[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]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0196; FRL-7311-2]


Azoxystrobin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                                             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