[Federal Register Volume 66, Number 184 (Friday, September 21, 2001)]
[Rules and Regulations]
[Pages 48585-48593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23607]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301174; FRL-6803-1]
RIN 2070-AB78


Azoxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

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

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

FOR FURTHER INFORMATION CONTACT: By mail: Hoyt Jamerson, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; 
telephone number: (703) 308-9368; and e-mail address: 
[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.'' A frequently updated electronic version of 40 CFR part 180 
is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301174. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

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

[[Page 48586]]

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

III. Aggregate Risk Assessment and Determination of Safety

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

A. Toxicological Profile

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

B. Toxicological Endpoints

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

[[Page 48587]]



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

C. Exposure Assessment

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

[[Page 48588]]

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

[[Page 48589]]

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

D. Safety Factor for Infants and Children

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

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
azoxystrobin will occupy 11% of the aPAD for the U.S. population, 11% 
of the aPAD for females 13 years and older, and 20% of the aPAD for 
children 1 to 6 years, the subpopulation at greatest exposure. In 
addition, there is potential for acute dietary exposure to azoxystrobin 
in drinking water. After calculating DWLOCs and comparing them to the 
EECs for surface and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the aPAD, as shown in the following Table 2:

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

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
azoxystrobin from food will utilize 12% of the cPAD for the U.S. 
population, 11% of the cPAD for females 13 to 50 years, and 18% of the 
cPAD for children 1 to 6 years, the subpopulation at greatest exposure. 
Based on the use pattern, chronic residential exposure to residues of 
azoxystrobin is not expected. In addition, there is potential for 
chronic dietary exposure to azoxystrobin in drinking water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in the following Table 3:

[[Page 48590]]



              Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Azoxystrobin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                         0.18           12           33         0.06        5,600
----------------------------------------------------------------------------------------------------------------
Females (13 to 50 years)                                0.18           11           33         0.06        4,800
----------------------------------------------------------------------------------------------------------------
Children (1 to 6 years)                                 0.18           18           33         0.06        1,500
----------------------------------------------------------------------------------------------------------------
Seniors 55+ years                                       0.18           12           33         0.06        5,600
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Azoxystrobin is 
currently registered for use that could result in short-term 
residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic food and water and short-term 
exposures for azoxystrobin. A short-term risk assessment is required 
for adults because there is a residential handler inhalation exposure 
scenario. In addition, a short-term risk assessment is required for 
infants and children because there is a residential post-application 
oral exposure scenario. As no short-term or intermediate-term dermal 
endpoint was established, there is no dermal component to these 
aggregate risk assessments. For adults, the daily inhalation dose is 
aggregated with the chronic exposure to food and water. For infants and 
children, the incidental oral exposure from residential post-
application activities for infants and children was aggregated with 
chronic exposure from food and water.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 1,183 for adults and 490 for 
children 1 to 6 years. These aggregate MOEs do not exceed the Agency's 
level of concern for aggregate exposure to food and residential uses. 
In addition, short-term DWLOCs were calculated and compared to the EECs 
for chronic exposure of azoxystrobin in ground and surface water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect short-term aggregate exposure to 
exceed the Agency's level of concern, as shown in the following Table 
4:

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

    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Azoxystrobin 
is currently registered for use(s) that could result in intermediate-
term residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic food and water and intermediate-term 
exposures for azoxystrobin. An intermediate-term risk assessment is not 
required for adults because residential handler scenarios are not 
expected to occur for longer than a short-term timeframe. However, an 
intermediate-term risk assessment is required for infants and children 
because of the residential post-application oral exposure scenario. As 
no dermal endpoint was established, there is no dermal component to 
this aggregate risk assessment. As was necessary for the short-term 
aggregate assessment, the incidental oral exposure from residential 
post application activities for infants and children was aggregated 
with average exposure from food and water.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food and 
residential exposures aggregated result in an aggregate MOE of 580 for 
children 1 to 6 years. This aggregate MOE does not exceed the Agency's 
level of concern for aggregate exposure to food and residential uses. 
In addition, intermediate-term DWLOCs were calculated and compared to 
the EECs for chronic exposure of azoxystrobin in ground and surface 
water. After calculating DWLOCs and comparing them to the EECs for 
surface and ground water, EPA does not expect intermediate-term 
aggregate exposure to exceed the Agency's level of concern, as shown in 
the following Table 5:

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


[[Page 48591]]

    5. Aggregate cancer risk for U.S. population. Azoxystrobin is 
classified as ``not likely to be carcinogenic in humans'' based on the 
results of carcinogenicity studies in mice and rats. Therefore, 
azoxystrobin is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to azoxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

    No Codex, Canadian, or Mexican maximum residue levels have been 
established for residues of azoxystrobin in or on these commodities. 
Therefore, no tolerance discrepancies exist between countries for this 
chemical.

V. Conclusion

    Therefore, the tolerances are established for combined residues of 
azoxystrobin, methyl (E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate) and its Z-isomer (methyl (Z)-2-(2-(6-
(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate, in or on 
acerola at 2.0 ppm, atemoya at 2.0 ppm, avocado at 2.0 ppm, biriba at 
2.0 ppm, black sapote at 2.0 ppm, bushberry subgroup at 3.0 ppm, 
canistel at 2.0 ppm, cherimoya at 2.0 ppm, custard apple at 2.0 ppm, 
eggplant at 2.0 ppm, feijoa at 2.0 ppm, grass forage at 15 ppm, grass 
hay at 20 ppm, guava at 2.0 ppm, ilama at 2.0 ppm, jaboticaba at 2.0 
ppm, jackfruit at 2.0 ppm, juneberry at 3.0 ppm, leafy greens 
(Brassica) subgroup at 25 ppm, lingonberry at 3.0 ppm, longan at 2.0 
ppm, loquat at 2.0 ppm, lychee at 2.0 ppm, mamey sapote at 2.0 ppm, 
mango at 2.0 ppm, okra at 2.0 ppm, passion fruit at 2.0 ppm, pawpaw at 
2.0 ppm, papaya at 2.0 ppm, pepper at 2.0 ppm, peppermint (tops) at 30 
ppm, persimmon at 2.0 ppm, pulasan at 2.0 ppm, rambutan at 2.0 ppm, 
salal at 3.0 ppm, sapodilla at 2.0 ppm, soursop at 2.0 ppm, Spanish 
lime at 2.0 ppm, spearmint, tops at 30 ppm, star apple at 2.0 ppm, 
starfruit at 2.0 ppm, strawberry at 10 ppm, sugar apple at 2.0 ppm, 
tamarind at 2.0 ppm, turnip (tops) at 25 ppm, watercress at 3.0 ppm, 
wax jambu at 2.0 ppm, white sapote at 2.0 ppm.

VI. Objections and Hearing Requests

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

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

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

[[Page 48592]]

Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460. In person or by courier, bring a copy 
to the location of the PIRIB described in Unit I.B.2. You may also send 
an electronic copy of your request via e-mail to: [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 tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any other Agency action under 
Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997). This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note). Since tolerances and exemptions that are established on the 
basis of a petition under FFDCA section 408(d), such as the tolerances 
in this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications. 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Submission to Congress and the Comptroller General

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

List of Subjects in 40 CFR Part 180

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


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


    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

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


Sec. 180.507  Azoxystrobin; tolerances for residues.

    (a) * * *

[[Page 48593]]



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

* * * * *

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