Notice of Filing of a Pesticide Petition
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: January 20, 1999 (Volume 64, Number 12)]
[Notices]
[Page 3099-3102]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ja99-68]
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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-
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: 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:
tompkins.jim@epamail.epa.gov.
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:
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. 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
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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 <SUP>-1</SUP>). 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 <SUP>-1</SUP>
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
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