[Federal Register Volume 67, Number 108 (Wednesday, June 5, 2002)]
[Notices]
[Pages 38660-38664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-13810]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0065; FRL-7177-4]


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 control number OPP-2002-0065, 
must be received on or before July 5, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number OPP-2002-0065 in the subject line on the first page of 
your response.

FOR FURTHER INFORMATION CONTACT: By mail: Sidney Jackson, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-7610; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
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Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
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 Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-2002-0065. The official 
record consists of the documents specifically referenced in this 
action, any public comments received during an applicable comment 
period, and other information related to this action, including any 
information claimed as confidential business information (CBI). This 
official record includes the documents that are physically located in 
the docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period, is available 
for inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-2002-0065 in the subject line on 
the first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number OPP-2002-0065. Electronic comments 
may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
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

[[Page 38661]]

information claimed as CBI must be submitted for inclusion in the 
public version of the official record. Information not marked 
confidential will be included in the public version of the official 
record without prior notice. If you have any questions about CBI or the 
procedures for claiming CBI, please consult the person identified 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 
control 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 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: May 17, 2002.
Robert Forrest,
Acting Director, Registration Division, Office of Pesticide Programs.

III. Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by Valent U.S.A. Corporation, P.O. Box 8025, 
Walnut Creek, CA 94596-8025 and represents the view of Valent U.S.A. 
Corporation. EPA is publishing the petition summary verbatim without 
editing it in any way. 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.

PP 1E6272, 1E6285, and 2E6353

    EPA has received pesticide petitions (PP) 1E6272, 1E6285, and 
2E6353 from the Interregional Research Project Number 4 (IR-4), 
Technology Centre of New Jersey, Rutgers, the State University of New 
Jersey, 681 U.S. Highway No. 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 part 180 by establishing tolerances for residues of 
pyriproxyfen, 2-[1-methyl-2-(4-phenoxyphenoxy)ethoxy]pyridine, in or on 
the raw agricultural commodities as follows:
    1. PP 1E6272 proposes tolerances for lychee, longan, Spanish lime, 
rambutan, and pulasan at 0.3 parts per million (ppm).
    2. PP 1E6285 proposes tolerances for guava, feijoa, jaboticaba, wax 
jambu, starfruit, passionfruit, and acerola at 0.1 ppm, and
    3. PP 2E6353 proposes tolerances for Bushberry subgroup 13 B at 1.0 
ppm and lingonberry, juneberry, and salal at 1.0 ppm.
    EPA has determined that the petitions contain data or information 
regarding the elements set forth in section 408(d)(2) of the Federal 
Food Drug and Cosmetic Act (FFDCA); however, EPA has not fully 
evaluated the sufficiency of the submitted data at this time or whether 
the data supports granting of the petitions. Additional data may be 
needed before EPA rules on the petitions. Pyriproxyfen is manufactured 
by Sumitomo Chemical Company, represented in the United States by 
Valent U.S.A. Corporation.

A. Residue Chemistry

    1. Plant metabolism. Metabolism of 14C-pyriproxyfen 
labelled 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 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/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 --i. Lychee. Three lychee field residue 
trials were conducted in 1998 in EPA Region 13. Each field site 
received two pyriproxyfen applications at 0.11 lb active ingredient/
acre (a.i./A), with an interval of 10 to 11 days between applications, 
and a preharvest interval of 11 to 13 days. Pyriproxyfen residues on 
treated lychee samples ranged from

[[Page 38662]]

0.0759 to 0.272 ppm. These data support a tolerance for pyriproxyfen in 
or on lychee of 0.3 ppm.
    ii. Guava. Three guava field residue trials were conducted in 1999 
in EPA Region 13. Each field site received two pyriproxyfen 
applications at 0.11 lb a.i./A, with an interval of 13 days between 
applications, and a pre-harvest interval of 14 to 15 days. Pyriproxyfen 
residues on treated guava samples ranged from <0.025 to 0.055 ppm. The 
data support a tolerance for pyriproxyfen in or on guava of 0.1 ppm.
    iii. Blueberry. Eight blueberry field residue trials were conducted 
in 1999. Three trials were conducted in EPA Region 2, three trials in 
EPA Region 5, one trial in EPA Region 1, and one trial in EPA Region 
12. Each field site received two pyriproxyfen applications at 0.1 lb 
ai/A with a retreatment interval ranging between 13 to 15 days. At 
seven trial locations samples were collected 6 to 8 days after the last 
application. At one trial location, samples were collected at 2, 7, 10, 
14 and 21 days after the last application. Pyriproxyfen residues ranged 
from 0.14 ppm to 0.64 ppm for treated samples collected 6 to 8 days 
after the last application. In the residue decline study, pyriproxyfen 
residues ranged from 0.10 ppm to 0.22 ppm in treated samples collected 
at the first three sampling intervals, declining to as low as 0.03 ppm 
after 21 days after the last application. These data support a 
tolerance for pyriproxyfen in or on blueberries and commodities within 
the bushberry subgroup of 1.0 ppm.

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 dated April 4, 
2001, (FRL-6772-4) (66 FR 17883).
    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 bw) (phenoxyphenyl and pyridyl label), and 
after a single oral dose of 2 mg/kg bw, phenoxyphenyl label only, 
following 14 daily oral doses at 2 mg/kg bw of unlabelled material. For 
all dose groups, most (88-96%) of the administered radiolabel was 
excreted in the urine and feces within two days after radiolabeled test 
material dosing, and 92-98% of the administered dose was excreted 
within seven 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.
    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 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 bw. The two pyridines, 2-OH-pyridine and 2,5-diOH-pyridine, 
gave acute oral LD50 values of 124 (male) and 166 (female) 
mg/kg bw, and 1,105 (male) and 1,000 (female) mg/kg bw, 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, Valent concludes 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, the 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 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. The results from 
several representative subgroups are listed below. Chronic exposure to 
the overall U.S. population is estimated to be 0.002984 mg/kg bw/day, 
representing 0.9% of the Reference Dose (RfD). For the most highly 
exposed sub-population, children 1 to 6 years of age, exposure is 
calculated to be 0.007438 mg/kg bw/day, or 2.1% 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.

  Calculated Chronic Dietary Exposures to the Total U.S. Population and
        Selected Sub-Populations to Pyriproxyfen Residues in Food
------------------------------------------------------------------------
                                  Exposure (mg/kg bw/
       Population Subgroup               day)           Percent of RfD
------------------------------------------------------------------------
Total U.S. population (all        0.002984            0.853
 seasons)
Children (1-6 years)              0.007438            2.125
Non-Nursing infants (<1 year      0.006483            1.852
 old)
All infants (<1 year old)         0.005604            1.601
Children (7-12 years)             0.004159            1.188

[[Page 38663]]

 
Females (13+/nursing)             0.002964            0.847
Nursing infants (<1 year old)     0.002601            0.743
------------------------------------------------------------------------

    ii. Drinking water. Since pyriproxyfen is applied outdoors to 
growing agricultural crops, the potential exists for pyriproxyfen or 
its metabolites to reach ground 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 
GENEEC 1.3. 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 bw/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.
    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 and intermediate term dermal or inhalation 
exposure to pyriproxyfen. The Valent Corporation 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 (ai)/day, average bw for 
a 1-6 year old child of 10 kg, the a.i. 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 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 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 (Aug. 4, 1997) and other 
subsequent EPA publications pursuant to the Food Quality Protection 
Act.

E. Safety Determination

    1. U.S. population. --i. Chronic dietary exposure and risk 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 bw/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 bw/day, 
0.607 to 1.100% of the RfD. Addition of the small but worse case 
potential chronic exposure from drinking water (calculated above) 
increases exposure by only 4.57 x 10-6 mg/kg bw/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. 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.
    ii. Acute dietary exposure and risk 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 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 
MOE for adults was 430,000.
    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

[[Page 38664]]

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 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 0.002601 mg/kg bw/day 
for nursing infants, up to 0.007438 mg/kg bw/day for children (1 to 6 
years of age), 0.743 to 2.125% of the RfD, respectively. Adding the 
worse case potential incremental exposure to infants and children from 
pyriproxyfen in drinking water (1.6 x 10-5 mg/kg bw/day) 
does not materially increase the aggregate, chronic dietary exposure 
and only increases the occupancy of the RfD by 0.0046% to 2.130% for 
Children (1 to 6 years of age). 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 61,000.

F. International Tolerances

    There are no presently existing Codex maximum residue levels (MRLs) 
for pyriproxyfen.
[FR Doc. 02-13810 Filed 6-4-02; 8:45 am]
BILLING CODE 6560-50-S