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Azoxystrobin - Pesticide Tolerances for Emergency Exemptions 9/00

[Federal Register: October 17, 2000 (Volume 65, Number 201)]
[Rules and Regulations]
[Page 61270-61278]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17oc00-7]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301049; FRL-6742-9]
RIN 2070-AB78
Azoxystrobin; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION:  Final rule.
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SUMMARY:  This regulation establishes a time-limited tolerance for
residues of azoxystrobin or methyl (E)-2-2-[6-(2-
cyanophenoxy)pyrimidin-4-yloxy]phenyl-3-methoxyacrylate) and its Z
isomer in or on brassica leafy vegetable. This action is in response to
EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing
use of the pesticide on brassica leafy vegetable. This regulation
establishes a maximum permissible level for residues of azoxystrobin in
this food commodity. The tolerance will expire and is revoked on
December 31, 2001.

DATES:  This regulation is effective October 17, 2000. Objections and
requests for hearings, identified by docket control number OPP-301049,
must be received by EPA on or before December 18, 2000.

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 VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301049 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:  By mail: Jacqueline E. Gwaltney,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: 703 305-6792; and e-mail
address: gwaltney.jackie@epa.gov.

SUPPLEMENTARY INFORMATION:

[[Page 61271]]

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected 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." You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-301049. 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, 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

    EPA, on its own initiative, in accordance with sections 408 (l)(6)
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is
establishing a tolerance for residues of the fungicide azoxystrobin or
methyl (E)-2-2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl-3-
methoxyacrylate) and its Z isomer, in or on brassica leafy vegetable at
25.0 parts per million (ppm). This tolerance will expire and is revoked
on December 31, 2001. EPA will publish a document in the Federal
Register to remove the revoked tolerances from the Code of Federal
Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
    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. . . ."
    Section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from
any provision of FIFRA, if EPA determines that "emergency conditions
exist which require such exemption." This provision was not amended by
the Food Quality Protection Act (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Azoxystrobin on Brassica Leafy
Vegetable and FFDCA Tolerances

    Georgia has also requested the use of azoxystrobin to control leaf
spots of leafy greens caused by Cercospora brassicicola and
cercosporella brassica. Losses due to these fungal pathogens have
increased in recent year and, in some cases, entire fields are
destroyed because leaves of greens are unmarketable due to spotting.
    EPA has authorized under FIFRA section 18 the use of azoxystrobin
on brassica leafy vegetable. After having reviewed the submission, EPA
concurs that emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of azoxystrobin in or on
brassica leafy vegetable. In doing so, EPA considered the safety
standard in FFDCA section 408(b)(2), and EPA decided that the necessary
tolerance under FFDCA section 408(l)(6) would be consistent with the
safety standard and with FIFRA section 18. Consistent with the need to
move quickly on the emergency exemption in order to address an urgent
non-routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing this tolerance without notice and opportunity
for public comment as provided in section 408(l)(6). Although these
tolerances will expire and are revoked on December 31, 2001, under
FFDCA section 408(l)(5), residues of the pesticide not in excess of the
amounts specified in the tolerance remaining in or on brassica leafy
vegetable after that date will not be unlawful, provided the pesticide
is applied in a manner that was lawful under FIFRA, and the residues do
not exceed a level that was authorized by this tolerance at the time of
that application. EPA will take action to revoke this tolerance earlier
if any experience with, scientific data on, or other relevant
information on this

[[Page 61272]]

pesticide indicate that the residues are not safe.
    Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether azoxystrobin
meets EPA's registration requirements for use on brassica leafy
vegetable or whether a permanent tolerance for this use would be
appropriate. Under these circumstances, EPA does not believe that this
tolerance serves as a basis for registration of azoxystrobin by a State
for special local needs under FIFRA section 24(c). Nor does this
tolerance serve as the basis for any State other than to use this
pesticide on this crop under section 18 of FIFRA without following all
provisions of EPA's regulations implementing section 18 as identified
in 40 CFR part 166. For additional information regarding the emergency
exemption for azoxystrobin, contact the Agency's Registration Division
at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    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) .
    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
azoxystrobin and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerances for
residues of azoxystrobin in or on brassica leafy vegetable at 25.0 ppm.
EPA's assessment of the dietary exposures and risks associated with
establishing the tolerance follows.

A. 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 endpoint. 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 intra species differences. Discuss any additional uncertainty
factors (other than the FQPA SF) used in the assessment.
    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 level of concern (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 shown in
the following Table 1:

Table 1.--Summary of Toxicological Doses and Endpoints for Azoxystrobin for Use in Human Risk Assessment
--------------------------------------------------------------------------------------------------------
                                                         TES/RfD/FQPA Committee
               Endpoint            Dose (mg/kg/day)          Determinations             Conclusion
--------------------------------------------------------------------------------------------------------
Acute Dietary                                           No appropriate endpoint  This risk assessment is
                                                         was identified for       not required.
                                                         this exposure
                                                         scenario. No
                                                         developmental toxicity
                                                         was observed in the
                                                         rabbit and rat studies
                                                         reviewed. Effects seen
                                                         in the acute
                                                         neurotoxicity study
                                                         were due to abdominal
                                                         discomfort, not
                                                         primary neurotoxicity
                                                         (TES Committee, 12/10/
                                                         96).
--------------------------------------------------------------------------------------------------------

Chronic Dietary                NOAEL = 18.2 UF = 100    The RfD was established  This risk assessment is
                                                         based on a chronic       required. Chronic RfD
                                                         toxicity study           =0.18 mg/kg/day.
                                                         (MRID43678139
                                                         ) in rats with a NOAEL
                                                         of 18.2 mg/kg/day.
                                                         Reduced body weights
                                                         and bile duct lesions
                                                         were observed at the
                                                         LOAEL of 34 mg/kg/day.
                                                         An uncertainty factor
                                                         of 100 was used to
                                                         account for both the
                                                         inter-species
                                                         extrapolation and the
                                                         intra-species
                                                         variability (see Memo,
                                                         RfD Committee, 11/7/
                                                         96).
--------------------------------------------------------------------------------------------------------

[[Page 61273]]

FQPA Safety Factor                                      The FQPA Safety Factor   10x Safety Factor was
                                                         Committee recommended    removed. The chronic
                                                         that the10x Safety       population adjusted
                                                         Factor be removed for    dose is equivalent to
                                                         the following reasons:   the chronic RfD (cPAD
                                                         1) the toxicology data   = cRfD).
                                                         base is complete; 2)
                                                         the developmental and
                                                         reproductive toxicity
                                                         data did not indicate
                                                         increased
                                                         susceptibility of rats
                                                         or rabbits to in utero
                                                         and/or postnatal
                                                         exposure; 3) unrefined
                                                         chronic dietary
                                                         exposure estimates
                                                         (assuming all
                                                         commodities contain
                                                         tolerance level
                                                         residues) will
                                                         overestimate dietary
                                                         exposure; 4) modeling
                                                         data are used for
                                                         ground and surface
                                                         source drinking water
                                                         exposure assessments
                                                         resulting in estimates
                                                         considered to be upper-
                                                         bound concentrations;
                                                         and 5) there are
                                                         currently no
                                                         registered residential
                                                         uses for Azoxystrobin
                                                         (FQPA document, 9/3/
                                                         98).
--------------------------------------------------------------------------------------------------------

Carcinogenicity                                         The HED RfD/Peer Review  A cancer risk assess-
                                                         Committee determined     ment is not required.
                                                         that azoxystrobin
                                                         should be classified
                                                         as "Not Likely" to
                                                         be a human carcinogen
                                                         according to the
                                                         proposed revised
                                                         Cancer Guidelines (See
                                                         TES Document, 12/10/
                                                         96).
--------------------------------------------------------------------------------------------------------

B. Residue Information

    Tolerances for azoxystrobin (including time-limited tolerances) are
published in 40 CFR 180.507. The tree nuts tolerance of 0.01 ppm which
is listed in the 40 CFR was amended to 0.02 ppm.
     For this analysis, tolerance level residues and 100 percent crop
treated assumptions were made for all commodities. Processing studies
show that residues do not concentrate in the following foods: citrus
juice, grapes-raisins, plums-prunes (dried), potatoes-white (dry),
grape juice, tomato juice, and tomatoes-puree. As a result, DEEM
default processing factors (adjustment factors #1) were set to 1.0 for
these commodities. The concentration factors for the following juice
concentrates were changed to preserve the concentration ratio from
juice to concentrate: grapes (3.6 to 3.0), grapefruit (8.3 to 3.9),
lemons (11.4 to 5.7), limes (6 to 3), oranges (6.7 to 3.7), and
tangerines (7.4 to 3.2).* 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 residues of azoxystrobin, in or on
a variety of raw agricultural commodities at levels ranging from 0.010
ppm in tree nuts to 20 ppm in rice hulls. Included in these tolerances
are numerous ones for animal commodities which were established in
conjunction with tolerances for rice and wheat commodities. Risk
assessments were conducted by EPA to assess dietary exposures from
azoxystrobin in food as follows:
     i. Acute risk. No toxicological effects which could be attributed
to a single dietary exposure were observed, including developmental and
neurotoxic effects in the appropriate studies. The Dietary Exposure
Evaluation Model (DEEM) analysis evaluated the individual food
consumption as reported by respondents in the USDA 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:
    ii. Chronic risk. (Chronic RfD = 0.18 mg/kg/day) In conducting this
chronic dietary risk assessment, HED has made very conservative
assumptions: 100% of Brassica vegetables and turnip tops and all other
commodities having azoxystrobin tolerances will contain azoxystrobin
residues, and those residues will be at the level of the tolerance.
Default concentration factors have been removed (i.e., set to 1) for
the following commodities: grapes-juice, grapes-raisins, tomatoes-
juice, tomatoes-puree, and potatoes-white (dry). Concentration factors
were removed because data which were previously submitted show no
concentration of residues into raisins, tomato juice and puree or
potatoes. The default ratio between grape juice and juice concentrate
was retained.
     The Novigen DEEM (Dietary Exposure Evaluation Model) system was
used for this chronic dietary exposure analysis. The analysis evaluates
individual food consumption as reported by respondents in the USDA
Continuing Surveys of Food Intake by Individuals conducted in 1989
through 1991. The model accumulates exposure to the chemical for each
commodity and expresses risk as a function of dietary exposure.
     The existing azoxystrobin tolerances (published, pending, and
including the necessary Section 18 tolerance(s)) result in a
theoretical maximum residue contribution (TMRC) that is equivalent to
the following percentages of the Chronic RfD. As the 10x safety factor
was removed, the chronic RfD is equal to the PAD (population-adjusted
dose). As a result, the exposure given as a percentage of the total
allowable exposure is reported as %PAD, as shown in the following Table
2:

[[Page 61274]]

    Table 2.--Summary: Chronic Exposure Analysis by the DEEM Systems
------------------------------------------------------------------------
                                                 Percent Reference
 Population Subgroup         Exposure (mg/kg/    Dose 1 (%Chronic
                                   day)              PAD/RfD)
------------------------------------------------------------------------
U.S. Population (total)           0.012207             7.4%
------------------------------------------------------------------------

All Infants (less than 1 year     0.014855            11.5%
 old)
------------------------------------------------------------------------

Nursing Infants (less than 1      0.003915             3.1%
 year old)
------------------------------------------------------------------------

Non-Nursing Infants (less than 1  0.019460            14.0%
 year old)
------------------------------------------------------------------------

Children (1-6 years old)          0.021949            12.1%
------------------------------------------------------------------------

Children (7-12 years old)         0.012950             7.7%
------------------------------------------------------------------------

Non-Hispanic Blacks               0.016431             9.1%
------------------------------------------------------------------------

Non-Hispanic/non- white/non-      0.020967            14.8%
 black
------------------------------------------------------------------------

Females (13+/nursing)             0.014210             8.8%
------------------------------------------------------------------------

Seniors 55+                       0.013462             7.5%
------------------------------------------------------------------------
1 Percentage reference dose (% Chronic PAD) = Exposure/Chronic PAD x
  100% (as RfD=PAD in this case)

     The subgroups listed above are: (1) the U.S. Population (total);
(2) those for infants and children; and, (3) the other subgroups
(except regions and seasons) for which the percentage of the Chronic
PAD occupied is greater than that occupied by the subgroup U.S.
Population (total).
    iii. Anticipated residue and percent crop treated information. The
Agency used percent crop treated (PCT) information as follows:
    A routine chronic dietary exposure analysis for the wheat
hybridizing agent X was based on 0.1% of wheat crop treated, and 0.1%
of the cereal grains group (except rice, wild rice, sweet corn, and
wheat) and soybeans as rotated crops in fields previously containing
wheat treated with chemical X. PCT of 0.1% was based on the
petitioner's expectations that up to 35,000 acres of wheat grown for
seed will be treated annually, which amounts to 0.05% of the 70,000,000
acres of wheat grown in the United States. The reason for using 0.1%
instead of 0.05% is to allow expansion of use if other conditions of
registration are satisfied. Before expansion beyond 0.1% is allowed,
reevaluation of the dietary exposure may be performed using all
available information.
    The Agency believes that the three conditions previously discussed
have been met. With respect to Condition 1, EPA finds that the PCT
information described above for chemical X used on wheat grown for seed
is reliable and has a valid basis. Chemical X is a hybridizing agent
specific for sterilizing the male organ of the wheat plant in seed
production. The majority of seed will be used planting purposes, and
not directly as food or feed. Before the petitioner can increase
production of product for treatment of greater than 35,000 acres per
year, permission from the Agency must be obtained. As to Conditions 2
and 3, regional consumption information and consumption information for
significant subpopulations is taken into account through EPA's
computer-based model for evaluating the exposure of significant
subpopulations including several regional groups. Use of this
consumption information in EPA's risk assessment process ensures that
EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which pesticide X
may be applied in a particular area.
    2. Dietary exposure from drinking water. Azoxystrobin is persistent
and mobile. There is no established Maximum Contaminant Level for
residues of azoxystrobin in drinking water. No health advisory levels
for azoxystrobin in drinking water have been established (EPA Safe
Drinking Water Hotline, 1 (800) 426-4791, 4/15/99). EFED has supplied
RAB2 with estimates for the concentration of azoxystrobin in surface
water based on GENEEC (Generic Estimated Environmental Concentration)
modeling and in ground water based on SCI-GROW modeling.
     Chronic risk. Estimated environmental concentrations (EECs) using
GENEEC for azoxystrobin on bananas, grapes, peaches, peanuts, pecans,
tomatoes, and wheat are listed in the SWAT Team Second Interim Report
(6/20/97).
     The highest EEC for azoxystrobin in surface water (39 g/
L) is from the application of azoxystrobin to grapes. The EEC for
ground water is 0.064 g/L resulting from use on turf. For
purposes of risk assessment, the maximum EEC for azoxystrobin in
drinking water (39 g/L) should be used for comparison to the
back-calculated human health drinking water levels of comparison
(DWLOC) for the chronic (non-cancer) endpoint. These DWLOCs for various
population categories are summarized in the following Table 3:

                       Table 3.--Drinking Water Levels of Comparison for Chronic Exposure1
-----------------------------------------------------------------------------------------------------
                                                     Chronic       Food      Max. Water   DWLOC 4,5,6
                    Population Category2          RfD  (mg/kg/   Exposure    Exposure3   (μg/L)
                                                      day)     (mg/kg/day)  (mg/kg/day)
-----------------------------------------------------------------------------------------------------
U.S. Population (total)                                  0.18    0.0122 07        0.168         5,900
-----------------------------------------------------------------------------------------------------
Females (13+ years, nursing)                             0.18    0.0142 10        0.166         5,000
-----------------------------------------------------------------------------------------------------
Non-nursing Infants (less than 1 year old)               0.18    0.0194 60        0.161        1,600
-----------------------------------------------------------------------------------------------------
1 Values are expressed to 2 significant figures.
2 Within each of these categories, the subgroup with the highest food exposure was selected.
3 Maximum Water Exposure (Chronic) (mg/kg/day) = Chronic RfD (mg/kg/day) - Food Exposure (mg/kg/day).
4 DWLOC(μg/L) = Max. water exposure (mg/kg/day) x body wt (kg)  (10-3 mg/g) * water
  consumed daily (L/day).
5 Default body weights are: General U.S. Population, 70 kg; Males (13+ years old), 70 kg; Females (13+ years
  old), 60 kg; Other Adult Populations, 70 kg; and, All Infants/Children, 10 kg.
6 Default daily drinking rates are 2 L/day for adults and 1 L/day for children.

[[Page 61275]]

     The estimated maximum concentrations of azoxystrobin in surface
water and ground water are less than EPA's levels of comparison for
azoxystrobin in drinking water as a contribution to chronic aggregate
exposure. Therefore, taking into account the present uses and uses
proposed in this Section 18 and the fact that GENEEC can substantially
overestimate (by up to 3x) true pesticide concentrations in drinking
water, EPA concludes with reasonable certainty that residues of
azoxystrobin in drinking water (when considered along with other
sources of chronic exposure for which EPA has reliable data) would not
result in an unacceptable estimate of chronic (non-cancer) aggregate
human health risk at this time.
     EPA bases this determination on a comparison of estimated average
concentrations of azoxystrobin in surface and ground water to back-
calculated DWLOCs for azoxystrobin in drinking water. These levels of
comparison in drinking water were determined after HED considered all
other non-occupational human exposures for which it has reliable data,
including all current uses, and the use considered in this action. The
estimate of azoxystrobin in surface water is derived from a water
quality model that uses conservative assumptions (health-protective)
regarding the pesticide transport from the point of application to
surface and ground water. 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 azoxystrobin in drinking water as a part of the
chronic (non-cancer) aggregate risk assessment process.
    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 Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in groundwater. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
    None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to azoxystrobin they are
further discussed in the aggregate risk sections below.
    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: ornamental turf. The risk assessment was
conducted using the following exposure assumptions: Short-term exposure
may occur for residential handlers and for postapplication activities.
Because the TES Committee (11/12/96) did not select applicable acute
dietary or short-term dermal or inhalation endpoints, a short-term risk
assessment is not required. No toxicity was observed at the limit dose
(1,000 mg/kg body wt/day) in a 21-day dermal study and an acute
inhalation study indicated low toxicity. Intermediate-term and chronic
exposures are not expected for residential use.
    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 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

    Safety factor for infants and children--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.

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.

[[Page 61276]]

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+ chronic non-dietary,
non-occupational 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 groundwater are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to azoxystrobin 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
azoxystrobin on drinking water as a part of the aggregate risk
assessment process.
     1. Chronic risk. Using the conservative TMRC exposure assumptions
described in this unit for chronic exposure, EPA has concluded that
exposure to azoxystrobin from food will utilize 11.6% of the cPAD for
the U.S. population, 2.2% of the cPAD for infant subpopulations at
greatest exposure and 12.2% of the cPAD for children subpopulation at
greatest exposure. Based the use pattern, chronic residential exposure
to residues of the azoxystrobin is not expected. In addition, despite
the potential for chronic dietary exposure to azoxystrobin in drinking
water, after calculating the DWLOCs and comparing them to conservative
model estimated environmental concentrations of azoxystrobin in surface
and ground water. EPA does not expect the aggregate exposure to exceed
100% of the cPAD.
    2. Short-term risk. There are no applicable endpoints for short-
term exposure; therefore, a short-term aggregate risk assessment is not
required. Intermediate-term exposure is not expected for registered
residential uses; therefore, an intermediate-term risk assessment is
not required.
    Short-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
    Though residential exposure could occur with the use of
azoxystrobin, the potential short-term exposures were not aggregated
with chronic dietary food and water exposures because the toxic effects
are different. Therefore, based on the best available data and current
policies, potential risks do not exceed the Agency's level of concern.
    3. Aggregate cancer risk for U.S. population. The EPA RfD/Peer
Review Committee (November 7, 1996) determined that azoxystrobin should
be classified as "Not Likely" to be a human carcinogen according to
the proposed revised Cancer Guidelines. Therefore, a cancer risk
assessment is not required.
    4. 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.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical method is available for enforcement of the
proposed tolerances. Method RAM 243 (GC/NPD) can be used for the
commodities in crop groups 2 and 5. The limit of quantitation for
spinach and leaf lettuce was 0.01 ppm and the LOQ for head lettuce was
either 0.02 ppm or 0.05 ppm (depending on laboratory). This method has
been validated by the Agency's Analytical Chemistry Laboratory and will
be submitted to FDA for inclusion in 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

    There are no CODEX, Canadian, or Mexican Maximum Residue Limits
(MRL) for azoxystrobin.

C. Conditions

    No special conditions, other than this tolerance are in conjunction
with a Section 18 specific exemption.

VI. Conclusion

    Therefore, the tolerance is established for residues of
azoxystrobin in or on brassica leafy vegetable at 25.0 ppm ppm.

VII. 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-301049 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 December
18, 2000.
    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

[[Page 61277]]

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 VII.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 the docket control number OPP-301049, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 file format 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).

VIII. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA
section 408. 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).
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 prior consultation
as specified by Executive Order 13084, entitled Consultation and
Coordination with Indian Tribal Governments (63 FR 27655, May 19,
1998); special considerations as required by Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or require 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 FIFRA
section 18 petition under FFDCA section 408, such as the tolerance/
exemption 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).

IX. 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

[[Page 61278]]

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 28, 2000.

James Jones,

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), (346a) and 371.

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

Sec. 180.507   Azoxystrobin; tolerances for residues.

* * * * *
    (b)* * *

----------------------------------------------------------------------------------------
Commodity                             Parts per million   Expiration/Revocation Date
----------------------------------------------------------------------------------------
       *        *        *        *        *
Brassica leafy vegetable............        25.0                      12/31/01
       *        *        *        *        *
----------------------------------------------------------------------------------------

* * * * *

[FR Doc. 00-26638 Filed 10-16-00; 8:45 am]
BILLING CODE 6560-50-S