[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Rules and Regulations]
[Pages 15576-15577]
[FR Doc No: 2012-6010]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30831; Amdt. No. 3468]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective March 16, 2012. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of March 16, 2012.

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169 or
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    Availability--All SIAPs and Takeoff Minimums and ODPs are available
online free of charge. Visit http://www.nfdc.faa.gov to register.
Additionally, individual SIAP and Takeoff Minimums and ODP copies may
be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Richard A. Dunham III, Flight
Procedure Standards Branch (AFS-420), Flight Technologies and Programs
Divisions, Flight Standards Service, Federal Aviation Administration,
Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd. Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125)
Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14 of the Code of
Federal Regulations, Part 97 (14 CFR part 97), by establishing,
amending, suspending, or revoking SIAPS, Takeoff Minimums and/or ODPS.
The complete regulators description of each SIAP and its associated
Takeoff Minimums or ODP for an identified airport is listed on FAA form
documents which are incorporated by reference in this amendment under 5
U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA
Forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when
required by an entry on 8260-15A.
    The large number of SIAPs, Takeoff Minimums and ODPs, in addition
to their complex nature and the need for a special format make
publication in the Federal Register expensive and impractical.
Furthermore, airmen do not use the regulatory text of the SIAPs,
Takeoff Minimums or ODPs, but instead refer to their depiction on
charts printed by publishers of aeronautical materials. The advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP, Takeoff Minimums and ODP listed on
FAA forms is unnecessary. This amendment provides the affected CFR
sections and specifies the types of SIAPs and the effective dates of
the, associated Takeoff Minimums and ODPs. This amendment also
identifies the airport and its location, the procedure, and the
amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums and ODP as contained in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flight safety relating directly to published aeronautical charts. The
circumstances which created the need for some SIAP and Takeoff Minimums
and ODP amendments may require making them effective in less than 30
days. For the remaining SIAPS and Takeoff Minimums and ODPS, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPS contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPS and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find that notice and
public procedures before adopting these SIAPS, Takeoff Minimums and
ODPs are impracticable and contrary to the public interest and, where
applicable, that good cause exists for making some SIAPs effective in
less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule '' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air traffic control, Airports, Incorporation by reference, and
Navigation (air).

    Issued in Washington, DC on March 2, 2012.
John McGraw,,
Deputy Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by
establishing, amending, suspending, or revoking Standard Instrument
Approach Procedures and/or Takeoff Minimums and/or Obstacle Departure
Procedures effective at 0902 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Effective 5 APR 2012

Bethel, AK, Bethel, ILS OR LOC/DME Y RWY 19R, Orig
Bethel, AK, Bethel, ILS OR LOC/DME Z RWY 19R, Amdt 7
Bethel, AK, Bethel, RNAV (GPS) RWY 19R, Amdt 2
Jasper, AL, Walker County-Bevill Field, RNAV (GPS) RWY 9, Orig
Scottsdale, AZ, Scottsdale, RNAV (GPS)-D, Amdt 1
Scottsdale, AZ, Scottsdale, RNAV (GPS)-E, Amdt 1
Scottsdale, AZ, Scottsdale, VOR-C, Amdt 2
Scottsdale, AZ, Scottsdale, VOR/DME-A, Amdt 3
Georgetown, DE, Sussex County, Takeoff Minimums and Obstacle DP, Amdt 3
Laurel, DE, Laurel, GPS-A, Orig-A, CANCELLED
Laurel, DE, Laurel, RNAV (GPS)-A, Orig
Laurel, DE, Laurel, Takeoff Minimums and Obstacle DP, Amdt 2
Miami, FL, Kendall-Tamiami Executive, ILS OR LOC RWY 9R, Amdt 11
Orlando, FL, Executive, ILS OR LOC/DME RWY 25, Orig
Orlando, FL, Executive, LOC BC RWY 25, Amdt 21B, CANCELLED
Orlando, FL, Executive, LOC RWY 25, Orig
Orlando, FL, Executive, RNAV (GPS) RWY 25, Amdt 1
Ormond Beach, FL, Ormond Beach Muni, GPS RWY 8, Orig-A, CANCELLED
Ormond Beach, FL, Ormond Beach Muni, RADAR 1, Amdt 2C, CANCELLED
Ormond Beach, FL, Ormond Beach Muni, RNAV (GPS) RWY 8, Orig
Ormond Beach, FL, Ormond Beach Muni, RNAV (GPS) RWY 17, Orig
Ormond Beach, FL, Ormond Beach Muni, RNAV (GPS) RWY 26, Orig
Ormond Beach, FL, Ormond Beach Muni, VOR RWY 17, Amdt 2
Honolulu, HI, Honolulu Intl, ILS Y RWY 4R, Amdt 1
Honolulu, HI, Honolulu Intl, ILS Z RWY 4R, Amdt 1
Honolulu, HI, Honolulu Intl, LOC/DME RWY 4R, Amdt 1
Honolulu, HI, Honolulu Intl, RNAV (GPS) Y RWY 4R, Amdt 2
Honolulu, HI, Honolulu Intl, RNAV (RNP) Z RWY 4R, Amdt 1
Honolulu, HI, Honolulu Intl, RNAV (RNP) Z RWY 8L, Amdt 1
Chariton, IA, Chariton Muni, RNAV (GPS) RWY 17, Amdt 1
Chariton, IA, Chariton Muni, VOR OR GPS RWY 17, Amdt 1A, CANCELLED
Independence, IA, Independence Muni, NDB RWY 18, Amdt 3
Independence, IA, Independence Muni, RNAV (GPS) RWY 18, Orig
Independence, IA, Independence Muni, RNAV (GPS) RWY 36, Orig
Red Oak, IA, Red Oak Muni, NDB RWY 17, Amdt 9, CANCELLED
Red Oak, IA, Red Oak Muni, RNAV (GPS) RWY 5, Amdt 1
Carmi, IL, Carmi Muni, NDB RWY 36, Amdt 1A, CANCELLED
Bar Harbor, ME, Hancock County-Bar Harbor, ILS OR LOC RWY 22, Amdt 6A
Fayetteville, NC, Fayetteville Rgnl/Grannis Field, ILS OR LOC/DME RWY
4, Amdt 16A
Fayetteville, NC, Fayetteville Rgnl/Grannis Field, LOC BC RWY 22, Amdt
8
Fayetteville, NC, Fayetteville Rgnl/Grannis Field, RNAV (GPS) RWY 4,
Amdt 2
Fayetteville, NC, Fayetteville Rgnl/Grannis Field, RNAV (GPS) RWY 22,
Amdt 4
Pinehurst/Southern Pines, NC, Moore County, ILS OR LOC RWY 5, Amdt 1
Pinehurst/Southern Pines, NC, Moore County, RNAV (GPS) RWY 23, Amdt 1
Chadron, NE, Chadron Muni, ILS OR LOC RWY 2, Amdt 2A
Chadron, NE, Chadron Muni, NDB RWY 20, Amdt 12A
Chadron, NE, Chadron Muni, RNAV (GPS) RWY 2, Amdt 1
Chadron, NE, Chadron Muni, RNAV (GPS) RWY 20, Amdt 2
Lincoln, NE, Lincoln, ILS OR LOC RWY 18, Amdt 7
Lincoln, NE, Lincoln, ILS OR LOC RWY 36, Amdt 11G
Findlay, OH, Findlay, VOR RWY 25, Amdt 5A, CANCELLED
Findlay, OH, Findlay, VOR RWY 36, Amdt 6B, CANCELLED
Bloomsburg, PA, Bloomsburg Muni, Takeoff Minimums and Obstacle DP, Amdt
1
Reedsville, PA, Mifflin County, LOC RWY 6, Amdt 8A
Nashville, TN, Nashville Intl, RNAV (GPS) RWY 20C, Orig
Smithville, TN, Smithville Muni, RNAV (GPS) RWY 6, Amdt 2
Smithville, TN, Smithville Muni, RNAV (GPS) RWY 24, Amdt 2
Houston, TX, Ellington Field, RNAV (GPS) RWY 17R, Amdt 1
Houston, TX, Ellington Field, RNAV (GPS) RWY 22, Amdt 1A
Kerrville, TX, Kerrville Muni/Louis Schreiner Field, LOC RWY 30, Amdt
4A
Kerrville, TX, Kerrville Muni/Louis Schreiner Field, RNAV (GPS) RWY 12,
Amdt 1
Kerrville, TX, Kerrville Muni/Louis Schreiner Field, RNAV (GPS) RWY 30,
Orig-A

[FR Doc. 2012-6010 Filed 3-15-12; 8:45 am]
BILLING CODE 4910-13-P


"Johansson, Robert"<EMAIL_ADDRESS> 10/01/2007 10:18 AM

To

"Johansson, Robert"<EMAIL_ADDRESS>"Baer, Mitchell" <EMAIL_ADDRESS><EMAIL_ADDRESS>"Farrell, Amy L."<EMAIL_ADDRESS>"Laur, Michele - Washington, DC" <EMAIL_ADDRESS><EMAIL_ADDRESS>Ron Evans/RTP/USEPA/US@EPA, "Schwab, Margo"<EMAIL_ADDRESS> cc

"Fraas, Arthur G."<EMAIL_ADDRESS> Subject

RE: RIA NAAQS Workshop

It looks like EPA will be cutting down on staff time for this workshop to the afternoon of the 17th and the morning of the 18th.

This would allow folks to drive down from DC on Wednesday early morning and to drive back to DC late Thursday afternoon.

Please identify the content from the agenda below that you would like to focus on.

Thanks,

Rob

Day 1 - Wednesday, October 17

10:00 am - Kickoff (Ron Evans)

10:10 am - Comparison of NAAQS RIA and Risk Assessments (Bryan Hubbell)

10:30 am - Overview of RIA Process (Bryan Hubbell)

What are the Goals of the RIA?

What is the Scope?

What is outside of the Scope?

What is the timeline?

What are the components of the RIA?

11:00 am – Break

11:10 am - Role of AQ Modeling in the RIA (Norm Possiel and Pat Dolwick)

What are air quality models?

What are the key inputs to and outputs from air quality models?

How is international transport treated in air quality modeling?

What are the steps/timing for air quality model applications?

How are air quality models used to project future attainment/nonattainment?

How are air quality models used to provide inputs for calculating benefits?

How are air quality models or tools used to inform control strategy development?

12:00 pm – Lunch

1:00 pm - Overview of the Modeling Platform (Rich Mason)

What are the differences between the 2002 and 2001 Platforms?

How are International and Natural Emissions treated in the Emission Inventory?

What are the growth assumptions for the 2020 Inventory?

How are differences in the 2002 and 2001 platforms reflected in the 2020 inventories used for proposal and final?

2:00 pm – Break

2:10 pm - Discussion

3:00 pm - Preparation of Control Strategies (Serpil Kayin, Kevin Culligan, Darryl Weatherhead, Ken Adler, David Misenheimer, Rich Mason)

How are geographic areas selected for analysis of control measures?

How are EGU strategies prepared?

How are nonEGU Point and Area strategies prepared?

How are Mobile strategies prepared?

What role do engineering costs play in selection of control strategies?

How are incremental emission reductions calculated?

How are engineering costs calculated?

How are emission inputs prepared for the air quality model?

4:30 pm – Discussion

5:00 pm – Break for the Day

Day 2 - Thursday, October 18

8:30 am - Economic Impacts and Extrapolated Costs (Darryl)

How are economic impacts of known controls estimated?

What is the role of EMPAX?

How are extrapolated control costs estimated?

Why don’t we do EMPAX modeling for extrapolated costs?

10:00 am – Break

10:10 am – Discussion

11:00 am - Benefits Analysis – Interpolations, Extrapolations, and Sensitivity Analyses for O3 (Neal Fann)

How are human health and dollar benefits estimated?

How are we estimating full attainment benefits?

How do we "roll back" air quality monitors?

How do we interpolate benefits?

Are you performing a UVB analysis?

Will we perform a cost effectiveness analysis for ozone?

12:00 pm – Lunch

1:00 pm – Discussion

2:00 pm – Upcoming Rules and Schedules (Ron)

What are the schedules, methodological differences, and challenges of the NOx, SOx, Lead NAAQS RIAs?

2:30 pm – Break

2:40 pm – Ancillary Analyses (Nathalie Simon)

Cost effectiveness analyses

UVB analysis

2:50 pm – Other Impacts (Bryan)

Air Toxics Benefits

Ecological Benefits

Visibility

Agriculture

Forestry

NOx/SO2 Deposition

Materials Damage

3:10 pm – Discussion

4:30 pm – Break for the Day


[Federal Register Volume 82, Number 218 (Tuesday, November 14, 2017)]
[Rules and Regulations]
[Pages 52669-52674]
[FR Doc No: 2017-24109]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0448; FRL-9967-33]

Benzovindiflupyr; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
benzovindiflupyr in or on the bulb onion subgroup 3-07A, the green
onion subgroup 3-07B, and increases an existing tolerance on sugarcane.
Interregional Research Project Number 4 (IR-4) and Syngenta Crop
Protection requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective November 14, 2017. Objections and
requests for hearings must be received on or before January 16, 2018,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2016-0448, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure

proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2016-0448 in the subject line on the first page of your submission. All
objections and requests for a hearing must be in writing, and must be
received by the Hearing Clerk on or before January 16, 2018. Addresses
for mail and hand delivery of objections and hearing requests are
provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2016-0448, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 18, 2016 (81 FR 71668) (FRL-
9952-19), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6E8483) by IR-4, Rutgers, The State University of New Jersey, 500
College Road East, Suite 201-W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.686 be amended by establishing tolerances for
residues of the fungicide benzovindiflupyr (N-[9-(dichloromethylene)-
1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-
methyl-1H-pyrazole-4-carboxamide) in or on onion, bulb, subgroup 3-07A
at 0.02 parts per million (ppm), and onion, green, subgroup 3-07B at
0.4 ppm.
    In the Federal Register of July 26, 2017 (82 FR 34664) (FRL-9963-
50), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6F8499) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419. The petition requested to establish a tolerance in 40 CFR
part 180 for residues of the fungicide benzovindiflupyr in or on
Sugarcane, cane, at 0.3 ppm.
    The documents referenced summaries of the petitions prepared by
Syngenta Crop Protection, LLC, the registrant, which are available in
the dockets EPA-HQ-OPP-2016-0448 and EPA-HQ-OPP-2016-0752 at http://www.regulations.gov. There were no comments received in response to
either notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for benzovindiflupyr including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with
benzovindiflupyr follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The rat is the most sensitive species tested, and the target organs
of benzovindiflupyr are the liver, thyroid, and kidneys. Hepatotoxicity
was manifested as changes in liver weights, liver hypertrophy, and
decreased triglycerides. The kidney effects were tubular cell pigment
deposits, changes in the tubular basophilia, and increased urea.
Enlargement and focal c-cell hyperplasia of the thyroid were observed.
An increased incidence of cell hypertrophy in the pituitary pars
distalis was noted in the F1 generation males and females in the 2-
generation reproductive toxicity rat study. Mouse studies revealed
distended large intestines, soft feces and hyperplasia of the colon and
caecum. Indications of general malaise including decreased body weight
and food consumption, decreased activity, decreased grip strength,
piloerection, decreased response to stimulus, hunched posture, gait
changes and/or ataxia were reported in the rat and mouse studies. In
several studies, females tended to be more sensitive than males and
effects were generally seen at lower doses with gavage dosing than with
dietary dosing.
    There are no concerns for developmental or reproductive toxicity
following benzovindiflupyr exposure. Decreased fetal weight and
ossification in the rat developmental toxicity studies occurred at
maternally toxic doses. There were no maternal or fetal adverse effects
in the rabbit developmental study. In rat reproduction studies,
offspring effects (decreased body weight, liver and pituitary effects)
occurred at doses higher than those causing parental effects; thus,
there was no quantitative increase in sensitivity in rat pups. There
were no single-dose developmental effects identified in the
developmental toxicity studies in rats or rabbits. Although decreases
in growing follicle counts were noted in the 2-generation reproduction
toxicity study, this effect did not result in reduced fertility in the
rat. Furthermore, the antral follicle counts at a later stage in
development were not decreased, so the decreased growing follicle count
effect is not considered adverse.
    No evidence of specific neurotoxicity was observed in the acute
oral (gavage) and sub-chronic oral (dietary) neurotoxicity (ACN and
SCN) studies in rats, conducted on the benzovindiflupyr technical
product. Although

benzovindiflupyr caused decreased activity and decreased grip strength
in the neurotoxicity studies, there was no supportive neuro-
histopathology in any study to indicate a specific neurotoxic effect.
    The mouse immunotoxicity study was negative by the T-cell Dependent
Antigen Response (TDAR) assay in the mouse.
    No systemic effects were noted at the limit dose of 1,000
milligrams/kilogram/day (mg/kg/day) in the 28-day dermal rat study.
    The Agency classified benzovindiflupyr as showing ``Suggestive
Evidence of Carcinogenic Potential'' based on the presence of granular
cell tumors of the brain in male rats only at the highest dose tested.
The Agency concluded that a non-genotoxic mode of action for thyroid
tumors observed in male rats has been established as a result of
upregulation of uridine diphosphate glucuronyltransferase (UDPGT),
increased clearance of T3 and T4 hormones, and increased TSH levels,
resulting in increased thyroid cell proliferation, which progress to
form thyroid tumors. There was no evidence of carcinogenicity in female
rats or in male or female mice. In addition, there is no concern for
mutagenicity. The Agency has determined that using a non-linear
approach (i.e., RfD; reference dose) will adequately account for all
chronic toxicity, including carcinogenicity, that could result from
exposure to benzovindiflupyr.
    Specific information on the studies received and the nature of the
adverse effects caused by benzovindiflupyr as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Benzovindiflupyr. Human
Health Risk Assessment for the Proposed Use on Onion, Bulb Subgroup 3-
07A; Onion, Green, Subgroup 3-07B; and Sugarcane'' on pages 32-38 in
docket ID number EPA-HQ-OPP-2016-0448.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for benzovindiflupyr used
for human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of October 2, 2015 (80 FR 59627)
(FRL-9933-03).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to benzovindiflupyr, EPA considered exposure under the
petitioned-for tolerances as well as all existing benzovindiflupyr
tolerances in 40 CFR 180.686. EPA assessed dietary exposures from
benzovindiflupyr in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for benzovindiflupyr. In estimating
acute dietary exposure, EPA used 2003-2008 food consumption information
from the U.S. Department of Agriculture's (USDA's) National Health and
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).
As to residue levels in food, EPA assumed 100 percent crop treated
(PCT) and tolerance-level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used 2003-2008 food consumption data from the USDA's
NHANES/WWEIA. As to residue levels in food, EPA assumed 100 PCT and
tolerance-level residues.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach adequately accounts for all
chronic toxicity, including carcinogenicity, that could result from
exposure to benzovindiflupyr; therefore, a separate dietary cancer risk
assessment was not performed.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
benzovindiflupyr. Tolerance-level residues and 100 PCT were assumed for
all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for benzovindiflupyr in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of benzovindiflupyr. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Surface Water Concentration Calculator (SWCC) model
and the Pesticide Root Zone Model Ground Water (PRZM-GW) model, the
estimated drinking water concentrations (EDWCs) of benzovindiflupyr for
acute exposures are estimated to be 8.41 parts per billion (ppb) for
surface water and 0.14 ppb for ground water and for chronic exposures
are estimated to be 5.41 ppb for surface water and 0.14 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the acute dietary risk
assessment, the water concentration value of 8.41 ppb was used to
assess the contribution to drinking water. For the chronic dietary risk
assessment, the water concentration of value 5.41 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Benzovindiflupyr is currently registered for the following uses
that could result in residential exposures: Turf and ornamentals. EPA
assessed residential exposure using the following assumptions: For
handlers, exposure is expected as a result of application to turf and
ornamentals. Post-application exposure is also expected as a result of
being in an environment that has been previously treated with
benzovindiflupyr. Both handler and

post-application exposure is short-term in duration; there are no
intermediate- or long term-exposures expected from the residential uses
of benzovindiflupyr. Only residential handler inhalation and post-
application incidental oral exposure scenarios have been quantitatively
assessed since no dermal hazard was identified. Residential handler
short-term inhalation MOEs are well above the LOC of 100 for all
scenarios assessed and are not of concern (inhalation MOEs are
>=180,000). Residential post-application (incidental oral) MOEs for
children ranged from 8,000 to 3,600,000 on the day of application,
using default input values, and are not of concern (LOC = 100).
    The residential scenarios used for the benzovindiflupyr aggregate
assessments were as follows: Adults: Inhalation exposures from treating
ornamentals with a manually pressurized handwand or backpack sprayer;
Children 1 to <2 years old: Post-application hand-to-mouth exposures
from treated turf. These scenarios resulted in the highest residential
exposures and are considered protective of other exposure scenarios.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from 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 cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found benzovindiflupyr to share a common mechanism of
toxicity with any other substances, and benzovindiflupyr does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
benzovindiflupyr does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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 database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of
quantitative or qualitative susceptibility in fetuses or offspring in
the rat and rabbit developmental studies or in the 2-generation rat
reproduction study. Benzovindiflupyr produced effects in rat fetuses
(i.e., decreased fetal weight and ossification) in developmental
toxicity studies at maternally toxic doses. In the rabbit developmental
study, there were no adverse effects in either the does or the fetuses
at the highest dose tested. In reproduction studies, offspring effects
occurred at doses higher than the doses causing parental effects; thus,
there was no quantitative increase in sensitivity in rat pups. The
LOAELs and NOAELs for the rat developmental and rat reproduction
studies were clearly defined.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for benzovindiflupyr is complete.
    ii. There is no indication that benzovindiflupyr is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that benzovindiflupyr results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to benzovindiflupyr in drinking water. EPA used
similarly conservative assumptions to assess post-application exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
benzovindiflupyr.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to benzovindiflupyr will occupy 43% of the aPAD for children 1-2 years
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
benzovindiflupyr from food and water will utilize 19% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
benzovindiflupyr is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Benzovindiflupyr is currently registered for uses that could result
in short-term residential exposure, and the Agency has determined that
it is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to benzovindiflupyr.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 2100 for adults
and 510 for children. Because EPA's level of concern for
benzovindiflupyr is a MOE

of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    An intermediate-term adverse effect was identified; however,
benzovindiflupyr is not registered for any use patterns that would
result in intermediate-term residential exposure. Intermediate-term
risk is assessed based on intermediate-term residential exposure plus
chronic dietary exposure. Because there is no intermediate-term
residential exposure and chronic dietary exposure has already been
assessed under the appropriately protective cPAD (which is at least as
protective as the POD used to assess intermediate-term risk), no
further assessment of intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for benzovindiflupyr.
    5. Aggregate cancer risk for U.S. population. Based on the
discussion in Unit III.A., EPA considers the chronic aggregate risk
assessment to be protective of any aggregate cancer risk. As there is
no chronic risk of concern, EPA does not expect any cancer risk to the
U.S. population from aggregate exposure to benzovindiflupyr.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to benzovindiflupyr residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical method is available to enforce the proposed
tolerances for benzovindiflupyr in plant and livestock commodities. A
Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) multi-
residue method (EN15662:2009) was developed for the determination of
residues of benzovindiflupyr via liquid chromatography-mass
spectrometry/mass spectrometry (LC-MS/MS).
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established any MRLs for benzovindiflupyr.

V. Conclusion

    Therefore, tolerances are established for residues of
benzovindiflupyr, including its metabolites and degradates, in or on
onion, bulb, subgroup 3-07A at 0.02 ppm; onion, green, subgroup 3-07B
at 0.40 ppm; and the existing ``sugarcane, cane'' tolerance is
increased from 0.04 ppm to 0.30 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: October 12, 2017.
Michael L. Goodis,
Director Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.686, amend the table in paragraph (a) by:
0
i. Adding alphabetically the commodities ``Onion, bulb, subgroup 3-
07A'', ``Onion, green, subgroup 3-07B'', and
0
ii. Revising the commodity ``Sugarcane, cane''.
    The additions and revisions read as follows:

Sec.  180.686  Benzovindiflupyr; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Onion, bulb, subgroup 3-07A..................................       0.02
Onion, green, subgroup 3-07B.................................       0.40

                                * * * * *
Sugarcane, cane..............................................       0.30

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-24109 Filed 11-13-17; 8:45 am]
 BILLING CODE 6560-50-P