[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Proposed Rules]
[Pages 18268-18269]
[FR Doc No: 2013-06949]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0193; Airspace Docket No. 13-ANM-9]

Proposed Establishment of Class E Airspace; Blue Mesa, CO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class E airspace at the Blue
Mesa VHF Omni-Directional Radio Range/Distance Measuring Equipment
(VOR/DME), Blue Mesa, CO to facilitate vectoring of Instrument Flight
Rules (IFR) aircraft under control of Denver and Albuquerque Air Route
Traffic Control Centers (ARTCCs). The FAA is proposing this action to
enhance the safety and management of aircraft operations within the
National Airspace System.

DATES: Comments must be received on or before May 10, 2013.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590;
telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2013-
0193; Airspace Docket No. 13-ANM-9, at the beginning of your comments.
You may also submit comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA 2013-0193 and Airspace Docket No. 13-ANM-9) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2013-0193 and Airspace Docket No. 13-ANM-9''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRM's

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking

documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA
98057.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) Part 71 by establishing Class E en route domestic
airspace extending upward from 1,200 feet above the surface at the Blue
Mesa VOR/DME, Blue Mesa, CO. This action would contain aircraft while
in IFR conditions under control of Denver and Albuquerque ARTCCs by
vectoring aircraft from en route airspace to terminal areas.
    Class E airspace designations are published in paragraph 6006, of
FAA Order 7400.9W, dated August 8, 2012, and effective September 15,
2012, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in this Order.
    The FAA has determined this proposed regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation; (1) Is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under DOT Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3) does not warrant preparation of a
regulatory evaluation as the anticipated impact is so minimal. Since
this is a routine matter that will only affect air traffic procedures
and air navigation, it is certified this proposed rule, when
promulgated, would not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority for the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would establish controlled airspace at the Blue Mesa VOR/DME,
Blue Mesa, CO.
    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9W, Airspace Designations and
Reporting Points, dated August 8, 2012, and effective September 15,
2012 is amended as follows:

Paragraph 6006 En Route Domestic Airspace Areas.

* * * * *

ANM CO E6 Blue Mesa, CO [New]

Blue Mesa VOR/DME, CO
    (Lat. 38[deg]27'08'' N., long. 107[deg]02'23'' W.)
    That airspace extending upward from 1,200 feet above the surface
within an area bounded by lat. 35[deg]39'30'' N., long.
107[deg]25'27'' W.; to lat. 36[deg]14'38'' N., long. 107[deg]40'25''
W.; to lat. 37[deg]34'25'' N., long. 108[deg]25'31'' W.; to lat.
37[deg]58'51'' N., long. 108[deg]22'29'' W.; to lat. 38[deg]45'39''
N., long. 107[deg]41'00'' W.; to lat. 39[deg]07'40'' N., long.
107[deg]13'47''W.; to lat. 39[deg]11'48'' N., long. 106[deg]29'16''
W.; to lat. 39[deg]02'30'' N., long. 105[deg]32'13'' W.; to lat.
36[deg]59'57''N., long. 104[deg]18'04'' W.; to lat. 36[deg]17'00''
N., long. 104[deg]14'00'' W.; to lat. 36[deg]12'53'' N., long.
104[deg]56'21'' W.; to lat. 36[deg]13'34''N., long. 105[deg]54'42''
W., thence to the point of beginning.

    Issued in Seattle, Washington, on March 18, 2013.
Clark Desing,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2013-06949 Filed 3-25-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 56 (Monday, March 23, 2020)]
[Notices]
[Pages 16402-16406]
[FR Doc No: 2020-06007]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88405; File No. SR-NYSEAMER-2020-16]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend the
NYSE American Options Fee Schedule

March 17, 2020.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on March 10, 2020, NYSE American LLC (``NYSE American'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.

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

    The Exchange proposes to amend the NYSE American Options Fee
Schedule (``Fee Schedule'') to raise the existing cap on the available
credit for certain Qualified Contingent Cross (``QCC'') transactions.
The Exchange proposes to implement the fee change effective March 10,
2020. The proposed change is available on the Exchange's website at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those 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 parts of such statements.

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

1. Purpose
    The purpose of this filing is to modify the existing cap on the
available credit to Floor Brokers that execute a specified number of
Qualified Contingent Cross (``QCC'') transactions.
    Currently, Floor Brokers earn a credit for executed QCC orders of
$0.07 per contact up to 300,000 contracts or $0.10 per contract above
300,000.\4\ QCC executions in which a Customer or Professional Customer
is on both sides of the QCC trade are not eligible for the Floor Broker
credit.\5\ The Exchange currently limits the maximum Floor Broker
credit to $375,000 per month per Floor Broker firm.\6\ The Exchange
proposes to increase this limit to $425,000. The Exchange believes the
proposed increase would continue to incent ATP Holders acting as Floor
Brokers to achieve the highest credit possible.
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    \4\ See Fee Schedule, Section I.F., QCC Fees & Credits, n. 1,
available here, https://www.nyse.com/publicdocs/nyse/markets/american-options/NYSE_American_Options_Fee_Schedule.pdf.
    \5\ See id., note 1.
    \6\ See id. (providing that ``[t]he maximum Floor Broker credit
paid shall not exceed $375,000 per month per Floor Broker firm'').
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    The Exchange proposes to implement the fee change effective March
10, 2020.
Background
    The Commission has repeatedly expressed its preference for
competition over regulatory intervention in determining prices,
products, and services in the securities markets. In Regulation NMS,
the Commission highlighted the importance of market forces in
determining prices and SRO revenues and, also, recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \7\
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    \7\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005) (S7-10-04) (``Reg NMS
Adopting Release'').
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    There are currently 16 registered options exchanges competing for
order flow. Based on publicly-available information, and excluding
index-based options, no single exchange has more than 16% of the market
share of executed volume of multiply-listed equity and ETF options
trades.\8\ Therefore, no exchange possesses significant pricing power
in the execution of multiply-listed equity & ETF options order flow.
More specifically, in the fourth quarter of 2019, the Exchange had less
than 10% market share of executed volume of multiply-listed equity &
ETF options trades.\9\
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    \8\ The OCC publishes options and futures volume in a variety of
formats, including daily and monthly volume by exchange, available
here: https://www.theocc.com/market-data/volume/default.jsp.
    \9\ Based on OCC data, see id., the Exchange's market share in
equity-based options was 9.82% for the month of January 2019 and
8.08% for the month of January 2020.
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    The Exchange believes that the ever-shifting market share among the
exchanges from month to month demonstrates that market participants can
shift order flow or discontinue or reduce use of certain categories of
products, in response to fee changes. Accordingly, competitive forces
constrain options exchange transaction fees.
    In response to this competitive environment, the Exchange has
established incentives, including the credits for QCC transactions
provided to ATP Holders acting as Floor Brokers, to encourage such ATP
Holders to execute QCCs on the Exchange.
    As noted above, the Exchange currently limits the maximum Floor
Broker rebate for QCCs to $375,000 per month per Floor Broker firm. The
Exchange proposes to increase this amount to $425,000.\10\ The Exchange
believes the proposed increase would continue to incent ATP Holders
acting as Floor Brokers to achieve the highest rebate possible.
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    \10\ See Fee Schedule, Section I.F., QCC Fees & Credits, n. 1,
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Proposed Rule Change
    Floor Brokers currently earn a rebate for executed QCC orders of
$0.07 per contact up to 300,000 contracts or $0.10 per contract above
300,000, provided that a Customer or Professional Customer
(collectively, ``Customer'') is not on both sides of the QCC trade.\11\
The Exchange currently limits the maximum Floor Broker rebate to
$375,000 per month per Floor Broker firm.\12\ The Exchange proposes to
increase this to $425,000.
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    \11\ See id.
    \12\ See id.
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    The Exchange's fees are constrained by intermarket competition, as
ATP Holders acting as Floor Brokers may direct their order flow to any
of the 16 options exchanges, including those with similar QCC rebate
programs and associated caps on same.\13\ Thus, ATP Holders have a
choice of where they direct their order flow. This proposed change--
which increases the maximum available credit--is designed to incent ATP
Holders acting as Floor Brokers to increase their QCC volumes on the
Exchange. The Exchange notes that all market participants stand to
benefit from increased volume, which promotes market depth, facilitates
tighter spreads and enhances price discovery, and may lead to a
corresponding increase in order flow from other market participants.
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    \13\ See, e.g., NASDAQ PHLX, Options 7 Pricing Schedule, Section
4. Multiply Listed Options Fees, QCC Rebate Schedule, available
here, http://nasdaqphlx.cchwallstreet.com/NASDAQPHLXTools/PlatformViewer.asp?selectednode=chp%5F1%5F1%5F3%5F1&manual=%2Fnasdaqomxphlx%2Fphlx%2Fphlx%2Dllcrules%2F (providing that ``[t]he maximum
QCC Rebate to be paid in a given month will not exceed $550,000'').
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    The Exchange cannot predict with certainty whether any ATP Holders
acting as Floor Brokers would avail themselves of this proposed fee
change. Assuming historical behavior can be predictive of future
behavior, the Exchange estimates that at least three firms may benefit
from this fee change.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\14\ in general, and furthers the
objectives of Sections

6(b)(4) and (5) of the Act,\15\ in particular, because it provides for
the equitable allocation of reasonable dues, fees, and other charges
among its members, issuers and other persons using its facilities and
does not unfairly discriminate between customers, issuers, brokers or
dealers.
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    \14\ 15 U.S.C. 78f(b).
    \15\ 15 U.S.C. 78f(b)(4) and (5).
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The Proposed Rule Change is Reasonable
    The Exchange operates in a highly competitive market. The
Commission has repeatedly expressed its preference for competition over
regulatory intervention in determining prices, products, and services
in the securities markets. In Regulation NMS, the Commission
highlighted the importance of market forces in determining prices and
SRO revenues and, also, recognized that current regulation of the
market system ``has been remarkably successful in promoting market
competition in its broader forms that are most important to investors
and listed companies.'' \16\
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    \16\ See Reg NMS Adopting Release, supra note 7, at 37499.
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    There are currently 16 registered options exchanges competing for
order flow. Based on publicly-available information, and excluding
index-based options, no single exchange has more than 16% of the market
share of executed volume of multiply-listed equity and ETF options
trades.\17\ Therefore, no exchange possesses significant pricing power
in the execution of multiply-listed equity & ETF options order flow.
More specifically, in the fourth quarter of 2019, the Exchange had less
than 10% market share of executed volume of multiply-listed equity &
ETF options trades.\18\
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    \17\ See supra note 8.
    \18\ Based on OCC data, see supra note 9, the Exchange's market
share in equity-based options was 9.82% for the month of January
2019 and 8.08% for the month of January 2020.
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    The Exchange believes that the ever-shifting market share among the
exchanges from month to month demonstrates that market participants can
shift order flow, or discontinue or reduce use of certain categories of
products, in response to fee changes. Accordingly, competitive forces
constrain options exchange transaction fees. Stated otherwise, changes
to exchange transaction fees and credits can have a direct effect on
the ability of an exchange to compete for order flow.
    The Exchange believes that the proposed modification to increase
the allowable cap on the Floor Broker credit for QCC transactions is
designed to incent ATP Holders acting as Floor Brokers to increase the
number QCC transactions executed on the Exchange. The proposal caps
fees on all similar (QCC) transactions, regardless of size and
similarly-situated ATP Holders can opt to try to achieve the modified
(and increased) credit. The proposal is designed to encourage ATP
Holders acting as Floor Brokers to execute all QCC transactions on
Exchange. To the extent that the proposed change attracts more QCC
trades to the Exchange Trading Floor, this increased order flow would
continue to make the Exchange a more competitive venue for, among other
things, order execution, which, in turn, promotes just and equitable
principles of trade and removes impediments to and perfects the
mechanism of a free and open market and a national market system.
    Finally, to the extent the proposed change continues to attract
greater volume and liquidity (to the Floor or otherwise), the Exchange
believes the proposed change would improve the Exchange's overall
competitiveness and strengthen its market quality for all market
participants. In the backdrop of the competitive environment in which
the Exchange operates, the proposed rule change is a reasonable attempt
by the Exchange to increase the depth of its market and improve its
market share relative to its competitors. The Exchange's fees are
constrained by intermarket competition, as OTP Holders may direct their
order flow to any of the 16 options exchanges, including those with
similar QCC credit programs and associated caps on same.\19\ Thus, ATP
Holders have a choice of where they direct their order flow--including
their QCC transactions. The proposed rule change is designed to incent
OTP Holders to direct liquidity to the Exchange--in particular QCC
transactions, thereby promoting market depth, price discovery and
improvement and enhancing order execution opportunities for market
participants.
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    \19\ See supra note 13 (regarding NASDAQ PHLX's $550,000 monthly
cap on QCC rebate).
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    The Exchange cannot predict with certainty whether any ATP Holders
acting as Floor Brokers would avail themselves of this proposed fee
change. Assuming historical behavior can be predictive of future
behavior, the Exchange estimates that at least three firms may benefit
from this fee change.
The Proposed Rule Change is an Equitable Allocation of Credits and Fees
    The Exchange believes the proposed rule change is an equitable
allocation of its fees and credits. The proposal is based on the amount
and type of business transacted on the Exchange and ATP Holders acting
as Floor Brokers can opt to avail themselves of the modified cap on QCC
transaction credits (i.e., by executing more QCC transactions) or not.
As the proposal is designed to encourage Floor Brokers to execute QCC
transactions on the Exchange, any resulting increase in order flow
would continue to make the Exchange a more competitive venue for order
execution. Thus, the Exchange believes the proposed rule change would
improve market quality for all market participants on the Exchange and,
as a consequence, attract more order flow to the Exchange thereby
improving market-wide quality and price discovery.
The Proposed Rule Change Is Not Unfairly Discriminatory
    The Exchange believes it is not unfairly discriminatory to modify
the maximum allowable credit on QCC transactions to Floor Brokers
because the proposed modification would be available to all similarly-
situated market participants on an equal and non-discriminatory basis.
    The proposal is based on the amount and type of business transacted
on the Exchange and ATP Holders acting as Floor Brokers are not
obligated to try to achieve the modified cap. Rather, the proposal is
designed encourage ATP Holders acting as Floor Brokers to utilize the
Exchange as a primary trading venue for QCC transactions (if they have
not done so previously) or increase volume sent to the Exchange. To the
extent that the proposed change attracts more QCC transactions to the
Exchange, this increased order flow would continue to make the Exchange
a more competitive venue for, among other things, order execution.
Thus, the Exchange believes the proposed rule change would improve
market quality for all market participants on the Exchange and, as a
consequence, attract more order flow to the Exchange thereby improving
market-wide quality and price discovery. The resulting increased volume
and liquidity would provide more trading opportunities and tighter
spreads to all market participants and thus 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, to protect investors and the public interest.
    Finally, the Exchange believes that it is subject to significant
competitive forces, as described below in the

Exchange's statement regarding the burden on competition.

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

    In accordance with Section 6(b)(8) of the Act, the Exchange does
not believe that the proposed rule change would impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. Instead, as discussed above, the Exchange believes
that the proposed changes would encourage the submission of additional
liquidity to a public exchange, thereby promoting market depth, price
discovery and transparency and enhancing order execution opportunities
for all market participants. As a result, the Exchange believes that
the proposed change furthers the Commission's goal in adopting
Regulation NMS of fostering integrated competition among orders, which
promotes ``more efficient pricing of individual stocks for all types of
orders, large and small.'' \20\
---------------------------------------------------------------------------

    \20\ See Reg NMS Adopting Release, supra note 7, at 37499.
---------------------------------------------------------------------------

    Intramarket Competition. The proposed change is designed to attract
additional order flow (particularly QCC trades) to the Exchange. The
Exchange believes that the proposed increased QCC Floor Broker credit
would incent market participants to direct their QCC volume to the
Exchange. Greater liquidity benefits all market participants on the
Exchange and increased Strategy Executions would increase opportunities
for execution of other trading interest. The proposed increased cap
would be available to all similarly-situated market participants that
execute QCC transactions, and, as such, the proposed change would not
impose a disparate burden on competition among market participants on
the Exchange.
    Intermarket Competition. The Exchange operates in a highly
competitive market in which market participants can readily favor one
of the 16 competing option exchanges if they deem fee levels at a
particular venue to be excessive. In such an environment, the Exchange
must continually adjust its fees to remain competitive with other
exchanges and to attract order flow to the Exchange. Based on publicly-
available information, and excluding index-based options, no single
exchange has more than 16% of the market share of executed volume of
multiply-listed equity and ETF options trades.\21\ Therefore, no
exchange possesses significant pricing power in the execution of
multiply-listed equity & ETF options order flow. More specifically, in
the fourth quarter of 2019, the Exchange had less than 10% market share
of executed volume of multiply-listed equity & ETF options trades.\22\
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    \21\ See supra note 8.
    \22\ Based on OCC data, supra note 9, the Exchange's market
share in equity-based options was 9.82% for the month of January
2019 and 8.08% for the month of January, 2020.
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    The Exchange believes that the proposed rule change reflects this
competitive environment because it modifies the Exchange's fees in a
manner designed to encourage ATP Holders to direct trading interest
(particularly QCC transactions) to the Exchange, to provide liquidity
and to attract order flow. To the extent that this purpose is achieved,
all the Exchange's market participants should benefit from the improved
market quality and increased opportunities for price improvement.
    The Exchange believes that the proposed change could promote
competition between the Exchange and other execution venues, including
those that currently offer similar QCC credits and caps thereon, by
encouraging additional orders to be sent to the Exchange for
execution.\23\ The Exchange also believes that the proposed change is
designed to provide the public and investors with a Fee Schedule that
is clear and consistent, thereby reducing burdens on the marketplace
and facilitating investor protection.
---------------------------------------------------------------------------

    \23\ See supra note 13.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \24\ of the Act and subparagraph (f)(2) of Rule
19b-4 \25\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
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    \24\ 15 U.S.C. 78s(b)(3)(A).
    \25\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \26\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \26\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File No. SR-NYSEAMER-2020-16 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 No. SR-NYSEAMER-2020-16. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish

to make available publicly. All submissions should refer to File No.
SR-NYSEAMER-2020-16, and should be submitted on or before April 13,
2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\27\
---------------------------------------------------------------------------

    \27\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-06007 Filed 3-20-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 224 (Wednesday, November 24, 2021)]
[Notices]
[Pages 67055-67056]
[FR Doc No: 2021-25604]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2021-0080; FRL-8795-05-OCSPP]

Pesticide Product Registration; Receipt of Applications for New
Uses (November 2021)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has received applications to register new uses for
pesticide products containing currently registered active ingredients.
Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), EPA is hereby providing notice of receipt and opportunity to
comment on these applications.

DATES: Comments must be received on or before December 27, 2021.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the File Symbol of interest as shown in the body of
this document, online at http://www.regulations.gov. Follow the online
instructions for submitting comments. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets/about-epa-dockets.
    Due to the public health concerns related to COVID-19, the EPA/DC
and Reading Room is closed to visitors with limited exceptions. The
staff continues to provide remote customer service via email, phone,
and webform. For the latest status information on the EPA/DC and docket
access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
Pollution Prevention Division (7511P), main telephone number: (703)
305-7090; email address: [email protected], Anita Pease,
Antimicrobials Division (7510P), main telephone number:<PHONE_NUMBER>;
email address: [email protected]. The mailing address for each
contact person is: Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001. As part of the mailing address, include the contact person's
name, division, and mail code. The division to contact is listed at the
end of each application summary.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a

copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public docket. Information
so marked will not be disclosed except in accordance with procedures
set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Registration Applications

    EPA has received applications to register new uses for pesticide
products containing currently registered active ingredients. Pursuant
to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA
is hereby providing notice of receipt and opportunity to comment on
these applications. Notice of receipt of these applications does not
imply a decision by the Agency on these applications.

Notice of Receipt--New Uses

    1. EPA Registration Number: 79814-5. Docket ID number: EPA-HQ-OPP-
2021-0516. Applicant: ICA TriNova, LLC. 1 Beavers Street, Suite B,
Newman, GA 30263. Active ingredient: Sodium Chlorite. Product type:
Post-Harvest Treatment, Fungicide, Bactericide, Antimicrobial. Proposed
use: Post-harvest application of gaseous chlorine dioxide to 14 new
crop groups: Crop group 1 (root and tuber vegetables), crop group 3
(bulb vegetables, bulbs), crop group 8 (fruiting vegetables), crop
group 9 (cucurbit vegetables), crop group 10 (citrus), crop group 11
(pome fruits), crop group 12 (stone fruits), crop group 13 (berries),
crop group 14 (tree nuts), crop group 16 (forage, fodder, and straw of
cereal grains), crop group 17 (grass forage, fodder, and hay), crop
group 18 (non-grass animal feeds), crop group 21 (edible fungi), crop
group 23 (tropical and subtropical fruits, medium and large, smooth
inedible peel). Contact: AD.
    2. EPA Registration Number: 84846-14. Docket ID number: EPA-HQ-OPP-
2021-0630. Applicant: FBSciences, Inc., 153 N Main St. Ste 100,
Collierville, TN 38017. Active ingredient: Complex Polymeric
Polyhydroxy Acids (CPPA). Product type: Fungicide and Insecticide.
Proposed use: In or on all food commodities. Contact: BPPD.
    Authority: 7 U.S.C. 136 et seq.

    Dated: November 15, 2021.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Program Support.
[FR Doc. 2021-25604 Filed 11-23-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 124 (Monday, June 29, 2015)]
[Notices]
[Pages 37003-37004]
[FR Doc No: 2015-15813]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2015-0001]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final Notice.

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

SUMMARY: New or modified Base (1-percent annual chance) Flood
Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA)
boundaries or zone designations, and/or regulatory floodways
(hereinafter referred to as flood hazard determinations) as shown on
the indicated Letter of Map Revision (LOMR) for each of the communities
listed in the table below are finalized. Each LOMR revises the Flood
Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance
Study (FIS) reports, currently in effect for the listed communities.
The flood hazard determinations modified by each LOMR will be used to
calculate flood insurance premium rates for new buildings and their
contents.

DATES: The effective date for each LOMR is indicated in the table
below.

ADDRESSES: Each LOMR is available for inspection at both the respective
Community Map Repository address listed in the table below and online
through the FEMA Map Service Center at www.msc.fema.gov.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final flood hazard determinations as shown in the
LOMRs for each community listed in the table below. Notice of these
modified flood hazard determinations has been published in newspapers
of local circulation and 90 days have elapsed since that publication.
The Deputy Associate Administrator for Mitigation has resolved any
appeals resulting from this notification.
    The modified flood hazard determinations are made pursuant to
section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4105, and are in accordance with the National Flood Insurance Act of
1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.
    For rating purposes, the currently effective community number is
shown and must be used for all new policies and renewals.
    The new or modified flood hazard information is the basis for the
floodplain management measures that the community is required either to
adopt or to show evidence of being already in effect in order to remain
qualified for participation in the National Flood Insurance Program
(NFIP).
    This new or modified flood hazard information, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities.
    This new or modified flood hazard determinations are used to meet
the floodplain management requirements of the NFIP and also are used to
calculate the appropriate flood insurance premium rates for new
buildings, and for the contents in those buildings. The changes in
flood hazard determinations are in accordance with 44 CFR 65.4.
    Interested lessees and owners of real property are encouraged to
review the final flood hazard information available at the address
cited below for each community or online through the FEMA Map Service
Center at www.msc.fema.gov.
    (Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: June 16, 2015.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Chief executive                                                                 Community
         State and county           Location and case No.  officer of community   Community map repository   Effective date of modification      No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alaska: Fairbanks-North Star        Fairbanks-North Star   The Honorable Luke    809 Pioneer Road,          April 15, 2015.................       025009
 Borough, (FEMA Docket No.: B-       Borough, (14-10-       Hopkins, Mayor,       Fairbanks, AK 99701.
 1465).                              1677P).                Fairbanks-North
                                                            Star Borough, 809
                                                            Pioneer Road,
                                                            Fairbanks, AK 99701.
Indiana: Lake, (FEMA Docket No.: B- City of Hammond (15-   The Honorable Thomas  5925 Calumet Avenue,       April 1, 2015..................       180134
 1465).                              05-0234P).             M. McDermott, Jr.,    Hammond, IN 46320.
                                                            Mayor, City of
                                                            Hammond, 5925
                                                            Calumet Avenue,
                                                            Hammond, IN 46320.
Iowa: Washington, (FEMA Docket      City of Kalona (14-07- The Honorable Ken     511 C Avenue, Kalona, IA   April 10, 2015.................       190601
 No.: B-1465).                       2178P).                Herington, Mayor,     52247.
                                                            City of Kalona, 511
                                                            C Avenue, Kalona,
                                                            IA 52247.
Kansas:
    Harvey, (FEMA Docket No.: B-    City of Sedgwick (14-  The Honorable Rodney  511 North Commercial,      April 10, 2015.................       200134
     1465).                          07-2492P).             Eggleston, Mayor,     Sedgwick, KS 67135.
                                                            City of Sedwick,
                                                            511 North
                                                            Commercial,
                                                            Sedgwick, KS 67135.
    Harvey, (FEMA Docket No.: B-    Unincorporated Areas   The Honorable Ron     800 North Main Street,     April 10, 2015.................       200585
     1465).                          of Harvey County (14-  Krehbiel, 3rd         Newton, KS 67114.
                                     07-2492P).             District
                                                            Commissioner,
                                                            Harvey County, 800
                                                            North Main Street,
                                                            Newton, KS 67114.
    Sedgwick., (FEMA Docket No.: B- Unincorporated Areas   The Honorable James   525 North Main #320,       April 10, 2015.................       200321
     1465).                          of Sedgwick County     Skelton, 5th          Wichita, KS 67203.
                                     (14-07-2492P).         District
                                                            Commissioner
                                                            Sedgwick County,
                                                            525 North Main
                                                            #320, Wichita, KS
                                                            67203.
    Wyandotte, (FEMA Docket No.: B- City of Kansas City    The Honorable Mark    701 North 7th Street,      April 21, 2015.................       200363
     1465).                          (14-07-2400P).         R. Holland, Mayor,    Suite 926, Kansas City,
                                                            City of Kansas        KS 66101.
                                                            City, 701 North 7th
                                                            Street, Suite 926,
                                                            Kansas City, KS
                                                            66101.
Washington:
    Whitman, (FEMA Docket No.: B-   Town of Oakesdale (14- The Honorable Dennis  105 North First Street,    April 3, 2015..................       530210
     1465).                          10-0693P).             Palmer, Mayor, Town   Oakesdale, WA 99158.
                                                            of Oakesdale, 105
                                                            North First Street,
                                                            Oakesdale, WA 99158.
    Washington: Whitman, (FEMA      Unincorporated Areas   The Honorable Art     400 North Main Street,     April 3, 2015..................       530205
     Docket No.: B-1465).            of Whitman County      Swannack, Whitman     Colfax, WA 99111.
                                     (14-10-0693P).         County District 1
                                                            Commissioner, 400
                                                            North Main Street,
                                                            Colfax, WA 99111.
Wisconsin:
    Dane, (FEMA Docket No.: B-      Unincorporated Areas   The Honorable Joe     210 Martin Luther King     April 16, 2015.................       550077
     1465).                          of Dane County (14-    Parisi, Executive,    Jr. Boulevard, Madison,
                                     05-6985P).             Dane County, 210      WI 53703.
                                                            Martin Luther King
                                                            Jr. Boulevard,
                                                            Madison, WI 53703.
Dane, (FEMA Docket No.: B-1465)...  Village of Cross       The Honorable Pat     3041 Creekside Way, Cross  April 16, 2015.................       550081
                                     Plains (14-05-6985P).  Andreoni,             Plains, WI 53528.
                                                            President, Village
                                                            Of Cross Plains,
                                                            3041 Creekside Way,
                                                            Cross Plains, WI
                                                            53528.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2015-15813 Filed 6-26-15; 8:45 am]
 BILLING CODE 9110-12-P


series.  The response to amyl alcohol did not fully recover within the
1-hour extended recovery period. Thus it appeared that the afferent
function depression was not due to receptor adaptation or insufficient
time for formaldehyde diffusion away from receptor sites.

870.1300

Other - Sensory Irritation

	Tsubone, H; Kawata, M.  (1991) Stimulation to the trigeminal afferent
nerve of the nose by formaldehyde, acrolein, and acetaldehyde gases.
Inhal Toxicol 3:211-222.

Open Literature

M Wistar Rat (6/group)

The afferent activity of the surgically isolated ethmoidal nerve (a
branch of the trigeminal nerve) during delivery of formaldehyde
(0.32–4.7 ppm) into the cannulated URT of rats at a flow rate of 200
mL/minutes for 22 seconds was recorded. Each exposure was repeated two
to four times at different concentrations.	The vapor concentration
associated with a 50% increase in nerve activity over the level of
control gas was calculated as approximately 1.8 ppm for formaldehyde.

Sensory Irritation

Formaldehyde, Lot No. 420807, 10 %a.i. (methanol free)

	MRID No. 43170601

Werley et al. (1994). Glutardehyde and Formaldehyde: Sensory Irritation
Study in Swiss-Webster Mice.  Union Carbide Lab Project No. 91U0123.

acceptable/non-guideline

Male Swiss-Webster ND4 mice (40-55 days old at start of study), 4
animals/dose

0, 0.34, 1.4, 6.9, 18.8, or 80.0 ppm (0, 0.42, 1.73, 8.55, 23.3, or 99.1
mg/m3), 30 min, head-only chambers	No treatment related mortality was
observed. Mice exposed to formaldehyde showed no treatment-related
clinical findings. All mice exposed to formaldehyde at 99.1mg/m3 showed
increased lacrimation and periocular wetness.  Slight reductions in body
weight were observed in some of the mice at the highest exposure doses
for formaldehyde.

Immunologic Sensitization

	Tarkowski, M. and Gorski, P. 1995. Increased IgE antiovalbumin level in
mice exposed to formaldehyde. Int. Arch. Allergy Immunol. 106:
422–424.

Open Literature

F Balb/c Mouse

Groups were exposed to 2 mg/m3 formaldehyde either 6 hours/day for 10
days, or to 6 hours/day once a week for 7 weeks.  Then all mice were
sensitized intranasally with ovalbumin.  	Following sensitization, titer
of serum anti-ovalbumin IgE antibodies were significantly higher in mice
exposed to formaldehyde 6 hours/day for 10 days, compared to mice
exposed 6 hours/week for 7 weeks or untreated. The authors concluded
that formaldehyde facilitates animal sensitization to ovalbumin through
histological changes occurring in the upper respiratory tract.

Immunologic Sensitization

	Riedel, F., et al. C.H.L. 1996. Formaldehyde Exposure Enhances
Sensitization in the Guinea Pig. Allergy 51: 94–99.

Open Literature

Guinea Pig (12/group)

Animals were exposed to formaldehyde concentrations of 0 (controls), 160
or 310 ug/m3 (0.13 and 0.25 ppm) for 5 days, followed by sensitization
to inhaled ovalbumin at days 5 and 19.  On day 26, a bronchial
provocation test with ovalbumin was performed, followed by repeated lung
function measurements to monitor bronchial obstruction.  Also, blood
samples were taken on day 0 (before formaldehyde exposure) and day 25
(before bronchial provocation test) and tested for anti-ovalbumin IgG1
antibodies.

	Following ovalbumin challenge, 10/12 animals exposed to 310 ug/m3
showed bronchial obstruction, compared with 3/12 control animals
(p<0.01); animals exposed to 160 ug/m3 were not significantly different
from controls. Anti-ovalbumin IgG antibodies were not detectable (<10
ELISA units or EU) in any animal at day 0, but were detectable in 0/12
controls, 3/12 animals exposed to 160 ug/m3, and 6/12 animals exposed to
310 ug/m3 at day 25.

Immunological

	Jakab, GJ.  (1992) Relationship between carbon black particulate-bound
formaldehyde, pulmonary antibacterial defenses, and alveolar macrophage
phagocytosis.  Inhal Toxicol 4:325-342.

Open Literature

White Female Swiss Mouse

Mice were exposed to formaldehyde after bacterial infection (Regimens A
and C), before bacterial infection (Regimen B), or before and after
infection (Regimen D).  In the first trial mice were exposed to 0, 1.0,
5.0, 10.0, or 15.0 ppm formaldehyde (0, 1.2, 6.2, 12.3, or 18.5 mg/m3).
The remaining mice were exposed to 0, 0.5, or 1.0 ppm formaldehyde (0,
6.2, or 1.2 mg/m3).  A 30-minute exposure to an infectious aerosol of S.
aureus deposited 2x105 staphylococci in the lungs. Bacterial loading was
determined in homogenized lung tissue by culturing diluted aliquots for
an estimate of bacteria present immediately after loading and 4 hours
later.

	Mice exposed to 15 ppm formaldehyde for the 4 hours following bacterial
infection (Regimen A) had approximately an 8% increase in bacteria,
indicating decreased host resistance (p=0.006).  Pre-infection exposure
to 0.5 or 1.0 ppm did not change bacterial loading 4 hours after
infection (Regimen B).  However, combining an 18-hour pre-infection
formaldehyde exposure with a 4-hour post-infection 1 ppm formaldehyde
exposure increased pulmonary bacterial loading by approximately 6.5%
(p<0.05).  Increased bacterial loading indicates that formaldehyde
exposure (Regimens A and D) reduced pulmonary bacterial resistance.
This is in apparent contradiction to the findings of increased host
resistance by Dean et al. (1984).  However, there are important
differences between the studies. The studies by Jakab (1992) are acute
studies examining effects at the respiratory tract where direct effects
are possible. Additionally, in some cases, the exposures were concurrent
with bacterial infection, and it is difficult to distinguish the
potential for formaldehyde effects directly on the mucociliary apparatus
as a barrier to infection.

Other

	Adams, D.O. et al. (1987) The Effect of Formaldehyde Exposure upon the
Mononuclear Phagocyte System of Mice. Toxicology and Applied
Pharmacology 88: 165-174.

Open Literature

Female Mouse

15 ppm (19 mg/m3), 6 hr/day, 5 days/week. 3 weeks	Exposure of mice to 19
mg/m3, 6 hr/day, 5 days/week for 3 weeks did not appreciably alter the
number of resident macrophages in the peritoneal cavit+y or that
elicited in response to MVE-2.

Dermal absorption

	Bartnik, F.G., Gloxhuber Chr., and Zimmermann V.  (1985)  Percutaneous
Absorption of Formaldehyde in Rats.  Toxicology Letters. v. 25. p. 167 -
172.

Open Literature

10 Male/4 Female Rat

[14C] Formaldehyde as a tracer and non-labeled formaldehyde were
incorporated into a cream and dermally applied at 200 mg to occluded and
nonocclusive dosing areas for 48 hours	Under non –occlusive
conditions, absorption of radiolabeled formaldehyde in the cosmetic
cream preparation was published as 6.1% in males and 9.2% in females.
Occlusive conditions reported absorption as 3.4% in males.

Other

Purity: Not Reported	Hester, et al. (2003) Formaldehyde-Induced Gene
Expression in F344 Rat Nasal Respiratory Epithelium.  Toxicology 187:
13-24.

Open Literature

8 F344 Male Rats

40 ul aliquots of water or formaldehyde (400 mM) were instillled into
nostrils using a pipette.  Twenty-four hours after treatment, nasal
epithelium was recovered from which total RNA was used to generate cDNA
probes.	Siginificance analysis of microarrays (SAM) hybridization data
revealed that 24 of the 1185 genes queried were significantly
up-regulated and 22 genes were significantly downregulated. The
identified genes with FA-induced change in expression belong to the
functional gene categories xenobiotic metabolism, cell cycle, apoptosis,
and DNA repair. These data suggest that multiple pathways are
dysregulated by formaldehyde exposure, including those involved in DNA
synthesis/repair and regulation of cell proliferation.

870.3100

Other

 Purity: 28.44%

	Vargova M, Wagnerova J, Liskova A, et al. (1993) Subacute
immunotoxicity study of formaldehyde in male rats. Drug Chem Toxicol
16:255-275.

Open Literature

Male Wistar Rat

Formaldehyde was administered by gavage at doses of 0, 20, 40, and 80
mg/kg/day for 4 weeks, 5 days/week, 1x/day	NOAEL: 40 mg/kg/day

LOAEL: 80 mg/kg/day for an increase in the incidence of hepatocelluar
vacuolization

870.3465

Other

Purity: 14-C Paraformaldehyde (97.3-99%),

 Unlabeled paraformaldehyde (95%)	Casanova, Mercedes, et al. (1994)
DNA-Protein Cross-links and Cell Replication at Specific Sites in the
Nose of F344 Rats Exposed Subchronically to Formaldehyde.  Fundamental
and Applied Toxicology 23:  525-536.

Open Literature

Rats inhalation (20 rats/group, 10 of which are preexposed (PE), 10 not
(N))

0.7, 2, 6, 10, or 15 ppm (0, 0.87, 2.5, 7.4, 12.4, or 18.6 mg/m3)
Preexposed animals whole-body exposed 6 hr/day, 11 weeks +4 days) On the
5th day of the 12th week, animals exposed once nose-only for 3 hours
H14-CHO using nominal concentrations DPX estimation: 6 ppm or 10 ppm
(7.4 or 12.4 mg/m3) On 5th day of 12th week, exposed to unlabeled
formaldehyde once nose-only for 3 hours using nominal concentration

	NOAEL: 2.5 mg/m3

LOAEL: 7.4 mg/m3

Visible lesions were only observed in animals exposed to 18.6 mg/m3 for
12 weeks. No formaldehyde-induced lesions were observed in the squamous
and olfactory regions of the nose. Rats exposed to 0.87 or 2.5 mg/m3
were indistinguishable from controls. At 7.4 mg/m3, lesions were
confined to multifocal epithelial hypertrophy, hyperplasia, and squamous
metaplasia of the lM, while the rest of the nose was unaffected. At
12.39 mg/m3, the most characteristic response was squamous metaplasia of
the transitional epithelial lining of the LM and medial
maxilloturbinate, and mild epithelial hyperplasia of the midseptum with
generally mild inflammatory cell infiltration.

At 18.6 mg/m3, formaldehyde-induced lesions were more severe than all
other exposure groups. Rats exposed for 12 weeks exhibited extensive
damage to the lining of the LM (high tumor site) with epithelial
erosions, transitional epithelial hyperplasia, squamous metaplasia,
intraluminal and mucosal infiltration by inflammatory cells, and
keratinizing epithelial plaques associated with subepithelial
inflammation. Animals exposed to 18.6 mg/m3 also exhibited thickening of
the periosteum of bones adjacent to severe epithelial damage, and
moderate degrees of edema and hyperemia of the lamina propria in these
regions. At 7.4 and 18.6 mg/m3, significantly (p<0.01) greater
incorporation of 14C into DNA occurred in the lateral meatus of
preexposed rats. Significantly (p<0.01) greater incorporation also
occurred in the medial and posterior meatuses of preexposed rats at 18.6
mg/m3.

APPENDIX C - Mutagenicity Profile for Formaldehyde and Paraformaldehyde

Table C1. Mutagenicity data for Formaldehyde

Guideline No./

Study Type	MRID No./

Reference Information/

Study Classification	Dosing and Animal Information	Results

Mutagenicity

870.5100

Bacterial reverse mutation test

	MRID 00132156

Jagannath, D. (1978) Mutagenicity Evaluation of Dantoin DMDMH-55 40-697
737543 in the Ames Salmonella/Microsome Plate Test: LBI Project No.
20838. Final rept. (Unpublished study received May 9, 1983 under
38906-5; prepared by Litton Bionetics, Inc., sub- mitted by Glyco, Inc.,
Greenwich, CT; CDL:250313-A)

Supplementary	0.001, 0.01, 0.10, 1.0, or 5.0 µL.

Salmonella tester strains TA-98,

TA-100, TA-1535

TA-I 537 and TA-1538. Saccharamyces indicator organisms, strain 04.

	Negative

870.5100

Bacterial reverse mutation test	MRID 00132157

Haworth, S.; Lawlor, T.; Burke, P.; et al. (1982). Salmonella/

Mammalian-microsome Preincubation Mutagenicity Assay (Ames Test): Test
Article 447:34-3: Study No. T1804.502. (Unpublished study received May
9, 1983 under 38906-5; prepared by Microbiological Assoc., submitted by
Glyco, Inc., Greenwich, CT; CDL:250313-B).

Acceptable	Test material (447:34-3, MA #T1804) tested at concentrations
of 3.0, 15.0, 75.0, 150, or 300 µg/plate.

Tester strains TA98, TA100, TA1535, TA1357, TA1358 ± metabolic
activation with araclor induced rat liver microsomes.

	Positive

Test article caused did cause a positive response (3.2-fold increase) on
tester strain TA98 without metabolic activation. A 1.9-fold increase was
observed on TA98 with metabolic activation. Also, increases of 2.2-fold
and 1.7-fold were observed on tester strain TA100 with and without
activation, respectively.

870.5100

Bacterial reverse mutation test

	O'DONOVAN, MR AND MEE,CD; FORMALDEHYDE IS A BACTERIAL MUTAGEN IN A
RANGE OF SALMONELLA AND ESCHERICHIA INDICATOR STRAINS; MUTAGENESIS
8(6):577-581, 1993

Open Literature

	0-200 ug/plate, pre-incubation exposure and standard plate-
incorporation assays

S. typhimurium Strains TA1535, TA1537, TA1538, TA98, TA100, and TA102
and E.coli Strains WP2(pKM101) and WP2uvrA (pKM101)

Purity: 37%	Pre-incubation exposure: positive for mutagenicity in TA98,
TA100, and TA102 and both E.coli strains.

Standard plate-incorporation assays:

Consistent mutagenicity was seen only for TA100 and WP2uvrA (pKM101).

No evidence of mutagenicity was seen for TA1535, TA1537, or TA1538 using
either method of exposure.

870.5100

Bacterial reverse mutation test

	Schmid, E., W. Goggelmann; and M. Bauchinger.  (1986)
Formaldehyde-induced Cytotoxic, Genotoxic, and Mutagenic Response in
Human Lymphocytes and Salmonella typhimurium.  Mutagenesis vol. 1 no. 6
p. 427-431.

Open Literature	The tests were carried out using the plate incorporation
assay and the pre-incubation method +/- S9 activation at doses of
0-1.5mM and 0-0.3mM formaldehyde, respectively.

The incubation mixture consisted of 0.5 ml phosphate buffer or S9 mix
and10 ul of an appropriate concentration of formaldehyde in water.

S. typhimurium Strain TA100 (0.1 ml bacterial suspension of about 10*8
cells were used in the pre-incubation method)

Purity: 37%	Plate Assay: weak positive response

Pre-Incubation Method: Without S9 mix, a1.6-fold increase of revertant
numbers over controls was induced.  With S9 mix, a 2.7-fold increase of
revertant numbers over controls was induced.

870.5100

Bacterial reverse mutation test	Temcharoen, P; Thilly, WG.  (1983) Toxic
and mutagenic effects of formaldehyde in Salmonella typhimurium. Mutat
Res 119:89-93.

Open Literature	The capacity of formaldehyde to induce forward mutations
to 8-azaguanine resistance in was examined. Formaldehyde concentrations
of 0.17 mM in the absence of S9 and 0.33 mM in the presence of S9.

S. typhimurium TM 677, a his+ revertant of TA 1535

Purity: 37%	Both toxicity and mutagenicity were obtained at formaldehyde
concentrations of 0.17 mM in the absence of S9 and 0.33 mM in the
presence of S9. The authors noted that, while the S9 might be enzyme
inactivating formaldehyde, the binding of formaldehyde to amino groups
of proteins in the S9 would effectively reduce the concentration of
formaldehyde entering the cells.

870.5200

Mouse visible specific locus test	Mouse Lymphoma L5178Y Cell TK Locus
Assay for Mutagenicity; A Study with Formaldehyde.  (DuPont, 7/28/80,
Haskell Laboratory Report No. 581-80).

Open Literature

	Doses of 0, 0.1, 0.5, 1, 5, 10 or20 ug/ml without activation only, four
trials

Mouse Lymphoma L5178Y Cell

Purity: 37%	An increase in mutation frequency was reported, especially
at 10 and 20 ug/ml.

870.5275

Sex-linked recessive lethal test in Drosophila melanogaster	Valencia,
R., J.M. Mason, and S. Zimmering. (1989) Chemical Mutagenesis Testing in
Drosophila. VI. Interlaboratory Comparison of Mutagenicity Tests After
Treatment of Larvae. Environmental and Molecular Mutagenesis, v. 14, p.
238-244.

Open Literature	Doses of 2,600 and 1,100 ppm

D. melanogaster (Canton-S M and Basc F)

Purity: 37%

	Positive

870.5375

In vitro mammalian chromosome aberration test

	MRID 00132168

Thilagar, A.; Kumaroo, P.; Pant, K. (1982) Cytogenicity Study: Chi- nese
Hamster Ovary (CHO) Cells in vitro: Test Article 447:34-1: Study No.
T1802.338. (Unpublished study received May 9, 1983 under 38906-5;
prepared by Microbiological Assoc., submitted by Glyco, Inc., Greenwich,
CT; CDL:250313-M)

Acceptable	Test material (447:34-1) was tested at concentrations of
28.43, 37.91, or 50.55 nL/mL.

Chinese hamster ovary cells (cell repository number CCL, 61)

Purity: 37% Formalin	Positive

Test article caused a significant dose-dependant increase in the
frequencies of chromosome aberrations in the Chinese Hamster Ovary
cells, both with and without S-9 activation.

870.5375

In Vitro mammalian chromosome aberration test	Natarajan, A.T. et al.
(1983) Evaluation of the mutagenicity of formaldehyde in mammalian
cytogenics assays in vivo and vitro.  Mutation Research 122: 355-360.

Open Literature	In Vitro

CHO cells exposed to 0, 0.003, 0.006, 0.012, or 0.024 uL/mL
paraformaldehyde

In Vivo Mouse

0.4 mL paraformaldehyde injected intraperitoneally to achieve doses of
0, 6.25, 12.50, or 25.00 mg/kg

 	In Vitro: Positive

Frequencies of chromosomal aberrations and SCEs increased with
increasing dose. All classes of aberration, i.e. gaps, breaks, and
exchanges, were induced by formaldehyde. All the aberrations were
chromatid-type, indicating that formaldehyde acts as an S-dependent
agent. The addition of mammalian metabolic activation system reduced the
frequencies of formaldehyde-induced aberrations at all doses.
Similarly, there was also a reduction in the frequencies of SCEs induced
by formaldehyde, if the treatment was done in the presence of S9.

In Vivo: Negative

None of the concentrations used increased the frequencies of micronuclei
over the control level.  Formaldehyde was not effective in inducing
chromosomal aberrations.

870.5380

Mammalian spermatogonial chromosomal aberration test
Fontignie-Houbrechts, N. (1981) Genetic Effects of Formaldehyde in the
Mouse.  Mutation Research, v. 88, p. 109-114.

Open Literature

	Mice received an i.p. injection of 50 mg/kg formaldehyde

M Q Strain Mouse (200 spermatocytes/ animal)

Purity: 35%	Negative

No chromosomal lesions were revealed

870.5450

Rodent dominant lethal assay	Fontignie-Houbrechts, N. (1981) Genetic
Effects of Formaldehyde in the Mouse.  Mutation Research, v. 88, p.
109-114. (as cited in Ma and Harris)

Open Literature	Mice received an i.p. injection of 50 mg/kg formaldehyde
and 10 males were caged with 2 virgin females each for one week.  The
females were renewed each week during 7 weeks.

M Q Strain Mouse

Purity: 35%	Embryonic death or pre-post implantation death at 1 and 3
week periods

870.5450

Rodent dominant lethal assay	Odeigah, P.G.C.  (1997) “Sperm Head
Abnormalities and Dominant Lethal Effects of Formaldehyde in Albino
Rats.” Mutation Research 389: 141-148.

Open Literature   	Five daily interperitonial injections of 0.125,
0.250, and 0.6 mg/kg formaldehyde.  Males   were caged with 2 untreated
virgin females which were replaced weekly for 3 consecutive weeks giving
a total of 24 females for the periods 1-7, 8-14, and 15-21 days
post-injection, respectively.  All females were sacrificed 13 days after
the mid-week of their caging.  At autopsy, each female was scored for
total implants.

Albino Rats (12 M/group)

Purity: 37% solution (stabilized with 10% methanol)	Positive

The frequency of dominant lethal mutations in female rats sired by males
exposed to formaldehyde was significantly higher than the control group.

870. 5550

Unscheduled DNA synthesis in mammalian cells in culture

	MRID 00132169

Thilagar, A.; Pant, K. (1982) Unscheduled DNA Synthesis in Rat
Hepatocytes: Test Article 447:34-1: Study No. T1802.380002. (Un-
published study received May 9, 1983 under 38906-5; prepared by
Microbiological Assoc., submitted by Glyco, Inc., Greenwich, CT;
CDL:250313-N)

Acceptable	Test material (447:34-1) was tested at concentrations of
0.0005, 0.001, 0.005, 0.01, 0.02, or 0.04 µL/mL.

Primary rat liver hepatocytes – Sprague-Dawley rats, 2.5 x 105
HPC/plate

Purity: 37% a.i.	Negative

The test article did not cause a significant increase in UDS in rat
hepatocytes.

870.5900

In Vitro Sister Chromatid Exchange Assay	A. Basler, W. v. d. Hude, and
M. Scheutwinkel-Reich (1985) “Formaldehyde-Induced Sister Chromatid
Exchanges in vitro and the Influence of the Exogenous Metabolizing
Systems S9 Mix and Primary Rat Hepatocytes.” Arch Toxicol 58: 10-13.

Open Literature

	The test compound was added to cell cultures 18 hours after seeding 5 x
105 cells per 25 cm2 flask.  The exposure time was 1, 2, 3, or 28 hours.
In the experiments with short-term exposure (1-3 hours), the medium was
removed after this treatment. The cells were restored in medium
supplemented with 5-bromo-2-deoxyuridine (BrdU).  The cells were
cultured in the presence of BrdU (10-5 M) for 28 h, with colcemide (0.1
µg/ml) for the last 4 h.  In the experiments with long-term exposure,
the cells were cultured in the presence of BrdU and the test compounds
for 28 hr. In tests with S9 mix, the cells were incubated with 0.5 ml S9
mix per 25 cm2 flask and 0.033, 0.067, 0.13, 0.2, 0.27, 0.4, and 0.54 mM
formaldehyde for 3 h, followed by incubation for 28 hr in the presence
of BrdU as described above. In tests with primary rat hepatocytes, 106
viable hepatocytes were added to the monolayer. After 2 hr, the
nonattached hepatocytes were sucked off and the different concentrations
of formaldehyde were added. The medium was complemented with BrdU and
incubated for 28 h as above. S9 fraction was prepared from Aroclor
1254-induced male Wistar rats.

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demonstrated that the reduction was not due to an unspecific binding of
formaldehyde to macromolecules of the added S9 mix. The decrease in
genotoxic effects, due to rapid metabolisation of formaldehyde in vitro
and un vivo, explains the differences between results obtained in the in
vitro experiments – performed without metabolizing systems – and in
vivo results.

870.5915

In Vivo Sister Chromatid Exchange Assay	Kligerman,AD; Phelps, MC;
Erexson, GL.  (1984) Cytogenetic analysis of lymphocytes from rats
following formaldehyde inhalation.  Toxicol Lett 21:241-246.

Open Literature	Rats were exposed to 0.5, 6, or 15 ppm (0.6, 7.4, 18.5
mg/m3) formaldehyde by inhalation for 6 hours/day for 5 days.   Blood
was obtained by cardiac puncture within 1 h of the last exposure and
cultured with BrdU for sister chromatid exchange (SCE) analysis.

M and F Fischer F-344 Rat

Purity: 95% a.i.? (Not reported in study) 	There were no increases in
either SCE or chromosome aberrations at any dose level.

In vitro human lymphoblasts	Craft, T.R., E. Bermudez, and T.R. Skopek
(1987) Formaldehyde mutagenesis and formation of DNA-protein crosslinks
in human lymphoblasts in vitro.  Mutation Research 176:  147-155.

Open Literature	0, 15, 30, 50, 125, or 150uM

Human Lymphoblasts (4x 10^5 cells/mL)

Formaldehyde (37% w/w 10-15% methanol)	Positive

Concentrations ≥ 30 uM yielded statistically significant responses
(p<0.05).

Multiple treatments of 15, 30, and 50 uM also resulted in increases in
mutant fractions. Lymphoblasts exposed repeatedly to these lower
concentrations accumulate formaldehyde-induced mutations, but at a lower
rate than if a single 150uM treatment was given at one time.

In vitro human lymphoblasts	Liber, HL; Benforado, K; Crosby, RM; et al.
(1989) Formaldehyde-induced and spontaneous alterations in human hprt
DNA sequence and mRNA expression.  Mutat Res 226:31-37.

Open Literature

	Liber et al. (1989) followed up the findings of Crosby et al. (1988) by
performing Northern blot and sequence analysis on the 16 induced and 10
spontaneous mutants not showing deletions.

Human Lymphoblasts

Purity: 37%	Northern blot analysis showed that the point mutations fall
into four categories; normal size and amount of RNA, normal size but
reduced amounts of RNA, reduced size and amounts of RNA, and no RNA.
Sequence analysis of recombinant DNAs from HRPT mRNA in compound-induced
mutants showed a preferential AT to CG transversion at a single site,
with other changes represented to a lesser degree.

Other	Graves, RJ; Trueman, P; Jones, S; Green, T.  (1996) DNA sequence
analysis of methylene chloride-induced HPRT mutations in Chinese hamster
ovary cells: Comparison with the mutation spectrum obtained for
1,2-dibromoethane and formaldehyde.  Mutagenesis 11:229-233.

Open Literature	DNA sequence analysis of formaldehyde-induced HRPT
mutations

Chinese Hamster Ovary Cell

Purity: 40%	Single-base pair transversions, including three AT to TA at
position 548 of exon 8, one GC to TA, and two AT to CG transversions at
other sites.

Other	Blackburn, GR; Dooley, J, III; Schreiner, CA; et al.  (1991)
Specific identification of formaldehyde-mediated mutagenicity using the
mouse lymphoma L5178Y TK positive negative assay supplemented with
formaldehyde dehydrogenase.  In Vitro Toxicology 4:121-132.

Open Literature	Forward mutation assay

Mouse lymphoma L5178Y tk+/- cells

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 PAGE

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`


[Federal Register Volume 76, Number 93 (Friday, May 13, 2011)]
[Proposed Rules]
[Pages 27956-27958]
[FR Doc No: 2011-11882]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0453; Directorate Identifier 2008-SW-16-AD]
RIN 2120-AA64

Airworthiness Directives; Eurocopter Deutschland Model EC135
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Eurocopter Deutschland (ECD) Model EC135 helicopters. This proposed AD
results from a mandatory continuing airworthiness information (MCAI) AD
issued by the aviation authority of the Federal Republic of Germany,
with which we have a bilateral agreement, to identify and correct an
unsafe condition. The MCAI AD states that in the past, the FADEC FAIL
caution light illuminated on a few EC135 T1 helicopters. They state
that this was caused by a discrepancy in the parameters which were
generated within the fuel main metering unit and transmitted to the
FADEC. This discrepancy led to the display of the FADEC FAIL caution
light and ``freezing'' of the fuel main metering valve at its position
resulting in loss of the automatic engine control in the affected
system. With the EASA AD, a synchronization procedure for pilots, which
was already used in the past, is being re-introduced, which prevents
the parameter discrepancy arising and thus sustains the automatic
engine control.
    The proposed AD actions are intended to prevent failure of the
FADEC to automatically meter fuel, indicated by a FADEC FAIL cockpit
caution light, and subsequent loss of control of the helicopter.

DATES: We must receive comments on this proposed AD by June 13, 2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    You may get the service information identified in this proposed AD
from American Eurocopter Corporation, 2701 Forum Drive, Grand Prairie,
Texas 75053-4005, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.
    Examining the AD Docket: You may examine the AD docket on the
Internet at http://www.regulations.gov, or in person at the Docket
Operations office between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this proposed AD, the
economic evaluation, any comments received, and other information. The
street address for the Docket Operations office (telephone (800) 647-
5527) is in the ADDRESSES section. Comments will be available in the AD
docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Eric Haight, Aviation Safety Engineer,
FAA, Rotorcraft Directorate, Regulations and Guidance Group, Fort
Worth, Texas 76137, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2011-0453;
Directorate Identifier 2008-SW-16-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    Luftfahrt-Bundesamt, which is the aviation authority for the
Federal Republic of Germany, has issued AD No. 2002-333, dated
September 16, 2002, to correct an unsafe condition for this German-
certificated product. The MCAI AD states that in the past, the FADEC
FAIL caution light illuminated on a few EC135 T1 helicopters. They
state that this was caused by a discrepancy in the parameters which
were generated within the fuel main metering unit and transmitted to
the FADEC. This discrepancy led to the display of the FADEC FAIL
caution light and ``freezing'' of the fuel main metering valve at its
position resulting in loss of the automatic engine control in the
affected system. Despite measures undertaken by Turbomeca to eliminate
this problem (software improvements TU19C, TU23C and TU45C), additional
FADEC FAIL cases have occurred on EC 135 T1 helicopters for which no
explanation has been found. Therefore, a discrepancy in the parameters
similar to those in the past cannot be ruled out. With this proposed
AD, a synchronization procedure for pilots, which was already used in
the past, is being re-introduced, which prevents the parameter
discrepancy arising and thus sustains the automatic engine control. To
date, there is no terminating action to this required manual pilot
synchronization procedure.
    You may obtain further information by examining the MCAI AD and the
service information in the AD docket.

Related Service Information

    ECD has issued Alert Service Bulletin No. EC135-71A-024, dated
August 6, 2002 (ASB). The ASB contains copies of special information to
be inserted into the Rotorcraft Flight Manual (RFM) for synchronizing
fuel control components for sustaining automatic engine control. The
ASB specifies making copies of the RFM pages contained in the ASB,
cutting them out, and filing them in the RFM. The actions described in
the MCAI AD are intended to correct the same unsafe condition as that
identified in this service information.

FAA's Determination and Requirements of This Proposed AD

    This model helicopter has been approved by the aviation authority
of the Federal Republic of Germany and is approved for operation in the
United States. Pursuant to our bilateral

agreement with that State of Design Authority, we have been notified of
the unsafe condition described in the MCAI AD and service information.
We are proposing this AD because we evaluated all pertinent information
and determined an unsafe condition exists and is likely to exist or
develop on other products of the same type design.

Differences Between This AD and the MCAI AD

    We use a 50-hour TIS compliance time rather than before further
flight as used in the MCAI AD. Also, the MCAI AD states to follow the
ASB and insert pages into the RFM. We did not follow the ASB, which
requires the RFM information to be filed in the Section 4, Normal
Procedures, of the RFM. To make compliance with the information
mandatory, we are requiring that it be inserted into the Section 2,
Limitations Section of the RFM.

Costs of Compliance

    We estimate that this proposed AD would affect about 20 helicopters
of U.S. registry. We also estimate that it would take about \1/2\ work-
hour to copy and insert the synchronization procedure into the RFM. The
average labor rate is $85 per hour. We estimate the cost of the
proposed AD on U.S. operators to be $850.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Eurocopter Deutschland: Docket No. FAA-2011-0453; Directorate
Identifier 2008-SW-16-AD.

Comments Due Date

    (a) We must receive comments by June 13, 2011.

Other Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Model EC135 helicopters with Turbomeca
Arrius 2B or 2B1 engines installed, certificated in any category.

Reason

    (d) The mandatory continuing airworthiness information (MCAI) AD
states that in the past, the FADEC FAIL caution light illuminated on
a few EC135 T1 helicopters. They state that this was caused by a
discrepancy in the parameters which were generated within the fuel
main metering unit and transmitted to the FADEC. This discrepancy
led to the display of the FADEC FAIL caution light and ``freezing''
of the fuel main metering valve at its position resulting in loss of
the automatic engine control in the affected system. A discrepancy
in the parameters similar to those in the past cannot be ruled out.
With this AD, a synchronization procedure for pilots is being re-
introduced, which prevents the parameter discrepancy arising and
thus sustains the automatic engine control.

Actions and Compliance

    (e) Within 50 hours time-in-service (TIS), unless already done,
either insert the following procedure by making pen and ink changes
to the Rotorcraft Flight Manual (RFM) or by inserting a copy of this
AD into the Limitations Section of the RFM.

    ``SPECIAL INFORMATION FOR OEI/AUTOROTATION TRAINING AND
APPROACH/LANDING PREPARATION
    In order to prevent a malfunction, which could lead to a FADEC
FAIL indication, the following procedure is mandatory:
    The procedure shown below must be performed while in a steady
flight condition and at a safe altitude:

--Before initiation of every approach (with or without landing)
--During training of OEI or Autorotation before every switch-over to
IDLE

    CAUTION: DURING THE RESET PROCEDURE DESCRIBED IN THE FOLLOWING,
NO INPUTS ARE TO BE MADE TO THE COLLECTIVE LEVER OR TO THE TWIST
GRIP FOR MANUAL ENGINE CONTROL, SINCE THIS CAN LEAD TO AN
INEFFECTIVE SYNCHRONIZATION.
    The reset procedure is identical for each of two systems and is
to be applied for both engines, one after the other.
    Procedure
    1. ENG MODE SEL switch--Set from NORM TO MAN
    After illumination of the ENG MANUAL caution:
    2. ENG MODE SEL switch--Set from MAN to NORM: ENG MANUAL caution
must go off
    Repeat procedure for second engine.''

Differences Between This FAA AD and the MCAI AD

    (f) We use a 50-hour TIS compliance time rather than before
further flight. Also, the MCAI AD states to follow the ASB and
insert pages into the RFM. We did not follow the ASB, which requires
the RFM information to be filed in the Section 4, Normal Procedures,
of the RFM. To make compliance with the information mandatory, we
are requiring that it be inserted into the Section 2, Limitations
Section of the RFM.

Other Information

    (g) Alternative Methods of Compliance (AMOCs): The Manager,
Safety Management Group, Rotorcraft Directorate, FAA, ATTN: Eric
Haight, Aviation Safety Engineer, Regulations and Guidance Group,
2601 Meacham Blvd., Fort Worth, Texas 76137, telephone (817) 222-
5204, fax<PHONE_NUMBER>, has the authority to approve AMOCs, if
requested, for this AD using the procedures found in 14 CFR 39.19.

Related Information

    (h) MCAI AD 2002-333, dated September 16, 2002, contains related
information.

Air Transport Association of America (ATA) Tracking Code

    (i) The ATA Code is 7600: Engine Controls.

    Issued in Fort Worth, Texas on April 28, 2011.
Scott A. Horn,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2011-11882 Filed 5-12-11; 8:45 am]
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