[Federal Register Volume 84, Number 76 (Friday, April 19, 2019)]
[Proposed Rules]
[Pages 16432-16441]
[FR Doc No: 2019-07853]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2018-0772; FRL-9992-42]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances (19-1)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for 11 chemical substances which
are the subject of premanufacture notices (PMNs). This action would
require persons to notify EPA at least 90 days before commencing
manufacture (defined by statute to include import) or processing of any
of these 11 chemical substances for an activity that is designated as a
significant new use by this proposed rule. If this proposed rule is
made final, persons may not commence manufacture or processing for the
significant new use until they have submitted a Significant New Use
Notice, and EPA has conducted a review of the notice, made an
appropriate determination on the notice, and has taken any actions as
are required as a result of that determination.

DATES: Comments must be received on or before May 20, 2019.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0772, 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:<PHONE_NUMBER>; 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 proposed
rule. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
     Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to these proposed SNURs
would need to certify their compliance with the SNUR requirements
should these proposed rules be finalized. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B. In
addition, pursuant to 40 CFR 721.20,

any persons who export or intend to export a chemical substance that is
the subject of this proposed rule on or after May 20, 2019 are subject
to the export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)) and must comply with the export notification requirements in
40 CFR part 707, subpart D.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI to EPA through regulations.gov
or email. Clearly mark the part or all of the information that you
claim to be CBI. For CBI information in a disk or CD-ROM that you mail
to EPA, mark the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. What action is the Agency taking?

    EPA is proposing these SNURs under TSCA section 5(a)(2) for 11
chemical substances which were the subjects of PMNs P-14-482, P-16-422,
P-17-152, P-17-239, P-17-245, P-18-48, P-18-73, P-18-122, P-18-162, P-
18-222, and P-19-10. These proposed SNURs would require persons who
intend to manufacture or process any of these chemical substances for
an activity that is designated as a significant new use to notify EPA
at least 90 days before commencing that activity.
    The record for the proposed SNURs on these chemicals was
established as docket EPA-HQ-OPPT-2018-0772. That record includes
information considered by the Agency in developing these proposed
SNURs.

B. What is the Agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors listed in Unit III. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)(i)
(15 U.S.C. 2604(a)(1)(B)(i)) requires persons to submit a significant
new use notice (SNUN) to EPA at least 90 days before they manufacture
or process the chemical substance for that use. TSCA prohibits such
manufacturing or processing from commencing until EPA has conducted a
review of the SNUN, made an appropriate determination on the SNUN, and
taken such actions as are required in association with that
determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V.,
the general SNUR provisions are found at 40 CFR part 721, subpart A.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. Pursuant to
Sec.  721.1(c), persons subject to these SNURs must comply with the
same SNUN requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A) (15 U.S.C. 2604(a)(1)(A)). In
particular, these requirements include the information submission
requirements of TSCA sections 5(b) and 5(d)(1) (15 U.S.C. 2604(b) and
2604(d)(1)), the exemptions authorized by TSCA sections 5(h)(1),
5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720.
Once EPA receives a SNUN, EPA must either determine that the
significant new use is not likely to present an unreasonable risk of
injury or take such regulatory action as is associated with an
alternative determination before the manufacture or processing for the
significant new use can commence. If EPA determines that the
significant new use is not likely to present an unreasonable risk, EPA
is required under TSCA section 5(g) to make public, and submit for
publication in the Federal Register, a statement of EPA's findings.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a
chemical substance.
     The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
     The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
    To determine what would constitute significant new uses for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances, and
potential human exposures and environmental releases that may be
associated with the conditions of use of the substances, in the context
of the four bulleted TSCA section 5(a)(2) factors listed in this unit.

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements
for 11 chemical substances in 40 CFR part 721, subpart E. In this unit,
EPA provides the following information for each chemical substance:
     PMN number.
     Chemical name (generic name, if the specific name is
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
     Basis for the SNUR.
     Information identified by EPA that would help characterize
the potential health and/or environmental effects of the chemical
substances if a manufacturer or processor is considering submitting a
SNUN for a significant new use designated by the SNUR.
    This information may include testing not required to be conducted
but which would help characterize the potential health and/or
environmental effects of the PMN substance. Any recommendation for
information identified by EPA was made based on EPA's consideration of
available screening-level data, if any, as well as other available
information on appropriate testing for the chemical substance. Further,
any such testing identified by EPA that includes testing on vertebrates
was made after consideration of available toxicity information,
computational toxicology and bioinformatics, and high-throughput
screening methods and their

prediction models. EPA also recognizes that whether testing/further
information is needed will depend on the specific exposure and use
scenario in the SNUN. EPA encourages all SNUN submitters to contact EPA
to discuss any potential future testing. See Unit VII. for more
information.
     CFR citation assigned in the regulatory text section of
these proposed rules.
    The regulatory text section of these proposed rules specifies the
activities designated as significant new uses. Certain new uses,
including production volume limits and other uses designated in the
proposed rules, may be claimed as CBI.
    The chemical substances that are the subject of these proposed
SNURs are undergoing premanufacture review. EPA has initially
determined under TSCA section 5(a)(2), 15 U.S.C. 2604(a)(2), that
certain changes from the intended conditions of use described in the
PMNs could result in changes in the type or form of exposure to the
chemical substances and/or increased exposures to the chemical
substances and/or changes in the reasonably anticipated manner and
methods of manufacturing, processing, distribution in commerce, and
disposal of the chemical substances. Consequently, EPA is proposing to
designate these changes as significant new uses.

PMN Number: P-14-482

    Chemical name: Organic salt (generic).
    CAS number: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substance will be as an industrial chemical.
Based on the physical/chemical properties of the PMN substance and
Structure Analysis Relationships (SAR) analysis of test data on
analogous substances, EPA has identified concerns for developmental
toxicity, neurotoxicity, skin sensitization, and aquatic toxicity at
surface water concentrations exceeding 40 parts per billion (ppb), if
the chemical substance is not used following the limitations noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measures:
    1. No manufacture (including import) of an annual production volume
of the PMN substance greater than the confidential amount stated in the
PMN;
    2. No use of the PMN substance other than the four confidential
uses stated in the PMN; and
    3. No manufacture, processing or use of the PMN substance in any
manner that results in inhalation exposures.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information about the aquatic and human health toxicity and
environmental fate of the PMN substance may be potentially useful to
characterize the health and environmental effects of the PMN substance
if a manufacturer or processor is considering submitting a SNUN for a
significant new use that would be designated by this proposed SNUR. EPA
has determined that the results of fate, pulmonary effects,
developmental toxicity, and aquatic toxicity testing would help
characterize the potential health and environmental effects of the PMN
substance.
    CFR citation: 40 CFR 721.11247.

PMN Number: P-16-422

    Chemical name: 1,2-Cyclohexanedicarboxylic acid, 1-(phenylmethyl)
ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-
methylpropanoate).
    CAS number: 1661012-65-2.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an additive for polymers.
Based on the physical/chemical properties of the PMN substance, data on
the PMN substance, and Structure Analysis Relationships (SAR) analysis
of test data on analogous substances, EPA has identified concerns for
irritation and sensitization, developmental toxicity, and aquatic
toxicity at surface water concentrations exceeding 12 parts per billion
(ppb), if the chemical substance is not used following the limitations
noted. The conditions of use of the PMN substance as described in the
PMN include the following protective measures:
    1. No use of the PMN substance involving an application method that
results in inhalation exposures; and
    2. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance, other than releases from
the confidential polymer additive use described in the PMN, into the
waters of the United States exceeding a surface water concentration of
12 ppb.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information about the aquatic and human health toxicity of the PMN
substance may be potentially useful to characterize the health and
environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of developmental toxicity and aquatic toxicity testing
would help characterize the potential health and environmental effects
of the PMN substance.
    CFR citation: 40 CFR 721.11248.

PMN Number: P-17-152

    Chemical name: Poly-(2-methyl-1-oxo-2-propen-1-yl) ester with
ethanaminium, N,N,N-trialkyl, chloride and methoxypoly(oxy-1,2-
ethanediyl) (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an additive in home care
products. Based on analogy to structurally similar substances, EPA has
identified concerns for aquatic toxicity and lung effects if the
chemical is not used following the limitations noted. The conditions of
use of the PMN substance as described in the PMN include the following
protective measures:
    1. No manufacture, processing or use of the substance in any manner
that results in inhalation exposures;
    2. No manufacture or processing of the PMN substance as a powder or
solid; and
    3. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance exceeding a surface water
concentration of 1 ppb.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information about the toxicity of the PMN substance may be potentially
useful to characterize the health and environmental effects of the PMN
substance if a manufacturer or processor is considering submitting a
SNUN for a significant new use that would be designated by this
proposed SNUR. EPA has determined that the results of aquatic toxicity
and pulmonary effects testing of the PMN substance may be potentially
useful in characterizing the health and environmental effects of the
PMN substance.
    CFR citation: 40 CFR 721.11249.

PMN Number: P-17-239

    Chemical name: Substituted carboxylic acid, polymer with 2,4-
diisocyanato-1-methylbenzene, hexanedioic acid, alpha-hydro-omega-
hydroxypoly[oxy(methyl-1,2-ethanediyl)], 1,1'-methylenebis[4-
isocyanatobenzene], 2,2'-

oxybis[ethanol], 1,1'-oxybis[2-propanol] and 1,2-propanediol,
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adhesive for open non-
descriptive use. Based on data for analogous compounds, EPA has
identified concerns for irritation, sensitization, and oncogenicity if
the chemical is not used following the limitations noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measures:
    1. No use of the PMN substance involving spray application that
results in inhalation exposures;
    2. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance exceeding a surface water
concentration of 33 ppb;
    3. No manufacturing, processing or use of the PMN substance for
consumer use; and
    4. No manufacture with unreacted isocyanate residual greater than
20% by weight.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health and environmental toxicity of the
PMN substance may be potentially useful to characterize the effects of
the PMN substance if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that the results of aquatic
toxicity, mutagenicity, and sensitization testing would help
characterize the potential health and environmental effects of the PMN
substance.
    CFR citations: 40 CFR 721.11250.

PMN Number: P-17-245

    Chemical name: Unsaturated polyfluoro ester (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adhesive for open,
non-dispersive use. 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 potentially persistent,
bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN
substance will persist in the environment for more than six months and
estimates an unknown bioaccumulation factor. EPA has identified
concerns for irritation, respiratory sensitization, and mutagenicity if
the chemical is not used following the limitations noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measures:
    1. No releases of a manufacturing, processing, or use stream
associated with any use of the PMN substance into the waters of the
United States.
    2. Use only for the confidential use stated in the PMN.
    3. Dispose of the PMN substance and any waste streams containing
the PMN substance or its constituent breakdown products only by sending
them via a hazardous waste transporter to a hazardous waste incinerator
permitted under the Resource Conservation and Recovery Act (RCRA) or an
authorized state hazardous waste program.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the effects of the PMN substance if
a manufacturer or processor is considering submitting a SNUN for a
significant new use that would be designated by this proposed SNUR. EPA
has determined that the results of pulmonary effect and sensitization
assay testing would help characterize the potential health effects of
the PMN substance.
    CFR citation: 40 CFR 721.11251.

PMN Number: P-18-48

    Chemical name: Acetic acid, 2-(2-butoxyethoxy)-.
    CAS number: 82941-26-2.
    Basis for action: The PMN states that the use of the substance will
be as an emulsifier for metal working fluid. Based on test data on the
PMN substance and on test data on analogous chemical substances, EPA
has identified concerns for developmental toxicity and corrosion if the
chemical is not used following the limitations noted. The conditions of
use of the PMN substance as described in the PMN include the following
protective measure:
     No manufacture, processing, or use of the PMN substance
for uses other than as emulsifier for metal working fluid.
    The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
    Potentially useful information: EPA has determined that certain
information about the PMN substance may be potentially useful to
characterize the health effects of the PMN substance if a manufacturer
or processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of specific organ toxicity test and, reproductive/
developmental toxicity test would help characterize the potential
health effects of the PMN substance.
    CFR citation: 40 CFR 721.11252.

PMN Number: P-18-73

    Chemical name: Sulfuric acid, ammonium salt (1:?).
    CAS number: 10043-02-4.
    Basis for action: The PMN states that the generic use of the
substance will be as a non-pesticide agricultural use chemical. Based
on test data on the PMN substance and on test data on analogous
chemical substances, EPA has identified concerns for liver, kidney,
lung, and gastrointestinal effects and irritation/corrosion if the
chemical is not used following the limitations noted. The conditions of
use of the PMN substance as described in the PMN include the following
protective measure:
     Use only as a Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) inert ingredient, an anti-scalant, chlorine
stabilizer, or the additional confidential uses stated in the PMN.
    The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
    Potentially useful information: EPA has determined that certain
information about the PMN substance may be potentially useful to
characterize the health effects of the PMN substance if a manufacturer
or processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of specific organ toxicity and skin irritation/corrosion
testing would help characterize the potential health effects of the PMN
substance.
    CFR citation: 40 CFR 721.11253.

PMN Number: P-18-122

    Chemical name: Alkylamide, polymer with alkylamine, formaldehyde,
and polycyanamide, alkyl acid salt (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a paper additive. Based
on analogy to structurally similar substances, EPA has identified
concerns for aquatic toxicity and irritation to skin, eyes and lungs,
and lung toxicity if the chemical is not used following the limitations
noted. The conditions of use

of the PMN substance as described in the PMN include the following
protective measures:
     No release of a processing or use stream associated with
any use of the substance, other than the releases from the intended
conditions of use described in the PMN, into the water of the United
States exceeding a surface water concentration of 1 ppb.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information about the fate and toxicity of the PMN substance may be
potentially useful to characterize the health and environmental effects
of the PMN substance if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that the results of, aquatic
toxicity,, skin irritation, eye irritation and corrosion, and pulmonary
effects testing of the PMN substance may be potentially useful in
characterizing the health and environmental effects of the PMN
substance.
    CFR citation: 40 CFR 721.11254.

PMN Number: P-18-162

    Chemical name: Cashew nutshell liquid, polymer with
diisocyanatoalkane, substituted-polyoxyalkyldiol and polyether polyol
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adhesive component.
Based on analogy to structurally similar substances, EPA has identified
concerns for pulmonary effects if the chemical is not used following
the limitations noted. The conditions of use of the PMN substance as
described in the PMN include the following protective measure:
     No manufacture (including import) the PMN substance in a
form other than as a paste.
    The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
    Potentially useful information: EPA has determined that certain
information about the fate and toxicity of the PMN substance may be
potentially useful to characterize the health and environmental effects
of the PMN substance if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that the results of pulmonary
effects testing of the PMN substance may be potentially useful in
characterizing the health and environmental effects of the PMN
substance.
    CFR citation: 40 CFR 721.11255.

PMN Number: P-18-222

    Chemical name: Silane, alkenylalkoxy-, polymer with alkene and
alkene (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the use of the substance will
be as a reactive polymer for use in adhesive applications. Based on
analogy to structurally similar substances and data on the PMN
substance, EPA has identified concerns for neurotoxicity and pulmonary
effects if the chemical is not used following the limitations noted.
The conditions of use of the PMN substance as described in the PMN
include the following protective measure:
     No manufacture, processing, or use of the PMN substance
other than as a reactive polymer for use in adhesive applications.
    The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
    Potentially useful information: EPA has determined that certain
information about the fate and toxicity of the PMN substance may be
potentially useful to characterize the health and environmental effects
of the PMN substance if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that the results of absorption
and neurotoxicity testing of the PMN substance may be potentially
useful in characterizing the health and environmental effects of the
PMN substance.
    CFR citation: 40 CFR 721.11256.

PMN Number: P-19-10

    Chemical name: Hydrogenated fatty acid dimers, polymers with 1,1'-
methylenebis[4-isocyanatobenzene], polypropylene glycol, polypropylene
glycol ether with trimethylolpropane (3:1), and 1,3-propanediol,
polypropylene glycol monomethacrylate-blocked (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic use of the
substance will be as an adhesive. Based on analogy to structurally
similar isocyanates, EPA has identified concerns for irritation,
sensitization, pulmonary toxicity, mutagenicity and carcinogenicity if
the chemical is not used following the limitations noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measure:
     No use involving an application method that results in
inhalation exposures.
    The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
    Potentially useful information: EPA has determined that certain
information about the toxicity of the PMN substance may be potentially
useful to characterize the health effects of the PMN substance if a
manufacturer or processor is considering submitting a SNUN for a
significant new use that would be designated by this proposed SNUR. EPA
has determined that the results of skin sensitization, genetic
toxicity, pulmonary effects, and eye damage testing of the PMN
substance may be potentially useful in characterizing the health
effects of the PMN substance.
    CFR citation: 40 CFR 721.11257.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances
that are the subject of these proposed SNURs and as further discussed
in Unit IV, EPA identified certain reasonably foreseen changes from the
conditions of use identified in the PMNs and determined that those
changes could result in changes in the type or form of exposure to the
chemical substances and/or increased exposures to the chemical
substances and/or changes in the reasonably anticipated manner and
methods of manufacturing, processing, distribution in commerce, and
disposal of the chemical substances.

B. Objectives

    EPA is proposing SNURs for 11 specific chemical substances which
are undergoing premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses that would be designated in this proposed rule:
     EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
     EPA would be obligated to make a determination under TSCA
section 5(a)(3) regarding the use described in the SNUN, under the
conditions of use. The Agency will either determine under section
5(a)(3)(C) that the significant new use is not likely to present an
unreasonable risk, including an unreasonable risk to a potentially

exposed or susceptible subpopulation identified as relevant by the
Administrator under the conditions of use, or make a determination
under section 5(a)(3) (A) or (B) and take the required regulatory
action associated with the determination, before manufacture or
processing for the significant new use of the chemical substance can
occur.
    Issuance of a proposed SNUR for a chemical substance does not
signify that the chemical substance is listed on the TSCA Inventory.
Guidance on how to determine if a chemical substance is on the TSCA
Inventory is available on the internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. Applicability of the Proposed Rules to Uses Occurring Before the
Effective Date of the Final Rule

    To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
were undergoing premanufacture review at the time of signature of this
proposed rule and were not on the TSCA Inventory. In cases where EPA
has not received a notice of commencement (NOC) and the chemical
substance has not been added to the TSCA Inventory, no person may
commence such activities without first submitting a PMN. Therefore, for
the chemical substances subject to this proposed SNUR, EPA concludes
that the proposed significant new uses are not ongoing.
    EPA designates April 15, 2019 as the cutoff date for determining
whether the new use is ongoing. The objective of EPA's approach is to
ensure that a person cannot defeat a SNUR by initiating a significant
new use before the effective date of the final rule.
    Persons who begin commercial manufacture or processing of the
chemical substances for a significant new use identified on or after
that date would have to cease any such activity upon the effective date
of the final rule. To resume their activities, these persons would have
to first comply with all applicable SNUR notification requirements and
EPA would have to take action under section 5 allowing manufacture or
processing to proceed.

VII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require development of
any particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, order
or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information
to be submitted to EPA at the time of submission of the SNUN.
    In the absence of a rule, order, or consent agreement under TSCA
section 4 covering the chemical substance, persons are required only to
submit information in their possession or control and to describe any
other information known to or reasonably ascertainable by them (see 40
CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. Unit IV. lists potentially
useful information for all SNURs listed here. Descriptions are provided
for informational purposes. The potentially useful information
identified in Unit IV. will be useful to EPA's evaluation in the event
that someone submits a SNUN for the significant new use. Companies who
are considering submitting a SNUN are encouraged, but not required, to
develop the information on the substance, which may assist with EPA's
analysis of the SNUN.
    EPA strongly encourages persons, before performing any testing, to
consult with the Agency pertaining to protocol selection. Furthermore,
pursuant to TSCA section 4(h), which pertains to reduction of testing
in vertebrate animals, EPA encourages consultation with the Agency on
the use of alternative test methods and strategies (also called New
Approach Methodologies, or NAMs), if available, to generate the
recommended test data. EPA encourages dialog with Agency
representatives to help determine how best the submitter can meet both
the data needs and the objective of TSCA section 4(h).
    The potentially useful information described in Unit IV. may not be
the only means of providing information to evaluate the chemical
substance associated with the significant new uses. However, submitting
a SNUN without any test data may increase the likelihood that EPA will
take action under TSCA section 5(e) or 5(f). EPA recommends that
potential SNUN submitters contact EPA early enough so that they will be
able to conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result
from the significant new use of the chemical substances.
     Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available
electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this proposed rule. EPA's complete economic
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2018-0772.

X. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review

    This proposed rule would establish SNURs for 11 new chemical
substances that were the subject of PMNs. The Office of Management and
Budget (OMB) has exempted these types of actions from review under
Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR
3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    According to the PRA, 44 U.S.C. 3501 et seq., an Agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.

    The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
    Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Regulatory Strategies Division, Office of Enterprise Information
Programs (2822T), Environmental Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460-0001. Please remember to include the OMB
control number in any correspondence, but do not submit any completed
forms to this address.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., the
Agency hereby certifies that promulgation of this proposed SNUR would
not have a significant adverse economic impact on a substantial number
of small entities. The requirement to submit a SNUN applies to any
person (including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, it appears that no small or large entities presently
engage in such activities. A SNUR requires that any person who intends
to engage in such activity in the future must first notify EPA by
submitting a SNUN. Although some small entities may decide to pursue a
significant new use in the future, EPA cannot presently determine how
many, if any, there may be. However, EPA's experience to date is that,
in response to the promulgation of SNURs covering over 1,000 chemicals,
the Agency receives only a small number of notices per year. For
example, the number of SNUNs received was seven in Federal fiscal year
(FY) 2013, 13 in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and
11 in FY2018, only a fraction of these were from small businesses. In
addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $16,000 to $2,800.
This lower fee reduces the total reporting and recordkeeping of cost of
submitting a SNUN to about $10,116 for qualifying small firms.
Therefore, the potential economic impacts of complying with this
proposed SNUR are not expected to be significant or adversely impact a
substantial number of small entities. In a SNUR that published in the
Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency
presented its general determination that final SNURs are not expected
to have a significant economic impact on a substantial number of small
entities, which was provided to the Chief Counsel for Advocacy of the
Small Business Administration.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this proposed
rule. As such, EPA has determined that this proposed rule does not
impose any enforceable duty, contain any unfunded mandate, or otherwise
have any effect on small governments subject to the requirements of
UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1531-1538 et seq.).

E. Executive Order 13132: Federalism

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

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly nor uniquely affect the
communities of Indian Tribal governments, nor does it involve or impose
any requirements that affect Indian Tribes. Accordingly, the
requirements of Executive Order 13175 (65 FR 67249, November 9, 2000),
do not apply to this proposed rule.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This proposed rule is not subject to Executive Order 13211 (66 FR
28355, May 22, 2001), because this action is not expected to affect
energy supply, distribution, or use and because this action is not a
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this action does not involve any technical
standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to
this action.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).

List of Subjects in 40 CFR Part 721

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

    Dated: April 15, 2019.
Tala Henry,
Acting Deputy Director, Office of Pollution Prevention and Toxics.

    Therefore, it is proposed that 40 CFR part 721 is amended as
follows:

PART 721--[AMENDED]

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

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

0
2. Add Sec.  721.11247 to subpart E to read as follows:

Sec.  721.11247   Organic salt (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as organic
salt (PMN P-14-482) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as

specified in Sec.  721.80(j). It is a significant new use to
manufacture, process or use the substance in any manner that results in
inhalation exposures. It is a significant new use to exceed the
confidential annual production volume stated in the PMN.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) though (c) and (i), are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (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
3. Add Sec.  721.11248 to subpart E to read as follows:

Sec.  721.11248   1,2-Cyclohexanedicarboxylic acid, 1-(phenylmethyl)
ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-
methylpropanoate).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2-
Cyclohexanedicarboxylic acid, 1-(phenylmethyl) ester, ester with 2,2,4-
trimethyl-1,3-pentanediol mono(2-methylpropanoate) (P-16-422, CAS No.
1661012-65-2) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a
significant new use to use the substance involving an application
method that results in inhalation exposures. It is a significant new
use to release a manufacturing, processing, or use stream associated
with any use of the substance, other than releases from the
confidential polymer additive use described in the PMN, into the waters
of the United States exceeding a surface water concentration of 12 part
per billion (ppb) using the methods described in Sec.  721.91.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
4. Add Sec.  721.11249 to subpart E to read as follows:

Sec.  721.11249   Poly-(2-methyl-1-oxo-2-propen-1-yl) ester with
ethanaminium, N,N,N-trialkyl, chloride and methoxypoly(oxy-1,2-
ethanediyl) (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as poly-
(2-methyl-1-oxo-2-propen-1-yl) ester with ethanaminium, N,N,N-trialkyl,
chloride and methoxypoly(oxy-1,2-ethanediyl) (P-17-152) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  721.90
(a)(4), (b)(4), and (c)(4) where N = 1.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers,
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
5. Add Sec.  721.11250 to subpart E to read as follows:

Sec.  721.11250   Substituted carboxylic acid, polymer with 2,4-
diisocyanato-1-methylbenzene, hexanedioic acid, alpha-hydro-omega-
hydroxypoly[oxy(methyl-1,2-ethanediyl)], 1,1'-methylenebis[4-
isocyanatobenzene], 2,2'-oxybis[ethanol], 1,1'-oxybis[2-propanol] and
1,2-propanediol, (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
substituted carboxylic acid, polymer with 2,4-diisocyanato-1-
methylbenzene, hexanedioic acid, alpha-hydro-omega-
hydroxypoly[oxy(methyl-1,2-ethanediyl)], 1,1'-methylenebis[4-
isocyanatobenzene], 2,2'-oxybis[ethanol], 1,1'-oxybis[2-propanol] and
1,2-propanediol), (P-17-239) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (o). It is a significant new use to use
the substance involving spray application that results in inhalation
exposures. It is a significant new use to manufacture (includes
importing) the substance to contain more than 20% residual isocyanate
by weight.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 33.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
6. Add Sec.  721.11251 to subpart E to read as follows:

Sec.  721.11251   Unsaturated polyfluoro ester, (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically as unsaturated
polyfluoro ester, (P-17-245) 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) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (ii) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (j).
    (iii) Disposal. It is a significant new use to dispose of the
substance and any waste streams containing the substance or its
constituent breakdown products other than by sending them via a
hazardous waste transporter to a hazardous waste incinerator permitted
under the Resource Conservation and Recovery Act (RCRA) or an
authorized state hazardous waste program.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), (j) and (k) are applicable to
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The

provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
0
7. Add Sec.  721.11252 to subpart E to read as follows:

Sec.  721.11252   Acetic acid, 2-(2-butoxyethoxy)-.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance with non-confidential name as
acetic acid, 2-(2-butoxyethoxy)- (P-18-48, CAS No. 82941-26-2) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a
significant new use to use the substance other than as emulsifier for
metal working fluid.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
8. Add Sec.  721.11253 to subpart E to read as follows:

Sec.  721.11253   Sulfuric acid, ammonium salt (1:?).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as organic salt (PMN
P-18-73, CAS No. 10043-02-4) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (j). It is a significant new use to use
the substance other than a Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) inert ingredient, an anti-scalant, a chlorine
stablizer, or the additional confidential uses described in the PMN.
    (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) thru (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)(iii)
of this section.
0
9. Add Sec.  721.11254 to subpart E to read as follows:

Sec.  721.11254   Alkylamide, polymer with alkylamine, formaldehyde,
and polycyanamide, alkyl acid salt (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
alkylamide, polymer with alkylamine, formaldehyde, and polycyanamide,
alkyl acid salt (P-18-122) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a
significant new use to release a manufacturing, processing, or use
stream associated with any use of the substances, other than the
confidential chemical intermediate use described in the premanufacture
notices, into the waters of the United States exceeding a surface water
concentration of 1 part per billion (ppb) using the methods described
in Sec.  721.91.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
10. Add Sec.  721.11255 to subpart E to read as follows:

Sec.  721.11255   Cashew nutshell liquid, polymer with
diisocyanatoalkane, substituted-polyoxyalkyldiol and polyether polyol
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as Cashew
nutshell liquid, polymer with diisocyanatoalkane, substituted-
polyoxyalkyldiol and polyether polyol (P-18-162) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a
significant new use to manufacture (including import) in a form other
that as a paste.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
11. Add Sec.  721.11256 to subpart E to read as follows:

Sec.  721.11256   Silane, alkenylalkoxy-, polymer with alkene and
alkene (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as silane,
alkenylalkoxy-, polymer with alkene and alkene (P-18-222) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance for
uses other than as a reactive polymer for use in adhesive applications.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
12. Add Sec.  721.11257 to subpart E to read as follows:

Sec.  721.11257   Hydrogenated fatty acid dimers, polymers with 1,1'-
methylenebis[4-isocyanatobenzene], polypropylene glycol, polypropylene
glycol ether with trimethylolpropane (3:1), and 1,3-propanediol,
polypropylene glycol monomethacrylate-blocked.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
hydrogenated fatty acid

dimers, polymers with 1,1'-methylenebis[4-isocyanatobenzene],
polypropylene glycol, polypropylene glycol ether with
trimethylolpropane (3:1), and 1,3-propanediol, polypropylene glycol
monomethacrylate-blocked (P-19-10) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a
significant new use to use the substance involving an application
method that results in inhalation exposures.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2019-07853 Filed 4-18-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: January 5, 2010 (Volume 75, Number 2)]
[Rules and Regulations]
[Page 221-224]
[DOCID:fr05ja10-2]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-1225; Directorate Identifier 2009-NM-257-AD;
Amendment 39-16159; AD 2010-01-03]
RIN 2120-AA64

Airworthiness Directives; Fire Fighting Enterprises Limited
Portable Halon 1211 Fire Extinguishers as Installed on Various
Transport Airplanes, Small Airplanes, and Rotorcraft

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    The Civil Aviation Authority of the United Kingdom (UK) has
informed EASA [European Aviation Safety Agency] that significant
quantities of Halon 1211 gas, determined to be outside the required
specification, have been supplied to the aviation industry for use
in fire extinguishing equipment. * * *
* * * * *
    * * * This Halon 1211 has subsequently been used to fill certain
FFE [Fire Fighting Enterprises] portable cabin and toilet
compartment fire extinguishers that are now likely to be installed
in or carried on board aircraft.
    The contaminated nature of this gas, when used against a fire,
may provide reduced fire suppression, endangering the safety of the
aircraft and its occupants. In addition, extinguisher activation may
lead to release of toxic fumes, possibly causing injury to aircraft
occupants.
* * * * *
This AD requires actions that are intended to address the unsafe
condition described in the MCAI.

DATES: This AD becomes effective January 20, 2010.
    We must receive comments on this AD by February 19, 2010.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-2125; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued
Emergency Airworthiness Directive 2009-0251-E, dated November 25, 2009,
and Airworthiness Directive 2009-0262, dated December 15, 2009
(referred to after this as ``the MCAI''), to correct an unsafe
condition for the specified products. EASA AD 2009-0251-E states:

    The Civil Aviation Authority of the United Kingdom (UK) has
informed EASA that significant quantities of Halon 1211 gas,
determined to be outside the required specification, have been
supplied to the aviation industry for use in fire extinguishing
equipment. Halon 1211 (BCF) is used in handheld fire extinguishers,
usually fitted or stowed in aircraft cabins.
    EASA published Safety Information Bulletin (SIB) 2009-39 on 23
October 2009 to make the aviation community aware of this safety
concern.
    The results of the ongoing investigation now show that LyonTech
Engineering Ltd, a UK-based company, has supplied a quantity of
heavily contaminated Halon 1211 (BCF) to Fire Fighting Enterprises
(FFE). This Halon 1211 has subsequently been used to fill certain
FFE portable fire extinguishers that are now likely to be installed
in or carried on board aircraft.
    The contaminated nature of this gas, when used against a fire,
may lead to release of toxic fumes, possibly causing injury to
aircraft occupants.
    For the reason described above, this EASA AD requires the
identification and removal from service of all affected fire
extinguishers and replacement with serviceable units.

EASA AD 2009-0262 adds the following:

    * * * On 25 November 2009, EASA Emergency AD 2009-0251E was
published to address an earlier batch of extinguishers with
contaminated Halon 1211.
    The results of the ongoing investigation have now established
that LyonTech Engineering Ltd, a UK-based company, has supplied
further consignments of Halon 1211 (BCF) to Fire Fighting
Enterprises (FFE) that do not meet the required specification. This
Halon 1211 has subsequently been used to fill certain FFE portable
cabin and toilet compartment fire extinguishers that are now likely
to be installed in or carried on board aircraft.
    The contaminated nature of this gas, when used against a fire,
may provide reduced fire suppression, endangering the safety of the
aircraft and its occupants. In addition, extinguisher activation may
lead to release of toxic fumes, possibly causing injury to aircraft
occupants.
* * * * *
You may obtain further information by examining the MCAI in the AD
docket.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are issuing this AD because we
evaluated all pertinent information and determined the unsafe condition
exists and is likely to exist or

develop on other products of the same type design.

Differences Between the AD and the MCAI

    We have reviewed the MCAI and, in general, agree with their
substance. But we might have found it necessary to use different words
from those in the MCAI to ensure the AD is clear for U.S. operators and
is enforceable. In making these changes, we do not intend to differ
substantively from the information provided in the MCAI and related
service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a Note within the AD.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because
contaminated Halon 1211 gas has been used to fill certain portable
cabin and toilet compartment fire extinguishers that are now likely to
be installed in or carried on board aircraft. The contaminated nature
of this gas, when used against a fire, may provide reduced fire
suppression, endangering the safety of the aircraft and its occupants.
In addition, extinguisher activation may lead to release of toxic
fumes, possibly causing injury to aircraft occupants. Therefore, we
determined that notice and opportunity for public comment before
issuing this AD are impracticable and that good cause exists for making
this amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2009-1225; Directorate
Identifier 2009-NM-257-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the 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.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2010-01-03 Fire Fighting Enterprises Limited: Amendment 39-16159.
Docket No. FAA-2009-1225; Directorate Identifier 2009-NM-257-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective January
20, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to portable Halon 1211 (BCF) fire
extinguishers manufactured by Fire Fighting Enterprises Limited.
These fire extinguishers may be installed on (or carried or stowed
on board) various transport airplanes, small airplanes, and
rotorcraft, certificated in any category, identified in but not
limited to the airplanes and rotorcraft of the manufacturers
included in Table 1 of this AD, all type-certificated models.

               Table 1--Affected Airplanes and Rotorcraft
------------------------------------------------------------------------
               Manufacturer                       Product subtype
------------------------------------------------------------------------
328 Support Services GmbH (Type            Transport Airplane.
 Certificate previously held by AvCraft
 Aerospace GmbH; Fairchild Dornier GmbH;
 Dornier Luftfahrt GmbH).
Aermacchi S.p.A..........................  Small Airplane.
Agusta S.p.A.............................  Rotorcraft.
AgustaWestland...........................  Rotorcraft.
Airbus (Type Certificate previously held   Transport Airplane.
 by Airbus Industrie).
Aircraft Industries a.s. (Type             Small Airplane.
 Certificate previously held by
 LETECK[Eacute] Z[Aacute]VODY a.s.; LET
 Aeronautical Works).
Alenia Aeronautica.......................  Transport Airplane.

B-N Group Ltd (Type Certificate            Small Airplane.
 previously held by Pilatus Britten-
 Norman Limited; Britten-Norman
 (Bembridge) Limited).
BAE Systems (Operations) Limited (Type     Transport Airplane.
 Certificate previously held by British
 Aerospace Regional Aircraft; British
 Aerospace (Commercial Aircraft) Limited;
 Jetstream Aircraft Limited; British
 Aerospace, PLC; Avro International
 Aerospace Division; British Aerospace).
The Boeing Company.......................  Transport Airplane.
Empresa Brasileira de Aeronautica S.A.     Transport Airplane.
 (EMBRAER).
Eurocopter Deutschland GMBH (ECD) (Type    Rotorcraft.
 Certificate previously held by
 Messerschmitt-Bolkow-Blohm-Gmbh).
Eurocopter France........................  Rotorcraft.
Fokker Services B.V......................  Transport Airplane.
Hawker Beechcraft (Type Certificate        Small Airplane.
 previously held by Raytheon Aircraft
 Company; Beech Aircraft Corporation).
Pilatus Aircraft Ltd.....................  Small Airplane.
Saab AB, Saab Aerosystems (Type            Transport Airplane.
 Certificate previously held by SAAB
 AIRCRAFT AB; SAAB[dash]Fairchild).
Short Brothers PLC (Type Certificate       Transport Airplane.
 previously held by Short Brothers, Ltd.).
Triton America LLC (Type Certificate       Small Airplane.
 previously held by AAI Acquisition, Inc;
 Adam Aircraft).
Vulcanair S.p.A. (Type Certificate         Small Airplane.
 previously held by Partenavia
 Costruzioni Aeronautiche S.p.A).
------------------------------------------------------------------------

Subject

    (d) Air Transport Association (ATA) of America Code 26: Fire
Protection.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
consists of two European Aviation Safety Agency (EASA) ADs: 2009-
0251-E, dated November 25, 2009, and 2009-0262, dated December 15,
2009. EASA AD 2009-0251-E states:
    The Civil Aviation Authority of the United Kingdom (UK) has
informed EASA that significant quantities of Halon 1211 gas,
determined to be outside the required specification, have been
supplied to the aviation industry for use in fire extinguishing
equipment. Halon 1211 (BCF) is used in handheld fire extinguishers,
usually fitted or stowed in aircraft cabins.
    EASA published Safety Information Bulletin (SIB) 2009-39 on 23
October 2009 to make the aviation community aware of this safety
concern.
    The results of the ongoing investigation now show that LyonTech
Engineering Ltd, a UK-based company, has supplied a quantity of
heavily contaminated Halon 1211 (BCF) to Fire Fighting Enterprises
(FFE). This Halon 1211 has subsequently been used to fill certain
FFE portable fire extinguishers that are now likely to be installed
in or carried on board aircraft.
    The contaminated nature of this gas, when used against a fire,
may lead to release of toxic fumes, possibly causing injury to
aircraft occupants.
    For the reason described above, this EASA AD requires the
identification and removal from service of all affected fire
extinguishers and replacement with serviceable units.

EASA AD 2009-0262 adds the following:
* * * * *
    * * * On 25 November 2009, EASA Emergency AD 2009-0251E was
published to address an earlier batch of extinguishers with
contaminated Halon 1211.
    The results of the ongoing investigation have now established
that LyonTech Engineering Ltd, a UK-based company, has supplied
further consignments of Halon 1211 (BCF) to Fire Fighting
Enterprises (FFE) that do not meet the required specification. This
Halon 1211 has subsequently been used to fill certain FFE portable
cabin and toilet compartment fire extinguishers that are now likely
to be installed in or carried on board aircraft.
    The contaminated nature of this gas, when used against a fire,
may provide reduced fire suppression, endangering the safety of the
aircraft and its occupants. In addition, extinguisher activation may
lead to release of toxic fumes, possibly causing injury to aircraft
occupants.
* * * * *

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) Do the following actions.
    (1) Within 90 days after the effective date of this AD, replace
portable Halon 1211 (BCF) fire extinguishers manufactured by Fire
Fighting Enterprises Limited with serviceable fire extinguishers;
except as provided by paragraph (g)(2) of this AD.
    (2) Fire extinguishers identified in paragraphs (g)(2)(i) and
(g)(2)(ii) of this AD are not required to be replaced.
    (i) Fire extinguishers conclusively determined to have been most
recently filled with Halon 1211 supplied by a company other than
LyonTech Engineering Limited.
    (ii) Fire extinguishers that have been most recently filled by
LyonTech Engineering Limited and that are conclusively determined by
Fire Fighting Enterprises Limited to be filled with Halon 1211 that
meets their design specification for Halon purity.
    (3) As of the effective date of this AD, do not install any
portable fire extinguisher manufactured by Fire Fighting Enterprises
Limited unless it has been conclusively determined that the last
time it was filled, it was filled with Halon 1211 supplied by a
company other than LyonTech Engineering Limited; or it has been
conclusively determined by Fire Fighting Enterprises Limited that
the last time it was filled, it was filled with Halon 1211 that
meets their design specification for Halon purity.

FAA AD Differences

    Note:  This AD differs from the MCAI and/or service information
as follows:
    (1) EASA ADs 2009-0251-E and 2009-0262 specify to inspect for
certain fire extinguishers manufactured by Fire Fighting Enterprises
Limited and replace if necessary. This AD requires replacing all
fire extinguishers manufactured by Fire Fighting Enterprises Limited
except as provided in paragraph (g)(2) of this AD.
    (2) EASA AD 2009-0251-E specifies a time of 2 days to do the
actions and EASA AD 2009-0262 specifies a time of 30 days to do the
actions. This AD requires that the actions be done within 90 days.
We have determined that a 90-day compliance time will ensure an
acceptable level of safety.

Other FAA AD Provisions

    (h) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The manager of
the office having certificate responsibility for the affected
product has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
will coordinate requests for approval of AMOCs with the manager of
the appropriate office for the affected product. Send information to
ATTN: Dan Rodina, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated

agent). You are required to assure the product is airworthy before
it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (i) Refer to MCAI EASA Emergency Airworthiness Directive 2009-
0251-E, dated November 25, 2009; and EASA Airworthiness Directive
2009-0262, dated December 15, 2009; for related information.

Material Incorporated by Reference

    (j) None.

    Issued in Washington, DC, on December 28, 2009.
Kalene C. Yanamura,
Acting Director, Aircraft Certification Service.
[FR Doc. E9-31134 Filed 1-4-10; 8:45 am]

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[Federal Register Volume 75, Number 35 (Tuesday, February 23, 2010)]
[Notices]
[Pages 8178-8179]
[FR Doc No: 2010-3452]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Application of Rugby Aviation LLC D/B/A Northwest Sky Ferry for
Commuter Air Carrier Authority

AGENCY: Department of Transportation.

ACTION: Notice of Order to Show Cause (Order 2010-2-7) Docket OST-2009-
0188.

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

SUMMARY: The Department of Transportation is directing all interested
persons to show cause why it should not issue an order finding Rugby

Aviation, LLC d/b/a Northwest Sky Ferry fit, willing, and able, and
awarding it commuter air carrier authority to conduct scheduled
commuter service.

DATES: Persons wishing to file objections should do so no later than
February 26, 2010.

ADDRESSES: Objections and answers to objections should be filed in
Docket DOT-OST-2009-0188 and addressed to Docket Operations, (M-30,
Room W12-140), U.S. Department of Transportation, 1200 New Jersey
Avenue, SE., Washington, DC 20590, and should be served upon the
parties listed in Attachment A to the order.

FOR FURTHER INFORMATION CONTACT: Catherine O'Toole, Air Carrier Fitness
Division (X-56, Room W86-489), U.S. Department of Transportation, 1200
New Jersey Avenue, SE., Washington, DC 20590,<PHONE_NUMBER>.

    Dated: February 16, 2010.
Susan L. Kurland,
Assistant Secretary For Aviation and International Affairs.
[FR Doc. 2010-3452 Filed 2-22-10; 8:45 am]
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