[Federal Register Volume 84, Number 77 (Monday, April 22, 2019)]
[Notices]
[Pages 16749-16751]
[FR Doc No: 2019-07991]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85665; File No. SR-CboeBYX-2019-004]

Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Extend
the Pilot Program Related to BYX Rule 11.18, Trading Halts Due to
Extraordinary Market Volatility, to the Close of Business on October
18, 2019

April 16, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 12, 2019, Cboe BYX Exchange, Inc. (the ``Exchange'' or
``BYX'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Exchange
filed the proposal as a ``non-controversial'' proposed rule change
pursuant to Section 19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-
4(f)(6) thereunder.\4\ 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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe BYX Exchange, Inc. (``BYX'' or the ``Exchange'') is filing
with the Securities and Exchange Commission (the ``Commission'') a
proposed rule change to extend the pilot program related to BYX Rule
11.18, Trading Halts Due to Extraordinary Market Volatility, to the
close of business on October 18, 2019. The text of the proposed rule
change is attached as Exhibit 5 [sic].
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/byx/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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

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

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

1. Purpose
    BYX Rules 11.18(a) through (d), (f) and (g) describe the
methodology for determining when to halt trading in all stocks due to
extraordinary market volatility, i.e., market-wide circuit breakers.
The market-wide circuit breaker mechanism was approved by the
Commission to operate on a pilot basis, the term of which is to
coincide with the pilot period for the Plan to Address Extraordinary
Market Volatility Pursuant to Rule 608 of Regulation NMS (the ``LULD
Plan'' or ``Plan''),\5\ including any extensions to the pilot period
for the Plan. The Commission published an amendment to the LULD Plan
for it to operate on a permanent, rather than pilot, basis on December
18, 2018,\6\ and the Commission approved that amendment on April 11,
2019.\7\
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    \5\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012) (the ``Limit Up-Limit Down
Release'').
    \6\ See Securities Exchange Act Release No. 84843 (December 18,
2018), 83 FR 66464 (December 26, 2018) (Amendment No. 18 Proposing
Release).
    \7\ See Securities Exchange Act Release No. 85623 (April 11,
2018) (Federal Register publication pending) (Amendment No. 18
Approval Order).
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    Market-wide circuit breakers provide an important, automatic
mechanism that is invoked to promote stability and investor confidence
during a period of significant stress when securities markets
experience extreme broad-based declines. All U.S. equities exchanges
have similar rules related to market-wide circuit breakers, which are
designed to slow the effects of extreme price movement through
coordinated trading halts across securities markets when severe price
declines reach levels that may exhaust market liquidity. Market-wide
circuit breakers provide for trading halts in all equities markets
during a severe market decline as measured by a single-day decline in
the S&P 500 Index.
    Pursuant to BYX Rule 11.18, a market-wide trading halt will be
triggered if the S&P 500 Index declines in price by specified
percentages from the prior day's closing price of that index.
Currently, the triggers are set at three circuit breaker thresholds: 7%
(Level 1), 13% (Level 2) and 20% (Level 3). A market decline that
triggers a Level 1 or Level 2 circuit breaker after 9:30 a.m. ET and
before 3:25 p.m. ET would halt market-wide trading for 15 minutes,
while a similar market decline at or after 3:25 p.m. ET would not halt
market-wide trading. A market decline that triggers a Level 3 circuit
breaker, at any time during the trading day, would halt market-wide
trading for the remainder of the trading day. The Exchange proposes to
amend BYX Rule 11.18 to untie the market-wide circuit breaker pilot
program's effectiveness from that of the LULD Plan and to extend the
pilot's effectiveness to the close of business on October 18, 2019.
    In addition, the Exchange proposes to amend BYX Rule 11.18 such
that the pilot only applies to the provisions of paragraphs (a) through
(d), (f) and (g) of BYX Rule 11.18--i.e., the provisions related to the
market-wide circuit breaker mechanism, and not paragraph

(e), which discusses provisions implementing the LULD Plan.\8\ The
Exchange is required by the LULD Plan to establish, maintain, and
enforce written policies and procedures that are reasonably designed to
comply with the limit up-limit down and trading pause requirements
specified in the Plan. BYX Rule 11.18(e) states that the Exchange is a
Participant in the LULD Plan, and requires that members comply with the
provisions of the Plan. Furthermore, BYX Rule 11.18(e) describes order
handling performed by the Exchange to maintain compliance with the LULD
Plan. Specifically, the rule: (1) Provides that the System shall not
display or execute buy (sell) interest above (below) the Upper (Lower)
Price Bands, unless such interest is specifically exempted under the
Plan; and (2) describes how the System re-prices and/or cancels buy
(sell) interest that is priced or could be executed above (below) the
Upper (Lower) Price Band. With the approval of the LULD Plan to operate
on a permanent basis, the Exchange believes that the provisions of BYX
Rule 11.18(e) should similarly be permanent, thus ensuring continued
compliance with the Plan.
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    \8\ Paragraph (e) of BYX Rule 11.18, which is being made
permanent, is subject to a pilot coterminous with the LULD Plan
today.
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    The Exchange intends to file a separate proposed rule change with
the Commission to operate the provisions of paragraphs (a) through (d),
(f) and (g) of BYX Rule 11.18 on a permanent, rather than pilot, basis.
Extending the effectiveness of such provisions to the close of business
on October 18, 2019 should provide the Commission adequate time to
consider whether to approve the Exchange's separate proposal to operate
the market-wide circuit breaker mechanism on a permanent basis.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the requirements of Section 6(b) of the Act,\9\ in general, and Section
6(b)(5) of the Act,\10\ in particular, in that it is designed to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, to promote just and equitable principles of
trade, and, in general, to protect investors and the public interest
and not to permit unfair discrimination between customers, issuers,
brokers, or dealers.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed rule change promotes just
and equitable principles of trade in that it promotes transparency and
uniformity across markets concerning when and how to halt trading in
all stocks as a result of extraordinary market volatility. The Exchange
believes that extending the market-wide circuit breaker pilot program
for an additional six months would ensure the continued, uninterrupted
operation of a consistent mechanism to halt trading across the U.S.
markets while the Commission considers whether to approve the pilot
program on a permanent basis. The proposed rule change would thus
promote fair and orderly markets and the protection of investors and
the public interest. Based on the foregoing, the Exchange believes the
benefits to market participants from the market-wide circuit breaker
mechanism should continue on a pilot basis while the Commission
considers whether to permanently approve those rules.
    The Exchange also believes that it is consistent with the public
interest and the protection of investors to make permanent the order
handling provisions of BYX Rule 11.18. Today, like the market-wide
circuit breaker rules, those rules are operated under a pilot that
coincides with the pilot period for the LULD Plan. Unlike the market-
wide circuit breaker rules, however, these rules directly implement the
requirements of the LULD Plan, including by implementing order handling
that is consistent with the requirements of the Plan. As such, the
Exchange believes that it is appropriate to make these rules permanent
now that the Plan is no longer operating on a pilot basis. Making these
rules permanent would ensure continued compliance by the Exchange and
its members with the requirements of the LULD Plan as the Plan
transitions to permanent status.

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

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange does not
believe that the proposed rule change implicates any competitive issues
because the proposal would ensure the continued, uninterrupted
operation of a consistent mechanism to halt trading across the U.S.
markets while the Commission considers whether to permanently approve
the market-wide circuit breaker mechanism under BYX Rule 11.18. The
Exchange believes that FINRA and other national securities exchange
will also file similar proposals to extend their respective market-wide
circuit breaker pilot programs with the Commission so that the market-
wide circuit breaker mechanism may continue uninterrupted while the
Commission considers whether to approve its operation on a permanent
basis. Furthermore, the proposed rule change would ensure continued
compliance with the requirements of the LULD Plan as it becomes
permanent, which the Exchange believes would not have a significant
impact on competition.

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

    No comments were solicited or received on the proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \11\ and Rule 19b-
4(f)(6) \12\ thereunder.
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    \11\ 15 U.S.C. 78s(b)(3)(A). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Commission has waived this requirement.
    \12\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \13\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\14\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the Exchange
may implement the proposed rule change immediately. The Commission
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest because the Commission
approved making the Plan pilot permanent on April 11, 2019, and
therefore the Exchange's proposed changes to its rules reflecting that
the Plan is now permanent should go into effect immediately. Therefore,
the Commission hereby waives the 30-day operative delay and designates
the

proposed rule change to be operative upon filing with the
Commission.\15\
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    \13\ 17 CFR 240.19b-4(f)(6).
    \14\ 17 CFR 240.19b-4(f)(6)(iii).
    \15\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-CboeBYX-2019-004 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-CboeBYX-2019-004. 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 website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CboeBYX-2019-004 and should be submitted
on or before May 13, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-07991 Filed 4-19-19; 8:45 am]
 BILLING CODE 8011-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM DATE: 28 JAN 2005 SUBJECT: ID# 04TX20. Section 18 Specific Exemption for the Use of Triflumizole on Parsley, Dandelion, Swiss chard, Collards, Kale, Kohlrabi, Mustard Greens, Napa cabbage, Broccoli and Cilantro in Texas. DP#: 306463. Chemical #: 128879. Trade Name: Procure ® 50WS. 40 CFR § 180.476. EPA Reg#: 400 431.

FROM: Jennifer R. Tyler, Chemist Mark I. Dow, Ph. D., Biologist Robert Mitkus, Toxicologist Registration Action Branch 1 ( RAB 1) Health Effects Division ( HED) ( 7509C)

THRU PV Shah, Branch Senior Scientist HED/ RAB1 ( 7509C)

TO: Libby Pemberton/ Robert Forrest, PM Team 05 Registration Division ( RD) ( 7505C)

INTRODUCTION In accordance with 40 CFR 166.20, the Texas Department of Agriculture ( TDA) proposes a Section 18 Specific Emergency Exemption for the use of triflumizole on parsley, dandelion, Swiss chard, collards, kale, kohlrabi, mustard greens, Napa cabbage, broccoli and cilantro to control Powdery Mildew. This is the first year TDA has requested this Emergency Exemption. The proposed program will entail the application of 63,000 oz. of Procure 50WS [ 1,969 pounds active ingredient ( a. i.)] on a total of 5,250 acres of turnip greens ( 200 acres), broccoli ( 1000 acres), mustard greens ( 1800 acres), parsley ( 600 acres), dandelion ( 150 acres), Swiss chard ( 250 acres), kohlrabi ( 300 acres), Napa cabbage ( 150 acres), kale ( 500 acres), and cilantro ( 300 acres) starting October 1, 2003.

NOTE: HED recently completed a Section 3 risk assessment for the use of triflumizole on strawberries, cucurbit vegetables, cherries and hazelnuts ( Memo, J. Tyler, et al. 4/ 25/ 02; D280864). This document contains only those aspects of the risk assessment which are affected by the addition of this new use of triflumizole on parsley, dandelion, Swiss chard, collards, kale, 2 kohlrabi, mustard greens, Napa cabbage, broccoli and cilantro. Dietary, occupational and aggregate risk were re evaluated based on the addition of the aforementioned crops to the triflumizole use pattern.

SUMMARY Triflumizole is an imidazole fungicide that inhibits ergosterol biosynthesis in fungi. Ergosterol is a sterol which is thought to function as a stabilizer for the membranes that make up the cell wall of fungi. Triflumizole is currently registered for use on apples, cherries, grapes, pears, strawberries, cucurbit vegetables and filberts as well as ornamentals in greenhouses, shadehouses, nurseries ( including Christmas tree/ conifer plantations), and interiorscapes. There are currently no registered or proposed homeowner applicator uses. The proposed residential applications of triflumizole will be made by commercial applicators only.

RECOMMENDATIONS Provided the label is amended as specified on page 10, the toxicology, chemistry and occupational/ residential exposure databases are adequate to support a time limited tolerance of 7.0 ppm for the combined residues of triflumizole and its metabolites containing the 4 chloro 2 trifluoromethylaniline moiety, calculated as the parent compound, in/ on the following RACs: parsley, leaves at 9.0 ppm; dandelion, leaves at 7.0 ppm; Swiss chard at 7.0 ppm; collards at 9.0 ppm; kale at 9.0 ppm; kohlrabi at 9.0 ppm; mustard greens at 9.0 ppm; Napa cabbage at 9.0 ppm; broccoli at 1.0 ppm; and cilantro at 9.0 ppm.

HAZARD CHARACTERIZATION In HED's most recent human health risk assessment, the following toxicity studies were determined to be data gaps: a 28 day rat inhalation study ( GLN 870.3465), acute rat neurotoxicity study ( GLN 870.6200), and subchronic rat neurotoxicity study ( GLN 870.6200). The acute and sub chronic neurotoxicity studies have been submitted, reviewed by HED and determined to be acceptable ( R. Fricke, TXR# 0052656). As a result the following has changed: 1) selection of an acute endpoint for the general U. S. population ( including infants and children); and 2) the removal of the 3x database uncertainty factor ( UF DB ). All other aspects of the most recent risk assessment remain unchanged. Updated toxicity profile and dose and endpoint selection tables can be found as Attachment 1.

Food Quality Protection Act ( FQPA) Considerations The 2/ 17/ 02 HED hazard identification assessment review committee ( HIARC) meeting for triflumizole took place before the current 10x FQPA Policy [ Determination of the Appropriate FQPA Safety Factor( s) in Tolerance Assessment; 2/ 28/ 02] had been implemented by HED in assessing the risks to infants and children. On 3/ 4/ 02, the FQPA Safety Factor Committee ( SFC) reviewed the recommendations of the presenting chemical team from RAB1 to apply a 3x UF DB to the acute and chronic reference doses ( RfDs) for an incomplete database. The HIARC recommended that an acute neurotoxicity study and a subchronic neurotoxicity study be submitted in order to better characterize the neurological effects seen in the rat and mouse acute oral, the rat acute inhalation and the rat chronic studies. The FQPA SFC recommended a UFDB 3 of 3x be applied to the acute and chronic RfDs in order to account for any uncertainty due to the lack of these two neurotoxicity studies ( Memo, D. Nixon, 3/ 17/ 02; TXR NO. 0050571). Acceptable acute and subchronic rat neurotoxicity and subchronic rat neurotoxicity study ( GLN 870.6200). As acceptable acute and sub chronic neurotoxicity studies have been submitted, the risk assessment team has determined that the 3x UF DB should be removed from the acute and chronic RfDs. In addition, the FQPA SFC recommended a special FQPA SF be reduced to 1x. The risk assessment team has re evaluated the quality of the exposure and hazard data; and, based on these data, recommended that the special FQPA SF remain at 1x. The recommendation is based on the following:

° The toxicity database is complete for FQPA assessment. ° There was no quantitative or qualitative evidence of increased susceptibility in the rabbit fetuses following in utero exposure or the rat following pre and post natal exposure in the rat reproduction study. ° There was evidence of qualitative susceptibility in the developmental rat study, however, there are no residual uncertainties, and the use of the developmental No Observed Adverse Effect Level ( NOAEL) and the endpoint for the acute RfD for females 13 50 would be protective of the pre natal toxicity following an acute dietary exposure. ° There is no evidence of increased quantitative or qualitative susceptibility in the rat developmental neurotoxicity study. ° The acute dietary food exposure assessment utilizes existing and proposed tolerance level residues and 100% CT information for all commodities. By using these screening level assessments, actual exposures/ risks will not be underestimated. ° The chronic dietary food exposure assessment utilizes anticipate residues ( ARs) and percent crop treated (% CT) data verified by Biological and Economics Analysis Division ( BEAD) for several existing uses. For all proposed use, tolerance level residue and 100% CT is assumed. The chronic assessment is somewhat refined and based on reliable data and will not underestimate exposure/ risk. ° The dietary drinking water assessment utilizes water concentration values generated by model and associated modeling parameters which are designed to provide conservative, health protective, high end estimates of water concentrations which will not likely be exceeded. ° There are no registered or proposed uses of triflumizole that would result in residential exposure.

Dose Response Assessment Acute Dietary Endpoint ( General U. S. Population): The rat acute neurotoxicity study was chosen to select the endpoint for establishing the acute RfD of 0.25 mg/ kg for the general U. S. population, including infants and children. The NOAEL of 25 mg/ kg/ day was based on FOB findings ( neuromuscular impairment) and decreased locomotor activity observed at the LOAEL of 100 mg/ kg/ day. A 100 fold UF ( 10x for interspecies extrapolation and 10x for intraspecies variation) was incorporated in the acute RfD. The risk assessment team has evaluated the quality of the exposure and hazard data; and, based on these data, recommended that the special FQPA SF remain at 1x. Thus, the acute population adjusted dose ( aPAD) is 0.25 mg/ kg/ day for the general U. S population, including infants and children.

Acute Dietary Endpoint ( Females 13 49 Years Old): The rat developmental studies were chosen to select the endpoint for establishing the acute RfD of 0.1 mg/ kg for the subpopulation females 13 50 years old. The developmental NOAEL of 10 mg/ kg/ day was based on decreased numbers of viable fetuses, increased dead or resorbed fetuses, increased numbers of late resorptions, decreased fetal body weight, and increased incidences of cervical ribs observed at the LOAEL of 35 mg/ kg/ day. A 100 fold UF ( 10x for interspecies extrapolation and 10x for intraspecies variation) was incorporated in the acute RfD. The FQPA SFC determined that a special FQPA safety factor of 1x is applicable for acute dietary risk assessment ( females 13 49 years old). The risk assessment team has re evaluated the quality of the exposure and hazard data; and, based on these data, recommended that the special FQPA SF remain at 1x. Thus, the aPAD is 0.1 mg/ kg/ day.

Chronic Dietary Endpoint: The rat reproduction study was used to select the endpoint for establishing the chronic RfD of 0.015 mg/ kg/ day. The NOAEL of 1.5 mg/ kg/ day was based on 4 increased gestation length in the dams of the F 3a interval at the LOAEL of 3.5 mg/ kg/ day. A 100 fold UF ( 10x for interspecies extrapolation and 10x for intraspecies variation) was incorporated into the chronic RfD. The FQPA SFC determined that a special FQPA safety factor of 1x is applicable for chronic dietary risk assessment. The risk assessment team has reevaluated the quality of the exposure and hazard data; and, based on these data, recommended that the special FQPA SF remain at 1x. Thus, the chronic population adjusted dose ( cPAD) is 0.015 mg/ kg/ day.

EXPOSURES AND RISKS In examining aggregate exposure, FQPA directs EPA to consider available information concerning exposures from pesticide residues in food and all other non dietary, non occupational exposures ( i. e., residential). The primary non food sources of non occupational exposure is drinking water ( from both groundwater and surface water). There are no uses that would result in residential exposure to children. In evaluating food exposures, EPA takes into account varying consumption patterns of major identifiable subgroups of consumers, including infants and children.

Dietary Risks from Food A triflumizole acute [ separate assessment for general U. S. population ( including infants and children) and females 13 49 years old] and chronic dietary exposure ( general U. S. population and all population subgroups) assessments were conducted using the Dietary Exposure Evaluation Model  Food Commodity Intake Database   ( DEEM FCID   ; ver. 2.03) program which incorporates consumption data from USDA's Continuing Surveys of Food Intakes by Individuals ( CSFII), 1994 1996 and 1998 ( Memo, J. Tyler, D312453, 1/ 28/ 05). The 1994 96, 98 data are based on the reported consumption of more than 20,000 individuals over two nonconsecutive survey days. Foods " as consumed" ( e. g., apple pie) are linked to EPA defined food commodities ( e. g. apples, peeled fruit  cooked; fresh or N/ S; baked; or wheat flour  cooked; fresh or N/ S, baked) using publicly available recipe translation files developed jointly by USDA/ ARS and EPA. 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.

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

For acute exposure assessments, individual one day food consumption data are used on an individual by individual basis. The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic ( Tier 1 or Tier 2) exposure assessment, or " matched" in multiple random pairings with residue values and then summed in a probabilistic ( Tier 3/ 4) assessment. The resulting 5 distribution of exposures is expressed as a percentage of the aPAD on both a user ( i. e., those who reported eating relevant commodities/ food forms) and a per capita ( i. e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis. However, for Tiers 1 and 2, significant differences in user vs. per capita exposure and risk are identified and noted in the risk assessment.

HED's level of concern is when the exposure is greater than 100% of the PAD. That is, estimated exposures above this level are of concern, while estimated exposures at or below this level are not of concern. The DEEM FCID   analysis estimates the dietary exposure of the U. S. population and 26 population subgroups. The results reported in Table 1 are for the U. S. Population, all infants (< 1 year old), children 1 2, children 3 5, children 6 12, youth 13 19, females 13 49, males 20 49, and adults 50+ years.

Acute Dietary Exposure Estimates: Acute dietary exposure assessments were conducted for the general U. S. population ( including infants and children) and females 13 49 years old using tolerance level residues and 100% CT information for all registered and proposed uses). These assessments conclude that the acute dietary exposure estimates are below HED's level of concern (< 100% aPAD) for the general U. S. population ( including infants and children; # 21% aPAD) and females 13 49 years old ( 9% aPAD).

Chronic Dietary Exposure Estimates: A refined, chronic dietary exposure assessment was performed for the general U. S. population and various population subgroups using anticipated residues ( ARs) from average field trial residues for apple, grape, pear, cherry, cucurbit, strawberry, and milk commodities; registered and proposed tolerance for all other commodities; % CT information for apples, grapes and pear commodities; and 100% CT information for all other uses). This assessment concludes that the chronic dietary exposure estimates are below HED's level of concern (< 100% cPAD) for the general U. S. population ( 5% cPAD) and all population subgroups. The most highly exposed population subgroup is Children 1 2 years old at 13% cPAD.

Table 1. Summary of Dietary Exposure and Risk for Triflumizole.

Population Subgroup Acute Dietary 1 Chronic Dietary 2 Dietary Exposure ( mg/ kg/ day) % aPAD Dietary Exposure ( mg/ kg/ day) % cPAD U. S. Population ( total) 0.013798 6 0.000788 5 All Infants (< 1 year old) 0.028361 11 0.000637 4 Children 1 2 years old 0.052241 21 0.001967 13 Children 3 5 years old 0.035753 14 0.001768 12 Children 6 12 years old 0.016749 7 0.001019 7 Youth 13 19 years old 0.008281 3 0.000749 5 Table 1. Summary of Dietary Exposure and Risk for Triflumizole.

Population Subgroup Acute Dietary 1 Chronic Dietary 2 Dietary Exposure ( mg/ kg/ day) % aPAD Dietary Exposure ( mg/ kg/ day) % cPAD U. S. Population ( total) 0.013798 6 0.000788 5 6 Adults 20 49 years old 0.008492 3 0.000599 4 Adults 50+ years old 0.009758 4 0.000725 5 Females 13 49 years old 0.009380 9 0.000593 4 1. Acute dietary endpoints of 0.25 mg/ kg/ day and 0.1 mg/ kg/ day applies to the general U. S. population ( including infants and children) and females 13 49 years old, respectively. 2. Chronic dietary endpoint of 0.015 mg/ kg/ day applies to the general U. S. population and all population subgroups.

Dietary Risks From Drinking Water The Environmental Fate and Effects Division ( EFED) provided revised Tier 1 drinking water EECs to include the degradates containing the 4 chloro 2 trifluoromethylaniline moiety ( Memo, S. Ramasamy, 3/ 13/ 02). The EECs derived for total residues, namely parent and degradates containing the 4 chloro 2 trifluoromethyl aniline moiety, as Metabolism Assessment Review Committee ( MARC) suggested, are based on certain assumptions in the absence of some fate studies for degradates ( i. e., mobility studies) and may be associated with uncertainties in the water assessment. Tier I models Screening Concentration in Ground Water ( SCI GROW) and FQPA Index Reservoir Screening Tool ( FIRST) were used to derive the surface water and ground water EECs, respectively. Application to cherries provided the highest exposure scenario ( 0.5 lb ai/ A/ application × 6 applications/ year = 3.0 lb ai/ A/ year); therefore, the drinking water EECs were derived for cherries. The ground water EEC was 0.12 ppb. The acute and chronic surface water EECs were 191 and 40 ppb, respectively.

Aggregate Risks Aggregate risk assessments were performed for acute and chronic aggregate exposure ( food + drinking water). Short, intermediate and long term aggregate risk assessments were not performed because, there are no registered or proposed residential uses for triflumizole. A cancer aggregate risk assessment was not performed because triflumizole is not carcinogenic. All potential exposure pathways were assessed in the aggregate risk assessment.

Since HED does not have ground and surface water monitoring data to calculate a quantitative aggregate exposure, drinking water levels of comparison ( DWLOCs) were calculated. A DWLOC is a theoretical upper limit on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide through food, drinking water, and residential uses. A DWLOC will vary depending on the toxicity endpoint, drinking water consumption, body weights, and pesticide uses. Different populations will have different DWLOCs. HED uses DWLOCs in the risk assessment process to assess potential concern for exposure associated with pesticides in drinking water. DWLOC values are not regulatory standards for drinking water.

To calculate DWLOCs, the dietary food estimates ( from DEEM FCID   ) were subtracted from 7 the PAD value to obtain the maximum water exposure level. DWLOCs were then calculated using the standard body weights and drinking water consumption figures: 70kg/ 2L ( adult male and U. S. population), 60 kg/ 2L ( adult female and youth), and 10kg/ 1L ( infants and children).

Acute Aggregate Risk Assessment ( Food and Drinking Water): The acute aggregate risk assessment considered exposure from food and water. The acute dietary exposure estimates are below HED's level of concern (< 100% aPAD) for the general U. S. population and all population subgroups ( see Table 1). The EECs generated by EFED are less than HED's DWLOCs. Acute aggregate risk to triflumizole, as a result of all registered and proposed uses, is less than HED's level of concern. Table 2 summarizes the acute aggregate risk to triflumizole.

Table 2. Acute Aggregate Risk to Triflumizole Population aPAD ( mg/ kg/ day) Acute Food Exposure ( mg/ kg/ day) Max Acute Water Exposure1 ( mg/ kg/ day) Ground Water EEC2 ( ppb) Surface Water EEC2 ( ppb) Acute DWLOC3 ( ppb)

General U. S. Population 0.25 0.013798 0.237202 0.12 191 8300 All Infants (< 1 year old) 0.028361 0.221639 2200 Children 1 2 years old 0.052241 0.197759 2000 Children 3 5 years old 0.035753 0.214247 2100 Children 6 12 years old 0.016749 0.237251 2400 Youth 13 19 years old 0.008281 0.241719 7300 Adults 20 49 years old 0.008492 0.241508 8500 Adults 50+ years old 0.009758 0.240242 8400 Females 13 49 years old 0.1 0.009380 0.090620 0.12 191 2700 1. maximum acute water exposure ( mg/ kg/ day) = aPAD ( mg/ kg/ day)  acute food exposure from DEEM ( mg/ kg/ day); no res. exp. 2. FIRST and SCI GROW modeling EECs ( Tier 1); cherry application used ( 3.0 lb ai/ A/ year) 3. DWLOC( µ g/ L) = ( allowable water exposure ( mg/ kg/ day) x body weight ( kg) x 1000 µ g/ mg) ÷ ( water consumption ( liters))

Chronic Aggregate Risk Assessment ( Food and Drinking Water): The chronic aggregate risk assessment considered exposure from food and water. The chronic dietary exposure estimates are below HED's level of concern (< 100% cPAD) for the general U. S. population and all population subgroups ( see Table 1). The EECs generated by EFED are less than HED's DWLOCs. Chronic aggregate risk to triflumizole, as a result of all registered and proposed uses, is less than HED's level of concern. Table 3 summarizes the chronic aggregate risk to triflumizole. 8 Table 3. Chronic Aggregate Risk to Triflumizole Population cPAD ( mg/ kg/ day) Chronic Food Exposure ( mg/ kg/ day) Max Chronic Water Exposure1 ( mg/ kg/ day) Ground Water EEC2 ( ppb) Surface Water EEC2 ( ppb) Chronic DWLOC3 ( ppb)

General U. S. Population 0.015 0.000788 0.014212 0.12 40 500 All Infants (< 1 year old) 0.000637 0.014363 140 Children 1 2 years old 0.001967 0.013033 130 Children 3 5 years old 0.001768 0.013232 130 Children 6 12 years old 0.001019 0.013981 140 Youth 13 19 years old 0.000749 0.014251 430 Adults 20 49 years old 0.000599 0.014401 500 Females 13 49 years old 0.000593 0.014407 430 Adults 50+ years old 0.000725 0.014275 500 1 maximum chronic water exposure ( mg/ kg/ day) = cPAD ( mg/ kg/ day)  chronic food exposure from DEEM ( mg/ kg/ day); no res. exp. 2 FIRST and SCI GROW modeling EECs ( Tier 1); cherry application used ( 3.0 lb ai/ A) 3 DWLOC( µ g/ L) = ( allowable water exposure ( mg/ kg/ day) x body weight ( kg) x 1000 µ g/ mg) ÷ ( water consumption ( liters))

Occupational Exposure and Risk Assessment See Attachment 2 for a summary of the proposed use pattern. The label requires applicators and other handlers to wear long sleeved shirt, long pants, shoes plus socks and chemical resistant gloves made of any waterproof material.

Occupational Handler Exposure: In this case, the most highly exposed occupational pesticide handlers are likely to be a mixer loader using open pour of wettable powder, an applicator using open cab ground boom equipment and an aerial applicator. Based upon the proposed use pattern, HED believes occupational pesticide handlers ( i. e., mixers, loaders, applicators) will be exposed to short term ( 1  30 days) duration exposures. Intermediate term exposures ( 1  6 months) are not expected. Treatment blocks are expected to be small in comparison to typical field crops such as corn, wheat, cotton or soybeans. Although multiple applications are possible, they are separated by 10  14 days. It is expected that private ( i. e., grower) applicators will apply the majority of acres treated.

Private ( i. e., grower) applicators may perform all functions, that is, mix, load and apply the material. The HED Science Advisory Council for Exposure ( ExpoSAC) Policy 12 ( 29 March 2000) directs that although the same individual may perform all those tasks, they shall be assessed separately. " By separating the two job functions, ( i. e., mixing/ loading from application) HED determines the most appropriate levels of personal protection equipment ( PPE) for each aspect of the job without requiring an applicator to wear unnecessary PPE that may be required for mixer/ loaders ( e. g., chemical resistant gloves may only be necessary during the pouring of a liquid formulation)."

Chemical specific data were not available with which to assess pesticide handler exposure. Therefore, surrogate data from studies in the Pesticide Handler Exposure Database ( PHED, Version 1.1, August 1998) were used to estimate mixer/ loader and applicator exposure.

It is HED policy to assess handler exposure and risk using " baseline" PPE which is comprised of long 9 sleeved shirt, long pants, and shoes plus socks and if necessary to assess " baseline" plus the use of protective gloves or other PPE as might be necessary or appropriate. The Procure ® 50 WS label directs pesticide handlers to wear a long sleeved shirt, long pants, chemical resistant, water proof gloves and shoes plus socks. See Table 4 for a summary of estimated exposures and risks to occupational pesticide handlers.

Table 4. Estimated Handler Exposure and Risk from the Use of Triflumizole on Broccoli and Vegetable Greens.

Unit Exposure1 mg a. i./ lb handled Applic. Rate2 ( lb ai/ A) Units Treated3 Per Day ( Acres) Average Daily Dose4 ( mg a. i./ kg bw/ day) NOAEL5 ( mg a. i./ kg bw/ day) MOE6 Mixer/ Loader  Wettable Powder  Open pour Dermal: No Glove 3.7 LC With Glove 0.17 MC Inhal. 0.043 MC 0.1875 lb a. i./ A 350A Dermal: No Glove 0.014 W Glove 0.0065 Inhal 0.047 8.5 No Glove 140 W Glove 160 Applicator  Ground boom  Open Cab Dermal: No Glove 0.014 HC With Glove 0.014 MC Inhal 0.00074 HC 0.1875 lb a. i./ A 200 A Dermal: No Glove 0.00031 W Glove 0.00031 Inhal 0.00046 8.5 No Glove 11,000 W Glove 11,000 Aerial Applicator ( pilots not required to wear gloves)

Dermal: No Glove 0.0022 MC Inhal. 0.000068 MC 0.1875 lb a. i./ A 350A Dermal: No Glove 0.000084 Inhal 0.000074 8.5 No Glove 53,000 1. Unit Exposures are taken from " PHED SURROGATE EXPOSURE GUIDE", Estimates of Worker Exposure from The Pesticide Handler Exposure Database Version 1.1, August 1998. Dermal = Single Layer Work Clothing No Gloves; Single Layer Work Clothing With Gloves; Inhal. = Inhalation. Units = mg a. i./ pound of active ingredient handled. Data Confidence: LC = Low Confidence, MC = Medium Confidence, HC = High Confidence. 2. Applic. Rate. = Taken from the Texas Section 18 request. 3. Units Treated are taken from " Standard Values for Daily Acres Treated in Agriculture"; SOP No. 9.1. Science Advisory Council for Exposure; Revised 5 July 2000; 4. Average Daily Dose = Unit Exposure * Applic. Rate * Units Treated * absorption factor ( 3.5 % dermal; 100 % inhalation ÷ Body Weight ( 60 kg since NOAELs are identified from a developmental study with fetal effects). 5. NOAEL = No Observable Adverse Effect Level ( 8.5 mg a. i./ kg bw/ day for short term dermal and short term inhalation) 6. MOE = Margin of Exposure = No Observable Adverse Effect Level ( NOAEL) ÷ ADD. Short term dermal and short term inhalation exposures are summed and divided into the NOAEL. The dermal and inhalation endpoints are the same and identified from the same study and have the same NOAELs.

A MOE of 100 is adequate to protect occupational pesticide handlers from short term exposures to triflumizole; therefore, these exposures do not exceed HED's level of concern.

Post Application Exposure to Agricultural Workers: There is a potential for agricultural workers to experience post applications exposures to pesticides during the course of typical agricultural activities. HED in conjunction with the Agricultural Re entry Task Force ( ARTF) has identified a number of postapplication agricultural activities that may occur. HED has also identified Transfer Coefficients ( TCs) expressed as cm ² / hr which help describe the amount of foliar dislodgeable pesticide residue that is available to be transferred to agricultural workers during the course of post application agricultural activities.

There were no chemical specific data with which to estimate post application exposures of agricultural workers to dislodgeable residues of triflumizole. Therefore, theoretical estimates of exposure, based on 10 surrogate studies, have been conducted. The ExpoSAC [ Standard Operating Procedure ( SOP) 003.1, Rev. 7 Aug. 2000, Regarding Agricultural Transfer Coefficients; Amended ExpoSAC Meeting notes  13 Sept 01] lists a number of possible post application agricultural activities relative to field corn that result in pesticide exposure to agricultural workers. TCs expressed as cm ² / hr are identified for each of the post application, agricultural activities. The TCs are derived from data in surrogate exposure studies conducted during the various activities listed.

The highest ( i. e., most conservative) TC relative to the subject crops is 5,000 cm ² / hr for hand harvest, thinning or irrigation activities in broccoli. A TC of 2,500 cm ² / hr is identified for hand harvest or thinning of collards, leafy greens, kale and parsley. For this assessment, HED uses the 5,000 cm ² / hr TC as a Tier I, screening level figure.

The transfer coefficients used in this assessment are from an interim transfer coefficient procedure developed by HED's Science Advisory Council for Exposure using proprietary data from the ARTF database ( SOP# 3.1). It is the intention of HED's ExpSAC that this procedure will be periodically updated to incorporate additional information about agricultural practices in crops and new data on transfer coefficients. Much of this information will originate from exposure studies currently being conducted by the ARTF, from further analysis of studies already submitted to the Agency, and from studies in the published scientific literature.

Post application worker exposure is estimated using HED procedure that assumes 20% of the application rate is available as dislodgeable foliar residue on the day of treatment. HED expects postapplication agricultural exposures to scouts ( i. e., crop advisors) or workers involved in irrigation would typically be short term. The total number of acres treated per day is comparatively small and treatment is not expected to be necessary at the same time for all acres on a given farm, therefore scouting after treatment will occur in short term periods of time.

PDR t = DFR t * CF1 * Tc * ET where: PDR t = potential dose rate on day " t" ( mg/ day) DFR t = dislodgeable foliar residue on day " t" ( µ g/ cm2) CF1 = weight unit conversion factor to convert µ g units in DFR value to mg for the daily dose ( 0.001 mg/ µ g) TC = transfer coefficient ( cm2/ hr) ( In this case 5,000 cm2/ hr; ExpoSAC SOP 003.1 Rev. 7 Aug. 2000; amended 13 Sept 01 ExpoSAC meeting Notes). ET = Exposure Time ( hrs) ( 8)

and DFR t = AR * F * ( 1 D) t * CF2 * CF3 where:

AR = Application rate ( lb a. i./ A) ( 0.1875 lb a. i./ A) F = fraction of a. i. retained on foliage ( unitless) D = fraction of residue that dissipates daily ( unitless) t = postapplication day on which exposure is being assessed CF2 = weight unit conversion factor to convert the lbs a. i. in the application rate to µ g for the DFR value ( 4.54 x 108 µ g/ lb) CF3 = Area unit conversion factor to convert the surface area units ( ft2) in the application rate to cm2 for the DFR value ( 1.08 x 10 3 ft2/ cm2 or 2.47 x 10 8 acre/ cm2 if the application rate is per acre).

  DFR = 0.1875 lb a. i./ A * 0.20 * ( 1 0) 0 * 4.54 x 108 µ g a. i./ lb * 2.47 x 10 8A/ cm2 = 0.42 µ g/ cm2 PDR = 042 µ g/ cm2 * 0.001 mg/ µ g * 5,000 cm2/ hr * 8 hr/ day = 16.8 mg a. i./ day * 3.5 % dermal absorption ÷ 60 kg bw = 0.0098 mg a. i./ kg bw/ day Margin of Exposure ( MOE) = NOAEL ÷ PDR   8.5 mg a. i./ kg bw/ day ÷ 0.0098 mg a. i./ kg bw/ day = 870.

An MOE of 100 is adequate to protect agricultural workers from post application exposure to triflumizole. The calculated MOEs > 100 therefore this use does not exceed HED's level of concern. 11 OTHER CONSIDERATIONS Residue Chemistry Triflumizole is an imidazole fungicide that inhibits ergosterol biosynthesis in fungi. Ergosterol is a sterol which is thought to function as a stabilizer for the membranes that make up the cell wall of fungi. Permanent tolerances are established under 40 CFR § 180.476( a) for the combined residues of triflumizole and its metabolites containing the 4 chloro 2 trifluoromethylaniline moiety, calculated as the parent compound, in/ on apples, cherries, grapes, pears, strawberries, and cucurbit vegetables. In addition permanent tolerances for livestock commodities have been established under 40 CFR § 180.476( b) for the combined residues of triflumizole, the metabolite 4 chloro 2 hydroxy 6 trifluoromethylaniline sulfate, and other metabolites containing the 4 chloro 2 trifluoromethylaniline moiety, calculated as the parent compound, in/ on milk; eggs; meat, fat, and meat byproducts ( mbyp) of cattle, goats, hogs, horses, and sheep; and in/ on meat, and mbyp of poultry. A time limited tolerance in conjunction with an Section 18 Emergency Exemption has been established under 40 CFR § 180.476( a) for the combined residues of triflumizole and its metabolites containing the 4 chloro 2 trifluoromethylaniline moiety, calculated as the parent compound, in/ on filberts.

Summary of Proposed Use: See Attachment 2 for a summary of the proposed use pattern. A rotational crop restriction is not included on the label. The label should be amended to include the following plantback intervals ( PBIs) for rotational crops: 30 days for leafy vegetables, and 60 days for root vegetables. Rotation to all other crops is prohibited. Provided these amendments are made, the application scenario is adequately described.

Nature of the Residue  Plants and Livestock: The nature of the residue in fruit is adequately understood based on acceptable metabolism data on apples, cucumbers, grapes, and pears. The results of metabolism studies were extensively discussed in connection with PP# 5G3232 ( Memo, N. Dodd, 7/ 3/ 85). HED concluded that the residues of concern in/ on apples, pears, cucumbers and grapes include the parent compound, triflumizole and its metabolites ( free and conjugates) containing the 4 chloro 2 trifluormethyaniline moiety ( calculated as triflumizole). In a meeting on 2/ 26/ 02, HED MARC concluded that there was no need to revisit the residues of concern in primary crops ( Memo, J. Tyler, 3/ 13/ 02; D280869). The MARC concurred with the current tolerance expression for plants as stated in 40 CFR § 180.476.

There are no livestock feed items associated with the proposed uses; therefore, a discussion of potential transfer of secondary residues to livestock commodities is not relevant to this petition.

Storage Stability: No storage stability data were submitted to support the current action. Previously reviewed data indicate that triflumizole is stable for up to 10 months in frozen cucurbits vegetables ( MRID 449713 01 thru  03; Memo, J. Tyler, 3/ 11/ 02; D271003) and strawberries ( MRID 45375406; J. Tyler, 3/ 11/ 02; D274589) and up to  12 months in frozen cherries ( MRID 44438401; Memo, J. Tyler, 4/ 30/ 01; D242429) and apples and grapes ( MRID 41131203; Memo, S. Malak, 1/ 25/ 90, DEB# s 5479 & 5480). These data support the submitted residue studies on turnips, leaf lettuce and broccoli in which the samples were analyzed within 66, 125, and 65 days of sampling, respectively.

Magnitude of the Residue  Plants: TDA cited the results of crop field trial studies performed on turnip leaves, leaf lettuce and broccoli in Texas in 2003 ( Region 6; one field trial per study). These 12 studies have been submitted to the Agency, and HED has completed a preliminary review of these studies.

Turnip Leaves ( MRID# 46212401): Residues of triflumizole were 4.30 ppm, 8.87 ppm, and 8.11 ppm ( average 7.09 ppm) in turnip leaf samples collected 1 day following the last of 5 applications of Procure ® 50WS at 0.25 lb a. i./ A [ total application rate of 2.5 lb. a. i./ A; 7 day retreatment interval ( RTI); ground airblast applications].

Leaf Lettuce ( MRID# 46212402): Residues of triflumizole were 4.76 ppm, 5.84 ppm, and 6.25 ppm ( average 5.62 ppm) in leaf lettuce samples collected 1 day following the last of 5 applications of Procure ® 50WS at 0.25 lb a. i./ A ( total application rate of 2.5 lb. a. i./ A; 7 day RTI; ground airblast applications).

Broccoli ( MRID# 46212403): Residues of triflumizole were 0.323 ppm, 0.864 ppm, and 0.926 ppm ( average 0.704 ppm) in broccoli samples collected 1 day following the last of 5 applications of Procure ®

50WS at 0.25 lb a. i./ A ( total application rate of 2.5 lb. a. i./ A; 7 day RTI; ground airblast applications).

The available residue data show that residues of triflumizole are # 8.87 ppm in turnip leaves, leaf lettuce and broccoli when treated with a total of 1.25 lb a. i./ A/ year ( 5 applications of 0.25 lb. a. i./ A/ application) with a RTI of 7 days and preharvest inteveral ( PHI) of 1 day. Although the application rates made at 5x the proposed application rate, the submitted data are adequate and support time limited tolerances for the combined residues of triflumizole and its metabolites containing the 4 chloro 2 trifluoromethylaniline moiety, calculated as the parent compound, in/ on the following RACs: parsley, leaves at 9.0 ppm; dandelion, leaves at 7.0 ppm; Swiss chard at 7.0 ppm; collards at 9.0 ppm; kale at 9.0 ppm; kohlrabi at 9.0 ppm; mustard greens at 9.0 ppm; Napa cabbage at 9.0 ppm; broccoli at 1.0 ppm; and cilantro at 9.0 ppm.

Magnitude of the Residue  Livestock: As there are no livestock feed items associated with the proposed uses, data on residues of triflumizole in livestock tissues, milk and eggs are not required to support the current action.

Residues in Rotational Crops: Results of confined and limited field rotational crop studies were reviewed in the HED memoranda dated 3/ 11/ 02 ( Memo, J. Tyler; D274589). HED concluded that the following PBIs are appropriate: 30 days for leafy vegetables, and 60 days for root vegetables. Because quantifiable residues were found in wheat commodities at the longest adequate PBI tested ( 120 days), rotation to wheat and all other crops is not permitted. The petitioner should submit adequate limited field rotational crop data on wheat at PBIs longer than 120 days. Alternatively, the petitioner has the option of submitting a full set of residue field trials on all intended rotational crops other than leafy and root vegetables. The petitioner should amend the proposed Section B to specify the aforementioned rotational crop restrictions.

Analytical Enforcement Method  Plants and Livestock: The methods used in the crop field trials are suitable for data gathering purposes. The gas chromatography/ mass selective detector ( GC/ MSD) method ( Morse Method METH 115, Revision # 3) used in the turnip, leaf lettuce, and broccoli crop field trials has a validated limit of quantitation ( LOQ) of 0.05 ppm. Morse Method METH 115, Revision # 3 converts residues of triflumizole and its aniline containing metabolites to 4 chloro 2 13 trifluoromethylaniline ( FA 1 1) which is then quantified as triflumizole equivalents. A similar GC/ NPD method has been deemed acceptable as a tolerance enforcement method in conjunction with a petition for use on apples, grapes, and pears, and has been forwarded to FDA for inclusion in the Pesticide Analytical Manual ( PAM), Volume II as Method I ( G. Kramer, 12/ 16/ 94). For the purposes of this petition, HED concludes that the current enforcement method is appropriate for enforcement of the tolerance associated with this petition.

There are no livestock feed items associated with the proposed uses; therefore, data collection and tolerance enforcement methods for livestock commodities are not required for the establishment of a tolerance for triflumizole residues in/ on the proposes uses. However, adequate methods are available for determining residues of triflumizole, its sulfate metabolite, and other metabolites containing the 4 chloro 2 trifluromethylaniline moiety in livestock commodities. These methods are listed as Methods II and III in PAM II.

Multiresidue Methods: The Food and Drug Administration ( FDA) PESTDATA database ( PAM Volume I, Appendix I, 3rd edition, 1994) indicates that triflumizole is completely recovered (> 80%) by Multiresidue Protocol D ( PAM I Sections 232.4).

cc: J. Tyler ( RAB1), R. Mitkus ( RAB1), M. Dow ( RAB1) Branch ( 12/ 15/ 04), PV Shah ( 1/ 28/ 05) J. Tyler: 809B: CM# 2: ( 703) 305 5564: 7509C: RAB1 14 Attachment 1. Updated Toxicology Tables.

Toxicity Profile of Triflumizole Technical.

Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.3100 90 Day oral toxicity rodents ( rat) 45498001 ( 1980) Acceptable/ guideline 0, 20, 200, 2000 ppm M: 0, 1.4, 15.3, or 176.5 mg/ kg/ day F: 0, 1.8, 17.2, or 217.9 mg/ kg/ day NOAEL = Males: 15.3 mg/ kg/ day; Females: 17.2 mg/ kg/ day LOAEL = Males: 176.5 mg/ kg/ day; Females: 217.9 mg/ kg/ day based on increased kidney and liver weights and the accumulation of fat droplets in the liver.

870.3100 90 Day oral toxicity rodents ( mouse) 45498002 ( 1980) Acceptable/ guideline 0, 20, 200, 2000 ppm M: 0, 3.2, 33.1, or 380.7 mg/ kg/ day F: 0, 4.2, 42.6, or 466.2 mg/ kg/ day NOAEL = Males: 33.1 mg/ kg/ day; Females: 42.6 mg/ kg/ day LOAEL = Males: 380.7 mg/ kg/ day; Females 466.2 mg/ kg/ day based on reduced growth.

870.3150 90 Day oral toxicity in nonrodents NA NA 870.3200 21/ 28 Day dermal toxicity ( rat) 41706601 ( 1990) Acceptable/ guideline 0, 10, 100, or 1000 mg/ kg/ day 6 hr/ day, 7 d/ week NOAEL $ 1000 mg/ kg/ day LOAEL = not identified 870.3250 90 Day dermal toxicity NA NA 870.3465 90 Day inhalation toxicity NA NA; 28 day inhalation toxicity is data gap 870.3700a Prenatal developmental in rodents ( rat) 45458001 ( 1983) Acceptable/ guideline when considered with MRIDs 00157075 and 00164384 F: 0, 10, 35, or 120 mg/ kg/ day Maternal NOAEL = 10 mg/ kg/ day LOAEL = 35 mg/ kg/ day based on decreased body weight gain and food consumption, and increased placental, spleen and liver weights. Developmental NOAEL = 10 mg/ kg/ day LOAEL = 35 mg/ kg/ day based on decreased numbers of viable fetuses, increased dead or resorbed fetuses, increased numbers of late resorptions, decreased fetal body weight, and increased incidences of cervical ribs.

870.3700a Prenatal developmental in rodents ( rat) 00157075 ( 1986) Acceptable/ non guideline ( complimentary) F: 0 or 3 mg/ kg/ day Must be considered with MRID 45458001 LOAELs/ NOAELs not assigned 870.3700a Prenatal developmental in rodents ( rat) 00164384 ( 1986) Acceptable/ non guideline ( repeat) F: 0, 3, 7, or 35 mg/ kg/ day Must be considered with MRID 45458001 LOAELs/ NOAELs not assigned 870.3700b Prenatal developmental in nonrodents ( rabbit) 00156546 ( 1985) Acceptable/ guideline F: 0, 50, 100, or 200 mg/ kg/ day Maternal NOAEL = 50 mg/ kg/ day LOAEL = 100 mg/ kg/ day based on decreased body weight gains, food consumption, and placental weights. Developmental NOAEL = 50 mg/ kg/ day LOAEL = 100 mg/ kg/ day based on decreased 24 hour survival, decreased placental weights, and increased fetal and litter incidences of lumbar ribs.

870.3700b Prenatal developmental in nonrodents ( rabbit) 40752003 ( 1988) Unacceptable/ guideline F: 0, 5, 25, or 50 mg/ kg/ day Must be considered with MRID 00156546 Maternal NOAEL = 50 mg/ kg/ day LOAEL = not identified Developmental NOAEL = 50 mg/ kg/ day LOAEL = not identified Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 15 870.3800 Reproduction and fertility effects ( rat) 00156547 ( 1984) Unacceptable/ guideline 0, 70, 170, or 420 ppm P: 0, 3.5, 8.5, or 21 mg/ kg/ day Must be considered with MRID 00162176 a Parental/ Systemic NOAEL = 8.5 mg/ kg/ day LOAEL = 21 mg/ kg/ day based on decreased body weight and overall body weight gain, increased relative liver weights, and increased mortality in females. Reproductive NOAEL = not identified LOAEL = 3.5 mg/ kg/ day based on based on increased gestation length in P. Offspring NOAEL = 8.5 mg/ kg/ day LOAEL = 21 mg/ kg/ day based on decreased pup body weight, survival indices, and litter sizes and a slight increased incidence of hydronephrosis in F 1a pups.

870.3800 Reproduction and fertility effects ( rat) 00162176 ( 1986) 00156548 ( 1984) 40301602 ( 1987) Acceptable/ guideline with MRID 00156547 0, 30, 70, or 170 ppm P: 0, 1.5, 3.5, or 8.5 mg/ kg/ day Parental/ Systemic NOAEL = 8.5 mg/ kg/ day LOAEL = not established Reproductive NOAEL = 1.5 mg/ kg/ day LOAEL = 3.5 mg/ kg/ day based on based on increased gestation length in dams of the F 3a interval. Offspring NOAEL = 3.5 mg/ kg/ day LOAEL = 8.5 mg/ kg/ day based on decreased pup weights, survival indices, and litter sizes in both F 3 litters, reduced litter size in the F 1a litter, increased total litter mortality in the F 3a litter, and developmental effects in the F 1b and F 2b progeny.

870.4100a Chronic toxicity rodents NA; see 870.4300 NA 870.4100b Chronic toxicity nonrodents ( dog) 00149848 ( 1984) Acceptable/ guideline 0, 100, 300, or 1000 ppm M: 0, 3.33, 10.00, or 34.10 mg/ kg/ day F: 0, 3.27, 10.69, or 35.17 mg/ kg/ day NOAEL = Males: 10.00 mg/ kg/ day; Females: 10.69 mg/ kg/ day LOAEL = Males: 34.10 mg/ kg/ day; Females: 35.17 mg/ kg/ day based on increased alkaline phosphatase activity and a mild, macrocytic anemia in males, increased absolute and relative liver weights in both sexes, and on macroscopic findings in the liver of both sexes.

870.4200a Carcinogenicity ( rat) NA; see 870.4300 NA 870.4200b Carcinogenicity ( mouse) 00156544 ( 1984) Acceptable/ guideline 0, 100, 400, or 1600 ppm M: 0, 16.2, 67.4, or 296.1 mg/ kg/ day F: 0, 21.7, 86.1, or 362.2 mg/ kg/ day NOAEL = Males: 16.2 mg/ kg/ day; Females: 21.7 mg/ kg/ day LOAEL = Males: 67.4 mg/ kg/ day; Females: 86.1 mg/ kg/ day based on microscopic lesions of the liver. No evidence of carcinogenicity 870.4300 Combined Chronic/ oncogenicity ( rat) 00156545 ( 1984) 40301604 ( 1987) Acceptable/ guideline 0, 100, 400, or 1600 ppm M: 0, 3.5 3.7, 14.1 15.1, or 59.4 62.0 mg/ kg/ day F: 0, 4.5 4.6, 18.0 18.1, or 77.0 78.0 mg/ kg/ day NOAEL = Males: < 3.5 3.7 mg/ kg/ day; Females: < 4.5 4.6 mg/ kg/ day LOAEL = Males: 3.5 3.7 mg/ kg/ day; Females: 4.5 4.6 mg/ kg/ day based on liver toxicity ( eosinophilic foci in male rats and fatty vacuolation and inflammation and necrosis in female rats). No evidence of carcinogenicity.

870.5100 Bacterial reverse mutation 40494409 ( 1987) Acceptable seven concentrations ranging from 5 to 5000 : g/ plate Negative with or without S9 activation at 5000 : g/ plate and less.

870.5100 Bacterial reverse mutation 45502203 ( 1983) Acceptable concentrations ranging from 8 to 8000 : g/ plate Negative with or without S9 activation at 8000 : g/ plate and less.

870.5375 In vitro mammalian chromosome abberation ( CHL) 40494408 ( 1987, 1988) Acceptable 5 to 40 : g/ mL Negative with or without S9.

870.5395 In vitro mammalian cytogenetics ( mouse bone marrow) 00160620 ( 1986) Acceptable M& F: 160, 533 and 1600 mg/ kg ( single oral dose) Negative. Not clastogenic for the production of micronuclei in bone marrow polychromatic erythrocytes in mice at single oral doses up to 1600 mg/ kg. Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 16 870.5500 DNA damage/ repair REC assay 45502204 ( 1983) Unacceptable concentrations range from 24 to 24,000 mg/ disk Negative. No evidence of DNA damage up to 24,000 mg/ disk. Study is unacceptable because a metabolic activation system was not used.

870.5550 UDS in primary rat hepatocytes 45502205 ( 1984) Acceptable 12.5 to 30 : g/ mL Negative. No evidence of unscheduled DNA synthesis up to cytotoxic concentrations.

870.6200a Acute neurotoxicity screening battery 46202501 ( 2003) Acceptable M: 0, 25, 100, 400 mg/ kg/ day F: 0, 25, 100, 200 mg/ kg/ day NOAEL = 25 mg/ kg/ day LOAEL = 100 mg/ kg bw/ day, based on FOB findings ( neuromuscular impairment) and decreased locomotor activity 870.6200b Subchronic neurotoxicity screening battery 46202502 ( 2004) Unacceptable M: 0, 4.10, 40.9 or 117.3 mg/ kg/ day F: 0, 4.88, 47.8 or 133.3 mg/ kg/ day NOAEL = 117.3/ 133.3 ( M/ F) mg/ kg/ day LOAEL = not established Study is unacceptable because of lack of positive control data 870.6300 Developmental neurotoxicity NA NA 870.7485 Metabolism and pharmacokinetics ( rat) 40789101 ( 1988) Acceptable/ guideline with 41606201 and 41606202 M& F: 10 mg/ kg as single oral dose Following oral treatment of rats with [ phenyl U 14C] NF 114, no sex related differences were observed in absorption, metabolism, distribution or excretion. Maximum concentrations of radioactivity in plasma were attained within 1 hour of dosing in both sexes. Low levels of radioactivity were detectable in all tissue, organ, and blood samples. Radioactivity in urine accounted for 69.5 74.4% of the dose and feces accounted for 21.7 21.9% of the dose. Based on the metabolite profile, the metabolism in rats primarily involves oxidation to FM 8 1 and FA 1 5, followed by sulfation and glucuronidation.

870.7485 Metabolism and pharmacokinetics ( rat) 41606201 ( 1983) 41606202 ( 1984) Acceptable/ guideline with 40789101 M& F: 10 or 300 mg/ kg as single oral dose Following oral treatment of rats with [ phenyl U 14C] NF 114, approximately 93.8 100.6% of the administered dose was recovered. Urine was the major route of excretion. Low levels of radioactivity were detectable in all tissue, organ, and blood samples collected 2 days ( 10 mg/ kg group) or 4 days ( 300 mg/ kg group) post dose with tissue concentrations generally higher in males than females. The metabolite profile in the excreta was quantitatively and qualitatively similar between the sexes and dose groups. Based on the metabolite profile, the biotransformation of NF 114 in rats primarily involved oxidation of parent to FM 8 1 and FA 1 5, followed by conjugation yielding sulfate and glucuronic acid conjugates.

870.7600 Dermal penetration NA NA Special studies Hepatic enzyme induction 40830401 ( 1988) Acceptable/ nonguideline M& F: 0 or 200 mg/ kg/ day as oral dose for five consecutive days The study provides evidence that triflumizole induces hepatic microsomal enzymes when administered orally. However, no correlation between the increased enzyme activities and hepatic lesions observed following chronic administration was made since no histopathology was performed.

Summary of Toxicological Dose and Endpoints for Triflumizole for Use in Human Risk Assessment1. 17 Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF and Endpoint for Risk Assessment Study and Toxicological Effects Acute Dietary females 13 50 years of age NOAEL = 10 mg/ kg/ day UF = 100 Acute RfD = 0.1 mg/ kg/ day FQPA SF = 1X aPAD = acute RfD FQPA SF = 0.1 mg/ kg/ day Developmental Toxicity Study  Rat Developmental LOAEL = 35 mg/ kg/ day based on decreased numbers of viable fetuses, increased dead or resorbed fetuses, increased numbers of late resorptions, decreased fetal body weight, and increased incidences of cervical ribs.

Acute Dietary general U. S. population ( including infant and children) NOAEL = 25 mg/ kg/ day UF = 100 Acute RfD = 0.25 mg/ kg/ day FQPA SF = 1X aPAD = acute RfD FQPA SF = 0.03 mg/ kg/ day Acute Neurotoxicity Study  Rat LOAEL = 100 mg/ kg/ day based on FOB findings ( neuromuscular impairment) and decreased locomotor activity .

Chronic Dietary all populations NOAEL= 1.5 mg/ kg/ day UF = 100 Chronic RfD = 0.015 mg/ kg/ day FQPA SF = 1X cPAD = chronic RfD FQPA SF = 0.015 mg/ kg/ day Multi generation Reproduction Study  Rat Reproductive LOAEL = 3.5 mg/ kg/ day based on increased gestation length in dams of the F3a interval.

Short Term Oral ( 1 30 days)

( Residential) oral NOAEL= 8.5 mg/ kg/ day LOC for MOE = 100 ( Residential, includes the FQPA SF) Multi generation Reproduction Study  Rat LOAEL = 21 mg/ kg/ day, based on decreased body weight gain in pups during lactation.

Intermediate Term Oral ( 1 6 months)

( Residential) oral NOAEL= 8.5 mg/ kg/ day LOC for MOE = 100 ( Residential, includes the FQPA SF) Multi generation Reproduction Study  Rat LOAEL = 21 mg/ kg/ day, based on decreased body weight gain in pups during lactation and decreased body weight and body weight gain in parental animals.

Short Term Dermal ( 1 30 days)

( Occupational/ Residential) oral NOAEL= 8.5 mg/ kg/ day ( dermal absorption rate = 3.5%) LOC for MOE = 100 ( Occupational)

LOC for MOE = 100 ( Residential, includes the FQPA SF) Multi generation Reproduction Study  Rat LOAEL = 21 mg/ kg/ day, based on decreased body weight gain in pups during lactation.

Intermediate and Long Term Dermal ( 1 6 months and 6 month or longer)

( Occupational/ Residential) oral NOAEL= 1.5 mg/ kg/ day ( dermal absorption rate = 3.5%) LOC for MOE = 100 ( Occupational)

LOC for MOE = 100 ( Residential, includes the FQPA SF) Multi generation Reproduction Study  Rat LOAEL = 3.5 mg/ kg/ day based on increased gestation length in the dams of the F3a interval. Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF and Endpoint for Risk Assessment Study and Toxicological Effects 18 Short Term Inhalation ( 1 30 days)

( Occupational/ Residential) oral NOAEL= 8.5 mg/ kg/ day ( inhalation absorption rate = 100%) LOC for MOE = 100 ( Occupational)

LOC for MOE = 100 ( Residential, includes the FQPA SF) Multi generation Reproduction Study  Rat LOAEL = 21 mg/ kg/ day, based on decreased body weight gain in pups during lactation.

Intermediate and Long Term Inhalation ( 1 6 months and 6 month or longer)

( Occupational/ Residential) oral NOAEL= 1.5 mg/ kg/ day ( inhalation absorption rate = 100%) LOC for MOE = 100 ( Occupational)

LOC for MOE = 100 ( Residential, includes the FQPA SF) Multi generation Reproduction Study  Rat LOAEL = 3.5 mg/ kg/ day based on increased gestation length in the dams of the F3a interval.

Cancer ( oral, dermal, inhalation) evidence for noncarcinogenicity for humans Not applicable Combined Chronic Toxicity/ Carcinogenicity Study  Rat Carcinogenicity Study  Mouse No evidence of carcinogenicity in rats and mice.

1 UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose ( a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of concern. 19 Attachment 2. Summary of Proposed Use Pattern.

Crop Site broccoli, cilantro, collards, dandelion, kale, kohlrabi, mustard greens, Napa cabbage, parsley, Swiss chard in Texas Pest powdery mildew A. I. triflumizole [ 1[ 1(( 4 chloro 2( trifluoromethyl) phenyl) imino)  2 propoxyethyl] 1Himidazole

Formulation Procure ® 50 WS Fungicide, EPA Reg. No. 400  431, 50 % a. i. powder.

Application Method groundboom, aerial Application Rate 0.1875 lb a. i./ A Application Number not specified Application Maximum 0.5 lb a. i./ A/ yr.

Application Interval 10  14 days ( do not apply more than 2 sequential applications)

PHI 1 days Maximum acres treated 3,000 possible Maximum a. i. used 1,125 lb active ingredient if all acres are treated 2 times at the maximum rate Manufacturer Gowan Company Rotational Crop Restrictions Not specified Restrictions ° No more than two sequential applications without at least one intervening application of an alternative registered fungicide for powdery mildew control is allowed. ° Applications through any type of irrigation system is prohibited.


[Federal Register Volume 81, Number 154 (Wednesday, August 10, 2016)]
[Notices]
[Pages 52958-52959]
[FR Doc No: 2016-18199]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Applications for Special Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of applications for special permits.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR part 107,
subpart B), notice is hereby given that the Office of Hazardous
Materials Safety has received the application described herein. Each
mode of transportation for which a particular special permit is
requested is indicated by a number in the ``Nature of Application''
portion of the table below as follows: 1--Motor vehicle, 2--Rail
freight, 3--Cargo vessel, 4--Cargo aircraft only, 5--Passenger-carrying
aircraft.

DATES: Comments must be received on or before September 9, 2016.

ADDRESSES: Record Center, Pipeline and Hazardous Materials Safety
Administration U.S. Department of Transportation Washington, DC 20590.
Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Ryan Paquet, Director, Office of
Hazardous Materials Approvals and Permits Division, Pipeline and
Hazardous Materials Safety Administration, U.S. Department of
Transportation, East Building, PHH-30, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Copies of the applications are available for
inspection in the Records Center, East Building, PHH-30, 1200 New
Jersey Avenue Southeast, Washington, DC or at http://regulations.gov.
    This notice of receipt of applications for special permit is
published in accordance with Part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on July 19, 2016.
Donald Burger,
Chief, Office of the Special Permits and Approvals.

----------------------------------------------------------------------------------------------------------------
                                                                         Regulation(s)     Nature of the special
    Application No.             Docket No.             Applicant           affected           permits thereof
----------------------------------------------------------------------------------------------------------------
                                              SPECIAL PERMITS DATA
----------------------------------------------------------------------------------------------------------------
20260-N................  .......................  ROGERS              173.27(b)(2),       To authorize the
                                                   HELICOPTERS, INC.   172.101(j),         transportation in
                                                                       172.200(a),         commerce of certain
                                                                       172.200,            hazardous materials
                                                                       172.204(c)(3),      by 14 CFR part 133
                                                                       172.400(b),         Rotorcraft External
                                                                       172.400a(a),        Load Operations
                                                                       172.300(a),         transporting
                                                                       172.300,            hazardous materials
                                                                       172.301(c),         attached to or
                                                                       175.75(b),          suspended from an
                                                                       175.75(c),          aircraft, in remote
                                                                       178.1010(a)(1).     areas of the US only,
                                                                                without being subject
                                                                                to hazard
                                                                                communication
                                                                                requirements,
                                                                                quantity limitations,
                                                                                and certain loading
                                                                                and stowage
                                                                                requirements. (mode
                                                                                3).
20262-N................  .......................  SHIJIAZHUANG ENRIC  173.302(a),         To authorize the
                                                   GAS EQUIPMENT       173.304(a).         transportation of
                                                   CO., LTD.                               certain hazardous
                                                                                materials in non-DOT
                                                                                specification fiber
                                                                                reinforced composite
                                                                                cylinders. (mode 1).
20265-N................  .......................  HYPERCOMP           178.71(l)(ii).....  To authorize the
                                                   ENGINEERING, INC.                       manufacture, mark,
                                                                                sale, and use of non-
                                                                                DOT specification
                                                                                composite overwrapped
                                                                                pressure vessels for
                                                                                the transportation of
                                                                                certain hazardous
                                                                                materials. (modes 1,
                                                                                2, 3, 4).

20266-N................  .......................  ZHEJIANG TIANTAI    173.304(a),         To authorize the
                                                   ZHANTU AUTOMOBILE   172.304(d).         manufacture, mark,
                                                   SUPPLIES CO., LTD.                      sale and use of a non-
                                                                                refillable, non-DOT
                                                                                specification inside
                                                                                metal container
                                                                                conforming to all
                                                                                regulations
                                                                                applicable to a DOT
                                                                                specification 2Q for
                                                                                the transportation in
                                                                                commerce of the
                                                                                materials authorized
                                                                                by this special
                                                                                permit. (modes, 1, 2,
                                                                                3, 4).
20271-N................  .......................  BALL AEROSPACE &    173.24(b)(1)......  To authorize the
                                                   TECHNOLOGIES                            transportation in
                                                   CORPORATION.                            commerce of DOT
                                                                                specification
                                                                                cylinders that have
                                                                                an identifiable
                                                                                release of hazardous
                                                                                materials during
                                                                                transportation. (mode
                                                                                1).
20272-N................  .......................  BALL AEROSPACE &    173.24(b)(1),       To authorize the
                                                   TECHNOLOGIES        173.185(a).         transportation in
                                                   CORPORATION.                            commerce of low
                                                                                production lithium
                                                                                ion batteries
                                                                                contained in
                                                                                equipment via highway
                                                                                transportation. (mode
                                                                                1).
20273-N................  .......................  ATK LAUNCH SYSTEMS  173.56(a), 172.320  To authorize the one-
                                                   INC.                                    time, one-way
                                                                                transportation of
                                                                                blasting caps that
                                                                                have not been issued
                                                                                an EX approval. (mode
                                                                                1).
20274-N................  .......................  SDV (USA) INC.....  172.101(j),         To authorize the
                                                                       172.300, 172.400,   transportation in
                                                                       173.21, 173.301,    commerce of certain
                                                                       173.302(a),         non-DOT specification
                                                                       173.304(a).         containers containing
                                                                                certain Division 2.1,
                                                                                2.2, 2.3 liquefied
                                                                                and compressed gases
                                                                                and other hazardous
                                                                                materials for use in
                                                                                specialty cooling
                                                                                applications such as
                                                                                satellites and
                                                                                military aircraft.
                                                                                (modes 1, 4).
20275-N................  .......................  ST. LOUIS           172.600, 172.200,   To authorize the
                                                   HELICOPTER LLC.     172.400, 172.300,   transportation in
                                                                       175.1(a).           commerce in the U.S.
                                                                                only of certain
                                                                                hazardous materials
                                                                                by 14 CFR Part 133
                                                                                Rotorcraft External
                                                                                Load Operations
                                                                                transporting
                                                                                hazardous materials
                                                                                attached to or
                                                                                suspended from an
                                                                                aircraft and 14 CFR
                                                                                part 135 operations
                                                                                transporting
                                                                                hazardous materials
                                                                                on board an aircraft.
                                                                                (mode 4).
20277-N................  .......................  VAN HOOL NV.......  178.274(b),         To authorize the
                                                                       178.277(b).         manufacture, mark,
                                                                                sale, and use of
                                                                                portable tanks
                                                                                meeting the
                                                                                requirements of the
                                                                                latest edition of the
                                                                                Section VIII of the
                                                                                ASME Code. (mode 1,
                                                                                2, 3).
20282-N................  .......................  U.S. WATER ENERGY   173.35(f)(1)......  To authorize the
                                                   SERVICES, INC.                          transportation in
                                                                                commerce of a damaged
                                                                                IBC with corrosive
                                                                                residue on the
                                                                                outside of the
                                                                                container. (mode 1).
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2016-18199 Filed 8-9-16; 8:45 am]
 BILLING CODE 4909-60-M


[Federal Register: February 21, 2007 (Volume 72, Number 34)]
[Notices]
[Page 7872-7873]
[DOCID:fr21fe07-28]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0137; FRL-8116-5]

Pesticide Program Dialogue Committee: Azinphos-methyl Transition
Issues Work Group, Spray Drift Work Group, and Registration Review
Implementation Work Group; Notice of Public Meetings

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA's Pesticide Program Dialogue Committee (PPDC) will hold
public meetings for three PPDC Work Groups: the Azinphos-methyl (AZM)
Transition Issues Work Group, Spray Drift Work Group, and Registration
Review Implementation Work Group. The public meetings will be held
March 6-8, 2007. Agendas for these meetings are being developed and
will be posted on EPA's website. In light of the recent EPA decision to
phase-out the remaining uses of the organophosphate AZM over the next
few years, the AZM Transition Issues Work Group is being created to
help advise EPA and USDA on the AZM transition planning and
implementation. The Spray Drift Work Group, co-chaired by EPA Offices
of Water and Pesticide Programs, is improving understanding of the
perspectives of all stakeholders regarding spray drift and will provide
recommendations on ways to mitigate spray drift. The Registration
Review Implementation Work Group is developing recommendations for the
Registration Review initial docket opening process.

DATES: The AZM Transition Issues Work Group meeting will be held on
March 6, 2007 from 10 a.m. to 6 p.m. The Spray Drift Work Group meeting
will be held on March 7, 2007 from 9 a.m. to 5 p.m. and on March 8,
2007 from 8:45 a.m. to 12 p.m. The Registration Review Implementation
Work Group meeting will be held on March 8, 2007 from 8:30 a.m. to 4
p.m.
    To request accommodation of a disability, please contact the person
listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10
days prior to the meeting, to give EPA as much time as possible to
process your request.

ADDRESSES: The meetings will all be held at EPA's offices at 2777 South
Crystal Dr., First Floor Conference Center. Arlington, VA 22202, except
the second day of the Spray Drift Work Group meeting will be in room S-
12100 of this same building.

FOR FURTHER INFORMATION CONTACT:  For AZM Transition Issues Workgroup
questions, contact: Linda Murray; Biological and Economic Analysis
Division (7503P); Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>For Spray Drift Work Group
questions, contact: Pat Cimino, Biological and Economic Analysis
Division (7503P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number: (703) 308-809;
email address<EMAIL_ADDRESS>For Registration Review
Implementation Work Group questions, contact: Kennan Garvey, Special
Review and Reregistration Division (7508P), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the
persons listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPPT-2007-0137 Publicly
accessible docket materials are available either in the electronic
docket at http://www.regulations.gov, or, available in hard copy, at

the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm.
S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive
Arlington, VA. The hours of operation of this Docket Facility are from
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The Docket telephone number is<PHONE_NUMBER>.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

II. Background

    The Office of Pesticide Programs is entrusted with the
responsibility of ensuring the safety of the American food supply,
protection and education of those who apply or are exposed to
pesticides occupationally or through use of products, and the general
protection of the environment and special ecosystems from potential
risks posed by pesticides.
    Because of EPA's decision to phase-out the remaining uses of the
organophosphate AZM over the next few years, the AZM Transition Issues
Work Group is being created to help advise EPA and USDA on the AZM
transition planning and implementation

and is holding a meeting on March 6, 2007. The Spray Drift Work Group,
co-chaired by EPA Offices of Water and Pesticide Programs, is improving
understanding of the perspectives of all stakeholders regarding spray
drift and will provide recommendations on ways to mitigate spray drift
is chairing a meeting on March 7 and 8, 2007. The Registration Review
Implementation Work Group which is developing recommendations for the
Registration Review initial docket opening process will chair a meeting
on March 8, 2007. Future meetings will be announced on the work group's
Web sites (see: Active Workgroups menu at: http://www.epa.gov/pesticides/ppdc/
).

    PPDC was established under the Federal Advisory Committee Act
(FACA), Public Law 92-463, in September 1995 for a 2-year term and has
been renewed every 2 years since that time. PPDC provides advice and
recommendations to OPP on a broad range of pesticide regulatory,
policy, and program implementation issues that are associated with
evaluating and reducing risks from use of pesticides. The following
sectors are represented on the PPDC: pesticide industry and trade
associations; environmental/public interest and consumer groups; farm
worker organizations; pesticide user, grower, and commodity groups;
federal/state/local/ and tribal governments; the general public;
academia; and public health organizations.
    Copies of the PPDC charter are filed with appropriate committees of
Congress, the Library of Congress, and are available upon request.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated Febrary 12, 2007.
James Jones,
Director, Office of Pesticide Programs.
[FR Doc. E7-2871 Filed 2-20-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: August 19, 2009 (Volume 74, Number 159)]
[Rules and Regulations]
[Page 41790-41791]
[DOCID:fr19au09-3]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2009-0689]

Drawbridge Operation Regulation; Gulf Intracoastal Waterway,
Sargent, TX

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Eighth Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
FM 457 pontoon drawbridge across the Gulf Intracoastal Waterway, mile
418.0, west of Harvey Locks, near Sargent,

Matagorda County, Texas. The deviation is necessary for continued
maintenance of the bridge. This deviation allows the bridge to remain
closed to navigation.

DATES: This deviation is effective from 6 a.m. through 5 p.m. on
September 2, 2009.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2009-0689 and are available online
by going to http://www.regulations.gov, inserting USCG-2009-0689 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 rule,
call or e-mail Lindsey Middleton, Bridge Administration Branch, Coast
Guard; telephone<PHONE_NUMBER>, 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: The Texas Department of Transportation has
requested a temporary deviation for the FM 457 pontoon drawbridge
across the Gulf Intracoastal Waterway, mile 418.0, west of Harvey
Locks, near Sargent, Matagorda County, Texas. They requested the
temporary deviation for scheduled maintenance on the bridge. Currently,
according to 33 CFR 117.5, the drawbridge opens on signal for the
passage of vessels. The temporary deviation would allow the bridge to
remain closed to navigation from 9 a.m. until 6 p.m. on Wednesday,
September 2, 2009. The bridge has no vertical clearance in the closed-
to-navigation position and has unlimited clearance in the open-to-
navigation position. Navigation on the waterway consists of tugs with
tows, fishing vessels, sailing vessels, and other recreational craft.
This work is essential for the continued operation of the draw span.
This request has been coordinated with waterway user groups and the
local Coast Guard office.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: August 9, 2009.
David M. Frank,
Bridge Administrator.
[FR Doc. E9-19823 Filed 8-18-09; 8:45 am]

BILLING CODE 4910-15-P