[Federal Register: July 11, 2008 (Volume 73, Number 134)]
[Notices]
[Page 40002-40005]
[DOCID:fr11jy08-87]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58101; File No. SR-NASDAQ-2008-033]

Self-Regulatory Organizations; The NASDAQ Stock Market, LLC;
Notice of Filing of Proposed Rule Change as Modified by Amendment No. 1
Thereto Related to Submission of Non-Tape Reports

July 3, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 18, 2008, The NASDAQ Stock Market, LLC (``Nasdaq'' or the
``Exchange'') 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 substantially prepared by the
Exchange. On July 3, 2008, Nasdaq filed Amendment No. 1 to the proposed
rule change. The Commission is publishing this notice to solicit
comments on the proposed rule change, as amended, from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq is proposing a rule change to: (1) Offer functionality
allowing the submission of non-tape riskless principal reports using
Nasdaq's Automated Confirmation Transaction Service (``ACT''); (2)
allow the collection and transfer of fees among Nasdaq members using
such submissions, as well as for step-outs; and (3) expand the use of
step-outs to include journal entry position movement.
    The text of the proposed rule change is below. Proposed new
language is in italics; proposed deletions are in brackets.\3\
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    \3\ Changes are marked to the rule text that appears in the
electronic manual of Nasdaq found at http://nasdaq.complinet.com.
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7038. Step-Outs and Sales Fee Transfers

    (a) A Nasdaq member may enter a non-tape, non-clearing submission
into the Automated Confirmation Transaction Service (``ACT'') for the
purpose of transferring all or a portion of the obligation to pay a
Rule 7002 Sales Fee or similar fee of another self-regulatory
organization that is associated with a previously executed trade to one
or more other Nasdaq members.
    (b) A Nasdaq member may enter a non-tape, clearing-only submission
into ACT for the purpose of [:
    (i) Transferring all or a portion of the member's position in a
previously executed trade to one or more other Nasdaq members on whose
behalf the trade was executed;
    (ii) Transferring all or a portion of the member's position in an
account of the member at one clearing broker to an account of the
member at another clearing broker] transferring securities from one
member to another, provided that the transfer does not constitute a
transaction in securities that is otherwise subject to reporting that
has not, in fact, been previously and separately reported as a
transaction. When submitting a non-tape, clearing-only submission that
is used to transfer a position from one member to another member, the
submitting member may also indicate that the obligation to pay a Sales
Fee or similar fee associated with the position should be transferred.
    (c) When ACT is used to transfer a position along with a Sales Fee
or similar fee, all parties to the transfer must be Nasdaq members and
[must] may be party to an agreement authorizing the transferring party
to enter into locked-in trades on its behalf. When ACT is used to
transfer Sales Fees or similar fees [without the transfer of the
underlying shares] without an accompanying transfer of a securities
position, the clearing firms for the trades in question must be
part[y]ies to an agreement authorizing such transfers between
themselves and/or the firms on whose behalf they clear trades.
    (d) A Nasdaq member is prohibited from using a non-tape, clearing-
only ACT submission [entered into ACT] for the purpose of [reporting a
trade execution] effecting a transaction required to be trade reported
or reporting a trade for regulatory purposes. Submission of non-tape,
clearing, or non-tape, non-clearing records into ACT by Nasdaq members
does not satisfy any obligation such members may have to report
transactions as required by the applicable rules of other self-
regulatory organizations.
    (e)-(f) No Change.
* * * * *

7042. Non-Tape Riskless Submissions

    Nasdaq members may make non-tape submissions into the Automated
Confirmation Transaction Service (``ACT'') to facilitate riskless
transactions taking place on national securities exchanges, or over-
the-counter, as follows:
    (a) For riskless transactions in which a member, after having
received an order to buy a security, purchases the security at the same
price to satisfy the order to buy or, after having received an order to
sell, sells the security at the same price to satisfy the order to
sell, the member may submit, for the offsetting ``riskless'' portion of
the transaction either:
    i. A clearing-only report with a capacity indicator of ``riskless
principal,'' ``agency,'' or ``intra-broker'' if a clearing report is
necessary to clear the transaction; or
    ii. A non-tape, non-clearing report with a capacity indicator of
``riskless principal,'' ``agency'' or ``intra-broker'' if a clearing
report is not necessary to clear the transaction.
    (b) Nothing in this Rule shall relieve any member or other party
from its obligation to fully and properly report transactions as
required by the applicable rules of other self-regulatory
organizations.
* * * * *

7043. Inclusion of Transaction Fees in Clearing Reports Submitted to
ACT

    (a) Nasdaq members may agree in advance to transfer a transaction
fee charged by one member to another member on a transaction effected
on an exchange or otherwise through the submission of a clearing report
to the Automated Confirmation Transaction Service (``ACT''). Such
report, inclusive of the transaction fee, will be submitted to the
National Securities Clearing Corporation for processing. To facilitate
the transfer of the transaction fee, the report submitted to ACT shall
provide, in addition to all other information required to be submitted,
a total per share or contract price amount, inclusive of the
transaction fee. Such reports shall only submitted where there exists a
written agreement between the members permitting the submission of fee-
inclusive clearing reports between them. Nothing in this paragraph
shall relieve a member from its obligations under Nasdaq rules and the
federal securities laws. The ability to transfer transaction fees as
described above shall be limited to transactions and/or submissions
made pursuant to Rule 7038 or 7042.
    (b) The fee for submission of the above shall be $0.03 per side.
* * * * *
    (b) Not applicable.
    (c) Not applicable.
* * * * *
    The text of the proposed rule change is also available on the
Exchange's Web site (http://www.nasdaqtrader.com), at

Nasdaq's Office of the Secretary, 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 aspects of such
statements.

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

1. Purpose
    Nasdaq is proposing a rule change to: (1) Allow Nasdaq members to
submit non-tape, riskless reports using Nasdaq's Automated Confirmation
Transaction Service (``ACT''); (2) allow Nasdaq members to use ACT to
collect and transfer fees in connection with non-tape, riskless
principal submissions and step-outs; and (3) broaden the scope of
permitted step-outs.
Non-Tape Riskless Submission
    Nasdaq proposes to establish a functionality that will allow Nasdaq
exchange member submission of non-tape, riskless reports (including the
non-tape portion of a riskless transaction taking place on other
national securities exchanges or over-the-counter) to ACT.\4\ These
reports are intended to facilitate the transfer of information between
parties to the transactions; make electronically available trade record
information in the system to parties; and, if requested, the ultimate
transmission of the transfer records to an appropriate clearing agency.
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    \4\ ACT is a technology asset of Nasdaq. Prior to the
commencement of operation of the Trade Reporting Facility (now the
FINRA/Nasdaq TRF) and the start of Nasdaq's operation as a national
securities exchange in August 2006, it was common for industry
participants to refer to 'reporting trades to ACT.' Now, ACT
technology serves multiple SROs/markets and provides an electronic
system through which certain trades, transfers, and instructions can
be reported or communicated. Among other functions, ACT connects to
DTCC's continuous net settlement and trade comparison systems for
equities, with all clearing submissions being marked to accurately
reflect the executing market. ACT responds to all entries with
rejects or acknowledgements, stores all records submitted to it, and
provides both step-out and sales fee transfer capabilities to users.
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    In defining what constitutes a riskless transfer, Nasdaq has
determined to follow the general standard for riskless principal
transactions articulated in Financial Industry Regulatory Authority
(``FINRA'') Rule 4632(d)(3)(B) and require that the Nasdaq member have
had an order in hand, and have given the party providing the order the
same price as the Nasdaq member obtained in the public marketplace,
prior to the submission of post-trade riskless transfer entry, either
as principal or agent, into ACT. These riskless submissions into ACT
are voluntary and do not replace any separate reporting obligation that
may also be applicable. Under the proposal, Nasdaq members will be
allowed to submit records for riskless transfers using the following
capacities: ``Riskless Principal'' where the member acted as principal
on the open market trade or trades related to the riskless submission;
``Agent'' where the member acted as agent on the open market trade or
trades related to the riskless submission; and ``Intra-Broker'' where
the transfer is occurring strictly within a member Firm.
    In FINRA Notice to Members 2007-38, that SRO allowed, among other
things, the submission of certain non-tape reports to represent the
offsetting riskless portion of a previously executed public market
trade while restricting its members' ability to submit such non-tape
reports to a FINRA facility if the public trade report was not also
reported to a FINRA facility. The only exception to this prohibition
was if the non-tape report was submitted to reflect the offsetting
portion of a riskless principal transaction or an agency transaction
where a firm acts as agent on behalf of another member firm. As such,
FINRA's rule prevents firms from using a market's (FINRA's)
functionality to facilitate riskless securities transfers between two
broker units of a single member.\5\ Nasdaq, however, believes that
using non-tape reports in such a manner is desirable and proposes
offering an ``Intra-Broker'' non-tape reporting capacity submission for
use in these circumstances. For example, Firm ABCD and ABCQ are
entities of ABC Brokerage, but two completely different business units.
ABCD uses ABCQ's systems to access liquidity in the marketplace. In the
market, ABCQ is the broker against which clearing of the public market
trade is submitted. ABCD and ABCQ clear separately. ABCQ needs to get
the shares to ABCD. It's not a trade, and because they're the same
broker from a member perspective, they can't move the shares as a
riskless transfer under FINRA's rules. In this situation, use of the
``Intra-Broker'' capacity through Nasdaq's ACT system would be
available.
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    \5\ In effect, FINRA's position prohibits a firm from moving
riskless share potions to itself. Consolidation through merger and
acquisition is common in the securities industry, and there are
environments where, due to lack of integration, it would be
preferable for firms to move shares between elements of the same
broker by submitting appropriate non-tape share transfer reports to
and through a third-party system (like ACT) rather than in-house
systems--if they exist.
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    The riskless reports may be used for clearing, non-clearing, QSR,
and Give-Ups. Nasdaq will continue to honor Attachment 2's and Uniform
Trade Reporting Agreements on file with it or the FINRA/Nasdaq TRF.
When used with clearing, or otherwise specifically requested, the
reports shall also be included in Nasdaq Risk Management calculations.
Submission of non-tape, clearing, or non-tape, non-clearing records
into ACT by Nasdaq members will not satisfy any obligation the member
may otherwise have to report or represent the same transactions under
the rules of any other self-regulatory organization.
Transaction Fees
    Current trade-reporting rules of other SROs allow transaction fees
to be included in clearing reports. Nasdaq proposes to establish
similar rules for transaction fees to be included in clearing reports
that are submitted in connection with non-tape, riskless principal
submissions and step-outs. Under the proposal, Nasdaq members may also
seek to impose or transfer to another Nasdaq member such transaction
fees in the clearing reports that Nasdaq forwards to the National
Securities Clearing Corporation (``NSCC'') for trade clearance. Nasdaq
will impose a $0.03 per-side fee for each such clearing report. Nasdaq
notes that under NASD Rule 7002B, FINRA/Nasdaq TRF participants are
charged a fee of $0.03 per side for submission of a clearing report to
transfer a transaction fee charged by one FINRA member to another.
Step-Outs
    Although not defined by rule, a step-out is transfer of all or a
portion of a broker-dealer's securities position to another broker-
dealer that does not constitute a trade.\6\
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    \6\ For example, one broker might buy a block of securities on
behalf of several other broker-dealer customers. That broker
``steps-out'' of the initial trade to transfer all or a portion of
its position to its broker-dealer customers. In this situation, the
block transaction effected in a securities market will contain
instructions for NSCC to allocate certain positions to the stepped-
out broker's customers. In another form of a step-out that occurs
outside a securities exchange, a broker uses a clearing-only report
through ACT to transfer some or all of its securities position from
an account at one clearing broker to an account at another clearing
broker, for its own internal accounting purposes.

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    This filing builds upon Nasdaq's previous attempts to provide
useful step-out parameters for its members. Nasdaq initially offered
step-out capability in 2007 in light of FINRA rules that restricted
step-outs to those portions of trades that were originally executed by
and reported to FINRA facilities.\7\ Nasdaq viewed this requirement as
overly restrictive because certain broker-dealers wished to engage in
step-outs but either did not have systems in place to capture the venue
of the original trade execution and/or may have executed various
portions of the underlying trade in non-FINRA facilities, thereby
preventing them from being able to comply with the FINRA requirements.
Accordingly, Nasdaq allowed step-out capability with respect to any
trade that a Nasdaq member was a party to regardless of the market on
which the trade was executed.\8\
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    \7\ See Securities Exchange Act Release No. 56345 (Aug. 31,
2007), 72 FR 51880 (Sep. 11, 2007).
    \8\ The step-out report submitted to ACT under this rule change
was marked as a Nasdaq Exchange entry so as to clearly distinguish
it from an NASD/Nasdaq TRF entry, which also is reported through
ACT. Also under this rule change, the parties to a step-out under
Nasdaq rules must all be Nasdaq members and must be parties to an
agreement such as the NASD's new Uniform Trade Reporting Facility
Service Bureau/Executing Broker Agreement under which the broker
transferring the position has received authorization from the
transferee broker to act on its behalf.
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    Nasdaq amended its step-out rules again in 2007 to specify that an
authorizing agreement is required between clearing firm members when
they seek to transfer certain sales fees but not the underlying shares;
no authorizing agreement is required when Nasdaq members conduct step-
outs when such transfers are accompanied by a transfer of the
underlying shares only.\9\
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    \9\ See Securities Exchange Act Release No. 56929 (Dec. 7,
2007), 72 FR 71176 (Dec. 14, 2007).
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    In this filing, Nasdaq proposes to further broaden its step-out
parameters. First, Nasdaq would expand the scope of step outs to
include all securities transfers from one Nasdaq member to another
provided that the transfer does not constitute a reportable trade.
Thus, under the proposed rule, the step-out could not only be used to
allocate securities positions originating from a previously executed
trade \10\ or to transfer securities from one clearing member to
another clearing member for accounting purposes \11\ but also, for
example, for stock loan purposes to service a short position.\12\
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    \10\ See Nasdaq Rule 7038(b)(i).
    \11\ See Nasdaq Rule 7038(b)(ii).
    \12\ See Proposed Rule 7038(b).
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    Second, Nasdaq proposes to eliminate the authorizing agreement
requirement when Nasdaq members use ACT to effect a step-out along with
a sales or similar fee. Nasdaq states that step-outs are already
completed pursuant to formal agreements among Nasdaq members or through
ACT's comparison processes, which renders the current Nasdaq
requirement unnecessarily duplicative. Nasdaq points out that the
transaction comparison process requires the implicit acquiescence of
both parties for the ACT system to complete the step-out transaction.
In other words, a member will retain an opportunity to manually reject
or reverse the step-out and fee transfer arrangement if it disagrees
with their terms when presented to it even after it is initially
affirmed. As support for this proposed rule change, Nasdaq states that
it determined through discussions with its member firms that many firms
preferred to handle step-outs on a match/compare basis, i.e. manually,
even when they had a fee agreement between them and that it was an
unnecessary burden for firms to sign separate agreements to move
Section 31 fees associated with step-out submissions to ACT since this
functionality already was in place on ACT.
    This proposed rule change would not change the requirement of a
formal sales fee transfer agreement between firms that wish to use ACT
to move sales fees without an accompanying transfer of securities.
Nasdaq believes that it is important to retain the requirement that the
parties to a fee transfer have a written agreement specifically
permitting such fee transfers because a sales fee transfer that moves
no shares is not a step-out and therefore there are no specific share
movements for firms to readily identify as being associated with the
fee transfer.
    Finally, Nasdaq proposes to clarify Nasdaq members' reporting
requirements associated with step-out submissions to ACT. Nasdaq
proposes to amend Rule 7038(d) by adding language that would state that
(1) members may not submit step-outs into ACT for the purpose of
``effecting'' (instead of ``reporting a trade execution'') a
transaction required to be trade reported; and (2) submitting step-outs
into ACT does not satisfy any other SRO's requirements that members
might have to report transactions.
    Nasdaq believes that the above proposals enhance the ability of
Nasdaq members to transfer securities positions and their associated
fees in an efficient and transparent manner.
2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\13\ in general, and with
Sections 6(b)(4) and (5) of the Act,\14\ in particular, in that the
proposal provides for the equitable allocation of reasonable dues, fees
and other charges among members and issuers and other persons using any
facility or system which Nasdaq operates or controls, and is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. Nasdaq believes that
enhancing its step-out and fee transfer functionality benefits its
members by enhancing the efficiency and transparency of their post-
trade operations. Nasdaq's proposed fees are reasonable and comparable
to other fees for reporting submissions.
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    \13\ 15 U.S.C. 78f.
    \14\ 15 U.S.C. 78f(b)(4) and (5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    Written comments were neither solicited nor received.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding, or (ii) as to
which Nasdaq consents, the Commission will:

    (A) By order approve such proposed rule change; or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2008-033 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-NASDAQ-2008-033. This
file number should be included on the subject line if e-mail 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 inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal offices 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-NASDAQ-2008-033 and should
be submitted on or before August 1, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
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    \15\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-15759 Filed 7-10-08; 8:45 am]

BILLING CODE 8010-01-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Shaja Joyner,<PHONE_NUMBER>

TEMPLATE:

BASF Corporation

PP#1F8974

	EPA has received a pesticide petition (#1F8974) from BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, North Carolina 27709-3528 requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of Fluxapyroxad, (BAS 700 F); 1H-Pyrazole-4-carboxamide,3-(difluoromethyl)-1-methyl-N-(3',4',5'-trifluoro[1,1'-biphenyl]-2-yl)-, its metabolites, and degradates in or on the raw agricultural commodity Avocado at 0.6 parts per million (ppm).  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. Nature of the residue studies were conducted in wheat, soybean and tomato as representative crops in order to characterize the fate of fluxapyroxad (BAS 700 F) in all crop matrices. Two radiocarbon labels were studied in each crop, with 14-C labels positioned in aniline and pyrazole ring structures. Fluxapyroxad was the predominant residue in most crops.  In all crops the fluxapyroxad Residues of Concern (ROC) were characterized as parent fluxapyroxad plus metabolites M700F048 and M700F002. A confined rotational crop study added metabolite M700F008 and confirmed that parent fluxapyroxad plus metabolites M700F008, M700F048 and M700F002 were the residues of concern in the representative rotational crops of wheat, radish, and spinach.

	2. Analytical method. Independently validated analytical methods have been submitted for analyzing residues of parent fluxapyroxad (BAS 700 F) plus metabolites M700F008, M700F048 and M700F002 with appropriate sensitivity in/on avocado.

	3. Magnitude of residues. Field trials using foliar treatment with a fluxapyroxad end-use product on avocado were performed to determine the magnitude of the residue in/on the representative raw agricultural commodities and processed fractions. The data are being submitted to propose tolerances for the avocado group 24B. The petition proposes a use rate with a 0-day preharvest interval for group 24B commodities. The number and locations of field trials are in accordance with OPPTS Guideline 860.1500. Field trials were carried out using the maximum label rates, the maximum number of applications and the minimum pre-harvest interval (PHI). Residues of M700F002 were generally less than the limit of quantitation and often less than the limit of detection. Detected residues of fluxapyroxad (BAS 700 F) in the commodities support the proposed tolerances based on parent BAS 700 F.

B. Toxicological Profile

	1. Acute toxicity.  Fluxapyroxad (BAS 700 F) displayed low acute toxicity via the oral, dermal and inhalation routes of exposure.  It was not irritating to the eyes, only slightly irritating to the skin, and not a dermal sensitizer. The acute toxicity studies place technical fluxapyroxad in toxicity category III for acute oral and dermal and category IV for acute inhalation, eye and skin irritation. Fluxapyroxad is not a dermal sensitizer.

	2. Genotoxicty. Fluxapyroxad (BAS 700 F) was not genotoxic in a battery of assays. Fluxapyroxad was negative for inducing mutations in bacterial and mammalian cell assays. No evidence of a clastogenic effect was observed in vitro or in vivo, and fluxapyroxad did not cause unscheduled DNA synthesis in hepatocytes of treated rats.

	3. Reproductive and developmental toxicity. The reproductive and developmental toxicity of fluxapyroxad (BAS 700 F) was investigated in a 2-generation rat reproduction study as well as in rat and rabbit developmental toxicity studies. In the reproduction study, there were no effects on fertility, up to the highest dose tested of 300 mg/kg bw/d. At the high- and mid- (50 mg/kg bw/d) doses tested, fluxapyroxad administration resulted in decreased food consumption, impaired body weight development, clinical chemistry and select organ weight changes and histopathology. Impairment of pup body weight development was also seen at these doses. The NOAEL for systemic and developmental toxicity was 10 mg/kg bw/day.

In the rat developmental toxicity study, slight maternal toxicity was observed at the high dose level of 1000 mg/kg bw/d, in the form of limited clinical chemistry, liver and thyroid weight effects, and thyroid histopathology. No evidence of developmental toxicity was observed in the rat up to the highest dose tested of 1000 mg/kg bw/d.

At the highest dose tested in the rabbit teratology study (60 mg/kg bw/d), maternal toxicity consisted of clinical signs, abortion, reduced food consumption, and impaired body weight development. The only developmental effect at the high dose, which caused substantial maternal toxicity, consisted of a commonly observed, reversible external variation, paw hyperflexion. Based on the effects described, the maternal and developmental NOAEL in rabbits was 25 mg/kg bw/d.

	4. Subchronic toxicity. The principal target organ in all studies in rats, mice and dogs was the liver, as indicated by organ weight changes and altered clinical chemistry parameters, which were consistent with liver enzyme induction. Histopathological changes in the liver were only evident in rats. The thyroid was also identified as a target organ in rats, as indicated by organ weight changes, histopathology and thyroid hormone changes. The lowest NOAEL in subchronic oral toxicity studies was approximately 7.3 mg/kg bw/day in the rat 90-day study.

No systemic toxicity was observed in a 28-day repeat dose dermal toxicity study at doses as high as 1000 mg/kg bw/day.

The neurotoxic potential of fluxapyroxad (BAS 700 F) was studied following both acute and subchronic oral administration in the rat. In the acute study, treatment-related neurobehavioral effects were noted in mid and high dose animals on the day of treatment. These consisted of slight increases of the landing foot-splay in high dose males, reduction in the number of rearings in males, and impaired motor activity in high and mid dose males and females. No effects on these parameters were observed on study days 7 and 14. Additionally, no treatment-related neuropathological findings (brain weight changes, neurohistopathological findings) were observed. Therefore, the affected parameters indicated a neuropharmacological effect rather than neuronal damage. Based on the results of this study the NOAEL for acute neurotoxicity was 125 mg/kg bw/d in male and female rats.

There was no indication of clinical (general clinical observation, FOB and motor activity) or neurohistopathological neurotoxicity in a subchronic neurotoxicity study. Systemic signs of toxicity were consistent with those seen in repeated dose studies with fluxapyroxad. Under the conditions of the present study the no observed adverse effect level (NOAEL) for neurotoxicity was 5000 ppm (approximately 320 mg/kg bw/d), the highest dose tested.

	5. Chronic toxicity. Systemic toxicity in long term oral exposure studies in dogs, mice and rats included effects on food consumption, body weight development and clinical chemistry changes. The liver was identified as the main target organ in all species tested, as indicated by liver weight changes and non-neoplastic lesions. Additional target organs in the rat included the thyroid and bones. The spleen, gall bladder and prostate were affected in dogs.

Fluxapyroxad (BAS 700 F) was not carcinogenic in C57BL mice following continuous dietary administration for 18 months at dietary concentrations up to 6000 ppm (approximately 1000 mg/kg bw/d). Treatment of fluxapyroxad for 2 years in rats resulted in the induction of hepatocellular tumors in males at dose levels >= 250 ppm and in females at >= 1500 ppm. A mitogenic, Phenobarbital-like mechanism is proposed as the probable mode of action for liver tumor development in rats. This was supported by mechanistic studies on enzyme induction and S-Phase response in the liver, and indicates there is a threshold for tumor development and a margin of exposure cancer risk assessment is appropriate.

In the rat chronic/oncogenicity study, the NOAEL in males and females was 50 ppm (2.1 and 2.7 mg/kg bw/day, respectively). NOAEL's in the mouse oncogenicity study were 150 ppm in males (21 mg/kg bw/day) and in females (33 mg/kg bw/day).  In a chronic dog study, the NOAEL was 300 ppm (approximately 8 mg/kg bw/day).

	6. Animal metabolism. The rat, goat and hen metabolism studies were conducted to determine the nature of the fluxapyroxad (BAS 700 F) residues in animals. Studies were conducted with radiolabeled fluxapyroxad with 14-C labels positioned in aniline and pyrazole ring structures (hen metabolism, aniline ring label only). BAS 700 F was either excreted rapidly in urine and feces or transformed to a number of metabolites after administration to animals. All relevant metabolites were identified. Unchanged parent compound was found as the predominant component in most animal matrices. The metabolism of fluxapyroxad in the animals is well understood. Degradation proceeds via N-demethylation of the pyrazole ring and/or hyroxylation of the biphenyl ring followed by subsequent O- and N-conjugation reactions to produce metabolites that are rapidly excreted, along with parent, and do not readily accumulate in tissues or milk. Residues in milk and most edible tissues are low. The same metabolic reactions were observed in each of the animals studied, so there is a consistent metabolic pathway for fluxapyroxad in animals.  Rat, goat and hen metabolism studies were also conducted with radiolabeled M700F048, a N-glucoside of N-desmethyl BAS 700F, a plant metabolite, seen at levels >10 TRR in soybean seed in the plant metabolism study.  In all animals, the glucoside was readily hydrolyzed to generate M700F008, a key intermediate in the metabolism of fluxapyroxad in animals. The radiolabeled residue was rapidly excreted with little uptake in tissue, following a metabolic pathway in all animals like that for fluxapyroxad.  Rat, goat and hen metabolism studies were also conducted with radiolabeled M700F002, a carboxylic acid attached to the pyrazole-ring formed by cleavage of the fluxapyroxad carboxamide bond.  M700F002 was seen at levels >10 TRR in soybean seed in the plant metabolism and was present only at low levels in the rat urine. In lieu of a fish metabolism study, a justification was submitted to waive the data requirement for a metabolism study in fish. The justification was based on the relatively low BCF of 25 in edible tissues of bluegill sunfish and the negligible BCF of <1 in the crayfish field accumulation study. This was sufficient information to fulfill the requirements for the use in rice, including in paddy rice, an aquatic system. BASF does not believe that an additional metabolism study in a bottom feeder (catfish) or predator (bass) fish will provide any new information that would add value to the existing Fluxapyroxad data package.  In all animal studies, M700F002 was not metabolized and was almost completely and rapidly excreted unchanged, with no uptake in tissue.

	7. Metabolite toxicology. The metabolism of fluxapyroxad (BAS 700 F) is similar in plants and mammals.  The metabolism of fluxapyroxad, both in plants and animals, is largely based on two key transformation reactions, N-demethylation of the pyrazole moiety and hydroxylation of the biphenyl moiety.  Both reactions, combinations thereof, and subsequent conjugation reactions (e.g. glucose, glucuronic acid, cysteine) result in a range of common and structurally related compounds.  Due to the similar structural nature of most metabolites, the toxicity of most plant metabolites is adequately estimated from the results of studies performed with fluxapyroxad in animals. In addition, the metabolism of metabolites M700F002, and M700F048 were each investigated in rat, goat and hen. Animal metabolism studies were performed with M700F002 since the plant metabolite was seen in the rat metabolism only at low levels in urine. In rat, goat and hen, M700F002 is rapidly and almost completely excreted unchanged with almost no uptake in tissue, milk or eggs.  M700F002 is not metabolized in animal to any significant extent.

Animal metabolism studies were performed with M700F048, a glucoside conjugate since the plant metabolite would not be formed in animal metabolism. In animal metabolism studies, M700F048 was rapidly hydrolyzed to metabolite M700F008, a key metabolite in the metabolic pathway of fluxapyroxad. Unchanged M700F048 was not detected in edible animal commodities.

Toxicology studies (Acute oral toxicity, Ames test, in vitro mutagenicity test in mammalian cells, in vitro chromosome aberration test, in vivo mouse micronucleus, 28/90-day rat feeding and developmental toxicity in rabbits) were conducted on three metabolites. Overall, M700F001, M700F002 and M700F048 are of low acute and subchronic toxicity in rats. The metabolites showed no genotoxic potential in a battery of genotoxicity studies. In addition, no adverse effects were observed up to the highest doses tested in developmental toxicity study with rabbits.

	8. Endocrine disruption. No specific tests have been conducted with fluxapyroxad (BAS 700 F) to determine whether the chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects.  However, there were no significant findings in other relevant toxicity studies (e.g., sub-chronic and chronic toxicity, developmental toxicity and multi-generation reproductive studies) which would suggest that fluxapyroxad produces any endocrine disruption.

C. Aggregate Exposure

	1. Dietary exposure. The tolerance expression for dietary risk assessment is fluxapyroxad (BAS 700 F) and M700F008 in plant and animal commodities except milk, for which M700F010 is also included.  Exposure assessments were conducted to evaluate the potential risk due to acute and chronic dietary exposure of the U.S. population and all sub-populations. The assessments included all current established tolerances (40 CFR 180.666) and the use in avocado, proposed in this petition. The acute and chronic dietary exposure estimates were conducted using DEEM, version 4.02 which includes the consumption data from the NHANES 2-day food consumption data for 2005 to 2010.

 Food.
      Acute Dietary Exposure Assessment

The acute dietary exposure values are shown in Table 1. A conservative acute dietary analysis was performed utilizing DEEM input values from the US EPA's 2016 dietary and risk assessment evaluation, in addition to the newly proposed tolerances for avocado. Tolerance level residues were adjusted to account for the metabolites of concern (M700F008). Established and newly proposed tolerances (avocado) were multiplied by a factor or 1.5x to account for the M700F008 metabolite for plant commodities. This factor was inserted into Adjustment Factor 2 for the acute analysis. Processing factors including DEEM default and empirical processing factors used in the dietary assessment conducted as part of the evaluation by EPA in March of 2021. Study derived processing factors were used for citrus, grape, cottonseed, rice and sugarcane process commodities. The analysis assumed 100% of all crops were treated.  The residue levels used for ruminant and poultry commodities were derived from the EPA tolerances approved in 2016. Anticipated residues accounting for parent and the metabolites of concern (M700F008 and/or M700F010) were used.

For drinking water all fluxapyroxad (BAS 700 F) uses were examined at maximum use rates, maximum number of applications, and all proposed application methods to determine which use would result in the highest water concentrations.  The highest acute Estimated Drinking Water Concentrations (EDWC) was estimated to be 203 ug/L (ppb). The drinking water exposure was included in the dietary analysis in Table 1.

The resulting exposure estimates were compared against the fluxapyroxad (BAS 700 F) acute Population Adjusted Dose (aPAD) of 1.25 mg/kg b.w./day for all populations. The endpoint is based on the NOAEL of 1.25 mg/kg/day with an FQPA safety factor of 1.  The most highly exposed sub-population was children 1-2 years old with 14.1 % utilization of the aPAD (Table 1; DEEM, version 4.02) (Table 2; CARES NG[(R)], version 1.2.1).

Table 1. Results for fluxapyroxad (BAS 700 F) Acute Dietary Exposure (Food and Water) Considering all Current and Proposed Tolerances using DEEM-FCID at the 95th Percentile

                                  Population
                               Exposure Estimate
                                    % aPAD
                                   Subgroups
                               (mg/kg b.w./day)

                                U.S. Population
                                   0.103199
                                      8.3
                         All Infants (< 1 year old)
                                   0.148390
                                     11.9
                           Children (1-2 years old)
                                   0.176300
                                     14.1
                           Children (3-5 years old)
                                   0.154535
                                     12.4
                           Children (6-12 years old)
                                   0.099210
                                      7.9
                            Youth (13-19 years old)
                                   0.080612
                                      6.4
                           Adults (20-49 years old)
                                   0.096840
                                      7.7
                            Adults (50+ years old)
                                   0.098169
                                      7.9
                           Females (13-49 years old)
                                   0.101148
                                      8.1

Table 2. Results for fluxapyroxad (BAS 700 F) Acute Dietary Exposure (Food and Water) Considering all Current and Proposed Tolerances using CARES NG(R) at the 95th Percentile

                                  Population
                               Exposure Estimate
                                    % aPAD
                                   Subgroups
                               (mg/kg b.w./day)

                                U.S. Population
                                   0.103236
                                      8.3
                         All Infants (< 1 year old)
                                   0.148651
                                     11.9
                           Children (1-2 years old)
                                   0.176407
                                     14.1
                           Children (3-5 years old)
                                   0.154658
                                     12.4
                           Children (6-12 years old)
                                   0.098765
                                      7.9
                            Youth (13-19 years old)
                                   0.080505
                                      6.4
                           Adults (20-49 years old)
                                   0.096870
                                      7.7
                            Adults (50+ years old)
                                   0.098410
                                      7.9
                           Females (13-49 years old)
                                   0.101001
                                      8.1

The results of the analysis show that for all populations, the estimated exposures are well below the Agency's level of concern (< 100% aPAD). Additional refinements in the dietary risk assessment (i.e. utilizing anticipated residue values, percent crop treated values) would further reduce the estimated exposure values.

Chronic Dietary Exposure Assessment
For plant commodities, the residue levels were done according to the 2021 US EPA acute and chronic risk assessment evaluation. This petition includes the newly proposed avocado tolerance. The combined average field trial residues for parent plus the maximum M700F008 metabolite residue was used; this first-tier analysis was conducted by the US EPA to save resources instead of adding individual residues of parent and M700F008 from individual trials and then calculating the average. Processing factors including DEEM default and empirical processing factors used in the dietary assessment conducted as part of the evaluation by EPA in March 2021 were included. Study derived processing factors were used for citrus, grape, cottonseed, rice and sugarcane process commodities. The analysis assumed 100% of all crops were treated.  The residue levels used for ruminant and poultry commodities were derived by extrapolation from residue levels of parent and M700F008 measured in the feeding studies based on the newly calculated feed burdens. The metabolite M700F010 was considered to be equal to fluxapyroxad levels in milk. The tolerances of 0.01 mg/kg were used for freshwater finfish, shellfish, crustacean and hog, meat, byproducts.

For drinking water all fluxapyroxad (BAS 700 F) uses were examined at maximum use rates, maximum number of applications, and all proposed application methods to determine which use would result in the highest water concentrations.  The highest chronic Estimated Drinking Water Concentration (EDWC) was estimated to be 188 ug/L (ppb). The drinking water exposure was included in the dietary analysis in Table 3.

The consumption data was from the NHANES 2-day food consumption data for 2005 to 2010 and the assessment was performed using the Dietary Exposure Evaluation Module (DEEM-FCID) software, version 4.02. A side-by-side comparison using Cumulative and Aggregate Risk Evaluation System-New Generation (CARES NG[(R)]), version 1.2.1 was also provided.

The chronic Population Adjusted Dose (cPAD) used for U.S. population and all sub-populations is 0.021 mg/kg bw/day. This endpoint is based on the NOAEL value of 2.1 mg/kg bw/day using a FQPA safety factor of 1.  The most highly exposed population sub-group was all infants (< 1 year old) which utilized 91.4% cPAD using DEEM and 92.9% using CARES NG[(R)].  The results of the chronic dietary assessment are presented in Table 3 and Table 4.

Table 3.  Results for fluxapyroxad (BAS 700 F) Chronic Dietary Exposure (Food and Water) Considering All Current and Proposed Tolerances using DEEM-FCID
                                  Population
                               Exposure Estimate
                                    % cPAD
                                   Subgroups
                               (mg/kg b.w./day)

                                U.S. Population
                                   0.006956
                                     33.1
                         All Infants (< 1 year old)
                                   0.019197
                                     91.4
                           Children (1-2 years old)
                                   0.014496
                                     69.0
                           Children (3-5 years old)
                                   0.010981
                                     52.3
                           Children (6-12 years old)
                                   0.006919
                                     32.9
                            Youth (13-19 years old)
                                   0.004814
                                     22.9
                           Adults (20-49 years old)
                                   0.006449
                                     30.7
                            Adults (50+ years old)
                                   0.006503
                                     31.0
                           Females (13-49 years old)
                                   0.006365
                                     30.3

Table 4.  Results for fluxapyroxad (BAS 700 F) Chronic Dietary Exposure (Food and Water) Considering All Current and Proposed Tolerances using CARES NG[(R)]

                                  Population
                               Exposure Estimate
                                    % cPAD
                                   Subgroups
                               (mg/kg b.w./day)

                                U.S. Population
                                   0.007081
                                     33.7
                         All Infants (< 1 year old)
                                   0.019512
                                     92.9
                           Children (1-2 years old)
                                   0.014795
                                     70.5
                           Children (3-5 years old)
                                   0.011308
                                     53.8
                           Children (6-12 years old)
                                   0.007159
                                     34.1
                            Youth (13-19 years old)
                                   0.004939
                                     23.5
                           Adults (20-49 years old)
                                   0.006542
                                     31.2
                            Adults (50+ years old)
                                   0.006583
                                     31.3
                           Females (13-49 years old)
                                   0.006365
                                     30.3

The results of the risk assessment show that for all populations the exposures are below a level of concern (< 100% cPAD).  Additional refinements in the dietary risk assessment (i.e. utilizing anticipated residue values, percent crop treated values) would further reduce the estimated exposure values.

	ii. Drinking water. The consumption of fluxapyroxad (BAS 700 F) residues in drinking water was included in the dietary assessments above. For drinking water all fluxapyroxad uses were examined at maximum use rates, maximum number of applications, and all proposed application methods to determine which use would result in the highest water concentrations. The highest acute Estimated Drinking Water Concentrations (EDWC) was estimated to be 203 ug/L (ppb).  The highest chronic EDWC's for fluxapyroxad (BAS 700 F) were estimated to be 188 ug/L (ppb).

	2. Non-dietary exposure. EPA conducted a residential exposure and risk assessment for the residential use of fluxapyroxad products for disease control in turf (April 8, 2021, DP Barcode D457531). Because no dermal hazard of concern was identified for fluxapyroxad, only inhalation exposure was assessed for residential handlers, and incidental ingestion was assessed for activities of children on treated turf. In all exposure scenarios, the MOEs for residential use of fluxapyroxad were well above EPA's level of concern (MOE < 100) indicating that these exposures are not of concern.

Short-Term Aggregate Exposure and Risk (food, water, and residential)
Short-term aggregate risk assessment includes exposure from food, water, and residential uses.  The residential uses of fluxapyroxad may result in short-term exposure, which is aggregated with the chronic dietary (food and water) exposure.  Because no dermal hazard of concern was identified for fluxapyroxad only inhalation exposure was assessed for residential handlers, and incidental oral exposure (hand to mouth) was assessed for activities of children on treated turf.

The short-term oral NOAEL is 7.3 mg/kg bw/day.  The short-term aggregate risk assessment is presented in Table 5 using dietary exposures estimated with DEEM-FCID, and in Table 6 using dietary exposures estimated with CARES NG[(R)].

 Table 5:  Short-Term Aggregate Exposure and Risk for Fluxapyroxad
                                Sub-Populations
                             Short-term Aggregate

                     Food + water exposure*
(mg/kg bw/day)
                      Residential exposure (mg/kg bw/day)
                         Total exposure (mg/kg bw/day)
                                 Aggregate MOE
                                 US Population
                                   0.006956
                                   0.000044
                                   0.0070000
                                     1043
                            Children 1-2 years old
                                   0.014496
                                    0.0035
                                   0.0179960
                                      406
* Dietary exposure calculated using DEEM-FCID ver. 4.02

 Table 6:  Short-Term Aggregate Exposure and Risk for Fluxapyroxad
                                Sub-Populations
                             Short-term Aggregate

                    Food + water exposure**
(mg/kg bw/day)
                      Residential exposure (mg/kg bw/day)
                         Total exposure (mg/kg bw/day)
                                 Aggregate MOE
                                 US Population
                                   0.007081
                                   0.000044
                                   0.0071250
                                     1025
                            Children 1-2 years old
                                   0.014795
                                    0.0035
                                   0.0182950
                                      399
** Dietary exposure calculated using CARES NG[(R)] ver. 1.2.1

The aggregate MOEs for dietary (food + water) and residential exposures are 399 to 406 for children and 1025 to 1043 for adults.  These MOEs indicate that aggregate risk from the use of fluxapyroxad is not a concern.

D. Cumulative Effects

	Section 408(b)(2)(D)(v) 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." Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to fluxapyroxad. For the purposes of this tolerance action, therefore, BASF has not assumed that fluxapyroxad has a common mechanism of toxicity with other substances.

E. Safety Determination

	1. U.S. population. Based on this risk assessment, BASF concludes that the aggregate exposure to fluxapyroxad from the current tolerances and proposed new tolerances does not result in an unacceptable risk.

	2. Infants and children. Based on this risk assessment, BASF concludes that the aggregate exposure to fluxapyroxad from the current tolerances and proposed new tolerances does not result in an unacceptable risk.

F. International Tolerances

	European Maximum Residue Limits (MRL) were established for fluxapyroxad on multiple crops in:
- March 2016 [Commission Regulation (EU) No 2016/486 of 29 March 2016; MRLs for fluxapyroxad (BAS 700 F) in various commodities of plant and animal origin. EFSA Journal 2015; 13(9):4223 [25 pp.]
- October 2016 [Commission Regulation (EU) No 2016/1902 of 27 October 2016; MRLs for fluxapyroxad (BAS 700 F) in various commodities of plant and animal origin. EFSA Journal 2016; 14(3):4004 [28 pp.]
- March 2017 [Commission Regulation (EU) No 2017/626 of 31 March 2017; MRLs for fluxapyroxad (BAS 700 F) in various commodities of plant and animal origin. EFSA Journal 2015;13(7):4208 [178 pp.] and 2016;14(8):4571 [166 pp.].
- May 2018 [Commission Regulation (EU) No 2018/685 of 3 May 2018; MRLs for fluxapyroxad (BAS 700 F) in various commodities of plant and animal origin. EFSA Journal 2017; 15(9):4975 [30 pp.]

      CODEX maximum residue levels were proposed for residues of fluxapyroxad (BAS 700 F) in/on raw agricultural commodities and processed fractions by the 2016 and 2019 Joint Meeting on Pesticide Residues (JMPR) and approved by the Codex Committee on Pesticide Residues (CCPR 48 and 51) in May 2016 (Summary Report from the 2016 Joint FAO/WHO Meeting on Pesticide Residues (JMPR), July 2016) and May 2019 (Summary Report from the 2019 Joint FAO/WHO Meeting on Pesticide Residues (JMPR), July 2019.)  The following CODEX MRLs have been established, but do not have a corresponding EPA tolerance:

  Crop
  Codex MRL (ppm)
   Bayberry
   7
   Bean, dwarf
   2
   Bean, flageolet
   2
   Bean, French
   2
   Bean, haricot
   2
   Bilberry, Bog
   7
   Buffaloberry
   7
   Cabbage, savoy
   2
   Chokecherry
   3
   Hemp seed
   0.8
   Mulberry
   7
   Persimmon, Japanese
   0.9
   Riberry
   7
   Serviceberry
   7
   Strawberries, Wild
   7
   Wasabi, leaves
   4

      Health Canada Pest Management Regulatory Agency (PMRA) has published Maximum Residue Limits (MRL) for fluxapyroxad residues on multiple crop commodities at February 02, 2016 and June 01, 2017. A complete list can be found on the Maximum Residue Limits for Pesticides webpage in the Pesticides and Pest Management section of Health Canada's website.

      The Australian Pesticides and Veterinary Medicines Authority (APVMA) has published Maximum Residue Limits (MRL) for fluxapyroxad residues on multiple crop commodities at May 4, 2018 in Australia. The Food Standards Australia New Zealand also proposed Maximum residue limits on multiple crop commodities at March 13, 2018.


[Federal Register Volume 77, Number 64 (Tuesday, April 3, 2012)]
[Rules and Regulations]
[Pages 19927-19928]
[FR Doc No: 2012-7933]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-1314; Airspace Docket No. 11-AWP-18]

Amendment of Class E Airspace; Willcox, AZ, and Revocation of
Class E Airspace; Cochise, AZ

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action modifies Class E airspace at Willcox, AZ, and
removes Class E airspace at Cochise, AZ. The airspace designation
listed as Cochise, AZ, is combined with Cochise County Airport,
Willcox, AZ. Controlled airspace is necessary to accommodate aircraft
using Area Navigation (RNAV) Global Positioning System (GPS) standard
instrument approach procedures at Cochise County Airport, Willcox, AZ.
Decommissioning of the Cochise VHF Omni-Directional Radio Range
Tactical Air Navigation Aid (VORTAC) has made this action necessary for
the safety and management of aircraft operations at the airport.

DATES: Effective date, 0901 UTC, May 31, 2012. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On January 10, 2012, the FAA published in the Federal Register a
notice of proposed rulemaking to amend controlled airspace at Willcox,
AZ, and remove the controlled airspace designation at Cochise, AZ (77
FR 1428). Interested parties were invited to participate in this
rulemaking effort by submitting written comments on the proposal to the
FAA. One comment was

received. The commenter agreed with the airspace change but was
concerned about the increased air traffic. This airspace amendment will
not increase the air traffic at Cochise County Airport. The Cochise, AZ
airspace designation is merely being incorporated into the existing
Willcox, AZ airspace designation.
    Class E airspace designations are published in paragraph 6005, of
FAA Order 7400.9V dated August 9, 2011, and effective September 15,
2011, which is incorporated by reference in 14 CFR Part 71.1. The Class
E airspace designations listed in this document will be published
subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by modifying Class E airspace extending upward from 700 feet
above the surface, at Cochise County Airport, Willcox, AZ. Controlled
airspace is necessary to accommodate IFR aircraft executing RNAV (GPS)
standard instrument approach procedures at the airport. This action
removes the Cochise, AZ airspace designation extending upward from
1,200 feet above the surface and combines it with the existing Cochise
County Airport, Willcox, AZ, designation. Decommissioning of the
Cochise VORTAC has made this action necessary, and enhances the safety
and management of aircraft operations within the National Airspace
System.
    The FAA has determined this regulation only involves an established
body of technical regulations for which frequent and routine amendments
are necessary to keep them operationally current. Therefore, this
regulation: (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. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. The FAA's authority to
issue rules regarding aviation safety is found in Title 49 of the U.S.
Code. Subtitle 1, Section 106 discusses the authority of the FAA
Administrator. Subtitle VII, Aviation Programs, describes in more
detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it modifies
controlled airspace at Cochise County Airport, Willcox, AZ, and removes
the airspace designation for the Cochise, AZ VORTAC.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR part 71.1 of the Federal
Aviation Administration Order 7400.9V, Airspace Designations and
Reporting Points, dated August 9, 2011, and effective September 15,
2011 is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AWP AZ E5 Willcox, AZ [Modified]

Cochise County Airport, AZ
    (Lat. 32[deg]14'44'' N., long. 109[deg]53'41'' W.)

    That airspace extending upward from 700 feet above the surface
within 6.5-mile radius of the Cochise County Airport and within 5
miles each side of the 225[deg] bearing of the Cochise County
Airport extending from the 6.5-mile radius to 14.5 miles southwest
of the airport, and within 5.5 miles southeast and 4.5 miles
northwest of the 055[deg] bearing of the Cochise County Airport
extending from the 6.5-mile radius to 14.5 miles northeast of the
airport. That airspace extending upward from 1,200 feet above the
surface bounded by a line beginning at lat. 32[deg]22'30'' N., long.
110[deg]00'02'' W.; to lat. 32[deg]22'00'' N., long. 109[deg]57'30''
W.; to lat. 32[deg]30'00'' N., long. 109[deg]54'00'' W.; to lat.
32[deg]22'40'' N., long. 109[deg]25'00'' W.; to lat. 32[deg]15'30''
N., long. 109[deg]27'30'' W.; to lat. 32[deg]14'25'' N., long.
109[deg]25'22'' W.; to lat. 32[deg]10'20'' N., long. 109[deg]25'22''
W.; to lat. 32[deg]10'20'' N., and the Arizona/New Mexico border,
thence south along the Arizona/New Mexico border to lat.
31[deg]52'40'' N.; to lat. 31[deg]54'00'' N., long. 109[deg]25'27''
W.; to lat. 31[deg]57'05'' N., long. 109[deg]55'02'' W.; to lat.
32[deg]07'00'' N., long. 109[deg]54'02'' W.; to lat. 32[deg]07'30''
N., long. 110[deg]00'02'' W., thence to the point of beginning.

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AWP AZ E5 Cochise, AZ [Removed]

    Issued in Seattle, Washington, on March 26, 2012.
Robert Henry,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2012-7933 Filed 4-2-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 125 (Friday, June 30, 2017)]
[Notices]
[Page 29860]
[FR Doc No: 2017-13663]

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ENVIRONMENTAL PROTECTION AGENCY

[9963-90-OEI]

Cross-Media Electronic Reporting: Authorized Program Revision
Approval, State of Idaho

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's approval of the State of Idaho's
request to revise its National Primary Drinking Water Regulations
Implementation EPA-authorized program to allow electronic reporting.

DATES: EPA's approval is effective July 31, 2017 for the State of
Idaho's National Primary Drinking Water Regulations Implementation
program, if no timely request for a public hearing is received and
accepted by the Agency.

FOR FURTHER INFORMATION CONTACT: Karen Seeh, U.S. Environmental
Protection Agency, Office of Environmental Information, Mail Stop
2823T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 566-
1175<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On October 13, 2005, the final Cross-Media
Electronic Reporting Rule (CROMERR) was published in the Federal
Register (70 FR 59848) and codified as part 3 of title 40 of the CFR.
CROMERR establishes electronic reporting as an acceptable regulatory
alternative to paper reporting and establishes requirements to assure
that electronic documents are as legally dependable as their paper
counterparts. Subpart D of CROMERR requires that state, tribal or local
government agencies that receive, or wish to begin receiving,
electronic reports under their EPA-authorized programs must apply to
EPA for a revision or modification of those programs and obtain EPA
approval. Subpart D provides standards for such approvals based on
consideration of the electronic document receiving systems that the
state, tribe, or local government will use to implement the electronic
reporting. Additionally, Sec.  3.1000(b) through (e) of 40 CFR part 3,
subpart D provides special procedures for program revisions and
modifications to allow electronic reporting, to be used at the option
of the state, tribe or local government in place of procedures
available under existing program-specific authorization regulations. An
application submitted under the subpart D procedures must show that the
state, tribe or local government has sufficient legal authority to
implement the electronic reporting components of the programs covered
by the application and will use electronic document receiving systems
that meet the applicable subpart D requirements.
    On May 5, 2017, the Idaho Department of Environmental Quality
(IDEQ) submitted an application titled Compliance Monitoring Data
Portal for revision to its EPA-approved drinking water program under
title 40 CFR to allow new electronic reporting. EPA reviewed IDEQ's
request to revise its EPA-authorized program and, based on this review,
EPA determined that the application met the standards for approval of
authorized program revision set out in 40 CFR part 3, subpart D. In
accordance with 40 CFR 3.1000(d), this notice of EPA's decision to
approve Idaho's request to revise its Part 142--National Primary
Drinking Water Regulations Implementation program to allow electronic
reporting under 40 CFR part 141 is being published in the Federal
Register.
    IDEQ was notified of EPA's determination to approve its application
with respect to the authorized program listed above.
    Also, in today's notice, EPA is informing interested persons that
they may request a public hearing on EPA's action to approve the State
of Idaho's request to revise its authorized public water system program
under 40 CFR part 142, in accordance with 40 CFR 3.1000(f). Requests
for a hearing must be submitted to EPA within 30 days of publication of
today's Federal Register notice. Such requests should include the
following information:
    (1) The name, address and telephone number of the individual,
organization or other entity requesting a hearing;
    (2) a brief statement of the requesting person's interest in EPA's
determination, a brief explanation as to why EPA should hold a hearing,
and any other information that the requesting person wants EPA to
consider when determining whether to grant the request;
    (3) the signature of the individual making the request, or, if the
request is made on behalf of an organization or other entity, the
signature of a responsible official of the organization or other
entity.
    In the event a hearing is requested and granted, EPA will provide
notice of the hearing in the Federal Register not less than 15 days
prior to the scheduled hearing date. Frivolous or insubstantial
requests for hearing may be denied by EPA. Following such a public
hearing, EPA will review the record of the hearing and issue an order
either affirming today's determination or rescinding such
determination. If no timely request for a hearing is received and
granted, EPA's approval of the State of Idaho's request to revise its
part 142--National Primary Drinking Water Regulations Implementation
program to allow electronic reporting will become effective 30 days
after today's notice is published, pursuant to CROMERR section
3.1000(f)(4).

Matthew Leopard,
Director, Office of Information Management.
[FR Doc. 2017-13663 Filed 6-29-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 75, Number 217 (Wednesday, November 10, 2010)]
[Proposed Rules]
[Pages 69036-69037]
[FR Doc No: 2010-28259]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 58

[EPA-HQ-OAR-2008-0338; FRL-9223-6]

Notice of Data Availability Regarding Potential Changes to
Required Ozone Monitoring Seasons for Colorado, Kansas, and Utah

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Data Availability (NODA).

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SUMMARY: The EPA is providing notice that it is supplementing the
record to the Proposed Rule--Ambient Ozone Monitoring Regulations:
Revisions to Network Design Requirements, published July 16, 2009. The
EPA has placed in the docket for the Proposed Rule--Ambient Ozone
Monitoring Regulations: Revisions to Network Design Requirements
(Docket ID No. EPA-HQ-OAR-2008-0338) additional ambient ozone
monitoring data for the period January 1, 2007, through April 30, 2010,
for the states of Colorado, Kansas, and Utah that cover time periods
outside of the current required ozone monitoring seasons. The data for
these states consist of daily maximum 8-hour ozone concentrations.
These data have become available since original analyses were completed
for the proposal, which relied on ambient data covering the period
2004-2006. EPA is specifically considering how these more recent data
could impact changes to the current and proposed required ozone
monitoring seasons for Colorado, Kansas, and Utah.

DATES: Comments must be received on or before December 10, 2010. Please
refer to SUPPLEMENTARY INFORMATION for additional information on
submitting comments.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2008-0338, by one of the following methods:
     http://www.regulations.gov. Follow the on-line
instructions for submitting comments. Attention Docket ID No. EPA-HQ-
OAR-2008-0338.
     Fax:<PHONE_NUMBER>.
     Mail: EPA Docket Center, EPA West (Air Docket), Attention
Docket ID No. EPA-HQ-OAR-2008-0338, U.S. Environmental Protection
Agency, Mailcode: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC
20460. Please include 2 copies.
     Hand Delivery: U.S. Environmental Protection Agency, EPA
West (Air Docket), 1301 Constitution Avenue, NW., Room 3334,
Washington, DC 20004, Attention Docket ID No. EPA-HQ-OAR-2008-0338.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2008-0338. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Air and Radiation
Docket and Information Center, EPA/DC, EPA East Building Room 3334,
1301 Constitution Ave., NW., Washington, DC. 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
(202) 566-1744, and the telephone number for the Air Docket is (202)
566-1742.

FOR FURTHER INFORMATION CONTACT: For questions regarding the additional
ambient ozone data, contact Lewis Weinstock, Air Quality Assessment
Division/Ambient Air Monitoring Group (C304-06), Research Triangle
Park, NC 27711; telephone number:<PHONE_NUMBER>; fax number: 919-541-
1903; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Outline

1. What is the purpose for this action?
2. What information is EPA making available for review and comment?
3. How does this information relate to the Proposed Rule--Ambient
Ozone Monitoring Regulations: Revisions to Network Design
Requirements?
4. Where can I get this information?
5. What issue is EPA taking comment on?
6. What should I consider as I prepare my comments for EPA?
7. Submitting Confidential Business Information (CBI)

1. What is the purpose for this action?

    This NODA provides for public review and comment on ambient ozone
monitoring data for the period January 1, 2007, through April 30, 2010,
for the states of Colorado, Kansas, and Utah.

2. What information is EPA making available for review and comment?

    EPA is making available for review and comment ozone monitoring
data for the states of Colorado, Kansas, and Utah that were obtained
during the months outside of the current ozone monitoring seasons
required by 40 CFR part 58, Appendix D, Table D-3. The data include a
listing of days when ozone concentrations reached an 8-hour average
level of at least 0.060 parts per million (ppm) during the following
months: Colorado (January, February, October, November, December);
Kansas (January, February, March, November, December); and Utah
(January, February, March, April, October, November, December). These
data were obtained from EPA's Air Quality System (AQS) and represent
data from monitors

utilizing approved Federal Equivalent Methods.

3. How does this information relate to the Proposed Rule--Ambient Ozone
Monitoring Regulations: Revisions to Network Design Requirements?

    On July 16, 2009, EPA published a proposed rule (74 FR 34525) to
revise the ozone monitoring network design requirements. EPA proposed
to modify minimum monitoring requirements in urban areas, add new
minimum monitoring requirements in non-urban areas, and to extend the
length of the required ozone monitoring season in some states.
    In its proposal, EPA used ambient ozone monitoring data obtained
from monitors operating outside (i.e., before and after) the current
required ozone monitoring season to assess whether ambient ozone
concentrations could approach or exceed the level of the primary (8-
hour) National Ambient Air Quality Standards (NAAQS) during these
periods when monitoring is not currently required. EPA's analysis
utilized data for the period 2004-2006, representing data from
approximately 530 monitors which were operated on a year-round basis.
These data were analyzed for two indicators: (1) The number of
exceedences of the NAAQS (i.e., daily maximum 8-hour ozone averages
above 0.075 ppm) in the months falling outside the currently required
ozone monitoring season for each area, and (2) occurrences of daily
maximum 8-hour ozone averages of at least 0.060 ppm, representing a
value of 80 percent of the 0.075 ppm NAAQS. In the proposal, we noted
that the operation of ozone monitors during such periods of time when
ambient levels reach at least 80 percent of the NAAQS ensures that
persons unusually sensitive to ozone are alerted to the occurrence of
elevated ozone concentrations in their area, and protects against the
potential for undocumented NAAQS exceedances. The availability of these
additional data support many objectives including more comprehensive
real-time air quality reporting to the public, ozone forecasting
programs, and the verification of real-time air quality forecast
models.
    As EPA completes revised analyses to support the upcoming ozone
monitoring final rule, certain patterns of out-of-season elevated 8-
hour average ozone concentrations, which were not recognizable during
2004-2006, have become apparent in newer data. These patterns include a
greater frequency of occurrences of daily maximum 8-hour ozone averages
of at least 0.060 ppm before and after the currently required ozone
monitoring seasons for the aforementioned states than was observed in
the 2004-2006 dataset. Accordingly, EPA is making these newer data
available for the specific states that have such patterns.

4. Where can I get this information?

    All of the information can be obtained through the Air Docket and
at http://www.regulations.gov (see ADDRESSES section above for docket
contact information).

5. What issue is EPA taking comment on?

    EPA requests comment on the interpretation of the newer ambient 8-
hour average ozone monitoring data for the states of Colorado, Kansas,
and Utah in the context of determining the final ozone monitoring
season requirements for these states. Specifically, do the patterns of
elevated 8-hour average ozone concentrations that occurred both before
and after the current required ozone monitoring seasons for these
states support the revised seasons proposed in the July 16, 2009,
rulemaking for these states? Do these patterns support alternative
required monitoring seasons different from what was proposed in the
July 16, 2009, rulemaking for these states? Issues for consideration
with regard to Colorado, Kansas, and Utah are whether the current ozone
season requirements should be maintained, whether the proposed changes
to seasons should be finalized as proposed or revised, and whether
changes should be made for these states that were not originally
proposed in the July 2009 rule.

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

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide any technical information or data you used that support
your views.
    4. Provide specific examples to illustrate your concerns.
    5. Offer alternatives.
    6. Make sure to submit your comments by the comment period deadline
identified.
    7. To ensure proper receipt by EPA, identify the appropriate docket
identification number in the subject line on the first page of your
response. It would also be helpful if you provided the name, date, and
Federal Register citation related to your comments.

7. Submitting Confidential Business Information (CBI)

    Do not submit information you are claiming as CBI to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part of the
information that you claim to be CBI. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2. For CBI information in a disk or CD-ROM that you mail to EPA, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket.

List of Subjects in 40 CFR Part 58

    Air pollution control, Environmental protection, Intergovernmental
relations, Reporting and recordkeeping requirements, Ambient air
monitoring.

    Dated: November 3, 2010.
Mary E. Henigin,
Acting Director, Office of Air Quality Planning and Standards.
[FR Doc. 2010-28259 Filed 11-9-10; 8:45 am]
BILLING CODE 6560-50-P