[Federal Register Volume 66, Number 247 (Wednesday, December 26, 2001)]
[Rules and Regulations]
[Pages 66333-66340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31639]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301200; FRL-6816-8]
RIN 2070-AB78


Halosulfuron-methyl; Pesticide Tolerance

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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

------------------------------------------------------------------------
                                                 Examples of 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 (MOEcancer = 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 g/L and 1.7 g/L, 
respectively. Based on the SCI-GROW model the estimated EECs of

[[Page 66336]]

halosulfuron-methyl for groundwater is estimated to be 0.065 
g/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: [email protected].

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 [email protected], 
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: [email protected]. 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