[Federal Register: May 14, 2003 (Volume 68, Number 93)]
[Rules and Regulations]
[Page 25831-25837]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14my03-12]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0109; FRL-7305-9]
Pyriproxyfen; Pesticide Tolerances
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 atemoya, biriba, cherimoya, custard apple, ilama,
soursop, and sugar apple at 0.20 parts per million (ppm); avocado,
black sapote, canistel, mamey sapote, mango, papaya, sapodilla and star
apple at 1.0 ppm; okra at 0.02 ppm; fig at 0.30 ppm; and fig, dried at
1.0 ppm. The Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective May 14, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0109,
must be received on or before July 14, 2003.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Hoyt Jamerson, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone
number: (703) 308-9368; e-mail address: jamerson.hoyt@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
[sbull] Crop production (NAICS 111)
[sbull] Animal Production (NAICS 112)
[sbull] Food manufacturing (NAICS 311)
[sbull] Pesticide manufacturing (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0109. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. A frequently updated
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html
, a
beta site currently under development. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of March 7, 2003 (68 FR 11093) (FRL-7289-
8), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, as amended by FQPA (Public Law 104-170), announcing the filing of
pesticide petitions (PP) 2E6416, 2E6425, 2E6428, and 2E6436) by IR-4,
681 US Highway 1 South, North Brunswick, NJ 08902-3390. That
notice included a summary of the petitions prepared by Valent U.S.A.
Corporation, the registrant. There were no comments received in
response to the notice of filing.
The petition requested that 40 CFR 180.510 be amended by
establishing tolerances for residues of the insecticide pyriproxyfen,
2-[1-methyl-2-(4-phenoxyphenoxy)ethoxy]pyridine, in or on atemoya,
biriba, cherimoya, custard apple, ilama, soursop, and sugar apple at
0.20 ppm (PP 2E6416); avocado, black sapote, canistel, mamey sapote,
mango, papaya, sapodilla and star apple at 1.0 ppm (PP 2E6428); okra at
0.02 ppm (PP 2E6436); fig at 0.30 ppm (PP 2E6425); and fig, dried at
1.0 ppm (2E6425).
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
[[Page 25832]]
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of the FFDCA, for tolerances for residues of pyriproxyfen on
atemoya, biriba, cherimoya, custard apple, ilama, soursop, and sugar
apple at 0.20 ppm (PP 2E6416); avocado, black sapote, canistel, mamey
sapote, mango, papaya, sapodilla and star apple at 1.0 ppm (PP 2E6428);
okra at 0.02 ppm (PP 2E6436); fig at 0.30 ppm (PP 2E6425); and fig,
dried at 1.0 ppm (2E6425). EPA's assessment of exposures and risks
associated with establishing the tolerances 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 no observed adverse effect level (NOAEL) and the lowest
observed adverse effect level (LOAEL) from the toxicity studies
reviewed as well as the nature of the toxic effects caused by
pyriproxyfen are discussed in Unit III.A. of the Federal Registers of
June 5, 2001 (66 FR 30065) (FRL-6782-5), August 28, 2002 (67 FR 55150)
(FRL-7195-7), and March 7, 2003 (68 FR 10972) (FRL-7289-6).
B. Toxicological Endpoints
The dose at which 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 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 (SF)
is retained due to concerns unique to the FQPA, this additional factor
is applied to the RfD by dividing the RfD by such additional factor.
The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA SF.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
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 (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for pyriproxyfen used for human risk assessment is shown in
Unit III.B. of the Federal Register of March 7, 2003 (68 FR 10972).
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. There are no significant
livestock feed items associated this action, thus the proposed uses
will not result in the transfer of 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 one day
or single exposure. An acute dietary exposure analysis was not
conducted since no acute doses or toxicological 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 EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID[reg]) which incorporates
food consumption data as reported by respondents in the USDA 1994-1996
and 1998 nationwide Continuing Surveys of Food Intake by Individuals
(CSFII) and accumulated exposure to the chemical for each commodity.
The following assumptions were made for the chronic exposure
assessments: The chronic dietary exposure assessment was performed
using published and proposed tolerance levels, DEEM[reg] default
processing factors, and 100% crop treated (PCT) assumptions for all
commodities. Some of the crops (atemoya, custard apple, ilama, birba,
sapodilla, black and white sapote, star apple, and ugli fruit)
considered in this risk assessment are not included in the present
version of DEEM-FCID[reg] due to their low consumption. In these cases,
the DEEM-FCID[reg] program underestimates the exposure to pyriproxyfen
residues from these crops; however, because the consumption levels of
these crops is so low (on a national basis), inclusion of these crops
in a future version of DEEM-FCID[reg] would likely make no difference
in the overall predicted exposures to pyriproxyfen residues.
iii. Cancer. Pyriproxyfen was classified by the EPA (June, 1995) as
a ``Group E'' chemical - no evidence of 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 FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of
[[Page 25833]]
pesticide concentrations in an index reservoir. The screening
concentration in ground water (SCI-GROW) model is used to predict
pesticide concentrations in shallow ground water. For a screening-level
assessment for surface water EPA will use FIRST (a Tier I model) before
using PRZM/EXAMS (a Tier II model). The FIRST model is a subset of the
PRZM/EXAMS model that uses a specific high-end runoff scenario for
pesticides. FIRST and PRZM/EXAMS incorporate an index reservoir
environment, and a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
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 percent reference dose (%RfD) or
percent population adjusted dose (%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 in Unit III.E.
EPA determined that the residue 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 regression model, which
was developed from studies with different hydrology and study
conditions. Both models assumed a maximum seasonal application rate of
0.11 lb active ingredient per acre, applied 3 times per year. (The
registered use for citrus). Based on the PRZM/EXAMS and SCI-GROW models
the EECs of pyriproxyfen for acute exposures are estimated to be 2.15
parts per billion (ppb) for surface water and 0.006 ppb for ground
water. The EECs for chronic exposures are estimated to be 0.40 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 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).
The risk assessment was conducted using the following residential
exposure assumptions: 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 identify any
short-term dermal or inhalation endpoints. Because no short-term dermal
or inhalation endpoints could be identified, EPA expects no short-term
dermal or inhalation risks from exposure to pyriproxyfen. There is also
a potential for non-dietary oral exposures (hand-to-mouth exposures)
and dermal exposure following applications around the home and on pets
for flea and tick control (carpet powder and pet shampoo). Short- and
intermediate-term non-dietary oral and long-term dermal exposure
assessments were included for toddlers since EPA selected toxicology
endpoints for these exposures and toddlers are expected to have higher
exposures than adults from treated home environments and pets due to
their behavior patterns. Although EPA did not select a long-term non-
dietary oral endpoint for pyriproxyfen, EPA used the chronic endpoint
for the chronic (long-term) aggregate risk assessment.
Toddlers could potentially be exposed to pyriproxyfen residues on
treated carpets, floors, furniture, and pets as follows: (i). Hand-to-
Mouth: Short-, intermediate, and long-term hand-to-mouth exposures by
toddlers from treated carpets, flooring (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; efficacy of pet collars up to 395 days); (iii).
Dermal: Long-term dermal exposures from treated carpets, flooring, and
pets. (iv). Ingestion of granules or bait by toddlers (acute, episodic
event): For the granular ingestion scenario, 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 I assessment was performed based on Day 0 residues
without accounting for daily residue dissipation. EPA anticipates that
this assessment is protective as pyriproxyfen residues would be
expected to dissipate from Day 0 residue values.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether [pyriproxyfen] has a common mechanism of toxicity with other
substances. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to pyriproxyfen
and any other substances and pyriproxyfen does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that pyriproxyfen has
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common
[[Page 25834]]
mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
D. Safety Factor for Infants and Children
1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. Based on the available data,
there is no quantitative and qualitative evidence of increased
susceptibility observed following in utero pyriproxyfen exposure to
rats and rabbits or following pre/post natal exposure in the 2-
generation reproduction study.
3. Conclusion. There is a complete toxicity data base for
pyriproxyfen and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X safety factor to protect infants and children should be
reduced to 1X because there was no evidence of prenatal or postnatal
extra sensitivity or increased susceptibility in developmental studies
in rats and rabbits, and in reproduction studies in rats. Likewise,
there was no quantitative or qualitative evidence of increased
susceptibility to rat or rabbit fetuses identified in the guideline
prenatal developmental toxicity studies for rats and rabbits.
Additionally, in the 2 non-guideline studies that evaluated perinatal
and prenatal development, there was no evidence of quantitative or
qualitative increased susceptibility. In 1-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 milligrams/
kilogram/day (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 EPAs Office of Water are used to calculate DWLOCs: 2
liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). 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; therefore, acute dietary risk is not
expected.
2. Chronic aggregate risk. Using the exposure assumptions described
in this unit for chronic (long-term) exposure, EPA has concluded that
exposure to pyriproxyfen from food will utilize 1.1% of the cPAD for
the U.S. population, 2% of the cPAD for all infants, less than 1 year
old and 3.9% of the cPAD for children 1 to 2 years old, the
subpopulation at greatest exposure. Pyriproxyfen is an active
ingredient in pesticide products registered for residential use. Based
on the use patterns, the residential risk assessment was performed for
toddlers since they are anticipated to have the higher chronic
residential exposure to residues of pyriproxyfen. EPA considered
background chronic-dietary exposure (food + water), long-term,
residential non-dietary oral exposures (hand-to-mouth exposures by
toddlers following applications around the home and on pets for flea
and tick control-carpet powder and pet shampoo), and long-term dermal
exposure to toddlers. The total chronic food and residential aggregate
MOEs were calculated. As these MOEs are greater than 100, the chronic
aggregate risk does not exceed EPA's level of concern. In addition,
there is potential for chronic dietary exposure to pyriproxyfen in
drinking water. After calculating DWLOCs and comparing them to the EECs
for surface and ground water, EPA does not expect the aggregate chronic
exposure to exceed the Agency's level of concern, as shown in Table 1
of this unit:
[[Page 25835]]
Table 1.--Aggregate Risk Assessment for Chronic (Non-Cancer) 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............................... 9,200 100 0.4 0.006 12,000
All infants < 1 year.......................... 1,000 100 0.4 0.006 3,200
Children 1-2 years............................ 860 100 0.4 0.006 3,100
Children 3-5 years............................ 940 100 0.4 0.006 3,100
Females 13-49 years........................... 13,000 100 0.4 0.006 10,000
----------------------------------------------------------------------------------------------------------------
3. Short-term aggregate 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. EPA considered background chronic-dietary
exposure (food + water) and short-term, residential non-dietary oral
exposures (hand-to-mouth exposures by toddlers following applications
around the home and on pets for flea and tick control-carpet powder and
pet shampoo).
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 for toddlers ranging from 1,600 for
children 1 to 2 years old to 1,800 for children less than 1 year old.
These aggregate MOEs do not exceed the Agency's level of concern for
aggregate exposure to food and residential uses. In addition, short-
term DWLOCs were calculated and compared to the EECs for chronic
exposure of pyriproxyfen in ground water and surface water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect short-term aggregate exposure to
exceed the Agency's level of concern, as shown in Table 2 of this unit:
Table 2.--Aggregate Risk Assessment for Short-Term Exposure to Pyriproxyfen
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Sh ort-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
All infants (<1 year)......................... 1,800 100 0.4 0.006 9,400
Children 1-2 years............................ 1,600 100 0.4 0.006 9,400
Children 3-5 years............................ 1,700 100 0.4 0.006 9,400
----------------------------------------------------------------------------------------------------------------
4. Intermediate-term aggregate 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. EPA considered background
chronic-dietary exposure (food + water) and intermediate-term,
residential non-dietary oral exposures (hand-to-mouth exposures by
toddlers following applications around the home and on pets for flea
and tick control-carpet powder and pet shampoo).
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 for toddlers
ranging from 580 for children 1 to 2 years old to 650 for infants less
than 1 year 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 and ground water, EPA does not expect intermediate-term
aggregate exposure to exceed the Agency's level of concern, as shown in
Table 3 of this Unit:
Table 3.--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)
----------------------------------------------------------------------------------------------------------------
All infants < 1 year........................ 650 100 0.4 0.006 3,000
Children 1-2 years.......................... 580 100 0.4 0.006 2,900
Children 3-5 years.......................... 620 100 0.4 0.006 2,900
----------------------------------------------------------------------------------------------------------------
5. Aggregate cancer risk for U.S. population. There is no evidence
of carcinogenicity to humans based on carcinogenicity studies in male
and female rats and mice. The Agency concludes that pesticidal uses of
[[Page 25836]]
pyriproxyfen are not likely to pose a carcinogenic hazard to humans.
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
Adequate enforcement methodology (gas chromotography/nitrogen
phosphorous detector method (RM-33P-1-3a)) is available to enforce the
tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residuemethods@epa.gov.
B. International Residue Limits
There are no Codex, Canadian, or Mexican maximum residue limits
established for residues of pyriproxyfen in or on the subject food
commodities.
V. Conclusion
Therefore, the tolerance is established for residues of
pyriproxyfen, [2-[1-methyl-2-(4-phenoxyphenoxy)ethoxy]pyridine], in or
on atemoya, biriba, cherimoya, custard apple, ilama, soursop, and sugar
apple at 0.20 parts per million (ppm); avocado, black sapote, canistel,
mamey sapote, mango, papaya, sapodilla and star apple at 1.0 ppm; okra
at 0.02 ppm; fig at 0.30 ppm; and fig, dried at 1.0 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, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2003-0109 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 July 14,
2003.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by 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-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0109, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account 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).
[[Page 25837]]
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-13, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of the FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive Order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of the FFDCA. For these same reasons,
the Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 6, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
0
2. Section 180.510 is amended by alphabetically adding commodities to
the table in paragraph (a) to read as follows:
Sec. 180.510 Pyriproxyfen: tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Atemoya................................... 0.20
Avocado................................... 1.0
Biriba.................................... 0.20
Black sapote.............................. 1.0
* * * * *
Canistel.................................. 1.0
Cherimoya................................. 0.20
* * * * *
Custard apple............................. 0.20
* * * * *
Fig....................................... 0.30
Fig, dried................................ 1.0
* * * * *
Ilama..................................... 0.20
* * * * *
Mamey sapote.............................. 1.0
Mango..................................... 1.0
* * * * *
Okra...................................... 0.02
* * * * *
Papaya.................................... 1.0
* * * * *
Sapodilla................................. 1.0
* * * * *
Soursop................................... 0.20
* * * * *
Star apple................................ 1.0
* * * * *
Sugar apple............................... 0.20
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 03-12022 Filed 5-13-03; 8:45 am]
BILLING CODE 6560-50-S