Halosulfuron-methyl; Pesticide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: December 26, 2001 (Volume 66, Number 247)]
[Rules and Regulations]
[Page 66333-66340]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26de01-13]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301200; FRL-6816-8]
RIN 2070-AB78

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

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SUMMARY: This regulation establishes a tolerance for residues of
halosulfuron-methyl in or on the melon subgroup. IR-4 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 December 26, 2001. Objections and
requests for hearings, identified by docket control number OPP-301200,
must be received by EPA on or before February 25, 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 control number OPP-301200 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: (703) 308-3194; and e-mail
address: brothers.shaja@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 Potentially
Categories NAICS 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 the Federal Register listings
at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301200. 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 August 31, 2001 (66 FR 45993) (FRL-6796-
1), 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) for tolerance by the
Interregional Research Project Number 4 (IR-4), 681 U.S. Highway 1
South, North Brunswick, NJ 08902-3390. This notice included a summary
of the petition prepared by Gowan Company, the registrant. There were
no comments received in response to the notice of filing.
The petition requested that 40 CFR 180.479 be amended by
establishing a tolerance for residues of the herbicide halosulfuron-
methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl) aminocarbonylamino]
sulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, in or on the
melon subgroup-crop group 9A (includes citron melon, muskmelon, and
watermelon) at 0.1 part per million (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

[[Page 66334]]

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 halosulfuron-methyl on the
melon subgroup at 0.1 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 halosulfuron-methyl
are discussed in Unit II.A. of the final rule on halosulfuron-methyl
pesticide tolerances published in the Federal Register for September
29, 2000 (65 FR 58424) (FRL-6746-2).

B. Toxicological Endpoints

The dose at which no adverse effects are observed (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 10\-6\ 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 (MOE_cancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for halosulfuron-methyl used for human risk assessment is
shown in the following Table 1:

Table 1.--Summary of Toxicological Dose and Endpoints for halosulfuron-methyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF\*\ and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary females 13-50 years of NOAEL = 50 mg/kg/day; FQPA SF = 1X; aPAD = Developmental- Rabbit;
age UF = 100; Acute RfD = acute RfD/FQPA SF = LOAEL = 150 mg/kg/day
0.5 mg/kg/day 0.5 mg/kg/day based on decreased
mean litter size and
increases in
resorptions and post
implantation loss.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations NOAEL= 10 mg/kg/day; UF FQPA SF = 1X; cPAD = Chronic Toxicity-Dog;
= 100; Chronic RfD = chronic RfD/FQPA SF = LOAEL 40 mg/kg/day
0.1 mg/kg/day 0.1 mg/kg/day decrease in body
weight gain and
alterations in
hematology and
clinical chemistry
parameters.
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 7 days) dermal (or oral) study LOC for MOE = 100 Developmental- Rabbit;
(Residential) NOAEL= 50 mg/kg/day (Residential) LOAEL = 150 mg/kg/day
(dermal absorption based on decreased
rate = 75%) mean litter size and
increases in
resorptions and post
implantation loss.
----------------------------------------------------------------------------------------------------------------

[[Page 66335]]

Intermediate-Term Dermal (1 week to dermal (or oral) study LOC for MOE = 100 Chronic Toxicity-Dog;
several months) to Long - Term NOAEL = 10 mg/kg/day (Residential) LOAEL 40 mg/kg/day
(several months to lifetime) (dermal absorption decrease in body
(Residential) rate = 75% weight gain and
alterations in
hematology and
clinical chemistry
parameters.
----------------------------------------------------------------------------------------------------------------
\*\ 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. Tolerances have been
established (40 CFR 180.479) for residues of halosulfuron-methyl, in or
on the following raw agricultural commodities: squash/cucumber (crop
subgroup 9-B); tree nuts (crop group14), pistachio nutmeat; almond
hulls; sugar cane; corn (sweet, kernel+cob with husks removed; field
grain, fodder and forage; and pop grain and fodder); rice (grain and
straw); and cotton (gin by-products and undelinted seed) at the range
of 0.05 to 0.8 ppm. Additionally, tolerances for residues of
halosulfuron-methyl and its metabolites determined as 3-chloro-1-
methyl-5-sulfamoylpyrazole-4-carboxylic acid (CSA, expressed as parent
equivalents) are established at 0.1 ppm on meat by-products including
cattle, goats, hogs, horses and sheep. Risk assessments were conducted
by EPA to assess dietary exposures from halosulfuron-methyl 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 one day
or single exposure. The Dietary Exposure Evaluation Model
(DEEM) 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 DEEM analysis
was performed assuming tolerance level residues and 100% crop treated
(CT) for commodities for which halosulfuron-methyl is registered and
0.1 ppm (the recommended tolerance) and 100% CT for the melon subgroup
(crop group 9-A). No reduction factors of any kind were used in the
analysis. This analysis is considered highly conservative.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM)
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
DEEM analysis was performed assuming tolerance level residues
and 100% crop treated (CT) for commodities for which halosulfuron-
methyl is registered and a proposed tolerance 0.1 ppm and 100% CT for
the melon subgroup (crop group 9-A). No reduction factors of any kind
were used in the analysis. This analysis is considered highly
conservative.
iii. Cancer. Halosulfuron-methyl is classified as a ``not likely''
human carcinogen based on a lack of evidence of carcinogenicity in male
and female mice and rats. Accordingly, a cancer risk assessment was not
conducted.
2. Dietary exposure from drinking water. The available data on
halosulfuron-methyl (parent) shows that the compound is mobile in soil
and is persistent at phytotoxically significant levels for months to
years at some sites. Halosulfuron-methyl has the potential to leach to
groundwater, and also presents concerns for transport to surface water
by runoff.
The Agency lacks sufficient monitoring exposure data to complete a
comprehensive dietary exposure analysis and risk assessment for
halosulfuron-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 halosulfuron-methyl.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in groundwater. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. 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 halosulfuron-methyl they are
further discussed in the aggregate risk sections below.
Based on the GENEEC model the acute and chronic estimated
environmental concentrations (EECs) of halosulfuron-methyl for surface
water are estimated to be 8.3 µg/L and 1.7 µg/L,
respectively. Based on the SCI-GROW model the estimated EECs of

[[Page 66336]]

halosulfuron-methyl for groundwater is estimated to be 0.065
µg/L.
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).
Halosulfuron-methyl is currently registered for use on the
following residential non-dietary sites: commercial and residential
turf and on other non-crop sites including airports, cemeteries, fallow
areas, golf courses, landscaped areas, public recreation areas,
residential property, road sides, school grounds, sod or turf seed
farms, sports fields, landscaped areas with established woody
ornamentals and other similar use sites. The risk assessment was
conducted as follows: For short-term exposure and risk for residential
lawn applicators (handlers), the resulting dermal exposure for female
handlers is 0.000043 mg/kg/day resulting in an MOE of 1,200,000. This
MOE does not exceed EPA's level of concern for residential handlers.
Chronic- and intermediate-term handler assessments were not conducted
because lawn application of halosulfuron-methyl is not expected to be
made continuously over the duration of the chronic- or intermediate-
term exposure scenarios.
For residential postapplication exposure and risk calculations for
adults, short- and intermediate-term exposures result in MOEs that
range from 1,800 to 5,200. These MOEs do not exceed EPA's level of
concern for adults.
For children's residential postapplication exposure and risk
calculations, dermal exposure was combined with incidental oral hand-
to-mouth and object-to-mouth exposures (because all exposures are
compared to the same endpoint) to represent a worst-case scenario. The
short-term risk estimate results in an MOE of 2,900 and the
intermediate-term risk results in an MOE of 1,100. These risks do not
exceed EPA's level of concern.
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 halosulfuron-methyl has a common mechanism of toxicity with
other substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
halosulfuron-methyl does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that halosulfuron-methyl has 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 database 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 was no indication of
increased susceptibility of rats or rabbits to in utero and/or
postnatal exposure to halosulfuron-methyl. In the prenatal
developmental toxicity studies in rats and rabbits and the two-
generation reproduction study in rats, effects in the offspring were
observed only at or above treatment levels which resulted in evidence
of parental toxicity.
3. Conclusion. There is a complete toxicity database for
halosulfuron-methyl and exposure data are complete or are estimated
based on data that reasonably accounts for potential exposures. EPA
determined that the 10X safety factor to protect infants and children
should be removed. The FQPA factor is removed because there was no
indication of increased susceptibility of rats or rabbits in utero and/
or postnatal exposure to halosulfuran methyl, and although a
developmental neurotoxicity study was required, an additional safety
factor was not warranted.

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 USEPA 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 groundwater 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
halosulfuron-methyl will occupy <1% of the aPAD for females (13 years
and older), infants, and children (1-6 years old). In

[[Page 66337]]

addition, there is potential for acute dietary exposure to
halosulfuron-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 2:

Table 2.-- Aggregate Risk Assessment for Acute Exposure to halosulfuron-methyl
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
All infants 0.5 0.00070 8.3 0.065 5,000
----------------------------------------------------------------------------------------------------------------
Children (1-6 years) 0.5 0.00097 8.3 0.065 5,000
----------------------------------------------------------------------------------------------------------------
Females (13-50 years 0.5 0.00058 8.3 0.065 15,000
----------------------------------------------------------------------------------------------------------------

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
halosulfuron-methyl from food will utilize <1% of the cPAD for the U.S.
population, infants (<1 year old), children (1-6 years old), and
females (13-50 years old). Based on the use pattern, chronic
residential exposure to residues of halosulfuron-methyl is not
expected. In addition, there is potential for chronic dietary exposure
to halosulfuron-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 3:

Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to halosulfuron-methyl
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.10 0.00020 1.7 0.065 3,500
----------------------------------------------------------------------------------------------------------------
All infants (<1 year) 0.10 0.00059 1.7 0.065 1,000
----------------------------------------------------------------------------------------------------------------
Children (1-6 years) 0.10 0.00035 1.7 0.065 1,000
----------------------------------------------------------------------------------------------------------------
Females (13-50 years) 0.10 0.00016 1.7 0.065 3,000
----------------------------------------------------------------------------------------------------------------

3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Halosulfuron-methyl is currently registered for use that could
result in short-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and short-
term exposures for halosulfuron-methyl.
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 4,500 for females 13-50 years
and older, and 2,800 for infants (<1 year old). A short-term risk
assessment is required for adults because there is a residential
exposure scenario (handler and postapplication). In addition, a short-
term risk assessment is required for infants and children because there
are residential post-application dermal and oral exposure scenarios.
The risk calculations for adult females is expected to result in a
higher risk than adult males because a lower body weight is used (60
kg), therefore adult females will represent the U.S. population. These
aggregate MOEs do not exceed the Agency's level of concern for
aggregate exposure to food and residential uses. In addition, short-
term DWLOCs were calculated and compared to the EECs for chronic
exposure of halosulfuron-methyl in ground and surface water. 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
4:

Table 4.--Aggregate Risk Assessment for Short-Term Exposure to halosulfuron-methyl
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 4,500 100 1.7 0.065 17,000
----------------------------------------------------------------------------------------------------------------
Infants (<1 year old) 2,800 100 1.7 0.065 4,800
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 4,500 100 1.7 0.065 15,000
----------------------------------------------------------------------------------------------------------------

[[Page 66338]]

4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Halosulfuron-methyl is currently registered for use(s) that could
result in intermediate-term residential exposure and the Agency has
determined that it is appropriate to aggregate chronic food and water
and intermediate-term exposures for halosulfuron-methyl.
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 1,700
females 13-50 years old, and 1,100 for infants (<1 year old). An
intermediate-term risk assessment is required for adults because there
is a residential exposure scenario (handler and postapplication). In
addition, an intermediate-term risk assessment is required for infants
and children because there are residential post-application dermal and
oral exposure scenarios. The risk calculations for adult females is
expected to result in a higher risk than adult males because a lower
body weight is used (60 kg), therefore adult females will represent the
U.S. population. These aggregate MOEs do not exceed the Agency's level
of concern for aggregate exposure to food and residential uses. In
addition, intermediate-term DWLOCs were calculated and compared to the
EECs for chronic exposure of halosulfuron-methyl in ground and surface
water. 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 5:

Table 5.-- Aggregate Aggregate Risk Assessment for Intermediate-Term Exposure to halosulfuron-methyl
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Intermediate-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 1,700 100 1.7 0.065 3,300
----------------------------------------------------------------------------------------------------------------
Infants (<1 year old) 1,100 100 1.7 0.065 910
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 1,700 100 1.7 0.065 2,800
----------------------------------------------------------------------------------------------------------------

5. Aggregate cancer risk for U.S. population. Halosulfuron-methyl
is classified as a not likely human carcinogen based on a lack of
evidence of carcinogenicity in male and female mice and rats, and thus
no cancer risk is expected from exposure to halosulfuron methyl.
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 halosulfuron-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

EPA now requires measurement of parent halosulfuron only using the
revised enforcement method, Analytical Method for the Determination of
MON 12000 in Raw Agricultural Commodities and Processed Fractions. The
method was accepted by EPA as an enforcement method and sent to FDA to
be included in PAM II.
The method may be requested from: Calvin Furlow, PRRIB, IRSD
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number:
(703) 305-5229; e-mail address: furlow.calvin@epa.gov.

B. International Residue Limits

There are no established Codex, Canadian, or Mexican maximum
residue limits (MRLs) or tolerances for residues of halosulfuron-methyl
in/on the melon subgroup.

V. Conclusion

Therefore, the tolerance is established for residues of
halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl) amino]
carbonylaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, in
or on melon subgroup at 0.1 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.
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-301200 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 February
25, 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 (1900),
Environmental

[[Page 66339]]

Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
You may also deliver your request to the Office of the Hearing Clerk in
Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. 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 (202) 260-4865.
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 control number OPP-301200, 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). 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

[[Page 66340]]

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: December 13, 2001.
Peter Caulkins,
Director, Registration Division, 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 371.

2. Section 180.479 is amended by alphabetically adding the
following commodity to the table in paragraph (a)(2) to read as
follows:

Sec. 180.479 Halosulfuron-methyl; tolerances for residues.

(a) * * *
(2) * * *

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Melon Subgroup....................................... 0.1
* * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 01-31639 Filed 12-21-01; 8:45 am
BILLING CODE 6560-50-S

Halosulfuron-methyl; Pesticide Tolerance

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