[Federal Register Volume 70, Number 158 (Wednesday, August 17, 2005)]
[Notices]
[Pages 48413-48417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16301]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0234; FRL-7732-1]


Pyriproxyfen; 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 identification (ID) number OPP-
2005-0234, must be received on or before September 16, 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: Barbara Madden, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; 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 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-2005-0234. 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 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, to 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

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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.1. 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-2005-0234. 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-2005-0234. 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-2005-0234.
    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-2005-0234. 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.

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    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

     EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in FFDCA section 408(d)(2); however, 
EPA has not fully evaluated the sufficiency of the submitted data at 
this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

     Environmental protection, Agricultural commodities, Feed 
additives, Food additives, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 11, 2005.
Lois Rossi,
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 Interregional Research Project Number 4 (IR-
4), and represents the view of the petitioner. The petion summary 
announces the availabilty 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

 PP 3E6582, PP 3E6596, PP 3E6750, PP 4E6865, PP 4E6866

     EPA has received pesticide petitions (PP) 3E6582, 3E6596, 3E6750, 
4E6865, and 4E6866 from the Interregional Research Project Number 4 IR-
4, Technology Center of New Jersey, Rutgers, the State University of 
New Jersey, 681 U.S. Highway 1 S., North Brunswick, NJ 08902-
3390 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 
346a(d), to amend 40 CFR part 180 by establishing tolerances for 
residues of pyriproxyfen, 2-[1-methyl-2-(4-phenoxyphenoxy) 
ethoxy]pyridine, in or on raw agricultural commodities as follows:
    1. PP 3E6582 proposes a tolerance for white sapote and Ugli fruit 
at 0.3 parts per million (ppm).
    2. PP 3E6596 proposes a tolerance for legume vegetables, crop 
subgroups 6a, 6b, and 6c at 0.2 ppm.
    3. PP 3E6750 proposes a tolerance for onion, dry bulb at 0.05 ppm.
    4. PP 4E6865 proposes a tolerance for strawberry at 0.3 ppm.
    5. PP 4E6866 proposes a tolerance for grape at 2.5 ppm and raisin 
at 4.0 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.

A. Residue Chemistry

    1. Plant and animal metabolism. Metabolism of 14C-
pyriproxyfen labeled in the phenoxyphenyl ring and in the pyridyl ring 
has been studied in cotton, apples, tomatoes, lactating goats, laying 
hens, and rats. 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 (RAC) 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.
     Ruminant and poultry metabolism studies demonstrated that transfer 
of administered 14C-residues to tissues was low. Total 
14C-residues in goat milk, muscle and tissues accounted for 
less than 2% of the administered dose, and were less than 1 part per 
million (ppm) in all cases. In poultry, total 14C-residues 
in eggs, muscle and tissues accounted for about 2.7% of the 
administered dose, and were less than 1 ppm in all cases except for 
gizzard.
    2. Analytical method. Practical analytical methods for detecting 
and measuring levels of pyriproxyfen (and relevant metabolites) have 
been developed and validated in or on all appropriate agricultural 
commodities, respective processing fractions, milk, animal tissues, and 
environmental samples. 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. Residue data were generated with 
pyriproxyfen for tolerance setting and dietary exposure estimates. 
Adequate residue trials were performed with pyriproxyfen to support the 
uses described in this notice of filing.

B. Toxicological Profile

     An assessment of toxic effects caused by pyriproxyfen is discussed 
in Unit III.A. and Unit III.B. of the Federal Register of April 4, 
2001, (66 FR 17883) (FRL-6772-4).
    1. 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 unlabeled material. For 
all dose groups, most (-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 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.
    2. Metabolite toxicology. Metabolism studies of pyriproxyfen in 
rats, goats and hens, as well as the fish bioaccumulation study 
demonstrate that the parent is very rapidly metabolized and eliminated. 
In the rat, most (88-96%) of the administered radiolabel was excreted 
in the urine and feces within 2 days of dosing, and 92-98% of the 
administered dose was excreted within 7 days. Tissue residues were low 
7 days after dosing, accounting for no more than 0.3% of the dosed 
14C. Because parent and metabolites are not retained

[[Page 48416]]

in the body, the potential for acute toxicity from in situ formed 
metabolites is low. The potential for chronic toxicity is adequately 
tested by chronic exposure to the parent at the maximum tolerated dose 
(MTD) 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 micro-grams 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.
    3. Endocrine disruption. Pyriproxyfen is specifically designed to 
be an insect growth regulator and is known to produce juvenoid effects 
on arthropod development. However, this mechanism-of-action in target 
insects and some other arthropods has no relevance to any mammalian 
endocrine system. 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, it is concluded that pyriproxyfen does not 
possess estrogenic or endocrine disrupting properties applicable to 
mammals.

C. Aggregate Exposure

    1. Dietary exposure. 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, Valent Corporation concludes 
that, there is a reasonable certainty of no harm from acute dietary 
exposure.
    i. Food. Chronic dietary exposure to pyriproxyfen residues was 
calculated for the U.S. population and 16 population subgroups assuming 
tolerance level residues, processing factors from residue studies, and 
assuming 100% of the crop will be treated with pyriproxyfen. The 
analyses included residue data for all existing uses, pending uses, and 
proposed new uses. The results from several representative subgroups 
are listed below. Chronic dietary exposure to the overall U.S. 
population is estimated to be 0.0238 mg/kg bwt/day, representing 6.8% 
of the reference dose (RfD). For the most highly exposed sub-
population, infants, <1 years of age, dietary exposure is calculated to 
be 0.0245 mg/kg bwt/day, or 7.0% of the RfD. Generally speaking, the 
Agency has no cause for concern if total residue contribution for 
established and proposed tolerances is less than 100% of the RfD.
    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). The 
residue levels in drinking water are the peak chronic residue level as 
estimated by GENEEC. Using standard assumptions about body weight and 
water consumption, the chronic exposure to pyriproxyfen from this 
drinking water would be 0.00009 mg/kg bwt/day for adults and ``0'' year 
infants, and represent 0.025% of the RfD (0.35 mg/kg/day). Based on 
this worse case analysis, the contribution of water to the dietary risk 
is negligible.
    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, 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. No 
acute dermal, or inhalation dose or endpoint was identified in the 
toxicity data for pyriproxyfen. Similarly, doses and endpoints were not 
identified for short-term and intermediate-term dermal or inhalation 
exposure to pyriproxyfen. The Agency has concluded that there are 
reasonable certainties of no harm from acute, short-term, and 
intermediate-term dermal and inhalation occupational and residential 
exposures due to the lack of significant toxicological effects 
observed.
     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 (a.i.)/day, average body 
weight for a 1-6 year old child of 10 kg, the a.i. dissipates uniformly 
through 365 days (the label instructs to change the 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 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.

D. Cumulative Effects

     Section 408(b)(2)(D)(v) requires that the Agency must consider 
``available information'' concerning the cumulative effects of a 
particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.'' Available information in this context 
include not only toxicity, chemistry, and exposure data, but also, 
scientific policies and methodologies for understanding common 
mechanisms of toxicity and conducting cumulative risk assessments. For 
most pesticides, although, the Agency has some information in its files 
that may turn out to be helpful in eventually determining whether a 
pesticide shares a common mechanism of toxicity with any other 
substances, EPA does not at this time have the methodologies to resolve 
the complex scientific issues concerning common mechanism of toxicity 
in a meaningful way.
     There are no other pesticidal compounds that are structurally 
related to pyriproxyfen and have similar effects on animals. In 
consideration of potential

[[Page 48417]]

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.

E. Safety Determination

    1. U.S. population--i. Chronic dietary exposure and risk to adult 
sub-populations. The results of the chronic dietary exposure assessment 
described above 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/day. The estimated chronic dietary 
exposure from food for the overall U.S. population and many non-child/
infant subgroups is from 0.006 to 0.0245 mg/kg bwt/day, 1.7 to 7.0% of 
the RfD. Addition of the small but worse case potential chronic 
exposure from drinking water (calculated above) increases exposure by 
only 0.00002 mg/kg bwt/day and does not change the maximum occupancy of 
the RfD significantly. Generally, the Agency has no cause for concern 
if total residue contribution is less than 100% of the RfD. It can be 
concluded 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.
    ii. Acute dietary exposure and risk to adult sub-populations. No 
acute dietary endpoint and dose were identified in the toxicology data 
base for pyriproxyfen; therefore, it can be concluded 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, acute 
dietary exposure to pyriproxyfen residues.
    iii. Non-dietary exposure and aggregate risk to adult sub-
populations. Acute, short-term, and intermediate-term dermal and 
inhalation risk assessments for residential exposure are not required 
due to the lack of significant toxicological effects observed. The 
results of a chronic residential post-application exposure and risk 
assessment for pet collar uses demonstrate that potential risks from 
pet collar uses do not exceed the Agency's level of concern. The 
estimated chronic term margin of exposure (MOE) for adults was 5,700.
    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 pre-natal and post-
natal 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 to infants and children. 
Using the conservative exposure assumptions described above, the 
percentage of the RfD that will be utilized by chronic dietary (food 
only) exposure to residues of pyriproxyfen ranges from 0.013 mg/kg bwt/
day children 6-12 years old, up to 0.0245 mg/kg bwt/day for infants (0 
years of age), 3.8 and 7.0% of the RfD, respectively. Adding the worse 
case potential incremental exposure to infants from pyriproxyfen in 
drinking water (0.9 x 10-4 mg/kg bwt/day) does not 
materially increase the aggregate, chronic dietary exposure and only 
increases the occupancy of the RfD by 0.009%. 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. Acute dietary exposure and risk infants and children. No acute 
dietary endpoint and dose were identified in the toxicology data base 
for pyriproxyfen; therefore, Valent believes that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate, acute dietary exposure to pyriproxyfen residues.
    iv. Non-dietary exposure and aggregate risk infants and children. 
Acute, short-term, and intermediate-term dermal and inhalation risk 
assessments for residential exposure are not required due to the lack 
of significant toxicological effects observed. The results of a chronic 
residential post-application exposure and risk assessment for pet 
collar uses demonstrate that potential risks from pet collar uses do 
not exceed the Agency's level of concern. The estimated chronic term 
MOE for children was 1,425.

F. International Tolerances

     There are presently no existing Codex maximum residue levels for 
pyriproxyfen.
FR Doc. 05-16301 Filed 8-16-05; 8:45 a.m.]
BILLING CODE 6560-50-S