[Federal Register Volume 87, Number 101 (Wednesday, May 25, 2022)]
[Proposed Rules]
[Pages 31794-31796]
[FR Doc No: 2022-11121]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2022-0303]
RIN 1625-AA09

Drawbridge Operation Regulation; Trail Creek, Michigan City, IN

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to modify the operating schedule that
governs the Amtrak Railroad Bridge, mile 0.9, over Trail Creek, in
Michigan City, Indiana, to allow it to operate remotely. The bridge has
operated remotely since 2003 without inclusion in the CFR and without
incident or public complaint. We invite your comments on this proposed
rulemaking.

DATES: Comments and related material must reach the Coast Guard on or
before July 25, 2022.

ADDRESSES: You may submit comments identified by docket number USCG-
2022-0303 using Federal Decision Making Portal at https://www.regulations.gov.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Mr. Lee D. Soule, Bridge Management Specialist,
Ninth Coast Guard District; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
IGLD85 International Great Lakes Datum of 1985
Left As viewed from the mouth of the river
LWD Low Water Datum Based on IGLD85
NPRM Notice of Proposed Rulemaking (Advance, Supplemental)
OMB Office of Management and Budget
Right As viewed from the mouth of the river
Sec.  Section
U.S.C. United States Code

II. Background, Purpose and Legal Basis

    The Amtrak Railroad Bridge, mile 0.9, over Trail Creek, in Michigan
City, Indiana, was authorized to operate remotely by letter during the
United States Coast Guard's transition from the Department of
Transportation to the Department of Homeland Security. Inclusion of the
Amtrak Railroad Bridge, mile 0.9, into the regulations was overlooked
and this proposed rule will correct that oversight and provide the
public the opportunity to comment on the bridge operations.
    Trail Creek is 7.3 miles long and used by small powered and
unpowered recreational vessels, commercial passenger vessels, and
fishing vessels. Freighters have not utilized the waterway for several
years. The Amtrak Railroad Bridge, mile 0.9 is a swing railroad bridge
and provides a horizontal clearance of 41 feet in the right draw and 44
feet in the left draw and a vertical clearance of 7 feet above

LWD in the closed position and an unlimited vertical clearance in the
open position. Each day during the summer, approximately 35
recreational and commercial fishing vessels transit the Amtrak Railroad
Bridge, mile 0.9; most of the 35 vessels make daily roundtrips,
transiting the bridge two times each day.
    In 33 CFR 117.401, the Amtrak Railroad Bridge, mile 0.9, is
required to open on signal except that, from December 1 through March
15 the Amtrak Railroad Bridge, mile 0.9, is required to open on signal
if a 12-hour advance notice is provided.

III. Discussion of Proposed Rule

    This proposed rule will allow the public to comment on how well the
bridge has been operated remotely for the last 19 years. The drawtender
will continue to remain in Chicago, Illinois and will be responsible
for the remote operation of two remote railroad bridges: The Amtrak
Railroad Bridge, mile 0.9, over Trail Creek and the Amtrak Railroad
Bridge, mile 3.77, over the South Branch of the Chicago River.
    The Amtrak Railroad Bridge, mile 0.9, will continue to operate a 2-
way public address system to answer calls from: (1) Vessel horn
signals; (2) a VHF-FM Marine Radio that will monitor channel 16; and
(3) cameras that will monitor the tracks, the underside of the bridge,
and the upriver and down river view of the river.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive Orders related to rulemaking. Below we summarize our
analyses based on these statutes and Executive Orders and we discuss
First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the fact that
remote operation will not significantly impact a vessel's ability to
transit the bridge; further, the bridge has operated in said manner
since 2003 without comment or complaint.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
bridge may be small entities, for the reasons stated in section IV.A
above, this proposed rule would not have a significant economic impact
on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132
(Federalism), if it has 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule will not
result in such an expenditure, we do discuss the effects of this
proposed rule elsewhere in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01, Rev.1, associated implementing
instructions, and Environmental Planning Policy COMDTINST 5090.1
(series), which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). The
Coast Guard has determined that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule promulgates the
operating regulations or procedures for drawbridges. Normally such
actions are categorically excluded from further review, under paragraph
L49, of Chapter 3, Table 3-1 of the U.S. Coast Guard Environmental
Planning Implementation Procedures.
    Neither a Record of Environmental Consideration nor a Memorandum
for the Record are required for this rule. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal Decision
Making Portal at https://www.regulations.gov. To do so, go to https://www.regulations.gov, type USCG-2022-0303 in the search box and click
``Search.'' Next, look for this document in the Search Results column,
and click on it. Then click on the Comment option. If your material
cannot be submitted using https://www.regulations.gov, contact the
person in the FOR FURTHER INFORMATION CONTACT section of this document
for alternate instructions.
    To view documents mentioned in this proposed rule as being
available in the docket, find the docket as described in the previous
paragraph, and then select ``Supporting & Related Material'' in the
Document Type column. Public comments will also be placed in our online
docket and can be viewed by following instructions on the https://www.regulations.gov Frequently Asked Questions web page. We review all
comments received, but we will only post comments that address the
topic of the proposed rule. We may choose not to post off-topic,
inappropriate, or duplicate comments that we receive.
    We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have
provided. For more about privacy and submissions in response to this
document, see DHS's eRulemaking System of Records notice (85 FR 14226,
March 11, 2020).

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority:  33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. In Sec.  117.401 Trail Creek revise paragraph (b) to read as
follows:

Sec.  117.401   Trail Creek.

* * * * *
    (b) The draw of the Amtrak Railroad Bridge, mile 0.9, at Michigan
City shall open on signal; except from December 1 through March 15, the
draw shall open if at least 12-hours advance notice is given. The
bridge is authorized to be operated remotely. The bridge shall operate
and maintain a VHF-FM Marine Radio.
* * * * *

M.J. Johnston,
Rear Admiral, U.S. Coast Guard, Commander, Ninth Coast Guard District.
[FR Doc. 2022-11121 Filed 5-24-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 171 (Wednesday, September 6, 2023)]
[Notices]
[Pages 60999-61001]
[FR Doc No: 2023-19126]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98252; File No. SR-PEARL-2023-39]

Self-Regulatory Organizations; MIAX PEARL, LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Amend Exchange
Rule 2614 of the MIAX Pearl Equities Rulebook

August 30, 2023.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 25, 2023, MIAX PEARL, LLC (``MIAX Pearl'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the 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 Exchange proposes to amend the description of Limit Orders
under Exchange Rule 2614(a)(1) to provide optional functionality that
would cancel displayed Limit Orders \3\ on the Exchange's equity
trading platform (referred to herein as ``MIAX Pearl Equities'') that
do not establish a new National Best Bid or Offer (``NBBO''), as
described below.
---------------------------------------------------------------------------

    \3\ See Exchange Rule 2614(a)(1) for a description of Limit
Orders.
---------------------------------------------------------------------------

    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/pearl at MIAX
Pearl's principal office, and at the Commission's Public Reference
Room.

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

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

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

1. Purpose
    The Exchange proposes to amend the description of Limit Orders
under Exchange Rule 2614(a)(1) to provide optional functionality that
cancel a displayed Limit Order to buy (sell) on MIAX Pearl Equities
that does not establish a new NBB (NBO), as described herein. The
Exchange intends to begin to notify Users \4\ whether their displayed
Limit Order established a new NBBO upon entry or when modified via a
Cancel/Replace message and such modification causes the order to lose
time priority.\5\ This functionality is related to a separate proposal
to adopt a fee program to be known as NBBO Setter Plus on September 1,
2023 that would provide an enhanced rebate to those displayed Limit
Orders that establish the NBBO.\6\ Users that are notified that their
displayed Limit Order or modification of such order did not establish a
new NBBO may then submit a new displayed Limit Order in an attempt to
then establish a new NBBO and qualify for the upcoming NBBO Setter Plus
program.
---------------------------------------------------------------------------

    \4\ The term ``User'' means any Member or Sponsored Participant
who is authorized to obtain access to the System pursuant to
Exchange Rule 2602. See Exchange Rule 1901.
    \5\ The Exchange intends to implement this proposed rule change
and begin to notify Users whether their displayed Limit Order
established a new NBBO upon entry or when modified via a Cancel/
Replace message on August 31, 2023 (if waiver of the operative delay
is granted) or on the effective date of this filing. See, e.g., MIAX
Pearl Equities--Updated Interface Specifications Published for
Future Enhancements--New NBBO Setter Flag and Cancellation Feature
if Order is Not Setting the NBBO, dated July 26, 2023, available at
https://www.miaxglobal.com/alert/2023/07/26/miax-pearl-equities-updated-interface-specifications-published-future, and MIAX Pearl
Equities--Previously Announced New NBBO Setter Flag and Cancellation
Feature will be available on Thursday, August 31, 2023;
Corresponding Updated Risk Protections Guide and Order Type
Combinations Guide Now on website, dated August 11, 2023, available
at https://www.miaxglobal.com/alert/2023/08/11/miax-pearl-equities-previously-announced-new-nbbo-setter-flag-and. This functionality is
limited to displayed Limit Orders because that is the only order
type offered by the Exchange that may establish a new NBBO.
    \6\ The Exchange intends to submit a separate filing with the
Commission for immediate effectiveness pursuant to section 19(b)(1)
of the Exchange Act and Rule 19b-4(f)(2) thereunder a proposal to
establish the NBBO Setter Plus Program. The Exchange notes that
other exchanges have adopted similar programs. See Securities
Exchange Act Release Nos. 95124 (June 17, 2022) 87 FR 37894 (June
24, 2022) (SR-CboeBZX-2022-034); 14923 (March 10, 2022) 87 FR 14923
(March 16, 2022) (SR-MEMX-2022-01); 68209 (November 9, 2012) 77 FR
69519 (November 19, 2012) (SR-NASDAQ-2012-126); and 89754 (September
2, 2020), 85 FR 55550 (September 8, 2020) (SR-NYSE-2020-71).
---------------------------------------------------------------------------

    In connection with the above initiatives, Users requested the
ability to instruct the Exchange to cancel their displayed Limit Order
where it does not establish a new NBBO. Therefore, the Exchange
proposes to allow Users to instruct the Exchange, on an order-by-order
basis, to cancel their displayed Limit Order to buy (sell) when that
order does not establish a new NBB (NBO) upon entry or when modified
via a Cancel/Replace message in accordance with Exchange Rule 2614(e)
and such modification results in the order losing time priority in
accordance with Exchange Rule 2616(a)(5). The proposed functionality
would be set forth under Exchange Rule 2614(a)(1)(J). For the avoidance
of doubt, the default behavior would be for the Exchange to not cancel
the order under this proposal, unless otherwise instructed to do so
upon entry on an order-by-order basis.
    The following example illustrates the proposed functionality upon
entry. Assume the NBBO is $10.00 by $10.05. A User submits a displayed
Limit Order to buy with a limit price of $10.01 and instructs the
Exchange to cancel such order should it not establish a new NBB. The
order does establish a new NBB upon entry and is posted to the MIAX
Pearl Equities Book,\7\ resulting in a new NBBO of $10.01 by $10.05.
However, such order would have been cancelled by the Exchange if its
limit price was $10.00 or lower.
---------------------------------------------------------------------------

    \7\ The term ``MIAX Pearl Equities Book'' means the electronic
book of orders in equity securities maintained by the System. See
Exchange Rule 1901.
---------------------------------------------------------------------------

    The Exchange also proposes to allow Users to instruct the Exchange
to cancel a displayed Limit Order when that order does not establish a
new NBB (NBO) after being modified via a Cancel/Replace message in
accordance with Exchange Rule 2614(e) and such modification results in
the order losing time priority in accordance with Exchange Rule
2616(a)(5). In sum, Exchange Rule 2614(e) provides that

only the price, sell long, sell short, or short exempt indicator, and
size terms of the order may be changed by a Cancel/Replace Message.
Exchange Rule 2616(a)(5) provides that in the event an order has been
modified via a Cancel/Replace message in accordance with Exchange Rule
2614(e) above, such order only retains its timestamp if such
modification involves a decrease in the size of the order, a change to
the Max Floor of an order with a Reserve Quantity, or when a Short Sale
Period, as defined in Exchange Rule 2614(g)(3)(A), is not in effect, a
change in position from (A) sell to sell short; (B) sell to sell short
exempt; (C) sell short to sell; (D) sell short to sell short exempt;
(E) sell short exempt to sell; and (F) sell short exempt to sell
short.\8\ Any other modification to an order, including an increase in
the size of the order and/or price change, will result in such order
losing time priority as compared to other orders in the MIAX Pearl
Equities Book and the timestamp for such order being revised to reflect
the time of the modification.
---------------------------------------------------------------------------

    \8\ See, e.g., Securities Exchange Act Release No. 93506
(November 2, 2021), 86 FR 61796 (November 8, 2021) (SR-PEARL-2021-
35).
---------------------------------------------------------------------------

    The following illustrates how the order from the above example
would be handled if later modified via a Cancel/Replace message that
results in a loss in time priority. As illustrated in the above
example, the displayed Limit Order to buy established a new NBBO of
$10.01 by $10.05 upon entry and now continues to rest on the MIAX Pearl
Equities Book at $10.01. Assume the away BBO is $10.00 by $10.05 and a
User submit a Cancel/Replace message to change the order's limit price
to $9.99. This would result in the away BBO of $10.00 by $10.05
becoming the new NBBO. The displayed Limit Order resting on the MIAX
Pearl Equities Book would, therefore, be cancelled because its price is
inferior to the new NBB of $10.00 and would no longer set the NBB.\9\
---------------------------------------------------------------------------

    \9\ However, such order would not have been cancelled by the
Exchange if its new limit price was $10.02.
---------------------------------------------------------------------------

    Users would need to instruct the Exchange upon entry on an order-
by-order basis to cancel their order as proposed herein. The proposed
functionality would be entirely optional and, absent an instruction
from the User on entry to the contrary, a displayed Limit Order that
does not establish a new NBBO as described above would not be cancelled
by the Exchange. Users may choose to use the proposed functionality
based on their own business needs and trading behavior.
    All Users would be notified that their displayed Limit Order or
modification to such order did not establish a new NBBO, regardless of
whether a User instructs the Exchange to cancel a displayed Limit Order
when it does not establish a new NBBO as described herein. Users that
do not inform the Exchange upon entry to cancel such order may choose
to cancel that order on their own and submit a new order in an attempt
to then establish a new NBBO and qualify for the upcoming NBBO Setter
Plus program.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of section 6(b) of the Act.\10\ Specifically, the
proposal is consistent with section 6(b)(5) of the Act \11\ because it
would promote just and equitable principles of trade, remove
impediments to, and perfect the mechanism of, a free and open market
and a national market system, and, in general, protect investors and
the public interest because it would provide Users optional
functionality to assist them in managing their order flow and attempts
to establish a new NBBO. The proposal further remove impediments to,
and perfect the mechanism of, a free and open market and a national
market system because Users may instruct the Exchange upon entry to
cancel their displayed Limit Order or modification to such order that
did not establish a new NBBO so that they may then submit a new order
to again attempt to establish a new NBBO and qualify for the upcoming
NBBO Setter Plus program. The proposal would also promote just and
equitable principles of trade because it would facilitate a User's
ability to enter orders that establish a new NBBO by enabling them to
enter a new order in a timelier manner and not submit a separate
cancellation message prior to entering the new order. The proposed
optional functionality should encourage more aggressively priced
displayed liquidity on the Exchange, thereby, improving price discovery
and potentially attracting additional contra-side order flow.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    As stated above, the proposed functionality would be entirely
optional and, absent an instruction from the User to the contrary, a
displayed Limit Order that does not establish a new NBBO as described
above would not be cancelled by the Exchange. Users may choose to not
use the proposed functionality and make their own decision whether to
cancel the order on their own based on their business needs and trading
behavior.
    Lastly, the exchange notes that at least one other exchange that
currently offers a similar NBBO Setter Plus program also provides for
the ability to instruct the exchange to cancel an order if it does not
establish the NBBO.\12\
---------------------------------------------------------------------------

    \12\ See reason code 240 on page 110 of the NYSE Pillar Gateway
Binary Protocol Specifications, dated June 27, 2023, available at
NYSE_Pillar_Gateway_Binary_Protocol_Specification.pdf. See also
Securities Exchange Act Release No. 89754 (September 2, 2020), 85 FR
55550 (September 8, 2020) (SR-NYSE-2020-71). Functionality to cancel
the order if it does not set the NBBO was not included in SR-NYSE-
2020-71.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change would
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended. The
proposed rule change would not have any impact on intramarket
competition because it would be available to all Users and Users may
choose to use the proposed functionality based on their own business
needs or trading behavior. The proposal may enhance intermarket
competition because it would allow the Exchange to better compete with
at least one other exchange that currently offers the ability to
instruct the exchange to cancel an order if it does not establish the
NBBO as part of its own NBBO Setter Plus program.\13\ The proposal may
also improve the Exchange's competitive position by encouraging the
entry of displayed orders priced more aggressively than the NBBO,
improving the Exchange's market quality, and attracting additional
liquidity. The proposal responds to the current competitive environment
where order flow providers have a choice of where to direct liquidity-
providing orders by providing optional functionality to facilitate the
entry of aggressively priced displayed liquidity on the Exchange.
---------------------------------------------------------------------------

    \13\ Id.
---------------------------------------------------------------------------

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to section 19(b)(3)(A)(iii) of the Act \14\ and Rule
19b-4(f)(6) thereunder.\15\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \15\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires the Exchange to give the Commission written notice of its
intent to file the proposed rule change, along with a brief
description and text of the proposed rule change, at least five
business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \16\ normally
does not become operative prior to 30 days after the date of the
filing. However, Rule 19b-4(f)(6)(iii) \17\ permits the Commission to
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Exchange states that
this proposal provides Users optional functionality to manage their
order flow and is designed to facilitate their ability to enter
aggressively priced displayed Limit Orders that establish a new NBBO.
The Exchange represents that a waiver of the operative delay would
permit the Exchange to offer the proposed cancellation and connected
NBBO notification functionality by September 1, 2023, the date that it
intends to begin to offer an NBBO Setter Plus program and allow it to
better compete with other exchanges that offer similar programs and
functionality. The Commission believes that waiver of the 30-day
operative delay is consistent with the protection of investors and the
public interest because the proposed functionality is optional and
could encourage more aggressively priced displayed liquidity on the
Exchange. Accordingly, the Commission hereby waives the 30-day
operative delay and designates the proposed rule change as operative
upon filling.\18\
---------------------------------------------------------------------------

    \16\ Id.
    \17\ 17 CFR 240.19b-4(f)(6)(iii).
    \18\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-PEARL-2023-39 on the subject line.

Paper Comments

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

All submissions should refer to file number SR-PEARL-2023-39. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (https://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549 on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-PEARL-2023-39 and should be
submitted on or before September 27, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-19126 Filed 9-5-23; 8:45 am]
BILLING CODE 8011-01-P


United States
Environmental Protection Agency
   Office of Chemical Safety
   and Pollution Prevention
   (7101)
EPA 712-C-024
January 2012

Ecological Effects
Test Guidelines

OCSPP 850.2200:

Avian Dietary
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 (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 http://www.epa.gov/ocspp and select "Test Methods & Guidelines" on the left side navigation menu.  You may also access the guidelines in 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.
--------------------------------------------------------------------------------

OCSPP 850.2200: Avian dietary toxicity test.
(a) Scope--
      (1) Applicability.  This guideline is intended to be used to help develop data to submit to EPA 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 the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a).
      (2) Background.  The source materials used in developing this harmonized OCSPP test guideline include the OPPT guideline under 40 CFR 797.2050 Avian Dietary Toxicity Test; OPP 71-2 Avian Dietary LC50 Test (Pesticide Assessment Guidelines Subdivision E); Avian Dietary LC50 Test Standard Evaluation Procedure; OECD 205, Avian Dietary Toxicity Test; and ASTM E 857-05e1, Standard Practice for Conducting Subacute Dietary Toxicity Tests with Avian Species.
(b) Purpose.  This guideline is intended for use in developing data, specifically both a median lethal concentration (LC50) and slope of the concentration-response, on the dietary toxicity to young northern bobwhite (Colinus virginianus) and mallard (Anas platyrhynchos) of chemical substances and mixtures ("test chemicals" or "test substances") subject to environmental effects test regulations.  While the study is specifically designed to allow calculation of the LC50, the study can be used to obtain information regarding sublethal effects which are used in Agency evaluations.  This guideline prescribes specific guidance for the testing of northern bobwhite and mallard, which are the Agency's preferred test species.  The Agency will use these data to assess acute hazard to birds.  The use of a test based primarily on lethality is justified because it presents or insures a consistent, unbiased endpoint for assessment purposes and has unambiguous ecological relevance to adverse effects.
(c) Definitions.  The definitions in the OCSPP 850.2000 guideline apply to this test guideline.  In addition, the following more specific definitions also apply to this guideline:
      Exposure period is the 5-day period during which test birds are offered a diet containing the test substance.
      Frank sublethal effects for the purpose of this study refers to overt or frank toxicological effects for birds and include, but are not limited to, decreased body weight, loss of coordination, or lethargy. Less significant sublethal effects such as ruffled appearance or muted color are not considered frank toxicological effects.
      Post-exposure period is the portion of the test that begins with the test birds being returned from a treated diet to the basal diet.  This period is typically 3 days in duration, but may be extended if birds continue to die or demonstrate other toxic effects.
      Test period is the combination of the exposure period and the post-exposure period, or the entire duration of the test.
(d) General considerations --
      (1) Summary of the test.  Birds are administered the test substance in their daily diet for five consecutive days.  Birds are observed regularly for mortality and any signs of intoxication (e.g., abnormal behavior) during the exposure period and for a period of at least 3 additional days until the test is completed.  Food consumption is estimated throughout the test.  Body weights are determined prior to initiation of exposure and at the end of the test period (at test termination).  The mortality response pattern is examined and subjected to the appropriate statistical analysis to derive the LC50, confidence limits, and slope of the concentration-response line.  Sublethal effects are also monitored, for example, gross appearance and behavior of the birds, body weights and feed consumption.  Histopathological and physiological changes should be monitored.
      (2) General test guidance.  The general guidance in the OCSPP 850.2000 guideline applies to this guideline except as specifically noted herein.
      (3) Range-finding test.  Unless the approximate toxicity of the test substance is known already, a range-finding test should be conducted to help determine the test substance concentrations to be used in the definitive test.  Refer to paragraph (e)(4)(ii) of this guideline for details on concentrations for definitive tests.  Procedures for range-finding tests may vary, but generally, groups of a few birds are fed three to five widely-spaced concentrations for 5 days.  A series of 5, 50, 500, and 5,000 parts per million (ppm) of diet (or milligrams per kilogram of diet mg/kg-diet) is suggested.
            (i) If there is no mortality at the 5,000 ppm level, and the test procedures and numbers of birds per concentration level are the same as would be used in a definitive test, and also meet the elements of an acceptable limit test (see paragraph (d)(5) of this guideline), then the range-finding test may provide sufficient information to negate the need for a definitive test.  If mortality does occur, than the results of the range-finding tests may then be used to help establish the definitive test concentrations.
            (ii) If a test substance is expected to be of low toxicity, it may be useful to first conduct a limit test at 5,000 ppm as described under paragraph (d)(5) of this guideline.  If mortality occurs at this concentration level, then further range-finding at lower levels is suggested.  The results of the range-finding test then may be used to establish the definitive test concentration levels.
      (4) Definitive test.  The goal of the definitive test is to determine the concentration-response curve for avian mortality after dietary exposure, and to establish the subacute median lethal concentration (LC50) (and its 95 percent (95%) confidence limits, as well as the slope of the concentration-response curve and its standard error).  The definitive test consists of a minimum of five dietary levels of the test substance, plus appropriate controls.  The dietary levels are confirmed by chemical analysis under test conditions.  A summary of test conditions is provided in Table 2 and validity elements for an acceptable definitive test are listed in Table 3.
      (5) Limit test.  For test substances expected to have relatively low toxicity, in place of a definitive test a limit test may be conducted with a single dietary level of 5,000 ppm test substance or the maximum expected environmental residue concentration, whichever is higher, plus a control group.  For pesticides, if the expected environmental residue concentration exceeds 5,000 ppm the test should be conducted at a higher level equivalent to the maximum expected environmental concentration (EEC) on food items (see paragraph (e)(4)(ii)(B) of this guideline).  Based on the results of the limit test, the subacute dietary LC50 may be reported as greater than the limit concentration (i.e., 5,000 ppm) provided that the following conditions are met: first the limit treatment group and control group each contain a minimum of 10 birds; second no mortality or frank sublethal effects occurs in the limit treatment group; third except for the number of treatment levels the test procedures and duration are the same as in the definitive test; fourth the concentration level in the limit treatment diet is confirmed by chemical analysis under test conditions; and fifth for pesticides, the limit dose is 5,000 ppm or the maximum expected environmental residue concentration, whichever is higher.  Signs of intoxication, if any, should be reported.  Conduct the full definitive test when any mortality is observed at the limit concentration.  If sublethal effects are suspected in the study then the Agency should be consulted for discussion on the appropriate dose and conduct of the limit test.
(e) Test standards --
      (1) Test substance.  The substance to be tested should be technical grade unless the test is designed to test 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.  The OCSPP 850.2000 guideline lists the type of information that should be known about the test substance before testing and discusses methods for preparation of the test substance in the diet for use in testing.  The Agency should be contacted prior to testing with nanomaterials.
      (2) Test duration.  The definitive and limit tests consist of 5 days of exposure to the test substance in the diet (exposure period) followed by at least 3 days of additional observation (post-exposure period) while the test birds are receiving an untreated diet.  If any test birds die during the second or third day of the post-exposure period, if toxic signs are evident on the third day of the post-exposure period, or if the test substance is expected to have delayed effects, the test period should be extended until there are two successive post-exposure days without mortality and one day without signs of intoxication.
      (3) Test organism --
            (i) Species.  Data on both an upland game bird and a waterfowl are generally required for 40 CFR Part 158.  These test protocols and standards describe tests specific to using the northern bobwhite (Colinus virginianus (L.)) for an upland game bird, and the mallard (Anas platyrhynchos (L.)) for a waterfowl.  In addition to these species, which are tested at a minimum, additional species, such as pigeon (Columba livia); Japanese quail (Coturnix coturnix japonica); ring-necked pheasant (Phasianus colchicus); and red-legged partridge (Alectoris rufa), may also be used as upland game birds.  The Agency will use these and other data to assess acute hazards and risks to birds.  Other sources should be consulted for appropriate husbandry standards for use of these other species in this test.  For tests with species other than the northern bobwhite or mallard, it is important that they are responsive to the conditions of the test and cannot avoid exposure to the test substance through fasting.  See paragraph (e)(3)(iii) of this guideline for additional guidance.
            (ii) Source.
                  (A) Birds may be reared in the laboratory or purchased from a breeder.  For a satisfactory test, all control and treatment birds used in a test should be from the same source and hatch.  Birds should be obtained only from sources whose colonies have known breeding histories.  Test birds should be phenotypically indistinguishable (except for size) from wild stock.  It is recommended that birds be obtained from flocks that have been out bred periodically with genetically wild stock in order to maintain a genetic composition that approximates the natural heterogeneity of the species.  Birds purchased from a breeder should also be certified as disease-free or as bred from disease-free stocks.
                  (B) If northern bobwhites are purchased, it is preferable that they be obtained as eggs which then are hatched and reared in the testing facility.  During incubation, a temperature of 39 degrees Celsius ([o]C) and relative humidity of 70% are recommended for northern bobwhite.  It is feasible to purchase live young northern bobwhite chicks if they can be obtained locally, however, young northern bobwhite may suffer adverse effects if shipped by air or other commercial means.  Young mallard ducklings normally can be shipped without undue adverse effects.
            (iii) Age.
                  (A) Young birds that are not too old to be able to avoid eating during the exposure phase of the test (i.e. 5 days).  This is typically achieved if at the beginning of the exposure period mallards are 5 days old and northern bobwhites are 10 to 14 days old.  If additional test species are used, it is important that the test animals are not able to survive for five days without eating.  This will insure that the animals cannot fast during the test, and that the test actually measures the toxicity of the test substance, rather than avoidance.  Prior to conducting any testing on alternate species, confirm through studies or a literature search that the test animals are not old enough to survive without feeding for five days.
                  (B) For a satisfactory test all birds used in a test should be the same age, plus or minus (+-1) a day.  Due to the difficulty of sexing young birds, the sex of the test animals is not determined.
            (iv) Acclimation.  Test birds should be acclimated to test facilities and basal diet for a minimum of 3 days for mallard and 7 days for northern bobwhite.  Acclimation to test pens may be either in the actual pens used in the test or in identical pens.
            (v) Health status.  Birds used in the test should be in apparent good health.  Deformed, abnormal, sick, or injured birds should not be used.  During the 3-day period preceding testing, the health of the populations should be monitored and mortalities recorded.  Birds should not be used for a test if more than 5% of the individuals in the total test population die during this time.  Birds should not have been selected in any way for genetic resistance to toxic substances or have been used in a previous test, either in a treatment or control group.
            (vi) Care and handling.  During holding, acclimation, and testing, birds should be shielded from excessive noise, activity, or other disturbance.  Test birds should be handled as little as possible to conform to test procedures.
            (vii) Diet and feeding.
                  (A) A standard commercial game bird (for northern bobwhite) or duck (for mallard) starter mash, or the nutritional equivalent, should be used for diet preparation.  Guidance for recommended nutritional values is provided in Table 1.
              Table 1. -- Recommended nutritional values for feed
                             Nutritional Component
                             Recommended Range (%)
                                 Crude protein
                                   27 to 29
                                  Crude fiber
                                  3.5 to 5.0
                                   Crude fat
                                  2.5 to 7.0
                                    Calcium
                                  2.6 to 3.6
                                  Phosphorus
                                  0.9 to 1.1
                  (B) Feed should not be used past its normal shelf life.  Antibiotics or other medication should not be used in the diet during the acclimation period or the test.  For bobwhite only, an antibiotic demonstrated to fully depurate in 72 hours may be added to the drinking water up to 72 hours before test exposure, if necessary, for birds up through 10 days of age.  It may not be possible to obtain food that is completely free of pesticides, heavy metals, and other contaminants; however, diets should be analyzed periodically, as described under paragraph (e)(9)(ii) of this guideline, and selected to be as free from contaminants as possible.  Extra precautions should be taken when fish meal or oil is a major ingredient, since fish are often contaminated with high levels of chlorinated hydrocarbons.
            (viii) Water.  Only clean unmedicated water should be offered during the 96 hours preceding the exposure period and during the test period.  Clean water should be available ad libitum.  Water bottles or automatic watering devices are recommended.  If water pans or bowls are used, water should be changed at least once a day.
      (4) Administration of test substance.  The test substance is administered in the diet with ad libitum feeding.
            (i) Preparation of diet treatments.
                  (A)  The test substance is mixed into the diet in a manner that will result in even distribution of the test substance throughout the diet.  Diets can be mixed by commercial, mechanical food mixers.  For many test substances, it is recommended that treated diets be mixed under a hood.  Mashes and test substances should be mixed freshly just prior to the beginning of the test.  Certain volatile or other test substances may require preparation of fresh diets at frequent intervals.  The Agency should be contacted prior to testing with nanomaterials.  Analysis of the diet for test substance concentrations is conducted as described under paragraph (e)(9)(i) of this guideline.
                  (B) If possible, test substance should be added to the diet without the use of a diluent.  If a diluent is needed, the preferred diluent is distilled water, but water should not be used as a diluent for test substances known to hydrolyze readily.  When a test substance is not water soluble, it may be dissolved in a reagent grade evaporative diluent (e.g. acetone or methylene chloride) and then mixed with the test diet.  The diluent should be completely evaporated prior to feeding.  Other acceptable diluents may be used; these include table grade corn oil, propylene glycol, and gum arabic (acacia).  If a diluent is used, it should not comprise more than 2% by weight of the treated diet, and an equivalent amount of diluent should be added to control diets for untreated birds.
            (ii) Treatment concentrations.
                  (A) At a minimum five concentrations of the test substance in the diet are tested in the definitive test, plus the appropriate control.  These dietary concentrations should be spaced geometrically in such a manner so that the entire concentration-response curve (LC10 to LC90) is adequately characterized.  Taking into account results of the range-finding test(s), dietary levels should be spaced so that at least three concentrations cause mortality between, but not including, 0% and 100%.  For a scientifically sound estimate of a point on the curve (e.g., LC50), responses should immediately bracket the point estimate of concern.  For some test substances, it may be necessary to use more than five dietary levels to achieve these results.
                  (B) For a limit test, there is single dietary level, plus the appropriate control (see paragraph (d)(5) of this guideline). A limit dose of 5,000 ppm is used unless environmental residues are expected to result in a higher dietary concentration.  To calculate the dietary limit concentration (mg a.i./kg-diet) for spray applications of pesticides Equation 1 of this guideline can be used where a use is limited to a single application per year and Equation 2 of this guideline can be used where there are multiple applications per year.  The dietary residue estimates are based on a nomogram that relates food item residues to pesticide application rate; for an application rate of 1 lb a.i./A the highest residue level expected is with short grass (nomogram value of 240).  The nomogram is based on an EPA database called UTAB (Uptake, Translocation, Accumulation, and Biotransformation), a compilation of actual measured pesticide residue values on plants (see references in paragraphs (j)(3) and (j)(4) of this guideline).  If there are multiple uses this study is supporting for registration, the limit concentration for the study should be based on the one resulting in the highest dietary exposure.
      where:
            for a pesticide use with a single application per year:
		Equation 1
      for a pesticide use with more than one application per year:
		Equation 2
      ApRate = maximum single application rate (in lb a.i./acre);
      Halflife = the foliar halflife (default is 35 days);
      Interval = the minimum application interval (in days);
      i = application event from 1 to n;
      n = total number of applications

      (5) Controls.
            (i) Every test includes a negative control group.  For a satisfactory test, negative control birds should be from the same hatch as the test substance dosed groups and be kept under the same experimental conditions.  The test procedures should be the same for control and treated birds, except that no test substance should be added to the diets of control birds.  If a vehicle is used in preparation of the test diets, the same vehicle should be added to the diets of control birds in the highest concentration used for test diets.
            (ii) Controls serve as a monitor of bird husbandry practices and an indicator of possible problems due to handling and test substance administration and aid in separating treatment related effects from non-treatment related effects.  Controls are important in assessing background mortality and disease.  Background mortality is never presumed to be negligible.
            (iii) A test is unacceptable if more than 10% of the negative control birds die during the test period.
      (6) Number of test organisms and replicates.
            (i) The minimum number of birds for each dietary test substance level and the control is 10 young birds.  Birds may be divided into two replicates with a minimum of five birds per replicate.  Equal numbers of birds should be used for each treatment level.  When a test substance is known or expected to result in high experimental variation, it may be appropriate or necessary to use additional birds.
            (ii) For a satisfactory test, birds should be randomly assigned to treatment and control pens without respect to sex.  Randomization may be done either at the initiation of the acclimation period or at the time when the birds are weighed at the beginning of the exposure period.  The latter is recommended because it avoids additional handling stress.
      (7) Facilities, apparatus and supplies.  Normal laboratory equipment and supplies, and items especially listed in (e)(7)(i) through (e)(7)(iv).
            (i) Facilities.  Pens should be kept indoors to control lighting, temperature, and other environmental variables.
            (ii) Pens --
                  (A) Size.  Pens for housing young birds should have a floor area of at least 300 square centimeters per bird (cm[2]/bird) (approximately 50 square inches per bird (in[2]/bird)) for northern bobwhite quail and at least 600 cm[2]/bird (approximately 100 in[2]/bird) for mallards.
                  (B) Construction materials.  Tests should be conducted with birds being maintained in commercial brooder pens or pens of similar construction.  Pens should be constructed of galvanized metal, stainless steel, or perfluorocarbon plastics.  Materials that are toxic, may affect toxicity, or may sorb test substances should not be used.  Wire mesh should be used for floors and external walls; solid sheeting should be used for common walls and ceilings. Wire mesh for floors should be fine enough so as to not interfere with the normal movement of young birds.
                  (C) Pen placement to prevent cross-contamination of feed.  Where feasible, it is recommended that pens not be stacked upon each other.  If pens are stacked, only one test substance is allowed in any single stack.  Pens should be randomly arranged, whether or not in a stack, with respect to dose levels and controls.  Pens, such as stacked, unmodified, commercial pens with external feeders, that allow food to be spilled from one pen to a lower pen, should be avoided.  Any modifications that prevent cross contamination of concentration levels are acceptable.  For example, commercially available, 30 cm (1 ft) long chick feeders may be placed inside the pens and be covered with 1.27 cm (0.5 in) mesh hardware cloth over the food, for northern bobwhite.  The same feeders covered with approximately 2.5 cm (1 in) mesh wire are appropriate for mallards.  For either species, external feeders can be covered with the appropriate size wire mesh and a solid piece of metal extended from the bottom of the cage to a point exterior to the feeder.  Spillage may occur, but the added metal will prevent food from spilling into another feeder.
                  (D) Pen placement to prevent cross-contamination of volatile substances.  In order to avoid cross-contamination for test substances that volatilize or otherwise forms aerosols or vapors in the air; no more than one test substance is tested in a room.
                  (E) Cleaning.
                        (1) Between tests, pens should be disassembled (if feasible) and thoroughly cleaned to prevent disease transmission and cross-contamination.  Steam cleaning of cages is recommended.  Cages may be hosed, brushed thoroughly, and hosed again, as an alternative method.  The use of detergents or bleach is acceptable, but other chemical disinfectants such as quaternary ammonium compounds should not be used.  When disease vectors have to be controlled, hot or cold sterilization techniques are recommended, as long as such techniques will not leave chemical residues on the cages.  For cold sterilization, ethylene oxide is recommended.
                        (2) Depending upon the type of pens used, pens may be cleaned during a test as needed to maintain good animal husbandry; however, take care to minimize disturbance of the birds.
            (iii) Disposal.  After the test is terminated, treated and positive control birds should be sacrificed and disposed of properly. Negative control birds may be kept as breeding stock, but they should not be used in any other tests.
            (iv) Cleaning.  All materials that will come in contact with the test organisms and test substance should be cleaned before use.  Cleaning procedures should be appropriate to remove known or suspected contaminants.
	(8) Environmental conditions --
            (i) Temperature.  Testing is done indoors to control temperature and other environmental variables.  Pens should be heated, preferably by thermostatic control.  A temperature gradient in the pen of approximately 38 degrees Celcius ([o]C) to approximately 22 [o]C will allow young birds to seek a proper temperature.  Temperature requirements for young birds typically decline over this range from birth through the first several weeks of life.
            (ii) Humidity.  Relative humidity is not as critical as some other variables, but ideal test conditions include a relative humidity between 45 and 70%.
            (iii) Lighting and photoperiod.  A photoperiod of 14 hours light and 10 hours dark provides sufficient light to promote the feeding of the young birds and is recommended.  Continuous lighting is also acceptable.  Lighting may be either incandescent or fluorescent.  Pens and lights should be positioned so that all pens will receive similar illumination.
            (iv) Ventilation.  It is recommended that ventilation be sufficient to supply 10 to 15 air exchanges per hour.
      (9) Observations --
            (i) Measurement of test substance in diet --
                  (A) Sampling.  Samples of treated diets are analyzed to confirm proper dietary concentration of the test substance under test conditions using analytical methods that are validated before beginning the test as described in the OCSPP 850.2000 guideline.  Representative samples of test feed should be taken at a minimum from feeders of the high, middle, and low test concentrations, at the beginning and end of the test.
                  (B) Stability. If it is observed that the stability or homogeneity of the test substance in the diet cannot be maintained, care should be taken in the interpretation of the results of the study and note made that the results may not be reproducible.  For a satisfactory test, test substance concentration in the diet should be maintained at least at 80% of the nominal concentration throughout the exposure period (i.e., first 5 days of the test).
            (ii) Contaminants in feed.  Contaminated feed may compromise study results, therefore, 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.  A broader pesticide screen to include other chemicals known to be acutely toxic to birds may be useful.
            (iii) Basal diet composition.  A nutrient analysis of the basal diet should be included in the test report.  Most commercial feed companies provide both the analysis and the list of supplements on the basal feed label.  The analysis should include percent by weight of protein, fat, fiber, ash, calcium, and phosphorus.
            (iv) Environmental conditions --
                  (A) Temperature.  Temperature should be monitored on a constant basis in at least one representative location.
                  (B) Humidity.  Humidity should be monitored on a constant basis in at least one representative location.
            (v) Measures of effect --
                  (A) Monitoring of birds.  Observation of test birds should be made, at a minimum, 3 times on the first day of the exposure period.  Observations also should be made at least daily throughout the remainder of the test period; twice daily observations are recommended, where feasible.
                  (B) Mortality, intoxication, and other abnormal behavior.  Throughout the test period, all signs of intoxication, other abnormal behavior, and mortality are identified, enumerated and recorded by treatment level and by day.  Signs of intoxication are those behaviors apparently due to the test substance and may include a wide array of behaviors, such as labored respiration, leg weakness, hemorrhage, convulsions, and ruffled feathers, etc.  Record all signs of intoxication and any other abnormal behavior, such as excessive aggression, toe-picking, etc. that may or may not be attributed to the test substance.  Among survivors, remission of signs of intoxication and cessation of abnormal behavior is identified and recorded by treatment level and by day.  An estimate of the number of birds exhibiting such signs should be recorded for each treatment level.
                  (C) Body weight.  Average body weight of birds is determined and recorded for each pen within each test substance treatment and control group at the beginning and end of the exposure period and at the end of the normal 3-day post-exposure period.  If the study is continued beyond 8 days, body weight data should be recorded at least weekly and at the termination of the test.  Body weight data at 72 hours before the exposure period are not essential, but would provide valuable base-line data.
                  (D) Food consumption.  Measure and record food consumption daily in control pens and pens with the low, middle, and high test substance concentration levels for both the exposure period and the normal 3-day post-exposure period.  For other pens, estimate food consumption for the exposure period and for the post-exposure period.  If the study is continued beyond 8 days measure and record food consumption weekly.  Estimate and record any significant amount of food spilled onto litter pans.
                  (E) Gross pathology.  Gross pathology examinations are conducted on all birds that die, as well as a sufficient number of survivors selected randomly in all test substance treatment groups as well as at least three control survivors in order to provide characterization of lesions.
(f) Treatment of results--
      (1) Descriptive summary statistics--
            (i) Environmental conditions.  Calculate descriptive statistics (mean, standard deviation, coefficient of variation, minimum, maximum) temperature and humidity.
            (ii) Mortality.  Cumulative number of dead for each test substance treatment level and control group by observation day should be summarized in tabular form.
            (iii) Body weight.  For a given observation time, calculate the average body weight for a given pen using Equation 3.  Calculate the change in average body weight for each pen between observation periods (see Equation 4) and calculate the total change in average body weight between test initiation and test termination (Equation 4 where time j is test termination and time i is test initiation).  Calculate and plot treatment mean body weight change and standard error by observation interval to assess effects on the pattern of weight change.  Calculate and plot treatment mean total body weight change and standard error.
		Equation 3
      where:
       = average weight of a bird in a given pen at observation time t;
       = total weight of birds in the pen at time t;
       = total number of birds in the pen at time t.

		Equation 4
      where:
             = difference or change in average bird weight for a pen between observation time i and j;
       = average weight per bird in the pen at time i;
       = average weight per bird in the pen at time j.
            (iv) Food consumption.  Calculate and plot the mean food consumption by treatment level and observation period.
            (v) Appearance and behavior.  Number of birds with appearance and behavioral symptoms should be summarized in tabular form by time of observation, treatment and pen.  Tabulate among survivors, remission of signs of intoxication and cessation of abnormal behavior by test substance treatment level, pen, and by observation day.
            (vi) Gross pathology.  Types of observed pathologies and the number of dead or examined surviving birds with these lesions should be summarized in tabular form by test substance treatment level and pen.
      (2) Percent mortality.  Calculate the cumulative percent of dead birds at each test substance treatment level and in the controls at test termination.  Test substance treatment data should be adjusted to account for any control mortality.
      (3) Limit test --
            (i) LC50 value.  At test termination, if no birds die at the limit concentration, the subacute dietary LC50 is considered to be greater than the limit concentration (i.e., LC50 > dietary limit concentration).  This is because the Binomial theorem predicts that when 10 organisms are tested, the probability of seeing no mortality if the true LC50 is at or below the limit concentration is <0.001.  Conversely the probability of seeing one or more dead birds if the true LC50 is at or below the limit concentration is >0.999.
            (ii) Proportion of mortality ().  The Binomial Theorem can also provide both an estimate of the true proportion of mortality () in the laboratory test population as well as confidence bounds on that estimate (see Table A4 of the reference in paragraph (j)(2) of this guideline).  For small sample sizes the interval may be large.  For example, for no mortalities in 10 birds ( = 0), the upper 99% confidence bound on the estimate of  is (0.00, 0.41) and 95% confidence interval is (0.00, 0.31).  Using the 95% confidence interval as an example, the true (unknown) proportion of mortality will be covered by the calculated confidence interval in 95% of repeated trials.  For assessing risks, the confidence in the proportion impacted is considered in determining acute effects at environmental exposure doses.  If the uncertainty in  is high at the limit concentration, and the expected environmental exposure concentration is close to the limit concentration, risks to threatened and endangered species may not be able to be discounted.
            (iii) Multiple-dose definitive testing.
                  (A) At test termination, if one or more mortalities occur among the 10 birds at the limit concentration (which was conducted at 5,000 ppm or the maximum EEC, whichever is greater), a definitive LC50 test should be conducted.  If frank sublethal effect(s) are observed in one or more birds at the limit dose, despite an absence of mortality, then a full definitive test may be necessary. For pesticides if frank sublethal effect(s) are observed in one or more birds and the limit dose tested was: 1) less than ten times the maximum expected EEC, then a full definitive study is necessary; or 2) was at least ten times the maximum EEC, but there is other evidence or data that indicate a risk to avian species, e.g., pesticide use incident data, then a full definitive test is necessary.

                  (B) A multiple-dose definitive LD50 test may be waived if, at test termination: 1) the limit treatment group and control group each contain a minimum of 10 birds; 2) no birds died at the limit dose; 3) there are also no frank sublethal effect(s) at the limit dose; 4) the concentration level in the limit treatment diet is confirmed by chemical analysis under test conditions; 5) except for the number of treatment levels the test procedures and duration are the same as in the definitive test; 6) for pesticides, the limit dose was 5,000 ppm or equivalent to the maximum expected environmental concentration on food items, whichever is higher.
 	(4) Multiple-dose definitive test--

            (i) Concentration-response curve, slope and LC50.  Statistical procedures are employed to calculate the LC50 (standard error and 95% confidence limits).  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.  A statistical test for goodness-of-fit (e.g., chi-square test) should also be performed to determine how well the data fit the computational model used.
            (ii) NOEC.  While calculation of a NOEC and LOEC is usually not part of this test design for acute tests, reporting these values is useful when testing pesticides and industrial chemicals.
            (iii) Statistical methods.  Statistical procedures for modeling quantal data are available and should be used.  Additional discussion about endpoints and statistical procedures is found in the OCSPP 850.2000 guideline.
(g) Tabular summary of test conditions.  Table 2 lists the important conditions that should prevail during the definitive test.  Except for the number of treatment levels, Table 2 also lists the important conditions that will prevail during a limit test.  Meeting these test conditions will greatly increase the likelihood that the completed test will be acceptable or valid for the purposes of this test.

	Table 2. -- Summary of Test Conditions for Avian Subacute Dietary Toxicity Test
Test duration
Minimum of 8 days
Exposure period
Five days
Temperature
Gradient in a pen of 22 [o]C to 38 [o]C
Light quality
Ambient: incandescent or fluorescent
Photoperiod
14 hours light: 10 hours dark
Pen size
>300 cm[2]  (approximately 50 in[2]) per bird for northern bobwhite and >600 cm[2] (approximately 100 in[2]) per bird for mallards
Number of pens
One or two per dose level
Test species
Northern bobwhite and mallard are preferred
Age of test organisms at test initiation
Northern bobwhite: 10 - 14 days
Mallard: 5 days
Sex of test organisms
Typically both sexes should be tested; however it is not practical to determine the sex of young birds
Number of birds per concentration level
Minimum of 10, randomly assigned
Concentration levels
Minimum of five, plus control for definitive test
(for limit test, the limit concentration (5,000 ppm or higher) plus a control)
Administration of test substance
Through diet
Measures of Effect (Measurement Endpoint)
Death (LC50), body weight, food consumption and other signs of clinical toxicity
(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.  This list should not be misconstrued as limiting the reason(s) that a test could be found unacceptable or invalid.  However, except for the conditions listed in Table 3 and in the OCSPP 850.2000 guideline, it is unlikely that a study will be rejected when there are slight variations from guideline environmental conditions and study design unless the control organisms are significantly affected, the precision of the test is reduced, the power of a test to detect differences is reduced, 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, communication between the investigator and the Agency is important in order to discuss the reason for the departure and the effect the change(s) will have on test acceptability. In the test report, all departures from the guideline are identified, reasons for these changes given, and any resulting effects on test endpoints noted and discussed.
	Table 3. -- Test Validity Elements for Avian Subacute Dietary Toxicity Test

1.  Birds were not randomly assigned to treatment and control pens.
2.  More than 10% of the control birds died or became moribund during the test.
3.  Concentrations of the test substance were not satisfactorily maintained in the diet (levels should be at least 80% of the nominal concentration) throughout the exposure period (i.e., the first 5 days).
4.  Birds were not administered the test substance in their daily diet for 5 consecutive days.
5.  A minimum of 10 young birds were not used for each dietary concentration of the test substance.
6.  The test substance was not administered in the diet.
--------------------------------------------------------------------------------
7.  In the definitive test a minimum of five dietary levels of the test substance, plus appropriate controls, were not tested.

(i) Reporting--
      (1) Background information.  Background information to be supplied in the report consists at a minimum of those background information items listed in paragraph (j)(1) of the OCSPP 850.2000 guideline.
      (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 which may have influenced the results of the test, the reason 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, and its purity (i.e. for pesticides, the identity and concentration of active ingredient(s)), radiolabeling if any, 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, stock solutions, and the treatment concentrations used in the range-finding and definitive test, or limit test.
            (iv) If a diluent is used to prepare stock or test substance provide: the name and source of the diluent, the nominal concentration(s) of the test substance in the stock solution, and the diluent concentration(s) used in the treatments and diluent control.
            (v) Name of toxicant used for positive control (if applicable), dietary treatment levels.
	(4) Test organisms.
      (i) Name of species tested (including scientific name).
            (ii) Information about the source:  type, name, breeding history, certification of disease status.
		(iii) Age of birds (in days) at the beginning of the test.
            (iv) Average body weight for each pen at the beginning of the test, at the end of the exposure period, and at the end of the test.
            (v) Acclimation procedures and conditions, including housing and environmental conditions (if different from test conditions), feeding procedures, and health observations (including mortality).
      (5) Test methods and conditions.  Provide a description of the test system and conditions used in the definitive or limit test, any preliminary range-finding tests, and any positive control (see 850.2000 (h) Reference toxicants) tests.
		(i) Description of housing containers: including type, size, and material of pens.
		(ii) Description of feed and water dispensing apparatus.
            (iii) Description of placement of pens to eliminate cross-contamination, due either to food cross-contamination or volatility of test substance.  Include a description of any modifications of food dispensers that prevent cross-contamination.
            (iv) Description of housing environmental conditions: temperature, humidity, ventilation rate, photoperiod, and lighting source and intensity.
            (v) Detailed description of basal diet, including source/type, percent by weight of protein, fat, fiber, ash, calcium, and phosphorus, a list of expected amounts of vitamins, minerals or other supplements.  Most commercial feed companies provide both the analysis and the list of supplements on the label.
            (vi) Describe the frequency and sample date(s) for documenting the contaminant status (heavy metals, persistent or chlorinated pesticides) of the feed and tabulation of the results of the analysis.
		(vii) Number of birds added to each pen at test initiation.
		(viii) The number of pens per test substance dose level and control.
		(ix) Methods of assigning birds to test pens and test pens to treatment levels.
            (x) Date of initial exposure of birds to the test substance, dates of exposure, duration of test, including length of exposure period (in days) and length of the post-exposure period on "clean" feed (in days).
            (xi) Methods and frequency of environmental monitoring performed during the definitive or limit study for temperature and humidity.
            (xii) Methods and frequency of measuring test substance to confirm dietary exposure levels of the test substance and in control feed.
            (xiii) For the definitive and limit test, all analytical procedures should be described.  The accuracy of the method, method detection limit, and limit of quantification should be given (described in 850.2000 (b) Definitions).
            (xiv) Methods and frequency of measuring number of dead birds, observing signs of intoxication, including regurgitation, and other abnormal behavior, including time of onset, duration, severity, and number affected at each dose level and control.
            (xv) Estimated food consumption per pen daily in control pens and pens with the low, middle, and high test concentration levels.  For other pens, food consumption should be estimated for the exposure period and for the post-exposure period.  Indicate whether food was regurgitated or spilled and in which treatments.
      (6) Results.
            (i) Tabulation of dietary test substance analytical results by pen and treatment (provide raw data).  Include a statement about the stability and homogeneity of the test substance in the diet throughout the exposure period.
            (ii) Environmental monitoring data results (temperature, humidity) 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 tests, if conducted, tabulate the number and percentage of birds that died in each test pen, treatment level and in the control at each observation period.  Provide a description and count of any other appearance or behavioral effects at each treatment level and in the control.  Tabulate the results of gross pathological examinations in dead and samples of surviving birds.
            (iv) For a limit test, tabulation for the limit concentration treatment and the control the number of dead birds in each pen at each observation time during the test (provide the raw data).
            (v) For the definitive test, tabulation by test pen and treatment of the number of dead birds at each observation time during the test (provide the raw data).
            (vi) For the definitive test, tabulation of the treatment percent dead, adjusted for control mortality.
            (vii) For the limit and definitive test, tabulation by test pen, treatment and observation time of abnormal appearance and behavioral signs of toxicity and recovery, if any (provide raw data).
            (viii) For the limit and definitive test, tabulation by test pen, treatment gross morphology of dead birds and samples of surviving birds at test termination (provide raw data).
		(ix) Graphs of the dose-response data for percent mortality.
            (x) For a limit test, provide conclusion about the LC50 being above the limit concentration and the lack or presence of other signs of toxic effects at the limit concentration.
            (xi) For the definitive test, where sufficient data exist to fit a model (e.g. probit) the slope of the dose-response curve and its standard error and 95% confidence limits and any goodness of fit results
		(xii) If determined for the definitive test, the NOEL for mortality.
            (xiii) Description of statistical method(s) used for point estimates, including software package, for determining the LC50 value, fitting the dose-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 NOEL and LOEL determination, including 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 E 857-05e1, Standard Practice for Conducting Subacute Dietary Toxicity Tests with Avian Species. In Annual Book of ASTM Standards, Vol. 11.06, ASTM, West Conshohocken, PA. Reapproved 2005.
      (2)  Conover, W.  1980.  Practical Nonparametric Statistics, 2[nd] Edition.  John Wiley & Sons, Inc., New York, NY.  493 pp.
      (3) Fletcher, J., J. Nellessen, and T. Pfleeger.  1994.  Literature review and evaluation of the EPA food-chain (Kenaga) Nomogram, an instrument for estimating pesticide residues on plants.  Environmental Toxicology and Chemistry 13(9):1383-1391.
      (4) Nellessen, J. and J. Fletcher.  1992.  UTAB: A computer database on residues of xenobiotic organic chemicals and heavy metals in plants. Journal of Chemical Information and Computer Sciences 32:144-148.
      (5) Organization for Economic Cooperation and Development (OECD), 1984.  Guidelines for testing of chemicals, Guideline 205, Avian Dietary Toxicity Test, Adopted April 1984.
      (6) U.S. Environmental Protection Agency, 1982.  Pesticide Assessment Guidelines Subdivision E, Hazard Evaluation: Wildlife and Aquatic Organisms.  Office of Pesticides and Toxic Substances, Washington, D.C.  EPA-540/9-82-024, October 1982.
      (7) U.S. Environmental Protection Agency, 1985.  Hazard Evaluation Division Standard Evaluation Procedure: Avian Dietary LC50 Test.  Office of Pesticides Programs, U.S. Environmental Protection Agency, Washington, D.C.  EPA-540/9-85-008, June 1985.


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on March 14, 2006

NOTICE OF ACTION TAKEN -- DOCKETS OST-95-940 & OST-98-3950

________________________________________________________________________
________________________________________________________

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

Applicant:  Cathay Pacific Airways Limtied			Date Filed:  January 11,
2005

Relief requested:

Docket OST-95-940:  Renew exemption from 49 U.S.C. § 41301 to conduct
scheduled foreign air transportation of (1) persons, property and mail
between Hong Kong and New York, NY, via the intermediate point
Vancouver, Canada; (2) property and mail between Hong Kong and the
coterminal points Anchorage, AK; Chicago, IL; and New York, NY via the
intermediate point Toronto, Canada.

Docket OST-98-3950:  Renew exemption from 49 U.S.C. § 41301 to conduct
scheduled foreign air transportation of persons, property and mail
between Hong Kong and San Francisco, CA.

If renewal, date and citation of last action:  February 3, 2004, in this
docket

Applicant representative:  William Evans<PHONE_NUMBER>

DOT Analyst:  Shelita A. Smith<PHONE_NUMBER>

Responsive pleadings:  None filed

DISPOSITION

Action:  Approved							Action date:  March 14, 2006

Effective dates of exemption authority granted:  March 14, 2006 –
March 14, 2007

Basis for approval (bilateral agreement/reciprocity):  October 12, 2002
Memorandum of Consultations between the

United States and Hong Kong

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

   X    Standard exemption conditions (attached)              X
Foreign air carrier permit   (Order 92-11-37)

Special conditions/Partial grant/Denial basis/Remarks:

Action taken by:  Paul L. Gretch, Director

		   Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) the applicant is qualified to perform the
proposed operations; (2) our action was consistent with Department
policy; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied

all requests in the referenced Docket.  We may amend, modify, or revoke
the authority granted in this Notice at any time without hearing at our
discretion.

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

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

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

Foreign Carrier Exemption Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

05/2004