[Federal Register: February 6, 2008 (Volume 73, Number 25)]
[Notices]
[Page 6964-6967]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06fe08-54]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2008-0046; FRL-8350-9]
Notice of Filing of Pesticide Petitions for Residues of Pesticide
Chemicals in or on Various Commodities
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of pesticide
petitions proposing the establishment or modification of regulations
for residues of pesticide chemicals in or on various commodities.
DATES: Comments must be received on or before March 7, 2008.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest, by one
of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket'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 identification
(ID) number and the pesticide petition number of interest. EPA's policy
is that all comments received will be included in the docket without
change and may be made available on-line 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 e-mail. The regulations.gov
website 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 e-mail comment directly to EPA
without going through regulations.gov, your e-mail 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 in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
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. Publicly available docket materials are available
electronically 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: The person listed at the end of the
pesticide petition summary of interest.
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 e-mail. 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.
[[Page 6965]]
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.
II. Docket ID Numbers
When submitting comments, please use the docket ID number and the
pesticide petition number of interest, as shown in the table.
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PP Number Docket ID Number
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PP 7E7258 EPA-HQ-OPP-2008-0049
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PP 7E7286 EPA-HQ-OPP-2008-0049
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PP 7E7268 EPA-HQ-OPP-2007-1199
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PP 7E7287 EPA-HQ-OPP-2007-1159
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PP 7E7298 EPA-HQ-OPP-2006-0875
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PP 7E7300 EPA-HQ-OPP-2007-1202
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PP 7F7289 EPA-HQ-OPP-2008-0066
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PP 7F7304 EPA-HQ-OPP-2008-0065
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PP 7E7239 EPA-HQ-OPP-2008-0039
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PP 7E7241 EPA-HQ-OPP-2008-0040
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PP 7E7309 EPA-HQ-OPP-2008-0044
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PP 7E7261 EPA-HQ-OPP-2008-0043
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PP 7E7303 EPA-HQ-OPP-2008-0060
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PP 7F7179 EPA-HQ-OPP-2008-0041
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III. What Action is the Agency Taking?
EPA is printing notice of the filing of pesticide petitions
received under section 408 of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, proposing the establishment or modification of
regulations in 40 CFR part 180 for residues of pesticide chemicals in
or on various food commodities. EPA has determined that the pesticide
petitions described in this notice contain data or information
regarding the elements set forth 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. Additional data may be needed before EPA rules on these
pesticide petitions.
Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
included in this notice, prepared by the petitioner, is included in a
docket EPA has created for each rulemaking. The docket for each of the
petitions is available on-line at http://www.regulations.gov.
A. New Tolerances
1. PP 7E7258 and 7E7286. (EPA-HQ-OPP-2008-0049). Interregional
Research Project Number 4 (IR-4), 681 U.S. Highway 1 South,
North Brunswick, NJ 08902-3390, proposes to establish a tolerance for
residues of triflumizole, [1-[1-((4-chloro-2-(trifluoromethyl)
phenyl)imino)-2propoxyethyl]-1H-imidazole] in or on food commodities
for PP 7E7258: Leafy greens except spinach (subgroup 4A) and cilantro,
leaves at 35 parts per million (ppm); swiss chard at 18 ppm; pineapple
at 4.0 ppm; papaya; sapote black; canistel; sapote, mamey; mango;
sapodilla and star apple at 2.5 ppm; hop, dried cones at 50.0 ppm; and
for PP 7E7286: Brassica, head and stem, subgroup 5A at 5.0 ppm. The
analytical method is suitable for analyzing crops for residues of
triflumizole and its aniline containing metabolites at the proposed
tolerance levels. The analytical method has been independently
validated. Residue levels of triflumizole are converted to FA-1-1 by
acidic and alkaline reflux, followed by distillation. Residues are then
extracted and subjected to SPE purification. Detection and quantitation
are conducted by gas chromatograph equipped with nitrogen phosphorus
detector, electron capture detector or mass spectrometry detection. The
limit of quantitation of the method has been determined in the range of
0.01 ppm to 0.05 ppm for the combined residues of triflumizole and FA-
1-1. The enforcement methodology has been submitted to the Food and
Drug Administration for publication in the Pesticide Analytical Manual
(PAM II) Vol. II. Contact: Sidney Jackson, telephone number: (703) 305-
7610; e-mail address: jackson.sidney@epa.gov.
2. PP 7E7268. (EPA-HQ-OPP-2007-1199). Valent USA Corporation, 1600
Riviera Avenue, Walnut Creek, CA 94596-8025, proposes to establish a
tolerance for residues of the uniconazole, [(E)-(+)-(S)-1-(4-
chlorophenyl)-4,4-dimethyl-2-(1,2,4-triazol-1-yl)-pent-1-ene-3-ol] in
or on food commodity vegetables, fruiting, group 8 at 0.01 ppm. An
adequate analytical enforcement method is available for the
determination of residues of uniconazole in plants. The analytical
method has been validated by an independent laboratory. Contact: Shaja
R. Brothers, telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.
3. PP 7E7287. (EPA-HQ-OPP-2007-1159). Interregional Research
Project 4 (IR-4), Rutgers, The State University of New Jersey,
500 College Road East, Suite 201 W, Princeton, NJ 08540, proposes to
establish a tolerance for residues of gamma-cyhalothrin ((S)-[alpha]-
cyano-3-phenoxybenzyl (Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoripropenyl)-
2,2-dimethylcyclopropanecarboxylate) in or on food commodities
pistachio at 0.05 ppm and okra at 0.2 ppm. An adequate analytical
method is available for enforcement purposes. In the Federal Register
of April 8, 2004 (69 FR 18480) (FRL-7353-4), the ICI method 81 for
lamda-cyhalothrin has been validated by EPA. Given the enantiomeric
relation of gamma-cyhalothrin to lambda-cyhalothrin and the fact that
the method does not provide chiral resolution, the method is also
applicable to gamma-cyhalothrin. Contact: Susan Stanton, telephone
number: (703) 305-5218; e-mail address: stanton.susan@epa.gov.
4. PP 7E7298. (EPA-HQ-OPP-2006-0875). Interregional Research
Project Number 4 (IR-4), 681 U.S. Highway 1 South, North
Brunswick, NJ 08902-3390, proposes to establish a tolerance for
residues of the insecticide fenpropathrin, alpha-cyano-3-phenoxybenzyl
2,2,3,3-tetramethylcyclopropanecarboxylate in or on food commodities
caneberry subgroup 13-07A at 12 ppm and olives at 5 ppm. Adequate
analytical methodology is available to detect and quantify
fenpropathrin at residue levels in numerous matrices. The methods use
solvent extraction and partition and/or column chromatography clean-up
steps, followed by separation and quantitation using capillary gas
liquid chromatography (GLC) with FID. The extraction efficiency has
been validated using radiocarbon samples from the plant and animal
metabolism studies. The enforcement methods have been validated at
independent laboratories and by EPA. The limit of quantification (LOQ)
for fenpropathrin in raw agricultural commodity samples is usually 0.01
ppm. Contact: Sidney Jackson, telephone number: (703) 305-7610; e-mail
address: jackson.sidney@epa.gov.
5.PP 7E7300. (EPA-HQ-OPP-2007-1202). Interregional Research Project
Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ
05840, proposes to establish a tolerance for
[[Page 6966]]
residues of propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-
dioxolan-2-yl] methyl]-1H-1,2,4-triazole and its metabolites determined
as 2,4,-dichlorobenzoic acid and expressed as parent compound in or on
food commodities beet, garden, roots at 0.6 ppm; parsley, leaves at 13
ppm; parsley, dried leaves at 60 ppm; coriander, fresh at 13 ppm;
vegetable, leaves of root and tuber, group 2 at 8.0 ppm; pineapple
(post harvest) at 0.9 ppm; and turnip, roots at 0.2 ppm. Analytical
methods AG-626 and AG-454A were developed for the determination of
residues of propiconazole and its metabolites containing the DCBA
moiety. Analytical method AG-626 has been accepted and published by EPA
as the tolerance enforcement method for crops. The limit of
quantitation (LOQ) for the method is 0.05 ppm. Contact: Shaja R.
Brothers, telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.
6. PP 7F7289. (EPA-HQ-OPP-2008-0066). Syngenta Crop Protection,
Inc., P.O. Box 18300, Greensboro, NC 27419, proposes to establish a
tolerance for residues of the herbicide fluazifop-p-butyl in or on food
commodities dry beans at 25 ppm; dry beans at 25 ppm; peanuts at 1.5
ppm; soybean at 2.5 ppm; soybean meal at 2.5 ppm; and soybean refined
oil at 0.01 ppm. The analytical method utilized in the studies
supporting this action is based upon the Pesticide Analytical Method
(PAM) Vol. II, Method II for the enforcement of tolerances for
fluazifop-p-butyl residues of concern for oily and non-oily crops.
Using this method, residues of fluazifop-p-butyl or fluazifop, and any
ester or acid conjugates are extracted from crop samples using a
mixture of acetonitrile and dilute acid. Residues are then hydrolyzed
using hydrochloric acid to fluazifop and further cleaned up via solvent
partitioning, and absorption chromatography. Once sufficiently cleaned
up, the samples are subsequently derivatized to form the methyl ester
derivative of fluazifop prior mass-selective detection using gas
chromatography/mass spectrometry (GC/MS). It should be noted that this
analytical method does not distinguish the optical isomers of
fluazifop-butyl or fluazifop but instead, hydrolyzes these residues to
a common moiety (fluazifop acid) and as such, the detected residues are
reported as ``fluazifop'' residues. Contact: James M. Stone, telephone
number: (703) 305-7391; e-mail address: stone.james@epa.gov.
7. PP 7F7304. (EPA-HQ-OPP-2008-0065). Bayer CropScience, 2 T.W.
Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709,
proposes to establish a tolerance for residues of the herbicide
propoxycarbazone, methyl 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-
1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl] benzoate and its
metabolite, methyl 2-[[[(4,5-dihydro-3-(2-hydroxypropoxy)-4-methyl-5-
oxo-1H-1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl]benzoate (MKH-6561)
in or on food commodities grass forage at 20 ppm, and grass hay at 25
ppm. The proposed tolerance expression is MKH-6561 and Pr-2-OH MKH-
6561. An analytical method was developed to measure these two analytes
in plant matrices. The method was validated in grass tissues and the
analysis by high performance liquid chromatography-electrospray
ionization/tandem mass spectrometry (LC/MS/MS). In animal matrices, the
proposed tolerance expression is MKH-6561. The proposed tolerance
expression is MKH-6561. An analytical method was developed to measure
this analyte in animal tissues and milk. The method was validated in
animal tissues and milk. MKH-6561 was extracted from the tissues with
0.05 M NH4OH using accelerated solvent extraction. Trifluoroacetic acid
(0.5 mL) and an isotopically labeled internal standard were added to
the extract which was then centrifuged at 2,000 rpm for 10 minutes.
Approximately half of the sample was loaded onto a C-18 SPE cartridge.
The C-18 SPE cartridge was washed with aqueous trifluoroacetic acid
(0.1%) and aqueous acetic acid (0.1%). A three to one mixture of
acetonitrile and aqueous acetic acid (0.1%) was used to elute the
analytes from the C-18 SPE cartridge. Water and acetic acid were added
to the sample which was analyzed by LC/MS/MS. Milk samples were
analyzed by amending an aliquot of milk with trifluororacetic acid (0.5
mL) and isotopically labeled internal standard. The sample was purified
by C-18 SPE as described above. The resultant sample was analyzed by
LC/MS/MS. Contact: James M. Stone, telephone number: (703) 305-7391; e-
mail address: stone.james@epa.gov.
B. Amendment to Existing Tolerance
PP 7F7304. (EPA-HQ-OPP-2008-0065). Bayer CropScience, 2 T.W.
Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709,
proposes to amend the tolerances in 40 CFR 180.600 by increasing the
established tolerances for residues of the herbicide propoxycarbazone,
methyl 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazol-1-
yl)carbonyl]amino]sulfonyl]benzoate (Pr-2-OH MKH-6561) in or on the
food commodities cattle, goat, horse, sheep meat from 0.05 ppm to 0.1
ppm; meat byproducts from 0.3 ppm to 1.0 ppm; and milk from 0.03 ppm to
0.05 ppm. The analytical method is described (see Unit III. A. 7).
Contact: James M. Stone, telephone number: (703) 305-7391; e-mail
address: stone.james@epa.gov.
C. New Exemption from Tolerances
1. PP 7E7239. (EPA-HQ-OPP-2008-0039). Whitmire Micro-Gen c/o Landis
International, Inc., P.O. Box 5126, Valdosta, GA 31603-5136, proposes
to amend 40 CFR 180 by establishing an exemption from the requirement
of a tolerance under 40 CFR 180.930 for residues of acetone, when used
as an inert ingredient in a pesticide product when used in accordance
with good agricultural practice as a solvent or co-solvent in pesticide
formulations applied to animals. Because this petition is a request for
an exemption from the requirement of a tolerance, no analytical method
is required. Contact: Karen Samek, telephone number: (703) 347-8825; e-
mail address: samek.karen@epa.gov.
2. PP 7E7241. (EPA-HQ-OPP-2008-0040). Whitmire Micro-Gen c/o Landis
International, Inc., P.O. Box 5126, Valdosta, GA 31603-5136, proposes
to amend 40 CFR 180 by establishing an exemption from the requirement
of a tolerance under 40 CFR 180.910 for residues of potassium benzoate,
when used as an inert ingredient in a pesticide product when used in
accordance with good agricultural practice as a preservative in
pesticide products applied to growing crops or to raw agricultural
commodities after harvest. Because this petition is a request for an
exemption from the requirement of a tolerance, no analytical method is
required. Contact: Karen Samek, telephone number: (703) 347-8825; e-
mail address: samek.karen@epa.gov.
3. PP 7E7309. (EPA-HQ-OPP-2008-0044). Syngenta Crop Protection,
P.O. Box 18300, Greensboro, NC 27409, proposes to amend 40 CFR 180 by
establishing an exemption from the requirement of a tolerance under 40
CFR 180.910 for residues of 1,2-benzisothiazolin-3-one (BIT) as an
inert ingredient in post-harvest applications at a maximum of 0.1% in
an end-use product formulation. In September 2005, EPA published a
Reregistration Eligibility Decision (RED) for BIT. This extensive
document provides an overview of the available information for BIT.
Because this petition is a request for an exemption from the
requirement of a tolerance, no analytical method is required. Contact:
Karen Samek, telephone number: (703) 347-
[[Page 6967]]
8825; e-mail address: samek.karen@epa.gov.
4. PP 7E7261. (EPA-HQ-OPP-2008-0043). Monsanto Company, 1300 ``I''
St., NW. Suite 450 East, Washington, DC 20005, proposes to amend 40 CFR
180 by establishing an exemption from the requirement of a tolerance
for residues of sodium sulfite in or on any food or feed commodity when
used as an inert ingredient in a pesticide product with the following
limitations: Not to exceed 0.8% by weight in the formulated product.
For use only in formulated products containing the active ingredient
glyphosate and applied only to growing crops. Because this petition is
a request for an exemption from the requirement of a tolerance, no
analytical method is required. Contact: Karen Samek, telephone number:
(703) 347-8825; e-mail address: samek.karen@epa.gov.
5. PP 7E7303. (EPA-HQ-OPP-2008-0060). LANXESS Corporation, 111 RIDC
Park West Dr., Pittsburgh, PA 15275, proposes to amend 40 CFR 180 by
establishing an exemption from the requirement of a tolerance under 40
CFR 180.910 for residues of methanol, (phenylmethoxy)- (CAS Reg. No.
14548-60-8) applied to growing crops and raw agricultural commodities
after harvest at no more than 0.25% of the total pesticide formulation
when used as either an in-can preservative or as a colorant in seed
coatings. Because this petition is a request for an exemption from the
requirement of a tolerance, no analytical method is required. Contact:
Karen Samek, telephone number: (703) 347-8825; e-mail address:
samek.karen@epa.gov.
D. Amendment to Existing Exemption from a Tolerance
PP 7F7179. (EPA-HQ-OPP-2008-0041). ETI H2O, 1725 Gillespie Way, El
Cajon, CA 92020, proposes to amend the existing exemption from the
requirement of a tolerance in 40 CFR 180.940(a) for residues of sodium
lauryl sulfate, (CAS Reg. No. 151-21-3) as a component of food contact
sanitizing solutions applied to all food contact surfaces in public
eating places, dairy-processing equipment, and food-processing
equipment and utensils at a maximum level in the end-use concentration
of 350 ppm. Because this petition is a request for an exemption from
the requirement of a tolerance, no analytical method is required.
Contact: Karen Samek, telephone number: (703) 347-8825; e-mail address:
samek.karen@epa.gov.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: January 30, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E8-2172 Filed 2-5-08; 8:45 am]
BILLING CODE 6560-50-S