[Federal Register: May 25, 2006 (Volume 71, Number 101)]
[Notices]
[Page 30209-30211]
[DOCID:fr25my06-117]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53838; File No. SR-NASD-2006-059]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change and Amendment No. 1 Thereto Related to Non-NASD
Member Broker/Dealer Access to Nasdaq's Brut and INET Facilities

May 18, 2006.
    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 May 1, 2006, the National Association of Securities Dealers, Inc.
(``NASD''), through its subsidiary, the Nasdaq Stock Market, Inc.
(``Nasdaq''), filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by Nasdaq. On May 16, 2006,
Nasdaq submitted Amendment No. 1 to the proposed rule change.\3\ Nasdaq
filed the proposed rule change, as amended, as a ``non-controversial''
rule change under Rule 19b-4(f)(6) under the Act,\4\ which renders the
proposal effective upon filing with the Commission. The Commission is
publishing this notice to solicit comments on the proposed rule change,
as amended, from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ In Amendment No. 1, the Exchange clarified in the purpose
section the number of non-member broker-dealers with access to the
Brut and INET systems. In addition, Nasdaq requested waivers of the
5-day notice and 30-day pre-operative delay contained in Rule 19b-
4(f)(6)(iii) under the Act.
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq proposes to continue the participation of broker-dealers
that are non-NASD members in Nasdaq's Brut and INET systems through the
earlier of July 1, 2006, or the date Nasdaq becomes operational as a
national securities exchange for the particular types of securities
traded by those non-members in Nasdaq's INET and Brut systems. Nasdaq
would implement the proposed rule change immediately. The text of the
proposed rule change is below. Proposed new language is in italics.
Proposed deletions are in [brackets].
4901. Definitions
    (a) through (h) No change.
    (i) The term ``Participant'' shall mean an NASD member that
fulfills the obligations contained in Rule 4902 regarding participation
in the System. [Until May 1, 2006] [t]The term ``Participant'' shall
also include non-NASD broker/dealers that desire to use the System and
otherwise meet all other requirements for System participation. Non-
NASD member broker/dealers shall have access to System until the
earlier of either July 1, 2006, or the date that Nasdaq becomes
operational as a national securities exchange for the particular class
of securities traded by the non-NASD member.
    (j) through (w) No Change
* * * * *
4952. System Participant Registration
    (a) Participation in INET requires current registration with the
System and is conditioned upon the Participant's

initial and continuing compliance with the following requirements:
    (1)-(5) No Change.
    (6) In addition to the above, [on or before May 1, 2006,] all
System Participants shall be members of the Association. Exception:
Non-NASD member broker/dealers shall have access to System until the
earlier of either July 1, 2006, or the date that Nasdaq becomes
operational as a national securities exchange for the particular class
of securities traded by the non-NASD member.
* * * * *

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, as
amended, and discussed any comments it received on the proposed rule
change, as amended. The text of these statements may be examined at the
places specified in Item IV below. Nasdaq 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, Proposed Rule Change

1. Purpose
    Nasdaq states that, under current rules, broker-dealers that are
not members of the NASD may use the Brut and INET systems until May 1,
2006. Nasdaq is proposing to modify this provision so as to allow non-
NASD member broker-dealers to use the Brut and INET systems until the
earlier of either July 1, 2006, or the date that Nasdaq becomes
operational as a national securities exchange for the particular class
of securities traded by the non-member. Nasdaq believes that this
division of dates upon which non-NASD members must be members of the
Nasdaq exchange in order to continue to use Nasdaq's trading facilities
is necessary because Nasdaq plans to become operational as an exchange
in two phases with the first involving only Nasdaq securities, with a
second later phase for securities listed by other exchanges. Under the
proposal, non-NASD members trading Nasdaq-listed securities would be
required to be a Nasdaq exchange member to continue to trade Nasdaq
securities in Brut and INET on the date that Nasdaq becomes operational
as exchange for Nasdaq issues, while entities trading other exchange-
listed securities would be allowed continued access to the Brut and
INET systems for that trading until such time as Nasdaq becomes
operational as an exchange for non-Nasdaq issues. Nasdaq states that in
neither scenario would non-NASD member access to the Brut and INET
systems extend beyond July 1, 2006 without a further Commission-
approved extension.
    Nasdaq states that this extension is intended to allow these non-
NASD member broker-dealers to have continued access to Brut and INET
while they take actions to become members of the recently-approved
Nasdaq exchange. Nasdaq notes that only 44 non-NASD member broker
dealers currently have access to its Brut and INET systems (4 in the
Brut system and 40 in the INET system) and, as before, Nasdaq commits
not to allow any additional non-NASD broker-dealers access during this
extension period.\5\
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    \5\ See Amendment No. 1, supra note 3.
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2. Statutory Basis
    Nasdaq believes that the proposed rule change, as amended, is
consistent with the provisions of Section 15A of the Act,\6\ in
general, and with Section 15A(b)(5) of the Act,\7\ in particular, in
that it is designed to promote just and equitable principles of trade,
and to remove impediments to a free and open market and a national
market system.
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    \6\ 15 U.S.C. 78o-3.
    \7\ 15 U.S.C. 78o-3(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change, as amended,
will result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act.

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

    Nasdaq states that written comments were neither solicited nor
received with respect to the proposed rule change, as amended.

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

    Because the proposed rule change, as amended, does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of filing (or such shorter
time as the Commission may designate if consistent with the protection
of investors and the public interest), the proposed rule change, as
amended, has become effective pursuant to Section 19(b)(3)(A) of the
Act \8\ and subparagraph (f)(6) of Rule 19b-4 thereunder.\9\
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under 19b-4(f)(6) normally may not
become operative prior to 30 days after the date of filing.\10\
However, Rule 19b-4(f)(6)(iii) \11\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest. Nasdaq has requested that the
Commission waive the 30-day pre-operative delay and the five-day pre-
filing notice requirement and designate the proposed rule change, as
amended, to become effective upon filing. Nasdaq believes that waivers
of such periods will allow continued uninterrupted access to the Brut
and INET systems for non-NASD broker dealers in the period of time
immediately preceding Nasdaq's operation as an exchange. The Commission
believes that waiving the 30-day pre-operative delay and the five-day
pre-filing notice requirement is consistent with the protection of
investors and the public interest because it would facilitate the
orderly transition of Nasdaq to a national securities exchange, thus
removing impediments to a free and open market and a national market
system. For the reasons stated above, the Commission designates the
proposal, as amended, to become effective and operative on May 1,
2006.\12\
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    \10\ 17 CFR 240.19b-4(f)(6)(iii).
    \11\ Id.
    \12\ For purposes only of accelerating the operative date of
this proposal, the Commission has considered the impact of the
proposed rule on efficiency, competition, and capital formation. 15
U.S.C. 78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in the furtherance of the purposes of the Act.\13\
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    \13\ The effective date of the original proposed rule change is
May 1, 2006, and the effective date of Amendment No. 1 is May 16,
2006. For purposes of calculating the 60-day period within which the
Commission may summarily abrogate the proposal, the Commission
considers the period to commence on May 16, 2006, the date on which
the Exchange submitted Amendment No. 1.

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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASD-2006-059 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASD-2006-059. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549. Copies of such filing also will be available
for inspection and copying at the principal office of Nasdaq. 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-NASD-2006-059 and should be
submitted on or before June 15, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
[FR Doc. E6-7996 Filed 5-24-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 88, Number 155 (Monday, August 14, 2023)]
[Proposed Rules]
[Pages 54949-54952]
[FR Doc No: 2023-17017]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-1709; Project Identifier MCAI-2022-01642-T]
RIN 2120-AA64

Airworthiness Directives; Airbus Canada Limited Partnership (Type
Certificate Previously Held by C Series Aircraft Limited Partnership
(CSALP); Bombardier, Inc.) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-
500-1A11 airplanes. This proposed AD was prompted by reports of
mechanical wear damage on the motive flow fuel-feed tubes that were
secured by bonding clamps and clamp blocks inside the collector tank.
This proposed AD would require repetitive operational checks of the
gravity cross flow shut-off valve and, for certain airplanes, a one-
time inspection of the motive flow fuel-feed tubes at the clamp blocks
location, and corrective action if necessary, as specified in a
Transport Canada AD, which is proposed for incorporation by reference
(IBR). 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 September
28, 2023.

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 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.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-1709; 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 mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For material that is proposed for IBR in this NPRM,
contact Transport Canada, Transport Canada National Aircraft
Certification, 159 Cleopatra Drive, Nepean, Ontario K1A 0N5, Canada;
telephone<PHONE_NUMBER>; email: [email protected]; website: tc.canada.ca/en/aviation.
It is also available at regulations.gov under Docket No. FAA-2023-1709.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th Street, Des Moines, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Joseph Catanzaro, Aviation Safety
Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; email [email protected].

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-2023-1709; Project Identifier
MCAI-2022-01642-T'' 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
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
Joseph Catanzaro, Aviation Safety Engineer, FAA, 1600 Stewart Avenue,
Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>; email
[email protected]. Any commentary that the FAA receives which is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Background

    Transport Canada, which is the aviation authority for Canada, has
issued Transport Canada AD CF-2022-70, dated December 21, 2022
(Transport Canada AD CF-2022-70) (also referred to as the MCAI), to
correct an unsafe condition for certain Airbus Canada Limited
Partnership (Type Certificate previously held by C Series Aircraft
Limited Partnership (CSALP); Bombardier, Inc.) Model BD-500-1A10 and
BD-500-1A11 airplanes. The MCAI states there have been several findings
of mechanical wear damage on the motive flow fuel-feed tubes that were
secured by bonding clamps and clamp blocks inside the collector tank.
In some instances, the wear damage led to a hole in a motive flow fuel-
feed tube resulting in a fuel imbalance during flight that required the
flightcrews to correct the imbalance using the gravity transfer system.
Failure of the affected motive flow fuel-feed tubes and a subsequent
failure of the gravity transfer system could lead to a fuel imbalance
condition resulting in a reduction in airplane functional capabilities
and increased crew workload.
    The FAA is proposing this AD to address the unsafe condition on
these products. You may examine the MCAI in the AD docket at
regulations.gov under Docket No. FAA-2023-1709.

Related Service Information Under 1 CFR Part 51

    Transport Canada AD CF-2022-70 specifies procedures for performing
a repetitive operational check of the gravity cross flow shut-off valve
and, for certain airplanes, inspecting the motive flow fuel-feed tubes
for mechanical wear damage (damage includes cracks, scores, scratches,
nicks, and gouges) and pre-load condition, and, based on findings,
replacing the motive flow fuel-feed tube.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in ADDRESSES section.

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
referenced above. The FAA is issuing this NPRM after determining that
the unsafe condition described previously is likely to exist or develop
in other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in Transport Canada AD CF-2022-70 described previously, except for any
differences identified as exceptions in the regulatory text of this
proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate Transport Canada AD CF-

2022-70 by reference in the FAA final rule. This proposed AD would,
therefore, require compliance with Transport Canada AD CF-2022-70 in
its entirety through that incorporation, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Service information required by Transport Canada AD CF-2022-70 for
compliance will be available at regulations.gov under Docket No. FAA-
2023-1709 after the FAA final rule is published.

Interim Action

    The FAA considers that this proposed AD would be an interim action.
If final action is later identified, the FAA might consider further
rulemaking then.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 84 airplanes of U.S. registry. The FAA estimates the following
costs to comply with this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
               Labor cost                   Parts cost         Cost per  product        Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Up to 16.5 work-hours x $85 per hour =               $0   Up to $1,403..............  Up to $117,810.
 $1,403.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition action that would be required based on the results of any
required actions. The FAA has no way of determining the number of
aircraft that might need this on-condition action:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
          Labor cost                 Parts cost       Cost per  product
------------------------------------------------------------------------
12 work-hours x $85 per hour =              $5,256               $6,276
 $1,020.......................
------------------------------------------------------------------------

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some or all 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:

Airbus Canada Limited Partnership (Type Certificate Previously Held
by C Series Aircraft Limited Partnership (CSALP); Bombardier, Inc.):
Docket No. FAA-2023-1709; Project Identifier MCAI-2022-01642-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by September 28, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Canada Limited Partnership (Type
Certificate previously held by C Series Aircraft Limited Partnership
(CSALP); Bombardier, Inc.) Model BD-500-1A10 and BD-500-1A11
airplanes, certificated in any category, as identified in Transport
Canada AD CF-2022-70, dated December 21, 2022 (Transport Canada AD
CF-2022-70).

(d) Subject

    Air Transport Association (ATA) of America Code: 28, Fuel.

(e) Unsafe Condition

    This AD was prompted by reports of mechanical wear damage on the
motive flow fuel-feed tubes that were secured by bonding clamps and
clamp blocks inside the collector tank. The FAA is issuing this AD
to address mechanical wear damage on the motive flow fuel-feed
tubes. Failure of the affected motive flow fuel-feed tubes and a
subsequent failure of the gravity transfer system could lead to a
fuel imbalance condition resulting in a reduction in airplane
functional capabilities and increased crew workload.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, Transport Canada AD CF-2022-70.

(h) Exceptions to Transport Canada AD CF-2022-70

    (1) Where Transport Canada AD CF-2022-70 refers to its effective
date, this AD requires using the effective date of this AD.
    (2) Where Transport Canada AD CF-2022-70 refers to hours air
time, this AD requires using flight hours.
    (3) Where Part II of Transport Canada AD CF-2022-70 specifies to
inspect the motive flow fuel-feed tubes, and ``rectify as
required,'' this AD requires accomplishment of all corrective
actions before further flight.

(i) No Reporting Requirement

    Although the service information referenced in Transport Canada
AD CF-2022-70 specifies to submit certain information to the
manufacturer, this AD does not include that requirement.

(j) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Validation Branch, FAA, 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 responsible Flight Standards Office, as
appropriate. If sending information directly to the manager of the
International Validation Branch, mail it to ATTN: Program Manager,
Continuing Operational Safety, at the address identified in
paragraph (k) of this AD or email to: [email protected]. If
mailing information, also submit information by email. Before using
any approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the responsible Flight
Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Validation Branch, FAA; or Transport Canada; or Airbus Canada
Limited Partnership (Type Certificate Previously Held by C Series
Aircraft Limited Partnership (CSALP); Bombardier, Inc.)'s Transport
Canada Design Approval Organization (DAO). If approved by the DAO,
the approval must include the DAO-authorized signature.

(k) Additional Information

    For more information about this AD, contact Joseph Catanzaro,
Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; email
[email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Transport Canada AD CF-2022-70, dated December 21, 2022.
    (ii) [Reserved]
    (3) For Transport Canada AD CF-2022-70, contact Transport
Canada, Transport Canada National Aircraft Certification, 159
Cleopatra Drive, Nepean, Ontario K1A 0N5, Canada; telephone 888-663-
3639; email: [email protected]; website: tc.canada.ca/en/
aviation.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th Street, Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on August 3, 2023.
Victor Wicklund,
Deputy Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-17017 Filed 8-11-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 218 (Thursday, November 10, 2011)]
[Notices]
[Pages 70206-70207]
[FR Doc No: 2011-29163]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65699; File No. SR-ICC-2011-03]

Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of
Filing of Proposed Rule Change to Adopt ICC's Enhanced Margin
Methodology (the ``Decomp Model'')

November 7, 2011.
    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 November 4, 2011, ICE Clear Credit LLC (``ICC'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change as described in Items I, II, and III below, which Items have
been prepared primarily by ICC. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

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

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

    The ICC Decomp Model includes the following enhancements to the ICC
margin methodology for Credit Default Swap (``CDS'') Indices: replacing
standard deviation with Mean Absolute deviation (``MAD'') as a measure
of spread volatility, use of an auto regressive process to obtain
multi-horizon risk measures, expansion of spread response scenarios,
introduction of liquidity requirements, and base concentration charges.

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

    In its filing with the Commission, ICC 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. ICC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\3\
---------------------------------------------------------------------------

    \3\ The Commission has modified the text of the summaries
prepared by ICC.
---------------------------------------------------------------------------

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

    The enhancements effected by this proposed rule change have been
reviewed and/or recommended by the ICC Risk Working Group, ICC Risk
Committee, ICC Board of Managers, an independent third-party risk
expert (Finance Concepts), the Federal Reserve Bank of New York and the
New York State Banking Department. Implementation of these enhancements
to the ICC risk methodology will result in a better measurement of the
risk associated with clearing CDS Indices.
    A fundamental aspect of the Decomp Model is the recognition that
the CDS Indices cleared by ICC are essentially a composition of
specific Single Name CDS instruments. As a result of the decomposition
of the CDS Indices, ICC will be able to (1) incorporate jump-to-default
risk as a component of the risk margin associated with CDS Indices and
(2) provide appropriate portfolio margin treatment between CDS Indices
and offsetting CDS Single Name positions.
    Incorporating jump-to-default risk as a component of the Decomp
Model will result in a better measurement of the risk associated with
clearing CDS Indices.
    Recognizing the highly correlated relationship between long-short
positions in CDS Indices and the underlying CDS Single Name
constituents of the CDS Indices will provide for fundamental and
appropriate portfolio margin treatment. To date, ICC has not offered
such fundamental and appropriate portfolio treatment strictly for
operational reasons. However, on or about December 12, 2011, ICC will
be operationally ready to offer such portfolio margining treatment with
respect to its clearing participants' proprietary positions.
    As noted above, the proposed change in the ICC margin methodology
will provide appropriate portfolio margining treatment only with
respect to ICC clearing participants' proprietary positions. The
portfolio margining treatment will only be available to ICC clearing
participants' proprietary positions because ICC does not currently
clear CDS Single Names for customer-related transactions. Accordingly,
currently, there are no customer-related positions that would qualify
for portfolio margining treatment. ICC does not believe that the fact
that the portfolio margining element of the proposed Decomp Model will
apply only to a Clearing Participant's proprietary account raises an
issue of unfair discrimination. Importantly, the portfolio margining
aspect of the Decomp Model does not unfairly discriminate with respect
to similarly situated participants because it is available to any
participant for whom ICC is currently able to provide portfolio margin
treatment. Again, ICC does not currently offer clearing in CDS Single
Names for customer-related transactions. In the event that ICC makes
CDS Single Name clearing available for customer-related transactions
and provided that the SEC and CFTC grant the requisite approval as
discussed below, ICC will offer portfolio margining with respect to
customer-related transactions. The proposed rule amendments are not
designed to permit unfair discrimination among participants in the use
of ICC's clearing services. ICC is not discriminating among proprietary
participants or among customers. Proprietary accounts are not subject
to the SEC's customer protection rules and thus are not subject to the
same restrictions that the SEC has imposed on customer accounts.
Specifically, ICC clears proprietary CDS Index and CDS Single Name
positions in the same commingled house account origin. Whereas, as
customer-related positions in CDS Indices and CDS Single Names must be
maintained, as a matter of law, in separate accounts. Thus, ICC is
unable to commingle and portfolio margin customer-related CDS Index and
CDS Single Name positions without the SEC's and CFTC's approval of
ICC's pending petitions.
    On or about November 7, 2011, ICC formally filed with the SEC a
petition to provide portfolio margining treatment for customer-related
positions (the ``Customer-related Portfolio Margining Request'') in
anticipation of ICC offering clearing of CDS Single Names for customer-
related transactions in the future. The Customer-related Portfolio
Margining Request is posted on the ICC Web site and will be posted on
the SEC's Web site.\4\ In short, the Customer-related Portfolio
Margining Request, if granted by the SEC, would provide all customers
with the same portfolio margining treatment that is being

proposed in this submission for the proprietary accounts. However, in
order to obtain portfolio margining treatment for customers, ICC was
required to file the separate Customer-related Portfolio Margining
Request. Although the SEC has not published ICC's Customer-related
Portfolio Margining Request for public comment, the SEC is interested
in receiving comments from the public.
---------------------------------------------------------------------------

    \4\ Available at: https://www.theice.com/publicdocs/globalmarketfacts/docs/legislativecomments/ICC_Commingling_PortfolioMargining_Petitions.pdf. The petition also will be
available on the Commission's public Web site at: http://www.sec.gov/rules/petitions.shtml.
---------------------------------------------------------------------------

    ICC believes that the proposed rule change will facilitate the
prompt and accurate settlement of security-based swaps and contribute
to the safeguarding of securities and funds associated with security-
based swap transactions. As discussed above, ICC does not believe that
the portfolio margining-related proposed changes raise an issue of
unfair discrimination in the use of ICC's clearing services by
similarly situated participants.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    ICC does not believe the proposed rule change would have any
impact, or impose any burden, on competition.

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

    Written comments relating to the proposed rule change have not been
solicited or received. ICC will notify the Commission of any written
comments received by ICC.

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-ICC-2011-03 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ICC-2011-03. 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 Section, 100 F Street
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filings will also be available for
inspection and copying at the principal office of ICC and on ICC's Web
site at https://www.theice.com/publicdocs/regulatory_filings/ICEClearCredit_110411.pdf.
    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-ICC-2011-03
and should be submitted on or before December 1, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\5\
---------------------------------------------------------------------------

    \5\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-29163 Filed 11-9-11; 8:45 am]
BILLING CODE P


[Federal Register Volume 87, Number 83 (Friday, April 29, 2022)]
[Proposed Rules]
[Pages 25432-25433]
[FR Doc No: 2022-09232]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2022-D-0370]

The Accredited Third-Party Certification Program: Questions and
Answers; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``The Accredited Third-Party Certification Program: Questions and
Answers.'' The draft guidance, when finalized, will answer frequently
asked questions relating to the requirements of the Accredited Third-
Party Certification Program, and is intended to assist accreditation
bodies', third-party certification bodies', and eligible entities'
understanding of the regulation and program requirements.

DATES: Submit either electronic or written comments on the draft
guidance by July 28, 2022 to ensure that the Agency considers your
comment on the draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-0370 for ``The Accredited Third-Party Certification Program:
Questions and Answers.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Doriliz De Leon, Center for Food
Safety and Applied Nutrition (HFS-607), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry
entitled ``The Accredited Third-Party Certification Program: Questions
and Answers.'' We are issuing the draft guidance consistent with our
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on this
topic. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternate approach if it
satisfies the requirements of the applicable statutes and regulations.
    The FDA Food Safety Modernization Act (Pub. L. 111-353) added
section 808 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 384d), which directs FDA to establish a program for
accreditation of third-party certification bodies to conduct food
safety audits and to certify that eligible foreign food entities
(including registered foreign food facilities) and food produced by
such entities meet applicable FDA requirements for purposes of sections
801(q) (21 U.S.C. 381(q)) and 806 (21 U.S.C. 384b) of the FD&C Act. On
November 27, 2015, FDA issued the final rule, ``Accreditation of Third-
Party Certification Bodies to Conduct Food Safety Audits and to Issue
Certifications'' (also referred to as the TPP regulation) (80 FR 74569;
21 CFR part 1, subpart M). This draft guidance,

when finalized, will answer frequently asked questions relating to the
requirements of the Accredited Third-Party Certification Program
established in 21 CFR part 1, subpart M (21 CFR 1.600 through 1.695, 21
CFR 1.700 through 1.725), and is intended to assist the accreditation
bodies', third-party certification bodies', and eligible entities'
understanding of the TPP regulation and program requirements.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required. The previously approved collections of information are
subject to review by OMB under the PRA. The collections of information
under the TPP regulation in 21 CFR part 1, subpart M have been approved
under OMB control number 0910-0750.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.regulations.gov. Use the FDA website
listed in the previous sentence to find the most current version of the
guidance.

    Dated: April 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09232 Filed 4-28-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Rules and Regulations]
[Pages 87666-87668]
[FR Doc No: 2023-27826]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31522; Amdt. No. 4092]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule amends, suspends, or removes Standard Instrument
Approach Procedures (SIAPs) and associated Takeoff Minimums and
Obstacle Departure Procedures for operations at certain airports. These
regulatory actions are needed because of the adoption of new or revised
criteria, or because of changes occurring in the National Airspace
System, such as the commissioning of new navigational facilities,
adding new obstacles, or changing air traffic requirements. These
changes are designed to provide for the safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective December 19, 2023. The compliance date
for each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of December 19, 2023.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001;
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Information Services, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA).

    For information on the availability of this material at NARA, visit
www.archives.gov/federal-register/cfr/ibr-locations or email
[email protected].

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center online at nfdc.faa.gov
to register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedures
and Airspace Group, Flight Technologies and Procedures Division, Flight
Standards Service, Federal Aviation Administration. Mailing Address:
FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace
Group, 6500 South MacArthur Blvd., STB Annex, Bldg. 26, Room 217,
Oklahoma City, OK 73099. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends 14 CFR part 97 by amending
the referenced SIAPs. The complete regulatory description of each SIAP
is listed on the appropriate FAA Form 8260, as modified by the National
Flight Data Center (NFDC)/Permanent Notice to Air Missions (P-NOTAM),
and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51,
and 14 CFR 97.20. The large number of SIAPs, their complex nature, and
the need for a special format make their verbatim publication in the
Federal Register expensive and impractical. Further, pilots do not use
the regulatory text of the SIAPs, but refer to their graphic depiction
on charts printed by publishers of aeronautical materials. Thus, the
advantages of incorporation by reference are realized and publication
of the complete description of each SIAP contained on FAA form
documents is unnecessary. This amendment provides the affected CFR
sections, and specifies the SIAPs and Takeoff Minimums and ODPs with
their applicable effective dates. This amendment also identifies the
airport and its location, the procedure and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPs, Takeoff
Minimums and ODPs as identified in the amendatory language for part 97
of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP and Takeoff Minimums and ODP as amended in the
transmittal. For safety and timeliness of change considerations, this
amendment incorporates only specific changes contained for each SIAP
and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
    The SIAPs and Takeoff Minimums and ODPs, as modified by FDC
permanent NOTAM, and contained in this amendment are based on criteria
contained in the U.S. Standard for Terminal Instrument Procedures
(TERPS). In developing these changes to SIAPs and Takeoff Minimums and
ODPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts.
    The circumstances that created the need for these SIAP and Takeoff
Minimums and ODP amendments require making them effective in less than
30 days.
    Because of the close and immediate relationship between these
SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find
that notice and public procedure under 5 U.S.C. 553(b) are
impracticable and contrary to the public interest and, where
applicable, under 5 U.S.C. 553(d), good cause exists for making these
SIAPs effective in less than 30 days.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference,
Navigation (Air).

    Issued in Washington, DC, on December 8, 2023.
Thomas J. Nichols,
Manager, Aviation Safety, Flight Standards Service, Standards Section,
Flight Procedures & Airspace Group, Flight Technologies & Procedures
Division.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, 14 CFR part
97 is amended by amending Standard Instrument Approach Procedures and
Takeoff Minimums and ODPs, effective at 0901 UTC on the dates
specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114,
40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

--------------------------------------------------------------------------------------------------------------------------------------------------------
        AIRAC date            State             City             Airport name       FDC No.      FDC date                  Procedure name
--------------------------------------------------------------------------------------------------------------------------------------------------------
25-Jan-24................  IL           Chicago............  Chicago Midway Intl       3/0014     10/24/23  RNAV (GPS) Z RWY 22L, Amdt 2A.
25-Jan-24................  IL           Chicago............  Chicago O'Hare Intl       3/0415     11/14/23  RNAV (GPS) PRM RWY 10C (CLOSE PARALLEL),
                                                                                Orig-A.
25-Jan-24................  IL           Chicago............  Chicago O'Hare Intl       3/0417     11/14/23  RNAV (GPS) RWY 10C, Amdt 1A.
25-Jan-24................  GU           Guam...............  Guam Intl..........       3/1233     10/17/23  RNAV (RNP) Z RWY 6R, Orig-C.

25-Jan-24................  GU           Guam...............  Guam Intl..........       3/1623     10/17/23  RNAV (RNP) Z RWY 6L, Orig-D.
25-Jan-24................  TX           Weslaco............  Mid Valley.........       3/1772     10/26/23  VOR-A, Orig-B.
25-Jan-24................  VA           Roanoke............  Roanoke/Blacksburg        3/3252     11/20/23  LDA Z RWY 6, Orig.
                                                              Rgnl (Woodrum Fld).
25-Jan-24................  VA           Roanoke............  Roanoke/Blacksburg        3/3255     11/20/23  RNAV (RNP) Z RWY 24, Orig.
                                                              Rgnl (Woodrum Fld).
25-Jan-24................  VA           Roanoke............  Roanoke/Blacksburg        3/3639     11/20/23  RNAV (RNP) Z RWY 6, Orig.
                                                              Rgnl (Woodrum Fld).
25-Jan-24................  SC           Summerville........  Summerville........       3/3863     10/12/23  RNAV (GPS) RWY 24, Orig-C.
25-Jan-24................  CA           Mountain View......  Moffett Federal           3/4042      11/9/23  ILS OR LOC RWY 32R, Amdt 2.
                                                              Airfield.
25-Jan-24................  FL           Fort Lauderdale....  Fort Lauderdale/          3/4077      11/2/23  RNAV (GPS) Y RWY 28R, Amdt 5.
                                                              Hollywood Intl.
25-Jan-24................  SD           Aberdeen...........  Aberdeen Rgnl......       3/4485     11/21/23  RNAV (GPS) RWY 35, Amdt 1.
25-Jan-24................  SD           Aberdeen...........  Aberdeen Rgnl......       3/4487     11/21/23  RNAV (GPS) RWY 31, Orig-B.
25-Jan-24................  KS           Norton.............  Norton Muni........       3/5231      9/29/23  RNAV (GPS) RWY 16, Amdt 1B.
25-Jan-24................  PA           Harrisburg.........  Harrisburg Intl....       3/5232     10/23/23  RNAV (GPS) RWY 31, Amdt 1A.
25-Jan-24................  MO           Higginsville.......  Higginsville              3/5990     10/13/23  RNAV (GPS) RWY 34, Amdt 1.
                                                              Industrial Muni.
25-Jan-24................  MO           Higginsville.......  Higginsville              3/5993     10/13/23  RNAV (GPS) RWY 16, Amdt 1.
                                                              Industrial Muni.
25-Jan-24................  FL           Panama City........  Northwest Florida         3/6411     10/27/23  ILS OR LOC RWY 16, ILS RWY 16 (SA CAT I),
                                                              Beaches Intl.                                  ILS RWY 16 (SA CAT II), Amdt 3A.
25-Jan-24................  MI           Lansing............  Capital Region Intl       3/7469     10/18/23  ILS OR LOC RWY 28L, Amdt 28A.
25-Jan-24................  FL           Orlando............  Orlando Intl.......       3/8059      10/5/23  RNAV (GPS) RWY 17R, Orig-D.
25-Jan-24................  FL           Orlando............  Orlando Intl.......       3/8060      10/5/23  RNAV (GPS) RWY 35L, Amdt 1A.
25-Jan-24................  AK           Cordova............  Merle K (Mudhole)         3/8167      11/6/23  RNAV (GPS)-B, Amdt 2B.
                                                              Smith.
25-Jan-24................  FL           West Palm Beach....  Palm Beach Intl....       3/8298     10/20/23  RNAV (GPS) Y RWY 14, Amdt 4.
25-Jan-24................  CA           Mountain View......  Moffett Federal           3/8470      11/9/23  RNAV (GPS) RWY 32L, Amdt 1.
                                                              Airfield.
25-Jan-24................  NY           Malone.............  Malone-Dufort......       3/9901      10/5/23  RNAV (GPS) RWY 23, Orig-D.
25-Jan-24................  KY           Henderson..........  Henderson City-           3/9903      10/6/23  RNAV (GPS) RWY 9, Amdt 1A.
                                                              County.
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[FR Doc. 2023-27826 Filed 12-18-23; 8:45 am]
BILLING CODE 4910-13-P


OVERVIEW OF PRONAMIDE (Propyzamide) RISK ASSESSMENT Introduction The Agency has completed its review of the available data for the herbicide pronamide and is announcing its tolerance reassessment decision. This document summarizes EPA's human health findings and conclusions as presented fully in the documents entitled "Pronamide Tolerance Reassessment Eligibility Decision (TRED)" dated March 8, 2002, "Pronamide Revised Aggregate Risk Estimates Addendum to EPA March 8, 2002" dated May 21, 2002 and related documents supporting this decision. The purpose of this overview is to assist the reader by identifying the key features and findings of the risk assessment in order to enhance understanding of the conclusions reached in the tolerance reassessment decision. The Agency's reassessment of aggregate risk, including exposure through food, drinking water, and residential exposure is required by the Federal Food, Drug, and Cosmetic Act (FFDCA). The Agency must review tolerances and tolerance exemptions that were in effect when the Food Quality Protection Act (FQPA) was enacted in August 1996 to ensure that these existing pesticide residue limits for food and feed commodities meet the safety standard of the new law.

FFDCA requires the Agency to review all the tolerances for registered chemicals in effect on or before the date of the enactment of FQPA. In reviewing these tolerances, the Agency must consider, among other things, aggregate risks from non occupational sources of pesticide exposure, whether there is increased susceptibility to infants and children, and the cumulative effects of pesticides with a common mechanism of toxicity. The tolerances are considered reassessed once the safety finding has been made or a tolerance revocation occurs. A RED for pronamide was issued in May 1994, prior to enactment of FQPA; therefore it needed to be updated to consider the provisions of the Act.

FQPA requires that the Agency, when considering whether to establish, modify, or revoke a tolerance, consider "available information" concerning the cumulative effects of the particular pesticide's residues and "other substances that have a common mechanism of toxicity." The Agency does not, at this time, have sufficient reliable information available to determine whether pronamide has a common mechanism of toxicity with other substances. Therefore, for the purposes of this risk assessment, the Agency has not assumed that pronamide has a common mechanism of toxicity with other substances. If EPA identifies other substances that share a common mechanism of toxicity with pronamide, a cumulative risk assessment for those substances will be performed.

The risk assessment and documents pertaining to the Agency's report on FQPA tolerance reassessment progress and risk management decision for pronamide are available on the Internet at http:// www. epa. gov/ pesticides/ reregistration/ status. htm and in the public docket. The Agency's report on FQPA tolerance reassessment progress and risk management decision for pronamide will be announced in the Federal Register. 2 Use Profile Herbicide: Pronamide is a selective, pre emergence herbicide registered for the control of grassy and broadleaf weeds on terrestrial food crops [artichoke, blackberry, blueberry, boysenberry, cherry, endive (escarole), lettuce, nectarine, peach, pear, plum, prune, raspberry, (black, red), rhubarb]; terrestrial food and feed crops (agricultural fallow/ idleland, apples, grapes, peas, sugar beets); terrestrial non food crops (Christmas trees, clover plantations, golf course turf, ornamental herbaceous plants, recreation area lawns) and outdoor residential areas (ornamental and/ or shade trees, ornamental woody shrubs and vines).

Formulations: Wettable powder 50% and 51% active ingredient (a. i.) and technical grade 92% a. i.

Methods and Rates of Application: Pronamide is produced and formulated for use as a 50 WP wettable powder which is packaged in water soluble pouches and then mixed in water before application. Pronamide is applied as a liquid spray. It is a soil active systemic herbicide with uptake by susceptible weeds occurring through the roots. Application rates range from 0.5 to 4 lbs a. i. per acre per application per year. Most crop sites have only one application per year. However, artichokes have 2 applications per year (at 2 lbs per application) and gladiolas have 4 applications per year (at 2 lbs per application, up to 8 lbs a. i. per acre per application could be applied). It is applied to various food/ feed crops using ground spray equipment, by hand held sprayer, soil incorporation, or by aircraft.

Use Summary: Based on available pesticide usage data for 1991 through 2001, total annual domestic usage of pronamide is approximately 225,000 pounds. In terms of pounds a. i., total usage is allocated mainly to head lettuce (29%), other lettuce (19%), seed crops (13%), fallow land (11%), hay (other than alfalfa) (8%), horticulture (3%) and alfalfa (3%). Sites with 5% or more of acreage treated include lettuce (other than head) (49%), head lettuce (36%), California endive/ escarole (31%), artichokes (21%), blackberries (6%) and raspberries (5%). States with significant usage in terms of pound a. i. include Arizona, California, Oregon and Washington. Pre harvest intervals, where specified, are generally long, ranging from 25 to 180 days.

Classification: Pronamide is a restricted use pesticide.

Registrant: Dow AgroSciences (recently purchased from Rohm and Haas). 3 Human Health Risk Assessment Acute Dietary (Food) Risk (For a complete discussion, see section 4.2 of the Human Health Risk Assessment)

No toxicologic endpoint was identified as appropriate from a single (acute) dose of pronamide. Consequently an acute dietary risk assessment was not performed for pronamide.

Chronic Dietary (Food) Risk (For a complete discussion, see section 4.2 of the Human Health Risk Assessment Chronic dietary risk is calculated by using the average consumption value for food and average residue values on those foods over a 70 year lifetime. A risk estimate that is less than 100% of the chronic population adjusted dose (cPAD) (the dose at which an individual could be exposed over the course of a lifetime and no adverse health effects would be expected) is not of concern. The cPAD is the chronic reference dose (cRfD) adjusted for the FQPA Safety Factor.

The assessment showed that the chronic dietary risk estimates are not of concern, <1% of the cPAD, for the U. S. population and for all subgroups.

° The toxicity endpoint for the chronic dietary assessment is based on increased relative liver weight and non neoplastic histological changes in the liver, thyroid, and ovaries in a combined chronic toxicity/ carcinogenicity study in the rat. The no observable adverse effect level (NOAEL) is 8.46 mg/ kg/ day. The lowest observed adverse effect level (LOAEL) is 42.6 mg/ kg/ day.

° The Uncertainty Factor (UF) is 100X; 10X for intraspecies variation and 10X for interspecies extrapolation.

° The 10x FQPA Safety Factor was reduced to 3x for the following reasons:

1. The toxicological database is adequate for FQPA assessment. 2. There was no quantitative or qualitative evidence of increased susceptibility of rabbits to in utero exposure or to rats following pre/ postnatal exposure. Although the developmental toxicity study, was unacceptable because a definitive NOAEL as well as a LOAEL were not established, no increased susceptibility was seen at the highest dose tested. 3. A developmental neurotoxicity study is not required. 4. The dietary (food and drinking water) and residential exposure assessments will not underestimate the potential exposures for infants and children. 5. A 3x was retained because of evidence of endocrine organ toxicity in the thyroid, testes, ovaries, adrenal glands, pituitary gland, thymus. 4 For a more complete discussion see the December 3, 2001 FQPA Safety Factor Committee report and section 5.6 of the Pronamide (Propyzamide): Report of the Hazard Identification Assessment Review Committee (HIARC) Meeting for the Herbicide, Pronamide.

° The Dietary Exposure Evaluation Model (DEEM) was used to estimate chronic dietary exposure. A refined Tier 3 analysis was performed using: 1) percent crop treated; 2) anticipated residues for meat, milk, poultry and eggs; 3) FDA and PDP monitoring data; and, 4) tolerance level residues for 4 crops.

° The cPAD is 0.03 mg/ kg/ day (chronic RfD 0.08 mg/ kg/ day ÷ 3x FQPA safety factor).

Cancer Dietary Risk (Food)

(For a complete discussion, see section 4.2 of the Human Health Risk Assessment)

The cancer risk is calculated by using the average consumption value for food and average residue values on those foods over a 70 year lifetime. The chronic exposure value is typically combined with a linear, low dose approach (Q1 ( ) to determine the lifetime (cancer) risk estimate. The Agency generally considers risks greater than 1x10 6 (i. e., greater than one in a million) not of concern.

° Pronamide was previously classified as a Group B2 chemical, probable human carcinogen, based on thyroid follicular cell adenomas (males and females) and benign testicular interstitial cell tumors (males) in rats and hepatocellular carcinomas in male mice.

° A linear, low dose approach (Q1 ( ) is used for human risk characterization. The cancer potency unit risk (Q1 ( ) based on male mouse liver adenoma and/ or carcinoma combined tumor rates is 2.59x10 2 (mg/ kg/ day) 1 in human equivalents [converted from animals to humans by use of the (mg/ kg body weight) ¾ interspecies scaling factor].

° The cancer food risk estimate is 1.06x10 7 for the U. S. population, and does not exceed the Agency's level of concern (1.0x10 6 or one in one million).

Residential Risk (For a complete discussion, see section 4.4 of the Human Health Risk Assessment)

As a result of risk concerns for children identified in the March 8, 2002 risk assessment, the registrant agreed to voluntarily cancel a product labeled for the residential use (EPA Reg. No. 8660 85; see 67 FR 13627). Additionally, the registrant agreed to further limit use to turf grown for seed or sod and non residential sites including golf courses, industrial and office building sites, stadium fields or professional athletic fields. These risk mitigation measures 5 make children's non dietary exposure unlikely. To minimize adult residential exposure related to the sites listed above, the registrant has agreed to amend pronamide labels to require 24 hour restricted entry interval or require watering in as soon as possible after application.

Given these proposed restrictions on the use of pronamide on turf, high contact dermal scenarios are not likely to occur. Therefore, the sole exposure scenario for the residential risk assessment is based on low contact activity which is represented and estimated by golf course reentry. The route of exposure is dermal. The population at risk is adults.

The dermal exposure estimates are considered somewhat refined, since turf transferrable residue (TTR) data from a pronamide TTR field study was used. However, both the short term exposure estimates and the cancer risk estimates relied on a 100% dermal absorption factor, which results in high end dose estimates. Therefore, a dermal absorption study would help to reduce these risk estimates.

A 3x FQPA Safety Factor is required for all population subgroups when assessing residential exposures of all durations. The rationale for reducing the safety factor is the same as listed under the chronic dietary risk discussion.

Short Term C For short term (1 30) incidental oral exposures an adjusted dose of 8.46 mg/ kg/ day was established for use in the risk assessment. This dose is derived from the NOAEL from a chronic toxicity/ carcinogenicity study in rats, where the effects are increased liver weight and non neoplastic histologic changes in the liver, thyroid, and ovaries observed at the LOAEL of 42.6 mg/ kg/ day. The dose selection is based on a maternal toxicity NOAEL of 5 mg/ kg/ day and clinical signs of toxicity (soiled anal area and anorexia) and liver effect (punctate vacuolation of hepatocytes) observed at the LOAEL of 20 mg/ kg/ day in the developmental toxicity study conducted in rabbits. Although this study is of the appropriate route (oral) and duration (13 days), the NOAEL (5 mg/ kg/ day) in this study is lower than the NOAEL (8.46 mg/ kg/ day) established in the chronic toxicity/ carcinogenicity study in the rat. The apparent disparity between these NOAELs is driven by the doses of pronamide selected for testing in these studies. The Agency concluded that using a more realistic NOAEL of 8.46 mg/ kg/ day, rather than 5 mg/ kg/ day, would provide a sufficiently protective dose for risk assessment.

° The short term dermal endpoint has a 10x UF for intraspecies variability and 10x UF for interspecies extrapolation. When considering the FQPA Safety Factor of 3x, MOEs must be $ 300 to be above the Agency's level of concern.

° The short term exposure estimates are considered high end estimates, since the maximum application rate is used, a 100% dermal absorption factor is assumed and exposures are assumed to occur on the day of treatment. ° The exposure scenario is based on low contact activity golf course reentry. The route of exposure is dermal. The population at risk are adults. 6 ° The short term Margin of Exposure (MOE) for golf course reentry using zero day after treatment (DAT 0) turf transferable residue data from the turf study is 1000. Therefore, the Agency is not concerned about short term residential exposure to pronamide.

Intermediate Term No intermediate or long term exposure scenarios (i. e., greater than 30 days) are anticipated based on the results of the turf transferable residue (TTR) study which showed that residues dissipate to below the level of quantification by day 14 following application.

Cancer Risk ° As stated previously, pronamide is classified as a Group B2 chemical, probable human carcinogen with inadequate evidence in humans.

° The cancer potency (Q1*) is 2.59 x 10 2 (mg/ kg/ day) 1 in human equivalents.

° The adult golfer cancer risk is estimated at 1.15 x 10 7 . In order to exceed the cancer risk (1.0 x 10 6 ), an exposure frequency of 8.7 days per year would be needed for the activity of golf. Because pronamide is applied one time per year, the Agency does not believe this exposure frequency will occur. Therefore, the cancer risk for golfers does not exceed the Agency's level of concern.

Drinking Water Dietary Risk (For a complete discussion, see section 4.3 of the Human Health Risk Assessment)

Drinking water exposure to pesticides can occur through groundwater and surface water contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks and uses either modeling or actual monitoring data, if available, to estimate those risks.

° A Tier I Drinking Water Assessment for pronamide was conducted using the SCI GROW model for groundwater. The Tier I groundwater estimates were predicted from application of pronamide at the maximum label rate (2 lbs active ingredient per acre four times per year) for ornamental herbaceous plants, and represent upper bound estimates of the concentrations that might be found in groundwater due to the use of pronamide/ propyzamide. The resulting modeled groundwater screening concentration is 1.1 ppb.

° The Tier II PRZM EXAMS model was used to predict EECs for pronamide in surface water. Conservative inputs were used for the environmental (soil and water metabolism) assumptions, (i. e., 2x and 3x extrapolation factors were applied to soil and water halflives used in the PRZM EXAMS assessment). Maximum label application rates were 7 used for major crops. The chronic EEC values ranged from 0.53 to 4.45 ppb (the low end crop was lettuce in Florida, and the high end crop was alfalfa in California). Using the 36 year mean concentration values for cancer risk estimates, the average exposure values ranged from 0.54 to 4.3 ppb.

° Although there is no legal requirement under the Safe Drinking Water Act to monitor for pronamide, it has been detected in surface and groundwater in various locations in the U. S. The maximum level detected was 0.365 ppb (surface water) at Zollner Creek near Mt. Abgel, Oregon on Nov. 16, 1998 and the range was 0.0037 to 0.365 ppb (surface water) (USGS  NAWQA). The maximum ground water detection was at Benton Ozark, AK at 0.82 ppb on April 13, 1994, and ranging from 0.005  0.82 ppb.

° Short term and chronic drinking water exposure to pronamide did not result in a risk estimate of concern for non cancer risks. The short term EECs ranged between 3.7 to 10.3 ppb, depending on the crop, compared to the DWLOC which ranged from 560 to 700 ppb. The chronic non cancer EECs ranged between 0.53 to 4.45 ppb, depending on the crop, compared to the chronic DWLOC which ranged between 300 to 1050 ppb.

° There are cancer risk estimates which slightly exceed the Agency's level of concern. While the modeled groundwater EEC is 1.1 ppb compared to the cancer DWLOC 1.06 ppb, the modeled surface water EECs exceed the DWLOC for some crops (the surface water cancer EECs range from 0.54 to 4.3 ppb).

Aggregate Risk (For a complete discussion, see section 5.0 of the Human Health Risk Assessment and Addendum to EPA March 8, 2002: Pronamide. Tolerance Reassessment Eligibility Decision (TRED))

FQPA requires an aggregate risk assessment to be conducted considering all nonoccupational sources, including exposure from water, food, and residential use. Because there are potential exposures to treated turf, the aggregate exposure assessment for pronamide includes exposure estimates from residential sources as well as food and drinking water.

The Agency uses a drinking water level of comparison (DWLOC) as a surrogate to capture risk associated with exposure from pesticides in drinking water. The DWLOCs represent the maximum contribution to the human diet (in ppb or : g/ L) that may be attributed to residues of a pesticide in drinking water after dietary exposure is subtracted from the chronic Population Adjusted Dose (cPAD) or cPAD. Risks from drinking water are assessed by comparing the DWLOCs to the estimated environmental concentrations (EECs) in surface water and groundwater. If the EEC is less than the DWLOC, there is generally no drinking water concerns. The EECs for average concentrations of pronamide were based on PRZM EXAMS for surface water and SCI GROW for groundwater. Drinking water modeling is considered to be an unrefined assessment and provides high end estimates. 8 Short Term Risk The short term food, water, and low contact dermal (golfing) pronamide exposures were aggregated in the Risk Assessment, and the estimated environmental concentration (EECs) for surface water (3.69 to 10.3 ppb) and ground water (1.1 ppb), modeled using SCI GROW and PRZM EXAMS, did not exceed the DWLOC (range 560 700 ppb). Therefore, risk estimates for all pathways of exposure are not of concern for pronamide short term exposure when pronamide use is restricted per the label changes cited above.

Chronic Risk Due to the short term, intermittent nature of residential exposure to pronamide, only dietary and water intake were included in the chronic aggregate exposure estimate. The chronic DWLOC is the concentration in drinking water as a part of the aggregate chronic exposure that occupies no more than 100% of the cPAD when considered together with other sources of exposure.

To calculate the chronic DWLOC exposure relative to a chronic toxicity endpoint, the chronic dietary food exposure (from DEEM™) was subtracted from the chronic PAD to obtain the acceptable chronic exposure to pronamide in drinking water. The DWLOC was calculated and compared to the EECs.

° The chronic DWLOCs (300  1050 ppb) were greater than the EECs for modeled surface water (0.53  4.45 ppb), and modeled groundwater (1.1 ppb). In addition, non targeted USGS monitoring data ranged from 0.0037 to 0.365 ppb in surface water, and from 0.005  0.82 ppb in ground water. The Agency concludes the chronic aggregate risk estimates do not exceed the level of concern.

Cancer Risk Aggregate cancer risk estimates will be reduced by restricting non agricultural uses to turf for sod and seed, ornamental landscaping, industrial sites, professional athletic fields, and golf courses. Golfing is believed to be a representative scenario for likely exposures to the public.

° The cancer risk estimate for golfing a single day per year is about the same as the dietary cancer risk estimate, or 1 x 10 7 . After considering both dietary and non dietary exposure, the cancer DWLOC is 1.06 ppb. Without golf course exposure (i. e., no recreational turf uses at all), the cancer DWLOC would be 1.2 ppb based on food exposure alone.

° The Tier 2 PRZM EXAMS 36 year mean EECs are 0.535 4.35 ppb. The modeled groundwater EEC using SCI GROW is 1.1 ppb. 9 ° While the modeled EECs (4.35 ppb) are slightly higher than the cancer DWLOC (1.06 ppb), the Agency is not concerned because of the conservative inputs used in the surface water modeling. The PRZM EXAMS assessment was based on the maximum label rates for pronamide, whereas typical rates for many crops are 25% 50% less. The model also assumed a Percent Crop Area (PCA) of 87%, which is likely to be an overestimate for the commodities being assessed. In addition, pronamide data exists for only one soil in the aerobic soil metabolism study. When aerobic soil metabolism data is only available in one soil, a conservative extrapolation factor is used which is likely to contribute to overestimating potential persistence and exposure. As a result, Dow AgroSciences has agreed to conduct an aerobic soil metabolism study (two additional soils) and an aerobic aquatic metabolism study as confirmatory data.

° Further refinement of drinking water modeling estimates and/ or targeted monitoring of water sources in high pronamide use areas would provide more confidence in the risk assessment. Additionally, information concerning the behavior of pronamide following drinking water treatment regimes would also help refine exposure estimates.

Tolerance Reassessment Summary Pronamide tolerances are established under 40 CFR §180.317 (a), (b) and (c). The tolerance expression, listed in (a) and (c), is in terms of the combined residues of the herbicide propyzamide and its metabolites (containing the 3, 5 dichlorobenzoyl moiety and calculated as 3, 5 dichloro N (1,1 dimethyl 2 propynyl) benzamide). The tolerance expression, listed in (b), is in terms of the parent only. The Agency recommends that the tolerance expression under (b) be modified to include the metabolites. The Agency also recommends the following: decreasing the established tolerance for artichokes; increasing the tolerances for cattle fat, goat fat, hog fat, horse fat, and sheep fat, revoking the tolerance for poultry kidney, grass, forage: and, proposing a tolerance for alfalfa seed. The Table below summarizes EPA's tolerance reassessment decision which accounts for 47 tolerance reassessments.

The Codex Commission has established several maximum residue limits (MRLs) for residues of pronamide in/ on various raw agricultural and processed commodities. The Codex MRLs are expressed in terms of pronamide per se. The Codex MRLs and the U. S. tolerances will be incompatible when the U. S. tolerance expression for plant commodities is revised to include residues of pronamide and the metabolites. 10 Tolerance Reassessment Summary for Pronamide Commodity Established Tolerance (ppm) Reassessed Tolerance (ppm) Comment Correct Commodity definition Tolerances Listed Under 40 CFR §180.317( a) Apples 0.1 0. 1 Artichokes 0.1 0. 01 Residues of pronamide and its metabolites containing the 3,5 dichlorobenzoyl moiety were nondetectable (less than the level of concern (LOC) of 0.01ppm) in/ on each sample of artichokes harvested 61 days following a single application of a representative pronamide formulation at 4.0 or 8.0 lb ai/ A.

Blackberries 0.05 0.05 Blueberries 0.05 0.05 Boysenberries 0.05 0.05 Cattle, fat 0.02 0.20 Fat tolerance raised due to linear extrapolation of maximum residues observed in fat at 40 ppm feeding level relative to the Maximum theoretical dietary burdens (MTDB)

Cattle, kidney 0. 4 0.4 Cattle, liver 0.4 0. 4 Cattle, mbyp (except kidney, liver) 0. 02 0. 02 Cattle, meat 0.02 0.02 Eggs 0.02 0.02 Endive (escarole) 1.0 1. 0 Goats, fat 0.02 0.20 Fat tolerance raised due to linear extrapolation of maximum residues observed in fat at 40 ppm feeding level relative to the MTDB Goats, kidney 0.4 0. 4 Goats, liver 0.4 0. 4 Goats, mbyp (except kidney, liver) 0. 02 0. 02 Goats, meat 0.02 0.02 Grapes 0.1 0. 1 Hogs, fat 0. 02 0. 20 Fat tolerance raised due to linear extrapolation of maximum residues observed in fat at 40 ppm feeding level relative to the MTDB Hogs, kidney 0. 4 0.4 Hogs, liver 0.4 0. 4 Hogs, mbyp (except kidney) 0.02 0.02 Hogs, meat 0.02 0.02 Horses, fat 0. 02 0. 20 Fat tolerance raised due to linear extrapolation of maximum residues observed in fat at 40 ppm feeding level relative to the MTDB Commodity Established Tolerance (ppm) Reassessed Tolerance (ppm) Comment Correct Commodity definition 11 Horses, kidney 0. 4 0.4 Horses, liver 0.4 0. 4 Horses, mbyp (except kidney) 0.02 0.02 Horses, meat 0.02 0.02 Lettuce 1.0 1. 0 Lettuce Head Only head lettuce is supported by acceptable data; leaf lettuce uses must be removed from the label. Alternatively, the label may be revised to specify a practical PHI (35 day) for leaf lettuce and supporting data be submitted.

Milk 0.02 0.02 Non grass animal feeds 10.0 10.0 Non grass animal feeds (forage, fodder, straw, and hay) group Pears 0. 1 0.1 Poultry, fat 0. 02 0. 02 Poultry, kidney 0. 2 Revoke Tolerances are typically not established for poultry kidneys.

Poultry, liver 0.2 0. 2 Poultry, mbyp (except kidney, liver) 0.02 0.02 Poultry, meat 0.02 0.02 Radicchio, greens (tops) 2. 0 2.0 Raspberries 0.05 0.05 Sheep, fat 0. 02 0. 20 Fat tolerance raised due to linear extrapolation of maximum residues observed in fat at 40 ppm feeding level relative to the MTDB Sheep, kidney 0. 4 0.4 Sheep, liver 0.4 0. 4 Sheep, mbyp (except kidney, liver) 0.02 0.02 Sheep, meat 0.02 0.02 Stone fruit 0.1 0. 1 Commodity Established Tolerance (ppm) Reassessed Tolerance (ppm) Comment Correct Commodity definition 12 Tolerances To Be Proposed Under 40 CFR §180.317( a) Alfalfa Seed  10.0 Tolerance recommendation is contingent upon required label revision to specify a 50 day PHI and a maximum seasonal rate of 2.0 lb ai/ A Tolerances Listed Under 40 CFR §180.317( b) Cranberries 0.05  Temporary tolerance associated with a FIFRA section 18 that will expire 12/ 31/ 03. Grass, forage 1.0  Tolerance expired 12// 31/ 01. Tolerances Listed Under 40 CFR §180.317( c) Peas, dried 0. 05 TBD Pea, field, seed. European data currently used to support tolerance. Registrant needs to submit field trial data as confirmatory data. Rhubarb 0.1 0. 1 Tolerances To Be Proposed Under 40 CFR §180.317( c) Pea, field, hay – TBD Pea, field vines – TBD *TBD= To Be Determined Summary of Pending Data Most pertinent product chemistry data requirements are satisfied for technical grade active ingredients. The following information is required:

° Product Chemistry GDLN Description 860.1200 Direction for use 860.1380 Storage Stability Data ° Additional data are also required for the 51% Formulation Intermediate (FI) concerning the following:

GDLN Description 830.6314 oxidation/ reduction 830.6316 explodability 830.6317 storage stability 830.6320 corrosion characteristics 13 The registrant must either certify that the supplier of beginning materials and the manufacturing processes have not changed since the last comprehensive product chemistry reviews or submit complete updated product chemistry data packages.

Although there is confidence in the overall scientific quality of the available toxicity data, several data gaps were identified which are required to fulfill the OPPTS harmonized test guidelines:

° Toxicity GDLN Description 870.3700 Developmental study in rats Non GDLN Comparative thyroid rat assay in adult animals and offspring 870.3200 21 day dermal toxicity study Non GDLN 28 day inhalation study 870.7600 dermal penetration study A review of registered uses and the supporting residue chemistry data indicates the following residue data are required:

° Residue (GDLN 860.1500 Crop Field Trials)

dried winter peas vines and hay of winter peas ° Confirmatory storage stability data (GDLN 860.1380) are required for regulated pronamide metabolites on the following:

alfalfa apples grapes lettuce peaches plums ° A confirmatory aerobic soil metabolism study (835.4100) and an aerobic aquatic metabolism study (835.4300) are required.

The registrant is required to further optimize/ improve the revised animal enforcement method (TR 34 91 68) to yield acceptable recoveries at a fortification level equal to established animal tolerances. Following method improvement, the registrant is required to submit bridging independent laboratory validation (ILV) data; the required ILV data should include two control samples fortified at 0.4 ppm, the reassessed tolerance level for the kidney and liver of ruminants. 14 ° The following label amendments are required for lettuce, peas, and alfalfa grown for seed:

GDLN Description 860.1850 Confined Accumulation in Rotational Crops 860.1900 Field Accumulation in Rotational Crops ° 30 day plant back interval for leafy vegetables (except Brassica vegetables) ° 90 day plant back interval for root and tuber vegetables ° 360 day plant back interval for cereal grains, forage and fodder, and straw of cereal grain


[Federal Register Volume 82, Number 23 (Monday, February 6, 2017)]
[Notices]
[Page 9377]
[FR Doc No: 2017-02419]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 7569-005]

City of South Bend, Indiana, University of Notre Dame; Notice of
Transfer of Exemption

    1. By letter filed December 15, 2016, the City of South Bend,
Indiana and The University of Notre Dame informed the Commission that
the exemption from licensing for the South Bend Hydroelectric Project
No. 7569, originally issued April 18, 1984 \1\ has been transferred to
the University of Notre Dame. The project is located on the St. Joseph
River in St. Joseph County, Indiana. The transfer of an exemption does
not require Commission approval.
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    \1\ Order Granting Exemption from Licensing of a Small
Hydroelectric Project of 5 Megawatts or Less. City of South Bend,
Indiana, 27 FERC 62,056 (1984).
---------------------------------------------------------------------------

    2. The University of Notre Dame is now the exemptee of the South
Bend Hydroelectric Project No. 7569. All correspondence should be
forwarded to: Mr. Paul Kempf, Director of Utilities & Maintenance, The
University of Notre Dame, 100 Facilities Building, Notre Dame, IN
46556, Phone:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>
    Dated: January 31, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-02419 Filed 2-3-17; 8:45 am]
 BILLING CODE 6717-01-P