[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Rules and Regulations]
[Pages 25545-25548]
[FR Doc No: 2011-10929]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0097]
RIN 1625-AA00

Safety Zone; Blue Crab Festival Fireworks Display, Little River,
Little River, SC

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
waters of Little River in Little River, South Carolina during the Blue
Crab Festival Fireworks Display on Friday,

May 13, 2011. The safety zone is necessary to protect the public from
the hazards associated with launching fireworks over the navigable
waters of the United States. Persons and vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
safety zone unless authorized by the Captain of the Port Charleston or
a designated representative.

DATES: This rule is effective from 9 p.m. until 10:30 p.m. on May 13,
2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-0097 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-0097 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary final rule, call or e-mail Lieutenant Julie Blanchfield,
Sector Charleston Waterways Management Division, Coast Guard; telephone
843-740-3184, e-mail<EMAIL_ADDRESS>If you have
questions on viewing the docket, call Renee V. Wright, Program Manager,
Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the Coast Guard did not receive
notice of the Blue Crab Festival Fireworks Display with sufficient time
to publish an NPRM and to receive public comments prior to the event.
Any delay in the effective date of this rule would be contrary to the
public interest because immediate action is needed to minimize the
potential danger to the public during the fireworks display.
    For the same reason discussed above, under 5 U.S.C. 553(d)(3) the
Coast Guard finds that good cause exists for making this rule effective
less than 30 days after publication in the Federal Register. The Coast
Guard will issue a Local Notice to Mariners and Broadcast Notice to
Mariners to advise mariners of the restriction.

Background and Purpose

    On May 13, 2011, The Little River Blue Crab Festival Inc., in
partnership with Zambelli Fireworks Manufacturing Co., will be
conducting a fireworks display in Little River, South Carolina as part
of the 30th Annual Blue Crab Festival. The fireworks will explode over
the waters of Little River. The fireworks display is scheduled to
commence at 9:30 p.m. and conclude at 9:45 p.m. This temporary safety
zone is necessary to protect the public from the hazards associated
with the launching of fireworks over navigable waters of the United
States.

Discussion of Rule

    The safety zone encompasses certain waters of Little River in
Little River, South Carolina. The safety zone will be enforced from 9
p.m. until 10:30 p.m. on May 13, 2011. The safety zone will be enforced
from 9 p.m., 30 minutes prior to the scheduled commencement of the
fireworks display at approximately 9:30 p.m., to ensure the safety zone
is clear of persons and vessels. Enforcement of the safety zone will
cease at 10:30 p.m., 45 minutes after the scheduled conclusion of the
fireworks display, to account for possible delays.
    Persons and vessels are prohibited from entering, transiting
through, anchoring in, or remaining within the safety zone unless
authorized by the Captain of the Port Charleston or a designated
representative. Persons and vessels desiring to enter, transit through,
anchor in, or remain within the safety zone may contact the Captain of
the Port Charleston via telephone at<PHONE_NUMBER>, or a designated
representative via VHF radio on channel 16, to seek authorization. The
Coast Guard will provide notice of the safety zone by Local Notice to
Mariners, Broadcast Notice to Mariners, and on-scene designated
representatives.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Executive Order 12866 and Executive Order 13563

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, and does not require an
assessment of potential costs and benefits under section 6(a)(3) of
that Order. The Office of Management and Budget has not reviewed it
under that Order.
    The economic impact of this rule is not significant for the
following reasons: (1) The rule will be enforced for only one and a
half hours; (2) vessel traffic in the area is expected to be minimal
during the enforcement period; (3) although persons and vessels will
not be able to enter, transit through, anchor in, or remain within the
safety zone without authorization from the Captain of the Port
Charleston or a designated representative, they may operate in the
surrounding area during the enforcement period; (4) persons and vessels
may still enter, transit through, anchor in, or remain within the
safety zone if authorized by the Captain of the Port Charleston or a
designated representative; and (5) the Coast Guard will provide advance
notification of the safety zone to the local maritime community by
Local Notice to Mariners and Broadcast Notice to Mariners.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule may affect the following entities, some of which
may be small entities: The owners or operators of vessels intending to
enter, transit through, anchor in, or remain within that portion of
Little River encompassed within the safety zone from 9 p.m. until 10:30
p.m. on May 13, 2011. For the reasons discussed in the Executive Order
12866 and Executive Order 13563 section above, this rule will not have
a significant economic impact on a substantial number of small
entities.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction. This rule involves establishing a
temporary safety zone to protect the public on the waters of Little
River that will be enforced for a total of one and a half hours. An
environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add a temporary Sec.  165.T07-0097 to read as follows:

Sec.  165.T07-0097  Safety Zone; Blue Crab Festival Fireworks Display,
Little River, Little River, SC.

    (a) Regulated Area. The following regulated area is a safety zone:
All waters of Little River encompassed within a 100 yard radius of
position 33[deg]52'08'' N, 78[deg]36'42'' W. All coordinates are North
American Datum.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the

Captain of the Port Charleston in the enforcement of the regulated
area.
    (c) Regulations.
    (1) All persons and vessels are prohibited from entering,
transiting through, anchoring in, or remaining within the regulated
area unless authorized by the Captain of the Port Charleston or a
designated representative.
    (2) Persons and vessels desiring to enter, transit through, anchor
in, or remain within the regulated area may contact the Captain of the
Port Charleston by telephone at<PHONE_NUMBER>, or a designated
representative via VHF radio on channel 16, to seek authorization. If
authorization to enter, transit through, anchor in, or remain within
the regulated area is granted by the Captain of the Port Charleston or
a designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port Charleston or a designated representative.
    (3) The Coast Guard will provide notice of the regulated area by
Local Notice to Mariners, Broadcast notice to mariners, and on-scene
designated representatives.
    (d) Effective Date. This rule is effective from 9 p.m. until 10:30
p.m. on May 13, 2011.

    Dated: April 26, 2011.
Michael F. White Jr.,
Captain, U.S. Coast Guard, Captain of the Port Charleston.
[FR Doc. 2011-10929 Filed 5-4-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: June 11, 2008 (Volume 73, Number 113)]
[Notices]
[Page 33128-33131]
[DOCID:fr11jn08-106]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57913; File No. SR-CBOE-2008-31]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing of Proposed Rule Change to List and
Trade CBOE S&P 500 Three-Month Realized Variance Options and CBOE S&P
500 Three-Month Realized Volatility Options

June 3, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 23, 2008, the Chicago Board Options Exchange, Incorporated
(``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been substantially
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend certain of its rules, including
Rules 5.5, 24.1, and 24.9, to provide for the listing and trading of
options that overlie two statistical measurements of market
variability: Realized variance and realized volatility of the S&P 500
Composite Stock Price Index (``S&P 500 Index''). CBOE S&P 500 Three-
Month Realized Variance options and CBOE S&P 500 Three-Month Realized
Volatility options would be cash-settled and have European-style
exercise. The text of the rule proposal and proposed contract
specifications for CBOE S&P 500 Three-Month Realized Variance options
are available on the Exchange's Web site (http://www.cboe.org/legal),
at the Exchange's Office of the Secretary and at the Commission.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to permit the Exchange
to list and trade cash-settled options having European-style exercise
on two statistical measurements of market variability: Realized
variance and realized volatility of the S&P 500 Index. These
statistical measurements are attributes of and based on a broad-based
security index (i.e., S&P 500 Index). Three-month realized variance is
a measure of the historical variability of the S&P 500 Index, based on
actual prices that have been reported, or ``realized,'' historically
looking back over a three-month period. The calculation uses daily
returns for the three-month period relative to an average (mean) daily
price return of zero. Three-month realized volatility is the square
root of three-month realized variance. The Exchange also proposes to
make technical changes to some of the rules that would be amended in
order to list and trade realized variance and realized volatility
options.
    Currently, the Exchange lists and trades options on the 30-day
implied volatility of the S&P 500 Index (CBOE Volatility Index
(``VIX'') options).\3\ With the introduction of realized variance and
realized volatility options, market participants would be able to trade
options that settle to the actual or realized volatility of the S&P 500
Index that has accrued over a three-month time period. Different from
VIX options, realized variance and realized volatility options would
allow market participants to take a position on what they anticipate
the actual volatility of the S&P 500 Index would be at expiration. In
addition, the Exchange also notes that realized variance contracts are
a popular and successful product in the over-the-counter (``OTC'')
market. By providing a listed and standardized market for realized
variance and realized volatility options, the Exchange seeks to attract
investors who desire to trade options on realized variance and realized
volatility but at the same time prefer the certainty and safeguards of
a regulated and standardized marketplace.
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    \3\ The Exchange also calculates the CBOE S&P 500 Three-Month
Volatility Index (``VXV''), which measures implied volatility, but
the Exchange currently does not list VXV options.
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Calculation of Realized Variance and Realized Volatility
    The formula for three-month realized variance and three-month
realized volatility uses continuously compounded daily returns for a
three-month period assuming a mean daily price return of zero. The
calculated realized variance is then annualized assuming 252 business
days per year.\4\ The exercise-settlement value for CBOE S&P 500 Three-
Month Realized Variance options is 10,000 times the three-month
realized variance of the S&P 500 Index, and the exercise-settlement
value for CBOE S&P 500 Three-Month Realized Volatility options is 100
times the three-month realized volatility of the S&P 500 Index, both of
which are calculated using the following standardized formula:
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    \4\ The annualization factor for realized volatility is the
square root of 252.
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REALIZED VARIANCE AND REALIZED VOLATILITY FORMULAS:

[GRAPHIC] [TIFF OMITTED] TN11JN08.000

Where:

    Ri = ln (Pi+1/Pi)--Daily return of the S&P
500 Index from Pi to Pi+1.
Pi+1 = The final value of the S&P 500 Index used to
calculate the daily return.
Pi = The initial value of the S&P 500 Index used to
calculate the daily return.
Ne = Number of expected S&P 500 Index values needed to calculate
daily returns during the three-month period. The total number of
daily returns expected during the three-month period is Ne-1.
Na = The actual number of S&P 500 Index values used to calculate
daily returns during the three-month period. Generally, the actual
number of S&P 500 Index values will equal the expected number of S&P
500 Index values (represented by Ne). However, if one or more
``market disruption events'' occurs during the three-month period,
the actual number of S&P 500 Index values will be less than the
expected number of S&P 500 Index values by an amount equal to the
number of market disruption events that occurred during the three-
month period. The total number of actual daily returns during the
three-month period is Na-1.

    For purposes of calculating the respective exercise-settlement
value to which the options would settle, realized variance and realized
volatility are calculated from a series of values of the S&P 500 Index
beginning with the Special Opening Quotation (``SOQ'') of the S&P 500
Index on the first day of the three-month period, and ending with the
S&P 500 Index SOQ on the last day of the three-month period.\5\ All
other values in the series are closing values of the S&P 500 Index.
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    \5\ The SOQ is calculated per normal index calculation
procedures and uses the opening (first) reported sales price in the
primary market of each component stock in the index on the last
business day (usually a Friday) before the expiration date. If a
stock in the index does not open on the day on which the exercise-
settlement value is determined, the last reported sales price in the
primary market is used to calculate the exercise-settlement value.
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    For example, the final exercise-settlement value to which a CBOE
S&P 500 Three-Month Realized Variance option contract expiring on
Friday, September 19, 2008 would settle would be calculated using the
S&P 500 Index SOQ on Friday, June 20, 2008, the closing prices of the
S&P 500 Index from Monday, June 23, 2008 through Thursday, September
18, 2008 and the S&P 500 Index SOQ on Friday, September 19, 2008.
    As described above, three-month realized variance and three-month
realized volatility would be calculated using actual daily values of
the S&P 500 Index, which is a broad-based security index. By extension,
products based on statistical measurements that are derived from S&P
500 Index values should similarly be treated as products based directly
on S&P 500 Index values. For purposes of CBOE's rules, the indicative
values for three-month realized variance and three-month realized
volatility shall be treated as indexes.
    Currently, CBOE calculates indicative values for implied and
realized variance, and publishes those values daily after the close of
trading. The CBOE S&P 500 Implied Variance indicator (``IUG'') is a
measure of the market's expectation of future variance of the S&P 500
Index that is implied by the daily settlement price of the front-month
CBOE S&P 500 Three-Month Variance futures contract.\6\ The CBOE S&P 500
Realized Variance indicator (``RUG'') is a measure of the realized
variance of the S&P 500 Index from the beginning of the three-month
period to the current date. IUG and RUG are disseminated through the
Options Price Reporting Authority (``OPRA'') and are publicly available
through most price quote vendors.\7\
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    \6\ CBOE Futures Exchange, LLC (``CFE'') currently lists CBOE
S&P 500 Three-Month Realized Variance future contracts, which
commenced trading on May 18, 2004.
    \7\ These values can be accessed by typing in the ticker symbol
(IUG or RUG) at the following Web page: http://cfe.cboe.com/
DelayedQuote/SSFQuote.aspx.
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Options Trading
    The exercise-settlement value for CBOE S&P 500 Three-Month Realized
Variance options would be 10,000 times the three-month realized
variance of the S&P 500 Index. Realized variance would be quoted in
variance points and fractions and one point would equal $50. The
minimum tick size for all series would be 0.10 point ($5.00) and the
minimum strike price interval would be $5.00.\8\
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    \8\ See Rules 5.5 and 24.9.
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    The exercise-settlement value for CBOE S&P 500 Three-Month Realized
Volatility options would be 100 times the three-month realized
volatility of the S&P 500 Index. Realized volatility would be quoted in
volatility points and fractions and one point would equal $100. The
minimum tick size for series trading below 3.00 would be 0.05 point
($5.00) and the minimum tick for series trading at and above 3.00 would
be 0.10 point ($10.00). The minimum strike price interval would be
$1.00.
    The Exchange proposes to list series at $1 or greater strike price
intervals on CBOE S&P 500 Three-Month Realized Volatility options. The
Exchange believes that $1 strike price intervals would provide
investors with greater flexibility by allowing them to establish
positions that are better tailored to meet their investment objectives.
CBOE believes that traders would likely use the related CBOE S&P 500
Three-Month Variance futures contract price as a proxy for the
``current index level.'' This is because the futures contract price
reflects: (i) The realized variance of the S&P 500 Index experienced to
date; and (ii) the market's expectation of the future variance of the
S&P 500 Index at expiration of the respective contract. CBOE believes
that using futures prices is an accurate and transparent method for
determining the ``current index level'' used to center the range in
which $1 or greater strikes in CBOE S&P 500 Three-Month Realized
Volatility options would be listed.\9\
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    \9\ The Commission has approved the listing of options and LEAPS
in $1 strike intervals, and the use of futures prices in setting
those strike intervals, for all other implied volatility products
approved for listing and trading on the Exchange. See Rule
24.9.01(e)(ii). See also Securities Exchange Act Release Nos. 54192
(July 21, 2006), 71 FR 43251 (July 31, 2006) (SR-CBOE-2006-27) ($1
strikes for VIX options); 55425 (March 8, 2007), 72 FR 12238 (March
15, 2007) (SR-CBOE-2006-73) ($1 strikes for RVX options); 56813
(November 19, 2007), 72 FR 66211 (November 27, 2007) (SR-CBOE-2007-
52) ($1 strikes for VXD and VXN options and $1 strikes for RVX, VIX,
VXD and VXN LEAPS).
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    Initially, the Exchange would list at least two strike prices above
and two strike prices below the square root of the related CBOE S&P 500
Three-Month Variance futures contract price at or about the time a
series is opened for trading on the Exchange. As part of this

initial listing, the Exchange would list strike prices that are within
5 points from the square root of the related CBOE S&P 500 Three-Month
Variance futures contract price on the preceding day.
    As for additional series, the Exchange would be permitted to add
additional series when the Exchange deems it necessary to maintain an
orderly market, to meet customer demand or when the square root of the
related CBOE S&P 500 Three-Month Variance futures contract price moves
substantially from the initial exercise price or prices. To the extent
that any additional strike prices are listed by the Exchange, such
additional strike prices shall be within thirty percent (30%) above or
below the square root of the related CBOE S&P 500 Three-Month Variance
futures contract price. The Exchange would also be permitted to open
additional strike prices that are more than 30% above or below the
square root of the related CBOE S&P 500 Three-Month Variance futures
contract price, provided that demonstrated customer interest exists for
such series, as expressed by institutional, corporate or individual
customers or their brokers. Market-makers trading for their own account
would not be considered when determining customer interest. In addition
to the initial listed series, the Exchange proposes to list up to sixty
(60) additional series per expiration month for each series in CBOE S&P
500 Three-Month Realized Volatility options. Further, LEAPS on CBOE S&P
500 Three-Month Realized Volatility options would not be listed at
intervals less than $1.
    The Exchange also proposes to set forth a delisting policy with
respect to CBOE S&P 500 Three-Month Realized Volatility options.
Specifically, the Exchange would, on a monthly basis, review series
that are outside a range of five (5) strikes above and five (5) strikes
below the square root of the related CBOE S&P 500 Three-Month Variance
futures contract price and delist series with no open interest in both
the put and the call series having a: (i) Strike higher than the
highest strike price with open interest in the put and/or call series
for a given expiration month; and (ii) strike lower than the lowest
strike price with open interest in the put and/or call series for a
given expiration month.
    Notwithstanding the proposed delisting policy, customer requests to
add strikes and/or maintain strikes in CBOE S&P 500 Three-Month
Realized Volatility option series eligible for delisting shall be
granted.
    The Exchange also proposes to add new Interpretation and Policy .11
to Rule 5.5, Series of Option Contracts Open for Trading, which would
be an internal cross reference stating that the intervals between
strike prices for CBOE S&P 500 Three-Month Realized Volatility options
series would be determined in accordance with proposed new
Interpretation and Policy .01(g) to Rule 24.9.
Exercise and Settlement
    The proposed options would expire on the Saturday following the
third Friday of the expiring month. Trading in the expiring contract
month would normally cease at 3:15 p.m. Chicago time on the business
day preceding the last day of trading (ordinarily the Thursday before
expiration Saturday, unless there is an intervening holiday). When the
last trading day is moved because of an Exchange holiday (such as when
CBOE is closed on the Friday before expiration), the last trading day
for expiring options would be Thursday. As described above, the
exercise-settlement value would be calculated from a series of values
of the S&P 500 Index beginning with the SOQ of the S&P 500 Index on the
first day of the three-month period, and ending with the S&P 500 Index
SOQ on the last day of the three-month period. All other values in the
series are closing values of the S&P 500 Index.
    The exercise-settlement amount is equal to the difference between
the exercise-settlement value and the exercise price of the option
multiplied by $50 for CBOE S&P 500 Three-Month Realized Variance
options and multiplied by $100 for CBOE S&P 500 Three-Month Realized
Volatility options.
Surveillance
    The Exchange would use the same surveillance procedures currently
utilized for each of the Exchange's other index options to monitor
trading in CBOE S&P 500 Three-Month Realized Variance options and CBOE
S&P 500 Three-Month Realized Volatility options. The Exchange
represents that these surveillance procedures are adequate to monitor
trading in options on these option products. For surveillance purposes,
the Exchange would have complete access to information regarding
trading activity in the pertinent underlying securities (i.e., S&P 500
Index component securities).
Position Limits
    The Exchange is not proposing to establish any position limits for
CBOE S&P 500 Three-Month Realized Variance options and CBOE S&P 500
Three-Month Realized Volatility options. Because realized variance and
realized volatility are calculated using values of the S&P 500 Index,
the Exchange believes that the position and exercise limits for these
new products should be the same as those for broad-based index options
(e.g., SPX, for which there are no position limits). CBOE S&P 500
Three-Month Realized Variance options and CBOE S&P 500 Three-Month
Realized Volatility options would be subject to the same reporting and
other requirements triggered for other options dealt in on the
Exchange.\10\
---------------------------------------------------------------------------

    \10\ See Rule 4.13, Reports Related to Position Limits.
---------------------------------------------------------------------------

Exchange Rules Applicable
    As stated above, for purposes of CBOE's rules, the indicative
values for three-month realized variance and three-month realized
volatility shall be treated as indexes. Except as modified by this
proposal, the rules in Chapters I through XIX, XXIV, XXIVA, and XXIVB
would equally apply to CBOE S&P 500 Three-Month Realized Variance
options and CBOE S&P 500 Three-Month Realized Volatility options.
    CBOE S&P 500 Three-Month Realized Variance options and CBOE S&P 500
Three-Month Realized Volatility options would be margined as ``broad-
based index'' options, and under CBOE rules, especially, Rule
12.3(c)(5)(A), the margin requirement for a short put or call shall be
100% of the current market value of the contract plus up to 15% of the
respective underlying indicative value. Additional margin may be
required pursuant to Exchange Rule 12.10.
    The Exchange proposes that CBOE S&P 500 Three-Month Realized
Variance options and CBOE S&P 500 Three-Month Realized Volatility
options be eligible for trading as Flexible Exchange Options as
provided for in Chapters XXIVA (Flexible Exchange Options) and XXIVB
(FLEX Hybrid Trading System).
Capacity
    CBOE has analyzed its capacity and represents that it believes the
Exchange and the Options Price Reporting Authority have the necessary
systems capacity to handle the additional traffic associated with the
listing of new series that would result from the introduction of CBOE
S&P 500 Three-Month Realized Variance options and CBOE S&P 500 Three-
Month Realized Volatility options.

Technical Changes
    The Exchange proposes to make technical changes to Rules 24.4.03,
24.4.04, and 24.5, Exercise Limits by adding ``VIX, VXN and VXD'' to
the rule text.\11\ The Exchange proposes to make technical changes to
Rules 24A.7(b), 24A.8(a), 24B.7(b), and 24B.8(a), by adding the
parenthetical phrase, ``including reduced-value option contracts'' to
the rule text. These FLEX rules already contemplate reduced-value
option contracts, and the proposed changes are consistent with the
treatment of non-FLEX reduced-value option contracts.\12\
---------------------------------------------------------------------------

    \11\ The Exchange inadvertently neglected to request the
Commission's approval to add ``VIX, VXN and VXD'' to the respective
rule text when the position limits for these products were
eliminated. See Securities Exchange Act Release No. 54019 (June 20,
2006), 71 FR 36569 (June 27, 2006) (SR-CBOE-2006-55).
    \12\ See Securities Exchange Act Release No. 56350 (September 4,
2007), 72 FR 51878 (September 11, 2007) (SR-CBOE-2007-79).
---------------------------------------------------------------------------

2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \13\ of
the Act in general and furthers the objectives of Section 6(b)(5) \14\
in particular in that it would permit trading in options based on the
index pursuant to rules designed to prevent fraudulent and manipulative
acts and practices and to promote just and equitable principles of
trade, and thereby would provide investors with the ability to invest
in options that provide statistical measurements of market variability.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    CBOE believes that the proposed rule change does not impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

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

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    A. By order approve such proposed rule change, or
    B. institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-CBOE-2008-31 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2008-31. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2008-31 and should be
submitted on or before July 2, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-13019 Filed 6-10-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 18 (Thursday, January 27, 2011)]
[Notices]
[Pages 4928-4929]
[FR Doc No: 2011-1807]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2007-0008]

National Advisory Council

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Committee Management; Request for Applicants for Appointment to
the National Advisory Council.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) is requesting
individuals who are interested in serving on the National Advisory
Council (NAC) to apply for appointment. As provided for in the
Department of Homeland Security Appropriations Act of 2007, the
Secretary of Homeland Security established the NAC to ensure effective
and ongoing coordination of Federal

preparedness, protection, response, recovery, and mitigation for
natural disasters, acts of terrorism, and other man-made disasters.

DATES: Applications for membership should reach FEMA at the address
below beginning Friday, February 4, 2011 and before 5 p.m. EST, on
Friday, March 4, 2011.

ADDRESSES: Applications for membership should be submitted by:
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: The National Advisory Council Office, Federal
Emergency Management Agency (Room 832), 500 C Street, SW., Washington,
DC 20472-3100.

FOR FURTHER INFORMATION CONTACT: Designated Federal Officer, Alyson
Price, The National Advisory Council Office, Federal Emergency
Management Agency (Room 832), 500 C Street, SW., Washington, DC 20472-
3100; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; and e-mail<EMAIL_ADDRESS>For more information on the NAC, please visit the NAC Web
site at http://www.fema.gov/about/nac. FEMA's Ethics Office may be
contacted at telephone<PHONE_NUMBER> or e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The National Advisory Council (NAC) is an
advisory committee established in accordance with the provisions of the
Federal Advisory Committee Act (FACA), 5 U.S.C. App. 1, et seq. (Pub.
L. 92-463). The Secretary of Homeland Security established the NAC to
ensure effective and ongoing coordination of Federal preparedness,
protection, response, recovery, and mitigation for natural disasters,
acts of terrorism, and other man-made disasters (6 U.S.C. 318).
    The NAC consists of 35 members, all of whom are experts and leaders
in their respective fields. Approximately one-third of the membership
was appointed for a 3-year term expiring on June 15, 2011. Accordingly,
the following discipline areas will have a position open for
applications and nominations: Emergency Management, Emergency Response,
Health Scientist, Standard Settings, Infrastructure Protection,
Communications, Disabilities, Local Non-Elected Official, Tribal
Elected Official, and three appointments which will be selected at the
discretion of the FEMA Administrator. In addition, FEMA seeks
applications to fill the remaining term for the Local Elected Official
position whose term ends on June 15, 2012 and for the State Non-Elected
Official position and an Administrator's Selection position which both
end on June 15, 2013.
    Appointees may be designated as Special Government Employees (SGE)
as defined in section 202(a) of title 18, United States Code.
Candidates selected for appointment as SGEs are required to complete a
Confidential Financial Disclosure Form (Office of Government Ethics
(OGE) Form 450). OGE Form 450 or the information contained therein may
not be released to the public except under an order issued by a Federal
court or as otherwise provided under the Privacy Act (5 U.S.C. 552a).
Applicants can obtain this form by going to the Web site of the Office
of Government Ethics (http://www.oge.gov), contacting the NAC Office,
or by contacting the FEMA Ethics Office. Contact information is
provided in the FOR FURTHER INFORMATION CONTACT section of this notice.
    The NAC assists FEMA in carrying out its missions by providing
advice and recommendations to the FEMA Administrator on the development
and revision of the national preparedness goal, the national
preparedness guidelines, the National Incident Management System, the
National Response Framework, National Exercise Program, and other
related plans and strategies. The members of the NAC are appointed by
the Administrator of FEMA and are composed of Federal, State, local,
Tribal, and private-sector leaders and subject matter experts in law
enforcement, fire, emergency medical services, hospital, public works,
emergency management, State and local governments, public health,
emergency response, standard settings and accrediting organizations,
representatives of individuals with disabilities and other special
needs, infrastructure protection, cyber security, communications, and
homeland security communities.
    Qualified individuals interested in serving on the NAC are invited
to apply for appointment by submitting a resume or Curriculum Vitae
(CV) to the NAC Office as listed in the ADDRESSES section of this
notice. Letters of recommendation may also be provided, but are not
required. Please ensure the submission includes the following
information: The applicant's full name, home and business phone
numbers, preferred e-mail address, home and business mailing addresses,
current position title & organization, and the discipline area of
interest (i.e., Emergency Management). Current NAC members whose terms
are ending should notify the NAC Office of their interest in
reappointment in lieu of submitting a new application, and should
provide an updated resume and/or CV and letters of recommendation for
consideration, if desired. The NAC meets in a plenary session
approximately once per quarter. The NAC also holds at least one yearly
teleconference meeting with public call-in lines. Members serve without
compensation from the Federal Government; however, consistent with the
charter, they do receive travel reimbursement and per diem under
applicable Federal travel regulations. In support of the policy of the
Department of Homeland Security on gender and ethnic diversity,
qualified women and minorities are encouraged to apply for membership.
Registered lobbyists, current FEMA employees, Disaster Assistance
Employees, FEMA Contractors, and potential FEMA Contractors will not be
considered for NAC Membership.

    Dated: January 21, 2011.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-1807 Filed 1-26-11; 8:45 am]
BILLING CODE 9111-48-P


Amended Notice of Filing: IR-4 PP#7E7258

<EPA Registration Division contact: Susan Stanton,<PHONE_NUMBER>>

<Interregional Research Project Number 4 (IR-4) PP#7E7258>

<	EPA has received an amended pesticide petition (PP#7E7258) from
Interregional Research Project Number 4 (IR-4), 500 College Rd., East,
Suite 201 W, Princeton, NJ  08540 proposing, pursuant to section 408(d)
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d),
to amend 40 CFR part 180.476 by establishing tolerances  for residues of
triflumizole, 1-[1-((4-chloro-2-(trifluoromethyl)
phenyl)imino)-2propoxyethyl]-1H-imidazole, and its metabolites
containing the 4-chloro-2-trifluoromethylaniline moiety, in or on the
raw agricultural commodities leafy greens subgroup 4A, except spinach
and cilantro at 35 ppm parts per million (ppm); turnip, greens at 40
ppm; Swiss chard at 18 ppm; Pineapple at 4.0 ppm; Papaya; Sapote, black;
Canistel; Sapote, mamey; Mango; Sapodilla; and Star apple at 2.5 ppm;
and Hop,dried cones at 50.0 ppm.  EPA has determined that the petition
contains data or information regarding the elements set forth in section
408 (d)(2) of the FDDCA; however, EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
supports granting of the petition. Additional data may be needed before
EPA rules on the petition.>

<A. Residue Chemistry>

<	1. Plant metabolism. In crops, the metabolism of [14C]-Phenyl]
triflumizole was investigated in cucumber, pears, grapes and apples. The
major metabolites were:
N-(4chloro-2trifluoromethylphenyl)-n-propoxyacetamidine  (FM-6-1),
N-(4-chloro-2-trifluoromethylphenyl)-n-propoxyacetanilide  (FD-1-1) and
the free or conjugated products of
N-(4-chloro-2-trifluoromethylphenyl)-hydroxyacetamidine (the
0-dealkylation product of FM-6-1),
N-(4-chloro-2-trifluoromethylphenyl)-hydroxyacetanilide (FD-2-1) and the
triflumizole aniline (FA-1-1).

	2. Animal metabolism. In livestock, oral administration of
[14C]-triflumizole was conducted twice daily for 5 days at 14 mg/kg/day
(equivalent to 280 ppm in feed for the cow) and 144 mg/kg/day
(equivalent to 50 ppm in feed for chicken). On the sixth day the animals
were sacrificed and meat, milk and egg samples were analyzed.  Cow’s
liver, kidney, fat and muscle contained 11.26, 3.36, 0.66, and 0.30 ppm
of [14C]-triflumizole equivalent, respectively. Residues in milk reached
a plateau of about 0.7 ppm after 24 hours. Chicken liver, kidney, fat,
and muscle contained 1.10, 0.74, 0.17 and 0.05 ppm of [14C]-triflumizole
equivalent, respectively.  Residues in eggs reach a maximum of 0.30 ppm
level. Metabolites identified in these tissues were mainly triflumizole
aniline (FA-1-1) and the sulfate/glucuronide conjugates of the 6-hydroxy
derivative of triflumizole aniline (FA-1-5). The latter was the major
metabolite in milk. Unchanged triflumizole was present in trace amounts
in the whole egg.>

<	3. Analytical method. The analytical method is suitable for analyzing
crops for residues of triflumizole and its aniline containing
metabolites at the proposed tolerance levels. The analytical method has
been independently validated. Residue levels of triflumizole are
converted to FA-1-1 by acidic and alkaline reflux, followed by
distillation. Residues are then extracted and subjected to SPE
purification. Detection and quantitation are conducted by gas
chromatograph equipped with nitrogen phosphorus detector, electron
capture detector or mass spectrometry detection. The limit of
quantitation of the method has been determined in the range of 0.01 ppm
to 0.05 ppm for the combined residues of triflumizole and FA-1-1. The
enforcement methodology has been submitted to the Food & Drug
Administration for publication in the Pesticide Analytical Manual, Vol.
II (PAM II).>

<	4. Magnitude of residues. Section 3 registrations for triflumizole is
currently exist for several commodities (e.g., apple, cherry, filbert,
grape, pear, strawberry, cucurbits, and meat, milk, poultry and eggs)
and feed items. The proposed group tolerance for leafy brassica
vegetables (subgroup 5B) at 20 ppm is pending (PP#7E7183). The subject
of the August 23, 2006 Federal Register notice regarding triflumizole
was the establishment and/or extension of emergency exemption tolerances
on several crops in Texas (i.e., parsley leaves, dandelion leaves, Swiss
chard, collard, kale, kohlrabi, mustard greens, Chinese napa cabbage,
broccoli, coriander leaves and turnips greens). Many of these crops are
in subgroup 4A leafy greens and 5A head and stem brassica, so the
purpose of this dietary exposure assessment is to expand the uses of
triflumizole to all crops in subgroup 4A , 5A and 5B to Swiss chard,
hops, papaya (which includes black sapote, canistel, mamey sapote,
mango, sapodilla and star apple), and pineapple.>

<B. Toxicological Profile>

<	1. Acute toxicity.  The database includes the following studies for
triflumizole technical: a rat acute oral study with a LD50 of 1.42 g/kg;
a rabbit acute dermal study with a LD50 >5 g/kg; a rat acute inhalation
study with LC50  >3.2 mg/l; a rabbit primary ocular irritation study
which showed mild irritation; a rabbit primary dermal irritation study
which showed no irritation; a guinea pig dermal sensitization study
which showed slight dermal sensitization potential. The database also
includes the following studies for Procure 480SC: a rat acute oral study
with a LD50 >2 g/kg; a rabbit acute dermal study with a LD50 >5 g/kg; a
rat acute inhalation study with a LC50 >3.3 mg/l; a rabbit primary
ocular irritation study which showed slight irritation; a rabbit primary
dermal irritation study which showed no irritation; a guinea pig dermal
sensitization study which was negative for skin sensitization. Acute
neurotoxicity study of triflumizole in rats. Male and female rats were
administered a single dose of triflumizole by oral gavage at levels of
0, 25, 100, 200 (female) and 400 (male) mg/kg and observed for 15 days.
Decreased motor activity was noted 3 to 6 hours post exposure in male
and female rats at 100 mg/kg and above. Functional Observational Battery
(FOB) effects included a decrease rearing counts in females, decreases
in forelimb and hind limb grip strength in males and forelimb grip
strength in females at 100 mg/kg and above. The NOEL was considered to
be 25 mg/kg based on clinical findings and functional observational
battery evaluations at 100 mg/kg.>

<	2. Genotoxicty. Triflumizole was negative in all genotoxicity assays
including: Ames assay in S. typhimurium, gene conversion assay in yeast
strain D4, REC assay in B. subtilis, unscheduled DNA synthesis (UDS)
assay in cultured rat hepatocytes, chromosome aberration assay in
cultured Chinese hamster lung (CHL) cells and a mouse micronucleus
assay.>

<	3. Reproductive and developmental toxicity. In a developmental
toxicity study, triflumizole was administered by oral gavage to
pregnant, female Sprague Dawley rats at dosage levels of 0, 10, 35 or
120 mg/kg/day. Maternal toxicity, as evidenced by a substantial
reduction in body weight gain, was seen at 35 and 120 mg/kg/day. At
these dosage levels there was a decrease in fetal viability in the form
of late resorptions. There were no teratogenic effects. The no observed
effect level (NOEL) for maternal and developmental toxicity was 10
mg/kg/day.

Triflumizole was also administered by oral gavage to pregnant, female
New Zealand White rabbits at dosage levels of 0, 5, 25, or 50 mg/kg/day.
Maternal toxicity was observed at a dose level of 50 mg/kg/day as
demonstrated by a reduction in body weight gain. There were no
developmental or teratogenic effects. The NOEL for maternal toxicity was
25/mg/kg/day and the NOEL for developmental toxicity was greater than 50
mg/kg/day.

The reproductive toxicity of triflumizole was evaluated in rat
reproduction study, conducted on three generations, at dietary
concentrations of 0, 30, 70 and 170 ppm. Fertility was not affected by
treatment. There was an increase in placental weight in the Flb, F2b and
F3b litters and a statistically significant increase in gestation length
in the high dose group at the F1a interval and at all three dose levels
at the F3a interval. Critical review of the gestation length data
demonstrated that theNOEL for reproductive effects in this study is 70
ppm (MRID # 47136402), which was the original conclusion of the study
director at Life Science Research. This is based on the increase in
gestation length seen at 170 ppm in two of six matings. In addition, the
NOEL for systemic parental toxicity was greater than 170 ppm and the
NOEL for developmental toxicity was 70 ppm (3.5 mg/kg/day) based upon
increased incidences of hydroureter and space between the body wall and
organs.>

<	4. Subchronic toxicity. To assess sub-acute dermal toxicity,
triflumizole was applied to the backs of male and female Sprague Dawley
rats for 6 hours per day for three weeks at dose levels of 10, 100 and
1000 mg/kg/day.  Female rats exposed to 1000 mg/kg/day exhibited mild
fatty vacuolation in the liver, which was within the range of normal
biological variation.  Therefore, the no-observed effect level (NOEL)
for subchronic dermal toxicity in rats was considered to be greater than
1000 mg/kg/day.

90 Day Neurotoxicity Study of Triflumizole in Rats. Male and female rats
were administered triflumizole in the diet at levels of 70, 700 or 2000
ppm (4.1, 40.9, 117.3 mg/kg/day male and 4.9, 47.8, and 133.3 mg/kg/day
females) for a period of 90 days. The NOEL for general toxicity was 70
ppm based on body weight (significantly higher in males at 700 ppm and
significantly lower in females at 2000 ppm), food consumption (lower in
females at 2000 ppm), hematology (values were slightly lower in males
and females at 2000 ppm and at week 4 in the 700 ppm dose group) and
pathology evaluations (higher in mean and relative liver weights in
males an females at 700 and 2000 ppm, hepatocellular hypertrophy in
males and females at 700 and 2000 ppm). The NOEL for neurotoxicity was
2000 ppm.>

<	5. Chronic toxicity. Triflumizole was fed to male and female beagle
dogs for one year at dietary concentrations of 0, 100, 300 and 1,000 ppm
to assess chronic toxicity. At a dosage level of 1,000 ppm there was an
increase in serum liver enzymes and a decrease in RBC concentration. The
NOEL for chronic toxicity in dogs was 300 ppm (7.5 mg/kg/day).

Triflumizole was fed to male and female Sprague Dawley rats for two
years at dietary concentrations of 0, 100, 400 and 1,600 ppm to assess
chronic toxicity. At the high dose level there was a substantial
reduction in body weight gain in males and females. At the mid and high
dose levels there was an increase in liver weight. Fatty vacuolization
of the liver was seen at all dose levels and hepatocytic hypertrophy was
seen in high and mid-dose males and females. Female rats given 400 or
1,600 ppm were confined to hepatocytic fatty vacuolation and hypertrophy
in females. These changes were less severe than those seen in rats given
400 or 1,600 ppm and were considered by the laboratory to be indicative
of adaptive metabolic change.   No evidence of oncogenic effects were
demonstrated in rats.  The dietary level of 100 ppm (5 mg/kg/day) is
considered to be a NOEL. >

<	6. Animal metabolism. Triflumizole, [14C-Phenyl]
1-(1-((4-chloro-2-trifluoromethylphenyl)imino)-2-propoxyethyl)-1H-imidaz
ole, was found to be rapidly absorbed and excreted in rats. Two days
after oral dosing, 78% was found to be excreted in the urine and 20% in
the feces. No sex difference was noted. It appears that the loss of the
imidazole ring was the basic step in the metabolic pathway of the
fungicide in mammals.  The elimination of the imidazole ring yielded
initially N-(4-chloro-2-trifluoromethylphenyl)-n-propoxyacetamidine
(FM-6-1), and N-(4-chloro-2trifluoromethyphenyl-n-propoxyacetanilide
(FD-1-1). Other hydroxylated  metabolites identified (free, or as
sulfate/glucuronide conjugates) included, amoung others,
N-(4-chloro-2-trifluoromethylphenyl)-hydroxyacetamidine (FM-8-1);
4-chloro-2-trifluoromethyl-hydroxyacetanilide (FD-2-1); and
4-chloro-2-trifluoromethyl-6-hydroxyaniline (FA-1-5). >

<	7. Metabolite toxicology. Both plant and animals produce the same
metabolites that were identified in the metabolism studies; therefore,
the toxicity of the metabolites has essentially been evaluated in the
rat toxicology studies.>

<	8. Endocrine disruption.[In the rat reproduction study there was an
increase in placental weight in females at the high dose level of 170
ppm. There was also a biologically significant increase in gestation
length in high dose F0 and F2 females (Fla and F3a intervals). The NOEL
for endocrine effects is 70 ppm (3.5 mg/kg/day).>

<C. Aggregate Exposure>

<	1. Dietary exposure. [\Based on dietary, drinking water and
non-occupational exposure assessments, there is reasonable certainty of
no harm to the US population, any population subgroup, or infants and
children from acute or chronic exposure to triflumizole.>

<	i. Food. Chronic dietary exposures were estimated utilizing Dietary
Exposure Evaluation Model software with Food Commodity Intake Database
(DEEM-FCID), version 2.16. EPA’s most recent estimate of chronic
estimated dietary exposures for triflumizole are reported in the August
23, 2006, Federal Register notice which established emergency exemption
tolerances on a variety of crops. In the assessment, EPA used a mixture
of anticipated residues (i.e., mean residues from field trials) and
tolerances for the different crops. EPA included percent crop treated
information from Biological and Economic Analysis Division (BEAD) for
apples, grapes and pears, while all others were assumed to be 100%
treated. EPA used modified processing factors for apples and grapes
based on previously submitted studies, while default processing factors
were used for all other foods. EPA also included an estimated
concentration in drinking water of 40 ppb, which is the chronic (annual
average) concentration in surface water generated by the FIRST model in
the residue file. In the August 23, 2006, Federal Register notice, EPA
used a cPAD of 0.015 mg/kg/day.  Since that time Chemtura has
resubmitted documentation supporting a revised cPAD for triflumizole of
0.035 mg/kg/day (MRID # 47136402).  The revised cPAD will be used in
this assessment.  The total chronic dietary exposures are estimated to
be 37.3% of the cPAD for the general US population, 16.1% for all
infants, 42.0% for children aged 1-2 years old, and 43.9% for children
aged 3-5 years old.  Chronic dietary exposures below 100% of the cPAD
are reasonably anticipated to result in no harm to exposed populations.

For the acute assessment, EPA’s August 23, 2006, assessment assumed
tolerance-level residues, and 100% crop treated for all crops. EPA used
modified processing factors for apples and grapes based on previously
submitted studies, while default processing factors were used for all
other foods. Drinking water was included directly into the dietary
assessment using the acute (peak) concentration for surface water (191
ppb) estimated by the FIRST model. For this updated assessment, an acute
residue file was created using all the information and assumptions from
the EPA assessment and then adding the proposed crops assuming
tolerance-level residues, 100% crop treated and default processing
factors. Acute exposures were calculated using DEEM-FCID version 2.16.
The acute population adjusted dose (aPAD) for triflumizole is 0.25
mg/kg/day for the general population and 0.1 mg/kg/day for females aged
13-49. At the 95th percentile, which is the appropriate point of
comparison for this conservative Tier 1 acute dietary assessment, the
estimated acute exposures range from 23.39% of the aPAD for all infants
to 41.49% of the aPAD for children aged 1-2 years old. For females aged
13-49 years old, the 95th percentile acute dietary exposure is 70.56% of
the subpopulation-specific aPAD (0.1 mg/kg/day). Acute dietary exposures
below 100% of the aPAD are reasonably anticipated to result in no harm
to exposed populations.>

<	ii. Drinking Water. Tier I screen models FIRST (First Index Reservoir
Screening Tool) and SCI-GRO (Screening Concentrations in Ground Water)
were used to predict estimates of triflumizole concentrations in surface
and groundwater, respectively. Drinking water levels of comparison
(DWLOCs) were estimated and compared to drinking water estimated
concentrations (DWECs) using EPA standard operating procedures. DWECs
were obtained from the August 23, 2006, acute exposures. The chronic
DWLOCs are 98 ppb for toddlers, 324 ppb for adult females and 369 ppb
for all adults. The chronic and acute DWECs are below the chronic and
acute DWLOCs, respectively, for all population groups and exposure
durations.>

<	2. Non-dietary exposure. There are no registered or proposed uses for
application by homeowners. For the proposed residential uses, only
professional handlers would apply triflumizole to woody ornamentals
(trees, shrubs, vines). Triflumizole is not used or proposed for use on
lawns or turf. Therefore, residential exposure is not likely.>

<D. Cumulative Effects>

<	The potential for cumulative effects of triflumizole, an imidazole,
and other substances that have a common mechanism of toxicity was
considered. The mammalian toxicity of triflumizole is well defined. No
reliable information exists to indicate that toxic effects produced by
triflumizole would be cumulative with those of any other chemical
compounds. Therefore, consideration of a common mechanism of toxicity
with other compounds is not appropriate. Thus, only the potential risks
of triflumizole are considered in the aggregate exposure assessment.   >

<E. Safety Determination>

<	U.S. population. i. Short-Term Risk.  The acute population adjusted
dose (aPAD) for triflumizole is 0.25 mg/kg/day for the general
population and 0.1 mg/kg/day for females aged 13-49.   Acute dietary
exposure to children (1-2 yrs) was 0.1037 mg/kg/day and was 41.49% of
the aPAD. Acute dietary exposure to females 13-49 yrs was 0.0706
mg/kg/day, and was 70.56% of the aPAD. The acute drinking water level of
concern (DWLOC) was calculated to be 658 ppb, and the model-predicted
acute EECs of 191 ppb for surface water and 0.12 ppb for groundwater are
less than this DWLOC. Therefore, acute aggregate exposure from
triflumizole is not expected to exceed the aPAD.

ii. Chronic Risk. In the August 23, 2006, Federal Register Notice, EPA
used a cPAD of 0.015 mg/kg/day. Since that time, Chemtura has
resubmitted documentation supporting a revised cPAD for Triflumizole of
0.035 mg/kg/day (MRID# 47136402). The chronic Population Adjusted Dose
(cPAD) of 0.035 mg/kg bw/day was based on the NOEL of 3.5 mg/kg/day from
the rat reproduction study, a 100x uncertainty factor, and a 1x FQPA
safety factor. The chronic dietary exposure to the general U.S.
population was 0.0130 mg/kg/day and was 37.3% of the cPAD. The chronic
dietary exposure to children (1-2 yrs) was 0.0147 mg/kg/day and 42.0% of
the cPAD. The chronic DWLOC was calculated to be 160 ppb, and the
model-predicted chronic EECs of 40 ppb for surface water and 0.12 ppb
for groundwater are less than this DWLOC. Therefore, chronic aggregate
exposure from triflumizole is not expected to exceed the cPAD.>

<	2. Infants and children. Acute dietary exposure to children (1-2 yrs)
was 0.1006 mg/kg/day and was 40.23% of the aPAD. The chronic dietary
exposure to children (3-5 yrs) was 0.0144 mg/kg/day and 41% of the
cPAD.>

<F. International Tolerances>

<	Maximum Residue Limits have been established for Chinese cabbage, kale
turnip greens and leafy greens in Japan at 1.0 ppm.>