Azoxystrobin; Pesticide Tolerances for Emergency Exemptions

[Federal Register: November 21, 2001 (Volume 66, Number 225)]
[Rules and Regulations]
[Page 58400-58408]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21no01-15]

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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:
pemberton.libby@epa.gov.

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 (MOE_cancer = 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:
furlow.calvin@epa.gov.

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 tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental

[[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: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 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

Azoxystrobin; Pesticide Tolerances for Emergency Exemptions

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