[Federal Register Volume 68, Number 19 (Wednesday, January 29, 2003)]
[Notices]
[Pages 4470-4475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2019]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0318; FRL-7281-3]


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-2002-0318, must be 
received on or before February 28, 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: Joanne I. Miller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: 703-305-6224; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] (NAICS 111), e.g., Crop Production
    [sbull] (NAICS 112), e.g., Animal Production
    [sbull] (NAICS 311), e.g., Food Manufacturing
    [sbull] (NAICS 32532), e.g., Pesticide Manufacturing
    [sbull] (NAICS 32561),e.g., Antimicrobial Pesticide
    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 NAICS codes have been provided to assist you and others 
in determining whether this action might apply to certain entities. To 
determine whether you or your business may be affected by this action, 
you should carefully examine the applicability provisions in this 
Notice of Filing a Pesticide Petition to Establish a Tolerance for a 
Certain Pesticide Chemical in or on Food regarding the applicability of 
this action to a particular entity , consult the person listed under 
FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2002-0138. 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.,

[[Page 4471]]

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 
that public comments, whether submitted electronically or in 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-2002-0318. 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-2002-0318. In contrast 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-2002-0318.
    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-2002-0318. 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

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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 a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains 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 the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

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

    Dated: January 16, 2003.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    The petitioner summaries of the pesticide petitions are printed 
below as required by FFDCA section 408(d)(3). The summaries of the 
petitions was prepared by the petitioners and represent the views of 
the petitioners. 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.

6E4638, 8E5011, 6F6751, and 7F4897

    EPA has received pesticide petitions (PP 6E4638, 8E5011, 6F6751, 
and 7F4897) from the Interregional Research Project No. 4 (IR-4), and 
Syngenta Crop Protection, New Jersey Agricultural Experiment Station, 
P.O. Box 231, Rutgers University, New Brunswick, NJ 08903 and 410 Swing 
Road, Greensboro, NC 27419, proposing pursuant to section 408(d) of the 
FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish 
tolerances for residues of S-metolachlor on grasses grown for seed 
(6E4638), spinach (8E5011), sugar beets and sunflowers (7F4897), and 
tomato (6F6751). Grasses grown for seed and tomato petitions have been 
the subject of previous Federal Register notices on March 4, 1998, and 
April 14, 1997, these petitions have been amended to request the 
establishment of tolerances for S-metolachlor, by establishing a 
tolerance for residues of S-metolachlor [acetamide, 2-chloro-N-(2-
ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)-, (S)] (CAS Number 
873921-9) and its metabolites, determined as the derivatives, 2-[(2-
ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-
2-hydroxy-5-methyl-3-morpholinone, each expressed as the parent 
compound in or on the raw agricultural commodity (RAC) grass forage, 
grass hay, spinach, sugar beet, sugar beet dried pulp, sugar beet 
molasses, sugar beet tops, sunflower, sunflower meal, and tomato at 12, 
0.2, 0.5, 0.5, 1.0, 3.0, 15.0, 0.5, 1.0, and 0.1 (respectively) parts 
per million (ppm). EPA has determined that the petition contains 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 petition. Additional data may be needed before EPA rules on the 
petition.

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 (Sec.  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 detector (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-Grasses grown for seed. This petition is 
supported by six field residue tests conducted on grasses grown for 
seed. Quantitative measurements of the metolachlor hydrolysates, CGA-
37913 and CGA-49751, were made for all samples and reported as parent 
equivalents. In all residue tests, the active ingredient (a.i.) was 
applied post-emergence at a maximum of 2.0 lbs. a.i./acre at the early 
regrowth stage prior to weed emergence. The maximum residue in forage 
was 27 ppm (60-day PHI). Residues in forage declined with increasing 
PHI. Maximum residues in straw, screenings, and seed were 0.11 ppm, 
0.04 ppm, and < 0.08 ppm, respectively.
    i. Spinach. Magnitude of residue data on the spinach were collected 
from 12 field trials. In 1994, four field trials were conducted to 
collect magnitude of residue data in or on spinach. The treated plots 
each received one post-seeding, pre-emergence, broadcast

[[Page 4473]]

application of a.i., targeting a rate of 1.0 lb a.i./acre. The spinach 
was harvested 45 to 56 days after the application. No residues of CGA-
49751 were detected above the LOQ, 0.05 ppm, in spinach samples from 
two of the three remaining sites. CGA-49751 was detected at 0.1 ppm in 
one treated sample from Arkansas. Residues of CGA-37913 were detected 
above the LOQ in samples from all three field sites. The CGA-37913 
residues ranged from < 0.10 ppm to 0.33 ppm. The resulting maximum 
total combined residues of CGA-49751 + CGA-37913 in samples treated at 
the 1.0 lb a.i./acre rate is < 0.38 ppm.
    In 1995, eight field trials were conducted in Maryland, Michigan, 
New Jersey, Texas, and California. Each of the eight trials consisted 
of at least an untreated control and one treated plot, where the 
treated plot received one post-seeding, pre-emergence, broadcast 
application of a.i., targeting a rate of 1.0 lb a.i./acre. The 
California and Texas trials also included a second treated plot, which 
received post-seeding, pre-emergence, broadcast application of a.i., 
targeting a rate of 2.0 lbs a.i./acre. The spinach was harvested 34 to 
69 days after the application. The residues found in 1995 spinach 
samples, treated targeting the 1.0 lb a.i./acre rate, ranged from less 
than the LOQ, 0.05 ppm, to 0.85 ppm of CGA-49751, and ranged from less 
than the LOQ, 0.03 ppm, to 0.107 ppm for CGA-37913 for a maximum 
combined residue of 0.174 ppm. In the spinach samples treated targeting 
the 2.0 lbs a.i./acre rate, CGA-49751 residues ranged from < 0.05 ppm 
to 0.188 ppm and CGA-37913 residues ranged from 0.032 ppm to 0.075 ppm. 
The maximum combined residues for a.i. at the 2.0 lbs a.i./acre 
application rate is 0.263. The maximum residues found in or on spinach 
treated with the proposed labeled rate of 1.0 lbs a.i./acre, was < 0.38 
ppm for the combined residues of CGA-37913 and CGA-49741. Residues in 
spinach treated at the 2.0 lbs a.i./acre application rate did not 
exceed this combined residues, with a maximum combined residue of 0.263 
ppm. IR-4 is conducting additional research to support the 2.0 lbs 
a.i./acre application rate.
    ii. Sugarbeets. Eleven sugar beet trials were conducted using six 
different treatment scenarios. The maximum 1X use rate was 4.0 lbs. 
a.i./acre applied preplant surface or preplant incorporated (1.33 lbs. 
a.i./acre) plus a post foliar spray (2.66 lbs. a.i./acre). 3X and 5X 
treatments were also conducted. Maximum residues at the 1X rate were 14 
ppm in sugar beet tops and 0.32 ppm in sugar beet roots. In the 
processing study, it was determined that tolerances would be required 
in dried pulp and molasses, but not in refined sugar.
    iii. Sunflower. A total of 15 residue trials were conducted in 
major sunflower growing areas of the United States. Applications were 
made at 1X and 2X the maximum labeled rate of 3.0 lbs. a.i./acre. 
Processing was also conducted with seeds processed into meal, hulls, 
crude oil, refined oil and soapstock. Based on these studies, 
tolerances are proposed in sunflower seed at 0.5 ppm and in sunflower 
meal at 1.0 ppm.
    iv. Tomato. Thirteen field trials were conducted in major tomato 
production areas across the United States. Both tomato and its 
processed fractions were analyzed for residues of parent, measured as 
CGA-37913 and CGA-49751. One application at 3.0 lbs. a.i./acre (1X) was 
made post-foliar to tomato transplants. Exaggerated rate applications 
(2X, 3X and 5X) were also made. Two of the 13 trials were used for 
processing into tomato commodity products. No residues LOQ of 0.08 ppm) 
were found at the 1X rate in the RAC tomatoes. In processed commodities 
at the 1X rate of 3.0 lbs a.i./acre, residues of parent were found 
below the method LOQ in tomato puree (0.4 ppm) and above the method LOQ 
in dry pomace and tomato paste (0.16 and 0.13 ppm, respectively). 
Because residues in tomato puree and paste (commodities listed in Table 
1 of OPPTS 860.1000 as processed commodities of tomatoes) are less than 
2X the LOQ of 0.08 ppm, tolerances are not required according to OPPTS 
860.1520 (f)(3).

B. Toxicological Profile

    1. Acute toxicity. The database 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 a.i. was found to be positive in a 
dermal sensitization test but this effect is mitigated in end-use 
product formulations.
    2. Genotoxicty. The database 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 database 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 does tested (HDT). In a 2-generation 
reproduction study, there was no evidence of parental or reproductive 
toxicity at the HDT (80 millograms/kilogram/day (mg/kg/day)). The 
results indicate that S-metolachlor is not 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 
no observe adversed effect level (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 HDT.
    5. Chronic toxicity. The database that supports S-metolachlor is 
considered adequate by EPA. 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 HDT. 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. The database for S-metolachlor is considered 
to be complete. 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. The 
metabolites found are considered to be toxicologically similar to 
parent. 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, as EPA has agreed, it 
is not appropriate to include S-metolachlor with the group of

[[Page 4474]]

chloroacetanilides that readily undergo dealkylation, producing a 
common toxic metabolite (quinone imine).
    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 (MB) residues. Field trial residues were adjusted for PCT 
whereas MB residues were not, since this information is inherent in the 
data. The PCT was assumed to be 100% for all commodities for which no 
PCT 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 Department of Agriculture (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 SMBS 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.
    The chronic reference dose (RfD) for S-metolachlor is 0.10 mg/kg 
body weight/day and is based on a 1-year dog study with a NOAEL 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. S-
metolachlor is not considered acutely toxic and therefore, acute 
dietary exposure was not determined. For the purpose of aggregate 
assessment, the exposure values were expressed in terms of margin of 
exposure (MOE) which was calculated by dividing the NOAEL by the 
exposure for each population subgroup. The benchmark MOE for this 
assessment is 100.
    i. Food. The risk from chronic dietary exposure to S-metolachlor is 
considered to be very low. Based on worst-case assumptions, the chronic 
exposure assessment did not result in any MOE less than 55,428 for even 
the most impacted population subgroup (children 1-6 years). Syngenta 
believes that the MOE for chronic exposure would be well above 100 for 
any population group. A MOE of 100 or more is considered satisfactory. 
The percent of the chronic RfD ranged from 0.05% for seniors to 0.2% 
for children 1-6 and Non-nursing infants, theoretically the most 
exposure population subgroups.
    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 a.i./hectare (ha) post-emergence (1.50 kg a.i./ha). The mean 
annual average EEC was 11.77 part per billion (ppb). It should be noted 
that extensive monitoring data suggests that this estimated 
environmental concentration (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 chronic reference dose (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 4,621. 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 or lawn care operators 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 toxicological endpoint for short-term dermal 
risks is the NOAEL 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).
    3. 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 4,630 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% of the cRfD for the 
U.S. population. EPA generally has no concern for exposures below

[[Page 4475]]

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 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 prenatal and postnatal toxicity and 
the completeness of the database. Based on the current toxicological 
data requirements, the database relative to prenatal and postnatal 
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 0.2% for non-nursing infants and children 1 to 
6 years old, and 0.1% for children 7 to 12 years old. 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-occuptional 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 maximum residue levels 
(MRL's) established for residues of S-metolachlor in or on raw 
agricultural commodities.
[FR Doc. 03-2019 Filed 1-28-03; 8:45 am]
BILLING CODE 6560-50-S