[Federal Register Volume 77, Number 28 (Friday, February 10, 2012)]
[Rules and Regulations]
[Page 6963]
[FR Doc No: 2012-3101]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2012-0006]

Drawbridge Operation Regulations; Merrimack River, Amesbury, MA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
1st Lt. Derek S. Hines Memorial Bridge, mile 5.8, across the Merrimack
River at Amesbury (Newburyport), Massachusetts. The deviation is
necessary to facilitate bridge rehabilitation and repairs. This
deviation allows the bridge to remain in the closed position for four
months.

DATES: This deviation is effective from February 13, 2012 through May
11, 2012.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2012-0006 and are available online
at www.regulations.gov, inserting USCG-2012-0006 in the ``Keyword'' and
then clicking ``Search''. They are also available for inspection or
copying at the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Joe Arca, Project Officer, First Coast Guard
District<EMAIL_ADDRESS>or telephone<PHONE_NUMBER>. If you have
questions on viewing the docket, call Renee V. Wright, Program Manager,
Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The 1st Lt. Derek S. Hines Memorial Bridge,
across the Merrimack River, mile 5.8, at Amesbury (Newburyport),
Massachusetts, has a vertical clearance in the closed position of 13
feet at mean high water and 20 feet at mean low water. The drawbridge
operation regulations are listed at 33 CFR 117.605(c).
    The owner of the bridge, Massachusetts Department of
Transportation, requested a temporary deviation from the regulations to
facilitate bridge rehabilitation repairs, replacement of operating
machinery, structural steel, and highway deck on the swing span.
    Under this temporary deviation the bridge may remain in the closed
position from February 13, 2012 through May 11, 2012.
    The bridge rarely opens during the time period this temporary
deviation will be in effect. In addition, mariners may use an alternate
channel to the south under the Chain Bridge, which is a fixed highway
bridge that provides 28 feet of vertical clearance at mean high water
and 35 feet of vertical clearance at mean low water.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: February 1, 2012.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2012-3101 Filed 2-9-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 45 (Tuesday, March 8, 2022)]
[Notices]
[Pages 12950-12952]
[FR Doc No: 2022-04871]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP21-94-000]

Transcontinental Gas Pipe Line Company, LLC; Notice of
Availability of the Draft Environmental Impact Statement for the
Proposed Regional Energy Access Expansion

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared a draft environmental impact statement (EIS)
for the Regional Energy Access Expansion (Project), proposed by
Transcontinental Gas Pipe Line Company, LLC (Transco) in the above-
referenced docket. Transco requests authorization to construct and
operate approximately 36.1 miles of pipeline loop \1\ and one new
compressor station, abandon and replace certain existing compression
facilities, and modify existing compressor stations and facilities in
Pennsylvania and New Jersey to provide about 829 million standard cubic
feet of natural gas per day to multiple delivery points along Transco's
existing system in Pennsylvania, New Jersey, and Maryland, providing
customers with enhanced access to Marcellus and Utica Shale natural gas
supplies.
---------------------------------------------------------------------------

    \1\ A pipeline loop is a segment of pipe constructed parallel to
an existing pipeline to increase capacity.
---------------------------------------------------------------------------

    The draft EIS assesses the potential environmental effects of the
construction and operation of the Project in accordance with the
requirements of the National Environmental Policy Act (NEPA). The FERC
staff concludes that approval of the proposed Project, with the
mitigation measures recommended in the EIS, would result in some
adverse environmental impacts; however, with the exception of climate
change impacts, those impacts would not be significant. The Project's
annual operation and downstream emissions of 16.62 million metric tons
of carbon dioxide equivalent would exceed the Commission's presumptive
significance threshold based on 100 percent utilization.
    The U.S. Environmental Protection Agency and U.S. Army Corps of
Engineers participated as cooperating agencies in the preparation of
the EIS. Cooperating agencies have jurisdiction by law or special
expertise with respect to resources potentially affected by the
proposal and participate in the NEPA analysis. The EIS is intended to
fulfill the cooperating federal agencies' NEPA obligations, as
applicable, and to support subsequent conclusions and decisions made by
the cooperating agencies. Although cooperating agencies provide input
to the conclusions and recommendations presented in the draft EIS, the
agencies may present their own conclusions and recommendations in any
applicable Records of Decision for the Project.
    The draft EIS addresses the potential environmental effects of the
construction and operation of the following Project facilities:
     Installation of 22.3 miles of 30-inch-diameter pipeline
loop in Luzerne County, Pennsylvania (Regional Energy Lateral);
     installation of 13.8 miles of 42-inch-diameter pipeline
loop in Monroe County, Pennsylvania (Effort Loop);
     installation of the new Compressor Station 201 (9,000
nominal horsepower [hp] at International Organization of
Standardization [ISO] conditions) in Gloucester County, New Jersey);
     installation of two gas turbine driven compressor units
(31,800 nominal hp at ISO conditions) at existing Compressor Station
505 in Somerset County, New Jersey to accommodate the abandonment and
replacement of approximately 16,000 hp from eight existing internal
combustion engine-driven compressor units and increase the certificated
station compression by 15,800 hp;
     installation of a gas turbine compressor unit (63,742
nominal hp at ISO conditions) and modifications to three existing
compressors at existing Compressor Station 515 in Luzerne County,
Pennsylvania to accommodate the abandonment and replacement of
approximately 17,000 hp from five existing gas-fired reciprocating
engine driven compressors and increase the certificated station
compression by 46,742 hp;
     uprate and rewheel two existing electric motor-driven
compressor units at existing Compressor Station 195 in York County,
Pennsylvania to increase the certificated station compression by 5,000
hp and accommodate the abandonment of two existing gas-fired
reciprocating engine driven compressors, which total approximately
8,000 hp;
     modifications at existing compressor stations, meter
stations, interconnects, and ancillary facilities in Pennsylvania, New
Jersey, and Maryland; and
     installation of ancillary facilities such as mainline
valves,

communication facilities, and pig launchers \2\ and receivers.
---------------------------------------------------------------------------

    \2\ A ``pig'' is a tool that the pipeline company inserts into
and pushes through the pipeline for cleaning the pipeline,
conducting internal inspections, or other purposes.
---------------------------------------------------------------------------

    The Commission mailed a copy of the Notice of Availability of the
draft EIS to federal, state, and local government representatives and
agencies; elected officials; environmental and public interest groups;
Native American tribes; potentially affected landowners and other
interested individuals and groups; and newspapers and libraries in the
Project area. The draft EIS is only available in electronic format. It
may be viewed and downloaded from the FERC's website (www.ferc.gov), on
the natural gas environmental documents page (https://www.ferc.gov/industries-data/natural-gas/environment/environmental-documents). In
addition, the draft EIS may be accessed by using the eLibrary link on
the FERC's website. Click on the eLibrary link (https://elibrary.ferc.gov/eLibrary/search) select ``General Search'' and enter
the docket number in the ``Docket Number'' field, excluding the last
three digits (i.e., CP21-94). Be sure you have selected an appropriate
date range. For assistance, please contact FERC Online Support at
[email protected] or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.
    The draft EIS is not a decision document. It presents Commission
staff's independent analysis of the environmental issues for the
Commission to consider when addressing the merits of all issues in this
proceeding. Any person wishing to comment on the draft EIS may do so.
Your comments should focus on the draft EIS' disclosure and discussion
of potential environmental effects, reasonable alternatives, and
measures to avoid or lessen environmental impacts. To ensure
consideration of your comments on the proposal in the final EIS, it is
important that the Commission receive your comments on or before 5:00
p.m. Eastern Time on April 25, 2022.
    For your convenience, there are four methods you can use to submit
your comments to the Commission. The Commission will provide equal
consideration to all comments received, whether filed in written form
or provided orally. The Commission encourages electronic filing of
comments and has staff available to assist you at<PHONE_NUMBER> or
[email protected]. Please carefully follow these instructions
so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature on the Commission's website (www.ferc.gov) under the link to
FERC Online. This is an easy method for submitting brief, text-only
comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature on the Commission's website (www.ferc.gov) under the link to
FERC Online. With eFiling, you can provide comments in a variety of
formats by attaching them as a file with your submission. New eFiling
users must first create an account by clicking on ``eRegister.'' If you
are filing a comment on a particular project, please select ``Comment
on a Filing'' as the filing type; or
    (3) You can file a paper copy of your comments by mailing them to
the Commission. Be sure to reference the project docket number (CP21-
94-000) on your letter. Submissions sent via the U.S. Postal Service
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC
20426. Submissions sent via any other carrier must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    (4) In lieu of sending written or electronic comments, the
Commission invites you to attend one of the virtual public comment
sessions its staff will conduct by telephone to receive comments on the
draft EIS, scheduled as follows:

------------------------------------------------------------------------
                              Date and time
-------------------------------------------------------------------------
 Monday, March 28, 2022, 6:00-8:00 p.m. (EST), Call in number: 800-779-
 8625, Participant Passcode: 3472916.
 Tuesday, March 29, 2022, 12:00-2:00 p.m. (EST), Call in number: 888-848-
 6716, Participant Passcode: 4258437.
 Wednesday, March 30, 2022, 6:00-8:00 p.m. (EST), Call in number: 800-
 779-8625, Participant Passcode: 3472916.
------------------------------------------------------------------------

    The primary goal of these comment sessions is to have you identify
the specific environmental issues and concerns with the draft EIS.
There will not be a formal presentation by Commission staff when the
session opens. Individual oral comments will be taken on a one-on-one
basis with a court reporter present on the line. This format is
designed to receive the maximum amount of oral comments, in a
convenient way during the timeframe allotted, and is in response to the
ongoing COVID-19 pandemic. Prospective commentors are encouraged to
review the draft EIS to familiarize themselves with the Project prior
to participating in the meeting.
    Each comment session is scheduled from either 6:00 to 8:00 p.m. or
else 12:00 p.m. (noon) to 2:00 p.m., Eastern Standard Time. You may
call at any time after the listed start times, at which point you will
be placed on mute and hold. Calls will be answered in the order they
are received. Once answered, you will have the opportunity to provide
your comment directly to a court reporter with FERC staff or
representative present on the line. A time limit of 3 minutes will be
implemented for each commentor.
    Transcripts of all comments received during the comment sessions
will be publicly available on FERC's eLibrary system (see page 2 of
this notice for instructions on using eLibrary).
    It is important to note that the Commission provides equal
consideration to all comments received, whether filed in written form
or provided at a virtual comment session.
    Any person seeking to become a party to the proceeding must file a
motion to intervene pursuant to Rule 214 of the Commission's Rules of
Practice and Procedures (18 CFR part 385.214). Motions to intervene are
more fully described at https://www.ferc.gov/how-intervene. Only
intervenors have the right to seek rehearing or judicial review of the
Commission's decision. The Commission grants affected landowners and
others with environmental concerns intervenor status upon showing good
cause by stating that they have a clear and direct interest in this
proceeding which no other party can adequately represent. Simply filing
environmental comments will not give you intervenor status, but you do
not need intervenor status to have your comments considered.

Questions?

    Additional information about the Project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website (www.ferc.gov) using the eLibrary link. The eLibrary link
also provides access to the texts of all formal documents issued by the
Commission, such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription that allows you to keep track of all formal issuances and
submittals in specific dockets. This can reduce the amount of time you
spend researching proceedings by automatically providing you with

notification of these filings, document summaries, and direct links to
the documents. Go to https://www.ferc.gov/ferc-online/overview to
register for eSubscription.

    Dated: March 2, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-04871 Filed 3-7-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 8, 2010 (Volume 75, Number 25)]
[Notices]
[Page 6248-6249]
[DOCID:fr08fe10-103]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61459; File No. SR-ISE-2010-07]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Foreign Currency Options

February 1, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on January 19, 2010, the International Securities Exchange, LLC
(the ``Exchange'' or the ``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

    The ISE is proposing to amend its incentive plan for market makers
in a newly listed foreign currency option and to establish fees for
transactions in the newly listed foreign currency option. The text of
the proposed rule change is available on the Exchange's Web site
(http://www.ise.com), on the Commission's Web site at http://
www.sec.gov, 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 self-regulatory organization
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 this proposed rule change is to amend the Exchange's
incentive plan for market makers on a newly listed foreign currency
option, specifically, the Brazilian real (``BRB'') \3\ and to establish
fees for transactions in options on BRB. Options on BRB began trading
on the Exchange on January 19, 2010. As such, this proposed fee change
will be operative and effective on January 19, 2010.
---------------------------------------------------------------------------

    \3\ The Commission previously approved the trading of options on
BRB. See Securities Exchange Act Release No. 55575 (April 3, 2007),
72 FR 17963 (April 10, 2007) (SR-ISE-2006-59).
---------------------------------------------------------------------------

    In order to promote trading in options on BRB, the Exchange
proposes to add BRB to the incentive plan the Exchange currently has in
place for market makers in options on the New Zealand dollar (``NZD''),
the Mexican peso (``PZO'') and the Swedish krona (``SKA'').\4\ Market
makers will be able to enter into the incentive plan until March 31,
2010.\5\ Participants in the incentive plan are known on the Exchange's
Schedule of Fees as Early Adopter Market Makers. Under the incentive
plan, the Exchange will waive the applicable transaction fees for both
the Early Adopter FXPMM \6\ and all Early Adopter FXCMMs \7\ that make
a market in BRB for as long as the incentive plan is in effect.
Further, pursuant to a revenue sharing agreement entered into between
an Early Adopter Market Maker and ISE, the Exchange will pay the Early
Adopter FXPMM forty percent (40%) of the transaction fees collected on
any customer trade in BRB and will pay up to ten (10) Early Adopter
FXCMMs that participate in the incentive plan twenty percent (20%) of
the transaction fees collected for trades between a customer and that
FXCMM. Market makers that do not participate in the incentive plan,
i.e., market makers that begin to quote and trade in BRB after March
31, 2010, will be charged regular transaction fees for trades in this
product.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 60536 (August 19,
2009), 74 FR 43204 (August 26, 2009) (SR-ISE-2009-59).
    \5\ See Securities Exchange Act Release No. 61334 (January 12,
2010) (SR-ISE-2009-115).
    \6\ A FXPMM is a primary market maker selected by the Exchange
that trades and quotes in FX Options only. See ISE Rule 2213.
    \7\ A FXCMM is a competitive market maker selected by the
Exchange that trades and quotes in FX Options only. See ISE Rule
2213.
---------------------------------------------------------------------------

    The Exchange is proposing to adopt an execution fee of $0.40 per
contract for all Public Customer Orders \8\ in options on BRB.\9\ The
amount of the execution fee for all Firm Proprietary orders for options
on BRB will be $0.20 per contract and the execution fee for all non-
Early Adopter ISE Market Makers in options on BRB shall be equal to the
execution fee currently charged by the Exchange for ISE Market Maker
orders in equity options.\10\ Finally, the amount of the execution fee
for all non-ISE Market Maker orders for options on BRB shall be $0.45
per contract.\11\ The

Exchange will not charge a Payment for Order Flow fee for this product.
---------------------------------------------------------------------------

    \8\ Public Customer Order is defined in Exchange Rule 100(a)(39)
as an order for the account of a Public Customer. Public Customer is
defined in Exchange Rule 100(a)(38) as a person or entity that is
not a broker or dealer in securities.
    \9\ These fees will be charged only to Exchange members. Under a
pilot program that is set to expire on July 31, 2010, these fees
will also be charged to Linkage Principal Orders (``Linkage P
Orders'') and Linkage Principal Acting as Agent Orders (``Linkage P/
A Orders''). The amount of the execution fee charged by the Exchange
for Linkage P Orders and Linkage P/A Orders is $0.27 per contract
side and $0.18 per contract side, respectively. See Securities
Exchange Act Release No. 60175 (June 25, 2009), 74 FR 32026 (July 6,
2009) (SR-ISE-2009-36).
    \10\ The Exchange applies a sliding scale, between $0.01 and
$0.18 per contract side, based on the number of contracts an ISE
market maker trades in a month.
    \11\ The amount of the execution fee for non-ISE Market Maker
transactions executed in the Exchange's Facilitation and
Solicitation Mechanisms and for Orders entered into the Price
Improvement Mechanism by the member initiating the price improvement
order is $0.20 per contract.
---------------------------------------------------------------------------

    The Exchange also proposes to waive transaction charges for all
Early Adopter Market Makers in BRB in order to further encourage
trading in this product. The Exchange believes that the revenue
generated from customer, firm proprietary and non-ISE market maker
transaction charges and increased order flow would offset the
transaction fees that would otherwise be applied to market makers in
BRB, thereby allowing the Exchange to recoup those fees while
increasing order flow and generating increased revenues.
    The Exchange believes the proposed rule change will further the
Exchange's goal of introducing new products to the marketplace that are
competitively priced.
    Finally, as a housekeeping matter, the Exchange proposes to make a
non-substantive clarifying change to its Schedule of Fees.
Specifically, the Exchange proposes to insert the words ``options on''
in certain existing fee line items to clarify that the subject fee is
applicable to options transactions.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\12\ in general, and
furthers the objectives of Section 6(b)(4),\13\ 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. The Exchange believes that the incentive plan will
generate additional order flow to the Exchange by creating incentives
to trade options on BRB as well as defray operational costs for Early
Adopter Market Makers.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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 foregoing rule change has become effective pursuant to Section
19(b)(3) of the Act \14\ and Rule 19b-4(f)(2) \15\ thereunder. At any
time within 60 days of the filing of such 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.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-ISE-2010-07 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 No. SR-ISE-2010-07. 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 changes 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 ISE. 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 No. SR-ISE-2010-07 and should be
submitted on or before March 1, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-2588 Filed 2-5-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 184 (Friday, September 21, 2018)]
[Rules and Regulations]
[Pages 47815-47817]
[FR Doc No: 2018-20107]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0619; Product Identifier 2016-SW-093-AD; Amendment
39-19408; AD 2018-19-08]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.A. (Type Certificate
Previously Held by Finmeccanica S.p.A., AgustaWestland S.p.A)
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for
Leonardo S.p.A. (Leonardo) Model AW189 helicopters. This AD requires
inspecting the tail gearbox (TGB) fitting for a crack. This AD was
prompted by a report of a crack on a TGB fitting that was found during
a scheduled inspection. The actions of this AD are intended to prevent
an unsafe condition on these products.

DATES: This AD is effective October 26, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain document listed in this AD as of October 26,
2018.

ADDRESSES: For service information identified in this final rule,
contact Leonardo S.p.A. Helicopters, Matteo Ragazzi, Head of
Airworthiness, Viale G. Agusta 520, 21017 C. Costa di Samarate (Va)
Italy; telephone +39-0331-711756; fax +39-0331-229046; or at http://www.leonardocompany.com/-/bulletins. You may review the referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX
76177. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0619.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0619; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the European Aviation Safety Agency (EASA) AD, any
incorporated-by-reference service information, the economic evaluation,
any comments received, and other information. The street address for
Docket Operations (phone:<PHONE_NUMBER>) is U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Matt Fuller, Senior Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    On February 21, 2018, at 83 FR 7423, the Federal Register published
our notice of proposed rulemaking (NPRM), which proposed to amend 14
CFR part 39 by adding an AD that would apply to AgustaWestland S.p.A
(now Leonardo) Model AW189 helicopters with tail assembly part number
(P/N) 8G5350A00131 installed. The NPRM proposed to require inspecting
the TGB fitting for a crack. The proposed requirements were intended to
detect a crack on a TGB fitting, which could reduce the tail assembly's
ability to sustain loads from the TGB and the tail rotor and result in
loss of helicopter control.
    The NPRM was prompted by AD No. 2016-0177, dated September 8, 2016,
issued by EASA, which is the Technical Agent for the Member States of
the European Union, to correct an unsafe condition for Leonardo
(formerly Finmeccanica S.p.A. and AgustaWestland S.p.A.) Model AW189
helicopters with a tail assembly P/N 8G5350A00131. EASA advises that a
crack was detected on the TGB fitting P/N 4F5350A04152 during a
scheduled inspection of an AW189 helicopter. EASA advises that this
condition, if not detected and corrected, could lead to crack
propagation up to a critical length. This condition could reduce the
assembly's ability to sustain loads from the TGB and tail rotor,
possibly resulting to reduced helicopter control. The EASA AD
consequently requires repetitive inspections of the fitting and
replacing the fitting, depending on the inspections' outcome. EASA
considers these actions to be interim and that further AD action may
follow.
    After the NPRM was published, the FAA updated AgustaWestland
S.p.A's (AgustaWestland) name to Finmeccanica S.p.A. and then to
Leonardo on its FAA type certificate. This name change is reflected in
this AD.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comment received on the NPRM and
the FAA's response.
    One commenter requested that the AD also require an inspection of
the tail rotor, tail boom, and rotor mast. The commenter does not
provide any technical support for this request.
    We disagree. The actions requested by the commenter are not
necessary to correct the unsafe condition. We have made no changes to
the rule portion of this AD.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Italy and are approved for operation in the United States. Pursuant to
our bilateral agreement with Italy, EASA, its technical representative,
has notified us of the unsafe condition described in the EASA AD. We
are issuing this AD because we evaluated all information provided by
EASA and determined the unsafe condition exists and is likely to exist
or develop on other helicopters of these same type designs and that air
safety and the public interest require adopting the AD requirements as
proposed.

Interim Action

    We consider this AD to be an interim action. The design approval
holder is expected to develop a modification that will address the
unsafe condition identified in this AD. Once this modification is
developed, approved, and available, we might consider additional
rulemaking.

Differences Between This AD and the EASA AD

    The EASA AD requires you to provide a compliance record and return
parts to Leonardo Helicopters if a crack is found on the fitting, and
this AD does not.

Related Service Information Under 1 CFR Part 51

    Leonardo has issued Bollettino Tecnico No. 189-114, dated September
6, 2016 (BT), which specifies inspecting the TGB fitting within 30
flight hours or 1 month from the receipt of the BT, whichever comes
first, and then at intervals not to exceed 150 flight hours. If a crack
is found, the BT requires replacing the TGB fitting.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 4 helicopters of U.S. Registry and
that labor costs average $85 per work-hour. Based on these estimates,
we expect the following costs:
     Inspecting the TGB fitting requires 4 work-hours and no
parts for a cost per helicopter of $340 and $1,360 for the U.S. fleet
each inspection cycle.
     Replacing the TGB fitting requires 48 work-hours and parts
cost $30,000 for a cost of $34,080 per helicopter.
    According to Leonardo Helicopters' service information, some of the
costs of this AD may be covered under warranty, thereby reducing the
cost impact on affected individuals. We do not control warranty
coverage by Leonardo Helicopters. Accordingly, we have included all
costs in our cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on helicopters identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (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);
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction; and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2018-19-08 Leonardo S.p.A. (Type Certificate Previously Held by
Finmeccanica S.p.A., AgustaWestland S.p.A.) Helicopters: Amendment
39-19408; Docket No. FAA-2017-0619; Product Identifier 2016-SW-093-
AD.

(a) Applicability

    This AD applies to Leonardo S.p.A. (Type Certificate Previously
Held by Finmeccanica S.p.A., AgustaWestland S.p.A.) Model AW189
helicopters, certificated in any category, with tail assembly part
number 8G5350A00131 installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as a crack on a tail
gearbox fitting. This condition could reduce the tail assembly's
ability to sustain loads from the tail rotor gearbox (TGB) and the
tail rotor and result in loss of helicopter control.

(c) Effective Date

    This AD becomes effective October 26, 2018.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 30 hours time-in-service (TIS) and thereafter at
intervals not to exceed 150 hours TIS, clean and inspect the TGB
fitting for a crack in the areas depicted in Figure 1 of Leonardo
Bollettino Tecnico No. 189-114, dated September 6, 2016. If there is
a crack, replace the TGB fitting before further flight.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
Matt Fuller, Senior Aviation Safety Engineer, Safety Management
Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy.,
Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email [email protected].
    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (EASA) AD No. 2016-0177, dated September 8, 2016. You may
view the EASA AD on the internet at http://www.regulations.gov by
searching for and locating it in Docket No. FAA-2017-0619.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6520, Tail Rotor
Gearbox.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Leonardo Helicopters Bollettino Tecnico No. 189-114, dated
September 6, 2016.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Leonardo S.p.A. Helicopters, Matteo Ragazzi, Head of Airworthiness,
Viale G. Agusta 520, 21017 C. Costa di Samarate (Va) Italy;
telephone +39-0331-711756; fax +39-0331-229046; or at http://www.leonardocompany.com/-/bulletins.
    (4) You may view this service information at FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-
321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Fort Worth, Texas, on September 6, 2018.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2018-20107 Filed 9-20-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: April 16, 2008 (Volume 73, Number 74)]
[Notices]
[Page 20631-20632]
[DOCID:fr16ap08-49]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0571; FRL-8360-1]

Notice of Filing of a Pesticide Petition for Residues of
Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment or modification of regulations for
residues of pesticide chemicals in or on various commodities.

DATES: Comments must be received on or before May 16, 2008

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0571 and the pesticide petition number (PP
7F7186), by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2008-0571. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Raderrio Wilkins, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions

or organize comments by referencing a Code of Federal Regulations (CFR)
part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. What Action is the Agency Taking?

    EPA is printing notice of the filing of a pesticide petition
received under section 408 of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, proposing the establishment or modification of
regulations in 40 CFR part 180 for residues of pesticide chemicals in
or on various food commodities. EPA has determined that the pesticide
petition described in this notice contains data or information
regarding the elements set forth in FFDCA section 408(d)(2); however,
EPA has not fully evaluated the sufficiency of the submitted data at
this time or whether the data supports granting of the pesticide
petition. Additional data may be needed before EPA rules on this
pesticide petition.
    Pursuant to 40 CFR 180.7(f), a summary of the petition included in
this notice, prepared by the petitioner, is included in a docket EPA
has created for this rulemaking. The docket for this petition is
available on-line at http://www.regulations.gov.

New Exemption from Tolerance

    PP 7F7186. Falcon Lab, LLC., 1103 Norbee Drive Wilmington, DE
19803, (petition submitted by Forster and Associates Consulting, LLC,
230 Steeplechase Circle, Wilmington, DE 19808), proposes to establish
an exemption from the requirement of a tolerance for residues of the
biochemical pesticide, ammonium salts of higher fatty acids [C8-C18
saturated and C8-C12 unsaturated], in or on all food commodities.
Because this petition is a request for an exemption from the
requirement of a tolerance without numerical limitations, no analytical
method is required. EPA issued a notice in the Federal Register of
August 8, 2007 (72 FR 44521) (FRL-8139-7) to exempt ammonium salts of
higher fatty acids from the requirement of a tolerance. However, the
Food Quality Protection Act (FQPA) Publicly Releasable Summary was not
present in the Docket. Therefore, EPA is republishing this notice to
allow for public comment period on this action.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: April 4, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. E8-8073 Filed 4-15-08; 8:45 am]

BILLING CODE 6560-50-S


	Office of Chemical Safety and Pollution Prevention

(7101)	EPA 712-C-16-007

October 2016

	Ecological Effects

Test Guidelines

OCSPP 850.1075:

	Freshwater and Saltwater Fish Acute Toxicity Test

NOTICE

This guideline is one of a series of test guidelines established by the
United States Environmental Protection Agency’s Office of Chemical
Safety and Pollution Prevention (OCSPP) for use in testing pesticides
and chemical substances to develop data for submission to the Agency
under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.),
the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C.
136, et seq.), and section 408 of the Federal Food, Drug and Cosmetic
Act (FFDCA) (21 U.S.C. 346a). Prior to April 22, 2010, OCSPP was known
as the Office of Prevention, Pesticides and Toxic Substances (OPPTS). To
distinguish these guidelines from guidelines issued by other
organizations, the numbering convention adopted in 1994 specifically
included OPPTS as part of the guideline’s number. Any test guidelines
developed after April 22, 2010 will use the new acronym (OCSPP) in their
title.

	The OCSPP harmonized test guidelines serve as a compendium of accepted
scientific methodologies and protocols that are intended to provide data
to inform regulatory decisions under TSCA, FIFRA, and/or FFDCA. This
document provides guidance for conducting the test, and is also used by
EPA, the public, and the companies that are subject to data submission
requirements under TSCA, FIFRA, and/or the FFDCA. As a guidance
document, these guidelines are not binding on either EPA or any outside
parties, and the EPA may depart from the guidelines where circumstances
warrant and without prior notice. At places in this guidance, the Agency
uses the word “should.” In this guidance, the use of “should”
with regard to an action means that the action is recommended rather
than mandatory. The procedures contained in this guideline are strongly
recommended for generating the data that are the subject of the
guideline, but EPA recognizes that departures may be appropriate in
specific situations. You may propose alternatives to the recommendations
described in these guidelines, and the Agency will assess them for
appropriateness on a case-by-case basis.

	For additional information about these test guidelines and to access
these guidelines electronically, please go to  HYPERLINK
"http://www.epa.gov/ocspp" http://www.epa.gov/ocspp  and select “Test
Methods & Guidelines” on the navigation menu. You may also access the
guidelines in  HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov  grouped by Series under Docket ID #s:
EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159, and
EPA-HQ-OPPT-2009-0576.

  SEQ CHAPTER \h \r 1 OCSPP 850.1075: Freshwater and saltwater fish
acute toxicity test

(a) Scope.

(1) Applicability. This guideline is intended for use in meeting testing
requirements of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) (7 U.S.C. 136, et seq.) and the Toxic Substances Control Act
(TSCA) (15 U.S.C. 2601, et seq.). It describes procedures that, if
followed, would result in data that would generally be of scientific
merit for the purposes described in paragraph (b) of this guideline.

― Hazard Evaluation; Wildlife and Aquatic Organisms, EPA 540/9-82-024,
1982) (see paragraph (j)(4) of this guideline); Standard Evaluation
Procedure: Acute Toxicity Test for Freshwater Fish (see paragraph (j)(5)
of this guideline); Standard Evaluation Procedure: Acute Toxicity Test
for Estuarine and Marine Organisms (see paragraph (j)(6) of this
guideline); EPA Pesticide Reregistration Rejection Rate Analysis:
Ecological Effects, EPA 738-R-94-035, 1994 (see paragraph (j)(7) of this
guideline); OECD 203 Fish Acute Toxicity Test, 1992 (see paragraph
(j)(3) of this guideline); and ASTM E729-96 (07), Standard Guide for
Conducting Acute Toxicity Tests on Test Materials with Fishes,
Macroinvertebrates, and Amphibians, 2007 (see paragraph (j)(1) of this
guideline).

(b) Purpose. This guideline is intended for use in developing data on
the acute toxicity of chemical substances and mixtures (“test
chemicals” or “test substances”) subject to environmental effects
test regulations. This guideline describes an acute toxicity test in
which freshwater and saltwater fish are exposed to a test substance in
static, static-renewal, or flow-through systems. For freshwater testing,
data on cold and warm water species are generally required (40 CFR 158).
Rainbow trout, Oncorhynchus mykiss, and bluegill sunfish, Lepomis
macrochirus, are the preferred species to meet this requirement for cold
and warm water tests, respectively. These species are preferred because
they are sensitive indicator species, and there is a large environmental
contaminant-response database available on them. For saltwater tests,
Menidia sp. (silversides) are the preferred species. Other species as
identified in paragraph (e)(3)(i) of this guideline may be used. The
Environmental Protection Agency will use data from this test in
assessing the hazards and risks a test substance may present in the
aquatic environment.

(c) Definitions. The definitions in OCSPP 850.1000 apply to this
guideline. In addition, the following more specific definition also
applies to this test guideline:

Death is defined as the lack of visible movement (i.e., respiratory
movements) or the lack of reaction when the caudal peduncle is touched.

(d) General considerations.

(1) Summary of test. Individuals of a particular species of fish are
exposed to the test substance and to appropriate controls (i.e.,
dilution water control and vehicle (solvent) control, if a vehicle is
used) for 96 hours, during which observations are made on organism
survival and other toxic effects. The test is designed to determine the
relationship between aqueous concentrations of the test substance and
mortality of fish over the full concentration-response curve. The
results of the test are expressed as the 96-hour median lethal
concentration (96-h LC50) and the slope of the concentration-response
relationship. Although the 96-h LC50 is the primary toxicity endpoint,
information on other signs of toxicity such as abnormal appearance and
behavior and concentration-response curves is useful in understanding
the toxic response

(2) General test guidance. The general guidance in OCSPP 850.1000
applies to this guideline except as specifically noted herein.

(3) Range-finding test. A range-finding test is usually conducted to
establish the appropriate test solution concentrations to be used in the
definitive test. In the range-finding test, the test organisms are
generally exposed to a series of widely-spaced concentrations of the
test substance (e.g., 1, 10, 100 milligrams per liter (mg/L)). The
details of the range-finding test do not have to be the same as those of
definitive testing in that the number of replicates, the number of test
organisms, and duration of exposure may be less than that used in
definitive testing. In addition, the types of observations made on test
organisms may not be as detailed or as frequently observed as that of a
definitive test.

(4) Definitive test. The primary goal of the definitive test is to
determine the 96-hour concentration-response curve for mortality, the
96-h LC50; its standard error and 95 percent (%) confidence interval;
and the slope of the concentration-response curve, its standard error
and 95% confidence interval. Where sufficient data are available, these
values are also calculated for the 24-, 48-, and 72-h
concentration-response curves. A minimum of 5 concentrations of the test
substance, plus appropriate controls, should be tested. The selected
test concentrations should bracket the 96-h LC50. Clinical signs of
toxicity such as abnormal appearance and behavior, if any, should be
reported. Analytical confirmation of dissolved test concentrations
should be performed as described in OCSPP 850.1000. Summaries of the
test conditions are presented in Table 2 of this guideline. Test
validity elements are listed in Table 3.

(5) Limit test. In some situations, it is only necessary to ascertain
that the 96-h LC50 is above a certain limit (i.e., 96-h LC50 greater
than (>) limit concentration). In a limit test, at least 7 fish are
exposed to a single “limit concentration,” with the same number of
organisms in appropriate controls. For most industrial chemicals, the
lower of 100 mg/L or the limits of water solubility or dispersion is
considered appropriate as the limit concentration. For pesticides, the
lower of 100 milligrams active ingredient per liter (mg a.i./L), when
estimated environmental concentrations are not expected to exceed 100
mg/L, or the limit of water solubility may be used as the limit
concentration.  Except for the number of test concentrations, limit
tests should follow the same test procedures, have the same duration as
the multiple-concentration definitive test (see Table 2 of this
guideline), and have both a dilution water control and a vehicle
(solvent) control, if a vehicle is used. Limit tests, like definitive
tests, should include analytical confirmation of the dissolved
concentration of the test substance. Clinical signs of toxicity such as
abnormal appearance and behavior, if any, should be reported. For
pesticides, at test termination, if any fish dies in the limit test
concentration, a multiple-concentration 96-hour test should be
conducted.

(e) Test standards.

(1) Test substance. The substance to be tested should be technical or
reagent grade unless the test is designed to evaluate a specific
formulation, mixture, or end-use product.  For pesticides, if more than
one active ingredient constitutes a technical product, then the
technical grade of each active ingredient should be tested separately,
in addition to the combination, if applicable. OCSPP 850.1000 lists the
type of information that should be known about the test substance before
testing, and discusses methods for preparation of test solutions.

	(2) Test duration. The test duration is a minimum of 96 hours.

	(3) Test organisms.

(i) Species. Data on both a warm and a cold freshwater species are
generally required for 40 CFR Part 158. If a marine or estuarine system
may be affected, data on a saltwater species are also generally
required. Freshwater and saltwater species that are recommended include:

(A) Freshwater species. Atlantic salmon, Salmo salar; bluegill sunfish,
Lepomis macrochirus; brook trout, Salvelinus fontinalis; channel
catfish, Ictalurus punctatus; coho salmon, Oncorhynchus kisutch; common
carp, Cyprinus carpio; fathead minnow, Pimephales promelas; guppy,
Poecilia reticulata; rainbow trout, Oncorhynchus mykiss; medaka, Oryzias
latipes; and zebrafish, Danio rerio.

(B) Saltwater species. Atlantic silverside, Menidia menidia; inland
silverside, Menidia beryllina; tidewater silverside, Menidia peninsulae;
and sheepshead minnow Cyprinodon variegatus;

The preferred warm water species is the bluegill sunfish. The rainbow
trout is the preferred cold water species. When data on a marine or
estuarine species are desired, a Menidia spp. (silverside) is preferred.

Juvenile fish less than (<) 3.0 grams, and old enough to be actively
feeding, should be tested. It is recommended that the wet weight and
length of at least 7 fish from the batch of fish used in a particular
test be measured and that the mean values and ranges be reported. The
longest fish should not be more than twice the length of the shortest
fish. Since these fish should not be fed during the test and 24 to 48
hours prior to test initiation, they should be of sufficient size to
survive and not exhibit signs of stress during this time period without
food.

Fish may be cultured in the laboratory, purchased from culture
facilities, or collected from the wild in a relatively unpolluted area.
Wild caught fish should be quarantined 7 days in addition to the defined
minimum holding and acclimation periods (see paragraph (e)(3)(ii)).
Whenever salmon or trout are used, they should be obtained from a
hatchery that has been certified disease-free. Fish captured by
electroshocking, chemical treatment, or gill nets should not be used.
Fish used in a particular test should be obtained from the same source
and population, be of similar age, and be of normal size and appearance.
Records should be kept regarding the source of the initial stock and/or
culturing techniques.

(ii) Holding and acclimation. Fish brought into the laboratory should be
held for a minimum of 12 days prior to use. The recommended holding
period, however, is 14 days. A minimum of 7 days of this period are used
for acclimation to environmental conditions (e.g., temperature, light
intensity, temperature, dilution water) similar to those used in the
test. To maintain organisms in good condition and avoid unnecessary
stress, they should not be crowded or subjected to rapid changes in
temperature or water quality. Acclimation water should be from the same
dilution water source as used in the test; if not, acclimation to the
dilution water should be done gradually over a 48-hour settling-in
period. Within a 24-hour period, changes in water temperature during
holding or acclimation should not exceed 3 degrees Celsius (°C), and
for saltwater species, changes in salinity change should not exceed 2
parts per thousand (ppt).

Following a 48-hour settling-in period, mortalities should be recorded,
and the following guidelines should be applied:

(A) Mortalities of greater than 10% of the population in the 7 days of
acclimation: rejection of entire batch;

(B) Mortalities of between 5 and 10% of the population during the 7 days
of acclimation: acclimation continued for additional 7 days;

(C) Mortalities of less than 5% of the population during the 7 days of
acclimation: acceptance of batch.

(iii) Health status and condition. Fish should not be used for a test:

(A) If more than 5% of the culture or acclimating group dies or shows
signs of stress (e.g., disease, physical damage, or abnormalities)
during the 48 hours preceding the test;

(B) If they have been used in a previous test, either in a treatment or
in a control group;

(C) If disease treatments were administered within 48 hours of test
initiation. Fish should not receive treatment for a disease during a
test.

(iv) Care and handling. Organisms should be handled as little as
possible, but when necessary, it should be done as carefully and quickly
as possible. Any disturbance which might change the behavior of the test
fish should be avoided. Detailed instructions for the care and handling
of fish such as those described under paragraph (j)(8) of this guideline
can be followed during the culturing, holding, acclimating, and testing
periods.

(v) Diet and feeding.  During holding and acclimation, different food
sources may be used depending on species and size (e.g., flake fish
food, pelleted food, live Artemia brine shrimp).

Test fish should not be fed during testing. During the acclimation
period, fish should be fed daily until 24 hours prior to test
initiation. If fish are larger than 0.5 grams fish should be fed until
48 hours prior to test initiation.

	(4) Administration of test substance.

(i) Preparation of test solutions. Preparation of test solutions depends
on the solubility and stability of the test substance. Guidance for
preparation of test solutions, especially for difficult or low
solubility test substances, is provided in OCSPP 850.1000. Dilution
water source and quality used in the test are described in OCSPP
850.1000 and paragraph (e)(7)(vi) of this guideline.

The concentration of vehicle solvent should not exceed 0.1 milliliters
per liter (mL/L). A previous review recommends that solvent
concentrations as low as 0.02 mL/L of dilution water be used (see
paragraph (j)(2) of this guideline).

The pH of stock solutions may be adjusted to match the pH of dilution
water or to a neutral pH if pH change does not affect the stability of
the test substance in water. The pH of test solutions may be adjusted
after the addition of the test substance or stock solution into the
dilution water. However, all pH adjustments need to be made prior to the
addition of test organisms. Hydrochloric acid (HCl) and sodium hydroxide
(NaOH) may be used for this adjustment if warranted.

See additional information about pH during testing in (e)(8)(ii).

(ii) Exposure technique. The test may be conducted using one of three
basic exposure techniques: static, static-renewal, or flow-through.
Guidance on the selection of the appropriate exposure technique is
provided in OCSPP 850.1000.

(iii) Treatment concentrations. At least 5 test solution concentrations
should be used for definitive testing, plus the appropriate control(s).
A range-finding test can be used to establish the appropriate test
solution concentrations for the definitive test (see paragraph (d)(3) of
this guideline). For scientifically sound estimates of a given point
estimate (e.g., LC50), test substance concentrations should immediately
bracket the point estimate(s) of concern. OCSPP 850.1000 provides
guidance on selection of test concentrations. For a limit test, there is
single treatment concentration, plus the appropriate control(s).
Guidance on the limit concentration is provided in paragraph (d)(5) of
this guideline.

(5) Controls. Every test includes a dilution water control and a vehicle
(solvent) control, if a vehicle is used. Controls consist of the same
dilution water, conditions, procedures, and test population as the test
solutions, except that no test substance is added.

A test is not acceptable if more than 10% of the organisms in any
control shows signs of disease, stress (e.g., discoloration, unusual
behavior, immobilization), and/or death.

(6) Number of test organisms and replicates. For definitive and limit
tests, the minimum number of fish per treatment level is 7. The use of
10 fish per treatment level and 2 replicates per treatment level is
preferred to obtain a more statistically accurate representation of the
concentration-response curve. Each test vessel should contain an equal
volume of test solution and an equal number of fish. Replicate test
vessels should be physically separated, since the test vessel is the
experimental unit.

(i) Loading. The number of fish placed in each test vessel should not be
so large as to cause the dissolved oxygen concentration to fall below
the recommended levels or affect the results of the test. In static or
static-renewal tests, loading should not exceed 0.8 grams wet weight of
organism per liter (g/L). In flow-through tests, loading requirements
will vary depending upon the flow rate of dilution water, but should not
exceed 0.5 g/L of test solution passing through the test vessel in 24
hours or 5 g/L at any time.

(ii) Introduction of test organisms. The test should be started by
introducing juvenile fish, which have been acclimated to the test
conditions, into the test vessels after the test substance has been
added. Test vessels for treatment levels should be randomly or
indiscriminately located within the test area, and test organisms should
be randomly or indiscriminately distributed among test vessels. Further
guidance is provided in OCSPP 850.1000.

(7) Facilities, apparatuses, and supplies. Normal laboratory equipment
should be used, especially the following:

(i) Facilities. Facilities for culturing, holding, acclimating, and
testing fish that are well ventilated and free of fumes and disturbances
which may affect the test organisms. There should also be flow-through
or recirculation tanks for culturing and acclimating fish. Equipment for
culturing and/or handling food sources for fish.

(ii) Environmental control equipment. Mechanisms for controlling and
maintaining the water temperature and lighting during the culturing,
holding, acclimation, and test periods. Apparatus for aerating dilution
water and removing gas bubbles as necessary. For flow-through tests,
apparatus for aerating the dilution water in the head box before mixing
with the test substance or delivery to test vessels. An apparatus
providing a 30-minute lighting transition period may be needed.

(iii) Water quality testing instruments. Equipment for determination of
water quality characteristics (pH, hardness, temperature, etc.)

(iv) Cleaning of test system. Test substance delivery systems and test
vessels should be cleaned before each test. See OCSPP 850.1000 for
further information.

(v) Test containers and delivery system. Construction materials and
equipment that may contact the stock solution, test solution, or
dilution water should not contain substances that can be leached or
dissolved into aqueous solutions in quantities that can affect the test
results. Construction materials and equipment that contact stock or test
solutions should be chosen to minimize sorption of test substances.
Refer to OCSPP 850.1000 for additional information on appropriate
construction materials. Test vessels, which should be constructed of
chemically inert material, should be of a capacity to maintain the
loading rate and environmental conditions. Test vessels should be
loosely covered to reduce the loss of test solution or dilution water
due to evaporation, to minimize the entry of dust or other particulates
into solutions, and to prevent loss of test fish. A flow-through system,
if used, should contain an appropriate test substance delivery system.

Many different sizes of test vessels have been used successfully. The
size, shape, and depth of the test vessel is appropriate if the
specified flow rate and loading requirements can be achieved.

(vi) Dilution water. Clean surface water, ground water, reconstituted
water, or natural or artificial seawater (for saltwater species) are
acceptable as dilution water if the test species will survive in it for
the duration of the culturing, holding, acclimation, and testing periods
without showing signs of stress.

Natural seawater should be filtered through a filter with a pore size of
<20 micrometers (µm) prior to use in a test. Artificial seawater can be
prepared by adding commercially available formulations or specific
amounts of reagent-grade chemicals to reagent water (deionized,
distilled, or reverse osmosis water), surface water, or ground water.
For saltwater species, a salinity should be selected from a range of 15
and 25 ppt. For artificial seawater or natural seawater that is diluted
with freshwater, salinity should be maintainable within a weekly range
of 2 ppt.

Dechlorinated tap water is not recommended (either as the freshwater
source, preparation of artificial seawater, or dilution of natural
seawater) because some forms of chlorination are difficult to remove
adequately. If dechlorinated tap water is used, recommended maximum
chlorine levels as well as other ways to demonstrate suitability as a
dilution water source are in OCSPP 850.1000.

Dissolved oxygen in the dilution water (prior to use in a test) should
be between 90 and 100% saturation. If necessary, the dilution water can
be aerated before the addition of the test substance.

For freshwater testing, hardness, alkalinity, and conductivity should be
measured in the dilution water at the beginning of the test. For
saltwater testing, salinity should be measured in the dilution water at
the beginning of the test.

Measurement of total organic carbon (TOC) or chemical oxygen demand
(COD) in the dilution water at the beginning of the test is recommended,
but at a minimum, TOC and COD should be analyzed periodically in the
dilution water source to document and characterize their magnitude and
variability. For tests with cationic substances, TOC or COD should be
measured at the beginning of the test.

Specifications for dilution water quality and constancy are described in
OCSPP 850.1000.

 (8) Environmental conditions. Environmental parameters during the test
should be maintained as specified below. The number and frequency of
measurements recommended for documenting and confirming the magnitude
and variability of water quality parameters (e.g., temperature,
dissolved oxygen, pH, and salinity) in test solutions during the test
are described in detail in OCSPP 850.1000.

(i) Temperature. Recommended test temperatures by species are shown in
Table 1. During a given test, the selected temperature should be
constant within plus or minus (±) 2 °C.

Table 1.—Recommended Test Temperatures by Species in the Freshwater
and Saltwater Fish Acute Toxicity Test

Species	Temperature (°C)

Atlantic salmon (Salmo salar)	12

Atlantic silverside (Menidia menidia)	22

Bluegill sunfish (Lepomis macrochirus)	22

Brook trout (Salvelinus fontinalis)	12

Channel catfish (Ictalurus punctatus)	22

Coho salmon (Oncorhynchus kisutch)	12

Common carp (Cyprinus carpio)	22

Fathead minnow (Pimephales promelas)	22

Guppy (Poecilia reticulata)	22

Inland silverside (Menidia beryllina)	22

Medaka (Oryzias latipes)	22

Rainbow trout (Oncorhynchus mykiss)	12

Sheepshead minnow (Cyprinodon variegatus)	22

Tidewater silverside (Menidia peninsulae)	22

Zebrafish (Danio rerio)	22

(ii) pH and salinity. The pH should be between 6.0 and 8.5 for
freshwater species and between 7.5 and 8.5 for saltwater species and
should vary less than 1 pH unit during the test within a test vessel and
between test concentrations (including control(s)). During a given test,
the salinity (selected from a range of 15 to 25 ppt) should be constant
within ± 2 ppt.

(iii) Lighting and photoperiod. A photoperiod should be selected from
regimes of 12 hours light:12 hours dark to 16 hours light:8 hours dark.
For any given test, the light regime should be constant. Light intensity
should range from 540 to1080 lux (approximately 50-100 foot-candles
(ft-c)). A 15- to 30-minute transition period between light and dark is
recommended.

(iv) Dissolved oxygen. The dissolved oxygen concentration should be
between 60 and 100% saturation during the test. If aeration is needed to
achieve an appropriate dissolved oxygen level, it should be done before
addition of the test substance. For flow-through exposures, the dilution
water may be aerated vigorously prior to delivery to the test vessels
(e.g., in the diluter head box) such that the dissolved oxygen
concentration is at or near 90 to 100% saturation. If the water is
heated, precautions should be taken to ensure that supersaturation of
dissolved gases is avoided. Aeration of the test solutions during the
test is not recommended. Gentle aeration of test vessels during the
exposure period is permitted only in cases where the dissolved oxygen
levels are in danger of dropping below 60% saturation. In such cases,
assurances should be made that the use of aeration does not stress the
test organisms; test substance concentrations should be measured during
the test to ensure that they are not affected by the use of aeration;
and all treatment and control vessels should be given the same aeration
treatment.

(v) Flow in a flow-through system. During a test, the flow rates should
not vary more than 10% between any one replicate and another. The
minimum number of test vessel volume replacements should be five per
24-hour period. It is recommended that diluter systems be monitored for
proper adjustment and operation at least twice daily throughout the test
period to better ensure that the target test concentrations are achieved
and maintained. The flow rate to each test vessel should be measured at
the beginning and end of the test.

	(9) Observations.

(i) Measurement of test substance. OCSPP 850.1000 describes the
recommended sampling methods, frequency of sampling, and sample
processing (especially of low solubility test substances) for analytical
confirmation of dissolved test concentrations and characterization of
test substance stability throughout the test. The analytical methods
used to measure the amount of dissolved test substance in a sample
should be validated before beginning the test, as described in OCSPP
850.1000, and the relevant method detection limit(s) and limit(s) of
quantification should be reported.

(ii) Test solution appearance. Observations on test solution appearance
and test substance solubility should be made daily and at the beginning
and end of the test. The appearance of surface slicks, precipitates, or
material adhering to the sides of the test vessels or in any part of the
mixing and delivery system should be recorded at a minimum at the
beginning and end of the test and during the test when the test solution
appearance changes.

(iii) Measures of effect.

(A) Mortality. The number of dead fish in each test vessel should be
counted and recorded at 24, 48, 72, and 96 hours. An observation period
at <12 hours is desirable. Dead fish should be removed from the test
vessels at the time of observation.

(B) Appearance and behavior. In addition to mortality, any abnormal
behavior or appearance, and the number of individuals exhibiting these
characteristics, should be counted and recorded at the same time as
observations of mortality.

(f) Treatment of results.

(1) Summary statistics.

(i) Mortality. The number of fish exposed at test initiation in each
treatment and replicate and the cumulative number of dead fish should be
summarized in tabular form by time of observation, treatment, and
replicate.

(ii) Appearance and behavior. The number of fish exhibiting abnormal
appearance or behavioral symptoms should be summarized in tabular form
by time of observation, treatment, and replicate.

(2) Percent mortality. The percent mortality at each treatment level and
in the controls at 24, 48, and 72 hours and at test termination (96
hours) should be calculated.

(3) Evaluation of limit test results. For pesticides, at test
termination, if any fish dies in the limit concentration, a
multiple-concentration acute 96-hour test should be conducted.

	(4) Evaluation of multiple-concentration definitive test.

(i) Concentration-response curve, slope, and LC50. Statistical
procedures should employed to calculate the 96-h LC50 (standard error
and 95% confidence interval) based upon mortality. If a
concentration-response curve model (e.g., probit) was fit to the data to
determine the LC50, the model parameters (e.g., slope) and their
uncertainty estimates (e.g., standard error) should be recorded. The
24-, 48-, and 72-h LC50 values should also be calculated if the
magnitude of the mortality allows.

(ii) No observed effect concentration (NOEC). While calculation of the
NOEC and lowest observed effect concentration (LOEC) is usually not part
of the experimental design for the regression-based definitive test,
reporting these values when possible is useful when testing industrial
and pesticide chemicals for understanding the toxic response.

(iii) Statistical methods. Statistical procedures for modeling quantal
data should be used. Additional discussion about endpoints and
statistical procedures can be found in OCSPP 850.1000.

(g) Tabular summary of test conditions. Table 2 lists the important
conditions that should prevail during the multiple-concentration
definitive test. The same conditions are recommended for a limit test,
except for differences in the number of test concentrations. Meeting
these test conditions will help ensure the satisfactory performance of
the test.

Table 2.—Summary of test conditions for freshwater and saltwater fish
acute toxicity test

Test type	Static, static-renewal, or flow-through

Test duration	96 hours

Temperature	12 °C for Atlantic salmon, Brook trout, Coho salmon,
Rainbow trout

22 °C for Atlantic silverside, Bluegill sunfish, Channel catfish,
Common carp, Sheepshead minnow, Inland silverside, Tidewater silverside,
Fathead minnow, Guppy, Medaka, Zebrafish

Constant during test within ±2 °C

Light quality	Ambient laboratory illumination

Light intensity	540-1080 lux (approximately 50-100 ft-c)

Photoperiod	Selected from among 12 hours light:12 hours dark to 16 hours
light:8 hours dark schemes

pH	Between 6.0 and 8.5 for freshwater testing; between 7.5 and 8.5 for
saltwater testing (constant during test within ±1 pH unit)

Water hardness (as CaCO3)

≤2 mg/L

Age/size of test organisms	Juvenile fish <3.0 grams

Number of test organisms per concentration	7 minimum, 10 preferred

Number of replicate test vessels per concentration	1 minimum, 2
preferred

Loading	Static or static-renewal tests: ≤0.8 g wet weight per liter;

≤0.1 mL/L for recommended solvents (see OCSPP 850.1000)

Measure of effect or measurement endpoint	96-h LC50 based on mortality

(h) Test validity elements. This test would be considered to be
unacceptable or invalid if one or more of the conditions in Table 3
occurred. These parameters are not the only elements considered when
evaluating the acceptability of a test, and it is possible that a test
could be found unacceptable or invalid based on other considerations.
However, except for the conditions listed in Table 3 and in OCSPP
850.1000, it is unlikely that a test will be rejected when there are
only slight variations from guideline environmental conditions and study
design unless the control organisms are significantly affected and/or
significant biases are introduced in defining the magnitude of effect on
measurement endpoints as compared to guideline conditions. Before
departing significantly from this guideline (such as deviating from the
organism size), the investigator should contact the Agency to discuss
the reason for the departure and the effect the change(s) may have on
test acceptability. In the test report, all departures from the
guideline should be identified, reasons for the changes given, and any
resulting effects on test endpoints noted and discussed.

Table 2.—Test validity elements for the Freshwater and Saltwater Fish
Acute Toxicity Test

1. All test vessels were not identical.

2. Treatments were not randomly or indiscriminately assigned to
individual test vessel locations, or individual test organisms were not
randomly or indiscriminately assigned to test vessels.

3. A dilution water control (and vehicle (solvent) control, if a vehicle
was used) was not included in the test.

4. More than 10% of the organisms in either the dilution water or
vehicle (solvent) controls showed signs of disease, stress (e.g.,
discoloration, unusual behavior, immobilization), and/or death.

5. Fish were fed during the test.

6. A surfactant or dispersant was used in the preparation of a stock or
test solution. (However, adjuvants may be used when testing pesticide
typical end-use products.)

(i) Reporting.

(1) Background information. Paragraph (k)(1) of OCSPP 850.1000 describes
the minimum background information to be supplied in the report.

(2) Guideline deviations. Provide a statement of the guideline or
protocol followed. Include a description of any deviations from the test
guideline or any occurrences that may have influenced the results of the
test, the reasons for these changes, and any resulting effects on test
endpoints noted and discussed.

	(3) Test substance.

(i) Identification of the test substance: common name, IUPAC and CAS
names, CAS number, structural formula, source, lot or batch number,
chemical state or form of the test substance, purity (i.e., for
pesticides, the identity and concentration of active ingredient(s)), and
radiolabeling, if any, including the location of label(s) and
radiopurity.

(ii) Storage conditions of the test chemical or test substance and
stability of the test chemical or test substance under storage
conditions if stored prior to use.

(iii) Methods of preparation of the test substance and the treatment
concentrations used in the range-finding and definitive tests, or limit
test. Identify whether the nominal concentrations are corrected or
uncorrected for purity of the test substance.

(iv) Physicochemical properties of the test substance such as water
solubility, vapor pressure, UV absorption, pKa, and Kow.

(v) If a vehicle (solvent) is used to prepare stock or test substance
provide: the name and source of the vehicle, the nominal
concentration(s) of the test substance in the vehicle in stock solutions
or mixtures, and the vehicle concentration(s) used in the treatments and
vehicle control.  If different vehicle concentrations are used at
different treatment levels, the report should, at a minimum, identify
the maximum vehicle concentration used. It is helpful to support the
vehicle choice by including a description of any measures that were
taken to identify an appropriate vehicle for use in the test, such as
the types and concentrations of vehicles used and their corresponding
effects on solubility during any preliminary work.

(vi) If a positive control is used, provide the name and source of
positive control and the nominal concentration(s) of the positive
control material in stock solutions or mixtures.

	(4) Test organism.

(i) Scientific name and common name.

(ii) Method for verifying the species.

(iii) Information about the fish used in the test: source, culture
practices, and holding and acclimation procedures and conditions,
including acclimation period, water used, feeding history, and health
status (mortality before test initiation and any preventative or disease
treatments). Feed should be analyzed periodically to identify background
contaminants such as heavy metals (e.g., arsenic, cadmium, lead,
mercury, and selenium) and persistent pesticides, especially chlorinated
insecticides.

	(iv) Age of test organisms at test initiation (mean and range).

	(v) Weight of test organisms at test initiation (mean and range).

(vi) Length of test organisms at test initiation (mean and range).

(5) Test system and conditions. Provide a description of the test system
and conditions used in the definitive or limit test and any preliminary
range-finding tests.

	(i) Description of the test vessels: size, type, material, and fill
volume.

(ii) Description of the exposure technique: static, static-renewal,
flow-through, open or closed system. If static-renewal, the frequency of
test solution renewal, and if flow-through, a description of the
flow-through system, including flow rate and test vessel turnover rate.
For closed systems, a description of the closed system design. For all
systems, a description of the calibration and validation methods.

(iii) Description of the dilution water and any water pretreatment:
source/type; temperature; salinity (saltwater); pH; hardness and
alkalinity (freshwater); dissolved oxygen; total organic carbon or
chemical oxygen demand; particulate matter; conductivity; metals,
pesticides, and residual chlorine concentrations (mean, standard
deviation, range). Describe the frequency and sample date(s) for
documenting dilution water quality and consistency.

(iv) Use of aeration, if any, and location within exposure system of
aeration (e.g., test solution or dilution water prior to test substance
addition).

(v) Number of test organisms added to each test vessel at test
initiation.

(vi) Number of test vessels (replicates) per treatment level and
control(s).

(vii) Methods used for treatment randomization and assignment of test
organisms to test vessels.

(viii) Date of introduction of test organism to test solutions and test
duration.

(ix) Loading rate.

(x) Photoperiod and light source.

(xi) Methods and frequency of environmental monitoring performed during
the definitive or limit test for test solution temperature, dissolved
oxygen, pH, salinity (if applicable), and light intensity.

(xii) Methods and frequency of measuring the dissolved test substance to
verify exposure concentrations.

(xiii) Methods and frequency of counting number of dead test organisms
and measuring any other toxic symptoms.

(xiv) For the definitive and limit tests, description of all analytical
procedures, accuracy of the method, method detection limit, and limit of
quantification.

	(6) Results.

(i) Nominal exposure concentrations and a tabulation of test substance
analytical results by treatment group and test vessel (provide raw data)
and descriptive statistics (mean, standard deviation, minimum, maximum,
coefficient of variation).

(ii) Environmental monitoring data results (test solution temperature,
dissolved oxygen, pH, salinity (if applicable), and light intensity) in
tabular form (provide raw data for measurements not made on a continuous
basis) and descriptive statistics (mean, standard deviation, minimum,
maximum).

(iii) For preliminary range-finding test, if conducted, a tabulation of
the number and percentage of dead fish in each test vessel, for all
treatment levels and control(s), at each observation period. A
description and count of any other appearance or behavioral effects, if
recorded, at each treatment level and in the control(s).

(iv) For limit test, a tabulation of the number and percentage of dead
fish in each test vessel, for the limit concentration and control(s), at
each observation period (provide the raw data) and descriptive
statistics (mean, standard deviation, minimum, maximum).

(v) For definitive test, a tabulation of the number and percentage of
dead fish, for all treatment levels and control(s), at each observation
period (provide the raw data) and descriptive statistics (mean, standard
deviation, minimum, maximum).

(vi) For limit and definitive tests, a description and tabulation of
abnormal appearance and behavioral signs of toxicity by test vessel,
treatment, and observation time (provide raw data).

		(vii) Graphs of the concentration-response data for percent mortality.

(viii) For limit test, conclusion about the 96-h LC50 being above the
limit concentration.

(ix) For definitive test, where sufficient data exist to fit a model
(e.g., probit) a tabulation of the 96-hour slope of the
concentration-response curve, its standard error and 95% confidence
interval, and any goodness-of-fit results.

(x) For definitive test, the 96-h LC50 value, its standard error and 95%
confidence interval.

(xi) For definitive test, results for the 24-, 48-, and 72-h LC50 values
if the magnitude of the mortality allows.

		(xii) For the definitive tests, the 96-hour NOEC for mortality, if
determined.

(xiii) Description of statistical method(s) used for point estimates,
including the software package for determining LC50 values and fitting
the concentration-response model, and the basis for the choice of
method. Provide results of any goodness-of-fit tests.

(xiv) Description of statistical method(s) used for NOEC and LOEC
determination, including the software package, and the basis for the
choice of method.

(j) References. The following references should be consulted for
additional background material on this test guideline.

(1) American Society for Testing and Materials. ASTM E729-96, Standard
Guide for Conducting Acute Toxicity Tests on Test Materials with Fishes,
Macroinvertebrates, and Amphibians. In Annual Book of ASTM Standards,
ASTM, West Conshohocken, PA. Current edition approved October 1, 2014.

(2) Hutchinson, T.H., N. Shillabeer, M.J. Winter and D.B. Pickford,
2006. Acute and chronic effects of carrier solvents in aquatic
organisms: A critical review. Aquatic Toxicology, 76, 69-92.

(3) Organization of Economic Cooperation and Development, 1992.
Guidelines for Testing of Chemicals, Guideline 203, Fish Acute Toxicity
Test, Adopted July 17, 1992. Updated version October 12, 2009.

(4) U.S. Environmental Protection Agency, 1982. Pesticide Assessment
Guidelines, Subdivision E, Hazard Evaluation, Wildlife and Aquatic
Organisms, EPA 540/09-82-024, U.S. Environmental Protection Agency,
Washington, DC.

(5) U.S. Environmental Protection Agency, 1985. Hazard Evaluation
Division Standard Evaluation Procedure: Acute Toxicity Test for
Freshwater Fish, EPA-540/9-85-006, Office of Pesticide Programs, Office
of Prevention, Pesticides and Toxic Substances, U.S. Environmental
Protection Agency, Washington DC. Revised June 1985.

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 ental Protection Agency, 1985. Hazard Evaluation Division Standard
Evaluation Procedure: Acute Toxicity Test for Estuarine and Marine
Organisms (Estuarine Fish 96-Hour Acute Toxicity Test), EPA
540/9-85-009, Office of Pesticide Programs, Office of Prevention,
Pesticides, and Toxic Substances, U.S. Environmental Protection Agency,
Washington DC. Revised June 1985.

(7) U.S. Environmental Protection Agency, 1994. Pesticides
Reregistration Rejection Rate Analysis: Ecological Effects, EPA
738-R-94-035, Office of Prevention, Pesticides and Toxic Substances,
December, 1994.

(8) U.S. Environmental Protection Agency, 2002. Methods for measuring
the acute toxicity of effluents and receiving waters to freshwater and
marine organisms, Fifth edition, October 2002. EPA-821-R-02-012.

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