[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)]
[Notices]
[Pages 54134-54137]
[FR Doc No: 2016-19320]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78517; File No. SR-BatsBZX-2016-44]

Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Related to
Fees for Use of the Exchange's Options Platform

August 9, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on July 29, 2016, Bats BZX Exchange, Inc. (the ``Exchange'' or
``BZX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. The
Exchange has designated the proposed rule change as one establishing or
changing a member due, fee, or other charge imposed by the Exchange
under Section 19(b)(3)(A)(ii) of the Act\3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposed rule change effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to amend the fee schedule applicable
to Members \5\ and non-Members of the Exchange pursuant to BZX Rules
15.1(a) and (c).
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    \5\ The term ``Member'' is defined as ``any registered broker or
dealer that has been admitted to membership in the Exchange.'' See
Exchange Rule 1.5(n).
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    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant parts of such
statements.

(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to modify its fee schedule applicable to the
Exchange's options platform (``BZX Options'') to: (i) Increase the fee
for orders that yield fee code NP, which is appended Non-Customer \6\
orders in Non-Penny Pilot Securities; \7\ (ii) add three new tiers
under new footnote 13 entitled, ``Non-Customer Non-Penny Pilot Take
Volume Tier''; (iii) eliminate Tier 4 from footnote 5, Quoting
Incentive Program (``QIP'') Tier; and (iv) modify the billing policy
for the logical port fees.
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    \6\ As defined in the Exchange's fee schedule available at
http://www.batsoptions.com/support/fee_schedule/bzx/.
    \7\ Id.
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Fee Code NP
    Fee code NP is appended to Non-Customer orders that remove
liquidity in Non-Penny Pilot Securities on the Exchange. Orders that
yield fee code NP currently incur a fee of $0.99 per contract. The
Exchange is proposing to increase this fee to $1.07 per contract, which
as explained below, is commensurate with industry standards.

In conjunction with this change, the Exchange also proposes to update
the Standard Rate table.
Non-Customer Non-Penny Pilot Take Volume Tier
    The Exchange proposes to add three tiers under new footnote 13
entitled, ``Non-Customer Non-Penny Pilot Take Volume Tier''. Under the
proposed new tiers, orders that yield fee code NP would receive a
discounted rate from the proposed $1.07 fee discussed above. The
Exchange proposes to add three Non-Customer Non-Penny Pilot Take Volume
Tiers, as set forth below.
     Tier 1, would provide a discounted rate of $1.02 in orders
where: the (1) Member has an ADAV \8\ in Customer \9\ orders equal to
or greater than 0.60% of average TCV \10\; (2) Member has an ADAV in
Market Maker \11\ orders equal to or greater than 0.30% of average TCV;
and (3) Member has on Exchange's equity platform (``BZX Equities'') an
ADAV \12\ equal to or greater than 0.30% of average TCV.
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    \8\ Id.
    \9\ Id.
    \10\ Id.
    \11\ As defined in the Exchange's fee schedule available at
http://www.batsoptions.com/support/fee_schedule/bzx/.
    \12\ As defined in the BZX Equities' fee schedule available at
http://batstrading.com/support/fee_schedule/bzx/.
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     Tier 2, would provide a discounted rate of $1.02 in orders
where a Member has an ADAV in Customer orders equal to or greater than
1.00% of average TCV.
     Tier 3, would provide a discounted rate of $1.01 in orders
where a Member has an ADAV in Customer orders equal to or greater than
1.30% of average TCV.
    The Exchange notes that the criteria necessary to achieve the
discounted rate under Tiers 1, 2, and 3 proposed above mirrors the
criteria required by the existing Non-Customer Penny Pilot Take Volume
Tiers under footnote 3 of the Exchange's fee schedule. In conjunction
with the addition of footnote 13, the Exchange also proposes to append
footnote 13 to fee code NP within the Fee Codes and Associate Fees
table and update the Standard Rates table.
Quoting Incentive Program (``QIP'') Tier
    The Exchange currently offers four QIP tiers which provide an
additional rebate per contract for an order that adds liquidity to the
BZX Options Book in options classes in which a Member is a Market Maker
registered on BZX Options pursuant to Rule 22.2. The Market Maker must
be registered with BZX Options in an average of 20% or more of the
associated options series in a class in order to qualify for QIP
rebates for that class. Under the QIP Tiers, a Market Maker receives an
additional rebate ranging from $0.02 to $0.06 per contract where that
Market Maker satisfies certain ADV \13\ thresholds. Under the highest
tier, QIP Tier 4, a Market Maker receives an additional rebate of $0.06
per contract where that Market Maker has an ADV equal to or greater
than 3.5% of average TCV. The Exchange proposes to eliminate QIP Tier 4
because the rebate has not achieved the desired effect, despite being
designed to incentivize Market Markers to add liquidity to the BZX
Options Book.
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    \13\ As defined in the Exchange's fee schedule available at
http://www.batsoptions.com/support/fee_schedule/bzx/.
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Logical Port Fees
    A logical port represents a port established by the Exchange within
the Exchange's system for trading and billing purposes. Each logical
port established is specific to a Member or non-Member and grants that
Member or non-Member the ability to operate a specific application,
such as FIX order entry or PITCH data receipt. The Exchange's Multicast
PITCH data feed is available from two primary feeds, identified as the
``A feed'' and the ``C feed'', which contain the same information but
differ only in the way such feeds are received. The Exchange also
offers two redundant fees, identified as the ``B feed'' and the ``D
feed.'' The Exchange also offers a bulk-quoting interface which allows
Users \14\ of BZX Options to submit and update multiple bids and offers
in one message through logical ports enabled for bulk-quoting. The
bulk-quoting application for BZX Options is a particularly useful
feature for Users that provide quotations in many different options.
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    \14\ A User on BZX Options is either a member of BZX Options or
a sponsored participant who is authorized to obtain access to the
Exchange's system pursuant to BZX Rule 11.3. See Exchange Rule
1.5(ee) [sic].
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    The Exchange currently charges for logical ports (including
Multicast PITCH Spin Server and GRP ports) $650 per port per month and
$1,500 per month for ports with bulk quoting capabilities. Where a User
subscribes to more than five ports with bulk quoting capabilities, the
Exchange charges for each port in excess of five $2,000 per logical
port per month for logical ports with bulk quoting capabilities.
Logical port fees are limited to logical ports in the Exchange's
primary data center and no logical port fees are assessed for redundant
secondary data center ports. The Exchange assesses the monthly per
logical port fees to all Member's and non-Member's logical ports.
    The Exchange proposes to clarify within its fee schedule how fees
for logical ports may be pro-rated. As proposed, new requests will be
pro-rated for the first month of service. Cancellation requests are
billed in full month increments as firms are required to pay for the
service for the remainder of the month, unless the session is
terminated within the first month of service.
Implementation Date
    The Exchange proposes to implement these amendments to its fee
schedule on August 1, 2016.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6 of the Act.\15\
Specifically, the Exchange believes that the proposed rule change is
consistent with Section 6(b)(4) of the Act,\16\ in that it provides for
the equitable allocation of reasonable dues, fees and other charges
among members and other persons using any facility or system which the
Exchange operates or controls. The Exchange notes that it operates in a
highly competitive market in which market participants can readily
direct order flow to competing venues if they deem fee levels to be
excessive.
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    \15\ 15 U.S.C. 78f.
    \16\ 15 U.S.C. 78f(b)(4).
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    Volume-based rebates such as those currently maintained on the
Exchange have been widely adopted by equities and options exchanges and
are equitable because they are open to all Members on an equal basis
and provide additional benefits or discounts that are reasonably
related to the value to an exchange's market quality associated with
higher levels of market activity, such as higher levels of liquidity
provision and/or growth patterns, and introduction of higher volumes of
orders into the price and volume discovery processes.
Fee Code NP
    The Exchange believes that its proposal to change the standard fee
charged for Customer orders that remove liquidity in Non-Customer Non-
Penny Pilot Securities from $0.99 to $1.07 per contract is reasonable,
fair and equitable because, while the change marks an increase in fees
for orders in Non-Penny Pilot Securities, such

proposed fees remain consistent with pricing previously offered by the
Exchange as well as competitors of the Exchange and does not represent
a significant departure from the Exchange's general pricing
structure.\17\ Additionally, this pricing structure will allow the
Exchange to earn additional revenue that can be used to offset the
addition of new pricing incentives, including those introduced as part
of this proposal. The proposed rate change is also not unfairly
discriminatory because it will apply equally to all Members.
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    \17\ NYSE Arca, Inc. (``NYSE Arca'') charges a fee of $1.08 to
non-customer orders that remove liquidity in Non-Penny Pilot
Securities. See NYSE Arca Options fee schedule available at https://www.nyse.com/publicdocs/nyse/markets/arca-options/NYSE_Arca_Options_Fee_Schedule.pdf. Similarly, the Nasdaq Stock
Market LLC (``Nasdaq'') charges a fee of $1.10 to non-customer
orders that remove liquidity in Non-Penny Pilot Securities. See
Nasdaq Options fee schedule available at http://www.nasdaqtrader.com/Micro.aspx?id=optionsPricing.
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Non-Customer Non-Penny Pilot Take Volume Tier
    The Exchange believes the volume-based discounted rates offered in
the Non-Customer Non-Penny Pilot Take Volume Tiers are reasonable,
fair, equitable and non-discriminatory for the reasons set forth above
with respect to volume-based pricing generally, such changes will apply
equally to all participants, and the change is intended to incentivize
participants to further contribute to market quality on the Exchange.
Moreover, the proposed changes will provide Members with an increased
incentive to interact with orders in Non-Penny Pilot securities on the
Exchange. The Exchange believes this will enhance market quality for
all market participants and encourage increased participation of other
orders wanting to interact with such Non-Customer Non-Penny Pilot
orders, to further the benefit of all market participants.
    The Exchange also believes that the proposed new tiers remain
consistent with pricing previously offered by the Exchange as well as
competitors of the Exchange. The Exchange notes that the criteria
required to achieve proposed Tiers 1, 2, and 3 mirror those required to
achieve the Non-Customer Penny-Pilot Take Volume Tiers 1, 2, and 3
under footnote 3 of the Exchange's fee schedule. Furthermore, the
criteria required to achieve proposed Tier 1, 2, and 3 mirrors that
required by the Customer Add Volume Tier 5, 4, and 6, respectively.
    The Exchange further believes that the criteria necessary to
achieve Tier 1 of the Non-Customer Non-Penny Pilot Take Volume Tier is
reasonable, fair, equitable and non-discriminatory because to the
extent a Member participates on the Exchange but not on BZX Equities
[sic] based on the overall benefit to the Exchange resulting from the
success of BZX Equities. Such success allows the Exchange to continue
to provide and potentially expand its existing incentive programs to
the benefit of all participants on the Exchange, whether they
participate on BZX Equities or not. The proposed pricing program is
also fair and equitable in that membership in BZX Equities is available
to all Members which would provide them with access to the benefits
provided by the proposed tier, as described above, even where a Member
of BZX Equities is not necessarily eligible for the proposed increased
rebates on the Exchange.
QIP Tier
    The Exchange believes that its proposal to eliminate QIP Tier 4
under footnote 5 represents an equitable allocation of reasonable dues,
fees, and other charges among Members and other persons using its
facilities. As described above, the additional rebates offered under
this tier is not affecting Members' behavior in the manner originally
conceived by the Exchange. Additionally, the Exchange currently
provides three other QIP Tiers which offer additional rebates to
qualifying Members adding liquidity. While the Exchange acknowledges
the benefit of Members entering orders which add liquidity, the
Exchange has determined that it is providing additional rebates for
liquidity that would be added regardless of whether the tier existed.
By providing this rebate, the Exchange is not only offering a rebate
for orders that would add liquidity without being incentivized to do
so, but also bypassing the opportunity to offer other rebates or
reduced fees which could incentivize other behavior that would enhance
market quality on the Exchange and benefit all Members. As such, the
Exchange believes the proposed elimination of the QIP Tier 4 would be
non-discriminatory in that it currently applies equally to all Members
and, upon elimination, would no longer be available to any Members.
Further, it will allow the Exchange to explore other ways in which it
may enhance market quality for all Members.
Logical Port Fees
    The Exchange believes that the proposed clarification on how
logical port fees may be pro-rated is consistent with Section 6(b)(4)
of the Act,\18\ in that it provides for the equitable allocation of
reasonable dues, fees and other charges among members and other persons
using any facility or system which the Exchange operates or controls.
The proposed rule change seeks to provide clarity to subscribers
regarding the Exchange's pro-rata billing policy for logical ports by
describing how logical port fees may be pro-rated for a new request and
upon cancellation. The Exchange believes that the proposed pro-rata
billing of fees for logical ports is reasonable in that it is similar
to how port fees are pro-rated by the Nasdaq Stock Market LLC
(``Nasdaq'').\19\
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    \18\ 15 U.S.C. 78f(b)(4).
    \19\ See Nasdaq Price List--Trade Connectivity available at
http://www.nasdaqtrader.com/Trader.aspx?id=PriceListTrading2#connectivity. The Exchange notes
that, unlike as proposed by the Exchange, Nasdaq does not pro-rate
where the session is terminated within the first month of service.
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    The Exchange operates in a highly competitive market in which
exchanges offer connectivity services as a means to facilitate the
trading activities of Members and other participants. Accordingly, fees
charged for connectivity are constrained by the active competition for
the order flow of such participants as well as demand for market data
from the Exchange. If a particular exchange charges excessive fees for
connectivity, affected Members will opt to terminate their connectivity
arrangements with that exchange, and adopt a possible range of
alternative strategies, including routing to the applicable exchange
through another participant or market center or taking that exchange's
data indirectly. Accordingly, an exchange charging excessive fees would
stand to lose not only connectivity revenues, but also revenues
associated with the execution of orders routed to it by affected
members, and, to the extent applicable, market data revenues. The
Exchange believes that this competitive dynamic imposes powerful
restraints on the ability of any exchange to charge unreasonable fees
for connectivity.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange believes the proposed amendments to its fee schedule
would not impose any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. To the contrary,
the Exchange has designed the proposed amendments to its fee schedule
to enhance its ability to compete with other exchanges. Rather, the
proposal as a whole is a competitive

proposal that is seeking to further the growth of the Exchange. The
Exchange has structured certain fees and rebates proposed herein to
attract certain additional volume in both Customer and certain Non-
Customer orders, however, the Exchange believes that its pricing for
all capacities is competitive with that offered by other options
exchanges. Additionally, Members may opt to disfavor the Exchange's
pricing if they believe that alternatives offer them better value.
Accordingly, the Exchange does not believe that the proposed change
will impair the ability of Members or competing venues to maintain
their competitive standing in the financial markets. Additionally,
Members may opt to disfavor the Exchange's pricing if they believe that
alternatives offer them better value. Accordingly, the Exchange does
not believe that the proposed changes to the Exchange's tiered pricing
structure burdens competition, but instead enhances competition by
increasing the competitiveness of the Exchange. The Exchange believes
that the price changes contribute to, rather than burden competition,
as such changes are broadly intended to incentivize participants to
increase their participation on the Exchange, which will increase the
liquidity and market quality on the Exchange and further enhance the
Exchange's ability to compete with other exchanges.
    With regard to the proposed logical port fee amendment, the
Exchange believes that fees for connectivity are constrained by the
robust competition for order flow among exchanges and non-exchange
markets. Further, excessive fees for connectivity, including logical
port fees, would serve to impair an exchange's ability to compete for
order flow rather than burdening competition. The Exchange also does
not believe the proposed rule change would impact intramarket
competition as it would apply to all Members and non-Members equally.

(C) Self-Regulatory Organization's Statement on Comments on the
Proposed Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \20\ and paragraph (f) of Rule 19b-4
thereunder.\21\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
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    \20\ 15 U.S.C. 78s(b)(3)(A).
    \21\ 17 CFR 240.19b-4(f).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BatsBZX-2016-44 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-BatsBZX-2016-44. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing will also be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BatsBZX-2016-44 and should
be submitted on or before September 6, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
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    \22\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-19320 Filed 8-12-16; 8:45 am]
 BILLING CODE 8011-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

	OFFICE OF CHEMICAL SAFETY AND

                   POLLUTION PREVENTION

MEMORANDUM

DATE:		July 26, 2010

SUBJECT:	Isoxaben: Occupational and Residential Exposure Assessment for
the First Food Use on Tree Nuts and Grapes and Non-bearing Fruit and Nut
Trees and Vines.

PC Code: 125851	DP Barcode  Nos.

D374750 (62719-LIN)

D368834 (62719-ARE)

Decision Nos.:

379577  (62719-LIN)

417487 (62719-ARE) 	Registration Nos.

EPA File Symbol: 62719-LIN

(FN-3133 Specialty Herbicide)

EPA File Symbol: 62719-ARE

(Amore™ DF Herbicide)

Petition No.: 7F7222 	Reg. Action: Section 3

Assessment Type:  Occupational              and Residential	Case No.:
7219

TXR No.: NA	CAS No.: 82558-50-7

MRID No.: NA	40 CFR §: 180.xxx  (to be determined)

FROM:		Suku Oonnithan, Biologist

Risk Assessment Branch II

Health Effects Division (7509P)

THROUGH:	Richard A. Loranger, Ph.D., Senior Scientist

Risk Assessment Branch II

Health Effects Division (7509P)

TO:		Kathryn Montague

		Herbicide Branch

		Registration Division (7505P)

I.  ACTION REQUESTED

Perform an occupational and residential exposure (ORE) assessment for
the first food use of isoxaben herbicide in bearing tree nuts and grapes
and non-bearing fruit and nut trees and grape vines.

TABLE OF CONTENTS

  TOC \o "1-2" \u  I.  ACTION REQUESTED	  PAGEREF _Toc267296565 \h  1

II.  EXECUTIVE SUMMARY	  PAGEREF _Toc267296566 \h  3

III.  BACKGROUND	  PAGEREF _Toc267296567 \h  6

IV.  USE PATTERN OF ISOXABEN	  PAGEREF _Toc267296568 \h  6

V.  HAZARD CHARACTERIZATION	  PAGEREF _Toc267296569 \h  7

VI.  RESIDENTIAL AND NON-OCCUPATIONAL EXPOSURES	  PAGEREF _Toc267296570
\h  9

1. Residential Handler Exposure and Risk	  PAGEREF _Toc267296571 \h  10

2. Residential Postapplication Exposures and Risks	  PAGEREF
_Toc267296572 \h  1 1

VII.  OCCUPATIONAL EXPOSURE	  PAGEREF _Toc267296573 \h  1 3

1. Exposure Scenarios, Inputs And Assumptions	  PAGEREF _Toc267296574 \h
 1 3

2.  Occupational Exposures and Risks	  PAGEREF _Toc267296575 \h  1 4

VIII.  OCCUPATIONAL POSTAPPLICATION EXPOSURE	  PAGEREF _Toc267296576 \h
1 5

IX.  SPRAY DRIFT	  PAGEREF _Toc267296577 \h  16

X.  REVIEW OF HUMAN RESEARCH	  PAGEREF _Toc267296578 \h  1 6

XI.  CONCLUSIONS	  PAGEREF _Toc267296579 \h  1 6

XII.  REFERENCES	  PAGEREF _Toc267296580 \h  17

II.  EXECUTIVE SUMMARY

e™ DF Herbicide (EPA File Symbol: 62719-ARE) for use on non-bearing
tree nuts and grape vines.  For isoxaben, this is the first food use
registration.

proposed use pattern: The FN-3133 Specialty Herbicide is being proposed
for broadleaf weed control in bearing tree nuts and grapes and
non-bearing fruit and nut trees and grapes.  The Amore™ DF Herbicide
label is proposed for broadleaf weed control in non-bearing tree nuts
and non-bearing vineyards.  Both formulations have application rates of
0.5-1.0 lb ai/A using low-pressure ground equipment as 1-2 broadcast
sprays per crop year in a minimum spray volume of 10 gal/A.  The maximum
single and yearly application rates are 1.0 lb ai/A.  The preharvest
intervals (PHIs) are 60 and 165 days for tree nuts and grapes,
respectively.

hazard characterization:  Technical isoxaben has low acute oral, dermal,
and inhalation toxicities (Toxicity Categories III-IV).  It is not a
skin irritant (Category IV), but, causes minor irritation to the eye
(Category III).  Isoxaben is not a skin sensitizer.

No treatment related effects were reported in a 21-day repeated dose
dermal toxicity study in the rabbit.  This is consistent with the
relatively low dermal absorption (≤11% of administered dose) observed
in a dermal penetration study in the monkey, and the low toxicity
observed in subchronic oral studies in the rat, mouse and dog.  Due to
the absence of relevant toxic effects, no appropriate endpoints were
identified for short-term incidental oral and dermal risk assessments.
An intermediate-term dermal endpoint also was not selected.  For
intermediate-term incidental oral and inhalation exposures, a no
observed adverse effect level (NOAEL) of 200 mg/kg/day was selected from
a reproductive toxicity study in rat based on decreased body weight gain
in F1 female animals at the lowest observed effect level (LOAEL) of 625
or 1000 mg/kg/day (from co-critical studies).  There was no evidence of
neurotoxicity or immunotoxicity.  There are low concerns for increased
susceptibility of offspring and effects on offspring viability in the
reproductive study, and there was no evidence of susceptibility in
developmental toxicity studies in two species.  Therefore, the 10x FQPA
Safety Factor was reduced to 1x.  The combined uncertainty factor (UF)
of 100 is based on 10X factors for both interspecies extrapolation and
intraspecies variability, serving as the basis for the level of concern
(LOC), which is a margin of exposure (MOE) of 100 for residential and
occupational risks.  Isoxaben was classified as having “suggestive
evidence of carcinogenic potential" based on increased hepatocellular
adenoma incidence in male and female mice.  Because there were no
treatment-related increases in tumors in the rat and low concerns for
genotoxicity, quantification of cancer risk using a cancer potency
factor is not required.

residential and non-occupational exposures:  No new residential uses for
isoxaben were included with the proposed new product applications.
However, several EPs have been registered for weed control on
residential lawns and recreational turf areas.  For assessing
residential handler exposures, two representative products, an
emulsifiable concentrate (EC) and a granule, were selected based on
maximum single application rates on residential lawns and turf areas.
Both the EC and granular products could be applied by homeowners twice a
year with the maximum rate per application being 0.49 and 1.0 lb ai/A,
respectively.  The intervals between treatments are 56-60 days resulting
in residential applicators being subjected to short-term exposures.  The
short-term dermal risks to homeowners were not estimated due to the lack
of an  endpoint.  The short-term inhalation MOEs ranged from 2.9E+06 to
2.8E+07 with an LOC of 100, indicating the risks are not of concern for
residential handlers when using the EC and/or granule formulations of
isoxaben on home lawns.

residential postapplication exposures: There is a potential for
postapplication dermal,

inhalation and oral (children only) exposures of isoxaben to adults and
children when they work and/or play on treated lawn areas.  The
short-term dermal and incidental oral (children) exposures were not
estimated due to the lack of respective endpoints.  The short-term
inhalation exposure is expected to be negligible because of soil
directed applications of EC and granules and because of the label
recommendation for incorporation by irrigation or rain soon after
application.

However, there is a potential for intermediate-term oral exposure to
children through soil ingestion due to the second application of
isoxaben granules at 56 days after the first treatment, and because of
the potential for higher persistence of isoxaben in soil.  Usually HED
does not assess such intermediate-term postapplication exposures under
residential conditions, except on a case-by-case basis.  Due to the
persistence of isoxaben in the soil, HED decided to assess children's’
exposure from ingesting soil when turf is treated with isoxaben at the
maximum yearly rate.  The residential-use product selected for this
assessment was Isoxaben 75 DF where  maximum single and yearly
application rates are 1.0 and 3.0 lb ai/A.  HED assumed that incidental
ingestion of soil represents the worst case for oral postapplication
exposure, since no other oral scenarios would be expected to have an
equivalent duration of exposure to residues as high as those possible in
soil.  The MOE associated with soil ingestion is 1,300,000 with an LOC
of 100, and therefore is not of concern.  This scenario is expected to
be protective of all other postapplication risks for children in
residential settings.

were ≥ 2,700 with an LOC of 100 and are not of concern.

occupational postapplication exposure:  Only one application of isoxaben
is allowed per season at the maximum rate per application (two at lower
rates) on tree nuts, grapes and non-bearing fruit and nut trees.
Postapplication workers who enter treated fields after the restricted
entry interval (REI) of 12 hours are subjected to only short-term dermal
and inhalation exposures and such risks to workers are not of concern
because of the soil-directed application method proposed for applying
isoxaben formulations, thereby minimizing inhalation exposure, and due
to the lack of a dermal endpoint.  The labels also recommend
incorporation of the spray by rainfall or irrigation for maximum
efficacy as a preemergence herbicide, thereby further minimizing
postapplication exposure.

conclusions:  The potential risks to occupational workers who apply
FN-3133 Specialty Herbicide and Amore™ DF Herbicide formulations of
isoxaben to bearing tree nuts and grapes and nonbearing fruit and nut
tress and grape vines are below HED's level of concern.  Potential risks
to homeowners from applying isoxaben formulations registered for
residential use on home lawns and to adults and children from
postapplication exposures are also not of concern.  Therefore, pending
the results of an aggregate human health risk assessment, HED has no
objection to registering the proposed new formulations of isoxaben for
the proposed uses, which include the first food use for isoxaben.

III.  BACKGROUND

Amore™ DF Herbicide (EPA File Symbol: 62719-ARE) containing isoxaben
(75%) and penoxsulam (3.12%) is proposed for use on non-bearing tree
nuts and non-bearing vines. This assessment addresses only isoxaben and
its occupational and residential exposures.  For penoxsulam, tolerances
have been established (40 CFR §180.605) for residues in almond, grape,
pistachio and rice and the occupational and residential exposures were
reviewed in conjunction with the aggregate risk assessment for
penoxsulam.

Isoxaben is a benzamide herbicide with broad spectrum preemergence
activity against broadleaf weeds.  It is currently registered for use on
ornamentals, home lawns, turf, and Christmas tree and conifer
plantations.  The registered formulations include dry flowable (DF),
ready-to-use (RTU), emulsifiable concentrate (EC) and granule mixed with
fertilizers.  Both FN-3133 Specialty Herbicide and Amore™ DF are dry
flowable formulations.

IV.  USE PATTERN OF ISOXABEN

Both products are being registered for control of certain broadleaf
weeds in bearing and/or non-bearing fruit and nut tree orchards and
grapes.  The proposed use pattern for isoxaben is provided in the
following table (Table 1).

Table 1.  Proposed Use Patterns of FN-3133 (File Symbol: 62719-LIN) and
Amore™ DF (File Symbol:  62719-ARE) Formulations of Isoxaben.

EPA File Symbol & Active Ingredients 	Use
     sites 	Application           equipment	Application
       rates	No. appls./ season & interval 1

Comments

62719-LIN

(FN-3133)

Isoxaben 75%

Low pressure ground sprayers,  spray volume   ≥ 10 gal/A	Single =
0.66-1.33 lb product/A

Max. single rate = 1.0 lb ai/A)

Max. seasonal rate = 1.0 lb ai/A	1-2 per  crop year, (harvest to
harvest)	PHI = 60 days for tree nuts and 165 days for grapes

62719-ARE

(Amore™ DF)

Isoxaben = 75.0% plus                Penoxsulam = 3.12%  (DF
formulation) 	Non-bearing tree nuts and non-bearing grape vines

Single = 1.0-1.33 lbs product/A

Max. single rate =1.0 lb ai/A)

Max. seasonal rate  = 1.0 lb ai/A	1 per season	NA

Abbreviations used: DF = dry flowable, NA = not applicable and PHI =
preharvest interval.

1. No spray interval was given in the submitted draft label.

The FN-3133 Specialty Herbicide is proposed for preemergence control of
broadleaf weeds in tree nuts, grapes, and non-bearing fruit and nut
trees and non-bearing grape vines.  The non-bearing trees are those that
will not bear fruit for at least one year after treatment.

Labels of both products recommend use of ground application equipment
including ground boom and low pressure handwand to spray the base of
trees and vines to avoid crop injury.  Activation of the applied spray
by rain or irrigation for optimum weed control is recommended.  Tank
mixes with both formulations are allowed; however, chemigation or
application by any type of irrigation system is prohibited.

The submitted draft labels of both products have CAUTION as Signal Word.
 The personal protective equipment (PPE) statement on FN-3133 Specialty
Herbicide includes long sleeved shirt, long pants, shoes plus socks and
chemical resistant gloves; for Amore™ DF, the PPE statement includes
only long sleeved shirt, long pants and shoes plus socks.  Both product
labels have 12 hour restricted entry intervals (REIs) per the worker
protection standard (WPS).

V.  HAZARD CHARACTERIZATION

Technical isoxaben has low to moderate acute toxicities by oral, dermal,
and inhalation routes (Toxicity Categories III-IV).  It is not a skin
irritant (Category IV) or a dermal sensitizer and causes only minor
transient irritation to the eye (Category III).  The acute toxicity
profile of isoxaben is summarized in Table 2.

 Table 2. Acute Toxicity Profile – Isoxaben

Guideline No.	Study Type	Results	Toxicity Category

870.1100	Acute oral – rat	LD50 > 10,000 mg/kg (both sexes)	IV

870.1200	Acute dermal - rabbit	LD50 > 2000 mg/kg (both sexes)	III

870.1300	Acute inhalation - rat	LC50 > 1.99 mg/L (both sexes)	III

870.2400	Acute eye irritation - rabbit	Irritation to the cornea and iris
cleared within 24 hrs	III

870.2500	Acute dermal irritation - rabbit	Non-irritating	IV

870.2600	Skin sensitization - guinea pig	Not a sensitizer (Buehler
method)	N/A

The primary target organs for the toxicity of isoxaben are the liver and
kidney.  No treatment related effects were reported in a 21-day repeated
dose dermal toxicity study in the rabbit.  This is consistent with
relatively low dermal absorption (≤11% of administered dose) observed
in a dermal penetration study in the monkey and the low toxicity
observed in sub-chronic oral studies in the rat, mouse and dog.  No
appropriate points of departure (PODs) or endpoints were selected for
short-term incidental oral and short-and intermediate-term dermal
exposure routes due to the absence of adverse effects.  For the
intermediate-term incidental oral and short- and intermediate-term
inhalation exposures, a NOAEL of 200 mg/kg/day was selected from the rat
reproductive toxicity study based on decreased body weight gain in F1
females observed at the LOAEL of 625 or 1000 mg/kg/day (co-critical
studies).  There was no evidence of neurotoxicity or immunotoxicity.
There are low concerns for increased quantitative susceptibility of
offspring and effects on offspring viability in the reproductive
toxicity study, and there was no evidence of susceptibility in
developmental toxicity studies in two species.  Therefore, the 10x FQPA
Safety Factor was reduced to 1x.  A combined UF of 100 is based on 10X
factors for both interspecies extrapolation and intraspecies
variability, serving as the basis for the level of concern (LOC), which
is a margin of exposure (MOE) of 100 for residential and occupational
risks.   HED notes that a 60 kg body weight was assumed for residential
and occupational handlers in order to be protective of the offspring
effects seen in the reproduction toxicity study.

Isoxaben was classified as having “suggestive evidence of carcinogenic
potential" based on increased hepatocellular adenoma incidence in male
and female mice. Because there were no treatment-related increases in
tumors in the rat and low concerns for genotoxicity, quantification of
cancer risk with a cancer potency factor is not required.

Based on the available toxicity data and HED’s current practices, the
short- and intermediate-term inhalation risks for isoxaben were assessed
using an oral toxicity study.  However, HED is in the process of
re-examining policies and procedures for conducting inhalation risk
assessments, including route to route extrapolation of toxicity data.
If any new policies or procedures are developed, HED may revisit the
need for an inhalation toxicity study for isoxaben.  Endpoints and doses
selected for the occupational and residential risk assessment of
isoxaben are summarized in Table 3.  A detailed discussion of isoxaben's
hazard assessment is available in the latest risk assessment (D.
McNeilly, D376428, 2010).

Table 3.  Toxicological Doses and Endpoints of Isoxaben Selected for
Occupational and Residential Risk Assessments.

Exposure Scenario 1	Point of Departure	Uncertainty & FQPA Safety Factors
Level of Concern	Study and Toxicological Effects

Acute dietary,  General population, including children	An appropriate
endpoint to assess exposure for this route and duration was not
identified.

Incidental oral, Short-term 	An appropriate endpoint to assess exposure
for this route and duration was not identified.

Incidental oral, Interm.-term                  	NOAEL=200 mg/kg/day
           	UFA =10x

UFH =10x              FQPA SF = 1x           	Residential LOC for MOE =
100

	Reproductive toxicity in the rat (oral).

Offspring LOAEL = 1,000 mg/kg/day, based on decreased body weight gain
in F1 females on Day 70.

One year dietary study in the rat (co-critical supporting study).

LOAEL = 625 mg/kg/day based on decreased body weight gain in females
during the first six months with a NOAEL of 62.5 mg/kg/day.

Dermal, Short- and Interm.-term 	An appropriate endpoint to assess
exposure for this route and duration was not identified.

Inhalation,          Short-term            	NOAEL=200 mg/kg/day
     Inhalation absorption                rate = 100%
      	UFA =10x

UFH =10x              FQPA SF = 1x              	Residential/

Occupational LOC for MOE = 100	Reproductive toxicity in the rat (oral).

Offspring LOAEL = 1,000 mg/kg/day, based on decreased F2 pup weights,
gestation survival and live pups/litter and increased incidence of
malformations.

Inhalation, Interm.-term 	NOAEL=200 mg/kg/day               Inhalation
absorption                rate = 100%                          	UFA =10x

UFH =10x              FQPA SF = 1x              	Residential LOC for MOE
= 100

Occupational LOC for MOE = 100	Reproductive toxicity in the rat (oral).

Offspring LOAEL = 1,000 mg/kg/day, based on decreased F2 pup weights,
gestation survival and live pups/litter and increased incidence of
malformations.

One year dietary study in the rat (co-critical supporting study).

LOAEL = 625 mg/kg/day based on decreased body weight gain in females
during the first six months with a NOAEL of 62.5 mg/kg/day.

Cancer (oral, dermal, inhalation)	Classified as having “suggestive
evidence of carcinogenic potential” based on increased incidence of
hepatocellular adenomas in male and female mice.  A quantitative cancer
risk assessment with a cancer potency factor is not required because
there were no treatment-related increases in tumors in the rat and low
concerns for genotoxicity.

Abbreviations used: FQPA SF = Food Quality Protection Act Safety Factor,
LOAEL = lowest observed adverse effect level, NOAEL = no observed
adverse effect level, LOC = level of concern, MOE = margin of exposure,
UFA = extrapolation from animal to human, and UFH = potential variation
in sensitivity among human population.

1. Short-term is 1-30 days and intermediate-term is 1-6 months duration.

VI.  RESIDENTIAL AND NON-OCCUPATIONAL EXPOSURES

There are several registered liquid and solid end-use product
formulations available for weed control on home lawns, recreational turf
areas and ornamental plantings.  Some products are labeled for use by
homeowners and others are for use by professional applicators.  No new
residential uses for isoxaben are being requested with this application.

Even though isoxaben is already registered for weed control in
residential areas, quantitative homeowner (handler) and postapplication
exposure assessments were not previously conducted due to the lack of
short-term incidental oral, dermal and inhalation endpoints needed to
estimate these risks.  Based on the current hazard characterization and
in order to complete an aggregate risk assessment in conjunction with
the proposed first food use of isoxaben, residential exposures were
estimated, taking into consideration all end-use products registered for
residential uses.

For assessing residential handler exposure, two representative product
formulations having the highest single application rates were selected.
They are an EC (Lawn 3iP Herbicide Concentrate, Reg. No. 72155-87) and a
granule (T&O Fertilizer-Contains Gallery plus Team, EPA Reg. No.
62719-280).  The liquid and granule have maximum single application
rates of 0.49 and 1.0 lb ai/A, respectively.  The granule product is
packaged and marketed individually as homeowner and commercial products
and both labels have almost identical use patterns (Table 4).

Table 4.  Use Pattern of Isoxaben End-use Products Selected for
Residential Handler and Postapplication Exposure Assessments.

EPA              Reg. No.1	Application
   Equipment 	Appl. rates	No. appls./ season & interval 2

Comments

Lawn 3iP Herbicide Conc., Reg. No. 72155-87

(EC, Isoxaben = 2.63%)	Homeowner/Commercial Label

After mixing with water

- pump style hand held sprayer

- concentrate plus water hose-end sprayer

Without mixing with water

 - dial-style hose-end sprayer

- single-rate or dual- rate hose-end sprayer	Rate/appl.= 1.6-3.2 fl. oz.
/500 sq. ft

Max/appl.= 0.49 lb ai/A

Max/year = 0.98 lb ai/A

	2/year

60 days	NA

T&O Fertilizer, EPA Reg. No. 62719-280 (Granule) Isoxaben = 0.38%)
Homeowner/Commercial Label

- drop or rotary-type granule spreader  	Rate/appl.= 174-265 lbs/A

Max/appl.= 1.0 lb ai/A

Max/year = 2.0 lb ai/A 	2-7/year

56 days 	Sprinkler  irrigation or rainfall within a few hours is
recommended

Isoxaben 75DF Specialty Herbicide

EPA Reg. No. 34704-917, DF

Isoxaben=75%	Commercial Label

- herbicide sprayer

 ≥10 gal/A

	Rate/appl.= 0.66-1.33 lbs/A

Max/appl.= 1.0 lb ai/A

Max/year = 4 lbs/A (3.0 lb ai/A)	3 or more

60 days 	Sprinkler  irrigation or rainfall after application is
recommended

Abbreviations used: DF = dry flowable, EC = emulsifiable concentrate, NA
= not applicable

1. Lawn 3iP Herbicide Concentrate/Ready-to-Spray (Reg. No. 72155-87) is
an EC containing isoxaben (2.63%), 2,4-D dimethylamine salt (4.73%),
dicamba (0.52%) and mecoprop-p potassium salt (1.1%). T&O
Fertilizer-Contains Gallery plus Team (EPA Reg. No. 62719-280) is a
granule + fertilizer containing isoxaben (0.38%), trifluralin (0.39%)
and benefin (0.76%).

2. Repeat applications may represent rates that are lower than the
maximum single rate/A.

1. Residential Handler Exposure and Risk

The use patterns used for a quantitative assessment of homeowner
exposures are from EC and  granule products (Table 4).

Potential Exposure Scenarios: The following scenarios were assessed:

1. mixing/loading/applying EC using a hose-end sprayer

2. mixing/loading/applying EC using a hand-held pump sprayer

3. loading/applying granules using a granular push-type spreader

Application Rate and Exposure Durations:  For residential handler
exposure assessment, HED uses maximum single application rates and
frequency of treatments for determining short- and intermediate-term
exposures.   The EC product label recommends two applications per year
for weed control on home lawns at a single maximum rate of 0.49 lb ai/A.
 The minimum interval between treatments is 60 days.  Therefore,
homeowners are exposed to only short-term dermal and inhalation risks.
The granule product label recommends repeat applications at an interval
of 56 days on cool season grass and 70 days on warm season grass at a
single maximum single rate of 0.99 lb ai/A, resulting in short-term
exposures.  There are some distributor products sold in Florida (both
homeowner and commercial labels) that recommend up to 7 applications per
year on Bermuda grass with a maximum rate of 2 lb ai/A/year.  These
repeated applications are assumed to be made at an average rate of 0.3
lb ai/A/application taking into account an annual limit of 2.0 lb ai/A.
Despite the potential for repeated applications, HED continues to
consider residential handler exposures to be short-term in duration
based on the minimum 56 day retreatment interval.

Exposure and Risk to Residential Handlers:  No chemical specific
exposure data have been submitted by the registrant to estimate the
inhalation unit exposures for residential handlers.  Therefore,
surrogate unit exposures from the Outdoor Residential Exposure Task
Force database (ORETF) were selected.  Short-term dermal risks were not
estimated due to the lack of a dermal endpoint.  The short-term
inhalation MOEs ranged from 2.9E+06 to 2.8E+07 (LOC=100) and are not of
concern (Table 5).

Table 5.  Exposures and Risks for Residential Handlers Applying Liquid
and Granule Formulations of Isoxaben on Residential Lawns. 1

Exposure             Scenarios	Max. Single Appl. rate,             lb
ai/Acre 2	Area treated Acres/day 3 	Inhal. UE mg/lb ai

(ORETF)	Inhal. dose mg/kg/day 4	Short-term Inhal.                 MOE 5

M/L/A, liquid,

hose-end sprayer	0.49	0.5	0.017	6.94E-05	2.9E+06

M/L/A, liquid,

hand-held sprayer	0.49	0.5 	0.0038	1.55E-05	1.3E+07

L/A, granules,

push-type spreader	0.99	0.5	0.00088	7.2E-06	2.8E+07

Abbreviations used: A= applicator, L= loader, ORETF = Outdoor
Residential Exposure Task Force, and UE= unit exposure.

1. Short-term dermal exposures were not estimated due to the absence of
a dermal endpoint.

2.  The maximum single application rate is from Table 5.

3.  The area treated is assumed to be 0.5 A for hose-end and hand-held
sprayers (based on a standard rate of 10 gal of spray/A) and 0.5 acres
for granules.

4.  Inhalation dose (mg/kg/day) = (application rate * area treated/day *
inhalation unit exposure * inhalation absorption rate) / body wt. (60
kg).

5. Inhalation MOE = Short-term Inhalation NOAEL (200 mg/kg/day) /
inhalation dose.

2. Residential Postapplication Exposures and Risks

For evaluating the residential postapplication exposure of isoxaben, EC,
granule and solid formulations were considered (Table 4).  Since the
Isoxaben 75 DF Specialty Herbicide, EPA Reg. No. 34704-917, had the
highest application rate/year, it was assumed that the estimated risks
would be protective of those associated with other formulations and
application rates.  This solid formulation is labeled for use by
professional applicators on established turf, landscape, container and
field grown ornamentals, non-cropland, non-bearing fruit and nut trees
and non-bearing vineyards.  It has a maximum single application rate of
1.0 lb ai/A (similar to EC and granule), with a yearly rate of 3.0 lb
ai/A.

Dermal Exposures to Children, Youth and Adults:  Dermal endpoints were
not selected for isoxaben, for any duration of exposure, due to the lack
of toxic effects via the dermal route; therefore, there is no risk of
concern associated with dermal postapplication exposure.

Short-Term Incidental Oral Exposures to Children from Hand-to-Mouth and
Object-to-Mouth Events:  It is likely that children playing in treated
turf areas would ingest residues of isoxaben from hand-to-mouth and
objects-to-mouth events.  However, there is no endpoint applicable to
short-term oral exposure, and therefore, there are no risks of concern
associated with hand-to-mouth and object-to-mouth exposure.

Episodic Oral Exposures to Children from Ingestion of Granules:
Ingestion of isoxaben granules following application of T&O
Fertilizer-Contains Gallery plus Team to turf is considered to be an
episodic event for children playing on treated lawns.  The granules are
not likely to be present on treated turf for up to 30 days (i.e.,
short-term durations) due to the label recommendation for
irrigation/watering within hours of application.  Further, in the
absence of an acute dietary endpoint attributable to a single exposure,
episodic ingestion of granules was not assessed.

Bystander Inhalation Exposure:  Based on the Agency's current practices,
residential postapplication inhalation risk to children is not assessed;
however, bystander exposure could occur for children playing in areas
adjacent to pesticide applications.  For adult bystanders,
postapplication inhalation exposure is expected to be negligible because
(i) technical isoxaben has low inhalation toxicity (Category III); (ii)
label recommended incorporation by rainfall or irrigation after
application; (iii) isoxaben has low volatility (vapor pressure 1.3E-8 Pa
at 25˚ C, McNeilly 2010); and (iv) products are not applied using
airblast or aerial equipment that would result in significant inhalation
exposure.  However, volatilization of pesticides may be a potential
source of postapplication inhalation exposure to individuals nearby to
pesticide applications.  The Agency sought expert advice and input on
issues related to volatilization of pesticides from its Federal
Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel
(SAP) in December 2009.  The Agency received the SAP’s final report on
March 2, 2010 (http://www.epa.gov/scipoly/SAP/meetings
/2009/120109meeting.html).  The Agency is in the process of evaluating
the SAP report and may, as appropriate, develop policies and procedures
to identify the need for and, subsequently, the way to incorporate
postapplication inhalation exposure into the Agency's risk assessments.
If new policies or procedures are put into place, the Agency may revisit
the need for a quantitative postapplication inhalation exposure
assessment for isoxaben.

Intermediate-term Incidental Oral Exposure to Children resulting from
Soil Ingestion:   HED does not typically consider soil ingestion to
occur over intermediate-term durations, i.e., from 1-6 months, largely
due to use pattern and the fact that residues are removed by
precipitation or through microbial degradation in soil.  In the case of
isoxaben, HED estimated incidental oral exposure from ingestion of soil
because the use pattern calls for repeat applications, and because the
environmental fate data indicated that isoxaben is persistent in the
soil, with a half life of ≥150 days (C. Peck., D341497, 3/18/2010).
Because of the likely persistence of isoxaben in  soil, HED conducted a
conservative assessment of potential intermediate-term oral risk from
soil ingestion by using an yearly application rate of 3.0 lb ai/A from
Isoxaben 75 DF instead of the maximum single rate of 1.0 lb ai/A.

To address the persistence of isoxaben in the soil, HED assumed that
exposure resulting from incidental oral ingestion of soil
(intermediate-term) at an exaggerated rate of 3.0 lb ai/A/year would be
a conservative estimate that would address the likely potential build up
of isoxaben in the soil.  The exposure and risk from incidental oral
ingestion of soil was calculated using the following formula:

ADD = (SR * IgR2 * CF4) / BW where, SR = AR * F3 * CF1 * CF2 * CF3

MOE = NOAEL / ADD

SR  = 3.0 lb ai/A * 100%/cm * 4.54E+08 µg/lb * 2.47E-08 A/cm2  * 0.67
cm3 /g soil = 22.54 µg ai/g

ADD = [22.54 µg ai/g  * 100 mg/day * 0.000001 g/µg] / 15 kg = 1.50E-04
mg/kg/day

MOE = 200 mg/kg/day / 1.50E-04 mg kg/day = 1.30E+06

where,

ADD  = Average daily dose (mg/kg/day)

AR = Application rate (3.0 lb ai/A/year)

BW =  Body weight of child (15 kg)

CF1 = Conversion factor for µ/lb (4.54E+08)

CF2 = Conversion factor for A/cm2  (2.47E-08)

CF3 = conversion factor for volume to weight (0.67 cm3 /g soil)

CF4 = conversion factor for g/µg (0.000001)

F3 = Percent of ai available in uppermost cm of soil (100% assumed)

IgR2 = Ingestion rate of soil (100 mg/day)

MOE = NOAEL (intermediate-term, mg/kg/day) / ADD (mg/kg/day)

NOAEL (intermediate.-term) = 200 mg/kg/day

SR = Soil residue at intermediate-term (µg ai/g soil)

t = postapplication day on which exposure is assessed
(intermediate-term)

It is emphasized here that the application rate of 3.0 lb ai/A/year used
for estimating the intermediate-term exposure is an exaggerated rate
when compared with the single application rate of 1.0 lb ai/A of granule
and DF formulations.  At the intermediate-term exposure duration, the
risk was found to be not of concern to children who may ingest soil
treated with isoxaben (MOE = 1.30E+06, LOC =100).

VII.  OCCUPATIONAL EXPOSURE

1. Exposure Scenarios, Inputs and Assumptions

Both isoxaben products (FN-3133 Specialty Herbicide and Amore™ DF) are
DF formulations and have identical application rates and methods.
Therefore, both products have similar exposure scenarios as shown below:

1. mixing and loading of DF formulation for ground boom spray

2. applying the diluted spray using tractor mounted ground boom spray
equipment

3. mixing, loading and applying DF formulation using a tractor mounted
low-pressure handwand sprayer to treat areas not covered by boom
sprayer.

The inputs and assumptions used for estimating the exposures to handlers
are the following:

1.  Application rate:  The maximum single application rate for isoxaben
is 1.0 lb ai/A for bearing or non-bearing trees and grape vines.

2.  Unit exposures:  No chemical specific exposure data are available to
estimate inhalation unit exposures for handlers.  Therefore, surrogate
unit exposures were selected from PHED, based on the formulation type,
application equipment and PPE.  In PHED, there are no inhalation unit
exposures for a M/L/A scenario for a solid DF formulation using a
low-pressure handwand sprayer.  Therefore, unit exposures for the
wettable powder (WP) formulation were used. Since the WP is dustier than
the DF, the resulting exposure estimates are expected to be conservative
for assessing exposure from the DF formulation.

3.  Area treated/8-hr day:  ExpoSAC Policy No. 9 estimates that 40-200
acres can be treated/day with a tractor mounted ground boom sprayer
depending upon the crop treated.  For this  assessment, 80 A/day was
selected for the orchard setting based on treatment of orchard trees
planted in rows.  Areas not covered with a ground-boom sprayer (corners
and edges of orchards) or spot treatments may be made using a tractor
mounted low-pressure handwand sprayer.  It is assumed that a handler
(M/L/A) can mix, load and apply 40 gal/day (ExpoSAC Policy No. 9); at
the label recommended spray volume of 10 gal/A, HED estimates 4
acres/day could be treated for the tractor mounted low-pressure handwand
scenario.

4.  Personal Protective Equipment (PPE):  Baseline PPE (long sleeved
shirt, long pants and shoes with socks) was used as a starting point to
calculate handler exposures.  For the present assessment additional
protection (e.g., respirators; engineering controls (enclosed cab and
cockpit, closed systems)) was not needed to obtain an MOE that is higher
than the LOC.

5.  Duration of exposure:  The label allows only 1 application of
FN-3133 at the maximum single rate of 1.0 lb ai/A  (harvest to harvest)
on tree nuts, grape, and non-bearing fruit tree and grapevine orchards,
resulting in short-term exposure to occupational handlers.  However, it
is possible that contract applicators may use FN-3133 Herbicide on
several fields, with sequential applications lasting longer than a month
during the weed growing season, resulting in intermediate-term exposure
to handlers.

and Amore™ DF Herbicide in orchards of bearing and non-bearing fruit
and nut trees and grape vines.

Table 6.  Short- and Intermediate-term Exposures Resulting from the Use
of FN-3133 Specialty Herbicide and Amore™ DF Herbicide in Orchards of
Bearing and Non-bearing Fruit and Nut Trees and Grape Vines 1.

Exposure Scenario	Appl.  rate	Area treated (A/day) 	PPE & Eng. Control 2
Inhal. unit exposure                       (mg/lb ai) 3	Inhalation,
Short– and Intermediate-term

	Exposure

mg/kg/day  4	MOE 5

1. Mixing/loading DF for ground boom spray (open mixing)	1.0 lb al/A

	80

 	Baseline	0.00077	0.00103	190,000

2. Applying spray using ground boom

	Baseline & open cab.	0.00074	0.00099	200,000

3. Mixing, loading, and applying using a tractor powered low-pressure
hand wand

4

 	Baseline 	1.1	0.07333	2,700

1.  MOE = Margin of exposure and PPE = Personal protective equipment.
The inputs used for calculations are explained under Exposure Scenarios,
Inputs and Assumptions.

2. Baseline PPE includes long sleeved shirt, long pants and shoes with
socks.  Engineering controls include open cab (tractor) for applicators.

3. Lacking unit exposures in PHED for a DF formulation, unit exposures
for mixing, loading and applying a wettable powder formulation with a
low-pressure handwand were used as surrogate.

4. Inhalation exposure = [Inhalation unit exposure (mg/lb ai) * appl.
rate (lb ai/A) * area treated/day (acres) * inhalation absorption 100 %]
/ body wt (60 kg).

5. MOE = Short- and intermediate-term NOAEL (200 mg/kg/day) /inhalation
exposure (mg/kg/day)

Dermal exposure was not assessed due to the lack of dermal endpoints.
The short- and intermediate-term inhalation MOEs for handlers ranged
from 2,700 to 200,000 which are not of concern.

VIII.  OCCUPATIONAL POSTAPPLICATION EXPOSURE

Workers entering treated areas to do crop related cultural practices
such as irrigation, scouting, pruning, etc., may be exposed to isoxaben
residues via dermal and inhalation routes for short-term durations.
However, postapplication dermal risk for workers is not of concern
because of the absence of a short-term dermal endpoint.

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ency sought expert advice and input on issues related to volatilization
of pesticides from its Federal Insecticide, Fungicide, and Rodenticide
Act Scientific Advisory Panel (SAP) in December 2009.  The Agency
received the SAP’s final report on March 2, 2010
(http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html).  The
Agency is in the process of evaluating the SAP report as well as
available postapplication inhalation exposure data generated by the
Agricultural Reentry Task Force and may, as appropriate, develop
policies and procedures, to identify the need for and, subsequently, the
way to incorporate occupational postapplication inhalation exposure into
the Agency's risk assessments.  If new policies or procedures are put
into place, the Agency may revisit the need for a quantitative
occupational postapplication inhalation exposure assessment for
isoxaben.

Restricted Entry Interval (REI):  A 12-hour REI was set for isoxaben
based on the acute toxicity properties of the technical material which
is classified as Categories III (acute dermal, inhalation and eye
irritation) and IV (acute oral and skin irritation).  Isoxaben is not a
dermal sensitizer.  The 12-hour REI is appropriate for isoxaben based on
the WPS for agricultural pesticides.

IX. SPRAY DRIFT

Spray drift is always a potential source of exposure to residents near
to pesticide spraying operations.  This is particularly the case with
aerial applications, but, to a lesser extent, could also be a potential
source of exposure from the ground application methods employed for
isoxaben.  The Agency has been working with the Spray Drift Task Force,
EPA Regional Offices and State Lead Agencies for pesticide regulation
and other parties to develop the best spray drift management practices.
On a chemical by chemical basis, the Agency is now requiring for aerial
applications, interim mitigation measures that must be placed on product
labels.  The Agency has completed its evaluation of the new database
submitted by the Spray Drift Task Force, a membership of U.S. pesticide
registrants, and is developing a policy on how to appropriately apply
the data and the AgDrift computer model to its risk assessments for
pesticides applied by air, orchard air blast and ground hydraulic
methods.  After the policy is in place, the Agency may impose further
refinements in spray drift management practices to reduce off-target
drift with specific products with significant risks associated with
drift.

X.  REVIEW OF HUMAN RESEARCH

This risk assessment relies in part on data from studies in which adult
human subjects were intentionally exposed to determine their dermal and
inhalation exposures.  Many such studies, involving exposure to many
different pesticides, comprise generic pesticide exposure databases,
such as Pesticide Handlers Exposure Database (PHED), the Outdoor
Residential Exposure Task Force (ORETF) database and the Agricultural
Reentry Task Force (ARTF) database.  EPA has reviewed all the studies in
these multi-pesticide generic exposure databases, and on the basis of
available evidence has found them to have been neither fundamentally
unethical nor significantly deficient relative to standards of ethical
research conduct prevailing when they were conducted.  There is no
regulatory barrier to continued reliance on these studies, and all
applicable requirements of EPA's Rule for the Protection of Human
Subjects for Research (40 CFR part 26) have been satisfied.

XI.  CONCLUSIONS

1.	The potential risks to occupational handlers who apply DF
formulations of isoxaben (FN-3133 Specialty Herbicide and Amore™ DF
Herbicide) to bearing tree nuts and grapes and non-bearing fruit and nut
trees and grapes are below HED's LOC.

2.	The registrant did not propose new residential uses for isoxaben with
these submissions.  However, there are existing uses for isoxaben in
residential settings resulting in exposure to homeowners.  Residential
handler exposure was estimated for a granule formulation of isoxaben
applied at 1.0 lb ai/A or an EC formulation applied at 0.5 lb ai/A on
residential turf grasses.  Both these scenarios resulted in risks for
residential handlers which are not of concern.

3. 	The short-term postapplication risks to adults and children from
dermal and incidental oral exposures of isoxaben were not assessed due
to the lack of respective endpoints.  There is a potential for
intermediate-term oral postapplication exposure to children through
ingestion of soil while playing on treated lawns.  HED conservatively
estimated the risk from soil ingestion due to the potential for isoxaben
to persist in soil following application to turf.  A conservative
estimate of children’s exposure and risk from soil ingestion
demonstrated that the risk is not of concern, with an MOE of 1.30E+06.

4.	Pending the results of an aggregate human health risk assessment, HED
has no objection to registering the proposed new uses, including the
first food use for isoxaben.  The submitted worker protection statements
on both draft labels are adequate to protect occupational handlers and
postapplication workers.

XII.  REFERENCES

McNeilly, D.  D376428, 2010.  Isoxaben.  Human Health Risk Assessment
for the First Food Uses of the Herbicide on Grapes, Tree Nuts and
Pistachios.

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New Use on Bearing Nut Trees and Vineyards.

Page   PAGE  1  of   NUMPAGES  17

Page   PAGE  18  of   NUMPAGES  18


[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Rules and Regulations]
[Pages 76381-76383]
[FR Doc No: 2015-30973]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-3783; Directorate Identifier 2015-SW-027-AD;
Amendment 39-18342; AD 2015-25-04]
RIN 2120-AA64

Airworthiness Directives; Agusta S.p.A. Helicopters

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

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for Agusta
S.p.A. (Agusta) Model A109A and A109A II helicopters. This AD requires
inspecting the slider assembly pitch control (slider) for play and
replacing the slider if the play exceeds certain limits. This AD is
prompted by a report of excessive slider play and wear that was
detected during a scheduled inspection of a Model A109A II helicopter.
These actions are intended to detect and prevent excessive wear and
play on a slider, which could lead to loss of tail rotor pitch control
and consequently loss of helicopter control.

DATES: This AD becomes effective December 24, 2015.
    We must receive comments on this AD by February 8, 2016.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
3783; or in person at the Docket Operations Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the European Aviation Safety Agency (EASA) AD, the
economic evaluation, any comments received, and other information. The
street address for the Docket Operations Office (telephone 800-647-
5527) is in the ADDRESSES section. Comments will be available in the AD
docket shortly after receipt.
    For service information identified in this AD, contact
AgustaWestland, Product Support Engineering, Via del Gregge, 100, 21015
Lonate Pozzolo (VA) Italy, ATTN: Maurizio D'Angelo; telephone 39-0331-
664757; fax 39-0331-664680; or at http://www.agustawestland.com/technical-bulletins. You may review the referenced service information
at the FAA, Office of the Regional Counsel, Southwest Region, Room 6N-
321, 10101 Hillwood Pkwy, Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Martin R. Crane, Aviation Safety
Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101
Hillwood Pkwy, Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments prior to it becoming effective. However, we
invite you to participate in this rulemaking by submitting written
comments, data, or views. We also invite comments relating to the
economic, environmental, energy, or federalism impacts that resulted
from adopting this AD. The most helpful comments reference a specific
portion of the AD, explain the reason for any recommended change, and
include supporting data. To ensure the docket does not contain
duplicate comments, commenters should send only one copy of written
comments, or if comments are filed electronically, commenters should
submit them only one time. We will file in the docket all comments that
we receive, as well as a report summarizing each substantive public
contact with FAA personnel concerning this rulemaking during the
comment period. We will consider all the comments we receive and may
conduct additional rulemaking based on those comments.

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD No. 2015-0097, dated June 1, 2015,
to correct an unsafe condition for Agusta Model A109A and A109A II
helicopters. EASA advises that during a scheduled 100-flight-hour
inspection on a Model A109A II helicopter, unusual play was detected on
a part number (P/N) 109-0130-11-7 slider. Further investigation
revealed excessive wear of the slider broaching at the point of contact
with the tail rotor shaft. However, the cause of the excessive play and
wear has not been determined.
    This condition, if not detected and corrected, could lead to
reduced control of the helicopter, EASA advises. EASA consequently
requires repetitive inspections of slider P/N 109-0130-11-7 more
frequently than those performed at the 100-flight-hour inspection and
corrective actions depending on the findings. EASA advises that its AD
is an interim measure and further AD action may follow.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Italy and are approved for operation in the United States. Pursuant to
our bilateral agreement with Italy, EASA, its technical representative,
has notified us of the unsafe condition described in the EASA AD. We
are issuing this AD because we evaluated all information provided by
EASA and determined the unsafe condition exists and is likely to exist
or develop on other helicopters of these same type designs.

Related Service Information

    We reviewed AgustaWestland Bollettino Tecnico No. 109-149, dated
May 29, 2015, for Model A109A and A109A II helicopters. The bulletin
states that during a 100-flight-hour inspection of a Model A109A II
helicopter, ``anomalous'' play was found on a P/N 109-0130-11-7 slider.
After the slider was removed and inspected, extended, unusual wear of
the broaching in the point of contact with the tail rotor shaft was
found. Agusta states that the investigation is ongoing, but as a
precautionary measure it is reducing the slider inspection intervals
from 100 flight hours to 25 flight hours.

AD Requirements

    This AD requires, within 25 hours time-in-service (TIS) and
thereafter at intervals not to exceed 25 hours TIS, inspecting the
slider for play. If there is any play that exceeds 2.3 millimeters
(0.09 inch), this AD requires replacing the slider with an airworthy
slider before further flight.

Interim Action

    We consider this AD to be an interim action. The design approval
holder has not determined the cause of the unsafe condition identified
in this AD. If a cause is determined and actions developed to address
the cause, we might consider additional rulemaking.

Costs of Compliance

    We estimate that this AD will affect 36 helicopters of U.S.
Registry and that labor costs average $85 a work-hour. Based on these
estimates, we expect the following costs:
     Inspecting the slider for play requires 1 work-hour for a
labor cost of $85 per helicopter and $3060 for the U.S. fleet.
     Replacing the slider requires 10 work-hours and $4068 in
parts for a total cost of $4918 per helicopter.
    According to Agusta's service information, some of the costs of
this AD may be covered under warranty, thereby reducing the cost impact
on affected individuals. We do not control warranty coverage by Agusta.
Accordingly, we have included all costs in our cost estimate.

FAA's Justification and Determination of the Effective Date

    Providing an opportunity for public comments prior to adopting
these AD requirements would delay implementing the safety actions
needed to correct this known unsafe condition. Therefore, we find that
the risk to the flying public justifies waiving notice and comment
prior to the adoption of this rule because the unsafe condition can
adversely affect control of the helicopter and the required corrective
actions must be accomplished within 25 hours TIS. These helicopters
have a variety of uses, including search-and-rescue and medical
flights, and are expected to accumulate 25 hours TIS within a few
weeks.
    Since an unsafe condition exists that requires the immediate
adoption of this AD, we determined that notice and opportunity for
public comment before issuing this AD are impracticable and contrary to
the public interest and that good cause exists for making this
amendment effective in less than 30 days.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
Government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed, I certify that this AD:
    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);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, 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):

2015-25-04 Agusta S.p.A.: Amendment 39-18342; Docket No. FAA-2015-
3783; Directorate Identifier 2015-SW-027-AD.

(a) Applicability

    This AD applies to Agusta S.p.A. (Agusta) Model A109A and A109A
II helicopters with a slider assembly pitch control (slider) part
number 109-0130-11-7 installed, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as excessive wear and play
on a slider. This condition could result in loss of tail rotor pitch
control and consequently loss of helicopter control.

(c) Effective Date

    This AD becomes effective December 24, 2015.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 25 hours time-in-service (TIS) and thereafter at
intervals not to exceed 25 hours

TIS, inspect the slider for play. If there is play greater than 2.3
millimeters (0.09 inch), replace the slider with an airworthy slider
before further flight.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Martin R. Crane, Aviation Safety
Engineer, Safety Management Group, Rotorcraft Directorate, FAA,
10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    (1) AgustaWestland Bollettino Tecnico No. 109-149, dated May 29,
2015, which is not incorporated by reference, contains additional
information about the subject of this AD. For service information
identified in this AD, contact AgustaWestland, Product Support
Engineering, Via del Gregge, 100, 21015 Lonate Pozzolo (VA) Italy,
ATTN: Maurizio D'Angelo; telephone 39-0331-664757; fax 39-0331-
664680; or at http://www.agustawestland.com/technical-bulletins. You
may review a copy of the service information at the FAA, Office of
the Regional Counsel, Southwest Region, Room 6N-321, 10101 Hillwood
Pkwy, Fort Worth, TX 76177.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency (EASA) AD No. 2015-0097, dated June 1, 2015. You may
view the EASA AD on the Internet at http://www.regulations.gov by
searching for and locating it in Docket No. FAA-2015-3783.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6720, Tail Rotor
Control System.

    Issued in Fort Worth, Texas, on December 2, 2015.
James A. Grigg,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2015-30973 Filed 12-8-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 202 (Thursday, October 18, 2018)] [Notices] [Pages 52826-52827] [FR Doc No: 2018-22713]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric

corporate filings:

    Docket Numbers: EC19-9-000.

    Applicants: GE Capital Global Holdings, LLC, Arlington Valley Solar

Energy II, LLC, CPV Fairview, LLC, Russell City Energy Company, LLC,

Caledonia Generating, LLC, Apollo Global Management, LLC.

    Description: Joint Application for Authorization Under Section 203

of the Federal Power Act, et al. of Arlington Valley Solar Energy II,

LLC, et al.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5154.

    Comments Due: 5 p.m. ET 11/1/18.

    Docket Numbers: EC19-10-000.

    Applicants: Clean Energy Future--Lordstown, LLC, Perennial

Lordstown, LLC.

    Description: Joint Application for Authorization Under Section 203

of the Federal Power Act, et al. of Clean Energy Future--Lordstown,

LLC, et al.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5165.

    Comments Due: 5 p.m. ET 11/1/18.

    Take notice that the Commission received the following electric

rate filings:

    Docket Numbers: ER13-821-012: ER12-281-011; ER10-1529-005.

    Applicants: Scrubgrass Generating Company, L.P. Northampton

Generating Company, L.P., Northern Iowa Windpower, LLC.

    Description: Notice of Change in Status of Scrubgrass Generating

Company, L.P., et al.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5165.

    Comments Due: 5 p.m. ET 10/31/18.

    Docket Numbers: ER14-152-009; ER13-1143-006; ER13-1144-006; ER10-

2196-005; ER17-1849-002; ER10-2740-013; ER15-1657-007; ER10-2742-012.

    Applicants: Elgin Energy Center, LLC, Essential Power OPP, LLC,

Essential Power Rock Springs, LLC, Lakewood Cogeneration, L.P.,

Nautilus Power, LLC, Rocky Road Power, LLC, SEPG Energy Marketing

Services, LLC, Tilton Energy LLC.

    Description: Notice of Non-Material Change in Status of Elgin

Energy Center, LLC, et al.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5177.

    Comments Due: 5 p.m. ET 11/1/18.

    Docket Numbers: ER18-2272-001.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Tariff Amendment: 2018-10-12_SA 3144 ETI-Liberty

County-ETI MPFCA (J472 J483) Sub Original to be effective 8/7/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5022.

    Comments Due: 5 p.m. ET 11/2/18.

    Docket Numbers: ER18-2336-001.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Tariff Amendment: 2018-10-12_SA 3150 CMS Energy

Resource-METC GIA (J571) Substitute Original to be effective 8/15/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5026.

    Comments Due: 5 p.m. ET 11/2/18.

    Docket Numbers: ER19-89-000.

    Applicants: North Rosamond Solar, LLC.

    Description: Baseline eTariff Filing: Market-Based Rate

Authorization and Request for Waivers and Blanket Approvals to be

effective 10/12/2018.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5146.

    Comments Due: 5 p.m. ET 11/1/18.

    Docket Numbers: ER19-90-000.

    Applicants: Clean Energy Future--Lordstown, LLC.

    Description: Baseline eTariff Filing: Reactive Power Tariff

Application to be effective 12/1/2018.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5150.

    Comments Due: 5 p.m. ET 11/1/18.

    Docket Numbers: ER19-91-000.

    Applicants: GRP Franklin, LLC.

    Description: Baseline eTariff Filing: Application for Market Based

Rate to be effective 12/8/2018.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5163.

    Comments Due: 5 p.m. ET 10/31/18.

    Docket Numbers: ER19-92-000.

    Applicants: GRP Madison, LLC.

    Description: Baseline eTariff Filing: Market Based Rate Application

to be effective 12/8/2018.

    Filed Date: 10/10/18.

    Accession Number: 20181010-5164.

    Comments Due: 5 p.m. ET 10/31/18.

    Docket Numbers: ER19-93-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Sec.  205(d) Rate Filing: 2018-10-12_SA 3175 Deltas

Edge--EMI GIA (J679) to be effective 9/27/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5028.

    Comments Due: 5 p.m. ET 11/2/18.

    Docket Numbers: ER19-94-000.

    Applicants: Clear River Energy LLC, Invenergy Energy Management

LLC.

    Description: Request for Limited Waiver, et al. of Clear River

Energy LLC, et al.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5176.

    Comments Due: 5 p.m. ET 10/25/18.

    Docket Numbers: ER19-95-000.

    Applicants: North Rosamond Solar, LLC.

    Description: Sec.  205(d) Rate Filing: Filing of Shared Facilities

Common Ownership Agreement (Rattlesnake substation) to be effective 10/

14/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5053.

    Comments Due: 5 p.m. ET 11/2/18.

    Docket Numbers: ER19-96-000.

    Applicants: North Rosamond Solar, LLC.

    Description: Sec.  205(d) Rate Filing: Certificates of Concurrence

for Shared Facilities Agreements to be effective 10/14/2018.

    Filed Date: 10/12/18.

    Accession Number: 20181012-5054.

    Comments Due: 5 p.m. ET 11/2/18.

    Docket Numbers: ER19-97-000.

    Applicants: Southwest Power Pool, Inc.

    Description: Reliability Penalty Cost Recovery, et al. of Southwest

Power Pool, Inc.

    Filed Date: 10/11/18.

    Accession Number: 20181011-5178.

    Comments Due: 5 p.m. ET 11/1/18.

    The filings are accessible in the Commission's eLibrary system by

clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above

proceedings must file in accordance with Rules 211 and 214 of the

Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00

p.m. Eastern time on the specified comment date. Protests may be

considered, but intervention is necessary to become a party to the

proceeding.

    eFiling is encouraged. More detailed information relating to filing

requirements, interventions, protests, service, and qualifying

facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>

(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 12, 2018.

Nathaniel J. Davis, Sr.,

Deputy Secretary.

[FR Doc. 2018-22713 Filed 10-17-18; 8:45 am]

 BILLING CODE 6717-01-P