Azoxystrobin; Pesticide Tolerances

[Federal Register: September 21, 2001 (Volume 66, Number 184)]
[Rules and Regulations]
[Page 48585-48593]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21se01-21]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301174; FRL-6803-1]
RIN 2070-AB78

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

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SUMMARY: This regulation establishes tolerances for combined residues
of azoxystrobin in or on acerola, atemoya, avocado, biriba, black
sapote, leafy greens (Brassica) subgroup (subgroup 5B), bushberry
subgroup (subgroup 13B), canistel, cherimoya, custard apple, eggplant,
feijoa, grass forage, grass hay, guava, ilama, jaboticaba, jackfruit,
juneberry, lingonberry, longan, loquat, lychee, mamey sapote, mango,
okra, passion fruit, pawpaw, papaya, pepper, peppermint (tops),
persimmon, pulasan, rambutan, salal, sapodilla, soursop, Spanish lime,
spearmint (tops), star apple, starfruit, strawberry, sugar apple,
tamarind, turnip (tops), watercress, wax jambu, and white sapote. The
Interregional Research Project #4 (IR-4) requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act (FQPA) of 1996. This final rule
establishes permanent tolerances for azoxystrobin, and as part of that
process the Agency has reassessed existing tolerances. By law, EPA is
required to reassess 66% of the tolerances in existence on August 2,
1996, by August 2002, or about 6,400 tolerances. All permanent
tolerances for azoxystrobin were established after August 2, 1996.
Consequently, regarding the actions in this final rule, no tolerance
reassessments are counted toward the August 2002 review deadline of
FFDCA section 408(q).

DATES: This regulation is effective September 21, 2001. Objections and
requests for hearings, identified by docket control number OPP-301174,
must be received by EPA on or before November 20, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301174 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Hoyt Jamerson, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460;
telephone number: (703) 308-9368; and e-mail address:
jamerson.hoyt@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
Examples of
Categories NAICS Codes Potentially
Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------

This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' 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.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301174. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

In the Federal Register of May 30, 2001 (66 FR 29317) (FRL-6782-2),
EPA issued a notice pursuant to section 408 of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality
Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the
filing of pesticide petitions (PP) for tolerances by IR-4, 681 U.S.
Highway #1 South, North Brunswick, NJ 08902-3390. This notice included
a summary of the petitions prepared by Zeneca Ag Products, the
registrant. There were no comments received in response to the notice
of filing.

[[Page 48586]]

The petitions requested that 40 CFR 180.507 be amended by
establishing tolerances for combined residues of the fungicide
azoxystrobin, methyl (E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate) and its Z-isomer (methyl (Z)-2-(2-(6-
(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate, in or on
food commodities as follows:
1. PP 0E6211 proposed to establish tolerances for strawberry at 10
parts per million (ppm), mint at 30 ppm, grass forage (from grass grown
for seed) at 15 ppm, grass (from grass grown for seed) hay at 20 ppm,
and watercress, tropical fruits, persimmon, paw paw, tamarind,
jackfruit, and loquat at 3.0 ppm. Since ``tropical fruits'' are not
defined for tolerance purposes by EPA, the petition was amended by IR-4
to delete tropical fruits at 3.0 ppm and to add proposed tolerances for
acerola, atemoya, avocado, biriba, black sapote, canistel, cherimoya,
custard apple, feijoa, guava, ilama, jaboticaba, longan, lychee, mamey
sapote, mango, passion fruit, papaya, pulasan, rambutan, sapodilla,
soursop, Spanish lime, star apple, starfruit, sugar apple, wax jambu
and white sapote at 2.0 ppm. In addition, the proposed tolerance levels
for persimmon, paw paw, tamarind, jackfruit and loquat were reduced to
2.0 ppm.
2. PP 1E6238 proposed to establish tolerances for bushberry
subgroup, lingonberries, juneberries, and salal at 3.0 ppm.
3. PP 1E6264 proposed to establish tolerances for the leafy
Brassica greens subgroup and turnip greens at 25 ppm, and pepper,
eggplant and okra at 2.0 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for combined residues of azoxystrobin on
acerola, atemoya, avocado, biriba, black sapote, canistel, cherimoya,
custard apple, eggplant, feijoa, guava, ilama, jaboticaba, jackfruit,
longan, loquat, lychee, mamey sapote, mango, okra, passion fruit,
pawpaw, papaya, pepper, persimmon, pulasan, rambutan, sapodilla,
soursop, Spanish lime, star apple, starfruit, sugar apple, tamarind,
wax jambu and white sapote at 2.0 ppm; bushberry subgroup, juneberry,
lingonberry, salal, and watercress at 3.0 ppm; strawberry at 10 ppm;
grass forage at 15 ppm; grass hay at 20 ppm; leafy greens (Brassica)
subgroup and turnip (tops) at 25 ppm; peppermint (tops) and spearmint
(tops) at 30 ppm. 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 nature of the toxic effects caused by azoxystrobin are
discussed in Unit III.A. of the Federal Register of September 29, 2000
(65 FR 58404).

B. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary
method currently used by the Agency to quantify carcinogenic risk. The
Q* approach assumes that any amount of exposure will lead to
some degree of cancer risk. A Q* is calculated and used to
estimate risk which represents a probability of occurrence of
additional cancer cases (e.g., risk is expressed as 1 x
10-\6\ or one in a million). Under certain specific
circumstances, MOE calculations will be used for the carcinogenic risk
assessment. In this non-linear approach, a ``point of departure'' is
identified below which carcinogenic effects are not expected. The point
of departure is typically a NOAEL based on an endpoint related to
cancer effects though it may be a different value derived from the dose
response curve. To estimate risk, a ratio of the point of departure to
exposure (MOE_cancer = point of departure/exposures) is
calculated. A summary of the toxicological endpoints for azoxystrobin
used for human risk assessment is shown in the following Table 1:

[[Page 48587]]

Table 1.--Summary of Toxicological Dose and Endpoints for Azoxystrobin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population NOAEL = <200 mg/kg/day FQPA SF = 1X Acute neurotoxicity
including infants and children) UF = 300............... aPAD = acute RfD study in rats
Acute RfD = 0.67 mg/kg/ FQPA SF. LOAEL = 200 mg/kg/day
day. = 0.67 mg/kg/day....... based on diarrhea at 2-
hours post dose at all
dose levels up to and
including 200 mg/kg/
day (the LOAEL)
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations) NOAEL= 18 mg/kg/day FQPA SF = 1X Combined chronic
UF = 100............... cPAD = chronic RfD toxicity/
Chronic RfD = 0.18 mg/ FQPA SF. carcinogenicity
kg/day. = 0.18 mg/kg/day....... feeding study in rats
LOAEL = 34/117 mg/kg/
day in males/females
based on reduced body
weights in both sexes
and bile duct lesions
in males
----------------------------------------------------------------------------------------------------------------
Short-term (1-7 days) NOAEL= 25 mg/kg/day FQPA SF = 1X Prenatal developmental
Incidental oral (residential)........ UF = 100............... oral toxicity study in
rats
LOAEL = 100 mg/kg/day
based on increased
maternal diarrhea,
urinary incontinence,
and salivation
----------------------------------------------------------------------------------------------------------------
Intermediate-term (1 week to several NOAEL= 20 mg/kg/day FQPA SF = 1X 90-Day feeding study in
months) UF = 100............... rats
Incidental oral (residential)........ LOAEL = 211/223 mg/kg/
day in males/females
based on decreased
body weight gain in
both sexes and
clinical signs
indicative of reduced
nutrition
----------------------------------------------------------------------------------------------------------------
Short-intermediate, and long-term None None 21-Day repeated dose
dermal (residential) dermal study in rats.
No dermal or systemic
toxicity was seen at
the limit dose (1,000
mg/kg/day). This risk
assessment is not
required
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 7 days) Oral study LOC for MOE = 100 Prenatal developmental
(residential) NOAEL= 25 mg/kg/day (residential) oral toxicity study in
(inhalation absorption rats
rate = 100%). LOAEL = 100 mg/kg/day
based on increased
maternal diarrhea,
urinary incontinence,
and salivation
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1 week Oral study LOC for MOE = 90-Day feeding study in
to several months) (residential) NOAEL = 20 mg/kg/day 100 (residential)...... rats
(inhalation absorption LOAEL = 211/223 mg/kg/
rate = 100%). day in males/females
based on decreased
body weight gain in
both sexes and
clinical signs
indicative of reduced
nutrition
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (>180 days) None None This risk assessment is
(residential) not applicable to the
use of azoxystrobin
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) None None Azoxystrobin is
classified ``as not
likely to be
carcinogenic in
humans''
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.507) for the combined residues of azoxystrobin,
in or on a variety of raw agricultural commodities. 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 1 day or
single exposure. The Dietary Exposure Evaluation Model
(DEEMTM) analysis evaluated the individual food consumption
as reported by respondents in the USDA 1989-1992 nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure
to the chemical for each commodity. The following assumptions were made
for the acute exposure assessments: Tolerance level residues were
assumed and it was also assumed that 100% of the crops and other
commodities with proposed or established azoxystrobin tolerances
contained those residues. Anticipated residues, and percent crop
treated (PCT) values of less than 100%, were not used.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment, the DEEMTM analysis evaluated the individual
food consumption as reported by respondents in the USDA 1989-1992
nationwide CSFII and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: Tolerance level residues were assumed and it was also
assumed that 100% of the crops and other commodities with proposed or
established azoxystrobin tolerances contained those residues.
Anticipated residues, and PCT values of less than 100%, were not used.
iii. Cancer. Since carcinogenicity studies produced no evidence
that azoxystrobin is a carcinogen, the Agency concluded that
azoxystrobin is

[[Page 48588]]

unlikely to be a human carcinogen. There is also, as a consequence, no
carcinogenicity endpoint, and this analysis was not performed.
2. Dietary exposure from drinking water. 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 may eventually build up in
environmental compartments and move into drinking water resources.
Compound 2 has greater potential to leach into ground water than the
parent as indicated in the terrestrial field studies. In these studies,
the parent azoxystrobin remained on the soil surface whereas compound 2
was detected in deeper soil profiles.
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 First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS),
to produce estimates of pesticide concentrations in an index reservoir.
The 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 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. While both
FIRST and PRZM/EXAMS incorporate an index reservoir environment, the
PRZM/EXAMS model includes a percent crop (PC) area factor as an
adjustment to account for the maximum PC coverage within a watershed or
drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to azoxystrobin, they are
further discussed in the aggregate risk sections below.
Based on the FIRST and SCI-GROW models, the estimated environmental
concentrations (EECs) of azoxystrobin for acute exposures are estimated
to be 170 parts per billion (ppb) for surface water and 0.06 ppb for
ground water. The EECs for chronic exposures are estimated to be 33 ppb
for surface water and 0.06 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).
Azoxystrobin is currently registered for use on the following
residential non-dietary sites: turf and ornamentals. The risk
assessment was conducted using the following residential exposure
assumptions:
Products containing azoxystrobin may be applied to turf 1 to 5
times per year at rates up to 0.95 lb active ingredient (a.i) per acre
(i.e., not to exceed 5 lb a.i. per acre per year) and to ornamentals at
rates up to 0.75 lb a.i. per acre every 7 to 14 days, but not to exceed
5 lb a.i./acre/year. The currently registered labels do not prohibit
homeowners from mixing/loading/applying either the flowable concentrate
or the water-dispersible granule formulations. This residential
exposure and risk assessment was conducted using the application rate
for turf because it is the highest use rate.
Residential handlers may be exposed to azoxystrobin for both short-
term dermal and inhalation exposure to azoxystrobin when mixing,
loading and applying the formulations. Adults and children may be
exposed to azoxystrobin residues from dermal contact with foliage
during post-application activities. Toddlers may receive short-term and
intermediate-term oral exposure from incidental ingestion during post-
application activities.
As no dermal endpoint was selected, a dermal exposure and risk
assessment was not conducted for residential handlers or post-
application activities. NOAELs of 25 mg/kg/day and 20 mg/kg/day were
selected for assessing the risk from short-term and intermediate-term
incidental oral exposures, respectively. These same NOAELs were
selected for assessing the risks from short-term and intermediate-term
inhalation exposures. The level of concern for risk assessment purposes
is 100.
No chemical-specific exposure or residue dissipation data for
handler or post-application activities were submitted in support of the
registered lawn uses. EPA's Draft Standard Operating Procedures (SOPs)
for Residential Exposure Assessments, and Recommended Revisions, were
used as the basis for all residential handler exposure calculations.
Some of the handler exposure data used in this assessment are from the
Outdoor Residential Exposure Task Force (ORETF). The task force
recently submitted proprietary data to the Agency on hose-end sprayers,
push-type granular spreaders, and handgun sprayers. The ORETF data were
used in this assessment in place of Pesticide Handler Exposure Data
(PHED) for the garden hose-end sprayer scenario. The ORETF data were
designed to replace the present PHED data base with higher-confidence,
higher quality data that contains more replicates than the PHED data
for those scenarios.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether azoxystrobin has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
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

[[Page 48589]]

regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62
FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

1. Safety factor for infants and children--i. In general. FFDCA
section 408 provides that EPA shall apply an additional tenfold margin
of safety for infants and children in the case of threshold effects to
account for prenatal and postnatal toxicity and the completeness of the
data base on toxicity and exposure unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a margin of exposure (MOE) analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans.
ii. Prenatal and postnatal sensitivity. Prenatal development
studies in rats and rabbits, and a 2-generation reproductive toxicity
study in rats did not indicate increased susceptibility of young rats
or rabbits to in utero and/or postnatal exposure.
iii. 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. The Agency has
determined that the 10X FQPA safety factor to protect infants and
children should be removed (that is, set to 1) because, in addition to
the completeness of the toxicological data base and the lack of
increased susceptibility of young rats and rabbits to prenatal and
postnatal exposure to azoxystrobin, the unrefined chronic dietary
exposure estimates will overestimate dietary exposure, and ground and
surface water modeling data produce upper-bound concentration
estimates.

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
azoxystrobin will occupy 11% of the aPAD for the U.S. population, 11%
of the aPAD for females 13 years and older, and 20% of the aPAD for
children 1 to 6 years, the subpopulation at greatest exposure. 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 the following Table 2:

Table 2.--Aggregate Risk Assessment for Acute Exposure to Azoxystrobin
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ %aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.67 11 170 0.06 21,000
----------------------------------------------------------------------------------------------------------------
Females (13 to 50 years) 0.67 11 170 0.06 18,000
----------------------------------------------------------------------------------------------------------------
Children (1 to 6 years) 0.67 20 170 0.06 5,400
----------------------------------------------------------------------------------------------------------------

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, 11% of the cPAD for females 13 to 50 years, and 18% of the
cPAD for children 1 to 6 years, the subpopulation at greatest exposure.
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 3:

[[Page 48590]]

Table 3.--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 0.06 5,600
----------------------------------------------------------------------------------------------------------------
Females (13 to 50 years) 0.18 11 33 0.06 4,800
----------------------------------------------------------------------------------------------------------------
Children (1 to 6 years) 0.18 18 33 0.06 1,500
----------------------------------------------------------------------------------------------------------------
Seniors 55+ years 0.18 12 33 0.06 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. A short-term risk assessment is required
for adults because there is a residential handler inhalation exposure
scenario. In addition, a short-term risk assessment is required for
infants and children because there is a residential post-application
oral exposure scenario. As no short-term or intermediate-term dermal
endpoint was established, there is no dermal component to these
aggregate risk assessments. For adults, the daily inhalation dose is
aggregated with the chronic exposure to food and water. For infants and
children, the incidental oral exposure from residential post-
application activities for infants and children was aggregated with
chronic exposure from food and water.
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 1,183 for adults and 490 for
children 1 to 6 years. 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
4:

Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Azoxystrobin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aggregate MOE
Population Subgroup (Food + Aggregate Level Surface Water EEC Ground Water EEC Short-Term DWLOC
Residential) of Concern (LOC) (ppb) (ppb) (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population 1,183 100 33 0.06 8,050
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1 to 6 years) 490 100 33 0.06 2,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). 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. An intermediate-term risk assessment is not
required for adults because residential handler scenarios are not
expected to occur for longer than a short-term timeframe. However, an
intermediate-term risk assessment is required for infants and children
because of the residential post-application oral exposure scenario. As
no dermal endpoint was established, there is no dermal component to
this aggregate risk assessment. As was necessary for the short-term
aggregate assessment, the incidental oral exposure from residential
post application activities for infants and children was aggregated
with average exposure from food and water.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in an aggregate MOE of 580 for
children 1 to 6 years. This aggregate MOE does 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 5:

Table 5.--Aggregate Risk Assessment for Intermediate-Term Exposure to Azoxystrobin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aggregate MOE
Population Subgroup (Food + Aggregate Level Surface Water EEC Ground Water EEC Intermediate-Term
Residential) of Concern (LOC) (ppb) (ppb) DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1 to 6 years old) 580 100 33 0.06 2,100
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 48591]]

5. Aggregate cancer risk for U.S. population. Azoxystrobin is
classified as ``not likely to be carcinogenic in humans'' based on the
results of carcinogenicity studies in mice and rats. Therefore,
azoxystrobin is not expected to pose a cancer risk 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 azoxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate methodology is available for enforcement of the proposed
tolerances. RAM 243, is a gas chromatography with nitrogen-phosphorus
detection (GC/NDP) method previously submitted by the registrant which
can be used for the analysis of the tolerances in or on non-oily
commodities. This method has been reviewed and validated by the Agency,
and will be submitted to the Food and Drug Administration (FDA) for
inclusion in Pesticide Analytical Manual (PAM) II. The method may be
requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.

B. International Residue Limits

No Codex, Canadian, or Mexican maximum residue levels have been
established for residues of azoxystrobin in or on these commodities.
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-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate) and its Z-isomer (methyl (Z)-2-(2-(6-
(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate, in or on
acerola at 2.0 ppm, atemoya at 2.0 ppm, avocado at 2.0 ppm, biriba at
2.0 ppm, black sapote at 2.0 ppm, bushberry subgroup at 3.0 ppm,
canistel at 2.0 ppm, cherimoya at 2.0 ppm, custard apple at 2.0 ppm,
eggplant at 2.0 ppm, feijoa at 2.0 ppm, grass forage at 15 ppm, grass
hay at 20 ppm, guava at 2.0 ppm, ilama at 2.0 ppm, jaboticaba at 2.0
ppm, jackfruit at 2.0 ppm, juneberry at 3.0 ppm, leafy greens
(Brassica) subgroup at 25 ppm, lingonberry at 3.0 ppm, longan at 2.0
ppm, loquat at 2.0 ppm, lychee at 2.0 ppm, mamey sapote at 2.0 ppm,
mango at 2.0 ppm, okra at 2.0 ppm, passion fruit at 2.0 ppm, pawpaw at
2.0 ppm, papaya at 2.0 ppm, pepper at 2.0 ppm, peppermint (tops) at 30
ppm, persimmon at 2.0 ppm, pulasan at 2.0 ppm, rambutan at 2.0 ppm,
salal at 3.0 ppm, sapodilla at 2.0 ppm, soursop at 2.0 ppm, Spanish
lime at 2.0 ppm, spearmint, tops at 30 ppm, star apple at 2.0 ppm,
starfruit at 2.0 ppm, strawberry at 10 ppm, sugar apple at 2.0 ppm,
tamarind at 2.0 ppm, turnip (tops) at 25 ppm, watercress at 3.0 ppm,
wax jambu at 2.0 ppm, white sapote at 2.0 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 of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

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

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301174 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 November
20, 2001.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-301174, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of

[[Page 48592]]

Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460. In person or by courier, bring a copy
to the location of the PIRIB described in Unit I.B.2. You may also send
an electronic copy of your request via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Regulatory Assessment Requirements

This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any other Agency action under
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note). Since tolerances and exemptions that are established on the
basis of a petition under FFDCA section 408(d), such as the tolerances
in this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VIII. Submission to Congress and the Comptroller General

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

List of Subjects in 40 CFR Part 180

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

Dated: September 10, 2001.
Peter Caulkins,
Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

1. The authority citation for part 180 continues to read as
follows:

Authority: 21 U.S.C. 321(q), 346(a) and 371.

2. Section 180.507 is amended by alphabetically adding the
following commodities to the table in paragraph (a)(1) to read as
follows:

Sec. 180.507 Azoxystrobin; tolerances for residues.

(a) * * *

[[Page 48593]]

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Acerola................................... 2.0
* * * * *
Atemoya................................... 2.0
Avocado................................... 2.0
* * * * *
Biriba.................................... 2.0
Brassica, leafy greens, subgroup.......... 25
Bushberry subgroup........................ 3.0
Canistel.................................. 2.0
* * * * *
Cherimoya................................. 2.0
* * * * *
Custard apple............................. 2.0
Eggplant.................................. 2.0
Feijoa.................................... 2.0
* * * * *
Grass, forage1............................ 15
Grass, hay1............................... 20
Guava..................................... 2.0
* * * * *
Ilama..................................... 2.0
Jaboticaba................................ 2.0
Jackfruit................................. 2.0
Juneberry................................. 3.0
Lingonberry............................... 3.0
Longan.................................... 2.0
Loquat.................................... 2.0
Lychee.................................... 2.0
Mango..................................... 2.0
Okra...................................... 2.0
Passion fruit............................. 2.0
Pawpaw.................................... 2.0
Papaya.................................... 2.0
* * * * *
Pepper.................................... 2.0
Peppermint, tops.......................... 30
Persimmon................................. 2.0
* * * * *
Pulasan................................... 2.0
Rambutan.................................. 2.0
* * * * *
Salal..................................... 3.0
Sapodilla................................. 2.0
Sapote, black............................. 2.0
Sapote, mamey............................. 2.0
Sapote, white............................. 2.0
Soursop................................... 2.0
* * * * *
Spanish lime.............................. 2.0
Spearmint, tops........................... 30
Star apple................................ 2.0
Starfruit................................. 2.0
* * * * *
Strawberry................................ 10
Sugar apple............................... 2.0
Tamarind.................................. 2.0
* * * * *
Turnip, tops.............................. 25
* * * * *
Watercress................................ 3.0
Wax jambu................................. 2.0
* * * * *
------------------------------------------------------------------------
1 There are no U.S. registrations for rangeland or pasture grass.

* * * * *

[FR Doc. 01-23607 Filed 9-20-01; 8:45 am]
BILLING CODE 6560-50-S

Notices For
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Azoxystrobin; Pesticide Tolerances

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