[Federal Register Volume 68, Number 117 (Wednesday, June 18, 2003)]
[Rules and Regulations]
[Pages 36480-36487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15261]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0196; FRL-7311-2]
Azoxystrobin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of azoxystrobin, methyl (E)-2-[[6-(2-cyanophenoxy)-4-pyrimidinyl]oxy]-
[v]-(methoxymethylene)-benzeneacetate,
and its Z isomer, methyl (Z)-2-[[6-(2-cyanophenoxy)-4-pyrimidinyl]oxy]-
[v](methoxymethylene)-benzeneacetate, in
or on artichoke, globe; asparagus; brassica, head and stem, subgroup
5A; herb subgroup 19A, (dried) except chive; and herb subgroup 19A,
(fresh) except chive. 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).
[[Page 36481]]
DATES: This regulation is effective June 18, 2003. Objections and
requests for hearings, identified by docket identification (ID) number
OPP-2003-0196, must be received on or before August 18, 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: Shaja R. Brothers, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, and 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 ID number OPP-2003-0196. 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 26, 2003 (68 FR 14622) (FRL-7299-
3), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, as amended by FQPA (Public Law 104-170), announcing the filing of
pesticide petitions (PP 2E6375, 2E6488, 2E6489, and 2E6495) by IR-4,
681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390. That
notice included a summary of the petitions prepared by Syngenta, the
registrant.
The petitions requested that 40 CFR 180.507 be amended by
establishing tolerances for combined residues of the fungicide
azoxystrobin, methyl (E)-2-[[6-(2-cyanophenoxy)-4-pyrimidinyl]oxy]-
[v]-(methoxymethylene) benzeneacetate and
its Z isomer methyl (Z)-2-[[6-(2-cyanophenoxy)-4-pyrimidinyl]oxy]-
[v]-(methoxymethylene) benzeneacetate, in
or on artichoke, globe at 4.0 parts per million (ppm); asparagus at
0.02 ppm; brassica, head and stem, subgroup 5A at 3.0 ppm; herb
subgroup 19A, dried, except chive at 260 ppm; and herb subgroup 19A,
fresh, except chive at 50 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) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of the FFDCA, for tolerances for combined residues of
azoxystrobin on artichoke, globe at 4.0 ppm; asparagus at 0.04 ppm;
brassica, head and stem, subgroup 5A at 3.0 ppm; herb subgroup 19A,
dried, except chive at 260 ppm; and herb subgroup 19A, fresh, except
chive at 50 ppm. EPA's assessment of exposures and risks associated
with establishing the 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
[[Page 36482]]
infants and children. The nature of the toxic effects caused by
azoxystrobin are discussed in Unit III.A of the Final Rule on
Azoxystrobin Pesticide Tolerance published in the Federal Register on
September 20, 2002 (67 FR 59169)(FRL-7198-9).
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
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 azoxystrobin used for human risk assessment is discussed
in Unit III.B. of the Final Rule on Azoxystrobin Pesticide Tolerance
published in the Federal Register on September 20, 2002 (67 FR
59169)(FRL-7198-9).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.507) for the combined residues of azoxystrobin,
in or on a variety of raw agricultural commodities. Tolerances have
been established for residues of azoxystrobin in or on a variety of raw
agricultural commodities at levels ranging from 0.01 ppm (pecans) to 55
ppm (soybean hay), and on meat, fat, and meat byproducts of cattle,
goats, hogs, horses, and sheep at levels ranging from 0.01 to 0.07 ppm,
and on milk at 0.006 ppm. A time-limited tolerance (to expire on 12/31/
2003) is currently established at 30 ppm for the head and stem Brassica
vegetables, subgroup 5A. Risk assessments were conducted by EPA to
assess dietary exposures from azoxystrobin 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. In conducting this acute risk assessment, EPA used
the Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCIDTM) 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 assumption was made for the acute exposure assessment: A
Tier 1 acute dietary exposure analysis was performed for azoxystrobin.
ii. Chronic exposure. In conducting this chronic risk assessment,
EPA used the Dietary Exposure Evaluation Model software with the Food
Commodity Intake Database (DEEM-FCIDTM) 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 analysis was performed for
the general U.S. Population and all population subgroups using
tolerance level residues (livestock) and total residues of concern
(plants; parent and metabolites) and 100% crop treated data for the
proposed commodities and all registered uses.
iii. Cancer. EPA's Cancer Assessment Review Committee (CARC)
evaluated the carcinogenic potential of azoxystrobin and classified
azoxystrobin as ``not likely to be a human carcinogen'' based on the
revised Cancer Guidelines.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for azoxystrobin 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 azoxystrobin.
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 pesticide concentrations in an index
reservoir. The screening concentration in groundwater (SCI-GROW) model
is used to predict pesticide concentrations in shallow groundwater. For
a screening-level assessment for surface water EPA will use FIRST (a
tier 1 model) before using PRZM/EXAMS (a tier 2 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.
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.
[[Page 36483]]
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead, drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to azoxystrobin they are
further discussed in the aggregate risk section in Unit III.E.
Although moderately persistent in soils and stable to hydrolysis,
the likelihood of azoxystrobin moving into ground and surface water is
low due to high soil/water partitioning coefficients and low single
application rates. However, with multiple applications and repeated
usage, azoxystrobin and especially its degradate (``compound 2'', (E)-
2-2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]-3-methoxyacrylic acid) may
eventually build up in environmental compartments and move into
drinking water resources.
Based on the Tier I modeling results using the FQPA Index Reservoir
Screening Tool (FIRST) model, azoxystrobin EECs in surface water are
not likely to exceed 170 parts per billion (ppb) for the acute (peak)
concentration or 33 ppb for the chronic (365-day) concentration. These
values represent upper-bound estimates of the concentrations that might
be found in surface water which result from the use of azoxystrobin on
turf.
The SCI-GROW screening model developed in the Agency estimates
potential ground water concentrations under hydrologically vulnerable
conditions. Based on the highest use rate (turf use, nine applications
per year, 10-day interval, and 0.55 lb ai/A/application), the upper-
bound concentration of azoxystrobin was estimated at 3.1 ppb. This
value was used for both acute and chronic risk assessments. This value
represents upper-bound estimates of the concentrations that might be
found in ground water which result from the use of azoxystrobin on
turf.
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).
Azoxystrobin is currently registered for use on residential non-
dietary sites (turf and ornamentals). The risk assessment was conducted
using the following residential exposure assumptions: There is a
potential for short-term dermal and inhalation exposures to homeowners
who apply products containing azoxystrobin; however, EPA did not
identify dermal endpoints for azoxystrobin. Because no dermal endpoints
could be indentified, EPA expects no risk from dermal exposure to
azoxystrobin. There is also potential for non-dietary, oral exposure
following lawn treatment. Short- and intermediate-term non-dietary,
oral exposure assessments were included for toddlers, since EPA
selected toxicology endpoints for these exposures and there is a
potential for hand-to-mouth and object-to mouth transfer of residues
from treated turfgrass and incidential ingestion of soil from treated
turfgrass.
Postapplication exposures from various activities following lawn
treatment are considered to be the most common and significant in
residential settings. The exposure via incidental ingestion of other
plant material may occur but is considered negligible. The residential
exposure and risk assessment was conducted using the application for
turf because it is the highest single use rate. Azoxystrobin may be
applied to turf at rates of up to 0.9516 active ingredient (a.i.) per
acre five times per year (i.e., not to exceed 5 lb/ai/acre/year).
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 azoxystrobin 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 azoxystrobin
and any other substances and azoxystrobin 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 azoxystrobin 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 mechanism on EPA's Web site 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. Azoxystrobin studies have
indicated no increased susceptibility of rats or rabbits to in utero
and/or postnatal exposure to azoxystrobin.
3. Conclusion. There is a complete toxicity data base for
azoxystrobin and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10-fold safety factor for increased susceptibility of infants
and children be removed (i.e., reduced to 1X). The FQPA factor is
removed because:
[sbull] The toxicology data base is complete
[sbull] The developmental and reproductive toxicity data did not
indicate increased susceptibility of rats or rabbits to in utero and/or
postnatal exposure
[sbull] Unrefined chronic dietary exposure estimates (assuming all
commodities contain tolerance level residues) will overestimate dietary
exposure
[sbull] Modeling data are used for ground and surface source
drinking water exposure assessments resulting in estimates considered
to be upper-bound concentrations
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
[[Page 36484]]
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: 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 groundwater 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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
azoxystrobin will occupy 10% of the aPAD for the U.S. population, 17%
of the aPAD for children 1-2 years old, 9% of the aPAD for females 13
years and older, and 10% of the aPAD for adults 50+ years old. In
addition, there is potential for acute dietary exposure to azoxystrobin
in drinking water. After calculating DWLOCs and comparing them to the
EECs for surface and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the aPAD, as shown in Table 1 of this unit:
Table 1.--Aggregate Risk Assessment for Acute Exposure to azoxystrobin
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Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population................................ 0.67 10 170 3.1 21,000
Children 1-2 years old......................... 0.67 17 170 3.1 5,600
Females 13-49 years............................ 0.67 9 170 3.1 18,000
Adults (50+ years)............................. 0.67 10 170 3.1 21,000
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
azoxystrobin from food will utilize 12% of the cPAD for the U.S.
population, 22% of the cPAD for children 1-2 years old, 11% of the cPAD
for females 13-49 years old, and 11% for adults 50+ years old. Based on
the use pattern, chronic residential exposure to residues of
azoxystrobin is not expected. In addition, there is potential for
chronic dietary exposure to azoxystrobin in drinking water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in the following Table 2:
Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Azoxystrobin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population................................ 0.18 12 33 3.1 5,500
Children 1-2 years............................. 0.18 22 33 3.1 1,400
Females 13-49 years............................ 0.18 11 33 3.1 4,800
Adults 50+ years............................... 0.18 11 33 3.1 5,600
----------------------------------------------------------------------------------------------------------------
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).
Azoxystrobin 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 azoxystrobin.
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 1,200 for adults, and 430 for
children 1-2 years old. These aggregate MOEs do not exceed the Agency's
level of concern for aggregate exposure to food and residential uses.
In addition, short-term DWLOCs were calculated and compared to the EECs
for chronic exposure of azoxystrobin in ground and surface water. After
calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect short-term aggregate exposure to
exceed the Agency's level of concern, as shown in the following Table
3:
[[Page 36485]]
Table 3.--Aggregate Risk Assessment for Short-Term Exposure to Azoxystrobin
----------------------------------------------------------------------------------------------------------------
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............................... 1,200 100 33 3.1 8,000
Children 1-2 years old........................ 430 100 33 3.1 1,900
----------------------------------------------------------------------------------------------------------------
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).
Azoxystrobin 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 azoxystrobin.
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 420 for
children 1-2 years old. These aggregate MOEs do not exceed the Agency's
level of concern for aggregate exposure to food and residential uses.
In addition, intermediate-term DWLOCs were calculated and compared to
the EECs for chronic exposure of azoxystrobin in ground and surface
water. After calculating DWLOCs and comparing them to the EECs for
surface and ground water, EPA does not expect intermediate-term
aggregate exposure to exceed the Agency's level of concern, as shown in
the following Table 4:
Table 4.--Aggregate Risk Assessment for Intermediate-Term Exposure to Azoxystrobin
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Intermediate-
Population Subgroup MOE (Food + Concern Water EEC Water EEC Term DWLOC
Residential) (LOC) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old...................... 420 100 33 3.1 1,600
----------------------------------------------------------------------------------------------------------------
5. Aggregate cancer risk for U.S. population. There is no evidence
for mutagenicity or carcinogenicity. Azoxystrobin has been classified
as ``not likely to be carcinogenic in humans'' by EPA; therefore,
azoxystrobin is not expected to pose a carcinogenic risk.
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 azoxystrobin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate methodology is available for enforcement of these
tolerances. The gas chromatography/nitrogen phosphorous detector (GC/
NPD) method (RAM 243/04) has undergone a method validation by the EPA
analytical laboratory. EPA comments have been incorporated and the
revised method (designated RAM 243) will be submitted to FDA for
inclusion in PAM, Volume II as an enforcement method.
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:
[email protected].
B. International Residue Limits
No Codex, Canadian, or Mexican Maximum Residue Levels (MRLs) have
been established for residues of azoxystrobin. Therefore, no tolerance
discrepancies exist between countries for this chemical.
V. Conclusion
Therefore, the tolerances are established for combined residues of
azoxystrobin, methyl (E)-2-[[6-(2-cyanophenoxy)-4-pyrimidinyl]oxy]-
[v]-(methoxymethylene)-benzeneacetate,
and its Z isomer, methyl (Z)-2-[[6-(2-cyanophenoxy)-4-pyrimidinyl]oxy]-
[v]-(methoxymethylene)-benzeneacetate, in
or on artichoke, globe at 4.0 ppm; asparagus at 0.04 ppm; brassica,
head and stem, subgroup 5A at 3.0 ppm; herb subgroup 19A, dried, except
chive at 260 ppm; and herb subgroup 19A, fresh, except chive at 50 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-2003-0196 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before August
18, 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
[[Page 36486]]
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 [email protected],
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
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-2003-0196, 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: [email protected]. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of the FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this rule does not have any ``tribal implications''
as described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop
[[Page 36487]]
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: June 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 180.507 is amended by adding alphabetically commodities to
the table in paragraph (a)(1) to read as follows:
Sec. 180.507 Azoxystrobin; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Artichoke, globe........................................ 4.0
Asparagus............................................... 0.04
* * * * *
Brassica, head and stem, subgroup 5A.................... 3.0
* * * * *
Herb subgroup 19A, dried, except chive.................. 260
Herb subgroup 19A, fresh, except chive.................. 50
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 03-15261 Filed 6-17-03; 8:45 am]
BILLING CODE 6560-50-S