Pyriproxyfen; Pesticide Tolerance
[Federal Register: August 28, 2002 (Volume 67, Number 167)]
[Rules and Regulations]
[Page 55150-55160]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28au02-16]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0215; FRL-7195-7]
Pyriproxyfen; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for the residues of
pyriproxyfen in or on acerola at 0.10 part per million (ppm), bushberry
subgroup at 1.0 ppm, feijoa at 0.10 ppm, fruit, stone, group at 1.0
ppm, guava at 0.10 ppm, jaboticaba at 0.10 ppm, juneberry at 1.0 ppm,
lingonberry at 1.0 ppm, longan at 0.30 ppm, lychee at 0.30 ppm,
passionfruit at 0.10 ppm, pulasan at 0.30 ppm, rambutan at 0.30 ppm,
salal at 1.0 ppm, spanish lime at 0.30 ppm, starfruit at 0.10 ppm, and
wax jambu at 0.10 ppm. Interregional Research Project Number 4 (IR-4)
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act, as amended by the Food Quality Protection Act of 1996.
DATES: This regulation is effective August 28, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0215,
must be received on or before October 28, 2002.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0215 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: (703) 308-3194; e-mail
address: brothers.shaja@epa.gov.
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 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 
,
[[Page 55151]]
a beta site currently under
development. To access the OPPTS Harmonized Guidelines referenced in
this document, go directly to the guidelines at http://www.epa.gov/
opptsfrs/home/guidelin.htm.
2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0215. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall i2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of June 5, 2002 (67 FR 38660) (FRL-7177-4),
EPA issued a notice pursuant to section 408 of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food
Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing
the filing of pesticide petitions (PP 1E6272, 1E6285, and 2E6353) by
IR-4, Technology Centre of New Jersey, Rutgers University, 681 U.S.
Highway No. 1 South, North Brunswick, NJ 08902-3390. This notice
included a summary of the petitions prepared by Valent USA Corporation,
the registrant. There were no comments received in response to the
notice of filing.
The petitions requested that 40 CFR 180.510 be amended by
establishing tolerances for residues of the insecticide pyriproxyfen,
2-[1-methyl-2-(4-phenoxyphenoxy)ethoxypyridine, in or on acerola at
0.10 ppm, bushberry subgroup at 1.0 ppm, feijoa at 0.10 ppm, fruit,
stone, group at 1.0 ppm, guava at 0.10 ppm, jaboticaba at 0.10 ppm,
juneberry at 1.0 ppm, lingonberry at 1.0 ppm, longan at 0.30 ppm,
lychee at 0.30 ppm, passionfruit at 0.10 ppm, pulasan at 0.30 ppm,
rambutan at 0.30 ppm, salal at 1.0 ppm, spanish lime at 0.30 ppm,
starfruit at 0.10 ppm, and wax jambu at 0.10 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
these actions. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for residues of acerola at 0.10 ppm,
bushberry subgroup at 1.0 ppm, feijoa at 0.10 ppm, fruit, stone, group
at 1.0 ppm, guava at 0.10 ppm, jaboticaba at 0.10 ppm, juneberry at 1.0
ppm, lingonberry at 1.0 ppm, longan at 0.30 ppm, lychee at 0.30 ppm,
passionfruit at 0.10 ppm, pulasan at 0.30 ppm, rambutan at 0.30 ppm,
salal at 1.0 ppm, spanish lime at 0.30 ppm, starfruit at 0.10 ppm, and
wax jambu at 0.10 ppm. EPA's assessment of exposures and risks
associated with establishing these tolerances follow.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by pyriproxyfen is
discussed in Unit III.A. of the Final Rule on Pyriproxyfen Pesticide
Tolerance published in the Federal Register of June 5, 2001 (66 FR
30065) (FRL-6782-5). Additionally, toxicological studies to the
toxicological profile for pyriproxyfen are shown below in Table 1:
Table 1.-- Subchronic, Chronic, and Other Toxicity
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Guideline No. Study Type Results
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870.3100 90-Day oral toxicity NOAEL = 149.4 mg/kg/day in males, 196.5 mg/
rodents-mouse kg/day in females
LOAEL = 838.1 mg/kg/day in males, 963.9 mg/
kg/day in females based on pathological
changes in the kidney, increased absolute
and relative (to body) liver weight,
decreased red blood cell parameters (both
sexes) and decreased body weight gain (M)
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870.3265 28-Day inhalation toxicity- NOAEL = 0.482 mg/L (males and females)
rat LOAEL = 1.000 mg/L based on salivation
(both sexes), sporadic decreased body
weight (M), and increased lactate
dehydrogenase (M)
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[[Page 55152]]
Non-guideline Special study prenatal Parental NOAEL = 100 mg/kg/day
developmental in rodents- Parental LOAEL = 300 mg/kg/day based on
rats clinical signs, decreased body weight
gains, increased water consumption (both
sexes) and increased food consumption,
changes in organ weights, and gross
pathological changes (M)
Developmental NOAEL = 1,000 mg/kg/day (HDT)
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Non-guideline Special study prenatal Maternal NOAEL = 100 mg/kg/day
developmental in rodents- Maternal LOAEL = 300 mg/kg/day based on
rats clinical signs, decreased body weight
gains, and decreased food consumption
Developmental NOAEL = 100 mg/kg/day
Developmental LOAEL = 300 mg/kg/day based
on decreased body weight and increased
incidence of dilation of the renal pelvis
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870.3800 Reproduction and fertility Parental/systemic NOAEL = 87 mg/kg/day in
effects-rat males, 96 mg/kg/day in females
Parental/systemic LOAEL = 453 mg/kg/day in
males, 498 mg/kg/day in females based on
decreased body weight, body weight gain,
and food consumption (both sexes) and
increased liver weight (both sexes) and
histopathological lesions of liver and
kidneys (M)
Reproductive NOAEL [ge]453 mg/kg/day in
males, 498 mg/kg/day in females
Reproductive LOAEL = not established
Offspring NOAEL = 87 mg/kg/day in males, 96
mg/kg/day in females
Offspring LOAEL = 453 mg/kg/day in males,
498 mg/kg/day in females based on
decreased body weight on lactation days 14
and 21
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870.4300 Carcinogenicity mice NOAEL = 84 mg/kg/day in males, 109.5 mg/kg/
day in females
LOAEL = 420 mg/kg/day in males. 547 mg/kg/
day in females based on renal lesions in
males and females
No evidence of carcinogenicity
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870.5265 Gene mutation Non-mutagenic when tested up to 5,000 [mu]g/
plate or cytotoxic levels, in presence and
absence of activation, in S. typhimurium
strains TA98, TA100, TA1535 and TA1537 and
E.coli strain WP2uvra with 2-OH-PY
(metabolite of pyriproxyfen)
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870.5265 Gene mutation Non-mutagenic when tested up to 5,000 [mu]g/
plate or cytotoxic levels, in presence and
absence of activation, in S. typhimurium
strains TA98, TA100, TA1535 and TA1537 and
E.coli strain WP2uvra with 4'-OH-PY, 5''-
OH-PYR, DPH-PYR, POPA, and PYPAC
(metabolites of pyriproxyfen)
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870.5265 Gene mutation Non-mutagenic when tested up to 5,000 [mu]g/
plate or cytotoxic levels, in presence and
absence of activation, in S. typhimurium
strains TA98, TA100, TA1535 and TA1537 and
E.coli strain WP2uvra with 2,5-OH-PY
(metabolite of pyriproxyfen)
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870.5265 Gene mutation Non-mutagenic when tested up to 5,000 [mu]g/
plate or cytotoxic levels, in presence and
absence of activation, in S. typhimurium
strains TA98, TA100, TA1535, TA1537, and
TA1538 and E.coli strain WP2uvra with 2-OH-
PY (pyriproxyfen technical)
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870.5265 Gene mutation Non-mutagenic at the HGPRT locus in Chinese
hamster lung V79 cells tested up to
cytotoxic concentrations or limit of
solubility, in presence and absence of
activation
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870.5375 Chromosome aberration Did not induce structural chromosome
aberration in Chinese hamster ovary (CHO)
cell cultures in the absence or presence
of activation
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870.5550 Unscheduled DNA synthesis There was no evidence that unscheduled DNA
synthesis, as determined by radioactive
tracer procedures (nuclear silver grain
counts) was induced in HeLa cells exposed
up to cytotoxic levels, both in the
presence or absence of S-9
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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
[[Page 55153]]
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-6 or one in a million).
Under certain specific circumstances, margin of error (MOE)
calculations will be used for the carcinogenic risk assessment. In this
non-linear approach, a ``point of departure'' is identified below which
carcinogenic effects are not expected. The point of departure is
typically a NOAEL based on an endpoint related to cancer effects though
it may be a different value derived from the dose response curve. To
estimate risk, a ratio of the point of departure to exposure
(MOEcancer = point of departure/exposures) is calculated. A
summary of the toxicological endpoints for pyriproxyfen used for human
risk assessment is shown in the following Table 2:
Table 2.--Summary of Toxicological Dose and Endpoints for Pyriproxyfen for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years None None There were no effects
old and general population) observed in oral
toxicity studies
including
developmental toxicity
studies in rats and
rabbits that could be
attributable to a
single dose (acute)
exposure. Therefore, a
dose and endpoint was
not selected for this
risk assessment.
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Chronic dietary (all populations) NOAEL= 35.1 mg/kg/day FQPA SF = 1X Subchronic toxicity and
UF = 100............... cPAD = cRfD/FQPA SF = chronic toxicity
Chronic RfD = 0.35 mg/ 0.35 mg/kg/day. (feeding) - rat (co-
kg/day. critical)
LOAEL = 141.28 mg/kg/
day based on decreased
body weight and
clinical pathology
results.
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Short-term incidental, oral (1-30 Oral NOAEL = 100 mg/kg/ LOC for MOE = 100 Rat developmental
days) day toxicity study
Residential.......................... LOAEL = 300 mg/kg/day
based on decreased
body weight, body
weight gain, and food
consumption, and
increased water
consumption
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Intermediate-term incidental, oral (1- Oral NOAEL = 35.1 mg/kg/ LOC for MOE = 100 Subchronic toxicity and
6 months) day chronic toxicity
Residential.......................... (feeding) - rat (co-
critical)
LOAEL = 141.28 mg/kg/
day based on decreased
body weight and
clinical pathology
results
----------------------------------------------------------------------------------------------------------------
Short-, and intermediate-term dermal None None Based on the systemic
(1-30 days and 1-6 months) toxicity NOAEL of
(Residential)........................ 1,000 mg/kg/day (limit
dose) in the 21-day
dermal toxicity study
in rats,
quantification of
dermal risks were not
performed. In
addition, no
developmental concerns
(toxicity) were seen
in either rats or
rabbits.
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Long-term dermal (6 months-lifetime) Oral NOAEL= 35.1 mg/kg/ LOC for MOE = 100 Subchronic and chronic
(Residential)........................ day toxicity (feeding) -
(dermal absorption rate rat (co-critical)
= 30%). LOAEL = 141.28 mg/kg/
day based decreased
body weight and
clinical pathology
results
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[[Page 55154]]
Short-, and intermediate-term None None Based on the absence of
inhalation (1-30 days and 1-6 significant toxicity
months) at the LOAEL of 1.0 mg/
(Residential)........................ L (limit dose) in the
28-day inhalation
study, the
quantification of
inhalation risks is
not required. In
addition, no
developmental concerns
(toxicity) were seen
in either rats or
rabbits.
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Long-term inhalation (6 months- Oral study LOC for MOE = 100 Subchronic and chronic
lifetime) NOAEL = 35.1 mg/kg/day. toxicity (feeding) -
(Residential)........................ (inhalation absorption rat (co-critical)
rate = 100%). LOAEL = 141.28 mg/kg/
day based on decreased
body weight and
clinical pathology
results
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Cancer classification None No evidence of
(``Group E'') carcinogenicity
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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 residues of pyriproxyfen, in or on
a variety of raw agricultural commodities: Almond hulls at 2.0 ppm;
apple, pomace, wet at 0.8 ppm; citrus fruits at 0.3 ppm; citrus oil at
20 ppm; citrus pulp, dried at 2.0 ppm; cotton, gin byproducts at 2.0
ppm; cottonseed at 0.05 ppm; fruiting vegetables (except cucurbits) at
0.2 ppm; pistachio at 0.02 ppm; pome fruits at 0.2 ppm; tree nuts at
0.02 ppm; and walnuts at 0.02 ppm). Section 18s have been established
for bean, succulent at 0.10 ppm, and stone fruits at 0.1 ppm, and are
currently set to expire on June 30, 2003, and December 31, 2002,
respectively. There are no livestock feed items associated with stone
fruits, guava, lychee, blueberry, or the related crops, thus the
proposed uses will not result in the transfer of any additional
pyriproxyfen residues to livestock. Risk assessments were conducted by
EPA to assess dietary exposures from pyriproxyfen in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1 day or
single exposure. An acute dietary exposure analysis was not conducted
since no acute doses or endpoints were selected for the general U.S.
population (including infants and children) or the females 13-50 years
old population subgroup.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment, the Dietary Exposure Evaluation Model (DEEMTM)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the chronic
exposure assessments: The chronic dietary exposure was performed using
published and proposed tolerance levels, DEEMTM default
processing factors, and 100% crop treated (CT) assumptions for all
commodities.
iii. Cancer. Pyriproxyfen was classified by EPA (June 1995) as a
``Group E'' chemical-negative for carcinogenicity to humans-based on
the absence of carcinogenicity in mice and rats.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for pyriproxyfen in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of pyriproxyfen.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
Screening Concentrations in Ground Water (SCI-GROW), which predicts
pesticide concentrations in ground water. In general, EPA will use
GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a
screening-level assessment for surface water. The GENEEC model is a
subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. GENEEC incorporates a farm pond scenario,
while PRZM/EXAMS incorporate an index reservoir environment in place of
the previous pond scenario. The PRZM/EXAMS model includes a percent
crop area factor as an adjustment to account for the maximum percent
crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address
[[Page 55155]]
total aggregate exposure to pyriproxyfen, they are further discussed in
Unit III.E.
Pyriproxyfen is relatively long-lived in soil and water, with
variable half-lives of approximately 2 weeks to 2 months. Pyriproxyfen
is immobile, as indicated by the relative mobility scheme in Dragun
(1998) for five soils and one sediment. The registrant determined the
half-lives, 6.8 and 9 days, respectively, for the phenyl-label and
pyridyl-label portions of pyriproxyfen. Since there is only one value,
the longest half-life (9 days) was multiplied by 3 using the Agency's
input guidance. Thus, the aerobic soil half-life in the modeling
assessment was 27 days.
EPA determined that the residues of concern in water is
pyriproxyfen per se. Drinking water estimates include surface water
EECs based on the linked PRZM/EXAMS models and the SCI-GROW ground
water regression model, which was developed from studies with different
hydrology and study conditions. Both models assumed a maximum seasonal
application rate of 0.11 lb ai/A, 3 times per year (citrus).
Based on the PRZM/EXAMS model the EECs of pyriproxyfen for surface
water was estimated to be 2.15 parts per billion (ppb) for the peak
concentration and 0.40 ppb for the long term average. Based on the SCI-
GROW model, the EECs of pyriproxyfen for ground water was estimated to
be 0.006 ppb for both the acute and chronic exposure.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Pyriproxyfen is currently registered for use on the following
residential non-dietary sites: Residential sites for flea and tick
control products (home environment and pet treatments) as well as
products for ant and roach control (indoor and outdoor applications).
Formulations include carpet powders, foggers, aerosol sprays, liquids
(shampoos, sprays, and pipettes), granules, bait (indoor and outdoor),
and impregnated materials (pet collars).
There is a potential for short-term dermal and inhalation exposures
to pet owners and homeowners who apply products containing pyriproxyfen
(handlers); however, EPA did not select short-term dermal or inhalation
endpoints. Therefore, no residential pet owner/homeowner handler
assessment is included. However, a post-application toddler residential
assessment is included since toddlers are anticipated to have higher
exposures than adults from treated home environments and pets due to
their behavior patterns.
Toddlers could potentially be exposed to pyriproxyfen residues on
treated carpets, floors, furniture, and pets. Therefore, risk
assessment was conducted using the following residential exposure
assumptions:
i. Hand-to-mouth: Short-, intermediate, and long-term hand-to-mouth
exposures by toddlers from treated carpets, flooring (note the efficacy
of carpet powders is approximately 365 days).
ii. Hand-to-mouth: Short- and intermediate-term hand-to-mouth
exposures by toddlers from petting treated animals (shampoos, sprays,
spot-on treatments and collars). Long-term hand-to-mouth exposures by
toddlers from petting treated animals (pet collars; note efficacy of
pet collars up to 395 days).
iii. Dermal: Long-term dermal exposures from treated carpets,
flooring, and pets (note that treated furniture is included in the
carpet/flooring assessment). Since the Agency did not select any short-
or intermediate-term dermal endpoints, no dermal assessment for these
durations is included. A long-term dermal assessment is included, since
EPA selected a long-term dermal endpoint.
iv. Ingestion of granules or bait by toddlers (acute, episodic
event). For the granular ingestion scenario, it should be noted that
the Agency believes that if a toddler were to be exposed to a pellet/
granular formulation (i.e., ant bait), the event is most likely to be
``episodic,'' that is, a one time occurrence and not likely to be
repeated. It is not likely that a toddler would repeatedly locate and
ingest very small, sand colored granules. For pyriproxyfen, EPA did not
select an acute dietary endpoint, since an appropriate endpoint could
not be attributed to a single oral dose; therefore, no granular
assessment was performed.
Exposure and risk estimates from post-application exposure to
indoor crack and crevice treatments are not presented in this
assessment as indoor broadcast treatments (i.e., carpet powders and
sprays) are anticipated to have a higher exposure potential.
Additionally, the Agency acknowledges that pet owners could retreat the
home environment and/or the pet near the end of the efficacy period
identified on the product labels. However, there are no chemical-
specific residue data for pyriproxyfen to determine the dissipation
rate of residues or whether residues may be additive upon retreatment.
Therefore, a Tier 1 assessment was performed based on day 0 residues
without accounting for daily residue dissipation. EPA anticipates that
this assessment is protective as pyriproxyfen residues would be
expected to dissipate from day 0 residue values.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether pyriproxyfen has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
pyriproxyfen does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that pyriproxyfen has a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
D. Safety Factor for Infants and Children
1.In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. Based on the available data,
there is no quantitative and qualitative evidence of increased
susceptibility observed following in utero pyriproxyfen exposure to
rats and rabbits or following prenatal/postnatal exposure in the 2-
generation reproduction study.
[[Page 55156]]
3. Conclusion. There is a complete toxicity data base for
pyriproxyfen and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X safety factor to protect infants and children should be
reduced to 1X because there was no evidence of prenatal or postnatal
extra sensitivity or increased susceptibility in developmental studies
in rats and rabbits, and in reproduction studies in rats. Likewise,
there was no quantitative or qualitative evidence of increased
susceptibility to rat or rabbit fetuses identified in the guideline
prenatal developmental toxicity studies for rats and rabbits.
Additionally, in the two non-guideline studies that evaluated perinatal
and prenatal development, there was no evidence of quantitative or
qualitative increased susceptibility. In one study, when pregnant rats
were treated from gestation day 17 to lactation day 20, the resulting
toxicity was comparable between adults (clinical signs, decreased body
weight gain and food consumption) and offspring (decreased body weight
and dilation of the renal pelvis) at the same dose. In the other study,
when rats were exposed to pyriproxyfen prior to and in the early stages
of pregnancy, no developmental toxicity was seen at the limit dose.
Lastly, in the reproduction toxicity study, offspring toxicity
(decreased body weight on pups during lactation days 14 to 21) occurred
only in the presence of decreases in body weight in parental animals at
the same dose level (i.e., comparable toxicity in adults and
offspring).
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water EECs. DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water (e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. An acute dietary RfD for females 13-50 and the
general U.S. population, including infants and children, was not
selected because an acute oral endpoint attributable to a single-dose
exposure could not be identified in the toxicology data base, including
maternal toxicity in the developmental toxicity studies.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
pyriproxyfen from food will utilize 1.0% of the cPAD for the U.S.
population, 2.0% of the cPAD for all infants, and 2.7% of the cPAD for
children 1-6 years old. Based on the use pattern, chronic residential
exposure to residues of pyriproxyfen is not expected. In addition,
there is potential for chronic dietary exposure to pyriproxyfen in
drinking water. After calculating DWLOCs and comparing them to the EECs
for surface water and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the cPAD, as shown in the following Table 3:
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.35 1.0 0.40 0.006 12,000
----------------------------------------------------------------------------------------------------------------
All infants 0.35 2.0 0.40 0.006 3,200
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 0.35 2.7 0.40 0.006 3,100
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 0.35 0.7 0.40 0.006 10,000
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Pyriproxyfen is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for pyriproxyfen.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 29,000 for the U.S. population,
1,800 for all infants (<1 year old), and 1,700 for children (1-6 years
old). These aggregate MOEs do not exceed the Agency's level of concern
for aggregate exposure to food and residential uses. In addition,
short-term DWLOCs were calculated and compared to the EECs for chronic
[[Page 55157]]
exposure of pyriproxyfen in ground water and surface water. After
calculating DWLOCs and comparing them to the EECs for surface water and
ground water, EPA does not expect short-term aggregate exposure to
exceed the Agency's level of concern, as shown in the following Table
4:
Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 29,000 100 0.40 0.006 35,000
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old) 1,800 100 0.40 0.006 9,500
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 1,700 100 0.40 0.006 9,400
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 41,000 100 0.40 0.006 30,000
----------------------------------------------------------------------------------------------------------------
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Pyriproxyfen is currently registered for use(s) that could result
in intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and
intermediate-term exposures for pyriproxyfen.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 10,000 for
the U.S. population, 650 for all infants (<1 year old), and 620 for
children (1-6 years old). These aggregate MOEs do not exceed the
Agency's level of concern for aggregate exposure to food and
residential uses. In addition, intermediate-term DWLOCs were calculated
and compared to the EECs for chronic exposure of pyriproxyfen in ground
water and surface water. After calculating DWLOCs and comparing them to
the EECs for surface water and ground water, EPA does not expect
intermediate-term aggregate exposure to exceed the Agency's level of
concern, as shown in the following Table 5:
Table 5.--Aggregate Risk Assessment for Intermediate-Term Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Intermediate-
Population Subgroup MOE (Food + Concern Water EEC Water EEC Term DWLOC
Residential) (LOC) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 10,000 100 0.40 0.006 12,000
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old) 650 100 0.40 0.006 3,000
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 620 100 0.40 0.006 3,000
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 14,000 100 0.4 0.006 10,000
----------------------------------------------------------------------------------------------------------------
5. Aggregate cancer risk for U.S. population. The chronic toxicity
of pyriproxyfen is based on the assessment of a combination (co-
critical) of the 90-day rat feeding study and the 2-year rat feeding
study. There was no evidence of carcinogenicity in a 78-week mouse
feeding study and a 2-year rat feeding study. Pyriproxyfen was
classified as a ``Group E'' chemical (no evidence of carcinogenicity to
humans) by the Agency on June 22, 1995, based on the absence of
evidence of carcinogenicity in male and female rats as well as in male
and female mice.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to pyriproxyfen residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
In conjunction with the residue studies on guava, lychee, and
blueberry, the petitioner submitted adequate concurrent recovery data
for a gas chromatography/nitrogen-phosphorous detector (GC/NPD) method
(RM-33P-1-3a) used to determine residues of pyriproxyfen in/on guava,
lychee, and blueberry. The method has undergone an adequate
radiovalidation, independent laboratory validation (ILV) trial,
petition method validation (PMV) trial, and has been forwarded to the
Food and Drug Administration (FDA) for inclusion in Pesticide
Analytical Method (PAM) Vol. II. The GC/NPD method RM-33P-1-3a is
adequate for enforcement of the recommended tolerance levels for
residues of pyriproxyfen per se in/on guava, lychee, blueberry, and the
related crops.
Adequate enforcement methodology (e.g., chromotography) is
available to enforce the tolerance expression. The method may be
requested from: Francis Griffith, Analytical Chemistry Branch,
Environmental Science Center, Environmental Protection Agency, 701
Mapes Road, Fort George G. Mead, MD 20755-5350; telephone number (410)
305-2905; griffith.francis@epa.gov.
B. International Residue Limits
There are no Codex, Canadian, or Mexican maximum residue limits for
residues of pyriproxyfen in/on guava, lychee, blueberry, or the related
crops; therefore, international harmonization is not an issue at this
time.
[[Page 55158]]
V. Conclusion
Therefore, the tolerances are established for residues of
pyriproxyfen, 2-[1-methyl-2-(4-phenoxyphenoxy)ethoxypyridine, in or on
acerola at 0.10 ppm, bushberry subgroup at 1.0 ppm, feijoa at 0.10 ppm,
fruit, stone, group at 1.0 ppm, guava at 0.10 ppm, jaboticaba at 0.10
ppm, juneberry at 1.0 ppm, lingonberry at 1.0 ppm, longan at 0.30 ppm,
lychee at 0.30 ppm, passionfruit at 0.10 ppm, pulasan at 0.30 ppm,
rambutan at 0.30 ppm, salal at 1.0 ppm, spanish lime at 0.30 ppm,
starfruit at 0.10 ppm, and wax jambu at 0.10 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2002-0215 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before October
28, 2002.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket ID number OPP-2002-0215, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: 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 uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income
[[Page 55159]]
Populations (59 FR 7629, February 16, 1994); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Since tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerance in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism(64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of FFDCA section 408(n)(4).
For these same reasons, the Agency has determined that this rule does
not have any ``tribal implications'' as described in Executive Order
13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 15, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 374.
2. Section 180.510 is amended by alphabetically adding the
following commodities to the table in paragraph (a) to read as follows:
Sec. 180.510 Pyriproxyfen; tolerances for residues.
(a) * * *
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
Acerola.......................................................... 0.10
* * * * *
Bushberry subgroup............................................... 1.0
* * * * *
Feijoa........................................................... 0.10
* * * * *
Fruit, stone, group.............................................. 1.0
* * * * *
Guava............................................................ 0.10
Jaboticaba....................................................... 0.10
Juneberry........................................................ 1.0
Lingonberry...................................................... 1.0
Logan............................................................ 0.30
Lychee........................................................... 0.30
Passionfruit..................................................... 0.10
* * * * *
Pulasan.......................................................... 0.30
Rambutan......................................................... 0.30
Salal............................................................ 1.0
Spanish lime..................................................... 0.30
Starfruit........................................................ 0.10
[[Page 55160]]
* * * * *
Wax jambu........................................................ 0.10
----------------------------------------------------------------------------------------------------------------
* * * * *
[FR Doc. 02-21756 Filed 8-27-02; 8:45 am]
BILLING CODE 6560-50-S
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