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iodosulfuron methyl sodium Pesticide Tolerance 9/02

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0141 FRL-7187-2]

Iodosulfuron-Methyl-Sodium; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerances for residues of
iodosulfuron-methyl-sodium, methyl 4-iodo-2-[3-(4-methoxy-6-methyl-
1,3,5 triazin-2-yl)ureidosulfonyl]benzoate, sodium salt, in or on corn,
field, grain; corn, field, forage; and corn, field, stover. Aventis
CropScience USA LP requested this tolerance under the Federal Food,
Drug,and Cosmetic Act, as amended by the Food Quality Protection Act of
1996.

DATES: This regulation is effective September 11, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0141
must be received on or before November 12, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0141 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: (703) 305-6224; e-mail
address: Miller.Joanne@epa.gov.

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,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to theFederal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently
under development. To access the OPPTS Harmonized Guidelines referenced
in this document, go directly to the guidelines at http://www.epa.gov/
opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0141. The official record
consists of the documents specifically referenced in this action, 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 Hwy.,
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.

II. Background and Statutory Findings

    In the Federal Register of January 24, 2001 (66 FR 7644) (FRL-6758-
9), EPA issued a notice pursuant to section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food
Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing
the filing of a pesticide petition (PP F6160) by Aventis CropScience
USA LP, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle Park,
NC 27709. This notice included a summary of the petition prepared by
Aventis CropScience, the registrant. There were no comments received in
response to the notice of filing.
    The petition requested that 40 CFR 180.580 be amended by
establishing tolerances for residues of the herbicide iodosulfuron-
methyl-sodium, methyl 4-iodo-2-[3-(4-methoxy-6-methyl-1,3,5 triazin-2-
yl)ureidosulfonyl]benzoate, sodium salt, in or on corn, field, grain at
0.03 part per million (ppm); corn, field, forage at 0.05 ppm; and corn,
field, stover at 0.05 ppm.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue * * *.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for a tolerance for residues of iodosulfuron-methyl-sodium
on corn, field, grain at 0.03 ppm; corn, field, stover at 0.05 ppm; and
corn, field, forage at 0.05 ppm. EPA's assessment of exposures and
risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by iodosulfuron-
methyl-sodium are discussed in the following Table 1 as well as the no
observed adverse effect level (NOAEL) and the lowest observed adverse
effect level (LOAEL) from the toxicity studies reviewed.

Table 1.--Subchronic, Chronic, and Other Toxicity
Guideline No.
Study type
Results
870.3100 90-Day oral toxicity rodents-rat NOAEL = 67 mg/kg/day in males, 74 mg/kg/day in females.
LOAEL = 347 mg/kg/day in males, 388 mg/kg/day in females based on reduced
body weight and overall body weight gains in both sexes
870.3100 90-Day oral toxicity rodents-mouse NOAEL = 119 mg/kg/day in males, Not observed in females
LOAEL = 332 mg/kg/day in males, 139 mg/kg/day in females based on
hepatotoxicity
870.3150 90-Day oral toxicity nonrodents-dog NOAEL = 8.1 mg/kg/day in males, 8.4 mg/kg/day infemales.
LOAEL = 49 mg/kg/day in males, 51 mg/kg/day in females based on changes in hematology,
microscopic pathology of the bone marrow and spleen (females), clinical
chemistry (males)
870.3700 Prenatal developmental in rodents-rat Maternal: NOAEL = 315 mg/kg/day
LOAEL = 1,000 mg/kg/day based on increased salivation
Developmental: NOAEL = 315 mg/kg/day
LOAEL =1,000 mg/kg/day based on delayed ossification
870.3700 Prenatal developmental in nonrodents-rabbit Maternal: NOAEL = 400 mg/kg/day (HDT)
LOAEL = Not observed
Developmental: NOAEL = 400 mg/kg/day (HDT)
LOAEL = Not observed
870.3800 Reproduction and fertility effects-rat Parental/Systemic NOAEL = 346 mg/kg/day in males, 390 mg/kg/day in females
(HDT).
LOAEL = not established.
Reproductive NOAEL = 346 mg/kg/day in males, 390 mg/kg/day in females (HDT).
LOAEL = not established.
Offspring NOAEL = 34.2 mg/kg/day in males, 39.7 mg/kg/day in females.
LOAEL = 346 mg/kg/day in males, 390 mg/kg/day in females (HDT) based on pup
mortality.
870.4100 Chronic toxicity-dogs NOAEL = 41.8 mg/kg/day in males, 7.25 mg/kg/day in females
LOAEL = Not Established in males, 43.7 mg/kg/day in females based on gross and
histopathologic changes observed in the hematopoietic system.
870.4300 Chronic/carcinogenicity-rats NOAEL = 29.7 mg/kg/day in males, 39.1 mg/kg/day in females.
LOAEL = 331 mg/kg/day in males and 452 mg/kg/day in females based on reduced
body weight and body weight gains in males and on reduced body weight, body
weight gains and food efficiency in females.
No evidence of carcinogenicity.
870.4300 Carcinogenicity-mice NOAEL = 54.2 mg/kg/day in males, 57.6 mg/kg/day in females.
LOAEL = 279 mg/kg/day in males, 277 mg/kg/day in females based on increased
liver weights and histopathological changes in the liver.
No evidence of carcinogenicity at doses tested.
870.5100 Gene mutation Non-mutagenic when tested up to 5000 ug/plate, in presence and absence of metabolic
activation, in S. typhimurium strains TA98, TA100, TA1535 and TA1537 and
E.coli strain WP2uvra.
870.5300 Gene mutation Negative for induction of forward mutation at the HPRT locus in Chinese hamster
V79 lung fibroblasts, in the presence or absence of S9-activation at doses up to
limit of solubility (2649 Fg/mL).
870.5375 Chromosome aberration Did not induce structural chromosome aberration in Chinese hamster lung (V79) cell
cultures in the presence and absence of activation up to cytotoxic concentrations.
870.5385 Chromosomal aberration Non-mutagenic in NMRI mouse bone marrow micronucleus chromosomal aberrations
assay up to the limit dose (2,000 mg/kg).
870.5550 Other genotoxicity No evidence that unscheduled DNA synthesis was induced by iodosulfuron-methyl,
as determined by radioactive tracer procedures nuclear silver grain counts.
Iodosulfuron-methyl was tested up to cytotoxic concentrations ($3,000 µg/mL).
UDS activity was assessed at 0.01 to 1,000 µg/mL.
870.7485 Metabolism and pharmacokinetics-rat Total recovery of the administered dose was 95.9-102.4% for all treatment groups.
No radioactivity was detected in exhaled air or organic volatiles. Elimination of radioactivity occurred primarily in the urine, mostly within 24 hours of dosing, and
was essentially complete within 3 days of dosing. Overall urinary excretion accounted
for 78.5% and 85.8% of the dose for males and females, respectively, and fecal elimination accounted for 19.2% and 10.1% of the dose, respectively. By 3 days post-dose, =0.5% of the dose remained in the blood and tissues of both sexes of rats from the low- and high-dose groups. Rats excreted the majority of the dose as unchanged parent via the urine (48.7- 86.3% dose) or feces (1.1-11.1% dose). Minor routes of metabolism for iodosulfuron-methyl included hydrolysis of the methylester to form 4-iodo-2-[3-(4-
methoxy-6-methyl-1,3,5-triazin-2-yl)ureidosulfonyl] benzoic acid (AE F145740; 0.9-
4.5% dose); O-demethylation of the triazine ring to form methyl 2-[3-(4-hydroxy-6-
methyl-1,3,5-triazin-2-yl)ureidosulfonyl]-4-iodobenzoate (AE F148741; 1.5-8.2%
dose); or hydroxylation of the methyl group on the triazine ring to form methyl 2-
[3-(4-hydroxymethyl-6-methoxy-1,3,5-triazin-2-yl)ureidosulfonyl]-4-iodobenzoate
(AE F168532; 0.3-6.6% dose). Each of these minor metabolites was present in
both the urine and feces. The remaining metabolites each accounted for <3% of
the dose.
870.7485 Metabolism and pharmacokinetics-dog Within 72 hours of oral dosing, 90-94% of the dosed radioactivity was recovered in
the excrement and cage wash of both dose groups. Renal excretion accounted for
64-74% of the dose and elimination in the feces accounted for 14-17% of the radioactive
dose. Most of the dose was excreted within 24 hours. Quantitative RPHPLC
analyses isolated up to 6 distinct radioactive components in urine and
feces. The major isolated fraction was the parent: urine (54-61% dose) and feces
(8-11%).
In the rat, the major isolated fraction was also the parent, while the major metabolite
was AE F145741. The metabolites identified in the dog were consistent with those
identified in the rats.
870.7600 Dermal penetration-rat For both the low- and high-dose groups, dermal penetration of radioactivity was low
(< 2% dose) at exposure intervals up to 8 hours. Absorption increased slightly with
duration of exposure in the low-dose group, increasing from 0.019% of the dose
(0.043 Fg/cm2) at 3 hours to 0.69% of the dose (0.159 Fg/cm2) at 8 hours. However,
a similar trend was not observed in the high-dose group, as the maximum
absorption was observed at the 5-hour exposure (1.60% dose, 6.02 Fg/cm2).
B. Toxicological Endpoints

    The dose at which the NOAEL from the toxicology study identified as
appropriate for use in risk assessment is used to estimate the
toxicological level of concern (LOC). However, the lowest dose at which
adverse effects of concern are identified the LOAEL is sometimes used
for risk assessment if no NOAEL was achieved in the toxicology study
selected. An uncertainty factor (UF) is applied to reflect
uncertainties inherent in the extrapolation from laboratory animal data
to humans and in the variations in sensitivity among members of the
human population as well as other unknowns. An UF of 100 is routinely
used, 10X to account for interspecies differences and 10X for intra
species differences.
    For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 106 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for iodosulfuron-methyl-sodium used
for human risk assessment is shown in the following Table 2:

   
Table 2.--Summary of Toxicological Dose and Endpoints for Iodosulfuron-Methyl-Sodium for Use in Human Risk
Exposure scenario
Dose used in risk assessment,
UF
FQPA SF and level of concern
for risk assessment
Study and toxicological effects
Acute dietary for general population NOAEL= 315 mg/kg/day
UF = 100
aRfD = 3.15 mg/kg/day
FQPA SF = 10x
aPAD = 0.31 mg/kg/day
Developmental Toxicity in Rats
Based on increased salivation seen in dams on day one and throughout the dosing period at the high dose of 1,000 mg/kg/day (LOAEL, Maternal)
Chronic dietary all populations NOAEL = 7.3 mg/kg/day
UF = 100
cRfD = 0.073 mg/kg/day
FQPA SF= 10
cPAD = 0.007 mg/kg/day
Chronic Oral Toxicity diet - dog
Based on gross and histopathologic changes observed in the hematopoietic system seen at 1,200 ppm (LOAEL 43.7 mg/kg/day)
Incidental oral short-term (1-30
days)
Oral NOAEL = 49 mg/kg/day FQPA SF= 10
LOC for MOE = 1,000
(residential)
Subchronic Oral Toxicity diet - dog
Based on alterations in hematological parameters and changes in clinical chemistry seen at 4 week observation period at a dose level of 301 mg/kg/day (HDT)
Incidental oral, intermediate term
(30 days-6 months)
Oral NOAEL= 8.1 mg/kg/day FQPA SF= 10
LOC for MOE = 1,000
(residential)
Subchronic Oral Toxicity diet - dog
Based on changes in hematology (males and
females), microscopic pathology of the bone
marrow (males and females) and spleen (females), and clinical chemistry (males) seen at termination at a dose level of 49 mg/kg/day (LOAEL)
Dermal short-term (1-30 days) Oral NOAEL= 49 mg/kg/day
dermal absorption factor 2%
LOC for MOE = 1,000
(residential)
LOC for MOE = 100
(occupational)
Subchronic Oral Toxicity diet - dog.
Based on alterations in hematological parameters
and changes in clinical chemistry seen
at 4 week observation period at a dose level
of 301 mg/kg/day (HDT)
Dermal, intermediate-term (30
days-6 months)
Oral NOAEL= 8.1 mg/kg/day
dermal absorption factor 2%
LOC for MOE = 1,000
(residential)
LOC for MOE = 100
(occupational)
Subchronic Oral Toxicity diet - dog
Based on changes in hematology (males and
females), microscopic pathology of the bone
marrow (males and females) and spleen (females),
and clinical chemistry (males) seen at termination at a dose level of 49 mg/kg/ day (LOAEL)
Dermal, long-term (6 months-life time) Oral NOAEL= 7.3 mg/kg/day
dermal absorption factor 2%
LOC for MOE = 1,000
(residential)
LOC for MOE = 100
(occupational)
Chronic Oral Toxicity diet - dog
Based on gross and histopathologic changes
observed in the hematopoietic system seen
at 1,200 ppm (LOAEL 43.7 mg/kg/day)
Inhalation, short-term (1-30 days) Oral NOAEL= 49 mg/kg/day
inhalation absorption factor 100%
LOC for MOE = 1,000
(residential)
LOC for MOE = 100
(occupational)
Subchronic Oral Toxicity diet - dog
Based on alterations in hematological parameters
and changes in clinical chemistry seen
at 4 week observation period at a dose level
of 301 mg/kg/day (HDT)
Inhalation, intermediate-term (30
days-6 months)
Oral NOAEL= 8.1 mg/kg/day
inhalation absorption factor 100%
LOC for MOE = 1,000
(residential)
LOC for MOE = 100
(occupational)
Subchronic Oral Toxicity diet - dog
Based on changes in hematology (males and
females), microscopic pathology of the bone
marrow (males and females) and spleen (females),
and clinical chemistry (males) seen
at termination at a dose level of 49 mg/kg/
day (LOAEL)
Inhalation, Long-term (6 monthslife
time)
Oral NOAEL= 7.3 mg/kg/day
inhalation absorption factor 100%
LOC for MOE = 1,000
(residential)
LOC for MOE = 100
(occupational)
Chronic Oral Toxicity diet - dog
Based on gross and histopathologic changes
ST observed in the hematopoietic system
seen at 1,200 ppm (LOAEL 43.7 mg/kg/day)
The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. This is the first
request for an iodosulfuron-methyl-sodium registration to establish
tolerances for the residues of iodosulfuron-methyl-sodium, in or on a
variety of raw agricultural commodities. Metsulfuron-methyl (registered
active ingredient; PC code 122010) has been identified as a residue of
concern in drinking water as a result of iodosulfuron-methyl-sodium
application (metsulfuron-methyl was not identified as a residue of
concern in cereal grains or livestock). Since metsulfuron-methyl had
not undergone a full review by the EPA at the time the iodosulfuron-
methyl-sodium risk assessment was completed, it was assumed that the
doses and endpoints identified for iodosulfuron-methyl-sodium were
applicable to metsulfuron-methyl. This assumption was considered
appropriate based on structural activity relationship (both are
sulfonylureas), and the fact that metsulfuron-methyl is a predominant
metabolite of iodosulfuron-methyl-sodium in soil in drinking water.
Recently, metsulfuron-methyl has undergone a full review by EPA. In all
instances, excluding short-term inhalation and incidental oral, the
metsulfuron-methyl endpoints were greater than those identified for
iodosulfuron-methyl-sodium. No acute dietary endpoint was selected for
metsulfuron-methyl. Since metsulfuron-methyl was considered
toxicologically equivalent to iodosulfuron-methyl-sodium for risk
assessment purposes, the dietary and residential analyses included all
registered and proposed uses for iodosulfuron-methyl-sodium and
metsulfuron-methyl. Additionally, the iodosulfuron-methyl-sodium risk
assessment incorporated a 10X FQPA safety factor (metsulfuron-methyl
has a 1X FQPA safety factor). Therefore, this assessment is considered
highly conservative. The nature of metsulfuron-methyl residues in/on
cereal grains (residues of concern - metsulfuron-methyl and its 4
hydroxy metabolite) and ruminants (residues of concern - metsulfuron-
methyl) have been determined and tolerances have been established in/on
barley, grass, sugarcane, wheat, sorghum, milk and in the fat, meat,
meat byproducts, and kidney of cattle, goats, hogs, horses, and sheep
ranging from 0.05 - 20 ppm (40 CFR 180.428). Based on data from the
ruminant and poultry metabolism studies, in which a cow and hens were
dosed at 179x and 333x the MTDB, respectively, there is no reasonable
expectation that finite residues of iodosulfuron-methyl-sodium will
occur in livestock commodities (40 CFR 180.6(a)(3)). Therefore,
livestock feeding studies and tolerances for livestock commodities were
not performed. If the use of iodosulfuron-methyl-sodium is expanded in
the future to include other livestock feed items, the need for feeding
studies will be reevaluated. Risk assessments were conducted by EPA to
assess dietary exposures from iodosulfuron-methyl-sodium in food as
follows:
    i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1 day or
single exposure. The Dietary Exposure Evaluation Model
(DEEMTM) analysis evaluated the individual food consumption
as reported by respondents in the USDA 1989-1992 nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure
to the chemical for each commodity. The following assumptions were made
for the acute exposure assessments: The acute analysis was performed
for the general U.S. population and all population subgroups using
existing and recommended tolerance level residues, 100% crop treated
information, and DEEMTM default processing factors for all
iodosulfuron-methyl-sodium and metsulfuron-methyl registered and
proposed commodities.
    ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEMTM analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992 nationwide
CSFII and accumulated exposure to the chemical for each commodity. The
following assumptions were made for the chronic exposure assessments:
The chronic analysis was performed for the general U.S. population and
all population subgroups using existing and recommended tolerance level
residues, 100% crop treated information, and DEEMTM default
processing factors for all iodosulfuron-methyl-sodium and metsulfuron-
methyl registered and proposed commodities.
    iii. Cancer. The mouse carcinogenicity study was negative as was
the carcinogenicity study conducted in rats. Iodosulfuron-methyl-sodium
was negative for mutagenicity in various assays. Furthermore,
registered sulfonyl urea compounds (structurally similar compounds)
have been found to be non-carcinogenic. The maximum dose, however, was
not achieved for the mouse cancer study for iodosulfuron-methyl-sodium;
thus, EPA has requested a new carcinogenicity study in mice as
confirmatory data.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for iodosulfuron-methyl-sodium
and metsulfuron-methyl in drinking water. Because the Agency does not
have comprehensive monitoring data, drinking water concentration
estimates are made by reliance on simulation or modeling taking into
account data on the physical characteristics of iodosulfuron-methyl-
sodium and metsulfuron-methyl.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS),
to produce estimates of pesticide concentrations in an index reservoir.
The Screening Concentrations in Ground Water (SCI-GROW) model is used
to predict pesticide concentrations in shallow ground water. For a
screening-level assessment for surface water EPA will use FIRST (a tier
1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a
subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an
index reservoir environment, the PRZM/EXAMS model includes a percent
crop area factor as an adjustment to account for the maximum percent
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from
residential uses. Since DWLOCs address total aggregate exposure to
iodosulfuron-methyl-sodium and metsulfuron-methyl, they are further
discussed in the aggregate risk sections see section E.
    Based on the PRZM/EXAMS and SCI-GROW models, the EECs of
iodosulfuron-methyl-sodium and metsulfuron-methyl for acute exposures
are estimated to be 1.43 parts per billion (ppb) for surface water and
0.105 ppb for ground water. The EECs for chronic exposures are
estimated to be 0.338 ppb for surface water and 0.105 ppb for ground
water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Iodosulfuron-methyl-sodium is not registered for use on any sites
that would result in residential exposure. However, metsulfuron-methyl
is currently registered for use on the following residential non-
dietary site(s): Golf courses and residential turfgrass. Based on the
use pattern, potential residential exposure scenarios include:
    [sbull]
Golfer post-application exposure (adult and adolescent)
    [sbull]
Non-dietary ingestion (toddler hand-to-mouth, object-to-
mouth, soil ingestion)
    [sbull]
Dermal post-application exposure to turfgrass (adult and
toddler)
    All MOEs calculated for residential post-application exposures do
not exceed the HED's levels of concern for the respective exposure
scenarios (MOEs<1,000).
    4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine
whether iodosulfuron-methyl-sodium and metsulfuron-methyl have a common
mechanism of toxicity with other substances or how to include these
pesticides in a cumulative risk assessment. Unlike other pesticides for
which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, iodosulfuron-methyl-sodium and metsulfuron-
methyl do not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has not assumed that iodosulfuron-methyl-sodium and metsulfuron-methyl
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see the final rule for Bifenthrin Pesticide Tolerances
(62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. There is evidence for both
quantitative and qualitative increased susceptibility in the multi-
generation rat reproduction study. While no parental toxicity was seen
at the HDT (346 mg/kg/day), off-spring toxicity was manifested as
reduced pup viability (death on Day 0 in F2, LOAEL 346 mg/
kg/day; NOAEL 34 mg/kg/day). Similarly, there is evidence for
qualitative increase in susceptibility in the rat developmental
toxicity study where delayed ossification was observed in the fetuses
of dams that exhibited minimal maternal toxicity (salivation; maternal
and developmental LOAEL 1,000 mg/kg/day and NOAEL 315 mg/kg/day).
Maternal and developmental LOAELs were not established in the non-
rodent (rabbit) developmental toxicity study (HDT 400 mg/kg/day; study
is classified as unacceptable/not upgradable due to inadequate dosing).
Therefore, susceptibility of the offspring could not be addressed in
this species.
    3. Conclusion. There is a complete toxicity data base for
iodosulfuron-methyl-sodium. EPA concluded that the FQPA safety factor
be retained at 10x for iodosulfuron-methyl-sodium for the following
weight-of-evidence considerations: There is qualitative evidence of
increased susceptibility following in utero exposure to iodosulfuron-
methyl-sodium in the rat developmental toxicity study; there is
quantitative and qualitative evidence of increased susceptibility
following prenatal/postnatal exposure to iodosulfuron-methyl-sodium in
the 2-generation reproduction study in rats; susceptibility could not
be assessed in the non-rodent (rabbit) developmental study since the
doses tested in this study were considered to be inadequate (this study
is classified as unacceptable); there is a data gap for an acute
neurotoxicity study conducted in adult rats required to confirm and
characterize the signs of neurotoxicity observed in the 90-day dog
study and the rat developmental toxicity study; and the requirement for
a developmental neurotoxicity study (DNT) with iodosulfuron-methyl-
sodium is ``reserved'' pending the results of the acute neurotoxicity
study.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water [e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the Office of Water are used to calculate DWLOCs: 2L/
70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child).
Default body weights and drinking water consumption values vary on an
individual basis. This variation will be taken into account in more
refined screening-level and quantitative drinking water exposure
assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when
considered along with other sources of exposure for which OPP has
reliable data) would not result in unacceptable levels of aggregate
human health risk at this time. Because OPP considers the aggregate
risk resulting from multiple exposure pathways associated with a
pesticide's uses, levels of comparison in drinking water may vary as
those uses change. If new uses are added in the future, OPP will
reassess the potential impacts of residues of the pesticide in drinking
water as a part of the aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
iodosulfuron-methyl-sodium and metsulfuron-methyl will occupy 1% of the
aPAD for the U.S. population, <1% of the aPAD for females 13 years and
older, 1% of the aPAD for all infants and 1% of the aPAD for children
(1-6 years old). In addition, there is potential for acute dietary
exposure to iodosulfuron-methyl-sodium and metsulfuron-methyl in
drinking water. After calculating DWLOCs and comparing them to the EECs
for surface and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the aPAD, as shown in the following Table 3:

   
Table 3.--Aggregate Risk Assessment for Acute Exposure to Iodosulfuron-Methyl-Sodium and Metsulfuron-Methyl
Population Subgroup
aPAD (mg/kg)
% aPAD
(Food)
Surface Water EEC
(ppb)
Ground Water EEC
(ppb)
Acute
DWLOC
(ppb)
U.S. population—all seasons 0.315 1 1.42 0.105 11,000
All Infants (<1 year old) 0.315 1 1.42 0.105 3,100
Children (1-6 years old) 0.315 1 1.42 0.105 3,100
Children (7-12 years old) 0.315 1 1.42 0.105 3,100
Females (13-50 years old) 0.315 <1 1.42 0.105 9,400
Males (13-19 years old) 0.315 1 1.42 0.105 11,000
Males (20+ years old) 0.315 <1 1.42 0.105 11,000
Seniors (55+ years old) 0.315 <1 1.42 0.105 11,000

    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
iodosulfuron-methyl-sodium and metsulfuron-methyl from food will
utilize 10% of the cPAD for the U.S. population, 12% of the cPAD for
all infants and 29% of the cPAD for children (1-6 years old). There are
no residential uses for iodosulfuron-methyl-sodium and metsulfuron-
methyl that result in chronic residential exposure. Based on the use
pattern, chronic residential exposure to residues of iodosulfuron-
methyl-sodium and metsulfuron are not expected. In addition, there is
potential for chronic dietary exposure to iodosulfuron-methyl-sodium
and metsulfuron-methyl in drinking water. After calculating DWLOCs and
comparing them to the EECs for surface and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the cPAD, as shown in
the following Table 4:

     
Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Iodosulfuron-Methyl-Sodium and Metsulfuron-Methyl
Population Subgroup
cPAD mg/kg/day
% cPAD
(Food)
Surface Water EEC
(ppb)
Ground Water EEC
(ppb)
Chronic
DWLOC
(ppb)
U.S. population 0.0073 10 0.338 0.105 230
All Infants (<1 year old) 0.0073 12 0.338 0.105 65
Children (1-6 years old) 0.0073 29 0.338 0.105 52
Children (7-12 years old) 0.0073 17 0.338 0.105 61
Females (13-50 years old) 0.0073 7 0.338 0.105 200
Males (13-19 years old) 0.0073 11 0.338 0.105 240
Males (20+ years old) 0.0073 7 0.338 0.105 240
Seniors (55+ years old) 0.0073 6 0.338 0.105 240

    3. Short-term risk. Iodosulfuron-methyl-sodium is not registered
for use on any sites that would result in residential exposure.
However, for the purposes of this assessment, iodosulfuron-methyl-
sodium and metsulfuron-methyl are being considered toxicologically
equivalent. Metsulfuron-methyl is currently
registered for use that could result in short-term residential
exposure. Since a common toxicological effect was identified when
assessing short-term oral and dermal exposures (alterations in
hematology and clinical chemistry parameters), the aggregate short-term
assessment considered exposure from food (chronic dietary), water, and
residential uses (oral and dermal). The short-term oral and dermal
endpoints were based on the same study, and therefore can be
aggregated.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 5.6e+05 for all U.S.
populations, 2.5e+05 for all infants (<1 year old), 1.5e+05 for
children (1-6 years old), 2.1e+05 for children (7-12 years old),
7.7e+05 for females (13-50 years old), 5.1e+05 for males (13-19 years
old), 7.4e+05 for males (20+ years old), and 8.4e+05 for seniors (55+
years old). These aggregate MOEs do not exceed the Agency's level of
concern. In addition, short-term DWLOCs were calculated and compared to
the EECs for average exposure of iodosulfuron-methyl-sodium and
metsulfuron-methyl in ground and surface water. DWLOCs were then
calculated using the following default body weights and drinking water
consumption figures: 70 kg/2L (adult male), 60 kg/2L (adult female) and
10 kg/1L (infant/child). After calculating DWLOCs and comparing them to
the EECs for surface and ground water, EPA does not expect short-term
aggregate exposure to exceed the Agency's level of concern, as shown in
the following Table 5:

Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Iodosulfuron-Methyl-Sodium and Metsulfuron-Methyl
Population Subgroup
Aggregate
MOE (Food
+ residential)
Aggregate
level of concern
(LOC)
Surface Water EEC
(ppb)
Ground Water EEC
(ppb)
Short-term
DWLOC
(ppb)
U.S. population—all 5.6e+05 1,000 0.338 0.105 1.7e+03
All Infants (<1 year old) 2.5e+05 1,000 0.338 0.105 4.7e+02
Children (1-6 years old) 1.5e+05 1,000 0.338 0.105 4.6e+02
Children (7-12 years old) 2.1e+05 1,000 0.338 0.105 4.7e+02
Females (13-50 years old) 7.7e+05 1,000 0.338 0.105 1.5e+03
Males (13-19 years old) 5.1e+05 1,000 0.338 0.105 1.7e+03
Males (20+ years old) 7.4e+05 1,000 0.338 0.105 1.7e+03
Seniors (55+ years old) 8.4e+05 1,000 0.338 0.105 1.7e+03
    4. Intermediate-term risk. Iodosulfuron-methyl-sodium is not
registered for use on any sites that would result in residential
exposure. However, for the purposes of this assessment, iodosulfuron-
methyl-sodium and metsulfuron-methyl are being considered
toxicologically equivalent. Metsulfuron-methyl is currently registered
for use that could result in intermediate-term residential exposure.
Therefore, the aggregate intermediate-term assessment considered
exposure from food (chronic dietary), water, and residential uses.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 1.1e+04
for all U.S. populations, 9.6e+03 and all infants (<1 year old),
3.9e+03 for children (1-6 years old), 6.6e+03 for children (7-12 years
old), 1.7e+04 for females (13-50 years old), 1.0e+04 for males (13-19
years old), 1.7e+04 for males (20+ years old), and 2.0e+04 for seniors
(55+ years old). These aggregate MOEs do not exceed the Agency's level
of concern for food and residential uses. In addition, intermediate-
term DWLOCs were calculated and compared to the EECs for chronic
exposure of iodosulfuron-methyl-sodium and metsulfuron-methyl in ground
and surface water. DWLOCs were then calculated using the following
default body weights and drinking water consumption figures: 70kg/2L
(adult male), 60kg/2L (adult female) and 10kg/1L (infant/child). After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect intermediate-term aggregate exposure
to exceed the Agency's level of concern, as shown in the following
Table 6:

 
Table 6.--Aggregate Aggregate Risk Assessment for Intermediate-Term Exposure to Iodosulfuron-Methyl-Sodium and Metsulfuron- Methyl
Population Subgroup
Aggregate
MOE (Food
+ residential)
Aggregate
level of concern
(LOC)
Surface Water EEC
(ppb)
Ground Water EEC
(ppb)
Intermediate term
DWLOC
(ppb)
U.S. population—all 1.1e+04 1,000 0.338 0.105 2.6e+02
All Infants (<1 year old) 9.6e+03 1,000 0.338 0.105 7.3e+01
Children (1-6 years old) 3.9e+03 1,000 0.338 0.105 6.0e+01
Children (7-12 years old) 6.6e+03 1,000 0.338 0.105 6.9e+01
Females (13-50 years old) 1.7e+04 1,000 0.338 0.105 2.3e+02
Males (13-19 years old) 1.0e+04 1,000 0.338 0.105 2.6e+02
Males (20+ years old) 1.7e+04 1,000 0.338 0.105 2.7e+02
Seniors (55+ years old) 2.0e+04 1,000 0.338 0.105 2.7e+02
    5. Aggregate cancer risk for U.S. population. Given the available
data, it is likely that iodosulfuron-methyl-sodium does not pose a
cancer risk to humans. To date, cancer studies have proven negative and
metsulfuron-methyl is classified as Group E (not likely human
carcinogen) by Agency. Other registered sulfonyl urea compounds have
also been found to be non-carcinogenic. There is some uncertainty here,
however, due to the failure to test at a high enough dose in the mouse
study. Nonetheless, given the following considerations, even assuming
that the requested cancer study showed that iodosulfuron-methyl-sodium
has some carcinogenic potential, EPA concludes that the cancer risk
from exposure to iodosulfuron-methyl-sodium is negligible. First,
cancer testing at relatively high doses has already had negative
results, so the new study, at worst, could show iodosulfuron-methyl-
sodium to be a relatively weak carcinogen. Second, human exposure to
iodosulfuron-methyl-sodium is expected to be basically non-existent.
Field corn will be the only registered use, and field corn is only
consumed by animals not humans. Studies have shown that there is no
reasonable expectation that finite residues of iodosulfuron-methyl-
sodium will occur in livestock commodities as a result of livestock
consuming iodosulfuron-methyl-sodium -treated corn. Finally, there are
no residential uses for iodosulfuron-methyl-sodium.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to iodosulfuron-methyl-sodium and metsulfuron-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The analytical methods used to analyze the storage stability, field
trial, and processing samples were adequately validated and are
appropriate for data gathering purposes. The proposed tolerance
enforcement method has been adequately validated by an independent
laboratory and was forwarded to the Analytical Chemistry Laboratory
(ACL) for petition method validation (PMV). The ACL concludes that this
method using HPLC/MS, in general, meets the requirements for a residue
analytical method for tolerance enforcement as defined in the Residue
Chemistry Test Guidelines, 860.1340. The petitioner submitted data
which indicated that iodosulfuron-methyl-sodium and metsulfuron-methyl
are not adequately recovered when using FDA multiresidue method
protocols. This information has been forwarded to the FDA.

B. International Residue Limits

    There is neither a Codex proposal, nor Canadian or Mexican limits,
for residues of iodosulfuron-methyl-sodium in/on field corn.
Harmonization is not an issue for this petition.

C. Conditions

    EPA is able to successfully validate the proposed field corn
enforcement method and concludes that the toxicological, residue
chemistry, and occupational/residential databases are sufficient for a
conditional field corn registration. The following data are being
required to confirm the results of the studies already reviewed by the
Agency and/or to complete the database requirements prior to approval
of an unconditional registration of iodosulfuron-methyl-sodium:
    i. Acute Neurotoxicity Study--to confirm the clinical signs of
neurotoxicity.
    ii. 28-Day Inhalation Toxicity Study - for further characterization
of inhalation hazard for risk assessment; the protocol for the existing
90-day inhalation toxicity study (OPPTS 870.3465) should be followed
with the exposure (treatment) ending after 28 days, instead of 90 days.
    iii. 21-Day Dermal Toxicity Study
    iv. Developmental Toxicity Study in Rabbits
    v. Carcinogenicity Study in Mice

V. Conclusion

    Therefore, the tolerance is established for residues of
iodosulfuron-methyl-sodium, methyl 4-iodo-2-[3-(4-methoxy-6-methyl-
1,3,5 triazin-2-yl)ureidosulfonyl]benzoate, sodium salt, in or on corn,
field, grain at 0.03 ppm; corn, field, forage at 0.05 ppm; and corn,
field, stover at 0.05 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.

[[Page 57531]]

However, the period for filing objections is now 60 days, rather than
30 days.

A. What Do I Need To Do To File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-2002-0141 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before November
12, 2002.
    1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential 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. A copy of the
information 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.
    Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. 104, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket ID number OPP-2002-0141 to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). \1\This rule,
however, has been repealed. This action does not involve any technical
standards that would require Agency consideration of voluntary
consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law
104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and
exemptions that are established on the basis of a petition under FFDCA
section 408(d), such as the tolerance in this final rule, do not
require the issuance of a proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
In addition, the Agency has determined that this action will not have a
substantial direct effect on States, on the relationship between the
national government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism(64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of FFDCA section 408(n)(4).
For these same reasons, the Agency has determined that this rule does
not have any ``tribal implications'' as described in Executive Order
13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: September 3, 2002.
James Jones,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 374.

    2. Section 180.580 is added to read as follows:

Sec.  180.580  Iodosulfuron-Methyl-Sodium; tolerances for residues.

    (a) General. Tolerances are established for residues of the
herbicide Iodosulfuron-Methyl-Sodium (methyl 4-iodo-2-[3-(4-methoxy-6-
methyl-1,3,5 triazin-2-yl)ureidosulfonyl]benzoate, sodium salt) in or
on the following commodities:

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Corn, field, forage.......................  0.05
Corn, field, grain........................  0.03
Corn, field, stover.......................  0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 02-23086 Filed 9-10-02; 8:45 am]
BILLING CODE 6560-50-S