[Federal Register Volume 78, Number 250 (Monday, December 30, 2013)]
[Proposed Rules]
[Pages 79359-79362]
[FR Doc No: 2013-31258]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0023; FRL-9903-69]

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

AGENCY: Environmental Protection Agency (EPA).

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

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

DATES: Comments must be received on or before January 29, 2014.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest as shown
in the body of this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.

    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (BPPD) (7511P), telephone number: (703)
305-7090, email address<EMAIL_ADDRESS>or Lois Rossi,
Registration Division (RD) (7505P), telephone number:<PHONE_NUMBER>,
email address<EMAIL_ADDRESS>Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001. As part of the mailing address, include the
contact person's name, division, and mail code.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help

address potential environmental justice issues, the Agency seeks
information on any groups or segments of the population who, as a
result of their location, cultural practices, or other factors, may
have atypical or disproportionately high and adverse human health
impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What action is the agency taking?

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

New Tolerance

    1. PP 3E8201. (EPA-HQ-OPP-2013-0729). Interregional Research
Project Number 4 (IR-4), 500 College Road East, Suite 201 W.,
Princeton, NJ 08540, requests to establish a tolerance in 40 CFR part
180 for residues of the desiccant, defoliant, and herbicide paraquat
dichloride, (1,1'-dimethyl-4,4'-bipyridinium-ion) derived from
application of the dichloride salt (calculated as the cation) in or on
tuberous and corm vegetables subgroup (Crop subgroup 1C) at 0.5 parts
per million (ppm). An analytical method (spectrometric method) has been
accepted and published in the Pesticide Analytical Manual (PAM Vol. II)
for the enforcement of tolerances in plant commodities. (RD)
    2. PP 3E8202. (EPA-HQ-OPP-2013-0712). Interregional Research
Project Number 4 (IR-4), 500 College Road East, Suite 201 W.,
Princeton, NJ 08540, requests to establish a tolerance in 40 CFR part
180 for the residues of the herbicide sulfentrazone, (N-[2,4-dichloro-
5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide) and its metabolite HMS (N-(2,4-dichloro-
5-(4-(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-
triazol-1-yl)phenyl)methanesulfonamide, calculated as the
stoichiometric equivalent of sulfentrazone, in or on apple at 0.15 ppm.
There is a practical analytical method for detecting and measuring
levels of sulfentrazone and its metabolites in or on food with a limit
of quantitation that allows monitoring of food with residues at or
above the levels set or proposed in the tolerances. The analytical
enforcement method for sulfentrazone was used with minor modification
that eliminated several clean-up and derivatization steps that was
required for gas chromatography/mass spectrometry detection (GC/MSD),
but not for liquid chromatograph/tandem mass spectrometry (LC/MS/MS).
The analytical method for sulfentrazone involves separate analyses for
parent and its metabolites. The parent is analyzed by evaporation and
reconstitution of the sample prior to analysis by LC/MS/MS GC/ECD. The
metabolites samples were refluxed in the presence of acid and cleaned
up with solid phase extraction prior to analysis by LC/MS/MS. (RD)
    3. PP 3E8203. (EPA-HQ-OPP-2013-0730). Interregional Research
Project Number 4 (IR-4), 500 College Road East, Suite 201 W.,
Princeton, NJ 08540, requests to establish tolerances in 40 CFR part
180 for the combined residues of the insecticide spinetoram, expressed
as a combination of XDE-175-J: 1-H-as-indaceno[3,2-d]oxacyclododecin-
7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-a-L-
mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-
methyl-2H-pyran-2-yl] oxy]-9-ethyl-
2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro 14-methyl-
(2R,3aR,5aR,5bS,9S,13S, 14R,16aS,16bR); XDE-175-L: 1H-as-indaceno[3,2-
d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-a-
L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-
methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,
12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-
(2S,3aR,5aS,5bS,9S,13S,14R,16aS, 16bS); ND-J:
(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-9-ethyl-14-methyl-13-
[[(2S,5S,6R)-6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-
7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-2-yl 6-deoxy-3-O-
ethyl-2,4-di-O-methyl-alpha-L-mannopyranoside; and NF-J: (2R,3S,6S)-6-
([(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-3-O-ethyl-2,4-di-O-
methyl-alpha-L-mannopyranosyl) oxy]-9-ethyl-14-methyl-7,15-dioxo-
2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-as-
indaceno[3,2-d]oxacyclododecin-13-yl]oxy)-2-methyltetrahydro-2H-pyran-
3-yl(methyl)formamide in or on the following raw agricultural
commodities: Coffee, green bean at 0.2 ppm; coffee, instant at 0.4 ppm;
coffee, roasted bean at 0.4 ppm; cottonseed subgroup 20C at 0.04 ppm;
caneberry subgroup 13-07A at 0.7 ppm; bushberry subgroup 13-07B, except
lingonberry at 0.25 ppm; fruit, small, vine climbing, except fuzzy
kiwifruit, subgroup 13-07F at 0.5 ppm; berry, low growing, subgroup 13-
07G, except blueberry, lowbush, and cranberry at 1.0 ppm; fruit, pome
group 11-10 at 0.2 ppm; vegetable, fruiting, group 8-10 at 0.4 ppm;
fruit, citrus, group 10-10 at 0.3 ppm; fruit, stone, group 12-12 at 0.2
ppm; onion, bulb, subgroup 3-07A at 0.1 ppm; onion, green, subgroup 3-
07B at 2.0 ppm; and nuts, tree, group 14-12 at 0.1 ppm. Per the Federal
Register of October 10, 2007 (72 FR 57492) (FRL-8149-9) supported by
Data Package (DP)  325387, August 9, 2008, EPA has determined
adequate analytical methods are available for enforcement purposes for
spinetoram in plant and animal matrices. For more details on the
analytical methods and for specific GRMs, see EPA Memorandum--
``Subject: Spinosad and Spinetoram; Human-Health Assessment Scoping
Document in Support of Registration Review'' dated August 9, 2011
(Decision  446932). EPA conservatively concluded that for
water, residues should be estimated using the total spinetoram residue
method (EPA, DP  331741, September 20, 2007). (RD)
    4. PP 3E8204. (EPA-HQ-OPP-2013-0727). Interregional Research
Project Number 4 (IR-4), 500 College Road East,

Suite 201 W., Princeton, NJ 08540, requests to establish tolerances in
40 CFR part 180 for residues of the insecticide spinosad, a
fermentation product of Saccharopolyspora spinosa, consisting of two
related active ingredients: Spinosyn A (Factor A: CAS Registry No.
131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-manno-
pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2-
yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-
14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn
D (Factor D; CAS Registry No. 131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-
methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-
tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-
as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on the raw
agricultural commodities: Coffee, green bean at 0.2 ppm; coffee,
instant at 0.4 ppm; coffee, roasted bean at 0.4 ppm; cottonseed
subgroup 20C at 0.02 ppm; caneberry subgroup 13-07A at 0.7 ppm;
bushberry subgroup 13-07B, except lingonberry at 0.25 ppm; fruit,
small, vine climbing, except fuzzy kiwifruit subgroup 13-07F at 0.5
ppm; berry, low growing, subgroup 13-07G, except blueberry, lowbush,
and cranberry at 1.0 ppm; fruit, pome group 11-10 at 0.2 ppm;
vegetable, fruiting, group 8-10 at 0.4 ppm; fruit, citrus, group 10-10
at 0.3 ppm; fruit, stone, group 12-12 at 0.2 ppm; onion, bulb, subgroup
3-07A at 0.1 ppm; onion, green, subgroup 3-07B at 2.0 ppm; and nuts,
tree, group 14-12 at 0.1 ppm. EPA has determined adequate analytical
methods are available for enforcement purposes for spinosad in plant
and animal matrices. For more details on the analytical methods and for
specific GRMs, see EPA Memorandum--``Subject: Spinosad and Spinetoram;
Human-Health Assessment Scoping Document in Support of Registration
Review,'' dated August 9, 2011 (Decision  446932). EPA
conservatively concluded that for water, residues should be estimated
using the total spinosad residue method (EPA, Decision
316077, August 2, 2006). (RD)
    5. PP 2F8053 (Revised) (EPA-HQ-OPP-2013-0008). BASF Corporation, 26
Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528
submitted revisions to their initial pesticide petition 2F8139 to
establish tolerances in 40 CFR part 180 for residues of the herbicide
saflufenacil, its metabolites, and degradates, in or on various
commodities. Based on EPA's evaluation of the data supporting the
original petition, BASF Corporation revised the petition by proposing
tolerances for fish-freshwater finfish and fish-shellfish, crustacean;
at 0.01 parts per million (ppm). Compliance with the tolerance levels
is to be determined by measuring only saflufenacil, 2-chloro-5-[3,6-
dihydro-3-methyl-2,6-dioxo-4- (trifluoromethyl)-1(2H)-pyrimidinyl]-4-
fluoro-N-[[methyl(1-methylethyl)amino]sulfonyl]benzamide, in or on the
commodities. Adequate enforcement methodology (LC-MS/MS) methods D0603/
02 (plants) and L0073/01 (livestock)) is available to enforce the
tolerance expression. (RD)
    6. PP 3F8173. (EPA-HQ-OPP-2013-0445). ISK Biosciences Corporation,
7470 Auburn Road, Suite A, Concord, OH 44077, requests to establish a
tolerance in 40 CFR part 180 for residues of the herbicide
flazasulfuron, 1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-trifluoromethyl-2-
pyridylsulfonyl) urea, in or on tree nuts (Crop group 14-12) at 0.01
ppm. A practical analytical method for flazasulfuron using LC-MS/MS is
available for enforcement purposes. (RD)

Amended Tolerance

    1. PP 3E8201. (EPA-HQ-OPP-2013-0729). Interregional Research
Project Number 4 (IR-4), 500 College Road East, Suite 201 W.,
Princeton, NJ 08540, requests to remove the existing tolerance in 40
CFR 180.205(a) for residues of the desiccant, defoliant, and herbicide
paraquat dichloride, (1,1'-dimethyl-4,4'-bipyridinium-ion) derived from
application of the dichloride salt (calculated as the cation), in or on
potato at 0.5 ppm, upon establishment of the proposed tolerance for the
tuberous and corm vegetables subgroup (Crop subgroup 1C) at 0.5 ppm in
paragraph 1. under ``New Tolerance.'' (RD)
    2. PP 3E8203. (EPA-HQ-OPP-2013-0730). Interregional Research
Project Number 4 (IR-4), 500 College Road East, Suite 201 W.,
Princeton, NJ 08540, proposes based upon the establishment of
tolerances in paragraph 3. under ``New Tolerance'' to remove
established tolerances at 40 CFR 180.635 for the combined residues of
the insecticide spinetoram, expressed as a combination of XDE-175-J: 1-
H-as-indaceno[3,2-d] oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-
2,4-di-O-methyl-a-L-manno pyranosyl)oxy]-13-[[(2R,5S,6R)-5-
(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro 14-methyl-
,(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR); XDE-175-L: 1H-as-indaceno[3,2-
d] oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-a-
L-manno pyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-
methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-,
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS); ND-
J:(2R,3aR,5aR,5bS,9S,13S,14R,16aS, 16bR)-9-ethyl-14-methyl-13-
[[(2S,5S,6R)-6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-
7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-2-yl 6-deoxy-3-O-
ethyl-2,4-di-O-methyl-alpha-L-mannopyranoside; and NF-J: (2R,3S,6S)-6-
([(2R,3aR,5aR,5bS,9S,13S, 4R,16aS,16bR)-2-[(6-deoxy-3-O-ethyl-2,4-di-O-
methyl-alpha-L-mannopyranosyl) oxy]-9-ethyl-14-methyl-7,15-dioxo-
2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-as-
indaceno[3,2-d]oxacyclododecin-13-yl]oxy)-2-methyltetrahydro-2H-pyran-
3-yl(methyl)formamide, in or on the following raw agricultural
commodities: Bushberry subgroup 13B at 0.25 ppm; caneberry subgroup 13A
at 0.70 ppm; fruit, citrus, group 10 at 0.30 ppm; fruit, pome, group 11
at 0.20 ppm; fruit, stone, group 12 at 0.20 ppm; grape at 0.50 ppm;
juneberry at 0.25 ppm; lingonberry at 0.25 ppm; nut tree, group 14 at
0.10 ppm; okra at 0.40 ppm; onion, green at 2.0 ppm; pistachio at 0.10
ppm; salal at 0.25 ppm; strawberry at 1.0 ppm; vegetable, bulb, group
3, except green onion at 0.10 ppm; vegetable, fruiting group 8 at 0.4
ppm; and cotton, undelinted seed at 0.04 ppm. (RD)
    3. PP 3E8204. (EPA-HQ-OPP-2013-0727). Interregional Research
Project Number 4 (IR-4), 500 College Road East, Suite 201 W.,
Princeton, NJ 08540, proposes based upon the establishment of
tolerances in paragraph 4. under ``New Tolerance'' to remove
established tolerances at 40 CFR 180.495 for residues of the
insecticide spinosad, a fermentation product of Saccharopolyspora
spinosa, consisting of two related active ingredients: Spinosyn A
(Factor A: CAS Registry No. 131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-
methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-
tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D;
CAS Registry No. 131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-
[alpha]- L-manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-
methyl-2H-pyran-2-yl]oxy]-9-ethyl-

2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-
as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on the raw
agricultural commodities: Bushberry subgroup 13B at 0.25 ppm; caneberry
subgroup 13A at 0.70 ppm; fruit, citrus, group 10 at 0.30 ppm; fruit,
pome, group 11 at 0.20 ppm; fruit, stone, group 12 at 0.20 ppm; grape
at 0.50 ppm; juneberry at 0.25 ppm; lingonberry at 0.25 ppm; nut tree,
group 14 at 0.10 ppm; okra at 0.40 ppm; onion, green at 2.0 ppm;
pistachio at 0.10 ppm; salal at 0.25 ppm; strawberry at 1.0 ppm;
vegetable, bulb, group 3, except green onion at 0.10 ppm; vegetable,
fruiting group 8 at 0.4 ppm; and cotton, undelinted seed at 0.02 ppm.
(RD)

New Tolerance Exemption

    1. PP 3F8176. (EPA-HQ-OPP-2013-0717). Anatis Bioprotection, Inc.,
278, rang Saint-Andr[eacute], St-Jacques-le-Mineur, Quebec JOJ 1Z0,
Canada (represented by Technology Sciences Group, Inc., 712 Fifth St.,
Suite A, Davis CA 95616), requests to establish an exemption from the
requirement of a tolerance for residues of the microbial insecticide,
Beauveria bassiana strain ANT-03, in or on all food commodities. The
petitioner believes no analytical method is needed because their
expectation is that, when used as proposed, Beauveria bassiana strain
ANT-03 would not result in residues that are of toxicological concern.
(BPPD)
    2. PP IN-10604. (EPA-HQ-OPP-2013-0700). Gowan Company, LLC, P.O.
Box 5569, Yuma, AZ 85366 requests to establish an exemption from the
requirement of a tolerance for residues of ammonium acetate (CAS
Registry No. 631-61-8), under 40 CFR 180.920, when used at not more
than 15% of a pesticide formulation, as a preharvest inert ingredient
in or on raw agricultural commodities. The petitioner believes no
analytical method is needed because it is not required for the
establishment of a tolerance exemption for inert ingredients. Based on
the physical chemical characteristics of ammonium acetate, there is
little likelihood of foliar residues remaining on treated crops.
Ammonium acetate is highly soluble in water and undergoes rapid
environmental degradation in soil and water, breaking down into acetate
and ammonium. Acetate/acetic acid as such would not be expected to
remain on foliage and or bioaccumulate or persist in humans. Therefore,
analytical methods to assess residues of ammonium acetate are not
required. (RD)

List of Subjects in 40 CFR Part 180

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: December 20, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2013-31258 Filed 12-27-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: May 20, 2009 (Volume 74, Number 96)]
[Proposed Rules]
[Page 23668-23671]
[DOCID:fr20my09-24]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0464; Directorate Identifier 2008-NM-189-AD]
RIN 2120-AA64

Airworthiness Directives; Short Brothers Model SD3-60 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above that would revise an existing AD. This proposed
AD results from mandatory continuing airworthiness information (MCAI)
originated by an aviation authority of another country to identify and
correct an unsafe condition on an aviation product. The MCAI describes
the unsafe condition as:

    There have been several occurrences of cracked elevator trim tab
balance weight attachment brackets. On one occasion, the elevator
trim tab mass balance weight bracket separated from the aircraft.
The loss of an elevator trim tab mass balance weight bracket has the
potential to cause damage to an aircraft, or cause serious injury to
personnel. * * *

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

DATES: We must receive comments on this proposed AD by June 19, 2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Short Brothers PLC, Airworthiness, P.O. Box 241, Airport Road, Belfast
BT3 9DZ, Northern Ireland; telephone +44(0)2890-462469; fax +44(0)2890-
468444; e-mail<EMAIL_ADDRESS>Internet http://
www.bombardier.com.
    You may review copies of the referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Todd Thompson, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1175; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2009-0464;
Directorate Identifier 2008-NM-189-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On July 23, 2008, we issued AD 2008-16-09, amendment 39-15627 (73
FR 46543, August 11, 2008). That AD required actions intended to
address an unsafe condition on the products listed above.
    Since we issued AD 2008-16-09, Short Brothers advised that SD3-07-
6011xA brackets manufactured in 2005 or later have a life limit of
28,800 flight hours, per Section 5-00-02 of the Short Brothers SD360
Aircraft Maintenance Manual (AMM), and as noted in Appendix 1 of Shorts
Alert Service Bulletin SD360-55-A21, Revision 1, dated March 29, 2007.
In light of this, we have revised the existing AD to propose extending
the life limit of any balance weight bracket from 1,750 flight hours to
28,800 flight hours. You may obtain further information by examining
the MCAI in the AD docket.
    In addition, we removed paragraphs (f) and (l)(1) of the existing
AD from this proposed AD. Those paragraphs define the use of the term
``service bulletin,'' as used in the AD.

Relevant Service Information

    Shorts has issued Service Bulletin SD360-55-20, Revision 2, dated
March 29, 2007. The actions described in this service information are
intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

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

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 21 products of U.S. registry. We also estimate that
it would take about 8 to 12 work-hours per product to comply with the
basic requirements of this proposed AD. The average labor rate is $80
per work-hour. Required parts would cost about $632 to $864 per
product. Where the service information lists required parts costs that
are covered under warranty, we have assumed that there will be no
charge for these costs. As we do not control warranty coverage for
affected parties, some parties may incur costs higher than estimated
here. Based on these figures, we estimate the cost of the proposed AD
on U.S. operators to be $26,712 to $38,304, or $1,272 to $1,824 per
product.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, 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

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

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

Sec.  39.13   [Amended]

    2. The FAA amends Sec.  39.13 by removing Amendment 39-15627 (73 FR
46543, August 11, 2008) and adding the following new AD:

Short Brothers PLC: Docket No. FAA-2009-0464; Directorate Identifier
2008-NM-189-AD.

Comments Due Date

    (a) We must receive comments by June 19, 2009.

Affected ADs

    (b) The proposed AD revises AD 2008-16-09, Amendment 39-15627.

Applicability

    (c) This AD applies to all Shorts Model SD3-60 airplanes,
certificated in any category.

Subject

    (d) Air Transport Association (ATA) of America Code 55:
Stabilizers.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
(i.e., EASA Airworthiness Directive 2007-0107-E, dated April 18,
2007) states:

There have been several occurrences of cracked elevator trim tab
balance weight attachment brackets. On one occasion, the elevator
trim tab mass balance weight bracket separated from the aircraft.
The loss of an elevator trim tab mass balance weight bracket has the
potential to cause damage to an aircraft, or cause serious injury to
personnel. * * *
* * * * *

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Restatement of Requirements of AD 2004-13-08, Amendment 39-13690

Initial Inspection

    (g) Within 2 months after August 3, 2004 (the effective date of
AD 2004-13-08, amendment 39-13690): Do a dye penetrant inspection
for cracking in the welded joints of the balance weight brackets for
the left and right elevator trim tabs, in accordance with the
Accomplishment Instructions of Short Brothers Service Bulletin
SD360-55-20, dated June 26, 2003; Shorts Service Bulletin SD360-55-
20, Revision 1, dated June 20, 2005; or Shorts Service Bulletin
SD360-55-20, Revision 2, dated March 29, 2007.

Investigative and Corrective Actions if No Cracking Is Found

    (h) If no cracking is found during the inspection required by
paragraph (g) of this AD, do the actions required by paragraphs
(h)(1) and (h)(2) of this AD at the applicable compliance times.
    (1) Repeat the inspection required by paragraph (g) of this AD
at intervals not to

exceed 4,800 flight hours until the bracket is replaced per
paragraph (h)(2) or (i) of this AD.
    (2) Prior to the accumulation of 28,800 total flight hours, or
within 6 months after August 3, 2004, whichever occurs later:
Replace any bracket that has not been replaced per paragraph (i) of
this AD with a new bracket or with a serviceable bracket that has
been inspected in accordance with paragraph (g) of this AD. Replace
in accordance with the Accomplishment Instructions of Short Brothers
Service Bulletin SD360-55-20, dated June 26, 2003; Shorts Service
Bulletin SD360-55-20, Revision 1, dated June 20, 2005; or Shorts
Service Bulletin SD360-55-20, Revision 2, dated March 29, 2007.
Replacement of the brackets constitutes terminating action for the
repetitive inspections required by paragraph (h)(1) of this AD.

Corrective Actions if Any Cracking Is Found

    (i) If any cracking is found during any inspection required by
paragraph (g) or (h) of this AD: Before further flight, accomplish
the applicable action in paragraph (i)(1) or (i)(2) of this AD in
accordance with the Accomplishment Instructions of Short Brothers
Service Bulletin SD360-55-20, dated June 26, 2003; Shorts Service
Bulletin SD360-55-20, Revision 1, dated June 20, 2005; or Shorts
Service Bulletin SD360-55-20, Revision 2, dated March 29, 2007.
    (1) For airplanes that have accumulated less than 28,800 flight
hours and on which all cracking on brackets is less than 0.25 inch
in length: Repair the affected bracket in accordance with Part B of
the Accomplishment Instructions of Short Brothers Service Bulletin
SD360-55-20, dated June 26, 2003; Shorts Service Bulletin SD360-55-
20, Revision 1, dated June 20, 2005; or Shorts Service Bulletin
SD360-55-20, Revision 2, dated March 29, 2007 (including the
additional dye penetrant inspection of the repaired welded joint);
and repeat the inspection required by paragraph (g) of this AD at
intervals not to exceed 4,800 flight hours; or replace the bracket
in accordance with paragraph (h)(2) of this AD. Replacement of the
bracket constitutes terminating action for the repetitive
inspections.
    (2) For any airplane on which any cracking on a bracket is 0.25
inch in length or greater, and for any airplane that has accumulated
28,800 flight hours or more on which any cracking of any length is
found on a bracket: Replace the affected bracket with a new bracket
or with a serviceable bracket that has been inspected in accordance
with paragraph (g) of this AD. Replacement of the bracket
constitutes terminating action for the repetitive inspections
required by paragraph (i)(1) of this AD.

Refitting

    (j) Before further flight following any inspection per paragraph
(g) or (h) of this AD; or before further flight following repair or
replacement of a bracket per paragraph (h)(2) or (i) of this AD:
Refit the balance weights, covers, and trim tabs, in accordance with
the Accomplishment Instructions of Short Brothers Service Bulletin
SD360-55-20, dated June 26, 2003; Shorts Service Bulletin SD360-55-
20, Revision 1, dated June 20, 2005; or Shorts Service Bulletin
SD360-55-20, Revision 2, dated March 29, 2007. Where the
Accomplishment Instructions of Short Brothers Service Bulletin
SD360-55-20, dated June 26, 2003; Shorts Service Bulletin SD360-55-
20, Revision 1, dated June 20, 2005; or Shorts Service Bulletin
SD360-55-20, Revision 2, dated March 29, 2007; specify to contact
the manufacturer for disposition of certain conditions while
refitting, obtain further disposition instructions from the Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA;
or the European Aviation Safety Agency (EASA) (or its delegated
agent).

Parts Installation

    (k) As of August 3, 2004, no person may install on any airplane
a balance weight bracket unless the welded joint has been inspected
in accordance with paragraph (g) of this AD.

Restatement of Requirements of AD 2005-04-13, Amendment 39-13985

Return of Parts to Manufacturer Not Required

    (l) Although the Accomplishment Instructions of Short Brothers
Alert Service Bulletin SD360-55-A21, dated December 16, 2004; or
Shorts Alert Service Bulletin SD360-55-A21, Revision 1, dated March
29, 2007; specify to return subject parts to the manufacturer, this
AD does not include that requirement.

Repetitive Inspections

    (m) For airplanes equipped with balance weight brackets of the
elevator trim tabs having part number SD3-07-6011xA, and having a
serial number beginning with ``X3'' or ``X4'': Prior to the
accumulation of 250 flight hours since installation of the subject
balance weight bracket of the elevator trim tab, or within 30 flight
hours after March 14, 2005 (the effective date of AD 2005-04-13),
whichever is later, do a dye penetrant inspection for cracking of
the balance weight brackets for the left and right elevator trim
tabs, in accordance with Short Brothers Alert Service Bulletin
SD360-55-A21, dated December 16, 2004; or Shorts Alert Service
Bulletin SD360-55-A21, Revision 1, dated March 29, 2007.
    (1) For a balance weight bracket on which no cracking is found:
Do paragraph (o) of this AD, and repeat the inspection thereafter at
intervals not to exceed 250 flight hours until paragraph (m) of this
AD is accomplished.
    (2) For a balance weight bracket on which any cracking is found:
Before further flight, replace the bracket with a new or reworked
balance weight bracket that conforms to the approved design
standard, in accordance with Short Brothers Alert Service Bulletin
SD360-55-A21, dated December 16, 2004; or Shorts Alert Service
Bulletin SD360-55-A21, Revision 1, dated March 29, 2007; and do
paragraph (o) of this AD.

Optional Terminating Action

    (n) For airplanes equipped with balance weight brackets of the
elevator trim tabs having part number SD3-07-6011xA, and having a
serial number beginning with ``X3'' or ``X4'': Replacement of any
subject balance weight bracket with a new or reworked balance weight
bracket that conforms to the approved design standard, in accordance
with the Accomplishment Instructions of Short Brothers Alert Service
Bulletin SD360-55-A21, dated December 16, 2004; or Shorts Alert
Service Bulletin SD360-55-A21, Revision 1, dated March 29, 2007;
constitutes terminating action for the repetitive inspections
required by paragraph (m) of this AD for the replaced bracket.

Refitting

    (o) For airplanes equipped with balance weight brackets of the
elevator trim tabs having part number SD3-07-6011xA, and having a
serial number beginning with ``X3'' or ``X4:'' Before further flight
following any inspection or replacement of a bracket in accordance
with paragraphs (m) and (n) of this AD: Refit the balance weights,
covers, and trim tabs, in accordance with the Accomplishment
Instructions of Short Brothers Alert Service Bulletin SD360-55-A21,
dated December 16, 2004; or Shorts Alert Service Bulletin SD360-55-
A21, Revision 1, dated March 29, 2007. Where the Accomplishment
Instructions of Short Brothers Alert Service Bulletin SD360-55-A21,
dated December 16, 2004; or Shorts Alert Service Bulletin SD360-55-
A21, Revision 1, dated March 29, 2007; specify to contact the
manufacturer for disposition of certain conditions while refitting,
obtain further disposition instructions from the Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA;
or the European Aviation Safety Agency (EASA) (or its delegated
agent).

Parts Installation

    (p) For all airplanes: As of March 14, 2005, no person may
install, on any airplane subject to this AD, a balance weight
bracket having part number SD3-07-6011xA, and having a serial number
beginning with ``X3'' or ``X4,'' unless the bracket is also marked
``Rework batch number R-Bxxxxx'' (where ``xxxxx'' is a number).

Restatement of Requirements of AD 2008-16-09, Amendment 39-15627, With
Extended Repetitive Interval in Paragraph (q)(2)

Inspection(s) and Replacements

    (q) For airplanes equipped with balance weight brackets of the
elevator trim tabs having part number SD3-07-6011xA manufactured in
the year 2003 or 2004, including reworked brackets, installed in
accordance with paragraph (h)(2), (i)(2), or (n) of this AD, as
applicable: Do the actions specified in paragraphs (q)(1) and (q)(2)
of this AD in accordance with Parts A and B of the Accomplishment
Instructions of Shorts Alert Service Bulletin SD360-55-A21, Revision
1, dated March 29, 2007.
    (1) Within 30 flight hours after September 15, 2008 (the
effective date of AD 2008-16-09) or within 250 flight hours since
installation of the balance weight brackets of the elevator trim
tabs or since the last inspection required by paragraph (g), (h)(1),
(i)(1), or (m) of this AD, whichever occurs

later: Do a dye penetrant inspection to detect cracks of the balance
weight brackets of the elevator trim tabs.
    (i) If no crack is detected, repeat the dye penetrant inspection
at intervals not to exceed 250 flight hours, until the replacement
required by paragraph (q)(2) of this AD is done.
    (ii) If any crack is detected, before further flight, do the
replacement specified in paragraph (q)(2) of this AD.
    (2) Before the accumulation of 1,750 flight hours since
installation of the balance weight brackets of the elevator trim
tabs, or within 180 days after September 15, 2008, whichever occurs
later: Replace the balance weight brackets with new balance weight
brackets manufactured in 2005 or later. Thereafter, replace any
balance weight bracket with a new bracket manufactured in 2005 or
later at intervals not to exceed the accumulation of 28,800 flight
hours on that bracket. Accomplishment of the initial replacement
ends the repetitive inspection requirements of this AD.
    (r) For airplanes equipped with balance weight brackets of the
elevator trim tabs having part number SD3-31-6213xB inspected in
accordance with paragraph (g), (h)(1), or (i)(1) of this AD and
retained or refitted following approved repair in accordance with
paragraph (j) of this AD: Do the actions specified in paragraphs
(r)(1) and (r)(2) of this AD in accordance with Parts A and B of the
Accomplishment Instructions of Shorts Alert Service Bulletin SD360-
55-20, Revision 2, dated March 29, 2007.
    (1) Within 4,800 flight hours since last inspection, or within
180 days after September 15, 2008, whichever occurs later, and
thereafter at intervals not to exceed 4,800 flight hours: Do a dye
penetrant inspection to detect cracks of the balance weight brackets
of the elevator trim tabs.
    (i) If no crack is detected, repeat the dye penetrant inspection
at intervals not to exceed 4,800 flight hours, until the replacement
required by paragraph (r)(2) of this AD is done.
    (ii) If any crack is detected, before further flight, do the
replacement specified in paragraph (r)(2) of this AD.
    (2) Before the accumulation of 28,800 flight hours since any
balance weight bracket of the elevator trim tabs is new, or within
180 days after September 15, 2008, whichever occurs later: Replace
the balance weight brackets with new balance weight brackets
manufactured in 2005 or later. Thereafter, replace any balance
weight bracket with a new bracket manufactured in 2005 or later at
intervals not to exceed the accumulation of 28,800 flight hours on
that bracket. Accomplishment of the initial replacement ends the
repetitive inspection requirements of this AD.

Part Installation

    (s) For all airplanes: As of September 15, 2008, no person may
install, on any airplane, a balance weight bracket of the elevator
trim tab manufactured earlier than 2005.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows: No Differences.

Other FAA AD Provisions

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

Related Information

    (u) Refer to MCAI EASA Airworthiness Directive 2007-0107-E,
dated April 18, 2007, and the service bulletins identified in Table
1 of this AD for related information.

                                      Table 1--Related Service Information
----------------------------------------------------------------------------------------------------------------
                    Document                        Revision                           Date
----------------------------------------------------------------------------------------------------------------
Short Brothers Alert Service Bulletin SD360-55-        Original  December 16, 2004.
 A21.
Short Brothers Service Bulletin SD360-55-20....        Original  June 26, 2003.
Shorts Alert Service Bulletin SD360-55-A21.....               1  March 29, 2007.
Shorts Service Bulletin SD360-55-20............               1  June 20, 2005.
Shorts Service Bulletin SD360-55-20............               2  March 29, 2007.
----------------------------------------------------------------------------------------------------------------

    Issued in Renton, WA, on May 11, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-11709 Filed 5-19-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)]
[Notices]
[Pages 7837-7839]
[FR Doc No: 2017-01249]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-P-0377]

Determination That ACTHAR GEL SYNTHETIC (Seractide Acetate)
Injection, 80 Units/Milliliter and 40 Units/Milliliter, Was Withdrawn
From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) has determined
that ACTHAR GEL SYNTHETIC (seractide acetate) injection, 80 units/
milliliter (mL) and 40 units/mL, was withdrawn from sale for reasons of
safety or effectiveness. The Agency will not accept or approve
abbreviated new drug applications (ANDAs) for seractide acetate
injection, 80 units/mL and 40 units/mL.

FOR FURTHER INFORMATION CONTACT: David E. Markert, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-
796-0752.

SUPPLEMENTARY INFORMATION:

I. Background

    In 1984, Congress enacted the Drug Price Competition and Patent
Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments),
which authorized the approval of duplicate versions of drug products
under an ANDA procedure. ANDA applicants must, with certain exceptions,
show that the drug for which they are seeking approval contains the
same active ingredient in the same strength and dosage form as the
``listed drug,'' which is a version of the drug that was previously
approved. ANDA applicants do not have to repeat the extensive clinical
testing otherwise necessary to gain approval of a new drug application
(NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (21 CFR 314.161). FDA may not approve an ANDA that does not refer
to a listed drug.
    ACTHAR GEL SYNTHETIC (seractide acetate) injection, 80 units/mL and
40 units/mL was the subject of NDA 017861, which was held by Armour
Pharmaceutical Co. (Armour), and initially approved on February 21,
1978. ACTHAR GEL SYNTHETIC is indicated for diagnostic testing of
adrenocortical function. The labeling also provides that ACTHAR GEL
SYNTHETIC may be employed in the following disorders:
    Endocrine Disorders: Nonsuppurative thyroiditis; Hypercalcemia
associated with cancer.
    Nervous System Diseases: Acute exacerbations of multiple sclerosis.
    Rheumatic Disorders: As adjunctive therapy for short-term
administration (to tide the patient over an acute episode or
exacerbation) in: Psoriatic arthritis; rheumatoid arthritis, including
juvenile

rheumatoid arthritis (selected cases may require low-dose maintenance
therapy); ankylosing spondylitis; acute and subacute bursitis; acute
non-specific tenosynovitis; acute gouty arthritis; post-traumatic
arthritis; synovitis of osteoarthritis; epicondylitis.
    Collagen Diseases: During an exacerbation or as maintenance therapy
in selected cases of: Systemic lupus erythematosus; systemic
dermatomyositis (polymyositis); acute rheumatic carditis.
    Dermatologic Diseases: Pemphigus; bullous dermatitis herpetiformis;
severe erythema multiforme (Stevens-Johnson syndrome); exfoliative
dermatitis; severe psoriasis; severe seborrheic dermatitis; mycosis
fungoides.
    Allergic States: Control of severe or incapacitating allergic
conditions intractable to adequate trials of conventional treatment--
seasonal or perennial allergic rhinitis; bronchial asthma; contact
dermatitis; atopic dermatitis; serum sickness.
    Ophthalmic Diseases: Severe acute and chronic allergic and
inflammatory processes involving the eye and its adnexa such as:
Allergic conjunctivitis; keratitis; herpes zoster ophthalmicus; iritis
and iridocyclitis; diffuse posterior uveitis and choroiditis; optic
neuritis; sympathetic ophthalmia; chorioretinitis; anterior segment
inflammation; allergic corneal marginal ulcers.
    Respiratory Diseases: Symptomatic sarcoidosis; Loeffler's syndrome
not manageable by other means; berylliosis; fulminating or disseminated
pulmonary tuberculosis when used concurrently with anti-tuberculous
chemotherapy; aspiration pneumonitis.
    Hematologic Disorders: Acquired (autoimmune) hemolytic anemia;
secondary thrombocytopenia in adults; erythroblastopenia (RBC anemia);
congenital (erythroid) hypoplastic anemia.
    Neoplastic Diseases: For palliative management of: Leukemias and
lymphomas in adults; acute leukemia of childhood.
    Edematous State: To induce a diuresis or a remission of proteinuria
in the nephrotic syndrome without uremia of the idiopathic type or that
due to lupus erythematosus.
    Gastrointestinal Diseases: To tide the patient over a critical
period of the disease in: Ulcerative colitis; regional enteritis.
    Miscellaneous: Tuberculous meningitis with subarachnoid block or
impending block when concurrently accompanied by appropriate anti-
tuberculous chemotherapy; trichinosis with neurologic or myocardial
involvement.
    Armour never marketed ACTHAR GEL SYNTHETIC (seractide acetate)
injection, 80 units/mL and 40 units/mL. In previous instances (see,
e.g., 72 FR 9763, March 5, 2007 and 61 FR 25497, May 21, 1996), the
Agency has determined that for purposes of Sec. Sec.  314.161 and
314.162, never marketing an approved drug product is equivalent to
withdrawing the drug from sale. FDA withdrew approval of the NDA for
ACTHAR GEL SYNTHETIC in 2014 because Armour had repeatedly failed to
file annual reports for the application (79 FR 68454, November 17,
2014).
    Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated
April 1, 2014 (Docket No. FDA-2014-P-0377), under 21 CFR 10.30,
requesting that the Agency determine whether ACTHAR GEL SYNTHETIC
(seractide acetate) injection, 80 units/mL and 40 units/mL, was
withdrawn from sale for reasons of safety or effectiveness.

II. Response to Citizen Petition

    We have carefully reviewed the citizen petition (and comments
submitted to the docket); our records for ACTHAR GEL SYNTHETIC
(seractide acetate) injection, 80 units/mL and 40 units/mL; the
scientific literature on seractide acetate; and other relevant
information. Based on that review, and for the reasons set forth in
this section, we have concluded that additional studies of safety would
be necessary before ACTHAR GEL SYNTHETIC could be considered for
introduction to the market today. Consequently, FDA has determined
under Sec.  314.161 that ACTHAR GEL SYNTHETIC (seractide acetate)
injection, 80 units/mL and 40 units/mL, was withdrawn for reasons of
safety.\1\
---------------------------------------------------------------------------

    \1\ In light of this conclusion, it is unnecessary for us to
determine whether ACTHAR GEL SYNTHETIC was also withdrawn from sale
for reasons of effectiveness. This notice does not address the
effectiveness of ACTHAR GEL SYNTHETIC for its labeled indications.
---------------------------------------------------------------------------

    The labeling for ACTHAR GEL SYNTHETIC describes the product as ``a
highly purified synthetic polypeptide containing thirty-nine amino
acids in the sequence described for human corticotropin by Lee, T.H.;
Lerner, A.B.; and Buettner-Janusch, Vina (J. Biol Chem, 236:2970-2974,
Nov. 1961)'' (Refs. 1 and 2). At the time of ACTHAR GEL SYNTHETIC's
approval, FDA believed the amino acid sequence described by Lee et al.
was the correct sequence for human corticotropin and, therefore, that
ACTHAR GEL SYNTHETIC was identical to human corticotropin.\2\ However,
since approval, the Agency has learned that ACTHAR GEL SYNTHETIC is not
identical to the human corticotropin sequence. We now know that the
amino acid sequence described by Lee et al. is a deamidated version of
human corticotropin that differs from full length human corticotropin
at four positions.\3\
---------------------------------------------------------------------------

    \2\ The Agency's Institutional Summary of Basis of Approval
(Ref. 3) describes ACTHAR GEL SYNTHETIC as ``a synthetic peptide of
39 amino acids identical with that of natural human'' corticotropin.
    \3\ The record for human pro-opiomelanocortin preproprotein in
the National Center for Biotechnology Information's ``Protein''
database (Reference Sequence NP_000930.1) contains the correct amino
acid sequence for human corticotropin. The record is available at
the following URL: https://www.ncbi.nlm.nih.gov/protein/NP_000930.1.
The sequence described by Lee et al. differs from the correct
sequence at positions 25-27 and 30.
---------------------------------------------------------------------------

    The fact that ACTHAR GEL SYNTHETIC has a different amino acid
sequence from human corticotropin raises significant safety concerns.
Due to its different amino acid sequence, ACTHAR GEL SYNTHETIC might
have a structure or function that is not recognized as endogenous by
the immune system. ACTHAR GEL SYNTHETIC thus poses a higher risk of
immunogenicity than a synthetic peptide product that is, in fact,
identical to human corticotropin. The health consequences of
immunogenicity range from subacute, minor reactions to severe, even
deadly, reactions (e.g., anaphylaxis). In addition, frequent
stimulation of the immune system could produce antibodies that cross-
react with human corticotropin and other closely related endogenous
peptides, resulting in the loss of those peptides' physiological
functions. Such an effect could last long after treatment with ACTHAR
GEL SYNTHETIC has stopped.
    The safety concerns noted in this section have not been adequately
investigated. ACTHAR GEL SYNTHETIC was studied in two clinical trials
in 51 healthy adult men between 21 and 54 years old. Although no
unusual adverse effects were reported during these trials, the trials
did not assess the impact of immunogenicity on safety. Nor were they
designed to assess immunogenicity. Moreover, because ACTHAR GEL
SYNTHETIC was never marketed, the Agency has no postmarketing safety
data or information confirming that the product is safe for human use,
notwithstanding the differences between ACTHAR GEL SYNTHETIC's amino
acid sequence and that of human corticotropin. Given the lack of any
premarket or postmarket

immunogenicity safety data, FDA cannot conclude that ACTHAR GEL
SYNTHETIC would be safe for human use if it were introduced to the
market today.
    Accordingly, the Agency will remove ACTHAR GEL SYNTHETIC (seractide
acetate) injection, 80 units/mL and 40 units/mL, from the list of drug
products published in the Orange Book. FDA will not accept or approve
ANDAs that refer to this drug product.

III. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they are also available electronically at https://www.regulations.gov.

1. Armour Pharmaceutical Co., ``ACTHAR[supreg] Gel Synthetic
(SERACTIDE ACETATE), Synthetic Corticotropin,'' Product Labeling,
1979.
2. Lee, T. H., A. B. Lerner, and V. Buettner-Janusch, ``On the
Structure of Human Corticotropin (Adrenocorticotropic Hormone),''
The Journal of Biological Chemistry, vol. 236, pp. 2970-2974, 1961.
3. FDA, ``Seractide Acetate: Institutional Summary of Basis of
Approval,'' August 22, 1977.

    Dated: January 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-01249 Filed 1-19-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 236 (Thursday, December 8, 2011)]
[Notices]
[Pages 76785-76786]
[FR Doc No: 2011-31482]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65874; File No. SR-C2-2011-037]

Self-Regulatory Organizations; C2 Options Exchange, Incorporated;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Amend the Fees Schedule

 December 2, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on November 23, 2011, the Chicago Board Options Exchange,
Incorporated [sic] (the ``Exchange'' or ``C2'') filed with the
Securities and Exchange Commission (the ``Commission'') the proposed
rule change as described in Items I, II, and III below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its Fees Schedule. The text of the
proposed rule change is available on the Exchange's Web site (http://www.cboe.org/legal), at the Exchange's Office of the Secretary, and at
the Commission.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of and basis for the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    On September 2, 2011, the Commission approved a proposed rule
change filed by the Exchange to permit on a pilot basis the listing and
trading on C2 of Standard & Poor's 500 Index (``S&P 500'') options with
third-Friday-of-the-month (``Expiration Friday'') expiration dates for
which the exercise settlement value will be based on the index value
derived from the closing prices of component securities (``SPXPM'').\3\
On September 28, 2011, the Exchange filed an immediately-effective rule
change to adopt fees associated with the anticipated trading of SPXPM
(the ``Initial SPXPM Fees Filing'').\4\ The Exchange now proposes to
amend those fees associated with the trading of SPXPM.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 34-65256 (September
2, 2011), 76 FR 55969 (September 9, 2011) (SR-C2-2011-008).
    \4\ See Securities Exchange Act Release No. 34-65471 (October 3,
2011), 76 FR 62491 (October 7, 2011) (SR-C2-2011-026).
---------------------------------------------------------------------------

    In the Initial SPXPM Fees Filing, the Exchange adopted an SPXPM
Tier Appointment Fee of $4,000 which would be charged to any Market-
Maker Permit holder that has an appointment (registration) in SPXPM at
any time during a calendar month, but the Exchange also waived that fee
through November 30, 2011. The Exchange hereby proposes continuing that
waiver for the month of December 2011. The purpose of this waiver
extension is to allow more time for the SPXPM market to develop and
allow and encourage Market-Makers to join in and elect for an SPXPM
Tier Appointment.
    The Exchange also proposes to cease charging no transaction fee for
SPXPM Trades on the Open (trades which occur upon the opening of
trading). The Exchange did not intend to waive transaction fees for
SPXPM Trades on the Open, and such waiver was unintentionally included
in the Initial SPXPM Fees Filing. While the Exchange waives transaction
fees for Trades on the Open in multiply-listed classes, the rationale
for such a waiver does not apply to SPXPM Trades on the Open. C2
multiply-listed options classes are traded using a Maker-Taker pricing
model in which orders that take liquidity from the marketplace are
charged a transaction fee and orders that provide liquidity to the
market place receive a rebate. For this model, C2 is unable to charge
for Trades on the Open because it is not possible to identify who is
the Maker and who is the Taker. SPXPM utilizes a pricing model in which
transactions fees are charged to Market-Makers, Professionals and
customers, so differentiating Trades on the Open is not an issue and
therefore such trades should be treated similarly to all other SPXPM
transactions. Henceforth, transaction fees for SPXPM Trades on the Open
will be assessed in the same manner as they are assessed for normal
SPXPM transactions.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\5\ in general, and furthers the objectives of Section 6(b)(4) \6\
of the Act in particular, in that it is designed to provide for the
equitable allocation of reasonable dues, fees, and other charges among
C2 Trading Permit Holders and other persons using Exchange facilities.
Continuing the waiver of the SPXPM Tier Appointment Fee is reasonable
because it will allow Market-Makers with an SPXPM Tier Appointment to
avoid paying the Tier Appointment Fee for another month, and is
equitable and not unfairly discriminatory because all Market-Makers
with an SPXPM Tier Appointment will be able to avoid paying the SPXPM
Tier Appointment Fee for December 2011. Assessing transaction fees for
SPXPM Trades on the Open is reasonable because the amount of the
transaction fees will be the same as the amount of SPXPM transaction
fees assessed during the rest of the trading day. Assessing transaction
fees for SPXPM Trades on the Open is equitable and not unfairly
discriminatory because the fees will be assessed equally to all parties
within each class who qualify for the fees, just as they are during the
rest of the trading day.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    C2 does not believe that the proposed rule change will impose any
burden on competition not necessary or appropriate in furtherance of
the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The proposed rule change is designated by the Exchange as
establishing or changing a due, fee, or other charge, thereby
qualifying for effectiveness on filing pursuant to Section 19(b)(3)(A)
of the Act \7\ and subparagraph (f)(2) of Rule 19b-4 \8\ thereunder. At
any time within 60 days of the filing of the proposed rule change, the
Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-C2-2011-037 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-C2-2011-037. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro/shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing will also be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-C2-2011-037 and should be
submitted on or before December 29, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-31482 Filed 12-7-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: October 31, 2008 (Volume 73, Number 212)]
[Notices]
[Page 64941]
[DOCID:fr31oc08-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Project No. 2677-019]

City of Kaukauna, WI; Notice of Staff Participation in Meeting

October 23, 2008.
    On November 10, 2008, Office of Energy Projects Staff will
participate by teleconference in a work group meeting to discuss the
proposed scope of work for the IFIM-type study being conducted for the
relicensing of the Badger-Rapide Croche Hydroelectric Project (FERC No.
2677-019). The meeting will begin at 10 a.m. EST.
    Interested parties wishing to attend should contact Arie DeWaal,
Project Manager, Mead & Hunt, Inc., at<PHONE_NUMBER>, or via e-mail at
<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. E8-25973 Filed 10-30-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 97 (Monday, May 22, 2017)]
[Notices]
[Pages 23236-23237]
[FR Doc No: 2017-10383]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-437-000]

Texas Gas Transmission, LLC; Notice of Request Under Blanket
Authorization

    Take notice that on May 5, 2017, Texas gas Transmission, LLC (Texas
Gas), filed in Docket No. CP17-437-000 and pursuant to Sections 157.205
and 157.216 of the Commission's regulations, a prior notice under its
blanket certificate issued in Docket No. CP82-407-000 that it intends
to abandon certain natural gas pipeline assets and ancillary facilities
and appurtenances located in Terrebonne Parish, Louisiana, all as more
fully set forth in the application, which is on file with the
Commission and open to public inspection. The filing may also be viewed
on the Web at http://www.ferc.gov using the ``eLibrary'' link. Enter
the docket number excluding the last three digits in the docket number
field to access the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Texas Gas proposes to (i) abandon in place approximately 4.4 miles
and abandon by removal 2.4 miles of 8-inch pipeline designated as the
Calliou Bay--Dog Lake (CBD) Pipeline, (ii) abandon in place
approximately 10.1 miles and abandon by removal 1.7 miles of 10-inch
pipeline designated as the Deep Saline--Peltex (DST) Pipeline, and
(iii) abandon by removal two platforms including associated boat
landings, tube turns, including risers, meter facilities, associated
piping, and other auxiliary appurtenances (collectively Facilities), as
described more fully herein. These Facilities have been inactive since
December 2005 and abandonment avoids the ongoing maintenance costs of
unused existing natural gas pipeline assets. Texas Gas avers that the
proposed abandonment will not result in a material decrease in service
to customers.
    Any questions regarding this application should be directed to
Alice

A. Curtiss, Deputy General Counsel for National Fuel, 6363 Main Street,
Williamsville, New York 14221, or call at<PHONE_NUMBER>.
    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the Natural Gas Act (NGA) (18 CFR 157.205) file a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for protest. If a protest is filed and not
withdrawn within 30 days after the time allowed for filing a protest,
the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenter's will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenter's will not be required to serve copies of filed
documents on all other parties. However, the non-party commentary, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the ``e-Filing'' link. Persons unable to file
electronically should submit original and 5 copies of the protest or
intervention to the Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426.

    Dated: May 15, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-10383 Filed 5-19-17; 8:45 am]
 BILLING CODE 6717-01-P