[Federal Register Volume 64, Number 12 (Wednesday, January 20, 1999)]
[Notices]
[Pages 3099-3102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1120]



[[Page 3099]]

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ENVIRONMENTAL PROTECTION AGENCY

[PF-852; FRL-6053-5]


Notice of Filing of a Pesticide Petition

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 
certain pesticide chemicals in or on various food commodities.
DATES: Comments, identified by the docket control number PF-852, must 
be received on or before February 19, 1999.
ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch (7502C), Information Resources and Services 
Division, Office of Pesticides Programs, Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. In person bring comments 
to: Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically to: opp-
[email protected]. Follow the instructions under ``SUPPLEMENTARY 
INFORMATION.'' No confidential business information should be submitted 
through e-mail.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). CBI should not be 
submitted through e-mail. Information marked as CBI will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2. A copy of the comment that does not contain CBI must be submitted 
for inclusion in the public record. Information not marked confidential 
may be disclosed publicly by EPA without prior notice. All written 
comments will be available for public inspection in Rm. 119 at the 
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: James Tompkins, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: Rm. 239, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-5697; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition as 
follows proposing the establishment and/or amendment of regulations for 
residues of certain pesticide chemicals in or on various food 
commodities under section 408 of the Federal Food, Drug, and Comestic 
Act (FFDCA), 21 U.S.C. 346a. EPA has determined that the 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 supports 
granting of the petition. Additional data may be needed before EPA 
rules on the petition.
    The official record for this notice of filing, as well as the 
public version, has been established for this notice of filing under 
docket control number [PF-852] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The official record is located at the address in 
``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket control number [PF-852] and appropriate petition number. 
Electronic comments on this notice may be filed online at many Federal 
Depository Libraries.

List of Subjects

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

    Dated: December 23, 1998.

James Jones,

Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    Petitioner summary of the pesticide petition is printed below as 
required by section 408(d)(3) of the FFDCA. The summary of the petition 
was prepared by the petitioner and represents the view of the 
petitioner. 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.

Zeneca Ag. Products

PP 5F4554

    EPA has received a pesticide petition (PP 5F4554) from Zeneca Ag. 
Products, 1800 Concord Pike, P. O. Box 15458, Wilmington, DE 19850-
5458, proposing pursuant to section 408(d) of the Federal Food, Drug, 
and Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by 
establishing a tolerance for residues of sulfosate (the 
trimethylsulfonium salt of glyphosate, also known as glyphosate-
trimesium in or on the raw agricultural commodity (RAC) wheat bran at 
2.5 parts per million (ppm) (of which no more than 0.75 ppm is 
trimethylsulfonium (TMS)), wheat grain at 0.75 ppm (of which no more 
than 0.25 ppm is TMS), wheat forage at 35 ppm (of which no more than 30 
ppm is TMS), wheat hay at 85 ppm (of which no more than 80 ppm is TMS), 
wheat shorts at 1.5 ppm (of which no more than 0.5 ppm is TMS), wheat 
straw at 1.0 ppm (of which no more than 0.5 ppm is TMS), the pome fruit 
group at 0.05 ppm; in cattle, goat, hog, sheep, and horse liver at 0.5 
ppm, in cattle, goat, hog, sheep, and horse meat by-products, except 
liver at 2.5 ppm; to increase the tolerance in cattle, goat, hog, 
sheep, and horse meat from 0.2 to 0.4 ppm and in milk from 0.2 to 0.5 
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 supports granting of the 
petition. Additional data may be needed before EPA rules on the 
petition.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of sulfosate has been studied 
in corn, grapes, and soybeans. EPA has concluded that the nature of the 
residue is adequately understood and that the residues of concern are 
the parentions only N-(phosphonomethyl)-glycine anion (PMG) and 
trimethylsulfonium cation (TMS).
    2. Analytical method. Gas chromatography/mass selective detector 
methods have been developed for PMG analysis in crops, animal tissues, 
milk, and eggs. Gas chromatography detection

[[Page 3100]]

methods have been developed for TMS in crops, animal tissues, milk, and 
eggs.
    3. Magnitude of residues in crops-- i. Wheat. A total of 15 field 
residue trials were conducted in 14 different states accounting for 77% 
of the total U.S. wheat acreage. These trials were located in Regions 2 
(1 trial), 4 (1 trial), 5 (6 trials), 8 (3 trials), 10 (1 trial) and 11 
(3 trials). Applications in the trials were consistent with the 
requested label directions for use. Analysis of the treated samples 
showed that the maximum PMG residue was 1.47 ppm in forage, 0.34 ppm in 
grain, and 0.38 ppm in straw. The maximum TMS residue was 25.1 ppm in 
forage, 0.21 ppm in grain and 0.4 ppm in straw. Residue data are not 
available for wheat hay, but can be estimated using the forage residue 
data and a dry-down factor of 3.
    Wheat grain for processing was obtained and samples were processed 
into bran, middlings, shorts, flour and aspirated grain fractions. 
Analysis of the treated samples showed that residue of both TMS and PMG 
concentrated in bran and shorts. The appropriate concentration factors 
for bran are 3.1x (PMG), and 2.1x (TMS); and for shorts are 2.0x (PMG), 
and 1.8x (TMS). The residues in the wheat aspirated grain fraction are 
less than the tolerance already established for aspirated grain 
fractions, so no tolerance action is required.
    ii. Pome fruit group. A total of 15 field residue trials (nine 
apple and six pear) were conducted in seven different States, 
accounting for 78 and 99% of the total U.S. apple, and pear production, 
respectively. Harvested fruit had residues of PMG and TMS that were 
<0.05 ppm in all samples. The residue data support the proposed 
tolerance of 0.05 ppm for pome fruit.
    Apples were processed from a trial treated at an exagerrated rate. 
The samples were processed into wet pomace, dry pomace and juice. 
Analysis of the treated samples showed that residues of both TMS and 
PMG were <0.05 ppm in the RAC and all processed fractions. No tolerance 
action for apple processed products is required.
    4. Magnitude of residue in animals-- i. Ruminants. The maximum 
dietary burden in dairy cows results from a diet comprised of 20% 
aspirated grain fractions, 60% wheat forage, and 20% soybean seed/meal 
for a total dietary burden of 134 ppm. The maximum dietary burden in 
beef cows results from a diet comprised of 20% aspirated grain 
fractions, 25% wheat forage, 25% wheat hay, 10% wheat straw, and 20% 
soybean seed/meal for a total dietary burden of 122 ppm. Comparison to 
a ruminant feeding study at a dosing level of 300 ppm indicates that 
the appropriate tolerance levels would be 0.5 ppm in cattle, goat, hog, 
sheep, and horse liver; 2.5ppm in cattle, goat, hog, sheep, and horse 
meat by-products, except liver; 0.4 ppm in cattle, goat, hog, sheep, 
and horse meat; 0.5 ppm in milk; and 0.1 ppm in cattle, goat, hog, 
sheep, and horse fat. All of these tolerances exceed existing 
tolerances in 40 CFR 180.489, except fat.
    ii. Poultry. The maximum poultry dietary burden results from a diet 
comprised of 80% wheat grain and 20% wheat milled by-products for a 
total dietary burden of 1.5 ppm. Comparison to a poultry feeding study 
at a dosing level of 5 ppm indicates that the appropriate tolerance 
levels would be below the established tolerances for poultry meat, meat 
by-products, fat, and eggs.

B. Toxicological Profile

    1. Acute toxicity. Several acute toxicology studies have been 
conducted placing technical grade sulfosate in Toxicity Category III 
and IV.
    2. Genotoxicity. Mutagenicity data includes two Ames tests with 
Salmonella typhimurium; a sex linked recessive lethal test with 
Drosophila melanoga; a forward mutation (mouse lymphoma) test; an in 
vivo bone marrow cytogenetics test in rats; a micronucleus assay in 
mice; an in vitro chromosomal aberration test in Chinese hamster ovary 
cells (CHO) (no aberrations were observed either with or without S9 
activation and there were no increases in sister chromatid exchanges); 
and a morphological transformation test in mice (all negative). A 
chronic feeding/carcinogenicity study was conducted in male and female 
rats fed dose levels of 0, 100, 500 and 1,000 ppm (0, 4.20, 21.2 or 
41.8 milligram/kilogram/day (mg/kg/day) in males and 0, 5.4, 27.0 or 
55.7 mg/kg/day in females). No carcinogenic effects were observed under 
the conditions of the study. The systemic no-observed adverse effect 
level (NOAEL) of 1,000 ppm (41.1/55.7 mg/kg/day for males and females, 
respectively) was based on decreased body weight gains (considered 
secondary to reduced food consumption) and increased incidences of 
chronic laryngeal and nasopharyngeal inflammation (males). A chronic 
feeding/carcinogenicity study was conducted in male and female mice fed 
dosage levels of 0, 100, 1,000, and 8,000 ppm (0, 11.7, 118 or 991 mg/
kg/day in males and 0, 16, 159 or 1,341 mg/kg/day in females). No 
carcinogenic effects were observed under the conditions of the study at 
dose levels up to and including the 8,000 ppm highest dose tested (HDT) 
may have been excessive). The systemic NOAEL was 1,000 ppm based on 
decreases in body weight and feed consumption (both sexes) and 
increased incidences of duodenal epithelial hyperplasia (females only). 
Sulfosate is classified as a Group E carcinogen based on no evidence of 
carcinogenicity in rat, and mouse studies.
    3. Reproductive and developmental toxicity. A developmental 
toxicity study in rats was conducted at doses of 0, 30, 100 and 333 mg/
kg/day. The maternal (systemic) NOAEL was 100 mg/kg/day, based on 
decreased body weight gain and food consumption, and clinical signs 
(salivation, chromorhinorrhea, and lethargy) seen at 333 mg/kg/day. The 
reproductive NOAEL was 100 mg/kg/day, based on decreased mean pup 
weight. The decreased pup weight is a direct result of the maternal 
toxicity. A developmental toxicity study was conducted in rabbits at 
doses of 0, 10, 40 and 100 mg/kg/day with developmental and maternal 
toxicity NOAELs of 40 mg/kg/day based on the following: (i) Maternal 
effects: 6 of 17 dams died (2 of the 4 non-gravid dams); 4 of 11 dams 
aborted; clinical signs - higher incidence and earlier onset of 
diarrhea, anorexia, decreased body weight gain and food consumption; 
and (ii) Fetal effects: decreased litter sizes due to increased post-
implantation loss, seen at 100 mg/kg/day HDT. The fetal effects were 
clearly a result of significant maternal toxicity. A 2-generation 
reproduction study in rats fed dosage rates of 0, 150, 800 and 2,000 
ppm (equivalent to calculated doses of 0, 7.5, 40, and 100 mg/kg/day 
for males and females, based on a factor of 20). The maternal 
(systemic) NOAEL was 150 ppm (7.5 mg/kg/day), based on decreases in 
body weight and body weight gains accompanied by decreased food 
consumption, and reduced absolute and sometimes relative organ (thymus, 
heart, kidney & liver) weights seen at 800 and 2,000 ppm (40 and 100 
mg/kg/day). The reproductive NOAEL was 150 ppm (7.5 mg/kg/day), based 
on decreased mean pup weights during lactation (after day 7) in the 
second litters at 800 ppm (40 mg/kg/day) and in all litters at 2,000 
ppm (100 mg/kg/day), and decreased litter size in the F0a and F1b 
litters at 2,000 ppm (100 mg/kg/day). The statistically significant 
decreases in pup weights at the 800 ppm level were borderline 
biologically significant because at no time were either the body 
weights or body weight gains less than 90% of the control values and 
because the effect was not

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apparent in all litters. Both the slight reductions in litter size at 
2,000 ppm and the reductions in pup weights at 800 and 2,000 ppm appear 
to be secondary to the health of the dams. There was no evidence of 
altered intrauterine development, increased stillborns, or pup 
anomalies. The effects are a result of feed palatability leading to 
reduced food consumption and decreases in body weight gains in the 
dams.
    4. Subchronic toxicity. Two subchronic 90 day feeding studies with 
dogs and a 1-year feeding study in dogs have been conducted. In the 1-
year study dogs were fed 0, 2, 10 or 50 mg/kg/day. The NOAEL was 
determined to be 10 mg/kg/day based on decreases in lactate 
dehydrogenase (LDH) at 50 mg/kg/day. In the first 90 day study, dogs 
were fed dosage levels of 0, 2, 10 and 50 mg/kg/day. The NOAEL in this 
study was 10 mg/kg/day based on transient salivation, and increased 
frequency and earlier onset of emesis in both sexes at 50 mg/kg/day. A 
second 90 day feeding study with dogs dosed at 0, 10, 25 and 50 mg/kg/
day was conducted to refine the threshold of effects. There was 
evidence of toxicity at the top dose of 50 mg/kg/day with a NOAEL of 25 
mg/kg/day. Adverse effects from oral exposure to sulfosate occur at or 
above 50 mg/kg/day. These effects consist primarily of transient 
salivation, which is regarded as a pharmacological rather than 
toxicological effect, emesis and non-biologically significant 
hematological changes. Exposures at or below 25 mg/kg/day have not 
resulted in significant biological adverse effects. In addition, a 
comparison of data from the 90 day and 1-year studies indicates that 
there is no evidence for increased toxicity with time. The overall 
NOAEL in the dog is 25 mg/kg/day.
    5. Chronic toxicity. A chronic feeding/carcinogenicity study was 
conducted in male and female rats fed dose levels of 0, 100, 500 and 
1,000 ppm (0, 4.20, 21.2 or 41.8 mg/kg/day in males, and 0, 5.4, 27.0 
or 55.7 mg/kg day in females). No carcinogenic effects were observed 
under the conditions of the study. The systemic NOAEL of 1,000 ppm 
(41.1/55.7 mg/kg/day for males, and females, respectively) was based on 
decreased body weight gains (considered secondary to reduced food 
consumption) and increased incidences of chronic laryngeal and 
nasopharyngeal inflammation (males). A chronic feeding/carcinogenicity 
study was conducted in male and female mice fed dosage levels of 0, 
100, 1,000 and 8,000 ppm (0, 11.7, 118 or 991 mg/kg/day in males and 0, 
16,159 or 1,341 mg/kg/day in females). No carcinogenic effects were 
observed under the conditions of the study at dose levels up to and 
including the 8,000 ppm (HDT may have been excessive). The systemic 
NOAEL was 1,000 ppm based on decreases in body weight and feed 
consumption (both sexes) and increased incidences of duodenal 
epithelial hyperplasia (females only). Sulfosate is classified as a 
Group E carcinogen based on no evidence of carcinogenicity in rat and 
mouse studies.
    6. Animal metabolism. The metabolism of sulfosate has been studied 
in animals. The residues of concern for sulfosate in meat, milk, and 
eggs are the parent ions PMG and TMS only.
    7. Metabolite toxicology. There are no metabolites of toxicological 
concern. Only the parent ions, PMG and TMS are of toxicological 
concern.
    8. Endocrine disruption. Current data suggest that sulfosate is not 
an endocrine disruptor.

C. Aggregate Exposure

    1. Dietary exposure-- i.Food. For the purposes of assessing the 
potential dietary exposure, Zeneca has utilized the tolerance level for 
all existing and pending tolerances; and the proposed maximum 
permissible levels of 0.75 ppm for wheat grain; 2.5 ppm for wheat bran; 
1.5 ppm for wheat shorts; 0.05 ppm for the pome fruit group; 0.5 ppm 
for cattle, goat, hog, sheep, and horse liver; 2.5 ppm for cattle, 
goat, hog, sheep, and horse meat by-products, except liver; 0.4 ppm for 
cattle, goat, hog, sheep, and horse meat; 0.5 ppm in milk, and 100% 
crop treated acreage for all commodities. Assuming that 100% of foods, 
meat, eggs, and milk products will contain sulfosate residues and those 
residues will be at the level of the tolerance results in an over 
estimate of human exposure. This is a very conservative approach to 
exposure assessment.
    ii. Chronic exposure. For all existing tolerances and pending 
tolerances; and the proposed maximum permissible levels proposed in 
this notice of filing, the potential exposure for the U.S. population 
is 0.018 milligram/kilogram body weight/day (mg/kg/bwt/day) (7.4% of 
reference dose (RfD)). Potential exposure for children's population 
subgroups range from 0.015 mg/kg bwt/day (6.1% of RfD) for nursing 
infants (<1 year old) to 0.076 mg/kg bwt/day (30.5%) for non-nursing 
infants. The chronic dietary risk due to food does not exceed the level 
of concern (100%).
    iii. Acute exposure. The exposure to the most sensitive population 
subgroup, in this instance non-nursing infants, was 23.2% of the acute 
RfD. The acute dietary risk due to food does not exceed the level of 
concern (100%).
    2. Drinking water. Results from computer modeling indicate that 
sulfosate in groundwater will not contribute significant residues in 
drinking water as a result of sulfosate use at the recommended maximum 
annual application rate (4.00 lbs. a.i. acre -1). The 
computer model uses conservative numbers, therefore it is unlikely that 
groundwater concentrations would exceed the estimated concentration of 
0.00224 parts per billion (ppb), and sulfosate should not pose a threat 
to ground water.
    The surface water estimates are based on an exposure modeling 
procedure called GENEEC (Generic Expected Environmental Concentration). 
The assumptions of 1 application of 4.00 lbs. a.i. acre -1 
resulted in calculated estimated maximum concentrations of 64 ppb 
(acute, based on the highest 56 day value) and 43 ppb (chronic, 
average). GENEEC modeling procedures assumed that sulfosate was applied 
to a 10-hectare field that drained into a 1-hectare pond, 2-meters deep 
with no outlet.
    As a conservative assumption, because sulfosate residues in ground 
water are expected to be insignificant compared to surface water, it 
has been assumed that 100% of drinking water consumed was derived from 
surface water in all drinking water exposure and risk calculations.
    To calculate the maximum acceptable acute and chronic exposures to 
sulfosate in drinking water, the dietary food exposure (acute or 
chronic) was subtracted from the appropriate (acute or chronic) RfD. 
DWLOCs were then calculated using the maximum acceptable acute or 
chronic exposure, default body weights (70 kg - adult, 10 kg - child), 
and drinking water consumption figures (2 liters - adult, 1 liter - 
child).
    The maximum concentration of sulfosate in surface water is 64 ppb. 
The acute DWLOCs for sulfosate in surface water were all greater than 
7700 ppb. The estimated average concentration of sulfosate in surface 
water is 43 ppb which is much less than the calculated levels of 
concern (>1,700) in drinking water as a contribution to chronic 
aggregate exposure. Therefore, for current and proposed uses of 
sulfosate, Zeneca concludes with reasonable certainty that residues of 
sulfosate in drinking water would not result in unacceptable levels of 
aggregate human health risk.
    3. Non-dietary exposure. Sulfosate is currently not registered for 
use on any residential non-food sites. Therefore,

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residential exposure to sulfosate residues will be through dietary 
exposure only.

D. Cumulative Effects

    There is no information to indicate that toxic effects produced by 
sulfosate are cumulative with those of any other chemical compound.

E. Safety Determination

    1. U.S. population-- i. Acute risk. Since there are no residential 
uses for sulfosate, the acute aggregate exposure only includes food and 
water. Using the conservative assumptions of 100% of all crops treated 
and assuming all residues are at the tolerance level for all 
established and proposed tolerances, the aggregate exposure to 
sulfosate will utilize 17.3% of the acute RfD for the US population. 
The estimated peak concentrations of sulfosate in surface and ground 
water are less than DWLOCs for sulfosate in drinking water as a 
contribution to acute aggregate exposure. Residues of sulfosate in 
drinking water do not contribute significantly to the aggregate acute 
human health risk considering the present uses and uses proposed in 
this action.
    ii. Chronic risk. Using the conservative exposure assumptions 
described above, the aggregate exposure to sulfosate from food will 
utilize 7.4% of the chronic RfD for the US population. The estimated 
average concentrations of sulfosate in surface and ground water are 
less than DWLOCs for sulfosate in drinking water as a contribution to 
chronic aggregate exposure. Residues of sulfosate in drinking water do 
not contribute significantly to the aggregate chronic human health risk 
considering the present uses and uses proposed in this action.
    2. Infants and children. The database on sulfosate relative to pre- 
and post-natal toxicity is complete. Because the developmental and 
reproductive effects occurred in the presence of parental (systemic) 
toxicity, these data do not suggest an increased pre- or post-natal 
sensitivity of children and infants to sulfosate exposure. Therefore, 
Zeneca concludes, upon the basis of reliable data, that a 100-fold 
uncertainty factor is adequate to protect the safety of infants and 
children and an additional safety factor is unwarranted.
    i. Acute risk. Using the conservative exposure assumptions 
described above, the aggregate exposure to sulfosate from food will 
utilize 23.2% of the acute RfD for the most highly exposed group, non-
nursing infants. The estimated peak concentrations of sulfosate in 
surface and ground water are less than DWLOCs for sulfosate in drinking 
water as a contribution to acute aggregate exposure. Residues of 
sulfosate in drinking water do not contribute significantly to the 
aggregate acute human health risk considering the present uses and uses 
proposed in this action.
    ii. Chronic risk. Using the conservative exposure assumptions 
described above, we conclude that the percent of the RfD that will be 
utilized by aggregate exposure to residues of sulfosate is 30.5% for 
non-nursing infants, the most highly exposed group. The estimated 
average concentrations of sulfosate in surface and ground water are 
less than DWLOCs for sulfosate in drinking water as a contribution to 
chronic aggregate exposure. Residues of sulfosate in drinking water do 
not contribute significantly to the aggregate chronic human health risk 
considering the present uses and uses proposed in this action.

F. International Tolerances

    There are no Codex Maximum Residue Levels established for 
sulfosate.

[FR Doc. 99-1120 Filed 1-19-99; 8:45 am]
BILLING CODE 6560-50-F