 to subpart E to read as follows:


Sec.  721.11154   Quaternary ammonium salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
quaternary ammonium salts (PMN P-16-356 and P-16-357) are 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 substances after they have been reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified Sec.  
721.63(a)(1), (a)(2)(i), (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)(concentration 
set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ii), 
(neurotoxicity), (g)(2)(i), (iii), (v), (g)(3)(i), (ii), and (g)(5). 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture, process, or use the substances in any manner way that 
results in generation of a vapor, mist or aerosol.
    (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).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
10. Add Sec.  721.11155 to subpart E to read as follows:


Sec.  721.11155   Alkyl methacrylates, polymer with olefins (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as alkyl 
methacrylates, polymer with olefins (P-16-375) 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 import 
the substance other than according to the confidential molecular weight 
parameters specified in the Order for the substance.
    (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.

0
11. Add Sec.  721.11156 to subpart E to read as follows:


Sec.  721.11156   Hexanedioic acid, 1,6-bis(3,5,5-trimethylhexyl) 
ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) the chemical substance identified as hexanedioic acid, 
1,6-bis(3,5,5-trimethylhexyl) ester (PMN P-16-386, CAS No 20270-50-2) 
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)(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 shall be considered and implemented to 
prevent exposure, where feasible), (a)(6)(v), (vi), (particulate), 
(b)(concentration set at 1%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1%), (f), (g)(1)(iii), (iv), 
(ix), (g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k)(motor oil formulations and gear oil 
lubricants) and (p)(1,545,000 kilograms).
    (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).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
11. Add Sec.  721.11157 to subpart E to read as follows:


Sec.  721.11157  Alkylaminium hydroxide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylaminium hydroxide (P-16-396) is subject to reporting under this 
section for the significant new uses

[[Page 49822]]

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), (ii), (iii), (iv), (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 exposures, 
where feasible), (b)(concentration set at 1%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.71(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(ii), (iii), (vi), (ix), (eye damage), (g)(2)(i), (ii), (iii), (v), and 
(g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k), (q), (v)(1), (2), (w)(1), (2), (x)(1), 
(x)(2), (y)(1), and (y)(2).
    (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) 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)(iii) 
of this section.

0
12. Add Sec.  721.11158 to subpart E to read as follows:


Sec.  721.11158   Polyamine polyacid adducts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances generically identified as 
polyamine polyacid adducts (P-16-572 and P-16-573) 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. It is a significant new to use to 
manufacture the substances in any manner other than they are not amine 
terminated in order to maintain water solubility levels below 1 part 
per billion.
    (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 these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
13. Add Sec.  721.11159 to subpart E to read as follows:


Sec.  721.11159  Aromatic isocyanate, polymer with alkyloxirane polymer 
with oxirane ether with alkyldiol (2:l) and alkyloxirane polymer with 
oxirane ether with alkyltriol (3:l) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
aromatic isocyanate, polymer with alkyloxirane polymer with oxirane 
ether with alkyldiol (2:l) and alkyloxirane polymer with oxirane ether 
with alkyltriol (3:l) (P-17-24) 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 substance after they have been 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), (iv), (a)(3), (a)(6)(v), (vi), (particulate), 
(when determining which persons are reasonable 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 
exposures, where feasible), (b)(concentration set at 0.1%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 0.1%), (f), (g)(1)(i), (ii), 
(asthma), (g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative hazard 
and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in generation of a vapor, mist or aerosol.
    (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) 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.

0
14. Add Sec.  721.11160 to subpart E to read as follows:


Sec.  721.11160   Aromatic isocyanate polymer with alkyloxirane, 
alkyloxirane polymer with oxirane ether with alkanetriol and oxirane 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
aromatic isocyanate polymer with alkyloxirane, alkyloxirane polymer 
with oxirane ether with alkanetriol and oxirane (P-17-25) 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), (iv), (a)(3), (a)(6)(v), (vi), (particulate), 
(when determining which persons are reasonable 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 
exposures, where feasible), (b)(concentration set at 0.1%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 0.1%), (f), (g)(1)(i), (ii), 
(asthma), (g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative hazard 
and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in generation of a vapor, mist or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).

[[Page 49823]]

    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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.

0
15. Add Sec.  721.11161 to subpart E to read as follows:


Sec.  721.11161   Oils, Hedychium Flavescens.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as oils, hedychium 
flavescens, (PMN P-17-148, CAS No 1902936-65-5) 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), (iii), (iv), (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 50), (a)(6)(v), (vi), (b)(concentration set at 1%), and 
(c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(iv), (vi), (vii), (ix), (respiratory 
sensitization), (g)(2)(i), (ii), (iii), (iv), (v), and (g)(5). 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k)(odoriferous component of fragrance 
compounds) and (s)(70 kilograms). It is a significant new use to 
manufacture, process, or use the substance in any manner that generates 
a mist or aerosol.
    (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) 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
16. Add Sec.  721.11162 to subpart E to read as follows:


Sec.  721.11162   Alkyltriethosysilylpolysiloxane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkyltriethosysilylpolysiloxane (P-17-174) 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 substance after they have been 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), (a)(3), (when determining which persons are 
reasonable 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 exposures, where feasible), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ix), 
(neurotoxicity), (g)(2)(i), (v), and (g)(5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (q). It is a significant new use to 
manufacture or use the substance in any manner that results in 
generation of a vapor, mist or aerosol.
    (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) 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)(iii) 
of this section.

0
17. Add Sec.  721.11163 to subpart E to read as follows:


Sec.  721.11163   1,3-Bis(substitutedbenzoyl)benzene.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 1,3-
bis(substitutedbenzoyl)benzene (P-17-200) 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) or 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), (iii), (iv), (a)(3), (a)(4), 
(a)(5)(respirators must provide a National Safety Institute for 
Occupational Safety and Health assigned protection factor of at least 
50), (when determining which persons are reasonable 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 
exposures, where feasible), (b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), 
(iii), (iv), (vi), (ix), (sensitization), (irritation to the eyes, 
lungs, and mucous membranes), (g)(2)(i), (ii), (iii), (iv), (v), 
(g)(3)(i), (ii), (g)(4)(i), (water release restriction apply), and 
(g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (g), (w)(3), and (w)(4). It is a 
significant new use to manufacture, process, or use of the PMN 
substance with greater than 0.1% of the particle size distribution less 
than 10 microns.
    (iv) Disposal requirements. Requirements as specified in Sec.  
721.85(a)(1), (b)(1), and (c)(1).
    (v) Release to water. Requirements as specified in Sec.  
721.90(a)(2)(iv), (b)(2)(iv), and (c)(2)(iv). The concentration in 
released wastewater must be less than 0.03 ppm.
    (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 49824]]

Sec.  721.125(a) through (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.

0
18. Add Sec.  721.11164 to subpart E to read as follows:


Sec.  721.11164   1,4-Bis(substitutedbenzoyl)benzene (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,4-
bis(substitutedbenzoyl)benzene (P-17-204) 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) or 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), (iii), (iv), (a)(3), (a)(4), 
(a)(5)(respirators must provide a National Safety Institute for 
Occupational Safety and Health assigned protection factor of at least 
50), (when determining which persons are reasonable 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 
exposures, where feasible), (b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), 
(iii), (iv), (vi), (ix), (sensitization), (irritation to the eyes, 
lungs, and mucous membranes), (g)(2)(i), (ii), (iii), (iv), (v), 
(g)(3)(i), (ii), (g)(4)(i), (water release restriction apply), and 
(g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (g), (w)(3) and (4). It is a 
significant new use to manufacture, process, or use of the PMN 
substance with greater than 0.1% of the particle size distribution less 
than 10 microns.
    (iv) Disposal requirements. Requirements as specified in Sec.  
721.85(a)(1), (b)(1), and (c)(1).
    (v) Release to water. Requirements as specified in Sec.  
721.90(a)(2)(iv), (b)(2)(iv), and (c)(2)(iv). The concentration in 
released wastewater must be less than 0.03 ppm.
    (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, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
19. Add Sec.  721.11165 to subpart E to read as follows:


Sec.  721.11165   bis(fluorobenzoyl)benzene (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
bis(fluorobenzoyl)benzene (P-17-205) 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) or 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)(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 shall be considered and 
implemented to prevent exposure, where feasible), (b)(concentration set 
at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1%), (f), (g)(1)(iv), (vii), 
(eye irritation), (g)(2)(i), (ii), (iii), (g)(3)(i), (ii), (g)(4)(i), 
(water release restriction apply), and (g)(5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (g), (w)(3), and (w)(4). It is a 
significant new use to manufacture, process, or use of the PMN 
substance with greater than 0.1% of the particle size distribution less 
than 10 microns.
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(b)(1), and (c)(1).
    (v) Release to water. Requirements as specified in Sec.  
721.90(a)(2)(iv), (b)(2)(iv), and (c)(2)(iv). The concentration in 
released wastewater must be less than 0.03 ppm.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Record keeping 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.

0
20. Add Sec.  721.11166 to subpart E to read as follows:


Sec.  721.11166   1-H-Benz[DE] isoquinoline-1,3 (2H)-dione-2-(-alkyl-)-
(-alkyl-amino-) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 1-H-
Benz[DE] isoquinoline-1,3 (2H)-dione-2-(-alkyl-)-(-alkyl-amino-) (P-17-
251) 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), (iii), (iv), (a)(3), (when determining which 
persons are reasonably likely to be exposed as required as Sec.  
721.63(a)(1) engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation shall be 
considered and implemented to prevent exposure, where feasible), 
(a)(6)(v), (vi), (particulate), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(acute toxicity, mutagenicity, eye 
irritation), (g)(2)(i), (ii), (v), and (g)(5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to import, 
process, or use the PMN substance at a concentration greater than 0.4%.
    (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) are applicable to

[[Page 49825]]

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
21. Add Sec.  721.11167 to subpart E to read as follows:


Sec.  721.11167  Siloxanes and Silicones, di-Me, hydrogen-terminated, 
reaction products with acrylic acid and 2-ethyl-2-[(2-propen-1-
yloxyl)methyl]-1,3-propanediol, polymers with chlorotrimethylsilane-
iso-Pr alc.-sodium reaction products.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as siloxanes and 
silicones, di-Me, hydrogen-terminated, reaction products with acrylic 
acid and 2-ethyl-2-[(2-propen-1-yloxyl)methyl]-1,3-propanediol, 
polymers with chlorotrimethylsilane-iso-Pr alc.-sodium reaction 
products (P-17-296, CAS No. 2014386-23-1) 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), (a)(4), (a)(5), 
(respirators must provide a National Institute for Occupational Safety 
and Health assigned protection factor of at least 1,000 and are 
required for any process generating a spray, mist, or aerosol), (when 
determining which persons are reasonable 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 
exposures, where feasible), (a)(6)(v), (vi), (particulate), 
(b)(concentration set at 1%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1%), (f), (g)(1)(i), 
(sensitization) (iv), (vii), (ix), (g)(2)(i), (ii), (iii), (iv), (v), 
and (g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f).
    (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) 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.

0
22. Add Sec.  721.11168 to subpart E to read as follows:


Sec.  721.11168   2-Pentanone, 2,2',2''-[O,O',O''-
(ethenylsilylidyne)trioxime].

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance 2-pentanone, 2,2',2''-[O,O',O''-
(ethenylsilylidyne)trioxime] (PMN P-17-308, CAS No. 58190-62-8) 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 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), (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)(concentration 
set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), 
(iii), (iv), (vi), (vii), (viii), (ix), (g)(2)(i), (iii), (v), and 
(g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System, and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (q). It is a significant new use to 
process or use the substance involving a method that generates a vapor, 
mist, or aerosol.
    (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 as specified in Sec.  721.125(a) 
through (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.
    (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
23. Add Sec.  721.11169 to subpart E to read as follows:


Sec.  721.11169   2-Pentanone, 2,2',2''- [O,O',O''-
(methylsilylidyne)trioxime].

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance 2-pentanone, 2,2',2''- [O,O',O''-
(methylsilylidyne)trioxime] (PMN P-17-309, CAS No. 37859-55-5) 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 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), (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)(concentration 
set at 1%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1%), (f), (g)(1)(i), (iii), 
(iv), (vi), (vii), (viii), (ix), (g)(2)(i), (iii), (v), and (g)(5). 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System, and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (q). It is a significant new use to 
process or use the substance involving a method that generates a vapor, 
mist, or aerosol.
    (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 as specified in Sec.  721.125(a) 
through (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.

[[Page 49826]]

    (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
24. Add Sec.  721.11170 to subpart E to read as follows:


Sec.  721.11170   Naphthalene trisulfonic acid sodium salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
naphthalene trisulfonic acid sodium salt (P-17-321) 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), (iv), (a)(3), (a)(4), (a)(5)(respirators must 
provide a National Institute for Occupational Safety and Health 
assigned protection factor of at least 50), (when determining which 
persons are reasonable 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 exposures, 
where feasible), (b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ii), 
(iv), (ix), (g)(2)(i), (ii), (iii), (iv), (v), and (g)(5). Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q) and (t). It is a significant new use to 
manufacture, process, or use the substance in any manner that generates 
a vapor, mist, or aerosol.
    (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) 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)(iii) 
of this section.

0
25. Add Sec.  721.11171 to subpart E to read as follows:


Sec.  721.11171   Polymer of aliphatic dicarboxylic acid and dicyclo 
alkane amine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as polymer 
of aliphatic dicarboxylic acid and dicyclo alkane amine (P-17-327) 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 substance after they have 
been reacted (cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. It is a significant new use to 
manufacture (includes import) the substance to have an average 
molecular weight of greater than 10,000 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, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
26. Add Sec.  721.11172 to subpart E to read as follows:


Sec.  721.11172   Hexanedioic acid, polymer with trifunctional polyol, 
1,1'-methylenebis [isocyanatobenzene], and 2,2'-oxybis [ethanol] 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
hexanedioic acid, polymer with trifunctional polyol, 1,1'-methylenebis 
[isocyanatobenzene], and 2,2'-oxybis [ethanol] (P-17-330) 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 substance after they have been 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), (iv), (a)(3), (when determining 
which persons are reasonable 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 exposures, 
where feasible), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(i), (eye and respiratory 
irritation), (g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. It is a significant new use to 
manufacture, process, or use the substance for consumer use or for 
commercial uses that could introduce the substance into a consumer 
setting. It is a significant new use to manufacture, process, or use 
the substance in any manner that generates a dust, mist, or aerosol.
    (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) are applicable to manufacturers, importers, and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2018-21194 Filed 10-2-18; 8:45 am]
 BILLING CODE 6560-50-P