[Federal Register: February 8, 2006 (Volume 71, Number 26)]
[Rules and Regulations]
[Page 6356-6359]
[DOCID:fr08fe06-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0508; FRL-7755-8]

Imazethapyr; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an increase in tolerances for the
sum of the residues of imazethapyr and its metabolites, CL 288511, (2-
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-(1-
hydroxyethyl)-3-pyridine carboxylic acid), and CL 182704, (5-[1-(beta-
D-glucopyranosyloxy)ethyl]-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-
oxo-1H-imidazol-2-yl]-3-pyridinecarboxylic acid), applied as its acid
or ammonium salt in or on rice grain at 0.3 ppm, rice straw at 0.4 ppm,
and imazethapyr and its metabolite, CL 288511 in or on crayfish at 0.15
ppm. BASF Corporation requested the tolerances for rice grain and rice
straw under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA), because of a
requested increase in the use rate of imazethapyr in rice. In addition,
this regulation increases the tolerance on crayfish from 0.10 ppm to
0.15 ppm due to exposure of crayfish raised in rice fields to
imazethapyr.

DATES: This regulation is effective February 8, 2006. Objections and
requests for hearings must be received on or before April 10, 2006.

ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number EPA-HQ-OPP-2005-0508. All documents in the
docket are listed on the http://www.regulations.gov web site. (EDOCKET, EPA's

electronic public docket and comment system was replaced on November
25, 2005, by an enhanced Federal-wide electronic docket management and
comment system located at http://www.regulations.gov/. Follow the on-

line instructions.) Although listed in the index, some information is
not publicly available, i.e., 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 in EDOCKET or in hard copy at the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: James A. Tompkins, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail 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.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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 Access Electronic Copies of this Document and Other
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may

access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
 A frequently updated electronic version of 40 CFR part 180

is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In the Federal Register of June 29, 2005 (70 FR 37392) (FRL-7718-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5F
6947) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, North Carolina 27709-3528. The petition requested that
40 CFR 180.447 be amended by establishing a tolerance for the sum of
the residues of the herbicide Imazethapyr, and its metabolites CL
288511 and CL182704, in or on rice grain at 0.3 parts per million
(ppm), and rice straw at 0.4 ppm. That notice included a summary of the
petition prepared by BASF Corporation, the registrant. Comments were
received on the notice of filing. EPA's response to these comments is
discussed in Unit IV.C.
    In addition, after completion of the dietary risk analysis for
imazethapyr residues on rice, the Agency determined that the tolerance
for combined residues for imazethapyr and the metabolite CL 288511 in
crayfish needs to be increased from 0.10 ppm to 0.15 ppm. Crayfish are
often raised in flooded rice fields, and thus are exposed to residues
of pesticides that are applied to rice.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(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 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 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. . . .''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerances for the sum of the residues of
imazethapyr and its metabolites CL 288511 and CL 182704 on rice grain
at 0.3 ppm, rice straw at 0.4 ppm, and for the sum of residues of
imazethapyr and its metabolite 288511 in crayfish at 0.15 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. The nature of the toxic effects caused by imazethapyr are
discussed in Unit III.A. of the final rule that established imazethapyr
tolerances in or on rice, crayfish, and meat byproducts of certain
cattle (FR notice dated August 29, 2002, 67 FR 55323, FRL-7193-4).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides.

    A summary of the toxicological endpoints for imazethapyr used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of (FR notice dated August 29, 2002,
67 FR 55323).

C. Exposure Assessment

    The Registrant, BASF Corporation, has requested an amended
registration to increase the use rate of, 2-[4,5-dihydro-4-methyl-4-(1-
methylethyl)-5-oxo-1H-imidazol-2-yl]-5-ethyl-3-pyridine carboxylic acid
from 0.125 lbs acid equivalent (ae)/application/acre/crop season and a
45-day preharvest interval (PHI) to 0.188 lbs ae/application/acre per
crop season and an 85-day PHI.
    The dietary exposure for all populations continues to be < 1%
chronic population adjusted dose (cPAD) with the minor changes in
tolerances for rice grain and straw, and crayfish established in this
Federal Register Notice. The exposure assessment for imazethapyr is
discussed in Unit III.C. of the final rule that established the
original imazethapyr tolerances in or on rice, crayfish, and meat
byproducts of certain cattle (FR notice dated August 29, 2002, 67 FR
55323). In this action, the tolerances for rice grain are increased
from 0.2 ppm to 0.3 ppm, for rice straw are increased from 0.15 ppm to
0.4 ppm) and in crayfish are increased from 0.10 ppm to 0.15 ppm. These
increases resulted in an increase in dietary exposure for the general
population from 0.000393 milligram/kilogram/day (mg/kg/day) to 0.002367
mg/kg/day, which is still much less than 1% of the cPAD of 2.5 mg/kg/
day. The highest dietary exposure as a result of the increased
tolerances is 0.008824 mg/kg/day for non-nursing infants, which is also
less than 1% of the cPAD. (Since dietary exposure for non-nursing
infants was not calculated separately in the previous dietary
assessment, but was included as part of all infants, there is no
meaningful comparison to previous dietary risk exposures.)

D. Safety Factor for Infants and Children

    The safety factors for infants and children for imazethapyr are
discussed in Unit III.D. of the final rule that established imazethapyr
tolerances in or on rice, crayfish, and meat byproducts of certain
cattle (FR notice dated August 29, 2002, 67 FR 55323).

E. Aggregate Risks and Determination of Safety

    The aggregate risks and determination of safety for imazethapyr are
discussed in Unit III.E. of the final rule that established imazethapyr
tolerances in or on rice, crayfish, and meat byproducts of certain
cattle (notice dated August 29, 2002, 67 FR 55323). Based on these risk
assessments, EPA concludes that there is a reasonable certainty that no
harm will result to the general population, and to infants and children
from aggregate exposure to imazethapyr residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The enforcement method for use on rice grain and rice straw is
Method M3120. This method measures the concentrations of imazethapyr
and its metabolites CL 288511 and CL 182704. The method extracts
residues with acidic aqueous methanol, and the extract is then eluted
through C18, strong anion exchange, and strong cation exchange columns.
Residues are quantified via capillary electrophoresis with a UV
detector.
    The enforcement method for use on crayfish is Method 3512. This
method quantifies the residues for imazethapyr and its metabolite CL
299511. This method involves extraction of residues using acidic
acetone, followed by elution through a C18 column, and residues are
quantified using LC/MS analysis. The enforcement methods may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    There are no Codex maximum residue levels established or proposed
for residues of imazethapyr on rice.

C. Response to Comments

    Public comments were received from B. Sachau. She objected that the
several of the proposed tolerances levels, including the level for
chicken, are too high. She questions who performed the tests showing
these levels are necessary and whether EPA checked the tests. Ms.
Sachau also objected to the use of animal testing, and the use of food
intake survey data from 1994.
    Response: EPA requires that petitioners submit data from studies on
residue levels in treated crops and in animals that consume treated
crops. Such studies are performed according to established protocols
and EPA carefully examines the data from the studies after it is
submitted. That was done with regard to the tolerance levels for
imazethapyr. It is noted that imazethapyr tolerances in chicken are not
being increased by this action. EPA has responded to B. Sachau's
generalized comments, in including her generalized objections to animal
testing, on numerous previous occasions (see January 7, 2005, 70 FR
1349, 1354, FRL-7691-4); (October 29, 2004, 69 FR 63083, 63096, FRL-
7681-9). As to her claim that food consumption data from 1994 is out of
date, EPA would note that the food consumption data relied upon was
collected between 1994 and 1998 by the United States Department of
Agriculture (USDA) in there (Continuing Survey of Food Intakes by
Individuals (CSFII)). Generally, major surveys of consumption patterns
have been conducted by the USDA every 5 to 10 years or so. EPA has
found that changes between surveys are on the margin and EPA has no
reason to believe that there have been significant shifts in food
consumption patterns in the last several years. B. Sachau's comments
contained no scientific data or evidence to rebut the Agency's
conclusion that there is a reasonable certainty that no harm will
result from aggregate exposure to imazethapyr, including all
anticipated dietary exposures and all other exposures for which there
is reliable information.

V. Conclusion

    Therefore, tolerances are established for the sum of the residues
of imazethapyr, and its metabolites CL 288511 and CL 182704, in or on
rice, grain at 0.3 ppm, and rice, straw at 0.4 ppm and for the sum of
the residues of imazethapyr and its metabolite CL 288511 in or on
crayfish at 0.15 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify ID number EPA-HQ-OPP-2005-0508 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before April 10,
2006.
    1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issue(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is<PHONE_NUMBER>.
    2. Copies for the EPA. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number EPA-HQ-OPP-2005-0508, to: Public
Information and Records Integrity Branch, Information Technology and
Resource Management Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. In person or by courier, bring a copy to the
location of the PIRIB described in ADDRESSES. You may also send an
electronic copy of your request via e-mail to<EMAIL_ADDRESS>Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issue(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA 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 rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,

Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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 of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive Order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of FFDCA. For these same reasons, the
Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.

VIII. Congressional Review Act

    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 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 this final rule in the Federal Register. This final
rule 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: January 25, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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. Section 180.447 is amended by increasing the tolerance level for the
following commodities in the tables in paragraphs (a)(2) and (a)(3) to
read as follows:

Sec.  180.447  Imazethapyr; tolerances for residues.

    (a)(1) * * *
    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Rice, grain................................................          0.3
Rice, straw................................................          0.4
------------------------------------------------------------------------

    (3)* * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Crayfish...................................................         0.15
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 06-1036 Filed 2-7-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 87, Number 203 (Friday, October 21, 2022)]
[Rules and Regulations]
[Pages 63943-63946]
[FR Doc No: 2022-22333]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0011; Project Identifier MCAI-2021-00485-T;
Amendment 39-22166; AD 2022-18-15]
RIN 2120-AA64

Airworthiness Directives; MHI RJ Aviation ULC (Type Certificate
Previously Held by Bombardier, Inc.) Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain MHI RJ Aviation ULC Model CL-600-2B19 (Regional Jet Series 100
& 440) airplanes, Model CL-600-2C10 (Regional Jet Series 700, 701 &
702) airplanes, Model CL-600-2C11 (Regional Jet Series 550) airplanes,
Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-
2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25
(Regional Jet Series 1000) airplanes. This AD was prompted by reports
of corrosion on fuel clamshell couplings installed in the fuel tank,
and a determination that new or more restrictive airworthiness
limitations are necessary. This AD requires removing and replacing the
fuel clamshell couplings on certain airplanes, and revising the
existing maintenance or inspection program, as applicable, to
incorporate new or more restrictive airworthiness limitations. The FAA
is issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective November 25, 2022.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of November 25,
2022.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-0011; 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 mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For service information identified in this final rule,
contact MHI RJ Aviation Group, Customer Response Center, 3655 Ave. des
Grandes-Tourelles, Suite 110, Boisbriand, Qu[eacute]bec J7H 0E2 Canada;
North America toll-free telephone<PHONE_NUMBER> or direct-dial telephone
450-990-7272; fax<PHONE_NUMBER>; email mhirj.com">[email protected]mhirj.com; internet
mhirj.com.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available at
regulations.gov under Docket No. FAA-2022-0011.

FOR FURTHER INFORMATION CONTACT: Jiwan Karunatilake, Aerospace
Engineer, Airframe and Propulsion Section, FAA, New York ACO Branch,
1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-
7300; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued TCCA AD CF-2021-16, dated April 26,
2021 (TCCA AD CF-2021-16) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for certain MHI RJ Aviation ULC Model CL-600-2B19 (Regional Jet Series
100 & 440) airplanes, Model CL-600-2C10 (Regional Jet Series 700, 701 &
702) airplanes, Model CL-600-2C11 (Regional Jet Series 550) airplanes,
Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-
2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25
(Regional Jet Series 1000) airplanes. You may examine the MCAI in the
AD docket on the internet at regulations.gov by searching for and
locating Docket No. FAA-2022-0011.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain MHI RJ Aviation
ULC Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes, Model
CL-600-2C10 (Regional Jet Series 700, 701 & 702) airplanes, Model CL-
600-2C11 (Regional Jet Series 550) airplanes, Model CL-600-2D15
(Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet
Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000)
airplanes. The NPRM published in the Federal Register on January 25,
2022 (87 FR 3716). The NPRM was prompted by reports of corrosion on
fuel clamshell couplings installed in the fuel tank, and a
determination that new or more restrictive airworthiness limitations
are necessary. The NPRM proposed to require removing and replacing the
fuel clamshell couplings on certain airplanes, and revising the
existing maintenance or inspection program, as applicable, to
incorporate new or more restrictive airworthiness limitations. The FAA
is issuing this AD to address corroded fuel clamshell couplings in the
fuel tank, which, if not removed and replaced, could reduce the ability
of the fuel coupling to conduct lightning current and possibly lead to
arcing and subsequent fuel tank ignition in the event of a lightning
strike. See the MCAI for additional background information.

Discussion of Final Airworthiness Directive

Comments

    The FAA received a comment from the Air Line Pilots Association,
International (ALPA) who supported the NPRM without change.
    The FAA received one additional comment from MHI RJ Aviation. The
following presents the comment received on the NPRM and the FAA's
response.

Request for Clarification for Incorporating Temporary Revisions (TRs)

    MHI RJ Aviation requested that the proposed AD be revised to
include provisional statement allowing the incorporation of TRs in
their respective manuals. MHI RJ Aviation conceded that the provision
that allows this may be included in paragraph (k) of the proposed AD,
but noted that it is not clear. MHI RJ Aviation requested that the FAA
consider adding a provision to avoid requests for alternative methods
of compliance (AMOCs) from operators.

MHI RJ Aviation provided the status of each TR and whether or not the
information in the TR has been incorporated into the MHI RJ Maintenance
Requirements Manual (MRM).
    The FAA agrees to clarify. Paragraphs (h) and (j) of this AD
require operators to ``incorporate the information specified in'' CRJ
Series Regional Jet TR ALI-0740, dated October 13, 2020; CRJ Series
Regional Jet TR ALI-0741, dated October 13, 2020; CRJ700/900/1000
Series Regional Jet TR ALI-0751, dated April 8, 2021; TR 2S4-002, dated
September 1, 2021; and TR 2S4-003, dated September 1, 2021. Therefore,
as long as the information in the applicable MRM is identical to the
information in the applicable TR, the operator may incorporate either
the applicable MRM or the applicable TR to show compliance with this
AD. The FAA has not changed this AD in this regard.

Conclusion

    The FAA reviewed the relevant data, considered the comments
received, and determined that air safety requires adopting this AD as
proposed. Except for minor editorial changes, this AD is adopted as
proposed in the NPRM. None of the changes will increase the economic
burden on any operator. Accordingly, the FAA is issuing this AD to
address the unsafe condition on these products.

Related Service Information Under 1 CFR Part 51

    MHI RJ Aviation has issued Service Bulletin 601R-28-068, Revision
A, dated December 21, 2020; and Service Bulletin 670BA-28-041, Revision
B, dated January 27, 2021. This service information describes
procedures for removing and replacing the fuel clamshell couplings.
These documents are distinct because they apply to different airplane
models.
    MHI RJ Aviation has also issued TR 2S4-002, dated September 1,
2021. This service information describes a Critical Design
Configuration Control Limitation (CDCCL) item for bonding of fuel and
vent lines for lightning protection to preclude a spark.
    MHI RJ Aviation has also issued the following TRs, which describe
airworthiness limitations for fuel tank systems.
     TR 2S4-003, dated September 1, 2021; CRJ Series Regional
Jet TR ALI-0741, dated October 13, 2020; and CRJ700/900/1000 Series
Regional Jet TR ALI-0751, dated April 8, 2021, which describe a
procedure for removing and replacing self-bonding couplings in the fuel
tank.
     CRJ Series Regional Jet TR ALI-0740, dated October 13,
2020, which describes a CDCCL item for bonding of fuel and vent lines
for lightning protection to preclude a spark.
    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.

Costs of Compliance

    The FAA estimates that this AD affects 914 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                     Estimated Costs for Required Actions *
----------------------------------------------------------------------------------------------------------------
            Labor cost                    Parts cost           Cost per product        Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Up to 21 work-hours x $85 per      Up to $5,837...........  Up to $7,622..........  Up to $6,966,508.
 hour = $1,785.
----------------------------------------------------------------------------------------------------------------
* Table does not include estimated costs for revising the maintenance/inspection program.

    The FAA has determined that revising the maintenance or inspection
program takes an average of 90 work-hours per operator, although the
FAA recognizes that this number may vary from operator to operator. In
the past, the FAA has estimated that this action takes 1 work-hour per
airplane. Since operators incorporate maintenance or inspection program
changes for their affected fleet(s), the FAA has determined that a per-
operator estimate is more accurate than a per-airplane estimate.
Therefore, the FAA estimates the total cost per operator to be $7,650
(90 work-hours x $85 per work-hour).
    According to the manufacturer, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected individuals. The FAA does not control warranty coverage for
affected individuals. As a result, the FAA has included all known costs
in the cost estimate.

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 above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

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 adding the following new airworthiness
directive:

2022-18-15 MHI RJ Aviation ULC (Type Certificate Previously Held by
Bombardier, Inc.): Amendment 39-22166; Docket No. FAA-2022-0011;
Project Identifier MCAI-2021-00485-T.

(a) Effective Date

    This airworthiness directive (AD) is effective November 25,
2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the MHI RJ Aviation ULC airplanes,
certificated in any category, identified in paragraphs (c)(1)
through (4) of this AD.
    (1) Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes,
serial numbers 7002 through 7990 inclusive and 8000 through 8112
inclusive.
    (2) Model CL-600-2C10 (Regional Jet Series 700, 701 & 702) and
CL-600-2C11 (Regional Jet Series 550) airplanes, serial numbers
10002 through 10347 inclusive.
    (3) Model CL-600-2D15 (Regional Jet Series 705) and CL-600-2D24
(Regional Jet Series 900) airplanes, serial numbers 15001 through
15499 inclusive.
    (4) Model CL-600-2E25 (Regional Jet Series 1000) airplanes,
serial numbers 19001 through 19064 inclusive.

(d) Subject

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

(e) Reason

    This AD was prompted by reports of corrosion on fuel clamshell
couplings installed in the fuel tank, and a determination that new
or more restrictive airworthiness limitations are necessary. The FAA
is issuing this AD to address corroded fuel clamshell couplings in
the fuel tank, which, if not removed and replaced, could reduce the
ability of the fuel coupling to conduct lightning current and
possibly lead to arcing and subsequent fuel tank ignition in the
event of a lightning strike.

(f) Compliance

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

(g) Clamshell Coupling Replacement: Model CL-600-2B19 Airplanes

    For Model CL-600-2B19 airplanes: Within 6,600 flight hours or 36
months, whichever occurs first after the effective date of this AD,
remove and replace the fuel clamshell couplings, in accordance with
Section 2.B. of the Accomplishment Instructions of MHI RJ Service
Bulletin 601R-28-068, Revision A, dated December 21, 2020.

(h) Revision of the Existing Maintenance or Inspection Program: Model
CL-600-2B19 Airplanes

    For Model CL-600-2B19 airplanes: Within 60 days after the
effective date of this AD, revise the existing maintenance or
inspection program, as applicable, to incorporate the information
specified in paragraphs (h)(1) and (2) of this AD into Supplement
4--FAA Fuel System Limitations of Part 2, Airworthiness
Requirements, of the MHI RJ Maintenance Requirements Manual (MRM).
    (1) Critical Design Configuration Control Limitation (CDCCL)
Item as specified in MHI RJ Temporary Revision (TR) 2S4-002, dated
September 1, 2021.
    (2) Fuel System Limitation Task 28-23-00-605 as specified in MHI
RJ TR 2S4-003, dated September 1, 2021.

(i) Clamshell Coupling Replacement: Model CL-600-2C10, CL-600-2C11, CL-
600-2D15, CL-600-2D24, and CL-600-2E25 Airplanes

    For Model CL-600-2C10 and CL-600-2C11 airplanes; Model CL-600-
2D15 and CL-600-2D24 airplanes, serial numbers 15001 through 15494
inclusive; and Model CL-600-2E25 airplanes: Within 8,800 flight
hours or 48 months, whichever occurs first after the effective date
of this AD, replace the fuel clamshell couplings, in accordance with
Section 2.B. of the Accomplishment Instructions of MHI RJ Service
Bulletin 670BA-28-041, Revision B, dated January 27, 2021.

(j) Revision of the Existing Maintenance or Inspection Program: Model
CL-600-2C10, CL-600-2C11, CL-600-2D15, CL-600-2D24, and CL-600-2E25
Airplanes

    For Model CL-600-2C10, CL-600-2C11, CL-600-2D15, CL-600-2D24,
and CL-600-2E25 airplanes: Within 60 days after the effective date
of this AD, revise the existing maintenance or inspection program,
as applicable, to incorporate the information specified in
paragraphs (j)(1) and (2) of this AD.
    (1) Fuel System Limitation Task 28-21-15-601 as specified in
[MHI RJ] CRJ Series Regional Jet TR ALI-0741, dated October 13,
2020; and Description Applicability for Airworthiness Limitation
Task 28-21-15-601 as amended by [MHI RJ] CRJ700/900/1000 Series
Regional Jet TR ALI-0751, dated April 8, 2021; in Section 4-28 of
Part 2, Airworthiness Requirements, of the MHI RJ MRM.
    (2) CDCCL Item as specified in [MHI RJ] CRJ Series Regional Jet
TR ALI-0740, dated October 13, 2020, in Section 5-00 of Part 2,
Airworthiness Requirements, of the MHI RJ MRM.

(k) No Alternative Actions, Intervals, or CDCCLs

    After the existing maintenance or inspection program has been
revised as required by paragraphs (h) and (j) of this AD, no
alternative actions (e.g., inspections), intervals, or CDCCLs may be
used unless the actions, intervals, and CDCCLs are approved as an
alternative method of compliance (AMOC) in accordance with the
procedures specified in paragraph (m)(1) of this AD.

(l) Credit for Previous Actions

    (1) This paragraph provides credit for actions required by
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD using MHI RJ Service Bulletin 601R-28-068,
dated December 3, 2020.
    (2) This paragraph provides credit for actions required by
paragraph (i) of this AD, if those actions were performed before the
effective date of this AD using MHI RJ Service Bulletin 670BA-28-
041, dated December 3, 2020; or Revision A, dated December 21, 2020.

(m) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or responsible Flight Standards Office, as appropriate. If
sending information directly to the manager of the New York ACO
Branch, mail it to ATTN: Program Manager, Continuing Operational
Safety, at the address identified in paragraph (n)(2) of this AD or
email to: [email protected]. If mailing information, also
submit information by email. Before using any approved AMOC, notify
your appropriate principal inspector, or lacking a principal
inspector, the manager of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or refer to TCCA; or MHI RJ Aviation ULC's TCCA Design
Approval Organization (DAO). If approved by the DAO, the approval
must include the DAO-authorized signature.

(n) Additional Information

    (1) Refer to TCCA CF-2021-16, dated April 26, 2021, for related
information. This TCCA AD may be found in the AD docket at
regulations.gov under Docket No. FAA-2022-0011.
    (2) For more information about this AD, contact Jiwan
Karunatilake, Aerospace Engineer, Airframe and Propulsion Section,
FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury,
NY 11590; telephone<PHONE_NUMBER>; email [email protected].
    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (o)(3) and (4) of this AD.

(o) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) MHI RJ Service Bulletin 601R-28-068, Revision A, dated
December 21, 2020.

    (ii) MHI RJ Service Bulletin 670BA-28-041, Revision B, dated
January 27, 2021.
    (iii) MHI RJ Temporary Revision (TR) 2S4-002, dated September 1,
2021.
    (iv) MHI RJ TR 2S4-003, dated September 1, 2021.
    (v) [MHI RJ] CRJ Series Regional Jet TR ALI-0740, dated October
13, 2020.
    (vi) [MHI RJ] CRJ Series Regional Jet TR ALI-0741, dated October
13, 2020.
    (vii) [MHI RJ] CRJ700/900/1000 Series Regional Jet TR ALI-0751,
dated April 8, 2021.
    (3) For MHI RJ Aviation ULC service information identified in
this AD, contact MHI RJ Aviation Group, Customer Response Center,
3655 Ave. des Grandes-Tourelles, Suite 110, Boisbriand,
Qu[eacute]bec J7H 0E2 Canada; North America toll-free telephone 833-
990-7272 or direct-dial telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>;
email mhirj.com">[email protected]mhirj.com; internet mhirj.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email [email protected], or go to: archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on August 29, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-22333 Filed 10-20-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 75, Number 242 (Friday, December 17, 2010)]
[Notices]
[Page 79070]
[FR Doc No: 2010-31718]

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

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Notice of Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits Filed Under Subpart B
(Formerly Subpart Q) During the Week Ending November 6, 2010

    The following Applications for Certificates of Public Convenience
and Necessity and Foreign Air Carrier Permits were filed under Subpart
B (formerly Subpart Q) of the Department of Transportation's Procedural
Regulations (See 14 CFR 301.201 et seq.). The due date for Answers,
Conforming Applications, or Motions To Modify Scope are set forth below
for each application. Following the Answer period DOT may process the
application by expedited procedures. Such procedures may consist of the
adoption of a show-cause order, a tentative order, or in appropriate
cases a final order without further proceedings.
    Docket Number: DOT-OST-2010-0276.
    Date Filed: November 5, 2010.
    Due Date for Answers, Conforming Applications, or Motion To Modify
Scope: November 26, 2010.
    Description: Application of Volga-Dnepr Airlines LLC requesting a
foreign air carrier permit to engage in charter foreign air
transportation of property and mail between any point or points in the
Russian Federation and any point or points in the United States and
other all cargo charters.

Renee V. Wright,
Program Manager, Docket Operations, Federal Register Liaison.
[FR Doc. 2010-31718 Filed 12-16-10; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Proposed Rules]
[Pages 22383-22385]
[FR Doc No: 2023-07648]

========================================================================
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. 71 / Thursday, April 13, 2023 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-0663; Project Identifier AD-2023-00020-E]
RIN 2120-AA64

Airworthiness Directives; General Electric Company Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain General Electric Company (GE) GEnx-1B and GEnx-2B model
turbofan engines. This proposed AD was prompted by a manufacturer
investigation that revealed that certain stages 6-10 compressor rotor
spools and forward seals were manufactured from powder metal material
suspected to contain iron inclusion. This proposed AD would require the
replacement of the affected stages 6-10 compressor rotor spools and
forward seals. The FAA is proposing this AD to address the unsafe
condition on these products.

DATES: The FAA must receive comments on this proposed AD by May 30,
2023.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov by
searching for and locating Docket No. FAA-2023-0663; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, any comments
received, and other information. The street address for Docket
Operations is listed above.
    Material Incorporated by Reference:
     For GE service information identified in this NPRM,
contact General Electric Company, 1 Neumann Way, Cincinnati, OH 45215;
phone:<PHONE_NUMBER>; email: ge.com">[email protected]ge.com; website:
ge.com.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Alexei Marqueen, Aviation Safety
Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803;
phone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2023-0663; Project Identifier
AD-2023-00020-E'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Alexei Marqueen, Aviation Safety Engineer, ECO Branch, FAA, 1200
District Avenue, Burlington, MA 01803. Any commentary that the FAA
receives which is not specifically designated as CBI will be placed in
the public docket for this rulemaking.

Background

    The FAA was notified by the manufacturer of the detection of iron
inclusion in a high-pressure turbine stage 2 disk manufactured from the
same powder metal material used to manufacture certain stages 6-10
compressor rotor spools and forward seals for GEnx-1B64/P2, GEnx-1B67/
P2, GEnx-1B70/75/P2, GEnx-1B70/P2, GEnx-1B70C/P2, GEnx-1B74/75/P2,
GEnx-1B76/P2, GEnx-1B76A/P2, and GEnx-2B67/P model turbofan engines. A
manufacturer investigation determined that the iron inclusion was
introduced during the manufacturing process from raw material filtering
screens that had degraded, and certain stages 6-10 compressor rotor
spools and forward seals manufactured using the same process may have
reduced material properties and a lower fatigue life capability due to
the iron inclusion. Further investigation by the manufacturer
identified additional degraded filtering screens which had the
potential to increase the population of parts that were subjected to
iron inclusion during manufacturing. As a result of its investigation,
GE published service information that specifies procedures for the
removal and replacement of certain stages 6-10 compressor rotor spools
and forward seals. This condition, if not addressed, could result in
uncontained debris

release, damage to the engine, and damage to the aircraft.

FAA's Determination

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

Related Service Information Under 1 CFR Part 51

    The FAA reviewed GE GEnx-1B Service Bulletin 72-0515 R00, Initial
Issue, dated January 31, 2023. The FAA also reviewed GE GEnx-2B Service
Bulletin 72-0452 R00, Initial Issue, dated January 31, 2023. This
service information specifies procedures for removal and replacement of
the stages 6-10 compressor rotor spool and forward seal. These
documents are distinct since they apply to different engine models.
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 ADDRESSES.

Proposed AD Requirements in This NPRM

    This proposed AD would require removal of the affected stages 6-10
compressor rotor spools and forward seals and replacement with a part
eligible for installation.

Interim Action

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

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 13 engines installed on airplanes of U.S. registry. The FAA
estimates that nine of the 13 engines will require replacing the stages
6-10 compressor rotor spool and four of the 13 engines will require
replacing the forward seal.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Replace stages 6-10 compressor rotor    8 work-hours x $85 per          $841,088        $841,768      $7,575,912
 spool.                                  hour = $680.
Replace forward seal..................  8 work-hours x $85 per           389,976         390,656       1,562,624
                                         hour = $680.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

General Electric Company: Docket No. FAA-2023-0663; Project
Identifier AD-2023-00020-E.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by May 30, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to General Electric Company (GE) GEnx-1B64/P2,
GEnx-1B67/P2, GEnx-1B70/75/P2, GEnx-1B70/P2, GEnx-1B70C/P2, GEnx-
1B74/75/P2, GEnx-1B76/P2, GEnx-1B76A/P2, and GEnx-2B67/P model
turbofan engines with an installed:
    (1) Stages 6-10 compressor rotor spool having a part number (P/
N) and serial number (S/N) listed in paragraph 4, Appendix--A, Table
1 of GE GEnx-1B Service Bulletin 72-0515, Initial Issue, dated
January 31, 2023 (GEnx-1B 72-0515); or
    (2) Forward seal having a P/N and S/N listed in paragraph 4,
Appendix--A, Table 2 of GEnx-1B 72-0515; or
    (3) Stages 6-10 compressor rotor spool having a P/N and S/N
listed in paragraph 4, Appendix--A, Table 1 of GE GEnx-2B Service
Bulletin 72-0452, Initial Issue, dated January 31, 2023. (GEnx-2B
72-0452); or
    (4) Forward seal having a P/N and S/N listed in paragraph 4,
Appendix--A, Table 2 of GEnx-2B 72-0452.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7230, Turbine Engine
Compressor Section; 7250, Turbine Section.

(e) Unsafe Condition

    This AD was prompted by a manufacturer investigation that
revealed certain stages 6-10 compressor rotor spools and forward
seals were subject to iron inclusion introduced during the
manufacturing process. The FAA is issuing this AD to prevent
fracture and potential uncontained failure of certain stages 6-10
compressor rotor spools and forward seals. The unsafe condition, if
not addressed, could result in uncontained debris release, damage to
the engine, and damage to the aircraft.

(f) Compliance

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

(g) Required Actions

    (1) For affected GEnx-1B model turbofan engines, at the next
piece-part exposure after the effective date of this AD, or before
the affected stages 6-10 compressor rotor spool reaches the cyclic
removal threshold listed in paragraph 4., Appendix--A, Table 1 of
GEnx-1B 72-0515, whichever occurs first, remove the affected stages
6-10 compressor rotor spool from service and replace with a part
eligible for installation.
    (2) For affected GEnx-1B model turbofan engines, at the next
piece-part exposure after the effective date of this AD, or before
the affected forward seal exceeds the cyclic removal threshold
listed in paragraph 4., Appendix--A, Table 2 of GEnx-1B 72-0515,
whichever occurs first, remove the affected forward seal from
service and replace with a part eligible for installation.
    (3) For affected GEnx-2B model turbofan engines, at the next
piece-part exposure after the effective date of this AD, or before
the affected stages 6-10 compressor rotor spool exceeds the cyclic
removal threshold listed in paragraph 4., Appendix--A, Table 1 of
GEnx-2B 72-0452, whichever occurs first, remove the affected stages
6-10 compressor rotor spool from service and replace with a part
eligible for installation.
    (4) For affected GEnx-2B model turbofan engines, at the next
piece-part exposure after the effective date of this AD, or before
the affected forward seal exceeds the cyclic removal threshold
listed in paragraph 4., Appendix--A, Table 2 of GEnx-2B 72-0452,
whichever occurs first, remove the affected forward seal from
service and replace with a part eligible for installation.

(h) Definitions

    (1) For the purpose of this AD, a ``part eligible for
installation'' is any stages 6-10 compressor rotor spool or forward
seal with a P/N and S/N not listed in paragraph 4, Appendix--A,
Table 1 or paragraph 4, Appendix--A, Table 2 of GEnx-1B 72-0515 or
GEnx-2B 72-0452.
    (2) For the purpose of this AD, ``piece-part exposure'' is when
the affected part is removed from the engine.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO 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
certification office, send it to the attention of the person
identified in paragraph (j) of this AD and email to: [email protected].
    (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

    For more information about this AD, contact Alexei Marqueen,
Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; email:
[email protected].

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) GE GEnx-1B Service Bulletin 72-0515, Initial Issue, dated
January 31, 2023.
    (ii) GE GEnx-2B Service Bulletin 72-0452, Initial Issue, dated
January 31, 2023.
    (3) For GE service information identified in this AD, contact
General Electric Company, 1 Neumann Way, Cincinnati, OH 45215;
phone:<PHONE_NUMBER>; email: ge.com">[email protected]ge.com; website:
ge.com.
    (4) You may view this service information at FAA, Airworthiness
Products Section, Operational Safety Branch, 1200 District Avenue,
Burlington, MA 01803. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on April 1, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-07648 Filed 4-12-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: April 10, 2008 (Volume 73, Number 70)]
[Notices]
[Page 19509-19510]
[DOCID:fr10ap08-56]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0213] (formerly Docket No. 2007N-0460)

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reports of
Corrections and Removals

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 12,
2008.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All comments
should be identified with the OMB control number 0910-0359. Also
include the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Reports of Corrections and Removals--21 CFR Part 806; (OMB Control
Number 0910-0359)--Extension

    The collection of information required under the reports of
corrections and removals, part 806 (21 CFR part 806), implements
section 519(f) of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360i(f)), as amended by the Food and Drug Modernization Act
of 1997 (FDAMA) (21 U.S.C. 301) (Public Law 105-115). Each device
manufacturer or importer under Sec.  806.10 shall submit a written
report to FDA of any action initiated to correct or remove a device to
reduce a risk to health posed by the device, or to remedy a violation
of the act caused by the device which may present a risk to health,
within 10 working days of initiating such correction or removal. Each
device manufacturer or importer of a device who initiates a correction
or removal of a device that is not required to be reported to FDA under
Sec.  806.20 shall keep a record of such correction or removal.
    The information collected in the reports of corrections and
removals will be used by FDA to identify marketed devices that have
serious problems and to ensure that defective devices are removed from
the market. This will assure that FDA has current and complete
information regarding these corrections and removals and to determine
whether recall action is adequate.
    In the Federal Register of December 11, 2007 (72 FR 70327), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.

                                                     TABLE 1.--ESTIMATED ANNUAL REPORTING BURDEN\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 No. of        Annual Frequency     Total Annual        Hours per
                      21 CFR Section                          Respondents        per Response        Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
806.10                                                                   488                  1                488                 10              4,880
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                4,880
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   TABLE 2.--ESTIMATED ANNUAL RECORDKEEPING BURDEN\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Annual Frequency
                      21 CFR Section                             No. of              per            Total Annual    Hours per  Record     Total Hours
                                                             Recordkeepers      Recordkeeping         Records
--------------------------------------------------------------------------------------------------------------------------------------------------------
806.20                                                                   132                  1                132                 10              1,320
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                1,320
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    In preparing the previous clearances for approval of the
information collection requirements under Sec. Sec.  806.10 and 806.20,
FDA reviewed the reports of corrections and removals submitted for the
previous 3 years under part 7 (21 CFR part 7), the agency's recall
provisions. FDA has determined that estimates of the reporting burden
in Sec.  806.10 should be revised to reflect a 1.2 percent increase for
reports and records submitted under part 7 due to a decrease in class I
and class II recall actions. FDA also estimates the reporting burden in
Sec.  806.20 should be revised to reflect a reduction of 8 percent for
reports and records submitted under part 7 due to a decrease in class
III recall actions. The time needed to collect information has not been
changed.

    Dated: April 4, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-7638 Filed 4-9-08; 8:45 am]

BILLING CODE 4160-01-S