[Federal Register Volume 79, Number 163 (Friday, August 22, 2014)]
[Notices]
[Pages 49833-49834]
[FR Doc No: 2014-19967]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2014-0047; Notice 2]

Mitsubishi Motors North America, Inc., Grant of Petition for
Decision of Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Grant of Petition.

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SUMMARY: Mitsubishi Motors North America, Inc. (MMNA) has determined
that certain model year (MY) 2014 Mitsubishi Outlander Sport
multipurpose passenger vehicles (MPV) do not fully comply with
paragraph S6 of Federal Motor Vehicle Safety Standard (FMVSS) No. FMVSS
205, Glazing Materials. MMNA has filed an appropriate report dated
April 3, 2014, pursuant to 49 CFR part 573, Defect and Noncompliance
Responsibility and Reports.

ADDRESSES: For further information on this decision contact Mr. Luis
Figueroa, Office of Vehicle Safety Compliance, the National Highway
Traffic Safety Administration (NHTSA), telephone<PHONE_NUMBER>,
facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    I. MMNA's Petition: Pursuant to 49 U.S.C. 30118(d) and 30120(h) and
the rule implementing those provisions at 49 CFR part 556, MMNA has
petitioned for an exemption from the notification and remedy
requirements of 49 U.S.C. Chapter 301 on the basis that this
noncompliance is inconsequential to motor vehicle safety.
    Notice of receipt of the petition was published, with a 30-day
public comment period, on June 6, 2014 in the Federal Register (79 FR
32814). One comment was received from Joseph Poley. Mr. Poley stated
his belief that in the notice of receipt NHTSA incorrectly referred to
the subject glazing as ``laminated'' when it was actually ``tempered.''
Mr. Poley is correct. In its petition, MMNA referred to the glazing as
``tempered.'' NHTSA inadvertently referred to the glazing as
``laminated'' in the notice of receipt. To view the petition, the
comment, and all supporting documents log onto the Federal Docket
Management System (FDMS) Web site at: http://www.regulations.gov/. Then
follow the online search instructions to locate docket number ``NHTSA-
2014-0047.''
    II. Vehicles Involved: Affected are approximately 311 MY 2014
Mitsubishi Outlander Sport MPVs manufactured from February 12, 2014
through February 21, 2014 that contained mislabeled tempered rear door
glazing manufactured by Pilkington North America, Inc. (PNA).
    III. Noncompliance: MMNA explains that the noncompliance is that
the tempered rear door glazing in the subject vehicles was labeled with
the incorrect manufacturer's model number. Specifically, the glazing
was labeled with PNA model number ``M-131'' instead of the correct
model number ``M-129.''
    IV. Rule Text: FMVSS No. 205 incorporates ANSI Z26.1-1996 and other
industry standards in paragraph S.5.1 by reference. Paragraph S6 of
FMVSS No. 205 specifically requires manufacturers to mark the glazing
material in accordance with Section 7 of ANSI Z26.1 and to add other
markings required by NHTSA. With respect to the subject noncompliance,
Section 7 of ANSI Z26.1-1996 specifies that in addition to the item of
glazing number and other required markings, the manufacturer shall
include a model number which will identify the type of construction of
the glazing material.
    V. Summary of MMNA's Analyses: MMNA stated its belief that the
subject noncompliance relates solely to the product monograms or
markings, specifically the use of model number ``M-131'' instead of
``M-129''. These rear door windows otherwise meet all other marking and
performance requirements of FMVSS No. 205 and ANSI Z26.1. MMNA also
stated its belief that NHTSA previously noted that ``The stated
purposes of FMVSS No. 205 are to reduce injuries resulting from impact
to glazing surfaces, to ensure a necessary degree of transparency in
motor vehicle windows for driver visibility, and to minimize the
possibility of occupants being thrown through the vehicle windows in
collisions'' (64 FR 70116). MMNA believes that because the affected
glazing fully meets all of the applicable performance requirements of
FMVSS No. 205 that the absence of the correct model number on the
glazing has no effect upon the ability of the glazing to satisfy those
purposes and thus perform in the manner intended by FMVSS No. 205.
    MMNA also stated its belief that NHTSA has previously granted other
petitions that MMNA believes were similar to the subject petition.
    MMNA is not aware of any crashes, injuries, customer complaints, or
field reports associated with this condition.
    MMNA has additionally informed NHTSA that it has corrected the

noncompliance so that all future production vehicles will comply with
FMVSS No. 205.
    In summation, MMNA believes that the described noncompliance of the
subject vehicles is inconsequential to motor vehicle safety, and that
its petition, to exempt from providing recall notification of
noncompliance as required by 49 U.S.C. 30118 and remedying the recall
noncompliance as required by 49 U.S.C. 30120 should be granted.
    NHTSA Decision:
    NHTSA Analysis: FMVSS No. 205 specifies labeling and performance
requirements for automotive glazing. FMVSS No. 205 incorporates ANSI
Z26.1 (1996) and other industry standards by reference (S.5.1).
Paragraph S6 of FMVSS No. 205 requires manufacturers to mark glazing
material in accordance with Section 7 of ANSI Z26.1 (1996) and to add
other specific markings required by NHTSA. Section 7 of ANSI Z26.1
(1996) specifies that in addition to other markings required, the
manufacturer shall include a model number which will identify the type
of construction of the glazing material.
    According to the petition, the nature of the noncompliance is the
incorrect model number as required in FMVSS No. 205 and ANSI Z26.1
(1996). Mitsubishi has certified that the window complies with all
other safety performance requirements of FMVSS No. 205. NHTSA believes
that the incorrect model number is inconsequential to vehicle safety
since the unmarked glazing complies with the other labeling and
performance requirements of the standard. Also, NHTSA believes that the
noncompliance would not result in inadvertent replacement of the
windows with the wrong glazing because the population with the labeling
noncompliance will not be available as replacement/service parts.
Mitsubishi has returned all affected glazing to the glazing
manufacturer, with the exception of the 311 glazing units that were
installed in vehicles destined to be sold in the USA, and the
manufacturer scrapped the remainder of the affected population.
    NHTSA Decision: In consideration of the foregoing, NHTSA has
decided that MMNA has met its burden of persuasion that the FMVSS No.
205 noncompliance is inconsequential to motor vehicle safety.
Accordingly, MMNA's petition is hereby granted and MMNA is exempted
from the obligation of providing notification of, and a remedy for,
that noncompliance under 49 U.S.C. 30118 and 30120.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, this decision
only applies to the subject noncompliant vehicles that MMNA no longer
controlled at the time it determined that the noncompliance existed.
However, the granting of this petition does not relieve vehicle
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant vehicles under their control after MMNA
notified them that the subject noncompliance existed.

    Authority: 49 U.S.C. 30118, 30120: Delegations of authority at
49 CFR 1.95 and 501.8.

Jeffrey M. Giuseppe,
Acting Director Office of Vehicle Safety Compliance.
[FR Doc. 2014-19967 Filed 8-21-14; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: December 10, 2007 (Volume 72, Number 236)]
[Proposed Rules]
[Page 69639-69640]
[DOCID:fr10de07-32]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2007-29057; Airspace Docket 07-ASO-20]

Proposed Amendment of Class D Airspace; Jacksonville NAS, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

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SUMMARY: This notice proposes to amend the Class D airspace at
Jacksonville Naval Air Station (NAS), FL. As a result of an evaluation,
it has been determined the Class D airspace should be extended to join
the Jacksonville Cecil Field Class D airspace area. Additional
controlled airspace is necessary for the safety and management of
Instrument Flight Rules (IFR) operations at Jacksonville NAS.

DATES: Comments must be received on or before January 24, 2008.

ADDRESSES: Send comments on this proposal to the Docket Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
1200 New Jersey Avenue, SE., West Building, Ground Floor, Room W12-140,
Washington, DC 20590; telephone: 1-800-647-5527. You must identify the
docket number FAA-2007-29057/Airspace Docket No. 07-ASO-20, at the
beginning of your comments. You may also submit comments on the
Internet at http://www.regulations.gov. You may review the public

docket containing the proposal, any comments received, and any final
disposition in person in the Dockets Office (see ADDRESSES section for
address and phone number) between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    An informal docket may also be examined during normal business
hours at the office of the Eastern Service Center, Federal Aviation
Administration, Room 210, 1701 Columbia Avenue, College Park, Georgia
30337.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, System Support,
Eastern Service Center, Federal Aviation Administration, P.O. Box
20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2007-29057/
Airspace Docket No. 07-ASO-20.'' The postcard will be date/time stamped
and returned to the commenter. All communications received before the
specified closing date for comments will be considered before taking
action on the proposed rule. The proposal contained in this notice may
be changed in light of the comments received. A report summarizing each
substantive public contact with FAA personnel concerned with this
rulemaking will be filed in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov Recently published rulemaking documents can also be accessed through the FAA's Web page at http://.

www.faa.gov or the Federal Register's Web page at http://www.gpoaccess.gov/fr/index.html.
 Persons interested in being placed on

a mailing list for future NPRMs should contact the FAA's Office of
Rulemaking,<PHONE_NUMBER>, to request a copy of Advisory Circular No.
11-2A, Notice of Proposed Rulemaking Distribution System, which
describes the application procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to amend Class D airspace at Jacksonville
NAS, FL. The current Class D airspace supporting IFR operations must be
extended to contain operations at Jacksonville NAS. This proposed
action would provide the additional controlled airspace, extending
upward from the surface to support IFR operations between Jacksonville
NAS and Jacksonville Cecil Field. Class D airspace designations are
published in Paragraph 5000 of FAA Order 7400.9R, dated August 15,
2007, and effective September 15, 2007, which is incorporated by
reference in 14 CFR 71.1. The Class D airspace designation listed in
this document would be published subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in

Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it has been determined the Class D airspace at Jacksonville Naval
Air Station (NAS), FL should be extended to join the Jacksonville Cecil
Field Class D airspace area.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9R, Airspace Designations and
Reporting Points, dated August 15, 2007, and effective September 15,
2007, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ASO FL D Jacksonville NAS, FL [Revised]

Jacksonville NAS, FL
    (Lat. 30[deg]14'09'' N, long. 81[deg]40'50'' W)
Jacksonville TACAN
    (Lat. 30[deg]14'05'' N, long. 81[deg]40'30'' W)

    That airspace extending upward from the surface, to and
including 2,600 feet MSL, within a 5.3-mile radius of Jacksonville
NAS and within 1 mile north and 2.5 miles south of the Jacksonville
TACAN 270[deg] radial, extending from the 5.3-mile radius to 6.5
miles west of the TACAN; excluding that airspace within the
Jacksonville Cecil Field Class D airspace area. This Class D
airspace area is effective during the specific days and times
established in advance by a Notice to Airmen. The effective days and
times will thereafter be continuously published in the Airport/
Facility Directory.
* * * * *

    Issued in College Park, Georgia, on November 9, 2007.
Barry A. Knight,
Acting Manager, System Support Group, Eastern Service Center.
[FR Doc. 07-5985 Filed 12-7-07; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register: March 16, 2009 (Volume 74, Number 49)]
[Notices]
[Page 11149-11151]
[DOCID:fr16mr09-107]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59553; File No. SR-ISE-2009-11]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Enable the Listing and Trading of Options on Managed Fund
Shares

March 10, 2009.
    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 March 3, 2009, the International Securities Exchange, LLC (``ISE''
or ``Exchange'') 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
Exchange filed the proposal pursuant to Section 19(b)(3)(A) of the Act
\3\ and Rule 19b-4(f)(6) thereunder,\4\ which renders the proposal
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 502(h) to enable the listing
and trading of options on Managed Fund Shares. The text of the proposed
rule change is available on the Exchange's Web site http://www.ise.com,
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 self-regulatory organization 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 revise ISE Rule 502
to enable the listing and trading of options on managed fund shares
(``Managed Fund Shares'') that are listed and traded on a national
securities exchange and are considered to be an ``NMS Stock'' (as
defined in Rule 600 of Regulation NMS under the Securities and Exchange
Act of 1934 (the ``Act'')).
    Managed Fund Shares represent an interest in a registered
investment company (``Investment Company'') organized as an open-end
management investment company or similar entity. Unlike traditional
exchange traded funds Managed Fund Shares are actively managed. Managed
Fund Shares, although, based upon a publicly disclosed portfolio of
securities, each trade as a single exchange-listed equity security.
    Accordingly, the rules pertaining to the listing and trading of
standardized equity options will apply to Managed Fund Shares.

Listing Criteria

    The Exchange will consider listing and trading options on Managed
Fund Shares provided the Managed Fund Shares meet (1) the criteria for
underlying securities set forth in ISE Rule 502(a) and (b) \5\, or the
Managed Fund Shares are available for creation and redemption each
business day as set forth in ISE Rule 502(h)(A)(ii).
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    \5\ See ISE Rule 502(a) and (b), which collectively require
minimum requirements for the underlying security that include, but
are not limited to: (1) The security be registered and be an ``NMS
stock'' as defined in Rule 600 of Regulation NMS under the Exchange
Act; (2) the security be characterized by a substantial number of
outstanding shares that are widely held and actively traded; (3)
7,000,000 underlying shares, (4) 2,000 shareholders; and (4) trading
volume of 2,400,000 shares in the preceding 12 months.
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    The Exchange proposes that Managed Fund Shares deemed appropriate
for options trading represent an interest in an open-end management
investment company or similar entity, as described below:
     Managed Fund Shares are securities that represents an
interest in a registered investment company (``Investment Company'')
organized as an open-end management investment company or similar
entity, that invests in a portfolio of securities selected by the
Investment Company's investment adviser consistent with the Investment
Company's investment objectives and

policies, which is issued in a specified aggregate minimum number in
return for a deposit of a specified portfolio of securities and/or a
cash amount with a value equal to the next determined net asset value
(``NAV''), and when aggregated in the same specified minimum number,
may be redeemed at a holder's request, which holder will be paid a
specified portfolio of securities and/or cash with a value equal to the
next determined NAV.

Continued Listing Requirements

    Options on Managed Fund Shares will be subject to all Exchange
rules governing the trading of equity options and furthermore, the
rules pertaining to position and exercise limits \6\ or margin \7\
shall apply. The current continuing or maintenance listing standards
for options traded on ISE will continue to apply.
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    \6\ Pursuant to ISE Rule 412(a)(1) and 412(d), Managed Fund
Shares are subject to the same position limits applicable to options
on stocks and Exchange-Traded Fund Shares. ISE Rule 414 stipulates
that exercise limits for options on stocks and other securities,
including Managed Fund Shares shall be the same as the position
limits applicable under ISE Rule 412.
    \7\ See ISE Rules 1200--1204, the Exchange's rules governing
margin.
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    The Exchange will utilize its existing surveillance procedures
applicable to options on exchange traded funds (which will include
Managed Fund Shares) to monitor trading. In addition, the Exchange will
implement any new surveillance procedures it deems necessary to
effectively monitor the trading of options on Managed Fund Shares,
including adequate comprehensive surveillance sharing agreements
(``CSSA'') with markets trading in non-U.S. components,\8\ as
applicable. Also, the Exchange may obtain trading information via the
Intermarket Surveillance Group (``ISG'') \9\ from other exchanges who
are members or affiliates of the ISG. ISE represents that these
procedures will be adequate to properly monitor Exchange trading of
options on these the securities and to deter and detect violations of
Exchange rules.
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    \8\ See ISE Rule 502(h)(B), the Exchange's rule governing the
applicable CSSA requirements for options on exchange-traded funds.
The Exchange notes that any non-U.S. component securities (including
fixed-income) in an index or portfolio of securities on which the
Fund Shares are based that are not subject to comprehensive
surveillance agreements may in the aggregate represent an amount
equal to 50% of the weight of the index or portfolio.
    \9\ A complete list of the current members of the ISG is
available at http://www.isgportal.org.
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2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(5) that an exchange have rules that are
designed to promote just and equitable principles of trade, and to
remove impediments to and perfect the mechanism for a free and open
market and a national market system, and in general, to protect
investors and the public interest. The Exchange believes that proposed
rules applicable to trading pursuant to generic listing and trading
criteria, together with the Exchange's surveillance procedures
applicable to trading in the securities covered by the proposed rules,
serve to foster investor protection.

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

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

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

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

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

    The Exchange has designated the proposed rule change as one that:
(i) Does not significantly affect the protection of investors or the
public interest; (ii) does not impose any significant burden on
competition; and (iii) by its terms, does not become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest. Additionally, the Exchange provided the
Commission with written notice of its intention to file the proposed
rule change at least five business days before its filing. Therefore,
the foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \10\ and Rule 19b-4(f)(6) thereunder.\11\ The
proposed rule change will permit the Exchange to trade options on
Managed Fund Shares thus providing investors additional opportunities
to hedge their positions. Further, this proposed rule change is
identical to one recently approved by the Commission.\12\ For the
foregoing reasons, this rule filing qualifies for immediate
effectiveness as a ``non-controversial'' rule change under paragraph
(f)(6) of Rule 19b-4 of the Act.
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ See Securities Exchange Act Release Nos. 59004 (November
24, 2008), 73 FR 72882 (December 1, 2008) (SR-NYSEArca-2008-108);
59006 (November 24, 2008), 73 FR 72879 (SR-NYSEALTR-2008-08).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2009-11 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2009-11. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m.

Copies of such filing also will be available for inspection and copying
at the principal office of the Exchange. All comments received will be
posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-ISE-2009-11 and should be submitted on
or before April 6, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-5594 Filed 3-13-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Notices]
[Pages 74181-74184]
[FR Doc No: 2015-30090]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76501; File No. SR-ISE-2015-40]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Amend the Schedule of Fees

November 20, 2015.
    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 November 6, 2015, the International Securities Exchange, LLC
(the ``Exchange'' or ``ISE'') 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 self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    ISE proposes to amend the Schedule of Fees as described in more
detail below. The text of the proposed rule change is available on the
Exchange's Internet Web site at http://www.ise.com, 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 self-regulatory organization 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 amend the Schedule of
Fees to offer a one (1) month free trial of the

ISE Open/Close Trade Profile End of Day market data offering to all
members and non-members who have never before subscribed to the
offering and to remove the discounts offered to subscribers of multiple
market data feeds.
ISE Open/Close Trade Profile
    ISE currently sells a market data offering comprised of the entire
opening and closing trade data of ISE listed options of both customers
and firms, referred to by the Exchange as the ISE Open/Close Trade
Profile. The ISE Open/Close Trade Profile offering is subdivided by
origin code (i.e., customer or firm) and the customer data is then
further subdivided by order size. The volume data is summarized by day
and series (i.e., symbol, expiration date, strike price, call or put).
The ISE Open/Close Trade Profile enables subscribers to create their
own proprietary put/call calculations. The data is compiled and
formatted by ISE as an end of day file (``ISE Open/Close Trade Profile
End of Day''). This market data offering is currently available to both
members and non-members on an annual subscription basis. The current
subscription rate for both members and non-members is $750 per month
with an annual subscription.
    The Exchange now proposes to amend its Schedule of Fees to offer a
one (1) month free trial of the ISE Open/Close Trade Profile End of Day
market data offering to all members and non-members that have never
before subscribed to the offering. This will give potential subscribers
the ability to use and test the data offering before signing up for an
annual subscription.
Multi-Fee Discount
    The Exchange currently offers five real-time market data feed
offerings.\3\ In order to encourage subscriptions to multiple market
data feeds, ISE adopted a multi-product subscription discount, which
offers a ten percent (10%) discount for subscribers who subscribe to
two feeds and twenty percent (20%) discount for subscribers who
subscribe to three feeds.\4\ The Exchange now proposes to remove the
discounts for subscribers of multiple feeds.
---------------------------------------------------------------------------

    \3\ The market data feeds are: Real[hyphen]time Depth of Market
Raw Data Feed, ISE Order Feed, ISE Top Quote Feed, ISE Spread Feed,
and ISE Implied Volatility and Greeks Feed.
    \4\ See Securities Exchange Act Release No. 34-65002 (August 1,
2011), 76 FR 47630 (August 5, 2011) (SR-ISE-2011-50).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\5\ in general, and Section
6(b)(4) of the Act,\6\ in particular, in that 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.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f.
    \6\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    In particular, the Exchange believes the proposed free trial is
reasonable and equitable because it gives potential subscribers the
ability to use and test the ISE Open/Close Trade Profile End of Day
offering prior to committing to an annual subscription. Furthermore,
the Exchange believes that the proposed free trial is not unfairly
discriminatory because it is available to all similarly-situated market
participants--members and non-members who have never subscribed to the
market data offering. Similarly, the removal of the multi-product
subscription discount is also reasonable and equitable because the ISE
believes the discount is no longer necessary to encourage multiple
subscriptions. Further, the Exchange believes that the proposed removal
of the discount is not unfairly discriminatory because it applies to
all members and non-members who are subscribers to the feeds.

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

    In accordance with Section 6(b)(8) of the Act,\7\ the Exchange does
not believe that the proposed rule change will impose any burden on
intermarket or intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. First, the
proposed free trial does not affect competition because it is designed
to give potential subscribers the ability to use and test the ISE data
offering prior to committing to an annual subscription. Next, the
removal of the multi-product, market data discount reflects the intense
competition among exchanges and the cost of producing market data as
further described below.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

    Notwithstanding its determination that the Commission may rely upon
competition to establish fair and equitably allocated fees for market
data, the NetCoaltion [sic] court found that the Commission had not, in
that case, compiled a record that adequately supported its conclusion
that the market for the data at issue in the case was competitive. The
Exchange believes that a record may readily be established to
demonstrate the competitive nature of the market in question.
    For the reasons discussed above, the Exchange believes that the
Dodd-Frank Act amendments to Section 19 materially alter the scope of
the Commission's review of future market data filings, by creating a
presumption that all fees may take effect immediately, without prior
analysis by the Commission of the competitive environment. Even in the
absence of this important statutory change, however, the Exchange
believes that a record may readily be established to demonstrate the
competitive nature of the market in question.
    There is intense competition between exchanges that provide
transaction execution and routing services and proprietary data
products. Transaction execution and proprietary data products are
complementary in that market data is both an input and a byproduct of
the execution service. In fact, market data and trade execution are a
paradigmatic example of joint products with joint costs. The decision
whether and on which exchange to post an order will depend on the
attributes of the exchange where the order can be posted, including the
execution fees, data quality and price and distribution of its data
products. Without the prospect of a taking order seeing and reacting to
a posted order on a particular exchange, the posting of the order would
accomplish little. Without trade executions, exchange data products
cannot exist. Data products are valuable to many end users only insofar
as they provide information that end users expect will assist them or
their customers in making trading decisions.
    The costs of producing market data include not only the costs of
the data distribution infrastructure, but also the costs of designing,
maintaining, and operating the exchange's transaction execution
platform and the cost of regulating the exchange to ensure its fair
operation and maintain investor confidence. The total return that an
exchange earns reflects the revenues it receives from both products and
the joint costs it incurs. Moreover, an exchange's customers view the
costs of transaction executions and of data as a unified cost of doing
business with the exchange. A broker-dealer will direct orders to a
particular exchange only if the expected revenues from executing trades
on the exchange exceed net transaction execution costs and the cost of
data that the broker-dealer chooses to buy to support its trading
decisions (or those of its customers). The choice of data products is,
in turn, a product of the value of the products in making profitable
trading decisions. If the cost of the product exceeds its expected

value, the broker-dealer will choose not to buy it.
    Moreover, as a broker-dealer chooses to direct fewer orders to a
particular exchange, the value of the product to that broker-dealer
decreases, for two reasons. First, the product will contain less
information, because executions of the broker-dealer's orders will not
be reflected in it. Second, and perhaps more important, the product
will be less valuable to that broker-dealer because it does not provide
information about the venue to which it is directing its orders. Data
from the competing venue to which the broker-dealer is directing orders
will become correspondingly more valuable. Thus, a super-competitive
increase in the fees charged for either transactions or data has the
potential to impair revenues from both products. ``No one disputes that
competition for order flow is `fierce'.'' \8\ However, the existence of
fierce competition for order flow implies a high degree of price
sensitivity on the part of broker-dealers with order flow, since they
may readily reduce costs by directing orders toward the lowest-cost
trading venues. A broker-dealer that shifted its order flow from one
platform to another in response to order execution price differentials
would both reduce the value of that platform's market data and reduce
its own need to consume data from the disfavored platform. Similarly,
if a platform increases its market data fees, the change will affect
the overall cost of doing business with the platform, and affected
broker-dealers will assess whether they can lower their trading costs
by directing orders elsewhere and thereby lessening the need for the
more expensive data.
---------------------------------------------------------------------------

    \8\ NetCoalition, at 24.
---------------------------------------------------------------------------

    Analyzing the cost of market data distribution in isolation from
the cost of all of the inputs supporting the creation of market data
will inevitably underestimate the cost of the data. Thus, because it is
impossible to create data without a fast, technologically robust, and
well-regulated execution system, system costs and regulatory costs
affect the price of market data. It would be equally misleading,
however, to attribute all of the exchange's costs to the market data
portion of an exchange's joint product. Rather, all of the exchange's
costs are incurred for the unified purposes of attracting order flow,
executing and/or routing orders, and generating and selling data about
market activity. The total return that an exchange earns reflects the
revenues it receives from the joint products and the total costs of the
joint products.
    Competition among exchanges can be expected to constrain the
aggregate return each exchange earns from the sale of its joint
products, but different exchanges may choose from a range of possible,
and equally reasonable, pricing strategies as the means of recovering
total costs. For example, some exchanges may choose to pay rebates to
attract orders, charge relatively low prices for market information (or
provide information free of charge) and charge relatively high prices
for accessing posted liquidity. Other exchanges may choose a strategy
of paying lower rebates (or no rebates) to attract orders, setting
relatively high prices for market information, and setting relatively
low prices for accessing posted liquidity. In this environment, there
is no economic basis for regulating maximum prices for one of the joint
products in an industry in which suppliers face competitive constraints
with regard to the joint offering.
    The market for market data products is competitive and inherently
contestable because there is fierce competition for the inputs
necessary to the creation of proprietary data and strict pricing
discipline for the proprietary products themselves. Numerous exchanges
compete with each other for listings, trades, and market data itself,
providing virtually limitless opportunities for entrepreneurs who wish
to produce and distribute their own market data. This proprietary data
is produced by each individual exchange.
    Market data vendors provide another form of price discipline for
proprietary data products because they control the primary means of
access to end users. Vendors impose price restraints based upon their
business models. For example, vendors such as Bloomberg and Reuters
that assess a surcharge on data they sell may refuse to offer
proprietary products that end users will not purchase in sufficient
numbers. Internet portals, such as Google, impose a discipline by
providing only data that will enable them to attract ``eyeballs'' that
contribute to their advertising revenue. Retail broker-dealers, such as
Schwab and Fidelity, offer their customers proprietary data only if it
promotes trading and generates sufficient commission revenue. Although
the business models may differ, these vendors' pricing discipline is
the same: they can simply refuse to purchase any proprietary data
product that fails to provide sufficient value. The Exchange and other
producers of proprietary data products must understand and respond to
these varying business models and pricing disciplines in order to
market proprietary data products successfully.

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

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act,\9\ and subparagraph (f)(2) of Rule 19b-4
thereunder,\10\ because it establishes a due, fee, or other charge
imposed by ISE.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \10\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2015-40 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2015-40. This file
number should be included on the subject line if email is used. To help
the Commission process and review your

comments more efficiently, please use only one method. The Commission
will post all comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent
amendments, all written statements with respect to the proposed rule
change that are filed with the Commission, and all written
communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for Web site viewing and printing in the Commission's Public
Reference Room, 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
such filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-ISE-2015-40, and should be submitted on or before
December 18, 2015.

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

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

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-30090 Filed 11-25-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: June 16, 2009 (Volume 74, Number 114)]
[Notices]
[Page 28588-28589]
[DOCID:fr16jn09-102]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2000-7257; Notice No. 53]

Railroad Safety Advisory Committee; Notice of Meeting

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Announcement of Railroad Safety Advisory Committee (RSAC)
meeting.

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

SUMMARY: FRA announces the thirty-ninth meeting of the RSAC, a Federal
advisory committee that develops railroad safety regulations through a
consensus process. The RSAC meeting

topics will include opening remarks from the FRA Administrator and
presentations on the Rail Safety Improvement Act of 2008 (RSIA)
Hazardous Materials Personal Protective Equipment Initiative, RSIA
Highway-Rail Grade Crossings and Trespass Initiatives, and RSIA
forthcoming rulemaking regarding maintenance-of-way employees. Status
reports will be provided by the Passenger Safety, Track Safety
Standards, and Medical Standards Working Groups. Status updates will be
provided on the RSIA Positive Train Control Task, Hours of Service
Task, and the Railroad Bridge Task. The Committee may also be asked to
accept another RSIA-mandated task concerning critical incident
programs. This agenda is subject to change, including the possible
addition of further proposed tasks under the RSIA.

DATES: The meeting of the RSAC is scheduled to commence at 9:30 a.m. on
Thursday, June 25, 2009, and will adjourn by 4:30 p.m.

ADDRESSES: The RSAC meeting will be held at the Marriott Washington,
Wardman Park Hotel, 2660 Woodley Road, NW., Washington, DC 20008. The
meeting is open to the public on a first-come, first-served basis, and
is accessible to individuals with disabilities. Sign and oral
interpretation can be made available if requested 10 calendar days
before the meeting.

FOR FURTHER INFORMATION CONTACT: Larry Woolverton, RSAC Administrative
Officer/Coordinator, FRA, 1200 New Jersey Avenue, SE., Mailstop 25,
Washington, DC 20590,<PHONE_NUMBER>; or Grady Cothen, Deputy Associate
Administrator for Safety, FRA, 1200 New Jersey Avenue, SE., Mailstop
25, Washington, DC 20590,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Pursuant to Section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463), FRA is giving notice of a
meeting of the RSAC. The RSAC was established to provide advice and
recommendations to FRA on railroad safety matters. The RSAC is composed
of 54 voting representatives from 31 member organizations, representing
various rail industry perspectives. In addition, there are non-voting
advisory representatives from the agencies with railroad safety
regulatory responsibility in Canada and Mexico, the National
Transportation Safety Board, and the Federal Transit Administration.
The diversity of the Committee ensures the requisite range of views and
expertise necessary to discharge its responsibilities. See the RSAC Web
site for details on pending tasks at: http://rsac.fra.dot.gov/. Please
refer to the notice published in the Federal Register on March 11, 1996
(61 FR 9740), for additional information about the RSAC.

    Issued in Washington, DC on June 10, 2009.
John Leeds,
Director, Office of Safety Analysis.
[FR Doc. E9-14123 Filed 6-15-09; 8:45 am]

BILLING CODE 4910-06-P


Data Requirement:				PMRA Data Code      	{............}
                        EPA DP Barcode		461050
                        OECD Data Point	{............}
                        EPA MRID 			51398105
                        EPA Guideline		850.1075

Test material:	DACTHAL W-75 (ai: Dacthal)		Purity:	74.6%
Common name:	DCPA
Chemical name:	IUPAC: Not reported
            CAS name: Not reported
            CAS No.: Not reported
            Synonyms: Chlorthal-dimethyl

Primary Reviewer:	Elizabeth Krupka							Signature:
Environmental Scientist, CDM/CSS-Dynamac JV				Date:   04/02/2021
Secondary Reviewer:  Julie Burns  							Signature:
Environmental Scientist, CDM/CSS-Dynamac JV				Date:  04/14/2021

Primary Reviewer:	Christina M. Wendel						Signature:
EPA/OPP/EFED/ERB2/Biologist 								Date: 12/02/2021

Secondary Reviewer(s): Michael Wagman						Signature:
EPA/OPP/EFED/ERB2/Senior Scientist						Date: 12/02/2021

Reference/Submission No.:  {.....................}

Company Code 		{............}	[For PMRA]
Active Code			{............}	[For PMRA]
Use Site Category:	{............}	[For PMRA]
EPA PC Code 		078701

Date Evaluation Completed: 02-12-2021

CITATION: Manson, P.S. 2004. DACTHAL W-75: Acute toxicity to Oncorhynchus mykiss. Study conducted by Covance Laboratories Ltd., North Yorkshire, England. Study no. 1708/036. Study sponsored by AMVAC Chemical UK Ltd., Surrey, England. Study initiated on September 19, 2003 and completed on March 19, 2004.

This Data Evaluation Record may have been altered by the Environmental Fate and Effects Division subsequent to
signing by CDM/CSS-Dynamac JV personnel. The CDM/CSS-Dynamac Joint Venture role does not include
establishing Agency policies.

EXECUTIVE SUMMARY:

In a 96-hour acute toxicity study, rainbow trout (Oncorhynchus mykiss) were exposed to DACTHAL W-75 (ai: Dacthal, 74.6%) at nominal concentrations of 0 (negative control), 4.66, 9.33, 18.7, 37.3, and 74.6 mg a.i./L (corresponding to formulation concentrations of 6.25, 12.5, 25, 50, and 100 mg form/L) under static conditions. The test item was unstable under the test conditions (the coefficient of variation ranged from 74 to 93% in analyzed samples, with recoveries ranging from 13 to 43% of initial measured concentrations). Poor solubility was evident as the test solutions were described as hazy to opaque white, non-homogenous liquid dispersions, with particulate material on the base of the test vessels that increased with increasing test concentration. Overall, the test material was both unstable and insoluble in all treatment levels. Therefore, the reviewer-calculated time weighted average (TWA)-measured test concentrations of <0.003 (<LOD, negative control), 1.44, 2.63. 8.64, 11.9, and 23.8 mg a.i./L were used for analysis and reporting.

After 96 hours of exposure, no mortality was observed in the control or any treatment group. Sublethal effects were observed in the three highest test levels starting 48 hours after exposure. Sublethal behavioral effects considered mild (e.g., increased cough frequency or a swimming position different than the control) ranged from 10 to 79% in the three highest test levels at test termination and were generally dose responsive. Sustained severe sublethal behavioral effects were not observed. The 96-hour LC50 was determined to be >23.8 mg a.i./L, and an observed NOAEC, based on mild toxic sublethal effects (cough frequency, differing swimming position relative to controls) was 2.63 mg a.i./L, based on the TWA-measured test concentrations.

All test vessels were not identical, which is a test validity requirement per OCSPP 850.1075. At test initiation, 14 fish instead of 7 fish were mistakenly added to one replicate of the TWA-measured 11.9 mg a.i./L test group. Due to the nature of the test substance forming a hazy dispersion, this error was not detected until the end of the test. While this replicate was excluded from the study author's analysis, the reviewer included this replicate as loading rate had no impact on mortality.

Based on the results of this study, the active ingredient (Dacthal) of the formulation Dacthal W-75, would be classified as practically non-toxic to Oncorhynchus mykiss up to the highest TWA-measured concentration tested in accordance with the classification system of the U.S. EPA.

This study is scientifically sound and is classified as supplemental and may be used for risk characterization.

   Results Synopsis

   Test Organism Size/Age (mean weight and/or length): 1.8626 g and 5.4 cm
   Test Type (Flow-through, Static, Static Renewal): Static

   LC50: >23.8 mg a.i./L		95% C.I.: N/A
   Probit Slope:	N/A			95% C.I.: N/A
	Observational NOAEC:  2.63 mg a.i./L

   Endpoint(s) Affected: Sublethal effects

I. MATERIALS AND METHODS

   GUIDELINE FOLLOWED:		The study was conducted according to OECD Guideline for Testing of Chemicals No. 203: Fish, Acute Toxicity Test (1992) and the US EPA Office of Prevention, Pesticides and Toxic Substances (OPPTS) draft guideline OPPTS 850.1075 (1996). The reviewer assessed the study using OCSPP 850.1075 (2016) and OECD 203 (2019), noting any similarities and/or differences where they existed, as well as OCSPP 850.1000 (2016). The following deficiencies and deviations were noted.

 The test 	material was both unstable and insoluble in all treatment levels. The reviewer-calculated coefficient of variation (CV) resulting from analytical test item confirmation ranged from 74 to 93%. Further, the 96-hour % of initial-measured concentrations ranged from 13 to 43%, which is well below the 80% threshold established by OCSPP 850.1000 and OECD 203. The test solutions were hazy to opaque white, non-homogenous liquid dispersions, with particulate material on the base of the test vessels. OCSPP 850.1000 recommends prior solubility trial testing if a test material has solubility issues as well as experimental design modifications. Although multiple experimental design modifications were available to the study author (e.g., saturator columns, environmental conditions, or solvent vehicles), none were utilized to improve solubility. Further, flow-through conditions may have improved stability.
 It was not reported if test treatments and organisms were randomly assigned to test vessels, which is a validity requirement of OCSPP 850.1075.
 All test vessels were not identical, which is another test validity requirement per OCSPP 850.1075. At test initiation, 14 fish were mistakenly added to one replicate of the 11.9 mg a.i./L test group. All other replicates only contained 7 fish. Due to the nature of the test substance forming a hazy dispersion, this error was not detected until the end of the test.
 The fish-loading rate for the 11.9 mg a.i./L test vessel containing 14 fish was calculated to be 1.04 g/fish/L. This value exceeds the OCSPP and OECD-recommended maximum fish-loading rate of 0.8 g/L.  Consequently, the biology results for this test vessel were excluded from the study author's toxicity calculations; however, the reviewer included this replicate as loading rate had no impact on mortality.
 During the test, the temperature ranged from 13.7 to 15.2 ℃ in the test solutions. OCSPP recommends a temperature of 12°C (+-2°C) for rainbow trout while OECD guidance recommends a range of 10 to 14°C.
 Each test vessel was aerated using an oil-free source of compressed air. According to OCSPP guidance, aeration of the test solutions during the test is not recommended. Gentle aeration of test vessels during the exposure period is permitted if the dissolved oxygen levels are in danger of dropping below 60% saturation. Dissolved oxygen concentrations in this study ranged from 83 to 110% saturation. According to OECD guidance, aeration can be used provided that it does not lead to a significant loss of test chemical.
 No lighting transition period was reported. OCSPP guidance recommends that a 15- to 30-minute transition period between light and dark is used.
 The light intensity during testing was not reported.
 The age of the fish at test initiation was not reported.
 Incomplete reporting of the physicochemical properties.
 Incomplete reporting of dilution water quality parameters.
 Per OCSPP 850.1075 and 1000, dechlorinated tap water is not recommended for preparation of dilution water and should only be used as a last resort because some forms of chlorine are difficult to remove adequately. OECD guidance allows for the use of dechlorinated water, although good quality natural water or reconstituted water is preferred. However, if dechlorinated tap water is used, it should be demonstrated that test organism survival, growth, and reproduction are not affected and that test organisms do not show other signs of stress. Additionally, chlorine analysis should be performed on each batch of dilution water. The residual chlorine concentrations were 0.01-0.05 mg/mL in the dilution water during the acclimation period, and 0.00  -  0.03 mg/mL in the dilution water control during the test. Draft OPPTS 850.1075 guidance recommends residual chlorine concentrations no higher than 0.003 mg/L in dilution water. The final OCSPP 1000 guideline recommends residual chlorine concentrations no higher than 0.01 mg/L in dilution water. This is considered a minor study deficiency.
 The statement of No Data Confidentiality Claims was missing a dated signature.

			These deficiencies and deviations do impact the acceptability of the study.

    COMPLIANCE:			Signed and dated Quality Assurance and GLP Standards statements were provided. An unsigned No Data Confidentiality Claims statement was included. The study was conducted in compliance with the United Kingdom Statutory Instrument 1999 No. 3106, The Good Laboratory Practice Regulations 1999, the OECD Principles on Good Laboratory Practice (revised 1997, Issued January 1998) ENV/MC/CHEM (98) 17. The following exception was noted: An expiry date for the test substance was not supplied by the Sponsor.

   A. MATERIALS:

   	1. Test material  				DACTHAL W-75 (ai: Dacthal)

      Description: 				Off-white powder

      Lot No./Batch No. :			2227

      Purity: 						74.6%

      Stability of compound
      under test conditions:		Unstable under testing conditions. The 96-hour % of initial measured concentrations ranged from 13 to 43% and the coefficient of variation based on analyzed samples ranged from 74 to 93%. Further, the test item was insoluble with observations of solutions as hazy to opaque white, non-homogenous liquid dispersions, with particulate material on the base of the test vessels increasing in amount with concentration.
(OECD recommends stability in water and light)

      Storage conditions of
      test chemicals: 				All precautions required in the handling, storage, and disposal of the test substance normally taken for a new chemical undergoing safety evaluation was outlined by the Sponsor. Further details were not provided.

		Physicochemical properties of DACTHAL W-75 (ai: Dacthal).
Parameter
Values
Comments
Water solubility at 20°C
Not reported

Vapor pressure
Not reported

UV absorption
Not reported

pKa
Not reported

Kow
Not reported

   	2. Test organism:

      Species: 					Rainbow trout, Oncorhynchus mykiss
      							EPA recommends a cold water species (preferably rainbow trout, Oncorhynchus mykiss) and a warm water species (preferably bluegill sunfish, Lepomis macrochirus or fathead minnow, Pimephales promelas). If a marine/estuarine species is desired, sheepshead minnow, Cyprinodon variegatus, is recommended. OECD recommends choice of species at discretion of testing laboratory.
      Age at test initiation:			Not reported
                           EPA recommends juvenile fish.
      Weight at study initiation: 	1.8626 g (range 1.5628 to 2.2541 g)
                     EPA recommends: <3.0 g.
      Length at study initiation: 	5.4 cm (range 4.9 to 5.8 cm)
EPA recommends: Longest not >2x shortest; OECD recommends 2.0 +- 1.0 cm for bluegill and 5.0 +- 1.0 cm for rainbow trout.
      Source:  					Brow Well Fisheries Ltd., Phoenix, Cottage, Hebden, Skipton, North Yorkshire, BD23 5DH
      							EPA recommends that all organisms be from the same source.

   B.  STUDY DESIGN:

      1. Experimental Conditions

      a. Range-finding study  -  The nominal concentrations used in the 96-hour range-finding test were 0 (control), 0.1, 1.0, 10 and 100 mg form/L (corresponding to 0.0746, 0.746, 7.46 and 74.6 mg ai/L, based on the 74.6 % Dacthal active ingredient content of DACTHAL W-75). Each test concentration contained one replicate with 5 exposed fish. At 96 hours, two out of five fish exposed at 10 mg form/L exhibited mild toxic effects. At the 100 mg form/L exposure concentration, 3 out of 5 fish exhibited mild toxic effects and the remaining 2 fish exhibited severe toxic effects. Two fish in the 1.0 mg form/L treatment group jumped out of the aquarium at 72 hours and were found dead beside the vessel. No treatment-related mortalities were observed in this study. Based on these results, the concentrations selected for the definitive test were 6.25, 12.5, 25, 50 and 100 mg form/L.

      EPA recommends that definitive testing may be waived if limit testing with at least 30 organisms shows LC50 levels to be greater than 1,000 mg/L based on 100 percent active ingredients (AI), or the limits of water solubility or dispersibility. For pesticides, a lower level of 100 mg AI/L may be tested when estimated environmental concentrations are not expected to exceed 100 mg/L (ppm).

      b. Definitive Study

Table 1:  Experimental Parameters
                                   Parameter
                                    Details
                                    Remarks

                                   Criteria
Acclimation
Period:

Conditions: (same as test or not)

Feeding:

Health: (any mortality observed)

>=12 days (after a 48-hour settling period)

Similar to test conditions (16L:8D photoperiod; pH of 7.0 to 7.4, dissolved oxygen of 78-87%, temperature of 13.2 to 14.7℃).

Proprietary food (Nutrafry AB 02 (TROUW UK)). Fish were not fed in the 48-hours preceding the definitive test.

No mortality during the 7-day period preceding the test. The stock of fish would not be used for testing if mortality exceeded 5% or if disease was apparent.

The recommended acclimation period is 14 days (at a minimum 12 days), and a minimum of 7 days acclimation in test dilution water at test temperature. OECD guideline recommends a minimum of 12 days. Wild caught fish should be quarantined 7 days before acclimation begins.

Acclimation temperature change should be <3°C per day.
No feeding or disease treatments permitted within 48 hrs of test initiation or during test.

Pretest mortality must be <5% 48 hrs prior to testing. If >10%, batch must be rejected.  OECD pretest mortality criteria: >10%= rejection of entire batch; 5-10%= continued acclimation for 7 days; <5%= acceptable.
Duration of the test
96 hours

The recommended test duration is a minimum 96 hours.
Test condition

Static/static renewal/flow-through

Type of dilution system - for flow- through method

Renewal rate for static renewal

Static

N/A

N/A

Static renewal or flow-through is necessary when test concentrations are expected to decline during the study period to <70% of the day-0 measured concentrations.  A reproducible supply of toxicant is recommended.  Consistent flow rate should be 6-10 vol/24 hours for flow-through systems; diluter systems should be monitored for proper calibration before and every 24 hours during study. Flow rate to each replicate should be measured at the beginning and end of each test, and not vary by more than a factor of 10 between replicates.
Aeration, if any
Each test vessel was aerated using an oil-free source of compressed air.

Aeration is not recommended for flow-through tests, but gentle aeration is permitted in static systems only to keep oxygen levels at 60%. OECD guideline recommends aeration.  If aeration is necessary, test solutions must be analyzed periodically to verify exposure.
Test vessel
Material: (glass/stainless steel)

Size:

Fill volume:

Glass aquariums

30 L

25 L

Loading
Static or static-renewal tests: <=0.8 g wet weight per liter;
Flow-through test: <=0.5 g/L per 24 hours and <5 g/L at any time
Source of dilution water

Quality of dilution water
Particulate matter:
COD:
TOC:
Boron and fluoride:
Residual chlorine:
Un-ionized ammonia:
Aluminum, arsenic, chromium, cobalt, copper, iron, lead, nickel and zinc:

Cadmium, mercury and silver:

Total organophosphorus pesticides:
Total organochlorine pesticides +
    PCBs or organic chlorine:

Specific conductivity:
Hardness as CaCO3:
Dechlorinated municipal mains water*

Not reported
Not reported
Not reported
Not reported
<=0.05 mg/mL
Not reported

Copper: 65 ug/L; Zinc: 73 ug/L; Aluminum, Iron, Lead: <reporting limit; Values for other metals not reported
Cadmium: <reporting limit; Values for other metals not reported
Not reported

<Reporting limit

187 uS/cm
27 mg/L Ca
* Pumped to the laboratory via a
Purite AC9 activated carbon filter and a Purite ROPF 20 particulate filter, then chilled to approximately 14 °C.

Recommended source of dilution water is clean surface or ground water, seawater (for estuarine or marine species), and reconstituted water. EPA does not recommend the use of dechlorinated tap water; however, if used, daily chlorine analysis is recommended.  Maximum allowable concentrations for water quality parameters are provided in EPA's 850.1075 guideline (http://www.epa.gov/ocspp/pubs/frs/home/draftguidelines.htm).  OECD permits dechlorinated tap water.
Water quality during testing
Hardness:

pH:

Dissolved oxygen:

Temperature:

Other measurements
Photoperiod:

Light intensity:

Intervals of water quality measurement

74 to 80 mg/L as CaCO3

7.3 to 7.6

83 to 110% saturation

13.7 to 15.2 ℃

16-hr L:8-hr D

Not reported

Dissolved oxygen, temperature, and pH were measured daily in each test item vessel. The temperature range (min and max) of the control test media was determined every 24 hours.

Total hardness was determined at the start and end of the test in the control test solution.

Residual chlorine was measured every 24 hours in one of the control test vessels.
Residual chlorine: 0.00 to 0.03 mg/L

EPA Recommendations:
Hardness: 40-180 mg/L as CaCO3 (OECD recommends 10 - 250 mg/L)
pH:  > 6.0 and < 8.0 for freshwater testing, and > 7.5 and < 8.5 for marine testing. (OECD recommends  pH 6.0 - 8.5)
Dissolved Oxygen: Static: > 60% saturation;  flow-through: > 75% saturation; (OECD recommends at least 80% saturation value).
Temperature:10-12 +-2 °C for coldwater species and 22-23+-2 °C for warmwater species, (OECD recommends 21-25°C for bluegill and 13-17[o]C for rainbow trout). Temperature should not vary >1°C in any 24-hour period.
Salinity:  20+-5 %. for estuarine species.

Photoperiod: 12 hours light and 12 hours dark, to 16 hours light and 8 hours dark, with a 15 to 30 minute transition period. (OECD recommends a photoperiod of 12-16 hours light).
Light intensity should range from 30-100 lumens at the water surface;

DO, pH and temperature should be measured in each replicate at test initiation and every 24 hours. Temperature should also be measured in one replicate at least hourly. Water hardness or salinity, as appropriate, should be measured at test initiation; in marine flow-through tests, salinity should be recorded at test initiation, on day 4, and if extended, on days 7 and 14.
Number of replicates/groups:
Negative control:
Solvent control:
Treatments:

2
N/A
2/level

Recommended number of replicates is 2 per test concentration and control.
Number of organisms per replicate /groups:
Negative control:
Solvent control:
Treatments:

7
N/A
7/level*
*At test initiation 14 fish instead of 7 fish were added to one replicate of the TWA-measured 11.9 mg ai/L test group. Due to the nature of the test substance forming a hazy dispersion, this error was not detected until the end of the test.

Number of organisms per replicate per test concentration and control/solvent control should be a minimum 7, >= 10 is recommended; OECD guideline recommends at least 7 fish/concentration.
Biomass loading rate
0.51 g fish/L/day*

* The fish-loading rate of the TWA-measured 11.9 mg ai/L test group was calculated to be 1.04 g/fish/L. This value exceeds the required maximum fish-loading rate for the test (0.8 g/L). Consequently, the biology results for this test vessel were excluded from the study author's toxicity calculations.

Recommended static conditions are <= 0.8 g FWF/L per replicate and for flow-through are <= 0.5 g FWF/L per replicate within 24 hours. OECD recommends a maximum of 1 g fish/L for static and semi-static, while higher rates are recommended for flow-through.
Test concentrations:

Nominal (formulation):

Nominal (active ingredient):

TWA-measured:

0 (negative control), 6.25, 12.5, 25. 50, and 100 mg form/L

0 (negative control), 4.66, 9.33, 18.7, 37.3, and 74.6 mg a.i./L

<0.003 mg a.i./L (<LOD, control), 1.44, 2.63, 8.64, 11.9, and 23.8 mg a.i./L*

*Calculated by the reviewer (refer to copy of Excel worksheet in Appendix I).
EPA recommends a minimum of 5 test concentrations, in geometric series with a ratio of 1.5 to 2.2, plus a control/solvent control. Test concentrations should be selected to produce a no-observable-effect concentration (NOEC) and, preferably, at least two partial mortalities, i.e. one greater than and the other less than 50% after 96 hours.

Test concentration must be measured at test initiation and every 48 hours in each replicate until 96 hours, and after every malfunction in the appropriate chamber, and for static tests after every renewal. After 96 hours, test concentration measurements are recommended only every 96 hours.

No more than 25 percent variation is allowed between test concentrations within the same treatment during the test.
Solvent (type, percentage, if used)
N/A

The solvent should not exceed 0.5 ml/L for static tests or 0.1 ml/L for flow-through tests; OECD recommends that the solvent not exceed 100 mg/L. Preferred solvents are dimethyl formamide, triethylene glycol, methanol, acetone, or ethanol.
Feeding
The fish were not fed in the 48-hour period preceding the test or during testing.

Fish should not feed during the study.

Recovery of chemical
Frequency of determination
Level of quantization
Level of detection

0, 48, and 96 hours
Not reported
0.003 mg a.i./L (0.004 mg form/L)

Positive control:
Nominal concentrations:
N/A

Other parameters, if any
None

   2. Observations:

Table 2:  Observations
                                   Parameter
                                    Details
                                    Remarks

                                   Criteria
Parameters measured including the sublethal effects/toxicity symptoms
Mortality and behavioral abnormalities (sublethal effects)

Recommended parameters measured include:
- mortality;
- immobility;
- incidence and description of morphological
     abnormalities and behavioral effects;
- observations of other effects or clinical signs.
Observation intervals
Observations were made at 17.42, 24, 48, 72, and 96 hours.

Mortality observations should be recorded at 6, 24, 48, 72 and 96 hours, and if continued, every 24 hours until test termination.
Were raw data included?
Yes.

Other observations, if any
Stock solutions appeared as white hazy emulsions with foaming on the surface at the two highest concentrations.

The test media generally appeared as hazy to opaque white, non-homogenous liquid dispersions, with particulate material on the base of the test vessels increasing in amount with concentration. At 24, 48, and 72 hours, foaming was present on the surface of the test media at the highest test concentration.

II. RESULTS AND DISCUSSION:

   A. MORTALITY:

   By 96 hours, there was a complete absence of mortality in the control and all treatment groups.

   EPA/OECD recommend pretreatment control mortality <10%. EPA recommends control or solvent control mortality be <10 % (or 1 mortality if 7 to 10 control fish are used) for a 96 - h period of testing. If the test is continued past 96 h, the maximum-allowable additional mortality is 10%.  OECD also recommends that maximum-allowable control or solvent control mortality is 10% (or 1 mortality if 7 to 10 control fish are used) for a 96-h period of testing.

Table 3:  Effect of DACTHAL W-75 (ai: Dacthal) on Mortality of Oncorhynchus mykiss[1].
                                 TWA-Measured
                   (and Nominal) Concentrations,
mg a.i./L
                         No. of fish at start of study
                              Observation period

                                   24 Hours
                                   72 Hours
                                   96 Hours

                                   No. Dead
                                  % Mortality
                                   No. Dead
                                  % Mortality
                                   No. Dead
                                  % Mortality
Control (<LOD)
                                      14
                                       0
                                       0
                                       0
                                       0
                                       0
                                       0
1.44 (4.66)
                                      14
                                       0
                                       0
                                       0
                                       0
                                       0
                                       0
2.63 (9.33)
                                      14
                                       0
                                       0
                                       0
                                       0
                                       0
                                       0
8.64 (18.7)
                                      14
                                       0
                                       0
                                       0
                                       0
                                       0
                                       0
11.9 (37.3)
                                      21*
                                       0
                                       0
                                       0
                                       0
                                       0
                                       0
23.8 (74.6)
                                      14
                                       0
                                       0
                                       0
                                       0
                                       0
                                       0
LC50
>100 mg form/L (based on study author's results)
Positive control, if used
mortality:
LC50:

N/A
     [1] Data obtained from Table 3, p. 23 of the study report.
    * At test initiation 14 fish, instead of 7, were added to one replicate of the 11.9 mg a.i./L test group. Due to the nature of the test substance forming a hazy dispersion, this error was not detected until the end of the test.
  LOD = 0.003 mg/L

   B. SUB-LETHAL TOXICITY ENDPOINTS:

   All fish appeared normal after 24 hours of exposure. Mild toxic effects, such as increased cough frequency or a swimming position different than the control, were observed in the three highest test concentrations from 48 hours through the end of the test. The number of fish exhibiting mild effects generally increased with increasing test concentration. Severe toxic effects (e.g., swimming abnormally or lying on bottom of tank) were only observed in one fish in the highest test concentration after 72 hours of exposure.

Table 4:  Sub-lethal Effect of DACTHAL W-75 (ai: Dacthal) on Oncorhynchus mykiss[1].
                                 TWA-Measured
                   (and Nominal) Concentrations,
mg a.i./L
                              Observation period

                                   24 Hours
                                   48 Hours
                                   72 Hours
                                   96 hours

                              % with mild effects
                          % with severe toxic effects
                              % with mild effects
                          % with severe toxic effects
                              % with mild effects
                          % with severe toxic effects
                              % with mild effects
                          % with severe toxic effects
Control (<LOD)
                                       0
                                       0
                                       0
                                       0
                                       0
                                       0
                                       0
                                       0
1.44 (4.66)
                                       0
                                       0
                                       0
                                       0
                                       0
                                       0
                                       0
                                       0
2.63 (9.33)
                                       0
                                       0
                                       0
                                       0
                                       0
                                       0
                                       0
                                       0
8.64 (18.7)
                                       0
                                       0
                                       7
                                       0
                                      21
                                       0
                                      21
                                       0
11.9 (37.3)*
                                       0
                                       0
                                      36
                                       0
                                      29
                                       0
                                      10
                                       0
23.8 (74.6)
                                       0
                                       0
                                      86
                                       0
                                      93
                                       7
                                      79
                                       0
[1] The % effects were calculated by the reviewer in Excel using the data provided in Table 3, p. 23 of the study report. Mild toxic effects: swimming normally but exhibiting mild effects e.g., increased cough frequency, swimming position in test vessel different to controls. Severe toxic effects: e.g., swimming abnormally or lying on bottom of tank.
*At test initiation 14 fish, instead of 7, were mistakenly added to one replicate of the 11.9 mg a.i./L test group. Due to the nature of the test substance forming a hazy dispersion, this error was not detected until the end of the test. The % with sublethal effects is based on 21 fish in this treatment group for the 96-hour results only.
LOD = 0.003 mg/L

   C. REPORTED STATISTICS:

   No significant mortality was recorded during the definitive test. Therefore, the 96-hour LC50 value could not be calculated and was visually estimated to be greater than the highest test concentration. The NOAEC was established by observation of the mortality and sublethal effect raw data. The study author's results were based nominal concentrations of the formulation.

   LC50: >100 mg form/L		95% C.I.:  N/A
   Probit Slope:	N/A				95% C.I.: N/A
   Observational NOAEC:  12.5 mg form/L

   Endpoint(s) Affected: Sublethal effects

   D. VERIFICATION OF STATISTICAL RESULTS:

   The mortality data were analyzed using CETIS Version <IP_ADDRESS> with database backend settings implemented by EFED on 7/25/17. Since no mortality was observed in any of the treatment levels, the LC50 was empirically determined to be greater than the highest TWA-measured test concentration. A No Comparisons report was generated.

   LC50: >23.8 mg a.i./L		95% C.I.: N/A
   Probit Slope:	N/A			95% C.I.: N/A
	Observational NOAEC:  2.63 mg a.i./L

   Endpoint(s) Affected: Sublethal effects

   E.  STUDY DEFICIENCIES:

 The test 	material was unstable and insoluble in all treatment levels. The reviewer-calculated coefficient of variation (CV) resulting from analytical test item confirmation ranged from 74 to 93% (refer to copy of Excel worksheet in Appendix I). Further, the 96-hour % of initial-measured concentrations ranged from 13 to 43%, which is well below the 80% threshold established by OCSPP 850.1000 and OECD 203. The test solutions were hazy to opaque white, non-homogenous liquid dispersions, with particulate material on the base of the test vessels. OCSPP 850.1000 recommends prior solubility trial testing if a test material has solubility issues as well as experimental design modifications. Although multiple experimental design modifications were available to the study author (e.g., saturator columns, environmental conditions, or solvent vehicles), none were utilized to improve solubility. Further, flow-through conditions may have improved stability.
 It was not reported if test treatments and organisms were randomly assigned to test vessels, which is a validity requirement of OCSPP 850.1075.
 At test initiation, 14 fish were mistakenly added to one replicate of the 11.9 mg a.i./L test group. All other replicates only contained 7 fish. Due to the nature of the test substance forming a hazy dispersion, this error was not detected until the end of the test. It is a test validity requirement for OCSPP 850.1075 that all test vessels are identical.
 Per OCSPP 850.1075 and 1000, dechlorinated tap water is not recommended for preparation of dilution water and should only be used as a last resort because some forms of chlorine are difficult to remove adequately. OECD guidance allows for the use of dechlorinated water, although good quality natural water or reconstituted water is preferred. However, if dechlorinated tap water is used, it should be demonstrated that test organism survival, growth, and reproduction are not affected and that test organisms do not show other signs of stress. Additionally, chlorine analysis should be performed on each batch of dilution water. The residual chlorine concentrations were 0.01-0.05 mg/mL in the dilution water during the acclimation period, and 0.00  -  0.03 mg/mL in the dilution water control during the test. Draft OPPTS 850.1075 guidance recommends residual chlorine concentrations no higher than 0.003 mg/L in dilution water. Draft OPPTS 850.1075 guidance recommends residual chlorine concentrations no higher than 0.003 mg/L in dilution water. The final OCSPP 1000 guideline recommends residual chlorine concentrations no higher than 0.01 mg/L in dilution water. Given the adequate control performance, this is considered a minor study deficiency.

   F.  REVIEWER'S COMMENTS:

   The study author's and the reviewer's LC50 values were in agreement after taking into consideration the difference in concentrations used for analysis. The study author's results were based on the nominal formulation concentrations, whereas the reviewer's results were based on the TWA-measured test concentrations (refer to copy of Excel worksheet in Appendix I). The reviewer's results are presented in the Executive Summary and Conclusions sections of this DER because the test material was unstable and TWA-measured concentrations are preferred when the coefficient of variation of the analytical data is >=20%.

   At test initiation, 14 fish instead of 7 fish were mistakenly added to one replicate of the TWA-measured 11.9 mg a.i./L test group. Due to the nature of the test substance forming a hazy dispersion, this error was not detected until the end of the test. The fish-loading rate for this test vessel was calculated to be 1.04 g/fish/L. This value exceeds the OCSPP and OECD-recommended maximum fish-loading rate for the test (0.8 g/L). While this replicate was excluded from the study author's analysis, the reviewer included this replicate as loading rate had no impact on mortality.

	The following OCSPP 850.1075 (2016) validity criteria were NOT met:
 All test vessels were not identical. (In this study, one replicate in the 11.9 mg a.i./L treatment group contained 14 fish. All other replicates contained 7 fish.)
 Treatments were not reported to be randomly or indiscriminately assigned to individual test vessel locations, or individual test organisms were not reported to be randomly or indiscriminately assigned to test vessels. (It was not reported if treatments or organisms were randomly assigned in this study.)

   All OECD 203 (2019) validity criteria were met.

   The study was conducted following the draft OPPTS 850.1075 (1996) guideline, OECD 203 guideline (1992), and the reviewer considered both the draft and the final OCSPP 850.1075 (2016) guideline and updated OECD 203 guideline (2019) and OCSPP 850.1000 guideline in their evaluation of the data.

   The in-life phase of the study was conducted sometime between October 7 and November 16, 2003.

   G. CONCLUSIONS:

   This study is scientifically sound and is classified as supplemental and may be used for risk characterization.  No mortality was observed in the control or any treatment groups throughout the 96-hour exposure. Sublethal effects (mild effects, e.g., increased cough frequency, swimming position in test vessel different to controls) were observed in the >=8.64 mg a.i./L treatment groups starting at 48 hours. Effects were generally dose responsive. The 96-hour LC50 is >23.8 mg a.i./L, and an observed NOAEC based on mild sublethal behavioral effects (cough frequency, differing swimming position relative to controls) was 2.63 mg a.i./L, based on the TWA-measured test concentrations.

III.  REFERENCES:

Stephan, C.E., K.A. Busch, R. Smith, J. Burk and R.W. Andrews. 1978. A computer program for calculating an LC50. U.S. Environmental Protection Agency, Duluth, Minnesota, pre-publication manuscript, August, 1978.

All other references listed referred to standard guidelines.
APPENDIX I. Copy of Excel Worksheet with TWA Concentrations


[Federal Register Volume 78, Number 131 (Tuesday, July 9, 2013)]
[Notices]
[Pages 41055-41056]
[FR Doc No: 2013-16446]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
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effective 7/1/2013.
    Filed Date: 6/28/13.
    Accession Number: 20130628-5276.
    Comments Due: 5 p.m. ET 7/19/13.

    Take notice that the Commission received the following qualifying
facility filings:

    Docket Numbers: QF13-532-000.
    Applicants: Verizon Corporate Services Group Inc.
    Description: Form 556 of Verizon Corporate Services Group Inc.
    Filed Date: 6/27/13.
    Accession Number: 20130627-5059.
    Comments Due: None Applicable.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 1, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-16446 Filed 7-8-13; 8:45 am]
BILLING CODE 6717-01-P