[Federal Register Volume 68, Number 182 (Friday, September 19, 2003)]
[Rules and Regulations]
[Pages 54827-54834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24014]


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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:[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide 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 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

    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 (MOEcancer = 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 
[email protected].

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 [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2003-0300, 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: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. 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 (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: 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