[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)]
[Rules and Regulations]
[Pages 45819-45820]
[FR Doc No: 2018-19493]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2018-0727; Airspace Docket No. 18-AEA-15]
RIN 2120-AA66

Amendment of Class E Airspace; Lynchburg, VA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; technical amendment.

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

SUMMARY: This action amends the legal description of the Class E
airspace at Lynchburg Regional Airport-Preston Glenn Field Airport,
Lynchburg, VA. The NOTAM part-time status is removed from the Class E
airspace area designated as an extension to a Class D surface area.
This action does not affect the boundaries or operating requirements of
the airspace.

DATES: Effective 0901 UTC, November 8, 2018. 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 7400.11.B Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/airtraffic/publications/. For further information, you can
contact the Airspace Policy and Regulations Group, Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591;
telephone:<PHONE_NUMBER>. The Order is also available for inspection
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call (202)
741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Avenue, College Park, GA 30337; 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 U.S. Code. Subtitle 1, 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 makes a clerical correction removing the NOTAM part-time status
from the Class E airspace area designated as an extension at Lynchburg
Regional Airport-Preston Glenn Field, Lynchburg, VA.

History

    The FAA Aeronautical Information Services branch found the Class E
airspace area designated as an extension to a Class D surface area at
Lynchburg Regional Airport-Preston Glenn Field Airport, Lynchburg, VA,
was incorrectly identified as part time. This action also changes the
airport name to Lynchburg Regional Airport-Preston Glenn Field.
    Class E airspace designations are published in paragraph 6004 of
FAA Order 7400.11B dated August 3, 2017, and effective September 15,
2017, which is incorporated by reference in 14 CFR part 71.1. The Class
E airspace designations 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 7400.11B, Airspace Designations and
Reporting Points, dated August 3, 2017, and effective September 15,
2017. FAA Order 7400.11B is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11B lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by removing the NOTAM part-time status from the Class E
airspace area designated as an extension to a Class D airspace at
Lynchburg Regional Airport-Preston Glenn Field Airport, Lynchburg, VA.
The airport name also is changed from Lynchburg Regional-Preston Glenn
Field to Lynchburg Regional Airport-Preston Glenn Field.
    This is an administrative change and does not affect the
boundaries, or

operating requirements of the airspace, therefore, notice and public
procedure under 5 U.S.C. 553(b) are unnecessary.

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.
Therefore, this regulation: (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 only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does 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 5-6.5.a. 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.

Lists 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 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 7400.11B, Airspace Designations and Reporting
Points, dated August 3, 2017, effective September 15, 2017, is amended
as follows:

Paragraph 6004 Class E Airspace Designated as an Extension to Class
D or E Surface Area.

* * * * *

AEA VA E4 Lynchburg, VA [Amended]

Lynchburg Regional Airport-Preston Glenn Field, VA
    (Lat. 37[deg]19'31'' N, long. 79[deg]12'04'' W)
Lynchburg VORTAC
    (Lat. 37[deg]15'16'' N, long. 79[deg]14'11'' W)

    That airspace extending upward from the surface within 2.7 miles
each side of the Lynchburg VORTAC 020[deg] and 200[deg] radials
extending from the 4.5-mile radius of Lynchburg Regional Airport-
Preston Glenn Field to 1 mile south of the VORTAC and within 1.8
miles each side of the Lynchburg VORTAC 022[deg] radial extending
from the 4.5-mile radius of the airport to 11.3 miles northeast of
the VORTAC.

    Issued in College Park, Georgia, on August 28, 2018.
Ryan W. Almasy,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2018-19493 Filed 9-10-18; 8:45 am]
 BILLING CODE 4910-13-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on July 15, 2003

NOTICE OF ACTION TAKEN -- DOCKET OST 2003-15485

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  LUFTHANSA CITYLINE GmbH
                               Date Filed:  June 20, 2003

Relief requested:  Exemption under 49 U.S.C. 40109 to permit Lufthansa
CityLine to conduct, for a period of two years, scheduled foreign air
transportation of persons, property, and mail, by displaying the code of
United Air Lines on flights operated by Lufthansa CityLine wholly within
Germany, and, in addition, between points in Germany and points in third
countries.

Statement of Authorization under 14 CFR Part 212 to permit Lufthansa
CityLine to carry United Air Lines’ code, for an indefinite duration,
on flights operated by Lufthansa CityLine wholly within Germany, and, in
addition, between points in Germany and points in third countries.

If renewal, date and citation of last action:  New authority.

Applicant representative:  Ali M. Stoeppelwerth,<PHONE_NUMBER>
DOT analyst:  Allen F. Brown,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved, subject to conditions (see below).
                                   Action date:  July 15, 2003

Effective dates of authority granted:  The exemption authority granted
to the applicant is effective July 15, 2003, through July 15, 2005.  The
Statement of Authorization granted to the applicant is effective July
15, 2003, for an indefinite duration.

Basis for approval:  The authority is encompassed by the United
States-Germany Air Transport Agreement, as amended.  We found, based on
the record, that Lufthansa CityLine is substantially owned and
effectively controlled by citizens of Germany, properly licensed by its
homeland, and operationally and financially qualified to undertake the
proposed operations.

Conditions:  Except to the extent exempted or waived, the exemption
authority granted to Lufthansa CityLine is subject to the terms,
conditions, and limitations of our Foreign Air Carrier Standard
Exemption Conditions.

The code-share authority that we granted to Lufthansa CityLine is
subject to the following conditions:  1) This Statement of Authorization
will remain in effect only as long as Lufthansa CityLine and United
continue to hold the necessary underlying authority to operate the
code-share services at issue and their code-share agreement providing
for these operations remains in effect.  2) Lufthansa CityLine and/or
United must notify the Department no later than 30 days before they
begin any new code-share service under the code-share services
authorized here.  Such notice shall identify the market(s) to be served,
and the date on which the service will begin.  Such notices should be
filed in Docket OST-2003-15485.  3) Lufthansa CityLine and/or United
must promptly notify the Department (Office of International Aviation)
if the subject agreement providing for these operations is no longer
effective or the carriers decide to cease operating any or all of the
approved services.  (We expect this notice to be received within ten
days of such noneffectiveness or of such decision and filed in Docket
2003-15485).  4) The code-share operations conducted under this
authority must comply with 14 CFR Part 257 and with any amendments to
the Department’s regulations concerning code-share arrangements that
may be adopted.  5) Notwithstanding any provisions in the contract
between the subject carriers, our approval here is expressly conditioned
upon the requirements that the subject foreign air transportation be

sold in the name of the carrier holding out the service in computer
reservation systems and elsewhere; that the carrier selling such
transportation (that is, the carrier shown on the ticket) accept
responsibility for the entirety of the code-share journey for all
obligations established in its contract of carriage with the passenger;
and that the passenger liability of the operating carrier be unaffected.
 6) The operating carrier shall not permit the code of its U.S.
code-share partner to be carried on any flight that enters, departs, or
transits the airspace of any area for whose airspace the Federal
Aviation Administration has issued a flight prohibition.  7) The
authority to operate to third countries is subject to the condition that
any service provided under the statement of authorization shall be
consistent with all applicable agreements between the United States and
the foreign countries involved.  Furthermore, i) nothing in the award of
this blanket statement of authorization should be construed as
conferring upon Lufthansa CityLine and United rights (including
code-share, fifth freedom intermediates and/or beyond rights) to serve
markets where U.S. carrier rights are limited unless Lufthansa CityLine
and United notify us of their intent to serve such a market and unless
and until the Department has completed any necessary carrier-selection
procedures to determine which carrier(s) should be authorized to
exercise such rights (the 30-day notice provision set forth above in
this paragraph can be used for this notification); and ii) should there
be a request by any carrier to use the limited-entry route rights that
are included in Lufthansa CityLine’s and United’s authority by
virtue of the blanket statement of authorization granted here, but that
are not then being used by Lufthansa CityLine and United, the holding of
such authority will not be considered as providing any preference for
Lufthansa CityLine and United in a competitive carrier-selection
proceeding to determine which carrier(s) should be entitled to use the
authority at issue; and  8) The code-share authority granted here is
specifically conditioned so that neither carrier shall give any force or
effect to any contractual provisions between themselves that are
contrary to these conditions.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
_______________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp


[Federal Register Volume 76, Number 96 (Wednesday, May 18, 2011)]
[Notices]
[Page 28764]
[FR Doc No: 2011-12117]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP11-59-000]

Northwest Pipeline, GP; Notice of Availability of the
Environmental Assessment for the Proposed Molalla Capacity Replacement
Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) for the
Molalla Capacity Replacement Project (Project) proposed by Northwest
Pipeline GP (Northwest) in the above-referenced docket. Northwest
requests authorization to abandon, construct, and operate certain
natural gas pipeline facilities along its existing 2436 Camas/Eugene
pipeline system in Marion and Clackamas Counties, Oregon.
    The EA assesses the potential environmental effects of the
construction and operation of the Project in accordance with the
requirements of the National Environmental Policy Act of 1969 (NEPA).
The FERC staff concludes that approval of the Project, with appropriate
mitigating measures, would not constitute a major federal action
significantly affecting the quality of the human environment.
    Northwest proposes to construct, modify, and operate below and
aboveground facilities along their existing Camas to Eugene pipeline
system. Specifically, Northwest proposes to retire in-place
approximately 15 miles of 16-inch-diameter pipeline and associated
minor aboveground facilities; and to install approximately 7.8 miles of
20-inch-diameter pipeline loop and the necessary appurtenant
facilities.
    The EA has been placed in the public files of the FERC and is
available for public viewing on the FERC's Web site at http://www.ferc.gov using the eLibrary link. A limited number of copies of the
EA are available for distribution and public inspection at:

Federal Energy Regulatory Commission, Public Reference Room, 888 First
Street, NE., Room 2A, Washington, DC 20426,<PHONE_NUMBER>.

    Copies of the EA have been mailed to federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes; other
interested individuals and groups; newspapers and libraries in the
project area; and parties to this proceeding.
    Any person wishing to comment on the EA may do so. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
The more specific your comments, the more useful they will be. To
ensure that your comments are properly recorded and considered prior to
a Commission decision on the proposal, it is important that the FERC
receives your comments in Washington, DC on or before June 13, 2011.
    For your convenience, there are three methods you can use to submit
your comments to the Commission. In all instances, please reference the
project docket number (CP11-59-000) with your submission. The
Commission encourages electronic filing of comments and has dedicated
eFiling expert staff available to assist you at<PHONE_NUMBER> or
<EMAIL_ADDRESS>    (1) You may file your comments electronically by using the eComment
feature, which is located on the Commission's Web site at http://www.ferc.gov under the link to Documents and Filings. An eComment is an
easy method for interested persons to submit brief, text-only comments
on a project;
    (2) You may file your comments electronically by using the eFiling
feature, which is located on the Commission's Web site at http://www.ferc.gov under the link to Documents and Filings. With eFiling, you
can provide comments in a variety of formats by attaching them as a
file with your submission. New eFiling users must first create an
account by clicking on ``eRegister.'' You will be asked to select the
type of filing you are making. A comment on a particular project is
considered a ``Comment on a Filing''; or
    (3) You may file a paper copy of your comments at the following
address:

Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Room 1A, Washington, DC 20426.

    Although your comments will be considered by the Commission, simply
filing comments will not serve to make the commenter a party to the
proceeding. Any person seeking to become a party to the proceeding must
file a motion to intervene pursuant to Rule 214 of the Commission's
Rules of Practice and Procedures (18 CFR 385.214).\1\ Only intervenors
have the right to seek rehearing of the Commission's decision.
---------------------------------------------------------------------------

    \1\ Interventions may also be filed electronically via the
Internet in lieu of paper. See the previous discussion on filing
comments electronically.
---------------------------------------------------------------------------

    Affected landowners and parties with environmental concerns may be
granted intervenor status upon showing good cause by stating that they
have a clear and direct interest in this proceeding which would not be
adequately represented by any other parties. You do not need intervenor
status to have your comments considered.
    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC or on the
FERC Web site (http://www.ferc.gov) using the eLibrary link. Click on
the eLibrary link, click on ``General Search'' and enter the docket
number excluding the last three digits in the Docket Number field
(i.e., CP11-59). Be sure you have selected an appropriate date range.
For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to http://www.ferc.gov/esubscribenow.htm.

    Dated: May 11, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-12117 Filed 5-17-11; 8:45 am]
BILLING CODE 6717-01-P


EPA Registration Division contact: Laura Nollen,<PHONE_NUMBER>

Interregional Research Project Number 4 (IR-4)

Petition Number (PP#) 8E7428

EPA has received a pesticide petition 8E7428 from IR-4, IR-4 Project
Headquarters, Rutgers, The State University of NJ, 500 College Road
East, Suite 201 W, Princeton, NJ 08540, proposing, pursuant to section
408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346a(d), to amend 40 CFR part 180.474 by raising the existing tolerance
for residues of the fungicide tebuconazole
(alpha-[2-(4-chlorophenyl)-ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-tri
azole-1-ethanol), in or on the raw agricultural commodity cherry from
4.0 to 5.0 parts per million (ppm).  EPA has determined that the
petition contains data or information regarding the elements set forth
in section 408 (d) (2) of the FDDCA; however, EPA has not fully
evaluated the sufficiency of the submitted data at this time or whether
the data supports granting of the petition. Additional data may be
needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism.   SEQ CHAPTER \h \r 1 The nature of the residue in
plants and animals is adequately understood.  The residue of concern is
the parent compound only, as specified in 40 CFR 180.474.

	2. Analytical method.   SEQ CHAPTER \h \r 1 An enforcement method for
plant commodities has been validated on various commodities.  It has
undergone successful EPA validation and has been submitted for inclusion
in PAM II.  The animal method has also been approved as an adequate
enforcement method.

	3. Magnitude of residues. IR-4 received requests from South Carolina,
New Jersey, Illinois, Alabama, California, Texas, Oklahoma, and New York
for the use of tebuconazole as a minor post-harvest treatment on fresh
market cherries. To support these requests, magnitude of residue data
were collected from EPA regions 5, 10, and 11. Field trials were
conducted in Michigan (region 5), California (region 10), and Washington
(two trials, region 11). Tebuconazole residues in treated samples ranged
from 0.33 to 3.55 ppm.

B. Toxicological Profile

	1. Acute toxicity.    SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1
Tebuconazole exhibits moderate toxicity. The rat acute oral LD50 = 3,933
milligram/kilogram (mg/kg) (category III); the rabbit acute dermal LD50
5,000 mg/kg (category IV); and the rat acute inhalation LC50 > 0.371
milligram/ Liter (mg/L) (category II). Technical tebuconazole was
slightly irritating to the eye (category III) and was not a skin
irritant (category IV) in rabbits. Tebuconazole was not a dermal
sensitizer.

	2. Genotoxicty. [  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 An Ames
test with Salmonella sp., a mouse micronucleus assay, a sister chromatid
exchange assay with Chinese hamster ovary cells, and an unscheduled DNA
synthesis assay with rat hepatocytes provided no evidence of
mutagenicity.

	3. Reproductive and developmental toxicity.   SEQ CHAPTER \h \r 1   SEQ
CHAPTER \h \r 1

a. 	In a developmental toxicity study, pregnant female rats were gavaged
with technical tebuconazole at levels of 0, 30, 60, or 120 mg/kg/day
between days 6 and 15 of gestation. The maternal NOAEL was 30 mg/kg/day
and the maternal LOAEL was 60 mg/kg/day based on increased absolute and
relative liver weights. The developmental NOAEL was 30 mg/kg/day and the
developmental LOAEL was 60 mg/kg/day based on delayed ossification of
thoracic, cervical and sacral vertebrae, sternum and limbs plus an
increase in supernumerary ribs.

b.	In a developmental toxicity study, pregnant female rabbits were
gavaged with technical tebuconazole at levels of 0, 10, 30, or 100
mg/kg/day between days 6 and 18 of gestation. The maternal NOAEL was 30
mg/kg/day and the maternal LOAEL was 100 mg/kg/day based on minimal
depression of body weight gains and food consumption. The developmental
NOAEL was 30 mg/kg/day and the developmental LOAEL was 100 mg/kg/day
based on increased postimplantation losses, malformations in 8 fetuses
out of 5 litters (including peromelia in 5 fetuses/4 litters;
palatoschisis in 1 fetus/1 litter), hydrocephalus and delayed
ossification.

c.	In a developmental toxicity study, pregnant female mice were gavaged
with technical tebuconazole at levels of 0, 10, 30, or 100 mg/kg/day
between days 6 and 15 of gestation (part 1 of study) or at levels of 0,
10, 20, 30, or 100 mg/kg/day between days 6 and 15 of gestation (part 2
of study). The maternal NOAEL was 10 mg/kg/day and the maternal LOAEL
was 20 mg/kg/day. Maternal toxicity (hepatocellular vacuolation and
elevations in AST, ALP and alkaline phosphatase) occurred at all dose
levels but was minimal at 10 mg/kg/day. Reduction in mean corpuscular
volume in parallel with reduced hematocrit occurred at doses greater
than or equal to 20 mg/kg/day. The liver was the target organ. The
developomental NOAEL was 10 mg/kg/day and the developmental LOAEL was 30
mg/kg/day based on an increase in the number of runts.

d.	In a developmental toxicity study, pregnant female mice were
administered dermal doses of technical tebuconazole applied at levels of
0, 100, 300, or 1,000 mg/kg/day between days 6 and 15 of gestation.
Equivocal maternal toxicity was observed 1,000 mg/kg/day.  The maternal
NOAEL was <nearly-eq> 1,000 mg/kg/day. The developmental NOAEL was 1,000
mg/kg/day.

e.	In a 2-generation reproduction study, rats were fed technical
tebuconazole at levels of 0, 100, 300, or 1,000 ppm, (0, 5, 15, or 50
mg/kg/day, males and females). The parental maternal NOAEL was 15
mg/kg/day and the parental LOAEL was 50 mg/kg/day based on depressed
body weights, increased spleen hemosiderosis and decreased liver and
kidney weights. The reproductive NOAEL was 15 mg/kg/day and the
reproductive LOAEL of 50 mg/kg/day based on decreased pup body weights
from birth through 3 - 4 weeks.

f.	In a developmental neurotoxicity study, pregnant female rats were fed
a nominal concentration of 0, 100, 300 or 1000 ppm of tebuconazole in
the diet.  The NOAEL for maternal toxicity in this study was 300 ppm
(based on mortality, body weight and feed consumption reductions, and
prolonged gestation in the1000 ppm dosage group).  The 1000 ppm dose
level was considered to be excessively toxic for the F1 offspring, based
on mortality, marked reductions in pup body weight and body weight gain,
reduction in pup absolute brain weight (at postpartum day (PD) 12 and
adult), a developmental delay in vaginal patency, and decreased
cerebellar thickness.  The effects on brain weight and morphology are
considered to represent incomplete compensation for the marked decrease
in body weight gain during development.  By approximately day 80
postpartum, the body weight had completely recovered in the females but
was still reduced (89% of the control group value) in the males.  The
brain weights had shown an incomplete recovery (90% to 93% of the
control group values) in both sexes. The EPA has determined that the
LOAEL for offspring toxicity in this study is 100  ppm..  Technical
grade tebuconazole did not cause any specific neurobehavioral effects in
the offspring when administered to the dams during gestation and
lactation at dietary concentrations up to and including 1000 ppm.

	4. Subchronic toxicity.   SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1

a. 	In a 90-day oral feeding study, rats were administered technical
tebuconazole at levels of 0, 100, 400, or 1,600 ppm (0, 8, 34.8, or
171.7 mg/kg/day for males or 0, 10.8, 46.5, or 235.2 mg/kg/day for
females). In males, the no observed adverse effect level (NOAEL) was
34.8 mg/kg/day and the lowest observed adverse effect level (LOAEL) was
171.7 mg/kg/day based on decreased body weight and decreased body weight
gain, adrenal vacuolation and spleen hemosiderosis. In females, the
NOAEL was 10.8 mg/kg/day and the LOAEL of 46.5 mg/kg/day was based on
adrenal vacuolation.

b.	In a 90-day oral feeding study, Beagle dogs were administered
technical tebuconazole at levels of 0, 200, 1,000, or 5,000 ppm (0, 74,
368, or 1,749 mg/kg/day for males or 0, 73, 352, or 1,725 mg/kg/day for
females). In females, the NOAEL was 73 mg/kg/day and the LOAEL was 352
mg/kg/day based on decreased body weight and decreased body weight gain,
decreased food consumption and increased liver N-demethylase activity.
At the highest dose tested (HDT), lens opacity was seen in all males and
in one female and cataracts were seen in three females.

c.	In a 21-day dermal toxicity study, rabbits were exposed dermally to
technical tebuconazole 5 days a week at doses of 0, 50, 250, or 1,000
mg/kg/day. No significant systemic effects were seen. The systemic NOAEL
> 1,000 mg/kg/day.

d.	In a 21-day inhalation toxicity study, rats were exposed to technical
tebuconazole (15 exposures - 6 hours/day for 3 weeks) at airborne
concentrations of 0, 0.0012, 0.0106, or 0.1558 mg/L/day. The NOAEL was
0.0106 mg/L/day and the LOAEL was 0.1558 mg/L/day based on piloerection
and induction of liver N-demethylase.]

<	5. Chronic toxicity.   SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1

a.	 In a 2-year combined chronic feeding/carcinogenicity study, rats
were administered technical tebuconazole at levels of 0, 100, 300, or
1,000 ppm (0, 5.3, 15.9, or 55 mg/kg/day for males or 0, 7.4, 22.8, or
86.3 mg/kg/day for females). In males, the NOAEL was 5.3 mg/kg/day and
the LOAEL was 15.9 mg/kg/day based on C-cell hyperplasia in the thyroid
gland. In females, the NOAEL was 7.4 mg/kg/day and the LOAEL was 22.8
mg/kg/day based on body weight depression, decreased hemoglobin,
hematocrit, mean corpuscular volume and mean corpuscular hemoglobin
concentration and increased liver microsomal enzymes. No evidence of
carcinogenicity was found at the levels tested.

b.	In a 1-year chronic feeding study, Beagle dogs were administered
technical tebuconazole at levels of 0, 40, 200, or 1,000 (weeks 1-39)
and 2,000 ppm (weeks 40-52) (0, 1, 5 or 25/50 mg/kg/day for males and
females). The NOAEL was 1 mg/kg/day and the LOAEL was 5 mg/kg/day based
on ocular lesions (lenticular and corneal opacity) and hepatic toxicity
(changes in the appearance of the liver and increased siderosis).

c.	In a 1-year chronic feeding study, Beagle dogs were administered
technical tebuconazole at levels of 0, 100, or 150 ppm (0, 3.0, or 4.4
mg/kg/day for males or 0, 3.0 or 4.5 mg/kg/day for females). The NOAEL
was 3.0 mg/kg/day and the LOAEL was 4.4 mg/kg/day based on adrenal
affects in both sexes. In males there was hypertrophy of adrenal zona
fasciculata cells amounting to 4/4 at 150 ppm and to 0/4 at 100 ppm and
in controls. Other adrenal findings in males included fatty changes in
the zona glomerulosa (3/4) and lipid hyperplasia in the cortex (2/4) at
150 ppm vs. (1/4) for both effects at 100 ppm and control dogs. In
females there was hypertrophy of zona fasciculata cells of the adrenal
amounting to 4/4 at 150 ppm and to 0/4 at 100 ppm and 1/4 in controls.
Fatty changes in the zona glomerulosa of the female adrenal amounted to
2/4 at 150 ppm and to 1/4 at 100 ppm and in controls.

d.	In a 91-week carcinogenicity study, mice were administered technical
tebuconazole at levels of 0, 500, or 1,500 ppm (0, 84.9, or 279
mg/kg/day for males or 0, 103.1, or 365.5 mg/kg/day for females).
Neoplastic histopathology consisted of statistically significant
increased incidences of hepatocellular neoplasms; adenomas (35.4%) and
carcinomas (20.8%) at 1,500 ppm in males and carcinomas (26.1%) at 1,500
ppm in females. Statistically significant decreased body weights and
increased food consumption were reported that were consistent with
decreased food efficiency at 500 and 1,500 ppm in males and at 1,500 ppm
in females. Clinical chemistry values (dose-dependent increases in
plasma GOT, GPT and Alkaline Phosphatase) for both sexes were consistent
with hepatotoxic effects at both 500 and 1,500 ppm. Relative liver
weight increases reached statistical significance at both 500 and 1,500
ppm in males and at 1,500 ppm in females. Non-neoplastic histopathology
included dose-dependent increases in hepatic pancinar fine fatty
vacuolation, statistically significant at 500 and 1,500 ppm in males and
at 1,500 ppm in females. Other histopathology included significant oval
cell proliferation in both sexes and dose-dependent ovarian atrophy that
was statistically significant at 500 and 1,500 ppm. The Maximum
Tolerated Dose (MTD) was achieved at or around 500 ppm.

	6. Animal metabolism.   SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 Rats
were gavaged with 1 or 20 mg/kg radio-labeled technical tebuconazole.
98.1 % of the oral dose was absorbed. Within 72 hours of dosing, over
87% of the dose was excreted in urine and feces. At sacrifice (72 hours
post dosing), total residue (-GI tract) amounted to 0.63% of the dose. A
total of 10 compounds were identified in the excreta. A large fraction
of the identified metabolites corresponded to successive oxidations
steps of a methyl group of the test material. At 20 mg/kg, changes in
detoxication patterns may be occurring.

	7. Metabolite toxicology.   SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1
NA

	8. Endocrine disruption.   SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 No
special studies investigating potential estrogenic or endocrine effects
of tebuconazole have been conducted. However, the standard battery of
required studies has been completed. These studies include an evaluation
of the potential effects on reproduction and development, and an
evaluation of the pathology of the endocrine organs following repeated
or long-term exposure. These studies are generally considered to be
sufficient to detect any endocrine effects but no such effects were
noted in any of the studies with either tebuconazole or its metabolites.

C. Aggregate Exposure

	1. Dietary exposure.   SEQ CHAPTER \h \r 1 The EPA’s April 18, 2008
Tebuconazole Human Health Risk Assessment included all uses including
the pending use for post-harvest use on cherries. This risk assessment
used the LOAEL of 8.8 mg/kg/day from a tebuconazole rat developmental
neurotoxicity study and an uncertainty factor of 300 to establish the
acute and chronic population adjusted doses (aPAD and cPAD,
respectively) at 0.029 mg/kg/day.

Results from EPA’s April 18, 2008 Tebuconazole Human Health Risk
Assessment show that that no harm to the overall U.S. population or any
population subgroup will result from the use of tebuconazole on
currently registered uses and pending uses including post-harvest
applications to cherries.

	i. Food. EPA’s acute dietary analysis reported in their April 18,
2008 Tebuconazole Human Health Risk Assessment showed that the most
highly exposed population subgroup was all infants < 1 year with an
exposure equal to 53% of the aPAD. The U.S. total population had an
exposure equal to 28% of the aPAD. The chronic analysis also showed that
the most highly exposed population subgroup was infants <1 year with an
exposure equal to 11% of the cPAD. The total U.S. population had a
chronic exposure equal to 4% of the cPAD. These exposure estimates are
below EPA’s level of concern.

	ii. Drinking Food. Acute and chronic exposure estimates from water are
included in the exposure values given above for food. These exposure
extimates are below EPA’s level of concern.

	2. Non-dietary exposure.   SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1
Tebuconazole is currently registered for use on the following
residential non-food sites: residential application to roses, flowers,
trees and shrubs; the formulation of wood-based composite products; wood
products for in-ground contact; plastics; glues and adhesives.  EPA in
their April 18 2008 Human Health Risk Assessment assessed residential
handler, post-application and other exposures (drift etc.) to
homeowners. EPA concluded that exposures to homeowners do not exceed the
level of concern

D. Cumulative Effects

	  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 Tebuconazole is a member of
the triazole class of systemic fungicides. At this time, the EPA has not
made a determination that tebuconazole and other substances that may
have a common mechanism of toxicity would have cumulative effects.
Therefore, for this tolerance petition, it is assumed that tebuconazole
does not have a common mechanism of toxicity with other substances and
only the potential risks of tebuconazole in its aggregate exposure are
considered. The cumulative effects of the primary common metabolites
(1,2,4-triazole and its TA and TAA conjugates are being addressed by the
US Triazole Task Force.

E. Safety Determination

	1. U.S. population.   SEQ CHAPTER \h \r 1 Based on the information
supplied under Aggregate Exposure describe above, there is reasonable
certainty that exposure from tebuconazole will not result in harm to the
adult U.S. population.

	2. Infants and children.[  SEQ CHAPTER \h \r 1 Based on the information
supplied under Aggregate Exposure describe above, there is reasonable
certainty that exposure from tebuconazole will not result in harm to
infants and children.

F. International Tolerance

	International tolerances/MRLs for tebuconazole have been established
for many crops including cherries and other stone fruit in many
countries. Codex and EU MRLs have been established for tebuconazole on
cherries at 5 ppm.