Foramsulfuron - Pesticide Petition Filing 1/01
ENVIRONMENTAL PROTECTION AGENCY
Notice of Filing a Pesticide Petition to Establish a Tolerance
for a Certain Pesticide Chemical in or on Food
AGENCY: Environmental Protection Agency (EPA).
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-995, must be
received on or before March 9, 2001.
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-995 in the subject line on the first page of your
FOR FURTHER INFORMATION CONTACT: By mail: Jim Tompkins, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-5697; e-mail address: firstname.lastname@example.org.
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:
Categories NAICS codes potentially
Industry 111 Crop production
112 Animal production
311 Food 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
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-995. 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.
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-995 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@example.com, 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-995. 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
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
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
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
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
Dated: January 25, 2001.
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 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.
EPA has received a pesticide petition (0F6161) from Aventis
CropScience USA LP, P.O. Box 12014, 2 T.W. Alexander Drive, Research
Triangle Park, NC 27709 proposing, pursuant to section 408(d) of the
FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing
tolerances for residues of 2-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]
carbonyl] amino] sulfonyl]-4-(formylamino)-N, N-dimethylbenzamide (CAS
#173159-57-4)(foramsulfuron, company code AE F130360) in or on the raw
agricultural commodities (RAC) corn grain at 0.02 parts per million
(ppm), and corn forage and corn stover at 0.1 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 metabolism of foramsulfuron in corn has
been investigated and is understood. Two primary routes of degradation
occur for foramsulfuron. One pathway involves the hydrolysis of the
sulfonylurea bridge, resulting in AE F153745 (4-formylamino-N, N-
dimethyl-2-sulfamoylbenzamide) and AE F092944 (2-amino-4,6-
dimethoxypyrimidine). Foramsulfuron also hydrolyzes at the formamide
moiety on the phenyl ring to produce AE F130619 (4-amino-2-[3-(4,6-
dimethoxypyrimidin-2-yl)ureidosulfonyl]-N, N-dimethylbenzamide). All
these metabolites are subjected to further degradation leading to the
formation of highly polar, water soluble components. The two
metabolites resulting from cleavage of the sulfonylurea bridge, namely
AE F153745 and AE F092944 were found in the extractable residue of the
forage and stover. Only traces of AE F130619 (from hydrolysis of the
formamide moiety) were found also in the forage and stover. The major
metabolite detected in plants (AE F153745) was also identified in the
rat and livestock metabolism studies.
2. Analytical method. Based on the results of the metabolism
studies, the analytical targets selected were parent compound (AE
F130360) and the metabolite AE F153745. Extractable residues of
foramsulfuron and AE F153745 are removed from the crop matrix by
blending with aqueous acetonitrile. After filtration, the extract is
rotary evaporated down to a reduced volume. The aqueous/organic extract
is transferred to a separatory funnel and washed with hexane. After the
hexane wash, the extract is cleaned up via special column
chromatography then analyzed by high performance liquid chromotography/
mass spectrometry (HPLC/MS).
3. Magnitude of residues. The metabolism studies with
14C-labelled foramsulfuron in corn using exaggerated
application rates (over 2.5-fold the normal rate) demonstrated that in
general, low residues were detected in the plant samples. These results
have been confirmed in a total of 29 North American residue field
trials using a water dispersible granule (WG) formulation containing
50% weight/weight (w/w) foramsulfuron. The preparation was applied in
split applications. The predominant regimen was 30 gram/health
advisories (g/ha) followed by 60 g/ha or alternatively, 2 times 45 g/
ha. Pre-harvest intervals (PHI) were between 37 and 67 days, 60 and 121
days or 67 and 151 days respectively for forage, grain, or stover.
Grain, stover, and forage of field corn did not contain residues of
foramsulfuron at or above the respective limits of quantification (LOQ)
of 0.01, 0.05, and 0.05 milligram/kilogram (mg/kg). Also no residues of
the metabolite AE F153745 were found in corn grain, stover, or forage
at harvest above the respective LOQ of 0.02, 0.05, and 0.05 mg/kg.
Residues trials included testing the effects of adding typical non-
ionic surfactants, esterified seed oils, or crop oil concentrates to
the spray mix. In no case were residues above the LOQ observed.
Although AE F153745 was the major metabolite detected in the corn
metabolism study, it did not exceed 10% of the total formasulfuron-
derived residue in grain, stover, or forage at harvest. It is proposed,
therefore, that AE F153745 is not included in the tolerance expression
as field trials confirmed its lack of formation at levels above the
LOQ. Tolerances of foramsulfuron are proposed at twice the LOQ of the
analytical method, namely 0.02, 0.1, and 0.1 mg/kg in grain, stover,
and forage, respectively. In a corn processing study, no residues of AE
F130360 above 0.01 mg/kg or AE F153745 above 0.02 mg/kg were observed
in corn grain following treatment of the crop at the nominal rate of
150 followed by 300 g/ha. This exaggerated rate is approximately five
times the maximum proposed label rate. Since no residues were observed
in the RAC, neither analysis of the processed commodities nor
tolerances are required. Although corn grain is fed to cattle, and
poultry and cattle may be grazed on forage, or fed stover, tolerances
in meat, milk, or eggs are not necessary because none of these
commodities contained foramsulfuron or its metabolite.
B. Toxicological Profile
1. Acute toxicity. Foramsulfuron has been shown to have very low
acute toxicity to mammals irrespective of the route of exposure. Only
non-specific clinical signs were seen after oral administration of
5,000 mg/kg to rats and after inhalation exposure of rats to 5.04
milligram/liter (mg/L). These signs had completely resolved 4 days
following oral treatment and by day 1 after inhalation exposure. There
was no evidence of systemic toxicity following acute dermal exposure to
2,000 mg/kg foramsulfuron. It was not irritant to rabbit skin and only
mildly irritating to rabbit eyes. Foramsulfuron did not induce delayed
contact hypersensitivity (skin sensitization) in a Magnusson and
Kligman maximization test. Based on these results, foramsulfuron would
be classified as EPA category III for dermal toxicity and eye
irritation, and EPA category IV for skin irritation, oral, and
2. Genotoxicity. Genotoxic potential was evaluated in a battery of
tests which examined gene mutation in bacteria and mammalian cells,
chromosome damage in vitro and in vivo and DNA damage in mammalian
cells in vivo. The only finding was weak evidence in vitro of
chromosome aberrations in human lymphocytes in the absence of metabolic
activation. The increases in incidences occurred only at the highest
dose level tested, 2,400 µg/mL, and were only just outside the
historical control range. However, there was no evidence of chromosome
damage in vivo, no effects in the in vivo assay for unscheduled DNA
synthesis and no oncogenic activity or developmental toxicity. Thus,
the overall weight of evidence indicates that foramsulfuron does not
possess significant genotoxic activity.
3. Reproductive and developmental toxicity. A 2-generation
reproduction study in rats evaluated continuous dietary dose levels of
0, 100, 1,225, and 15,000 ppm of technical foramsulfuron. No treatment-
related effects were observed, including no effects on reproductive
parameters (fertility, mating, gestation, parturition, litter size sex
ratios), parental toxicity, neonatal toxicity, or on markers of
endocrine function (oestrous cycling, balanopreputial separation,
vaginal opening, spermatogenetic function and capacity). Therefore, the
no observed adverse effect level (NOAEL) was 15,000 ppm, equivalent to
a mean daily intake of 1,038 mg/kg foramsulfuron body weight (bwt) for
F0 and F1 males and 1,430 mg/kg/day for
F0 and F1 females combined (about 1,234 mg/kg/day
for the study overall).
A rat developmental toxicity (teratogenicity) study was conducted
with dose levels of 0, 5, 71, and 1,000 mg/kg foramsulfuron bwt/day.
There was no evidence of any maternal or embryo foetal toxicity up to
and including the 1,000 mg/kg dose level, the international limit dose
for this type of study. Therefore the NOAEL for both maternal and
embryofetal toxicity was 1,000 mg/kg. Foramsulfuron was not teratogenic
The rabbit developmental toxicity (teratogenicity) study was
conducted with dose levels of 0, 5, 50, and 500 mg/kg foramsulfuron
bwt/day. Maternal toxicity was seen at the high dose of 500 mg/kg/day,
as evidenced by reduced body weight gain and slightly decreased food
consumption during the treatment period. There was no embryofetal
toxicity at any dose level. The NOAEL
for maternal toxicity was 50 mg/kg and 500 mg/kg for developmental
toxicity (teratogenicity). Foramsulfuron was not teratogenic in the
Results of the 2-generation and the developmental toxicity
(teratogenicity) studies, show that foramsulfuron gives no evidence of
reproductive, embryofetal, or neonatal toxicity. Parental (maternal)
toxicity was only seen in the rabbit at 1,000 mg/kg, the international
Therefore, foramsulfuron was of very low reproductive toxicity.
4. Subchronic toxicity. In a 90-day rat feeding study, groups of 10
male, and 10 female Sprague Dawley rats were fed diets containing
either 0, 20, 200, 500, or 20,000 ppm of foramsulfuron. There was no
treatment-related mortalities or effects seen at any dose level. The
NOAEL for this study was considered to be 20,000 ppm (approximately
1,677 mg/kg/day which is in excess of the 1,000 mg/kg/day international
In a 90-day feeding study in mice, foramsulfuron was administered
at dietary concentrations of 64, 3,200, and 6,400 ppm. There was no
treatment-related deaths or effects found in mice at any dose level.
The NOAEL for this study was 6,400 ppm (equivalent to 1,002 mg/kg/day
for males and 1,178 mg/kg/day for females).
Groups of 4 males and 4 females Beagle dogs were administered
foramsulfuron at dietary concentrations of 0, 10, 250, and 1,000 mg/kg/
bwt/day for 13 consecutive weeks. There were no mortalities, and no
clinical signs directly related to treatment at any dose level. The
NOAEL for both sexes was 1,000 mg/kg/day, the international limit dose.
5. Chronic toxicity. The oncogenic potential of foramsulfuron was
examined in bioassays with rats and mice with dietary exposure periods
of 2 years and 18 months, respectively.
In rats, dietary administration of up to 20,000 ppm of
foramsulfuron for 2 years, equivalent to achieved intakes of 849 and
1,135 mg/kg/day for males and females, respectively, did not yield any
evidence of toxicity or oncogenicity. The mean daily intakes over the
1-year period were 976 and 1,305 mg/kg/day for males and females,
respectively. Thus this dose level approximated to the international
regulatory limit dose of 1,000 mg/kg/day.
Similarly in mice, no oncogenic activity was found after dietary
treatment with up to 8,000 ppm (equating to 1,115 and 1,358 mg/kg/day
in males and females, respectively) for 18 months, which was slightly
in excess of the international limit dose.
Based on the achieved intakes, the rat is the most sensitive
species in these long-term studies and the overall lowest NOAEL was 849
mg/kg foramsulfuron body weight/day. Given the absence of any
carcinogenicity, significant genotoxicity, reproduction toxicity,
developmental toxicity or any other special hazard potential, and
taking into consideration the low toxicity profile, poor absorption and
rapid excretion (predominantly of parent compound), a safety factor of
100 is considered appropriate. Therefore the proposed reference dose
(RfD) is 8.5 mg/kg bwt/day.
Aventis CropScience believes foramsulfuron should be classified as
a "not likely" carcinogen based on the lack of carcinogenicity in
rats and mice.
6. Animal metabolism. Following a single oral administration of
either 10 or 1,000 mg/kg to rats, 91.5% of the dose was found in the
excreta between 0 and 24 hours post-dosing. There were no sex-specific
differences in the route of excretion, and tissue residues were
generally low. The metabolism of foramsulfuron showed that at both dose
rates the main excretion product was unchanged foramsulfuron, excreted
mainly in the faeces. Two metabolic routes were identified leading to
the formation of metabolites also detected in plants: AE F130619, an
amine formed via hydrolysis at the formamide moiety on the phenyl and
the cleavage product AE F153745, as minor metabolites. A number of
unidentified, minor (<4%), polar metabolites formed from both the
phenyl or pyrimidyl ring-labelled compound were also excreted.
Six laying hens were orally dosed with (U-14C-phenyl)-
foramsulfuron for 14 consecutive days with a mean daily dose of 1.50 mg
per bird per day, equivalent to approximately 10 ppm in the diet. The
levels of radioactive residues in the hen tissues at necropsy were low,
with the highest concentration being found in the liver (0.023
µg equivalents/g). The residues in the muscle, fat, and skin
were all found to be 0.003 µg equivalents/g or less, which is
below the concentration requiring further analysis. The unchanged
parent compound and the cleavage product AE F153745 were the only
metabolites identified in the edible tissues, eggs and excreta, which
are also significant in the cow and rat.
A dairy cow was orally dosed with (U-14C-phenyl)-
foramsulfuron for 7 consecutive days with a mean daily dose of 187.4
mg, equivalent to 16 ppm in the diet. Radioactive residues were
detectable in all edible tissues at very low levels between 0.004 and
0.036 µg equivalents/g tissue at necropsy. The major
metabolites identified in all tissues were unchanged foramsulfuron and
AE F153745. Some very minor metabolites were also seen in the liver and
fat but were not identified. The results show that foramsulfuron is
poorly absorbed and is excreted mainly in the faeces. The only
identifiable metabolic product of foramsulfuron detected in the tissues
and excreta of the dairy cow was AE F153745, which is also the
principal metabolite identified in the hen, rat, and corn.
7. Endocrine disruption. No special studies have been conducted to
investigate the potential of foramsulfuron to induce estrogenic or
other endocrine effects. However, no evidence of estrogenic or other
endocrine effects have been noted in any of the standard toxicology
studies that have been conducted with this product and there is no
reason to suspect that any such effects would be likely.
C. Aggregate Exposure
1. Dietary exposure. Foramsulfuron is proposed for use as an
herbicide on corn. No non-agricultural uses are anticipated. The
potential sources of exposure would consist of any potential residues
in food and drinking water. As indicated above, there are no acute
toxicity concerns and thus only chronic exposure has been evaluated.
i. Food. Chronic dietary analysis was conducted to estimate
exposure to potential foramsulfuron residues in/on corn. A Tier 1
analysis was conducted using the dietary exposure evaluation system
(DEEM™) software and the 1994-1996 CSFII food consumption
data. It was assumed that residues were at tolerance levels of 0.02 ppm
(twice the LOQ) in grain and that 100% of the crop was treated.
Additionally, based on the results from appropriate studies, it was
assumed that there was no concentration into processed commodities and
that contributions from residues in meat, milk, or eggs are not
required. A chronic RfD of 8.5 mg/kg/day is derived from the male rat
NOAEL of 849 mg/kg/day. Using these inputs the chronic dietary exposure
estimate from residues of foramsulfuron for the U.S. population was
0.000032 mg/kg/day or <0.001% of its RfD. For the sub-population with
the highest exposure, non-nursing infants, the chronic dietary exposure
estimate from residues of foramsulfuron was 0.000080 mg/kg/day, again
<0.001% of its RfD. These values are highly conservative, having been
based on worst case assumptions of tolerance level residues and 100% of
the crop treated.
ii. Drinking water. Unites States EPA's standard operating
procedure (SOP) for drinking water exposure and risk assessments was
used to perform the drinking water assessment. This SOP uses a variety
of tools to conduct a screening level drinking water assessment. These
tools include water models such as screening concentration ground water
(SCI-GROW), generic expected environmental concentration (GENEEC),
EPA's pesticide root zone model (PRZMS)/EXAMS, and monitoring data. If
monitoring data is not available then the models are used to predict
potential residues in surface and ground water and the highest value is
assumed to be the potential drinking water residue. In the case of
foramsulfuron monitoring data do not exist therefore model calculations
were used to estimate a water residue. The calculated drinking water
levels of concern (DWLOC) for chronic exposures for adults is 297,498
(ppb) parts per billion (297 ppm). The chronic DWLOC for children/
toddlers is 84,999 ppb (84 ppm). The worst case chronic drinking water
estimated concentration (DWEC) is 0.225 ppb based on a PRZM/EXAMS
simulation of runoff into surface water in a standard EPA exposure
assessment scenario for corn (MLRA 111, Ohio). The calculated DWLOCs
for chronic exposures for all adults and children therefore greatly
exceed the DWECs from the models.
2. Non-dietary exposure. Exposure to foramsulfuron for the mixer/
loader/ground boom/aerial applicator was calculated using the pesticide
handlers exposure data base (PHED). It was assumed that the product
would be applied to a maximum of 50 hectares per day (125 A/day) by
ground boom applicatior and 140 hectares per day (350 A/day) by aerial
applicator at a maximum use rate of 45 grams a.i./ha. Normal work
attire consisting of long-sleeved shirt, long pants, and protective
gloves was assumed in the PHED assessment. Margins of exposure (MOEs)
for a 70 kg operator were calculated utilizing a dermal NOAEL of 1,000
mg/kg bwt/day from the rat dermal toxicity study and an inhalation
NOAEL of 50 mg/kg bwt/day based on an oral administration,
developmental toxicity study in the rabbit. There were no signs of
developmental toxicity in the rabbit developmental toxicity study. The
combined MOE (inhalation plus dermal) for foramsulfuron was 126,000 for
a ground operator undertaking mixing, loading, and spraying. For aerial
application where the mixer/loader was assumed to be a different
operator from the pilot combined MOEs were 60,400 for the mixer/loader
and 1,425,000 for the pilot. The results indicate that large margins of
safety exist for the proposed use of foramsulfuron.
The timing of foramsulfuron application to corn is such that field
reentry shortly after spraying is atypical. Therefore estimations of
worker reentry exposure were not considered necessary.
D. Cumulative Effects
There is no available data at this time to determine whether
foramsulfuron has a common mechanism of toxicity with other substances
or how to include this pesticide in a cumulative risk assessment.
Therefore a cumulative assessment was not done for this chemical.
E. Safety Determination
1. U.S. population. Using the conservative assumptions described
above, based on the completeness and reliability of the toxicity data,
it is concluded that aggregate exposure, in this case food only, to the
proposed uses of foramsulfuron will utilize <0.001% of the reference
dose for the U.S. population. The actual exposure is likely to be much
less as more realistic data and models are developed. EPA generally has
no concern for exposures below 100% of the RfD because the RfD
represents the level at or below which daily aggregate exposure over a
lifetime will not pose appreciable risk to human health. DWLOC based on
the dietary exposure are much greater than highly conservative
estimated levels, and would be expected to be well below the 100% level
of the RfD, if they occur at all. Therefore, there is a reasonable
certainty that no harm will occur to the U.S. population from aggregate
exposure (food and drinking water) to foramsulfuron.
2. Infants and children. No evidence of increased sensitivity to
fetuses was noted in developmental toxicity studies in rats or rabbits.
There has been no indication of reproductive effects or indication of
increased sensitivity to the offspring in the 2-generation rat
reproduction study. No additional safety factor to protect infants and
children is necessary as there is no evidence of increased sensitivity
in infants and children.
Using the conservative assumptions described in the exposure
section above, the percent of the reference dose that will be used for
exposure to residues of foramsulfuron in food for non-nursing infants
(the most highly exposed sub group) is <0.001%. The children (1-6)
exposure uses are also <0.001% of the reference dose. As in the adult
situation, DWLOC are much higher than the worst case DWEC and are
expected to use well below 100% of the RfD, if they occur at all.
Therefore, there is a reasonable certainty that no harm will occur to
infants and children from aggregate exposure to residues of
F. International Tolerances
There are no Codex Alimentarius Commission (CODEX) maximum residue
levels (MRLs) established for residues of foramsulfuron.
[FR Doc. 01-3093 Filed 2-6-01; 8:45 am]