[Federal Register: March 22, 2010 (Volume 75, Number 54)]
[Proposed Rules]
[Page 13451-13453]
[DOCID:fr22mr10-7]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-27009; Directorate Identifier 2007-NE-02-AD]
RIN 2120-AA64

Airworthiness Directives; Turbomeca Arriel 2B1 Turboshaft Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to revise an existing airworthiness directive
(AD) for Turbomeca Arriel 2B1 turboshaft engines. This proposed AD
results from mandatory continuing airworthiness information (MCAI)
issued by an aviation authority of another country to identify and
correct an unsafe condition on an aviation product. The MCAI describes
the unsafe condition as: Since the issuance of AD 2007-0126
Turbom[eacute]ca has released modification TU157 which consists in
modifying the pressure relief valve of the HMU by introducing a damping
device into the valve. Introduction of this device has demonstrated to
decrease the pressure fluctuations in the system, therefore reducing
significantly the risk of wear of the delta-P diaphragm fabric. This
will delete the need for a periodical replacement of the delta-P
diaphragm before overhaul of the HMU. The modification TU157 is
therefore considered as the terminating action for this AD.
    We are proposing this AD to prevent the loss of automatic control
mode coupled with the deteriorated performance of the backup mode,
which can lead to the inability to continue safe flight, forced
autorotation landing, or an accident.

DATES: We must receive any comments on this proposed AD by April 21,
2010.

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

FOR FURTHER INFORMATION CONTACT: Kevin Dickert, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2007-
27009; Directorate Identifier 2007-NE-02-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is the same as
the Mail address provided in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

Discussion

    On September 11, 2007, the FAA issued AD 2007-19-09, Amendment 39-
15200 (72 FR 53112, September 18, 2007). That AD requires initial and
repetitive replacement of the hydromechanical metering unit (HMU) with
a serviceable HMU every 1,500 operating hours. The European Aviation
Safety Agency (EASA), which is the Technical Agent for the Member
States of the European Community, has issued EASA Airworthiness
Directive 2007-0126, dated May 7, 2007, (referred to after this as
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    This AD is prompted by several reported cases of rupture of the
constant delta pressure valve diaphragm on Arriel 2B1 engines, due
to the wear of the delta-P diaphragm fabric. Rupture can result in
the loss of the automatic control mode of the helicopter,
accompanied with a deterioration of the behavior of the auxiliary
back-up mode (emergency mode). On a single-engine helicopter, the
result may be an emergency landing or, at worst, an accident.
    This AD supersedes AD EASA AD 2007-0006 which required the
removal from service of all the delta pressure valve diaphragms
logging more than 2,000 hours-since-new.
    Since issuance of EASA AD 2007-0006, no further case of rupture
of the constant delta pressure valve diaphragm has been reported on
Arriel 2 engines. However, about 40 additional diaphragms returning
from service have been inspected by Turbomeca, and some signs of
wear have been detected on diaphragms having logged less than 2,000
hours. Based on the inspection results, it has been decided to
decrease this limit from 2,000 hours to 1,500 hours in order to
further reduce the probability of delta-P diaphragm rupture.

Actions Since AD 2007-19-09 Was Issued

    Since that AD was issued, the EASA has issued MCAI AD 2009-0091,
dated May 4, 2009. The MCAI states:

    Since the issuance of AD 2007-0126 Turbom[eacute]ca has released
modification TU157 which consists in modifying the pressure relief
valve of the HMU by introducing a damping device into the valve.
    Introduction of this device has demonstrated to decrease the
pressure fluctuations in the system, therefore reducing
significantly the risk of wear of the delta-P diaphragm fabric. This
will delete the need for a periodical replacement of the delta-P
diaphragm before overhaul of the HMU. The modification TU157 is
therefore considered as the terminating action for this AD.
    This AD supersedes AD 2007-0126 by retaining the same
requirements as in AD 2007-0126 except that:

     In addition to the ARRIEL 2B1 engines, applicability is
extended to the ARRIEL 2B1A engines, which share the same HMU
design.
     Applicability is limited to ARRIEL 2B1 and 2B1A engines
that do not incorporate modification TU157.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Turbomeca S.A. has issued Mandatory Service Bulletin No. 292 73
2818, Original Issue, dated October 18, 2006 and Update 1, dated April
3, 2007. The actions described in this service information are intended
to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of France,
and is approved for operation in the United States. Pursuant to our
bilateral agreement with France, they have notified us of the unsafe
condition described in the MCAI referenced above. We are proposing this
AD because we evaluated all information provided by EASA and determined
the unsafe condition exists and is likely to exist or develop on other
products of the same type design. This proposed AD would require
initial and repetitive replacement of the HMU with a serviceable HMU
every 1,500 hours-since-new, hours-since-last-overhaul (HSO), or since
incorporation of Turbomeca Service Bulletin (SB) No. 292 73 2105,
whichever occurs later.

Differences Between This AD and the MCAI or Service Information

    The MCAI applies to the ARRIEL 2B1 and 2B1A engines. The ARRIEL
2B1A engine is not type certificated in the United States, so this
proposed AD applies to the ARRIEL 2B1 engine model only.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 103 products of U.S. registry. We also estimate that
it would take about 0.75 work-hour per product to comply with this
proposed AD. The average labor rate is $85 per work-hour. Required
parts would cost about $10,550 per product. Based on these figures, we
estimate the cost of the proposed AD on U.S. operators to be
$1,093,216.

Authority for This Rulemaking

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

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the proposed AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD. See the ADDRESSES section for a location
to examine the regulatory evaluation.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the Federal Aviation Administration proposes to amend 14
CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by removing Amendment 39-15200 (72 FR
53112, September 18, 2007) and by adding a new airworthiness directive,
to read as follows:

Turbomeca: Docket No. FAA-2007-27009; Directorate Identifier 2007-
NE-02-AD.

Comments Due Date

    (a) The Federal Aviation Administration (FAA) must receive
comments on this airworthiness directive (AD) action by April 21,
2010.

Affected ADs

    (b) This AD revises AD 2007-19-09.

Applicability

    (c) This AD applies to Turbomeca ARRIEL 2B1 turboshaft engines
that don't incorporate modification TU157. These engines are
installed on, but not limited to, Eurocopter AS 350 B3 and EC 130 B4
helicopters.

Reason

    (d) European Aviation Safety Agency (EASA) AD No. 2009-0091,
dated May 4, 2009, states:

    Since the issuance of AD 2007-0126 Turbom[eacute]ca has released
modification TU157 which consists in modifying the pressure relief
valve of the HMU by introducing a damping device into the valve.
Introduction of this device has demonstrated to decrease the
pressure fluctuations in the system, therefore reducing
significantly the risk of wear of the delta-P diaphragm fabric. This
will delete the need for a periodical replacement of the delta-P
diaphragm before overhaul of the HMU. The modification TU157 is
therefore considered as the terminating action for this AD.

We are issuing this AD to prevent the loss of automatic control mode
coupled with the deteriorated performance of the backup mode, which
can lead to the inability to continue safe flight, forced
autorotation landing, or an accident.

Actions and Compliance

    (e) Unless already done, do the following actions.
    (1) For ARRIEL 2B1 engines that incorporate modification TU157,
no further action is required.
    (2) For all other ARRIEL 2B1 engines do the following:
    (i) Replace the hydromechanical metering unit (HMU) with a
serviceable HMU before the HMU accumulates 1,500 hours-since-new,
hours-since-last-overhaul (HSO), or since incorporation of Turbomeca
Service Bulletin (SB) No. 292 73 2105, whichever occurs later.
    (ii) Thereafter, replace the HMU with a serviceable HMU at every
1,500 hours-since new, since last overhaul, or since incorporation
of Turbomeca SB No. 292 73 2105, whichever occurs later.
    (iii) For the purposes of this AD, a serviceable HMU is an HMU
fitted with a new constant delta P diaphragm in accordance with
Turbomeca Mandatory Service Bulletin (MSB) No. 292 73 2818,

Original Issue, Dated October 18, 2006, or Update No. 1, dated April
3, 2007.

Optional Terminating Action

    (3) Replacing the HMU with an HMU that has been modified to
TU157 terminates the repetitive requirement of paragraph (e)(2)(ii)
of this AD.

FAA AD Differences

    (f) This AD differs from the Mandatory Continuing Airworthiness
Information (MCAI) because the MCAI applies to the ARRIEL 2B1 and
2B1A engines. The ARRIEL 2B1A engine is not type certificated in the
United States, so this proposed AD applies to the ARRIEL 2B1 engine
model only.

Other FAA AD Provisions

    (g) Alternative Methods of Compliance (AMOCs): The Manager,
Engine Certification Office, FAA, has the authority to approve AMOCs
for this AD, if requested using the procedures found in 14 CFR
39.19.

Related Information

    (h) Contact Kevin Dickert, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>,
for more information about this AD.

    Issued in Burlington, Massachusetts on March 15, 2010.
Francis A. Favara,
Manager, Engine and Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2010-6179 Filed 3-19-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)]
[Notices]
[Pages 2931-2933]
[FR Doc No: 2016-00784]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76881; File No. SR-CBOE-2015-119]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend the Fees Schedule

January 12, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on December 30, 2015, Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I, II, and III 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 Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Fees Schedule relating to
Continuing Education Fees. The text of the proposed rule change is
available on the Exchange's Web site (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange'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
    The Exchange proposes to amend the Fees Schedule. Specifically, the
Exchange proposes to make changes to the Continuing Education Fees
section of the Fees Schedule to delete references to the Series 56
registration and to provide that continuing education (``CE'') fees for
all registration categories will be $100 if conducted at a test center
or $55 if conducted via Web-based delivery. This filing is being
submitted pursuant to recent changes to Interpretation and Policy .08
to Rule 3.6A (Qualification and Registration of Trading Permit Holders
and Associated Persons) and to Rule 9.3A (Continuing Education for
Registered Persons), which provide that effective January 4, 2016, the
S501 Series 56 Proprietary Trader CE Program for Series 56 registered
persons will cease to exist and that Series 57 registered persons are
instead permitted [sic] to enroll in the S101 General Program for
Series 7 and all other registered persons, which will be made available
via Web-delivery as of that date.\3\
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    \3\ See Securities Exchange Act Release No. 76247 (October 23,
2015), 80 FR 66605 (October 29, 2015) (Notice of Filing and
Immediate Effectiveness of a Proposed Rule Change Relating to
Qualification and Registration of Trading Permit Holders and
Associated Persons) (SR-CBOE-2015-094); Securities Exchange Act
Release No. 76107 (October 8, 2015), 80 FR 62139 (October 15, 2015)
(Notice of Filing and Immediate Effectiveness of a Proposed Rule
Change Relating to Delivery of the Regulatory Element of the
Exchange's Continuing Education Program) (SR-CBOE-2015-084).

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    Pursuant to Rule 9.3A (Continuing Education for Registered
Persons), no Trading Permit Holder (``TPH'') or TPH organization shall
permit any registered person to continue to, and no registered person
shall continue to perform duties as a registered person unless such
person has complied with the Exchange's CE requirements as prescribed
under the Rules.\4\ The CE requirements under Rule 9.3A consist of a
Regulatory Element \5\ and a Firm Element.\6\ The Regulatory Element
applies to all registered persons \7\ and consists of periodic
computer-based training on regulatory, compliance, ethical, and
supervisory subjects and sales practice standards, which must be
completed within prescribed timeframes.\8\ Currently, the Exchange
offers the following Regulatory Elements for Exchange registered
persons: the S201 Supervisor Program for registered principals and
supervisors; the S106 Series 6 Program for Series 6 registered persons;
the S501 Series 56 Proprietary Trader CE Program for Series 56
registered persons, and the S101 General Program for Series 7 and all
other registered persons.\9\
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    \4\ See Rule 9.3A(a) (Regulatory Element).
    \5\ See id.
    \6\ See Rule 9.3A(c) (Firm Element).
    \7\ For purposes of the Regulatory Element, a ``registered
person'' means a TPH, associated person, and/or Representative
approved by and registered with the Exchange. See Interpretation and
Policy .01 to Rule 9.3A.
    \8\ Pursuant to Rule 9.3A(a), each registered person shall
complete the Regulatory Element of the CE Program beginning with the
occurrence of their second registration anniversary date and every
three years thereafter, or as otherwise prescribed by the Exchange.
On each occasion, the Regulatory Element must be completed within
120 days after the person's registration anniversary date. A
person's initial registration date, also known as the ``base date,''
shall establish the cycle of anniversary dates for purposes of the
Rule. The content of the Regulatory Element of the Program is
determined by the Exchange for each registration category of persons
subject to the Rule. In addition, a registered person is required to
retake the Regulatory Element in the event that such person: (i)
becomes subject to any statutory disqualification as defined in
Section 3(a)(39) of the Securities Exchange Act of 1934 (the
``Act''); (ii) becomes subject to suspension or to the imposition of
a fine of $5,000 or more for violation of any provision of any
securities law or regulation, or any agreement with or rule or
standard of conduct of any securities governmental agency,
securities self-regulatory organization, or as imposed by any such
regulatory or self-regulatory organization in connection with a
disciplinary proceeding; or (iii) is ordered as a sanction in a
disciplinary action to re-take the Regulatory Element by any
securities governmental agency or securities self-regulatory
organization. See Rule 9.3A(a)(2) (Disciplinary Actions).
    \9\ See Rule 9.3A(a)(3) (Required Programs).
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    The Financial Regulatory Authority (``FINRA'') administers the
Exchange's CE Programs on behalf of the Exchange. On August 6, 2015,
the Securities and Exchange Commission (``Commission'' or ``SEC'')
approved amendments to FINRA Rule 1250 (Continuing Education
Requirements) to provide a Web-based delivery method for completing the
Regulatory Element of the CE requirements and to establish a fee for
Web-based delivery of the Regulatory Element of the CE
requirements.\10\ Consistent with the changes to FINRA Rule 1250, the
Exchange submitted a rule filing to make similar changes to its CE
Program requirements on September 30, 2015.\11\ Accordingly, effective
October 1, 2015, the Regulatory Elements of Exchange's CE Programs for
the S106 for Investment Company and Variable Contracts Representatives,
the S201 for Registered Principals and Supervisors, and the S901 for
Operations Professionals were made available via Web-based delivery
pursuant to Rule 9.3A.
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    \10\ See Securities Exchange Act Release No. 75581 (July 31,
2015), 80 FR 47018 (August 6, 2015) (Order Approving a Proposed Rule
Change to Provide a Web-based Delivery Method for Completing the
Regulatory Element of the Continuing Education Requirements) (SR-
FINRA-2015-015).
    \11\ See Securities Exchange Act Release No. 76107 (October 8,
2015), 80 FR 62139 (October 15, 2015) (Notice of Filing and
Immediate Effectiveness of a Proposed Rule Change Relating to
Delivery of the Regulatory Element of the Exchange's Continuing
Education Program) (SR-CBOE-2015-084).
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    In addition to the changes to Rule 9.3A with respect to Web-based
delivery of the Regulatory Element of the CE Programs for the S106 for
Investment Company and Variable Contracts Representatives, S201 for
Registered Principals and Supervisors, and S901 for Operations
Professionals, the Exchange also amended Rule 9.3A to remove the option
for Series 56 registered persons to participate in the S501 Series 56
Proprietary Trader CE program in order to satisfy the Regulatory
Element of the Exchange's CE Program. Pursuant to recent changes to
Interpretation and Policy .08 to Rule 3.6A, the S501 Series 56
Proprietary Trader CE program is being phased out along with the Series
56 Proprietary Trader qualification examination and being replaced with
the Series 57 Securities Trader qualification examination.\12\ As a
result, effective January 4, 2016, the S501 Series 56 Proprietary
Trader CE Program for Series 56 registered persons will cease to exist.
In place of the S501 Series 56 Proprietary Trader CE Program for Series
56 registered persons, Series 57 registered persons will be permitted
[sic] to enroll in the S101 General Program for Series 7 and all other
registered persons, including, but not limited to Series 57 registered
persons beginning January 4, 2016.
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    \12\ See Securities Exchange Act Release No. 76247 (October 23,
2015), 80 FR 66605 (October 29, 2015) (Notice of Filing and
Immediate Effectiveness of a Proposed Rule Change Relating to
Qualification and Registration of Trading Permit Holders and
Associated Persons) (SR-CBOE-2015-094); see also Securities Exchange
Act Release No. 75783 (August 28, 2015) (Order Approving a Proposed
Rule Change to Establish the Securities Trader and Securities Trader
Principal Registration Categories) (SR-FINRA-2015-017).
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    Consistent with SR-FINRA-2015-015, the purpose of this filing is to
amend the Fees Schedule to reflect the $55 fee [sic] for Web-based
delivery of the Regulatory Element of the S101 General Program for
Series 7 and all other registered persons, including, but not limited
to Series 57 registered Securities Traders.\13\ Pursuant to SR-FINRA-
2015-015, delivery of the Regulatory Element of the S101, S106, S201,
and S901 CE Programs will continue to be offered at testing centers for
a period up to no later than six months after January 4, 2016 and the
fees for test center delivery of the Regulatory Element of the S101,
S106, S201, and S901 CE Programs will continue to be $100 for so long
as such programs are available at testing centers.\14\ Consistent with
SR-FINRA-2015-015, under the Exchange's proposed rule change, test
center delivery of the Regulatory Element of the S101 CE Program would
continue to be $100 for so long as such programs are available at
testing centers. In addition, also consistent with SR-FINRA-2015-015,
under the Exchange's proposed rule change, Web-based delivery of the
Regulatory Element of the S101 CE Program would be $55, beginning
January 4, 2016.\15\
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    \13\ See Securities Exchange Act Release No. 75581 (July 31,
2015), 80 FR 47018 (August 6, 2015) (Order Approving a Proposed Rule
Change to Provide a Web-based Delivery Method for Completing the
Regulatory Element of the Continuing Education Requirements) (SR-
FINRA-2015-015).
    \14\ Test-center delivery of the Regulatory Element will be
phased out by no later than six months after January 4, 2016. See
Securities Exchange Act Release No. 75581 (July 31, 2015), 80 FR
47018 (August 6, 2015) (Order Approving a Proposed Rule Change To
Provide a Web-Based Delivery Method for Completing the Regulatory
Element of the Continuing Education) (SR-FINRA-2015-015). At that
time, the Exchange will file another fee filing to remove the test
center option for delivery of the Regulatory Element from the Fees
Schedule. See Securities Exchange Act Release No. 76352 (November 4,
2015), 80 FR 69760 (November 10, 2015) (Notice of Filing and
Immediate Effectiveness of a Proposed Rule Change to Amend the Fees
Schedule) (SR-CBOE-2015-093). The Exchange has already amended the
Fees schedule to reflect the $55 fee for Web-based delivery of the
Regulatory Elements of the S106, S201, and S901 CE Programs. See id.
    \15\ See id.

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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder applicable to the
Exchange and, in particular, the requirements of Section 6(b) of the
Act.\16\ Specifically, the Exchange believes the proposed rule change
is consistent with the Section 6(b)(5) \17\ requirements that the rules
of an exchange be 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.
Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \18\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \16\ 15 U.S.C. 78f(b).
    \17\ 15 U.S.C. 78f(b)(5).
    \18\ Id.
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    In particular, the Exchange believes that Web-based administration
of the Regulatory Element of the Exchange's CE Program and the lower
costs associated with Web-based administration of the Regulatory
Element of the Exchange's CE Program are ends that may serve to
increase access to the markets, which is in the interests of investors
and consistent with the Act. In general, Web-based delivery of the
Regulatory Element of the Exchange's CE Programs at a reduced cost
lowers barriers to entry [sic] and removes impediments to a free and
open market and national market system by making it easier and less
costly for TPHs to participate in the markets. Accordingly, the
Exchange believes that offering Web-based delivery of the Regulatory
Element of Exchange's CE Program at a reduced cost and that lowering
the cost of CE in general are goals that are consistent with the Act.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. As FINRA has stated, the
proposed rule change is specifically intended to reduce the burdens of
continuing education on market participants while preserving the
integrity its CE Programs. In general, reduction in cost and removal of
barriers to entry encourages competition among market participants,
particularly in situations where such rules are consistently employed
across the markets. By bringing the Exchange's fees structure in line
with that of FINRA, the Exchange believes it is removing impediments to
free and open markets and encouraging competition between the Exchange
and other markets that utilize FINRA's CE Programs. For the foregoing
reasons, the Exchange believes that the proposed rule change will
relieve burdens on, and otherwise promote, competition.

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

    The Exchange neither solicited nor received written comments on the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \19\ and paragraph (f) of Rule 19b-4 \20\
thereunder. 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 will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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-CBOE-2015-119 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-CBOE-2015-119. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the 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-CBOE-2015-119 and should be
submitted on or before February 9, 2016.
---------------------------------------------------------------------------

    \21\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-00784 Filed 1-15-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 218 (Thursday, November 12, 2015)]
[Notices]
[Pages 70054-70057]
[FR Doc No: 2015-28692]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76375; File No. SR-BX-2015-64]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Related to
Price Improving and Post-Only Orders

November 5, 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 October 30, 2015, NASDAQ OMX BX, Inc. (``BX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``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.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to remove a ``Price Improving Order'' and a
``Post-Only Order'' as eligible order types for entry into the
automated system for order execution and trade reporting owned and
operated by BX (``System'').
    The Exchange requests that the Commission waive the 30-day
operative delay period contained in Exchange Act Rule 19b-
4(f)(6)(iii).\3\
---------------------------------------------------------------------------

    \3\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxbx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange is seeking to remove references to ``Price Improving
Orders'' in the Rulebook. Specifically, the Exchange is seeking to
amend the following sections of the Rulebook: Chapter III, Section 4,
entitled ``Prevention of the Misuse of Material Nonpublic
Information;'' Chapter VI, Section 1, entitled ``Definitions,'' Section
6, entitled ``Acceptance of Quotes and Orders'' and Section 7, entitled
``Entry and Display of Orders;'' and Chapter VII, Section 12, entitled
``Order Exposure Requirements.''
    The Exchange is also seeking to remove references to ``Post-Only
Orders'' in the Rulebook. Specifically, the Exchange is seeking to
amend the following sections in the Rulebook: Chapter VI, Section 1,
entitled ``Definitions,'' Section 6, entitled ``Acceptance of Quotes
and Orders'' and Section 9 entitled ``Price Improvement Auction
(``PRISM'').''
    Each order type will be explained in more detail below.
Price Improving Orders
    Price Improving Orders are orders to buy or sell an option at a
specified price at an increment smaller than the minimum price
variation in the security. Today, Price Improving Orders may be entered
in increments as small as one cent and are available for display at the
minimum price variation (``MPV'') in that security and shall be rounded
up for sell orders and rounded down for buy orders. Without this order
type, market participants would not be able to submit orders or quotes
priced between the MPV; those orders or quotes would be rejected.
    The Exchange proposes to amend Chapter III, Section 4, entitled
``Prevention of the Misuse of Material Nonpublic Information'' to
remove Price Improving Orders as an example of an order type that would
be violative of this rule. The Exchange proposes to remove the
definition of a Price Improving Order from the list of order types that
are acceptable on BX in Chapter VI, Section I, entitled
``Definitions.'' The Exchange proposes to amend Chapter VI, Section 6,
entitled ``Acceptance of Quotes and Orders'' to remove Price Improving
Orders as an acceptable order type. The Exchange proposes to amend
Chapter VI, Section 7, entitled ``Entry and Display of Orders'' to
remove language describing the manner in which Price Improving Orders
are displayed in the System. Finally, the Exchange proposes to amend
Chapter VII, Section 12, entitled ``Order Exposure Requirements'' to
remove the reference to the exposure time for Price Improving Orders.
    Today, Price Improving Orders on BX represent less than 1.5% of the
BX volume. The Exchange is removing this order type in connection with
its recent filing of a price improving auction (PRISM).\4\ This
proposed auction mechanism will offer participants an alternative means
of entering price improving interest.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 76301 (October 29,
2015) (SR-BX-2015-032) (Order Granting Accelerated Approval of a
Proposed Rule Change, as Modified by Amendment Nos. 1 and 2, to
Adopt a New Price Improvement Auction, BX PRISM) (not yet published)
[sic].
---------------------------------------------------------------------------

    The Exchange believes that PRISM should promote and foster
competition and provide more options contracts with the opportunity for
price improvement. As a result of the increased opportunities for price
improvement, the Exchange believes that participants will use PRISM to
increase the number of Public Customer orders that are provided with
the opportunity to receive price improvement over the NBBO.
Post-Only Orders
    Post-Only Orders are orders that will not remove liquidity from the
System. Post-Only Orders are to be ranked and executed on the Exchange
or cancelled, as appropriate, without routing away to another market.
Post-Only Orders are evaluated at the time of entry with respect to
locking or crossing other orders as follows: (i) If a Post-Only Order
would lock or cross an order on the System, the order will be re-priced
to $.01 below the current low offer (for bids) or above the current
best bid (for offers) and displayed by the System at one minimum price
increment below the current low offer (for bids) or above the current
best bid (for offers); and (ii) if a Post-Only Order would not lock or
cross an order on the System but would lock or cross the NBBO as
reflected in the protected quotation of another market center, the
order will be handled pursuant to Chapter VI, Section 7(b)(3)(C).
Participants may choose to have their Post-Only Orders returned
whenever the order would lock or cross the NBBO or be placed on the
book at a price other than its limit price. Post-Only Orders received
prior to the opening cross or after market close will be rejected.
Post-Only Orders may not have a time-in-force designation of Good Til
Cancelled or Immediate or Cancel.
    The Exchange proposes to remove the definition of a Post-Only Order
from the list of order types that are acceptable on BX in Chapter VI,
Section I, entitled ``Definitions.'' The Exchange proposes to amend
Chapter VI, Section 6, entitled ``Acceptance of Quotes and Orders'' to
remove Post-Only Orders as an acceptable order type. Finally, the
Exchange proposes to amend Chapter VI, Section 9, entitled ``Price
Improvement Auction (``PRISM'')'' to remove an explanation on the
manner in which Post-Only Orders will interact in the auction process.
    Today, the Exchange transacts a small number of Post-Only Orders on
BX.\5\ The Exchange adopted the Post-Only Order to encourage displayed
liquidity and offer BX market participants greater flexibility to post
liquidity on BX. Participants are not utilizing this order type very
frequently. As previously mentioned, the Exchange is removing the
Price-Improving Order in connection with its recent filing of a price
improving auction (PRISM).\6\ This proposed auction mechanism will
offer participants a new means of entering price improving interest.
Aside from Price-Improving Orders, the Post-Only Order is the only
other non-displayed order type currently on BX. At this time, the
Exchange proposes to also remove the Post-Only Order from BX which
would result in all remaining order types on BX being displayed similar
to NASDAQ OMX PHLX LLC (``Phlx'') order types.
---------------------------------------------------------------------------

    \5\ The Exchange transacted on 90 Post-Only Orders from July
through September 2015.
    \6\ See note 4.
---------------------------------------------------------------------------

    This proposed rule change would remove Price Improving Orders and
Post-Only Orders as acceptable order types for orders or quotes entered
into BX's System for all market participants.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \7\ in general, and furthers the objectives of Section
6(b)(5) of the Act \8\ in particular, in that it is designed to promote
just and equitable principles of trade, 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,
by removing Price Improving and Post-Only Orders as acceptable order
types for all market participants.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

Price-Improving Orders
    With the removal of Price Improving Orders, market participants
would not

be able to submit orders or quotes priced between the MPV; those orders
would be rejected. Other options exchanges currently do not offer a
similar order type.\9\ The Exchange believes that the removal of the
Price Improving Order does not otherwise create an impediment to a free
and open market. The Exchange believes this proposed amendment is non-
controversial. By not accepting Price Improving Orders, BX's true BBO
will be transparent. All orders will be disseminated at the prices and
sizes submitted by market participants at the time of entry into the
System.\10\ The Exchange believes that market participants will
continue to quote at their best prices and the market will be more
transparent. The Exchange believe that despite the removal of the
availability and use of Price Improving Orders, the Exchange will
remain competitive.
---------------------------------------------------------------------------

    \9\ See Phlx and BOX Options Exchange LLC, which do not have a
similar type of price improving order.
    \10\ If this results in a price which locks or crosses an away
market, then it will be repriced in accordance with BX Rules at
Chapter VI, Section 7(C).
---------------------------------------------------------------------------

    Today, Price Improving Orders are not displayed at their limit
price, and Participants are unable to ascertain the BX BBO with
certainty. The removal of the Price Improving order type will result in
greater transparency. In addition, BX recently received approval for a
new auction mechanism, PRISM, which offers Participants an alternative
means of entering price improving interest.\11\
---------------------------------------------------------------------------

    \11\ See note 4.
---------------------------------------------------------------------------

Post-Only Orders
    With the removal of Post-Only Orders, market participants would not
be able to submit orders or quotes priced between the MPV; those orders
would be rejected. Other options exchanges currently do not offer a
similar order type.\12\ The Exchange believes that the removal of the
Post-Only Order does not otherwise create an impediment to a free and
open market. The Exchange believes this proposed amendment is non-
controversial. By not accepting Post-Only Orders, BX's true BBO will be
transparent. All orders will be disseminated at the prices and sizes
submitted by market participants at the time of entry into the
System.\13\ The Exchange believes that market participants will
continue to quote at their best prices and the market will be more
transparent. The Exchange believe that despite the removal of the
availability and use of Post-Only Orders, the Exchange will remain
competitive.
---------------------------------------------------------------------------

    \12\ See Phlx and BOX Options Exchange LLC, which do not have a
similar type of post-only order.
    \13\ See note 10.
---------------------------------------------------------------------------

    Today, Post-Only Orders are not displayed at their limit price, and
Participants are unable to ascertain the BX BBO with certainty. The
removal of the Post-Only order type will result in greater
transparency. With the removal of both the Price-Improving order type
and Post-Only order type, the remaining order types will be displayed.
    The Exchange's removal of Price Improving and Post-Only Orders will
reduce the complexity surrounding the repricing of such non-displayed
order types within the auction mechanism. The Exchange's proposal would
result in all orders being displayed on BX and the elimination of non-
displayed order types. Notwithstanding the foregoing, the BBO shall be
the Best Bid or Best Offer on BX. The BBO is repriced and displayed in
accordance with BX Rules at Chapter VI, Section 7(C).

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange does not believe
that the proposal to remove Price Improving Orders as an acceptable
Order type creates an undue burden on inter-market competition because
despite the removal of Price Improving Orders, BX will remain
competitive. By not accepting Price Improving Orders, BX's true BBO
will be more transparent. Orders will be disseminated at the prices and
sizes submitted by market participants at the time of entry into the
System. Market participants would not be able to submit orders or
quotes priced between the MPV.
    The Exchange does not believe that the proposal to remove Post-Only
Orders as an acceptable order type creates an undue burden on inter-
market competition because despite the removal of Post-Only Orders, BX
will remain competitive. Similarly, by not accepting Post-Only Orders,
BX's true BBO will be more transparent. Orders will be disseminated at
the prices and sizes submitted by market participants at the time of
entry into the System. Market participants would not be able to submit
orders or quotes priced between the MPV with the removal of this order
type.
    The Exchange does not believe that the proposal to remove Price
Improving Orders and Post-Only Orders as acceptable order types creates
an undue burden on intra-market competition because the proposed rule
change would thereby remove Price Improving Orders and Post-Only Orders
as acceptable order types for orders enters into BX's System for all
market participants.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \14\ and Rule 19b-4(f)(6) \15\
thereunder.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \16\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \17\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
the filing can be operative prior to the implementation of BX PRISM.
The Exchange states that it intends to launch the newly approved BX
PRISM auction without the ability to enter either of these order types.
The Exchange further states that BX PRISM will benefit from the
transparency of the orders entered into the auction. The Exchange also
states that the removal of Post-Only Orders and Price-Improving Orders
will reduce complexity surrounding the repricing of such non-displayed
order types within BX PRISM. The Commission believes that waiver of the
30-day operative delay is appropriate so that Post-Only Order and
Price-Improving Orders may be removed as order types on the Exchange
prior to the implementation of BX PRISM. Based on the foregoing, the
Commission

believes that the waiver of the operative delay is consistent with the
protection of investors and the public interest.\18\ The Commission
hereby grants the waiver and designates the proposal operative upon
filing.
---------------------------------------------------------------------------

    \16\ 17 CFR 240.19b-4(f)(6).
    \17\ 17 CFR 240.19b-4(f)(6)(iii).
    \18\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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.

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 No. SR-BX-2015-64 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 No. SR-BX-2015-64. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing 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 No. SR-BX-2015-64, and should be
submitted on or before December 3, 2015.
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-28692 Filed 11-10-15; 8:45 am]
BILLING CODE 8011-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:  	30/OCT/2007

Subject:	Flumioxazin.  Acute and Chronic Dietary (Food and Water) Exposure Assessments for Section 3 Registration for Tolerances in/on Alfalfa, Asparagus, Dry Beans, Fruiting Vegetables (Group 8, including Okra), Melon (Subgroup 9A), Bushberries (Subgroup 13B), and Tree Nuts (Group 14).

Petition Numbers:			6F7092, 6E7151

Regulatory Citation:			40CFR §180.568

PC Code (Chemical Number):	129034

DP Number:				342753

Chemical Class:			N-phenylphthalimide Herbicide

Trade Names:			Chateau(

EPA Registration Numbers:	59639-119

From:		Debra Rate, PhD, Biologist

Alternative Risk Integration and Assessment (ARIA) Team

Risk Integration, Minor Use and Emergency Response (RIMUER) Branch

Registration Division (7505P)

Through:	Sheila Piper, Chemist

David Soderberg, Chemist

Dietary Exposure Science Advisory Council

Health Effects Division (7509P)

		William Cutchin, Acting Senior Branch Scientist

		ARIA

		RIMUERB/RD (7505P)

To:		Daniel Rosenblatt, Branch Chief

	RIMUERB

		RD (7505P)

	Joanne Miller / James Stone

	Herbicide Branch (HB)/RD (7505P)

Executive Summary

The purpose of this memorandum is to report the results of a dietary exposure analysis for flumioxazin.  In this analysis, the acute and chronic dietary exposure and risk estimates resulting from food and water intake were determined for the general U.S. population and various population subgroups.

Acute and chronic dietary risk assessments were conducted using the Dietary Exposure Evaluation Model (DEEM-FCID(, Version 2.03), which uses food consumption data from the USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994 to 1996, and 1998.  These analyses were performed to support Section 3 requests(PP#6F7092 and 6E7151) to establish tolerances for residues of flumioxazin in/on alfalfa, asparagus, bean, dry seed, fruiting vegetables (group 8, including okra), melon (subgroup 9a), tree nuts (group 14) and a number of berry crops.

Both the acute and chronic exposure analyses were based on the following assumptions which result in conservative estimates of dietary exposure and risk:

Tolerance level residues of flumioxazin in/on all current RACs (e-CFR 40 §180.568, Updated Sept. 6, 2007) and recommended tolerance level residues of proposed RACs (DP Num: 342963, D. Rate, pending).

Empirical processing factors obtained from processing studies (when available; including tomato commodities).

DEEM 7.81 default processing factors were used for the remaining processed commodities.

100% crop treated (CT), and

0.048 ppm flumioxazin estimated drinking water concentrations (EDWCs) (DP Num: D336195, 342249, 331732; L. Liu; 25/SEP/2007).

In calculating dietary risk estimates, ARIA has compared both the acute population-adjusted dose (aPAD) and the chronic population-adjusted dose (cPAD) to the respective estimated dietary exposures.  Typically, ARIA has concerns regarding dietary risk when the estimates exceed 100% of the aPAD or cPAD.  With the conservative assumptions noted above, risk estimates associated with dietary exposure to flumioxazin are significantly below ARIA’s level of concern.

Acute Dietary Exposure Results and Characterization.

The EDWCs used in the acute dietary exposure was determined to be 0.048 ppm (ground water) by the Environment Fate and Effects Division (EFED) based on residues from flumioxazin (parent compound, 482-HA and APF) (See Attachment 4).  An acute endpoint was selected for only one population subgroup, females 13-49.  This subgroup had a risk estimate below ARIA’s level of concern, utilizing 8% of the aPAD at the 95th percentile of exposure.

Chronic Dietary Exposure Results and Characterization.

The EDWCs used in the chronic dietary exposure, because it was the most conservative, was the same as that used in the acute dietary exposure assessment (0.048 ppm (ground water)).  The general US population and all population subgroups had risk estimates below ARIA’s level of concern.  The most highly exposed population subgroup (all infants <1) utilizes 18% of the cPAD, while the general US population utilizes 6%.

Cancer Exposure Results and Characterization:

Flumioxazin was classified as “Not likely to be Carcinogenic to Humans”, therefore, no cancer assessment was performed.

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For both acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population adjusted dose (PAD).  The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, ARIA is concerned when estimated dietary risk exceeds 100% of the PAD.  ARIA is generally concerned when estimated cancer risk exceeds one in one million (the risk exceeds 1 x 10-6).  References which discuss the acute and chronic risk assessments in more detail are available on the EPA/Pesticides web site, Available Information on Assessing Exposure from Pesticides, A User’s Guide, 21/JUN/2000 (the web link is http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf), or see SOP 99.6 of 20/AUG/1999.

The most recent dietary risk assessment conducted for flumioxazin was Flumioxazin.  Acute and Chronic Dietary Exposure Assessments for Tolerances (Associated with Section 18 Registration) in/on Pumpkins; DP Num: 331788; D. Rate; 22/AUG/2006.  This assessment includes pumpkin (0.02 ppm) in the RACs used for dietary assessment.

II.	Residue Information

Tolerances are currently established for residues of the herbicide flumioxazin in/on various plant commodities, at levels ranging from 0.02 to 0.70 ppm (as listed in 40CFR §180.568[a]).  Previously, residue data from field trials conducted to support the existing registrations show that, generally, residues of flumioxazin are low, and that residues do not concentrate into processed products; therefore, use of default processing factors in the analysis is considered conservative and will overestimate dietary exposure.  In conjunction with these new uses, ARIA recommends in favor of establishing tolerances on the following commodities at the levels listed:

Alfalfa, forage	1.1 ppm

Alfalfa, hay	3.0 ppm

Asparagus	0.02 ppm

Fruiting Vegetables, Group 8 	0.02 ppm

Okra 	0.02 ppm

Melon, subgroup 9A	0.02 ppm

Bean, dry, seed	0.05 ppm

Tree Nuts, Group 14	0.02 ppm

Bushberry, subgroup 13B	0.02 ppm

Aronia berry	0.02 ppm

Blueberry, lowbush	0.02 ppm

Blueberry, highbush	0.02 ppm

Buffalo currant	0.02 ppm

Chilean guava	0.02 ppm

Currant, black	0.02 ppm

Currant, red	0.02 ppm

Elderberry	0.02 ppm

European barberry	0.02 ppm

Gooseberry	0.02 ppm

Highbush cranberry	0.02 ppm

Honeysuckle	0.02 ppm

Jostaberry	0.02 ppm

Juneberry, including Saskatoon berry	0.02 ppm

Lingonberry	0.02 ppm

Native currant	0.02 ppm

Salal	0.02 ppm

Sea buckthorn	0.02 ppm

The residue of concern for both the tolerance expression and risk assessment is flumioxazin per se.  Current and recommended tolerance-level residues were used for all RACs.  DEEM( 7.81 processing factors were used for all processed commodities, with the exception of tomato which used the empirical processing factor of one.  The tomato processing factor of one is based on an exaggerated (~5x) crop field trial study in which no residues were recovered; therefore, a processing study is not required (47005106.der.com, D. Rate, 19/JUN/2007).  One hundred %CT was assumed for all commodities in this assessment.

III.	Drinking Water Data

The EDWCs for flumioxazin residues (flumioxazin, 482-HA, and APF) used in this dietary risk assessment was obtained from EFED’s environmental risk assessment for flumioxazin, Drinking Water Assessment for: (1) IR-4 Registration for Flumioxazin to be used on Asparagus, Dry Bean, Bushberry Subgroup 13B, Fruiting Vegetable Subgroup 8, Melon Subgroup 9A, Okra and Tree Nut Subgroup 14; and (2) Section 3 Registration for Use on Field Corn and Alfalfa; DP Num: D336195, 342249, 331732; L. Liu; 25/SEP/2007.  The hydrolysis study for flumioxazin indicates that flumioxazin forms the metabolite 482-HA, which can further hydrolyze to the metabolites APF and THPA.  The rates of the two hydrolytic reactions are very pH dependent, but flumioxaxin (parent compound) is not very stable at any likely environmental pH.  Data also indicates that THPA and APF are likely to be very mobile.  Although THPA can comprise a major portion of the total residue in water, it does not possess the phenyl ring and is thus considered significantly less toxic than parent, APF, and 482-HA.  Thus, THPA has not been included in the residue of concern for drinking water.  Therefore, parent flumioxazin and the metabolites 482-HA and APF are the residues of concern in drinking water.  The EDWCs for flumioxazin residues (used in both the acute and chronic dietary analyses) was 0.048 ppm, the concentration in groundwater as estimated by the SCI-GROW model.  SCI-GROW (Screening Concentration In GroundWater) is an empirical model for predicting pesticide levels in groundwater; the value from SCI-GROW is considered an upper bound concentration estimate, and thus conservative.  In order to be conservative with the estimates, the groundwater EDWC (0.048 ppm), greater than the surface water EDWC (0.034 ppm), was used in both dietary analyses.  Table 1 summarizes the drinking water concentrations provided by EFED.  The model and its description are available at the EPA internet site:   HYPERLINK "http://www.epa.gov/oppefed1/models/water/"  http://www.epa.gov/oppefed1/models/water/ .

Table 1.  EDWCs for flumioxazin and its degradates in surface water and groundwater at pH 7.

Compound	Average 56-Day Conc. in  Surface Water	Peak Conc. in Surface Water	Conc. in Groundwater

Flumioxazin	negligible	1.03 ppb	negligible

482-HA	4.84 ppb	6.87 ppb	45.27 ppb

APF	12.85 ppb	26.46 ppb	2.66 ppb

THPA	19.50 ppb	27.67 ppb	182.28 ppb

IV.	DEEM-FCID( Program and Consumption Information

Flumioxazin acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID™,Version 2.03 which incorporates consumption data from USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food form (such as orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form.  The resulting residue consumption estimate for each food/food form is summed with the residue consumption estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

For acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.  In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis.  However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

V.	Toxicological Information

The findings of the flumioxazin risk assessment team, relative to dietary exposure, are summarized in Table 2 (below).  In accordance with the EPA Draft Guidelines for Carcinogen Risk Assessment (July, 1999), flumioxazin was classified as “not likely to be carcinogenic to humans.”  As such, both acute and chronic dietary analyses are required, while a cancer dietary analysis is not.

Table 2  Summary of Toxicological Doses and Endpoints for Use in Human Health Dietary

Risk Assessment for Flumioxazin.

Exposure/

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	RfD, PAD, Level of Concern 	Study and Toxicological Effects

Acute Dietary (General Population, including Infants and Children)	No endpoint attributable to a single dose (exposure) was identified in the available studies, including the developmental toxicity studies in rats and rabbits.

Acute Dietary

(Females 13-49 years of age)	NOAEL = 3 mg/kg/day

	UFA= 10x

UFH= 10x

FQPA SF = 1X

Total UF = 100X

	Acute RfD =

NOAEL ( UF =

0.03 mg/kg/day

aPAD = 0.03 mg/kg/day	Oral developmental and supplemental prenatal studies in the rat.

LOAEL = 10 mg/kg/day based on cardiovascular effects (especially ventricular septal defects in fetuses).

Chronic Dietary (All Populations)	NOAEL = 2 mg/kg/day

	UFA= 10x

UFH= 10x

FQPA SF = 1X

Total UF = 100X

	Chronic RfD ( FQPA SF = 0.02 mg/kg/day

cPAD = 0.02  mg/kg/day	2-year chronic/carcinogenicity study in the rat.

LOAEL = 18 mg/kg/day based on increased chronic nephropathy in males, and decreased hematological parameters in females (Hgb, MCV, MCH, and MCHC).

Cancer (oral, dermal, inhalation)   	Classification: “Not likely to be Carcinogenic to Humans” based on the lack of carcinogenicity in a 2-year rat study, an 18-month mouse study, and a battery of mutagenic studies.

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and  used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (intraspecies).  UFH = potential variation in sensitivity among members of the human population (interspecies).  UFL = use of a LOAEL to extrapolate a NOAEL.  UFS = use of a short-term study for long-term risk assessment.  UFDB = to account for the absence of key data (i.e., lack of a critical study).  FQPA SF = FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c = chronic).  RfD = reference dose.  LOC = level of concern.  N/A = not applicable.

VI.	Results/Discussion

As stated above, for acute or chronic dietary assessments, ARIA is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID( analyses estimate the dietary exposure of the US population and various population subgroups.  The results reported in Table 3 (below) are for the general US population (total), all infants <1, children 1-2, children 3-5, children 6-12, youths 13-19, females 13-49, adults 20-49, and adults 50+ for chronic exposure and females 13-49 for acute exposure.

Acute.  The analysis summarized in Table 3 (below) is based on tolerance-level residues in all RACs (modified by DEEM( processing factors, Version 7.81, for processed commodities, except for tomato), and 100% CT assumptions.  Dietary exposure via drinking water was also included in this assessment.  Even with the conservative assumptions utilized, the risk estimate is well below ARIA’s level of concern.  The only population subgroup analyzed is females 13-49, which has an exposure estimate of 0.002524 mg/kg/day at the 95th percentile, and utilizes 8% of the aPAD.

Chronic.  The analyses summarized in Table 3 (below) are based on tolerance-level residues in all RACs (modified by DEEM( processing factors, Version 7.81, for processed commodities, except for tomato), and 100% CT assumptions.  Dietary exposure via drinking water was also included in these assessments.  Even with the conservative assumptions utilized, the risk estimates are well below ARIA’s level of concern.  The most highly exposed population subgroup is all infants <1, which has an exposure estimate of 0.003689 mg/kg/day, and utilizes 18% of the cPAD.

TABLE 3	Summary of Dietary Exposure and Risk for Flumioxazin.

Population Subgroup 1

[Years of Age]

DEEM Acute Dietary Analysis,

95th Percentile

DEEM Chronic Dietary Analysis

aPAD (mg/kg)

Exposure (mg/kg/day)

% aPAD

cPAD (mg/kg/day)

Exposure (mg/kg/day)

% cPAD

General US Population

NA 2

0.02

0.001207

6

All Infants [<1]

0.02

0.003689

18

Children [1-2]

0.02

0.002168

11

Children [3-5]

0.02

0.001958

10

Children [6-12]

0.02

0.001299

7

Youths [13-19]

0.02

0.000900

5

Adults [20-49]

0.02

0.001076

5

Adults [50+]

0.02

0.001121

6

Females [13-49]

0.03

0.002524

8

0.02

0.001076

5

1 Values for the population with the highest risk for each type of risk assessment are bolded.

2 NA = Not Applicable; no acute dietary endpoint was identified for these population subgroups.

VII.	Characterization of Inputs/Outputs

The assumptions made in this assessment are conservative, and are very likely to result in exposure and risk values that considerably overestimate actual dietary exposure to flumioxazin.

VIII.	Conclusions

Based on conservative assumptions, dietary risk estimates for flumioxazin do not exceed ARIA’s level of concern for the general US population, nor any of the population subgroups, including those comprised of infants and children.

IX.	List of Attachments

Attachment 1:  Acute and Chronic Residue Input for Flumioxazin using DEEM-FCID

Attachment 2:  Results of Acute Dietary Exposure Analysis

Attachment 3:  Results of Chronic Dietary Exposure Analysis

Attachment 4:  Chemical Structure of Flumioxazin and metabolites (AFP and 482-HA)

cc:	William Cutchin and Debra Rate

Attachment 1:  Commodity Contribution List for Flumioxazin

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for FLUMIOXAZIN                        1994-98 data

Residue file: E:\ARIA-Flumioxazin\DEEM\129034-090607.R98   Adjust. #2 NOT used

Analysis Date 09-06-2007             Residue file dated: 09-06-2007/15:02:43/8

Reference dose (RfD) = 0.02  (NOEL) = 2 mg/kg bw/day

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

14000030 14   Almond                             0.020000   1.000      1.000   May 2004 new uses

14000031 14   Almond-babyfood                    0.020000   1.000      1.000   May 2004 new uses

14000040 14   Almond, oil                        0.020000   1.000      1.000   May 2004 new uses

14000041 14   Almond, oil-babyfood               0.020000   1.000      1.000   May 2004 new uses

11000070 11   Apple, fruit with peel             0.020000   1.000      1.000

11000080 11   Apple, peeled fruit                0.020000   1.000      1.000

11000081 11   Apple, peeled fruit-babyfood       0.020000   1.000      1.000

11000090 11   Apple, dried                       0.020000   8.000      1.000

11000091 11   Apple, dried-babyfood              0.020000   8.000      1.000

11000100 11   Apple, juice                       0.020000   1.300      1.000

11000101 11   Apple, juice-babyfood              0.020000   1.300      1.000

11000110 11   Apple, sauce                       0.020000   1.000      1.000

11000111 11   Apple, sauce-babyfood              0.020000   1.000      1.000

12000120 12   Apricot                            0.020000   1.000      1.000

12000121 12   Apricot-babyfood                   0.020000   1.000      1.000

12000130 12   Apricot, dried                     0.020000   6.000      1.000

12000140 12   Apricot, juice                     0.020000   1.000      1.000

12000141 12   Apricot, juice-babyfood            0.020000   1.000      1.000

01030150 1CD  Arrowroot, flour                   0.020000   1.000      1.000   May 2004 new uses

01030151 1CD  Arrowroot, flour-babyfood          0.020000   1.000      1.000   May 2004 new uses

01030170 1CD  Artichoke, Jerusalem               0.020000   1.000      1.000   May 2004 new uses

95000190 O    Asparagus                          0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

06030300 6C   Bean, black, seed                  0.050000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

06030320 6C   Bean, broad, seed                  0.050000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

06030340 6C   Bean, cowpea, seed                 0.050000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

06030350 6C   Bean,  great northern, seed        0.050000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

06030380 6C   Bean, lima, seed                   0.050000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

06030390 6C   Bean, mung, seed                   0.050000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

06030400 6C   Bean, navy, seed                   0.050000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

06030410 6C   Bean, pink, seed                   0.050000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

06030420 6C   Bean, pinto, seed                  0.050000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

13020570 13B  Blueberry                          0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

13020571 13B  Blueberry-babyfood                 0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

14000590 14   Brazil nut                         0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

14000680 14   Butternut                          0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

09010750 9A   Cantaloupe                         0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

09010800 9A   Casaba                             0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

14000810 14   Cashew                             0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

01030820 1CD  Cassava                            0.020000   1.000      1.000   May 2004 new uses

01030821 1CD  Cassava-babyfood                   0.020000   1.000      1.000   May 2004 new uses

12000900 12   Cherry                             0.020000   1.000      1.000

12000901 12   Cherry-babyfood                    0.020000   1.000      1.000

12000910 12   Cherry, juice                      0.020000   1.500      1.000

12000911 12   Cherry, juice-babyfood             0.020000   1.500      1.000

14000920 14   Chestnut                           0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

95001280 O    Cottonseed, oil                    0.020000   1.000      1.000

95001281 O    Cottonseed, oil-babyfood           0.020000   1.000      1.000

11001290 11   Crabapple                          0.020000   1.000      1.000

13021360 13B  Currant                            0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

13021370 13B  Currant, dried                     0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

01031390 1CD  Dasheen, corm                      0.020000   1.000      1.000   May 2004 new uses

08001480 8    Eggplant                           0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

13021490 13B  Elderberry                         0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

14001550 14   Filbert                            0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

14001560 14   Filbert, oil                       0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

03001640 3    Garlic                             0.020000   1.000      1.000   May 2004 new uses

03001650 3    Garlic, dried                      0.020000   9.000      1.000   May 2004 new uses

03001651 3    Garlic, dried-babyfood             0.020000   9.000      1.000   May 2004 new uses

01031660 1CD  Ginger                             0.020000   1.000      1.000   May 2004 new uses

01031661 1CD  Ginger-babyfood                    0.020000   1.000      1.000   May 2004 new uses

01031670 1CD  Ginger, dried                      0.020000   1.000      1.000   May 2004 new uses

13021740 13B  Gooseberry                         0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

95001750 O    Grape                              0.020000   1.000      1.000   May 2004 new uses

95001760 O    Grape, juice                       0.020000   1.200      1.000   May 2004 new uses

95001761 O    Grape, juice-babyfood              0.020000   1.200      1.000   May 2004 new uses

95001770 O    Grape, leaves                      0.020000   1.000      1.000   May 2004 new uses

95001780 O    Grape, raisin                      0.020000   4.300      1.000   May 2004 new uses

95001790 O    Grape, wine and sherry             0.020000   1.000      1.000   May 2004 new uses

14001850 14   Hickory nut                        0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

09011870 9A   Honeydew melon                     0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

13021910 13B  Huckleberry                        0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

11002100 11   Loquat                             0.020000   1.000      1.000

14002130 14   Macadamia nut                      0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

12002300 12   Nectarine                          0.020000   1.000      1.000

08002340 8    Okra                               0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

03002370 3    Onion, dry bulb                    0.020000   1.000      1.000   May 2004 new uses

03002371 3    Onion, dry bulb-babyfood           0.020000   1.000      1.000   May 2004 new uses

03002380 3    Onion, dry bulb, dried             0.020000   9.000      1.000   May 2004 new uses

03002381 3    Onion, dry bulb, dried-babyfood    0.020000   9.000      1.000   May 2004 new uses

12002600 12   Peach                              0.020000   1.000      1.000

12002601 12   Peach-babyfood                     0.020000   1.000      1.000

12002610 12   Peach, dried                       0.020000   7.000      1.000

12002611 12   Peach, dried-babyfood              0.020000   7.000      1.000

12002620 12   Peach, juice                       0.020000   1.000      1.000

12002621 12   Peach, juice-babyfood              0.020000   1.000      1.000

95002630 O    Peanut                             0.020000   1.000      1.000

95002640 O    Peanut, butter                     0.020000   1.890      1.000

95002650 O    Peanut, oil                        0.020000   1.000      1.000

11002660 11   Pear                               0.020000   1.000      1.000

11002661 11   Pear-babyfood                      0.020000   1.000      1.000

11002670 11   Pear, dried                        0.020000   6.250      1.000

11002680 11   Pear, juice                        0.020000   1.000      1.000

11002681 11   Pear, juice-babyfood               0.020000   1.000      1.000

14002690 14   Pecan                              0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

08002700 8    Pepper, bell                       0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

08002701 8    Pepper, bell-babyfood              0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

08002710 8    Pepper, bell, dried                0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

08002711 8    Pepper, bell, dried-babyfood       0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

08002720 8    Pepper, nonbell                    0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

08002721 8    Pepper, nonbell-babyfood           0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

08002730 8    Pepper, nonbell, dried             0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

95002750 O    Peppermint                         0.040000   1.000      1.000   May 2004 new uses

95002760 O    Peppermint, oil                    0.040000   1.000      1.000   May 2004 new uses

14002820 14   Pistachio                          0.020000   1.000      1.000   May 2004 new uses

12002850 12   Plum                               0.020000   1.000      1.000

12002851 12   Plum-babyfood                      0.020000   1.000      1.000

12002860 12   Plum, prune, fresh                 0.020000   1.000      1.000

12002861 12   Plum, prune, fresh-babyfood        0.020000   1.000      1.000

12002870 12   Plum, prune, dried                 0.020000   5.000      1.000

12002871 12   Plum, prune, dried-babyfood        0.020000   5.000      1.000

12002880 12   Plum, prune, juice                 0.020000   1.400      1.000

12002881 12   Plum, prune, juice-babyfood        0.020000   1.400      1.000

01032960 1C   Potato, chips                      0.020000   1.000      1.000   May 2004 new uses

01032970 1C   Potato, dry (granules/ flakes)     0.020000   6.500      1.000   May 2004 new uses

01032971 1C   Potato, dry (granules/ flakes)-b   0.020000   6.500      1.000   May 2004 new uses

01032980 1C   Potato, flour                      0.020000   6.500      1.000   May 2004 new uses

01032981 1C   Potato, flour-babyfood             0.020000   6.500      1.000   May 2004 new uses

01032990 1C   Potato, tuber, w/peel              0.020000   1.000      1.000   May 2004 new uses

01032991 1C   Potato, tuber, w/peel-babyfood     0.020000   1.000      1.000   May 2004 new uses

01033000 1C   Potato, tuber, w/o peel            0.020000   1.000      1.000   May 2004 new uses

01033001 1C   Potato, tuber, w/o peel-babyfood   0.020000   1.000      1.000   May 2004 new uses

09023080 9B   Pumpkin                            0.020000   1.000      1.000   Section 18 Aug. 2006 PP#06IL04

09023090 9B   Pumpkin, seed                      0.020000   1.000      1.000   Section 18 Aug. 2006 PP#06IL04

11003100 11   Quince                             0.020000   1.000      1.000

03003380 3    Shallot                            0.020000   1.000      1.000   May 2004 new uses

06003470 6    Soybean, seed                      0.020000   1.000      1.000

06003480 6    Soybean, flour                     0.020000   1.000      1.000

06003481 6    Soybean, flour-babyfood            0.020000   1.000      1.000

06003490 6    Soybean, soy milk                  0.020000   1.000      1.000

06003491 6    Soybean, soy milk-babyfood or in   0.020000   1.000      1.000

06003500 6    Soybean, oil                       0.020000   1.000      1.000

06003501 6    Soybean, oil-babyfood              0.020000   1.000      1.000

95003520 O    Spearmint                          0.040000   1.000      1.000   May 2004 new uses

95003530 O    Spearmint, oil                     0.040000   1.000      1.000   May 2004 new uses

95003590 O    Strawberry                         0.070000   1.000      1.000

95003591 O    Strawberry-babyfood                0.070000   1.000      1.000

95003600 O    Strawberry, juice                  0.070000   1.000      1.000

95003601 O    Strawberry, juice-babyfood         0.070000   1.000      1.000

95003620 O    Sugarcane, sugar                   0.200000   1.000      1.000   May 2004 new uses

95003621 O    Sugarcane, sugar-babyfood          0.200000   1.000      1.000   May 2004 new uses

95003630 O    Sugarcane, molasses                0.200000   1.000      1.000   May 2004 new uses

95003631 O    Sugarcane, molasses-babyfood       0.200000   1.000      1.000   May 2004 new uses

01033660 1CD  Sweet potato                       0.020000   1.000      1.000

01033661 1CD  Sweet potato-babyfood              0.020000   1.000      1.000

01033710 1CD  Tanier, corm                       0.020000   1.000      1.000   May 2004 new uses

08003740 8    Tomatillo                          0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

08003750 8    Tomato                             0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

08003751 8    Tomato-babyfood                    0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

08003760 8    Tomato, paste                      0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

08003761 8    Tomato, paste-babyfood             0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

08003770 8    Tomato, puree                      0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

08003771 8    Tomato, puree-babyfood             0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

08003780 8    Tomato, dried                      0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

08003781 8    Tomato, dried-babyfood             0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

08003790 8    Tomato, juice                      0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

01033870 1CD  Turmeric                           0.020000   1.000      1.000   May 2004 new uses

14003910 14   Walnut                             0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

86010000 O    Water, direct, all sources         0.048000   1.000      1.000

86020000 O    Water, indirect, all sources       0.048000   1.000      1.000

09013990 9A   Watermelon                         0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

09014000 9A   Watermelon, juice                  0.020000   1.000      1.000   July 2007 PP#6F7092 and 6E7151

01034060 1CD  Yam, true                          0.020000   1.000      1.000

01034070 1CD  Yam bean                           0.020000   1.000      1.000   May 2004 new uses

Attachment 2: Results of Acute Dietary Exposure Analysis

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for FLUMIOXAZIN                         (1994-98 data)

Residue file:<PHONE_NUMBER>07.R98                   Adjustment factor #2 NOT used.

Analysis Date: 09-06-2007/15:04:48    Residue file dated: 09-06-2007/15:02:43/8

NOEL (Acute) =   3.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: ""

======================================================================== =======

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th Percentile

 Exposure  % aRfD     MOE    Exposure  % aRfD     MOE    Exposure  % aRfD     MOE

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

Females 13-49 yrs:

  0.002524    8.41    1188    0.003965   13.22     756    0.006895   22.98     435

Attachment 3: Results of Chronic Dietary Exposure Analysis

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for FLUMIOXAZIN                      (1994-98 data)

Residue file name: E:\ARIA-Flumioxazin\DEEM\129034-090607.R98

                                                 Adjustment factor #2 NOT used.

Analysis Date 09-06-2007/15:03:24     Residue file dated: 09-06-2007/15:02:43/8

Reference dose (RfD, Chronic) = .02 mg/kg bw/day

NOEL (Chronic) = 2 mg/kg bw/day

======================================================================== =======

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg       Margin of   Percent

           Subgroup                       body wt/day   Exposure 1/  of RfD

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

U.S. Population (total)                     0.001207        1,658        6.0%

U.S. Population (spring season)             0.001203        1,663        6.0%

U.S. Population (summer season)             0.001285        1,557        6.4%

U.S. Population (autumn season)             0.001170        1,710        5.8%

U.S. Population (winter season)             0.001168        1,713        5.8%

Northeast region                            0.001118        1,790        5.6%

Midwest region                              0.001229        1,627        6.1%

Southern region                             0.001145        1,747        5.7%

Western region                              0.001360        1,470        6.8%

Hispanics                                   0.001356        1,475        6.8%

Non-hispanic whites                         0.001181        1,693        5.9%

Non-hispanic blacks                         0.001149        1,741        5.7%

Non-hisp/non-white/non-black                0.001435        1,393        7.2%

All infants (< 1 year)                      0.003689          542       18.4%

Nursing infants                             0.001416        1,412        7.1%

Non-nursing infants                         0.004552          439       22.8%

Children 1-6  yrs                           0.001985        1,008        9.9%

Children 7-12 yrs                           0.001227        1,630        6.1%

Females 13-19 (not preg or nursing)         0.000873        2,290        4.4%

Females 20+ (not preg or nursing)           0.001136        1,760        5.7%

Females 13-50 yrs                           0.001128        1,774        5.6%

Females 13+ (preg/not nursing)              0.001163        1,719        5.8%

Females 13+ (nursing)                       0.001589        1,259        7.9%

Males 13-19 yrs                             0.000921        2,172        4.6%

Males 20+ yrs                               0.001039        1,925        5.2%

Seniors 55+                                 0.001122        1,782        5.6%

Children 1-2 yrs                            0.002168          923       10.8%

Children 3-5 yrs                            0.001958        1,021        9.8%

Children 6-12 yrs                           0.001299        1,540        6.5%

Youth 13-19 yrs                             0.000900        2,221        4.5%

Adults 20-49 yrs                            0.001076        1,858        5.4%

Adults 50+ yrs                              0.001121        1,783        5.6%

Females 13-49 yrs                           0.001076        1,858        5.4%

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

Attachment 4:  Chemical Structure of Flumioxazin and metabolites (482-HA and APF) used in the EDWCs.

Chemical Name	Structure

Flumioxazin

2-[7-fluoro-3,4-dihydro-3-oxo-4-(2- propynyl)-2H-1,4-benzoxazin-6-yl]- 4,5,6,7-tetrahydro-1H-isoindole- 1,3(2H)-dione

482-HA

N-[7-fluoro-3-oxo-4-(2-propynyl)- 2H-1,4-benzoxazin-6-yl]-3,4,5,6- tetrahydrophthalamic acid

APF

6-amino-7-fluoro-4-(2-propenyl)- 2H-1,4-benzoxazin-3(4H)-one

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ഀFlumioxazin	Dietary Exposure Assessment	DP Num:	342753

PC Code: 129034		Page:   PAGE  14  of   NUMPAGES  14