[Federal Register Volume 68, Number 156 (Wednesday, August 13, 2003)]
[Notices]
[Pages 48373-48377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20643]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0260]; FRL-7320-9]


S-Metolachlor; Notice of Filing a Pesticide Petition to Establish 
a Tolerance for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket ID number OPP-2003-0260, must be 
received on or before September 12, 2003.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. 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 manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (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 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 ID number OPP-2003-0260. 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/.
     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.
     Certain types of information will not be placed in the EPA 
Dockets. Information claimed as CBI and other information whose 
disclosure is restricted by statute, which is not included in the 
official public docket, will not be available for public viewing in 
EPA's electronic public docket. EPA's policy is that copyrighted 
material will not be placed in EPA's electronic public docket but will 
be available only in printed, paper form in the official public docket. 
To the extent feasible, publicly available docket materials will be 
made available in EPA's electronic public docket. When a document is 
selected from the index list in EPA dockets, the system will identify 
whether the document is available for viewing in EPA's electronic 
public docket. 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. 
EPA intends to work towards providing electronic access to all of the 
publicly available docket materials through EPA's electronic public 
docket.
     For public commenters, it is important to note that EPA's policy 
is

[[Page 48374]]

that public comments, whether submitted electronically or on paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
     Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

     You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also, include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2003-0260. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID number OPP-2003-0260. Incontrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID number OPP-2003-0260.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID number OPP-2003-0260. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

     Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
     In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

     You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
     4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received pesticide petitions as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities

[[Page 48375]]

under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 
21 U.S.C. 346a. EPA has determined that these petitions contain data or 
information regarding the elements set forth in FFDCA section 
408(d)(2); however, EPA has not fully evaluated the sufficiency of the 
submitted data at this time or whether the data support granting of 
these petitions. Additional data may be needed before EPA rules on the 
petitions.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.


    Dated: August 4, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

     The petitioner's summary of the pesticide petitions is printed 
below as required by FFDCA section 408(d)(3). The summary of the 
petitions was prepared by Syngenta Crop Protection, 410 Swing Road, 
Greeensboro, NC 276419, and represents the view of the Syngenta Crop 
Protection. The petition summary announces the availability of a 
description of the analytical methods available to EPA for the 
detection and measurement of the pesticide chemical residues or an 
explanation of why no such method is needed.

 Syngenta Crop Protection

 PP 7E4916, 8E5029, 8E5030, 9E6055, and 2E6374

     EPA has received pesticide petitions (7E4916, 8E5029, 8E5030, 
9E6055, and 2E6374) from the Interregional Research Project Number 4 
(IR-4), 681 U.S. Highway 1 South, North Brunswick, NJ 08902 
proposing proposing, pursuant to section 408(d) of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 
180 by establishing tolerances for combined residues of s-metolachlor 
and its metabolites, determined as the derivatives, 2-(2-ethyl-6-
methylphenyl)amino-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-
5-methyl-3-morpholine, each expressed as the parent compound s-
metolachlor in or on the following raw agricultural commodities:
    1. PP 4E4420 proposes the establishment of tolerances for pepper, 
bell and pepper, nonbell at 0.50 part per million (ppm).
    2. PP 7E4916 proposes the establishment of a tolerance for carrot, 
root and horseradish at 0.1 ppm.
    3. PP 8E5029 proposes the establishment of a tolerance for rhubarb 
at 0.1 ppm.
    4. PP 8E5030 proposes the establishment of a tolerance for swiss 
chard at 0.1 ppm.
    5. PP 9E6055 proposes the establishment of a tolerance for 
asparagus at 0.1 ppm.
    6. PP 2E6374 proposes the establishment of a tolerance for onion, 
green at 0.2 ppm.
     EPA has determined that the petitions contain data or information 
regarding the elements set forth in section 408(d)(2) of the FFDCA; 
however, EPA has not fully evaluated the sufficiency of the submitted 
data at this time or whether the data supports granting of the 
petitions. Additional data may be needed before EPA rules on the 
petitions.

A. Residue Chemistry

    1. Plant metabolism. [The qualitative nature of S-metolachlor 
residues in plants is adequately understood based upon available EPA 
approved corn, potato, and soybean metabolism studies. The metabolism 
of S-metolachlor involves conjugation with glutathione, breakage of 
this bond to form the mercaptan, conjugation of the mercaptan with 
glucuronic acid, hydrolysis of the methyl ether, and conjugation of the 
resultant alcohol with a neutral sugar. EPA has determined that 
residues of concern in plants include parent and metabolites, 
determined as the derivatives CGA-37913 and CGA-49751.
    2. Analytical method. The Pesticide Analytical Manual (PAM) Vol. 
II, Pesticide Regulation Section 180.368 lists a gas chromatography/
nitrogen phosphorous detector (GC/NPD) method (Method 1) for 
determining residues in or on plants and a gas chromatography/mass 
spectrometry methos (GC/MSD) method for determining residues in 
livestock commodities. These methods determine residues of S-
metolachlor and its metabolites as either CGA-37913 or CGA-49751 
following acid hydrolysis. The limit of quantitation (LOQ) for the 
method is 0.03 ppm for CGA-37913 and 0.05 ppm for CGA-49751.
    3. Magnitude of residues.--i. Asparagus. Magnitude of residue 
trials were conducted under the direction of IR-4 in EPA regions 2, 5, 
and 11 in New Jersey, Michigan, and Washington. Applications were made 
pre-emergence to dormant asparagus in the spring and samples were 
collected for analysis 16 days after application. There were no 
detectable residues found in asparagus at harvest.
    ii. Carrot. Field trials were conducted in Florida, Michigan, and 
New York to support the proposed tolerance for S-metolachlor in or on 
carrots grow on high organic matter (muck) soils.
    iii. Green onion. Magnitude of residue trials were completed by IR-
4 in New York, California, and Michigan (EPA region 1, 10, and 5, 
respectively). One post-emergence broadcast application was made when 
the onions had 2 true leaves. Marketable green onion plants were 
collected 43 to 45 days following the application. Maximum residues 
found were 0.168 ppm.
    iv. Rhubarb and Swiss chard. As the EPA review announced in the 
October 2002 TRED has confirmed that a 0.1 ppm tolerance is appropriate 
for S-metolachlor in celery and as celery is the representative crop 
for the Leafy Petiole Subgroup, IR-4 has proposed tolerances be 
established for rhubarb and Swiss chard.

B. Toxicological Profile

    1. Acute toxicity. [The data base for acute toxicity for S-
metolachlor is complete. S-metolachlor is moderately acutely toxic 
(Toxicity Category III) by the oral and dermal route and relatively 
non-toxic (Toxicity category IV) by the inhalation route. It causes 
slight eye irritation (Toxicity Category III) and is non-irritating 
dermally (Toxicity Category IV); the active ingredient was found to be 
positive in a dermal sensitization test but this effect is mitigated in 
end-use product formulations.]
    2. Genotoxicty. The data base for S-metolachlor has been deemed to 
be adequate by EPA. Gene mutation studies (Guideline 870.5100), 
micronucleus (Guideline 870.5395), and unscheduled DNA synthesis 
(Guideline 870.5550) studies have recently been reviewed and approved 
by EPA. There is no evidence of a mutagenic or cytogentic effect in 
vivo or in vitro with S-metolachlor.
    3. Reproductive and developmental toxicity. The data base for 
developmental and reproductive toxicity for S-metolachlor are 
considered complete according to EPA reviews. The prenatal 
developmental studies in the rat and rabbit with S-metolachlor revealed 
no evidence of a qualitative or quantitative susceptibility in fetal 
animals. No significant developmental toxicity was observed in most 
studies even at the highest doses tested. In a two-generation 
reproduction study, there was no evidence of parental or reproductive 
toxicity at the highest dose tested (80 mg/kg/day). The results 
indicate that S-metolachlor is not

[[Page 48376]]

embryotoxic or teratogenic in either species at maternally toxic doses.
    4. Subchronic toxicity. In a 90-day dietary study in rats with S-
metolachlor, no effects were observed in male or females at 208 and 236 
mg/kg/day, respectively. In another 90-day dietary study in rats, 
decreased body weight, reduced food consumption and food efficiency in 
both sexes and increased kidney weight in males at 150 mg/kg/day; the 
NOAEL was 15 mg/kg/day. A 90-day dog study with S-metolachlor in dogs 
has been accepted by EPA; no effects were observed in males and females 
at 62 mg/kg/day and 74 mg/kg/day, respectively, the highest doses 
tested.
    5. Chronic toxicity. A combined chronic toxicity/carcinogenic study 
in the rat satisfies the requirements for both the chronic toxicity and 
carcinogenicity studies. No significant chronic toxicity was found in 
either rats or dogs. In the rat, a decrease in body weight was observed 
at the highest dose tested. In the chronic dog study that supports S-
metolachlor, the only adverse effect was decreased body weight gain in 
females at 33 mg/kg/day; the NOAEL was 10 mg/kg/day.
    6. Animal metabolism. In animals, S-metolachlor is extensively 
absorbed, rapidly metabolized and almost totally eliminated in the 
excreta of rats, goats, and poultry. Metabolism in animals proceeds 
through common Phase 1 intermediates and glutathione conjugation.
    7. Metabolite toxicology. The metabolism of S-metolachlor has been 
well characterized in standard FIFRA metabolism studies. S-metolachlor 
does not readily undergo dealkylation to form an aniline or quinone 
imine as has been reported for other members of the chloroacetanilide 
class of chemicals. Therefore, it is not appropriate to include S-
metolachlor with the group of chloroacetanilides that readily undergo 
dealkylation, producing a common toxic metabolite (quinone imine). New 
toxicology data submitted by Syngenta demonstrate that the S-
metolachlor metabolites ethane sulfonic acid (CGA 354743) and oxanilic 
acid (CGA 51202) are not absorbed by mammalian systems and / or have a 
significantly lower level of mammalian toxicity when compared to 
parent.
    8. Endocrine disruption. S-Metolachlor does not belong to a class 
of chemicals known or suspected of having adverse effects on the 
endocrine system. There is no evidence that S-metolachlor has any 
effect on endocrine function in developmental or reproduction studies. 
Furthermore, histological investigation of endocrine organs in the 
chronic dog, rat and mouse studies did not indicate that the endocrine 
system is targeted by S-metolachlor, even at maximally tolerated doses 
administered for a lifetime. There is no evidence that S-metolachlor 
bioaccumulates in the environment.

C. Aggregate Exposure

    1. Dietary exposure. A Tier III/IV chronic dietary exposure 
analysis was conducted on S-metolachlor using field trial and market 
basket survey residues. Field trial residues were adjusted for percent 
of crop treated whereas market basket residues were not, since this 
information is inherent in the data. The percent of crop treated was 
assumed to be 100% for all commodities for which no percent of crop 
treated information was available. The chronic assessment was conducted 
for S-metolachlor using the Dietary Exposure Evaluation Model 
(DEEMTM, version 7.76) by Exponent and food consumption 
information from USDA's 1994-96 Continuing Survey of Food Intake by 
Individuals (CSFII) and the Supplemental CSFII children's survey 
(1998). For this chronic assessment, the field trial values were 
averaged and entered into the DEEMTM software.
     Syngenta Market Basket Survey (SMBS) S-metolachlor data were 
available for the following commodities: milk, potatoes and tomatoes. 
The Syngenta market basket survey was conducted from September 1999 
through September 2000. Following the Agency tier ranking system, these 
chronic dietary assessments are considered as Tier III (utilizing field 
trial data) and Tier IV (utilizing SMBS and PDP data) assessments.
     S-metolachlor is not considered acutely toxic and therefore acute 
dietary exposure was not determined; however, in the October 2002 TRED 
EPA conducted an acute assessment of the majority of the crops included 
in this petition and determined acute risks to be <1% of the aPAD in 
the most exposed population subgroup.
     The chronic RfD for S-metolachlor is 0.10 mg/kg body weight/day 
and is based on a one-year dog study with a NOEL of 9.7 mg/kg body 
weight/day and a safety factor of 100X. No additional FQPA safety 
factor is required; nor was applied in this assessment.
    i. Food. The risk from chronic dietary exposure to S-metolachlor is 
considered to be very low. The percentages of the chronic RfD ranged 
from 0.17% for Seniors to 0.64% for Children 1-2 years old, 
theoretically the most exposure population subgroup.
    ii. Drinking water. Other potential sources of exposure of the 
general population to residues of S-metolachlor are residues in 
drinking water and exposure from non-occupational sources. The 
degradation of S-metolachlor is microbially mediated with an aerobic 
soil metabolism primary half-life of less than 30 days and subsequently 
soil binding predominates. S-metolachlor Koc's vary from 110- 369. S-
metolachlor is stable to hydrolysis and while aqueous and soil 
photolysis occur, they are not expected to be prominent pathways in the 
environment.
     The predominant crop for S-metolachlor is corn and accordingly an 
Index Reservoir PRZM/EXAMS was run using EPA's standard corn scenario. 
The model simulated two applications to the same plot: pre-emergence 
(2.67 kg ai/ha) and post-emergence (1.50 kg a.i./ha). The mean annual 
average estimated environmental concentrations (EEC) was 11.77 ppb. It 
should be noted that extensive monitoring data suggests that this EEC 
is a conservative estimate. For the vast majority of locations sampled, 
the peak measured concentration does not approach 12 ppb, and the 
annual average would be expected to be much lower.
     The Chronic drinking water levels of concern (DWLOC) was 
calculated based on a cRfD of 0.097 mg/kg/day. Non-nursing infants are 
the most sensitive subpopulation and their DWLOC is estimated to be 544 
ppb which corresponds to a %cRfD value of 2.2% with an MOE value of 
4621. Thus, the DWLOC is considerably higher than the EEC of 11.77 ppb 
and the MOE is well above the benchmark value of 100.
    2. Non-dietary exposure. S-metolachlor is labeled for use on warm-
season turf and landscape ornamentals. Although, it is primarily used 
on sod farms and commercial landscape ornamentals, it can be used by 
licensed pest control operators (PCO) or lawn care operators (LCO) on 
residential turf. Since S-metolachlor can only be applied to warm-
season turf varieties (bermudagrass, Zoysiagrass, St. Augustinegrass, 
and Centipedegrass), its use on turf is limited to the southern states.
     Non-dietary residential exposure may occur to homeowners or 
children as a result of exposure during re-entry activities. Using 
surrogate dislodgeable foliar residue data, and conservative standard 
EPA exposure scenarios, exposure through the dermal route was 
calculated. Based on the use pattern, which restricts to number of 
application to one per year, only short-term risks need to be 
considered. The relevant

[[Page 48377]]

toxicological endpoint for short-term dermal risks is the NOEL of 100 
mg/kg/day from a 21-day dermal toxicity study in rabbits. No acute oral 
hazard has been identified following an acute exposure to S-metolachlor 
and, therefore, no nondietary assessment is needed.
     The short-term dermal post-application risks for adults and 
children are acceptable, ranging from 520 to 870. These risk estimates 
exceed the EPA's level of concern for S-metolachlor (all MOEs are 
greater than 100).
     Aggregate exposure. (Drinking Water and Dietary Exposure). Using 
the total MOE equation for the determination of aggregate chronic 
exposure (food and drinking water only) resulted in an aggregate MOET 
of >4,000 for the most sensitive subpopulation, non-nursing infants. 
For this particular subpopulation, there are no non-dietary exposure 
contributions to the MOET aggregate value.

D. Cumulative Effects

     EPA has examined the common mechanism potential for S-metolachlor 
and has concluded that S-metolachlor should not be included with some 
pesticides that comprise the class of chloroacetanilides included in a 
``Common Mechanism Group.'' Therefore, a cumulative assessment is not 
necessary for S-metolachlor.

E. Safety Determination

    1. U.S. population. Based on the aggregate assessment described 
above and the completeness and reliability of the toxicity data, it is 
concluded that aggregate exposure to S-metolachlor (including the 
proposed uses) in food will utilize less than 0.1 percent of the cRfD 
for the U.S. population. EPA generally has no concern for exposures 
below 100 percent of the RfD because the RfD represents the level at or 
below which daily aggregate dietary exposure over a lifetime will not 
pose appreciable risks to human health. Despite the potential for 
exposure to S-metolachlor in drinking water and from non-dietary, non-
occupational exposures, the assessment presented above demonstrates 
that the high levels of safety exist for current and proposed uses of 
S-metolachlor; it is not expected that aggregate exposure from all 
sources will exceed 100% of the RfD. Therefore, one can conclude there 
is a reasonable certainty that no harm will result from aggregate 
exposure to S-metolachlor.
    2. Infants and children. [FFDCA section 408 provides that EPA may 
apply an additional safety factor for infants and children in the case 
of threshold effects to account for pre- and post-natal toxicity and 
the completeness of the database. Based on the current toxicological 
data requirements, the database relative to pre- and post-natal effects 
for children is complete. A full consideration of the available 
reproductive toxicity data supporting S-metolachlor demonstrates no 
increased sensitivity to infants and children. Therefore, it is 
concluded that an additional uncertainty factor is not warranted to 
protect the health of infants and children and that the cRfD at 0.1 mg/
kg/day is appropriate for assessing aggregate risk to infants and 
children from use of S-metolachlor.
     Based on the aggregate assessment described above, the percent of 
the cRfD that will be utilized by aggregate exposure to residues of S-
metolachlor is less than 0.7 percent for all children subpopulations. 
EPA generally has no concern for exposures below 100% of the RfD 
because the RfD represents the level at or below which daily aggregate 
dietary exposure over a lifetime will not pose appreciable risks to 
human health. Despite the potential for exposure to S-metolachlor in 
drinking water and from non-dietary, non-occupational exposure, the 
assessment described above demonstrates that it is not expected that 
aggregate exposure from all sources provides for a large margin of 
safety and will exceed 100% of the RfD. Therefore, based on the 
completeness and reliability of the toxicity data and the exposure 
assessment, it is concluded there is a reasonable certainty that no 
harm will result to infants and children from aggregate exposure to S-
metolachlor residues.

F. International Tolerances

     There are no Codex Alimentarius Commission (CODEX) maximum residue 
levels (MRL's) established for residues of S-metolachlor in or on raw 
agricultural commodities.

[FR Doc. 03-20643 Filed 8-12-03; 8:45 am]
BILLING CODE 6560-50-S