[Federal Register Volume 68, Number 45 (Friday, March 7, 2003)]
[Notices]
[Pages 11093-11096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5315]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0025; FRL-7289-8]


Pyriproxyfen; 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.

-----------------------------------------------------------------------

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-2003-0025, must be 
received on or before April 7, 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: 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:
    [sbull] Crop producers (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. 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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions. 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-2003-0025. 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 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

[[Page 11094]]

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-2003-0025. 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-2003-0025. 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-2003-0025.
    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-2003-0025. 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: January 30, 2003.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

 Summaries of Petitions

    The petitioner summaries of the pesticide petitions are printed 
below as required by FFDCA section 408(d)(3). The summaries of the 
petitions were prepared by the petitioners and represent the views of 
the petitioners. The petition summary announces the availability of a 
description of the analytical methods available to EPA for the 
detection and measurement of the pesticide chemical residues or an 
explanation of why no such method is needed.

Interregional Research Project Number IR-4

 2E6416, 2E6425, 2E6428, and 2E6436

    EPA has received pesticide petitions (2E6416, 2E6425, 2E6428, and 
2E6436) from the Interregional Research Project Number IR-4, 681 U.S. 
Highway 1 South, North Brunswick, NJ 08902

[[Page 11095]]

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 180.510 by 
establishing tolerances for residues of pyriproxyfen, 2-[1-methyl-2-4-
phenoxyphenoxy)ethoxypyridine] in or on the following raw agricultural 
commodities:
    1. PP 2E6416 proposes the establishment of tolerances for atemoya, 
biriba, cherimoya, custard apple, ilama, soursop, and sugar apple at 
0.20 parts per million ppm (ppm).
    2. PP 2E6425 proposes the establishment of tolerances for fig at 
0.30 ppm, and fig, dried at .1 ppm.
    3. PP 2E6428 proposes the establishment of tolerances for avocado, 
black sapote, canistel, mamey sapote, mango, papaya, sapodilla, and 
star apple at 1.0 ppm.
    4. PP 2E6436 proposes the establishment of a tolerance for okra at 
0.02 ppm.
    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 
Valent USA Corporation.

A. Residue Chemistry

    1. Plant metabolism. The major metabolic pathways in plants is aryl 
hydroxylation and cleavage of the ether linkage, followed by further 
metabolism into more polar products by further oxidation and/or 
conjugation reactions. However, the bulk of the radiochemical residue 
on raw agricultural commodities samples remained as parent. Comparing 
metabolites detected and quantified from cotton, apple, tomato, goat, 
hen, and rat shows that there are no significant aglycones in plants 
which are not also present in the excreta or tissues of animals. The 
residue of concern is best defined as the parent, pyriproxyfen.
    2. Analytical method. The extraction methodology has been validated 
using aged radiochemical residue samples from metabolism studies. The 
methods have been validated in cottonseed, apples, soil, and oranges at 
independent laboratories. EPA has successfully validated the analytical 
methods for analysis of cottonseed, pome fruit, nutmeats, almond hulls, 
and fruiting vegetables. The limit of detection of pyriproxyfen in the 
methods is 0.01 ppm which will allow monitoring of food with residues 
at the levels proposed for the tolerances.
    3. Magnitude of residues. The magnitude of residues for 
pyriproxyfen is adequately understood for the proposed commodities.

B. Toxicological Profile

    1. Acute toxicity. An assessment of toxic effects caused by 
pyriproxyfen is discussed in Unit II.B. of the Federal Register dated 
April 4, 2001 (FRL-6772-4) (66 FR 17883).
    2. Animal metabolism. The absorption, tissue distribution, 
metabolism and excretion of 14C-labeled pyriproxyfen were 
studied in rats after single oral doses of 2 or 1,000 milligrams/
kilograms body weight (mg/kg/bwt) (phenoxyphenyl and pyridyl label), 
and after a single oral dose of 2 mg/kg/bwt, phenoxyphenyl label only, 
following 14 daily oral doses at 2 mg/kg/bwt of unlabelled material. 
For all dose groups, most 88-96%) of the administered radiolabel was 
excreted in the urine and feces within 2 days after radiolabeled test 
material dosing, and 92-98% of the administered dose was excreted 
within 7 days. Seven days after dosing, tissue residues were generally 
low, accounting for no more than 0.3% of the dosed 14C. 
Radiocarbon concentrations in fat were the higher than in other tissues 
analyzed. Recovery in tissues over time indicates that the potential 
for bioaccumulation is minimal. There were no significant sex or dose-
related differences in excretion or metabolism.
    3. Metabolite toxicology. The potential for chronic toxicity is 
adequately tested by chronic exposure to the parent at the maximum 
tolerated dose and consequent chronic exposure to the internally formed 
metabolites. Seven metabolites of pyriproxyfen, 4'-OH-pyriproxyfen, 5'-
OH-pyriproxyfen, desphenyl-pyriproxyfen, POPA, PYPAC, 2-OH-pyridine and 
2,5-diOH-pyridine, have been tested for mutagenicity, via Ames assay, 
and acute oral toxicity to mice. All seven metabolites were tested in 
the Ames assay with and without S9 at doses up to 5,000 micrograms per 
plate or up to the growth inhibitory dose. The metabolites did not 
induce any significant increases in revertible colonies in any of the 
test strains. Positive control chemicals showed marked increases in 
reverting colonies.
    The acute toxicity to mice of 4'-OH-pyriproxyfen, 5'-OH-
pyriproxyfen, desphenyl-pyriproxyfen, POPA, and PYPAC did not appear to 
markedly differ from pyriproxyfen, with all metabolites having acute 
oral lethal dose (LD50) values greater than 2,000 mg/kg/bwt. 
The two pyridines, 2-OH-pyridine and 2,5-diOH-pyridine, gave acute oral 
LD50 values of 124 (male) and 166 (female) mg/kg/bwt, and 
1,105 (male) and 1,000 (female) mg/kg/bwt, respectively.
    4. Endocrine disruption. While specific tests, uniquely designed to 
evaluate the potential effects of pyriproxyfen on mammalian endocrine 
systems have not been conducted, the toxicology of pyriproxyfen has 
been extensively evaluated in acute, sub-chronic, chronic, 
developmental, and reproductive toxicology studies including detailed 
histopathology of numerous tissues. The results of these studies show 
no evidence of any endocrine-mediated effects and no pathology of the 
endocrine organs. Consequently, Valent concludes that pyriproxyfen does 
not possess estrogenic or endocrine disrupting properties applicable to 
mammals.

C. Aggregate Exposure

    1. Dietary exposure--i. Food. An evaluation of chronic dietary 
exposure including both food and drinking water has been performed for 
the U.S. population and various sub-populations including infants and 
children. No acute dietary endpoint and dose was identified in the 
toxicology data base for pyriproxyfen, therefore, the Valent 
Corporation concludes that there is a reasonable certainty of no harm 
from acute dietary exposure.
    Chronic dietary exposure to pyriproxyfen residues was calculated 
for the U.S. population and 25 population subgroups assuming tolerance 
level residues, processing factors from residue studies, and 100% of 
the crop-treated. The analyses included residue data for all existing 
uses, pending uses, and proposed new uses.
    ii. Drinking water. Since pyriproxyfen is applied outdoors to 
growing agricultural crops, the potential exists for pyriproxyfen or 
its metabolites to reach ground water or surface water that may be used 
for drinking water. Because of the physical properties of pyriproxyfen, 
it is unlikely that pyriproxyfen or its metabolites can leach to 
potable ground water. To quantify potential exposure from drinking 
water, surface water concentrations for pyriproxyfen were estimated 
using Generic Expected Environmental Concentration (GENEEC) 1.3.
    2. Non-dietary exposure. Pyriproxyfen is currently registered for 
use on residential non-food sites. Pyriproxyfen is the active 
ingredient in numerous registered products for flea and tick control. 
Formulations include foggers,

[[Page 11096]]

aerosol sprays, emulsifiable concentrates, and impregnated materials 
(pet collars). With the exception of the pet collar uses, consumer use 
of pyriproxyfen typically results in acute and short-term intermittent 
exposures.

D. Cumulative Effects

    There are no other pesticidal compounds that are structurally 
related to pyriproxyfen and have similar effects on animals. In 
consideration of potential cumulative effects of pyriproxyfen and other 
substances that may have a common mechanism of toxicity, there are 
currently no available data or other reliable information indicating 
that any toxic effects produced by pyriproxyfen would be cumulative 
with those of other chemical compounds. Thus, only the potential risks 
of pyriproxyfen have been considered in this assessment of aggregate 
exposure and effects. Valent will submit information for EPA to 
consider concerning potential cumulative effects of pyriproxyfen 
consistent with the schedule established by EPA at (62 FR 42020 August 
4, 1997) and other subsequent EPA publications pursuant to the Food 
Quality Protection Act.

E. Safety Determination

    1. U.S. population. Chronic exposure to the overall U.S. population 
is estimated to be 0.002984 mg/kg/bwt day, representing 0.9% of the 
Reference Dose (RfD). The results of the chronic dietary exposure 
assessment demonstrate that estimates of chronic dietary exposure for 
all existing, pending and proposed uses of pyriproxyfen are well below 
the chronic RfD of 0.35 mg/kg/bwt day. The estimated chronic dietary 
exposure from food for the overall U.S. population and many non-child/
infant subgroups is from 0.002123 to 0.003884 mg/kg/bwt day, 0.607 to 
1.100% of the RfD. Generally, the Agency has no cause for concern if 
total residue contribution is less than 100% of the RfD. Valent 
concludes that there is a reasonable certainty that no harm will result 
to the overall U.S. population or any non-child/infant subgroups from 
aggregate, chronic dietary exposure to pyriproxyfen residues.
    2. Infants and children--i. Safety factor for infants and children. 
In assessing the potential for additional sensitivity of infants and 
children to residues of pyriproxyfen, FFDCA section 408 provides that 
EPA shall apply an additional margin of safety, up to 10-fold, for 
added protection for infants and children in the case of threshold 
effects unless EPA determines that a different margin of safety will be 
safe for infants and children.
    The toxicological data base for evaluating prenatal and postnatal 
toxicity for pyriproxyfen is complete with respect to current data 
requirements. There are no special prenatal or postnatal toxicity 
concerns for infants and children, based on the results of the rat and 
rabbit developmental toxicity studies or the 2-generation reproductive 
toxicity study in rats. Valent concludes that reliable data support use 
of the standard 100-fold uncertainty factor and that an additional 
uncertainty factor is not needed for pyriproxyfen to be further 
protective of infants and children.
    ii. Chronic dietary exposure and risk infants and children. For the 
most highly exposed sub-population, children 1 to 6 years of age, 
exposure is calculated to be 0.007438 mg/kg/bwt day, or 2.1% of the 
RfD. Using the conservative exposure assumptions, the percentage of the 
RfD that will be utilized by chronic dietary (food only) exposure to 
residues of pyriproxyfen ranges from 0.002601 mg/kg/bwt day for nursing 
infants, up to 0.007438 mg/kg/bwt day for children (1 to 6 years of 
age), 0.743 to 2.125% of the RfD, respectively. EPA generally has no 
concern for exposures below 100% of the RfD because the RfD represents 
the level at or below which daily aggregate dietary exposure over a 
lifetime will not pose appreciable risks to human health. Valent 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from aggregate, chronic dietary exposure to 
pyriproxyfen residues.
    iii. Drinking water. The average 56-day concentration predicted in 
the simulated pond water was 0.16 parts per billion (ppb). Using 
standard assumptions about body weight and water consumption, the 
chronic exposure to pyriproxyfen from this drinking water would be 4.57 
x 10-6 and 1.6 x 10-5 mg/kg/bwt day for adults 
and children, respectively; 0.0046% of the RfD 0.35 mg/kg/day for 
children. Based on this worse case analysis, the contribution of water 
to the dietary risk is negligible.
    iv. Non-dietary exposure. Chronic residential post-application 
exposure and risk assessments were conducted to estimate the potential 
risks from pet collar uses. The risk assessment was conducted using the 
following assumptions: Application rate of 0.58 mg active ingredient 
day, average body weight for a 1-6 year old child of 10 kg, the active 
ingredient dissipates uniformly through 365 days the label instruct to 
change collar (once a year), 1% of the active ingredient is available 
for dermal and inhalation exposure per day assumption from Draft EPA 
Standard Operating Procedures (SOPs) for Residential Exposure 
Assessments (December 18, 1997). The assessment also assumes an 
absorption rate of 100%. This is a conservative assumption since the 
dermal absorption was estimated to be 10%. The estimated chronic term 
margin of exposure (MOE) was 61,000 for children, and 430,000 for 
adults. The risk estimates indicate that potential risks from pet 
collar uses do not exceed the Agency's level of concern.

F. International Tolerances

    There are no presently existing Codex maximum residue levels for 
pyriproxyfen.
[FR Doc. 03-5315 Filed 3-6-03; 8:45 am]
BILLING CODE 6560-50-S