[Federal Register Volume 70, Number 153 (Wednesday, August 10, 2005)]
[Proposed Rules]
[Pages 46444-46448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15738]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0216; FRL-7729-3]

40 CFR Chapter 1


Fenpyroximate; 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 identification (ID) number OPP-
2005-0216, must be received on or before September 9, 2005.

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 code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 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-2005-0216. 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, 1801 S. Bell St., 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

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electronic public docket and comment system, EPA Dockets. You may use 
EPA Dockets at http://www.epa.gov/edocket/ to submit or review 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 
specific 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 allow 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-2005-0216. 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-2005-0216. 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-2005-0216.
    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, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
number OPP-2005-0216. 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

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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: July 29, 2005.
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). The summary of the petition was 
prepared by Interregional Research Project Number 4 (IR-4), and 
represents the view 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 5E6943

    EPA has received a pesticide petition (5E6943) from Interregional 
Research Project Number 4 (IR-4), 681 U.S. Highway 1 S. 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 part 180.566, by establishing tolerances for residues of 
fenpyroximate in or on the raw agricultural commodities nut, tree, 
group 14 at 0.1 parts per million (ppm); pistachio at 0.1 ppm; almond, 
hulls at 1.8 ppm; fruit, citrus, group 10 at 0.4 ppm; fruit, citrus, 
dried pulp at 2.5 ppm; citrus, oil at 15 ppm; hop at 4.5 ppm; 
peppermint, tops at 3.0 ppm; and spearmint, tops at 3.0 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 that was prepared by Nichino America, Inc., 
4550 New Linden Hill Road, Suite 501, Wilmington, Delaware 19808.

A. Residue Chemistry

    1. Plant metabolism. Fenpyroximate and the Z-isomer are the 
residues of concern for tolerance setting purposes in crops. The 
metabolism of fenpyroximate and its Z-isomer has been studied, and is 
adequately understood.
    2. Analytical method. An enforcement method has been developed 
which involves extraction of fenpyroximate from crops with acetone, 
filtration, partitioning and cleanup, and analysis by gas 
chromatography using a nitrogen/phosphorous detector. This method 
allows detection of residues at or above the proposed tolerances. The 
method has undergone independent laboratory validation as required by 
PR Notices 88-5 and 96-1.
    3. Magnitude of residues. The magnitude of residues for 
fenpyroximate, and the Z-isomer are adequately understood for the 
requested tolerances.

B. Toxicological Profile

    An extensive battery of toxicology studies has been conducted with 
fenpyroximate. EPA has evaluated the available toxicity data and 
considered its validity, completeness, and reliability as well as the 
relationship of the results of the studies to human risk. An assessment 
of toxic effects caused by fenpyroximate, including the toxicological 
endpoints of concern, is discussed in Unit III.A. and Unit III.B. of 
the fenpyroximate final rule published in the June 10, 2004 issue of 
the Federal Register (69 FR 32457) (FRL-7362-9).
    1. Animal metabolism. The qualitative nature of the residues of 
fenpyroximate, Z-isomer, and acid metabolite in animals is adequately 
understood.
    2. Metabolite toxicology. No toxicologically significant 
metabolites were detected in plant or animal metabolism studies for 
citrus, hops, mint, and tree nuts.
    3. Endocrine disruption. Chronic, lifespan, and multi-generational 
bioassays in mammals and acute and subchronic studies on aquatic 
organisms and wildlife did not reveal any endocrine effects for 
fenpyroximate. Any endocrine related effects would have been detected 
in this comprehensive series of required tests. The probability of any 
such effect due to agricultural uses of fenpyroximate is negligible.

C. Aggregate Exposure

    1. Dietary exposure. Tolerances have been established (40 CFR 
180.566) for the combined residues of fenpyroximate and its 
metabolites, in or on a variety of raw agricultural commodities. Acute 
and chronic dietary risk analyses were conducted to estimate the 
potential fenpyroximate and Z-isomer residues in or on the following 
crops: Citrus orange, citrus lemon, citrus grapefruit, citrus oil, mint 
oil, hops, almond, pecans, and pistachio, using modeling based on USDA 
survey data.
    i. Food. The acute dietary exposure was based on the following 
assumptions: Residues at tolerance levels, 100% crop treated, and 
default

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processing factors for all proposed commodities (Tier 1, 95th 
percentile consumption). The chronic dietary exposure was based on the 
following assumptions: Residues at tolerance levels, 100% crop treated, 
using dietary exposure modeling, based on USDA survey data.
    ii. Drinking water. The Agency does not have comprehensive 
monitoring data; therefore, drinking water concentration estimates are 
made by reliance on simulation or modeling taking into account data on 
the physical characteristics of fenpyroximate. The Agency uses the Food 
Quality Protection Act (FQPA) Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS) to produce estimates of pesticide concentrations in an index 
reservoir to predict surface water concentrations. The Screen 
Concentrations in Groundwater (SCI-GROW) model is used to predict 
pesticide concentrations in shallow ground water.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a reference dose (%RfD) or 
population adjusted dose (%PAD). Instead, drinking water levels of 
comparison (DWLOCs) are calculated and used as a point of comparison 
against the model estimates of a pesticide's concentration in water. 
DWLOCs are theoretical upper limits on a pesticide's concentration in 
drinking water in light of total aggregate exposure to a pesticide in 
food, and from residential uses.
    The residue of concern in drinking water was determined to be 
fenpyroximate. There are no established maximum contaminant levels or 
health advisory levels for residues of fenpyroximate in drinking water. 
Laboratory and field data have demonstrated that fenpyroximate is 
immobile in soil and will not leach into ground water. Other data show 
that fenpyroximate is virtually insoluble in water. As a result, EPA 
concluded that residues reaching surface waters from field runoff will 
quickly absorb to sediment particles and be partitioned from the water 
column.
    Estimates of the contribution of the petitioned crops to water 
concentrations were derived. The acute and chronic EEC's in surface 
water calculated by PRZM/EXAMS, Version 3.12, were 1.5 parts per 
billion (ppb), and 0.13 ppb respectively. In ground water, using Tier I 
SCI-GROW (Version 2.3), the estimated EEC was 0.006 ppb.
    2. Non-dietary exposure. The term, residential exposure, is used in 
this document to refer to non-occupational, non-dietary exposure (e.g., 
for lawn and garden pest control, indoor pest control, termiticides, 
and flea and tick control on pets). Fenpyroximate is not registered for 
use on any sites that would result in residential exposure.

D. Cumulative Effects

    A determination has not been made that fenpyroximate has a common 
mechanism of toxicity with other substances. Fenpyroximate does not 
appear to produce a common toxic metabolite with other substances. A 
cumulative risk assessment was not performed for this analysis. Section 
408(b)(2)(D)(v) of FFDCA requires that when considering whether to 
establish, modify, or revoke a tolerance the Agency considers, 
``available information'' concerning the cumulative effects of a 
particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.'' Unlike other pesticides for which EPA 
has followed a cumulative risk approach based on a common mechanism of 
toxicity, EPA has not made a common mechanism of toxicity finding as to 
fenpyroximate and any other substances. Fenpyroximate does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, EPA has not assumed that 
fenpyroximate has a common mechanism of toxicity with other substances. 
For information regarding EPA's efforts to determine which chemicals 
have a common mechanism of toxicity and to evaluate the cumulative 
effects of such chemicals, see the policy statements released by EPA's 
Office of Pesticide Programs (OPP) concerning common mechanism 
determinations and procedures for cumulating effects from substances 
found to have a common mechanism on EPA's Web site at http://www.epa.gov/pesticides/cumulative/.

E. Safety Determination

    1. U.S. population--i. Acute risk. The acute dietary acute 
Population Adjusted Dose (aPAD) was set at 0.05 milligrams/kilogram/day 
(mg/kg/day) for females ages 13-49 years old based on a developmental 
toxicity study in rats that had an oral no observed adverse effect 
level (NOAEL) of 5.0 mg/kg/day. The resulting food exposure estimate 
for this population subgroup was less than 1% of the aPAD. The 
petitioned crops in addition to the registered crop uses accounted for 
less than 6% of the aPAD.
    The addition of these new uses results in a DWLOC of approximately 
1,400 ppb. Surface water concentration estimates increase from 1.5 ppb 
to 1.6 ppb with the added crops. The aggregate exposure will not exceed 
100% of the aPAD.
    ii. Chronic risk. The chronic dietary chronic Population Adjusted 
Dose (cPAD) was determined to be 0.01 mg/kg/day for the general 
population based on an oral NOAEL of 0.97 mg/kg/day in the 2-year rat 
chronic/carcinogenicity study. The Agency determined that exposure from 
currently registered crops utilize 8% of the cPAD. The additional new 
uses will result in a utilization of 10% of the cPAD. Using the 
exposure assumptions previously described, EPA has concluded that 
exposure to fenpyroximate from food, including the additional new uses, 
will utilize 10% of the cPAD for the U.S. population, 21% of the cPAD 
for all infants (<1 year old), and 33% of the cPAD for children (1-2 
years old).
    In addition, there is potential for chronic dietary exposure to 
fenpyroximate in drinking water. The DWLOC for the general population, 
infants (<1 year old) and children (1-6 years old) were 320 ppb, 82 
ppb, and 71 ppb, respectively. Average yearly drinking water 
concentration in surface water was estimated at 0.13 ppb, and 0.006 ppb 
in ground water for both registered and petitioned uses. After 
calculating the DWLOCs and comparing them to the EECs for surface and 
ground water, the aggregate exposure will not exceed 100% of the cPAD.
    2. Infants and children. The Agency confirmed the endpoint 
selection for fenpyroximate and evaluated the potential for increased 
susceptibility of infants and children from exposure to fenpyroximate 
(July 2003). Based on toxicological considerations, the special FQPA 
safety factor was set at 1X when assessing acute and chronic dietary 
exposures.
    3. Aggregate cancer risk for U.S. population. Fenpyroximate is 
classified as not likely to be carcinogenic to humans; therefore, an 
aggregate cancer risk assessment was not performed.
    4. Determination of safety. Based on these risk assessments, EPA 
concluded that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to fenpyroximate residues.

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F. International Tolerances

    Codex MRLs have been established for residues of fenpyroximate and 
Z-isomer on hops in Germany at 10 ppm.

[FR Doc. 05-15738 Filed 8-9-05; 8:45 am]
BILLING CODE 6560-50-M