[Federal Register Volume 68, Number 63 (Wednesday, April 2, 2003)]
[Rules and Regulations]
[Pages 15945-15958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7800]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0046; FRL-7299-8]


S-Metolachlor; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of S-metolachlor Acetamid, 2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-
methoxy-1-methylethyl)-, (S) and its metabolites, determined as the 
derivatives, 2-(2-ethyl-6-methylphenyl)amino-1-propanol and 4-(2-ethyl-
6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, each expressed as 
the parent compound S-metolachlor in or on the raw agricultural 
commodities grass forage, grass hay, spinach, sugar beet, sugar beet 
molasses, sugar beet tops, sunflower seed, sunflower meal, and tomato. 
The Interregional Research Project No. 4 (IR-4) and Syngenta Crop 
Protection requested theses tolerances 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 April 2, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0046, 
must be received on or before June 2, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Joanne Miller, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; 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 potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacture. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (32532)
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
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 Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0046. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under 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.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of January 29, 2003, (68 FR 4470-4475) 
(FRL-7281-3), 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 pesticide petitions (PP 6E4638, 8E5011, 6F6751, and 7F4897) 
by the Interregional Research Project No. 4 (IR-4), and Syngenta Crop 
Protection, New Jersey Agricultural Experiment Station, P.O. Box 231, 
Rutgers University, New Brunswick, NJ 08903 and 410 Swing Road, 
Greensboro, NC 27419. That notice included a summary of the petition 
prepared by IR-4 and Syngenta, the registrant. There were no comments 
received in response to the notice of filing.
    The petition requested that 40 CFR 180.368(a) be amended by 
establishing a tolerance for combined residues of the herbicide S-
metolachlor Acetamid, 2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-
1-methylethyl)-, (S) and its metabolites, determined as the 
derivatives, 2-(2-ethyl-6-methylphenyl)amino-1-propanol and 4-(2-ethyl-
6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, each expressed as 
the parent compound in or on the raw agricultural commodities grass 
forage at 12.0 parts per million (ppm), grass hay at 0.02 ppm, spinach 
at 0.5 ppm, sugar beet at 0.5 ppm, sugar beet dried pulp at 1.0 ppm, 
sugar beet molasses at 3.0 ppm, sugar beet tops at 15.0 ppm, sunflower 
at 0.5 ppm, sunflower meal at 1.0 ppm, and tomato at 0.1 ppm.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is 
a

[[Page 15946]]

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) of the FFDCA 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 of the FFDCA 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) of the FFDCA, 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) of the FFDCA, for a tolerance for combined residues of 
Acetamid, 2-chloro-N-(2-ethyl-6-methylphenyl)-N-methoxy-1-methylethyl)-
, (S) and its metabolites, determined as the derivatives, 2-(2-ethyl-6-
methylphenyl)amino-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-
5-methyl-3-morpholinone, each expressed as the parent compound in or on 
the raw agricultural commodities; grass forage at 10.0 ppm; grass hay 
at 0.02 ppm; spinach at 0.5 ppm; sugar beet roots at 0.5 ppm; sugar 
beet molasses at 3.0 ppm; sugar beet tops at 15.0 ppm; sunflower seeds 
at 0.5 ppm; sunflower meal at 1.0 ppm; and tomato at 0.1 ppm. EPA's 
assessment of exposures and risks associated with establishing the 
tolerance follows.

A. Toxicological Profile

    Metolachlor is a chloroacetanilide herbicide that was first 
registered for use in 1976. Racemic metolachlor consists of 50% each of 
the R-enantiomer (CGA 77101) and the S-enantiomer (CGA 77102, or alpha 
metolachlor). The S-enantiomer is the herbicidally active isomer. S-
metolachlor is a racemic mixture comprised of 88% S-enantiomer and 12% 
R-enantiomer. Toxicity data has been submitted on both metolachlor and 
S-metolachlor. The Agency has determined that S-metolachlor has either 
comparable or decreased toxicity as compared to racemic metolachlor.
    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 metolachlor are 
discussed in Table 1a below as well as the no-observed-adverse-effect-
level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from 
the toxicity studies reviewed.

               Table 1a.--Subchronic, Chronic, and Other Toxicity for Metolachlor (PC code 108801)
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity        NOAEL = 210 milligram/kilogram/day (mg/kg/
                                          rodents                     day) for males
                                                                     LOAEL for males was not established
                                                                     NOAEL = 23.4 mg/kg/day for females
                                                                     LOAEL =259 mg/kg/day for females based on
                                                                      decreased body weight/body weight gain
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity in     NOAEL =8.77 mg/kg/day
                                          nonrodents                 LOAEL = 29.42 mg/kg/day based on decreased
                                                                      body weight gain
----------------------------------------------------------------------------------------------------------------
870.3200                                 21-28 day dermal            Systemic NOAEL = 1,000 mg/kg/day
                                                                     Systemic LOAEL was not established
                                                                     dermal irritation NOAEL was not established
                                                                     dermal irritation LOAEL = 10 mg/kg/day
                                                                      based on very slight erythema, dry skin
                                                                      and fissuring (one animal)
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   Maternal NOAEL = 300 mg/kg/day
                                          rodents                    Maternal LOAEL = 1,000 mg/kg/day based on
                                                                      an increased incidence of death, clinical
                                                                      signs of toxicity (clonic and/or toxic
                                                                      convulsions, excessive salivation, urine-
                                                                      stained abdominal fur and/or excessive
                                                                      lacrimation) and decreased body weight
                                                                      gain.
                                                                     Developmental NOAEL = 300 mg/kg/day
                                                                     Developmental LOAEL =1000 mg/kg/day based
                                                                      on slightly decreased number of
                                                                      implantations per dam, decreased number of
                                                                      live fetuses/dam, increased number of
                                                                      resorptions/dam and significant decrease
                                                                      in mean fetal body weight
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   Maternal Toxicity NOAEL = 120 mg/kg/day
                                          nonrodents                 Maternal Toxicity LOAEL = 360 mg/kg/day
                                                                      based on an increased incidence of
                                                                      clinical observations (persistent
                                                                      anorexia) and decreased body weight gain
                                                                     Developmental Toxicity NOAEL = 360 mg/kg/
                                                                      day
                                                                     Developmental Toxicity LOAEL was not
                                                                      established
----------------------------------------------------------------------------------------------------------------

[[Page 15947]]

 
870.3800                                 Reproduction and fertility  Parental Toxicity NOAEL = 75.8 mg/kg/day
                                          effects                     (F0 males/females: 75.8/85.7 mg/kg/day; F1
                                                                      males/females: 76.6/84.5 mg/kg/day).
                                                                     Parental LOAEL was not established
                                                                     Reproductive toxicity NOAEL = 75.8 mg/kg/
                                                                      day (F0 males/females: 75.8/85.7 mg/kg/
                                                                      day; F1 males/females: 76.6/84.5 mg/kg/
                                                                      day).
                                                                     Reproductive toxicity LOAEL was not
                                                                      established
                                                                     Offspring NOAEL = 23.5 mg/kg/day (F0 males/
                                                                      females: 23.5/ 26.0 mg/kg/day; F1 males/
                                                                      females: 23.7/25.7 mg/kg/day)
                                                                     Offspring LOAEL = 75.8 mg/kg/day based on
                                                                      F0 males/females: 75.8/85.7 mg/kg/day; F1
                                                                      males/females: 76.6/84.5 mg/kg/day) based
                                                                      on decreased body weight.
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity dogs       NOAEL = 9.7 mg/kg/day for females
                                                                     LOAEL = 33mg/kg/day for females based on
                                                                      decreased body weight
                                                                     NOAEL =32.7 mg/kg/day for males.
                                                                     LOAEL for males was not established
----------------------------------------------------------------------------------------------------------------
870.4300                                 Chronic Toxicity/           NOAEL = 15 mg/kg/day for females
                                          Carcinogenicity in         LOAEL = 150 mg/kg/day for females based on
                                          Rodents                     slightly decreased body weight gain and
                                                                      food consumption.
                                                                     The NOAEL =150 mg/kg/day for males.
                                                                     The LOAEL was not established for males.
                                                                     Administration of doses up to 3,000 ppm
                                                                      (150 mg/kg/day) was associated with
                                                                      statistically significant increases in
                                                                      liver adenomas and combined adenoma/
                                                                      carcinoma in female rats. In male rats,
                                                                      there was a statistically significant
                                                                      trend but not pair-wise significance for
                                                                      liver tumors.
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity mice        NOAEL = 150 mg/kg/day
                                                                     LOAEL = 450 mg/kg/day based on possible
                                                                      treatment-related deaths in females and
                                                                      decreased body weight/body weight gain in
                                                                      males and females
                                                                     no evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation -bacterial    negative up to cytotoxic doses (1,000 [mu]g/
                                          reverse mutation            plate)
----------------------------------------------------------------------------------------------------------------
870.5300                                 Gene mutation - mouse       no effect on the incidence of mutations in
                                          lymphoma                    the presence or absence of metabolic
                                                                      activation
----------------------------------------------------------------------------------------------------------------
870.5395                                 Cytogenetics Micronucleus   no effect of treatment on incidence of
                                          assey in Chinese            micronuclei induction
                                          hampsters
----------------------------------------------------------------------------------------------------------------
870.5450                                 Cytogenetics dominant       no effect on embryonic death, pre- and post-
                                          lethal assey in mice        implantation or fertility rates in mated
                                                                      females
----------------------------------------------------------------------------------------------------------------
870.5550                                 Other Effects DNA Damage/   negative
                                          Repair in rat hepatocytes
----------------------------------------------------------------------------------------------------------------
870.5550                                 Other Effects DNA Damage/   negative
                                          Repair in human
                                          fibroblasts
----------------------------------------------------------------------------------------------------------------
870.5550                                 Other Effects Unscheduled   negative for induction of UDS; however,
                                          DNA synthesis in rat        significant increases in percentage of
                                          hepatocytes                 cells in S-phase were observed in females
                                                                      dosed at 500 mg/kg (but not at 1,000 or
                                                                      1,500 mg/kg) and sacrificed at 15 hours
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              The major metabolic pathway proposed from
                                          pharmacokinetics            analysis of urinary as well as fecal
                                          Unacceptable                metabolites is one of cleavage of the
                                                                      ether bond and subsequent oxidation to the
                                                                      carboxylic acid, as well as hydrolytic
                                                                      removal of the chlorine atom. Conjugation
                                                                      of CGA 24705 or metabolites with gluronic
                                                                      acid or sulfate does not appear to occur.
                                                                     Aqueous extractable urinary radioactivity
                                                                      contained 58% of the total urinary
                                                                      radioactivity and was composed of 5
                                                                      different radioactive fractions, which
                                                                      were not identified.
                                                                     Current guideline recommendations as to
                                                                      dose levels and use of both sexes in
                                                                      metabolism studies were not followed.
                                                                      Thus, whether the metabolic pattern is
                                                                      altered with dose or repeated exposure
                                                                      cannot be evaluated from these data.
----------------------------------------------------------------------------------------------------------------

[[Page 15948]]

 
870.7485                                 Metabolism and              Conclusions: Single low (1.5 mg/kg), single
                                          pharmacokinetics            high (300 mg/kg) and repeated low (1.5 mg/
                                          Unacceptable                kg/day for 15 days) oral doses of
                                                                      metolachlor were readily absorbed and
                                                                      eliminated by male and female rats.
                                                                      Urinary and fecal elimination of
                                                                      radioactivity associated with orally
                                                                      administered 14C metolachlor was
                                                                      essentially complete within 48 to 72 hours
                                                                      after dosing. Low- and high-dose females
                                                                      eliminated 14C more rapidly (p<0.003, half-
                                                                      lives of elimination, 16.6 and 15.6 hours,
                                                                      respectively) than low- and high-dose
                                                                      males and repeated-dose animals of both
                                                                      sexes (half-lives, 18.2 and 20.0 hours).
                                                                      Elimination by all animals followed first-
                                                                      order kinetics. Approximately one-half to
                                                                      two-thirds (48 to 64 percent) of the 14C
                                                                      administered was recovered from the urine
                                                                      within 7 days; similar amounts were
                                                                      present in the feces. Low-dose males
                                                                      eliminated slightly more of the
                                                                      radioactive dose in the feces (55 percent)
                                                                      than the urine (48 percent). The opposite
                                                                      trend was seen in the low-dose females and
                                                                      repeated-dose rats of both sexes; these
                                                                      animals excreted approximately 58 to 64
                                                                      percent of the 14C dose in the urine and
                                                                      42.5 to 46.5 percent in the feces within 7
                                                                      days after dosing. High-dose animals
                                                                      excreted similar amounts (58 to 60
                                                                      percent) of the radioactive dose in the
                                                                      urine and feces. Total recoveries of 14C
                                                                      (urine, feces, and tissues) tended to be
                                                                      high and were between 105 and 122.5
                                                                      percent.
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              In a rat metabolism study (MRID 431642-01),14C-Metolachlor was
                                                                      administered orally in PEG-200 HWI 6117-
                                                                      208 or corn oil ABR-94001 to groups (5 sex/
                                                                      dose) of male and female Sprague-Dawley
                                                                      rats at a low oral dose (1.5 mg/kg),
                                                                      repeated low oral dose (1.5 mg/kg x 14
                                                                      days), and a single high dose (300 mg/kg).
                                                                      Control animals (1/sex) received blank
                                                                      formulation.
                                                                      Comparison of oral and intravenous data
                                                                      showed that of the administered dose,
                                                                      between 69.6% and 93.2% was absorbed.
                                                                      Distribution data showed that the only
                                                                      significant sites of residual
                                                                      radioactivity at 7 days post-dose were
                                                                      residual carcass (0.9 - 2.2% of the
                                                                      administered dose) and red blood cells
                                                                      (0.95 - 1.53 [mu]g equivalents/gram in
                                                                      blood cells for all low dose male and
                                                                      female rats). Dosing regimen did not
                                                                      result in any apparent accumulation of
                                                                      residual radioactivity.
                                                                      Excretion data showed that urine and feces
                                                                      were both significant routes for
                                                                      elimination of metolachlor derived
                                                                      radioactivity. In the low dose groups, the
                                                                      urine appeared more of a predominant route
                                                                      for excretion in female rats than in
                                                                      males, whereas fecal excretion was
                                                                      slightly higher in males. However, at the
                                                                      high oral dose, there were no apparent sex-
                                                                      related differences in the pattern of
                                                                      urinary excretion. Examination of urinary
                                                                      excretion data as presented in graphical
                                                                      format indicated that at the 300 mg/kg
                                                                      dose, excretion was delayed vs the low
                                                                      oral dose, suggesting saturation of
                                                                      elimination.
----------------------------------------------------------------------------------------------------------------

    The nature of the toxic effects caused by S-metolachlor are 
discussed in Table 1b below as well as the NOAEL and the LOAEL from the 
toxicity studies reviewed.

Table 1b.--Subchronic, Chronic, and Other Toxicity for S-metolachlor (PC
                              Code 108800)
------------------------------------------------------------------------
          Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.3100                          90-Day oral         NOAEL = 15
                                   toxicity rodents    milligram/
                                                       kilogram/day (mg/
                                                       kg/day)
                                                      LOAEL = 150 mg/kg/
                                                       day based on
                                                       lower body
                                                       weights/body
                                                       weight gains,
                                                       reduced food
                                                       consumption and
                                                       food efficiency
                                                       and increased
                                                       kidney weights in
                                                       males
------------------------------------------------------------------------
870.3100                          90-Day oral         NOAEL = 208 mg/kg/
                                   toxicity rodents    day in males and
                                                       236 mg/kg/day in
                                                       females
                                                      LOAEL was not
                                                       defined.
------------------------------------------------------------------------
870.3150                          90-Day oral         NOAEL = 62 mg/kg/
                                   toxicity in         day in males and
                                   nonrodents          74 mg/kg/day in
                                                       females
                                                      LOAEL = was not
                                                       established
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal NOAEL =
                                   developmental in    50 mg/kg/day
                                   rodents            LOAEL = 500 mg/kg/
                                                       day based on
                                                       increased
                                                       clinical signs of
                                                       toxicity,
                                                       decreased body
                                                       weights/body
                                                       weight gains,
                                                       food consumption
                                                       and food
                                                       efficiency.
                                                      Developmental
                                                       NOAEL = 1,000 mg/
                                                       kg/day
                                                      LOAEL was not
                                                       established
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal NOAEL =
                                   developmental in    20 mg/kg/day
                                   nonrodents         LOAEL =100 mg/kg/
                                                       day based on
                                                       clinical signs of
                                                       toxicity
                                                      Developmental
                                                       NOAEL = 500 mg/kg/
                                                       day
                                                      LOAEL was not
                                                       established
------------------------------------------------------------------------

[[Page 15949]]

 
870.5100                          Gene Mutation Test  There was no
                                                       indication that S-
                                                       metolachlor
                                                       technical induced
                                                       a mutagenic
                                                       effect in any
                                                       tester strain
                                                       either in the
                                                       presence or the
                                                       absence of S9
                                                       activation.
------------------------------------------------------------------------
870.5395                          Cytogenetics        There was no
                                   Micronucleus test   evidence that S-
                                                       metolachlor
                                                       technical induced
                                                       a clastogenic or
                                                       aneugenic effect
                                                       in either sex at
                                                       any dose or
                                                       sacrifice time.
------------------------------------------------------------------------
870.5550                          Other Effects       S-metolachlor
                                   Unscheduled DNA     technical was
                                   synthesis           negative for
                                                       genotoxicity but
                                                       positive for
                                                       cellular
                                                       proliferation
                                                       when tested up to
                                                       overtly toxic and
                                                       cytotoxic doses
                                                       in this in vivo/
                                                       in vitro rat
                                                       hepatocyte RDS/
                                                       UDS assay.
------------------------------------------------------------------------
870.7485                          Metabolism and      S-metolachlor has
                                   pharmacokinetics    a high affinity
                                                       for and a long
                                                       half-life in
                                                       blood (especially
                                                       RBC) which might
                                                       contribute to the
                                                       retarded
                                                       depletion of
                                                       tissue residues.
------------------------------------------------------------------------
870.7485                          Metabolism and      The 72 hour mean
                                   pharmacokinetics    recovery of
                                   Unacceptabler       radioactivity in
                                                       urine, feces, and
                                                       carcass following
                                                       administration of
                                                       0.5 mg/kg of
                                                       Phenyl-U-14C CGA-
                                                       24705 was 43.1%,
                                                       47.0%, and 7.4%
                                                       in males and
                                                       54.0%, 39.4%, and
                                                       4.1% in females,
                                                       respectively. In
                                                       contrast, both
                                                       sexes excreted
                                                       more of the label
                                                       in the feces (M:F
                                                       59.7%:53.4%) than
                                                       in the urine (M:F
                                                       29.4%:39.8%)
                                                       during the same
                                                       period following
                                                       administration of
                                                       the same dose of
                                                       Phenyl-U-14C CGA-
                                                       77102 (the S-
                                                       enantiomer) (MRID
                                                       44491401).
------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where 
the RfD is equal to the NOAEL divided by the appropriate UF (RfD = 
NOAEL/UF). Where an additional safety factor (SF) 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 SF.
    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* 
approachassumes 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. EPA's Health Effects Division's 
Cancer Assessment Review Committee has classified metolachlor as a 
Group C carcinogen with risk quantitated using a non-linear approach. 
The NOAEL of 15 mg/kg/day from the rat combined chronic toxicity/
carcinogenicity study is based on neoplastic nodules/hepatocellular 
carcinomas seen at the highest dose tested of 150 mg/kg/day. The Agency 
notes that the tumor NOAEL of 15 mg/kg/day is comparable to the NOAEL 
of 9.7 mg/kg/day selected for establishing the chronic reference dose 
for metolachlor. It is assumed that the chronic dietary PAD is 
protective for cancer dietary risk. Therefore, a separate cancer 
aggregate risk assessment was not conducted, and cancer DWLOC values 
were not calculated. A summary of the toxicological endpoints for S-
Metolachlor used for human risk assessment is shown in Table 2 of this 
unit:

[[Page 15950]]



    Table 2.--Summary of Toxicological Dose and Endpoints for Metolachlor/S-metolachlor 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 (all population          NOAEL = 300 mg/kg/day    FQPA SF = 1X             Prenatal developmental
 subgroups)                            UF = 100x..............  aPAD = 3.0 mg/kg/day...   toxicity study in rats
                                                                                          with metolachlor-
                                                                                          death, clinical signs
                                                                                          of toxicity (clonic
                                                                                          and/or tonic
                                                                                          convulsions, excessive
                                                                                          salivation, urine-
                                                                                          stained abdominal fur
                                                                                          and/or excessive
                                                                                          salivation) and
                                                                                          decreased body weight
                                                                                          gain
----------------------------------------------------------------------------------------------------------------
Chronic Dietary(All population         NOAEL= 9.7 mg/kg/day     FQPA SF = 1x cPAD = 0.1  Chronic study in dogs
 subgroups)                            UF = 100x..............   mg/kg/day                with metolachlor-
                                                                                          endpoint is decreased
                                                                                          body weight in females
----------------------------------------------------------------------------------------------------------------
Incidental Oral, Short-term (one to    NOAEL = 50               Target MOE = 100         Prenatal developmental
 30 days)                                                                                 toxicity study in rats
                                                                                          with metolachlor-
                                                                                          increased incidence of
                                                                                          clinical signs,
                                                                                          decreased body weight/
                                                                                          body weight gain, food
                                                                                          consumption, and food
                                                                                          efficiency
----------------------------------------------------------------------------------------------------------------
Incidental Oral, Intermediate-term     NOAEL = 8.8              Target MOE = 100         Subchronic (6 month)
 (one month to 180 days)                                                                  toxicity study in dogs
                                                                                          with metolachlor-
                                                                                          decreased body weight
                                                                                          gain
----------------------------------------------------------------------------------------------------------------
Dermal, Short- and Intermediate-Term    No systemic toxicity    None                     Hazard was not
                                        was seen at the limit                             identified for
                                        dose (1,000 mg/kg/day)                            quantification of
                                        following dermal                                  risk.there is no
                                        applications                                      concern for
                                                                                          developmental toxicity
                                                                                          in rats or rabbits.
----------------------------------------------------------------------------------------------------------------
Dermal, Long-Term\a\ (greater than     Oral NOAEL = 9.7         Target MOE = 100         chronic toxicity study
 180 days)                                                                                in dogs with
                                                                                          metolachlor-decreased
                                                                                          body weight gain in
                                                                                          females
----------------------------------------------------------------------------------------------------------------
Inhalation, Short-Term\b\              Oral NOAEL = 50          Target MOE = 100         Prenatal development
                                                                                          toxicity study in rats
                                                                                          with S-metolachlor-
                                                                                          increased incidence of
                                                                                          clinical signs,
                                                                                          decreased body weight/
                                                                                          body weight gain, food
                                                                                          consumption, and food
                                                                                          efficiency
----------------------------------------------------------------------------------------------------------------
Inhalation, Intermediate-Term\b\       Oral NOAEL = 8.8         Target MOE = 100         subchronic (6 month)
                                                                                          toxicity study in dogs
                                                                                          with metolachlor-
                                                                                          decreased body weight
                                                                                          gain
----------------------------------------------------------------------------------------------------------------
Inhalation, Long-Term\b\               Oral NOAEL = 9.7         Target MOE = 100         chronic toxicity study
                                                                                          in dogs with
                                                                                          metolachlor- decreased
                                                                                          body weight gain in
                                                                                          females
----------------------------------------------------------------------------------------------------------------
Cancer                                  Classification: Group C, possible human carcinogen with risk quantitated
                                                              using a non-linear approach.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.
\a\ Since an oral NOAEL was selected, a dermal absorption factor of 58% should be used in route-to-route
  extrapolation.
\b\ Since an oral NOAEL was selected, an inhalation factor of 100% should be used in route-to-route
  extrapolation.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances for 
metolachlor currently cover residues of S-metolachlor on the same 
commodities for the same use pattern when the maximum labeled use rate 
of S-metolachlor is approximately 35 percent less than the historical 
use rate of metolachlor.
    Tolerances have been established (40 CFR 180.368(a)) for the 
combined residues of metolachlor and S-metolachlor in or on a variety 
of raw agricultural commodities. Tolerances for residues of both 
metolachlor and s-metolachlor in or on raw agricultural commodities 
include the combined residues of (free and bound) metolachlor and its 
metabolites, determined as the derivatives, CGA-37913 and CGA-47951, 
each expressed as parent compound. Permanent tolerances for 
metolachlor/S-metolachlor residues have been established on various 
plant commodities ranging from 0.1 ppm in/on numerous commodities to 
30.0 ppm in/on peanut forage and hay (40 CFR 180.368(a)). Time-limited 
tolerances associated with section 18 emergency exemptions have been 
established for metolachlor residues in/on grass forage and hay, 
spinach, and tomato commodities (40 CFR 180.368(b)). Tolerances 
associated with regional registrations have also been established for 
metolachlor residues in/on dry bulb onions, cabbage, and various 
peppers (chili, Cubanelle, and tabasco) (40 CFR 180.368(c)). Risk 
assessments were conducted by EPA to assess dietary exposures from S-
metolachlor in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. The Dietary Exposure Evaluation Model (DEEM[reg]) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the acute 
exposure assessments: A conservative Tier I acute dietary exposure 
assessment was conducted for all labeled metolachlor and S-metolachlor 
food uses. Inputs for this assessment included tolerance-level residue 
values and an assumption that 100% of all labeled crops were treated 
with metolachlor/S-metolachlor. For all supported registered 
commodities, the acute dietary exposure estimates are

[[Page 15951]]

below the Agency's level of concern (<100% aPAD) at the 95th exposure 
percentile for the general U.S. population and all population 
subgroups. The acute dietary risk estimate for the highest exposed 
population subgroup, children 1-6 years of age, is <1% of the aPAD. 
Acute dietary risk estimates are not of concern. Results of the acute 
dietary risk assessment are presented in Table 3 below.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM[reg]) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1989-1992 nationwide CSFII and accumulated exposure to the 
chemical for each commodity. The following assumptions were made for 
the chronic exposure assessments: A conservative Tier I chronic dietary 
exposure assessment was conducted for all supported metolachlor and S-
metolachlor food uses. For all supported registered commodities, the 
chronic dietary exposure estimates are below the Agency's level of 
concern (<100% cPAD) for the general U.S. population and all population 
subgroups. The chronic dietary risk estimate for the highest exposed 
population subgroup, children 1-6 years of age, is 4% of the cPAD. 
Chronic dietary risk estimates are not of concern. Results of the 
chronic dietary risk assessment are presented in Table 3 below.

                Table 3.--Summary of Dietary Exposure Estimates for Metolachlor and S-metolachlor
----------------------------------------------------------------------------------------------------------------
                                                  Acute Dietary               Chronic Dietary
                                          ----------------------------------------------------------
           Population Subgroup                 Dietary                      Dietary                  Cancer Risk
                                            Exposure (mg/     % aPAD     Exposure (mg/     % cPAD
                                               kg/day)                      kg/day)
----------------------------------------------------------------------------------------------------------------
General U.S. Population                          0.004111           <1        0.001643            2           NA
-----------------------------------------------------------------------------------------------------
All Infants (<1 year old)                        0.006855           <1        0.002280            2          N/A
-----------------------------------------------------------------------------------------------------
Children 1-2 years old                           0.008224           <1        0.004025            4           NA
-----------------------------------------------------------------------------------------------------
Children 3-5 years old                           0.006965           <1        0.003510            4           NA
-----------------------------------------------------------------------------------------------------
Children 6-12 years old                          0.005003           <1        0.002412            2           NA
-----------------------------------------------------------------------------------------------------
Youth 13-19 years old                            0.003309           <1        0.001515            2           NA
-----------------------------------------------------------------------------------------------------
Adults 20-49 years old                           0.002815           <1        0.001263            1           NA
-----------------------------------------------------------------------------------------------------
Females 13-49 years old                          0.002965           <1        0.001349            1           NA
-----------------------------------------------------------------------------------------------------
Adults 50+ years old                             0.002839           <1        0.001226            1           NA
----------------------------------------------------------------------------------------------------------------
NA = not applicable

    The Agency notes that the conservative Tier I dietary assessments 
for metolachlor and S-metolachlor could be refined for more realistic 
dietary exposure estimates by using available percent crop treated 
estimates, field trial and monitoring data, and processing factors; 
however, the estimated dietary risk to metolachlor and S-metolachlor is 
not of concern for all populations in both the acute and chronic 
assessments. Further refinements are not warranted at this time.
    2. Dietary exposure from drinking water. A drinking water 
assessment for metolachlor and S-metolachlor involved the analysis of 
surface and ground water monitoring data, prospective ground water 
study data, and Tier I (FIRST and screening concentration in ground 
water (SCI-GROW)) and Tier II (pesticide root zone modeling/exposure 
analysis modeling system (PRZM/EXAMS)) modeling results. This 
assessment includes concentrations of parent metolachlor/S-metolachlor 
and the degradates metolachlor ethanesulfonic acid (ESA) and 
metolachlor oxanilic acid (OA). Although it was determined by the 
Metabolism Assessment Review Committee that the ESA and OA metabolites 
appear to be less toxic than parent metolachlor/S-metolachlor, they are 
included in this risk assessment since they were found in greater 
abundance than the parent in water monitoring studies.
    The Agency notes that a key assumption of the drinking water 
assessment is that reported monitoring data represent both racemic 
metolachlor and S-metolachlor. The analytical methods for surface and 
ground water monitoring data used in this assessment were unable to 
distinguish between metolachlor and S-metolachlor at the time 
monitoring was conducted. However, the Agency believes that the fate 
properties of racemic metolachlor and S-metolachlor are similar. 
Therefore, the EECs used in this risk assessment are representative of 
both racemic metolachlor and S-metolachlor.
    The environmental fate data base is complete for metolachlor. 
Parent metolachlor/S-metolachlor appear to be moderately persistent to 
persistent, and range from mobile to highly mobile in different soils. 
Metolachlor/S-metolachlor have reportedly been detected as deep as the 
36 to 48 inch soil layer (maximum sampled soil depth) in some studies. 
Degradation appears to be dependent on microbially mediated and abiotic 
processes. The frequency of detection of metolachlor/S-metolachlor from 
evaluated monitoring data suggest that contamination in drinking water 
sources may be widespread.
    Environmental fate data comparing metolachlor and S-metolachlor 
indicate that both are expected to have similar degradation pathways 
and rates in soil and water environments, and both are expected to be 
mobile to highly mobile in soil and water environments.
    i. EECs for parent metolachlor/S-metolachlor. No single surface or 
ground water monitoring study that was representative of the entire 
metolachlor/S-metolachlor use area was available for the drinking water 
assessment. As a result, the drinking water assessment for parent 
metolachlor/S-metolachlor is based primarily on monitoring data

[[Page 15952]]

from the following sources: the U.S. Geological Survey (USGS) National 
Water Quality Assessment (NAWQA) database, the US EPA STORET data base, 
the Acetochlor Registration Partnership (ARP) data base, and two USGS 
Reservoir Monitoring studies.
    The acute estimated environmental concentration (EEC) of 77.6 parts 
per billion (ppb) was selected from the NAWQA database, and the chronic 
EEC of 4.3 ppb was selected from the maximum annual time weighted mean 
from the NAWQA data. These values are representative of the estimated 
concentration of parent metolachlor/S-metolachlor in monitored ambient 
surface water, and are supported by the metolachlor concentrations from 
the National Contaminant Occurrence Database representing analysis of 
treated drinking water, as well as from model predictions using PRZM/
EXAMS.
    Acute and chronic concentrations of parent metolachlor/S-
metolachlor in ground water were modeled using SCI-GROW. SCI-GROW 
estimates the high-end ground water concentrations of pesticides likely 
to occur when the pesticide is used at the maximum allowable rate in 
areas with ground water vulnerable to contamination. Estimates were 
based on two applications to corn/turf for a total of 4 lbs ai/acre 
(the maximum application rate). In comparison to the SCI-GROW estimate 
of 5.5 ppb in shallow ground water, the Iowa NAWQA data have a maximum 
concentration of 15.4 ppb. However, it should be noted that the second 
highest concentration of parent metolachlor/S-metolachlor in the Iowa 
NAWQA data is 1.7 ppb. Since the detections in the National NAWQA data 
(32.8 ppb) and in the Iowa NAWQA data (15.4 ppb) were single values 
outside the range of the rest of the data, EPA determined that use of 
SCI-GROW was more appropriate for the risk assessment.
    Additionally, recent data collected by the Suffolk County, New York 
Department of Health Services, Bureau of Groundwater Resources indicate 
that both metolachlor and S-metolachlor, and its degradates, have been 
detected in ground water. In data collected between 1997 and 2001, 
metolachlor/S-metolachlor was detected in 60 well samples with a 
maximum concentration of 83 ppb. No information was available on 
frequency of detection and only summary statistics were provided on 
these data; therefore, these data were not used quantitatively in the 
risk assessment. However, these data suggest that the SCI-GROW 
estimates for metolachlor/S-metolachlor are not overestimating the 
potential impact of metolachlor/S-metolachlor use on ground water. The 
SCI-GROW estimate of 5.5 ppb in ground water is appropriate for risk 
assessment purposes.
    ii. EECs for metolachlor ESA and OA degradates. Only two small data 
sets were available on the ESA and OA degradates from the Iowa and 
Illinois NAWQA data. In the absence of more robust monitoring data for 
the degradates, upper-bound Tier I estimates for ESA and OA based on 
FIRST and SCI-GROW modeling were used to calculate EECs for the 
degradates. The modeling used conservative assumptions of selected fate 
parameters (aerobic soil metabolism rate constant and soil partitioning 
coefficient) as well as the maximum application rate of 4 lbs ai/acre 
on turf/corn.
    Acute and chronic estimates of metolachlor ESA in surface water 
(based on FIRST modeling) are 31.9 ppb and 22.8 ppb, respectively. 
Acute and chronic estimates of metolachlor OA in surface water are 91.4 
ppb and 65.1 ppb, respectively. The Agency notes that the application 
rate used for metolachlor ESA and OA in the model runs was estimated by 
converting maximum label rates for each use by the maximum percentage 
of degradate found in fate studies. In addition, each application rate 
was corrected for molecular weight differences of each degradate. 
However, a statistically significant relationship between parent 
metolachlor and degradates could not be established; therefore, the 
amount of degradate is an uncertainty in this assessment. This 
uncertainty was addressed in the screening level assessments using 
FIRST and SCI-GROW with conservative assumptions for model inputs. The 
model predictions for ESA and OA compare with the limited monitoring 
data available. The screening level predictions were higher than the 
available data suggesting that the predictions were likely upper bound 
and conservative. EPA determined that these upper bound predictions 
will not underestimate the potential exposures for infants and children 
from the use of metolachlor.
    Acute and chronic estimates of metolachlor ESA in ground water 
(based on SCI-GROW modeling, turf/corn scenario) are not expected to 
exceed 65.8 ppb. This value is considered representative of both peak 
and long-term average concentrations because of the inherent transport 
nature of ground water (generally slow movement from the source of 
contamination both laterally and horizontally). Acute and chronic 
estimates of metolachlor OA in ground water (also based on the turf /
corn scenario) are not expected to exceed 31.7 ppb. The Agency notes 
that these values exceed those detected in the Iowa NAWQA study (63.7 
ppb for metolachlor ESA and 4.4 ppb for metolachlor OA), and also 
exceed those values detected in two PGW studies (metolachlor ESA was 
detected at a maximum concentration of 24 ppb while metolachlor OA was 
detected at a maximum concentration of 15.6 ppb). In addition, recent 
data collected by the Suffolk County, New York Department of Health 
Services, Bureau of Groundwater Resources indicate that both 
metolachlor and S-metolachlor, and its degradates, have been detected 
in ground water. In data collected between 1997 and 2001, metolachlor 
ESA was detected in 296 well samples with a maximum concentration of 
39.7 ppb, while metolachlor OA was detected in 228 wells with a maximum 
concentration of 49.6 ppb. No information was available on frequency of 
detection and only summary statistics were provided on these data; 
therefore, these data were not used quantitatively in the risk 
assessment.
    iii. Drinking water levels of comparison (DWLOCs). In the absence 
of chemical-specific monitoring data, the Agency uses drinking water 
levels of comparison to calculate aggregate risk. A drinking water 
level of comparison, or a DWLOC, is a theoretical upper limit on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, drinking water, and through 
residential uses. In other words, the DWLOC value represents the 
maximum theoretical exposure a person may have to pesticide residues 
through drinking water, after their exposure to the pesticide's 
residues through food and residential exposure have been taken into 
consideration. The Office of Pesticide Programs uses DWLOCs internally 
in the risk assessment process as a surrogate measure of potential 
exposure associated with pesticide exposure through drinking water. 
DWLOC values are not regulatory standards for drinking water; however, 
they do have an indirect regulatory impact through aggregate exposure 
and risk assessments.
    DWLOCs are calculated for each type of risk assessment as 
appropriate (acute, short-term, intermediate-term, chronic, and cancer) 
and compared to the appropriate estimated concentration of a pesticide 
in surface and ground water. If the DWLOC is greater than the estimated 
surface and ground water concentration, (i.e., if the DWLOC > EEC), the 
Agency concludes with

[[Page 15953]]

reasonable certainty there is no drinking water risk of concern.
    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). S-Metolachlor is 
currently registered for use on the following residential non-dietary 
sites: lawn, turf (including sod farms), golf courses, sports fields, 
and ornamental gardens. Although not labeled as a restricted-use 
pesticide, the label indicates that it is not intended for use by 
homeowners but only for use by professional lawn care applicators. On 
this basis, a residential handler is not expected to be exposed to 
residues of S-metolachlor. Therefore, a residential handler assessment 
was not conducted.
    There is potential for postapplication exposure to adults and 
children resulting from the use of S-metolachlor on residential lawns. 
Although the use sites for S-metolachlor vary from golf courses to 
ornamental gardens, the residential lawn scenario represents what the 
Agency considers the likely upper-end of possible exposure. 
Postapplication exposures from various activities following lawn 
treatment are considered to be the most common and significant in 
residential settings.
    Postapplication exposure is considered to be short-term (1 to 30 
days of exposure) only, based on a label specification of a 6-week 
interval before the re-application of S-metolachlor.
    A short-term dermal endpoint was not selected, since no systemic 
toxicity was seen at the limit dose of 1,000 mg/kg/day; therefore, a 
dermal risk assessment was not conducted and dermal exposures are 
assumed to be minimal. Postapplication inhalation exposure is also 
expected to be minimal since S-metolachlor is only applied in an 
outdoor setting, the vapor pressure is low (2.8 x 
10-5 mm Hg at 25 [deg]C), and the label specifies 
that residents should not re-enter treated areas until after sprays 
have dried.
    The following postapplication incidental oral scenarios following 
application to lawns and turf have been identified: (1) Short-term oral 
exposure to toddlers and children following hand-to-mouth exposure; (2) 
short-term oral exposure to toddlers and children following object-to-
mouth exposure; and (3) short-term oral exposure to toddlers and 
children following soil ingestion. The term ``incidental'' is used to 
distinguish the inadvertent oral exposure of small children from 
exposure that may be expected from treated foods or residues in 
drinking water.
    Since the FQPA safety factor for the protection of children and 
infants was reduced to 1X, a target MOE value of 100 has been 
identified for residential assessments. MOE values greater than 100 are 
not considered to be of concern to the Agency. MOE estimates are based 
on the dose level of 50 mg/kg/day established for short-term oral risk 
assessment.
    The exposure and risk estimates for the three residential exposure 
scenarios are assessed for the day of application (day ``0'') since 
children will likely contact the lawn immediately following 
application.
    The following estimates/assumptions were used in the risk 
assessment: (1) A single application at the maximum label rate of 2.47 
lb ai/acre for S-metolachlor, (2) exposure duration for children is 
assumed to be 2 hours per day, (3) the exposed child's weight is 15 kg 
(33 pounds), and (4) turf transferable residue (TTR) value of 5%, and 
object-to-mouth residue value of 20% of the application rate assumed.
    The exposure estimates for the three postapplication scenarios 
(object-to-mouth, hand-to-mouth, and incidental soil ingestion) were 
combined to represent the possible (if not likely) high-end oral 
exposure resulting from lawn (or similar use). Combined post-
application oral risk estimates for S-metolachlor are not of concern. 
The following Table 4 summarizes the results of the residential 
postapplication assessment:

                                               Table 4.--Summary of Residential Postapplication MOE Values
--------------------------------------------------------------------------------------------------------------------------------------------------------
           Exposure Scenario\a\                  S-Metolachlor\b\                Oral Dose (mg/kg/day)                    Oral Short-term MOE\c\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Object-to-mouth                            S-metolachlor                                                 0.0092                                    5,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hand-to-mouth                              S-metolachlor                                                  0.037                                    1,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Soil ingestion                             S-metolachlor                                                0.00012                                  400,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combined exposure                          S-metolachlor                                                  0.046                                    1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Exposure scenario represents oral exposure of children, with an assumed body weight of 15 kg.
\b\ S-metolachlor application rate is 2.47 lb ai/acre.
\c\ Short-term oral MOE = NOAEL/Dose, where short-term oral NOAEL = 50 mg/kg/day.

    S-metolachlor may be used on sports and recreational fields, as 
well as golf courses. However, the Agency believes that children's 
exposure to residues of S-metolachlor remaining on residential lawns 
after treatment represents the likely upper-end of exposure. 
Furthermore, since dermal and inhalation risks are not of concern, and 
oral exposures from sports and recreational fields, as well as golf 
courses, are expected to be minimal, risks for these other non-
occupational settings are expected to be insignificant.
    The Agency has conducted a direct exposure assessment for the use 
of S-metolachlor on lawns, and determined that there is no risk of 
concern from this use. No additional risk from S-metolachlor is 
expected from spray drift.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA 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.''
    The chloroacetanilide pesticides represent a class of food use 
pesticides that have been given high priority by the Agency for the 
reassessment of tolerances in accordance with the mandates of FQPA. The 
group of chloroacetanilide pesticides covered by this review consists 
of acetochlor, alachlor, butachlor, metolachlor and propachlor. Various 
members of this group of chloroacetanilide pesticides have been shown 
to result in several different types of tumor responses in laboratory 
animals (e.g., nasal, thyroid, liver, and stomach tumors). Therefore, 
as part of the reassessment, EPA

[[Page 15954]]

scientists considered several different potential common mechanism of 
toxicity groupings for these chemicals.
    In reviewing this issue, EPA scientists were guided by several 
relevant Agency science policies, including Guidance for Identifying 
Pesticide Chemicals and Other Substances that Have a Common Mechanism 
of Toxicity. Additionally, on March 19, 1997, the Agency presented to 
the FIFRA Scientific Advisory Panel (SAP) a draft case study 
illustrating the application of the Common Mechanism Guidance to the 
grouping of chloroacetanilide pesticides based on a common mechanism of 
toxicity. The SAP agreed with the Agency's conclusion that there is 
sufficient evidence to support the grouping of certain 
chloroacetanilides that cause nasal turbinate tumors by a common 
mechanism of toxicity.
    Upon consideration of the SAP comments, EPA's own reviews and the 
data underlying these reviews, as well as additional information 
received by the Agency from registrants or presented in the open 
literature since the 1997 draft document, EPA has revised its science 
document discussing the potential grouping of chloroacetanilide 
pesticides, or a subgroup of them, based on a common mechanism of 
toxicity.
    In the revised document entitled ``The Grouping of a Series of 
Chloroacetanilide Pesticides Based on a Common Mechanism of Toxicity,'' 
EPA has concluded that only some of the pesticides that comprise the 
class of chloroacetanilides should be designated as a ``Common 
Mechanism Group'' based on the development of nasal turbinate tumors by 
metabolism to a highly, tissue reactive moiety, i.e., quinoneimine. 
Thus, only acetochlor, alachlor, and butachlor should be grouped based 
on a common mechanism of toxicity for nasal turbinate tumors. Although 
metolachlor does distribute to the nasal turbinates, and might produce 
a quinoneimine, it is not apparent from currently available data that 
it shares the same target site in the nasal tissue as acetochlor, 
alachlor and butachlor. Although propachlor does produce a precursor of 
a quinoneimine, the available data do not support its tumorigenicity to 
the nasal turbinates.
    In conclusion, it is the Agency's position, that only some 
chloroacetanilides, namely acetochlor, alachlor, and butachlor should 
be considered as a ``Common Mechanism Group'' due to their ability to 
cause nasal turbinate tumors. For purposes of a cumulative risk 
assessment as a part of the tolerance reassessment process for 
acetochlor, alachlor, and butachlor, these three pesticides will be 
considered as a Common Mechanism Group. Following the initiation of a 
cumulative risk assessment, further analyses of new or existing data 
may occur which could impact the Agency's evaluation of specific 
members of this group or the group as a whole.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA 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. Prenatal developmental 
studies in the rat and rabbit revealed no evidence of a qualitative or 
quantitative susceptibility in fetal animals.
    3. Conclusion. There is a complete toxicity data base for S-
metolchlor and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X SF to protect infants and children should be removed. The 
FQPA Safety Factor Committee met on November 5, 2001 to evaluate the 
hazard and exposure data for metolachlor and S-metolachlor, and 
recommended that the FQPA Safety Factor for the protection of infants 
and children be reduced to 1x for the following reasons: (1) The 
toxicology database is complete for the FQPA assessment; (2) there is 
no indication of quantitative or qualitative increased susceptibility 
of rats or rabbits to in utero and/or postnatal exposure to metolachlor 
in the available toxicity data; (3) a developmental neurotoxicity study 
is not required for metolachlor; and (4) the dietary (food and drinking 
water) and non-dietary exposure (residential) assessments will not 
underestimate the potential exposures for infants and children from the 
use of metolachlor.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. An acute aggregate risk assessment addresses 
potential exposure from combined residues of metolachlor/S-metolachlor 
on food and in drinking water (both surface and ground water). 
Potential residential exposures are not incorporated into an acute 
aggregate risk assessment. As shown in Table 5 below, the EECs are 
below the Agency's back-calculated DWLOC values for the parent 
compound, the ESA degradate, and the OA degradate. The combined value 
of the parent plus the degradates is also below the acute DWLOC value. 
The Agency concludes that acute aggregate risk estimates are not of 
concern for any population subgroup.

                        Table 5.--Acute DWLOC Calculations for Metolachlor/S-Metolachlor
----------------------------------------------------------------------------------------------------------------
                                                                 Surface       Ground
        Population Subgroup           aPAD (mg/      % aPAD     Water EEC    Water EEC      Acute DWLOC (ppb)
                                         kg)         (Food)       (ppb)*       (ppb)*
----------------------------------------------------------------------------------------------------------------
U.S. Population                              3.0            1        200.9          103                1.0 x 105
----------------------------------------------------------------------------
Females 13-50                                3.0            1        200.9          103                9.0 x 104
----------------------------------------------------------------------------
Children 1-6                                 3.0            1        200.9          103                3.0 x 104
----------------------------------------------------------------------------
Males 13-19                                  3.0            1        200.9          103                9.0 x 104
----------------------------------------------------------------------------------------------------------------
* Represents the combined value of parent plus the ESA and OA degradates.

    2. Chronic risk. A chronic aggregate risk assessment considers 
chronic exposure from food, drinking water, and non-occupational 
(residential) pathways of exposure. For metolachlor and S-metolachlor, 
there are no chronic

[[Page 15955]]

(greater than 180 days of exposure) non-occupational exposure 
scenarios. Therefore, the chronic aggregate risk assessment will 
consider exposure from food and drinking water only. The EECs for 
ground water residues of the parent compound (5.5), the ESA degradate 
(65.8), and the OA degradate (31.7) are below the Agency's chronic 
DWLOC values for all population subgroups. The combined value of the 
parent plus degradates (103) is also below the chronic DWLOC value. The 
EECs for surface water residues of the parent compound (4.3), the ESA 
degradate (22.8), and the OA degradate (65.1) are below the Agency's 
chronic DWLOC values for all population subgroups. The combined value 
of the parent plus degradates (92.2) is also below the chronic DWLOC 
value. The Agency concludes that chronic aggregate risks are not of 
concern.

       Table 6.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to metolachlor/S-metolachlor
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)*       (ppb)*    DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                          0.1            2         92.2          103      3442.50
----------------------------------------------------------------------------------------------------------------
Females 13-50                                            0.1            1         92.2          103      2962.11
----------------------------------------------------------------------------------------------------------------
Children 1-6                                             0.1            4         92.2          103       959.75
----------------------------------------------------------------------------------------------------------------
Males 13-19                                              0.1            2         92.2          103      2954.55
----------------------------------------------------------------------------------------------------------------
* Represents the combined value of parent plus the ESA and OA degradates.

    3. Short-term risk. A short-term aggregate risk assessment 
considers potential exposure from food, drinking water, and short-term, 
non-occupational (residential) pathways of exposure. For S-metolachlor, 
potential short-term, non-occupational risk scenarios include oral 
exposure of children to treated lawns. In this aggregate short-term 
risk assessment, exposure from food, drinking water, and residential 
lawns (S-metolachlor use only) has been considered. Since only children 
have the potential for non-occupational, short-term risk, they are the 
only population subgroup included below. Short-term DWLOC values have 
been calculated for S-metolachlor only, since Syngenta no longer holds 
any racemic metolachlor residential end-use products. EECs for the 
parent compound, the ESA degradate, and the OA degradate are below the 
short-term S-metolachlor DWLOC value for the population children (1 to 
6 years old). The combined value of the parent plus the degradates is 
also below the short-term S-metolachlor DWLOC value. The Agency 
concludes that short-term aggregate risks from S-metolachlor are not of 
concern. The target MOE is 100, based on the 100x uncertainty factor, 
and the 1x FQPA safety factor. This MOE is not exceeded by the MOE for 
food which is 1.6 X 104 (short-term oral NOAEL (50 mg/kg/
day)/chronic dietary exposure of children (0.003171 mg/kg/day); MOE for 
oral which is 1,100 (short-term oral NOAEL (50 mg/kg/day)/combined 
hand-to-mouth, object-to-mouth, and soil ingestion oral exposure (0.046 
mg/kg/day S-metolachlor)); aggregate MOE for food and residential which 
is 1,000 (1 / (1 / MOE food) + (1 / MOE oral)); or allowable water 
exposure which is 0.45 mg/kg/day (1 / (1 / Target Aggregate MOE) - (1 / 
Aggregate MOE (food and residential)). The DWLOC is 4,000 ppb. The EEC 
for ground water is 103.3 ppb (parent 5.5, ESA metabolite 65.8 ppb and 
OA metabolite 32 ppb). The EEC for surface water is 92.2 ppb (parent 
4.3, ESA metabolite 22.8 ppb and OA metabolite 65.1 ppb).
    For informational purposes, it is noted that the EEC values for the 
parent compound, ESA degradate, and the OA degradate are below the 
metolachlor short-term DWLOC value for children. The combined value of 
the parent plus the degradates is also below the metolachlor short-term 
DWLOC value.

            Table 7.--Aggregate Risk Assessment for Short-Term Exposure to Metolachlor/S-metolachlor
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Children 1 to 6                                        1,000          100         92.2        103.3        4,000
----------------------------------------------------------------------------------------------------------------

    4. Intermediate-term risk. An intermediate-term aggregate risk 
assessment considers potential exposure from food, drinking water, and 
non-occupational (residential) pathways of exposure. However, for 
metolachlor/S-metolachlor, no intermediate-term non-occupational 
exposure scenarios (greater than 30 days exposure) are expected to 
occur. Therefore, intermediate-term DWLOC values were not calculated 
and an intermediate-term aggregate risk assessment is not required.
    5. Aggregate cancer risk for U.S. population. An aggregate cancer 
risk assessment considers potential carcinogenic exposure from food, 
drinking water, and non-occupational (residential) pathways of 
exposure. However, as noted under Unit III.B., Toxicological Endpoints, 
the NOAEL that was established based on tumors in the rat (15 mg/kg/
day, seen at the highest dose tested of 150 mg/kg/day) is comparable to 
the NOAEL of 9.7 mg/kg/day selected for establishing the chronic 
reference dose for metolachlor. It is assumed that the chronic dietary 
endpoint is protective for cancer dietary exposure. Therefore, a 
separate cancer aggregate risk assessment was not conducted, and cancer 
DWLOC values were not calculated.
    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

[[Page 15956]]

from aggregate exposure to metolachlor/S-metolachlor residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The Pesticide Analytical Manual (PAM) Vol. II, lists a gas 
chromatography/nitrogen phosphorous detection (GC/NPD) method (Method 
I) for determining residues in/on plants and a gas chromatography/mass 
spectrometry detection (MSD) method (Method II) for determining 
residues in livestock commodities. These methods determine residues of 
metolachlor and its metabolites as either CGA-37913 or CGA-49751 
following acid hydrolysis. Residue data from the most recent field 
trials and processing studies were obtained using an adequate GC/NPD 
method (AG-612), which is a modification of Method I. Adequate data are 
available on the recovery of metolachlor through Multi-residue Method 
Testing Protocols. The FDA PESTDATA database indicates that metolachlor 
is completely recovered through Method 302, PAM Vol. I (3rd ed., 
revised 10/97).

B. International Residue Limits

    No maximum residue limits (MRLs) for either metolachlor or S-
metolachlor have been established or proposed by Codex, Canada, or 
Mexico for any agricultural commodity; therefore, no compatibility 
questions exist with respect to U. S. tolerances.

C. Conditions

    The need for a 28-day inhalation study has been identified for both 
metolachlor and S-metolachlor. Submission of this study would allow the 
Agency to improve characterization regarding the concern for toxicity 
via the inhalation route of exposure following application of 
metolachlor/S-metolachlor on multiple days in a commercial setting.

V. Conclusion

    Therefore, the tolerance is established for combined residues or 
residues of S-metolachlor Acetamid, 2-chloro-N-(2-ethyl-6-
methylphenyl)-N-(2-methoxy-1-methylethyl)-, (S) and its metabolites, 
determined as the derivatives, 2-(2-ethyl-6-methylphenyl)amino-1-
propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-
morpholinone, each expressed as the parent compound S-metolachlor in or 
on the raw agricultural commodities each expressed as the parent 
compound in or on the raw agricultural commodities grass forage at 10.0 
ppm, grass hay at 0.02 ppm, spinach at 0.5 ppm, sugar beet at 0.5 ppm, 
sugar beet molasses at 3.0 ppm, sugar beet tops at 15.0 ppm, sunflower 
at 0.5 ppm, sunflower meal at 1.0 ppm, and tomato at 0.1 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA 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) 
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 
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-2003-0046 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 June 2, 
2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    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 20460-0001.
    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.1. Mail your 
copies, identified by docket ID number OPP-2003-0046, 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-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. 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.

[[Page 15957]]

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 and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA 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 section 408(d) of the FFDCA, 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 section 408(n)(4) of the FFDCA. 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. Congressional Review Act

    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: March 25, 2003.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

0
2. Section 180.368 is amended in paragraph (a) by designating the text 
following the paragraph heading ``General,'' as paragraph (a)(1) and by 
adding new paragraph (a)(2) to read as follows:


Sec.  180.368  Metholachlor; tolerances for residues.

    (a) General. (1) * * *
    (2) Tolerances are established for combined residues of the 
herbicide S-metolachlor acetamid, 2-chloro-N-(2-ethyl-6-methylphenyl)-
N-(2-methoxy-1-methylethyl)-, (S) and its metabolites, determined as 
the derivatives, 2-(2-ethyl-6-methylphenyl)amino-1-propanol and 4-(2-
ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, each expressed 
as the parent compound S-metolachlor in or on the following raw 
agricultural commodities:

[[Page 15958]]



------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Beet, sugar, molasses......................................          2.0
Beet, sugar, roots.........................................          0.5
Beet, sugar, tops..........................................         15.0
Grass, forage..............................................         10.0
Grass, hay.................................................          0.2
Spinach....................................................          0.5
Sunflower, seed............................................          0.5
Sunflower, meal............................................          1.0
Tomato.....................................................          0.1
------------------------------------------------------------------------

* * * * *
[FR Doc. 03-7800 Filed 4-1-03; 8:45 am]
BILLING CODE 6560-50-S