[Federal Register Volume 86, Number 122 (Tuesday, June 29, 2021)]
[Rules and Regulations]
[Pages 34142-34145]
[FR Doc No: 2021-13804]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0474; FRL-10025-18]

Bacillus subtilis Strain RTI477; Exemption From the Requirement
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Bacillus subtilis strain RTI477 in or on
all food commodities when used in accordance with label directions and
good agricultural practices. FMC Corporation submitted a petition to
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting
an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of Bacillus subtilis strain RTI477 under FFDCA when used in
accordance with this exemption.

DATES: This regulation is effective June 29, 2021. Objections and
requests for hearings must be received on or before August 30, 2021 and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0474, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

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

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2019-0474 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
August 30, 2021. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b), although EPA
strongly encourages those interested in submitting objections or a
hearing request, to submit objections and hearing requests
electronically. See Order Urging Electronic Service and Filing (April
10, 2020), https://www.epa.gov/sites/production/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.
At this time, because of the COVID-19 pandemic, the judges and staff of
the Office of Administrative Law Judges are working remotely and not
able to accept filings or correspondence by courier, personal delivery,
or commercial delivery, and the ability to receive filings or
correspondence by U.S. Mail is similarly limited. When submitting
documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a
person should utilize the OALJ e-filing system, at https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf.
    Although EPA's regulations require submission via U.S. Mail or hand
delivery, EPA intends to treat submissions filed via electronic means
as properly filed submissions during this time that the Agency
continues to maximize telework due to the pandemic; therefore, EPA
believes the preference for submission via electronic means will not be
prejudicial. If it is impossible for a person to submit documents
electronically or receive service electronically, e.g., the person does
not have any access to a computer, the person shall so advise OALJ by
contacting the Hearing Clerk at<PHONE_NUMBER>. If a person is without
access to a computer and must file documents by U.S. Mail, the person
shall notify the Hearing Clerk every time it files a document in such a
manner. The address for mailing documents is U.S. Environmental
Protection Agency, Office of Administrative Law Judges, Mail Code
1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2019-0474, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of February 4, 2020 (85 FR 6129) (FRL-
10003-17), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
exemption petition (PP 9F8749) by FMC Corporation, 2929 Walnut St.,
Philadelphia, PA 19104. The petition requested that 40 CFR part 180 be
amended by establishing an exemption from the requirement of a
tolerance for residues of the fungicide Bacillus subtilis strain RTI477
in or on all food commodities. That notice referenced a summary of the
petition prepared by the petitioner FMC Corporation and available in
the docket via http://www.regulations.gov. No comments were received on
the notice of filing.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA

determines that the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of
FFDCA defines ``safe'' to mean that ``there is a reasonable certainty
that no harm will result from aggregate exposure to the pesticide
chemical residue, including all anticipated dietary exposures and all
other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings
but does not include occupational exposure. Pursuant to FFDCA section
408(c)(2)(B), in establishing or maintaining in effect an exemption
from the requirement of a tolerance, EPA must take into account the
factors set forth in FFDCA section 408(b)(2)(C), which require EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance or tolerance
exemption and to ``ensure that there is a reasonable certainty that no
harm will result to infants and children from aggregate exposure to the
pesticide chemical residue. . . .'' Additionally, FFDCA section
408(b)(2)(D) requires that EPA consider ``available information
concerning the cumulative effects of [a particular pesticide's] . . .
residues and other substances that have a common mechanism of
toxicity.''
    EPA evaluated the available toxicological and exposure data on
Bacillus subtilis strain RTI477 and considered their validity,
completeness, and reliability, as well as the relationship of this
information to human risk. A full explanation of the data upon which
EPA relied and its risk assessment based on those data can be found
within the document entitled ``Human Health Risk Assessment for the New
Active Ingredients Bacillus subtilis strain RTI477 and Bacillus
velezensis strain RTI301 in the Proposed Manufacturing-use Products
279-OAUT, 279-OAUI and End-use Products 279-OAUO, 279-OALN and 279-OALR
for FIFRA Section 3 Registration with Tolerance Exemption Petitions''
(Bacillus subtilis strain RTI477 and Bacillus velezensis strain RTI301
Human Health Assessment). This document, as well as other relevant
information, is available in docket for this action as described under
ADDRESSES.
    The available data demonstrated that, with regard to humans,
Bacillus subtilis strain RTI477 is not toxic via the pulmonary, oral,
or dermal routes of exposure and is not pathogenic or infective via the
pulmonary route of exposure. Although there may be some dietary and
non-occupational exposures to residues of Bacillus subtilis strain
RTI477 when used in accordance with label directions and good
agricultural practices, there is not a concern due to the lack of
potential for adverse effects. Because there are no threshold levels of
concern with the toxicity, pathogenicity, or infectivity of Bacillus
subtilis strain RTI477, EPA determined that no additional margin of
safety is necessary to protect infants and children as part of the
qualitative assessment conducted. Based upon its evaluation in the
Bacillus subtilis strain RTI477 and Bacillus velezensis strain RTI301
Human Health Assessment, which concludes that there are no risks of
concern from aggregate exposure to Bacillus subtilis strain RTI477, EPA
concludes that there is a reasonable certainty that no harm will result
to the U.S. population, including infants and children, from aggregate
exposure to residues of Bacillus subtilis strain RTI477.

B. Analytical Enforcement Methodology

    An analytical method is not required for Bacillus subtilis strain
RTI477 because EPA is establishing an exemption from the requirement of
a tolerance without any numerical limitation.

C. Conclusion

    Therefore, an exemption from the requirement of a tolerance is
established for residues of Bacillus subtilis strain RTI477 in or on
all food commodities when used in accordance with label directions and
good agricultural practices.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to EPA. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance
exemption in this action, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601
et seq.) do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, EPA has determined that this
action will not have a substantial direct effect on States or Tribal
Governments, on the relationship between the National Government and
the States or Tribal Governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian Tribes. Thus, EPA has determined that
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10,
1999), and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), do not apply to this action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (2 U.S.C.
1501 et seq.).
    This action does not involve any technical standards that would
require EPA's consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (15 U.S.C. 272 note).

V. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: June 21, 2021.
Edward Messina,
Acting Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

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

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

0
2. Add Sec.  180.1384 to subpart D to read as follows:

Sec.  180.1384  Bacillus subtilis strain RTI477; exemption from the
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of Bacillus subtilis strain RTI477 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.

[FR Doc. 2021-13804 Filed 6-28-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 51 (Thursday, March 18, 2021)]
[Notices]
[Pages 14750-14751]
[FR Doc No: 2021-05628]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0693 and EPA-HQ-OPP-2019-0161; FRL-10019-54]

Final Test Guidelines; OCSPP Series 810--Product Performance Test
Guidelines; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of the final product performance test guidelines for fire
ants and invertebrate pests of pets. These test guidelines are part of
a series of test guidelines established by the Office of Chemical
Safety and Pollution Prevention (OCSPP) for use in testing pesticides
and chemical substances. The test guidelines serve as a compendium of
accepted scientific methodologies and protocols for testing that are
intended to provide data to inform regulatory decisions. These test
guidelines, which are identified as OCSPP Test Guideline 810.3100 and
810.3300, provide guidance for conducting a study to determine
pesticide product performance against fire ants and invertebrate pests
of pets, respectively, and are used by EPA, the public, and companies
that submit data to EPA.

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

I. Introduction

    EPA is announcing the availability of the following final test
guidelines: OCSPP Test Guideline 810.3100: Treatments for Imported Fire
Ants and 810.3300: The Efficacy of Topically Applied Pet Products
Against Certain Invertebrate Pests.
    These test guidelines are part of a series of test guidelines
established by OCSPP for use in testing pesticides and chemical
substances to develop data for submission to the Agency under the
Federal Food, Drug, and Cosmetic Act (FFDCA) section 408 (21 U.S.C.
346a), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
(7 U.S.C. 136 et seq.), and the Toxic Substances Control Act (TSCA) (15
U.S.C. 2601 et seq.). The test guidelines serve as a compendium of
accepted scientific methodologies and protocols that are intended to
provide data to inform regulatory decisions under TSCA, FIFRA, and/or
FFDCA.
    The test guidelines are used by EPA, the public, and companies that
are subject to data submission requirements under TSCA, FIFRA, and/or
FFDCA. As guidance documents, the test guidelines are not binding on
either EPA or any outside parties, and EPA may depart from the test
guidelines where circumstances warrant and without prior notice. At
places in this guidance, the Agency uses the word ``should.'' In this
guidance, use of ``should'' with regard to an action means that the
action is recommended rather than mandatory. The procedures contained
in the test guidelines are recommended for generating the data that are
the subject of the test guideline, but EPA recognizes that departures
may be appropriate in specific situations. You may propose alternatives
to the recommendations described in the test guidelines, and the Agency
will assess them for appropriateness on a case-by-case basis.

II. General Information

A. Does this action apply to me?

    This action is directed to the public in general. Although this
action may be of particular interest to those persons who are or may be
required to conduct testing of pesticides and chemical substances for
submission to EPA under TSCA, FIFRA, and/or FFDCA, the Agency has not
attempted to describe all the specific entities that may be affected by
this action.

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

    1. Docket for this document. The dockets for this action,
identified by docket identification (ID) numbers EPA-HQ-OPP-2017-0693
and EPA-HQ-OPP-2019-0161, are available at http://www.regulations.gov
or at the Office of Pesticide Programs Regulatory Public Docket (OPP
Docket) in the Environmental Protection Agency Docket Center (EPA/DC),
West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave.
NW, Washington, DC 20460-0001. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Due to the public health emergency, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
    2. Electronic access to the OCSPP test guidelines. To access OCSPP
test guidelines electronically, please go to http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm. You may also access the test guidelines in
http://www.regulations.gov, grouped by series under docket ID numbers:
EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159 and EPA-HQ-OPPT-
2009-0576.

III. Overview

A. What action is EPA taking?

    EPA is announcing the availability of final test guidelines under
Series 810.3100 entitled ``Treatments for Imported Fire Ants'' and
identified as OCSPP Test Guideline 810.3100, and Series 810.3300
entitled ``The Efficacy of Topically Applied Pet Products Against
Certain Invertebrate Pests'' and identified as OCSPP Test Guideline
810.3300. These revised guidelines replace the original versions
published in 1998. The guidelines provide recommendations for the
design and execution of studies to evaluate the performance of
pesticide products intended for use against fire ants and invertebrate
pests of pests, such as fleas, ticks, and mosquitoes, in connection
with registration of pesticide products under the FIFRA (7 U.S.C. 136,
et seq.).

B. How were these final test guidelines developed?

    EPA-registered pesticide products are an important part of pest
management programs for pests of pets and premises. The Agency
developed the product performance test guidelines to standardize the
approaches to testing methods to ensure the quality and validity of the
efficacy data for these types of products. The Agency attended
entomology conferences, consulted with leading academics, and reviewed
peer-reviewed scientific journal articles on topics related to the
guideline to draft the original document. Further, EPA sought advice
and recommendations from FIFRA Scientific Advisory Panels (SAPs) and
the public. The SAP meetings, held on May 8-10, 2018, and June 11-14,
2019, were announced in the Federal Register issues of January 26, 2018
(83 FR 3704) (FRL-9972-65) and April 15, 2019 (84 FR 15214) (FRL-9991-
80), respectively. These guidelines

have been revised based on comments from the SAPs and the public. The
revisions to the fire ant guideline include the expansion of the
guideline applicability to other ants in the Solenopsis saevissima
complex, removal of the need to test in multiple geographically
distinct locations and with both social forms of fire ants, inclusion
of additional options for both field and laboratory test designs, and
decreasing the number of ants needed for laboratory tests. The
revisions to the pet product guideline include decreasing the number of
animals used for tick testing, simplifying the tick test data
collection categories, removing dead pest counts in favor of live pest
counts, and revising the negative control for shampoo treatments from a
placebo control to an untreated control. The Agency is also making
available in the dockets the Response to Comments documents that
address issues raised in the public comment submissions.

C. Do guidance documents contain binding requirements?

    As guidance, the test guidelines are not binding on the Agency or
any outside parties, and the Agency may depart from it where
circumstances warrant and without prior notice. While EPA has made
every effort to ensure the accuracy of the discussion in the guidance,
the obligations of EPA and the regulated community are determined by
statutes, regulations, or other legally binding documents. In the event
of a conflict between the discussion in the guidance document and any
statute, regulation, or other legally binding document, the guidance
document will not be controlling.

IV. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders. This unit addresses those requirements that apply to
a guidance document.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    The Office of Management and Budget (OMB) determined that the final
test guideline documents are not significant regulatory actions under
Executive Order 12866 (58 FR 51735, October 4, 1993). The final
guidelines were not, therefore, submitted to OMB for review under
Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    These test guidelines do not create paperwork burdens that require
additional approval by OMB under the PRA, 44 U.S.C. 3501 et seq. The
information collection activities associated with pesticide
registration are already approved by OMB under OMB Control No. 2070-
0060.

    Authority: 7 U.S.C. 136 et seq.; 15 U.S.C. 2601 et seq.; 21
U.S.C. 301 et seq.

    Dated: March 10, 2021.
Michal Freedhoff,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2021-05628 Filed 3-17-21; 8:45 am]
BILLING CODE 6560-50-P


Section 2. Sample Collection Information Section 3. Sample Process Dates, Times, and Temperatures Section 4. Number of Colony Forming Units and Calculations Section 5. Comments 1Ground water under the direct influence of surface water Long Term 2 Enhanced Surface Water Treatment Rule Source Water Monitoring Method Type: Membrane Filtration Analytical Method Number: EPA Method 1603 ( Modified mTEC)

RESULTS modified mTEC incubation start modified mTEC incubation end Time:

E. coli 4 E. coli per 100 mL Number of E. coli CFU Analyst initials mL of sample filtered 3 2 Filter no.

1 Section 1. Laboratory Identification Information Laboratory name: Laboratory ID:

Sample ID ( optional): Sample collection date:

PWS ID: Sample collection time:

PWS facility ID: Holding time:

Sample collection point ID: Turbidity result ( NTU):

Source water type ( circle one): Flowing stream ( FS) Reservoir/ lake ( RL) 1GWUDI FS 1GWUDI RL Date:

Temperature ( oC): Date:

Time:

Temperature ( oC):

Draft June 2003


[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Notices]
[Pages 29216-29217]
[FR Doc No: 2019-13220]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0021]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Substances Generally
Recognized as Safe: Notification Procedure

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by July
22, 2019.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0342.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Substances Generally Recognized as Safe (GRAS): Notification
Procedure--21 CFR Part 170, Subpart E and 21 CFR Part 570, Subpart E

OMB Control Number 0910-0342--Extension

    The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that
all food additives (as defined by section 201(s) (21 U.S.C. 321(s)) be
approved by FDA before they are marketed. Section 409 of the FD&C Act
(21 U.S.C. 349) establishes a premarket approval requirement for ``food
additives.'' Section 201(s) of the FD&C Act provides an exclusion to
the definition of food additive and thus from the premarket approval
requirement, for uses of substances that are GRAS by qualified experts.
The GRAS provision of section 201(s) of the FD&C Act is implemented in
(part 170) 21 CFR part 170 and (part 570) 21 CFR part 570 for human
food and animal food, respectively. Part 170, subpart E and part 570,
subpart E provide a standard format for the submission of a notice.
This collection utilizes a voluntary administrative procedure for
notifying FDA about a conclusion that a substance is GRAS under the
conditions of its intended use in human food or animal food. The
information submitted to us in a GRAS notice is necessary to allow us
to administer efficiently the FD&C Act's various provisions that apply
to the use of substances added to food, specifically with regard to
whether a substance is GRAS under the conditions of its intended use or
is a food additive subject to premarket review. We use the information
collected through the GRAS notification procedures to complete our
evaluation within specific timelines.
    Description of Respondents: The respondents to this collection of
information are manufacturers of substances used in human food and
animal food and feed.
    In the Federal Register of March 12, 2019 (84 FR 8876), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received. We estimate the
burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    Activity; 21 CFR section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
GRAS notification procedure for              100               1             100             170          17,000
 human food; 170.210-170.280
 (part 170, subpart E)..........
GRAS notification procedure for               25               1              25             170           4,250
 animal food and animal feed;
 570.210-570.280 (part 570,
 subpart E).....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............              75  ..............          21,250
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden reflects an overall increase of 8,500 hours,
which corresponds to an increase in GRAS submissions for human food
from 50 to 100 we have received over the last 2 years.

    Dated: June 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13220 Filed 6-20-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 57 (Friday, March 23, 2012)]
[Notices]
[Pages 17105-17107]
[FR Doc No: 2012-7124]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2012-0086]

Identification of Interstate Motor Vehicles: City of Chicago, IL
Registration Emblem Requirement; Petition for Determination

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of Petition for Determination; Request for Comments.

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

SUMMARY: FMCSA invites all interested persons to comment on a petition
submitted by Allerton Charter Coach, Inc. (Allerton) requesting a
determination that the Commercial Motor Vehicle (CMV) identification
requirement imposed by the Chicago Ground Transportation Tax is
preempted by Federal law. Federal law prohibits States and their
political subdivisions from requiring motor carriers to display in or
on CMVs any form of identification other than forms required by the
Secretary of Transportation, with certain exceptions. FMCSA seeks
comment on whether the credential display requirement described below
is preempted or whether it qualifies for an exception.

DATES: Comments are due on or before May 22, 2012.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System Number in the heading of this document by any of the
following methods. Do not submit the same comments by more than one
method. However, to allow effective

public participation before the comment period deadline, the Agency
encourages use of the Web site that is listed first. It will provide
the most efficient and timely method of receiving and processing your
comments.
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Fax: 1-202-493-2251.
     Mail: Docket Management Facility; U.S. Department of
Transportation, Room W12-140, 1200 New Jersey Avenue SE., Washington,
DC 20590-0001.
     Hand Delivery: Ground floor, Room W12-140, 1200 New Jersey
Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday
through Friday, except Federal holidays.
    Instructions: All submissions must include the Agency name and
docket number for this action. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Refer to the Privacy Act heading on
http://www.regulations.gov for further information.
    Public Participation: The regulations.gov system is generally
available 24 hours each day, 365 days each year. You can find
electronic submission and retrieval help and guidelines under the
``Help'' section of the Web site. For notification that FMCSA received
the comments, please include a self-addressed, stamped envelope or
postcard, or print the acknowledgement page that appears after
submitting comments on line. Copies or abstracts of all documents
referenced in this Notice are in this docket. For access to the docket
to read background documents or comments received, go to http://www.regulations.gov at any time or to Room W12-140, 1200 New Jersey
Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday
through Friday, except Federal holidays. All comments received before
the close of business on the comment closing date indicated above will
be considered and will be available for examination in the docket at
the above address. Comments received after the closing date will be
considered to the extent practicable. FMCSA may, however, issue a final
determination at any time after the close of the comment period. In
addition to late comments, FMCSA will also continue to file in the
public docket relevant information that becomes available after the
comment closing date. Interested persons should monitor the public
docket for new material.

FOR FURTHER INFORMATION CONTACT: Genevieve D. Sapir, Office of the
Chief Counsel, Federal Motor Carrier Safety Administration, 1200 New
Jersey Avenue SE., Washington, DC 20590,<PHONE_NUMBER>; email
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Background

    On January 20, Allerton submitted a petition requesting that FMCSA
determine that the Chicago Ground Transportation Tax's (the Tax)
registration emblem display requirement, which applies to interstate
passenger motor carriers under FMCSA's jurisdiction, is preempted by 49
U.S.C. 14506. On February 9, the City of Chicago responded to the
petition, stating that it would file public comments in response to
this Notice.
    The Tax requires providers of passenger ground transportation
within the City of Chicago to register their vehicles and pay a
graduated fee that varies according to the seating capacity of each
vehicle registered. Chicago Mun. Code ch. 3-46. The Tax applies to all
for-hire vehicles used to pick up, drop off or both pick up and drop
off passengers within the city. Chicago Mun. Code Sec.  3-46-020(H).
These vehicles include, but are not limited to: Water taxis, horse-
drawn carriages and taxicabs, and all automobiles, limousines, buses
and other vehicles used to provide passenger transportation for a
charge. Chicago Mun. Code Sec.  3-46-020(D). The Tax applies regardless
of whether the vehicle in question is registered or titled with the
State of Illinois. Id. To prevent multiple taxation, most providers of
for-hire passenger transportation who are required to pay a similar tax
in another municipality may claim a credit by the amount paid to the
other municipality. Chicago Mun. Code Sec.  3-46-030(C)(1).
    Vehicles subject to the Tax must display an emblem on the
windshield as evidence of registration and payment. Chicago Mun. Code
Sec.  3-46-073(A), (B). Vehicles that do not display the emblem are
prohibited from operating within the city and are subject to seizure
and impoundment at the vehicle owner's expense, as well as an
administrative penalty of $500. Id.; Chicago Mun. Code Sec.  3-46-
076(A).
    Federal law, codified at 49 U.S.C. 14506(a), prohibits States from
requiring interstate motor carriers to display in or on CMVs any form
of identification other than forms required by the Secretary of
Transportation (Secretary). Section 14506(b), however, establishes the
following exceptions to this prohibition [all statutory references are
to title 49, United States Code]:

    (b) Exception.--Notwithstanding subsection (a), a State may
continue to require display of credentials that are required--
    (1) Under the International Registration Plan under section
31704;
    (2) Under the International Fuel Tax Agreement under section
31705 or under an applicable State law if, on October 1, 2006, the
State has a form of highway use taxation not subject to collection
through the International Fuel Tax Agreement;
    (3) Under a State law regarding motor vehicle license plates or
other displays that the Secretary determines are appropriate;
    (4) In connection with Federal requirements for hazardous
materials transportation under section 5103; or
    (5) In connection with the Federal vehicle inspection standards
under section 31136.

    FMCSA interprets Sec.  14506(b)(3) to establish two categories of
excepted requirements. The first includes identification requirements
related to motor vehicle license plates. The second includes any other
identification displays that the Secretary of Transportation approves.
49 U.S.C. 14506(b)(3). In addition, in accordance with a previous
decision, FMCSA interprets all of the exceptions at Sec.  14506(b) to
apply to political subdivisions of States, including municipalities.
See Identification of Interstate Motor Vehicles: New York City, Cook
County, and New Jersey Identification Requirements; Petition for
Determination (75 FR 64779, Oct. 20, 2010). All authority granted to
the Secretary under Sec.  14506 has been delegated to the FMCSA
Administrator by 49 CFR 1.73(a)(7).

Request for comments

    FMCSA seeks comment on whether the City of Chicago's registration
emblem display requirement is preempted by Federal law. FMCSA welcomes
comments on whether any exception set forth in 49 U.S.C. 14506(b)
applies to the Tax, however the Agency believes that Sec.  14506(b)(3)
is the only exception that could apply to the Tax. As such, the Agency
specifically seeks comment on whether there is any reason FMCSA should
consider approving the requirement under Sec.  14506(b)(3).
    The Agency requests that submissions be limited to these issues and
encourages commenters to submit data or legal authorities supporting
their positions. FMCSA has no authority to review the imposition,
amounts, or collection of any taxes for which the credentials are
issued. Allerton's

petition and the City of Chicago's response are available for
inspection in the docket established for this Notice.

    Issued on: March 20, 2012.
William A. Bronrott,
Deputy Administrator.
[FR Doc. 2012-7124 Filed 3-22-12; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: November 25, 2009 (Volume 74, Number 226)]
[Rules and Regulations]
[Page 61507]
[DOCID:fr25no09-3]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0959; Airspace Docket No. 09-ASO-30]

Amendment of Class D and E Airspace; Fort Stewart (Hinesville),
GA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends the Class D and E Airspace at Fort Stewart
(Hinesville), GA, by changing the airport name from Fort Stewart,
Wright AAF, to Wright AAF (Fort Stewart)/Midcoast Regional, Fort
Stewart (Hinesville), GA. This is an administrative change and does not
affect the boundaries or operating requirements of the airspace.

DATES: Effective 0901 UTC, February 11, 2010. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    The Liberty County Airport in Hinesville, GA has closed and the
associated Class E5 airspace has been removed. As a result, Wright AAF
(Fort Stewart)/MidCoast Regional has become a joint use facility and
the name of the airport will be amended to reflect this change. This
rule will become effective on the date specified in the DATES section.
Since this is an administrative change and does not affect the
boundaries, altitudes, or operating requirements of the airspace,
notice and public comment under 5 U.S.C. 553(b) are unnecessary. Class
D and Class E airspace designations are published in paragraphs 5000
and 6005 respectively of FAA Order 7400.9T, dated August 27, 2009, and
effective September 15, 2009, which is incorporated by reference in 14
CFR 71.1. The Class D and E airspace designations listed in this
document will be published subsequently in the Order.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 changes the airport name from Fort Stewart, Wright AAF, to
Wright AAF (Fort Stewart)/Midcoast Regional, Fort Stewart, Hinesville,
GA.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace at Wright AAF (Fort Stewart)/Midcoast
Regional, Fort Stewart (Hinesville), GA.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR Part 71 as follows:

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

0
1. The authority citation for Part 71 continues to read as follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9T, Airspace Designations and Reporting
Points, signed August 27, 2009, effective September 15, 2009, is
amended as follows:

Paragraph 5000 Class D Airspace
* * * * *

ASO GA D Fort Stewart (Hinesville), GA [Amended]

Wright AAF (Fort Stewart)/Midcoast Regional, GA
    (Lat. 31[deg]53'21'' N., long. 81[deg]33'44'' W.)

    That airspace extending upward from the surface up to and
including 2,500 feet MSL within a 4.4-mile radius of Wright AAF
(Fort Stewart)/Midcoast Regional. This Class D airspace area is
effective during the specific dates and times established in advance
by Notice to Airmen. The effective days and times will thereafter be
continuously published in the Airport/Facility Directory.
* * * * *

Paragraph 6005 Class E Airspace Areas Extending Upward from 700
feet or More Above the Surface of the Earth.

* * * * *

ASO GA E5 Fort Stewart (Hinesville), GA [Amended]

Wright AAF (Fort Stewart)/Midcoast Regional, GA
    (Lat. 31[deg]53'21'' N., long. 81[deg]33'44'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of Wright AAF (Fort Stewart)/Midcoast
Regional.
* * * * *

    Issued in College Park, Georgia, on November 9, 2009.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. E9-28175 Filed 11-24-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 226 (Monday, November 23, 2020)]
[Notices]
[Pages 74736-74737]
[FR Doc No: 2020-25726]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-0943]

Elemental Impurities in Animal Drug Products--Questions and
Answers; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry #255 entitled
``Elemental Impurities in Animal Drug Products--Questions and
Answers.'' This guidance provides recommendations to sponsors regarding
the control of elemental impurities in animal drug products, including
all dosage forms and routes of administration.

DATES: The announcement of the guidance is published in the Federal
Register on November 23, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-0943 for ``Elemental Impurities in Animal Drug Products--
Questions and Answers.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Michael Brent, Center for Veterinary
Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>or
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 27, 2018 (83 FR 13134), FDA
published the notice of availability for a draft guidance entitled
``Elemental Impurities in Animal Drug Products--Questions and
Answers,'' giving interested persons until May 29, 2018, to comment on
the draft guidance. On August 15, 2018, we published a notice reopening
the comment period to October 15, 2018 (83 FR 40524). FDA received
comments on the draft guidance, and those comments were considered as
the guidance was finalized. The guidance announced in this notice
finalizes the draft guidance dated March 2018.
    This level 1 guidance is being issued consistent with FDA's good
guidance

practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on elemental impurities in animal drug
products. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required.
    However, this guidance refers to previously approved FDA
collections of information. These collections of information are
subject to review by OMB under the PRA. The collections of information
in section 512(n)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360b(n)(1)) have been approved under OMB control number 0910-
0669; the collections of information in 21 CFR part 514 have been
approved under OMB control number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry or https://www.regulations.gov.

    Dated: November 17, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25726 Filed 11-20-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 130 (Monday, July 10, 2017)]
[Notices]
[Pages 31772-31773]
[FR Doc No: 2017-14329]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2651-004.
    Applicants: Lockhart Power Company.
    Description: Updated Market Power Analysis for the Southeast Region
of Lockhart Power Company.
    Filed Date: 6/29/17.
    Accession Number: 20170629-5245.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER10-2794-022; ER12-1825 020; ER14-2672 007.
    Applicants: EDF Trading North America, LLC, EDF Energy Services,
LLC, EDF Industrial Power Services (CA), LLC.
    Description: Updated Market Power Analysis for the Northeast Region
of the EDF Sellers.
    Filed Date: 6/29/17.
    Accession Number: 20170629-5247.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER10-2881-031; ER10-1874 005; ER10-2641 030; ER10-

2663 031; ER10-2882 033; ER10-2883 031; ER10-2884 031; ER10-2885 031.
    Applicants: Alabama Power Company, Southern Power Company,
Mississippi Power Company, Georgia Power Company, Gulf Power Company,
Oleander Power Project, Limited Partnership, Southern Company--Florida
LLC, Mankato Energy Center, LLC.
    Description: Updated Market Power Analysis for the Southeast Region
of Alabama Power Company, et al.
    Filed Date: 6/29/17.
    Accession Number: 20170629-5243.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER10-3066-002; ER10-2309 003; ER10-3058 002; ER10-
3059 002; ER10-3065 002.
    Applicants: Edgewood Energy, LLC, Elwood Energy, LLC, Equus Power
I, L.P., Pinelawn Power, LLC, Shoreham Energy, LLC.
    Description: Triennial Market Power Update for the Northeast Region
of J-POWER North America Holdings Co., Ltd. Affiliates.
    Filed Date: 6/29/17.
    Accession Number: 20170629-5250.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER11-3576-014; ER11-3401 013.
    Applicants: Golden Spread Electric Cooperative, Inc., Golden Spread
Panhandle Wind Ranch, LLC.
    Description: Notice of Non-material Change in Status of Golden
Spread Electric Cooperative, Inc.
    Filed Date: 6/29/17.
    Accession Number: 20170629-5248.
    Comments Due: 5 p.m. ET 7/20/17.

    Docket Numbers: ER14-2327-002; ER14-2328 002; ER14-2329 002; ER14-
2330 002.
    Applicants: Entergy Services, Inc., Entergy Nuclear Generation
Company, Entergy Nuclear Indian Point 2, LLC, Entergy Nuclear Indian
Point 3, LLC, Entergy Nuclear Power Marketing, LLC.
    Description: Triennial Market Power Update for the Northeast Region
of the Entergy Northeast MBR Utilities.
    Filed Date: 6/29/17.
    Accession Number: 20170629-5239.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER15-1308-004; ER11-2765 002; ER12-1739 002; ER12-
2310 005.
    Applicants: Kingfisher Wind, LLC, Bethel Wind Energy LLC, Elk Wind
Energy LLC, Zephyr Wind, LLC.
    Description: Notice of Non-Material Change in Status of the
BlackRock MBR Affiliates.
    Filed Date: 6/29/17.
    Accession Number: 20170629-5249.
    Comments Due: 5 p.m. ET 7/20/17.

    Docket Numbers: ER17-1957-000.
    Applicants: Black Hills Colorado IPP, LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff to be effective 8/28/2017.
    Filed Date: 6/29/17.
    Accession Number: 20170629-5193.
    Comments Due: 5 p.m. ET 7/20/17.

    Docket Numbers: ER17-1958-000.
    Applicants: New York State Electric & Gas Corporation.
    Description: Sec.  205(d) Rate Filing: NYSEG-NYPA Attachment C--O&M
Annual Update to be effective 9/1/2017.
    Filed Date: 6/29/17.
    Accession Number: 20170629-5194.
    Comments Due: 5 p.m. ET 7/20/17.

    Docket Numbers: ER17-1959-000.
    Applicants: Tampa Electric Company.
    Description: Sec.  205(d) Rate Filing: Section 205 Requirements
Depreciation Rates 2017 Filing--Solar to be effective 1/1/2016.
    Filed Date: 6/29/17.
    Accession Number: 20170629-5212.
    Comments Due: 5 p.m. ET 7/20/17.

    Docket Numbers: ER17-1960-000.
    Applicants: Helix Ravenswood, LLC.
    Description: Sec.  205(d) Rate Filing: Notice of Succession and
Revisions to Spot Black Start service Rate Schedule to be effective 6/
2/2017.
    Filed Date: 6/29/17.
    Accession Number: 20170629-5220.
    Comments Due: 5 p.m. ET 7/20/17.

    Docket Numbers: ER17-1961-000.
    Applicants: Kendall Green Energy LLC.
    Description: Market-Based Triennial Review Filing: Northeast
Triennial & Tariff Revisions to be effective 6/30/2017.
    Filed Date: 6/29/17.
    Accession Number: 20170629-5221.
    Comments Due: 5 p.m. ET 8/28/17.

    Docket Numbers: ER17-1962-000.
    Applicants: New York State Electric & Gas Corporation.
    Description: Sec.  205(d) Rate Filing: Rate Schedule FERC No. 87
Supplement to be effective 9/1/2017.
    Filed Date: 6/29/17.
    Accession Number: 20170629-5228.
    Comments Due: 5 p.m. ET 7/20/17.

    Take notice that the Commission received the following qualifying
facility filings:

    Docket Numbers: QF17-1140-000.
    Applicants: UE00211NJ, LLC.
    Description: Form 556 of UE00211NJ, LLC under QF17-1140.
    Filed Date: 6/29/17.
    Accession Number: 20170629-5156.
    Comments Due: None Applicable.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 30, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-14329 Filed 7-7-17; 8:45 am]
 BILLING CODE 6717-01-P


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

General Comment:I started smoking cigarettes at an early age around 15 and it became a bad habit for me, at first I really hated the smell, and the coughing it caused me, but later I got used to it and it didn't bother me as much, but it would bother everyone else around me, and I felt bad but there wasn't anything that could make me quit. Finally I found out about vaping, and it really changed my life it was the only method that made me quit. After I started vaping, I actually couldn't stand being around cigarettes smell. I feel healthier and more active now. The FDA shouldn't be classifying this as tobacco, because it doesn't have any of it at all. I encourage every cigarette smoker to vape now, because I know it's making a difference. A 75 day comment period is insufficient time for the vaping industry and the wider vaping community to comment on the proposed deeming regulations. I would respectfully request that the period for comment be extended to 180 days.


[Federal Register Volume 84, Number 33 (Tuesday, February 19, 2019)]
[Notices]
[Pages 4899-4900]
[FR Doc No: 2019-02660]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2018-0057]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt eight individuals from
the requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs) that interstate commercial motor vehicle (CMV) drivers have
``no established medical history or clinical diagnosis of epilepsy or
any other condition which is likely to cause loss of consciousness or
any loss of ability to control a CMV.'' The exemptions enable these
individuals who have had one or more seizures and are taking anti-
seizure medication to operate CMVs in interstate commerce.

DATES: The exemptions were applicable on January 9, 2019. The
exemptions expire on January 9, 2021.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2018-0057, in the keyword box, and
click ``Search.'' Next, click the ``Open Docket Folder'' button and
choose the document to review. If you do not have access to the
internet, you may view the docket online by visiting the Docket
Management Facility in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9
a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On November 27, 2018, FMCSA published a notice announcing receipt
of applications from eight individuals requesting an exemption from the
epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8) and
requested comments from the public (83 FR 60940). The public comment
period ended on December 27, 2018, and no comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting exemptions to these individuals would achieve
a level of safety equivalent to, or greater than, the level that would
be achieved by complying with the current regulation 49 CFR
391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391--MEDICAL
ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8), paragraphs
3, 4, and 5.]
---------------------------------------------------------------------------

    \1\ See http://www.ecfr.gov/cgi-bin/text-idx?SID=e47b48a9ea42dd67d999246e23d97970&mc=true&node=pt49.5.391&rgn=div5#ap49.5.391_171.a and https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
for up to five years from the epilepsy and seizure disorder prohibition
in 49 CFR 391.41(b)(8) if the exemption is likely to achieve an
equivalent or greater level of safety than would be achieved without
the exemption. The exemption allows the applicants to operate CMVs in
interstate commerce. FMCSA grants exemptions from the FMCSRs for a two-
year period to align with the maximum duration of a driver's medical
certification.
    In reaching the decision to grant these exemption requests, FMCSA
considered the 2007 recommendations of the Agency's Medical Expert
Panel (MEP). The January 15, 2013, Federal Register notice (78 FR 3069)
provides the current MEP recommendations which is the criteria the
Agency uses to grant seizure exemptions.
    The Agency's decision regarding these exemption applications is
based on an individualized assessment of each applicant's medical
information, including the root cause of the respective seizure(s) and
medical information about the applicant's seizure history, the length
of time that has elapsed since the individual's last seizure, the
stability of each individual's treatment regimen and the duration of
time on or off of anti-seizure medication. In addition, the Agency
reviewed the treating clinician's medical opinion related to the
ability of the driver to safely operate a CMV with a history of seizure
and each applicant's driving record found in the Commercial Driver's
License Information System (CDLIS) for commercial driver's license
(CDL) holders, and interstate and intrastate inspections recorded in
the Motor Carrier Management Information System (MCMIS). For non-CDL
holders, the Agency reviewed the driving records from the State
Driver's Licensing Agency (SDLA). A summary of each applicant's seizure
history was discussed in the November 27, 2018, Federal Register notice
(83 FR 60940) and will not be repeated in this notice.
    These eight applicants have been seizure-free over a range of 34
years while taking anti-seizure medication and maintained a stable
medication treatment regimen for the last two years. In each case, the
applicant's treating physician verified his or her seizure history and
supports the ability to drive commercially.
    The Agency acknowledges the potential consequences of a driver
experiencing a seizure while operating a CMV. However, the Agency
believes the drivers granted this exemption have demonstrated that they
are unlikely to have a seizure and their medical condition does not
pose a risk to public safety.

    Consequently, FMCSA finds that in each case exempting these
applicants from the epilepsy and seizure disorder prohibition in 49 CFR
391.41(b)(8) is likely to achieve a level of safety equal to that
existing without the exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must remain seizure-free and maintain a stable treatment
during the two-year exemption period; (2) each driver must submit
annual reports from their treating physicians attesting to the
stability of treatment and that the driver has remained seizure-free;
(3) each driver must undergo an annual medical examination by a
certified Medical Examiner, as defined by 49 CFR 390.5; and (4) each
driver must provide a copy of the annual medical certification to the
employer for retention in the driver's qualification file, or keep a
copy of his/her driver's qualification file if he/she is self-employed.
The driver must also have a copy of the exemption when driving, for
presentation to a duly authorized Federal, State, or local enforcement
official.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the eight exemption applications,
FMCSA exempts the following drivers from the epilepsy and seizure
disorder prohibition, 49 CFR 391.41(b)(8), subject to the requirements
cited above:

Kevin L. Addington (PA)
Miodrag Djukanovic (OR)
Daniel R. Gast (KS)
David R. Johnston (MN)
Sheldon R. Martin (NY)
Brian L. McDaniel (MO)
Kevin D. Wiggins (KY)
Robert R. Woods, Jr. (CT)

    In accordance with 49 U.S.C. 31315(b)(1), each exemption will be
valid for two years from the effective date unless revoked earlier by
FMCSA. The exemption will be revoked if the following occurs: (1) The
person fails to comply with the terms and conditions of the exemption;
(2) the exemption has resulted in a lower level of safety than was
maintained prior to being granted; or (3) continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136 and 31315.

    Issued on: February 8, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-02660 Filed 2-15-19; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 83, Number 131 (Monday, July 9, 2018)]
[Rules and Regulations]
[Pages 31646-31648]
[FR Doc No: 2018-14504]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0270; Product Identifier 2017-NM-133-AD; Amendment
39-19324; AD 2018-14-04]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Airbus Model A330-200 Freighter, A330-200, A330-300, A340-200, A340-
300, A340-500, and A340-600 series airplanes. This AD was prompted by a
determination that a functional test to ensure that there is no
blockage of vent pipes was not done on the trim tank of certain
airplanes during production. This AD requires doing a trim tank
functional test, and corrective actions if necessary. We are issuing
this AD to address the unsafe condition on these products.

DATES: This AD is effective August 13, 2018.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of August 13,
2018.

ADDRESSES: For service information identified in this final rule,
contact Airbus SAS, Airworthiness Office--EAL, Rond-Point Emile
Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36
96; fax +33 5 61 93 45 80; email [email protected];
internet http://www.airbus.com. 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<PHONE_NUMBER>. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0270.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0270; 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 (phone: 800-647-
5527) is in the ADDRESSES section. Comments will be available in the AD
docket shortly after receipt.

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

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Airbus Model A330-
200 Freighter, A330-200, A330-300, A340-200, A340-300, A340-500, and
A340-600 series airplanes. The NPRM published in the Federal Register
on April 16, 2018 (83 FR 16245). The NPRM was prompted by a
determination that a functional test to ensure that there is no
blockage of vent pipes was not done on the trim tank of certain
airplanes during production. The NPRM proposed to require doing a trim
tank functional test, and corrective actions if necessary.
    We are issuing this AD to address blocked vent pipes, which, in
combination with a high level sensor failure, could lead to over-
pressurization of the trim tank during refueling or aft fuel transfer.
This condition could lead to trim tank rupture and consequent reduced
control of the airplane.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2017-0152, dated August 17, 2017 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for certain Airbus Model
A330-200 Freighter, A330-200, A330-300, A340-200, A340-300, A340-500,
and A340-600 series airplanes. The MCAI states:

    It was discovered that the production functional test to verify
the ``Tank Pressures during Refuel Overflow'' was not performed on
the Trim Tank (TT) of A330 and A340 aeroplanes up to MSN
[manufacturer serial number] 1711. This test ensures that there is
no blockage of the vent pipes.
    This condition, if not corrected, could lead, in combination
with a high level sensor failure, to an over-pressurisation of the
TT during refueling or during aft fuel transfer, possibly resulting
in a TT rupture and consequent reduced control of the aeroplane.
    To address this potential unsafe condition, Airbus published
Service Bulletin (SB) A330-28-3130, SB A340-28-4140 and SB A340-28-
5061, to provide functional test instructions.
    For the reasons described above, this [EASA] AD requires a one-
time functional test of the TT overflow and, depending on findings,
accomplishment of applicable corrective action(s).

    Corrective actions include a general visual inspection of the
aperture leading to the flame arrestors (NACA duct), a detailed
inspection of the flame arrestor, and blockage removal or repair of any
discrepant NACA duct.
    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0270.

Comments

    We gave the public the opportunity to participate in developing
this final rule. We have considered the comment received. The Air Line
Pilots Association, International (ALPA), indicated its support for the
NPRM.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this final rule as proposed, except for minor editorial changes. We
have 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

    Airbus has issued the following service information:
     Service Bulletin A330-28-3130, Revision 00, dated May 18,
2017.
     Service Bulletin A340-28-4140, Revision 00, dated May 18,
2017.
     Service Bulletin A340-28-5061, Revision 00, dated May 18,
2017.
    This service information describes procedures for doing a trim tank
overflow functional test, a general visual inspection of the aperture
leading to the flame arrestors (NACA duct), a detailed inspection of
the flame arrestor, and blockage removal or repair of discrepant NACA
ducts. These documents are distinct since they apply to different
airplane models. This service information is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 97 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Functional test.......................  16 work-hours x $85 per               $0          $1,360        $131,920
                                         hour = $1,360.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary inspections
that would be required based on the results of the functional test. We
have no way of determining the number of aircraft that might need these
inspections:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Inspections...................................  2 work-hours x $85 per hour =                 $0            $170
                                                 $170.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would allow us to provide
cost estimates for the blockage removal or repair of a discrepant NACA
duct specified in this AD.

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.
    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

    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) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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 adding the following new airworthiness
directive (AD):

2018-14-04 Airbus: Amendment 39-19324; Docket No. FAA-2018-0270;
Product Identifier 2017-NM-133-AD.

(a) Effective Date

    This AD is effective August 13, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the airplanes identified in paragraphs (c)(1)
through (c)(7) of this AD, certificated in any category,
manufacturer serial numbers 1 through 1711 inclusive.
    (1) Airbus Model A330-223F and -243F airplanes.
    (2) Airbus Model A330-201, -202, -203, -223, and -243 airplanes.
    (3) Airbus Model A330-301, -302, -303, -321, -322, -323, -341, -
342, and -343 airplanes.
    (4) Airbus Model A340-211, -212, -213 airplanes.
    (5) Airbus Model A340-311, -312, and -313 airplanes.
    (6) Airbus Model A340-541 airplanes.
    (7) Airbus Model A340-642 airplanes.

(d) Subject

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

(e) Reason

    This AD was prompted by a determination that a functional test
to ensure that there is no blockage of vent pipes was not done on
the trim tank of certain airplanes during production. We are issuing
this AD to address blocked vent pipes, which, in combination with a
high level sensor failure, could lead to over-pressurization of the
trim tank during refueling or aft fuel transfer. This condition
could lead to trim tank rupture and consequent reduced control of
the airplane.

(f) Compliance

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

(g) Functional Test

    Within 42 months after the effective date of this AD, do a trim
tank overflow functional test in accordance with the Accomplishment
Instructions of the service information specified in paragraphs
(g)(1) through (g)(3), as applicable.
    (1) Airbus Service Bulletin A330-28-3130, Revision 00, dated May
18, 2017.
    (2) Airbus Service Bulletin A340-28-4140, Revision 00, dated May
18, 2017.
    (3) Airbus Service Bulletin A340-28-5061, Revision 00, dated May
18, 2017.

(h) Corrective Actions

    (1) If, during the functional test required by paragraph (g) of
this AD, the trim tank maximum allowable pressure is exceeded:
Before further flight, contact the Manager, International Section,
Transport Standards Branch, FAA; or the European Aviation Safety
Agency (EASA); or Airbus's EASA Design Organization Approval (DOA)
to obtain instructions for corrective actions, and within the
compliance time indicated in those instructions accomplish the
corrective actions accordingly.
    (2) If, during the functional test required by paragraph (g) of
this AD, the trim surge tank maximum allowable pressure is exceeded:
Before further flight, do a general visual inspection of the
aperture leading to the flame arrestors (NACA duct) and do a
detailed inspection of the flame arrestor in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A330-28-3130,
Revision 00, dated May 18, 2017; Airbus Service Bulletin A340-28-
4140, Revision 00, dated May 18, 2017; or Airbus Service Bulletin
A340-28-5061, Revision 00, dated May 18, 2017; as applicable.
    (3) If, during any inspection required by paragraph (h)(2) of
this AD, any discrepancy (blockage or damage of the NACA duct) is
found: Before further flight, accomplish the applicable corrective
actions in accordance with the Accomplishment Instructions of Airbus
Service Bulletin A330-28-3130, Revision 00, dated May 18, 2017;
Airbus Service Bulletin A340-28-4140, Revision 00, dated May 18,
2017; or Airbus Service Bulletin A340-28-5061, Revision 00, dated
May 18, 2017; as applicable.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (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 (j)(2) of this AD. Information
may be emailed to: [email protected]. 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: 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 EASA; or Airbus's EASA
DOA. If approved by the DOA, the approval must include the DOA-
authorized signature.
    (3) Required for Compliance (RC): If any service information
contains procedures or tests that are identified as RC, those
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2017-0152, dated August 17, 2017, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2018-0270.
    (2) For more information about this AD, contact Vladimir
Ulyanov, Aerospace Engineer, International Section, Transport
Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Airbus Service Bulletin A330-28-3130, Revision 00, dated May
18, 2017.
    (ii) Airbus Service Bulletin A340-28-4140, Revision 00, dated
May 18, 2017.
    (iii) Airbus Service Bulletin A340-28-5061, Revision 00, dated
May 18, 2017.
    (3) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAL, Rond-Point Emile Dewoitine
No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax
+33 5 61 93 45 80; email [email protected];
internet http://www.airbus.com.
    (4) 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.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on June 26, 2018.
Jeffrey E. Duven,
 Director, System Oversight Division, Aircraft Certification Service.
[FR Doc. 2018-14504 Filed 7-6-18; 8:45 am]
 BILLING CODE 4910-13-P