[Federal Register Volume 68, Number 93 (Wednesday, May 14, 2003)]
[Rules and Regulations]
[Pages 25831-25837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12022]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0109; FRL-7305-9]


Pyriproxyfen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
pyriproxyfen in or on atemoya, biriba, cherimoya, custard apple, ilama, 
soursop, and sugar apple at 0.20 parts per million (ppm); avocado, 
black sapote, canistel, mamey sapote, mango, papaya, sapodilla and star 
apple at 1.0 ppm; okra at 0.02 ppm; fig at 0.30 ppm; and fig, dried at 
1.0 ppm. The Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective May 14, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0109, 
must be received on or before July 14, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Hoyt Jamerson, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone 
number: (703) 308-9368; 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 production (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. 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-2003-0109. 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/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    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.

II. Background and Statutory Findings

    In the Federal Register of March 7, 2003 (68 FR 11093) (FRL-7289-
8), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
pesticide petitions (PP) 2E6416, 2E6425, 2E6428, and 2E6436) by IR-4, 
681 US Highway 1 South, North Brunswick, NJ 08902-3390. That 
notice included a summary of the petitions prepared by Valent U.S.A. 
Corporation, the registrant. There were no comments received in 
response to the notice of filing.
    The petition requested that 40 CFR 180.510 be amended by 
establishing tolerances for residues of the insecticide pyriproxyfen, 
2-[1-methyl-2-(4-phenoxyphenoxy)ethoxy]pyridine, in or on atemoya, 
biriba, cherimoya, custard apple, ilama, soursop, and sugar apple at 
0.20 ppm (PP 2E6416); avocado, black sapote, canistel, mamey sapote, 
mango, papaya, sapodilla and star apple at 1.0 ppm (PP 2E6428); okra at 
0.02 ppm (PP 2E6436); fig at 0.30 ppm (PP 2E6425); and fig, dried at 
1.0 ppm (2E6425).
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

[[Page 25832]]

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for tolerances for residues of pyriproxyfen on 
atemoya, biriba, cherimoya, custard apple, ilama, soursop, and sugar 
apple at 0.20 ppm (PP 2E6416); avocado, black sapote, canistel, mamey 
sapote, mango, papaya, sapodilla and star apple at 1.0 ppm (PP 2E6428); 
okra at 0.02 ppm (PP 2E6436); fig at 0.30 ppm (PP 2E6425); and fig, 
dried at 1.0 ppm (2E6425). EPA's assessment of exposures and risks 
associated with establishing the tolerances follows.

A. Toxicological Profile

    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. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The no observed adverse effect level (NOAEL) and the lowest 
observed adverse effect level (LOAEL) from the toxicity studies 
reviewed as well as the nature of the toxic effects caused by 
pyriproxyfen are discussed in Unit III.A. of the Federal Registers of 
June 5, 2001 (66 FR 30065) (FRL-6782-5), August 28, 2002 (67 FR 55150) 
(FRL-7195-7), and March 7, 2003 (68 FR 10972) (FRL-7289-6).

B. Toxicological Endpoints

    The dose at which the NOAEL from the toxicology study identified as 
appropriate for use in risk assessment is used to estimate the 
toxicological level of concern (LOC). However, the LOAEL is sometimes 
used for risk assessment if no NOAEL was achieved in the toxicology 
study selected. An uncertainty factor (UF) is applied to reflect 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and in the variations in sensitivity among members of the 
human population as well as other unknowns. An UF of 100 is routinely 
used, 10X to account for interspecies differences and 10X for 
intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor (SF) 
is retained due to concerns unique to the FQPA, this additional factor 
is applied to the RfD by dividing the RfD by such additional factor. 
The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-6 or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for pyriproxyfen used for human risk assessment is shown in 
Unit III.B. of the Federal Register of March 7, 2003 (68 FR 10972).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.510) for the residues of pyriproxyfen, in or on 
a variety of raw agricultural commodities. There are no significant 
livestock feed items associated this action, thus the proposed uses 
will not result in the transfer of additional pyriproxyfen residues to 
livestock. Risk assessments were conducted by EPA to assess dietary 
exposures from pyriproxyfen in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. An acute dietary exposure analysis was not 
conducted since no acute doses or toxicological endpoints were selected 
for the general U.S. population (including infants and children) or the 
females 13-50 years old population subgroup.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID[reg]) which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII) and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the chronic exposure 
assessments: The chronic dietary exposure assessment was performed 
using published and proposed tolerance levels, DEEM[reg] default 
processing factors, and 100% crop treated (PCT) assumptions for all 
commodities. Some of the crops (atemoya, custard apple, ilama, birba, 
sapodilla, black and white sapote, star apple, and ugli fruit) 
considered in this risk assessment are not included in the present 
version of DEEM-FCID[reg] due to their low consumption. In these cases, 
the DEEM-FCID[reg] program underestimates the exposure to pyriproxyfen 
residues from these crops; however, because the consumption levels of 
these crops is so low (on a national basis), inclusion of these crops 
in a future version of DEEM-FCID[reg] would likely make no difference 
in the overall predicted exposures to pyriproxyfen residues.
    iii. Cancer. Pyriproxyfen was classified by the EPA (June, 1995) as 
a ``Group E'' chemical - no evidence of carcinogenicity to humans based 
on the absence of carcinogenicity in mice and rats.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for pyriproxyfen in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of pyriproxyfen.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of

[[Page 25833]]

pesticide concentrations in an index reservoir. The screening 
concentration in ground water (SCI-GROW) model is used to predict 
pesticide concentrations in shallow ground water. For a screening-level 
assessment for surface water EPA will use FIRST (a Tier I model) before 
using PRZM/EXAMS (a Tier II model). The FIRST model is a subset of the 
PRZM/EXAMS model that uses a specific high-end runoff scenario for 
pesticides. FIRST and PRZM/EXAMS incorporate an index reservoir 
environment, and a percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    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 percent reference dose (%RfD) or 
percent 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. Since DWLOCs address total aggregate 
exposure to pyriproxyfen they are further discussed in the aggregate 
risk sections in Unit III.E.
    EPA determined that the residue of concern in water is pyriproxyfen 
per se. Drinking water estimates include surface water EECs based on 
the linked PRZM/EXAMS models and the SCI-GROW regression model, which 
was developed from studies with different hydrology and study 
conditions. Both models assumed a maximum seasonal application rate of 
0.11 lb active ingredient per acre, applied 3 times per year. (The 
registered use for citrus). Based on the PRZM/EXAMS and SCI-GROW models 
the EECs of pyriproxyfen for acute exposures are estimated to be 2.15 
parts per billion (ppb) for surface water and 0.006 ppb for ground 
water. The EECs for chronic exposures are estimated to be 0.40 ppb for 
surface water and 0.006 ppb for ground water.
    3. From 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).
    Pyriproxyfen is currently registered for use on the following 
residential non-dietary sites: Residential sites for flea and tick 
control products (home environment and pet treatments) as well as 
products for ant and roach control (indoor and outdoor applications). 
Formulations include carpet powders, foggers, aerosol sprays, liquids 
(shampoos, sprays, and pipettes), granules, bait (indoor and outdoor), 
and impregnated materials (pet collars).
    The risk assessment was conducted using the following residential 
exposure assumptions: There is a potential for short-term dermal and 
inhalation exposures to pet owners and homeowners who apply products 
containing pyriproxyfen (handlers); however, EPA did not identify any 
short-term dermal or inhalation endpoints. Because no short-term dermal 
or inhalation endpoints could be identified, EPA expects no short-term 
dermal or inhalation risks from exposure to pyriproxyfen. There is also 
a potential for non-dietary oral exposures (hand-to-mouth exposures) 
and dermal exposure following applications around the home and on pets 
for flea and tick control (carpet powder and pet shampoo). Short- and 
intermediate-term non-dietary oral and long-term dermal exposure 
assessments were included for toddlers since EPA selected toxicology 
endpoints for these exposures and toddlers are expected to have higher 
exposures than adults from treated home environments and pets due to 
their behavior patterns. Although EPA did not select a long-term non-
dietary oral endpoint for pyriproxyfen, EPA used the chronic endpoint 
for the chronic (long-term) aggregate risk assessment.
    Toddlers could potentially be exposed to pyriproxyfen residues on 
treated carpets, floors, furniture, and pets as follows: (i). Hand-to-
Mouth: Short-, intermediate, and long-term hand-to-mouth exposures by 
toddlers from treated carpets, flooring (the efficacy of carpet powders 
is approximately 365 days); (ii). Hand-to-mouth: Short- and 
intermediate-term hand-to-mouth exposures by toddlers from petting 
treated animals (shampoos, sprays, spot-on treatments and collars). 
Long-term hand-to-mouth exposures by toddlers from petting treated 
animals (pet collars; efficacy of pet collars up to 395 days); (iii). 
Dermal: Long-term dermal exposures from treated carpets, flooring, and 
pets. (iv). Ingestion of granules or bait by toddlers (acute, episodic 
event): For the granular ingestion scenario, the Agency believes that 
if a toddler were to be exposed to a pellet/granular formulation (i.e., 
ant bait), the event is most likely to be ``episodic,'' that is, a one 
time occurrence and not likely to be repeated. It is not likely that a 
toddler would repeatedly locate and ingest very small, sand colored 
granules. For pyriproxyfen, EPA did not select an acute dietary 
endpoint, since an appropriate endpoint could not be attributed to a 
single oral dose; therefore, no granular assessment was performed.
    Exposure and risk estimates from post-application exposure to 
indoor crack and crevice treatments are not presented in this 
assessment as indoor broadcast treatments (i.e., carpet powders and 
sprays) are anticipated to have a higher exposure potential. 
Additionally, the Agency acknowledges that pet owners could retreat the 
home environment and/or the pet near the end of the efficacy period 
identified on the product labels. However, there are no chemical-
specific residue data for pyriproxyfen to determine the dissipation 
rate of residues or whether residues may be additive upon retreatment. 
Therefore, a Tier I assessment was performed based on Day 0 residues 
without accounting for daily residue dissipation. EPA anticipates that 
this assessment is protective as pyriproxyfen residues would be 
expected to dissipate from Day 0 residue values.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether [pyriproxyfen] has a common mechanism of toxicity with other 
substances. 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 pyriproxyfen 
and any other substances and pyriproxyfen does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that pyriproxyfen 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 concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common

[[Page 25834]]

mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. Based on the available data, 
there is no quantitative and qualitative evidence of increased 
susceptibility observed following in utero pyriproxyfen exposure to 
rats and rabbits or following pre/post natal exposure in the 2-
generation reproduction study.
    3. Conclusion. There is a complete toxicity data base for 
pyriproxyfen and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X safety factor to protect infants and children should be 
reduced to 1X because there was no evidence of prenatal or postnatal 
extra sensitivity or increased susceptibility in developmental studies 
in rats and rabbits, and in reproduction studies in rats. Likewise, 
there was no quantitative or qualitative evidence of increased 
susceptibility to rat or rabbit fetuses identified in the guideline 
prenatal developmental toxicity studies for rats and rabbits. 
Additionally, in the 2 non-guideline studies that evaluated perinatal 
and prenatal development, there was no evidence of quantitative or 
qualitative increased susceptibility. In 1-study, when pregnant rats 
were treated from gestation day 17 to lactation day 20, the resulting 
toxicity was comparable between adults (clinical signs, decreased body 
weight gain and food consumption) and offspring (decreased body weight 
and dilation of the renal pelvis) at the same dose. In the other study, 
when rats were exposed to pyriproxyfen prior to and in the early stages 
of pregnancy, no developmental toxicity was seen at the limit dose. 
Lastly, in the reproduction toxicity study, offspring toxicity 
(decreased body weight on pups during lactation days 14 to 21) occurred 
only in the presence of decreases in body weight in parental animals at 
the same dose level (i.e., comparable toxicity in adults and 
offspring).

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking 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 residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water (e.g., allowable chronic water exposure milligrams/
kilogram/day (mg/kg/day) = cPAD - (average food + residential 
exposure)). This allowable exposure through drinking water is used to 
calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by EPAs Office of Water are used to calculate DWLOCs: 2 
liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. An acute dietary RfD for females 13-50 and the 
general U.S. population, including infants and children, was not 
selected because an acute oral endpoint attributable to a single-dose 
exposure could not be identified; therefore, acute dietary risk is not 
expected.
    2. Chronic aggregate risk. Using the exposure assumptions described 
in this unit for chronic (long-term) exposure, EPA has concluded that 
exposure to pyriproxyfen from food will utilize 1.1% of the cPAD for 
the U.S. population, 2% of the cPAD for all infants, less than 1 year 
old and 3.9% of the cPAD for children 1 to 2 years old, the 
subpopulation at greatest exposure. Pyriproxyfen is an active 
ingredient in pesticide products registered for residential use. Based 
on the use patterns, the residential risk assessment was performed for 
toddlers since they are anticipated to have the higher chronic 
residential exposure to residues of pyriproxyfen. EPA considered 
background chronic-dietary exposure (food + water), long-term, 
residential non-dietary oral exposures (hand-to-mouth exposures by 
toddlers following applications around the home and on pets for flea 
and tick control-carpet powder and pet shampoo), and long-term dermal 
exposure to toddlers. The total chronic food and residential aggregate 
MOEs were calculated. As these MOEs are greater than 100, the chronic 
aggregate risk does not exceed EPA's level of concern. In addition, 
there is potential for chronic dietary exposure to pyriproxyfen in 
drinking water. After calculating DWLOCs and comparing them to the EECs 
for surface and ground water, EPA does not expect the aggregate chronic 
exposure to exceed the Agency's level of concern, as shown in Table 1 
of this unit:

[[Page 25835]]



              Table 1.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population...............................         9,200          100          0.4        0.006       12,000
All infants < 1 year..........................         1,000          100          0.4        0.006        3,200
Children 1-2 years............................           860          100          0.4        0.006        3,100
Children 3-5 years............................           940          100          0.4        0.006        3,100
Females 13-49 years...........................        13,000          100          0.4        0.006       10,000
----------------------------------------------------------------------------------------------------------------

    3. Short-term aggregate risk. Short-term aggregate exposure takes 
into account residential exposure plus chronic exposure to food and 
water (considered to be a background exposure level). Pyriproxyfen is 
currently registered for use that could result in short-term 
residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic food and water and short-term 
exposures for pyriproxyfen. EPA considered background chronic-dietary 
exposure (food + water) and short-term, residential non-dietary oral 
exposures (hand-to-mouth exposures by toddlers following applications 
around the home and on pets for flea and tick control-carpet powder and 
pet shampoo).
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs for toddlers ranging from 1,600 for 
children 1 to 2 years old to 1,800 for children less than 1 year old. 
These aggregate MOEs do not exceed the Agency's level of concern for 
aggregate exposure to food and residential uses. In addition, short-
term DWLOCs were calculated and compared to the EECs for chronic 
exposure of pyriproxyfen in ground water and surface water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect short-term aggregate exposure to 
exceed the Agency's level of concern, as shown in Table 2 of this unit:

                   Table 2.--Aggregate Risk Assessment for Short-Term Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground    Sh ort-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
All infants (<1 year).........................         1,800          100          0.4        0.006        9,400
Children 1-2 years............................         1,600          100          0.4        0.006        9,400
Children 3-5 years............................         1,700          100          0.4        0.006        9,400
----------------------------------------------------------------------------------------------------------------

    4. Intermediate-term aggregate risk.Intermediate-term aggregate 
exposure takes into account residential exposure plus chronic exposure 
to food and water (considered to be a background exposure level).
    Pyriproxyfen is currently registered for use(s) that could result 
in intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and 
intermediate-term exposures for pyriproxyfen. EPA considered background 
chronic-dietary exposure (food + water) and intermediate-term, 
residential non-dietary oral exposures (hand-to-mouth exposures by 
toddlers following applications around the home and on pets for flea 
and tick control-carpet powder and pet shampoo).
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food and 
residential exposures aggregated result in aggregate MOEs for toddlers 
ranging from 580 for children 1 to 2 years old to 650 for infants less 
than 1 year old. These aggregate MOEs do not exceed the Agency's level 
of concern for aggregate exposure to food and residential uses. In 
addition, intermediate-term DWLOCs were calculated and compared to the 
EECs for chronic exposure of pyriproxyfen in ground water and surface 
water. After calculating DWLOCs and comparing them to the EECs for 
surface and ground water, EPA does not expect intermediate-term 
aggregate exposure to exceed the Agency's level of concern, as shown in 
Table 3 of this Unit:

               Table 3.--Aggregate Risk Assessment for Intermediate-Term Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
                                                             Aggregate
                                                Aggregate     Level of     Surface       Ground    Intermediate-
             Population Subgroup               MOE (Food +    Concern     Water EEC    Water EEC     Term DWLOC
                                              Residential)     (LOC)        (ppb)        (ppb)         (ppb)
----------------------------------------------------------------------------------------------------------------
All infants < 1 year........................           650          100          0.4        0.006         3,000
Children 1-2 years..........................           580          100          0.4        0.006         2,900
Children 3-5 years..........................           620          100          0.4        0.006         2,900
----------------------------------------------------------------------------------------------------------------

    5. Aggregate cancer risk for U.S. population. There is no evidence 
of carcinogenicity to humans based on carcinogenicity studies in male 
and female rats and mice. The Agency concludes that pesticidal uses of

[[Page 25836]]

pyriproxyfen are not likely to pose a carcinogenic hazard to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to pyriproxyfen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromotography/nitrogen 
phosphorous detector method (RM-33P-1-3a)) is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: [email protected].

B. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits 
established for residues of pyriproxyfen in or on the subject food 
commodities.

V. Conclusion

    Therefore, the tolerance is established for residues of 
pyriproxyfen, [2-[1-methyl-2-(4-phenoxyphenoxy)ethoxy]pyridine], in or 
on atemoya, biriba, cherimoya, custard apple, ilama, soursop, and sugar 
apple at 0.20 parts per million (ppm); avocado, black sapote, canistel, 
mamey sapote, mango, papaya, sapodilla and star apple at 1.0 ppm; okra 
at 0.02 ppm; fig at 0.30 ppm; and fig, dried at 1.0 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0109 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before July 14, 
2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential 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. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2003-0109, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

[[Page 25837]]

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-13, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled 
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by State and local officials in the development of 
regulatory policies that have federalism implications.'' ``Policies 
that have federalism implications'' is defined in the Executive Order 
to include regulations that have ``substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.'' This final rule directly regulates 
growers, food processors, food handlers and food retailers, not States. 
This action does not alter the relationships or distribution of power 
and responsibilities established by Congress in the preemption 
provisions of section 408(n)(4) of the FFDCA. For these same reasons, 
the Agency has determined that this rule does not have any ``tribal 
implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000). Executive Order 13175, requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by tribal officials in the development of regulatory policies that have 
tribal implications.'' ``Policies that have tribal implications'' is 
defined in the Executive Order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This rule will not have substantial 
direct effects on tribal governments, on the relationship between the 
Federal Government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian tribes, 
as specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: May 6, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

0
2. Section 180.510 is amended by alphabetically adding commodities to 
the table in paragraph (a) to read as follows:


Sec.  180.510  Pyriproxyfen: tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Atemoya...................................  0.20
Avocado...................................  1.0
Biriba....................................  0.20
Black sapote..............................  1.0
                                * * * * *
Canistel..................................  1.0
Cherimoya.................................  0.20
                                * * * * *
Custard apple.............................  0.20
                                * * * * *
Fig.......................................  0.30
Fig, dried................................  1.0
                                * * * * *
Ilama.....................................  0.20
                                * * * * *
Mamey sapote..............................  1.0
Mango.....................................  1.0
                                * * * * *
Okra......................................  0.02
                                * * * * *
Papaya....................................  1.0
                                * * * * *
Sapodilla.................................  1.0
                                * * * * *
Soursop...................................  0.20
                                * * * * *
Star apple................................  1.0
                                * * * * *
Sugar apple...............................  0.20
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 03-12022 Filed 5-13-03; 8:45 am]
BILLING CODE 6560-50-S