[Federal Register Volume 69, Number 156 (Friday, August 13, 2004)]
[Notices]
[Pages 50196-50199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18553]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0157; FRL-7371-7]


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-2004-0157, must be 
received on or before September 13, 2004

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: Sidney Jackson, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number:

[[Page 50197]]

(703) 305-7610; 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:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     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. EPA Docket. EPA has established an official public docket for 
this action under docket ID number OPP-2004-0157. 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 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-2004-0157. 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.

[[Page 50198]]

    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID number OPP-2004-0157. 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-2004-0157.
    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-2004-0157. 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 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: August 4, 2004.
Lois Rossi
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner's summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3), except in this notice, the full 
text of the petition summary is incorporated by reference. The summary 
of the petition was prepared by the petitioner and represents the view 
of the petitioner. The summary may have been edited by EPA if the 
terminology used was unclear, the summary contained extraneous 
material, or the summary unintentionally made the reader conclude that 
the findings reflected EPA's position and not the position of the 
petitioner. 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.

Interregional Research Number 4 (IR-4)

PP 3E6787

    EPA has received a pesticide petition (3E6787) from IR-4, 681 U.S. 
Highway 1 South, North Brunswick, NJ 08902-3390 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 180.368(a)(2) by 
establishing tolerances for combined residues (free and bound) 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 and 4-(2-ethyl-
6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, each expressed as 
the parent compound, S-metolachlor, in or on the following raw 
agricultural commodities (RACs):
    1. Brassica, head and stem, subgroup 5A at 0.5 parts per million 
(ppm).
    2. Cattle, fat at 0.04 ppm; cattle, kidney at 0.20 ppm; cattle, 
meat at 0.04 ppm; cattle, meat byproducts, except kidney at 0.04 ppm.
    3. Corn, field, grain at 0.10 ppm; corn, field, stover at 6.0 ppm; 
corn, field, forage at 6.0 ppm; corn, sweet, forage at 6.0 ppm; corn, 
sweet, stover at 6.0 ppm; corn, pop, stover at 6.0 ppm; corn, pop, 
grain at 6.0 ppm; corn, sweet, kernel plus cob with husk removed at 0.1 
ppm.
    4. Cotton, gin byproducts at 4.0 ppm; cotton, undelinted seed at 
0.1 ppm.
    5. Egg at 0.04 ppm.
    6. Garlic, bulb at 0.1 ppm.

[[Page 50199]]

    7. Goat, fat at 0.04 ppm; goat, kidney at 0.20 ppm; goat, meat at 
0.04 ppm; goat, meat byproducts, except kidney at 0.04 ppm.
    8. Horse, fat at 0.04 ppm; horse, kidney at 0.20 ppm; horse, meat 
at 0.04 ppm; Horse, meat byproducts, except kidney at 0.04 ppm.
    9. Leaf petioles subgroup 4B at 0.10 ppm.
    10. Milk at 0.02 ppm.
    11. Onion, dry bulb at 0.1 ppm; onion, green at 2.0 ppm.
    12. Pea and bean, dried shelled, except soybean, subgroup 6C at 0.1 
ppm.
    13. Peanut at 0.2 ppm; peanut, hay at 20 ppm; peanut, meal at 0.40.
    14. Poultry, fat at 0.04 ppm; poultry, meat at 0.04 ppm; poultry, 
meat byproducts, except liver at 0.04 ppm.
    15. Safflower, seed at 0.1 ppm.
    16. Shallot at 0.1 ppm.
    17. Sheep, fat at 0.04 ppm; sheep, kidney at 0.20 ppm; sheep, meat 
at 0.04 ppm; sheep, meat byproducts, except kidney at 0.04 ppm.
    18. Sorghum grain, stover at 4.0 ppm; sorghum grain, forage at 1.0 
ppm; sorghum grain, grain at 0.3 ppm.
    19. Soybean, seed at 0.2 ppm; soybean, forage at 5.0 ppm; soybean, 
hay at 8.0 ppm.
    20. Vegetable, foliage of legume, except soybean, subgroup 7A at 15 
ppm.
    21. Vegetable, fruiting, group 8 at 0.5 ppm.
    22. Vegetable, legume, edible podded, subgroup 6A at 0.5 ppm.
    23. Vegetable, root, except sugar beet, subgroup 1B at 0.3 ppm.
    24. Vegetable, tuberous and corm, subgroup 1C at 0.2 ppm.
    IR-4 proposes to amend 40 CFR 180.368(a)(2) by removing tolerances 
established for the combined residues (free and bound) 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 and 4-(2-ethyl-
6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, each expressed as 
the parent compound, S-metolachlor, in or on the following RACs: 
Carrot, roots at 0.20 ppm; horseradish at 0.20 ppm; onion, green at 
0.20; rhubarb at 0.10 ppm; Swiss chard at 0.10 ppm; celery at 0.10 ppm; 
and tomato at 0.1 ppm.
    IR-4 also proposes, upon approval of the aforementioned tolerances, 
to amend 40 CFR 180.368(b)(2) by deleting the time-limited tolerance 
for the combined residues (free and bound) of the herbicide S-
metolachlor [(S)-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl) acetamide], its R-enantiomer and its metabolites, 
determined as the derivatives, 2-(2-ethyl-6-methylphenyl)amino-1-
propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-
morpholinone, each expressed as the parent compound, in or on the RAC 
sweet potato, roots at 0.2 ppm.
    Additionally, IR-4 proposes to amend 40 CFR 180.368(d) by 
establishing tolerances for combined residues (free and bound) 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 and 4-(2-
ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, each expressed 
as the parent compound, S-metolachlor, in or on the following RACs:
    1. Animal feed, nongrass, group 18 at 1.0 ppm.
    2. Barley, grain at 0.1 ppm; barley straw at 0.1 ppm.
    3. Buckwheat, grain at 0.1 ppm.
    4. Oat, forage at 0.5 ppm; oat, grain at 0.1 ppm; oat straw at 0.5 
ppm.
    5. Peanut, meal at 0.4 ppm.
    6. Rice, grain at 0.1 ppm; rice, straw at 0.5 ppm.
    7. Rye, forage at 0.5 ppm; rye, grain at 0.1 ppm; rye straw at 0.5 
ppm.
    8. Wheat, forage at 0.5 ppm; wheat grain at 0.1 ppm; wheat straw at 
0.5 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 support granting of the petition. 
Additional data may be needed before EPA rules on the petition. This 
notice includes a summary of the petition prepared by the registrant, 
Syngenta Crop Protection, 410 Swing Road, Greensboro, NC 27419. For a 
detailed discusssion of the petitioner's synopsis of the science 
findings from environmental and human health assessments of this 
agricultural pesticide, please refer to theFederal Register of August 
13, 2003 (68 FR 48373) (FRL-7320-9), ``S-Metolachlor; Notice of Filing 
a Pesticide Petition to Establish a Tolerance for a Certain Pesticide 
Chemical in or on Food.''
[FR Doc. 04-18553 Filed 8-12-04; 8:45 am]
BILLING CODE 6560-50-S