EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Laura Nollen,<PHONE_NUMBER>,
HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>

Interregional Research Project Number 4 (IR-4)

Petition Number (PP#) 2E8118

	EPA has received a pesticide petition, PP# 2E8118 from Interregional
Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W,
Princeton, NJ 08540 requesting, 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 180.544 by establishing a tolerance for residues of
methoxyfenozide, (3-methoxy-2-methylbenzoic acid
2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide) including its
metabolites and degradates in or on the raw agricultural commodities
under paragraph (a) in or on herb subgroup 19A, except chive at 400
parts per million (ppm); date at 7 ppm; caneberry subgroup 13-07A at 6
ppm; sorghum, grain, forage at 9 ppm; sorghum, grain, stover at 15 ppm;
sorghum, grain, grain at 4 ppm; sorghum, sweet, forage at 9 ppm;
sorghum, sweet, stover at 15 ppm; sorghum, sweet, grain at 4 ppm;
sorghum, sweet, stalk at 9 ppm; grain, aspirated grain fractions at 80
ppm; pea and bean, dried shelled, except soybean, subgroup 6C, except
pea, blackeyed, seed and pea, southern, seed at 0.5 ppm;  fruit, small,
vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 1 ppm; berry,
low growing, except cranberry, subgroup 13-07G at 1.5 ppm; fruit, pome,
group 11-10 at 1.5 ppm; vegetable, fruiting, group 8-10 at 2 ppm; sugar
apple at 0.6 ppm; cherimoya at 0.6 ppm; atemoya at 0.6 ppm; custard
apple at 0.6 ppm; ilama at 0.6 ppm; soursop at 0.6 ppm; and biriba at
0.6 ppm. Additionally, the petition requested to amend 40 CFR 180.544,
under paragraph (2)(d) by establishing a tolerance for indirect or
inadvertent residues of methoxyfenozide in or on rapeseed subgroup 20A
at 1.0 ppm and sunflower subgroup 20B at 1.0 ppm.

Upon approval of the tolerances in paragraph (a), the petition also
requests to amend the tolerance in paragraph (2)(d) from herb and spice,
group 19, except coriander, leaves at 4.5 ppm to spice subgroup 19B at
4.5 ppm. It is also proposed that the tolerance for residues of
methoxyfenozide in or on pea, dry, seed at 2.5 ppm; bean, dry, seed at
0.24 ppm; coriander, leaves at 30 ppm; grape at 1.0 ppm; strawberry at
1.5 ppm; fruit, pome, group 11 at 1.5 ppm; vegetable, fruiting, group 8
at 2.0 ppm; and okra at 2.0 ppm be removed upon the approval of the
proposed tolerances listed above.  EPA has determined that the petition
contains data or information regarding the elements set forth in section
408 (d)(2) of  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. Per the EPA analytical summary for methoxyfenozide
(D. Rate, US EPA, DP358341, June 10, 2009), the nature of the residue of
methoxyfenozide in plants has been studied in several plants (apple,
cotton, grape and rice) and is adequately understood.

	2. Analytical method. Per a recent 2012 decision on tolerances (M.
Collantes, US EPA, D388978, May 23, 2012), EPA stated adequate single
methods are available for tolerance enforcement in primary crops and
animal commodities.  Analytical methodology for the magnitude of residue
studies was based on Dow AgroSciences method GRM 02.25 “Determination
of Residues of Methoxyfenozide in High Moisture Crops by Liquid
Chromatography with Tandem Mass Spectrometry Detection“.

	3. Magnitude of residues. The proposed tolerances in Crop Subgroup 19A
(except chives), dates, Crop Subgroup 13-07A, and sorghum commodities
are all supported by  magnitude of residue studies in basil, dates,
caneberry, sorghum and  processed sorghum. The proposed tolerances in
Crop subgroup 13-07F (except fuzzy kiwifruit), Crop subgroup 13-07G,
Crop Group 11-10  and Crop group 8-10 are all supported by existing
tolerances on representative commodities for that crop or subgroup
(Grape, Strawberry, Crop Group 11 and Crop Group 8, respectively)
without the need for additional data.  The proposed tolerances for
inadvertent or indirect tolerances in oilseeds are supported by an EPA
2009 review of existing data (D. Rate, US EPA, D357983, July 22, 2009)
and a 2012 EPA recommendation (W. Drew, US EPA, D396397, May 1, 2012)
for reinstatement without the need for additional data.  In addition, a
request is made for international harmonization of tolerances for Pea
and bean, dried shelled, except soybean, subgroup 6C, except pea,
blackeyed, seed and pea, southern, seed.  Thus, the requested tolerances
are all adequately supported.

For Herb subgroup 19A, except chives, IR-4 recently completed trials in
fresh and dried basil with a 1 day PHI (IR-4 PR No. 07525, May 23,
2012).  Residues of methoxyfenozide were determined following 4 foliar
applications of Intrepid( 2F insecticide in at 5 field locations in
Florida, North Carolina, New Mexico, Wisconsin and British Columbia
during the 2009 growing season.  Methoxyfenozide was applied at a target
rate of 0.25 lb ai/A, for a total of approximately 1.0 lb ai/A.
Applications were made 9-11 days apart and marketable basil leaves and
stems were collected 1 day after the final application for analysis of
both fresh and dried samples.  The methoxyfenozide residues in fresh
basil ranged from a maximum of 47.2 ppm to a minimum of 9.26 ppm with a
43.4 ppm HAFT (Highest Average Field Trial) value at the PHI of 1 day.
In dried basil observed residues ranged from a maximum of 194 ppm to a
minimum of 56.3 ppm with HAFT value of 188 ppm.  Some decline was noted
over the 12 days within the decline trial. The limit of detection (LOD)
and the limit of quantitation (LOQ) values were calculated as 0.0031 ppm
and 0.0092 ppm, respectively for fresh basil, and 0.016 ppm and 0.049
ppm, respectively for dried basil.

For Date, IR-4 recently completed trials in dates with a 7 day PHI (IR-4
PR No. 10154, April 23, 2012).  Residues of methoxyfenozide were
determined following 3 foliar applications of Intrepid( 2F insecticide
at 4 field locations in California during the 2010 growing season.
Methoxyfenozide was applied at a target rate of 0.31 lb ai/A, for a
total of approximately 0.93 lb ai/A.  Applications were made 9-11 days
apart and marketable mature fruit was collected 7 days after the final
application.  Methoxyfenozide observed residues in date ranged from a
maximum of 3.3 ppm to a minimum of 1.5 ppm with a 3.1 ppm HAFT value at
the PHI of 7 day.  The LOD and LOQ values were calculated as 0.0013 ppm
and 0.0038 ppm, respectively for dates.

For Caneberry subgroup 13-07A, IR-4 recently completed trials in
blackberry and raspberry with a 3 day PHI (IR-4 PR No. 10470, February
6, 2012).  Residues of methoxyfenozide were determined following 3
foliar applications of Intrepid( 2F insecticide at 6 field locations in
Michigan, North Carolina, California and Oregon during the 2010 growing
season.  Methoxyfenozide was applied at a target rate of 0.25 lb ai/A,
for a total of approximately 0.75 lb ai/A.  Applications were made 6-8
days apart and marketable mature fruit was collected 3 days after the
final application.  Methoxyfenozide observed residues in blackberry
ranged from a maximum of 2.5 ppm to a minimum of 0.62 ppm with a 2.5ppm
HAFT value at the PHI of 3 day.  In raspberry observed residues ranged
from a maximum of 2.3 ppm to a minimum of 1.6 ppm with HAFT value of 2.2
ppm.  The LOD and LOQ values were calculated as 0.0040 ppm and 0.012
ppm, respectively for caneberry.

For Sorghum, IR-4 recently completed trials with a 3 day PHI for forage
and a 21 day PHI for stover and grain (IR-4 PR No. 07241, March 23,
2012).  Residues of methoxyfenozide were determined following 4 foliar
applications of Intrepid( 2F insecticide at 12 field locations in
Arkansas, North Carolina, North Dakota, Nebraska, New Mexico, South
Dakota, and Texas during the 2010 growing season.  Methoxyfenozide was
applied at a target rate of 0.12 lb ai/A, for a total of approximately
0.48 lb ai/A.  Applications were made 9-14 days apart and forage was
collected 2-3 days after the final application, and grain and stover
were collected 11-23 days after the final application.  Methoxyfenozide
observed residues in forage ranged from a maximum of 5.6 ppm to a
minimum of 0.7 ppm with a 5.0 ppm HAFT value at the PHI of 3 day.  In
stover observed residues ranged from a maximum of 9.7 ppm to a minimum
of 0.29 ppm with HAFT value of 2.8 ppm.   In grain observed residues
ranged from a maximum of 2.6 ppm to a minimum of 0.15 ppm with HAFT
value of 2.25 ppm.   Aspirated grain fractions (AGF) processed from bulk
grain samples had a residue of 17 ppm whereas the unprocessed grain from
the same trial had a residue of 0.48 ppm.  The syrup sample processed
from sweet sorghum stalks had the same residue (1.1 ppm) as the
unprocessed stalks.  The LOD and LOQ values were calculated as 0.0071
ppm and 0.0213 ppm, 0.0012 and 0.0037 ppm, 0.0026 and 0.0079 ppm, 0.0006
and 0.0019 ppm, 0.0003 and 0.0008 ppm, respectively for sorghum forage,
grain, stover, aspirated grain and syrup.

Tolerance requests for fruiting vegetable group 8-10, pome fruit group
11-10, subgroup 13-07F and subgroup 13-07G are crop group/subgroup
revisions based upon established tolerances.  Tolerances for sugar
apple, cherimoya, atemoya, custard apple, ilama, soursop, and biriba are
based upon the existing avocado tolerances and registration.

B. Toxicological Profile The toxicological profile for methoxyfenozide
which supports this petition to revise tolerances was reviewed in 2009
(Rate, EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009) and again in
the the 2012 Human Health review (Collantes, US EPA, D388978, May 23,
2012), and the endpoints for risk assessment are reiterated in EPA’s
most recent dietary assessment (EPA, Holman, D389738, March 2, 2012).
EPA has concluded “The toxicity database is considered complete for
the purposes of characterizing the hazard associated with
methoxyfenozide and for conducting a human health risk assessment.”
EPA has not established an acute reference dose for methoxyfenozide and
the chronic RfD is equivalent to the chronic PAD = 0.1 mg/kg/day,
because the FQPA SF has been reduced to 1X.

	1. Acute toxicity.  Per the 2009 Human Health review (Rate,
EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009) , no significant
acute hazards were attributable to a single exposure in the available
toxicology studies on methoxyfenozide including the acute neurotoxicity
study in rats, the developmental toxicity studying rats and the
developmental toxicity study in rabbits.  Since no acute toxicological
endpoints were established, no acute assessment is required.

	2. Genotoxicty. Per the 2009 Human Health review (Rate,
EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), methoxyfenozide
demonstrated a “lack of genotoxicity in an acceptable battery of
mutagenicity studies.”

	3. Reproductive and developmental toxicity. Per the 2009 Human Health
review (Rate, EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009),
methoxyfenozide “is not a developmental or reproductive toxicant”.
The toxicology data base available for methoxyfenozide included
acceptable developmental toxicity studies in both rats and rabbits as
well as a 2-generation reproductive toxicity study in rats.  The data
provided no indication of increased sensitivity of rats or rabbits to in
utero and/or postnatal exposure to methoxyfenozide.  EPA determined that
an additional safety factor was not needed for the protection of infants
and children (FQPA SF = 1x).

	4. Subchronic toxicity. Per the 2009 Human Health review (Rate,
EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), in subchronic and
chronic oral studies in rats, the most toxicologically significant
effects were mild anemia and mild effects on the liver, thyroid gland,
and adrenal gland. In subchronic and chronic oral studies in dogs, the
predominant toxic effect was anemia, which was often accompanied by
signs of a compensatory response.  In 2012 (Colantes, US EPA, D388978,
May 2012), new inhalation endpoints for Short-Term (1-30 days) and
Intermediate Term (1-6 months) were established with a NOAEL of 16.8
mg/kg/day for use in residential and occupational assessments.

	5. Chronic toxicity. Per the 2009 Human Health review (Rate,
EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), the chronic
population-adjusted dose (cPAD) is 0.1 mg/kg/day based on hematological
changes, liver toxicity, histopathological changes in thyroid and
possible adrenal toxicity observed at the LOAEL of 411 mg/kg/day in a
chronic toxicity study in rats.

	6. Animal metabolism. Per the 2009 Human Health review (Rate,
EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), in a metabolism
study in rats, 14C-methoxyfenozide was rapidly absorbed, distributed,
metabolized and almost completely excreted within 48 hours. The major
route of excretion was feces (86-97%) with lesser amounts in the urine
(5-13%).  Metabolism of methoxyfenozide in other animals (poultry and
ruminants) appears to be similar to its metabolism in rats.  Per the EPA
analytical summary for methoxyfenozide (D. Rate, US EPA, DP358341, June
10, 2009), the qualitative nature of methoxyfenozide residues in
livestock are adequately understood based on ruminant and poultry
metabolism studies.  The residue of concern is parent in milk and
ruminant tissues (except meat byproducts), poultry meat and fat.  The
residues of concern in meat byproducts and eggs are methoxyfenozide and
the RH-141,518 metabolite.

	7. Metabolite toxicology. Per the 2009 Human Health review (Rate,
EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 2009), in a metabolism
study in rats, methoxyfenozide is metabolized principally by
O-demethylation of the A-ring methoxy group and oxidative hydroxylation
of the B-ring methyl groups followed by conjugation with glucuronic
acid. No significant sex-related or dose-dependent differences in
metabolic disposition were noted. The methoxyfenozide glucuronide
conjugates are considered to be less toxic than the parent compound
because glucuronide conjugation is well known to be a commonly occurring
detoxification mechanism in mammalian species since it results in the
formation of more polar, more water-soluble metabolites which are
readily and easily excreted from the body (in this case, in the bile and
urine). Further, based on similarities of chemical structure, the
non-conjugated metabolites would be expected to be no more toxic than
the parent compound. Furthermore, HED has covered potential metabolite
exposure by inclusion of RH-141,518 along with the parent
methoxyfenozide in the residue of concern for certain commodities:
ruminant liver and kidney, eggs, poultry liver and poultry meat
byproducts.

	8. Endocrine disruption. The available mammalian toxicity and
toxicokinetic studies on methoxyfenozide, including a 2-generation
reproduction study, developmental toxicity studies in two species, and
repeat dose toxicity studies ranging from 28 days to 2 year studies in
three species (rat, mouse, and dog), do not demonstrate that
methoxyfenozide possesses endocrine disrupting properties that are
relevant to humans.

C. Aggregate Exposure

).  The Dietary Exposure Evaluation Model™ (DEEM-FCID, ver. 3.14)
software was employed.  DEEM contains food consumption data based on
NHANES 2-day food Consumption data for 2003 to 2008 and food translation
to RACs, as indicated by EPA/USDA FCID recipe set as of February 2012.

	i. Food. A chronic assessment was conducted to evaluate potential
chronic dietary exposure of the U.S. population subgroups to residues of
methoxyfenozide.  These analyses cover all registered crops, as well as
revised proposed tolerances.  The current dietary assessment is an
unrefined Tier I assessment using tolerance values and 100% crop-treated
assumption to estimate dietary exposure to methoxyfenozide and default
processing factors for all food commodities, with the exception of a
methoxyfenozide-specific processing factor for orange juice (0.2X).
Although the proposed sorghum uses alter the MRBD livestock burden
calculations very slightly, existing tolerances for meat and milk are
sufficient to cover the very small change and no increase in tolerance
for animal commodities is needed.

	ii. Drinking water. There are no water-related exposure data from
monitoring to complete a quantitative drinking water exposure analysis
and risk assessment for methoxyfenozide.  The previous EPA estimates of
33.1 ppb have recently been conservatively increased by EFED based on
new model assumptions in 2012 (Gebken, US EPA, D388876, May 23, 2012).
For potential drinking water exposures the new value of 43.4 ppb has
been directly incorporated in the DEEM-FCID into the food categories
“water, direct, all sources” and “water, indirect, all sources.”

Per the 2009 Human Health review (Rate, EPA-HQ-OPP-2009-0012-0004,
D357983, July 22, 2009), the established chronic endpoints are cRfD =
cPAD = 0.10 mg/kg/day.  The Tier-I DEEM exposure for food and water with
revised proposed tolerances resulted in an estimated exposure of
0.024775 mg/kg/day for the US general population which is 24.8% of the
chronic RfD.  For the most highly exposed population subgroup, children
1 to 2 years old, the estimated exposure is 0.06666 mg/kg/day at 66.7%
of cPAD.  These results are conservative (health protective) risk
estimates.  Refinements such as use of percent crop-treated information
and/or anticipated residue values would yield lower estimates of chronic
dietary exposure.

	2. Non-dietary exposure. A new use in ornamentals was recently approved
for methoxyfenozide in 2009.  Per the 2012 review (Collantes, US EPA,
D388978, May 23, 2012), EPA made the conservative interpretation that
the label did not preclude homeowner use on ornamentals. Thus in
accordance with FQPA, EPA conducted an aggregate assessment to include
residential handler exposure for adults.  The dietary exposure of the
general adult US population was aggregated with exposure estimates from
residential use of a backpack sprayer treatment of ornamentals.  The
calculated exposure resulted in an aggregate MOE of 670, which is
significantly higher than the stated LOC of 100 for methoxyfenozide, and
thus is not of concern.  The proposed tolerances in this petition do not
make significant contributions to the dietary consumption patterns.
Thus the small change in the dietary contribution did not result in a
change in MOE for adults; it remains 670 and hence the risk estimate is
not of concern for adults.  It is also noted that for children, the EPA
concluded that: “there are no residential uses of methoxyfenozide that
would result in significant postapplication exposure to children, based
on ornamental use only.  Therefore the aggregate exposure and risk for
children is equivalent to those from food and water.”

D. Cumulative Effects

	Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency considers
“available information” concerning the cumulative effects of a
particular pesticide’s residues and “other substances that have a
common mechanism of toxicity.”  EPA does not have, at this time,
available data to determine whether methoxyfenozide has a common
mechanism of toxicity with other substances or how to include this
pesticide in a cumulative risk assessment.  Unlike other pesticides for
which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, methoxyfenozide does not appear to produce a
toxic metabolite produced by other substances.  For the purposes of this
tolerance action, therefore, it is assumed that methoxyfenozide does not
have a common mechanism of toxicity with other substances.

E. Safety Determination

	1. U.S. population. Using the DEEM 3.14 exposure assumptions described
above, the dietary and water exposure to methoxyfenozide from the
current and proposed new tolerances will utilize 24.8% of the chronic
RfD for the US population.  EPA generally has no concern for exposures
below 100% of the chronic RfD. It is concluded that there is a
reasonable certainty that no harm will result to US-general population
from dietary exposure to methoxyfenozide residues. When the food, water
and residential exposures are aggregated for adults, the resulting MOEs
are 670, which are well above the LOC of 100; values above the LOC are
typically not of a concern for the Agency.

	2. Infants and children. Per the 2009 Human Health review (Rate,
EPA-HQ-OPP-2009-0012-0004, D357983, July 22, 20090, EPA has previously
determined that an additional safety factor was not needed for the
protection of infants and children (FQPA SF = 1x).  Using the DEEM
exposure assumptions described above for the dietary and water exposure
to methoxyfenozide with the current and proposed new tolerances, the
highest exposed subpopulation is children 1-2 years at 66.7% of the
cPAD.  EPA generally has no concern for exposures below 100% of the cPAD
because the cPAD represents the level at or below which daily aggregate
dietary exposure over a lifetime will not pose appreciable risks to
human health.

F. International Tolerances

	Several governing bodies have established Maximum Residue Levels (MRLs)
for methoxyfenozide in a variety of crops.  The related international
MRLs are found in the following table based on a review of MRLs compiled
by searches in the USDA MRL database ( HYPERLINK
"http://www.mrldatabase.com/results.cfm"
http://www.mrldatabase.com/results.cfm ), Homologa ( HYPERLINK
"http://www.homologa.com/" http://www.homologa.com/ ), the EU SANCO
website ( HYPERLINK
"http://ec.europa.eu/sanco_pesticides/public/index.cfm"
http://ec.europa.eu/sanco_pesticides/public/index.cfm ), Japan MRL
listing ( HYPERLINK
"http://www.m5.ws001.squarestart.ne.jp/foundation/agrdtl.php?a_inq=75700
"
http://www.m5.ws001.squarestart.ne.jp/foundation/agrdtl.php?a_inq=75700
) and the Australian MRL website ( HYPERLINK
"http://www.comlaw.gov.au/Series/F2008B00619"
http://www.comlaw.gov.au/Series/F2008B00619 ) .  Homologa is a third
party database; IR-4 makes no claim regarding the verification of these
values relative to the individual national authoritative sources.

Commodity	Existing MRLa

-

T

W

X

k

l

t

t

v

œ

¯

²

³

´

¶

Â

Ã

Ä

Å

Ù

Ü

æ

ç

è

é

h

k

n

r

+r

s

t

u

v

ƒ

©

³

Ä

Å

Ì

Ö

é

h¦

Cane fruit, Dates, Herbs	0.02*	EU SANCO

Sorghum	0.05*	EU SANCO

Rape seed (Bird rapeseed, turnip rape)	0.05*	EU SANCO

Sunflower seed	0.05*	EU SANCO

Herbs	T20	Australia

Cherimoya (Custard apple, sugar apple (sweetsop), Ilama and other medium
sized Annonaceae)	0.6	EU SANCO

Soursop (guanabana)	0.02*	EU SANCO

Custard apple	0.3	Australia

aThe * and T notations are direct translations from the country website
listings.

 PAGE

 PAGE   8


[Federal Register Volume 78, Number 218 (Tuesday, November 12, 2013)]
[Notices]
[Page 67356]
[FR Doc No: 2013-26967]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP14-78-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Negotiated Rate--Nicor to be effective 11/1/2013.
    Filed Date: 10/29/13.
    Accession Number: 20131029-5057.
    Comments Due: 5 p.m. ET 11/12/13.

    Docket Numbers: RP14-79-000.
    Applicants: Equitrans, L.P.
    Description: Equitrans, L.P. Operational Purchases and Sales.
    Filed Date: 10/29/13.
    Accession Number: 20131029-5103.
    Comments Due: 5 p.m. ET 11/12/13.

    Docket Numbers: RP14-80-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Tennessee Gas Pipeline Company, L.L.C. submits tariff
filing per 154.204: Volume No. 2--MPP Project--Chesapeake--Revised
Exhibit A to be effective 11/1/2013.
    Filed Date: 10/29/13.
    Accession Number: 20131029-5108.
    Comments Due: 5 p.m. ET 11/12/13.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR Sec.  385.211 and Sec.  385.214) on or
before 5:00 p.m. Eastern time on the specified comment date. Protests
may be considered, but intervention is necessary to become a party to
the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 30, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-26967 Filed 11-8-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 155 (Friday, August 10, 2018)]
[Rules and Regulations]
[Pages 39581-39583]
[FR Doc No: 2018-16735]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 83, No. 155 / Friday, August 10, 2018 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0168; Product Identifier 2017-NM-135-AD; Amendment
39-19344; AD 2018-16-04]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Airbus SAS Model A318, A319, and A320 series airplanes, and Model A321-
111, -112, -131, -211, -212, -213, -231, -232, -251N, -253N, and -271N
airplanes. This AD was prompted by a revision of an airworthiness
limitations document that specifies more restrictive maintenance
requirements and airworthiness limitations. This AD requires revising
the maintenance or inspection program, as applicable, to incorporate
the specified maintenance requirements and airworthiness limitations.
We are issuing this AD to address the unsafe condition on these
products.

DATES: This AD is effective September 14, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September
14, 2018.

ADDRESSES: For service information identified in this final rule,
contact Airbus SAS, Airworthiness Office--EIAS, Rond-Point Emile
Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36
96; fax +33 5 61 93 44 51; email [email protected];
internet http://www.airbus.com. You may view this service information
at the FAA, Transport Standards Branch, 2200 South 216th St., Des
Moines, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0168.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0168; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) is in the ADDRESSES section. Comments will be available in the AD
docket shortly after receipt.

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

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Airbus SAS Model
A318, A319, and A320 series airplanes, and Model A321-111, -112, -131,
-211, -212, -213, -231, -232, -251N, -253N, and -271N airplanes. The
NPRM published in the Federal Register on April 2, 2018 (83 FR 13885).
The NPRM was prompted by a revision of an airworthiness limitations
document that specifies more restrictive maintenance requirements and
airworthiness limitations. The NPRM proposed to require revising the
maintenance or inspection program, as applicable, to incorporate the
specified maintenance requirements and airworthiness limitations.
    We are issuing this AD to address the risks associated with the
effects of aging on airplane systems. Such effects could change system
characteristics, leading to an increased potential for failure of
certain life-limited parts, and reduced structural integrity or
controllability of the airplane.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2017-0170, dated September 7, 2017 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for certain Airbus SAS
Model A318, A319, and A320 series airplanes, and Model A321-111, -211,
-212, -213, -231, -232, -251N, -253N, and -271N airplanes. The MCAI
states:

    The System Equipment Maintenance Requirements (SEMR) for Airbus
A320 family aeroplanes, which are approved by EASA, are currently
defined and published in the Airbus A318/A319/A320/A321
Airworthiness Limitations Section (ALS) Part 4 document. These
instructions have been identified as mandatory for continued
airworthiness.
    Failure to accomplish these instructions could result in an
unsafe condition.
    Previously, EASA issued AD 2016-0093 [which corresponds to FAA
AD 2017-19-24, Amendment 39-19054 (82 FR 44900, September 27, 2017)
(``AD 2017-19-24''),] to require accomplishment of all maintenance
tasks as described in ALS Part 4 at Revision 03. ALS Part 4 Revision
04 was not mandated because no significant changes were introduced
with this Revision. The new ALS Part 4 Revision 05 (hereafter
referred to as `the ALS' in this [EASA] AD) includes new and/or more
restrictive requirements and extends the applicability to model
A320-251N, A320-271N, A321-251N, A321-253N and A321-271N aeroplanes.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2016-0093, which is superseded, and requires
accomplishment of all tasks as described in the ALS.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0168.

Comments

    We gave the public the opportunity to participate in developing
this final rule. We have considered the comment received. United
Airlines indicated that they had no objection to the NPRM.

Explanation of Changes to Applicability

    We have revised the applicability of this AD to identify model
designations as published in the most recent type certificate data
sheet for the affected models.

Conclusion

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

Related Service Information Under 1 CFR Part 51

    Airbus SAS has issued Airbus SAS A318/A319/A320/A321 Airworthiness
Limitations Section (ALS) Part 4, ``System Equipment Maintenance
Requirements (SEMR),'' Revision 05, dated April 6, 2017. This service
information describes preventive maintenance requirements and includes
updated inspections and intervals to be incorporated into the
maintenance or inspection program. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 1,133 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:
    We have determined that revising the maintenance or inspection
program takes an average of 90 work-hours per operator, although this
figure may vary from operator to operator. In the past, we have
estimated that this action takes 1 work-hour per airplane. Since
operators incorporate maintenance or inspection program changes for
their affected fleet(s), we have determined that a per-operator
estimate is more accurate than a per-airplane estimate. Therefore, we
estimate the total cost per operator to be $7,650 (90 work-hours x $85
per work-hour).

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2018-16-04 Airbus SAS: Amendment 39-19344; Docket No. FAA-2018-0168;
Product Identifier 2017-NM-135-AD.

(a) Effective Date

    This AD is effective September 14, 2018.

(b) Affected ADs

    This AD affects AD 2017-19-24, Amendment 39-19054 (82 FR 44900,
September 27, 2017) (``AD 2017-19-24'').

(c) Applicability

    This AD applies to the Airbus SAS airplanes identified in
paragraphs (c)(1) through (c)(4) of this AD, certificated in any
category, with an original certificate of airworthiness or original
export certificate of airworthiness issued on or before April 6,
2017.
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes.
    (3) Model A320-211, -212, -214, -216, -231, -232, -233, -251N,
and -271N airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, -232, -
251N, -253N, and-271N airplanes.

(d) Subject

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

(e) Reason

    This AD was prompted by a revision of an airworthiness
limitations document that specifies more restrictive maintenance
requirements and airworthiness limitations. We are issuing this AD
to mitigate the risks associated with the effects of aging on
airplane systems. Such effects could change system characteristics,
leading to an increased potential for failure of certain life-
limited parts, and reduced structural integrity or controllability
of the airplane.

(f) Compliance

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

(g) Revision of Maintenance or Inspection Program

    Within 90 days after the effective date of this AD, revise the
maintenance or inspection program, as applicable, to incorporate
Airbus SAS A318/A319/A320/A321 Airworthiness Limitations Section
(ALS) Part 4, ``System Equipment Maintenance Requirements (SEMR),''
Revision 05, dated April 6, 2017. The initial compliance time for
doing the revised actions is at the applicable time specified in
Airbus SAS A318/A319/A320/A321 ALS Part 4, ``System Equipment
Maintenance Requirements (SEMR),'' Revision 05, dated April 6, 2017.

(h) No Alternative Actions or Intervals

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

(i) Terminating Action for AD 2017-19-24

    Accomplishing the actions required by this AD terminates all
requirements of AD 2017-19-24.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (k)(2) of this AD. Information
may be emailed to: [email protected]. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or the European Aviation
Safety Agency (EASA); or Airbus SAS's EASA Design Organization
Approval (DOA). If approved by the DOA, the approval must include
the DOA-authorized signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2017-0170, dated September 7,
2017, for related information. This MCAI may be found in the AD
docket on the internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2018-0168.
    (2) For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Airbus SAS A318/A319/A320/A321 Airworthiness Limitations
Section (ALS) Part 4, ``System Equipment Maintenance Requirements
(SEMR),'' Revision 05, dated April 6, 2017.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EIAS, Rond-Point Emile Dewoitine
No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax
+33 5 61 93 44 51; email [email protected]; internet
http://www.airbus.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on July 23, 2018.
James Cashdollar,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-16735 Filed 8-9-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: July 14, 2006 (Volume 71, Number 135)]
[Notices]
[Page 40090]
[DOCID:fr14jy06-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-425-000]

Transcontinental Gas Pipe Line Corporation; Notice of Refund
Report

July 6, 2006.
    Take notice that, on June 30, 2006, Transcontinental Gas Pipe Line
Corporation (Transco) tendered for filing, pursuant to section 3.4 of
Transco's Rate Schedule PAL and section 7 of Transco's Rate Schedule
ICTS, a Report of Refund detailing PAL and ICTS revenue sharing refunds
totaling $415,136.69 of principal and interest paid on June 21, 2006.
Transco states that the refund report is for the annual period May 1,
2005 through April 30, 2006.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the date as indicated
below. Anyone filing an intervention or protest must serve a copy of
that document on the Applicant. Anyone filing an intervention or
protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on July 13, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-11174 Filed 7-13-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 10 (Friday, January 15, 2016)]
[Notices]
[Pages 2219-2220]
[FR Doc No: 2016-00675]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Advisory Committee: Vaccines and Related Biological Products
Advisory Committee, Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Vaccines and Related Biological Products Advisory
Committee by the Commissioner of Food and Drugs (the Commissioner). The
Commissioner has determined that it is in the public interest to renew
the Vaccines and Related Biological Products Advisory Committee for an
additional 2 years beyond the charter expiration date. The new charter
will be in effect until December 31, 2017.

DATES: Authority for the Vaccines and Related Biological Products
Advisory Committee will expire on December 31, 2017, unless the
Commissioner formally determines that renewal is in the public
interest.

FOR FURTHER INFORMATION CONTACT: Sujata Vijh, Division of Scientific
Advisors and Consultants, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
6128, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the

Vaccines and Related Biological Products Advisory Committee. The
committee is a discretionary Federal advisory committee established to
provide advice to the Commissioner. The Vaccines and Related Biological
Products Advisory Committee advises the Commissioner or designee in
discharging responsibilities as they relate to helping to ensure safe
and effective vaccines and related biological products for human use
and, as required, any other product for which the Food and Drug
Administration has regulatory responsibility.
    The Committee reviews and evaluates data concerning the safety,
effectiveness, and appropriate use of vaccines and related biological
products which are intended for use in the prevention, treatment, or
diagnosis of human diseases, and, as required, any other products for
which the Food and Drug Administration has regulatory responsibility.
The Committee also considers the quality and relevance of FDA's
research program which provides scientific support for the regulation
of these products and makes appropriate recommendations to the
Commissioner of Food and Drugs.
    The Committee shall consist of a core of 15 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of immunology, molecular biology, rDNA, virology; bacteriology,
epidemiology or biostatistics, vaccine policy, vaccine safety science,
federal immunization activities, vaccine development including
translational and clinical evaluation programs, allergy, preventive
medicine, infectious diseases, pediatrics, microbiology, and
biochemistry. Members will be invited to serve for overlapping terms of
up to four years. Almost all non-Federal members of this committee
serve as Special Government Employees. Ex Officio voting members one
each from the Department of Health and Human Services, the Centers for
Disease Control and Prevention, and the National Institutes of Health
may be included. The core of voting members may include one technically
qualified member, selected by the Commissioner or designee, who is
identified with consumer interests and is recommended by either a
consortium of consumer-oriented organizations or other interested
persons. In addition to the voting members, the Committee may include
one non-voting member who is identified with industry interests. There
may also be an alternate industry representative.
    The Commissioner or designee shall have the authority to select
members of other scientific and technical FDA advisory committees
(normally not to exceed 10 members) to serve temporarily as voting
members and to designate consultants to serve temporarily as voting
members when: (1) Expertise is required that is not available among
current voting standing members of the Committee (when additional
voting members are added to the Committee to provide needed expertise,
a quorum will be based on the combined total of regular and added
members), or (2) to comprise a quorum when, because of unforeseen
circumstances, a quorum is or will be lacking. Because of the size of
the Committee and the variety in the types of issues that it will
consider, FDA may, in connection with a particular committee meeting,
specify a quorum that is less than a majority of the current voting
members. The Agency's regulations (21 CFR 14.22(d)) authorize a
committee charter to specify quorum requirements. If functioning as a
medical device panel, a non-voting representative of consumer interests
and a non-voting representative of industry interests will be included
in addition to the voting members.
    Further information regarding the most recent charter and other
information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm129571.htm or
by contacting the Designated Federal Officer (see FOR FURTHER
INFORMATION CONTACT). In light of the fact that no change has been made
to the committee name or description of duties, no amendment will be
made to 21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: January 11, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-00675 Filed 1-14-16; 8:45 am]
 BILLING CODE 4164-01-P