[Federal Register Volume 66, Number 225 (Wednesday, November 21, 2001)]
[Rules and Regulations]
[Pages 58400-58408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28971]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301190; FRL-6809-3]
RIN 2070-AB78


Azoxystrobin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation revises a time-limited tolerance for combined 
residues of azoxystrobin in or on the crop group Brassica leafy 
vegetables by limiting the listing to Head and Stem (Brassica) subgroup 
(subgroup 5A) and raising the residue level from 25 parts per million 
(ppm) to 30 ppm. This action is in response to EPA's granting of an 
emergency exemption under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide 
on cabbage. This regulation establishes a maximum permissible level for 
residues of azoxystrobin in this food commodity. The tolerance will 
expire and is revoked on December 31, 2003.

DATES: This regulation is effective November 21, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301190, 
must be received by EPA on or before January 22, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301190 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9364; and e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/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-301190. 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

[[Page 58401]]

and Records Integrity Branch (PIRIB), Rm. 119, Mall #2, 1921 Jefferson 
Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The PIRIB telephone number is (703) 
305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing a tolerance for combined residues of the 
fungicide azoxystrobin, [methyl(E)-2-(2-(6-(2-cyanophenoxt)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate] and the Z-isomer of azoxystrobin, 
[methyl(Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3 
methoxyacrylate], in or on Head and Stem (Brassica) subgroup at 30 ppm 
and removing the listing for Brassica vegetables at 25 ppm. This 
tolerance will expire and is revoked on December 31, 2003. EPA will 
publish a document in the Federal Register to remove the revoked 
tolerance from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to 
establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act (FQPA). 
EPA has established regulations governing such emergency exemptions in 
40 CFR part 166.

III. Emergency Exemption for Azoxystrobin on Cabbage and FFDCA 
Tolerances

    Alternaria Leafspot and Cercospora Leafspot are highly destructive 
fungi that can ruin fields of cabbage. Several rainstorms occurred in 
the affected area during the month of August with total rainfall 
exceeding 10 inches. It was feared that more warm wet weather could 
allow bacterial soft rot to invade damaged tissue and reduce both 
yields and quality during shipment. Texas issued a crisis exemption for 
the use of azoxystrobin to control Alternaria Leafspot (Alternaria 
brassicae) and Cercospora Leafspot (Cercospora Carotae) on cabbage.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of azoxystrobin in or on Head 
and Stem (Brassica) subgroup (subgroup 5A). In doing so, EPA considered 
the safety standard in FFDCA section 408(b)(2), and EPA decided that 
the necessary tolerance under FFDCA section 408(l)(6) would be 
consistent with the safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemption in 
order to address an urgent non-routine situation and to ensure that the 
resulting food is safe and lawful, EPA is issuing this tolerance 
without notice and opportunity for public comment as provided in 
section 408(l)(6). Although this tolerance will expire and is revoked 
on December 31, 2003, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on cabbage after that date will not be unlawful, 
provided the pesticide is applied in a manner that was lawful under 
FIFRA, and the residues do not exceed a level that was authorized by 
this tolerance at the time of that application. EPA will take action to 
revoke this tolerance earlier if any experience with, scientific data 
on, or other relevant information on this pesticide indicate that the 
residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether azoxystrobin 
meets EPA's registration requirements for use on cabbage or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of azoxystobin by a State for special local 
needs under FIFRA section 24(c). Nor does this tolerance serve as the 
basis for any State other than Texas to use this pesticide on this crop 
under section 18 of FIFRA without following all provisions of EPA's 
regulations implementing section 18 as identified in 40 CFR part 166. 
For additional information regarding the emergency exemption for 
azoxystrobin on cabbage in Texas, contact the Agency's Registration 
Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of 
azoxystrobin and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a time-limited tolerance for 
combined residues of azoxystrobin and its Z-isomer in or on Head and 
Stem (Brassica) subgroup at 30 ppm. EPA's assessment of the dietary 
exposures and risks associated with establishing the tolerance follows.

A. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological endpoint. However, the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved 
in the toxicology study selected. An uncertainty factor (UF) is applied 
to reflect uncertainties inherent

[[Page 58402]]

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 level of concern (LOC). For example, when 100 is the 
appropriate UF (10X to account for interspecies differences and 10X for 
intraspecies differences) the LOC is 100. To estimate risk, a ratio of 
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 X 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for azoxystrobin used for human risk assessment is shown in 
the following Table 1:

     Table 1.--Summary of Toxicological Dose and Endpoints for Azoxystobin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk       FQPA SF* and LOC for   Study and Toxicological
          Exposure Scenario                 Assessment, UF          Risk 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          Rat
                                       Acute RfD = 0.67 mg/kg/    FQPA SF.       (MRID 43678134,
                                        day.                    = 0.67 mg/kg/day.......   44182013, 44182015)
                                                                                         LOAEL = 200 mg/kg based
                                                                                          on diarrhea at two-
                                                                                          hours post dose at all
                                                                                          dose levels up to and
                                                                                          including 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 - Rat
                                                                                          (MRID 43678139)
                                                                                         LOAEL in males/females
                                                                                          = 34/117 mg/kg/day
                                                                                          based on reduced body
                                                                                          weights in both sexes
                                                                                          and bile duct lesions
                                                                                          in males.
----------------------------------------------------------------------------------------------------------------
Short-Term (1-7 days) Incidental Oral  NOAEL= 25 mg/kg/day      FQPA SF = 1X             Prenatal Developmental
(Residential)........................  UF = 100...............                            Oral Toxicity - Rat
                                                                                          (MRID 43678142)
                                                                                         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 - Rat
 months) Incidental Oral               UF = 100...............                            (MRID 43678135)
(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                     No dermal or systemic    21-Day Repeated Dose
 Dermal                                                          toxicity was seen at     Dermal - Rat (MRID
(Occupational/Residential)...........                            the limit dose (1,000    43678137)
                                                                 mg/kg/day). This risk
                                                                 assessment is not
                                                                 required.
----------------------------------------------------------------------------------------------------------------
Short-Term (1-7 days) Inhalation       Oral NOAEL= 25 mg/kg/    LOC for MOE = 100        Prenatal Developmental
(Occupational/Residential)...........   day                     (Occupational/            Oral Toxicity - Rat
                                       Use route-to-route        Residential).            (MRID 43678142)
                                        extrapolation                                    LOAEL = 100 mg/kg/day
                                        (inhalation absorption                            based on increased
                                        rate = 100%).                                     maternal diarrhea,
                                                                                          urinary incontinence,
                                                                                          and salivation.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term (1 week to several   Oral NOAEL= 20 mg/kg/    LOC for MOE = 100        90-Day Feeding - Rat
 months) Inhalation                     day                     (Occupational/            (MRID 43678135)
(Occupational/Residential)...........  Use route-to-route        Residential).           LOAEL = 211/223 mg/kg/
                                        extrapolation                                     day in males/females
                                        (inhalation absorption                            based on decreased
                                        rate = 100%).                                     body weight gain in
                                                                                          both sexes and
                                                                                          clinical signs
                                                                                          indicative of reduced
                                                                                          nutrition.
----------------------------------------------------------------------------------------------------------------

[[Page 58403]]

 
Long-Term (> 180 days) Inhalation      NOAEL = N/A              This risk assessment is
                                                                 not applicable to the
                                                                 use scenario 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.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.507) for the combined residues of azoxystrobin 
and its Z-isomer, in or on a variety of raw agricultural commodities. 
Tolerances are established on agricultural commodities at levels 
ranging from 0.01 ppm to 55.0 ppm; on meat, fat, and meat byproducts of 
cattle, goats, hogs, horses, and sheep at levels ranging from 0.01 ppm 
to 0.07 ppm; and on milk at 0.006 ppm. Tolerances were recently 
established on Brassica, leafy greens, subgroup. Time limited 
tolerances in connection with use under section 18 emergency exemptions 
on Brassica leafy vegetables are currently in effect at 25 ppm. Risk 
assessments were conducted by EPA to assess dietary exposures from 
azoxystrobin in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure. The Dietary Exposure Evaluation Model (DEEM) 
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: In conducting this acute dietary exposure 
analysis, EPA has made very conservative assumptions: all commodities 
having established or proposed azoxystrobin tolerances will contain 
azoxystrobin residues (i.e., 100% crop treated), and those residues 
will be at the level of the tolerance.
    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 
CSFII and accumulated exposure to the chemical for each commodity. The 
following assumptions were made for the chronic exposure assessments: 
In conducting this chronic dietary exposure analysis, EPA has made very 
conservative assumptions: all commodities having established or 
proposed azoxystrobin tolerances will contain azoxystrobin residues 
(i.e., 100% crop treated), and those residues will be at the level of 
the tolerance.
    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 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 Screening Concentration in Ground Water (SCI-GROW) model is used to 
predict pesticide concentrations in shallow ground water. For a 
screening-level assessment for surface water EPA will generally use 
FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The 
FIRST model is a subset of the PRZM/EXAMS model that uses a specific 
high-end runoff scenario for pesticides. While both FIRST and PRZM/
EXAMS incorporate an index reservoir environment, the PRZM/EXAMS model 
includes a percent crop area factor as an adjustment to account for the 
maximum percent crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a 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 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 exposure assumptions: 
Products containing azoxystrobin may

[[Page 58404]]

be applied to turf 1 to 5 times per year at rates up to 0.95 lb active 
ingredient (ai) per acre (i.e., not to exceed 5 lb ai per acre per 
year) and to ornamentals at rates up to 0.75 lb ai per acre every 7 to 
14 days, but not to exceed 5 lb ai per acre per 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- 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- and intermediate-term 
incidental oral exposures, respectively. These same NOAELs were 
selected for assessing the risks from short- and intermediate-term 
inhalation exposures. The LOC 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 PHED data for the garden hose-end 
sprayer scenario. The ORETF data were designed to replace the present 
Pesticide Handler Exposure Database (PHED) data 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 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).

C. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. 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.
    3. Conclusion. There is a complete toxicity data base for 
azoxystrobin and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. 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.

D. 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 + chronic non-dietary, non-occupational 
exposure)]. This allowable exposure through drinking water is used to 
calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to azoxystrobin in drinking water (when considered along with 
other sources of exposure for which EPA has reliable data) would not 
result in unacceptable levels of aggregate human health risk at this 
time. Because EPA considers the aggregate risk resulting from multiple 
exposure pathways associated with a pesticide's uses, levels of 
comparison in drinking water may vary as those uses change. If new uses 
are added in the future, EPA will reassess the potential impacts of 
azoxystrobin on drinking

[[Page 58405]]

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, 20% of the aPAD for 
children 1 to 6 years, the subpopulation at greatest exposure. In 
addition, despite the potential for acute dietary exposure to 
azoxystrobin in drinking water, after calculating DWLOCs and comparing 
them to conservative model EECs of azoxystrobin in 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, the subpopulation at greatest exposure. Based 
on the use pattern, chronic residential exposure to residues of 
azoxystrobin is not expected. In addition, despite the potential for 
chronic dietary exposure to azoxystrobin in drinking water, after 
calculating DWLOCs and comparing them to conservative model EECs of 
azoxystrobin in surface and ground water, EPA does not expect the 
aggregate exposure to exceed 100% of the cPAD, as shown in the 
following Table 3:

             Table 3.-- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Azoxystrobin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 cPAD  (mg/     % cPAD     Water EEC    Water EEC     Chronic
                                                   kg/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(s) 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 1,183 for adults and 490 for 
children 1 to 6 years. These aggregate MOEs do not exceed the Agency's 
LOC for aggregate exposure to food and residential uses. In addition, 
short-term DWLOCs were calculated and compared to the EECs for chronic 
exposure of azoxystrobin in ground water and surface water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect short-term aggregate exposure to 
exceed the Agency's LOC, as shown in the following Table 4:

                  Table 4.-- Aggregate Risk Assessment for Short-Term Exposure to Azoxystrobin
----------------------------------------------------------------------------------------------------------------
                                                  Aggregate                  Surface       Ground
              Population Subgroup                MOE (Food +   Aggregate    Water EEC    Water EEC    Short-Term
                                                Residential)      LOC         (ppb)        (ppb)     DWLOC (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 non-dietary, non-occupational exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Azoxystrobin is currently registered for use(s) that could result 
in intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and 
intermediate-term exposures for azoxystrobin.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food and 
residential exposures aggregated result in aggregate MOEs of 580 for 
children 1 to 6 years. These aggregate MOEs do not exceed the Agency's 
LOC for aggregate exposure to food and residential uses. In addition, 
intermediate-term DWLOCs were calculated and compared to the EECs for

[[Page 58406]]

chronic exposure of azoxystrobin in ground water 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 LOC, as shown in the following Table 5:

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

    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.

V. 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, PRRIB, 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 in or on the these 
commodities. Therefore, no tolerance discrepancies exist between 
countries for this chemical.

VI. Conclusion

    Therefore, the tolerance is revised 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 
Head and Stem (Brassica) subgroup at 30 ppm.

VII. Objections and Hearing Requests

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

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301190 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 January 
22, 2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental

[[Page 58407]]

Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by the docket control number OPP-301190, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VIII. Regulatory Assessment Requirements

    This final rule establishes a time limited tolerance under FFDCA 
section 408. The Office of Management and Budget (OMB) has exempted 
these types of actions from review under Executive Order 12866, 
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). 
Because this rule has been exempted from review under Executive Order 
12866 due to its lack of significance, this rule is not subject to 
Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under FFDCA section 408, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

IX. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
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: November 8, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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


[[Page 58408]]


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

    2. In Sec. 180.507, paragraph (b) is amended by revising the 
introductory text, and the entry for ``Brassica leafy vegetable'' in 
the table to read as follows:


Sec. 180.507  Azoxystrobin; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for the combined residues of the fungicide, azoxystrobin, 
[methyl (E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-
methoxyacrylate) and the Z isomer of azoxystrobin, [methyl (Z)-2-(2-(6-
(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate] in 
connection with use of the pesticide under section 18 emergency 
exemptions granted by EPA. The tolerances are specified in the 
following table. The tolerances expire and will be revoked by EPA on 
the date specified in the table.

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
                      *      *      *      *      *
Head and Stem (Brassica) subgroup.                 30           12/31/03
                      *      *      *      *      *
------------------------------------------------------------------------

* * * * *
[FR Doc. 01-28971 Filed 11-20-01; 8:45 am]
BILLING CODE 6560-50-S