[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Proposed Rules]
[Pages 86312-86314]
[FR Doc No: 2023-27295]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R10-OAR-2023-0224; FRL-10859-01-R10]

Approval and Promulgation of State Plans for Designated
Facilities and Pollutants; Spokane Regional Clean Air Agency; Control
of Emissions From Existing Large Municipal Waste Combustors

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
partially approve and partially disapprove a Clean Air Act (CAA) State
Plan submitted by the Spokane Regional Clean Air Agency (SRCAA). This
State Plan establishes emission limits for existing large municipal
waste combustors (MWC) and provides for the implementation and
enforcement of these limits. SRCAA submitted this State Plan to fulfill
its requirements under the CAA in response to the EPA's promulgation of
Emissions Guidelines and Compliance Times for Large MWC Constructed on
or before September 20, 1994 (Emission Guidelines). The EPA is
partially approving the State Plan because it meets the requirements of
the Emission Guidelines for existing large MWC known to operate in
Spokane County, Washington. The EPA is partially disapproving the State
Plan because it omits requirements for fluidized bed combustors and air
curtain incinerators, which are required elements of a State Plan.

DATES: Written comments must be received on or before January 12, 2024.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2023-0224 at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be confidential business information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For additional submission methods, please contact
the person identified in the FOR FURTHER INFORMATION CONTACT section.
For the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Bryan Holtrop (he/him), U.S. EPA,
Region 10. He can be reached by phone at<PHONE_NUMBER> or by email at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 111(d) of the CAA requires the EPA to establish a procedure
for a state to submit a plan to the EPA that establishes standards of
performance for any air pollutant: (1) for which air quality criteria
have not been issued or which is not included on a list published under
CAA section 108 or emitted from a source category which is regulated
under CAA section 112 and (2) to which a standard of performance under
CAA section 111 would apply if such existing source were a new source.
Section 129(b)(2) of the CAA requires that after the EPA promulgates
guidelines for a category of solid waste incineration units, each state
in which units in the category are operating shall submit to the EPA a
plan to implement and enforce the guidelines with respect to such
units. Such plans shall be at least as protective as the guidelines
promulgated by the EPA. The EPA established requirements for State Plan
submittals in the Code of Federal Regulations (CFR) at 40 CFR part 60,
subpart B. State submittals under CAA sections 111(d) and 129 must be
consistent with the relevant emission guidelines, in this instance 40
CFR part 60, subpart Cb, and the requirements of 40 CFR part 60,
subpart B.
    On May 10, 2006, the EPA revised the regulations established for
Emissions Guidelines and Compliance Times for Large MWC That Are
Constructed on or before September 20, 1994, in 40 CFR part 60, subpart
Cb (71 FR 27324). This action was taken under sections 111(d) and 129
of the CAA.
    On July 18, 2022, SRCAA submitted to the EPA a section 111(d)/129
plan for existing large MWC. The submitted section plan was in response
to the May 10, 2006, promulgation of Federal emission guidelines
requirements for large MWC, 40 CFR part 60, subpart Cb (71 FR 27336).

II. Summary of the Plan and EPA Analysis

    The EPA has reviewed the SRCAA section 111(d)/129 plan submittal in
the context of the requirements of 40 CFR part 60, subparts B and Cb.
In this action, the EPA is proposing to determine that SRCAA's section
111(d)/129 plan meets the cited Federal requirements, except with
regard to fluidized bed combustors and air curtain incinerators. On
April 5 2007, SRCAA amended Regulation I, Article VI, Section 6.17 to
incorporate the EPA's revisions to the Emission Guidelines for large
MWC and made administrative formatting updates, adopted on July 9,
2020. The primary mechanism used by SRCAA to implement the Emission
Guidelines for existing large MWC under state jurisdiction is through
incorporation by reference of 40 CFR part 60, subpart Cb requirements
into Regulation 1, Article VI, Section 6.17. The changes SRCAA made to
the language in the Emission Guidelines were made to convert the
language in the Emission Guidelines to enforceable requirements.
Because SRCAA reported that there are only two units at a single
facility subject to the proposed State Plan--both of which utilize the
mass burn waterwall combustor technology--SRCAA did not include
requirements in the Emission Guidelines that apply to fluidized bed
combustors (40 CFR 60.33b(d)(3)) or air curtain incinerators (40 CFR
60.37b). In each case, the Emission Guidelines clearly state that ``for
approval, a State Plan shall include . . .'' the specified
requirements. The EPA has no discretion to fully approve a State Plan
that omits a required element. For this reason, the EPA is proposing to
partially disapprove SRCAA's State Plan insofar as it does not address
regulatory requirements applicable to fluidized bed combustors and air
curtain incinerators.
    These regulations will be applicable to existing large MWC in
Spokane County, Washington upon the EPA's approval of the plan by final
rulemaking, except that fluidized bed combustors and air curtain
incinerators that are designated facilities under the Emission
Guidelines per 40 CFR 60.32b shall be subject to the Federal Plan
Requirements for Large Municipal Waste Combustors Constructed on or
before September 20, 1994 (40 CFR part 62, subpart FFF). A more
detailed explanation of the rationale behind this proposed approval is
available in the Technical Support Document (TSD) that may be found in
the docket for this action.

III. Proposed Action

    The EPA is proposing to partially approve and partially disapprove
the SRCAA section 111(d)/129 plan for large MWC submitted pursuant to
40 CFR part 60, subpart Cb. Therefore, the EPA is proposing to amend 40
CFR part 62, subpart WW to reflect this action.
    This partial approval and partial disapproval is based on the
rationale previously discussed in this document and in further detail
in the TSD that may be found in the docket for this action. The scope
of the proposed partial approval of the section 111(d)/129 plan is
limited to the provisions of 40 CFR part 60, subpart Cb that apply to
existing large MWC in Spokane County that are not fluidized bed
combustors or air curtain incinerators. The EPA Administrator continues
to retain the authorities identified in 40 CFR 60.30b(b) as authorities
retained by the Administrator.

IV. Incorporation by Reference

    In this document, the EPA is proposing to include regulatory text
that incorporates by reference the State Plan. In accordance with
requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference SRCAA Regulation I, Article VI, Section 6.17, which became
effective within the SRCAA's jurisdiction on July 7, 2022. The
regulatory provisions of this section of the SRCAA rule incorporate all
the CAA 111(d)/129 State Plan elements required by the EG for existing
large MWC promulgated at 40 CFR part 60, subpart Cb. The emissions
standards and compliance times established within the SRCAA State Plan
are at least as stringent as those required by the EG for existing
large MWC subject to subpart Cb. The EPA has made, and will continue to
make, these materials generally available through the docket for this
action, EPA-R10-OAR-2023-0224, at https://www.regulations.gov and at
EPA Region 10 Office (please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section of this preamble for more
information).

V. Statutory and Executive Order Reviews

    In reviewing State Plan submissions, the EPA's role is to approve
state choices, provided that they meet the criteria of the CAA.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11,
2023);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001); and
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA.
    Executive Order 12898 (Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations, 59 FR 7629,
February 16, 1994) directs Federal agencies to identify and address
``disproportionately high and adverse human health or environmental
effects'' of their actions on minority populations and low-income
populations to the greatest extent practicable and permitted by law.
The EPA defines environmental justice (EJ) as ``the fair treatment and
meaningful involvement of all people regardless of race, color,
national origin, or income with respect to the development,
implementation, and enforcement of environmental laws, regulations, and
policies.'' The EPA further defines the term fair treatment to mean
that ``no group of people should bear a disproportionate burden of
environmental harms and risks, including those resulting from the
negative environmental consequences of industrial, governmental, and
commercial operations or programs and policies.''
    The air agency did not evaluate environmental justice
considerations as part of its submittal; the Clean Air Act and
applicable implementing regulations neither prohibit nor require such
an evaluation. The EPA did not

perform an EJ analysis and did not consider EJ in this action. Due to
the nature of this action, it is expected to have a neutral to positive
impact on the air quality of the affected area. Consideration of EJ is
not required as part of this action, and there is no information in the
record inconsistent with the stated goal of Executive Order 12898 of
achieving environmental justice for people of color, low-income
populations, and Indigenous peoples.
    In addition, this proposed rulemaking would not apply on any Indian
reservation land or in any other area in Washington where the EPA or an
Indian Tribe has demonstrated that a Tribe has jurisdiction. In those
areas of Indian country, the proposed rule would not have Tribal
implications as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000).

List of Subjects in 40 CFR Part 62

    Environmental protection, Administrative practice and procedure,
Air pollution control, Hazardous substances, Incorporation by
reference, Intergovernmental relations, Reporting and recordkeeping
requirements, Waste treatment and disposal.

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

    Dated: December 7, 2023.
Casey Sixkiller,
Regional Administrator, Region 10.
[FR Doc. 2023-27295 Filed 12-12-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Proposed Rules]
[Pages 28895-28896]
[FR Doc No: 2020-10246]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0483; Product Identifier 2016-SW-066-AD]
RIN 2120-AA64

Airworthiness Directives; MD Helicopters Inc. (MDHI), Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain MD Helicopters Inc. (MDHI), Model 369A, 369D, 369E, 369FF,
369H, 369HE, 369HM, 369HS, 500N, and 600N helicopters. This proposed AD
would require tap inspecting each main rotor (MR) blade leading edge
abrasion strip and is prompted by reports of abrasion strips departing
the MR blade in-flight. The proposed actions are intended to prevent an
unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by July 13,
2020.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to https://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address 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 https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0483; 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 proposed AD, any comments received, and other information. The
street address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.
    For service information identified in this proposed rule, contact
Helicopter Technology Company, LLC, address 12902 South Broadway, Los
Angeles, CA 90061; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>or at http://www.helicoptertech.com. You
may view the referenced service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321,
Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Payman Soltani, Aviation Safety
Engineer, Los Angeles ACO Branch, FAA, 3960 Paramount Blvd., Lakewood,
California 90712; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to participate in this rulemaking by submitting
written comments, data, or views. The FAA also invites comments
relating to the economic, environmental, energy, or federalism impacts
that might result from adopting the proposals in this document. The
most helpful comments reference a specific portion of the proposal,
explain the reason for any recommended change, and include supporting
data. To ensure the docket does not contain duplicate comments,
commenters should send only one copy of written comments, or if
comments are filed electronically, commenters should submit only one
time.
    The FAA will file in the docket all comments received, as well as a
report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal,
the FAA will consider all comments received on or before the closing
date for comments. The FAA will consider comments filed after the
comment period has closed if it is possible to do so without incurring
expense or delay. The FAA may change this proposal in light of the
comments received.

Discussion

    The FAA proposes to adopt a new AD for MDHI Model 369A, 369D, 369E,
369FF, 369H, 369HE, 369HM, 369HS, 500N, and 600N helicopters with an MR
blade part number (P/N) 500P2100-105, P/N 500P2100-305, P/N 500P2300-
505, P/N 369D21120-505, P/N 369D21121-505, or P/N 369D21123-505, with a
1.25-inch chord length nickel abrasion strip (abrasion strip)
manufactured or installed by Helicopter Technology Company (HTC) or
where the manufacturer of the abrasion strip is unknown. This proposed
AD would require tap inspecting the abrasion strip within 10 hours
time-in-service (TIS) and thereafter before the first flight of each
day until the abrasion strip has accumulated 700 hours TIS since
installation.
    This proposed AD is prompted by reports that leading edge abrasion
strips manufactured by HTC are departing the MR blades during flight.
An investigation determined that the abrasion strips were manufactured
from electroformed nickel, have a chord length of 1.25 inch, and are
delaminating from the MR blade before departing from the helicopter.
HTC has determined that a repetitive tap inspection of the abrasion
strips should be performed on all blades with abrasion strips that have
less than 700 hours TIS to detect any voids, including blistering,
bubbling, or lifting of the abrasion strip. Identical looking
electroformed nickel abrasion strips with a chord length of 1.25 inch
manufactured by other repair stations have not departed in flight and
therefore are not the subject of this proposed AD. If the manufacturer
of the installed abrasion strip is unknown, this proposed AD would
apply to the strip.

FAA's Determination

    The FAA is proposing this AD because the agency evaluated all known
relevant information and determined that an unsafe condition exists and
is likely to exist or develop on other helicopters of these same type
designs.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed HTC Mandatory Service Bulletin Notice No. 2100-
8R4, dated June 1, 2017, which specifies a daily tap inspection of the
MR blade abrasion strip to detect voids. If there are any voids, the SB
specifies repairing or replacing the MR blade, depending on the size,
quantity, and location of any damage.
    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.

Proposed AD Requirements

    This proposed AD would require, within 10 hours TIS and thereafter
before the first flight of each day until the abrasion strip reaches
700 hours TIS, tap inspecting the leading edge abrasion strip for a
void. If there is a void within 0.5 inch (12.7 mm) of the edge of the
abrasion strip, the proposed AD would require replacing the blade with
an airworthy blade before further flight. If there is a void that is
not within 0.5 inch (12.7 mm) from the edge of the abrasion strip and
is larger than 0.5 square inch (322.6 square mm) or if there is more
than one void of any size, the proposed AD would require replacing the
blade with an airworthy blade before further flight.

Costs of Compliance

    The FAA estimates that this proposed AD would affect 50 helicopters
of U.S. Registry.
    The FAA estimates that operators may incur the following costs in
order to comply with this AD. At an average labor rate of $85 per hour,
tap-testing the MR blades will require about 0.25 work-hour, for a cost
per helicopter of $22 per inspection cycle.
    If required, replacing an MR blade would require 1 work-hour, and
required parts would cost up to $24,130, for a cost per helicopter of
$24,215.
    According to HTC's service information some of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. The FAA does not control warranty
coverage by HTC. Accordingly, the FAA has included all costs in our
cost estimate.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

MD Helicopters Inc. (MDHI): Docket No. FAA-2020-0483; Product
Identifier 2016-SW-066-AD.

(a) Applicability

    This AD applies to MD Helicopters Inc. (MDHI), Model 369A, 369D,
369E, 369FF, 369H, 369HE, 369HM, 369HS, 500N, and 600N helicopters,
certificated in any category, with a main rotor (MR) blade part
number (P/N) 500P2100-105, P/N 500P2100-305, P/N 500P2300-505, P/N
369D21120-505, P/N 369D21121-505, or P/N 369D21123-505 with a 1.25
inch chord length nickel abrasion strip (abrasion strip)
manufactured or installed by Helicopter Technology Company (HTC) or
where the manufacturer of the abrasion strip is unknown. This AD
does not apply if the abrasion strip has accumulated 700 or more
hours time-in-service (TIS).

(b) Unsafe Condition

    This AD defines the unsafe condition as failure of the bond
between the leading edge abrasion strip and an MR blade. This
condition could result in the abrasion strip departing the MR blade
in-flight, subsequent imbalance of the rotor system, and loss of
control of the helicopter.

(c) Comments Due Date

    The FAA must receive comments by July 13, 2020.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 10 hours TIS and thereafter before the first flight of
each day, tap inspect each MR blade leading edge abrasion strip for
a void in accordance with Part 1--Inspection, paragraphs 2 through
4, of HTC Mandatory Service Bulletin Notice No. 2100-8R4, dated June
1, 2017.
    (1) If there is a void within 0.5 inch (12.7 mm) of the edge of
the abrasion strip, before further flight, replace the MR blade.
    (2) If there is a void larger than 0.5 square inch (322.6 square
mm) or if there is more than one void of any size, before further
flight, replace the MR blade.

(f) Alternative Methods of Compliance (AMOC)

    (1) The Manager, Los Angeles ACO Branch, FAA, may approve AMOCs
for this AD. Send your proposal to: Payman Soltani, Aviation Safety
Engineer, Los Angeles ACO Branch, FAA, 3960 Paramount Blvd.,
Lakewood, California 90712; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, the FAA suggests
that you notify your principal inspector, or lacking a principal
inspector, the manager of the local flight standards district office
or certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

 (g) Subject

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

    Issued on May 8, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-10246 Filed 5-13-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Rules and Regulations]
[Pages 8388-8389]
[FR Doc No: 2020-02448]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-0678; Airspace Docket No. 18-AWP-27]
RIN 2120-AA66

Amendment of Class D and Class E Airspace; Concord, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends the Class D airspace and establishes Class
E airspace extending upward from 700 feet above the surface of the
earth at Buchanan Field, Concord, CA. This action also removes the
Concord VOR/DME and the city listed before the airport name in the
legal description header information.

DATES: Effective 0901 UTC, May 21, 2020. 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 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11D, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov//air_traffic/publications/. For further information, you
can contact the Airspace Policy Group, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11D at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Matthew Van Der Wal, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S. 216th Street, Des Moines, WA 98198; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend Class D and establish Class E airspace at Buchanan
Field, Concord, CA, to ensure the safety and management of Instrument
Flight Rules (IFR) operations at the airport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (84 FR 56390; October 22, 2019) for Docket No. FAA-2019-0678
to amend Class D and Class E airspace at Buchanan Field, Concord, CA.
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. Seven
comments were received.
    Three comments contained only the Docket number, the airspace
docket number and the FAA's RIN number with no additional text or
comment.
    Two comments questioned why the airspace is being established,
since the San Francisco Sectional already appears to contain the
proposed airspace within an existing Class E airspace area extending
upward from 700 feet above the surface. This new airspace area is being
established for Buchanan Field to ensure the airport has independent
Class E airspace to contain arriving IFR aircraft when descending below
1,500 feet above the surface. Additionally, one commenter stated that
they could not find the proposed Class E area in FAA Order 7400.11D.
This action establishes the Class E airspace for the airport and the
airspace will be published in the next iteration of FAA Order 7400.11
which will be effective September 15, 2020.
    One comment asked how this change would affect local pilot's
knowledge of the local area. This change will be charted on subsequent
editions of the San Francisco Sectional. This respondent also asked
about ADSB equipage and access to airports in the area, below the SFO
Class B veil. This airspace action does not impact the equipment
requirements for aircraft operations within a Class B veil.
    One comment discussed IFR operations and airspace but did not
provide a specific concern or support for the proposal.
    Class D and Class E5 airspace designations are published in
paragraphs 5000 and 6005, respectively,

of FAA Order 7400.11D, dated August 8, 2019, and effective September
15, 2019, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designation listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11D, Airspace Designations and
Reporting Points, dated August 8, 2019, and effective September 15,
2019. FAA Order 7400.11D is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11D lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR)
part 71 modifies Class D airspace at Buchanan Field extending upward
from the surface to and including 2,500 feet MSL within a 2.6-mile
radius of the airport from the 205[deg] bearing from the airport
clockwise to the 314[deg] bearing, thence extending to a 4.1-mile
radius of airport from the 314[deg] bearing from the airport clockwise
to the 205[deg] bearing of Buchanan Field. This Class D airspace area
is effective during the specific dates and times established in advance
by a Notice to Airmen. The effective date and time will thereafter be
continuously published in the Chart Supplement.
    Additionally, this action establishes Class E5 airspace extending
upward from 700 feet above the surface within a 4.1-mile radius of
Buchanan Field and within 2.5 miles each side of the 009[deg] bearing
from the airport extending from the 4.1-mile radius to 11 miles north
of the airport, and within 2.5 miles each side of the 023[deg] bearing
from the airport extending from the 4.1-mile radius to 11 miles
northeast of Buchanan Field.
    Further, this action removes the Concord VOR/DME and the associated
extensions from the legal description to simplify how the airspace is
described.
    Lastly, this action removes the city listed before the airport name
in the legal description header information to comply with airspace
policy guidance.
    Class D and Class E5 airspace designations are published in
paragraphs 5000, and 6005, respectively, of FAA Order 7400.11D, dated
August 8, 2019, and effective September 15, 2019, which is incorporated
by reference in 14 CFR 71.1. The Class D and Class E airspace
designations listed in this document will be published subsequently in
the Order. FAA Order 7400.11, Airspace Designations and Reporting
Points, is published yearly and effective on September 15.

Regulatory Notices and Analyses

    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, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    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 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
 2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.11D, Airspace Designations and Reporting Points, dated August 8,
2019, and effective September 15, 2019, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

AWP CA D Concord, CA

Buchanan Field, CA
    (Lat. 37[deg]59'23'' N, long. 122[deg]03'25'' W)

    That airspace extending upward from the surface to and including
2,500 feet MSL within a 2.6-mile radius of the airport from the
205[deg] bearing from the airport clockwise to the 314[deg] bearing,
thence extending to a 4.1-mile radius of the airport from the
314[deg] bearing clockwise to the 205[deg] bearing from Buchanan
Field. This Class D airspace area is effective during the specific
dates and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Chart Supplement.

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

* * * * *

AWP CA E5 Concord, CA

Buchanan Field, CA
    (Lat. 37[deg]59'23'' N, long. 122[deg]03'25'' W)

    That airspace extending upward from 700 feet above the surface
within a 4.1-mile radius of Buchanan Field and within 2.5 miles each
side of the 009[deg] bearing from the airport extending from the
4.1-mile radius to 11 miles north of the airport and within 2.5
miles each side of the 023[deg] bearing from the airport extending
from the 4.1-mile radius to 11 miles northeast of Buchanan Field.

    Issued in Seattle, Washington, on February 3, 2020.
Byron Chew,
Group Manager, Western Service Center, Operations Support Group.
[FR Doc. 2020-02448 Filed 2-13-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 69 (Monday, April 11, 2022)]
[Notices]
[Page 21246]
[FR Doc No: 2022-07624]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94609; File No. SR-IEX-2021-14]

Self-Regulatory Organizations; Investors Exchange LLC; Notice of
Withdrawal of a Proposed Rule Change To Amend Its Fee Schedule for
Market Data Fees

April 5, 2022.
    On November 1, 2021, Investors Exchange LLC (``IEX'') filed with
the Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 \1\ and Rule
19b-4 thereunder,\2\ a proposed rule change to amend its Fee Schedule
for Market Data Fees. The proposed rule change was immediately
effective upon filing with the Commission pursuant to Section
19(b)(3)(A) of the Act.\3\ The proposed rule change was published for
comment in the Federal Register on November 17, 2021.\4\ On December
30, 2021, the Commission temporarily suspended the proposed rule change
and instituted proceedings under Section 19(b)(2)(B) of the Act \5\ to
determine whether to approve or disapprove the proposed rule change.\6\
On April 1, 2022, IEX withdrew the proposed rule change (SR-IEX-2021-
14).
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A). A proposed rule change may take
effect upon filing with the Commission if it is designated by the
exchange as ``establishing or changing a due, fee, or other charge
imposed by the self-regulatory organization on any person, whether
or not the person is a member of the self-regulatory organization.''
15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ See Securities Exchange Act Release No. 93557 (November 10,
2021), 86 FR 64268 (November 17, 2021).
    \5\ 15 U.S.C. 78s(b)(2)(B).
    \6\ See Securities Exchange Act Release No. 93883 (December 30,
2021), 87 FR 523 (January 5, 2022).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-07624 Filed 4-8-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Pages 79874-79875]
[FR Doc No: 2015-32129]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IN16-2-000]

ETRACOM LLC; Michael Rosenberg; Notice of Designation of
Commission Staff as Non-Decisional

December 16, 2015.
    With respect to an order issued by the Commission on December 16,
2015 in the above-captioned docket, with the exceptions noted below,
the staff of the Office of Enforcement are designated as non-decisional
in deliberations by the Commission in this docket.\1\ Accordingly,
pursuant to 18 CFR 385.2202 (2015), they will not serve as advisors to
the Commission or take part in the Commission's review of any offer of
settlement. Likewise, as non-decisional staff, pursuant to 18 CFR
385.2201 (2015), they are prohibited from communicating with advisory
staff concerning any deliberations in this docket.
---------------------------------------------------------------------------

    \1\ ETRACOM LLC and Michael Rosenberg, 153 FERC ] 61,314 (2015).
---------------------------------------------------------------------------

    Exceptions to this designation as non-decisional are:

Larry Parkinson
Lee Ann Watson
Janel Burdick
Maria Brun
Sam Bonar
Gabriel Sterling
Carol Clayton
Wesley Heath
Seema Jain

Blair Hopkin

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-32129 Filed 12-22-15; 8:45 am]
BILLING CODE P


[Federal Register Volume 85, Number 144 (Monday, July 27, 2020)]
[Notices]
[Pages 45209-45210]
[FR Doc No: 2020-16189]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file

associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. In addition to
publishing the full text of this document in the Federal Register, the
Commission provides all interested persons an opportunity to view and/
or print the contents of this document via the internet through the
Commission's Home Page (http://ferc.gov) using the ``eLibrary'' link.
Enter the docket number excluding the last three digits in the docket
number field to access the document. At this time, the Commission has
suspended access to the Commission's Public Reference Room, due to the
proclamation declaring a National Emergency concerning the Novel
Coronavirus Disease (COVID-19), issued by the President on March 13,
2020. For assistance, contact the Federal Energy Regulatory Commission
at<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for
TTY, contact<PHONE_NUMBER>.

------------------------------------------------------------------------
                                                        Presenter or
            Docket Nos.                File date          requester
------------------------------------------------------------------------
Prohibited:
    1. EL20-42-000................       7-13-2020  Mass Mailings.\1\
    2. EL20-42-000................       7-14-2020  Mass Mailings.\2\
    3. EL20-42-000................       7-14-2020  Mass Mailings.\3\
    4. EL19-58-000, EL17-32-000,         7-15-2020  FERC Staff.\4\
     EL17-36-000.
    5. EL20-42-000................       7-15-2020  Mass Mailings.\5\
    6. ER18-1314-006..............       7-17-2020  Customer First
                                                     Renewables.
Exempt:
    1. ER20-1926-000..............       7-15-2020  U.S. Senator John
                                                     Hoeven.
    2. P-14803-000, P-2082-000....       7-16-2020  U.S. Representative
                                                     Doug LaMalfa.
    3. CP17-458-000...............       7-21-2020  U.S. Representative
                                                     Tom Cole.
------------------------------------------------------------------------
\1\ Emailed comments of Stephen Schmeiser and 66 other individuals.
\2\ Emailed comments of Martha Spencer and 81 other individuals.
\3\ Emailed comments of Jean Su on behalf of 450 groups.
\4\ Email and memorandum regarding the 4/24/2020 communication with Jay
  Apt.
\5\ Emailed comments of Ed Manning and 170 other individuals.

    Dated: July 21, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-16189 Filed 7-24-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: May 13, 2009 (Volume 74, Number 91)]
[Rules and Regulations]
[Page 22460-22464]
[DOCID:fr13my09-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0164; FRL-8412-9]

Candida oleophila Strain O; Exemption from the Requirement of a
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the microbial pesticide, Candida
oleophila Strain O, on apples and pears when applied/used as a post-
harvest biofungicide. BioNext sprl (in care of SynTech Global, LLC)
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 Candida oleophila Strain O.

DATES: This regulation is effective May 13, 2009. Objections and
requests for hearings must be received on or before July 13, 2009, 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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0164. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Jeannine Kausch, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 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 person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's e-CFR site at http://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. 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-2008-0164 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before July 13, 2009.
    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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2008-0164, by one of the following methods.

     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of March 28, 2008 (73 FR 16673) (FRL-8355-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 7F7310) by BioNext sprl, Passage des deportes, 2, B-5030
Gembloux, Belgium (in care of SynTech Global, LLC, P.O. Box 640,
Hockessin, DE 19707). The petition requested that 40 CFR part 180 be
amended by establishing an exemption from the requirement of a
tolerance for residues of Candida oleophila Strain O. This notice
included a summary of the petition prepared by the petitioner, BioNext
sprl (in care of SynTech Global, LLC). There were no comments received
in response to the notice of filing.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue....
'' Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency
consider ``available information concerning the cumulative effects of a
particular pesticide's residues '' and ``other substances that have a
common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
    Candida oleophila Strain O is a single-celled yeast in the phylum
Ascomycota, the class Ascomycetes, and the family Saccharomycetaceae.
Found naturally on plant tissues (fruits, flowers, and wood) and in
water, it was originally isolated from Golden Delicious apples and is
intended for use as an antagonist to control the fungal pathogens, grey
mold (Botrytis cinerea) and blue mold (Penicillium expansum), that
cause post-harvest decay on apples and pears. The mode of action for
Candida oleophila Strain O is primarily through competition for
nutrients and pre-colonization of plant wound sites. Submitted data
also suggest that production of beta-1,3-glucanases (i.e., hydrolytic
enzymes that can degrade fungal phytopathogen cell walls) may
contribute to its antagonistic activity. According to reported testing,
Candida oleophila Strain O does not grow above 33[deg]C, is sensitive
to ultraviolet light, and is dependent on a carbon source for growth.
Some species of Candida are reported as opportunistic pathogens to
humans and/or animals. Candida oleophila, however, is an environmental
microbe unable to grow at mammalian body temperatures and easily
distinguished from the Candida species reported as clinical isolates.
More importantly, no pathogenic effects or infections from Candida
oleophila Strain O were seen in the submitted infectivity studies
discussed below and there have been no clinical reports of Candida
oleophila infection even though various strains of this species
naturally occur on food commodities such as apples, olives,
strawberries, fermenting grapes, and tomatoes. Additional information
regarding Candida oleophila Strain O can be found in the Biopesticides
Registration Action Document (BRAD) on the Biopesticides and Pollution
Prevention Division (BPPD) website: http://www.epa.gov/pesticides/
biopesticides.
    Studies submitted to the Agency were issued Master Record
Identification (MRID) Numbers and reviewed by BPPD scientists. These
submissions were considered in light of the microbial pesticides data
requirements, which became final on December 26, 2007 (72 FR 61002).
The following summaries of the toxicological profile of Candida
oleophila Strain O are based on an Agency risk assessment memorandum
and related data evaluation records dated November 13, 2008.

A. Acute Oral Toxicity and Pathogenicity - Rat (Office of Prevention,
Pesticides, and Toxic Substances [OPPTS] Guideline 885.3050; MRID No.
473138-07)

    In an acute oral toxicity and pathogenicity study, groups of rats
were given a single oral dose of Candida oleophila Strain O at a dose
of 2.3-3.8 x 108 colony-forming units (CFU)/animal. The
animals were observed for a period of up to 22 days with interim
scheduled sacrifices on days 4, 8, and 15. There were no treatment-
related clinical signs, necropsy findings, or changes in body weight.
No test organisms were recovered from the gastrointestinal contents,
any organs, or blood of any animal or feces from treated animals
sacrificed on day 22. Based on the results of this study, Candida
oleophila Strain O does not appear to be toxic, infective, and/or
pathogenic in rats. This study was rated ``ACCEPTABLE'' for risk
assessment purposes.

B. Acute Subcutaneous Injection Toxicity and Pathogenicity - Rat (OPPTS
Guideline 885.3200; MRID No. 473138-08)

     In an acute subcutaneous injection toxicity and pathogenicity
study, groups of rats were injected subcutaneously with Candida
oleophila Strain O with a dose of 1.1-2.0 x 107 CFU/animal.
The animals were observed for up to 22 days. There were no treatment-
related clinical signs, necropsy findings, or changes in body weight.
No test

organisms were recovered from the gastrointestinal contents, organs,
blood, or the injection site of any animal. Based on the results of
this study, Candida oleophila Strain O does not appear to be toxic,
infective, and/or pathogenic in rats, when dosed at 1.1-2.0 x
107 CFU/animal. This study was rated ``ACCEPTABLE'' for risk
assessment purposes.

C. Acute Pulmonary Toxicity and Pathogenicity - Rat (OPPTS Guideline
885.3150; MRID No. 473138-09)

    In an acute pulmonary toxicity and pathogenicity study, groups of
rats were exposed by the intratracheal route to Candida oleophila
Strain O at a dose of 1.2-5.2 x 108 CFU/animal. The animals
were observed for up to 22 days. There were no test substance-related
clinical signs, necropsy findings, or changes in body weight. Test
organisms were recovered in the lungs from the treated males and
females sacrificed one hour post dosing with clearance by day 4. No
test organisms were recovered from the gastrointestinal contents,
organs, or blood of any animal or feces from treated animals sacrificed
on day 22. Based on these results, Candida oleophila Strain O does not
appear to be toxic, infective, and/or pathogenic to rats at 1.2-5.2 x
108 CFU/animal. This study was rated ``ACCEPTABLE'' for risk
assessment purposes.

D. Hypersensitivity Incidents (OPPTS Guideline 885.3400; MRID No.
473138-12)

    During a pilot-plant production trial using fermentation vessels
and involving large amounts of Candida oleophila Strain O, 3 of 6
workers (all on the same work team) not wearing personal protective
equipment (PPE) reported clinical symptoms of a respiratory reaction.
No adverse dermal effects have been reported by workers. Respiratory
and dermal sensitization to consumers is not anticipated, mainly due to
the extremely high exposure to Candida oleophila Strain O encountered
by workers during the fermentation process as opposed to the very low
exposure anticipated on treated fruit intended for human consumption.
Any future hypersensitivity reports must be reported per OPPTS
Guideline 885.3400.

E. Bacterial Reverse Mutation Test (OPPTS Guideline 870.5100; MRID No.
473138-13) and In Vitro Mammalian Cell Gene Mutation Test (OPPTS
Guideline 870.5300; MRID No. 473138-14)

    Two mutagenicity tests were submitted, reviewed, and indicated that
Candida oleophila Strain O did not have mutagenic potential. These
studies were rated ``SUPPLEMENTAL'' for the purposes of risk assessment
and they are not required studies for this active ingredient.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).

A. Dietary Exposure

    Dietary exposure to Candida oleophila Strain O is likely to occur,
mainly through food. However, the lack of acute oral toxicity/
pathogenicity, based on the toxicology test on rats presented in Unit
III., and the ubiquitous nature of the microbe on various food
commodities support the establishment of an exemption from the
requirement of a tolerance for Candida oleophila Strain O.
Additionally, under 40 CFR 180.1144, a similar active ingredient,
Candida oleophila isolate I-182, was assessed previously and granted an
exemption from the requirement of a tolerance when used as a post-
harvest biological fungicide in or on all raw agricultural commodities.
    1. Food. Candida oleophila Strain O is naturally present on apples
as it was originally isolated in 1991 from the surface of Golden
Delicious apples. Based on information submitted to the Agency,
population densities of white yeasts are estimated to reach 1.5 x
103 CFU/square centimeter (cm2) on harvested
apples, which includes the natural population of Candida oleophila.
Background levels of Candida oleophila Strain O on apples are expected
to be below 1.5 x 103 CFU/cm2. Post-harvest
treatment with Candida oleophila Strain O will probably lead to a
temporary increased level of this yeast on apples. The mode of action
of Candida oleophila Strain O is primarily based on competition for
nutrients; therefore, sufficient colonization of apple surfaces has to
be reached to ensure efficacy of the active ingredient. The recommended
application rate of Candida oleophila Strain O leads to an expected
residual Candida oleophila Strain O population of approximately 4 x
104 CFU/cm2 (105 CFU/apple). Standard
practices of washing, peeling, cooking, or processing fruits further
reduces residues of Candida oleophila Strain O and minimizes dietary
exposure. Actual dietary exposure is expected to be several orders of
magnitude lower than the dose used in the acute oral toxicity/
pathogenicity test referenced in Unit III., during which no toxic or
pathogenic effects were observed in rats. The Agency concludes that
there is a reasonable certainty that no harm will result from the
aggregate exposure to the residues of Candida oleophila Strain O in
food.
    2. Drinking water exposure. Exposure of humans to residues of
Candida oleophila Strain O in drinking water is unlikely. The proposed
use pattern, use sites, and application methods for Candida oleophila
Strain O (i.e., dip or drench application to apples and pears after
harvest and prior to storage) does not include direct application to
aquatic environments. In the unlikely event that Candida oleophila
Strain O was transferred to surface or ground water intended for
eventual human consumption, the microbe would not survive the
conditions water is subjected to in a drinking water treatment
facility, including flocculation, chlorination, pH adjustments, and/or
filtration. Even if oral exposure should occur through drinking water,
the Agency concludes that there is a reasonable certainty that no harm
will result from the exposure to the residues of Candida oleophila
Strain O in all the anticipated drinking water exposures because of the
lack of acute oral toxicity/pathogenicity to mammals and the ubiquitous
nature of the microbe, as previously described.

B. Other Non-Occupational Exposure

    Potential non-occupational dermal or inhalation exposure is
considered unlikely for this distinctly agricultural use (i.e., post-
harvest treatment of the harvested portions--pears and apples--of
agricultural plants).
    1. Dermal exposure. Non-occupational dermal exposure to Candida
oleophila Strain O, when used as labeled, is expected to be negligible
because it is limited to post-harvest agricultural treatment of apples
and pears. However, should non-occupational dermal exposure occur
through treated food commodities, the risk posed by this low toxicity
microbe is likely to be minimal based on the toxicity and pathogenicity
tests described in Unit III. Furthermore, exposure would not be
expected to exceed background as similar yeasts and those in the genus
and species, Candida oleophila, are commonly associated with particular
food commodities.

    2. Inhalation exposure. Non-occupational inhalation exposure to
Candida oleophila Strain O, when used as labeled, is expected to be
negligible because of the method of application (i.e., dipping and
drenching of apples and pears), which then allows sufficient time for
drying prior to distribution to consumers. Furthermore, most of the
residual yeast on apples and pears is trapped in the cuticular wax and
it is unlikely to be inhaled by consumers.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to
consider the cumulative effects of exposure to Candida oleophila Strain
O and to other substances that have a common mechanism of toxicity.
These considerations include the possible cumulative effects of such
residues on infants and children. As demonstrated in Unit III., Candida
oleophila Strain O is not toxic or pathogenic to mammals via several
routes of exposure. Additionally, there are no other Candida oleophila
strains currently registered as pesticides with the Agency.
Consequently, since this microbial pesticide has no demonstrated
toxicity, there is no reason to anticipate cumulative effects from the
residues of this product with other related microbial pesticides.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues, and the cumulative effects on infants and children
of the residues and other substances with a common mechanism of
toxicity. In addition, FFDCA section 408(b)(2)(C) also provides that
EPA shall apply an additional tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database unless EPA
determines that a different margin of safety will be safe for infants
and children. Margins of exposure (safety), which are often referred to
as uncertainty factors, are incorporated into EPA risk assessment
either directly or through the use of a margin of exposure analysis, or
by using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk.
    Based on the acute toxicity and pathogenicity data discussed in
Unit III., EPA concludes that there is a reasonable certainty that no
harm will result from aggregate exposure to the United States
population, including infants and children, to the residues of Candida
oleophila Strain O. This includes all anticipated dietary exposures and
all other exposures for which there is reliable information. The Agency
has arrived at this conclusion because the data available on Candida
oleophila Strain O do not demonstrate toxic, pathogenic, or infective
potential to mammals. Thus, there are no threshold effects of concern
and, as a result, the provision requiring an additional margin of
safety does not apply. Further, the considerations of consumption
patterns, special susceptibility, and cumulative effects do not apply
to pesticides without a demonstrated significant adverse effect.

VII. Other Considerations

A. Endocrine Disruptors

    EPA is required, under Section 408(p) of the FFDCA, to develop a
screening program to determine whether certain substances (including
all pesticide active and other ingredients) ``may have an effect in
humans that is similar to an effect produced by naturally-occurring
estrogen, or other such endocrine effects as the Administrator may
designate.'' Following the recommendations of its Endocrine Disruptor
Screening and Testing Advisory Committee (EDSTAC), EPA determined that
there was a scientific basis for including, as part of its program,
androgen and thyroid hormone systems, in addition to the estrogen
hormone system. EPA also adopted EDSTAC's recommendation that the
program include evaluations of potential effects on wildlife.
    The Agency has no knowledge of Candida oleophila Strain O being an
endocrine disruptor, nor is this microbe related to any class of known
endocrine disruptors. Following several routes of exposure in rodents,
the Tier I toxicology data indicated that the immune system was still
intact and able to process and clear Candida oleophila Strain O from a
variety of organs or tissues. Additional data, specifically on the
endocrine effects of this microbial pesticide, are not required at this
time. Consequently, endocrine-related concerns did not impact the
Agency's safety finding for Candida oleophila Strain O. When the
appropriate screening and/or testing protocols being considered under
the Agency's Endocrine Disruptor Screening Program (EDSP) have been
developed and implemented, Candida oleophila Strain O may be subject to
additional screening and/or testing to better characterize effects
related to endocrine disruption.

B. Analytical Method(s)

    The Agency proposes to establish an exemption from the requirement
of a tolerance without any numerical limitation; therefore, the Agency
has concluded that an analytical method is not required for enforcement
purposes for Candida oleophila Strain O.

 C. Codex Maximum Residue Level

    No Codex maximum residue level exists for ECandida oleophila Strain
O.

VIII. Conclusions

    The results of the studies discussed in Unit III meet the safety
requirements of the Food Quality Protection Act (FQPA) of 1996. They
support an exemption from the requirement of a tolerance for the
residues of the microbial pesticide, Candida oleophila Strain O, on
apples and pears. In addition, the Agency is of the opinion that, if
the microbial active ingredient is used as allowed, aggregate exposure
and cumulative effects are not likely to harm the United States
population, including infants and children. Therefore, in response to
pesticide tolerance petition 7F7310, an exemption from the requirement
of a tolerance is established for the residues of the microbial
pesticide, Candida oleophila Strain O, on apples and pears when
applied/used as a post-harvest biofungicide.

 IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule 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 final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., 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 section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated:May 1, 2009.
Debra Edwards,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.1289 is added to subpart D to read as follows:

Sec.  180.1289  Candida oleophila Strain O; exemption from the
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
the residues of the microbial pesticide, Candida oleophila Strain O, on
apples and pears when applied/used as a post-harvest biofungicide.

[FR Doc. E9-10962 Filed 5-12-09; 8:45 am]

BILLING CODE 6560-50-S