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sulfosate (touchdown) Pesticide Petition Filing 4/99



[Federal Register: April 8, 1999 (Volume 64, Number 67)]
[Notices]               
[Page 17171-17179]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap99-86]

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ENVIRONMENTAL PROTECTION AGENCY

[PF-869; FRL-6071-2]

 
Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of pesticide 
petitions 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-869, must 
be received on or before May 10, 1999.

ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), 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-
docket@epamail.epa.gov. 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: The product manager listed in the 
table below:

------------------------------------------------------------------------
                                   Office location/
        Product Manager            telephone number          Address
------------------------------------------------------------------------
Sidney Jackson................  Rm. 272, CM #2, 703-    1921 Jefferson
                                 305-7610, e-            Davis Hwy,
                                 mail:jackson.sidney@e   Arlington, VA
                                 pamail.epa.gov.
Lisa D. Jones.................  Rm. 259, CM #2, 703-    Do.
                                 308-9424, e-
                                 mail:jones.lisa@epama
                                 il.epa.gov. #
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SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions 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 these petitions 
contain 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.
    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-869] (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:
    opp-docket@epamail.epa.gov


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comments and data 
will also be accepted on disks in Wordperfect 5.1 file format or ASCII 
file format. All comments and data in electronic form must be 
identified by the docket number (insert docket number) and appropriate 
petition number. Electronic comments on 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: April 2, 1999.


onald R. Stubbs, Acting

Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    Petitioner summaries of the pesticide petitions are printed below 
as required by section 408(d)(3) of the FFDCA. The summaries of the 
petitions were prepared by the petitioners and represent the views of 
the petitioners. EPA is publishing the petition summaries verbatim 
without editing them in any way. The petition summary announces the 
availability of a description of the analytical methods

[[Page 17172]]

available to EPA for the detection and measurement of the pesticide 
chemical residues or an explanation of why no such method is needed.


3. Zeneca Ag. Products

 PP 7F4854, 7F4876, and 7F4853

    EPA has received pesticide petitions [7F4854, 7F876, and 7F4853] 
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 (FFDCA), 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) the 
fruiting vegetables (except cucurbits) group at 0.05 ppm; the edible-
podded legume vegetables subgroup at 0.5 ppm (of which no more than 0.3 
ppm is trimethylsulfonium (TMS)), the succulent shelled pea and bean 
subgroup at 0.2 ppm (of which no more than 0.1 ppm is TMS); the dried 
shelled pea and bean (except soybean) subgroup at 6 ppm (of which no 
more than 1.5 ppm is TMS); in cattle, goat, hog, sheep, and horse 
kidney at 3.5 ppm; in cattle, goat, hog, sheep, and horse meat by-
products, except liver and kidney, at 2.5 ppm; and to increase the 
tolerance in cattle, goat, hog, sheep, and horse fat to 0.2 ppm; in 
cattle, goat, hog, sheep, and horse meat to 0.6 ppm; in cattle, goat, 
hog, sheep, and horse liver to 0.75 ppm; in milk to 1.1 ppm; in poultry 
liver to 0.1 ppm; in poultry meat by-products to 0.25 ppm; in or on 
soybean seed to 21 ppm (of which no more than 13 ppm is TMS); in 
soybean hulls to 45 ppm (of which no more than 25 ppm is TMS); and in 
aspirated grain fractions to 1,300 ppm (of which no more than 720 ppm 
is TMS) at 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 
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 only residues of concern 
are the parent ionsN-(phosphonomethyl)-glycine anion (PMG) and 
trimethylsulfonium cation (TMS).
    2. Analytical method. Gas chromatography/mass selective (GC/MS) 
detector methods have been developed for PMG analysis in crops, animal 
tissues, milk, and eggs. Gas chromatography detection methods have been 
developed for TMS in crops, animal tissues, milk, and eggs.
    3. Magnitude of residues--i. Magnitude of residues in crops-- 
Soybeans. Residue data are available for sulfosate in a total of 20 
trials conducted in 3 different EPA regions and 15 different States 
representing 99% of the soybean production in the U.S. The proposed 
tolerance of 21 ppm (of which no more than 13 ppm is TMS) for soybean 
seed will accommodate any residue resulting from the proposed use 
pattern.
    Soybean seed for processing were obtained and samples were 
processed into hulls, meal, crude oil, refined oil, and soapstock. 
Aspirated grain fractions were also collected. Analysis of the treated 
samples showed that residue of both TMS and PMG accumulated in hulls 
but did not accumulate in any other processed fractions. The proposed 
tolerance of 45 ppm (of which no more than 25 ppm is TMS) for soybean 
hulls and 1,300 ppm (of which no more than 720 ppm is TMS) for 
aspirated grain fractions will accommodate any residue resulting from 
the proposed use pattern.
    ii. Fruiting vegetables (except curcurbits) group. Residue data are 
available for sulfosate in a total of 12 trials in tomatoes conducted 
in 5 EPA regions and 5 different states; a total of 6 trials in bell 
peppers conducted in 5 EPA regions and 6 different States; and a total 
of 3 trials in chili peppers conducted in 3 EPA regions and 3 different 
States. The residue levels were below the limit of quantitation (LOQ) 
of 0.05 ppm in all samples. The proposed tolerance of 0.05 ppm will 
accommodate any residue resulting from the proposed use pattern.
    Tomato fruits for processing were obtained and samples were 
processed into puree and paste. After adjusting the results for the 
exaggerated rate, no concentration occurred in the puree and paste. No 
tolerances are required for puree and paste at the proposed use rates.
    iii. Edible podded legume vegetables subgroup. Residue data are 
available for sulfosate in a total of 9 trials conducted in 5 different 
EPA regions and 8 different States representing 94% of the edible 
podded beans and peas in the U.S. The proposed tolerance of 0.5 ppm (of 
which no more than 0.3 ppm is TMS) for the Edible podded legume 
vegetables subgroup will accommodate any residue resulting from the 
proposed use pattern.
    iv. Succulent shelled pea and bean subgroup. Residue data are 
available for sulfosate in a total of 12 trials in 6 different EPA 
regions and 10 different States representing 97% of the green peas and 
lima beans in the United States. The proposed tolerance of 0.2 ppm (of 
which no more than 0.1 ppm is TMS) for the Succulent shelled pea and 
bean subgroup will accommodate any residue resulting from the proposed 
use pattern.

[[Page 17177]]

    v. Dried shelled pea and bean (except soybean) subgroup. Residue 
data are available for sulfosate in a total of 14 trials conducted in 5 
different EPA Regions and in 8 States representing 97% of dried pea and 
96% of dried bean production in the United States. The proposed 
tolerance of 6 ppm (of which no more than 1.5 ppm is TMS) for the Dried 
shelled pea and bean (except soybean) subgroup will accommodate any 
residue resulting from the proposed use pattern.
    vi. Magnitude of residue in animals--Ruminants. The maximum dietary 
burden in dairy cows results from a diet comprised of 20% aspirated 
grain fractions, 60% wheat forage, and 20% wheat hay for a total 
dietary burden of 409 ppm. The maximum dietary burden in beef cows 
results from a diet comprised of 20% aspirated grain fractions, 25% 
wheat forage, 25% wheat hay, 20% soybean hulls, and 10% soybean seed 
for a total dietary burden of 378 ppm. Comparison to a ruminant feeding 
study at a dosing level of 300 ppm indicates that the appropriate 
tolerance levels are 0.75 ppm in cattle, goat, hog, sheep, and horse 
liver; 3.5 ppm in cattle, goat, hog, sheep, and horse kidney; 2.5 ppm 
in cattle, goat, hog, sheep, and horse meat by-products, except kidney 
and liver; 0.6 ppm in cattle, goat, hog, sheep, and horse meat; 1.1 ppm 
in milk; and 0.2 ppm in cattle, goat, hog, sheep, and horse fat. All of 
these tolerances exceed existing tolerances in 40 CFR 180.489.
    vii. Poultry. The maximum dietary burden in poultry results from a 
diet comprised of 40% soybean meal, 20% soybean hulls, 20% soybean 
seed, and 20% wheat milled by-products for a total dietary burden of 24 
ppm. Comparison to a poultry feeding study at a dosing level of 50 ppm 
indicates that the appropriate tolerance levels are below established 
tolerances for poultry meat, fat, and eggs. The appropriate tolerance 
for poultry liver is 0.1 ppm and for poultry meat by-products is 0.25 
ppm.

B. Toxicological Profile

    1. Acute toxicity. Several acute toxicology studies have been 
conducted placing technical grade sulfosate in Toxicity Category III 
and IV.
    2. Genotoxicty. 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, 4.2., 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 no-observable 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) which 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: (1) 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, (2) 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 conversion factor of 1 mg/kg-day = 20 
ppm). 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 and 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 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 sub-chronic 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

[[Page 17178]]

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, 4.2, 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 (highest dose 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 0.05 ppm for the fruiting vegetables (except 
cucurbits) group; 0.5 ppm for the edible-podded legume vegetables 
subgroup; 0.2 ppm for the succulent shelled pea and bean subgroup; 6 
ppm for the dried shelled pea and bean (except soybean) subgroup; 3.5 
ppm for cattle, goat, hog, sheep, and horse kidney; 2.5 ppm for cattle, 
goat, hog, sheep, and horse meat by-products, except liver and kidney; 
0.6 ppm for cattle, goat, hog, sheep, and horse meat; 0.75 ppm for 
cattle, goat, hog, sheep, and horse liver; 1.1 ppm for milk; 0.1 ppm 
for poultry liver; 0.25 ppm for poultry meat by-products; 21 ppm for 
soybean seed; 45 ppm for soybean hulls; 1300 ppm for aspirated grain 
fractions; 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 overestimate 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 mg/kg bwt/day (7.4% of 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%) 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%).
    iii. 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 Generic Expected Environmental Concentration (GENEEC). 
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. 
Drinking water levels of concern (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 
7,700 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 ppb) 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.
    2. Non-dietary exposure. Sulfosate is currently not registered for 
use on any residential non-food sites. Therefore, 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 U.S. 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

[[Page 17179]]

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 U.S. 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. 99-8775 Filed 4-7-99; 8:45 am]
BILLING CODE 6560-50-F