[Federal Register Volume 82, Number 157 (Wednesday, August 16, 2017)]
[Rules and Regulations]
[Pages 38846-38849]
[FR Doc No: 2017-17337]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0108; FRL-9964-53]

Fatty Acids, Rape-Oil, Triesters With Polyethylene Glycol Ether
With Glycerol (3:1); Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of fatty acids, rape-oil, triesters with
polyethylene glycol ether with glycerol (3:1) (CAS Reg. No. 688045-21-
8) when used as an inert ingredient in a pesticide chemical
formulation. Seppic, Inc. submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of fatty acids,
rape-oil, triesters with polyethylene glycol ether with glycerol (3:1)
on food or feed commodities.

DATES: This regulation is effective August 16, 2017. Objections and
requests for hearings must be received on or before October 16, 2017,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0108, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301

Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is<PHONE_NUMBER>, and the telephone number for the OPP Docket is
(703) 305-5805. Please review the visitor instructions and additional
information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0108 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 16, 2017. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0108, by one of
the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of June 8, 2017 (82 FR 26641) (FRL-9961-
14), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (PP IN-11003)
filed by SEPPIC INC., 30 TWO Bridges Road, Suite 210, Fairfield, New
Jersey 07004. The petition requested that 40 CFR 180.960 be amended by
establishing an exemption from the requirement of a tolerance for
residues of fatty acids, rape-oil, triesters with polyethylene glycol
ether with glycerol (3:1) (CAS Reg. No. 688045-21-8). That document
included a summary of the petition prepared by the petitioner and
solicited comments on the petitioner's request. The Agency did not
receive any comments. Section 408(c)(2)(A)(i) of FFDCA allows EPA to
establish an exemption from the requirement for a tolerance (the legal
limit for a pesticide chemical residue in or on a food) only if EPA
determines that the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of
FFDCA defines ``safe'' to mean that ``there is a reasonable certainty
that no harm will result from aggregate exposure to the pesticide
chemical residue, including all anticipated dietary exposures and all
other exposures for which there is reliable information.'' This
includes exposure through drinking water and use in residential
settings, but does not include occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to give special consideration to
exposure of infants and children to the pesticide chemical residue in
establishing an exemption from the requirement of a tolerance and to
``ensure that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to the pesticide
chemical residue . . .'' and specifies factors EPA is to consider in
establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). fatty acids, rape-oil, triesters

with polyethylene glycol ether with glycerol (3:1) conforms to the
definition of a polymer given in 40 CFR 723.250(b) and meets the
following criteria that are used to identify low-risk polymers.
    1. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
    2. The polymer does contain as an integral part of its composition
the atomic elements carbon, hydrogen, and oxygen.
    3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
    Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
    7. The polymer's minimum number average MW of 1800 amu is greater
than 1,000 and less than 10,000 daltons. The polymer contains less than
10% oligomeric material below MW 500 and less than 25% oligomeric
material below MW 1,000, and the polymer does not contain any reactive
functional groups.
    Thus, fatty acids, rape-oil, triesters with polyethylene glycol
ether with glycerol (3:1) meets the criteria for a polymer to be
considered low risk under 40 CFR 723.250. Based on its conformance to
the criteria in this unit, no mammalian toxicity is anticipated from
dietary, inhalation, or dermal exposure to fatty acids, rape-oil,
triesters with polyethylene glycol ether with glycerol (3:1).

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this
exemption, EPA considered that fatty acids, rape-oil, triesters with
polyethylene glycol ether with glycerol (3:1) could be present in all
raw and processed agricultural commodities and drinking water, and that
non-occupational non-dietary exposure was possible. The minimum number
average MW of fatty acids, rape-oil, triesters with polyethylene glycol
ether with glycerol (3:1) is 1800 amu. Generally, a polymer of this
size would be poorly absorbed through the intact gastrointestinal tract
or through intact human skin. Since fatty acids, rape-oil, triesters
with polyethylene glycol ether with glycerol (3:1) conform to the
criteria that identify a low-risk polymer, there are no concerns for
risks associated with any potential exposure scenarios that are
reasonably foreseeable. The Agency has determined that a tolerance is
not necessary to protect the public health.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not found fatty acids, rape-oil, triesters with
polyethylene glycol ether with glycerol (3:1) to share a common
mechanism of toxicity with any other substances, and fatty acids, rape-
oil, triesters with polyethylene glycol ether with glycerol (3:1) does
not appear to produce a toxic metabolite produced by other substances.
For the purposes of this tolerance action, therefore, EPA has assumed
that fatty acids, rape-oil, triesters with polyethylene glycol ether
with glycerol (3:1) does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of fatty acids, rape-oil,
triesters with polyethylene glycol ether with glycerol (3:1), EPA has
not used a safety factor analysis to assess the risk. For the same
reasons the additional tenfold safety factor is unnecessary.

VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of fatty acids, rape-oil, triesters with
polyethylene glycol ether with glycerol (3:1).

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for fatty acids, rape-oil,
triesters with polyethylene glycol ether with glycerol (3:1).

VIII. Conclusion

    Accordingly, EPA finds that exempting residues of fatty acids,
rape-oil, triesters with polyethylene glycol ether with glycerol (3:1)
from the requirement of a tolerance will be safe.

IX. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning

Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

X. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: July 18, 2017.
Donna S. Davis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.960, alphabetically add the polymers in the table to
read as follows:

Sec.  [emsp14]180.960  Polymers; exemptions from the requirement of a
tolerance.

* * * * *

------------------------------------------------------------------------
                         Polymer                              CAS No.
------------------------------------------------------------------------

                              * * * * * * *
Fatty acids, rape-oil, triesters with polyethylene           688045-21-8
 glycol ether with glycerol (3:1); minimum number
 average molecular weight (in amu), 1800................

                              * * * * * * *
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[FR Doc. 2017-17337 Filed 8-15-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 223 (Thursday, November 19, 2015)]
[Notices]
[Pages 72447-72448]
[FR Doc No: 2015-29576]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2015-0636]

Collection of Information Under Review by Office of Management
and Budget; OMB Control Number: 1625-0088

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting approval of a
revision to the following collection of information: 1625-0088, Voyage
Planning for Tank Barge Transits in the Northeast United States. Our
ICR describes the information we seek to collect from the public.
Review and comments by OIRA ensure we only impose paperwork burdens
commensurate with our performance of duties.

DATES: Comments must reach the Coast Guard and OIRA on or before
December 21, 2015.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2015-0636] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. Alternatively, you
may submit comments to OIRA using one of the following means:
    (1) Email<EMAIL_ADDRESS>    (2) Mail: OIRA, 725 17th Street NW., Washington, DC 20503,
attention Desk Officer for the Coast Guard.
    (3) Fax:<PHONE_NUMBER>. To ensure your comments are received in a
timely manner, mark the fax, attention Desk Officer for the Coast
Guard.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
COMMANDANT (CG-612), ATTN: PAPERWORK REDUCTION ACT MANAGER, U.S. COAST
GUARD, 2703 MARTIN LUTHER KING JR. AVE. SE., STOP 7710, WASHINGTON, DC
20593-7710.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection. The Coast Guard invites comments on whether
this ICR should be granted based on the Collection being necessary for
the proper performance of Departmental functions. In particular, the
Coast Guard would appreciate comments addressing: (1) The practical
utility of the Collection; (2) the accuracy of the estimated burden of
the Collection; (3) ways to enhance the quality, utility, and clarity
of information subject to the Collection; and (4) ways to minimize the
burden of the Collection on respondents, including the use of automated
collection techniques or other forms of information technology. These
comments will help OIRA determine whether to approve the ICR referred
to in this Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2015-0636], and must be received by December 21,
2015.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that Web site's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Number: 1625-0088.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard has published the 60-day notice (80 FR 48552, August 13,
2015) required by 44 U.S.C. 3506(c)(2). That Notice elicited no
comments. Accordingly, no changes have been made to the Collection.

Information Collection Request

    1. Title: Voyage Planning for Tank Barge Transits in the Northeast
United States.
    OMB Control Number: 1625-0088.
    Summary: The information collection requirement for a voyage plan
serves as a preventive measure and assists in ensuring the successful
execution and completion of a voyage in the First Coast Guard District.
This rule (33 CFR 165.100) applies to primary towing vessels engaged in
towing tank barges carrying petroleum oil in bulk as cargo.
    Need: Section 311 of the Coast Guard Authorization Act of 1998,
Pub. L. 105-383, 33 U.S.C. 1231, and 46 U.S.C. 3719 authorize the Coast
Guard to promulgate regulations for towing vessel and barge safety for
the waters of the Northeast subject to the jurisdiction of the First
Coast Guard District. This regulation is contained in 33 CFR 165.100.
The information for a voyage plan will provide a mechanism for
assisting vessels towing tank barges to identify those specific risks,
potential equipment, failures, or human errors that may lead to
accidents.

    Forms: None.
    Respondents: Owners and operators of towing vessels. The annual
number of respondents is estimated at 1,759.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has decreased from 1,116
hours to 880 hours a year due to a decrease in the estimated annual
number of responses.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
chapter 35, as amended.

    Dated: November 10, 2015.
Thomas P. Michelli,
U.S. Coast Guard, Deputy Chief Information Officer.
[FR Doc. 2015-29576 Filed 11-18-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 31 (Tuesday, February 15, 2011)]
[Rules and Regulations]
[Pages 8658-8659]
[FR Doc No: 2011-3322]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

46 CFR Part 148

[USCG-2009-0091]
RIN 1625-AB47

Bulk Solid Hazardous Materials: Harmonization With the
International Maritime Solid Bulk Cargoes (IMSBC) Code

AGENCY: Coast Guard, DHS.

ACTION: Rule; information collection approval.

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SUMMARY: On October 19, 2010, the Coast Guard amended its regulations
governing the carriage of solid hazardous materials in bulk to allow
use of the IMSBC Code as an equivalent form of compliance. The
amendment triggered information collection requirements affecting the
Special Permits issued by the Coast Guard that allow the carriage of
hazardous bulk solid materials not addressed in the amended
regulations. This notice announces that the collection of information
has been approved by the Office of Management and Budget

(OMB) and may now be enforced. The OMB control number is 1625-0025.

DATES: The collection of information requirement under 46 CFR part 148
will be enforced beginning February 15, 2011.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
document, contact Mr. Richard Bornhorst at<PHONE_NUMBER> or
<EMAIL_ADDRESS>If you have questions about viewing the
docket (USCG-2009-0091), call Ms. Renee V. Wright, Program Manager,
Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On January 1, 2011, compliance with the
IMSBC Code became mandatory for all vessels subject to the
International Convention for the Safety of Life at Sea (SOLAS), 1974,
as amended, that carry bulk solid cargoes other than grain. The final
rule (75 FR 64586) allows use of the IMSBC Code as an alternate form of
compliance with 46 CFR part 148, subject to conditions and limitations.
The rule reduces the need for the current Special Permits for the
carriage of certain solid hazardous materials in bulk.
    The Coast Guard issues Special Permits as part of its mission to
ensure maritime safety and facilitate U.S. commerce. To ensure that the
carriage requirements imposed by the Special Permit are sufficient and
that the permit holder is complying with the terms of the permit, the
Coast Guard requires the submission of information concerning the
history of shipments made under the terms of the Special Permit.
    With the exception of this collection of information, the Bulk
Solid Hazardous Materials: Harmonization With the International
Maritime Solid Bulk Cargoes (IMSBC) Code rule became effective on
January 1, 2011. Under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520), an agency may not conduct or sponsor a collection of
information until the collection is approved by OMB. Accordingly, the
preamble to the final rule stated that the Coast Guard would not
enforce the collection of information requirements occurring under 46
CFR part 148 until the collection of information request was approved
by OMB, and also stated that the Coast Guard would publish a notice in
the Federal Register announcing that OMB approved and assigned a
control number for the requirement.
    The Coast Guard submitted the information collection request to OMB
for approval in accordance with the Paperwork Reduction Act of 1995. On
January 28, 2011, OMB approved the collection of information and
assigned the collection OMB Control Number 1625-0025 entitled
``Carriage of Bulk Solids Requiring Special Handling--46 CFR 148''. The
approval for this collection of information expires on January 31,
2014. A copy of the OMB notice of action is available in our online
docket (USCG-2009-0091) at http://www.regulations.gov.

    Dated: February 7, 2011.
F.J. Sturm,
Acting Director of Commercial Regulations and Standards, U.S. Coast
Guard.
[FR Doc. 2011-3322 Filed 2-14-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: August 1, 2007 (Volume 72, Number 147)]
[Notices]
[Page 42082-42083]
[DOCID:fr01au07-60]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0218; FRL-8130-2]

Pesticides; Science Policy; Notice of Withdrawal

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY:  EPA announces the withdrawal of the revised version of the
pesticide science policy document ``Standard Operating Procedures for
Incorporating Screening-Level Estimates of Drinking Water Exposure into
Aggregate Risk Assessments'' http://www.epa.gov/oppfead1/trac/science/screeningsop.pdf.
 This science policy document was developed during the

implementation of the new safety standard in section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA). EPA's assessment of exposure to
pesticide residues in drinking water no longer involves performing
screening level assessments as described in this policy paper.
Accordingly, EPA is withdrawing this science policy document. Instead,
the Agency now routinely develops estimates of exposure to pesticides
in drinking water using the more advanced

methods that EPA has described in other science policy papers.

FOR FURTHER INFORMATION CONTACT: David J. Miller, Health Effects
Division, Office of Pesticide Programs (7509P), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action,
however, may be of interest to persons who produce or formulate
pesticides or who register pesticide products. Since other entities may
also be interested, the Agency has not attempted to describe all the
specific entities that may be affected by this action. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2007-0218. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard

copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The hours of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket Facility telephone number is<PHONE_NUMBER>.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

II. Background

    On August 3, 1996, FQPA was signed into law. The FQPA significantly
amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
and FFDCA. Among other changes, FQPA established a stringent health-
based standard (``a reasonable certainty of no harm'') for pesticide
residues in foods to assure protection from unacceptable pesticide
exposure and strengthened health protections for infants and children
from pesticide risks.
    During 1998 and 1999, EPA and the U.S. Department of Agriculture
(USDA) established a subcommittee of the National Advisory Council For
Environmental Policy and Technology (NACEPT), the Tolerance
Reassessment Advisory Committee (TRAC), to address FFDCA issues and
implementation. TRAC comprised more than 50 representatives of affected
user, producer, consumer, public health, environmental, states, and
other interested groups. The TRAC met from May 27, 1998, through April
29, 1999.
    In order to continue the constructive discussions about FFDCA, in
2000 EPA and USDA established, under the auspices of NACEPT, the
Committee to Advise on Reassessment and Transition (CARAT). The CARAT
provided a forum for a broad spectrum of stakeholders to consult with
and advise the Agency and the Secretary of Agriculture on pest and
pesticide management transition issues related to the tolerance
reassessment process. The CARAT was intended to further the valuable
work initiated by earlier advisory committees toward the use of sound
science and greater transparency in regulatory decision-making,
increased stakeholder participation, and reasonable transition
strategies that reduce risks without jeopardizing American agriculture
and farm communities.
    As a result of the 1998 and 1999 TRAC process, EPA decided that the
implementation process and related policies would benefit from
providing notice and comment on major science policy issues. The TRAC
identified nine science policy areas it believed were key to
implementation of tolerance reassessment. EPA agreed to provide one or
more documents for comment on each of the nine issues by announcing
their availability in the Federal Register. In a notice published in
the Federal Register of October 29, 1998 (63 FR 58038) (FRL-6041-5),
EPA described its intended approach. Since then, EPA has issued a
series of draft and revised documents concerning the nine science
policy issues. Publication of this notice is intended to update the
public on the status of two of the FQPA science policy papers.

III. Summary: Why the Policy Is No Longer Needed

    As a result of the new procedures for estimating concentrations of
pesticide residues in drinking water, this notice announces the
withdrawal of ``Standard Operating Procedures for Incorporating
Screening-Level Estimates of Drinking Water Exposure into Aggregate
Risk Assessments'' http://www.epa.gov/fedrgstr/EPA-PEST/2000/October/Day-11/p25934.htm
.

    In assessing the risks of pesticide exposure, scientists frequently
use mathematical models to predict pesticide concentrations in food,
water, residential, and occupational environments. This notice pertains
to how the Agency determines pesticide risk from drinking water. (For
more information on the models the Agency uses to estimate
concentrations of pesticides in drinking water see http://www.epa.gov/oppefed1/models/water/models4.htm
). This approach provides a more

realistic estimate of exposure through drinking water since actual
drinking water consumption data and reported body weight from the
Combined Survey of Food Intake by Individuals (CSFII) are used, rather
than the standard assumptions used in the Drinking Water Level of
Comparison approach.
    This action is also responsive to the recommendations made by EPA's
Office of Inspector General during its review of EPA's implementation
of FQPA. In its report ``Opportunities to Improve Data Quality and
Children's Health through the FQPA'' issued January 10, 2006 http://www.epa.gov/oigearth/reports/2006/20060110-2006-P-00009.pdf
, the Office

of Inspector General recommended that EPA should update the status of
its Science Policy issue papers. This Federal Register notice updates
the public on the status of one of the Science Policy papers which has
been rendered obsolete by the availability of more robust data and
models.

List of Subjects

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests.

    Dated: July 20, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E7-14685 Filed 7-31-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: July 2, 2008 (Volume 73, Number 128)]
[Rules and Regulations]
[Page 37843-37844]
[DOCID:fr02jy08-33]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2008-0180; FRL-8687-3]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Section 110(a)(1) 8-Hour Ozone Maintenance Plan and 2002
Base-Year Inventory for the Crawford County Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is approving a State Implementation Plan (SIP) revision
submitted by the Commonwealth of Pennsylvania. The Pennsylvania
Department of Environmental Protection (PADEP) submitted a SIP revision
consisting of a maintenance plan that provides for continued attainment
of the 8-hour ozone national ambient air quality standard (NAAQS) for
at least 10 years after the April 30, 2004 designations, as well as a
2002 base-year inventory for the Crawford County Area. EPA is approving
the maintenance plan and the 2002 base-year inventory for the Crawford
County Area as revisions to the Pennsylvania SIP in accordance with the
requirements of the Clean Air Act (CAA).

DATES: Effective Date: This final rule is effective on August 1, 2008.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2008-0180. All documents in the docket are listed in
the http://www.regulations.gov website. Although listed in the
electronic docket, some information is not publicly available, i.e.,
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically through http://
www.regulations.gov or in hard copy for public inspection during normal
business hours at the Air Protection Division, U.S. Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania 19103. Copies of the State submittal are available at the
Pennsylvania Department of Environment Protection, Bureau of Air
Quality Control, P.O. Box 8468, 400 Market Street, Harrisburg,
Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Gregory Becoat,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On May 14, 2008 (73 FR 27791), EPA published a notice of proposed
rulemaking (NPR) for the Commonwealth of Pennsylvania. The NPR proposed
approval of Pennsylvania's SIP revision that establishes a maintenance
plan for the Crawford County Area that provides for continued
attainment of the 8-hour ozone NAAQS for at least 10 years after
designation, and a 2002 base-year emissions inventory. The formal SIP
revisions were submitted by PADEP on December 17, 2007. Other specific
requirements of Pennsylvania's SIP revision and the rationales for
EPA's proposed actions are explained in the NPR and will not be
restated here. No public comments were received on the NPR.

II. Final Action

    EPA is approving the maintenance plan and the 2002 base-year
inventory for the Crawford County Area, submitted on December 17, 2007,
as revisions to the Pennsylvania SIP. EPA is approving the maintenance
plan and 2002 base-year inventory for the Crawford County Area because
it meets the requirements of section 110(a)(1) of the CAA.

III. Statutory and Executive Order Reviews

A. General Requirements

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52. 02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct

costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 2, 2008. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action.
    This action approving the maintenance plan and the 2002 base-year
inventory for the Crawford County Area may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements, Volatile organic
compounds.

    Dated: June 24, 2008.
Donald S. Welsh,
Regional Administrator, Region III.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDed]

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

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

Subpart NN--Pennsylvania

0
2. In Sec.  52. 2020, the table in paragraph (e)(1) is amended by
adding an entry for the 8-Hour Ozone Maintenance Plan and 2002 Base-
Year Inventory for Crawford County at the end of the table to read as
follows:

Sec.  52.2020  Identification of plan.

    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                                            State
    Name of non-regulatory SIP          Applicable        submittal     EPA approval date        Additional
             revision                 geographic area        date                                explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
8-Hour Ozone Maintenance Plan and  Crawford County.....     12/17/07  7/02/08. [Insert      ....................
 2002 Base-Year Inventory.                                             page number where
                                                                       the document
                                                                       begins].
----------------------------------------------------------------------------------------------------------------

* * * * *
 [FR Doc. E8-14868 Filed 7-1-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 109 (Wednesday, June 7, 2023)]
[Proposed Rules]
[Pages 37177-37179]
[FR Doc No: 2023-12090]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 88, No. 109 / Wednesday, June 7, 2023 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2023-1329; Airspace Docket No. 23-AEA-2]
RIN 2120-AA66

Establishment of United States Area Navigation (RNAV) Routes T-
440, T-455, T-457, T-459, and T-476, and Amendment of RNAV Routes T-
358, T-416, and T-445; Eastern United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to establish United States Area
Navigation (RNAV) routes T-440, T-455, T-457, T-459, and T-476, and
amend RNAV routes T-358, T-416, and T-445 in support of the FAA's Very
High Frequency (VHF) Omnidirectional Range (VOR) Minimum Operational
Network (MON) Program. The purpose is to enhance the efficiency of the
National Airspace System (NAS) by transitioning from ground-based
navigation aids to a satellite-based navigation system.

DATES: Comments must be received on or before July 24, 2023.

ADDRESSES: Send comments identified by FAA Docket No. FAA-2023-1329 and
Airspace Docket No. 23-AEA-2 using any of the following methods:
    * Federal eRulemaking Portal: Go to www.regulations.gov and follow
the online instructions for sending your comments electronically.
    * Mail: Send comments to Docket Operations, M-30; U.S. Department
of Transportation, 1200 New Jersey Avenue SE, Room W12-140, West
Building Ground Floor, Washington, DC 20590-0001.
    * Hand Delivery or Courier: Take comments to Docket Operations in
Room W12-140 of the West Building Ground Floor at 1200 New Jersey
Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    * Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Docket: Background documents or comments received may be read at
www.regulations.gov at any time. Follow the online instructions for
accessing the docket or go to the Docket Operations in Room W12-140 of
the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    FAA Order JO 7400.11F, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Brian Vidis, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would modify the route structure as to improve the
efficient flow of air traffic within the NAS while lessening the
dependency on ground-based navigation.

Comments Invited

    The FAA invites interested persons to participate in this
rulemaking by submitting written comments, data, or views. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal. The most
helpful comments reference a specific portion of the proposal, explain
the reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should submit only one time if comments are filed electronically, or
commenters should send only one copy of written comments if comments
are filed in writing.
    The FAA will file in the docket all comments it receives, as well
as a report summarizing each substantive public contact with FAA
personnel concerning this proposed rulemaking. Before acting on this
proposal, the FAA will consider all comments it receives on or before
the closing date for comments. The FAA will consider comments filed
after the comment period has closed if it is possible to do so without
incurring expense or delay. The FAA may change this proposal in light
of the comments it receives.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

Availability of Rulemaking Documents

    An electronic copy of this document may be downloaded through the
internet at www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at
www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Operations office (see ADDRESSES section for address, phone number, and
hours of operations). An informal docket may also be examined during
normal business hours at the office of the Eastern Service Center,
Federal Aviation Administration, Room 210, 1701 Columbia Avenue,
College Park, GA 30337.

Incorporation by Reference

    United States Area Navigation Routes are published in paragraph
6011 of FAA Order JO 7400.11, Airspace Designations and Reporting
Points, which is incorporated by reference in 14 CFR 71.1 on an annual
basis. This document proposes to amend the current version of that
order, FAA Order JO 7400.11G, dated August 19, 2022, and effective
September 15, 2022. These updates would be published in the next update
to FAA Order JO 7400.11. That order is publicly available as listed in
the ADDRESSES section of this document.
    FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 to establish
RNAV routes T-440, T-455, T-457, T-459, and T-476, and amend RNAV
routes T-358, T-416, and T-445 in support of the FAA's VOR MON Program.
The proposed changes are described below.
    T-358: T-358 currently extends from the Martinsburg, WV (MRB), VOR/
Tactical Air Navigation System (VORTAC) to the AVALO, NJ, waypoint
(WP). This action proposes to extend the current route T-358 to the
northeast from the AVALO, NJ, waypoint (WP) to the Augusta, ME (AUG),
VOR/Distance Measuring Equipment (DME). T-358 overlays VOR Federal
airway V-268 from the AVALO, NJ, WP to the BURDY, MA, WP and from the
LBSTA, MA, WP to the Augusta, ME (AUG), VOR/DME. The MOYRR, MD, WP name
is being replaced by the HAMRR, MD, WP at the same location due to
similar sounding WP names.
    T-416: T-416 currently extends from the Smyrna, NJ (ENO), VORTAC to
the PREPI, OA, WP (i.e., OA means Offshore Atlantic). This action
proposes to move the RIDNG, NJ, WP 1.83 nautical miles southwest of its
current location to align with a standard instrument departure
procedure.
    T-440: This action proposes a new route T-440 that would extend
from the Elmira, NY (ULW), VOR/DME to the TALLI, PA, WP. T-440 would
overlay VOR Federal airway V-147 from the Elmira, NY (ULW), VOR/DME to
the Wilkes-Barre, PA (LVZ), VORTAC; and airway V-116 from the Wilkes-
Barre, PA (LVZ), VORTAC to the TALLI, PA, WP.
    T-445: T-445 currently extends from the Westminster, ME (EMI),
VORTAC to the AIRCO, NY, Fix. The action proposes to delete the segment
from the Westminster, ME (EMI), VORTAC to the Harrisburg, PA (HAR),
VORTAC. Further, the Elmira, NY (ULW), VOR/DME would replace the STUBN,
NY, WP.
    T-455: This action proposes a new route T-455 that would extend
from the Allentown, PA (FJC), VORTAC to the WIGGZ, PA, WP. T-455 would
overlay airway V-613 from the Allentown, PA (FJC), VORTAC to the
Wilkes-Barre, PA (LVZ), VORTAC, and would overlay airway V-188 from the
Wilkes-Barre, PA (LVZ), VORTAC to the Slate Run, PA (SLT), VORTAC.
    T-457: This action proposes a new route T-457 that would extend
from the JIIMS, NJ, WP to the BOOCH, PA, WP.
    T-459: This action proposes a new route T-459 that would extend
from the JIIMS, NJ, WP to the DOGGR, PA, WP.
    T-476: This action proposes a new route T-476 that would extend
from the TUNDR, MD, WP to the WIMKA, NJ, WP.

Regulatory Notices and Analyses

    The FAA has determined that this proposed 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. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F: ``nvironmental Impacts: Policies and
Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-358 Martinsburg, WV (MRB) to Augusta, ME (AUG) [Amended]

Martinsburg, WV (MRB)           VORTAC             (Lat. 39[deg]23'08.06'' N, long. 077[deg]50'54.08'' W)
CPTAL, MD                       WP                 (Lat. 39[deg]32'16.02'' N, long. 077[deg]41'55.65'' W)
TWIRK, MD                       WP                 (Lat. 39[deg]34'36.70'' N, long. 077[deg]12'44.75'' W)
HAMRR, MD                       WP                 (Lat. 39[deg]30'03.42'' N, long. 076[deg]56'10.84'' W)
DANII, MD                       WP                 (Lat. 39[deg]17'46.42'' N, long. 076[deg]42'19.36'' W)
OBWON, MD                       WP                 (Lat. 39[deg]11'54.69'' N, long. 076[deg]32'04.84'' W)
SWANN, MD                       WP                 (Lat. 39[deg]09'05.28'' N, long. 076[deg]13'43.94'' W)
Smyrna, DE (ENO)                VORTAC             (Lat. 39[deg]13'53.93'' N, long. 075[deg]30'57.49'' W)
AVALO, NJ                       WP                 (Lat. 39[deg]16'54.52'' N, long. 074[deg]30'50.75'' W)
MANTA, NJ                       WP                 (Lat. 39[deg]54'07.01'' N, long. 073[deg]32'31.63'' W)
ORCHA, NY                       WP                 (Lat. 40[deg]54'55.46'' N, long. 072[deg]18'43.64'' W)
Sandy Point, RI (SEY)           VOR/DME            (Lat. 41[deg]10'02.77'' N, long. 071[deg]34'33.91'' W)
BURDY, MA                       WP                 (Lat. 41[deg]57'19.14'' N, long. 070[deg]57'07.45'' W)
HAVNS, OA                       WP                 (Lat. 42[deg]17'55.00'' N, long. 070[deg]27'42.00'' W)
GRGIO, MA                       WP                 (Lat. 42[deg]35'09.36'' N, long. 070[deg]33'54.40'' W)
LBSTA, MA                       WP                 (Lat. 42[deg]48'00.00'' N, long. 070[deg]36'48.70'' W)
MESHL, ME                       WP                 (Lat. 43[deg]19'12.07'' N, long. 070[deg]09'48.03'' W)
Augusta, ME (AUG)               VOR/DME            (Lat. 44[deg]19'12.07'' N, long. 069[deg]47'47.63'' W)

                                                 * * * * * * *
T-416 Smyrna, NJ (ENO) to PREPI, OA [Amended]

Smyrna, NJ (ENO)                VORTAC             (Lat. 39[deg]13'53.93'' N, long. 075[deg]30'57.49'' W)
TEBEE, NJ                       WP                 (Lat. 39[deg]30'13.97'' N, long. 075[deg]19'37.19'' W)
LULOO, NJ                       WP                 (Lat. 39[deg]36'35.96'' N, long. 075[deg]12'57.43'' W)
RIDNG, NJ                       WP                 (Lat. 39[deg]43'56.08'' N, long. 075[deg]07'12.86'' W)
ALBEK, NJ                       WP                 (Lat. 39[deg]46'39.92'' N, long. 074[deg]54'25.99'' W)
Coyle, NJ (CYN)                 VORTAC             (Lat. 39[deg]49'02.42'' N, long. 074[deg]25'53.85'' W)
PREPI, OA                       WP                 (Lat. 39[deg]48'41.06'' N, long. 073[deg]15'40.70'' W)

                                                 * * * * * * *
T-440 Elmira, NY (ULW) to TALLI, PA [New]

Elmira, NY (ULW)                VOR/DME            (Lat. 42[deg]05'38.96'' N, long. 077[deg]01'29.30'' W)
WLKES, PA                       WP                 (Lat. 41[deg]16'22.57'' N, long. 075[deg]41'21.60'' W)
TALLI, PA                       WP                 (Lat. 41[deg]19'01.60'' N, long. 075[deg]06'43.17'' W)

                                                 * * * * * * *
T-445 Harrisburg, PA (HAR) to AIRCO, NY [Amended]

Harrisburg, PA (HAR)            VORTAC             (Lat. 40[deg]18'08.06'' N, long. 077[deg]04'10.41'' W)
Selinsgrove, PA (SEG)           VOR/DME            (Lat. 40[deg]47'27.09'' N, long. 076[deg]53'02.55'' W)
LYKOM, PA                       WP                 (Lat. 41[deg]20'18.75'' N, long. 076[deg]46'30.30'' W)
Elmira, NY (ULW)                VOR/DME            (Lat. 42[deg]05'38.96'' N, long. 077[deg]01'29.32'' W)
BEEPS, NY                       WP                 (Lat. 42[deg]49'13.26'' N, long. 076[deg]59'04.84'' W)
Rochester, NY (ROC)             VOR/DME            (Lat. 43[deg]07'04.65'' N, long. 077[deg]40'22.06'' W)
AIRCO, NY                       WP                 (Lat. 43[deg]12'36.66'' N, long. 078[deg]28'57.00'' W)

                                                 * * * * * * *
T-455 Allentown, PA (FJC) to WIGGZ, PA [New]

Allentown, PA (FJC)             VORTAC             (Lat. 40[deg]43'36.07'' N, long. 075[deg]27'17.08'' W)
WLKES, PA                       WP                 (Lat. 41[deg]16'22.57'' N, long. 075[deg]41'21.60'' W)
LYKOM, PA                       WP                 (Lat. 41[deg]20'18.75'' N, long. 076[deg]46'30.30'' W)
WIGGZ, PA                       WP                 (Lat. 41[deg]30'51.00'' N, long. 077[deg]58'52.00'' W)

                                                 * * * * * * *
T-457 JIMMS, NJ to BOOCH, PA [New]

JIIMS, NJ                       WP                 (Lat. 39[deg]32'15.62'' N, long. 074[deg]58'01.72'' W)
GABRS, NJ                       WP                 (Lat. 39[deg]38'15.91'' N, long. 075[deg]04'15.96'' W)
RIDNG, NJ                       WP                 (Lat. 39[deg]43'56.08'' N, long. 075[deg]07'12.86'' W)
BOJID, PA                       WP                 (Lat. 40[deg]03'20.87'' N, long. 075[deg]12'16.25'' W)
BOOCH, PA                       WP                 (Lat. 40[deg]14'09.24'' N, long. 075[deg]16'08.52'' W)

                                                 * * * * * * *
T-459 JIIMS, NJ to DOGGR, PA [New]

JIIMS, NJ                       WP                 (Lat. 39[deg]32'15.62'' N, long. 074[deg]58'01.72'' W)
LULOO, NJ                       WP                 (Lat. 39[deg]36'35.96'' N, long. 075[deg]12'57.43'' W)
DOGGR, PA                       WP                 (Lat. 40[deg]08'12.25'' N, long. 075[deg]27'07.50'' W)

                                                 * * * * * * *
T-476 TUNDR, MD to WIMKA, NJ [New]

TUNDR, MD                       WP                 (Lat. 38[deg]44'37.73'' N, long. 076[deg]15'38.97'' W)
FILRO, MD                       WP                 (Lat. 38[deg]57'51.42'' N, long. 075[deg]56'45.51'' W)
TWANE, MD                       WP                 (Lat. 39[deg]10'57.10'' N, long. 075[deg]57'34.19'' W)
EYEUP, MD                       WP                 (Lat. 39[deg]18'30.83'' N, long. 075[deg]51'56.10'' W)
COHLE, DE                       WP                 (Lat. 39[deg]20'26.55'' N, long. 075[deg]34'36.79'' W)
WIMKA, NJ                       WP                 (Lat. 39[deg]25'22.02'' N, long. 075[deg]08'32.67'' W)

                                                  * * * * * * *

    Issued in Washington, DC, on June 1, 2023.
Brian Konie,
Acting Manager, Airspace Rules and Regulations.
[FR Doc. 2023-12090 Filed 6-6-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 55 (Wednesday, March 24, 2021)]
[Rules and Regulations]
[Pages 15576-15579]
[FR Doc No: 2021-06200]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0194; Project Identifier MCAI-2020-01434-R;
Amendment 39-21482; AD 2021-07-05]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.a. (Type Certificate
Previously Held by Agusta S.p.A.) (Leonardo) Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2007-26-52
which applied to certain Agusta S.p.A. (now Leonardo) Model A109C,
A109E, and A109K2 helicopters. AD 2007-26-52 required inspecting for
swelling, deformation, bonding separation, and for a crack on each main
rotor blade (MRB) with a certain part-numbered tip cap installed, and
removing the MRB from service before further flight if any of these
conditions exist and exceed the prescribed limits. This AD retains all
inspections for certain serial-numbered MRBs, but for MRBs with a
certain tip cap installed, this AD requires dye-penetrant inspections
rather than visual inspections. This AD was prompted by additional
reports of in-flight loss of part of a tip cap. The FAA is issuing this
AD to address the unsafe condition on these products.

DATES: This AD becomes effective April 8, 2021.
    The Director of the Federal Register approved the incorporation by
reference of certain documents listed in this AD as of April 8, 2021.
    The Director of the Federal Register approved the incorporation by
reference of certain other documents listed in this AD as of January 7,
2002 (66 FR 60144, December 3, 2001).
    The FAA must receive comments on this AD by May 10, 2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For Agusta and Leonardo Helicopters service information identified
in this final rule, contact Leonardo S.p.a. Helicopters, Emanuele
Bufano, Head of Airworthiness, Viale G.Agusta 520, 21017 C.Costa di
Samarate (Va) Italy; telephone +39-0331-225074; fax +39-0331-229046; or
at https://www.leonardocompany.com/en/home. You may view this service
information at the FAA, Office of the Regional Counsel, Southwest
Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For
information on the availability of this material at the FAA, call (817)
222-5110. It is also available at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0194.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0194; 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 final rule, the
European Union Aviation Safety Agency (EASA) AD, any comments received,
and other information. The street address for Docket Operations is
listed above.

FOR FURTHER INFORMATION CONTACT: Fred Guerin, Aerospace Engineer,
General Aviation & Rotorcraft Section, International Validation Branch,
FAA, 2200 South 216th St., Des Moines, WA 98198; telephone (206) 231-
3500; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The FAA issued Emergency AD 2007-26-52 on December 20, 2007 and
published it as a Final rule; request for comments on May 9, 2008, as
Amendment 39-15519 (73 FR 26316). AD 2007-26-52 applied to Agusta
S.p.A. (now Leonardo) Model A109C, A109E, and A109K2 helicopters with
an MRB part number (P/N) 709-0103-01-all dash numbers installed. AD
2007-26-52 required, for any MRB with a serial number (S/N) with a
prefix of either ``EM-'' or ``A5-'', except a MRB with a tip cap P/N
709-0103-29-109, within 10 hours time-in-service (TIS) and thereafter
at intervals not to exceed 25 hours TIS:
     A tap inspection of the upper and lower sides of each tip
cap and in the tip cap to blade bond area for bonding separation;
     A visual inspection of the upper and lower side of each
blade tip cap for swelling or deformation; and
     A dye-penetrant inspection of the tip cap leading edge
along the welded joint line of the upper and lower tip cap skin shells
for a crack.
    For any MRB with a tip cap P/N 709-0103-29-109 installed, the AD
required visually inspecting for a crack on the leading edge at the
welded bead (joint line of shells) using a 10x or higher power
magnifying glass, and if there is damage other than a crack, inspecting
the area using a dye-penetrant inspection method, within the following
compliance times:
     For a tip cap P/N 709-0103-29-109 with 600 or more hours
TIS, inspect within the next 5 hours TIS or 30 days, whichever occurs
first, and thereafter at intervals not to exceed 50 hours TIS; or
     For a tip cap P/N 709-0103-29-109 with less than 600 hours
TIS, inspect before reaching 600 hours TIS, and thereafter, at
intervals not to exceed 50 hours TIS.
    AD 2007-26-52 also required replacing the MRB if swelling,
deformation, a crack, or bonding separation that exceeds the prescribed
limits is found in an MRB with an affected prefix, except an MRB with a
tip cap P/N 709-0103-29-109. The MRB must be replaced with an airworthy
MRB before further flight. If a crack is found in a MRB with tip cap P/
N 709-0103-29-109, then AD 2007-26-52 required replacing the MRB before
further flight. The actions were required to be accomplished in
accordance with the manufacturer's service information.
    AD 2007-26-52 was prompted by EASA AD 2007-0306-E, dated December
14, 2007 (EASA AD 2007-0306-E). EASA, which is the Technical Agent for
the Member States of the European Union, notified the FAA that an
unsafe condition may exist on Agusta Model A109C, A109E, and A109K2
helicopters. EASA advises that an incident occurred in which a Model
A109E helicopter lost part of the tip of the MRB due to fracture of the
welded bead (joint line of shells). The manufacturer advised that the
investigation relating to this tip cap failure was still ongoing.

Actions Since AD 2007-26-52 Was Issued

    Since the FAA issued AD 2007-26-52, EASA issued AD 2020-0230, dated
October 22, 2020 (EASA AD 2020-0230), which supersedes EASA AD 2007-
0306-E, to correct an unsafe condition for Leonardo S.p.a. Helicopters,
formerly Finmeccanica S.p.A., AgustaWestland S.p.A., Agusta

S.p.A., Model A109E, A109K2, and A109C helicopters, all serial numbers.
EASA advises that recent occurrences of affected parts detachment have
been reported. EASA advises that the visual inspection for MRBs with
tip cap P/N 709-0103-29-109 installed is no longer acceptable to detect
part cracking and that this condition, if not detected and corrected,
could lead to further affected parts detachments, possibly resulting in
reduced control of the helicopter.
    Accordingly, EASA AD 2020-0230 replaces the requirements of EASA AD
2007-0306-E for MRBs with a tip cap P/N 709-0103-29-109 installed, by
changing the visual inspections of affected parts to dye-penetrant
inspections and requires, depending on findings, replacement.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA is issuing this AD after
evaluating all known relevant information and determining that the
unsafe condition described previously is likely to exist or develop on
other helicopters of the same type designs.

Related Service Information Under 1 CFR Part 51

    The FAA previously reviewed the following Agusta Alert Bollettino
Tecnicos (BT), each Revision B and each dated December 19, 2000:
     No. 109-106 which applies to Model A109C helicopters;
     No. 109EP-1 which applies to Model A109E helicopters; and
     No. 109K-22 which applies to Model A109K2 helicopters.
    These BTs specify procedures for inspecting the MRB tip cap for
bonding separation and a crack; a tap inspection of the tip cap for
bonding separation in the blade bond; and a dye-penetrant inspection of
the tip cap leading edge along the welded joint line of the upper and
lower tip cap skin shells for a crack.
    The FAA reviewed the following Leonardo Helicopters Alert Service
Bulletins (ASBs), each Revision A and each dated October 19, 2020:
     No. 109-125 which applies to Model A109C helicopters;
     No. 109EP-085 which applies to Model A109E helicopters;
and
     No. 109K-048 which applies to Model A109K2 helicopters.
    These ASBs specify dye-penetrant inspecting the tip cap P/N 709-
0103-29-109 for cracks on the tip cap leading edge at the welded bead
(joint line of shells) and removes the magnifying glass inspection that
was specified in the original ASBs.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

AD Requirements

    This AD continues to require, for an MRB with a S/N that has a
prefix of either ``EM-'' or ``A5-'', except an MRB with a tip cap P/N
709-0103-29-109 installed, within 10 hours TIS after the effective date
of this AD and thereafter at intervals not to exceed 25 hours TIS, tap
inspecting each tip cap for bonding separation in specified areas; tap
inspecting for bonding separation in the tip cap to blade bond area;
visually inspecting the upper and lower sides of each blade tip cap for
swelling or deformation; and dye-penetrant inspecting the tip cap
leading edge along the welded joint line of the upper and lower tip cap
skin shells for a crack. If there is any swelling, deformation, or
crack, or bonding separation that exceeds allowable limits, removing
the blade from service is required before further flight; if there is
no swelling, deformation or crack, or if bonding separation does not
exceed allowable limits, continuing the inspections is required.
    For an MRB with a tip cap P/N 709-0103-29-109 installed, this AD
now requires, for each tip cap with less than 600 hours TIS, before
reaching 600 hours TIS, and thereafter, at intervals not to exceed 50
hours TIS, or for each tip cap with 600 or more hours TIS, within the
next 5 hours TIS or 30 days after the effective date of this AD,
whichever occurs first, and thereafter at intervals not to exceed 50
hours TIS, dye-penetrant inspecting the welded bead on the tip cap
leading edge (joint line between the two metal shells) for a crack and
removing the tip cap from service if there is a crack.
    This AD also prohibits installing an MRB with tip cap P/N 709-0103-
29-109 on any helicopter unless it has been inspected in accordance
with the inspection requirements of this AD.

Justification for Immediate Adoption and Determination of the Effective
Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies foregoing notice and comment prior to adoption of this rule
because inspections for certain MRBs must be accomplished within 5 or
10 hours TIS after the effective date of this AD, depending on the MRB,
and corrective action is required before further flight. Accordingly,
notice and opportunity for prior public comment are impracticable and
contrary to the public interest pursuant to 5 U.S.C. 553(b)(3)(B). In
addition, the FAA finds that good cause exists pursuant to 5 U.S.C.
553(d) for making this amendment effective in less than 30 days, for
the same reasons the FAA found good cause to forego notice and comment.

Comments Invited

    The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2021-0194; Project Identifier MCAI-
2020-01434-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, 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 final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this final rule.

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 AD 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 AD, 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 AD. Submissions
containing CBI should be sent to Fred Guerin, Aerospace Engineer,
General Aviation & Rotorcraft Section, International Validation Branch,
FAA, 2200 South 216th St., Des Moines, WA 98198; telephone (206) 231-
3500; email<EMAIL_ADDRESS>Any commentary that the FAA receives
which is not specifically designated as CBI will be placed in the
public docket for this rulemaking.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because the FAA has determined
that it has good cause to adopt this rule without prior notice and
comment, RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 72 helicopters of U.S.
Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates the following costs to comply with
this AD.
    Each tap inspection will take about 3 work-hours and there are no
parts costs for an estimated cost of about $255 per helicopter per
inspection cycle.
    Each visual inspection will take about 1 work-hour and there are no
parts cost for an estimated cost of about $85 per helicopter per
inspection cycle.
    Each dye-penetrant inspection will take about 3 work-hours and
parts will cost about $100 for an estimated cost of about $355 per
helicopter per inspection cycle.
    Replacing a blade, if required, will take about 2 work-hours and
parts will cost about $98,435 per blade, for an estimated cost of about
$98,605 per replacement.
    Replacing a tip cap, if required, will take about 30 work-hours and
parts will cost about $3,034 per tip cap, for an estimated cost of
about $5,584 per replacement.
    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some of the costs of this 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

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national Government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) 2007-26-52, Amendment 39-15519
(73 FR 26316, May 9, 2008); and
0
b. Adding the following new AD:

2021-07-05 Leonardo S.p.a. (Type Certificate Previously Held by
Agusta S.p.A.) (Leonardo): Amendment 39-21482; Docket No. FAA-2021-
0194; Project Identifier MCAI-2020-01434-R.

(a) Effective Date

    This airworthiness directive (AD) is effective April 8, 2021.

(b) Affected ADs

    This AD replaces AD 2007-26-52, Amendment 39-15519 (73 FR 26316,
May 9, 2008).

(c) Applicability

    This AD applies to Leonardo Model A109C, A109E, and A109K2
helicopters, certificated in any category, with a main rotor blade
(MRB) part number (P/N) 709-0103-01-all dash numbers installed.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 6210, Main Rotor
Blades.

(e) Unsafe Condition

    This AD was prompted by reports of the in-flight loss of tip
caps. The FAA is issuing this AD to prevent loss of a tip cap from
an MRB. The unsafe condition, if not addressed, could result in an
increase in MRB vibration and subsequent loss of control of the
helicopter.

(f) Compliance

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

(g) Required Actions

    (1) For an MRB with a serial number that has a prefix of either
``EM-'' or ``A5-'', except an MRB with a tip cap P/N 709-0103-29-109
installed, within 10 hours time-in-service (TIS) after the effective
date of this AD, unless accomplished previously, and thereafter at
intervals not to exceed 25 hours TIS:
    (i) Tap inspect the upper and lower sides of each tip cap for
bonding separation between the metal shells and the honeycomb core
using a steel hammer P/N 109-3101-58-1 or a coin (quarter) in the
area indicated as honeycomb core on Figure 1 of Agusta Alert
Bollettino Tecnico (BT) No. 109-106, BT No. 109K-22, or BT No.
109EP-1, each Revision B and each dated December 19, 2000 (BT No.
109-106, BT No. 109K-22, or BT No. 109EP-1), as applicable to your
helicopter model. Also, tap inspect for bonding separation in the
tip cap to blade bond area (no bonding voids are permitted in this
area).
    (ii) Visually inspect the upper and lower sides of each blade
tip cap for swelling or deformation.
    (iii) Dye-penetrant inspect the tip cap leading edge along the
welded joint line of the upper and lower tip cap skin shells for a
crack in accordance with the Compliance Instructions, steps 3.
through 3.2.6., of BT No. 109-106, BT No. 109K-22, or BT No. 109EP-
1, as applicable to your helicopter model.
    (iv) If there is any swelling, deformation, or crack; or bonding
separation that exceeds

allowable limits, remove the blade from service before further
flight.
    (v) If there is no swelling, deformation or crack; or if bonding
separation does not exceed allowable limits, continue to perform the
inspections required by this AD.
    (2) For an MRB with a tip cap P/N 709-0103-29-109 installed,
perform the following at the specified intervals:
    (i) For each tip cap with less than 600 hours TIS, before
reaching 600 hours TIS, and thereafter, at intervals not to exceed
50 hours TIS or
    (ii) For each tip cap with 600 or more hours TIS, within the
next 5 hours TIS or 30 days after the effective date of this AD,
whichever occurs first, and thereafter at intervals not to exceed 50
hours TIS.
    (A) Dye-penetrant inspect the welded bead on the tip cap leading
edge (joint line between the two metal shells) for a crack in
accordance with the Accomplishment Instructions, steps 3.1 through
3.6, of Leonardo Helicopters Alert Service Bulletin (ASB) No. 109-
125, ASB No. 109EP-085, or ASB No. 109K-048, each at Revision A and
each dated October 19, 2020, as applicable your helicopter model.
    (B) If there is a crack, remove the tip cap from service before
further flight.
    (3) As of the effective date of this AD, do not install any MRB
with tip cap P/N 709-0103-29-109 on any helicopter unless it has
been inspected in accordance with the inspection requirements of
this AD.

(h) Special Flight Permits

    Special flight permits may be issued in accordance with 14 CFR
21.197 and 21.199 to operate the helicopter to a location where the
requirements of this AD can be accomplished provided that:
    (1) No passengers are onboard;
    (2) The time to fly to the location does not exceed 10 hours
TIS; and
    (3) The airspeed does not exceed 70 knots indicated air speed
(KIAS).

(i) Alternative Methods of Compliance (AMOCs)

    (1) 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 local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (j)(1) of
this AD. Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    (1) For more information about this AD, contact Fred Guerin,
Aerospace Engineer, General Aviation & Rotorcraft Section,
International Validation Branch, FAA, 2200 South 216th St., Des
Moines, WA 98198; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (2) The subject of this AD is addressed in European Union
Aviation Safety Agency (EASA) AD 2020-0230, dated October 22, 2020.
You may view the EASA AD on the internet at https://www.regulations.gov in Docket No. FAA-2021-0194.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (3) The following service information was approved for IBR on
April 8, 2021.
    (i) Leonardo Helicopters Alert Service Bulletin No. 109-125,
Revision A, dated October 19, 2020.
    (ii) Leonardo Helicopters Alert Service Bulletin No. 109EP-085,
Revision A, dated October 19, 2020.
    (iii) Leonardo Helicopters Alert Service Bulletin No. 109K-048,
Revision A, dated October 19, 2020.
    (4) The following service information was approved for IBR on
January 7, 2002 (66 FR 60144, December 3, 2001).
    (i) Agusta Alert Bollettino Tecnico No. 109-106, Revision B,
dated December 19, 2000.
    (ii) Agusta Alert Bollettino Tecnico No. 109EP-1, Revision B,
dated December 19, 2000.
    (iii) Agusta Alert Bollettino Tecnico No. 109K-22, Revision B,
dated December 9, 2000.
    (5) For Leonardo Helicopters and Agusta service information
identified in this AD, contact Leonardo S.p.a. Helicopters, Emanuele
Bufano, Head of Airworthiness, Viale G. Agusta 520, 21017 C. Costa
di Samarate (Va) Italy; telephone +39-0331-225074; fax +39-0331-
229046; or at https://www.leonardocompany.com/en/home.
    (6) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (7) 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_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on March 19, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-06200 Filed 3-22-21; 4:15 pm]
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[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Pages 66746-66747]
[FR Doc No: 2013-26547]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1021]

Medical Device User Fee and Modernization Act; Notice to Public
of Web Site Location of Fiscal Year 2014 Proposed Guidance Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the Web site location where the Agency will post two lists
of guidance documents the Center for Devices and Radiological Health
(CDRH) is intending to publish in Fiscal Year (FY) 2014. In addition,
FDA has established a docket where stakeholders may provide comments
and/or propose draft language for those topics, suggest new or
different guidance documents, and comment on the priority of topics for
guidance.

DATES: Submit either electronic or written comments at any time.

ADDRESSES: Submit electronic comments on the proposed guidance to
http://www.regulations.gov. Submit written comments to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Philip Desjardins, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5452, Silver Spring, MD 20993-0002, 301-
796-5678.

SUPPLEMENTARY INFORMATION:

I. Background

    During negotiations over the Medical Device User Fee Amendments of
2012 (MDUFA III), Title II, Food and Drug Administration Safety and
Innovation Act (Pub. L. 112-144), FDA agreed, in return for additional
funding from industry, to meet a variety of quantitative and
qualitative goals intended to help get safe and effective medical
devices to market more quickly. These commitments include annually
posting a list of prioritized medical device guidance documents that
the Agency intends to publish within 12 months of the date this list is
published each fiscal year (the ``A-list'') and a list of device
guidance documents that the Agency intends to publish, as the Agency's
guidance-development resources permit each fiscal year (the ``B-
list''). In addition to posting lists of prioritized device guidance
documents, FDA has committed to updating its Web site in a timely
manner to reflect the Agency's review of previously published guidance
documents, including the deletion of guidance documents that no longer
represent the Agency's interpretation of, or policy on, a regulatory
issue, and notation of guidance documents that are under review by the
Agency. Fulfillment of this commitment will be reflected through the
issuance of updated guidance on existing topics, removal of guidances
that that no longer reflect FDA's current thinking on a particular
topic, and annual updates to the A-list and B-list announced in this
notice.
    This notice announces the Web site location of the two lists of
guidance documents which CDRH is intending to publish during FY 2014.
We note that the Agency is not required to publish every guidance on
either list if the resources needed would be to the detriment of
meeting quantitative review timelines and statutory obligations. The
Agency is not precluded from issuing guidance documents that are not on
either list.
    FDA and CDRH priorities are subject to change at any time. Topics
on this and past guidance priority lists may be removed or modified
based on current priorities. CDRH's experience in guidance development
has shown that there are many reasons that CDRH staff may not complete
the entire agenda of guidances it undertakes. Staffs are frequently
diverted from guidance development to other priority activities. In
addition, at any time new issues may arise to be addressed in guidance
that could not have been anticipated at the time the annual list is
generated. These may involve newly identified public health issues.
    FDA anticipates that feedback from stakeholders, including draft
language for guidance documents, will allow CDRH to better prioritize
and more efficiently draft guidances that will be useful to industry
and other stakeholders. FDA intends to update the list each year.
    FDA invites interested persons to submit comments on any or all of
the guidance documents on the lists. FDA has established a docket where
comments on the FY 2014 lists, draft language for guidance documents on
those topics, suggestions for new or different guidances, and relative
priority of guidance documents may be submitted (see ADDRESSES). FDA
believes this docket is an important tool for receiving information
from interested parties and for sharing this information with the
public. Similar information about planned guidance development is
included in the annual Agency-wide notice issued under its good
guidance practices (21 CFR 10.115(f)(5)). The CDRH lists, however, will
be focused exclusively on device-related guidances and will be made
available on FDA's Web site at the beginning of each FY from 2013 to
2017. To access the lists of guidance documents CDRH is intending to
publish in FY 2014, visit FDA's Web site http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/ucm321367.htm.

II. Request for Comments

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

    Dated: October 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26547 Filed 11-5-13; 8:45 am]
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