[Federal Register Volume 67, Number 152 (Wednesday, August 7, 2002)]
[Rules and Regulations]
[Pages 51088-51097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19807]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0160; FRL-7189-2]


Metsulfuron Methyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for combined residues 
of metsulfuron methyl and its metabolite methyl 2-[[[[(4-methoxy-6-
methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl]-4-
hydroxbenzoate in or on sorghum, grain, grain at 0.1 part per million 
(ppm); sorghum, grain, forage and sorghum, grain, stover at 0.2 ppm. 
E.I. DuPont de Nemours & Company requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective August 7, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0160, 
must be received on or before October 7, 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-2002-0160 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: James A. Tompkins, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; telephone number: (703) 305-5697; 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
           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 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://

[[Page 51089]]

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-2002-0160. 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 19, 1998 (63 FR 13401) (FRL-5776-
7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
a pesticide petition (PP 3F4215) by E.I. du Pont de Nemours & Company, 
Agricultural Products, P. O. Box 80038, Wilmington, DE 19880-0038. This 
notice included a summary of the petition prepared by E.I. Du Pont de 
Nemours & Company, the registrant. There were no comments received in 
response to the notice of filing.
    The petition requested that 40 CFR 180.428 be amended by 
establishing tolerances for combined residues of the herbicide 
metsulfuron methyl, methyl-2-[[[[ (4-methoxy-6- methyl-1,3,5-triazin- 
2-yl)amino]carbonyl] amino]sulfonyl] benzoate, in or on sorghum grain 
at 0.1 ppm, sorghum forage at 0.2 ppm, and sorghum fodder at 0.2 ppm. 
Since the publication of the notice of filing, the name and address of 
the registrant has changed to E.I. DuPont de Nemours and Company, Crop 
Protection, Stine-Haskell Research Center, P.O. Box 30, Newark, DE 
19714-0030. During the course of the review, the Agency determined the 
commodity listing for grain sorghum should be defined as sorghum, 
grain, forage; sorghum, grain, grain; and sorghum, grain, stover. The 
Agency also determined that the metabolite, methyl-2-[[[[ (4-methoxy-6-
methyl-1,3,5-triazin- 2-yl)amino] carbonyl]amino] sulfonyl]-4-
hydroxybenzoate should be included in the tolerance expression for the 
sorghum, grain commodities. The Agency is also removing the time-
limited tolerances established under paragraph b for sorghum, fodder at 
0.5 ppm, sorghum, forage at 0.3 ppm, and sorghum, grain at 0.4 ppm, 
since these will be replaced by these tolerances.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that`` there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for tolerances for combined residues of metsulfuron methyl 
(methyl 2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino] 
carbonyl]amino]sulfonyl]benzoate) and its metabolite methyl 2-[[[[(4-
methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl]-4-
hydroxybenzoate on sorghum, grain, forage at 0.2 ppm; sorghum, grain, 
grain at 0.1 ppm; and sorghum, grain, stover at 0.2 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 metsulfuron methyl 
are discussed in the following Table 1 as well as the no observed 
adverse effect level (NOAEL) and the lowest observed adverse effect 
level (LOAEL) from the toxicity studies reviewed.

            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
         Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.3100                         90-Day oral         NOAEL = 68/64 (M/F)
                                  toxicity rodents    milligrams/
                                                      kilograms/day (mg/
                                                      kg/day)
                                                     LOAEL = 521/659 (M/
                                                      F) mg/kg/day based
                                                      on transient
                                                      decreases in body
                                                      weight gain.
------------------------------------------------------------------------
870.3200                         21-Day dermal       dermal NOAEL = 125
                                  toxicity            mg/kg/day
                                                     dermal LOAEL = 500
                                                      mg/kg/day based on
                                                      skin lesions
                                                      characterized by
                                                      diffuse/multifocal
                                                      dermatitis.
                                                     systemic NOAEL: 125
                                                      mg/kg/day
                                                     systemic LOAEL: 500
                                                      mg/kg/day based on
                                                      increased
                                                      incidence of
                                                      diarrhea.
------------------------------------------------------------------------

[[Page 51090]]

 
870.3700a                        Prenatal            Maternal NOAEL =
                                  developmental in    250 mg/kg/day
                                  rodents            LOAEL = 1,000 mg/kg/
                                                      day based on
                                                      salivation and
                                                      decreased body
                                                      weight gain-
                                                      compensatory
                                                      increase after
                                                      dosing stopped.
                                                     Developmental NOAEL
                                                       1,000
                                                      mg/kg/day highest
                                                      dose tested (HDT)
                                                     LOAEL > 1000 mg/kg/
                                                      day HDT.
------------------------------------------------------------------------
870.3700b                        Prenatal            Maternal NOAEL = 25
                                  developmental in    mg/kg/day
                                  nonrodents         LOAEL = 1,000 mg/kg/
                                                      day based on
                                                      increased
                                                      mortality,
                                                      decreased body
                                                      weight gains, and
                                                      clinical signs of
                                                      anorexia, red/
                                                      orange urine and /
                                                      or exudate.
                                                     Developmental NOAEL
                                                       700 mg/
                                                      kg/day HDT
                                                     LOAEL > 700 mg/kg/
                                                      day HDT.
------------------------------------------------------------------------
870.3800                         Reproduction and    Parental/Systemic
                                  fertility effects   NOAEL = 34/43(M/F)
                                                      mg/kg/day
                                                     LOAEL = 342/475 (M/
                                                      F) mg/kg/day based
                                                      on decreased
                                                      premating body
                                                      weight gains by F0
                                                      males and females.
                                                     Reproductive NOAEL
                                                       342/
                                                      475 (M/F) mg/kg/
                                                      day HDT
                                                     LOAEL > 342/475 (M/
                                                      F) mg/kg/day HDT.
                                                     Offspring NOAEL  342/475 (M/
                                                      F) mg/kg/day HDT
                                                     LOAEL = 342/475 (M/
                                                      F) mg/kg/day HDT.
------------------------------------------------------------------------
870.4100a                        Chronic toxicity    NOAEL = 25 (M/F) mg/
                                  rodents             kg/day
                                                     LOAEL = 250 (M/F)
                                                      mg/kg/day based on
                                                      decreased body
                                                      weight and body
                                                      weight gain.
------------------------------------------------------------------------
870.4100b                        Chronic toxicity    NOAEL 
                                  dogs                125 (M/F) mg/kg/
                                                      day HDT
                                                     LOAEL = not
                                                      determined
------------------------------------------------------------------------
870.4200                         Carcinogenicity     NOAEL = 25 (M/F) mg/
                                  rats                kg/day
                                                     LOAEL = 250 (M/F)
                                                      mg/kg/day based on
                                                      decreased body
                                                      weight and body
                                                      weight gain.
                                                     (no) evidence of
                                                      carcinogenicity
------------------------------------------------------------------------
870.4300                         Carcinogenicity     NOAEL 
                                  mice                666/836 (M/F) mg/
                                                      kg/day HDT
                                                     LOAEL = not
                                                      determined
                                                     (no) evidence of
                                                      carcinogenicity
------------------------------------------------------------------------
870.5100                         Gene Mutation       Not mutagenic under
                                  Salmo nella         the conditions of
                                  typhimurium, Ames   this study
                                  Test
------------------------------------------------------------------------
870.5375                         Cytogenetics In     Metsulfuron methyl
                                  vitro mammalian     is not a clastogen
                                  chromosome          under the
                                  aberrations-CHO     conditions of this
                                  cells (2 studies)   study.
------------------------------------------------------------------------
870.5385                         In vivo mammalian   Metsulfuron methyl
                                  chromosome          did not induce a
                                  aberrations-rat     significant
                                  bone marrow         increase in
                                                      chromosome
                                                      aberrations in
                                                      bone marrow cells
                                                      when compared to
                                                      the vehicle
                                                      control group.
------------------------------------------------------------------------
870.5395                         In vivo mammalian   Metsulfuron methyl
                                  cytogenics-         is negative at the
                                  micronucleusassay   limit dose for
                                  in mice             clastogenic
                                                      activity in the
                                                      micronucleus assay
                                                      in bone marrow
                                                      cells.
------------------------------------------------------------------------
870.5550                         Other Effects UDS   Metsulfuron methyl
                                  assay in primary    tested negatively
                                  rat hepatocytes/    for UDS in
                                  mammalian cell      mammalian
                                  culture             hepatocytes in
                                                      vivo
------------------------------------------------------------------------

[[Page 51091]]

 
870.7485                         Metabolism and      Overall recovery of
                                  pharmacokinetics    metsulfuron methyl
                                                      among the
                                                      treatment groups
                                                      was acceptable
                                                      (~91.6-103.8 %).
                                                      The primary route
                                                      of excretion was
                                                      via the urine
                                                      which accounted
                                                      for approx. 71-95%
                                                      (78-96% if cage
                                                      wash radioactivity
                                                      is considered)
                                                      among the various
                                                      treatment groups.
                                                      Fecal elimination
                                                      was 4.8-13.3%.
                                                      Excretion was
                                                      almost complete
                                                      within 48 hours.
                                                      Based on time
                                                      course urinary and
                                                      fecal excretion
                                                      data, elimination
                                                      half-lives (males
                                                      and females) were
                                                      estimated to be 13-
                                                      16 hours for Group
                                                      I (single low
                                                      dose), 9-12 hours
                                                      for Group II (21-
                                                      day dietary
                                                      exposure), and 23-
                                                      29 hours for Group
                                                      III (single high
                                                      dose) which
                                                      affirmed notable
                                                      alteration of
                                                      absorption and/or
                                                      excretion
                                                      processes in the
                                                      high-dose group.
                                                     Tissue burdens were
                                                      minimal (generally
                                                      < 0.1% to 1%)
                                                      regardless of
                                                      exposure protocol;
                                                      the
                                                      gastrointestinal
                                                      tract, carcass,
                                                      and skin had the
                                                      highest
                                                      concentrations of
                                                      radioactivity. For
                                                      the single or
                                                      repeated low dose
                                                      groups, the tissue
                                                      content was
                                                      generally >0.03
                                                      ppm. In the high-
                                                      dose group,
                                                      females had
                                                      somewhat higher
                                                      tissue burdens
                                                      (ranging from 0.8
                                                      ppm in brain to
                                                      7.1 ppm in liver
                                                      and 8.0 ppm in
                                                      kidneys) than did
                                                      males (0.1 ppm in
                                                      blood to 1.6 ppm
                                                      in liver and 2.6
                                                      ppm in kidneys).
                                                      No evidence for
                                                      sequestration of
                                                      the test article
                                                      or its
                                                      biotransformation
                                                      products.
                                                     Four metabolites
                                                      and parent were
                                                      recovered in both
                                                      urine and feces in
                                                      all treatment
                                                      groups. Parent
                                                      compound accounted
                                                      for most of the
                                                      urinary and fecal
                                                      radioactivity (77-
                                                      90% and 1.8-6.2%
                                                      of the
                                                      administered dose,
                                                      respectively).
                                                      Metab. I was
                                                      consistent with
                                                      (methyl 2-
                                                      [(amino)sulfonyl]
                                                      benzoate); Metab.
                                                      II - (2-
                                                      [(amino)sulfonyl]-
                                                      benzoic acid); and
                                                      Metab. III was
                                                      consistent with
                                                      (methyl 2-
                                                      [[[(amino)carbonyl
                                                      ]amino] sulfonyl]
                                                      benzoate). Metab.
                                                      I and II appeared
                                                      to result from
                                                      sequential
                                                      hydrolysis
                                                      reactions
                                                      terminating in the
                                                      formation of
                                                      saccharin while
                                                      Metab. III was
                                                      formed by cleavage
                                                      of the two ring
                                                      structures. Total
                                                      metabolites (in
                                                      urine + feces of
                                                      each group)
                                                      accounted for
                                                      approximately 5.4-
                                                      8.2% of the
                                                      administered dose.
                                                      The metabolite
                                                      profiles were
                                                      qualitatively
                                                      similar for urine
                                                      and feces in that
                                                      parent compound
                                                      and the four
                                                      metabolites
                                                      (saccharin,
                                                      Metabolites I, II,
                                                      and III) were
                                                      found in both
                                                      matrices.
------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which the NOAEL from the toxicology study identified as 
appropriate for use in risk assessment is used to estimate the 
toxicological level of concern (LOC). However, the LOAEL is sometimes 
used for risk assessment if no NOAEL was achieved in the toxicology 
study selected. An uncertainty factor (UF) is applied to reflect 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and in the variations in sensitivity among members of the 
human population as well as other unknowns. An UF of 100 is routinely 
used, 10X to account for interspecies differences and 10X for intra 
species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-6 or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer 
= point of departure/exposures) is calculated. A summary of the 
toxicological endpoints for metsulfuron methyl used for human risk 
assessment is shown in the following Table 2:

[[Page 51092]]



  Table 2.--Summary of Toxicological Dose and Endpoints for metsulfuron methyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population       NA                       NA                       An endpoint
 including infants and children                                                           attributable to a
                                                                                          single dose was not
                                                                                          identified.
                                                                                         Quantitation of acute
                                                                                          dietary risk is not
                                                                                          appropriate
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL= 25 mg/kg/day      FQPA SF = 1              Chronic/oncogenicity
                                       UF = 100...............  cPAD = 0.25 mg/kg/day..   study in the rat
                                       Chronic RfD = 0.25 mg/                            LOAEL = 250 mg/kg/day
                                        kg/day.                                           based on decreased
                                                                                          body weight and body
                                                                                          weight gain.
----------------------------------------------------------------------------------------------------------------
Short- and Intermediate-Term           NOAEL=                   LOC for MOE = 100        2-generation
 Incidental Oral (1 to 30 days and 1   34 mg/kg/day...........   (Residential)            reproduction study in
 month to 6 months)                                                                       rats based on
(Residential)........................                                                     decreased premating
                                                                                          (F0) body weights in
                                                                                          male and female rats;
                                                                                          systemic effects were
                                                                                          seen up to 13 weeks at
                                                                                          the LOAEL of 342 mg/kg/
                                                                                          day.
----------------------------------------------------------------------------------------------------------------
Short-, Intermediate-, and Long-Term   NOAEL= 125 mg/kg/day     LOC for MOE = 100        21-day dermal toxicity
 Dermal (1 to 30 days; 1 month to 6                              (Residential)            in rabbits based on an
 months; and > 6 months)                                                                  increased incidence of
(Residential)........................                                                     diarrhea in rabbits at
                                                                                          the LOAEL of 500 mg/kg/
                                                                                          day.
----------------------------------------------------------------------------------------------------------------
Short- and Intermediate-               oral study NOAEL= 34 mg/ LOC for MOE = 100        2-generation
 TermInhalation (1 to 30 days and 1     kg/day                   (Residential)            reproduction study in
 month to 6 months)                    (inhalation absorption                             rats
(Residential)........................   rate = 100%).                                    LOAEL = 342 mg/kg/day
                                                                                          based on decreased
                                                                                          body weights in
                                                                                          premating (F0) animals
                                                                                          for up to 13 weeks.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (6 months to      oral study NOAEL= 25 mg/ LOC for MOE = 100        Chronic/oncogenicity
 lifetime)                              kg/day                   (Residential)            study in the rat
(Residential)........................  (inhalation absorption                            LOAEL = 250 mg/kg/day
                                        rate = 100%).                                     based on decreased
                                                                                          body weight and body
                                                                                          weight gain.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) -
 not likely to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
* 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 180.428) for the combined residues of metsulfuron 
methyl and its metabolite methyl 2-[[[[(4-methoxy-6-methyl-1,3,5-
triazin-2- yl)amino]carbonyl]amino]sulfonyl]-4-hydroxybenzoate, in or 
on a variety of raw agricultural commodities. Tolerances have been 
established for residues of metsulfuron methyl on fat, meat, and meat 
byproducts of cattle, goats, hogs, horses, and sheep at 0.1 ppm; kidney 
of cattle, goats, hogs, horse, and sheep at 0.5 ppm, and milk at 0.05 
ppm. Risk assessments were conducted by EPA to assess dietary exposures 
from metsulfuron 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. No acute dietary endpoint attributable to a single 
dose was identified. Therefore, quantification of acute dietary risk 
was not performed.
    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: Tolerance residue levels, 100% crop treated (CT) 
for all commodities, and DEEM defaults for all processing 
factors. In addition, the chemical iodosulfuron methyl recently 
received a favorable recommendation for tolerances on corn, field, 
grain at 0.03 ppm, and corn, field, stover and forage at 0.05 ppm. 
Since the major metabolite of iodosulfuron methyl is metsulfuron 
methyl, these tolerances were included in the dietary exposure 
assessment.
    iii. Cancer. Since metsulfuron methyl has been classified as ``Not 
likely to be a human carcinogen'', a cancer risk assessment 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 metsulfuron methyl in 
drinking water. Because the Agency does not have comprehensive 
monitoring data, drinking water concentration estimates are made by 
reliance on simulation or modeling taking into account data on the 
physical characteristics of metsulfuron methyl.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), 
to produce estimates of pesticide concentrations in an index reservoir. 
The SCI-GROW model is used to predict pesticide concentrations in 
shallow ground water. For a screening-level assessment for surface 
water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a 
tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that 
uses a specific high-end runoff scenario for pesticides.

[[Page 51093]]

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 metsulfuron methyl they are 
further discussed in the aggregate risk sections in Unit E.
    Based on the PRZM/EXAMS used to estimate the concentration of 
metsulfuron methyl in surface water and FIRST to estimate the 
concentration of metsulfuron methyl as a metabolite of iodosulfuron 
methyl since FIRST has been used in estimating the drinking water 
values for corn use with the proposed label for iodosulfuron methyl and 
SCI-GROW models the EECs of metsulfuron methyl for acute exposures are 
estimated to be 1.37 parts per billion (ppb) for surface water and 
0.104 ppb for ground water. The EECs for chronic exposures are 
estimated to be 0.332 ppb for surface water and 0.104 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).
    Metsulfuron methyl is currently registered for use on the following 
residential non-dietary sites: ornamental turf such as lawns, parks, 
cemeteries, golf courses (fairways, aprons, tees, and roughs) and 
similar non-crop areas, It has been determined that there is a 
potential for exposure in residential settings during the application 
process for homeowners who purchase and use products containing 
metsulfuron methyl. There is also a potential for exposure from 
entering areas previously treated with metsulfuron methyl such as turf 
(i.e., lawns and parks) and golf courses that could lead to exposures 
for adults and children. As a result, risk assessments have been 
completed for both residential handler and postapplication scenarios. 
Based on the use pattern, short-term exposure is expected. The risk 
assessment was conducted using the following residential exposure 
assumptions: The assumptions and factors used in the risk calculations 
for handler exposure scenarios include:
     Exposure factors used to calculate daily exposures to 
handlers are based on applicable data if available. For lack of 
appropriate data, values from a scenario deemed similar enough by the 
assessor might be used.
     The Agency always considers the maximum application rates 
allowed by labels in its risk assessments to consider what is legally 
possible based on the label. If additional information such as average 
or typical rates are available, these values are also used to allow 
risk managers to make a more informed risk management decision.
    The Agency bases calculations for residential risk assessments on 
what would reasonably be treated by homeowners such as the size of the 
lawn, or the size of a garden. This information was used by the Agency 
to define chemical values for handlers which in turn are coupled with 
unit exposure to calculate risks.
    Noncancer risk were calculated using the Margins of Exposure (MOE) 
for two scenarios, (1) low pressure handwand and (2) hose-end sprayer. 
Residential risk assessments apply an additional FQPA safety factor to 
the risk when appropriate, which defines the level of concern. In the 
case of metsulfuron methyl, no additional safety factor (1x) is 
necessary to protect the safety of infants and children in assessing 
metsulfuron methyl risks and exposure.
    Children may also be exposed by incidental non-dietary ingestion of 
pesticide residues on residential lawns from hand to mouth transfer. 
This scenario assumes that pesticide residues are transferred to the 
skin of toddlers playing on recreational or residential lawns and turfs 
and are subsequently ingested as a result of hand-to-mouth transfer. 
The method for estimating postapplication incidental ingestion dose 
from pesticide residues on turf is based on the following assumptions.
     On the day of application 5% of the application rate are 
available on the turfgrass as dislodgeable residue. The 5% transfer 
factor is based on data by Clothier (2000). (Science Advisory Council 
for Exposure Policy #12: Recommended Revisions to the Standard 
Operating Procedures (SOPs) for Residential Exposure Assessments; 
Revised February 22, 2001).
     Postapplication activities are assessed on the same day 
the pesticide is applied since it is assumed that toddlers could play 
on the lawn immediately after application. For subsequent days after 
application, an assumed 10% pesticide dissipation rate is used.
     The median surface area of both hands is 20 cm2 
for a toddler. Since the hand-to-mouth has been defined by the February 
1999 Science Advisory Panel (SAP) as 1 to 3 fingers (5.7 to 17.1 
cm2) a screening level of 20 cm2 was selected 
based on the assumption that each hand-to-mouth event equals 3 fingers 
(Science Advisory Council for Exposure Policy #12: Recommended 
Revisions to the Standard Operating Procedures (SOPs) for Residential 
Exposure Assessments; Revised February 22, 2001).
     It is assumed that there is a one-to-one relationship 
between the dislodgeable residues on the turf and on the surface area 
of the skin after contact.
     The mean rate of hand-to-mouth activity is 20 events/hr 
for toddlers age 2 to 5 years old for short-term exposure. The 1999 SAP 
recommended the use of the 90th percentile value of 20 
events based on reported hourly frequencies of hand-to-mouth events in 
pre school children aged 2 to 5 years observations using video tapes by 
Reed et al. (Science Advisory Council for Exposure Policy #12: 
Recommended Revisions to the Standard Operating Procedures (SOPs) for 
Residential Exposure Assessments; Revised February 22, 2001).
     The duration of exposure for toddlers is assumed to be 2 
hours per day. This is based on the 75\th\ percentile value (i.e., 120 
min/day) for playing on grass for ages 1 to 4 years and 5-11 years 
(Tsang and Klepeis 1996 as cited on pag 15-79 of EPA 1997, Exposure 
Factors Handbook EFH).
     Toddlers (age 3 years) used to represent the 1 to 6 year 
old group, are assumed to weigh 15 kg. This is the mean of the median 
values for male and female children (US EPA 1996a).
     A saliva extraction factor of 50% was used (Science 
Advisory Council for Exposure Policy # 12: Recommended Revisions to the 
Standard Operating

[[Page 51094]]

Procedures (SOPs) for Residential Exposure Assessments; Revised 
February 22, 2001).
    These values were used to calculate the MOE for incidental 
ingestion of pesticide residues from hand to mouth transfer.
    Children (toddlers) may be exposed postapplication through 
ingestion of pesticide treated turfgrass. This scenario assumes that 
turf is ingested by toddlers who play on treated areas (i.e., yards, 
playgrounds). The method for estimating postapplication ingestion 
exposure to pesticide residues in turfgrass is based on the following 
assumptions:
     On the day of application 5% of the application rate are 
available to be ingested. This is assumed to represent an upper-
percentile input.
     Postapplication must be assessed on the same day the 
pesticide is applied because it is assumed that toddlers could play on 
the lawn immediately after application.
     The assumed ingestion rate for grass for toddlers (age 3 
years) is 25 cm2/day. This value is intended to represent 
the approximate area from which a child may grasp a handful of grass. 
This is assumed to represent an upper-percentile input.
     Toddlers (age 3 years), used to represent the 1 to 6 year 
old age group, are assumed to weigh 15 kg (U.S. EPA, 1996).
    These values were then used to calculate the MOE for ingestion of 
pesticide treated turf. Children may be exposed postapplication through 
ingestion of soil from pesticide treated residential areas. This 
scenario assumes that pesticide residues in soil are ingested by 
toddlers who play on treated areas as a result of normal mouthing 
activities. The method for estimating postapplication ingestion 
exposure to pesticide residues in soil is based on the following 
assumptions:
     On the day of application, it is assumed that 100% of the 
application rate are located within the soil's uppermost 1 cm.
     Postapplication must be assessed on the same day the 
pesticide is applied because it is assumed that toddlers could play on 
the lawn or other outdoor treated area immediately after application.
     The assumed soil ingestion rate for children (ages 1-6) is 
100 mg/day. This is the mean soil ingestion rate value recommended by 
EPA for use in exposure/risk assessments (U.S. EPA, 1996).
     Toddlers (age 3 years), used to represent the 1 to 6 year 
old age group, are assumed to weigh 15 kg (U.S. EPA, 1996).
    These values were than used to calculate the MOE for soil ingestion 
of pesticide treated areas.
    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 metsulfuron 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, 
metsulfuron 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 metsulfuron methyl has a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 
FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the 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 quantitative or 
qualitative evidence of increased susceptibility in the pre-natal 
studies in rat and rabbit or in the multi-generation reproduction study 
evaluating pre- and post-natal exposure.
    3. Conclusion. There is a complete toxicity data base for 
metsulfuron methyl and exposure data are complete or are estimated 
based on data that reasonably accounts for potential exposures. EPA 
determined that the 10X safety factor to protect infants and children 
should be removed. The FQPA factor is removed because there is no 
quantitative or qualitative evidence of increased susceptibility in the 
pre-natal studies in rat and rabbit or in the multi-generation 
reproduction study evaluating pre- and post-natal exposure; a 
developmental neurotoxicity study is not required, and there are no 
data deficiencies or residual uncertainties identified in the hazard 
and exposure databases for metsulfuron methyl. The only study 
outstanding for metsulfuron methyl is a 28-day inhalation (nose only) 
study which is required due to the concern for the occupational 
exposure via this route based on current use pattern.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water [e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)]. This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures

[[Page 51095]]

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. Because there was no acute endpoint attributable to 
a single dose identified for metsulfuron methyl, EPA does not expect 
metsulfuron methyl to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
metsulfuron methyl from food will utilize < 1% of the cPAD for the U.S. 
population, < 1% of the cPAD for all infants and <1% of the cPAD for 
children 1-6 years old. Based on the use pattern, chronic residential 
exposure to residues of metsulfuron methyl is not expected. In 
addition, there is potential for chronic dietary exposure to 
metsulfuron methyl in drinking water. After calculating DWLOCs and 
comparing them to the EECs for surface and ground water, EPA does not 
expect the aggregate exposure to exceed 100% of the cPAD, as shown in 
the following Table 3:

           Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to metsulfuron methyl
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                         0.25           <1        0.332        0.104         8700
Children 1-6 years                                      0.25           <1        0.332        0.104         2500
Females 13-50 years                                     0.25           <1        0.332        0.104         7500
Males 13-19 years                                       0.25           <1        0.332        0.104         8700
----------------------------------------------------------------------------------------------------------------

    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).
    Metsulfuron 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 metsulfuron methyl.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 12,000 for children-short term 
aggregate, and 39,000 for adults-short term aggregate. 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 metsulfuron 
methyl in ground and surface water. After calculating DWLOCs and 
comparing them to the EECs for surface and ground water, EPA does not 
expect short-term aggregate exposure to exceed the Agency's level of 
concern, as shown in the following Table 4:

                Table 4.--Aggregate Risk Assessment for Short-Term Exposure to metsulfuron methyl
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Children                                              12,000          100        0.332        0.104        3,400
Adult                                                 39,000          100        0.332        0.104       12,000
----------------------------------------------------------------------------------------------------------------

    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).
    Though residential exposure could occur with the use of metsulfuron 
methyl, the potential intermediate-term exposures were not aggregated 
with chronic dietary food and water exposures because the short- and 
intermediate-term endpoints are the same (NOAEL = 34 mg/kg/day) and the 
short-term aggregate risk assessment which includes the same routes of 
exposure is worst-case and below the Agency level of concern. 
Therefore, based on the best available data and current policies, 
potential risks do not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Since metsulfuron 
methyl has been classified as ``Not likely to be a human carcinogen'', 
metsulfuron methyl is not expected to pose a cancer risk.
    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 metsulfuron methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methods are available for enforcement of tolerances for 
residues of metsulfuron methyl in/on plant and animal commodities. PAM 
Vol. II lists Methods I and III which are respectively capable of 
determining residues of metsulfuron methyl per se (LOQ = 0.02 ppm for 
wheat grain; 0.05 ppm for forage and straw) and combined Metabolites A 
and A1 (LOQ = ppm for grain and forage; 0.1 ppm for straw); Method II 
determines parent compound in ruminant tissues and milk to a lower 
limit of 0.02-0.05 ppm.

B. International Residue Limits

    There are currently no Codex, Canadian, or Mexican maximum residue 
levels (MRLs) for metsulfuron methyl, thus international harmonization 
is not an issue.

C. Conditions

    A 28-day inhalation (nose-only) study is required as a condition of 
registration.

[[Page 51096]]

V. Conclusion

    Therefore, tolerances are established for combined residues of 
metsulfuron methyl, methyl 2-[[[[ (4-methoxy-6-methyl-1,3,5- triazin-2- 
yl)amino]carbonyl] amino]sulfonyl]benzoate and its metabolite methyl 2-
[[[[( 4-methoxy-6-methyl-1,3,5-triazin-2-yl) 
amino]carbonyl]amino]sulfonyl]- 4-hydroxybenzoate in or on sorghum, 
grain, forage at 0.2 ppm; sorghum, grain, grain at 0.1 ppm; and 
sorghum, grain, stover at 0.2 ppm. The text of paragraph (b) is removed 
and reserved.

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-2002-0160 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 
7, 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-2002-0160, 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,

[[Page 51097]]

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: July 24, 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 180.428 is amended as follows:
    i. By alphabetically adding entries for the commodities ``sorghum, 
grain, forage;'' ``sorghum, grain, grain'', and ``sorghum, grain, 
stover'' to the table in paragraph (a)(1) as set forth below.
    ii. The text of paragraph (b) is removed and reserved.


Sec. 180.428  Metsulfuron methyl; tolerances for residues.

    (a) General. (1)   *  *  *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                      *      *      *      *      *
Sorghum, grain, forage...............................                0.2
Sorghum, grain, grain................................                0.1
Sorghum, grain, stover...............................                0.2
                      *      *      *      *      *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 02-19807 Filed 8-6-02; 8:45 am]
BILLING CODE 6560-50-S