[Federal Register Volume 81, Number 188 (Wednesday, September 28, 2016)]
[Notices]
[Pages 66702-66705]
[FR Doc No: 2016-23323]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78908; File No. SR-NASDAQ-2016-111]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing of Proposed Rule Change To Amend Nasdaq Rules 4702 and
4703

September 22, 2016.
    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 September 13, 2016, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Nasdaq Rules 4702, Order Types, and
4703, Order Attributes, to change the way in which Post Only Orders
interact with resting Non-Display orders and preventing the execution
of midpoint pegged orders during a crossed market.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The 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 offers various Order Types \3\ and Order Attributes
\4\ to help members trade effectively on behalf of investors and
themselves. This proposal would modify the manner in which two of those
order types, Non-Display and

Post Only, interact within Nasdaq's trading system.
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    \3\ See Exchange Rule 4702. The Exchange also proposes a minor
technical correction to add the word ``price'' after the word
``displayed'' in the second line of the second paragraph of Rule
4702(b)(4)(B).
    \4\ See Exchange Rule 4703.
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    Nasdaq's Non-Display Orders, described in Rule 4702(b)(3), help
members minimize market impact when trading in larger-than-average
size. For example, institutions often use Non-Display Orders that use
pegging at the midpoint (Midpoint Peg Order) \5\ of the National Best
Bid and Offer (NBBO) to reduce market impact because a midpoint
execution does not indicate a price movement direction, as opposed to
buying at the offer or selling at the bid (sometimes referred to as
``crossing the spread'') which may publicly indicate the direction of
the stock price.
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    \5\ See Exchange Rule 4702(b)(3)(C).
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    The Exchange also offers Post Only Orders, described in Rule
4702(b)(4), which members, often market makers, use to rest liquidity
on Nasdaq's Order Book. Resting displayed liquidity is essential to
price formation and order interaction, two indicators of healthy and
orderly markets. Nasdaq introduced Post Only Orders \6\ to enable and
encourage this valuable behavior. A Post Only buy (sell) order entered
at a price that is at least $0.01 higher (lower) than a resting sell
(buy) order will execute, thereby providing price improvement that
exceeds the foregone rebate for liquidity provision and fee for
removing liquidity. If a Post Only buy (sell) order is entered at a
price equal to a resting sell (buy) order, the buy (sell) order is
repriced one minimum price increment (MPV), generally $0.01 \7\ lower
(higher) than the resting sell (buy) order's price.
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    \6\ See Post Only order Factsheet: http://www.nasdaqtrader.com/content/ProductsServices/Trading/postonly_factsheet.pdf.
    \7\ Securities priced at or above $1 are quoted in $0.01
increments, below $1, they can be quoted in $0.0001 increments. Post
Only behavior is slightly different below $1 because the fees and
economics involved in the execution are distinct from those above
$1. See Exchange Rule 4702(b)(4)(A). Fees for securities priced at
or above $1 are assessed on a per-share basis; fees for securities
priced below $1 are assessed as a percentage of transaction value.
Compare Rules 7018 (a) and (b). In both cases, the Exchange system
is programmed to analyze the price improvement offered and to
execute only where permitted under its rules.
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    This repricing function, sometimes referred to as ``price-
sliding,'' often occurs when a liquidity provider seeking to tighten
the bid/offer spread on Nasdaq encounters a Non-Display Order on the
opposite side of market from the Post Only Order. When this occurs, the
displayed spread on Nasdaq may become wider than on competing exchanges
therefore reducing market quality and the likelihood of execution on
Nasdaq. In addition, the member entering the Post Only Order learns
through the repricing action both that there is a Non-Display Order
resting on the book and also the price at which the Non-Display Order
is resting. The Exchange believes that this interaction is inefficient
and detrimental to investors, to members, and to the market.
    Accordingly, the Exchange proposes two changes to the manner in
which certain Post Only Orders respond to certain Non-Display Orders
resting on the opposite side of the market. In all other instances,
there will be no change. For example, Post-Only Orders will continue to
execute against resting Non-Display Orders provided the execution
results in minimum price improvement of $0.01 for the member entering
the Post Only Order, as they do today.
    First, a Post-Only Order that is entered with a price equal to a
resting Non-Display Order will be posted at its limit price (or its
adjusted price if applicable),\8\ rather than being re-priced as it is
today. This allows the Post Only Order to lock the resting Non-Display
Order.\9\ Both the displayed Post Only order and the resting Non-
Display order will remain available for execution at the locking price.
In this way, neither order is disadvantaged; the Exchange Bid/Offer
spread is tightened; and no signal is sent to the member that entered
the Post Only Order. In this scenario, efficacy is maintained or
enhanced for both the Post Only Order user and the Non-Display Order
user compared to today. For example, under the current rules if a
Participant entered a Post-Only Order to buy at $11.02, the Best Offer
\10\ was $11.04, and there was a Non-Displayed Order on the Nasdaq Book
to sell at $11.02, the Post-Only Order would be ranked and displayed at
$11.01. Using the above scenario, the Exchange is proposing to instead
rank and display the Post-Only Order to buy at its limit price of
$11.02.
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    \8\ If a Post-Only Order is received at a price that would lock
or cross a Protected Quotations [sic], its price will be adjusted in
the same manner as a Price to Comply order (if it is not
Attributable) or a Price to Display Order (if it is Attributable).
See Rules 4702(b)(1) and 4702(b)(4)(A).
    \9\ The Exchange believes that this condition is consistent with
the Regulation NMS prohibition on locked and crossed markets because
the Exchange will not be displaying a locked market.
    \10\ The term ``Best Offer'' is defined in Exchange Rule
4701(j).
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    Second, the Exchange also proposes to modify processing when a Post
Only Order interacts with a Non-Display Order that is a Midpoint Peg
Order. Specifically, when a Post Only buy (sell) order is priced higher
(lower) than a resting Midpoint Peg Order but where the difference is
less than $0.01, the Post Only Order will nonetheless be posted at its
limit price. This proposal benefits investors and members because it
results in a tighter Bid/Offer spread. Moreover, because the Post Only
order is not re-priced relative to the resting Midpoint Peg order, as
it is today, there is no information leakage. Additionally, the member
entering the Midpoint Peg Order benefits because the new midpoint based
on the new NBBO would now be a better price for the seller. Midpoint
Peg orders are either cancelled or re-adjusted based on NBBO changes
depending on the protocol used by the member to enter the Midpoint Peg
Order.\11\ For example, under the current rules if the NBBO is $10.11 x
$10.16 and a Participant enters a Midpoint Peg Order (which, as stated
above, is Non-Displayed) to buy 200 shares with a limit price of
$10.15, the Midpoint Peg Order would post to the book at $10.135. If
thereafter a Post-Only Order to sell 200 shares at $10.13 is entered,
the Post-Only Order would post and display at $10.14. Under the
proposed change and using the example above, the incoming Post-Only
Order to sell 200 shares at $10.13 would post and display at $10.13 and
the Midpoint Peg Order would either be adjusted to the new midpoint
($10.125 [sic]) based on the change in the NBBO due to the Post-Only
Order being displayed (the NBBO is now $10.11 x $10.14 [sic] due to the
Post-Only Order posting and displaying at $10.14 [sic]) or cancelled,
depending on the protocol used to enter the Midpoint Peg order.
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    \11\ See Exchange Rule 4703(d).
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    In addition, the Exchange proposes to discontinue executing
midpoint pegged orders when the NBBO is crossed. Today, the Exchange
executes midpoint pegged orders when the NBBO is locked by executing at
the locking price and when the NBBO is crossed by executing at the
midpoint of the crossed price. Based upon feedback from members and the
practice of other exchanges,\12\ the Exchange has determined that its
current practice of executing midpoint pegged orders during such
crossed markets produces sub-optimal execution prices for members and
investors. The midpoint of a crossed market is not a clear and accurate
indication of a valid price, nor is it indicative of a fair and orderly
market. The better result is to simply not execute midpoint orders
during crossed markets. To accomplish this, the Exchange will program
the trading system to respond to the creation of a crossed NBBO by
cancelling existing midpoint pegged orders and rejecting the entry of
new

midpoint pegged orders.\13\ After such order cancellation or rejection,
members can resubmit their orders at their discretion without
limitation. Accordingly, the Exchange proposes to modify the rule
language describing the processing of Orders with the midpoint pegging
attribute as well as Midpoint Peg Post Only Orders, which are described
in Rules 4703(d) and 4702(b)(5).
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    \12\ See, e.g., BATS Rule 11.9(c)(9) (no midpoint execution
during crossed market); NYSE Arca Rule 7.31(d)(4) (no midpoint
execution when the market is locked or crossed).
    \13\ Similarly, in the absence of an NBBO, the Exchange will
either reject the entry of new Midpoint Peg Post Only Orders or
cancel any such existing orders before they execute. The Exchange is
proposing to add words ``cancelled or'' prior to ``rejected'' in
Rule 4702(b)(5)(A).
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    As set forth below, the Exchange believes the proposed changes will
benefit investors and members by addressing certain market
inefficiencies that exist on Nasdaq, and by improving Nasdaq's
competitive position against other exchanges that already offer similar
processing of resting and non-displayed orders.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\14\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\15\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest in several ways.
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    \14\ 15 U.S.C. 78f(b).
    \15\ 15 U.S.C. 78f(b)(5).
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    First, the proposed changes will benefit investors and members by
tightening bid/offer spreads, thereby enhancing execution quality on
the Exchange. Second, members entering Post Only Orders will be able to
execute liquidity-providing strategies more efficiently. Third, the
proposed changes will reduce the signaling created today by the
interaction of Post Only and Non-Display Order, and thereby minimize
the market impact of larger orders. Fourth, the cancellation or
rejection of midpoint pegged orders when the NBBO is crossed will avoid
mispriced executions and result in higher overall execution quality for
members.
    The Exchange believes the proposed changes have no detrimental
impact on any member or class of members, or on users of the Post Only
or Non-Display Order types or on users of other order types offered by
the Exchange. First, the use of Exchange Order types and attributes is
voluntary, in that no member is required to use any specific Order type
or attribute or even to use any Exchange Order type or attribute or any
Exchange functionality at all. If an Exchange member believes for any
reason that the proposed rule change will be detrimental, that
perceived detriment can be avoided by choosing not to enter or interact
with the Order types modified by this proposed rule change. Second, the
Exchange believes that the changes proposed herein will not result in
any diminution of market quality (execution price, effective spread,
fill rate, etc.) for any member entering or interacting with one of the
Order types modified by this proposed rule change.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. To the contrary, the Exchange
believes the proposed rule changes are pro-competitive for several
reasons. First, the proposed functionality is designed to compete with
exchanges, including BATS and NYSE Arca, which already offer order
types that behave similarly to how the Exchanges proposes Post Only and
Non-Display Orders behave in the future. Second, the Exchange believes
that the proposed rule change will make the Exchange a more competitive
execution venue by creating tighter bid/offer spreads and by enhancing
execution quality (i.e., achieving increased price improvement,
reducing effective spreads, and increasing execution fill rates).
Third, the Exchange proposes to offer the same functionality to all
members, thereby eliminating potential competitive burden or
differential treatment.

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

    No written comments were either solicited or received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2016-111 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2016-111. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of 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; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2016-111 and should
be submitted on or before October 19, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2016-23323 Filed 9-27-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 179 (Monday, September 18, 2023)]
[Rules and Regulations]
[Pages 63840-63841]
[FR Doc No: 2023-20128]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 734

[Docket No.<PHONE_NUMBER>]
RIN 0694-AJ37

Export Administration Regulations (EAR): Transfer of Access
Information and Release of Software (Source Code and Object Code)

AGENCY: Bureau of Industry and Security, Department of Commerce.

ACTION: Final rule; technical correction.

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SUMMARY: In this final rule, the Bureau of Industry and Security (BIS)
amends the Export Administration Regulations (EAR) to make a technical
correction that also serves to clarify provisions of the EAR pertaining
to the release of ``software'' as set out in the sections on release
and transfer of access information. This final rule clarifies an
ambiguity in the EAR by adding a cross-reference addressing transfer of
access information in the section on releases of ``technology'' and
``software,'' as was originally intended. In addition, this final rule
adds a clarifying note that, for purposes of transfer of access
information, a release of ``software'' includes both source code and
object code.

DATES: This rule is effective September 18, 2023.

FOR FURTHER INFORMATION CONTACT: For questions on these technical
corrections, contact Eileen Albanese, Director, Office of National
Security and Technology Transfer Controls, Bureau of Industry and
Security, Department of Commerce, Phone:<PHONE_NUMBER>, Email:
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    In this final rule, BIS amends the EAR to make a technical
correction that also serves to clarify provisions of the EAR that
pertain to the release of ``software.'' On June 3, 2016, BIS published
the final rule, Revisions to Definitions in the Export Administration
Regulations (81 FR 35568) (June 3 rule). The June 3 rule added
provisions to address releases of ``technology'' and ``software'' under
Sec.  734.15 and transfer of access information under Sec.  734.19. In
Sec.  734.15, this final rule clarifies an ambiguity by adding a cross
reference to Sec.  734.19. In Sec.  734.19, this final rule adds a new
note to the section clarifying that for purposes of transfer of access
information, a release of ``software'' includes source code and object
code.

    The definition of the term ``software'' in Sec.  772.1 includes
both source code and object code, and ``software'' is used as a defined
term in Sec.  734.19. Accordingly, the note added in this rule will
eliminate potential uncertainty that the Sec.  734.15 definition of
``release'' limits Sec.  734.19 to only controlling transfers of access
information that release source code, rather than both source code and
object code.

Export Control Reform Act of 2018

    On August 13, 2018, the President signed into law the John S.
McCain National Defense Authorization Act for Fiscal Year 2019, which
included the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4801-
4852). ECRA provides the legal basis for BIS's principal authorities
and serves as the authority under which BIS issues this rule.

Rulemaking Requirements

    1. This rule has been determined to be not significant for purposes
of Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is
required to respond to or be subject to a penalty for failure to comply
with a collection of information, subject to the requirements of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless
that collection of information displays a currently valid Office of
Management and Budget (OMB) Control Number. This regulation involves an
information collection approved by OMB under control number 0694-0088,
Simplified Network Application Processing System. BIS does not
anticipate a change to the burden hours associated with this collection
as a result of this rule. Information regarding the collection,
including all supporting materials, can be accessed at https://www.reginfo.gov/public/do/PRAMain.
    3. This rule does not contain policies with federalism implications
as that term is defined in Executive Order 13132.
    4. Pursuant to section 1762 of the Export Control Reform Act of
2018, this action is exempt from the Administrative Procedure Act (5
U.S.C. 553) requirements for notice of proposed rulemaking, opportunity
for public participation, and delay in effective date.
    5. Because a notice of proposed rulemaking and an opportunity for
public comment are not required to be given for this rule by 5 U.S.C.
553, or by any other law, the analytical requirements of the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq., are not applicable.
Accordingly, no regulatory flexibility analysis is required, and none
has been prepared.

List of Subjects 15 CFR Part 734

    Administrative practice and procedure, Exports, Inventions and
patents, Research, Science and technology.

    Accordingly, 15 CFR part 734 is corrected by making the following
correcting amendments:

PART 734--SCOPE OF THE EXPORT ADMINISTRATION REGULATIONS

0
1. The authority citation for part 734 continues to read as follows:

    Authority: 50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50
U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p.
950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026,
61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3
CFR, 2001 Comp., p. 783; E.O. 13637, 78 FR 16129, 3 CFR, 2014 Comp.,
p. 223; Notice of November 8, 2022, 87 FR 68015 (November 10, 2022).

0
2. Section 734.15 is amended by revising paragraph (a) introductory
text to read as follows:

Sec.  734.15  Release.

    (a) Except as set forth in Sec. Sec.  734.18 and 734.19,
``technology'' and ``software'' are ``released'' through:
* * * * *

0
3. Section 734.19 is amended by adding a note at the end of the section
to read as follows:

Sec.  734.19  Transfer of access information.

* * * * *
    Note 1 to Sec.  734.19: For purposes of this section, a release of
``software'' includes source code and object code.

Thea D. Rozman Kendler,
Assistant Secretary for Export Administration.
[FR Doc. 2023-20128 Filed 9-15-23; 8:45 am]
BILLING CODE 3510-33-P


Comment No. 3: EPA's proposed approval will interfere with the
ozone attainment demonstration (with respect to the 1997 8-hour ozone
standard) for the Denver Metro area and interfere with the Early Action
Compact (EAC).
    EPA Response No. 3: These comments are no longer relevant since
much has changed regarding the EAC and Denver's ozone attainment status
between now and when the EPA first proposed approval of NSR Reform for
Colorado.
    Denver failed to meet the requirements of the EAC and, as of
November 2007, was designated nonattainment for the 1997 8-hour ozone
standard. Since that time, EPA has approved a SIP revision (76 FR
47443) for the State of Colorado that includes an attainment
demonstration by November 2010 for the Denver Metro Area. Ambient air
monitoring data also supports the attainment demonstration, with no
ozone monitors in the Denver Metro Area showing a violation of the 1997
8-hour ozone standard using design values from 2007-2009 (82 ppb) or
from 2008-2010 (78 ppb). Preliminary data from 2009-2011 also shows
attainment with respect to the 1997 8-hour ozone standard.
    Comment No. 4: Colorado is preparing to make substantial revisions
to its Inspection & Maintenance (I/M) program that will further
undermine the ozone attainment demonstration for the Denver Metro Area.
    EPA Response No. 4: The comment is outside the scope of this action
since EPA did not propose to take any action with respect to Colorado's
I/M program. Furthermore, many aspects of the I/M program in the Denver
Metro Area/North Front Range have changed since this comment was
originally made. On September 25, 2006, the State of Colorado submitted
a SIP submittal for the CAA section 175A(b) second 10-year carbon
monoxide (CO) maintenance plans for the Denver metropolitan and
Longmont areas. This SIP submittal also included revisions to
Colorado's Regulation Number 11 which included the removal of the I/M
program in both carbon monoxide maintenance areas. EPA approved these
second 10-year maintenance plan SIP revisions on August 17, 2007 (see
72 FR 46148). However, in our August 17, 2007 action, we drew special
attention to the point that the I/M program would continue in both
areas for purposes of the ozone element of the SIP: ``* * * the removal
of the I/M program from Denver's revised CO maintenance plan does not
mean the I/M program is eliminated. The State relies on the I/M program
in the Denver's 1-hour ozone maintenance plan and Denver's 8-hour ozone
Early Action Compact (EAC). Therefore, the motor vehicle I/M program
will remain intact in the Denver-metro area.'' (72 FR 46155, August 17,
2007). We also note that we had previously approved Fort Collins' and
Greeley's revised CO maintenance plans which also involved the removal
of the Basic I/M program from the SIP for both areas (see 68 FR 43316,
July 22, 2003 and 70 FR 48650, August 19, 2005, respectively). Those
actions effectively eliminated Basic I/M in Larimer and Weld Counties;
however, we note that those basic I/M programs had only been in place
for purposes of CO emission reductions.
    Colorado has submitted two other SIP revisions, after our August
17, 2007 Federal Register action, that involve amendments to Regulation
Number 11. Those revisions involve a low emitter index (LEI) of
vehicles with respect to the Clean Screen element of Regulation Number
11 and to eliminate obsolete provisions for gasoline filter neck
inspections and CFC (refrigerant) leak checks. The latter submittal has
since been withdrawn by the State and we have not acted on the LEI
submittal yet. However, we do note that since our most recent action to
Federally approve revisions to Colorado's Regulation Number 11 (see 72
FR 46148, August 17, 2007), Colorado has reinstated the I/M programs in
Larimer and Weld Counties for the purpose of reducing ozone precursor
emissions. These I/M programs contain State-only enforceable provisions
and the re-implementation of the I/M programs began on November 1,
2010. These State-only I/M expansion provisions for Larimer and Weld
Counties appear in Colorado's Regulation Number 11, Motor Vehicle
Emissions Inspection Program, 5 CCR 1001-13, current as State-adopted
on January 20, 2011; State-effective on March 2, 2011. We note that EPA
has approved an attainment demonstration of the 1997 8-hour ozone NAAQS
for the Denver Metro Area/North Front Range (76 FR 47443, August 5,
2011) and this attainment demonstration included ozone precursor
emission reductions from the continued implementation of Colorado's
Federally-approved I/M program. Furthermore, as stated above, ambient
data shows attaining monitors using design values from 2007-2009 (82
ppb) and from 2008-2010 (78 ppb). Preliminary data from 2009-2011 also
shows attainment with respect to the 1997 8-hour ozone standard.
    Comment No. 5: Title 1, Part C, Section 160 of the CAA states that
air quality in national parks must be protected. It is contrary to this
CAA section for EPA to approve a rule revision that would increase air
pollution in Colorado's Class I areas. Section 110(l) is proof that
such a SIP revision should not be approved.
    EPA Response No. 5: EPA's response to the air quality in national
parks issue raised by the commenters involves many of the same elements
of the response above to the section 110(l) comments, which is also
incorporated by reference here. EPA's national analysis in support of
the 2002 NSR Reform Rules indicates that the non-vacated provisions of
the NSR Reform Rules will have a neutral or beneficial impact.
    The primary issue raised by the commenters was the impact of
nitrogen deposition in Rocky Mountain National Park (RMNP) which
resides fully within the boundaries of Colorado. The commenters
incorporate by reference a September 1, 2004 petition to the

Department of Interior (DOI) from Colorado Trout Unlimited and
Environmental Defense. The petition asks DOI to ``[c]all for the EPA
and the State of Colorado to fulfill their legal responsibilities to
lower NOX and Ammonia to protect human health, plants and
ecosystems, and scenic vistas at Rocky Mountain National Park and to
fully mitigate nitrogen deposition above the identified critical
load.'' Partly in response to this petition, a Memorandum of
Understanding was signed by the National Park Service, EPA, and the
CDPHE to form the RMNP Initiative. The agencies agreed to pursue a more
in-depth review of the issues related to nitrogen deposition in RMNP
and a course of action to address them. As a result, the Initiative
formulated the ``Nitrogen Deposition Reduction Contingency Plan'' which
was endorsed by the Colorado Air Quality Control Commission (AQCC) on
June 17, 2010. The plan includes goals for reducing nitrogen deposition
incrementally over 5 year periods with contingencies in place should
these goals not be reached.
    In addition to the contingency measures adopted by the multi-agency
plan, it is expected that current and future ozone planning in Colorado
should positively impact nitrogen deposition in RMNP. Reduction in
ozone precursors (e.g. NOX) that result from the control
measures adopted in Colorado's recent federally approved ozone
attainment demonstration SIP will also contribute to a reduction of
nitrogen deposition in RMNP.
    Furthermore, Colorado is subject to the Protection of Visibility
requirements at 40 CFR part 51, subpart P, including the Reasonably
Attributable Visibility Impairment (RAVI) requirements, the Regional
Haze requirements, and the Grand Canyon Visibility Transport Commission
requirements. Each of these programs requires Colorado to achieve a
variety of emissions reductions aimed at protecting visibility in
national parks and other Class I areas. In particular, EPA expects that
Colorado's SIP revision submission to meet the Regional Haze
requirements, including both the Best Available Retrofit Technology
(BART) controls and the long-term strategy for regional haze, will
provide NOX reductions that will reduce the nitrogen
deposition in RMNP.

III. Final Action

    EPA is approving portions of Colorado's revisions to Regulation No.
3, submitted by Colorado on July 11, 2005 and October 25, 2005, that
relate to the PSD and NSR construction permits program. These revisions
meet the minimum program requirements of the December 31, 2002, EPA NSR
Reform rulemaking. Several of the remaining revisions made by Colorado
to Regulation No. 3 as adopted on April 16, 2004 by the Colorado AQCC
are being acted on by EPA in a separate final action related to
Colorado's Interstate Transport SIP (see proposed action at 76 FR
21835, April 19, 2011).

IV. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
    This rule also does not have tribal implications because it will
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, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does not have substantial direct effects 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, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999). This action merely approves a state rule
implementing a Federal standard, and does not alter the relationship or
the distribution of power and responsibilities established in the Clean
Air Act. This rule also is not subject to Executive Order 13045
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it approves a state rule
implementing a Federal standard.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    The Congressional Review Act, 5 U.S.C. section 801 et seq., as
added by the Small Business Regulatory Enforcement Fairness Act of
1996, generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of the rule in the Federal Register. A major rule
cannot take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
section 804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by June 11, 2012. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate

matter, Reporting and recordkeeping requirements, Sulfur oxides,
Volatile organic compounds.

    Dated: December 21, 2011.
James B. Martin,
Regional Administrator, Region 8.

    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart G--Colorado

0
2. Section 52.320 is amended by adding paragraph (c)(122) to read as
follows:

Sec.  52.320  Identification of plan.

* * * * *
    (c) * * *
    (122) The State of Colorado submitted revisions October 25, 2005 to
Colorado's 5 CCR 1001-5 Regulation Number 3, Part A and Colorado's 5
CCR 1001-5 Regulation Number 3, Part D. The October 25, 2005 submittal
included language changes and renumbering of Regulation Number 3. The
incorporation by reference in ((i)(A) and (i)(B) reflects the
renumbered sections and language changes as of the October 25, 2005
submittal.
    (i) Incorporation by reference.
    (A) 5 CCR 1001-5, Regulation 3, Stationary Source Permitting and
Air Contaminant Emission Notice Requirements, Part A, Concerning
General Provisions Applicable to Reporting and Permitting, adopted
April 16, 2004 and effective June 30, 2004:
    Section I, Applicability, Sections I.B, Definitions; I.B.7,
Allowable Emissions; I.B.13, Continuous Emissions Monitoring System
(CEMS); I.B.14, Continuous Emissions Rate Monitoring Systems (CERMS);
I.B.15, Continuous Parameter Monitoring System (CPMS); I.B.33,
Pollution Prevention; I.B.35, Potential to Emit; I.B.36, Predictive
Emissions Monitoring System (PEMS); adopted April 16, 2004 and
effective June 30, 2004.
    (B) 5 CCR 1001-5, Regulation 3, Stationary Source Permitting and
Air Contaminant Emission Notice Requirements, Part D, Concerning Major
Stationary Source New Source Review and Prevention of Significant
Deterioration, adopted April 16, 2004 and effective June 30, 2004:
    (1) Section I, Applicability,
    (i) I.A., General Applicability; I.A.2; I.A.3;
    (ii) I.B, Applicability Tests; I.B.1; I.B.2; I.B.4 (except the
final sentence beginning, ``For example[hellip]''); I.B.5;
    (iii) I.C;
    (2) Section II, Definitions,
    (i) II.A;
    (ii) II.A; II.A.1, Actual Emissions; II.A.1.a (only the language
that appears as plain or italicized text); II.A.1.c (only the language
that appears as plain text); II.A.1.d;
    (iii) II.A.2, Actuals PAL;
    (iv) II.A.4, Baseline Actual Emissions;
    (v) II.A.7, Begin Actual Construction;
    (vi) II.A.9, Clean Coal Technology;
    (vii) II.A.10, Clean Coal Technology Demonstration Project;
    (viii) II.A.13, Construction;
    (ix) II.A.14, Emissions Unit;
    (x) II.A.15, Electric Utility Steam Generating Unit;
    (xi) II.A.17, High Terrain;
    (xii) II.A.18, Hydrocarbon Combustion Flare;
    (xiii) II.A.20, Low Terrain;
    (xiv) II.A.21, Lowest Achievable Emission Rate (LAER); II.A.21.b
(only the language that appears as plain or italicized text);
    (xv) II.A.22, Major Emissions Unit;
    (xvi) II.A.23, Major Modification (only the language that appears
as plain and italicized text); II.A.23.d.(iii); II.A.23.d(x);
II.A.23.d(xi); II.A.23.e;
    (xvii) II.A.25, Major Stationary Source; II.A.25.b (only the
language that appears as plain or italicized text);
    (xviii) II.A.27, Net Emissions Increase; II.A.27.a.(i) (only the
language that appears as plain or italicized text); II.A.27.a.(ii);
II.A.27.b; II.A.27.g.(iii) (only the language that appears as plain or
italicized text); II.A.27.i;
    (xix) II.A.28, Nonattainment Major New Source Review (NSR) Program;
    (xx) II.A.29, PAL Effective Date;
    (xxi) II.A.30, PAL Effective Period;
    (xxii) II.A.31, PAL Major Modification;
    (xxiii) II.A.32, PAL Permit;
    (xxiv) II.A.33, PAL Pollutant;
    (xxv) II.A.34, Plantwide Applicability Limitation (PAL);
    (xxvi) II.A.36, Prevention of Significant Deterioration (PSD)
Permit;
    (xxvii) II.A.37, Project;
    (xxviii) II.A.38, Projected Actual Emissions;
    (xxvix) II.A.39, Reactivation of Very Clean Coal-fired Electric
Utility Steam Generating Unit;
    (xxx) II.A.41, Replacement Unit;
    (xxxi) II.A.42, Repowering;
    (xxxii) II.A.43, Secondary Emissions;
    (xxxiii) II.A.46, Significant Emissions Unit;
    (xxxiv) II.A.47, Small Emissions Unit;
    (xxxv) II.A.48, Temporary Clean Coal Technology Demonstration
Project;
    (3) Section V, Requirements Applicable to Nonattainment Areas,
V.A.7.c (except for the phrases, ``a Clean Unit or at'', ``a reasonable
possibility that'', and ``may result in a significant emissions
increase''); V.A.7.d;
    (4) Section VI, Requirements applicable to attainment and
unclassifiable areas and pollutants implemented under section 110 of
the Federal Act (Prevention of Significant Deterioration Program),
Sections VI.A.1.c (only the language that appears as plain or
italicized text); VI.B.5 (except for the phrases, ``a Clean Unit or
at'', ``a reasonable possibility that'', and ``may result in a
significant emissions increase''); VI.B.6;
    (5) Section XVII, Actuals PALs; adopted April 16, 2004 and
effective June 30, 2004.

[FR Doc. 2012-8349 Filed 4-9-12; 8:45 am]
BILLING CODE P


[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3826-3827]
[FR Doc No: 2014-01232]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1574]

Medical Devices Containing Materials Derived From Animal Sources
(Except for In Vitro Diagnostic Devices); Draft Guidance for Industry
and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Medical Devices
Containing Materials Derived From Animal Sources (Except for In Vitro
Diagnostic Devices).'' FDA is issuing this draft guidance to update the
policy regarding the use of animal-derived material in medical device
manufacturing. These animal-derived materials may carry a risk of
transmitting infectious disease when improperly collected, stored, or
manufactured. The guidance describes the information you should
document at the manufacturing facility and include in any premarket
submissions. This draft guidance is not final nor is it in effect at
this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 23, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Medical Devices Containing Materials
Derived From Animal Sources (Except for In Vitro Diagnostic Devices)''
to the Division of Small Manufacturers, International and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request, or fax your request to 301-847-
8149. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify

comments with the docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Scott McNamee, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3416, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Charles Durfor, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G424,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance entitled ``Medical Devices Containing Materials
Derived From Animal Sources (Except for In Vitro Diagnostic Devices)''
is intended to update the 1998 guidance of the same name regarding the
use of animal-derived material in medical device manufacturing. The
1998 guidance addressed ways to reduce the potential for exposure to
bovine spongiform encephalopathy. The draft guidance continues to focus
on the control of transmissible disease, and contains recommendations
for documenting the source of animal tissue, conducting viral
inactivation validation studies, as well as recommendations about the
role of careful animal husbandry in ensuring safe tissue sources.
    The information in this guidance is applicable to all medical
devices that contain or are exposed to animal-derived materials (e.g.,
bovine, ovine, porcine, avian materials) with the exception of in vitro
diagnostic devices. The guidance describes the information you should
document at the manufacturing facility and include in any premarket
submissions. Consideration of these issues should aid in reducing the
risk of infectious disease transmission by medical devices.
    This draft guidance, when finalized, will supersede the guidance
entitled ``Medical Devices Containing Materials Derived from Animal
Sources (Except for In Vitro Diagnostic Devices)'', announced in the
Federal Register of November 6, 1998 (63 FR 60009).

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on medical
devices containing materials derived from animal sources (except for in
vitro diagnostic devices). It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``Medical Devices Containing Materials Derived from Animal Sources
(Except for In Vitro Diagnostic Devices)'' you may either send an email
request to<EMAIL_ADDRESS>to receive an electronic copy of the
document or send a fax request to<PHONE_NUMBER> to receive a hard copy.
Please use the document number 2206 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807 subpart E have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 812 have been approved under OMB control
number 0910-0078; the collections of information in 21 CFR part 814
have been approved under OMB control number 0910-0231; the collections
of information in 21 CFR part 814 subpart H have been approved under
OMB control number 0910-0332; and the collections of information in 21
CFR part 820 have been approved under OMB control number 0910-0073.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: January 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01232 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 162 (Wednesday, August 25, 2021)]
[Proposed Rules]
[Pages 47422-47424]
[FR Doc No: 2021-18253]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0700; Project Identifier 2019-CE-017-AD]
RIN 2120-AA64

Airworthiness Directives; Costruzioni Aeronautiche Tecnam S.P.A.
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Costruzioni Aeronautiche Tecnam S.P.A. Model P2006T airplanes.
This proposed AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as a manufacturing
defect in the nose landing gear (NLG) piston tube. This proposed AD
would require replacing the NLG piston tube. The FAA is proposing this
AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by October 12,
2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact
Costruzioni Aeronautiche Tecnam S.P.A, Via S. D'acquisto 62, 80042
Boscotrecase (NA), Italy; phone: + 39 0823 620134; fax: +

39 0823 622899; email<EMAIL_ADDRESS>website: https://www.tecnam.com/us/support/. You may view this service information at
the FAA, Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, MO 64106. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0700; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, the MCAI,
any comments received, and other information. The street address for
Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aviation Safety
Engineer, General Aviation & Rotorcraft Section, International
Validation Branch, FAA, 901 Locust, Room 301, Kansas City, MO 64106;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0700; Project Identifier
2019-CE-017-AD'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Jim
Rutherford, Aviation Safety Engineer, General Aviation & Rotorcraft
Section, International Validation Branch, FAA, 901 Locust, Room 301,
Kansas City, MO 64106. Any commentary that the FAA receives which is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Background

    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Union, has issued
EASA AD 2019-0043, dated March 6, 2019 (referred to after this as ``the
MCAI''), to correct an unsafe condition on Costruzioni Aeronautiche
Tecnam S.P.A. Model P2006T airplanes. The MCAI states:

    Failures of NLG piston tubes P/N 26-8-1408-1 were reported
during ground operations. Subsequent investigation determined a
deficiency in NLG piston tube manufacturing process. It was also
determined that only a specific batch is affected by this defect.
    This condition, if not corrected, could lead to failure of the
NLG, possibly resulting in loss of control on the ground, during or
after landing, with consequent damage to the aeroplane and injury to
occupants.
    To address this potential unsafe condition, TECNAM issued the
[service bulletin] SB to provide instructions for the replacement of
each affected part with a part that was manufactured by an improved
process.
    For the reasons described above, this [EASA] AD requires removal
from service of the affected parts.

    You may examine the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0700.

Related Service Information

    Costruzioni Aeronautiche Tecnam S.P.A. Service Bulletin No. SB 288-
CS-Ed 1, Revision 1, dated December 22, 2017, is related to this NPRM
and provides information about installing nose landing gear (NLG)
piston tube kit number SB 288-1.

FAA's Determination

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI and
service information referenced above. The FAA is issuing this NPRM
after determining the unsafe condition described previously is likely
to exist or develop on other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require replacing NLG piston tubes that are
not P/N 26-8-1408-1 and marked ``rev F00.''

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 59 airplanes of U.S. registry. The FAA also estimates that it
would take about 4 work-hours per airplane to comply with the
replacement required by this proposed AD. The average labor rate is $85
per work-hour. Required parts would cost about $1,200 per airplane.
    Based on these figures, the FAA estimates the cost of this proposed
AD on U.S. operators to be $90,860, or $1,540 per airplane.
    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected operators.

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.
    The FAA is 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

    The FAA 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) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

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

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

Sec.  39.13  [Amended]

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

Costruzioni Aeronautiche Tecnam S.P.A.: Docket No. FAA-2021-0700;
Project Identifier 2019-CE-017-AD.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by October 12, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Costruzioni Aeronautiche Tecnam S.P.A. Model
P2006T airplanes, all serial numbers, certificated in an category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 3220, Nose/Tail
Landing Gear.

(e) Unsafe Condition

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and address an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as a manufacturing
defect in the nose landing gear (NLG) piston tube. The unsafe
condition, if not addressed, could result in failure of the NLG upon
or after landing.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    (1) For airplanes with an NLG piston tube part number (P/N) 26-
8-1408-1 installed and not marked ``rev. F00'': Within 50 hours
time-in-service after the effective date of this AD or within 2
months after the effective date of this AD, whichever occurs first,
replace any P/N 26-8-1408-1 NLG piston tube with an improved part by
installing NLG piston tube kit number SB 288-1.
    (2) As of the effective date of this AD, do not install an NLG
piston tube P/N 26-8-1408-1 on any airplane unless it is marked
``rev. F00.''

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the certification office, send it to the
attention of the person identified in Related Information or email:
<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(i) Related Information

    (1) For more information about this AD contact Jim Rutherford,
Aviation Safety Engineer, General Aviation & Rotorcraft Section,
International Validation Branch, FAA, 901 Locust, Room 301, Kansas
City, MO 64106; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to European Union Aviation Safety Agency (EASA) AD
2019-0043, dated March 6, 2019, for more information. You may
examine the EASA AD in the AD docket at https://www.regulations.gov
by searching for and locating Docket No. FAA-2021-0700.
    (3) For service information identified in this AD, contact
Costruzioni Aeronautiche Tecnam S.P.A, Via S. D'acquisto 62, 80042
Boscotrecase (NA), Italy; phone: + 39 0823 620134; fax: + 39 0823
622899; email<EMAIL_ADDRESS>website: https://www.tecnam.com/us/support/. You may review this referenced service
information at the FAA, Airworthiness Products Section, Operational
Safety Branch, 901 Locust, Kansas City, MO 64106. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued on August 19, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-18253 Filed 8-24-21; 8:45 am]
BILLING CODE 4910-13-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Venus Eagle (PM 01),<PHONE_NUMBER>.
Arysta LifeScience North America, LLC
Petition #5F8364

Summary of Petition
EPA has received a pesticide petition (5F8364) from Arysta LifeScience North America Corporation, 15401 Weston Parkway, Suite150, Cary NC 27513 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by amending the existing tolerance for residues of 3-dodecyl-1,4-dihydro-1,4-dioxo-2-naphthyl acetate and its metabolite 2-dodecyl-3-hydroxy-1,4-naphthoquinone expressed as acequinocyl equivalents in or on Hop, dried cones from 4.0 to 15.0 parts per million (ppm). EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry
1. Plant metabolism. The nature of the residues of acequinocyl in plants is adequately understood as studies have been conducted on three crops; apples, oranges and eggplant. The major residue in all plant metabolism studies is acequinocyl. A minor but significant metabolite is acequinocyl-OH (2-dodecyl-3-hydroxy-1,4-naphthoquinone). The proposed tolerance expression is the parent, acequinocyl and its hydroxy metabolite, acequinocyl-OH.

2. Analytical method. The analytical method to quantitate residues of acequinocyl and acequinocyl-OH in/on fruit crops utilizes high pressure liquid chromatography (HPLC) using mass spectrometric (MS/MS) detection. The target limit of quantitation (LOQ) is 0.01 ppm.

3. Magnitude of residues.  The existing use of acequinocyl calls for a maximum of 2 applications per season at 0.3 lb a.i. per acre per application (maximum 0.6 lb a.i. per acre per season), with a 21-day interval between applications. The pre-harvest interval is 7 days. The established tolerance expressed as acequinocyl equivalents in/on Hops, dried cones is 4.0 ppm.  Arysta seeks to raise the tolerance to 15 ppm in order to match the tolerance values established in the European Union and Japan.

B. Toxicological Profile
The complete toxicity profile of acequinocyl was previously published in the Federal Register of November 17, 2010 (73 FR 70143).

1. Acute toxicity. Acequinocyl technical has low acute, dermal and inhalation toxicity in laboratory animals. The oral LD50 (M/F) in the rat and mouse was > 5000 mg/kg. The dermal LD50 (M/F) was > 2000 mg/kg. The inhalation LC50 was reported as > 0.84 mg/l. In the eye and dermal irritation studies, acequinocyl technical was not an eye or skin irritant to rabbits and was not a skin sensitizer in guinea pigs.

2. Genotoxicty.  Acequinocyl was found to be negative in the Ames reverse mutation, mouse lymphoma, Chinese hamster lung (CHL) chromosome aberration and mouse micronucleus assays.

3. Reproductive and developmental toxicity.
i. Rat teratology. Acequinocyl technical was administered by oral gavage to pregnant Sprague Dawley rats at dose levels of 0, 50, 150, 500 or 750 mg/kg/day. Common signs in the descendants included vaginal discharge, pallor, pale eyes, hypoactivity, piloerection, slow or irregular breathing, intra-uterine hemorrhage and blood stained stomach and/or intestinal contents. Maternal NOEL=150 mg/kg/day based on these signs. Developmental NOEL=500 mg/kg/day based on increase in certain skeletal variants that may be attributed to the observed maternal toxicity.
 ii. Rabbit teratology. Groups of New Zealand white rabbits received acequinocyl technical by gavage at doses of 0, 30, 60 or 120 mg/kg/day. Maternal NOEL=60 mg/kg/day based on reduction in maternal body weight and 5 females were sacrificed at 120 mg/kg/day. Fetal NOEL=60 mg/kg/day due to skeletal variations in the thoraco-lumbar ribs.
iii. Rat reproduction study. Acequinocyl technical was fed to two generations of male and female Sprague Dawley rats at dietary concentrations of 0, 100, 800, or 1500 ppm (0, 7.3, 59 or 111 mg/kg/day for males and 0, 8.7, 69 or 134 mg/kg/day for females). Systemic and pup NOEL=100 ppm (7.3 and 8.7 mg/kg/day). Systemic: Hemorrhage and swollen body parts were seen at 800 and 1500 ppm in F1 males . At 800 and 1500 ppm, treatment related clinical signs, hemorrhagic effects, subcutaneous bleeding on body parts and/or cranium and/or brain were seen in the F1 pups. At 800 and 1500 ppm toxicity seen in F2 pups included subcutaneous bleeding on body parts and/or cranium and/or brain at weaning.

4. Subchronic toxicity.
i. Rat feeding study. Fischer rats received acequinocyl technical at dietary concentrations of 0, 100, 400, 1600 or 3200 ppm (0, 7.57, 30.4, 120, 253 mg/kg/day, respectively for males and 0, 8.27, 32.2, 129, 286 mg/kg/day, respectively for females) for 13 consecutive weeks. Treatment related yellow brown urine in all animals of both sexes at 400 ppm suggested the presence of the metabolite of the test material. Macroscopic examination on the surviving animals revealed no treatment related abnormalities. At 3200 and 1600 ppm, macroscopic and microscopic examination of the mortalities revealed hemorrhaging of muscle and other organs. NOEL=400 ppm (30.4 mg/kg/day for males and 32.2 mg/kg/day for females).
ii. Mouse feeding study. Groups of CD-1 (ICR) BR mice received acequinocyl technical by oral route at concentrations of 0, 100, 500, 1000 or 1500 ppm (0, 16, 81, 151, 295 mg/kg/day respectively for males and 0, 21, 100, 231, 342 mg/kg/day respectively for females) for 13 weeks. At 100 ppm, there were hepatic histopathological lesions and an increase in relative liver weight. A clear NOEL for both sexes was not determined.
iii. Dog feeding study. Acequinocyl technical was administered via gelatin capsule to male and female beagle dogs at dose levels of 0, 40, 160, 640 or 1000 mg/kg/day once a day 7 days a week for 13 weeks.  At 40, 160 and 640 mg/kg/day colored feces were observed in both sexes. At 160 and 640 mg/kg/day, treatment related decrease in body weight gain in males and an increase platelet count for females was observed. Macroscopic and microscopic examinations on the surviving animals revealed no treatment related abnormalities. A clear NOEL was not determined.
iv. 28-day dermal toxicity. Groups of Sprague Dawley rats received daily dermal applications of acequinocyl technical at doses of 0, 40, 200 or 1000 mg/kg/day for 6 hours/day for 28 days followed by a 14 day treatment free period only in the high dose group. There were no macroscopic findings. Red staining occurred on the back of the animals and was only seen in the morning after dosing. There was no evidence of systemic toxicity. NOEL=1000 mg/kg/day.

5. Chronic toxicity.
i. Dog feeding study. Beagle dogs were dosed by capsule at 0, 5, 20, 80 or 320 mg/kg/day for 1 year with acequinocyl technical. Minor disturbances in platelet counts were observed in both sexes at 80 and 320 mg/kg/day. There were no treatment related macroscopic histopathological findings. Colored feces and/or abnormally stained sawdust were observed for all treatment groups. Varying degrees of discoloration of the urine was observed for animals receiving 20 mg/kg/day or more. The discoloration was considered to be attributable to a colored metabolite of the test substance. NOEL=20 mg/kg/day.
ii Rat feeding/oncogenicity study. Groups of F344 rats received acequinocyl technical at dietary levels of 0, 50, 200, 800 or 1600 ppm (0, 2.25, 9.02, 36.4, 74.0 mg/kg/day for males and 0, 2.92, 11.6, 46.3, 93.6 mg/kg/day for females) for 2 years. NOEL=200 ppm (9.02 and 11.6 mg/kg/day for males and females respectively). Corneal abnormalities and hypertrophy of the eye were observed in 800 ppm and 1600 ppm males and 1600 ppm females. At 800 ppm and 1600 ppm, PT was observed to be longer in males and shorter in females and APTT longer in females. Reddish brown urine was observed in both males and females. There was no incidence of tumors.
iii. Mouse oncogenicity study. Acequinocyl technical was administered in the diet of Crl:CD-1(ICR)BR mice at 0, 20, 50, 150 or 500 ppm for 80 weeks. NOEL=20 ppm (lowest dose tested equal to 2.7 and 3.5 mg/kg/day in males and females respectively), based on brown pigmented cells. At 50 and 500 ppm in both sexes, there was an increase incidence of fatty hepatocytes. Other associated findings were increased liver weight, slight increase in pale livers or pale areas within livers. Glomerular amyloidosis was statistically increased in the 150 and 500 ppm males. Yellow brown urine was consistently found in both sexes at high dose. There was no increase in the incidence of tumors.

6. Animal metabolism. Sprague Dawley rats were dosed orally with acequinocyl labeled 14C-phenyl or 14C-dodecyl. Both labels were used in the single low dose (10 mg/kg) study. The high dose (500 mg/kg) and 14-day repeat dose studies (10 mg/kg/day) were conducted with 14C-phenyl acequinocyl only. Excretion was rapid, with most of the dose in the feces. Less than 15% of the radioactivity was found in the urine. Absorption was about 25-42% based on the bile duct cannulation studies, which found 20-33% of the administered dose in bile, plus 5-9% in urine plus cage wash. Acequinocyl was not detected in urine and was only a minor component (1-2%) in the feces. The major fecal metabolite (12-36%) was the 2-hydroxy-3-dodecyl-1,4-naphthalenedione (acequinocyl-OH or designated R1). Subsequent oxidation of the dodecyl chain yielded butanoic and hexanoic acids, the only measurable identified urinary metabolites. 2-(1,2-dioxotetradecyl)-benzoic acid comprised 19-40% of the radioactivity in the feces. There were no remarkable differences in metabolite disposition due to gender and no effect of pre-dosing for 2 weeks. The large dose slowed transit time and reduced absorption.

7. Metabolite toxicology. NA-Remove.

8. Endocrine disruption. A standard battery of toxicity tests have been conducted on acequinocyl. No effects were seen to indicate that acequinocyl has an effect on the endocrine system.

9. Immunotoxicity. NA-Remove.

C. Aggregate Exposure
1. Dietary exposure.
i. Food. Tolerance-level residues and 100% CT data were used in the chronic dietary assessment.  DEEM default processing factors were used with the exception of those for grape juice and raisins.  As residues were reduced in both grape juice (<0.02x) and raisin (0.15x), separate tolerances are not required for these commodities.  The DEEM ver. 7.81 default processing factors for juice and raisin were set to "1" as concentration was shown not to occur (Levy et al, 2011).  The chronic dietary assessment was based on the most recent dietary risk assessment for acequinocyl (Levy et al, 2011).
Permanent tolerances are currently established under 40 CFR §180.599(a) for the combined residues of acequinocyl and its metabolite, acequinocyl-OH, expressed as acequinocyl equivalents, in/on a number of plant and livestock commodities.  Tolerances for plant commodities range from 0.02 ppm (tree nuts and pistachios) to 30 ppm (citrus oil), and tolerances for livestock commodities are established at 0.02 ppm in the fat and liver of cattle, goat, horse, and sheep.
As cowpea forage and hay are significant feedstuff for livestock (dairy cattle only), the maximum reasonable balanced diet (MRBD) for acequinocyl was recalculated by EPA in 2011 using the Agency's most recent guidance on constructing reasonably balanced livestock diets (Science Advisory Council for Chemistry (ChemSAC) memo, 30-JUN-2008).  The beef cattle MRBDs did not need to be recalculated as cowpea forage and hay are not beef feed items.  The feeding study data indicate that the currently established tolerance level of 0.02 ppm for residues in cattle, goat, horse, and sheep fat is appropriate.  Furthermore, the 0.02 ppm residue level is sufficient to cover residues of the additional metabolite (AKM-15) of concern in ruminant liver and kidney.  The established 0.02 ppm residue level in cattle, goat, horse, and sheep liver are appropriate; however, the commodity definition should be changed to "meat byproducts" rather than "liver."

ii. Drinking water. There are no drinking water monitoring data available for acequinocyl or its metabolite acequinocyl-OH (R1), the residues of concern.  Groundwater estimated drinking water concentrations (EDWCs) were generated by EPA for acequinocyl using the Screening Concentration in Ground Water (SCI-GROW) Model.  Surface water EDWCs were generated using the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) model for all proposed uses except cranberry.  Since cranberry harvesting may involve field flooding and PRZM/EXAMS is not currently capable to assess this type of scenario, cranberry was assessed using the provisional cranberry model.  The most conservative EDWC value was 6.69 ppb (0.00669 ppm) derived via the surface water Approach #1 for the use pattern in cherries and grapes.  The upper-bound value of 6.69 ppb was used in the DEEM-FCID model for "water, direct, all sources" and "water, indirect, all sources" (Levy et al, 2011).

2 Non-dietary exposure.
i. Residential Handler:  Acequinocyl is currently registered for use on landscape ornamentals in and around residences, businesses, public property, schools, interiorscapes, and other non-production areas by commercial applicators and homeowners.  Therefore, there is the potential for residential handler exposure when applying to landscape ornamentals and ornamental or fruit trees.  Based upon the proposed use pattern, the following two residential handler scenarios were assessed by EPA (Lowe, 2007):

      (1) mixing/loading/applying liquids with low pressure handwand
      (2) mixing/loading/applying liquids with hose-end sprayer

Because no chemical-specific data were available with which to assess potential exposure to pesticide handlers, the estimates of exposure were based upon surrogate study data from the ORETF and PHED.

New residential handler exposure and risk assessments were conducted using the EPA 2012 Residential SOPs which contain updated surrogate unit exposures and input parameters.  As in 2007, homeowner handler assessments are based on the assumption that individuals are wearing shorts, short-sleeved shirts, socks, and shoes.  Residential handler exposure scenarios are considered to be short-term only, due to the infrequent use patterns associated with homeowner products.

Table 1 presents the exposure/risks for residential short-term dermal and inhalation exposures.  Based on the residential handler assessment, there are no risks of concern for residential handlers (i.e., MOEs > 100).

Table 1:  Residential Handler Exposure and Risks

                                  Dermal and
                    Inhalation Unit Exposures (mg/lb ai)[1]
                               Application Rate
                               (lb ai/gallon)[2]
                       Amount Handled Daily[1] (gallons)
                             Doses (mg/kg/day)[3]
                                    MOEs[4]
          Mixer/Loader/Applicator  -  Manually Pressurized Handwand
                                    Dermal
                                      63
                                    0.00125
                                       5
                                    Dermal
                                    0.00492
                                    Dermal
                                    40,635
                                  Inhalation
                                    0.0018

                                  Inhalation
                                    1.4E-06
                                  Inhalation
                                   4.27E+07
                  Mixer/Loader/Applicator  - Hose-End Sprayer
                                    Dermal
                                      58
                                    0.00125
                                      11
                                    Dermal
                                    0.00997
                                    Dermal
                                    20,000
                                  Inhalation
                                    0.0014

                                  Inhalation
                                    2.4E-06
                                  Inhalation
                                    2.49E+08
[1]From 2012 EPA Residential SOPs
[3]Application rate is the maximum application rate determined from the label for acequinocyl
      [2]Dose (mg/kg/day) = Unit exposure (mg/lb ai) x App Rate (lb ai/gal) x Amount Handled (gal/day) x  % Absorption (100%) /Body weight (80 kg)
[4]MOE = NOAEL/Dose; where the short-term dermal NOAEL = 200 mg/kg/day and short-term inhalation NOAEL = 60 mg/kg/day

ii.  Residential Post-Application:  With respect to residential post-application exposures, new HED policy (2012 Residential SOPs) specifies that there is potential for post-application dermal exposure following applications to residential landscape ornamentals and trees, either by adults or children between the ages of 6 and 11; therefore, a new residential post-application assessment was conducted.
Using the input parameters provided in Table 2-3 of the 2012 Residential SOPs, dermal re-entry exposure for adults and children to treated ornamentals and treated trees was calculated.  The exposures were compared to the dermal NOAEL of 200 mg/kg/day to generate a margin of exposure.  All margins of exposure exceed 100, indicating acceptable risk.

Table 2:  Residential Post-Application Dermal Risks
                                 Use Scenario
                             Application Rate[1]
                                   (lb ai/A)
                                  TC (cm2/hr)
                              Exposure Time (hr)
                          Dermal Dose (mg/kg/day)[2]
                                    MOE[3]
                                    Adults
                                Garden re-entry
                                     0.21
                                     8400
                                      2.2
                                    0.1359
                                     1,470
                                 Tree re-entry

                                     1700
                                      1.0
                                    0.0125
                                     2,148
                         Children (6 to <11 years)
                                Garden re-entry
                                     0.21
                                     4600
                                      1.1
                                    0.0931
                                    15,986
                                 Tree re-entry

                                      930
                                      0.5
                                    0.00855
                                    23,378
[1]Application rate = 0.00125 lb ai/gallon x 5 gallons/day / 0.03 A (spot treatment)
[2]Daily dose = DFR x TC x ET / BW (80 kg adults; 32 kg children)  DFR = 25% of the application rate
[3]MOE = NOAEL/Dermal Dose where the short-term dermal NOAEL = 200 mg/kg/day

D. Cumulative Effects
There is no information available to indicate that toxic effects produced by acequinocyl are cumulative with those of any other compound.  Arysta LifeScience North America, LLC will submit information, if necessary, for EPA to consider concerning potential cumulative effects of fluoxastrobin consistent with the schedule established by EPA at 62 Federal Register 42020 (Aug. 4, 1997) and other EPA publications pursuant to the Food Quality Protection Act.

E. Safety Determination
1. US Population.
 i. Short-Term Aggregate Risk: Short-term aggregate risk is made up of average dietary exposures from food and drinking water sources, and dermal and inhalation residential exposures.  Since acequinocyl has a residential use on ornamentals, adult residential handler exposure and post-application exposure is possible.  In addition, there is potential for children between the ages of 6 and 11 to come into dermal contact with foliar residues.  Based on the chronic dietary exposure, the "total US population" is the highest exposed adult population and can be considered protective of the other adult subgroups; therefore, this population was chosen for the aggregate risk assessment along with children, ages 6 to 12, as this most closely matches the subgroup that has potential for residential exposure through dermal post-application activities.  The results of the short-term aggregate risk assessment are shown in Table 3.

Dietary (food and drinking water) exposure is based on a Tier 1 (unrefined) chronic dietary exposure assessment (see Table 2).  Residential exposure estimates are conservative estimates due to the standard assumptions that were built into the calculations.  Residential exposure estimates were taken from Tables 1 and 2.  The short-term aggregate risk calculations for the general U.S. population and children, 6 to 12 years old, are shown below in Table 3.  Both aggregate MOEs are greater than 100 and therefore are not of concern.

Table 3:  Short-Term Aggregate Risk Calculations.
                                  Population
                                Dietary MOE[1]
                           Residential Dermal MOE[2]
                         Residential Inhalation MOE[2]
                                   Aggregate
                                    MOE[3]
                                U.S. Population
                                    16,211
                                     1,370
                                   4.27E+07
                                     1,263
                            Children, 6 to 12 years
                                    12,002
                                     2,148
                                      NA
                                     1,822
[1]  Dietary MOE = short-term oral NOAEL (60 mg/kg/day)  chronic dietary exposure.
[2]  Residential MOEs are from Tables 3 and 4.  The "hose-end sprayer" scenario was used for the general US population as the MOE for this scenario is lower (more conservative) than the "manually pressurized handwand" MOE; the hose-end sprayer dermal dose was added to the garden reentry dose.  For children, the garden reentry dermal dose was used as the MOE for this scenario is lower than for tree reentry.
[3]  Aggregate MOE (dietary and residential) = 1((1MOEdietary)+(1MOEdermal)+(1MOEinhalation)); LOC = 100.

ii. Intermediate-Term Aggregate Risk:  Intermediate-term aggregate risk was not calculated since the use pattern is not expected to result in residential handler or post-application exposure of more than 30-day duration.

iii. Long-Term Aggregate Risk:  Chronic (long-term) aggregate risk is made up only of dietary sources; therefore, the chronic exposure estimates provided in the chronic dietary exposure analysis (see Table 4) represents chronic aggregate exposure.

Table 4.  Summary of Tier 1 Estimates of Exposure and Risk from Chronic Dietary Exposure to Acequinocyl

                                  Population
                                   Subgroup

                                  Chronic[1]

                               Dietary Exposure
                                  (mg/kg/day)

                                    % cPAD

Total U.S. Population
                                   0.003701
                                     13.7

All Infants (< 1 year)
                                   0.006237
                                     23.1

Non-Nursing Infants (< 1 year old)
                                   0.007788
                                     28.8

Children (1-2 years)
                                   0.015713
                                     58.2

Children (3-5 years)
                                   0.010992
                                     40.7

Females (13-49 years)
                                   0.002698
                                     10.0

Youths (13-19 years)
                                   0.002610
                                      9.7

Adults (20-49 years)
                                   0.002795
                                     10.4

Adults  (50+ years)
                                   0.002699
                                     10.0

[1]The chronic dietary cPAD of 0.027 mg/kg/day applies to the general U.S. population and all population subgroups.

2. Infants and children. The short-term aggregate risk calculations for the general U.S. population and children, 6 to 12 years old, are shown below in Table 3.  Both aggregate MOEs are greater than 100 and therefore are not of concern.

F. International Tolerances
Codex maximum residue levels (MRLs) are not yet established for acequinocyl.


[Federal Register Volume 78, Number 48 (Tuesday, March 12, 2013)]
[Notices]
[Page 15736]
[FR Doc No: 2013-05631]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4101-DR; Docket ID FEMA-2013-0001]

Mississippi; Amendment No. 5 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Mississippi (FEMA-4101-DR), dated February 13, 2013,
and related determinations.

DATES: Effective Date: March 4, 2013.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Mississippi is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of February 13, 2013.

    Greene and Perry Counties for Individual Assistance.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-05631 Filed 3-11-13; 8:45 am]
BILLING CODE 9111-23-P