[Federal Register: November 19, 2008 (Volume 73, Number 224)]
[Notices]
[Page 69632]
[DOCID:fr19no08-76]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket Nos. RP09-3-000; RP09-7-000; RP09-7-001]

Texas Gas Transmission LLC; Notice of Technical Conference

November 13, 2008.
    Take notice that the Commission will convene a technical conference
in the above-referenced proceedings on Tuesday, December 2, 2008, at 10
a.m. (EDT), in a room to be designated at the offices of the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    The Commission's October 31, 2008 Order \1\ directed that a
technical conference be held to address the issues raised by Texas Gas
Transmission LLC's (Texas Gas) October 1, 2008 tariff filings in (i)
Docket No. RP09-3-000 to establish new Effective Fuel Retention
Percentages and to modify its fuel tracking mechanism, and (ii) in
Docket Nos. RP09-7-000 et al., to implement an experimental fuel
savings sharing mechanism.
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    \1\ Texas Gas Transmission LLC, 125 FERC ] 61,134 (2008).
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    Commission Staff and interested persons will have the opportunity
to discuss all of the issues raised by Texas Gas's tariff filings.
Specifically, Texas Gas should be prepared to address all the concerns
raised in the protests, and if necessary, to provide additional
technical, engineering and operational support for its proposals. Any
party proposing alternatives to Texas Gas's proposals should also be
prepared to similarly support its position.
    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an e-mail to<EMAIL_ADDRESS>or call toll free (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER> with
the required accommodations.
    All interested persons are permitted to attend. For further
information please contact Andrew Knudsen at<PHONE_NUMBER> or e-mail
<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. E8-27411 Filed 11-18-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 167 (Tuesday, August 28, 2012)]
[Notices]
[Pages 51992-51993]
[FR Doc No: 2012-21081]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14368-000--CO]

Catamount Metropolitan District; Notice of Availability of
Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's regulations, 18 CFR Part
380 (Order No. 486, 52 FR 47879), the Office of Energy Projects has
reviewed the application for a small hydropower project exemption for
the Catamount Hydroelectric Project, to be located at the existing
Catamount dam and Lake Catamount in Routt County, near the City of
Steamboat Springs, in the state of Colorado, and has prepared an
Environmental Assessment (EA). In the EA, Commission staff analyzed the
potential environmental effects of the proposed project and concludes
that issuing an exemption for the project, with appropriate
environmental measures, would not constitute a major federal action
significantly affecting the quality of the human environment.
    A copy of the EA is on file with the Commission and is available
for public inspection. The EA may also be viewed on the Commission's
Web site at http://www.ferc.gov using the ``eLibrary'' link. Enter the
docket number excluding the last three digits in the docket number
field to access the document. For assistance, contact FERC Online
Support at<EMAIL_ADDRESS>or toll-free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>.

    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    Any comments should be filed within 30 days from the date of this
notice. Comments may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support. Although the Commission strongly encourages electronic filing,
documents may also be paper-filed.
    To paper-file, mail an original and seven copies to: Kimberly D.
Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street
NE., Washington, DC 20426. Please affix Project No. 14368-000 to all
comments.
    For further information, contact Shana Murray at<PHONE_NUMBER> or
by email at<EMAIL_ADDRESS>
    Dated: August 21, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-21081 Filed 8-27-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 72 (Friday, April 16, 2021)]
[Notices]
[Pages 20188-20189]
[FR Doc No: 2021-07776]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4486-DR; Docket ID FEMA-2021-0001]

Florida; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Florida (FEMA-4486-DR), dated March 25, 2020, and
related determinations.

DATES: This amendment was issued February 2, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, pursuant to the
President's Memorandum to Extend Federal Support to Governors' Use of
the National Guard to Respond to COVID-19 and to Increase Reimbursement
and Other Assistance Provided to States, dated January 21, 2021 and the
President's Memorandum on Maximizing Assistance from the Federal
Emergency Management Agency, dated February 2, 2021 FEMA is amending
the cost-sharing arrangements regarding Federal funds provided under
the authority of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121-5207 (the ``Stafford Act'') for all of
the COVID-19 emergency and major disaster declarations. FEMA is
amending this declaration as follows:

    Federal funds for emergency protective measures (Category B),
including direct Federal assistance, under the Public Assistance
program (Section 403) are authorized at 100 percent of total
eligible costs for work performed from January 20, 2020 through
September 30, 2021.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-07776 Filed 4-15-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 78, Number 59 (Wednesday, March 27, 2013)]
[Notices]
[Pages 18637-18642]
[FR Doc No: 2013-07062]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69210; File No. SR-MIAX-2013-12]

Self-Regulatory Organizations; Miami International Securities
Exchange LLC; Notice of Filing of a Proposed Rule Change Relating to
Obvious Errors in Limit or Straddle States

March 22, 2013.
    Pursuant to the provisions of 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 March 22, 2013, Miami International
Securities Exchange LLC (``MIAX'' or ``Exchange'') filed with the
Securities and Exchange Commission (``SEC'' or ``Commission'') a
proposed rule change as described in Items I, II and III below, which
Items have been prepared by the self-regulatory orgnaization. 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 is filing a proposal to amend Exchange Rule 530, Limit
Up-Limit Down (``LULD''), and to amend Exchange Rule 521, Obvious and
Catastrophic Errors to provide for how the Exchange proposes to treat
erroneous options transactions in response to the Plan to Address
Extraordinary Market Volatility Pursuant to Rule 608 of Regulation NMS,
as it may be amended from time to time (the ``Plan'').
    The text of the proposed rule change is provided in Exhibit 5. The
text of the proposed rule change is also available on the Exchange's
Web site at http://www.miaxoptions.com/filter/wotitle/rule_filing, at
MIAX's principal office, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to amend MIAX Rules 530
and 521 to provide for how the Exchange proposes to treat erroneous
options transactions in response to the Plan.
Background
    Since May 6, 2010, when the markets experienced excessive
volatility in an abbreviated time period, i.e., the ``flash crash,''
the equities exchanges and The Financial Industry Regulatory Authority
(``FINRA'') have implemented market-wide measures designed to restore
investor confidence by reducing the potential for excessive market
volatility.
    Among the measures adopted include pilot plans for stock-by-stock
trading pauses, related changes to the equities

market clearly erroneous execution rules, and more stringent equities
market maker quoting requirements. On May 31, 2012, the Commission
approved the Plan, as amended, on a one-year pilot basis. In addition,
the Commission approved changes to the equities market-wide circuit
breaker rules on a pilot basis to coincide with the pilot period for
the Plan. The Plan is designed to prevent trades in individual NMS
stocks from occurring outside of specified Price Bands. The instant
proposed rule change is intended to adopt MIAX rules that address the
trading of options overlying NMS Stocks that are the subject of the
Plan and its provisions during times of unusual volatility in the
markets.
    The requirements of the Plan are coupled with Trading Pauses to
accommodate more fundamental price moves (as opposed to erroneous
trades or momentary gaps in liquidity). All trading centers in NMS
stocks, including both those operated by Participants and those
operated by members of Participants, are required to establish,
maintain, and enforce written policies and procedures that are
reasonably designed to comply with the requirements specified in the
Plan.
Limit State and Straddle State
    As set forth in more detail in the Plan, Price Bands consisting of
a Lower Price Band and an Upper Price Band for each NMS Stock are
calculated by the Processors. When the National Best Bid (Offer) is
below (above) the Lower (Upper) Price Band, the Processors shall
disseminate such National Best Bid (Offer) with an appropriate flag
identifying it as unexecutable. When the National Best Bid (Offer) is
equal to the Upper (Lower) Price Band, the Processors shall distribute
such National Best Bid (Offer) with an appropriate flag identifying it
as a Limit State Quotation. All trading centers in NMS stocks must
maintain written policies and procedures that are reasonably designed
to prevent the display of offers below the Lower Price Band and bids
above the Upper Price Band for NMS stocks. Notwithstanding this
requirement, the Processor shall display an offer below the Lower Price
Band or a bid above the Upper Price Band, but with a flag indicating
that it is non-executable. Such bids or offers shall not be included in
the National Best Bid or National Best Offer calculations. Trading in
an NMS stock immediately enters a Limit State if the National Best
Offer (Bid) equals but does not cross the Lower (Upper) Price Band.
Trading for an NMS stock exits a Limit State if, within 15 seconds of
entering the Limit State, all Limit State Quotations were executed or
canceled in their entirety. If the market does not exit a Limit State
within 15 seconds, then the Primary Listing Exchange would declare a
five-minute trading pause pursuant to Section VII of the Plan, which
would be applicable to all markets trading the security.
    In addition, the Plan defines a Straddle State as when the National
Best Bid (Offer) is below (above) the Lower (Upper) Price Band and the
NMS stock is not in a Limit State. For example, assume the Lower Price
Band for an NMS Stock is $9.50 and the Upper Price Band is $10.50, such
NMS stock would be in a Straddle State if the National Best Bid were
below $9.50, and therefore nonexecutable and the National Best Offer
were above $9.50 (including a National Best Offer that could be above
$10.50). If an NMS stock is in a Straddle State and trading in that
stock deviates from normal trading characteristics, the Primary Listing
Exchange may declare a trading pause for that NMS stock if such Trading
Pause would support the Plan's goal to address extraordinary market
volatility.
Obvious Error
    The Exchange analyzed in detail the operation of current Exchange
Rule 521 (Obvious and Catastrophic Errors) and determined that it would
be undesirable to apply that Rule to options when the underlying NMS
Stock has entered either a Limit or Straddle State. However, the
Exchange does not believe that it should operate without any protection
against erroneous transactions during these periods. Therefore, the
Exchange proposes that proposed Rule 530(j) apply to erroneous
transactions in options when the underlying NMS Stock has entered
either a Limit or Straddle State only when an erroneous transaction is
due to a verifiable disruption or malfunction of the MIAX System.
    The Exchange proposes to exclude transactions executed during a
Limit or Straddle State from the provisions of MIAX Rule 521, on a one-
year pilot basis, beginning on the date of implementation of the Plan,
except in situations where the affected trade resulted from a
verifiable disruption or malfunction of an Exchange execution,
dissemination, or communication system, as discussed below.
    Current Rule 521 provides a process by which a transaction may be
busted or adjusted when the execution price of a transaction deviates
from the option's theoretical price \3\ by a certain amount.
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    \3\ The Theoretical Price of an option is:
    (1) If the series is traded on at least one other options
exchange the last National Best Bid price with respect to an
erroneous sell transaction and the last National Best Offer price
with respect to an erroneous buy transaction, just prior to the
trade;
    (2) if there are no quotes for comparison purposes, or if the
bid/ask differential of the NBBO for the affected series, just prior
to the erroneous transaction, was at least two times the standard
bid/ask differential as permitted for pre-opening quotes under Rule
603(b)(4), as determined by an Exchange Official; or
    (3) for transactions occurring as part of the Exchange's
automated opening system, the Theoretical Price shall be the first
quote after the transaction(s) in question that does not reflect the
erroneous transaction(s).
    See Exchange Rule 521(b).
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    As discussed above, during a Limit or Straddle State, options
prices may deviate substantially from those available prior to or
following the limit state. The Exchange believes that the application
of this provision to all erroneous transactions that occur during a
Limit or Straddle State would give rise to much uncertainty for market
participants as there is no bright line definition of what the
theoretical price should be for an option when the underlying NMS stock
has an unexecutable bid or offer or both.
    Determining theoretical price in such a situation would be often
times very subjective as opposed to an objective determination giving
rise to additional uncertainty, and Rule 521 provides that if there are
no quotes from other options exchanges for comparison purposes, the
theoretical price will be determined by an Exchange Official. However,
given that options market makers and other industry professionals will
have difficulty pricing options during Limit and Straddle States, the
Exchange does not believe it would be reasonable for an Exchange
Official to derive theoretical prices to be applied to transactions
executed during such unusual market conditions. Accordingly, the
Exchange does not believe that the approach employed under Rule 521,
which by definition depends on a reliable national best bid and offer
in the option, is appropriate for all transactions that occur during a
Limit or Straddle State. The Exchange believes that there is no
reliable basis on which to determine the Theoretical Price of
transactions that occur during a Limit or Straddle State. Accordingly,
proposed Rule 530(j) will not include any provision to adjust the price
of trades that occur during a Limit or Straddle State. Proposed Rule
530(j) will only apply to transactions occurring during Limit and
Straddle States that resulted from a verifiable disruption or
malfunction of an Exchange execution, dissemination, or communication
system, and thus proposed Rule 530(j) will not include

the numerical tables defining Obvious and Catastrophic Errors found in
Rule 521(a). Moreover, the Exchange proposes to exclude the description
of conditions other than a verifiable disruption or malfunction of an
Exchange execution, dissemination, or communication system that give
rise to a review that are included in current Rules 521(c)(2)(v) and
(vi).\4\
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    \4\ Under these rules, which will not be incorporated into
proposed Rule 530(j), parties to a trade may have a trade nullified
or its price adjusted if:
    (v) The trade resulted in an execution price in a series quoted
no bid and for 5 seconds prior to the execution remained no bid
(excluding the quote in question; bids and offers of the parties to
the subject trade that are in any of the series in the same options
class shall not be considered) and at least one strike price below
(for calls) or above (for puts) in the same class were quoted no bid
at the time of the erroneous execution (in which case the trade
shall be nullified); or
    (vi) The trade occurred at a price that is deemed to be an
Obvious Error as defined in Paragraph (a)(1) of this Rule 521.
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    After careful consideration, the Exchange believes the application
of the current rule to all transactions occurring during a Limit or
Straddle State would be impracticable during Limit and Straddle States,
and could produce undesirable effects.
    The Exchange believes that market participants should not be able
to benefit from the time frames allotted to them from the time of the
affected transaction within which they may request a review of their
transactions in these situations. Suspending application of Rule 521
for all transactions occurring during a Limit or Straddle State (except
for erroneous transactions that resulted from a verifiable disruption
or malfunction of an Exchange execution, dissemination, or
communication system, or due to an erroneous quote or print in the
underlying NMS Stock as discussed below) would mitigate two of the
undesirable aspects described above: (i) The moral hazard associated
with granting a second look to trades that went against the market
participant after market conditions have changed and (ii) gaming the
obvious error rule to retroactively adjust market maker quotes by
adjusting the execution price at a later time.
    The Exchange notes that there are additional protections in place
outside of Rule 521 that will continue to safeguard customers. First,
SEC Rule 15c3-5 requires that, ``financial risk management controls and
supervisory procedures must be reasonably designed to prevent the entry
of orders that exceed appropriate pre-set credit or capital thresholds,
or that appear to be erroneous.'' \5\
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    \5\ See Securities and Exchange Act Release No. 63241, 75 FR
69791 (November 15, 2010) (S7-03-10).
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    Secondly, as noted above, the Exchange will cancel unexecuted
market orders in the MIAX System, and will reject market orders
received during a Limit or Straddle State. Additionally, the MIAX
System is designed with a built-in protection mechanism that will never
trade through the NBBO price at the time of receipt of an order by more
than one Minimum Price Variation (``MPV'').\6\ Thus, Exchange
functionality that filters out orders that appear to be erroneous or
are at risk of execution at an erroneous price enhances the protections
provided through LULD Functionality.
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    \6\ This would only happen in the event that the Exchange
receives an Intermarket Search Order (``ISO'') routed to the
Exchange by an away market, in which the sending away market
indicates that it has exhausted its efforts to trade at a better
price than the Exchange's disseminated price and that such ISO can
be executed at a price that is inferior to the then-disseminated
NBBO.
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Reviewable Transactions
    As stated above, the Exchange will review all erroneous
transactions occurring during Limit and Straddle States that resulted
from a verifiable disruption or malfunction of an Exchange execution,
dissemination, or communication system. Accordingly, the Exchange is
proposing to incorporate the relevant portions of Rule 521 into
proposed Rule 530(j) to establish the process for such review. The
Exchange proposes to adopt Commentary .06 to Rule 521, which provides
that transactions in MIAX options that overly an NMS Stock that occur
during a Limit or Straddle State are not subject to review under Rule
521. The Exchange shall apply proposed Rule 530(j) to such
transactions.
    Proposed Rule 530(j)(1)(ii) states that trades will continue to be
subject to an obvious error or catastrophic error review in a Limit or
Straddle State if (A) the trade resulted from a verifiable disruption
or malfunction of an Exchange execution, dissemination, or
communication system that caused a quote/order to trade in excess of
its disseminated size (e.g. a quote/order that is frozen, because of an
Exchange system error, and repeatedly traded) in which case trades in
excess of the disseminated size may be nullified, or (B) the trade
resulted from a verifiable disruption or malfunction of an Exchange
dissemination or communication system that prevented a member from
updating or canceling a quote/order for which the member is responsible
where there is Exchange documentation providing that the member sought
to update or cancel the quote/order; (C) the trade resulted from an
erroneous print disseminated by the underlying market which is later
cancelled or corrected by the underlying market where such erroneous
print resulted in a trade higher or lower than the average trade in the
underlying security during the time period encompassing two minutes
before and after the erroneous print, by an amount at least five times
greater than the average quote width for such underlying security
during the time period encompassing two minutes before and after the
erroneous print. For purposes of this Rule, the average trade in the
underlying security shall be determined by adding the prices of each
trade during the four minute time period referenced above (excluding
the trade in question) and dividing by the number of trades during such
time period (excluding the trade in question); or (D) the trade
resulted from an erroneous quote in the primary market for the
underlying security that has a width of at least $1.00 and that width
is at least five times greater than the average quote width for such
underlying security during the time period encompassing two minutes
before and after the dissemination of such quote. For the purposes of
this Rule, the average quote width shall be determined by adding the
quote widths of sample quotations at regular 15-second intervals during
the four minute time period referenced above (excluding the quote in
question) and dividing by the number of quotes during such time period
(excluding the quote in question).
    Currently, under Rule 521(a)(1) and (2), obvious and catastrophic
errors are calculated by determining a theoretical price and applying
such price, based on objective standards, to ascertain whether the
trade should be nullified or adjusted. While the rule contains a
notification process for requesting an obvious error review, certain
more substantial errors may fall under the category of a catastrophic
error, for which a longer time period is permitted to request a review
and for which trades can currently only be adjusted (not nullified).
Trades are adjusted pursuant to an adjustment table that, in effect,
assesses an adjustment penalty. By adjusting trades above or below the
theoretical price, the Rule assesses a ``penalty'' in that the
adjustment price is not as favorable as the amount the party making the
error would have received had it not made the error.

    Pursuant to current Rule 521(b), the theoretical price of an option
is determined in one of three ways: (1) If the series is traded on at
least one other options exchange, the last National Best Bid price with
respect to an erroneous sell transaction and the last National Best
Offer price with respect to an erroneous buy transaction, just prior to
the trade; (2) if there are no quotes for comparison purposes, or if
the bid/ask differential of the National Best Bid and Offer (``NBBO'')
for the affected series, just prior to the erroneous transaction, was
at least two times the permitted bid/ask differential under Rule
1014(c)(i)(A)(1)(a) [sic], as determined by an Exchange Official; or
(3) for transactions occurring as part of the Exchange's automated
opening system, the theoretical price shall be the first quote after
the transaction(s) in question that does not reflect the erroneous
transaction(s).
    The Exchange believes that none of these three methods is
appropriate during a Limit or Straddle State. Specifically, under Rule
521(b)(1), the theoretical price is determined with respect to the NBBO
for an option series just prior to the trade. As discussed above,
during a Limit or Straddle State, options prices may deviate
substantially from those available prior to or following the State. The
Exchange believes this provision would give rise to much uncertainty
for market participants as there is no bright line definition of what
the theoretical price should be for an option when the underlying NMS
stock has an unexecutable bid or offer or both. Determining theoretical
price in such a situation would be often times very subjective as
opposed to an objective determination giving rise to additional
uncertainty and confusion for investors. Accordingly, the Exchange does
not believe that the approach employed under current Rule 521(b)(1),
which by definition depends on a reliable NBBO in the option, is
appropriate during a Limit or Straddle State. The Exchange believes
that excluding this from proposed Rule 530(j) is appropriate because
while in a Limit or Straddle State, only limit orders will be accepted
by the Exchange, affirming that the participant is willing to accept an
execution up to the limit price. Further, because the Exchange system
will only trade through the theoretical bid or offer if the Exchange or
the participant (via an ISO order) has accessed all better priced
interest away in accordance the Options Order Protection and Locked/
Crossed Markets Plan, the Exchange believes potential trade reviews of
executions that occurred at the participant's limit price and also in
compliance with aforementioned Plan could result in uncertainty that
could harm liquidity and also could create an advantage to either side
of an execution depending on the future movement of the underlying
stock.
    The Exchange recognizes that the second method (in Rule 521(b)(2))
affords discretion to the Options Exchange Official in determining the
theoretical price and thereby, ultimately, whether a trade is busted or
adjusted and to what price. The Exchange has determined that it would
be difficult to exercise such discretion in periods of extraordinary
market volatility and in particular when the price of the underlying
security is unreliable. Moreover, the theoretical price would be
subjective. Thus, the Exchange has determined not to permit an obvious
or catastrophic error review if there are no quotes for comparison
purposes, or if the bid/ask differential of the NBBO for the affected
series, just prior to the erroneous transaction, was at least two times
the permitted bid/ask differential. The Exchange believes that adding
certainty to the execution of orders in these situations should
encourage market participants to continue to provide liquidity to the
Exchange and thus promote a fair and orderly market.
    The Exchange notes that current Rule 521(b)(3) applies to trades
executed during openings. Because the Exchange does not intend to open
an option during a Limit or Straddle State, this provision, on its
face, will not apply.
    For the same reasons, the Exchange is proposing that Rule
521(c)(2)(vi) not apply during a Limit or Straddle State.
    In addition, the Exchange proposes that trades are not subject to
an obvious error and catastrophic error review if pursuant to the
provisions of Rule 521(c)(2)(vi) the trade resulted from an execution
price in a series quoted no bid. A zero bid option refers to an option
where the bid price is $0.00. Series of options quoted zero bid are
usually deep out-of-the-money series that are perceived as having
little if any chance of expiring in-the-money. For this reason,
relatively few transactions occur in these series and those that do are
usually the result of a momentary pricing error.
    Specifically, under this provision, where the trade resulted in an
execution price in a series quoted no bid and for 5 seconds prior to
the execution remained no bid (excluding the quote in question; bids
and offers of the parties to the subject trade that are in any of the
series in the same options class shall not be considered) and at least
one strike price below (for calls) or above (for puts) in the same
class were quoted no bid at the time of the erroneous execution (in
which case the trade shall be nullified). The Exchange believes that
these situations are not appropriate for an error review because they
are more likely to result in a windfall to one party at the expense of
another in a Limit or Straddle State, because the criteria for meeting
the no-bid provision are more likely to be met in a Limit or Straddle
State, and unlike normal circumstances, may not be a true reflection of
the value of the series being quoted. For example, in a series quoted
$1.95-$2.00 on multiple exchanges prior to the Limit or Straddle State,
an order to B10@ $2.00 is likely a reasonably priced trade because the
buyer attempted to pay $2.00 with a limit price. However, if that
series and the series one strike below are both quoted $0.00- $5.00,
then both the seller and the buyer at $2.00 would have an opportunity
to dispute the trade. This would create uncertainty to both parties and
an advantage to one participant if the underlying stock moved
significantly in their direction.
    Regarding Obvious Errors, the Commission has stated previously that
it ``* * * considers that in most circumstances trades that are
executed between parties should be honored. On rare occasions, the
price of the executed trade indicates an `obvious error' may exist,
suggesting that it is unrealistic to expect that the parties to the
trade had come to a meeting of the minds regarding the terms of the
transaction. In the Commission's view, the determination of whether an
`obvious error' has occurred, and the adjustment or nullification of a
transaction because an obvious error is considered to exist, should be
based on specific and objective criteria and subject to specific and
objective procedures * * *'' \7\
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 49785 (May 28,
2004), 69 FR 32090 (June 8, 2004) (SR-Phlx-2003-68).
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    The Exchange believes that, in some extreme situations, trade
participants may not be aware of errors that result in very large
losses within the time periods currently required under the rule. In
this type of extreme situation, the Exchange believes its members
should be given more time to seek relief so that there is a greater
opportunity to mitigate very large losses and reduce the corresponding
large wind-falls. However, to maintain the appropriate balance, the
Exchange believes members should only be given more time when the
execution price is much further

away from the theoretical price than is required for Obvious Errors so
that relief is only provided in extreme circumstances.
    The Exchange believes that this proposal strikes the aforementioned
balance. The Exchange is proposing to decline to review certain trades,
which is specific and objective. Furthermore, the proposal more fairly
balances the potential windfall to one market participant against the
potential reconsideration of a trading decision under the guise of an
error, and thereby results in more certainty during periods of extreme
market volatility. Trades can nevertheless be considered erroneous
under other sections of the Rule, because those continue to be an
objective method of determining whether an error occurred, even during
periods of extraordinary market volatility. Because the Exchange
intends to continue to review trades pursuant to proposed Rules
521(j)(1)(A)-(D) [sic], the Exchange believes that this continues to
provide some protection to market participants.
    The Exchange believes that, in addition to the built-in customer
protections discussed above, it is necessary to protect investors from
erroneous transactions resulting from a verifiable disruption or
malfunction of an Exchange execution, dissemination, or communication
system.
    Proposed Rule 530(j) will also include identical language to that
used in current Rule 521 regarding mutual agreement by the parties to
an erroneous transaction during a trading halt, i.e., trades on the
Exchange will be nullified when the trade occurred during a trading
halt in the affected option on the Exchange, or respecting equity
options (including options overlying ETFs), the trade occurred during a
trading halt on the primary market for the underlying security.
Proposed Rule 530(j) will also incorporate the relevant elements of
Rule 521 regarding the review procedure, requests for review, and
appeals from decisions to bust a trade.
    The Exchange has engaged in informal discussions with its members,
and has received generally favorable feedback concerning its proposed
handling of Obvious Errors during Limit and Straddle States, given the
aforementioned built-in protections in the MIAX System.
    During the one-year pilot period beginning on the date of
implementation of the Plan, the Exchange will conduct its own analysis
concerning the elimination of obvious error rules during limit and
straddle states and agrees to provide the Commission with relevant data
to assess the impact of this proposed rule change. As part of its
analysis, the Exchange will evaluate (1) the options market quality
during limit and straddle states, (2) assess the character of incoming
order flow and transactions during limit and straddle states, and (3)
review any complaints from members and their customers concerning
executions during limit and straddle states. Additionally, the Exchange
agrees to provide to the Commission data requested to evaluate the
impact of the elimination of the obvious error rule, including data
relevant to assessing the various analyses noted above.
2. Statutory Basis
    MIAX believes that its proposed rule change is consistent with
Section 6(b) of the Act \8\ in general, and furthers the objectives of
Section 6(b)(5) of the Act \9\ in particular, in that it is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, to remove impediments to and perfect the mechanisms of a
free and open market and a national market system and, in general, to
protect investors and the public interest, and it is not designed to
permit unfair discrimination among customers, brokers, or dealers.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes the application of the current Obvious Error
rule will be impracticable given the lack of a reliable NBBO in the
options market during Limit and Straddle States, and that the resulting
actions (i.e., nullified trades or adjusted prices) may not be
appropriate given market conditions. This change would ensure that
limit orders that are filled during a Limit or Straddle State would
have certainty of execution in a manner that promotes just and
equitable principles of trade, removes impediments to, and perfects the
mechanism of a free and open market and a national market system.
Moreover, given that options prices during brief Limit or Straddle
States may deviate substantially from those available shortly following
the Limit or Straddle State, the Exchange believes giving market
participants time to reevaluate a transaction would create an
unreasonable adverse selection opportunity that would discourage
participants from providing liquidity during Limit or Straddle States.
In this respect, the Exchange notes that by rejecting market orders and
cancelling pending market orders, only those orders with a limit price
will be executed during a Limit or Straddle State. Therefore, on
balance, the Exchange believes that removing the potential inequity of
nullifying or adjusting executions occurring during Limit or Straddle
States outweighs any potential benefits from applying certain
provisions during such unusual market conditions.
    Additionally, as discussed above, there are additional pre-trade
protections in place on the MIAX System that will continue to safeguard
customers.

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.
    Specifically, the Exchange believes the proposed changes will not
impose any burden on intra-market competition because it applies to all
MIAX participants equally. The Exchange does not believe the proposed
rules will impose any burden on inter-market competition as the
proposed rules are intended to protect investors with the
implementation of the Plan. In addition, the proposed changes will
provide certainty of treatment and execution of options orders during
periods of extraordinary market volatility.

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

    Written comments were neither solicited nor received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) By order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule

change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-MIAX-2013-12 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MIAX-2013-12. 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, located at 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 will also be
available for inspection and copying at the principal office of the
Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
MIAX-2013-12 and should be submitted on or before April 8, 2013.\10\
---------------------------------------------------------------------------

    \10\ The Commission believes that a 10-day comment period is
reasonable, given the urgency of the matter. It will provide
adequate time for comment. The Commission also notes that this
proposal is substantially similar to proposals from NASDAQ OMX PHLX
LLC, The NASDAQ Stock Market LLC, and NASDAQ OMX BX, Inc. which were
published for comment in the Federal Register on March 20, 2013. See
Securities Exchange Act Release Nos. 69141 (March 15, 2013), 78 FR
17262 (March 20, 2013) (SR-Phlx-2013-29); 69142 (March 15, 2013), 78
FR 17251 (March 20, 2013) (SR-NASDAQ-2013-048); and 69140 (March 15,
2013), 78 FR 17255 (March 20, 2013) (SR-BX-2013-026).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-07062 Filed 3-26-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 217 (Wednesday, November 9, 2011)]
[Notices]
[Pages 69793-69794]
[FR Doc No: 2011-29048]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of denials.

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SUMMARY: FMCSA announces its denial of 107 applications from
individuals who requested an exemption from the Federal vision standard
applicable to interstate truck and bus drivers and the reasons for the
denials. FMCSA has statutory authority to exempt individuals from the
vision requirement if the exemptions granted will not compromise
safety. The Agency has concluded that granting these exemptions does
not provide a level of safety that will be equivalent to or greater
than the level of safety maintained without the exemptions for these
commercial motor vehicle (CMV) drivers.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs,<PHONE_NUMBER>, U.S. Department of Transportation, FMCSA,
1200 New Jersey Avenue SE., Room W64-224, Washington, DC 20590-0001.
Office hours are from 8:30 a.m. to 5 p.m. Monday through Friday, except
Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal vision standard for a renewable 2-year period if it
finds ``such an exemption would likely achieve a level of safety that
is equivalent to, or greater than, the level that would be

achieved absent such an exemption.'' The procedures for requesting an
exemption are set forth in 49 CFR part 381.
    Accordingly, FMCSA evaluated 107 individual exemption requests on
their merit and made a determination that these applicants do not
satisfy the criteria eligibility or meet the terms and conditions of
the Federal exemption program. Each applicant has, prior to this
notice, received a letter of final disposition on the exemption
request. Those decision letters fully outlined the basis for the denial
and constitute final Agency action. The list published in this notice
summarizes the Agency's recent denials as required under 49 U.S.C.
31315(b)(4) by periodically publishing names and reasons for denial.
    The following 9 applicants lacked sufficient driving experience
during the 3-year period prior to the date of their applications:

Mark Seyler
Dwight H. Pease
John F. Monette
Dennis Joe Crandall
Sergio Alvarez Ruiz
Keith Raymond Hughes
Timothy T. Stapleton
Andrew Fletcher Hill
Larry Periman

    The following 9 applicants had no experience operating a CMV:

William J. Smith
Drew Buss
A.D. Alexander
Joshua Wayne Crosby
Samuel Brown, Jr.
James Norbert Fisher
Adewale A. Haastrup
David G. Thoroughn
Daniel Ramse

    One applicant, William Kraemer, did not have 3 years of experience
driving a CMV on public highways with the vision deficiency:
    The following 18 applicants did not have 3 years of recent
experience driving a CMV with the vision deficiency:

Norman Donald Hursey
Timothy Allen Easter, Sr.
James Muldoon
Jeffrey Roughton
John E. Humphery
Douglas Claxton
James Roscoe Brittain III
Jerry M. Puckett
Larry Dexter
Georgia Marcum
John Darr
Kevin Menard
Christopher Jax
Charles Ray Brittain
Kevin Robert Cowger
Clifford Blaine Thompson
Timothy Garland
Kevin Barker

    The following 14 applicants did not have sufficient driving
experience during the past 3 years under normal highway operating
conditions:

Jose P. Martinez
Phillip Gene Roberts
Dennis Wayne Vaughn
John Gramling
Larry Ventimiglia
Bret Harold Bulcher
Daniel John Hodges
Douglas Stanley
Steven F. Albro
Nathan W. Sears
Michael Wayne Gilley
William C. Miller
Darrell Prather
James Jaramillo

    One applicant, Robert J. Moore, Jr., was charged with moving
violation(s) in conjunction with a commercial motor vehicle
accident(s). This is a disqualifying offense.
    One applicant, Gregory Busche, does not have sufficient peripheral
vision in the better eye to qualify for an exemption.
    The following applicant, Randy Fielder, had a commercial driver's
license suspension during the 3-year review period for moving
violations. Applicants do not qualify for an exemption with a
suspension during the 3-year period.
    The following 2 applicants contributed to accident(s) in which the
applicant was operating a commercial motor vehicle. This is a
disqualifying offense.

David Lynn Ellis
Mark John Cairns

    The following 11 applicants were denied for miscellaneous/multiple
reasons:

Mark Don Morrishow
Manuel DeJesus Luna
Frank James Means
Cameron M. Chauvin
Jeffery Wayne Vaughan
James Loyde Meisner
David Wayne Trawick
Robert Fortune
Thomas Keith Wagner
William Kenneth Griffin
Erasmus Okonkwo Odili

    The following 2 applicants were denied because their vision was not
stable for the entire 3-year period.

Barry Lee Crenshaw
Daniel J. Piechocki

    The following 2 applicants were denied because they do not meet the
vision standard in the better eye:

William R. Connolly
Jose A. Guevara

    One applicant, Roger Doyle, was denied because his CDL was
suspended during the 3-year period in relation to an accident. The
accident may or may not be related to his medical condition.
    The following 4 applicants met the current federal vision
standards. Exemptions are not required for applicants who meet the
current regulations for vision:

Edward A. Bechtel
Donald Class
Terry Alvin Leffler
Terry Lee Engelhardt

    The following 22 applicants were denied because they will not be
driving interstate, interstate commerce, or not required to carry a DOT
medical card:

Kary Lee Montour
Ryan M. Wagner
Shawn Michael Priess
Carlos R. Gonzalez
Jerard David Menyhart
Danny Michael Harris
Kevin Palmer
Moises P. Ibarra
Jeffery O. Nischwitz
Danny Ray Haner
Orenthal Arnelle Kellam
Larry Lee Dorrance
Lloyd Edward Bean
Michael Young
Raymond Miller
Ruben Armando Gallardo
Paul Anthony Castillo
Warren Vernon Hopper
Jose Marisco
Thomas B. Bliven
Michael Jacson
Larry E. Markowski

    Finally, the following 9 applicants perform transportation for the
federal government, state, or any political sub-division of the state.

Jimmy Dale Johnson, II
Wesley R. Jackson
Hilliard Whitehead
Mark S. Miller
John Matthew Holder
Gerald E. Thomas, Jr.
Edward Lee Talbert
Debra V. Bryant
Alonzo Bailey

    Issued on: October 28, 2011.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2011-29048 Filed 11-8-11; 8:45 am]
BILLING CODE 4910-EX-P


Glyphosate NOF Aug2005 Page 1 of 15 Monsanto Company authorizes the EPA to publish the following summary of the petition to comply with the Food Quality Protection Act of 1996. An electronic copy on computer disc is provided with the cover letter for this submission.

Summary of Petition Petitioner summaries of the pesticide petitions are printed below as required by section 408 ( d) ( 3) of the FFDCA. The summaries of the petitions were prepared by the petitioners and represent the views of the petitioner. EPA is publishing the petitions summaries verbatim without editing them in any way. The petition summary announces the availability of a description of the analytical method available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

Interregional Research Project Number 4 ( IR 4)

PP [ ]

EPA has received a pesticide petition ( PP ) from Interregional Research Project Number 4 ( IR 4), 681 U. S. Highway # 1 South, North Brunswick, NJ 08902 3390, proposing pursuant to section 408( d) of the Federal Food, Drug and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), as amended by the Food Quality Protection Act of 1996 ( FQPA) ( Public Law 104 170), to amend 40 CFR part 180.364 by revising the existing tolerance regulation for glyphosate [( N phosphonomethyl) glycine].

This petition requests that 40 CFR 180.364 be amended by establishing a tolerance for residues of glyphosate ( N ( phosphonomethyl) glycine) resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, the potassium salt of glyphosate, and the ammonium salt of glyphosate in or on Mulberry, Indian at 0.2 ppm. In addition, PP [ ] requests to revise the present tolerance for Vegetable, legume, group 6, except soybean to 8.0 ppm from the present value of 6.0 ppm. EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

Section 408( b)( 2)( A)( i) of the FFDCA allows EPA to establish a tolerance ( the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is `` safe.'' Section 408( b)( 2)( A)( ii) defines `` safe'' to mean that `` there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408( b)( 2)( C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to `` ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .''

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk Glyphosate NOF Aug2005 Page 2 of 15 assessment process, see the final rule on Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997) ( FRL  5754  7).

A. Residue Chemistry 1. Plant metabolism. The nature of the residue in plants is adequately understood and consists of the parent, glyphosate and its metabolite AMPA ( aminomethyl phosphonic acid). Only glyphosate parent is to be regulated in plant and animal commodities since the metabolite AMPA is not of toxicological concern in food. The qualitative nature of the glyphosate residue will not be changed as a result of the proposed tolerance changes.

The qualitative nature of the residue in animals is adequately understood, and will not be affected by the proposed tolerance change. Glyphosate herbicides are not applied directly to livestock, so their only exposure is via plant residues their diet. The terminal residue to be regulated in livestock is glyphosate per se.

2. Analytical method. Adequate enforcement methods are available for analysis of residues of glyphosate in or on plant commodities. These methods include gas liquid chromatography ( GLC) ( Method I in Pesticides Analytical Manual ( PAM) II; the limit of detection is 0.05 ppm) and High Performance Liquid Chromatography ( HPLC) with fluorometric detection. The HPLC procedure has undergone successful Agency validation and was recommended for inclusion in PAM II. A gas chromatography/ mass spectrometry ( GC/ MS) method for glyphosate crops has also been validated by EPA's Analytical Chemistry Laboratory ( ACL). The proposed revisions in the tolerance regulation does not change the residue to be analyzed, which remains as glyphosate per se.

The unpublished methods may be requested from: Calvin Furlow, PRRIB, IRSD ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: ( 703) 305 5229; e mail address: furlow. calvin@ epa. gov.

3. Magnitude of residues. Adequate data concerning glyphosate residues on raw agricultural commodities ( RACs) and relevant processed commodities has been submitted to the Agency. Accordingly, the available residue data for glyphosate support the proposed revisions of the tolerance regulation for glyphosate. In addition, any secondary residues occurring in liver, or kidney of cattle, goats, horses, and sheep, and meat by products of poultry, and eggs, will be covered by existing tolerances. Any residues occurring in harvestable aquatic species will be covered by existing glyphosate tolerances for fish and shellfish.

B. Toxicological Profile EPA has previously evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the acute toxic effects caused by glyphosate have been evaluated by the Agency, but an acute dietary endpoint has not been selected for the general population or for females 13   50, since an appropriate endpoint attributable to a single exposure was not demonstrated. The nature of the subchronic, chronic and other toxic effects caused by glyphosate are summarized in the following Table 1 in addition to the relevant no observed Glyphosate NOF Aug2005 Page 3 of 15 adverse effect levels ( NOAELs) and the lowest observed adverse effect levels ( LOAELs) from the toxicity studies reviewed.

Table 1. Subchronic, Chronic and Other Toxicity Guideline No. Study Type Results 870.3100 90 Day oral toxicity in rats NOAEL less than 50 milligrams ( mg)/ kilogram ( kg)/ day for both sexes LOAEL = 50 mg/ kg/ day based on increased phosphorus and potassium in both sexes 870.3100 90 Day oral toxicity in mice NOAEL = 1,500 mg/ kg/ day in both sexes LOAEL = 7,500 mg/ kg/ day in both sexes based on decreased body weight gain in both sexes. 870.3485 28 Day inhalation toxicity   rat exposure; 6 hours/ day, 5 days/ week for 4 weeks) NOAEL = 0.36 mg/ L, LOAEL = > 0.36 high dose tested ( HDT) mg/ L, not established 870.3200 21 dermal toxicity in rabbits NOAEL = 1,000 mg/ kg/ day for males and 5,000 mg/ kg/ day for females LOAEL = 5,000 mg/ kg/ day in males based on decreased food consumption 870.3700 Prenatal developmental toxicity in rats Maternal NOAEL = 1,000 mg/ kg/ day day based on mortality, LOAEL = 3,500 mg/ kg/ day based on mortality, increased clinical signs, and reduced body weight gain Developmental NOAEL = 1,000 mg/ kg/ day LOAEL = 3,500 mg/ kg/ day based on decreases in total implantations/ dam and nonviable fetuses/ dam, increased number of litters and fetuses with unossified sternebrae, and decreased fetal body weight.

870.3700 Prenatal developmental toxicity in rabbits Maternal NOAEL = 175 mg/ kg/ day LOAEL = 350 mg / kg/ day based on mortality, and clinical signs Developmental NOAEL = 175 mg/ kg/ day LOAEL = 350 mg/ kg/ day ( insufficient litters available to assess developmental toxicity)

870.3800 Reproduction and fertility effects in rats ( 2 generation) Parental/ Systemic NOAEL = 500 mg/ kg/ day for males and females LOAEL = 1,500 mg/ kg/ day for males and females based on clinical signs, decreased body weights, decreased weight gain, and decreased food consumption in both sexes Reproductive NOAEL = > 1500 HDT mg/ kg/ day in males and females LOAEL = > 1500 HDT mg/ kg/ day for males and females, not established Offspring NOAEL = 500 kg/ day for males and females LOAEL = 1500 mg/ kg/ day for males and females based on reduced pup weights in both sexes during second and third weeks of lactation 870.4100 Chronic toxicity in dogs NOAEL = 500 HDT mg/ kg/ day in Glyphosate NOF Aug2005 Page 4 of 15 males and females LOAEL = > 500 mg/ kg/ day in males and females, not established 870.4300 Combined Chronic Toxicity/

Carcinogenicity in rats NOAEL = 362 mg/ kg/ day in males and 457 mg/ kg/ day in females LOAEL = 940 mg/ kg/ day in males and 1,183 kg/ kg/ day in females based on decreased weight gain in females, and increased incidence of cataracts and lens abnormalities, decreased urinary pH, increased absolute liver weight, and increased relative liver weight/ brain weight in males. No evidence of carcinogenicity.

870.4300 Carcinogenicity in mice NOAEL = 750 mg/ kg/ day in males and females LOAEL = 4,500 mg/ kg/ day in both sexes based on decreased body weight gains in both sexes, increased incidence of renal proximal tubule epithelial basophilia and hypertrophy in females and increased incidence of interstitial nephritis, hepatocellular hypertrophy and hepatocellular necrosis in males. No evidence of carcinogenicity.

870.5100 Gene mutation assay in S. typhimurium strains Negative   non mutagenic when tested up to 1000 [ mu] g/ plate in the presence and absence of activation in S. typhimurium TA98, TA100, TA1535, and TA1537 870.5100 Gene mutation assay in E. coli and S. typhimurium strains Negative for reverse gene mutation, both with and without S 9, up to 5000 [ mu] g/ plate ( or cytotoxicity) with E. coli WP2hcrA and S. typhimurium TA98, TA100, TA1535, TA1537, and TA1538 870.5300 In vitro gene mutation assay in Chinese hamster ovary cells/ HGPRT Negative   non mutagenic at the HGPRT locus in Chinese hamster ovary cells tested up to cytotoxic concentrations or limit of solubility, in presence and absence of activation 870.5385 Cytogenetics   In vivo bone marrow chromosome aberrations assay Negative   non mutagenic in the rat bone marrow chromosome assay up to 1,000 mg/ kg in both sexes of Sprague Dawley rats 870.5550 Other mechanisms   in vitro rec assay with B. subtilis There was no evidence of recombination in the rec assay up to 2000 [ mu] g/ plate with B. subtilis H17 ( rec+) and M45 H17 ( rec+) and M45 ( rec)( rec)

870.6200 Acute neurotoxicity screening battery in rats Not required 870.6200 Subchronic neurotoxicity screening battery Not required 870.6300 Developmental neurotoxicity in rats Not required 870.7485 Metabolism in rats Following a single oral dose, 30 36% was absorbed and less than 0.27% was eliminated asCO2. Urine and feces contained 97.5% as Glyphosate NOF Aug2005 Page 5 of 15 parent. Aminomethylphosphonic acid ( AMPA) was only metabolite found at 0.2 0.3% of administered dose. Less than 1.0% of the absorbed dose remained in tissues and organs, primarily in the bone.

870.7600 Dermal Penetration Not required Endocrine disruption The above studies measure numerous endpoints with sufficient sensitivity to detect potential endocrine modulating activity. No effects have been identified in subchronic, chronic or developmental toxicity or multi generation reproduction studies to indicate any endocrine modulating activity by glyphosate. In addition, no adverse were not seen when glyphosate was tested in a dominant lethal mutation assay. While this assay was designed as a genetic toxicity test, agents that can affect male reproduction function will also cause effects in this assay.

C. Toxicological Endpoints The dose representing the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern ( LOC). However, the lowest dose at which adverse effects of concern are identified ( the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor ( UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

For dietary risk assessment ( other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose ( acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF ( RfD = NOAEL/ UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose ( aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor.

For non dietary risk assessments ( other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF ( 10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures ( margin of exposure ( MOE) = NOAEL/ exposure) is calculated and compared to the LOC.

The linear default risk methodology ( Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases ( e. g., risk is expressed as 1 x 10  6 or one in a million). Glyphosate NOF Aug2005 Page 6 of 15 Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non linear approach, a    point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure ( MOEcancer = point of departure/ exposures) is calculated. A summary of the toxicological endpoints for glyphosate used for human risk assessment is shown in the following Table 2:

Table 2. Summary of Toxicological Dose and Endpoints for Glyphosate for Use in Human Risk Assessment Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary ( females 13   50 years old and general population) None Not applicable There were no effects that could be attributed to a single exposure ( dose) in oral toxicity studies including the developmental toxicity studies in rats and rabbits Chronic Dietary ( all populations) NOAEL = 175 mg/ kg/ day; UF = 100; Chronic RfD = 1.75 mg/ kg/ day FQPA SF = 1; cPAD = cRfD FQPA SF = 1.75 mg/ kg/ d Developmental toxicity in rabbits Maternal LOAEL = 350 mg/ kg/ day based on diarrhea, nasal discharge, and mortality Developmental toxicity was not observed at any dose tested. Short term,

Intermediateterm incidental oral ( Residential) NOAEL = 175 mg/ kg/ day LOC for MOE = 100 Developmental toxicity in rabbits Maternal LOAEL = 350 mg/ kg/ day based on diarrhea, nasal discharge, and mortality Developmental toxicity was not observed at any dose tested. Short term and long term dermal ( 1   30 days, 1 6 months, 6 months   lifetime ( Occupational / Residential) None None Based on the intermediate systemic NOAEL of 1,000 mg/ kg/ day in the 21 day dermal toxicity study and the lack of concern for developmental and reproductive effects, the Glyphosate NOF Aug2005 Page 7 of 15 quantification of dermal risks is not required. Short term,

intermediateterm and longterm inhalation ( 1   30 days, 1 6 months, 6 months   lifetime ( Occupational / Residential) None None Based on the systemic toxicity NOEAL of 0.36 mg/ L HDT in the 28 day inhalation toxicity study in rats, and the physical characteristics of the technical ( wetcake), the quantification of inhalation risks is not required. Cancer ( oral, dermal, inhalation) Group E Not applicable No evidence of carcinogenicity * The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.

D. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established ( 40 CFR 180.364) for the residues of ( N ( phosphonomethyl) glycine resulting from the application of the isopropylamine salt of glyphosate, the ammonium salt of glyphosate, and/ or the ethanolamine salt of glyphosate, in or on a variety of food and feed commodities. The petitioner proposes to add a tolerance for Indian mulberry at 0.2 ppm and to increase the tolerance for vegetable legume, group 6, except soybean from the present level of 6.0 ppm to 8.0 ppm. These changes are not expected to increase the dietary burden for livestock, so that the existing tolerances for livestock commodities are sufficient.

Risk assessments were conducted by EPA to assess dietary exposure from glyphosate in food as follows:

i. Acute exposure. Acute dietary risk assessments are performed for a food use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1 day or single exposure. An acute dietary endpoint and dose was not identified for glyphosate. A review of the rat and rabbit developmental studies did not provide a dose or endpoint that could be used to quantify risk to the general population or to females 13   50 years old from a single dose exposure to glyphosate. Therefore, no acute dietary analysis was conducted.

ii. Chronic exposure. In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model ( DEEM FCID ® ) software version 2.03, which incorporates consumption data from the USDA 1994  1998 nationwide Continuing Surveys of Food Intake by Individuals ( CSFII). Consumption data are averaged for the entire U. S. population and within population subgroups for chronic exposure assessment, but are retained as individual consumption events for acute exposure assessment. and accumulated exposure to the chemical for each commodity. The following assumptions were made for the Glyphosate NOF Aug2005 Page 8 of 15 chronic exposure assessments: The chronic dietary exposure analysis was conducted using the chronic polulation adjusted dose ( cPAD) of 1.75 mg/ kg/ day. For chronic dietary exposure and risk assessments, an estimate of the residue level in each food or food form ( i. e., orange or orange juice) on the 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 estimated exposure. Exposure estimates are expressed in milligrams/ kilogram body weight day ( mg/ kg bwt/ day) and as a percent of the cPAD for chronic exposure. This procedure is performed for each population subgroup.

The Tier 1 chronic dietary exposure analysis for glyphosate is an upper bound estimate of chronic dietary exposure. The chronic dietary exposure analysis was performed for the general U. S. population and all population subgroups using DEEM assuming tolerance levels residues and 100% crop treated data for the proposed commodities and all registered uses. For chronic dietary risk, the Agency's LOC is less than 100% cPAD. Dietary exposure estimates for representative population subgroups are presented in Table 4. The results of the chronic analysis indicate that the estimated chronic dietary risk as represented by the percent cPAD is below the Agency's LOC ( 100% cPAD) for the U. S. population and all population subgroups.

Table 3. Summary of Results from Chronic DEEM Analysis of Glyphosate Subgroup Exposure ( mg/ kg/ day) % cPAD U. S. population ( total) 0.035851 2.0 All infants (< 1 year old) 0.059645 3.4 Children ( 1 6 years old) 0.082542 4.7 Children ( 7 12 years old) 0.052334 3.0 Females ( 13 50 years old) 0.028191 1.6 Males ( 13 19 years old) 0.036725 2.1 Males ( 20+ years old) 0.030525 1.7 Seniors ( 55+ years old) 0.023902 1.4 iii. Cancer. The HED Cancer Peer Review Committee classified glyphosate as a Group E chemical, negative for carcinogenicity in humans, based on the absence of evidence of carcinogenicity in male and female rats as well as in male and female mice. There is no evidence of carcinogenic potential.

iv. Anticipated residue and percent crop treated ( PCT) information. The Agency used tolerance levels and 100% PCT data for the proposed commodities and all registered uses.

2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for glyphosate in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of glyphosate. Glyphosate NOF Aug2005 Page 9 of 15 The Agency uses the Generic Estimated Environmental Concentration ( GENEEC) or the Pesticide Root Zone/ Exposure Analysis Modeling System ( PRZM/ EXAMS) to estimate pesticide concentrations in surface water and Screening Concentration in Groundwater ( SCI GROW), which predicts pesticide concentrations in ground water. In general, EPA will use GENEEC ( a Tier 1 model) before using PRZM/ EXAMS ( a Tier 2 model) for a screening level assessment for surface water. The GENEEC model is a subset of the PRZM/ EXAMS model that uses a specific high end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/ EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/ EXAMS model includes a PC area factor as an adjustment to account for the maximum PC coverage within a watershed or drainage basin.

None of these models include consideration of the impact processing ( mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations ( EECs) from these models to quantify drinking water exposure and risk as a percent (%) % RfD or % PAD. Instead, drinking water levels of comparison ( DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and from residential uses. Since DWLOCs address total aggregate exposure to glyphosate, they are further discussed in section E below.

Based on the GENEEC and SCI GROW models, the EECs of glyphosate for acute exposures are estimated to be 21 parts per billion ( ppb) for surface water and 0.0038 ppb for ground water. The EECs for chronic exposures are estimated to be 0.83 ppb for surface water and 0.0038 ppb for ground water, based on glyphosate treatment crops. To estimate the possible concentration of glyphosate in surface water resulting from direct application to water, the Agency assumed application to a water body 6 feet deep. At an application rate of 3.75 lb acid equivalent ( ae)/ A, the estimated concentration is 230 ppb. Because the glyphosate water application estimate is greater than the crop application estimate, 230 ppb is the appropriate value to use in the chronic risk estimate.

3. From non dietary exposure. The term    residential exposure'' is used in this document to refer to non occupational, non dietary exposure ( e. g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

i. Non occupational ( recreational) exposures. Glyphosate is currently registered for use on the following residential non dietary sites: Recreational areas, including parks and golf courses for control of broadleaf weeds and grasses, and lakes and ponds, including reservoirs for control of nuisance aquatic weeds. Based on the registered uses, adult and child golfers are anticipated to have short term post application dermal exposure at golf courses. Swimmers Glyphosate NOF Aug2005 Page 10 of 15 ( adults, children and toddlers) are anticipated to have short term post application dermal and incidental ingestion exposures. However, since the Agency did not select dermal endpoints, no post application dermal assessment is included; only a post application incidental ingestion exposure assessment ( swimmers) is included. Risk estimates for incidental ingestion by swimmers ( adults, children, and toddlers) ranged from 7,600 to 36,000. It should be noted however, that glyphosate is used for non selective weed control on emerged aquatic weeds. In this use pattern, it is unlikely that swimmers would be present in water bodies infested with floating weeds. Thus, the inclusion of the swimmer incidental ingestion exposure assessment is considered by the Agency to be conservative. Table 4 presents a summary of assumptions used to estimate the exposure to adult and toddler child swimmers and the corresponding risk estimates.

Table 4. Assumptions and Risk Estimates for Post Application Swimmer Exposure Assessments for Glyphosate, Isopropylamine salt Exposure Scenario AR 1 ( lb a. e./ A) Maximum Concentratio n in water ( mg/ L) 2 Potential Dose Rate( PDR; oral mg/ kg bw/ day) 3 Shortterm MOE 4 Incidental oral ingestion,

adultfemale 3.75 1.38 0.00493 36,000 Incidental oral, toddler 0.023 7,600 1 Application rate from registered labels for aquatic weed control using glyphosate IPA salt ( ex. label = EPA Reg. No. 524 343; max rate = 7.5 pints/ A containing 4 lb ae glyphosate/ gal. x 1 gal./ 4 pints = 3.75 lb ae/ A. 2 Maximum concentration in water ( top 1 ft.) = 3.75 lb ae/ A x 1A/ 43,560 ft2 x 454,000 mg/ lb x 1/ ft x ft3 / 28.32 L = 1.38 mg/ L. 3 PDR, incidental oral exposure = concentration, Cw ( mg/ L) x ingestion rate, IgR ( L/ hr) x exposure time, ET ( hrs/ d) x 1/ BW ( adultfemale = 60 kg; toddler = 15 kg). 4 MOE = NOAEL/ PDR; short term incidental oral NOAEL = 175 mg/ kg bw/ d; The LOC for adult females and toddlers for short term, incidental oral exposures is MOEs < 100.

The MOEs presented in Table 4 for post application exposure by swimmers to glyphosate in aquatic weed control applications are greater than 100 and do not exceed the Agency's LOC for short term non occupational ( recreational) exposures ( MOEs less than 100).

ii. Residential exposures. Glyphosate is also registered for broadcast and spot treatments on home lawns and gardens by homeowners and by lawn care operators ( LCOs). Based on the registered residential use patterns, there is a potential for short term dermal and inhalation exposures to homeowners who apply products containing glyphosate ( residential handlers). Additionally, based on the results of environmental fate studies, there is also a potential for short Glyphosate NOF Aug2005 Page 11 of 15 and intermediate term post application dermal exposures by adults and toddlers and incidental ingestion exposures by toddlers. However, since the Agency did not select short term or intermediate term dermal or inhalation endpoints, no residential handler or postapplication dermal assessment is included; only a post application toddler assessment for incidental ingestion exposures is included. Risk estimates for toddler post application incidental ingestion exposures ranged from 7,200 to greater than 10 6 . All recreational and residential exposures assessed do not exceed the Agency's level of concern ( MOEs less than 100). Table 5 provides a summary of the short term and intermediate term risk estimates for post application incidental ingestion exposures to toddlers.

Table 5. Summary of Toddler Incidental Ingestion Exposures and Risk Estimates for Residential Use of Glyphosate, Isopropylamine salt 1 Activity AR ( lbs a. e./ A) 2 Residue Estimate 3 PDR ( mg/ kg bw/ d) 4 Short term / Intermediateterm MOE 5 Hand tomouth 1.62 DFR: 0.908 [ mu] g/ cm2 0.0242 7,200 Objectto mouth DFR: 3.63 [ mu] g/ cm2 0.00605 29,000 Soil ingestion Soil residue: 12.2 [ mu] g/ g soil 8.13 x 10  5 10  6 1 Sources: Standard Operating Procedures for Residential Exposure Assessments, Draft, December 17, 1997 and Exposure SAC Policy No. 11, February 22, 2001: Recommended Revisions to the SOPs for Residential Exposure. 2 AR = maximum application rate on Roundup ProDry label ( EPA Reg. No. 524 505) for residential lawn treatment. 3 Residue estimates based on the following protocol from the Residential OPs: Hand to mouth DFR = 1.62 lb ae/ A x 0.05 x ( 4.54 x 10 8 [ mu] g/ lb ae) x ( 2.47 x 10 8 A/ cm2) = 0.908 g/ cm2. Object to mouth DFR = 1.62 lb ae/ A x 0.20 x ( 4.54 x 108 [ mu] g/ lb ae) x ( 2.47 x 10 8 A/ cm2 = 3.63 [ mu] g/ cm2. Soil Residue = 1.62 lb ae/ A x fraction of residue in soil ( 100%)/ cm x ( 4.54 x 108 [ mu] g/ lb ae) x ( 2.47 x 10 8 A/ cm2) x 0.67 cm3/ g = 12.2 mu] g/ g soil. 4 Potential Dose Rate ( PDR; already normalized to body weight of toddler). Hand to mouth PDR = ( 0.908 g/ cm2 x 0.50 x 20 cm2/ event x 20 events/ hr x 10 3 mg/[ mu] g x 2 hrs/ d)/ 15 kg = 0.0242 mg/ kg bwt/ day. Object to mouth PDR = ( 3.63 g/ cm2 x 25 cm2 / d x 10 3 mg/[ mu] g)/ 15 kg = 0.00605 mg/ kg bwt/ day. Soil Ingestion PDR = ( 12.2 [ mu] g/ g soil x 100 mg soil/ d x 10 6 g/[ mu] g)/ 15 kg = 8.13 x 10 5 mg/ kg bwt/ day. 5 MOE = NOAEL/ PDR, where the short term incidental oral NOAEL = 175 mg/ kg/ day the Agency's LOC is for MOEs < 100 ( short term residential).

All MOEs calculated for post application toddler exposures do not exceed the Agency's level of concern for residential exposures ( MOEs less than 100). Glyphosate NOF Aug2005 Page 12 of 15 4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408( b)( 2)( D)( v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider " available information" concerning the cumulative effects of a particular pesticide's residues and    other substances that have a common mechanism of toxicity.''

EPA does not have, at this time, available data to determine whether glyphosate has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, glyphosate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that glyphosate has a common mechanism of toxicitywith other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997).

E. Safety Factor for Infants and Children 1. In general, FFCDA Section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure ( MOE) analysis or through using uncertainty UFs ( safety factors) in calculating a dose level that poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity. The toxicology database for glyphosate is adequate according to the Subdivision F Guideline requirements for a food use chemical. Acceptable developmental toxicity studies in the rat and rabbit are available, as is an acceptable 2 generation reproduction study in the rat. Based on the available data, the Agency determined that there is no evidence of either a quantitative or qualitative increased susceptibility following in utero glyphosate exposure to rats and rabbits, or following prenatal/ postnatal exposure in the 2 generation reproduction study in rats.

3. Conclusion. There is a complete toxicity data base for glyphosate and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The Agency determined that the FQPA safety factor to protect infants and children can be removed ( reduced from 10X to 1X) for all population subgroups and exposure scenarios because: a. The toxicology data base is complete. b. A developmental neurotoxicity study is not required. c. The dietary ( food and drinking water) exposure assessments will not underestimate the potential exposures for infants and children. 2 There is no evidence of increased susceptibility in rats and rabbits to in utero and/ or postnatal exposure to glyphosate.

F. Aggregate Risks and Determination of Safety Glyphosate NOF Aug2005 Page 13 of 15 To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water ( EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure ( i. e., the PAD) is available for exposure through drinking water e. g., allowable chronic water exposure ( mg/ kg/ day) = cPAD  ( average food + residential exposure). This allowable exposure through drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2L/ 70 kg ( adult male), 2L/ 60 kg ( adult female), and 1L/ 10 kg( child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: acute, short term, intermediate term, chronic, and cancer.

When EECs for surface water and groundwater are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water ( when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute aggregate risk ( food + drinking water). The Agency did not identify an appropriate acute dietary endpoint that is the result of a single dose administration of glyphosate. Accordingly, glyphosate is not expected to pose an acute risk.

2. Chronic aggregate risk ( food + drinking water). Using the exposure assumptions described in this unit for chronic exposure ( tolerance level residues and 100% crop treated data for all proposed commodities and registered uses), EPA has concluded that exposure to glyphosate from food will utilize 2.0% of the cPAD for the U. S. population, 3.4% of the cPAD for all infants ( less than 1 year old) and 4.7% of the cPAD for children 1 6 years old. The results of the chronic analysis ( Table 3 in this unit) indicate that the chronic dietary risk estimates for the general U. S. population and all population subgroups associated with the existing and proposed uses of glyphosate do not exceed the Agency's LOC ( less than 100% of the cPAD). Based on the use pattern, chronic residential exposure to residues of glyphosate is not expected. In addition, there is potential for chronic dietary exposure to glyphosate in drinking water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 6 below: Glyphosate NOF Aug2005 Page 14 of 15 Table 6. Aggregate Risk Assessment for Chronic ( Non Cancer) Exposure to Glyphosate Subgroup cPAD ( mg/ kg/ day) Chronic Food Exposure ( mg/ kg/ day) Maximum Chronic Water Exposure 1 Ground Water EEC, ppb Surface Water EEC, ppb Chronic DWLOC 2 U. S. population ( total) 1.75 0.035851 1.714149 0.0038 230 60000 All infants (< 1 year old) 1.75 0.059645 1.690355 0.0038 230 17000 Children ( 1 6 years old) 1.75 0.082542 1.667458 0.0038 230 17000 Children ( 7 12 years old) 1.75 0.052334 1.697666 0.0038 230 17000 Females ( 13 50 years old) 1.75 0.028191 1.721809 0.0038 230 60000 Males ( 13 19 years old) 1.75 0.036725 1.713275 0.0038 230 60000 Males ( 20+ years old) 1.75 0.030525 1.719475 0.0038 230 60000 Seniors ( 55+ years old) 1.75 0.023902 1.726098 0.0038 230 60000 1 Maximum chronic water exposure ( mg/ kg/ day) = cPAD ( mg/ kg/ day)   chronic food exposure from DEEMTM ( mg/ kg/ day). 2 The chronic DWLOCs were calculated as follows: DWLOC ([ mu] g/ L) = Maximum water exposure ( mg/ kg/ day) x body weight ( kg)/ consumption L/ day) x 0.001 mg/[ mu] g.

3. Short and intermediate term aggregate risk ( food + residential + water). In aggregating short term/ intermediate term risk, HED considered background chronic dietary exposure ( food + water) and shortterm intermediate term incidental oral exposures ( see Tables 6 and 7). Because the incidental oral ingestion exposure estimates for toddlers from residential turf exposures ( Table 7) exceeded the incidental oral exposure estimates from post application swimmer exposures ( Table 6), the Agency conducted this risk assessment using exposure estimates from just the worst case situation. No attempt was made to combine exposures from the swimmer and residential turf scenarios due to the low probability of both occurring.

The total short term/ intermediate term food and residential aggregate MOEs are 1,800 2,300. As these MOEs are greater than 100, the shortterm intermediate term aggregate risk does not exceed the Agency's LOC. For surface water and ground water, the EECs of glyphosate are less than the DWLOCs for glyphosate in drinking water as a contribution to shortterm intermediate term aggregate exposure. Therefore, the Agency concludes with reasonable certainty that residues of glyphosate in drinking water do not contribute significantly to the short Glyphosate NOF Aug2005 Page 15 of 15 term/ intermediate term aggregate human health risk at the present time. Table 8 summarizes the short term/ intermediate term aggregate exposure to glyphosate residues.

Table 8. Short Term/ Intermediate Term Aggregate Risk and DWLOC Calculations for Exposure to Glyphosate Residues Short Term/ Intermediate Term Exposure Scenario Population Aggregate MOE ( food+ residential) 1 Aggregate Level of Concern ( LOC) or Target MOE 2 Surface Water EEC 3 ( ppb) Ground Water EEC 3 ( ppb) Short Term/ Intermediate Term DWLOC 4 ( ppb)

All Infants (< 1 year old) 2300 100 230 0.0038 17,000 Children ( 1 6 years old) 1600 100 230 0.0038 17,000 Children ( 7 12 years old) 2200 100 230 0.0038 17,000 1 Aggregate MOE = NOAEL/( Average food exposure + Residential exposure). 2 Basis for the target MOE: interspecies and intraspecies uncertainty factors totaling 100. 3 The glyphosate use producing the highest level was used. 4 DWLOC ([ mu] g/ L or ppb) = maximum water exposure ( mg/ kg/ day) x bwt ( kg) / water consumption ( L) x 10 3 mg/[ mu] g ( 10 kg bwt assumed).

4. Aggregate cancer risk for U. S. population. Glyphosate has been classified as a Group E chemical, with no evidence of carcinogenicity for humans in two acceptable animal studies. Glyphosate is not expected to pose a cancer risk to humans.

5. Determination of safety. Based on these risk assessments, Monsanto concludes that there is reasonable certainty that no harm will result from the aggregate exposure to glyphosate residues.

G. International Residue Limits Several maximum residue limits ( MRLs) for glyphosate have been established by CODEX in or on various commodities. These limits are based on the residue definition of glyphosate per se. Codex has not established an MRL for glyphosate residues in or on Indian mustard, but has established MRLs for peas ( dry) at 5 ppm and for beans ( dry) at 2 ppm. Because of the different agronomic practices and the use of a crop group tolerance in the US, the present proposal for " vegetables, legume group 6 except soybeans" cannot be harmonized with Codex.