[Federal Register Volume 69, Number 87 (Wednesday, May 5, 2004)]
[Notices]
[Pages 25100-25104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9722]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0063; FRL-7354-8]


Esfenvalerate; 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 pesticide 
petitions 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-2004-0063, must be 
received on or before June 4, 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: Shaja R. Brothers, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; 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. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2004-0063. 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

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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-2004-0063. 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-2004-0063. 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-2004-0063.
    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-2004-0063. 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.

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    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: April 20, 2004.
Betty Shackleford,
Acting 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 Interregional Research Project Number 4 (IR-
4) 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 mateial, 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 Project Number 4 (IR-4)

 PP 0E3912, PP 9E3810, PP 9E3813, PP 9E5075, and PP 9E6061

     EPA has received pesticide petitions PP 0E3912, PP 9E3810, PP 
9E3813, PP 9E5075, and PP 9E6061 from Interregional Research Project 
Number 4 (IR-4), 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 180.533, by establishing tolerances for 
residues of the insecticide, esfenvalerate ((S)-cyano-(3-
phenoxyphenyl)methyl(S)-4-chloro-alpha-(1-methylethyl)benzeneacetate) 
in or on the following raw agricultural commodities:
    1. PP 0E3912 proposes the establishment of a tolerance for cardoon 
at 1.0 part per million (ppm). Registration will be limited to 
California based on the geographical representation of the residue data 
submitted to EPA.
    2. PP 9E3810 proposes the establishment of tolerances for cabbage, 
chinese, bok choy at 1.0 ppm. Registration will be limited to areas 
east of the Mississippi River based on the geographical representation 
of the residue data submitted to EPA.
    3. PP 9E3813 proposes the establishment of a tolerance for sweet 
potato at 0.05 ppm.
    4. PP 9E5075 proposes the establishment of a tolerance for canola, 
seed at 0.3 ppm.
    5. PP 9E6061 proposes the establishment of a tolerance for Brussels 
sprouts at 0.2 ppm for regional registration only.
     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 support granting of the 
petitions. Additional data may be needed before EPA rules on the 
petitions. This notice includes a summary of the petitions prepared by 
DuPont Crop Protection, (formerly DuPont Agricultural products) P.O. 
Box 30, Newark, DE 19714-0030.

A. Residue Chemistry

    1. Plant metabolism. The metabolism and chemical nature of residues 
of fenvalerate in plants are adequately understood. The fate of 
fenvalerate has been extensively studied using radioactive tracers in 
plant metabolism/nature of the residue studies. These studies have 
demonstrated that the parent compound is the only residue of 
toxicological significance. EPA has concluded that the qualitative 
nature of the residue is the same for both fenvalerate and 
esfenvalerate.
    2. Analytical method. There is a practical analytical method 
utilizing electron-capture gas chromatography with nitrogen phosphorous 
detection available for enforcement with a limit of detection that 
allows monitoring of food with residues at or above tolerance levels. 
The limit of detection for updated method is the same as that of the 
current Pesticide Analytical Manual (PAM) II, which is 0.01 ppm.
    3. Magnitude of residues. Fenvalerate is a racemic mixture of four 
isomers about 25% each. Technical Asana the S,S-isomer enriched 
formulation, esfenvalerate, has been the only fenvalerate formulation 
sold in the U.S. for agricultural use. Since the S,S-isomer is the 
insecticidally active isomer, the use rate for Asana is 4 times lower 
than that for pydrin. A petition is pending (PP 4F4329), to convert 
tolerances still to be expressed as the sum of all isomers based on the 
use rates for Asana. Bridging residue studies have shown Asana residues 
to be 3-4 times lower than pydrin residues.
     Field trials were conducted on each commodity (cardoon; cabbage, 
Chinese, bok choy; sweet potato; canola, seed; and brussels sprouts) in 
the requested geographical regions. Results from these trials support 
the proposed tolerances.

B. Toxicological Profile

     An assessment of the toxic effects caused by esfenvalerate is 
discussed in Unit III.A. and Unit III.B. of the Federal Register dated 
March 1, 2001 (66 FR 16926) (FRL-6774-5).
    1. Animal metabolism. In animal studies, after oral dosing with 
radioactive fenvalerate, the majority of the administered radioactivity 
was eliminated in the initial 24-hours. The metabolic pathway involved 
cleavage of the ester linkage followed by hydroxylation, oxidation, and 
conjugation of the acid and alcohol moieties.
    2. Metabolite toxicology. The parent molecule is the only moiety of 
toxicological significance appropriate for regulation in plant and 
animal commodities.

C. Aggregate Exposure

    1. Dietary exposure. Tolerances have been established for the 
residues of fenvalerate/esfenvalerate, in or on a variety of 
agricultural commodities. For purposes of assessing dietary exposure, 
chronic and acute dietary assessments have been conducted using all 
existing tolerances for esfenvalerate. The

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following crops with pending petitions have been included in the 
assessment: Brussels sprouts; cabbage, Chinese, bok choy; canola; 
cardoon; sweet potato, and pistachio. In addition, previously pending 
or intended uses that have been withdrawn leaf lettuce, kale, passion 
fruit are also, included in the dietary exposure assessment.
    i. Food--a. Chronic. A chronic dietary exposure assessment was 
conducted using Novigen's Dietary Exposure Estimate Model 
(DEEMTM). Anticipated residues and adjustment for percent 
crop treated were used in the chronic dietary risk assessment. The 
percentages of the reference dose (RfD) utilized by the most sensitive 
subpopulation, children 1-6 years, was 2.0% based on a daily dietary 
exposure of 0.000134 milligrams/kilogram body weight/day (mg/kg bwt/
day). Chronic exposure for the overall U.S. population was 0.9% of the 
RfD based on a dietary exposure of 0.000058 mg/kg bwt/day. EPA 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.
    b. Acute exposure. Potential acute exposures from food commodities 
were estimated using a Tier 3 (Monte Carlo) Analysis, appropriate 
processing factors for processed food, and distribution analysis. This 
analysis used data from field trial studies and pesticide monitoring 
programs to estimate exposure, and federal and market survey 
information to derive the percent of crop treated. These data are 
considered reliable, and used the upper end estimate of percent crop 
treated in order to not underestimate any significant subpopulation. 
Regional consumption information was taken into account.
    ii. Drinking water. Esfenvalerate is immobile in soil, and will not 
leach into ground water. Due to the insolubility and lipophilic nature 
of esfenvalerate, any residues in surface water will rapidly and 
tightly bind to soil particles and remain with sediment, therefore, not 
contributing to potential dietary exposure from drinking water.
     Surface water concentrations for pyrethroids were estimated using 
PRZM3, and Exposure Analysis Modeling System (EXAMS) using standard EPA 
cotton runoff and Mississippi pond scenarios. The maximum concentration 
predicted in the simulated pond was 0.052 parts per billion (ppb). 
Concentrations in actual drinking water would be much lower than the 
levels predicted in the hypothetical, small, stagnant farm pond model 
since drinking water derived from surface water would be treated before 
consumption.
     Chronic drinking water exposure has been estimated to be 0.000001 
mg/kg/day for both the U.S. general population, and for non-nursing 
infants. Therefore, DuPont believes that there is a reasonable 
certainty of no harm from drinking water.
    2. Non-dietary exposure. Esfenvalerate is registered for non-crop 
uses including spray treatments in and around commercial and 
residential areas, treatments for control of ectoparasites on pets, 
home care products including foggers, pressurized sprays, crack and 
crevice treatments, lawn and garden sprays, and pet and pet bedding 
sprays. For the non-agricultural products, the very low amounts of 
active ingredient they contain, combined with the low vapor pressure 
(1.5 x 10-9 mm Mercury at 25 [deg]C) and low 
dermal penetration, would result in minimal inhalation and dermal 
exposure.
     To assess risk from nonfood short-term and intermediate-term 
exposure, EPA has selected a toxicological endpoint of 2.0 mg/kg/day, 
the NOAEL from the rat and rabbit developmental studies. For dermal 
penetration/absorption, EPA selected 25% dermal absorption based on the 
weight-of-evidence available for structurally related pyrethroids. For 
inhalation exposure, EPA used the oral NOAEL of 2.0 mg/kg/day, and 
assumed 100% absorption by inhalation.
     Individual non-dietary risk exposure analyses were conducted using 
a flea infestation scenario that included pet spray, carpet and room 
treatment, and lawn care, respectively. The total potential short-term 
and intermediate-term aggregate non-dietary exposure including lawn, 
carpet, and pet uses are: 0.000023 mg/kg/day for adults, 0.00129 mg/kg/
day for children 1-6 years old, and 0.00138 mg/kg/day for infants less 
than 1-year old.
     EPA concluded in a final rule published in the Federal Register of 
November 26, 1997 (62 FR 63019) (FRL-5754-6) that the potential non-
dietary exposure for esfenvalerate is associated with substantial 
margins of safety, and that there was reasonable certainty that no harm 
will result from aggregate exposure to esfenvalerate residues.

D. Cumulative Effects

     Section 408 (b)(2)(D)(v) requires that, when considering whether 
to establish, modify, or revoke a tolerance, the Agency consider 
``available information'' concerning the cumulative effects of a 
particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
     EPA does not have at this time available data to determine whether 
esfenvalerate has a common method of toxicity with other substances, or 
how to include this pesticide in a cumulative risk assessment. Unlike 
other pesticides for which EPA has followed a cumulative risk approach 
based on a common mechanism of toxicity, esfenvalerate does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has not assumed that 
esfenvalerate has a common mechanism of toxicity with other substances.

E. Safety Determination

    1. U.S. population. Based on the chronic dietary exposure 
assessment, it is concluded that exposure to esfenvalerate, including 
the proposed uses in food will utilize 0.9% of the RfD for the U.S. 
general population. There is generally 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. The margin of exposure (MOE) for the 
general population was 472 at the 99.9th percentile of 
exposure, based on a daily exposure estimate of 0.004229 mg/kg bwt/day. 
Therefore, there is a reasonable certainty that no harm to the U.S. 
population will result from chronic dietary, acute dietary, non-
dietary, or aggregate exposure to esfenvalerate residues.
    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 effects, and 
the completeness of the toxicity data base. An extra 3X safety factor 
has been assessed for esfenvalerate due to a data gap.
     A chronic dietary exposure assessment found the percentages of the 
RfD utilized by the most sensitive subpopulation to be 2.0% for 
children 1-6 years old based on a dietary exposure of 0.000134 mg/kg 
bwt/day. The most sensitive subpopulation, children 1-6 years, had 
acute dietary MOE of 378 at the 99.9th percentile of 
exposure. Nursing infants had a MOE of 750 at the 99.9th 
percentile of exposure. Non-nursing infants had a MOE of 761 at the 
99.9th percentile of exposure. Therefore, there is a 
reasonable certainty that no harm to infants and children will result 
from chronic dietary, acute

[[Page 25104]]

dietary, non-dietary, or aggregate exposure to esfenvalerate residues.

F. International Tolerances

     Codex maximum residue levels (MRLs) have been established for 
residues of fenvalerate on a number of crops that also have U.S. 
tolerances. There are some minimal differences between the section 408 
tolerances, and certain Codex MRL values for specific commodities. 
These differences could be caused by differences in methods to 
establish tolerances, calculate animal feed, dietary exposure, and as a 
result of different agricultural practices. Therefore, some 
harmonization of these maximum residue levels may be required.
[FR Doc. 04-9722 Filed 5-4-04; 8:45 am]
BILLING CODE 6560-50-S