[Federal Register Volume 67, Number 167 (Wednesday, August 28, 2002)]
[Rules and Regulations]
[Pages 55150-55160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-21756]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0215; FRL-7195-7]


Pyriproxyfen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for the residues of 
pyriproxyfen in or on acerola at 0.10 part per million (ppm), bushberry 
subgroup at 1.0 ppm, feijoa at 0.10 ppm, fruit, stone, group at 1.0 
ppm, guava at 0.10 ppm, jaboticaba at 0.10 ppm, juneberry at 1.0 ppm, 
lingonberry at 1.0 ppm, longan at 0.30 ppm, lychee at 0.30 ppm, 
passionfruit at 0.10 ppm, pulasan at 0.30 ppm, rambutan at 0.30 ppm, 
salal at 1.0 ppm, spanish lime at 0.30 ppm, starfruit at 0.10 ppm, and 
wax jambu at 0.10 ppm. Interregional Research Project Number 4 (IR-4) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act, as amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective August 28, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0215, 
must be received on or before October 28, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket ID number OPP-2002-0215 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; 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 affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

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

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to theFederal 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/

[[Page 55151]]

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.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0215. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of June 5, 2002 (67 FR 38660) (FRL-7177-4), 
EPA issued a notice pursuant to section 408 of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food 
Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing 
the filing of pesticide petitions (PP 1E6272, 1E6285, and 2E6353) by 
IR-4, Technology Centre of New Jersey, Rutgers University, 681 U.S. 
Highway No. 1 South, North Brunswick, NJ 08902-3390. This notice 
included a summary of the petitions prepared by Valent USA Corporation, 
the registrant. There were no comments received in response to the 
notice of filing.
    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)ethoxypyridine, in or on acerola at 
0.10 ppm, bushberry subgroup at 1.0 ppm, feijoa at 0.10 ppm, fruit, 
stone, group at 1.0 ppm, guava at 0.10 ppm, jaboticaba at 0.10 ppm, 
juneberry at 1.0 ppm, lingonberry at 1.0 ppm, longan at 0.30 ppm, 
lychee at 0.30 ppm, passionfruit at 0.10 ppm, pulasan at 0.30 ppm, 
rambutan at 0.30 ppm, salal at 1.0 ppm, spanish lime at 0.30 ppm, 
starfruit at 0.10 ppm, and wax jambu at 0.10 ppm.
    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) 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) 
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 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).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), 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), for tolerances for residues of acerola at 0.10 ppm, 
bushberry subgroup at 1.0 ppm, feijoa at 0.10 ppm, fruit, stone, group 
at 1.0 ppm, guava at 0.10 ppm, jaboticaba at 0.10 ppm, juneberry at 1.0 
ppm, lingonberry at 1.0 ppm, longan at 0.30 ppm, lychee at 0.30 ppm, 
passionfruit at 0.10 ppm, pulasan at 0.30 ppm, rambutan at 0.30 ppm, 
salal at 1.0 ppm, spanish lime at 0.30 ppm, starfruit at 0.10 ppm, and 
wax jambu at 0.10 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. The nature of the toxic effects caused by pyriproxyfen is 
discussed in Unit III.A. of the Final Rule on Pyriproxyfen Pesticide 
Tolerance published in the Federal Register of June 5, 2001 (66 FR 
30065) (FRL-6782-5). Additionally, toxicological studies to the 
toxicological profile for pyriproxyfen are shown below in Table 1:

                               Table 1.-- Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity        NOAEL = 149.4 mg/kg/day in males, 196.5 mg/
                                          rodents-mouse               kg/day in females
                                                                     LOAEL = 838.1 mg/kg/day in males, 963.9 mg/
                                                                      kg/day in females based on pathological
                                                                      changes in the kidney, increased absolute
                                                                      and relative (to body) liver weight,
                                                                      decreased red blood cell parameters (both
                                                                      sexes) and decreased body weight gain (M)
----------------------------------------------------------------------------------------------------------------
870.3265                                 28-Day inhalation toxicity- NOAEL = 0.482 mg/L (males and females)
                                          rat                        LOAEL = 1.000 mg/L based on salivation
                                                                      (both sexes), sporadic decreased body
                                                                      weight (M), and increased lactate
                                                                      dehydrogenase (M)
----------------------------------------------------------------------------------------------------------------

[[Page 55152]]

 
Non-guideline                            Special study prenatal      Parental NOAEL = 100 mg/kg/day
                                          developmental in rodents-  Parental LOAEL = 300 mg/kg/day based on
                                          rats                        clinical signs, decreased body weight
                                                                      gains, increased water consumption (both
                                                                      sexes) and increased food consumption,
                                                                      changes in organ weights, and gross
                                                                      pathological changes (M)
                                                                     Developmental NOAEL = 1,000 mg/kg/day (HDT)
----------------------------------------------------------------------------------------------------------------
Non-guideline                            Special study prenatal      Maternal NOAEL = 100 mg/kg/day
                                          developmental in rodents-  Maternal LOAEL = 300 mg/kg/day based on
                                          rats                        clinical signs, decreased body weight
                                                                      gains, and decreased food consumption
                                                                     Developmental NOAEL = 100 mg/kg/day
                                                                     Developmental LOAEL = 300 mg/kg/day based
                                                                      on decreased body weight and increased
                                                                      incidence of dilation of the renal pelvis
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Parental/systemic NOAEL = 87 mg/kg/day in
                                          effects-rat                 males, 96 mg/kg/day in females
                                                                     Parental/systemic LOAEL = 453 mg/kg/day in
                                                                      males, 498 mg/kg/day in females based on
                                                                      decreased body weight, body weight gain,
                                                                      and food consumption (both sexes) and
                                                                      increased liver weight (both sexes) and
                                                                      histopathological lesions of liver and
                                                                      kidneys (M)
                                                                     Reproductive NOAEL [ge]453 mg/kg/day in
                                                                      males, 498 mg/kg/day in females
                                                                     Reproductive LOAEL = not established
                                                                     Offspring NOAEL = 87 mg/kg/day in males, 96
                                                                      mg/kg/day in females
                                                                     Offspring LOAEL = 453 mg/kg/day in males,
                                                                      498 mg/kg/day in females based on
                                                                      decreased body weight on lactation days 14
                                                                      and 21
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity mice        NOAEL = 84 mg/kg/day in males, 109.5 mg/kg/
                                                                      day in females
                                                                     LOAEL = 420 mg/kg/day in males. 547 mg/kg/
                                                                      day in females based on renal lesions in
                                                                      males and females
                                                                     No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5265                                 Gene mutation               Non-mutagenic when tested up to 5,000 [mu]g/
                                                                      plate or cytotoxic levels, in presence and
                                                                      absence of activation, in S. typhimurium
                                                                      strains TA98, TA100, TA1535 and TA1537 and
                                                                      E.coli strain WP2uvra with 2-OH-PY
                                                                      (metabolite of pyriproxyfen)
----------------------------------------------------------------------------------------------------------------
870.5265                                 Gene mutation               Non-mutagenic when tested up to 5,000 [mu]g/
                                                                      plate or cytotoxic levels, in presence and
                                                                      absence of activation, in S. typhimurium
                                                                      strains TA98, TA100, TA1535 and TA1537 and
                                                                      E.coli strain WP2uvra with 4'-OH-PY, 5''-
                                                                      OH-PYR, DPH-PYR, POPA, and PYPAC
                                                                      (metabolites of pyriproxyfen)
----------------------------------------------------------------------------------------------------------------
870.5265                                 Gene mutation               Non-mutagenic when tested up to 5,000 [mu]g/
                                                                      plate or cytotoxic levels, in presence and
                                                                      absence of activation, in S. typhimurium
                                                                      strains TA98, TA100, TA1535 and TA1537 and
                                                                      E.coli strain WP2uvra with 2,5-OH-PY
                                                                      (metabolite of pyriproxyfen)
----------------------------------------------------------------------------------------------------------------
870.5265                                 Gene mutation               Non-mutagenic when tested up to 5,000 [mu]g/
                                                                      plate or cytotoxic levels, in presence and
                                                                      absence of activation, in S. typhimurium
                                                                      strains TA98, TA100, TA1535, TA1537, and
                                                                      TA1538 and E.coli strain WP2uvra with 2-OH-
                                                                      PY (pyriproxyfen technical)
----------------------------------------------------------------------------------------------------------------
870.5265                                 Gene mutation               Non-mutagenic at the HGPRT locus in Chinese
                                                                      hamster lung V79 cells tested up to
                                                                      cytotoxic concentrations or limit of
                                                                      solubility, in presence and absence of
                                                                      activation
----------------------------------------------------------------------------------------------------------------
870.5375                                 Chromosome aberration       Did not induce structural chromosome
                                                                      aberration in Chinese hamster ovary (CHO)
                                                                      cell cultures in the absence or presence
                                                                      of activation
----------------------------------------------------------------------------------------------------------------
870.5550                                 Unscheduled DNA synthesis   There was no evidence that unscheduled DNA
                                                                      synthesis, as determined by radioactive
                                                                      tracer procedures (nuclear silver grain
                                                                      counts) was induced in HeLa cells exposed
                                                                      up to cytotoxic levels, both in the
                                                                      presence or absence of S-9
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (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 lowest dose at which adverse effects of concern are 
identified (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

[[Page 55153]]

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 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 Safety Factor.
    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, margin of error (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 the following Table 2:

     Table 2.--Summary of Toxicological Dose and Endpoints for Pyriproxyfen for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years     None                     None                     There were no effects
 old and general population)                                                              observed in oral
                                                                                          toxicity studies
                                                                                          including
                                                                                          developmental toxicity
                                                                                          studies in rats and
                                                                                          rabbits that could be
                                                                                          attributable to a
                                                                                          single dose (acute)
                                                                                          exposure. Therefore, a
                                                                                          dose and endpoint was
                                                                                          not selected for this
                                                                                          risk assessment.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL= 35.1 mg/kg/day    FQPA SF = 1X             Subchronic toxicity and
                                       UF = 100...............  cPAD = cRfD/FQPA SF =     chronic toxicity
                                       Chronic RfD = 0.35 mg/    0.35 mg/kg/day.          (feeding) - rat (co-
                                        kg/day.                                           critical)
                                                                                         LOAEL = 141.28 mg/kg/
                                                                                          day based on decreased
                                                                                          body weight and
                                                                                          clinical pathology
                                                                                          results.
----------------------------------------------------------------------------------------------------------------
Short-term incidental, oral (1-30      Oral NOAEL = 100 mg/kg/  LOC for MOE = 100        Rat developmental
 days)                                  day                                               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)                              day                                               chronic toxicity
Residential..........................                                                     (feeding) - rat (co-
                                                                                          critical)
                                                                                         LOAEL = 141.28 mg/kg/
                                                                                          day based on decreased
                                                                                          body weight and
                                                                                          clinical pathology
                                                                                          results
----------------------------------------------------------------------------------------------------------------
Short-, and intermediate-term dermal   None                     None                     Based on the systemic
 (1-30 days and 1-6 months)                                                               toxicity NOAEL of
(Residential)........................                                                     1,000 mg/kg/day (limit
                                                                                          dose) in the 21-day
                                                                                          dermal toxicity study
                                                                                          in rats,
                                                                                          quantification of
                                                                                          dermal risks were not
                                                                                          performed. In
                                                                                          addition, no
                                                                                          developmental concerns
                                                                                          (toxicity) were seen
                                                                                          in either rats or
                                                                                          rabbits.
----------------------------------------------------------------------------------------------------------------
Long-term dermal (6 months-lifetime)   Oral NOAEL= 35.1 mg/kg/  LOC for MOE = 100        Subchronic and chronic
(Residential)........................   day                                               toxicity (feeding) -
                                       (dermal absorption rate                            rat (co-critical)
                                        = 30%).                                          LOAEL = 141.28 mg/kg/
                                                                                          day based decreased
                                                                                          body weight and
                                                                                          clinical pathology
                                                                                          results
----------------------------------------------------------------------------------------------------------------

[[Page 55154]]

 
Short-, and intermediate-term          None                     None                     Based on the absence of
 inhalation (1-30 days and 1-6                                                            significant toxicity
 months)                                                                                  at the LOAEL of 1.0 mg/
(Residential)........................                                                     L (limit dose) in the
                                                                                          28-day inhalation
                                                                                          study, the
                                                                                          quantification of
                                                                                          inhalation risks is
                                                                                          not required. In
                                                                                          addition, no
                                                                                          developmental concerns
                                                                                          (toxicity) were seen
                                                                                          in either rats or
                                                                                          rabbits.
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (6 months-        Oral study               LOC for MOE = 100        Subchronic and chronic
 lifetime)                             NOAEL = 35.1 mg/kg/day.                            toxicity (feeding) -
(Residential)........................  (inhalation absorption                             rat (co-critical)
                                        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
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

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: Almond hulls at 2.0 ppm; 
apple, pomace, wet at 0.8 ppm; citrus fruits at 0.3 ppm; citrus oil at 
20 ppm; citrus pulp, dried at 2.0 ppm; cotton, gin byproducts at 2.0 
ppm; cottonseed at 0.05 ppm; fruiting vegetables (except cucurbits) at 
0.2 ppm; pistachio at 0.02 ppm; pome fruits at 0.2 ppm; tree nuts at 
0.02 ppm; and walnuts at 0.02 ppm). Section 18s have been established 
for bean, succulent at 0.10 ppm, and stone fruits at 0.1 ppm, and are 
currently set to expire on June 30, 2003, and December 31, 2002, 
respectively. There are no livestock feed items associated with stone 
fruits, guava, lychee, blueberry, or the related crops, thus the 
proposed uses will not result in the transfer of any 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 1 day or 
single exposure. An acute dietary 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.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment, the Dietary Exposure Evaluation Model (DEEMTM) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 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 was performed using 
published and proposed tolerance levels, DEEMTM default 
processing factors, and 100% crop treated (CT) assumptions for all 
commodities.
    iii. Cancer. Pyriproxyfen was classified by EPA (June 1995) as a 
``Group E'' chemical-negative for 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 Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
Screening Concentrations in Ground Water (SCI-GROW), which predicts 
pesticide concentrations in ground water. In general, EPA will use 
GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a 
screening-level assessment for surface water. The GENEEC model is a 
subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. GENEEC incorporates a farm pond scenario, 
while PRZM/EXAMS incorporate an index reservoir environment in place of 
the previous pond scenario. The PRZM/EXAMS model includes a percent 
crop area factor as an adjustment to account for the maximum percent 
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    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 %RfD or %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

[[Page 55155]]

total aggregate exposure to pyriproxyfen, they are further discussed in 
Unit III.E.
    Pyriproxyfen is relatively long-lived in soil and water, with 
variable half-lives of approximately 2 weeks to 2 months. Pyriproxyfen 
is immobile, as indicated by the relative mobility scheme in Dragun 
(1998) for five soils and one sediment. The registrant determined the 
half-lives, 6.8 and 9 days, respectively, for the phenyl-label and 
pyridyl-label portions of pyriproxyfen. Since there is only one value, 
the longest half-life (9 days) was multiplied by 3 using the Agency's 
input guidance. Thus, the aerobic soil half-life in the modeling 
assessment was 27 days.
    EPA determined that the residues 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 ground 
water 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 ai/A, 3 times per year (citrus).
    Based on the PRZM/EXAMS model the EECs of pyriproxyfen for surface 
water was estimated to be 2.15 parts per billion (ppb) for the peak 
concentration and 0.40 ppb for the long term average. Based on the SCI-
GROW model, the EECs of pyriproxyfen for ground water was estimated to 
be 0.006 ppb for both the acute and chronic exposure.
    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).
    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 select short-term dermal or inhalation 
endpoints. Therefore, no residential pet owner/homeowner handler 
assessment is included. However, a post-application toddler residential 
assessment is included since toddlers are anticipated to have higher 
exposures than adults from treated home environments and pets due to 
their behavior patterns.
    Toddlers could potentially be exposed to pyriproxyfen residues on 
treated carpets, floors, furniture, and pets. Therefore, risk 
assessment was conducted using the following residential exposure 
assumptions:
    i. Hand-to-mouth: Short-, intermediate, and long-term hand-to-mouth 
exposures by toddlers from treated carpets, flooring (note 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; note efficacy of 
pet collars up to 395 days).
    iii. Dermal: Long-term dermal exposures from treated carpets, 
flooring, and pets (note that treated furniture is included in the 
carpet/flooring assessment). Since the Agency did not select any short- 
or intermediate-term dermal endpoints, no dermal assessment for these 
durations is included. A long-term dermal assessment is included, since 
EPA selected a long-term dermal endpoint.
    iv. Ingestion of granules or bait by toddlers (acute, episodic 
event). For the granular ingestion scenario, it should be noted that 
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 1 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) 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 or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
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 final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1.In general. FFDCA section 408 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 margin of exposure 
(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 prenatal/postnatal exposure in the 2-
generation reproduction study.

[[Page 55156]]

    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 two non-guideline studies that evaluated perinatal 
and prenatal development, there was no evidence of quantitative or 
qualitative increased susceptibility. In one 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 (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 the USEPA Office of Water are used to calculate 
DWLOCs: 2L/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 in the toxicology data base, including 
maternal toxicity in the developmental toxicity studies.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
pyriproxyfen from food will utilize 1.0% of the cPAD for the U.S. 
population, 2.0% of the cPAD for all infants, and 2.7% of the cPAD for 
children 1-6 years old. Based on the use pattern, chronic residential 
exposure to residues of pyriproxyfen is not expected. 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 water and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD, as shown in the following Table 3:

              Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                         0.35          1.0         0.40        0.006       12,000
----------------------------------------------------------------------------------------------------------------
All infants                                             0.35          2.0         0.40        0.006        3,200
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                0.35          2.7         0.40        0.006        3,100
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                               0.35          0.7         0.40        0.006       10,000
----------------------------------------------------------------------------------------------------------------

    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 and residential exposures 
aggregated result in aggregate MOEs of 29,000 for the U.S. population, 
1,800 for all infants (<1 year old), and 1,700 for children (1-6 years 
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

[[Page 55157]]

exposure of pyriproxyfen in ground water and surface water. After 
calculating DWLOCs and comparing them to the EECs for surface water and 
ground water, EPA does not expect short-term aggregate exposure to 
exceed the Agency's level of concern, as shown in the following Table 
4:

                   Table 4.--Aggregate Risk Assessment for Short-Term 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                                       29,000          100         0.40        0.006       35,000
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old)                              1,800          100         0.40        0.006        9,500
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                               1,700          100         0.40        0.006        9,400
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                             41,000          100         0.40        0.006       30,000
----------------------------------------------------------------------------------------------------------------

    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 and 
residential exposures aggregated result in aggregate MOEs of 10,000 for 
the U.S. population, 650 for all infants (<1 year old), and 620 for 
children (1-6 years 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 water and ground water, EPA does not expect 
intermediate-term aggregate exposure to exceed the Agency's level of 
concern, as shown in the following Table 5:

               Table 5.--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)
----------------------------------------------------------------------------------------------------------------
U.S. population                                     10,000          100         0.40        0.006        12,000
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old)                              650          100         0.40        0.006         3,000
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                               620          100         0.40        0.006         3,000
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                           14,000          100          0.4        0.006        10,000
----------------------------------------------------------------------------------------------------------------

    5. Aggregate cancer risk for U.S. population. The chronic toxicity 
of pyriproxyfen is based on the assessment of a combination (co-
critical) of the 90-day rat feeding study and the 2-year rat feeding 
study. There was no evidence of carcinogenicity in a 78-week mouse 
feeding study and a 2-year rat feeding study. Pyriproxyfen was 
classified as a ``Group E'' chemical (no evidence of carcinogenicity to 
humans) by the Agency on June 22, 1995, based on the absence of 
evidence of carcinogenicity in male and female rats as well as in male 
and female mice.
    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 residue studies on guava, lychee, and 
blueberry, the petitioner submitted adequate concurrent recovery data 
for a gas chromatography/nitrogen-phosphorous detector (GC/NPD) method 
(RM-33P-1-3a) used to determine residues of pyriproxyfen in/on guava, 
lychee, and blueberry. 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 Pesticide 
Analytical Method (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 guava, lychee, blueberry, and the 
related crops.
    Adequate enforcement methodology (e.g., chromotography) is 
available to enforce the tolerance expression. The method may be 
requested from: Francis Griffith, Analytical Chemistry Branch, 
Environmental Science Center, Environmental Protection Agency, 701 
Mapes Road, Fort George G. Mead, MD 20755-5350; telephone number (410) 
305-2905; [email protected].

B. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits for 
residues of pyriproxyfen in/on guava, lychee, blueberry, or the related 
crops; therefore, international harmonization is not an issue at this 
time.

[[Page 55158]]

V. Conclusion

    Therefore, the tolerances are established for residues of 
pyriproxyfen, 2-[1-methyl-2-(4-phenoxyphenoxy)ethoxypyridine, in or on 
acerola at 0.10 ppm, bushberry subgroup at 1.0 ppm, feijoa at 0.10 ppm, 
fruit, stone, group at 1.0 ppm, guava at 0.10 ppm, jaboticaba at 0.10 
ppm, juneberry at 1.0 ppm, lingonberry at 1.0 ppm, longan at 0.30 ppm, 
lychee at 0.30 ppm, passionfruit at 0.10 ppm, pulasan at 0.30 ppm, 
rambutan at 0.30 ppm, salal at 1.0 ppm, spanish lime at 0.30 ppm, 
starfruit at 0.10 ppm, and wax jambu at 0.10 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 of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
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-2002-0215 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 October 
28, 2002.
    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. 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.
    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.
    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.2. Mail your 
copies, identified by docket ID number OPP-2002-0215, 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. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. 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).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
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

[[Page 55159]]

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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 
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. Submission to Congress and the Comptroller General

    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: August 15, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

    Authority: 21 U.S.C. 321(q), 346(a) and 374.

    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
----------------------------------------------------------------------------------------------------------------
Acerola..........................................................                                           0.10
                                  *        *        *        *        *
Bushberry subgroup...............................................                                            1.0
                                  *        *        *        *        *
Feijoa...........................................................                                           0.10
                                  *        *        *        *        *
Fruit, stone, group..............................................                                            1.0
                                  *        *        *        *        *
Guava............................................................                                           0.10
Jaboticaba.......................................................                                           0.10
Juneberry........................................................                                            1.0
Lingonberry......................................................                                            1.0
Logan............................................................                                           0.30
Lychee...........................................................                                           0.30
Passionfruit.....................................................                                           0.10
                                  *        *        *        *        *
Pulasan..........................................................                                           0.30
Rambutan.........................................................                                           0.30
Salal............................................................                                            1.0
Spanish lime.....................................................                                           0.30
Starfruit........................................................                                           0.10

[[Page 55160]]

 
                                  *        *        *        *        *
Wax jambu........................................................                                           0.10
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. 02-21756 Filed 8-27-02; 8:45 am]
BILLING CODE 6560-50-S