[Federal Register Volume 83, Number 192 (Wednesday, October 3, 2018)]
[Rules and Regulations]
[Pages 49806-49826]
[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

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.

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

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

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/

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

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;

    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

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

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.

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

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

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).

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

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

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

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).

    (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

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