[Federal Register Volume 67, Number 183 (Friday, September 20, 2002)]
[Rules and Regulations]
[Pages 59182-59193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23995]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0243; FRL-7200-8]


Halosulfuron-methyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl)amino] 
carbonyaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate in or 
on asparagus; vegetables, fruiting (except cucurbits), group; bean, 
dry, seed and bean, snap, succulent. Gowan Company and Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality 
Protection Act of 1996.

DATES: This regulation is effective September 20, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0243, 
must be received on or before November 19, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket ID number OPP-2002-0243 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: James A. Tompkins and Hoyt 
Jamerson, Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; telephone number: (703) 305-5687 and (703) 
308-9368, respectively; e-mail address: [email protected] and 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

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

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet home page at http://www.epa.gov/. 
To access this document, on the home page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to theFederal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0243. 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 June 3, 2002 (67 FR 38276) (FRL-7179-2), 
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 1E6322) by Interregional 
Research Project Number 4(IR-4), 681 U.S. Highway 1 South, North 
Brunswick, New Jersey 08902-3390. In addition to 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 FQPA announcing the filing of 
pesticide petitions 0F6169 and 1F6229) by Gowan Company, P.O. Box 5569; 
Yuma, AZ 85366. These notices included a summary of the petitions 
prepared by Gowan Company, the registrant. There were no comments 
received in response to these notices of filing.

[[Page 59183]]

    The petitions requested that 40 CFR 180.479(a) be amended by 
establishing tolerances for residues of the herbicide halosulfuron-
methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl)amino] 
carbonyaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, in or 
on vegetables, fruiting (except cucurbits), group at 0.05 part per 
million (ppm) (PP 0F6169), asparagus at 0.8 ppm (1F6229); and dry bean 
and succulent snap bean at 0.05 ppm (1E6322). The tolerance in or on 
asparagus at 0.8 ppm established by the current action will replace the 
time limited tolerance for asparagus established under Sec.  180.479(b) 
in the Federal Register of December 27, 2001 (66 FR 66778) (FRL-6816-
1).
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances in the Federal Register of November 26, 1997 (62 FR 62961) 
(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 
asparagus at 0.8 ppm; bean, dry, seed at 0.05 ppm; bean, snap, 
succulent at 0.05 ppm and vegetables, fruiting (except cucurbits), 
group at 0.05 ppm. EPA's assessment of exposures and risks associated 
with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by halosulfuron-methyl 
are discussed in Unit II.A. of the final rule on halosulfuron-methyl 
pesticide tolerances in the Federal Register of 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 intraspecies 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 Toxicological Dose and Endpoints for Halosulfuron-methyl for Use In Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Dose (mg/kg/day)  UF/     Hazard Based Special      Endpoint for Risk
          Exposure Scenario                      MOE               FQPA Safety Factor           Assessment
----------------------------------------------------------------------------------------------------------------
                                            Dietary Risk Assessments
----------------------------------------------------------------------------------------------------------------
Acute Dietary (females 13-50 years of  NOAEL = 50                                    1x  Developmental Toxicity
 age)                                                                                      Rabbit

[[Page 59184]]

 
                                       UF = 300\a\                                       LOAEL = 150 mg/kg/day
                                                                                          based on decreased
                                                                                          mean litter size,
                                                                                          increased number of
                                                                                          resorptions (total and
                                                                                          per dam) and increased
                                                                                          postimplantation loss
                                                                                          (developmental
                                                                                          toxicity)
                                       Acute RfD = 0.17 mg/kg/
                                        day
-----------------------------------------------------------------------------------------
Acute Dietary                          NOAEL = N/A                                  N/A  No appropriate dose/
                                                                                          endpoint selected.
general population including infants   UF = N/A
 and children
                                       Acute RfD = N/A
-----------------------------------------------------------------------------------------
Chronic Dietary                        NOAEL = 10                                    1x  Chronic Toxicity - Dog
all populations                        UF = 300\a\                                       LOAEL = 40 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight gains in
                                                                                          females
                                       Chronic RfD = 0.03 mg/
                                        kg/day
-----------------------------------------------------------------------------------------
Incidental Oral                        NOAEL = 50                                    1x  Developmental Toxicity-
                                                                                          Rabbit
Short-Term (1-30 Days)                 UF = 300\a\                                       LOAEL = 150 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight gain, food
                                                                                          consumption, and food
                                                                                          efficiency. (maternal
                                                                                          toxicity)
Residential Only                       MOE = 300
-----------------------------------------------------------------------------------------
Incidental Oral                        NOAEL = 10                                    1x  13 Week Subchronic
                                                                                          Toxicity - Dog
Intermediate-Term (1-6 Months)         UF = 300\a\                                       LOAEL = 40 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight gain and
                                                                                          food efficiency in
                                                                                          females
Residential Only                       MOE = 300
-----------------------------------------------------------------------------------------
                                          Non-Dietary Risk Assessments
----------------------------------------------------------------------------------------------------------------
Dermal                                 Dermal NOAEL = 100                                21-Day Dermal Toxicity
                                                                                          Study - Rat
Short-Term (1-30 days)                                                                   LOAEL = 1000 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight gain in
                                                                                          males
Residential                            MOE = 300                                     1x
-----------------------------------------------------------------------------------------
Dermal\b\                              Oral NOAEL = 10                                   13 Week Subchronic
                                                                                          Toxicity - Dog
Intermediate-Term (1-6 Months)                                                           LOAEL = 40 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight gain and
                                                                                          food efficiency in
                                                                                          females.
Residential                            MOE = 300                                     1x
-----------------------------------------------------------------------------------------
Dermal\b\                              Oral NOAEL= 10                                    Chronic Toxicity - Dog
Long-Term (>6 Months)                                                                    LOAEL = 40 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight gains in
                                                                                          females
Residential                            MOE = 300                                     1x
-----------------------------------------------------------------------------------------
Inhalation\c\                           Oral NOAEL = 50                                  Developmental Toxicity-
                                                                                          Rabbit
Short-Term (1-30 days)                                                                   LOAEL = 150 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight gain, food
                                                                                          consumption, and food
                                                                                          efficiency. (Maternal
                                                                                          toxicity)
Residential                            MOE = 300                                     1x
-----------------------------------------------------------------------------------------
Inhalation\c\                          Oral NOAEL = 10                                   13 Week Subchronic
                                                                                          Toxicity - Dog
Intermediate-Term (1-6 Months)                                                           LOAEL = 40 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight gain and
                                                                                          food efficiency in
                                                                                          females
Residential                            MOE = 300                                     1x
-----------------------------------------------------------------------------------------
Inhalation\c\                          Oral NOAEL = 10                                   Chronic Toxicity - Dog
Long-Term (>6 Months)                                                                    LOAEL = 40 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight gains in
                                                                                          females
Residential                            MOE = 300                                     1x
-----------------------------------------------------------------------------------------
Cancer                                  Classification: ``not likely to be carcinogenic to humans'' by the oral
                                         route, based on no evidence of carcinogenicity from studies in rats and
                                                                          mice
----------------------------------------------------------------------------------------------------------------
\*a\ = UFDB = 300 (10x for inter-species extrapolation and 10 x for intra- species variability, 3x for lack of
  DNT).
\b\ = A 75% dermal absorption factor was used for route to route extrapolation.
\c\ = Absorption via inhalation route is presumed to be equivalent to oral absorption.


[[Page 59185]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.479) for the residues of halosulfuron-methyl, 
in or on a variety of raw agricultural commodities. 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 of 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\TM\) 
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: 100% of the crops with halosulfuron-methyl 
tolerances (both established and proposed) are treated and that all 
commodities contain tolerance level residues when consumed.
    The acute dietary exposure estimates are provided for females 13-50 
years old only. No appropriate endpoint attributable to a single 
exposure was identified for the general U.S. population including 
infants, children and adult males. This assessment concludes that the 
acute dietary exposure estimates are below the Agency's level of 
concern (<100% aPAD) at the 95th exposure percentile for females 13-50 
(<1% of the aPAD). The results are presented in the following Table 2.

  Table 2.--Acute Dietary Exposure Estimates at the 95th Percentile of
                                Exposure
------------------------------------------------------------------------
                                                  Exposure
              Population Subgroup               (mg/kg/day)     % aPAD
------------------------------------------------------------------------
Females 13-50 years old                             0.00068           <1
------------------------------------------------------------------------

    ii. Chronic Exposure. In conducting this chronic dietary risk 
assessment, the DEEM\TM\ 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: 
100% of the crops treated with halosulfuron-methyl tolerances (both 
established and proposed) are treated and that all commodities contain 
tolerance level residues when consumed.
    The tier 1 chronic dietary exposure assessment was conducted for 
all supported halosulfuron-methyl food uses. The chronic dietary 
exposure estimates are presented for the general U.S. population 
including infants, children and adult males in the following Table 3. 
This assessment concludes that the chronic dietary exposure estimates 
are below the Agency's level of concern (<100% cPAD) for the general 
U.S. population (<1% of the cPAD). The most highly exposed population 
subgroup is all infants <1 year old at 2.4% of the cPAD.

         Table 3.--Results of Chronic Dietary Exposure Analysis
------------------------------------------------------------------------
                                                  Exposure
              Population Subgroup               (mg/kg/day)     % cPAD
------------------------------------------------------------------------
U.S. Population (total)                             0.00028           <1
All Infants (<1 year)                               0.00071          2.4
Children 1-6 years                                  0.00052          1.7
Children 7-12 years                                 0.00039          1.3
Females 13-50                                       0.00023           <1
Males 13-19                                         0.00027           <1
Males 20+ years                                     0.00023           <1
Seniors 55+                                         0.00024           <1
------------------------------------------------------------------------

    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. A cancer risk is not expected.
    2. Dietary exposure from drinking water. 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 First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), 
to produce estimates of pesticide concentrations in an index reservoir. 
The SCI-GROW model is used to predict pesticide concentrations in 
shallow groundwater. For a screening-level assessment for surface water 
EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 
model). The FIRST model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. While both FIRST and 
PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS 
model includes a percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to halosulfuron-methyl they are 
further discussed in Unit III.E.
    Based on the FIRST and SCI-GROW models the estimated environmental 
concentrations (EECs) of halosulfuron-methyl for acute exposures are 
estimated to be 105 parts per billion (ppb) for surface water and 0.065 
ppb for ground water. The EECs for chronic exposures are estimated to 
be 105 ppb for surface water and 0.065 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).

[[Page 59186]]

    Halosulfuron-methyl is currently registered for use on the 
following residential non-dietary sites: Application to 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. Application may be by 
commercial applicator or homeowner. The risk assessment was conducted 
using the following residential exposure assumptions: No chemical-
specific exposure data for handler activities were submitted to the 
Agency in support of the registered lawn uses. The Agency`s Draft 
Standard Operating Procedures (SOPs) for Residential Exposure 
Assessments, and Recommended Revisions (Policy Number 11, revised Feb. 
22, 2001), were used as the basis for the residential handler exposure 
calculations. The handler exposure data used in this assessment are 
from the Outdoor Residential Exposure Task Force (ORETF). The task 
force recently submitted proprietary data to the Agency on hose-end 
sprayers, push-type granular spreaders, and handgun sprayers. The ORETF 
data were used in this assessment in place of PHED data for the garden 
hose-end sprayer scenario. The ORETF data were designed to replace the 
present PHED data with higher-confidence, higher quality data that 
contain more replicates than the PHED data for those scenarios.
    Table 4 shows the assumptions and exposure calculations for this 
scenario. For short-term exposure and risk for residential lawn 
applicators (``handlers''), the resulting dermal MOE is 21,000 and the 
inhalation MOE is 7,000,000. The Total MOE of 20,000 for residential 
handlers is well above the target MOE of 300, and therefore, does not 
trigger the Agency's level of concern.

                                Table 4.--Short-Term Handler Exposure and Risk Estimates for Residential Lawn Applicators
--------------------------------------------------------------------------------------------------------------------------------------------------------
PHED Scenario Selected from Draft                                              Acres      ORETF Unit                  Daily
   SOP for Residential Exposure       Exposure Route      Application Rate    Treated      Exposure    Absorption  Dose\1\ (mg/  Short-Term     Total
           Assessments                                       (lb ai/A)      (acres/day)   (mg/lb ai)     Factor      kg/day)       MOE\2\       MOE\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Garden Hose End Sprayer/Liquid     Dermal                            0.062          0.5           11          1.0       0.0043       21,000       20,000
 Open Pour (Mix, Load, and Apply)
                                   Inhalation                        0.062          0.5        0.016          1.0    0.0000071    7,000,000       20,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Daily Dose =[Application Rate (lb ai/A) x Acres Treated (A/day) x Unit Exposure (mg/lb ai handled) x Absorption Factor]/Body Weight (70 kg)
\2\ MOE = NOAEL/Daily Dose; where dermal NOAEL = 100 mg/kg/day, and inhalation NOAEL = 10
\3\ Total MOE = 1 / [(1/dermal MOE) + (1/inhalation MOE)]

    The following postapplication exposure scenarios resulting from 
lawn treatment were assessed: (1) Toddlers' incidental ingestion of 
pesticide residues on lawns from hand-to-mouth transfer, (2) object-to-
mouth transfer from mouthing of pesticide-treated turfgrass, (3) 
incidental ingestion of soil from pesticide-treated residential areas, 
and (4) children's and adult's postapplication dermal exposure. 
Postapplication exposures from various activities following lawn 
treatment are considered to be the most common and significant in 
residential settings. The exposure via incidental ingestion of other 
plant material may occur but is considered negligible.
    The exposure estimates are based on some upper-percentile (i.e., 
maximum application rate, initial amount of transferrable residue and 
duration of exposure) and some central tendency (i.e., surface area, 
hand-to-mouth activity, and body weight) assumptions and are considered 
to be representative of high-end exposures. The uncertainties 
associated with this assessment stem from the use of an assumed amount 
of pesticide available from turf, and assumptions regarding transfer of 
chemical residues and hand-to mouth activity. The estimated exposures 
are believed to be reasonable high-end estimates based on observations 
from chemical-specific field studies and professional judgement.
    The exposure and risk estimates for the residential exposure 
scenarios are assessed for the day of application (day ``0'') because 
it is assumed that toddlers could contact the lawn immediately after 
application. Both short-term and intermediate-term oral and dermal 
exposure are expected, but inhalation exposure is expected to be 
negligible. Risk from short-term and intermediate-term incidental 
ingestion by toddlers is assessed by comparing these exposures to the 
NOAELs of 50 mg/kg/day and 10 mg/kg/day, respectively. Dermal 
postapplication risk was assessed by comparing the exposures to the 
NOAELs of 100 mg/kg/day and 10 mg/kg/day, respectively. The results of 
the exposure calculations are presented in the following Tables 5 
through 8.

                                          Table 5.--Postapplication Dermal Exposure and Risk From Treated Lawns
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Short- /                    Daily Dose\2\ (mg/kg/day)         Dermal MOE\3\
                                       Application  Dislodgeable  Intermediate-Term              -------------------------------------------------------
           Subgroup Exposed            Rate (lb ai/    Foliar      Dermal Transfer     Body Wt
                                            A)       Residue\1\      Coefficient         (kg)      Short-term  Intermediate-   Short-term  Intermediate-
                                                     (ug/cm\2\)       (cm\2\/hr)                                    term                        term
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults                                       0.062         0.035       14,500/7,300           70        0.014        0.0054         7,000         1,800
Children                                     0.062         0.035        5,200/2,600           15        0.024        0.0090         4,200         1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Dislodgeable Foliar Residue\Postapplication day zero\ (ug/cm\2\) = Application rate (lb ai/A) x Fraction of ai Retained on the Foliage (0.05) x [(1-
  Fraction of Residue That Dissipates Daily (0.1)]\Postapplication day\ x 4.54E+8 []g/Lb x 2.47E-8 A/cm\2\ (11.2)
\2\ Daily Dose = [Dislodgeable Foliar Residue x Absorption Factor (1 for short-term, 0.75 for intermediate-term) x 0.001 mg/ug x Dermal Transfer
  Coefficient x Exposure Time (2 hrs/day)]/Body weight

[[Page 59187]]

 
\3\ Dermal MOE = Dermal NOAEL/Daily Dose; where short-term NOAEL = 100 mg/kg/day, and intermediate-term NOAEL = 10 mg/kg/day


                                                                     Table 6.--Postapplication Oral Hand-to-Mouth Exposure and Risk for Children from Treated Lawns
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                    Fraction of ai                           Dislodgeable                             Short-term/                                Daily Dose\2\ (mg/kg/day)                      Oral MOE\3\
      Appl. Rate (lb ai/A)          Retained on the    Saliva Extraction   Foliar Residue\1\   Hand Surface Area   Intermediate-term   Body Weight (kg)  -------------------------------------------------------------------------------
                                        Foliage             Factor            (ug/cm\2\)         (cm\2\/event)     Freq. (events/hr)                          Short-term       Intermediate-term      Short-term       Intermediate-term
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
0.062                             0.05                50%                 0.035               20                  20/9.5              15                  0.00093             0.00044             54,000              23,000
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Dislodgeable Foliar Residue\Postapplication day\ (ug/cm\2\)=Application rate (lb ai/A) x Fraction of ai Retained on the Foliage x (1- Fraction of Residue That Dissipates Daily, 0.10)\Postapplication day\ x 4.54E+8 []g/lb x 24.7E-9 A/cm\2\ (11.2138)
\2\ Daily Dose = (Dislodgeable Foliar Residue (ug/cm\2\) x Hand Surface Area (cm\2\/event) x Extraction factor x Frequency (events/hr) x 0.001 mg/ug x Exposure time (2 hrs/day)]/[Body Weight (kg)]
\3\ Oral MOE = Oral NOAEL/Daily Dose; where Short-term NOAEL = 50 mg/kg/day, and Intermediate-term NOAEL = 10 mg/kg/day


                      Table 7.--Postapplication Oral Object-to-Mouth (Turfgrass) Exposure and Risk for Children from Treated Lawns
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Fraction of                                                                               Oral MOE\3\
                                       ai Retained     Grass       Ingestion Rate   Body Weight  Daily Dose\2\ (mg/-------------------------------------
      Application Rate (lb ai/A)          on the     Residue\1\     (cm\2\/day)         (kg)          kg/day)
                                         Foliage     ug/cm\2\)                                                          Short-term     Intermediate-term
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.062                                         0.20        0.031                 25           15            0.00023            220,000             43,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Grass residue\Postapplication day\ (ug/cm\2\) = Application rate (lb ai/A) x Fraction of ai Retained on the Foliage x (1- Fraction of Residue That
  Dissipates Daily)\Postapplication day\ x 4.54E+8 []g/lb x 24.7E-9 A/cm\2\
\2\ Daily Dose = [Grass reside (ug/cm\2\) x Ingestion rate (cm\2\/day) x 0.001 mg/ug] / [Body Weight (kg)]]
\3\ Oral MOE = Oral NOAEL/Daily Dose; where Short-term NOAEL = 50 mg/kg/day, and Intermediate-term NOAEL = 10 mg/kg/day


                          Table 8.--Postapplication Incidental Soil Ingestion Exposure and Risk for Children from Treated Lawns
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                         Fraction of ai       Soil                                        Daily                  Oral MOE\3\
         Appl. Rate (lb ai/A)           Retained in the    Residue\1\    Ingestion Rate   Body Weight  Dose\2\ (mg/-------------------------------------
                                              Soil           (ug/g)         (mg/day)          (kg)       kg/day)        Short-term     Intermediate-term
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.062                                                  1         0.47                100           15      3.1E-06         16,000,000          3,200,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Soil residue \Postapplication day\ (ug/cm\2\) = Application rate (lb ai/A) x Fraction of ai Retained on the Foliage x (1- Fraction of Residue That
  Dissipates Daily) \Postapplication day\ x 4.54E+8 []g/lb x 24.7E-9 A/cm\2\ x 0.67 cm\3\/g soil
\2\ Daily Dose = [Soil reside (ug/g) x Ingestion rate (mg/day) x 0.000001 g/ug] / [Body Weight (kg)]]
\3\ Oral MOE = Oral NOAEL/Daily Dose; where Short-term NOAEL = 50 mg/kg/day, and Intermediate-term NOAEL = 10 mg/kg/day

    Both short-term and intermediate-term MOEs for each scenario are 
above the target MOE of 300, and are not of concern.
    When a common effect (i.e., decreased body weight gain) is observed 
in those studies selected for the endpoints for all routes of exposure; 
MOEs are to be combined where appropriate. Aggregate residential risk 
was assessed for adults and children (Tables 9 and 10). For children, 
short-term and intermediate-term aggregate risk was assessed based on 
postapplication dermal and oral exposure. For adults, short-term 
aggregate residential risk was assessed based on exposure through 
application (handler) and postapplication dermal exposure. Intermediate 
aggregate risk for adults was not assessed because the application of 
halosulfuron-methyl is not expected to occur for more than 30 days. The 
Total MOEs resulting from the combined MOEs for both adults and 
children, are also above the target MOE of 300, and are not of concern.

                                     Table 9.--Adult's Aggregate Exposure and Risk Estimates from Residential Lawns
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Acres      PHED Unit    Short-term
              Adult's Scenario                       Exposure Route         Rate (lb ai/   Treated      Exposure    Daily Dose   Short-term  Total Short-
                                                                               acre)     (acres/day)   (mg/lb ai)  (mg/kg/day)      MOE        term MOE
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. Mix/load and broadcast application of     dermal                               0.062          0.5           30       0.0043       21,000        5,200
 liquid formulation (garden hose-end
 sprayer)
                                             inhalation                           0.062          0.5        0.016    0.0000071    7,000,000        5,200
-----------------------------------------------------------------------------------------
2. Postapplication exposure                  dermal                               0.062          N/A          N/A        0.014        7,000        5,200
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 59188]]


                                   Table 10.--Children's Aggregate Exposure and Risk Estimates from Residential Lawns
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Children's      Short-Term  Intermediate                                                   Total
         TTR/GR/SR0 (ug/cm\2\ or g)\1\           ScenariosExposure  PDR\0-norm\   PDR\0-norm\   Short-Term  Intermediate-Term  Total Short- Intermedite-
                                                       Route        (mg/kg/day)   (mg/kg/day)      MOE             MOE           Term MOE     term MOE
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) Dermal contact                                        0.035           0.024        0.0090        4,200              1,100        3,800         1,000
(2) Hand-to-mouth                                         0.035         0.00093       0.00044       54,000             23,000        3,800         1,000
(3) Mouth grass                                            0.14         0.00023       0.00023      220,000             43,000        3,800         1,000
(4) Soil ingestion                                        0.047          3.1E-6        3.1E-6   16,000,000         3,2000,000        3,800         1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ TTR=turf transferable residue on the ``0''; GR=gras residue on the day ``0''; SR0=soil residue on the day ``0.''
\2\ PDR 0-norm = potential doe rate on day ``0.''

    Halosulfuron-methyl may be used on turf at recreational use sites, 
and, therefore may result in postapplication exposure to adults and 
children involved in recreational activities. Exposures to adults and 
children from the use of halosulfuron-methyl at recreational use sites 
are assumed to be the same as those assessed for residential use sites, 
and therefore, a separate recreational exposure assessment was not 
included. Refer to section 4.4 of this risk assessment for details on 
assumptions, input variables and risk estimates for residential use 
sites. Residential turf exposure assessment results in what are 
considered upper bound risk estimates. Therefore, it is not expected 
that the upper bound residential exposure scenario would occur on the 
same day as an upper bound recreational exposure scenario. Exposure 
from these two exposure scenarios are not aggregated. Rather, the 
residential risk estimate should serve as an upper bound for both 
residential and recreational exposure.
    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 in 
the Federal Register of November 26, 1997 (62 FR 62961) (FRL-5754-7).

D. Safety Factor for Infants and Children

    1.In general. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of young rats in the reproduction study with 
halosulfuron-methyl. Although there is qualitative evidence of 
increased susceptibility in the prenatal developmental studies in rats 
and rabbits, the Agency did not identify any residual uncertainties 
after establishing toxicity endpoints and traditional uncertainty 
factors to be used in the risk assessment of halosulfuron-methyl.
    3. Conclusion. There is a complete toxicity data base for 
halosulfuron-methyl except for a developmental neurotoxicity study and 
exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. EPA determined that, based 
on reliable data, an additional database uncertainty factor of 3X is 
necessary to protect the safety of infants and children in assessing 
halosulfuron-methyl exposures and risks. This factor is necessary to 
address a data deficiency for the developmental neurotoxicity study. 
The additional uncertainty factor of 3X is incorporated into the 
numerical expression for the acute and chronic RfD and PAD (aPAD and 
cPAD) and applied to all dietary and residential (non-dietary) exposure 
scenarios. For residential assessments, an MOE of 300 (10X for 
interspecies extrapolation, 10X for intraspecies variation, and the 
additional database uncertainty factor of 3X) is required.
    No Special FQPA Safety Factor is necessary to protect the safety of 
infants and children in assessing halosulfuron-methyl exposure and 
risks because:
    i. There is no evidence of increased susceptibility of young rats 
in the reproduction study with halosulfuron-methyl. Although there is 
qualitative evidence of increased susceptibility in the prenatal 
developmental studies in rats and rabbits, the Agency did not identify 
any residual uncertainties after establishing toxicity endpoints and 
traditional uncertainty factors to be used in the risk assessment of 
halosulfuron-methyl.
    ii. There are no residual uncertainties identified in the exposure 
databases. The dietary (food and drinking water) exposure assessments 
will not underestimate the exposure (postapplication exposure to 
children as well as incidental oral exposure to toddlers) and risks 
posed by halosulfuron-methyl.
    Recently, EPA has received objections to a tolerance it established 
for residues of halosulfuron-methyl in or on the melon subgroup (66 FR 
66786, December 26, 2001) and an emergency exemption for asparagus (66 
FR 66778, December 27, 2001). The objections were filed by the Natural 
Resources Defense Council (NRDC) and raised several issues regarding 
aggregate exposure estimates and the additional safety factor for the 
protection of infants and children. NRDC's objections raise complex 
legal, scientific, policy, and factual matters and EPA has initiated a 
public comment period on them in the Federal Register of June 19, 2002 
(67 FR 41628) (FRL-7167-7), which ends on September 17, 2002. Although 
that proceeding remains ongoing, prior to

[[Page 59189]]

acting on this current tolerance action, EPA reviewed the halosulfuron-
specific objections raised by NRDC and has addressed them below.
    In reference to NRDC`s statements that the Agency erred by not 
retaining the additional 10X children's safety factor in light of the 
data gap for developmental neurotoxicity study, the Agency re-reviewed 
its determination that a different safety factor, 3X, would be safe for 
infants and children. Taking into account the lack of the developmental 
neurotoxicity study, EPA concluded that an additional traditional 
Database Uncertainty Factor of 3X is needed for all dietary and 
residential (non-dietary) exposure scenarios until the data are 
received and evaluated. An uncertainty factor of 3X (as opposed to a 
higher value) was viewed to be adequate because the doses selected for 
dietary and non-dietary risk assessments would address the concerns for 
the alterations of the fetal nervous system seen in the developmental 
toxicity study in rats and provide a large margin of safety in regard 
to any uncertainty arising from the lack of a developmental 
neurotoxicity study. The NOAEL of 50 mg/kg/day (used for acute dietary, 
short-term incidental oral and inhalation risk assessments) and the 
NOAEL of 10 mg/kg/day (used for chronic dietary and intermediate-term 
incidental oral, dermal and inhalation risk assessments) are 5X and 25X 
lower, respectively, than the NOAEL of 250 mg/kg/day in the rat 
developmental study where alterations of the fetal nervous system were 
seen at 750 mg/kg/day (LOAEL). It was these alterations of the fetal 
nervous system seen at 750 mg/kg/day in the rat developmental study 
that caused EPA to require submission of a developmental neurotoxicity 
study. Thus, in combination with the 3X database uncertainty factor, 
the doses selected for risk assessment provide a 15X (acute) and 75X 
(chronic) margin of safety with regard to observed developmental 
neurotoxic effects. Consequently, based on the available data, use of a 
3X factor instead of a 10X factor will provide an adequate margin of 
safety for the protection of infants and children.
    NRDC also claimed that there were several other data gaps 
necessitating retention of the additional 10X safety factor for the 
protection of infants and children. NRDC claimed that no cancer risk 
assessment or short-term or intermediate-term residential risk 
assessments had been conducted. NRDC's allegations in this regard are 
contradicted by the Federal Register notice establishing the 
halosulfuron-methyl tolerances. EPA did assess the cancer risk posed by 
halosulfuron-methyl and concluded that ``no cancer risk is expected 
from exposure to halosulfuron-methyl.'' (66 FR 66333, 66338, December 
26, 2001). This conclusion was based on EPA's qualitative conclusion 
that halosulfuron-methyl is not likely to be a human carcinogen. Id. 
Having concluded that, as a qualitative matter, halosulfuron-methyl is 
not likely to be a human carcinogen EPA did not perform a quantitative 
cancer risk assessment, as such risk assessment would not be 
scientifically justified. EPA's statement earlier in the Federal 
Register notice regarding not conducting a cancer risk assessment 
referred to the fact that a quantitative assessment was unnecessary. 
Id. at 66336. Short-term and intermediate-term risk residential risk 
assessments were performed and considered by the Agency. Id. at 66337-
66338.

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 USEPA Office of Water are used to calculate DWLOCs 
21/70 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, the Office of Pesticide Programs (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 Unit 
III.C., Exposure Assessment, for acute exposure, the acute dietary 
exposure from food to halosulfuron-methyl will occupy <1% of the aPAD 
for females 13 years and older. The acute dietary exposure estimates 
are provided for females 13-50 years old only. No appropriate endpoint 
attributable to a single exposure was identified for the general U.S. 
population including infants, children, and adult males. In 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 
11:

                                     Table 11.--Aggregate Risk Assessment for Acute Exposure to Halosulfuron-methyl
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Food Exposure (mg/ Surface Water EEC   Ground Water EEC
                   Population Subgroup                        aPAD (mg/kg)         kg/day)             (ppb)              (ppb)        Acute DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13-50 years old                                                 0.17            0.00068                105              0.065               5100
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 59190]]

    2. Chronic risk. Using the exposure assumptions described in Unit 
III.C., Exposure Assessment, for chronic exposure, EPA has concluded 
that exposure to halosulfuron-methyl from food will utilize <1% of the 
cPAD for the U.S. population, 2.4% of the cPAD for all infants <1 year 
old and 1.7% of the cPAD for children 1-6 years . Based 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 12:

                             Table 12.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Halosulfuron-methyl
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Food Exposure (mg/ Surface Water EEC   Ground Water EEC    Chronic DWLOC
                   Population Subgroup                       cPAD mg/kg/day        kg/day)             (ppb)              (ppb)              (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population                                                         0.03            0.00028                105              0.065              1,000
All infants (<1 year old)                                               0.03            0.00071                105              0.065                300
Females 13-50 years old                                                 0.03            0.00023                105              0.065                900
Males 13-19 years old                                                   0.03            0.00027                105              0.065              1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    here3. 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 Unit III.C., Exposure 
Assessment, for short-term exposures, EPA has concluded that food and 
residential exposures aggregated result in aggregate MOEs of 5200 for 
adults from exposure to residential lawns including MOEs of 21,000 for 
dermal, 7,000,000 for inhalation and 7,000 for postkapplication dermal; 
3800 for children from exposure to residential lawns including MOEs of 
4,200 for dermal contact, 54,000 for hand-to-mouth, 220,000 for 
mouthing grass, and 16,000,000 for soil ingestion. 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 13:

                                   Table 13.--Aggregate Risk Assessment for Short-Term Exposure to halosulfuron-methyl
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Aggregate MOE
                   Population Subgroup                          (Food +        Aggregate Level   Surface Water EEC   Ground Water EEC   Short-Term DWLOC
                                                              Residential)     of Concern (LOC)        (ppb)              (ppb)              (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                                                         5300                300                105              0.065               5500
Females 13-50 years old                                                 4700                300                105              0.065               4700
All infants (<1 year old)                                               3600                300                105              0.065               1500
Males 13-19 years old                                                   5400                300                105              0.065               5500
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 Unit III.C., Exposure 
Assessment, for intermediate-term exposures, EPA has concluded that 
food and residential exposures aggregated result in aggregate MOEs of 
1,000 for children from residential lawns including MOEs of 1100 for 
dermal contact, 23,000 for hand-to-mouth, 43,000 for mouthing grass, 
and 3,200,000 for soil ingestion. 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 14:

                               Table 14.--Aggregate Risk Assessment for Intermediate-Term Exposure to Halosulfuron-methyl
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Aggregate MOE
                   Population Subgroup                          (Food +        Aggregate Level   Surface Water EEC   Ground Water EEC  Intermediate-Term
                                                              Residential)     of Concern (LOC)        (ppb)              (ppb)           DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants (<1 year)                                                    960                300                105              0.065                230
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 59191]]

    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. 
Accordingly, exposure to halosulfuron-methyl is not expected to pose a 
cancer risk to humans.
    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

    An adequate analytical enforcement method is available to enforce 
the proposed tolerance for residues of halosulfuron-methyl in or on 
asparagus; vegetables, fruiting (except cucurbits), group; bean, dry, 
seed and bean, snap succulent. The method used to validate residues of 
halosulfuron-methyl is the ``Analytical Method for the Determination of 
MON 12000 in Raw Agricultural Commodities and Processed Fractions,'' 
RES-109-97-4, which has been approved by the Agency for enforcement of 
tolerances for halosulfuron-methyl per se in plant commodities and has 
been sent to FDA for publication in PAM II. The method limit of 
quantification (LOQ) was 0.05 ppm.
    An adequate analytical method is available to enforce the 
established tolerances for secondary residues in livestock commodities. 
The Agency-approved analytical method for livestock commodities is 
Monsanto method RES-046-93. The method quantifies halosulfuron-methyl 
and the 3-chlorosulfonamide acid metabolite expressed as parent 
equivalents. The limit of quantitation is 0.01 ppm.
    Adequate enforcement methodology (example: gas chromotography) is 
available to enforce the tolerance expression. The method may be 
requested from: Paul Golden, Analytical Chemistry Lab. Office of 
Pesticide Programs, Environmental Protection Agency, Environmental 
Science Center, 701 Maples Road, Fort Mead, MD 20755-5350; telephone 
number: (410) 305-2960; e-mail address: [email protected].

B. International Residue Limits

    No Codex, Canadian, or Mexican maximum residue levels (MRL) have 
been established for residues of halosulfuron-methyl in/on asparagus, 
bean, dry, seed, and bean, snap, succulent, tomatoes, and bell or non-
bell peppers. International harmonization is therefore not an issue.

V. Conclusion

    Therefore, the tolerances are 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 asparagus at 0.8 ppm; vegetables, fruiting (except cucurbits), 
group at 0.05 ppm; bean, dry, seed at 0.05 ppm and bean, snap, 
succulent at 0.05 ppm. Paragraph (b) of Sec.  180.479 is removed and 
reserved since the tolerance established in this document for asparagus 
at 0.8 ppm replaces the tolerance for asparagus and the tolerance for 
tomato is removed because the vegetables, fruiting (except cucurbits), 
group at 0.05 ppm includes tomatoes.

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 ID number OPP-2002-0243 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
19, 2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921 
Jefferson Davis Hwy, Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [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

[[Page 59192]]

inclusion in the official record that is described in Unit I.B.2. Mail 
your copies, identified by docket ID number OPP-2002-0243, 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 Government and Indian tribes, 
as specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

VIII. Submission to Congress and the Comptroller General

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

List of Subjects in 40 CFR Part 180

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


    Dated: September 12, 2002.
Peter Caulkins,
Acting 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 as follows:
    i. By revising the section heading and alphabetically adding the 
following

[[Page 59193]]

commodities to the table in paragraph (a)(2).
    ii. The text of paragraph (b) is removed and reserved.


Sec.  180.479  Halosulfuron-methyl; tolerances for residues.

    (a) General. * * *
    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Asparagus..................................................          0.8
Bean, dry, seed............................................         0.05
Bean, snap, succulent......................................         0.05
                                * * * * *
Vegetables, fruiting (except cucurbits), group.............         0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *

[FR Doc. 02-23995 Filed 9-19-02; 8:45 am]
BILLING CODE 6560-50-S