[Federal Register Volume 77, Number 55 (Wednesday, March 21, 2012)]
[Notices]
[Pages 16544-16547]
[FR Doc No: 2012-6583]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-0757; FRL-9326-3]

Pesticide Product Registration Approvals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's issuance, pursuant to the
provisions of section 3(c)(5) of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), of certain registrations for new pesticide
products and amended registrations for currently existing pesticide
products.

FOR FURTHER INFORMATION CONTACT: A contact person, with telephone
number and email address, is listed at the end of each registration and
amended registration approval summary. You may also reach each contact
person by mail at Biopesticides and Pollution Prevention Division
(7511P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

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 code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 contact person listed at the end of the
registration or amended registration approval summary of interest.

B. How can I get copies of this document and other related Information?

    For each registration and amended registration approval summary
(see Unit IV. and Unit V.), EPA has established a unique docket
identification (ID) number. 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>.
    In accordance with section 3(c)(2) of FIFRA, copies of approved
labels, lists of data references, data and other scientific information
used to support registration or amended registration, except for
material specifically protected by section 10 of FIFRA, are also
available for public inspection. Requests for data must be made in
accordance with the provisions of the Freedom of Information Act and
must be addressed to the Freedom of Information Office (A-101), 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001. Such requests should
identify the product name and registration number and specify the data
or information desired.
    Paper copies of the fact sheets, which provide more detail on these
registrations and amended registrations, may be obtained from the
National Technical Information Service (NTIS), 5285 Port Royal Rd.,
Springfield, VA 22161.

II. EPA's Approval Process

    EPA approved the subject applications in accordance with
established procedures. EPA considered the nature of the active
ingredients, patterns of use, application methods and rates, and levels
and extent of potential exposure. EPA has determined that the active
ingredients described in Units IV. and V., when used in accordance with
widespread and commonly recognized practice, will not generally cause
unreasonable adverse effects on the environment.

III. Public Participation Process

    EPA provides an opportunity to comment on certain registration
actions (i.e., new active ingredients, first food uses, first
residential uses, first outdoor uses, and other actions of significant
interest to the public). Each of the applications described in Units
IV. and V. was subjected to a 30-day public comment period (http://www.epa.gov/pesticides/regulating/registration-status.html).

IV. New Active Ingredients

    1. Bacillus thuringiensis Cry1Ac Protein and the Genetic Material
(Vector PV-GMIR9) Necessary for Its Production in MON 87701 (OECD
Unique Identifier: MON 87701-2) Soybean (Bt Cry1Ac). Docket ID Number:
EPA-HQ-OPP-2010-0023.
    a. Description of New Active Ingredient: Monsanto Company submitted
an application to register a pesticide product, MON 87701 (EPA File
Symbol 524-LOU), containing the new active ingredient, Bt Cry1Ac.
    b. Regulatory Conclusions: On September 9. 2010, EPA registered MON
87701 for use as a seed increase plant-incorporated protectant in
soybean (EPA Reg. No. 524-594).
    c. Missing Data and Conditions for Submission: None.
    d. Response to Comments: EPA received no comments in response to
the notice of receipt published on April 14, 2010 (75 FR 19388; FRL-
8808-5). One comment was received during the 30-day public
participation process occurring immediately prior to the final
registration decision. Monsanto Company noted several technical
corrections needed to be made to the proposed decision and risk
assessment document (i.e., Biopesticides Registration Action Document
or ``BRAD'') posted for public participation. Monsanto also requested a
longer expiration date (five vs. two years) for its registration. In
response, EPA updated the BRAD and granted the MON 87701 registration
for three years. The revised BRAD is posted to the docket with this
notice.
    Contact: Mike Mendelsohn,<PHONE_NUMBER><EMAIL_ADDRESS>    2. Bacteriophage of Clavibacter michiganensis subspecies
michiganensis (Bacteriophage of Cmm). Docket ID Number: EPA-HQ-OPP-
2009-0539.
    a. Description of New Active Ingredient: Interregional Research
Project Number 4 of Rutgers University, on behalf of OmniLytics, Inc.,
submitted an application to register a pesticide product, AgriPhage--
CMM (EPA File Symbol 67986-A), containing the new active ingredient,
bacteriophage of Cmm.
    b. Regulatory Conclusions: On September 30, 2011, EPA registered
Agriphage--CMM (EPA Reg. No. 67986-6) for field and greenhouse uses on
tomato.
    c. Missing Data and Conditions for Submission: EPA is requiring
submission of data on Analysis of Samples (OCSPP Test Guideline
885.1400) and Storage Stability (OCSPP Test Guideline 830.6317) within
one year of registration.
    d. Response to Comments: EPA received no comments on this action.
    Contact: Denise Greenway,<PHONE_NUMBER><EMAIL_ADDRESS>    3. Chromobacterium subtsugae strain PRAA4-1\T\. Docket ID Number:
EPA-HQ-OPP-2010-0058.
    a. Description of New Active Ingredient: Marrone Bio Innovations,
Inc. submitted applications to register two pesticide products, MBI-203
TGAI (EPA File Symbol 84059-O) and MBI-203 EP (EPA File Symbol 84059-
RN), containing the new active ingredient, Chromobacterium subtsugae
strain PRAA4-1\T\.
    b. Regulatory Conclusions: On August 26, 2011, EPA registered MBI-
203 TGAI (EPA Reg. No. 84059-9) for manufacturing use, and MBI-203 EP
Bioinsecticide (EPA Reg. No. 84059-10) for use on agricultural and
greenhouse crops, including vegetables, fruit, flowers, bedding plants,
ornamentals, and turf.
    c. Missing Data and Conditions for Submission: For MBI-203 EP
Bioinsecticide (EPA Reg. No. 84059-10), EPA is requiring submission of
data on Analysis of Samples (OCSPP Test Guideline 885.1400), Storage
Stability (OCSPP Test Guideline 830.6317), and Corrosion
Characteristics (OCSPP Test Guideline 830.6320) by September 1, 2012.
    d. Response to Comments: EPA received no comments on this action.
    Contact: Jeannine Kausch,<PHONE_NUMBER><EMAIL_ADDRESS>    4. 3,7-Dimethyl-2,6-Octadienal (Citral). Docket ID Number: EPA-HQ-
OPP-2010-0804.
    a. Description of New Active Ingredient: Bedoukian Research, Inc.
submitted an application to register a pesticide product, Bedoukian
Citral Technical (EPA File Symbol 52991-EA), containing the new active
ingredient, Citral.
    b. Regulatory Conclusions: On August 23, 2011, EPA registered
Bedoukian Citral Technical (EPA Reg. No. 52991-26) for manufacturing
use.
    c. Missing Data and Conditions for Submission: EPA is requiring
submission of data on Storage Stability (OCSPP Test Guideline 830.6317)
and Corrosion Characteristics (OCSPP Test Guideline 830.6320) within 12
months of registration.
    d. Response to Comments: EPA received no comments on this action.
    Contact: Leonard Cole,<PHONE_NUMBER><EMAIL_ADDRESS>    5. (E,Z,Z)-3,8,11-Tetradecatrienyl Acetate. Docket ID Number: EPA-
HQ-OPP-2010-0040.
    a. Description of New Active Ingredient: ISCA Technologies, Inc.
submitted applications to register two pesticide products, ISCA Tuta MP
(EPA File Symbol 80286-RT) and SPLAT TutaTM (EPA File Symbol
80286-RA), containing the new active ingredient, (E,Z,Z)-3,8,11-
Tetradecatrienyl Acetate.
    b. Regulatory Conclusions: On September 1, 2010, EPA registered
ISCA Tuta MP (EPA Reg. No. 80286-17) for manufacturing use, and SPLAT
TutaTM (EPA Reg. No. 80286-16) for use on all crops as a
mating disrupter for South American tomato leafminer (Tuta absoluta).
    c. Missing Data and Conditions for Submission: EPA is requiring
submission of data on Storage Stability (OCSPP Test Guideline 830.6317)
and Corrosion Characteristics (OCSPP Test Guideline 830.6320) for both
products within 1 year of registration.
    d. Response to Comments: EPA received no comments on this action.
    Contact: Menyon Adams,<PHONE_NUMBER><EMAIL_ADDRESS>    6. (E,Z)-2,13-Octadecadien-1-yl and (E,Z)-2,13-Octadecadien-1-ol.
Docket ID Number: EPA-HQ-OPP-2011-0247.
    a. Description of New Active Ingredients: Pacific Biocontrol
Corporation submitted an application to register a pesticide product,
Isomate[supreg] DWB (EPA File Symbol 53575-UN), containing the new
active ingredients, (E,Z)-2,13-Octadecadien-1-yl and (E,Z)-2,13-
Octadecadien-1-ol.
    b. Regulatory Conclusions: On August 23, 2011, EPA registered
Isomate[supreg] DWB (EPA Reg. No. 53575-40) for use on pome fruit,
stone fruit, tree nut, and ornamental nursery crops.
    c. Missing Data and Conditions for Submission: None.
    d. Response to Comments: EPA received no comments on this action.
    Contact: Gina Burnett,<PHONE_NUMBER><EMAIL_ADDRESS>    7. Isopropyl Myristate. Docket ID Number: EPA-HQ-OPP-2010-0082.
    a. Description of New Active Ingredient: Piedmont Animal Health LLC
submitted an application to register a pesticide product,
ResultixTM (EPA

File Symbol 86865-R), containing the new active ingredient, Isopropyl
Myristate.
    b. Regulatory Conclusions: On August 25, 2011, EPA registered
ResultixTM (EPA Reg. No. 86865-1) for treatment of ticks on
cats and dogs.
    c. Missing Data and Conditions for Submission: None.
    d. Response to Comments: EPA received no comments on this action.
    Contact: Cheryl Greene,<PHONE_NUMBER><EMAIL_ADDRESS>    8. Oregano Oil. Docket ID Number: EPA-HQ-OPP-2008-0019.
    a. Description of New Active Ingredient: Moss Buster LLC submitted
an application to register a pesticide product, Moss Buster[supreg]
(EPA File Symbol 84316-R), containing the new active ingredient,
Oregano Oil.
    b. Regulatory Conclusions: On March 14, 2011, EPA registered Moss
Buster[supreg] (EPA Reg. No. 84316-1) to control moss on surfaces
(e.g., patios, walls, and rooftops).
    c. Missing Data and Conditions for Submission: EPA is requiring
submission of data on Storage Stability (OCSPP Test Guideline 830.6317)
and Corrosion Characteristics (OCSPP Test Guideline 830.6320) within 1
year of registration.
    d. Response to Comments: EPA received no comments on this action.
    Contact: Leonard Cole,<PHONE_NUMBER><EMAIL_ADDRESS>    9. Paecilomyces fumosoroseus strain FE 9901. Docket ID Number: EPA-
HQ-OPP-2010-0093.
    a. Description of New Active Ingredient: Technology Sciences Group,
Inc., on behalf of Natural Industries, Inc., submitted applications to
register two pesticide products, NoFlyTM WP (EPA File Symbol
73314-A) and NoFlyTM Technical (EPA File Symbol 73314-T),
containing the new active ingredient, Paecilomyces fumosoroseus strain
FE 9901.
    b. Regulatory Conclusions: On May 12, 2011, EPA registered
NoFlyTM Technical (EPA Reg. No. 73314-7) for manufacturing
use, and NoFlyTM WP (EPA Reg. No. 73314-6) for use on
nonfood greenhouse and nursery crops to control whiteflies, aphids,
thrips, psyllids, mealybugs, leafhoppers, plant bugs, weevils,
grasshoppers, Mormon crickets, locusts, and beetles.
    c. Missing Data and Conditions for Submission: EPA is requiring
submission of the following data:
    i. Analysis of Samples (OCSPP Test Guideline 885.1400), Storage
Stability (OCSPP Test Guideline 830.6317), and Corrosion
Characteristics (OCSPP Test Guideline 830.6320) for both products
within 18 months of registration;
    ii. Stability to Normal and Elevated Temperatures, Metals and Metal
Ions (OCSPP Test Guideline 830.6313) for NoFlyTM WP within
12 months of registration; and
    iii. Additional confirmatory data on the Acute Injection Toxicity/
Pathogenicity (Intraperitoneal) study (OCSPP Test Guideline 885.3200)
for NoFlyTM Technical within 6 months of registration.
    d. Response to Comments: EPA received no comments on this action.
    Contact: Kathleen Martin,<PHONE_NUMBER><EMAIL_ADDRESS>    10. Penta-Termanone. Docket ID Number: EPA-HQ-OPP-2009-0333.
    a. Description of New Active Ingredient: Bayer Environmental
Science submitted an application to register a pesticide product,
Penta-TermanoneTM Technical (EPA File Symbol 432-RLNU),
containing the new active ingredient, Penta-Termanone.
    b. Regulatory Conclusions: On July 15, 2011, EPA registered Penta-
TermanoneTM Technical (EPA Reg. No. 432-1504) for
manufacturing use.
    c. Missing Data and Conditions for Submission: EPA is requiring
submission of data on Storage Stability (OCSPP Test Guideline 830.6317)
and Corrosion Characteristics (OCSPP Test Guideline 830.6320) within 1
year of registration.
    d. Response to Comments: EPA received no comments on this action.
    Contact: Menyon Adams,<PHONE_NUMBER><EMAIL_ADDRESS>    11. Pseudomonas fluorescens strain CL145A. Docket ID Number: EPA-
HQ-OPP-2011-0568.
    a. Description of New Active Ingredient: Marrone Bio Innovations,
Inc. submitted applications to register two pesticide products, MOI-401
TGAI (EPA File Symbol 84059-U) and MOI-401 EP (EPA File Symbol 84059-
L), containing the new active ingredient, Pseudomonas fluorescens
strain CL145A.
    b. Regulatory Conclusions: On July 29, 2011, EPA registered MOI-401
TGAI (EPA Reg. No. 84059-4) for manufacturing use, and MOI-401 EP (EPA
Reg. No. 84059-5) for use in enclosed static or flowing water
infrastructures infested with zebra and/or quagga mussels.
    c. Missing Data and Conditions for Submission: EPA is requiring
submission of data on Storage Stability (OCSPP Test Guideline 830.6317)
for MOI-401 TGAI (EPA Reg. No. 84059-4), and Storage Stability (OCSPP
Test Guideline 830.6317) and Corrosion Characteristics (OCSPP Test
Guideline 830.6320) for MOI-401 (EPA Reg. No. 84059-5) by January 29,
2012.
    d. Response to Comments: EPA received no comments on this action.
    Contact: Ann Sibold,<PHONE_NUMBER><EMAIL_ADDRESS>    12. Trichoderma asperellum strain T34. Docket ID Number: EPA-HQ-
OPP-2010-0247.
    a. Description of New Active Ingredient: Wagner Regulatory
Associates, Inc., on behalf of Biocontrol Technologies, S.L., submitted
an application to register a pesticide product, T34 Biocontrol (EPA
File Symbol 87301-R), containing the new active ingredient, Trichoderma
asperellum strain T34.
    b. Regulatory Conclusions: On October 20, 2011, EPA registered T34
Biocontrol (EPA Reg. No. 87301-1) for nonfood, greenhouse use.
    c. Missing Data and Conditions for Submission: EPA is requiring
submission of data on Acute Injection Toxicity/Pathogenicity (OCSPP
Test Guideline 885.3200) by October 20, 2012.
    d. Response to Comments: EPA received no comments on this action.
    Contact: Michael Glikes,<PHONE_NUMBER><EMAIL_ADDRESS>    13. Typhula phacorrhiza strain 94671. Docket ID Number: EPA-HQ-OPP-
2010-0090.
    a. Description of New Active Ingredient: Technology Sciences Group,
Inc., on behalf of Agrium Advanced Technologies RP, Inc., submitted
applications to register two pesticide products, Nivalis (EPA File
Symbol 84888-E) and Nivalis Technical (EPA File Symbol 84888-R),
containing the new active ingredient, Typhula phacorrhiza strain 94671.
    b. Regulatory Conclusions: On November 2, 2010, EPA registered
Nivalis Technical (EPA Reg. No. 84888-1) for manufacturing use, and
Nivalis (EPA Reg. No. 84888-2) for use to control grey snow mold and
pink snow mold on golf course turf where continuous snow cover persists
for 90 days or longer.
    c. Missing Data and Conditions for Submission: EPA is requiring
submission of data on Storage Stability (OCSPP Test Guideline 830.6317)
and Corrosion Characteristics (OCSPP Test Guideline 830.6320) for both
products within one year of registration.
    d. Response to Comments: EPA received no comments on this action.
    Contact: Denise Greenway,<PHONE_NUMBER><EMAIL_ADDRESS>
V. New Uses for Registered Active Ingredients

    1. Cydia pomonella granulovirus (CpGV). Docket ID Number: EPA-HQ-
OPP-2010-0059.

    a. Description of New Use: Certis USA LLC submitted an application
to amend the pesticide product, CYD-X[supreg] (EPA Reg. No. 70051-44),
containing the active ingredient, CpGV, to allow for new use on apple,
pear, plum, prune, and walnut in residential settings.
    b. Regulatory Conclusions: EPA approved the requested registration
amendment on April 6, 2010 (CYD-X[supreg], EPA Reg. No. 70051-44).
    c. Missing Data and Conditions for Submission: None.
    d. Response to Comments: EPA received no comments on this action.
    Contact: Jeannine Kausch,<PHONE_NUMBER><EMAIL_ADDRESS>    2. Isaria fumosorosea (formerly Paecilomyces fumosoroseus) Apopka
strain 97. Docket ID Number: EPA-HQ-OPP-2010-0088.
    a. Description of New Use: Certis USA LLC submitted applications to
amend two pesticide products, PFR-97TM MUP (EPA Reg. No.
70051-17) and PFR-97TM 20% WDG (EPA Reg. No. 70051-19),
containing the active ingredient, Isaria fumosorosea Apopka strain 97,
to allow for new use on all food commodities. These submissions
required the concurrent establishment of an exemption from the
requirement of a tolerance for residues of Isaria fumosorosea Apopka
strain 97.
    b. Regulatory Conclusions: EPA approved the requested registration
amendments on September 20, 2011 (PFR-97TM MUP, EPA Reg. No.
70051-17; PFR-97TM 20% WDG, EPA Reg. No. 70051-19).
    c. Missing Data and Conditions for Submission: None.
    d. Response to Comments: EPA received no comments on this action.
    Contact: Shanaz Bacchus,<PHONE_NUMBER><EMAIL_ADDRESS>    3. Metarhizium anisopliae strain F52. Docket ID Number: EPA-HQ-OPP-
2010-0081.
    a. Description of New Use: Novozymes Biologicals, Inc. submitted
applications to amend three pesticide products: TAE-001 Technical
Bioinsecticide (EPA Reg. No. 70127-7), Taenure Granular Bioinsecticide
(EPA Reg. No. 70127-8), and TICK-EX EC Bioinsecticide (EPA Reg. No.
70127-10), containing the active ingredient, Metarhizium anisopliae
strain F52, for new use on all food commodities. These submissions
required the concurrent establishment of an exemption from the
requirement of a tolerance for residues of Metarhizium anisopliae
strain F52.
    b. Regulatory Conclusions: EPA approved the requested registration
amendments on April 28, 2011 (TAE-001Technical Bioinsecticide, EPA Reg.
No. 70127-7; Taenure Granular Bioinsecticide, EPA Reg. No. 70127-8;
TICK-EX EC Bioinsecticide, EPA Reg. No. 70127-10).
    c. Missing Data and Conditions for Submission: None.
    d. Response to Comments: EPA received no comments on this action.
    Contact: Shanaz Bacchus,<PHONE_NUMBER><EMAIL_ADDRESS>    4. Sodium Ferric Ethylenediaminetetraacetate (Sodium Ferric EDTA).
Docket ID Number: EPA-HQ-OPP-2010-0182.
    a. Description of New Use: Walter G. Talarek, P.C., on behalf of W.
Neudorff GmbH KG, submitted applications to register three pesticide
products: Ferroxx MP (EPA File Symbol 67702-GR), Slug Exx (EPA File
Symbol 67702-GE), and Ferroxx (EPA File Symbol 67702-GG), containing
the active ingredient, Sodium Ferric EDTA, to allow for new use on all
food commodities. These submissions required the concurrent
establishment of an exemption from the requirement of a tolerance for
residues of Sodium Ferric EDTA.
    b. Regulatory Conclusions: On March 29, 2011, EPA registered
Ferroxx MP (EPA Reg. No. 67702-31) for manufacturing use, and Slug Exx
(EPA Reg. No. 67702-32) and Ferroxx (EPA Reg. No. 67702-33) for use on
all food commodities to control slugs and snails.
    c. Missing Data and Conditions for Submission: None.
    d. Response to Comments: EPA received no comments on this action.
    Contact: Andrew Bryceland,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Chemicals, Pests and pesticides.

    Dated: March 8, 2012.
W. Michael McDavit,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
[FR Doc. 2012-6583 Filed 3-20-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: May 7, 2008 (Volume 73, Number 89)]
[Proposed Rules]
[Page 25609-25612]
[DOCID:fr07my08-29]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0182; Directorate Identifier 2007-NM-262-AD]
RIN 2120-AA64

Airworthiness Directives; Empresa Brasileira de Aeronautica S.A.
(EMBRAER) Model EMB-135ER, -135KE, -135KL, and -135LR Airplanes, and
Model EMB-145, -145ER, -145MR, -145LR, -145XR, -145MP, and -145EP
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of
comment period.

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SUMMARY: We are revising an earlier NPRM for the products listed above.
This action revises the earlier NPRM by expanding the scope. This
proposed AD results from mandatory continuing airworthiness information
(MCAI) originated by an aviation authority of another country to
identify and correct an unsafe condition on an aviation product. The
MCAI describes the unsafe condition as:

    Fuel system reassessment, performed according to RBHA-E88/SFAR-
88 (Regulamento Brasileiro de Homologacao Aeronautica 88/Special
Federal Aviation Regulation No. 88), requires the inclusion of new
maintenance tasks in the Critical Design Configuration Control
Limitations (CDCCL) and in the Fuel System Limitations (FSL),
necessary to preclude ignition sources in the fuel system. * * *

    The proposed AD would require actions that are intended to address
the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by May 27, 2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1405; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-0182;
Directorate Identifier 2007-NM-262-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We proposed to amend 14 CFR part 39 with an earlier NPRM for the
specified products, which was published in the Federal Register on
February 21, 2008 (73 FR 9497). That earlier NPRM proposed to require
actions intended to address the unsafe condition for the products
listed above.
    Since that earlier NPRM was issued, we have determined that for
certain airplanes the initial compliance times for doing the tasks
specified in paragraph (f)(2) of the earlier NPRM

must be reduced. That earlier NPRM resulted from Brazilian
Airworthiness Directive 2007-08-02, effective September 27, 2007
(referred to after this as ``the MCAI'').
    The MCAI does not provide an initial compliance time for doing the
tasks. In the original NPRM, we proposed an initial compliance time
that started from the effective date of the AD; or the date of issuance
of the original Brazilian standard airworthiness certificate or the
date of issuance of the original Brazilian export certificate of
airworthiness; whichever occurs later. Although unstated in the MCAI,
we have determined that the intent of the MCAI is for the initial
compliance time to start from the initial delivery date of the airplane
in order to address the identified unsafe condition in a timely manner.
We have also revised the initial compliance times for clarity by
providing a threshold and grace period for each task. We have revised
this supplemental NPRM by adding Table 1 to specify the initial
compliance times for each task. You may obtain further information by
examining the MCAI in the AD docket.

Comments

    We have considered the following comments received on the earlier
NPRM.

Request To Clarify Compliance Times

    EMBRAER and ExpressJet request that we revise the NPRM to include
paragraph (section) A2.5.1 of Appendix 2 of EMBRAER EMB-135/ERJ-140/
EMB-145 Maintenance Review Board Report (MRBR) MRB-145/1150, Revision
10, dated August 4, 2006. The commenters assert that paragraph A2.5.1
contains provisions to allow operators to implement the required fuel
system limitation inspections in a timely manner. ExpressJet asserts
that without the inclusion of paragraph A2.5.1, operators will be non-
compliant with the AD immediately upon the inclusion of paragraph
A.2.5.2 into the maintenance programs. Finally, ExpressJet asserts that
operators will not have sufficient spare parts and states that they
have been informed that the manufacturer of replacement parts required
by these new limitations will be unable to meet the demand, which could
lead to immediate grounding of airplanes. The commenters therefore
request that we revise the NPRM to include paragraph A2.5.1 of the MRBR
so operators are able to comply with the AD in an achievable time
frame.
    We do not agree with this request to include MRBR paragraph A2.5.1,
which describes deferring the first mandatory inspections to the next
``C'' check (5,000 flight hours). However, as described previously, we
have revised the initial compliance times specified in paragraph (f)(2)
of the supplemental NPRM. With these revised compliance times, there
should be sufficient spare parts. In addition, if an operator decides
that more compliance time is needed, the operator may request an
alternative method of compliance (AMOC) in accordance with paragraph
(g)(1) of the supplemental NPRM.

New Service Information

    Since the NPRM was issued, we have reviewed sections A2.5.2, Fuel
System Limitation Items, and A2.4, Critical Design Configuration
Control Limitation (CDCCL), of Appendix 2 of the EMBRAER EMB-135/ERJ-
140/EMB-145 MRBR MRB-145/1150, Revision 11, dated September 19, 2007
(we referred to the EMBRAER EMB-135/ERJ-140/EMB-145 MRBR MRB-145/1150,
Revision 10, dated August 4, 2006, as the appropriate source of service
information for doing the actions specified in the NPRM). No changes
were made to the tasks specified in the MRBR. We have revised this AD
to refer to Revision 11 of the MRBR.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.
    Certain changes described above expand the scope of the earlier
NPRM. As a result, we have determined that it is necessary to reopen
the comment period to provide additional opportunity for the public to
comment on this proposed AD.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 704 products of U.S. registry. We also estimate that
it would take about 1 work-hour per product to comply with the basic
requirements of this proposed AD. The average labor rate is $80 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $56,320, or $80 per product.

Authority for This Rulemaking

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

Regulatory Findings

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

under the criteria of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Empresa Brasileira De Aeronautica S.A. (Embraer): Docket No. FAA-
2008-0182; Directorate Identifier 2007-NM-262-AD.

Comments Due Date

    (a) We must receive comments by May 27, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to EMBRAER Model EMB-135ER, -135KE, -135KL,
and -135LR airplanes, and Model EMB-145, -145ER, -145MR, -145LR, -
145XR, -145MP, and -145EP airplanes; certificated in any category;
except for Model EMB-145LR airplanes modified according to Brazilian
Supplemental Type Certificate 2002S06-09, 2002S06-10, or 2003S08-01.

    Note 1: This AD requires revisions to certain operator
maintenance documents to include new inspections. Compliance with
these inspections is required by 14 CFR 91.403(c). For airplanes
that have been previously modified, altered, or repaired in the
areas addressed by these inspections, the operator may not be able
to accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (g) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued operational safety of the airplane.

Subject

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

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    Fuel system reassessment, performed according to RBHA-E88/SFAR-
88, requires the inclusion of new maintenance tasks in the Critical
Design Configuration Control Limitations (CDCCL) and in the Fuel
System Limitations (FSL), necessary to preclude ignition sources in
the fuel system. * * *
    The corrective action is revising the Airworthiness Limitations
Section (ALS) of the Instructions for Continued Airworthiness (ICA)
to incorporate new limitations for fuel tank systems.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) The term ``MRBR,'' as used in this AD, means the EMBRAER
EMB-135/ERJ-140/EMB-145 Maintenance Review Board Report (MRBR) MRB-
145/1150, Revision 11, dated September 19, 2007.
    (2) Before December 16, 2008, revise the ALS of the ICA to
incorporate Section A2.5.2, Fuel System Limitation Items, of
Appendix 2 of the MRBR. For all tasks identified in section A2.5.2
of Appendix 2 of the MRBR, the initial compliance times start from
the applicable times specified in Table 1 of this AD; and the
repetitive inspections must be accomplished thereafter at the
interval specified in Section A2.5.2 of Appendix 2 of the MRBR,
except as provided by paragraphs (f)(4) and (g) of this AD.

                                          Table 1.--Initial Inspections
----------------------------------------------------------------------------------------------------------------
                                                                    Compliance time (whichever occurs later)
            Reference No.                    Description       -------------------------------------------------
                                                                       Threshold               Grace period
----------------------------------------------------------------------------------------------------------------
28-11-00-720-001-A00.................  Functionally Check       Before the accumulation  Within 90 days after
                                        critical bonding         of 30,000 total flight   the effective date of
                                        integrity of selected    hours.                   this AD.
                                        conduits inside the
                                        wing tank, Fuel Pump
                                        and FQIS connectors at
                                        tank wall by
                                        conductivity
                                        measurements.
28-17-01-720-001-A00.................  Functionally Check       Before the accumulation  Within 90 days after
                                        critical bonding         of 30,000 total flight   the effective date of
                                        integrity of Fuel        hours.                   this AD.
                                        Pump, VFQIS and Low
                                        Level SW connectors at
                                        tank wall by
                                        conductivity
                                        measurements.
28-21-01-220-001-A00.................  Inspect Electric Fuel    Before the accumulation  Within 90 days after
                                        Pump Connector.          of 10,000 total flight   the effective date of
                                                                 hours.                   this AD.
28-23-03-220-001-A00.................  Inspect Pilot Valve      Before the accumulation  Within 90 days after
                                        harness inside the       of 20,000 total flight   the effective date of
                                        conduit.                 hours.                   this AD.
28-23-04-220-001-A00.................  Inspect Vent Valve       Before the accumulation  Within 90 days after
                                        harness inside the       of 20,000 total flight   the effective date of
                                        conduit.                 hours.                   this AD.
28-27-01-220-001-A00.................  Inspect Electric Fuel    Before the accumulation  Within 90 days after
                                        Transfer Pump            of 10,000 total flight   the effective date of
                                        Connector.               hours.                   this AD.
28-41-01-720-001-A00.................  Functionally Check Fuel  Before the accumulation  Within 90 days after
                                        Conditioning Unit        of 10,000 total flight   the effective date of
                                        (FCU).                   hours.                   this AD.
28-41-03-220-001-A00.................  Inspect FQIS harness     Before the accumulation  Within 90 days after
                                        for clamp and wire       of 20,000 total flight   the effective date of
                                        jacket integrity.        hours.                   this AD.
28-41-04-720-001-A00.................  Functionally Check       Before the accumulation  Within 90 days after
                                        Ventral Fuel             of 10,000 total flight   the effective date of
                                        Conditioning Unit        hours.                   this AD.
                                        (VFCU).

28-41-07-220-001-A00.................  Inspect VFQIS and Low    Before the accumulation  Within 90 days after
                                        Level SW Harness for     of 20,000 total flight   the effective date of
                                        clamp and wire jacket    hours.                   this AD.
                                        integrity.
----------------------------------------------------------------------------------------------------------------

    (3) Before December 16, 2008, or within 90 days after the
effective date of this AD, whichever occurs first, revise the ALS of
the ICA to incorporate items 1, 2, and 3 of section A2.4, Critical
Design Configuration Control Limitation (CDCCL), of Appendix 2 of
the MRBR.
    (4) After accomplishing the actions specified in paragraphs
(f)(2) and (f)(3) of this AD, no alternative inspections, inspection
intervals, or CDCCLs may be used unless the inspections, intervals,
or CDCCLs are part of a later revision of Appendix 2 of the MRBR
that is approved by the Manager, ANM-116, FAA, or ANAC (or its
delegated agent); or unless the inspections, intervals, or CDCCLs
are approved as an alternative method of compliance (AMOC) in
accordance with the procedures specified in paragraph (g) of this
AD.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows: The MCAI specifies a compliance date of ``Before
December 31, 2008'' for doing the ALI revisions. We have already
issued regulations that require operators to revise their
maintenance/inspection programs to address fuel tank safety issues.
The compliance date for these regulations is December 16, 2008. To
provide for coordinated implementation of these regulations and this
AD, we are using this same compliance date in this AD.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to ATTN: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 227-1405; fax<PHONE_NUMBER>. Before using any approved AMOC
on any airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to Brazilian Airworthiness Directive 2007-08-02,
effective September 27, 2007; and sections A2.5.2, Fuel System
Limitation Items, and A2.4, Critical Design Configuration Control
Limitation (CDCCL), of Appendix 2 of the MRBR; for related
information.

    Issued in Renton, Washington, on April 30, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-10065 Filed 5-6-08; 8:45 am]

BILLING CODE 4910-13-P


                                  MEMORANDUM

TO:		William Herz, NLA

FROM:	Jonathan De'Ath, NLA

SUBJECT:	Lime Risk and Technology Review EPA Emissions Database Review Findings

DATE:	April 19, 2018
____________________________________________________________________________

Tab A.5 Kiln_HCl_Data
 HCl test results for Graymont Pleasant Gap kiln 8 should be excluded from calculation of the New Kiln default HCl (lb/hour) (row 41, column P). The new Pleasant Gap Kiln 8 is a gas-fired vertical kiln and not representative of straight rotary, or preheater rotary kilns burning solids fuel.

Tab A.7 Kiln_Dioxin_Furan_Data
 The Lhoist Montevallo dioxin/furan data is excluded from the default calculation because of combined stacks. However, based on test report, the testing location is before the exhaust streams combine, so the data are OK to use.
 Kiln 1 at Martin Marietta uses an ESP (not a fabric-filter baghouse) so may not be representative depending on the operating temperature.

General Comments
 There looks to be an error calculating emission for certain HAPS (e.g., o-HAPs and dioxin/furans) for lime plants with 2 or more kilns that vent to a single stack. Please verify that for kilns with combined stacks, and without actual lbs/hour emissions data, that the calculated emissions on tab A.9 reflect the actual number of kilns, i.e., HAP default lbs/hour emissions data multiplied by the number of kilns. Conversely, if a kiln vents to two stacks (for example Lhoist Montevallo), default emission rates should be halved.


Comment Info: =================

General Comment:Dear Mr. Zeller:

I’m writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491.  On behalf of myself, I respectfully request that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

I’m a consumer of products (e-cigarettes) that are proposed for regulation under the Proposed Rule, which raises a number of significant issues and questions that are important and relevant to me.  The Proposed Rule asks nearly a hundred different questions I might want to respond to.  I would like to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time.  I know that the FDA took many years to even come up with the Proposed Rule, so I do not believe it is unreasonable to allow the public a mere six months to comment on it.  This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. As a 2-pack/day heavy smoker for over 40 years, I was finally able to quit after switching to e-cigarettes in February, 2009.  Quite simply, I firmly believe that they saved my life.  I would like to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account.  I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past.  I am asking that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.

Sincerely,


[Federal Register Volume 86, Number 238 (Wednesday, December 15, 2021)]
[Rules and Regulations]
[Pages 71144-71145]
[FR Doc No: 2021-27135]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2021-N-0590]

Medical Devices; Gastroenterology-Urology Devices; Classification
of the Endoscopic Transhepatic Venous Access Needle

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the endoscopic transhepatic venous access needle into class II (special
controls). The special controls that apply to the device type are
identified in this order and will be part of the codified language for
the endoscopic transhepatic venous access needle's classification. We
are taking this action because we have determined that classifying the
device into class II (special controls) will provide a reasonable
assurance of safety and effectiveness of the device. We believe this
action will also enhance patients' access to beneficial innovative
devices.

DATES: This order is effective December 15, 2021. The classification
was applicable on November 20, 2019.

FOR FURTHER INFORMATION CONTACT: Thelma Valdes, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2610, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the endoscopic transhepatic venous
access needle as class II (special controls), which we have determined
will provide a reasonable assurance of safety and effectiveness. In
addition, we believe this action will enhance patients' access to
beneficial innovation.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation. When FDA classifies a device into
class I or II via the De Novo process, the device can serve as a
predicate for future devices of that type, including for 510(k)'s (see
21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not
have to submit a De Novo request or premarket approval application in
order to market a substantially equivalent device (see 21 U.S.C.
360c(i), defining ``substantial equivalence''). Instead, sponsors can
use the less-burdensome 510(k) process, when necessary, to market their
device.

II. De Novo Classification

    On November 19, 2018, Cook Ireland Ltd. submitted a request for De
Novo classification of the EchoTip[supreg] InsightTM
Portosystemic Pressure Gradient Measuring System. FDA reviewed the
request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on November 20, 2019, FDA issued an order to the
requester classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 876.1050. \1\ We have
named the generic type of device Endoscopic transhepatic venous access
needle, and it is identified as a device that is inserted through the
liver into the

patient's portal/hepatic venous system under endoscopic ultrasound
guidance. It is connected to a separate device intended to measure a
physiological parameter.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

     Table 1--Endoscopic Transhepatic Venous Access Needle Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility testing.
                                         Pyrogenicity testing.
Infection..............................  Sterilization validation.
                                         Pyrogenicity testing.
                                         Shelf life testing.
                                         Package integrity testing.
Use error leading to:
     Access site hemorrhage/
     thrombosis.
     Portal vein penetration     Labeling.
     leading to intrahepatic bleeding.
Improper patient management due to       Non-clinical performance
 inaccurate measurement.                  testing.
                                         Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k).
    At the time of classification, Endoscopic transhepatic venous
access needles are for prescription use only. Prescription devices are
exempt from the requirement for adequate directions for use for the
layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1))
and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulation, have been approved under OMB
control number 0910-0073; and the collection of information in 21 CFR
part 801, regarding labeling have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 876

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 876 is amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1.The authority citation for part 876 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  876.1050 to subpart B to read as follows:

Sec.  876.1050  Endoscopic transhepatic venous access needle.

    (a) Identification. An endoscopic transhepatic venous access needle
is inserted through the liver into the patient's portal/hepatic venous
system under endoscopic ultrasound guidance. It is connected to a
separate device intended to measure a physiological parameter.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (2) Performance data must demonstrate the sterility of the patient-
contacting components of the device.
    (3) The patient-contacting components of the device must be
demonstrated to be non-pyrogenic.
    (4) Performance testing must support the shelf life of device
components provided sterile by demonstrating continued sterility and
package integrity over the labeled shelf life.
    (5) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following must be tested:
    (i) Needle crumple testing;
    (ii) Tensile testing;
    (iii) Dimensional verification for all components; and
    (iv) Simulated use testing.
    (6) Labeling must include the following:
    (i) Instructions for use, including specific instructions regarding
device preparation;
    (ii) The recommended training for safe use of the device; and
    (iii) A shelf life for any sterile components.

    Dated: December 10, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27135 Filed 12-14-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 44 (Tuesday, March 6, 2018)]
[Proposed Rules]
[Pages 9471-9473]
[FR Doc No: 2018-04522]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0006; FRL-9973-27]

Receipt of Several Pesticide Petitions Filed for Residues of
Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of filing of petitions and request for comment.

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SUMMARY: This document announces the Agency's receipt of several
initial filings of pesticide petitions requesting the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before April 5, 2018.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest as shown
in the body of this document, 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 Confidential Business
Information (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.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), main telephone number: (703)
305-7090, email address: [email protected]; or Michael Goodis,
Registration Division (7505P), main telephone number:<PHONE_NUMBER>,
email address: [email protected]. The mailing address for each
contact person is: Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001. As part of the mailing address, include the contact person's
name, division, and mail code. The division to contact is listed at the
end of each pesticide petition summary.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
    [emsp14]Crop production (NAICS code 111).
    [emsp14]Animal production (NAICS code 112).
    [emsp14]Food manufacturing (NAICS code 311).
    [emsp14]Pesticide manufacturing (NAICS code 32532).
    If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT for the division listed at the end of the
pesticide petition summary of interest.

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What action is the Agency taking?

    EPA is announcing its receipt of several pesticide petitions filed
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, requesting the establishment or modification of
regulations in 40 CFR part 180 for residues of pesticide chemicals in
or on various food commodities. The Agency is taking public comment on
the requests before responding to the petitioners. EPA is not proposing
any particular action at this time. EPA has determined that the
pesticide petitions described in this document contain the data or
information prescribed in FFDCA section 408(d)(2), 21 U.S.C.
346a(d)(2); however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data support granting of the
pesticide petitions. After considering the public comments, EPA intends
to evaluate whether and what action may be warranted. Additional data
may be needed before EPA can make a final determination on these
pesticide petitions.
    Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
that are the subject of this document, prepared by the petitioner, is
included in a docket EPA has created for each rulemaking. The docket
for each of the petitions is available at http://www.regulations.gov.
    As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA
is publishing notice of the petitions so that the public has an
opportunity to comment on these requests for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petitions may be obtained
through the petition summaries referenced in this unit.

III. Amended Tolerances

    1. PP 7F8583. (EPA-HQ-OPP-2017-0448). Bayer Crop Science Division,
2 TW Alexander Drive, Durham, NC 27709, requests to amend the tolerance
in 40 CFR 180.645 for residues of the herbicide thiencarbazone-methyl
in or on wheat, forage at 0.15 parts per million (ppm). The high
pressure liquid chromatography/triple stage quadrupole

mass spectrometry (LC/MS/MS) is used to measure and evaluate the
chemical thiencarbazone-methyl. Contact: RD.
    2. PP 7F8590. (EPA-HQ-OPP-2017-0744). Syngenta Crop Protection,
LLC, P.O. Box 18300, Greensboro, NC 27419, requests to establish the
tolerance in 40 CFR 180.507 for residues of the fungicide,
azoxystrobin, in or on Beet, sugar, roots at 5.0 ppm and Vegetable,
root, subgroup 1B at 0.5 ppm. The gas chromatography with nitrogen-
phosphorus detection (GC-NPD) or in mobile phase by high performance
liquid chromatography with ultra-violet detection (HPLC-UV) is used to
measure and evaluate the chemical azoxystrobin. Contact: RD.
    3. PP 7F8590. (EPA-HQ-OPP-2017-0744). Syngenta Crop Protection,
LLC, P.O. Box 18300, Greensboro, NC 27419, requests to amend the
tolerances in 40 CFR 180.507 for residues of the fungicide,
azoxystrobin by removing the tolerance on Vegetable, root, subgroup 1A
at 0.5 ppm. The GC-NPD or in mobile phase by HPLC-UV detection is used
to measure and evaluate the chemical azoxystrobin. Contact: RD.

IV. New Tolerance Exemptions for Non-Inerts (Except PIPS)

    1. PP 6F8535. (EPA-HQ-OPP-2017-0315). Technology Sciences Group
Inc., 712 Fifth St., Suite A, Davis, CA 95616 (on behalf of Lesaffre
Yeast Corporation, 7475 W. Main St., Milwaukee, WI 53214), requests to
establish an exemption from the requirement of a tolerance in 40 CFR
part 180 for residues of the systemic resistance inducer (SRI)
Cerevisane (cell walls of Saccharomyces cerevisiae strain LAS117) in or
on all food commodities. The petitioner believes no analytical method
is needed because it is expected that, when used as proposed,
Cerevisane (cell walls of Saccharomyces cerevisiae strain LAS117) would
not result in residues that are of toxicological concern. Contact:
BPPD.
    2. PP 7F8562. (EPA-HQ-OPP-2017-0593). Otsuka Pharmaceutical Co.,
Ltd., 2-9 Kanda-Tsukasamachi, Chiyoda-ku, Tokyo, 101-8535, Japan (c/o
Technology Sciences Group Inc., 712 Fifth St., Suite A, Davis, CA
95616), requests to establish an exemption from the requirement of a
tolerance in 40 CFR part 180 for residues of the bactericide
bacteriophages active against Xylella fastidiosa in or on all food
commodities. The petitioner believes no analytical method is needed
because an exemption from the requirement of a tolerance is being
proposed. Contact: BPPD.
    3. PP 7F8573. (EPA-HQ-OPP-2017-0702). OmniLytics, Inc., 9100 South
500 West, Sandy, UT 84070, requests to establish an exemption from the
requirement of a tolerance in 40 CFR part 180 for residues of the
bactericide bacteriophage active against Erwinia amylovora in or on
apple and pear. The petitioner believes no analytical method is needed
because an exemption from the requirement of a tolerance is being
proposed. Contact: BPPD.
    4. PP 7F8589. (EPA-HQ-OPP-2017-0722). Adjuvants Plus, Inc., 1755
Division Rd. North, Kingsville, Ontario N9Y 2Y8, Canada (c/o Technology
Sciences Group Inc., 712 Fifth St., Suite A, Davis, CA 95616), requests
to establish an exemption from the requirement of a tolerance in 40 CFR
part 180 for residues of the fungicide Clonostachys rosea strain ACM941
in or on all food commodities. The petitioner believes no analytical
method is needed because an analytical method for residues is not
applicable; it is expected that, when used as proposed, Clonostachys
rosea strain ACM941 would not result in residues that are of
toxicological concern. Contact: BPPD.
    5. PP 7F8594. (EPA-HQ-OPP-2017-0721). Adjuvants Plus, Inc., 1755
Division Rd. North, Kingsville, Ontario N9Y 2Y8, Canada (c/o Technology
Sciences Group Inc., 712 Fifth St., Suite A, Davis, CA 95616), requests
to establish an exemption from the requirement of a tolerance in 40 CFR
part 180 for residues of the fungicide Clonostachys rosea strain 88-710
in or on all food commodities. The petitioner believes no analytical
method is needed because an analytical method for residues is not
applicable; it is expected that, when used as proposed, Clonostachys
rosea strain 88-710 would not result in residues that are of
toxicological concern. Contact: BPPD.

V. New Tolerances for Non-Inerts

    1. PP 7F8577. EPA-HQ-OPP-2017-0719. Sipcam Agro USA, 2525 Meridian
Parkway, Suite 350, Durham, NC 27713, requests to establish a tolerance
in 40 CFR part 180.275 for residues of the fungicide, chlorothalonil in
or on sugarbeet roots at 0.5 ppm; sugarbeet, dried pulp at 0.05 ppm;
sugarbeet, refined sugar at 0.05 ppm; sugarbeet, molasses at 0.05 ppm.
The gas chromatography method is used to measure and evaluate the
chemical chlorothalonil. Contact: RD.
    2. PP 7F8582. (EPA-HQ-OPP-2017-0417). FMC Corporation, 1735 Market
Street, Philadelphia, PA 19103 requests to establish a tolerance in 40
CFR 180 for residues of the fungicide, valifenalate, in or on the raw
agricultural commodity potato at 0.01 ppm; bulb vegetable crop group 3-
07 at 0.40 ppm; celery at 5.0 ppm; cucurbit crop group 9 at 0.30 ppm;
fruiting vegetable crop group 8-10 at 0.50 ppm; grape import tolerance
at 5.0 ppm; and tomato-wet peel at 0.90 ppm. The LC/MS/MS method is
used to measure and evaluate the chemical valifenalate (beta-Alanine,
N-[(1-methylethoxy)carbonyl]-L-valyl-3-(4-chlorophenyl)-, methyl
ester). Contact: RD.
    3. PP 7F8618. (EPA-HQ-OPP-2017-0673). Gowan Company, LLC, P.O. Box
556 Yuma, AZ 85364, requests to establish a tolerance in 40 CFR part
180 for residues of the insecticide fenazaquin, [3-[2-[4-(1,1-
dimethylethyl) phenyl] ethoxy] quinazoline], in or on Alfalfa, forage,
at 4.0 ppm; Alfalfa, hay, at 15 ppm; Avocado at 0.15 ppm; Beef, fat at
0.05 ppm; Bushberry, subgroup 13-07B at 0.8 ppm; Caneberry, subgroup
13-07A at 0.7 ppm; Corn, field, aspirated grain fractions at 3.0 ppm;
Corn, field, forage at 7.0 ppm; Corn, field, grain at 0.09 ppm; Corn,
field, refined oil at 0.2 ppm; Corn, field, stover at 40 ppm; Corn,
sweet, forage at 9.0 ppm; Corn, sweet, grain at 0.03 ppm; Cotton, gin
byproducts at 15.0 ppm; Cotton, undelinted seed at 0.4 ppm; Fruit,
citrus group 10-10 at 0.4 ppm; Fruit, low growing berry subgroup 13-07G
at 2.0 ppm; Fruit, pome group 11-10 at 0.4 ppm; Fruit, small fruit vine
climbing, except fuzzy kiwifruit subgroup 13-07F at 0.7 ppm; Fruit,
stone group 12-12 at 1.5 ppm; Grape, raisins at 0.8 ppm; Kidney at 0.01
ppm; Liver at 0.02 ppm; Milk at 0.01 ppm; Mint at 10.0 ppm; Pork, fat
at 0.05 ppm; Sheep, fat at 0.05 ppm; Vegetables, cucurbit group 9 at
0.3 ppm; Vegetables, fruiting group 8-10 at 0.3 ppm; Vegetables,
legumes, dried shelled pea and bean (except soybean) subgroup 6C at 0.3
ppm; Vegetables, legumes, edible-podded subgroup 6A at 0.4 ppm; and
Vegetables, legumes, succulent shelled pea and bean subgroup 6B at 0.02
ppm. LC/MS/MS is used to measure and evaluate the chemical fenazaquin.
Contact: RD.
    4. PP 7F8623. (EPA-HQ-OPP-2017-0653). Nippon Soda Co., Ltd c/o
Nisso America, Inc., 88 Pine Street, 14th Floor, New York, NY 10005
requests to establish a tolerance in 40 CFR for residues of the
fungicide picarbutrazox, in or on Crop Group 9, Cucurbit Vegetables at
0.20 ppm, Crop Subgroup 4-16A, Leafy Greens at 10 ppm, Corn, forage at
0.01 ppm, Corn, grain at 0.01 ppm, Corn, stover at 0.01 ppm, Corn,
sweet, forage at 0.01 ppm, Corn, sweet, kernel plus cob with husks
removed at 0.01 ppm, Corn, sweet, stover at 0.01 ppm, Popcorn, grain at
0.01 ppm, Soybean, forage at 0.01 ppm, Soybean, hay at 0.01 ppm and
Soybean, seed at 0.01 ppm. The LC/MS/MS method is

used to measure and evaluate the chemical picarbutrazox (tert-butyl (6-
{[(Z)-(1-methyl-1H-5-tetrazolyl)
(phenyl)methylene]aminooxymethyl{time} -2-pyridyl)carbamate) and its
metabolite TZ-1E (IUPAC: tert-butyl (6-{[(E)-(1-methyl-1H-5-tetrazolyl)
(phenyl)methylene]aminooxymethyl{time} -2-pyridyl) carbamate). Contact:
RD.

    Authority: 21 U.S.C. 346a.

    Dated: January 29, 2018.
Hamaad A. Syed,
Acting Director, Information Technology and Resources Management
Division, Office of Pesticide Programs.
[FR Doc. 2018-04522 Filed 3-5-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 245 (Friday, December 20, 2019)]
[Rules and Regulations]
[Pages 69997-70000]
[FR Doc No: 2019-27467]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0698; Product Identifier 2019-NM-109-AD; Amendment
39-19814; AD 2019-24-11]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Airplanes

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

ACTION: Final rule.

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

SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2014-16-26
and AD 2017-19-04, which applied to certain Dassault Aviation Model
FALCON 900EX airplanes. Those ADs required revising the existing
maintenance or inspection program, as applicable, to incorporate new or
more restrictive maintenance requirements and/or airworthiness
limitations. Since the FAA issued AD 2014-16-26 and AD 2017-19-04, the
FAA determined that new or more restrictive airworthiness limitations
are necessary. This AD continues to require those maintenance or
inspection program revisions, and also requires revising the existing
maintenance or inspection program, as applicable, to incorporate
additional 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 January 24, 2020.

    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 24,
2020.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of
October 19, 2017 (82 FR 43163, September 14, 2017).

ADDRESSES: For service information identified in this final rule,
contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box
2000, South Hackensack, NJ 07606; telephone<PHONE_NUMBER>; internet
https://www.dassaultfalcon.com. You may view this referenced service
information at the FAA, Transport Standards 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 on the
internet at https://www.regulations.gov by searching for and locating
Docket No. FAA-2019-0698.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0698; 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 regulatory evaluation, 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.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Union, has issued
EASA AD 2019-0133, dated June 11, 2019 (``EASA AD 2019-0133'') (also
referred to as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for certain Dassault
Aviation Model FALCON 900EX airplanes. You may examine the MCAI in the
AD docket on the internet at https://www.regulations.gov by searching
for and locating Docket No. FAA-2019-0698.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2014-16-26, Amendment 39-17950 (79 FR
51077, August 27, 2014) (``AD 2014-16-26''); and AD 2017-19-04,
Amendment 39-19034 (82 FR 43163, September 14, 2017) (``AD 2017-19-
04''). AD 2014-16-26 and AD 2017-19-04 applied to certain Dassault
Aviation Model FALCON 900EX airplanes. The NPRM published in the
Federal Register on September 16, 2019 (84 FR 48569). The NPRM was
prompted by the FAA's determination that new or more restrictive
airworthiness limitations are necessary. The NPRM proposed to continue
to require revising the existing maintenance or inspection program, as
applicable; and to require additional revision of the existing
maintenance or inspection program, as applicable; to incorporate new or
more restrictive airworthiness limitations. The FAA is issuing this AD
to address reduced structural integrity of the airplane. See the MCAI
for additional background information.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA received no comments on the NPRM or
on the determination of the cost to the public.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
and the public interest require adopting this final rule as proposed,
except for minor editorial changes. The FAA determined that these minor
changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Dassault Aviation has issued Chapter 5-40, Airworthiness
Limitations, Revision 16, dated September 2018, of the Dassault FALCON
900EX Maintenance Manual. This service information describes
procedures, maintenance tasks, and airworthiness limitations specified
in the Airworthiness Limitations section of the Airplane Maintenance
Manual.
    This AD also requires Chapter 5-40, Airworthiness Limitations,
Revision 14, dated November 2015, of the FALCON 900EX Maintenance
Manual, which the Director of the Federal Register approved for
incorporation by reference as of October 19, 2017 (82 FR 43163,
September 14, 2017).
    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 100 airplanes of U.S.
registry.
    The FAA estimates the following costs to comply with this AD:
    The FAA estimates the total cost per operator for the retained
actions from AD 2017-19-04 to be $7,650 (90 work-hours x $85 per work-
hour).
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the agency 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. The FAA estimates the total cost per operator for
the new actions to be $7,650 (90 work-hours x $85 per work-hour).

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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs

applicable to transport category airplanes and associated appliances to
the Director of the System Oversight Division.

Regulatory Findings

    The FAA determined that 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.

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) 2014-16-26, Amendment 39-17950
(79 FR 51077, August 27, 2014); and AD 2017-19-04, Amendment 39-19034
(82 FR 43163, September 14, 2017); and
0
b. Adding the following new AD:

2019-24-11 Dassault Aviation: Amendment 39-19814; Docket No. FAA-
2019-0698; Product Identifier 2019-NM-109-AD.

(a) Effective Date

    This AD is effective January 24, 2020.

(b) Affected ADs

    (1) This AD replaces AD 2014-16-26, Amendment 39-17950 (79 FR
51077, August 27, 2014) (``AD 2014-16-26''); and AD 2017-19-04,
Amendment 39-19034 (82 FR 43163, September 14, 2017) (``AD 2017-19-
04'').
    (2) This AD affects AD 2010-26-05, Amendment 39-16544 (75 FR
79952, December 21, 2010) (``AD 2010-26-05'').

(c) Applicability

    This AD applies to Dassault Aviation Model FALCON 900EX
airplanes, certificated in any category, serial numbers 1 through 96
inclusive, and serial numbers 98 through 119 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
issuing this AD to address reduced structural integrity of the
airplane.

(f) Compliance

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

(g) Retained Revision of Maintenance or Inspection Program, With No
Changes

    This paragraph restates the requirements of paragraph (g) of AD
2017-19-04, with no changes. Within 90 days after October 19, 2017
(the effective date of AD 2017-19-04), revise the existing
maintenance or inspection program, as applicable, to incorporate the
information specified in Chapter 5-40, Airworthiness Limitations,
Revision 14, dated November 2015, of the FALCON 900EX Maintenance
Manual. The initial compliance time for accomplishing the actions
specified in Chapter 5-40, Airworthiness Limitations, Revision 14,
dated November 2015, of the FALCON 900EX Maintenance Manual, is
within the applicable times specified in the maintenance manual, or
90 days after October 19, 2017, whichever occurs later, except as
provided by paragraphs (g)(1) through (4) of this AD.
    (1) The term ``LDG'' in the ``First Inspection'' column of any
table in the service information means total airplane landings.
    (2) The term ``FH'' in the ``First Inspection'' column of any
table in the service information means total flight hours.
    (3) The term ``FC'' in the ``First Inspection'' column of any
table in the service information means total flight cycles.
    (4) The term ``M'' in the ``First Inspection'' column of any
table in the service information means months.

(h) Retained Requirement for No Alternative Actions and Intervals, With
New Exception

    This paragraph restates the requirement specified in paragraph
(h) of AD 2017-19-04, with a new exception. Except as required by
paragraph (i) of this AD, after accomplishing the revision required
by paragraph (g) of this AD, no alternative actions (e.g.,
inspections) or intervals may be used unless the actions or
intervals are approved as an alternative method of compliance (AMOC)
in accordance with the procedures specified in paragraph (l)(1) of
this AD.

(i) New Requirement of This AD: Maintenance or Inspection Program
Revision

    Within 90 days after the effective date of this AD, revise the
existing maintenance or inspection program, as applicable, to
incorporate the information specified in Chapter 5-40, Airworthiness
Limitations, Revision 16, dated September 2018, of the Dassault
FALCON 900EX Maintenance Manual. The initial compliance times for
accomplishing the actions are at the times specified in Chapter 5-
40, Airworthiness Limitations, Revision 16, dated September 2018, or
90 days after the effective date of this AD, whichever occurs later,
except as provided by paragraphs (i)(1) through (4) of this AD.
    (1) The term ``LDG'' in the ``First Inspection'' column of any
table in the service information means total airplane landings.
    (2) The term ``FH'' in the ``First Inspection'' column of any
table in the service information means total flight hours.
    (3) The term ``FC'' in the ``First Inspection'' column of any
table in the service information means total flight cycles.
    (4) The term ``M'' in the ``First Inspection'' column of any
table in the service information means months since the date of
issuance of the original airworthiness certificate or the date of
issuance of the original export certificate of airworthiness.

(j) No Alternative Actions or Intervals

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

(k) Terminating Actions for Certain Actions in AD 2010-26-05

    Accomplishing the actions required by paragraph (g) or (i) of
this AD terminates the requirements of paragraph (g)(1) of AD 2010-
26-05, for Dassault Aviation Model FALCON 900EX airplanes, serial
numbers 1 through 96 inclusive, and serial numbers 98 through 119
inclusive.

(l) Other FAA AD Provisions

    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards 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 International Section, send it to the attention of
the person identified in paragraph (m)(2) of this AD. Information
may be emailed to<EMAIL_ADDRESS>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.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement

in this AD to obtain corrective actions from a manufacturer, the
action must be accomplished using a method approved by the Manager,
International Section, Transport Standards Branch, FAA; or the
European Union Aviation Safety Agency (EASA); or Dassault Aviation's
EASA Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.

(m) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2019-0133, dated June 11, 2019, for related
information. This MCAI may be found in the AD docket on the internet
at https://www.regulations.gov by searching for and locating Docket
No. FAA-2019-0698.
    (2) For more information about this AD, contact Tom Rodriguez,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.

(n) 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.
    (3) The following service information was approved for IBR on
January 24, 2020.
    (i) Chapter 5-40, Airworthiness Limitations, Revision 16, dated
September 2018, of the Dassault FALCON 900EX Maintenance Manual.
    (ii) [Reserved]
    (4) The following service information was approved for IBR on
October 19, 2017 (82 FR 43163, September 14, 2017).
    (i) Chapter 5-40, Airworthiness Limitations, Revision 14, dated
November 2015, of the FALCON 900EX Maintenance Manual.
    (ii) [Reserved]
    (5) For service information identified in this AD, contact
Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000,
South Hackensack, NJ 07606; telephone<PHONE_NUMBER>; internet https://www.dassaultfalcon.com.
    (6) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (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 in Des Moines, Washington, on November 27, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-27467 Filed 12-19-19; 8:45 am]
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