[Federal Register Volume 65, Number 190 (Friday, September 29, 2000)]
[Rules and Regulations]
[Pages 58404-58414]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25051]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301069; FRL-6749-1]
RIN 2070-AB78


Azoxystrobin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for the 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 barley, bran at 0.2 parts per million (ppm); barley, grain at 0.1 
ppm; barley, hay at 15.0 ppm; barley, straw at 4.0 ppm; citrus, dried 
pulp at 2.0 ppm; citrus, oil at 4.0 ppm; coriander, leaves at 30.0 ppm; 
corn, field, forage at 12.0 ppm; corn, field, grain at 0.05 ppm; corn, 
field, refined oil at 0.3 ppm; corn, field, stover at 25.0 ppm; corn, 
pop, grain at 0.05 ppm; corn, pop, stover at 25.0 ppm; corn, sweet, 
forage at 12.0 ppm; corn, sweet (kernels plus cob with husks removed) 
at 0.05 ppm; corn, sweet, stover at 25.0 ppm; cotton, gin byproducts at 
0.02 ppm; cotton, undelinted seed at 0.02 ppm; fruit, citrus, group at 
1.0 ppm; grain, aspirated grain fractions at 30.0 ppm; onion, dry bulb 
at 1.0 ppm; onion, green at 7.5 ppm; peanut at 0.2 ppm; peanut, refined 
oil at 0.6 ppm; peanut, hay at 15.0 ppm; soybean, forage at 25.0 ppm; 
soybean, hay at 55.0 ppm; soybean, hulls at 1.0 ppm; soybean, seed at 
0.5 ppm; vegetable, leafy, except Brassica, group at 30.0 ppm; 
vegetable, leaves of root and tuber, group at 50.0 ppm; vegetable, 
root, subgroup at 0.5 ppm; and vegetable, tuberous and corm, subgroup 
at 0.03 ppm; and increases the tolerance for azoxystrobin (only) in or 
on cattle, fat to 0.03 ppm; cattle, meat byproducts to 0.07 ppm; goat, 
fat to 0.03 ppm; goat, meat byproducts to 0.07 ppm; horse, fat to 0.03 
ppm; horse, meat byproducts to 0.07 ppm; sheep, fat to 0.03 ppm; and 
sheep, meat byproducts to 0.07 ppm. Zeneca Ag Products requested these 
tolerances in pesticide petition number (PP#) 9F6058 under the Federal 
Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection 
Act of 1996.

DATES: This regulation is effective September 29, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301069, 
must be received by EPA on or before November 28, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301069 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT By mail: Dan Kenny, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; 
telephone number: (703)305-7546; 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            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/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly

[[Page 58405]]

to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301069. 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 August 2, 2000 (65 FR 47498) (FRL-6592-
1), 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 a pesticide petition (PP) for tolerance by Zeneca Ag 
Products, 1800 Concord Pike, P.O. Box 15458, Wilmington, DE 19850--
5458. This notice included a summary of the petition prepared by Zeneca 
Ag Products, the registrant. There were no comments received in 
response to the notice of filing.
    The petition requested that 40 CFR 180.507 be amended by 
establishing a tolerance 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 
barley, bran at 0.2 ppm; barley, grain at 0.1 ppm; barley, hay at 15 
ppm; barley, straw at 4 ppm; citrus, dried pulp at 2.0 ppm; citrus, oil 
at 4.0 ppm; coriander, leaves at 30 ppm; corn, field, forage at 12 ppm; 
corn, field, grain at 0.05 ppm; corn, field, refined oil at 0.3 ppm; 
corn, field, stover at 25 ppm; corn, pop, grain at 0.05 ppm; corn, pop, 
stover at 25 ppm; corn, sweet, forage at 12 ppm; corn, sweet, kernel 
plus cob with husks removed at 0.05 ppm; corn, sweet, stover at 25 ppm; 
cotton, gin byproducts at 0.02 ppm; cotton, undelinted seed at 0.02 
ppm; fruit, citrus, group at 1.0 ppm; onion, dry bulb at 1.0 ppm; 
onion, green at 7.5 ppm; peanut at 0.2 ppm; peanut, hay at 15.0 ppm; 
peanut, refined oil at 0.6 ppm; soybean, forage at 25 ppm; soybean, hay 
at 55 ppm; soybean, hulls at 1.0 ppm; soybean, seed at 0.5 ppm; 
vegetable, leafy, except Brassica, group at 30 ppm; vegetable, leaves 
of root and tuber, group at 50 ppm; and vegetable, root, subgroup at 
0.5 ppm; and vegetable, tuberous and corm, subgroup at 0.03 ppm; and 
increase the tolerances for residues of azoxystrobin (only) in or on 
cattle, fat to 0.03 ppm; cattle, meat byproducts to 0.07 ppm; goat, fat 
to 0.03 ppm; goat, meat byproducts to 0.07 ppm; horse, fat to 0.03 ppm; 
horse, meat byproducts to 0.07 ppm; sheep, fat to 0.03 ppm; and sheep, 
meat byproducts to 0.07 (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 the 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) on barley, 
bran at 0.2 ppm; barley, grain at 0.1 ppm; barley, hay at 15.0 ppm; 
barley, straw at 4.0 ppm; citrus, dried pulp at 2.0 ppm; citrus, oil at 
4.0 ppm; coriander, leaves at 30.0 ppm; corn, field, forage at 12.0 
ppm; corn, field, grain at 0.05 ppm; corn, field, refined oil at 0.3 
ppm; corn, field, stover at 25.0 ppm; corn, pop, grain at 0.05 ppm; 
corn, pop, stover at 25.0 ppm; corn, sweet, forage at 12.0 ppm; corn, 
sweet (kernels plus cob with husks removed) at 0.05 ppm; corn, sweet, 
stover at 25.0 ppm; cotton, gin byproducts at 0.02 ppm; cotton, 
undelinted seed at 0.02 ppm; fruit, citrus, group at 1.0 ppm; grain, 
aspirated grain fractions at 30.0 ppm; onion, dry bulb at 1.0 ppm; 
onion, green at 7.5 ppm; peanut at 0.2 ppm; peanut, refined oil at 0.6 
ppm; peanut, hay at 15.0 ppm; soybean, forage at 25.0 ppm; soybean, hay 
at 55.0 ppm; soybean, hulls at 1.0 ppm; soybean, seed at 0.5 ppm; 
vegetable, leafy, except Brassica, group at 30.0 ppm; vegetable, leaves 
of root and tuber, group at 50.0 ppm; vegetable, root, subgroup at 0.5 
ppm; and vegetable, tuberous and corm, subgroup at 0.03 ppm; and to 
increase the tolerances for residues of azoxystrobin (only) in or on 
cattle, fat to 0.03 ppm; cattle, meat byproducts to 0.07 ppm; goat, fat 
to 0.03 ppm; goat, meat byproducts to 0.07 ppm; horse, fat to 0.03 ppm; 
horse, meat byproducts to 0.07 ppm; sheep, fat to 0.03 ppm; and sheep, 
meat byproducts to 0.07 ppm. EPA's assessment of exposures and risks 
associated with establishing or increasing 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, as 
well as the no observed adverse effect level (NOAEL) and the lowest 
observed adverse effect level (LOAEL) from the toxicity studies 
reviewed, are discussed in the following Table 1.

[[Page 58406]]



                                Table 1.--Subchronic, Chronic, and Other Toxicity
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              Guideline No.                         Study Type                           Results
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870.3100                                   90-Day oral toxicity in      NOAEL = 20.4 mg/kg/day for both males
                                            rodents                      and females
                                                                        LOAEL = 211.0 mg/kg/day based on
                                                                         decreased body weight gain in both
                                                                         sexes, clinical observations of
                                                                         distended abdomens, reduced body size,
                                                                         and clinical pathology findings
                                                                         atributable to reduced nutritional
                                                                         status.
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870.3150                                   90-Day oral toxicity in      NOAEL = 50 mg/kg/day
                                            nonrodents
                                                                        LOAEL = 250 mg/kg/day based on treatment-
                                                                         related clinical observations and
                                                                         clinical chemistry alterations .
----------------------------------------------------------------------------------------------------------------
870.3250                                   21-Day dermal toxicity       NOAEL = greater than or equal to 1,000
                                                                         mg/kg/day (the highest dosing regimen)
                                                                        LOAEL = was not determined.
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870.3700a                                  Prenatal developmental in    Maternal NOAEL = not established
                                            rodents
                                                                        Maternal LOAEL = 25 mg/kg/day based on
                                                                         increased salivation.
                                                                        Developmental NOAEL = greater than or
                                                                         equal to 100 mg/kg/day
                                                                        Developmental LOAEL = greater than 100
                                                                         mg/kg/day because no adverse effects
                                                                         were observed.
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870.3700b                                  Prenatal developmental in    Maternal NOAEL = 150 mg/kg/day
                                            nonrodents
                                                                        Maternal LOAEL = 500 mg/kg/day based on
                                                                         decreased body weightgain.
                                                                        Developmental NOAEL = 500 mg/kg/day
                                                                        Developmental LOAEL = greater than 500
                                                                         mg/kg/day because no treatment-related
                                                                         adverse effects on development were
                                                                         seen.
----------------------------------------------------------------------------------------------------------------
870.3800                                   Reproduction and fertility   Reproductive NOAEL = 32.2 mg/kg/day
                                            effects
                                                                        Reproductive LOAEL = 165.4 mg/kg/day
                                                                         based on treatment-related reductions
                                                                         in adjusted pup body weights that were
                                                                         observed in the F1a and F2a pups.
----------------------------------------------------------------------------------------------------------------
870.4100a                                  Chronic toxicity rodents     NOAEL = 18.2 mg/kg/day for males and
                                                                         22.3 mg/kg/day for females
                                                                        LOAEL = 34 mg/kg/day for males based on
                                                                         reduced body weights, food consumption
                                                                         and food efficiency, and bile duct
                                                                         lesions and 117.1 mg/kg/day for females
                                                                         based on reduced body weights.
----------------------------------------------------------------------------------------------------------------
870.4100b                                  Chronic toxicity dogs        NOAEL = 25 mg/kg/day
                                                                        LOAEL = 200 mg/kg/day based on clinical
                                                                         observations, clinical chemistry
                                                                         changes, and liver weight increases in
                                                                         both sexes.
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870.4200                                   Carcinogenicity in rats      Systemic toxicity NOAEL = 18.2 mg/kg/day
                                                                         for males and 22.3 mg/kg/day for
                                                                         females
                                                                        Systemic toxicity LOAEL = 34 mg/kg/day
                                                                         for males based on reduced body
                                                                         weights, food consumption and food
                                                                         efficiency, and bile duct lesions and
                                                                         117.1 mg/kg/day for females based on
                                                                         reduced body weights. There was no
                                                                         evidence of carcinogenicity.
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870.4300                                   Carcinogenicity in mice      Systemic toxicity NOAEL = 37.5 mg/kg/day
                                                                        Systemic toxicity LOAEL = 272.4 mg/kg/
                                                                         day based on reduced body weights in
                                                                         both males and females. There was no
                                                                         evidence of carcinogenicity.
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870.5100                                   Gene Mutation                Azoxystrobin was positive for forward
                                                                         gene mutation in mouse lymphoma cells,
                                                                         but was not mutagenic in the salmonella/
                                                                         mammalian activation gene mutation
                                                                         assay, showed some evidence of
                                                                         concentration-related induction of
                                                                         chromosomal aberrations over background
                                                                         in the presence of moderate to severe
                                                                         toxicity in the in vitro mammalian
                                                                         cytogenetics assay in human
                                                                         lymphocytes, caused no increase in the
                                                                         induction of micronuclei in the mouse
                                                                         bone marrow micronucleus assay, and did
                                                                         not increase the incidence of
                                                                         unscheduled DNA synthesis in rat
                                                                         hepatocytes/mammalian cells.
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870.6200a                                  Acute neurotoxicity          Systemic toxicity NOAEL = less than 200
                                            screening battery            mg/kg/day Systemic toxicity
                                                                        Systemic toxicity LOAEL = 200 mg/kg/day
                                                                         based on transient diarrhea in both
                                                                         sexes. There was no indication of
                                                                         neurotoxicity at the doses tested.
----------------------------------------------------------------------------------------------------------------
870.6200b                                  Subchronic neurotoxicity     Systemic toxicity NOAEL = 38.5 mg/kg/day
                                            screening battery
                                                                        Systemic toxicity LOAEL = 161 mg/kg/day
                                                                         based on decreased body weight and
                                                                         weight gain in both sexes. There were
                                                                         no consistent indications of treatment-
                                                                         related neurotoxicity.
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[[Page 58407]]

 
870.7485                                   Metabolism and pharma-       Metabolism studies were conducted with
                                            cokinetics                   azoxystrobin that was either unlabeled
                                                                         or was labeled on the pyrimidinyl,
                                                                         phenylacrylate, or cyanophenyl part of
                                                                         the molecule. Dosing was single or for
                                                                         a period of 14 days. Overall recovery
                                                                         of label was 92-104%. Absorption was
                                                                         widely distributed but less than 0.5%
                                                                         of the dose was detected in the tissues
                                                                         and carcass up to 7 days postdosing.
                                                                         Most absorbed azoxystrobin was in
                                                                         excretion-related organs, especially
                                                                         the liver and kidneys. There was no
                                                                         evidence of potential for
                                                                         bioaccumulation. Excretion via expired
                                                                         air was minimal. Most excretion, in
                                                                         both sexes, was via the feces (73-89%)
                                                                         and urine (9-18%). Absorbed
                                                                         azoxystrobin seemed to be metabolized.
                                                                         Except for metabolite V (a glucuronide
                                                                         conjugate), which represented 27.4-
                                                                         29.3% of the administered dose,
                                                                         individual biliary metabolites
                                                                         represented less than 10% of the
                                                                         administered dose. A metabolic pathway
                                                                         was proposed showing hydrolysis and
                                                                         subsequent glucuronide conjugation as
                                                                         the major biotransformation process.
                                                                         This study was considered supplementary
                                                                         but can be upgraded upon acceptable
                                                                         additional explanations of fecal
                                                                         excretion data and how they pertain to
                                                                         assessing absorption in the two low-
                                                                         dose studies.
----------------------------------------------------------------------------------------------------------------
870.7600                                   Dermal penetration           Doses of 0.01 to 13.3 mg/kg were used.
                                                                         No animals died as a result of the
                                                                         treatment. Percutaneous absorption was
                                                                         minimal and did not appear to exhibit a
                                                                         dose-response relationship. Limited
                                                                         absorption precluded accurate
                                                                         assessment of distribution and
                                                                         metabolite characterization. Both fecal
                                                                         and urinary excretion were quantified,
                                                                         the former representing ca. 6% or less
                                                                         of total absorption and the latter
                                                                         accounting for less than 0.1% of the
                                                                         absorbed dose over a 24-hour period.
----------------------------------------------------------------------------------------------------------------

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. No 
additional uncertainty factors were used in this assessment.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD), where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the 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). 
In certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment instead. 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 2:

     Table 2.--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 = less than 200    FQPA SF = 1; aPAD =      Acute Neurotoxicity in
 including infants and children         mg/kg/day; UF = 300;     acute RfD FQPA SF =      the Rat
                                        Acute RfD = 0.67 mg/kg/  0.67 mg/kg/day
                                        day
                                                                                         LOAEL = 200 mg/kg/day
                                                                                          based on transient
                                                                                          diarrhea in both sexes
----------------------------------------------------------------------------------------------------------------

[[Page 58408]]

 
Chronic Dietary all populations        NOAEL = 18.2 mg/kg/day;  FQPA SF = 1; cPAD =      Chronic/Carcinogenicity
                                        UF = 100; Chronic RfD    0.18 mg/kg/day chronic   Feeding Study in Rats
                                        = 0.18 mg/kg/day         RfD x FQPA SF = 0.18
                                                                 mg/kg/day
                                                                                         LOAEL = 34 mg/kg/day
                                                                                          for males based on
                                                                                          reduced body weights,
                                                                                          reduced food
                                                                                          consumption and food
                                                                                          efficiency, and bile
                                                                                          duct lesions and 117.1
                                                                                          mg/kg/day for females
                                                                                          based on reduced body
                                                                                          weights
----------------------------------------------------------------------------------------------------------------
Short-Term Incidental Oral             NOAEL = 25 mg/kg/day;    FQPA SF = 1              Prenatal Developmental
                                        UF = 100                                          Oral Toxicity in the
                                                                                          Rat
                                                                                         LOAEL = 100 mg/kg/day
                                                                                          based on increased
                                                                                          maternal diarrhea,
                                                                                          urinary incontinence,
                                                                                          and salivation
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Incidental Oral      NOAEL = 20 mg/kg/day;    FQPA SF = 1              90-Day Feeding Study in
                                        UF = 100                                          the Rat
                                                                                         LOAEL = 211 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight gain and
                                                                                          clinical signs
                                                                                          indicative of
                                                                                          malnutrition in both
                                                                                          sexes
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal                      NOAEL= not applicable    .......................  21-Day Repeated-Dose
                                                                                          Dermal in the Rat
                                                                                         LOAEL = not applicable
                                                                                          based on no dermal or
                                                                                          systemic effects seen
                                                                                          at the limit dermal
                                                                                          dose of 1000 mg/kg/
                                                                                          day. This risk
                                                                                          assessment is thus not
                                                                                          required.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal               NOAEL = not applicable   .......................  21-Day Repeated Dose
                                                                                          Dermal in the Rat
                                                                                         LOAEL = not applicable
                                                                                          based on no dermal or
                                                                                          systemic effects seen
                                                                                          at the limit dermal
                                                                                          dose of 1000 mg/kg/
                                                                                          day.This risk
                                                                                          assessment is thus not
                                                                                          required.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal                       NOAEL = not applicable   .......................  This risk assessment is
                                                                                          not required, based on
                                                                                          the use pattern.
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation                   NOAEL = 25 mg/kg/day    LOC for MOE = 100        Prenatal Development
                                        (route-to-route                                   Oral Toxicity in the
                                        extrapolation and 100%                            Rat
                                        absorption rate
                                        (default value) used)
                                                                                         LOAEL = 100 mg/kg/day
                                                                                          based on increased
                                                                                          maternal diarrhea,
                                                                                          urinary incontinence,
                                                                                          and salivation
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation           NOAEL = 20 mg/kg/day     LOC for MOE = 100        90-Day Feeding Study in
                                        (route-to-route                                   the Rat
                                        extrapolation and 100%
                                        absorption rate
                                        (default value) used)
                                                                                         LOAEL = 211 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight gain and
                                                                                          clinical signs
                                                                                          indicative of reduced
                                                                                          nutrition in both
                                                                                          sexes
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation                   NOAEL = not applicable   .......................  This risk assessment is
                                                                                          not applicable to the
                                                                                          use scenario of
                                                                                          azoxystrobin.
----------------------------------------------------------------------------------------------------------------
Cancer                                 .......................  .......................  Chronic/Carcinogenicity
                                                                                          Feeding Study in Rats;
                                                                                          Carcinogenicity
                                                                                          Feeding Study in Mice.
                                       .......................  .......................  There was no evidence
                                                                                          of carcinogenic
                                                                                          activity in either
                                                                                          study. This assessment
                                                                                          is thus not applicable
                                                                                          and azoxystrobin is
                                                                                          considered not likely
                                                                                          to be a human
                                                                                          carcinogen.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.


[[Page 58409]]

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 
(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 a 
variety of raw agricultural commodities. Tolerances for azoxystrobin 
(only) have also been established for the animal commodities fat (0.010 
ppm), meat byproducts (0.010 ppm), and meat (0.01 ppm) of cattle, 
goats, hogs, horses, and sheep; and for milk (0.006 ppm). Time-limited, 
emergency exemption tolerances have been established for azoxystrobin 
in/on several raw agriculutural commodities and animal commodities. 
Additional time-limited, emergency exemption azoxystrobin tolerances 
have also recently been recommended for carrots, roots (0.50 ppm); 
fruit, citrus, group (3.0 ppm); cotton, seed (0.10 ppm); beets, garden, 
roots (0.50 ppm); beets, garden, tops (50 ppm); and ginseng (0.50 ppm). 
Several of the time-limited tolerances will be replaced with permanent 
tolerances by this rule. Where both a time-limited and a permanent 
tolerance are proposed or established and where the tolerance values 
are not the same, the higher of the values was used in the dietary risk 
analysis. For the animal commodities whose azoxystrobin tolerances are 
proposed to be increased in PP#9F6058, the increased tolerance value 
was used in the dietary risk analysis. Risk assessments were conducted 
by EPA to assess dietary exposures from azoxystrobin in food as 
follows:
     i. Acute exposure. Acute dietary risk assessments are performed 
for a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. The Dietary Exposure Evaluation Model 
(DEEM) 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 DEEM 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 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 percent 
crop treated (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 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. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for azoxystrobin in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of azoxystrobin.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
Screening Concentration in Ground Water (SCI-GROW) to predict pesticide 
concentrations in ground water. In general, EPA will use GENEEC (a tier 
1 model) before using PRZM/EXAMS (a tier 2 model) for a screening-level 
assessment for surface water. The GENEEC model is a subset of the PRZM/
EXAMS model that uses a specific high-end runoff scenario for 
pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS 
incorporates an index reservoir environment in place of the previous 
pond scenario. The PRZM/EXAMS model includes a percent crop area factor 
as an adjustment to account for the maximum percent crop coverage 
within a watershed or drainage basin.
    None of these models include consideration of the impact of the 
processing (mixing, dilution, or treatment) of raw water for 
distribution that 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 GENEEC and SCI-GROW models the estimated environmental 
concentrations (EECs) of azoxystrobin for acute exposures are estimated 
to be 141 parts per billion (ppb) for surface water and 0.064 ppb for 
ground water. The EECs for chronic exposures are estimated to be 0.064 
ppb for surface water and 127 ppb for ground water. Agency policy 
allows the estimated chronic surface water concentrations to be divided 
by 3 to obtain the value that is used in chronic risk assessment 
calculations. Therefore, the value that will be used in this type of 
assessment for azoxystrobin is 42 ppb.
    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 1-5 times per year 
at rates up to 0.95 lb. of active ingredient per acre. The current 
registered labels permit homeowners to mix/load/apply both flowable 
(i.e., liquid) and water-dispersable granule formulations. Residential 
handlers may be exposed to azoxystrobin for both short-term and

[[Page 58410]]

intermediate-term durations. Toddlers may also receive short-term and 
intermediate-term oral exposure from hand-to-mouth ingestion during 
post-application activities. The Agency's Draft Standard Operating 
Procedures (SOPs) for Residential Exposure Assessments were used as the 
basis for all residential handler exposure calculations. The post-
application risk assessment is based on generic assumptions as 
specified by the newly proposed Residential SOPs and recommended 
approaches by the Agency's Exposure Science Advisory Committee. Changes 
to the Residential SOPs have been proposed that alter the residential 
post-application scenario assumptions. The proposed assumptions are 
expected to better represent residential exposure and are still 
considered to be high-end, screening level assumptions. Agency 
management has authorized the use of the revised residential SOPs that 
were presented to the FIFRA Science Advisory Panel in September 1999. 
Therefore, the current Residential SOP assumptions have been deviated 
from and the proposed assumptions have been used to calculate exposure 
estimates.
    The short-term and intermediate-term NOAELs of 25 mg/kg/day and 20 
mg/kg/day, derived from the Short-Term Inhalation and Intermediate-Term 
Inhalation scenarios (see above), respectively, were used in the 
inhalation and hand-to-mouth risk assessment of residential exposure. 
As no dermal endpoint was selected, a dermal risk assessment was not 
required for residential exposure. For residential inhalation and oral 
risk assessments, the target margin of exposure (MOE) was 100, which 
incorporates the FQPA Safety Factor of 1x.
    MOEs calculated for residential handlers' inhalation exposure and 
children's oral exposure were well above the target of 100.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether azoxystrobin has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
azoxystrobin does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that azoxystrobin has a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    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. 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.
    iii. Conclusion. There is a complete toxicity data base for 
azoxystrobin and exposure data are complete or are estimated based on 
data that reasonably account 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 database and the lack of 
increased susceptibility of young rats and rabbits to pre- 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 value, drinking 
water consumption, and body weights. The following default body weights 
and consumption values are used by the U.S. EPA Office of Water to 
calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, 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 11% of the aPAD for the U.S. population, 12% 
of the aPAD for females 13 years old and older and 19%

[[Page 58411]]

of the aPAD for infants and children. 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 3:

                     Table 3.--Aggregate Risk Assessment for Acute Exposure to Azoxystrobin
----------------------------------------------------------------------------------------------------------------
                                                                           Surface    Ground Water
                                               a PAD (mg/     % aPAD      Water EEC   EEC (g/     m>g/L)     (g/
                                                                             L)                          L)
----------------------------------------------------------------------------------------------------------------
U.S. population (total)                              0.67           11           141         0.064        21,000
----------------------------------------------------------------------------------------------------------------
Infants/children                                     0.67           19           141         0.064         5,400
----------------------------------------------------------------------------------------------------------------
Females 13+                                          0.67           12           141         0.064        18,000
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
azoxystrobin from food will utilize 12% of the cPAD for the U.S. 
population, 12% of the cPAD for females 13 years old and older, and 18% 
of the cPAD for children 1-6 years old. Based 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 4:

              Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Azoxystrobin
----------------------------------------------------------------------------------------------------------------
                                                                           Surface    Ground Water     Chronic
                                              cPAD mg/kg/     % cPAD      Water EEC   EEC (g/     m>g/L)     (g/
                                                                             L)                          L)
----------------------------------------------------------------------------------------------------------------
U.S. Population (total)                              0.18           12            42         0.064         5,600
----------------------------------------------------------------------------------------------------------------
Infants/children                                     0.18           18            42         0.064         1,500
----------------------------------------------------------------------------------------------------------------
Females 13+                                          0.18           12            42         0.064         4,800
----------------------------------------------------------------------------------------------------------------

    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 uses that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for azoxystrobin.
     Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 1,200 for the U.S. population 
and 520 for the subgroup 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 to 
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 5:

                   Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Azoxystrobin
----------------------------------------------------------------------------------------------------------------
                                                            Aggregate      Surface    Ground Water   Short-Term
                                               Aggregate     Level of     Water EEC   EEC (g/     m>g/L)     (g/
                                             Residential)     (LOC)          L)                          L)
----------------------------------------------------------------------------------------------------------------
U.S. population                                     1,200          100            42         0.064         6,900
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old                                520          100            42         0.064         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 uses 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 an aggregate MOE of 420 for 
the subgroup 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 
and surface water. After calculating DWLOCs and comparing them to the 
EECs for surface and ground

[[Page 58412]]

water, EPA does not expect intermediate-term aggregate exposure to 
exceed the Agency's level of concern, as shown in the following Table 
6:

               Table 6.--Aggregate Risk Assessment for Intermediate-Term Exposure to Azoxystrobin
----------------------------------------------------------------------------------------------------------------
                                                           Aggregate      Surface    Ground Water  Intermediate-
                                              Aggregate     Level of     Water EEC   EEC (g/     m>g/L)      (g/
                                            Residential)     (LOC)          L)                           L)
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old                               420          100            42         0.064         1,500
----------------------------------------------------------------------------------------------------------------

     5. Aggregate cancer risk for U.S. population. Because of the lack 
of evidence of any carcinogenic potential of azoxystrobin in long-term 
rat and mouse feeding studies, the Agency has classified it as not 
likely to be a human carcinogen and there are no endpoints or other 
values against which to assess carcinogenic risk. Therefore, this risk 
analysis is not applicable.
     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. The registrant has previously submitted three analytical 
methods for the analysis of commodities for which azoxystrobin 
tolerances exist.
    1. The first method, 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 such as barley, bran; barley, grain; barley, 
hay; barley, straw; citrus, dried pulp; coriander, leaves; corn, field, 
forage; corn, field, grain; corn, field, refined oil; corn, field, 
stover; corn, pop, grain; corn, pop, stover; corn, sweet, forage; corn, 
sweet (kernels plus cob with husks removed); corn, sweet, stover; 
fruit, citrus, group; onion, dry bulb; onion, green; peanut, hay; 
vegetable, leafy, except Brassica, group; vegetable, leaves of root and 
tuber, group; vegetable, root, subgroup; vegetable, tuberous and corm, 
subgroup; and non-oily processed 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.
    2. The second method, RAM 260, is a GC/NPD method previously 
submitted by the registrant for the analysis of azoxystrobin and its Z 
isomer in or on crops of high lipid content. It is adequate for the 
enforcement of tolerances such as cotton, undelinted seed; peanut; 
soybean, seed; and oily processed commodities. This method has also 
been validated by the Agency and will be submitted to FDA for inclusion 
in PAM II.
    3. The third method, RAM 255/01, also previously submitted by the 
registrant, uses gas chromatography with thermionic protection, 
nitrogen mode, for analysis of animal commodities, including the fat 
and meat byproducts of cattle, goat, horse, and sheep. This method, as 
well, has been validated by the Agency for analysis of milk and animal 
tissues. This method, which will be accompanied by a written laboratory 
report and an Agency addendum, are to be submitted to FDA for inclusion 
in PAM II.
    The above methods 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 (MRLs) have 
been established for residues of azoxystrobin. Therefore, no tolerance 
discrepencies exist between countries for this chemical.

C. Conditions

    As conditions of registration of the use of azoxystrobin on the 
sites for which tolerances are being established in this rule, the 
registrant must submit the following:
    (1) In order to retain the use of the flowable concentrate 
formulation for late season uses the registrant must either submit 
separate crop field trials for the flowable concentrate or bridging 
data (side-by-side field trials) on representative crops for both the 
flowable concentrate and the water dispersible granule formulations of 
azoxystrobin.
    (2) The registrant must submit additional data on the frozen 
storage stability of azoxystrobin and its Z isomer in or on one 
representative crop each in the leafy vegetable group, the root and 
tuber vegetable group, and the processed commodities of a root and 
tuber vegetable group member.
    (3) Two additional spinach field trial studies that reflect the 
maximum proposed seasonal use pattern in each of two Regions must be 
submitted.
    (4) Additional rotational field crop studies using a higher 
application rate must also be submitted.

V. Conclusion

    Therefore, tolerances are established for the 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 barley, bran at 0.2 ppm; barley, grain at 0.1 ppm; barley, hay at 
15.0 ppm; barley, straw at 4.0 ppm; citrus, dried pulp at 2.0 ppm; 
citrus, oil at 4.0 ppm; coriander, leaves at 30.0 ppm; corn, field, 
forage at 12.0 ppm; corn, field, grain at 0.05 ppm; corn, field, 
refined oil at 0.3 ppm; corn, field, stover at 25.0 ppm; corn, pop, 
grain at 0.05 ppm; corn, pop, stover at 25.0 ppm; corn, sweet, forage 
at 12.0 ppm; corn, sweet (kernels plus cob with husks removed) at 0.05 
ppm; corn, sweet, stover at 25.0 ppm; cotton, gin byproducts at 0.02 
ppm; cotton, undelinted seed at 0.02 ppm; fruit, citrus, group at 1.0 
ppm; grain, aspirated grain fractions at 30.0 ppm; onion, dry bulb at 
1.0 ppm; onion, green at 7.5 ppm; peanut at 0.2 ppm; peanut, refined 
oil at 0.6 ppm; peanut, hay at 15.0 ppm; soybean, forage at 25.0 ppm; 
soybean, hay at 55.0 ppm; soybean, hulls at 1.0 ppm; soybean, seed at 
0.5 ppm; vegetable, leafy, except Brassica, group at 30.0 ppm; 
vegetable; leaves of root and tuber, group at 50.0 ppm; vegetable, 
root, subgroup at 0.5 ppm; and vegetable, tuberous and corm, subgroup 
at 0.03 ppm; and tolerances are increased for residues of azoxystrobin

[[Page 58413]]

(only) in or on cattle, fat to 0.03 ppm; cattle, meat byproducts to 
0.07 ppm; goat, fat to 0.03 ppm; goat, meat byproducts to 0.07 ppm; 
horse, fat to 0.03 ppm; horse, meat byproducts to 0.07 ppm; sheep, fat 
to 0.03 ppm; and sheep, meat byproducts to 0.07 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-301069 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 
28, 2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by 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-301069, 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 file format or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

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

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

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). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); special considerations as 
required by Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or require OMB review or 
any Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This action does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995

[[Page 58414]]

(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).

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 21, 2000.

James Jones,,

Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

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

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

    2. In Section 180.507, the table to paragraph (a)(1) is amended by 
revising the entries for ``peanut, hay'', and ``peanuts'', by adding 
new entries to read as set forth below, and by removing the entry for 
``peanut oil''; the table in paragraph (a)(2) is amended by revising 
the entries for ``cattle, fat''; ``cattle, meat byproducts''; ``goat, 
fat''; ``goat, meat byproducts''; ``horse, fat''; ``horse, meat 
byproducts''; ``sheep, fat''; and ``sheep, meat byproducts'', and in 
the table to paragraph (b) the entries for ``soybean hay''; ``soybean 
forage''; ``soybean hulls''; and ``soybean seed'' are removed.


Sec. 180.507   Azoxystrobin; tolerances for residues.

    (a) * * * 
    (1) * * * 

 
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
              *        *        *        *        *
Barley, bran...............................................          0.2
Barley, grain..............................................          0.1
Barley, hay................................................         15.0
Barley, straw..............................................          4.0
 
              *        *        *        *        *
Citrus, dried pulp.........................................          2.0
Citrus, oil................................................          4.0
Coriander, leaves..........................................         30.0
Corn, field, forage........................................         12.0
Corn, field, grain.........................................         0.05
Corn, field, refined oil...................................          0.3
Corn, field, stover........................................         25.0
Corn, pop, grain...........................................         0.05
Corn, pop, stover..........................................         25.0
Corn, sweet, forage........................................         12.0
Corn, sweet (K+CWHR).......................................         0.05
Corn, sweet, stover........................................         25.0
Cotton, gin byproducts.....................................         0.02
Cotton, undelinted seed....................................         0.02
 
              *        *        *        *        *
Fruit, citrus, group.......................................          1.0
Grain, aspirated grain fractions...........................         30.0
 
              *        *        *        *        *
Onion, dry bulb............................................          1.0
Onion, green...............................................          7.5
Peanut.....................................................          0.2
Peanut, refined oil........................................          0.6
Peanut, hay................................................         15.0
 
              *        *        *        *        *
Soybean, forage............................................         25.0
Soybean, hay...............................................         55.0
Soybean, hulls.............................................          1.0
Soybean, seed..............................................          0.5
 
              *        *        *        *        *
Vegetable, leafy, except Brassica, group...................         30.0
Vegetable, leaves of root and tuber, group.................         50.0
Vegetable, root, subgroup..................................          0.5
Vegetable, tuberous and corm, subgroup.....................         0.03
 
              *        *        *        *        *
------------------------------------------------------------------------

    (2) * * * 

 
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................         0.03
 
              *        *        *                *
Cattle, meat byproducts....................................         0.07
Goat, fat..................................................         0.03
 
              *        *        *        *        *
Goat, meat byproducts......................................         0.07
Horse, fat.................................................         0.03
 
              *        *        *        *        *
Horse, meat byproducts.....................................         0.07
 
              *        *        *        *        *
Sheep, fat.................................................         0.03
 
              *        *        *        *        *
Sheep, meat byproducts.....................................         0.07
------------------------------------------------------------------------

* * * * *

[FR Doc. 00-25051 Filed 9-28-00; 8:45 am]
BILLING CODE 6560-50-S