[Federal Register Volume 67, Number 157 (Wednesday, August 14, 2002)]
[Rules and Regulations]
[Pages 52866-52873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-20229]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0181; FRL-7192-9]


Chlorsulfuron; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
chlorsulfuron; (2-chloro-N-[(4-methoxy-6-methyl-1,3,5-triazin-2-
yl)aminocarbonyl]benzenesulfonamide) in or on grass, forage and grass, 
hay. E.I. du Pont de Nemours and Company, Inc. 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 August 14, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0181, 
must be received on or before October 15, 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-2002-0181 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: 703-305-6224; e-mail address: 
[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/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently 
under development. To access the OPPTS Harmonized Guidelines referenced 
in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0181. 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 March 8, 2002 (67 FR pages 10722 - 
10727) (FRL-6825-8), 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 6F4752) by 
E.I. du Pont de Nemours and Company, Inc., P.O. Box 30, Newark, 
Delaware 19714-0030. This notice included a summary of the petition 
prepared by E.I. du Pont de Nemours and Company, the registrant. There 
were no comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.405 be amended by 
establishing tolerances for residues of the herbicide chlorsulfuron; 
(2-chloro-N-[(4-methoxy-6-methyl-1,3,5-triazin-2-
yl)aminocarbonyl]benzenesulfonamide), in or on grass, forage at 11.0 
part per million (ppm) and grass, hay at 19.0 ppm.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical

[[Page 52867]]

residue in or on a food) only if EPA determines that the tolerance is 
``safe.'' Section 408(b)(2)(A)(ii) defines ``safe'' to mean that 
``there is a reasonable certainty that no harm will result from 
aggregate exposure to the pesticide chemical residue, including all 
anticipated dietary exposures and all other exposures for which there 
is reliable information.'' This includes exposure through drinking 
water and in residential settings, but does not include occupational 
exposure. Section 408(b)(2)(C) requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for tolerances for residues of chlorsulfuron in or on grass, 
forage at 11.0 ppm and grass, hay at 19.0 ppm. EPA's assessment of 
exposures and risks associated with establishing the tolerances 
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 chlorsulfuron are 
discussed in the following Table 1 as well as the no observed adverse 
effect level and the lowest observed adverse effect level from the 
toxicity studies reviewed.

            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
         Guideline No.              Study Type            Results
------------------------------------------------------------------------
870.3150                        6 Month oral       NOAEL = 18.5 mg/kg/
                                 toxicity in        day
                                 nonrodents        LOAEL = 82.3 mg/kg/
                                                    day based on
                                                    decreased body
                                                    weight and body-
                                                    weight gain.
------------------------------------------------------------------------
870.3700                        Prenatal           Maternal NOAEL = 165
                                 developmental in   mg/kg/day
                                 rodents           LOAEL = 500 mg/kg/day
                                                    based on clinical
                                                    signs, vaginal
                                                    discharge with
                                                    associated alopecia.
                                                   Developmental NOAEL =
                                                    500 mg/kg/day
                                                   LOAEL = 1500 mg/kg/
                                                    day based on
                                                    decreased fetal body
                                                    weight.
------------------------------------------------------------------------
870.3700                        Prenatal           Maternal NOAEL = 75
                                 developmental in   mg/kg/day
                                 nonrodents        LOAEL = 200 mg/kg/day
                                                    based on decreased
                                                    body weight gain.
                                                   Developmental NOAEL =
                                                    200 mg/kg/day
                                                   LOAEL = 400 mg/kg/day
                                                    based on a slight
                                                    increase in visceral
                                                    malformations and
                                                    decreased fetal body
                                                    weight.
------------------------------------------------------------------------
870.3800                        3-Generation       Parental NOAEL = 125
                                 Reproduction in    mg/kg/day
                                 rodents           LOAEL is greater than
                                                    125 mg/kg/day, no
                                                    effects observed.
                                                   Reproductive NOAEL =
                                                    5 mg/kg/day
                                                   LOAEL = 25 mg/kg/day
                                                    based on decreased
                                                    female fertility
                                                   Offspring NOAEL = 125
                                                    mg/kg/day
                                                   LOAEL = 125 mg/kg/
                                                    day, no effects
                                                    observed.
------------------------------------------------------------------------
870.4100                        Chronic toxicity   NOAEL = 60.6 mg/kg/
                                 dogs               day
                                                   LOAEL = 215 mg/kg/day
                                                    based on decreased
                                                    body-weight gain,
                                                    erythrocyte counts
                                                    and hemoglobin
                                                    levels.
------------------------------------------------------------------------
870.4200                        Carcino-genicity   NOAEL = 108 mg/kg/day
                                 mice              LOAEL = 750 mg/kg/day
                                                    based on decreased
                                                    body weight and body-
                                                    weight gain.
                                                   (no) evidence of
                                                    carcinogenicity
------------------------------------------------------------------------
870.4300                        Carcinogenicity    NOAEL = 5 mg/kg/day
                                 rats              LOAEL = 25 mg/kg/day
                                                    based on decreased
                                                    body weight in
                                                    males.
                                                   (no) evidence of
                                                    carcinogenicity
------------------------------------------------------------------------
870.5385                        Cytogenetics       No evidence of
                                                    chromosomal
                                                    aberrations
------------------------------------------------------------------------
870.7485                        Metabolism and     Chlorsulfuron is
                                 pharmacokinetics   rapidly absorbed,
                                                    metabolized, and
                                                    excreted following
                                                    oral exposure. The
                                                    major routes of
                                                    elimination are the
                                                    urine (58% - 72%)
                                                    and feces (20% -
                                                    35%).
------------------------------------------------------------------------


[[Page 52868]]

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. The 3-
generation reproductive toxicity study is classified unacceptable, and 
it is considered a datagap. Reproductive toxicity was observed but was 
of questionable significance in both litters of the F3 
generation, as evidenced by decreased female fertility. Offspring 
toxicity was not observed. This study had numerous deficiencies 
including but not limited to:
    1. No assessment of estrous cyclicity, sperm parameters.
    2. No assessment of male reproductive performance.
    3. Parental animals not subjected to gross pathology or 
histopathology examinations.
    4. No assessment of developmental landmarks.
    5. Pup histopathology evaluations conducted only for the 
F3B generation.
    Although this reproduction study on chlorsulfuron conformed to the 
old guideline requirements, it is unacceptable under the current 
guideline requirement in light of the fact that most of the parameters 
used for FQPA assessment are not provided in the available study. The 
Agency applied a FQPA database uncertainty factor of 3X to account for 
the unacceptable reproduction study. Exposure estimates are upper bound 
and will not underestimate exposure to chlorsulfuron. The 3X FQPA 
database uncertainty factor applies to all dietary and non-dietary 
residential exposure scenarios and no Special FQPA safety factor is 
required.
    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 chlorsulfuron used for human 
risk assessment is shown in the following Table 2:

    Table 2.--Summary of Toxicological Dose and Endpoints for Chlorsulfuron 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       no appropriate endpoint for this exposure scenario was identified
 age
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population           no appropriate endpoint for this exposure scenario was identified
 including infants and children
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL = 5 mg/kg/day      FQPA SF = 1              rat chronic toxicity/
                                       UF = 300...............  cPAD = chronic RfD        carcinogenicity LOAEL
                                       Chronic RfD = 0.02 mg/     FQPA SF =       = 25 mg/kg/day based
                                        kg/day.                  0.02 mg/kg/day.          on decreased body
                                                                                          weight in males
----------------------------------------------------------------------------------------------------------------
Incidental Oral, Short-Term            NOAEL = 75 mg/kg/day     FQPA SF = 1              developmental toxicity
 Residential Only                      UF=300.................  LOC for MOE = 300......   study in rabbits
                                                                                          LOAEL=200 mg/kg/day
                                                                                          based on decreased
                                                                                          body-weight gain
----------------------------------------------------------------------------------------------------------------
Incidental Oral, Intermediate-Term     NOAEL = 75 mg/kg/day     FQPA SF = 1              developmental toxicity
 Residential Only                      UF=300.................  LOC for MOE = 300......   study in rabbits
                                                                                          LOAEL=200 mg/kg/day
                                                                                          based on decreased
                                                                                          body-weight gain
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 7 days)        NOAEL = 75 mg/kg/day     FQPA SF = 1              developmental toxicity
 (Residential)                         UF = 300...............  LOC for MOE = 300         study in rabbits LOAEL
                                                                 (Residential).           = 200 mg/kg/day based
                                                                                          on decreased body-
                                                                                          weight gain
----------------------------------------------------------------------------------------------------------------

[[Page 52869]]

 
Intermediate-Term Dermal (1 week to    NOAEL = 75 mg/kg/day     FQPA SF = 1              developmental toxicity
 several months) (Residential)         UF = 300...............  LOC for MOE = 300         study in rabbits LOAEL
                                                                 (Residential).           = 200 mg/kg/day based
                                                                                          on decreased body-
                                                                                          weight gain
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (several months to    NOAEL = 5 mg/kg/day      FQPA SF = 1              chronic toxicity/
 lifetime) (Residential)               UF = 300 when            LOC for MOE = 300         carcinogenicity study
                                        appropriate).            (Residential).           in rats LOAEL = 25 mg/
                                                                                          kg/day based on
                                                                                          decreased body weight
                                                                                          in males
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 7 days)    NOAEL = 75 mg/kg/day     FQPA SF = 1              developmental toxicity
 (Residential)                         UF = 300...............  LOC for MOE = 300         study in rabbits LOAEL
                                                                 (Residential).           = 200 mg/kg/day based
                                                                                          on decreased body-
                                                                                          weight gain
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week   NOAEL = 75 mg/kg/day     FQPA SF = 1               developmental toxicity
 to several months) (Residential)      UF = 300)..............  LOC for MOE = 300         study in rabbits LOAEL
                                                                 (Residential).           = 200 mg/kg/day based
                                                                                          on decreased body
                                                                                          weight gain
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (several months   NOAEL = 5 mg/kg/day      FQPA SF = 1              chronic toxicity/
 to lifetime) (Residential)            UF = 300)..............  LOC for MOE = 300         carcinogenicity study
                                                                 (Residential).           in rats LOAEL = 25 mg/
                                                                                          kg/day based on
                                                                                          decreased body weight
                                                                                          in males
----------------------------------------------------------------------------------------------------------------
* 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 180.405) for the residues of chlorsulfuron, in or 
on a variety of raw agricultural commodities. Risk assessments were 
conducted by EPA to assess dietary exposures from chlorsulfuron 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. No toxicological endpoint attributable to a single 
exposure was identified in the available toxicology studies. No 
appropriate studies available show any acute dietary effects of 
concern.
    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 Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the chronic 
exposure assessments: Residue levels are at the recommended tolerances 
and 100% crop treated with chlorsulfuron. Results of dietary analyses 
showed exposure to chlorsulfuron consumed no more than 19.3% of the 
cPAD.
    iii. Cancer. Chlorsulfuron was classified as having ``no evidence 
of carcinogenicity'' based upon lack of evidence of carcinogenicity in 
rats and mice. Therefore, a cancer dietary exposure analysis was not 
performed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for chlorsulfuron 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 chlorsulfuron.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The Screening Concentration in Ground Water (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 chlorsulfuron, they are 
further discussed in the aggregate risk sections in Unit III. E. of 
this preamble.

[[Page 52870]]

    Based on the FIRST and SCI-GROW models the EECs of total 
chlorsulfuron residues (both parent and degradation products) for acute 
exposures are estimated to be 59.7 parts per billion (ppb) and for 
chronic exposures are estimated to be 41.3 ppb in surface water. The 
EECs for acute and chronic exposures of chlorsulfuron (parent only) are 
estimated to be 3.5 ppb in 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).
    Chlorsulfuron is currently registered for use on the following 
residential non-dietary sites: Lawns. The risk assessment was conducted 
using the following residential exposure assumptions: Adult handlers 
and adult and toddler postapplication exposure to treated turf. 
Residential exposure risk was assessed using the Residential Exposure 
Assessment Standard Operating Procedures (ResSOPs) standard values and 
assumptions. Adult handler exposure risk was not of concern with MOEs 
ranging between 8,800 and 190,000. Postapplication exposure risks for 
adults and toddlers also exceeded target MOEs, ranging between 770 and 
400,000. Since the ResSOPs ranged between median and high end 
assessments, and the use assessed was for spot treatment, not the 
entire lawn, the residential postapplication exposure risk assessment 
was conservative.
    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 chlorsulfuron 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, 
chlorsulfuron 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 chlorsulfuron 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 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. The toxicology database for 
chlorsulfuron contains acceptable guideline developmental studies which 
show no quantitative or qualitative evidence of increased 
susceptibility following in utero exposure. Susceptibility cannot be 
assessed in the 3-generation reproduction study in rats. The Agency 
determined that a 2-generation reproduction study is required for 
chlorsulfuron.
    3. Conclusion. The existing toxicological database for 
chlorsulfuron, while not complete, supports the establishment of 
permanent tolerances for chlorsulfuron per se and exposure data are 
complete or are estimated based on data that reasonably accounts for 
potential exposures. For dietary exposure estimates, a FQPA safety 
factor of 3 was used. Due to data deficiencies in the toxicology 
database, the Agency determined that an additional 3X database UF is 
needed for the protection of infants and children. An UF of 3X (as 
opposed to a 10X) is adequate because the chronic RfD is based on the 
NOAEL of 5 mg/kg/day established in the Combined Chronic/
Carcinogenicity Study in Rats. This dose (5 mg/kg/day) is 25X lower 
than the highest dose tested (125 mg/kg/day) in the existing 3-
generation Reproduction Study in which the effects noted were 
considered of questionable toxicological significance.

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 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, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA 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, EPA 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. An appropriate endpoint attributable to a single 
dose was not identified, therefore, no acute risk is expected.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
chlorsulfuron from food will utilize no more than 6.6% of the cPAD for 
the U.S. population, 7.3% of the cPAD for all infants and 19.3% of the 
cPAD for children 1-6 years old. Based on the use pattern, chronic

[[Page 52871]]

residential exposure to residues of chlorsulfuron is not expected. 
Since no chronic residential scenarios have been identified, chronic 
DWLOCs for chlorsulfuron were calculated based on residues in food 
alone. 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 Chlorsulfuron
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 cPADmg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                         0.02          6.6         41.3          3.5          654
----------------------------------------------------------------------------------------------------------------
Females 13-50 years old                                 0.02          4.3         41.3          3.5          574
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old                                  0.02         19.3         41.3          3.5          161
----------------------------------------------------------------------------------------------------------------
All Infants                                             0.02          7.3         41.3          3.5          185
----------------------------------------------------------------------------------------------------------------

    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).
    Chlorsulfuron 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 chlorsulfuron.
    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 1,265 for adult males, 1,274 for 
adult females and 722 for toddlers. 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 chlorsulfuron 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 Chlorsulfuron
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Adult Male                                             1,265          300         41.3          3.5        6,674
----------------------------------------------------------------------------------------------------------------
Adult Female                                           1,274          300         41.3          3.5        5,734
----------------------------------------------------------------------------------------------------------------
Toddler                                                  722          300         41.3          3.5        1,461
----------------------------------------------------------------------------------------------------------------

    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). The 
intermediate-term aggregate risk is the same as the short-term 
aggregate risk (Table 4) since the toxicity end points are the same for 
both exposures.
    5. Aggregate cancer risk for U.S. population. The carcinogenic 
potential of chlorsulfuron was classified as no evidence of 
carcinogenicity. Therefore, no cancer risk is expected.
    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 chlorsulfuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Methods are available for the enforcement of tolerances for 
chlorsulfuron residues in/on plant and animal commodities. PAM Vol. II 
lists Methods I and II, High performance liguid chromotography methods 
with photoconductivity detection, for the determination of 
chlorsulfuron residues in plants and livestock commodities and milk.

B. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits, 
therefore, issues of compatibility do not exist.

C. Conditions

    The following data gaps must be fulfilled; a 21-day repeat dermal 
toxicity study, a subchronic inhalation study, and a 2-generation 
reproduction study.

V. Conclusion

    Therefore, tolerances are established for residues of chlorsulfuron 
in or on grass, forage at 11.0 ppm and grass, hay at 19.0 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.

[[Page 52872]]

 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-2002-0181 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 October 
15, 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 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 ID number OPP-2002-0181, 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

[[Page 52873]]

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: July 30, 2002.
Donald R. Stubbs,
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 180.405 is revised to read as follows:


Sec. 180.405  Chlorsulfuron; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of chlorsulfuron (2-chloro-N-[(4-methoxy-6-methyl-1,3,5-
triazin-2-yl)aminocarbonyl]benzenesulfonamide) and its metabolite, 2-
chloro-5-hydroxy-N-[(4-methoxy-6-methyl-1,3,5-triazin-2-
yl)aminocarbonyl] benzenesulfonamide in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, grain..............................................          0.1
Barley, straw..............................................          0.5
Oat, forage................................................         20.0
Oat, grain.................................................          0.1
Oat, straw.................................................          0.5
Wheat, forage..............................................         20.0
Wheat, grain...............................................          0.1
Wheat, straw...............................................          0.5
------------------------------------------------------------------------

    (2) Tolerances are established for residues of chlorsulfuron (2-
chloro-N-[(4-methoxy-6-methyl-1,3,5-triazin-2- yl)aminocarbonyl] 
benzenesulfonamide) in or on the following raw agricultural 
commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................          0.3
Cattle, meat...............................................          0.3
Cattle, meat byproducts....................................          0.3
Goat, fat..................................................          0.3
Goat, meat.................................................          0.3
Goat, meat byproducts......................................          0.3
 Grass, forage.............................................         11.0
Grass, hay.................................................         19.0
Hog, fat...................................................          0.3
Hog, meat..................................................          0.3
Hog, meat byproducts.......................................          0.3
Horse, fat.................................................          0.3
Horse, meat................................................          0.3
Horse, meat byproducts.....................................          0.3
Milk.......................................................          0.1
Sheep, fat.................................................          0.3
Sheep, meat................................................          0.3
Sheep, meat byproducts.....................................          0.3
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved].
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 02-20229 Filed 8-13-02; 8:45 am]
BILLING CODE 6560-50-S