[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Notices]
[Pages 9848-9849]
[FR Doc No: 2016-04184]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9025-7]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www2.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EISs)
Filed 02/15/2016 Through 02/19/2016
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-nepa-public/action/eis/search.

EIS No. 20160041, Final, FTA, NC, Durham-Orange Light Rail, Contact:
Stanley A. Mitchell<PHONE_NUMBER>, Under MAP 21 section 1319, FTA has
issued a Final EIS and ROD. Therefore, the 30-day wait/review period
under NEPA does not apply to this action.
EIS No. 20160042, Final, USACE, CA, San Elijo Lagoon Restoration
Project, Review Period Ends: 03/28/2016, Contact: Meris Guerrero 760-
602-4836
EIS No. 20160043, Draft Supplement, USFWS, OH, Ballville Dam Project,
Comment Period Ends: 04/11/2016, Contact: Brian Elkington<PHONE_NUMBER>
EIS No. 20160044, Draft Supplement, BOEM, LA, Gulf of Mexico OCS Oil
and Gas Lease Sale: 2017 Central Planning Area Lease Sale 247, Comment
Period Ends: 04/11/2016, Contact: Gary Goeke<PHONE_NUMBER>
EIS No. 20160045, Final, TVA, TN, Floating Houses Policy Review, Review
Period Ends: 03/28/2016, Contact: Matthew Higdon<PHONE_NUMBER>
EIS No. 20160046, Draft, FERC, OH, Rover Pipeline, Panhandle Backhaul,

and Trunkline Backhaul Projects, Comment Period Ends: 04/11/2016,
Contact: Kevin Bowman<PHONE_NUMBER>

    Dated: February 23, 2016.
Dawn Roberts,
Management Analyst, NEPA Compliance Division, Office of Federal
Activities.
[FR Doc. 2016-04184 Filed 2-25-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4213-4214]
[FR Doc No: 2018-01642]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-2521]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ZEPATIER

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for ZEPATIER and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
2, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by July 30, 2018. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 2, 2018. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-E-2521 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; ZEPATIER.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product ZEPATIER
(grazoprevir; elbasvir). ZEPATIER is indicated with or without
ribavirin for treatment of chronic hepatitis C virus genotypes 1 or 4
infection in adults. Subsequent to this approval, the USPTO received a
patent term restoration application for ZEPATIER (U.S. Patent No.
7,973,040) from Merck Sharp & Dohme Corp. and MSD Italia s.r.l., and
the USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated November 10,
2016, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of ZEPATIER
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ZEPATIER is 1,865 days. Of this time, 1,619 days occurred during the
testing phase of the regulatory review period, while 246 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
December 22, 2010. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
December 22, 2010.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: May 28,
2015. FDA has verified the applicant's claim that the new drug
application (NDA) for ZEPATIER (NDA 208-261) was initially submitted on
May 28, 2015.
    3. The date the application was approved: January 28, 2016. FDA has
verified the applicant's claim that NDA 208-261 was approved on January
28, 2016.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 188 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01642 Filed 1-29-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 148 (Thursday, August 1, 2019)]
[Rules and Regulations]
[Pages 37570-37573]
[FR Doc No: 2019-16329]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0567; Product Identifier 2019-NE-21-AD; Amendment
39-19698; AD 2019-15-05]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce Deutschland Ltd & Co KG
Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Rolls-Royce Deutschland Ltd & Co KG (RRD) Trent 1000-AE3, Trent 1000-
CE3, Trent 1000-D3, Trent 1000-G3, Trent 1000-H3, Trent 1000-J3, Trent
1000-K3, Trent 1000-L3, Trent 1000-M3, Trent 1000-N3, Trent 1000-P3,
Trent 1000-Q3 and Trent 1000-R3 engines. This AD requires removal of
the affected high-pressure turbine (HPT) disk front cover plate before
reaching its new life limit. This AD was prompted by a recent analysis
that determined the HPT disk front cover plate may have a safe life
below its declared life limit. The FAA is issuing this AD to address
the unsafe condition on these products.

DATES: This AD is effective August 16, 2019.
    The FAA must receive comments on this AD by September 16, 2019.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this final rule, contact
Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby, United
Kingdom, DE24 8BJ; phone: 011-44-1332-242424; fax: 011-44-1332-249936;
exception occurred on : 2019-16329.htm
exception occurred on : 2019-16329.htm
email: royce.com">[email protected]royce.com; internet: https://customers.rolls-royce.com/public/rollsroycecare. You may view this
service information at the FAA, Engine and Propeller Standards Branch,
1200 District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2019-0567.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0567; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the mandatory continuing airworthiness information
(MCAI), the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations is listed above.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Besian Luga, Aerospace Engineer, ECO
Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-
238-7750; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Community, has
issued EASA AD 2018-0164R1, dated March 14, 2019 (corrected copy dated
March 21, 2019) (referred to after this as ``the MCAI''), to address an
unsafe condition for the specified products. The MCAI states:

    Following a recent analysis of the material condition used in
manufacture of these parts, it was established that the HP turbine
disc front cover plate may have a safe life below its declared safe
cyclic life (DSCL).
    This condition, if not corrected, could lead to premature
failure of an affected part, possibly resulting in damage to the
engine and reduced control of the aeroplane.
    To address this potential unsafe condition, RR published the
NMSB to provide the new DSCL and replacement instructions.
Consequently, EASA issued AD 2018-0164 to require implementation of
the reduced DSCL and removal from service of those affected parts
that have exceeded the reduced DSCL.
    Since that [EASA] AD was issued, further analysis has resulted
in the approval of an extended life for the affected parts. RR has
published the TLM Task for this extended limit and it is expected
the NMSB will be cancelled accordingly.

    You may obtain further information by examining the MCAI in the AD
docket on the internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2019-0567.

Related Service Information

    The FAA reviewed Rolls-Royce plc (RR) Alert Service Bulletin (ASB)
TRENT1000 72-AK057, Initial Issue, dated April 10, 2018. The service
information describes procedures for either removing the engine
containing the affected HPT disk front cover plate or replacing the HPT
disk front cover plate during a shop visit.

FAA's Determination

    This product has been approved by EASA and is approved for
operation in the United States. Pursuant to our bilateral agreement
with the European Community, EASA has notified us of the unsafe
condition described in the MCAI and service information referenced
above. The FAA is issuing this AD because we evaluated all the relevant
information provided by EASA and determined the unsafe condition
described previously is likely to exist or develop in other products of
the same type design.

AD Requirements

    This AD requires removal of the affected HPT disk front cover plate
from service before reaching its new life limit and replacing it with a
part eligible for installation.

Differences Between This AD and the MCAI or Service Information

    This AD and EASA AD 2018-0164R1, dated March 14, 2019 (corrected
copy dated March 21, 2019) require removal of the affected HPT disk
front cover plate before accumulating 1,250 cycles since first
installation on an engine. RR ASB Trent1000 72-AK057, Initial Issue,
dated April 10, 2018, requires removal of the affected HPT disk front
cover plate before accumulating 865 cycles since first installation.
Since publication of the ASB, the manufacturer has revised its
analysis, which has resulted in an extension of the life limit for this
part to 1,250 cycles.

FAA's Justification and Determination of the Effective Date

    No domestic operators use this product. Therefore, the FAA finds
good cause that notice and opportunity for prior public comment are
unnecessary. In addition, for the reason stated above, the FAA finds
that good cause exists for making this amendment effective in less than
30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, the FAA invites you to send any written data, views,
or arguments about this final rule. Send your comments to an address
listed under the ADDRESSES section. Include the docket number FAA-2019-
0567 and Product Identifier 2019-NE-21-AD at the beginning of your
comments. The FAA specifically invites comments on the overall
regulatory, economic, environmental, and energy aspects of this final
rule. The FAA will consider all comments received by the closing date
and may amend this final rule because of those comments.
    The FAA will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. The FAA will also post a report summarizing each substantive
verbal contact we receive about this final rule.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because the FAA has determined
that it has good cause to adopt this rule without notice and comment,
RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 0 engines installed on
airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Replace HPT disk front cover plate....  7 work-hours x $85 per          $307,137        $307,732              $0
                                         hour = $595.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to engines, propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2019-15-05 Rolls-Royce Deutschland Ltd & Co KG: Amendment 39-19698;
Docket No. FAA-2019-0567; Product Identifier 2019-NE-21-AD.

(a) Effective Date

    This AD is effective August 16, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Rolls-Royce Deutschland Ltd & Co KG (RRD)
Trent 1000-AE3, Trent 1000-CE3, Trent 1000-D3, Trent 1000-G3, Trent
1000-H3, Trent 1000-J3, Trent 1000-K3, Trent 1000-L3, Trent 1000-M3,
Trent 1000-N3, Trent 1000-P3, Trent 1000-Q3 and Trent 1000-R3
engines.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7250, Turbine
Section.

(e) Unsafe Condition

    This AD was prompted by recent analysis of the material
condition used in the manufacture of these parts that determined the
high-pressure turbine (HPT) disk front cover plate may have a safe
life below its declared safe cyclic life. The FAA is issuing this AD
to prevent failure of the HPT disk front cover plate. The unsafe
condition, if not addressed, could result in uncontained release of
the HPT turbine disk front cover plate, damage to the engine, and
damage to the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Remove the HPT disk front cover plate, part number KH59279, from
service prior to it reaching 1,250 engine cycles since first
installation on an engine and replace with a part eligible for
installation.

(h) Installation Prohibition

    Do not install any HPT disk front cover plate, part number
KH59279, into any engine, or any engine onto any airplane, if that
part has exceeded 1,250 engine cycles since first installation on an
engine.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in paragraph (j) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    (1) For more information about this AD, contact Besian Luga,
Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to European Union Aviation Safety Agency (EASA) AD
2018-0164R1, dated March 14, 2019 (corrected copy dated March 21,
2019), for more information. You may examine the EASA AD in the AD
docket on the internet at http://www.regulations.gov by searching
for and locating it in Docket No. FAA-2019-0567.

(k) Material Incorporated by Reference

    None.

    Issued in Burlington, Massachusetts, on July 26, 2019.
Karen M. Grant,
Acting Manager, Engine and Propeller Standards Branch, Aircraft
Certification Service.
[FR Doc. 2019-16329 Filed 7-31-19; 8:45 am]
 BILLING CODE 4910-13-P


1 EPA Registration Division contact: Dani Daniel, 703 305 5409 Barbara Madden, 703 305 6463 Syngenta Crop Protection Inc. and Interregional Research Project # 4 ( IR 4)

PP# 6E7060, 0F6142 and 9F5051 EPA has received pesticide petitions ( PP# 9F5051 and 0F6142) from Syngenta Crop Protection Inc., P. O. Box 18300, Greensboro, NC 27419 8300 and pesticide petition ( PP# 6E7060) from Interregional Research Project # 4 ( IR 4), 681 US Highway # 1 South, North Brunswick, NJ 08902 3390 , proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180.565 by establishing a tolerance for residues of thiamethoxam [ 3[( 2 chloro 5 thiazolyl) methyl] tetrahydro 5 methyl Nnitro 4H 1,3,5 oxadiazin 4 imine] ( CAS Reg. No. 153719 23 4) and its metabolite [ N( 2 chlorothiazol 5 ylmethyl) N' methyl  N' nitro guanidine] in or on the raw agricultural commodities: grapes at 0.15 parts per million ( ppm) ( 0F6142); grape juice at 0.20 ppm ( 0F6142) and raisins at 0.30 ppm ( 0F6142); vegetable, leafy, except brassica, group 4 at 2.0 ppm ( 9F5051); brassica, leafy greens, subgroup 5B at 2.0 ppm ( 9F5051); brassica, head and stem, subgroup 5A at 1.0 ppm ( 9F5051); caneberry subgroup 13A at 0.30 ppm ( 6E7060); hops at 0.1 ppm ( 6E7060); Globe artichoke at 0.4 ppm ( 6E7060) and tolerance increases for barley, grain at 0.3 ppm ( 6E7060); barley, hay at 0.4 ppm ( 6E7060); and barley, straw at 0.4 ppm ( 6E7060). EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry 1. Plant metabolism. [ The primary metabolic pathways of thiamethoxam in plants ( corn, cucumbers, lettuce, rice, and pears) were similar to those described for animals, with certain extensions of the pathway in plants. Parent compound and CGA 322704 were the major residues in all crops. The metabolism of thiamethoxam in plants and animals is understood for the purposes of the proposed tolerances. Parent thiamethoxam and the metabolite, CGA 322704, are the residues of concern for tolerance setting purposes.]

2. Analytical method. [ Syngenta Crop Protection Inc. has submitted practical analytical methodology for detecting and measuring levels of thiamethoxam in or on raw agricultural commodities. The method is based on crop specific cleanup procedures and determination by liquid chromatography with either UV or MS detection. The limit of detection ( LOD) for each analyte of this method is 1.25 ng injected for samples analyzed by UV and 0.25 ng injected for 2 samples analyzed by MS, and the limit of quantitation ( LOQ) is 0.005 ppm for milk and juices and 0.01 ppm for all other substrates. ]

3. Magnitude of residues. [ IR 4 has submitted complete residue data for thiamethoxam on hops, caneberries, globe artichokes and barley.

Syngenta has submitted complete residue data for the proposed tolerances on leafy vegetables, head and stem brassica vegetables, leafy brassica vegetables and grape commodities.]

B. Toxicological Profile 1. Acute toxicity. [ The acute oral LD50 for thiamethoxam in the rat is 1563 mg/ kg body weight. The acute dermal LD50 of thiamethoxam is > 2000 mg/ kg body weight. Thiamethoxam is non toxic at atmospheric concentrations of 3.72 mg/ l. Thiamethoxam is minimally irritating to the eye, non irritating to skin and is not a dermal sensitizer.

In an acute neurotoxicity screening study in rats ( OPPTS 870.6200a), the NOAEL was 100 mg/ kg/ day with a NOAEL of 500 mg/ kg/ day based on drooped palpebral closure, decrease in rectal temperature and locomotor activity and increase in forelimb grip strength ( males only). At higher dose levels, mortality, abnormal body tone, ptosis, impaired respiration, tremors, longer latency to first step in the open field, crouched over posture, gait impairment, hypo arousal, decreased number of rears, uncoordinated landing during the righting reflex test, slight lacrimation ( females only) and higher mean average input stimulus value in the auditory startle response test ( males only).]

2. Genotoxicty. [ In gene mutation studies with S. typhimurium and E. coli ( OPPTS 870.5100 and 870.5265), there was no evidence of gene mutation when tested up to 5000 ug/ plate and there was no evidence of cytotoxicity.

In a gene mutation study with chinese hamster V79 cells at the HGPRT locus ( OPPTS 870.5300) there was no evidence of of gene mutation when tested up to the solubility limit.

In a CHO cell cytogenetics study ( OPPTS 870.5375) there was no evidence of chromosomal aberrations when tested up to cytotoxic or solubility limit concentrations.

An in vivo mouse bone marrow micronucleus study ( OPPTS 870.5395) was negative for clastogenic effects when tested up to levels that induced significant toxicity in whole animals; There was no evidence of target cell cytotoxicity. 3 A unscheduled DNA synthesis ( UDS) assay ( OPPTS 870.5550) was negative when tested up to precipitating concentrations.]

3. Reproductive and developmental toxicity. [ A prenatal developmental study in the rat ( OPPTS 870.3700a) resulted in Maternal and Developmental NOAELs of 30 mg/ kg/ day and 200 mg/ kg/ day, respectively. The maternal LOAEL is 200 mg/ kg/ day based on decreased body weight, body weight gain and food consumption. The developmental LOAEL was 750 mg/ kg/ day based on decreased fetal body weight and an increased incidence of skeletal anomalies. There was no evidence of any teratogenic effects.

A prenatal developmental study in the rabbit ( OPPTS 870.3700b) resulted in maternal and developmental NOAELs of 50 mg/ kg/ day. The maternal and developmental LOAEL is 150 mg/ kg/ day. The maternal LOAEL is based on maternal deaths, hemorrhagic discharge, decreased body weight and food intake during the dosing period. The developmental LOAEL is based on decreased fetal body weights, increased incidence of post implantation loss and a slight increase in the incidence of a few skeletal anomolies/ variations. There was no evidence of any teratogenic effects related to treatment.

A 2 generation reproduction study in rats was conducted according to the most current EPA guidelines ( OPPTS 870.3800) at dose levels of 0, 20, 50, 1000 and 2500 ppm. An older 2 generation reproduction study in hte same strain of rats was conducted at dose levels of 0, 10, 30, 1000 and 2500 ppm. There were no effects on reproductive performance in either study. Considering both studies together, the NOAEL for parental/ systemic effects was 50 ppm ( 3.0 mg/ kg/ day) in males and 2500 ppm ( 208.8 mg/ kg/ day) in females, based upon kidney histopathology in males only at 1000 ppm ( 74.8 mg/ kg/ day). The overall NOAEL for reproductive effects was 2500 ppm, equivalent to 155.6 mg/ kg/ day in males and 208.8 mg/ kg/ day in females. For offspring toxicity, the NOAEL was 1000 pmm ( 74.8 mg/ kg/ day in males and 110.1 mg/ kg/ day in females), based on lower body weight gain during late lactation at 2500 ppm.]

4. Subchronic toxicity. [ A 90 day oral toxicity study in rats ( OPPTS 870.3100) resulted in NOAEL values of 1.74 ( males), 92.5 ( females) mg/ kg/ day. The LOAEL values were 17.64 ( male), 182.1 ( female) mg/ kg/ day based on increased incidence of hyaline change of renal tubules epithelium ( males), fatty change in adrenal gland of females and liver changes in females, all at the LOAEL.

A 90 day oral toxicity study in mice ( OPPTS 870.3100) resulted in NOAEL values of 1.41 ( males), 19.2 ( females) mg/ kg/ day. The LOAEL values were 14.3 ( male), 231 ( female) mg/ kg/ day based on increased incidence of hepatocellular hypertrophy. At higher dose levels: decrease in body weight and body weight gain, necrosis of individual hepatocytes, pigmentation of Kupffer cells, and lymphocytic infiltration of the liver in both sexes; slight hematologic effects and decreased absolute and relative kidney weights in males; and ovarian atrophy, decreased ovary and spleen weights and increased liver weights in females. 4 In a 90 day oral toxicity study in dogs ( OPPTS 870.3150), the NOAEL is 8.23 ( males), 9.27 ( females) mg/ kg/ day. The LOAEL is 32.0 ( male), 33.9 ( female) mg/ kg/ day based on slightly prolongeed prothrombin times and decreased plasma albumin and A/ G ratio ( both sexes); decreased calcium levels and ovary weights and delayed maturation in the ovaries ( female); decreased cholesterol and phospholipid levels, testis weights, spermatogenesis, and increased spermatic giant cells in testes ( male).

In a 28 day dermal study in rats ( OPPTS 870.3200) the NOAEL was 250 ( male), 60 ( female) mg/ kg/ day. The LOAEL was 1000 ( male), 250 ( female) mg/ kg/ day based on increased plasma glucose, triglyceride levels, and alkaline phosphatase activity and inflammatory cell infiltration in the liver and necrosis of single hepatocytes in females and hyaline change in renal tubules and a very slight reduction in body weight in males. At higher dose levels in females, chronic tubular lesions in the kidneys and inflammatory cell infiltration in the adrenal cortex were observed.

In a subchronic neurotoxicity screening study in rats ( OPPTS 870.6200b) the NOAEL was 95.4 ( male), 216.4 ( female) mg/ kg/ day, both at highest dose tested. There were no treatment related systemic effects, neurotoxicity signs, or histopathology findings in the central or peripheral nervous system. A LOAEL for neurotoxicological and systemic effects was not established.

In a developmental neurotoxicity ( DNT) study, a dietary level of 4000 ppm resulted in clear maternal toxicity, with lower bodyweights and food consumption, and lower pup bodyweights at birth. There was no effect on the development of F1 animals as assessed by the functional observation battery, locomotor activity, auditory startle response, or performance in learning and memory tests. No neuropathological effects of treatment were observed. The NOAEL for developmental toxicity was 4000 ppm, the highest dose tested ( equivalent to 298.7  593.5 mg/ kg/ day for maternal females during gestation and post partum, respectively).]

5. Chronic toxicity. [ In a chronic toxicity study in dogs ( OPPTS 870.4100) the NOAEL was 4.05 ( male), 4.49 ( female) mg/ kg/ day. The LOAEL was 21.0 ( male), 24.6 ( female) mg/ kg/ day based on increase of creatinine in both sexes, transient decrease in food consumption in females, and occasional increase in urea levels, decrease in ALT, and a slight increase in atrophy of seminiferous tubules in males.

In a mouse carcinogenicity study ( OPPTS 870.4200) the NOAEL was 2.63 ( male), 3.68 ( female) mg/ kg/ day. The LOAEL was 63.8 ( male), 87.6 ( female) mg/ kg/ day based on hepatocyte hypertrophy, single cell necrosis, inflammatory cell infiltration, pigment deposition, foci of cellular alteration, hyperplasia of Kupffer cells and increased mitotic activity, also an increase in the incidence of hepatocellular adenoma ( both sexes). At higher doses, there was an increase in the incidence of hepatocelluar adenocarcinoma ( both sexes) and the number of animals with multiple tumors, evidence of carcinogenicity in the liver. Investigative work demonstrated that the formation of liver tumors is specific to the mouse and arises due to a non genotoxic mode of action. The combination of factors leading to the development of liver tumors in mice do not 5 occur in humans. Therefore, humans are not at risk of developing liver tumors due to exposure to thiamethoxam.

In a combined chronic caricinogenicity study in rats ( OPPTS 870.4300) the NOAEL was 21.0 ( male), 50.3 ( female) mg/ kg/ day. The LOAEL was 63.0 ( male), 255 ( female) mg/ kg/ day based on increased incidence of lymphocytic infiltration of the renal pelvis and chronic nephropathy in males and decreased body weight gain, slight increase in the severity of hemosiderosis of the spleen, foci of cellular alteration in liver and chronic tubular lesions in kidney in females. No evidence of carcinogenicity. Investigative work demonstrated that effects in the kidneys of male rats, in subchronic as well as chronic studies, were secondary to treatment related increase in alpha 2u globulin associated kidney injury is unique to the male rat. Therefore, these kidney findings in the male rat are of no relevance to human risk assessment.]

6. Animal metabolism. [ The metabolism of thiamethoxam in rats and livestock animals is adequately understood. The residues of concern have been determined to be parent thiamethoxam and its metabolite ( N( 2 chloro thiazol 5 ylmethyl) N'methyl N" nitro guanidine.]

7. Metabolite toxicology. [ For most risk assessment purposes, residues of the metabolite corrected for molecular weight are considered to be toxicologically equivalent to parent thiamethoxam.]

8. Endocrine disruption. [ There is no indication from the mammalian toxicology database for any endocrine disrupting effect of thaimethoxam]

C. Aggregate Exposure 1. Dietary exposure. Tier I acute, chronic and short term aggregate risk assessments were made for thiamethoxam using the Dietary Exposure Evaluation Model ( DEEM FCIDTM , version 2.03) from Exponent. In addition to established tolerances ( 40CFR180.565) for the combined residues of thiamethoxam , 3[( 2 chloro 5 thiazolyl) methyl] tetrahydro 5 methyl N nitro 4H 1,3,5 oxadiazin 4 imine] and it's metabolite [ N( 2 chloro thiazol 5 ylmethyl) N' methyl N' nitroguanidine in or on a variety of raw agricultural commodities including meat and milk, these exposure assessments included all pending and proposed crop uses and a proposed use in turf ( including residential turf). Pending tolerances include grapes ( 0.05 ppm), grape raisins ( 0.30 ppm), grape juice ( 0.20 ppm), Brassica head and stem vegetables ( 1.0 ppm), leafy Brassica vegetables ( 2.0 ppm) and leafy vegetables ( 2.0 ppm). Proposed crop tolerances include hops ( 0.1 ppm), caneberries ( 0.3 ppm), globe artichoke ( 0.4 ppm), barley grain ( 0.3 ppm), barley straw ( 0.4 ppm) and barley hay ( 0.4 ppm). Percent crop treated values were conservatively estimated to be 6 100% for all established, pending and proposed uses. Drinking water estimates were incorporated directly into the dietary exposure assessments using the highest estimated drinking water concentrations ( EDWCs) for surface and ground water. All consumption data for these assessments was taken from the USDA's Continuing Survey of Food Intake by individuals ( CSFII) with the 1994 96 consumption database and the Supplemental CSFII children's survey ( 1998) consumption database.

In the tier II chronic assessment, the residue of concern was the sum of CGA 293343 and CGA 322704. Addition of the proposed crops mentioned above to the animal diets did not increase the previously calculated dietary burdens for any livestock commodities. Therefore, the residue values for secondary animal commodities were taken from the EPA assessment of August 28, 2000 which uses average field trial residue data with ½ LOQ substitutions for all non detectable residues. For the remaining registered and the proposed commodities listed above, the following residue data was used in the DEEMTM: cucurbit, leafy and Brassica vegetables and tomatoes  average field trial residues from soil only ( Platinum) application residue studies; stone fruits, mint, succulent beans, sunflower seed, and coffee  average field trial residue data with ½ LOQ substitutions for non detectable residues; all other commodities  the proposed tolerances listed in the acute section above.

i. Food. Acute Exposure The thiamethoxam acute dietary ( food only) risk assessment was performed on all population subgroups using an acute reference dose ( aRfD) of 1.0 mg/ kg bw/ day based upon an acute neurotoxicity study in rats with a no observable effect level ( NOAEL) of 100 mg/ kg/ day and an uncertainly factor of 100X. No additional FQPA safety factor was applied. For the purpose of aggregate risk assessment, the exposure value was expressed in terms of margin of exposure ( MOE). The MOE was calculated by dividing the no observable adverse effect level ( NOAEL) by the exposure for each population subgroup. In addition, exposure was expressed as a percent of the acute reference dose (% aRfD). At the 95th percentile of exposure, acute ( food only) exposure to the U. S. population resulted in an MOE of 13,205 ( 0.76% of the aRfD of 1.0 mg/ kg bw/ day. The most exposed sub population was children ( 1 2 years old) with an MOE of 5,615 ( 1.78% of the aRfD. Since the benchmark MOE for this assessment was 100 and since EPA generally has no concern for exposures below 100% of the acute RfD, Syngenta believes that there is a reasonable certainty that no harm will result from acute dietary ( food) exposure to residues arising from the current and proposed uses for thiamethoxam.

Chronic Exposure The thiamethoxam chronic dietary ( food only) risk assessment was performed for all population subgroups using a chronic reference dose ( cRfD) of 0.041 mg/ kg bw/ day based upon a twelvemonth study in dogs with a no observable adverse effect level ( NOAEL) of 4.1 mg/ kg/ day and an uncertainty factor of 100X ( factor includes intra and inter species variations . No additional FQPA was applied. For the purpose of aggregate risk assessment, the exposure values were 7 expressed in terms of margin of exposure ( MOE), which was calculated by dividing the NOAEL by the exposure for each population subgroup. In addition, exposure was expressed as a percent of the chronic reference dose (% RfD). Chronic ( food only) exposure to the U. S. population resulted in an MOE of 1,633 ( 6.1% of the RfD of 0.041 mg/ kg bw/ day). The most exposed subpopulation was children ( 1 2 years old) with an MOE of 582 ( 17.2% of the RfD). Since the benchmark MOE for this assessment was 100 and since EPA generally has no concern for exposures below 100% of the RfD, Syngenta believes that there is a reasonable certainty that no harm will result from chronic dietary ( food) exposure to residues arising from the current and proposed uses for thiamethoxam.

Cancer A quantitative risk assessment for cancer is not required.

ii. Drinking water. The EPA uses the screening model FIRST to estimate potential surface water concentrations and the screening model SCI GROW to estimate potential ground water concentrations. None of these models include consideration of the impact of processing ( mixing, dilution, or treatment) would have on the removal of pesticides from the water source prior to distribution as drinking water. The primary use of these models is to provide a conservative approximation of the Estimated Drinking Water Concentrations ( EDWCs) of specific pesticides in drinking water. These models were used by Syngenta to provide EDWCs of thiamethoxam for a proposed use on turf grass at a maximum application rate of 0.266 lb ai/ A using ground application equipment. Note that the surface water modeling utilized a highly conservative percent cropped area ( PCA) of 100% to provide a theoretical worst case estimate of thiamethoxam exposure based upon the unlikely assumption that the entire watershed is both covered with turf and treated by ground application on the same day at the maximum label rate. Based upon these assumptions, Syngenta calculated the highest screening level EDWCs of 25.687 ppb for acute surface water and 4.12 ppb for chronic ground water.

Acute Exposure from Drinking Water The acute EDWC of 25.697 ppb ( surface water) was used to calculate the acute drinking water exposure values for the U. S. Population and population subgroups. Acute drinking water estimates were incorporated directly into the DEEM FCIDTM software along with current, pending and proposed uses of thiamethoxam. Acute exposure ( food and water) to the U. S. Population resulted in an MOE of 12,008 ( 0.83% of the RfD). The most exposed subpopulation was children ( 1 2 years old) with an MOE of 5,328 ( 1.88% of the aRfD). Since the benchmark MOE for this assessment was 100 and since EPA generally has no concern for exposures below 100% of the RfD, Syngenta believes that there is a reasonable certainty that no harm will result from chronic dietary ( food) exposure to residues arising from the current and proposed uses for thiamethoxam. 8 Chronic Exposure form Drinking Water: The chronic EDWC of 4.12 ppb ( groud water) was used to calculate the chronic drinking water exposure values for the U. S. Population and population subgroups. Chronic drinking water estimates were incorporated directly into DEEM FCIDTM software along with current, pending and proposed uses of thiamethoxam. Chronic exposure ( food and water) to the U. S. Population resulted in an MOE of 1,578 ( 6.3% of the cRfD). The most exposed sub population was children ( 1 2 years old) with an MOE of 572 ( 17.5% of the cRfD). Since the benchmark MOE for this assessment was 100 and since EPA generally has no concern for exposures below 100% of the RfD, Syngenta believes that there is a reasonable certainty that no harm will result from chronic dietary ( food) exposure to residues arising from the current and proposed uses for thiamethoxam.

2. Non dietary exposure. Residential ( non occupational) short term risk assessments were conducted for professional uses of thiamethoxam on residential turf with a maximum rate of 0.266 lbs ai/ A ( one application per year). Based upon the use pattern, there is no residential handler exposure and only short term exposures were investigated since use of the turf product would not be expected to exceed 30 days. The following endpoints were used for these residential risk assessments: NOAEL= 30 mg/ kg/ day ( short term oral from a rat developmental toxicity study) and NOAEL= 60 mg/ kg/ day ( short term dermal fro a 28 day dermal study in rats). Post application dermal exposure risks were evaluated for adults re entering treated yards. The resultant short term MOE for adults is 832 which is above the benchmark MOE of 100 and thus does not exceed EPA's level of concern. Post application dermal exposure risks were also evaluated for children ( 1 5 years old) re entering treated yards. Additionally, post application oral exposure risks were assessed for children engaged in hand to mouth, object to mouth and treated soil ingestion activities. The resultant combined short term MOE for children is 529 which is above the benchmark MOE of 100 and thus does not exceed EPA's level of concern.

D. Cumulative Effects Cummulative Exposure to Substances with a Common Mechanism of Toxicity. Section 408( b)( 2)( D)( v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider " available information" concerning the the cummulative effects of a particular pesticide's residues and " other substances that have a common mechanism of toxicity". Unlike other pesticides for which EPA has followed a cummulative risk approach based upon a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to thiamethoxam and any other substances and thaimethoxam does not appear to produce a toxic metabolite produced by other substances. For the purposes of htis tolerance action, the EPA has not assumed that thiamethoxam has a common mechanism of toxicity with other substances. 9 E. Safety Determination 1. U. S. population. The acute dietary exposure analysis ( food plus water) and chronic dietary exposure analysis ( food plus water) showed that exposure to the U. S. Population from all established, pending and proposed uses is well above the benchmark MOE of 100 with MOEs of 12,008( 0.83% of aRfD) and 1,578 ( 6.3% of cRfD), respectively. A short term aggregate exposure analysis ( food, water and residential) was required for adults because there is a postapplication dermal exposure scenario from re entry into treated turf. The corresponding MOEs were aggregated using the inverse MOE approach. For short term exposures, the dietary ( food and water) exposure ( MOE 11,547) was aggregated with residential exposure ( MOE 832) resulting in a short term aggregate MOE of 776 for the U. S. Population which exceeds the benchmark MOE of 100. An intermediate term aggregate exposure analysis ( food plus water plus residential) was not required for adults because residential turf exposures are not expected to occur for longer than a short time frame. Based upon the completeness and reliability of the toxicity data supporting these petitions, Syngenta believes that there is a reasonable certainty that no harm will result from aggregate exposure to residues arising from all currnet, pending and proposed thiamethoxam uses, including anticipated dietary exposure from food, water and all other types of non occupational exposures. ]

2. Infants and children. The acute dietary exposure analysis ( food plus water) showed that exposure from all established, pending and proposed uses would result in an MOE of 5,328 ( 1.88% of the aRfD) for the most sensitive population subgroup, children 1 2 years old, which exceeds the benchmark MOE of 100. The chronic aggregate dietary ( food plus water) exposure analysis showed that exposure form all established, pending and proposed thiamethoxam uses would result in an MOE of 572 ( 17.5% of hte cRfD) fo rthe most sensitive population subgroup, children 1 2 years old, which exceeds the benchmark MOE of 100. A short term aggregate exposure analysis ( food, water and residential) was required for toddlers because there are residential post application dermal and oral exposure scenarios from re entry into treated turf. For short term exposures, the dietary ( food plus water) exposure ( MOE 4,184) was aggregated with residential exposure ( MOE 529) resulting in a short term aggregate MOE of 470 for the most sensitive population subgroup, children 1 2 years old, which exceeds the benchmark MOE of 100. An intermediate term aggregate exposure analysis was not required for children because residential turf exposures are not expected to occur for longer than a short term time frame. Based upon the completeness and reliability of the toxicity data supporting these petitions, Syngenta believes that there is a reasonable certainty that no harm will result from aggregate exposure to residues arising from all current, pending and proposed thiamethoxam uses, including anticipated dietary exposure from food, water and all other types of non occupational exposures.

F. International Tolerances 10 [ There are no Codex MRLs established for residues of thiamethoxam.]


[Federal Register Volume 87, Number 132 (Tuesday, July 12, 2022)]
[Notices]
[Page 41307]
[FR Doc No: 2022-14787]

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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 in Existing Proceedings

    Docket Numbers: RP21-1042-004.
    Applicants: Rover Pipeline LLC.
    Description: Compliance filing: RP21-1042 Settlement Compliance
Filing to be effective 8/1/2022.
    Filed Date: 7/6/22.
    Accession Number: 20220706-5043.
    Comment Date: 5 p.m. ET 7/18/22.

    Docket Numbers: RP21-441-007.
    Applicants: Florida Gas Transmission Company, LLC.
    Description: Compliance filing: RP21-441 Settlement Compliance
Filing to be effective 8/1/2022.
    Filed Date: 7/6/22.
    Accession Number: 20220706-5039.
    Comment Date: 5 p.m. ET 7/18/22.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.

Filings Instituting Proceedings

    Docket Numbers: RP22-1043-000.
    Applicants: Equitrans, L.P.
    Description: Sec.  4(d) Rate Filing: Remove Terminated Agreement--
7/31/2022 to be effective 8/5/2022.
    Filed Date: 7/5/22.
    Accession Number: 20220705-5045.
    Comment Date: 5 p.m. ET 7/18/22.

    Docket Numbers: RP22-1044-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--UGI to DTE
eff 7-2-22 to be effective 7/2/2022.
    Filed Date: 7/5/22.
    Accession Number: 20220705-5110.
    Comment Date: 5 p.m. ET 7/18/22.

    Docket Numbers: RP22-1045-000.
    Applicants: NEXUS Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Amended DTE
860002 eff 07-01-22 to be effective 7/1/2022.
    Filed Date: 7/6/22.
    Accession Number: 20220706-5000.
    Comment Date: 5 p.m. ET 7/18/22.

    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.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    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: July 6, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-14787 Filed 7-11-22; 8:45 am]
BILLING CODE 6717-01-P