[Federal Register Volume 66, Number 241 (Friday, December 14, 2001)]
[Notices]
[Pages 64828-64832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30915]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1057; FRL-6812-4]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket control number PF-1057, must be 
received on or before January 14, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-1057 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Dani Daniel, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-5409; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-1057. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.

[[Page 64829]]

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-1057 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-1057. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any 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 version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified under FOR FURTHER INFORMATION 
CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in 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 petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

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

    Dated: November 29, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

 Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the Federal Food, Drug, and 
Cosmetic Act (FFDCA). The summary of the petition was prepared by the 
petitioner and represents the view of the petitioners. EPA is 
publishing the petition summary verbatim without editing it in any way. 
The petition summary announces the availability of a description of the 
analytical methods available to EPA for the detection and measurement 
of the pesticide chemical residues or an explanation of why no such 
method is needed.

Sygenta Crop Protection Inc.

PP 1E6349

     EPA has received a pesticide petition (1E6349) from Sygenta Crop 
Protection Inc., P.O. Box 18300, Greensboro, NC 27419-8300 proposing, 
pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 
CFR part 180 by establishing a tolerance for residues of thiamethoxam 
and its metabolite, (N-(2-chloro-thiazol-5-ylmethyl)-N'methyl-N-nitro-
guanidine, in or on the raw agricultural commodity imported green and 
roasted coffee beans and instant coffee at 0.05 parts per million 
(ppm). EPA has determined that the petition contains data or 
information regarding the elements set forth in section 408(d)(2) of 
the FFDCA; however, EPA has not fully evaluated the sufficiency of the 
submitted data at this time or whether the data support granting of the 
petition. Additional data may be needed before EPA rules on the 
petition.

A. Residue Chemistry

    1. Plant metabolism. The primary metabolic pathways of thiamethoxam 
in plants (corn, rice, pears, and cucumbers) were similar to those 
described for animals, with certain extensions of the pathway in 
plants. Parent compound, thiamethoxam, and its metabolite, (N-(2-
chloro-thiazol-5-ylmethyl)-N'methyl-N-nitro-guanidine, were the major 
residues in all crops. The metabolism of thiamethoxam in plants and 
animals is understood for the purposes of the proposed tolerances. 
Parent thiamethoxam and the metabolite, are the residues of concern for 
tolerance setting purposes.
    2. Analytical method. Syngenta Crop Protection Inc. has submitted 
practical analytical methodology for detecting and measuring levels of 
thiamethoxam in or on raw agricultural commodities. The method is based 
on crop specific cleanup procedures and determination by liquid 
chromatography with either ultraviolet (UV) or mass spectrometry (MS) 
detection. The limit of detection (LOD) for each analyte of this method 
is 1.25 nanogram (ng) injected for samples analyzed by UV and 0.25 ng 
injected for samples analyzed by MS, and the limit of quantitation 
(LOQ) is 0.005 ppm for

[[Page 64830]]

milk and juices and 0.01 ppm for all other substrates.
    3. Magnitude of residues. A residue program was performed for 
thiamethoxam on coffee as prescribed in draft EPA Guidance on Import 
Tolerances. A total of nine trials were conducted in the major coffee 
producing countries of Brazil (four), Columbia (three) and Mexico 
(two). The applications in these trials consisted of soil applications 
(trench, furrow or broadcast) at the proposed maximum rate of 300 grams 
active ingredient per hectare. The first applications were made just 
after petal fall and a second application at the beginning of fruit 
development. There were no detectable residues <0.02 ppm of 
thiamethoxam or the metabolite CGA-322701 in coffee berries or dried 
green coffee beans.
     In addition, there was a single 5X exaggerated rate processing 
trial conducted. There were detectable residues of thiamethoxam and its 
metabolite (<0.022 ppm and 0.012 ppm, respectively) in the dry beans 
for processing. There were no detectable residues (<0.005 ppm) of 
thiamethoxam or it metabolite, in roasted beans, ground roasted beans, 
brewed extracts, spent grounds or instant coffee.

B. Toxicological Profile

    1. Acute toxicity. The acute oral LD50 for thiamethoxam 
in the rat is 1,563 mg/kg body weight. The acute dermal LD50 
of thiamethoxam is >2,000 milligrams/kilogram (mg/kg) body weight. 
Thiamethoxam is non-toxic at atmospheric concentrations of 3.72 mg/L. 
Thiamethoxam is minimally irritating to the eye, non-irritating to 
skin, and is not a dermal sensitizer.
    In an acute neurotoxicity screening study in rats (OPPTS 
870.6200a), the no observed adverse effect level (NOAEL) was 100 mg/kg/
day with a NOAEL of 500 mg/kg/day based on drooped palpebral closure, 
decrease in rectal temperature and locomotor activity and increase in 
forelimb grip strength (males only). At higher dose levels, mortality, 
abnormal body tone, ptosis, impaired respiration, tremors, longer 
latency to first step in the open field, crouched over posture, gait 
impairment, hypo-arousal, decreased number of rears, uncoordinated 
landing during the righting reflex test, slight lacrimation (females 
only), and higher mean average input stimulus value in the auditory 
startle response test (males only).
    2. Genotoxicity. In gene mutation studies with S. typhimurium and 
E. coli (OPPTS 870.5100 and 870.5265), there was no evidence of gene 
mutation when tested up to 5,000 g/plate and there was no 
evidence of cytotoxicity. In a gene mutation study with chinese hamster 
V79 cells at HGPRT focus (OPPTS 870.5300) there was no evidence of gene 
mutation when tested up to the solubility limit.
     In a CHO cell cytogenetics study (OPPTS 870.5375) there was no 
evidence of chromosomal aberrations when tested up to cytotoxic or 
solubility limit concentrations.
     An in vivo mouse bone marrow micronucleus study (OPPTS 870.5395) 
was negative when tested up to levels of toxicity in whole animals; 
however, there was no evidence of target cell cytotoxicity.
     An UDS assay (OPPTS 870.5550) was negative when tested up to 
precipitating concentrations.
    3. Reproductive and developmental toxicity. A prenatal 
developmental study in the rat (OPPTS 870.3700) resulted in maternal 
and developmental NOAELs of 30 mg/kg/day and 200 mg/kg/day, 
respectively. The maternal lowest observed adverse effect level (LOAEL) 
is 200 mg/kg/day based on decreased body weight, body weight gain and 
food consumption. The developmental LOAEL was 750 mg/kg/day based on 
decreased fetal body weight and an increased incidence of skeletal 
anomalies.
    A prenatal developmental study in the rabbit (OPPTS 870.3700) 
resulted in maternal and developmental NOAELs of 50 mg/kg/day. The 
maternal and developmental LOAEL is 150 mg/kg/day. The maternal LOAEL 
is based on maternal deaths, hemorrhagic discharge, decreased body 
weight, and food intake during the dosing period. The developmental 
LOAEL is based on decreased fetal body weights, increased incidence of 
post-implantation loss and a slight increase in the incidence of a few 
skeletal anomolies/variations.
    In a reproduction and fertility effects study in rats (OPPTS 
870.3800) the parental/systemic NOAEL is 1.84 (males), 202.06 (females) 
mg/kg/day; the reproductive NOAEL is 0.61 (males), 202.06 (females) mg/
kg/day, and the offspring NOAEL is 61.25 (males), 79.20 (females) mg/
kg/day. The parental/systemic LOAEL is 61.25 (males), not determined 
(females) mg/kg/day based on increased incidence of hyaline change in 
renal tubules in F0 and F1 males. The reproductive LOAEL is 1.84 
(males), not determined females mg/kg/day based on increased incidence 
and severity of tubular atrophy observed in testes of the F1 generation 
males. The offspring LOAEL is 158.32 (males), 202.06 (females) mg/kg/
day based on reduced body weight gain during the lactation period in 
all litters.
    4. Subchronic toxicity. A 90-day oral toxicity study in rats (OPPTS 
870.3100) resulted in a NOAEL of 1.74 (males) and 92.5 (females) mg/kg/
day. The LOAEL is 17.64 (male), 182.1 (female) mg/kg/day based on 
increased incidence of hyaline change of renal tubules epithelium 
(males), fatty change in adrenal gland of females, liver changes in 
females, all at the LOAEL.
    A 90-day oral toxicity study in mice (OPPTS 870.3100) resulted in 
an NOAEL of 1.41 (males) and 19.2 (females) mg/kg/day. The LOAEL was 
14.3 (male) and 231 (female) mg/kg/day based on an increased incidence 
of hepatocellular hypertrophy. At higher dose levels: decrease in body 
weight and body weight gain, necrosis of individual hepatocytes, 
pigmentation of Kupffer cells, and a lymphocytic infiltration of the 
liver in both sexes; slight hematologic effects and decreased absolute 
and relative kidney weights in males; and ovarian atrophy, decreased 
ovary and spleen weights and increased liver weights in females.
    In a 90-day oral toxicity study in dogs (OPPTS 870.3150), the NOAEL 
is 8.23 (males) and 9.27 (females) mg/kg/day. The LOAEL is 32.0 (male), 
33.9 (female) mg/kg/day based on slightly prolonged prothrombin times 
and decreased plasma albumin and A/G ration (both sexes); decreased 
calcium levels and ovary weights and delayed maturation in the ovaries 
(female); decreased cholesterol and phospholipid levels, testes 
weights, spermatogenesis, and spermatic giant cells in testes (male).
     In a 28-day dermal study in rats (OPPTS 870.3200) the NOAEL was 
250 (male) and 60 (female) mg/kg/day. The LOAEL was 1,000 (male),and 
250 (female) mg/kg/day based on an increased plasma glucose, 
triglyceride levels, and alkaline phosphatase activity and an 
inflammatory cell infiltration in the liver and necrosis if single 
hepatocytes in females and a hyaline change in renal tubules and a very 
slight reduction in body weight in males. At higher dose levels in 
females, chronic tubular lesions in the kidneys and an inflammatory 
cell infiltration in the adrenal cortex were observed.
     In a subchronic neurotoxicity screening study in rats (OPPTS 
870.6200) the NOAEL was 95.4 (male) and 216.4 (female) mg/kg/day, both 
at the highest dose tested. The LOAEL was not determined. No treatment-
related observations at any dose level. LOAEL was not achieved. May not 
have been tested at sufficiently high dose levels; however, a new study 
is not required because the weight of the evidence from other toxicity 
studies indicates no evidence of concern.

[[Page 64831]]

    5.  Chronic toxicity. In a chronic toxicity study in dogs (OPPTS 
870.4100) the NOAEL was 4.05 (male), and 4.49 (female) mg/kg/day. The 
LOAEL was 21.0 (male) and 24.6 (female) mg/kg/day based on an increase 
of creatinine in both sexes, transient decrease in food consumption in 
females, and an occasional increase in urea levels, decrease in ALT, 
and atrophy of seminiferous tubules in males.
     In a mouse carcinogenicity study (OPPTS 870.4200) the NOAEL was 
2.63 (male) and 3.68 (female) mg/kg/day. The LOAEL was 63.8 (male) and 
87.6 (female) mg/kg/day based on hepatocyte hypertrophy, single cell 
necrosis, inflammatory cell infiltration, pigment deposition, foci of 
cellular alteration, hyperplasia of Kupffer cells and increased mitotic 
activity, also an increase in the incidence of hepatocellular adenoma 
(both sexes). At higher doses, there was an increase in the incidence 
of hepatocelluar adenocarcinoma (both sexes) and the number of animals 
with multiple tumors, evidence of carcinogenicity. In a combined 
chronic caricinogenicity study in rats (OPPTS 870.4300), the NOAEL was 
21.0 (male) and 50.3 (female) mg/kg/day. The LOAEL was 63.0 (male) and 
255 (female) mg/kg/day based on an increased incidence of lymphocytic 
infiltration of the renal pelvis and chronic nephropathy in males and 
decreased body weight gain, slight increase in the severity of 
hemosiderosis of the spleen, foci of cellular alteration in liver and 
chronic tubular lesions in kidney in females. No evidence of 
carcinogenicity.
     In a hepatic cell proliferation study in mice, the NOAEL was 16 
(male) and 20 (female) mg/kg/day. The LOAEL was 72 (male) and 87 
(female) mg/kg/day based on proliferative activity of hepatocytes. At 
higher dose levels, increases in absolute and relative liver weights, 
speckled liver, heptocellular glycogenesis/fatty change, heptocellular 
necrosis, apoptosis and pigmentation were observed.
     In a 28-day feeding study to assess replicative DNA syntehsis in 
the male rat, the NOAEL was 711 mg/kg/day. The LOAEL was not 
established. Immunohistochemical staining of liver sections from 
control, and high dose animals for proliferating cell nuclear antigen 
gave no indication for a treatment-related increase in the fraction of 
DNA syntesizing hepatocytes in S-phase. Thiamethoxam did not stimulate 
hepatocyte cell proliferation in male rats.
     In a special study to assess liver biochemistry in the mouse, the 
NOAEL was 17 (male) and 92 (female) mg/kg/day. The LOAEL was 74 (male) 
and 92 (female) mg/kg/day based on marginal to slight increases in 
absolute and relative liver weights, a slight increase in the 
microsomal protein content of the livers, moderate increases in the 
cytochrome P450 content, slight to moderate increases in the activity 
of several microsomal enzymes, slight to moderate induction of 
cytosolic glutathionw S-transfersase activity. Treatment did not affect 
peroxisomal fatty acid B-oxidation.
    6. Animal metabolism. The metabolism of thiamethoxam in rats and 
livestock animals is adequately understood. The residues of concern 
have been determined to be parent thiamethoxam and its metabolite (N-
(2-chloro-thiazol-5-ylmethyl)-N'methyl-N-nitro-guanidine).
    7. Metabolite toxicology. For risk assessment purposes, residues of 
the metabolite corrected for molecular weight are considered to be 
toxicologically equivalent to parent thiamethoxam.

C. Aggregate Exposure

     1. Dietary exposure. Permanent tolerances have been established 
(40 CFR 180.565) for the combined residues of the insecticide 
thiamethoxam, 3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-
nitro-4H-1,3,5-oxadiazin-4-imine and it metabolite (N-(2-chloro-
thiazol-5-ylmethyl)-N'-methyl-N-nitro-guanidine), in or on a variety of 
raw agricultutal commodities at levels ranging from 0.02 ppm to 1.5 ppm 
including barley, canola, cotton, sorghum, wheat, cucurbit vegetables, 
fruiting vegetables, pome fruits and livestock commodities. Pending 
tolerances include coffee, grapes, raisins, grape juice, pecans, peanut 
nutmeats, peanut hay, corn grain, sweet corn (kernal with husk 
removed), pop corn, corn forage and stover, head and stem brassica, 
leafy brassica greens and leafy vegetables.
    i. Food--a. Acute risk. The acute dietary risk from food use 
tolerances previously set as published in the Federal Register of 
December 21, 2000 (65 FR 80343) (FRL-6758-1) and May 23, 2001 (66 FR 
28386) (FRL-6784-7) indicate that acute dietary exposure from food will 
occupy 3% of the acute population adjusted dose (aPAD) for the U.S. 
population, 2% of the aPAD for females 13-50 years old, 8% of the aPAD 
for infants less than 1 year old and 7% of the aPAD for children 6-11 
years old. Therefore, it is expected that the proposed tolerances for 
coffee will have minimal impact on acute dietary risk, and that the 
aggregate exposure will not exceed 100% of the aPAD.
    b. Chronic risk. The chronic dietary risk from food use tolerances 
previously set as published in the Federal Register of December 21, 
2000 (65 FR 80343), and May 23, 2001 (66 FR 28386) indicate that 
chronic dietary exposure from food will utilize 5% of the chronic 
population adjusted dose (cPAD) for the U.S. population, 13% of the 
cPAD for children 1-6 years old. Therefore, it is expected that the 
proposed tolerances for coffee will have minimal impact on chronic 
dietary risk and the aggregate exposure will not exceed 100% of the 
cPAD.
    c. Cancer risk. Since there were no detectable residues of 
thiamethoxam or its metabolite in samples from the residue trials 
conducted in Brazil, Columbia and Mexico, it can be concluded that 
there is no increased cancer risk from the proposed use on imported 
coffee. Syngenta DEEM analysis indicates that the proposed tolerance on 
coffee contributes only 3.00 x 10E-9 lifetime dietary cancer 
risk.
    ii. Drinking water. Since the proposed tolerance is for imported 
coffee, there is no potential exposure from drinking water.
    2. Non-dietary exposure. Thiamethoxam is not currently registered 
for use on any sites that would result in residential exposure.

D. Cumulative Effects

     The potential for cumulative effects of thiamethoxam, and other 
substances that have a common mechanism of toxicity has also been 
considered. Thiamethoxam belongs to a new pesticide chemical class 
known as the neonicotinoids. There is no reliable information to 
indicate that toxic effects produced by thiamethoxam would be 
cumulative with those of any other chemical including another 
pesticide. Therefore, Syngenta believes it is appropriate to consider 
only the potential risks of thiamethoxam in an aggregate risk 
assessment.

E. Safety Determination

    1. U.S. population. Syngenta concludes, as described above, that 
there is reasonable certainty that no harm to the U.S. population will 
result from aggregate acute or chronic dietary exposure to thiamethoxam 
residues including the proposed tolerances for imported coffee.
    2. Infants and children. Syngenta concludes, as described above, 
that there is reasonable certainty that no harm to infants and children 
will result from aggregate acute or chronic exposure to thiamethoxam 
residues, including the proposed tolerances for imported coffee.

[[Page 64832]]

F. International Tolerances

     There are no Codex maximum residue levels established for residues 
of thiamethoxam on coffee.
[FR Doc. 01-30915 Filed 12-13-01; 8:45 am]
BILLING CODE 6560-50-S