[Federal Register Volume 68, Number 98 (Wednesday, May 21, 2003)]
[Notices]
[Pages 27799-27802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12485]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0142; FRL-7308-4]


Fenhexamid; Notice of Filing Pesticide Petitions 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 pesticide 
petitions proposing the establishment of regulations for residues of a 
certain

[[Page 27800]]

pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket ID number OPP-2003-0142, must be 
received on or before June 20, 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: Sidney Jackson, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (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. 
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. 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. 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-2003-0142. 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 EPA's 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 EPA's 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

[[Page 27801]]

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-2003-0142. 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-2003-0142. 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-2003-0142.
    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-2003-0142. 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 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 the 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: May 9, 2003.
 Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petitions

    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 the Arvesta Corporation, 100 First Street, 
Suite 1700, San Francisco, CA 94105 and represents the view of Arvesta 
Corporation. The petitions 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 Project Number 4

PP 2E6463, 2E6496, 3E6532, and 3E6541

    EPA has received pesticide petitions 2E6463, 2E6496, 3E6532, and 
3E6541, from the Interregional Research Project Number 4 (IR-4), Center 
for Minor Crop Pest Management, Rutgers, The State University of New 
Jersey, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-
3390 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 
346a(d), to amend 40 CFR 180.553 by establishing tolerances for 
residues of fenhexamid, N-(2,3-dichloro-4-hydroxyphenyl)-1-methyl-
cyclohexane carboxamide, in or on raw agricultural commodities as 
follows:
    1. PP 2E6463 proposes a tolerance in or on kiwifruit (post harvest) 
at 15.0 parts per million (ppm).
    2. PP 2E6496 proposes to establish tolerances in or on cucumber at 
2.0 ppm, and vegetable, fruiting, group 8 at 2.0 ppm.
    3. PP 3E6532 proposes a tolerance in or on leafy greens subgroup 
4A, except spinach, at 30.0 ppm.
    4. PP 3E6541 proposes a tolerance in or on fruit, stone, group 12 
(post harvest) at 10 ppm.
    This action also proposes to further amend 40 CFR 180.553 by 
deleting the

[[Page 27802]]

entry for stone fruit, except plum (fresh prune) tolerance at 6.0 ppm 
as a higher tolerance of 10 ppm for fruit, stone, group 12 (post 
harvest) is proposed herein.

A. Residue Chemistry

    1. Plant metabolism. The qualitative nature of fenhexamid residues 
in plants is adequately understood.
    2. Analytical method. An adequate method for purposes of 
enforcement of the proposed fenhexamid tolerances in plant commodities 
is available.
    3. Magnitude of residues. The magnitude of residues for fenhexamid 
on the proposed commodities is adequately understood.

B. Toxicological Profile

    In the Federal Register of February 8, 2002 (67 FR 6028) (FRL-6821-
2), EPA published the Notice of Filing proposing the establishment of 
tolerances for residues of fenhexamid on a number of raw agricultural 
commodities, including caneberry, et. al. That publication summarizes 
in detail the current state of knowledge regarding the toxicological 
profile of fenhexamid including aggregate exposure assessment and 
determination of safety. Interested readers are referred to that 
document for specific information under Unit II.

C. Aggregate Exposure

    1. Dietary exposure--i. Food. Dietary exposure to fenhexamid is 
limited to the established tolerances for residues of fenhexamid on 
grapes (at 4.0 ppm), raisins (at 6.0 ppm), strawberries (at 3.0 ppm), 
almond nutmeat (at 0.02 ppm), almond hulls (at 2.0 ppm), stonefruit 
(pre-harvest, at 5.0 ppm), pear (at 15 ppm), bushberries (at 5.0 ppm), 
caneberries (at 20 ppm), and pistachios (at 0.02 ppm); the proposed 
tolerances in the current submission which are as follows: Cucumber (at 
2.0 ppm), crop group 8 (fruiting vegetables, at 2.0 ppm), kiwi (post-
harvest, at 15.0 ppm), lettuce (at 30.0 ppm), and crop group 12 
(stonefruit, pre-harvest and post-harvest, at 10.0 ppm).
    ii. Drinking water. Review of the environmental fate data indicates 
that fenhexamid is relatively immobile and rapidly degrades in the soil 
and water. Fenhexamid dissipates in the environment via several 
processes. Therefore, Arvesta Corporation believes that a significant 
contribution to aggregate risk from fenhexamid in drinking water is 
unlikely.
    2. Non-dietary exposure. There is no significant potential for non-
occupational exposure to the general public. The proposed uses are 
limited to agricultural and horticultural use.

D. Cumulative Effects

    Consideration of a common mechanism of toxicity is not appropriate 
at this time since it has a unique mode of action. Moreover, there is 
no significant toxicity observed for fenhexamid. Even at toxicology 
limit doses, only minimal toxicity is observed for fenhexamid. 
Therefore, Arvesta Corporation concludes that only the potential risks 
of fenhexamid are considered in the exposure assessment.

E. Safety Determination

    1. U.S. population. Considering that the percent of the chronic 
population adjusted dose (cPAD) utilized by all current uses (almonds, 
bushberries, caneberries, grapes, pear, pistachios, raisins, pre-
harvest stonefruit, and strawberry) is estimated to be 7% in the 
Federal Register of April 18, 2002 (67 FR 19114) (FRL-6829-9); 
considering also the proposed tolerances, proportion of the crops 
treated and their importance in the diet, the percent of the cPAD 
utilized by the proposed uses is estimated to 14%. Therefore, Arvesta 
Corporation believes that the estimates of dietary exposure indicate 
adequate safety margins for the overall U.S. population.
    2. Infants and children. Considering that the percent of the cPAD 
utilized by all current uses (almonds, bushberries, caneberries, 
grapes, pear, pistachios, raisins, pre-harvest stonefruit, and 
strawberry) is estimated to be 66% (infants) and 17% (children) (67 FR 
19114, April 18, 2002); considering also the proposed tolerances, 
proportion of the crops treated and their importance in the diet, the 
percent of the cPAD utilized by the proposed uses is estimated to 11% 
(infants) and 13% (children). Therefore, the estimates of dietary 
exposure indicate adequate safety margins for children. In assessing 
the potential for additional sensitivity of infants and children to 
residues of fenhexamid, the available developmental toxicity and 
reproductive toxicity studies and the potential for endocrine 
modulation by fenhexamid were considered. Developmental toxicity 
studies in two species indicate that fenhexamid does not impose 
additional risks to developing fetuses and is not a teratogen. The 2-
generation reproduction study in rats demonstrated that there were no 
adverse effects on reproductive performance, fertility, fecundity, pup 
survival, or pup development at non-maternally toxic levels. Maternal 
and developmental no observed adverse effect levels (NOAELs) and lowest 
observed adverse effect levels (LOAELs) were comparable, indicating no 
increase in susceptibility of developing organisms. No evidence of 
endocrine effects was noted in any study. It is therefore concluded by 
Arvesta Corporation that fenhexamid poses no additional risk for 
infants and children and no additional uncertainty factor is warranted.

F. International Tolerances

    International tomato tolerances are in effect in France, Germany, 
Greece, Italy, Slovenia, Spain, Turkey (1 ppm), and other European 
countries (2 ppm). Kiwi tolerances are as follows: Greece, Italy, and 
Slovenia (10 ppm). Stonefruit tolerances already exist in the U.S. for 
pre-harvest applications as well as in Canada (6 ppm), Austria (cherry, 
5 ppm; plum, 2 ppm); Belgium (cherry, 5 ppm); Germany and Slovenia 
(cherry, 5 ppm; peach and plum, 2 ppm), Italy (cherry, 5 ppm; apricot, 
peach, and plum 2 ppm); Japan (peach, 1 ppm), Switzerland (cherry, 2 
ppm) and the United Kingdom (plum, 1 ppm), and other European countries 
(peach and plum, 1 ppm; cherry, 5 ppm).
[FR Doc. 03-12485 Filed 5-20-03; 8:45 am]
BILLING CODE 6560-60-50-S