[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)]
[Rules and Regulations]
[Pages 47004-47025]
[FR Doc No: 2018-19950]

Vol. 83

Monday,

No. 180

September 17, 2018

Part II

Environmental Protection Agency

-----------------------------------------------------------------------

40 CFR Parts 9 and 721

Significant New Use Rules on Certain Chemical Substances; Final Rule
and Proposed Rule

Federal Register / Vol. 83 , No. 180 / Monday, September 17, 2018 /
Rules and Regulations

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2018-0567; FRL-9983-14]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

-----------------------------------------------------------------------

SUMMARY: EPA is promulgating significant new use rules (SNURs) under
the Toxic Substances Control Act (TSCA) for 28 chemical substances
which were the subject of premanufacture notices (PMNs). The chemical
substances are subject to Orders issued by EPA pursuant to the TSCA.
This action requires persons who intend to manufacture (defined by
statute to include import) or process any of these 28 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 November 16, 2018. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
October 1, 2018.
    Written adverse comments on one or more of these SNURs must be
received on or before October 17, 2018 (see Unit VI. of the
SUPPLEMENTARY INFORMATION). If EPA receives written adverse comments,
on one or more of these SNURs before October 17, 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-2018-0567, 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 October 17, 2018
are subject to the export notification provisions of TSCA section 12(b)
(15 U.S.C. 2611(b)) (see Sec.  [emsp14]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 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
October 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.  [emsp14]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 28
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 28 chemical substances in 40 CFR part 721, subpart E.
In this unit, EPA provides the following information for each chemical
substance:
     PMN number.
     Chemical name (generic name, if the specific name is
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
     Basis for the TSCA section 5(e) Order.
     Information identified by EPA that would help characterize
the potential health and/or environmental effects of the chemical
substance in support of a request by the PMN submitter to modify the
Order, or if a manufacturer or processor is considering submitting a
SNUN for a significant new use designated by the SNUR.
    This information may include testing required in a TSCA section
5(e) Order to be conducted by the PMN submitter, as well as testing not
required to be conducted but which would also help characterize the
potential health and/or environmental effects of the PMN substance. Any
recommendation for information identified by EPA was made based on
EPA's consideration of available screening-level data, if any, as well
as other available information on appropriate testing for the chemical
substance. Further, any such testing identified by EPA that includes
testing on vertebrates was made after consideration of available
toxicity information, computational toxicology and bioinformatics, and
high-throughput screening methods and their prediction models. EPA also
recognizes that whether testing/further information is needed will
depend on the specific exposure and use scenario in the SNUN. EPA
encourages all SNUN submitters to contact EPA to discuss any potential
future testing. See Unit VIII. for more information.
     CFR citation assigned in the regulatory text section of
this rule.
    The regulatory text 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 28 PMN substances that are subject to Orders
under TSCA section 5(e)(1)(A). Each Order is based on one or more of
the findings in TSCA section 5(a)(3)(B): There is insufficient
information to permit a reasoned evaluation; in the absence of
sufficient information to permit a reasoned evaluation, the activities
associated with the PMN substances may present unreasonable risk to
human health or the environment; the substance is or will be produced
in substantial quantities, and enters or may reasonably be anticipated
to enter the environment in substantial quantities or there is or may
be significant (substantial) human exposure to the substance. Those
Orders require protective measures to limit exposures or otherwise
mitigate the potential unreasonable risk. The SNURs identify as
significant new uses any manufacturing, processing, use, distribution
in commerce, or disposal that does not conform to the restrictions
imposed by the underlying Orders, consistent with TSCA section 5(f)(4).
Where EPA determined that the PMN substance may present an unreasonable

risk of injury to human health via inhalation exposure, the underlying
TSCA section 5(e) 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.
[emsp14]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-14-758

    Chemical name: 2-Propenenitrile, polymer with methanamine,
hydrogenated, 3-aminopropylterminated, ethoxylated propoxylated.
    CAS number: 2055838-16-7.
    Effective date of TSCA section 5(e) Order: September 15, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as urethane foam. Based
on physical/chemical properties, EPA has identified concern for lung
toxicity. Based on SAR analysis of polycationic polymers, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
416 parts per billion (ppb). 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 human health
and the environment. To protect against these risks, the Order
requires:
    1. Refraining from manufacturing the PMN substance in the United
States (i.e. import only);
    2. Use of personal protective equipment where there is a potential
for dermal exposure;
    3. Use of a National Institute of Occupational Safety and Health
(NIOSH)-certified respirator with an APF of at least 50 where there is
a potential for inhalation exposure;
    4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS;
    5. No application method of the PMN substance that results in
greater worker inhalation exposures to vapor, mist, or aerosol than
those encountered in roller coating application;
    6. Use of the PMN substance only for the confidential uses
specified in the Order; and
    7. No release of the PMN substance into the waters of the United
States.

The SNUR designates as a ``significant new use'' the absence of these
protective measures.
    Potentially useful information: EPA has determined that certain
information about the physical-chemical properties, fate, ecotoxicity
and pulmonary 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 would be designated by this SNUR. EPA has determined that the
results of physical-chemical property testing, fate, acute and chronic
aquatic toxicity testing, and pulmonary toxicity testing would help
characterize the potential environmental and health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions will remain in effect until the Order is modified or
revoked by EPA based on submission of this or other information that
EPA determines is relevant and needed to evaluate a modification
request.
    CFR citation: 40 CFR 721.11124.

PMN Number: P-16-493

    Chemical Name: Dicarboxylic acids, polymers with alkyl prop-2-
enoate, alkyl 2- ethylprop-2-enoate, alkyl[(alkenyl)alkyl]alkanediol,
alkanediol, alkanedioic acid, alkyl 2-rnethylprop-2-enoate, alkyl prop-
2-enoic acid, alkylene [isocyanatocarbomonocyte] and alkanediol,
alkanolamine-blocked, compds with 2-(alkylamino)alkanol (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: September 18, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as paint. Based on
physical/chemical properties of the PMN substance and test data on
analogous diisocyanates, EPA identified concerns for dermal
sensitization, respiratory sensitization, lung effects, neurotoxicity,
and developmental toxicity, as well as skin irritation, and a potential
for cancer to workers due to the possibility of isocyanate residuals.
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 human health and the environment. To
protect against these risks, the Order requires:
    1. Refraining from manufacturing or processing the PMN substance in
the United States (i.e., import only);
    2. Import of the PMN substance to contain no more than 0.1%
residual isocyanate by weight; and
    3. Import of the PMN substance to contain no more than 1% of a
confidential component by weight.

The SNUR designates as a ``significant new use'' the absence of these
protective measures.
    Potentially useful information: EPA has determined that certain
information about the 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 would be designated by this SNUR. EPA has
determined that the results of sensitization and pulmonary toxicity
testing would help characterize the potential health effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions will remain in effect until the Order is modified or
revoked by EPA based on submission of this or other information that
EPA determines is relevant and needed to evaluate a modification
request.
    CFR citation: 40 CFR 721.11125.

PMN Number: P-16-514

    Chemical Name: Mixed metal oxide (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: August 7, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-

confidential) use of the substance will be as a catalyst. Based on SAR
analysis of test data on analogous mixed metal oxides, EPA identified
concerns for lung effects, systemic effects, eye irritation and
allergic skin reaction. EPA also identified risk to workers for lung
toxicity based on lung overload for respirable, poorly soluble
particulates. 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 human health.
To protect against these risks, the Order requires:
    1. Submission to EPA of certain toxicity testing before 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. Use of a NIOSH-certified respirator with an APF of at least
1,000 where there is a potential for inhalation exposure or compliance
with a NCEL of 0.04 mg/m\3\ as an 8-hour time-weighted average to
prevent inhalation exposure;
    4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the Safety Data Sheet (SDS);
    5. Refraining from manufacturing or processing the PMN substance in
the United States (i.e., import only);
    6. Use of the PMN substance only for the confidential use stated in
the Order; and
    7. Disposal of the PMN substance only by recycling 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 would be designated by this SNUR. The
submitter has agreed not to exceed a certain production volume limit
without performing specific pulmonary and internal organ toxicity
testing.
    CFR citation: 40 CFR 721.11126.

PMN Numbers: P-16-576 and P-16-577

    Chemical names: Modified alkyl polyamine (generic) (P-16-576) and
alkyl polyamine (generic) (P-16-577).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: September 18, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the substances will be as an intermediate (P-
16-576) and an oil lubricant additive (P-16-577). Based on the
physical/chemical properties of the PMN substances, analogue toxicity
data, and data on the PMN substances, EPA has identified concerns for
irritation to the skin, eyes, mucous membranes, and lungs; effects to
the GI tract, adrenal glands, and blood; immunotoxicity; and
reproductive toxicity. Based on Structure Activity Relationship (SAR)
predictions for polycationic polymers and aliphatic amines, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 2 parts per billion. 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 human health
and the environment. To protect against these risks, the Order
requires:
    1. Use of the PMN substances only for the confidential uses stated
in the Order;
    2. Use of personal protective equipment where there is a potential
for dermal exposure;
    3. Submission to EPA of certain toxicity testing for P-16-577 no
later than 9 months and 12 months from the date of the Notice of
Commencement (NOC) of either substance;
    4. Refraining from manufacture, processing or use for consumer use
or in commercial use where there is use in a consumer setting; and
    5. No release of P-16-577 resulting in surface water concentrations
that exceed 2 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
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 would be designated by this SNUR.
The submitter has agreed not to exceed certain time limits without
performing specific pharmacokinetic and developmental toxicity testing.
Additionally, EPA has determined that the results of chronic aquatic
toxicity testing on P-16-577 would help characterize the potential
environmental effects caused by the PMN substances. 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 information that EPA determines is relevant
and needed to evaluate a modification request.
    CFR citations: 40 CFR 721.11127 (P-16-576) and 40 CFR 721.11128 (P-
16-577).

PMN Number: P-16-590

    Chemical Name: Silica gel, reaction products with chromium oxide
(CrO3) and ethoxydiethyl aluminum.
    CAS Number: 932384-12-8.
    Effective date of TSCA section 5(e) Order: September 13, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of
the substance will be as a catalyst for polyethylene polymerization.
Based on the reactivity of the PMN substance and the presence of
chromium VI, EPA identified concerns for oncogenicity, reproductive
toxicity, respiratory sensitization, and severe irritation to skin,
eyes, lung and mucous membranes. 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. To protect against these risks, the Order requires:
    1. Handling the PMN substance under an inert atmosphere using
containers and systems designed not to be exposed to the air;
    2. Use of personal protective equipment where there is a potential
for dermal exposure;
    3. Use of a NIOSH-certified respirator with an APF of 10 to 1,000
depending on monitoring results from the methods required in the Order;
and
    4. Disposal of all waste streams containing the PMN substance and
the constituent breakdown products of the PMN substance in a Resource
Conservation and Recovery Act (RCRA) hazardous waste landfill.

The SNUR designates as a ``significant new use'' the absence of these
protective measures.
    Potentially useful information: EPA has determined that certain
information about the 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 would be designated by this SNUR. EPA has
determined that the results of a pulmonary toxicity study and a
carcinogenicity study would help characterize the potential health
effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions will remain in effect until the Order
is modified or revoked by EPA based on submission of this or other
relevant information.
    CFR citation: 40 CFR 721.11129.

PMN Number: P-16-593

    Chemical Name: Carboxylic acids, C6-18 and C5-15-di-, polymers with
diethyleneglycol, glycerol, sorbitol and terephthalic acid.
    CAS Number: 1967778-37-5.
    Effective date of TSCA section 5(e) Order: August 7, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of
the substance will be as an aromatic polyester polyol for rigid foam.
EPA identified concerns for lung effects and irritation to the eyes and
mucous membranes based on the physical/chemical properties of the PMN
substance. 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 human 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 the PMN substance only as an aromatic polyester polyol
for rigid foam;
    3. No manufacture, processing, or use of the PMN substance to
result in inhalation exposures to a vapor, mist or aerosol; 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.
    Potentially useful information: EPA has determined that certain
information about the physical-chemical properties 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 would be
designated by this SNUR. EPA has determined that the results of
physical-chemical property testing and pulmonary toxicity 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 721.11130.

PMN Number: P-17-5

    Chemical name: 1-tetradecene homopolymer hydrogenated.
    CAS number: 1857296-89-9.
    Effective date of TSCA section 5(e) Order: August 9, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of
the substance will be as a base fluid/carrier fluid for additives in
motor oil, automatic transmission fluid, and industrial lubricants.
Based on analysis of test data on an analogous chemical substance, EPA
has identified concerns for irritation to mucous membranes and
hydrocarbon pneumonia. The Order was issued under TSCA section
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 human health.
The Order was also issued under TSCA section 5(a)(3)(B)(ii)(II) and
5(e)(1)(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 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. Submission to EPA of certain toxicity testing no later than 9
months after the NOC;
    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 to
result in inhalation exposure to a vapor, mist, or aerosol; and
    4. Not process the PMN substance for use other than as a base
fluid/carrier fluid for additives in motor oil, automatic transmission
fluid, and industrial lubricants.

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 would be designated by this SNUR. The
submitter has agreed not to exceed a certain production volume limit
without performing specific pulmonary toxicity testing.
    CFR citation: 40 CFR 721.11131.

PMN Numbers: P-17-149, P-17-150, P-17-151, and P-17-165

    Chemical Name: Fluorocyanophenyl alkylbenzoate (generic)
    CAS Numbers: Not available.
    Effective date of TSCA section 5(e) Order: August 10, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substances will be for electronic device
use. Based on analysis of test data on analogous chemicals, EPA
identified concerns for reproductive toxicity, developmental toxicity,
neurotoxicity, and lung and skin effects. Based on SAR analysis of test
data on analogous esters, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 2 ppb for P-17-165 and 4 ppb
for the other PMN substances. 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
substances 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 toxicity testing before 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. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS;
    4. Use of the PMN substances only for the confidential use
specified in the Order;
    5. No modification of the manufacture, processing or use of the PMN
substances to result in inhalation exposure to vapor, dust, mist, or
aerosol; and
    6. No release of the PMN substances resulting in surface water
concentrations that exceed 2 ppb for P-17-165 and 4 ppb for the other
PMN substances.

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
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 would be designated by this SNUR.
The submitter has agreed not to exceed a certain production volume
limit without performing specific reproductive/developmental toxicity
testing and acute and chronic aquatic toxicity testing.
    CFR citation: 40 CFR 721.11132.

PMN Number: P-17-175

    Chemical Name: Fluorinated propenoic poly alkyl ether ester
(generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: September 1, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of
the PMN substance will be as a leveling agent for coatings applied to
aluminum printing plates. Based on analysis of test data on the
analogue perfluorohexanoic acid, EPA identified concerns for liver
toxicity, blood toxicity, and male reproductive toxicity for the
potential incomplete incineration product. Based on SAR predictions for
polyanionic polymers for the potential degradation product, EPA also
identified concern for effects of the potential degradation products to
terrestrial wild animals and birds based on test data for analogous
perfluoro chemicals in mammals. EPA has concerns that these degradation
products will persist in the environment, could bioaccumulate or
biomagnify, and could be toxic (PBT) to people, wild mammals, and
birds. 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 human health and the environment. To
protect against these risks, the Order requires:
    1. Refraining from domestic manufacture in the United States (i.e.,
import only);
    2. No manufacture (including import) beyond a maximum annual
production volume of 60 kg; and
    3. Use of the PMN substance only as a leveling agent for coatings
applied to aluminum printing plates.

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 physical-chemical properties and fate 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 would be designated by this SNUR.
EPA has determined that the results of specific physical-chemical
properties, environmental fate, and bioaccumulation testing would help
characterize the potential health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions will remain in effect until the Order is modified or
revoked by EPA based on submission of this or other relevant
information.
    CFR citation: 40 CFR 721.11133.

PMN number: P-17-199

    Chemical name: Oxyalkylene urethane polyolefin (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: September 14, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of
the substance will be as a binder in sealant. Based on the physical/
chemical properties of the PMN substance, EPA identified concerns for
oncogenicity, male reproductive effects, developmental toxicity and
sensitization if the PMN substance were manufactured differently. 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 human health. To protect against
these risks, the Order requires:
    1. Manufacture of the PMN substance at no less than the average
molecular weight specified in the Order; and
    2. Manufacture of the PMN substance with no more than 1% of the
molecular weight content below 1,000 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 would be designated by this SNUR. EPA has
determined that the results of specific developmental toxicity,
internal organ toxicity, and sensitization 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 721.11134.

PMN Number: P-17-206

    Chemical Name: Imino alkane amine phosphate (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: August 9, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as a flame retardant
for textiles. EPA identified concerns for irritation to eyes, mucous
membranes, and lungs based on the pH of the PMN substance being 5. Also
based on SAR analysis of test data on the nearest analogue inorganic
phosphates EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 2 ppb. 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
human health and the environment. To protect against these risks, the
Order requires:
    1. Refraining from domestic manufacture in the United States (i.e.,
import only);
    2. Use of personal protective equipment where there is a potential
for dermal exposure;
    3. No modification of the processing or use of the PMN substance to
result in inhalation exposures to vapor, dust, mist, or aerosol;
    4. Use of the PMN substance only for the confidential use specified
in the Order;
    5. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS;
    6. No release of the PMN substance into the waters of the United
States; and
    7. Disposal of the PMN substance and waste streams containing the
PMN substance by incineration.

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 effects of the PMN substance may be
potentially useful 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 would be
designated by this SNUR. EPA has determined that the results of
specific 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 citations: 40 CFR 721.11135 (P-17-206).

PMN Number: P-17-223

    Chemical Name: Fatty acids, tall-oil, reaction products with 2-[(2-
aminoalkyl)amino]alkanol, compds. with alkylene oxide-glycidyl o-tolyl
ether polymer dihydrogenphosphate alkyl ether (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: September 12, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as an additive for
open, non-dispersive use. EPA identified concerns for developmental
toxicity based on N-heterocyclic compounds and concerns for possible
irritation to mucous membranes and lung toxicity based on potential
surfactancy properties. Also based on SAR analysis of test data on
nearest analogue of soluble forms of inorganic phosphates, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
15 ppb. 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 human health and the environment. To
protect against these risks, the Order requires:
    1. Submission to EPA of certain toxicity testing before exceeding
the confidential production volume limit specified in the Order;
    2. Refraining from manufacture, processing, or use for consumer use
or in commercial use where there is use in a consumer setting;
    3. Refrain from domestic manufacture in the United States (i.e.,
import only);
    4. Use of the PMN substance only for the confidential use specified
in the Order;
    5. Use of the PMN substance in the confidential formulation at a
concentration not greater than 1 percent by weight or volume;
    6. Use of personal protective equipment where there is a potential
for dermal exposure;
    7. Refraining from modifying the processing if such modification
would result in inhalation exposures to the PMN substance by vapor,
dust, mist, or aerosol at a concentration of greater than 1 percent by
weight or volume;
    8. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS; and
    9. No release of the PMN substance resulting in surface water
concentrations that exceed 15 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 physical-chemical properties, environmental
effects, and health effects of the PMN substance may be potentially
useful 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 would be designated by this SNUR.
The submitter has agreed not to exceed a certain production volume
limit without performing specific reproductive/developmental toxicity
testing and acute aquatic toxicity testing. EPA has also determined
that the results of specific physical-chemical property and pulmonary
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 721.11136.

PMN Number: P-17-230

    Chemical Name: Oxirane, 2-alkyl-, polymer with oxirane, mono[N-[3-
(carboxyamino)-4(or 6)-alkylphenyl]carbamate], alkyl ether, ester with
2,2',2''-nitrilotris-[alkanol] (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: September 12, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as an additive for
open, non-dispersive use. Based on the potential surfactant properties,
cationic binding to lung tissues, EPA identified concerns for lung
toxicity and skin irritation. Based SAR analysis of test data on
analogous polycationic polymers, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 65 parts per billion.
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 human health and the environment. To
protect against these risks, the Order requires:
    1. Submission to EPA of certain toxicity testing before exceeding
the confidential production volume limit specified in the Order;
    2. Refraining from manufacture, processing, or use for consumer use
or in commercial use where there is use in a consumer setting;
    3. Refraining from domestic manufacture in the United States (i.e.,
import only);
    4. Use of the PMN substance only for the confidential use specified
in the Order;
    5. Use of the PMN substance in the confidential formulation at a
concentration not greater than 1 percent by weight or volume;
    6. Use of personal protective equipment where there is a potential
for dermal exposure;
    7. Refraining from modifying the processing method if such
modification would result in inhalation exposures to the PMN substance
by vapor, dust, mist, or aerosol, at a concentration of greater than 1
percent by weight or volume;
    8. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS; and
    9. No release of the PMN substance resulting in surface water
concentrations that exceed 65 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 physical-chemical properties, environmental
effects, and health effects of the PMN substance may be potentially
useful 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 would be designated by this SNUR.
The submitter has agreed not to exceed a certain production volume
limit without performing specific acute aquatic and sediment toxicity
testing. EPA has also determined that the results of specific physical-
chemical property and pulmonary toxicity testing would help
characterize the potential health effects of the PMN substance.
Although the

Order does not require these tests, the Order's restrictions will
remain in effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
    CFR citation: 40 CFR 721.11137.

PMN Number: P-17-236

    Chemical Name: Formaldehyde, polymer with (chloromethyl) oxirane
and substituted aromatic compounds (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: September 11, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as matrix resin for
composite materials and binder resin for electronic materials. Based on
analysis of test data on the PMN substance, analysis of data on
analogous chemicals, and on the epoxide chemical category of concern,
EPA identified concerns for skin and lung sensitization, oncogenicity,
developmental toxicity, and male reproductive 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. To protect against these risks, the Order
requires:
    1. Submission to EPA of certain toxicity testing before 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. 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 in the United States (i.e.,
import only);
    5. Use of the PMN substance only as described in the PMN; and
    6. No manufacture, processing, or use that results in inhalation
exposure to vapor, dust, 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 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 would be designated by
this SNUR. The submitter has agreed not to exceed a certain production
volume limit without performing sensitization testing. EPA has also
determined that the results of specific internal organ toxicity and
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 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 721.11138.

PMN numbers: P-17-241, P-17-242, P-17-243, P-17-244

    Chemical names: Acid, reaction products with cadmium selenide
(CdSe), trioctylphosphine and trioctylphosphine oxide (generic) (P-17-
241), Acid, reaction products with cadmium selenide sulfide, acid,
trioctylphosphine and trioctylphosphine oxide (generic) (P-17-242),
Acid, reaction products with cadmium metal selenide sulfide,
trioctylphosphine and trioctylphosphine oxide (generic) (P-17-243),
Metal oxide reaction products with cadmium metal selenide sulfide, and
amine (generic) (P-17-244).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: September 20, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of P-17-241, P-17-242, and P-17-243 will be as
chemical intermediates, and the specific use of P-17-244 will be as a
down converting phosphor particle for use in conjunction with
optoelectronic components. Based on analogy to respirable poor soluble
particulates and the presence of cadmium, EPA identified concerns for
lung effects, kidney effects, and oncogenicity for the PMN substances.
EPA also identified concerns for neurotoxicity, developmental toxicity,
and kidney toxicity for PMN P-17-244 based on the presence of other
chemicals. Based on analysis of test data for cadmium and selenium core
components, there is high hazard for acute and chronic environmental
toxicity for PMNs P-17-241, P-17-242, and P-17-243. There is potential
chronic environmental toxicity for PMN P-17-244 based on the presence
of cadmium. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I)
and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of
sufficient information to permit a reasoned evaluation the substances
may present an unreasonable risk of injury to health and the
environment. To protect against these risks, the Order requires:
    1. Submission to EPA of certain testing for P-17-244 before
exceeding the confidential production volume limit specified in the
Order;
    2. Use of personal protective equipment where there is potential
for dermal exposure;
    3. Manufacture, processing, and use P-17-241, P-17-242, and P-17-
243 only as chemical intermediates as required in the Order;
    4. Manufacture, processing, and use P-17-241, P-17-242, and P-17-
243 only in liquid formulations;
    5. No use of P-17-241, P-17-242, and P-17-243 in applications that
generate a dust, mist, or aerosol;
    6. Manufacture, processing and use of P-17-244, only as a down-
converter for use in conjunction with optoelectronic components;
    7. For workers potentially exposed to the solid form of P-17-244,
use of a laminar-flow fume hood or glove box to reduce or eliminate
inhalation exposure, and workers who may still be exposed by inhalation
will use a NIOSH-certified full-faced respirator with an APF of at
least 50; and
    8. Disposal of the PMN substances only by incineration in a
permitted hazardous waste incinerator.

The SNUR designates as a ``significant new use'' the absence of these
protective measures.
    Potentially useful information: EPA has determined that certain
information about the fate and health effects of the PMN substances may
be potentially useful 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 would be designated by
this SNUR. The submitter has agreed not to exceed a certain production
volume limit without performing certain fate and internal organ
toxicity testing on P-17-244. EPA has also determined that the results
of specific fate testing would help characterize the potential health
and environmental effects of the PMN substances. Although the Order
does not require these tests, the Order's restrictions will remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
    CFR citations: 40 CFR.11139 (P-17-241), 40 CFR.11140 (P-17-242), 40
CFR.11141 (P-17-243), and 40 CFR.11142 (P-17-244).

PMN number: P-17-265

    Chemical name: Alkanoic acid, 2-alkyl-, substituted alkyl ester,
polymer with alkyl alkenoate, substituted carbomonocycle, substituted
alkyl

alkenoate and alkyl substituted alkenoate, substituted alkanenitrile-
initiated (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: August 16, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of
the substance will be as a coating resin intermediate. Based on
physical/chemical properties EPA identified concerns for lung toxicity,
systemic toxicity, reproductive toxicity, corrosion, and irritation for
the PMN substance when it has an acid concentration greater than 20% or
an amine concentration greater than 5%. Based on SAR analysis for
anionic polymers and physical/chemical properties, EPA has identified
concern for environmental effects when it has an acid concentration
greater than 20%. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation the
substance may present an unreasonable risk of injury to health and the
environment. To protect against these risks, the Order requires:
    1. Refraining from manufacturing the PMN substance with an acid
concentration greater than 20%; and
    2. Refraining from manufacturing the PMN substance with an amine
concentration greater than 5%.

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 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 would be
designated by this SNUR. EPA has determined that the results of
specific physical-chemical property testing, pulmonary toxicity
testing, irritation testing, and acute and chronic aquatic toxicity
testing would help characterize the potential health and environmental
effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions will remain in effect until the Order
is modified or revoked by EPA based on submission of this or other
relevant information.
    CFR citation: 40 CFR 721.11143.

PMN number: P-17-301

    Chemical name: Manganese heterocyclic-amine carboxylate complexes
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: September 22, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
use of the PMN substance will be as a surface drier in clear and
pigmented coatings systems. Based on the physical/chemical properties
of the PMN substance and analysis of analogue test data, EPA identified
concerns for neurotoxicity, developmental toxicity, and eye and skin
irritation. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I)
and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of
sufficient information to permit a reasoned evaluation the substance
may present an unreasonable risk of injury to health and the
environment. 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 is or will be produced in substantial quantities and that the
substance either enters or may reasonably be anticipated to enter the
environment in substantial quantities. To protect against these risks,
the Order requires:
    1. Submission to EPA of certain testing before exceeding an
aggregate total production of 430,000 kilograms of the PMN substance;
    2. Use of personal protective equipment where there is a potential
for dermal exposure;
    3. Use of a NIOSH-certified respirator with an APF of at least 10
where there is potential for inhalation exposure;
    4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS; and
    5. No use of the PMN substance other than as a surface drier in
clear and pigmented coatings systems.

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 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 would be designated by
this SNUR. The submitter has agreed not to exceed the production limit
without performing specific reproductive/developmental toxicity
testing.
    CFR citation: 40 CFR 721.11144.

PMN number: P-17-318

    Chemical name: Sulfuric acid mixed salt (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: September 25, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as a component in
nutrient solutions. Based on analogue data and information provided in
the SDS, EPA has identified concerns for skin, eye, respiratory, and GI
tract irritation, corrosion and acute toxicity. Also, based on SAR
predictions for analogue inorganic salts, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 760 ppb. 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 human 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 substance is or will be
produced in substantial quantities and that the substance either enters
or may reasonably be anticipated to enter the environment in
substantial quantities. To protect against these risks, the Order
requires:
    1. Submission of certain toxicity testing on the PMN substance
prior to exceeding the confidential production volume limit specified
in the Order.
    2. Use of personal protective equipment where there is a potential
for dermal exposure.
    3. Use of the PMN substance only for the confidential use specified
in the Order.
    4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    5. Manufacture of the PMN substance to contain no more than 1% free
ammonia.

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 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 would be
designated by this SNUR. The submitter has agreed not to exceed the
production limit without performing specific acute aquatic toxicity
testing. EPA has also determined that the results of specific
reproductive/developmental toxicity testing would help characterize the
potential health and environmental

effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions will remain in effect until the Order
is modified or revoked by EPA based on submission of this or other
relevant information.
    CFR citation: 40 CFR 721.11145.

PMN number: P-17-323

    Chemical name: 2-Propenoic acid, branched alkyl ester (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: September 26, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the use of
the substance will be as a reactive monomer for use in producing
polymers. Based on the 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 estimates that the PMN
substance will persist in the environment more than 2 months and
estimates a bioaccumulation factor of greater than or equal to 1,000.
Based on SAR analysis of test data on analogous acrylates and from the
branched acid that may be formed after ester hydrolysis, EPA has
identified concerns for eye and skin irritation, oncogenicity,
developmental toxicity, liver toxicity, kidney toxicity, and
sensitization. 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 human health
and the environment. To protect against these risks, the Order
requires:
    1. Submission of certain toxicity testing on the PMN substance
prior to exceeding the confidential production volume limit as
specified in the Order;
    2. Use of personal protective equipment where there is a potential
for dermal exposure;
    3. No use of the PMN substance other than as a reactive monomer for
use in producing polymers;
    4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS;
    5. Refraining from domestic manufacture in the United States (i.e.,
import only); and
    6. No release of the PMN substance to the waters of the United
States.

The SNUR designates as a ``significant new use'' the absence of these
protective measures.
    Potentially useful information: EPA has determined that certain
information about the health effects of the PMN substance may be
potentially useful 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 would be designated by
this SNUR. The submitter has agreed not to exceed the production limit
without performing specific developmental/reproductive toxicity and
sensitization testing. EPA has also determined that the results of
specific fate testing would help characterize the potential health
effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions will remain in effect until the Order
is modified or revoked by EPA based on submission of this or other
relevant information.
    CFR citation: 40 CFR 721.11146.

PMN number: P-17-326

    Chemical name: Allyloxymethylacrylate (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: September 5, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as an ultraviolet
curable monomer. Based on analysis of test data on the PMN substance
and the physical/chemical properties of the PMN substance, EPA
identified concerns for oncogenicity, developmental and reproductive
effects, liver and kidney toxicity, sensitization, and irritation.
Additionally, the SDS indicates concerns for severe skin and eye damage
and allergic skin reaction. Based on analysis of acute aquatic toxicity
data, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 26 ppb. 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 risk, the Order
requires:
    1. Submission of certain toxicity 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 potential
for dermal exposure;
    3. Use of NIOSH certified respirators with an APF of 10 to prevent
inhalation exposure where there is potential for inhalation exposure;
    4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS;
    5. Refraining from domestic manufacture in the United States (i.e.,
import only);
    6. Use of the PMN substance only as specified in the Order; and
    7. No release of the PMN substance into the waters of the United
States.

The SNUR designates as a ``significant new use'' the absence of these
protective measures.
    Potentially useful information: EPA has determined that certain
information about the health and environmental effects of the PMN
substance may be potentially useful 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 would be
designated by this SNUR. The submitter has agreed not to exceed the
production limit without performing specific developmental/reproductive
toxicity and sensitization testing. EPA has also determined that the
results of specific chronic 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 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 721.11147.

PMN number: P-17-345

    Chemical name: Polyurethane, methacrylate blocked (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: September 6, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as a resin
intermediate. Based on physical/chemical properties of the PMN
substance, EPA identified concerns for irritation to skin, eye, lung,
mucous membranes, and potential neurotoxicity. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation the substance may present an unreasonable risk of
injury to health and the environment. To protect against these risks,
the Order requires:
    1. Submission of certain toxicity testing within six months from
the date of the NOC;
    2. Use of personal protective equipment where there is potential
for dermal exposure;

    3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and SDS;
    4. No manufacturing, processing, or use of the PMN substance in a
manner that would result in inhalation exposure to vapor, mist,
aerosol, or dust; and
    5. Use the PMN substance only as 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 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 would be designated by
this SNUR. The submitter has agreed not to exceed the production limit
without performing specific eye irritation testing.
    CFR citation: 40 CFR 721.11148.

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

B. Objectives

    EPA is issuing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this rule:
     EPA will receive notice of any person's intent to
manufacture or process a listed chemical substance for the described
significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
     EPA will be able to either determine that the prospective
manufacture or processing is not likely to present an unreasonable
risk, or to take necessary regulatory action associated with any other
determination, before the described significant new use of the chemical
substance occurs.
     EPA will identify as significant new uses any
manufacturing, processing, use, 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 November 16, 2018 without further notice, unless
EPA receives written adverse comments before October 17, 2018.
    If EPA receives written adverse comments on one or more of these
SNURs before October 17, 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 an
NOC and the chemical substance has not been added to the TSCA
Inventory, no person may commence such activities without first
submitting a PMN. Therefore, for chemical substances for which an NOC
has not been submitted EPA concludes that the designated significant
new uses are not ongoing.
    When chemical substances identified in this rule are added to the
TSCA Inventory, EPA recognizes that, before the rule is effective,
other persons might engage in a use that has been identified as a
significant new use. However, TSCA section 5(e) Orders have been issued
for all of the chemical substances, and the PMN submitters are
prohibited by the TSCA section 5(e) Orders from undertaking activities
which will be designated as significant new uses. The identities of 24
of the 28 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 September 17, 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). To
access the OCSPP test guidelines referenced in this document
electronically, please go to http://www.epa.gov/ocspp and select ``Test
Methods and Guidelines.'' The Organisation for Economic Co-operation
and Development (OECD) test guidelines are available from the OECD
Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.
    In certain of the TSCA section 5(e) Orders for the chemical
substances regulated under this rule, EPA has established production
volume limits in view of the lack of data on the potential health and
environmental risks that may be posed by the significant new uses or
increased exposure to the chemical substances. These limits cannot be
exceeded unless the PMN submitter first submits the results of toxicity
tests that would permit a reasoned evaluation of the potential risks
posed by these chemical substances. Listings of the tests specified in
the TSCA section 5(e) Orders are included in Unit IV. The SNURs contain
the same production volume limits as the TSCA section 5(e) Orders.
Exceeding these production limits is defined as a significant new use.
Persons who intend to exceed the production limit must notify the
Agency by submitting a SNUN at least 90 days in advance of commencement
of non-exempt commercial manufacture or processing.
    Any request by EPA for the triggered and pended testing described
in the Orders was made based on EPA's consideration of available
screening-level data, if any, as well as other available information on
appropriate testing for the PMN substances. Further, any such testing
request on the part of EPA that includes testing on vertebrates was
made after consideration of available toxicity information,
computational toxicology and bioinformatics, and high-throughput
screening methods and their prediction models.
    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.
[emsp14]721.1725(b)(1) with that under Sec.  [emsp14]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.  [emsp14]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 Sec.  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-2018-0567.

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, or TSCA section 5(e) Orders. The Office
of Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40

of the CFR, after appearing in the Federal Register, are listed in 40
CFR part 9, and included on the related collection instrument or form,
if applicable. EPA is amending the table in 40 CFR part 9 to list the
OMB approval number for the information collection requirements
contained in this action. This listing of the OMB control numbers and
their subsequent codification in the CFR satisfies the display
requirements of PRA and OMB's implementing regulations at 5 CFR part
1320. This Information Collection Request (ICR) was previously subject
to public notice and comment prior to OMB approval, and given the
technical nature of the table, EPA finds that further notice and
comment to amend it is unnecessary. As a result, EPA finds that there
is ``good cause'' under section 553(b)(3)(B) of the Administrative
Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without
further notice and comment.
    The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
    Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.

C. Regulatory Flexibility Act (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b)
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a
significant economic impact on a substantial number of small entities
where the following are true:
    1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
    2. The SNUR submitted by any small entity would not cost
significantly more than $8,300.
    A copy of that certification is available in the docket for this
action.
    This action is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit XI. and
EPA's experience promulgating SNURs (discussed in the certification),
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
     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 5, 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.  14;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

------------------------------------------------------------------------
                                * * * * *
721.11124...............................................       2070-0012
721.11125...............................................       2070-0012
721.11126...............................................       2070-0012
721.11127...............................................       2070-0012
721.11128...............................................       2070-0012
721.11129...............................................       2070-0012
721.11130...............................................       2070-0012
721.11131...............................................       2070-0012
721.11132...............................................       2070-0012
721.11133...............................................       2070-0012
721.11134...............................................       2070-0012
721.11135...............................................       2070-0012
721.11136...............................................       2070-0012
721.11137...............................................       2070-0012
721.11138...............................................       2070-0012
721.11139...............................................       2070-0012
721.11140...............................................       2070-0012
721.11141...............................................       2070-0012
721.11142...............................................       2070-0012
721.11143...............................................       2070-0012
721.11144...............................................       2070-0012
721.11145...............................................       2070-0012
721.11146...............................................       2070-0012
721.11147...............................................       2070-0012
721.11148...............................................       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.  14;721.11124 to subpart E to read as follows:

Sec.  721.11124  2-Propenenitrile, polymer with methanamine,
hydrogenated, 3-aminopropylterminated, ethoxylated propoxylated.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-Propenenitrile,
polymer with methanamine, hydrogenated, 3-aminopropylterminated,
ethoxylated propoxylated (PMN P-14-758; CAS No. 2055838-16-7) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the PMN substance after they have
been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3) through (5) (respirators must provide a
National Institute for Occupational Safety and Health assigned
protection factor of at least 50), and (a)(6)(v), (particulate), (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 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), Sec.  721.63(b) (concentration set at 1.0%),
and Sec.  721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e) (concentration set at 1.0%), (f),
(g)(1)(ii), (g)(2)(ii), (g)(4)(iii), 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). A significant new use is any
spray application method that results in greater worker inhalation
exposures to vapor, mist, or aerosol than the roller coating
application.
    (iv) Release to water. Requirements as specified in Sec.
721.90(b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

0
5. Add Sec.  14;721.11125 to subpart E to read as follows:

Sec.  721.11125  Dicarboxylic acids, polymers with alkyl prop-2-enoate,
alkyl 2-ethylprop-2-enoate, alkyl[(alkenyl)alkyl]alkanediol,
alkanediol, alkanedioic acid, alkyl 2-rnethylprop-2-enoate, alkyl prop-
2-enoic acid, alkylene [isocyanatocarbomonocyte] and alkanediol,
alkanolamine-blocked, compds with 2-(alkylamino)alkanol (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
dicarboxylic acids, polymers with alkyl prop-2-enoate, alkyl 2-
ethylprop-2-enoate, alkyl[(alkenyl)alkyl]alkanediol, alkanediol,
alkanedioic acid, alkyl 2-methylprop-2-enoate, alkyl prop-2-enoic acid,
alkylene [isocyanatocarbomonocyte] and alkanediol, alkanolamine-
blocked, compds with 2-(alkylamino)alkanol (P-16-493) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been reacted
(cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f). It is a significant new use to import
the PMN substance to contain more than 0.1% residual isocyanate by
weight. It is a significant new use to import the PMN substance to
contain more than 1% of a confidential component by weight.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.

0
6. Add Sec.  721.11126 to subpart E to read as follows:

Sec.  721.11126  Mixed metal oxide (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as a mixed
metal oxide (P-16-514) 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) through (5) (respirators must provide a National
Institute for Occupational Safety and Health assigned protection factor
of at least 1,000), and (a)(6) (particulate), (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 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), Sec.  721.63(b) (concentration set at 1.0%), and Sec.
721.63(c).
    (A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) Order for this substance. The NCEL is 0.04 mg/m\3\ as
an 8-hour time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec.  721.63 respirator requirements may request to do
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
section 5(e) Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iv),
(lung toxicity if inhaled), (eye irritation), (allergic skin reaction),
(g)(2)(i) through (iii) and (v) (use respiratory protection or maintain
workplace airborne concentrations at or below an 8-hour time-weighted
average of 0.04 mg/m\3\), (g)(4)(i), 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(e), (f), (k), and (q).
    (iv) Disposal. Requirements as specified in Sec.  721.85. It is a
significant new use to dispose of the PMN substance other than by
recycling as described in the Order.
    (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 (j) 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 paragraphs (a)(2)(iii)
and (iv) of this section.

0
7. Add Sec.  721.11127 to subpart E to read as follows:

Sec.  721.11127  Modified alkyl polyamine (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
modified alkyl polyamine (PMN P-16-576) 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) and (iii), (a)(3), and (a)(6) (particulate),
(vapor), (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), Sec.  721.63(b) (concentration set at 1.0%),
and Sec.  721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(ii), (vi), (viii), (g)(2)(i) through (iii) and (v), (g)(3)(i) and
(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 the chemical substance more than 9 months.
    (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.
    (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
8. Add Sec.  721.11128 to subpart E to read as follows:

Sec.  721.11128  Alkyl polyamine (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as alkyl
polyamine (PMN P-16-577) 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), (a)(3), (a)(6)(v), (a)(6) (particulate),
(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), Sec.  721.63(b) (concentration set at 1.0%),
and Sec.  721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(ii), (vi), (viii), (g)(2)(i) through (iii) and (v), (g)(3)(i) and
(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 the chemical substance more than 9 months.
    (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 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.  721.11129 to subpart E to read as follows:

Sec.  721.11129  Silica gel, reaction products with chromium oxide
(CrO3) and ethoxydiethyl aluminum.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as silica gel,
reaction products with chromium oxide (CrO3) and ethoxydiethyl aluminum
is (P-16-590, CAS No. 932384-12-8) 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) and (a)(3) through (5) (respirators must provide a
National Institute for Occupational Safety and Health assigned
protection factor of 10 to 1,000 depending on the results of the
exposure monitoring as described in the Order for P16-590 and required
by this section (a)(2)(i), (a)(6) (particulate), and (a)(6) (vapor),
(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 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), Sec.  721.63(b) (concentration set at 0.1%),
and Sec.  721.63(c). It is a significant new use to not conduct the
exposure monitoring required in the Order for P16-590 when workers are
reasonably likely to be exposed by inhalation.
    (ii) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec.  721.80. It is a significant new use to
manufacture, process, or use the PMN substance other than in a system
where the PMN substance is handled in an inert atmosphere and is not
designed to be exposed to air.
    (iii) Disposal. Requirements as specified in Sec.  721.85. It is a
significant new use to dispose of all waste streams containing the PMN
substance and the constituent breakdown products of the PMN substance
other than in a Resource Conservation and Recovery Act hazardous waste
landfill.
    (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 (j) 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
10. Add Sec.  14;721.11130 to subpart E to read as follows:

Sec.  721.11130  Carboxylic acids, C6-18 and C5-15-di-, polymers with
diethylene glycol, glycerol, sorbitol and terephthalic acid.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as carboxylic acids,
C6-18 and C5-15-di-, polymers with diethylene glycol, glycerol,
sorbitol and terephthalic acid (P-16-593, CAS No. 1967778-37-5) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been 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) and (iii), and (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 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), Sec.  721.63(b) (concentration set at 1.0%), and Sec.
721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii),
(irritation), (g)(2)(i) through (iii) and (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)(aromatic polyester polyol for rigid
foam). It is a significant new use to manufacture, process, or use the
PMN substance to result in inhalation exposure to 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.
    (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
11. Add Sec.  14;721.11131 to subpart E to read as follows:

Sec.  721.11131   1-tetradecene homopolymer hydrogenated.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-tetradecene
homopolymer hydrogenated (PMN P-17-5, CAS No. 1857296-89-9) 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 1.0%), (f), (g)(1)(ii),
(g)(2)(ii), and (g)(5). Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k)(base fluid/carrier fluid for additives
in motor oil, automatic transmission fluid, and industrial lubricants).
It is a significant new use to manufacture the chemical substance more
than 9 months. It is a significant new use to manufacture, process, or
use the PMN substance to resuls in inhalation exposure to 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 (c) and (f) 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
12. Add Sec.  14;721.11132 to subpart E to read as follows:

Sec.  721.11132   Fluorocyanophenyl alkylbenzoate (generic)

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances generically identified as
fluorocyanophenyl alkylbenzoate (P-17-149), (P-17-150), (P-17-151), and
(P-17-165) are subject

to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), and (a)(6)(v),
(particulate), (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 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), Sec.  721.63(b) (concentration set at 1.0%)
and Sec.  721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i)
through (iii), (iv), (vi), and (ix), (g)(2)(i), (ii), (iii), and (v),
(g)(3)(i) and (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) and (q). It is a significant new use to
manufacture, process, or use the PMN substance to result in inhalation
exposures to vapor, dust, mist, or aerosols to the substance.
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 2 for P-17-165 and N = 4 for
P-17-149, P-17-150, and P-17-151.
    (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 these substances.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

0
13. Add Sec.  14;721.11133 to subpart E to read as follows:

Sec.  721.11133   Fluorinated propenoic poly alkyl ether ester
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
fluorinated propenoic poly alkyl ether ester (P-17-175) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been reacted
(cured).
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f) and (t)(60 kilograms). It is a
significant new use to use the substance other than as a leveling agent
for coatings applied to aluminum printing plates.
    (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 significant new use rule.

0
14. Add Sec.  14;721.11134 to subpart E to read as follows:

Sec.  721.11134   Oxyalkylene urethane polyolefin (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
oxyalkylene urethane polyolefin (PMN P-17-199) 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 new use the manufacture
(including import) the PMN substance with an average molecular weight
greater than specified in the Order or with more than 1% of the
molecular weight content below 1,000 Daltons.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (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
15. Add Sec.  14;721.11135 to subpart E to read as follows:

Sec.  721.11135   Imino alkane amine phosphate (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as imino
alkane amine phosphate (P-17-206) 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) and (iii), (a)(3), and (a)(6)(v),
(particulate), (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 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), Sec.  721.63(b) (concentration set at 1.0%)
and Sec.  721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i),
(g)(2)(i) and (v), (g)(3)(i) and (ii), (g)(4)(iii), 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). It is a significant new use to
modify processing or use if it results in inhalation exposure to vapor,
dust, mist, or aerosols to the substance.
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(1),
(b)(1), and (c)(1).
    (v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (k) are applicable to manufacturers, 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
16. Add Sec.  14;721.11136 to subpart E to read as follows:

Sec.  721.11136   Fatty acids, tall-oil, reaction products with 2-[(2-
aminoalkyl)amino]alkanol, compds. with alkylene oxide-glycidyl o-tolyl
ether polymer dihydrogen phosphate alkyl ether (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as fatty
acids, tall-oil, reaction products with 2-[(2-aminoalkyl)amino]alkanol,
compds. with alkylene oxide-glycidyl o-tolyl ether polymer dihydrogen
phosphate alkyl ether (P-17-223) 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), and (a)(6)(v), (particulate), (when
determining which persons are reasonably likely to be exposed as
required for Sec.  721.63(a)(1) and, engineering control measures (e.g.
enclosure or confinement of 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), Sec.  721.63(b) (concentration set at 1.0%) and Sec.
721.63(c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i) and
(ii), (g)(2)(i), (ii), and (v), (g)(3)(i) and (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(f), (k), and (q). It is a significant new
use to modify any processing if such modification would result in
inhalation exposures to the PMN substance by vapor, dust, mist, or
aerosol, at a concentration of greater than 1 percent by weight or
volume. It is a significant new use to use the PMN substance in the
confidential formulation identified in the Order at concentration
greater than 1 percent by weight or volume. It is a significant new use
to manufacture, process, or use the substance for consumer use or for
commercial uses that could introduce the substance into a consumer
setting.
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 15.
    (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
17. Add Sec.  14;721.11137 to subpart E to read as follows:

Sec.  721.11137   Oxirane, 2-alkyl-, polymer with oxirane, mono[N-[3-
(carboxyamino)-4(or 6)-alkylphenyl]carbamate], alkyl ether, ester with