[Federal Register Volume 66, Number 108 (Tuesday, June 5, 2001)]
[Rules and Regulations]
[Pages 30065-30073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14085]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301131; FRL-6782-5]
RIN 2070-AB78
Pyriproxyfen; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
pyriproxyfen in or on pistachio. The Interregional Research Project
Number 4 (IR-4) requested this tolerance under the Federal Food, Drug,
and Cosmetic Act, as amended by the Food Quality Protection Act of
1996.
DATES: This regulation is effective June 5, 2001. Objections and
requests for hearings, identified by docket control number OPP-301131,
must be received by EPA on or before August 6, 2001.
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 control number OPP-301131 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Hoyt Jamerson, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460;
telephone number: (703) 308-9368; and e-mail address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
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Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up
[[Page 30066]]
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/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 control number OPP-301131. 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 April 4, 2001 (66 FR 17883) (FRL-6772-
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 a pesticide petition (PP 0E6081) for tolerance by IR-4,
Technology Center of New Jersey, Rutgers, The State University of New
Jersey, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390. This
notice included a summary of the petition prepared by Valent U.S.A.
Corporation, 1333 North California Blvd., P.O. Box 8025, Walnut Creek,
CA 94596-8025, 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 pistachio at
0.02 part per million (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
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), for a tolerance for residues of pyriproxyfen on pistachio at
0.2 ppm. 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 the following Table 1 as well as the no observed adverse
effect level (NOAEL) and the lowest observed adverse effect level
(LOAEL) from the toxicity studies reviewed.
Table 1.--Subchronic, Chronic, and Other Toxicity
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Guideline No. Study Type Results
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870.3100 Subchronic feeding in rats NOAEL = 23.49 mg/kg/day in males 27.68 mg/
(13 weeks) kg/day in females
LOAEL = 117.79 milligram/kilogram/day (mg/
kg/day) in males and 141.28 mg/kg/day in
females based on higher mean total
cholesterol and phospholipids; decreased
mean red blood cells, hematocrit and
hemoglobin counts and increased liver
weight.
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870.3150 Subchronic oral toxicity in NOAEL = 100 mg/kg/day
dogs (13 weeks) LOAEL = 300 mg/kg/day based on increased
absolute and relative liver weight in
males and hepatocellular hypertrophy in
females. These findings were also
observed at 1,000 mg/kg/day and may
represent adaptive changes at both 300
mg/kg/day and the limit dose of 1,000 mg/
kg/day.
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870.3200 21-Day dermal toxicity NOAEL = >1,000 mg/kg/day
(rat) There was no dermal or systemic toxicity
at the 1,000 mg/kg/day dose, highest
dose tested (HDT).
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[[Page 30067]]
870.3700a Prenatal developmental Maternal NOAEL = 100 mg/kg/day
(rat) LOAEL = 300 mg/kg/day based on increased
incidences in mortality and clinical
signs at 1,000 mg/kg/day with decreases
in food consumption, body weight, and
body weight gain together with increases
in water consumption at 300 and 1,000 mg/
kg/day.
Developmental NOAEL = 300 mg/kg/day
LOAEL = 1,000 mg/kg/day based on
increased incidences of skeletal
variations and unspecified visceral
variations at 1,000 mg/kg/day.
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870.3700b Prenatal developmental Maternal NOAEL = 100 mg/kg/day
(rabbit) LOAEL = 300 mg/kg/day based on based on
premature delivery/abortions, soft
stools, emaciation, decreased activity
and bradypnea.
Developmental NOAEL = 300 mg/kg/day
LOAEL = 1,000 mg/kg/day. There were no
effects observed in the 4 litters
examined.
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870.3800 Reproduction and fertility Parental/systemic NOAEL = 76 mg/kg/day in
effects (rat) males and 87 mg/kg/day in females
LOAEL = 386 mg/kg/day and males 442mg/kg/
day in females based on decreased body
weight, weight gain and food consumption
in both sexes and both generations.
Increased liver weight in both sexes of
the F1 generation and liver and kidney
histopathology in F1 males.
Reproductive NOAEL = 386 mg/kg/day in
males and 442 mg/kg/day in females
(highest dose tested).
Offspring NOAEL = 97 mg/kg/day in males
and 105 mg/kg/day in females
LOAEL = 519 mg/kg/day in males and 554 mg/
kg/day in females based on decreased pup
body weight on lactation.
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870.3800 Perinatal and postnatal Maternal NOAEL: 100 mg/kg/day
study of pyriproxyfen Maternal LOAEL: 300 mg/kg/day based on
orally administered to increased clinical signs, decreased body
rats weight gains, and decreased food
consumption
Pup NOAEL: 100 mg/kg/day
Pup LOAEL: 300 mg/kg/day based on
decreased body weight and increased
incidence of dilation of the renal
pelvis. At 500 mg/kg/day, there was an
increase in pup mortality during
lactation
Pup Reproductive, Developmental, and
Learning
NOAEL: 500 mg/kg/day
LOAEL: 500 mg/kg/day
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870.3800 Non-guideline study of rats Parental NOAEL = 100 mg/kg/day
orally exposed prior to Parental LOAEL = 300 mg/kg/day based on
and in the early stages of increased clinical signs, decreased body
pregnancy weight gains, and increased water
consumption in both sexes, and increased
food consumption, changes in organ
weights, and gross pathological findings
in the males only.
Developmental NOAEL = 1,000 mg/kg/day
Developmental LOAEL = 1,000 mg/kg/day
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870.4300 Chronic toxicity/ NOAEL = 35.1 mg/kg/day (females)
oncogenicity (rat) LOAEL = 182.7 mg/kg/day (females) based
on decrease in body weight gain in
females at 182.70 mg/kg/day. There was
no evidence of carcinogenic response.
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870.4100 1-Year chronic feeding NOAEL = 100 mg/kg/day
(dog) LOAEL = 300 mg/kg/day based on decreased
weight gain, increased absolute and
relative liver weight, mild anemia,
increased cholesterol and triglycerides
in both sexes and slight anemia in
males.
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870.4200 Carcinogenicity mice NOAEL = 84 mg/kg/day in males and 109 mg/
kg/day in females
LOAEL = 320 mg/kg/day in males and 547 mg/
kg/day in females based on renal lesions
in both sexes. No statistically
significant increase in tumor incidence
relative to controls were observed in
either sex at any dose up to the highest
dose tested.
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870.5100 Gene Mutation Assay (Ames Negative for induction of gene mutation
Test) Reverse Mutation measured as the reversion to histidine
protrophy of 5 S. typhimurium strains
and E. coli WP2 uvra at doses from 10 to
5,000 g/plated with and withour
S-9 activation.
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870.5300 Gene Mutation Negative for induction of gene mutation
in Chinese hamster V79 cells with and
without metabolic activation up to
cytotoxic doses.
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[[Page 30068]]
870.5380 Structural Nonclastogenic in Chinese hamster ovary
ChromosomalAbberation In cells both with and without S-9
vivo activation up to cytotoxic doses.
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870.5550 Unscheduled DNA Synthesis Did not induce an increase in unscheduled
DNA synthesis both with and without
activation in HeLa cells exposed up to
insoluble doses ranging to 6.4 g/mL without activation and 51.2
g/mL with activation.
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870.7485 Metabolism Rats were orally dosed with 14C-labeled
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
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.
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870.7600 Dermal penetration
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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 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, 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 (MOE cancer = 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
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FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
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Acute dietary all populations Not applicable Not applicable No effects that could
be attributed to a
single exposure were
observed in oral
toxicity studies.
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Chronic dietary all populations NOAEL= 35.1 mg/kg/day FQPA SF = 1X 2-Year chronic feeding
UF = 100............... cPAD = chronic RfD study in rats
Chronic RfD = 0.35 mg/ FQPA SF. LOAEL = 182.7 mg/kg/day
kg/day. =0.35 mg/kg/day........ based on a decrease in
body weight gains in
females.
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[[Page 30069]]
Short-term dermal and inhalation (1 Not applicable Not applicable 21-Day dermal toxicity
to 7 days) (residential) Absorption rate = not study lack of dermal
more than 10%. or systemic toxicity
at the limit-dose of
1,000 mg/kg/day.
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Intermediate-term dermal and Not applicable Not applicable 21-Day dermal toxicity
inhalation (1 week to several Absorption rate = not study
months) (residential) more than 10%. Lack of dermal or
systemic toxicity at
the limit-dose of
1,000 mg/kg/day.
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Long-term dermal and inhalation 35.1 mg/kg/day LOC for MOE = 100 Chronic toxicity/
(several months to lifetime) (residential).......... carcinogenicity in
(residential)........................ rats
LOAEL = 182.7 mg/kg/day
based on decreased
weight gain in female
rats.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) ``Group E'' human Not applicable There is no evidence of
carcinogen carcinogenic
potential.
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*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 combined residues of pyriproxyfen,
in or on a variety of raw agricultural commodities. Permanent
tolerances are established under 40 CFR 180.510(a) for residues of
pyriproxyfen in/on the following commodities: pome fruits (crop group
11) (0.2 ppm), citrus fruits (crop group 10) (0.3 ppm), fruiting
vegetables (except cucurbits) (crop group 8) (0.2 ppm), tree nuts (crop
group 14) (0.02 ppm), cotton seed (0.05 ppm), cotton gin byproducts
(2.0 ppm), almond hulls (2.0 ppm), citrus oil (20 ppm), and citrus
pulp, dried (2.0 ppm). Tolerances are also proposed by McLaughlin
Gormley King Company for residues of pyriproxyfen in/on all food
commodities at 0.10 ppm from use of the pesticide in food handling
establishments. 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 dose and endpoint were not selected for any
population subgroup because no effects that could be attributed to a
single exposure were observed in oral toxicity studies. Therefore, an
acute exposure assessment was not conducted.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM) 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 analysis for pyriproxyfen
assumed tolerance level residues and 100% crop treated for all
commodities with established or proposed tolerances.
iii. Cancer. A cancer dietary exposure assessment was not performed
since there was no evidence of carcinogenicity in studies conducted
with rats and mice.
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 total aggregate exposure to pyriproxyfen they are
further discussed in the aggregate risk sections below.
Based on the PRZM/EXAMS and SCI-GROW models, the EECs of
pyriproxyfen for acute exposures are estimated to be 0.46 parts per
billion (ppb) for surface water and 0.006 ppb for ground water. The
EECs for chronic
[[Page 30070]]
exposures are estimated to be 0.11 ppb for surface water and 0.006 ppb
for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Pyriproxyfen is currently registered for use on residential non-
dietary sites. Pyriproxyfen is the active ingredient in many registered
residential (indoor, nonfood) products for flea and tick control.
Formulations include foggers, aerosol sprays, emulsifiable concentrates
and impregnated materials (pet collars). Pyriproxyfen residues from
residential exposure to pet collars was estimated using the following
assumptions: an application rate of 0.58 mg ai/day (product label),
average body weight for a 1 to 6-year old child of 10 kg, the active
ingredient dissipates uniformly through 365 days (the label instructs
to change the collar once a year), and 1% of the active ingredient is
available for dermal and inhalation exposure per day (assumption from
Draft HED Standard Operating Procedures (SOPs) for Residential Exposure
Assessments, December 18, 1997). The assessment also assumes an
absorption rate of 100%. This is a conservative assumption since the
dermal absorption was estimated to be 10%.
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. Safety factor for infants and children--i. 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.
ii. Prenatal and postnatal sensitivity. There is no indication of
increased susceptibility of rats or rabbit fetuses to in utero and/or
postnatal exposure in the developmental and reproductive toxicity
studies.
iii. 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
removed (reduced to 1X). The FQPA factor is removed because: (1) The
toxicology data base is complete; (2) there is no indication of
increased susceptibility of rats or rabbit fetuses to in utero and/or
postnatal exposure in the developmental and reproductive toxicity
studies; (3) a developmental neurotoxicity study is not required; (4)
dietary (food) exposure estimates are unrefined (assuming tolerance
level residues and 100% crop treated) and likely result in an
overestimate of the actual dietary exposure; (5) the models are used
for ground and surface source drinking water exposure assessments
result in estimates that are upper-bound concentrations; and (6) the
Draft Standard Operating Procedures for Residential Exposure
Assessments have been used as the basis for all calculations which
normally rely on one or more upper-percentile assumptions and are
considered to be protective.
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, 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 dose and endpoint was not
identified. Thus the risk from acute aggregate exposure is considered
to be negligible.
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 0.9% of the cPAD for the U.S.
population, 1.6 % of the cPAD for all infants (< year) and 2.6% of the
cPAD for children (1-6 years). With the exception of the pet collar
uses, residential uses of pyriproxyfen result in short-term,
intermittent exposures. Chronic residential postapplication risk
[[Page 30071]]
assessments were conducted to estimate the potential risk from the pet
collar uses. The estimated chronic term MOE is 61,000 for children and
430,000 for adults. The risk estimates indicate that potential risks
from pet collar use do not exceed EPA level of concern (MOEs> 100). 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 the
following Table 3:
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Pyriproxyfen
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface Water EEC Ground Water EEC Chronic DWLOC
Population Subgroup cPAD mg/kg/day %cPAD (Food) (ppb) (ppb) (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population 0.35 0.9% 0.11 0.006 12,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
All Infants (<1 year) 0.35 1.6% 0.11 0.006 3,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-6 years) 0.35 2.6% 0.11 0.006 3,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-50 years) 0.35 0.7% 0.11 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). Though residential
exposure could occur with the use of pyriproxyfen, no toxicological
effects have been identified for short-term toxicity. Therefore, the
aggregate risk is the sum of the risk from food and water, which do not
exceed the Agency's level of concern.
4. Aggregate cancer risk for U.S. population. Pyriproxyfen is
classified as Group E for human carcinogenicity; not carcinogenic in
animal studies in two species.
5. 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
The gas-chromotography/nitrogen-phosphorous specific flame
ionization detector (NPD) and high-pressure liquid chromotography/
fluorescence (FLD) method RM-33N-2 is adequate for collecting data on
residues of pyriproxyfen in/on nutmeat. Adequate method validation data
have been submitted for this method and EPA has successfully validated
the analytical method for analysis of nutmeat. The limit of
quantitation (LOQ) is 0.02 ppm for residues of pyriproxyfen in/on
nutmeat.
The method may be requested from: Calvin Furlow, PIRIB, IRSD
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number:
(703) 305-5229; e-mail address: [email protected].
B. International Residue Limits
There are no CODEX, Canadian, or Mexican tolerances for
pyriproxyfen residues in/on pistachios. Therefore, international
harmonization is not an issue at this time.
V. Conclusion
Therefore, the tolerance is established for residues of
pyriproxyfen in or on pistachio at 0.02 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 control number OPP-301131 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 August 6,
2001.
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 (1900),
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. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
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
[[Page 30072]]
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 control number OPP-301131, 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). 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 special considerations as required by Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994); or require 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).
[[Page 30073]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 17, 2001.
James Jones,
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 revising the introductory text in
paragraph (a)(1) and alphabetically adding the commodity ``pistachio''
to the table to read as follows:
Sec. 180.510 Pyriproxyfen; tolerances for residues.
(a) General. (1) Tolerances are established for residues of the
insecticide pyriproxyfen 2-[1-methyl-2-(4-phenoxyphenoxy)ethoxypyridine
in or on the following food commodities:
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
* * * * *
Pistachio........................................................ 0.02
* * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
[FR Doc. 01-14085 Filed 6-4-01; 8:45 am]
BILLING CODE 6560-50-S