[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)]
[Notices]
[Pages 26052-26057]
[FR Doc No: 2018-12059]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0716; FRL-9978-06]

Certain New Chemical Substances; Receipt and Status Information
for February 2018

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA),
as amended by the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, to make information publicly available and to publish
information in the Federal Register pertaining to submissions under
TSCA Section 5, including notice of receipt of a Premanufacture notice
(PMN), Significant New Use Notice (SNUN) or Microbial Commercial
Activity Notice (MCAN), including an amended notice or test
information; an exemption application under 40 CFR part 725 (Biotech
exemption); an application for a test marketing exemption (TME), both
pending and/or concluded; a notice of commencement (NOC) of manufacture
(including import) for new chemical substances; and a periodic status
report on new chemical substances that are currently under EPA review
or have recently concluded review. This document covers the period from
February 1, 2018 to February 28, 2018.

DATES: Comments identified by the specific case number provided in this
document must be received on or before July 5, 2018.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2017-0716, and the specific case number for the
chemical substance related to your comment, 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: Jim
Rahai, Information Management Division (MC 7407M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-8593; 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. Executive Summary

A. What action is the Agency taking?

    This document provides the receipt and status reports for the
period from February 1, 2018 to February 28, 2018. The Agency is
providing notice of receipt of PMNs, SNUNs and MCANs (including amended
notices and test information); an exemption application under 40 CFR
part 725 (Biotech exemption); TMEs, both pending and/or concluded; NOCs
to manufacture a new chemical substance; and a periodic status report
on new chemical substances that are currently under EPA review or have
recently concluded review.
    EPA is also providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a
weekly basis.

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

    Under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et
seq., a chemical substance may be either an ``existing'' chemical
substance or a ``new'' chemical substance. Any chemical substance that
is not on EPA's TSCA Inventory of Chemical Substances (TSCA Inventory)
is classified as a ``new chemical substance,'' while a chemical
substance that is listed on the TSCA Inventory is classified as an
``existing chemical substance.'' (See TSCA section 3(11).) For more
information about the TSCA Inventory go to: https://www.epa.gov/tsca-inventory.
    Any person who intends to manufacture (including import) a new
chemical substance for a non-exempt commercial purpose, or to
manufacture or process a chemical substance in a non-exempt manner for
a use that EPA has determined is a significant new use, is required by
TSCA section 5 to provide EPA with a PMN, MCAN or SNUN, as appropriate,
before initiating the activity. EPA will review the notice, make a risk
determination on the chemical substance or significant new use, and
take appropriate action as described in TSCA section 5(a)(3).
    TSCA section 5(h)(1) authorizes EPA to allow persons, upon
application and under appropriate restrictions, to manufacture or
process a new chemical substance, or a chemical substance subject to a
significant new use rule (SNUR) issued under TSCA section 5(a)(2), for
``test marketing'' purposes, upon a showing that the manufacture,
processing, distribution in commerce, use, and disposal of the chemical
will not present an unreasonable risk of injury to health or the
environment. This is referred to as a test marketing exemption, or TME.
For more information about the requirements applicable to a new
chemical go to: http://www.epa.gov/oppt/newchems.
    Under TSCA sections 5 and 8 and EPA regulations, EPA is required to
publish in the Federal Register certain information, including notice
of receipt of a PMN/SNUN/MCAN (including amended notices and test
information); an exemption application under 40 CFR part 725 (biotech
exemption); an application for a TME, both pending and concluded; NOCs
to manufacture a new chemical substance; and a periodic status report
on the new chemical substances that are currently under EPA review or
have recently concluded review.

C. Does this action apply to me?

    This action provides information that is directed to the public in
general.

D. Does this action have any incremental economic impacts or paperwork
burdens?

    No.

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

    1. Submitting confidential business information (CBI). Do not
submit this information to EPA through regulations.gov or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that

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

II. Status Reports

    In the past, EPA has published individual notices reflecting the
status of TSCA section 5 filings received, pending or concluded. In
1995, the Agency modified its approach and streamlined the information
published in the Federal Register after providing notice of such
changes to the public and an opportunity to comment (See the Federal
Register of May 12, 1995, (60 FR 25798) (FRL-4942-7). Since the passage
of the Lautenberg amendments to TSCA in 2016, public interest in
information on the status of section 5 cases under EPA review and, in
particular, the final determination of such cases, has increased. In an
effort to be responsive to the regulated community, the users of this
information, and the general public, to comply with the requirements of
TSCA, to conserve EPA resources and to streamline the process and make
it more timely, EPA is providing information on its website about cases
reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN
and exemption notices received, the date of receipt, the final EPA
determination on the notice, and the effective date of EPA's
determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a
weekly basis.

III. Receipt Reports

    For the PMN/SNUN/MCANs received by EPA during this period, Table I
provides the following information (to the extent that such information
is not subject to a CBI claim) on the notices received by EPA during
this period: The EPA case number assigned to the notice that indicates
whether the submission is an initial submission, or an amendment, a
notation of which version was received, the date the notice was
received by EPA, the submitting manufacturer (i.e., domestic producer
or importer), the potential uses identified by the manufacturer in the
notice, and the chemical substance identity.
    As used in each of the tables in this unit, (S) indicates that the
information in the table is the specific information provided by the
submitter, and (G) indicates that this information in the table is
generic information because the specific information provided by the
submitter was claimed as CBI. Submissions which are initial submissions
will not have a letter following the case number. Submissions which are
amendments to previous submissions will have a case number followed by
the letter ``A'' (e.g. P-18-1234A). The version column designates
submissions in sequence as ``1'', ``2'', ``3'', etc. Note that in some
cases, an initial submission is not numbered as version 1; this is
because earlier version(s) were rejected as incomplete or invalid
submissions. Note also that future versions of the following tables may
adjust slightly as the Agency works to automate population of the data
in the tables.

                           Table I--PMN/SNUN/MCANs Received From 2/1/2018 to 2/28/2018
----------------------------------------------------------------------------------------------------------------
                                             Received                                               Chemical
            Case No.              Version      date       Manufacturer             Use             substance
----------------------------------------------------------------------------------------------------------------
P-16-0397A.....................          6  2/23/2018  CBI...............  (G) Contained use   (G) Zirconium
                                                                            in a closed         salt.
                                                                            process.
P-16-0544A.....................          3  2/13/2018  Guardian            (S) Additive to     (S) Flue dust,
                                                        Industries Corp.    influence melting   glass-manufg.
                                                                            temperature of      desulfurization,
                                                                            raw materials and   calcium
                                                                            physical            hydroxide-
                                                                            characteristics     treated.
                                                                            of the final
                                                                            product during
                                                                            the manufacture
                                                                            of flat glass.
P-16-0581A.....................          2  2/12/2018  CBI...............  (S) Polymer         (G) Alpha 1,3-
                                                                            Additive; Paper     polysaccharide.
                                                                            Coating
                                                                            Component;
                                                                            Composite
                                                                            Component; Fiber
                                                                            Additive.
P-17-0253A.....................          2  2/16/2018  CBI...............  (G) The polymer     (G) Oxirane, 2-
                                                                            will be sold to     methyl-, polymer
                                                                            the customer in     with oxirane,
                                                                            liquid form.        methyl 2-
                                                                            Customers will      (substituted
                                                                            then blend the      carbomonocycle
                                                                            polymer to          isoquinolin-
                                                                            achieve their       2(3H)-yl) propyl
                                                                            desired             ether.
                                                                            formulation
                                                                            properties.
P-17-0400A.....................          4  2/16/2018  CBI...............  (G) Rubber          (G) Terpolymer of
                                                                            products.           Vinylidene
                                                                                fluoride,
                                                                                Tetrafluoroehyle
                                                                                ne and 2,3,3,3-
                                                                                Tetrafluoroprope
                                                                                ne.
P-18-0015A.....................          2  2/12/2018  CBI...............  (G) Industrial      (G) Dialkylamine,
                                                                            inks and coatings.  reaction
                                                                                products with
                                                                                polyalkylene
                                                                                glycol ether
                                                                                with
                                                                                alkylolalkane
                                                                                acrylate.
P-18-0049A.....................          2   2/1/2018  Solvay Fluorides    (G) Coating         (G) Mixed metal
                                                        LLC.                component/          halide.
                                                                            processing aid.
P-18-0062A.....................          3  2/20/2018  IMKorus, Inc......  (G) Open, non-      (S) Oxirane, 2,2'-
                                                                            dispersive use in   [cyclohexylidene
                                                                            coatings            bis(4,1-
                                                                            specifically for    phenyleneoxymeth
                                                                            the electronics     ylene)]bis-.
                                                                            fields.
P-18-0084......................          2   2/6/2018  ShayoNano USA,      (S) Additive for    (S) Silicon zinc
                                                        Inc..               paints and          oxide.
                                                                            coatings.
P-18-0092A.....................          3   2/6/2018  Shell Chemical LP-- (G) The TBPMI       (S) Phosphonium,
                                                        Martinez Catalyst   chemical is used    tributylmethyl-,
                                                        Plant.              as a catalyst,      iodide (1:1).
                                                                            the catalyst is
                                                                            imported and used
                                                                            in the
                                                                            manufacture of
                                                                            monoethlyene
                                                                            glycol (MEG).

P-18-0102A.....................          2   2/5/2018  Allnex USA, Inc...  (G) UV Curable      (G) Alkanoic
                                                                            Coating Resin.      acid, ester with
                                                                                [oxybis(alkylene
                                                                                )]bis[alkyl-
                                                                                substituted
                                                                                alkanediol],
                                                                                polymer with
                                                                                alkylcarbonate,
                                                                                alkanediols,
                                                                                substituted
                                                                                alkanoic acid
                                                                                and isocyanate
                                                                                and alkyl
                                                                                substituted
                                                                                carbomonocycle,
                                                                                sodium salt.
P-18-0103......................          2   2/5/2018  CBI...............  (S) Intermediate    (G) Alkylnitrile
                                                                            for Amine           imidazole.
                                                                            Manufacture.
P-18-0105......................          1   2/1/2018  Reagens USA, Inc..  (S) This product    (S) Phosphorous
                                                                            is used in rigid    acid,
                                                                            and flexible PVC    triisotridecyl
                                                                            processing as a     ester.
                                                                            booster of PVC
                                                                            stabilizers. It
                                                                            improves long
                                                                            term stability,
                                                                            initial color and
                                                                            the weathering
                                                                            performance of
                                                                            end products.
P-18-0106......................          2   2/8/2018  CBI...............  (S) Process aid...  (G)
                                                                                Perfluoro[(alken
                                                                                yl)oxy] alkane-,
                                                                                manuf. of, by-
                                                                                products from,
                                                                                distn. residues.
P-18-0107......................          1   2/6/2018  Lanxess             (S) Hydrolysis      (G) Alcohol
                                                        Corporation.        stabilizer.         capped
                                                                                polycarbodiimide
                                                                                from
                                                                                diethyldiisocyan
                                                                                atobenzene.
P-18-0108......................          1  2/12/2018  CBI...............  (G) Ionic salt of   (G) Aromatic
                                                                            a polyamic acid     anhydride
                                                                            for coatings,       polymer with
                                                                            open, non-          bisalkylbiphenyl
                                                                            dispersive use.     bisamine
                                                                                compound with
                                                                                alkylaminoalkyl
                                                                                acrylate ester.
P-18-0109......................          1  2/16/2018  CBI...............  (G) Additive,       (G) 2-Alkenoic
                                                                            open, non-          acid, 2-alkyl-,
                                                                            dispersive use.     alkyl ester,
                                                                                polymer with 2-
                                                                                (dialkylamino)al
                                                                                kyl 2-alkyl-2-
                                                                                alkenoate, alkyl
                                                                                2-alkyl-2-
                                                                                alkenoate and -
                                                                                (2-alkyl-1-oxo-2-
                                                                                alken 1-yl)-
                                                                                [iquest]-
                                                                                alkoxypoly(oxy-
                                                                                1,2-alkanediyl),
                                                                                [(1-alkoxy-2-
                                                                                alkyl-1-alken-1-
                                                                                yl)oxy]trialkyls
                                                                                ilane-initiated.
P-18-0110......................          1  2/16/2018  CBI...............  (G) Open            (G) Formaldehyde,
                                                                            dispersive use.     polymer with
                                                                            Component in        arylylpolyamine,
                                                                            liquid paint        2-(chloromethyl)
                                                                            coating.            oxirane and
                                                                                phenol.
P-18-0111......................          1  2/16/2018  CBI...............  (G) Component in    (G) Formaldehyde,
                                                                            liquid paint        polymer with
                                                                            coating.            arylylpolyamine,
                                                                                2-(chloromethyl)
                                                                                oxirane and
                                                                                phenol.
P-18-0112......................          1  2/18/2018  CBI...............  (G) Corrosion       (S) 3,5,5-
                                                                            inhibitor.          trimethylhexanoi
                                                                                c acid, compound
                                                                                with 2-
                                                                                aminoethanol
                                                                                (1:1).
P-18-0113......................          1  2/18/2018  CBI...............  (G) Corrosion       (S) 3,5,5-
                                                                            inhibitor.          trimethylhexanoi
                                                                                c acid, compound
                                                                                with 2,2',2''-
                                                                                nitrilotris(etha
                                                                                nol) (1:1).
P-18-0112A.....................          2  2/20/2018  CBI...............  (G) Corrosion       (S) 3,5,5-
                                                                            inhibitor.          trimethylhexanoi
                                                                                c acid, compound
                                                                                with 2-
                                                                                aminoethanol
                                                                                (1:1).
P-18-0113A.....................          2  2/20/2018  CBI...............  (G) Corrosion       (S) 3,5,5-
                                                                            inhibitor.          trimethylhexanoi
                                                                                c acid, compound
                                                                                with 2,2',2''-
                                                                                nitrilotris(etha
                                                                                nol) (1:1).
P-18-0114......................          1  2/19/2018  Miwon North         (S) Resins for      (G) Propanoic
                                                        America, Inc.       industrial          acid, hydroxy-
                                                                            coating.            (hydroxyalkyl)-
                                                                                alkyl-, polymer
                                                                                with 1,6-
                                                                                diisocyanatoalka
                                                                                ne and
                                                                                poly[oxy(alkyl-
                                                                                alkanediyl)]
                                                                                ether with alkyl
                                                                                (hydroxyalkyl)-
                                                                                alkanediol, 2-
                                                                                propenoate
                                                                                (ester), lithium
                                                                                salt, glycerol
                                                                                monoacrylate 1-
                                                                                neodecanoate-
                                                                                and alkylene
                                                                                glycol
                                                                                monoacrylate-
                                                                                blocked.
P-18-0116......................          1  2/27/2018  CBI...............  (G) Intermediate    (G) Fatty acid
                                                                            for industrial      oil reaction
                                                                            chemical.           product with
                                                                                fatty acid oil.
P-18-0118......................          1  2/26/2018  H.B. Fuller         (G) Industrial      (G) Oxirane, 2-
                                                        Company.            adhesive.           methyl-, polymer
                                                                                with methoxirane
                                                                                homopolymer,
                                                                                1,1'-
                                                                                methylenebis[4-
                                                                                isocyanatobenzen
                                                                                e], and glycerol-
                                                                                propylene oxide
                                                                                polymer.
P-18-0119......................          1  2/26/2018  H. B. Fuller        (G) Industrial      (G) Oxirane, 2-
                                                        Company.            adhesive.           methyl-, polymer
                                                                                with methoxirane
                                                                                homopolymer,
                                                                                1,1'-
                                                                                methylenebis[iso
                                                                                cyanatobenzene],
                                                                                and glycerol-
                                                                                propylene oxide
                                                                                polymer.
P-18-0120......................          1  2/26/2018  Designer            (G) Adhesive        (S) Amines, C36-
                                                        Molecules, Inc.     component.          Alkylenedi,
                                                                                maleated.
P-18-0121......................          1  2/27/2018  Kyodo Yushi USA,    (G) Additive for    (S) Benzene, 1,1'-
                                                        Inc.                Lubricating         oxybis-,
                                                                            Grease.             branched eicosyl
                                                                                derivs.
SN-17-0005A....................          3   2/7/2018  Domino Amjet, Inc.  (S) Raw material    (S) 2-Propenoic
                                                                            for use as          acid, 1,1'-(3-
                                                                            component in UV     methyl-1,5-
                                                                            curable coatings    pentanediyl)
                                                                            and printing        ester.
                                                                            inks..

SN-18-0002.....................          1  2/16/2018  CBI...............  (G) Flame           (G)
                                                                            retardant for       Phosphoramidic
                                                                            textile.            acid,
                                                                                carbomonocyclic-
                                                                                , diphenylester
                                                                                (accession
                                                                                number 261553).
J-18-0002......................          1  2/12/2018  CBI...............  (G) Ethanol         (G) Biofuel
                                                                            production.         producing
                                                                                Saccharomyces
                                                                                cerevisiae
                                                                                modified,
                                                                                genetically
                                                                                stable.
J-18-0003......................          1  2/12/2018  CBI...............  (G) Ethanol         (G) Biofuel
                                                                            production.         producing
                                                                                Saccharomyces
                                                                                cerevisiae
                                                                                modified,
                                                                                genetically
                                                                                stable.
----------------------------------------------------------------------------------------------------------------

    In Table II. of this unit, EPA provides the following information
(to the extent that such information is not claimed as CBI) on the NOCs
received by EPA during this period: The EPA case number assigned to the
NOC including whether the submission was an initial or amended
submission, the date the NOC was received by EPA, the date of
commencement provided by the submitter in the NOC, a notation of the
type of amendment (e.g., amendment to generic name, specific name,
technical contact information, etc.) and chemical substance identity.

                               Table II-- NOCs Received From 2/1/2018 to 2/28/2018
----------------------------------------------------------------------------------------------------------------
                                                     Commencement   If amendment, type of
             Case No.               Received  date       date             amendment          Chemical substance
----------------------------------------------------------------------------------------------------------------
P-03-0458.........................       2/19/2018       1/23/2018  .....................  (S) 2-Propenoic acid,
                                                                                2-methyl-, methyl
                                                                                ester, polymer with
                                                                                butyl 2-propenoate,
                                                                                ethyl 2-propenoate,
                                                                                zinc bis(2-methyl-2-
                                                                                propenoate) and zinc
                                                                                di-2-propenoate,
                                                                                2,2'-azobis[2-
                                                                                methylbutanenitrile]-
                                                                                and 2,2'-azobis[2-
                                                                                methylpropanenitrile
                                                                                ]- initiated.
P-07-0391.........................       2/21/2018      10/25/2007  .....................  (S) Propanoic acid, 3-
                                                                                hydroxy-2-
                                                                                (hydroxymethyl)-2-
                                                                                methyl-, polymer
                                                                                with dimethyl
                                                                                carbonate, 1,2-
                                                                                ethanediamine, 1,6-
                                                                                hexanediol, [alpha]-
                                                                                hydro-[infin]-
                                                                                hydroxypoly(oxy-1,4-
                                                                                butanediyl) and 1,1'-
                                                                                methylenebis[4-
                                                                                isocyanatocyclohexan
                                                                                e]compd. With N,N-
                                                                                diethylethanamine.
P-07-0403.........................        2/6/2018        5/1/2007  .....................  (G) Adipic carbamate.
P-07-0448.........................        2/1/2018      10/16/2007  .....................  (G) Secondary Amine
                                                                                Adduct.
P-09-0124.........................       2/20/2018       2/28/2011  .....................  (S) Methanone, (4-
                                                                                chlorophenyl) (4-
                                                                                hydroxyphenyl)-,
                                                                                Homopolymer.
P-12-0020.........................       2/16/2018       1/28/2014  .....................  (S) Propanoic aid, 3-
                                                                                hydroxy-2-
                                                                                (hydroxymethyl)-2-
                                                                                methyl-, polymer
                                                                                with 2,2-dimethyl-
                                                                                1,3-propanediol, 1,2-
                                                                                ethanediamine, 2-
                                                                                ethyl-2-
                                                                                (hydroxymethyl)-1,3-
                                                                                propanediol, 5-
                                                                                isocyanato-1-
                                                                                (isocyanatomethyl)-
                                                                                1,3,3-
                                                                                trimethylcyclohexane
                                                                                and 2-oxepanone,
                                                                                comp. with N,N-
                                                                                diethylethanamine.
P-12-0034.........................       2/16/2018       1/28/2014  .....................  (S) 2-Propenoic acid,
                                                                                2-methyl-, polymer
                                                                                with butyl 2-
                                                                                propenoate, ethyl 2-
                                                                                propenoate, methyl 2-
                                                                                methyl-2-propenoate
                                                                                and 2-methyl-2-
                                                                                propenamide.
P-12-0172.........................        2/2/2018       9/13/2012  .....................  (G) 1,4-
                                                                                Benzenedicarboxylic
                                                                                acid, polymer with
                                                                                hexanedioic acid, 1,
                                                                                6-hexanediol, 1,1'-
                                                                                methylenebis[4-
                                                                                isocyanatobenzene],
                                                                                and
                                                                                substituted[(alkylid
                                                                                ene)-di-4,1-
                                                                                phenylene] bis[-
                                                                                hydroxypoly[oxy(meth
                                                                                yl-1,2-
                                                                                ethanediyl)]].
P-12-0374.........................       2/13/2018       1/29/2018  .....................  (S) 1,6-
                                                                                Hexanediaminium, N1,
                                                                                N6-bis(2-
                                                                                hydroxymethylethyl)-
                                                                                N1,N1,N6,N6-
                                                                                tetramethyl-,
                                                                                hydroxide (1:2).
P-13-0047.........................       2/26/2018        2/8/2018  .....................  (G) Fatty acid amide.
P-13-0074.........................       2/26/2018       2/12/2018  .....................  (G) Fatty acid amide
                                                                                hydrochloride.
P-13-0325.........................        2/8/2018       1/22/2018  .....................  (G) Castor oil
                                                                                dehydrated, polymer
                                                                                with di-alkyl
                                                                                carbonate, alkyl
                                                                                diamine, alkyl diol,
                                                                                dihydroxyalkyl
                                                                                carboxylic acid and
                                                                                methylenebis
                                                                                [isocyanatocycloalka
                                                                                ne]-, compd. with
                                                                                triakylamine.
P-13-0570.........................       2/20/2018       3/26/2015  .....................  (S) 1,4-
                                                                                Benzinedicarbonyl
                                                                                dichloride, Polymer
                                                                                with 1,1' Oxybis
                                                                                [benzene].
P-13-0572.........................       2/20/2018       3/27/2015  .....................  (S) Benzoic acid, 3,4-
                                                                                diamino-,
                                                                                Homopolymer.
P-13-0886.........................        2/6/2018       1/19/2015  .....................  (G) Fluoroelastomer.
P-13-0924.........................        2/9/2018        3/9/2014  .....................  (G) Phosphated mono-
                                                                                and diglycerides
                                                                                (PMDG).

P-14-0301.........................        2/7/2018       1/29/2018  .....................  (G) Alkanedioic acid,
                                                                                polymer with
                                                                                alkanediol, hydroxy-
                                                                                (hydroxymethyl)-2-
                                                                                alkylcarboxylic
                                                                                acid,
                                                                                methylenebis[isocyan
                                                                                atocycloalkane] and
                                                                                alkyl-2-
                                                                                alkylalkenoate,
                                                                                compd. with alkyl
                                                                                morpholine.
P-14-0304.........................        2/7/2018       1/30/2018  .....................  (G) alkanedioic acid,
                                                                                polymer with N-(1,1-
                                                                                dimethyl-3-oxobutyl)-
                                                                                2-propenamide, 1,6-
                                                                                hexanediol, hydroxy-
                                                                                (hydroxymethyl)-2-
                                                                                alkyl carboxylic
                                                                                acid,
                                                                                methylenebis[isocyan
                                                                                atocycloalkane] and
                                                                                alkyl-2-alkyl-
                                                                                alkenoate, compd.
                                                                                With N,N-
                                                                                dialkylalkylamine.
P-14-0627.........................        2/5/2018        2/1/2018  .....................  (S) 1-Butylpyrrolidin-
                                                                                2-one.
P-15-0134.........................        2/8/2018        1/1/2018  .....................  (G) Cashew, nutshell
                                                                                liq., polymer with
                                                                                formaldehyde and
                                                                                amines.
P-15-0134A........................       2/28/2018        1/1/2018  Specific Name........  (G) Cashew, nutshell
                                                                                liq., polymer with
                                                                                formaldehyde and
                                                                                amines.
P-15-0277.........................       2/28/2018        2/5/2018  .....................  (S) 1,3-Butanediol, 3-
                                                                                methyl-, acetate.
P-15-0383.........................        2/2/2018       1/29/2018  .....................  (S) Butanedioic acid,
                                                                                2-methylene-,
                                                                                telomer with sodium
                                                                                phosphinate (1:1),
                                                                                sodium salt,
                                                                                decarboxylated.
P-15-0428.........................       2/20/2018       2/20/2018  .....................  (G) Alkyl pyridinium
                                                                                bromide.
P-15-0439.........................       2/20/2018        2/8/2018  .....................  (S) 1,4-Dioxane-2,5-
                                                                                dione, 3,6-dimethyl-
                                                                                , (3S,6S)-, polymer
                                                                                with 2-oxepanone.
P-16-0044.........................        2/1/2018        4/7/2017  .....................  (G) Isocyanate
                                                                                functional urethane
                                                                                prepolymer.
P-16-0516.........................        2/6/2018       1/26/2018  .....................  (S) 2-
                                                                                Pyridinecarboxylic
                                                                                acid, 4-amino-6-(4-
                                                                                chloro-2-fluoro-3-
                                                                                methoxyphenyl)-5-
                                                                                fluoro-,
                                                                                phenylmethyl ester,
                                                                                hydrochloride (1:1).
P-16-0573.........................       2/27/2018        2/7/2018  .....................  (G) Polyamine
                                                                                polyacid adducts.
P-17-0228.........................       2/22/2018       1/18/2018  .....................  (G) 2'-fluoro-4''-
                                                                                alkyl-4-propyl-
                                                                                1,1':4',1''-
                                                                                terphenyl.
P-17-0229.........................       2/22/2018       1/18/2018  .....................  (G) 4-ethyl-2'-fluoro-
                                                                                4''-alkyl-
                                                                                1,1':4',1''-
                                                                                terphenyl.
P-17-0257.........................       2/27/2018       1/31/2018  .....................  (S) Single Walled
                                                                                Carbon Nanotube.
P-17-0308.........................       2/20/2018       1/10/2018  .....................  (S) 2-Pentanone,
                                                                                O,O',O''-
                                                                                (ethenylsilylidyne)t
                                                                                rioxime.
P-17-0308A........................       2/28/2018       1/10/2018  Specific Name........  (S) 2-Pentanone,
                                                                                2,2',2''-[O,O',O''-
                                                                                (ethenylsilylidyne)t
                                                                                rioxime].
P-17-0309.........................       2/20/2018       1/10/2018  .....................  (S) 2-Pentanone,
                                                                                2,2',2''-[O,O',O''-
                                                                                (methylsilylidyne)tr
                                                                                ioxime]
----------------------------------------------------------------------------------------------------------------

    In Table III. of this unit, EPA provides the following information
(to the extent such information is not subject to a CBI claim) on the
test information received by EPA during this time period: The EPA case
number assigned to the test information; the date the test information
was received by EPA, the type of test information submitted, and
chemical substance identity.

                         Table III--Test Information Received From 2/1/2018 to 2/28/2018
----------------------------------------------------------------------------------------------------------------
               Case No.                  Received date     Type of test information        Chemical substance
----------------------------------------------------------------------------------------------------------------
P-87-1436.............................       2/28/2018  QSAR Assessment Report on       (S) Dodecanoic acid,
                                                         Vinyl Laurate; Skin             ethenyl ester.
                                                         Sensitization; Sub-Chronic
                                                         (13 Week) Oral Toxicity
                                                         Study; Aquatic Toxicity--
                                                         Daphnia; Aquatic Toxicity--
                                                         Daphnia Reproductive, Aquatic
                                                         Toxicity--Algal Growth;
                                                         Combined Repeated Dose
                                                         Toxicity Study with the
                                                         Reproduction/Developmental
                                                         Toxicity Screening Test (OECD
                                                         422); Chromosome Aberration
                                                         Test (OECD 473); Gene
                                                         Mutation Assay (OECD 476);
                                                         Micronucleus Test (OECD 474);
                                                         Prenatal Developmental
                                                         Toxicity Study (OECD 414);
                                                         Ready Biodegradability (OECD
                                                         301); Dermal Irritation/
                                                         Corrosion (OECD 404);
                                                         Bacterial Reverse Mutation
                                                         Assay (Ames Test) (OECD 471);
                                                         Fish Acute Toxicity (OECD
                                                         203); Activated Sludge Test
                                                         (OECD 209); Acute Oral
                                                         Toxicity (OECD 401); Eye
                                                         Irritation (OECD 405); Acute
                                                         Dermal Toxicity (OECD 402).
P-14-0321.............................        2/7/2018  Quarterly Ambient Air           (S) 2-Chloro-1,1,1,2-
                                                         Monitoring Report.              Tetrafluoropropane(244b
                                                                                b).
P-14-0323.............................        2/7/2018  Quarterly Ambient Air           (S) 1-Propene, 2-chloro-
                                                         Monitoring Report.              3,3,3-trifluoro-.
P-15-0054.............................       2/19/2018  Test Plan for 2018--physical    (G) Carbon Nanotube.
                                                         characteristics of the CNT
                                                         (TEM; SEM; AFM; Surface Area;
                                                         XRD; Raman; XPS; EDS; ICP;
                                                         Zeta Potential & ZDS).

P-16-0393.............................       2/20/2018  Report for Fish, Juvenile       (G) Di-substituted
                                                         Growth Test of CBI (OECD        benzenedicarboxylic
                                                         211); Report for Daphnia sp.,   acid ester.
                                                         Reproduction Test (OECD 215).
P-16-0543.............................       2/28/2018  January 2018 Exposure           (G) Halogenophos-
                                                         Monitoring Results.            phoric acid metal salt.
P-17-0193.............................       2/26/2018  Reproductive/Developmental      (G) Pentaerythritol
                                                         Data on Potential Hydrolysis    Ester of Mixed Linear
                                                         Products.                       and Branched Carboxylic
                                                                                Acids,
                                                                                Dipentaerythritol Ester
                                                                                of Mixed Linear and
                                                                                Branched Carboxylic
                                                                                Acids.
P-17-0329.............................       2/12/2018  90-day Repeated Dose Oral       (G) Substituted
                                                         Toxicity (OECD 408);            haloaromatic
                                                         Activated Sludge Respiration    trihaloalkyl-aromatic
                                                         Inhibition (OECD 209); Acute    alkanone.
                                                         Dermal Irritation (OECD 404);
                                                         Acute Dermal Toxicity(OECD
                                                         402); Acute Eye Irritation
                                                         (OECD 405); Acute Inhalation
                                                         Toxicity (OECD 436); Acute
                                                         Oral Toxicity (OECD 423);
                                                         Acute Toxicity in Fish (OECD
                                                         203); Adsorption-Desorption
                                                         (OECD 106); Algae Growth
                                                         Inhibition (OECD 201);
                                                         Bacterial Reverse Mutation
                                                         Assay (OECD 471);
                                                         Bioaccumulation Study (OECD
                                                         305); Chronic Toxicity in
                                                         Fish (OECD 212); Daphnia
                                                         magna Reproduction (OECD
                                                         211); Daphnia sp. Acute
                                                         Immobilization (OECD 202);
                                                         Density Test (OECD 109);
                                                         Flammability; Earthworm Acute
                                                         Toxicity (OECD 207); Glove
                                                         Permeation Testing;
                                                         Hydrolysis as a function of
                                                         pH (OECD 111); In Vitro
                                                         Mammalian Chromosomal
                                                         Aberration (OECD 473);
                                                         Inherent Biodegradability
                                                         (OECD 302); Laser Particle
                                                         Size Distribution; Melting
                                                         Point (OECD 102); Mouse Bone
                                                         Marrow Polychromatic
                                                         Erythrocyte Micronucleus
                                                         (OECD 474); N-octanol-water
                                                         Partition Coefficient (OECD
                                                         117); Oral Prenatal
                                                         Developmental Toxicity (OECD
                                                         414); Ready Biodegradability
                                                         (OECD 301); Seed Germination-
                                                         Root Elongation (OECD 299);
                                                         Skin Sensitization in Guinea
                                                         Pig (OECD 406); Solid
                                                         Relative Self-Ignition
                                                         Temperature; HPLC/MS/IR/NMR
                                                         Spectral Test Report; Two
                                                         Generation Reproduction Study
                                                         in Rats; Water Solubility
                                                         (OECD 105); Whole-course
                                                         Toxicokinetics (OECD 417).
P-17-0364.............................       2/22/2018  Dynamic Data for Particle Size  (G) Dicyloalkyl-alkane-
                                                         Distribution.                   di-isocyanate
                                                                                homopolymer, alkyl
                                                                                alcohol and polyalkyl
                                                                                glycol mono-alkyl-ether-
                                                                                blocked.
P-18-0009.............................       2/13/2018  Reproduction/Development        (G) Phosphonic acid,
                                                         Toxicity Screening Test (OECD   dimethyl ester, polymer
                                                         421).                           with alkyl diols.
P-18-0047.............................       2/13/2018  90-day oral toxicity in         (S) 1,2-Ethanediol, 1,2-
                                                         rodents (OECD 408) and          dibenzoate.
                                                         Combined Repeated Dose
                                                         Toxicity Study with the
                                                         Reproduction/Developmental
                                                         Toxicity Screening Test (OECD
                                                         422).
P-18-0093.............................       2/13/2018  Particle Size Analysis........  (G)
                                                                                Pentacyclo[<IP_ADDRESS>,9.1
                                                                                5,15.17,13]octasiloxane
                                                                                , 1,3,5,7,9,11,13,15-
                                                                                octakis
                                                                                (polyfluoroalkyl)-
----------------------------------------------------------------------------------------------------------------

    If you are interested in information that is not included in these
tables, you may contact EPA's technical information contact or general
information contact as described under FOR FURTHER INFORMATION CONTACT
to access additional non-CBI information that may be available.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: May 15, 2018.
Pamela Myrick,
Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2018-12059 Filed 6-4-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 93 (Friday, May 13, 2011)]
[Rules and Regulations]
[Pages 27910-27914]
[FR Doc No: 2011-11435]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2009-0669; FRL-8871-5]
RIN 2070-AB27

Modification of the Significant New Uses of 2-Propen-1-one, 1-(4-
morpholinyl)-

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is finalizing an amendment to the significant new use rule
(SNUR) under the Toxic Substances Control Act (TSCA) for 2-Propen-1-
one, 1-(4-morpholinyl)- (CAS No. 5117-12-4). This action requires
persons who intend to manufacture, import, or process the chemical
substance for a use that is designated as a significant new use by this
final rule to notify EPA at least 90 days before commencing that
activity. EPA believes that this action is necessary because the
chemical substance may be hazardous to human health. The required
notification would provide EPA with the opportunity to evaluate the
intended use and, if necessary, to prohibit or limit that activity
before it occurs.

DATES: This final rule is effective June 13, 2011.

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPPT-2009-0669. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket
Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave.,
NW., Washington, DC. The EPA/DC Public Reading Room hours of operation
are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number of the EPA/DC Public Reading Room is
(202) 566-1744, and the telephone number for the OPPT Docket is (202)
566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Tracey Klosterman, Chemical Control Division (7405M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-2209; e-mail address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    You may be potentially affected by this action if you manufacture,
import, process, or use 2-Propen-1-one, 1-(4-morpholinyl)-(CAS No.
5117-12-4). Potentially affected entities may include, but are not
limited to:
     Manufacturers, importers, or processors of the subject
chemical substance (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Sec.  721.5. If you
have any questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
    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;
see also 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 a modified

SNUR 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 the
chemical substance that is the subject of a final rule are subject to
the export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)) (see Sec.  721.20), and must comply with the export
notification requirements in 40 CFR part 707, subpart D.

II. Background

A. What action is the Agency taking?

    EPA is finalizing an amendment to the SNUR for the chemical
substance identified as 2-Propen-1-one, 1-(4-morpholinyl)- (PMN P-95-
169; CAS No. 5117-12-4) codified at Sec.  721.5185. This final action
requires persons who intend to manufacture, import, or process the
subject chemical substance for an activity that is designated as a
significant new use by this final rule to notify EPA at least 90 days
before commencing that activity.
    In addition, EPA is revising the name of the chemical substance as
it appears at Sec.  721.5185 to reflect the correct Chemical Abstracts
(CA) Index name. 2-Propen-1-one, 1-(4-morpholinyl)- is the correct CA
Index name for the chemical substance represented by CAS No. 5117-12-4
as it appears on the TSCA Inventory. The chemical name Morpholine, 4-
(1-oxo-2-propenyl)-, which currently appears at Sec.  721.5185, is a
synonym for CAS No. 5117-12-4.
    This rule was proposed in the Federal Register of November 5, 2010
(75 FR 68306) (FRL-8849-7). EPA received no public comments in response
to the proposal. Therefore, the Agency is issuing a final SNUR as
proposed that:
    1. Revises the CA Index name for the chemical substance represented
by CAS No. 5117-12-4 from Morpholine, 4-(1-oxo-2-propenyl)- to 2-
Propen-1-one, 1-(4-morpholinyl)-.
    2. Identifies those forms of the PMN substance that are exempt from
the provisions of the SNUR. These exemptions apply to quantities of the
PMN substance after it has been completely reacted (cured).
    3. Revises the protection in the workplace requirements under Sec.
721.63 to remove all requirements for respiratory protection.
    4. Revises the hazard communication requirements under Sec.  721.72
to remove all requirements pertaining to respiratory protection.
    5. Revises the industrial, commercial, and consumer requirements
under Sec.  721.80 to remove all requirements pertaining to domestic
manufacture, and aggregate manufacture and import volumes.
    6. Removes all disposal requirements under Sec.  721.85.
    7. Removes all release to water requirements under Sec.  721.90.
    8. Revises the recordkeeping requirements under Sec.  721.125 to
reflect the aforementioned modified SNUR requirements.

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 IV. of this document. 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, import, or
process the chemical substance for that use. Persons who must report
are described in Sec.  721.5.

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 final
rule. Provisions relating to user fees appear at 40 CFR part 700.
According to Sec.  721.1(c), persons subject to these SNURs must comply
with the same notice 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 may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it
has received the SNUN. If EPA does not take action, EPA is required
under TSCA section 5(g) to explain in the Federal Register its reasons
for not taking action.
    Chemical importers are subject to the TSCA section 13 (15 U.S.C.
2612) import certification requirements codified at 19 CFR 12.118
through 12.127; see also 19 CFR 127.28 (the corresponding EPA policy
appears at 40 CFR part 707, subpart B). Chemical importers must certify
that the shipment of the chemical substance complies with all
applicable rules and orders under TSCA. Importers of chemical
substances subject to a modified SNUR must certify their compliance
with the SNUR requirements. In addition, any persons who export or
intend to export a chemical substance identified in a modified SNUR are
subject to the export notification provisions of TSCA section 12(b) (15
U.S.C. 2611(b)) (see Sec.  721.20) and must comply with the export
notification requirements in 40 CFR part 707, subpart D.

III. Rationale and Objectives of the Rule

A. Rationale

    Under the terms of the TSCA section 5(e) consent order for P-95-
0169, the PMN submitter completed and submitted required testing for
EPA review. Based on these new data, concerns remain for possible
effects to the liver, testes, kidney, and blood from dermal exposure.
However, EPA no longer has substantial human health concerns for
mutagenicity and neurotoxicity. In addition, based on these data,
Agency concerns for carcinogenicity by inhalation were reduced, and
further mitigated by retaining the original consent order prohibition
of industrial processing and use in a non-enclosed process and any use
application methods that generate a vapor, mist, or aerosol form of the
PMN substance. Finally, the Agency re-reviewed the environmental
toxicity profile for the PMN substance and as a result of this
evaluation could no longer make a ``may present unreasonable risk''
finding for releases of the PMN substance to surface waters. As a
result of the aforementioned review, EPA issued a modified TSCA section
5(e) consent order, which became effective on May 9, 2006. These
modifications to the consent order are the same being made to this SNUR
and are described in Unit II.A.
    In addition, the Agency received a SNUN (S-08-07) for the subject
chemical substance. The significant new use identified in the notice
was release to water for the generic (non-confidential) use of
``contained use in energy production.'' The 90-day review period for
the SNUN expired with the Agency not taking action on the ``significant
new use'' of release of the substance to water. This decision by the
Agency is consistent with the modifications made to the consent order
for P-95-169 and today's SNUR.
    Pursuant to Sec.  721.185(a)(5) and as described in Unit II. of the
proposed rule (see the Federal Register of

November 5, 2010 (75 FR 68306)), the Agency has examined new
information and reexamined the test data and other information
supporting its finding under section 5(e)(1)(A)(ii)(I) of TSCA for the
chemical substance 2-Propen-1-one, 1-(4-morpholinyl)-. EPA determined
that existing data no longer supports a finding that certain activities
involving the substance ``may present an unreasonable risk'' of injury
to human health and the environment required under section 5(e)(1)(A)
of TSCA.

B. Objectives

    EPA is issuing this modified SNUR for 2-Propen-1-one, 1-(4-
morpholinyl)- (PMN P-95-169; CAS No. 5117-12-4) because the Agency
wants to achieve the following objectives with regard to the
significant new uses designated in this final rule:
     EPA will receive notice of any person's intent to
manufacture, import, 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,
importing, or processing a listed chemical substance for the described
significant new use.
     EPA will be able to regulate prospective manufacturers,
importers, or processors of a listed chemical substance before the
described significant new use of that chemical substance occurs,
provided that regulation is warranted pursuant to TSCA sections 5(e),
5(f), 6, or 7.
     EPA will ensure that all manufacturers, importers, and
processors of the same chemical substance that is subject to a TSCA
section 5(e) consent order are subject to similar requirements.

IV. 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 2-
Propen-1-one, 1-(4-morpholinyl)- subject to this modified SNUR, EPA
considered relevant information about the toxicity of the chemical
substance, likely human exposures and environmental releases associated
with possible uses, taking into consideration the four bulleted TSCA
section 5(a)(2) factors listed in this unit.

V. Applicability of Rule to Uses Occurring Before Effective Date of the
Final Rule

    As discussed in the Federal Register of April 24, 1990 (55 FR
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is
best served by designating a use as a significant new use as of the
date of publication of the proposed SNUR rather than as of the
effective date of the final rule. If uses begun after publication were
considered ongoing rather than new, it would be difficult for EPA to
establish SNUR notice requirements because a person could defeat the
SNUR by initiating the proposed significant new use before the rule
became effective, and then argue that the use was ongoing before the
effective date of the final rule.
    Any person who began commercial manufacture, import, or processing
of the chemical substance 2-Propen-1-one, 1-(4-morpholinyl)- (CAS No.
5117-12-4) for any of the significant new uses designated in the
proposed SNUR modification after the date of publication of the
proposed SNUR must stop that activity before the effective date of this
final rule. Persons who ceased those activities will have to meet all
SNUR notice requirements and wait until the end of the notification
review period, including all extensions, before engaging in any
activities designated as significant new uses. If, however, persons who
began manufacture, import, or processing of the chemical substance
between the date of publication of the proposed SNUR modification and
the effective date of this modified SNUR meet the conditions of advance
compliance as codified at Sec.  721.45(h), those persons would be
considered to have met the modified SNUR requirements for those
activities.

VI. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. There are two
exceptions:
    1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
    2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
    In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (see Sec.
[emsp14]720.50). However, upon review of PMNs and SNUNs, the Agency has
the authority to require appropriate testing. In this case, EPA
recommends persons, before performing any testing, to consult with the
Agency pertaining to protocol selection.
    The recommended testing specified in Unit II.A. of the proposed
rule may not be the only means of addressing the potential risks of the
chemical substance. However, SNUNs submitted without any test data may
increase the likelihood that EPA will respond by taking 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 substance.
     Potential benefits of the chemical substance.
     Information on risks posed by the chemical substance
compared to risks posed by potential substitutes.

VII. SNUN Submissions

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

VIII. Economic Analysis

    EPA evaluated the potential costs of establishing SNUN requirements
for potential manufacturers, importers, and processors of the chemical
substance during the development of the direct final rule. The Agency's
complete Economic Analysis is available in the docket under docket ID
number EPA-HQ-OPPT-2009-0669.

IX. Statutory and Executive Order Reviews

A. Executive Order 12866

    This action modifies a SNUR for a chemical substance that is the
subject of a PMN and TSCA section 5(e) consent order. 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

    According to the Paperwork Reduction Act (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,
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

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation
of this SNUR will not have a significant adverse economic impact on a
substantial number of small entities. The rationale supporting this
conclusion is discussed in this unit. 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
over 1,400 SNURs, the Agency receives on average only 5 notices per
year. Of those SNUNs submitted from 2006-2008, only one appears to be
from a small entity. In addition, the estimated reporting cost for
submission of a SNUN (see Unit VIII.) is minimal regardless of the size
of the firm. Therefore, EPA believes that the potential economic
impacts of complying with this 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
modified 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

    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 final rule.
As such, EPA has determined that this final rule does not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
affect on small governments subject to the requirements of sections
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4).

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 final rule does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
final rule 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 final rule.

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

    In addition, since this action does not involve any technical
standards, section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA), Public Law 104-113, 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).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and
the Comptroller General of the United States. 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 rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 721

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

    Dated: April 29, 2011.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.

    Therefore, 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. Amend Sec.  721.5185 as follows:
0
a. Revise the section heading.
0
b. Revise paragraphs (a)(1) and (a)(2)(i).
0
c. Add paragraph (a)(2)(ii).
0
d. Revise paragraph (a)(2)(iii).
0
e. Remove paragraphs (a)(2)(iv), (a)(2)(v), and (a)(2)(vi).
0
f. Revise paragraph (b)(1).
    The revisions and addition read as follows:

Sec.  721.5185  2-Propen-1-one, 1-(4-morpholinyl)-.

    (a) * * *
    (1) The chemical substance identified as 2-Propen-1-one, 1-(4-
morpholinyl)-(PMN P-95-169; CAS No. 5117-12-4) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this rule do not apply to
quantities of the PMN substance after it has been completely reacted
(cured).
    (2) * * *
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(2)(iv), (a)(3)(i), (a)(3)(ii), (a)(4),
(a)(6)(v), (b) (concentration set at 1.0 percent), and (c). Safety 4/4H
EVOH/PE laminate, Ansell Edmont Neoprene number 865, and Solvex Nitrile
Rubber number 275 gloves have been tested in accordance with the
American Society for Testing Materials (ASTM) F739 method and found by
EPA to satisfy the consent orders and Sec.  721.63(a)(2)(i)
requirements for dermal protection to 100 percent PMN substance. Gloves
and other dermal protection may not be used for a time period longer
than they are actually tested and must be replaced at the end of each
work shift. For additional dermal protection materials, a company must
submit all test data to the Agency and must receive written Agency
approval for each type of material tested prior to use of that material
as worker dermal protection. However, for the purposes of determining
the imperviousness of gloves, up to 1 year after the commencement of
commercial manufacture or import, the employer may use the method
described in Sec.  721.63(a)(3)(ii), thereafter, they must use the
method described in Sec.  721.63(a)(3)(i).
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72 (a), (b), (c), (d), (e) (concentration set at 1.0
percent), (f), (g)(1)(iv), (g)(1)(vi), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (a), (c), and (y)(1).
    (b) * * *
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a) through (i) are applicable to manufacturers, importers, and
processors of this chemical substance.
* * * * *
[FR Doc. 2011-11435 Filed 5-12-11; 8:45 am]
BILLING CODE 6560-50-P