[Federal Register Volume 86, Number 7 (Tuesday, January 12, 2021)]
[Notices]
[Pages 2473-2476]
[FR Doc No: 2021-00349]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90863; File No. SR-CboeBZX-2021-004]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend Its
Fee Schedule Relating to LMM Financial Incentives

January 6, 2021.

    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 January 4, 2021, Cboe BZX Exchange, Inc. (the ``Exchange'' or
``BZX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    Cboe BZX Exchange, Inc. (the ``Exchange'' or ``BZX'') is filing
with the Securities and Exchange Commission (``Commission'') a proposed
rule change to amend the fee schedule. The text of the proposed rule
change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/bzx/), at the Exchange's Office of the Secretary, and at
the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend the fee schedule applicable to its
equities trading platform (``BZX Equities'') to update the Standard
Rates and Enhanced Rates provided under the Lead Market Maker (``LMM'')
Liquidity Provision Rates, effective January 4, 2021. The Exchange
believes the proposed changes will better incentivize LMMs to meet the
Standard and Enhanced Minimum Performance Standards where their average
aggregate daily auction volume is 1,000,000 shares or less.
    The Exchange first notes that its listing business operates in a
highly-competitive market in which market participants, which includes
issuers of securities, LMMs, and other liquidity providers, can readily
transfer their listings, opt not to participate, or direct order flow
to competing venues if they deem fee levels, liquidity provision
incentive programs, or any other factor at a particular venue to be
insufficient or excessive. The proposed rule changes reflect a
competitive pricing structure designed to incentivize market
participants to participate as LMMs in the Exchange's LMM Program,
which the Exchange believes will enhance market quality in all
securities listed on the Exchange and encourage issuers to list new
products and transfer existing products to the Exchange.
    The Exchange currently offers daily incentives for LMMs in Exchange
Traded Products (``ETPs'') listed on the Exchange for which the LMM
meets certain Minimum Performance Standards.\3\ Such daily incentives
are

determined based on the number of Cboe-listed ETPs for which the LMM
meets such Minimum Performance Standards and the average auction volume
across such securities. Generally speaking, the more LMM Securities \4\
for which the LMM meets the Minimum Performance Standards and the
higher the auction volume across those ETPs, the greater the total
daily payment to the LMM. Such daily incentive Standard Rates are
structured as follows:
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    \3\ As defined in Rule 11.8(e)(1)(E), the term ``Minimum
Performance Standards'' means a set of standards applicable to an
LMM that may be determined from time to time by the Exchange. Such
standards will vary between LMM Securities depending on the price,
liquidity, and volatility of the LMM Security in which the LMM is
registered. The performance measurements will include: (A) Percent
of time at the NBBO; (B) percent of executions better than the NBBO;
(C) average displayed size; and (D) average quoted spread. For
additional detail, see Original LMM Filing.
    \4\ As defined in Rule 11.8(e)(1)(D), the term ``LMM Security''
means an ETP that has an LMM.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Average aggregate daily auction volume in LMM Securities
                                                          ----------------------------------------------------------------------------------------------
                                                                                3,000,001
                                                             0-10,000      10,001-        100,001-         500,001-          1,000,001-       or greater
---------------------------------------------------------------------------100,000---------500,000---------1,000,000----------3,000,000-----------------
Daily Incentive for each Qualified Security 1-5..........          $10           $25             $40              $50               $150            $200
Daily Incentive for each Qualified Security 6-25.........           10            25              25               30                100             150
Daily Incentive for each Qualified Security 26-50........           10            10              20               25                 75             100
Daily Incentive for each Qualified Security 51-100.......           10            10              15               20                 50              75
Daily Incentive for each Qualified Security Greater Than            10            10              15               15                 25              50
 100.....................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    By way of example, if an LMM has 30 LMM Securities, each of which
is a Qualified ETP,\5\ 10 of which each have an average daily auction
volume of 5,000 shares (combined between the opening and closing
auction), 10 of which each have an average daily auction volume of
50,000 shares (combined between the opening and closing auction), and
10 of which each have an average daily auction volume of 200,000 shares
(combined between the opening and closing auction), then the LMM would
fall into the fifth column (10 * 5,000 + 10 * 50,000 + 10 * 200,000 =
2,550,000 average aggregate daily auction volume). As such, the LMM
would receive $150 each for five Qualified ETPs, $100 each for
Qualified ETPs 6-25, and $75 each for Qualified ETPs 26-30. This would
result in a daily payment of ($150 * 5) + ($100 * 20) + ($75 * 5) =
$3,125 to the LMM.
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    \5\ As provided in footnote 14 of the Fee Schedule, a
``Qualified ETP'' is an ETP for which an LMM is a Qualified LMM.
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    LMMs that meet a more stringent set of standards also receive
enhanced daily incentives (i.e., the Enhanced Rates), as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Average aggregate daily auction volume in LMM Securities
                                                          ----------------------------------------------------------------------------------------------
                                                                                3,000,001
                                                             0-10,000      10,001-        100,001-         500,001-          1,000,001-       or greater
---------------------------------------------------------------------------100,000---------500,000---------1,000,000----------3,000,000-----------------
Daily Incentive for each Enhanced Security 1-5...........        $2.50         $6.25             $10           $12.50             $37.50             $50
Daily Incentive for each Enhanced Security 6-25..........         2.50          6.25            6.25             7.50                 25           37.50
Daily Incentive for each Enhanced Security 26-50.........         2.50          2.50               5             6.25              18.75              25
Daily Incentive for each Enhanced Security 51-100........         2.50          2.50            3.75                5              12.50           18.75
Daily Incentive for each Enhanced Security Greater Than           2.50          2.50            3.75             3.75               6.25           12.50
 100.....................................................
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    Using the same example as above, where the LMM has 30 LMM
Securities, 10 of which are Enhanced ETPs, which have 2,550,000 shares
of average aggregate daily auction volume in LMM Securities, the issuer
would fall into the fifth column. As such, the LMM would receive an
additional $37.50 for each of its first five Enhanced ETPs and an
additional $25 each for Enhanced ETPs 6-10. This would result in an
additional daily payment of ($37.50 * 5) + ($25 * 5) = $312.50 to the
LMM.
Proposed Changes
    The Exchange proposes to amend the Standard Rates and Enhanced
Rates discussed above. First, the Exchange proposes to eliminate the
sixth column of both the Standard Rates and Enhanced Rates so that
average aggregate daily auction volume of 1,000,001 shares or more is
considered the highest average aggregate daily auction volume column.
    Second, the Exchange proposes to reduce the Standard Rates payments
for average aggregate daily auction volume of 1,000,001 shares or more
for each row of Qualified Security ranges. Specifically, the Exchange
proposes to reduce the payments in the fifth column as follows: $100
Daily Incentive for each Qualified Security 1-5, $70 Daily Incentive
for each Qualified Security 6-25, $50 Daily Incentive for each
Qualified Security 26-50, $25 Daily Incentive for each Qualified
Security 51-100, and $20 Daily Incentive for each Qualified Security
greater than 100.
    For instance, using the same example as above, where the LMM has 30
LMM Securities, 10 of which each have an average daily auction volume
of 5,000 shares, 10 of which each have an average daily auction volume
of 50,000 shares, and 10 of which each have an average daily auction
volume of 200,000 shares, then the LMM would fall into the fifth column
(10 * 5,000 + 10 * 50,000 + 10 * 200,000 = 2,550,000 average aggregate
daily auction volume). As such, under the proposed Standard Rates the
LMM would receive $100 each for Qualified ETPs 1-5, $70 each for
Qualified ETPs 6-25, and $50 each for Qualified ETPs 26-30. This would
result in a daily payment of ($100 * 5) + ($70 * 20) + ($50 * 5) =
$2,150 to the LMM.
    Third, the Exchange proposes to decrease the Enhanced Rates
payments for securities with average aggregate daily auction volume
over 1,000,000 shares and increase the Enhanced Rates payments for
securities with average aggregate daily auction volume of 1,000,000
shares or lower. Specifically, the Exchange proposes the following
Enhanced Rates:

----------------------------------------------------------------------------------------------------------------
                                                Average aggregate daily auction volume in LMM Securities
                                      --------------------------------------------------------------------------
                                                                                1,000,001
                                         0-10,000      10,001-        100,001-         500,001-       or greater
-------------------------------------------------------100,000---------500,000---------1,000,000----------------
Daily Incentive for each Enhanced               $3         $7.50             $12              $15            $30
 Security 1-5........................
Daily Incentive for each Enhanced                3          7.50            7.50                9             21
 Security 6-25.......................
Daily Incentive for each Enhanced                3             3               6             7.50             15
 Security 26-50......................
Daily Incentive for each Enhanced                3             3            4.50                6           7.50
 Security 51-100.....................
Daily Incentive for each Enhanced                3             3            4.50             4.50              6
 Security Greater Than 100...........
----------------------------------------------------------------------------------------------------------------

    The proposed changes are designed to encourage LMMs with average
aggregate daily auction volume of 1,000,000 shares or less to meet the
Standard and Enhanced Minimum Performance Standards. The proposed
changes would decrease payments in LMM securities with average
aggregate daily auction volume of 1,000,001 shares or greater. Using
the same example above, where the LMM has 30 LMM Securities, 10 of
which are Enhanced ETPs, which have 2,550,000 shares of average
aggregate daily auction volume in LMM Securities, the issuer would fall
into the fifth column. As such, the LMM would receive an additional $30
for each of its first five Enhanced ETPs and an additional $21 each for
Enhanced ETPs 6-10. This would result in an additional daily payment of
($30 * 5) + ($21 * 5) = $255 to the LMM as opposed to the $312.50 it
would receive under the current Enhanced Rates.
    However, the proposed Enhanced Rates are also designed to increase
payments in LMM Securities with 1,000,000 or less average aggregate
daily auction volume. For example, if an LMM has 30 LMM Securities,
each of which is a Qualified ETP, 10 of which each have an average
daily auction volume of 500 shares, 10 of which each have an average
daily auction volume of 10,000 shares, and 10 of which each have an
average daily auction volume of 20,000 shares, then the LMM would fall
into the third column (10 * 500 + 10 * 10,000 + 10 * 20,000 = 305,000
average aggregate daily auction volume). As such, the LMM would receive
$12 each for Qualified ETPs 1-5, $7.50 each for Qualified ETPs 6-25,
and $6 each for Qualified ETPs 26-30. This would result in a daily
payment of ($12 * 5) + ($7.50 * 20) + ($6 * 5) = $240 to the LMM. Under
the current Enhanced Rates, the LMM would receive a daily payment of
($10 * 5) + (6.25 * 20) + (5 * 5) = $200.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder applicable to the
Exchange and, in particular, the requirements of Section 6(b) of the
Act.\6\ Specifically, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \7\ requirements that the rules of
an exchange be designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \8\ as it is designed to provide
for the equitable allocation of reasonable dues, fees and other charges
among its Members and other persons using its facilities. The Exchange
also notes that its listing business operates in a highly-competitive
market in which market participants, which includes issuers of
securities, LMMs, and other liquidity providers, can readily transfer
their listings, opt not to participate, or direct order flow to
competing venues if they deem fee levels, liquidity provision incentive
programs, or any other factor at a particular venue to be insufficient
or excessive. The proposed rule changes reflect a competitive pricing
structure designed to incentivize market participants to participate as
LMMs in the Exchange's LMM Program, which the Exchange believes will
enhance market quality in all securities listed on the Exchange and
encourage issuers to list new products and transfer existing products
to the Exchange.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
    \8\ Id.
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    The Exchange believes that the proposed changes to the Standard
Rates and Enhanced Rates of the LMM Liquidity Provision Rates are
consistent with the Act and represent a reasonable, equitable, and not
unfairly discriminatory means to incentivize liquidity provision in
ETPs listed on the Exchange. The marketplace for listings is extremely
competitive and there are several other national securities exchanges
that offer ETP listings. Transfers between listing venues occur
frequently for numerous reasons, including market quality. This
proposal is intended to help the Exchange compete as an ETP listing
venue. Specifically, the Exchange believes that the proposal is
reasonable because it believes that the proposed amendments will
encourage LMMs with lower aggregate auction volumes to meet the
Enhanced Minimum Performance Standards. The Exchange believes that
incentivizing such LMMs to meet the Enhanced Minimum Performance
Standards will increase market quality in lower volume BZX-listed ETPs.
To the extent that market quality in any BZX-listed ETP is negatively
impacted, competitive forces would generally dictate that the primary
listing venue enhance their own liquidity provision programs or that
the security would transfer to a different primary listing venue.
    The Exchange believes that the proposal represents an equitable
allocation of payments and is not unfairly discriminatory because,
while the proposed payments apply only to LMMs, such LMMs must meet
rigorous Minimum Performance Standards in order to receive the
payments. Where an LMM does not meet the Minimum Performance Standards
for the Standard and Enhanced Rates, they will not receive the
applicable payment. Further, registration as an LMM is available
equally to all Members and allocation of listed ETPs between LMMs is
governed by Exchange Rule 11.8(e)(2). If an LMM does not meet the
Minimum Performance Standards for three out of the past four months,
the LMM is subject to forfeiture of LMM status for that LMM Security,
at the Exchange's discretion.
    Further, the proposed daily payment amounts would continue to be
based specifically on the Exchange's revenue model. For ETPs with
greater auction volume, the Exchange generally makes more money and,
thus, is able to offer LMMs with LMM Securities that have higher
average aggregate daily auction

volume higher payments. Specifically, the payment per Qualified ETP
(and thus the total payment to an LMM) generally goes up as the CADV
moves from left to right because as the average aggregate daily auction
volume in LMM Securities increases, the Exchange will generate
additional revenue and can thus support increased payments to LMMs.
Similarly, the payments per Qualified ETP generally go down as the
number of Qualified ETPs goes up in order to ensure that the daily
incentive payments do not exceed the Exchange's revenue for that LMM's
LMM Securities while still providing incentives for LMMs to take on
additional ETPs. While the proposed changes would reduce payments to
LMMs with higher average aggregate daily auction volume, such payments
would still be higher than the proposed increased payments for LMMs
with lower average aggregate daily auction volume. As such, the
Exchange believes that the proposal is an equitable allocation of
payments and is not unfairly discriminatory.

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

    The Exchange does not believe that the proposed rule changes will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange does not believe
the proposed change burdens competition, but rather, enhances
competition as it is intended to increase the competitiveness of BZX
both among Members by incentivizing Members to become LMMs in BZX-
listed ETPs and as a listing venue by enhancing market quality in BZX-
listed ETPs. The marketplace for listings is extremely competitive and
there are several other national securities exchanges that offer ETP
listings. Transfers between listing venues occur frequently for
numerous reasons, including market quality. This proposal is intended
to help the Exchange compete as an ETP listing venue. Accordingly, the
Exchange does not believe that the proposed change will impair the
ability of issuers, LMMs, or competing ETP listing venues to maintain
their competitive standing. The Exchange also notes that the proposed
change is intended to enhance market quality in BZX-listed ETPs, to the
benefit of all investors in BZX-listed ETPs. The Exchange does not
believe the proposed amendment would burden intra-market competition as
it would be available to all Members uniformly. Registration as an LMM
is available equally to all Members and allocation of listed ETPs
between LMMs is governed by Exchange Rule 11.8(e)(2). Further, if an
LMM does not meet the Minimum Performance Standards for three out of
the past four months, the LMM is subject to forfeiture of LMM status
for that LMM Security, at the Exchange's discretion.

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

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \9\ and paragraph (f) of Rule 19b-4
thereunder.\10\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act. If
the Commission takes such action, the Commission will institute
proceedings to determine whether the proposed rule change should be
approved or disapproved.
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CboeBZX-2021-004 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-CboeBZX-2021-004. 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-CboeBZX-2021-004 and should be submitted
on or before February 2, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-00349 Filed 1-11-21; 8:45 am]
BILLING CODE 8011-01-P


  SEQ CHAPTER \h \r 1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:  	November 2, 2007

SUBJECT:	Ethalfluralin: Acute, Chronic Non-Cancer, and Chronic Cancer Dietary Risk Assessments for the Section 3 Registration Actions for Dill and Potato.

PC Code:		113101

Decision Number:	336469

DP Barcode Number:	D333868

REVIEWER:	Christina Swartz, Chemist

Registration Action Branch 2

		Health Effects Division (7509P)

THROUGH:	Susan Stanton

		Mohsen Sahafeyan

		Dietary Exposure Science Advisory Council

and

Richard A. Loranger, PhD, Branch Senior Scientist

Registration Action Branch 2

Health Effects Division (7509P)

TO:		S. Brothers

assessments were conducted using the Dietary Exposure Evaluation Model (DEEM-FCID™, Version 2.14), which uses food consumption data from the USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analyses were performed to support the Section 3 requests for the establishment of permanent tolerances for residues of the herbicide ethalfluralin, [N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-4-(trifluoromethyl)-benzena mine], in dill and potato.

Acute Dietary Exposure Results and Characterization

An acute dietary endpoint (i.e., single dose endpoint) for risk assessment was not identified in the toxicity database for the general US population.  For females 13-49, the acute assessment was somewhat refined with the use of anticipated residues for existing commodities.  However, the risk estimate is considered conservative because anticipated residues were only used for blended commodities, but tolerance-level and proposed tolerance-level residues were used for all others.  In addition, an assumption of 100% crop treated (100 %CT) was used.  A modeled estimated drinking water concentration (EDWC) of 0.011 ppm was derived from surface water estimates, and was included directly in the dietary analysis.  The acute dietary exposure of 0.00061 mg/kg/day ethalfluralin at the 95th percentile of exposure is equivalent to <1 % of the acute population adjusted dose (aPAD) and is below HED’s level of concern (LOC) for females 13-49 years.

Chronic Dietary Exposure Results and Characterization

The chronic non-cancer dietary analysis for ethalfluralin is a conservative estimate of dietary exposure to ethalfluralin.  Although some refinements were used (AR values for many existing commodities), the use of existing (for some commodities) and proposed tolerance levels and the assumption of 100% crop treated result in protective estimates of chronic dietary exposure.  The risk estimate for chronic dietary exposure to ethalfluralin for the U.S. population is 0.00006 mg/kg/day and is equivalent to <1% of the cPAD, which is not of concern for chronic dietary risk.  The exposure estimate for the most highly exposed population subgroup, children 1 to 2 years, is 0.00013 mg/kg/day, and is equivalent to <1% of the cPAD, which is also not of concern.

Cancer Dietary Exposure Results and Characterization

Ethalfluralin is classified as a possible human carcinogen with a cancer potency factor (Q1*) of 8.9 x 10-2 (mg/kg/day)-1.  The ethalfluralin chronic cancer dietary analysis was refined with anticipated residues for soybean, watermelon and drinking water derived from monitoring data generated by USDA’s Pesticide Data Program; the calculated limit of detection (LOD) for potato commodities; the ARs used in the acute/chronic dietary assessments (blended commodities); and either proposed or existing tolerance-level values for the remaining commodities.  No adjustments were made for the % of crop treated, i.e., 100 %CT was assumed.  The risk estimate for chronic cancer dietary (food + water) exposure to ethalfluralin for the U.S. population yields a cancer risk estimate of 2 x 10-6.  EPA generally considers cancer risks of 10-6 or less to be below the level of concern.  The precision which can be assumed for cancer risk estimates is best described by rounding to the nearest integral order of magnitude on the log scale; for example, risks falling between 3.16 x 10-7 and 3.16 x 10-6 are expressed as 10-6.  Considering the precision with which cancer hazard can be estimated and the rounding procedure described above, cancer risk should generally not be assumed to exceed the benchmark level of concern of 10-6 until the calculated risk exceeds approximately 3 x 10-6.  Since the calculated cancer risk for ethalfluralin falls below this level, estimated cancer risk is considered to be below the level of concern.

I.	Introduction

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

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

The most recent dietary risk assessment for ethalfluralin was conducted by J. Redden (7/29/02, DP Num: 283742).

II.	Residue Information

Current ethalfluralin tolerances, summarized in Table 1, are published in 40 CFR 180.416.  Also summarized in Table 1 are the anticipated residue (AR) values used in the current dietary exposure assessments; the rationale for the AR values is explained in this section.  The proposed tolerance of 0.05 ppm was used for dill and potato in the acute and non-cancer chronic analyses; however, for the cancer analysis, the calculated limit of detection (LOD) of 0.016 ppm was used for residues in potatoes (DP Barcodes: D306146, D306147, D333867, J. R. Tomerlin, 9/4/07).

Table 1.  Ethalfluralin, Tolerances and Anticipated Residue Values Used in the Dietary Analysis

Commodity	180.416 Tolerance

(ppm)	Anticipated Residue Value (Acute/Chronic, ppm)	Anticipated Residue Value

(Cancer, ppm)

Bean, dry, seed	0.05	0.01	0.01

Canola, seed	0.05	0.05	0.05

Dill	--	0.05	0.05

Peanut	0.05	0.01	0.01

Pea, dry, seed	0.05	0.01	0.01

Potato	--	0.05	0.016

Safflower, seed	0.05	0.05	0.05

Soybean	0.05	0.01	0.0005

Sunflower, seed	0.05	0.01	0.01

Vegetable, cucurbit, group 9, Except watermelon	0.05	0.01	0.01

Watermelon	0.05	0.01	0.0055

The somewhat refined acute and chronic non-cancer dietary analyses for ethalfluralin are conservative estimates of dietary exposure that used AR values and an assumption of 100%CT.  According to the ethalfluralin Registration Eligibility Decision Document (RED), residues from field trials were below the LOD of 0.01 ppm for dry bean, the cucurbit vegetable group, peanuts, dry peas, soybeans, and sunflower seed; therefore, the acute and chronic non-cancer dietary risk assessment used AR values equivalent to the LOD for these commodities, rather than the tolerance-level value.  In the acute and chronic non-cancer dietary risk assessments, tolerance level residues were assumed for all other food commodities, including the proposed tolerances for residues in dill and potato.

Processing studies in rapeseed, safflower and soybean have shown no concentration in any processed fraction, including oil.  Therefore, the processing factors in the DEEM residue input file were set to 1.0, indicating no concentration.  Even though the potato processing study was inadequate, chromatograms from the study were examined and no ethalfluralin residues were seen in processed potato commodities.  Therefore, no concentration was assumed in the dietary exposure assessment, and the default processing factor of 6.5x for dried potatoes was set to 1x.

For the cancer analysis, monitoring data from USDA’s Pesticide Data Program (PDP) were used for soybeans and watermelon.  For soybean, a total of 595 samples from 2003 contained no detectable residues, with a ½ LOD value of 0.0005 ppm.  For watermelon, 118 samples analyzed in 2005 contained no detectable residues, with a ½ LOD value of 0.0055 ppm.  For the proposed use on potatoes, the chromatograms included with the field trials support using the calculated LOD of 0.016 ppm.

 Drinking Water Data

Based on laboratory studies, ethalfluralin is expected to dissipate by binding to soil particles and then degrading both aerobically and anaerobically.  There are no major degradates detected; in laboratory studies, several minor degradates were identified, all of which retain the trifluromethyl phenolic ring structure.  Freundlich Kads values ranged from 12 to 97 ml/g and in the field ethalfluralin did not leach.  Laboratory metabolism half-lives in soil were 46 days for aerobic systems and 14 days for anaerobic systems.  Ethalfluralin does not hydrolyze, but does photodegrade rapidly in water with a half-life of approximately 6 hours.  The laboratory volatility study indicates this is not a major route of dissipation.

Tier II drinking water assessments for surface water for ethalfluralin were performed based on Index Reservoir settings.  The maximum simulation, the 1-in-10 year peak value, used for acute dietary exposure, was calculated for the use on canola using a maximum application rate of 1.15 lb ai/A.  The estimated drinking water concentration (EDWC) from this simulation was 11 ppb.  The maximum simulation for chronic exposures, or the 1-in-10 probability yearly, was calculated for the use on dill, with a maximum application rate of 1.5 lb ai/A.  The EDWC from this simulation was 0.4 ppb.  For cancer risk assessment, the average of yearly means was estimated to be 0.2 ppb.  In the dietary analyses, the peak value of 11 ppb was used for acute dietary assessment; for chronic dietary assessment, the 1-in 10-year average of 0.4 ppb was used.  These values were entered directly in to the DEEM-FCID model (as ppm, or 0.011 and 0.0004 ppm) for water, direct and indirect, all sources.

For ground water sources, the Tier I drinking water assessment predicted maximum EDWCs of 0.02 ppb for both acute and chronic exposure for the use on dill, with a maximum application rate of 1.5 lb ai/A.  The use of surface water estimates for drinking water in the dietary analysis is protective of potential residues in ground water.

For the cancer assessment, an anticipated residue value generated from the USDA PDP drinking water monitoring data was used; there were no residues detected in 1,253 samples analyzed from 2003 – 2005.  The ½ LOD value of 23 ppt (0.023 ppb) was used directly in the cancer dietary assessment for water, direct and indirect, all sources.  These data were considered to be appropriate to use for the cancer risk assessment for the following reasons:  1) application rates for both existing and proposed uses are similar; while peak drinking water estimates differ slightly from one crop to another, EFED’s modeled drinking water numbers for the average of yearly means did not differ significantly by crop, supporting the use of existing monitoring data to cover potential residues from the proposed uses; 2) the drinking water monitoring data were collected from a variety of states which include potential ethalfluralin use areas; 3) the lack of findings of detectable residues is supported by the modeled estimates and by the fate properties of ethalfluralin (e.g., 6-hour half-life for aqueous photolysis).

EM-FCID™ Program and Consumption Information

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

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

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (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 to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake 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.

V.	Toxicological Information

The doses and endpoints selected for dietary exposure and risk assessment for ethafluralin are shown below in Table 2.  [Ethalfluralin Human Health Risk Assessment for Proposed Uses on Dill and Potato, C. Swartz, DP Barcode Nos. D323068 and D323069, (10/19/2007)].

Table 2.  Toxicological Doses and Endpoints for Ethalfluralin for Use in Dietary Risk Assessments.

Exposure Scenario	Point of Departure	Uncertainty/

FQPA SFs	Population Adjusted Dose for Risk Assessment	Study and Toxicological Effects

Acute Dietary (General Population, including Infants and Children)	A single dose effect relevant to the general US population including infants and children was not identified in the toxicity studies conducted with ethalfluralin.

Acute Dietary

(Females 13-49 years of age)	NOAEL = 75 mg/kg/day	UFA = 10x

UFH = 10x

FQPA SF= 1x	aPAD = 0.75 mg/kg/day	Rabbit Dev. Toxicity Study

LOAEL = 150 mg/kg/day based on increased number of resorptions and increased sternal and cranial variations

Chronic Dietary (All Populations)	NOAEL = 4 mg/kg/day	UFA = 10x

UFH =10x

FQPA SF= 1x	cPAD = 0.04 mg/kg/day	Dog, Chronic Oral Toxicity Study

LOAEL = 20 mg/kg/day based on altered red blood cell morphology and urinary bilirubin

Cancer (oral, dermal, inhalation)	Q* = 8.9 x 10-2 (mg/kg/day)-1 based on increased mammary gland fibro-adenomas & combined adenomas/fiboadenomas in female rats	Rat 2-year chronic/carcinogenicity study

VI.	Results/Discussion

CID™ analyses estimate the dietary exposure of the U.S. population and various population subgroups.  Table 3 summarizes estimated acute dietary exposure and risk for females 13-49 years; chronic non-cancer risk for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years; and cancer risk for the general U.S. population only, per HED policy.

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis

Even though the acute dietary analysis for ethalfluralin uses anticipated residues, it is a conservative estimate of dietary exposure.  Because the food commodities that may be treated with ethalfluralin are blended commodities, it is appropriate to use AR values in the assessment.  Tolerance level residues were assumed for all other food commodities.  One hundred percent of all crops were assumed to be treated and to contain residues.  Estimated exposure for females 13-49 years was 0.000604 mg/kg/day, equivalent to <1% (0.08 %) of the aPAD, well below the Agency’s level of concern for acute dietary risk.  The results of the acute dietary risk assessment are summarized in Table 3.

Results of the Chronic Dietary (Food and Drinking Water) Non-Cancer and Cancer Exposure Analyses

The chronic non-cancer dietary analysis for ethalfluralin is a reasonable conservative estimate of dietary exposure that used AR values and assumed 100% crop treated; the AR values are the same as used in the acute dietary risk assessment.  The risk estimate of 0.000064 mg/kg/day for chronic dietary exposure to ethalfluralin for the U.S. population is equivalent to <1% of the cPAD, which is not of concern.  Similarly, the exposure estimate of 0.000133 mg/kg/day for the most exposed population subgroup, children 1 to 2 years, is <1% of the PAD, and is also not of concern.

The cancer dietary analysis for ethalfluralin, although more refined than the chronic non-cancer assessment, is also conservative because 100% CT was assumed.  The risk estimate for chronic cancer dietary exposure (0.000022 mg/kg/day) to ethalfluralin for the U.S. population yields a cancer risk estimate of 2 x 10-6.  EPA generally considers cancer risks of 10-6 or less to be below the level of concern.  The precision which can be assumed for cancer risk estimates is best described by rounding to the nearest integral order of magnitude on the log scale; for example, risks falling between 3.16 x 10-7 and 3.16 x 10-6 are expressed as 10-6.  Considering the precision with which cancer hazard can be estimated and the rounding procedure described above, cancer risk should generally not be assumed to exceed the benchmark level of concern of 10-6 until the calculated risk exceeds approximately 3 x 10-6.  Since the calculated cancer risk for ethalfluralin falls below this level, estimated cancer risk is considered to be below the level of concern.

Table 3.  Summary of Dietary  Food plus Drinking Water Exposure and Risk for Ethalfluralin

Population Subgroup	Acute Dietary

(95th Percentile)	Chronic Dietary	Cancer

	Dietary Exposure (mg/kg/day)	% aPAD	Dietary Exposure

(mg/kg/day)	% cPAD*	Dietary Exposure

(mg/kg/day)	Risk

General U.S. Population	N/A	N/A	0.000064	0.2	0.000022	1.96 x 10-6

All Infants (< 1 year old)

	0.000099	0.2	N/A	N/A

Children 1-2 years old1

	0.000133	0.3

Children 3-5 years old

	0.000124	0.3

Children 6-12 years old

	0.000085	0.2

Youth 13-19 years old

	0.000063	0.2

Adults 20-49 years old

	0.000054	0.1

Adults 50+ years old

	0.000053	0.1

Females 13-49 years old	0.000604	0.08	0.000051	0.1

1Most highly exposed population sub-group is displayed in bold.

VII.	Characterization of Inputs/Outputs

The acute and chronic dietary risk assessments conducted for ethalfluralin are considered somewhat refined because they use AR values instead of tolerance values for some commodities to estimate the residues in treated commodities.  However, the full LOD of 0.01 ppm was used only for blended commodities, per HED policy.  The tolerance, or proposed tolerance value in the case of dill and potato, of 0.05 ppm was used for all non-blended commodities.  Therefore, the dietary risk assessments provide reasonable worst case risk estimates, particularly since risk assessments assumed residues in 100% of the commodities (i.e., 100 % crop treated).  The chronic cancer dietary assessment is more refined, but is still conservative because 100 %CT was assumed.

VIII.	Conclusions

The results of the acute and chronic dietary risk assessments demonstrate estimated exposures are not of concern.  Therefore, the requested uses for ethalfluralin on dill and potatoes are supported.

IX.		List of Attachments

Attachment 1 – Acute Residue Input File

Attachment 2 – Acute Dietary (Food Plus Water) Risk Assessment Results

Attachment 3 – Chronic Non-Cancer Dietary (Food Plus Water) Input File

Attachment 4 – Chronic Non-Cancer Dietary (Food Plus Water) Risk Assessment Results

Attachment 5 – Chronic Cancer Dietary (Food Plus Water) Input File

Attachment 6 – Chronic Cancer Dietary (Food Plus Water) Risk Assessment Results

Attachment 1 – Acute Dietary (Food Plus Water) Residue Input File

U.S. Environmental Protection Agency                                 Ver. 2.02

DEEM-FCID Acute analysis for ETHALFLURALIN, 113101

Residue file name: C:\Documents and Settings\cswart02\My Documents\RAB2chemicals\Ethalfluralin\Ethalfluralin dietary\Dill_Potato_2007_acute.R98

Analysis Date 09-28-2007             Residue file dated: 09-28-2007/13:37:57/8

Reference dose: aRfD = 0.75 mg/kg bw/day  NOEL = 75 mg/kg bw/day

Comment: Standard UFs of 100X apply.

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Food Name                         (ppm)       #1    #2

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

09020210 9B   Balsam pear                        0.010000   1.000  1.000

06030300 6C   Bean, black, seed                  0.010000   1.000  1.000

06030320 6C   Bean, broad, seed                  0.010000   1.000  1.000

06030340 6C   Bean, cowpea, seed                 0.010000   1.000  1.000

06030350 6C   Bean,  great northern, seed        0.010000   1.000  1.000

06030360 6C   Bean, kidney, seed                 0.010000   1.000  1.000

06030380 6C   Bean, lima, seed                   0.010000   1.000  1.000

06030390 6C   Bean, mung, seed                   0.010000   1.000  1.000

06030400 6C   Bean, navy, seed                   0.010000   1.000  1.000

06030410 6C   Bean, pink, seed                   0.010000   1.000  1.000

06030420 6C   Bean, pinto, seed                  0.010000   1.000  1.000

09010750 9A   Cantaloupe                         0.010000   1.000  1.000

09010800 9A   Casaba                             0.010000   1.000  1.000

09020880 9B   Chayote, fruit                     0.010000   1.000  1.000

06030980 6C   Chickpea, seed                     0.010000   1.000  1.000

06030981 6C   Chickpea, seed-babyfood            0.010000   1.000  1.000

06030990 6C   Chickpea, flour                    0.010000   1.000  1.000

09021020 9B   Chinese waxgourd                   0.010000   1.000  1.000

09021350 9B   Cucumber                           0.010000   1.000  1.000

19021430 19B  Dill, seed                         0.050000   1.000  1.000

19011440 19A  Dillweed                           0.050000   1.000  1.000

06031820 6C   Guar, seed                         0.010000   1.000  1.000

06031821 6C   Guar, seed-babyfood                0.010000   1.000  1.000

09011870 9A   Honeydew melon                     0.010000   1.000  1.000

06032030 6C   Lentil, seed                       0.010000   1.000  1.000

06032560 6C   Pea, dry                           0.010000   1.000  1.000

06032561 6C   Pea, dry-babyfood                  0.010000   1.000  1.000

06032580 6C   Pea, pigeon, seed                  0.010000   1.000  1.000

95002630 O    Peanut                             0.010000   1.000  1.000

95002640 O    Peanut, butter                     0.010000   1.000  1.000

95002650 O    Peanut, oil                        0.010000   1.000  1.000

01032960 1C   Potato, chips                      0.050000   1.000  1.000

01032970 1C   Potato, dry (granules/ flakes)     0.050000   1.000  1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.050000   1.000  1.000

01032980 1C   Potato, flour                      0.050000   1.000  1.000

01032981 1C   Potato, flour-babyfood             0.050000   1.000  1.000

01032990 1C   Potato, tuber, w/peel              0.050000   1.000  1.000

01032991 1C   Potato, tuber, w/peel-babyfood     0.050000   1.000  1.000

01033000 1C   Potato, tuber, w/o peel            0.050000   1.000  1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   0.050000   1.000  1.000

09023080 9B   Pumpkin                            0.010000   1.000  1.000

09023090 9B   Pumpkin, seed                      0.010000   1.000  1.000

20003190 20   Rapeseed, oil                      0.050000   1.000  1.000

20003191 20   Rapeseed, oil-babyfood             0.050000   1.000  1.000

20003300 20   Safflower, oil                     0.050000   1.000  1.000

20003301 20   Safflower, oil-babyfood            0.050000   1.000  1.000

06003470 6    Soybean, seed                      0.010000   1.000  1.000

06003480 6    Soybean, flour                     0.010000   1.000  1.000

06003481 6    Soybean, flour-babyfood            0.010000   1.000  1.000

06003490 6    Soybean, soy milk                  0.010000   1.000  1.000

06003491 6    Soybean, soy milk-babyfood or in   0.010000   1.000  1.000

06003500 6    Soybean, oil                       0.010000   1.000  1.000

06003501 6    Soybean, oil-babyfood              0.010000   1.000  1.000

09023560 9B   Squash, summer                     0.010000   1.000  1.000

09023561 9B   Squash, summer-babyfood            0.010000   1.000  1.000

09023570 9B   Squash, winter                     0.010000   1.000  1.000

09023571 9B   Squash, winter-babyfood            0.010000   1.000  1.000

20003640 20   Sunflower, seed                    0.010000   1.000  1.000

20003650 20   Sunflower, oil                     0.010000   1.000  1.000

20003651 20   Sunflower, oil-babyfood            0.010000   1.000  1.000

86010000 O    Water, direct, all sources         0.011000   1.000  1.000

86020000 O    Water, indirect, all sources       0.011000   1.000  1.000

09013990 9A   Watermelon                         0.010000   1.000  1.000

09014000 9A   Watermelon, juice                  0.010000   1.000  1.000

Attachment 2 – Acute Dietary (Food Plus Water) Risk Assessment Results

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for ETHALFLURALIN, 113101               (1994-98 data)

Residue file: Dill_Potato_2007_acute.R98          Adjustment factor #2 NOT used.

Analysis Date: 09-28-2007/13:38:35    Residue file dated: 09-28-2007/13:37:57/8

NOEL (Acute) =  75.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "Standard UFs of 100X apply."

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

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th Percentile

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

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

Females 13-49 yrs:

  0.000604    0.08  124249    0.000931    0.12   80558    0.001644    0.22   45630

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for ETHALFLURALIN, 113101               (1994-98 data)

Residue file: Dill_Potato_2007_acute.R98          Adjustment factor #2 NOT used.

Analysis Date: 09-28-2007/13:38:35    Residue file dated: 09-28-2007/13:37:57/8

NOEL (Acute) =  75.000000 mg/kg body-wt/day

Acute Reference Dose (aRfD) =   0.750000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "Standard UFs of 100X apply."

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

Females 13-49 yrs                  Daily Exposure Analysis  /a

-----------------                  (mg/kg body-weight/day)

                                    per Capita    per User

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

            Mean                      0.000259     0.000259

            Standard Deviation        0.000193     0.000193

            Standard Error of mean    0.000003     0.000003

            Margin of Exposure 2/      289,832      289,797

            Percent of aRfD               0.03         0.03

       Percent of Person-Days that are User-Days =  99.99%

  Estimated percentile of user-days falling below calculated exposure

    in mg/kg body-wt/day with Margin of Exposure (MOE) and Percent of aRfD

Perc.   Exposure    % aRfD     MOE       Perc.  Exposure    % aRfD      MOE

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

10.00     0.000072     0.01 >1,000,000   90.00    0.000485     0.06    154,568

20.00     0.000112     0.01    671,414   95.00    0.000604     0.08    124,243

30.00     0.000147     0.02    511,423   97.50    0.000734     0.10    102,148

40.00     0.000183     0.02    409,933   99.00    0.000931     0.12     80,556

50.00     0.000218     0.03    343,583   99.50    0.001120     0.15     66,951

60.00     0.000258     0.03    291,040   99.75    0.001297     0.17     57,846

70.00     0.000304     0.04    247,016   99.90    0.001644     0.22     45,630

80.00     0.000376     0.05    199,552

  Estimated percentile of per-capita days falling below calculated exposure

    in mg/kg body-wt/day with Margin of Exposure (MOE) and Percent of aRfD

Perc.   Exposure    % aRfD     MOE       Perc.  Exposure    % aRfD      MOE

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

10.00     0.000071     0.01 >1,000,000   90.00    0.000485     0.06    154,573

20.00     0.000112     0.01    671,673   95.00    0.000604     0.08    124,249

30.00     0.000147     0.02    511,506   97.50    0.000734     0.10    102,150

40.00     0.000183     0.02    410,002   99.00    0.000931     0.12     80,558

50.00     0.000218     0.03    343,617   99.50    0.001120     0.15     66,952

60.00     0.000258     0.03    291,063   99.75    0.001297     0.17     57,847

70.00     0.000304     0.04    247,033   99.90    0.001644     0.22     45,630

80.00     0.000376     0.05    199,561

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

a/ Analysis based on all two-day participant records in CSFII 1994-98

   with 2 days of valid drinking water records.

2/ Margin of Exposure = NOEL/ Dietary Exposure

Attachment 3 – Chronic Non-Cancer Dietary (Food Plus Water) Input File

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for ETHALFLURALIN, 113101              1994-98 data

Residue file: C:\Documents and Settings\cswart02\My Documents\RAB2chemicals\Ethalfluralin\Ethalfluralin dietary\Dill_Potato_2007_chronic.R98

                                                           Adjust. #2 NOT used

Analysis Date 09-28-2007             Residue file dated: 09-28-2007/13:32:05/8

Reference dose (RfD) = 0.04 mg/kg bw/day

Comment:Standard UFs of 100X apply.

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

09020210 9B   Balsam pear                        0.010000   1.000      1.000

06030300 6C   Bean, black, seed                  0.010000   1.000      1.000

06030320 6C   Bean, broad, seed                  0.010000   1.000      1.000

06030340 6C   Bean, cowpea, seed                 0.010000   1.000      1.000

06030350 6C   Bean,  great northern, seed        0.010000   1.000      1.000

06030360 6C   Bean, kidney, seed                 0.010000   1.000      1.000

06030380 6C   Bean, lima, seed                   0.010000   1.000      1.000

06030390 6C   Bean, mung, seed                   0.010000   1.000      1.000

06030400 6C   Bean, navy, seed                   0.010000   1.000      1.000

06030410 6C   Bean, pink, seed                   0.010000   1.000      1.000

06030420 6C   Bean, pinto, seed                  0.010000   1.000      1.000

09010750 9A   Cantaloupe                         0.010000   1.000      1.000

09010800 9A   Casaba                             0.010000   1.000      1.000

09020880 9B   Chayote, fruit                     0.010000   1.000      1.000

06030980 6C   Chickpea, seed                     0.010000   1.000      1.000

06030981 6C   Chickpea, seed-babyfood            0.010000   1.000      1.000

06030990 6C   Chickpea, flour                    0.010000   1.000      1.000

09021020 9B   Chinese waxgourd                   0.010000   1.000      1.000

09021350 9B   Cucumber                           0.010000   1.000      1.000

19021430 19B  Dill, seed                         0.050000   1.000      1.000

19011440 19A  Dillweed                           0.050000   1.000      1.000

06031820 6C   Guar, seed                         0.010000   1.000      1.000

06031821 6C   Guar, seed-babyfood                0.010000   1.000      1.000

09011870 9A   Honeydew melon                     0.010000   1.000      1.000

06032030 6C   Lentil, seed                       0.010000   1.000      1.000

06032560 6C   Pea, dry                           0.010000   1.000      1.000

06032561 6C   Pea, dry-babyfood                  0.010000   1.000      1.000

06032580 6C   Pea, pigeon, seed                  0.010000   1.000      1.000

95002630 O    Peanut                             0.010000   1.000      1.000

95002640 O    Peanut, butter                     0.010000   1.000      1.000

95002650 O    Peanut, oil                        0.010000   1.000      1.000

01032960 1C   Potato, chips                      0.050000   1.000      1.000

01032970 1C   Potato, dry (granules/ flakes)     0.050000   1.000      1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.050000   1.000      1.000

01032980 1C   Potato, flour                      0.050000   1.000      1.000

01032981 1C   Potato, flour-babyfood             0.050000   1.000      1.000

01032990 1C   Potato, tuber, w/peel              0.050000   1.000      1.000

01032991 1C   Potato, tuber, w/peel-babyfood     0.050000   1.000      1.000

01033000 1C   Potato, tuber, w/o peel            0.050000   1.000      1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   0.050000   1.000      1.000

09023080 9B   Pumpkin                            0.010000   1.000      1.000

09023090 9B   Pumpkin, seed                      0.010000   1.000      1.000

20003190 20   Rapeseed, oil                      0.050000   1.000      1.000

20003191 20   Rapeseed, oil-babyfood             0.050000   1.000      1.000

20003300 20   Safflower, oil                     0.050000   1.000      1.000

20003301 20   Safflower, oil-babyfood            0.050000   1.000      1.000

06003470 6    Soybean, seed                      0.010000   1.000      1.000

06003480 6    Soybean, flour                     0.010000   1.000      1.000

06003481 6    Soybean, flour-babyfood            0.010000   1.000      1.000

06003490 6    Soybean, soy milk                  0.010000   1.000      1.000

06003491 6    Soybean, soy milk-babyfood or in   0.010000   1.000      1.000

06003500 6    Soybean, oil                       0.010000   1.000      1.000

06003501 6    Soybean, oil-babyfood              0.010000   1.000      1.000

09023560 9B   Squash, summer                     0.010000   1.000      1.000

09023561 9B   Squash, summer-babyfood            0.010000   1.000      1.000

09023570 9B   Squash, winter                     0.010000   1.000      1.000

09023571 9B   Squash, winter-babyfood            0.010000   1.000      1.000

20003640 20   Sunflower, seed                    0.010000   1.000      1.000

20003650 20   Sunflower, oil                     0.010000   1.000      1.000

20003651 20   Sunflower, oil-babyfood            0.010000   1.000      1.000

86010000 O    Water, direct, all sources         0.000400   1.000      1.000

86020000 O    Water, indirect, all sources       0.000400   1.000      1.000

09013990 9A   Watermelon                         0.005500   1.000      1.000

09014000 9A   Watermelon, juice                  0.005500   1.000      1.000

Attachment 4 – Chronic Non-Cancer Dietary (Food Plus Water) Risk Assessment Results

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for ETHALFLURALIN, 113101            (1994-98 data)

Residue file name: C:\Documents and Settings\cswart02\My Documents\RAB2chemicals\Ethalfluralin\Ethalfluralin dietary\Dill_Potato_2007_chronic.R98

                                                 Adjustment factor #2 NOT used.

Analysis Date 09-28-2007/13:39:31     Residue file dated: 09-28-2007/13:32:05/8

Reference dose (RfD, Chronic) = .04 mg/kg bw/day

COMMENT 1: Standard UFs of 100X apply.

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.000064                 0.2%

U.S. Population (spring season)             0.000064                 0.2%

U.S. Population (summer season)             0.000066                 0.2%

U.S. Population (autumn season)             0.000064                 0.2%

U.S. Population (winter season)             0.000063                 0.2%

Northeast region                            0.000058                 0.1%

Midwest region                              0.000070                 0.2%

Southern region                             0.000064                 0.2%

Western region                              0.000064                 0.2%

Hispanics                                   0.000070                 0.2%

Non-hispanic whites                         0.000064                 0.2%

Non-hispanic blacks                         0.000059                 0.1%

Non-hisp/non-white/non-black                0.000069                 0.2%

All infants (< 1 year)                      0.000099                 0.2%

Nursing infants                             0.000037                 0.1%

Non-nursing infants                         0.000123                 0.3%

Children 1-6  yrs                           0.000124                 0.3%

Children 7-12 yrs                           0.000082                 0.2%

Females 13-19 (not preg or nursing)         0.000056                 0.1%

Females 20+ (not preg or nursing)           0.000050                 0.1%

Females 13-50 yrs                           0.000054                 0.1%

Females 13+ (preg/not nursing)              0.000052                 0.1%

Females 13+ (nursing)                       0.000061                 0.2%

Males 13-19 yrs                             0.000070                 0.2%

Males 20+ yrs                               0.000057                 0.1%

Seniors 55+                                 0.000053                 0.1%

Children 1-2 yrs                            0.000133                 0.3%

Children 3-5 yrs                            0.000124                 0.3%

Children 6-12 yrs                           0.000085                 0.2%

Youth 13-19 yrs                             0.000063                 0.2%

Adults 20-49 yrs                            0.000054                 0.1%

Adults 50+ yrs                              0.000053                 0.1%

Females 13-49 yrs                           0.000051                 0.1%

Attachment 5 – Chronic Cancer Dietary (Food Plus Water) Input File

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for ETHALFLURALIN, 113101              1994-98 data

Residue file: C:\Documents and Settings\cswart02\My Documents\RAB2chemicals\Ethalfluralin\Ethalfluralin dietary\Dill_Potato_2007_cancer.R98

                                                           Adjust. #2 NOT used

Analysis Date 09-28-2007             Residue file dated: 09-28-2007/13:37:33/8

Q* = 0.089

Comment:Standard UFs of 100X apply.

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

09020210 9B   Balsam pear                        0.010000   1.000      1.000

06030300 6C   Bean, black, seed                  0.010000   1.000      1.000

06030320 6C   Bean, broad, seed                  0.010000   1.000      1.000

06030340 6C   Bean, cowpea, seed                 0.010000   1.000      1.000

06030350 6C   Bean,  great northern, seed        0.010000   1.000      1.000

06030360 6C   Bean, kidney, seed                 0.010000   1.000      1.000

06030380 6C   Bean, lima, seed                   0.010000   1.000      1.000

06030390 6C   Bean, mung, seed                   0.010000   1.000      1.000

06030400 6C   Bean, navy, seed                   0.010000   1.000      1.000

06030410 6C   Bean, pink, seed                   0.010000   1.000      1.000

06030420 6C   Bean, pinto, seed                  0.010000   1.000      1.000

09010750 9A   Cantaloupe                         0.010000   1.000      1.000

09010800 9A   Casaba                             0.010000   1.000      1.000

09020880 9B   Chayote, fruit                     0.010000   1.000      1.000

06030980 6C   Chickpea, seed                     0.010000   1.000      1.000

06030981 6C   Chickpea, seed-babyfood            0.010000   1.000      1.000

06030990 6C   Chickpea, flour                    0.010000   1.000      1.000

09021020 9B   Chinese waxgourd                   0.010000   1.000      1.000

09021350 9B   Cucumber                           0.010000   1.000      1.000

19021430 19B  Dill, seed                         0.050000   1.000      1.000

19011440 19A  Dillweed                           0.050000   1.000      1.000

06031820 6C   Guar, seed                         0.010000   1.000      1.000

06031821 6C   Guar, seed-babyfood                0.010000   1.000      1.000

09011870 9A   Honeydew melon                     0.010000   1.000      1.000

06032030 6C   Lentil, seed                       0.010000   1.000      1.000

06032560 6C   Pea, dry                           0.010000   1.000      1.000

06032561 6C   Pea, dry-babyfood                  0.010000   1.000      1.000

06032580 6C   Pea, pigeon, seed                  0.010000   1.000      1.000

95002630 O    Peanut                             0.010000   1.000      1.000

95002640 O    Peanut, butter                     0.010000   1.000      1.000

95002650 O    Peanut, oil                        0.010000   1.000      1.000

01032960 1C   Potato, chips                      0.016000   1.000      1.000

01032970 1C   Potato, dry (granules/ flakes)     0.016000   1.000      1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.016000   1.000      1.000

01032980 1C   Potato, flour                      0.016000   1.000      1.000

01032981 1C   Potato, flour-babyfood             0.016000   1.000      1.000

01032990 1C   Potato, tuber, w/peel              0.016000   1.000      1.000

01032991 1C   Potato, tuber, w/peel-babyfood     0.016000   1.000      1.000

01033000 1C   Potato, tuber, w/o peel            0.016000   1.000      1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   0.016000   1.000      1.000

09023080 9B   Pumpkin                            0.010000   1.000      1.000

09023090 9B   Pumpkin, seed                      0.010000   1.000      1.000

20003190 20   Rapeseed, oil                      0.050000   1.000      1.000

20003191 20   Rapeseed, oil-babyfood             0.050000   1.000      1.000

20003300 20   Safflower, oil                     0.050000   1.000      1.000

20003301 20   Safflower, oil-babyfood            0.050000   1.000      1.000

06003470 6    Soybean, seed                      0.000500   1.000      1.000

06003480 6    Soybean, flour                     0.000500   1.000      1.000

06003481 6    Soybean, flour-babyfood            0.000500   1.000      1.000

06003490 6    Soybean, soy milk                  0.000500   1.000      1.000

06003491 6    Soybean, soy milk-babyfood or in   0.000500   1.000      1.000

06003500 6    Soybean, oil                       0.000500   1.000      1.000

06003501 6    Soybean, oil-babyfood              0.000500   1.000      1.000

09023560 9B   Squash, summer                     0.010000   1.000      1.000

09023561 9B   Squash, summer-babyfood            0.010000   1.000      1.000

09023570 9B   Squash, winter                     0.010000   1.000      1.000

09023571 9B   Squash, winter-babyfood            0.010000   1.000      1.000

20003640 20   Sunflower, seed                    0.010000   1.000      1.000

20003650 20   Sunflower, oil                     0.010000   1.000      1.000

20003651 20   Sunflower, oil-babyfood            0.010000   1.000      1.000

86010000 O    Water, direct, all sources         0.000023   1.000      1.000

86020000 O    Water, indirect, all sources       0.000023   1.000      1.000

09013990 9A   Watermelon                         0.005500   1.000      1.000

09014000 9A   Watermelon, juice                  0.005500   1.000      1.000

Attachment 6 – Chronic Cancer Dietary (Food Plus Water) Risk Assessment Results

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for ETHALFLURALIN, 113101            (1994-98 data)

Residue file name: C:\Documents and Settings\cswart02\My Documents\RAB2chemicals\Ethalfluralin\Ethalfluralin dietary\Dill_Potato_2007_cancer.R98

                                                 Adjustment factor #2 NOT used.

Analysis Date 09-28-2007/13:40:06     Residue file dated: 09-28-2007/13:37:33/8

Q* = 0.089

COMMENT 1: Standard UFs of 100X apply.

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

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                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg         Lifetime risk

           Subgroup                       body wt/day       (Q*= .089)

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

U.S. Population (total)                     0.000022         1.94E-06

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

Ethalfluralin	Dietary Exposure and Risk Assessment	DP Number: 333868

PC Code:  113101

________________________________________________________________________ ______________

 PAGE

Page   PAGE  1  of   NUMPAGES  19


[Federal Register Volume 88, Number 30 (Tuesday, February 14, 2023)]
[Notices]
[Pages 9516-9517]
[FR Doc No: 2023-03050]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2011-0824; FRL-10651-01-OECA]

Proposed Information Collection Request; Comment Request;
Application for Registration and Pesticide Report for Pesticide-
Producing and Device-Producing Establishments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``Application for Registration
and Pesticide Report for Pesticide-Producing and Device-Producing
Establishments'' (EPA ICR No. 0160.12, OMB Control No. 2070-0078) to
the Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. Before doing so, EPA is
soliciting public comments on specific aspects of the proposed
information collection as described below. This is a proposed extension
of the ICR, which is currently approved through September 30, 2023. An
Agency may not conduct or sponsor and a person is not required to
respond to a collection of information unless it displays a currently
valid OMB control number.

DATES: Comments must be submitted on or before April 17, 2023.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OECA-
2011-0824, online using www.regulations.gov (our preferred method) or
by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Michelle Yaras, Office of Compliance,
Monitoring, Assistance, and Media Programs Division, Pesticides, Waste
& Toxics Branch (2225A), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202)
564-4153; email: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) Section 7(a) requires that any person who produces pesticides,
active ingredients or devices subject to the Act must register with the
Administrator of EPA the establishment in which the pesticide, active
ingredient or device is produced. This section further requires that
application for registration of any establishment shall include the
name and address of the establishment and of the producer who operates
such an establishment. EPA Form 3540-8, Application for Registration of
Pesticide-Producing and Device-Producing Establishments, is used to
collect the establishment registration information required by this
section.
    FIFRA Section 7(c) requires that any producer operating an
establishment registered under Section 7 report to the Administrator
within 30 days after it is registered, and annually thereafter by March
1st for certain pesticide or device production and sales or
distribution information. The producers must report which types and
amounts of pesticides, active ingredients, or devices are currently
being produced, were produced during the past year, sold or distributed
in the past year. The supporting regulations at 40 CFR part 167 provide
the requirements and time schedules for submitting production
information. EPA Form 3540-16, Pesticide Report for Pesticide-Producing
and Device-Producing Establishments, is used to collect the pesticide
production information required by Section 7(c) of FIFRA.
    Establishment registration information, collected on EPA Form 3540-
8, is a one-time requirement for all pesticide-producing and device-
producing establishments. Pesticide and device production information,
reported on EPA Form 3540-16, is required to be submitted within 30
days after the company is notified of their pesticide-producing or
device-producing establishment number, and annually thereafter on or
before March 1st. Pesticide-producing and device-producing
establishments optionally can electronically enter and submit their
establishment registration information and pesticide production
information through EPA's Central Data Exchange (CDX).
    Form Numbers: 3540-8 and 3540-16.

    Respondents/affected entities: Establishments producing pesticides.
    Respondent's obligation to respond: Mandatory (40 CFR part 167).
    Estimated number of respondents: 19,114 (total).
    Frequency of response: Annually.
    Total estimated burden: 48,830.40 hours (per year). Burden is
defined at 5 CFR 1320.03(b).
    Total estimated cost: $3,724,075.10 (per year), includes $0
annualized capital or operation & maintenance costs.
    Changes in estimates: There is an increase of 5,993.68 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This increase is a result of the COVID-19 pandemic
causing a 109.1 percent increase in the average number of new
establishments (815 in 2019 to 1703 in 2023) and a 34.15% increase in
the total number of establishments (14,248 in 2019 to 19,114 in 2023).
Additional increases are due to the increase in the salary tables used
in the calculations.

Elizabeth Vizard,
Acting Director, Office of Compliance/MAMPD.
[FR Doc. 2023-03050 Filed 2-13-23; 8:45 am]
BILLING CODE 6560-50-P


From:		Caryn Muellerleile [  HYPERLINK <EMAIL_ADDRESS><EMAIL_ADDRESS>]

Sent:		07/27/2012 12:38 PM EDT

To:		Frey, Nathan J. <  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>>

Cc:		Robin Dunkins <  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>>

Subject:	Re: Package For OMB

Thanks, the amended package is now in ROCIS.

Caryn

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

From:		Frey, Nathan J. <  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>>

To:		Caryn Muellerleile/DC/USEPA/US@EPA

Cc:		Robin Dunkins/RTP/USEPA/US@EPA

Date:		07/27/2012 11:51 AM

Subject:	Re: Package For OMB

Sorry I'm off site today but I've asked someone to open it up. Check back in rocis after a bit.

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

From:		Caryn Muellerleile [  HYPERLINK <EMAIL_ADDRESS><EMAIL_ADDRESS>]

Sent:		Friday, July 27, 2012 11:26 AM

To:		Frey, Nathan J. <  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>>

Cc:		Robin Dunkins <  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>>

Subject:	Fw: Package For OMB

Hi Nathan,

I'm in ROCIS now and I do not see Pulp & Paper (RIN 2060-AQ41) open for amendment. Can you help out?

Thanks,

Caryn

Caryn Muellerleile

Regulatory Management Division

Office of Policy

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW (1806A)

Washington, DC 20460

(202) 564-2855

(202) 564-0965 – fax

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>


[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Notices]
[Page 26770]
[FR Doc No: 2013-10954]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER13-1368-000]

NaturEner Wind Watch, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
NaturEner Wind Watch, LLC's application for market-based rate
authority, with an accompanying rate schedule, noting that such
application includes a request for blanket authorization, under 18 CFR
Part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability is May 22, 2013.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: May 2, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-10954 Filed 5-7-13; 8:45 am]
BILLING CODE 6717-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on April 22, 2003

NOTICE OF ACTION TAKEN -- DOCKET OST 1997-2091

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  GUJA, S.A. de C.V.
                                          Date Filed:  March 28, 2003

Relief requested:  Exemption from 49 USC section 41301 to permit the
applicant to continue to conduct passenger charter operations between
Mexico and the United States, and other passenger charters in accordance
with 14 CFR Part 212, using small equipment.

If renewal, date and citation of last action:  April 17, 2002, in this
Docket.

Applicant representative:  Lee A. Bauer,<PHONE_NUMBER>             DOT
analyst:  Allen Brown,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved
                                               Action date:  April 22,
2003

Effective dates of authority granted:  April 22, 2003, through April 22,
2004

Basis for approval (bilateral agreement/reciprocity):  United
States-Mexico Air Transport Services Agreement of August 15, 1960, as
amended and extended (Agreement).

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

     X  Standard exemption conditions.

Special conditions/Partial grant/Denial basis/Remarks:  In the conduct
of these operations, the carrier must adhere to all applicable
provisions of the U.S.-Mexico Agreement.  In the conduct of these
operations, the carrier may only use aircraft capable of carrying no
more than 60 passengers and having a maximum payload capacity of no more
than 18,000 pounds (small equipment).  The above grant includes
authority to conduct Third and Fourth Freedom charter operations.  While
we have subjected, consistent with the provisions of the Agreement,
Mexican carriers conducting charter operations with large aircraft to
prior approval or submission of notice for their Third and Fourth
Freedom charters, we determined that any such requirement was not
necessary on public interest grounds in this case, since the carrier
will be conducting these operations solely with small aircraft.  (Other
charter operations to/from the United States under this authority,
however, are subject to prior approval under 14 CFR Part 212.)  Further,
we are continuing to allow Mexican carriers conducting passenger
charters using small equipment to make stopovers in the United States in
the conduct of such operations.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp


[Federal Register: October 29, 2009 (Volume 74, Number 208)]
[Notices]
[Page 55890]
[DOCID:fr29oc09-127]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Availability of the Record of Decision for the Final
Environmental Impact Statement and the Alaska National Interest Lands
Conservation Act Section 810 Analysis of Impacts to Subsistence
Resources for Proposed Improvement Activities at the Sitka Rocky
Gutierrez Airport, Sitka, AK

AGENCY: Federal Aviation Administration, Department of Transportation.

ACTION: Notice of availability.

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SUMMARY: The Federal Aviation Administration (FAA) is publishing this
notice to advise the public that the FAA has issued a Record of
Decision (ROD) for the Final Environmental Impact Statement (Final EIS)
and Alaska National Interest Lands Conservation Act (ANILCA) Section
810 Evaluation for Proposed Improvement Activities at the Sitka Rocky
Gutierrez Airport (SIT) on September 28, 2009. The ROD provides final
agency determinations and approvals for the proposed airport
improvement activities.
    Record of Decision Availability: Copies of the ROD may be viewed
during regular business hours at the following locations:
    1. Kettleson Memorial Library, 320 Harbor Drive, Sitka, AK 99835.
(907) 747-8708.
    2. Downtown Juneau Public Library, 292 Marine Way, Juneau, AK
99801.<PHONE_NUMBER>.
    The ROD is posted to the following Web site: http://www.faa.gov/
airports/environmental/records_decision/. Additionally, the FAA,
Airports Division has a limited number of copies of the ROD available
for public distribution. Please contact the FAA at<PHONE_NUMBER> for a
copy.

SUPPLEMENTARY INFORMATION: The ROD provides final determinations and
approvals by the FAA for federal actions needed to enhance aviation
safety and protect current and future aviation uses at Sitka Rocky
Gutierrez Airport, Sitka, Alaska. Included within the ROD are
descriptions of the six projects proposed by the Airport Sponsor (the
Alaska Department of Transportation and Public Facilities) and the
documented need for each project, alternatives to the proposed actions,
environmental impacts associated with the actions and alternatives, and
mitigation measures required to avoid or minimize environmental harm.
The ROD also discloses the federal, state, and local actions needed
prior to the implementation of each of the projects and provides
findings, certifications, and determinations concerning resources of
special concern. Conditions of approval that must be met by the Alaska
Department of Transportation and Public Facilities prior to
construction are also listed. The ROD identifies the FAA's preferred
and environmentally preferred alternatives, as well as those
alternatives selected by the FAA for implementation. Additionally, the
ROD explains the authorization that must be granted by the Department
of Interior's Bureau of Land Management to convey federal lands to the
state of Alaska for aviation and airport uses.
    The FAA's selected alternatives identified in the ROD are:
     Runway Safety Area Alternative 5: Declared Distances with
280-Foot Landmass Expansion on Runway End 29 and Additional Runway
Pavement
     Parallel Taxiway Alternative 3: Partial Extension of the
Parallel Taxiway to Charcoal Island
     Seaplane Pullout Alternative 2: Construction of Fixed Ramp
Seaplane Pullout on Charcoal Island
     Approach Lighting System Alternative 1: No Action
     Seawall Alternative 1: No Action
     Land Transfer Alternative 2: Transfer of Property Rights
within Airport Boundary to Alaska from the United States using a
Combination of Title Conveyance and Long-Term Lease or Easement
    The ROD also provides the final determination on the ANILCA Section
810 Evaluation for the actions included in the Final EIS. Section 810
of ANILCA requires an evaluation of the effects of alternatives
presented in this Final EIS on subsistence activities occurring on
public lands located in the planning area. The evaluation in the Final
EIS indicates that none of the alternatives significantly restrict
subsistence activities.
    The notice of availability for the Final EIS was published by the
Environmental Protection Agency on May 22, 2009. The FAA issued its ROD
on the Final EIS on September 28, 2009.

FOR FURTHER INFORMATION CONTACT: Patricia Sullivan, Environmental
Specialist, Federal Aviation Administration, Alaskan Region, Airports
Division, 222 W. 7th Avenue, 14, Anchorage, AK 99513-7504. Ms.
Sullivan may be contacted during business hours at<PHONE_NUMBER>
(phone) and<PHONE_NUMBER> (facsimile).

    Issued in Anchorage, Alaska on October 19, 2009.
Patricia A. Sullivan,
Acting Manager, Airports Division, Alaskan Region.
[FR Doc. E9-25834 Filed 10-28-09; 8:45 am]

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