[Federal Register Volume 68, Number 2 (Friday, January 3, 2003)]
[Rules and Regulations]
[Pages 274-283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5]



[[Page 274]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0331; FRL-7283-2]


S-metolachlor; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for the 
combined residues (free and bound) of the herbicide s-metolachlor [(S)-
2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide], its R-enantiomer 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 sweet 
potatoes. This action is in response to EPA's granting of an emergency 
exemption under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) authorizing use of the pesticide on sweet 
potatoes. This regulation establishes a maximum permissible level for 
residues of s-metolachlor in this food commodity. The tolerance will 
expire and is revoked on December 31, 2004. Although the exemption was 
granted for the active ingredient s-metolachlor and the time-limited 
tolerance is being set for s-metolachlor, the Agency has determined 
that residues of concern for s-metolachlor are the same as those for 
metolachlor, and therefore, the tolerance is being included under 40 
CFR 180.368 but under its own section in paragraph (b). Metabolites of 
metolachlor are assumed to be toxicologically equivalent to parent 
metolachlor. The Agency has determined that the residues of concern for 
plant and animal commodities are metolachlor and its metabolites, 
determined as the derivatives CGA-37913 and CGA-49751.

DATES: This regulation is effective January 3, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0331, 
must be received on or before March 4, 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 VII. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman,Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number:(703)308-9367; 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 a federal 
or state government agency involved in administration of environmental 
quality programs (i.e., Departments of Agriculture, Environment, etc). 
Potentially affected entities may include, but are not limited to:
    [sbull] Federal or State Government Entity, (NAICS 9241), 
Departments of Agriculture, Environment, etc.
    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-2002-0331. 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.
    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

    EPA, on its own initiative, in accordance with sections 408(e) and 
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing a tolerance for the combined residues 
(free and bound) of the herbicide s-metolachlor [(S)-2-chloro-N-(2-
ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide], its R-
enantiomer 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 sweet potatoes at 0.2 parts per million (ppm). This 
tolerance will expire and is revoked on December 31, 2004. EPA will 
publish a document in the Federal Register to remove the revoked 
tolerance from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 of the FFDCA and the new safety standard to 
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.

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    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 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. . . 
.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for S-metolachlor on Sweet Potatoes and FFDCA 
Tolerances

    The States of Louisiana and Mississippi requested the use of s-
metolachlor on sweet potatoes to control sedges due to an increased 
pressure from these weed species and a lack of effective registered 
alternatives. EPA has authorized under FIFRA section 18 the use of s-
metolachlor on sweet potatoes for control of sedges in Louisiana and 
Mississippi. After having reviewed the submission, EPA concurs that 
emergency conditions exist for these States.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of s-metolachlor in or on 
sweet potatoes. In doing so, EPA considered the safety standard in 
section 408(b)(2) of the FFDCA, and EPA decided that the necessary 
tolerance under section 408(l)(6) of the FFDCA would be consistent with 
the safety standard and with FIFRA section 18. Consistent with the need 
to move quickly on the emergency exemption in order to address an 
urgent non-routine situation and to ensure that the resulting food is 
safe and lawful, EPA is issuing this tolerance without notice and 
opportunity for public comment as provided in section 408(l)(6) of the 
FFDCA. Although this tolerance will expire and is revoked on December 
31, 2004, under section 408(l)(5) of the FFDCA, residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on sweet potatoes after that date will not be unlawful, 
provided the pesticide is applied in a manner that was lawful under 
FIFRA, and the residues do not exceed a level that was authorized by 
this tolerance at the time of that application. EPA will take action to 
revoke this tolerance earlier if any experience with, scientific data 
on, or other relevant information on this pesticide indicate that the 
residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether s-metolachlor 
meets EPA's registration requirements for use on sweet potatoes or 
whether a permanent tolerance for this use would be appropriate. Under 
these circumstances, EPA does not believe that this tolerance serves as 
a basis for registration of s-metolachlor by a State for special local 
needs under FIFRA section 24(c). Nor does this tolerance serve as the 
basis for any State other than Louisiana and Mississippi to use this 
pesticide on this crop under section 18 of FIFRA without following all 
provisions of EPA's regulations implementing FIFRA section 18 as 
identified in 40 CFR part 166. For additional information regarding the 
emergency exemption for s-metolachlor, contact the Agency's 
Registration Division at the address provided under FOR FURTHER 
INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    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) .
    The Agency has determined that the residues of concern for plant 
and animal commodities are metolachlor and its metabolites, determined 
as the derivatives CGA-37913 and CGA-49751. Metabolites of metolachlor 
are assumed to be toxicologically equivalent to parent metolachlor. The 
residues of concern for s-metolachlor are the same as those for 
metolachlor.
    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 s-
metolachlor and to make a determination on aggregate exposure, 
consistent with section 408(b)(2) of the FFDCA, for a time-limited 
tolerance for the combined residues (free and bound) of the herbicide 
s-metolachlor [(S)-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide], its R-enantiomer 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 sweet 
potatoes at 0.2 ppm.
    EPA's assessment of the dietary exposures and risks associated with 
establishing the tolerance follows.

A. 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 endpoint. However, the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved 
in the toxicology study selected. An uncertainty factor (UF) is applied 
to reflect uncertainties inherent in the extrapolation from laboratory 
animal data to humans and in the variations in sensitivity among 
members of the human population as well as other unknowns. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (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

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to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated 
and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x10-\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 (MOE cancer = point of 
departure/exposures) is calculated.
    S-metolachlor, [2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide], is a member of the chloroacetanilide class of 
herbicides. In this risk assessment the term s-metolachlor will refer 
to a metolachlor product which is enriched in the S-isomer. The term 
metolachlor will refer to a racemic mixture of the R and S isomers.
    Toxicological endpoints have been selected for metolachlor and s-
metolachlor for use in human health risk assessments. The Agency has 
determined that metolachlor and s-metolachlor are of comparable 
toxicity, and therefore, studies with both chemicals were used 
interchangeably for toxicology endpoint selection.
    A summary of the toxicological endpoints for s-metolachlor used for 
human risk assessment is shown in the following Table 1:

    Table 1.--Summary of Toxicological Dose and Endpoints for S-Metolachlor for Use in Human Risk Assessment
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                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
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Acute Dietary (Females 13-50 years of  NOAEL = 300 mg/kg/day    FQPA SF = 1x             Prenatal developmental
 age)                                  UF = 100...............  aPAD = acute RfD/FQPA     toxicity study in rats
                                       Acute RfD = 3.0 mg/kg/    SF.                     LOAEL = 1,000 mg/kg/day
                                        day.                    = 3.0 mg/kg/day........   based on 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
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Acute Dietary (General population      NOAEL = 300 mg/kg/day    FQPA SF = 1x             Prenatal developmental
 including infants and children)       UF = 100...............  aPAD = acute RfD/FQPA     toxicity study in rats
                                       Acute RfD = 3.0 mg/kg/    SF.                     LOAEL = 1,000 mg/kg/day
                                        day.                    = 3.0 mg/kg/day........   based on 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
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Chronic Dietary (All populations)      NOAEL = 9.7 mg/kg/day    FQPA SF = 1x             Chronic study in dogs
                                       UF = 100...............  cPAD = chronic RfD/FQPA  LOAEL = 33.0 mg/kg/day
                                       Chronic RfD = 0.1 mg/kg/  SF.                      based on decreased
                                        day.                    = 0.1 mg/kg/day........   body weight gain in
                                                                                          females
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Short-Term Dermal (1 to 7 days)            Hazard was not identified for quantification of risk. No systemic
 (Residential)                           toxicity was seen at the limit dose (1,000 mg/kg/day) following dermal
                                         applications and there is no concern for developmental toxicity in rats
                                                                       or rabbits.
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Intermediate-Term Dermal (1 week to        Hazard was not identified for quantification of risk. No systemic
 several months) (Residential)            toxicity was seen at the limit dose (1000 mg/kg/day) following dermal
                                         applications and there is no concern for developmental toxicity in rats
                                                                       or rabbits.
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Long-Term Dermal (several months to    dermal (or oral) study   LOC for MOE = 100        Chronic toxicity study
 lifetime) (Residential)               NOAEL= 9.7 mg/kg/day...   (Residential)            in dogs
                                       (dermal absorption rate                           LOAEL = 33.0 mg/kg/day
                                        = 58% when                                        based on decreased
                                        appropriate).                                     body weight gain in
                                                                                          females
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 7 days)    Inhalation (or oral)     LOC for MOE =            Prenatal developmental
 (Residential)                          study                   100 (Residential)......   toxicity study in rats
                                       NOAEL= 50 mg/kg/day....                           LOAEL = 500 mg/kg/day
                                       (inhalation absorption                             based on increased
                                        rate = 100%).                                     incidence of clinical
                                                                                          signs, decreased body
                                                                                          weight/body weight
                                                                                          gain, food
                                                                                          consumption, and food
                                                                                          efficiency
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week   Inhalation (or oral)     LOC for MOE =            Subchronic (6 month)
 to several months) (Residential)       study                   100 (Residential)......   toxicity study in dogs
                                       NOAEL = 8.8 mg/kg/day..                           LOAEL based on
                                       (inhalation absorption                             decreased body weight
                                        rate = 100%).                                     gain
----------------------------------------------------------------------------------------------------------------

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Long-Term Inhalation (several months   Inhalation (or oral)     LOC for MOE =            Chronic toxicity study
 to lifetime) (Residential)             study                   100 (Residential)......   in dogs
                                       NOAEL= 9.7 mg/kg/day...                           LOAEL = 33.0 mg/kg/day
                                       (inhalation absorption                             based on decreased
                                        rate = 100%).                                     body weight gain in
                                                                                          females
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Cancer (oral, dermal, inhalation)       Metolachlor has been classified as a Group C, possible human carcinogen.
                                         This classification was based on the occurrence of liver tumors in rats
                                        at the highest dose level tested (150 mg/kg/day). The carcinogenic risks
                                         for metolachlor have been quantitated using a non-linear approach, with
                                          a NOAEL of 15 mg/kg/day. However, the NOAEL of 15 mg/kg/day that was
                                         established based on liver tumors in rats 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.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. S-metolachlor, [2-
chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide], is a member of the chloroacetanilide class of 
herbicides. In this risk assessment the term s-metolachlor will refer 
to a metolachlor product which is enriched in the S-isomer. The term 
metolachlor will refer to a racemic mixture of the R and S isomers. 
Currently, there are permanent tolerances for metolachlor (40 CFR 
180.368) on a variety of crops and animal commodities. These tolerances 
range from 0.02 ppm to 30 ppm. There are also time-limited tolerances 
(in conjunction with section 18 uses) on grass, spinach, and tomatoes. 
Risk assessments were conducted by EPA to assess dietary exposures from 
metolachlor and 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\TM\) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the acute 
exposure assessments: The analyses assumed tolerance-level residues 
(with the exception of those with DEEM default processing factors) and 
100% crop treated for all commodities.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII) and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments: The analyses assumed tolerance-level residues (with the 
exception of those with DEEM default processing factors) and 100% crop 
treated for all commodities.
    iii. Cancer. Metolachlor has been classified as a Group C, possible 
human carcinogen. This classification was based on the occurrence of 
liver tumors in rats at the highest dose level tested (150 mg/kg/day). 
The carcinogenic risks for metolachlor have been quantitated using a 
non-linear approach, with a NOAEL of 15 mg/kg/day. However, the NOAEL 
of 15 mg/kg/day that was established based on liver tumors in rats 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.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for s-metolachlor in drinking 
water. Because the Agency does not have comprehensive monitoring data 
for both parent and the degradates of concern in drinking water, 
exposure from drinking water is being addressed through modeled 
estimated environmental concentrations (EECs) and the use of drinking 
water levels of comparison (DWLOCs). This assessment includes 
concentrations of parent metolachlor and the degradates metolachlor 
ethanesulfonic acid (ESA) and metolachlor oxanilic acid (OA). Although 
it was determined by the Agency that the ESA and OA metabolites appear 
to be less toxic than parent metolachlor, they are included in this 
risk assessment because they were found in greater abundance than the 
parent in water monitoring studies.
    The surface water EECs were derived from the National Water Quality 
Assessment Database (parent) and the FIRST Model (ESA and OA 
metabolites). The SCI-GROW Model was used to generate all ground-water 
EECs For a screening-level assessment for surface water EPA will 
generally use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 
model). The FIRST model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. While both FIRST and 
PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS 
model includes a percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk

[[Page 278]]

assessment process, the Agency does not use estimated environmental 
concentrations (EECs) from these models to quantify drinking water 
exposure and risk as a %RfD or %PAD. Instead drinking water levels of 
comparison (DWLOCs) are calculated and used as a point of comparison 
against the model estimates of a pesticide's concentration in water. 
DWLOCs are theoretical upper limits on a pesticide's concentration in 
drinking water in light of total aggregate exposure to a pesticide in 
food, and from residential uses. Since DWLOCs address total aggregate 
exposure to metolachlor and s-metolachlor they are further discussed in 
the aggregate risk sections below.
    Based on the National Water Quality Assessment Database (parent) 
and the FIRST Model (ESA and OA metabolites) and SCI-GROW models the 
estimated environmental concentrations (EECs) of parent metolachlor and 
its degradates for acute exposures are estimated to be 201 parts per 
billion (ppb) (parent: 77.6 ppb, ESA: 31.9 ppb, and OA: 91.4 ppb) for 
surface water and 103 ppb (parent: 5.5 ppb, ESA: 65.8 ppb, and OA: 31.7 
ppb) for ground water. The EECs for chronic exposures are estimated to 
be 92 ppb (parent: 4.3 ppb, ESA: 22.8 ppb, and OA: 65.1 ppb) for 
surface water and 103 ppb (parent: 5.5 ppb, ESA: 65.8 ppb, and OA: 31.7 
ppb) for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    i. Handlers. Metolachlor and s-metolachlor are registered (as an 
emulsifiable concentrate formulation) for use on lawn, turf (including 
sod farms), golf courses, sports fields, and ornamental gardens. 
Although metolachlor is not labeled as a restricted-use pesticide, it 
is not intended for homeowner purchase or use. On this basis, a 
residential handler is not expected to be exposed to residues of 
metolachlor and s-metolachlor. Therefore, a residential handler 
assessment was not conducted.
    ii. Postapplication. There is potential for postapplication 
exposure to adults and children resulting from the use of metolachlor/
s-metolachlor on residential lawns. Although the use sites for 
metolachlor and s-metolachlor vary from golf courses to ornamental 
gardens, the residential lawn scenario represents what the Agency 
considers to be 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 (one to 30 
days of exposure) only, based on a label specification of a six week 
interval before the re-application of metolachlor/s-metolachlor. The 
registrant has also indicated a label revision to limit application to 
one time per season.
    A short-term dermal endpoint was not selected because no systemic 
toxicity was seen at the limit dose of 1,000 mg/kg/day. As a result, a 
dermal risk assessment was not conducted and dermal risks are assumed 
to be minimal. Postapplication inhalation exposure is expected to be 
minimal since metolachlor and s-metolachlor are only applied in an 
outdoor setting, the vapor pressure is low (2.8 x 10-\5\ mm 
Hg at 25[]C), and the label specifies that 
residents should not re-enter treated areas until after sprays have 
dried.
    The following postapplication incidental oral scenarios which 
result from application to lawns and turf have been identified:
    a. Short-term oral exposure to toddlers and children following 
hand-to-mouth exposure;
    b. Short-term oral exposure to toddlers and children following 
object-to-mouth exposure; and
    c. 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.
    As 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.
    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.''
    EPA does not have, at this time, available data to determine 
whether s-metolachlor has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, s-
metolachlor does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that s-metolachlor has a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

C. 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. Developmental toxicity studies--i. Prenatal developmental 
toxicity study--Metolachlor--Rat. The maternal toxicity LOAEL was 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. The NOAEL was 300 mg/kg/day.
    The developmental toxicity LOAEL was conservatively established at 
1,000 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. The 
NOAEL was 300 mg/kg/day.
    ii. Prenatal developmental toxicity study--S-metolachlor--Rat. The 
maternal toxicity NOAEL was 50 mg/kg/day with a LOAEL of 500 mg/kg/day 
based on increased clinical signs of toxicity, decreased body weights 
and body weight gains and reduced food consumption and reduced food 
efficiency.
    No significant treatment related developmental toxicity was noted 
at the dose levels tested. The developmental toxicity NOAEL was equal 
to or greater

[[Page 279]]

than 1,000 mg/kg/day, the highest dose tested (HDT); a LOAEL was not 
reached.
    iii. Prenatal developmental toxicity study--Metolachlor--Rabbit. 
The maternal toxicity LOAEL was 360 mg/kg/day based on an increased 
incidence of clinical observations (persistent anorexia) and decreased 
body weight gain. The NOAEL was 120 mg/kg/day. The developmental 
toxicity LOAEL was not established. The NOAEL was 360 mg/kg/day.
    iv. Prenatal developmental toxicity study--S-metolachlor--Rabbit. 
The maternal toxicity NOAEL was 20 mg/kg/day with a LOAEL of 100 mg/kg/
day based on clinical signs of toxicity.
    No significant treatment related developmental toxicity was noted 
at the dose levels tested. The developmental toxicity NOAEL was equal 
to or greater than 500 mg/kg/day, HDT; a LOAEL was not reached.
    3. Reproductive toxicity study. No reproduction studies with s-
metolachlor are available, however, in the two-generation reproduction 
study with metolachlor in rats, there was no evidence of parental or 
reproductive toxicity at approximately 80 mg/kg/day, HDT. At this dose, 
there was a minor decrease in fetal body weight beginning at lactation 
day 4; the NOAEL was approximately 25 mg/kg/day. Since a similar body 
weight decrease was not seen on lactation day 0, the cause of the 
effect on later lactation days was most likely due to exposure of the 
pups to metolachlor in the diet and/or milk and therefore is not 
evidence of an increased quantitative susceptibility in post-natal 
animals.
    The parental toxicity LOAEL was not established. The NOAEL was 1000 
ppm (F0 males/females: 75.8/85.7 mg/kg/day; F1males/females: 76.6/84.5 
mg/kg/day).
    The reproductive toxicity LOAEL was not established. The NOAEL was 
1000 ppm (F0 males/females: 75.8/85.7 mg/kg/day; F1males/females: 76.6/
84.5 mg/kg/day).
    The offspring LOAEL was conservatively established at 1000 ppm (F0 
males/females: 75.8/85.7 mg/kg/day; F1males/females: 76.6/84.5 mg/kg/
day) based on decreased body weight in F1 and F2 litters. The NOAEL is 
300 ppm (F0 males/females: 23.5/ 26.0 mg/kg/day; F1males/females: 23.7/
25.7 mg/kg/day).
    4. Prenatal and postnatal sensitivity. The data bases for prenatal 
developmental toxicity for metolachlor and s-metolachlor are considered 
complete. The prenatal developmental studies in the rat and rabbit with 
both metolachlor and s-metolachlor revealed no evidence of a 
qualitative or quantitative susceptibility in fetal animals. No 
significant developmental toxicity was observed in most studies even at 
the HDT.
    The data base for reproductive toxicity of metolachlor is 
considered complete. No reproduction studies with s-metolachlor are 
available. In the two-generation reproduction study with metolachlor in 
rats, there was no evidence of parental or reproductive toxicity at 
approximately 80 mg/kg/day, HDT. At this dose, there was a minor 
decrease in fetal body weight beginning at lactation day 4; the NOAEL 
was approximately 25 mg/kg/day. Since a similar body weight decrease 
was not seen on lactation day 0, the cause of the effect on later 
lactation days was most likely due to exposure of the pups to 
metolachlor in the diet and/or milk and therefore is not evidence of an 
increased quantitative susceptibility in post-natal animals.
    5. Conclusion. There is a complete toxicity data base for s-
metolachlor when bridged with the database for metolachlor and exposure 
data are complete or are estimated based on data that reasonably 
accounts for potential exposures. EPA determined that the 10X safety 
factor to protect infants and children should be removed. The FQPA 
factor is removed because:
    i. The toxicological database is complete for FQPA assessment;
    ii. There is no indication of quantitative or qualitative increased 
susceptibility of rats or rabbits to in utero and/or postnatal 
exposure;
    iii. A developmental neurotoxicity study is not required; and
    iv. The dietary (food and drinking water) and residential exposure 
assessments will not underestimate the potential exposures for infants 
and children.

D. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + chronic non-dietary, non-occupational exposure). 
This allowable exposure through drinking water is used to calculate a 
DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the Office of Water are used to calculate DWLOCs: 2 
liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to s-metolachlor in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of s-metolachlor on drinking water as a part of the aggregate risk 
assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to s-
metolachlor will occupy <1 % of the aPAD for the U.S. population, <1 % 
of the aPAD for females 13 years and older, <1 % of the aPAD for all 
infant and children subpopulations. In addition, despite the potential 
for acute dietary exposure to s-metolachlor in drinking water, after 
calculating DWLOCs and comparing them to conservative model estimated 
environmental concentrations of s-metolachlor in surface and ground 
water, EPA does not expect the aggregate exposure to exceed 100% of the 
aPAD, as shown in Table 2 of this unit:

[[Page 280]]



                    Table 2.-- Aggregate Risk Assessment for Acute Exposure to S-Metolachlor
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)*       (ppb)*       (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                          3.0          < 1          201          103    1.0 x 105
----------------------------------------------------------------------------------------------------------------
All Infants (< 1 year old)                               3.0           <1          201          103    3.0 x 104
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                 3.0           <1          201          103    3.0 x 104
----------------------------------------------------------------------------------------------------------------
Children (7-12 years old)                                3.0           <1          201          103    3.0 x 104
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                                3.0           <1          201          103    9.0 x 104
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old)                                  3.0           <1          201          103    1.0 x 105
----------------------------------------------------------------------------------------------------------------
Males (20+ years old)                                    3.0           <1          201          103    1.0 x 105
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years old)                                  3.0           <1          201          103   1.0 x 105
----------------------------------------------------------------------------------------------------------------
* Represents the combined value of parent plus the ESA and OA degradates.

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to s-
metolachlor from food will utilize 2 % of the cPAD for the U.S. 
population, 2 % of the cPAD for all infants < 1 year old and 3 % of the 
cPAD for children 1-6 years old. Based the use pattern, chronic 
residential exposure to residues of s-metolachlor is not expected. In 
addition, despite the potential for chronic dietary exposure to s-
metolachlor in drinking water, after calculating DWLOCs and comparing 
them to conservative model estimated environmental concentrations of s-
metolachlor in surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the cPAD, as shown in Table 3 of 
this unit:

             Table 3.-- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to 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          103         3400
----------------------------------------------------------------------------------------------------------------
All Infants (< 1 year old)                               0.1            2           92          103          980
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                 0.1            3           92          103          970
----------------------------------------------------------------------------------------------------------------
Children (7-12 years old)                                0.1            2           92          103          980
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                                0.1            1           92          103         3000
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old)                                  0.1            2           92          103         3400
----------------------------------------------------------------------------------------------------------------
Males (20+ years old)                                    0.1            1           92          103         3500
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years old)                                  0.1            1           92          103         3500
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    For metolachlor and 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 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 both metolachlor and s-
metolachlor, with the only difference in the calculations being 
different oral exposure values for metolachlor vs. s-metolachlor (based 
on different application rates).
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 640 for metolachlor and 1000 for 
s-metolachlor for children 1-6 years old (the only population sub-group 
of concern. These aggregate MOEs do not exceed the Agency's level of 
concern for aggregate exposure to food and residential uses. In 
addition, short-term DWLOCs were calculated and compared to the EECs 
for chronic exposure of s-metolachlor in ground water and surface 
water. After calculating DWLOCs and comparing them to the EECs for 
surface and ground water, EPA does not expect short-term aggregate 
exposure to exceed the Agency's level of concern, as shown in Table 4 
of this unit:

[[Page 281]]



          Table 4.-- Aggregate Risk Assessment for Short-Term Exposure to Metolachlor and 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 (1-6); Metolachlor                              640          100           92          103        4,200
----------------------------------------------------------------------------------------------------------------
Children (1-6); S-Metolachlor                          1,100          100           92          103        4,500
----------------------------------------------------------------------------------------------------------------

    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, 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. Metolachlor has been classified as a Group C, possible human 
carcinogen. This classification was based on the occurrence of liver 
tumors in rats at the highest dose level tested (150 mg/kg/day). The 
HED Cancer Assessment Review Committee has recommended that 
carcinogenic risks for metolachlor be quantitated using a non-linear 
approach, with a NOAEL of 15 mg/kg/day. However, the NOAEL of 15 mg/kg/
day that was established based on liver tumors in rats 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 from aggregate 
exposure to s-metolachlor residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    The Pesticide Analytical Manual (PAM) Vol. II, lists a GC/NPD 
method (Method I) for determining residues in/on plants and a GC/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.

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.

VI. Conclusion

    Therefore, the tolerance is established for the combined residues 
(free and bound) of the herbicide s-metolachlor [(S)-2-chloro-N-(2-
ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide, its R-
enantiomer 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 sweet potatoes at 0.2 ppm.

VII. 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 the 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-2002-0331 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 March 4, 
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

[[Page 282]]

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 VII.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 the docket ID number OPP-2002-0331, 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. 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).

VIII. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under section 
408 of the FFDCA. 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 FIFRA 
section 18 exemption under section 408 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.

IX. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other

[[Page 283]]

required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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


    Dated: December 20, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180-- [AMENDED]

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

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

    2. Section 180.368 is amended by designating the existing paragraph 
(b) as paragraph (b)(1) and adding a new paragraph (b)(2) to read as 
follows:


Sec.  180.368  Metolachlor; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions.
    (1) * * *
    (2) Time-limited tolerances are established for the combined 
residues (free and bound) of the herbicide s-metolachlor [(S)-2-chloro-
N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide], its 
R-enantiomer 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 connection with the use of the pesticide under section 18 
emergency exemptions granted by EPA. The tolerance is specified in the 
following table. The tolerances will expire and are revoked on the 
dates specified in the following table.

------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    Revocation Date
------------------------------------------------------------------------
Sweet potato                      0.2                 12/31/04
------------------------------------------------------------------------

* * * * *

[FR Doc. 03-5 Filed 1-2-03; 8:45 am]
BILLING CODE 6560-50-S