[Federal Register Volume 66, Number 26 (Wednesday, February 7, 2001)]
[Notices]
[Pages 9319-9323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3093]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-995; FRL-6765-6]


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

DATES: Comments, identified by docket control number PF-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 
response.

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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.

[[Page 9320]]

    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 protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-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 
CONTACT.

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

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

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data support granting of the petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

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

    Dated: January 25, 2001.
  James Jones,
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.

Aventis CropScience

0F6161

    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.

[[Page 9321]]

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 
inhalation toxicity.
    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 g/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 
in rats.
    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

[[Page 9322]]

for maternal toxicity was 50 mg/kg and 500 mg/kg for developmental 
toxicity (teratogenicity). Foramsulfuron was not teratogenic in the 
rabbit.
    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 
limit dose.
    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 
limit dose).
    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 
g equivalents/g). The residues in the muscle, fat, and skin 
were all found to be 0.003 g 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 g 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 
(DEEMtm) 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.

[[Page 9323]]

    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 
foramsulfuron.

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]
BILLING CODE 6560-50-S