[Federal Register Volume 80, Number 75 (Monday, April 20, 2015)]
[Notices]
[Pages 21778-21782]
[FR Doc No: 2015-08941]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74725; File No. SR-NASDAQ-2015-032]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend NASDAQ Rules 7014 and 7018

April 14, 2015.
    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 1, 2015, 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 and
II below, which Items have been prepared by the Exchange. 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.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    NASDAQ is proposing changes to the Qualified Market Maker (``QMM'')
Incentive Program under Rule 7014, and the qualification requirements
for certain fees relating to Market-on-Close and/or Limit-on-Close
orders under Rule 7018(a).
    The text of the proposed rule change is available at
nasdaq.cchwallstreet.com at NASDAQ's principal office, 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, NASDAQ 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 those 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
    NASDAQ is proposing to amend Rule 7014(d), which provides the
qualification criteria for designation as a Qualified Market Maker
(``QMM'') under the QMM incentive program, to limit qualification to
registered NASDAQ market makers (``Market Makers''). Currently, a QMM
may be, but is not required to be, a Market Maker in any security.\3\
The QMM program provides incentives to a member firm to make a
significant contribution to market quality by providing liquidity at
the NBBO in a large number of stocks for a significant portion of the
day. In addition, the member must avoid imposing the burdens on NASDAQ
and its market participants that may be associated with excessive rates
of entry of orders away from the inside and/or order cancellation. The
Exchange notes that the program, to date, has been used very little by
member firms that are not Market Makers, and only Market Makers use the
program at this time. Accordingly, the Exchange is proposing to amend
Rule 7014(d)(3) to limit the program to Market Makers. The Exchange is
also deleting the current qualification criteria under Rule 7014(d)(3)
that requires a member firm to have liquidity provided in all
securities through one of its NASDAQ Market Center MPIDs that represent
0.30% of Consolidated Volume during the month. The Exchange notes that
the Consolidated Volume requirement is superfluous given that it is
adopting Consolidated Volume eligibility criteria for the credits under
the QMM program, and is adding an absolute Consolidated Volume
eligibility criteria to receive the reduced removal rate under the
program, as discussed below.
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    \3\ Thus, the QMM designation does not by itself impose a two-
sided quotation obligation or convey any of the benefits associated
with being a registered market maker.
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    NASDAQ is amending Rule 7014(e), which sets forth the criteria
required to receive the benefits of the program, to move the two
credits provided under subparagraphs (1) and (2) provided for
executions in securities listed on NYSE (``Tape A'') and securities
listed on exchanges other than NASDAQ and NYSE (``Tape B'') to a table
format directly under Rule 7014(e). NASDAQ is also modifying the
criteria a QMM must meet to receive the two tiers of credits under the
rule. Currently, NASDAQ provides a rebate of $0.0002 per share executed
(in addition to other credits received under Rule 7018(a)) with respect
to orders that are executed at a price of $1 or more and (A) displayed
a quantity of at least one round lot at the time of execution; (B)
either established the NBBO or was the first order posted on NASDAQ
that had the same price as an order posted at another trading center
with a protected quotation that established the NBBO; (C) were entered
through a QMM MPID; (D) were for securities listed on NYSE or
securities listed on exchanges other than NASDAQ and NYSE and (E) that
no additional rebate will be issued with respect to Designated Retail
Orders (as defined in Rule 7018). NASDAQ is proposing to replace these
requirements with a new requirement that a QMM execute shares of
liquidity provided in all securities through one or more of its NASDAQ
Market Center MPIDs that represent greater than 0.90% of Consolidated
Volume during the month. The Exchange is replacing the current
requirements, which provide the QMM with an incentive to provide
displayed liquidity that sets the NBBO on NASDAQ, with a new
requirement to provide a significant level Consolidated Volume in all
securities through one or more of its MPIDs. Consolidated Volume is
defined by Rule 7018(a) as the total consolidated volume reported to
all consolidated transaction reporting plans by all exchanges and trade
reporting facilities during a month in equity securities, excluding
executed orders with a size of less than one round lot.\4\ The Exchange
believes that tying the rebate to the provision of greater overall
volume will provide an increased impact to improving market quality
over the current NBBO-based criteria.
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    \4\ For purposes of calculating Consolidated Volume and the
extent of a member's trading activity, expressed as a percentage of
or ratio to Consolidated Volume, the date of the annual
reconstitution of the Russell Investments Indexes shall be excluded
from both total Consolidated Volume and the member's trading
activity.
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    Similarly, the Exchange is proposing to modify the requirements to
receive a rebate of $0.0001 per share executed under Rule 7014(e)(2).
Currently, a QMM will receive the rebate with respect to all other
displayed orders (other than Designated Retail Orders, as defined in
Rule 7018) in securities priced at $1 or more per share that provide
liquidity that are entered through a QMM MPID in Tape A or B
securities. The Exchange is proposing to now require that a QMM execute
shares of liquidity provided in all securities through one or more of
its Nasdaq Market Center MPIDs that represent from 0.70% up to and
including 0.90% of Consolidated Volume during the month. The Exchange
believes that tying the rebate to the provision of greater overall
volume will provide an increased impact to improving market quality
over the current requirement that the orders are displayed and provide
liquidity.
    As a consequence of moving and modifying the criteria of Rules
7014(e)(1) and (2), NASDAQ is moving certain rule text concerning the
type of securities that the rule applies to, and certain exclusions
from the program, from subparagraphs (1) and (2) to the first paragraph
of Rule 7014(e). As noted above, NASDAQ is placing the two credits
provided under subparagraphs (1) and (2) in a table format and,
consequently, is deleting those subparagraphs. NASDAQ is moving
language, which is repeated in both subparagraphs, that notes the
credits provided apply to securities priced at $1 or more per share to
the new table under Rule 7014(e) where the two credits are now located.
The Exchange is also moving text that concerns exclusion of Designated
Retail Orders from subparagraphs (1) and (2) to directly above the new
table under Rule 7014(e).
    NASDAQ is proposing to amend the criteria under Rule 7014(e)(3)
required to receive the reduced remove rate fee of $0.00295 per share
executed under the rule in Tape A and B securities priced at $1 or more
for shares executed via its QMM MPID. Currently, NASDAQ will charge a
fee of $0.0030 per share executed for orders in securities listed on
NASDAQ (``Tape C'') priced at $1 or more per share that access
liquidity on the NASDAQ Market Center and that are entered through a
QMM MPID, and charges a fee of $0.00295 per share executed for orders
in Tape A or B securities priced at $1 or more per share that access
liquidity on the NASDAQ Market Center and that are entered through a
QMM MPID; provided, however, that after the first month in which an
MPID becomes a QMM MPID, the QMM's volume of liquidity added, provided,
and/or routed through the QMM MPID during the month (as a percentage of
Consolidated Volume) must not be less than 0.05% lower than the volume
of liquidity added, provided, and/or routed through such QMM MPID
during the first month in which the MPID qualified as a QMM MPID (as a
percentage of Consolidated Volume). NASDAQ is proposing to eliminate
the current Consolidated Volume requirement, which relates to

the first month in which an MPID qualified as a QMM MPID, and now
require that the QMM executes shares of liquidity provided in all
securities through one or more of its NASDAQ Market Center MPIDs of
0.80% or more of Consolidated Volume during the month. The Exchange
believes that the changes will tie receipt of the reduced removal fee
in Tape A and B securities to a more meaningful measure of market-
improvement. Decoupling the measure from the QMM's first month QMM
Consolidated Volume will ensure that all QMMs meet a minimum standard
that is uniform. Increasing the Consolidated Volume required to receive
the fee will provide incentive to QMMs to provide greater market-
improving participation in return for the benefit.
    The Exchange is also proposing to increase the level of
Consolidated Volume that a member firm must have in Market-on-Close
and/or Limit-on-Close orders during the month in order to qualify for
fees to remove liquidity in securities executed at or above $1 under
Rule 7018(a)(1), (2) and (3). Currently, NASDAQ assesses a fee for
member firms that qualify based on their Market-on-Close and/or Limit-
on-Close order participation in the Closing Cross of $0.0030 per share
executed in Tape C securities under Rule 7018(a)(1), and fees of
$0.00295 per share executed in Tape A and B securities under Rules
7018(a)(2) and (3), respectively. To qualify under each of the rules, a
member firm must have Market-on-Close and/or Limit-on-Close orders
executed in the NASDAQ Closing Cross, entered through a single NASDAQ
Market Center market participant identifier, that represent more than
0.06% of Consolidated Volume during the month. The Exchange is
proposing to increase the minimum level of Consolidated Volume required
under each of the rules to 0.15%.
2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\5\ in general, and with
Sections 6(b)(4) and 6(b)(5) of the Act,\6\ in particular, in that it
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 not
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
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    \5\ 15 U.S.C. 78f.
    \6\ 15 U.S.C. 78f(b)(4) and (5).
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    NASDAQ believes that the proposed changes to the QMM program in
NASDAQ Rule 7014(d)(3) is [sic] reasonable and will not discriminate
unfairly because they refine the program to focus on market
participants who currently use the program. As discussed above, Market
Makers have provided the vast majority of participation in the program
and are currently the only market participant utilizing the program.
Accordingly, restricting the program to Market Makers will not result
in a material change in who participates in the program. Additionally,
Market Makers have both obligations to the market and regulatory
requirements that normally do not apply to other market participants.
As such, the Exchange believes that providing additional incentives to
Market Makers to provide liquidity for the benefit of all investors and
other market participants is reasonable and not unfairly
discriminatory. The proposed modifications to the QMM program recognize
the benefits of increased Market Maker participation and the Exchange
believes that this proposal will improve displayed liquidity, and thus
the execution quality overall on the Exchange. Moreover, the Exchange
believes that eliminating the current Consolidated Volume requirement
is reasonable and not unfairly discriminatory because it will become
superfluous in light of additional requirements based on Consolidated
Volume that are also being proposed herein. For the same reasons noted
above, limiting eligibility in the program to Market Makers and
eliminating the Consolidated Volume requirement under Rule 7014(d)(3)
is an equitable allocation of the fees and credits provided by the
program. In this regard, no current participants in the program will be
excluded from being eligible to participate after the proposed change
is effective, and applying the current Consolidated Volume criteria
will have no significance in light of the proposed changes to the
specific fees and credits under the program.
    The Exchange believes that the proposed changes to Rule 7014(e) are
reasonable and not unfairly discriminatory because they impose stricter
requirements on Market Makers to receive the benefits of the program,
which will be applied uniformly to all Market Makers that are eligible
to participate in the QMM program. With regard to the $0.0002 rebate
provided in Tape A and B securities, the Exchange is eliminating the
NBBO-based criteria and tying the rebate to greater overall volume,
which the Exchange believes will provide a greater impact to improving
overall market quality because the economic benefits provided to the
Market Maker are more certain and therefore provide the Market Maker a
means to more aggressively provide displayed liquidity to the Exchange
for the benefit of all market participants. In this regard, the
Exchange notes that Market Makers must provide more than 0.90% of
Consolidated Volume during the month, which is a significant level
participation in the market. Similarly, NASDAQ is proposing a
significant level of Consolidated Volume to receive the $0.0001 rebate
under the rule, which currently only requires that the QMM participant
provide displayed liquidity. The Exchange believes that it is
reasonable and not unfairly discriminatory to impose stricter criteria
designed to improve market quality in return for the credit NASDAQ
elects to provide. NASDAQ also believes that the proposed changes to
the eligibility requirements for the reduced removal fee in Tape A and
B securities of $0.00295 per share executed are reasonable and not
unfairly discriminatory because they increase the level of Consolidated
Volume required, which will be an absolute requirement and not tied to
historical levels of Consolidated Volume, thereby increasing the level
of market improvement necessary to receive the reduced rate. As an
absolute requirement, the Consolidated Volume requirement will apply
uniformly to all Market Makers eligible to participate in the program.
The Exchange believes that the proposed changes to the eligibility
requirements under Rule 7014(e) are an equitable allocation because
NASDAQ will provide the same rebates and fees to all Market Makers that
qualify under the rule.
    Lastly, NASDAQ notes that Market Makers serve an important role on
the Exchange with regard to order interaction and provide continuous,
passive liquidity in the marketplace. Additionally, Market Makers incur
costs unlike the majority of other market participants including, but
not limited to, their own infrastructure and other technology costs
associated with market making activities. Consequently, the proposed
differentiation between Market Makers and other market participants
recognizes the differing contributions made to the quality of the
market on the Exchange by Market Makers and the heightened regulatory
requirements and costs associated with being a Market Maker. In brief,
the Exchange believes that the proposed changes to the QMM program
further

incentives registered Market Makers to provide liquidity improves
market qualify [sic], furthers the price discovery process and benefits
investors.
    The Exchange believes that the proposed changes to the level of
Consolidated Volume in Market-on-Close and/or Limit-on-Close order
participation in the Closing Cross required to receive the fees for
orders that remove liquidity under Rules 7018(a)(1), (2), and (3) are
reasonable and not unfairly discriminatory because they represent an
increase in the level of market-improving Consolidated Volume
contributed to the Closing Cross. NASDAQ provides discounted fees in
Market-on-Close and/or Limit-on-Close orders in Tape A and B securities
to provide incentives to member firms to provide liquidity in the
closing process. NASDAQ is increasing the Consolidated Volume
requirement to better align the discounted remove fees with members
that use the closing cross process more regulatory [sic] over
alternatives and also access liquidity more frequently on the Exchange
as opposed to other members. Nonetheless, NASDAQ believes that it is
reasonable and not unfairly discriminatory to change the eligibility
criteria so that it mirrors the eligibility criteria of the related
fees under Rules 7018(a)(2) and (3). Lastly, the Exchange believes that
the proposed changes to the rules are an equitable allocation of the
fees because the fee is provided uniformly to all member firms that
qualify for the fees and all member firms have an equal opportunity to
earn the discounted fee for accessing liquidity.

B. Self-Regulatory Organization's Statement on Burden on Competition

    NASDAQ does not believe that the proposed rule changes will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.\7\ NASDAQ notes
that it operates in a highly competitive market in which market
participants can readily favor competing venues if they deem fee levels
at a particular venue to be excessive, or rebate opportunities
available at other venues to be more favorable. In such an environment,
NASDAQ must continually adjust its fees to remain competitive with
other exchanges and with alternative trading systems that have been
exempted from compliance with the statutory standards applicable to
exchanges. Because competitors are free to modify their own fees in
response, and because market participants may readily adjust their
order routing practices, NASDAQ believes that the degree to which fee
changes in this market may impose any burden on competition is
extremely limited or even non-existent. In this instance, the changes
to eligibility criteria required to receive credits and reduced fees
under the QMM program do not impose a burden on competition because the
incentive program remains in place, still offers economically
advantageous credits and reduced fees, and is reflective of the need
for exchanges to offer, and to let, the financial incentives to attract
order flow evolve. While the Exchange does not believe that the
proposed changes to the QMM program will result in any burden on
competition, if the changes proposed herein are unattractive to market
participants it is likely that NASDAQ will lose market share as a
result. Similarly, the proposed changes to the eligibility criteria for
remove fees under Rule 7018(a) based on Market-on-Close and/or Limit-
on-Close order participation in the Closing Cross are designed to
increase participation in the Closing Cross by setting the minimum
level of Consolidated Volume eligibility criteria higher, thereby
improving the market at the market close. To the extent the
qualification criteria is too onerous or unattractive to market
participants, NASDAQ will likely lose order flow and participation in
the Closing Cross as a result.
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    \7\ 15 U.S.C. 78f(b)(8).
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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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\8\ 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. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
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    \8\ 15 U.S.C. 78s(b)(3)(A)(ii).
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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-NASDAQ-2015-032 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2015-032. 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
a.m. and 3 p.m. Copies of such filing also will 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-NASDAQ-2015-032, and should
be submitted on or before May 8, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2015-08941 Filed 4-17-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: July 9, 2008 (Volume 73, Number 132)]
[Rules and Regulations]
[Page 39240-39247]
[DOCID:fr09jy08-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0416; FRL-8371-9]

Azoxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of azoxystrobin (methyl (E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate) and its Z isomer (methyl (Z)-2-(2-(6-
(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) in or on
animal feed, nongrass, forage, group 18 at 45 parts per million (ppm);
animal feed, nongrass, hay, group 18 at 120 ppm; barley, forage at 25
ppm; cotton, gin byproducts at 45 ppm; cotton, undelinted seed at 0.6
ppm; grain, aspirated fractions at 420 ppm; rice, wild, grain at 5.0
ppm; sorghum, forage at 25 ppm; sorghum, grain at 11 ppm; sorghum,
stover at 40 ppm; and wheat, forage at 25 ppm. Syngenta Crop
Protection, Inc. requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA). EPA is also deleting certain
azoxystrobin tolerances that are no longer needed as a result of this
action.

DATES: This regulation is effective July 9, 2008. Objections and
requests for hearings must be received on or before September 8, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0416. To access the
electronic docket, go to http://www.regulations.gov, and search for the
docket number. All documents in the docket are listed in the docket
index available in regulations.gov. Although listed in the index, some
information is not publicly available, e.g., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and will be publicly available only in hard
copy form. Publicly available docket materials are available in the
electronic docket at http://www.regulations.gov, or, if only available
in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket Facility telephone number
is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: John Bazuin, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American

Industrial Classification System (NAICS) codes have been provided to
assist you and others in determining whether this action might apply to
certain entities. If you have any questions regarding the applicability
of this action to a particular entity, consult the person listed under
FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0416 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before September 8, 2008.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0416, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of September 28, 2007 (72 FR 55204) (FRL-
8147-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
6F7106 and 7F7198) by Syngenta Crop Protection, Inc., P.O. Box 18300,
Greensboro, NC 27409. Petition PP 6F7106 requested that 40 CFR
180.507(a)(1) be amended by establishing tolerances for combined
residues of the fungicide azoxystrobin (methyl (E)-2-(2-(6-(2-
cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) and the Z
isomer of azoxystrobin (methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate in or on barley, forage at 30 ppm; non-
grass animal feeds, forage at 35 ppm; non-grass animal feeds, hay at
100 ppm; sorghum, forage at 25 ppm; sorghum, grain at 9 ppm; sorghum,
stover at 40 ppm; and wheat, forage at 30 ppm. Petition PP 6F7106 also
requested that 40 CFR 180.507(a)(2) be amended by establishing
tolerances for residues of the fungicide azoxystrobin in or on cattle,
kidney at 1.00 ppm; cattle, liver at 5.10 ppm; cattle, meat byproducts
(except liver and kidney) at 0.07 ppm; goat, kidney at 1.00 ppm; goat,
liver at 5.10 ppm; goat, meat byproducts (except liver and kidney) at
0.07 ppm; egg, white at 0.01 ppm; egg, yolk at 0.15 ppm; hog, kidney at
0.03 ppm; hog, liver at 0.23 ppm; hog, meat byproducts (except liver
and kidney) at 0.01 ppm; horse, kidney at 1.00 ppm; horse, liver at
5.10 ppm; poultry, fat at 0.01 ppm; poultry, liver at 0.12 ppm;
poultry, meat at 0.02 ppm; sheep, kidney at 1.00 ppm; sheep, liver at
5.10 ppm; sheep, meat byproducts (except liver and kidney) at 0.07 ppm.
Petition PP 6F7106 additionally requested that 40 CFR 180.507(a)(1) be
amended by increasing the tolerance for the combined residues of the
fungicide azoxystrobin and the Z isomer of azoxystrobin in or on
aspirated grain fractions to 112 ppm; increasing the tolerances for the
residues of the fungicide azoxystrobin in or on cattle, fat to 0.13
ppm; cattle, meat to 0.07 ppm; goat, fat to 0.13 ppm; goat, meat to
0.07 ppm; hog, fat to 1.10 ppm; horse, meat to 0.07 ppm; milk to 0.05
ppm; sheep, fat to 0.13 ppm; and sheep, meat to 0.07 ppm; and leaving
the tolerance for the residues of the fungicide azoxystrobin and the Z
isomer of azoxystrobin in or on hog, meat unchanged at 0.01 ppm.
Petition PP 7F7198 requested that 40 CFR 180.507(a)(1) be amended by
establishing a permanent tolerance for combined residues of the
fungicide azoxystrobin and the Z isomer of azoxystrobin in or on rice,
wild at 5.0 ppm and by changing the tolerances for combined residues of
the fungicide azoxystrobin and the Z isomer of azoxystrobin in or on
cotton, gin byproducts to 35 ppm and cotton, undelinted seed to 0.7
ppm. That notice referenced a summary of the petition prepared by
Syngenta Crop Protection, Inc., the registrant, which is available to
the public in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA is not
modifying the tolerances for ruminant and swine raw agricultural
commodities (RACs) or establishing tolerances for poultry RACs. EPA is,
however, increasing the proposed tolerance for sorghum grain from 9 ppm
to 11 ppm, increasing the proposed tolerance for aspirated grain
fractions from 112 ppm to 420 ppm, reducing the proposed tolerances of
30 ppm for both wheat forage and barley forage to 25 ppm, reducing the
proposed tolerance for undelinted cotton seed from 0.7 to 0.6 ppm,
increasing the proposed tolerance for cotton gin byproducts from 35 to
45 ppm, increasing the proposed tolerance for non-grass animal feeds,
forage from 35 to 45 ppm, and increasing the proposed tolerance for
non-grass animal feeds, hay from 100 to 120 ppm. EPA is also revoking
the two expired time-limited tolerances for safflower, seed at 1.0 ppm;
and for Brassica, head and stem, subgroup 5A of 30 ppm in 40 CFR
180.507(b). The rice, wild tolerance in 40 CFR 180.507(b) is also being
revoked. The reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all

other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C) of
FFDCA requires EPA to give special consideration to exposure of infants
and children to the pesticide chemical residue in establishing a
tolerance and to ``ensure that there is a reasonable certainty that no
harm will result to infants and children from aggregate exposure to the
pesticide chemical residue. . . .''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for combined residues of azoxystrobin (methyl (E)-2-(2-(6-
(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) and the Z
isomer of azoxystrobin (methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate) in or on animal feed, nongrass,
forage, group 18 at 45 ppm; animal feed, nongrass, hay, group 18 at 120
ppm; barley, forage at 25 ppm; cotton, gin byproducts at 45 ppm;
cotton, undelinted seed at 0.6 ppm; grain, aspirated fractions at 420
ppm; rice, wild, grain at 5.0 ppm; sorghum, forage at 25 ppm; sorghum,
grain at 11 ppm; sorghum, stover at 40 ppm; and wheat, forage at 25
ppm. EPA's assessment of exposures and risks associated with
establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children
    Azoxystrobin has low acute toxicity via the oral, dermal and
inhalation routes of exposure. Azoxystrobin is not an eye or skin
irritant and is not a skin sensitizer. The most common toxicity
findings from administration of azoxystrobin to rats, via the oral
route, were decreased body weight, decreased food intake/utilization,
increased diarrhea, and other clinical toxicity observations such as,
increased urinary incontinence, hunched postures and distended
abdomens. There were no developmental effects in the rat and rabbit
developmental studies. In the reproduction study, decreased body
weights and increased adjusted liver weights were observed at the same
dose in both offspring and parental animals. In both the acute and
subchronic neurotoxicity studies, there were no consistent indications
of treatment-related neurotoxicity. There was no evidence of
carcinogenicity in rats and mice at acceptable dose levels.
Azoxystrobin induced a weak mutagenic response in the mouse lymphoma
assay, but the activity expressed in vitro is not expected to be
expressed in whole animals.
    Specific information on the studies received and the nature of the
adverse effects caused by azoxystrobin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule
published in the Federal Register of September 29, 2000 (65 FR 58404)
(FRL-6749-1).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for azoxystrobin used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of September 29, 2000.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to azoxystrobin, EPA considered exposure under the petitioned-
for tolerances as well as all existing azoxystrobin tolerances in (40
CFR 180.507). EPA assessed dietary exposures from azoxystrobin in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA used tolerance
level residues, a 100% crop treated assumption, and default processing
factors for all existing and proposed uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA used tolerance level
residues and default processing factors for all existing and proposed
uses. As to percent crop treated, EPA used data on the actual
percentage of crop treated for some existing uses and assumed 100% crop
treated for all proposed uses, and all other existing uses.
    iii. Cancer. The Agency has determined that azoxystrobin is not
likely to be a human carcinogen, so an exposure assessment to estimate
cancer risk is unnecessary.
    iv. Percent crop treated (PCT) information. EPA did not use
anticipated residue information in the dietary assessment for
azoxystrobin.

Tolerance level residues were assumed for all food commodities.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency used PCT information as follows: Acerola - 100%; almond
- 20%; amaranth, leafy - 100%; apricot - 15%; arrowroot - 100%;
artichoke, globe - 100%; artichoke, Jerusalem - 100%; arugula - 100%;
asparagus - 1%; avocado - 100%; balsam pear - 100%; banana - 100%;
barley - 100%; basil - 100%; bean, black - 1%; bean, broad - 1%; bean,
cowpea - 1%; bean, great northern - 1%; bean, kidney - 1%; bean, lima -
1%; bean, mung - 1%; bean, navy - 1%; bean, pink - 1%; bean, pinto -
1%; bean, snap - 25%; beet, garden - 15%; beet, sugar - 1%; blackberry
- 100%; blueberry - 15%; boysenberry - 100%; Brazil nut - 100%;
broccoli - 100%; Brussels sprouts - 100%; burdock - 100%; butternut -
100%; cabbage - 5%; canistel - 100%; cantaloupe - 10%; cardoon - 100%;
carrot - 10%; casaba - 100%; cashew - 100%; cassava - 100%; cattle fat,
kidney, liver, meat, and meat byproducts - 100%; cauliflower - 100%;
celeriac - 100%; celery - 10%; celtuce - 100%; chayote - 100%;
cherimoya - 100%; cherry - 5%; chestnut - 100%; chickpea - 1%; chicory
- 100%; Chinese waxgourd - 100%; chive - 100%; chrysanthemum, garland -
100%; cinnamon - 100%; citrus citron - 100%; citrus hybrids - 100%;
citrus, oil - 100%; collards - 100%; coriander - 100%; corn, field -
100%; corn, pop - 100%; corn, sweet - 10%; cottonseed, oil - 1%;
cranberry - 100%; cress, garden - 100%; cress, upland - 100%; cucumber
- 15%; currant - 100%; dandelion, leaves - 100%; dasheen, corm - 100%;
dasheen, leaves - 100%; dewberry - 100%; dill, seed - 100%; dillweed -
100%; eggplant - 100%; elderberry - 100%; endive - 100%; feijoa - 100%;
fennel, Florence - 100%; filbert - 5%; flaxseed, oil - 5%; garlic -
50%; ginger - 100%; ginseng - 100%; goat fat, kidney, liver, meat, and
meat byproducts - 100%; gooseberry - 100%; grape - 10%; grapefruit -
20%; guar, seed - 1%; guava - 100%; herbs, other - 100%; hickory nut -
100%; honeydew melon - 5%; hop - 100%; horse, meat - 100%; horseradish
- 100%; huckleberry - 100%; jaboticaba - 100%; jackfruit - 100%; kale -
100%; kohlrabi - 100%; kumquat - 100%; leek - 100%; lemon - 100%;
lemongrass - 100%; lentil, seed - 1%; lettuce, head - 1%; lettuce, leaf
- 1%; lime - 100%; loganberry - 100%; longan - 100%; loquat - 100%;
lychee - 100%; macadamia nut - 100%; mango - 100%; marjoram - 100%;
milk - 100%; mustard greens - 15%; nectarine - 100%; okra - 100%;
onion, dry bulb - 10%; onion, green - 10%; orange - 17%; papaya - 100%;
parsley - 30%; parsley, turnip-rooted - 100%; passionfruit - 100%;
pawpaw - 100%; pea, succulent - 1%; pea, dry - 1%; pea, edible podded -
25%; pea, pigeon - 1%; peach - 5%; peanut - 10%; pecan - 1%; pepper,
bell - 10%; pepper, non-bell - 10%; peppermint - 100%; persimmon -
100%; pistachio - 30%; plantain - 100%; plum - 1%; pork fat, kidney,
liver, meat, meat byproducts, and skin - 100%; potato - 25%; pummelo -
100%; pumpkin - 20%; radicchio - 100%; radish - 100%; radish, Oriental
- 100%; rape greens - 100%; rapeseed, oil - 5%; raspberry - 100%;
rhubarb - 100%; rice - 25%; rutabaga - 100%; safflower - 5%; salsify,
roots - 100%; salsify, tops - 100%; sapote, Mamey - 100%; savory -
100%; shallot - 100%; sheep fat, kidney, liver, meat, and meat
byproducts - 100%; sorghum - 100%; soursop - 100%; soybean - 1%;
Spanish lime - 100%; spearmint - 100%; spices, other - 100%; spinach -
10%; squash, summer - 15%; squash, winter - 15%; starfruit - 100%;
strawberry - 20%; sugar apple - 100%; sunflower - 5%; sweet potato -
100%; Swiss chard - 100%; tamarind - 100%; tangerine - 20%; tanier -
100%; tomatillo - 100%; tomato - 20%; turmeric - 100%; turnip, roots -
100%; turnip, greens - 15%; walnut - 1%; watercress - 100%; watermelon
- 25%; wheat - 1%; wild rice - 100%; yam, true - 100%; and yam bean -
100%.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6 years.
EPA uses an average PCT for chronic dietary risk analysis. The average
PCT figure for each existing use is derived by combining available
public and private market survey data for that use, averaging across
all observations, and rounding to the nearest 5%, except for those
situations in which the average PCT is less than one. In those cases,
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA
uses a maximum PCT for acute dietary risk analysis. The maximum PCT
figure is the highest observed maximum value reported within the recent
6 years of available public and private market survey data for the
existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which azoxystrobin may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for azoxystrobin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of azoxystrobin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) model for
surface water and the Screening Concentration in Ground Water (SCI-
GROW) model for ground water, the

estimated drinking water concentrations (EDWCs) of azoxystrobin for
acute exposures are estimated to be 173 parts per billion (ppb) for
surface water and 3.1 ppb for ground water and for chronic exposures
for non-cancer assessments are estimated to be 33 ppb for surface water
and 3.1 ppb for ground water. Modeled estimates of drinking water
concentrations were directly entered into the dietary exposure model.
For acute dietary risk assessment, the water concentration value of 173
ppb for surface water was used to assess the contribution to drinking
water. For chronic dietary risk assessment, the water concentration
value of 33 ppb for surface water was used to assess the contribution
to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Azoxystrobin is currently registered for the following uses that
could result in residential exposures: residential turf grass and
ornamentals, as well as indoor surfaces. EPA assessed residential
exposure using the following assumptions. Residential handlers may
receive short-term dermal and inhalation exposure to azoxystrobin when
mixing, loading and applying the formulations. Adults and children may
be exposed to azoxystrobin residues from dermal contact with foliage/
surfaces during postapplication activities. Toddlers may receive short-
and intermediate-term oral exposure from incidental ingestion during
postapplication activities.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found azoxystrobin to share a common mechanism of
toxicity with any other substances, and azoxystrobin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
azoxystrobin does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA (Food
Quality Protection Act) safety factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The available studies do not
indicate any evidence of increased susceptibility and there are no
residual uncertainties with regard to prenatal toxicity in rats or
rabbits following in utero and/or postnatal exposure to azoxystrobin.
In the prenatal developmental toxicity studies in rats and rabbits and
the 2-generation reproduction study in rats, any observed toxicity to
the offspring occurred at equivalent or higher doses than it did to
parental animals.
    3. Conclusion. The Agency has retained the FQPA SF at 3X, for the
following reasons:
    i. The toxicology data base is complete.
    ii. The developmental and reproductive toxicity data do not
indicate increased susceptibility of rats or rabbits to in utero and/or
postnatal exposure.
    iii. Although a NOAEL was not identified in the study used to
derive the aPAD, a 3X (as opposed to a 10X) is adequate to extrapolate
a NOAEL due to the low concern for the effect seen taking into account
the nature of the effect seen (transient diarrhea) and the overall
toxicity of this chemical;
    iv. The acute dietary food exposure assessment utilizes existing
and proposed tolerance level residues and 100 PCT information for all
commodities;
    v. The chronic dietary exposure analysis for azoxystrobin is a
somewhat refined assessment using less than 100% of the crop treated
data for selected existing crops (but a 100 PCT value for all new
crops);
    vi. The exposure assessments will not underestimate the potential
dietary (food and drinking water) or non-dietary exposures for infants
and children from the use of azoxystrobin;
    vii. The dietary drinking water assessment utilizes water
concentration values generated by model and associated modeling
parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations which are not
likely to be exceeded; and
    viii. The residential postapplication assessment is based upon the
residential standard operating procedures. The assessment is based upon
surrogate study data. These data are reliable and are not expected to
underestimate risk to adults or children. The residential SOPs are
based upon reasonable ``worst-case'' assumptions and are not expected
to underestimate risk.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water, and does not include dermal, inhalation, or incidental
oral exposure. Using these exposure assumptions, EPA has concluded that
acute exposure to azoxystrobin will occupy 70% of the aPAD for children
1-2 years old, the population group receiving the greatest exposure,
and 25% of the aPAD for the U.S. population as a whole.
    2. Chronic risk. The chronic aggregate risk assessment takes into
account average estimates of exposure to azoxystrobin from consumption
in food and drinking water. Using these exposure assumptions, EPA has
concluded that chronic exposure to azoxystrobin will utilize 15% of the
cPAD for children 1-2 years old, the population group receiving the
greatest exposure, and 6% of the cPAD for the U.S. population as a
whole.
    3. Short-term risk. Short-term aggregate exposure takes into
account

short-term (1-30 day) residential exposure plus chronic exposure to
food and drinking water (considered to be a background exposure level).
    Azoxystrobin is currently registered for uses that could result in
short-term residential exposure both for adults (because there is a
residential handler inhalation exposure scenario) and for toddlers and
children (because there is a residual post-application oral exposure
scenario). Dermal studies with azoxystrobin identified no toxic
endpoints so dermal exposure to azoxystrobin is not expected to pose a
short-term risk. The Agency has determined that it is appropriate to
aggregate chronic exposure through food and drinking water with short-
term residential exposures to azoxystrobin in performing this
assessment. High-end estimates of residential exposure are used in the
short-term assessment but average (i.e., chronic) exposure values are
used for food and drinking water exposure. Toddlers' incidental oral
exposure is assumed to include hand-to-mouth exposure, object-to-mouth
exposure, and exposure via incidental ingestion of soil.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has calculated the following aggregated short-term
food, water, and residential exposures and resulting MOEs. For the U.S.
population and all assessed subgroups the NOAEL used was 25 milligrams/
kilograms/day (mg/kg/day). For the U.S. population the estimated food
and drinking water exposure was 0.009878 mg/kg/day, the residential
exposure estimate was 0.00011 mg/kg/day, and the aggregate MOE was
2503. For the subgroup children (1-2 years) the estimated food and
drinking water exposure was 0.026629 mg/kg/day, the residential
exposure estimate was 0.089 mg/kg/day, and the aggregate MOE was 216.
For the subgroup youth (13-19 years) the estimated food and drinking
water exposure was 0.009499 mg/kg/day, the residential exposure
estimate was 0.00011 mg/kg/day, and the aggregate MOE was 2602. For the
subgroup females (13-49 years old) the estimated food and drinking
water exposure was 0.008081 mg/kg/day, the residential exposure
estimate was 0.00011 mg/kg/day, and the aggregate MOE was 3052. None of
these MOEs exceeds the Agency's level of concern for azoxystrobin. The
level of concern for azoxystrobin is for MOEs below 100.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term (1 to 6 months) residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
    Azoxystrobin is currently registered for uses that could result in
intermediate-term residential oral exposure for toddlers and children,
so an exposure assessment was conducted for that scenario. No endpoint
has been selected for intermediate-term dermal exposure to azoxystrobin
so no dermal assessment was performed. Intermediate-term residential
handler scenarios are not expected to occur, so this risk assessment
was not conducted for adults. The Agency has determined that it is
appropriate to aggregate chronic exposure to azoxystrobin through food
and drinking water with intermediate-term residential exposures to
azoxystrobin in doing this assessment. High-end estimates of
residential exposure are used in the intermediate-term assessment but
average (i.e., chronic) exposure values are used for food and drinking
water exposure.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures aggregated
result in an aggregate MOE for the population subgroup children 1-2
years old of 291, which does not exceed the Agency's level of concern.
This value and MOE are derived from a NOAEL for this subgroup of 20 mg/
kg/day, an LOC MOE of 100, an estimated average food and drinking water
exposure of 0.026629 mg/kg/day, and an estimated oral residential
exposure of 0.042 mg/kg/day.
    5. Aggregate cancer risk for U.S. population.The Agency has
determined that azoxystrobin is not likely to be a human carcinogen,
and thus azoxystrobin is not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to azoxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For analysis of plant commodities for residues of azoxystrobin and
the Z isomer of azoxystrobin a gas chromatography with nitrogen
phosphorus detector (GC/NPD) method (RAM 243/04) has been validated by
the Agency, revised, and sent to the Food and Drug Administration (FDA)
for inclusion in the Pesticide Analytical Manual (PAM), Volume II. This
method is adequate for enforcement of the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    No CODEX maximum residue levels (MRLs) have been established for
azoxystrobin. No Canadian or Mexican MRLs have been established for
azoxystrobin in or on the crops for which tolerances are being
established in this document.

C. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petition, EPA is not
modifying the existing tolerances for ruminant and swine raw
agricultural commodities (RACs) because a recalculation of the dietary
burdens of ruminants and swine indicates that no such changes are
necessary, while the proposed kidney and liver tolerances are covered
by existing meat byproducts tolerances. EPA is not establishing
tolerances for poultry RACs because a recalculation of dietary burdens
for poultry continues to indicate that there is no reasonable
expectation of finite residues in poultry commodities. EPA is raising
the proposed tolerance for sorghum grain from 9 ppm to 11 ppm based on
a review of the residue field trial data and EPA's statistical
examination of the residue data. The proposed tolerance of 112 ppm in
or on aspirated grain fractions is being raised to 420 ppm based on a
residue for sorghum grain of 8.46 ppm and a processing factor of 49.4x.
EPA is reducing the proposed tolerance of 30 ppm in or on wheat forage
to 25 ppm based on a review of the wheat forage field trial data and
EPA's statistical examination of the residue data; these data have also
been translated to barley, forage with the result that this proposed
tolerance is also being reduced from 30 to 25 ppm. A review of the
residue data from use on cotton leads EPA to reduce the proposed
tolerance for undelinted cotton seed from 0.7 to 0.6 ppm and to
increase the proposed tolerance for cotton gin byproducts from 35 to 45
ppm. EPA is also raising the proposed tolerance for non-grass animal
feeds, forage from 35 to 45 ppm and the proposed tolerance for non-
grass animal feeds, hay from 100 to 120 ppm based on a review of the
field trial data for use on alfalfa and clover forage and hay and EPA's
statistical examination of the residue data. EPA is also revoking the

time-limited tolerance for Brassica, head and stem, subgroup 5A of 30
ppm, and for safflower, seed at 1.0 ppm, both in 40 CFR 180.507(b),
because they expired on December 31, 2006, and June 30, 2008,
respectively. Furthermore, Brassica, head and stem, subgroup 5A and
safflower, seed have existing tolerances under 40 CFR 180.507(a)(1).
The rice, wild time-limited tolerance in 40 CFR 180.507(b) is also
being revoked because it is being superceded by a permanent tolerance
for rice, wild, grain.

V. Conclusion

    Therefore, tolerances are established for combined residues of
azoxystrobin (methyl (E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate) and the Z isomer of azoxystrobin
(methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-
methoxyacrylate) in or on animal feed, nongrass, forage, group 18 at 45
ppm; animal feed, nongrass, hay, group 18 at 120 ppm; barley, forage at
25 ppm; cotton, gin byproducts at 45 ppm; cotton, undelinted seed at
0.6 ppm; grain, aspirated fractions at 420 ppm; rice, wild, grain at
5.0 ppm; sorghum, forage at 25 ppm; sorghum, grain at 11 ppm; sorghum,
stover at 40 ppm; and wheat, forage at 25 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: June 30, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.507 is amended by:
0
i. Removing the first entry for ``grain, aspirated fractions'' at 10
ppm in paragraph (a)(1).
0
ii. Revising the entries ``cotton, gin byproducts''; ``cotton,
undelinted seed''; and ``grain, aspirated fractions.''
0
iii. Alphabetically adding entries to the table in paragraph (a)(1).
0
iv. Removing the text of paragraph (b) and reserving the paragraph
designation and heading.

Sec.  180.507  Azoxystrobin; tolerances for residues.

    (a) General. (1) * * *

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
Animal feed, nongrass, forage, group 18...............                                                        45
Animal feed, nongrass, hay, group 18..................                                                       120
                                                    * * * * *
Barley, forage........................................                                                        25
                                                    * * * * *
Cotton, gin byproducts................................                                                        45
Cotton, undelinted seed...............................                                                       0.6
                                                    * * * * *
Grain, aspirated fractions............................                                                       420

                                                    * * * * *
Rice, wild, grain.....................................                                                       5.0
                                                    * * * * *
Sorghum, forage.......................................                                                        25
Sorghum, grain........................................                                                        11
Sorghum, stover.......................................                                                        40
                                                    * * * * *
Wheat, forage.........................................                                                        25
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
    (b) Section 18 emergency exemption. [Reserved]
* * * * *
[FR Doc. E8-15517 Filed 7-8-08; 8:45 am]

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[Federal Register: April 1, 2010 (Volume 75, Number 62)]
[Rules and Regulations]
[Page 16335-16336]
[DOCID:fr01ap10-8]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0069; Airspace Docket No. 10-ASO-15]

Establishment of Class E Airspace; Mount Pleasant, SC

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Direct final rule; request for comments.

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

SUMMARY: This action establishes Class E airspace at Mount Pleasant,
SC, to accommodate Standard Instrument Approach Procedures (SIAPs) at
Mt Pleasant Regional Airport-Faison Field. This action enhances the
safety and airspace management of Instrument Flight rules (IFR)
operations at the airport.

DATES: Effective 0901 UTC, June 3, 2010. Comments for inclusion in the
Rules Docket must be received on or before May 17, 2010. The Director
of the Federal Register approves this incorporation by reference action
under Title 1, Code of Federal Regulations, part 51, subject to the
annual revision of FAA Order 7400.9 and publication of conforming
amendments.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001;
Telephone: 1-800-647-5527; Fax:<PHONE_NUMBER>. You must identify the
Docket Number FAA-2010-0069; Airspace Docket No. 10-ASO-15, at the
beginning of your comments. You may also submit and review received
comments through the Internet at http://www.regulations.gov.
    You may review the public docket containing the rule, any comments
received, and any final disposition in person in the Dockets Office
(see ADDRESSES section for address and phone number) between 9 a.m. and
5 p.m., Monday through Friday, except Federal Holidays. An informal
docket may also be examined during normal business hours at the office
of the Eastern Service Center, Federal Aviation Administration, Room
210, 1701 Columbia Avenue, College Park, Georgia 30337.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

The Direct Final Rule Procedure

    The FAA anticipates that this regulation will not result in adverse
or negative comments, and, therefore, issues it as a direct final rule.
The FAA has determined that this rule only involves an established body
of technical regulations for which frequent and routine amendments are
necessary to keep them operationally current. Unless a written adverse
or negative comment or a written notice of intent to submit an adverse
or negative comment is received within the comment period, the
regulation will become effective on the date specified above. After the
close of the comment period, the FAA will publish a document in the
Federal Register indicating that no adverse or negative comments were
received and confirming the effective date. If the FAA receives, within
the comment period, an adverse or negative comment, or written notice
of intent to submit such a comment, a document withdrawing the direct
final rule will be published in the Federal Register, and a notice of
proposed rulemaking may be published with a new comment period.

Comments Invited

    Although this action is in the form of a direct final rule, and was
not preceded by a notice of proposed rulemaking, interested persons are
invited to comment on this rule by submitting such written data, views,
or arguments as they may desire. An electronic copy of this document
may be downloaded from and comments may be submitted and reviewed at
http://www.regulations.gov. Recently published rulemaking documents can
also be accessed through the FAA's Web page at http://www.faa.gov/
airports_airtraffic/air_traffic/publications/airspace_amendments.
Communications should identify both docket numbers and be submitted in
triplicate to the address specified under the caption ADDRESSES above
or through the Web site. All communications received on or before the
closing date for comments will be considered, and this rule may be
amended or withdrawn in light of the comments received.
    Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the rule that might
suggest a need to modify the rule. Factual information that supports
the commenter's idea and suggestions is extremely helpful in evaluating
the effectiveness of this action and determining whether additional
rulemaking action would be needed. All comments submitted will be
available, both before and after the closing date for comments, in the
Rules Docket for examination by interested persons. Those wishing the
FAA to acknowledge receipt of their comments submitted in response to
this rule must submit a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2010-0069;
Airspace Docket No. 10-ASO-15.'' The postcard will be date stamped and
returned to the commenter.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 establishes Class E airspace at Mount Pleasant, SC, to provide
controlled airspace extending upward from 700 feet above the surface of
the earth to support the SIAPs that have been developed for Mt Pleasant
Regional Airport-Faison Field.
    Designations for Class E airspace areas extending upward from 700
feet or more above the surface of the Earth are published in FAA Order
7400.9T, signed August 27, 2009, and effective September 15, 2009,
which is incorporated by reference in 14 CFR 71.1. The Class E
designations listed in this document will be published subsequently in
the Order.

Agency Findings

    The regulations adopted herein will not have substantial direct
effects on the

States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among
various levels of government. Therefore, it is determined that this
direct final rule does not have federalism implications under Executive
Order 13132.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that 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 United States Code. 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.
    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 establishes Class E airspace at Mount Pleasant, SC.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of Amendment

0
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 CLASS E AIRSPACE
AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 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 71.1 of Federal Aviation
Administration Order 7400.9T, Airspace Designations and Reporting
Points, signed August 27, 2009, effective September 15, 2009, is
amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO SC E5 Mount Pleasant, SC [New]

Mt Pleasant Regional Airport-Faison Field, SC
    (Lat. 32[deg]53[min]52[sec] N., long. 79[deg]46[min]58[sec] W.)

    That airspace extending upward from 700 feet above the surface
within a 6.3-mile radius of the Mt Pleasant Regional Airport-Faison
Field.

    Issued in College Park, Georgia, on March 18, 2010.
Michael Vermuth,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2010-6831 Filed 3-31-10; 8:45 am]
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