Pyriproxyfen; Pesticide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: March 7, 2003 (Volume 68, Number 45)]
[Rules and Regulations]
[Page 10972-10982]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07mr03-10]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0345; FRL-7289-6]

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

------------------------------------------------------------------------

SUMMARY: This regulation establishes a tolerance for residues of
pyriproxyfen in or on Brassica, head and stem, subgroup 5A, Brassica,
leafy greens, subgroup 5B, vegetable, cucurbit group 9, olives and
olive oil. Valent U.S.A. Corporation requested this tolerance 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 March 7, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2002-0345,
must be received on or before May 6, 2003.

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

FOR FURTHER INFORMATION CONTACT: Joseph M. Tavano, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6411; e-mail address:
tavano.joseph@epa.gov.

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:
? Industry (NAICS 111), Crop production.
? Industry (NAICS 112), Animal production.-
? Industry (NAICS 311), Food manufacturing
? Industry (NAICS 32532), Pesticide manufacturing--
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be

[[Page 10973]]

affected by this action. Other types of entities not listed in this
unit could also be affected. The North American Industrial
Classification System (NAICS) codes have been provided to assist you
and others in determining whether this action might apply to certain
entities. If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2002-0345 The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.-
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. A frequently updated
electronic version of 40 CFR part 180 is available at http://
www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html,
a beta site currently under development. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.regulations.gov/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.

II. Background and Statutory Findings

In the Federal Register of May 29, 2002 (67 FR 37426-37432) (FRL-
7178-3), EPA issued a notice pursuant to section 408 of FFDCA, 21
U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the
filing of a pesticide petition PP 2F6385 by Valent U.S.A. Corporation,
1333 North California Blvd., Suite 600, P.O. Box 8025, Walnut Creek, CA
94596-8025. That notice included a summary of the petition prepared by
Valent U.S.A. Corporation. the registrant. There were no comments
received in response to the notice of filing.
The petition requested that 40 CFR 180.510 be amended by
establishing a tolerance for residues of the insecticide, pyriproxyfen,
2-[1-methyl-2-(4-phenoxyphenoxy)ethoxypyridine, in or on Brassica leafy
vegetables (Crop Group 5); vegetable, cucurbit (Crop Group 9); olive
and olive, oil at 2.5, 0.1, 1.0, and 3.0 parts per million (ppm)
respectively.
Based on the residue data submitted, EPA has determined that the
following changes to the requested tolerances listed in this document
are necessary. A lower tolerance of 2.0 ppm is required for olive, oil.
Brassica vegetables are devided into two subgroups. A tolerance of 0.70
is required for Brassica, head and stem, subgroup 5A. A tolerance of
2.0 ppm is required for Brassica, leafy greens, subgroup 5B.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that `` there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of the FFDCA, for a tolerance for residues of pyriproxyfen on
Brassica, head and stem, subgroup 5A; Brassica, leafy greens, subgroup
5B; Vegetable, cucurbit (Group 9); olive and olive, oil at 0.70, 2.0,
0.10, 1.0, and 2.0 ppm, respectively. EPA's assessment of exposures and
risks associated with establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by pyriproxyfen are
discussed in Table 1 of this unit as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies reviewed.

[[Page 10974]]

Table 1.--Toxicity Profile of Pyriproxyfen Technical
----------------------------------------------------------------------------------------------------------------
MRID No. (year)/
Guideline No./Study Type Classification /Doses Results
----------------------------------------------------------------------------------------------------------------
870.3100 43210504 (1990) Acceptable/ NOAEL = 149.4 mg/kg/day in males (M),
90-Day oral toxicity rodents-- mouse.... guideline 196.5 mg/kg/day in females (F)
0; 200; 1,000; 5,000; or LOAEL = 838.1 mg/kg/day (M), 963.9 mg/kg/
10,000 ppm. day (F) based on pathological changes in
M: 0, 28.2, 149.4, 838.1, the kidney, increased absolute and
or 2,034.5 milligram/ relative (to body) liver weight,
kilogram/day (mg/kg/day). decreased red blood cell parameters
F: 0, 37.9, 196.5, 963.9, (both sexes), and decreased body weight
or 2,345.3 mg/kg/day. gain (M)
-----------------------------------------
870.3100 41321716 (1989) Acceptable/ NOAEL = 23.49 mg/kg/day (M), 27.68 mg/kg/
90-Day oral toxicity rodents--rat....... guideline day (F)
0; 400; 2,000; 5,000; or LOAEL = 117.79 mg/kg/day (M), 141.28
10,000 ppm. based on increased total cholesterol and
M: 0, 23.49, 117.79, phospholipids (M),decreased red blood
309.05, or 641.81 mg/kg/ cell, hematocrit, and hemoglobin counts,
day. increased relative (to body) liver
F: 0, 27.68, 141.28, weight (M), and negative trend in red
356.30, or 783.96 mg/kg/ blood cell volume (F)
day.
-----------------------------------------
870.3150 42178307 (1988) Acceptable/ NOAEL = 100 mg/kg/day (M) and (F)
90-Day oral toxicity non-rodents--dog... guideline LOAEL = 300 mg/kg/day (M) and (F) based
0, 100, 300, or 1,000 mg/kg/ on increased absolute and relative (to
day. body) liver weight (both sexes), and
hepatocyte enlargement (F)
-----------------------------------------
870.3200 43994102 (1993) Acceptable/ NOAEL = 1,000 mg/kg/day (M) and (F)
21-Day dermal toxicity--rat............. guideline LOAEL = not established
0, 100, 300, or 1,000 mg/kg/
day.
-----------------------------------------
870.3265 42178308 (1988) NOAEL = 0.482 mg/L (M) and (F)
28-Day inhalation toxicity--rat......... Supplementary LOAEL = 1.000 mg/L based on salivation
0, 269, 482, or 1,000 mg/ (both sexes), sporadic decreased body
meter cubed (m\3\). weight (M), and increased lactate
0, 0.269, 0.482, or 1.000 dehydrogenase (M)
mg/liter (L).
-----------------------------------------
870.3700a 44985002 (1988) Acceptable/ Parental NOAEL = 100 mg/kg/day
Prenatal developmental--rats (non- nonguideline Parental LOAEL = 300 mg/kg/day based on
guideline). 0, 100, 300, 500, or 1,000 clinical signs, decreased body weight
mg/kg/day. 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
highest dose tested (HDT)
-----------------------------------------
870.3700a 44985001 (1988) Acceptable/ Maternal NOAEL = 100 mg/kg/day
Prenatal developmental--rats (non- nonguideline Maternal LOAEL = 300 mg/kg/day based on
guideline). 0, 30, 100, 300, or 500 mg/ clinical signs, decreased body weight
kg/day. 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.
-----------------------------------------
870.3700b Prenatal developmental--rabbit 41321720, 42178311, Maternal NOAEL = 100 mg/kg/day
43215401, 43215402, Maternal LOAEL = 300 mg/kg/day based on
43215403 (1989) Acceptable/ premature delivery/abortions, soft
guideline stools, emaciation, lusterless fur,
0, 100, 300, or 1,000 mg/kg/ decreased activity, and bradypnea.
day. Developmental NOAEL = 300 mg/kg/day
Developmental LOAEL = 1,000 mg/kg/day
based on decreased viable litters
available for evaluation
-----------------------------------------
870.3700a 42178312 (1988) Acceptable/ Maternal NOAEL = 100 mg/kg/day
Prenatal developmental--rat............. guideline Maternal LOAEL = 300 mg/kg/day based on
0, 100, 300, or 1,000 mg/kg/ decreased body weight, body weight gain,
day. and food consumption and increased water
consumption .
Developmental NOAEL = 300 mg/kg/day
Developmental LOAEL = 1,000 mg/kg/day
based on increased incidence of skeletal
variations at gestation day 21 and
unspecified visceral variations at
postnatal day (PND) 56.
-----------------------------------------
870.3800 42178313 (1991) Acceptable/ Parental/Systemic NOAEL = 87 mg/kg/day
Reproduction and fertility effects-- rat guideline (M), 96 mg/kg/day (F)
0; 200; 1,000; or 5,000 ppm Parental/Systemic LOAEL = 453 mg/kg/day
M: 0, 18, 87, or 453 mg/kg/ (M), 498 mg/kg/day (F) based on
day. decreased body weight, body weight gain,
F: 0, 20, 96, or 498 mg/kg/ and food consumption (both sexes) and
day. increased liver weight (both sexes) and
histopathological lesions of liver and
kidneys (M)
Reproductive NOAEL = 453 mg/kg/day (M),
498 mg/kg/day (F)
Reproductive LOAEL = not established.
Offspring NOAEL = 87 mg/kg/day (M), 96 mg/
kg/day (F)
Offspring LOAEL = 453 mg/kg/day (M), 498
mg/kg/day (F) based on decreased body
weight on lactation days 14 and 21
-----------------------------------------

[[Page 10975]]

870.4100b 42178309 (1991) Acceptable/ NOAEL = 100 mg/kg/day (M) and (F)
Chronic toxicity--dogs.................. guideline LOAEL = 300 mg/kg/day (M), 300 mg/kg/day
0, 30, 100, 300, or 1,000 (F) based on decreased body weight gain
mg/kg/day. and increased relative liver weight
(both sexes) and increased cholesterol
and triglycerides and decreased red cell
counts and hemoglobin in males
-----------------------------------------
870.4300 42178314, 43210501, NOAEL = 138 mg/kg/day (M), 35.1 mg/kg/day
Chronic/Carcinogenicity--rats........... 43210502, 43210503 (1991) (F)
Acceptable/guideline LOAEL = not established in males, 182.7
0, 120, 600, or 3,000 ppm.. mg/kg/day (F) based on decreases in body
M: 0, 5.42, 27.31, or 138.0 weight gain
mg/kg/day. No evidence of carcinogenicity
F: 0, 7.04, 35.1, or 182.7
mg/kg/day.
-----------------------------------------
870.4200 42178310 (1991) Acceptable/ NOAEL = 84 mg/kg/day (M), 109.5 mg/kg/day
Carcinogenicity--mice................... guideline (F)
0, 120, 600, or 3,000 ppm.. LOAEL = 420 mg/kg/day (M), 547 mg/kg/day
M: 0, 16.8, 84.0, or 420 mg/ (F) based on renal lesions (M) and (F)
kg/day. No evidence of carcinogenicity
F: 0, 21.9, 109.5, or 547
mg/kg/day.
-----------------------------------------
870.5265 44503506 (1995) Acceptable/ Non-mutagenic when tested up to 5,000
Gene mutation........................... guideline micrograms (mg)/plate or cytotoxic
levels, in presence and absence of
activation; in S. typhimurium strains
TA98, TA100, TA1535, and TA1537; and in
E.coli strain WP2uvra with 2-OH-PY
(metabolite of pyriproxyfen).
-----------------------------------------
870.5265 44503507 (1993) Acceptable/ Non-mutagenic when tested up to 5,000 mg/
Gene mutation........................... guideline plate or cytotoxic levels, in presence
and absence of activation; in S.
typhimurium strains TA98, TA100, TA1535,
and TA1537; and in E.coli strain WP2uvra
with 4'--OH-PY, 5'--OH-PYR, DPH-PYR,
POPA, and PYPAC (metabolites of
pyriproxyfen).
-----------------------------------------
870.5265 44503508 (1995) Acceptable/ Non-mutagenic when tested up to 5,000 mg/
Gene mutation........................... guideline plate or cytotoxic levels, in presence
and absence of activation; in S.
typhimurium strains TA98, TA100, TA1535,
and TA1537; and in E.coli strain WP2uvra
with 2,5-OH-PY (metabolite of
pyriproxyfen).
-----------------------------------------
870.5265 42178315 (1988) Acceptable/ Non-mutagenic when tested up to 5,000 mg/
Gene mutation........................... guideline plate or cytotoxic levels, in presence
and absence of activation; in S.
typhimurium strains TA98, TA100, TA1535,
TA1537, and TA1538; and in E.coli strain
WP2uvra with 2-OH-PY (pyriproxyfen
technical).
-----------------------------------------
870.5300 42178316 (1990) Acceptable/ Non-mutagenic at the HGPRT locus in
Gene mutation........................... guideline Chinese hamster lung V79 cells tested up
to cytotoxic concentrations or limit of
solubility, in presence and absence of
activation.
-----------------------------------------
870.5375 41321722 (1989) Acceptable/ Did not induce structural chromosome
Chromosome aberration................... guideline aberration in Chinese hamster ovary
(CHO) cell cultures in the absence or
presence of activation.
-----------------------------------------
870.5550 42178317 (1988) Acceptable/ There was no evidence that unscheduled
Unscheduled DNA synthesis............... guideline 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.
-----------------------------------------
870.7485Metabolism and pharmacokinetics-- 42178318 (1988) Acceptable/ Rats were orally dosed with \14\C-labeled
rat guideline pyriproxyfen at 2 or 1,000 mg/kg and at
repeated oral doses (14 daily doses) of
unlabeled pyriproxyfen at 2 mg/kg
followed by administration of a single
oral dose of labeled pyriproxyfen at 2
mg/kg. Most radioactivity was excreted
in the feces (81-92%) and urine (5-12%)
over a 7 day collection period. Expired
air containing CO₂ was not detected.
Tissue radioactivity levels were very
low (less than 0.3%) except for fat.
Examination of urine, feces, liver,
kidney, bile, and blood metabolites
yielded numerous (> 20) identified
metabolites when compared to synthetic
standards. The major biotransformation
reactions of pyriproxyfen include:
1. Oxidation of the 4'-- position of the
terminal phenyl group.
2. Oxidation at the 5'--position of
pyridine.
3. Cleavage of the ether linkage and
conjugation of the resultant phenols
with sulfuric acid.-
----------------------------------------------------------------------------------------------------------------

[[Page 10976]]

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
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 intra species 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 factors
(SF) is retained due to concerns unique to the FQPA, this additional
factor is applied to the RfD by dividing the RfD by such additional
factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is
a modification of the RfD to accommodate this type of FQPA SF.-
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
A summary of the toxicological endpoints for pyriproxyfen used for
human risk assessment is shown in Table 2 of this unit:

Table 2.--Summary of Toxicological Dose and Endpoints for pyriproxyfen for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk FQPA SF and LOC for Study and Toxicological
Exposure Scenario Assessment, UF Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary None None An appropriate endpoint
females 13-50 years old and general attributable to a
population. single oral dose was
not available in the
data base, including
maternal toxicity in
the developmental
toxicity studies.
--------------------------------------
Chronic Dietary NOAEL= 35.1 mg/kg/day FQPA SF = 1X Subchronic toxicity and
all populations...................... UF = 100............... cPAD = cRfD / FQPA SF = chronic toxicity
Chronic RfD = 0.35 mg/ 0.35 mg/kg/day. (feeding)--rat
kg/day. (co-critical)
LOAEL = 141.28 mg/kg/
day based on decreased
body weight and
clinical pathology
results.
--------------------------------------
Short-Term Incidental, Oral (1-30 Oral Maternal NOAEL = LOC for MOE = 100 Rat developmental
days) 100 mg/kg/day toxicity study
Residential.......................... Maternal 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
(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
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
(Occupational/Residential)........... day (dermal absorption toxicity (feeding)--
rate = 30%) rat
(co-critical)
LOAEL = 141.28 mg/kg/
day based decreased
body weight and
clinical pathology
results
--------------------------------------
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/
(Occupational/Residential)........... L (limit dose), 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 NOAEL= 35.1 LOC for MOE = 100 Subchronic and chronic
lifetime) mg/kg/day toxicity (feeding)--
(Occupational/Residential)........... (inhalation absorption rat
rate = 100%). (co-critical)
LOAEL = 141.28 mg/kg/
day based on decreased
body weight and
clinical pathology
results
--------------------------------------

[[Page 10977]]

Cancer (oral, dermal, inhalation) Cancer classification Risk Assessment not No evidence of
(``Group E'') required carcinogenicity
----------------------------------------------------------------------------------------------------------------
\1\ UF = uncertainty factor, FQPA SF = Food Quality Protection Act safety factor, NOAEL = no-observed-adverse-
effect-level, LOAEL = lowest-observed-adverse-effect-level, PAD = population adjusted dose (a = acute, c =
chronic) RfD = reference dose, LOC = level of concern, MOE = margin of exposure
\*\ The reference to the FQPA SF refers to any additional SF 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. 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 aRfD for females 13-50 years old and the general
population, including infants and children, was not selected because an
acute oral endpoint attributed to a single-dose exposure could not be
identified in any of the toxicology data base, including maternal
toxicity in the developmental toxicity studies. Thus, the risk from
acute exposure is considered negligible.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEM-FCID\TM\), version 1.3 analysis
evaluated the individual food consumption as reported by respondents in
the United States Department of Agricluture (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:
a. A tier 1 (assumptions: Tolerance level residues and 100 percent
crop treated (PCT) was conducted.
b. The established tolerances of 40 CFR 180.510 and the new
tolerances established in this document were included in the analysis.
c. Anticipated residues and PCT were not used in this analysis.
d. The processing factors applied were the DEEM default values.
For chronic dietary risk, EPA's level of concern is >100% cPAD.
Dietary exposure estimates for representative population subgroups are
presented in Table 3 of this unit. The results of the chronic analysis
indicate that the estimated chronic dietary risk associated with the
existing and EPA-recommended uses of pyriproxyfen is below EPA's level
of concern.

Table 3.--Summary of Results from Chronic DEEM\TM\ Analysis of
Pyriproxyfen
------------------------------------------------------------------------
Exposure
Subgroup (mg/kg/day) % cPAD
------------------------------------------------------------------------
U.S. Population (total) 0.003836 1.1
-----------------------------------------------
All Infants (< 1 year old) 0.006852 2.0
-----------------------------------------------
Children 1-2 years old 0.013707 3.9
-----------------------------------------------
Children 3-5 years old 0.010107 2.9
-----------------------------------------------
Children 6-12 years old 0.005969 1.7
-----------------------------------------------
Youth 13-19 years old 0.003389 1.0
-----------------------------------------------
Adults 20-49 years old 0.002658 0.8
-----------------------------------------------
Females 13-49 years old 0.002702 0.8
-----------------------------------------------
Adults 50+ years old 0.002676 0.8
------------------------------------------------------------------------

iii. Cancer. In accordance with the Agency's 1986 Guidelines for
Carcinogenic Risk Assessment, the RfD/Peer Review Committee classified
pyriproxyfen as a ``Group E'' chemical-negative for carcinogenicity to
humans. This classification is based on the lack of evidence of
carcinogenicity in mice and rats.
iv. Anticipated residue and PCT information. Anticipated residues
and PCT information was not used in the Agency's assessment.
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
SCI-GROW, which predicts pesticide concentrations in groundwater. 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.

[[Page 10978]]

Instead drinking water levels of comparison (DWLOCs) are calculated and
used as a point of comparison against the model estimates of a
pesticide's concentration in water. DWLOCs are theoretical upper limits
on a pesticide's concentration in drinking water in light of total
aggregate exposure to a pesticide in food, and from residential uses.
Since DWLOCs address total aggregate exposure to pyriproxyfen they are
further discussed in the aggregate risk 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 EFED input
guidance. Thus, the aerobic soil half-life in the modeling assessment
was 27 days.
EPA determined that the residue of concern in water is pyriproxyfen
per se. Drinking water estimates include surface water EDWCs based on
the linked PRZM/EXAMS models and the SCI-GROW groundwater regression
model, which was developed from studies with different hydrology and
study conditions. Both models assumed a maximum seasonal application
rate of 0.11 lb active ingredient (ai)/acre (A), 3 times per year
(citrus and stone fruit).
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 groundwater 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: Flea and tick control (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 for
pet treatments), 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, due to the lack of
toxicity observed in animal testing, no residential pet owner/homeowner
handler risk of concern is expected.
Toddlers could potentially be exposed to pyriproxyfen residues on
treated carpets, floors, furniture, and pets. There is potential for
exposure expected for the following scenarios:
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). Due to the lack of toxicity observed in
animal testing, the Agency did not select any short- or intermediate-
term dermal endpoints and no dermal risk of concern for these durations
is expected. 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 acute dietary
risk of concern is expected.
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) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether pyriproxyfen has a common mechanism of toxicity with other
substances 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. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.

[[Page 10979]]

2. Prenatal and postnatal sensitivity. Based on the available data,
there is no quantitative and qualitative evidence of increased
susceptibility observed following in utero pyriproxyfen exposure to
rats and rabbits or following pre/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
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 estimated environmental 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 EPA Office of Water are used to calculate DWLOCs:
2 L/70 kg (adult male), 2 L/60 kg (adult female), and 1 L/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 groundwater are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP 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, OPP 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 13-49 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. No acute
dietary risk is expected.
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 1.1% of the cPAD for the U.S.
population, 2.0% of the cPAD for all infant,s and 3.9% of the cPAD for
children 1-2 years old. Pyriproxyfen is the active ingredient in many
registered residential products for flea and tick control on pets and
in the home for ant and roach control for indoor and outdoor
applications. Based on the use pattern, the residential assessment was
performed for toddlers since they are anticipated to have the higher
chronic residential exposure to residues of pyriproxyfen. The total
chronic food and residential aggregate MOEs range from 850 to 13,000.
As these MOEs are greater than 100, the chronic aggregate risk does not
exceed EPA's level of concern. In addition, there is potential for
chronic dietary exposure to pyriproxyfen in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in Table 4 of this unit:

Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup Aggegate MOE (Food + Target MOE Water EEC Water EEC Chronic
Residential) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 9,200 100 0.40 0.006 12,000
====================================
All infants 1,000 100 0.40 0.006 3,200
====================================
Children 1-2 years old 860 100 0.40 0.006 3,100
====================================
Children 3-5 years old 940 100 0.40 0.006 10,000
----------------------------------------------------------------------------------------------------------------

[[Page 10980]]

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 26,000 for the U.S. population,
1,800 for all infants(<1 year old), and 1,600 for children (1-2 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
exposure of pyriproxyfen in ground and surface water. After calculating
DWLOCs and comparing them to the EECs for surface and ground water, EPA
does not expect short-term aggregate exposure to exceed the Agency's
level of concern, as shown in Table 5 of this unit:

Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup Aggregate MOE (Food + Target MOE Water EEC Water EEC Short-Term
Residential) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 26,000 100 0.40 0.006 35,000
====================================
All infants (<1 year old 1,800 100 0.40 0.006 9,400
====================================
Children (1-2 years old) 1,600 100 0.40 0.006 9,400
====================================
Females (13-49 years old) 37,000 00 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 9,200 for
the U.S. population, 650 for all infants (<1 year old, and 580 for
children (1-2 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
and surface water. After calculating DWLOCs and comparing them to the
EECs for surface and ground water, EPA does not expect intermediate-
term aggregate exposure to exceed the Agency's level of concern, as
shown in Table 6 of this unit:

Table 6.--Aggregate Risk Assessment for Intermediate-Term Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
Surface Ground Intermediate-
Population Subgroup Aggregate MOE (Food + Target MOE Water EEC Water EEC Term DWLOC
Residential) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 9,200 100 0.40 0.006 12,000
----------------------------------
All infants (<1 year old) 650 100 0.40 0.006 3,000
----------------------------------
Children (1-2 years old) 580 100 0.40 0.006 3,000
----------------------------------
Females (13-49 years old) 13,000 100 0.40 0.006 10,000
----------------------------------------------------------------------------------------------------------------

5. Aggregate cancer risk for U.S. population. 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 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 cabbage, cauliflower,
mustard greens, cantaloupe, cucumber, summer squash, olive, okra, and
sugar apple, 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 these
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 Pesticide Analytical Method (PAM)
Vol. II (DP Barcode D257337, W. Donovan, 7/1/99). HED concludes that
the GC/NPD method RM-33P-1-3a is adequate for enforcement of the
recommended

[[Page 10981]]

tolerance levels for residues of pyriproxyfen per se in/on Brassica
leafy vegetables, cucurbit vegetables, olive, okra, sugar apple,
cherimoya, atemoya, custard apple, ilama, soursop, birba, fig, avocado,
papaya, star apple, black sapote, mango, sapodilla, canistel, and mamey
sapote. As tolerances for residues of pyriproxyfen in livestock
commodities are not required at this time, enforcement methodology for
determining residues in livestock are not required.
MRM testing data have previously been provided (PP#6F04737,
DP Barcode D228556, J. Garbus, 5/6/97) for pyriproxyfen. Pyriproxyfen
was recovered from fortified apple and cotton samples through protocols
A, C, D, E, and F. The results have been forwarded to FDA.-
Adequate enforcement methodology (example--gas chromotography) is
available to enforce the tolerance expression. The method may be
requested from: Francis Griffith, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail address:
griffith.francis@epa.gov.

B. International Residue Limits

There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs) for residues of pyriproxyfen in/on any of the crops involved in
the proposed new uses. Therefore, international harmonization is not an
issue at this time.

V. Conclusion

Therefore, the tolerances are established for residues of
pyriproxyfen, [2-[1-methyl-2-(4-phenoxyphenoxy)ethoxy]pyridine], in or
on Brassica, head and stem, subgroup 5A; Brassica, leafy greens,
subgroup 5B; vegetable, cucurbit, group 9; olive and olive, oil at
0.70, 2.0, 0.10, 1.0, and 2.0 ppm.respectively.

VI. Objections and Hearing Requests

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

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

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2002-0345 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 May 6,
2003.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''

EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by telephone at (703) 305-5697, by e-mail at
tompkins.jim@epa.gov, or by mailing a request for information to: Mr.
Tompkins, Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2002-0345, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. 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

[[Page 10982]]

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. Statutory and Executive Order Reviews

This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, 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 the FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers, and food retailers, not
States. This action does not alter the relationships or distribution of
power and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of the FFDCA. For these same reasons,
the Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on Tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian Tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

Dated: February 24, 2003.
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 371.

2. Section 180.510 is amended by alphabetically adding commodities
to the table in paragraph (a)(1) to read as follows:

Sec. 180.510 Pyriproxyfen; tolerances for residues.

(a) * * *
(1) * * *

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Brassica, head and stem, subgroup 5A....................... 0.70
Brassica, leafy greens, subgroup 5B........................ 2.0
* * * * *
Olive...................................................... 1.0
Olive, oil................................................. 2.0
* * * * *
Vegetable, cucurbit, group 9............................... 0.10
* * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 03-5478 Filed 3-6-03; 8:45 am]
BILLING CODE 6560-50-S

Notices For
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
1998
1997
1996
1995
1994

Pyriproxyfen; Pesticide Tolerance

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