[Federal Register Volume 77, Number 65 (Wednesday, April 4, 2012)]
[Proposed Rules]
[Pages 20334-20337]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8095]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 174 and 180
[EPA-HQ-OPP-2012-0001; FRL-9340-4]
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 May 4, 2012.
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.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to the docket ID number and the
pesticide petition number of interest as shown in the body of this
document. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the
[[Page 20335]]
electronic docket at http://www.regulations.gov, or, if only available
in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: A contact person, with telephone
number and email address, is listed at the end of each pesticide
petition summary. You may also reach each contact person by mail at
Antimicrobials Division (7510P), or Biopesticides and Pollution
Prevention Division (7511P) or Registration Division (7505P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed 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 174 or 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 food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.
New Tolerances
1. PP 1E7869. (EPA-HQ-OPP-2012-0048). Syngenta Crop Protection,
P.O. Box 18300, Greensboro, NC 27409, requests to establish a tolerance
in 40 CFR part 180 for residues of the fungicide cyprodinil, 2-
pyrimidinamine, 4-cyclopropyl-6-methyl-N-phenyl-, in or on leafy
petioles subgroup 04B at 30 parts per million (ppm). Syngenta Crop
Protection, has developed and validated analytical methodology for
enforcement purposes. This method Syngenta Crop Protection Method AG-
631B, has passed an Agency petition method validation for several
commodities and is currently the enforcement method for cyprodinil.
Contact: Lisa Jones, (703) 308-9424, email address: jones.lisa@epa.gov.
2. PP 1E7870. (EPA-HQ-OPP-2012-0047). Syngenta Crop Protection,
P.O. Box 18300, Greensboro, NC 27409, requests to establish a tolerance
in 40 CFR part 180 for residues of the fungicide fludioxonil, 4-(2, 2-
difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile, in or on
leafy petioles subgroup 04B at 14 ppm. Syngenta Crop
[[Page 20336]]
Protection, has developed and validated the analytical method Syngenta
Crop Protection Method AG-597B for enforcement purposes and has also
passed an Agency petition method validation (PMV) for several
commodities. It is currently the enforcement method for fludioxonil and
has also been forwarded to the Food and Drug Administration (FDA) for
inclusion into Pesticide Analytical Manual Volume II (PAM II). Contact:
Lisa Jones, (703) 308-9424, email address: jones.lisa@epa.gov.
3. PP 1E7924. (EPA-HQ-OPP-2012-0038). Bayer CropScience, P.O. Box
12014, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709,
requests to establish import tolerances in 40 CFR part 180 for residues
of the insecticide spiromesifen, 2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate and its enol
metabolite; 4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-
en-2-one calculated as the parent compound equivalents, in or on
imported tea, dried and the processed commodity instant tea at 50 ppm.
Adequate analytical methodology using liquid chromatography/mass
spectrometry (LC/MS/MS) detection is available for enforcement
purposes. Contact: Jennifer Gaines, (703) 305-5967, email address:
gaines.jennifer@epa.gov.
4. PP 1E7945. (EPA-HQ-OPP-2012-0041). Syngenta Crop Protection,
LLC, P.O. Box 18300, Greensboro, NC 27419-8300, requests to establish
an import tolerance in 40 CFR part 180 for residues of the fungicide
azoxystrobin, methyl (E)-2-[2-[6-(2-cyanophenoxy)pyrimidin-4-
yloxy]phenyl]-3-methoxyacrylate and the Z isomer of azoxystrobin,
methyl (Z)-2-[2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]pheny1]-3-
methoxyacrylate, in or on ginseng extract (red ginseng extract and
ginseng extract) at 0.5 ppm. An adequate analytical method, gas
chromatography with nitrogen-phosphorus detection (GC/NPD) or in mobile
phase by high performance liquid chromatography with ultra-violet
detection (HPLC/UV) is available for enforcement purposes with a limit
of detection that allows monitoring of food with residues at or above
the levels set in these tolerances. Contact: Erin Malone, (703) 347-
0253, email address: malone.erin@epa.gov.
5. PP 1E7951. (EPA-HQ-OPP-2011-1011). 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 herbicide S-ethyl dipropylthiocarbamate (EPTC),
including its metabolites and degradates, determined by measuring only
the sum of S-ethyl dipropylthiocarbamate, S-ethyl (2-hydroxypropyl)
propylcarbamothioate, S-(2-hydroxyethyl)dipropylcarbamothioate, and S-
ethyl (3-hydroxypropyl)propylcarbamothioate, calculated as the
stoichiometric equivalent of S-ethyl dipropylthiocarbamate, in or on
fruit, citrus, group 10-10 at 0.1 ppm; sunflower subgroup 20B at 0.08
ppm; and watermelon at 0.08 ppm. Adequate methods are available for the
determination of EPTC and three hydroxy metabolites in crops, including
watermelon. EPTC is analyzed by extraction of the macerated samples
with toluene with subsequent quantification using GC/NPD. The three
hydroxy metabolites are extracted from macerated samples with a mixture
of acetone and water. The acetone is dispelled and the aqueous fraction
is digested with acid. The hydrolyzed metabolites are then extracted
with a mixture of hexane and ether, and the extract is purified through
a solid phase extraction cartridge. The residues are then derivatized
and quantified using a GC equipped with a mass-selective detector
(MSD). Contact: Sidney Jackson, (703) 305-7610, email address:
jackson.sidney@epa.gov.
6. PP 1E7957. (EPA-HQ-OPP-2012-0010). 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 herbicide quinclorac, 3,7-dichloro-8-
quinolinecarboxylic acid, including its metabolites and degradates
determined by measuring only quinclorac, in or on rhubarb at 0.4 ppm;
and berry, low growing, except strawberry, subgroup 13-07H at 1.1 ppm.
Adequate analytical methods, utilizing GC with electron capture
detection (GC/ECD), are available to enforce the tolerance expression
on plant (BASF Method A8902) and animal (BASF Method 268/1)
commodities. Both methods have undergone successful Agency method
validation trials, and have been submitted to the FDA for publication
in PAM II as the tolerance enforcement methods. Contact: Sidney
Jackson, (703) 305-7610, email address: jackson.sidney@epa.gov.
7. PP 1E7958. (EPA-HQ-OPP-2012-0107). 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 spirotetramat, cis-3-(2,5-dimethlyphenyl)-
8-methoxy-2-oxo-1-azaspiro[4.5]dec-3-en-4-yl-ethyl carbonate and its
metabolites BYI 08330-enol cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-
methoxy-1-azaspiro[4.5]dec-3-en-2-one, BYI 08330-ketohydroxy cis-3-
(2,5-dimethylphenyl)-3-hydroxy-8-methoxy-1-azaspiro[4.5]decane-2,4-
dione, BYI 08330-enol-Glc cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-
azaspiro[4.5]dec-3-en-4-yl beta-D-glucopyranoside, and BYI 08330-mono-
hydroxy cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-
azaspiro[4.5]decan-2-one, calculated as spirotetramat equivalents, in
or on taro, leaves at 9 ppm; watercress at 1.5 ppm; pomegranate at 0.5
ppm; banana at 4 ppm; vegetable, bulb, group 3-07 at 0.6 ppm; berry,
low growing, except strawberry, subgroup 13-07H at 0.3 ppm; bushberry,
subgroup 13-07B at 3 ppm; artichoke, globe at 2 ppm; vegetable,
fruiting, group 8-10 at 2.5 ppm; fruit, pome, group 11-10 at 0.7 ppm;
fruit, citrus, group 10-10 at 0.6 ppm; pineapple at 0.3 ppm; pineapple,
process residue at 0.36 ppm; coffee, green beans at 0.2 ppm; and
coffee, roast beans at 0.32 ppm. Spirotetramat residues are quantified
in raw agricultural commodities by HPLC/triple stage quadrupole mass
spectrometry (HPLC/MS/MS) using the stable isotopically labeled
analytes as internal standards. Contact: Laura Nollen, (703) 305-7390,
email address: nollen.laura@epa.gov.
8. PP 1F7845. (EPA-HQ-OPP-2011-0458). Bayer CropScience, 2 T. W.
Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709,
requests to establish a tolerance in 40 CFR part 180 for residues of
the fungicide trifloxystrobin, benzeneacetic acid, (E,E)-[alpha]-
(methoxyimino)-2-[[[[1-[3-(trifluoromethyl) phenyl] ethylidene]
amino]oxy]methyl]-methyl ester, and the free form of its acid
metabolite CGA-321113, (E,E)-methoxyimino-[2-[1-(3-trifluoromethyl-
phenyl)-ethylideneaminooxymethyl]-phenyl]acetic acid, in or on
artichoke, globe at 1.0 ppm. A practical analytical method for
detecting and measuring levels of trifloxystrobin, in or on raw
agricultural commodities is based on crop specific cleanup procedures
and determination by GC/NPD. A newer analytical method is available by
LC/MS/MS with electrospray interface, operated in the positive ion
mode. Contact: Tawanda Maignan, (703) 308-8050, email address:
maignan.tawanda@epa.gov.
9. PP 1F7954. (EPA-HQ-OPP-2012-0029). E. I. DuPont de Nemours and
Company, DuPont Crop Protection, 1007
[[Page 20337]]
Market Street, Wilmington, DE 19898, requests to establish a tolerance
in 40 CFR part 180 for residues of the chlorantraniliprole, 3-bromo-N-
[4-chloro-2-methyl-6-[(methylamino)-carbonyl]phenyl]-1-(3-chloro-2-
pyridinyl)-1H-pyrazole-5-carboxamide, in or on oilseed, rapeseed,
subgroup 20A at 2.0 ppm; oilseed, sunflower, subgroup 20B at 2.0 ppm;
oilseed, cottonseed, subgroup 20C at 0.3 ppm; soybean, aspirated grain
fractions at 300 ppm; vegetable, legume, group 6 at 2.0 ppm; vegetable,
foliage of legume, group 7 at 30 ppm; and forage, vegetable, foliage of
legume, group 7 at 90 ppm. An analytical residue method has been
submitted to EPA which permits determination of trace residues of the
parent compound on various food and feed commodities. Contact: Jennifer
Urbanski, (703) 347-0156, email address: urbanski.jennifer@epa.gov.
Amended Tolerances
1. PP 1E7951. (EPA-HQ-OPP-2011-1011). Interregional Research
Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton,
NJ 08540, requests to amend the tolerances in 40 CFR 180.117 for
residues of the herbicide S -ethyl dipropylthiocarbamate (EPTC),
including its metabolites and degradates, determined by measuring only
the sum of S -ethyl dipropylthiocarbamate, S -ethyl (2-hydroxypropyl)
propylcarbamothioate, S -(2-hydroxyethyl)dipropylcarbamothioate, and S
-ethyl (3-hydroxypropyl)propylcarbamothioate, calculated as the
stoichiometric equivalent of S -ethyl dipropylthiocarbamate, by
removing the following established tolerances: Fruit, citrus, group 10
at 0.1 ppm; safflower, seed at 0.08 ppm; and sunflower, seed at 0.08
ppm, as these commodities are included in updated crop groups or
subgroups listed under ``New Tolerances'' for PP 1E7951. Contact:
Sidney Jackson, (703) 305-7610, email address: jackson.sidney@epa.gov.
2. PP 1E7958. (EPA-HQ-OPP-2012-0107). Interregional Research
Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton,
NJ 08540, requests to amend 40 CFR 180.641 for residues of the
insecticide spirotetramat, cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-
1-azaspiro[4.5]dec-3-en-4-yl-ethyl carbonate and its metabolites BYI
08330-enol cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-
azaspiro[4.5]dec-3-en-2-one, BYI 08330-ketohydroxy cis-3-(2,5-
dimethylphenyl)-3-hydroxy-8-methoxy-1-azaspiro[4.5]decane-2,4-dione,
BYI 08330-enol-Glc cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-
azaspiro[4.5]dec-3-en-4-yl beta-D-glucopyranoside, and BYI 08330-mono-
hydroxy cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-
azaspiro[4.5]decan-2-one, calculated as spirotetramat equivalents, by
removing the established tolerances: Onion, bulb, subgroup 3A-07 at
0.30 ppm; fruit, citrus, group 10 at 0.60 ppm; fruit, pome, group 11 at
0.70 ppm; okra at 2.5 ppm; and vegetable, fruiting, group 8 at 2.5 ppm,
as they will be superseded by inclusion in updated crop groups or
subgroups listed under ``New Tolerances''. Contact: Laura Nollen, (703)
305-7390, email address: nollen.laura@epa.gov.
New Tolerance Exemptions
1. PP 1E7912. (EPA-HQ-OPP-2012-0014). ICR, Inc., 1330 Dillon
Heights Ave, Catonsville, MD on behalf of Triton Systems, Inc., 200
Turnpike Road, Chelmsford, MA 01824, requests to establish an exemption
from the requirement of a tolerance for residues of 1,2-Ethanediamine,
N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, with
number average molecular weight greater than 10,000 daltons, (CAS No.
35297-61-1) under 40 CFR 180.960 when used as a pesticide inert
ingredient microencapsulation in pesticide formulations. The petitioner
believes no analytical method is needed because this information is
generally not required when all criteria for polymer exemption under 40
CFR 723.250 are met. Contact: Anthony Britten, (703) 308-8179, email
address: britten.anthony@epa.gov.
2. PP 1E7938. (EPA-HQ-OPP-2012-0043). Honeywell International,
Inc., 101 Columbia Road, Morristown, NJ 07962-1053, requests to
establish an exemption from the requirement of a tolerance for residues
of trans-1,3,3,3-tetrafluoroprop-1-ene, (CAS No. 29118-24-9) under 40
CFR 180.910, 180.930, and 180.940 when used as a pesticide inert
ingredient propellant in pesticide formulations. The petitioner
believes no analytical method is needed because this is a petition for
exemption from the requirement of a tolerance. Contact: Lisa Austin,
(703) 305-7894, email address: austin.lisa@epa.gov.
3. PP 1F7960. (EPA-HQ-OPP-2012-0152). Enerfab, Inc., 4955 Spring
Grove Avenue, Cincinnati, OH 45232, requests to establish an exemption
from the requirement of a tolerance for residues of the antimicrobial
gaseous chlorine dioxide, on tomato. EPA Method 300, Ion
Chromatography, was used for measuring chlorite and chlorate residues
rinsed from surface of produce treated with chlorine dioxide gas.
Contact: Jaclyn Carl, (703) 347-0213, email address:
carl.jaclyn@epa.gov.
Amended Tolerance Exemption
PP 1F7857. (EPA-HQ-OPP-2012-0109). Syngenta Seeds, Inc., Field
Crops NAFTA, P.O. Box 12257, 3054 E. Cornwallis Road, Research Triangle
Park, NC 27709-2257, requests to amend an exemption from the
requirement of a tolerance in 40 CFR 174.532 for residues of the plant-
incorporated protectant (PIP), Bacillus thuringiensis eCry3.1Ab protein
in corn, in or on the food and feed commodities of corn; corn, field;
corn, sweet; and corn, pop. The petitioner believes no analytical
method is needed because an exemption from the requirement of a
tolerance is being sought. However, in response to an Agency request,
the Petitioner has submitted an immunoassay method for determination of
eCry3.1Ab protein in corn tissues. Contact: Mike Mendelsohn, (703) 308-
8715, email address: mendelsohn.mike@epa.gov.
List of Subjects in 40 CFR Parts 174 and 180
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: March 16, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2012-8095 Filed 4-3-12; 8:45 am]
BILLING CODE 6560-50-P