S-Metolachlor; Pesticide Tolerances

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: September 19, 2003 (Volume 68, Number 182)]
[Rules and Regulations]
[Page 54827-54834]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se03-12]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0300; FRL-7324-9]

S-Metolachlor; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of the herbicide S-metolachlor and its metabolites in or on asparagus;
carrot, roots; horseradish; onion, green; rhubarb; and swiss chard. The
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act (FQPA) of 1996.

DATES: This regulation is effective September 19, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0300,
must be received on or before November 18, 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: Hoyt Jamerson, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone
number: (703) 308-9368; e-mail address:jamerson.hoyt@epa.gov.
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 manufacturer.
Potentially affected entities may include, but are not limited to:
[sbull]
Crop production (NAICS 111)
[sbull]
Animal production (NAICS 112)
[sbull]
Food manufacturer (NAICS 311)
[sbull]
Pesticide manufacturer (NAICS 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

[[Page 54828]]

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-2003-0300. 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
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.regulations.gov/ 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 August 13, 2003 (68 FR 48373) (FRL-7320-
9), 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 (4E4420, 7E4916, 8E5029, 8E5030, 9E6055, and
2E6374) by IR-4, 681 U.S. Highway #1 South, North Brunswick, NJ
08902-3390. That notice included a summary of the petitions prepared by
Syngenta Crop Protection, Swing Road, Greensboro, NC 27641, the
registrant. There were no comments received in response to the notice
of filing.
The petitions requested that 40 CFR 180.368 be amended by
establishing tolerances 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 (CGA-37913)
and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone (CGA-
49751), each expressed as the parent compound, in or on asparagus at
0.1 part per million (ppm) (9E6055); carrot, roots at 0.1 ppm (7E4916);
horseradish at 0.1 ppm (7E4916); onion, green at 0.2 ppm (2E6374);
pepper, bell at 0.50 ppm (4E4420); pepper, nonbell at 0.50 ppm
(4E4420); rhubarb at 0.1 ppm (8E5029); and swiss chard at 0.1 ppm
(8E5030). IR-4 subsequently revised 7E4916 to propose tolerances for
carrot, roots at 0.20 ppm and horse radish at 0.20 ppm. IR-4 also
withdrew 4E4420 for pepper. IR-4 plans to submit a pesticide petition
proposing a tolerance for fruiting vegetable group, which includes bell
and nonbell pepper, later in 2003.
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....''
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, November 26, 1997 (62 FR 62961) (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 tolerances for combined residues of S-
metolachlor and its metabolites on asparagus at 0.10 ppm; carrot, roots
at 0.20 ppm; horseradish at 0.20 ppm; onion, green at 0.20 ppm; rhubarb
at 0.10 ppm; and swiss chard at 0.10 ppm. EPA's assessment of exposures
and risks associated with establishing the tolerances follows.

A. Toxicological Profile

Metolachlor is a choroacetanilide herbicide that was first
registered as a pesticide in 1976. Metolachlor is a racemic mixture
consisting of 50% each of the R-enantiomer (CGA 77101) and the S-
enantiomer (CGA 77102). The S-enantiomer is the herbicidally active
isomer. S-metolachlor is also a racemic mixture comprised of 88% S-
enantiomer and 12% R-enantiomer. 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 S-metolachlor as
well as the no observed adverse effect level (NOAEL) and the lowest
observed adverse effect level (LOAEL) from the toxicity studies
reviewed are discussed in Unit III.A. of the Federal Register of April
2, 2003 (68 FR 15945) (FRL-7299-8).

B. Toxicological Endpoints

The dose at which the NOAEL from the toxicology study identified as
appropriate for use in risk assessment is

[[Page 54829]]

used to estimate the toxicological level of concern (LOC). However, the
LOAEL is sometimes used for risk assessment if no NOAEL was achieved in
the toxicology study selected. An uncertainty factor (UF) is applied to
reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intraspecies 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 factors (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
Percent 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*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure.'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOE_cancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for S-metolachlor used for human risk assessment is discussed
in Unit III.B. of the final rule published in the Federal Register of
April 2, 2003 (68 FR 15945) (FRL-7299-8).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances established
for metolachlor (40 CFR 180.368(a)(1) and (c)) 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% less
than the historical use rate of metolachlor. Tolerances have also been
established (40 CFR 180.368(a)(2)) for the combined residues of S-
metolachlor, in or on a variety of raw agricultural commodities. Time-
limited tolerances are established for metolachlor and S-metolachlor
(40 CFR 180.368(b)) in support of section 18 emergency exemptions. Risk
assessments were conducted by EPA to assess combined 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 1 day or
single exposure. In conducting this acute dietary risk assessment, EPA
used the Dietary Exposure Evaluation Model (DEEM) software with the
Food Commodity Intake Database (FCID) which incorporates food
consumption data as reported by respondents in the U.S. Department of
Agriculture (USDA) 1994-1996 and 1998 nationwide Continuing Surveys of
Food Intake by Individuals (CSFII) and accumulated exposure to the
chemical for each commodity. A conservative Tier 1 acute dietary
exposure assessment was conducted for all labeled metolachlor and all
labeled and proposed S-metolachlor food uses using 100% crop treated
(CT) and tolerance level residues.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment, EPA used the DEEM software with the FCID which incorporates
food consumption data as reported by respondents in the USDA 1994-1996
and 1998 nationwide CSFII and accumulated exposure to the chemical for
each commodity. A conservative Tier 1 combined, chronic dietary
exposure assessment was conducted for all labeled metolachlor and all
labeled and proposed S-metolachlor food uses using 100% CT and
tolerance level residues.
2. Dietary exposure from drinking water. The environmental fate
data base is complete for S-metolachlor. Parent metolachlor/S-
metolachlor appear to be moderately persistent to persistent, and range
from mobile to highly mobile in different soils. Metolachlor and S-
metolachlor are expected to have similar degradation pathways and rates
in soil and water environments. This assessment includes concentrations
of parent metolachlor/S-metolachlor and the degradates metolachlor
ethane sulfonic acid (ESA) and metolachlor oxanilic acid (OA). Although
it was determined 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. No surface or ground water
monitoring studies that specifically target metolachlor/S-metolachlor
were available for the drinking water assessment. As a result, the
drinking water assessment for parent metolachlor/S-metolachlor is based
primarily on monitoring data from the following sources: The U.S.
Geological Survey (USGS) National Water Quality Assessment (NAWQA) data
base, the U.S. EPA STORET data base, the Acetochlor Registration
Partnership (ARP) data base, and two USGS reservoir monitoring studies.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The SCI-GROW model is used to predict pesticide
concentrations in shallow ground water. For a screening-level
assessment for surface water EPA will use FIRST (a Tier 1 model) before
using PRZM/EXAMS (a Tier 2 model). The FIRST model is a subset of the
PRZM/EXAMS model that uses a specific high-end runoff scenario for
pesticides. FIRST and PRZM/EXAMS incorporate an index reservoir
environment, and include a PC area factor as an adjustment to account
for the maximum PC coverage within a watershed ordrainage basin.
The acute estimated environmental concentration (EEC) of 77.6 parts
per billion (ppb) was selected from the NAWQA data base, and the
chronic EEC of 4.3 ppb was selected from the maximum annual time
weighted mean from the NAWQA data. These values represent the estimated
concentration of parent metolachlor/S-metolachlor in surface water, and
are supported by the metolachlor concentrations from the National
Contaminant Occurrence Data base representing analysis of treated
drinking water, as well as from model predictions using PRZM/EXAMS.
When the monitoring data and modeling data are considered together,
there is a general agreement between the various

[[Page 54830]]

sources of information used in the assessment.
Acute and chronic concentrations of parent metolachlor/S-
metolachlor are not expected to exceed 5.5 ppb in ground water (based
on SCI-GROW modeling). SCI-GROW estimates the upper bound 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. active ingredient/acre (the maximum application
rate).
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 application rate used for
metolachlor ESA and OA in the model 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. 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. Monitoring data suggest that the SCI-GROW
estimates for metolachlor ESA and OA are slightly over estimating the
potential impact of metolachlor/S-metolachlor use on ground water.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a percent reference dose (%RfD) or
percent population adjusted dose (%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/S-metolachlor they are further discussed in the
aggregate risk sections in Unit III.E.
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). There is the
potential for post-application exposure to adults and children
resulting from the use of S-metolachlor on residential lawns. Post-
application exposures from various activities following lawn treatment
are considered to be the most common and significant in residential
settings. Post-application exposure is considered to be short-term (1-
days of exposure), based on label directions limiting application to
one time per season.
A short-term dermal risk assessment was not conducted since no
systemic toxicity was observed at the limit dose of 1,000 milligrams/
kilogram/day (mg/kg/day) following dermal application and there is no
concern for developmental toxicity in rats and rabbits. Post-
application inhalation exposure is also expected to be minimal since S-
metolachlor is only applied outdoors, the vapor pressure is low and the
label specifies that residents should not reenter treated areas until
after the spray has dried.
The following post-application 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; (3) short-term oral exposure to toddlers and children
following soil ingestion. The Health Effect Division Standard Operating
Procedures for Residential Exposure Assessments (Draft, December 18,
1997) were used as a guideline for the residential post-application
assessment. Also, standard values for turf transferable residues, turf
transfer coefficients, and hand-to-mouth activities were used as
amended by Exposure Policy 12 (Science Advisory Panel on Exposure,
February 22, 2001). 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 active ingredient/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.
4. Cumulative effects from 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 has examined the common
mechanism potential for S-metolachlor and has concluded that S-
metolachlor should not be included with the chloroacetanilide
pesticides designated as a ``Common Mechanism Group.'' The Agency's
position is that only some chloroacetanailides, namely acetochlor,
alachlor and butachlor should be considered as a ``Common Mechanism
Group'' due to their ability to cause nasal turbinate tumors. Although
metolachlor does distribute to the nasal turbinates, and might produce
a quinonimine, it is not apparent from the available data that
metolachlor shares the same target site in the nasal tissue as
acetochlor, alachlor, and butachlor.
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 policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.

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

[[Page 54831]]

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 margin of exposure (MOE)
analysis or through using uncertainty (safety) factors in calculating a
dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. There is no indication of
quantitative or qualitative increased susceptibility of rats or rabbits
to in utero and/or postnatal exposure in the available toxicity data.
3. Conclusion. There is a complete toxicity data base and exposure
data are complete or are estimated based on data that reasonably
accounts for potential exposures. The FQPA Safety Factor for the
protection of infants and children has been reduced to 1X because: (1)
The toxicology data base 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. (4) the dietary
(food and drinking water) and non-dietary exposure (residential)
assessments will not under estimate the potential exposures for infants
and children from the use of metolachlor.

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the U.S. EPA 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 ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. The acute aggregate risk assessment addresses
potential exposure from combined residues of metolachlor/S-metolachlor
on food and total residues of metolachlor/S-metolachlor plus ESA and OA
degradates in drinking water (surface water and ground water). Using
the exposure assumptions discussed in this unit for acute exposure, the
acute dietary exposure from food to metolachlor/S-metolachlor will
occupy <1% of the aPAD for the U.S. population and all other population
subgroups. In addition, there is potential for acute dietary exposure
to metolachlor/S-metolachlor and the ESA and OA degradates in drinking
water. After calculating DWLOCs and comparing them to the EECs for
surface water and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the aPAD, as shown in the following Table 1:

Table 1.--Aggregate Risk Assessment for Acute Exposure to Metolachlor/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 <1 200.9 103 104856.1
----------------------------------------------------------------------------------------------------------------
Infants <1 year 3.0 <1 200.9 103 29931.45
----------------------------------------------------------------------------------------------------------------
Children 1 to 2 years old 3.0 <1 200.9 103 29917.76
----------------------------------------------------------------------------------------------------------------
Females 13 to 49 years old 3.0 <1 200.9 103 89915.55
----------------------------------------------------------------------------------------------------------------

2. Chronic risk. The chronic aggregate risk assessment addresses
potential exposure from combined residues of metolachlor/S-metolachlor
on food and total residues of metolachlor/S-metolachlor plus ESA and OA
degradates in drinking water (surface water and ground water). There
are no residential uses that result in chronic residential exposure to
S-metolachlor. EPA has concluded that chronic exposure to metolachlor/
S-metolachlor from food will utilize 2% of the cPAD for the U.S.
population, 4% of the cPAD for children 1 to 2 years old, the
subpopulations at greatest exposure and 1% of the cPAD for females 13
to 49 years old. In addition, there is potential for chronic dietary
exposure to metolachlor/S-metolachlor and ESA and OA degradates in
drinking water. After calculating DWLOCs and comparing them to the EECs
for surface water and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the cPAD, as shown in the following Table 2:

[[Page 54832]]

Table 2.--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
----------------------------------------------------------------------------------------------------------------
Infants <1 year 0.1 2 92.2 103 977.20
----------------------------------------------------------------------------------------------------------------
Children 1 to 2 years 0.1 4 92.2 103 959.75
----------------------------------------------------------------------------------------------------------------
Females 13 to 49 years 0.1 1 92.2 103 2962.11
----------------------------------------------------------------------------------------------------------------

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).
S-metolachlor is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for metolachlor and S-metolachlor.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in an aggregate MOE of 1,000 for children 1 to 2
years. This aggregate MOE does 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 metolachlor/S-metolachlor and ESA and OA degradates in
ground water and surface water. After calculating DWLOCs and comparing
them to the EECs for surface water and ground water, EPA does not
expect short-term aggregate exposure to exceed the Agency's level of
concern, as shown in the following Table 3:

Table 3.--Aggregate Risk Assessment for Short-Term Exposure to Metolachlor/S-Metolachlor
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate MOE Level of Surface Ground Short-Term
Population Subgroup (Food Concern Water EEC Water EEC DWLOC (ppb)
+Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Children 1 to 2 years old 1,000 100 92.2 103.3 4,000
----------------------------------------------------------------------------------------------------------------

5. Aggregate cancer risk for U.S. population. The NOAEL that was
established based on tumors in rats (15 mg/kg/day) is comparable to the
NOAEL of 9.7 mg/kg/day selected for cRfD. Therefore, the chronic
dietary end point is protective for cancer dietary exposure.
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 metolachlor/S-metolachlor residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

The Pesticide Analytical Manual (PAM) Vol. II, lists a Gas
Chromatography (GC)/NPD method (Method I) for determining residues in/
on plants and a GC/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. Field trial data were
obtained using adequate GC/NPD methods (AG-338 or AG-612), which are
modifications of Method I. Adequate data are available on the recovery
of metolachlor through Multi-residue Method Testing Protocols. The FDA
PEST DATA data base indicates that metolachlor is completely recovered
through Method 302, PAM Vol. I (3rd ed., revised 10/97).
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905;
e-mail address: residue methods@epa.gov.
B. International Residue Limits

No maximum residue limits for either metolachlor or S-metolachlor
have been established or proposed by Codex, Canada, or Mexico for any
agricultural commodity; therefore, there are no compatibility issues
with this action.

V. Conclusion

Therefore, tolerances are established 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 (CGA-37913)
and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone (CGA-
49751), each expressed as the parent compound, in or on asparagus at
0.10 ppm; carrot, roots at 0.20 ppm; horseradish at 0.20 ppm; onion,
green at 0.20 ppm; rhubarb at 0.10 ppm; swiss chard at 0.10 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.

[[Page 54833]]

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-2003-0300 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before November
18, 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 tompkins.jim@epa.gov,
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-2003-0300, 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: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Statutory and Executive Order Reviews

This final rule establishes tolerances under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exemptedthese 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
notcontain 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 tolerances in
this final rule, do not require the issuance of aproposed 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

[[Page 54834]]

``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 (59 FR 22951, 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: September 12, 2003.
Debra Edwards,
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 by alphabetically adding commodities to
the table in paragraph (a)(2) to read as follows:

Sec. 180.368 Metolachlor; tolerances for residues.

(a) * * *
(2) * * *

----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
Asparagus............................................. 0.10
* * * * *
Carrot, roots......................................... 0.20
* * * * *
Horseradish........................................... 0.20
Onion, green.......................................... 0.20
* * * * *
Rhubarb............................................... 0.10
* * * * *
Swiss chard........................................... 0.10
* * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 03-24014 Filed 9-16-03; 4:08 pm]

BILLING CODE 6560-50-S

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