[Federal Register Volume 87, Number 123 (Tuesday, June 28, 2022)]
[Notices]
[Pages 38391-38396]
[FR Doc No: 2022-13779]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2022-0132; FRL-9411-03-OCSPP]

Certain New Chemicals; Receipt and Status Information for May
2022

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is required under the Toxic Substances Control Act (TSCA)
to make information publicly available and to publish information in
the Federal Register pertaining to submissions under TSCA, 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
(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 05/01/2022 to 05/31/2022.

DATES: Comments identified by the specific case number provided in this
document must be received on or before July 28, 2022.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2022-0132, and the specific case number for the
chemical substance related to your comment, through the Federal
eRulemaking Portal at https://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. To make
special arrangements for hand delivery or delivery of boxed
information, please follow the instructions at https://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or
visiting the docket, along with more information about dockets
generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Jim Rahai, Project Management
and Operations Division (MC 7407M), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What action is the Agency taking?

    This document provides the receipt and status reports for the
period from 05/01/2022 to 05/31/2022. 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/MCANs
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/MCANs 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 please 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: https://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/MCANs (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 https://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/MCANs
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/MCANs 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 that have passed an initial screening 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 screened 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 Approved * From 05/01/2022 to 05/31/2022
----------------------------------------------------------------------------------------------------------------
                                             Received                                               Chemical
            Case No.              Version      date        Manufacturer            Use             substance
----------------------------------------------------------------------------------------------------------------
P-19-0141A.....................         8   05/05/2022  CBI...............  (S) For use in     (S) Phosphoric
                                                                             metal treatment    Acid,
                                                                             coatings for       manganese(2+)
                                                                             lubrication and    salt (2:3);(S)
                                                                             corrosion          Phosphoric acid,
                                                                             protection.        manganese(2+)
                                                                                salt (4:5).
P-21-0195......................         4   05/04/2022  CBI...............  (G) Primary        (S) Corn, germ,
                                                                             component of       meal.
                                                                             retail consumer
                                                                             product for
                                                                             animals.
P-21-0196A.....................         2   05/25/2022  CBI...............  (S) Additive for   (G) Oxathiole,
                                                                             use in battery     oxide.
                                                                             electrolyte
                                                                             formulations.
P-21-0216A.....................         3   05/22/2022  LG Chem America,    (G) Additive in    (G) Multi-walled
                                                         Inc.                electrode          carbon
                                                                             materials,         nanotubes.
                                                                             plastics.
P-21-0217A.....................         3   05/22/2022  LG Chem America,    (G) Additive in    (G) Multi-walled
                                                         Inc.                electrode          carbon
                                                                             materials,         nanotubes.
                                                                             thermoplastics
                                                                             and Component in
                                                                             electrodes.
P-22-0014......................         3   05/22/2022  CBI...............  (G) Precursor....  (G) sodium
                                                                                bis(chloropropan
                                                                                ediol)
                                                                                phosphate.
P-22-0074......................         2   04/26/2022  Wilbur Ellis......  (G) Agricultural   (S) Phosphonic
                                                                             chemical.          acid,
                                                                                manganese(2+)
                                                                                salt (1:1).
P-22-0075......................         2   05/11/2022  Elantas pdg, Inc..  (S) Isolated       (S) 1H-Isoindole-
                                                                             intermediate       1,3(2H)-dione,
                                                                             used as a          3a,4,7,7a-
                                                                             monomer in the     tetrahydro-2-(2-
                                                                             production of a    hydroxyethyl)-.
                                                                             monomer free
                                                                             unsaturated
                                                                             polyester resin.
P-22-0077......................         2   05/24/2022  CBI...............  (G) Chemical       (G) magnesium
                                                                             Intermediate.      salt of alkyl
                                                                                substituted
                                                                                hexanol.
P-22-0078......................         2   04/28/2022  CBI...............  (S) Dispersing     (G) Oxirane, 2-
                                                                             agent.             methyl-, polymer
                                                                                with oxirane,
                                                                                mono-isoalkyl
                                                                                ethers,
                                                                                phosphates,
                                                                                salt.
P-22-0078A.....................         3   05/16/2022  CBI...............  (S) Dispersing     (G) Oxirane, 2-
                                                                             agent for          methyl-, polymer
                                                                             pesticide          with oxirane,
                                                                             formulators.       mono-isoalkyl
                                                                                ethers,
                                                                                phosphates,
                                                                                salt.

P-22-0078A.....................         4   05/17/2022  CBI...............  (S) Dispersing     (G) Oxirane, 2-
                                                                             agent for          methyl-, polymer
                                                                             pesticide          with oxirane,
                                                                             formulators.       mono-isoalkyl
                                                                                ethers,
                                                                                phosphates,
                                                                                salt.
P-22-0079......................         4   05/17/2022  Galata Chemicals,   (S) Stabilizer     (G) Pyridine
                                                         LLC.                for PVC            carboxylate
                                                                             compounds.         aliphatic
                                                                                diester.
P-22-0080......................         2   04/28/2022  Huntsman            (S) As an          (S) Poly(oxy-1,2-
                                                         International,      industrial         ethanediyl),
                                                         LLC.                intermediate       alpha,alpha'-
                                                                             used in the        (iminodi-2,1-
                                                                             manufacture of     ethanediyl)bis[o
                                                                             polyamides as a    mega-(2-
                                                                             monomer.           aminoethoxy)-
                                                                                ;(S) Poly(oxy-
                                                                                1,2-ethanediyl),
                                                                                alpha-(2-
                                                                                aminoethyl)-
                                                                                omega-(2-
                                                                                aminoethoxy)-.
P-22-0080A.....................         3   05/19/2022  Huntsman            (S) As an          (S) Poly(oxy-1,2-
                                                         International,      industrial         ethanediyl), ,'-
                                                         LLC.                intermediate       (iminodi-2,1-
                                                                             used in the        ethanediyl)bis[-
                                                                             manufacture of     (2-aminoethoxy)-
                                                                             polyamides as a    ;(S) Poly(oxy-
                                                                             monomer.           1,2-ethanediyl),
                                                                                -(2-aminoethyl)--
                                                                                (2-aminoethoxy)-
                                                                                .
P-22-0081......................         2   05/03/2022  CBI...............  (S) Light and      (S) 1,3-
                                                                             peroxide cured     Propanediol,2,2-
                                                                             adhesives,         dimethyl-,
                                                                             Component of       polymer with
                                                                             formulation for    alpha-hydro-
                                                                             3D printing with   omega-
                                                                             stereolithograph   hydroxypoly(oxy-
                                                                             y process.         1,4-butanediyl)
                                                                            (G) Component of    and 1,1-
                                                                             light cured        methylenebis[4-
                                                                             adhesives..        isocyanatocycloh
                                                                                exane], 2-
                                                                                hydroxyethyl
                                                                                methacrylate-
                                                                                blocked.;(S) 1,4-
                                                                                Cyclohexanedimet
                                                                                hanol, polymer
                                                                                with 2,2-
                                                                                dimethyl-1,3-
                                                                                Propanediol,alph
                                                                                a-hydro-omega-
                                                                                hydroxypoly(oxy-
                                                                                1,4-butanediyl)
                                                                                and 1,1-
                                                                                methylenebis[4-
                                                                                isocyanatocycloh
                                                                                exane], 2-
                                                                                hydroxyethyl
                                                                                methacrylate-
                                                                                blocked;(S) 1,4-
                                                                                cyclohexanedimet
                                                                                hanol, polymer
                                                                                with alpha-hydro-
                                                                                omega-
                                                                                hydroxypoly(oxy-
                                                                                1,4-butanediyl)
                                                                                and 1,1-
                                                                                methylenebis[4-
                                                                                isocyanatocycloh
                                                                                exane], 2-
                                                                                hydroxyethyl
                                                                                methacrylate-
                                                                                blocked.;(S)
                                                                                poly(oxy-1,4-
                                                                                butanediyl),
                                                                                alpha-hydro-
                                                                                omega-hydroxy-
                                                                                polymer with 1,1-
                                                                                methylenebis[4-
                                                                                isocyanatocycloh
                                                                                exane], 2-
                                                                                hydroxyethyl
                                                                                methacrylate-
                                                                                blocked.
P-22-0083......................         2   05/03/2022  CBI...............  (G) Perfume......  (S) Oils,
                                                                                sandalwood,
                                                                                santalene
                                                                                synthase-
                                                                                modified
                                                                                Rhodobacter
                                                                                sphaeroides-
                                                                                fermented, from
                                                                                D-Glucose,
                                                                                oxidized.
P-22-0083A.....................         3   05/13/2022  CBI...............  (G) Perfume......  (S) Oils,
                                                                                sandalwood,
                                                                                santalene
                                                                                synthase-
                                                                                modified
                                                                                Rhodobacter
                                                                                sphaeroides-
                                                                                fermented, from
                                                                                D-Glucose,
                                                                                oxidized.
P-22-0084......................         1   04/27/2022  CBI...............  (G) Performance    (G)
                                                                             additive.          Diallyldimethyla
                                                                                mmonium
                                                                                chloride,
                                                                                polymer with
                                                                                acrylic acid and
                                                                                methacrylic acid
                                                                                derivatives.
P-22-0085......................         1   04/29/2022  CBI...............  (S) Site limited   (S) Ethane, 1,2-
                                                                             Intermediate to    dibromo-1,1-
                                                                             be further         difluoro-.
                                                                             reacted into
                                                                             final product.
P-22-0086......................         2   05/11/2022  SHIN-ETSU Microsi.  (G) Contained use  (G)
                                                                             for                Phenoxathiinium,
                                                                             microlithography   10-phenyl-, 5-
                                                                             for electronic     alkyl-2-alkyl-4-
                                                                             device             (2,4,6-
                                                                             manufacturing.     substituted tri-
                                                                                carbopolycycle,
                                                                                hetero-
                                                                                acid)benzenesulf
                                                                                onate (1:1).
P-22-0087......................         1   05/03/2022  Hubergroup........  (S) Binder for     (S) Fatty acids,
                                                                             energy-curing      C18-unsatd.,
                                                                             printing inks.     dimers, polymers
                                                                                with acrylic
                                                                                acid, bisphenol
                                                                                A,
                                                                                epichlorohydrin,
                                                                                oleic acid, 2,2'-
                                                                                [oxybis(methylen
                                                                                e)]bis[2-ethyl-
                                                                                1,3-propanediol]
                                                                                and phthalic
                                                                                anhydride.
P-22-0088......................         1   05/03/2022  Hubergroup........  (S) Binder for     (S) Fatty acids,
                                                                             energy-curing      C18-unsatd.,
                                                                             printing inks.     dimers, polymers
                                                                                with acrylic
                                                                                acid, bisphenol
                                                                                A,
                                                                                epichlorohydrin,
                                                                                oleic acid,
                                                                                pentaerythritol
                                                                                and phthalic
                                                                                anhydride.
P-22-0089......................         4   05/10/2022  Allnex USA, Inc...  (S) UV Cured       (G) Carboxylic
                                                                             resin for dry      acid substituted
                                                                             toner printing.    carbomonocycles,
                                                                                polymer with
                                                                                dialkyl-
                                                                                alkanediol and
                                                                                alkanediol,
                                                                                hydroxy-alkyl-
                                                                                oxo-
                                                                                alkenyl)oxy]alky
                                                                                l ester.
P-22-0090......................         1   05/06/2022  CBI...............  (G) Perfume (G)    (S) 4,8,11-
                                                                             Perfume.           Dodecatrienal.
P-22-0091......................         4   05/10/2022  Allnex USA, Inc...  (S) UV Cured       (G) Alkanol,
                                                                             resin for dry      polymer with
                                                                             toner printing.    isocyanato-
                                                                                (isocyanatoalkyl
                                                                                )-
                                                                                trialkylcarbomon
                                                                                ocycle, alkylene
                                                                                glycol
                                                                                monoacrylate-
                                                                                blocked.
P-22-0092......................         2   05/12/2022  CBI...............  (G) Coating        (G) Ferrous
                                                                             material.          lithiophilite
                                                                                carbide.
P-22-0094......................         2   05/20/2022  CBI...............  (G) Contained use  (S) Cadmium tin
                                                                             as a sputtering    oxide (Cd2SnO4).
                                                                             material.
P-22-0095......................         1   05/18/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates.
P-22-0096......................         1   05/18/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates.

P-22-0097......................         1   05/18/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates.
P-22-0098......................         1   05/18/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates.
P-22-0099......................         1   05/18/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates.
P-22-0100......................         1   05/18/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates.
P-22-0101......................         1   05/18/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0101A.....................         2   05/23/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0102......................         1   05/18/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0102A.....................         2   05/23/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0103......................         1   05/18/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0103A.....................         2   05/23/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0104......................         1   05/18/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0104A.....................         2   05/23/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0105......................         1   05/18/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0105A.....................         2   05/23/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0106......................         1   05/18/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0106A.....................         2   05/23/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0107......................         1   05/18/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0107A.....................         2   05/23/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0108......................         1   05/18/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0108A.....................         2   05/23/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0109......................         1   05/18/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0109A.....................         2   05/23/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0110......................         1   05/18/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0110A.....................         2   05/23/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0111......................         1   05/18/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0111A.....................         2   05/23/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.

P-22-0112......................         1   05/18/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
P-22-0112A.....................         2   05/23/2022  Locus Fermentation  (G) Surfactant     (G) Glycolipids,
                                                         Solutions.          for consumer,      sophorose-
                                                                             industrial,        contg., yeast-
                                                                             commercial,        fermented, from
                                                                             applications.      glycerides and
                                                                                carbohydrates,
                                                                                salts.
SN-16-0013A....................         4   05/17/2022  CBI...............  (G) Surfactant...  (G)
                                                                                Polyfluorinated
                                                                                alkyl quaternary
                                                                                ammonium
                                                                                chloride.
SN-20-0003A....................         9   05/13/2022  CBI...............  (S) An anionic     (S) 1-
                                                                             fluorosurfactant   Propanesulfonic
                                                                             used in            acid, 2-methyl-2-
                                                                             firefighting       [[1-oxo-3-
                                                                             foam               [(3,3,4,4,5,5,6,
                                                                             concentrates       6,7,7,8,8,8-
                                                                             such as AFFF       tridecafluorooct
                                                                             (Aqueous Film      yl)thio]propyl]a
                                                                             Forming Foam)      mino]-, sodium
                                                                             and AR-AFFF        salt (1:1).
                                                                             (Alcohol
                                                                             Resistant
                                                                             Aqueous Fim
                                                                             Forming Foam).
SN-22-0004.....................         1   04/29/2022  HPC Holdings, Inc.  (S) Carrier Fluid  (S) Propane,
                                                                             for coating-type   1,1,1,3,3,3-
                                                                             vapor degreaser,   hexafluoro-2-
                                                                             process solvent    methoxy-.
                                                                             (Closed Systems).
SN-22-0005.....................         1   05/18/2022  CBI...............  (G) Dispersant     (G) Phenol-
                                                                             polymer for        formaldehyde
                                                                             coatings.          polymer with
                                                                                amino-oxirane
                                                                                copolymer and
                                                                                nitrobenzoates.
----------------------------------------------------------------------------------------------------------------
* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
  information and documents have been provided with the submission prior to the start of the 90 day review
  period, and in no way reflects the final status of a complete submission review.

    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
that have passed an initial screening 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 Approved * From 05/01/2022 to 05/31/2022
----------------------------------------------------------------------------------------------------------------
                                              Commencement    If amendment, type of
          Case No.            Received date       date              amendment            Chemical  substance
----------------------------------------------------------------------------------------------------------------
J-21-0020..................      05/18/2022      05/02/2022  N.....................  (G) Cinderbio-14057
                                                                                protease.
J-21-0021..................      05/18/2022      04/29/2022  N.....................  (G) Cinderbio-14624
                                                                                protease.
J-21-0022..................      05/18/2022      04/22/2022  N.....................  (G) Cinderbio-23726
                                                                                protease.
J-21-0023..................      05/18/2022      04/27/2022  N.....................  (G) Cinderbio-23117
                                                                                esterase/lipase.
J-21-0024..................      05/18/2022      04/15/2022  N.....................  (G) Cinderbio-13366
                                                                                cellulase/xylanase.
J-21-0025..................      05/18/2022      04/20/2022  N.....................  (G) Cinderbio-13184
                                                                                amylase.
P-04-0856A.................      05/11/2022      11/02/2016  Amended generic name..  (G) Long chain alkyl
                                                                                benzene sulfonic acids.
P-13-0289A.................      05/17/2022      06/13/2018  Amended generic name..  (G) Alkanoic acid,
                                                                                tetramethyl-sec amino-
                                                                                heteromonocyclic ester.
P-15-0017A.................      05/05/2022      06/16/2017  Amended generic name..  (G) Iron
                                                                                alkylenediaminehydroxyacet
                                                                                ate sulfophonic acid.
P-16-0514A.................      05/12/2022      01/16/2019  Amended generic name..  (G) Nickel, cobalt mixed
                                                                                metal oxide.
P-17-0332A.................      05/13/2022      11/20/2018  Amended generic name..  (G) Benzenesulfonic acid,
                                                                                2,2'-(1,2-
                                                                                ethenediyl)bis[[[(hydroxya
                                                                                lkyl)amino]-(arylamino)-
                                                                                triazinyl]amino]-, n-
                                                                                (hydroxyalkyl).
P-17-0354A.................      05/13/2022      02/04/2019  Withdrew CBI claim....  (S) 4-(fluorodimethylsilyl)-
                                                                                butanenitrile.
P-18-0160A.................      05/18/2022      02/12/2020  Amended generic name..  (G) Heteropolycyclic, halo
                                                                                substituted alkyl
                                                                                substituted- diaromatic
                                                                                amino substituted
                                                                                carbomonocycle, halo
                                                                                substituted alkyl
                                                                                substituted
                                                                                heteropolycyclic,
                                                                                tetraphenylborate (1:1).
P-19-0028A.................      05/11/2022      08/05/2021  Amended generic name..  (G) Alkyl salicylate,
                                                                                calcium salts.
P-20-0084..................      05/13/2022      04/14/2022  N.....................  (G) 2-propenoic acid, 2-
                                                                                methyl, 2-
                                                                                (dimethylamino)ethyl
                                                                                ester, polymers with 2-
                                                                                (c16-18-acylamino)ethyl
                                                                                acrylate and hydroxyalkyl
                                                                                acrylate, acetates
                                                                                (salts).
P-20-0172..................      05/11/2022      04/12/2022  N.....................  (G) Glycerin, alkoxylated
                                                                                alkyl acid esters.
P-21-0063A.................      05/11/2022      11/29/2021  Amended generic name..  (G) Pyrazole-polycarboxylic
                                                                                acid, polyhaloaryl-
                                                                                polyhydro-alkyl-polyalkyl
                                                                                ester.
P-21-0186A.................      05/11/2022      01/18/2022  Amended generic name..  (G) Glycerin, polyalkyl
                                                                                glycol ethers alkyl acid
                                                                                esters.
----------------------------------------------------------------------------------------------------------------
* The term `Approved' indicates that a submission has passed a quick initial screen ensuring all required
  information and documents have been provided with the submission.

    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 that has been received 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 05/01/2022 to 05/31/2022
------------------------------------------------------------------------
                                         Type of test        Chemical
       Case No.         Received date     information       substance
------------------------------------------------------------------------
P-14-0712............      05/16/2022  Polychlorinated   (S) Waste
                                        Dibenzodioxins    plastics,
                                        and               pyrolyzed, C5-
                                        Polychlorinated   55 fraction.
                                        Dibenzofurans
                                        Testing.
P-16-0462............      05/15/2022  Metals Analysis   (G) Ash
                                        for Quarter 1     (residues),
                                        and Quarter 2     reaction
                                        2022.             products with
                                                          tetraethoxydio
                                                          xa-
                                                          polyheteroatom-
                                                          disilaalkane.
P-16-0543............      05/10/2022  Exposure          (G)
                                        Monitoring        Halogenophosph
                                        Report.           oric acid
                                                          metal salt.
P-18-0016............      05/09/2022  Dissociation      (G) Aromatic
                                        Constant          sulfonium
                                        Determination     tricyclo
                                        Study.            fluoroalkyl
                                                          sulfonic acid
                                                          salt.
P-20-0042............      05/09/2022  Dissociation      (G) Sulfonium,
                                        Constant          trisaryl-, 7,7-
                                        Determination     dialkyl-2-
                                        Study.            heteropolycycl
                                                          ic -1-
                                                          alkanesulfonat
                                                          e (1:1).
P-20-0042............      05/09/2022  Dissociation      (G) Sulfonium,
                                        Constant          trisaryl-, 7,7-
                                        Determination     dialkyl-2-
                                        Study.            heteropolycycl
                                                          ic -1-
                                                          alkanesulfonic
                                                          acid (1:1).
P-21-0180............      05/09/2022  Dissociation      (G) Sulfonium,
                                        Constant          (halocarbomono
                                        Determination     cycle)diphenyl-
                                        Study.            , salt with 1-
                                                          heterosubstitu
                                                          ted-2-
                                                          methylalkyl
                                                          trihalobenzoat
                                                          e (1:1).
P-21-0180............      05/09/2022  Dissociation      (G) Sulfonium,
                                        Constant          (heterosubstit
                                        Determination     utedphenyl)dip
                                        Study.            henyl-, salt
                                                          with 1-
                                                          heterosubstitu
                                                          ted-2-
                                                          methylalkyl
                                                          trisubstituted
                                                          benzoate
                                                          (1:1).
P-22-0021............      05/18/2022  Acute Fish        (G)
                                        Testing; Ready    Alkylphosphoni
                                        Biodegradabilit   c acid,
                                        y Testing (OECD   calcium salt.
                                        Test Guideline
                                        301); Skin
                                        Sensitizaiton
                                        Testing (OECD
                                        Test Guideline
                                        406); Testing
                                        Summary
                                        Information; In
                                        Vitro Mammalian
                                        Chromosome
                                        Aberration
                                        Testing (OECD
                                        Test Guideline
                                        473); Mammalian
                                        Erythrocyte
                                        Micronucleus
                                        Testing (OECD
                                        Test Guideline
                                        474); Acute
                                        Oral Toxicity
                                        Testing (OECD
                                        Test Guideline
                                        401, 420, 423,
                                        425); Acute
                                        Dermal
                                        Irriation
                                        Testing (OECD
                                        Test Guideline
                                        404); Acute Eye
                                        Irritation
                                        Testing (OECD
                                        Test Guideline
                                        405).
------------------------------------------------------------------------

    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: June 15, 2022.
Pamela Myrick,
Director, Project Management and Operations Division, Office of
Pollution Prevention and Toxics.
[FR Doc. 2022-13779 Filed 6-27-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 118 (Wednesday, June 19, 2019)]
[Notices]
[Page 28549]
[FR Doc No: 2019-12968]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP18-1115-003.
    Applicants: Saltville Gas Storage Company L.L.C.
    Description: Compliance filing Saltville RP18-1115 Compliance
Filing--Fuel Reimbursement to be effective 7/1/2019.
    Filed Date: 6/10/19.
    Accession Number: 20190610-5073.
    Comments Due: 5 p.m. ET 6/24/19.

    Docket Numbers: RP19-1311-000.
    Applicants: Granite State Gas Transmission, Inc.
    Description: Compliance filing internet Compliance Filing to be
effective 8/1/2019.
    Filed Date: 6/11/19.
    Accession Number: 20190611-5124.
    Comments Due: 5 p.m. ET 6/24/19.

    Docket Numbers: RP19-1312-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Compliance filing 061219 Compliance Filing
Implementing Approved Settlement Rates to be effective 7/1/2019.
    Filed Date: 6/12/19.
    Accession Number: 20190612-5020.
    Comments Due: 5 p.m. ET 6/24/19.

    Docket Numbers: RP19-1313-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates Cleanup
Filing June 2019--various South Jersey to be effective 7/12/2019.
    Filed Date: 6/12/19.
    Accession Number: 20190612-5026.
    Comments Due: 5 p.m. ET 6/24/19.

    Docket Numbers: RP19-343-005.
    Applicants: Texas Eastern Transmission, LP.
    Description: Compliance filing TETLP Compliance Filing--RP19-343-
000 to be effective 1/1/2019.
    Filed Date: 6/12/19.
    Accession Number: 20190612-5102.
    Comments Due: 5 p.m. ET 6/24/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 13, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-12968 Filed 6-18-19; 8:45 am]
BILLING CODE 6717-01-P


Section H FQPA Supplemental Information for the Tolerance Petition A. Executive Summary Bayer CropScience is proposing to amend 40CFR 180.472 by requesting tolerances be established for oats and rye.

Analysis of imidacloprid and metabolites is by conversion to 6 chloronicotinic acid ( 6 CAN) and derivitization before injection onto a gas chromatograph equipped with mass selective detection. The limit of quantitation is 0.05 ppm. Aggregate exposure comes from seed treatment, in furrow, and foliar uses as veterinary uses.

B. Background Information and Profile Bayer CropScience is proposing to amend 40CFR 180.472 by establishing tolerances for residues of imidacloprid ( 1[( 6 chloro 3 pyridinyl) methyl] N nitro 2 imidazolidinimine) and its metabolites containing the 6 chloropyridinyl moiety, all expressed as 1[( 6 chloro 3 pyridinyl) methyl] N nitro 2 imidazolidinimine in or on the raw agricultural commodities:

Oats, grain 0.5ppm Oats, forage 2.0ppm Oats, hay 6.0ppm Oats, straw 3.0ppm Rye, grain 0.5ppm Rye, forage 2.0ppm Rye, hay 6.0ppm Rye, straw 3.0ppm The nature of the metabolic pathway in plants is adequately understood. The analytical method for determining residues is the conversion to 6 CAN and derivitization before injection onto a gas chromatograph equipped with mass selective detection. The limit of quantitation is 0.05 ppm. Imidacloprid is an excellent insecticide for providing early season protection of seedlings against injury by aphids and wireworm.

The Agency requested this tolerance submission to add oats and rye to the imidaclorid seed treatment labels as an alternative to other insecticides. The tolerances are based on existing tolerances for wheat and barley.

C. Toxicological Profile 1. Acute toxicity. The acute oral LD50 values for imidacloprid technical ranged from 424 milligrams/ kilograms ( mg/ kg) in the male rat and < 450 mg/ kg in the female rat. The acute dermal LD50 was < 5,000 mg/ kg in the rat. The 4 hour rat inhalation LC50 was < 5.33 mg/ L. Imidacloprid was not irritating to rabbit skin or eyes. Imidacloprid did not cause skin sensitization in guinea pigs. In an acute neurotoxicity study the lowest observed adverse effect level ( LOAEL) = 42 mg/ kg body weight day ( bwt/ day). 2. Genotoxicity. Mutagenicity studies have demonstrated that imidacloprid is non mutagenic both in vivo and in vitro. 3. Reproductive and developmental toxicity. In a developmental toxicity study with Sprague Dawley rats, groups of pregnant animals ( 25/ group) received oral administration of imidacloprid ( 94.2%) at 0, 10, 30, or 100 mg/ kg bwt/ day during gestation days 6 through 16. Maternal toxicity was manifested as decreased body weight gain at all dose levels and reduced food consumption a t 100 milligrams/ kilograms of body weight/ day ( mg/ kg bwt/ day). No treatment related effects were seen in any of the reproductive parameters ( i. e., Cesarean section evaluation). At 100 mg/ kg bwt/ day, developmental toxicity manifested as wavy ribs ( fetus   7/ 149 in treated vs. 2/ 158 in controls and litters, 4/ 25 vs. 1/ 25). For maternal toxicity, the LOAEL was 10 mg/ kg bwt/ day lowest dose tested ( LDT) based on decreased body weight gain; a NOAEL was not established. For developmental toxicity, the NOAEL was 30 mg/ kg bwt/ day and the LOAEL was 100 mg/ kg bwt/ day based on increased wavy ribs master record identification ( MRID No. 42256338). In a developmental toxicity study with Chinchilla rabbits, groups of 16 pregnant does were given oral doses of imidacloprid ( 94.2%) at 0, 8, 24, or 72 mg/ kg bwt/ day during gestation days 6 through 18. For maternal toxicity, the NOAEL was 24 mg/ kg bwt/ day and the LOAEL was 72 mg/ kg bwt/ day based on mortality, decreased body weight gain, increased resorptions, and increased abortions. For developmental toxicity, the NOAEL was 24 mg/ kg bwt/ day and the LOAEL was 2 mg/ kg bwt/ day based on decreased fetal body weight, increased resorptions, and increased skeletal abnormalities ( MRID No. 42256339). In a 2 generation reproductive toxicity study, imidacloprid ( 95.3%) was administered to Wistar/ Han rats at dietary levels of 0, 100, 250, or 700 ppm ( 0, 7.3, 18.3, or 52.0 mg/ kg bwt/ day for males and 0, 8.0, 20.5, or 57.4 mg/ kg bwt/ day for females) ( MRID No. 42256340, Doc. No. 010537). For parental/ systemic/ reproductive toxicity, the NOAEL was 250 ppm ( 18.3 mg/ kg bwt/ day) and the LOAEL was 750 ppm ( 52 mg/ kg bwt/ day), based on decreases in body weight in both sexes in both generations. Based on these factors, EPA recommended that the Data Evaluation Record should be revised to indicate the parental/ systemic/ reproductive NOAEL and LOAEL to be 250 and 700 ppm, respectively, based upon the body weight decrements observed in both sexes in both generations. 4. Subchronic toxicity. In a dermal toxicity study, groups of five male and five female New Zealand white rabbits received repeated dermal applications of imidacloprid ( 95%) at 1,000 mg/ kg bwt/ day ( LD), 6 hours/ day, 5 days/ week for 3 weeks. No dermal or systemic toxicity was seen. For systemic and dermal toxicity, the NOAEL was < 1,000 mg/ kg bwt/ day, a LOAEL was not established ( MRID No. 42256329). In an oral toxicity study, groups of Fischer 344 rats ( 12/ sex/ dose) were fed diets containing imidacloprid ( 98.8%) at 8, 150, 1,000, or 3,000 ppm ( 0, 9.3, 63.3, or 196 mg/ kg bwt/ day in males and 0, 10.5, 69.3, or 213 mg/ kg bwt/ day in females, respectively) for 90 days. No treatment related effects were seen at 150 ppm. Treatment related effects included decreases in body weight gain during the first 4 weeks of the study at 1,000 ppm ( 22% in males and 18% in females) and 3,000 ppm ( 50% in males and 25% in females) with an associated decrease in forelimb grip strength especially in males. The NOAEL was 150 ppm ( 9.3 and 10.5 mg/ kg bwt/ day in males and females, respectively) and the LOAEL was 1,000 ppm ( 63.3 and 69.3 mg/ kg bwt/ day in males and females, respectively) ( MRID No. 43286401). In a rat inhalation study ( 28 day study in which rats were exposed 6 hours/ day, 5 days/ week for 4 weeks), the NOAEL for imidacloprid was 5.5 mg/ m3 ( MRID No. 422730 01). 5. Chronic toxicity. In a chronic toxicity study, groups of beagle dogs ( 4/ sex/ dose) were fed diets containing imidacloprid ( 94.9%) at 0, 200 or 1,250/ 2,500 ppm ( 0, 6.1, 15 or 41/ 72 mg/ kg bwt/ day, respectively) for 52 weeks. The 1,250 ppm dose was increased to 2,500 ppm from week 17 onwards. The threshold NOAEL was 1,250 ppm ( 41 mg/ kg bwt/ day). The LOAEL was 2,500 ppm ( 72 mg/ kg bwt/ day) based on increased cytochrome P 450 levels in both sexes and was considered to be a threshold dose. Due to the lack of toxicity at 1,250 ppm, a LOAEL was not established in this study following the dose increase to the 2,500 ppm level, toxicity was observed, thus making 1,250 ppm the threshold NOAEL and 2,500 ppm the threshold LOAEL ( MRID No. 42273002). 6. Animal metabolism. The metabolism imidacloprid in rats was reported in seven studies. These data show that imidacloprid was rapidly absorbed and eliminated in the excreta ( 90% of the dose within 24 hours), demonstrating no biologically significant differences between sexes, dose levels, or route of administration. Elimination was mainly renal ( 70 80% of the dose) and fecal ( 17 25%). The major part of the fecal activity originated in the bile. Total Body accumulation after 48 hours consisted of 0.5% of the radio activity with the liver, kidney, lung, skin and plasma being the major sites of accumulation. Therefore, bioaccumulation of imidacloprid is low in rats. Maximum plasma concentration was reached between 1.1 and 2.5 hours. Two major routs of biotransformation were proposed for imidacloprid. The first route included an oxidative cleavage of the parent compound rendering 6 chloronicotinic acid and its glycine conjugate. Dechlorination of this metabolite formed the 6 hydroxynicotinic acid and its mercapturic acid derivative. The second route included the hydroxylation followed by elimination of water of the parent compound rendering imidacloprid. A comparison between [ methylene 14C] imidacloprid and [ imidazolidine 4,5 14C] imidacloprid showed that while the rate of excretion was similar, the renal portion was higher with the imidazolidine labeled compound. In addition, accumulation in tissues was generally higher with the imidazolidine labeled compound. A comparison between imidacloprid and one of its metabolites. WAK 3839 showed that the total elimination was the same for both compounds. The proposed metabolic pathways for these two compounds were different. WAK 3839 was formed following pretreatment ( repeated dosing) of imidacloprid. 7. Endocrine disruption. The toxicology data base for imidacloprid is current and complete. Studies in this data base include evaluation of the potential effects on reproduction and development effects on reproduction and development, and an evaluation of the pathology of the endocrine organs following short term or long term exposure. These studies revealed no primary endocrine effects due to imidacloprid.

A. Aggregate Exposure Dietary Exposure. Dietary exposure for oats and rye has been previously accounted for in rotational crop inadvertent tolerances for imidacloprid on cereal grain, group 15 and forage, hay, and straw. So no additional dietary burden is expected.

i. Food. Acute and chronic risk assessments will not be different from the current risk assessments since there is no increase in exposure for earlier assessments containing the rotational crop inadvertent tolerances for cereal grains.

ii. Drinking water. EPA, as published in the Federal Register of April 10, 2001 ( 66 FR 18554) ( FRL 6777 6), calculated acute and chronic DWLOCs and compared them with the EECs for surface and ground water. Based on this comparison, they determined that acute exposure and chronic exposure would not be expected to exceed the aPAD and cPAD, respectively.

1. Non dietary exposure  i. Residential turf. Bayer CropScience has conducted an exposure study to address the potential exposures of adults and children from contact with imidacloprid treated turf. The population considered to have the greatest potential exposure from contact with pesticide treated turf soon after pesticides are applied are young children. Margins of safety ( MOS) of 7,587   41,546 for 10 year old children and 6,859   45,249 for 5 year old children were estimated by comparing dermal exposure doses to the imidacloprid NOAEL of 1,000 mg/ kg/ day established in a 15 day dermal toxicity study in rabbits. The estimated safe residue levels of imidacloprid on treated turf for 10 year old children ranged from 5.6   38.2 µ g/ cm2 and for 5 year old children from 5.1   33.5 µ g/ cm2. This compares with the average imidacloprid transferable residue level of 0.080 µ g/ cm2 present immediately after the sprays have dried. These data indicate that children can safely contact imidaclopridtreated turn as soon after application as the spray has dried. ii. Termiticide. Imidacloprid is registered as a termiticide. Due to the nature of the treatment for termites, exposure would be limited to that from inhalation and was evaluated by EPA and Bayer CropScience. Data indicate that the MOS for the worst case exposures for adults and infants occupying a treated building who are exposed continuously ( 24 hours/ day) are 8.0 x 10 7 and 2.4 x 10 8, respectively   and exposure can thus be considered negligible. iii. Tobacco. Smoke Studies have been conducted to determine residues in tobacco and the resulting smoke following treatment. Residues of imidacloprid in cured tobacco following treatment were a maximum of 31 ppm ( 7 ppm in fresh leaves). When this tobacco was turned in a pyrolysis study only 2% of the initial residue was recovered in the resulting smoke ( main stream plus side stream). This would result in an inhalation exposure to imidacloprid from smoking of approximately 0.005 mg per cigarette. Using the measured subacute rat inhalation NOAEL of 5.5 mg/ m3, it is apparent that exposure to imidacloprid from smoking ( direct and/ or indirect exposure) would not be significant. iv. Pet treatment. Human exposure from the use of imidacloprid to treat dogs and cats for fleas has been addressed by EPA with the conclusion that due to the fact that imidacloprid is not an inhalation or dermal toxicant and that while dermal absorption data are not available, imidacloprid is not considered to present a hazard via the dermal route.

A. Cumulative Effects Imidacloprid is a chloronicotinyl insecticide. At this time, EPA has not made a determination that imidacloprid and other substances that may have a common mechanism of toxicity would have cumulative effects. Therefore, for these tolerance petitions, it is assumed that imidacloprid does not have a common mechanism of toxicity with other substances and only the potential risks of imidacloprid in its aggregate exposure are considered.

B. Safety Determination 1. U. S. population. EPA has considered data from developmental toxicity studies in the rat and rabbit and a 2 generation reproduction study in the rat. These studies are discussed under section A ( Toxicology Profile) above. The developmental toxicity data demonstrated no increased sensitivity of rats or rabbits to in utero exposure to imidacloprid. In addition, the multigeneration reproductive toxicity study did not identify any increased sensitivity of rats to in utero or post natal exposure. Parental NOAELs were lower or equivalent to developmental or offspring NOAELs. The developmental toxicity studies are designed to evaluate adverse effects on the developing organism resulting from maternal pesticide exposure during gestation. Reproduction studies provide information relating to effects from exposure to the pesticide on the reproductive capability of mating animals and data on systemic toxicity.

FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA determines that a different MOS will be safe for infants and children. MOS are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty ( safety) factors ( UF) in calculating a dose level that poses no appreciable risk to humans. EPA believes that reliable data support using the standard UF ( usually 100 for combined inter species and intra species variability) and not the additional tenfold MOE/ UF when EPA has a complete data base under existing guidelines and when the severity of the effect in infants or children or the potency or unusual toxic properties of a compound do not raise concerns regarding the adequacy of the standard MOE/ UF.

Although developmental toxicity studies showed no increased sensitivity in fetuses as compared to maternal animals following in utero exposures in rates and rabbits, no increased sensitivity in pups as compared to adults was seen in the 2 generation reproduction toxicity study in rats, and the toxicology data base is complete as to core requirements, EPA has determined that the additional safety factor for the protection of infants and children will be retained but reduced to 3x based on the following weight of the evidence considerations relating to potential sensitivity and completeness of the data:

i. There is concern for structure activity relationship. Imidacloprid, a chloronicotinyl compound, is an analog to nicotine and studies in the published literature suggests that nicotine, when administered caused developmental toxicity, including functional deficits, in animals and / or humans that are exposed in utero. ii. There is evidence that imidacloprid administration causes neurotoxicity following a single oral dose in the acute study and alterations in brain weight in rat in the 2 year carcinogenicity study. iii. The concern for structure activity relationship along with the evidence of neurotoxicity dictates the need of a developmental neurotoxicity study for assessment of potential alterations on functional development. Because a developmental neurotoxicity study potentially relates to both acute and chronic effects in both the mother and fetus, EPA has applied the additional UF for FQPA for all population subgroups, and in both acute and chronic risk assessments. Based on the exposure assessments described above and on the completeness and reliability of the toxicity data, it can be concluded that the dietary exposure estimates from all label and pending uses of imidacloprid are 9.4% of the aPAD at the 99.9th percentile and 1.2% of the cPAD for the U. S. population. Thus, it can be concluded that there is reasonable certainty that no harm will result from aggregate exposure to imidacloprid residues.

1. Infants and children. Based on the exposure assessments described above for the safety determination of the U. S. population and on the completeness and reliability of the toxicity data, it can be concluded that the dietary exposure estimates from all label and pending uses of imidacloprid are 27.1% of the aPAD at the 99.9th percentile and 2.6% of the cPAD for the most sensitive population subgroup, children 1 2 years. Thus, it can be concluded that there is a reasonable certainty that no harm will result from aggregate exposure to imidacloprid residues.

A. International Tolerances No CODEX Maximum Residue Levels have been established for residues of imidacloprid on oats or rye.