[Federal Register Volume 70, Number 184 (Friday, September 23, 2005)]
[Rules and Regulations]
[Pages 55733-55740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-19059]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0246; FRL-7737-8]


Pyriproxyfen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
pyriproxyfen in or on grass, forage, fodder, and hay, group 17, forage; 
grass, forage, fodder, and hay, group 17, hay; vegetable, legume, group 
6; onion, dry bulb; grape; strawberry; sapote, white; and citrus 
hybrids. 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 September 23, 2005. Objections and 
requests for hearings must be received on or before November 22, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number OPP-2005-0246. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy 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.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: 703-308-3194; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers;

[[Page 55734]]

greenhouse, nursery, and floriculture workers; ranchers; pesticide 
applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    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 Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), 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 E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines athttp://www.epa.gpo/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of August 17, 2005 (70 FR 48413) (FRL-7732-
1, EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
3E6596, 3E6750, 4E6866, 4E6865, and 3E6582) by IR-4, 681 US Highway 
1 South, North Brunswick, NJ 08902-3390. The petitions 
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 legume vegetables, crop 
subgroups 6a, 6b, and 6c at 0.2 part per million (ppm) (PP 3E6596); 
onion, dry bulb at 0.05 ppm (PP 3E6750); grape at 2.5 ppm, and raisin 
at 4.0 ppm (PP 4E6866); strawberry at 0.3 ppm (PP 4E6865); white 
sapote, and ugli fruit at 0.3 ppm (PP 3E6582). The petition for onion, 
dry bulb (PP 3E6750) was subsequently amended from 0.05 ppm to 0.15 
ppm. The Agency has also determined a separate tolerance for raisin is 
not necessary. In addition, ugli fruit has been translated to citrus 
hybrids. No comments were recived on the notice of filing.
    Additionally, in the Federal Register of December 22, 2004 (69 FR 
76724) (FRL-7689-6), EPA issued a notice pursuant to section 408(d)(3) 
of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
petition (PP 4F6847) by Valent USA Corporation, 1600 Riviera Ave., 
Suite 200, Walnut Creek, California 94596-8025. 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 grass forage and hay (crop 
group 17). The Agency has subsequently amended the petition to 
establish tolerances for grass, forage, fodder, and hay, group 17, 
forage at 0.70 ppm (previously requested at 0.5 ppm), and grass, 
forage, fodder, and hay, group 17, hay at 1.1 ppm (previously requested 
at 1.0 ppm). That notice included a summary of the petitions prepared 
by Valent USA Corporation], the registrant. Comments were received on 
the notice of filing. EPA's response to these comments is discussed in 
Unit IV.C.
    Section 408(b)(2)(A)(i) of 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 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 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 FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/health/human.htm

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
these actions. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for tolerances for residues of pyriproxyfen on 
vegetable, legume, group 6 at 0.20 ppm; onion, dry bulb at 0.15 ppm; 
grape at 2.5 ppm; strawberry at 0.30 ppm; white sapote at 0.30 ppm; 
citrus hybrids at 0.30 ppm; grass, forage, fodder, and hay, group 17, 
forage at 0.70 ppm; and grass, forage, fodder, and hay, group 17, hay 
at 1.1 ppm. EPA's assessment of exposures and risks associated with 
establishing these tolerances follow.

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. Specific information on the studies received and the nature 
of the toxic effects caused by pyriproxyfen as well as the no observed 
adverse effect level (NOAEL) and the lowest observed adverse effect 
level (LOAEL) from the toxicity studies can be found at http://www.epa.gov/fedrgstr/EPA-PEST/2003/May/Day-14/p12022.htm.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which 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 
of concern identified 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.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of

[[Page 55735]]

cancer risk, estimates risk in terms of the probability of occurrence 
of additional cancer cases.
    A summary of the toxicological endpoints for pyriproxyfen used for 
human risk assessment is shown in the following Table 1:

     Table 1.--Summary of Toxicological Dose and Endpoints for Pyriproxyfen for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure/Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years of  None                     None                     An appropriate endpoint
 age) and general population                                                              attributable to a
                                                                                          single oral dose was
                                                                                          not available in the
                                                                                          data base, including
                                                                                          maternal toxicity in
                                                                                          the developmental
                                                                                          toxicity studies
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 35.1 mg/kg/day   Special FQPA SF = 1X     Subchronic toxicity and
                                       UF = 100...............  Chronic Population        chronic toxicity
                                       Chronic Reference Dose    Adjusted Dose (cPAD) =   (feeding) - rat
                                        (cRfD) = 0.35 mg/kg/     cRfD.                   LOAEL = 141.28 mg/kg/
                                        day.                    Special FQPA SF = 0.35    day based on decreased
                                                                 mg/kg/day.               body weight and
                                                                                          clinical pathology
                                                                                          results
----------------------------------------------------------------------------------------------------------------
Short-term incidental, oral (1 to 30   Oral Maternal            LOC for Margin of        Rat developmental
 days) (Residential)                   NOAEL = 100 mg/kg/day..   Exposure (MOE) = 100     toxicity study
                                                                 (Residential)           LOAEL = 300 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight, body
                                                                                          weight gain, and food
                                                                                          consumption, and
                                                                                          increased water
                                                                                          consumption
----------------------------------------------------------------------------------------------------------------
Intermediate-term incidental, oral (1- Oral NOAEL = 35.1 mg/kg/ LOC for MOE = 100        Subchronic toxicity and
 6 months) (Residential)                day                      (Residential)            chronic toxicity
                                                                                          (feeding) - rat (co-
                                                                                          critical)
                                                                                         LOAEL = 141.28 mg/kg/
                                                                                          day based on decreased
                                                                                          body weight and
                                                                                          clinical pathology
                                                                                          results
----------------------------------------------------------------------------------------------------------------
Short-term, and intermediate-term      None                     None                     Based on the systemic
 dermal (1-30 days and 1-6 months)                                                        toxicity NOAEL of
 (Occupational/Residential)                                                               1,000 mg/kg/day (limit
                                                                                          dose) in the 21-day
                                                                                          dermal toxicity study
                                                                                          in rats,
                                                                                          quantification of
                                                                                          dermal risks is not
                                                                                          required. In addition,
                                                                                          no developmental
                                                                                          concern (toxicity)
                                                                                          were seen in either
                                                                                          rats or rabbits
----------------------------------------------------------------------------------------------------------------
Long-term dermal (6 months to          Dermal (or oral) study   LOC for MOE = 100        Subchronic toxicity and
 lifetime) (Occupational/Residential)   NOAEL = 35.1 mg/kg/day   (Residential)            chronic toxicity
                                                                                          (feeding) - rat(co-
                                                                                          critical)
                                                                                         LOAEL = 141.28 mg/kg/
                                                                                          day based on decreased
                                                                                          body weight and
                                                                                          clinical pathology
                                                                                          results
----------------------------------------------------------------------------------------------------------------
Short-term, and intermediate-term      None                     None                     28-day inhalation
 dermal (1 to 30 days and 1-6                                                             toxicity - rats. Based
 months)(Residential)                                                                     on the absence of
                                                                                          significant toxicity
                                                                                          at the LOAEL of 1.0 mg/
                                                                                          L (limit dose), the
                                                                                          quantification of
                                                                                          inhalation risks is
                                                                                          not required. In
                                                                                          addition, no
                                                                                          developmental concern
                                                                                          (toxicity) were seen
                                                                                          in either rats or
                                                                                          rabbits
----------------------------------------------------------------------------------------------------------------
Long-term dermal (6 months to          Dermal oral study NOAEL  LOC for MOE = 100        Subchronic and chronic
 lifetime) (Occupational/Residential)   = 35.1 mg/kg/day         (Residential)            toxicity (feeding) -
                                        (inhalation absorption                            rat (co-critial)
                                        rate = 100%)                                     LOAEL = 141.28 mg/kg/
                                                                                          day based on decreased
                                                                                          body weight and
                                                                                          clinical pathology
                                                                                          results
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Cancer classification    None                     No evidence of
                                        (``Group E'')                                     carcinogenicity
----------------------------------------------------------------------------------------------------------------

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 
the following raw agricultural commodities: Acerola at 0.10 part per 
million (ppm); almond, hulls at 2.0 ppm; apple, wet pomace at 0.8 ppm; 
atemoya at 0.20 ppm; avocado at 1.0 ppm; biriba at 0.20 ppm; black 
sapote at 1.0 ppm; brassica, head and stem, subgroup at 5A at 0.70 ppm; 
brassica, leafy greens, subgroup 5B at 2.0 ppm; bushberry subgroup 13B 
at 1.0 ppm; canistel at 1.0 ppm; cherimoya at 0.20 ppm; citrus, oil at 
20 ppm; citrus, dried pulp at 2.0 ppm; cotton, gin byproducts at 2.0 
ppm; cotton, undelinted seed at 0.05 ppm; custard apple at 0.20 ppm; 
feijoa at 0.10 ppm; fig at 0.30 ppm; fig, dried at 1.0 ppm; fruit, 
citrus at 0.3 ppm; fruit, pome at 0.2 ppm; fruit, stone, group 12 at 
1.0 ppm; guava at 0.10 ppm; ilama at 0.20 ppm; jaboticaba at 0.10 ppm; 
juneberry at 1.0 ppm; lingonberry at 1.0 ppm; logan at 0.30 ppm; lychee 
at 0.30 ppm;

[[Page 55736]]

mamey sapote at 1.0 ppm; mango at 1.0 ppm; okra at 0.02 ppm; olive at 
1.0 ppm; olive, oil at 2.0 ppm; papaya at 1.0 ppm; passionfruit at 0.10 
ppm; pistachio at 0.02 ppm; pulasan at 0.30 ppm; rambutan at 0.30 ppm; 
salal at 1.0 ppm; sapodilla at 1.0 ppm; soursop at 0.20 ppm; spanish 
lime at 0.30 ppm; star apple at 1.0 ppm; starfruit at 0.10 ppm; sugar 
apple at 0.20 ppm; tree nut at 0.02 ppm; vegetable, cucurbit, group 9 
at 0.10 ppm; vegetable, fruiting, group 8 at 0.2 ppm; walnut at 0.02 
ppm; and wax jambu at 0.10 ppm. Risk assessments were conducted by EPA 
to assess dietary exposures from pyriproxyfen in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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 1 day or single exposure. No such effects were 
identified in the toxicological studies for pyriproxyfen, therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the Dietary Exposure Evaluation Model software 
with the Food Commodity Intake Database (DEEMTM/FCID), which 
incorporates food consumption data as reported by respondents in the 
U.S. Department of Agriculture (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 Tier 1 
chronic analysis assumed 100% crop treated, DEEMTM 7.81 
default processing factors and tolerance-level residues for all 
commodities. Percent crop treatedand/or anticipated residues were not 
used.
    iii. Cancer. The Agency classified pyriproxyfen as a ``Group E'' 
chemical, no evidence for carcinogenicity to humans, based on the 
absence of evidence of carcinogenicity in male and female rats as well 
as in male and female mice. Therefore, a cancer risk assessment was not 
performed.
    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. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on EPA's Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and, Screening Concentration in Ground Water (SCI-
GROW) models, the Estimated Environmental Concentrations (EECs) of 
pyriproxyfen for ground water exposures are estimated to be 0.006 parts 
per billion (ppb) (acute and chronic). Surface water exposures are 
estimated to be 2.15 ppb (peak concentration), and 0.40 ppb (long term 
average).
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model DEEMTM/FCID using 
long-term average concentrations for surface water (0.40 ppb) to access 
the contribution to drinking 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 products for flea and tick 
control (home environment and pet treatments), and ant and roach 
control (indoor and outdoor applications). Formulations include carpet 
powders, foggers, aerosol sprays, liquids (shampoos, sprays and 
pipettes for pet treatments), granules, bait (indoor and outdoor), and 
impregnated materials (pet collars). Adults and toddlers could 
potentially be exposed to pyriproxyfen residues on treated carpets, 
floors, upholstery, and pets; however, since the Agency did not select 
any short-term dermal or inhalation endpoints, only a post-application 
residential assessment was conducted. Toddlers are anticipated to have 
higher exposures than adults from treated home environments and pets 
due to their behavior patterns. The risk assessment was conducted using 
the following residential exposure assumptions:
    i. Hand-to-mouth: Short-term, intermediate term, and long-term 
hand-to-mouth exposures to toddlers from treated carpets, flooring 
(note the efficacy of carpet powders is approximately 365 days).
    ii. Hand-to-mouth: Short-term and intermediate-term hand-to-mouth 
exposures to toddlers from petting treated animals (shampoos, sprays, 
spot-on treatments and collars). Long-term hand-to-mouth exposures to 
toddlers from petting treated animals (pet collars; note efficacy of 
pet collars up to 365 days).
    iii. Dermal: Long-term dermal exposures from treated carpets, 
flooring, and pets (note that treated furniture is included in the 
carpet/flooring assessment).
    iv. Ingestion of granules or bait by toddlers (acute, episodic 
event).
    v. Combined short-term and intermediate-term hand-to-mouth 
exposures (toddlers):
     Treated carpet (powder application) and treated pet 
(collar/pet shampoo/pet spray).
     Treated carpet (spray application) and treated pet 
(collar/pet shampoo/pet spray).
     Treated home environment (fogger application) and treated 
pet (collar/pet shampoo/pet spray).
    vi. Combined long-term hand-to-mouth and dermal exposures 
(toddlers):
     Dermal exposure from pet hugging.
     Dermal contact with treated carpet.
     Hand-to-mouth exposures from treated carpets.
     Hand-to-mouth exposures from treated pets.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the Federal Food, Drug, and 
Cosmetic Act (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.''
    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. EPA has also evaluated 
comments submitted that suggested there might be a common mechanism 
among pyriproxyfen and other named pesticides that cause brain effects. 
EPA concluded that the evidence did not support a finding of common 
mechanism for pyriproxyfen and the named pesticides. 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

[[Page 55737]]

released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common 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 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 based on reliable data 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 factors (UFs) (safety) in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional UFs and/or special FQPA 
safety factors, as appropriate.
    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 prenatal/postnatal 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 
the 10X safety factor for infants and children should be reduced to 1X. 
The FQPA safety factor was reduced:
    i. Due to the lack of evidence of prenatal or postnatal extra 
sensitivity, or increased susceptibility in developmental studies (rats 
and rabbits), and reproduction studies (rats).
    ii. The lack of quantitative or qualitative evidence of increased 
susceptibility for rats and rabbits identified in the guideline 
prenatal developmental toxicity studies.
    iii. The lack of evidence of quantitative or qualitative increased 
susceptibility in the two non-guideline studies that evaluated 
perinatal and prenatal development.
    iv. Offspring toxicity (decreased body weight on pups during 
lactation days 14 to 21) in the reproduction toxicity study 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

    The Agency currently has two ways to estimate total aggregate 
exposure to a pesticide from food, drinking water, and residential 
uses. First, a screening assessment can be used, in which the Agency 
calculates drinking water levels of comparison (DWLOCs) which are used 
as a point of comparison against estimated environmental concentrations 
(EECs). The DWLOC values are not regulatory standards for drinking 
water, but 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 (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 EPA's 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). 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 DWOCs, EPA concluded with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposures 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 changes. When 
new uses are added EPA reassesses the potential impacts of residues of 
the pesticide in drinking water as a part of the aggregate assessment 
process.
    More recently the Agency has used another approach to estimate 
aggregate exposure through food, residential and drinking water 
pathways. In this approach, modeled surface water and ground water EECs 
are directly incorporated into the dietary exposure analysis, along 
with food. This provides a more realistic estimate of exposure because 
actual body weights and water consumption from the CSFII are used. The 
combined food and water exposures are then added to estimated exposure 
from residential sources to calculate aggregate risks. The resulting 
exposure and risk estimates are still considered to be high end, due to 
the assumptions used in developing drinking water modeling inputs.
    1. Acute risk. An acute aggregate exposure analysis was not 
conducted since no acute doses or endpoints were selected for the 
general U.S. population (including infants and children) or the females 
13-50 years old population subgroup.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
pyriproxyfen from food and water will utilize 3.2% of the cPAD for the 
U.S. population, 4.4% of the cPAD for all infants <1 year old, 9.9% of 
the cPAD for children 1-2 years old, and 2.4% of the cPAD for females 
13-49 years old.
    Chronic aggregate exposure takes into account chronic residential 
exposure plus chronic exposure to food and water. Pyriproxyfen is 
currently registered for use that could result in chronic residential 
exposure and the Agency has determined that it is appropriate to 
aggregate chronic food, water, and residential exposures for 
pyriproxyfen.
    Using the exposure assumptions described in this unit for chronic 
exposures, EPA has concluded that food, water, and residential 
exposures aggregated result in aggregate MOEs of 3,200 for the U.S. 
population; 820 for all infants <1 year old; 560 for children 1-2 years 
old; and 4,700 for females 13-49 years old. These aggregate MOEs do not 
exceed the Agency's level of concern for aggregate exposure to food and 
residential uses, as shown in the following Table 2:

[[Page 55738]]



              Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
                                                                                                      Aggregate
                                                             cPAD/mg/kg/     %cPAD/                  MOE (food +
                    Population/Subgroup                          day         (Food)     Target MOE     water +
                                                                                                    residential)
----------------------------------------------------------------------------------------------------------------
U.S. population                                                     0.35          3.2          100          3200
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old)                                           0.35          4.4          100           820
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                                            0.35          9.9          100           560
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old)                                           0.35          2.4          100          4700
----------------------------------------------------------------------------------------------------------------

    3. Short-term 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.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential 
exposures aggregated result in aggregate MOEs of 9,000 for the U.S. 
population; 1,600 for all infants <1 year old; 1,200 for children 1-2 
years old; and 1,3000 for females 13-49 years old. These aggregate MOEs 
do not exceed the Agency's level of concern for aggregate exposure to 
food and residential uses.
    4. Intermediate-term 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.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food, water, and 
residential exposures aggregated result in aggregate MOEs of 3,200 for 
the U.S. population; 560 for all infants <1 year old, 430 for children 
1-2 years old, and 4,700 for females 13-49 years old. These aggregate 
MOEs do not exceed the Agency's level of concern for aggregate exposure 
to food and residential uses.
    5. Aggregate cancer risk for U.S. population. A cancer aggregate 
risk assessment was not performed since pyriproxyfen has not been 
classified as a potential carcinogen.
    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

    In conjunction with the crop field trial studies, the petitioner 
submitted adequate concurrent recovery data for a gas chromatography/
nitrogen-phosphorus detector (GC/NPD) method (RM-33P-1-3a or 9.66 V 1) 
used to determine residues of pyriproxyfen in/on the subject crops. The 
method has undergone an adequate radiovalidation, independent 
laboratory validation (ILV) trial, petition method validation (PMV) 
trial, and has been forwarded to the Food and Drug Administration (FDA) 
for inclusion in PAM Vol. II. The GC/NPD method RM-33P-1-3a is adequate 
for enforcement of the recommended tolerance levels for residues of 
pyriproxyfen per se in/on the subject crops.

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican 
maximum residue limits (MRLs) for pyriproxyfen.

C. Response to Comments

    Several comments were received from a private citizen on objecting 
to pesticide body load, IR-4 profiteering, animal testing, establishing 
tolerances, pesticide residues, and pesticide exemptions.
    The Agency has received these same comments from this commenter of 
numerous previous occasions. Refer to the Federal Register of June 30, 
2005 (70 FR 37686) (FRL-7718-3), January 7, 2005 (70 FR 1349) (FRL-
7691-4), and October 29, 2004 (69 FR 63083) (FRL-7681-9) for the 
Agency's response to these objections.

V. Conclusion

    Therefore, tolerances are established for residues of pyriproxyfen, 
[2-[1-methyl-2-(4-phenoxyphenoxy)ethoxy]pyridine], in or on vegetable, 
legume, group 6 at 0.20 ppm; onion, dry bulb at 0.15 ppm; grape at 2.5 
ppm; strawberry at 0.30 ppm; white sapote at 0.30 ppm; citrus hybrids 
at 0.30 ppm; grass, forage,fodder, and hay, group 17, forage at 0.70 
ppm; and grass, forage, fodder, and hay, group 17, hay at 1.1 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of 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 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-2005-0246 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 November 
22, 2005.

[[Page 55739]]

    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 issue(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 (1900L), 
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 Suite 350, 1099 14th St., NW., 
Washington, DC 20005. 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 (202) 564-6255.
    2. 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 ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2005-0246, 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 ADDRESSES. 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 issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
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 104-113, 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 FFDCA, such as the tolerances 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 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.

[[Page 55740]]

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: September 19, 2005
Lois Rossi,
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), 346a and 371.

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


Sec.  180.510  Pyriproxyfen; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
              Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Citrus hybrids......................                                0.30
                                * * * * *
Grape...............................                                 2.5
Grass, forage, fodder, and hay,                                     0.70
 group 17, forage...................
Grass, forage, fodder, and hay,                                      1.1
 group 17, hay......................
                                * * * * *
Onion, dry bulb.....................                                0.15
                                * * * * *
Strawberry..........................                                0.30
                                * * * * *
Vegetable, legume, group 6..........                                0.20
                                * * * * *
White sapote........................                                0.30
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 05-19059 Filed 9-22-05; 8:45 am]
BILLING CODE 6560-50-S