[Federal Register: March 25, 2009 (Volume 74, Number 56)]
[Rules and Regulations]
[Page 12553]
[DOCID:fr25mr09-6]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2009-0156]
RIN 1625-AA09

Drawbridge Operation Regulation; Upper Mississippi River, Rock
Island, IL

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Eighth Coast Guard District has issued a
temporary deviation from the regulation governing the operations of the
Rock Island Railroad and Highway Drawbridge, Mile 482.9, Rock Island,
Illinois across the Upper Mississippi River. This deviation allows the
bridge to remain in the closed to navigation position from 7:30 a.m.
until 11:30 a.m., September 27, 2009. The deviation is necessary as the
drawbridge is part of the annual route for the Quad City Marathon.

DATES: This temporary deviation is effective from 7:30 a.m. until 11:30
a.m., September 27, 2009.

 Documents indicated in this preamble as being available in the docket
are part of docket USCG-2009-0157 and are available online at http://
www.regulations.gov. They are also available for inspection or copying
at two locations: the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays, and Commander,
Eighth Coast Guard District, Room 2.107F in the Robert A. Young Federal
Building, 1222 Spruce Street, St. Louis, MO 63103-2832, between 8 a.m.
and 4 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Roger K. Wiebusch, Bridge
Administrator,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The U.S. Army Rock Island Arsenal requested
a temporary deviation for the Rock Island Railroad and Highway
Drawbridge, mile 482.9, at Rock Island, Illinois across the Upper
Mississippi to remain in the closed to navigation position as the
drawbridge is part of the Annual Quad City Marathon route. The Rock
Island Railroad and Highway Drawbridge currently operates in accordance
with 33 CFR 117.5, which states the general requirement that
drawbridges shall open promptly and fully for the passage of vessels
when a request to open is given in accordance with the subpart. In
order to facilitate the annual event, the drawbridge must be kept in
the closed-to-navigation position. This deviation allows the bridge to
remain in the closed-to-navigation position for four hours from 7:30
a.m. until 11:30 a.m., September 27, 2009.
    There are no alternate routes for vessels transiting this section
of the Upper Mississippi River.
    The Rock Island Railroad and Highway Drawbridge, in the closed-to-
navigation position, provides a vertical clearance of 23.8 feet above
normal pool. Navigation on the waterway consists primarily of
commercial tows and recreational watercraft. This temporary deviation
has been coordinated with waterway users. No objections were received.
    In accordance with 33 CFR 117.35(e), the drawbridge shall return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: March 10, 2009.
Roger K. Wiebusch,
Bridge Administrator.
 [FR Doc. E9-6666 Filed 3-24-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 87, Number 1 (Monday, January 3, 2022)]
[Notices]
[Pages 130-132]
[FR Doc No: 2021-28395]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93868; File No. SR-NASDAQ-2021-102]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Withdraw Its Trading Insights Product From Sale

December 27, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 16, 2021, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to withdraw its Trading Insights product from
sale.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/nasdaq/rules, at
the principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to withdraw the Trading
Insights product from sale. Trading Insights is an optional market data
service designed to help members analyze their own order activity.
Nasdaq has determined, however, that the product is no longer needed,
and, for certain components of the product, members are able to gather
similar insights into their own order activity using existing messaging
received on their order acknowledgments. Because Trading Insights is no
longer needed in the industry, Nasdaq has decided to redirect the
resources used to offer Trading Insights toward new tools and services,
and withdraw the product from sale.
Trading Insights
    Trading Insights is an optional market data service designed to
help members analyze their own order activity. It is comprised of three
components: (a) Missed Opportunity--Liquidity; (b) Missed Opportunity--
Latency; and (c) Peer Benchmarking.\3\
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    \3\ See Securities Exchange Act Release No. 78886 (September 20,
2016), 81 FR 66113 (September 26, 2016) (SR-Nasdaq-2016-101); see
also Securities Exchange Release No. 79035 (October 4, 2016), 81 FR
70207 (October 11, 2016) (SR-Nasdaq-2016-124) (setting fees for
Trading Insights); Securities Exchange Act Release No. 80856 (June
5, 2017), 82 FR 26820 (June 9, 2017) (SR-Nasdaq-2017-051) (modifying
fees to allow members to sponsor their customers to receive Trading
Insights and extending a free trial offer). The initial proposal had
included a Liquidity Dynamics Analysis component, which was to help
market participants identify pockets of accessible liquidity, but
the Exchange later announced that this component would be delayed
and was never made available to subscribers. See Securities Exchange
Release No. 79119 (October 19, 2016), 81 FR 73157 (October 24, 2016)
(SR-Nasdaq-2016-138).
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    The Missed Opportunity--Liquidity component identifies when an
order from a market participant could have been increased in size,
resulting in the execution of additional shares, and is designed to
provide information to a market participant interested in gaining
insight into pockets of liquidity.\4\
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    \4\ The data elements for this component, in summary, are: (i)
Issue (Nasdaq symbol for the issue); (ii) Buy/Sell Indicator (side
of the market at which the market participants are quoting); (iii)
Price (the price (inclusive of decimal point) at which Nasdaq Market
Center market participants had order interest for the given security
at the given time); (iv) Order Reference Number (the unique
reference number assigned to the new order at the time of receipt);
(v) Order Entry Time Stamp (the time order was received in the
system); (vi) Share Quantity (total number of shares submitted on
original order); and (vii) Missed Opportunity Quantity (total number
of shares missed).
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    The Missed Opportunity--Latency component identifies the amount of
time by which an otherwise marketable order missed execution, and is
designed to provide information to market participants interested in
optimizing their models and trading patterns.\5\
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    \5\ The data elements for this component, in summary, are: (i)
Issue (Nasdaq symbol for the issue); (ii) Buy/Sell Indicator (side
of the market at which the market participants are quoting); (iii)
Price (the price (inclusive of decimal point) at which Nasdaq Market
Center market participants had order interest for the given security
at the given time); (iv) Order Reference Number (the unique
reference number assigned to the new order at the time of receipt);
(v) Order Size; (vi) Matching Engine times for incoming orders;
(vii) Missed Opportunity times; and (viii) Reasons for not getting
fills. The Missed Opportunity--Latency component would not provide
specific information about resting orders on the Exchange order
book.
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    The Peer Benchmarking component ranks the quality of a market
participant's trading performance against its peers, allowing each
participant to view its relative trading performance by port.\6\ It is
designed to help participants better understand trends over time, their
relative performance relative to their competitors in general, and
whether behavioral changes translate into expected results.
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    \6\ A port is a means by which a member firm connects to
Nasdaq's systems. Each port would be categorized into a peer
grouping that would be based upon a given set of metrics that would
share similar trading behavior characteristics, and there would be
at least ten peers within a security. The data elements for this
component, in summary, include: (i) Total Dollar Volume; (ii) Total
Share Volume, Share Volume of Liquidity Provision and Accessible for
Tape A, Tape B and Tape C; (iii) Number of Trades, including Hidden
Orders and Number of Hidden Trades; (iv) Mean/Median Trade Size; (v)
Mean/Median Size of Hidden Orders; (vi) Number of Buy/Sell Orders
Received; (vii) Number of Aggressive Orders, Mean Size of Aggressive
Buy/Sell Orders; (viii) Number of Passive Orders, Mean Size of
Displayed Passive Order, Hidden Passive for Buy and Sell Orders;
(ix) Number of Orders at Best Bid/Ask Level; (x) Mean Cost to
Execute for Buy and Sell for 1,000, 5,000, 10,000 Shares; (xi)
Number of Modified/Cancelled Buy/Sell Orders; (xii) Mean Buy/Sell
Price Range; (xiii) Total Number of Buy/Sell Price; (xiv) Number,
Mean--Resting Buy/Sell Price Points; (xv) Missed Opportunities--
Liquidity, Latency; (xvi) Mean Share Volume Against Hidden, Mean
Quote Rotation Time.
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    All of the data offered by Trading Insights is specific to the
market participant's port, and no participant would be able to receive
another market participant's data.
    All data is provided on a T+1 basis.
Proposed Withdrawal
    Nasdaq regularly reviews its product catalog to ensure that the
tools and services it offers fit the needs of its customers. As
explained above, Trading Insights is an optional market data service
designed to help members analyze their own order activity. Nasdaq

has found, however, that members are able to use messaging received on
their order acknowledgments, coupled with internal software, to obtain
the same insights into trading activity that certain components of
Trading Insights was designed to convey.\7\ Because the product is no
longer needed in the industry, Nasdaq has decided to withdraw it and
its associated fees from the market.
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    \7\ Nasdaq had noted previously that some market participants
may be able to derive some of the data provided by Nasdaq Trading
Insights based on executions and internal algorithms created by
customers. See Securities Exchange Act Release No. 78886 (September
20, 2016), 81 FR 66113 (September 26, 2016) (SR-Nasdaq-2016-101).
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    The withdrawal of Trading Insights will not materially impact
either Nasdaq's members or the market as a whole. Currently, less than
ten customers purchase Trading Insights. Nasdaq has discussed the
proposed withdrawal with each, and none indicated that withdrawal would
materially impact their operations. Nasdaq also publicly announced its
intent to withdraw Trading Insights in a Data News publication issued
on October 1, 2021,\8\ and received no feedback indicating that
withdrawal would be problematic.
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    \8\ See Nasdaq Data News No. 2021-8 (October 1, 2021), available
at http://www.nasdaqtrader.com/TraderNews.aspx?id=dn2021-8.
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    Withdrawal of Trading Insights will not have a different impact on
different types of market participants. Members that currently purchase
the product have not indicated that they would be materially
disadvantaged by its withdrawal, and members that do not currently
purchase the product would remain unaffected.
    In light of the small number of customers currently using the
product, the ability of members to analyze their own order activity
using in-house software, and the lack of any negative feedback after
discussing the proposed withdrawal with Trading Insights customers and
announcing it publicly, Nasdaq proposes to withdraw Trading Insights
from sale as of December 31, 2021.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\9\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\10\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest, and is not designed to permit unfair discrimination between
customers, issuers, brokers or dealers.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
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    Withdrawing a product that is no longer needed in the industry is
the quintessence of competition. The Proposal promotes competition
because Nasdaq, like all of its competitors, has limited resources with
which to attract customers, and, to remain competitive, Nasdaq must use
its resources effectively. Withdrawal will allow Nasdaq to redirect its
internal resources into developing other products that more effectively
meet customer demand.
    The Proposal will not permit unfair discrimination between
customers, issuers, brokers, or dealers. Members that currently
purchase the product have not indicated that they would be materially
disadvantaged by its withdrawal, and members that do not currently
purchase the product will remain unaffected. The Proposal therefore
does not permit unfair discrimination.
    For all of these reasons, the proposed withdrawal of Trading
Insights promotes just and equitable principles of trade, removes
impediments to and perfects the mechanism of a free and open market and
a national market system, and, in general, protects investors and the
public interest, and does not permit unfair discrimination.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
Intermarket Competition
    The withdrawal of Trading Insights will have no impact on
intermarket competition (the competition among SROs). As explained
above, the Proposal would allow Nasdaq to redirect its internal
resources into developing other products that more effectively meet
customer demand. Other platforms may use the opportunity of this
withdrawal to introduce their own versions of Trading Insights,
although, as is evident from Nasdaq's experience, such a product may
not elicit high customer demand.
Intramarket Competition
    The Proposal will not cause any unnecessary or inappropriate burden
on intramarket competition (competition among exchange customers). As
explained in our discussion of unfair discrimination above, members
that currently purchase the product have not indicated that they would
be materially disadvantaged by its withdrawal, and members that do not
currently purchase the product will remain unaffected. The Proposal
therefore will not cause any unnecessary or inappropriate burden on
intramarket competition.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \11\ and Rule 19b-
4(f)(6) thereunder.\12\
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has met this requirement.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \13\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \14\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has requested that the Commission waive the 30-day operative delay so
that it can withdraw Trading Insights on December 31, 2021. According
to the Exchange, it has publicly announced its intent to withdraw
Trading Insights in October 2021 and received no feedback indicating
that withdrawal would be problematic, and it has discussed the
withdrawal with each of the customers currently purchasing the product
and no customer indicated that withdrawal would materially impact their
operations. For these reasons, the Commission believes that waiver of
the 30-day operative delay is consistent with the protection of
investors and the public interest. Accordingly, the Commission hereby
waives the 30-day operative delay and designates the

proposed rule change operative upon filing.\15\
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    \13\ 17 CFR 240.19b-4(f)(6).
    \14\ 17 CFR 240.19b-4(f)(6)(iii).
    \15\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NASDAQ-2021-102 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-NASDAQ-2021-102. 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-NASDAQ-2021-102 and should be submitted
on or before January 24, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Vanessa A. Countryman,
Secretary.
[FR Doc. 2021-28395 Filed 12-30-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 243 (Monday, December 19, 2011)]
[Notices]
[Page 78732]
[FR Doc No: 2011-32455]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2011-0092]

Petition for Waiver of Compliance

    In accordance with part 211 of Title 49 Code of Federal Regulations
(CFR), this document provides the public notice that by a document
dated October 31, 2011, CSX Transportation (CSX) has petitioned the
Federal Railroad Administration (FRA) seeking approval for the
discontinuance or modification of a signal system. FRA has assigned the
petition Docket Number FRA-2011-0092.
    CSX seeks approval of the proposed modification of the bridge
tender controlled signals to automatic signals at the Trout River
Drawbridge in Jacksonville, FL, at Milepost S629.0, Kingsland
Subdivision, Jacksonville Division. The modification consists of the
conversion of bridge tender controlled signals to automatic signals.
    The reason given for the proposed change is that the drawbridge
tender position is being eliminated. Train crews will request that the
bridge open and close via dual-tone multi-frequency radio. Signals will
clear automatically for train movements once the bridge has been closed
and locked and an approach circuit is occupied. This proven technology
will allow the bridge to be safely operated for boat and rail traffic,
while reducing the personal safety risk associated with a manned
control house located on the center span.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at http://www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey Ave.
SE., W12-140, Washington, DC 20590. The Docket Operations Facility is
open from 9 a.m. to 5 p.m., Monday through Friday, except Federal
Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by February 2, 2012 will be considered by
FRA before final action is taken. Comments received after that date
will be considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the comment,
if submitted on behalf of an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (Volume 65, Number 70; Pages
19477-78), or online at http://www.dot.gov/privacy.html.

    Issued in Washington, DC, on December 14, 2011.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2011-32455 Filed 12-16-11; 8:45 am]
BILLING CODE 4910-06-P


Page 13 of 30 Table 3. Summary of Toxicological Dose and Endpoints for Isoxadifen Ethyl Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary  females 13 50 years old NOAEL = 15 mg/ kg/ day UF = 100 aRfD = 0.15 mg/ kg/ day FQPA SF = 1x aPAD = 0.15 mg/ kg/ day Rat Developmental Study. Bent scapula in rat fetuses at the LOAEL of 120 mg/ kg/ day occurred in the absence of maternal toxicity.

Acute Dietary  general population including infants and children   None. No appropriate toxicological endpoint attributable to a single exposure was identified for this population subgroup in the available toxicology studies.

Chronic Dietary  all populations NOAEL = 3.3 mg/ kg/ day UF = 100 cRfD = 0.033 mg/ kg/ day FQPA SF = 1x cPAD = 0.033 mg/ kg/ day 1 year dog feeding study, ( co critical) 90 day dog feeding study. Kidney histopathology in both sexes of dogs in both studies at the LOAEL of 6.1 mg/ kg/ day Short Term Dermal, Inhalation, and Incidental Oral ( 1 7 days) Oral NOAEL= 13.8 mg/ kg/ day dermal absorption rate = 14% inhalation absorption rate= 100% LOC for MOE < 100 ( occupational and residential) 90 day rat feeding study. Decreased body weight and weight gain at day 8 in 90 day rat feeding study at LOAEL of 137.9 mg/ kg/ day Intermediate ( 1 6 months) and Long Term (> 6 months) Dermal and Inhalation and Intermediate term ( 1 6 months Incidental Oral) Oral NOAEL= 3.3 mg/ kg/ day dermal absorption rate = 14% inhalation absorption rate= 100% LOC for MOE < 100 ( occupational and residential) 1 year dog feeding study, ( co critical) 90 day dog feeding study. Kidney histopathology in both sexes of dogs in both studies at the LOAEL of 6.1 mg/ kg/ day Cancer ( oral, dermal, inhalation) Cancer classification  " not likely to be a human carcinogen" Risk Assessment not required No evidence of carcinogenicity 3.4 Endocrine Disruption EPA is required under the Federal Food Drug and Cosmetic Act ( FFDCA), as amended by FQPA, to develop a screening program to determine whether certain substances ( including all pesticide active and other ingredients) " may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC), EPA determined that there was scientific bases for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use Federal Insecticide, Fungicide and Rodenticide Act ( FIFRA) and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA has authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program ( EDSP).

When the appropriate screening and/ or testing protocols being considered under the Agency's EDSP have been developed, isoxadifen ethyl may be subjected to additional screening and/ or testing to better characterize effects related to endocrine disruption. Page 14 of 30 4.0 EXPOSURE ASSESSMENT 4.1 Summary of Registered Uses Table 4. Summary of Registered Use Patterns for Isoxadifen ethyl Crops rice field corn Formulated product emulsifiable concentrate water soluble granule Use annual grassy weeds broadleaf weeds, annual and perennial grasses Application methods ( min spray vol) aerial and groundboom sprayer ( 10 gal/ acre) aerial and groundboom sprayer ( 5 gal/ acre)

Maximum application rate 0.083 lb. safener/ acre 0.023 0.036 lb. safener/ acre Maximum number of applications twice per season twice per season Maximum seasonal application rate 0.15 lb. safener/ acre 0.073 lb. safener/ acre Timing and frequency of applications apply from 1 leaf to early tillering ( before panicle initiation); retreatment interval ( RTI) 14 days; preharvest Interval ( PHI) = 65 days apply from emergence to V6 growth stage ( 0 20 inches height); only by ground drop nozzle application from V6 to V8 growth stage ( 20 36 inches); PHI for corn grain = 70 days; PHI for corn forage = 45 days Restrictions S water must be drained from the rice fields before application.; allow at least 24 hours following application before initiation of the paddy flood S do not use in areas where catfish and crayfish are commercially cultured;

S treated paddy water should not be used to irrigate crops not registered for use within 14 days of the last application of this product S a treated field may not be rotated to any corp within 9 months, after 9 months only soybeans may be planted S do not use on sweet corn, popcorn, or corn grown for seed 4.2 Summary of Proposed Uses The proposed application directions for turf are adequate. Table 5 is a summary of the proposed turf application scenario.

Table 5. Summary of Proposed Turf Use Pattern for Isoxadifen ethyl Crops turf Formulated product soluble concentrate ( SC)

Use herbicide safener Application methods foliar spray ( spray volume of 30 60 gallons/ acre)

Maximum application rate 0.0069 to 0.04 lb safener/ acre Maximum number of applications twice per season Maximum seasonal application rate 0.085 lb. safener/ acre Timing and frequency of applications application in the spring during transition from dormancy to activity Page 15 of 30 Restrictions restricted reentry interval  12 hours

4.3 Dietary Exposure/ Risk Pathway 4.3.1 Residue Profile HED has previously reviewed the residue chemistry data associated with the application of isoxadifen ethyl to rice and field corn ( D264135, W. Donovan, 16 Feb 2001; D266326, W. Donovan, 20 Feb 2001). Several residue chemistry deficiencies were noted. HED performed a risk assessment and concluded that time limited tolerances were appropriate ( D272957, W. Donovan et al., 24 Mar 2001). The petitioner has subsequently sent information, which HED has reviewed, addressing the residue chemistry deficiencies ( D273751, W. Donovan, 11 Apr 2001; D277090, W. Donovan, 6 Sep 2001; and D278331, W. Donovan, 25 Oct 2001; D295710, T. Bloem, 16 Oct 2003). Based on these additional data, the petitioner requested conversion of the currently established time limited tolerances to permanent tolerances.

Nature of the Residue  Plants: Metabolism data were submitted for rice and corn. The MARC determined that for rice the residues of concern, for tolerance expression and risk assessment purposes, are parent, AE F129431, and AE C637375, and that for corn the residues of concern, for the tolerance expression and risk assessment purposes, are parent and AE F129431 ( D271419, W. Donovan and W. Dykstra, 10 Jan 2001). The selection of the residues of concern was based on levels of the metabolites found in the metabolism and magnitude of the residue studies.

Nature of the Residue  Livestock: Metabolism data were submitted for livestock commodities derived from hens and dairy cows. The HED MARC determined that for livestock commodities the residues of concern, for tolerance expression and risk assessment purposes, are parent and AE F129431 ( D271419, W. Donovan and W. Dykstra, 10 Jan 2001). This decision was based on the finding that metabolite AE F129431 is the only compound found in significant quantities in livestock commodities.

Residue Analytical Methods: The analytical methods used in the field trial and processing studies have been adequately validated and are appropriate for data collection purposes. The petitioner proposed a capillary gas chromatography/ mass selective detection ( GC/ MSD) method for enfocement of the rice and field corn tolerances. The Analytical Chemistry Branch ( ACB) determined that the method is suitable for enforcement of the rice and field corn tolerances ( D293176, T. Bloem, 28 Aug 2003). HED forwarded the method to the U. S. Food and Drug Administration for publication in the Pesticide Analytical Manual II ( D293179, T. Bloem, 28 Aug 2003).

Multiresidue Method ( MRM): Isoxadifen ethyl was adequately recovered in/ on rice grain using Protocol E ( Method 303) and in/ on corn meal using Protocol F ( Method 304). Residues of AE F129431 were recovered quantitatively in/ on rice grain using Protocol B. No data were provided on the recovery of metabolite AE C637375 from the FDA multiresidue protocols. MRM testing data for AE C637375 are required. Upon submission of these data, HED will forward to FDA the MRM testing results for isoxadifen ethyl, AE F129431, and AE C637375. Page 16 of 30 Rice Magnitude of the Residue Data: An adequate number of geographically representative rice field trials were provided to indicate that tolerances for the combined residues of isoxadifen ethyl, AE F129431, and AE C637375 of 0.10 and 0.25 ppm in/ on rice grain and straw, respectively, are appropriate. For rice grain, all residues were less than the limit of quantitation ( LOQ) of 0.02 ppm except for one sample where AE C637375 was detected at 0.04 ppm. For rice straw, the maximum residue of AE F129431 was 0.15 ppm, while all samples had residues of isoxadifen ethyl and AE C637375

0.05 ppm ( LOQ).

Corn Magnitude of the Residue Data: An adequate number of geographically representative corn field trials were provided to indicate that tolerances for the combined residues of isoxadifen ethyl and AE F129431 of 0.10, 0.10, and 0.20 ppm in/ on corn grain, forage, and stover, respectively, are appropriate. For corn grain samples treated at 1x the maximum seasonal rate, the maximum residue of AE F129431 was 0.06 ppm, while isoxadifen ethyl residues were < 0.02 ppm ( LOQ). For all corn forage samples treated at 1x the maximum seasonal rate, isoxadifen ethyl and AE F129431 residues were less than the LOQ of 0.05 ppm. For corn stover samples treated at 1x the maximum seasonal rate, the maximum residue of AE F129431 was 0.13 ppm, while isoxadifen ethyl residues were < 0.05 ppm ( LOQ).

Processed Food/ Feed  Rice: The petitioner submitted an adequate rice processing study conducted at 5.1x the maximum seasonal application rate. The resulting data indicate that the combined residues of isoxadifen ethyl, AE F129431, and AE C637375 are reduced in polished rice ( 0.54x) and in rice bran ( 0.87x) and concentrate in rice hull ( 4.04x). Based on these data, HED concludes that a tolerance in/ on rice bran is not necessary and the currently established rice bran tolerance should be eliminated. Additionally, based on the highest average field trial residue (< 0.08 ppm) and the 4.04x processing factor for rice hull, HED concludes that the currently established 0.50 ppm rice hull tolerance is appropriate ( 0.08 x 4.04 = 0.32).

Processed Food/ Feed  Corn: The petitioner submitted an adequate field corn processing study conducted at 4.5x the maximum seasonal application rate. The resulting data indicate that the combined residues of isoxadifen ethyl and AE F122006 were below the method LOQ (< 0.02 ppm each) in/ on the unprocessed field corn grain. Since residues were < LOQ in/ on the raw agricultural commodity when treated at ~ 5x the maximum proposed application rate, HED concluded that tolerances in/ on field corn processed commodities are unnecessary.

Meat, Milk, Poultry, Eggs: Based on the maximum theoretical dietary burdens and available metabolism studies on hen and dairy cattle, HED concludes that tolerances are unnecessary for ruminant and poultry commodities at this time ( 40 CFR 180.6( a)( 3).

Confined Accumulation in Rotational Crops: The petitioner submitted a confined rotational crop study conducted with [ 14C phenyl] isoxadifen ethyl at 0.080 lb ai/ acre ( 1x and 0.5x the maximum seasonal rate for corn and rice, respectively). The treated plots were planted 30 days after application with radishes, wheat, lettuce, and soybean. Total radioactive residues ( TRRs) were all less than 0.01 ppm ( 0.003 0.009 ppm), with the exception of wheat straw at 0.012 ppm. Based on these data, HED concludes that crop rotation restrictions for isoxadifen ethyl use with field corn are unnecessary. Since the application rate for the confined study was 0.5x the maximum rate for rice, the results from this study are not applicable to rice. The petitioner indicated that in order to make the rice product viable, rotation to only soybeans with a 9 month plant back interval is necessary. Page 17 of 30 Based on the available data, HED concludes that this rotation crop interval is appropriate and no tolerances in/ on rotational crops are necessary. If the petitioner would like to allow rotation to crops other than soybeans following application to a rice field or established a shorter plant back interval for soybeans, then the petitioner should conduct, at a minimum, an adequate rotational crop study which depicts the nature and magnitude of the residues in rotational crops relative to the rice application rate.

4.3.2 Dietary Exposure Analysis Isoxadifen ethyl acute and chronic dietary exposure assessments were conducted using DEEMFCID   ( Ver 1.30), which incorporates consumption data from USDA's 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 EPAdefined 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. 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 years, children 3 5 years, children 6 12 years, youth 13 19 years, adults 20 49 years, females 13 49 years, and adults 50+ years old.

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. The resulting residue consumption estimate for each food/ food form is summed with the residue consumption estimates for all other food/ food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/ kg/ day and as a percent of the cPAD. This procedure is performed for each population subgroup. For acute exposure assessments, individual one day food consumption data are used on an individual by individual basis. The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or " matched" in multiple random pairings with residue values and then summed in a probabilistic assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user ( i. e., 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.

The acute and chronic analyses assumed tolerance level residues, 100% crop treated, and DEEM ( ver. 7.76) default concentration factors for all commodities ( D295708, T. Bloem, 29 Oct 2003). The acute dietary food exposure estimates to isoxadifen ethyl were < 1.0% aPAD for females 13   49 years old and are therefore less than HED's level of concern ( endpoint not identified for the remaining populations subgroups). The chronic dietary exposure estimates were

1.5% cPAD for all population subgroups and are therefore less than HED's level of concern ( highest exposed population subgroup  children 3 5 years old). Table 6 is a summary of the acute and chronic dietary exposure estimates. Page 18 of 30 Table 6. Summary of Dietary Exposure and Risk for Isoxadifen Ethyl Population Subgroup Acute Dietary ( 95th Percentile) Chronic Dietary Exposure ( mg/ kg/ day) % aPAD Exposure ( mg/ kg/ day) % cPAD General U. S. Population no endpoint identified 0.000216 < 1.0 All Infants (< 1 year old) 0.000339 1 Children 1 2 years old 0.000427 1.3 Children 3 5 years old 0.000486 1.5 Children 6 12 years old 0.000373 1.1 Youth 13 19 years old 0.000294 < 1.0 Adults 20 49 years old 0.000182 < 1.0 Adults 50+ years old 0.000099 < 1.0 Females 13 49 years old 0.000511 < 1.0 0.000177 < 1.0 4.4 Water Exposure/ Risk Pathway The following information concerning the environmental fate and drinking water assessment of isoxadifen ethyl was provided by EFED ( D272138, H. Craven and A. Clem, 02 Feb 2001).

Environmental Fate Assessment: Isoxadifen ethyl breaks down rapidly in the environment to form the corresponding carboxylic acid ( AE F129431). Acid AE F129431 is relatively short lived in soil and water, with variable half lives of approximately 1 2 weeks. The acid is also highly mobile, as indicated by Freundlich soil organic carbon coefficients ( Kfoc) in four soils of approximately 70, 80, 70, and 180 Freundlich units, where masses are in grams and volumes in milliliters ( median Kfoc = 78, average Kfoc = 100; median 1/ n = 0.83, average 1/ n = 0.83).

In aerobic and anaerobic aquatic environments, the acid degrades to give the nitrile AE C637375 and the amide AE C642961. In reported studies, the nitrile reached its highest concentration in an anaerobic soil system of approximately 88% of the radiolabeled dose, while in an anaerobic aquatic system it reached approximately 75% of the dose. In aquatic aerobic systems, maximum nitrile concentrations reached 35 45% of the dose. The nitrile appears to have a longer half life in aquatic environments than the parent or acid, but no values were given. The amide had a maximum concentration of 20 22% of the radiolabeled dose in the aerobic aquatic studies. In the anaerobic aquatic system, the maximum concentration of the amide was approximately 10 11% of the dose. In the anaerobic soil study, the amide reached only approximately 4% of the dose. None of the degradates are expected to bioconcentrate to any significant extent. Volatilization of parent and the metabolites is not expected to be a significant route of dissipation.

Ground and Surface Water EECs: The HED MARC determined that the residues of concern in drinking water are isoxadifen ethyl, AE F129431, AE C637375, and AE C642961 ( D271419, W. Donovan and W. Dykstra, 10 Jan 2001). Since ground or surface water monitoring data are not avialable, concentrations of the residues of concern in surface and ground water were made using computer modeling. The tier 1 acute and chronic EECs for surface water from GENEEC are 80 and 40 ppb, respectively. The acute and chronic EEC for ground water from SCI GROW is 5 ppb. Both models assumed a maximum seasonal application rate of 0.147 lb ai/ acre ( rice application rate, highest registered/ proposed application rate). Page 19 of 30 4.5 Residential/ Non Occupational Exposure Pathway Spray Drift: Spray drift is always a potential source of exposure to residents nearby to spraying operations. This is particularly the case with aerial application, but, to a lesser extent, could also be a potential source of exposure from groundboom application methods. The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices. The Agency is now requiring interim mitigation measures for aerial applications that must be placed on product labels/ labeling. The Agency has completed its evaluation of the new data base submitted by the Spray Drift Task Force, a membership of U. S. pesticide registrants, and is developing a policy on how to appropriately apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast, and ground hydraulic methods. After the policy is in place, the Agency may impose further refinements in spray drift management practices to reduce offtarget drift and risks associated with aerial as well as other application types where appropriate.

Exposure from Proposed Turf Use: The proposed turf use is intended for professional application to Bermudagrass on golf courses, sod farms, residential and commercial site lawns, parks, recreational facilities, and similar sites. It is not intended for use by homeowners or other nonprofessional applications. Therefore, residential mixer/ loader and applicator exposures are not anticipated. The following short term post application residential exposures are anticipated: adult ( dermal  golf course and residential lawn), child ( dermal  residential lawn), and toddler ( dermal and incidental oral  residential lawn). Since a common endpoint has been identified for short term dermal and incidental oral endpoints, these exposures were aggregated. The residential exposure assessment was conducted using the procedures in the HED Residential SOPs and as modified by SOP No. 12 ( D295128, M. Dow, 22 Oct 2003).

Dermal Exposure: Short term dermal exposures for golfers were not calculated as the assumptions made when performing this assessment result in dermal exposures less than those resulting from a residential lawn application. Therefore, the following discussion refers only to short term dermal exposure resulting form lawn application in the residential setting.

The default turf transferable residue ( TTR) estimate on the day of application is 5% of the application rate based on the HED Residential SOPs. Based on the maximum application rate of 0.04 lb ai/ acre ( 0.00045 mg/ cm2), the default day 0 dislodgeable foliar residue ( DFR) value is 0.0000225 mg/ cm2. SOP 12 has also established turf transfer coefficients of 14,500 cm2/ hr for adults and 5,200 cm2/ hr for children. A two hour exposure duration has been established by the Residential SOPs and is used in this assessment. The body weights for adults and children are 70 kg and 15 kg, respectively. Based on these values, the daily dermal adult and child post application lawn exposure estimates are calculated as follows:

adult: 0.0000225 mg/ cm2 x 14,500 cm2/ hr x 2 hr/ day ÷ 70 kg = 0.0093 mg/ kg bw/ day child: 0.0000225 mg/ cm2 x 5,200 cm2/ hr x 2 hr/ day ÷ 15 kg = 0.016 mg/ kg bw/ day Page 20 of 30 Incidental Oral Exposure: Hand to mouth ( HTM), object to mouth ( OTM), and soil hand to mouth short term incidental oral exposures may occur as a result of the proposed turf use. Soil hand to mouth exposure was not assessed by the petitioner. HED believes that under current policy the soil hand to mouth exposure will be negligible and will not impact the current risk assessment. Therefore the following discussion pertains only to HTM and OTM short term incidental oral exposures.

SOP 12 provides defaults for hand to mouth ( HTM) and object to mouth ( OTM) exposure. HTM exposure assumes the 5% transfer from turf to hands with a 20 cm2 hand surface area contact in the mouth, 20 insertions per hour during the two hour exposure duration, and 100% transference of residue from the hands to mouth. The OTM defaults assume 20% transference of residue from the turf to the object, a total contact of 25 cm2/ day, and 100% transfer of residue from the object to the mouth. The 20% residue of the initial 0.00045 mg/ cm2 application rate is 0.00009 mg/ cm2. Based on these defaults and the 15 kg body weight the HTM and OTM exposures are as follows:

HTM: 0.0000225 mg/ cm2 x 20 cm2/ insert x 20 inserts/ hr x 2 hr/ day ÷ 15 kg = 0.0012 mg/ kg/ day OTM: 0.00009 mg/ cm2 x 25 cm2/ day ÷ 15 kg = 0.00015 mg/ kg/ day Incidental Oral and/ or Dermal MOEs: The total estimated adult exposure is 0.0093 mg/ kg/ day and the total estimated child exposure is the sum of the dermal, HTM, and OTM exposures or 0.0174 mg/ kg/ day. Based on the NOEL of 13.8 mg/ kg/ day the MOEs for an adult and child following a professional lawn or turf application are as follows:

adult: 13.8 mg/ kg/ day ÷ 0.0093 mg/ kg/ day = 1500 child: 13.8 mg/ kg/ day ÷ 0.0174 mg/ kg/ day = 790 HEDs LOC is for MOEs < 100. Therefore, the proposed turf use does not exceed HEDs level of concern. Page 21 of 30 5.0 AGGREGATE RISK ASSESSMENTS AND RISK CHARACTERIZATION HED conducts aggregate exposure assessments by summing dietary ( food and water) and residential exposures ( residential or other non occupational exposures). Based on the proposed/ registered uses for isoxadifen ethyl, acute, short term, and chronic aggregate exposure assessments were calculated. Since HED does not have ground or surface water monitoring data to calculate quantitative aggregate exposure, DWLOCs were calculated. The DWLOC is the theoretical upper limit of a chemical's concentration in drinking water that will result in aggregate exposures less than HED's level of concern. DWLOC values are not regulatory standards for drinking water. DWLOCs were calculated using the following standard body weights and drinking water consumption figures: 70kg/ 2L ( adult male and US Population), 60 kg/ 2L ( adult female and youth), and 10kg/ 1L ( infant & children).

5.1 Acute Aggregate Risk The acute dietary exposure analysis assumed tolerance level residues, 100% crop treated, and DEEM ( ver 7.76) default processing factors for all commodities. The EECs generated by EFED are less than HED's DWLOCs. Thus, acute aggregate risk estimates are below HED's level of concern. Table 7 summarizes the acute aggregate exposure to isoxadifen ethyl.

Table 7. Acute Aggregate Exposure Population Subgroup aPAD mg/ kg/ day Food Exp mg/ kg/ day Max Water Exp1 mg/ kg/ day Surface Water EEC2 ( ppb) Ground Water EEC2 ( ppb) DWLOC3 ( ppb)

Females ( 13 50 years old) 0.15 0.000511 0.149489 80 5 4500 1 maximum water exposure ( mg/ kg/ day) = cPAD ( mg/ kg/ day)  food exposure ( mg/ kg/ day) 2 EECs generated using the GENEEC and SCI GROW models assuming a maximum seasonal application rate of 0.147 lb ai/ acre ( registered rice application scenario) 3 DWLOC = ( maximum water exposure) x ( body weigth) x ( 1000 µ g/ mg) ÷ ( liter/ day) Page 22 of 30 5.2 Short Term Aggregate Risk Since the proposed turf use is expected to result in non occupational exposures for adults ( dermal), children ( dermal), and infants ( incidental oral and dermal) and since a common endpoint has been identified for assessment of short term oral and dermal exposures ( decreased body weight and decreased weight gain), a short term aggregate exposure assessment considering exposure from food, water, and non occupational sources is necessary. Short term exposure has been defined as from 1 30 days and HED has concluded that chronic dietary exposure estimates will more accurately reflect actual exposure over these time periods than will high end ( acute) exposures. The residential lawn application of isoxadifen ethyl is expected to result in the highest short term dermal and incidental oral exposures. Therefore, the short term aggregate exposure assessment used the chronic dietary and residential lawn ( incidental oral and/ or dermal) exposure estimates. Since the acceptable MOE for each route of exposure is identical ( MOEs > 100), the short term aggregate exposure assessment was calculated using the reciprocal MOE approach.

The chronic dietary exposure analysis assumed tolerance level residues, 100% crop treated, and DEEM ( ver 7.76) default processing factors for all commodities. The residential dermal and incidental oral exposure estimates were calculated using the procedures in the HED Residential SOPs as modified by SOP No. 12 and are considered screening level. The Tier 1 chronic EECs generated by EFED are less than HED's DWLOC ( for all population subgroups). Thus, short term aggregate risk estimates are below HED's level of concern. Table 8 summarizes the short term aggregate exposure to isoxadifen ethyl. Page 23 of 30 Table 8. Short Term Aggregate Exposure Population Target Agg MOE1 MOE food2 MOE dermal3 MOE incidental oral4 Agg MOE ( food & res) 5 MOE water6 Allowable water exposure7 ( mg/ kg/ day) Ground Water EEC8 ( ppb) Surface Water EEC8 ( ppb) DWLOC9 ( ppb)

General U. S. Population 100 63889 1484  1450 107 0.128484 5 40 4500 All Infants (< 1 year old) 40708 863 10222 780 115 0.120311 1200 Children 1 2 years old 32319 863 10222 776 115 0.120223 1200 Children 3 5 years old 28395 863 10222 774 115 0.120164 1200 Children 6 12 years old 36997 863 10222 779 115 0.120277 1200 Youth 13 19 years old 46939 1484  1438 107 0.128406 3900 Adults 20 49 years old 75824 1484  1455 107 0.128518 4500 Adults 50+ years old 139394 1484  1468 107 0.128601 4500 Females 13 49 years old 77966 1484  1456 107 0.128523 3900 1 total UFs for all routes of exposure is 100x; therefore, the target MOE is 100 2 MOE food = short term incidental oral NOAEL ÷ chronic dietary exposure 3 MOE dermal = short term dermal NOAEL ÷ dermal residential exposure ( see Section 4.5)

4 MOE incidental oral = short term incidental oral NOAEL ÷ incidental oral exposure ( see Section 4.5)

5 aggregate MOE ( food and residential) = 1 ÷ ( ( 1 ÷ MOEfood) + ( 1 ÷ MOEdermal) + ( 1 ÷ MOEincidental oral))

6 water MOE = 1 ÷ (( 1 ÷ Target Aggregate MOE)  ( 1 ÷ Aggregate MOE ( food and residential)))

7 allowable water exposure = short term oral NOAEL ÷ MOE water 8 EECs generated using the GENEEC and SCI GROW models assuming a maximum seasonal application rate of 0.147 lb ai/ acre ( registered rice application scenario)

9 DWLOC(

g/ L) = ( allowable water exposure ( mg/ kg/ day) x body weight ( kg) x 1000

g/ mg) ÷ ( water consumption ( liters)) Page 24 of 30 5.3 Chronic Aggregate Risk The chronic dietary exposure analysis assumed tolerance level residues, 100% crop treated, and DEEM ( 7.76) default processing factors for all commodities. The EECs generated by EFED are less than HED's DWLOCs. Thus, chronic aggregate risk estimates are below HED's level of concern. Table 9 summarizes the chronic aggregate exposure to isoxadifen ethyl.

Table 9. Chronic Aggregate Exposures to Isoxadifen ethyl Residues Population cPAD ( mg/ kg/ day) Chronic Food Exposure ( mg/ kg/ day) Max Chronic Water Exposure1 ( mg/ kg/ day) Ground Water EEC2 ( ppb) Surface Water EEC2 ( ppb) Chronic DWLOC3 ( ppb)

General U. S. Population 0.033 0.000216 0.032784 5 40 1100 All Infants (< 1 year old) 0.000339 0.032661 330 Children 1 2 years old 0.000427 0.032573 330 Children 3 5 years old 0.000486 0.032514 320 Children 6 12 years old 0.000373 0.032627 330 Youth 13 19 years old 0.000294 0.032706 980 Adults 20 49 years old 0.000182 0.032818 1100 Adults 50+ years old 0.000099 0.032901 1200 Females 13 49 years old 0.000177 0.032823 980 1 maximum water exposure ( mg/ kg/ day) = cPAD ( mg/ kg/ day)  food exposure ( mg/ kg/ day) 2 EECs generated using the GENEEC and SCI GROW models assuming a maximum seasonal application rate of 0.147 lb ai/ acre ( registered rice application scenario) 3 DWLOC = ( maximum water exposure) x ( body weigth) x ( 1000 µ g/ mg) ÷ ( liter/ day) Page 25 of 30 6.0 CUMULATIVE RISK Section 408( b)( 2)( D)( v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider " available information" concerning the cumulative effects of a particular pesticide's residues and " other substances that have a common mechanism of toxicity."

EPA does not have, at this time, available data to determine whether isoxadifen ethyl has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to isoxadifen ethyl and any other substances and isoxadifen ethyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that isoxadifen ethyl has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http:// www. epa. gov/ pesticides/ cumulative/.

7.0 OCCUPATIONAL EXPOSURE HED has previously evaluated the occupational exposures to isoxadifen ethyl resulting from the registered application scenarios for rice and corn ( D273606, T. Swackhammer, 26 Mar 2001). The following is a summary of this review. Based on the rice and corn use patterns, commercial handlers are expected to have short and intermediate term dermal and inhalation exposures. Growers are expected to have short term dermal and inhalation exposures. Workers entering fields following applications are anticipated to have short term dermal exposures. Since the dermal and inhalation endpoints are from the same toxicological study, these exposures were combined. The combined ( dermal and inhalation) short term and intermediate term MOEs, with the label required personal protective equipment, ranged from 2,100 21,000 and 510 5,000, respectively ( inhalation MOEs ranged from 7,800 92,000). Since the calculated MOEs are > 100, they do not exceed HED's level of concern.

Based on the proposed turf use pattern ( see Table 4), HED anticipates short term dermal and inhalation exposures to commercial mixer/ loaders supporting groundboom operations; to groundboom applicators; and to lawn care operators who mix, load, and apply the material. Workers entering fields following applications are anticipated to have short term dermal exposures. Since a common endpoint has been identified for short term dermal and inhalation exposures, these exposures were aggregated. The occupational exposure assessment is based on surrogate data from the following sources: ( 1) PHED, Version 1.1 ( August, 1998); ( 2) ORETF, study OMA002 " Exposure of Professional Lawn Care Workers During the Mixing and Loading of Dry and Liquid Formulations and the Liquid Application of Turf Pesticides Utilizing a Surrogate Compound" ( Bayer CropScience is a member of ORETF); and ( 3) the ARTF study ARF035 regarding turf farm re entry exposures. For a full review of the occupational exposure assessment see D295128 ( M. Dow, 22 Page 26 of 30 Oct 2003). 1 Integrated Report for Evaluation of Potential Exposures to Homeowners and Professional Lawn Care Operators Mixing, Loading, and Applying Granular and Liquid Pesticides to Residential Lawns. 12 March 1999. MRID No. 44972201.

Page 27 of 30 7.1 Handler Exposure Assumptions and Risk Assessments Groundboom Applications: The Pesticide Handlers Exposure Database ( PHED), jointly developed by Health Canada, the U. S. Environmental Protection Agency ( EPA), and Crop Life America ( CLA), was used to estimate the dermal and inhalation exposures resulting from the application of isoxadifen ethyl to sod farms and golf courses. The general procedure used to develop quantitative measures of exposure from this database is to create subsets of overall data based on the specific use pattern. Several such subsets are typically created; the most appropriate one is selected based on amount and quality of data and similarity to the use pattern of interest.

For initial assessments the PHED Surrogate Exposure Guide developed by the Agency ( August 1998) is used to estimate the dermal and inhalation exposure potentials. Because the formulation is a soluble concentrate, Scenario 3: All liquids, open mixing and loading is applicable to handle the mixing loading portion for the groundboom uses. Scenario 13: Groundboom application, open cab is used to address the application exposure.

The Scenario 3 dermal exposure potential for a mixer/ loader wearing the label required long sleeved shirt, long pants, and protective gloves is 0.023 mg/ lb ai and the inhalation exposure potential is 0.0012 mg/ lb ai. Because the toxicity endpoint is the same for both routes of exposure and the dermal absorption is assumed to be 100% in the absence of data, the combined dose is 0.0242 mg/ lb ai. The Scenario 13 dermal exposure potential for the groundboom applicator wearing long pants and a long sleeved shirt is 0.014 mg/ lb ai and the inhalation exposure potential is 0.00074 mg/ lb ai. The combined dose is 0.0147 mg/ lb ai.

The treatment of 80 acres/ day requires 3.2 lb a. i. The daily dose for a 70 kg individual and the resultant MOE based on the NOEL of 13.8 mg/ kg/ day is calculated as follows:

mixer/ loader groundboom application ( 80 acres/ day) dialy exposure estimate = 0.0242 mg/ lb ai x 3.2 lb ai/ day ÷ 70 kg = 0.0011 mg/ kg/ day MOE = 13.8 mg/ kg/ day ÷ 0.0011 mg/ kg/ day = 13,000 applicator groundboom application ( 80 acres/ day) daily exposure estimate = 0.0147 mg/ lb ai x 3.2 lb ai/ day ÷ 70 kg = 0.00067 mg/ kg/ day MOE = 13.8 mg/ kg/ day ÷ 0.00067 mg/ kg/ day = 21,000 Handspray Applications: The exposure to LCOs and other applicators applying isoxadifen ethyl to to residential lawns, park turf, golf course greens and tees, and similar sites by hand held spray gun application is based on exposure data developed by the ORETF. Aventis is a member of the ORETF. ORETF Study OMA0051 is an integrated report that contains ORETF Study OMA002 that specifically deals with LCO exposure. OMA002, Exposure of Professional Lawn Care Workers During the Mixing and Loading of Dry and Liquid Formulations and the Liquid Application of Turf Pesticides Utilising a Surrogate Compound, has also been submitted to the Agency by ORETF. The objective of the study was to obtain an assessment of the potential dermal and inhalation exposure to professionals applying liquid sprays to turf. 2 Determination of Dermal and Inhalation Exposure to Reentry Workers During Harvesting in Sod. 13 June 2001. MRID No. 45432303.

Page 28 of 30 Fifteen replications of LCOs mixing/ loading and applying flowable liquids by hand held spray guns were monitored. Dermal exposure was monitored using whole body dosimeters worn under long pants and long sleeved shirts, hand washes, and face wipes. Residues from the inner whole body dosimeters, the hands, and face were quantified to estimated actual dermal exposure. Inhalation exposure was monitored using personal air sampling pumps. Each replication consisted of the LCO handling approximately 2.3 kg ai during a work cycle that treated approximately 2.5 acres. The geometric mean dermal and inhalation exposures for an LCO mixing, loading, and applying a liquid formulation while wearing protective gloves, long pants, and a long sleeved shirt were 0.00511 mg/ kg/ lb ai and 0.000018 mg/ kg/ lb ai, respectively. The geometric mean LCO body weight of the 15 replications was 82.7 kg. The equivalent dermal and inhalation exposure in mg/ lb ai is 0.423 mg/ lb ai for dermal exposure and 0.0015 mg/ lb ai. The combined dose is 0.425 mg/ lb ai assuming 100% dermal absorption.

The combined dermal and inhalation exposure for a professional handspray application that includes mixing/ loading is 0.425 mg/ lb ai. The treatment of 5 acres/ day requires 0.2 lb a. i. The daily dose for a 70 kg individual and resultant MOE based on the NOEL of 13.8 mg/ kg/ day is calculated as follows:

mixer/ loader/ applicator hand spray application ( 5 acre/ day) daily exposure estimate = 0.425 mg/ lb ai x 0.2 lb ai/ day ÷ 70 kg = 0.0012 mg/ kg/ day MOE = 13.8 mg/ kg/ day ÷ 0.0012 mg/ kg/ day = 12,000 7.2 Post Application Exposures and Assumptions Sod Farms: The ARTED Task Force study ARF0352 and the resultant ARTF database transfer coefficients for sod are used in this assessment. ARF035 involved the application of a pesticide to 3.3 ha of bluegrass sod. Work functions involved the workers standing on the sod cutter beside the chute ( they worked in pairs, one on each side of the cutter). As the sod moved through the chute, the workers grabbed the sod, positioned it over the stack area, and dropped the sod on the ground to simulate dropping it onto a pallet. Workers were monitored on the second, third, and fourth days following the second application. Dermal exposure was monitored using whole body dosimeters placed under long pants and a long sleeved shirt. Face/ neck wipes and hand washes were also conducted. Inhalation exposure was monitored using personal air pumps drawing air at 2.0 litres/ minute. The TTRs were monitored using the ORETF SOP 10. E. The dosimeter was a 5570 cm2 cotton cloth. TTRs were collected 14 hours before the first application, as soon as possible after the first and second applications were dry, and on days 1, 2, 3, 4, 5, 6, 7, and 14 days after the second application. The three days of reentry occurred on days 2, 3, and 4 after the second application.

The day 0 TTRs after the second application averaged 0.00087 mg/ cm2. The application rate was 12.7 kg ai/ ha and the day 0 TTRs were 0.69% of the application rate. The TTRs from ARF035 is consistent with the TTRs established by the ORETF ( Evaluation of Transferable Turf Residue Data From Studies Conducted or Purchased by the ORETF, 31 Oct 2000). The day 0 TTR value expressed as a percentage of the application rate was 0.62% based on over 100 replications of data. The ORETF TTR data was not used for the post application lawn exposure assessment because the Jazzercise based TC of 14,500 cm2/ hr was not determined concurrently with the turf TTR data. 3 Determination of Dermal and Inhalation Exposure to Reentry Workers During Maintenance Activities on Golf Courses, 26 Oct 2001. MRID No. 4553010.

Page 29 of 30 EPA has expressed concern that the TC to TTR relationship may not be linear to permit extrapolation down to the ORETF TTRs of 0.62%. Because the sod TCs were determined concurrently with the TTR of 0.69% and this TTR is similar to the overall ORETF TTR estimate of 0.62%, the ORETF data can be used generically for isoxadifen ethyl use as a safener on sod. Based on the application rate of 45 g ai/ ha ( 0.45 mg/ cm2) and a day 0 TTR of 0.62% of the application rate, the day 0 isoxadifen ethyl TTR estimate is 0.0000028 mg/ cm2.

The ARTF database was used to obtain the TCs for use in calculating sod reentry exposures. The database was subset for crop equal to sod and activity, foliage density, and crop height equal to all. A total of eight post application activities are presented. Four activities ( fertilizing, roll harvesting, irrigation, and mechanical weeding) do not require TCs and are considered no contact activities. Three activities were clustered in cluster code DM and involved scouting, transplanting, and hand weeding. The DM activities were derived from ARTF study ARF 0463. Despite the clustering of these golf course activities in the ARTF database with sodfarms the work activities that were monitored are not representative of sod farm activities. The activities included the changing of cup hole locations on greens by driving a cup changer into the green and drawing out a sod plug, removing the plastic cup from the old hole and placing it in the new hole, and finally placing the sod plug in the old hole and tamping it down by hand. This activity is represented as transplanting in the cluster. Weeding by hand is represented by workers stooping or kneeling on the turf and using a weeding tool to remove goose grass from the turf. Such hand weeding is atypical on sod farms. The combined activities required five to seven hours. Because the DM TC is derived from dermal exposure monitored during activities that do not occur on sod farms, the TC of 19,700 cm2/ hr are not considered valid for sod farm post application exposure assessment.

The DH cluster activity of harvesting sod was obtained from the ARF035 study and is relevant to isoxadifen ethyl sod farm postapplication exposure. A TC of 6,180 cm2/ hr was established for sod harvesting. This harvesting TC is an upper bound estimate of TCs such as scouting and will be used to represent a full 8 hour workday. Based on a day 0 TTR of 0.0000028 mg/ cm2, a TC of 6,180 cm2/ hr, an 8 hour duration, and a 70 kg body weight, the daily dermal exposure from harvesting sod on day 0 is calculated as follows:

post application exposure sod farm daily exposure estimate= 0.0000028 mg/ cm2 x 6,180 cm2/ hr x 8 hr/ day ÷ 70 kg = 0.00020 mg/ kg/ day MOE = 13.8 mg/ kg/ day ÷ 0.002 mg/ kg/ day = 6900 The MOE of 6900 supports a sod farm restricted entry interval of 12 hours for harvesting.

Golf Course: The ARTF database was used to obtain the TCs for use in calculating golf course reentry exposures. The database was subset for crop equal to golf course and activity, foliage density, and crop height equal to all. A total of nine post application activities are presented. Five activities ( aerating, fertilizing, seeding, irrigation, and mechanical weeding) do not require TCs and are considered no contact activities. Four activities were clustered in cluster code DM and involved maintenance, scouting, transplanting, and hand weeding. The DM activities were derived from ARTF study ARF 046. The activities included the changing of cup hole locations on greens by Page 30 of 30 driving a cup changer into the green and drawing out a sod plug, removing the plastic cup from the old hole and placing it in the new hole, and finally placing the sod plug in the old hole and tamping it down by hand. Weeding by hand is represented by workers stooping or kneeling on the turf and using a weeding tool to remove goose grass from the turf. Finally, the workers were involved in mowing the tees, fairways, and greens. The combined activities required five to seven hours. The DM TC is 19,700 cm2/ hr. Based on a day 0 TTR of 0.0000028 mg/ cm2, a TC of 19,700 cm2/ hr and an eight hour exposure duration, the daily exposure and resultant MOE to a 70 kg golf course worker is calculated as follows:

post application exposure sod farm daily exposure estimate = 0.0000028 mg/ cm2 x 19,700 cm2/ hr x 8 hr/ day ÷ 70 kg = 0.0063 mg/ kg/ day MOE = 13.8 mg/ kg/ day ÷ 0.0063 mg/ kg/ day = 2200 The MOE of 2200 supports a non WPS reentry statement permitting maintenance activities after sprays have dried.

7.3 Restricted Entry Intervals ( REIs)

A 12 hour REI is appropriate for isoxadifen ethyl.

7.4 Incidents A search of OPP's REFS Incident Data Reporting System revealed no recorded incidents for isoxadifen ethyl.

8.0 TOXICOLOGICAL, RESIDUE CHEMISTRY, and OCCUPATIONAL/ RESIDENTIAL DATA DEFICIENCIES 8.1 Toxicology ° The lack of a 28 day inhalation toxicity study has been identified by HIARC as a data gap for isoxadifen ethyl. Based upon the low acute inhalation toxicity ( acute inhalation toxicity category IV), low vapor pressure ( 1.65 x 10  8 mm Hg), and since the inhalation MOEs resulting from the proposed turf use and the registered corn and rice uses were > 1000 ( 7,800 3,300,000; i. e. > 10x the LOC), HED will not require the submission of the 28 day inhalation study in support of the turf or rice/ corn petitions ( TXR No 0052240, M. Dow, 18 Nov 2003).

8.2 Residue Chemistry ° multiresidue testing of AE C637375 8.3 Occupational Exposure ° none cc: T. Bloem, PV Shah, Mark Dow RDI: RAB1 ( 12 Nov 2003) T. Bloem: 806R: CM# 2:( 703) 605 0217: 7509C: RAB1


[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Page 96163]
[FR Doc No: 2016-31504]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2016-0128]

Petition for Exemption; Summary of Petition Received; Skylift
Global, Inc.

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Title 14 of the Code of Federal
Regulations. The purpose of this notice is to improve the public's
awareness of, and participation in, the FAA's exemption process.
Neither publication of this notice nor the inclusion or omission of
information in the summary is intended to affect the legal status of
the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before January 18, 2017.

ADDRESSES: Send comments identified by docket number FAA-2015-7197
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Dan Ngo,<PHONE_NUMBER>, 800
Independence Avenue SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on December 21, 2016.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2015-7197.
    Petitioner: Skylift Global, Inc.
    Section(s) of 14 CFR Affected: Part 27, subpart B Sec. Sec.
61.23(a) and (c), 61.101(e)(4) and (5), 61.113(a) and (b), 61.315(a),
91.7(a), 91.119(c), 91.121, 91.151(a)(1) and (b), 91.405(a),
91.407(a)(1), 91.409(a)(1) and (2), 91.417(a) and (b)
    Description of Relief Sought: The petitioner is requesting an
amendment to Exemption No. 16683 in order to fly the Phase II UAS,
which can carry payloads over 200 pounds to fly in designated testing
areas.

[FR Doc. 2016-31504 Filed 12-28-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 170 (Friday, September 2, 2022)]
[Notices]
[Pages 54213-54214]
[FR Doc No: 2022-19017]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[FRL OP-OFA-033]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS)
Filed August 22, 2022 10 a.m. EST Through August 29, 2022 10 a.m. EST
Pursuant to 40 CFR 1506.9.

    Notice: Section 309(a) of the Clean Air Act requires that EPA make
public its comments on EISs issued by other Federal agencies. EPA's
comment letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20220121, Draft, USAF, AR, Beddown of a Foreign Military Sales
Pilot Training Center at Ebbing Air National Guard Base, Arkansas or
Selfridge Air National Guard Base, Michigan, Comment Period Ends: 10/
17/2022, Contact: David Martin<PHONE_NUMBER>.
EIS No. 20220122, Draft, CHSRA, CA, California High-Speed Rail
Authority Palmdale to Burbank Project Section: Draft Environmental
Impact Report/Environmental Impact Statement, Comment Period Ends: 11/
01/2022, Contact: Scott Rothenberg<PHONE_NUMBER>.
EIS No. 20220123, Final, NMFS, HI, Pacific Islands Aquaculture
Management Program, Review Period Ends: 10/03/2022, Contact: Tori
Spence McConell<PHONE_NUMBER>.

EIS No. 20220124, Final, FERC, KY, Texas Gas Henderson County Expansion
Project, Review Period Ends: 10/03/2022, Contact: Office of External
affairs<PHONE_NUMBER>.
EIS No. 20220125, Final Supplement, USN, AK, Gulf of Alaska Navy
Training Activities, Review Period Ends: 10/03/2022, Contact: Jennifer
Steele<PHONE_NUMBER>.
EIS No. 20220126, Final, FERC, CA, Lower Klamath Project, Review Period
Ends: 10/03/2022, Contact: Office of External Affairs<PHONE_NUMBER>.
EIS No. 20220127, Final, UDOT, UT, Little Cottonwood Canyon
Environmental Impact Statement; SR-210: Wasatch Boulevard to Alta,
Review Period Ends: 10/17/2022, Contact: Josh Van Jura<PHONE_NUMBER>.
EIS No. 20220128, Final, RUS, WI, Badger State Solar Project, Review
Period Ends: 10/03/2022, Contact: Peter Steinour<PHONE_NUMBER>.
EIS No. 20220129, Final Supplement, DHS, DC, ADOPTION--St. Elizabeth's
Master Plan Amendment 2, Contact: Sarah Koeppel<PHONE_NUMBER>.

    The Department of Homeland Security (DHS) has adopted the General
Service Administration's Final EIS No. 20200173, filed 8/20/2020 with
the Environmental Protection Agency. The DHS was a cooperating agency
on this project. Therefore, republication of the document is not
necessary under Section 1506.3(b)(2) of the CEQ regulations.

EIS No. 20220130, Draft, BOEM, RI, Revolution Wind Farm and Revolution
Wind Export Cable Project, Comment Period Ends: 10/17/2022, Contact:
Trevis Olivier<PHONE_NUMBER>.
EIS No. 20220131, Final, BIA, NM, Navajo Nation Integrated Weed
Management Plan, Review Period Ends: 10/04/2022, Contact: Leonard Notah
508-863-8287.

    Dated: August 29, 2022.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2022-19017 Filed 9-1-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 145 (Tuesday, July 29, 2014)]
[Notices]
[Pages 44041-44042]
[FR Doc No: 2014-17710]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Nonprescription Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Nonprescription Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on September 4, 2014, from
8 a.m. to 5 p.m. and September 5, 2014, from 8 a.m. to 12 noon.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Cindy Hong, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The committee will discuss the scope of safety testing that
should be required for sunscreen active ingredients to be marketed in
U.S. over-the-counter (OTC) sunscreen products. This discussion will
take into consideration that sunscreens are typically used chronically
in individuals over the age of 6 months to help prevent skin cancer and
skin aging. The need for various types of safety data, including
clinical data and nonclinical data, will be discussed.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the

appropriate advisory committee meeting link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
August 19, 2014. Oral presentations from the public will be scheduled
between approximately 3:25 p.m. and 5 p.m. on September 4, 2014. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
August 11, 2014. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by August 12, 2014.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Cindy Hong at least
7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: July 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17710 Filed 7-28-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 8 (Wednesday, January 13, 2021)]
[Notices]
[Page 2674]
[FR Doc No: C1-2020-28064]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0161]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Export of Food and
Drug Administration-Regulated Products: Export Certificates

Correction

    In notice document 2020-28064 appearing on pages 83091-83092 in the
issue of Monday, December 21, 2020, make the following correction:
    On page 83091, in the second column, in the DATES section, change
``January 20, 2021'' to read ``January 21, 2021.''

[FR Doc. C1-2020-28064 Filed 1-12-21; 8:45 am]
BILLING CODE 1301-00-D