[Federal Register Volume 67, Number 183 (Friday, September 20, 2002)]
[Rules and Regulations]
[Pages 59169-59177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23808]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0238; FRL-7198-9]


Azoxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for combined residues 
of azoxystrobin and its z-isomer in or on caneberry subgroup at 5.0 
part per million (ppm); cranberry at 0.50 ppm; hop, dried cones at 20.0 
ppm; pistachio at 0.50 ppm; vegetable, legume, edible podded, subgroup, 
except soybean at 3.0 ppm; pea and bean, succulent shelled, subgroup, 
except cowpea at 0.50 ppm; and pea and bean, dried shelled, except 
soybean subgroup, except cowpea and field pea at 0.50. The 
Interregional Research Project 4 (IR-4) and Syngenta Crop 
Protection, Inc. requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act (FQPA) of 1996.

DATES: This regulation is effective September 20, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0238, 
must be received on or before November 19, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket ID number OPP-2002-0238 in the 
subject line on the first page of your response.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to 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.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0238. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of May 1, 2002 (67 FR 21676) (FRL-6834-7) 
and August 22, 2001 (66 FR 44136) (FRL- 6794-6) , EPA issued notices 
pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the 
FQPA (Public Law 104-170), announcing the filing of pesticide petitions 
(PP 2E6356, 2E6372, 2E6375, and 2E6376) by IR-4, 681 U.S. Highway 
1 South, North Brunswick, NJ 08902-3390 and 0F6218 by Syngenta 
Crop Protection, Inc., 410 Swing Road, P.O. Box 18300, Greensboro, NC 
27409-8300. These notices included summaries of the petitions prepared 
by Syngenta Crop Protection, the registrant. There were no comments 
received in response to the notices of filing.
    The petitions requested that 40 CFR 180.507 be amended by 
establishing tolerances for combined residues of the fungicide 
azoxystrobin, methyl(E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate and the Z-isomer of azoxystrobin, 
methyl(Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxyphenyl)-3- 
methoxyacrylate, in or on food commodities as follows:
    1. PP 2E6356 proposed a tolerance for the caneberry subgroup at 5.0 
ppm.
    2. PP 2E6372 proposed to increase the established tolerance for 
pistachio from 0.02 ppm to 1.0 ppm. The petition was subsequently 
revised to propose a tolerance for pistachio at 0.50 ppm.
    3. PP 2E6376 proposed a tolerance for cranberry at 0.50 ppm.
    4. PP 0F6218 proposed tolerances for the vegetable, legume, group 
at 3.0 ppm; hop, dried cones at 50 ppm. The petition was subsequently 
revised to propose tolerances for the vegetable, legume, edible podded 
subgroup, except soybean at 3.0 ppm; pea and bean, succulent shelled, 
subgroup, except cowpea at 0.50 ppm; pea and bean, dried shelled, 
except soybean subgroup, except cowpea and field pea at 0.50; and hop, 
dried cones at 20.0 ppm.

[[Page 59170]]

    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for tolerances for combined residues of azoxystrobin and its 
Zisomer on caneberry subgroup at 5.0 ppm; cranberry at 0.50 ppm; hop, 
dried cones, at 20.0 ppm; pistachio at 0.50 ppm; vegetable, legume, 
edible podded, subgroup, except soybean at 3.0 ppm; pea and bean, 
succulent shelled, subgroup, except cowpea at 0.50 ppm; pea and bean, 
dried shelled, except soybean subgroup, except cowpea and field pea at 
0.50. EPA's assessment of exposures and risks associated with 
establishing the tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by azoxystrobin is 
discussed in Unit III.A. of the Federal Register of September 29, 2000 
(65 FR 58404) (FRL-6749-1).

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology Q* is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (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 Dose and Endpoints for Azoxystrobin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  FQPA SF and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (general population      NOAEL = <200 mg/kg/day   FQPA SF = 1X             Acute Neurotoxicity -
 including infants and children)       UF = 300...............  aPAD = acute RfD/FQPA     Rat
                                       Acute RfD = 0.7 mg/kg/    SF.                     LOAEL = 200 mg/kg based
                                        day.                    = 0.67 mg/kg/day.......   on diarrhea at 2 hours
                                                                                          post dose at all dose
                                                                                          levels up to and
                                                                                          including the LOAEL
----------------------------------------------------------------------------------------------------------------

[[Page 59171]]

 
Chronic dietary (all populations)      NOAEL= 18 mg//kg/day     FQPA SF = 1X             Combined Chronic
                                       UF = 100...............  cPAD = chronic RfD/FQPA   Toxicity/
                                       Chronic RfD = 0.18 mg/    SF.                      Carcinogenicity
                                        kg/day.                 = 0.18 mg/kg/day.......  Feeding study - Rat
                                                                                          LOAEL in males/females
                                                                                          = 34/117 mg/kg/day
                                                                                          based on reduced body
                                                                                          weights in both sexes
                                                                                          and bile duct lesions
                                                                                          in males
----------------------------------------------------------------------------------------------------------------
Short-term (1-7 days) Incidental Oral  NOAEL= 25 mg//kg/day     FQPA SF = 1X             Prenatal Developmental
 (Residential)                         UF = 100...............                            Oral Toxicity - Rat
                                                                                          LOAEL = 100 mg/kg/day
                                                                                          based on increased
                                                                                          maternal diarrhea,
                                                                                          urinary incontinence,
                                                                                          and salivation
----------------------------------------------------------------------------------------------------------------
Intermediate-term (1 week to several   NOAEL= 21 mg//kg/day     FQPA SF = 1X             90-Day Feeding - Rat
 months) incidental oral               UF = 100...............                           LOAEL = 211/223 mg/kg/
(Residential)........................                                                     day in males/females
                                                                                          based on decreased
                                                                                          body weight gain in
                                                                                          both sexes and
                                                                                          clinical signs
                                                                                          indicative of reduced
                                                                                          nutrition
----------------------------------------------------------------------------------------------------------------
Short-term, intermediate-term, and     None                     No dermal or systemic    21-Day Repeated Dose
 long-term dermal (Residential)                                  toxicity was seen at     Dermal - Rat
                                                                 the limit dose (1,000
                                                                 mg/kg/day). This risk
                                                                 assessment was not
                                                                 performed.
----------------------------------------------------------------------------------------------------------------
Short-term (1-7 days) inhalation       Oral NOAEL= 25 mg/kg/    LOC for MOE = 100        Prenatal Developmental
 (Residential)                          day                     (Residential)..........   Oral Toxicity - Rat
                                       Use route-to-route                                LOAEL = 100 mg/kg/day
                                        extrapolation                                     based on increased
                                        (inhalation absorption                            maternal diarrhea,
                                        rate = 100%)..                                    urinary incontinence,
                                                                                          and salivation
----------------------------------------------------------------------------------------------------------------
Intermediate-term (1 week to several   Oral NOAEL= 21 mg/kg/    LOC for MOE = 100        90-Day Feeding - Rat
 months) inhalation                     day                     (Residential)..........  LOAEL = 211/223 mg/kg/
(Residential)........................  Use route-to-route                                 day in males/females
                                        extrapolation                                     based on decreased
                                        (inhalation absorption                            body weight gain in
                                        rate = 100%)..                                    both sexes and
                                                                                          clinical signs
                                                                                          indicative of reduced
                                                                                          nutrition
----------------------------------------------------------------------------------------------------------------
Long-term (greater than 180 days)      NOAEL = N/A              This risk assessment is
 inhalation                                                      not applicable to the
                                                                 use scenario for
                                                                 azoxystrobin
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.507) for the combined residues of azoxystrobin 
and its Zisomer, 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. Time-limited tolerances (set to expire on December 31, 2003) are 
established at 30 ppm for the Brassica, head and stem subgroup; at 0.5 
ppm for chick pea, seed; at 3.0 ppm for lychee; and at 2.0 ppm for 
pepper. Risk assessments were conducted by EPA to assess dietary 
exposures from azoxystrobin in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1 day or 
single exposure. The Dietary Exposure Evaluation Model (DEEM\TM\) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the acute 
exposure assessments: 100% of the crops with azoxystrobin tolerances 
(established and recommended) are treated and that all commodities 
contain tolerance level residues when consumed (with the exception of 
those with processing factors). DEEM\TM\ default processing/
concentration factors were used for all processed commodities.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment, the Dietary Exposure Evaluation Model (DEEM\TM\) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1989-1992 nationwide CSFII and accumulated exposure to the 
chemical for each commodity. The following assumptions were made for 
the chronic exposure assessments: 100% of the crops with azoxystrobin 
tolerances (established and recommended) are treated and that all 
commodities contain

[[Page 59172]]

tolerance level residues when consumed (with the exception of those 
with processing factors). DEEM\TM\ default processing/concentration 
factors were used for all processed commodities.
    iii. Cancer. Azoxystrobin was classified by the Agency as not 
likely to be a human carcinogen. Therefore, a cancer dietary exposure 
analysis was not performed.
    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 SCI-GROW model is used to predict pesticide 
concentrations in shallow ground water. For a screening-level 
assessment for surface water, EPA will use FIRST (a tier 1 model) 
before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset 
of the PRZM/EXAMS model that uses a specific high-end runoff scenario 
for pesticides. While both FIRST and PRZM/EXAMS incorporate an index 
reservoir environment, the PRZM/EXAMS model includes a percent crop 
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 screen for sorting out pesticides for which it is 
highly unlikely that drinking water concentrations would 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.
    Although moderately persistent in soils and stable to hydrolysis, 
the likelihood of azoxystrobin moving into ground water and surface 
water is low due to high soil/water partitioning coefficients and low 
single application rates. Three major degradates were detected and 
found to have greater potential to move through soil than the parent 
compound.
    Based on the FIRST model, the estimated environmental 
concentrations (EECs) of azoxystrobin for acute and chronic exposures 
are estimated to be 170 parts per billion (ppb), and 33 ppb for surface 
water, respectively. Based on the SCI-GROW model the EECs of 
azoxystrobin for both acute and chronic exposures are estimated to be 
3.1 ppb for ground water. These values were based on the highest use 
rate (turf use). These values represent upper-bound estimates of the 
concentrations that might be found in surface water and 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 the following 
residential non-dietary sites: turf and ornamentals. The risk 
assessment was conducted using the following residential exposure 
assumptions: Products containing azoxystrobin are registered for 
application to turf and ornamentals. They may be applied to turf at 
rates up to 0.95 lb active ingredient (ai) per acre (not to exceed 5 lb 
ai/acre/yr) and to ornamentals at rates up to 0.75 lb/ai/per acre every 
7 to 14 days, but not to exceed 5 lb ai/acre/yr. The currently 
registered labels do not prohibit homeowners from mixing/loading/
applying either the flowable concentrate or the water-dispersible 
granule formulations. This residential exposure and risk assessment was 
conducted using the application rate for turf because it is the highest 
single use rate.
    Residential handlers may receive short-term dermal and inhalation 
exposure to azoxystrobin when mixing, loading, and applying the 
formulations. Adults and children may be exposed to azoxystrobin 
residues from dermal contact with foliage during post-application 
activities. Toddlers may receive short- and intermediate-term oral 
exposure from incidental ingestion during post-application activities.
    As no dermal endpoint was selected by the Agency, a dermal exposure 
and risk assessment was not conducted for residential handlers or post-
application activities.
    Therefore, only the following exposure scenarios resulting from 
lawn treatment were assessed: (1) Toddlers' incidental ingestion of 
pesticide residues on lawns from hand-to-mouth transfer, (2) object-to-
mouth transfer from mouthing of pesticide-treated turfgrass, and (3) 
incidental ingestion of soil from pesticide-treated residential areas, 
(4) short-term inhalation for residential handlers. Post-application 
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 exposure and risk estimates for the post-application 
residential exposure scenarios are assessed for the day of application 
(day 0) because it is assumed that toddlers could contact the lawn 
immediately after application. Both short-term and intermediate-term 
exposure are expected. Risk from short-term and intermediate-term 
incidental ingestion by toddlers is assessed by comparing these 
exposures to the NOAELs of 25 milligrams/kilogram/day (mg/kg/day) and 
21 mg/kg/day, respectively. Short-term adult handler risk is assessed 
by comparing exposure to the short-term inhalation NOAEL of 25 mg/kg/
day.
    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

[[Page 59173]]

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

    1. 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.
    2. Prenatal and postnatal sensitivity. The developmental and 
reproductive toxicity data, from a prenatal development study in rats, 
a prenatal development study in rabbits, and a two-generation 
reproductive toxicity study in rats, did not indicate increased 
susceptibility of young rats or rabbits to in utero and/or postnatal 
exposure.
    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 10X safety factor to protect infants and children should be 
removed. The FQPA factor is removed because: (1) The toxicology data 
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.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP 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, OPP 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 12% of the aPAD for the U.S. population, 12% 
of the aPAD for females (13-50 years old), 21% of the aPAD for children 
(1-6 years old), and 12% of the aPAD for seniors (55+ years). 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 water and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the aPAD, as shown in the 
following Table 2:

                     Table 2.--Aggregate Risk Assessment for Acute Exposure to Azoxystrobin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                          0.7           12          170          3.1       21,000
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                 0.7           21          170          3.1        5,300
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                                0.7           12          170          3.1       18,000
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years)                                      0.7           12          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 13% of the cPAD for the U.S. 
population, 21% of the cPAD for children (1-6 years old), 12% of the 
cPAD for females (13-50 years old), and 14% of the cPAD for seniors 
(55+ 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 3:

[[Page 59174]]



             Table 3.-- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Azoxystrobin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                         0.18           13           33          3.1        5,500
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                0.18           21           33          3.1        1,400
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                               0.18           12           33          3.1        4,800
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years)                                     0.18           14           33          3.1        5,400
----------------------------------------------------------------------------------------------------------------

    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). The short-term 
aggregate risk assessment estimates risks likely to result from 1- to 
30-day exposure to azoxystrobin residues from food, drinking water, and 
residential pesticide uses. High-end estimates of residential exposure 
are used in the short-term assessment, while average values are used 
for food and drinking water exposure.
    A short-term risk assessment is required for adults because there 
is a residential handler inhalation exposure scenario. In addition, a 
short-term risk assessment is required for infants and children because 
there is a residential post-application oral exposure scenario. As no 
short-term dermal endpoint was established, there is no dermal 
component to this aggregate risk assessment.
    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 1,100 for adults and 450 for 
children (1-6 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 
water and surface water. After calculating DWLOCs and comparing them to 
the EECs for surface water and ground water, EPA does not expect short-
term aggregate exposure to exceed the Agency's level of concern, as 
shown in the following Table 4:

                   Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Azoxystrobin
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  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                                        1,100          100           33          3.1        6,800
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                 450          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). The 
intermediate-term aggregate risk assessment estimates risks likely to 
result from 1-6 months of exposure to azoxystrobin residues from food, 
drinking water, and residential pesticide uses. High-end estimates of 
residential exposure are used in the intermediate-term assessment, 
while average values are used for food and drinking water exposure.
    An intermediate-term risk assessment is not required for adults 
because residential handler scenarios are not expected to occur for 
longer than a short-term timeframe. However, an intermediate-term risk 
assessment is required for infants and children because there is a 
residential post-application oral exposure scenario. As no dermal 
endpoint was established, there is no dermal component to this 
aggregate risk assessment.
    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 440 for 
children 1-6 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 water and 
surface water. After calculating DWLOCs and comparing them to the EECs 
for surface water and ground water, EPA does not expect intermediate-
term aggregate exposure to exceed the Agency's level of concern, as 
shown in the following Table 5:

[[Page 59175]]



               Table 5.-- 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 (1-6 years old)                               440          100           33          3.1         1,600
----------------------------------------------------------------------------------------------------------------

    5. Aggregate cancer risk for U.S. population. Azoxystrobin was 
classified by EPA as not likely to be a human carcinogen. The Agency 
concludes that pesticides uses of azoxystrobin are not likely to pose a 
carcinogenic hazard to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to azoxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methodology is available for enforcement of the proposed 
tolerances for azoxystrobin and its z-isomer on plants. An enforcement 
method for azoxystrobin in livestock commodities has been validated by 
the EPA analytical laboratory for the analysis of milk and livestock 
tissues.
    The method may be requested from: Paul Golden, US EPA/OPP/BEAD/ACB, 
Environmental Science Center, 701 Mapes Road, Fort Meade, MD 20755-
5350; telephone number: (410) 305-2960; Fax: (410) 305-3091; e-mail 
address: RAM Mailbox.

B. International Residue Limits

    No Codex, Canadian, or Mexican maximum residue limits (MRLs) have 
been established for residues of azoxystrobin on caneberries, 
cranberries, pistachios, hops, or legumes.

V. Conclusion

    Therefore, the tolerances are established for combined residues of 
azoxystrobin, methyl(E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate and the z-isomer of azoxystrobin, 
methyl(Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxyphenyl)-3- 
methoxyacrylate, in or on caneberry subgroup at 5.0 ppm; cranberry at 
0.50 ppm; hop, dried cones at 20.0 ppm; pistachio at 0.5 ppm; 
vegetable, legume, edible podded, subgroup, except soybean at 3.0 ppm; 
pea and bean, succulent shelled, subgroup, except cowpea at 0.50 ppm; 
and pea and bean, dried shelled, except soybean subgroup, except cowpea 
and field pea at 0.50.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2002-0238 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before November 
19, 2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [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.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy

[[Page 59176]]

of your request to the PIRIB for its inclusion in the official record 
that is described in Unit I.B.2. Mail your copies, identified by docket 
ID number OPP-2002-0238, 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: [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. Regulatory Assessment Requirements

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

VIII. Submission to Congress and the Comptroller General

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

List of Subjects in 40 CFR Part 180

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


    Dated: September 13, 2002.
Richard P. Keigwin, Jr.,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

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

    Authority: 21 U.S.C. 321(q), 346(a) and 374.

    2. Section 180.507 is amended by revising the entry for pistachio 
and alphabetically adding the following

[[Page 59177]]

 commodities to the table in paragraph (a) to read as follows:


Sec.  180.507   Azoxystrobin; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Caneberry subgroup.............................                      5.0
Cranberry......................................                     0.50
                                * * * * *
Hops, dried cones..............................                     20.0
                                * * * * *
Pea and bean, dried shelled, except soybean,                        0.50
 subgroup, except cowpea, and field pea........
Pea and bean, succulent shelled, subgroup,                          0.50
 except cowpea.................................
Pistachio......................................                     0.50
                                * * * * *
Vegetable, legume, edible podded, subgroup,                          3.0
 except soybean................................
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 02-23808 Filed 9-19-02; 8:45 am]
BILLING CODE 6560-50-S